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Enhanced pathology laboratory testing standards to protect public health and safety

The Federal Minister for Health and Ageing, Senator Kay Patterson, today announced measures to enhance standards of pathology laboratory testing and identify laboratories that pose a risk to public health and safety.

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29 August 2002

Enhanced pathology laboratory testing standards to protect public health and safety

The Federal Minister for Health and Ageing, Senator Kay Patterson, today announced measures to enhance standards of pathology laboratory testing and identify laboratories that pose a risk to public health and safety.

Spot checks of pathology laboratories, public notification of laboratories which fail to meet standards, and greater sanctions for the Health Insurance Commission to act against non-performing laboratories, are parts of the package to strengthen laboratory accreditation procedures.

Senator Patterson was announcing the Government's response to a comprehensive review of the accreditation arrangements for pathology laboratories.

The report, undertaken by Corrs Chambers Westgarth, found that although accreditation arrangements are fundamentally sound, there are key areas where improvements should be made.

Senator Patterson earlier this year named three pathology laboratories that had failed to perform pap smear testing to the required standard.

She said reforms of pathology laboratory testing, which would be implemented next month, would minimise delays in enforcing sanctions against laboratories that failed to meet the required standard.

The major reforms include:

  • Safety and Quality: The Health Insurance Commission (HIC) will be able to undertake spot checks of laboratories.
  • Early Warning System: The National Association of Testing Authorities (NATA), which assesses laboratories, will get earlier information on poorly performing laboratories. NATA will provide early warning of possible concerns to the HIC.
  • Public Notification System: Up-to-date information about the laboratories' accreditation status on websites letting people know about their performances.
  • Streamlining of Appeals Process: Speeding up the review, action and appeal processes. Quicker and more streamlined appeals process by NATA. HIC can act independently of the NATA appeals process if it has concerns and believes it is in the public interest.
  • Tougher Sanctions: If laboratories fail to meet standards, access to Medicare benefits will be cut.

Senator Patterson said under current arrangements, laboratories which failed testing standards could continue to be eligible for Medicare benefits while they appealed an adverse decision by the National Association of Testing Authorities.

"I have been extremely concerned that when a laboratory has been found to be performing below standard, a convoluted and protracted series of legal and administrative processes has frustrated the public's and doctors' legitimate right to know when a laboratory has failed," she said.

"The Government's ability to remove Medicare funding from these poorly performing laboratories had been impeded.

"The process has been too slow and it has focused on the needs of the pathology services and not enough on the health interests of users of pathology laboratory services.

"Natural justice for laboratories is important, however, the public interest and patients' health and safety must be the main concern. I have moved with these reforms to restore the balance.

"Laboratories that fail will be given 14 days to show cause - if they don't, they will lose their access to Medicare benefits."

Senator Patterson said Medicare provided $1 billion a year for pathology services performed at more than 500 accredited pathology laboratories.

"The vast majority of laboratories perform an excellent job in providing high-quality testing for the Australian public," she said.

"These changes are directed at the small number of laboratories which are not performing to the required standard. These measures will ensure that these laboratories cannot beat the system and they will not survive."

Senator Patterson said the initiatives would ensure that Australia maintained its place as a world leader in pathology testing. In particular, Australia had one of the best early detection programs for cervical screening in the world.

The Federal Government spends $100 million a year through Medicare to support the National Cervical Screening program. Deaths from cervical cancer have fallen by 40% between 1986 and 1998 as the result of the screening program.

Senator Patterson said: "An effective and safe pathology accreditation system is at the very heart for our national screening programs for breast and cervical cancer.

"We are about to run pilot programs to test for bowel cancer to find out if we can introduce a national screening program for the early detection of bowel cancer, which kills about 90 people a week.

"The public can be confident that the reforms I have announced today will make a good system even better and ensure the highest of standards and safety of pathology laboratory accreditation in this country."

Media Contact: Randal Markey, Media Adviser, 0417 694 520