Law no. 185/2017 about quality assurance in the health system

1. Overview
Law no. 185/2017 addresses quality assurance in the health system. It regulates the quality management standards of health services provided at the national level.
The standardization and evaluation of health services are carried out by the National Authority for Quality Management in Health (NAQMH).
The essential features of NAQMH are the following:

• NAQMH is a public institution with a legal personality. It is a specialized body of the central public administration in the field of health quality management, and it operates under the control of the Government and the coordination of the Prime Minister. Its headquarters are in Bucharest.
• NAQMH holds the authority for standardization and impartial evaluation of health services, accreditation, and monitoring of healthcare providers regardless of stakeholders.
• NAQMH is funded from its own revenues and subsidies from the public budget. The income earned from accreditation activities is considered its own revenue.
The purpose of NAQMH is to ensure and continuously improve the quality of health services and patient safety by standardizing and evaluating health services and accrediting healthcare providers.
To attain its objectives, NAQMH holds extensive responsibilities, amongst which the most important are:

• the participation, in collaboration with the Ministry of Health, in implementing the National Strategy for Quality Assurance in the Health System;
• proposing to the Ministry of Health and Government draft laws that enact national legislation about quality assurance in health services in the health system and that adopt international regulations in the field;
• recognizing, according to methodology approved by NAQMH President’s Order, the quality of health services advisory service providers and training personnel specializing in health services quality management;
• Evaluating, assessing, accrediting, and re-accrediting health care providers and monitoring the quality assurance of health services at their level;
• Issuing or withdrawing an accreditation certificate of the healthcare providers according to the conditions approved by the resolution of the Managing Board;
2. The accreditation procedure
Healthcare providers are registered in the accreditation process by submitting documentation to NAQMH accompanied by the proof of payment of the accreditation fee under the conditions established by the resolution of the NAQMH Managing Board.

a. Submitting documentation to NAQMH
The methodology, deadlines, and conditions for the enrolment of healthcare providers in their accreditation process and their planning in the evaluation process for accreditation are approved by the resolution of the NAQMH Managing Board.
The accreditation lasts five years then must be renewed.
Accreditation is a mandatory requirement for healthcare providers that provide services in the public health insurance system.

b. Other relevant provisions
The accreditation categories of the healthcare providers are approved by the NAQMH Managing Board after receiving Ministry of Health approval.
The validity of the accreditation certificate obtained following the reaccreditation process cannot exceed the period of validity of the original accreditation certificate

3. Organization and leadership
The governing bodies are represented by:

• Managing Board;
• Permanent Office of the Managing Board;
• President of NAQMH;
• CEO (Chief Executive Officer).

a. NAQMH Managing Board
The NAQMH Managing Board is the collective leading body of NAQMH and consists of 25 people that represent different authorities, institutions, and organizations.
Member’s appointment
The members of the Managing Board are designated by the authorities, institutions or organizations they represent for five years.

An appointee may not complete a term because of:
• Resignation;
• ca urmare a constatării neîndeplinirii sau îndeplinirii defectuoase a atribuţiilor aferente calităţii de membru, la sesizarea preşedintelui sau a membrilor Colegiului director, adresată autorităţii, instituţiei publice sau organizaţiei care l-a desemnat;
• Termination of the appointment as result of a proven failure in fulfilling or of an inadequate fulfilling of the responsibility of membership;
• The withdrawal of the appointment by the authority, public institution, or organization that has appointed the Appointee in that capacity;
• Other situations provided by law.

If any of these situations occur, the authority, the public institution, or the organization stipulated by the law appoints a new representative up until the end of the five-year period.
The ways of organizing and functioning of the Managing Board are established by its own regulation. Also, in fulfilling its duties, the Managing Board issues resolutions.
The Managing Board meets on a regular basis in regular sessions.

b. Permanent Office of the Managing Board
Member’s appointment

The Permanent Office of the Managing Board consists of seven people, namely the President of the NAQMH, permanent member, as well as six members, chosen by rotation by the Managing Board out of its members, for six months.
Organizing and main attributions
The Permanent Office of the Managing Board meets monthly, between the ordinary meetings of the Managing Board.

c. President of NAQMH

The NAQMH President has the rank of the Secretary of State and is appointed for a five-year mandate, by decision of the Prime Minister. He is also the President of the Managing Board.

Appointment ceasing before deadline:
• Resignation;
• Criminal conviction established by a final court order;
• The inability to perform the legal responsibilities of the President’s office for at least 90 days;
• Death;
• Other situations provided by law.

d. CEO (Chief Executive Officer)
The executive management is the responsibility of a CEO appointed by the President of NAQMH based on merit.

The qualifications for CEO include:

• Long-term higher education in the medical, legal, or economic field;
• Masters in health management or specialization in health services quality management;
• Compliance with legal provisions about conflicts of interest and incompatible office.
Main duties
The duties of the CEO for the executive management of NAQMH are established by the regulations on the organization and functioning of NAQMH.

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