EXPLANATORY STATEMENT
HEALTH INSURANCE ACT 1973
SECTION 23DNA
HEALTH INSURANCE (ACCREDITED PATHOLOGY LABORATORIES – APPROVAL) AMENDMENT PRINCIPLES 2012 (NO. 1)
Section 23DNA of the Health Insurance Act 1973 (‘the Act’) provides for the Minister to determine the principles to be applied by the Minister in exercising his or her powers under Section 23DN of the Act to approve in principle, or refuse to approve, premises as an accredited pathology laboratory. The current principles determined under Section 23DNA are the Health Insurance (Accredited Pathology Laboratories – Approval) Principles 2002 as amended (‘the Principles’).
Aside from some basic tests conducted by medical practitioners on their own patients or on patients of practitioners within their own medical practice, Medicare benefits for pathology services are only payable when they are rendered in an accredited pathology laboratory. The Principles operate to ensure minimum acceptable standards in pathology laboratories. The Principles make reference to accreditation materials (National Pathology Accreditation Advisory Council (‘NPAAC’) materials and other materials), which are standards, guidelines and other assessment aids that must be taken into account during the accreditation process. The Department of Human Services administers the accreditation process and the National Association of Testing Authorities, Australia (‘NATA’) conducts the accreditation assessment, in conjunction with the Royal College of Pathologists of Australasia (‘RCPA’).
The purpose of this Instrument is to amend the Health Insurance (Accredited Pathology Laboratories-Approval) Principles 2002 to incorporate the revised accreditation materials that have been endorsed by the National Pathology Accreditation Advisory Council. These quality standards have been revised to be more comprehensive and reflect current best pathology practice.
NPAAC has recently endorsed the following documents, which are revised versions of the accreditation documents currently listed in Schedule 1 to the Principles:
- Guidelines for Approved Pathology Collection Centres (Second Edition 2012)
- Requirements for the Performance of Anatomical Pathology Cut-Up (Third Edition 2012)
- Requirements for Medical Testing of Human Nucleic Acids (First Edition 2012)
- Requirements for Medical Testing of Microbial Nucleic Acids (First Edition 2012)
- Interpretation of NPAAC Requirements and ISO 15189 Medical Testing Field Application Document – Requirements for Accreditation, July 2012
The Health Insurance (Accredited Pathology Laboratories – Approval) Amendment Principles 2012 (No. 1) (‘the Amending Principles’) amend Schedule 1 to the Principles to refer to the above revised documents.
Details of the Amending Principles are set out in the Attachment.
CONSULTATION
- Guidelines for Approved Pathology Collection Centres (Second Edition 2012)
In accordance with the established NPAAC public consultation and drafting process, the draft revised Guidelines for Approved Pathology Collection Centres (Second Edition 2012) were circulated for comments to:
- all laboratories and pathology professional organisations within Australia;
- state and territory health departments; and,
- NPAAC members, including state and territory representatives.
The draft document was released for two rounds of public consultation. An initial draft revision of the document was released for public consultation in mid June 2009. A revised draft revision of the document was released for public consultation in November 2010, with the document providing a stronger focus on known key risk issues associated with the collection of specimens, as well as further clarification on the requirements for best practice for all specimen collection centres.
Submissions from both public consultation phases for this draft document were considered by NPAAC in the finalisation of the document. Feedback from stakeholders has been supportive of the proposed requirements. The revised Guidelines supersede the current Guidelines but do not contain any new requirements that would have associated additional compliance costs.
The Office of Best Practice Regulation (OBPR) has confirmed that the proposed amendments do not require a Regulation Impact Statement (OBPR Reference Number 13532).
ii. Requirements for the Performance of Anatomical Pathology Cut-Up (Third Edition 2012)
In accordance with the established NPAAC public consultation and drafting process, the draft document Requirements for the Performance of Anatomical Pathology Cut-Up (Third Edition 2012) was circulated for comments to:
- all laboratories and pathology professional organisations within Australia;
- state and territory health departments; and,
- NPAAC members, including state and territory representatives.
Requirements for the Performance of Anatomical Pathology Cut-Up (Third Edition 2012) was released for three rounds of public consultation. All of the submissions from the public consultation rounds were considered by NPAAC in the finalisation of the document. Feedback from stakeholders has been overall supportive of the proposed requirements. The revised Requirements supersede the current Guidelines and are more comprehensive but do not include any new requirements that would have an additional compliance cost.
The Office of Best Practice Regulation has confirmed that the proposed amendments do not require a Regulation Impact Statement (OBPR Reference Number 13532).
iii. Requirements for Medical Testing of Human Nucleic Acids (First Edition 2012)
In accordance with the established NPAAC public consultation and drafting process, the draft document Requirements for Medical Testing of Human Nucleic Acids (First Edition 2012) was circulated for comments to:
- all laboratories and pathology professional organisations within Australia;
- state and territory health departments; and,
- NPAAC members, including state and territory representatives.
Submissions from the public consultation phase for this draft document were considered by NPAAC in the finalisation of the document. Feedback from stakeholders has been supportive of the proposed requirements. The revised Requirements supersede the current Requirements but do not contain any new requirements that would have an additional compliance cost.
The Office of Best Practice Regulation has confirmed that the proposed amendments do not require a Regulation Impact Statement (OBPR reference number 13532).
iv. Requirements for Medical Testing of Microbial Nucleic Acids (First Edition 2012)
In accordance with the established NPAAC public consultation and drafting process, the draft document Requirements for Medical Testing of Microbial Nucleic Acids (First Edition 2012) was circulated for comments to:
- all laboratories and pathology professional organisations within Australia;
- state and territory health departments; and,
- NPAAC members, including state and territory representatives.
Submissions from the public consultation phase for this draft document were considered by NPAAC in the finalisation of the document. Feedback from stakeholders has been supportive of the proposed requirements. The revised Requirements supersede the current Requirements but do not contain any new requirements that would have an additional compliance cost.
The Office of Best Practice Regulation has confirmed that the proposed amendments do not require a Regulation Impact Statement (OBPR reference number 13532).
v. National Association of Testing Authorities Field Application Document
The document National Association of Testing Authorities, Australia AS 4633 (ISO 15189) Field Application Document – Supplementary Requirements for Accreditation in the Field of Medical Testing, July 2009 has been reviewed by members of the –
- NATA Medical Testing Accreditation Advisory Committee
- Royal College of Pathologists Australasia; and
- NPAAC, including state and territory representatives.
The document incorporates comments from those expert groups and was endorsed by NPAAC at its 27 October 2011 meeting with an implementation date of 1 July 2012.
The Office of Best Practice Regulation has confirmed that the proposed NATA Field Application Document does not require a Regulation Impact Statement (OBPR reference number 13532).
The Amending Principles commence on 1 July 2012.
The Amending Principles are a legislative instrument for the purposes of the Legislative Instruments Act 2003.
ATTACHMENT
Details of the Health Insurance (Accredited Pathology Laboratories – Approval) Amendment Principles 2012 (No. 1)
- Name of Principles
This section provides that the title of the amending instrument is the Health Insurance (Accredited Pathology Laboratories – Approval) Amendment Principles 2012 (No. 1) (‘Amending Principles’).
2. Commencement
This section provides that the Principles commence on 1 July 2012
3. Amendment of Health Insurance (Accredited Pathology Laboratories – Approval) Principles 2002
This section sets out the amendments to Parts 1 and 2 of Schedule 1 of the Health Insurance (Accredited Pathology Laboratories – Approval) Principles 2002.
SCHEDULE 1 AMENDMENTS COMMENCING 1 JULY 2012
Item 1
Table Item 4 of Part 1, Schedule 1 to the Health Insurance (Accredited Pathology Laboratories – Approval) Principles 2002 (‘the Principles’) currently lists the following document as accreditation material (‘NPAAC material’):
Guidelines for Approved Pathology Collection Centres, published in 2006 (‘the Guidelines’)
The Guidelines has recently been revised and is now the ‘Guidelines for Approved Pathology Collection Centres (Second Edition 2012)’.
While the title has essentially remained the same, the document has been revised to reflect current best practice for all specimen collection. The title still uses the word “Guidelines” because of potential amendments to references within other legislation, including primary legislation.
Item 1 of Schedule 1 to the Amending Principles replaces the reference to the Guidelines with a reference to the revised Guidelines for Approved Pathology Collection Centres (Second Edition 2012).
The Guidelines for Approved Pathology Collection Centres (Second Edition 2012) apply to the management of specimen collection. They form the minimum requirements for best practice for all the premises and operation of pathology collection centres including those operated as Approved Collection Centres, Hospital Collection Points or any other collection facility managed or maintained by a pathology provider. The revised Guidelines outline the requirements that assure the safety, quality and efficacy of the collection of specimens for the testing in pathology laboratories.
A copy of the Guidelines for Approved Pathology Collection Centres (Second Edition 2012) will be available on the NPAAC website at www.health.gov.au/npaac.
An assessment has been completed for Guidelines for Approved Pathology Collection Centres (Second Edition 2012) and the document has been assessed as having low or nil impact and no additional compliance costs.
Item 2
Table Item 5 of Part 1, Schedule 1 to the Principles currently lists the following document as NPAAC material.
Guidelines for the Performance of the Pathology Surgical Cut-Up, published in 2006 (‘the Guidelines’).
The Guidelines has been revised and renamed and is now the Requirements for the Performance of Anatomical Pathology Cut-Up (Third Edition 2012) (‘the Requirements of Pathology Cut-Up’).
Item 2 of Schedule 1 to the Amending Principles replaces the reference to the Guidelines with a reference to the Requirements of Pathology Cut-Up.
The Requirements of Pathology Cut-Up outlines the standards and guidelines for the training and performance of the anatomical pathology cut-up. The document specifies who is permitted to perform the cut-up, the different types of specimens and under what degree of supervision. It recognises that cut-up can be performed by persons other than pathologists and sets out an appropriate framework of protocols to ensure the appropriate training and supervision are provided by anatomical pathology laboratories to ensure safety.
A copy of the Requirements for Pathology Cut-Up will be available on the NPAAC website – www.health.gov.au/npaac.
An assessment has been completed for Requirements for Pathology Cut-Up and the document has been assessed as having low or nil impact and no additional compliance costs.
Item 3
Table Item 7 of Part 1, Schedule 1 to the Principles currently lists the following document as NPAAC material:
Laboratory Accreditation Standards and Guidelines for Nucleic Acid Detection and Analysis, published in 2006 (‘the Standards and Guidelines for Nucleic Acid Detection and Analysis’)
The Standards and Guidelines for Nucleic Acid Detection and Analysis has been revised and renamed and is now the Requirements for Medical Testing of Human Nucleic Acids (First Edition 2012) (‘Requirements for Human Nucleic Acid Detection’); and
Item 3 of Schedule 1 to the Amending Principles replaces the reference to the Standards and Guidelines with a reference to the Requirements for Human Nucleic Acid Detection.
The Requirements for Human Nucleic Acid Detection sets out the standards and guidelines intended to apply for heritable and non-heritable nucleic acid variants associated with human genetic conditions. These tests involve the detection, characterisation and quantification of nucleic acids.
A copy of the Requirements for Human Nucleic Acid Detection will be available on the NPAAC website – www.health.gov.au/npaac.
An assessment has been completed for the Requirements for Human Nucleic Acid Detection and the document has been assessed as having low or nil impact and no additional compliance costs.
Item 4
Table Item 12 of Part 1, Schedule 1 to the Principles currently lists the following document as NPAAC material:
Classification of Human Genetic Testing, published in 2007 (‘the Classification’).
The Classification has been revised and renamed and is now Requirements for Medical Testing of Microbial Nucleic Acids (First Edition 2012) (‘Requirements for Microbial Nucleic Acid Detection’).
Item 4 of Schedule 1 to the Amending Principles replaces the reference to the Classification with a reference to the Requirements for Microbial Nucleic Acid Detection.
The Requirements for Microbial Nucleic Acid Detection outlines the standards and guidelines for tests that are used for the detection, characterisation and quantification of nucleic acids in medical laboratories testing for micro organisms that can or may cause disease in humans.
A copy of the Requirements for Microbial Nucleic Acid Detection will be available on the NPAAC website – www.health.gov.au/npaac.
An assessment has been completed for the Requirements for Microbial Nucleic Acid Detection and the document has been assessed as having low or nil impact and no additional compliance costs.
Item 5
The heading in Schedule 1, Part 2 to the Principles refers to ‘Part 2 Other materials.’ The reference to ‘Other materials’ will be replaced with ‘Supplementary materials.’ The accreditation material listed under Part 2 is an additional resource for NATA to use when preparing its assessment report in accordance with the Principles.
Schedule 1, Part 2 currently lists the following document as accreditation material under the heading ‘Other materials’:
‘National Association of Testing Authorities, Australia AS 4633 (ISO 15189) Field Application Document – Supplementary Requirements for Accreditation in the Field of Medical Testing, July 2009’ (‘the current NATA Field Application Document’).
The current NATA Field Application Document has recently been revised and is now the ‘Interpretation of NPAAC Requirements and ISO 15189 Medical Testing Field Application Document - Requirements for Accreditation, July 2012’ (‘the revised NATA Field Application Document’).
Item 5 of Schedule 1 to the Amending Principles also replaces the reference to the current NATA Field Application Document with a reference to the revised NATA Field Application Document.
This means that the revised NATA Field Application Document will be included in the list of supplementary accreditation materials on and from 1 July 2012.
The NATA Field Application Document is developed by NATA and provides interpretive detail of the NPAAC standards and guidance for the quality and competence of medical testing, in particular an explanation of the applications of ISO 15189: 2003 Medical laboratories – Particular requirements for quality and competence (ISO 15189) to the various disciplines of pathology testing and also a description of the NATA/RCPA accreditation procedures applied in this field. However, for the purposes of accreditation, pathology laboratories must meet the quality standards developed by NPAAC in Part 1 of the Schedule.
The NATA Field Application Document is reviewed every two years to ensure that the document reflects the current best practice and applications of ISO 15189. To ensure transparency of the independent assessing body’s assessment tool and that pathology laboratories are aware of expectations, the document is included in Schedule 1, Part 2 to the Principles.
A copy of the revised NATA Field Application Document will be available on the NATA website – www.nata.asn.au
The changes made to the current NATA Field Application Document have been assessed as being low or nil impact and no additional compliance costs.