EXPLANATORY STATEMENT
HEALTH INSURANCE ACT 1973
SECTION 23DNA
HEALTH INSURANCE (ACCREDITED PATHOLOGY LABORATORIES –
APPROVAL) PRINCIPLES 2007
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 powers under section 23DN of the Act to approve in principle, or not to approve, premises as an accredited pathology laboratory.
Medicare benefits, apart from some basic tests conducted by treating medical practitioners on their own patients, are not payable in respect of pathology services unless they are rendered in an accredited pathology laboratory. The accreditation principles operate to ensure minimum acceptable standards in pathology laboratories. The principles as determined also make reference to National Pathology Accreditation Advisory Council (NPAAC) accreditation documents, which are standards, guidelines and other assessment aids that must be taken into account during the accreditation process. Medicare Australia 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 Australasia (RCPA).
- NPAAC has also endorsed the following revised NPAAC document, which forms part of the Amendments to the Principles (No.3), Schedule 1 Part 1 of the Principles:
Requirements for Supervision of Pathology Laboratories (Revised document)
This document was first published in 1999. It details the standards used to assure the safety, quality and efficacy of pathology testing through effective supervision.
Laboratories have been categorised into groups to facilitate the definition of appropriate levels of supervision for particular types of laboratories. There are five categories of laboratories. These are defined by who is responsible for the day-to-day supervision:
- Category GX (General)
- Category GY (General)
- Category B (Branch)
- Category M (Medical Practice)
- Category S (Specialised).
This document revision was a short, focussed review and was conducted by NPAAC to address specific issues. These included:
a) clarification of the wording to ensure that supervisory obligations for the pathologist are specified for Category GX and GY.
b) clarification of the supervisory obligations in the circumstances of a part-time pathologist as well as for a laboratory operating for less than full-time hours of operation.
The Requirements for the Supervision of Pathology Laboratories (2007) document will be included in the list of accreditation materials, with effect on and after 1 January 2008.
Schedule 2 of the Amendment Principles (No.3) sets out the intended changes and links the inclusion of the revised Supervision document to the Amendment Principles (No.2), which have a commencement date of 1 January 2008.
Consultation
In line with the established NPAAC public consultation and drafting process, the draft document was circulated for comments to:
- all laboratories within Australia
- NPAAC members, including State and Territory representatives
- peak pathology industry and professional organisations
The document was also posted on the NPAAC website.
All submissions from the respective public consultation phases for this document were considered by NPAAC in the finalisation of the document. All issues of concern were resolved through the drafting process and the impact on industry has been assessed as minimal.
2. NPAAC has endorsed the following revised NATA document, which forms part of the Amendments to the Principles (No.3), Schedule 1 Part 2 of the Principles:
AS 4633 (ISO 15189) Field Application Document – Supplementary Requirements for Accreditation in the Field of Medical Testing – published in August 2007.
This document also provides interpretive detail of the NPAAC standards. Technical notes are also available to assist laboratories in relation to particular technical issues.
The first NATA Field Application Document was implemented in 2000 and this will be the fifth edition of the document titled.
This document, known widely as the NATA Field Application Document (FAD), provides an explanation of the applications of ISO 15189 to the various disciplines of pathology testing and also a description of the NATA/RCPA accreditation procedures applied in this field. Medical testing laboratories must comply with this document, all relevant clauses of ISO 15189, the NATA Rules, NPAAC standards and relevant statutory requirements for accreditation to be granted and continued.
The NATA FAD August 2007 document will be included in the list of accreditation materials from the day after the draft Health Insurance (Accredited Pathology Laboratories - Approval) Amendment Principles 2007 (No. 3) (the draft Amendment Principles) are registered. For example, if the draft Amendment Principles are registered on 1 December 2007, the document will be included in the list of accreditation materials on and after 2 December 2007.
Consultation
As part of the NATA document drafting process and public consultation, the NATA FAD August 2007 document was circulated for comment to:
- NATA’s Medical Testing staff and Senior Technical Management
- Medical Testing Accreditation Advisory Committee members (who represent professional societies including the Australian Institute of Medical Scientists (AIMS), Australasian Association of Clinical Biochemists (AACB) and the Australian Society for Microbiology (ASM)
- the Royal College of Pathologists Australasia (RCPA)
- NPAAC members, including State and Territory representatives
- the Document Review and Liaison (DRL) Committee, which is an NPAAC subcommittee.
All submissions from the respective public consultation phases for this document were considered by NPAAC in the finalisation of the document. All issues of concern were resolved through the drafting process and the impact on industry has been assessed as minimal.