Inspections

Laboratories are inspected at regular intervals to make sure they are following the requirements established by CPA. Four particularly important areas for inspection are external quality assessment, internal quality control, standard operating procedures and personnel training.

External quality assessment: Laboratories performing tests on clinical samples participate in External Quality Assessment (EQA) programmes. In these programmes, an outside agency approved by CPA checks on the accuracy of a laboratory's test results by sending test samples to be analysed. The outside agency knows the levels of the substances (analytes) contained in the samples - the cholesterol level, for example - but the laboratory does not. The laboratory must test the samples in the same way it would test specimens from patients. The outside agency uses these programmes to assess the laboratory’s ability to deliver consistently accurate results, and laboratories with performance problems will receive warnings and help to rectify any difficulties. CPA inspectors will verify that the laboratory shows acceptable performance in approved EQA schemes.

Internal quality control: To ensure that the results being issued by the laboratory are correct, 24 hours a day, 7 days a week, clinical laboratories test 'control' samples alongside samples from patients. The laboratories know exactly what these control samples contain, so the samples act as a built-in check on the process of analysis, which in many cases is carried out on automatic equipment called an analyzer. The control samples contain both high and low concentrations of the analyte being measured, to make sure that the analyser or procedure is operating correctly across the range of concentrations the patient samples may contain. If the control results vary from the known quantities, laboratory staff immediately know that there is a problem. Laboratory inspectors also examine these records as part of their evaluations.

Standard Operating Procedures: Every test or process carried out in a laboratory must have a Standard Operating Procedure, which is a defined way of performing a specific course of action. Standard Operating Procedures help to ensure that every process is carried out consistently each time, no matter who actually performs it. Inspectors ensure that all Standard Operating Procedures are accessible and up-to-date.

Education and Training: There are many roles to fulfil in a laboratory, and both the professional organizations and the statutory bodies which undertake registration spell out the requirements for education and training of laboratory personnel. The scientists and doctors who work in laboratories must be registered professionals, who are appropriately qualified for the tasks they perform and who adhere to strict codes of conduct and ethics.