of January 6, 2021 No. KR DSM-3, 6 of January, 2021 No. 5
About introduction of amendments to the joint order of the Minister of Health of the Republic of Kazakhstan of November 15, 2018 No. KR DSM-32 and the Minister of national economy of the Republic of Kazakhstan of November 15, 2018 No. 70 "About approval of criteria for evaluation of risk degree and checking sheets in spheres of quality of rendering medical services, drug circulation and medical products"
WE ORDER:
1. Bring in the joint order of the Minister of Health of the Republic of Kazakhstan of November 15, 2018 No. KR DSM-32 and the Minister of national economy of the Republic of Kazakhstan of November 15, 2018 No. 70 "About approval of criteria for evaluation of risk degree and checking sheets in spheres of quality of rendering medical services, drug circulation and medical products" (it is registered in the Register of state registration of regulatory legal acts at No. 17744, it is published on November 23, 2018 in Reference control bank of regulatory legal acts of the Republic of Kazakhstan in electronic form) the following changes:
state preamble in the following edition:
"According to Items 2 and 3 of Article 141, Item 1 of article 143 of the Entrepreneurial code of the Republic of Kazakhstan of October 29, 2015 we ORDER:";
in Item 1:
11) to exclude the subitem;
to be reworded as follows appendix 1 to the specified joint order according to appendix 1 to this order;
to be reworded as follows appendix 2 to the specified joint order according to appendix 2 to this order;
to be reworded as follows appendix 3 to the specified joint order according to appendix 3 to this order;
to be reworded as follows appendix 4 to the specified joint order according to appendix 4 to this order;
to be reworded as follows appendix 8 to the specified joint order according to appendix 5 to this order;
to be reworded as follows appendix 10 to the specified joint order according to appendix 6 to this order;
to exclude appendix 11 to the specified joint order;
to be reworded as follows appendix 12 to the specified joint order according to appendix 7 to this order;
to be reworded as follows appendix 13 to the specified joint order according to appendix 8 to this order;
to be reworded as follows appendix 14 to the specified joint order according to appendix 9 to this order;
to be reworded as follows appendix 15 to the specified joint order according to appendix 10 to this order;
2. To provide to committee of medical and pharmaceutical control of the Ministry of Health of the Republic of Kazakhstan in the procedure established by the legislation of the Republic of Kazakhstan:
1) state registration of this joint order in the Ministry of Justice of the Republic of Kazakhstan;
2) placement of this joint order on Internet resources of the Ministry of Health of the Republic of Kazakhstan and the Ministry of national economy of the Republic of Kazakhstan after its official publication;
3) within ten working days after state registration of this joint order in the Ministry of Justice of the Republic of Kazakhstan submission to Legal department of the Ministry of Health of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1) and 2) of this Item.
3. To impose control of execution of this joint order on the supervising vice-Minister of Health of the Republic of Kazakhstan.
4. This joint order becomes effective after ten calendar days after day of its first official publication.
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Minister of national economy of the Republic of Kazakhstan
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__________ R. Dalenov |
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Minister of Health of the Republic of Kazakhstan
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__________ A. Tsoi
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It is approved Committee on legal statistics and special accounting of the Prosecutor General's Office of the Republic of Kazakhstan |
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Appendix 1
to the joint Order of the Minister of Health of the Republic of Kazakhstan and the Minister of national economy of the Republic of Kazakhstan of January 6, 2021 No. KR DSM-3, 6 of January, 2021 No. 5
Appendix 1
to the joint Order of the Minister of Health of the Republic of Kazakhstan and the Minister of national economy of the Republic of Kazakhstan of November 15, 2018 No. KR DSM-32, 15 of November, 2018 No. 70
1. These Criteria for evaluation of degree of risks in the field of quality of rendering medical services (help) (further – Criteria) are developed according to article 30 of the Code of the Republic of Kazakhstan of July 7, 2020 "About health of the people and health care system", article 141 of the Entrepreneurial code of the Republic of Kazakhstan of October 29, 2015 and Rules of forming of system of risks assessment by the state bodies approved by the order of the acting minister of national economy of the Republic of Kazakhstan of July 31, 2018 No. 3 (it is registered in the Register of state registration of regulatory legal acts at No. 17371).
2. In these Criteria the following concepts are used:
1) assessment period – certain time period for which the risks assessment by objective and subjective criteria based on reporting yielded is carried out, results of monitoring of the automated information systems, results of the previous checks and other sources of information. For subjects of control assessment period used in Criteria – once a half-year;
2) considerable violations – violations, including the discrepancies to requirements of the legislation in the field of health care which are not relating to gross and insignificant violations;
Insignificant violations – violations of requirements of the legislation of the Republic of Kazakhstan in the field of health care which non-compliance entailed and (or) can entail 3) formally allowed, but not done any notable harm to the population;
4) risk in the field of rendering medical services – probability of damnification of life or to health of the person, legitimate interests of physical persons and legal entities, the states as a result of implementation of medical activities of the subject of control;
5) gross violations – intentional or careless explicit and fundamental breach of the legislation of the Republic of Kazakhstan in the field of health care which non-compliance entailed and (or) can entail heavy effects to health of the population;
6) objective criteria for evaluation of risk degree (further – objective criteria) – the criteria used for selection of subjects (objects) of control depending on risk degree in the field of rendering medical services when implementing activities and which are not depending directly on separate subject (object) of control;
7) subjective criteria for evaluation of risk degree (further – subjective criteria) – the criteria for evaluation of risk degree used for selection of subjects (objects) of control for carrying out preventive control and special procedure for conducting checks depending on results of activities of specific subject (object) of control.
3. Criteria for evaluation of risk degree for special procedure for conducting checks and for preventive control and supervision with visit of subject (object) of control and supervision are created by means of objective and subjective criteria.
4. Objective criteria are created by means of the following stages:
1) risk identification;
2) distribution of subjects (objects) of control on risk degrees (high and not carried to high).
5. The objects of obstetric aid and the stationary organizations incorporating departments of pathology of newborns belong to high risk.
Concerning subjects (objects) of high risk are performed in special procedure with frequency once a year.
6. In case of acceptance in operation of object of the high importance after approval of the semi-annual schedule of conducting checks, it is brought in the schedule of conducting checks the next half-year with frequency of checks once a year.
7. For determination of subjective criteria for evaluation of degree of risks the following sources of information are used:
1) results of the previous checks and special procedure for conducting checks (at the same time severity of violations is established in case of non-compliance with the requirements established in checking sheets);
2) results of monitoring of the data received from the automated information systems;
3) availability and the number of the confirmed claims, addresses from physical persons and legal entities for last year.
8. Subjective criteria are developed for the purpose of realization of the principle of encouragement of the fair checked subjects (objects) in the form of release them from conducting checks on special procedure.
If at subject (object) external complex assessment (accreditation) on activities compliance to accreditation standards is carried out and the certificate on accreditation for the checked period is provided, then the subject (object) is exempted from checks the next calendar year.
9. Determination of risk group of the objects of the high importance relating to one subject (legal entity) is carried out for each object separately.
10. Forming of the schedule of conducting checks, subjects (objects) of control is constituted proceeding from the principles of the minimum need and sufficiency, encouragement of the fair checked subjects, concentration of control on violators.
11. Subjective criteria for evaluation of risk degree concerning checks by special procedure with distribution on degree of the importance of violations and sources of information it is determined according to appendix 1 to these Criteria.
In case of identification of one gross violation, to the checked subject (object) the exponent of risk 100 is equated and concerning it it is performed on special procedure.
If gross violations are not revealed, for measure definition of risk degree the total indicator on violations of considerable and insignificant degree is calculated.
In case of measure definition of considerable violations the coefficient of 0,7 is applied and this indicator is calculated by the following formula:
SRZ = (SP2 x 100/SP1) x 0,7
where:
SRZ – indicator of considerable violations;
SP1 – total quantity of required considerable violations;
SR2-the number of the revealed considerable violations.
In case of measure definition of insignificant violations the coefficient of 0,3 is applied and this indicator is calculated by the following formula:
SRN = (SP2 x 100/SP1) x 0,3
where:
SRN – indicator of insignificant violations;
SP1 – total quantity of required insignificant violations;
SR2-the number of the revealed insignificant violations.
The general exponent of risk (SP) is calculated on scale from 0 to 100 and is determined by summing of indicators of considerable and insignificant violations by the following formula:
SP = SRZ + SRN
where:
SP – general exponent of risk;
SRZ-indicator of considerable violations;
SRN-indicator of insignificant violations.
12. On indicators the checked subject (object):
1) it is exempted from special procedure for conducting checks based on semi-annual schedules the next half-year established in criteria for evaluation of risk degree of regulatory state agency – in case of exponent of risk from 0 to 60;
2) it is not exempted from special procedure for conducting checks based on semi-annual schedules – in case of exponent of risk from 61 to 100 inclusive.
13. Objective criteria are created by means of the following stages:
1) risk identification;
2) distribution of subjects (objects) of control on risk degrees (high and not carried to high).
14. Reference of subjects of control to risk degree is performed taking into account the following objective criteria:
1) the level of danger (complexity) of subject (object) depending on the performed activities;
2) scales of weight of possible negative effects of harm in the course of implementation of medical activities;
3) possibilities of adverse effect on health of the person, legitimate interests of physical persons and legal entities, states.
15. After risk identification, subjects (objects) of control are distributed on two risk degrees (high and not carried to high).
Subjective criteria for the purpose of carrying out preventive control with visit of subject (object) of control are applied to subjects (objects) of control carried by objective criteria to high risk.
16. Subjects (objects) of control giving out-patient and polyclinic help, stationary, emergency medical service and medical aircraft, the laboratory services performing activities in spheres of pathoanatomical diagnostics and prevention of HIV, service of blood belong to high risk.
17. Not carried to high risk - the subjects (objects) of control performing recovery treatment and medical rehabilitation, giving pre-medical help, palliative care and sisterly leaving, and also the organizations performing activities in the field of forming of healthy lifestyle.
18. For determination of subjective criteria for evaluation of degree of risks the following sources of information are used:
1) results of the previous checks and preventive control with visit of subjects (objects) of control (at the same time severity of violations is established in case of non-compliance with the requirements established in checking sheets);
2) results of monitoring of the data received from the automated information systems;
3) results of monitoring of the reporting data represented by the subject of control;
4) analysis results of information, received from authorized bodies and the organizations;
5) availability and the number of the confirmed claims, addresses from physical persons and legal entities for last year.
19. For assessment of subjects of control by subjective criteria data of electronic information resources of authorized body in the field of health care and medical information systems are used.
20. Subjective criteria in the field of quality of rendering medical services are subdivided into three extents of violations: rough, considerable, insignificant.
Subjective criteria for carrying out preventive control with visit of the subject of control with distribution on degree of the importance of violations and sources of information are given in appendix 2 to these Criteria. Discrepancy criterion determines the corresponding extent of violations.
21. The following procedure of payments of exponent of risk is applied to reference of the subject to risk degree.
In case of identification of one gross violation, to the subject of control the exponent of risk 100 is equated and concerning it preventive control with visit of subject (object) of control is carried out.
If gross violations are not revealed, for measure definition of risk degree the total indicator on violations of considerable and insignificant degree is calculated.
In case of measure definition of considerable violations the coefficient of 0,7 is applied and this indicator is calculated by the following formula:
SRZ = (SP2 x 100/SP1) x 0,7
where:
SRZ – indicator of considerable violations;
SP1 – the required number of considerable violations;
SP2 - the number of the revealed considerable violations.
In case of measure definition of insignificant violations the coefficient of 0,3 is applied and this indicator is calculated by the following formula:
SRN = (SP2 x 100/SP1) x 0,3
where:
SRN – indicator of insignificant violations;
SP1 – the required number of insignificant violations;
SP2 – the number of the revealed insignificant violations.
The general exponent of risk (SP) is calculated on scale from 0 to 100 and is determined by summing of indicators of considerable and insignificant violations by the following formula:
SP = SRZ + SRN
where:
SP - general exponent of risk;
SRZ - indicator of considerable violations;
SRN - indicator of insignificant violations.
22. On general exponent of risk the subject (object) of control belongs:
1) to high risk – in case of exponent of risk from 61 to 100 inclusive and concerning it preventive control with visit of subject (object) of control is carried out;
2) not carried to high risk – in case of exponent of risk from 0 to 60 inclusive and concerning it preventive control with visit of subject (object) of control is not carried out.
23. Frequency rate of carrying out preventive control with visit of subject (object) of control is determined by results of the carried-out analysis and assessment of the received data on subjective criteria and is not more often than once a year.
24. Preventive control with visit of subject (object) of control are carried out based on the semi-annual lists of preventive control with visit of subject (object) of control created according to Item 3 of article 141 of the Entrepreneurial code of the Republic of Kazakhstan.
25. The basis for purpose of preventive control with visit of subject (object) of control is the semi-annual list of carrying out preventive control with visit of subject (object) of control approved by the first head of regulatory state agency.
26. Semi-annual lists of carrying out preventive control with visit of subject (object) of control are created concerning subjects of control with obligatory specifying of objects concerning which preventive control with visit of subject (object) of control is appointed.
27. Lists of preventive control with visit of subject (object) of control are constituted taking into account priority of the subject of control with the greatest exponent of risk by subjective criteria.
to Criteria for evaluation of risk degree in the field of quality of rendering medical services (help)
Subjective criteria for evaluation of risk degree concerning checks on special procedure with distribution on degree of the importance of violations and sources of information
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№ of payment order |
Name of criteria |
Extent of violations |
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1. Criteria on information source "Results of the previous checks and special procedure for conducting checks (severity is established in case of non-compliance with following requirements) | ||
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Criterion for the objects of obstetric aid and (or) the stationary organizations incorporating delivery rooms and departments of pathology of newborns | ||
|
1. |
Availability of the license and appendices to it on the performed types of activity |
rough |
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2. |
Availability of the certificate of the specialist in the corresponding clinical specialty |
rough |
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3. |
Availability of the conclusion about compliance of the subject of health care to provision of high-technology medical services |
rough |
|
4. |
Availability of written voluntary consent of the patient or his legal representative in case of invasive interventions and on holding medical and diagnostic actions |
considerable |
|
5. |
Time of stay of crew of SSMP or department SMP under the PHC organization in reception of hospital does not exceed 10 minutes (time for transfer of the patient to the doctor of reception) from the moment of its arrival in hospital, except as specified need of rendering emergency medical service for emergency situations. |
rough |
|
6. |
In the absence of indications for hospitalization in the organization of health care, the doctor of reception issues to the patient the medical certificate with written reasons for refusal. |
considerable |
|
7. |
Availability of indications for hospitalization: |
considerable |
|
8. |
Survey of the patient by the manager of department of heavy patients in day of hospitalization, in subsequent – daily. The patients who are in medium-weight condition are inspected at least once a week. Results of survey of the patient are registered in the medical record with indication of recommendations about further tactics of maintaining the patient with obligatory identification of the health worker making records |
considerable |
|
9. |
Daily survey of the patients who are in hospital, the attending physician except days off and holidays. In case of survey and appointment of additional diagnostic and medical manipulations as the doctor on duty the corresponding entries in the medical record are carried out |
considerable |
|
10. |
Additional and repeated carrying out the researches conducted before hospitalization in the PHC organization or other organization of health care on medical indications, with reasons in the medical record for dynamic assessment of condition of the patient, according to clinical protocols of diagnostics and treatment. |
considerable |
|
11. |
Observance of the following requirements in case of issue of leaf and certificate of temporary disability for pregnancy and childbirth: |
considerable |
|
12. |
Availability of carrying out clinical audit by Support service of the patient and internal examination and its assessment by the following criteria: |
considerable |
|
13. |
Availability of the informed voluntary consent (refusal) to transfusion of components of blood in form of accounting and reporting documentation in the field of health care |
considerable |
|
14. |
Observance of the following actions when carrying out pathoanatomical opening: |
rough |
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