What does 18(3) require?

Without limiting the general compliance duty, the designated person is responsible for compliance with the standards of direction, control and supervision that apply to the laboratory's category under the Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Eighth Edition 2025), the NPAAC document listed in Schedule 1. That responsibility expressly covers the clinical governance of the laboratory and the oversight and management of its staff and processes so that patient care is ethical and test results are accurate and timely. The Supervision Requirements carry the category-specific expectations (onsite presence, delegation, virtual supervision of GY, B and SB laboratories, annual visits) that the National Pathology Standards restate as actions.

Australia Health Insurance (Accredited Pathology...

Other controls in 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

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
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
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
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)
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
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
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
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

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The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.

MCP endpoint All Australia Health Insurance (Accredited Pathology Laboratories, Approval) Principles 2017 controls