I.O'S ORDER. MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of March 14, 2019 No. KR DSM-8

About modification of the order of the Minister of health and social development of the Republic of Kazakhstan of March 10, 2015 No. 127 "About approval of Rules of accreditation of health care"

According to the subitem 76) of Item 1 of article 7 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" I ORDER:

1. Bring in the order of the Minister of health and social development of the Republic of Kazakhstan of March 10, 2015 No. 127 "About approval of Rules of accreditation of health care" (it is registered in the Register of state registration of regulatory legal acts at No. 10735, it is published on April 24, 2015 in information system of law of Ad_let) the following change:

The rules of accreditation of health care approved by the specified order to be reworded as follows according to appendix to this order.

2. To provide to committee of protection of public health 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 order in the Ministry of Justice of the Republic of Kazakhstan;

2) within ten calendar days from the date of state registration of this order the direction it the copy in paper and electronic type in the Kazakh and Russian languages in the Republican state company on the right of economic maintaining "The republican center of legal information" for official publication and inclusion in Reference control bank of regulatory legal acts of the Republic of Kazakhstan;

3) placement of this order on Internet resource of the Ministry of Health of the Republic of Kazakhstan after its official publication;

4) within ten working days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan submission to Department of legal service of the Ministry of Health of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1), 2) and 3) of this Item.

3. To impose control of execution of this order on the supervising vice-Minister of Health of the Republic of Kazakhstan.

4. This order becomes effective after twenty one calendar days after day of their first official publication.

Appendix

to the Order of the acting minister of health care of the Republic of Kazakhstan of March 14, 2019 No. KR DSM - 8

Approved by the Order of the Minister of health and social development of the Republic of Kazakhstan of March 10, 2015 No. 127

Rules of accreditation of health care

Chapter 1. General provisions

1. These rules of accreditation in the field of health care (further - Rules) are developed according to the subitem 76) of Item 1 of article 7 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" (further - the Code) and determine procedure for accreditation in the field of health care.

2. In these rules the following basic concepts are used:

1) accreditation - the procedure of official recognition by accrediting body of competence of the applicant to perform works in certain area of assessment of conformity;

2) the commission on accreditation - the commission created by accrediting body which considers results of external complex assessment of the medical organizations and makes recommendations about their accreditation on activities compliance to requirements of accreditation standards;

3) accreditation standard rank - standard level depending on the importance of its influence on safety of patients;

4) the certificate on accreditation - the official document confirming accreditation of the applicant in certain area of accreditation;

5) post-accreditation monitoring - accreditation stage from the date of receipt of the status of accreditation to the following external complex assessment which purpose is maintenance of accomplishment of the accreditation standards approved by the order of the Minister of Health of the Republic of Kazakhstan of October 2, 2012 No. 676 (it is registered in the Register of state registration of regulatory legal acts at No. 8064);

6) accrediting body - department of authorized body (further - department) or the organization accredited by department, performing accreditation in the field of health care;

7) the observer - the applicant for the subsequent attraction by accrediting body as the expert in external complex assessment after three or more observations without assessment right on points when carrying out external complex assessment;

8) subjects of health care - the organizations of health care, and also the physical persons practising private medicine and pharmaceutical activities;

9) the subcontract organization - the legal entity involved by the medical organization in agreement performance of the contract;

10) the medical organization - the organization of health care which main activities is delivery of health care;

11) conflict of interest - situation in case of which personal interest of the expert influences results of external complex assessment of the medical organization;

12) the joint commission on quality of medical services (further - OKK) - the advisory advisory body under authorized body created for development of recommendations about enhancement of clinical protocols, standards of medical education, provision of medicines, standards of quality control system and availability of services in the field of health care;

13) self-assessment - the assessment procedure of activities of the medical organization on compliance to accreditation standards conducted by the medical organization independently or with involvement of independent experts;

14) expert group - the group of persons attracted to carrying out external complex assessment of the medical organization on compliance to accreditation standards;

15) external complex assessment - the assessment procedure of activities of the medical organization on compliance to accreditation standards which is carried out by expert group with exit in the medical organization;

16) the expert in external complex assessment - the specialist of the organization of health care corresponding to the criteria specified in Item 37 of these rules, involved to carrying out external complex assessment of the medical organizations on compliance to accreditation standards as a part of expert group.

17) Committee on accreditation and quality management of medical services OKK (further - Committee) - the permanent division of OKK created for development of the offer on the specific problems and questions carried to their competence;

18) treyser - purposeful tracing of different stages of delivery of health care to the patient (the patient's route) or assessment of the processes of system connected among themselves in which employees from different divisions of the medical organization are involved;

19) focal assessment - assessment of the medical organization based on the analysis of documents and (or) visits of the medical organization which is carried out for the purpose of confirmation or refining of results of earlier carried out external complex assessment in cases of doubt in reliability of results of external complex assessment, or in case of the situation subjecting safety of the patient, personnel and visitors to risk of which the accrediting body knew.

3. The body (organization) performing (performing) accreditation in the field of health care creates the relevant commissions on accreditation and creates databank of accredited subjects in the field of health care.

4. According to article 14 of the Code of accreditation in the field of health care are subject:

1) the subjects of health care performing accreditation of the medical organizations for the purpose of recognition of compliance of the rendered medical services to the established requirements and standards in the field of health care;

2) the subjects of health care performing assessment of professional readiness and confirmation of conformity of qualification of specialists in the field of health care, estimates of research and educational personnel of the scientific organizations and organizations of education in the field of health care and assessment of knowledge and skills of students of programs of medical education;

3) the medical organizations on the basis of external complex assessment on compliance of their activities to accreditation standards.

5. Accreditation is performed by department in the cases provided by subitems 1) and 2) of item 4 of these rules, the organization accredited by department in the case provided by the subitem 3) of item 4 of these rules.

Chapter 2. Procedure for accreditation of the subjects of health care performing accreditation of the medical organizations for the purpose of recognition of compliance of the rendered medical services to the established requirements and standards in the field of health care

6. The organization applying for carrying out accreditation of the medical organizations for the purpose of recognition of compliance of the rendered medical services to the established requirements and standards in the field of health care (further - the organization) for passing of accreditation to department submits the following documents:

1) the statement in form according to appendix 1 to these rules;

2) result of self-assessment on compliance to accreditation standards, according to appendix 2 to these rules;

3) copies of the certificate of state registration (re-registration) of the legal entity and (or) branches (representations);

4) copies of provision and (or) charter;

5) the list of the employees involved in activities for accreditation and the copy of the documents according to Article 35 of the Labor code of the Republic of Kazakhstan of November 23, 2015 confirming work experience at least three years in accreditation of the medical organizations at national and (or) international level;

6) the list of experts in external complex assessment in number of at least 100 experts, from which at least 40% with the higher medical education, at least 30% with the higher and (or) secondary medical education in "Nurse business" corresponding to criteria of Item 37 of these rules with indication of surname, name, middle name (in the presence), places of employment, data on training in questions of accreditation and experience in area of accreditation;

7) the copy of the international certificate about accreditation as accrediting body;

8) the copy of the international certificate about accreditation of the training program of experts in external complex assessment (in the presence).

7. In case of complete document package department transfers documents to Committee according to the Rules of forming of the joint commission on quality of medical services and regulations on its activities approved by the order of the Minister of Health of the Republic of Kazakhstan of August 17, 2017 No. 614 (it is registered in the Register of state registration of regulatory legal acts at No. 15671).

The submitted documents are considered by Committee and submitted for OKK meeting for decision making: about approval or refusal in approval of questions of accreditation.

By results of meeting of OKK the protocol is constituted and posted on the website of authorized body.

8. Based on the recommendation of OKK, department no later than fifteen working days from the date of registration of a statement sends to the organization one of the following decisions: issue of the certificate on accreditation, or motivated refusal in issue of the certificate. The decision of department is drawn up in the form of the order.

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