Laboratory Quality Control and Accreditation

Abstract

According to the International Organization for Standardization (ISO), the ‘Medical laboratories—Requirements for quality and competence (ISO 15189:2012) BS EN ISO 15189:2012’ accreditation is defined as ‘a procedure by which an authoritative body gives formal recognition that an organization is competent to carry out specific tasks’. Accreditation is delivered by the ‘competent authority’ based on a set of defined standards and the continual internal audit of the laboratory processes and infrastructure against these standards to achieve conformance. Additionally, the ‘competent authority’ periodically undertakes assessments to ensure compliance with the standards. These assessments vary in frequency and nature depending upon the assessment body. In some instances (e.g. UK Accreditation Service, UKAS), the assessments are annual and based on a four- year cycle covering the whole laboratory repertoire and infrastructure. The HSE is responsible for the inspection and licencing of microbiological containment level 3 and 4 facilities. The HTA is responsible for legal registration of laboratories that process and store human tissue, and is mainly histology related. The MHRA provides guidelines on good laboratory practice, good clinical practice, good clinical laboratory practice, and good manufacturing practice, largely around clinical trial work. It is also responsible for accreditation of blood transfusion laboratories. Finally, it provides guidance on the In Vitro Diagnostic Medical Device Directive (IVDMDD, 98/ 79/ EC) and the regulation of medical ‘devices’ including diagnostic devices, where a ‘device’ is defined as including reagent kits and analytical platforms. EFI provides guidance and standards for transplantation and tissue typing laboratories across Europe. Until 2009, CPA provided accreditation for the majority of UK pathology services. CPA was acquired by the UK Accreditation Service in 2009. UKAS is a government- appointed national accreditation body for the UK that is responsible for certification, testing, inspection, and calibration services, and is the competent authority for all ISO standards, not just pathology. It covers various sectors, including healthcare, food production, energy supply, climate change, and personal safety. The majority of UK pathology services will be UKAS ISO15189 accredited by 2018, including transitional ‘dual’ CPA standards/ ISO15189 accreditation between 2015 and 2018. It also provides ISO22870:2006 accreditation that is point of care specific, as well as ISO17025:2005, which applies to calibration standards.