Preparation According to the Medical Laboratory Regulation 2024

Diler Aslan

Following the publication of the Medical Laboratory Regulation 2024 (TLY 2024) (Tuesday, June 4, 2024, Official Gazette, No: 32566), medical laboratories in Türkiye are preparing to renew their licenses. The application deadline is June 4, 2026.

When I started my job as a clinical laboratory manager at a public hospital in 1982, there were no regulations governing clinical/medical laboratories in Türkiye. What we were taught at Boğaziçi University was that, as managers, our primary responsibility was to make all the necessary preparations according to legal regulations.

I have examined clinical laboratory regulations worldwide. I have thoroughly researched the medical laboratory legislation in the USA, titled Clinical Laboratory Improvement Amendments (CLIA). I participated in providing opinions from afar on this legislation, which has been continued with developments such as CLIA '67 and CLIA '88. I served on the boards of the Turkish Biochemical Society and the Turkish Ministry of Health, and participated in the work of creating the Medical Laboratory Regulation in Türkiye.

In 2023, the book "Risk, Quality and Process-Based Management Model in Medical Laboratories"[1] I wrote this. Medical laboratories have great importance and a significant role in healthcare. They should be carefully considered in terms of human health, patient safety, and healthcare costs. This has become even more important, especially in the digital age.

Based on my past experiences and acquired knowledge, I am reviewing the TLY 2024 Articles. My areas of interest are the knowledge, skills, and competencies in medical laboratory management. Adapted to all types of products, and evaluated according to the product lifecycle stages, the most important resource is the knowledge, skills, and competencies of the people at each stage.

The knowledge and skills of everyone involved in strategy and policy making, education, research, production, and implementation affect success. In particular, implementers should be supported in learning new information and acquiring competencies amidst their busy daily work. The necessary training and education platforms for the demands of the digital age should be provided. These should be implemented through national policies.

In light of these views, I wanted to evaluate TLY 2024. Articles 13.1-13.3 and 14 of the regulation state the following: ’Methods conforming to standards accepted by the Ministry’, “nationally/internationally accepted standards”, “artificial intelligence“, “clinical decision support system”, “machine learning”, “validation of health information technologies such as approval support system”. Every medical laboratory preparing for license renewal must find answers to the following questions:

1. “Within what boundaries is the concept of "method conforming to standards accepted by the Ministry" defined?
2. Are there national guidelines, and how should they be aligned with international standards?
3. Are the "Ministry rules" defined for approval support systems clear, and how will they be integrated into the actual workflows of laboratories?
4. What resources can be used for validating clinical decision support systems and artificial intelligence applications?
5. What support mechanisms should laboratory managers have in place to prepare for the demands of the digital age?

I have summarized the topics that a medical laboratory should work on in preparation for Article 13 of TLY2024. Click here for the article..

The questions are usually answered as follows:

1. “Within what boundaries is the concept of "method conforming to standards accepted by the Ministry" defined? Laboratory managers are struggling to navigate methods, test validations, and audit preparations because they are not clearly aware of which national documents are considered "Ministry-approved standards." In practice, there is an expectation that Ministry guidelines will be compiled into an official list in addition to ISO and CLSI references.
2. How should national guidelines be aligned with international standards? Medical laboratories are preparing for both the SKS-Laboratory Set and ISO 15189 requirements; however, there is no clear guidance on how these two systems should be related or what their priority order should be. This uncertainty can lead to a loss of time and resources in accreditation and audit planning.
3. Are the "Ministry rules" defined for approval support systems (ODS) clear, and how will they be integrated into the actual workflows of laboratories? While ODS algorithms are technically support tools, the responsibility for the laboratory's approval processes still rests with human experts. This places an additional burden on managers in terms of balancing digitalization goals with regulatory responsibilities.
4. What resources can be used for validating clinical decision support systems and artificial intelligence applications? Article 14 states that "intra-laboratory validation is mandatory"; however, it is unclear in what format, with what criteria, and at what frequency this validation should be performed. Many laboratories struggle to confidently deploy AI/QMS systems due to a lack of suitable data sets and technical expertise.
5. 5. What support mechanisms should laboratory managers have in place to prepare for the demands of the digital age? The regulation mentions artificial intelligence and approval support systems; however, the areas of training, technical guidance, and legal responsibility related to these technologies are not clearly defined. Laboratory managers must develop multifaceted competencies to both maintain quality systems and adapt to digital transformation.

These questions necessitate a discussion not only of legislation but also of governance and capacity-building dimensions. The future of medical laboratories depends not only on clear definitions but also on open communication and sustainable support mechanisms.

Kind regards…

Prof. Dr. Diler Aslan

Pamukkale University Faculty of Medicine, Medical Biochemistry (1994-2019)

October 5, 2025

[1] https://www.nobelyayin.com/tibbi-laboratuvarlarda-risk-kalite-ve-surec-temelli-yonetim-modeli-20338.html (Accessed: 05.10.2025)