EXPLANATORY STATEMENT
HEALTH INSURANCE ACT 1973
SECTION 23DNA
HEALTH INSURANCE (ACCREDITED PATHOLOGY LABORATORIES –
APPROVAL) AMENDMENT PRINCIPLES 2008
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 endorsed the following new NPAAC document, which forms part of the Amendments to the Principles 2008 (No.1), Schedule 1 Part 1 of the Principles:
- Requirements for Transfusion Laboratory Practice
The “Requirements for Transfusion Laboratory Practice” is a new NPAAC document. It is based on the recently released Australian and New Zealand Society of Blood Transfusion (ANZSBT) Guidelines for Pretransfusion Laboratory Practice (2007) and incorporates the essential elements of the ANZSBT Guidelines for Blood Grouping and Antibody Screening in Antenatal and Perinatal Settings (2007).
All transfusion laboratories operating in Australia are currently complying with the ANZSBT Guidelines and are assessed by NATA using these Guidelines and other relevant NPAAC Standards. Therefore whilst the adoption of these Guidelines will bring them into force as mandatory NPAAC requirements, their inclusion is expected to have minimal impact on stakeholders as there will be no change to current practice required.
The NPAAC document Requirements for Transfusion Laboratory Practice (2008) will be included in the list of accreditation materials, with an effect date of 1 October 2008.
A copy of the Requirements for Transfusion Laboratory Practice document is available on the NPAAC website – www.health.gov.au/npaac
Consultation
In accordance 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.
Submissions from the public consultation phase 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, given the current level of compliance with the existing ANZSBT Guidelines.