Laboratory medicine: there is a draft regulation on personnel and medical laboratory qualifications

The need to define new requirements to be met by the premises and equipment of a medical diagnostic laboratory in connection with the entry into force of the Law of September 15, 2022 on laboratory medicine regulating laboratory medicine.

The proposed regulation is expected to improve the quality and reliability of laboratory test results, thereby improving treatment outcomes and, indirectly, the health of the public.

The proposed regulation indicates that the premises of the laboratory should be adapted to the type of work that is performed in them, in such a way as to ensure the correct quality of measurements and the reliability of the results. The types of rooms that make up the laboratory are listed, divided into the main room, social room, patient service room and administrative room. The appendix specifies the list of professional qualifications for each job in the laboratory.

In the draft regulation:

1) Nomenclature was adjusted in accordance with the provisions of the Law of September 15, 2022 on laboratory medicine;

2) positions and qualifications have been brought into line with the provisions of the Regulation of the Minister of Health of July 10, 2023, on the qualifications required of employees in particular types of jobs in nonenterprise medical entities;

3) With regard to the job position of junior laboratory medicine assistant, pursuant to Article 5 (1) (3) of the Law of September 15, 2022 on laboratory medicine, persons who have completed a single master's degree or first and second degree studies in the field are included:

(a) biology, medical biology, microbiology or medical microbiology and has obtained a professional degree of Master's degree or

(b) biotechnology or medical biotechnology and obtained a professional degree of Master of Science or Master of Engineering.

4) the requirements for the laboratory manager in terms of professional qualifications in accordance with the provisions of the aforementioned law are specified.

It is also proposed that the manager can be a person who has 5 years of experience in working in the laboratory, which will prevent people with only theoretical knowledge without experience of working in the profession from performing this function.A transitional provision has also been proposed according to which an entity that performs therapeutic activities, in the field of laboratory medicine, and a university that operates a laboratory will be able to adjust its activities to the qualification requirements for individual positions within 2 years from the date of entry into force of this regulation. The introduction of the transitional provision will allow those who do not meet the requirements for particular positions as of the effective date of the regulation's provisions to maintain continuity of practice.

Source: RCL