ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of May 18, 2017 No. 309

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 for No. 10735, it is published in information system of law of Ad_let on April 24, 2015) 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:

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 official Internet resource of the Ministry of Health of the Republic of Kazakhstan;

4) within ten calendar 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 ten calendar days after day of its first official publication.

Appendix

to the Order of the Minister of Health of the Republic of Kazakhstan of May 18, 2017 No. 309

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 Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" (further - the Code) and establish procedure for carrying out accreditation in the field of health care.

2. In these rules the following concepts are used:

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

2) the preaccreditation period - preparatory activities to the procedure of accreditation which is carried out by the medical organization;

3) the commission on accreditation - the commission created by authorized body or the accrediting organization which considers the applicant's materials carries out assessment on compliance of their activities to requirements;

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

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

6) prolongation of effective period of the certificate on accreditation - the official procedure of prolongation of effective period of the certificate on accreditation by accrediting body;

7) 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 the accomplishment of accreditation standards approved by the Order of the Minister of Health of the Republic of Kazakhstan of October 2, 2012 No. 676, registered in the Register of state registration of regulatory legal acts of the Republic of Kazakhstan for No. 8064;

8) accrediting body - authorized body or the organization accredited by authorized body, performing accreditation in the field of health care;

9) the certificate on accreditation of the accrediting organization - the official document confirming accreditation of the accrediting organization;

10) accreditation on the right of carrying out preclinical (not clinical) researches of biologically active agents, products of medical appointment - the procedure of official recognition by accrediting body of activities of the applicant to perform works in the field of carrying out preclinical (not clinical) researches of biologically active agents, products of medical appointment of evaluating test laboratories as way (research laboratory) to compliance of their activities to the procedure provided by Chapter 5 of these rules;

11) the applicant on accreditation on the right of carrying out preclinical (not clinical) researches of biologically active agents, products of medical appointment - the test laboratory (research laboratory) which is performing preclinical (not clinical) researches and submitted the application for accreditation;

12) the organization for assessment of professional readiness and confirmation of conformity of qualification of specialists in the field of health care - the organization of health care the performing activities for assessment of professional readiness and confirmation of conformity of qualification of specialists in the field of health care (further - the organization for assessment);

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

14) clinical base - the medical organization determined by authorized body, performing performing clinical trials based on the recommendation of the expert organization;

15) clinical trial - the research with participation of the person as the subject conducted for identification or confirmation of safety and efficiency of means, methods and technologies of prevention, diagnostics and treatment of diseases;

16) the register of clinical bases - single base of accounting of the medical organizations accredited on the right of performing clinical trials pharmacological and medicines, products of medical appointment and medical equipment;

17) the register of preclinical (not clinical) bases - single base of accounting of the test laboratories accredited on the right of carrying out preclinical (not clinical) researches of biologically active agents pharmacological, medicines, products of medical appointment and medical equipment;

18) multicenter clinical trial - clinical trial which is performed in several clinical bases (more than one researcher) under the single protocol;

19) repeated accreditation (re-accreditation) - another procedure of official recognition by authorized body or accrediting organization of activities of the applicant (for carrying out scientific works) to perform works in certain area of researches (as clinical base) or re-accreditation of the medical organization on compliance to accreditation standards after effective period of the certificate on accreditation or in case of amendment new types and in amounts of the rendered services;

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

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

22) accreditation of the medical organizations on the right of performing clinical trials pharmacological and medicines, products of medical appointment and medical equipment - the procedure of official recognition by the accrediting organization for accreditation of competence of the applicant to perform works in the field of performing clinical trials pharmacological and medicines, products of medical appointment and medical equipment;

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

24) 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;

25) 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;

26) preakcreditation - the decision of the Commission on accreditation made in case of discrepancy of results of external complex assessment to requirements of the second, first or highest category of accreditation;

27) the coordinator of quality - the employee of the medical organization who is responsible for coordination of actions for improvement of quality of medical services and safety of the patient, the speaker as the main contact person with the accrediting organization;

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

29) test laboratory (center) - the legal entity performing researches, testing;

30) area of accreditation of test laboratory - the field of activity of test laboratory determined in case of its accreditation, establishing set of works on testing which is competent to carry out laboratory;

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

32) the expert in external complex assessment (further - the Expert) - the specialist of the organization of health care corresponding to the criteria specified in Item 84 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. The doctor, the nurse, the manager can be the expert;

33) 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;

34) the applicant on accreditation on the right of performing clinical trials pharmacological and medicines, products of medical appointment and medical equipment - the medical organization which is applying for accreditation on the right of performing clinical trials pharmacological and medicines, products of medical appointment and medical equipment and submitted the application for accreditation to accrediting body;

35) 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;

36) the international multicenter clinical trial - the multicenter clinical trial conducted under the single protocol in two or more countries;

37) GCP (Good Clinical Practice (Goode Klinikal Praktis - GKP) - proper clinical practice) - the international standard of ethical standards and quality of scientific research describing rules of development, carrying out, maintaining documentation on researches which imply participation of the person as the examinee;

38) GLP (Good Laboratory Practice (Goode Laboratori Praktis - GLP) - proper laboratory practice) is system of the regulations, rules and instructions aimed at providing coordination and reliability of results of laboratory researches.

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

4. According to article 14 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" (further - the Code) accreditations 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;

3) the medical organizations on the right of performing clinical trials pharmacological and medicines, products of medical appointment and medical equipment;

4) test laboratories on the right of carrying out preclinical (not clinical) researches of biologically active agents, products of medical appointment;

5) test laboratories, performing exclusive activities for examination and estimates of safety and quality of medicines, products of medical appointment.

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

5. Accreditation is performed by authorized body in the cases provided by subitems 1), 3), 4) and 5) of item 4 of these rules; the organization accredited by authorized body in the cases provided by subitems 2) and 6) 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 external complex assessment of the medical organizations on compliance to Accreditation standards and post-accreditation monitoring (further - the Organization) is subject to accreditation by authorized body for implementation of accreditation of the medical organizations.

7. Accreditation of the Organization is carried out in the presence of the following documents:

1) statements on accreditation as the accrediting organization for form according to appendix 1 to these rules;

2) the results of self-assessment on compliance to accreditation standards of the accrediting organization specified in appendix 2 to these rules, conducted by the Organization independently or with involvement of consultants (physical persons or legal entities for preparation for accreditation);

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

4) copies of provision and (or) articles of organization which activities include functions on carrying out external complex assessment of the medical organizations on compliance to Accreditation standards;

5) the list of the employees involved in activities for accreditation and copies of the employment contracts with them confirming work experience at least three years on development, training, implementation, monitoring of accreditation standards at national and (or) international level;

6) copies of the approved business plan or the strategic plan confirming planning of activities in the field of accreditation of the medical organizations;

7) the list of experts in external complex assessment including at least 100 experts in external complex assessment corresponding to criteria according to Item 84 of these rules with indication of surname, name, middle name (in the presence), contact information, data on training in questions of accreditation with application of copies of agreements on participation in accreditation;

8) the estimative sheets (in any form) used in carrying out to external complex assessment;

9) copies of the international certificate about accreditation as the accrediting organization (The organization on external complex assessment);

10) copies of the international certificate about accreditation of the training program of experts in external complex assessment and the copy of educational and methodical materials on training of experts and (or) the medical organizations for accreditation.

8. The organization sends the documents listed in Item 7 of these rules to OKK.

The secretary of OKK within one working day in cases of provision of incomplete document package and (or) documents with the expired effective period, refuses reception of an application.

9. OKK makes the positive decision on accreditation of the Organization by complete provision of the documents specified in Item 7.

Based on the decision OKK, authorized body issues the order no later than fifteen calendar days from the date of registration of a statement of the Organization on accreditation passing.

10. The certificate on accreditation of the Organization is granted according to appendix 3 to these rules for a period of five years during which action the authorized body does not carry out accreditation of other organizations.

11. The authorized body withdraws the certificate on accreditation of the Organization in the presence of the decision (sentence) of court on prohibition of activities or separate types of activity which took legal effect.

12. In cases of change of the name of the Organization, within five calendar days from the date of filing of application the authorized body renews the certificate on the Organization.

The certificate on accreditation granted earlier returns to authorized body.

13. The withdrawal of the certificate on accreditation of the Organization, is performed in case of loss (spoil) of the certificate on accreditation during its action based on the written application in any form of the Organization within five calendar days from the date of receipt of the statement provides the duplicate.

Chapter 3. Procedure for accreditation of the subject of the health care performing assessment of professional readiness and confirmation of conformity of qualification of specialists in the field of health care

14. The organization for assessment of professional readiness and confirmation of conformity of qualification of specialists in the field of health care (further - the organization for assessment) for passing of accreditation submits the following documents to authorized body:

1) the statement in form according to appendix 4 to these rules;

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

3) copies of the documents confirming availability of the room or building on the property right or the lease contracts certified notarially;

4) copies of the documents confirming the information about personnel of the organization accredited on implementation of activities for assessment of professional readiness and confirmation of conformity of qualification of specialists in the field of health care in form according to appendix 5 to these rules;

5) copies of the documents constituting methodology of the organization for assessment: the strategic plan of development, the list of examination material (bank of test tasks and clinical scenarios) for carrying out independent assessment of specialists of health care and graduates of the organizations of medical education and science;

6) the list of the simulyatsionny and medical equipment of the organization accredited on implementation of activities for assessment of professional readiness and confirmation of conformity of qualification of specialists in the field of health care by assessment in form according to appendix 6 to these rules.

15. OKK considers documents within one working day from the date of receipt of documents regarding completeness and reliability of filling.

16. In case of provision of incomplete document package, stipulated in Item 14 and (or) documents with the expired effective period, OKK refuses reception of an application.

17. By complete provision of documents OKK also confirmation of conformity of qualification of specialists in the field of health care according to appendix 7 to these rules carries out complex assessment on compliance of its activities to the established Accreditation standards for the organization for assessment of professional readiness.

18. Complex assessment of the organization for assessment on compliance to accreditation standards consists of the following stages:

1) self-assessments on compliance to accreditation standards by filling of sheets of assessment conducted independently;

2) examinations of the documents submitted for passing of the procedure of the accreditation which is carried out by accrediting body;

3) expert evaluation of compliance to accreditation standards by filling of sheets of assessment with departure in the organization for assessment;

4) assessments of conformity of the organization for assessment to accreditation standards on the basis of rating scale (points) of compliance to requirements of accreditation standards according to appendix 8 to these rules (further - scale).

19. Assessment of conformity to accreditation standards is carried out on the basis of the ball system including points from 0 to 2. The mark scale allows to estimate the measured criterion of organization activity by assessment.

20. According to each standard average assessment is calculated: score by criteria of the standard, divided into amount of criteria in the standard, that is Average assessment according to the standard = k1+k2+k3+k4+k5/C, where k 1, k 2, k 3, k 4, k5 - points by criteria of standards, With - amount of criteria in the standard.

21. Data are entered in the final table of estimates (points) of compliance to requirements of Accreditation standards according to appendix 9 to these rules.

22. Based on the analysis of the conducted research each criterion of the standard is estimated on the specified scale.

23. Objectivity of assessment of conformity and reliability of calculation of points for each standard make sure the signature of members of OKK.

24. Based on the solution of OKK the order of authorized body, no later than fifteen working days from the date of registration of a statement on accreditation passing is issued.

25. The certificate on accreditation of the organization for assessment of professional readiness and to confirmation of conformity of qualification of specialists in the field of health care is issued according to appendix 10 to these rules for a period of five years during which action the authorized body does not carry out accreditation of other organizations.

26. In accreditation of the organization for assessment refuses in the following cases:

1) availability in the submitted documents of unreliable information;

2) discrepancies of the organization for assessment to accreditation standards;

3) the judgment which took legal effect about prohibition on occupation activities for the declared type.

Chapter 4. Procedure for accreditation of the medical organizations on the right of performing clinical trials pharmacological and medicines, products of medical appointment and medical equipment

27. Accreditation of the medical organizations on the right of performing clinical trials pharmacological and medicines, products of medical appointment and medical equipment is performed for the purpose of recognition of activities of the medical organization on carrying out the following types of clinical trials pharmacological and medicines, products of medical appointment and medical equipment:

1) clinical trials of medicines (1-4 phases);

2) researches of bioequivalent medicines;

3) clinical researches / testing of products of medical appointment and medical equipment;

4) multicenter clinical trials;

5) the international multicenter clinical trials according to requirements of these rules.

Accreditation of the medical organizations is carried out as concerning all the types specified in this Item, and concerning one of them.

28. Accreditation of the medical organizations on the right of performing clinical trials pharmacological and medicines, products of medical appointment and medical equipment is carried out on the basis of assessment on compliance of their activities to the requirements for performing clinical trials established by these rules.

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