Laboratory Accreditation: the basis for confidence

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Accreditation

CPA UK Ltd was originally formed by the main UK organisations of laboratory professionals to operate a scheme of voluntary accreditation for laboratories. In 2009 CPA became a subsidiary of United Kingdom Accreditation Service (UKAS) as part of a strategy to contribute to the modernisation of pathology services in the UK. As part of this modernisation and development UKAS is currently managing the transition of all CPA accredited laboratories to UKAS accreditation to the internationally recognised standard ISO 15189:2012, Medical Laboratories – particular requirements for quality, competence and the transition of CPA accredited External Quality Assurance Providers (EQA) to ISO/IEC 17043:2010, Conformity Assessment – General requirements for proficiency testing.

Laboratories are currently assessed every 2 years and have to renew their registration every year, confirming that they are continuing to operate in compliance with a set of defined standards. Although the scheme is voluntary, the majority of UK clinical laboratories are currently accredited by the scheme, and the phrase 'UKAS/CPA accredited laboratory' is a guarantee that the laboratory has been assessed and approved as a provider of results which meet accepted standards. More details can be found on the UKAS website, which lists all currently accredited laboratories.

Four particularly important areas for inspection are external quality assessment, internal quality control, standard operating procedures and personnel training/competence assessment.

External quality assessment:

Laboratories performing tests on clinical samples participate in External Quality Assessment (EQA) programmes. In these programmes, an outside organisation checks on the accuracy of a laboratory's test results by sending test specimens to be analysed. The outside organisation knows the results of the tests- the cholesterol concentration, for example - but the laboratory does not. The laboratory must test these specimens in the same way it would test specimens normally and return their result to the EQA co-ordinators. The outside organisation uses these programmes to assess the laboratory’s ability to deliver consistently accurate results, and laboratories with performance problems will receive advice and help to rectify any difficulties. UKAS assessors 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' specimens alongside specimens from patients. The laboratories know the result of the control specimens which act as a built-in check on the process of analysis, which in many cases is carried out on automated equipment. The control specimens contain both high and low values of the test being measured, to make sure that the analyser or procedure is operating correctly across the range of concentrations the patient specimens may contain. If the control results differ from the known, expected result, laboratory staff will immediately know that there is a problem and take action to resolve, before patient results are released. Laboratory assessors also examine these records as part of their evaluations to ensure the action of the laboratory scientists is appropriate.

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 and accurately each time.  Assessors ensure that all Standard Operating Procedures are accessible, regularly reviewed and up-to-date.

Education and Training:

There are many roles to fulfil in a laboratory, and both the professional organisations and the statutory bodies which undertake registration spell out the requirements for education, fitness to practice and training of laboratory personnel.

 

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