In-house diagnostic pathology and pathology referrals Review of existing policy ratified October 2000 Policy Veterinarians offering in-house diagnostic pathology services should ensure that equipment and services are subject to regular quality control and quality assurance testing. Staff should be thoroughly trained in the correct use and routine maintenance of diagnostic equipment. When interpreting the results, staff should be aware of the limitations and interferences that may affect the test results. Background Many veterinary practices use in-house clinical pathology, haematology and cytology equipment to offer a range of diagnostic and treatment monitoring services to their clients. When veterinarians are choosing pathology services or instrumentation, they need to be aware of two concepts: quality control (QC) and quality assurance (QA). QC is the regular processing of a sample with known values (reference values) to monitor the repeatability of the result. The equipment manufacturer or agent often provide QC samples; however, the National Association of Testing Authorities (NATA) recommends independent controls wherever possible. Results are recorded against an expected range, and abnormal results are used to help detect problems with instruments, reagents or operators. Patient samples should not be run and reported until QC results have met expected values. QA is the regular testing of samples with unknown values to test for accuracy. QA is provided by independent testing organisations or may be as simple as sample exchange programs between practices and laboratories. It includes determining consensus values derived by comparing the results of all participants using similar test methodology and equipment. Aberrant QA results may highlight problems with equipment, training or reagents that warrant further investigation. Guidelines General considerations The offering of in-house diagnostic pathology testing to clients where appropriate is considered ‘good veterinary practice’. The judgment of the attending veterinarian about the need for pathology testing and the particular pathology tests used in an investigation or work-up will vary with each clinical situation or circumstance. A higher standard of competency in the interpretation of pathology results is expected from specialist veterinary pathologists when using veterinary pathology services. Failure to practise adequate QC and QA may lead to inaccurate and unconfirmed results. The use of invalidated test results to make judgments on the disease status and prognosis of animal patients could place the veterinarian at risk of making incorrect diagnosis and treatment options and could result in legal action. Results may be inaccurate or invalid if the instruments used have not been validated for samples from the common animal species tested or are tested on incorrect sample types or inappropriately stored and handled samples. Errors can be incorporated into the testing system as a result of many staff members (both lay and professional) using the equipment; this can lead to variability in testing procedures and their results. Precise, thorough and uniform training of staff on the correct use of diagnostic equipment is essential. This must include maintenance, troubleshooting, QC and correct sample handling. Ongoing competency to perform testing must also be assured. Qualified personnel must regularly maintain the equipment used. Features of particular areas of diagnostic pathology Biochemistry All practices using in-house biochemistry equipment should undertake regular QC testing, at intervals appropriate to the equipment being used. The QC material should be appropriate and have reference values pertinent to the equipment being used and the species being tested and cover the range of results likely to be encountered. QC data should be checked against the expected range and the results acted upon before any diagnostic samples are tested. Where possible, internal QC tests should be supplemented with an external QA program. Reagents and QC material should be stored under appropriate conditions. Expired reagents must not be used for diagnostic purposes. Haematology The practice should use haematology QC material that is appropriate for the equipment being used. The QC material should have reference values pertinent to the equipment used. In-house haematology and biochemistry equipment should have QC run on a daily basis. Blood films should be made, stained and examined by a veterinarian on all primary diagnostic cases. Cytology and other microscopic examinations The practitioner must be aware of the potential value and accuracy of techniques involving microscopic examination (fine needle aspirates, impression smears, tape preparations and skin scrapings). This includes the pitfalls and shortcomings associated with sample preparation and examination. Cytology staining solutions should be regularly replaced. Duplicate samples for diagnosis may be submitted to a commercial laboratory as a means of internal QC. Parasitology The preparation of suitable samples is critical to the accuracy and interpretation of findings. Microbiology The accuracy and interpretation of findings from in-house microbiology work is very important. The incubation process, storage procedures, inoculation procedures and materials must be appropriate and valid. Duplicate samples for identification or sensitivity testing may be submitted to a commercial laboratory as a means of internal QC. Serology Negative and positive controls should be run with all diagnostic samples. Such controls are often an inbuilt component of the test system. Urinalysis The diagnostic requirement for a complete or partial urine analysis needs to be considered in each clinical situation. The value of a particular in-house urine analysis procedure – dipstick, specific gravity (refractometer) or microscopic examination of centrifuged urine – needs to be weighed against the value of a complete analysis available at a veterinary pathology laboratory. Necropsy A necropsy should be offered to a client if the information gained could aid in the diagnosis or treatment of a wider disease situation, or in the event of an unexpected or untimely death of an animal. An autopsy may also be appropriate where the client or veterinarian require peace of mind. The owner should be given the option of deciding who will perform the necropsy: the attending veterinarian, a colleague or an independent veterinary pathology laboratory. Necropsy should not be performed without the owner’s consent. Clients should be offered a complete autopsy to ensure that maximum diagnostic information can be gathered. Appropriate diagnostic specimens should be taken from all autopsies and stored for future reference. Pathology referrals Veterinarians are referred to the Australian Veterinary Association’s (AVA’s) policy on veterinary referrals. There are three possible avenues for referral of veterinary clinical pathology and diagnostic tests: commercial, university and government veterinary pathology laboratories medical pathology laboratories, preferably with veterinary accreditation neighbouring practices with appropriate equipment. All commercial and government veterinary pathology laboratories that perform referral testing should be accredited to ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories. Accreditation provides independent assessment of technical competence to perform a range of testing activities. Refer to the NATA (nata.com.au) for a complete listing of accredited veterinary facilities. If the practitioner has a choice of commercial pathology laboratories, an accredited laboratory should be used in preference to an unaccredited laboratory. Referring veterinarians need to be aware that medical pathology laboratories may not be adequately set up for handling veterinary testing samples or have the appropriate expertise to understand the limitations and interpret the results obtained. Practitioners who refer clinical pathology to neighbouring practices must be aware of and accept the QA and QC of the testing performed by that practice. Practitioners who accept referral of clinical pathology from a neighbouring practice must accept responsibility for the results generated by their equipment. Consideration should be given to seeking accreditation for the services provided in-house, as per accredited referral laboratories. Pathology samples for referral must be collected, stored and handled correctly to optimise the value of the test results. Samples must be packaged and transported to the referral laboratory in accordance with any current legislative or industry requirements. Other relevant policies or position statements 6.9 Provision of blood supplies for use in dogs and cats 17.1 Veterinary referrals