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 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 determined accreditation principles operate to ensure minimum acceptable standards in pathology laboratories. The determined principles also make reference to National Pathology Accreditation Advisory Council (NPAAC) documents which are standards, guidelines and other assessment aids that must be taken into account during the accreditation process. The Medicare Australia administers the accreditation process.
NPAAC has endorsed the following revised documents, which are now included in Schedule 1 of the Principles:
1. Requirements for the Retention of Laboratory Records and Diagnostic Material (Revised Document)
This is the fourth edition of the NPAAC Requirements for the Retention of Laboratory Records and Diagnostic Material. Since the revision of the last edition in 2002, there have been significant developments in Australian laboratory practice. All pathology laboratories are required to maintain a formal quality system and must be accredited to AS 4663;2004 (ISO 15189;2003)-Medical laboratories - Particular requirements for quality and competence. In addressing these developments, NPAAC has completely revised the requirements for retention and has adopted principles to create a uniform and integrated approach to retention requirements.
2. Requirements for Cytogenetic Testing (Revised Document)
Cytogenetics is the study of genetic material (chromosomes) at the cellular level. This is the second edition of this document developed by NPAAC and based on guidelines developed by the Human Genetics Society of Australasia (HGSA). This document has been revised to align it with current practices. It is intended to be used in cytogenetic laboratories to provide guidance on good laboratory practice in relation to cytogenetics and by assessors carrying out laboratory accreditation assessments.
3. Requirements for the Packaging and Transport of Pathology Specimens and Associated Materials (Revised Document)
Pathology specimens and associated materials must be transported and packaged in a suitable manner. This is to protect the safety of everyone required to handle the specimens and packages and to ensure material is maintained under suitable conditions to retain specimen integrity for accurate diagnosis. This document has been updated to better assist laboratories preparing policies and procedures for packaging and transportation of specimens.
This document is a compilation of various existing legislative requirements into one easy reference source. It has been developed to incorporate legislative/or obligation of from Australia Post, International Air Transport Association (IATA) and Transport Australia. Initial feedback has noted that it is most helpful to have all transport related obligations listed in one publication.
4. Requirements for Information Communication (Revised Document)
This document was last revised in 1998. In the interim, changes in technology have been significant. To facilitate the secure and private transmission of pathology orders and results, laboratories must be able to ensure the confidentiality, authenticity, integrity and availability of these messages. It has been identified that updated advice on appropriate standards would significantly assist laboratories when upgrading and maintaining Laboratory Information Systems.
The integration of computer systems and telecommunication systems offers faster transfer of pathology requests and reports. This document is designed to guide laboratories in relation to the transfer of pathology data via intra and inter laboratory information systems in a manner that is secure and that preserves the integrity of data.
Many laboratories have sought guidance from NATA regarding problems they have experienced with new information technology systems not delivering results as desired. Third parties are also unclear about the handling of electronic results. The revised requirements now necessitate laboratories to have procedures in place to ensure private information is handled safely to minimise negative impact on patients.
5. Classification of Human Genetic Testing (Supplementary Guideline)
Results from genetic tests can have serious social and personal implications. For some time now, pathology laboratories have suggested that guidance should be available to their staff and requesters as to when patients would benefit from pre-test counselling.
This new document will become a supplementary guide to the already published NPAAC document “Laboratory Accreditation Standards and Guidelines for Nucleic Acid Detection and Analysis (2006). The supplementary guideline provides additional information about aspects of the standards and guidelines, and includes information on decision making regarding pre-testing counselling.
This supplementary guidance expands the existing two Levels of testing, as described in the published 2006 NPAAC document, and allows the requesting practitioner and laboratory staff to know what counselling a patient should require. The majority of requests for genetic testing for diagnostic or medical screening purposes will be Level 1. These tests require the usual degree of pre-test advice and consent. A Level 2 test requires professional genetic counselling and consent.
It is proposed that the next time the full document Laboratory Accreditation Standards and Guidelines for Nucleic Acid Detection and Analysis (2006) is reviewed, this supplementary guide will be incorporated in the appendix of the document.
This amendment also makes a number of minor drafting corrections to the Principles.
Consultation
As part of the established NPAAC public consultation and drafting process, all documents prepared by NPAAC are circulated for comments to:
- all laboratories within Australia
- NPAAC members, including State and Territory representatives
- peak pathology industry and professional organisations
During the public consultation phase, documents are also posted on the NPAAC website.
All submissions from the respective public consultation phases for these five documents were considered by NPAAC in the finalisation of the documents. All issues of concern were resolved through the drafting process and the impact on industry has been assessed as minimal.
Implementation
The revised Principles come into effect on 1 January 2008.