Common Knowledge and Skills Required in Medical (Clinical) Laboratory Management: A Mandatory Recommendation for Türkiye

Diler Aslan

Healthcare provider Management of medical (clinical) laboratories, This differs fundamentally from the management of research and development (R&D) laboratories. While R&D laboratories focus on knowledge production and method development; medical laboratories... direct patient safety, It is related to clinical decision support and continuity of healthcare. Therefore, regardless of whether it is biochemistry, microbiology, pathology, genetics or any other discipline, A common management training program is mandatory for all medical laboratories providing healthcare services..

Management is independent of the field, technical expertise is specific to the field.

The management of a medical laboratory includes aspects such as quality and risk management, process design, error and nonconformity management, data integrity, regulatory compliance, and patient safety. area-independent It relies on competencies. In contrast, it involves aspects such as validating the tests being studied, measurement uncertainty, method selection, or interpretation of results. Technical skills are field-specific. And it should be built on a foundation of shared governance.
In short: From the perspective of human health, patient safety, and national health spending, how you manage your laboratory is just as important as which tests you run.

What does the international framework say?

This approach is not a preference, but a clear requirement of international standards:

• ISO 15189; Medical laboratories are categorized not by their testing area, healthcare delivery systems It defines management requirements as follows: (organization, risk-based thinking, quality system, continuous improvement) common to all laboratories; Technical requirements are field-specific.
• Clinical and Laboratory Standards Institute (CLSI); It treats laboratory management as an interdisciplinary professional field. It includes quality management systems, leadership, and patient safety guidelines., no matter which test is being administered It mandates the same managerial principles.
• IVD Regulation (EU IVDR); Not based on the economic value of the tests, patient risks and system responsibility It deals with validation, traceability, clinical performance, and surveillance responsibilities. field-independent.

Laboratory management in the US and EU requires not only technical expertise, a defined management competency It is managed accordingly. The difference in area does not change the management model.

Why do we need change in Türkiye?

In Türkiye, laboratory training and planning still sometimes revolve around the question of "which field is more profitable?". However, in healthcare... Training and competency planning should be based on patient safety, not economic return. and is based on national productivity.
Because:

• For all medical laboratories providing healthcare services a joint management training regardless of field It should be defined.,
• Those who have not completed this training should not be able to assume laboratory management positions.,
• Field-specific technical competencies are part of this core training. complement It should be structured as such.

In summary

Medical laboratory management is not a "naturally acquired" skill; It is a separate, defined, and standards-based field of professional competence.. The common message of ISO 15189, CLSI, and EU IVDR is clear:
The areas may differ; the management must be the same.
Adopting this approach in Türkiye is an urgent necessity for patient safety and international compliance.

Sources

1. TS EN ISO 15189 Medical Laboratories – Requirements for Quality and Competence (ISO 15189:2022). Turkish Standards Institute (TSE); 2023.
2. Quality Management System: A Model for Laboratory Services Approved Guideline—Fourth Edition. CLSI Document QMS01-A4. Wayne, PA: Clinical and Laboratory Standards Institute; 2011.
3. Fundamentals of Quality Management Systems 12 Quality System Essentials (QSE) [Internet]. [cited 2026 Jan 12]. Available from: https://reach.cdc.gov/sites/default/files/job-aids-resources/f-qms%2012%20qse%20job%20aid-branded.pdf
4. Aslan D. Which skills are needed and how they should be gained by laboratory medicine professionals for successful ISO 15189 accreditation. eJIFCC2018Vol29No4pp264-273. 29:264–73.
5. Aslan D. Competencies for Medical (Clinical) Laboratory Management. Aslan D. Risk, Quality and Process-Based Management Model in Medical Laboratories. 1st ed. Nobel Academic Publishing Ankara; 2023: 637-728.

Prof. Dr. Diler Aslan

ORCID ID: 0000-0003-4907-9445

January 12, 2026