Delia Geary provides a United Kingdom Accreditation Service perspective and insight into the importance of accreditation for point-of-care testing to ensure quality control.
Point-of-care testing is now ubiquitous in all healthcare environments and at every stage, from the commencement of emergency care with paramedics to specialist treatment in acute and critical care units. In the wider community, many GPS offer some form of POC testing via their clinics or surgeries. Accreditation of POC testing providers, whether publicly or privately owned, presents a wide range of challenges, particularly for multisite organisations operating the hub and spoke model.
Accreditation of point-of-care testing services
The introduction of ISO 22870:2006 (Point of Care Testing – particular requirements for quality and competence), applied in conjunction with ISO 15189:2012 (Medical Laboratories – particular requirements for quality and competence), provides a platform for using international standards in the accreditation of organisations that provide POC testing. ISO 22870:2006 is directly applicable to POC testing conducted in hospitals and ambulatory care. While patient-self testing in the home (or a community setting) is excluded from the standard, elements of ISO 22870:2006 can still be applied. However, as ISO 22870 is not a standalone standard, it needs to be used in conjunction with ISO 15189. This means that the POC testing provider must also be accredited to ISO 15189.
Since the transition to ISO 15189:2012 commenced in October 2013, UKAS has been talking on a case by case basis to organisations accredited to CPA standards for POC testing about the process of transitioning to ISO 22870 when their next ISO 15189 assessment became due. Any new applicants for POC testing accreditation may only apply for ISO 15189/ISO 22870 accreditation.
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