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13 August 2003
VICTORIA - THE LEADER IN PATHOLOGY REGULATION
The Victorian Branch of the Australian Institute of Medical Scientists
(AIMS) has expressed its grave concern at the lack of public feedback from
the recent review of the Pathology Services Accreditation Act 1984 and the
rumoured imminent moves by the State Government to repeal this Act. AIMS is
the professional body representing medical scientists working mainly in
hospital and private medical (pathology) laboratories in Australia.
Medical scientists comprise 53% of the staff of the pathology services in
Victoria (pathologists 6.6%, technicians 9.2%, trainee medical scientists
and technicians 0.9%, other medical doctors 3.5%, laboratory assistants
9.3%, blood collectors and couriers 8.8%, nurses 8.5%).
Medical scientists are the third largest professional group in country and
metropolitan hospitals after nurses and doctors.
The repeal of this Act and the Pathology Services Accreditation Board (PSAB)
is strongly opposed by AIMS.
The existing arrangements for accreditation of pathology laboratories in
Victoria are a benchmark for appropriate legislation in other states and any
move to remove the PSAB would have serious adverse effects on healthcare in
this State.
The Commonwealth Department of Health and Ageing published the "Evaluation
of the Australian Pathology Laboratory Accreditation Arrangements" on 17th
July 2002. The executive summary stated that because the Commonwealth has no
direct regulatory power over pathology performance (other than by Medicare
funding) in the States, "Complementary State-based legislation, as currently
applies in Victoria, may be appropriate to regulate these services".
This recommendation was made to address the issue of pathology testing
conducted outside the Medicare provisions of the Health Insurance
Commission, an issue that is of great concern to AIMS and to the profession
generally. Such laboratories are free to operate on a fee for service basis
and are not required to undergo NATA accreditation. Many of these
laboratories support the alternative medicine industry and live blood
analysis, carried out by some naturopaths and sometimes at shopping centres.
The fact that no other State besides Victoria has implemented legislative
controls over pathology services has raised the question in some minds as to
whether State accreditation is required in Victoria - the argument being
that if there really were a need, the other States would have passed similar
legislation. Victoria was the first state to legislate in this case at it
was in the case of legislation (the Chinese Medicine Registration Act 2000)
to control the practice of Chinese medicine. Although some other
jurisdictions are expected to follow suit there can be no certainty of this.
After all, it was decided at a Health Ministers Conference in 1984 that the
Ministers should give priority to the establishment of pathology
accreditation procedures in their respective jurisdictions as soon as
possible. Only Victoria and NSW took up the challenge by enacting
legislation and only Victoria went the full distance and implemented it.
The Chair of the Victorian Branch of AIMS, Associate Professor Alan Turner,
wrote to the Minister, Bronwyn Pike in June pointing out the benefits of the
existing legislation and the leadership role the state has had in this
position.
Loss of the PSAB will lead to some laboratories issuing results of unknown
quality because there are no longer any requirements to be inspected.
If this Act were to be repealed Victorians would be left with only
Commonwealth legislation to regulate pathology. There are two serious
problems with this:
1. The Commonwealth legislation does not apply to all laboratories.
2. The Commonwealth legislation permits unqualified people to perform tests
and issue reports in all laboratories in Victoria.
The major problems anticipated are:
1. There will be some laboratories issuing results of unknown quality
because there are no longer any requirements to be inspected.
2. Unqualified people will be asked to perform tests and interpret and issue
results for which they are not trained. This includes matching of blood
products for transfusion.
3. There will be an influx of alternative medicine tests such as live blood
analysis, DNA testing for viral antigens and digestive stool analysis for
which there is no scientific basis or validation data. These will not
require accreditation.
The Victorian Pathology Services Accreditation Act 1984, as well as setting
a very high standard for pathology services in that State, would appear to
be responsible for the almost complete absence of unregulated alternative
testing in Victoria.
Pathology accreditation legislation applies to the complete spectrum of
pathology testing - from a shopping centre cholesterol test (which may only
be for client curiosity value) to crossmatching blood for an airlifted group
of Bali (or any terrorist attack) victims in a major trauma hospital, or
diagnosing meningococcal disease in a country hospital in the middle of the
night.
The implications that would result from loss of the Victorian legislation
would be diminished requirement that persons performing tests must be
qualified or directly supervised.
This applies to all laboratories, including Medicare rebate claiming labs,
i.e. every laboratory in Victoria. The situation is analogous to having an
unqualified person dispensing drugs in the pharmacy.
In Victoria, we believe that we have the best system in Australia, possibly
the world. Even if the Act is repealed, the State will still be responsible
for all pathology in Victoria. The State will have no vehicle to monitor or
control it. It is not coincidental that there appears to be a complete
absence of unregulated alternative testing, such as live blood analysis, in
Victoria.
The Victorian Branch of AIMS urges the Victorian government to consider the
value of their existing legislation which is a model that other States have
been envious of.
The adverse ramifications of repeal of the Act are extremely serious.
Associate Professor Alan Turner
Chair, Victorian Branch, Australian Institute of Medical Scientists
For further
information contact:
Alan Turner
Associate Professor of Haematology
Haematology Discipline Leader
Masters in Medical Science Program Coordinator
Chair, Victorian Branch, Australian Institute of Medical Scientists
Division of Laboratory Medicine, School of Medical Sciences
RMIT University, Bundoora Campus
PO Box 71, Bundoora 3083
Melbourne, Victoria,
Australia
Web Site: www.rmit.edu.au/medical-sciences/
Telephone 9925 7068
International +61 3 99257068
Fax 61 3 9925 7063
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