- An overview is presented of the dry chemistry pathology trial, which evaluated the use of five clinical chemistry analysers in general practices and hospital ward side-rooms, following initial appraisal of analyser performance by a pathology laboratory.
- Common themes in the general practice and hospital ward side-room studies were the unsatisfactory levels of analytical performance achieved, lack of appreciation of the need to perform quality control procedures, the need for suitable training and education of non-laboratory operators of dry chemistry pathology equipment and the significant demands on the coordinating laboratories.
- Dry chemistry pathology testing carried out by general practices in the trial was additive, overall, to tests requested by the practices from pathology laboratories. Effects on patient outcome, as measured by clinical chemistry indicators, were inconclusive for three of four selected conditions. Further work is needed to define the overall costs and benefits of this technology in general practice.
- Details are given of the experiences of the coordinating laboratories, with particular emphasis on support provided by them for non-laboratory operators, quality control, responsibilities of manufacturers, and responsibilities of 'office laboratories'.
The Working Party recommends that:
- Preparation of educational programs for office pathology workers, such as those developed by the Royal Australian College of General Practitioners, be undertaken by relevant professional bodies.
- The National Pathology Accreditation Advisory Council (NPAAC), the National Association of Testing Authorities and equipment manufacture give continued consideration to the provision and distribution of such educational material.
- Accreditation of services operating dry chemistry pathology analysers should be mandatory.
- In regard to future arrangements for accreditation of non-laboratory pathology services:
- governments should take action to extend the coverage of existing pathology laboratory accreditation requirements to cover all operators of dry chemistry pathology equipment;
- cost and effectiveness of accreditation programs for office pathology be kept under review by health authorities, and NPAAC;
- the feasibility and suitability of applying accreditation to use of other pathology technologies in the non-laboratory situation be considered by NPAAC.
- Users and potential users of dry chemistry pathology critically consider the value and cost of this type of technology.
- A further study be undertaken to assess the usage of dry chemistry pathology and other relevant technology by accredited general practices and its effects on the health status of patients. Further, more extensive, study of the costs and effectiveness of dry chemistry pathology testing in hospital wards would also be desirable.
- Manufacturers and quality assurance program organisers make available suitable quality control material for non-laboratory pathology services which is in liquid form, appropriately packaged and compatible with dry chemistry pathology technology.
- The NPAAC consider means of overcoming current impediments to the use of pathology services as mentor laboratories to provide sources of advice and support for non-laboratory testing.
- Unions, government agencies, professional bodies and administrators consider and discuss effects of non-laboratory testing on employment conditions for laboratory staff.
- The assessment of the safety and efficacy of analytical systems for non-laboratory use be given consideration by relevant government organisations and professional bodies.