Service Procurement Agreements Under the Medical Laboratory Services Regulation
Introduction
Medical laboratory services are one of the foundational pillars of the healthcare system, providing essential support for protecting human health, preventing disease, enabling accurate diagnosis and monitoring patient treatment. Healthcare facilities are not always able to provide all these services in-house. Factors such as gaps in technical infrastructure, a shortage of specialized personnel, and insufficient capacity for certain tests routinely push healthcare institutions toward procuring laboratory services from outside providers. This practical necessity forms the legal basis for medical laboratory service procurement agreements.
The principal regulatory framework governing such procurement is the Regulation on Medical Laboratory Services and Advanced Technology Medical Laboratory Applications published by the Ministry of Health in the Official Gazette dated 24.10.2025, No. 33057 (“Regulation”).[1] This article examines the parties to medical laboratory service procurement agreements, the conditions under which such agreements are formed and their mandatory content under the Regulation.
The Concept of a Medical Laboratory
Under the Regulation, a medical laboratory is defined as a facility in which biological materials obtained from humans are analyzed for the purposes of assessing health, preventing disease, making a diagnosis, monitoring treatment, and forming a prognosis. The laboratory reports results, interprets them when necessary, and provides recommendations for further investigation. The concept of biological material is broadly defined and encompasses all materials obtained from the human body, including blood, serum, bone marrow, cerebrospinal fluid, bodily and secretory fluids and biopsy specimens.
The Regulation applies broadly to medical laboratories operated by the Ministry of Health, universities, public institutions and organizations, private legal entities and natural persons. The types of laboratory units that may be the subject of service procurement include medical biochemistry, medical microbiology, medical pathology and tissue typing laboratories. An independent medical laboratory refers to a healthcare facility in any of these specialty areas that is established by a natural or legal person and licensed by the Ministry.
Legal Framework for Service Procurement
Article 27 of the Regulation establishes distinct rules for public healthcare facilities, private healthcare facilities, and independent medical laboratories.
Medical laboratories operating within public healthcare facilities may procure services from other public healthcare facilities, from medical laboratories within private healthcare facilities or from independent medical laboratories, all in accordance with Public Procurement Law No. 4734.[2] Public healthcare facilities may also pursue on-site service procurement through a contractor holding a medical device sales authorization. In that case, the contractor must document that it has entered into an agreement with a medical laboratory that holds a license or operating permit for the tests the public healthcare facility does not perform in-house.
Private healthcare facilities providing outpatient or inpatient care may provide services for tests they do not perform in-house from a medical laboratory within another private or public healthcare facility or from an independent medical laboratory. The relevant agreement or protocol must be submitted to the provincial health directorate within fifteen days at the latest.
Independent medical laboratories may procure services from another medical laboratory holding a Ministry license or operating permit, provided a written agreement is in place and only for tests within the specialty areas covered by their own license and for tests in specialty areas not present within their facility.
Mandatory Requirements of the Service Procurement Agreement
When medical laboratory services are provided through procurement, the elements listed in Article 27(6) of the Regulation must be included in the agreement.
Written agreement and allocation of responsibility: An agreement or protocol must be executed between the procuring healthcare facility and the providing healthcare facility. The agreement must clearly identify the parties responsible for each phase of the total testing process. The total testing process covers everything from the entry of the test request into the system through the collection, transfer, laboratory acceptance, analysis, interpretation, and reporting of biological materials.
Reporting: The name and address of the medical laboratory providing, as well as the full name of the medical laboratory specialist who performed the evaluation, must appear in the report, and the report must be signed with an electronic signature. The providing medical laboratory bears primary responsibility for the analysis and the analysis results report following acceptance of the biological material.
Patient notification and fee prohibition: The patient or the patient's family must be informed that the test will be performed at a different medical laboratory. In addition, the procuring healthcare facility may not charge the patient a separate fee for the test.
Transfer of biological materials: Arrangements must be made to send biological materials collected at the requesting healthcare facility to the laboratory from which services are being procured. Where procurement is carried out through a contractor, the contractor is responsible for transferring materials under appropriate conditions and for delivering result reports to the procuring healthcare facility.
Quality oversight: The providing healthcare facility is responsible for monitoring and overseeing quality control processes. The procuring healthcare facility may access the providing facility's quality and control data. A laboratory that provides services to another medical laboratory is also required to notify the procuring healthcare facility of the documents and results from the external quality control program it participates in for tests designated by the Ministry.
Administrative Sanctions
Failure to comply with the obligations governing service procurement gives rise to various administrative sanctions.[3] Where a private healthcare facility fails to submit the service procurement agreement or protocol to the directorate for tests not performed in-house, an administrative fine of no less than one hundred thousand Turkish liras is imposed at a rate of one-thousandth of the facility's gross service revenue for the preceding month, and a thirty-day period is granted for the facility to come into compliance. Where an independent medical laboratory procures services without authorization outside the specialty areas covered by its license, the relevant service is banned from operating by the governor's office, an administrative fine of no less than one hundred thousand Turkish liras is imposed at a rate of one percent of gross service revenue, and a criminal complaint is filed with the public prosecutor's office against the individuals involved.
Conclusion
Medical laboratory service procurement agreements are comprehensively governed by Article 27 of the Regulation and take shape within a multi-layered legal framework that extends well beyond an ordinary private law relationship. For public healthcare facilities, this framework intersects with public procurement law, and for all healthcare facilities, it operates alongside a regime of administrative oversight and sanctions. The core requirements of this framework include a clear allocation of responsibility across all phases of the total testing process, identification of the providing laboratory and the responsible specialist in the report, compliance with the patient notification obligation, and protection of the rights related to quality oversight.
- Regulation on Medical Laboratory Services and Advanced Technology Medical Laboratory Applications, Official Gazette dated October 24, 2025, No. 33057. This Regulation repealed the Medical Laboratories Regulation published in the Official Gazette dated June 4, 2024, No. 32566, and the Genetic Diseases Assessment Centers Regulation published in the Official Gazette dated January 10, 2020, No. 31004.
- Public Procurement Law No. 4734, Official Gazette dated January 22, 2002, No. 24648.
- Regulation on Medical Laboratory Services and Advanced Technology Medical Laboratory Applications, Official Gazette dated October 24, 2025, No. 33057, Annex 16 (Medical Laboratory/Genetic Diseases Diagnosis and Assessment Centers Inspection, Query, and Administrative Sanctions Form).
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