Australia Health Insurance (Accredited Pathology Laboratories, Approval) Principles 2017
Australia's Approval Principles for accredited pathology laboratories under the Health Insurance Act 1973: the conditions for Medicare-eligible laboratory approval, the GX, GY, B, M and S categories, the designated person's direction, control and supervision duties, and the NPAAC accreditation materials incorporated as relevant standards.
Australia Health Insurance (Accredited Pathology Laboratories, Approval) Principles 2017 is a compliance framework from Australia (Commonwealth) with 3 domains and 14 controls that map to 2 other frameworks. The largest domains are Part 4: categories of premises and the standards of direction, control and supervision (sections 17 and 18) – Australia Health Insurance (Accredited Pathology Laboratories, Approval) Principles 2017 (9 controls), Part 3: approval of premises, interim approval, period, revocation and variation (sections 11 to 16) – Australia Health Insurance (Accredited Pathology Laboratories, Approval) Principles 2017 (3 controls), Schedule 1: accreditation materials, the relevant standards incorporated by reference – Australia Health Insurance (Accredited Pathology Laboratories, Approval) Principles 2017 (2 controls). Every control below carries what it requires and what an assessor expects to see.
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Framework Domains (3)
Part 3: approval of premises, interim approval, period, revocation and variation (sections 11 to 16) – Australia Health Insurance (Accredited Pathology Laboratories, Approval) Principles 2017
| Code | Title |
|---|---|
| australia-health-insurance-accredited-pathology-laboratories-approval-principles-2017::11 | Qualify for approval: show with a high level of confidence, through the most recent NATA assessment report, that the pathology services will meet the relevant standards for the kinds of services and the category sought, and comply with the Act and these Principles |
| australia-health-insurance-accredited-pathology-laboratories-approval-principles-2017::12 | Interim approval on an advisory report for a new kind of service or category: an independent body site visit, an appropriately equipped laboratory, staff to render and to direct, control and supervise the services, and enrolment in an independent quality assurance program, for no more than six months |
| australia-health-insurance-accredited-pathology-laboratories-approval-principles-2017::15-16 | Keep the approval alive: maintain a favourable assessment, current NATA accreditation and any State accreditation for every kind of service covered, and give the Minister a satisfactory explanation for any State accreditation lapse, because revocation or variation must follow within 28 days of an adverse trigger |
Part 4: categories of premises and the standards of direction, control and supervision (sections 17 and 18) – Australia Health Insurance (Accredited Pathology Laboratories, Approval) Principles 2017
| Code | Title |
|---|---|
| australia-health-insurance-accredited-pathology-laboratories-approval-principles-2017::17(2)-(3) | Hold a written arrangement providing for direction, control and supervision wherever a laboratory relies on a related laboratory, and operate only in the category the Minister specified as appropriate to the premises on the section 17 criteria |
| australia-health-insurance-accredited-pathology-laboratories-approval-principles-2017::17-B | Category B (Branch): a laboratory related by a written arrangement to a GX or GY laboratory, under the same designated person as the related laboratory, with testing supervised by a pathologist from within the pathology network |
| australia-health-insurance-accredited-pathology-laboratories-approval-principles-2017::17-GX | Category GX (General): a laboratory or co-located laboratories under the full-time onsite direction and control of a pathologist designated person, with each group of pathology testing under the full-time supervision of a pathologist with the relevant scope of practice, or a recognised national blood service under a pathologist's full-time direction, control and supervision |
| australia-health-insurance-accredited-pathology-laboratories-approval-principles-2017::17-GY | Category GY (General): a laboratory related by a written arrangement to a GX laboratory, under the direction and control of the GX designated person, with each group of testing under full-time onsite pathologist supervision with the relevant scope of practice (or network-based supervision for some groups) |
| australia-health-insurance-accredited-pathology-laboratories-approval-principles-2017::17-M | Category M (Medical): a laboratory under the full-time onsite direction, control and supervision of a medical practitioner designated person, rendering a limited range of testing only for patients of the co-located medical practice that operates or employs that practitioner |
| australia-health-insurance-accredited-pathology-laboratories-approval-principles-2017::17-S | Category S (Specialised): a laboratory under the full-time direction, control and supervision of a non-pathologist specialist medical practitioner, rendering a limited range of testing for a target population or of a specialised nature within that practitioner's scope, including its branch, the workforce-shortage variant and the S(FC) fertility control laboratory |
| australia-health-insurance-accredited-pathology-laboratories-approval-principles-2017::18(1)-(2) | Place the premises under the direction, control and supervision of a designated person who holds appropriate qualifications, is competent and has the relevant scope of practice, and who carries responsibility for the premises' compliance with the relevant standards |
| australia-health-insurance-accredited-pathology-laboratories-approval-principles-2017::18(3) | Meet the standards of direction, control and supervision for the laboratory's category set by the Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Eighth Edition 2025), including clinical governance and oversight of staff and processes for ethical patient care and accurate, timely results |
| australia-health-insurance-accredited-pathology-laboratories-approval-principles-2017::18(4)-(6) | Supervise pathology testing only within the designated person's scope of practice and delegate section 18 responsibilities only as the Supervision Requirements (Eighth Edition 2025) allow, with the scope-of-practice limit relaxed only for a category S laboratory testing in a workforce-shortage discipline |
Schedule 1: accreditation materials, the relevant standards incorporated by reference – Australia Health Insurance (Accredited Pathology Laboratories, Approval) Principles 2017
| Code | Title |
|---|---|
| australia-health-insurance-accredited-pathology-laboratories-approval-principles-2017::Sch1-discipline | Comply with the discipline-specific NPAAC accreditation materials in Schedule 1 for every discipline the laboratory is approved to render: human genetic variation, HIV and hepatitis C testing, microbial nucleic acids, mortuaries, anatomical pathology cut-up, cervical screening, haemopoietic progenitor cells, massively parallel sequencing, semen analysis and transfusion practice |
| 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 |
Maps to 2 other frameworks
Coverage is not the same as your position
This page shows what Australia Health Insurance (Accredited Pathology Laboratories, Approval) Principles 2017 overlaps with in general. Where your organisation actually stands, against the standard you are going for and the certifications you already hold, is a different question. Same graph and the same recorded refutations, scoped to you rather than to a pair.
The Compliance Position Diagnostic, $5,000 fixed, ten business daysWhat is Australia Health Insurance (Accredited Pathology Laboratories, Approval) Principles 2017 and who does it apply to?
Australia Health Insurance (Accredited Pathology Laboratories, Approval) Principles 2017 is a compliance framework from Australia (Commonwealth) with 3 domains and 14 controls. Australia's Approval Principles for accredited pathology laboratories under the Health Insurance Act 1973: the conditions for Medicare-eligible laboratory approval, the GX, GY, B, M and S categories, the designated person's direction, control and supervision duties, and the NPAAC accreditation materials incorporated as relevant standards. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
What does Australia Health Insurance (Accredited Pathology Laboratories, Approval) Principles 2017 actually require?
Australia Health Insurance (Accredited Pathology Laboratories, Approval) Principles 2017 has 14 controls organised across 3 domains. The largest domains are Part 4: categories of premises and the standards of direction, control and supervision (sections 17 and 18) – Australia Health Insurance (Accredited Pathology Laboratories, Approval) Principles 2017 (9 controls), Part 3: approval of premises, interim approval, period, revocation and variation (sections 11 to 16) – Australia Health Insurance (Accredited Pathology Laboratories, Approval) Principles 2017 (3 controls), Schedule 1: accreditation materials, the relevant standards incorporated by reference – Australia Health Insurance (Accredited Pathology Laboratories, Approval) Principles 2017 (2 controls). Each control defines specific requirements that organisations must implement to achieve compliance.
If I already comply with another framework, how much of Australia Health Insurance (Accredited Pathology Laboratories, Approval) Principles 2017 do I already cover?
Australia Health Insurance (Accredited Pathology Laboratories, Approval) Principles 2017 maps to 2 other compliance frameworks. The top mapping partners are Australia National Pathology Standards (First Edition 2027) (64% coverage), ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence (14% coverage). Use our comparison tool to explore control-level mappings between frameworks.
How do I implement Australia Health Insurance (Accredited Pathology Laboratories, Approval) Principles 2017?
Start your Australia Health Insurance (Accredited Pathology Laboratories, Approval) Principles 2017 compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about Australia Health Insurance (Accredited Pathology Laboratories, Approval) Principles 2017 requirements, and cross-framework mapping helps you leverage existing controls from other frameworks you may already comply with. Create a free account to access all 14 controls and track your progress.
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