Moving towards service accreditation: an update

In a 2007 review of NHS pathology services in England, Lord Carter of Coles noted that accreditation of laboratories was voluntary and that point of care tests in pathology were not covered by the Clinical Pathology Accreditation (CPA) scheme, which is now a subsidiary of the United Kingdom Accreditation Service (UKAS). He called for these issues to be addressed. In a second review, Report of the Second Phase of the Review of NHS Pathology Services in England, published in 2008, Lord Carter found that not much had changed and led him to recommend that the accreditation process should be reviewed. He also recommended that all pathology service providers should be subject to mandatory accreditation, including point of care testing (POCT), giving members of the public and other NHS staff the confidence that the quality of the service has been independently verified as meeting objective service standards.

The review recommendations resulted in clinical laboratories increasingly accrediting to the ISO 15189 standard (Medical Laboratories: particular requirements for quality and competence) which specifies requirements for quality and competence in medical laboratories. The scope of the standard was extended with the publication of ISO 15189:2012 to allow laboratory customers and regulatory authorities to confirm and recognise the competence of medical laboratories. It also placed an increased emphasis on the need for continuous improvement. This version of the standard has brought about a greater understanding of the benefits of accreditation and how it can help laboratories to develop their quality management system and assess their own competence.

Benefits of accreditation
“As laboratories become more familiar with the benefits of accreditation, the ISO standard that relates to POCT – ISO 22870:2006 – is now also starting to receive more focus and there is a drive to bring the quality and competence in POCT up to the same standards as laboratory test processes,” said Dr David Ricketts, a member of the Technical Committee ISO/TC TC 212, clinical laboratory testing and in vitro diagnostic test systems, representing the IBMS, and who was involved in the creation of the standard.