Review: Policies, procedures and guidelines for point-of-care testing

United Kingdom (UK)

Page last updated: 14 May 2013

Different operational healthcare policies may apply to England, Scotland, Northern Ireland and Wales. The National Health Service (NHS) is the name commonly used to refer to the four single-payer publically funded healthcare systems in the UK (collectively or individually), although only the health service in England uses the name National Health Service without further qualification. In addition, much of the decision making is now made through local trusts, which provide policy and guidance for healthcare providers within their jurisdiction.

The second phase of the review of the National Health Service (NHS) in England chaired by Lord Carter of Coles, defines a clear path for the reorganisation of pathology services. The report states that quality management procedures and an upgraded accreditation system should be mandatory for all pathology service providers, including providers POCT.113 In particular, recommendation 12 states “…that all pathology service providers should be subject to mandatory accreditation by an organisation independent of the providers and the professions. Mandatory accreditation (including of point-of-care testing) gives 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.”114 In addition, recommendation 14 states “… that all providers of pathology services (including providers of point-of-care testing) should be required to participate in clinical audit and other clinical governance activities, as a further means of underpinning quality; and that all staff involved in the delivery of pathology services, including technical and support staff, participate in relevant continuous professional development as part of maintaining their competence.”114 Currently however, many of the NHS health trusts have developed their own policy statements with regard to POCT, but most (if not all) seem to follow a similar template and provide similar information. All include specific reference to quality control and quality assurance which are obligatory procedures for POCT operators. Six examples are provided for information.45,46,47,48,49,50 Trust “policy” statements are essentially mandatory requirements for testing services within their jurisdiction.

The UK Department of Health deals with non-devolved and other matters common to all systems. Various agencies within the Department of Health provide a plethora of guidelines and recommendations. These guidelines are used by local trusts and healthcare providers as recommendations or policy statements. For example, the Medicines and Healthcare Products Regulatory Agency (MHRA)115, previously the Medical Devices Agency (MDA), provides the recently updated (February 2010) guidelines Management and use of IVD point-of-care test devices 44.

In a review of pathology services in Northern Ireland, the Department of Health, Social Services and Public Safety, made specific comment on the proposed management of POCT.116,117 In their final report Recommendations for the future of pathology services in Northern Ireland published in December 2007, the Department agreed “… that POCT should be managed under a regional framework in line with CPA accreditation standards and guidelines of the Royal College of Pathologists [recommendation 14]”.57 In addition, Northern Ireland also uses the Medical Devices Agency (MDA) documents, reissued under the auspices of Health Estates, an executive agency of the Department of Health, Social Services and Public Safety.58

In a similar manner, the Welsh Scientific Advisory Committee (WSAC, which directly advises the Welsh Assembly Government on professional scientific and technological matters related to health issues118), issued a policy guideline The use of diagnostic equipment and procedures outside the diagnostic laboratory, which applies to POCT performed in non-laboratory sites which include “ … secondary care sites: A&E, ITU, SCBU, general ward areas, theatres, diabetic clinics, and outpatient departments.” and “primary care sites to which this circular applies include: GP surgeries, Community Clinics, Health Centres, Anticoagulation Clinics, patients’ homes, and paramedical services including the ambulance service.”56

In addition to policies and guidelines developed by the Department of Health and individual NHS jurisdictions, operational guidelines for specific POCT applications have been developed by professional groups such as the British Committee for Standards in Haematology55, the Association of Clinical Biochemists53 and the Royal College of Pathologists54. Two examples of clinical practice guidelines produced for general practitioners by the British Medical Association (BMA), provide specific instructions for POC drug testing and anti-coagulation monitoring.59,60 Both of these procedures require appropriate quality control and quality assurance. An outline of two approaches to the issues of accreditation and POCT are provided by Burnett119 and Thomas120.