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LAW OF THE REPUBLIC OF MOLDOVA

of October 18, 2001 No. 552-XV

About assessment and accreditation in health care system

(as amended on 16-12-2020)

The parliament adopts this organic law.

Assessment and accreditation in health care system is performed for determination based on the standards developed and approved by the Ministry of Health, work and social protection, capability of suppliers of medical and pharmaceutical services irrespective of type of their property, form of business and departmental accessory, to give to the population appropriate assistance and to carry out the tasks provided by the Law on health protection No. 411-XIII of March 28, 1995, the Law of rights and responsibility of the patient of N263-XVI of October 27, 2005, the Law on profession of a physician of N264-XVI of October 27, 2005, the Law on pharmaceutical activities No. 1456-XII of May 25, 1993, the Law on the state supervision of public health No. 10/2009, the Law on compulsory medical insurance No. 1585-XIII of February 27, 1998, the Marine life protection act of the rights of consumers No. 1453-XII of May 25, 1993 other regulations in the field of medicine and pharmacy.

Main goal of assessment and accreditation in health care system is improvement of quality of the services provided by suppliers of medical and pharmaceutical services to the population.

Chapter I General provisions

Article 1. Subject of the law

This law establishes the basic principles and evaluation procedure and accreditations of suppliers of medical and pharmaceutical services.

Article 2. Basic concepts

In this law the following basic concepts are used:

accreditation - the procedure by means of which the responsible body for assessment and accreditation in health care system in official procedure recognizes that they the supplier of medical or pharmaceutical services, its personnel are competent to perform specific activities for the profile according to standards and provisions of the laws in the field of medicine and pharmacy;

assessment - the central stage of the procedure of the accreditation performed by responsible body for assessment and accreditation in the field of health care, providing assessment of conformity of activities of suppliers of medical and pharmaceutical services to standards in the field;

the current assessment - the independent and systematically carried out assessment of activities of accredited suppliers of medical and pharmaceutical services for the purpose of determination of compliance of the services rendered by them to the regulatory base in the field of health care;

the expert-appraiser in health care system - the physical person who is the highly qualified specialist in the field of medicine and pharmacy, selected by responsible for assessment and accreditation body in health care system according to the established criteria and attracted from the outside of relevant organ to assessment of conformity to standards of assessment and the accreditation provided by suppliers of medical and pharmaceutical services;

the certificate on accreditation - the document issued according to the rules existing in national system of assessment and accreditation of organizations and companies of health care, testimonial of sufficient degree of compliance of the supplier of medical or pharmaceutical services to provisions of the laws in the field of health care and pharmacy;

the register of certificates on accreditation – set of documentary information on the issued, renewed, suspended and withdrawn certificates on the accreditation which is stored in manual and/or the automated information systems organized according to the current legislation;

The register of experts-appraisers in health care system - set of the documentary information which is stored in the manual and/or automated information systems on the experts-appraisers in health care system recognized by National council by assessment and accreditation in health care system;

withdrawal of the certificate on accreditation - deprivation of the owner of the certificate on accreditation of the right of implementation of medical and pharmaceutical activities according to the procedure provided by the current legislation;

the applicant of the certificate on accreditation - the legal entity or physical person registered in accordance with the established procedure in the Republic of Moldova as the company or the organization irrespective of property type which intends to be engaged or is engaged in medical and/or pharmaceutical activities and submits the application for activities assessment to the body responsible for assessment and accreditation in health care system;

standards of assessment and accreditation - set of legislative provisions and regulations in the field of health care and other areas regulating activities of the organization/company and influencing quality of medical and pharmaceutical services;

suspension of the certificate on accreditation - deprivation of the owner of the certificate on accreditation of the right of implementation of medical and pharmaceutical activities for the term established by this law.

Article 3. Main principles of assessment and accreditation of suppliers of medical and pharmaceutical services

(1) treat the main principles of assessment and accreditation of suppliers of medical and pharmaceutical services:

a) transparency and publicity;

b) representation of public concerns and independence of any other interests;

c) ensuring confidentiality of information obtained in the course of assessment and accreditation;

d) application of the standards existing in the field of medicine and pharmacy;

e) observance of requirements of the relevant international acts;

e-1) non-commercial (non-profitable) nature of activities;

f) ceased to be valid;

g) possibility of appeal of the decision made as a result of assessment of organization and the company.

(2) In the Republic of Moldova has the right to be engaged in medical and pharmaceutical activities only those suppliers of medical and pharmaceutical services which passed assessment and accreditation according to the procedure, established by this law.

Chapter II Evaluation criteria and accreditations of suppliers of medical and pharmaceutical services

Article 4. General criterions

Criteria and requirements imposed to suppliers of medical and pharmaceutical services in case of their assessment and accreditation concern:

a) material and technical resources;

b) financial and economic activities;

c) professionalism of medical and pharmaceutical personnel;

d) compliance of quality of medical and pharmaceutical services, efficiency of medical and diagnostic process and pharmaceutical activities to standards in the field of medicine and pharmacy.

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