Urgent Call for Action: Bridging Gaps in Asia-Pacific Laboratories' Transition to ISO 15189:2022

Area of Science:

• Medical Laboratory Science
• Quality Management Systems
• Diagnostic Accuracy

Background:

• ISO 15189:2022 updates medical laboratory standards, focusing on risk management, ethics, and technical competence.
• A transition deadline from ISO 15189:2012 to ISO 15189:2022 is set for December 2025.
• The Asia-Pacific Federation of Clinical Biochemistry and Laboratory Medicine (APFCB) webinar provided a platform for assessing readiness.

Purpose of the Study:

• To evaluate the readiness of medical laboratories for the ISO 15189:2022 transition.
• To identify awareness levels, perceived importance, and expected benefits of the revised standard.
• To determine the major barriers and preparation strategies for the ISO 15189:2022 adoption.

Main Methods:

• A cross-sectional survey was conducted during an APFCB webinar on February 21, 2025.
• 303 responses were collected to assess laboratory preparedness.
• Data analysis focused on awareness, barriers, and preparation efforts related to ISO 15189:2022.

Main Results:

• High awareness (85%) of ISO 15189:2022 and its emphasis on risk management (92%) was reported.
• Most participants (78%) deemed the transition important, expecting quality and patient care improvements (82%).
• Key barriers included insufficient training (72%) and financial constraints (65%), while gap analyses (68%) and training programs (75%) were common preparation efforts.

Conclusions:

• Laboratories are optimistic about ISO 15189:2022, but resource limitations and skills gaps pose adoption challenges.
• Structured training, financial aid, and expert guidance are crucial, especially for resource-limited settings.
• Collaboration is vital for a smooth transition, ensuring accurate, reliable, and patient-centered diagnostics.