Australia Health Insurance (Accredited Pathology Laboratories, Approval) Principles 2017 Sch1-general: Comply with the cross-cutting NPAAC accreditation materials in Schedule 1 that apply to every accredited laboratory: medical pathology services, supervision, information communication and reporting, quality control and external quality assurance, measurement uncertainty, specimen collection, high-risk results, record retention, packaging and transport, point of care testing, in-house IVDs and digital images

What does Sch1-general require?

The accreditation materials in Schedule 1 are the relevant standards against which NATA assesses the premises and against which the Minister's high-confidence test is applied, each taken as published in the year the table names. The cross-cutting documents a general laboratory must meet are the Requirements for Medical Pathology Services (Third Edition 2018), the overarching standard; the Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Eighth Edition 2025); the Requirements for information communication and reporting (Sixth Edition 2026), substituted by the No. 3 2026 amendment from 13 July 2026 and widening electronic messaging conformance beyond HL7 version 2.4 to Australian-approved standards including FHIR; the Requirements for Quality Control, External Quality Assurance and Method Evaluation (Sixth Edition 2017); the Requirements for the Estimation of Measurement Uncertainty (2007); the Guidelines for Approved Pathology Collection Centres (Requirements for Medical Pathology Specimen Collection) (Third Edition 2013); the Requirements for the Communication of High Risk Pathology Results (First Edition 2020); the Requirements for the Retention of Laboratory Records and Diagnostic Material (Ninth Edition 2022); the Requirements for the Packaging and Transport of Pathology Specimens and Associated Materials (Fifth Edition 2022); the Requirements for Point of Care Testing (Second Edition 2021); the Requirements for the Development and Use of In-House In Vitro Diagnostic Medical Devices (Fifth Edition 2025, replaced by the Sixth Edition 2026 from 1 July 2027 under Part 2 of the No. 3 2026 amendment, which adds standards for in-house IVD software including AI); and the Requirements for the Use of Digital Images as an Alternative to Direct Microscopy (First Edition 2021). The National Pathology Standards (First Edition 2027) are not yet listed in Schedule 1 at Compilation No. 19; they are designed to replace seven of these documents once designated.