CPA assessment – the regional assessors’ experience

Many individuals within Laboratory Medicine will be unaware that CPA conducts assessments to two different sets of CPA Standards. There are the Standards for the Medical Laboratory and the Standards for EQA Schemes in Laboratory Medicine. The style and format of both sets of standards is very similar with each being presented in eight sections A – H. The EQA standards are almost identical to the laboratory standards with the exception of the E.F and G standards which are specific to EQA schemes. There are approximately 40 EQA Schemes registered with CPA compared with almost 2 500 laboratories. These EQA schemes vary from very large national/international schemes with numerous analytes to small interpretive schemes run by one individual with a personal interest in that specific subject. The large schemes usually come under the UKNEQAS consortia banner and due to their size and configuration do not present undue problems in the assessment process. Smaller interpretive EQA schemes present a challenge both for the scheme and CPA in gaining accreditation. These schemes are usually within the discipline of Histopathology and are regarded as educational rather than proficiency testing schemes. Very frequently, the scheme is organized by a single individual with a collection of microscope slides, storage facilities for the slides and a computer. This presents the Scheme Organizer with great difficulty in complying with the Quality Management System requirements of the CPA Standards. There are a number of models which can be applied in order to satisfy the requirement of the Quality Management System, but ultimately it must be recognized that in some circumstances it is not possible to accredit these small schemes. The NHSCSP Gynae Cytology EQA Scheme is probably the largest EQA scheme within the UK, in respect of the number of participants and the number of staff supporting the scheme. Scheme Management decided that all nine regions of England would apply for accreditation under one CPA Reference Number. This process meant that the scheme would be assessed as a Managed Pathology Network. This is unique in terms of EQA schemes and presented a number of problems not previously encountered in EQA scheme accreditation. This decision meant that all nine regions must comply with a single Quality Management System and other CPA standards whilst allowing flexibility within the system for each region to facilitate the assessment process specific to their user's requirements. The process worked in a satisfactory manner and the overall outcome was not dissimilar to that of other large EQA schemes. The assessment to the current EQA Standards only commenced in April 2006 whilst the Standards for Medical Laboratories commenced in 2003, and it is perhaps not surprising to find that the principal non-conformities are related to the Quality Management System. This parallels the findings encountered in laboratory accreditation. There is an ongoing educational process for Scheme Management and the Facilitators in each region in how to comply fully with the standards and a commitment to quality improvement which ultimately is beneficial to the participant's of the scheme and to patient safety.