Australia National Pathology Standards (First Edition 2027) 10.02: Analytical and clinical performance: ensure analytical performance meets the assay's clinical application, support morphological and interpretive diagnostic performance through peer review, internal and external quality assurance, confine unverified tests to exceptional circumstances or rare or new diseases, use peer consultation for new or uncommon morphological assessments, confirm comparability across methods and devices, support morphological comparability through documented peer review and case comparison, and keep authorised test procedures available including which specimen types or diagnoses need mandatory peer review, the peer review process and the handling of discordant diagnoses

What does 10.02 require?

Analytical performance has to be good enough for the clinical question each assay answers. Morphological and interpretive work is underpinned by peer review and by internal and external quality assurance matched to clinical use; unverified tests are run only in exceptional cases or for rare or new disease; novel or uncommon morphological calls are backed by peer consultation; results from different methods or devices are shown to be comparable; and in morphology, agreement between practitioners is demonstrated by recorded peer review and side-by-side case comparison, using slide exchange schemes and second opinions, formal or informal, as the situation warrants. The authorised, available test procedures also set out which specimen types or diagnoses must be peer reviewed, how peer review is done, and how a disagreement between diagnosticians is recorded, escalated and settled.