{"id":17783,"date":"2026-01-12T09:23:38","date_gmt":"2026-01-12T06:23:38","guid":{"rendered":"https:\/\/www.d-tek.com.tr\/?p=17783"},"modified":"2026-02-04T11:35:43","modified_gmt":"2026-02-04T08:35:43","slug":"tibbi-laboratuvar-yonetimi-alan-bagimsizdir-turkiye-icin-zorunlu-bir-oneri","status":"publish","type":"post","link":"https:\/\/www.d-tek.com.tr\/en\/tibbi-laboratuvar-yonetimi-alan-bagimsizdir-turkiye-icin-zorunlu-bir-oneri\/","title":{"rendered":"Common Knowledge and Skills Required in Medical (Clinical) Laboratory Management: A Mandatory Recommendation for T\u00fcrkiye"},"content":{"rendered":"<p><span style=\"font-size: 16px;\"><strong>Diler Aslan<\/strong><\/span><\/p>\n<p><span style=\"font-size: 16px;\">Healthcare provider <strong>Management of medical (clinical) laboratories<\/strong>, This differs fundamentally from the management of research and development (R&amp;D) laboratories. While R&amp;D laboratories focus on knowledge production and method development; medical laboratories... <strong>direct patient safety<\/strong>, 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, <strong>A common management training program is mandatory for all medical laboratories providing healthcare services.<\/strong>.<\/span><\/p>\n<p><span style=\"font-size: 16px;\"><strong>Management is independent of the field, technical expertise is specific to the field.<\/strong><\/span><\/p>\n<p><span style=\"font-size: 16px;\">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. <strong>area-independent<\/strong> It relies on competencies. In contrast, it involves aspects such as validating the tests being studied, measurement uncertainty, method selection, or interpretation of results. <strong>Technical skills are field-specific.<\/strong> And it should be built on a foundation of shared governance.<\/span><br \/>\n<span style=\"font-size: 16px;\">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.<\/span><\/p>\n<p><span style=\"font-size: 16px;\"><strong>What does the international framework say?<\/strong><\/span><\/p>\n<p><span style=\"font-size: 16px;\">This approach is not a preference, but a clear requirement of international standards:<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 16px;\"><strong>ISO 15189; <\/strong>Medical laboratories are categorized not by their testing area, <strong>healthcare delivery systems<\/strong> It defines management requirements as follows: (organization, risk-based thinking, quality system, continuous improvement) <strong>common to all laboratories<\/strong>; Technical requirements are field-specific.<\/span><\/li>\n<li><span style=\"font-size: 16px;\"><strong>Clinical and Laboratory Standards Institute (CLSI); <\/strong>It treats laboratory management as an interdisciplinary professional field. It includes quality management systems, leadership, and patient safety guidelines., <strong>no matter which test is being administered<\/strong> It mandates the same managerial principles.<\/span><\/li>\n<li><span style=\"font-size: 16px;\"><strong>IVD Regulation (EU IVDR); <\/strong>Not based on the economic value of the tests, <strong>patient risks and system responsibility<\/strong> It deals with validation, traceability, clinical performance, and surveillance responsibilities. <strong>field-independent<\/strong>.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 16px;\">Laboratory management in the US and EU requires not only technical expertise, <strong>a defined management competency<\/strong> It is managed accordingly. The difference in area does not change the management model.<\/span><\/p>\n<p><span style=\"font-size: 16px;\"><strong>Why do we need change in T\u00fcrkiye?<\/strong><\/span><\/p>\n<p><span style=\"font-size: 16px;\">In T\u00fcrkiye, laboratory training and planning still sometimes revolve around the question of &quot;which field is more profitable?&quot;. However, in healthcare... <strong>Training and competency planning should be based on patient safety, not economic return.<\/strong> and is based on national productivity.<\/span><br \/>\n<span style=\"font-size: 16px;\">Because:<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 16px;\">For all medical laboratories providing healthcare services <strong>a joint management training regardless of field<\/strong> It should be defined.,<\/span><\/li>\n<li><span style=\"font-size: 16px;\">Those who have not completed this training should not be able to assume laboratory management positions.,<\/span><\/li>\n<li><span style=\"font-size: 16px;\">Field-specific technical competencies are part of this core training. <strong>complement<\/strong> It should be structured as such.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 16px;\"><strong>In summary<\/strong><\/span><\/p>\n<p><span style=\"font-size: 16px;\">Medical laboratory management is not a &quot;naturally acquired&quot; skill; <strong>It is a separate, defined, and standards-based field of professional competence.<\/strong>. The common message of ISO 15189, CLSI, and EU IVDR is clear:<\/span><br \/>\n<span style=\"font-size: 16px;\"><strong>The areas may differ; the management must be the same.<\/strong><\/span><br \/>\n<span style=\"font-size: 16px;\">Adopting this approach in T\u00fcrkiye is an urgent necessity for patient safety and international compliance.<\/span><\/p>\n<p><span style=\"font-size: 16px;\"><strong>Sources<\/strong><\/span><\/p>\n<ol>\n<li><span style=\"font-size: 16px;\">TS EN ISO 15189 Medical Laboratories \u2013 Requirements for Quality and Competence (ISO 15189:2022). Turkish Standards Institute (TSE); 2023.<\/span><\/li>\n<li><span style=\"font-size: 16px;\">Quality Management System: A Model for Laboratory Services Approved Guideline\u2014Fourth Edition. CLSI Document QMS01-A4. Wayne, PA: Clinical and Laboratory Standards Institute; 2011.<\/span><\/li>\n<li><span style=\"font-size: 16px;\">Fundamentals of Quality Management Systems 12 Quality System Essentials (QSE) [Internet]. [cited 2026 Jan 12]. Available from: <a href=\"https:\/\/reach.cdc.gov\/sites\/default\/files\/job-aids-resources\/f-qms%2012%20qse%20job%20aid-branded.pdf\">https:\/\/reach.cdc.gov\/sites\/default\/files\/job-aids-resources\/f-qms%2012%20qse%20job%20aid-branded.pdf<\/a><\/span><\/li>\n<li><span style=\"font-size: 16px;\">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\u201373.<\/span><\/li>\n<li><span style=\"font-size: 16px;\">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.<\/span><\/li>\n<\/ol>\n<p><span style=\"font-size: 16px;\">Prof. Dr. Diler Aslan<\/span><\/p>\n<p><span style=\"font-size: 16px;\">ORCID ID: <a href=\"https:\/\/orcid.org\/0000-0003-4907-9445\">0000-0003-4907-9445<\/a><\/span><\/p>\n<p><span style=\"font-size: 16px;\">January 12, 2026<\/span><\/p>","protected":false},"excerpt":{"rendered":"<p>Diler Aslan Sa\u011fl\u0131k hizmeti sunan t\u0131bbi (klinik) laboratuvarlar\u0131n y\u00f6netimi, ara\u015ft\u0131rma-geli\u015ftirme (Ar-Ge) laboratuvarlar\u0131n\u0131n y\u00f6netiminden temelde farkl\u0131d\u0131r. Ar-Ge laboratuvarlar\u0131 bilgi \u00fcretimine ve y\u00f6ntem geli\u015ftirmeye odaklan\u0131rken; t\u0131bbi laboratuvarlar do\u011frudan hasta g\u00fcvenli\u011fi, klinik karar deste\u011fi ve sa\u011fl\u0131k hizmetinin s\u00fcreklili\u011fiyle ili\u015fkilidir. Bu nedenle, biyokimya, mikrobiyoloji, patoloji, genetik ya da ba\u015fka bir disiplin fark etmeksizin, sa\u011fl\u0131k hizmeti veren t\u00fcm t\u0131bbi laboratuvarlar&hellip;<\/p>","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[63],"tags":[236,238,239,235,237,234],"post_series":[],"class_list":["post-17783","post","type-post","status-publish","format-standard","hentry","category-blog","tag-clsi-kalite-sistem-sartlari-in-vito-diyagnostik-tibbi-cihaz-yonetmeligi","tag-clsi-quality-system-essentials","tag-eb-ivdtt","tag-iso-15189","tag-mecial-clinical-laboratory-management","tag-tibbi-laboratuvar-klinik-yonetimi","entry","no-media"],"_links":{"self":[{"href":"https:\/\/www.d-tek.com.tr\/en\/wp-json\/wp\/v2\/posts\/17783","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.d-tek.com.tr\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.d-tek.com.tr\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.d-tek.com.tr\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.d-tek.com.tr\/en\/wp-json\/wp\/v2\/comments?post=17783"}],"version-history":[{"count":4,"href":"https:\/\/www.d-tek.com.tr\/en\/wp-json\/wp\/v2\/posts\/17783\/revisions"}],"predecessor-version":[{"id":17796,"href":"https:\/\/www.d-tek.com.tr\/en\/wp-json\/wp\/v2\/posts\/17783\/revisions\/17796"}],"wp:attachment":[{"href":"https:\/\/www.d-tek.com.tr\/en\/wp-json\/wp\/v2\/media?parent=17783"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.d-tek.com.tr\/en\/wp-json\/wp\/v2\/categories?post=17783"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.d-tek.com.tr\/en\/wp-json\/wp\/v2\/tags?post=17783"},{"taxonomy":"post_series","embeddable":true,"href":"https:\/\/www.d-tek.com.tr\/en\/wp-json\/wp\/v2\/post_series?post=17783"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}