Laboratorium Klinik (Clinical Laboratory) under Indonesian Health Law

Under Article 1 point 1 of Permenkes Number 43 of 2013. A Laboratorium Klinik (Clinical Laboratory) is a health laboratory that performs clinical specimen examination services to obtain information about an individual's health. Primarily to support disease diagnosis, treatment, and health recovery. Under the Elucidation of Article 529(1) of PP Number 28 of 2024. A clinical specimen is material originating or taken from the human body, including for diagnostic purposes.

Position in Law 17/2023 and PP 28/2024

Law Number 17 of 2023 Article 33(2) divides health laboratories into medical laboratories (laboratorium medis), public health laboratories (laboratorium kesehatan masyarakat). In addition, Other laboratories designated by the Minister. PP 28/2024 Article 527(1) describes a medical laboratory as examining clinical specimens for diagnosis, clinical management, disease monitoring, prognosis, and disease prevention. While that function closely mirrors the definition of a clinical laboratory in Permenkes 43/2013. The newer statutes do not explicitly state that the two terms are identical.

Although Law 17/2023 repealed Law 36/2009. Furthermore, Law 44/2009 (Article 454(d)-(e)). Its transitional provision keeps implementing regulations such as Permenkes 43/2013 valid so long as they do not conflict with Law 17/2023 (Article 453(c)-(d)).

Licensing and Operational Structure

Health laboratories are classified as supporting healthcare facilities (fasilitas pelayanan kesehatan penunjang, PP 28/2024 Article 764(3)(c)). In addition, Every healthcare facility must hold business licensing (Law 17/2023 Article 165(5)). Supporting healthcare facilities may operate independently or be integrated within a primary or advanced healthcare facility (PP 28/2024 Article 764(2)).

Related Regulatory Terms

• Public Health Laboratory (Laboratorium Kesehatan Masyarakat): Examines clinical specimens and tests environmental/population samples for disease prevention and control (PP 28/2024 Article 529(1)).
• Good Clinical Laboratory Practice (Cara Penyelenggaraan Laboratorium Klinik yang Baik): Activities to improve. Furthermore, Assure the quality of laboratory examination results (Permenkes 43/2013 Article 1 point 2).

Legal basis: Permenkes Number 43 of 2013 Article 1 points 1-2. Law Number 17 of 2023 Articles 33(2), 165(5), 453, and 454. PP Number 28 of 2024 Articles 527(1), 529(1) and Elucidation, and 764(2), (3)(c).