Clinical laboratory quality assurance

High-quality clinical laboratory services are essential to providing quality health care. FHI 360 expands the capacity of clinical laboratories to respond effectively to public health challenges and provide accurate, timely and reliable diagnostic results. Our work helps to improve and assure the quality of clinical laboratories to prevent:

Inappropriate or delayed treatment decisions
Lapses in detection and surveillance of disease epidemics
Errors in clinical and biomedical research

FHI 360's teams of local quality assurance experts help underresourced clinical laboratories to improve their services through needs assessments, program enhancements, training and technical assistance.

We establish and support external quality assurance programs and retesting strategies to assist laboratories in verifying the reliability of their results; this work has been conducted in 25 countries across Asia and Africa. We also select suppliers for reagents and equipment and ensure that shipping and storage requirements are met and that staff are trained to ensure that equipment remains functional. We strengthen specimen referral systems so that specimens arrive quickly and are suitable for testing.

FHI 360 assists government hospital laboratories in working toward and achieving International Organization for Standardization (ISO) 15189 accreditation for quality and competence in medical laboratories. We also assist with accreditation by other local and international standards and guidelines, including the World Health Organization Strengthening Laboratory Management Towards Accreditation (SLMTA). We have delivered training that is tailored to each laboratory’s cultural, technical and financial context to more than 10,000 laboratory technicians and managers in more than 30 countries across Africa, Asia and South America.

FHI 360 has provided ISO strengthening technical assistance to more than 500 laboratories, and as of July 2020, more than half of them have been accredited, including the first public laboratories in Bangladesh, Botswana, Indonesia, Philippines and Vietnam. These laboratories now ensure accurate results when testing for diseases, producing timely results, respecting ethics and protecting the safety of patients and clinical staff alike. FHI 360 has been recognized for our skills and experience to improve clinical laboratory quality and is a member of the Asia Pacific Laboratory Accreditation Cooperation and the Africa Region Laboratory Accreditation Cooperation.

To improve diagnostic accuracy and safety, FHI 360 has developed various training courses to complement our work, including (1) malaria microscopy; (2) tuberculosis diagnostics; (3) HIV recency and viral load testing; (4) biosafety and biosecurity including infection control; and (5) ISO 15189 and SLMTA.

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Clinical laboratory quality assurance