📋 Schema Card
- Standard: ISO 15189 (Accredited since 2006)
- Target Audience: Diagnostic and clinical laboratories.
- Core Value: Validates competence to deliver timely, accurate, and reliable results with patient-centric outcomes.
Scheme Overview
Developed with the participation of the medical, scientific, and clinical communities, this scheme provides independent and impartial evaluation of diagnostic services. The assessment examines personnel qualifications, equipment, reagents, quality assurance, and pre/post-analytical factors.
The 5 Critical Criteria
Accreditation places five additional critical responsibilities on medical laboratories:
- Advisory Services: Providing guidance on the type of samples and testing required.
- Clinical Liaison: Interacting responsibly with clinicians who refer patient samples.
- Expert Opinion: Providing insights on test results in relation to diagnosis and patient care.
- Sample Management: Collecting samples or providing detailed information on collection procedures, containers, and volumes.
- Ethical Practice: Ensuring the primary duty is always to the patient, rather than just the "customer."
Covered Disciplines
✓ Clinical Biochemistry / Chemical Pathology
✓ Clinical Pathology
✓ Haematology and Immunohaematology
✓ Microbiology and Serology
✓ Histopathology / Cytopathology
✓ Immunology
✓ Molecular Biology
✓ Pharmacology
✓ Andrology
✓ Nuclear Medicine
✓ Embryology
Ongoing Compliance
Laboratories are regularly reassessed and must participate in regular Proficiency Testing programs (External Quality Assurance Programs - EQAS) to maintain their accredited status.