Cara Penyelenggaraan Laboratorium Klinik yang Baik (Good Clinical Laboratory Practice) in Indonesia

Under Article 1 point 2 of Permenkes Number 43 of 2013. Cara Penyelenggaraan Laboratorium Klinik yang Baik (Good Clinical Laboratory Practice) is defined as the implementation of activities to improve. Furthermore, Establish the quality of laboratory examination results. Its regulatory purpose is to ensure that clinical laboratory services deliver high-quality, accountable examination outcomes (Article 2).

Nine Minimum Operational Criteria

A clinical laboratory is a health laboratory that examines clinical specimens to obtain individual health information supporting disease diagnosis, treatment. In addition, Recovery (Article 1 point 1). Under Article 3(1)-(2), every clinical laboratory must meet at least nine minimum criteria: organization, rooms. Furthermore, Facilities, equipment, reagents/materials, specimens, examination methods, quality assurance, biosafety/security, and recording and reporting. Technical specifications are set out in the regulation's Annex (Article 3(4)).

Article 3(3) provides a narrow exception: where resources are limited, certain criteria may go unfulfilled only so long as the quality. Furthermore, Accuracy of laboratory examination data are not compromised.

Supervision and Practical Relevance

Guidance and supervision are carried out by the Minister of Health, provincial health office heads, regency/municipal health office heads. In addition, The public within their respective mandates (Article 4). The Minister and regional health office heads may impose administrative sanctions in the form of oral warnings and written warnings (Article 5(3)). Clinics and hospitals partnering with external laboratories for medical check-ups can use these nine criteria as a vendor evaluation checklist.

Terminology in Law 17/2023 and PP 28/2024

Law Number 17 of 2023 Article 33(2). Furthermore, PP Number 28 of 2024 Article 526(2) use the term Medical Laboratory (laboratorium medis) as a category of health laboratory that examines clinical specimens for diagnosis. Clinical management, disease monitoring, prognosis. In addition, Prevention (PP 28/2024 Article 527(1)). Although Law 17/2023 repealed Law 36/2009 and Law 44/2009 (Article 454(d)-(e)), its transitional rule preserves existing implementing regulations where consistent (Article 453(c)-(d)).

Legal basis: Permenkes Number 43 of 2013 Articles 1 points 1-2, 2, 3(1)-(4), 4, and 5(3). Law Number 17 of 2023 Articles 33(2), 453(c)-(d), and 454(d)-(e). PP Number 28 of 2024 Articles 526(2) and 527(1).