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Lawyer’s consultation in the question-answer format for the “Laboratornoe delo” (“Laboratory business”) magazine

Volodymyr Misyurak, a lawyer at Pravova Dopomoga Law Firm, answers readers’ questions

Does a biologist specializing in Clinical Laboratory Diagnostics have the right to work as a medical laboratory scientist in a clinical laboratory?

According to the Order of the Ministry of Health of Ukraine “Guide on Qualification Characteristics of Professions. Issue 78 “Healthcare” No. 117 of 29.03.2002, a medical laboratory scientist shall meet the following educational and qualification requirements:

  • To have higher education (specialist, master degree) in Medicine;
  • To be majored in one of the medical specialties;
  • To complete internship training in Laboratory diagnostics with further specialization in Clinical laboratory diagnostics;
  • To have a medical specialist certificate.
Since a biologist (a laboratory technician with non-medical education) does not meet these characteristics, he/she cannot work as a medical laboratory scientist.

However, given the provisions of the Order of the Ministry of Health of Ukraine “On certification of specialists with higher non-medical education working in the health care system” No. 588 of 12.08.2009 (hereinafter - the Order No. 588) and a number of other regulatory acts, if a biologist (a laboratory technician with non-medical education) successfully completes an accredited science program in Clinical Laboratory Diagnostics, he/she can provide the same range of health care services as a medical laboratory scientist.

It is also worth noting that a biologist is a person with higher education (except for pedagogical education) in Biology, who was admitted to medical practice as a medical laboratory scientist thanks to the Order of the Ministry of Health of Ukraine “On Approval of the List of Higher and Secondary Specialized Educational Establishments, training and obtaining the title of which give the right to engage in medical and pharmaceutical activities” No. 195 of 25.12.1992 (hereinafter - the Order № 195), and such a person has the right to work as a medical laboratory scientist. In this view, a person shall be appointed to the medical position before 12.10.2009, which is the effective date of the Order No. 588, which approves a new procedure for certification of specialists with higher non-medical education working in the healthcare system, and provides for a new nomenclature of specialties. Such specialists, being engaged for medical positions in health care facilities prior to  the Order No. 588 coming into force, retain the right to further work in medical positions of the same title and certification for the qualification category in medical specialties.

Shall a health care facility own a clinical and diagnostic laboratory, and shall it employ a medical laboratory scientist or it may hire only a biologist in order to obtain a Medical License?

Resolution of the Cabinet of Ministers of Ukraine No. 285 of March 2, 2016, which approves the Licensing Regulations for carrying on medical activities (hereinafter - the Licensing Regulations) stipulates that the Clinical and Diagnostic Laboratory (CDL) is a structural unit of the health care facility that carries out medical activities. This means that in terms of licensing, CDL shall be owned by a health care facility and should be duly reflected in the statement on the availability of material and technical basis and qualification of personnel.

In turn, the issue if choosing between a biologist and a medical laboratory scientist should be considered from two perspectives. If you intend to obtain a license for the Clinical Laboratory Diagnostics specialty, it is quite enough to have a biologist on a payroll, who has a valid specialization in this field. This is confirmed by para. 27 of the Licensing Regulations and a number of paragraphs of the Order No. 588. But if the staffing chart provides for the position of the head of the laboratory, such a position can be held by either a medical laboratory scientist or a person with biological education admitted to work in accordance with the Order No. 588 and Order No. 195.

It should be noted that although there is a legal grounds for the professionals with biological education taking duties of the head of the laboratory, in practice, the licensees may face a number of difficulties that can prevent them from obtaining a Medical License.

Can a biologist be the head of a laboratory in a health care facility and what requirements shall be met in accordance with the licensing regulations?

Clinical and diagnostic laboratory is considered to be a subdivision of a health care facility and carries out medical activities. Educational qualification requirements to the heads of structural subdivisions of the health care facilities are determined by the Order of the Ministry of Health of Ukraine “Guide on Qualification Characteristics of Professions. Issue 78 “Healthcare” No. 117 of 29.03.2002, which, in particular, sets forth the following qualification requirements to the heads of laboratory:

  • They shall have higher education (specialist, master degree) in Medicine;
  • They shall complete internship training in one of the medical specialties with further specialization in a structural subdivision area of expertise;
  • They shall undergo advanced training (postgraduate training, internships, pre-certification courses, etc.);
  • They shall have medical specialist certificate and a certificate of assignment (confirmation) of a qualification category in this specialty.

Biologists are specialists with non-medical education, and therefore they do not meet the requirements for the position of the head of the laboratory.

However, a biologist is a specialist with biological education, who was duly admitted to medical practice (as a medical laboratory scientist) in accordance with the Order of the Ministry of Health of Ukraine “On Approval of the List of Higher and Secondary Specialized Educational Establishments, training and obtaining the title of which give the right to engage in medical and pharmaceutical activities” No. 195 of 25.12.1992, and prior to the entry into force of the Order of the Ministry of Health of Ukraine “On certification of specialists with higher non-medical education working in the health care system” No. 588 of 12.08.2009, had at least 5 years of work experience as a laboratory assistant and held the position of the head of the laboratory, may continue to hold the position of the head of the laboratory department of the health care facility.

Today, we can see that biologists often perform the duties of the head of laboratory departments. However, such staffing of the position does not actually meet the requirements of the current legislation, as often indicated by the Ministry of Health of Ukraine and local health departments.

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