ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
Clause 7: Process requirements – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence 7.3.5: Biological reference intervals and clinical decision limits
What does 7.3.5 require?
Where interpretation depends on them, the laboratory shall set clinical decision limits and biological reference intervals, recorded with their basis and communicated to users; they shall reflect the population the laboratory serves and take patient risk into account, and values from the manufacturer may be used once their population basis has been verified. They shall be reviewed at intervals, with changes communicated. If an examination or pre-examination method changes, the effect on these intervals and limits shall be reviewed and communicated. For examinations that detect presence or absence, the reference interval is the characteristic being identified.
This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
10.08 Test results: ensure the workforce determining results are competent, work in optimal conditions with appropriate equipment for interpretation, have evidence-based reference intervals and clinical decision limits; ensure results are correct, evaluated against internal controls, timely, unambiguous, clinically relevant and traceable to the request; flag on the report that diagnostic validity is not established for clinically non-validated tests; and document critical result thresholds and escalation processes