Federal Register of Legislation - Australian Government

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Principles as made
This instrument amends the Health Insurance (Accredited Pathology Laboratories-Approval) Principles 2017 to reflect four new and/ or revised pathology accreditation standards and other amendments to support the implementation of the Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Sixth Edition 2021).
Administered by: Health
Registered 30 Jul 2021
Tabling HistoryDate
Tabled HR03-Aug-2021
Tabled Senate03-Aug-2021
To be repealed 02 Aug 2022
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003
Table of contents.

Commonwealth Coat of Arms of Australia

 

Health Insurance (Accredited Pathology Laboratories—Approval) Amendment (Relevant Standards) Principles 2021

I, Dr Megan Keaney, as delegate of the Minister for Health and Aged Care, make the following principles.

Dated 30 July 2021

Dr Megan Keaney

Acting First Assistant Secretary
Medical Benefits Division
Health Resourcing Group
Department of Health

 

  

  


Contents

1............ Name............................................................................................................................. 1

2............ Commencement............................................................................................................. 1

3............ Authority....................................................................................................................... 1

4............ Schedules...................................................................................................................... 1

Schedule 1—Amendments                                                                                                                          2

Part 1—Amendments commencing 1 August 2021                                                                 2

Health Insurance (Accredited Pathology Laboratories—Approval) Principles 2017             2

Part 2—Amendments commencing 1 January 2022                                                                6

Health Insurance (Accredited Pathology Laboratories—Approval) Principles 2017             6

Part 3—Amendments commencing 1 August 2022                                                                 7

Health Insurance (Accredited Pathology Laboratories—Approval) Principles 2017             7

 


1  Name

                   This instrument is the Health Insurance (Accredited Pathology Laboratories—Approval) Amendment (Relevant Standards) Principles 2021.

2  Commencement

             (1)  Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.  Sections 1 to 4 and anything in this instrument not elsewhere covered by this table

The day after this instrument is registered.

31 July 2021

2.  Schedule 1, Part 1

1 August 2021.

1 August 2021

3.  Schedule 1, Part 2

1 January 2022.

1 January 2022

4.  Schedule 1, Part 3

1 August 2022.

1 August 2022

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

             (2)  Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

                   This instrument is made under subsection 23DNA(1) of the Health Insurance Act 1973.

4  Schedules

                   Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1Amendments

Part 1Amendments commencing 1 August 2021

Health Insurance (Accredited Pathology Laboratories—Approval) Principles 2017

1  Subsection 5(2)

Insert:

pathology discipline with a national workforce shortage means any of the following pathology disciplines:

                     (a)  genomics (including cytogenetics and biochemical genetics);

                     (b)  immunology;

                     (c)  chemical pathology.

S(FC) laboratory has the same meaning as in the Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Sixth Edition 2021).

2  Subsection 17(1) (cell at table item 1, column headed “Criteria”)

Repeal the cell, substitute:

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.

 

3  Subsection 17(1) (table item 2, column headed “Criteria”, paragraphs (a) and (b))

Omit “is”, substitute “are”.

4  Subsection 17(1) (table item 2, column headed “Criteria”, paragraph (c))

Repeal the paragraph, substitute:

(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);

5  Subsection 17(1) (table item 3, column headed “Criteria”, paragraphs (a) and (b))

Omit “is”, substitute “are”.

6   Subsection 17(1) (table item 3, column headed “Criteria”, paragraph (c))

Omit “renders”, substitute “render”.

7  Subsection 17(1) (table item 5, column headed “Criteria”)

Omit “Either of the following”, substitute “Any of the following”.

8  Subsection 17(1) (at the end of the cell at table item 5, column headed “Criteria”)

Add:

; (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.

9  Subsections 18(3) and (5)

Omit “Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Fifth Edition 2018)”, substitute “Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Sixth Edition 2021)”.

10  Subsection 18(5) (note)

Omit “Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Fifth Edition 2018)”, substitute “Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Sixth Edition 2021)”.

11  At the end of section 18

Add:

             (6)  Paragraph (1)(c) and subsection (4) do not apply to a designated person of a premises that:

                     (a)  comprises a category S laboratory; and

                     (b)  renders services in 1 or more groups of pathology testing that are in 1 or more pathology disciplines with a national workforce shortage.

12  Schedule 1

Omit “NPAAC materials”, substitute:

1  NPAAC materials

                   The following table has effect for the purposes of the definition of accreditation materials in subsection 5(2).

13  Schedule 1 (table item 19)

Repeal the item, substitute:

19

Requirements for Supervision in the Clinical Governance of Medical Pathology Laboratories (Sixth Edition 2021)

2021

14  Schedule 1 (table item 21)

Repeal the item, substitute:

21

Requirements for the Retention of Laboratory Records and Diagnostic Material (Eighth Edition 2021)

2021

15  Schedule 1 (note at the end of the table)

Omit “2018”, substitute “2021”.

16  At the end of Schedule 1

Add:

2  Application of the Requirements for Medical Pathology Services (Third Edition 2018)

Scope

             (1)  This clause applies in relation to a designated person of a premises that:

                     (a)  comprises a category S laboratory; and

                     (b)  renders services in 1 or more groups of pathology testing that are in 1 or more pathology disciplines with a national workforce shortage.

Application

             (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.

Part 2Amendments commencing 1 January 2022

Health Insurance (Accredited Pathology Laboratories—Approval) Principles 2017

17  Schedule 1 (at the end of the table)

Add:

23

Requirements for the Communication of High Risk Pathology Results (First Edition 2020)

2020

Part 3Amendments commencing 1 August 2022

Health Insurance (Accredited Pathology Laboratories—Approval) Principles 2017

18  Schedule 1 (table item 4)

Repeal the item, substitute:

4

Requirements for Information Communication and Reporting (Fourth Edition 2020)

2020