The Regulation on Medical Laboratories, published by the Ministry of Health in the Official Gazette dated June 4, 2024, and numbered 32566, sets new procedures and principles for the regulation of medical laboratory services.
Purpose and Scope of the Regulation: The regulation aims to establish procedures and principles for the planning, opening, classification, supervision, and standardization of medical laboratory services. It covers health facilities belonging to the Ministry of Health, universities, private health institutions, and independent medical laboratories.
Formation and Duties of the Commission: A scientific commission has been established to improve the quality and development of medical laboratories. The commission is responsible for setting minimum and quality standards for medical laboratories and providing scientific opinions.
Classification of Laboratories: Laboratories are divided into four main units: medical biochemistry, medical microbiology, medical pathology, and tissue typing laboratories. Additionally, they are classified based on service content as supervised, comprehensive, regional laboratories, test-based reference-authorized, and national reference laboratories.
Application and Licensing Process: Medical laboratories can operate with a license and operating permit issued by the Ministry of Health. Applications are made to the Provincial Health Directorate with the necessary documents and approved by the Ministry.
Working Principles: Medical laboratories will provide services for at least eight hours in compliance with current scientific and technological requirements. Tissue typing laboratories will operate 24/7. Services must be carried out in accordance with ethical and evidence-based medical principles.
Personnel Regulations: Qualified personnel in the relevant specialty field must be employed in laboratories. A medical laboratory specialist will be appointed as the unit manager in each laboratory. In private health institutions, medical laboratory specialists can work in more than one facility under certain conditions.
Inspection and Sanctions: Laboratories will be regularly inspected according to established procedures and principles, and sanctions will be applied if non-compliance is detected. Licenses and permits can be revoked in certain situations.
Safety and Waste Management: Safety measures and waste management are critical in medical laboratories. Physical, chemical, and biological safety measures must be taken, and waste must be disposed of in accordance with regulations.
Source: Official Gazette
