Delia Geary
Specialist Support Assessment Manager,
United Kingdom Accreditation
Service (UKAS)
The United Kingdom Accreditation Service (UKAS) is the sole national accreditation body recognised by the Government to assess, against internationally agreed standards, organisations that provide certification, testing, inspection and calibration services.
Accreditation by UKAS means that evaluators – that is, the testing and calibration laboratories, certification and inspection bodies – have been assessed against internationally recognised standards to demonstrate their competence, impartiality and performance capability
UKAS is a non-profit-distributing private company, limited by guarantee. UKAS is independent of Government but is appointed as the national accreditation body by the Accreditation Regulations 2009 (SI No 3155/2009) and operates under a Memorandum of Understanding with the Government through the Secretary of State for Business, Innovation and Skills
Origins of point-of-care testing (POCT)
The concept of POCT has its origins in the 15th–17th centuries with urine testing, and ranging from adding a few drops of oil to calculate a patient’s life span to determining the sweetness of urine by tasting. Technology has fortunately progressed greatly since these early days and POCT is rapidly becoming a unique discipline within pathology.
Standards
Public awareness of the availability of POCT has been increasing with greater access than ever before to community based testing. The introduction of ISO 22870:2006 (Point of Care Testing – particular requirements for quality and competence), applied in conjunction with ISO 15189:2007 (Medical Laboratories – particular requirements for quality and competence), means there are now international standards that can be used in the accreditation of organisations that provide POCT. However, there are some limitations in the application of these standards; for example, it is not intended that home-based self-testing could be accredited to these standards at present.
Accreditation is an important element in establishing and maintaining confidence in a POCT provider. In the report by Lord Carter of Coles on the review of NHS pathology services in England in 2006,(1) accreditation of POCT providers was a key recommendation.
Accreditation to ISO 15189 with ISO 22870 provides confidence in the competence of organisations delivering point of care testing services. Essential aspects of the assessment against the requirements of these standards include establishing where the responsibility for the testing rests and determining that the operators are competent to carry out the tests concerned. ISO 22870 also places emphasis on the need for POCT providers to be involved in clinical governance and this is also addressed during assessments.
Following the acquisition of Clinical Pathology Accreditation (CPA) by UKAS, accreditation to ISO 15189 with ISO 22870 for POCT can be achieved through a joint assessment by UKAS and CPA, where CPA provides the specialist technical input and knowledge of the sector.
Scope
POCT is now ubiquitous in healthcare environments and involves all stages of healthcare from the commencement of emergency care (for example, with paramedics) to intensive care units. In the community, many General Practitioners operating in primary care use some form of POCT. Accreditation of POCT providers, whether the testing is provided through a typical medical laboratory or through an independent provider, presents many challenges, particularly in the non-conventional ‘hub and spoke’ models that have become established in the private sector and are now being seen more frequently in the public sector (Figure 1).
The challenges of the Hub and Spoke model
The hub is generally the main head office from which the management system is coordinated and which could also include the main medical laboratory. The accreditation process includes identification and assessment of the entity that takes legal responsibility for the results, and accreditation is granted to only one legal entity under a single accreditation reference number.
The ‘spokes’ or POCT delivery points in this model can be hospital wards, clinics or surgeries and which might not be under the direct line management of the POCT service provider. Point of care testing at these sites therefore has to be demonstrably under the control and responsibility of the accredited provider with respect to the provision of the point of care testing service. This could be demonstrated through a contractual arrangement between the accredited entity and the legal entity where the delivery point is based. The detail within the contract or ‘agreement’ is an essential element to the accreditation process and is therefore subject to rigorous assessment.
The assessment process will distinguish between those POCT services that offer the management of POCT rather than the provision of the testing service. This is an important issue as potentially there are significant differences between the two with regards to responsibility for the results.
Competence
Establishing and maintaining competence of the operators working in the individual delivery points or ‘spokes’ and the pivotal role of the body coordinating POCT are key elements of the assessment process. Clear procedures must be in place and implemented to ensure that only authorised, competent operators who can demonstrate continued competence undertake testing.
Satisfactory performance in appropriate EQA (external quality assurance) and internal quality control programmes are important mechanisms for demonstrating maintained competence. There must be evidence to show that performance (and participation) is regularly reviewed (by the hub) with any anomalies in performance investigated and the potential impact on patients’ results evaluated.
The underlying importance of establishing the reliability and accuracy of the results and their comparability to conventional laboratory-generated results underpins the clinical governance of the POCT and the assessment process will address this.
Management system
An effective management system that underpins the coordination and management of the overall POCT service across all delivery points is a key component to the successful provision of the service. To comply with ISO 15189/22870 overall control of the management system must be under the responsibility of a Quality Manager who has appropriate competence, authority and resources. Part of the responsibilities of the Quality Manager must be effective planning of the audit programme.
Audits are an essential tool for demonstrating on-going conformity with both internal procedures and ISO 15189/22870 and can also be used in a proactive manner to identify preventive actions (that is, to prevent the occurrence of non-conformities) and potential improvements. Inclusion of the spokes in the audit programme, with auditing of testing activities being a component of the programme, is an important factor in demonstrating control by the hub of the activities undertaken at the delivery points (spokes).
Information technology (IT)
The generation of results following POCT and subsequent review for possible urgent communication to clinical staff is a critical element to the service. Effective interfacing of IT systems to the hub for appropriate commentary by clinicians with the appropriate background and also to the clinicians responsible for the care of the patient is essential for POCT to be useful as a tool in managing patient care. As the delivery points can be at different sites with potentially different IT arrangements, the impact of the various systems has to be established and the impact on the service considered.
Conclusions
Accreditation to ISO 15189 with 22870 gives confidence in the quality of the testing service offered at point-of-care. The accreditation process includes an assessment of the overall competence of the entity seeking accreditation through an evaluation of the effectiveness of the management system and the mechanisms implemented to establish and maintain competence of all relevant personnel. The organisation of the POCT and identification of associated responsibilities are essential in establishing confidence in the results and the overall service delivery.
Key control points such as audits, EQA and internal quality control measures across all POCT services and delivery points offered by a particular organisation are intrinsic to the assessment for accreditation to ISO 15189/22870
Further information on UKAS
and accreditation can be found at
www.ukas.com.
References
- Department of Health. Report of the review of NHS pathology services in England. Department of Health 2006. www.dh.gov.uk.
