There has been continued development of analytical systems intended for provision of pathology tests outside the laboratory setting. Such systems include low capital cost analysers and also kits which do not require use of instrumentation.

Use of non laboratory pathology testing (NLPT) has become popular in a number of countries, but in Australia less than one per cent of pathology tests for which Medicare reimbursement is claimed are performed outside the laboratory.

Results from studies in Australia and other countries indicate that levels of analytical performance achieved with NLPT can be unacceptable, particularly if appropriate training and quality control measures are not put in place.

Australian data suggest that general practitioner office pathology could result in a net increase in pathology services and increase costs to the health care system.

Pathology laboratory accreditation schemes cover all NLPT laboratory settings, except home testing, in Victoria, and all services for which a Medicare benefit is payable in the rest of Australia. The Panel considers that all NLPT, with the exception of self testing, should be required to meet the accreditation standards developed by the National Pathology Accreditation Advisory Council(NPAAC). This would require State and Territory governments to introduce complementary accreditation provisions.

Educational and quality control programs for non laboratory operators have been developed by the Royal Australian College of General Practitioners in association with the Royal College of Pathologists of Australasia and the Australian Association of Clinical Biochemists. The Panel sees a need for the expansion of suitable educational material for providers of pathology tests who have not had appropriate training.

Application of accreditation provisions to performance of tests using kits may not be appropriate. Assurance of effective performance of such products may require increased attention to manufacturers' quality control linked to testing and assessment by appropriate agencies.

The Panel considers that while NLPT has potential value in improving diagnostic services, its overall benefit in most situations remains unclear and may be marginal.

The Panel recommends that:

  • Accreditation provisions be extended to cover all non-laboratory operators of pathology analysers and that health authorities give consideration to the means of achieving this objective.
  • The NPAAC consider and report on the feasibility and usefulness of accreditation provisions covering the use of diagnostic kits by persons without appropriate training.
  • Mechanisms be established to ensure that' diagnostic kits are tested to determine whether the specifications and label claims are met. The Commonwealth Department of Community Services and Health might consider development of such an approach in association with relevant professional bodies.
  • The NPAAC, the National Association of Testing Authorities, the Royal Australian College of General Practitioners, other relevant professional bodies and equipment manufacturers give continued consideration to the preparation and distribution of educational material for providers of pathology services who have not had appropriate training.
  • Further work is undertaken to obtain measures of the costs and effectiveness of NLPT, and that this area of pathology testing is kept under critical review by professional bodies and health authorities.