Regulation of Non HIC Funded Pathology Services


Pathology services comprise an important and integral component of health care delivery to the community by providing an extensive range of analytical tests on body fluids and tissues to facilitate diagnosis and treatment of a multitude of clinical conditions.
The standards of practise of pathology laboratories are indirectly regulated through the HIC Medicare provisions which require laboratories to be accredited under the NPAAC standards administered by the NATA for the range of tests offered in order to receive rebates for those tests. Under these arrangements, laboratories can avoid any accreditation requirement by operating on a fee for service basis.

Recent reviews of current accreditation arrangements for pathology services have recognised this loophole in the current provisions. The Evaluation of the Australian Pathology Laboratory Accreditation Arrangements (Corrs Report) released in July 2002 identified the need to examine this matter. Recommendation 2.2 of the report stated " That the DHA, in partnership with State and Territory health authorities, undertakes a detailed evaluation of the need for, and potential costs and benefits of, additional legislation in all jurisdictions to complement the Australian pathology laboratory accreditation arrangements." In its response to the report the Commonwealth government agreed to this recommendation.

The Victorian government has until recently been the only state to have pathology services legislation which has applied regulated standards to all pathology providers in that state. The outcome of a review of the Pathology Services Accreditation Act 1984 in that state was the key decision to repeal the Act. That decision was primarily driven by the perception that the state accreditation system duplicated that administered by the NATA. The repeal of the PSAA in Victoria effective from the end of 2003, leaves non HIC funded laboratories and non accredited tests conducted by accredited laboratories without any regulatory oversight in that state also. This has been recognised by the Victorian government's decision to support Recommendation 2.2 of the Corrs report.

Community Screening Services

The Victorian review considered that the accreditation requirements of the PSAA were anti competitive and not required for screening services carried out by various community organisations. A number of "exempted tests" were provided for within the legislation. While there was debate about which tests should be exempt from accreditation, the view of the protagonists for an expanded range was that these would be used for screening and abnormal results could be confirmed in a pathology laboratory. Such an approach runs the risk of creating unnecessary confirmatory testing if erroneous results are generated from unaccredited testing. Screening tests eg. for cholesterol, are conducted in various settings including shopping centres, pharmacies, and by various personnel without any laboratory testing background. Members of the public found to have an abnormal screening test result from community screening which is subsequently not confirmed by laboratory testing, may lose confidence in screening exercises to the ultimate detriment of public health.
Community screening should ideally be conducted as controlled government funded exercises with appropriate quality assurance processes and under the supervision of appropriately trained personnel.

Pathology Testing and the Alternative Medicine Industry

There is a range of diagnostic procedures conducted by and/or supporting the alternative/complementary medicine industry. Many of these services operate outside the NATA accreditation arrangements. While some of these procedures are conventional techniques similar to those conducted in accredited pathology laboratories, there are other procedures not recognised or conducted by accredited laboratories. Haemaview, or live blood analysis, is one such test, which is carried out by placing a drop of blood from the patient's finger on a microscope slide under a glass cover slip. The slide is then viewed at high magnification with a microscope that forwards the image to a television monitor for viewing by both patient and practitioner. The results may then be used as a basis for prescribing dietary supplements.
Since there is no external regulation of such tests, their reliability, validity and accuracy may be variable and is at least open to question. In some states these tests are offered in pharmacies. The nexus between the screening test and the prescribing and supply of complementary medicines by the same practitioner when there is no external validation process for the screening test gives rise to, at the very least, concerns over a conflict of interest. Adequate validation and quality assurance procedures should be in place for all testing wherever, and for whatever purpose, it is conducted. This is of particular concern in cases where the sale of complementary medicines is linked to the results of such tests.
The Report of the Expert Committee on Complementary Medicines in the Health System initiated subsequent to the Pan pharmaceutical revelations, has recommended regulation of the products and providers of the products in the complementary medicine industry. The logical corollary to the legislative steps being proposed to control the quality of these products and their provision, is to similarly provide for quality oversight of the tests conducted which provide the basis for prescribing many of these medicines.

Point of Care Testing

The progressive development and improvement of point of care instruments has expanded the role of this equipment for community based management of patients especially diabetics and those on anticoagulants. In order to ensure consistent accuracy of testing, validation of equipment performance should be done on a regular basis at an accredited pathology laboratory. In addition, medical laboratory scientists should be involved in the training of personnel using these devices.
The AIMS recommends that complementary legislation addressing currently unregulated pathology testing incorporates arrangements to include mechanisms for ongoing validation of point of care testing equipment and of test outcomes.

Complementary Legislation

The most effective mechanisms by which non accredited pathology operations could be regulated remain the subject of discussion. It is important that there be uniformity in approach between states. The creation of template legislation for this purpose may therefore be a suitable approach as a means of providing complementary regulation.
The existing Commonwealth arrangements for laboratory accreditation through NATA are accepted as being effective in raising and maintaining high standards of pathology practice. The obstacle to universality of these arrangements is the legislated link to Medicare. While complementary legislation in the states may be developed to address the issue of non accredited laboratories, it would seem worthwhile considering amendments to the commonwealth legislation to extend the jurisdiction of the NATA arrangements to all pathology services. Complementary state legislation that would then "close the loop" could be formulated along the lines of a recommendation from the Victorian PSAA review whereby it could be a ground for misconduct for a medical practitioner to act on a result from a non accredited pathology service, but extending this to include complementary medicine practitioners.

The results of pathology tests have been estimated to influence approximately 70% of health care decisions. It is a core element of quality health care delivery to the community. It is therefore surely unacceptable that, in our society, some pathology testing services can escape any regulatory oversight by simply operating on a fee for service basis.

The AIMS commends the cooperation being expressed between the Commonwealth and the states in examining this matter and trusts that an outcome that satisfactorily addresses the current deficiencies will be achieved.