RCPA Supports Recommendations for Pathology Tests in Australia

The Royal College of Pathologists of Australasia (RCPA) has announced its support of a document released today by Friends of Science in Medicine (FSM) surrounding Recommendations for Pathology Tests in Australia.
The report outlines a number of proposed recommendations to ensure the accuracy and reliability of pathology results for diagnosis.  It proposes the implementation of regulations for Non-Medicare funded tests, similar to those already in place for Medicare funded tests, so that they are measured using a set of characteristics:

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  Analytical validity which determines whether the measurement in a test tube accurately reflects the measurement in the patient’s blood/tissue being analysed;


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  Clinical validity which determines whether the test result reflects a significant relationship with the disease in question;


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  Clinical utility which determines whether the test result reveals additional information that is not already available; and


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  Cost-effectiveness of a test, that is, whether the financial cost of the pathology test is justifiable.

President of the RCPA, Professor Yee Khong, explains that these characteristics, which have been used for a long time by pathologists to ensure their work is safe and effective, are vital to appropriate patient care.
“If a patient is making an important health decision based on their pathology results, it is crucial these tests are of absolute accuracy to ensure correct diagnosis,” says Khong.
The report outlines that individuals may choose to have unvalidated tests provided by unaccredited laboratories. However, these tests cannot be regarded as “medical tests” or “pathology tests” as they do not have the analytical validity, clinical validity or clinical utility required of a test to be used for medical purposes.
The report argues that it is both inaccurate and potentially hazardous for an unsubstantiated non-validated test to be regarded in the same category as tests that are substantiated and accredited for medical testing.
“Patients should talk to their GPs and specialists before seeking out any tests that may come from non-accredited laboratories, over the counter, or over the internet, to make sure those tests are providing useful information. Often the patient will be out of pocket and none the wiser. Worse still, they may be misled and act on invalid test results,” says Khong.
Professor Khong explains that specific tests, such as those surrounding genetics, that are not yet Medicare-funded, can be valuable for those who may carry inherited genetic disorders, however, if regulations for these tests are not implemented, there is potential for misuse .
“Genetic testing is a rapidly evolving area. Many of the tests undertaken by accredited laboratories may be clinically valuable, for example, the BRCA 1 and BRCA 2 genes that have been linked to breast cancer. There are, however, many genetic tests that have not yet been assessed for Medicare funding.
“Health practitioners need to be aware of the test characteristics to ensure the patient’s concerns are met, and that the tests being performed are justifiable, avoiding unnecessary patient anxiety,” says Khong.
The full FSM report can be viewed on the FSM website at: www.scienceinmedicine.org.au
For further information on accredited laboratory testing, visit the RCPA website at: www.rcpa.edu.au