Kepastian Hukum Akreditasi Laboratorium Medis Terhadap Praktik Ahli Teknologi Laboratorium Medis

  • Dede Hermawan Universitas Dr. Soetomo Surabaya
  • Dudik Djaja Sidarta Universitas Dr. Soetomo Surabaya
  • Sri Sukmana Damayanti Universitas Dr. Soetomo Surabaya
  • M. Taufik Universitas Dr. Soetomo Surabaya

Keywords

Legal Certainty, Medical Laboratory Accreditation, Medical Laboratory Technology Professionals, Healthcare Professional Practice

Abstract

Medical laboratory services play an important role in the healthcare system by providing diagnostic information that serves as a basis for clinical decision-making. Therefore, quality assurance mechanisms through the accreditation of medical laboratories are necessary to ensure compliance with service standards, patient safety requirements, and good laboratory governance. However, in practice, issues remain concerning the legal relationship between medical laboratory accreditation as an institutional standard and the professional practice authority of Medical Laboratory Technology Professionals (Ahli Teknologi Laboratorium Medik/ATLM) as healthcare professionals. This study aims to analyze the legal certainty of regulations governing medical laboratory accreditation in relation to ATLM practice and to formulate an appropriate regulatory framework for ensuring such legal certainty. This study employs a normative legal research method using a statutory approach and a conceptual approach. The legal materials consist of primary legal materials in the form of laws and regulations concerning medical laboratory accreditation and ATLM practice, as well as secondary legal materials, including relevant literature, scientific journals, and legal doctrines. The legal materials are analyzed qualitatively using a descriptive-analytical method to examine the relationship between medical laboratory accreditation regulations and the professional authority of ATLMs. The results show that the regulation of medical laboratory accreditation has a legal basis through healthcare regulations, particularly Law Number 17 of 2023 on Health and Minister of Health Regulation Number 34 of 2022 on the Accreditation of Healthcare Facilities. However, these regulations do not explicitly establish the relationship between the accreditation status of medical laboratories and the authority to practice as an ATLM. Accreditation is primarily oriented toward fulfilling institutional quality standards, whereas ATLM practice authority is determined by the competence, registration, and practice license of healthcare professionals. Therefore, regulatory harmonization is needed to establish a clear relationship between medical laboratory accreditation standards and professional ATLM practice, thereby ensuring legal certainty, legal protection, and the provision of quality laboratory services

References

Andika Akiviameita et al. (2024). Buku Digital Standar Profesi ATLM.

Don-Wauchope, A. C., Rodriguez-Capote, K., Assaad, R. S., Bhargava, S., & Zemlin, A. E. (2024). A Guide to Conducting Systematic Reviews of Clinical Laboratory Tests. Clinical Chemistry and Laboratory Medicine, 62(2), 218–233. https://doi.org/10.1515/cclm-2023-0333

Firdaus, M. B. (2025). Dialektika Keadilan, Kepastian, Kemanfaatan Hukum dalam Perspektif Gustav Radbruch pada Hukum Indonesia. Jurnal Kajian Hukum dan Kebijakan Publik, 3(1), 357–367.

Hicks, A. J., Carwardine, Z. L., Hallworth, M. J., & Kilpatrick, E. S. (2021). Using Clinical Guidelines to Assess the Potential Value of Laboratory Medicine in Clinical Decision-Making. Journal of Southern African Studies, 29(3), 717–737.

Kementerian Kesehatan Republik Indonesia. (2022). Peraturan Menteri Kesehatan Republik Indonesia Nomor 24 Tahun 2022. Jakarta: Kementerian Kesehatan Republik Indonesia.

KEPDIRJEN. (2023). Keputusan Direktur Jenderal Pelayanan Kesehatan Nomor HK.02.02/D/632/2023 tentang Instrumen Survei Akreditasi Laboratorium Kesehatan. Jakarta: Kementerian Kesehatan Republik Indonesia.

Kurniawan, R. V., & Nugroho, H. P. (2025). Dentist’s Responsibility for Improper Implementation of Informed Consent. Rechtsvinding, 3(17), 1–8.

Ode Marsudi, L., & Tamara Mawardani, M. (2024). Hubungan Tingkat Kepatuhan ATLM terhadap Mutu Pelayanan Laboratorium X. Jurnal Teknologi Laboratorium Medik Borneo, 4(2).

Plebani, M. (2017). Quality in Laboratory Medicine: 50 Years On. Clinical Biochemistry, 50(3), 101–104. https://doi.org/10.1016/j.clinbiochem.2016.10.007

Plebani, M., & Sciacovelli, L. (2017). ISO 15189 Accreditation: Navigation Between Quality Management and Patient Safety. Journal of Medical Biochemistry, 36(3), 225–230. https://doi.org/10.1515/jomb-2017-0038

Prasetyani, E. (2023). Aspek Hukum pada Kewenangan ATLM dalam Pelayanan Kesehatan di Rumah Sakit. Jurnal Risalah Kenotariatan, 4(2), 426–434.

Qolbi, R. S. (2024). Pengaruh Hukum Normatif dalam Peningkatan Mutu Pelayanan dan Perlindungan Hukum Tenaga ATLM. Jurnal Hukum Legalita, 6(1), 40–49. https://doi.org/10.47637/legalita.v6i1.1308

World Health Organization (WHO). (2022). Health Care Accreditation and Quality of Care.

Undang-Undang Nomor 17 Tahun 2023 tentang Kesehatan.

Peraturan Menteri Kesehatan Nomor 34 Tahun 2022 tentang Akreditasi Pusat Kesehatan Masyarakat, Klinik, Laboratorium Kesehatan, Unit Transfusi Darah, Tempat Praktik Mandiri Dokter, dan Tempat Praktik Mandiri Dokter Gigi.

Peraturan Menteri Kesehatan Republik Indonesia Nomor 42 Tahun 2015 tentang Izin dan Penyelenggaraan Praktik Ahli Teknologi Laboratorium Medik.

2026-10-03