Unofficial translation
Footnote. The title is amended by the joint order of the Acting Minister of Health of the Republic of Kazakhstan dated 31.03.2025 № 27 and the Deputy Prime Minister - Minister of National Economy of the Republic of Kazakhstan dated 07.04.2025 № 16 (effective ten calendar days after the date of its first official publication).
In accordance with paragraphs 5 and 6 of Article 141, paragraph 1 of Article 143 of the Entrepreneurial Code of the Republic of Kazakhstan WE HEREBY ORDER:
Footnote. The preamble is in the wording of the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated 30.11.2022 № ҚР ДСМ-147 and the Minister of National Economy of the Republic of Kazakhstan dated 01.12.2022 № 115 (shall be enforced from 01.01.2023).1. To approve:
1) criteria for assessing the risk in the provision of medical services (aid) in accordance with Annex 1 to this joint order;
2) a checklist in the field of medical services (aid) in relation to entities (facilities) providing inpatient, inpatient replacement care in accordance with Annex 2 to this joint order;
3) a checklist in the field of medical services (aid) in relation to entities (facilities) providing outpatient care (primary health care and consultative diagnostic assistance) in accordance with Annex 3 to this joint order;
4) a checklist in the field of medical services (aid) in relation to entities (facilities) of maternity care and (or) inpatient organizations that include maternity and neonatal pathology departments in accordance with Appendix 4 to this joint order;
5) a checklist in the field of medical services (aid) in relation to entities (facilities) providing cardiological and cardiac surgical care in accordance with Annex 5 to this joint order;
6) a checklist in the field of medical services (aid) in relation to entities (facilities) providing hemodialysis care in accordance with Annex 6 to this joint order;
7) a checklist in the field of medical services (aid) in relation to entities (facilities) providing dental care in accordance with Annex 7 to this joint order;
8) a checklist in the field of medical services (aid) in relation to entities (facilities) providing phthisiological care in accordance with Annex 8 to this joint order;
9) a checklist in the field of medical services (aid) in relation to entities (facilities) providing oncological care in accordance with Annex 9 to this joint order;
10) a checklist in the field of medical services (aid) in relation to entities (facilities) providing medical and social assistance in the field of mental health in accordance with Annex 10 to this joint order;
11) a checklist in the field of medical services (aid) in relation to entities (facilities) providing laboratory services in accordance with Annex 11 to this joint order;
12) a checklist in the field of medical services (aid) in relation to entities (facilities) providing emergency medical care, medical assistance in the form of medical aviation in accordance with Annex 12 to this joint order;
13) a checklist in the field of medical services (aid) in relation to entities (facilities) engaged in activities in the field of HIV prevention in accordance with Annex 13 to this joint order;
14) a checklist in the field of medical services (aid) in relation to entities (facilities) operating in the field of blood services in accordance with annex 14 to this joint order;
15) criteria for assessing the risk in the field of circulation of medicines, medical devices and medical equipment in accordance with Annex 15 to this joint order;
16) a checklist in the field of circulation of medicines and medical devices for compliance with the qualification requirements for entities (facilities) of control in accordance with Annex 16 to this joint order;
17) a checklist in the field of circulation of medicines, medical devices and medical equipment in relation to medical organizations on issues of drug provision in accordance with Annex 17 to this joint order;
18) a checklist in the field of circulation of medicines, medical devices and medical equipment in relation to entities (facilities) of pharmaceutical activity engaged in the production of medicines, medical devices and medical equipment in accordance with Annex 18 to this joint order;
19) a checklist in the field of circulation of medicines, medical devices and medical equipment in relation to entities (facilities) of pharmaceutical activity engaged in the manufacture of medicines and medical devices in accordance with Annex 19 to this joint order;
20) a checklist in the field of circulation of medicines, medical devices and medical equipment in relation to entities (facilities) of pharmaceutical activity engaged in the wholesale sale of medicines, medical devices and medical equipment in accordance with annex 20 to this joint order;
21) a checklist in the field of circulation of medicines, medical devices and medical equipment in relation to entities (facilities) of pharmaceutical activity engaged in the retail sale of medicines, medical devices and medical equipment in accordance with appendix 21 to this joint order;
22) a checklist in the field of medical services (aid) in relation to entities (facilities) providing pathoanatomic diagnostics in accordance with annex 22 to this joint order;
23) a checklist in the field of medical services (aid) in relation to entities (facilities), regardless of their activities in accordance with annex 23 to this joint order;
24) a checklist in the field of medical services (aid) in relation to entities (facilities) providing assistance in the field of nuclear medicine in accordance with annex 24 to this joint order;
25) a checklist in the field of circulation of medicines and medical devices in relation to the state expert organization in the field of circulation of medicines and medical devices in accordance with annex 25 to this joint order;
26) a checklist in the field of medical services (aid) in relation to entities (facilities) providing medical care for occupational pathology in accordance with annex 26 to this joint order;
27) a checklist for provision of medical services (aid) to entities (facilities) providing medical care to persons held in pre-trial detention facilities and institutions of the penal enforcement (penitentiary) system in accordance with annex 27 to this joint order.
Footnote. Paragraph 1 is amended by the joint order of the Acting Minister of Health of the Republic of Kazakhstan dated 31.03.2025 № 27 and Deputy Prime Minister - Minister of National Economy of the Republic of Kazakhstan dated 07.04.2025 № 16 (effective ten calendar days after the date of its first official publication).2. To recognize invalid the joint order of the Minister of Healthcare and Social Development of the Republic of Kazakhstan dated December 29, 2015 № 1064 and the Minister of National Economy of the Republic of Kazakhstan dated December 29, 2015 № 831 "On approval of risk assessment criteria and checklists in the sphere of medical services quality, circulation of medicines, medical products and medical equipment "(registered in the Register of state registration of regulatory legal acts for the number 12763, published March 25, 2016 in the information and the legal system "Adіlet").
3. The committee of public health protection of the Ministry of Healthcare of the Republic of Kazakhstan shall ensure:
1) state registration of this joint order at the Ministry of Justice of the Republic of Kazakhstan;
2) within ten calendar days from the date of state registration of this joint order sending its copy in the Kazakh and Russian languages to the Republican state enterprise on the right of economic management "Republican Center for Legal Information" for official publication and inclusion into the Standard control bank of regulatory legal acts of the Republic of Kazakhstan;
3) placement of this joint order on the official Internet resources of the Ministry of Healthcare of the Republic of Kazakhstan and the Ministry of National Economy of the Republic of Kazakhstan after its official publication;
4) within ten working days after the state registration of this joint order in the Ministry of Justice of the Republic of Kazakhstan, submission of information on implementation of measures provided for in subparagraphs 1), 2) and 3) of this paragraph to the Legal department of the Ministry of Healthcare of the Republic of Kazakhstan.
4. Control over implementation of this joint order shall be entrusted on the Vice-Minister of Healthcare of the Republic of Kazakhstan.
5. This joint order shall be enforced upon expiry of ten calendar days after its first official publication.
| Minister of Healthcare | |
| of the Republic of Kazakhstan | E. Birtanov |
| Minister of National Economy | |
| of the Republic of Kazakhstan | T. Suleymenov |
"AGREED"
Committee on legal statistics
and special accounts
of General Prosecutor's office
of the Republic of Kazakhstan
| Appendix 1 to the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated November 15, 2018 № KR HCM-32 and the Minister of National Economy of the Republic of Kazakhstan dated November 15, 2018 № 70 |
Criteria for assessing the risk in provision of medical services (aid)
Footnote. Appendix 1 - as amended by the joint order of the Acting Minister of Health of the Republic of Kazakhstan dated 31.03.2025 № 27 and Deputy Prime Minister - Minister of National Economy of the Republic of Kazakhstan dated 07.04.2025 № 16 (effective ten calendar days after the date of its first official publication).
Chapter 1. General provisions
1. These Criteria for assessing the risks in provision of medical services (aid) (hereinafter – Criteria) have been developed in accordance with paragraphs 5 and 6 of Article 141 and paragraph 1 of Article 143 of the Entrepreneurial Code of the Republic of Kazakhstan, the Order of the Acting Minister of National Economy of the Republic of Kazakhstan dated June 22, 2022 № 48 "On approval of the Rules for the formation of a risk assessment and management system by regulatory state bodies and on amendments to the Order of the Acting Minister of National Economy of the Republic of Kazakhstan dated July 31, 2018 № 3 "On approval of the Rules for the formation by state bodies of a risk assessment system and a form of test sheets" (registered in the Register of state registration of regulatory legal acts under № 28577) and the order of the Acting Minister of National Economy of the Republic of Kazakhstan dated July 31, 2018 № 3 "On approval of the form of the checklist" (registered in the Register of state registration of regulatory legal acts under № 17371).
2. The following concepts are used in these Criteria:
1) score is a quantitative measure of risk calculation;
2) minor violations – violations of the requirements of the legislation of the Republic of Kazakhstan in the field of medical services (aid), non-compliance with which has led to and (or) may lead to formally committed, but not causing any harm to human life and health;
3) significant violations – violations, including non-compliance with the requirements of legislation in the field of medical services (aid), not related to gross and minor violations;
4) risk in the provision of medical services (aid) – the likelihood of harm to human life or health, the legitimate interests of individuals and legal entities, and the state as a result of the medical activities of the entity (object) of control;
5) gross violations – intentional or negligent clear and significant violation of the legislation of the Republic of Kazakhstan in the field of medical services (aid), non-compliance with which has caused and (or) may cause serious consequences to human health;
6) risk assessment and management system – the process of making managerial decisions aimed at reducing the likelihood of adverse factors by classifying the entities (objects) of control by degrees of risk for subsequent preventive control with visits to the entities (object) of control and (or) inspections for compliance with qualification requirements or licensing requirements for issued permits, requirements for sent notifications (further – verification of compliance with the requirements) in order to limit the freedom of entrepreneurship to the minimum possible extent, while ensuring an acceptable level of risk, as well as aimed at changing the level of risk for a particular entity (object) of control and (or) releasing such an entity (object) of control from preventive control with a visit to the entity (object) of control and (or) compliance checks;
7) objective criteria for assessing the degree of risk (hereinafter referred to as objective criteria) are criteria used to select entities (objects) of control depending on the degree of risk in the provision of medical services (aid) in carrying out activities and not directly dependent on an individual entity (object) of control;
8) subjective criteria for assessing the degree of risk (hereinafter referred to as subjective criteria) are criteria for assessing the degree of risk used to select entities (objects) of control for preventive control and verification of compliance with requirements, depending on the performance of a particular entity (object) of control.
3. The criteria for assessing the degree of risk for conducting a compliance check and preventive control with a visit to the entity (object) of control are formed by defining objective and subjective criteria.
Chapter 2. Objective criteria for assessing the risk for conducting compliance checks and preventive control of entities (objects) of control
4. Objective criteria are determined by determining the risk of state control, which is carried out taking into account one of the following criteria:
1) the level of danger (complexity) of the entity (object) depending on the activity carried out;
2) the scale and severity of the possible negative consequences of harm in the course of medical activity;
3) the possibility of adverse effects on human health, the legitimate interests of individuals and legal entities, and the state.
5. Based on the analysis of all possible risks, the entities (objects) of control are divided into three degrees of risk (high, medium and low).
The entities (objects) of high-risk control include organizations providing inpatient care (district hospital, numbered district hospital, multidisciplinary interdistrict hospital, city hospital, multidisciplinary city hospital, multidisciplinary city children's hospital, multidisciplinary regional hospital, multidisciplinary regional children's hospital), entities (objects) of obstetric care, entities (objects), providing hemodialysis care, emergency medical services and medical aviation organizations, organizations operating in the field of blood services, dental polyclinic (center, office), phthisiopulmonological organizations, cancer center or dispensary, nuclear medicine centers, disaster medicine organizations, healthcare organizations operating in the field of HIV infection prevention.
Entities (objects) of medium-risk control include entities (objects) providing primary health care (medical center, paramedic-obstetric center, outpatient clinic, primary health care center, numbered district polyclinic, district polyclinic, city polyclinic), entities (objects) providing specialized medical outpatient care, healthcare organizations performing pathoanatomic diagnostics, healthcare organizations performing laboratory diagnostics, inpatient organizations, providing medical care in the field of mental health, traditional medicine facilities.
Entities (objects) of low-risk control include entities (objects) of control providing restorative treatment and medical rehabilitation, and entities (objects) of control providing palliative care and nursing care.
6. In respect of entities (objects) of control classified as high and medium risk, compliance checks, preventive control with a visit to the entity (object) of control, preventive control without a visit to the entity (object) of control and an unscheduled inspection are carried out.
7. In respect of entities (objects) of control classified as low-risk, compliance checks, preventive control without visiting the entity (object) of control and an unscheduled inspection are carried out.
Chapter 3. Subjective criteria for assessing the risk for conducting compliance checks and preventive control of entities (objects) of control
8. The definition of subjective criteria is carried out using the following steps:
1) database formation and information collection;
2) information analysis and risk assessment.
9. The formation of a database and collection of information are necessary to identify entities (objects) of control that violate the legislation of the Republic of Kazakhstan.
The processes of collecting and processing information are fully automated and allow for the possibility of verifying the correctness of the data received.
10. The following sources of information are used to determine subjective criteria for assessing the degree of risks for conducting preventive control with a visit to the entity (object) of control:
1) the results of previous unscheduled inspections and preventive control with visits to the entities (objects) of control (in this case, the severity of violations is established in case of non-compliance with the requirements set out in the checklists);
2) the results of monitoring reports and information provided by the entity (object) of control;
3) the results of preventive control without visiting the entity (object) of control (final documents issued based on the results of preventive control without visiting the entity (object) of control).
11. The following information sources are used to determine the subjective criteria for assessing the degree of risks for conducting a compliance check:
1) the results of previous inspections in relation to the entities (objects) of control;
2) the results of certification and professional development of employees of entities (objects) of control over the past 5 years;
3) the availability of accreditation of entities (objects) of control with the urgency of the permits issued;
4) monitoring of reports and information provided by the entity (object) of control;
5) the results of the analysis of information provided by government agencies and organizations.
12. Based on the available sources of information, regulatory government agencies form subjective criteria to be evaluated.
The analysis and assessment of subjective criteria makes it possible to concentrate the verification of compliance with requirements and preventive control of the entity (object) of control in relation to the entity (object) of control with the greatest potential risk.
In terms of the degree of risk according to subjective criteria, the entity (object) of control refers to:
1) the high degree of risk – with a risk index from 71 to 100 inclusive;
2) the average degree of risk – with a risk index from 31 to 70 inclusive;
3) the low degree of risk – with a risk index from 0 to 30 inclusive.
At the same time, the data of subjective criteria previously taken into account and used in relation to a specific entity (object) of control or data for which the statute of limitations has expired in accordance with the Civil Code of the Republic of Kazakhstan are not applied in the analysis and assessment.
In respect of entities (objects) of control who have eliminated in full the violations issued based on the results of the previous preventive control with a visit and (or) verification of compliance with the requirements, it is not allowed to include them in the formation of schedules and lists for the next period of state control.
The priority of the sources of information used and the importance of indicators of subjective criteria are established in the criteria for assessing the degree of risk according to the list of subjective criteria for determining the degree of risk according to subjective criteria in the form according to the appendices 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 and 19 to these Criteria.
Indicators of subjective criteria are determined for each homogeneous group of entities (objects) of control. The specific weight of the indicators of subjective criteria is determined depending on the importance of the indicator in risk assessment for each homogeneous group of entities (objects) of control. Acceptable values of indicators of subjective criteria are regulated by regulatory legal acts of the Republic of Kazakhstan.
13. The degrees of violations of requirements in the field of medical services (aid) are divided into gross, significant and insignificant.
The requirements for conducting compliance checks and preventive control of the entities (objects) of control with a visit to the entity (object) of control with a classification according to the degree of significance of violations and sources of information are given in appendices 1 and 2 to these Criteria. Non-compliance with the requirement determines the appropriate degree of violations.
14. Entities (objects) of control are exempt from inspections for compliance with the requirements and preventive control of entities (objects) of control for the next calendar year if the entity (object) of control has conducted an external comprehensive assessment (accreditation) for compliance with accreditation standards and provided an accreditation certificate for the period under review.
15. Verification of compliance with the requirements and preventive monitoring with visits to the entity (object) are carried out depending on the purpose and types of activities of the facilities, in accordance with the checklists in the field of providing medical services (aid) to the population according to the appendices 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 22, 23, 24, 26 and 27 to this joint order.
16. Entities (objects) of control with a high degree of risk are transferred using an information system to a medium degree of risk or with a medium degree of risk to a low degree of risk in the relevant fields of activity of entities (objects) of control if there are cases of exemption from preventive control with a visit to the entity (object) of control or compliance checks in the laws of the Republic of Kazakhstan and criteria for assessing the degree of risk of regulatory state bodies.
17. When the control body draws up a schedule of inspections for compliance with the requirements and semi-annual lists of preventive control with visits to the entity (object) of control in respect of the same entities (objects) of control, uniform deadlines for the period of their conduct are established.
18. For entities (objects) of control classified as high-risk, the frequency of compliance checks is determined by the criteria for assessing the degree of risk, but not more than once a year.
For entities (objects) of control classified as medium risk, the frequency of compliance checks for compliance with requirements is determined by the criteria for assessing the degree of risk, but not more than once every two years.
For entities (objects) of control classified as low-risk, the frequency of inspections for compliance with requirements is determined by the criteria for assessing the degree of risk, but not more than once every three years.
Chapter 4. The procedure for calculating the degree of risk according to subjective criteria
19. In order to classify the entity (object) of control as a risk in accordance with paragraph 3 of these Criteria, the following procedure for calculating the risk indicator is applied.
20. The calculation of the risk index according to subjective criteria (R) is carried out in an automated mode by summing the risk index for violations based on the results of previous inspections and preventive control with visits to the entities (objects) (SP) of control and the risk index according to subjective criteria, followed by normalization of values given in the range from 0 to 100 scores.
Rпром = SP + SC, where
Rпром is an intermediate indicator of the degree of risk according to subjective criteria,
SP is an indicator of the degree of risk for violations,
SC is an indicator of the degree of risk according to subjective criteria.
The calculation is performed for each entity (object) of control of a homogeneous group of entities (objects) of control of each area of state control. At the same time, the list of assessed entities (objects) of control, attributed to a homogeneous group of entities (objects) of control of the same area of state control, forms a sample for subsequent normalization of data.
21. According to the data obtained from the results of previous inspections and preventive control with visits to the entities (objects) of control, an indicator of the degree of risk for violations is formed, estimated in scores from 0 to 100.
If one gross violation is detected by any of the sources of information specified in paragraphs 10 and 11 of these Criteria, the entity (object) of control is equated with a violation risk index (SP) of 100 scores and a compliance check and (or) preventive control with a visit to the entity (object) of control are carried out.
If no gross violations are detected, the risk index for violations is calculated as a total indicator for violations of significant and minor degrees.
When determining the indicator of significant violations, a coefficient of 0.7 is applied.
This indicator is calculated using the following formula:
SP3 = (SP2 x 100/SP1) x 0.7, where:
SP3 is an indicator of significant violations;
SP1 – the required number of significant violations;
SP2 – the number of significant violations detected;
When determining the indicator of minor violations, a coefficient of 0.3 is applied.
This indicator is calculated using the following formula:
SРн = (SP2 x 100/SP1) x 0.3, where:
SРн is an indicator of minor violations;
SP1 – the required number of minor violations;
SP2 – the number of minor violations detected;
The violation risk index (SP) is calculated on a scale from 0 to 100 scores and is determined by summing the indicators of significant and minor violations according to the following formula:
SP = SРз + SРн, where:
SP is the indicator of the degree of risk for violations;
SРз is an indicator of significant violations;
SРн is an indicator of minor violations.
The obtained value of the indicator of the degree of risk for violations is included in the calculation of the indicator of the degree of risk according to subjective criteria.
22. The risk index is calculated according to subjective criteria on a scale from 0 to 100 scores and is carried out according to the following formula:
Where,
xi is an indicator of the subjective criterion,
wi is the specific weight of the indicator of the subjective criterion xi,
n is the number of indicators.
The obtained value of the indicator of the degree of risk according to subjective criteria is included in the calculation of the indicator of the degree of risk according to subjective criteria.
If violations of the indicators of the subjective risk criterion are detected, which provides for automatic inclusion in the schedule of compliance checks and (or) the list of preventive control with a visit, the final risk indicator (R) of 100 scores is equated to the entity (object) of control and a compliance check and (or) preventive control with a visit to the entity (object) of control is carried out in respect of it.
23. The values calculated for entities (objects) according to the R indicator are normalized in the range from 0 to 100 scores. Data normalization is performed for each sample (sample) using the following formula:
R is an indicator of the degree of risk (final) according to the subjective criteria of an individual entity (object) of control.
Rmax is the maximum possible value on the scale of the degree of risk according to subjective criteria for entities (objects) included in the same sample (upper limit of the scale),
Rmin is the minimum possible value on the scale of the degree of risk according to subjective criteria for entities (objects) included in one sample (the lower limit of the scale),
Rпром is an intermediate indicator of the degree of risk according to subjective criteria, calculated in accordance with paragraph 20 of these Criteria.
24. The regulatory state body in the field of medical services (aid) provides, by May 1 of the current calendar year and by October 20 preceding the year of preventive control with a visit to the entity (object) of control, filling the information system with the necessary data intended for the formation of semi-annual lists of preventive control with a visit to the entity (object) of control and schedule for compliance with requirements in automatic mode.
| Annex 1 to the Risk assessment criteria in the sphere of provision of medical service (assistance) |
Degrees of violations of the requirements for compliance inspection of the subjects (objects) of control
Item № | Name of requirements | Degree of violations |
1 | Availability of a specialist certificate for admission to clinical practice | gross |
2 | Availability of a license and (or) an annex to the license | gross |
3 | Compliance of the premises or building on the right of ownership or lease agreement, or contract of gratuitous use of immovable property (loan), or trust management of property, or public-private partnership agreement with the standards of organization of medical care of specialized services for the provided subspecialties of medical activity, as well as the corresponding sanitary rules establishing sanitary and epidemiological requirements for the objects of health cate | gross |
4 | Availability of functioning medical and (or) special equipment, apparatus and instruments, devices, furniture, inventory, transport and other means (if necessary), approved in the standards of organization of medical care of profile services for the provided subspecialties of medical activity and minimum standards of equipment of health care organizations with medical products | gross |
5 | Availability of specialists for the provided types of activities | gross |
6 | Availability of specialization or improvement and other types of advanced training for the last 5 (five) years on the provided subtypes of medical activity (except for the graduates of internship, residency, secondary educational institution who have completed their training not later than 5 (five) years at the time of inspection). | gross |
| Annex 2 to the Risk assessment criteria in the sphere of provision of medical service (assistance) |
Degrees of violations of requirements for preventive control of the subjects (objects) of control
Item № | Name of requirements | Degree of violations |
For obstetric facilities and (or) inpatient organizations with maternity wards and neonatal pathoanatomical departments | ||
1 | Availability of an opinion on the compliance of the subject of health care to the provision of high-tech medical care when the organization provides high-tech services, including in vitro fertilization | gross |
2 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | gross |
3 | Availability of a written voluntary consent of the patient or his/her legal representative for invasive interventions and therapeutic and diagnostic measures | significant |
4 |
Availability of supporting documentation (emergency medical team call card form № 085/y, register of admissions and refusals to hospitalization, medical card of an inpatient form № 001/y), that the stay of an ambulance or emergency medical services team in the emergency room of a hospital does not exceed 10 minutes (time for transferring the patient to the doctor of the emergency room) from the moment of its arrival at the hospital, except when emergency medical care is needed in emergency situations. | gross |
5 |
Presence of a medical report issued by the doctor of the emergency room with a written justification of refusal in the absence of indications for hospitalization in a health care organization. | significant |
6 |
Availability of supporting records in medical documentation on indications for hospitalization: | significant |
7 | Availability of records in the medical documentation on the examination of severe patients by the head of the department on the day of hospitalization, and daily thereafter. Patients in a moderately severe condition are examined at least once a week. Availability of the results of the patient's examination recorded in the medical card with recommendations on further tactics of patient management with mandatory identification of the medical worker making the records | significant |
8 | Availability of records in medical documentation confirming daily examination of inpatients by the attending physician, except for weekends and holidays. Availability of appropriate records in the medical card in case of examination and prescription of additional diagnostic and treatment manipulations by the doctor on duty | significant |
9 | Availability of justification in the medical card for dynamic assessment of the patient's condition according to clinical protocols of diagnosis and treatment in case of identification of the fact of additional and repeated tests conducted before hospitalization in primary health care organizations or other health care organizations, for medical reasons | significant |
10 |
Availability of supporting documentation that the following requirements have been met when issuing a maternity leave and certificate of temporary incapacity for pregnancy and childbirth: | significant |
11 |
Availability of medical documentation on compliance with the following requirements for the examination of temporary incapacity for work, issuance of certificates and certificates of temporary incapacity for work (Form № 001/y "Medical card of an inpatient", form 052/y "Medical card of an outpatient", stubs of certificates of temporary incapacity for work of patients, form № 025/y "Register for Recording Conclusions of Medical Consultative Board", form № 029/y "Book of registration of certificates of temporary incapacity for work", form № 037/y "Certificate №__________ on temporary incapacity of a student, college student, vocational school, illness, quarantine and other reasons for the absence of a child attending school, pre-school organization (underline)", form № 038/y "Certificate №______ on temporary incapacity" etc.): | significant |
12 | Availability of informed written consent of the patient for transfusion of blood components | significant |
13 |
Availability of records in medical documentation on compliance with the requirements for transfusion of blood components. | Gross |
14 |
Availability of documentation on compliance with the following when performing post-mortem examination: | gross |
15 |
Availability of supporting documentation on compliance with the following requirements in the organization of obstetric and gynecological care at the outpatient and polyclinic level: | gross |
16 | The use of germ cells, tissues of reproductive organs by a recipient who is (are) married (matrimonial) shall be carried out with the written consent of both spouses. | minor |
17 | Availability of supporting documentation of the birth of ten (10) children from a single donor 6 which is the basis for discontinuing the use of that donor for recipients. | significant |
18 |
Availability of supporting documentation on donation of germ cells, tissues of reproductive organs from the donor under the following conditions: | significant |
19 | Oocyte donation shall be carried out in the presence of a written informed consent of the donor for superovulation induction or in a natural cycle in compliance with the requirements for donors of germ cells, tissues of reproductive organs and donors of oocytes undergo medical and genetic examinations | significant |
20 |
Availability of supporting documentation for in vitro fertilization (hereinafter referred to as the IVF) with the use of donor oocytes is carried out according to the indications: | gross |
21 | Availability of supporting documentation on work with donors by an obstetrician-gynecologist (reproductologist), medical examination of the donor before each procedure of donor material collection, controls the timeliness and results of laboratory tests in accordance with the calendar plan of examination. | significant |
22 |
Availability of supporting documentation on oocyte donation according to the following algorithm: | significant |
23 |
Availability of supporting documentation on compliance with the requirements for denial of IVF using donor oocytes for the following contraindications: | gross |
24 |
Availability of supporting documentation on the use of donor sperm in assisted reproductive methods and technologies (hereinafter referred to as ARMT)). Sexual abstinence for 3-5 days is required before semen donation. Semen is obtained by masturbation. The ejaculate is collected in a special sterile, pre-labeled container. This procedure is carried out in a special room with a separate entrance, appropriate interior, sanitary unit with a washbasin. In the absence of donor sperm in the medical organization, or at the patient's request, donor sperm from other organizations that have a donor sperm bank is used. | significant |
25 |
IVF with the use of donor sperm is performed in the following indications | gross |
26 | The individual donor card is filled out and coded by a doctor. The coding scheme is free. The donor's application and his/her individual card shall be kept in a safe as documents for official use. | significant |
27 |
Availability of supporting documentation of work with donors by a doctor-uroandrologist and a doctor-embryologist. The doctor organizes medical examinations of the donor, controls the timeliness and results of laboratory tests in accordance with the calendar plan of examination. | significant |
28 |
Availability of supporting documentation of compliance, that the embryo donors are IVF patients who have unused cryopreserved embryos left in the bank. By free decision and written informed consent of the patients, these embryos are disposed of or donated to a medical organization. Embryos transferred to the medical organization are used for donation free of charge to infertile married couple, women (recipients) who are not married (matrimonial). | gross |
29 | Availability of supporting documentation on compliance with assisted reproductive techniques and technologies | gross |
30 |
Availability of supporting documentation of the following functions in the provision of pre-hospital care to women during and outside pregnancy by paramedics (obstetricians, paramedics, nurses/nurses): | gross |
31 |
Availability of supporting documentation on compliance with the following requirements when organizing obstetric and gynecological care at the inpatient level: | gross |
Providing medical care to newborns | ||
32 |
Availability of supporting documentation on compliance with the following requirements when organizing medical care for newborns at the inpatient level: | gross |
33 |
Availability of supporting documentation on compliance with the requirements for the provision of medical care to newborns in third-level medical organizations: | gross |
34 | Availability of supporting documentation on compliance with requirements to provide a healthy newborn with basic care that includes prevention of hypothermia with "heat chain" compliance, skin-to-skin or skin-to-skin contact with the mother, early initiation of breastfeeding within the first hour (if the infant shows signs of readiness), and prevention of hospital-acquired infections | significant |
35 | Availability of supporting documentation on compliance with requirements to perform healthy newborn anthropometry, full examination and other measures 2 hours after delivery | significant |
36 | Availability of supporting documentation on compliance with the requirements of emergency medical care in case of detection of disorders of the newborn's condition, transfer to the intensive care ward or neonatal intensive care unit, if indicated | gross |
37 |
Availability of supporting documentation on compliance with requirements for observation of the mother and healthy newborn in the delivery room by an obstetrician within two hours of birth: | significant |
38 | Availability of supporting documentation on compliance with transfer 2 hours after birth of a healthy newborn with the mother to a mother-and-child care unit | significant |
39 | Availability of supporting documentation on round-the-clock observation by medical staff and continuous involvement of the mother in the care of the child, except in cases of moderate and severe maternal conditions in the postpartum ward in the mother-and-child wards | significant |
40 | Availability of supporting documentation on compliance with the requirements for dynamic monitoring of the newborn with timely detection of violations of the newborn's condition, conducting the necessary examination, examination by the head of the department, organization of a concilium to clarify the tactics of management. Provision of emergency medical care when indicated, timely transfer to the intensive care ward or neonatal intensive care unit | gross |
41 |
Compliance with the requirements for medical workers in the wards of joint stay of mother and child: | significant |
42 | Availability of records in medical documentation on daily examination of newborns by a neonatologist, consultations with mothers on care, prevention of hypothermia and vaccinations | significant |
43 | Availability of supporting documentation on compliance with the requirements for the organization of consultations by specialized professionals, with treatment and diagnostic measures and recommendations to the mother on examination, treatment and rehabilitation in the presence of three or more micro anomalies of development or detection of congenital pathology of newborns | gross |
44 | Availability of supporting documentation on compliance with the requirements of medical care in case of emergency conditions in the newborn (asphyxia, respiratory distress syndrome etc.) stabilization of its condition and determination of the degree of readiness for transportation with the mother to the second or third level obstetrics organization | gross |
45 | Availability of supporting documentation on vaccination of newborns on the basis of voluntary informed consent of parents (mother, father or legal representatives) for prophylactic vaccinations within the timeframe of prophylactic vaccinations in the Republic of Kazakhstan. | gross |
46 | Availability of supporting documentation on compliance with requirements for all newborns to undergo neonatal screening for phenylketonuria, congenital hypothyroidism and audiologic screening prior to discharge | gross |
47 | Availability of supporting documentation on compliance with the requirements for neonatologist's assessment of the severity of the condition, stabilization of the condition, assessment of the degree of readiness for transportation in case of emergencies in the newborn, and organization of its transfer with the mother (in coordination with the obstetrician-gynecologist) to the second or third level medical organization | gross |
48 | Availability of supporting documentation on compliance with the requirements in case of suspicion and (or) detection of acute surgical pathology in a newborn baby, in case of emergency consultation of a doctor specializing in “Pediatric surgery (neonatal surgery)”. After stabilization of vital signs, the newborn shall be transferred to a surgical department of another medical organization (children's or multidisciplinary hospital) or to a neonatal (or children's) surgical department, if there shall be one in the structure of the obstetric medical organization, to provide him/her with appropriate specialized medical care | gross |
49 | Availability of supporting documentation on compliance with the requirements for transfer to a pediatric inpatient facility for premature newborns after 28 days of age or premature newborns after post-conceptional age of 42 weeks who require further 24-hour medical care | significant |
50 | Availability of mandatory post-mortem examination of the fetus and placenta in cases of medically indicated termination of pregnancy for suspected congenital anomalies in the fetus | gross |
51 | Availability of documentation on clinical and pathoanatomical review of all maternal and infant deaths after completion of all pathological investigations | gross |
52 | Availability of an agreement for provision of paid medical services in health care organizations. Availability of documents establishing the fact of co-payment | gross |
53 | Availability of medical documentation on consultation with a pediatric cardiologist (cardiac surgeon) when a congenital malformation of the cardiovascular system is detected in obstetrics organizations, and if medically indicated, transfer of the newborn to a specialized hospital | gross |
54 | Availability of medical documentation on the use of opportunities for consultation with specialized national organizations, through telemedicine network in case of difficulty in verifying the diagnosis of the child, determining the tactics of management. If it is necessary to transfer the child to specialized republican organizations. | significant |
55 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical briefs) of the clinical audit by Patient Support Services and internal expertise and its evaluation according to the following criteria: | significant |
Requirements for subjects (objects) providing inpatient, inpatient substitution care | ||
56 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | gross |
57 | Availability of an opinion on the compliance of the healthcare entity to provide high-tech medical care | gross |
58 | Availability of a written voluntary consent of the patient or his/her legal representative for invasive interventions and therapeutic and diagnostic measures | significant |
59 |
Availability of supporting documentation (form № 085/y “emergency medical team call card”, register of admissions and refusals to hospitalization, form № 001/y “medical card of an inpatient”), that the stay of the EMS team or EMS department when organizing primary health care in the emergency room of the hospital does not exceed 10 minutes (time for transferring the patient to the doctor of the emergency room) from the moment of its arrival in the hospital, except for the need for emergency medical care in emergency situations. | gross |
60 | Availability of supporting medical documentation (form №001/y “Medical Card of Inpatient”) on hospitalization of a severe patient who needs constant monitoring of vital functions for medical reasons, by decision of the concilium and notification of the heads of health care organizations with subsequent transfer to another medical organization on the profile of the disease for further examination and treatment after stabilization of the condition | significant |
61 |
Availability of supporting documentation on the medical opinion of the emergency room doctor with a written justification of the refusal in the absence of indications for hospitalization in a health care organization (Journal of admissions and refusals of hospitalization from medical information systems, certificate in form №027/y (refusals of hospitalization)). | significant |
62 |
Availability of records in medical documentation (Register of patient admission and refusals of hospitalization from the MIS, scheduled hospitalization coupons, “Medical card of an inpatient” (form №001/y) on indications for hospitalization: | significant |
63 | Availability of supporting medical documentation (Form № 001/y “Medical Card of Inpatient”) on the examination of heavy patients by the head of the department on the day of hospitalization, and daily thereafter. Patients in a moderately severe condition are examined at least once a week. The results of the examination of the patient are recorded in the medical card with recommendations on further tactics of patient management with the obligatory identification of the medical worker making the entries | significant |
64 | Availability of the established clinical diagnosis in conjunction with the head of the department no later than three calendar days from the day of hospitalization of the patient in the health care organization in the form № 001/y “Medical Card of Inpatient”. | significant |
65 |
Availability of supporting documentation (Form № 001/y “Medical Card of Inpatient”) on daily examination of patients in the hospital by the attending physician, except for weekends and holidays. In case of examination and appointment of additional diagnostic and therapeutic manipulations by the doctor on duty, appropriate entries are made in the medical card. If the patient's condition worsens, the doctor on duty shall notify the head of the department and (or) the attending physician, agree on changes in the process of diagnosis and treatment, and make an entry in the medical card (paper and (or) electronic) version. | significant |
66 |
Compliance with requirements for planned hospitalization: | significant |
67 | Availability of medical records of consultations or conciliums in case of difficulty in identifying the diagnosis, ineffectiveness of the current treatment, as well as other indications | gross |
68 |
Availability of medical documentation of compliance with discharge criteria, such as: | significant |
69 | Availability of a discharge epicrisis to the patient upon discharge, indicating the full clinical diagnosis, the scope of diagnostic tests, therapeutic measures and recommendations for further follow-up and treatment. The data on discharge shall be entered into the information systems on a day-to-day basis, indicating the actual time of discharge. | minor |
70 |
Availability of documentation on compliance with the requirements for transfusion of blood components and in case of complications (orders on the establishment of the commission, algorithm of interaction of staff, “Medical card of an inpatient” form № 001/y): | gross |
71 |
Availability of supporting medical documentation on the indications for hospitalization in day hospital at outpatient and polyclinic health care organizations and in hospital at home: | significant |
72 |
Availability of medical documentation on the examination of persons for clinical indications of HIV infection upon detection of the following diseases, syndromes and symptoms: | gross |
73 | Availability of an agreement for provision of paid medical services in health care organizations. Availability of documents establishing the fact of co-payment | gross |
74 |
Availability of medical documentation on compliance with the following requirements for the examination of temporary incapacity for work, issuance of a sheet and certificate of temporary incapacity for work (Form № 001/y “Medical Card of Inpatient”, form 052/y “Medical Card of Outpatient”, stubs of sheets on temporary incapacity of patients, form № 025/y “Register for Recording Conclusions of Medical Consultative Board”, form № 029/y "Book of Registration of certificates of temporary incapacity for work”, form № 037/y “Certificate №__________ on temporary incapacity of a student, college or vocational school pupil, sickness, quarantine and other reasons for absence of a child attending school or pre-school organization (underline as necessary)", form № 038/y "Certificate №______ on temporary incapacity" and other): | significant |
75 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical reports) of the clinical audit conducted by the Patient Support Service and internal expertise and its evaluation according to the following criteria: | significant |
76 |
Availability of documentation on compliance with the following steps for post-mortem examinations: | gross |
77 | Availability of a written application of the spouse, close relatives or legal representatives of the deceased or a written will issued by the person during his/her lifetime to release the corpse without post-mortem examination, if there is no suspicion of death through violence | significant |
78 | Availability of a record by a medical worker in the medical documentation with subsequent collection of biological materials to determine the content of a psychoactive substance and recording the results in the medical card when signs of psychoactive substance use are detected during the application for medical assistance to a health care organization without issuing a medical examination conclusion to establish the fact of psychoactive substance use and state of intoxication. | minor |
79 | Availability of medical documentation on treatment and diagnostic measures, drug provision, organization of therapeutic nutrition and appropriate care of the patient from the moment of admission to the health care organization (Medical card of inpatient” form № 001/y) | significant |
80 | Availability of medical documentation on the use of opportunities for consultation with specialized national organizations, through telemedicine network in case of difficulty in verifying the diagnosis of the child, determining the tactics of management. If necessary, the child shall be transferred to specialized republican organizations. | significant |
81 | Availability of medical documentation on the provision of supportive care (support for adequate feeding, water balance, pain control, fever management, oxygen therapy) | significant |
82 | Availability of medical documentation of the use of less painful alternative treatments, if available, that are as effective, to avoid unnecessary painful procedures | significant |
83 | Availability of medical documentation on daily examination of the child by a doctor, examination by the head of the department (on admission on the first day, repeatedly at least once a week) | significant |
84 |
Availability of medical documentation on compliance with the requirements of anesthesiology and resuscitation care: | significant |
85 | Availability of medical documentation on compliance of treatment and diagnostic measures with the recommendations of clinical protocols | significant |
86 | Availability of medical documentation on provision of the first stage of medical rehabilitation for the main disease (form № 001/y “Medical card of inpatient”, “form № 047/y” rehabilitation card). | significant |
87 | Availability of medical documentation on the examination by the head of the department upon admission of neurosurgical patients and subsequently on the necessity of the disease (Medical card of inpatient form № 001/y) | significant |
Requirements for the subjects (objects) providing outpatient and polyclinic care (primary health care and consultative-diagnostic care) | ||
88 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | Gross |
89 | Presence of written voluntary consent of the patient or his/her legal representative for invasive interventions and therapeutic and diagnostic measures | significant |
90 | Availability of medical records of an outpatient on compliance of treatment and diagnostic measures with recommendations of clinical protocols | significant |
91 |
Availability of documentation on compliance with the following requirements when organizing and conducting a medical consultative board: | significant |
92 |
Availability of documentation on compliance by primary health care organizations in conducting preventive medical examinations of target population groups: | significant |
93 |
Availability of documentation on compliance with the levels of provision of medical rehabilitation to patients: | significant |
94 |
Availability of documentation on compliance of TB care at the outpatient and polyclinic level with the following requirements: | gross |
95 |
Availability of documentation on compliance with the requirements for oncologic care in the form of outpatient care: | significant |
96 7 | Availability of mandatory confidential medical screening for HIV infection of persons on clinical and epidemiological indications, including sexual partners of pregnant women, persons who applied voluntarily and anonymously | significant |
97 |
Availability of documentation on compliance with the requirements of the following activities by an obstetrician-gynecologist when a woman first applies for pregnancy and wishes to keep it: | significant |
98 |
Availability of documentation on compliance with the requirements of an obstetrician-gynecologist for the provision and organization of obstetric and gynecological care to women during pregnancy, after childbirth, provision of family planning and reproductive health services, as well as prevention, diagnosis and treatment of gynecological diseases of the reproductive system | gross |
99 | Availability of results and additional data of follow-up examinations and investigations in the Individual Card of a pregnant and postpartum woman and the Exchange Card of a pregnant and postpartum woman at each visit of a pregnant woman to an obstetrician-gynecologist | significant |
100 | Availability of home care by a midwife or foster nurse for pregnant women, who do not show up for an appointment within 3 days after the scheduled date | significant |
101 | Availability of the conclusion of the medical consultative board on possible pregnancy in women with contraindications to pregnancy due to extragenital pathology | significant |
102 | Availability of an agreement for provision of paid medical services in health care organizations. Availability of documents establishing the fact of co-payment | gross |
103 |
Availability of documentation on compliance by the paramedical staff of the medical unit of the educational organization with the following requirements: | significant |
104 |
Availability of medical documentation on compliance with the following requirements for the examination of temporary incapacity for work, issuance of a sheet and certificate of temporary incapacity for work (Form № 001/y “Medical Card of Inpatient”, form 052/y “Medical Card of Outpatient”, stubs of sheets on temporary incapacity of patients, form № 025/y “Register for Recording Conclusions of Medical Consultative Board”, form № 029/y "Book of Registration of certificates of temporary incapacity for work”, form № 037/y “Certificate №__________ on temporary incapacity of a student, college or vocational school pupil, sickness, quarantine and other reasons for absence of a child attending school or pre-school organization (underline as necessary)", form № 038/y "Certificate №______ on temporary incapacity" and other): | significant |
105 |
Compliance with the following requirements when issuing a sick leave certificate and certificate of temporary incapacity for work for maternity: | significant |
106 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical briefs) of the clinical audit by Patient Support Services and internal expertise and its evaluation according to the following criteria: | significant |
107 | Availability of documentation on compliance with the requirements to provide a guaranteed volume of free medical care | gross |
108 |
Availability of documentation on compliance with the requirements of surgical (abdominal, thoracic, coloproctological) care to patients at the outpatient and polyclinic level | gross |
109 | Availability of documentation on compliance with the requirements of primary health care organizations for dynamic monitoring of persons with chronic diseases, compliance with the frequency and timing of observation, the mandatory minimum and frequency of diagnostic tests | significant |
110 | Documentation of compliance with requirements for active home visits by primary health care staff | significant |
111 |
Availability of documentation on compliance with pediatric care requirements: | significant |
112 |
Availability of documentation on compliance with the requirements for traumatological and orthopedic care at the outpatient and polyclinic level | significant |
113 |
Availability of documentation on compliance with the requirements of neurological care at the outpatient and polyclinic level | significant |
114 |
Availability of documentation of compliance with nephrology care, which includes: | gross |
115 |
Availability of documentation on compliance with the requirements of neurosurgical care in outpatient settings | significant |
116 |
Availability of documentation on compliance with the requirements of neurological care at the outpatient and polyclinic level | significant |
117 | Reasoned registration of the notification on the expert opinion of medical and social assessment, form № 031/y (availability of data for a comprehensive assessment of the state of the organism and the degree of restriction of vital activity) | gross |
Requirements for subjects (objects) providing cardiologic, cardiac surgical care | ||
118 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | Gross |
119 | Availability of medical documentation on compliance of treatment and diagnostic measures with the recommendations of clinical protocols | Significant |
120 | Availability of a written voluntary consent of the patient or his/her legal representative for invasive interventions and therapeutic and diagnostic measures | significant |
121 |
Availability of supporting documentation (emergency medical team call card form № 085/y, register of admissions and refusals of hospitalization, Medical card of inpatient form № 001/y) that the stay of the CEMS or EMS team when organizing primary health care in the emergency room of the hospital does not exceed 10 minutes (time for transferring the patient to the doctor of the emergency room) from the moment of its arrival in the hospital, except for cases of emergency medical care in emergency situations. | Gross |
122 | Availability of documentation on ensuring hospitalization of a severe patient in need of constant monitoring of vital functions for medical reasons, by decision of the concilium and notification of the heads of health care organizations with subsequent transfer to another medical organization according to the profile of the disease for further examination and treatment after stabilization of the condition | significant |
123 |
A medical report with a written justification of refusal in the absence of indications for hospitalization in a health care organization is issued to the patient by the doctor of the reception department. | significant |
124 |
Availability of supporting documentation on indications for hospitalization: | significant |
125 | Availability of examination of severe patients by the head of the department on the day of hospitalization, and daily thereafter. Patients in a moderately severe condition are examined at least once a week. The results of the patient's examination are recorded in the medical card with recommendations on further tactics of patient management with obligatory identification of the medical worker making the entries | significant |
126 | Availability of supporting documentation on the establishment of the main diagnosis in emergency conditions within 24 (twenty-four) hours from the moment of the patient's admission to a 24-hour hospital on the basis of clinical and anamnestic examination data, results of instrumental and laboratory methods of research with entry in the medical card of an inpatient in form № 001/y, in stable patients - availability of the established clinical diagnosis in conjunction with the head of the department no later than three calendar days from the date of hospitalization | significant |
127 |
Availability of supporting documentation of planned hospitalization in the presence of indicators: | significant |
128 |
Availability of documentation on urgent (round-the-clock, including weekends and holidays) procedures, in particular: | significant |
129 | Availability of documentation on hospitalization to the catheterization laboratory, bypassing the admission department, intensive care unit (ward) if the patient is diagnosed with acute coronary syndrome with segment elevation, acute myocardial infarction | significant |
130 |
Availability of documentation on ensuring daily examination by the attending physician of patients in the hospital except for weekends and holidays. When examining and prescribing additional diagnostic and therapeutic manipulations by the doctor on duty, appropriate entries are made in the medical record. In case of deterioration of the patient's condition, the doctor on duty shall notify the head of the department and (or) the attending physician, agree on changes in the process of diagnosis and treatment, and make an entry in the medical card (paper and (or) electronic) option. | significant |
131 | Availability of documentation on the assessment of the complexity of surgical interventions for congenital heart disease using the Aristotle Basic Scale and the effectiveness of operations in the cardiac surgical unit | significant |
132 |
Availability of documentation on compliance of medical care provision to patients with acute coronary syndrome and (or) acute myocardial infarction by levels of regionalization: | significant |
133 |
Availability of supporting documentation of compliance for planned hospitalization: | significant |
134 | Availability of a conclusion of consultations or the concilium in case of difficulty in identifying the diagnosis, ineffectiveness of the current treatment, as well as in other indications | significant |
135 |
Availability of supporting documentation during hospitalization at the inpatient level: | significant |
136 | Ensuring that a discharge summary is issued to the patient upon discharge, indicating the full clinical diagnosis, the scope of diagnostic tests, therapeutic measures and recommendations for further follow-up and treatment. Discharge data shall be entered into the information systems on a day-to-day basis, indicating the actual time of discharge | significant |
137 |
Availability of documentation of adherence to discharge criteria, specifically: | significant |
138 | Availability of an agreement for provision of paid medical services in health care organizations. Availability of documents establishing the fact of co-payment | gross |
139 |
Documentation of compliance with blood component transfusion requirements and in case of complications: | gross |
140 |
Presence of examination of persons on clinical indications for HIV infection upon detection of the following diseases, syndromes and symptoms: | gross |
141 |
Availability of medical documentation on compliance with the following requirements for the examination of temporary incapacity for work, issuance of a sheet and certificate of temporary incapacity for work (form №001/y "Medical card of inpatient", form 052/y "Medical card of outpatient", stubs of patients' certificates of temporary incapacity for work, form № 025/y Register for Recording Conclusions of Medical Consultative Board, form № 029/y "Book of Registration of certificates of temporary incapacity for work”, form № 037/y “Certificate №__________ on temporary incapacity of a student, college or vocational school pupil, sickness, quarantine and other reasons for absence of a child attending school or pre-school organization (underline as necessary)", form № 038/y "Certificate №______ on temporary incapacity" and other): | significant |
142 |
Compliance with the following requirements in the organization and conduct of the medical consultative board: | significant |
143 |
Availability of supporting documentation on the indications for hospitalization in day hospital at outpatient and polyclinic health care organizations and in hospital at home: | significant |
144 | Availability of a recovery and rehabilitation department | significant |
145 | Availability of a cardiology room in the structure of organizations providing outpatient care to the population (district, city, region, republic) and organizations providing in-patient care | significant |
146 | If it is impossible to establish the diagnosis of CDV in a primary health care organization, referral of the patient for consultation in a clinical diagnostic center for the provision of diagnostic assistance, with a consultation, if necessary, with the involvement of specialized professionals, including consultants from medical organizations at the republican level. | significant |
147 | Availability of supporting documentation of consultative diagnostic assistance provided to a patient with CDV by a specialized professional referred by a PHC specialist or another specialized professional | significant |
148 | availability of an opinion on execution of documents for referral for medical and social assessment in the presence of high blood pressure (crisis course), arrhythmia of various genesis, increased frequency of angina attacks and increasing symptoms of heart failure, issuance and prolongation of a sheet or certificate of temporary incapacity for work, and in case of permanent disability (condition after myocardial infarction, aorto-coronary bypass surgery, congestive heart failure) | significant |
149 | Availability of supporting documentation on treatment and diagnostic measures, drug provision, organization of therapeutic nutrition and appropriate care of the patient from the moment of admission to the health care organization. | significant |
150 | Availability of supporting documentation on the use of opportunities for consultation with specialized republican organizations, via telemedicine network in case of difficulty in verifying the diagnosis of the child, determining the tactics of management. If necessary, the child shall be transferred to specialized republican organizations. | significant |
151 | Provision of supportive care (support adequate feeding, maintenance of water balance, pain control, fever management, oxygen therapy) | significant |
152 |
Availability of medical documentation on the provision of the following treatment and diagnostic measures within the framework of primary health care: | significant |
153 | Availability of supporting documentation on the use of less painful, equally effective alternative treatments when available, to avoid unnecessarily painful procedures | significant |
154 |
Availability of documentation on compliance with the requirements of anesthesiology and resuscitation care: | significant |
155 |
Compliance with the following actions when conducting post-mortem examination: | gross |
156 | Availability of a written application of the spouse, close relatives or legal representatives of the deceased or a written will issued by the person during his/her lifetime to release the corpse without post-mortem examination, if there is no suspicion of death through violence | significant |
157 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical briefs) of the clinical audit by Patient Support Services and internal expertise and its evaluation according to the following criteria: | significant |
158 | The patient has been examined by a doctor in the emergency room of an inpatient hospital with the completion of an inpatient card, if the patient or his/her legal representative has given written consent to the provision of medical care to the patient | significant |
159 | Provision by a cardiologist (cardiac surgeon) of a consultative-diagnostic report in the form № 075/y, indicating the results of the conducted examination and treatment, as well as the further treatment of the patient with medical diseases to the primary care physician who referred the patient for consultative services when providing consultative diagnostic assistance | significant |
160 | In the presence of abnormalities in blood pressure (crisis course), arrhythmias of various genesis, increased frequency of angina attacks and increasing symptoms of heart failure, the cardiologist of the Ministry of Health issues and extends a sheet or certificate of temporary disability, and in case of persistent disability (condition after myocardial infarction, aorto-coronary bypass surgery, congestive heart failure) gives an opinion on drawing up documents for referral for medical and social expert assessment (hereinafter referred to as the MSA) | significant |
161 | Availability of documentation on emergency hospitalization of a patient with circulatory diseases to the intensive care unit (ward), bypassing the emergency room in case of life-threatening diseases | significant |
162 | Availability of documentation on hospitalization of a patient diagnosed with acute coronary syndrome (hereinafter - ACS) with segment elevation, acute myocardial infarction (hereinafter - AMI) to the catheterization laboratory, bypassing the admission department, intensive care unit (ward). | significant |
163 |
Availability of documentation on the provision of cardiologic (cardiac surgery) care in inpatient settings, which includes: | significant |
164 | Availability of documentation on the immediate transfer of a patient undergoing treatment in the MO without the possibility of IV therapy when indications for urgent interventional or cardiac surgery are identified, by ambulance, including medical aviation to the MO with the possibility of IV therapy in a 24-hour mode. | significant |
165 |
Availability of supporting documentation on the performance of surgical interventions in cardiac surgery according to the principle of regionalization with regard to the level of complexity: | significant |
Requirements for subjects (objects), providing the hemodialysis care | ||
166 | Availability of written voluntary consent of the patient or his/her legal representative in case of invasive interventions and therapeutic and diagnostic activities | significant |
167 | Availability of a conclusion on the compliance of a healthcare entity to provide high-tech medical services | gross |
168 | Availability of supporting documentation on compliance of treatment and diagnostic measures with the recommendations of clinical protocols | significant |
169 |
Availability of supporting documentation of eligibility for selection and initiation of renal replacement therapy, specifically: | gross |
170 |
Availability of supporting documentation of compliance with the indication for emergency extrarenal blood purification in patients with acute renal failure: | gross |
171 | Availability of supporting documentation that the hemodialysis machine complies with quality certificates, with sufficient life and capacity as stipulated by the country of manufacture | gross |
172 |
Availability of supporting documentation on compliance with the algorithm of hemodialysis procedure: | gross |
173 | Availability of supporting documentation on the provision of drugs and supplies according to the dialysis protocol | significant |
174 | Availability of water treatment system and compliance with requirements for hemodialysis fluid preparation, quality of hemodialysis solutions and blood purification system | significant |
175 | Availability of an agreement for provision of paid medical services in health care organizations. Availability of documents establishing the fact of co-payment | gross |
176 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical briefs) of the clinical audit by Patient Support Services and internal expertise and its evaluation according to the following criteria: | significant |
177 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | Gross |
178 | Availability of supporting documentation on record keeping and accounting records | minor |
Requirements for subjects (objects), providing dental care | ||
179 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | Gross |
180 |
Availability of supporting documentation on compliance with the following requirements in the organization of dental care: | gross |
181 | Availability of a contract for provision of paid services in health care organizations. | gross |
182 | Availability of medical documentation confirming compliance with clinical and diagnostic tests by level of dental care provision | significant |
183 | Availability of form № 058/y “Medical card of a dental patient (including sanitation)” per each patient | minor |
184 | Availability of supporting documentation on compliance of treatment and diagnostic measures with the recommendations of clinical protocols. In the absence of clinical protocols, according to international standards and guidelines based on evidence-based medicine. | significant |
185 | Availability of supporting documentation on record-keeping by specialized professionals working in health care organizations providing dental care | significant |
186 | Availability of completed documentation with information on the provision of dental care (electronic medical records, accompanying materials on the patient's health status and diagnosis), including in the MIS for each tooth in the chart of examination of primary teeth and the chart of examination of permanent teeth | significant |
187 | Availability of documentation on determining the patient's allergy history before dental interventions requiring local (local) anesthesia and, if indicated, referral of the patient to primary health care organizations or medical organizations for laboratory testing to identify drug allergies | gross |
188 |
Availability of supporting documentation on the provision of dental care to children in outpatient settings in the form of consultative and diagnostic assistance by referral and self-referral, includes: | significant |
189 | Availability of an informed consent of parents or representatives in case of dental interventions for children associated with the risk of painful sensations, manipulations are carried out according to the indications with the use of anesthesia (local, sedation, general) | significant |
190 |
Availability of supporting documentation for the provision of dental care to adults in outpatient settings in the form of consultative and diagnostic care by self-referral and referral, which includes: | significant |
191 | Availability of supporting documentation on the provision of dental care in inpatient settings by oral and maxillofacial surgeons and includes prevention, diagnosis, treatment of diseases and conditions requiring the use of special medical methods and technologies, as well as medical rehabilitation | significant |
192 | Availability of supporting documentation on the conduct of a concilium or the use of remote medical services in the differential diagnosis of complex, unclear cases to verify the diagnosis | significant |
193 | Children aged from 0 to 17 years inclusive and pregnant women are subject to dynamic observation and dental examinations | significant |
194 | Availability of supporting documentation on the provision of preventive measures for pregnant women and adults, which include control over the hygienic condition of the oral cavity, instruction on brushing teeth, selection of means and items of oral hygiene, professional oral hygiene, sanitation of the oral cavity (with the use of modern materials and technologies), informational and explanatory work on risk factors for dental diseases, conducted along the route of the primary preventive examination of pregnant women and adults | significant |
195 |
Compliance with the following requirements in the organization and conduct of the medical consultative board: | significant |
196 |
Availability of medical documentation on compliance with the following requirements for the examination of temporary incapacity for work, issuance of a sheet and certificate of temporary incapacity for work (Form № 001/y “Medical Card of Inpatient”, form 052/y “Medical Card of Outpatient”, stubs of sheets on temporary incapacity of patients, form № 025/y “Register for Recording Conclusions of Medical Consultative Board”, form № 029/y "Book of Registration of certificates of temporary incapacity for work”, form № 037/y “Certificate №__________ on temporary incapacity of a student, college or vocational school pupil, sickness, quarantine and other reasons for absence of a child attending school or pre-school organization (underline as necessary)", form № 038/y "Certificate №______ on temporary incapacity" etc.): | significant |
197 | Availability of written voluntary consent of the patient or his/her legal representative in case of invasive interventions and therapeutic and diagnostic activities | significant |
198 |
Availability of supporting documentation on compliance with the requirements of anesthesiology and resuscitation care: | significant |
199 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical briefs) of the clinical audit by Patient Support Services and internal expertise and its evaluation according to the following criteria: | significant |
Requirements for persons/entities (facilities) rendering phthisiatric care | ||
Provision of anti-tuberculosis care at the outpatient and polyclinic level | ||
200 | Presence of supporting documentation on rendering medical care included in the guaranteed volume of free medical care and (or) the system of mandatory social health insurance on a free of charge basis | Gross violation |
201 |
There is supporting documentation that PHC practitioners have undertaken the following activities: | Gross violation |
202 | Existence of supporting documentation on patient screening for suspected tuberculosis in health facilities delivering primary health care under the scheme | Gross violation |
203 | Presence of supporting documentation on the detection of tuberculosis by fluorography among the target population: those at high risk of the disease and subject to mandatory annual fluorography screening | Major violation |
204 | Existence of supporting documentation on the arrangement of directly observed treatment rooms (hereinafter referred to as “DOT”) in primary health care facilities to provide outpatient treatment. The patient shall receive and takes medicine in the DOT room under the supervision of the responsible health care provider. Once every 10 days, patients on directly supervised treatment shall be examined by a primary care physician/phthisiologist of the outpatient clinic, more frequently if specified. Patients residing in rural areas shall be seen by a phthisiatrician once a month | Major violation |
205 |
Evaluation of the clinical condition of a patient receiving anti-tuberculosis treatment for the presence of adverse reactions and events shall be made daily by the attending physician or phthisiatrician, a health care provider of the directly observed treatment room. A health care provider who has revealed adverse reactions and events to a medicinal product shall fill in a report card and make an entry in the patient's medical records. | Gross violation |
206 | Presence of records of anti-tuberculosis medicines movement at the outpatient level in the ATP logbook | Major violation |
207 | Interviewing the patient (parents or guardians of children) prior to treatment about the need for a full course of chemotherapy, followed by signing an informed consent form | Major violation |
208 | Presence of supporting documentation on registration and dispensary monitoring of tuberculosis patients shall be performed in PHC facilities at the place of actual residence, work, study or military service, irrespective of residence registration | Major violation |
209 |
Presence of supporting documentation on compliance with the following requirements in the organisation and conduct of the medical advisory board: | Major violation |
210 |
Existence of supporting documentation on the appropriateness of the levels of medical rehabilitation rendered to patients: | Major violation |
Delivering tuberculosis care at the inpatient level | ||
211 | Existence of supporting documentation on rendering health care included in the guaranteed volume of free medical care and (or) the system of mandatory social health insurance on a free-of-charge basis | Gross violation |
212 |
Assignment of patients to wards based on laboratory data and drug sensitivity at the time of admission and during treatment. | Major violation |
213 |
Presence of daily examination by a physician-phthisiatrician of inpatients. | Major violation |
214 | Presence of supporting documentation on the organisation of a consilium in complex situations to verify the diagnosis and determine treatment tactics with the participation of specialists at regional and national levels in person or remotely through telemedicine | Gross violation |
215 | Availability of records of anti-tuberculosis medicines movement at the inpatient level in the ATM logbook | Major violation |
216 |
Existence of supporting documentation that the criteria for discharging a tuberculosis patient from hospital have been met: | Major violation |
217 | Presence of written voluntary consent of the patient or his/her legal representative in case of invasive interventions and therapeutic and diagnostic measures | Major violation |
218 | Severe patients shall be examined by the head of the ward on the day of admission and daily thereafter. Patients in a moderately severe condition shall be examined at least once a week. The findings of the patient's examination are recorded in the medical record with recommendations on further tactics of patient management with the obligatory identification of the medical worker making the entries | Major violation |
219 | Having an identified clinical diagnosis jointly with the head of department no later than three calendar days from the day of the hospitalisation of the patient by a health care facility | Major violation |
220 | Consultations or consiliums in case of difficulty in identifying the diagnosis, inefficiency of the current treatment, as well as other indications | Gross violation |
221 | A discharge summary is issued to the patient upon discharge, specifying the full clinical diagnosis, the scope of diagnostic tests, therapeutic measures and recommendations for further follow-up and treatment. Discharge data are entered into the information systems on a day-to-day basis, indicating the actual time of discharge. | Minor violation |
222 |
Existence of supporting documentation of compliance with anaesthetic and resuscitation care: | Major violation |
223 |
Evidence of compliance with transfusion requirements for blood components and in case of complications: | Gross violation |
224 |
Examination of persons on clinical indications for HIV infection when the following diseases, syndromes and symptoms are detected: | Gross violation |
225 |
Presence of medical documentation on observance of the following requirements for the examination of temporary incapacity for work, issuance of temporary incapacity for work and certificates of temporary incapacity for work (Form № 001/y “Medical Record of Inpatient Patient”, Form 052/y “Medical Record of Outpatient Patient”, stubs of temporary incapacity for work sheets of patients, form № 025/y “Log for Recording of Reports of Medical Advisory Board”, form № 029/y “Book of Registration of Sheets on Temporary Disability”, form № 037/y “Certificate №__________ on Temporary Disability of a Student, College Student, Vocational School Student, on Illness, Quarantine and Other Reasons for the Absence of a Child Attending School, Pre-School Institution (underline as appropriate)”, form № 038/y “Certificate №______ on Temporary Disability” and others): | Major violation |
226 |
Existence of documentation (internal orders, regulations, protocols, questionnaires, analytical briefs) of the clinical audit by Patient Support Services and internal expertise and its evaluation based on the following criteria: | Major violation |
227 |
Presence of documentation of adherence to the following when performing pathologic autopsies: | Gross violation |
228 | A written application from the spouse, close relatives or lawful guardians of the deceased or a written will given by the person during his or her lifetime to release the corpse without a pathological anatomical autopsy, if there is no suspicion of violent death | Major violation |
229 | Presence of an agreement for rendering paid medical services by health care providers. Availability of documents establishing the fact of co-payment | Gross violation |
230 |
Existence of supporting documentation on conformity of levels of medical rehabilitation delivery to patients: | Major violation |
231 | A medical worker's entry in the medical record with the subsequent collection of biological materials to determine the content of a psychoactive substance and recording the results in the medical record when signs of psychoactive substance use are detected during a request for medical assistance in a health care facility without issuing a medical examination report to establish the fact of psychoactive substance use and state of intoxication. | Minor violation |
232 | Availability of supporting documentation on consistency of treatment and diagnostic measures with the recommendations of clinical protocols. | Major violation |
Requirements for entities (facilities) rendering oncological care | ||
233 | Existence of supporting documentation on the delivery of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free-of-charge basis | Gross violation |
234 |
Existence of a multidisciplinary team to ensure an individualised approach to the delivery of medical care to patients with malignant neoplasms. | Gross violation |
235 |
Presence of supporting documentation of review at the MDG sessions: | Gross violation |
236 |
Presence of supporting documentation on the organisation by PHC experts of: | Major violation |
237 |
Existence of supporting documentation on the provision of CDC, which includes: | Major violation |
238 |
There is supporting documentation that the GP has referred the patient to an oncologist or cancer care co-ordinator if a tumour disease is diagnosed or suspected. | Major violation |
239 |
Presence of supporting documentation on observance of requirements when rendering oncological care in the form of outpatient and polyclinic care: | Major violation |
240 |
Presence of supporting documentation on immunohistochemical studies and molecular genetic studies to evaluate molecular and biological features of tumours in order to individualise treatment of patients, as well as to confirm (verify) the diagnosis of MN. IHC studies are performed at the level of pathomorphological laboratories of oncological care providers at the secondary level and reference centres at the tertiary level and are performed following clinical protocols. | Major violation |
241 | Presence of confirming documentation of international teleconsultations of tumour biosamples via the telepathology system to clarify the diagnosis in complex clinical cases. The timeframe for teleconsultations does not exceed thirty working days. | Gross violation |
242 |
There is confirmatory documentation that the entire period of examination of patients with suspected MN in outpatient clinics with cancer precautionary markers within the following examination timeframes is reflected in the MIS: | Gross violation |
243 | Presence of supporting documentation that a patient with MN receives specialised treatment no later than thirty calendar days after the diagnosis is established and the patient is placed under dynamic monitoring. | |
244 |
There are supporting documents on dynamic follow-up of clinical groups of patients with suspected MN and confirmed diagnosis of MN: | Major violation |
245 |
Patients with MN are subject to lifelong follow-up in an institution rendering medical care in outpatient conditions at the place of registration - primary level (III clinical group) and institutions rendering oncological care at the secondary level (II clinical group) at the place of residence and registration. | Major violation |
246 | Upon establishing a diagnosis of MN for the first time, a form № 034/y “Notification” is filled out for each patient, which is sent within three working days to the institution rendering oncological care at the secondary level at the place of the patient's permanent residence for registration in the Electronic Register of Oncological Patients and Registration, specifying the circumstances of the diagnosis (patient's self-referral to a primary health care facility, CDC - primary level, patient's self-referral to an institution offering oncological care at secondary and tertiary levels, diagnosis established during screening examination, diagnosis established during preventive examination) | Major violation |
247 |
Each patient with a first-time diagnosis of stage IV MN and visually accessible localisations of stage III disease should have a protocol completed in case a patient is diagnosed with an advanced form of malignant neoplasm (clinical group V). | Gross violation |
248 | Presence of mandatory confidential medical screening for HIV infection of persons based on clinical and epidemiological grounds, including sexual partners of pregnant women, persons who applied voluntarily and anonymously. | Major violation |
249 |
Presence of supporting documentation on observance of indicators for hospitalisation in a day hospital at outpatient and polyclinic health care facilities and inpatient care at home: | Major violation |
250 |
Presence of medical documentation on observance of the following requirements during the examination of temporary incapacity for work, issuance of a sheet and a certificate of temporary incapacity for work (form № 001/y “Medical Records of an Inpatient Patient”, form № 052/y “Medical Records of an Outpatient Patient”, stubs of certificates of temporary incapacity for work of patients, form № 025/y “Log for Recording Opinions of Medical Advisory Board”, form № 029/y “Book of Registration of Certificates of Temporary Incapacity for Work”, form № 037/y “Certificate №__________ on Temporary Disability of a Student, Pupil of a College, Vocational School, Sickness, Quarantine and Other Reasons for Absence of a Child Attending School, Preschool Institution (underline as appropriate)”, form № 038/y “Certificate №______ on Temporary Disability” and others. | Major violation |
251 |
Presence of documentation (internal orders, regulations, protocols, questionnaires, analyses) of the clinical audit by the Patient Support Service and internal expertise and its evaluation against the following criteria: | Major violation |
Delivery of oncological care at the inpatient level | ||
252 | Presence of confirming documentation regarding rendering medical care included in the guaranteed volume of free medical care and (or) the system of mandatory social health insurance on a free-of-charge basis | Gross violation |
253 |
Presence of confirming documentation on dilution of antitumour drugs in the rooms of centralised dilution of cytostatic drugs (hereinafter - RCDC) to ensure safety of medical personnel from toxic effects of antitumour drugs and rational use of drugs. | Major violation |
254 |
Presence of supporting documentation that radiation therapy is performed based on the principle of “single physician - radiation therapist (radiation oncologist)”, providing for clinical management of the patient, pre-radiation preparation and radiation treatment by a single physician - radiation therapist (radiation oncologist). | Major violation |
255 |
Presence of supporting documentation that anti-tumour therapy, radiation and radionuclide therapy, palliative care in cases that do not require constant medical supervision are delivered to patients with MN under inpatient substitution conditions in institutions rendering oncological care at secondary and tertiary levels in chemotherapy, radiation therapy, palliative care, medical rehabilitation wards. | Major violation |
256 | Hospitalisation of a severe patient in need of constant monitoring of vital functions for medical reasons, by decision of a consilium and notification of the heads of health care facilities, followed by transfer to another healthcare facility based on the profile of the disease for further examination and treatment after stabilisation of the condition | Major violation |
257 | Severe patients are examined by the head of the ward on the day of hospitalisation and daily thereafter. Patients in a moderately severe condition are examined at least once a week. The results of the patient's examination are recorded in the medical record with recommendations on further tactics of the patient's management with obligatory identification of the medical worker making the entries | Major violation |
258 | Presence of an established clinical diagnosis jointly with the head of ward no later than three calendar days from the day of the patient's hospitalisation in a health care facility | Major violation |
259 |
Daily examination of patients in the hospital by the attending physician, excluding weekends and public holidays. Upon examination and appointment of additional diagnostic and therapeutic manipulations by the physician on duty, appropriate entries are made in the medical record. If the patient's condition worsens, the physician on duty notifies the head of the ward and (or) the attending physician, agrees to make changes in the process of diagnosis and treatment, and makes an entry in the medical record (paper and (or) electronic) option. | Major violation |
260 | Consultations or consiliums in case of difficulty in identifying the diagnosis, inefficiency of the current treatment, as well as other indications | Gross violation |
261 |
Presence of examination of persons on clinical indications for HIV infection upon detection of the following diseases, syndromes and symptoms: | Gross violation |
262 | Presence of an agreement for rendering paid medical services in health care facilities. Availability of documents establishing the fact of co-payment | Gross violation |
263 |
Presence of confirming documentation that discharge criteria have been met, such as: | Major violation |
264 | Discharge epicrisis is issued to the patient upon discharge, stating the full clinical diagnosis, the scope of diagnostic tests, therapeutic measures and recommendations for further follow-up and treatment. Discharge data are entered into information systems on a day-to-day basis, specifying the actual time of discharge. | Minor violation |
265 |
There is supporting documentation of adherence to the requirements for transfusion of blood components and in case of complications: | Gross violation |
266 |
Presence of supporting documentation on the determination of the method and tactics of treatment by the MDG. | Gross violation |
267 | Presence of confirming documentation on conformity of the provided medical care to clinical protocols | Major violation |
268 |
Presence of medical documentation on observance of the following requirements for the examination of temporary incapacity for work, issuance of certificates of temporary incapacity for work (form № 001/y “Medical Record of Inpatient Patient”, form № 052/y “Medical Record of Outpatient Patient”, stubs of patients' certificates of temporary incapacity for work, form № 025/y “Log for Recording Medical Advisory Board Reports”, form № 029/y “Book of Registration of Certificates of Temporary Incapacity for Work”, Form № 037/y “Certificate №__________ on Temporary Incapacity for Work of a Student, a Student of a College, a Vocational School, on Illness, Quarantine and Other Reasons for the Absence of a Child Attending School, Pre-School Institution (to be underlined)”, Form № 038/y “Certificate №______ on Temporary Incapacity for Work” and others): | Major violation |
269 |
Presence of documentation (internal orders, regulations, protocols, questionnaires, analyses) of the clinical audit by the Patient Support Service and internal expertise and its evaluation against the following criteria: | Major violation |
270 |
Presence of confirming documentation of observance of the following actions when performing pathological autopsies: | Gross violation |
271 | Presence of a written application from the spouse, close relatives or lawful guardians of the deceased or a written will given by the person during his/her lifetime to release the corpse without a pathological anatomical autopsy, in the absence of suspicion of violent death | Major violation |
272 |
Presence of supporting documentation on rendering oncological care at home: | Major violation |
Requirements for persons (facilities) offering medical and social assistance in the field of mental health care | ||
Requirements for actors (facilities) offering medical and social care in the field of mental health at the outpatient and polyclinic level | ||
273 | Presence of supporting documentation on rendering health care included in the guaranteed volume of free medical care and (or) the system of mandatory social health insurance on a free-of-charge basis | Gross violation |
274 |
Presence of confirming documentation on observance of the criteria for dynamic observation of persons with MBD: | Major violation |
275 |
Presence of confirming documentation on observance of the requirement to supply medicines to persons with MBD under dynamic monitoring | Major violation |
276 |
Presence of confirming documentation of adherence to the requirements for deregistration and transfer to another group of dynamic monitoring: | Major violation |
277 |
Presence of confirming documentation on the implementation of the following activities during dynamic monitoring of a person with MBD by a psychiatric doctor: | Major violation |
278 |
Presence of an individual treatment plan and rehabilitation programme for persons after discharge from a facility rendering health care in the field of mental health, excluding those discharged by court order as early recovered. | Major violation |
279 |
Presence of confirming documentation of the implementation of PHC by a physician, upon suspicion or identification of a person with a MBD, excluding MBD requiring emergency and urgent medical and social care: | Major violation |
280 |
Implementation of the following activities by a mental health clinician of a MHU or PMHC when a person with PPR is suspected or identified, excluding MBD requiring emergency and urgent medical and social care: | Major violation |
281 |
There is confirming documentation regarding the implementation of the following activities by the psychiatric physician of the MHU or PMHC when a person who was previously on dynamic follow-up with a MBD applies and is deregistered from the EIS with a reason for deregistration other than “convalescence, persistent improvement”: | Major violation |
282 |
Presence of documentation (internal orders, regulations, protocols, questionnaires, analyses) of the clinical audit by the Patient Support Service and internal expertise and its evaluation against the following criteria: | Major violation |
Requirements for entities (facilities) delivering health and social care in the field of mental health in inpatient settings with 24-hour medical supervision | ||
283 | Presence of confirming documentation on rendering medical care included in the guaranteed volume of free medical care and (or) the system of mandatory social health insurance on a free of charge basis | Gross violation |
284 |
There are grounds for hospitalisation in inpatient clinical units. | Major violation |
285 |
Comprehensiveness of the measures implemented during planned hospitalisation in inpatient clinical wards of RSPCMH, MHC. | Major violation |
286 |
Comprehensiveness of the measures undertaken during hospitalisation in the inpatient clinical ward of RSPCMH, MHC for emergency indications. | Major violation |
287 |
Comprehensiveness of the activities undertaken during routine hospitalisation in PFSIS. | Major violation |
288 |
Comprehensiveness of the activities undertaken after admission of a person with MBD to the inpatient clinical unit. | Major violation |
289 |
Comprehensiveness of interventions following the person's admission to the PFSIS inpatient clinical unit | Major violation |
290 |
Adherence to observation regimes. | Major violation |
291 |
Presence of confirming documentation that the criteria for forced hospitalisation in an inpatient hospital have been met: | Major violation |
292 |
There is confirming documentation that the conditions of discharge have been met. | Major violation |
293 |
Presence of documentation (internal orders, regulations, protocols, questionnaires, analyses) of the clinical audit by the Patient Support Service and internal expertise and its evaluation against the following criteria: | Major violation |
Requirements for entities (facilities) delivering health and social care in the field of mental health in inpatient substitute conditions that do not require 24-hour medical supervision and treatment and include medical supervision and treatment during the day with the provision of a bed place | ||
294 | Presence of confirming documentation on the delivery of medical care included in the guaranteed volume of free medical care and (or) the system of mandatory social health insurance on a free-of-charge basis | Gross violation |
295 |
Indications for inpatient substitution treatment for persons with MBD | Major violation |
296 |
Implementation of the following activities during day hospitalisation: | Major violation |
297 |
Requirements for the duration of treatment and time of stay in the day hospital. | Major violation |
298 |
Observing the requirements for discharge from the day care hospital. | Major violation |
299 |
Presence of documentation (internal orders, regulations, protocols, questionnaires, analyses) of the clinical audit by the Patient Support Service and internal expertise and its evaluation against the following criteria: | Major violation |
Requirements for entities (facilities) delivering health and social care to persons with mental, behavioural disorders (diseases) in the form of emergency health and social care | ||
300 | Emergency specialised psychiatric care is rendered by specialised teams organised as part of the organisation delivering emergency health and social care or MHC. | Major violation |
Requirements for actors(facilities) offering health and social rehabilitation in the field of mental health | ||
301 | Presence of confirming documentation on the delivery of health care included in the guaranteed volume of free medical care and (or) the system of mandatory social health insurance on a free-of-charge basis | Gross violation |
302 |
Presence of confirming documentation on fulfilment of the requirements for health and social rehabilitation in outpatient or inpatient substitute conditions. | Major violation |
303 |
Presence of confirming documentation on adherence to the requirements for medical and social rehabilitation in inpatient settings. | Major violation |
304 |
Presence of proving documentation on the implementation of the activities of the multidisciplinary group. | Gross violation |
305 |
Requirements for the duration of medical and social rehabilitation. | Major violation |
Requirements for entities (facilities) rendering health examinations to establish the fact of psychoactive substance use and intoxication status | ||
306 | Presence of confirming documentation on the delivery of healthcare included in the guaranteed volume of free medical care and (or) the system of mandatory social health insurance on a free-of-charge basis | Gross violation |
307 |
Presence of confirmatory documentation on observance of the requirements for identification of the person referred or coming for health examination. | Major violation |
308 |
Presence of confirming documentation on observance of the requirements for performing the examination of foreign citizens and underage citizens of the Republic of Kazakhstan. Foreign citizens permanently residing and temporarily staying on the territory of the Republic of Kazakhstan, as well as stateless persons who are intoxicated in a public place, at work, or driving a vehicle, should undergo physical examination on general grounds. | Major violation |
309 |
Presence of supporting documentation on observance of the requirements for health examination of persons brought in in a seriously unconscious state. | Major violation |
310 |
Presence of confirming documentation on observance of the requirements to the conditions for laboratory examination or rapid testing of biological media. | Major violation |
311 |
Presence of confirming documentation on observance of the requirements for laboratory examination or rapid testing of biological media. | Major violation |
312 |
Presence of confirming documentation on observance of the requirements for the quantitative breath alcohol test. | Major violation |
313 |
Presence of confirming documentation of fulfilment of the requirements for issuing a refusal of health examination | Major violation |
314 |
Presence of confirmatory documentation on observance of the requirements for establishing the condition of the person being examined. | Major violation |
315 |
Presence of supporting documentation on adherence to the requirements for drawing up the Report of Medical Examination. | Major violation |
316 |
Presence of confirming documentation on observance of the requirements for repeated medical examination. | Major violation |
Requirements for actors (facilities) offering temporary adaptation and detoxification services | ||
317 | Presence of confirming documentation on the delivery of medical care included in the guaranteed volume of free medical care and (or) the system of mandatory social health insurance on a free-of-charge basis | Gross violation |
318 |
There is confirming documentation on observance of the requirements for the operation of the temporary adaptation and detoxification centre: | Major violation |
319 |
Establishing the identity of the delivered person by the internal affairs officers and reporting it to the health care personnel of the TADC. | Major violation |
320 |
Registration of a person delivered with suspected alcohol intoxication in the logbook of admissions and refusals of hospitalisation in the approved form | Major violation |
321 |
The findings of the medical examination are recorded in a report on the medical examination conducted at the TADC (hereinafter - the report) as per the approved form | Major violation |
322 |
Registration of personal belongings, documents, money and other valuables by health care personnel in the patient's document and personal belongings registration log pursuant to the form prior to the patient's admission to the TADC. | Major violation |
323 | Availability of the record of the patient placed in the TADC (hereinafter referred to as the patient's record) If there are medical indications, treatment is prescribed. The doctor's prescriptions are recorded in the patient's card. The frequency of medical examinations depends on the patient's condition. | Major violation |
324 | The patient is discharged by a psychiatrist (narcologist) on a planned basis if the patient's condition has improved and does not require further observation and treatment at the TADC within twenty-four (24) hours of admission. When the patient is discharged, a relevant entry is made in the patient's card and in the log of admissions and refusals to hospitalisation. | Major violation |
325 | Written confirmation from the patient that upon receipt of his/her documents and personal belongings, all documents and personal belongings have been received as recorded in the log book of patients' documents and personal belongings, excluding items that are illegal to keep. | Major violation |
Requirements for actors (facilities) offering medical examinations and sex reassignment for persons with gender identity disorder | ||
326 | Presence of confirming documentation on the delivery of healthcare included in the guaranteed volume of free medical care and (or) the system of mandatory social health insurance on a free-of-charge basis | Gross violation |
327 |
Presence of confirming documentation on observance of the requirement for medical examination of persons with gender identity disorder for sex reassignment: | Major violation |
328 | Referral by a psychiatrist of the person being examined, if there are doubts about his or her mental state, to a healthcare facility for an inpatient examination | Major violation |
329 |
Referral of the person to be examined by a psychiatrist, in the absence of MBD, being contraindications for sex reassignment, to the polyclinic at the place of residence, for medical examination | Major violation |
Requirements for entities (facilities) providing laboratory services | ||
330 | Presence of supporting documentation on the delivery of medical care included in the guaranteed volume of free medical care and (or) the system of mandatory social health insurance on a free-of-charge basis | Gross violation |
331 | Presence of written voluntary consent of the patient or his/her lawful guardian for invasive interventions and therapeutic and diagnostic measures | Major violation |
332 | The presence of a biosafety expert in the laboratory staff (if the laboratory staff is more than twenty full-time units) | Major violation |
333 | Availability of portable test strip analysers in primary health care facilities | Major violation |
334 |
Presence at the inpatient level in health care facilities as part of the consultative and diagnostic laboratory (hereinafter - CDL) of an additional unit or a separate express-laboratory in intensive care units to perform emergency and urgent laboratory tests within a minimum time from sample collection to reporting the result (within 15-60 minutes). | Major violation |
335 | Running quality management processes for clinical laboratory tests based on the principle of staging, which includes the pre-analytical, analytical and post-analytical stages of a laboratory test | Major violation |
336 | Use of equipment, diagnostic reagent kits, test systems and complete consumables certified and registered in the Republic of Kazakhstan to perform tests | Major violation |
337 | Availability of laboratory information system | Major violation |
338 | Conducting intra-laboratory quality control of the tests | Major violation |
339 | Observance of triple packaging and temperature regime when transporting biomaterial, including by road, air and railway transport. | Major violation |
340 | Presence of supporting documentation of observance of the algorithm of analytical quality control in laboratory diagnostics | Major violation |
341 | Presence of an agreement for rendering paid medical services in health care facilities. Presence of documents establishing the fact of co-payment | Gross violation |
342 | Availability of supporting documentation on the competence and quality of laboratory diagnostics | Major violation |
343 | Documenting the performance of laboratory diagnostics | Major violation |
Requirements for entities (facilities) delivering emergency medical aid and medical aid in the form of medical aviation | ||
General requirements | ||
344 | Presence of confirming documentation on the delivery of medical care included in the guaranteed volume of free medical care and (or) the system of mandatory social health insurance on a free-of-charge basis | Gross violation |
345 | Presence of supporting documentation on conformity of treatment and diagnostic measures with the recommendations of clinical protocols | Major violation |
346 |
Presence of documentation (internal orders, regulations, protocols, questionnaires, analytical reports) on clinical audit by the Patient Support Service and internal expertise and its evaluation against the following criteria: | Major violation |
For emergency ambulance service | ||
347 | Equipping sanitation vehicles with radio communication and navigation system | Gross violation |
348 | Availability in the ambulance service of regions, cities of national importance and the capital city of an automated control system for receiving and processing calls and systems enabling monitoring of ambulance vehicles by means of navigation systems, as well as a system of computer recording of dialogues with subscribers and an automatic identifier of the telephone number from which the call is received. Dialogue recordings are stored for at least 2 years. | Gross violation |
349 | Presence of regional call-centres (call-centres) within regional emergency medical aid stations and emergency medical aid stations of cities of national importance and the capital city | Gross violation |
350 | Observance of a five-minute processing time of an ambulance call from the moment it is received by the dispatcher, during which time the call is triaged by urgency category. | Major violation |
351 | Adherence to the time of arrival of the brigade to the patient's location from the moment of receiving the call from the dispatcher as per the list of urgency categories of emergency medical calls (from 10 minutes to 60 minutes) | Major violation |
352 |
The dispatcher of the emergency health care service (EHCS) correctly identifies calls by urgency category as per: | Major violation |
353 |
A paramedic or a physician of an EMS or team makes one of the following decisions when organising primary health care, based on the results of examination data, instrumental diagnostics, patient's condition dynamics against the background of or after treatment measures, in line with the preliminary diagnosis reflecting the causes of the condition: | Gross violation |
354 | Medical recommendations are offered for further referral to a primary health care facility (at the place of residence or registration in case a patient who does not need hospitalisation is left at the place of call or at home, by a team from an EMC or an EHCS unit at a primary health care facility) | Major violation |
355 | Presence of a patient signalling sheet in case a patient is ill and needs a home visit by a precinct physician | Major violation |
356 |
Availability of recording of the following data when a call is received by the dispatch service of the ambulance station: | Major violation |
357 |
Observance of the time of arrival of paramedic and specialised (medical) teams to the patient's location from the moment of receiving a call from the dispatcher of the ambulance station, with due regard to the category of urgency: | Major violation |
358 | The dispatcher of the EHCS is informed of the patient's delivery in case a decision is made by the team of the EMC or the EHCS department to transport the patient to the hospital. | Major violation |
359 | Availability of a minimum list of medical devices for ambulance station transport by classes A, B and C | Major violation |
For medical assistance in the form of medical aviation | ||
360 | Presence of an assignment for sanitary flight as per form № 090/y | Major violation |
361 | Supporting documentation that the mobile medical aviation team, while transporting the patient(s), routinely evaluates and treats the patient(s) following appropriate clinical protocols for diagnosis and treatment. | Major violation |
362 | Presence of grounds for granting medical assistance in the form of medical aviation ( an excerpt from the medical record of a patient in need of medical assistance in the form of medical aviation; a request from the coordinating physician of the medical aviation department to the dispatcher of the Coordinating Entity; in emergency cases, a verbal order from a competent authority with written confirmation; a call from the emergency medical services and other emergency services) | Gross violation |
363 | Dispatcher of the Coordinating Entity has agreed on the membership of the mobile medical aviation brigade and the involved qualified specialist(s) from the regional healthcare facilities with their informed consent. | Major violation |
364 | Presence in the Coordinating Entity of a schedule of qualified specialists for medical assistance in the form of medical aviation approved by health care entities and medical education institutions | Gross violation |
365 |
Presence of informed consent of the patient (s) for medical assistance in the form of medical aviation during his/her transportation. | Gross violation |
Requirements for actors (facilities) engaged in HIV prevention activities | ||
366 | Availability of supporting documentation on the delivery of healthcare included in the guaranteed volume of free medical care and (or) the system of mandatory social health insurance on a free-of-charge basis | Gross violation |
367 |
Examination by express testing method with registration in the register of HIV tests by express testing method. | Major violation |
368 | Availability of written notification by the health care facility, which revealed during medical examination the fact of HIV infection in the examined person of the result obtained, of the necessity to observe precautionary measures aimed at protecting one's own health and the health of others, as well as warning of administrative and criminal liability for evasion from treatment and infection of other persons, with the patient signing a confidential interview sheet with a person infected with HIV as per form № 095/y | Major violation |
369 |
Presence of supporting documentation on adherence to the deadlines for issuing negative results. | Major violation |
370 |
Presence of supporting documentation on adherence to the deadlines for sending serum samples to the RSHF. | Major violation |
371 |
Presence of supporting documentation of fulfilment of re-examination deadlines in case of doubtful results. | Major violation |
372 |
Pre-test and post-test counselling is available. | Major violation |
373 | Health care facility engaged in HIV prevention activities sends an emergency notification in form № 034/y to the territorial public authority in the field of sanitary and epidemiological well-being for each case of HIV infection presumably related to the delivery of medical care (intra-hospital one) | Gross violation |
374 | Presence of the Confidential Interview Sheet with a person infected with HIV, Form № 095/y, that includes: his/her consent to enter personal data into electronic information resources. In case of refusal to enter personal data into the ES system, data is entered, specifying immune blocking number (hereinafter - IB), date of IB, initials, date of birth, data of epidemiological anamnesis | Major violation |
375 | Monitoring and evaluation of the coverage of key populations and people living with HIV infection is performed by maintaining a database of individual client records and relevant forms of accounting and reporting documentation by experts from health care facilities involved in HIV prevention activities | Major violation |
376 | Transfer by the health care workers diagnosed with HIV-infection to another job that does not involve violation of the integrity of skin or mucous membranes. | Gross violation |
377 |
Availability of supporting documentation on the diagnosis and treatment of STIs. | Major violation |
378 | Availability of equipped transport for mobile confidence-building centres | Major violation |
379 | Availability of confirmatory documentation of implementation of pre-exposure and post-exposure prophylaxis in the population and key populations | Major violation |
380 |
Surveillance of contact persons within the established timeframes. | Gross violation |
381 |
Dynamic monitoring and ensuring antiretroviral therapy of HIV-infected persons. | Gross violation |
382 |
Presence of documentation (internal orders, regulations, protocols, questionnaires, analyses) of the clinical audit by the Patient Support Service and internal expertise and its evaluation against the following criteria: | Major violation |
Requirements for actors (facilities) engaged in activities in the field of blood services | ||
383 | Presence of supporting documentation on the delivery of medical care included in the guaranteed volume of free medical care and (or) the system of mandatory social health insurance on a free-of-charge basis | Gross violation |
384 | Evidence of adherence by the blood service institution to the requirements for the stepwise labelling of blood and blood components. Ensuring the traceability of each blood product from the donor to the finished product and its use | Gross violation |
385 | Presence of supporting documentation on meeting the requirements for laboratory testing of recipient blood samples for the presence of markers of haemotransmissible infections before and after transfusion by qualitative immunoserological and molecular-biological methods on automatic closed-type analysers. | Gross violation |
386 | Registration in the electronic information database after donation of blood and its components of all data on donation of blood and its components, including the type of reaction and the amount of medical care provided, in case of side effects of donation, correspondence of documents on transfer to the primary fractionation unit with the accompanying documentation of the collected blood and its components | Major violation |
387 | Availability of a blood and blood component donor questionnaire and an information sheet given to the donor, which he/she fills in independently or with the participation of a medical registrar | Major violation |
388 | Presence of confirmatory documentation of adherence to the requirements for performing immunohaematology studies for irregular anti-erythrocyte antibodies in liquid-phase systems on plane and in vitro, reading the result of agglutination reaction with obligatory microscopy. | Major violation |
389 |
Presence of confirming documentation of adherence to the requirements for incoming and daily in-laboratory quality control of reagents to confirm their activity and specificity. Input control includes: | Major violation |
390 | Placement of blood collected in travelling conditions in thermocontainers labelled “Untested Haemoproducts, not to be Handed Out” and delivered at 22±2°C for 18-24 hours to the blood service centre. | Major violation |
391 | Use of reagents with monoclonal antibodies and equipment registered by the public authority in the sphere of circulation of medicines and medical devices for immunohaematological studies of blood samples of potential recipients | Major violation |
392 | Presence of supporting documentation on fulfilment of requirements for transfusion of blood, its components | Major violation |
393 | Presence of supporting documentation on observance of the requirements of compulsory medical examination of the donor before donation of blood and its components within the framework of the guaranteed volume of free medical care | Major violation |
394 | Consistency with donor medical clearance, safety and quality requirements in the manufacture of blood products for medical use | Major violation |
395 | Presence of confirming documentation on observing the requirements of external quality evaluation of measurement quality of laboratory tests in reference laboratories | Major violation |
396 | Adherence to incoming and daily in-laboratory quality control of reagents to confirm reagent activity, and specificity. | Major violation |
397 | Presence of a blood and blood components donor questionnaire available to the donor, which he/she fills in on his/her own or with the assistance of a medical registrar. | Major violation |
398 |
The following are subject to input control: | Major violation |
399 | Conformity with donor medical clearance, safety and quality requirements in the manufacture of blood products for medical use | Major violation |
400 |
Presence of documentation (internal orders, regulations, protocols, questionnaires, analyses) of the clinical audit by the Patient Support Service and internal expertise and its evaluation against the following criteria: | Major violation |
Requirements for entities (facilities) performing pathological anatomical diagnostics | ||
401 | Presence of supporting documentation on the delivery of medical care included in the guaranteed volume of free medical care and (or) the system of mandatory social health insurance on a free-of-charge basis | Gross violation |
402 | Observance of the requirement to register the refusal to accept biological material, stapled with a copy of the referral for analysis of biological material in the pathology unit in a separate folder (“Rejected Samples”), as well as in a separate log (“Rejected Samples”). | Major violation |
403 | Adherence by the pathologist to the requirement for participation of the laboratory technician in the work on based on the act of excision, macroscopic examination and macroscopic description of the biological material. The medical specialist who sent the material for examination is involved when additional clinical information is required at the stage of macroscopic examination of the biological material | Major violation |
404 | Observance of the requirement that tissue fragments have a thickness of 5 millimetres (hereinafter - mm) and an average diameter of no more than 24 mm. | Major violation |
405 | Presence of microscopic description in the protocol of pathological and anatomical examination of biopsy (surgical) and autopsy material | Major violation |
406 | Adherence to the requirement to issue the results of pathomorphological examination with entries in the established form logs by the medical registrar or laboratory technician | Major violation |
407 | Presence of supporting documentation on meeting the requirement to store tissue samples in paraffin blocks in a single archive organised by the principle of end-to-end numbering | Major violation |
408 | Presence of supporting documentation on meeting the requirement to store tissue specimens in paraffin blocks in a specially equipped dry and cool room, using specialised archiving systems and adapted containers, as well as storage of microdrugs in specialised archiving systems. | Gross violation |
409 | Adherence to the requirement to place micro specimens in boxes in such a way that slides pertaining to one case are arranged in one indivisible unit | Major violation |
410 | Observance of the requirement for the laboratory technician to sort and prepare biological and medical waste for disposal | Major violation |
411 | Presence of written consent of the spouse or one of the close relatives or lawful guardians in case of pathological and anatomical diagnosis in case of unspecified immediate cause of death | Major violation |
412 | Adherence to the requirement for an independent (independent) expert(s) to perform a pathological anatomical autopsy of the deceased at the request of the spouse, close relatives or legal representative | Major violation |
413 | Adherence to the requirement to issue a medical certificate of death (preliminary, final) on the day of the pathological anatomical autopsy by a physician specialising in pathological anatomy (adult, paediatric) | Major violation |
414 | Adherence to the requirement to document autopsy results in the form of a pathological examination report | Major violation |
415 | Observance of the requirement to stop the autopsy when signs of violent death are detected during the pathological anatomical examination of the corpse, the head of the healthcare facility reports the incident in writing to the forensic and investigative authorities to address the issue of transferring the corpse for forensic medical examination. A physician specialising in pathological anatomy (adult, paediatric) undertakes measures to preserve the body, organs and tissues of the corpse for further forensic medical examination. A protocol is prepared for the performed part of the pathological anatomical examination, at the end of which the reason for further forensic medical examination is indicated. In each case of interrupted pathological autopsy, the pathologist informs in writing the head of the ward, the administration of the health care facility where the death occurred immediately after the interruption of the autopsy | Major violation |
416 | Observance of the requirement to send an emergency notification to the public authority in the sphere of sanitary and epidemiological well-being of the population by a physician specialising in “Pathological Anatomy (for Adults, for Children)” in case of initial detection during autopsy of signs of acute infectious disease, food or industrial poisoning, unusual reaction to vaccination | Major violation |
417 | Observance of the requirement for pathological and anatomical autopsy of all newborn children who died in healthcare facilities, including obstetric facilities (regardless of how long after birth they showed signs of life) and stillborn foetuses with a body weight of 500 grams or more at a gestational age of 22 weeks or more, including after termination of pregnancy (spontaneous, for medical and social reasons) with mandatory histological examination of the placenta and registration of a medical certificate of perinatal care. | Major violation |
418 | Observance of the requirement of the head of the pathological anatomy department to ensure that autopsies are performed on dead newborns and stillborns with mandatory histological examination of tissue and organ fragments and inclusion in the protocol of pathological anatomical examination. | Major violation |
419 | Adherence to the requirement by the heads of health care facilities and heads of pathological anatomical units of the facility for the required virological and bacteriological examination of autopsy materials of deceased newborns, stillborns and placentas, using appropriate laboratories of health care facilities or public authorities and agencies in the field of sanitary and epidemiological well-being of the population. | Major violation |
420 | Adherence to the requirement to issue a medical certificate of perinatal death (preliminary, final, instead of preliminary) by a physician specialising in pathological anatomy (adult, paediatric) on the day of the pathological anatomical autopsy. | Major violation |
421 |
Adherence to the requirement by a physician specialising in “Pathological Anatomy (for Adults, for Children)” when drawing up a pathological anatomical diagnosis based on the results of a pathological anatomical autopsy: | Major violation |
422 | Observance of the requirements for registration and maintenance of primary medical documentation | Major violation |
423 |
Presence of supporting documentation on observance of the requirement for accounting of pathological anatomical examination materials (biopsy, surgical and autopsy material): | Major violation |
424 |
Observance of the requirement not to submit the protocol of pathological anatomical examination to the spouse, close relatives, legal representatives or other persons for familiarisation. | Major violation |
425 | Adherence to the requirement to issue originals or copies of pathological anatomical examination reports at the request of bodies of enquiry and preliminary examination, prosecutor, lawyer and (or) court due to investigation or court proceedings, as well as at the request of public authorities in the field of medical services (aid) | Major violation |
426 |
Observance of requirements for cytological examinations, which include: | Major violation |
427 | Presence of supporting documentation on meeting the requirement for the laboratory technician's acceptance, initial sorting and registration of biological material received in the cytology laboratory, macroscopic examination, description of biological material, processing of biological material (preparation, fixation, staining, conclusion, sorting of cytological microdrugs). | Major violation |
428 | There is documentation of adherence to the requirement to perform microscopic examination in the first step by a laboratory technician, then by a cytologist | Major violation |
429 | Observance of the requirement to involve a physician ( relevant expert) when it is required to obtain additional clinical information at the stage of microscopic examination of biological material, who sent the material for examination. The final microscopic examination of smears and drawing up a protocol of the results of the study is performed by a cytologist | Major violation |
430 | Adherence to the requirement to establish the category of pathological anatomy (adult, paediatric) by a physician specialising in pathological anatomy (adult, paediatric) and the reason for the discrepancy between the final clinical and pathological diagnoses | Gross violation |
Requirements for entities (facilities) assisting in the field of nuclear medicine | ||
431 | Presence of supporting documentation on the delivery of medical care included in the guaranteed volume of free medical care and (or) the system of mandatory social health insurance on a free-of-charge basis | Gross violation |
432 | Presence of supporting documentation on conformity of treatment and diagnostic measures with the recommendations of clinical protocols | Major violation |
433 |
Presence of documentation confirming the status of the Nuclear Medicine Centre (hereinafter referred to as the Centre) as a structural unit of a multidisciplinary hospital or an independent healthcare facility rendering medical care to the population of the Republic of Kazakhstan on RND and (or) RNT. | Major violation |
434 |
Presence of supporting documentation on the main tasks and areas of activity of entities rendering medical care in the field of nuclear medicine and observance of the main objectives: | Major violation |
435 | Presence of supporting documentation on the delivery of medical care using nuclear medicine methods within the guaranteed scope of free medical care, voluntary medical insurance and on a paid basis. | Gross violation |
436 |
Presence of supporting documentation on the delivery of specialised medical care in the field of nuclear medicine in outpatient, inpatient substitution, inpatient conditions in a planned form: | Major violation |
437 | Presence of supporting documentation on referral of patients for PET/CT, PET/MRI, SPECT, SPECT/CT studies to the RND department by relevant experts | Major violation |
438 | Presence of supporting documentation on conducting radioisotope (radionuclide) studies following clinical protocols, documented procedures, the specific diagnostic method used, with mandatory compliance with radiation safety measures for the patient and personnel as indicated | Gross violation |
439 | A signed informed consent of the patient for radioisotope (radionuclide) examination prior to undergoing this examination, indicating the activity of the RPMP used, after which the patient is examined by a physician and a nurse. | Major violation |
440 | Presence of supporting documentation on the nuclear medicine specialist interpreting the results of the examination after completion of the diagnostic procedure. In complicated cases with mandatory “double-read”, double dependent reading (the image is read twice; during the second reading the result of the first reading is available), PET, PET/CT, PET/MRI, SPECT, SPECT/CT studies by nuclear medicine specialists and a final diagnostic report is issued. | Gross violation |
441 |
Presence of supporting documentation on referral of patients to the RNT department after preliminary examination and clinical decision on the need for RNT with the participation of the head of the department or nuclear medicine physician as per the list of diseases for RNT. A referral for inpatient medical care for oncological diseases is issued by a multidisciplinary group established in health care facilities rendering oncological care; | Gross violation |
442 | Presence of supporting documentation of RNT in inpatient settings in ‘active’ wards and/or beds. After receiving RPMP, the patient is a source of beta-gamma radiation, therefore, daily rounds of the doctor are conducted via audio and video communication. The radiation safety engineer (dosimetrist) registers the dose rate from patients daily via an alarm meter and a stationary dose rate measurement system. | Gross violation |
443 |
Presence of supporting documentation on delivery of the cadaver of a patient with administered RPMP of “active” wards to a specially allocated freezing chamber located in the radionuclide support unit of the RNT unit (in the radioactive waste storage facility) in case of lethal outcome. The corpse is held in the freezing chamber until an acceptable level of radioactive decay (at a distance of 1 metre from the body surface - 20 µSv/h), then the corpse is transported. | Gross violation |
444 |
Presence of documentation (internal orders, regulations, protocols, questionnaires, analyses) of the clinical audit by the Patient Support Service and internal expertise and its evaluation against the following criteria: | Major violation |
445 | Availability of supporting documentation of record-keeping and accounting records | Minor violation |
Note:
HIV - human immunodeficiency virus
STI - sexually transmitted infections
CDC - consultative and diagnostic care
MDG - multidisciplinary group
PS psychoactive substances
PHC - primary health care
PFSIS - a psychiatric facility of a specialised type with intensive supervision
MBD - mental, behavioural disorders
ATM - antituberculosis medicines
PMHC - primary mental health centre
RSHF - republican state health care facility engaged in the prevention of HIV infection
RSPCMH - republican scientific and practical centre for mental health
EMC - emergency medical service
EHCS - emergency health care service
CVD - cardiovascular disease
MHC - mental health centre
EIS - electronic information system
RND - radioisotope (radionuclide) diagnostics
RNT - radionuclide therapy
RPMP - radiopharmaceutical medicinal product
PET/CT - positron emission tomography combined with a computed tomography scanner
SPECT - single photon emission computed tomography scanner
| Annex 3 to the Criteria for Evaluating the Level of Risk in the Delivery of Health Services (Care) |
List of subjective criteria for establishing the degree of risk by
subjective criteria in the sphere of health services (care) provision)
___________________________________________________________________
under Article 138
___________________________________________________________________
Entrepreneurial Code of the Republic of Kazakhstan in respect of entities (facilities)
offering outpatient and polyclinic care (primary medical and sanitary care and consultative and diagnostic care)
_____________________________________________________________________
name of a homogeneous group of entities (facilities)
____________________________________________________________ under control
№ s/o | Subjective criterion indicator | Source of information on the subjective criterion indicator |
Specific weight by significance, point (the total should not exceed 100 points), | Conditions /values, xi | ||
condition 1/value | condition 2/value | condition 3/value | ||||
1 | 2 | 3 | 4 | 5 | ||
For preventive control with visits | ||||||
1 | Failure to execute recommendations issued as a result of preventive control without visiting the entity (facility) under control | findings of preventive control without visiting the entity (facility) under control (final documents issued based on the findings of preventive control without visiting the entity (facility) under control). | 100.0 | no | yes | |
0% | 100% | |||||
2 | Annual pregnancy rate of women of fertile age with extragenital pathology for whom pregnancy is absolutely contraindicated - | results of monitoring of reports and data supplied by the entity under control | 10.0 | 0-1.9% | between 2% and 4.0% of cases | more than 4 per cent of cases |
0% | 50% | 100% | ||||
3 | Number of stroke deaths (ICD-10 code - I63) at home within 1 month after discharge | results of monitoring of reports and data supplied by the entity under control | 25.0 | 0 to 4 cases | Between 5 and 9 cases | more than 10 cases |
0% | 50% | 100% | ||||
4 | Proportion of hospitalisations of patients with complications of cardiovascular diseases (arterial hypertension, myocardial infarction, stroke) | results of monitoring of reports and data supplied by the entity under control | 10.0 | 0-9.9% | 10% -19.9% cases | more than 20 per cent of cases |
0% | 50% | 100% | ||||
5 | Annual indicator of the proportion of patients with acute cerebral circulation disorder registered after discharge from hospital within 3 working days at the place of registration - | results of monitoring of reports and data supplied by the entity under control | 10.0 | 0 % cases | 0-9.9% cases | From 10% of cases |
0% | 50% | 100% | ||||
6 | Proportion of deaths from circulatory system diseases out of total number of deaths, with ICD-10 diagnosis (I00-I99) | results of monitoring of reports and data supplied by the entity under control | 25.0 | 0-10 % | 10.01 –19.9% cases | more than 20 per cent of cases |
0% | 50% | 100% | ||||
7 | Annual rate of first-time detected patients with malignant neoplasms of stage 3-4 - | results of monitoring of reports and data supplied by the entity under control | 10.0 | 0-9.9% | More than 10% | |
0 | 100 % | |||||
8 | Number of child deaths from 0-5 years of age | results of monitoring of reports and data supplied by the entity under control | 100.0 | no | yes | |
0 | 1 and more | |||||
9 | Number of maternal deaths | results of monitoring of reports and data supplied by the entity under control | 100.0 | no | yes | |
0 | 1 and more | |||||
For compliance inspections | ||||||
1 | Certificate of a professional for admission to clinical practice |
results of monitoring of reports and data presented by the entity under control | 50 | There is a certificate | There is no certificate | |
0% | 100% | |||||
2 | The fact of re-registration of the licensee, change of its name or legal address and (or) reorganisation of the legal entity-licensee | results of analysis of data provided by public authorities and entities | 50 | yes | no | |
0% | 100% | |||||
| Annex 4 to the Criteria for Evaluating the Level of Risk in the Delivery of Health Services (Care) |
List of subjective criteria for establishing the degree of risk based on subjective criteria
in the area of quality of health care services (care)
_________________________________________________________________
as per Article 138
_________________________________________________________________
of the Entrepreneurial Code of the Republic of Kazakhstan in respect of
_________________________________________________________________
entities (facilities) offering in-patient, in-patient substitute care
____________________________________________________
name of a homogeneous group of entities (facilities)___________being controlled
№ s/o | Subjective criterion indicator | Source of information on the subjective criterion indicator | Specific weight by significance, point (the total should not exceed 100 points), wi | Conditions /values, xi | ||
condition 1/value | condition 2/value | condition 3/value | ||||
1 | 2 | 3 | 4 | 5 | ||
For preventive control with visits | ||||||
1 | Non-fulfilment of recommendations issued following the findings of preventive control without a visit to the entity (facility) under control | findings of preventive control without visiting the entity (facility) under control (final documents issued based on the findings of preventive control without visiting the entity (facility) under control). | 100.0 | no | yes | |
0% | 100% | |||||
2 | Postoperative mortality rate in cases of planned hospitalisation - | results of monitoring of reports and data supplied by the entity under control | 25.0 | 0-4.9% | 5-10.0% cases | more than 10 per cent of cases |
0% | 50% | 100% | ||||
3 | Annual rate of repeat unplanned hospitalisations (within a month for the same illness) - | results of monitoring of reports and data supplied by the entity under control | 10.0 | 0-5% cases | 5.01-10% cases | more than 10 per cent of cases |
0% | 50% | 100% | ||||
4 | Annual mortality rate for planned hospitalisations | results of monitoring of reports and data supplied by the entity under control | 25.0 | 0 cases | more than 1 case | |
0% | 100% | |||||
5 | Number of child deaths from 0-5 years of age | results of monitoring of reports and data supplied by the entity under control | 100.0 | no | yes | |
0 | 1 and more | |||||
6 | Number of maternal deaths | results of monitoring of reports and data supplied by the entity under control | 100.0 | no | yes | |
0 | 1 and more | |||||
For compliance inspections | ||||||
1 | Certificate of a professional for admission to clinical practice |
results of monitoring of reports and data presented by the entity under control | 50 | There is a certificate | There is no certificate | |
0% | 100% | |||||
2 | The fact of re-registration of the licensee, change of its name or legal address and (or) reorganisation of the legal entity-licensee | results of analysis of data reported by public authorities and entities | 50 | yes | no | |
0% | 100% | |||||
| Annex 5 to the Criteria for Evaluating the Level of Risk in the Delivery of Health Services (Care) |
List of subjective criteria for establishing the degree of risk based on subjective criteria
in the area of quality of health care services (care)
_________________________________________________________________
as per Article 138
_________________________________________________________________
of the Entrepreneurial Code of the Republic of Kazakhstan in respect of
_________________________________________________________________
entities (facilities), obstetric and (or) inpatient facilities with maternity wards
and neonatal pathology wards newborns ________________________________
name of a homogeneous group of entities (facilities)
_________________________________________________________ being controlled
№ s/o | Subjective criterion indicator | Source of information on the subjective criterion indicator |
Specific weight by significance, point (the total should not exceed 100 points), | Conditions /values, xi | ||
condition 1/value | condition 2/value | condition 3/value | ||||
1 | 2 | 3 | 4 | 5 | ||
For preventive control with visits | ||||||
1 | Failure to fulfil recommendations issued as a result of preventive control without visiting the entity (facility) under control | findings of preventive control without visiting the entity (facility) under control (final documents issued based on the results of preventive control without visiting the entity (facility) under control). | 100.0 | no | yes | |
0% | 100% | |||||
2 | Number of child deaths from 0-5 years of age | results of monitoring of reports and data supplied by the entity under control | 100.0 | no | yes | |
0 | 1 and more | |||||
3 | Number of maternal deaths | results of monitoring of reports and data supplied by the entity under control | 100.0 | no | yes | |
0 | 1 and more | |||||
4 | Annual mortality rate for planned hospitalisations | results of monitoring of reports and data supplied by the entity under control | 25.0 | 0 cases | more than 1 case | |
0% | 100% | |||||
5 | Ratio of emergency and planned Caesarean sections | results of monitoring of reports and data supplied by the entity under control | 10.0 | 0-10 % cases | 10.1-24.9% cases | more than 25 % of cases |
0% | 50% | 100% | ||||
6 | Proportion of birth injury cases | results of monitoring of reports and data supplied by the entity under control | 10,0 | 0-10 % cases | 10.1-19.9% cases | more than 20 % of cases |
0% | 50% | 100% | ||||
7 | Postoperative mortality rate in cases of planned hospitalisation - | results of monitoring of reports and data supplied by the entity under control | 25.0 | 0-4.9% | 5-9.9% cases | more than 10 % of cases |
0% | 50% | 100% | ||||
8 | Number of cases of intrapartum fetal death in a health care facility in the absence of CHD ( excluding charts with a final major, concomitant, or clarifying diagnosis with ICD-10 code Q00-Q99.9) | results of monitoring of reports and data supplied by the entity under control | 25.0 | 0 | 1 case | |
0% | 100% | |||||
9 | Rate of repeat unplanned admissions (within one month for the same condition) (female pelvic inflammatory disease (N70-N77) | results of monitoring of reports and data supplied by the entity under control | 10.0 | 0-4.99 % cases | 5-9.9 % cases | more than 10 per cent of cases |
0 | 50 % | 100 % | ||||
For compliance inspections | ||||||
1 | Certificate of a specialist for admission to clinical practice | results of monitoring of reports and data supplied by the entity under control (e-license) | 50 | There is a certificate | There is no certificate | |
0% | 100% | |||||
2 | The fact of re-registration of the licensee, change of its name or legal address and (or) reorganisation of the legal entity-licensee | findings of the analysis of data presented by public authorities and entities | 50 | yes | no | |
0% | 100% | |||||
| Annex 6 to the Criteria for Evaluating the Level of Risk in the Delivery of Health Services (Care) |
List of subjective criteria for establishing the degree of risk based on subjective criteria
in the delivery of health care services (care)
___________________________________________________________________
pursuant to Article 138
___________________________________________________________________
of the Entrepreneurial Code of the Republic of Kazakhstan in respect of
___________________________________________________________________
entities (facilities) offering cardiological, cardiosurgical and cardiosurgical care____
___________________________________________________________________
name of a homogeneous group of entities (facilities)
___________________________________________________________ being controlled
№ s/o | Subjective criterion indicator | Source of information on the subjective criterion indicator | Specific weight by significance, point (the total should not exceed 100 points),wi | Conditions /values, xi | ||
condition 1/value | condition 2/value | condition 3/value | ||||
1 | 2 | 3 | 4 | 5 | ||
For preventive control with visits | ||||||
1 | Failure to fulfil recommendations issued as a result of preventive control without visiting the entity (facility) under control | findings of preventive control without visiting the entity (facility) being controlled (final documents issued based on the findings of preventive control without visiting the entity (facility) being controlled). | 100.0 | no | yes | |
0% | 100% | |||||
2 | Number of stroke deaths (ICD-10 code - I63) at home within 1 month after discharge | results of monitoring of reports and information presented by the entity under control | 25.0 | 0 to 4 cases | Between 5 and 9 cases | over 10 cases |
0% | 50% | 100% | ||||
3 | Proportion of hospitalisations of patients with complications of cardiovascular diseases (arterial hypertension, myocardial infarction, stroke) | findings of monitoring of reports and information presented by the entity under control | 10.0 | 0 | 1- 19.9% cases | more than 20 per cent of cases |
0% | 50% | 100% | ||||
4 | Proportion of deaths from circulatory diseases out of total number of deaths, with ICD-10 diagnosis (I00-I99) | results of monitoring of reports and data supplied by the entity under control | 25.0 | 0-10 % | 10.1 – 20% cases | more than 20 per cent of cases |
0% | 50% | 100% | ||||
5 | The rate of postoperative mortality in cases of planned hospitalisation - | findings of monitoring of reports and data supplied by the entity subject to control | 25.0 | 0-4.9% | 5-10% cases | more than 10 per cent of cases |
0% | 50% | 100% | ||||
6 | Annual rate of repeat unplanned hospitalisations (within a month for the same illness) - | findings of monitoring of reports and data supplied by the entity subject to control | 10.0 | 0-5% cases | 5.1-10% cases | more than 10 per cent of cases |
0% | 50% | 100% | ||||
7 | Annual mortality rate for planned hospitalisations | findings of monitoring of reports and data supplied by the entity subject to control | 25.0 | 0 cases | more than 1 case | |
0% | 100% | |||||
8 | Number of child deaths from 0-5 years of age | findings of monitoring of reports and data supplied by the entity subject to control | 100.0 | no | yes | |
0 | 1 or more | |||||
9 | Number of maternal deaths | findings of monitoring of reports and data supplied by the entity subject to control | 100.0 | no | yes | |
0 | 1 or more | |||||
For compliance inspections | ||||||
1 | Specialist certificate for admission to clinical practice | findings of monitoring of reports and data supplied by the entity subject to control | 50 | There is a certificate | There is no certificate | |
0% | 100% | |||||
2 | The fact of re-registration of the licensee, change of its name or legal address and (or) reorganisation of the legal entity-licensee | findings of the analysis of data presented by public authorities and entities | 50 | yes | no | |
0% | 100% | |||||
| Annex 7 to the Criteria for assessing the degree of Risk assessment criteria in the sphere of rendering medical services (assistance) |
List of subjective criteria for determining the degree of risk by subjective criteria
in the sphere of medical services (assistance)
___________________________________________________________________
in accordance with Article 138
___________________________________________________________________
Entrepreneurial Code of the Republic of Kazakhstan in respect of
___________________________________________________________________
entities (facilities) providing haemodialysis care
___________________________________________________________________
name of homogeneous group of entities (facilities)
__________________________________________________________ of control
№ r/n | Indicator of the subjective criterion | Source of information on the subjective criterion indicator |
Weight by importance, point (the total should not exceed 100 points), | Conditions /values, xi | ||
condition 1/values | condition 2/values | condition 3/values | ||||
1 | 2 | 3 | 4 | 5 | ||
For preventive control with a visit | ||||||
1 |
Failure to fulfil recommendations issued as a result of preventive control without visiting the subject (object) of control |
results of preventive control without visiting the subject (object) of control (final documents issued based on the results of preventive control without visiting the entity (facility) of control). | 100,0 | no | yes | |
0% | 100% | |||||
3 | Annual mortality rate during planned hospitalisation | Results of monitoring of reports and information provided by the entity of control | 25,0 | 0 case | More than 1 case | |
0% | 100,0 | |||||
For compliance verifications | ||||||
1 |
Availability of a certificate of a specialist for admission to clinical practice |
results of monitoring of reports and information provided by the entity of control | 50 | With a certificate | Without a certificate | |
0% | 100% | |||||
2 | The fact of re-registration of the licensee, change of its name or legal address and (or) reorganisation of the legal entity-licensee | results of analysis of information provided by state bodies and organisations | 50 | yes | no | |
0% | 100% | |||||
| Annex 8 to the Criteria for assessing the degree of risk in the sphere of rendering medical services (assistance) |
List of subjective criteria for determining the degree of risk by subjective criteria
in the sphere of quality of medical services (care)
___________________________________________________________________
in accordance with Article 138
___________________________________________________________________
Entrepreneurial Code of the Republic of Kazakhstan in respect of
________________________________________________ entities (facilities),
providing dental care
___________________________________________________________________
name of homogeneous group of entities (facilities)
___________________________________________________________ of control
№ r/n | Indicator of the subjective criterion | Source of information on the subjective criterion indicator |
Weight by importance, point (the total should not exceed 100 points), | Conditions /values, xi | ||
condition 1/values | condition 2/values | condition 3/values | ||||
1 | 2 | 3 | 4 | 5 | ||
For preventive control with a visit | ||||||
1 |
Failure to fulfil recommendations issued as a result of preventive control without visiting the entities (facilities) of control |
results of preventive control without visiting the entities (facilities) of control (final documents issued based on the results of preventive control without visiting the entities (facilities) of control). | 100,0 | no | yes | |
0% | 100% | |||||
3 | Number of child deaths from 0-5 years of age | Results of monitoring of reports and information provided by the entity of control | 100,0 | no | yes | |
0 | 1 and more | |||||
For compliance inspections | ||||||
1 |
Availability of a certificate of a specialist for admission to clinical practice |
results of monitoring of reports and information provided by the entity of control | 50 | With a certificate | Without a certificate | |
0% | 100% | |||||
2 | The fact of re-registration of the licensee, change of its name or legal address and (or) reorganization of the legal entity-licensee | results of analysis of information provided by state bodies and organizations | 50 | yes | no | |
0% | 100% | |||||
| Annex 9 to the Criteria for assessing the degree of risk in the sphere of rendering medical services (assistance) |
List of subjective criteria for determining the degree of risk by subjective criteria
in the sphere of medical services (assistance)
___________________________________________________________________
in accordance with Article 138
___________________________________________________________________
Entrepreneurial Code of the Republic of Kazakhstan in respect of
________________________________________________ entities (facilities),
providing phthisiatric care _name of homogeneous group of entities (facilities)
___________________________________________________________ of the control
№ r/n | Subjective criterion indicator | Source of information on the subjective criterion indicator |
Specific weight in terms of significance, point (the total should not exceed 100 points), | Conditions /values, xi | ||
condition 1/values | condition 1/values | condition 1/values | ||||
1 | 2 | 3 | 4 | 5 | ||
For preventive control with a visit | ||||||
1 |
Failure to fulfil recommendations issued as a result of preventive control without visiting the entities (facilities) of control |
results of preventive control without visiting the entities (facilities) of control (final documents issued based on the results of preventive control without visiting the entities (facilities) of control). | 100,0 | no | yes | |
0% | 100% | |||||
3 | Annual mortality rate during planned hospitalisation | Results of monitoring of reports and information provided by the entity of control | 25,0 | 0 cases | More than 1 case | |
0% | 100,0 | |||||
4 | The rate of postoperative mortality in cases of planned hospitalisation - | results of monitoring of information received from automated information systems | 25,0 | 0-4,9% | 5-9,9% of cases | More than 10% of cases |
0% | 50% | 100% | ||||
For compliance verifications | ||||||
1 | Availability of a certificate of a specialist for admission to clinical practice |
results of monitoring of reports and information provided by the entity of control | 50 | With a certificate | Without a certificate | |
0% | 100% | |||||
2 | The fact of re-registration of the licensee, change of its name or legal address and (or) reorganization of the legal entity-licensee | results of analysis of information provided by state bodies and organizations | 50 | yes | no | |
0% | 100% | |||||
| Annex 10 to the Criteria for assessing the degree of risk in the sphere of rendering medical services (assistance) |
List of subjective criteria for determining the degree of risk by subjective criteria
in the sphere of medical services (assistance)
___________________________________________________________________
in accordance with Article 138
___________________________________________________________________
Entrepreneurial Code of the Republic of Kazakhstan in respect of
________________________________________________ entities (facilities),
providing oncological care _name of homogeneous group
entities (facilities)__________________________________________________________ of control
№ r/n | Subjective criterion indicator | Source of information on the subjective criterion indicator |
Specific weight in terms of significance, point (the total should not exceed 100 points), | Conditions /values, xi | ||
condition 1/values | condition 1/values | condition 1/values | ||||
1 | 2 | 3 | 4 | 5 | ||
For preventive control with a visit | ||||||
1 |
Failure to fulfil recommendations issued as a result of preventive control without visiting the entities (facilities) of control |
results of preventive control without visiting the entities (facilities) of control (final documents issued based on the results of preventive control without visiting the entities (facilities) of control). | 100,0 | no | yes | |
0% | 100% | |||||
3 | Annual mortality rate during planned hospitalisation | Results of monitoring of reports and information provided by the entity of control | 25,0 | 0 case | More than 1 case | |
0% | 100,0 | |||||
4 | The rate of postoperative mortality in cases of planned hospitalisation - | results of monitoring of information received from automated information systems | 25,0 | 0-4,9% | 5-9,9% of cases | More than 10% of cases |
0% | 50% | 100% | ||||
5 | Annual rate of repeated unplanned admissions (within a month for the same illness) - | Results of monitoring of reports and information provided by the entity of control | 10,0 | 0-5% of cases | 5,1-10% of cases | More than 10% of cases |
0% | 50% | 100% | ||||
For compliance inspections | ||||||
1 |
Availability of a certificate of a specialist for admission to clinical practice |
results of monitoring of reports and information provided by the subject of control | 50 | With a certificate | Without a certificate | |
0% | 100% | |||||
2 | The fact of re-registration of the licensee, change of its name or legal address and (or) reorganization of the legal entity-licensee | results of analysis of information provided by state bodies and organizations | 50 | yes | no | |
0% | 100% | |||||
| Annex 11 | |
| to the Criteria for assessing the degree of risk in the sphere of rendering |
|
| medical services (assistance) |
List of subjective criteria for determining the degree of risk by subjective criteria
in the sphere of medical services (assistance)
___________________________________________________________________
in accordance with Article 138
___________________________________________________________________
Entrepreneurial Code of the Republic of Kazakhstan in respect of
________________________________________________ entities (facilities),
providing medical and social assistance in the field of mental health
___________________________________________________________________
name of homogeneous group of entities (facilities)
__________________________________________________________ of control
№ r/n | Subjective criterion indicator | Source of information on the subjective criterion indicator |
Specific weight in terms of significance, point (the total should not exceed 100 points), | Conditions /values, xi | ||
condition 1/values | condition 1/values | condition 1/values | ||||
1 | 2 | 3 | 4 | 5 | ||
For preventive control with a visit | ||||||
1 |
Failure to fulfil recommendations issued as a result of preventive control without visiting the entities (facilities) of control |
results of preventive control without visiting the entities (facilities) of control (final documents issued based on the results of preventive control without visiting the entities (facilities) of control). | 100,0 | no | yes | |
0% | 100% | |||||
2 | Annual mortality rate during planned hospitalisation of patients with mental and behavioural disorders, including substance use F00-F99 (Percentage of inpatient deaths out of the total number of patients discharged (discharged patient, died)). | results of monitoring of information received from automated information systems | 25,0 | 0-10 % of cases | 10,1-25% of cases | More than 25% of cases |
0% | 50% | 100% | ||||
3 | Presence of cases of inappropriate length of stay (3 beds/day or less) (The proportion (%) of inpatient discharges with a length of stay of 3 nights/day or less out of the total number of patients (discharged) with mental and behavioural disorders F00-F99, including those due to substance (ПАВ) use). | results of monitoring of information received from automated information systems | 10,0 | 0-10 % of cases | 10,1-20% of cases | More than 20 % of cases |
0% | 50% | 100% | ||||
For compliance inspections | ||||||
1 | Availability of a certificate of a specialist for admission to clinical practice |
results of monitoring of reports and information provided by the subject of control | 50 | With a certificate | Without a certificate | |
0% | 100% | |||||
2 | The fact of re-registration of the licensee, change of its name or legal address and (or) reorganization of the legal entity-licensee | results of analysis of information provided by state bodies and organizations | 50 | yes | no | |
0% | 100% | |||||
| Annex 12 to the Criteria for assessing the degree of risk in the sphere of rendering medical services (assistance) |
List of subjective criteria for determining the degree of risk by subjective criteria
in the sphere of medical services (assistance)
___________________________________________________________________
in accordance with Article 138
___________________________________________________________________
Entrepreneurial Code of the Republic of Kazakhstan in respect of
________________________________________________ entities (facilities),
providing laboratory services
___________________________________________________________________
name of homogeneous group of entities (facilities)
__________________________________________________________ of control
№ r/n | Subjective criterion indicator | Source of information on the subjective criterion indicator |
Specific weight in terms of significance, point (the total should not exceed 100 points), | Conditions /values, xi | ||
condition 1/values | condition 1/values | condition 1/values | ||||
1 | 2 | 3 | 4 | 5 | ||
For preventive control with a visit | ||||||
1 | Failure to fulfil recommendations issued as a result of preventive control without visiting the entities (facilities) of control | results of preventive control without visiting the entities (facilities) of control (final documents issued based on the results of preventive control without visiting the entities (facilities) of control). | 100,0 | no | yes | |
0% | 100% | |||||
For compliance inspections | ||||||
1 | Availability of a certificate of a specialist for admission to clinical practice | results of monitoring of reports and information provided by the facility of control (e-license) | 50 | With a certificate | Without a certificate | |
0% | 100% | |||||
2 | The fact of re-registration of the licensee, change of its name or legal address and (or) reorganization of the legal entity-licensee | results of analysis of information provided by state bodies and organizations | 50 | yes | no | |
0% | 100% | |||||
| Annex 13 to the Criteria for assessing the degree of risk in the sphere of rendering medical services (assistance) |
List of subjective criteria for determining the degree of risk by subjective criteria
in the sphere of medical services (assistance)
___________________________________________________________________
in accordance with Article 138
___________________________________________________________________
Entrepreneurial Code of the Republic of Kazakhstan in respect of
________________________________________________ entities (facilities),
providing ambulance medical aid, medical aid in the form of
air ambulance _________________________________________________
name of homogeneous group of entities (facilities)
__________________________________________________________ of control
№ r/n | Subjective criterion indicator | Source of information on the subjective criterion indicator |
Specific weight in terms of significance, point (the total should not exceed 100 points), | Conditions /values, xi | ||
condition 1/values | condition 1/values | condition 1/values | ||||
1 | 2 | 3 | 4 | 5 | ||
For preventive control with a visit | ||||||
1 | Number of cases of deviations from the time of arrival in the relevant category (for organisations providing emergency medical care) over the past year | results of monitoring of reports and information provided by the entity of control | 50,0 | 0-4 cases | 5-9 cases | More than 10 cases |
0% | 50% | 100% | ||||
2 | Number of repeat visits for the same incident within a 24-hour period in the past year | Results of monitoring of reports and information provided by the entity of control | 50,0 | 0-4 cases | 5-9 cases | More than 10 cases |
0% | 50% | 100% | ||||
3 | Failure to fulfil recommendations issued as a result of preventive control without visiting the entity (facility) of control | results of preventive control without visiting the entity (facility) of control (final documents issued based on the results of preventive control without visiting the entity (facility) of control). | 100,0 | no | yes | |
0% | 100% | |||||
For compliance inspections | ||||||
1 | Availability of a certificate of a specialist for admission to clinical practice |
results of monitoring of reports and information provided by the entity of control | 50 | With a certificate | Without a certificate | |
0% | 100% | |||||
2 | The fact of re-registration of the licensee, change of its name or legal address and (or) reorganization of the legal entity-licensee | results of analysis of information provided by state bodies and organizations | 50 | yes | no | |
0% | 100% | |||||
| Annex 14 to the Criteria for assessing the degree of risk in the sphere of rendering medical services (assistance) |
List of subjective criteria for determining the degree of risk by subjective criteria
in the sphere of medical services (assistance)
___________________________________________________________________
in accordance with Article 138
___________________________________________________________________
Entrepreneurial Code of the Republic of Kazakhstan in respect of
________________________________________________ entities (facilities),
carrying out activities in the area of HIV prevention
__________________________________________________________________
Name of homogeneous group of entities (facilities) of control
№ r/n | Subjective criterion indicator | Source of information on the subjective criterion indicator |
Specific weight in terms of significance, point (the total should not exceed 100 points), | Conditions /values, xi | ||
condition 1/values | condition 1/values | condition 1/values | ||||
1 | 2 | 3 | 4 | 5 | ||
For preventive control with a visit | ||||||
1 |
Failure to fulfil recommendations issued as a result of preventive control without visiting the entities (facilities) of control |
results of preventive control without visiting the entities (facilities) of control (final documents issued based on the results of preventive control without visiting the entities (facilities) of control). | 100,0 | no | yes | |
0% | 100% | |||||
For compliance inspections | ||||||
1 | Availability of a certificate of a specialist for admission to clinical practice |
results of monitoring of reports and information provided by the subject of control | 50 | With a certificate | Without a certificate | |
0% | 100% | |||||
2 | The fact of re-registration of the licensee, change of its name or legal address and (or) reorganization of the legal entity-licensee | results of analysis of information provided by state bodies and organizations | 50 | yes | no | |
0% | 100% | |||||
| Annex 15 to the Criteria for assessing the degree of risk in the sphere of rendering medical services (assistance) |
List of subjective criteria for determining the degree of risk by subjective criteria
in the sphere of medical services (assistance)
___________________________________________________________________
in accordance with Article 138
___________________________________________________________________
Entrepreneurial Code of the Republic of Kazakhstan in respect of
___________________________________________________________________
entities (facilities) carrying out activities in the field of blood service
___________________________________________________________________
name of homogeneous group of entities (facilities)
__________________________________________________________of control
№ r/n | Subjective criterion indicator | Source of information on the subjective criterion indicator |
Specific weight in terms of significance, point (the total should not exceed 100 points), | Conditions /values, xi | ||
condition 1/values | condition 1/values | condition 1/values | ||||
1 | 2 | 3 | 4 | 5 | ||
For preventive control with a visit | ||||||
1 |
Failure to fulfil recommendations issued as a result of preventive control without visiting the entities (facilities) of control |
results of preventive control without visiting the entities (facilities) of control (final documents issued based on the results of preventive control without visiting the entities (facilities) of control). | 100,0 | no | yes | |
0% | 100% | |||||
For compliance verifications | ||||||
1 | Availability of a certificate of a specialist for admission to clinical practice |
results of monitoring of reports and information provided by the entity of control | 50 | With a certificate | Without a certificate | |
0% | 100% | |||||
2 | The fact of re-registration of the licensee, change of its name or legal address and (or) reorganization of the legal entity-licensee | results of analysis of information provided by state bodies and organizations | 50 | yes | no | |
0% | 100% | |||||
| Annex 16 to the Criteria for assessing the degree of risk in the sphere of rendering medical services (assistance) |
List of subjective criteria for determining the degree of risk by subjective criteria
in the sphere of medical services (assistance)
__________________________________________________________________
in accordance with Article 138
__________________________________________________________________
Entrepreneurial Code of the Republic of Kazakhstan in respect of
__________________________________________________________________
entities (facilities) providing pathological anatomical diagnostics
__________________________________________________________________
name of homogeneous group of entities (facilities)
__________________________________________________________ of control
№ r/n | Subjective criterion indicator | Source of information on the subjective criterion indicator |
Specific weight in terms of significance, point (the total should not exceed 100 points), | Conditions /values, xi | ||
condition 1/values | condition 1/values | condition 1/values | ||||
1 | 2 | 3 | 4 | 5 | ||
For preventive control with a visit | ||||||
1 |
Failure to fulfil recommendations issued as a result of preventive control without visiting the entities (facilities) of control |
results of preventive control without visiting the entities (facilities) of control (final documents issued based on the results of preventive control without visiting the entities (facilities) of control). | 100,0 | no | yes | |
0% | 100% | |||||
For compliance verifications | ||||||
1 | Availability of a certificate of a specialist for admission to clinical practice |
results of monitoring of reports and information provided by the subject of control | 50 | With a certificate | Without a certificate | |
0% | 100% | |||||
2 | The fact of re-registration of the licensee, change of its name or legal address and (or) reorganization of the legal entity-licensee | results of analysis of information provided by state bodies and organizations | 50 | yes | no | |
0% | 100% | |||||
| Annex 17 to the Criteria for assessing the degree of risk in the sphere of rendering medical services (assistance) |
List of subjective criteria for determining the degree of risk by subjective criteria
in the sphere of medical services (assistance)
___________________________________________________________________
in accordance with Article 138
___________________________________________________________________
Entrepreneurial Code of the Republic of Kazakhstan in respect of
___________________________________________________________________
entities (facilities) providing assistance in the field of nuclear medicine
___________________________________________________________________
name of homogeneous group of entities (facilities)
___________________________________________________________ of control
№ r/n | Subjective criterion indicator | Source of information on the subjective criterion indicator |
Specific weight in terms of significance, point (the total should not exceed 100 points), | Conditions /values, xi | ||
condition 1/values | condition 1/values | condition 1/values | ||||
1 | 2 | 3 | 4 | 5 | ||
For preventive control with a visit | ||||||
1 |
Failure to fulfil recommendations issued as a result of preventive control without visiting the entities (facilities) of control |
results of preventive control without visiting the entities (facilities) of control (final documents issued based on the results of preventive control without visiting the entities (facilities) of control). | 100,0 | no | yes | |
0% | 100% | |||||
For compliance inspections | ||||||
1 | Availability of a certificate of a specialist for admission to clinical practice |
results of monitoring of reports and information provided by the subject of control | 50 | With a certificate | Without a certificate | |
0% | 100% | |||||
2 | The fact of re-registration of the licensee, change of its name or legal address and (or) reorganization of the legal entity-licensee | results of analysis of information provided by state bodies and organizations | 50 | yes | no | |
0% | 100% | |||||
| Annex 2 to the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated November 15, 2018 № RK MH-32 and the Minister of National Economy of the Republic of Kazakhstan dated November 15, 2018 № 70 |
Checklist
Footnote. Annex 2 – in the wording of the joint order of the Minister of Healthcare of the RK dated 29.05.2023 № 90 and the Minister of National Economy of the RK dated 29.05.2023 № 91 (shall enter into force upon expiry of ten calendar days after the day of its first official publication).
in the area of quality of health care delivery
_________________________________________________________________
in accordance with Article 138
_________________________________________________________________
Entrepreneurial Code of the Republic of Kazakhstan in respect of
______________________________________________ entities (facilities),
providing in-patient, in-patient substitute care
name of homogeneous group of control entities (facilities)
____________________________________________________________________
State body that appointed the inspection/preventive control
with a visit to the entity (facility) of control
____________________________________________________________________
____________________________________________________________________
Act on the appointment of an inspection/preventive control with a visit to the entities
(facilities) of control (facility) of control
_____________________________________________________________________
______________________________________________________________ №, date
Name of the entities (facilities) of control ________________________________
______________________________________________________________________
(Individual identification number), business identification number
of the entities (facilities) of control _____________________________________________
______________________________________________________________________
Address of residence ________________________________________________
___________________________________________________________
____________________________________________________________
№ | List of requirements | Complies with the requirements | Does not comply with the requirements |
1 | 2 | 3 | 4 |
1 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free-of-charge basis | ||
2 | Availability of a conclusion on the compliance of the health care entity to provide high-tech medical care | ||
3 | Presence of written voluntary consent of the patient or his/her legal representative in case of invasive interventions and therapeutic and diagnostic measures. | ||
4 |
Availability of supporting documentation (form № 085/y "emergency medical care team EMCT call card", admission and refusal of hospitalisation log, form № 001/y "medical card of an inpatient"), that the stay of the emergency medical care team or EMCT department in the hospital's emergency room shall not exceed 10 minutes (the time for transferring the patient to the emergency room doctor) from the moment of its arrival at the hospital, except in cases of emergency medical care in emergency situations. | ||
5 | Availability of supporting medical documentation (form № 001/y "Inpatient medical card") on hospitalisation of a severe patient in need of continuous monitoring of vital functions for medical reasons, by the decision of a Concilium and notification of the heads of healthcare organisations with subsequent transfer to another medical organisation according to the profile of the disease for further examination and treatment after stabilisation of the condition | ||
6 |
Availability of supporting documentation on the medical opinion of the emergency room doctor with a written justification of the refusal in the absence of indications for hospitalisation in a health care organisation (Journal of admissions and refusals of hospitalisation from medical information systems, certificate in form № 027/y (refusals of hospitalisation)). | ||
7 |
Presence of records in medical documentation (Journal of patient admission and refusals of hospitalisation from the MIS, scheduled hospitalisation coupons, "Medical card of an inpatient" (form № 001/y) on indications for hospitalisation: | ||
8 | Availability of supporting medical documentation (form № 001/y "Medical card of inpatient") on the examination of heavy patients by the head of the department on the day of admission, and daily thereafter. Patients in a moderately severe condition shall be examined at least once a week. The results of the patient's examination shall be recorded in the medical record with recommendations on further tactics of patient management with obligatory identification of the medical worker making the entries | ||
9 | The presence of an established clinical diagnosis in conjunction with the head of department no later than three working days from the day of the patient's admission to the health care organisation in form № 001/y "Medical card of inpatient". | ||
10 |
Availability of supporting documentation (Form № 001/y "Medical card of inpatient") on daily examination of patients in the hospital by the attending a physician, except for weekends and public holidays. In case of examination and appointment of additional diagnostic and therapeutic manipulations by the doctor on duty, appropriate entries shall be made in the medical record. If the patient's condition worsens, the doctor on duty notifies the head of the department and (or) the attending physician, approves changes in the process of diagnosis and treatment, and makes an entry in the medical record (paper and (or) electronic) version. | ||
11 |
Compliance with the requirements for planned hospitalisation: | ||
12 | Availability of medical records of consultations or Concilium in case of difficulty in identifying the diagnosis, ineffectiveness of the current treatment, as well as other indications | ||
13 |
Availability of medical documentation of compliance with discharge criteria, in particular: | ||
14 | A discharge summary shall be issued to the patient upon discharge, indicating the full clinical diagnosis, the scope of diagnostic tests, therapeutic measures and recommendations for further follow-up and treatment. Discharge data shall be entered into the information systems on a day-to-day basis, indicating the actual time of discharge. | ||
15 |
Availability of documentation on compliance with the requirements for transfusion of blood components and in case of complications (orders on establishment of the commission, algorithm of staff interaction, "Medical card of an inpatient" form № 001/y): | ||
16 |
Availability of supporting medical documentation on indications for hospitalisation in day hospital at outpatient and polyclinic health care organisations and in hospital at home: | ||
17 |
Availability of medical documentation on examination of individuals for HIV infection on clinical indications when the following diseases, syndromes and symptoms shall be detected: | ||
18 | Availability of an agreement for provision of paid medical services in healthcare organisations. Availability of documents establishing the fact of co-payment | ||
19 |
Availability of medical documentation on compliance with the following requirements during the examination of temporary incapacity for work, issuance of temporary incapacity for work and certificates of temporary incapacity for work (form № 001/y "Medical card of hospital patient", form № 052/y "Medical card of hospital patient", stubs of sheets of temporary incapacity for work of patients, form № 025/y "Journal for recording conclusions of medical advisory commission", form № 029/y "Book of registration of sheets of temporary incapacity for work", form № 037/y "Certificate of temporary incapacity for work", form № 037/y "Certificate of temporary incapacity for work", form № 037/y "Certificate of temporary incapacity for work", form № 037/y "Certificate of temporary incapacity for work". | ||
20 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analyses) of the clinical audit conducted by the Patient support service and internal expertise and its evaluation according to the following criteria: | ||
21 |
There is documentation of compliance with the following actions when performing pathological autopsies: | ||
22 | Availability of a written application from the spouse, close relatives or legal representatives of the deceased, or a written will be given by the person during his/her lifetime to release the corpse without a pathological anatomical autopsy, in the absence of suspicion of violent death | ||
23 | Availability of a medical worker's entry in the medical documentation with the subsequent collection of biological materials to determine the content of a psychoactive substance and recording the results in the medical record when signs of psychoactive substance use are detected during the application for medical assistance to a health care organisation without issuing a medical examination conclusion to establish the fact of psychoactive substance use and the state of intoxication. | ||
24 | Availability of medical documentation on treatment and diagnostic measures, medication, therapeutic nutrition and appropriate care of the patient from the moment of admission to the health care organisation (Medical card of an inpatient" form № 001/y) | ||
25 | Availability of medical documentation on the use of opportunities for consultation with relevant national organisations, through the telemedicine network in case of difficulties in verifying the diagnosis of the child and determining the tactics of management. If necessary, the child is transferred to specialised national organisations. | ||
26 | Medical documentation of supportive care (support for adequate feeding, water balance, pain control, fever management, oxygen therapy). | ||
27 | Medical documentation of the use of less painful, equally effective alternative treatments when available, to avoid unnecessary painful procedures | ||
28 | Availability of medical documentation on daily examination of the child by a doctor, examination by the head of the department (on admission on the first day, repeatedly at least once a week) | ||
29 |
Availability of medical documentation on compliance with the requirements of anaesthesia and resuscitation care: | ||
30 | Availability of medical documentation on compliance of treatment and diagnostic measures with the recommendations of clinical protocols | ||
31 | Availability of medical documentation on the provision of the first stage of medical rehabilitation for the main disease (form № 001/y "Medical card of an inpatient", "form № 047/y" rehabilitation card). | ||
32 | Availability of medical documentation on the examination by the head of the department upon admission of neurosurgical patients and subsequently, if necessary, on the disease (Medical card of an inpatient form № 001/y) |
Official(s) ____________________________________ ____________
position signature
________________________________________________________________________
surname, first name, patronymic (if any)
Head of the subject of control _______________________________ ____________
position signature
________________________________________________________________________
surname, first name, patronymic (if any)
Checklist
Footnote. Annex 3 - in the wording of the joint order of the Minister of Healthcare of the RK dated 29.05.2023 № 90 and the Minister of National Economy of the RK dated 29.05.2023 № 91 (shall enter into force upon expiry of ten calendar days after the date of its first official publication).
in the area of quality of health care delivery
___________________________________________________________________
in accordance with Article 138
___________________________________________________________________
Entrepreneurial Code of the Republic of Kazakhstan in respect of
___________________________________________________________________
entities (facilities) providing outpatient and polyclinic care
(primary medical and sanitary care and consultative-diagnostic
assistance)
___________________________________________________________________
name of a homogeneous group of control entities (facilities) ____________________
_____________________________________________________________________
State body that ordered the inspection/preventive control
with a visit to the entities (facilities) of control
___________________________________________________________________
___________________________________________________________________
Act on the appointment of an inspection/preventive control with a visit to the entities
(facilities) of control (facility) of control
____________________________________________________________________
_____________________________________________________________ №, date
Name of the entity (facility) of control _______________________________
_____________________________________________________________________
(Individual identification number), business identification number
of the entity (facility) of control ____________________________________________
_____________________________________________________________________
Address of residence_____________________________________________________
_____________________________________________________________________
№ | List of requirements | Complies with the requirements | Does not comply with the requirements |
1 | 2 | 3 | 4 |
1 | Availability of supporting documentation on the provision of medical care included in the guaranteed scope of free medical care and (or) the system of compulsory social health insurance on a free-of-charge basis | ||
2 | Presence of written voluntary consent of the patient or his/her legal representative for invasive interventions and therapeutic and diagnostic measures | ||
3 | Availability of medical records of an outpatient patient on compliance of treatment and diagnostic measures with the recommendations of clinical protocols | ||
4 |
Availability of documentation on compliance with the following requirements when organising and conducting a medical advisory board: | ||
5 |
Availability of documentation on compliance by primary health care organisations in conducting preventive medical examinations of target population groups: | ||
6 |
Availability of documentation on compliance with the levels of medical rehabilitation provision to patients: | ||
7 |
Availability of documentation on compliance of tuberculosis care at the outpatient and polyclinic level with the following requirements: | ||
8 |
Availability of documentation on compliance with the requirements for oncological care in the form of outpatient care: | ||
9 77 | Availability of mandatory confidential medical screening for HIV infection of individuals on clinical and epidemiological indications, including sexual partners of pregnant women, individuals who applied voluntarily and anonymously | ||
10 |
Documentation of compliance with the following measures by an obstetrician-gynaecologist when a woman applies for pregnancy at the peri-pregnancy stage and wishes to continue the pregnancy: | ||
11 |
Availability of documentation on compliance with the requirements of an obstetrician-gynaecologist for the provision and organisation of obstetric and gynaecological care to women during pregnancy, after childbirth, provision of family planning and reproductive health services, as well as prevention, diagnosis and treatment of gynaecological diseases of the reproductive system | ||
12 | Availability of results and additional data of follow-up examinations and investigations in the Individual card of pregnant and maternity women and the exchange card of pregnant and maternity women at each visit of a pregnant woman to an obstetrician-gynaecologist | ||
13 | Home patronage by a midwife or a patronage nurse for pregnant women who do not attend an appointment within 3 days of the scheduled date. | ||
14 | Availability of a medical advisory commission's opinion on the possibility of carrying a pregnancy in women with contraindications to pregnancy due to extragenital pathology. | ||
15 | Availability of an agreement for provision of paid medical services in healthcare organisations. Availability of documents establishing the fact of co-payment | ||
16 |
Availability of documentation on compliance by the paramedical staff of the medical unit of the educational organisation with the following requirements: | ||
17 |
Availability of medical documentation on compliance with the following requirements during the examination of temporary incapacity for work, issuance of temporary incapacity for work and certificates of temporary incapacity for work (form № 001/y "Medical card of inpatient patient", form № 052/y "Medical card of outpatient patient", stubs of sheets of temporary incapacity for work of patients, form № 025/y "Journal for recording conclusions of medical advisory commission", form № 029/y "Book of registration of sheets of temporary incapacity for work", form № 037/y "Certificate of temporary incapacity for work", form № 037/y "Certificate of temporary incapacity for work", form № 037/y "Certificate of temporary incapacity for work", form № 037/y "Certificate of temporary incapacity for work". | ||
18 |
Compliance with the following requirements when issuing a maternity leave and certificate of temporary incapacity for work: | ||
19 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analyses) of the clinical audit by the Patient Support Service and internal expertise and its evaluation according to the following criteria: | ||
20 | Availability of documentation on compliance with the requirements for the guaranteed volume of free medical care | ||
21 |
Availability of documentation on compliance with the requirements of surgical (abdominal, thoracic, coloproctological) care to patients at the outpatient and polyclinic level | ||
22 | Availability of documentation on compliance with the requirements of primary health care organisations for dynamic monitoring of individuals with chronic diseases, compliance with the frequency and timing of monitoring, mandatory minimum and frequency of diagnostic tests | ||
23 | Availability of documentation on compliance with the requirements for active home visits by primary health care workers | ||
24 |
Availability of documentation on compliance with the requirements for paediatric care: | ||
25 |
Availability of documentation on compliance with the requirements for traumatological and orthopaedic care at the outpatient and polyclinic level | ||
26 |
Availability of documentation on compliance with the requirements of neurological care at outpatient and polyclinic level | ||
27 |
Availability of documentation of compliance with nephrological care, which includes: | ||
28 |
Availability of documentation on compliance with the requirements of neurosurgical care in outpatient settings | ||
29 |
Availability of documentation on compliance with the requirements of neurological care at outpatient and polyclinic level | ||
30 | Reasoned execution of the notification of the expert conclusion of medical and social expertise, form № 031/e (availability of data for a comprehensive assessment of the state of the organism and the degree of restriction of life activity) |
Official(s) ____________________________________ ____________
position signature
________________________________________________________________________
surname, first name, patronymic (if any)
Head of the entity of control _______________________________ ____________
position signature
_________________________________________________________________________
surname, first name, patronymic (if any)
Checklist
Footnote. Annex 4 - in the wording of the joint order of the Minister of Healthcare of the RK dated 29.05.2023 № 90 and the Minister of National Economy of the RK dated 29.05.2023 № 91 (shall enter into force upon expiry of ten calendar days after the day of its first official publication).
in the area of quality of health care delivery
____________________________________________________________________
in accordance with Article 138
____________________________________________________________________
Entrepreneurial Code of the Republic of Kazakhstan in respect of
____________________________________________________________________
entities (facilities), obstetrical and (or) in-patient organisations,
having maternity wards and departments of pathology of new-borns
name of a homogeneous group of control entities (facilities)
____________________________________________________________________
State body that ordered the inspection/preventive control
with a visit to the entity (facility) of control
____________________________________________________________________
____________________________________________________________________
Act on the appointment of an inspection/preventive control with a visit to the entity (facility)
of control
(facility)) of control
____________________________________________________________________
_____________________________________________________________ №, date
Name of the entity (facility) of control ________________________________
______________________________________________________________________
(Individual identification number), business identification number
of the entity (facility) of control _____________________________________________
______________________________________________________________________
Address of residence ________________________________________________
______________________________________________________________________
№ | List of requirements | Complies with the requirements | Does not comply with the requirements |
1 | 2 | 3 | 4 |
1 | Availability of an opinion on the compliance of a healthcare entity to provide high-tech medical care when the organisation provides high-tech services, including in vitro fertilisation | ||
2 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free-of-charge basis | ||
3 | Presence of written voluntary consent of the patient or his/her legal representative for invasive interventions and therapeutic and diagnostic measures | ||
4 |
Availability of supporting documentation (emergency medical team call card form № 085/y, admission and refusal of hospitalisation log, inpatient medical card form № 001/y) that the stay of the emergency medical team or emergency medical care department in the hospital's emergency room shall not exceed 10 minutes (the time for transferring the patient to the emergency room doctor) from the moment of its arrival at the hospital, except in cases of emergency medical care in emergency situations. | ||
5 |
Availability of a medical report issued by the doctor of the emergency room with a written justification of the refusal in the absence of indications for hospitalisation in a health care organisation. | ||
6 |
Availability of supporting records in medical documentation on indications for hospitalisation: | ||
7 | There shall be records in the medical records of the examination of heavy patients by the head of the department on the day of admission, and daily thereafter. Patients in a moderately severe condition shall be examined at least once a week. Presence of the results of the patient's examination recorded in the medical record with recommendations on further tactics of patient management with obligatory identification of the medical worker making the entries | ||
8 | Presence of records in the medical records confirming the daily examination of inpatients by the attending physician, except for weekends and public holidays. Appropriate entries in the medical records for examination and prescription of additional diagnostic and therapeutic manipulations by the doctor on duty | ||
9 | Justification in the medical record for dynamic assessment of the patient's condition according to clinical protocols of diagnosis and treatment when additional and repeated tests performed before hospitalisation in primary health care or other health care organisations shall be identified for medical reasons | ||
10 |
Availability of supporting documentation that the following requirements shall have been met when issuing a maternity leave and certificate of temporary disability: | ||
11 |
Availability of medical documentation on compliance with the following requirements during the examination of temporary incapacity for work, issuance of certificates and certificates of temporary incapacity for work (form № 001/y "Medical card of inpatient patient", form № 052/y "Medical card of outpatient patient", stubs of certificates of temporary incapacity for work of patients, form № 025/y "Journal for recording conclusions of medical advisory commission", form № 029/y "Book of registration of certificates of temporary inability to work", form № 037/y "Certificate №__________ on temporary disability of a student, college student, vocational school, sickness, quarantine and other reasons for absence of a child attending school, pre-school organisation (underline)", form № 038/y "Certificate №______ on temporary disability" and others): | ||
12 | Availability of informed written consent of the patient for transfusion of blood components | ||
13 |
There shall be records in the medical documentation on compliance with the requirements for transfusion of blood components. | ||
14 |
There shall be documentation of compliance with the following actions when performing pathological autopsies: | ||
15 |
Availability of supporting documentation on compliance with the following requirements in the organisation of obstetric and gynaecological care at the outpatient and polyclinic level: | ||
16 | The use of sex cells, tissues of reproductive organs by a recipient who is (are) married (spouse) shall be carried out with the written consent of both spouses. | ||
17 | Availability of supporting documentation on the birth of 10 (ten) children from one donor 6 which is the basis for termination of the use of this donor for recipients. | ||
18 |
Availability of supporting documentation on donation of germ cells, tissues of reproductive organs from the donor under the following conditions: | ||
19 | Oocyte donation shall be carried out with the donor's written informed consent for superovulation induction or in a natural cycle in compliance with the requirements for donors of germ cells, tissues of reproductive organs, and oocyte donors undergo medical and genetic examinations. | ||
20 |
Availability of supporting documentation on in vitro fertilisation (hereinafter referred to as IVF) using donor oocytes shall be carried out according to the indications: | ||
21 | Availability of supporting documentation on work with donors by an obstetrician-gynaecologist (reproductologist), medical examination of the donor before each procedure of donor material collection, controls the timeliness and results of laboratory tests in accordance with the calendar plan of examination. | ||
22 |
Availability of supporting documentation on oocyte donation according to the following algorithm: | ||
23 |
Availability of supporting documentation of compliance with the requirements for refusal of IVF using donor oocytes for the following contraindications: | ||
24 |
Availability of supporting documentation on the use of donor sperm in assisted reproductive methods and technologies (hereinafter referred to as the ART). Sexual abstinence shall be required for 3-5 days before sperm donation. Sperm shall be obtained by masturbation. The ejaculate shall be collected in a special sterile, pre-labelled container. This procedure shall be carried out in a special room with a separate entrance, appropriate interior, sanitary unit with a washbasin. In the absence of donor sperm in the medical organisation, or at the patient's request, donor sperm from other organisations that have a donor sperm bank is used. | ||
25 |
IVF with the use of donor sperm shall be performed when indicated | ||
26 | The individual donor card shall be filled out and coded by a doctor. The coding scheme shall be free. The donor's application and his/her individual card shall be kept in a safe as documents for official use. | ||
27 |
Availability of supporting documentation on work with donors by a doctor-uroandrologist and a doctor-embryologist. The doctor organises medical examinations of the donor, controls the timeliness and results of laboratory tests in accordance with the calendar plan of examination. | ||
28 |
Availability of supporting documentation of compliance, that the embryo donors shall be IVF patients who have unused cryopreserved embryos left in the bank. Upon free decision and written informed consent of the patients, these embryos shall be disposed of or donated to a medical organisation. Embryos transferred to the medical organisation shall be used for donation free of charge to infertile married couples, women (recipients) who shall not be married (matrimonial). | ||
29 | Availability of supporting documentation of compliance with assisted reproductive techniques and technologies | ||
30 |
Availability of supporting documentation of the following functions in the provision of pre-hospital care to women during and outside pregnancy by paramedics (obstetricians, paramedics, nurses/nurses): | ||
31 |
Availability of supporting documentation on compliance with the following requirements when organising obstetric and gynaecological care at the inpatient level: | ||
Provision of medical care to new-borns | |||
32 |
Availability of supporting documentation on compliance with the following requirements when organising medical care for new-borns at the inpatient level: | ||
33 |
Availability of supporting documentation on compliance with the requirements for the provision of medical care to new-borns in third-level medical organisations: | ||
34 | Supporting documentation of compliance with requirements to provide a healthy new-born with basic care, including prevention of hypothermia with "heat chain", skin-to-skin or skin-to-skin contact with the mother, early initiation of breastfeeding within the first hour (if the infant shows signs of readiness), and prevention of hospital-acquired infections. | ||
35 | Availability of supporting documentation of compliance with the requirements of healthy new-born anthropometry, full examination and other measures 2 hours after delivery | ||
36 | Availability of supporting documentation on compliance with the requirements of emergency medical care in case of detection of disorders of the new-born’s condition, transfer to the intensive care ward or neonatal intensive care unit, if indicated. | ||
37 |
Availability of supporting documentation of compliance with requirements for observation of the mother and healthy new-born in the labour ward by an obstetrician within two hours of birth: | ||
38 | Availability of supporting documentation of compliance with the transfer 2 hours after birth of a healthy new-born with the mother to a mother-baby unit | ||
39 | Supporting documentation of round-the-clock observation by medical staff and continuous involvement of the mother in the care of the child, except in cases of moderate and severe maternal conditions in the postnatal ward in the mother-baby wards. | ||
40 | Availability of supporting documentation on compliance with the requirements for dynamic monitoring of the new-born with timely detection of disorders of the new-born’s condition, conducting the necessary examination, examination by the head of the department, organisation of a Concilium to clarify the tactics of management. Provision of emergency medical care when indicated, timely transfer to an intensive care ward or neonatal intensive care unit | ||
41 |
Compliance with the requirements for medical workers in the wards of joint stay of mother and child: | ||
42 | A record in medical records of daily check-ups of new-borns by a neonatologist, consultations with mothers on care, prevention of hypothermia and vaccinations | ||
43 | Availability of supporting documentation on compliance with the requirements to organise consultations by specialised specialists, with therapeutic and diagnostic measures and recommendations to the mother on examination, treatment and rehabilitation in the presence of three or more developmental micro-anomalies or the detection of congenital pathology of new-borns. | ||
44 | Availability of supporting documentation on compliance with the requirements of medical care in case of emergency conditions in the new-born (asphyxia, respiratory distress syndrome, etc.) Stabilisation of its condition and determination of the degree of readiness for transportation with the mother to the second or third level obstetric care organisation. | ||
45 | Availability of supporting documentation on vaccination of new-borns on the basis of voluntary informed consent of parents (mother, father or legal representatives) for prophylactic vaccinations within the terms of prophylactic vaccinations in the Republic of Kazakhstan. | ||
46 | Availability of supporting documentation of compliance with the requirements for all new-borns to undergo neonatal screening for phenylketonuria, congenital hypothyroidism and audiological screening prior to discharge | ||
47 | Availability of supporting documentation on compliance with the requirements for a neonatologist to assess the severity of the condition, stabilise the condition, assess the degree of readiness for transport in the event of emergency conditions in the new-born, and arrange its transfer with the mother (in coordination with the obstetrician-gynaecologist) to a second- or third-level medical organisation. | ||
48 | Availability of supporting documentation on compliance with the requirements in case of suspicion and (or) detection of acute surgical pathology in a new-born, in case of emergency consultation of a doctor in the speciality "Paediatric surgery (neonatal surgery)". After stabilisation of vital signs, the new-born shall be transferred to the surgical department of another medical organisation (children's or multidisciplinary hospital) or to a neonatal (or paediatric) surgical department, if there is one within the structure of the obstetric medical organisation, to provide the appropriate specialised medical care. | ||
49 | Availability of supporting documentation on compliance with the requirements for transfer to a paediatric inpatient facility for premature new-borns after 28 days of age or premature new-borns after post-conceptional age of 42 weeks who require further round-the-clock medical care. | ||
50 | Mandatory pathological and anatomical examination of the foetus and placenta in cases of medical termination of pregnancy for suspected congenital anomalies in the foetus. | ||
51 | Documentation of clinical and pathological review of all maternal and infant deaths after all pathological investigations have been completed | ||
52 | Availability of an agreement for provision of paid medical services in healthcare organisations. Availability of documents establishing the fact of co-payment | ||
53 | Availability of medical documentation on the consultation of a paediatric cardiologist (cardiac surgeon) when a congenital malformation of the cardiovascular system shall be detected in obstetric institutions, and, if medically indicated, transfer of the new born to a specialised hospital. | ||
54 | Availability of medical documentation on the use of opportunities for consultation with relevant national organisations, through telemedicine network in case of difficulty in verifying the diagnosis of the child, determining the tactics of management. If it is necessary to transfer the child to specialised republican organisations. | ||
55 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analyses) of the clinical audit by the Patient support service and internal expertise and its evaluation according to the following criteria: | ||
Official(s) ____________________________________ ____________
position signature
________________________________________________________________________
surname, first name, patronymic (if any)
Head of the entity of control _______________________________ ____________
position signature
________________________________________________________________________
surname, first name, patronymic (if any)
| Annex 5 to the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated November 15, 2018 № RK MH-32 and the Minister of National Economy of the Republic of Kazakhstan dated November 15, 2018 № 70 |
Checklist
Сноска. Приложение 5 - в редакции cовместного приказа Министра здравоохранения РК от 29.05.2023 № 90 и Министра национальной экономики РК от 29.05.2023 № 91 (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).
in the area of quality of health care delivery
__________________________________________________________________
in accordance with Article 138
__________________________________________________________________
Entrepreneurial Code of the Republic of Kazakhstan in respect of
__________________________________________________________________
subjects (objects) providing cardiological, cardiac surgical care
name of homogeneous group of control entities (facilities)
___________________________________________________________________
State body that appointed the inspection/prophylactic control
with a visit to the entity (facility) of control
____________________________________________________________________
____________________________________________________________________
Act on the appointment of an inspection/preventive control with a visit to the entity (facility) of control
(facility) of control
____________________________________________________________________
_____________________________________________________________ №, date
Name of the entity (facility) of control _______________________________
_____________________________________________________________________
(Individual identification number), business identification number
of the entity (facility) of control ____________________________________________
_____________________________________________________________________
Address of residence _______________________________________________
_____________________________________________________________________
№ | List of requirements | Complies with the requirements | Does not comply with the requirements |
1 | 2 | 3 | 4 |
1. | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free-of-charge basis | ||
2. | Availability of medical documentation on the compliance of treatment and diagnostic measures with the recommendations of clinical protocols | ||
3. | Presence of written voluntary consent of the patient or his/her legal representative for invasive interventions and therapeutic and diagnostic measures. | ||
4. |
Availability of supporting documentation (emergency medical team call card form № 085/y, admission and refusal of hospitalisation log, medical card of an inpatient form № 001/y) that the stay of the emergency medical team or emergency medical care department in the emergency department of the hospital shall not exceed 10 minutes (the time for transferring the patient to the doctor of the emergency department) from the moment of its arrival at the hospital, except in cases of emergency medical care in emergency situations. | ||
5. | Availability of documentation on ensuring the hospitalisation of a serious patient in need of constant monitoring of vital functions for medical indications, by decision of a Concilium and notification of the heads of health care organisations with subsequent transfer to another medical organisation according to the profile of the disease for further examination and treatment after stabilisation of the condition | ||
6. |
A medical report with a written justification of refusal in the absence of indications for hospitalisation in a health care organisation shall be issued to the patient by the doctor of the reception department. | ||
7. |
Availability of supporting documentation on the indications for hospitalisation: | ||
8. | Severe patients shall be examined by the head of the department on the day of admission and daily thereafter. Patients in a moderately severe condition shall be examined at least once a week. The results of the patient's examination shall be recorded in the medical record with recommendations on further tactics of the patient's management with obligatory identification of the medical worker making the entries | ||
9. | Availability of supporting documentation on the establishment of the main diagnosis in emergency conditions within 24 (twenty-four) hours from the moment of the patient's admission to the 24-hour hospital on the basis of clinical and anamnestic examination data, results of instrumental and laboratory methods of research with recording in the medical record of an inpatient in form № 001/y, in stable patients - availability of the established clinical diagnosis in conjunction with the head of department no later than three calendar days from the date of admission to the hospital. | ||
10. |
Availability of supporting documentation of planned hospitalisation in the presence of indicators: | ||
11. |
Availability of documentation on urgent (round-the-clock, including weekends and public holidays) procedures, in particular: | ||
12. | Availability of documentation on admission to the catheterisation laboratory, bypassing the admission department, intensive care unit (ward) if the patient is diagnosed with acute coronary syndrome with segment elevation, acute myocardial infarction. | ||
13. |
Availability of documentation on ensuring daily examination by the attending physician of patients staying in the hospital except weekends and public holidays. When examining and prescribing additional diagnostic and treatment manipulations by the doctor on duty, appropriate entries are made in the medical record. If the patient's condition worsens, the doctor on duty notifies the head of the department and (or) the attending physician, agrees to make changes in the process of diagnosis and treatment, and makes an entry in the medical record (paper and (or) electronic) version. | ||
14. | Availability of documentation on the assessment of the complexity of surgical interventions for congenital heart disease according to the Aristotle Basic Scale and the effectiveness of operations in the cardiac surgical unit | ||
15. |
Availability of documentation on the compliance of medical care for patients with acute coronary syndrome and (or) acute myocardial infarction by levels of regionalisation: | ||
16. |
Availability of supporting documentation of compliance during planned hospitalisation: | ||
17. | Consultations or consultations in case of difficulty in identifying the diagnosis, ineffectiveness of the current treatment, as well as other indications | ||
18. |
Availability of supporting documentation during hospitalisation at the inpatient level: | ||
19. | Ensuring that a discharge summary shall be issued to the patient upon discharge, indicating the full clinical diagnosis, the scope of diagnostic tests, therapeutic measures and recommendations for further follow-up and treatment. Discharge data shall be entered into the information systems on a day-to-day basis, indicating the actual time of discharge | ||
20. |
Documentation of adherence to discharge criteria, such as: | ||
21. | Availability of an agreement for provision of paid medical services in healthcare organisations. Availability of documents establishing the fact of co-payment | ||
22. |
Documentation of compliance with blood component transfusion requirements and in case of complications: | ||
23. |
Availability of examination of individuals on clinical indications for HIV infection upon detection of the following diseases, syndromes and symptoms: | ||
24. |
Availability of medical documentation on compliance with the following requirements during the examination of temporary incapacity for work, issuance of certificates and certificates of temporary incapacity for work (form № 001/y "Medical Card of Inpatient Patient", form № 052/y "Medical card of outpatient patient", stubs of certificates of temporary incapacity for work of patients, form № 025/y "Journal for recording conclusions of medical advisory commission", form № 029y "Book of registration of certificates of temporary inability to work", form № 037/y "Certificate of temporary inability to work", form № 037y "Certificate of temporary inability to work", form № 037/y "Certificate of temporary inability to work". | ||
25. |
Compliance with the following requirements in the organisation and conduct of the medical advisory board: | ||
26. |
Availability of supporting documentation on indications for hospitalisation in day hospital at outpatient and polyclinic health care organisations and inpatient care at home: | ||
27. | Availability of a recovery and rehabilitation department | ||
28. | Availability of a cardiology room in the structure of organisations providing outpatient and polyclinic care to the population (district, city, region, republic) and organisations providing inpatient care | ||
29. | If it is impossible to establish the diagnosis of cardiovascular diseases in a primary health care organisation, the patient should be referred for consultation to a clinical diagnostic centre for the provision of Consultative and diagnostic polyclinic with a consultative meeting, if necessary, involving specialised specialists, including consultants from medical organisations at the national level. | ||
30. | Availability of supporting documentation of care provided to a patient with Consultative and diagnostic polyclinic by a specialised specialist on the referral of a renal replacement therapy specialist or other specialised specialist | ||
31. | Availability of an opinion on drawing up documents for referral for medical and social expert assessment in the presence of high blood pressure (crisis course), arrhythmia of various genesis, increased frequency of angina attacks and increasing symptoms of heart failure, issuance and extension of a sheet or certificate of temporary loss of working capacity, and in the case of permanent loss of working capacity (condition after myocardial infarction, aorto-coronary bypass, congestive heart failure) | ||
32. | Availability of supporting documentation on treatment and diagnostic measures, drug provision, organisation of therapeutic nutrition and appropriate care of the patient from the moment of admission to the health care organisation. | ||
33. | Availability of supporting documentation on the use of opportunities for consultation with relevant national organisations, via telemedicine network in case of difficulties in verifying the child's diagnosis and determining the tactics of management. If necessary, the child is transferred to specialised national organisations. | ||
34. | Provide supportive care (support adequate feeding, water balance, pain control, fever management, oxygen therapy) | ||
35. |
Availability of medical documentation on the provision of the following treatment and diagnostic measures as part of primary health care: | ||
36. | Availability of supporting documentation on the use of less painful alternative treatments, if available, that shall be equally effective, to avoid unnecessary painful procedures | ||
37. |
Availability of documentation on compliance with the requirements of anaesthesia and resuscitation care: | ||
38. |
Compliance with the following actions when performing pathological anatomical autopsy: | ||
39. | Availability of a written application from the spouse, close relatives or legal representatives of the deceased, or a written will be given by the person during his/her lifetime to release the corpse without a pathological anatomical autopsy, in the absence of suspicion of violent death | ||
40. |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analyses) of the clinical audit by the Patient support service and internal expertise and its evaluation according to the following criteria: | ||
41. | The patient shall be examined by a doctor in the admission department of an inpatient hospital with the completion of an inpatient card, if the patient or his/her legal representative has given written consent to the provision of medical care to the patient | ||
42. | Provision by a cardiologist (cardiac surgeon) of a consultative-diagnostic report in form № 075/y, indicating the results of the conducted examination and treatment, as well as further treatment of the patient with Diseases of the circulatory system to the primary care physician who referred the patient for consultative services in the course of personnel management provision | ||
43. | In the presence of abnormalities in blood pressure (crisis course), arrhythmias of various genesis, increased frequency of angina attacks and increasing symptoms of heart failure, the cardiologist of the medical organisation issues and extends a temporary disability certificate or certificate, and in case of persistent disability (after myocardial infarction, aorto-coronary bypass surgery, congestive heart failure), the cardiologist of the Ministry of Health issues an opinion on drawing up documents for referral for medical and social expert assessment (hereinafter referred to as the MSE) | ||
44. | Availability of documentation on emergency hospitalisation of a patient with Diseases of the circulatory system to the intensive care unit (ward), bypassing the emergency room in life-threatening cases | ||
45. | Availability of documentation on hospitalisation of a patient with an established diagnosis of acute coronary syndrome (hereinafter referred to as the ACS) with segment elevation, acute myocardial infarction (hereinafter referred to as the AMI) to the catheterisation laboratory, bypassing the admission department, intensive care unit (ward). | ||
46. |
Availability of documentation on the provision of cardiological (cardiac surgery) care in inpatient settings, which shall include: | ||
47. | Availability of documentation on the immediate transfer of a patient undergoing treatment in the medical organisation without the possibility of IV in case of identification of indications for urgent interventional or cardiac surgical interventions by ambulance, including medical aviation to the medical organisation with the possibility of IV in 24-hour mode. | ||
48. |
Availability of supporting documentation on the performance of surgical interventions in cardiac surgery according to the principle of regionalisation with regard to the level of complexity: |
Official(s) ____________________________________ ____________
position signature
________________________________________________________________________
surname, first name, patronymic (if any)
Head of the entity of control _______________________________ ____________
position signature
________________________________________________________________________
surname, first name, patronymic (if any)
Checklist
Footnote. Annex 6 - in the wording of the joint order of the Minister of Healthcare of the RK dated 29.05.2023 № 90 and the Minister of National Economy of RK dated 29.05.2023 № 91 (shall enter into force upon expiry of ten calendar days after the day of its first official publication).
in the area of quality of health care delivery
__________________________________________________________________
in accordance with Article 138
___________________________________________________________________
Entrepreneurial Code of the Republic of Kazakhstan in respect of
___________________________________________________________________
entities (facilities) providing haemodialysis care
___________________________________________________________________
name of a homogeneous group of control entities (facilities)
___________________________________________________________________
State body that ordered the inspection/prophylactic control
with a visit to the entity (facility) of control
_____________________________________________________________________
_____________________________________________________________________
Act on the appointment of an inspection/preventive control with a visit to the entity (facility)
of control
(facility) of control
_____________________________________________________________________
______________________________________________________________ №, date
Name of the entity (facility) of control _______________________________
_____________________________________________________________________
(Individual identification number), business identification number
of the entity (facility) of control _____________________________________________
______________________________________________________________________
Address of residence ________________________________________________
______________________________________________________________________
______________________________________________________________________
№ | List of requirements | Complies with the requirements | Does not comply with the requirements |
1 | 2 | 3 | 4 |
1 | Availability of written voluntary consent of the patient or his/her legal representative for invasive interventions and therapeutic and diagnostic measures | ||
2 | Availability of an opinion on the compliance of the health care entity to provide high-tech medical services | ||
3 | Availability of supporting documentation on the compliance of treatment and diagnostic measures with the recommendations of clinical protocols | ||
4 |
Availability of supporting documentation of eligibility for selection and initiation of renal replacement therapy, specifically: | ||
5 |
Availability of supporting documentation of compliance with the indication for emergency extrarenal blood purification in patients with acute renal failure: | ||
6 | Availability of supporting documentation that the haemodialysis machine shall comply with quality certificates, with sufficient life and capacity as stipulated by the country of manufacture | ||
7 |
Availability of supporting documentation on compliance with the algorithm of haemodialysis procedure: | ||
8 | Availability of supporting documentation on the provision of drugs and consumables according to the dialysis protocol | ||
9 | Availability of a water treatment system and compliance with requirements for preparation of haemodialysis fluids, quality of solutions for haemodialysis and blood purification system | ||
10 | Availability of a contract for provision of paid medical services in health care organisations. Availability of documents establishing the fact of co-payment | ||
11 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analyses) of the clinical audit by the Patient support service and internal expertise and its evaluation according to the following criteria: | ||
12 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free-of-charge basis | ||
13 | Availability of supporting documentation on record keeping and reporting documentation |
Official(s) ____________________________________ ____________
position signature
________________________________________________________________________
surname, first name, patronymic (if any)
Head of the entity of control _______________________________ ____________
position signature
________________________________________________________________________
surname, first name, patronymic (if any)
| Annex 7 to the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated November 15, 2018 № KR DSM-32 and the Minister of National Economy of the Republic of Kazakhstan dated November 15, 2018 № 70 |
Checklist
Footnote. Annex 7 - as amended by the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated 29.05.2003 № 90 and the Minister of National Economy of the Republic of Kazakhstan dated 29.05.2003 № 91 (shall come into effect ten calendar days after the day of its first official publication).
in the field of quality of medical services
___________________________________________________________________
in accordance with Article 138
___________________________________________________________________
of the Entrepreneurial Code of the Republic of Kazakhstan concerning
___________________________________________________________________
subjects (objects) providing dental care
___________________________________________________________________
name of a homogeneous group of subjects (objects) of control
___________________________________________________________________
State body that appointed the inspection/preventive control
with a visit to the subject (object) of control
___________________________________________________________________
___________________________________________________________________
Act on appointment of inspection/preventive control with a visit to the subject
(object) of control
___________________________________________________________________
____________________________________________________________ №, date
Name of the subject (object) of control ___________________________________
___________________________________________________________________
(Individual identification number), business identification number
of the subject (object) of control ________________________________________
__________________________________________________________________
Location address ____________________________________________________
__________________________________________________________________
__________________________________________________________________
№ | List of requirements | Meets requirements | Does not meet requirements |
1 | 2 | 3 | 4 |
1 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | ||
2 |
Availability of supporting documentation of compliance with the following requirements when organizing dental care: | ||
3 | Availability of an agreement for the provision of paid services in healthcare organizations. | ||
4 | Availability of medical documentation confirming compliance with clinical diagnostic studies at levels of dental care | ||
5 | Availability of form № 058/у "Medical record of a dental patient (including sanitation)" for each patient | ||
6 | Availability of supporting documentation on the compliance of the therapeutic and diagnostic measures carried out with the recommendations of clinical protocols. In the absence of clinical protocols, according to international standards and guidelines based on evidence-based medicine. | ||
7 | Availability of supporting documentation on the maintenance of accounting and reporting documentation by specialized experts working in healthcare organizations providing dental care | ||
8 | Availability of completed documentation with information about the provision of dental care (electronic medical records, related materials about the patient’s health status and diagnosis), including in the MIS for each tooth in the examination card of primary teeth and the examination card of permanent teeth | ||
9 | Availability of documentation on determining the allergy history of the patient before dental interventions requiring local anaesthesia, and, if indicated, referral of the patient to primary health care organizations or medical organizations for laboratory examination to identify drug allergies | ||
10 |
Availability of supporting documentation on the provision of dental care to children on an outpatient basis in the form of consultative and diagnostic assistance upon referral and self-referral shall include: | ||
11 | Availability of informed consent of parents or representatives when performing dental interventions on children associated with the risk of pain; manipulations shall be carried out according to indications using anaesthesia (local, sedation, general) | ||
12 |
Availability of supporting documentation on the provision of dental care to adults on an outpatient basis in the form of consultative and diagnostic assistance on self-referral and referral, which shall include: | ||
13 | Availability of supporting documentation on the provision of dental care in a hospital setting by oral and maxillofacial surgeons and includes prevention, diagnosis, treatment of diseases and conditions requiring the use of special medical methods and technologies, as well as medical rehabilitation | ||
14 | Availability of supporting documentation of the consultation or the use of remote medical services in the differential diagnosis of complex, unclear cases to verify the diagnosis | ||
15 | Children aged 0 to 17 years inclusive and pregnant women are subject to dynamic observation and dental examinations | ||
16 |
Availability of supporting documentation on the provision of preventive measures for pregnant women and adults, which shall include | ||
17 |
Compliance with the following requirements when organizing and conducting a medical advisory commission: | ||
18 |
Availability of medical documentation on compliance with the following requirements when examining temporary disability, issuing a sheet and certificate of temporary disability (form № 001/у "Medical record of an inpatient", form 052/у "Medical record of an outpatient", stubs of sheets on temporary disability of patients, form № 025/у "Journal for recording the conclusions of the medical consultation commission", form № 029/у "Book of registration of sheets on temporary incapacity for work", form № 037/у "Certificate №__________ on temporary incapacity for work of a student, college student, professional technical school, about illness, quarantine and other reasons for the absence of a child attending school, a preschool organization (underline as necessary)", form № 038/у "Certificate №______ on temporary disability" and others): | ||
19 | Availability of written voluntary consent of the patient or his/her legal representative for invasive interventions and for carrying out therapeutic and diagnostic measures | ||
20 |
Availability of supporting documentation on compliance with the requirements for the provision of anesthesiological and resuscitation care: | ||
21 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical reports) on the conduct of a clinical audit by the Patient Support and Internal Expertise Service and its assessment according to the following criteria: |
Official(s) ____________________________________ ____________
position signature
_________________________________________________________
surname, first name, patronymic (if any)
Head of the subject of control ____________________________ ____
position signature
_________________________________________________________
surname, first name, patronymic (if any)
| Annex 8 to the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated November 15, 2018 № KR DSM-32 and the Minister of National Economy of the Republic of Kazakhstan dated November 15, 2018 № 70 |
Checklist
Footnote. Annex 8 - as amended by the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated 29.05.2003 № 90 and the Minister of National Economy of the Republic of Kazakhstan dated 29.05.2003 № 91 (shall come into effect ten calendar days after the day of its first official publication).
in the field of quality of medical services
___________________________________________________________________
in accordance with Article 138
___________________________________________________________________
of the Entrepreneurial Code of the Republic of Kazakhstan concerning
___________________________________________________________________
subjects (objects) providing phthisiatric care
___________________________________________________________________
name of a homogeneous group of subjects (objects) of control
___________________________________________________________________
State body that appointed the inspection/preventive control
with a visit to the subject (object) of control
___________________________________________________________________
___________________________________________________________________
Act on the appointment of an inspection/preventive control with a visit to the subject
(object) of control
___________________________________________________________________
______________________________________________________________ №, date
Name of the subject (object) of control ___________________________________
___________________________________________________________________
(Individual identification number), business identification number
of the subject (object) of control _________________________________________
___________________________________________________________________
Location address _____________________________________________________
___________________________________________________________________
___________________________________________________________________
№ | List of requirements | Meets requirements | Does not meet requirements |
1 | 2 | 3 | 4 |
Providing anti-tuberculosis care at the outpatient clinic level | |||
1 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | ||
2 |
Availability of supporting documentation on the implementation by PHC specialists of the following activities: | ||
3 | Availability of supporting documentation for the examination of a patient for suspected tuberculosis in organizations providing primary health care according to this scheme | ||
4 | Availability of supporting documentation on the detection of tuberculosis using fluorography among the target population group: those at high risk of the disease and subject to mandatory annual fluorographic examination | ||
5 | Availability of supporting documentation on the organization of directly observed treatment rooms (hereinafter referred to as DOT) in primary health care organizations for outpatient treatment. The patient shall receive and take medications in the DOT office under the supervision of a responsible medical professional. Once every 10 days, patients undergoing direct supervised treatment shall be examined by a primary care physician/clinic phthisiatrician, or more often if indicated. Patients living in rural areas shall be examined by a phthisiatrician once a month | ||
6 |
An assessment of the clinical condition of a patient receiving anti-tuberculosis treatment for the presence of adverse reactions and events shall be carried out daily by the attending physician or phthisiatrician, or a medical worker in the directly observed treatment room. A medical professional who has identified adverse reactions and events to a drug shall fill out a report card and make an entry in the patient’s medical records. | ||
7 | Availability of records of the movement of anti-tuberculosis drugs at the outpatient level in the anti-tuberculosis drug registration log | ||
8 | Conducting a conversation with the patient (parents or guardians of children) before the start of treatment about the need for a full course of chemotherapy, followed by signing informed consent | ||
9 | Availability of supporting documentation on registration and dispensary observation of tuberculosis patients shall be carried out in organizations providing primary health care at the place of actual residence, work, study or military service, regardless of registration | ||
10 |
Availability of supporting documentation on compliance with the following requirements when organizing and conducting a medical advisory commission: | ||
11 |
Availability of supporting documentation regarding compliance with the levels of medical rehabilitation provided to patients: | ||
Providing anti-tuberculosis care at the hospital level | |||
12 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | ||
13 |
Distribution of patients in departments across wards, taking into account laboratory test data and drug sensitivity at the time of admission and during treatment. | ||
14 |
Availability of daily examination by a phthisiatrician of patients in the hospital. | ||
15 | Availability of supporting documentation on the organization of consultation in difficult situations to verify the diagnosis and determine treatment tactics with the participation of specialists at the regional and national levels in person or remotely via telemedicine | ||
16 | Availability of records of the movement of anti-tuberculosis drugs at the hospital level in the anti-tuberculosis drug registration log | ||
17 |
Availability of supporting documentation on compliance with the criteria for discharge of a tuberculosis patient from the hospital: | ||
18 | Availability of written voluntary consent of the patient or his/her legal representative for invasive interventions and for carrying out therapeutic and diagnostic measures | ||
19 | Availability of examination of severely ill patients by the head of the department on the day of hospitalization, and subsequently - daily. Patients in moderate condition shall be examined at least once a week. The results of the patient's examination shall be recorded in the medical record, indicating recommendations for further tactics of patient management with mandatory identification of the medical worker making the notes | ||
20 | Having an established clinical diagnosis together with the head of the department no later than three calendar days from the date of hospitalization of the patient in a healthcare organization | ||
21 | Availability of consultations or council in case of difficulty in identifying the diagnosis, ineffectiveness of the treatment, as well as for other indications | ||
22 | Availability of issuing a discharge summary to the patient upon discharge, indicating the full clinical diagnosis, the scope of diagnostic tests performed, treatment measures and recommendations for further observation and treatment. Data on the discharge shall be entered into information systems on the same day, indicating the actual time of discharge. | ||
23 |
Availability of supporting documentation on compliance with the requirements for the provision of anesthesiological and resuscitation care: | ||
24 |
Availability of supporting documentation on compliance with the requirements for transfusion of blood components and in the event of complications: | ||
25 |
Availability of examination of persons for clinical indications for HIV infection when identifying the following diseases, syndromes and symptoms: | ||
26 |
Availability of medical documentation on compliance with the following requirements when examining temporary disability, issuing a sheet and certificate of temporary disability (form № 001/у "Medical record of an inpatient", form 052/у "Medical record of an outpatient", stubs of sheets on temporary disability of patients, form № 025/у "Journal for recording the conclusions of the medical consultation commission", form № 029/у "Book of registration of sheets on temporary incapacity for work", form № 037/у "Certificate №__________ on temporary incapacity for work of a student, college student, professional technical school, about illness, quarantine and other reasons for the absence of a child attending school, a preschool organization (underline as necessary)", form № 038/у "Certificate №______ on temporary disability" and others): | ||
27 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical reports) on the conduct of a clinical audit by the Patient Support and Internal Expertise Service and its assessment according to the following criteria: | ||
28 |
Availability of documentation on compliance with the following actions when conducting a pathological autopsy: | ||
29 | Availability of a written statement from a spouse, close relatives or legal representatives of the deceased, or a written expression of will given by a person during his/her lifetime for the release of a corpse without performing a pathological autopsy, in the absence of suspicion of violent death | ||
30 | Availability of an agreement for the provision of paid medical services in healthcare organizations. Availability of documents establishing the fact of co-payment | ||
31 |
Availability of supporting documentation on the compliance of the levels of medical rehabilitation provided to patients: | ||
32 | Availability of a medical worker’s entry in the medical record with subsequent collection of biological materials to determine the content of a psychoactive substance with the results being entered into the medical record if signs of psychoactive substance use are detected when seeking medical help from a health care organization without issuing a Medical Examination Conclusion to establish the fact of psychoactive substance use and state of intoxication | ||
33 | Availability of supporting documentation on the compliance of the therapeutic and diagnostic measures carried out with the recommendations of clinical protocols. | ||
Official(s)____________________________________ ____________
position signature
_________________________________________________________
surname, first name, patronymic (if any)
Head of the subject of control __________________ ______________
position signature
_________________________________________________________
surname, first name, patronymic (if any)
Checklist
Footnote. Annex 9 - as amended by the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated 29.05.2003 № 90 and the Minister of National Economy of the Republic of Kazakhstan dated 29.05.2003 № 91 (shall come into effect ten calendar days after the day of its first official publication).
in the field of quality of medical services
___________________________________________________________________
in accordance with Article 138
___________________________________________________________________
of the Entrepreneurial Code of the Republic of Kazakhstan concerning
___________________________________________________________________
subjects (objects) providing oncological care
name of a homogeneous group of subjects (objects) of control
___________________________________________________________________
State body that appointed inspection/preventive control
with a visit to the subject (object) of control
___________________________________________________________________
___________________________________________________________________
Act on the appointment of an inspection/preventive control with a visit to the subject
(object) of control
___________________________________________________________________
______________________________________________________________ №, date
Name of the subject (object) of control ___________________________________
___________________________________________________________________
(Individual identification number), business identification number
of the subject (object) of control ________________________________________
__________________________________________________________________
Location address____________________________________________________
__________________________________________________________________
№ | List of requirements | Meets requirements | Does not meet requirements |
1 | 2 | 3 | 4 |
Providing oncological care at the outpatient clinic level | |||
1 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | ||
2 |
The presence of a multidisciplinary team (MDT) to provide an individual approach to providing medical care to patients with malignant neoplasms. | ||
3 |
Availability of supporting documentation on consideration at meetings of the MDT: | ||
4 |
Availability of supporting documentation about the organization of primary health care specialists: | ||
5 |
Availability of supporting documentation on the provision of consultative and diagnostic assistance, which shall include: | ||
6 |
Availability of supporting documentation on the referral of the patient’s GP to an oncologist or oncology care coordinator if a tumor disease is suspected or detected. | ||
7 |
Availability of supporting documentation of compliance with the requirements for the provision of oncological care in the form of outpatient care: | ||
8 |
Availability of supporting documentation on the conduct of IHC and molecular genetic studies to determine the molecular biological characteristics of tumours to individualize the treatment of patients, as well as to confirm (verify) the diagnosis of cancer. IHC studies shall be carried out at the level of pathological laboratories of organizations providing oncological care, secondary level and tertiary level reference centres and shall be carried out according to clinical protocols. | ||
9 | Availability of supporting documentation on international teleconsultations of tumor biosamples through the telepathology system to clarify the diagnosis in complex clinical cases. The duration of teleconsultations shall not exceed thirty working days | ||
10 |
Availability of supporting documentation about displaying in the MIS the entire period of examination of patients with suspected cancer in an outpatient setting, indicating markers of cancer alertness within the following examination periods: | ||
11 | Availability of supporting documentation that specialized treatment of a patient with MN shall begin no later than thirty calendar days from the date of diagnosis and placement under dynamic observation. | ||
12 |
Availability of supporting documentation on dynamic observation for clinical groups of patients with suspected MN and a confirmed diagnosis of MN: | ||
13 |
Patients with cancer shall be subject to lifelong medical dynamic observation in an organization providing medical care on an outpatient basis at the place of attachment - the primary level (III clinical group) and organizations providing oncological care at a secondary level (II clinical group) at the place of residence and attachment. | ||
14 | When a diagnosis of cancer is established for the first time, form № 034/у "Notification" shall be filled out for each patient, which shall be sent within three working days to the organization providing oncological care at the secondary level at the patient’s place of permanent residence for registration in the Electronic Register of Cancer Patients and registration, indicating the circumstances of the diagnosis (the patient’s self-referral to a medical organization PHC, CDA - primary level, the patient’s self-referral to an organization providing oncological care at the secondary and tertiary levels, the diagnosis was established during a screening examination, the diagnosis was established during a preventive examination). | ||
15 |
For each patient with a diagnosis of stage IV cancer for the first time in his/her life and with visually accessible stage III localizations, a protocol shall be filled out in case an advanced form of MN is detected in the patient (clinical group V). | ||
16 | Availability of mandatory confidential medical examination for the presence of HIV infection of persons for clinical and epidemiological indications, including sexual partners of pregnant women, persons who applied voluntarily and anonymously | ||
17 |
Availability of supporting documentation on compliance with indications for hospitalization in a day hospital at outpatient healthcare organizations and hospitalization at home: | ||
18 |
Availability of medical documentation on compliance with the following requirements when examining temporary disability, issuing a sheet and certificate of temporary disability (form № 001/у "Medical record of an inpatient", form 052/у "Medical record of an outpatient", stubs of sheets on temporary disability of patients, form № 025/у "Journal for recording the conclusions of the medical consultation commission", form № 029/у "Book of registration of sheets on temporary incapacity for work", form № 037/у "Certificate №__________ on temporary incapacity for work of a student, college student, professional technical school, about illness, quarantine and other reasons for the absence of a child attending school, a preschool organization (underline as necessary)", form № 038/у "Certificate №______ on temporary disability" and others): | ||
19 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical reports) on the conduct of a clinical audit by the Patient Support and Internal Expertise Service and its assessment according to the following criteria: | ||
Providing oncological care at the inpatient level | |||
20 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | ||
21 |
Availability of supporting documentation on the dilution of antitumor drugs in the rooms for centralized dilution of cytostatic drugs (hereinafter referred to as the RCDC) to ensure the safety of medical personnel from the toxic effects of anticancer drugs and the rational use of drugs. | ||
22 |
Availability of supporting documentation that radiation therapy shall be carried out according to the principle of "single doctor – radiation therapist (radiation oncologist)", which provides for clinical management of the patient, pre-radiation preparation and radiation treatment by one doctor – radiation therapist (radiation oncologist). | ||
23 |
Availability of supporting documentation that in inpatient conditions, patients with cancer shall be provided with antitumor therapy, radiation and radionuclide therapy, palliative care in cases that do not require constant medical supervision, in organizations providing oncological care at the secondary and tertiary levels in chemotherapy, radiation departments therapy, palliative care, medical rehabilitation. | ||
24 | Availability of hospitalization of a seriously ill patient requiring constant monitoring of vital functions for medical reasons, by decision of the council and notification of the heads of healthcare organizations, with subsequent transfer to another medical organization according to the profile of the disease for further examination and treatment after stabilization of the condition | ||
25 | Availability of examination of severely ill patients by the head of the department on the day of hospitalization, and subsequently - daily. Patients in moderate condition shall be examined at least once a week. The results of the patient's examination shall be recorded in the medical record, indicating recommendations for further tactics of patient management with mandatory identification of the medical worker making the notes | ||
26 | Availability of an established clinical diagnosis together with the head of the department no later than three calendar days from the date of hospitalization of the patient in a healthcare organization | ||
27 |
Availability of daily examination by the attending physician of patients in the hospital except weekends and holidays. When examining and prescribing additional diagnostic and therapeutic procedures by the doctor on duty, appropriate entries shall be made in the medical record. If the patient's condition worsens, the doctor on duty shall notify the head of the department and (or) the attending physician, agree on changes to the diagnostic and treatment process, and make an entry in the medical record (paper and (or) electronic version). | ||
28 | Availability of consultations or council in case of difficulty in identifying the diagnosis, ineffectiveness of the treatment, as well as for other indications | ||
29 |
Availability of examination of persons for clinical indications for HIV infection in identifying the following diseases, syndromes and symptoms: | ||
30 | Availability of an agreement for the provision of paid medical services in healthcare organizations. Availability of documents establishing the fact of co-payment | ||
31 |
Availability of supporting documentation of compliance with discharge criteria, in particular: | ||
32 | Availability of issuing a discharge summary to the patient upon discharge, indicating the full clinical diagnosis, the scope of diagnostic tests performed, treatment measures and recommendations for further observation and treatment. Data on the discharge shall be entered into information systems on the same day, indicating the actual time of discharge. | ||
33 |
Availability of supporting documentation on compliance with the requirements for transfusion of blood components and in case of complications: | ||
34 |
Availability of supporting documentation regarding the determination of the method and tactics of treatment for MDT. | ||
35 | Availability of supporting documentation confirming compliance of the medical care provided with clinical protocols | ||
36 |
Availability of medical documentation on compliance with the following requirements when examining temporary disability, issuing a sheet and certificate of temporary disability (form № 001/у "Medical record of an inpatient", form 052/у "Medical record of an outpatient", stubs of sheets on temporary disability of patients, form № 025/у "Journal for recording the conclusions of the medical consultation commission", form № 029/у "Book of registration of sheets on temporary incapacity for work", form № 037/у "Certificate №__________ on temporary incapacity for work of a student, college student, professional technical school, about illness, quarantine and other reasons for the absence of a child attending school, a preschool organization (underline as necessary)", form № 038/у "Certificate №______ on temporary disability" and others): | ||
37 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical reports) on the conduct of a clinical audit by the Patient Support and Internal Expertise Service and its assessment according to the following criteria: | ||
38 |
Availability of supporting documentation on compliance with the following actions when conducting a pathological autopsy: | ||
39 | Availability of a written statement from a spouse, close relatives or legal representatives of the deceased, or a written expression of will given by a person during his/her lifetime for the release of a corpse without performing a pathological autopsy, in the absence of suspicion of violent death | ||
40 |
Availability of supporting documentation on the provision of oncological care at home: | ||
Official(s)____________________________________ ____________
position signature
_________________________________________________________
surname, first name, patronymic (if any)
Head of the subject of control ____________________ ____________
position signature
_________________________________________________________
surname, first name, patronymic (if any)
Checklist
Footnote. Annex 10 - as amended by the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated 29.05.2003 № 90 and the Minister of National Economy of the Republic of Kazakhstan dated 29.05.2003 № 91 (shall come into effect ten calendar days after the day of its first official publication).
in the field of quality of medical services
___________________________________________________________________
in accordance with Article 138
___________________________________________________________________
of the Entrepreneurial Code of the Republic of Kazakhstan concerning
___________________________________________________________________
subjects (objects) providing medical and social assistance in the field of
mental health
name of a homogeneous group of subjects (objects) of control
___________________________________________________________________
State body that appointed the inspection/preventive control
with a visit to the subject (object) of control
___________________________________________________________________
___________________________________________________________________
Act on the appointment of an inspection/preventive control with a visit to the subject
(object) of control
___________________________________________________________________
____________________________________________________________№, date
Name of the subject (object) of control ____________________________________
____________________________________________________________________
(Individual identification number), business identification number
of the subject (object) of control __________________________________________
____________________________________________________________________
Location address ______________________________________________________
____________________________________________________________________
____________________________________________________________________
№ | List of requirements | Meets requirements | Does not meet requirements |
1 | 2 | 3 | 4 |
Requirements for subjects (objects) providing medical and social assistance in the field of mental health at the outpatient clinic level | |||
1 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | ||
2 |
Availability of supporting documentation on compliance with the criteria for taking persons with mental and behavioural disorders (MBD) for dynamic observation: | ||
3 |
Availability of supporting documentation on compliance with the requirements for drug provision for persons with MBD who are under dynamic observation | ||
4 |
Availability of supporting documentation on compliance with the requirements for deregistration and transfer to another dynamic observation group: | ||
5 |
Availability of supporting documentation on the implementation of the following measures during the dynamic observation of a person with MBD by a psychiatric doctor: | ||
6 |
Availability of an individual treatment plan and rehabilitation program for persons after discharge from an organization providing medical assistance in the field of mental health, except for those discharged by court order as having been cured ahead of schedule. | ||
7 |
Availability of supporting documentation about the provision of primary health care by a doctor, if a person with MBD is suspected or identified, except for MBD requiring the provision of emergency and emergency medical and social care: | ||
8 |
Carrying out the following activities by a psychiatric specialist of the MHC or PMHC if a person with mental health problems is suspected or identified, except for mental health problems requiring the provision of emergency and urgent medical and social care: | ||
9 |
Availability of supporting documentation on the implementation of the following measures by a psychiatric doctor of the MHC or PMHC when applying to a person who was previously on dynamic observation with MBD and was deregistered in the EIS, indicating the reason for the removal, except for "recovery, persistent improvement": | ||
10 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical reports) on the conduct of a clinical audit by the Patient Support and Internal Expertise Service and its assessment according to the following criteria: | ||
Requirements for subjects (objects) providing medical and social assistance in the field of mental health in inpatient conditions, providing for round-the-clock medical supervision | |||
11 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | ||
12 |
Availability of grounds for hospitalization in inpatient clinical departments. | ||
13 |
Completeness of measures taken during planned hospitalization in the inpatient clinical departments of the Republican Scientific and Practical Clinical Hospital, Central Clinical Hospital. | ||
14 |
Completeness of measures taken during hospitalization in the inpatient clinical department of the Republican Scientific and Practical Clinical Hospital, Central Clinical Hospital for emergency indications. | ||
15 |
Completeness of measures taken during planned hospitalization in SPOIS (a specialized psychiatric organization with intensive supervision). | ||
16 |
The completeness of the measures taken after the admission of a person with MBD to the inpatient clinical department. | ||
17 |
Completeness of measures taken after a person’s admission to the inpatient clinical department SPOIS | ||
18 |
Compliance with surveillance regimes. | ||
19 |
Availability of supporting documentation of compliance with the criteria for involuntary hospitalization: | ||
20 |
Availability of supporting documentation of compliance with the conditions of discharge. | ||
21 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical reports) on the conduct of a clinical audit by the Patient Support and Internal Expertise Service and its assessment according to the following criteria: | ||
Requirements for subjects (objects) providing medical and social assistance in the field of mental health in inpatient conditions that do not require round-the-clock medical supervision and treatment and provide for medical supervision and treatment during the day with the provision of a bed | |||
22 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | ||
23 |
Availability of indications for treatment in inpatient conditions for persons with MBD | ||
24 |
Carrying out the following activities during hospitalization in a day hospital: | ||
25 |
Requirements for the duration of treatment and time of stay in a day hospital. | ||
26 |
Compliance with requirements for discharge from day hospital. | ||
27 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical reports) on the conduct of a clinical audit by the Patient Support and Internal Expertise Service and its assessment according to the following criteria: | ||
Requirements for entities (objects) providing medical and social assistance to persons with mental and behavioural disorders (diseases) in the form of emergency medical and social assistance | |||
28 | The provision of emergency specialized psychiatric care shall be carried out by specialized teams organized as part of an organization providing emergency medical and social care or EMS. | ||
Requirements for subjects (objects) providing medical and social rehabilitation in the field of mental health | |||
29 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | ||
30 |
Availability of supporting documentation of compliance with the requirements for medical and social rehabilitation in outpatient or inpatient settings. | ||
31 |
Availability of supporting documentation of compliance with the requirements for medical and social rehabilitation in inpatient settings. | ||
32 |
Availability of supporting documentation for the activities of the multidisciplinary group. | ||
33 |
Requirements for the duration of medical and social rehabilitation. | ||
Requirements for subjects (objects) conducting a medical examination to establish the fact of use of a psychoactive substance and state of intoxication | |||
34 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | ||
35 |
Availability of supporting documentation confirming compliance with the requirements for identifying a person sent or coming for a medical examination. | ||
36 |
Availability of supporting documentation on compliance with the requirements for examination of foreign citizens and minor citizens of the Republic of Kazakhstan. Foreign citizens permanently residing and temporarily staying on the territory of the Republic of Kazakhstan, as well as stateless persons who are intoxicated in a public place, at work, or driving a vehicle, are subject to a medical examination on a general basis. | ||
37 |
Availability of supporting documentation of compliance with the requirements for medical examination of persons delivered in a severe unconscious state. | ||
38 |
Availability of supporting documentation on compliance with the requirements for the conditions of laboratory research or rapid testing of biological media. | ||
39 |
Availability of supporting documentation of compliance with the requirements for laboratory research or rapid testing of biological media. | ||
40 |
Availability of supporting documentation of compliance with the requirements for conducting a quantitative test of exhaled air for alcohol. | ||
41 |
Availability of supporting documentation of compliance with the requirements for registration of refusal of medical examination | ||
42 |
Availability of supporting documentation on compliance with the requirements for establishing the condition of the person being examined. | ||
43 |
Availability of supporting documentation of compliance with the requirements for drawing up the Medical Examination Report. | ||
44 |
Availability of supporting documentation of compliance with the requirements for repeated medical examination. | ||
Requirements for subjects (objects) providing temporary adaptation and detoxification | |||
45 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | ||
46 |
Availability of supporting documentation on compliance with the requirements for organizing the activities of the temporary adaptation and detoxification centre: | ||
47 |
Identification by employees of the internal affairs bodies of the person delivered and notification to the medical personnel of the Central Military District. | ||
48 |
Registration of a person admitted with suspicion of alcohol intoxication in the register of admissions and refusals to hospitalization according to the approved form | ||
49 |
The results of the medical examination shall be documented in the conclusion of the medical examination conducted at the Central Medical Examination Centre (hereinafter referred to as the Conclusion) in the approved form | ||
50 |
Registration by medical personnel of personal belongings, documents, money and other valuables in the journal for registering documents and personal belongings of patients according to the form before placing the patient in the TADT. | ||
51 | Availability of a card placed in the TADT, located in the centre of temporary adaptation and detoxification (hereinafter referred to as the Patient’s card). If there are medical indications, treatment shall be prescribed. The doctor's prescriptions shall be entered into the patient's chart. The frequency of medical examinations shall depend on the patient’s condition. | ||
52 | The patient shall be discharged by a psychiatrist (narcologist) as planned when an improvement in condition is achieved that does not require further observation and treatment in a TADT within 24 (twenty-four) hours from the date of admission. Upon discharge, a corresponding entry shall be made in the patient’s chart and the log of admissions and refusals of hospitalization. | ||
53 | Written confirmation from the patient that upon receipt of his/her documents and personal belongings, all documents and personal belongings were received in accordance with the entry in the register of documents and personal belongings of patients, except for things the storage of which is illegal. | ||
Requirements for subjects (objects) providing medical examination and gender reassignment for persons with gender identity disorders | |||
54 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | ||
55 |
Availability of supporting documentation of compliance with the requirement to conduct a medical examination of persons with gender identity disorders for gender reassignment: | ||
56 | Referral by a psychiatrist of the person being examined, if there are doubts about the mental state, for an inpatient examination at a medical organization | ||
57 |
Referral of the person being examined by a psychiatrist, in the absence of MBD, which are contraindications for gender reassignment, to the clinic at the place of residence for a medical examination | ||
Official(s)____________________________________ ____________
position signature
_________________________________________________________
surname, first name, patronymic (if any)
Head of the subject of control ____________________ ____________
position signature
_________________________________________________________
surname, first name, patronymic (if any)
Checklist
Footnote. Annex 11 - as amended by the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated 29.05.2003 № 90 and the Minister of National Economy of the Republic of Kazakhstan dated 29.05.2003 № 91 (shall be enforced upon the expiration of ten calendar days after the day of its first official publication).
in the field of quality of medical services
_______________________________________________________________
in accordance with Article 138
_______________________________________________________________
of the Entrepreneurial Code of the Republic of Kazakhstan concerning
_______________________________________________________________
subjects (objects) providing laboratory services
name of a homogeneous group of subjects (objects) of control
_______________________________________________________________
State body that appointed inspection/preventive control
with a visit to the subject (object) of control
_______________________________________________________________
_______________________________________________________________
Act on the appointment of an inspection/preventive control with a visit to the subject
(object) of control
_______________________________________________________________
_______________________________________________________________ №, date
Name of the subject (object) of control _______________________________
_______________________________________________________________
(Individual identification number), business identification
number of the subject (object) of control
_______________________________________________________________
_______________________________________________________________
Location address
_______________________________________________________________
_______________________________________________________________
№ | List of requirements | Meets requirements | Does not meet requirements |
1 | 2 | 3 | 4 |
1 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | ||
2 | Availability of written voluntary consent of the patient or his/her legal representative for invasive interventions and for carrying out therapeutic and diagnostic measures | ||
3 | The presence of a biosafety specialist among the personnel of the laboratory (if the laboratory personnel has more than twenty full-time positions) | ||
4 | Availability of portable test strip analyzers in primary health care organizations | ||
5 |
The presence at the hospital level in healthcare organizations as part of a consultative and diagnostic laboratory (hereinafter referred to as the CDL) of an additional unit created or a separate express laboratory at intensive care units to perform emergency and emergency laboratory tests in the shortest possible time from taking a sample to reporting the result (within 15- 60 minutes). | ||
6 | Implementation of processes for managing the quality of clinical laboratory research according to the principle of stages, which shall include pre-analytical, analytical and post-analytical stages of laboratory research | ||
7 | Use of certified and registered in the Republic of Kazakhstan equipment, diagnostic reagent kits, test systems and consumables to perform research | ||
8 | Availability of a laboratory information system | ||
9 | Conducting internal laboratory quality control of research | ||
10 | Compliance with triple packaging and temperature conditions when transporting biomaterial, including by road, air and rail | ||
11 | Availability of supporting documentation on compliance with the algorithm for analytical quality control in laboratory diagnostics | ||
12 | Availability of an agreement for the provision of paid medical services in healthcare organizations. Availability of documents establishing the fact of co-payment | ||
13 | Availability of supporting documentation on the competence and quality of laboratory diagnostics | ||
14 | Documentation of laboratory diagnostics |
Official(s)____________________________________ ____________
position signature
_________________________________________________________
surname, first name, patronymic (if any)
Head of the subject of control ______________________ __________
position signature
_________________________________________________________
surname, first name, patronymic (if any)
| Annex 12 to the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated November 15, 2018 № KR DSM-32 and the Minister of National Economy of the Republic of Kazakhstan dated November 15, 2018 № 70 |
Checklist
Footnote. Annex 12 - as amended by the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated 29.05.2003 № 90 and the Minister of National Economy of the Republic of Kazakhstan dated 29.05.2003 № 91 (shall come into effect ten calendar days after the day of its first official publication).
in the field of quality of medical services
__________________________________________________________________
in accordance with Article 138
__________________________________________________________________
of the Entrepreneurial Code of the Republic of Kazakhstan concerning
__________________________________________________________________
subjects (objects) providing emergency medical care and medical
care in the form of medical aviation name of a homogeneous group of subjects
(objects) of control
__________________________________________________________________
State body that appointed the inspection/preventive control
with a visit to the subject (object) of control
__________________________________________________________________
__________________________________________________________________
Act on the appointment of an inspection/preventive control with a visit to the subject
(object) of control
__________________________________________________________________
____________________________________________________________ №, date
Name of the subject (object) of control __________________________________
__________________________________________________________________
(Individual identification number), business identification number
of the subject (object) of control ________________________________________
__________________________________________________________________
Location address ____________________________________________________
__________________________________________________________________
__________________________________________________________________
№ | List of requirements | Meets requirements | Does not meet requirements |
1 | 2 | 3 | 4 |
General requirements | |||
1 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | ||
2 | Availability of supporting documentation on the compliance of the treatment and diagnostic measures carried out with the recommendations of clinical protocols | ||
3 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical reports) on the conduct of a clinical audit by the Patient Support and Internal Expertise Service and its assessment according to the following criteria: | ||
For emergency medical services | |||
4 | Equipping ambulance vehicles with radio communications and navigation systems | ||
5 | The presence in the emergency medical service of regions, cities of republican significance and the capital of an automated control system for receiving and processing calls and systems that allow monitoring of ambulance vehicles through navigation systems, as well as a system for computer recording of dialogues with subscribers and an automatic identification of the telephone number from which a call comes in. Dialogue recordings shall be stored for at least 2 years. | ||
6 | Availability of regional Call centres (call centres) as part of regional emergency medical care stations and emergency medical care stations in cities of republican significance and the capital | ||
7 | Compliance with a five-minute processing time for an emergency medical call from the moment it is received by the dispatcher, during which sorting shall be carried out according to the category of urgency of the call. | ||
8 | Compliance with the time of arrival of the emergency team to the patient’s location from the moment of receiving a call from the dispatcher according to the list of categories of urgency of emergency medical calls (from 10 minutes to 60 minutes) | ||
9 |
Correct determination by the emergency medical service dispatcher of calls by urgency category according to: | ||
10 |
The paramedic or doctor of the emergency medical service team or emergency medical service department when organizing primary health care shall make one of the following decisions based on the results of examination, instrumental diagnostics, the dynamics of the patient’s condition against the background or after the treatment measures taken, in accordance with the preliminary diagnosis reflecting the causes of this condition: | ||
11 | Availability of medical recommendations for further contact with the primary health care organization (at the place of residence or attachment in the case of leaving a patient who does not need hospitalization at the place of call or home, the emergency medical service team or the emergency medical service department at the primary health care organization shall be provided | ||
12 | Availability of a signal sheet for the patient in case the patient becomes ill and needs to be visited at home by a local doctor | ||
13 |
Availability of recording the following data when a call is received by the dispatch service of the emergency medical service station: | ||
14 |
Compliance with the time of arrival of paramedics and specialized (medical) teams to the patient’s location from the moment of receiving a call from the emergency medical station dispatcher, taking into account the category of urgency: | ||
15 | Availability of informing the emergency medical service dispatcher of the hospital admission department about the delivery of the patient in the event of a decision by the emergency medical service team or the emergency medical service department when organizing primary health care to transport the patient to the hospital | ||
16 | Availability of a minimum list of medical devices for ambulance transport of an ambulance station in classes A, B and C | ||
For medical assistance in the form of air ambulance | |||
17 | Availability of an assignment for a medical flight in form № 090/у | ||
18 | Availability of supporting documentation about the mobile medical aviation team conducting an ongoing assessment of the condition and treatment of the patient(s) when transporting the patient (s) according to the relevant clinical protocols for diagnosis and treatment | ||
19 | Availability of grounds for the provision of medical care in the form of medical aviation (extract from the medical record of a patient in need of medical care in the form of medical aviation; application from the coordinating doctor of the medical aviation department to the dispatcher of the Coordinating organization; in emergency cases, an oral order from the authorized body, with written confirmation; call from the ambulance service and other emergency services) | ||
20 | Availability of approval by the dispatcher of the Coordinating organization of the composition of the mobile medical aviation team and the involved qualified specialized expert(s) from medical organizations in the region with obtaining their informed consent | ||
21 | Availability of a schedule of qualified specialists in the provision of medical care in the form of medical aviation approved by healthcare entities and medical education organizations in the Coordinating Organization | ||
22 |
Availability of informed consent of the patient(s) for the provision of medical care in the form of medical aviation during its transportation. | ||
Official(s)____________________________________ ____________
position signature
_________________________________________________________
surname, first name, patronymic (if any)
Head of the subject of control ____________________ ____________
position signature
_________________________________________________________
surname, first name, patronymic (if any)
Checklist
Footnote. Annex 13 - as amended by the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated 29.05.2003 № 90 and the Minister of National Economy of the Republic of Kazakhstan dated 29.05.2003 № 91 (shall come into effect ten calendar days after the day of its first official publication).
in the field of quality of medical services
____________________________________________________________________
in accordance with Article 138
____________________________________________________________________
of the Entrepreneurial Code of the Republic of Kazakhstan concerning
____________________________________________________________________
subjects (objects) carrying out activities in the field of
HIV prevention name of a homogeneous group of subjects (objects) of control
____________________________________________________________________
State body that appointed the inspection/preventive control
with a visit to the subject (object) of control
____________________________________________________________________
Act on the appointment of an inspection/preventive control with a visit to the subject
(object) of control
____________________________________________________________________
______________________________________________________________№, date
Name of the subject (object) of control _____________________________________
_____________________________________________________________________
(Individual identification number), business identification number
of the subject (object) of control __________________________________________
____________________________________________________________________
Location address ______________________________________________________
_____________________________________________________________________
_____________________________________________________________________
№ | List of requirements | Meets requirements | Does not meet requirements |
1 | 2 | 3 | 4 |
1 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | ||
2 |
Conducting an examination using the rapid testing method with registration in the HIV research journal using the express testing method. | ||
3 | Availability of a written notification from a health care organization that, during a medical examination, revealed the fact of HIV infection in the subject about the result obtained, about the need to take precautions aimed at protecting one’s health and the health of others, as well as a warning about administrative and criminal liability for evading treatment and infecting others persons with the patient signing a confidential interview sheet with a person infected with HIV in accordance with form № 095/у | ||
4 |
Availability of supporting documentation on compliance with the deadlines for issuing negative results. | ||
5 |
Availability of supporting documentation on compliance with the deadlines for sending serum samples to the republican state health care organization. | ||
6 |
Availability of supporting documentation on compliance with the deadlines for re-examination in case of doubtful results. | ||
7 |
Availability of pre-test and post-test counselling. | ||
8 | Sending by a health care organization operating in the field of HIV prevention to the territorial state body in the field of sanitary and epidemiological welfare an emergency notification in form № 034/у for each case of HIV infection allegedly associated with the provision of medical care (in-hospital) | ||
9 |
Availability of a Sheet for a confidential interview with a person infected with HIV, Form № 095/у, which shall include: consent to enter personal data into electronic | ||
10 | Monitoring and assessment of the coverage of key population groups and people living with HIV infection shall be carried out by maintaining a database of individual records of clients and appropriate forms of accounting and reporting documentation by specialists of health care organizations carrying out activities in the field of HIV prevention | ||
11 | Transfer by the employer of medical workers with an established diagnosis of HIV infection to another job that does not involve violating the integrity of the skin or mucous membranes | ||
12 |
Availability of supporting documentation on the diagnosis and treatment of STIs. | ||
13 | Availability of equipped transport for mobile trust points | ||
14 | Availability of supporting documentation on the implementation of pre-exposure and post-exposure prophylaxis among the population and key populations | ||
15 |
Availability of monitoring contacts on time. | ||
16 |
Availability of dynamic monitoring and provision of antiretroviral therapy for HIV-infected persons. | ||
17 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical reports) on the conduct of a clinical audit by the Patient Support and Internal Expertise Service and its assessment according to the following criteria: |
Official(s)____________________________________ ____________
position signature
_________________________________________________________
surname, first name, patronymic (if any)
Head of the subject of control ____________________ ____________
position signature
_________________________________________________________
surname, first name, patronymic (if any)
Checklist
Footnote. Appendix 14 - as amended by the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated 29/05/2023 № 90 and the Minister of National Economy of the Republic of Kazakhstan dated 05/29/2023 № 91 (shall come into effect upon the expiration of ten calendar days after the day of its first official publication).
in the field of quality of medical services
___________________________________________________________________
in accordance with Article 138
___________________________________________________________________
of the Entrepreneurial Code of the Republic of Kazakhstan concerning
___________________________________________________________________
subjects (objects) operating in the field of blood service
name of a homogeneous group of subjects (objects) of control
___________________________________________________________________
State body that appointed the inspection/preventive control
with a visit subject (object) of control
___________________________________________________________________
___________________________________________________________________
Act on the appointment of an inspection/preventive control with a visit to the subject
(object) of control
_____________________________________________________________________
____________________________________________________________ №, date
Name of the subject (object) of control ________________________________________
_____________________________________________________________________
(Individual identification number), business identification number
of the subject (object) of control __________________________________________
____________________________________________________________________
Location address ______________________________________________________
____________________________________________________________________
____________________________________________________________________
№ | List of requirements | Meets requirements | Does not meet requirements |
1 | 2 | 3 | 4 |
1 | Availability of supporting documentation on the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social health insurance on a free basis | ||
2 | Availability of supporting documentation on compliance in the organization of the blood service with the requirements for step-by-step labelling of blood and its components. Providing conditions for traceability of the movement of each blood product from the donor to the receipt of the finished product and its use | ||
3 | Availability of supporting documentation confirming compliance with the requirements for laboratory testing of the recipient's blood samples for the availability of markers of blood-borne infections before and after transfusions carried out using high-quality immunoserological and molecular biological methods on closed-type automatic analyzers. | ||
4 | Availability of registration in the electronic information database after the donation of blood and its components of all information about the donation of blood and its components, including the type of reaction and volume of medical care provided, in case of side effects of donation, compliance of documents for transfer to the primary fractionation unit with accompanying documentation collected blood and its components | ||
5 | Availability of blood and its components donor questionnaire provided to the donor, which he/she fills out independently or with the participation of a medical registrar, as well as an information sheet | ||
6 | Availability of supporting documentation on compliance with the requirements for performing immunohematological studies for the availability of irregular anti-erythrocyte antibodies in liquid-phase systems on a plane and in test tubes, reading the result of an agglutination reaction with mandatory microscopy. | ||
7 |
Availability of supporting documentation on compliance with the requirements for incoming and daily in-laboratory quality control of reagents to confirm their activity and specificity. The following shall be subject to incoming control: | ||
8 | Placement of blood collected on-site in thermal containers marked "Unexamined blood products, not subject to issue" and at a temperature of 22±2°C shall be delivered within 18-24 hours to the blood service organization | ||
9 | Use of reagents with monoclonal antibodies and equipment registered by the state body in the field of circulation of medicines and medical devices for immunohematological studies of blood samples of potential recipients | ||
10 | Availability of supporting documentation on compliance with the requirements of blood transfusion and its components | ||
11 | Availability of supporting documentation on compliance with the requirements for the donor to undergo a mandatory medical examination before donating blood and its components within the framework of the guaranteed volume of free medical care | ||
12 | Compliance with requirements for medical examination of donors, safety and quality in the production of blood products for medical use | ||
13 | Availability of supporting documentation on compliance with the requirements of external assessment of the quality of laboratory research measurements in reference laboratories | ||
14 | Compliance with the requirements for incoming and daily in-laboratory quality control of reagents to confirm their activity and specificity. | ||
15 | Availability of a blood donor and its components questionnaire provided to the donor, which he/she fills out independently or with the participation of a medical registrar. | ||
16 |
The following shall be subject to incoming control: | ||
17 | Compliance with requirements for medical examination of donors, safety and quality in the production of blood products for medical use | ||
18 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical reports) on the conduct of a clinical audit by the Patient Support and Internal Expertise Service and its assessment according to the following criteria: |
Official(s)____________________________________ ____________
position signature
_________________________________________________________
surname, first name, patronymic (if any)
Head of the subject of control ____________________ ____________
position signature
_________________________________________________________
surname, first name, patronymic (if any)
| Appendix 15 to the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated November 15, 2018 № KR HCM-32 and the Minister of National Economy of the Republic of Kazakhstan dated November 15, 2018 № 70 |
Criteria for assessing the degree of risk in the sphere of circulation of medicines and medical devices Chapter 1. General provisions
1. These Criteria for assessing the degree of risks in the sphere of circulation of medicines and medical devices (hereinafter - the Criteria) have been developed in accordance with subparagraph 16) of Article 10 of the Code of the Republic of Kazakhstan “On Public Health and Healthcare System”, paragraphs 5 and 6 of Article 141 and paragraph 1 Article 143 of the Entrepreneurial Code of the Republic of Kazakhstan, the Rules for the formation of risks assessment and management system by regulatory state bodies, approved by order of the acting Minister of National Economy of the Republic of Kazakhstan dated June 22, 2022 № 48 (registered in the Register of state registration of regulatory legal acts under № 28577) and by order of the acting Minister of National Economy of the Republic of Kazakhstan dated July 31, 2018 № 3 “On approval of the checklist’s form” (registered in the Register of state registration of regulatory legal acts under № 17371).
2. The following concepts are used in these Criteria:
1) a point – a quantitative measure of risk calculation;
2) data normalization – a statistical procedure that involves bringing values measured on various scales to a conventionally common scale;
3) risk - the probability of causing harm as a result of the activities of the subject of control of human life or health, the environment, the legitimate interests of individuals and legal entities, the property interests of the state, taking into account the severity of its consequences;
4) risks assessment and management system - the process of making management decisions aimed at reducing the probability of adverse factors occurring by distributing subjects (objects) of control according to risk levels for subsequent implementation of preventive control with a visit to the subject (object) of control and (or) inspections conducted for compliance with qualification or permitting requirements for issued permits, requirements for sent notifications in accordance with the Law of the Republic of Kazakhstan “On Permits and Notifications” (hereinafter - verification of compliance with the requirements) in order to limit the freedom of entrepreneurship to the minimum possible extent, while ensuring an acceptable level of risk in the relevant areas of activity, as well as those aimed at changing the level of risk for a specific subject (object) of control and (or) exemption of such subject (object) of control from preventive control with a visit to the subject (object) of control and (or) inspections for compliance with requirements;
5) objective criteria for assessing the degree of risk (hereinafter - objective criteria) - criteria for assessing the degree of risk used to select subjects (objects) of control depending on the degree of risk in a certain field of activity and not directly dependent on the individual subject (object) of control;
6) criteria for assessing the degree of risk - a set of quantitative and qualitative indicators related to the direct activities of the subject of control, features of industry development and factors influencing this development, allowing the subjects (objects) of control to be assigned to various degrees of risk;
7) subjective criteria for assessing the degree of risk (hereinafter - subjective criteria) - criteria for assessing the degree of risk used for selecting subjects (objects) of control and depending on the results of the activities of a particular subject (object) of control;
8) a checklist - a list of requirements for the activities of subjects (objects) of control, non-compliance with which entails a threat to human life and health, the environment, the legitimate interests of individuals and legal entities, the state;
9) sample set (sample) – a list of assessed subjects (objects) classified as a homogeneous group of subjects (objects) of control in a specific area of state control, in accordance with paragraph 2 of Article 143 of the Entrepreneurial Code of the Republic of Kazakhstan.
Chapter 2.
The procedure for forming risks assessment and management system
when conducting preventive control of subjects (objects) of control
3. Risks management when carrying out preventive control with a visit to the subject (object) of control shall be formed by determining objective and subjective criteria, which are carried out in stages (multi-criteria analysis of decisions).
At the first stage, according to objective criteria, subjects (objects) of control are distributed to one of the following degrees of risk:
1) high risk;
2) medium risk;
3) low risk.
According to the indicators of the degree of risk according to subjective criteria, the subject (object) of control refers:
1) to a high degree of risk - with a risk degree indicator from 71 to 100 inclusive;
2) to an average degree of risk - with a risk degree indicator from 31 to 70 inclusive;
3) to a low degree of risk - with a risk degree indicator from 0 to 30 inclusive.
4. Criteria for assessing the degree of risk for conducting preventive control of subjects (objects) of control shall be formed by defining objective and subjective criteria.
Paragraph 1. Objective criteria
5. Determination of risk according to objective criteria shall be carried out depending on the specifics of the area in which state control is carried out, taking into account one of the following criteria:
1) level of danger (complexity) of the object;
2) the scale of severity of possible negative consequences, harm to the regulated area (region);
3) the possibility of an unfavorable incident for human life or health, the legitimate interests of individuals and legal entities, and the state.
6. After analyzing possible risks, subjects (objects) of control shall be distributed into three degrees of risk according to objective criteria (high, medium and low).
7. A high degree of risk includes subjects (objects) of control carrying out activities related to:
1) production of medicines;
2) manufacturing of medicines;
3) wholesale sales of medicines;
4) production of medical devices;
5) manufacturing of medical devices;
8. A medium degree of risk includes subjects (objects) of control:
1) subjects in the field of circulation of medicines and medical devices that carry out retail sales of medicines;
2) healthcare organizations providing outpatient care;
3) healthcare organizations providing inpatient care and (or) inpatient replacing care;
4) healthcare organizations providing emergency medical care and (or) air ambulance services;
5) healthcare organizations engaged in the procurement, preservation, processing, storage, and sale of blood and its components.
9. A low degree of risk includes subjects (objects) of control:
1) subjects in the field of circulation of medicines and medical devices carrying out retail sales of medicines and having a certificate of good pharmacy practice (GPP);
2) subjects (objects) of control carrying out pharmaceutical activities related to the wholesale and retail sale of medical devices.
10. For subjects (objects) of control classified as high and medium degree of risk according to objective criteria, an inspection for compliance with requirements, preventive control with a visit to the subject (object) of control, preventive control without a visit to the subject (object) of control and an unscheduled inspection shall be conducted.
11. For areas of activity of subjects (objects) of control classified as low degree of risk according to objective criteria, an inspection for compliance with the requirements of preventive control without a visit to the subject (object) of control and an unscheduled inspection shall be conducted.
Paragraph 2. Subjective criteria
12. The determination of subjective criteria in the field of circulation of medicines and medical devices shall be carried out using the following stages:
1) formation of a database and collection of information;
2) analysis of information and risks assessment.
13. Formation of a database and collection of information are necessary to identify subjects (objects) of control.
The following sources of information shall be used to assess the degree of risk:
1) the results of previous inspections and preventive control with visits to subjects (objects) of control;
2) Note of the ILLI!Subparagraph 2) shall be enforced from 01.12.2024 by joint order of the acting Minister of Healthcare of the Republic of Kazakhstan dated 24.05.2023 № 87 and Minister of National Economy of the Republic of Kazakhstan dated 24.05.2023 № 77.
3) Note the ILLI!
Subparagraph 3) shall be enforced from 01.12.2024 by joint order of the acting Minister of Healthcare of the Republic of Kazakhstan dated 24.05.2023 № 87 and Minister of National Economy of the Republic of Kazakhstan dated 24.05.2023 № 77.
4) Note of the ILLI!
Subparagraph 4) shall be enforced from 01.12.2024 by joint order of the acting Minister of Healthcare of the Republic of Kazakhstan dated 24.05.2023 № 87 and Minister of National Economy of the Republic of Kazakhstan dated 24.05.2023 № 77.
5) Note of the ILLI!
Subparagraph 5) shall be enforced from 01.12.2024 by joint order of the acting Minister of Healthcare of the Republic of Kazakhstan dated 24.05.2023 № 87 and Minister of National Economy of the Republic of Kazakhstan dated 24.05.2023 № 77.
The following sources of information shall be used to assess the degree of risk when creating a schedule for requirements compliance:
1) the results of previous inspections and preventive control with visits to subjects (objects) of control;
2) the presence of adverse incidents that arose through the fault of the subject of control;
3) the presence and number of confirmed complaints and appeals;
4) results of preventive control without a visit to the subject (object) of control (final documents issued based on the results of preventive control without a visit to the subject (object) of control);
14. Based on available sources of information, data according to subjective criteria, subject to analysis and assessment shall be formed.
Analysis and assessment of subjective criteria allow us to concentrate the conduct of inspection for compliance with requirements and preventive control of the subject (object) of control in relation to the subject (object) of control with the greatest potential risk.
At the same time, the data of subjective criteria previously taken into account and used in relation to a specific subject (object) of control or data for which the statute of limitations has expired in accordance with the legislation of the Republic of Kazakhstan shall not be used in the analysis and assessment.
In relation to subjects of control who have fully eliminated the violations issued based on the results of the previous preventive control with a visit and (or) inspection for compliance with the requirements, their inclusion in the formation of schedules and lists for the next period of state control shall not be allowed.
15. The degree of violations of requirements for subjects (objects) of control in the field of circulation of medicines and medical devices for compliance with qualification requirements shall be determined in accordance with Appendix 1 to these Criteria and the Degree of violation of requirements for subjects (objects) of control in the field of circulation of medicines and medical devices for conducting preventive control of subjects (objects) of control by information sources shall be determined in accordance with Appendix 2 to these Criteria.
16. Based on the priority of the sources of information used and the significance of indicators of the subjective criteria, in accordance with the procedure for calculating the risk degree indicator according to subjective criteria determined in the List of subjective criteria for determining the degree of risk according to subjective criteria in the field of circulation of medicines and medical devices in accordance with Article 138 of the Entrepreneurial Code of the Republic of Kazakhstan in relation to all subjects (objects) in accordance with Appendix 3 to these Criteria, the risk degree indicator shall be calculated according to subjective criteria.
17. Inspection for compliance with requirements and preventive control with a visit to the subject (object) shall be carried out depending on the purpose and types of activity of the objects, in accordance with checklists in the field of circulation of medicines and medical devices according to Appendices 16, 17, 18, 19, 20, 21 and 25 to this joint order.
18. For areas of activity of subjects (objects) of control classified as high-risk, inspections for compliance with requirements shall be determined by criteria, but shall be carried out no more than once a year.
For areas of activity of subjects (objects) of control classified as medium risk, inspections for compliance with requirements shall be determined by criteria, but shall be carried out no more than once every two years.
For areas of activity of subjects (objects) of control classified as low risk, the frequency of inspections for compliance with requirements shall be determined by criteria for assessing the degree of risk, but not more than once every three years.
Chapter 3. The procedure for calculating the degree of risk according to subjective criteria
19. The calculation of the risk degree indicator according to subjective criteria (R) shall be carried out in an automated mode by summing up the risk degree indicator for violations based on the results of previous inspections and preventive control with visits to subjects (objects) of control (SP) and the risk degree indicator according to subjective criteria determined in accordance with paragraph 13 of these Criteria (SC), with subsequent normalization of the values given in the range from 0 to 100 points.
Rinterm = SP + SC, where
Rinterm - an intermediate indicator of the degree of risk according to subjective criteria,
SP – an indicator of the degree of risk for violations,
SC - an indicator of the degree of risk according to subjective criteria determined in accordance with paragraph 13 of these Criteria.
The calculation shall be made for each subject (object) of control of a homogeneous group of subjects (objects) of control of each sphere of state control. In this case, the list of assessed subjects (objects) of control, classified as a homogeneous group of subjects (objects) of control of one sphere of state control shall form a sample set (sample) for subsequent normalization of data.
20. Based on the data obtained from the results of previous inspections and preventive control with visits to subjects (objects) of control, an indicator of the degree of risk for violations shall be formed, assessed in points from 0 to 100.
If one gross violation is detected from any of the sources of information specified in paragraph 16 of these Criteria, the subject of control shall be assigned a risk indicator of 100 points and shall be subject to inspection for requirements compliance or preventive control with a visit to the subject (object) of control.
SРн – показатель незначительных нарушений;
If gross violations are not detected, the risk level indicator for violations shall be calculated by the total indicator for violations of a significant and minor degree.
When determining the indicator of significant violations, a coefficient of 0.7 shall be applied.
This indicator shall be calculated using the following formula:
SРs = (SР2 х 100/SР1) х 0,7, where:
SPs – an indicator of significant violations;
SР1 – required number of significant violations;
SР2 – number of significant violations identified;
When determining the indicator of minor violations, a coefficient of 0.3 shall be applied.
This indicator shall be calculated using the following formula:
SРm = (SР2 х 100/SР1) х 0,3, where:
SРm – an indicator of minor violations;
SР1 – required number of minor violations;
SР2 – number of minor violations identified;
The violation risk indicator (SP) shall be calculated on a scale from 0 to 100 points and shall be determined by summing the indicators of significant and minor violations according to the following formula:
SР = SРs + SРm, where:
SP – an indicator of the risk degree for violations;
SPs – an indicator of significant violations;
SРm - an indicator of minor violations.
The resulting value of the risk degree indicator for violations shall be included in the calculation of the risk degree indicator based on subjective criteria.
21. The calculation of the risk degree indicator according to subjective criteria determined in accordance with paragraph 16 of these Criteria shall be made on a scale from 0 to 100 points and shall be carried out using the following formula:
xi – an indicator of subjective criterion,
wi – specific weight of the subjective criterion indicator xi,
n – number of indicators.
The resulting value of the risk degree indicator according to subjective criteria, determined in accordance with paragraph 13 of these Criteria, shall be included in the calculation of the risk degree indicator according to subjective criteria.
22. The R indicator values calculated for subjects (objects) shall be normalized to a range from 0 to 100 points. Data normalization shall be carried out for each sample set (sample) using the following formula:
R – risk degree indicator (final) according to the subjective criteria of an individual subject (object) of control,
Rmax – the maximum possible value on the risk degree scale according to subjective criteria for subjects (objects) included in one sample set (sample) (upper limit of the scale),
Rmin – the minimum possible value on the risk degree scale according to subjective criteria for subjects (objects) included in one sample set (sample) (lower limit of the scale),
Rinterm - an intermediate indicator of the degree of risk according to subjective criteria, calculated in accordance with paragraph 16 of these Criteria.
| Appendix 1 to the criteria for assessing the degree of risk in the area of circulation of medicines and medical devices |
The degree of violation of requirements for subjects (objects) of control in the sphere
of circulation of medicines and medical devices for compliance with qualification requirements
| Appendix 2 to the criteria for assessing the degree of risk in the area of circulation of medicines and medical devices |
The degree of violation of requirements for subjects (objects) of control in the sphere of circulation of medicines and medical devices for conducting preventive control of subjects (objects) of control by information sources
| Appendix 3 to the criteria for assessment the degree of risk in the area of circulation medicines and medical devices |
List of subjective criteria for determining the degree of risk according to subjective criteria in the field
of circulation of medicines and medical devices in accordance with Article 138 of the Entrepreneurial
Code of the Republic of Kazakhstan in relation to all subjects (objects)
Checklist in the field of circulation of medicines and medical devices for
compliance with qualification requirements for subjects (objects) of control
Footnote. Appendix 16 is in the wording of the joint order of the acting Minister of Healthcare of the Republic of Kazakhstan dated 24.05.2023 № 87 and the Minister of National Economy of the Republic of Kazakhstan dated 24.05.2023 № 77 (shall be enforced upon expiry of ten calendar days after the day of its first official publication).
The state body that appointed an inspection/preventive control with a visit
to the subject (object) of control
_______________________________________________________
__________________________________________________________________________
An act on the appointment of an inspection/preventive control with a visit to the subject
(object)
of control
_______________________________________________________________________
__________________________________________________________________________
№, date
Name of the subject (object) of control
__________________________________________________________________________
(Individual identification number), the business identification number of the subject (object)
of control
______________________________________________________________
Location address
__________________________________________________________________________
Official(s)
_________________________________________________________________________
position signature
__________________________________________________________________________
surname, name, patronymic (if any)
Head of the subject of control
__________________________________________________________________________
position signature
__________________________________________________________________________
surname, name, patronymic (if any)
Checklist in the field of circulation of medicines and medical devices in relation to medical organizations on drug supply issues
Footnote. Appendix 17 – as amended by the joint order of the Acting Minister of Healthcare of the Republic of Kazakhstan dated 24.05.2023 №87 and the Minister of National Economy of the Republic of Kazakhstan dated 24.05.2023 № 77 (effective ten calendar days after the date of its first official publication).
State body that appointed inspection/preventive control with a visit to the
control subject (object) _______________________________________________________
__________________________________________________________________________
Act on appointing inspection / preventive control with a visit to the
control subject (object)
_____________________________________________________________
__________________________________________________________________________
№, date
Name of the control subject (object)
__________________________________________________________________________
(Individual Identification Number), Business Identification Number of the
control subject (object)
_______________________________________________________________
Location address
Designated person (s)
_______________________________________________________________________________
position, signature
________________________________________________________________________________
surname, name, patronymic (if any)
The head of the control subject
__________________________________________________________________________
position, signature
__________________________________________________________________________
surname, name, patronymic (if any)
| Appendix 18 to the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated November 15, 2018 № ҚР ДСМ-32 and the Minister of National Economy of the Republic of Kazakhstan dated November 15, 2018 №70 |
Checklist in the field of circulation of medicines and medical devices regarding subjects (objects)
of pharmaceutical activities engaged in the production of medicines and medical devices
Footnote. Appendix 18 – as amended by the joint order of the Acting Minister of Healthcare of the Republic of Kazakhstan dated 24.05.2023 №87 and the Minister of National Economy of the Republic of Kazakhstan dated 24.05.2023 № 77 (effective ten calendar days after the date of its first official publication).
State body that appointed inspection/preventive control with a visit to the
control subject (object) _______________________________________________________
__________________________________________________________________________
Act on appointing inspection / preventive control with a visit to
control subject (object)
_____________________________________________________________
__________________________________________________________________________
№, date
Name of the control subject (object)
__________________________________________________________________________
(Individual Identification Number), Business Identification Number of the
control subject (object)
_______________________________________________________________
Location address
№ | List of requirements | Compliance with requirements | Non-compliance with requirements |
1. | Compliance with all production processes of medicines and medical devices (GMP) | ||
2. | Availability of state registration in the Republic of Kazakhstan of medicinal substances used in production, with the exception of those produced under Good Manufacturing Practice conditions | ||
3. | Availability of forwarding documents for medicines and medical productsв | ||
4. | Carrying out activities for the production of medicines or wholesale distribution of medicines by suppliers of substances or intermediate products | ||
5. | Compliance of substances, excipients, consumables and packaging materials with the registration dossier | ||
6. | Incoming control of raw materials (substances, auxiliary materials), materials, semi-finished products, components; intermediate control during the production process, control of finished pharmaceutical products | ||
7. | Availability of a quality assurance system, documentation and control of its efficacy in production | ||
8. | Ensuring registration of all technological and auxiliary operations during the production of a separate series of medicines and medical devices | ||
9. | Compliance with the requirements for maintaining documentation of all production processes and materials used in production, its storage order | ||
10. | Compliance with stability testing, shelf-life establishment, and revalidation of medications. | ||
11. | Ensuring that the number of samples is sufficient for testing when necessary (arbitration tests) | ||
12. | Availability of markings indicating the status of manufactured products, initial products, packaging materials | ||
13. | Quality control of materials, intermediate products, finished products. | ||
14. | Maintaining of database of side effects of medicines and medical devices | ||
15. | Availability of a health specialist certificate for each pharmacy worker | ||
16. | Availability of a state license for pharmaceutical activities and of attachments for subtypes of activity or notification of the commencement of activity. Compliance with the types and subtypes of activities declared upon receipt of the state license and attachment to it | ||
17. | Ensuring storage and transportation in accordance with the conditions established by the manufacturer in the regulatory and technical document on monitoring the quality and safety of medicines, in the instructions for medical use for medicines and medical devices, operational documents (for the medical device), indicated in the labeling of their packages | ||
18. | Ensuring safety, storage conditions and handling of various groups of medicines and medical devices by complying with the requirements for design, arrangement, composition, size of the areas, equipment of premises (areas) for storage of medicines and medical devices and their operation, ensuring the safety | ||
19. | Observance of storing medicines and medical devices separate from other products to avoid any impact on them, protection from negative impact of light, temperature, moisture and other external factors | ||
20. | Keeping records of the expiry dates of medicines and medical devices on paper or electronic media | ||
21. | Storage of medicines and medical devices in designated and clearly marked storage areas | ||
22. | Provision of storage premises, including a refrigerating room (chamber) with appropriate equipment for control of temperature, air humidity (thermometers, hygrometers, other types of devices) and their location on the internal walls of the premises away from heating devices based on the results of testing of temperature fluctuation zones for cold and warm seasons | ||
23. | Observance of separation during storage of all medicines and medical devices depending on the pharmacological group, administration method, aggregate state, physicochemical properties, exposure to various environmental factors | ||
24. | Availability of isolated storage space for pending, expired, returned, withdrawn, presumably counterfeit, recalled and rejected medicinal products | ||
25. | Provision of weather protection in the receiving and discharge areas. Availability of equipment in receiving and discharge areas (ventilation/air conditioning system, hygrometer, thermometer), container cleaning equipment. Availability of an equipped area for inspection of received products | ||
26. | Separation of acceptance, quarantine, defective, discharge and storage areas. Availability of a room in which medicines are stored in quarantine, clearly marked and with limited access | ||
27. | Availability of common non-combustible buildings with insulation by non-combustible walls from neighboring premises that meet fire safety requirements in the absence of separate storage facilities for flammable substances, provision of premises with supply and exhaust ventilation | ||
28. | Storage of flammable medicines separately from other medicines: provision of fireproof and stable racks and pallets, storage of flammable and combustible liquids in built-in fireproof cabinets with doors at least 0.7 meters wide and 1.2 meters high | ||
29. | Storage of flammable liquids isolated in separate rooms in glass or metal containers from other groups | ||
30. |
Compliance with the storage of flammable and combustible liquid medicines that should not be stored: | ||
31. | Compliance with isolated storage of calcium hypochloride, taking into account its properties | ||
32. | Compliance with the storage of flammable liquids with constant monitoring of the condition of containers, their tightness and serviceability | ||
33. | Implementation of measures in the storage of explosive medicines against their contamination by dust | ||
34. | Compliance with separate storage of explosive and flammable medicines containing acids and alkalis | ||
35. | Ensuring protection of cylinders with oxygen and flammable gases from heat sources, contact with oil and other greasy substances, and their storage in isolated rooms or under sheds | ||
36. | Observance of conditions of storing dressings in a dry ventilated area in cabinets, drawers, on racks, pallets, trays, in conditions ensuring cleanliness | ||
37. | Compliance with the conditions of storing medical instruments, devices, appliances, equipment in dry heated rooms at room temperature, with relative humidity not exceeding 65 percent | ||
38. | Compliance with the requirements for interior finishing of premises (areas) for storing medicines and ensuring cleanliness of storage premises and equipment | ||
39. | Providing protection against the entry of insects, rodents or other animals, and presence of preventive pest control program | ||
40. |
Separation of rest rooms, dressing rooms, showers and toilets for employees from storage rooms (areas). Food, beverages, tobacco products, as well as medicines for personal use shall not be stored in storage rooms (areas). | ||
41. |
Provision of the necessary equipment and inventory in drug storage areas: | ||
42. | Availability of a document on calibration (verification) of equipment used for control and monitoring of storage conditions | ||
43. | Availability of a developed and approved emergency plan in case of malfunction of the refrigeration room (chamber), refrigeration equipment or power outage, emergency situations | ||
44. | Availability of developed and approved instructions for cleaning and disinfection of equipment. The used equipment shall be in good condition and kept in proper cleanliness | ||
45. | Availability of a person responsible for ensuring the safety of the quality of medicines and medical devices at the facilities storing medicines and medical devices. | ||
46. | Availability of a commission for the destruction of medicines and medical devices unsuitable for sale and medical use. | ||
47. | Availability of acts on the destruction of medicines and medical devices unsuitable for sale and medical use. | ||
48. |
Availability of secondary package labeling including the following information: | ||
49. |
Availability of primary packaging labeling indicating the following information: | ||
50. | Organization of work to monitor adverse reactions and (or) lack of efficacy of medicines and medical devices, appointment of responsible persons for monitoring side effects of medicines and medical devices | ||
51. | Provision by the responsible person to the authorized organization of information about side effects and (or) lack of efficacy of medicines and medical devices. Transmission of message cards through the portal of an authorized organization online containing a mandatory minimum amount of information | ||
52. | Compliance with the deadlines for submitting a completed report card about adverse reactions (actions) and (or) efficacy to the authorized organization in cases of detection | ||
53. | Absence of facts of procurement, production, storage, advertising, use, provision and sale of medicines and medical devices that have not passed state registration in the Republic of Kazakhstan | ||
54. | Absence of facts of production, importation, storage, use and sale of counterfeit medicines and medical devices | ||
55. | Absence of facts of sale of medicines and medical devices, the quality of which is not confirmed by the conclusion on safety and quality | ||
56. | Absence of facts of storage, use and sale of expired medicines and medical devices | ||
57. | Compliance of the medicinal product with the requirements of the regulatory document on quality and safety control of the medicinal product and medical device (based on the results of safety and quality assessment of samples withdrawn as doubtful) | ||
58. |
Compliance with the requirements for storage, accounting, destruction of medicines containing narcotic drugs, psychotropic substances and precursors (including substances): | ||
59. | Availability of a list of persons who have conclusions from psychiatrists and narcologists about the absence of drug addiction, substance abuse, chronic alcoholism, as well as about suitability for carrying out activities related to narcotic drugs, psychotropic substances and their precursors and the conclusion of the internal affairs bodies on conducting the relevant check | ||
60. | Storage rooms, safes and cabinets shall be kept closed. After the end of the working day, they shall be sealed and (or) stamped. Keys, seal and (or) sealer shall be kept with the responsible person | ||
61. | Availability of a first aid kit | ||
62. | Availability of a signboard indicating the name of the pharmaceutical activity subject, its organizational and legal form and operation mode in the state and Russian languages | ||
63. | Availability of information on telephone numbers and addresses of territorial subdivisions of the state body in the sphere of circulation of medicines and medical devices in a place convenient for the population’s viewing | ||
64. | Ensuring traceability of medicinal products labeled with identification means by providing by participants of circulation of medicinal products and entities in the sphere of circulation of medicinal products and medical devices of information on launch into circulation, on sale and (or) transfer, as well as on withdrawal of labeled medicinal products from circulation on the territory of the Republic of Kazakhstan | ||
65. |
Compliance with the rules of advertising medicinal products and medical devices: | ||
66. |
Non-admission of advertising of medicines and medical devices: | ||
67. | Compliance with manufacturer's price limits | ||
68. | Availability of a certificate of compliance with the requirements of the Good Manufacturing Practice (GMP) Standard |
Designated person (s)
__________________________________________________________________________
position, signature
__________________________________________________________________________
surname, name, patronymic (if any)
The head of the control subject
__________________________________________________________________________
position, signature
__________________________________________________________________________
surname, name, patronymic (if any).
| Appendix 19 to the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated November 15, 2018 № ҚР ДСМ-32 and the Minister of National Economy of the Republic of Kazakhstan dated November 15, 2018 №70 |
Checklist in the field of circulation of medicines and medical devices regarding subjects (objects)
of pharmaceutical activity, engaged in manufacturing of medicines and medical devices
Footnote. Appendix 19 as amended by the joint order of the Acting Minister of Healthcare of the Republic of Kazakhstan dated 24.05.2023 №87 and the Minister of National Economy of the Republic of Kazakhstan dated 24.05.2023 № 77 (effective ten calendar days after the date of its first official publication).
State body that appointed inspection/preventive control with a visit to the
control subject (object) _______________________________________________________
__________________________________________________________________________
Act on appointing inspection / preventive control with a visit to control subject (object) _____
__________________________________________________________________________
№, date
Name of the control subject (object)
__________________________________________________________________________
(Individual Identification Number), Business Identification Number of the
control subject (object)
_______________________________________________________________
Location address
Designated person (s)
__________________________________________________________________________
position, signature
__________________________________________________________________________
surname, name, patronymic (if any)
The head of the control subject
__________________________________________________________________________
position, signature
__________________________________________________________________________
surname, name, patronymic (if any).
| Annex 2 to the joint order of the Minister of Health of the Republic of Kazakhstan dated November 15, 2018 № KR DSM -32 and Minister of national economy of the Republic of Kazakhstan dated November 15, 2018 № 70 |
The Checklist
Footnote. Appendix 2 - as amended by the joint order of the Acting Minister of Health of the Republic of Kazakhstan dated 31.03.2025 № 27 and Deputy Prime Minister - Minister of National Economy of the Republic of Kazakhstan dated 07.04.2025 № 16 (effective ten calendar days after the date of its first official publication).
in the field of provision of medical services (aid)
___________________________________________________________________
in accordance with article 138
___________________________________________________________________
The Entrepreneurial Code of the Republic of Kazakhstan in relation to entities (objects) providing stationary, inpatient replacement care name of a homogeneous group of entities (objects) of control
___________________________________________________________________
The state body that appointed the inspection/preventive control with a visit to the entity (object) of control
___________________________________________________________________
___________________________________________________________________
An act on the appointment of an inspection/preventive control with a visit to the entity (object) of control __________________________________________
____________________________________________________________ №, date
Name of the entity (object) of control _____________________________
___________________________________________________________________
(Individual identification number), business identification number of the entity (object) of control ____________________________________
___________________________________________________________________
Location address _____________________________________________
___________________________________________________________________
№ | List of requirements | Meet the requirements | Do not meet the requirements |
1 | 2 | 3 | 4 |
1 | Availability of documentation confirming the provision of medical care included in the guaranteed amount of free medical care and (or) the system of compulsory social health insurance on a free basis | ||
2 | Availability of a signed contract of co-insurance of professional liability of medical workers | ||
3 | Availability of a conclusion on the compliance of the healthcare entity with the provision of high-tech medical care | ||
4 | Availability of written voluntary consent of the patient or his legal representative for invasive interventions and for carrying out medical and diagnostic measures | ||
5 | The presence of an entry in the medical documentation ("Emergency medical team call card" form № 085/y, "Journal of admission and refusals to hospitalization", "Inpatient medical card" form №001/y) confirming the arrival of the ambulance station team in the department of primary health care or in the hospital admission department, not exceeding 10 minutes (the time for the transfer of the patient to the doctor of the emergency department) from the moment of its arrival to the hospital, except in cases of emergency medical care | ||
6 |
Availability of an entry in the medical documentation confirming the patient's admission to the hospital's emergency department, with an initial assessment and medical triage (hereinafter referred to as medical triage) in a certain group, based on the patient's condition, his possible deterioration and the priority of emergency medical care. | ||
7 | Availability of medical documentation (form № 001/u "Inpatient medical record") confirming the hospitalization of a serious patient in need of constant monitoring of vital functions for medical reasons, by decision of the council and notification of the heads of healthcare organizations, followed by transfer to another medical organization according to the disease profile for further examination and treatment after stabilization of the condition | ||
8 | Availability of medical documentation confirming the medical report of the doctor of the admission department with a written justification for refusal in the absence of indications for hospitalization to a healthcare organization ("Journal of admission and refusals to hospitalization" from medical information systems (hereinafter referred to as MIS), certificate in the form № 027/u (refusals to hospitalization)). The nurse of the admission department sends a report to the PHC organization at the patient's place of attachment | ||
9 |
Availability of records in medical documentation ("Journal of patient admission and refusals to hospitalization" from the MIS, coupons for planned hospitalization, "Inpatient medical record" (form № 001/u) on indications for hospitalization: | ||
10 | Availability of an entry in the medical documentation (form № 001/u "Inpatient medical record") confirming the examination of serious patients by the head of the department on the day of hospitalization, and subsequently - daily. Patients in moderate condition are examined at least once a week. The results of the patient's examination are recorded in the medical record with recommendations on further patient treatment tactics, with mandatory identification of the medical specialist making the entries. | ||
11 | Availability of an established clinical diagnosis in conjunction with the head of the department no later than three calendar days from the date of the patient's admission to the healthcare organization in the form № 001/u "Inpatient medical record" | ||
12 | Availability of an entry in the medical documentation (form №001/u "Inpatient medical record") confirming the daily examination of patients by the attending physician in the hospital except weekends and holidays. During the examination and appointment of additional diagnostic and therapeutic manipulations by the doctor on duty, appropriate entries are made in the medical record. If the patient's condition worsens, the doctor on duty notifies the head of the department and (or) the attending physician, coordinates changes to the diagnosis and treatment process, and makes an entry in the medical record (paper and (or) electronic version). An entry is made in the electronic version of the medical record no later than one day after the patient's condition changes. In case of emergencies, the frequency of entries depends on the dynamics of the severity of the condition. The hospital doctor's records reflect specific changes in the patient's condition and the need for correction of prescriptions, justification for the prescribed examination and treatment, assessment and interpretation of the results obtained and the effectiveness of the treatment. Frequency of examination in case of emergency conditions at least every 3 hours, indicating the time of emergency care by hours and minutes | ||
13 |
Availability of supporting medical documentation on compliance with the requirements for planned hospitalization: | ||
14 | Availability of an entry in the medical documentation on consultations or consultation in case of difficulty in identifying the diagnosis, ineffectiveness of the treatment, as well as other indications | ||
15 |
Availability of an entry in the medical documentation on compliance with the criteria at discharge, in particular: | ||
16 | Availability of an entry in the medical documentation on the issuance of a discharge epicrisis to the patient upon discharge, indicating the full clinical diagnosis, the amount of diagnostic studies performed, therapeutic measures, and recommendations for further follow-up and treatment. Discharge data is entered into information systems day by day, indicating the actual time of discharge. | ||
17 | Availability of an informed written consent of the patient for transfusion of blood and its components | ||
18 | Availability of an entry in the medical documentation (form № 001/u "Inpatient medical record") confirming the examination of the recipient before transfusion for markers of hemotransmissive infections (HIV, hepatitis B and C), as well as recommendations in the discharge epicrisis on the need for repeated examination for HIV and hepatitis B and C in the PHC organization at the place of attachment after 1, 3, 6 months | ||
19 | Availability of a contract in a medical organization for the purchase and delivery of blood and its components | ||
20 | Availability of documentation (an internal document approved by the first supervisor) confirming the distribution of functions of employees involved in each stage of blood transfusion and its components | ||
21 | Availability of an entry in the medical documentation (the result of a group study using the ABO system and Rhesus affiliation, screening of irregular antierythrocyte antibodies in the form 098/u or an entry in electronic form 001/u "Hospital patient's medical record") confirming the immunohematological examination of recipients to ensure the safety of transfusion therapy | ||
22 | Availability of an entry in the medical documentation confirming the establishment of indications for the appointment of blood and its components based on clinical manifestations of deficiency or dysfunction of cellular or other blood components, confirmed by laboratory data ("Pretransfusion epicrisis" addendum 6 to the inpatient patient's medical record form 001/u) | ||
23 | Availability of documentation (an internal document approved by the first supervisor) confirming the continuous training of personnel involved in transfusion therapy and the admission of medical personnel and mid-level medical personnel to perform transfusion care | ||
24 | Availability of medical documentation confirming the transfer of reports from the hospital to the PHC about the patients who underwent hemotransfusion | ||
25 | Availability of medical documentation ("Diary" insert sheet 2 to the medical record of inpatient patient form 001/u) confirming the control of the effectiveness of blood transfusion and its components | ||
26 | Maintaining forms of accounting documentation in the field of healthcare (form № 003/u "Form of accounting for the movement of blood, its components and diagnostic standards" on electronic and (or) paper media; Insert sheet 6 to the inpatient patient's medical record form 001/u "Pretransfusion epicrisis", "Protocol of transfusion of components", "Transfusion sheet", Form № 006/u "Registration form for blood transfusion, its components, preparations", Form № 007/u "Registration form for blood recipients and its components") on electronic and (or) paper media | ||
27 |
Availability of supporting medical documentation on indications for admission to a day hospital at outpatient health organizations and to a hospital at home: | ||
28 |
Availability of supporting medical documentation on the examination of persons for clinical indications for HIV infection in the detection of the following diseases, syndromes and symptoms: 1) enlargement of two or more lymph nodes lasting more than 1 month, persistent, generalized lymphadenopathy; | ||
29 | Availability of a contract for the provision of paid medical services in healthcare organizations. Availability of documents confirming the fact of co-payment | ||
30 |
Availability of an entry in the medical documentation confirming compliance with the requirements for the examination of temporary disability, the issuance of a sheet and a certificate of temporary disability (form № 001/u "Medical record of an inpatient patient", form 052/u "Medical record of an outpatient patient", extracts of sheets on temporary disability of patients, form № 025/u "Journal to record the conclusions of the medical advisory commission", form № 029/u "Book of registration of temporary disability sheets", form № 037/u "Certificate №__________ about the temporary disability of a student, student of college, vocational school, illness, quarantine and other reasons for the absence of a child attending school, preschool organization (please underline)", form № 038/u "Certificate № ______ of temporary disability" and others): | ||
31 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical certificates) on the conduct of a clinical audit by the Patient Support Service and internal expertise and its assessment according to the following criteria: | ||
32 |
Availability of documentation confirming compliance with the actions during the autopsy: | ||
33 | Availability of a written statement from the spouse, close relatives or legal representatives of the deceased, or a written statement of the will given by the person during his lifetime to release the corpse without conducting a pathoanatomic autopsy, in the absence of suspicion of violent death. | ||
34 | Availability of an entry in the medical documentation followed by the collection of biological materials to determine the content of a psychoactive substance, with the results recorded in a medical record if signs of substance use are detected while seeking medical help from a healthcare organization without issuing a medical examination to establish the fact of substance use and intoxication. | ||
35 | Availability of supporting medical documentation on the implementation of therapeutic and diagnostic measures, drug provision, organization of therapeutic nutrition and appropriate patient care from the moment of admission to the healthcare organization ("Inpatient medical record" form № 001/u) | ||
36 | Availability of an entry in the medical documentation confirming the use of consulting opportunities with relevant republican organizations through the telemedicine network in case of difficulty in verifying the child's diagnosis and determining treatment tactics. If necessary, the patient is transferred to specialized republican organizations. | ||
37 | Availability of an entry in the medical documentation confirming the provision of supportive care (support for adequate feeding, maintaining water balance, pain control, fever management, oxygen therapy) | ||
38 | Availability of an entry in the medical documentation confirming the daily examination of the patient by a doctor, an examination by the head of department (upon admission on the first day, repeatedly at least once a week) | ||
39 |
Availability of an entry in the medical documentation confirming compliance with the requirements of providing anesthesiological and intensive care: | ||
40 | Availability of supporting medical documentation on medical rehabilitation for the underlying disease (form № 001/u "Inpatient medical record", form № 047/u "Rehabilitation medical record"). The appointment of the first stage of rehabilitation after consultation with a rehabilitologist to prevent complications and accelerate functional recovery as part of the treatment of the underlying disease according to clinical protocols. The duration of the course of medical rehabilitation, the list and the scope of services are determined based on the opinion of a rehabilitologist or a multidisciplinary group (hereinafter referred to as MDG), taking into account the basic treatment of the underlying disease with the registration of the medical part of the individual rehabilitation program of the patient. | ||
41 | Availability of an entry in the medical documentation confirming the examination by the head of the department upon admission of neurosurgical patients and subsequently, if necessary, for the disease ("Inpatient medical record" form № 001/u) | ||
42 |
Availability of an entry in the medical documentation confirming compliance with the requirements of providing ophthalmological care in an inpatient condition: | ||
43 |
Availability of an entry in the medical documentation confirming compliance with the requirements of the organization of medical care for acute cerebral circulatory disorders (hereinafter referred to as ACCD) at the inpatient level in stroke centers (SC): | ||
44 |
Availability of an inpatient's medical record approved in form № 001/u "Inpatient's medical record", which is the main medical document of a medical organization, which is filled out for each patient admitted to the hospital. |
Official (s) _________________________________ ___________
position signature
____________________________________________________________________
last name, first name, patronymic (if any)
Head of the entity of control ____________________________ ___________
position signature
____________________________________________________________________
last name, first name, patronymic (if any)
The Checklist
Footnote. Appendix 3 - as amended by the joint order of the Acting Minister of Health of the Republic of Kazakhstan dated 31.03.2025 № 27 and Deputy Prime Minister - Minister of National Economy of the Republic of Kazakhstan dated 07.04.2025 № 16 (effective ten calendar days after the date of its first official publication).
in the field of provision of medical services (aid)
________________________________________________________________________
in accordance with article 138
________________________________________________________________________
of the Entrepreneurial Code of the Republic of Kazakhstan in relation to _ entities (objects), providing outpatient clinic assistance (primary health care and consultative diagnostic assistance) ________________________________________________________________
name of the homogeneous group of entities (objects) of control
________________________________________________________________________
The state body that appointed the inspection/preventive control with a visit to the entity (object) of control ___________________________________
________________________________________________________________________
An act on the appointment of an inspection/preventive control with a visit to the entity (object) of control ________________________________________________________
_________________________________________________________________ №, date
Name of the entity (object) of control __________________________________
________________________________________________________________________
(Individual identification number), business identification number of the entity (object) of control _______________________________________________
________________________________________________________________________
Location address __________________________________________________
________________________________________________________________________
№ | The list of requirements | Meet the requirements | Do not meet the requirements |
1 | 2 | 3 | 4 |
1 | Availability of documentation confirming the provision of medical care included in the guaranteed amount of free medical care and (or) the system of compulsory social health insurance on a free basis | ||
2 | Availability of a signed contract of co-insurance of professional liability of medical workers | ||
3 | Availability of written voluntary consent of the patient or his legal representative for invasive interventions and for carrying out medical and diagnostic measures | ||
4 | Availability of an outpatient's medical record on compliance of the performed therapeutic and diagnostic measures with the recommendations of clinical protocols | ||
5 |
Availability of documentation confirming compliance with the requirements for the organization and conduct of the Medical Advisory Commission (MAC): | ||
6 |
Availability of supporting documentation on compliance with the requirements of PHC organizations during preventive medical examinations of target populations: | ||
7 |
Availability of supporting documentation on the compliance with the levels of medical rehabilitation for patients: | ||
8 |
Availability of documentation confirming the compliance of TB care at the outpatient level with the following requirements: | ||
9 77 |
Availability of an entry in the medical documentation confirming compliance with the requirements for providing oncological care in the form of outpatient care: | ||
10 | Availability of mandatory confidential medical examination for HIV infection in persons for clinical and epidemiological indications, including sexual partners of pregnant women, persons who applied voluntarily and anonymously | ||
11 |
Availability of supporting medical documentation on compliance of an obstetrician-gynecologist with the requirements of the measures during a woman's initial treatment for pregnancy and, if desired, to preserve it: | ||
12 |
Availability of an entry in the medical documentation confirming compliance of an obstetrician-gynecologist with the requirements for the provision and organization of obstetric and gynecological care for women during pregnancy and after childbirth, the provision of family planning and reproductive health services, as well as the prevention, diagnosis and treatment of gynecological diseases of the reproductive system: | ||
13 | Availability of results and additional data from subsequent examinations and research in form № 077/u "Individual record of pregnant woman and women in labor № ___" and in form № 048/u "Individual card of pregnant woman and women in labor №___" at each visit of the pregnant woman to the obstetrician-gynecologist | ||
14 | Availability of an entry in the medical documentation confirming the conduct of home care by a midwife or a nurse for pregnant women who did not show up for an appointment within 3 days after the scheduled date | ||
15 | The presence in the medical documentation of the conclusion of the MAC on the possible pregnancy in women with contraindications to pregnancy due to extragenital pathology | ||
16 | Availability of a contract for the provision of paid medical services in healthcare organizations. Availability of documents confirming the fact of co-payment | ||
17 |
Availability of documentation confirming the compliance of the average medical professional of the medical center of the educational organization with the requirements: | ||
18 |
Availability of medical documentation confirming compliance with the requirements during the examination of temporary disability, issuance of a sheet and a certificate of temporary disability (form №001/u "Inpatient medical record", form 052/u "Outpatient medical record ", extracts of sheets on temporary disability of patients, form № 025/u "Journal for recording conclusions of the medical advisory commission", form № 029/u "Book of registration of temporary disability sheets", form № 037/u "Certificate № ____ on temporary disability of a student of college, vocational school, on illness, quarantine and other reasons for the absence of a child attending school, a preschool organization (underline)", form № 038/u "Certificate № ____ on temporary disability" and others): | ||
19 |
Availability of an entry in the medical documentation confirming compliance with the requirements for issuing a sheet and a certificate of temporary disability for pregnancy and childbirth: | ||
20 |
Availability of supporting documentation (internal orders, regulations, protocols, questionnaires, analytical certificates) on the conduct of a clinical audit by the patient support service and internal expertise and its assessment according to the criteria: | ||
21 |
Availability of an entry in the medical documentation confirming compliance with the requirements for providing surgical (abdominal, thoracic, coloproctological) care to patients at the outpatient level. | ||
22 | Availability of an entry in the medical documentation confirming compliance with the requirements of PHC organizations for the dynamic monitoring of persons with chronic diseases, compliance with the frequency and timing of follow-up, the mandatory minimum and multiplicity of diagnostic tests | ||
23 | Availability of an entry in the medical documentation confirming compliance with the requirements for active home visits by PHC staff | ||
24 |
Availability of an entry in the medical documentation confirming compliance with the requirements for the provision of pediatric care: | ||
25 |
Availability of an entry in the medical documentation confirming compliance with the requirements for providing traumatological and orthopedic care at the outpatient level: | ||
26 |
Availability of an entry in the medical documentation confirming compliance with the requirements of neurological care at the outpatient level: | ||
27 |
Availability of an entry in the medical documentation confirming compliance with the requirements of nephrological care: | ||
28 |
Availability of an entry in medical documentation confirming compliance with the requirements of providing neurosurgical care on an outpatient basis: | ||
29 | Reasoned execution of the MSE expert opinion notification, form № 031/u (availability of data for a comprehensive assessment of the body's condition and the degree of "disability”) | ||
30 |
Availability of an entry in the medical documentation confirming the observance of patronage: 1) children under 5 years of age, including newborns; | ||
31 |
Availability of an entry in the medical documentation confirming the observance of an active visit to the patient at home by a PHC specialist at: | ||
32 | Availability of an entry in the medical documentation confirming compliance with the indications for home call services | ||
33 | Availability of an entry in the medical documentation confirming the provision of preventive medical examinations of target groups and early detection of behavioral risk factors | ||
34 | Availability of an entry in the medical documentation confirming the provision of medical rehabilitation, palliative care and nursing services | ||
35 |
Availability of an entry in the medical documentation confirming the provision of specialized medical care in outpatient settings for diseases requiring special methods of diagnosis, treatment, and medical rehabilitation: | ||
36 | Availability of an entry in the medical documentation confirming the provision of PHC services covering prevention, diagnosis and treatment to all patients, regardless of their location | ||
37 | Availability of an entry in the medical documentation confirming the provision of pre-medical care by secondary medical workers for diseases or in cases that do not require the participation of a doctor according to the list of medical services provided by PHC medical workers | ||
38 | Availability of an entry in the medical documentation confirming the provision of qualified medical care according to the list of medical services provided by PHC doctors | ||
39 | Availability of an entry in the medical documentation confirming the provision of an emergency medical team call and the referral of the patient in an emergency form to a 24-hour hospital according to the profile when contacting the PHC organization for an emergency condition | ||
40 |
Availability of medical documentation confirming compliance with the provision of specialized medical care in outpatient settings within the guaranteed volume of free medical care and (or) in the compulsory social health insurance system without referral of specialists at the primary and secondary levels of medical care: | ||
41 | Availability of documentation confirming the organization and implementation of a set of measures for the prevention and active early detection of precancerous and oncological diseases, patients with mental and behavioral disorders |
Official (s) _______________________________ ____________
position signature
___________________________________________________________________
last name, first name, patronymic (if any)
The head of the entity of control __________________________ ____________
position signature
___________________________________________________________________
last name, first name, patronymic (if any)
| Annex 4 to the joint order of the Minister of healthcare of the Republic of Kazakhstan dated November 15, 2018 № KR DSM-32 and Minister of national economy of the Republic of Kazakhstan dated November 15, 2018 № 70 |
The Checklist
Footnote. Appendix 4 - as amended by the joint order of the Acting Minister of Health of the Republic of Kazakhstan dated 31.03.2025 № 27 and Deputy Prime Minister - Minister of National Economy of the Republic of Kazakhstan dated 07.04.2025 № 16 (effective ten calendar days after the date of its first official publication).
in the field of medical services (aid)
_______________________________________________________________________
in accordance with article 138
______________________________________________________________________
of the Entrepreneurial Code of the Republic of Kazakhstan
in relation to entity (objects) of maternity care and (or) inpatient
organizations that include maternity and neonatal pathology departments,
the name of a homogeneous group of entities (objects) of control
______________________________________________________________________
The state body that appointed
the inspection/preventive control with a visit to the entity (object) of control
__________________________________
_______________________________________________________________________
An act on the appointment of an inspection/preventive control
with a visit to the entity (object) of control
______________________________________________________
_______________________________________________________________ №, date
Name of the entity (object) of control _________________________________
_______________________________________________________________________
(Individual identification number), business identification number
of the entity (object) of control ______________________________________________
______________________________________________________________________
Location address _________________________________________________
_____________________________________________________________________
№ | List of requirements | Meet the requirements | Do not meet the requirements |
1 | 2 | 3 | 4 |
1. | Availability of a conclusion on the compliance of a healthcare entity with the provision of high–tech medical care when organizing the provision of high-tech services, including in vitro fertilization (hereinafter referred to as IVF) | ||
2. | Availability of documentation confirming the provision of medical care included in the guaranteed amount of free medical care and (or) the system of compulsory social health insurance on a free basis | ||
3. | Availability of a signed contract of co-insurance of professional liability of medical workers | ||
4. | Availability of written voluntary consent of the patient or his legal representative for invasive interventions and for carrying out medical and diagnostic measures | ||
5. | Availability of medical documentation ("Emergency medical team call record" form № 085/u, "Journal of admission and refusal for hospitalization", "Inpatient medical record" form №001/u) confirming the stay of the ambulance station team at the emergency medical services department at the PHC organization or at the hospital admission department, not exceeding 10 minutes (time for transfer of the patient to the doctor of the emergency department) from the moment of its arrival at the hospital, except in cases of emergency medical care | ||
6. |
Availability of an entry in the medical documentation confirming the patient's admission to the hospital's emergency department, with an initial assessment and medical triage (hereinafter referred to as medical triage) in a certain group, based on the patient's condition, its possible deterioration and the priority of emergency medical care. Medical triage is carried out continuously and in succession. Upon completion of the assessment, the patient is marked with the color of one of the sorting categories, in the form of a special color tag or a colored ribbon. According to medical triage, there are 3 groups of patients: | ||
7. | Availability of a medical certificate issued by the doctor of the admission department with a written justification for the refusal in the absence of indications for hospitalization in a healthcare organization. The presence of an asset sent by the nurse of the admission department to the PHC organization at the patient's place of attachment | ||
8. |
Availability of an entry in the medical documentation confirming the indications for hospitalization: | ||
9. | Availability of an entry in the medical documentation confirming the examination of serious patients by the head of the department on the day of hospitalization, and subsequently on a daily basis. Patients in moderate condition are examined at least once a week. The presence of the results of the patient's examination recorded in the medical record indicating recommendations for further patient treatment tactics with mandatory identification of the medical professional making the entries | ||
10. | Availability of an entry in the medical documentation confirming the daily examination by the attending physician of patients in the hospital, except weekends and holidays. The presence of relevant entries in the medical record during the examination and appointment of additional diagnostic and therapeutic manipulations by the doctor on duty | ||
11. | Availability of a justification in the medical record for a dynamic assessment of the patient's condition according to clinical diagnostic and treatment protocols when additional and repeated studies conducted before hospitalization in a PHC or other healthcare organization are identified for medical reasons. | ||
12. |
Availability of medical documentation confirming compliance with the requirements for issuing a sheet and a certificate of temporary disability for pregnancy and childbirth: | ||
13. |
Availability of an entry in the medical documentation confirming compliance with the requirements for the examination of temporary disability, the issuance of a sheet and a certificate of temporary disability (form №001/u "Medical record of an inpatient patient", form 052/u "Medical record of an outpatient patient", extracts of sheets on temporary disability of patients, form № 025/u "Journal to record the conclusions of the medical advisory commission", form № 029/u "Book of registration of sheets on temporary disability", form № 037/u "Certificate № ___ on temporary disability of the student, student of college, vocational school, on illness, quarantine and other reasons for the absence of a child attending school, preschool organization (please underline)", form № 038/u "Certificate № ______ of temporary disability" and others): | ||
14. | Availability of informed written consent of the patient for transfusion of blood and its components | ||
15. | Availability of an entry in the medical documentation (form № 001/u "Inpatient medical record") confirming the examination of the recipient before transfusion for markers of hemotransmissive infections (HIV, hepatitis B and C), as well as recommendations in the discharge epicrisis on the need for repeated examination for HIV and hepatitis B and C in the PHC organization at the place of attachment after 1, 3, 6 months | ||
16. | Availability in a medical organization of a contract for the purchase and delivery of blood and its components | ||
17. | Availability of documentation (an internal document approved by the first supervisor) confirming the distribution of functions of employees involved in each stage of blood transfusion and its components | ||
18. | Availability of an entry in the medical documentation (the result of a group study using the ABO system and Rhesus affiliation, screening of irregular antierythrocyte antibodies in form 098/u or an entry in electronic form 001/u "Hospital patient's medical record") confirming the immunohematological examination of recipients to ensure the safety of transfusion therapy | ||
19. | Availability of an entry in the medical documentation confirming the establishment of indications for the appointment of blood and its components based on clinical manifestations of deficiency or dysfunction of cellular or other blood components, confirmed by laboratory data ("Pretransfusion epicrisis" addendum 6 to the inpatient patient's medical record form 001/u) | ||
20. | Availability of documentation (an internal document approved by the first supervisor) confirming continuous training of personnel involved in transfusion therapy and admission to transfusion care for medical personnel and mid-level medical personnel | ||
21. | Availability of medical documentation confirming the transfer of assets from the hospital to PHC for patients who underwent hemotransfusion | ||
22. | Availability of medical documentation ("Diary" insert sheet 2 to the medical record of inpatient patient f 001/u) confirming the control of the effectiveness of blood transfusion and its components | ||
23. | Maintaining forms of accounting documentation in the field of healthcare (form № 003/u "Form of accounting for the movement of blood, its components and diagnostic standards" on electronic and (or) paper media; Insert sheet 6 to the inpatient patient's medical record form 001/u "Pretransfusion epicrisis", "Protocol of transfusion of components", "Transfusion sheet", Form № 006/u "Registration form for blood transfusion, its components, preparations", Form № 007/u "Registration form for blood recipients and its components") on electronic and (or) paper media | ||
24. |
Availability of medical documentation confirming compliance with the actions during the autopsy: | ||
25. |
Availability of medical documentation confirming compliance with the following requirements for the organization of obstetric and gynecological care at the outpatient level: | ||
26. | Availability of a written consent of both spouses for the use of germ cells and tissues of reproductive organs by a married recipient | ||
27. | Availability of documentation confirming the birth of 10 (ten) children from one donor, which is the basis for the termination of the use of this donor for recipients | ||
28. |
Availability of documentation confirming the donation of germ cells and tissues of reproductive organs from a donor, subject to the following conditions: | ||
29. | Availability of written informed consent of the donor for the induction of superovulation or in a natural cycle in compliance with the requirements for donors of germ cells, tissues of reproductive organs with the passage by an oocyte donor of medical and genetic examination | ||
30. |
Availability of medical documentation confirming IVF according to indications using donor oocytes: | ||
31. | Availability of medical documentation confirming that an obstetrician-gynecologist (reproductologist) works with donors, a medical examination of the donor before each procedure for collecting donor material, and monitoring the timeliness and results of laboratory tests in accordance with the examination schedule | ||
32. |
Availability of medical documentation confirming the performance of oocyte donation according to the following algorithm: | ||
33. |
Availability of an entry in the medical documentation confirming compliance with the requirements for refusal of IVF using donor oocytes with contraindications: | ||
34. |
Availability of an entry in the medical documentation confirming the use of donor sperm during assisted reproductive methods and technologies (hereinafter referred to as ART). Sexual abstinence for 3-5 days is required before sperm donation. Sperm is obtained through masturbation. The ejaculate is collected in a special sterile, pre-labeled container. This procedure is carried out in a special room with a separate entrance, an appropriate interior, and a sanitary unit with a washbasin. | ||
35. |
Availability of medical documentation confirming IVF using donor sperm according to the indications: | ||
36. | Availability of an individual donor record filled out and coded by the doctor (the coding scheme is free, the donor's application and his individual record are stored in a safe as documents for official use) | ||
37. |
Availability of an entry in the medical documentation confirming the work with donors by a uroandrologist and an embryologist. The doctor organizes medical examinations of the donor, monitors the timeliness and results of laboratory tests in accordance with the examination schedule. | ||
38. |
Availability of documentation confirming compliance with the requirements that embryo donors are IVF patients who have the unused cryopreserved embryos in the bank. By free decision and written informed consent of the patients, these embryos are disposed of or donated to a medical organization. The embryos transferred to a medical organization are used for gratuitous donation to an infertile married couple, to unmarried women (recipients). | ||
39. | Availability of an entry in the medical documentation confirming compliance with the requirements of assisted reproductive methods and technologies | ||
40. |
Availability of an entry in the medical documentation confirming the performance of the following functions in the provision of pre-medical care to women during and in the non-pregnant state by secondary medical professionals (obstetricians, paramedics, nurses): | ||
41. |
Availability of an entry in the medical documentation confirming compliance with the requirements for the organization of obstetric and gynecological care at the inpatient level: | ||
Providing medical care to newborns | |||
42. |
Availability of an entry in the medical documentation confirming compliance with the requirements for the organization of medical care for newborns at the inpatient level: | ||
43. |
Availability of an entry in the medical documentation confirming compliance with the requirements of medical care for newborns in third-level medical organizations: | ||
44. | Availability of an entry in the medical documentation confirming compliance with the requirements for providing basic care to a healthy newborn, including prevention of hypothermia in compliance with the "heat chain", skin contact with the mother or skin-to-skin contact, early initiation of breastfeeding during the first hour (if there are signs of the baby's readiness), prevention of nosocomial infections | ||
45. | Availability of an entry in the medical documentation confirming compliance with the requirements of anthropometry of a healthy newborn, its full examination and other measures 2 hours after delivery | ||
46. | Availability of an entry in the medical documentation confirming compliance with the requirements for emergency medical care in case of detection of disorders of the newborn's condition, according to indications, transfer to the intensive care unit or the neonatal intensive care unit | ||
47. |
Availability of an entry in the medical documentation confirming compliance with the requirements for monitoring the mother and a healthy newborn in the maternity ward by an obstetrician within two hours after birth: | ||
48. | Availability of an entry in the medical documentation confirming compliance with the transfer 2 hours after the birth of a healthy newborn with his mother to the department of joint stay of mother and child | ||
49. | Availability of an entry in the medical documentation confirming the round-the-clock supervision by medical personnel and the constant participation of the mother in the care of the child, with the exception of cases of moderate and severe conditions of the mother in the postpartum department in the wards of mother and child joint stay | ||
50. | Availability of an entry in the medical documentation confirming compliance with the requirements for dynamic monitoring of a newborn with timely detection of disorders of the newborn's condition, conducting the necessary examination, examination by the head of the department, and organizing a consultation to clarify management tactics. Provision of emergency medical care, timely transfer to the intensive care unit or neonatal intensive care unit | ||
51. |
Availability of an entry in the medical documentation confirming compliance with the requirements by medical professionals in the wards of mother and child joint stay: | ||
52. | Availability of an entry in the medical documentation confirming the daily examination of newborns by a neonatologist, consultations of mothers on the issues of care, prevention of hypothermia and vaccination | ||
53. | Availability of an entry in the medical documentation confirming compliance with the requirements for the organization of consultations by profile specialists, with the implementation of therapeutic and diagnostic measures and the provision of recommendations to the mother on examination, treatment and rehabilitation in the presence of three or more developmental microanomalias or the detection of congenital pathology of newborns | ||
54. | Availability of an entry in the medical documentation confirming compliance with the requirements of medical care in case of emergency in a newborn (asphyxia, respiratory distress syndrome, and others) stabilization of his condition and determination of the degree of readiness for transportation with his mother to the organization of obstetric care of the second or third levels | ||
55. | Availability of an entry in the medical documentation confirming the vaccination of newborns on the basis of the voluntary informed consent of the parents (mother, father or legal representatives) to carry out preventive vaccinations at the time of preventive vaccinations in the Republic of Kazakhstan | ||
56. | Availability of an entry in the medical documentation confirming compliance with the requirements for neonatal screening for phenylketonuria, congenital hypothyroidism and audiological screening for all newborns before discharge | ||
57. | Availability of an entry in the medical documentation confirming compliance with the requirements for a neonatologist to assess the severity of the condition, stabilize the condition, assess the degree of readiness for transportation in case of emergency in a newborn, and arrange for his transfer with his mother (in consultation with an obstetrician-gynecologist) to a second- or third-level medical organization | ||
58. | Availability of an entry in the medical documentation confirming compliance with the requirements in case of suspicion and (or) detection of acute surgical pathology in a newborn, and an emergency consultation with a doctor specializing in Pediatric Surgery (neonatal Surgery). After stabilization of vital signs, the newborn must be transferred to the surgical department of another medical organization (children's or multidisciplinary hospital) or to the neonatal (or pediatric) surgical department, if it is present in the structure of the maternity medical organization, to provide him with appropriate specialized medical care. | ||
59. | Availability of an entry in the medical documentation confirming compliance with the requirements for transfer to a pediatric hospital of full-term newborns after reaching the age of 28 days or premature newborns after reaching the postconceptual age of 42 weeks who need further round-the-clock medical supervision | ||
60. | Availability of mandatory pathoanatomical examination of the fetus and placenta during termination of pregnancy for medical reasons in case of suspected congenital malformations in the fetus | ||
61. | Availability of an entry in the medical documentation confirming the clinical and pathoanatomical analysis of all cases of maternal and infant death after completion of the entire complex of pathoanatomical studies | ||
62. | Availability of a contract for the provision of paid medical services in healthcare organizations. Availability of documents confirming the fact of co-payment | ||
63. | Availability of an entry in the medical documentation confirming the consultation of a pediatric cardiologist (cardiac surgeon) in case of detection of a congenital malformation of the cardiovascular system in maternity organizations, and, if there are medical indications, the transfer of a newborn to a specialized hospital. | ||
64. | Availability of an entry in the medical documentation confirming the use of consulting opportunities with relevant republican organizations through the telemedicine network in case of difficulty in verifying the child's diagnosis and determining management tactics. If necessary, transfer the child to specialized republican organizations | ||
65. |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical certificates) on the conduct of a clinical audit by the Patient Support Service and internal expertise and its assessment according to the following criteria: | ||
66. | Maintaining forms of accounting documentation in the field of healthcare (form № 048/u "Exchange card of pregnant and woman in labor", form № 002/u "Protocol (card) of pathoanatomic examination № ____", form № 077/u "Individual card of pregnant and woman in labor" and others) in electronic and (or) in paper format | ||
67. | Maintaining the Journal of events in information systems (correction, addition, deletion of records), in order to track the chronology of medical care events | ||
Official (s) _____________________________ ______________
position signature
__________________________________________________________________
last name, first name, patronymic (if any)
Head of the entity of control ________________________ ______________
position signature
__________________________________________________________________
last name, first name, patronymic (if any)
The Checklist
Footnote. Appendix 5 - as amended by the joint order of the Acting Minister of Health of the Republic of Kazakhstan dated 31.03.2025 № 27 and Deputy Prime Minister - Minister of National Economy of the Republic of Kazakhstan dated 07.04.2025 № 16 (effective ten calendar days after the date of its first official publication).
in the field of medical services (aid)
________________________________________________________________________
in accordance with article 138
________________________________________________________________________
The Entrepreneural Code of the Republic of Kazakhstan
in relation to entities (objects) providing cardiology, cardiac surgical care
the name of a homogeneous group of entities (objects) of control
________________________________________________________________________
The state body that appointed
the inspection/preventive control with
a visit to the entity (object) of control _________________________________
________________________________________________________________________
An act on the appointment of an inspection/preventive control with a visit to the entity (object
of) control _______________________________________________________
________________________________________________________________ №, date
Name of the entity (object) of control __________________________________
________________________________________________________________________
(Individual identification number), business identification number of the entity (object) of
control ______________________________________________
_______________________________________________________________________
Location address __________________________________________________
____________________________________________________________________
№ | List of requirements | Meet the requirements | Do not meet the requirements | |
1 | 2 | 3 | 4 | |
1. | Availability of documentation confirming the provision of medical care included in the guaranteed amount of free medical care and (or) the system of compulsory social health insurance on a free basis | |||
2. | Availability of a signed contract of co-insurance of professional liability of medical workers | |||
3. | Availability of medical documentation on the compliance of the performed therapeutic and diagnostic measures with the recommendations of the clinical protocols | |||
4. | Availability of written voluntary consent of the patient or his legal representative for invasive interventions and for carrying out medical and diagnostic measures | |||
5. | Availability of medical documentation ("Emergency medical team call card" form № 085/u, "Admission and refusal log", "Inpatient medical record" form №001/u) confirming the arrival of the ambulance station team at the emergency medical services department at the PHC organization or at the hospital admission department, not exceeding 10 minutes (time for transfer of the patient to the doctor of the emergency department) from the moment of its arrival at the hospital, except in cases of emergency medical care | |||
6. |
Availability of an entry in the medical documentation confirming the patient's admission to the hospital's emergency department, with an initial assessment and medical triage (hereinafter referred to as medical triage) in a certain group, based on the patient's condition, its possible deterioration and the priority of emergency medical care. | |||
7. | Availability of an entry in the medical documentation on ensuring the hospitalization of a serious patient in need of constant monitoring of vital functions for medical reasons, by decision of the council and notification of the heads of healthcare organizations, followed by transfer to another medical organization according to the disease profile for further examination and treatment after stabilization of the condition. | |||
8. |
Availability of a medical report with a written justification for the refusal in the absence of indications for hospitalization to a healthcare organization, the doctor of the admission department issues it to the patient. | |||
9. |
Availability of medical documentation confirming indications for hospitalization: | |||
10. | Availability of an entry in the medical documentation confirming the examination of serious patients by the head of the department on the day of hospitalization, and subsequently - on a daily basis. Patients in moderate condition are examined at least once a week. The results of the patient's examination are recorded in the medical record with recommendations on further patient management tactics, with mandatory identification of the medical professional making the entries. | |||
11. | Availability of medical documentation confirming the establishment of the main diagnosis in case of emergency conditions within 24 (twenty-four) hours from the moment the patient is admitted to the round-the-clock hospital based on clinical and anamnestic examination data, results of instrumental and laboratory research methods with entry in the inpatient's medical record in form № 001/u, in stable patients - the presence of an established clinical diagnosis together with the head of the department no later than three calendar days from the date of the patient's admission to the healthcare organization | |||
12. |
Availability of an entry in the medical documentation confirming the planned hospitalization in the presence of indicators: | |||
13. |
Availability of an entry in the medical documentation confirming the conduct of an emergency (around the clock, including on weekends and holidays) procedure, in particular: | |||
14. | Availability of an entry in the medical documentation confirming hospitalization to the catheterization laboratory, bypassing the emergency department, Intensive Care Unit and, if the patient is diagnosed with acute coronary syndrome with segment elevation, acute myocardial infarction | |||
15. |
The presence of an entry in the medical documentation confirming the daily examination of the attending physician of patients in the hospital, except weekends and holidays. During the examination and appointment of additional diagnostic and therapeutic manipulations by the doctor on duty, appropriate entries are made in the medical record. | |||
16. | Availability of an entry in the medical documentation confirming the assessment of the complexity of surgical interventions for congenital heart defects according to the basic Aristotle scale and the effectiveness of operations in the cardiac surgery department | |||
17. |
Availability of an entry in the medical documentation confirming the compliance of medical care for patients with acute coronary syndrome and (or) acute myocardial infarction by level of regionalization: | |||
18. |
Availability of an entry in the medical documentation confirming compliance with the requirements for planned hospitalization: | |||
19. | Availability of an entry in the medical documentation confirming the conduct of consultations or council in case of difficulty in identifying the diagnosis, ineffectiveness of the treatment, as well as other indications | |||
20. |
Availability of an entry in the medical documentation confirming the provision of cardiological (cardiac surgery) care in an inpatient setting, including: | |||
21. | Availability of an entry in the medical documentation on the issuance of a discharge epicrisis to the patient upon discharge, indicating the full clinical diagnosis, the amount of diagnostic studies performed, therapeutic measures, and recommendations for further follow-up and treatment. Discharge data is entered into information systems day by day, indicating the actual time of discharge. | |||
22. |
Availability of an entry in the medical documentation on compliance with the criteria at discharge, in particular: | |||
23. | Availability of a contract for the provision of paid medical services in healthcare organizations. Availability of documents confirming the fact of co-payment | |||
24. | Availability of an informed written consent of the patient for transfusion of blood and its components | |||
25. | Availability of an entry in the medical documentation (form № 001/u "Inpatient medical record") confirming the examination of the recipient before transfusion for markers of hemotransmissive infections (HIV, hepatitis B and C), as well as recommendations in the discharge epicrisis on the need for repeated examination for HIV and hepatitis B and C in the PHC organization at the place of attachment after 1, 3, 6 months | |||
26. | Availability of a contract in a medical organization for the purchase and delivery of blood and its components | |||
27. | Availability of documentation (an internal document approved by the first supervisor) confirming the distribution of functions of employees involved in each stage of blood transfusion and its components | |||
28. | Availability of an entry in the medical documentation (the result of a group study using the ABO system and Rhesus affiliation, screening of irregular antierythrocyte antibodies in form 098/u or an entry in electronic form 001/u "Hospital patient's medical record") confirming the immunohematological examination of recipients to ensure the safety of transfusion therapy | |||
29. | Availability of an entry in the medical documentation confirming the establishment of indications for the appointment of blood and its components based on clinical manifestations of deficiency or dysfunction of cellular or other blood components, confirmed by laboratory data ("Pretransfusion epicrisis" addendum 6 to the inpatient patient's medical record form 001/u) | |||
30. | Availability of documentation (an internal document approved by the first supervisor) confirming continuous training of personnel involved in transfusion therapy and admission to transfusion care for medical personnel and mid-level medical personnel | |||
31. | Availability of medical documentation confirming the transfer of assets from the hospital to the PHC for patients who underwent hemotransfusion | |||
32. | Availability of medical documentation ("Diary" insert sheet 2 to the medical record of inpatient patient f 001/u) confirming the control of the effectiveness of blood transfusion and its components | |||
33. | Maintaining forms of accounting documentation in the field of healthcare (form № 003/u "Form of accounting for the movement of blood, its components and diagnostic standards" on electronic and (or) paper media; Insert sheet 6 to the inpatient patient's medical record form 001/u "Pretransfusion epicrisis", "Protocol of transfusion of components", "Transfusion sheet", Form № 006/u "Registration form for blood transfusion, its components, preparations", Form № 007/u "Registration form for blood recipients and its components") on electronic and (or) paper media | |||
34. |
Availability of an entry in the medical documentation confirming the examination of persons for clinical indications of HIV infection in the detection of diseases, syndromes and symptoms: | |||
35. |
Availability of an entry in the medical documentation confirming compliance with the requirements of the examination of temporary disability, the issuance of a sheet and a certificate of temporary disability (form №001/u "Medical record of an inpatient patient", form 052/u "Medical record of an outpatient patient", extracts of sheets on temporary disability of patients, form № 025/u "Journal for recording conclusions of the medical advisory commission", form № 029/u "Book of registration of temporary disability sheets", form № 037/u "Certificate №__________ on the temporary disability of a student of college, vocational school, on illness, quarantine and other reasons for the absence of a child attending school, preschool organization (underline)", form № 038/u "Certificate № ______ of temporary disability" and others): | |||
36. |
Availability of documentation confirming compliance with the requirements for the organization and conduct of the MAC: | |||
37. |
Availability of an entry in the medical documentation confirming the indications for admission to a day hospital at outpatient health organizations and to a hospital at home: | |||
38. | Availability of a rehabilitation department in a medical organization | |||
39. | Availability of a cardiology office in the structure of organizations providing outpatient care to the population (district, city, region, republic) and organizations providing inpatient care | |||
40. | Availability of documentation confirming the referral of the patient to a clinical diagnostic center for the provision of consultative and diagnostic assistance if it is impossible to establish a diagnosis of CVD in the PHC organization, with consultation, if necessary, involving profile specialists, including consultants from medical organizations at the republican level | |||
41. | Availability of an entry in the medical documentation confirming the provision of consultative and diagnostic assistance to a patient with CVD by a profile specialist at the referral of a PHC specialist or other profile specialist | |||
42. | Availability in the medical documentation of an opinion on the preparation of documents for referral to the MSE in the presence of high blood pressure (crisis course), arrhythmias of various origins, increased frequency of angina attacks and increasing symptoms of heart failure, issuance and prolongation of a sheet or certificate of temporary disability, and in case of permanent disability (condition after a myocardial infarction, aorta-coronary bypass surgery, congestive heart failure) | |||
43. | Availability of medical documentation confirming the implementation of therapeutic and diagnostic measures, drug provision, organization of therapeutic nutrition and appropriate patient care from the moment of admission to the healthcare organization | |||
44. | Availability of medical documentation confirming the use of consulting opportunities with relevant republican organizations through a telemedicine network in case of difficulty in verifying the patient's diagnosis and determining management tactics. If necessary, the patient is transferred to specialized republican organizations. | |||
45. | Availability of an entry in the medical documentation confirming the provision of supportive care (support for adequate feeding, maintenance of water balance, pain control, fever management, oxygen therapy) | |||
46. |
Availability of an entry in the medical documentation confirming the provision of the following therapeutic and diagnostic measures within the framework of PHC: | |||
47. | Availability of medical documentation confirming the use of alternative treatment methods with less painful ones, which are not inferior in effectiveness, in order to avoid unjustified painful procedures. | |||
48. |
Availability of an entry in the medical documentation confirming compliance with the requirements for providing anesthesiological and intensive care: | |||
49. |
Availability of documentation confirming compliance with the actions during the autopsy: | |||
50. | Availability of a written statement from the spouse, close relatives or legal representatives of the deceased, or a written statement of the will given by the person during his lifetime to release the corpse without conducting a pathoanatomic autopsy, in the absence of suspicion of violent death. | |||
51. |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical certificates) confirming the conduct of a clinical audit by the patient support service and internal expertise, and its assessment according to the following criteria: | |||
52. | Availability of an entry in the medical documentation confirming the examination of the patient by a doctor in the emergency department of the hospital with the written consent of the patient or his legal representative to provide him with medical care | |||
53. | Availability of an entry in the medical documentation confirming the provision by a cardiologist (cardiac surgeon) of an advisory and diagnostic opinion in form № 075/u, which indicates the results of the examination and treatment, as well as the further treatment of a patient with DCS to a PHC doctor who referred the patient for consulting services in the provision of consultative and diagnostic assistance | |||
54. | Availability of an entry in the medical documentation on the issuance and/ or prolongation of a sheet or certificate of temporary disability by a cardiologist of a medical organization to a patient in the presence of abnormalities in blood pressure (crisis course), arrhythmias of various origins, increased angina attacks and increased symptoms of heart failure, and in case of persistent disability of the patient (condition after a myocardial infarction, coronary artery bypass grafting, congestive heart failure) – a conclusion on submission of documents for referral to the MSE | |||
55. | Availability of medical documentation confirming the hospitalization of a patient with DCS in an emergency Intensive Care Unit, bypassing the emergency department in case of a life threat | |||
56. | Availability of an entry in the medical documentation confirming the hospitalization of a patient with an established diagnosis of acute coronary syndrome (hereinafter referred to as ACS) with elevation of the segment, acute myocardial infarction (hereinafter referred to as AMI) to the catheterization laboratory, bypassing the emergency department, Intensive Care Unit. | |||
57. |
Availability of an entry in the medical documentation confirming the provision of cardiological (cardiac surgery) care in an inpatient setting, including: | |||
58. | Availability of an entry in the medical documentation confirming the immediate transfer of a patient undergoing treatment in a medical organization without the possibility of artificial ventilation (hereinafter referred to as AV), if he has indications for emergency interventional or cardiac surgery, by ambulance, including medical aircraft in a medical organization with the possibility of AV around the clock | |||
59. |
Availability of an entry in the medical documentation confirming the implementation of surgical interventions in cardiac surgery according to the principle of regionalization, taking into account the level of complexity: |
Official (s) ______________________________ ______________
position signature
___________________________________________________________________
last name, first name, patronymic (if any)
Head of the entity of control ________________________ ______________
position signature
____________________________________________________________________
last name, first name, patronymic (if any)
The Checklist
Footnote. Appendix 6 - as amended by the joint order of the Acting Minister of Health of the Republic of Kazakhstan dated 31.03.2025 № 27 and Deputy Prime Minister - Minister of National Economy of the Republic of Kazakhstan dated 07.04.2025 № 16 (effective ten calendar days after the date of its first official publication).
in the field of medical services (aid)
________________________________________________________________________
in accordance with article 138
_______________________________________________________________________
The Entrepreneurial Code of the Republic of Kazakhstan in relation to entities (objects)
providing hemodialysis care
________________________________________________________________________
name of a homogeneous group of entities (objects) of control
_______________________________________________________________________
The state body that appointed the inspection/preventive control
with a visit to the entity (object) of control ___________________________________
________________________________________________________________________
An act on the appointment of an inspection/preventive control with a visit to the entity (object
of) control _______________________________________________________
_______________________________________________________________ №, date
Name of the entity (object) of control __________________________________
________________________________________________________________________
(Individual identification number), business identification
number of the entity (object) of control
_______________________________________________
________________________________________________________________________
Location address __________________________________________________
________________________________________________________________________
_________________________________________________________________
№ | List of requirements | Meet the requirements | Do not meet the requirements |
1 | 2 | 3 | 4 |
1 | Availability of a written voluntary consent of the patient or his legal representative for invasive interventions and for carrying out medical and diagnostic measures | ||
2 | Availability of a signed contract of co-insurance of professional liability of medical workers | ||
3 | Availability of a conclusion on the compliance of a healthcare entity with the provision of high-tech medical services | ||
4 | Availability of supporting documentation on the compliance of the performed therapeutic and diagnostic measures with the recommendations of the clinical protocols | ||
5 |
Availability of an entry in the medical documentation confirming the indications for a planned transfer to program renal replacement therapy is the level of glomerular filtration rate (hereinafter referred to as GFR): | ||
6 |
Availability of an entry in the medical documentation confirming compliance with the absolute indications for emergency renal replacement therapy in patients with stage 4-5 CKD and/or suspected AKI is: | ||
7 | Availability of documentation confirming the compliance of the hemodialysis machine with quality certificates, with sufficient resource and performance provided by the manufacturing country | ||
8 |
Availability of documentation confirming compliance with the algorithm of hemodialysis procedure: | ||
9 | Availability of an entry in the medical documentation confirming the provision of medicines and supplies according to the dialysis protocol | ||
10 | Availability of a water treatment system and compliance with the requirements for the preparation of hemodialysis fluids, the quality of hemodialysis solutions and a blood purification system | ||
11 | Availability of a contract for the provision of paid medical services in healthcare organizations. Availability of documents confirming the fact of co-payment | ||
12 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical certificates) on the conduct of a clinical audit by the patient support service and internal expertise and its assessment according to the following criteria: | ||
13 | Availability of documentation confirming the provision of medical care included in the guaranteed amount of free medical care and (or) the system of compulsory social health insurance on a free basis |
Official (s) ______________________________ ______________
position signature
____________________________________________________________________
last name, first name, patronymic (if any)
Head of the entity of control _________________________ ______________
position signature
____________________________________________________________________
last name, first name, patronymic (if any)
| Annex 7 to the joint order of the Minister of healthcare of the Republic of Kazakhstan dated November 15, 2018 № KR DSM-32 and Minister of national economy of the Republic of Kazakhstan dated November 15, 2018 № 70 |
The Checklist
Footnote. Appendix 7 - as amended by the joint order of the Acting Minister of Health of the Republic of Kazakhstan dated 31.03.2025 № 27 and Deputy Prime Minister - Minister of National Economy of the Republic of Kazakhstan dated 07.04.2025 № 16 (effective ten calendar days after the date of its first official publication).
in the field of medical services (aid)
________________________________________________________________________
in accordance with article 138
_______________________________________________________________________
The Entrepreneurial Code of the Republic of Kazakhstan in
relation to entities (objects) providing dental care
_______________________________________________________________________
name of a homogeneous group of entities (objects) of control
_______________________________________________________________________
The state body that appointed the inspection/preventive control
with a visit to the entity (object) of control ___________________________________
________________________________________________________________________
An act on the appointment of an inspection/preventive control with a visit to the entity (object
of) control _______________________________________________________
_______________________________________________________________ №, date
Name of the entity (object) of control __________________________________
_______________________________________________________________________
(Individual identification number), business identification
number of the entity (object) of control
_______________________________________________
_______________________________________________________________________
Location address __________________________________________________
________________________________________________________________________
_______________________________________________________________________
№ | List of requirements | Meet the requirements | Do not meet the requirements |
1 | 2 | 3 | 4 |
1 | Availability of documentation confirming the provision of medical care included in the guaranteed amount of free medical care and (or) the system of compulsory social health insurance on a free basis | 1 | 2 |
2 | Availability of a signed contract of co-insurance of professional liability of medical workers | ||
3 |
Availability of an entry in the medical documentation confirming compliance with the requirements of dental care: | ||
4 | Availability of a contract for the provision of paid services in healthcare organizations. | ||
5 | Availability of an entry in the medical documentation confirming compliance with clinical diagnostic studies on the levels of dental care | ||
6 | Availability of form № 058/u "Dental patient's medical record (including sanitation)" for each patient | ||
7 | Availability of an entry in the medical documentation confirming the implementation of therapeutic and diagnostic measures in accordance with the recommendations of clinical protocols, in the absence of clinical protocols, according to international standards and guidelines based on evidence-based medicine. | ||
8 | Maintaining forms of accounting documentation in the field of healthcare (Form № 058/u "Dental patient's medical record (including sanitation) № ___" Summary statement of daily accounting of the dentist's work for therapeutic and surgical receptions of dental organizations of all forms of ownership and others) on electronic and (or) paper media by profile specialists working in healthcare organizations that provide dental care | ||
9 | Availability of an entry in the medical documentation confirming the provision of dental care (electronic medical records, related materials on the patient's health status and diagnosis), including in the MIS for each tooth in the examination card of baby teeth and the examination card of permanent teeth | ||
10 | Availability of an entry in the medical documentation confirming the determination of the patient's allergic status before dental interventions requiring local anesthesia, and, according to the indications, referral of the patient to PHC organizations or medical organizations for laboratory examination in order to identify drug allergies | ||
11 |
The presence of an entry in the medical documentation confirming the provision of dental care to children on an outpatient basis in the form of consultative and diagnostic assistance at a referral and self-referral, including: | ||
12 | Availability of an informed consent of parents or representatives when carrying out dental interventions for children associated with the risk of pain, manipulations are carried out according to indications using anesthesia (local, sedation, general) | ||
13 | Availability of medical documentation confirming the provision of dental care in inpatient settings by maxillofacial surgeons and includes the prevention, diagnosis, treatment of diseases and conditions requiring the use of special medical methods and technologies, as well as medical rehabilitation | ||
14 | Availability of medical documentation confirming the holding of a consultation or the use of remote medical services in the differential diagnosis of complex, unclear cases to verify the diagnosis | ||
15 | Availability of medical documentation confirming the dynamic monitoring and dental examination of children aged 0 to 17 years inclusive and pregnant women | ||
16 | Availability of medical documentation confirming the provision of preventive measures for pregnant women and adults, which includes monitoring the hygienic condition of the oral cavity, dental cleaning instruction, selection of oral hygiene products and items, professional oral hygiene, oral sanitation (using modern materials and technologies), information and explanatory work on risk factors of occurrence of dental diseases is carried out along the route of the primary preventive examination of a pregnant woman | ||
17 |
Availability of documentation confirming compliance with the requirements for the organization and conduct of the MAC: | ||
18 |
Availability of an entry in the medical documentation confirming compliance with the requirements for the examination of temporary disability, the issuance of a sheet and a certificate of temporary disability (form №001/u "Medical record of an inpatient patient", form 052/u "Medical record of an outpatient patient", extracts of sheets on temporary disability of patients, form № 025/u "Journal to record the conclusions of the medical advisory commission", form № 029/u "Book of registration of sheets on temporary disability", form № 037/u "Certificate № _____ on temporary disability of a student, student of college, vocational school, on illness, quarantine and other reasons for the absence of a child attending school, preschool organization (please underline)", form № 038/u "Certificate № ______ of temporary disability" and others): | ||
19 | Availability of a written voluntary consent of the patient or his legal representative for invasive interventions and for carrying out medical and diagnostic measures | ||
20 |
Availability of an entry in the medical documentation confirming compliance with the requirements for providing anesthesiological and intensive care: | ||
21 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical certificates) on the conduct of a clinical audit by the patient support service and internal expertise and its assessment according to the following criteria: |
Official (s) ______________________________ ______________
position signature
____________________________________________________________________
last name, first name, patronymic (if any)
Head of the entity of control _________________________ ______________
position signature
____________________________________________________________________
last name, first name, patronymic (if any)
| Appendix 8 to the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated November 15, 2018, № ҚР ДСМ-32 and the Minister of National Economy of the Republic of Kazakhstan dated November 15, 2018, № 70 |
Checklist
Footnote. Appendix 8 - as amended by the joint order of the Acting Minister of Healthcare of the Republic of Kazakhstan dated 31.03.2025 № 27 and the Deputy Prime Minister - Minister of National Economy of the Republic of Kazakhstan dated 07.04.2025 № 16 (shall come into effect upon expiry of ten calendar days after the date of its first official publication).
in the field of providing medical services (assistance)
________________________________________________________________________
in accordance with Article 138
______________________________________________________________________
of the Entrepreneurial Code of the Republic of Kazakhstan
in relation to _ entities (objects) providing tuberculosis care
______________________________________________________________________
name of a homogeneous group of entities (objects) of control
______________________________________________________________________
State body that has appointed an inspection/preventive control
with a visit to the entity (object) of control
______________________________________________________________________
_______________________________________________________________________
Act on the appointment of an inspection/preventive control with a visit to the entity
(object) of control ________________________________________________________
________________________________________________________________№, date
Name of the entity (object) of control _________________________________________
_______________________________________________________________________
(Individual identification number), business identification number
of the entity (object) of control ______________________________________________
_______________________________________________________________________
Address of location _______________________________________________________
_______________________________________________________________________
_______________________________________________________________________
№ | List of requirements | Complies with the requirements | Does not comply with the requirements |
1 | 2 | 3 | 4 |
Provision of anti-tuberculosis care at the outpatient and polyclinic level | |||
1 | Availability of documentation confirming the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social medical insurance on a free basis. | ||
2 | Availability of a concluded co-insurance agreement for the professional liability of medical workers | ||
3 |
Availability of documentation confirming the implementation of the following activities by primary health care specialists: | ||
4 | Availability of documentation confirming examination of a patient with suspected tuberculosis in organizations providing primary health care under this scheme | ||
5 | Availability of medical documentation confirming the detection of tuberculosis by fluorography among the target population group with a high risk of the disease and subject to mandatory annual fluorographic examination | ||
6 | Availability of documentation confirming the organization of directly observed treatment rooms (hereinafter referred to as DOT) in PHC organizations for outpatient treatment. The patient shall receive and take medications in the DOT room under the supervision of a responsible medical worker. Once every 10 days, patients undergoing directly observed treatment shall be examined by a PHC physician/polyclinic TB specialist, more often if indicated. Patients living in rural areas shall be examined by a TB specialist once a month | ||
7 |
Presence of a record in the medical documentation confirming the assessment of the clinical condition of a patient receiving anti-tuberculosis treatment for the presence of adverse reactions and events, carried out daily by the attending physician or TB doctor, a medical worker of the directly observed treatment office. The medical worker who has identified adverse reactions and events to the drug shall fill out a report card and make a record in the patient's medical documentation. | ||
8 | Presence of records of the movement of anti-tuberculosis drugs at the outpatient level in the registration log of anti-tuberculosis drugs | ||
9 | Presence of a record in the medical documentation of a conversation with the patient (parents or guardians of children) before the start of treatment about the need for a full course of chemotherapy, followed by the signing of informed consent | ||
10 | Availability of medical documentation confirming registration and dispensary observation of tuberculosis patients in organizations providing primary health care at the place of actual residence, work, study or military service, regardless of registration | ||
11 |
Availability of documentation confirming compliance with the requirements for organizing and conducting the MCC: | ||
12 |
Availability of medical documentation confirming the compliance of the levels of medical rehabilitation provided to patients: | ||
Provision of anti-tuberculosis care at the inpatient level | |||
13 | Availability of documentation confirming the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social medical insurance on a free basis | ||
14 | Availability of a concluded co-insurance agreement for the professional liability of medical workers | ||
15 |
Distribution of patients in departments by wards, taking into account laboratory test data and drug sensitivity at the time of admission and during treatment. | ||
16 |
Presence of a record in the medical documentation confirming daily examination of patients in the hospital by a tuberculosis specialist. | ||
17 | Presence of a record in the medical documentation confirming the organization of a consultation in difficult situations to verify the diagnosis and determine treatment tactics with the participation of specialists at the regional and national levels, in person or remotely via telemedicine | ||
18 | Presence of records of movement of anti-tuberculosis drugs at the inpatient level in the registration log of anti-tuberculosis drugs | ||
19 |
Presence of a record in the medical documentation confirming compliance with the criteria for discharging a patient with tuberculosis from the hospital: | ||
20 | Availability of written voluntary consent of the patient or his/her legal representative for invasive interventions and the implementation of treatment and diagnostic measures | ||
21 | Presence of a record in the medical documentation confirming the examination of severe patients by the head of the department on the day of hospitalization, and subsequently, daily. Patients in moderate condition shall be examined at least once a week. The results of the patient's examination shall be recorded in the medical record with recommendations for further patient management tactics, with mandatory identification of the medical worker making the records | ||
22 | Presence of a record in the medical documentation confirming the establishment of a clinical diagnosis, jointly with the head of the department, no later than three calendar days from the date of the patient's hospitalization in the healthcare organization | ||
23 | Presence of a record in the medical documentation confirming the holding of consultations or a council in case of difficulty in identifying the diagnosis, the ineffectiveness of the treatment, as well as for other indications | ||
24 | Presence of a record in the medical documentation on the issuance of a discharge summary to the patient upon discharge, indicating the full clinical diagnosis, the scope of diagnostic studies performed, treatment measures and recommendations for further observation and treatment. Discharge data shall be entered into information systems on the same day, indicating the actual time of discharge | ||
25 |
Presence of a record in the medical documentation confirming compliance with the requirements for the provision of anesthetic and resuscitation care: | ||
26 | Availability of informed written consent from the patient for transfusion of blood and its components | ||
27 | Presence of a record in the medical documentation (form № 001/у "Medical record of an inpatient") confirming the examination of the recipient before the transfusion for markers of blood-borne infections (HIV, hepatitis B and C), as well as recommendations in the discharge summary on the need for repeated testing for HIV and hepatitis B and C in the primary health care organization at the place of attachment after 1, 3, 6 months | ||
28 | Availability of a contract with the medical organization for the purchase and delivery of blood and its components | ||
29 | Availability of documentation (internal document approved by the first head) confirming the distribution of functions of employees involved in each stage of blood transfusion and its components | ||
30 | Presence of a record in the medical documentation (result of a group study on the ABO system and Rh factor, screening of irregular anti-erythrocyte antibodies according to form 098/у or a record in the electronic form 001/у "Medical record of an inpatient"), confirming the immunohematological examination of recipients to ensure the safety of transfusion therapy | ||
31 | Presence of a record in the medical documentation confirming the establishment of indications for the administration of blood, its components based on clinical manifestations of deficiency or dysfunction of cellular or other blood components, confirmed by laboratory data ("Pre-transfusion epicrisis" insert sheet 6 to the medical record of an inpatient, form 001/у) | ||
32 | Availability of documentation (internal document approved by the first head) confirming continuous training of personnel involved in transfusion therapy and admission to transfusion care of medical personnel and mid-level medical personnel | ||
33 | Availability of medical documentation confirming the transfer of assets from the hospital to the emergency medical care facility for patients who have undergone a blood transfusion | ||
34 | Availability of medical documentation ("Diary", insert sheet 2 to the medical record of an inpatient f 001/у), confirming control over the effectiveness of blood transfusion and its components | ||
35 | Maintaining forms of accounting documentation in the field of healthcare (Form № 003/у "Form for recording the movement of blood, its components and diagnostic standards" on electronic and (or) paper; Insert sheet 6 to the medical record of an inpatient, Form 001/у " Pre-transfusion epicrisis", "Protocol for transfusion of components", " Transfusion sheet", Form № 006/у "Form for recording transfusion of blood, its components, drugs", Form № 007/у "Form for recording recipients of blood and its components") on electronic and (or) paper | ||
36 |
Availability of documentation confirming the examination of individuals for clinical indications for HIV infection when the following diseases, syndromes and symptoms are detected: | ||
37 |
Presence of a record in the medical documentation confirming compliance with the requirements for examining temporary disability, issuing a sheet and a certificate of temporary disability (form № 001/y "Inpatient Medical Record", form 052/y "Outpatient Medical Record", stubs of sheets of temporary disability of patients, form № 025/y "Journal for recording the conclusions of the medical advisory commission", form № 029/y "Registration book of sheets of temporary disability", form № 037/y "Certificate № __________ on temporary disability of a student, college student, vocational school, illness, quarantine and other reasons for the absence of a child attending school, preschool organization (underline as appropriate)", form № 038/y "Certificate № ______ on temporary disability" and others): | ||
38 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical reports) on the clinical audit conducted by the Patient Support Service and internal expertise and its assessment according to the following criteria: | ||
39 |
Availability of documentation confirming compliance with the actions during the pathological autopsy: | ||
40 | Availability of a written statement from the spouse, close relatives or legal representatives of the deceased, or a written expression of will given by the person during his/her lifetime for the extradition of the body without conducting a pathological autopsy, in the absence of suspicion of violent death | ||
41 | Availability of a contract for the provision of paid medical services in healthcare organizations. Availability of documents establishing the fact of co-payment | ||
42 |
Availability of supporting documentation on the compliance of the levels of medical rehabilitation provided to patients: | ||
43 | Presence of a record in the medical documentation confirming the collection of biological materials to determine the content of a psychoactive substance with the recording of the results in the medical record when signs of psychoactive substance use are detected during an appeal for medical assistance to a healthcare organization without issuing a medical examination report to establish the fact of psychoactive substance use and the state of intoxication | ||
44 | Availability of supporting documentation on the compliance of the treatment and diagnostic measures with the recommendations of clinical protocols. | ||
Official(s) ________________________________ ____________
position signature_______________________________________
surname, first name, patronymic (if any)
Head of the subject of control _________________ ____________
position signature________________________________________
surname, first name, patronymic (if any)
| Appendix 9 to the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated November 15, 2018, № ҚР ДСМ-32 and the Minister of National Economy of the Republic of Kazakhstan dated November 15, 2018, № 70 |
Checklist
Footnote. Appendix 9 - as amended by the joint order of the Acting Minister of Healthcare of the Republic of Kazakhstan dated 31.03.2025 № 27 and the Deputy Prime Minister - Minister of National Economy of the Republic of Kazakhstan dated 07.04.2025 № 16 (shall come into effect upon expiry of ten calendar days after the date of its first official publication).
in the field of providing medical services (assistance)
________________________________________________________________________
in accordance with Article 138
______________________________________________________________________
of the Entrepreneurial Code of the Republic of Kazakhstan
in relation to _ entities (objects) providing oncological care
______________________________________________________________________
name of a homogeneous group of entities (objects) of control
______________________________________________________________________
State body that has appointed an inspection/preventive control
with a visit to the entity (object) of control
______________________________________________________________________
_______________________________________________________________________
Act on the appointment of an inspection/preventive control with a visit to the entity
(object) of control ________________________________________________________
________________________________________________________________№, date
Name of the entity (object) of control _________________________________________
_______________________________________________________________________
(Individual identification number), business identification number
of the entity (object) of control ______________________________________________
_______________________________________________________________________
Address of location _______________________________________________________
_______________________________________________________________________
_______________________________________________________________________
№ | List of requirements | Complies with the requirements | Does not comply with the requirements |
1 | 2 | 3 | 4 |
Provision of oncological care at the outpatient and polyclinic level | |||
1 | Availability of documentation confirming the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social medical insurance on a free basis | ||
2 | Availability of a concluded co-insurance agreement for professional liability of medical workers | ||
3 |
Availability of documentation confirming the creation of a multidisciplinary team to ensure an individual approach to providing medical care to patients with malignant neoplasms. | ||
4 |
Availability of documentation confirming the holding of meetings of the MDT, with consideration of documents: | ||
5 |
Availability of documentation confirming the organization by primary health care specialists: | ||
6 |
Presence of a record in the medical documentation confirming the provision of CDA, including the following: | ||
7 |
Presence of a record in the medical documentation confirming the referral of the patient's general practitioner to an oncologist or an OCC upon suspicion or detection of a tumor disease. | ||
8 |
Presence of a record in the medical documentation confirming compliance with the requirements for the provision of oncological care in the form of outpatient and polyclinic care: | ||
9 |
Availability of medical documentation confirming the implementation of immunohistochemical and molecular genetic studies to determine the molecular biological characteristics of tumors to individualize patient treatment, as well as to confirm (verify) the diagnosis of cancer. Immunohistochemical studies shall be conducted at the level of pathomorphological laboratories of organizations providing oncological care, secondary level and tertiary level reference centers and shall be carried out according to clinical protocols. | ||
10 | Presence of a record in the medical documentation confirming the conduct of international teleconsultations tumor bio-samples via the telepathology system to clarify the diagnosis in complex clinical cases. The time frame for teleconsultations shall not exceed thirty working days. | ||
11 |
Presence of a record in the medical documentation confirming the display in the MIS of the entire period of examination of patients with suspected malignant neoplasms in outpatient settings, indicating markers of oncoalergic activity within the following examination periods: | ||
12 | Availability of medical documentation confirming specialized treatment of a patient with a malignant neoplasm, initiated no later than thirty calendar days from the date of diagnosis and placement under dynamic observation. | ||
13 |
Availability of medical documentation confirming the implementation of dynamic observation of clinical groups of patients with suspected malignant neoplasms and a confirmed diagnosis of malignant neoplasms: | ||
14 |
Availability of medical documentation confirming lifelong medical dynamic observation of patients with malignant neoplasms in an organization providing medical care on an outpatient basis at the place of attachment - primary level (clinical group III) and organizations providing oncological care at the secondary level (clinical group II) - at the place of residence and attachment. | ||
15 | When a diagnosis of cancer is established for the first time, form № 034/у "Notification" shall be filled out for each patient, which shall be sent within three working days to the organization providing oncological care at the secondary level at the patient’s permanent place of residence for registration in the Electronic Registry of Cancer Patients and registration, indicating the circumstances of the diagnosis (the patient’s self-referral to a primary health care organization, CDA – primary level, the patient’s self-referral to an organization providing oncological care at the secondary and tertiary levels, the diagnosis was established during a screening examination, the diagnosis was established during a preventive examination). | ||
16 |
For each patient with a diagnosis of stage IV malignant neoplasm for the first time in their life and with visually accessible localizations of stage III, a protocol shall be filled out in case of detection of an advanced form of malignant neoplasm in the patient (clinical group V). | ||
17 | Availability of mandatory confidential medical examination for HIV infection of individuals based on clinical and epidemiological indications, including sexual partners of pregnant women, individuals who have applied voluntarily and anonymously | ||
18 |
Presence of a record in the medical documentation confirming compliance with the indications for hospitalization in a day hospital at outpatient and polyclinic healthcare organizations and a home hospital: | ||
19 |
Presence of an entry in the medical documentation confirming compliance with the requirements for the examination of temporary disability, issuance of a sheet and a certificate of temporary disability (form № 001/y "Inpatient Medical Record", form 052/y "Outpatient Medical Record", stubs of sheets of temporary disability of patients, form № 025/y "Journal for recording the conclusions of the medical advisory commission", form № 029/y "Registration book of sheets of temporary disability", form № 037/y "Certificate № ___ on temporary disability of a student, college student, vocational school, on illness, quarantine and other reasons for the absence of a child attending school, preschool organization (underline as appropriate)", form № 038/y "Certificate № _______ on temporary disability" and others): | ||
20 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical reports) on the clinical audit conducted by the patient support service and internal expertise and its assessment according to the following criteria: | ||
Provision of oncological care at the inpatient level | |||
21 | Availability of documentation confirming the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social medical insurance on a free basis | ||
22 | Availability of a concluded co-insurance agreement for professional liability of medical workers | ||
23 |
Availability of medical documentation confirming the dilution of antitumor drugs in the rooms for the centralized dilution of cytostatic drugs (hereinafter referred to as the RCDC) to ensure the safety of medical personnel from the toxic effects of antitumor drugs and the rational use of drugs. | ||
24 |
Presence of a record in the medical documentation confirming the implementation of radiation therapy according to the principle of "a single doctor–radiation therapist (radiation oncologist)", which provides for the clinical management of the patient, the implementation of pre-radiation preparation and radiation treatment by one doctor–radiation therapist (radiation oncologist). | ||
25 |
Availability of medical documentation confirming the implementation of antitumor therapy, radiation and radionuclide therapy, palliative medical care in hospital-substituting conditions for patients with malignant neoplasms in cases that do not require constant medical supervision, in organizations providing oncological care at the secondary and tertiary levels in the departments of chemotherapy, radiation therapy, palliative medical care, medical rehabilitation. | ||
26 | Presence of a record in the medical documentation confirming the hospitalization of a seriously ill patient who requires constant monitoring of vital functions for medical reasons, by decision of the council and notification of the heads of healthcare organizations, followed by transfer to another medical organization according to the profile of the disease for further examination and treatment after stabilization of the condition | ||
27 | Presence of a record in the medical documentation confirming the examination of severe patients by the head of the department on the day of hospitalization, and subsequently, daily. Patients in moderate condition shall be examined at least once a week. The results of the patient's examination shall be recorded in the medical record with recommendations for further patient management tactics with mandatory identification of the medical worker making the records | ||
28 | Presence of a record in the medical documentation confirming the establishment of a clinical diagnosis jointly with the head of the department, no later than three calendar days from the date of the patient's hospitalization in the healthcare organization | ||
29 |
Presence of a record in the medical documentation confirming daily examination of patients in the hospital by the attending physician, except for weekends and holidays. When examining and prescribing additional diagnostic and therapeutic procedures by the doctor on duty, the corresponding records are made in the medical record. If the patient's condition worsens, the doctor on duty shall notify the head of the department and (or) the attending physician, agree on changes to the diagnostic and treatment process, and make a record in the medical record (paper and (or) electronic) version. | ||
30 | Presence of a record in the medical documentation confirming the holding of consultations or a council in case of difficulty in identifying the diagnosis, the ineffectiveness of the treatment, as well as for other indications | ||
31 |
Presence of a record in the medical documentation confirming the examination of individuals for clinical indications for HIV infection when the following diseases, syndromes and symptoms shall be detected: | ||
32 | Availability of a contract for the provision of paid medical services in healthcare organizations. Availability of documents establishing the fact of co-payment | ||
33 |
Presence of a record in the medical documentation confirming compliance with the discharge criteria, in particular: | ||
34 | Presence of a record in the medical documentation on the issuance of a discharge summary to the patient upon discharge, indicating the full clinical diagnosis, the scope of diagnostic studies performed, treatment measures and recommendations for further observation and treatment. Discharge data shall be entered into information systems on the same day, indicating the actual time of discharge | ||
35 | Availability of informed written consent from the patient for transfusion of blood and its components | ||
36 | Presence of a record in the medical documentation (form № 001/у "Medical record of an inpatient") confirming the examination of the recipient before the transfusion for markers of blood-borne infections (HIV, hepatitis B and C), as well as recommendations in the discharge summary on the need for repeated testing for HIV and hepatitis B and C in the primary health care organization at the place of attachment after 1, 3, 6 months | ||
37 | Availability of a contract with the medical organization for the purchase and delivery of blood and its components | ||
38 | Availability of documentation (internal document approved by the first head) confirming the distribution of functions of employees involved in each stage of blood transfusion and its components | ||
39 | Presence of a record in the medical documentation (result of a group study on the ABO system and Rh factor, screening of irregular anti-erythrocyte antibodies according to form 098/у or a record in the electronic form 001/у "Medical record of an inpatient"), confirming the immunohematological examination of recipients to ensure the safety of transfusion therapy | ||
40 | Presence of a record in the medical documentation confirming the establishment of indications for the administration of blood, its components based on clinical manifestations of deficiency or dysfunction of cellular or other blood components, confirmed by laboratory data ("Pre-transfusion epicrisis" insert sheet 6 to the medical record of an inpatient, form 001/у) | ||
41 | Availability of documentation (internal document approved by the first head) confirming continuous training of personnel involved in transfusion therapy and admission to transfusion care of medical personnel and mid-level medical personnel | ||
42 | Availability of medical documentation confirming the transfer of assets from the hospital to the emergency medical care facility for patients who have undergone a blood transfusion | ||
43 | Availability of medical documentation ("Diary", insert sheet 2 to the medical record of an inpatient f 001/у), confirming control over the effectiveness of blood transfusion and its components | ||
44 | Maintaining forms of accounting documentation in the field of healthcare (Form № 003/у "Form for recording the movement of blood, its components and diagnostic standards" on electronic and (or) paper; Insert sheet 6 to the medical record of an inpatient, Form 001/у " Pre-transfusion epicrisis", "Protocol for transfusion of components", " Transfusion sheet", Form № 006/у "Form for recording transfusion of blood, its components, drugs", Form № 007/у "Form for recording recipients of blood and its components") on electronic and (or) paper | ||
45 |
Presence of a record in the medical documentation confirming the determination of the method and tactics of treatment of MDT. | ||
46 | Availability of supporting documentation on the compliance of the medical care provided with clinical protocols | ||
47 |
Presence of an entry in the medical documentation confirming compliance with the requirements for the examination of temporary disability, issuance of a sheet and a certificate of temporary disability (form № 001/y "Inpatient Medical Record", form 052/y "Outpatient Medical Record", stubs of sheets of temporary incapacity for patients, form № 025/y "Journal for recording the conclusions of the medical advisory commission", form № 029/y "Registration book of sheets of temporary disability", form № 037/y "Certificate № __________ on temporary disability of a student, a student of a college, vocational school, on illness, quarantine and other reasons for the absence of a child attending school, a preschool organization (underline as appropriate)", form № 038/y "Certificate № ______ on temporary disability" and others): | ||
48 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical reports) on the clinical audit conducted by the Patient Support Service and internal expertise and its assessment according to the following criteria: | ||
49 |
Presence of a record in the medical documentation confirming compliance with the requirements for conducting a pathological autopsy: | ||
50 | Availability of a written statement from the spouse, close relatives or legal representatives of the deceased, or a written expression of will given by the person during his/her lifetime for the exemption of the body without conducting a pathological autopsy, in the absence of suspicion of violent death | ||
51 |
Availability of medical documentation confirming the provision of oncological care at home: | ||
Official(s) ________________________________ ____________
position signature_______________________________________
surname, first name, patronymic (if any)
Head of the subject of control _________________ ____________
position signature________________________________________
surname, first name, patronymic (if any)
| Appendix 10 to the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated November 15, 2018, № ҚР ДСМ-32 and the Minister of National Economy of the Republic of Kazakhstan dated November 15, 2018, № 70 |
Checklist
Footnote. Appendix 10 - as amended by the joint order of the Acting Minister of Healthcare of the Republic of Kazakhstan dated 31.03.2025 № 27 and the Deputy Prime Minister - Minister of National Economy of the Republic of Kazakhstan dated 07.04.2025 № 16 (shall come into effect upon expiry of ten calendar days after the date of its first official publication).
in the field of providing medical services (assistance)
________________________________________________________________________
in accordance with Article 138
_____________________________________________________________________
of the Entrepreneurial Code of the Republic of Kazakhstan
in relation to _ entities (objects) providing medical and social assistance in the field of mental
health
______________________________________________________________________
name of a homogeneous group of entities (objects) of control
______________________________________________________________________
State body that has appointed an inspection/preventive control
with a visit to the entity (object) of control
______________________________________________________________________
_______________________________________________________________________
Act on the appointment of an inspection/preventive control with a visit to the entity
(object) of control ________________________________________________________
________________________________________________________________№, date
Name of the entity (object) of control _________________________________________
_______________________________________________________________________
(Individual identification number), business identification number
of the entity (object) of control ______________________________________________
_______________________________________________________________________
Address of location _______________________________________________________
_______________________________________________________________________
_______________________________________________________________________
№ | List of requirements | Complies with the requirements | Does not comply with the requirements |
1 | 2 | 3 | 4 |
Requirements for entities (objects) providing medical and social assistance in the field of mental health at the outpatient and polyclinic level | |||
1 | Availability of documentation confirming the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social medical insurance on a free basis | ||
2 | Availability of a concluded co-insurance agreement for professional liability of medical workers | ||
3 |
Availability of medical documentation confirming compliance with the criteria for taking individuals with BMD under dynamic observation: | ||
4 | Availability of medical documentation confirming compliance with the requirement for drug provision to persons with BMD who are under dynamic observation | ||
5 |
Presence of a record in the medical documentation confirming compliance with the requirements for deregistration and transfer to another dynamic observation group: | ||
6 |
Availability of medical documentation confirming the implementation of the following measures during dynamic observation of a person with BMD by a psychiatric doctor: | ||
7 |
Availability of an individual treatment plan and rehabilitation program for individuals after discharge from an organization providing medical care in the field of mental health, except for those discharged by court order as having recovered early. | ||
8 |
Availability of medical documentation confirming the implementation of primary health care by a physician, if a person with primary health care is suspected or identified, except for primary health care requiring emergency and urgent medical and social care: | ||
9 |
Presence of a record in the medical documentation confirming the implementation of the following measures by a psychiatric doctor of MHO or PMHC upon suspicion or identification of a person with a mental disorder, except for mental disorders requiring emergency and urgent medical and social care: | ||
10 |
Presence of a record in the medical documentation confirming the implementation of measures by a psychiatric doctor of the MHCor RMHC when a person who was previously under dynamic observation with a BMD and removed from the register in the MIS applies, indicating the reason for removal, other than "recovery, persistent improvement": | ||
11 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical reports) on the clinical audit conducted by the Patient Support Service and internal expertise and its assessment according to the following criteria: | ||
Requirements for entities (objects) providing medical and social assistance in the field of mental health in inpatient settings, providing for round-the-clock medical supervision | |||
12 | Availability of documentation confirming the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social medical insurance on a free basis | ||
13 | Availability of a concluded co-insurance agreement for professional liability of medical workers | ||
14 |
Presence of a record in the medical documentation confirming the validity of hospitalization in inpatient clinical departments. | ||
15 |
Presence of a record in the medical documentation confirming compliance with the requirements for the completeness of the measures taken during planned hospitalization in the inpatient clinical departments of the Republican Scientific and Practical Center for Health Protection, the Central Mental Health Center. | ||
16 |
Presence of a record in the medical documentation confirming compliance with the requirements for the completeness of the measures taken during hospitalization in the inpatient clinical department of the Republican Scientific and Practical Center for Health Protection, the Central Mental Health Center for emergency indications. | ||
17 |
Presence of a record in the medical documentation confirming compliance with the requirements for the completeness of the measures taken during planned hospitalization in POSTIS (psychiatric organization of a specialized type with intensive supervision). | ||
18 |
Presence of a record in the medical documentation confirming compliance with the requirements for the completeness of the measures taken after the admission of a person with BMD to the inpatient clinical department. | ||
19 |
Presence of a record in the medical documentation confirming compliance with the requirements for the completeness of the measures taken after the person’s admission to the inpatient clinical department of POSTIS | ||
20 |
Availability of documentation confirming compliance with monitoring regimes. | ||
21 |
Availability of documentation confirming compliance with the criteria for involuntary hospitalization: | ||
22 |
Availability of medical documentation confirming compliance with the discharge conditions. | ||
23 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical reports) on the clinical audit conducted by the Patient Support Service and internal expertise and its assessment according to the following criteria: | ||
Requirements for entities (objects) providing medical and social assistance in the field of mental health in inpatient settings that do not require round-the-clock medical supervision and treatment and provide for medical supervision and treatment during the daytime with the provision of a bed | |||
24 | Availability of documentation confirming the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social medical insurance on a free basis | ||
25 |
Presence of a record in the medical documentation confirming the indications for treatment in inpatient settings for individuals with BMD. | ||
26 |
Presence of a record in the medical documentation confirming the implementation of measures during hospitalization in a day hospital: | ||
27 |
Presence of a record in the medical documentation confirming compliance with the requirements for the duration of treatment and time of stay in the day hospital. | ||
28 |
Presence of a record in the medical documentation confirming compliance with the requirements for discharge from the day hospital. | ||
29 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical reports) on the clinical audit conducted by the Patient Support Service and internal expertise and its assessment according to the following criteria: | ||
Requirements for entities (objects) providing medical and social assistance to persons with mental and behavioral disorders (diseases) in the form of emergency medical and social assistance | |||
30 | Availability of medical documentation confirming the provision of emergency specialized psychiatric care by specialized teams organized as part of an organization providing emergency medical and social care or a mental health center. | ||
31 | Availability of a concluded co-insurance agreement for professional liability of medical workers | ||
Requirements for entities (objects) providing medical and social rehabilitation in the field of mental health | |||
32 | Availability of documentation confirming the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social medical insurance on a free basis | ||
33 | Availability of a concluded co-insurance agreement for the professional liability of medical workers | ||
34 |
Presence of a record in the medical documentation confirming compliance with the requirements for the provision of medical and social rehabilitation in outpatient or inpatient settings. | ||
35 |
Presence of a record in the medical documentation confirming compliance with the requirements for the provision of medical and social rehabilitation in inpatient settings. | ||
36 |
Availability of medical documentation confirming the implementation of activities of a multidisciplinary group. | ||
37 |
Availability of medical documentation confirming compliance with the requirement for the duration of medical and social rehabilitation. | ||
Requirements for entities (objects) providing medical examination to establish the fact of psychoactive substance use and the state of intoxication | |||
38 | Availability of documentation confirming the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social medical insurance on a free basis | ||
39 | Availability of a concluded co-insurance agreement for professional liability of medical workers | ||
40 |
Presence of a record in the medical documentation confirming compliance with the requirements for the identification of a person referred or arriving for a medical examination. | ||
41 |
Presence of a record in the medical documentation confirming compliance with the requirements for conducting examinations of foreign citizens and minor citizens of the Republic of Kazakhstan. Foreign citizens permanently residing and temporarily staying in the territory of the Republic of Kazakhstan, as well as stateless persons who are intoxicated in a public place, at work, or driving a vehicle, shall be subject to medical examination on a general basis. | ||
42 |
Presence of a record in the medical documentation confirming compliance with the requirements for the medical examination of persons delivered in a severe unconscious state. | ||
43 |
Presence of a record in the medical documentation confirming compliance with the requirements for the conditions for conducting laboratory research or rapid testing of biological media. | ||
44 |
Presence of a record in the medical documentation confirming compliance with the requirements for conducting laboratory research or rapid testing of biological media. | ||
45 |
Presence of a record in the medical documentation confirming compliance with the requirements for conducting a quantitative study of exhaled air for alcohol. | ||
46 |
Presence of a record in the medical documentation confirming compliance with the requirements for registration of a refusal of a medical examination | ||
47 |
Presence of a record in the medical documentation confirming compliance with the requirements for establishing the condition of the person being examined. | ||
48 |
Presence of a record in the medical documentation confirming compliance with the requirements for the execution of the medical examination report. | ||
49 |
Presence of a record in the medical documentation confirming compliance with the requirements for a repeat medical examination. | ||
Requirements for entities (objects) providing temporary adaptation and detoxification | |||
50 | Availability of documentation confirming the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social medical insurance on a free basis | ||
51 | Availability of a concluded co-insurance agreement for professional liability of medical workers | ||
52 |
Presence of a record in the medical documentation confirming compliance with the requirements for organizing the activities of the temporary adaptation and detoxification center: | ||
53 | Presence of a confirmation record of the identification of the delivered person by the employees of the internal affairs bodies and notification to the medical personnel of the TADC. The absence of documents certifying the identity of the delivered person shall not serve as grounds for refusing to place him/her in the TADC. | ||
54 |
Presence of a record of the registration of a person admitted with suspected alcohol intoxication in the register of admissions and refusals of hospitalization. | ||
55 |
Availability of medical documentation confirming the results of the medical examination, which are drawn up in the conclusion of the medical examination conducted at the TADC (hereinafter referred to as the Conclusion) in the approved form. | ||
56 |
Availability of medical documentation confirming the registration by medical personnel of personal belongings, documents, money and other valuables in the registration log of documents and personal belongings of patients according to the form before placing the patient in the TADC. | ||
57 | Availability of a card of a person placed in the Central Adaptation and Detoxification Center (hereinafter referred to as the Patient card) If there are medical indications, treatment shall be prescribed. The doctor's prescriptions shall be entered into the patient card. The frequency of medical examinations shall depend on the patient's condition. | ||
58 | Availability in the medical documentation of a patient's discharge summary, filled out by a psychiatrist (narcologist) on a planned basis upon achieving an improvement in the condition that does not require further observation and treatment in the conditions of the TADC, within 24 (twenty-four) hours from the moment of admission. Upon discharge, a corresponding entry shall be made in the patient's card and the register of admissions and refusals of hospitalization. | ||
59 | Availability in the medical documentation of a record confirming the receipt by the patient of his/her documents and personal belongings in accordance with the record in the registration log of documents and personal belongings of patients | ||
Requirements for entities (objects) providing medical examination and gender reassignment for persons with gender identity disorders | |||
60 | Availability of documentation confirming the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social medical insurance on a free basis | ||
61 | Availability of a concluded co-insurance agreement for professional liability of medical workers | ||
62 |
Availability of medical documentation confirming compliance with the requirement for conducting a medical examination of persons with gender identity disorders for gender reassignment: | ||
63 | Availability of a referral from a psychiatrist of the examined person in case of doubts about the mental state for inpatient examination in a medical organization | ||
64 |
Referral of the examined person by a psychiatrist, in the absence of BMDs that are contraindications for gender reassignment, to a clinic at the place of residence for a medical examination | ||
Official(s) ________________________________ ____________
position signature_______________________________________
surname, first name, patronymic (if any)
Head of the subject of control _________________ ____________
position signature________________________________________
surname, first name, patronymic (if any)
| Appendix 11 to the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated November 15, 2018 № ҚР ДСМ-32 and the Minister of National Economy of the Republic of Kazakhstan dated November 15, 2018 № 70 |
Checklist
Footnote. Appendix 11 - as amended by the joint order of the Acting Minister of Healthcare of the Republic of Kazakhstan dated 31.03.2025 № 27 and the Deputy Prime Minister - Minister of National Economy of the Republic of Kazakhstan dated 07.04.2025 № 16 (shall come into effect upon expiry of ten calendar days after the date of its first official publication).
in the field of providing medical services (assistance)
________________________________________________________________________
in accordance with Article 138
_____________________________________________________________________
of the Entrepreneurial Code of the Republic of Kazakhstan
in relation to _ entities (objects) providing laboratory services
______________________________________________________________________
name of a homogeneous group of entities (objects) of control
______________________________________________________________________
State body that has appointed an inspection/preventive control
with a visit to the entity (object) of control
_____________________________________________________________________
_______________________________________________________________________
Act on the appointment of an inspection/preventive control with a visit to the entity
(object) of control ________________________________________________________
________________________________________________________________№, date
Name of the entity (object) of control _________________________________________
_______________________________________________________________________
(Individual identification number), business identification number
of the entity (object) of control ______________________________________________
_______________________________________________________________________
Address of location _______________________________________________________
_______________________________________________________________________
_______________________________________________________________________
№ | List of requirements | Complies with the requirements | Does not comply with the requirements |
1 | 2 | 3 | 4 |
1 | Availability of documentation confirming the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social medical insurance on a free basis | ||
2 | Availability of a concluded co-insurance agreement for professional liability of medical workers | ||
3 | Availability of written voluntary consent of the patient or his/her legal representative for invasive interventions and the implementation of treatment and diagnostic measures | ||
4 | Availability of a biosafety specialist on staff at the laboratory (if the laboratory staff exceeds twenty full-time positions) | ||
5 | Availability of portable analyzers on test strips in primary health care organizations | ||
6 |
Availability at the inpatient level in healthcare organizations as part of the consultative and diagnostic laboratory (hereinafter referred to as the CDL) of an additional unit or a separate express laboratory in the intensive care units to perform emergency and urgent laboratory tests in the shortest possible time from taking a sample to reporting the result (within 15-60 minutes). | ||
7 | Availability of medical documentation confirming quality management of laboratory testing based on the stage-by-stage principle, including pre-analytical (identification errors, errors in recording orders, incorrect sample type, incorrect fill level, samples unsuitable for transportation and storage problems, contaminated samples, hemolyzed samples, samples with clots, errors in testing requests, inappropriate sample collection time, request legibility and/or comprehensibility, inappropriate requests), analytical (tests with unacceptable IQC data, tests not covered by EQA, not compliant with EQA), and post-analytical (comments (interpretation of results, etc.), notification of results) stages of laboratory testing | ||
8 | Presence of a record in the medical documentation confirming compliance with the requirements for the use of equipment certified and registered in the Republic of Kazakhstan, diagnostic reagent kits, test systems and consumable components for performing research | ||
9 | Presence/absence of a laboratory information system | ||
10 | Availability of in-laboratory quality control of the study | ||
11 | Availability of medical documentation confirming compliance with triple packaging and temperature conditions during transportation of biomaterial, including by road, air and rail transport | ||
12 | Availability of medical documentation confirming compliance with the algorithm for conducting analytical quality control in laboratory diagnostics | ||
13 | Availability of a contract for the provision of paid medical services in healthcare organizations. Availability of documents establishing the fact of co-payment | ||
14 | Presence of a record in medical documentation confirming the competence and quality of laboratory diagnostics | ||
15 | Documentation of laboratory diagnostics |
Official(s) ________________________________ ____________
position signature_______________________________________
surname, first name, patronymic (if any)
Head of the subject of control _________________ ____________
position signature________________________________________
surname, first name, patronymic (if any)
| Appendix 12 to the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated November 15, 2018, № ҚР ДСМ-32 and the Minister of National Economy of the Republic of Kazakhstan dated November 15, 2018, № 70 |
Checklist
Footnote. Appendix 12 - as amended by the joint order of the Acting Minister of Healthcare of the Republic of Kazakhstan dated 31.03.2025 № 27 and the Deputy Prime Minister - Minister of National Economy of the Republic of Kazakhstan dated 07.04.2025 № 16 (shall come into effect upon expiry of ten calendar days after the date of its first official publication).
in the field of providing medical services (assistance)
________________________________________________________________________
in accordance with Article 138
_____________________________________________________________________
of the Entrepreneurial Code of the Republic of Kazakhstan in relation to _ entities (objects)
providing emergency medical care and medical care in the form of medical aviation
name of a homogeneous group of entities (objects) of control
______________________________________________________________________
State body that has appointed an inspection/preventive control
with a visit to the entity (object) of control
_____________________________________________________________________
_______________________________________________________________________
Act on the appointment of an inspection/preventive control with a visit to the entity
(object) of control ________________________________________________________
________________________________________________________________№, date
Name of the entity (object) of control _________________________________________
_______________________________________________________________________
(Individual identification number), business identification number
of the entity (object) of control ______________________________________________
_______________________________________________________________________
Address of location _______________________________________________________
_______________________________________________________________________
_______________________________________________________________________
№ | List of requirements | Complies with the requirements | Does not comply with the requirements |
1 | 2 | 3 | 4 |
General requirements | |||
1 | Availability of documentation confirming the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social medical insurance on a free basis | ||
2 | Availability of a concluded co-insurance agreement for professional liability of medical workers | ||
3 | Availability of supporting documentation on the compliance of the treatment and diagnostic measures with the recommendations of clinical protocols | ||
4 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical reports) on the clinical audit conducted by the Patient Support Service and internal expertise and its assessment according to the following criteria: | ||
For emergency medical care | |||
5 | Availability of equipment of medical transport with radio communication and navigation system | ||
6 | Availability in the emergency medical service of regions, cities of republican significance and the capital of an automated control system for receiving and processing calls and systems that allow monitoring of ambulance transport using navigation systems, as well as a system for computer recording of dialogues with subscribers and automatic identification of the telephone number from which the call is received. Storage of dialogue recordings shall be carried out for at least 2 years. | ||
7 | Availability of regional Call-centers as part of regional emergency medical care stations and emergency medical care stations of cities of republican significance and the capital | ||
8 | Presence of a record in the medical documentation on compliance with the requirements for 5-minute processing of an ambulance call from the moment it is received by the dispatcher, during which time the call is sorted according to the urgency category. | ||
9 | Presence of a record in the medical documentation on compliance with the time of arrival of the team to the patient's location from the moment of receiving a call from the dispatcher in accordance with the list of categories of urgency of calls to emergency medical care (from 10 minutes to 60 minutes) | ||
10 |
Presence of a record in the medical documentation on the correct determination by the emergency medical service dispatcher of calls by urgency category in accordance with: | ||
11 |
Presence of a record in the medical documentation on the adoption by a paramedic or doctor of the ambulance team or ambulance department when organizing primary health care of one of the following decisions based on the results of examination data, instrumental diagnostics, dynamics of the patient's condition during or after the treatment measures taken, in accordance with the preliminary diagnosis reflecting the causes of this condition: | ||
12 | Availability of medical recommendations for further contact with a primary health care organization (at the place of residence or attachment) in the event of leaving a patient who does not require hospitalization at the place of call or home, by an ambulance team or an ambulance department at a primary health care organization | ||
13 | Availability of a signal sheet for the patient in case of illness of the patient and the need for a home visit by the local doctor | ||
14 |
Presence of a recording of the following data upon receipt of a call to the dispatch service of the ambulance station: | ||
15 |
Presence of a record in the medical documentation on compliance with the arrival time of paramedic and specialized (medical) teams to the patient's location from the moment of receiving a call from the ambulance station dispatcher, taking into account the urgency category: | ||
16 | Presence of a record of informing the emergency medical service dispatcher of the hospital admission department about the patient's delivery if a decision is made by the emergency medical service team or emergency medical service department when organizing primary health care to transport the patient to the hospital | ||
17 | Availability of a minimum list of medical products for ambulance transport of an ambulance station in classes A, B and C | ||
For medical assistance in the form of medical aviation | |||
18 | Availability of a medical flight assignment according to form № 090/у | ||
19 | Availability of medical documentation confirming that the mobile air ambulance team, when transporting the patient(s), continuously assesses the condition and treats the patient(s) according to the relevant clinical diagnostic and treatment protocols | ||
20 | Availability of grounds for providing medical assistance in the form of medical aviation (an extract from the medical record of a patient in need of medical assistance in the form of medical aviation; an application from the coordinating physician of the medical aviation department to the dispatcher of the Coordinating Organization; in emergency cases, an oral instruction from an authorized body, with written confirmation; a call from the ambulance service and other emergency services) | ||
21 | Availability of approval by the dispatcher of the coordinating organization of the composition of the mobile medical aviation team and the attracted qualified specialist(s) from the medical organizations of the region with the receipt of their informed consent | ||
22 | Availability in the coordinating organization of a schedule of qualified specialists for the provision of medical care in the form of medical aviation, approved by healthcare entities and medical education organizations | ||
23 |
Availability of informed consent of the patient(s) to the provision of medical care in the form of medical aviation during his/her transportation. | ||
Official(s) ________________________________ ____________
position signature_______________________________________
surname, first name, patronymic (if any)
Head of the subject of control _________________ ____________
position signature________________________________________
surname, first name, patronymic (if any)
| Appendix 13 to the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated November 15, 2018, № ҚР ДСМ-32 and the Minister of National Economy of the Republic of Kazakhstan dated November 15, 2018, № 70 |
Checklist
Footnote. Appendix 13 - as amended by the joint order of the Acting Minister of Healthcare of the Republic of Kazakhstan dated 31.03.2025 № 27 and the Deputy Prime Minister - Minister of National Economy of the Republic of Kazakhstan dated 07.04.2025 № 16 (shall come into effect upon expiry of ten calendar days after the date of its first official publication).
in the field of providing medical services (assistance)
________________________________________________________________________
in accordance with Article 138
______________________________________________________________________
of the Entrepreneurial Code of the Republic of Kazakhstan in relation to _ entities (objects)
operating in the field of HIV prevention
name of a homogeneous group of entities (objects) of control
______________________________________________________________________
State body that has appointed an inspection/preventive control
with a visit to the entity (object) of control
______________________________________________________________________
_______________________________________________________________________
Act on the appointment of an inspection/preventive control with a visit to the entity
(object) of control ________________________________________________________
________________________________________________________________№, date
Name of the entity (object) of control _________________________________________
_______________________________________________________________________
(Individual identification number), business identification number
of the entity (object) of control ______________________________________________
_______________________________________________________________________
Address of location _______________________________________________________
_______________________________________________________________________
_______________________________________________________________________
№ | List of requirements | Complies with the requirements | Does not comply with the requirements |
1 | 2 | 3 | 4 |
1 | Availability of documentation confirming the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social medical insurance on a free basis | ||
2 | Availability of a concluded co-insurance agreement for professional liability of medical workers | ||
3 |
Availability of medical documentation confirming that the examination was carried out using the express testing method with registration in the HIV research journal using the express testing method. | ||
4 | Availability of a written notification from a healthcare organization that has revealed during a medical examination the fact of HIV infection in the person being examined about the result obtained, about the need to observe precautionary measures aimed at protecting one's health and the health of others, as well as a warning about administrative and criminal liability for evading treatment and infecting other people with the patient signing a confidential interview sheet with a person infected with HIV in accordance with form № 095/у | ||
5 |
Availability of medical documentation confirming compliance with the deadlines for issuing negative results. | ||
6 |
Availability of medical documentation confirming compliance with the deadlines for sending serum samples to the RSHO. | ||
7 |
Availability of medical documentation confirming compliance with the deadlines for re-examination in case of questionable results. | ||
8 |
Availability of pre-test and post-test counseling. | ||
9 | Availability of medical documentation confirming the referral by a healthcare organization operating in the field of HIV prevention to the territorial government agency in the field of sanitary and epidemiological welfare of an emergency notification in the form № 034/у for each case of HIV infection presumably associated with the provision of medical care (nosocomial) | ||
10 | Availability of a confidential interview sheet with an HIV-infected person, form № 095/у, which shall include consent to enter personal data into electronic information resources. If personal data is refused entry into the ES system, the data entered includes the immune blotting number (hereinafter referred to as IB), IB date, initials, date of birth, epidemiological history data | ||
11 | Availability of medical documentation confirming monitoring and assessment of coverage of key population groups and people living with HIV infection, carried out by maintaining a database of individual client records and relevant forms of accounting documentation by specialists of healthcare organizations operating in the field of HIV prevention | ||
12 | Availability of medical documentation confirming the employer's transfer of medical workers with an established diagnosis of "HIV infection" to other work not associated with a violation of the integrity of the skin or mucous membranes | ||
13 |
Availability of medical documentation confirming the diagnosis and treatment of STIs. | ||
14 | Availability of equipped transport for mobile trust points | ||
15 | Availability of medical documentation confirming the implementation of pre-exposure and post-exposure prophylaxis among the population and key population groups | ||
16 |
Availability of monitoring of contacts within the established timeframes. | ||
17 |
Availability of dynamic monitoring and provision of antiretroviral therapy for HIV-infected individuals. | ||
18 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical reports) on the clinical audit conducted by the Patient Support Service and internal expertise and its assessment according to the following criteria: |
Official(s) ________________________________ ____________
position signature_______________________________________
surname, first name, patronymic (if any)
Head of the subject of control _________________ ____________
position signature________________________________________
surname, first name, patronymic (if any)
| Appendix 14 to the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated November 15, 2018, № ҚР ДСМ-32 and the Minister of National Economy of the Republic of Kazakhstan dated November 15, 2018, № 70 |
Checklist
Footnote. Appendix 14 - as amended by the joint order of the Acting Minister of Healthcare of the Republic of Kazakhstan dated 31.03.2025 № 27 and the Deputy Prime Minister - Minister of National Economy of the Republic of Kazakhstan dated 07.04.2025 № 16 (shall come into effect upon expiry of ten calendar days after the date of its first official publication).
in the field of providing medical services (assistance)
________________________________________________________________________
in accordance with Article 138
______________________________________________________________________
of the Entrepreneurial Code of the Republic of Kazakhstan in relation to _ entities (objects)
operating in the field of blood services
name of a homogeneous group of entities (objects) of control
______________________________________________________________________
State body that has appointed an inspection/preventive control
with a visit to the entity (object) of control
_____________________________________________________________________
_______________________________________________________________________
Act on the appointment of an inspection/preventive control with a visit to the entity
(object) of control ________________________________________________________
________________________________________________________________№, date
Name of the entity (object) of control _________________________________________
_______________________________________________________________________
(Individual identification number), business identification number
of the entity (object) of control ______________________________________________
_______________________________________________________________________
Address of location _______________________________________________________
_______________________________________________________________________
_______________________________________________________________________
№ | List of requirements | Complies with the requirements | Does not comply with the requirements |
1 | 2 | 3 | 4 |
1 | Availability of medical documentation (including electronic document management) (agreement for the provision of medical services and appendices to the agreement, invoices and certificates of completion of work) confirming the fulfillment of contractual obligations for the sale of blood and components, and the provision of medical services within the framework of the guaranteed volume of free medical care and (or) the system of compulsory social medical insurance on a free basis | ||
2 | Availability of a concluded co-insurance agreement for professional liability of medical workers | ||
3 | Availability of conditions for traceability of the movement of blood products from the procurement of raw materials from donors, the production of finished products or the rejection of raw materials to the sale of finished products for medical use or other use ("Info Donor" information system for storing and exchanging medical information about the production of blood products) | ||
4 | Availability of medical documentation confirming compliance with the requirements of laboratory testing of donor blood samples for markers of HIV-1,2, HBV, HCV, syphilis in two stages on automatic closed-type analyzers (equipment register, reagent purchase agreement) | ||
5 | Availability of registration in the electronic information database after the donation of blood and its components of all information about the donation of blood and its components, including the type of reaction and the amount of medical care provided, in the event of side effects of the donation, compliance of documents on the transfer to the primary fractionation unit with the accompanying documentation of the collected blood and its components (form № 126/у "Medical record of the donor of blood and its components", form № 129/у "Form for accounting of the procurement of whole blood and components of donor blood by the apheresis method", form № 131/у "Form for accounting of the production of components of donor blood", form № 153/у "Invoice for the movement of blood products at the stages of production") | ||
6 | Availability of confirmation that the medical examination of blood donors and its components shall be carried out with voluntary informed consent for donation and shall include the following: a confidential interview, an assessment of the results of preliminary and additional laboratory tests, a general examination and a physical examination (form 126/у "Medical record of a blood donor and its components", form № 141/у "Statement of results of primary laboratory tests before donation", donor questionnaire) | ||
7 |
Availability of confirmation of compliance with the requirements for production control of raw materials prepared for the production of blood products: | ||
8 | Availability of written informed consent of the donor for the donation of blood and its components (availability of the document "Form of informed voluntary consent for the donation of blood and its components") | ||
9 | Presence of a record in the medical documentation confirming compliance with the requirements of external quality assessment of laboratory measurements in reference laboratories (report of the proficiency testing provider) | ||
10 | Presence of a record in the medical documentation confirming compliance with the requirements for incoming control of reagents, test systems, the nomenclature of which is approved by the first head of the blood service organization (availability of the order of the head, form № 118y "Incoming control certificate") |
Official(s) ________________________________ ____________
position signature_______________________________________
surname, first name, patronymic (if any)
Head of the subject of control _________________ ____________
position signature________________________________________
surname, first name, patronymic (if any)
Appendix 15
to the joint order of the Minister
of Healthcare of the Republic of Kazakhstan
dated November 15, 2018
№ KR HCM-32 and
the Minister of National Economy
of the Republic of Kazakhstan
dated November 15, 2018 № 70
Criteria for assessing the degree of risk in the sphere of circulation of medicines and medical devices
Chapter 1. General provisions
1. These Criteria for assessing the degree of risks in the sphere of circulation of medicines and medical devices (hereinafter - the Criteria) have been developed in accordance with subparagraph 16) of Article 10 of the Code of the Republic of Kazakhstan “On Public Health and Healthcare System”, paragraphs 5 and 6 of Article 141 and paragraph 1 Article 143 of the Entrepreneurial Code of the Republic of Kazakhstan, the Rules for the formation of risks assessment and management system by regulatory state bodies, approved by order of the acting Minister of National Economy of the Republic of Kazakhstan dated June 22, 2022 № 48 (registered in the Register of state registration of regulatory legal acts under № 28577) and by order of the acting Minister of National Economy of the Republic of Kazakhstan dated July 31, 2018 № 3 “On approval of the checklist’s form” (registered in the Register of state registration of regulatory legal acts under № 17371).
2. The following concepts are used in these Criteria:
1) a point – a quantitative measure of risk calculation;
2) data normalization – a statistical procedure that involves bringing values measured on various scales to a conventionally common scale;
3) risk - the probability of causing harm as a result of the activities of the subject of control of human life or health, the environment, the legitimate interests of individuals and legal entities, the property interests of the state, taking into account the severity of its consequences;
4) risks assessment and management system - the process of making management decisions aimed at reducing the probability of adverse factors occurring by distributing subjects (objects) of control according to risk levels for subsequent implementation of preventive control with a visit to the subject (object) of control and (or) inspections conducted for compliance with qualification or permitting requirements for issued permits, requirements for sent notifications in accordance with the Law of the Republic of Kazakhstan “On Permits and Notifications” (hereinafter - verification of compliance with the requirements) in order to limit the freedom of entrepreneurship to the minimum possible extent, while ensuring an acceptable level of risk in the relevant areas of activity, as well as those aimed at changing the level of risk for a specific subject (object) of control and (or) exemption of such subject (object) of control from preventive control with a visit to the subject (object) of control and (or) inspections for compliance with requirements;
5) objective criteria for assessing the degree of risk (hereinafter - objective criteria) - criteria for assessing the degree of risk used to select subjects (objects) of control depending on the degree of risk in a certain field of activity and not directly dependent on the individual subject (object) of control;
6) criteria for assessing the degree of risk - a set of quantitative and qualitative indicators related to the direct activities of the subject of control, features of industry development and factors influencing this development, allowing the subjects (objects) of control to be assigned to various degrees of risk;
7) subjective criteria for assessing the degree of risk (hereinafter - subjective criteria) - criteria for assessing the degree of risk used for selecting subjects (objects) of control and depending on the results of the activities of a particular subject (object) of control;
8) a checklist - a list of requirements for the activities of subjects (objects) of control, non-compliance with which entails a threat to human life and health, the environment, the legitimate interests of individuals and legal entities, the state;
9) sample set (sample) – a list of assessed subjects (objects) classified as a homogeneous group of subjects (objects) of control in a specific area of state control, in accordance with paragraph 2 of Article 143 of the Entrepreneurial Code of the Republic of Kazakhstan.
Chapter 2. The procedure for forming risks assessment and management system
when conducting preventive control of subjects (objects) of control
3. Risks management when carrying out preventive control with a visit to the subject (object) of control shall be formed by determining objective and subjective criteria, which are carried out in stages (multi-criteria analysis of decisions).
At the first stage, according to objective criteria, subjects (objects) of control are distributed to one of the following degrees of risk:
1) high risk;
2) medium risk;
3) low risk.
According to the indicators of the degree of risk according to subjective criteria, the subject (object) of control refers:
1) to a high degree of risk - with a risk degree indicator from 71 to 100 inclusive;
2) to an average degree of risk - with a risk degree indicator from 31 to 70 inclusive;
3) to a low degree of risk - with a risk degree indicator from 0 to 30 inclusive.
4. Criteria for assessing the degree of risk for conducting preventive control of subjects (objects) of control shall be formed by defining objective and subjective criteria.
Paragraph 1. Objective criteria
5. Determination of risk according to objective criteria shall be carried out depending on the specifics of the area in which state control is carried out, taking into account one of the following criteria:
1) level of danger (complexity) of the object;
2) the scale of severity of possible negative consequences, harm to the regulated area (region);
3) the possibility of an unfavorable incident for human life or health, the legitimate interests of individuals and legal entities, and the state.
6. After analyzing possible risks, subjects (objects) of control shall be distributed into three degrees of risk according to objective criteria (high, medium and low).
7. A high degree of risk includes subjects (objects) of control carrying out activities related to:
1) production of medicines;
2) manufacturing of medicines;
3) wholesale sales of medicines;
4) production of medical devices;
5) manufacturing of medical devices;
8. A medium degree of risk includes subjects (objects) of control:
1) subjects in the field of circulation of medicines and medical devices that carry out retail sales of medicines;
2) healthcare organizations providing outpatient care;
3) healthcare organizations providing inpatient care and (or) inpatient replacing care;
4) healthcare organizations providing emergency medical care and (or) air ambulance services;
5) healthcare organizations engaged in the procurement, preservation, processing, storage, and sale of blood and its components.
9. A low degree of risk includes subjects (objects) of control:
1) subjects in the field of circulation of medicines and medical devices carrying out retail sales of medicines and having a certificate of good pharmacy practice (GPP);
2) subjects (objects) of control carrying out pharmaceutical activities related to the wholesale and retail sale of medical devices.
10. For subjects (objects) of control classified as high and medium degree of risk according to objective criteria, an inspection for compliance with requirements, preventive control with a visit to the subject (object) of control, preventive control without a visit to the subject (object) of control and an unscheduled inspection shall be conducted.
11. For areas of activity of subjects (objects) of control classified as low degree of risk according to objective criteria, an inspection for compliance with the requirements of preventive control without a visit to the subject (object) of control and an unscheduled inspection shall be conducted.
Paragraph 2. Subjective criteria
12. The determination of subjective criteria in the field of circulation of medicines and medical devices shall be carried out using the following stages:
1) formation of a database and collection of information;
2) analysis of information and risks assessment.
13. Formation of a database and collection of information are necessary to identify subjects (objects) of control.
The following sources of information shall be used to assess the degree of risk:
1) the results of previous inspections and preventive control with visits to subjects (objects) of control;
2) the presence of adverse incidents caused by the fault of the subject of control;
3) the presence and number of confirmed complaints and appeals;
4) the results of preventive control without visiting the subject (object) of control (final documents issued based on the results of preventive control without visiting the subject (object) of control);
5) the results of analysis of information provided by state bodies and organizations;
non-compliance, absence and/or presence of a negative conclusion obtained based on the results of quality assessment of medicinal products and medical devices registered in the Republic of Kazakhstan, as well as non-compliance, absence and/or presence of a negative conclusion obtained based on the results of market sampling, including in medical organizations, of medicinal products and medical devices subject to quality control using a risk-based approach.
The following sources of information shall be used to assess the degree of risk when creating a schedule for requirements compliance:
1) the results of previous inspections and preventive control with visits to subjects (objects) of control;
2) the presence of adverse incidents that arose through the fault of the subject of control;
3) the presence and number of confirmed complaints and appeals;
4) results of preventive control without a visit to the subject (object) of control (final documents issued based on the results of preventive control without a visit to the subject (object) of control);
14. Based on available sources of information, data according to subjective criteria, subject to analysis and assessment shall be formed.
Analysis and assessment of subjective criteria allow us to concentrate the conduct of inspection for compliance with requirements and preventive control of the subject (object) of control in relation to the subject (object) of control with the greatest potential risk.
At the same time, the data of subjective criteria previously taken into account and used in relation to a specific subject (object) of control or data for which the statute of limitations has expired in accordance with the legislation of the Republic of Kazakhstan shall not be used in the analysis and assessment.
In relation to subjects of control who have fully eliminated the violations issued based on the results of the previous preventive control with a visit and (or) inspection for compliance with the requirements, their inclusion in the formation of schedules and lists for the next period of state control shall not be allowed.
15. The degree of violations of requirements for subjects (objects) of control in the field of circulation of medicines and medical devices for compliance with qualification requirements shall be determined in accordance with Appendix 1 to these Criteria and the Degree of violation of requirements for subjects (objects) of control in the field of circulation of medicines and medical devices for conducting preventive control of subjects (objects) of control by information sources shall be determined in accordance with Appendix 2 to these Criteria.
16. Based on the priority of the sources of information used and the significance of indicators of the subjective criteria, in accordance with the procedure for calculating the risk degree indicator according to subjective criteria determined in the List of subjective criteria for determining the degree of risk according to subjective criteria in the field of circulation of medicines and medical devices in accordance with Article 138 of the Entrepreneurial Code of the Republic of Kazakhstan in relation to all subjects (objects) in accordance with Appendix 3 to these Criteria, the risk degree indicator shall be calculated according to subjective criteria.
17. Inspection for compliance with requirements and preventive control with a visit to the subject (object) shall be carried out depending on the purpose and types of activity of the objects, in accordance with checklists in the field of circulation of medicines and medical devices according to Appendices 16, 17, 18, 19, 20, 21 and 25 to this joint order.
18. For areas of activity of subjects (objects) of control classified as high-risk, inspections for compliance with requirements shall be determined by criteria, but shall be carried out no more than once a year.
For areas of activity of subjects (objects) of control classified as medium risk, inspections for compliance with requirements shall be determined by criteria, but shall be carried out no more than once every two years.
For areas of activity of subjects (objects) of control classified as low risk, the frequency of inspections for compliance with requirements shall be determined by criteria for assessing the degree of risk, but not more than once every three years.
Chapter 3. The procedure for calculating the degree of risk according to subjective criteria
19. The calculation of the risk degree indicator according to subjective criteria (R) shall be carried out in an automated mode by summing up the risk degree indicator for violations based on the results of previous inspections and preventive control with visits to subjects (objects) of control (SP) and the risk degree indicator according to subjective criteria determined in accordance with paragraph 13 of these Criteria (SC), with subsequent normalization of the values given in the range from 0 to 100 points.
Rinterm = SP + SC, where
Rinterm - an intermediate indicator of the degree of risk according to subjective criteria,
SP – an indicator of the degree of risk for violations,
SC - an indicator of the degree of risk according to subjective criteria determined in accordance with paragraph 13 of these Criteria.
The calculation shall be made for each subject (object) of control of a homogeneous group of subjects (objects) of control of each sphere of state control. In this case, the list of assessed subjects (objects) of control, classified as a homogeneous group of subjects (objects) of control of one sphere of state control shall form a sample set (sample) for subsequent normalization of data.
20. Based on the data obtained from the results of previous inspections and preventive control with visits to subjects (objects) of control, an indicator of the degree of risk for violations shall be formed, assessed in points from 0 to 100.
If one gross violation is detected from any of the sources of information specified in paragraph 16 of these Criteria, the subject of control shall be assigned a risk indicator of 100 points and shall be subject to inspection for requirements compliance or preventive control with a visit to the subject (object) of control.
SРн – показатель незначительных нарушений;
If gross violations are not detected, the risk level indicator for violations shall be calculated by the total indicator for violations of a significant and minor degree.
When determining the indicator of significant violations, a coefficient of 0.7 shall be applied.
This indicator shall be calculated using the following formula:
SРs = (SР2 х 100/SР1) х 0,7, where:
SPs – an indicator of significant violations;
SР1 – required number of significant violations;
SР2 – number of significant violations identified;
When determining the indicator of minor violations, a coefficient of 0.3 shall be applied.
This indicator shall be calculated using the following formula:
SРm = (SР2 х 100/SР1) х 0,3, where:
SРm – an indicator of minor violations;
SР1 – required number of minor violations;
SР2 – number of minor violations identified;
The violation risk indicator (SP) shall be calculated on a scale from 0 to 100 points and shall be determined by summing the indicators of significant and minor violations according to the following formula:
SР = SРs + SРm, where:
SP – an indicator of the risk degree for violations;
SPs – an indicator of significant violations;
SРm - an indicator of minor violations.
The resulting value of the risk degree indicator for violations shall be included in the calculation of the risk degree indicator based on subjective criteria.
21. The calculation of the risk degree indicator according to subjective criteria determined in accordance with paragraph 16 of these Criteria shall be made on a scale from 0 to 100 points and shall be carried out using the following formula:
xi – an indicator of subjective criterion,
wi – specific weight of the subjective criterion indicator xi,
n – number of indicators.
The resulting value of the risk degree indicator according to subjective criteria, determined in accordance with paragraph 13 of these Criteria, shall be included in the calculation of the risk degree indicator according to subjective criteria.
22. The R indicator values calculated for subjects (objects) shall be normalized to a range from 0 to 100 points. Data normalization shall be carried out for each sample set (sample) using the following formula:
R – risk degree indicator (final) according to the subjective criteria of an individual subject (object) of control,
Rmax – the maximum possible value on the risk degree scale according to subjective criteria for subjects (objects) included in one sample set (sample) (upper limit of the scale),
Rmin – the minimum possible value on the risk degree scale according to subjective criteria for subjects (objects) included in one sample set (sample) (lower limit of the scale),
Rinterm - an intermediate indicator of the degree of risk according to subjective criteria, calculated in accordance with paragraph 16 of these Criteria.
Appendix 1
to the criteria for assessing
the degree of risk in the area
of circulation of medicines
and medical devices
The degree of violation of requirements for subjects (objects) of control in the sphere
of circulation of medicines and medical devices for compliance with qualification requirements
№ | Requirements | Degree of violations |
1. | Compliance of a premise or building under the right of ownership or lease or trust management of state property with sanitary rules establishing sanitary and epidemiological requirements for facilities in the field of circulation of medicines and medical devices | gross |
2. | Availability of equipment and furniture, inventory, instruments and apparatus to ensure quality control and compliance with the conditions of production, manufacturing, storage and sale of medicines and medical devices | gross |
3. | Availability of a motor vehicle with appropriate cabinets, refrigeration, and other equipment, if necessary, ensuring compliance with the conditions of storage and sale of medicines and medical devices for a mobile pharmacy for rural settlements | gross |
4. | Availability of a staff of employees with appropriate education, work experience, and specialist certificates for organizations on the production of medicines and medical devices: higher pharmaceutical or chemical-technological, chemical education and work experience in the specialty for at least three years for heads of departments directly involved in the production of medicines and medical devices, or technical for heads of departments directly involved in the production of medical devices; higher pharmaceutical or chemical, biological education for workers carrying out quality control of medicines and medical devices, or technical education for workers carrying out quality control of medical devices; technical education for a specialist in the maintenance of equipment used in the technological process of production of medicines and medical devices | gross |
5. | Availability of a staff of employees with appropriate education, work experience and a specialist certificate for organizations in the field of circulation of medicines and medical devices that manufacture medicines: higher pharmaceutical education and at least three years of work experience in the specialty for the head of a pharmacy engaged in the manufacture of medicines and its production departments, as well as for the employees who carry out quality control of medicines and medical devices; higher or secondary pharmaceutical education for employees involved in the direct manufacture of medicines and the release of manufactured medicines; secondary pharmaceutical education and at least three years of work experience in the specialty for the head of a pharmacy and its production departments in the absence of specialists with higher pharmaceutical education in the regional center and rural settlements | gross |
6. | Availability of a staff of employees with appropriate education, work experience and a specialist certificate for pharmacies: higher or secondary pharmaceutical education (work experience in the specialty for at least three years) for the head of a pharmacy or its departments; higher or secondary pharmaceutical education for the specialists selling medicines and medical devices; when selling medicines via the Internet, the availability of transport on the right of ownership or lease for delivery in a manner that does not allow changes in their properties during storage and transportation | gross |
7. | Availability of a staff of employees with appropriate education, work experience, and a specialist certificate for a pharmacy in healthcare organizations providing primary health care, consultative and diagnostic care: higher or secondary pharmaceutical education (work experience in the specialty for at least three years) for the head of a pharmacy, as well as for the employees involved in the sale of medicines and medical devices. In pharmacies for rural settlements where there are no pharmacies, in the absence of specialists with pharmaceutical education, specialists with medical education who have been trained to sell them shall be allowed to sell medicines and medical products | gross |
8. | Availability of a staff of employees with appropriate education, work experience and a specialist certificate for a pharmacy warehouse: higher pharmaceutical education and at least three years of work experience for the head of a pharmacy warehouse; higher or secondary pharmaceutical education for the heads of pharmacy warehouse departments and workers involved in the acceptance, storage and release of medicines and medical devices | gross |
9. | Availability of a staff of employees with appropriate education, work experience, and a specialist certificate for a mobile pharmacy for rural settlements: higher or secondary pharmaceutical education for the head of a mobile pharmacy, as well as for the employees involved in the sale of medicines and medical products. In the absence of specialists with pharmaceutical education, specialists with a medical education who have been trained for their sale shall be allowed to carry out retail sales of medicines and medical devices | gross |
10. | Availability of a staff of employees with appropriate education, work experience and a specialist certificate for the manufacture of medical devices and higher or secondary pharmaceutical, medical or technical education | gross |
11. | Availability of specialization or improvement and other types of advanced training over the last 5 (five) years in the declared subtypes of pharmaceutical activities | gross |
12. | Availability of higher or secondary pharmaceutical education (work experience in the specialty - at least three years) for individuals applying to engage in pharmaceutical activities without forming a legal entity | gross |
Appendix 2
to the criteria for assessing
the degree of risk in the area
of circulation of medicines and
medical devices
The degree of violation of requirements for subjects (objects) of control in the sphere of circulation
of medicines and medical devices for conducting preventive control of subjects (objects)
of control by information sources
№ | Name of criteria | Degree of violation |
Section 1. In relation to medical organizations on the issues of drug provision | ||
1. | Compliance with the prescription of medicines containing narcotic drugs, psychotropic substances and their precursors during outpatient and inpatient treatment in health care organizations by a doctor of a health care organization who has access to work with narcotic drugs and their precursors | gross |
2. | Compliance with the recording in the patient’s medical documents of the prescription of medicines containing narcotic drugs, psychotropic substances and precursors of Tables II, III, IV of the List of narcotic drugs, psychotropic substances and precursors subject to control in the Republic of Kazakhstan (hereinafter - the List), indicating a single dose, method and frequency of administration (injection), duration of treatment, as well as justification for prescribing medicines | gross |
3. | Ensuring the use (taking) of medicines containing narcotic drugs, psychotropic substances of Tables II, III of the List strictly under the supervision of medical personnel at the time of their issuance: 1) oral administration, application of transdermal therapeutic systems (plaster, film); 2) in the presence of a nurse, injections - in the presence of a doctor | significant |
4. | Compliance with the rules and procedures for writing prescriptions for medicines containing narcotic drugs, psychotropic substances and precursors | significant |
5. | Availability of a person responsible for storing and issuing special prescription forms | significant |
6. | Ensuring subject-quantitative accounting of special prescription forms | gross |
7. | Availability of a safe or metal cabinet for storing special prescription forms. Upon completion of work, the room shall be sealed and (or) stamped. The keys to the room, the seal and (or) the stamp shall be kept by the responsible person | gross |
8. | Ensuring the storage and destruction of unused special prescriptions given by relatives of deceased patients. Recipes are destroyed as prescriptions accumulate, but at least 1 (one) time per month, by burning in the presence of a permanent commission, which includes a representative of the internal affairs body. The fact of destruction of unused special recipes is in a corresponding act The destruction of prescriptions shall be carried out as recipes accumulate, but at least 1 (one) time per month, by burning in the presence of a permanent commission, which includes a representative of the internal affairs body. The fact of destruction of unused special prescriptions shall be documented by an appropriate act | significant |
9. | Availability of a list of medicines containing narcotic drugs, psychotropic substances of Table II of the List, determined by order of the head of the healthcare organization, not exceeding a five-day supply, which is used with the permission of the responsible doctor on duty to provide emergency medical care in a healthcare organization providing inpatient care in the evening and at night | gross |
10. | Ensuring the collection and destruction of empty ampoules of medicines containing narcotic drugs, psychotropic substances of Table II of the List, the contents of which are not used or partially used, as well as tablets and patches (transdermal therapeutic systems) | gross |
11. | Availability of an order for a medical worker responsible for issuing a temporary death certificate, ensuring notification of relatives of a deceased cancer patient about the delivery of unused special prescription forms and medicines containing narcotic and psychotropic substances of Table II of List, as well as the acceptance of special prescription forms and unused medicines, containing narcotic and psychotropic substances of Table II of the List after patients died at home. Availability of acts of acceptance and transfer of medicines containing narcotic drugs, psychotropic substances and their precursors remaining after the death of the patient | gross |
12. | The presence of a permanent commission, which includes representatives of internal affairs bodies and the territorial division of the state body in the field of sanitary and epidemiological welfare of the population for the destruction of medicines containing narcotic drugs, psychotropic substances of Table II List with expired expiration dates, handed over by relatives of deceased patients, and also broken, defective, empty ampoules, tablets and patches (transdermal therapeutic systems), as well as ampoules, tablets and patches (transdermal therapeutic systems), the contents of which have been partially used | significant |
13. | Availability of acts of destruction of medicines containing narcotic drugs, psychotropic substances and their precursors of Tables II, III, IV of List | significant |
14. | Compliance with the rules and procedures for registration and storage of medical documentation, requirements for medicines containing narcotic drugs, psychotropic substances and precursors of Tables II, III, IV of the List | significant |
15. | Compliance with prescription regulations | significant |
16. | Ensuring accounting and monitoring of prescriptions for free or preferential receipt of medicines | significant |
17. | Ensuring that sample signatures of authorized persons entitled to sign prescriptions are sent to the facilities of the pharmaceutical organization | minor |
18. | Reflection in the patient's outpatient card of the contents and numbers of prescriptions for free or preferential receipt of medicines | significant |
19. | Ensuring the calculation of the need for medicines: 1) in accordance with the medicinal formulary of the medical organization; 2) based on data on the dynamics of morbidity and the epidemiological situation in the region, as well as statistical data on the projected number of patients; 3) taking into account registers of treated patients; 4) taking into account the actual consumption of medicines for the previous year and the projected balance as of January 1 of the next financial year | significant |
20. | Compliance with the conditions for the purchase of medicines and pharmaceutical services within the framework of the guaranteed volume of free medical care (hereinafter - GVFMC) and medical care in the system of compulsory social health insurance (hereinafter - CSHI) | significant |
21. | Ensuring the distribution of medicines depending on the projected number of patients and certain categories of citizens living in populated areas, by types of diseases | significant |
22. | Availability in medical organizations providing outpatient care, facilities in the field of circulation of medicines, providing pharmaceutical services within the framework of the guaranteed volume of free medical care, as well as in periodicals distributed in the territory of the relevant administrative-territorial unit, the following information for patients is posted: 1) list and addresses of facilities in the field of circulation of medicines that provide pharmaceutical services within the framework of the guaranteed volume of medical care; 2) addresses of organizations providing outpatient care through which outpatient drug provision is provided; 3) address and telephone number of the customer for the provision of pharmaceutical services | M inor |
23. | Compliance with the rational use (prescription) of medicines and the formation of a medicine formulary based on proven clinical effectiveness and safety of medicines | significant |
24. | The presence of a permanent commission that, at least once a quarter, shall conduct analysis of medical prescriptions at the inpatient, inpatient replacing and outpatient levels | minor |
25. | Ensuring the accounting of medicines within the framework of the guaranteed volume of medical care during the provision of inpatient, inpatient-replacing and outpatient care within the framework of the guaranteed volume of free medical care in total and quantitative terms in medical records or automated programs for recording and use of medicines | gross |
26. | Reflection of used medicines in the medical card of an inpatient patient, in the list of medical prescriptions | significant |
27. | Ensuring that medicines received for the provision of emergency, inpatient and inpatient-replacing care within the framework of the GVFMC shall be marked with the stamp of a medical organization indicating the name of the medical organization, its address and the mark “Free” | minor |
28. | Entering information about side effects, serious side effects and lack of effectiveness in the medical card of an inpatient and (or) outpatient patient, and including maintenance of statistics on identified cases of side effects in a medical organization | significant |
29. | Compliance with the requirements for separate storage and accounting of medicines and medical devices purchased for the provision of medical care within the framework of the FVFMC, additional volume of medical care for persons held in pre-trial detention centers and institutions of the penal (penitentiary) system, at the expense of budgetary funds and (or) in the system of CSHI and paid services | gross |
30. | Compliance with maximum prices for the trade name of medicines and medical devices, for the international nonproprietary name of a medicine or the technical characteristics of a medical device within the framework of the GVFMC and (or) in the system of CSHI | gross |
31. | In medical organizations providing medical care at all levels within the framework of the SVFMC, an additional volume of medical care for persons held in pre-trial detention centers and institutions of the penal (penitentiary) system, at the expense of budgetary funds and (or) in the system of CSHI, a stock of medicines and medical devices shall be created: for at least one month, with the exception of providing medical care for HIV infection, where a supply of medicines and medical devices shall be created for at least three months | gross |
32. | The provision of medicines, medical devices, specialized medicinal products, immunobiological medicines within the framework of the GVFMC and (or) in the system of CSHI when providing primary health care and specialized medical care in an outpatient condition shall be carried out in accordance with the list of medicines and medical devices for free and (or) preferential outpatient provision for certain categories of citizens of the Republic of Kazakhstan | gross |
33. | The provision of medicines and medical devices on an outpatient basis within the framework of the GVFMC and (or) in the system of CSHI for citizens, fellow countrymen, refugees, foreigners and stateless persons permanently residing in the territory of the Republic of Kazakhstan and serving sentences by court in places of deprivation of liberty, detainees, prisoners in custody and placed in special institutions, registered at the dispensary, shall be carried out at the place of attachment to medical organizations | gross |
34. | Providing certain categories of citizens with certain diseases (conditions) with free and (or) preferential medicines and medical devices on an outpatient basis within the framework of the GFVMC and (or) in the system of CSHI free of charge with a doctor’s prescription | gross |
35. | The issuance of first aid kits for mother and child to newborns shall be carried out upon discharge from obstetric organizations with a note of issue in the development history of a newborn | gross |
36. | Compliance with the procedure for generating the need for medicines and medical devices within the framework of the SVFMC and the system of CSHI: 1) compiling a calculation of the need for medicines and medical devices within the framework of the SVFMC, additional volume of medical care for persons held in pre-trial detention centers and institutions of the penal (penitentiary) system, at the expense of budgetary funds and (or) in the system of CSHI: taking into account the established daily dose for medicines; based on data on actual consumption of medicines and medical devices for the previous financial year; 2) organizing and conducting the purchase of medicines, medical devices and specialized medical products, pharmaceutical services within the framework of the GVFMC, additional volume of medical care for persons held in pre-trial detention centers and institutions of the penal (penitentiary) system, at the expense of budgetary funds and (or) in the system of CSHI on the issues of drug provision and compliance with price limits; 3) organization and procurement of services for the storage and transportation of medicines and medical devices, services for accounting and sale of medicines and medical devices by a single distributor within the framework of the SVFMC, additional volume of medical care for persons held in pre-trial detention centers and penal (penitentiary) institutions) systems, at the expense of budgetary funds and (or) in the system of CSHI on the issues of drug provision; 4) provision of medicines and medical products within the framework of the GVFMC, additional volume of medical care to persons held in pre-trial detention centers and institutions of the penal (penitentiary) system, at the expense of budgetary funds and (or) in the system CSHI; 5) provision of medicines and medical devices in rural areas where there are no pharmacies; 6) ensuring the rational use of medicines and conducting assessments of the rational use of medicines; 7) storage, accounting of medicines and medical devices, when providing medical care within the framework of the GVFMC, additional volume of medical care to persons held in pre-trial detention centers and institutions of the penal (penitentiary) system, at the expense of budgetary funds and (or) in the system of CSHI | gross |
37. | Ensuring the availability in medical organizations providing medical care at all levels within the framework of GVFMC, an additional volume of medical care for persons held in pre-trial detention centers and institutions of the penal (penitentiary) system, at the expense of budgetary funds and (or) in the compulsory medical insurance system, of a supply of medicines and medical devices: for at least one month, with the exception of providing medical care for HIV infection, where a supply of medicines and medical devices shall be created for at least three months | gross |
38. | Ensuring the redistribution of medicines and medical devices between medical organizations independently in cases of changes in the dynamics of morbidity, transfer or relocation of a patient, changes in the treatment regimen due to intolerance, drug resistance, death, liquidation of medical organizations, changes in the profile of medical services at all levels of medical care | significant |
39. | Compliance with the calculation of the projected need in medicines for the provision of medical care in inpatient and inpatient-replacing conditions | significant |
40. | Compliance with the ethical conditions for promoting medicines and medical devices in terms of: To participate in daily medical conferences in medical organizations and educational organizations in the field of healthcare, representatives of manufacturers and (or) distributors ten calendar days before planned participation in the daily medical conference they agree in writing on the time and topic of the event with the head of the healthcare organization. Individual contacts of manufacturers, distributors, or authorized representatives, as well as other entities in the field of circulation of medicines and medical devices authorized to promote medicines and medical devices, with medical and pharmaceutical workers during their working hours and at the workplace for the purpose of promoting medicines and medical devices shall be excluded. In the interaction of entities in the field of circulation of medicines and medical devices with members of professional associations, it is excluded that members of professional associations may encourage the adoption of any decisions in the process of carrying out its statutory activities in favor of entities in the field of circulation of medicines and medical devices. Members of professional associations do not allow the facts of financial and other conspiracies in order to obtain benefits when promoting certain medicines and medical devices to the market, but at the same time make efforts to suppress such actions | gross |
41. | Preventing ethical violations of the promotion of medicines and medical devices in the interaction of entities in the field of circulation of medicines and medical devices: 1) providing or offering financial remuneration or any other incentives of a material or non-material nature to medical and pharmaceutical workers for prescribing and releasing certain medicines; 2) payment for entertainment, recreation, travel to a place of recreation, with the exception of payments related to the implementation of scientific and educational activities; 3) concluding agreements, organizing promotions for prescribing or recommending medicines and medical devices to patients with the involvement of medical workers, with the aim of obtaining material benefits, with the exception of written official agreements on conducting biomedical, clinical-economic, epidemiological, and other types of researches not prohibited by the legislation of the Republic Kazakhstan, as well as agreements on participation in ongoing marketing researches; 4) providing samples of medicines and medical devices to patients, except for cases not prohibited by the legislation of the Republic of Kazakhstan; 5) encouragement to prescribe medicines and medical devices on prescription forms of an unspecified form, including those containing advertising information, as well as with pre-printed names of medicines and medical devices; 6) organization of programs in accordance with which property and non-property prizes are provided, gifts to heads of pharmacy organizations and pharmaceutical workers for achieving certain sales results | gross |
42. | Placement in places of visual information for patients and on the Internet resource of a medical organization of a list of medicines and medical products for free and (or) preferential outpatient care for certain categories of citizens of the Republic of Kazakhstan with certain diseases (conditions), as well as the addresses of medical organizations through which outpatient care is provided and the number of a toll-free telephone line (if available) to obtain information on the use of medicines | minor |
43. | Compliance with a two-year storage period for prescriptions for medicines released within the framework of SVFMC and (or) CSHI | minor |
44. | Availability of a health specialist certificate for each pharmaceutical worker | gross |
45. | Availability of a state license for pharmaceutical activities and appendices for subtypes of activity or notification on the start of activity. Compliance with the types and subtypes of activities declared upon receipt of the state license and its appendices | gross |
46. | Ensuring storage and transportation in accordance with the conditions established by the manufacturer in the regulatory and technical document on monitoring the quality and safety of medicines, in the instructions for medical use for medicines and medical devices, operational documents (for medical devices), indicated in the labeling of their packages | gross |
47. | Ensuring the safety, storage conditions of various groups of medicines and medical devices and their handling by complying with the requirements for the design, arrangement, composition, size of areas, equipment of premises (areas) for storing medicines and medical devices and their operation, ensuring safety | gross |
48. | Compliance with separate storage of medicines and medical devices from other products in order to avoid any impact on them, protection from the negative effects of light, temperature, moisture and other external factors | gross |
49. | Keeping records of the expiration dates of medicines and medical devices on paper or electronic media | minor |
50. | Carrying out the storage of medicines and medical devices in designated and clearly marked storage areas | significant |
51. | Providing the storage room, including the refrigeration room (chamber), with appropriate equipment for monitoring temperature, air humidity (thermometers, hygrometers, other types of instruments), and their location on the internal walls of the premises away from heating devices based on the results of testing zones of temperature fluctuations for cold and warm season | gross |
52. | Compliance with separation during storage of all medicines and medical devices depending on the pharmacological group, method of administration, physical state, physicochemical properties, exposure to various environmental factors | gross |
53. | Availability of an isolated place for storing medicines, the decision on the circulation of which has not yet been made, expired, returned, withdrawn from the category suitable for supply, for which there are suspicions of falsification, recalled and rejected | gross |
54. | Ensuring protection from the effects of weather conditions in the areas of acceptance and shipment. Availability of equipment in the areas of acceptance and shipment (ventilation/ air conditioning system, hygrometer, thermometer), equipment for cleaning containers. Availability of an equipped control area for the received products | gross |
55. | Separation of zones for acceptance, quarantine, defects, shipment and storage, as well as the availability of a room in which medicines are stored in quarantine, with clear markings and limited access | gross |
56. | Availability of common fireproof buildings with insulation by fireproof walls from neighboring premises that meet fire safety requirements in the absence of separate storage facilities for flammable substances, providing the premises with supply and exhaust ventilation | gross |
57. | Storage of flammable medicines separately from other medicines: provision of fireproof and stable racks and pallets, storage of flammable and combustible liquids in built-in fireproof cabinets with doors at least 0.7 meters wide and at least 1.2 meters high | gross |
58. | Storage of flammable liquids isolated in separate rooms in glass or metal containers from other groups | gross |
59. | Compliance with the storage of flammable and combustible liquid medicines that should not be stored: 1) in a completely filled container, the degree of filling is not more than 90 percent of the volume. Alcohols in large quantities are stored in metal containers, which are filled to no more than 95 percent of the volume; 2) with mineral acids (sulfuric, nitric and other acids), compressed and liquefied gases, flammable substances, as well as with inorganic salts that produce explosive mixtures with organic substances (potassium chlorate, potassium permanganate) | gross |
60. | Compliance with isolated storage of calcium hypochloride, taking into account its properties | gross |
61. | Compliance with the storage of flammable liquids with constant monitoring of the containers condition, their tightness and serviceability | gross |
62. | Implementation of measures during storage of explosive drugs against contamination by dust. | gross |
63. | Compliance with separate storage of explosive and flammable medicines containing acids and alkalis. | gross |
64. | Ensuring the protection of cylinders with oxygen and flammable gases from heat sources, contact with oil and other fatty substances, and their storage in isolated rooms or under canopies | gross |
65. | Compliance with the conditions for storing dressings in a dry, ventilated area in cabinets, drawers, on racks, shelves, pallets, in conditions that ensure cleanliness | gross |
66. | Compliance with the storage conditions of medical instruments, devices, instruments, equipment in dry heated rooms at room temperature, with a relative air humidity not exceeding 65 percent | gross |
67. | Compliance with the requirements for finishing premises (areas) for storing medicines and ensuring the cleanliness of premises and storage equipment | significant |
68. | Ensuring protection from insects, rodents or other animals and availability of a preventive pest control program | minor |
69. | Separation of rest rooms, dressing rooms, showers and toilets for workers from storage rooms (areas). Food products, drinks, tobacco products, and medicines for personal use shall not be stored in storage rooms (areas). Availability of protective clothing or uniform appropriate for the work performed and personal protective equipment if necessary for employees working in the storage area. Personnel working with dangerous drugs shall undergo special training | significant |
70. | Providing with the necessary equipment and inventory on the premises for the medicines storage: 1) racks, pallets, shelves, cabinets for storing medicines and medical devices; 2) technological equipment for creating temperature conditions; 3) devices for recording temperature and humidity; 4) means of mechanization for loading and unloading operations; 5) disinfectants and cleaning equipment to ensure sanitary conditions; 6) other equipment and inventory ensuring sanitary and hygienic conditions, labor protection, safety precautions, fire safety, environmental protection, and safety of medicines | gross |
71. | Availability of a document on calibration (verification) of equipment used to control and monitor storage conditions | gross |
72. | Availability of a developed and approved emergency action plan in case of malfunction of the refrigeration room (chamber), refrigeration equipment or power outage, emergency situations | significant |
73. | Availability of developed and approved instructions for cleaning and disinfection of equipment. The equipment is used in good condition and kept in proper cleanliness | significant |
74. | Availability of a person responsible for ensuring the safety of the quality of medicines and medical devices at facilities storing medicines and medical devices | significant |
75. | Presence of a commission for the destruction of medicines and medical devices unsuitable for sale and medical use | significant |
76. | Availability of acts on the destruction of medicines and medical devices unsuitable for sale and medical use | significant |
77. | Availability of secondary package labeling, including the following information: 1) trade name of the medicine; 2) international nonproprietary name (if available) in Kazakh, Russian and English; 3) name of the manufacturer of the medicine, address. The name of the manufacturer and its address shall be indicated in full or abbreviated (city, country). A trademark shall be indicated when it is granted legal protection in the Republic of Kazakhstan. If the manufacturer of the medicinal product is not its packager, then the name of the packager, date and time of packaging shall be indicated; 4) name of the holder of the registration certificate, his address (city, country); 5) dosage form; 6) dosage, and (or) activity, and (or) concentration (if applicable) of the active pharmaceutical substance (active pharmaceutical substances); 7) the amount of the medicine in the package by weight, volume or number of dosage units, depending on the dosage form and type of packaging; 8) information on the composition of the medicine; 9) for medicinal herbal preparations, which are packaged medicinal plant raw materials, the mass of medicinal plant raw materials and (or) active pharmaceutical substance of plant origin shall be indicated at their certain humidity; 10) for medicinal products containing narcotic substances, psychotropic substances, their analogs, and precursors, the names of these substances and their content in weight units or percentages shall be indicated. In single-component medicinal products, subject to the authenticity of the medicine name and the active pharmaceutical substance and indication of its dosage, concentration, activity, the composition of the active pharmaceutical substance shall not be indicated; 11) list of excipients: 12) for infusion solutions that contain more than one active pharmaceutical substance, the value of osmolarity and (or) osmolality shall be indicated; 13) method of administration and, depending on the dosage form, route of injection (the method of administration shall not be indicated for tablets and capsules intended for oral administration); 14) precautions; 15) warning notices; 16) storage conditions, storage features and transportation conditions; 17) conditions of release (with a prescription or without a doctor’s prescription); 18) series number; 19) production date (if not entered in the batch number); 20) expiration date: “best before: (date, month, year)” or “(date, month, year)”; The expiration date is indicated as “best before (month, year)” or “(month, year)”, while the expiration date is determined up to and including the last day of the specified month; 21) registration number of the medicinal product in the form of the designation “RK-MP-”; 22) barcode (if available); 23) means of identification or a material medium containing means of identification | gross |
78. | Availability of labeling of primary package indicating the following information: 1) trade name of the medicine, indicating the dosage, activity or concentration; 2) international nonproprietary name (if available) in the state, Russian and English languages; 3) the name of the manufacturer of the medicinal product and (or) its trademark; 4) series number; 5) expiration date “month, year” or “date, month, year” Additional information is placed that is identical to the information printed on the secondary packaging. Intermediate packaging, which does not allow the information on the primary packaging to be read without compromising its integrity, repeats the information indicated on the primary packaging. | gross |
79. | Organization of work to monitor adverse reactions and (or) lack of effectiveness of medicines and medical devices, appointment of responsible persons for monitoring side effects of medicines and medical devices | significant |
80. | Provision by the responsible person to the authorized organization of information about side effects and (or) lack of effectiveness of medicines and medical devices. Transmission of report cards through the portal of an authorized organization online containing a mandatory minimum amount of information | significant |
81. | Compliance with the deadlines for submitting a completed report card about adverse reactions (actions) and (or) effectiveness to the authorized organization in cases of detection | significant |
82. | Absence of facts of purchase, production, storage, advertising, use, provision and sale of medicines and medical devices that have not passed state registration in the Republic of Kazakhstan | gross |
83. | Absence of facts of production, import, storage, use and sale of counterfeit medicines and medical devices | gross |
84. | Absence of facts of sales of medicines and medical devices, the quality of which is not confirmed by a conclusion on safety and quality | gross |
85. | Absence of facts of storage, use and sale of expired medicines and medical devices | gross |
86. | Compliance of the medicine with the requirements of the regulatory document on control of the quality and safety of the medicine and medical device (based on the results of assessing the safety and quality of samples withdrawn as doubt) | gross |
87. | Compliance with the requirements for storage, accounting, destruction of medicines containing narcotic drugs, psychotropic substances and precursors (including substances): The destruction of narcotic drugs, psychotropic substances, their analogues and precursors can be carried out in cases when: 1) the shelf life of the narcotic drug, psychotropic substance and precursors has expired; 2) narcotic drugs, psychotropic substances, precursors have been subjected to chemical or physical influence, resulting in their unusability, excluding the possibility of their restoration or processing; 3) confiscated, discovered and seized from illegal traffic of narcotic drugs, psychotropic substances, their analogs and precursors do not represent medical, scientific or other value and cannot be processed, as well as in other cases provided for by the legislation of the Republic of Kazakhstan. | gross |
88. | Availability of a list of persons who have conclusions from psychiatrists and narcologists about the absence of drug addiction, substance abuse, chronic alcoholism, as well as about suitability for carrying out activities related to narcotic drugs, psychotropic substances and their precursors and the conclusion of the internal affairs bodies to conduct the relevant check | gross |
89. | Storage rooms, safes and cabinets shall be kept closed. After the end of the working day, they shall be stamped and (or) sealed. Keys, stamp and (or) seal shall be kept by the responsible person | gross |
90. | Availability of a first aid kit | minor |
91. | Availability of a sign indicating the name of the subject of pharmaceutical activity, its organizational and legal form and mode of operation in the state and Russian languages | minor |
92. | Availability of information about the telephone numbers and addresses of territorial subdivisions of the state body in the field of circulation of medicines and medical devices in a place convenient for the public to familiarize | minor |
93. | Ensuring the traceability of medicines marked with identification means by providing with information on the introduction into circulation, on the sale and (or) transfer, as well as on the withdrawal from circulation of labeled medicines in the territory of the Republic of Kazakhstan by the participants in the circulation of medicines and subjects in the field of circulation of medicines and medical devices | gross |
94. | Compliance with the rules for advertising medicines and medical devices: 1) advertising of medicines and medical devices is reliable, recognizable without special knowledge or the use of special means, to exclude comparisons with other pharmaceutical services, medicines and medical devices, not to mislead the consumers by abusing their trust, including with regard to characteristics, composition, consumer properties, cost (price), expected results of use, results of research and testing; 2) advertising of medicines and medical devices is provided in the Kazakh and Russian languages, contains complete and reliable information about the medicine or medical device, complies with the instructions for medical use of the medicine (insert leaflet), instructions for medical use or operational document for the medical device; 3) availability of a conclusion on the compliance of advertising of medicines and medical devices with the requirements of the legislation of the Republic of Kazakhstan in the field of healthcare | gross |
95. | Prohibition of advertising of medicines and medical devices: 1) not registered in the Republic of Kazakhstan; 2) prescription drugs in the media; 3) distribution for advertising purposes of samples of medicines released with a doctor’s prescription; 4) the use of children, their images and voices in advertising of medicines and medical devices, except for medicines and medical devices for children; 5) distribution and placement of advertising of medicines and medical devices in public transport, organizations not related to their purpose, use and release, with the exception of advertising of medicines at medical, pharmaceutical conferences, congresses, symposiums and other scientific meetings; 6) placement of advertising information on industrial products, prescription forms; 7) placement of outdoor (visual) advertising of medicines and medical devices; 8) the use of medical workers authorized to prescribe medicines and medical devices as distributors of advertising, with the exception of cases of providing reliable information about medicines and medical devices for scientific or educational purposes, as well as for the purpose of informing patients; 9) advertising of pharmaceutical services in the absence of a license to carry out the relevant type of activity; 10) advertising of pharmaceutical services provided by persons who do not have a certificate as a specialist in the field of healthcare, including foreign specialists; 11) indication in advertising for the population of treatment methods for the following diseases: sexually transmitted diseases, cancer, mental, behavioral disorders (diseases), dangerous infectious diseases, HIV infection, tuberculosis, diabetes mellitus; 12) refer in advertising to the recommendations of scientists, healthcare professionals, as well as government officials who may encourage the use and (or) prescription of medicines and medical devices; 13) present in advertising services, medicines and medical devices, biologically active food additives as unique, the safest and most effective; 14) assert that the safety and effectiveness of the medicinal product are due to its natural origin; 15) cause assumptions that the effectiveness of the service provided, treatment with an advertised medicinal product, biologically active food supplement is guaranteed, and the use of the product is not accompanied by the development of side effects; 16) provide information in advertising that is not directly related to the advertised pharmaceutical service, medicinal product and medical device | gross |
96. | Availability of a document on calibration and (or) verification of a medical device that is a measuring instrument | gross |
97. | Compliance that the medical equipment in use, at the time of acceptance, was new, unused, of the latest or serial model, free of defects | gross |
98. | Availability of a log of the technical condition of medical equipment to be serviced | gross |
99. | Availability of documents confirming current and major repairs | significant |
100. | Availability of documents confirming warranty service (at least thirty-seven months from the date of commissioning and frequency recommended by the manufacturer) consisting of periodic monitoring of the technical condition of medical equipment (at least once a year) | gross |
101. | Availability at the operated medical equipment of: 1) operational documentation (operation manual and service manual); 2) service manual for medical equipment | gross |
102. | Availability of facts of operation of medical equipment that is not provided with service, removed from service, or operation of medical equipment by personnel who do not have special training or have not been trained in the use of medical equipment | gross |
103. | Availability of facts of unreasonable downtime of medical equipment (lack of measures to restore serviceable condition) | significant |
Section 2. In relation to subjects (objects) of pharmaceutical activities engaged in the production of medicines and medical devices | ||
104. | Compliance with technological processes for the production of medicines and medical devices according to the registration dossier | gross |
105. | Availability of state registration in the Republic of Kazakhstan of medicinal substances used in production, with the exception of those produced under the conditions of Good Manufacturing Practice | gross |
106. | Availability of shipping documents for medicines and medical devices | gross |
107. | Carrying out activities for the production of medicines or wholesale distribution of medicines by suppliers of substances or intermediate products | gross |
108. | Compliance of substances, excipients, consumables and packaging materials with the registration dossier | gross |
109. | Carrying out incoming control of raw materials (substances, auxiliary materials), materials, semi-finished products, components; intermediate control during the production process, control of finished pharmaceutical products | gross |
110. | Availability of a quality assurance system in production, documentation and control of its effectiveness | gross |
111. | Ensuring registration of all technological and auxiliary operations during the production of a separate series of medicines and medical devices | gross |
112. | Compliance with the requirements for maintaining documentation of all production processes and materials used in production, the procedure for its storage | gross |
113. | Compliance with stability testing, shelf-life determination and re-inspection of medicinal products | gross |
114. | Ensuring a sufficient number of samples to carry out testing where necessary (arbitration testing) | gross |
115. | Availability of markings indicating the status of manufactured products, initial products, packaging materials | gross |
116. | Carrying out quality control of materials, intermediate products, finished products | gross |
117. | Maintaining a database of side effects of medicines and medical devices | significant |
118. | Availability of a certificate of healthcare specialist for each pharmaceutical worker | gross |
119. | Availability of a state license for pharmaceutical activities and appendices for subtypes of activity or notification on the start of activity. Compliance with the types and subtypes of activities declared upon receipt of the state license and its appendix | gross |
120. | Ensuring storage and transportation in accordance with the conditions established by the manufacturer in the regulatory and technical document on monitoring the quality and safety of medicines, in the instructions for medical use for medicines and medical devices, operational documents (for medical devices), indicated in the labeling of their packages | gross |
121. | Ensuring the safety, storage conditions of various groups of medicines and medical devices and their handling by complying with the requirements for the design, arrangement, composition, size of areas, equipment of premises (zones) for storing medicines and medical devices and their operation, ensuring safety | gross |
122. | Compliance of separate storage of medicines and medical devices from other products in order to avoid any impact on them, protection from the negative effects of light, temperature, moisture and other external factors | gross |
123. | Keeping records of the expiration dates of medicines and medical devices on paper or electronic media | minor |
124. | Storage of medicines and medical devices in designated and clearly marked storage areas | significant |
125. | Providing the storage room, including the refrigeration room (chamber), with appropriate equipment for monitoring temperature, air humidity (thermometers, hygrometers, other types of instruments) and their location on the internal walls of the premises away from heating devices based on the results of testing zones of temperature fluctuations for cold and warm season | gross |
126. | Compliance with separation during storage of all medicines and medical devices depending on the pharmacological group, method of administration, physical state, physicochemical properties, exposure to various environmental factors | gross |
127. | Availability of an isolated place for storing medicines, the decision on the circulation of which has not yet been made, expired, returned, withdrawn from the category suitable for supply, for which there are suspicions of falsification, recalled and rejected | gross |
128. | Ensuring protection from the effects of weather conditions in the areas of acceptance and shipment. Availability of equipment in the areas of acceptance and shipment (ventilation/ air conditioning system, hygrometer, thermometer), equipment for cleaning containers. Availability of an equipped control area for the received products | gross |
129. | Separation of zones for acceptance, quarantine, defects, shipment and storage. Availability of a room in which medicines shall be stored in quarantine, clearly marked and with limited access | gross |
130. | Availability of common fireproof buildings with insulation by fireproof walls from neighboring premises that meet fire safety requirements in the absence of separate storage facilities for flammable substances, providing the premises with supply and exhaust ventilation | gross |
131. | Storage of flammable medicines separately from other medicines: provision of fireproof and stable racks and pallets, storage of flammable and combustible liquids in built-in fireproof cabinets with doors at least 0.7 meters wide and at least 1.2 meters high | gross |
132. | Storage of flammable liquids isolated in separate rooms in glass or metal containers from other groups | gross |
133. | Compliance with the storage of flammable and combustible liquid medicines that should not be stored: 1) in a completely filled container, the degree of filling is not more than 90 percent of the volume. Alcohols in large quantities shall be stored in metal containers, which are filled to no more than 95 percent of the volume; 2) with mineral acids (sulfuric, nitric and other acids), compressed and liquefied gases, flammable substances, as well as with inorganic salts that produce explosive mixtures with organic substances (potassium chlorate, potassium permanganate) | gross |
134. | Compliance with isolated storage of calcium hypochloride, taking into account its properties | gross |
135. | Compliance with the storage of flammable liquids with constant monitoring of the containers condition, their tightness and serviceability | gross |
136. | Implementation of measures during storage of explosive drugs against contamination by dust | gross |
137. | Compliance with separate storage of explosive and flammable medicines containing acids and alkalis | gross |
138. | Ensuring the protection of cylinders with oxygen and flammable gases from heat sources, contact with oil and other fatty substances, and their storage in isolated rooms or under canopies | gross |
139. | Compliance with the conditions for storing dressings in a dry, ventilated area in cabinets, drawers, on racks, shelves, pallets, in conditions that ensure cleanliness | gross |
140. | Compliance with the storage conditions of medical instruments, devices, instruments, equipment in dry heated rooms at room temperature, with a relative air humidity not exceeding 65 percent | gross |
141. | Compliance with the requirements for finishing premises (areas) for storing medicines and ensuring the cleanliness of premises and storage equipment | significant |
142. | Ensuring protection from insects, rodents or other animals and availability of a preventive pest control program | minor |
143. | Separation of rest rooms, dressing rooms, showers and toilets for workers from storage rooms (zones). Food products, drinks, tobacco products, and medicines for personal use shall not be stored in storage rooms (zones). Availability of protective clothing or uniform appropriate for the work performed and personal protective equipment if necessary for employees working in the storage area. Personnel working with dangerous drugs shall undergo special training | significant |
144. | Providing with the necessary equipment and inventory in the premises for the storage of medicines: 1) racks, pallets, shelves, cabinets for storing medicines and medical devices; 2) technological equipment for creating temperature conditions; 3) instruments for recording temperature and humidity; 4) means of mechanization for loading and unloading operations; 5) disinfectants and cleaning equipment to ensure sanitary conditions; 6) other equipment and inventory ensuring sanitary and hygienic conditions, labor protection, safety precautions, fire safety, environmental protection and safety of medicines | gross |
145. | Availability of a document on calibration (verification) of equipment used to control and monitor storage conditions | gross |
146. | Availability of a developed and approved emergency action plan in case of malfunction of the refrigeration room (chamber), refrigeration equipment or power outage, emergency situations | significant |
147. | Availability of developed and approved instructions for cleaning and disinfection of equipment. The equipment is used in good condition and kept in proper cleanliness | significant |
148. | Availability of a person responsible for ensuring the safety of the quality of medicines and medical devices at facilities storing medicines and medical devices | significant |
149. | Presence of a commission for the destruction of medicines and medical devices unsuitable for sale and medical use | significant |
150. | Availability of acts on the destruction of medicines and medical devices unsuitable for sale and medical use | significant |
151. | Availability of labeling of secondary packaging, including the following information: 1) trade name of the medicine; 2) international nonproprietary name (if available) in Kazakh, Russian and English; 3) name of the manufacturer of the medicine, address. The name of the manufacturer and its address shall be indicated in full or abbreviated (city, country). A trademark shall be indicated when it is granted legal protection in the Republic of Kazakhstan. If the manufacturer of the medicine is not its packager, then the name of the packager, date and time of packaging shall be indicated; 4) name of the holder of the registration certificate, his address (city, country); 5) dosage form; 6) dosage, and (or) activity, and (or) concentration (if applicable) of the active pharmaceutical substance (active pharmaceutical substances); 7) the amount of the medicine in the package by weight, volume or number of dosage units, depending on the dosage form and type of packaging; 8) information on the composition of the medicine; 9) for medicinal herbal preparations, which are packaged medicinal plant raw materials, the mass of medicinal plant raw materials and (or) active pharmaceutical substance of plant origin is indicated at their certain humidity; 10) for medicines containing narcotic substances, psychotropic substances, their analogs and precursors, the names of these substances and their content in weight units or percentages are indicated. In single-component medicines, subject to the authenticity of the name of the medicine and the active pharmaceutical substance and indication of its dosage, concentration, activity, the composition of the active pharmaceutical substance shall not be indicated; 11) list of excipients: for parenteral, ophthalmic drugs and drugs for external use, a list of all excipients shall be indicated; for infusion solutions, the qualitative and quantitative composition of all excipients shall be indicated; for other dosage forms, a list of antimicrobial preservatives, dyes, as well as sugars and ethanol shall be indicated; 12) for infusion solutions that contain more than one active pharmaceutical substance, the value of osmolarity and (or) osmolality shall be indicated; 13) method of administration and, depending on the dosage form, route of injection (the method of administration shall not be indicated for tablets and capsules intended for oral administration); 14) precautions; 15) warning notices; 16) storage conditions, storage features and transportation conditions; 17) conditions of release (with a prescription or without a doctor’s prescription); 18) series number; 19) production date (if not entered in the batch number); 20) expiration date: “best before: (date, month, year)” or “(date, month, year)”; The expiration date is indicated as “best before (month, year)” or “(month, year)”, while the expiration date is determined up to and including the last day of the specified month; 21) registration number of the medicinal product in the form of the designation “RK-MP-”; 22) barcode (if available); 23) means of identification or a material medium containing means of identification | gross |
152. | Availability of labeling of primary packaging indicating the following information: 1) trade name of the medicinal product, indicating the dosage, activity or concentration; 2) international nonproprietary name (if available) in the state, Russian and English languages; 3) the name of the manufacturer of the medicinal product and (or) its trademark; 4) series number; 5) expiration date “month, year” or “date, month, year” Additional information that is identical to the information printed on the secondary packaging shall be placed. Intermediate packaging, which does not allow the information on the primary packaging to be read without compromising its integrity, repeats the information indicated on the primary packaging | gross |
153. | Organization of work to monitor adverse reactions and (or) lack of effectiveness of medicines and medical devices, appointment of responsible persons for monitoring side effects of medicines and medical devices | significant |
154. | Provision by the responsible person to the authorized organization of information about side effects and (or) lack of effectiveness of medicines and medical devices. Transmission of report cards through the portal of an authorized organization online containing a mandatory minimum amount of information | significant |
155. | Compliance with the deadlines for submitting a completed report card about adverse reactions (actions) and (or) effectiveness to the authorized organization in cases of detection | significant |
156. | Absence of facts of purchase, production, storage, advertising, use, provision and sale of medicines and medical devices that have not passed state registration in the Republic of Kazakhstan | gross |
157. | Absence of facts of production, import, storage, use and sale of counterfeit medicines and medical devices | gross |
158. | Absence of facts of sales of medicines and medical devices, the quality of which is not confirmed by a conclusion on safety and quality | gross |
159. | Absence of facts of storage, use and sale of expired medicines and medical devices | gross |
160. | Compliance of the medicine with the requirements of the regulatory document on control of the quality and safety of the medicine and medical device (based on the results of assessing the safety and quality of samples withdrawn as doubt) | gross |
161. | Compliance with the requirements for storage, accounting, destruction of medicines containing narcotic drugs, psychotropic substances and precursors (including substances): The destruction of narcotic drugs, psychotropic substances, their analogues and precursors can be carried out in cases when: 1) the shelf life of the narcotic drug, psychotropic substance and precursors has expired; 2) narcotic drugs, psychotropic substances, precursors have been subjected to chemical or physical influence, resulting in their unusability, excluding the possibility of their restoration or processing; 3) confiscated, discovered and withdrawn from illegal traffic of narcotic drugs, psychotropic substances, their analogs and precursors do not represent medical, scientific or other value and cannot be processed, as well as in other cases provided for by the legislation of the Republic of Kazakhstan. | gross |
162. | Availability of a list of persons who have conclusions from psychiatrists and narcologists about the absence of drug addiction, substance abuse, chronic alcoholism, as well as about suitability for carrying out activities related to narcotic drugs, psychotropic substances and their precursors and the conclusion of the internal affairs bodies to conduct the relevant inspection | gross |
163. | Storage rooms, safes and cabinets shall be kept closed. After the end of the working day, they shall be sealed and (or) stamped. Keys, seal and (or) stamp shall be kept by the responsible person | gross |
164. | Availability of a first aid kit | minor |
165. | Availability of a sign indicating the name of the subject of pharmaceutical activity, its organizational and legal form and mode of operation in the state and Russian languages | minor |
166. | Availability of information about the telephone numbers and addresses of territorial subdivisions of the state body in the field of circulation of medicines and medical devices in a place convenient for the public to familiarize themselves | minor |
167. | Ensuring traceability of medicines marked with identification means by providing the drug administration and entities in the field of circulation of medicines and medical devices with information on the introduction into circulation, sale and (or) transfer, as well as on the withdrawal from circulation of labeled medicines in the territory of the Republic of Kazakhstan | gross |
168. | Compliance with the rules for advertising medicines and medical devices: 1) advertising of medicines and medical devices shall be reliable, recognizable without special knowledge or the use of special means, exclude comparisons with other pharmaceutical services, medicines and medical devices, do not mislead consumers by abusing their trust, including with regard to characteristics, composition, consumer properties, cost (price), expected results of use, results of researches and testings; 2) advertising of medicines and medical devices is provided in the Kazakh and Russian languages, contains complete and reliable information about the medicine or medical device, complies with the instructions for medical use of the medicine (insert leaflet), instructions for medical use or operational document for the medical product; 3) availability of a conclusion on the compliance of advertising of medicines and medical devices with the requirements of the legislation of the Republic of Kazakhstan in the field of healthcare | gross |
169. | Prohibition of advertising of medicines and medical devices: 1) not registered in the Republic of Kazakhstan; 2) prescription medicines in the media; 3) distribution for advertising purposes of samples of medicines released with a doctor’s prescription; 4) the use of children, their images and voices in advertising of medicines and medical devices, except for medicines and medical devices for children; 5) distribution and placement of advertising of medicines and medical devices in public transport, organizations not related to their purpose, use and release, with the exception of advertising of medicines at medical, pharmaceutical conferences, congresses, symposiums and other scientific meetings; 6) placement of advertising information on industrial products, prescription forms; 7) placement of outdoor (visual) advertising of medicines and medical products; 8) the use of medical workers authorized to prescribe medicines and medical devices as distributors of advertising, with the exception of cases of providing reliable information about medicines and medical devices for scientific or educational purposes, as well as for the purpose of informing patients; 9) advertising of pharmaceutical services in the absence of a license to carry out the relevant type of activity; 10) advertising of pharmaceutical services provided by persons who do not have a certificate as a specialist in the field of healthcare, including foreign specialists; 11) indication in advertising for the population of treatment methods for the following diseases: sexually transmitted diseases, cancer, mental, behavioral disorders (diseases), dangerous infectious diseases, HIV infection, tuberculosis, diabetes mellitus; 12) refer in advertising to the recommendations of scientists, healthcare professionals, as well as government officials who may encourage the use and (or) prescription of medicines and medical devices; 13) present in advertising the services, medicines and medical devices, biologically active food additives as unique, the safest, and most effective; 14) assert that the safety and effectiveness of the medicine are due to its natural origin; 15) cause assumptions that the effectiveness of the service provided, treatment with an advertised medicine, biologically active food additive is guaranteed, and the use of the product is not accompanied by the development of side effects; 16) provide information in advertising that is not directly related to the advertised pharmaceutical service, medicine, or medical device | gross |
170. | Compliance with the manufacturer's maximum price | gross |
171. | Availability of a certificate of compliance with the requirements of the Good Manufacturing Practice (GMP) Standard | gross |
Section 3. In relation to subjects (objects) of pharmaceutical activities engaged in the manufacture of medicines and medical devices | ||
172. | Availability of a pharmacist-analyst’s workplace equipped with a standard set of measuring instruments, testing equipment, laboratory glassware, and auxiliary materials | gross |
173. | Implementation of preventive (cautionary) measures, acceptance control of raw materials (medicinal substance, excipient), written, organoleptic, random survey control, random physical and chemical control, control during the release of manufactured medicines | gross |
174. | Availability and maintenance of checklists for the manufacture of medicines according to prescriptions and requirements of medical organizations | significant |
175. | Availability and maintenance of a numbered, laced, sealed, and signed by the head of the pharmacy journal for recording the results of organoleptic, physical, and chemical control | significant |
176. | Availability of state registration in the Republic of Kazakhstan for medicinal substances used in manufacturing, with the exception of those produced under the conditions of Good Manufacturing Practice | gross |
177. | Carrying out activities by suppliers of substances for the production of medicines or wholesale sales of medicines | gross |
178. | Maintaining and monitoring the expiration dates of medicines and medical devices | significant |
179. | Providing technology for the manufacture of a medicinal product, in accordance with the requirements of general articles of the State Pharmacopoeia of the Republic of Kazakhstan | gross |
180. | Implementation of preventive (precautionary) measures: 1) compliance with the conditions for aseptic manufacturing of medicinal products; 2) ensuring the serviceability and accuracy of weighing instruments, carrying out their annual verification; 3) ensuring proper conditions for obtaining, collecting, storing purified water, water for injection, correct labeling of the container in the form of indicating the date of receipt, the analysis number, and the signature of the person who performed the analysis on the tag; 4) compliance with the terms and conditions of reagents storage, standard and titrated solutions, and their correct design (on the labels, in addition to the name, the concentration, molarity, date of receipt, expiration date, storage conditions, and by whom it was manufactured shall be indicated); 5) determination of deviations in the tested medicinal products using measuring instruments of the same type (with the same metrological characteristics) as when they were manufactured in pharmacies; 6) proper processing, filling, design of burette installation and rods | gross |
181. | Design of glass stoppered bottles (pharmaceutical containers) as follows: 1) name, country and manufacturing plant, series number of the manufacturing plant, number and validity period of the product conformity certificate, expiration date of the medicinal substance, date of filling, signature of the person who filled the bar and verified the authenticity of the medicinal substance is indicated on the glass stoppered bottles in the storage premises; 2) the date the glass stoppered bottle was filled out, the signature of the person who filled the glass stoppered bottle and verified the authenticity of the medicinal substance and excipients on the glass stoppered bottles with medicinal substances and excipients, which are contained in the assistant’s room is indicated; 3) the highest single and daily doses are additionally indicated on the glass stoppered bottles with narcotic drugs, psychotropic substances, precursors, toxic substances; 4) the number of units of action in one gram of medicinal plant material or in one milliliter of solution is indicated on glass stoppered bottles with medicinal substances containing cardiac glycosides; 5) the inscription: “For sterile medicinal products” is indicated on glass stoppered bottles with medicinal substances intended for the manufacture of medicinal products requiring aseptic manufacturing conditions; 6) the percentage of moisture; on cylinders with liquids (hydrogen peroxide solution, ammonia solution, formaldehyde) the actual content of the active substance is indicated on containers with medicinal substances containing moisture; 7) glass stoppered bottles with solutions, tinctures and liquid semi-finished products are provided with drop meters or pipettes, indicating the number of drops established by weighing in a certain volume | gross |
182. | Availability and maintenance of a journal for recording the results of control of medicinal substances for authenticity | significant |
183. | Implementation of control over compliance with the technology of manufacturing medicines by the pharmacist-technologist | gross |
184. | Carrying out acceptance control of raw materials (drug substance, excipients) used for the manufacture of medicinal products (bill of lading, quality certificate of the manufacturer), compliance of series on samples of medicinal substances and excipients with the series specified in the accompanying documentation, compliance with storage conditions, transportation, as well as identification of medicinal substances and auxiliary materials according to the indicators “Packaging”, “Labelling” and “Description” | significant |
185. | Carrying out written control of medicinal products manufactured in a pharmacy by filling out a control sheet immediately after the preparation of the medicinal product. The checklist indicates: 1) date of manufacture; 2) number of the prescription or requirement of the medical organization indicating the name of the department; 3) names of the medicinal substances taken, their quantity, total volume or weight, number of doses; 4) signatures of the person who manufactured, packaged and tested the medicinal product. On the control sheet, the names of narcotic drugs, poisonous, psychotropic substances, and precursors are underlined in red pencil, and the letter “D” is placed on medical products for children. The control sheet is filled out in Latin in accordance with the sequence of manufacturing technology. All calculations are written down on the back of the check sheet | gross |
186. | Conducting random survey control of medical products manufactured in a pharmacy | gross |
187. | Carrying out organoleptic control in terms of appearance, color, smell, uniformity, absence of visible mechanical inclusions in solutions | significant |
188. | Carrying out random physical control by checking the total weight or volume of the medicinal product, the number and weight of individual doses included in this medicinal product (but not less than three doses), and the quality of closure. The following shall be subject to selective physical control: 1) each series of packaging of industrial products and in-house pharmaceutical preparations in the amount of three to five packages, including packaging of homeopathic medicines for compliance with the norms of deviations permissible in the manufacture of medicines (including homeopathic) in a pharmacy and the norms of deviations permissible during packaging industrial products; 2) at least three percent of medicinal products manufactured according to prescriptions (requirements) in one working day; 3) the number of homeopathic granules in a certain mass of the sample; 4) each series of medicinal products requiring sterilization, after packaging before sterilization in an amount of at least five vials (bottles) for mechanical inclusions (mobile insoluble substances, except for gas bubbles, accidentally present in solutions) | gross |
189. | Carrying out primary and secondary inspection for mechanical inclusions during the manufacturing process of solutions | gross |
190. | Carrying out chemical control according to the following indicators: 1) authenticity, purity tests and acceptable limits of impurities (qualitative analysis); 2) quantitative determination (quantitative analysis) of medicinal substances included in its composition | gross |
191. | Providing a complete chemical analysis of purified water | gross |
192. | Exercising control during release by checking all manufactured medicinal products, including homeopathic ones, for compliance with: 1) packaging of medicinal products based on the physical and chemical properties of the medicinal substances included in them; 2) the doses indicated in the prescription, including the highest single doses, the highest daily doses of medicinal products depending on the patient’s age; 3) numbers on the prescription and numbers on the label; 4) the patient’s name on the receipt, name on the label and prescription; 5) registration of medicinal products | gross |
193. | Ensuring registration of the results of control of individual stages of manufacturing solutions for injections and infusions in the logbook for recording the results of control of individual stages of manufacturing solutions for injections and infusions | gross |
194. | Availability of a range of concentrates, semi-finished products and in-pharmacy procurement of medicinal products manufactured in a pharmacy, annually approved by an accredited testing laboratory, with which an agreement on control and analytical services has been concluded | gross |
195. | Availability of a specialist certificate in the field of healthcare for each pharmaceutical worker | gross |
196. | Availability of a state license for pharmaceutical activities and appendices for subtypes of activity or notification of the start of activity. Compliance with the types and subtypes of activities declared upon receipt of the state license and its appendix | gross |
197. | Ensuring storage and transportation in accordance with the conditions established by the manufacturer in the regulatory and technical document on monitoring the quality and safety of medicines, in the instructions for medical use for medicines and medical devices, operational documents (for medical devices), indicated in the labeling of their packages | gross |
198. | Ensuring the safety, storage conditions of various groups of medicines and medical devices and their handling by complying with the requirements for the design, arrangement, composition, size of areas, equipment of premises (zones) for storing medicines and medical devices and their operation, ensuring safety | gross |
199. | Observance of separate storage of medicines and medical devices from other products in order to avoid any impact on them, protection from the negative effects of light, temperature, moisture and other external factors | gross |
200. | Keeping records of the expiration dates of medicines and medical devices on paper or electronic media | minor |
201. | Carrying out storage of medicines and medical devices in designated and clearly marked storage zones | significant |
202. | Providing the storage room, including the refrigeration room (chamber), with appropriate equipment for monitoring temperature, air humidity (thermometers, hygrometers, other types of instruments), and their location on the internal walls of the premises away from heating devices based on the results of testing zones of temperature fluctuations for cold and warm season | gross |
203. | Compliance with separation during storage of all medicines and medical devices depending on the pharmacological group, method of administration, physical state, physicochemical properties, exposure to various environmental factors | gross |
204. | Availability of an isolated place for storing medicines, the decision on the circulation of which has not yet been made, expired, returned, withdrawn from the category suitable for supply, in relation of which there are suspicions of falsification, recalled and rejected | gross |
205. | Ensuring protection from the effects of weather conditions in the zones of acceptance and shipment. Availability of equipment in the zones of acceptance and shipment (ventilation/ air conditioning system, hygrometer, thermometer), equipment for cleaning containers. Availability of an equipped control zone for the received products | gross |
206. | Separation of acceptance, quarantine, defective, shipping and storage zones. Availability of a room in which medicines are stored in quarantine, clearly marked and with limited access | gross |
207. | Availability of common fireproof buildings with insulation by fireproof walls from neighboring premises that meet fire safety requirements in the absence of separate storage facilities for flammable substances, providing the premises with supply and exhaust ventilation | gross |
208. | Storage of flammable medicines separately from other medicines: provision with fireproof and stable racks and pallets, storage of flammable and combustible liquids in built-in fireproof cabinets with doors at least 0.7 meters wide and at least 1.2 meters high | gross |
209. | Storage of flammable liquids isolated in separate rooms in glass or metal containers from other groups | gross |
210. | Compliance with the storage of flammable and combustible liquid medicines that should not be stored: 1) in a completely filled container, the degree of filling is not more than 90 percent of the volume. Alcohols in large quantities shall be stored in metal containers, which are filled to no more than 95 percent of the volume; 2) with mineral acids (sulfuric, nitric and other acids), compressed and liquefied gases, flammable substances, as well as with inorganic salts that produce explosive mixtures with organic substances (potassium chlorate, potassium permanganate) | gross |
211. | Compliance with isolated storage of calcium hypochloride, taking into account its properties | gross |
212. | Compliance with the storage of flammable liquids with constant monitoring of the condition of containers, their tightness and serviceability | gross |
213. | Implementation of measures during storage of explosive drugs against contamination by dust | gross |
214. | Compliance with separate storage of explosive and flammable medicines containing acids and alkalis | gross |
215. | Ensuring the protection of cylinders with oxygen and flammable gases from heat sources, contact with oil and other fatty substances, and their storage in isolated rooms or under canopies | gross |
216. | Compliance with the conditions for storing dressings in a dry, ventilated area in cabinets, drawers, on racks, pallets, shelves, in conditions that ensure cleanliness | gross |
217. | Compliance with the storage conditions of medical instruments, devices, instruments, equipment in dry heated rooms at room temperature, with a relative air humidity not exceeding 65 percent | gross |
218. | Compliance with the requirements for finishing premises (zones) for storing medicines and ensuring the cleanliness of premises and storage equipment | significant |
219. | Ensuring protection from insects, rodents or other animals and availability of a preventive pest control program | minor |
220. | Separation of rest rooms, dressing rooms, showers, and toilets for workers from storage rooms (zones). Food products, drinks, tobacco products, and medicines for personal use shall not be stored in storage rooms (zones). Availability of protective clothing or uniform appropriate for the work performed and personal protective equipment if necessary for employees working in the storage zone. Personnel working with dangerous drugs shall undergo special training | significant |
221. | Providing with the necessary equipment and inventory in the premises of medicines storage: 1) racks, pallets, shelves, cabinets for storing medicines and medical devices; 2) technological equipment for creating temperature conditions; 3) instruments for recording temperature and humidity; 4) means of mechanization for loading and unloading operations; 5) disinfectants and cleaning equipment to ensure sanitary conditions; 6) other equipment and inventory ensuring sanitary and hygienic conditions, labor protection, safety precautions, fire safety, environmental protection, and safety of medicines | gross |
222. | Availability of a document on calibration (verification) of equipment used to control and monitor storage conditions | gross |
223. | Availability of a developed and approved emergency action plan in case of malfunction of the refrigeration room (chamber), refrigeration equipment or power outage, emergency situations | significant |
224. | Availability of developed and approved instructions for cleaning and disinfection of equipment. The equipment shall be used in good condition and kept in proper cleanliness | significant |
225. | Availability of a person responsible for ensuring the safety of quality of medicines and medical devices at facilities storing medicines and medical devices | significant |
226. | Presence of a commission for the destruction of medicines and medical devices unsuitable for sale and medical use | significant |
227. | Availability of acts on the destruction of medicines and medical devices unsuitable for sale and medical use | significant |
228. | Availability of secondary package labeling, including the following information: 1) trade name of the medicine; 2) international nonproprietary name (if available) in Kazakh, Russian and English; 3) name of the manufacturer of the medicine, address. The name of the manufacturer and its address are indicated in full or abbreviated (city, country). A trademark shall be indicated when it is granted legal protection in the Republic of Kazakhstan. If the manufacturer of the medicinal product is not its packager, then the name of the packager, date and time of packaging shall be indicated; 4) name of the holder of the registration certificate, his address (city, country); 5) dosage form; 6) dosage, and (or) activity, and (or) concentration (if applicable) of the active pharmaceutical substance (active pharmaceutical substances); 7) the amount of the medicinal product in the package by weight, volume or number of dosage units, depending on the dosage form and type of packaging; 8) information on the composition of the medicinal product; 9) for medicinal herbal preparations, which are packaged medicinal plant raw materials, the mass of medicinal plant raw materials and (or) active pharmaceutical substance of plant origin shall be indicated at their certain humidity; 10) for medicinal products containing narcotic substances, psychotropic substances, their analogs and precursors, the names of these substances and their content in weight units or percentages shall be indicated. In single-component medicinal products, subject to the authenticity of the medicinal product name and active pharmaceutical substance and indication of its dosage, concentration, activity, the composition of the active pharmaceutical substance shall not be indicated; 11) list of excipients: for parenteral, ophthalmic drugs and drugs for external use, a list of all excipients shall be indicated; for infusion solutions, the qualitative and quantitative composition of all excipients shall be indicated; for other dosage forms, a list of antimicrobial preservatives, dyes, as well as sugars and ethanol shall be indicated; 12) for infusion solutions that contain more than one active pharmaceutical substance, the value of osmolarity and (or) osmolality shall be indicated; 13) method of administration and, depending on the dosage form, route of injection (the method of administration shall not be indicated for tablets and capsules intended for oral administration); 14) precautions; 15) warning notices; 16) storage conditions, storage features and transportation conditions; 17) conditions of release (with a prescription or without a doctor’s prescription); 18) series number; 19) production date (if not entered in the batch number); 20) expiration date: “best before: (date, month, year)” or “(date, month, year)”; The expiration date is indicated as “best before (month, year)” or “(month, year)”, with the expiration date determined up to and including the last day of the specified month; 21) registration number of the medicinal product in the form of the designation “RK-MP-”; 22) barcode (if available); 23) means of identification or a material medium containing means of identification | gross |
229. | Availability of primary package labeling indicating the following information: 1) trade name of the medicinal product, indicating the dosage, activity or concentration; 2) international nonproprietary name (if available) in the state, Russian and English languages; 3) name of the organization-manufacturer of the medicinal product and (or) its trademark; 4) series number; 5) expiration date “month, year” or “date, month, year” Additional information shall be placed that is identical to the information printed on the secondary packaging. Intermediate packaging, which does not allow the information on the primary packaging to be read without compromising its integrity, repeats the information indicated on the primary packaging | gross |
230. | Organization of work to monitor adverse reactions and (or) lack of effectiveness of medicines and medical devices, appointment of responsible persons for monitoring side effects of medicines and medical devices | significant |
231. | Provision by the responsible person to the authorized organization of information about side effects and (or) lack of effectiveness of medicines and medical devices. Transmission of report cards through the portal of an authorized organization online containing a mandatory minimum amount of information | significant |
232. | Compliance with the deadlines for submitting a completed report card about adverse reactions (actions) and (or) effectiveness to the authorized organization in cases of detection | significant |
233. | Absence of facts of purchase, production, storage, advertising, use, provision and sale of medicines and medical devices that have not passed state registration in the Republic of Kazakhstan | gross |
234. | Absence of facts of production, import, storage, use and sale of counterfeit medicines and medical devices | gross |
235. | Absence of facts of sales of medicines and medical devices, the quality of which is not confirmed by a conclusion on safety and quality | gross |
236. | Absence of facts of storage, use and sale of expired medicines and medical devices | gross |
237. | Compliance of the medicine with the requirements of the regulatory document on control of the quality and safety of the medicine and medical device (based on the results of assessing the safety and quality of samples withdrawn as doubt) | gross |
238. | Compliance with the requirements for storage, accounting, destruction of medicines containing narcotic drugs, psychotropic substances and precursors (including substances): The destruction of narcotic drugs, psychotropic substances, their analogues and precursors can be carried out in cases when: 1) the shelf life of the narcotic drug, psychotropic substance and precursors has expired; 2) narcotic drugs, psychotropic substances, precursors have been subjected to chemical or physical influence, resulting in their unusability, excluding the possibility of their restoration or processing; 3) confiscated, discovered and withdrawn from the illegal traffic of narcotic drugs, psychotropic substances, their analogs and precursors do not represent medical, scientific or other value and cannot be processed, as well as in other cases provided for by the legislation of the Republic of Kazakhstan. | gross |
239. | Availability of a list of persons who have conclusions from psychiatrists and narcologists about the absence of drug addiction, substance abuse, chronic alcoholism, as well as about suitability for carrying out activities related to narcotic drugs, psychotropic substances and their precursors and the conclusion of the internal affairs bodies to conduct the relevant inspection | gross |
240. | Storage rooms, safes and cabinets shall be kept closed. After the end of the working day, they shall be sealed and (or) stamped. Keys, seal and (or) stamp shall be kept by the responsible person | gross |
241. | Availability of a first aid kit | minor |
242. | Availability of a sign indicating the name of the subject of pharmaceutical activity, its organizational and legal form and mode of operation in the state and Russian languages | minor |
243. | Availability of information about the telephone numbers and addresses of territorial divisions of the state body in the field of circulation of medicines and medical devices in a place convenient for the public to familiarize | minor |
244. | Ensuring traceability of medicines marked with identification means by providing the drug administration and entities in the field of circulation of medicines and medical devices with information on the introduction into circulation, sale and (or) transfer, as well as on the withdrawal from circulation of labeled medicines in the territory of the Republic of Kazakhstan | gross |
245. | Compliance with the rules for advertising medicines and medical devices: 1) advertising of medicines and medical devices is reliable, recognizable without special knowledge or the use of special means, exclude comparisons with other pharmaceutical services, medicines and medical devices, do not mislead consumers by abusing their trust, including with regard to characteristics, composition, consumer properties, cost (price), expected results of use, results of research and testing; 2) advertising of medicines and medical devices is provided in the Kazakh and Russian languages, contains complete and reliable information about the medicine or medical device, complies with the instructions for medical use of the medicine (insert leaflet), instructions for medical use or operational document for the medical product; 3) availability of a conclusion on the compliance of advertising of medicines and medical devices with the requirements of the legislation of the Republic of Kazakhstan in the field of healthcare | gross |
246. | Prohibition of advertising of medicines and medical devices: 1) not registered in the Republic of Kazakhstan; 2) prescription medicines in the mass media; 3) distribution for advertising purposes of samples of medicines dispensed with a doctor’s prescription; 4) the use of children, their images and voices in advertising of medicines and medical devices, except for medicines and medical devices for children; 5) distribution and placement of advertising of medicines and medical devices in public transport, organizations not related to their purpose, use and dispensing, with the exception of advertising of medicines at medical, pharmaceutical conferences, congresses, symposiums and other scientific meetings; 6) placement of advertising information on industrial products, prescription forms; 7) placement of outdoor (visual) advertising of medicines and medical devices; 8) the use of medical workers authorized to prescribe medicines and medical devices as distributors of advertising, with the exception of cases of providing reliable information about medicines and medical devices for scientific or educational purposes, as well as for the purpose of informing patients; 9) advertising of pharmaceutical services in the absence of a license to carry out the relevant type of activity; 10) advertising of pharmaceutical services provided by persons who do not have a certificate as a specialist in the field of healthcare, including foreign specialists; 11) indication in advertising for the population of treatment methods for the following diseases: sexually transmitted diseases, cancer, mental, behavioral disorders (diseases), dangerous infectious diseases, HIV infection, tuberculosis, diabetes mellitus; 12) refer in advertising to the recommendations of scientists, healthcare professionals, as well as government officials who may encourage the use and (or) prescription of medicines and medical devices; 13) present in advertising services, medicines and medical products, biologically active food additives as unique, the safest and most effective; 14) assert that the safety and effectiveness of the medicinal product are due to its natural origin; 15) cause assumptions that the effectiveness of the service provided, treatment with an advertised medicinal product, biologically active food supplement is guaranteed, and the use of the product is not accompanied by the development of side effects; 16) provide information in advertising that is not directly related to the advertised pharmaceutical service, medicine and medical device | gross |
Section 4. In relation to subjects (objects) of pharmaceutical activities engaged in wholesale sales of medicines and medical devices | ||
247. | Availability and functioning of a documentation system for tracking the receipt and shipment of medicines and medical devices | gross |
248. | Ensuring the provision of a copy of the product conformity certificate upon request of the subject. Certificates of conformity of medicines and medical devices shall be stored for the duration of its validity plus one year and shall be available to consumers and (or) state regulatory bodies | significant |
249. | Purchasing medicines and medical devices from entities that have a license for pharmaceutical activities and an appendix to the license for subtypes of activity: production of medicines, wholesale sales of medicines, or who have notified the start of activities for the wholesale sale of medical devices | gross |
250. | Implementation of the sale of medicines and medical devices to entities having a license for pharmaceutical or medical activities or who have notified about the start of activities for the sale of medical devices | gross |
251. | The sale of medicinal substances shall be carried out to pharmacies that have a license for pharmaceutical activities with the right to manufacture, as well as organizations for the production of medicines that have a license for pharmaceutical activities with the right to produce medicines | gross |
252. | Carrying out wholesale sales of medical devices related to measuring instruments, in the availability of a certificate on approval of the type of measuring instruments, or a certificate of metrological certification of medical measuring equipment | gross |
253. | Provision of vehicles and equipment used for transportation and compliance with the purposes of their use, to protect products from undesirable effects that lead to loss of quality or violate the integrity of packaging, as well as: 1) the possibility of their identification and safety assessment has not been lost; 2) were not contaminated with other medicines (dosages), substances and did not contaminate themselves; 3) were protected and not exposed to environmental factors. The vehicle and its equipment shall be kept clean and treated with detergents and disinfectants as needed | significant |
254. | Compliance with storage conditions during transportation necessary to ensure the quality, safety and effectiveness of medicines, as well as to prevent the risk of counterfeit medicines entering the supply chain | gross |
255. | Availability of temperature control devices in vehicles in case of supplies of medicines requiring special transportation conditions. Instrument readings shall be recorded throughout transportation and shall be documented | gross |
256. | Ensuring the protection of medicines and medical devices from environmental factors (precipitation, dust, sunlight, mechanical damage). Medicines and medical devices prepared for transportation shall be packaged in group containers (cardboard boxes or stacks) with subsequent packaging in transport packaging (boxes, cartons, wrapping paper) that meets the requirements of the regulatory document | gross |
257. | Ensuring the execution of shipping documents containing the following information for each item, batch (series) of products: name; dosage (for a medicine); packaging; quantity, unit price; sum; series; best before date; number and validity period of the certificate of conformity (for a medicine or medical device). Corrections, additions, and blots in shipping documents shall not be allowed. | gross |
258. | Compliance with the maximum price for the trade name of a medicine during wholesale sales | gross |
259. | Availability of a specialist certificate in the field of healthcare for each pharmaceutical worker | gross |
260. | Availability of a state license for pharmaceutical activities and appendices for subtypes of activity or notification on the start of activity. Compliance with the types and subtypes of activities declared upon receipt of the state license and its appendix | gross |
261. | Ensuring storage and transportation in accordance with the conditions established by the manufacturer in the regulatory and technical document on monitoring the quality and safety of medicines, in the instructions for medical use for medicines and medical devices, operational documents (for medical devices), indicated in the labeling of their packages | gross |
262. | Ensuring the safety, storage conditions of various groups of medicines and medical devices and their handling by complying with the requirements for the design, arrangement, composition, size of areas, equipment of premises (zones) for storing medicines and medical devices and their operation, ensuring safety | gross |
263. | Observance of separate storage of medicines and medical devices from other products in order to avoid any impact on them, protection from the negative effects of light, temperature, moisture and other external factors | gross |
264. | Keeping records of the expiration dates of medicines and medical devices on paper or electronic media | minor |
265. | Storage of medicines and medical devices in designated and clearly marked storage areas | significant |
266. | Providing the storage room, including the refrigeration room (chamber), with appropriate equipment for monitoring temperature, air humidity (thermometers, hygrometers, other types of instruments) and their location on the internal walls of the premises away from heating devices based on the results of testing zones of temperature fluctuations for cold and warm season | gross |
267. | Compliance with separation during storage of all medicines and medical devices depending on the pharmacological group, method of administration, physical state, physicochemical properties, exposure to various environmental factors | gross |
268. | Availability of an isolated place for storing medicines, the decision on the circulation of which has not yet been made, expired, returned, withdrawn from the category suitable for supply, for which there are suspicions of falsification, recalled and rejected | gross |
269. | Ensuring protection from the effects of weather conditions in the zones of acceptance and shipment. Availability of equipment in the zones of acceptance and shipment (ventilation/ air conditioning system, hygrometer, thermometer), equipment for cleaning containers. Availability of an equipped control zone for the received products | gross |
270. | Separation of acceptance, quarantine, defective, shipping and storage zones. Availability of a room in which medicines shall be stored in quarantine, with clear markings and limited access. | gross |
271. | Availability of common fireproof buildings with insulation by fireproof walls from neighboring premises that meet fire safety requirements in the absence of separate storage facilities for flammable substances, providing the premises with supply and exhaust ventilation | gross |
272. | Storage of flammable medicines separately from other medicines: provision of fireproof and stable racks and pallets, storage of flammable and combustible liquids in built-in fireproof cabinets with doors at least 0.7 meters wide and at least 1.2 meters high | gross |
273. | Storage of flammable liquids isolated in separate rooms in glass or metal containers from other groups | gross |
274. | Compliance with the storage of flammable and combustible liquid medicines that should not be stored: 1) in a completely filled container, the degree of filling is not more than 90 percent of the volume. Alcohols in large quantities shall be stored in metal containers, which are filled to no more than 95 percent of the volume; 2) with mineral acids (sulfuric, nitric and other acids), compressed and liquefied gases, flammable substances, as well as with inorganic salts that produce explosive mixtures with organic substances (potassium chlorate, potassium permanganate) | gross |
275. | Compliance with isolated storage of calcium hypochloride, taking into account its properties | gross |
276. | Compliance with the storage of flammable liquids with constant monitoring of the containers condition, their tightness and serviceability | gross |
277. | Implementation of measures during storage of explosive drugs against contamination by dust | gross |
278. | Compliance with separate storage of explosive and flammable medicines containing acids and alkalis | gross |
279. | Ensuring the protection of cylinders with oxygen and flammable gases from heat sources, contact with oil and other fatty substances, and their storage in isolated rooms or under canopies | gross |
280. | Compliance with the conditions for storing dressings in a dry, ventilated area in cabinets, drawers, on racks, pallets, shelves, in conditions that ensure cleanliness | gross |
281. | Compliance with the storage conditions of medical instruments, devices, instruments, equipment in dry heated rooms at room temperature, with a relative air humidity not exceeding 65 percent | gross |
282. | Compliance with the requirements for finishing premises (areas) for storing medicines and ensuring the cleanliness of premises and storage equipment | significant |
283. | Ensuring protection from insects, rodents or other animals and availability of a preventive pest control program | minor |
284. | Separation of rest rooms, dressing rooms, showers and toilets for workers from storage rooms (zones). Food products, drinks, tobacco products, and medicines for personal use shall not be stored in storage rooms (zones). Availability of protective clothing or uniform appropriate for the work performed and personal protective equipment if necessary for employees working in the storage zone. Personnel working with dangerous drugs shall undergo special training | significant |
285. | Providing with the necessary equipment and inventory in the premises of medicines storage: 1) racks, pallets, shelves, cabinets for storing medicines and medical devices; 2) technological equipment for creating temperature conditions; 3) instruments for recording temperature and humidity; 4) means of mechanization for loading and unloading operations; 5) disinfectants and cleaning equipment to ensure sanitary conditions; 6) other equipment and inventory ensuring sanitary and hygienic conditions, labor protection, safety precautions, fire safety, environmental protection and safety of medicines | gross |
286. | Availability of a document on calibration (verification) of equipment used to control and monitor storage conditions | gross |
287. | Availability of a developed and approved emergency action plan in case of malfunction of the refrigeration room (chamber), refrigeration equipment or power outage, emergency situations | significant |
288. | Availability of developed and approved instructions for cleaning and disinfection of equipment. The equipment shall be used in good condition and kept in proper cleanliness | significant |
289. | Availability of a person responsible for ensuring the safety of the quality of medicines and medical devices at facilities carrying out storage of medicines and medical devices | significant |
290. | Presence of a commission for the destruction of medicines and medical devices unsuitable for sale and medical use | significant |
291. | Availability of acts on the destruction of medicines and medical devices unsuitable for sale and medical use | significant |
292. | Availability of secondary package labeling, including the following information: 1) trade name of the medicine; 2) international nonproprietary name (if available) in Kazakh, Russian and English; 3) name of the manufacturer of the medicine, address. Name of the manufacturer and its address shall be indicated in full or abbreviated (city, country). A trademark shall be indicated when it is granted legal protection in the Republic of Kazakhstan. If the manufacturer of the medicinal product is not its packager, then the name of the packager, date and time of packaging shall be indicated; 4) name of the holder of the registration certificate, his address (city, country); 5) dosage form; 6) dosage, and (or) activity, and (or) concentration (if applicable) of the active pharmaceutical substance (active pharmaceutical substances); 7) the amount of the medicinal product in the package by weight, volume or number of dosage units, depending on the dosage form and type of packaging; 8) information on the composition of the medicinal product; 9) for medicinal herbal preparations, which are packaged medicinal plant raw materials, the mass of medicinal plant raw materials and (or) active pharmaceutical substance of plant origin shall be indicated at their certain humidity; 10) for medicinal products containing narcotic substances, psychotropic substances, their analogs and precursors, the names of these substances and their content in weight units or percentages shall be indicated. In single-component medicinal products, subject to the authenticity of the name of the medicinal product and the active pharmaceutical substance and the indication of its dosage, concentration, activity, the composition of the active pharmaceutical substance shall not be indicated; 11) list of excipients: for parenteral, ophthalmic medicinal products and drugs for external use, a list of all excipients shall be indicated; for infusion solutions, the qualitative and quantitative composition of all excipients shall be indicated; for other dosage forms, a list of antimicrobial preservatives, dyes, as well as sugars and ethanol shall be indicated; 12) for infusion solutions that contain more than one active pharmaceutical substance, the value of osmolarity and (or) osmolality shall be indicated; 13) method of administration and, depending on the dosage form, route of injection (the method of administration shall not be indicated for tablets and capsules intended for oral administration); 14) precautions; 15) warning notices; 16) storage conditions, storage features and transportation conditions; 17) conditions of release (with a prescription or without a doctor’s prescription); 18) series number; 19) production date (if not entered in the batch number); 20) expiration date: “best before: (date, month, year)” or “(date, month, year)”; The expiration date is indicated as “best before (month, year)” or “(month, year)”, while the expiration date is determined up to and including the last day of the specified month; 21) registration number of the medicinal product in the form of the designation “RK-MP-”; 22) barcode (if available); 23) means of identification or a material medium containing means of identification | gross |
293. | Availability of primary package labeling indicating the following information: 1) trade name of the medicinal product, indicating the dosage, activity or concentration; 2) international nonproprietary name (if available) in the state, Russian and English languages; 3) name of the manufacturer of the medicinal product and (or) its trademark; 4) series number; 5) expiration date “month, year” or “date, month, year” Additional information shall be placed that is identical to the information printed on the secondary packaging. Intermediate packaging, which does not allow the information on the primary packaging to be read without compromising its integrity, repeats the information indicated on the primary packaging | gross |
294. | Organization of work to monitor adverse reactions and (or) lack of effectiveness of medicines and medical devices, appointment of responsible persons for monitoring side effects of medicines and medical devices | significant |
295. | Provision by the responsible person to the authorized organization of information about side effects and (or) lack of effectiveness of medicines and medical devices. Transmission of record cards through the portal of an authorized organization online containing a mandatory minimum amount of information | significant |
296. | Compliance with the deadlines for submitting a completed report card about adverse reactions (actions) and (or) effectiveness to the authorized organization in cases of detection | significant |
297. | Absence of facts of purchase, production, storage, advertising, use, provision and sale of medicines and medical devices that have not passed state registration in the Republic of Kazakhstan | gross |
298. | Absence of facts of production, import, storage, use and sale of counterfeit medicines and medical devices | gross |
299. | Absence of facts of sales of medicines and medical devices, the quality of which is not confirmed by a conclusion on safety and quality | gross |
300. | Absence of facts of storage, use and sale of expired medicines and medical devices | gross |
301. | Compliance of the medicine with the requirements of the regulatory document on control of the quality and safety of the medicine and medical device (based on the results of assessing the safety and quality of samples withdrawn as doubt) | gross |
302. | Compliance with the requirements for storage, accounting, destruction of medicines containing narcotic drugs, psychotropic substances and precursors (including substances): The destruction of narcotic drugs, psychotropic substances, their analogues and precursors can be carried out in cases where: 1) the shelf life of the narcotic drug, psychotropic substance and precursors has expired; 2) narcotic drugs, psychotropic substances, precursors have been subjected to chemical or physical influence, resulting in their unusability, excluding the possibility of their restoration or processing; 3) confiscated, discovered and withdrawn from illegal traffic of narcotic drugs, psychotropic substances, their analogs and precursors do not represent medical, scientific or other value and cannot be processed, as well as in other cases provided for by the legislation of the Republic of Kazakhstan. | gross |
303. | Availability of a list of persons who have conclusions from psychiatrists and narcologists about the absence of drug addiction, substance abuse, chronic alcoholism, as well as about suitability for carrying out activities related to narcotic drugs, psychotropic substances and their precursors and the conclusion of the internal affairs bodies to conduct the relevant inspection | gross |
304. | Storage rooms, safes and cabinets shall be kept closed. After the end of the working day, they are sealed and (or) stamped. Keys, seal and (or) stamp shall be kept by the responsible person | gross |
305. | Availability of a first aid kit | minor |
306. | Availability of a sign indicating the name of the subject of pharmaceutical activity, its organizational and legal form and mode of operation in the state and Russian languages | minor |
307. | Availability of information about the telephone numbers and addresses of territorial divisions of the state body in the field of circulation of medicines and medical devices in a place convenient for the public to familiarize | minor |
308. | Ensuring traceability of medicines marked with identification means by providing the drug administration and entities in the field of circulation of medicines and medical devices with information on the introduction into circulation, sale and (or) transfer, as well as on the withdrawal from circulation of labeled medicinal products in the territory of the Republic of Kazakhstan | gross |
309. | Compliance with the rules for advertising medicines and medical devices: 1) advertising of medicines and medical products is reliable, recognizable without special knowledge or the use of special means, exclude comparisons with other pharmaceutical services, medicines and medical devices, do not mislead consumers by abusing their trust, including with regard to characteristics, composition, consumer properties, cost (price), expected results of use, results of research and testing; 2) advertising of medicines and medical devices is provided in the Kazakh and Russian languages, contains complete and reliable information about the medicine or medical device, complies with the instructions for medical use of the medicine (insert leaflet), instructions for medical use or operational document for the medical device; 3) availability of a conclusion on the compliance of advertising of medicines and medical devices with the requirements of the legislation of the Republic of Kazakhstan in the field of healthcare | gross |
310. | Prohibition of advertising of medicines and medical devices: 1) not registered in the Republic of Kazakhstan; 2) prescription drugs in the media; 3) distribution for advertising purposes of samples of medicines released with a doctor’s prescription; 4) the use of children, their images and voices in advertising of medicines and medical devices, except for medicines and medical devices for children; 5) distribution and placement of advertising of medicines and medical devices in public transport, organizations not related to their purpose, use and release, with the exception of advertising of medicines at medical, pharmaceutical conferences, congresses, symposiums and other scientific meetings; 6) placement of advertising information on industrial products, prescription forms; 7) placement of outdoor (visual) advertising of medicines and medical devices; 8) the use of medical workers authorized to prescribe medicines and medical devices as distributors of advertising, with the exception of cases of providing reliable information about medicines and medical devices for scientific or educational purposes, as well as for the purpose of informing patients; 9) advertising of pharmaceutical services in the absence of a license to carry out the relevant type of activity; 10) advertising of pharmaceutical services provided by persons who do not have a certificate as a specialist in the field of healthcare, including foreign specialists; 11) indication in advertising for the population of methods of treatment for the following diseases: sexually transmitted diseases, cancer, mental, behavioral disorders (diseases), dangerous infectious diseases, HIV infection, tuberculosis, diabetes mellitus; 12) refer in advertising to the recommendations of scientists, healthcare professionals, as well as state officials who may encourage the use and (or) prescription of medicines and medical devices; 13) present in advertising services, medicines and medical devices, biologically active food additives as unique, the safest and most effective; 14) assert that the safety and effectiveness of the medicinal product are due to its natural origin; 15) cause assumptions that the effectiveness of the service provided, treatment with an advertised medicinal product, biologically active food supplement is guaranteed, and the use of the product is not accompanied by the development of side effects; 16) provide information in advertising that is not directly related to the advertised pharmaceutical service, medicine and medical device | gross |
311. | Availability of a document on calibration and (or) verification of a medical device that is a measuring instrument | gross |
312. | Compliance with the fact that the operated medical equipment, at the time of acceptance, was new, unused, of the latest or serial model, without defects | gross |
313. | Availability of a log of the technical condition of medical equipment subject to service | gross |
314. | Availability of documents confirming current and major repairs | significant |
315. | Availability of documents confirming warranty service (at least thirty-seven months from the date of commissioning and frequency recommended by the manufacturer) consisting of periodic monitoring of the technical condition of medical equipment (at least once a year) | gross |
316. | Availability at the operated medical equipment of: 1) operational documentation (operation manual and service manual); 2) service manual for medical equipment | gross |
317. | The presence or absence of facts of medical equipment operation that is not provided with service, removed from service, or operation of medical equipment by personnel who do not have special training, who have not been trained in the use of medical equipment | gross |
318. | The presence or absence of facts of unreasonable downtime of medical equipment (lack of measures to restore serviceable condition) | significant |
319. | Availability of a certificate of compliance with the requirements of the Good Distribution Practice (GDP) Standard | gross |
Section 5. In relation to subjects (objects) of pharmaceutical activities engaged in retail sales of medicines and medical devices | ||
320. | Ensuring the sale of medical devices related to measuring instruments, in the presence of a certificate of approval of the type of measuring instruments or a certificate of metrological certification of medical measuring equipment | gross |
321. | Ensuring the sale of prescription medicines according to a doctor’s prescription | gross |
322. | Ensuring that medicines sold without a doctor's prescription are placed on display windows | significant |
323. | Registration of invalid prescriptions in the Register of incorrectly written prescriptions and their redemption with the stamp “Prescription is invalid” | minor |
324. | Compliance with shelf life of prescriptions: 1) for a medicine containing narcotic drugs, psychotropic substances, precursors and toxic substances – 1 (one) year; 2) for medicines released within the framework of the guaranteed volume of free medical care and (or) compulsory social health insurance - 2 (two) years; 3) for other medicines - at least 30 (thirty) calendar days | significant |
325. | Ensuring that reliable information is provided regarding: 1) correct and rational application or use; 2) possible side effects and contraindications; 3) interactions with other drugs, precautions for their use or use; 4) expiration dates and storage rules; | significant |
326. | Availability of a document on calibration and (or) verification of a medical device that is a measuring instrument | gross |
327. | Compliance with the fact that the operated medical equipment, at the time of acceptance, was new, unused, of the latest or serial model, without defects | gross |
328. | Availability of a log of the technical condition of medical equipment subject to service | gross |
329. | Availability of documents confirming current and major repairs | significant |
330. | Availability of documents confirming warranty service (at least thirty-seven months from the date of commissioning and frequency recommended by the manufacturer) consisting of periodic monitoring of the technical condition of medical equipment (at least once a year) | gross |
331. | Availability at the operated medical equipment of: 1) operational documentation (operation manual and service manual); 2) service manual for medical equipment | gross |
332. | The presence or absence of facts of operation of medical equipment that is not provided with service, removed from service, or operation of medical equipment by personnel who do not have special training or have not been trained in the use of medical equipment | gross |
333. | The presence or absence of facts of unreasonable downtime of medical equipment (lack of measures to restore serviceable condition) | significant |
334. | Ensuring the implementation of preventive measures: 1) quality control during acceptance and implementation; 2) compliance with the rules and shelf life of medicines, keeping records of medicines with a limited shelf life; 3) serviceability and accuracy of weighing instruments; 4) checking the correctness of the prescribed prescription, its validity period, the compliance of the prescribed doses with the patient’s age, the compatibility of ingredients, and the norms for one-time release; 5) keeping records of the validity periods of safety and quality assessment conclusions | gross |
335. | Ensuring acceptance of medicines and medical devices with checking: 1) the compliance of the quantity, completeness, integrity of the container, compliance of packaging, labeling with regulatory documents, availability of instructions for the medical use of a medicine and medical device in the state and Russian languages; availability of an operational document for a medical device; 2) compliance with the name, dosage, packaging, quantity, batch (series) of products specified in the accompanying documents; 3) the presence in the accompanying documents of a certificate of conformity or a reference to it in the invoice for the release of goods | gross |
336. | Availability of information on the list of medicines and specialized medicinal products for free provision of certain categories of citizens with certain diseases at the outpatient level in a convenient place for familiarization | minor |
337. | Availability of lists and sample signatures of persons entitled to sign prescriptions for free receipt of medicines approved by the head of the relevant healthcare organization in retail sales facilities that have relevant agreements with local government healthcare authorities | minor |
338. | Ensuring placement in a place convenient for familiarization of: 1) a copy of the license for pharmaceutical activities and its appendices or a document (including a printed copy of an electronic document) informing about the start or termination of activities or certain actions; 2) books of reviews and suggestions; 3) information about the telephone numbers of the pharmaceutical reference service | minor |
339. | Ensuring that the following information is placed in a place visible to visitors: “Medicines cannot be returned or exchanged”; “Medicines are not given to children”; “The over-the-counter sale of medicines intended for prescription is prohibited”; “Shelf life of drugs prepared in pharmacies” | minor |
340. | Compliance with the maximum price for the trade name of a medicine during retail sales | gross |
341. | Availability of a specialist certificate in the field of healthcare for each pharmaceutical worker | gross |
342. | Availability of a state license for pharmaceutical activities and appendices for subtypes of activity or notification on the start of activity. Compliance with the types and subtypes of activities declared upon receipt of the state license and its appendix | gross |
343. | Ensuring storage and transportation in accordance with the conditions established by the manufacturer in the regulatory and technical document on monitoring the quality and safety of medicines, in the instructions for medical use for medicines and medical devices, operational documents (for medical devices), indicated in the labeling of their packages | gross |
344. | Ensuring the safety, storage conditions of various groups of medicines and medical devices and their handling by complying with the requirements for the design, arrangement, composition, size of areas, equipment of premises (zones) for storing medicines and medical devices and their operation, ensuring safety | gross |
345. | Observance of separate storage of medicines and medical devices from other products in order to avoid any impact on them, protection from the negative effects of light, temperature, moisture and other external factors | gross |
346. | Keeping records of the expiration dates of medicines and medical devices on paper or electronic media | minor |
347. | Carrying out the storage of medicines and medical devices in designated and clearly marked storage zones | significant |
348. | Providing the storage room, including the refrigeration room (chamber), with appropriate equipment for monitoring temperature, air humidity (thermometers, hygrometers, other types of instruments) and their location on the internal walls of the premises away from heating devices based on the results of testing zones of temperature fluctuations for cold and warm season | gross |
349. | Compliance with separation during storage of all medicines and medical devices depending on the pharmacological group, method of administration, physical state, physicochemical properties, exposure to various environmental factors | gross |
350. | Availability of an isolated place for storing medicines, the decision on the circulation of which has not yet been made, expired, returned, withdrawn from the category suitable for supply, for which there are suspicions of falsification, recalled and rejected | gross |
351. | Providing protection from the effects of weather conditions in the zones of acceptance and shipment. Availability of equipment in the zones of acceptance and shipment (ventilation/ air conditioning system, hygrometer, thermometer), equipment for cleaning containers. Availability of an equipped control zone for the received products | gross |
352. | Separation of acceptance, quarantine, defective, shipping and storage zones. Availability of a room in which medicines are stored in quarantine, clearly marked and with limited access | gross |
353. | Availability of common fireproof buildings with insulation by fireproof walls from neighboring premises that meet fire safety requirements in the absence of separate storage facilities for flammable substances, providing the premises with supply and exhaust ventilation | gross |
354. | Storage of flammable medicines separately from other medicines: provision of fireproof and stable racks and pallets, storage of flammable and combustible liquids in built-in fireproof cabinets with doors at least 0.7 meters wide and at least 1.2 meters high | gross |
355. | Storage of flammable liquids isolated in separate rooms in glass or metal containers from other groups | gross |
356. | Compliance with the storage of flammable and combustible liquid medicines that should not be stored: 1) in a completely filled container, the degree of filling is not more than 90 percent of the volume. Alcohols in large quantities shall be stored in metal containers, which are filled to no more than 95 percent of the volume; 2) with mineral acids (sulfuric, nitric and other acids), compressed and liquefied gases, flammable substances, as well as with inorganic salts that produce explosive mixtures with organic substances (potassium chlorate, potassium permanganate) | gross |
357. | Compliance with isolated storage of calcium hypochloride, taking into account its properties | gross |
358. | Compliance with the storage of flammable liquids with constant monitoring the condition of containers, their tightness and serviceability | gross |
359. | Implementation of measures during storage of explosive drugs against contamination by dust | gross |
360. | Compliance with separate storage of explosive and flammable medicines containing acids and alkalis | gross |
361. | Ensuring the protection of cylinders with oxygen and flammable gases from heat sources, contact with oil and other fatty substances, and their storage in isolated rooms or under canopies | gross |
362. | Compliance with the conditions for storing dressings in a dry, ventilated area in cabinets, drawers, on racks, pallets, shelves, in conditions that ensure cleanliness | gross |
363. | Compliance with the storage conditions of medical instruments, devices, instruments, equipment in dry heated rooms at room temperature, with a relative air humidity not exceeding 65 percent | gross |
364. | Compliance with the requirements for finishing premises (areas) for storing medicines and ensuring the cleanliness of premises and storage equipment | significant |
365. | Ensuring protection from insects, rodents or other animals and availability of a preventive pest control program | minor |
366. | Separation of rest rooms, dressing rooms, showers and toilets for workers from storage rooms (areas). Food products, drinks, tobacco products, and medicines for personal use shall not be stored in storage rooms (areas). Availability of protective clothing or uniform appropriate for the work performed and personal protective equipment if necessary for employees working in the storage area. Personnel working with dangerous drugs shall undergo special training | significant |
367. | Providing with the necessary equipment and inventory in drug storage premises: 1) racks, pallets, shelves, cabinets for storing medicines and medical devices; 2) technological equipment for creating temperature conditions; 3) instruments for recording temperature and humidity; 4) means of mechanization for loading and unloading operations; 5) disinfectants and cleaning equipment to ensure sanitary conditions; 6) other equipment and inventory ensuring sanitary and hygienic conditions, labor protection, safety precautions, fire safety, environmental protection and safety of medicines | gross |
368. | Availability of a document on calibration (verification) of equipment used to control and monitor storage conditions | gross |
369. | Availability of a developed and approved emergency action plan in case of malfunction of the refrigeration room (chamber), refrigeration equipment or power outage, emergency situations | significant |
370. | Availability of developed and approved instructions for cleaning and disinfection of equipment. The equipment shall be used in good condition and kept in proper cleanliness | significant |
371. | Availability of a person responsible for ensuring the safety of the quality of medicines and medical devices at facilities carrying out the storage of medicines and medical devices | significant |
372. | Presence of a commission for the destruction of medicines and medical devices unsuitable for sale and medical use | significant |
373. | Availability of acts on the destruction of medicines and medical devices unsuitable for sale and medical use | significant |
374. | Availability of secondary package labeling, including the following information: 1) trade name of the medicine; 2) international nonproprietary name (if available) in Kazakh, Russian and English; 3) name of the manufacturer of the medicine, address. The name of the manufacturer and its address shall be indicated in full or abbreviated (city, country). A trademark shall be indicated when it is granted legal protection in the Republic of Kazakhstan. If the manufacturer of the medicine is not its packager, then the name of the packager, date and time of packaging shall be indicated; 4) name of the holder of the registration certificate, his address (city, country); 5) dosage form; 6) dosage, and (or) activity, and (or) concentration (if applicable) of the active pharmaceutical substance (active pharmaceutical substances); 7) the amount of the medicinal product in the package by weight, volume or number of dosage units, depending on the dosage form and type of packaging; 8) information on the composition of the medicinal product; 9) for medicinal herbal preparations, which are packaged medicinal plant raw materials, the mass of medicinal plant raw materials and (or) active pharmaceutical substance of plant origin shall be indicated at their certain humidity; 10) for medicinal products containing narcotic substances, psychotropic substances, their analogs and precursors, the names of these substances and their content in weight units or percentages shall be indicated. In single-component medicinal products, subject to the authenticity of the name of the medicinal product and the active pharmaceutical substance and indication of its dosage, concentration, activity, the composition of the active pharmaceutical substance shall not be indicated; 11) list of excipients: for parenteral, ophthalmic drugs and drugs for external use, a list of all excipients shall be indicated; for infusion solutions, the qualitative and quantitative composition of all excipients shall be indicated; for other dosage forms, a list of antimicrobial preservatives, dyes, as well as sugars and ethanol shall be indicated; 12) for infusion solutions that contain more than one active pharmaceutical substance, the value of osmolarity and (or) osmolality shall be indicated; 13) method of administration and, depending on the dosage form, route of injection (the method of administration shall not be indicated for tablets and capsules intended for oral administration); 14) precautions; 15) warning notices; 16) storage conditions, storage features and transportation conditions; 17) conditions of release (with a prescription or without a doctor’s prescription); 18) series number; 19) production date (if not entered in the batch number); 20) expiration date: “best before: (date, month, year)” or “(date, month, year)”; The expiration date shall be indicated as “best before (month, year)” or “(month, year)”, while the expiration date shall be determined up to and including the last day of the specified month; 21) registration number of the medicinal product in the form of the designation “RK-MP-”; 22) barcode (if available); 23) means of identification or a material medium containing means of identification | gross |
375. | Availability of primary package labeling indicating the following information: 1) trade name of the medicinal product, indicating the dosage, activity or concentration; 2) international nonproprietary name (if available) in the state, Russian and English languages; 3) the name of the manufacturer of the medicinal product and (or) its trademark; 4) series number; 5) expiration date “month, year” or “date, month, year” Additional information shall be placed that is identical to the information printed on the secondary packaging. Intermediate packaging, which does not allow the information on the primary packaging to be read without compromising its integrity, repeats the information indicated on the primary packaging | gross |
376. | Organization of work to monitor adverse reactions and (or) lack of effectiveness of medicines and medical devices, appointment of responsible persons for monitoring side effects of medicines and medical devices | significant |
377. | Provision by the responsible person to the authorized organization of information about side effects and (or) lack of effectiveness of medicines and medical devices. Transmission of report cards through the portal of an authorized organization online containing a mandatory minimum amount of information | significant |
378. | Compliance with the deadlines for submitting a completed report card about adverse reactions (actions) and (or) effectiveness to the authorized organization in cases of detection | significant |
379. | Absence of facts of purchase, production, storage, advertising, use, provision and sale of medicines and medical devices that have not passed state registration in the Republic of Kazakhstan | gross |
380. | Absence of facts of production, import, storage, use and sale of counterfeit medicines and medical devices | gross |
381. | Absence of facts of sales of medicines and medical devices, the quality of which is not confirmed by a conclusion on safety and quality | gross |
382. | Absence of facts of storage, use and sale of expired medicines and medical devices | gross |
383. | Compliance of the medicine with the requirements of the regulatory document on control of the quality and safety of the medicine and medical device (based on the results of assessing the safety and quality of samples withdrawn as doubt) | gross |
384. | Compliance with the requirements for storage, accounting, destruction of medicines containing narcotic drugs, psychotropic substances and precursors (including substances): The destruction of narcotic drugs, psychotropic substances, their analogues and precursors can be carried out in cases when: 1) the shelf life of the narcotic drug, psychotropic substance and precursors has expired; 2) narcotic drugs, psychotropic substances, precursors have been subjected to chemical or physical influence, resulting in their unusability, excluding the possibility of their restoration or processing; 3) confiscated, discovered and withdrawn from illegal traffic of narcotic drugs, psychotropic substances, their analogs and precursors do not represent medical, scientific or other value and cannot be processed, as well as in other cases provided for by the legislation of the Republic of Kazakhstan. | gross |
385. | Availability of a list of persons who have conclusions from psychiatrists and narcologists about the absence of drug addiction, substance abuse, chronic alcoholism, as well as about suitability for carrying out activities related to narcotic drugs, psychotropic substances and their precursors and the conclusion of the internal affairs bodies to conduct the relevant inspection | gross |
386. | Storage rooms, safes and cabinets shall be kept closed. After the end of the working day, they are sealed and (or) stamped. Keys, seal and (or) stamp shall be kept by the responsible person | gross |
387. | Availability of a first aid kit | minor |
388. | Availability of a sign indicating the name of the subject of pharmaceutical activity, its organizational and legal form and mode of operation in the state and Russian languages | minor |
389. | Availability of information about the telephone numbers and addresses of territorial divisions of the state body in the field of circulation of medicines and medical devices in a place convenient for the public to familiarize | minor |
390. | Ensuring traceability of medicines marked with identification means by providing the drug administration and entities in the field of circulation of medicines and medical devices with information on the introduction into circulation, sale and (or) transfer, as well as on the withdrawal from circulation of labeled medicines in the territory of the Republic of Kazakhstan | gross |
391. | Compliance with the rules for advertising medicines and medical devices: 1) advertising of medicines and medical products is reliable, recognizable without special knowledge or the use of special means, exclude comparisons with other pharmaceutical services, medicines and medical devices, do not mislead consumers by abusing their trust, including with regard to characteristics, composition, consumer properties, cost (price), expected results of use, results of researches and testings; 2) advertising of medicines and medical devices is provided in the Kazakh and Russian languages, contains complete and reliable information about the medicine or medical device, complies with the instructions for medical use of the medicine (insert leaflet), instructions for medical use or operational document for the medical device; 3) availability of a conclusion on the compliance of advertising of medicines and medical devices with the requirements of the legislation of the Republic of Kazakhstan in the field of healthcare | gross |
392. | Prohibition of advertising of medicines and medical devices: 1) not registered in the Republic of Kazakhstan; 2) prescription drugs in the media; 3) distribution for advertising purposes of samples of medicines released with a doctor’s prescription; 4) the use of children, their images and voices in advertising of medicines and medical devices, except for medicines and medical devices for children; 5) distribution and placement of advertising of medicines and medical devices in public transport, organizations not related to their purpose, use and release, with the exception of advertising of medicines at medical, pharmaceutical conferences, congresses, symposiums and other scientific meetings; 6) placement of advertising information on industrial products, prescription forms; 7) placement of outdoor (visual) advertising of medicines and medical devices; 8) the use of medical workers authorized to prescribe medicines and medical devices as distributors of advertising, with the exception of cases of providing reliable information about medicines and medical devices for scientific or educational purposes, as well as for the purpose of informing patients; 9) advertising of pharmaceutical services in the absence of a license to carry out the relevant type of activity; 10) advertising of pharmaceutical services provided by persons who do not have a certificate as a specialist in the field of healthcare, including foreign specialists; 11) indication in advertising for the population of methods of treatment for the following diseases: sexually transmitted diseases, cancer, mental, behavioral disorders (diseases), dangerous infectious diseases, HIV infection, tuberculosis, diabetes mellitus; 12) refer in advertising to the recommendations of scientists, healthcare professionals, as well as government officials who may encourage the use and (or) prescription of medicines and medical devices; 13) present in advertising services, medicines and medical devices, biologically active food additives as unique, the safest and most effective; 14) assert that the safety and effectiveness of the medicinal product are due to its natural origin; 15) cause assumptions that the effectiveness of the service provided, treatment with an advertised medicinal product, biologically active food supplement is guaranteed, and the use of the product is not accompanied by the development of side effects; 16) provide information in advertising that is not directly related to the advertised pharmaceutical service, medicine and medical device | gross |
Section 6. In relation to the state expert organization in the field of circulation of medicines and medical devices | ||
393. | Violation of the rules of state registration, re-registration of a medicine or medical device, amendments to the registration dossier of a medicine or medical device by the State expert organization in the field of circulation of medicines and medical devices | gross |
394. | Violation of the procedure for conducting an examination of medicines conducted by a state expert organization in the field of circulation of medicines and medical devices when conducting an examination of the quality and safety of vaccines | gross |
Section 7. According to the sources of information provided for in subparagraphs 2) -7) of paragraph 14 of the Criteria | ||
Criteria for the source of information “Analysis of official Internet resources of state bodies, including authorized bodies in the field of healthcare of countries of the Commonwealth of Independent States (CIS), and the media” | ||
1. | Availability of facts of non-compliance of medicines and medical devices with the requirements of the legislation of the Republic of Kazakhstan on the safety, effectiveness and quality of medicines and medical devices, identified based on the results of the analysis of official media, information on helplines, hotlines, information provided by state bodies and organizations, including international ones, as well as websites of authorized bodies in the field of healthcare of countries of the Commonwealth of Independent States (CIS) | gross |
Criteria for the source of information “List of identified violations based on the results of laboratory tests conducted by the state expert organization in the field of circulation of medicines and medical devices” | ||
2. | Availability of test results presented by the state expert organization in the field of circulation of medicines and medical devices, confirming non-compliance with the safety, effectiveness and quality of medicines and medical devices | gross |
Criteria for the source of information “The presence of adverse incidents that arose through the fault of the subject of control. Adverse incidents include the probability of causing harm to health, a threat to human life or health, as a result of the production, manufacture, import, storage, sale, application (use) of medicines and medical devices, including those that do not comply with the requirements of the legislation of the Republic of Kazakhstan in the field of healthcare” | ||
3. | The presence of adverse events that have led to a threat to human life or health, caused by the fault of the subject of pharmaceutical activity | gross |
Criteria for the source of information “Information from international regulatory authorities in the field of quality and safety of medicines and medical devices, state bodies of countries, including the Eurasian Economic Union” | ||
4. | Information from international bodies, state bodies of countries, including the Eurasian Economic Union, on facts of non-compliance of medicines and medical devices with legal requirements for safety, effectiveness and quality | gross |
Appendix 3
to the criteria for assessment
the degree of risk
in the area of circulation
medicines and medical devices
List of subjective criteria for determining the degree of risk according to subjective criteria in the field of circulation of medicines and medical devices in accordance with Article 138 of the Entrepreneurial Code of the Republic of Kazakhstan in relation to all subjects (objects)
№ | Indicator of the subjective criterion | Source of data for the indicator of subjective criterion | Specific weight by significance, points (the total should be 100) | Condition | ||
condition 1/value | condition 2/value | |||||
For preventive control with a visit | ||||||
1. | The presence of a negative analysis result or non-conformity of medicines and medical devices identified within the framework of the Rules for assessing the quality of medicines and medical devices registered in the Republic of Kazakhstan, approved by order of the Minister of Healthcare of the Republic of Kazakhstan dated 20.12.2020 № KR HCM-282/2020, the Rules for selection from the market, including in medical organizations, medicines and medical devices subject to quality control taking into account a risk-based approach, approved by the order of the acting Minister of Healthcare of the Republic of Kazakhstan dated 24.12.2020 № KR HCM-323/2020 | results of the information analysis provided by state bodies and organizations, non-conformity, absence and (or) presence of a negative conclusion obtained based on the results of assessing the quality of medicines and medical devices registered in the Republic of Kazakhstan, as well as non-conformity, absence and (or) presence of a negative conclusion obtained by the results of selection from the market, including in medical organizations, of medicines and medical devices subject to quality control taking into account a risk-based approach. | high risk | no negative result | presence of a negative result | |
0% | 100% | |||||
For the checks for compliance with requirements | ||||||
1. | The fact that there is no re-issuance of the license and (or) an appendix to the license of an individual entrepreneur: 1) changes in the surname, name, patronymic (if any) of the individual licensee; 2) re-registration of an individual entrepreneur-licensee, changing his name or legal address; 3) reorganization of the legal entity-licensee in accordance with the procedure determined by Article 34 of the Law of the Republic of Kazakhstan “On Permits and Notifications” (hereinafter - the Law); 4) changing the address of the object location without physically moving it for a license issued under the class “permits issued for objects” or for appendices to a license indicating objects; 5) availability of a requirement for re-registration in the laws of the Republic of Kazakhstan | clause 11.8. results of information analysis provided by state bodies and organizations | high risk | yes | no | |
0% | 100% | |||||
2. | The fact that there is no re-issuance of the license and (or) an appendix to the license of a legal entity: 1) changes in the surname, name, patronymic (if any) of the individual licensee; 2) re-registration of an individual entrepreneur-licensee, changing his name or legal address; 3) reorganization of the legal entity-licensee in accordance with the procedure determined by Article 34 of the Law; 4) changing the address of the object location without physically moving it for a license issued under the class “permits issued for objects” or for appendices to a license indicating objects; 5) availability of a requirement for re-registration in the laws of the Republic of Kazakhstan | clause 11.8. results of information analysis provided by state bodies and organizations | high risk | yes | no | |
0% | 100% | |||||
Appendix 16
to the joint order
of the Minister of Healthcare
of the Republic of Kazakhstan
dated November 15, 2018
№ KR HCM-32 and
the Minister of National
economy of the Republic of Kazakhstan
dated November 15, 2018 № 70
Checklist in the field of circulation of medicines and medical devices for compliance with qualification requirements for subjects (objects) of control
Footnote. Appendix 16 is in the wording of the joint order of the acting Minister of Healthcare of the Republic of Kazakhstan dated 24.05.2023 № 87 and the Minister of National Economy of the Republic of Kazakhstan dated 24.05.2023 № 77 (shall be enforced upon expiry of ten calendar days after the day of its first official publication).
The state body that appointed an inspection/preventive control with a visit
to the subject (object) of control
_______________________________________________________
__________________________________________________________________________
An act on the appointment of an inspection/preventive control with a visit to the subject
(object) of control
_______________________________________________________________________
__________________________________________________________________________
№, date
Name of the subject (object) of control
__________________________________________________________________________
(Individual identification number), the business identification number of the subject (object)
of control
______________________________________________________________
Location address
__________________________________________________________________________
№ | List of requirements | Meets the requirements | Does not meet the requirements |
1. | Compliance of a premise or building under the right of ownership or lease or trust management of state property with sanitary rules establishing sanitary and epidemiological requirements for facilities in the field of circulation of medicines and medical devices | ||
2. | Availability of equipment and furniture, inventory, instruments and apparatus to ensure quality control and compliance with the conditions of production, manufacturing, storage and sale of medicines and medical devices in accordance with regulatory legal acts | ||
3. | Availability of a motor vehicle with appropriate cabinets and refrigeration and other equipment, if necessary, ensuring compliance with the conditions of storage and sale of medicines and medical devices for a mobile pharmacy for rural settlements | ||
4. |
Availability of a staff of employees with appropriate education, work experience and specialist certificates for organizations producing medicines and medical devices: | ||
5. |
Availability of a staff of employees with appropriate education, work experience and a specialist certificate for organizations in the field of circulation of medicines and medical devices engaged in the manufacture of medicines: | ||
6. |
Availability of a staff of employees with appropriate education, work experience and a specialist certificate for pharmacies: | ||
7. |
Availability of a staff of employees with appropriate education, work experience and a specialist certificate for a pharmacy in healthcare organizations providing primary health care, consultative and diagnostic care: | ||
8. |
Availability of a staff of employees with appropriate education, work experience and a specialist certificate for a pharmacy warehouse: | ||
9. |
Availability of a staff of employees with appropriate education, work experience and a specialist certificate for a mobile pharmacy for rural settlements: | ||
10. |
Availability of a staff of employees with appropriate education, work experience and a specialist certificate for the manufacture of medical devices: | ||
11. | Availability of specialization or improvement and other types of advanced training over the last 5 (five) years in the declared subtypes of pharmaceutical activities | ||
12. | Availability of higher or secondary pharmaceutical education (work experience in the specialty - at least three years) for individuals applying to engage in pharmaceutical activities without forming a legal entity |
Official(s)
__________________________________________________________________________
position signature
__________________________________________________________________________
surname, name, patronymic (if any)
Head of the subject of control
__________________________________________________________________________
position signature
__________________________________________________________________________
surname, name, patronymic (if any)
| Appendix 17 to the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated November 15, 2018 №ҚР ДСМ-32 and the Minister of National Economy of the Republic of Kazakhstan dated November 15, 2018 №70 |
Checklist in the field of circulation of medicines and medical devices in relation to medical organizations on drug supply issues
Footnote. Appendix 17 – as amended by the joint order of the Acting Minister of Healthcare of the Republic of Kazakhstan dated 24.05.2023 №87 and the Minister of National Economy of the Republic of Kazakhstan dated 24.05.2023 № 77 (effective ten calendar days after the date of its first official publication).
State body that appointed inspection/preventive control with a visit to the
control subject (object) _______________________________________________________
__________________________________________________________________________
Act on appointing inspection / preventive control with a visit to the
control subject (object)
_____________________________________________________________
__________________________________________________________________________
№, date
Name of the control subject (object)
__________________________________________________________________________
(Individual Identification Number), Business Identification Number of the
control subject (object)
_______________________________________________________________
Location address
№ | List of requirements | Compliance with requirements | Non-compliance with requirements |
1. | Compliance with the prescription of medicines containing narcotic drugs, psychotropic substances and their precursors during outpatient and inpatient treatment in health care organizations by a doctor of a health care organization who has access to work with narcotic drugs and their precursors | ||
2. | Compliance with the recording in the patient’s medical documents of the prescription of medications containing narcotic drugs, psychotropic substances and precursors in accordance with Tables II, III, IV of the List of narcotic drugs, psychotropic substances and precursors subject to control in the Republic of Kazakhstan, indicating the single dose, method and frequency of administration, duration of treatment, also substantiation of prescribing the medications | ||
3. | Ensuring the use (taking) of medicines containing narcotic drugs, psychotropic substances of Tables II, III of the List strictly under the supervision of medical personnel at the time of their dispensing - oral administration, application of transdermal therapeutic systems (patch, film) - in the presence of a nurse, administration of injections - in the presence of a doctor | ||
4. | Compliance with the rules and procedures for writing prescriptions for medicines containing narcotic drugs, psychotropic substances and precursors (hereinafter -NPP Rules) | ||
5. | Presence of a person responsible for storage and issuance of special prescription forms | ||
6. | Ensuring subject-quantitative accounting of special prescription forms | ||
7. | Availability of a safe or metal cabinet for storing special prescription forms. At the end of the work, the room shall be sealed and (or) stamped. The keys to the room, the seal and (or) the sealer shall be kept by the person in charge | ||
8. | Ensuring storage and destruction of unused special prescriptions handed in by relatives of deceased patients. Destruction of prescriptions shall be carried out as prescriptions accumulate, but at least once a month, by burning in the presence of a permanent commission, which shall include a representative of the internal affairs body. The fact of destruction of unused special prescriptions shall be formalized by an appropriate report | ||
9. | Availability of the list of medicines containing narcotic drugs, psychotropic substances of Table II of the List, determined by the order of the head of the healthcare organization, not exceeding a five-day supply, which is used with the permission of the responsible doctor on duty, to provide emergency medical care in a healthcare organization providing inpatient care in the evening and nighttime. | ||
10. | Ensuring collection and destruction of empty ampoules from medicines containing narcotic drugs, psychotropic substances of Table II of the List, the contents of which are unused or partially used, as well as tablets and patches (transdermal therapeutic systems) | ||
11. | Availability of an order for a medical worker responsible for issuing a temporary death certificate, ensuring notification of relatives of a deceased cancer patient about handing over unused special prescription forms and medicines containing narcotic and psychotropic substances of Table II of List, as well as acceptance of special prescription forms and unused medicines, containing narcotic and psychotropic substances of Table II of the List after patients died at home. Availability of acts of acceptance and transfer of medicines containing narcotic drugs, psychotropic substances and their precursors remaining after the death of the patient | ||
12. | Presence of a permanent commission, which includes representatives of internal affairs bodies and the territorial division of the state body in the field of sanitary and epidemiological welfare of the population for destruction of medicines containing narcotic drugs, psychotropic substances of Table II List with expired dates, handed over by relatives of deceased patients, and also broken, defective, empty ampoules, tablets and patches (transdermal therapeutic systems), also ampoules, tablets and patches (transdermal therapeutic systems), the contents of which have been partially used | ||
13. | Availability of acts of destruction of medicines containing narcotic drugs, psychotropic substances and their precursors of Tables II, III, IV of List | ||
14. | Compliance with the rules and procedures for registration and storage of medical documentation, requirements for medicines containing narcotic drugs, psychotropic substances and precursors of Tables II, III, IV of the List, approved by the NPP Rules | ||
15. | Compliance with prescription regulations | ||
16. | Ensuring registration and monitoring of prescriptions for free or discounted medications | ||
17. | Ensuring that the specimen signatures of authorized persons entitled to sign prescriptions are sent to the facilities of the pharmaceutical organization | ||
18. | Reflection in the patient’s outpatient record of the contents and numbers of prescriptions for free or discounted medications | ||
19. |
Ensuring the calculation of the need for medicines: | ||
20. | Compliance with the conditions for the procurement of medicines and pharmaceutical services within the framework of the guaranteed volume of free medical care (hereinafter - GVFMC) and medical care in the system of compulsory social health insurance (hereinafter - CSHI) | ||
21. | Ensuring the distribution of medicines depending on the projected number of patients and certain categories of citizens living in populated areas, by type of diseases | ||
22. |
The following information for patients shall be placed in medical organizations providing outpatient and polyclinic care, facilities in the sphere of drug circulation that provide pharmaceutical services within the framework of the SGBMP, as well as in periodic printed publications distributed on the territory of the respective administrative-territorial unit: | ||
23. | Compliance with the rational use (prescription) of medicines and the formation of a drug formulary based on proven clinical effectiveness and safety of medicines | ||
24. | Presence of a permanent commission that, at least once a quarter, analyzes medical prescriptions at the inpatient, hospital-replacement and outpatient levels | ||
25. | Ensuring the accounting of medicines within the GVFMC framework during the provision of inpatient, hospital-replacement and outpatient care within the GVFMC framework in total and quantitative terms in medical records or automated programs for accounting and use of medicines | ||
26. | Reflection of used medications in the medical record of an inpatient patient, in the list of medical prescriptions | ||
27. | Ensuring provision of medicines received for emergency, inpatient and hospital substitution care within the GVFMC framework with a stamp of a medical organization indicating the name of the medical organization, its address and “Free of charge” mark | ||
28. | Entering information about side effects, serious side effects and lack of efficacy in the medical record of an inpatient and (or) outpatient patient, including statistics on identified cases of side effects in the medical organization | ||
29. | Compliance with the requirements for separate storage and accounting of medicines and medical devices procured for the provision of medical care within the GVFMC framework, additional medical care to persons held in pre-trial detention centers and penal (penitentiary) institutions at the expense of budget funds and (or) in the CSHI system and paid services | ||
30. | Compliance with maximum prices for the trade name of medicines and medical devices, for the international nonproprietary name of a medicine or the technical characteristics of a medical product within the GVFMC framework and (or) in the CSHI system | ||
31. | In medical organizations providing medical care at all levels within the GVFMC framework, additional medical care to persons held in pre-trial detention facilities and penal (penitentiary) institutions, at the expense of budgetary funds and (or) in the CSHI system, a stock of medicines and medical devices shall be created: for at least one month, except for medical care for HIV infection, where the stock of medicines and medical devices is created for at least three months | ||
32. | Provision with medicines, medical devices, specialized therapeutic products, immune-biological medicines within the GVFMC framework and (or) in the CSHI system when providing primary medical and sanitary and specialized medical care in outpatient conditions shall be carried out according to the list of medicines and medical devices for free and (or) preferential outpatient provision of certain categories of citizens of the Republic of Kazakhstan. | ||
33. | Provision with medicines and medical devices in outpatient conditions within the GVFMC framework and (or) in the CSHI system of citizens, Kandas, refugees, foreigners and stateless persons permanently residing in the territory of the Republic of Kazakhstan and serving a sentence under a court verdict in liberty deprivation places, detained, imprisoned and placed in special institutions, who are on dispensary registration, shall be carried out at the place of attachment to medical organizations. | ||
34. | Certain categories of citizens with certain diseases (conditions) shall be provided with free and (or) discounted medicines and medical devices in outpatient conditions within the GVFMC framework and (or) in the CSHI system free of charge according to a doctor's prescription | ||
35. | Mother and child first aid kits shall be issued for newborns upon discharge from obstetric organizations with a note of issuance in the development history of the newborn | ||
36. |
Compliance with the procedure for forming the need for medicines and medical devices within the GVFMC framework and the CSHI system: | ||
37. | Ensuring availability in medical organizations providing medical care at all levels within the GVFMC framework, of an additional volume of medical care for persons held in pre-trial detention centers and penal (penitentiary )institutions, at the expense of budgetary funds and (or) in the CSHI system, a supply of medicines and medical products: for at least one month, with the exception of providing medical care for HIV infection, where the stock of medicines and medical products is created for at least three months | ||
38. | Ensuring redistribution of medicines and medical devices between medical organizations independently in cases of changes in the dynamics of morbidity, transfer or relocation of a patient, changes in the treatment regimen due to intolerance, drug resistance, death, liquidation of medical organizations, changes in the profile of medical services at all levels of medical care | ||
39. | Compliance with the calculation of the forecast need for medicines for the provision of medical care in inpatient and hospital-replacement conditions | ||
40. |
Observance of ethics conditions of promoting medicinal products and medical devices specifically: | ||
41. |
Preventing breaching of ethics in the promotion of medicines and medical devices in the interaction of entities in the field of circulation of medicines and medical devices: | ||
42. | Placement in places of visual information for patients and on the Internet resource of a medical organization of the list of medicines and medical devices for free and (or) preferential outpatient provision of certain categories of citizens of the Republic of Kazakhstan with certain diseases (conditions), as well as addresses of medical organizations through which outpatient drug provision is carried out and toll-free telephone number (if available) to obtain information on the use of medicines | ||
43. | Compliance with the two-year storage period of prescriptions for medicines dispensed under the GVFMC and (or) the CSHI system | ||
44. | Holding by each pharmacy worker of a health specialist certificate | ||
45. | Availability of a state license for pharmaceutical activities and of attachments for subtypes of activity or notification of the commencement of activity. Compliance with the types and subtypes of activities declared upon receipt of the state license and attachment to it | ||
46. | Ensuring storage and transportation in accordance with the conditions established by the manufacturer in the regulatory and technical document on monitoring the quality and safety of medicines, in the instructions for medical use for medicines and medical devices, operational documents (for the medical device), indicated in the labeling of their packages | ||
47. | Ensuring safety, storage conditions and handling of various groups of medicines and medical devices by complying with the requirements for design, arrangement, composition, size of areas, equipment of premises (areas) for storage of medicines and medical devices and their operation, ensuring the safety | ||
48. | Storage of medicines and medical devices separate from other products to avoid any impact on them, protection from negative impact of light, temperature, moisture and other external factors | ||
49. | Keeping records of the expiry dates of medicines and medical devices on paper or electronic media | ||
50. | Storage of medicines and medical devices in designated and clearly marked storage areas | ||
51. | Provision of storage premises, including a refrigerating room (chamber) with appropriate equipment for control of temperature, air humidity (thermometers, hygrometers, other types of devices) and their location on the internal walls of the premises away from heating devices based on the results of testing of temperature fluctuation zones for cold and warm seasons | ||
52. | Observance of separation during storage of all medicines and medical devices depending on the pharmacological group, method of administration, aggregate state, physicochemical properties, exposure to various environmental factors | ||
53. | Availability of isolated storage space for pending, expired, returned, withdrawn, presumably counterfeit, recalled and rejected medicinal products | ||
54. | Provision of weather protection in the receiving and discharge areas. Availability of equipment in receiving and discharge areas (ventilation/air conditioning system, hygrometer, thermometer), container cleaning equipment. Availability of an equipped area for inspection of received products | ||
55. | Separation of receiving, quarantine, defective, discharge and storage areas. Availability of a clearly labeled and restricted access quarantine room where medicines are stored. | ||
56. | Availability of common non-combustible buildings with insulation by non-combustible walls from neighboring premises that meet fire safety requirements in the absence of separate storage facilities for flammable substances, provision of premises with supply and exhaust ventilation | ||
57. | Storage of flammable medicines separately from other medicines: provision of fireproof and stable racks and pallets, storage of flammable and combustible liquids in built-in fireproof cabinets with doors at least 0.7 meters wide and 1.2 meters high | ||
58. | Storage of flammable liquids isolated in separate rooms in glass or metal containers from other groups | ||
59. |
Compliance with the storage of flammable and combustible liquid medicines that should not be stored: | ||
60. | Compliance with isolated storage of calcium hypochloride, taking into account its properties | ||
61. | Compliance with the storage of flammable liquids with constant monitoring of the condition of containers, their tightness and serviceability | ||
62. | Implementation of measures in the storage of explosive medicines against contamination by dust | ||
63. | Compliance with separate storage of explosive and flammable medicines containing acids and alkalis | ||
64. | Ensuring protection of cylinders with oxygen and flammable gases from heat sources, contact with oil and other greasy substances, and their storage in isolated rooms or under sheds | ||
65. | Observance of conditions of storage of dressings in a dry ventilated area in cabinets, drawers, on racks, pallets, trays, in conditions ensuring cleanliness | ||
66. | Compliance with the conditions of storage of medical instruments, devices, appliances, equipment in dry heated rooms at room temperature, with relative humidity not exceeding 65 percent | ||
67. | Compliance with the requirements for interior finishing of premises (areas) for storing medicines and ensuring cleanliness of storage premises and equipment | ||
68. | Providing protection against the entry of insects, rodents or other animals, and presence of preventive pest control program | ||
69. |
Separation of rest rooms, dressing rooms, showers and toilets for employees from storage rooms (areas). Food, beverages, tobacco products, as well as medicines for personal use shall not be stored in storage rooms (areas). | ||
70. |
Provision of the necessary equipment and inventory in drug storage areas: | ||
71. | Availability of a document on calibration (verification) of equipment used for control and monitoring of storage conditions | ||
72. | Availability of a developed and approved emergency plan in case of malfunction of the refrigeration room (chamber), refrigeration equipment or power outage, emergency situations | ||
73. | Availability of developed and approved instructions for cleaning and disinfection of equipment. The used equipment shall be in good condition and kept in proper cleanliness | ||
74. | Availability of a person responsible for ensuring the safety of the quality of medicines and medical devices at facilities storing medicines and medical devices | ||
75. | Availability of a commission for the destruction of medicines and medical devices unsuitable for sale and medical use | ||
76. | Availability of acts on the destruction of medicines and medical devices unsuitable for sale and medical use | ||
77. |
Availability of secondary package labeling including the following information: | ||
78. |
Availability of primary packaging labeling indicating the following information: | ||
79. | Organization of work to monitor adverse reactions and (or) lack of efficacy of medicines and medical devices, appointment of responsible persons for monitoring side effects of medicines and medical devices | ||
80. | Provision by the responsible person to the authorized organization of information about side effects and (or) lack of efficacy of medicines and medical devices. Transmission of message cards through the portal of an authorized organization online containing a mandatory minimum amount of information | ||
81. | Compliance with the deadlines for submitting a completed report card about adverse reactions (actions) and (or) effectiveness to the authorized organization in cases of detection | ||
82. | Absence of facts of procurement, production, storage, advertising, use, provision and sale of medicines and medical devices that have not passed state registration in the Republic of Kazakhstan | ||
83. | Absence of facts of production, importation, storage, use and sale of counterfeit medicines and medical devices | ||
84. | Absence of facts of sale of medicines and medical devices, the quality of which is not confirmed by the conclusion on safety and quality | ||
85. | Absence of facts of storage, use and sale of expired medicines and medical devices | ||
86. | Compliance of the medicinal product with the requirements of the regulatory document on quality and safety control of the medicinal product and medical device (based on the results of safety and quality assessment of samples withdrawn as doubtful) | ||
87. |
Compliance with the requirements for storage, accounting, destruction of medicines containing narcotic drugs, psychotropic substances and precursors (including substances): | ||
88. | Availability of the list of persons who have conclusions from psychiatrists and narcologists on the absence of drug addiction, substance abuse, chronic alcoholism, also on suitability for carrying out activities related to narcotic drugs, psychotropic substances and their precursors and the conclusion of the internal affairs bodies on conducting the relevant check | ||
89. | Storage rooms, safes and cabinets shall be kept closed. After the end of the working day they shall be sealed and (or) stamped. Keys, seal and (or) sealer shall be kept by the responsible person | ||
90. | Availability of a first aid kit | ||
91. | Availability of a signboard indicating the name of the pharmaceutical activity subject, its organizational and legal form and operation mode in the state and Russian languages | ||
92. | Availability of information on telephone numbers and addresses of territorial subdivisions of the state body in the sphere of circulation of medicines and medical devices in a place convenient for the population’s viewing | ||
93. | Ensuring traceability of medicinal products labeled with identification means by providing by participants of circulation of medicinal products and entities in the sphere of circulation of medicinal products and medical devices of information on launch into circulation, on sale and (or) transfer, as well as on withdrawal of labeled medicinal products from circulation on the territory of the Republic of Kazakhstan | ||
94. |
Compliance with the rules of advertising of medicinal products and medical devices: | ||
95. |
Non-admission of advertising of medicines and medical devices: | ||
96. | Availability of a document on calibration and (or) verification of a medical device that is a measuring instrument | ||
97. | Compliance with the requirement that the medical equipment in use, at the time of acceptance, was new, unused, the latest or a serial model, free of defects | ||
98. | Availability of a log of the technical condition of medical equipment subject to service | ||
99. | Availability of documents confirming current and major repairs | ||
100. | Availability of documents confirming warranty service (not less than thirty-seven months from the date of commissioning and periodicity recommended by the manufacturer) consisting of periodic inspection of the technical condition of medical equipment (at least once a year). | ||
101. |
Availability in operated medical equipment: | ||
102. | Presence of facts of operation of medical equipment not provided with service maintenance, removed from service maintenance, or operation of medical equipment by personnel without special training, not trained in the use of medical equipment. | ||
103. | Presence of facts of unjustified idling of medical equipment (absence of measures for restoration of serviceable condition) |
Designated person (s)
__________________________________________________________________________
position, signature
________________________________________________________________________________
surname, name, patronymic (if any)
The head of the control subject
__________________________________________________________________________
position, signature
__________________________________________________________________________
surname, name, patronymic (if any)
Appendix 18
to the joint order
of the Minister of Healthcare
of the Republic of Kazakhstan dated
November 15, 2018 № ҚР ДСМ-32
and the Minister of National Economy
of the Republic of Kazakhstan
dated November 15, 2018 №70
Checklist in the field of circulation of medicines and medical devices regarding subjects (objects) of pharmaceutical activities engaged in the production of medicines and medical devices
Footnote. Appendix 18 – as amended by the joint order of the Acting Minister of Healthcare of the Republic of Kazakhstan dated 24.05.2023 №87 and the Minister of National Economy of the Republic of Kazakhstan dated 24.05.2023 № 77 (effective ten calendar days after the date of its first official publication).
State body that appointed inspection/preventive control with a visit to the
control subject (object) _______________________________________________________
__________________________________________________________________________
Act on appointing inspection / preventive control with a visit to
control subject (object)
_____________________________________________________________
__________________________________________________________________________
№, date
Name of the control subject (object)
_________________________________________________________________________
(Individual Identification Number), Business Identification Number of the
control subject (object)
_______________________________________________________________
Location address
№ | List of requirements | Compliance with requirements | Non-compliance with requirements |
1. | Compliance with all production processes of medicines and medical devices (GMP) | ||
2. | Availability of state registration in the Republic of Kazakhstan of medicinal substances used in production, with the exception of those produced under Good Manufacturing Practice conditions | ||
3. | Availability of forwarding documents for medicines and medical productsв | ||
4. | Carrying out activities for the production of medicines or wholesale distribution of medicines by suppliers of substances or intermediate products | ||
5. | Compliance of substances, excipients, consumables and packaging materials with the registration dossier | ||
6. | Incoming control of raw materials (substances, auxiliary materials), materials, semi-finished products, components; intermediate control during the production process, control of finished pharmaceutical products | ||
7. | Availability of a quality assurance system, documentation and control of its efficacy in production | ||
8. | Ensuring registration of all technological and auxiliary operations during the production of a separate series of medicines and medical devices | ||
9. | Compliance with the requirements for maintaining documentation of all production processes and materials used in production, its storage order | ||
10. | Compliance with stability testing, shelf-life establishment, and revalidation of medications. | ||
11. | Ensuring that the number of samples is sufficient for testing when necessary (arbitration tests) | ||
12. | Availability of markings indicating the status of manufactured products, initial products, packaging materials | ||
13. | Quality control of materials, intermediate products, finished products. | ||
14. | Maintaining of database of side effects of medicines and medical devices | ||
15. | Availability of a health specialist certificate for each pharmacy worker | ||
16. | Availability of a state license for pharmaceutical activities and of attachments for subtypes of activity or notification of the commencement of activity. Compliance with the types and subtypes of activities declared upon receipt of the state license and attachment to it | ||
17. | Ensuring storage and transportation in accordance with the conditions established by the manufacturer in the regulatory and technical document on monitoring the quality and safety of medicines, in the instructions for medical use for medicines and medical devices, operational documents (for the medical device), indicated in the labeling of their packages | ||
18. | Ensuring safety, storage conditions and handling of various groups of medicines and medical devices by complying with the requirements for design, arrangement, composition, size of the areas, equipment of premises (areas) for storage of medicines and medical devices and their operation, ensuring the safety | ||
19. | Observance of storing medicines and medical devices separate from other products to avoid any impact on them, protection from negative impact of light, temperature, moisture and other external factors | ||
20. | Keeping records of the expiry dates of medicines and medical devices on paper or electronic media | ||
21. | Storage of medicines and medical devices in designated and clearly marked storage areas | ||
22. | Provision of storage premises, including a refrigerating room (chamber) with appropriate equipment for control of temperature, air humidity (thermometers, hygrometers, other types of devices) and their location on the internal walls of the premises away from heating devices based on the results of testing of temperature fluctuation zones for cold and warm seasons | ||
23. | Observance of separation during storage of all medicines and medical devices depending on the pharmacological group, administration method, aggregate state, physicochemical properties, exposure to various environmental factors | ||
24. | Availability of isolated storage space for pending, expired, returned, withdrawn, presumably counterfeit, recalled and rejected medicinal products | ||
25. | Provision of weather protection in the receiving and discharge areas. Availability of equipment in receiving and discharge areas (ventilation/air conditioning system, hygrometer, thermometer), container cleaning equipment. Availability of an equipped area for inspection of received products | ||
26. | Separation of acceptance, quarantine, defective, discharge and storage areas. Availability of a room in which medicines are stored in quarantine, clearly marked and with limited access | ||
27. | Availability of common non-combustible buildings with insulation by non-combustible walls from neighboring premises that meet fire safety requirements in the absence of separate storage facilities for flammable substances, provision of premises with supply and exhaust ventilation | ||
28. | Storage of flammable medicines separately from other medicines: provision of fireproof and stable racks and pallets, storage of flammable and combustible liquids in built-in fireproof cabinets with doors at least 0.7 meters wide and 1.2 meters high | ||
29. | Storage of flammable liquids isolated in separate rooms in glass or metal containers from other groups | ||
30. |
Compliance with the storage of flammable and combustible liquid medicines that should not be stored: | ||
31. | Compliance with isolated storage of calcium hypochloride, taking into account its properties | ||
32. | Compliance with the storage of flammable liquids with constant monitoring of the condition of containers, their tightness and serviceability | ||
33. | Implementation of measures in the storage of explosive medicines against their contamination by dust | ||
34. | Compliance with separate storage of explosive and flammable medicines containing acids and alkalis | ||
35. | Ensuring protection of cylinders with oxygen and flammable gases from heat sources, contact with oil and other greasy substances, and their storage in isolated rooms or under sheds | ||
36. | Observance of conditions of storing dressings in a dry ventilated area in cabinets, drawers, on racks, pallets, trays, in conditions ensuring cleanliness | ||
37. | Compliance with the conditions of storing medical instruments, devices, appliances, equipment in dry heated rooms at room temperature, with relative humidity not exceeding 65 percent | ||
38. | Compliance with the requirements for interior finishing of premises (areas) for storing medicines and ensuring cleanliness of storage premises and equipment | ||
39. | Providing protection against the entry of insects, rodents or other animals, and presence of preventive pest control program | ||
40. |
Separation of rest rooms, dressing rooms, showers and toilets for employees from storage rooms (areas). Food, beverages, tobacco products, as well as medicines for personal use shall not be stored in storage rooms (areas). | ||
41. |
Provision of the necessary equipment and inventory in drug storage areas: | ||
42. | Availability of a document on calibration (verification) of equipment used for control and monitoring of storage conditions | ||
43. | Availability of a developed and approved emergency plan in case of malfunction of the refrigeration room (chamber), refrigeration equipment or power outage, emergency situations | ||
44. | Availability of developed and approved instructions for cleaning and disinfection of equipment. The used equipment shall be in good condition and kept in proper cleanliness | ||
45. | Availability of a person responsible for ensuring the safety of the quality of medicines and medical devices at the facilities storing medicines and medical devices. | ||
46. | Availability of a commission for the destruction of medicines and medical devices unsuitable for sale and medical use. | ||
47. | Availability of acts on the destruction of medicines and medical devices unsuitable for sale and medical use. | ||
48. |
Availability of secondary package labeling including the following information: | ||
49. |
Availability of primary packaging labeling indicating the following information: | ||
50. | Organization of work to monitor adverse reactions and (or) lack of efficacy of medicines and medical devices, appointment of responsible persons for monitoring side effects of medicines and medical devices | ||
51. | Provision by the responsible person to the authorized organization of information about side effects and (or) lack of efficacy of medicines and medical devices. Transmission of message cards through the portal of an authorized organization online containing a mandatory minimum amount of information | ||
52. | Compliance with the deadlines for submitting a completed report card about adverse reactions (actions) and (or) efficacy to the authorized organization in cases of detection | ||
53. | Absence of facts of procurement, production, storage, advertising, use, provision and sale of medicines and medical devices that have not passed state registration in the Republic of Kazakhstan | ||
54. | Absence of facts of production, importation, storage, use and sale of counterfeit medicines and medical devices | ||
55. | Absence of facts of sale of medicines and medical devices, the quality of which is not confirmed by the conclusion on safety and quality | ||
56. | Absence of facts of storage, use and sale of expired medicines and medical devices | ||
57. | Compliance of the medicinal product with the requirements of the regulatory document on quality and safety control of the medicinal product and medical device (based on the results of safety and quality assessment of samples withdrawn as doubtful) | ||
58. |
Compliance with the requirements for storage, accounting, destruction of medicines containing narcotic drugs, psychotropic substances and precursors (including substances): | ||
59. | Availability of a list of persons who have conclusions from psychiatrists and narcologists about the absence of drug addiction, substance abuse, chronic alcoholism, as well as about suitability for carrying out activities related to narcotic drugs, psychotropic substances and their precursors and the conclusion of the internal affairs bodies on conducting the relevant check | ||
60. | Storage rooms, safes and cabinets shall be kept closed. After the end of the working day they shall be sealed and (or) stamped. Keys, seal and (or) sealer shall be kept with the responsible person | ||
61. | Availability of a first aid kit | ||
62. | Availability of a signboard indicating the name of the pharmaceutical activity subject, its organizational and legal form and operation mode in the state and Russian languages | ||
63. | Availability of information on telephone numbers and addresses of territorial subdivisions of the state body in the sphere of circulation of medicines and medical devices in a place convenient for the population’s viewing | ||
64. | Ensuring traceability of medicinal products labeled with identification means by providing by participants of circulation of medicinal products and entities in the sphere of circulation of medicinal products and medical devices of information on launch into circulation, on sale and (or) transfer, as well as on withdrawal of labeled medicinal products from circulation on the territory of the Republic of Kazakhstan | ||
65. |
Compliance with the rules of advertising medicinal products and medical devices: | ||
66. |
Non-admission of advertising of medicines and medical devices: | ||
67. | Compliance with manufacturer's price limits | ||
68. | Availability of a certificate of compliance with the requirements of the Good Manufacturing Practice (GMP) Standard |
Designated person (s)
__________________________________________________________________________
position, signature
__________________________________________________________________________
surname, name, patronymic (if any)
The head of the control subject
__________________________________________________________________________
position, signature
__________________________________________________________________________
surname, name, patronymic (if any).
| Appendix 19 to the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated November 15, 2018 № ҚР ДСМ-32 and the Minister of National Economy of the Republic of Kazakhstan dated November 15, 2018 №70 |
Checklist in the field of circulation of medicines and medical devices regarding subjects (objects) of pharmaceutical activity, engaged in manufacturing of medicines and medical devices
Footnote. Appendix 19 as amended by the joint order of the Acting Minister of Healthcare of the Republic of Kazakhstan dated 24.05.2023 №87 and the Minister of National Economy of the Republic of Kazakhstan dated 24.05.2023 № 77 (effective ten calendar days after the date of its first official publication).
State body that appointed inspection/preventive control with a visit to the
control subject (object) _______________________________________________________
__________________________________________________________________________
Act on appointing inspection / preventive control with a visit to
control subject (object)
_______________________________________________________________________
__________________________________________________________________________
№, date
Name of the control subject (object)
__________________________________________________________________________
(Individual Identification Number), Business Identification Number of the
control subject (object)
_______________________________________________________________
Location address
№ | List of requirements | Compliance with requirements | Non-compliance with requirements |
1. | Availability of a workplace of a pharmacist-analyst equipped with a standard set of measuring instruments, testing equipment, laboratory utensils, auxiliary materials | ||
2. | Implementation of preventive (precautionary) measures, acceptance control of starting materials (drug substance, excipient), written, organoleptic, random questioning control, random physical and chemical control, control at dispensing of manufactured medicinal products | ||
3. | Availability and maintenance of checklists when manufacturing medicines according to prescriptions and requirements of medical organizations | ||
4. | Availability and maintenance of the logbook of organoleptic, physical and chemical control results numbered, laced, sealed and signed by the head of the pharmacy. | ||
5. | Presence of state registration in the Republic of Kazakhstan for medicinal substances used in manufacturing, except for those produced under Good Manufacturing Practice conditions | ||
6. | Implementation by substance suppliers of activities in the manufacture of medicines or in the wholesale distribution of medicines | ||
7. | Maintaining and monitoring of the expiration dates of medicines and medical devices | ||
8. | Ensuring technology for the manufacture of a medicinal product, in accordance with the requirements of the general articles of the State Pharmacopoeia of the Republic of Kazakhstan | ||
9. |
Implementation of preventive (precautionary) measures: | ||
10. |
Design of glass stoppered bottle (pharmacy containers) as follows: | ||
11. | Presence and maintenance of the Logbook of registration of the results of control of medicinal substances for authenticity | ||
12. | Monitoring compliance with drug manufacturing technology by a pharmacy technician | ||
13. | Acceptance control of starting materials (drug substance, auxiliary substance) used for manufacturing of medicinal products (delivery note, quality certificate of the manufacturing plant), compliance of series on samples of drug substances and auxiliary substances with the series specified in the accompanying documentation, compliance with storage and transportation conditions, as well as identification of drug substances and auxiliary materials according to the indicators “Packaging”, “Labeling” and “Description”. | ||
14. |
Performing a written control of medications manufactured by the pharmacy by completing a checklist immediately after manufacturing the medication. | ||
15. | Conducting random survey control of medications manufactured in the pharmacy | ||
16. | Organoleptic control of appearance, color, odor, homogeneity, absence of visible mechanical inclusions in solutions | ||
17. |
Random physical control by checking the total mass or volume of the medicinal product, the number and mass of individual doses included in the given medicinal product (but no less than three doses) and the quality of capping. | The following are subject to selective physical control: | |
18. | Primary and secondary control for mechanical inclusions in the process of manufacturing solutions | ||
19. | Chemical control for the following indicators: 1) authenticity, purity tests and permissible limits of impurities (qualitative analysis); 2) quantitative determination (quantitative analysis) of medicinal substances included in its composition | ||
20. | Complete chemical analysis of purified water | ||
21. |
Control over dispensing by checking all manufactured medicinal products, including homeopathic medicinal products for compliance of: | ||
22. | Ensuring that the results of control of individual stages of manufacturing solutions for injections and infusions are recorded in the log of control results of individual stages of manufacturing solutions for injections and infusions | ||
23. | Availability of a nomenclature of concentrates, semi-finished products and intra-pharmacy preparation of medicinal products manufactured in the pharmacy, annually approved by an accredited testing laboratory with which a contract on control and analytical services has been concluded | ||
24. | Holding by each pharmacy worker of a health specialist certificate | ||
25. | Availability of a state license for pharmaceutical activities and of attachments for subtypes of activity or notification of the commencement of activity. Compliance with the types and subtypes of activities declared upon receipt of the state license and attachment to it | ||
26. | Ensuring storage and transportation in accordance with the conditions established by the manufacturer in the regulatory and technical document on monitoring the quality and safety of medicines, in the instructions for medical use for medicines and medical devices, operational documents (for the medical device), indicated in the labeling of their packages | ||
27. | Ensuring safety, storage conditions and handling of various groups of medicines and medical devices by complying with the requirements for design, arrangement, composition, size of areas, equipment of premises (areas) for storage of medicines and medical devices and their operation, ensuring the safety | ||
28. | Storage of medicines and medical devices separate from other products to avoid any impact on them, protection from negative impact of light, temperature, moisture and other external factors | ||
29. | Keeping records of the expiry dates of medicines and medical devices on paper or electronic medium | ||
30. | Storage of medicines and medical devices in designated and clearly marked storage areas | ||
31. | Provision of storage premises, including a refrigerating room (chamber) with appropriate equipment for control of temperature, air humidity (thermometers, hygrometers, other types of devices) and their location on the internal walls of the premises away from heating devices based on the results of testing of temperature fluctuation zones for cold and warm seasons | ||
32. | Observance of separation during storage of all medicines and medical devices depending on the pharmacological group, method of administration, aggregate state, physicochemical properties, exposure to various environmental factors | ||
33. | Availability of isolated storage space for pending, expired, returned, withdrawn, presumably counterfeit, recalled and rejected medicinal products | ||
34. | Provision of weather protection in the receiving and discharge areas. Availability of equipment in receiving and discharge areas (ventilation/air conditioning system, hygrometer, thermometer), container cleaning equipment. Availability of an equipped area for inspection of received products | ||
35. | Separation of receiving, quarantine, defective, discharge and storage areas. Availability of a clearly labeled and restricted access quarantine room where medicines are stored. | ||
36. | Availability of common non-combustible buildings with insulation by non-combustible walls from neighboring premises that meet fire safety requirements in the absence of separate storage facilities for flammable substances, provision of premises with supply and exhaust ventilation | ||
37. | Storage of flammable medicines separately from other medicines: provision of fireproof and stable racks and pallets, storage of flammable and combustible liquids in built-in fireproof cabinets with doors at least 0.7 meters wide and 1.2 meters high | ||
38. | Storage of flammable liquids isolated in separate rooms in glass or metal containers from other groups | ||
39. |
Compliance with the storage of flammable and combustible liquid medicines that should not be stored: | ||
40. | Compliance with isolated storage of calcium hypochloride, taking into account its properties | ||
41. | Compliance with the storage of flammable liquids with constant monitoring of the condition of containers, their tightness and serviceability | ||
42. | Implementation of measures in the storage of explosive medicines against their contamination by dust | ||
43. | Compliance with separate storage of explosive and flammable medicines containing acids and alkalis | ||
44. | Ensuring protection of cylinders with oxygen and flammable gases from heat sources, contact with oil and other greasy substances, and their storage in isolated rooms or under sheds | ||
45. | Observance of storage conditions of dressings in a dry ventilated area in cabinets, drawers, on racks, pallets, trays, in conditions ensuring cleanliness | ||
46. | Compliance with the storage conditions of medical instruments, devices, appliances, equipment in dry heated rooms at room temperature, with relative humidity not exceeding 65 percent | ||
47. | Compliance with the requirements for interior finishing of premises (areas) for storing medicines and ensuring cleanliness of storage premises and equipment | ||
48. | Providing protection against the entry of insects, rodents or other animals, and presence of preventive pest control program | ||
49. |
Separation of rest rooms, dressing rooms, showers and toilets for employees from storage rooms (areas). Food, beverages, tobacco products, as well as medicines for personal use shall not be stored in storage rooms (areas). | ||
50. |
Provision of the necessary equipment and inventory in drug storage premises: | ||
51. | Availability of a document on calibration (verification) of equipment used for control and monitoring of storage conditions | ||
52. | Availability of a developed and approved emergency plan in case of malfunction of the refrigeration room (chamber), refrigeration equipment or power outage, emergency situations | ||
53. | Availability of developed and approved instructions for cleaning and disinfection of equipment. The used equipment shall be in good condition and kept in proper cleanliness | ||
54. | Availability of a person responsible for ensuring the safety of the quality of medicines and medical devices at facilities storing medicines and medical devices | ||
55. | Availability of a commission for the destruction of medicines and medical devices unsuitable for sale and medical use | ||
56. | Availability of acts on the destruction of medicines and medical devices unsuitable for sale and medical use | ||
57. |
Availability of secondary package labeling including the following information: | ||
58. |
Availability of primary packaging labeling indicating the following information: | ||
59. | Organization of work to monitor adverse reactions and (or) lack of effectiveness of medicines and medical devices, appointment of responsible persons for monitoring side effects of medicines and medical devices | ||
60. | Provision by the responsible person to the authorized organization of information about side effects and (or) lack of effectiveness of medicines and medical devices. Transmission of message cards through the portal of an authorized organization online containing a mandatory minimum amount of information | ||
61. | Compliance with the deadlines for submitting a completed report card about adverse reactions (actions) and (or) effectiveness to the authorized organization in cases of detection | ||
62. | Absence of facts of procurement, production, storage, advertising, use, provision and sale of medicines and medical devices that have not passed state registration in the Republic of Kazakhstan | ||
63. | Absence of facts of production, importation, storage, use and sale of counterfeit medicines and medical devices | ||
64. | Absence of facts of sale of medicines and medical devices, the quality of which is not confirmed by the conclusion on safety and quality | ||
65. | Absence of facts of storage, use and sale of expired medicines and medical devices | ||
66. | Compliance of the medicinal product with the requirements of the regulatory document on quality and safety control of the medicinal product and medical device (based on the results of safety and quality assessment of samples withdrawn as doubtful) | ||
67. |
Compliance with the requirements for storage, accounting, destruction of medicines containing narcotic drugs, psychotropic substances and precursors (including substances): | ||
68. | Availability of the list of persons who have conclusions from psychiatrists and narcologists about the absence of drug addiction, substance abuse, chronic alcoholism, as well as about suitability for carrying out activities related to narcotic drugs, psychotropic substances and their precursors and the conclusion of the internal affairs bodies on conducting the relevant check | ||
69. | Storage rooms, safes and cabinets shall be kept closed. After the end of the working day, they shall be sealed and (or) stamped. Keys, seal and (or) sealer shall be kept with the responsible person | ||
70. | Availability of a first aid kit | ||
71. | Availability of a signboard indicating the name of the pharmaceutical activity subject, its organizational and legal form and operation mode in the state and Russian languages | ||
72. | Availability of information on telephone numbers and addresses of territorial subdivisions of the state body in the sphere of circulation of medicines and medical devices in a place convenient for the population’s viewing | ||
73. | Ensuring traceability of medicinal products labeled with identification means by providing by participants of circulation of medicinal products and entities in the sphere of circulation of medicinal products and medical devices of information on launch into circulation, on sale and (or) transfer, as well as on withdrawal of labeled medicinal products from circulation on the territory of the Republic of Kazakhstan | ||
74. |
Compliance with the rules of advertising medicinal products and medical devices: | ||
75. |
Non-admission of advertising of medicines and medical devices: |
Designated person (s)
__________________________________________________________________________
position, signature
_________________________________________________________________________
surname, name, patronymic (if any)
The head of the control subject
_________________________________________________________________________
position, signature
_________________________________________________________________________
surname, name, patronymic (if any).
| Appendix 20 to the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated November 15, 2018 № ҚР ДСМ-32 and the Minister of National Economy of the Republic of Kazakhstan dated November 15, 2018 №70 |
Checklist in the field of circulation of medicines and medical devices regarding subjects (objects) of pharmaceutical activity, engaged in wholesale sale of medicines and medical devices
Footnote. Appendix 20 – as amended by the joint order of the Acting Minister of Healthcare of the Republic of Kazakhstan dated 24.05.2023 №87 and the Minister of National Economy of the Republic of Kazakhstan dated 24.05.2023 № 77 (effective ten calendar days after the date of its first official publication).
State body that appointed inspection/preventive control with a visit to the
control subject (object) _______________________________________________________
__________________________________________________________________________
Act on appointing inspection / preventive control with a visit to the
control subject (object)
__________________________________________________________________________
____________________________________________________________________
№, date
Name of the control subject (object)
__________________________________________________________________________
(Individual Identification Number), Business Identification Number of the
control subject (object)
_______________________________________________________________
Location address
Designated person (s)
__________________________________________________________________________
position, signature
__________________________________________________________________________
surname, name, patronymic (if any)
The head of the control subject
__________________________________________________________________________
position, signature
__________________________________________________________________________
surname, name, patronymic (if any).
Checklist in the field of circulation of medicines and medical devices regarding subjects (objects)
of pharmaceutical activity, engaged in retail sale of medicines and medical devices
Footnote. Appendix 21 – as amended by the joint order of the Acting Minister of Healthcare of the Republic of Kazakhstan dated 24.05.2023 №87 and the Minister of National Economy of the Republic of Kazakhstan dated 24.05.2023 № 77 (effective ten calendar days after the date of its first official publication).
State body that appointed inspection/preventive control with a visit to the
control subject (object) _______________________________________________________
__________________________________________________________________________
Act on appointing inspection / preventive control with a visit to
control subject (object)
_________________________________________________________________________
№, date
Name of the control subject (object)
__________________________________________________________________________
(Individual Identification Number), Business Identification Number of the
control subject (object)
_______________________________________________________________
Location address
№ | List of requirements | Compliance with requirements | Non-compliance with requirements |
1. | Ensuring the sale of medical products related to measuring instruments, in the presence of a certificate of approval of the type of measuring instruments or a certificate of metrological certification of medical measuring equipment | ||
2. | Ensuring the sale of prescription drugs on a doctor’s prescription | ||
3. | Ensuring that medicines sold without a doctor's prescription are placed on display cases | ||
4. | Registration of invalid prescriptions in the Register of invalid prescriptions with the stamp “Prescription invalid”. | ||
5. |
Compliance with the validity term of recipes: | ||
6. | Ensuring provision of reliable information regarding: 1) correct and rational application or use; 2) possible side effects and contraindications; 3) interaction with other medicinal products, precautions in their application or use; 4) expiration dates and rules of storage at home; 5) rules of operation, completeness of medical products | ||
7. | Availability of a document on calibration and (or) verification of a medical device that is a measuring instrument | ||
8. | Making sure that the used medical equipment, at the time of acceptance was new, unused, newest or serial model, free of defects. | ||
9. | Availability of a log of the technical condition of medical equipment subject to service | ||
10. | Availability of documents confirming current and major repairs | ||
11. | Availability of documents confirming warranty service (not less than thirty-seven months from the date of commissioning and periodicity recommended by the manufacturer) consisting of periodic inspection of the technical condition of medical equipment (at least once a year). | ||
12. |
Availability in operated medical equipment: | ||
13. | Presence or absence of facts of operation of medical equipment not provided with service maintenance, removed from service maintenance, or operation of medical equipment by personnel without special training, not trained in the use of the medical equipment. | ||
14. | Presence or absence of facts of unjustified idling of medical equipment (absence of measures for restoration of serviceable condition) | ||
15. | Ensuring implementation of preventive measures: 1) quality control during acceptance and sales; 2) compliance with the rules and shelf life of medicines, keeping records of medicines with a limited shelf life; 3) serviceability and accuracy of weighing instruments; 4) checking the correctness of the prescription, its validity period, compliance of the prescribed doses with the patient’s age, compatibility of ingredients, and the norms for one-time dispensing; 5) keeping records of the validity periods of safety and quality assessment conclusions | ||
16. | Ensuring acceptance of medicines and medical devices with verification of: 1) compliance of quantity, completeness, integrity of containers, compliance of packaging, labeling with regulatory documents, availability of instructions for medical use of medicines and medical devices in the state and Russian languages; availability of an operational document for a medical device; 2) compliance with the name, dosage, packaging, quantity, batch (series) of products specified in the accompanying documents; 3) presence in the accompanying documents of a certificate of conformity or a reference to it in the invoice for the release of goods | ||
17. | Availability in a place convenient for viewing of information on the list of medicines and specialized medicinal products for free provision of certain categories of citizens with certain diseases at the outpatient level | ||
18. | Availability of lists and specimen signatures of persons entitled to sign prescriptions for free receipt of medicines approved by the head of the relevant healthcare organization in retail sales facilities that have relevant agreements with local government healthcare authorities | ||
19. |
Ensuring the placement in a place convenient for familiarization of: | ||
20. |
Ensuring that information of the following nature is placed in a place visible to visitors: "Medicines may not be returned and exchanged"; | ||
21. | Compliance with the maximum price for the trade name of a medicinal product in retail sales | ||
22. | Holding by each pharmacy worker of a health specialist certificate | ||
23. | Availability of a state license for pharmaceutical activities and of attachments for subtypes of activity or notification of the commencement of activity. Compliance with the types and subtypes of activities declared upon receipt of the state license and attachment to it | ||
24. | Ensuring storage and transportation in accordance with the conditions established by the manufacturer in the regulatory and technical document on monitoring the quality and safety of medicines, in the instructions for medical use for medicines and medical devices, operational documents (for the medical device), indicated in the labeling of their packages | ||
25. | Ensuring safety, storage conditions and handling of various groups of medicines and medical devices by complying with the requirements for design, arrangement, composition, size of areas, equipment of premises (areas) for storage of medicines and medical devices and their operation, ensuring the safety | ||
26. | Maintaining separate storage of medicines and medical devices from other products to avoid any impact on them, protection from negative impact of light, temperature, moisture and other external factors | ||
27. | Keeping records of the expiry dates of medicines and medical devices on paper or electronic media | ||
28. | Storage of medicines and medical devices in designated and clearly marked storage areas | ||
29. | Provision of storage premises, including a refrigerating room (chamber) with appropriate equipment for control of temperature, air humidity (thermometers, hygrometers, other types of devices) and their location on the internal walls of the premises away from heating devices based on the results of testing of temperature fluctuation zones for cold and warm seasons | ||
30. | Observance of separation during storage of all medicines and medical devices depending on the pharmacological group, method of administration, aggregate state, physicochemical properties, exposure to various environmental factors | ||
31. | Availability of isolated storage space for pending, expired, returned, withdrawn, presumably counterfeit, recalled and rejected medicinal products | ||
32. | Provision of weather protection in the receiving and discharge areas. Availability of equipment in receiving and shipping areas (ventilation/air conditioning system, hygrometer, thermometer), container cleaning equipment. Availability of an equipped area for inspection of received products | ||
33. | Separation of receiving, quarantine, defective, discharge and storage areas. Availability of a clearly labeled and restricted access quarantine room where medicines are stored. | ||
34. | Availability of common non-combustible buildings with insulation by non-combustible walls from neighboring premises that meet fire safety requirements in the absence of separate storage facilities for flammable substances, provision of premises with supply and exhaust ventilation | ||
35. | Storage of flammable medicines separately from other medicines: provision of fireproof and stable racks and pallets, storage of flammable and combustible liquids in built-in fireproof cabinets with doors at least 0.7 meters wide and 1.2 meters high | ||
36. | Storage of flammable liquids isolated in separate rooms in glass or metal containers from other groups | ||
37. |
Compliance with the storage of flammable and combustible liquid medicines that should not be stored: | ||
38. | Compliance with isolated storage of calcium hypochloride, taking into account its properties | ||
39. | Compliance with the storage of flammable liquids with constant monitoring of the condition of containers, their tightness and serviceability | ||
40. | Implementation of measures in the storage of explosive medicines against their contamination by dust | ||
41. | Compliance with separate storage of explosive and flammable medicines containing acids and alkalis | ||
42. | Ensuring protection of cylinders with oxygen and flammable gases from heat sources, contact with oil and other greasy substances, and their storage in isolated rooms or under sheds | ||
43. | Observance of conditions of storing dressings in a dry ventilated area in cabinets, drawers, on racks, pallets, trays, in conditions ensuring cleanliness | ||
44. | Compliance with the conditions of storing medical instruments, devices, appliances, equipment in dry heated rooms at room temperature, with relative humidity not exceeding 65 percent | ||
45. | Compliance with the requirements for interior finishing of premises (areas) for storing medicines and ensuring cleanliness of storage premises and equipment | ||
46. | Providing protection against the entry of insects, rodents or other animals, and presence of preventive pest control program | ||
47. |
Separation of rest rooms, dressing rooms, showers and toilets for employees from storage rooms (areas). Food, beverages, tobacco products, as well as medicines for personal use shall not be stored in storage rooms (areas). | ||
48. |
Provision of the necessary equipment and inventory in drug storage areas: | ||
49. | Availability of a document on calibration (verification) of equipment used for control and monitoring of storage conditions | ||
50. | Availability of a developed and approved emergency plan in case of malfunction of the refrigeration room (chamber), refrigeration equipment or power outage, emergency situations | ||
51. | Availability of developed and approved instructions for cleaning and disinfection of equipment. The equipment used shall be in good condition and kept in proper cleanliness | ||
52. | Availability of a person responsible for ensuring the safety of the quality of medicines and medical devices at facilities storing medicines and medical devices | ||
53. | Availability of a commission for the destruction of medicines and medical devices unsuitable for sale and medical use | ||
54. | Availability of acts on the destruction of medicines and medical devices unsuitable for sale and medical use | ||
55. |
Availability of secondary package labeling including the following information: | ||
56. |
Availability of primary packaging labeling indicating the following information: | ||
57. | Organization of work to monitor adverse reactions and (or) lack of effectiveness of medicines and medical devices, appointment of responsible persons for monitoring side effects of medicines and medical devices | ||
58. | Provision by the responsible person to the authorized organization of information about side effects and (or) lack of effectiveness of medicines and medical devices. Transmission of message cards through the portal of an authorized organization online containing a mandatory minimum amount of information | ||
59. | Compliance with the deadlines for submitting a completed report card about adverse reactions (actions) and (or) effectiveness to the authorized organization in cases of detection | ||
60. | Absence of facts of procurement, production, storage, advertising, use, provision and sale of medicines and medical devices that have not passed state registration in the Republic of Kazakhstan | ||
61. | Absence of facts of production, importation, storage, use and sale of counterfeit medicines and medical devices | ||
62. | Absence of facts of sale of medicines and medical devices, the quality of which is not confirmed by the conclusion on safety and quality | ||
63. | Absence of facts of storage, use and sale of expired medicines and medical devices | ||
64. | Compliance of the medicinal product with the requirements of the regulatory document on quality and safety control of the medicinal product and medical device (based on the results of safety and quality assessment of samples withdrawn as doubtful) | ||
65. |
Compliance with the requirements for storage, accounting, destruction of medicines containing narcotic drugs, psychotropic substances and precursors (including substances): | ||
66. | Availability of the list of persons who have conclusions from psychiatrists and narcologists about the absence of drug addiction, substance abuse, chronic alcoholism, as well as about suitability for carrying out activities related to narcotic drugs, psychotropic substances and their precursors and the conclusion of the internal affairs bodies on conducting the relevant check | ||
67. | Storage rooms, safes and cabinets shall be kept closed. After the end of the working day, they shall be sealed and (or) stamped. Keys, seal and (or) sealer shall be kept with the responsible person | ||
68. | Availability of a first aid kit | ||
69. | Availability of a signboard indicating the name of the pharmaceutical activity subject, its organizational and legal form and operation mode in the state and Russian languages | ||
70. | Availability of information on telephone numbers and addresses of territorial subdivisions of the state body in the sphere of circulation of medicines and medical devices in a place convenient for the population’s viewing | ||
71. | Ensuring traceability of medicinal products labeled with identification means by providing by participants of circulation of medicinal products and entities in the sphere of circulation of medicinal products and medical devices of information on launch into circulation, on sale and (or) transfer, as well as on withdrawal of labeled medicinal products from circulation on the territory of the Republic of Kazakhstan | ||
72. |
Compliance with the rules of advertising of medicinal products and medical devices: | ||
73. |
Non-admission of advertising of medicines and medical devices: |
Designated person (s)
__________________________________________________________________________
position, signature
__________________________________________________________________________
surname, name, patronymic (if any)
The head of the control subject
__________________________________________________________________________
position, signature
__________________________________________________________________________
surname, name, patronymic (if any).
Checklist
Footnote. Appendix 22 - as amended by the joint order of the Acting Minister of Healthcare of the Republic of Kazakhstan dated 31.03.2025 № 27 and the Deputy Prime Minister - Minister of National Economy of the Republic of Kazakhstan dated 07.04.2025 № 16 (shall come into effect upon expiry of ten calendar days after the date of its first official publication).
in the field of providing medical services (assistance)
_______________________________________________________________________
in accordance with Article 138
______________________________________________________________________
of the Entrepreneurial Code of the Republic of Kazakhstan in relation to _ entities (objects)
providing pathological diagnostics name of a homogeneous group of entities (objects) of
control
______________________________________________________________________
State body that has appointed an inspection/preventive control with a visit to the entity (object)
of control
______________________________________________________________________
_______________________________________________________________________
Act on the appointment of an inspection/preventive control with a visit to the entity
(object) of control ________________________________________________________
________________________________________________________________№, date
Name of the entity (object) of control _________________________________________
_______________________________________________________________________
(Individual identification number), business identification number
of the entity (object) of control ______________________________________________
_______________________________________________________________________
Address of location _______________________________________________________
_______________________________________________________________________
_______________________________________________________________________
№ | List of requirements | Complies with the requirements | Does not comply with the requirements |
1 | 2 | 3 | 4 |
1 | Availability of documentation confirming the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social medical insurance on a free basis | ||
2 | Availability of a concluded co-insurance agreement for professional liability of medical workers | ||
3 | Presence of a record in the medical documentation confirming compliance with the requirement to register a refusal to accept biological material, attached to a copy of the referral for analysis of biological material in the pathology department in a separate folder ("Rejected samples"), as well as in a separate journal ("Rejected samples") | ||
4 | Presence of a record in the medical documentation confirming the compliance by the pathologist with the requirement for the participation of a laboratory technician in the work based on the act of cutting, macroscopic examination and macroscopic description of the biological material. If it is necessary to obtain additional clinical information at the stage of macroscopic examination of the biological material, the specialist doctor who sent the material for examination shall be involved | ||
5 | Presence of a record in the medical documentation confirming compliance with the requirement that the thickness of tissue fragments is 5 millimeters (hereinafter referred to as mm), the average diameter shall be no more than 24 mm | ||
6 | Presence of a record in the medical documentation (form № 002/у "Protocol (card) of pathological examination № ____"), confirming the microscopic description of the biopsy (surgical) and autopsy material | ||
7 | Presence of a record in the medical documentation confirming compliance with the requirement for issuing the results of a pathomorphological study with entries in the journals of the established form by a medical registrar or laboratory technician | ||
8 | Presence of a record in the medical documentation confirming compliance with the requirement for storing tissue samples in paraffin blocks carried out in a single archive organized according to the principle of continuous numbering | ||
9 | Presence of a record in the medical documentation confirming compliance with the requirement for storing tissue samples in paraffin blocks in a specially equipped dry and cool room, using specialized archival systems and adapted containers, as well as storing microscopic preparations in specialized archival systems | ||
10 | Presence of a record in the medical documentation confirming compliance with the requirement to place the microscopic specimens in boxes in such a way that the slides related to one case are arranged in one indivisible block | ||
11 | Presence of a record in the medical documentation confirming compliance with the requirement for the laboratory technician to sort and prepare biological and medical waste for disposal | ||
12 | Availability of written consent of the spouse or one of the close relatives, or legal representative for conducting pathological diagnostics in the event of an undetermined immediate cause of death | ||
13 | Presence of a record in the medical documentation confirming compliance with the requirement for an independent expert(s) to conduct a pathological autopsy of the deceased at the request of the spouse, close relatives or legal representative | ||
14 | Presence of a record in the medical documentation confirming compliance with the requirement for the issuance of a medical death certificate (preliminary, final) by a physician specializing in "pathological anatomy (adult, pediatric)" on the day of the pathological autopsy | ||
15 | Presence of a record in the medical documentation confirming compliance with the requirement for the registration of autopsy results | ||
16 | If there is a record in the medical documentation confirming compliance with the requirement to terminate the autopsy upon detection of signs of violent death during the postmortem examination of the corpse, the head of the medical organization shall notify the judicial and investigative bodies in writing of the incident to decide on the transfer of the corpse for forensic medical examination. A doctor specializing in "pathological anatomy (adult, pediatric)" shall take measures to preserve the body, organs and tissues of the corpse for further forensic medical examination. A protocol shall be drawn up for the part of the postmortem examination performed, at the end of which the basis for further forensic medical examination shall be indicated. In each case of an interrupted postmortem autopsy, the pathologist shall notify in writing the head of the department, the administration of the healthcare organization where the death occurred, immediately after the autopsy is interrupted. | ||
17 | Presence of a record in the medical documentation confirming compliance with the requirement to send an emergency notification to the state body in the field of sanitary and epidemiological welfare of the population by a doctor specializing in "pathological anatomy (adult, pediatric)" in the event of primary detection during an autopsy of signs of an acute infectious disease, food or industrial poisoning, an unusual reaction to a vaccination | ||
18 | Presence of a record in the medical documentation confirming compliance with the requirement for pathological examination of all deceased persons in medical organizations, including maternity organizations, newborn children (regardless of how long after birth they showed signs of life) and stillborn fetuses weighing 500 grams or more at a gestational age of 22 weeks or more, including after termination of pregnancy (spontaneous, for medical and social reasons) with mandatory histological examination of the placenta and registration of a medical certificate of perinatal death | ||
19 | Presence of a record in the medical documentation confirming compliance with the requirement of the head of the pathological anatomy department to ensure that autopsies of deceased newborns and stillborns shall be performed with mandatory histological examination of tissue fragments and organs and inclusion in the protocol of the pathological anatomy examination | ||
20 | Presence of a record in the medical documentation confirming compliance with the requirement by the heads of healthcare organizations and heads of the pathological anatomy department of the organization for the necessary virological and bacteriological examination of autopsy materials of deceased newborns, stillborn babies and placentas, using for this purpose the appropriate laboratories of healthcare organizations or government agencies and organizations in the field of sanitary and epidemiological welfare of the population | ||
21 | Presence of a record in the medical documentation confirming compliance with the requirement for the issuance of a medical certificate of perinatal death by a physician specializing in "pathological anatomy (adult, pediatric)" on the day of the pathological autopsy (preliminary, final, instead of preliminary) | ||
22 |
Presence of a record in the medical documentation confirming compliance with the requirement by a physician specializing in "pathological anatomy (adult, pediatric)" when issuing a pathological diagnosis based on the results of a pathological autopsy: | ||
23 | Compliance with the requirement for the preparation and maintenance of primary medical documentation | ||
24 |
Presence of a record in the medical documentation confirming compliance with the requirement for recording materials from pathological studies (biopsy, surgical and autopsy material): | ||
25 |
Presence of a record in the medical documentation confirming compliance with the requirement to not issue the protocol of the pathological examination for review by the spouse, close relatives, legal representatives or other persons. | ||
26 | Presence of a record in the medical documentation confirming compliance with the requirement to issue originals or copies of pathological examination reports at the request of the inquiry and preliminary investigation bodies, the prosecutor, lawyer and (or) the court in connection with the investigation or trial, as well as at the request of government agencies in the field of providing medical services (assistance) | ||
27 |
Presence of a record in the medical documentation confirming compliance with the requirements for conducting cytological studies, including the following | ||
28 | Presence of a record in the medical documentation confirming compliance with the requirement for the laboratory technician to receive, initially sort and register biological material received by the cytology laboratory, perform macroscopic examination, describe the biological material, and process the biological material (preparation, fixation, staining, conclusion, sorting of cytological micropreparations) | ||
29 | Availability of documentation on compliance with the requirement for microscopic examination at the first stage by a laboratory technician, then by a cytologist | ||
30 | Presence of a record in the medical documentation confirming compliance with the requirement to involve a physician (specialist) if it is necessary to obtain additional clinical information at the stage of microscopic examination of the biological material who sent the material for examination. The final microscopic examination of smears and the preparation of the protocol of the examination results shall be performed by a cytologist | ||
31 | Presence of a record in the medical documentation confirming compliance with the requirement for the doctor specializing in "pathological anatomy (adult, pediatric)" to establish the category and the reason for the discrepancy between the final clinical and pathological diagnoses |
Official(s) ________________________________ ____________
position signature_______________________________________
surname, first name, patronymic (if any)
Head of the subject of control _________________ ____________
position signature________________________________________
surname, first name, patronymic (if any)
| Appendix 23 to the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated November 15, 2018, № ҚР ДСМ-32 and the Minister of National Economy of the Republic of Kazakhstan dated November 15, 2018, № 70 |
Checklist
Footnote. Appendix 23 - as amended by the joint order of the Acting Minister of Healthcare of the Republic of Kazakhstan dated 31.03.2025 № 27 and the Deputy Prime Minister - Minister of National Economy of the Republic of Kazakhstan dated 07.04.2025 № 16 (shall come into effect upon expiry of ten calendar days after the date of its first official publication).
in the field of providing medical services (assistance)
_______________________________________________________________________
in accordance with Article 138
_____________________________________________________________________
of the Entrepreneurial Code of the Republic of Kazakhstan in relation to _ entities (objects)
regardless of activity name of a homogeneous group of entities (objects) of control
______________________________________________________________________
State body that has appointed an inspection/preventive control
with a visit to the entity (object) of control
______________________________________________________________________
_______________________________________________________________________
Act on the appointment of an inspection/preventive control with a visit to the entity
(object) of control ________________________________________________________
________________________________________________________________№, date
Name of the entity (object) of control _________________________________________
_______________________________________________________________________
(Individual identification number), business identification number
of the entity (object) of control ______________________________________________
_______________________________________________________________________
Address of location _______________________________________________________
_______________________________________________________________________
_______________________________________________________________________
№ | List of requirements | Complies with the requirements | Does not comply with the requirements |
1 | 2 | 3 | 4 |
1 | Availability of a specialist certificate for admission to clinical practice | ||
2 | Availability of a license and/or license supplement | ||
3 | Compliance of premises or buildings based on ownership or a lease agreement, or a gratuitous use agreement for real estate (loan), or a trust management of property, or a public-private partnership agreement with the standards for organizing the provision of medical care by specialized services for the subtypes of medical activity provided, as well as corresponding to sanitary rules establishing sanitary and epidemiological requirements for healthcare facilities | ||
4 | Availability of functioning medical and (or) special equipment, apparatus and instruments, devices, furniture, inventory, transport and other means (if necessary), approved in the standards for the organization of the provision of medical care of specialized services for the subtypes of medical activity provided and the minimum standards for equipping healthcare organizations with medical products | ||
5 | Availability of specialists in the types of activities provided | ||
6 | Availability of specialization or improvement and other types of advanced training over the last 5 (five) years in the provided subtypes of medical activity (except for graduates of internship, residency, secondary educational institution who completed training no later than 5 (five) years at the time of inspection). |
Official(s) ________________________________ ____________
position signature_______________________________________
surname, first name, patronymic (if any)
Head of the subject of control _________________ ____________
position signature________________________________________
surname, first name, patronymic (if any)
| Appendix 24 to the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated November 15, 2018, № ҚР ДСМ-32 and the Minister of National Economy of the Republic of Kazakhstan dated November 15, 2018, № 70 |
Checklist
Footnote. The joint order is supplemented with Appendix 24 in accordance with the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated 29.05.2023 № 90 and the Minister of National Economy of the Republic of Kazakhstan dated 29.05.2023 № 91 (shall come into effect upon expiry of ten calendar days after the date of its first official publication); as amended by the joint order of the Acting Minister of Healthcare of the Republic of Kazakhstan dated 31.03.2025 № 27 and the Deputy Prime Minister - Minister of National Economy of the Republic of Kazakhstan dated 07.04.2025 № 16 (shall come into effect upon expiry of ten calendar days after the date of its first official publication).
in the field of providing medical services (assistance)
_______________________________________________________________________
in accordance with Article 138
____________________________________________________________________
of the Entrepreneurial Code of the Republic of Kazakhstan in relation to _ entities (objects)
providing assistance in the field of nuclear medicine
name of a homogeneous group of entities (objects) of control
______________________________________________________________________
State body that has appointed an inspection/preventive control
with a visit to the entity (object) of control
_____________________________________________________________________
_______________________________________________________________________
Act on the appointment of an inspection/preventive control with a visit to the entity
(object) of control ________________________________________________________
________________________________________________________________№, date
Name of the entity (object) of control _________________________________________
_______________________________________________________________________
(Individual identification number), business identification number
of the entity (object) of control ______________________________________________
_______________________________________________________________________
Address of location _______________________________________________________
_______________________________________________________________________
_______________________________________________________________________
№ | List of requirements | Complies with the requirements | Does not comply with the requirements |
1 | 2 | 3 | 4 |
1 | Availability of documentation confirming the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social medical insurance on a free basis | ||
2 | Availability of a concluded co-insurance agreement for professional liability of medical workers | ||
3 | Availability of supporting documentation on the compliance of the treatment and diagnostic measures with the recommendations of clinical protocols | ||
4 |
Availability of documentation confirming the status of the Nuclear Medicine Center (hereinafter referred to as the Center) as a structural subdivision of a multidisciplinary hospital or an independent medical organization providing medical care to the population of the Republic of Kazakhstan under the RND and (or) RNT. | ||
5 |
Presence of a record in the documentation confirming the main tasks and areas of activity of organizations providing medical care in the field of nuclear medicine and compliance with the main tasks: | ||
6 | Availability of medical documentation confirming the provision of medical care using nuclear medicine methods within the framework of the guaranteed volume of free medical care, voluntary medical insurance and on a paid basis. | ||
7 |
Availability of documentation confirming the provision of specialized medical care in the field of nuclear medicine in outpatient, hospital-replacing, and inpatient settings on a planned basis: | ||
8 | Availability of documentation confirming referral of patients for PET/CT, PET/MRI, SPECT, SPECT/CT examination in the RND department by specialized professionals | ||
9 | Availability of medical documentation confirming the conduct of radioisotope (radionuclide) studies according to clinical protocols, documented procedures, the specific diagnostic method used, with mandatory compliance with radiation safety measures for the patient and personnel as indicated | ||
10 | Availability of a signed informed consent of the patient for a radioisotope (radionuclide) study before undergoing this study indicating the activity of the RPD used, after which an examination by a doctor and a nurse shall be carried out | ||
11 | Presence of a record in the medical documentation confirming that the nuclear medicine physician has interpreted the results of the study after the completion of the diagnostic procedure. In complex cases with mandatory "double reading" - double-read, by conducting double dependent reading (the image is read twice; during the second reading, the result of the first reading is available), PET, PET/CT, PET/MRI, SPECT, SPECT/CT studies by specialists in the field of nuclear medicine and a final diagnostic conclusion shall be issued. | ||
12 | Availability of medical documentation confirming referral of patients to the RNT department after preliminary examination and decision on the need for its implementation based on clinical data with the participation of the head of the department or a nuclear medicine physician in accordance with the list of diseases for RNT. For receiving medical care in inpatient settings for oncological diseases, a referral shall be issued by a multidisciplinary group created in healthcare organizations providing oncological care; the medical advisory commission of the medical organization for non-oncological diseases, according to clinical indications, prescribes whole-body scintigraphy with a diagnostic activity of the radiopharmaceutical drug "Sodium iodide I-131" 185 MBq. | ||
13 | Presence of a record in the medical documentation confirming the performance of RNT in inpatient conditions in "active" wards and (or) on beds. After taking the RPD, the patient is a source of beta-gamma radiation, in connection with which, daily doctor's visits shall be carried out via audio and video communication. The radiation safety engineer (dosimetrist) shall daily record the dose rate from patients via a measuring device and a stationary dose rate measurement system. | ||
14 |
Presence of a record in the medical documentation confirming the delivery of the patient's corpse with the introduced RPD of "active" wards to a specially allocated freezer located in the radionuclide support unit of the RNT unit (in the radioactive waste storage facility) in case of death. In the freezer, the corpse shall be kept until an acceptable level of radioactive decay (at a distance of 1 meter from the body surface - 20 mSv/h), then the corpse shall be transported. | ||
15 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical reports) on the clinical audit conducted by the Patient Support Service and internal expertise and its assessment according to the following criteria: | ||
16 | Availability of informed written consent from the patient for transfusion of blood and its components | ||
17 | Presence of a record in the medical documentation (form № 001/у "Medical record of an inpatient") confirming the examination of the recipient before the transfusion for markers of blood-borne infections (HIV, hepatitis B and C), as well as recommendations in the discharge summary on the need for repeated testing for HIV and hepatitis B and C in the primary health care organization at the place of attachment after 1, 3, 6 months | ||
18 | Availability of a contract with the medical organization for the purchase and delivery of blood and its components | ||
19 | Availability of documentation (internal document approved by the first head) confirming the distribution of functions of employees involved in each stage of blood transfusion and its components | ||
20 | Presence of a record in the medical documentation (result of a group study on the ABO system and Rh factor, screening of irregular anti-erythrocyte antibodies according to form 098/у or a record in the electronic form 001/у "Medical record of an inpatient"), confirming the immunohematological examination of recipients to ensure the safety of transfusion therapy | ||
21 | Presence of a record in the medical documentation confirming the establishment of indications for the administration of blood, its components based on clinical manifestations of deficiency or dysfunction of cellular or other blood components, confirmed by laboratory data ("Pre-transfusion epicrisis" insert sheet 6 to the medical record of an inpatient, form 001/у) | ||
22 | Availability of documentation (internal document approved by the first head) confirming continuous training of personnel involved in transfusion therapy and admission to transfusion care of medical personnel and mid-level medical personnel | ||
23 | Availability of medical documentation confirming the transfer of assets from the hospital to the primary health care facility for patients who have undergone a blood transfusion | ||
24 | Availability of medical documentation ("Diary", insert sheet 2 to the medical record of an inpatient f 001/у), confirming control over the effectiveness of blood transfusion and its components | ||
25 | Maintaining forms of accounting documentation in the field of healthcare (Form № 003/у "Form for recording the movement of blood, its components and diagnostic standards" on electronic and (or) paper; Insert sheet 6 to the medical record of an inpatient, Form 001/у "Pre-transfusion epicrisis", "Protocol for transfusion of components", " Transfusion sheet", Form № 006/у "Form for recording transfusion of blood, its components, drugs", Form № 007/у "Form for recording recipients of blood and its components") on electronic and (or) paper |
Official(s) ________________________________ ____________
position signature_______________________________________
surname, first name, patronymic (if any)
Head of the subject of control _________________ ____________
position signature________________________________________
surname, first name, patronymic (if any)
| Appendix 25 to the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated November 15, 2018 № ҚР ДСМ-32 and the Minister of National Economy of the Republic of Kazakhstan dated November 15, 2018 №70 |
Checklist in the field of circulation of medicines and medical devices regarding the state
expert organization in the sphere of circulation of medicines and medical devices
Footnote. The joint order as supplemented by Appendix 25 pursuant to the joint order of the acting Minister of Healthcare of the Republic of Kazakhstan dated 24.05.2023 № 87 and the Minister of National Economy of the Republic of Kazakhstan dated 24.05.2023 № 77(effective ten calendar days after the date of its first official publication).
State body that appointed inspection/preventive control with a visit to
to control subject (object)
_______________________________________________________
__________________________________________________________________________
Act on appointing inspection/ preventive control with a visit to control subject (object)
_______________________________________________________________________
__________________________________________________________________________
№, date
Name of control subject (object)
__________________________________________________________________________
(Individual Identification Number), Business Identification Number of the control
subject (object)
_______________________________________________________________
Location address
__________________________________________________________________________
№ | List of requirements | Compliance with requirements | Non-compliance with requirements |
1. | Violation of the rules of state registration, re-registration of a medicinal product or medical device, introduction of amendments to the registration dossier of a medicinal product or medical device by the State Expert Organization in the field of circulation of medicinal products and medical devices | ||
2. | Violation of the procedure for expert examination of medicines conducted by a state expert organization in the sphere of circulation of medicines and medical devices when conducting an expert examination of the quality and safety of vaccines |
Designated person (s) ____________________________________ ____________
position, signature
________________________________________________________________________
surname, name, patronymic (if any)
The head of the control subject _______________________________ ____________
position, signature
________________________________________________________________________
surname, name, patronymic (if any)
| Appendix 26 to the joint order of the Minister of Healthcare of the Republic of Kazakhstan dated November 15, 2018, № ҚР ДСМ-32 and the Minister of National Economy of the Republic of Kazakhstan dated November 15, 2018, № 70 |
Checklist
Footnote. The joint order is supplemented by Appendix 26 in accordance with the joint order of the Acting Minister of Healthcare of the Republic of Kazakhstan dated 31.03.2025 № 27 and the Deputy Prime Minister - Minister of National Economy of the Republic of Kazakhstan dated 07.04.2025 № 16 (shall come into effect upon expiry of ten calendar days after the date of its first official publication).
in the field of providing medical services (assistance)
_______________________________________________________________________
in accordance with Article 138
_____________________________________________________________________
of the Entrepreneurial Code of the Republic of Kazakhstan in relation to _ entities (objects)
providing medical care for occupational pathology name of a homogeneous group of entities
(objects) of control
______________________________________________________________________
State body that has appointed an inspection/preventive control with a visit to the entity (object)
of control
______________________________________________________________________
_______________________________________________________________________
Act on the appointment of an inspection/preventive control with a visit to the entity
(object) of control ________________________________________________________
________________________________________________________________№, date
Name of the entity (object) of control _________________________________________
_______________________________________________________________________
(Individual identification number), business identification number
of the entity (object) of control ______________________________________________
_______________________________________________________________________
Address of location _______________________________________________________
_______________________________________________________________________
_______________________________________________________________________
№ | List of requirements | Complies with the requirements | Does not comply with the requirements |
1 | 2 | 3 | 4 |
Provision of medical care for occupational pathology at the outpatient and polyclinic level | |||
1 | Availability of documentation confirming the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social medical insurance on a free basis. | ||
2 | Availability of a concluded co-insurance agreement for professional liability of medical workers | ||
3 | Availability of written voluntary consent of the patient or his/her legal representative for invasive interventions and the implementation of treatment and diagnostic measures | ||
4 | Availability of supporting documentation on the compliance of the treatment and diagnostic measures with the recommendations of clinical protocols | ||
5 |
Availability of documentation confirming compliance with the requirements for organizing and conducting the MCC: | ||
6 | Availability of documentation on the implementation of dynamic monitoring of patients with an established diagnosis of an occupational disease in accordance with clinical protocols and recommendations of an occupational pathologist | ||
7 | Availability of documentation on preliminary and periodic mandatory medical examinations | ||
8 |
Availability of documentation on the creation and approval by the medical organization of the composition of the medical commission for conducting a medical examination and drawing up the Calendar Plan (hereinafter referred to as the Plan), which determines the type and scope of laboratory and other studies taking into account the specifics of harmful production factors, the time and terms of the work of the medical commission after receiving the lists of the contingent subject to medical examination agreed upon with the territorial divisions of the department of the state body in the field of sanitary and epidemiological welfare of the population. The Plan shall be agreed upon with the administration of the organization (enterprise) (employer). | ||
9 | Availability of a final act on summarizing the results of mandatory periodic medical examinations with the preparation and submission of a consolidated report to the territorial division of the state body in the field of sanitary and epidemiological welfare of the population (including in transport). | ||
10 | Availability of a conclusion on the compliance of a healthcare entity with the provision of high-tech medical care | ||
11 |
Presence of a record in the medical documentation confirming the diagnosis of an occupational disease with the performance of work (official) duties. | ||
12 | Availability of a contract for the provision of paid medical services in healthcare organizations. Availability of documents establishing the fact of co-payment. | ||
13 |
Presence of a record in the medical documentation confirming compliance with the requirements for examining temporary disability, issuing a sheet and a certificate of temporary disability (form № 001/y "Medical record of an inpatient", form 052/y "Medical record of an outpatient", stubs of sheets of temporary incapacity for patients, form № 025/y "Journal for recording the conclusions of the medical advisory commission", form № 029/y "Registration book of sheets of temporary disability", form № 037/y "Certificate № ______ on temporary disability of a student, a student of a college, vocational school, on illness, quarantine and other reasons for the absence of a child attending school, a preschool organization (underline as appropriate)", form № 038/y "Certificate № ______ on temporary disability" and others): | ||
14 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical reports) on the clinical audit conducted by the Patient Support Service and internal expertise and its assessment according to the following criteria: | ||
15 | Availability of medical documentation confirming compliance with the requirements for providing a guaranteed volume of free medical care | ||
Provision of medical care for occupational pathology at hospital-replacing, the inpatient level | |||
16 | Availability of documentation confirming the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social medical insurance on a free basis | ||
17 | Availability of a concluded co-insurance agreement for professional liability of medical workers | ||
18 | Availability of a conclusion on the compliance of a healthcare entity with the provision of high-tech medical care | ||
19 | Availability of written voluntary consent of the patient or his/her legal representative for invasive interventions and the implementation of treatment and diagnostic measures | ||
20 | Availability of a contract for the provision of paid medical services in healthcare organizations. Availability of documents establishing the fact of co-payment | ||
21 |
Presence of a record in the medical documentation confirming compliance with the requirements for the provision of medical care for occupational pathology in inpatient settings: | ||
22 |
Availability of documentation confirming compliance with the requirements for conducting an expert occupational pathology commission (EOPC): | ||
23 |
Presence of a record in the medical documentation confirming compliance with the requirements for examining temporary disability, issuing a sheet and a certificate of temporary disability (form № 001/у "Inpatient Medical Record", form 052/у "Outpatient Medical Record", stubs of sheets of temporary incapacity for patients, form № 025/у "Journal for recording the conclusions of the medical advisory commission", form № 029/у "Registration book of sheets of temporary disability", form № 037/у "Certificate № __________ on temporary disability of a student, a student of a college, vocational school, on illness, quarantine and other reasons for the absence of a child attending school, a preschool organization (underline as appropriate)", form № 038/у "Certificate № ______ on temporary disability" and others): | ||
24 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical reports) on the clinical audit conducted by the Patient Support Service and internal expertise and its assessment according to the following criteria: | ||
25 | Availability of medical documentation on the provision of medical rehabilitation for the underlying disease (form № 001/у "Inpatient Medical Record", form № 047/у "Rehabilitation Record"). | ||
26 | Availability of documentation confirming the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social medical insurance on a free basis | ||
Checklist
Footnote. The joint order is supplemented by Appendix 27 in accordance with the joint order of the Acting Minister of Healthcare of the Republic of Kazakhstan dated 31.03.2025 № 27 and the Deputy Prime Minister - Minister of National Economy of the Republic of Kazakhstan dated 07.04.2025 № 16 (shall come into effect upon expiry of ten calendar days after the date of its first official publication).
in the field of providing medical services (assistance)
________________________________________________________________________
in accordance with Article 138
______________________________________________________________________
of the Entrepreneurial Code of the Republic of Kazakhstan in relation to _ entities (objects)
providing medical assistance to persons held in pre-trial detention facilities and institutions of
the penal system name of a homogeneous group of entities (objects) of control
______________________________________________________________________
State body that has appointed an inspection/preventive control with a visit to the entity (object)
of control
_____________________________________________________________________
_______________________________________________________________________
Act on the appointment of an inspection/preventive control with a visit to the entity
(object) of control ________________________________________________________
________________________________________________________________№, date
Name of the entity (object) of control _________________________________________
_______________________________________________________________________
(Individual identification number), business identification number
of the entity (object) of control ______________________________________________
_______________________________________________________________________
Address of location _______________________________________________________
_______________________________________________________________________
_______________________________________________________________________
№ | List of requirements | Complies with the requirements | Does not comply with the requirements |
1 | 2 | 3 | 4 |
1 | Availability of a report (appointment) from a medical worker on the need to be transported to a medical institution of a healthcare organization to provide medical care | ||
2 | Availability of documentation confirming the provision of medical care included in the guaranteed volume of free medical care and (or) the system of compulsory social medical insurance on a free basis for stateless persons whose freedom is restricted | ||
3 | Availability of a concluded co-insurance agreement for professional liability of medical workers | ||
4 | Availability in the medical documentation of a conclusion of the MCC on the referral to the MSE of the examined (re-examined) person whose freedom is restricted | ||
5 |
Presence of a record in the medical documentation confirming compliance with the requirements for the provision of oncological care to convicts in the form of outpatient and polyclinic care: | ||
6 |
Availability of documentation (internal orders, regulations, protocols, questionnaires, analytical reports) on the clinical audit conducted by the Patient Support Service and the internal examination of convicts, and its assessment according to the following criteria: | ||
7 |
Presence of a record in the medical documentation confirming compliance with the requirements for the provision of surgical (abdominal, thoracic, proctological) care to convicted patients at the outpatient level: | ||
8 | Availability of documentation on compliance with the requirements of primary health care organizations for dynamic monitoring of individuals with chronic diseases, compliance with the frequency and duration of monitoring, mandatory minimum and frequency of diagnostic tests | ||
9 |
Presence of a record in the medical documentation confirming compliance with the requirements for the provision of traumatological and orthopedic care at the outpatient level: | ||
10 | Availability of documentation confirming the provision of paid medical services to persons held in pre-trial detention facilities and penal institutions, in the conditions of medical organizations providing medical care to persons held in pre-trial detention facilities and penal institutions with the involvement of specialists from other medical organizations on their initiative. | ||
11 | Presence of a record in the medical documentation confirming a commission examination or referral for consultation to specialized healthcare professionals in disease profiles | ||
12 |
Presence of a record in the medical documentation confirming the appointment of a visit to an obstetrician-gynaecologist: | ||
13 | Availability of informed written consent from the patient for transfusion of blood and its components | ||
14 | Presence of a record in the medical documentation (form № 001/у "Medical record of an inpatient") confirming the examination of the recipient before the transfusion for markers of blood-borne infections (HIV, hepatitis B and C), as well as recommendations in the discharge summary on the need for repeated testing for HIV and hepatitis B and C in the primary health care organization at the place of attachment after 1, 3, 6 months | ||
15 | Availability of a contract with the medical organization for the purchase and delivery of blood and its components | ||
16 | Availability of documentation (internal document approved by the first head) confirming the distribution of functions of employees involved in each stage of blood transfusion and its components | ||
17 | Presence of a record in the medical documentation (result of a group study on the ABO system and Rh factor, screening of irregular anti-erythrocyte antibodies according to form 098/у or a record in the electronic form 001/у "Medical record of an inpatient"), confirming the immunohematological examination of recipients to ensure the safety of transfusion therapy | ||
18 | Presence of an entry in the medical documentation ("Pre-transfusion epicrisis", insert sheet 6 to the medical record of an inpatient, form 001/у), confirming the establishment of indications for the administration of blood, its components based on clinical manifestations of deficiency or dysfunction of cellular or other blood components, confirmed by laboratory data | ||
19 | Availability of documentation (internal document approved by the first head) confirming continuous training of personnel involved in transfusion therapy and admission to transfusion care of medical personnel and mid-level medical personnel | ||
20 | Availability of medical documentation confirming the transfer of assets from the hospital to the emergency medical care facility for patients who have undergone a blood transfusion | ||
21 | Availability of medical documentation ("Diary", insert sheet 2 to the medical record of an inpatient f 001/у), confirming control over the effectiveness of blood transfusion and its components | ||
22 | Maintaining forms of accounting documentation in the field of healthcare (Form № 003/у "Form for recording the movement of blood, its components and diagnostic standards" on electronic and (or) paper; Insert sheet 6 to the medical record of an inpatient form 001/у "Pre-transfusion epicrisis", "Protocol for transfusion of components", "Transfusion sheet", Form № 006/у "Form for recording transfusion of blood, its components, drugs", Form № 007/у "Form for recording recipients of blood and its components") on electronic and (or) paper |
