Pemantapan Mutu Laboratorium Klinik (Clinical Laboratory Quality Assurance) in Indonesia
Under Indonesia's Permenkes Number 43 of 2013 (Articles 1 point 2 and 3(1)) and Permenkes Number 29 of 2013 Article 10(2), Pemantapan Mutu Laboratorium Klinik refers to quality assurance activities performed by a clinical laboratory to maintain accurate.
In Indonesian health regulations, Pemantapan Mutu Laboratorium Klinik refers to the quality assurance activities a clinical laboratory carries out so that its examination results remain accurate and accountable. While the main body of Permenkes Number 43 of 2013 does not contain a standalone definition entry for the noun phrase. Article 1 point 2 defines Good Clinical Laboratory Practice as executing activities to improve. Furthermore, Establish the quality (memantapkan mutu) of laboratory examination results.
Where Quality Assurance Sits in Permenkes 43/2013
Article 3(1)-(2) requires every clinical laboratory to meet nine minimum criteria: organization, rooms. Furthermore, Facilities, equipment, materials, specimens, examination methods, quality (mutu), safety, and recording and reporting. Even when resource limitations allow flexibility on certain criteria, the laboratory must never compromise the quality and accuracy of examination data (Article 3(3)). Detailed quality criteria are set out in the Annex of Permenkes 43/2013 (Article 3(4)).
Supervision and Practical Due Diligence
The Minister of Health, provincial and municipal health office heads. Furthermore, The public oversee clinical laboratories (Article 4), with administrative sanctions of oral and written warnings available under Article 5(3). Clinic and hospital managers evaluating a laboratory partner for occupational health check-ups should ask what internal. Furthermore, External quality assurance activities the laboratory performs and whether those records are maintained.
Related Terms in Permenkes 29/2013 and PP 28/2024
- Migrant Worker MCU Designation: Permenkes Number 29 of 2013 Article 10(2) explicitly requires hospitals. Furthermore, Main clinics seeking designation as a migrant worker examining facility (Sarana Kesehatan. Article 1 point 4) to conduct laboratory quality assurance (pemantapan mutu laboratorium).
- Laboratory Quality Assurance Network: PP Number 28 of 2024 uses the phrase penjaminan mutu laboratorium as a function of public health laboratories (Article 529(2)(h)). Furthermore, As part of the laboratory network with medical laboratories (Article 532(1) and (2)(d)).
- Regulatory Status: Under Law Number 17 of 2023 Articles 453(c). Furthermore, 454(d), Permenkes 43/2013 remains valid where consistent pending new Ministerial guidelines under PP 28/2024 Article 537.
Legal basis: Permenkes Number 43 of 2013 Articles 1 point 2, 3(1)-(4), 4, and 5(3). Permenkes Number 29 of 2013 Articles 1 point 4 and 10(2). PP Number 28 of 2024 Articles 529(2)(h), 532(1), 532(2)(d), and 537. Law Number 17 of 2023 Articles 453(c) and 454(d).
Related questions
Where does the exact phrase 'pemantapan mutu laboratorium' appear as a facility requirement?+
What phrase does PP 28/2024 use for laboratory quality assurance networks?+
How do clinics ensure laboratory values are accurately reflected in MCU conclusions?+
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