Part 1 Introductory
(1) These Principles apply to the exercise by the Minister of a power under section 23DN of the Act on and after commencement in relation to:
(a) an application for approval of premises as an accredited pathology laboratory whether that application was made before or after commencement; and
(b) the exercise by the Minister of a power to revoke or vary an approval of premises whether the approval was given before or after commencement.
accreditation action means an independent body’s grant, refusal to grant or revocation of accreditation, however any of these actions are described, in relation to the rendering of some or all of the pathology services at premises.
designated person means a person who is designated in an application for approval under section 23DN of the Act as the person responsible for a premises’ compliance with relevant standards.
NPAAC means the National Pathology Accreditation Advisory Council established under subsection 9(1) of the National Health Act 1953.
pathologist means a medical practitioner recognised as a specialist for the purposes of the Act in relation to any of the specialties listed in Column 3, Item 113 of Schedule 4 of the Health Insurance Regulations 1975, or regulations made to replace those regulations.
(a) been trained and successfully examined or assessed as competent by the relevant College, professional society, or credentialing body; and
S(FC) laboratory has the same meaning as in the Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Eighth Edition 2025).
special adviser means a person appointed by the Minister to advise the Minister on the standards of pathology services rendered at premises.
State accreditation means accreditation under an accreditation system under the written law of a State or under a State Government administrative arrangement to provide accreditation, however described, for provision of pathology services.
(3) Subject to subsection (4), the Minister may approve an organisation as an independent body in relation to a category or categories of laboratory for the purposes of these Principles.
(a) ordinarily an organisation other than NATA should be approved only if there is a high level of confidence that the organisation is a suitable organisation to act as an independent body for the purposes of these Principles; and
(5) A reference in these Principles to the revocation of accreditation by an independent body or to revocation of State accreditation includes, without limitation:
that has the effect of revoking, cancelling, suspending or rendering inoperative the accreditation, or an aspect of the accreditation, no matter what term is used to describe that action.
(6) In these Principles a reference to an application for approval under section 23DN of the Act includes without limitation an application for a variation of an approval:
(1) These are the Principles to be applied by the Minister in exercising his or her powers under section 23DN of the Act:
(a) support the diagnosis and treatment of illness in the community by providing Medicare benefits in relation to pathology services that provide reliable results; and
(b) reduce the risk of misdiagnosis through misleading results being provided by pathology services that do not provide reliable results; and
(d) protect limited public funds available for Medicare benefits by only providing Medicare benefits in relation to pathology services that provide reliable results; and
(e) ensure that, as far as practicable, premises will be approved in principle, and will remain approved under section 23DN of the Act, for the kind of pathology services and for the category, only if it is established with a high level of confidence that the pathology services to be rendered, or rendered, at the premises meet, and can be expected to continue to meet, relevant standards for those kinds of services and for that category.
(1) When considering the making of a decision under section 23DN of the Act in relation to premises, the Minister must take into account:
(2) The Minister may take into account an advisory report, an assessment report or an accreditation action which is not the most recent.
(a) views expressed or implied by an independent body in its advisory report or assessment report, or by its accreditation action, or by a special adviser in its assessment report; and
(b) any other person’s view obtained and put forward by an applicant for approval or by the holder of an approval under section 23DN of the Act;
the Minister should generally give greater weight to the views of the independent body or the special adviser, as appropriate.
(1) The Minister must continue to apply the Principles, including taking into account a relevant advisory report, assessment report or accreditation action, even if a person affected by the report or accreditation action is seeking review by the independent body or special adviser concerned, or by a judicial or other review body, of the report or accreditation action.
(a) the Minister has made a decision under section 23DN of the Act after taking into account an advisory report, assessment report or accreditation action of an independent body, or an assessment report of a special adviser; and
(b) the report or accreditation action is later varied, or a judicial or other body has set aside or varied the report or accreditation action;
the Minister must take into account the circumstances referred to in paragraph (2)(b) when considering a new application for approval under section 23DN of the Act.
(e) be certified by an officer of the independent body or by the special adviser to contain a true report of the views of the individuals who participated in the assessment.
(a) must state whether or not it has been established with a high level of confidence that the pathology services to be rendered or rendered at the premises subject to the report meet, and can be expected to continue to meet, the relevant standards; and
(i) by reference to items in the pathology services table, or by reference to groups of items in the pathology services table, the kind of pathology services in respect of which the premises should be approved or should remain approved; and
(1) When making a decision under section 23DN of the Act in relation to premises, without limiting other sections in these Principles, the Minister may also take into account:
(a) any other report, assessment or decision about accreditation which has been prepared or made at any time by an independent body or a special adviser or in the course of State accreditation which:
(ii) relates to any persons employed or to be employed in or otherwise associated with or to be associated with the provision of pathology services at the premises; and
(b) any circumstance that gives the Minister reasonable cause to believe that an approved pathology authority or an approved pathology practitioner who is, or may be, associated with the operation of the laboratory at the premises has breached an undertaking at any time; and
(2) Paragraphs (1)(a) and (1)(b) apply whether or not the current applicant for approval or holder of approval was associated with the premises at the time of the report, assessment or decision or at the time of the events taken into account in the report, assessment or decision or at the time the circumstance arose.
(1) In the absence of exceptional circumstances, the Minister must not approve in principle premises unless the Minister is satisfied with a high level of confidence that:
(2) Subject to section 12, the Minister must only consider an application for approval of premises under section 23DN of the Act if the Minister is provided with an assessment report which is the most recent assessment report in relation to the premises.
(3) In the absence of exceptional circumstances, the Minister must not approve in principle premises if within the 6 months preceding the application the last accreditation action in relation to the premises the subject of the application was:
(a) a refusal by an independent body to grant an accreditation for pathology services rendered at the premises in relation to the kinds of services or to the category subject to the application before the Minister; or
(b) a revocation by an independent body of an accreditation held for pathology services rendered at premises in relation to the kinds of services or to the category subject to the application before the Minister.
(4) In the absence of exceptional circumstances, the Minister must not give an approval in principle unless the Minister is satisfied that the assessment report referred to in subsection (2) supports the approval of the premises as an accredited pathology laboratory for:
(5) If premises are not approved in principle on account of the operation of subsection (4), and the applicant amends the application in relation to:
covered by the application, the Minister may consider and deal with the amended application in accordance with these Principles as if it were an original application.
(1) If no independent body or special adviser has provided an assessment report in relation to premises, the Minister may consider an application for approval under section 23DN of the Act in relation to those premises and otherwise deal with the application taking into account these Principles if:
(2) This subsection applies if an application for approval in relation to premises under section 23DN of the Act is made in relation to:
not subject to an approval in principle or an approval under section 23DN of the Act held by the applicant for those premises at the time of making the application.
(3) In the absence of exceptional circumstances, the Minister must approve in principle an application which relies on this section if the application is supported by a report from an independent body which states:
(c) that the independent body is satisfied with a high level of confidence, taking into account the arrangements in relation to the operation of the premises, that:
(ii) the premises are, or will be, appropriately staffed with persons to render, and persons to direct, control and supervise, the pathology services to be rendered at the premises; and
(iii) the laboratory is, or will be at the relevant time, participating in a quality assurance program of an independent quality assurance body designed to ensure that the laboratory operates in accordance with the accreditation materials applicable to the kinds of pathology services to which approval of the premises would relate; and
(d) the kind of pathology services in respect of which the premises should be approved (identified by reference to items in the pathology services table or by reference to groups of items in the pathology services table); and
Note: The independent quality assurance body mentioned in subparagraph (3)(c)(iii) might not be an independent body within the meaning of subsection 5(2).
(1) This section applies if the State in which the premises are located has an accreditation system under which pathology laboratories may obtain accreditation for the rendering of pathology services of the kind to which the application relates.
(2) When making a decision under section 23DN of the Act, the Minister must consider, in relation to the premises, the following matters:
(b) if the premises have State accreditation, the services for which the accreditation is granted, the basis on which the accreditation was conferred and the period for which the accreditation operates; and
(a) the period of time for which the laboratory can be expected to meet relevant standards stated in the most recent assessment report; or
(2) Subject to subsection (3), the Minister must not grant an approval in reliance on an advisory report for longer than 6 months.
(3) In exceptional circumstances, the Minister may grant extensions to an approval granted in reliance on an advisory report provided that:
(1) In the absence of exceptional circumstances, the Minister must revoke an approval of premises if one or more of the following circumstances applies:
(a) the most recent assessment report states that it has not been established with a high level of confidence that the pathology services rendered at the premises covered by the approval meet, and can be expected to continue for the remainder of the period of the approval to meet, relevant standards;
(c) State accreditation relevant to pathology services covered by the approval has been revoked or has not been renewed and the holder of the approval has not provided the Minister with a satisfactory explanation for the revocation or non‑renewal of the State accreditation;
(d) the Minister has formed the view that the premises no longer meet the requirements for approval under subsection 11(1).
(2) The Minister must act in accordance with this section within 28 days of learning that any of the circumstances in subsection (1) applies.
(3) This section does not limit the considerations which the Minister may take into account when considering whether to revoke an approval under section 23DN of the Act.
(1) In the absence of exceptional circumstances, the Minister must make an appropriate variation to an approval of premises under section 23DN of the Act if one or more of the following circumstances applies:
(a) the most recent assessment report states that it has not been established with a high level of confidence that the pathology services rendered at the premises covered by the approval meet, and can be expected to continue for the remainder of the period of the approval to meet, relevant standards in relation to some of the kinds of services covered by the approval;
(b) an independent body varies an accreditation relating to the kind of pathology services that may be rendered at the premises by removing a service from that accreditation;
(c) State accreditation relevant to any of the services covered by the approval in relation to the premises has been revoked or has not been renewed and the Minister has not been provided by the holder of the approval with a satisfactory explanation of the revocation or non‑renewal of the State accreditation.
(2) The Minister must act in accordance with this section within 28 days of learning that any of the circumstances in subsection (1) applies.
(3) This section does not limit the considerations which the Minister may take into account when considering whether to vary an approval under section 23DN of the Act.
(1) The categories of accreditation of pathology laboratories for the purposes of section 23DN of the Act and the criteria applicable to each of those categories are set out in the following table:
| Item | Category | Criteria |
|---|
| 1 | Category GX (General) | Either of the following:(a) premises comprising a laboratory, or a number of co‑located laboratories, that:(i) are under the full‑time onsite direction and control of a designated person, who is a pathologist; and(ii) render services in 1 or more groups of pathology testing either:(A) under the full‑time supervision of a pathologist (whether or not the designated person) with the relevant scope of practice; or(B) if the groups of pathology testing are in 1 or more pathology disciplines with a national workforce shortage and the laboratory, or co‑located laboratories, are unable to recruit a full‑time pathologist with the relevant scope of practice—under the supervision of a pathologist (whether or not the designated person);(b) premises comprising a laboratory, a number of co‑located laboratories or a network of laboratories, that:(i) are a recognised national blood service; and(ii) are under the full‑time direction, control and supervision of a designated person, who is a pathologist with the relevant scope of practice; and(iii) render a limited range of pathology testing under the full‑time supervision of a pathologist (whether or not the designated person) with the relevant scope of practice. |
| 2 | Category GY (General) | Premises comprising a laboratory, or a number of co‑located laboratories, that:(a) are related by an appropriate arrangement to a GX laboratory; and(b) are under the direction and control of the designated person of the related GX laboratory; and(c) render services in 1 or more groups of pathology testing either:(i) under the full‑time onsite supervision of a pathologist (whether or not the designated person) with the relevant scope of practice; or(ii) if:(A) the groups of pathology testing are in 1 or more pathology disciplines with a national workforce shortage; and(B) the laboratory, or co‑located laboratories, are unable to recruit a full‑time pathologist with the relevant scope of practice;under the supervision of a pathologist (whether or not the designated person);whether or not the premises also renders services in 1 or more groups of pathology testing under the supervision of a pathologist with the relevant scope of practice who is situated in:(d) the related GX laboratory (whether or not the pathologist is the designated person); or(e) another GY laboratory that is related to that GX laboratory. |
| 3 | Category B (Branch) | Premises comprising a laboratory, or a number of co‑located laboratories, that:(a) are related by an appropriate arrangement to a GX laboratory or GY laboratory; and(b) are under the direction and control of the same designated person as the related laboratory; and(c) render services in 1 or more groups of pathology testing under the supervision of a pathologist (whether or not the designated person) from a laboratory within the pathology network. |
| 4 | Category M (Medical) | Premises comprising a laboratory that:(a) is under the full‑time onsite direction, control and supervision of a designated person, who is a medical practitioner; and(b) renders a limited range of pathology testing only for the patients of a medical practice that:(i) is operated by, or employs, the designated person; and(ii) is co‑located with the laboratory. |
| 5 | Category S (Specialised) | Any of the following:(a) premises comprising a laboratory that:(i) is under the full‑time direction, control and supervision of a designated person, who is:(A) a medical practitioner with specialised scope of practice; and(B) not a pathologist; and(ii) renders a limited range of pathology testing:(A) for a target patient population or of a specialised nature; and(B) that is restricted to the field of pathology testing directly related to the scope of practice of the designated person;(b) premises comprising a laboratory that:(i) operates as a branch of a laboratory which meets the criteria in paragraph (a); and(ii) is under the direction, control and supervision of the designated person of that laboratory;(c) premises comprising a laboratory that:(i) is under the full‑time direction, control and supervision of a designated person, who is:(A) a medical practitioner; and(B) not a pathologist; and(ii) renders a limited range of pathology testing:(A) for a target patient population or of a specialised nature; and(B) that is in 1 or more pathology disciplines with a national workforce shortage;(d) premises comprising an S(FC) laboratory that:(i) is under the full‑time direction, control and supervision of a designated person, who is:(A) a medical practitioner with a specialised scope of practice; and(B) not a pathologist; and(ii) renders a limited range of pathology testing that is:(A) restricted to tests related to fertility control testing; and(B) under the full‑time supervision of the designated person. |
(2) In the table in subsection (1), appropriate arrangement means a written arrangement that includes provision for the direction, control and supervision of the relevant laboratory.
(3) The category of accreditation allocated to premises that is specified by the Minister in an approval under section 23DN of the Act must be the category set out in the table in subsection (1) that is appropriate to the premises having regard to the criteria applicable to that category.
Note: For the purpose of determining the fee payable for an application for approval as a particular category of laboratory, the categories set out below correspond to the categories specified in section 6 of the Health Insurance (Pathology) (Fees) Act 1991:
(3) Without limiting subsection (2), the designated person is responsible for compliance with the standards of direction, control and supervision that apply to the relevant category of laboratory under the Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Eighth Edition 2025), including in relation to:
(b) oversight and management of the laboratory’s staff and processes to ensure ethical patient care and the provision of accurate and timely test results.
(5) The responsibilities of the designated person for premises under this section may be delegated, but only in accordance with the Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Eighth Edition 2025).
Note: The Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Eighth Edition 2025) is listed in Schedule 1.
(b) renders services in 1 or more groups of pathology testing that are in 1 or more pathology disciplines with a national workforce shortage.
| Item | Material | Publication year |
|---|
| 1 | Requirements for the Estimation of Measurement Uncertainty | 2007 |
| 2 | Guidelines for Approved Pathology Collection Centres (Requirements for Medical Pathology Specimen Collection) (Third Edition 2013) | 2013 |
| 3 | Requirements for Medical Testing for Human Genetic Variation (Third Edition 2022) | 2022 |
| 4 | Requirements for Information Communication and Reporting (Fifth Edition 2022) | 2022 |
| 5 | Requirements for Laboratory Testing for Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) (Fourth Edition 2023) | 2023 |
| 7 | Requirements for Medical Testing of Microbial Nucleic Acids (Second Edition 2013) | 2013 |
| 8 | Requirements for the Facilities and Operation of Mortuaries (Third Edition 2013) | 2013 |
| 9 | Requirements for the Packaging and Transport of Pathology Specimens and Associated Materials (Fifth Edition 2022) | 2022 |
| 10 | Requirements for the Performance of Anatomical Pathology Cut‑Up (Fourth Edition 2013) | 2013 |
| 11 | Requirements for cervical screening (Third Edition 2025) | 2025 |
| 12 | Requirements Procedures related to the Collection, Processing, Storage and Issue of Human Haemopoietic Progenitor Cells (Sixth Edition 2021) | 2021 |
| 13 | Requirements for Human Medical Genome Testing Utilising Massively Parallel Sequencing Technologies (First Edition 2017) | 2017 |
| 15 | Requirements for Semen Analysis (First Edition 2017) | 2017 |
| 16 | Requirements for Transfusion Laboratory Practice (Fifth Edition 2022) | 2022 |
| 17 | Requirements for Medical Pathology Services (Third Edition 2018) | 2018 |
| 18 | Requirements for Quality Control, External Quality Assurance and Method Evaluation (Sixth Edition 2017) | 2018 |
| 19 | Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Eighth Edition 2025) | 2025 |
| 20 | Requirements for the Development and Use of In‑House In Vitro Diagnostic Medical Devices (Fourth Edition 2018) | 2018 |
| 21 | Requirements for the Retention of Laboratory Records and Diagnostic Material (Ninth Edition 2022) | 2022 |
| 23 | Requirements for the Communication of High Risk Pathology Results (First Edition 2020) | 2020 |
| 23A | Requirements for Point of Care Testing (Second Edition 2021) | 2021 |
| 24 | Requirements for the Use of Digital Images as an Alternative to Direct Microscopy (First Edition 2021) | 2021 |
Note: The documents mentioned could in 2025 be viewed on the Australian Commission on Safety and Quality in Health Care’s pathology accreditation standards webpage.
(b) renders services in 1 or more groups of pathology testing that are in 1 or more pathology disciplines with a national workforce shortage.
(2) For the purposes of this instrument, the Requirements for Medical Pathology Services (Third Edition 2018) (mentioned in table item 17 of clause 1 of this Schedule) apply, in relation to the designated person, as if the definition of designated person in those requirements did not include a reference to relevant scope of practice.