As noted previously, many countries have developed their own “standards” for laboratory practice and POCT. Most have been developed by expert professional committees in association with the relevant professional colleges and associations. Adherence to these “standards” is often a requirement for government funding, but compliance is also related to the desire for quality testing and good patient care. The threat of litigation for poor quality testing may also be an incentive to comply with a local standard or professional guideline. This may well be an added incentive in the United States of America (US) for adherence to a professionally established protocol. This warning is clearly stated by Mr JR Bierig, a US malpractice lawyer presenting an opinion to the public enquiry by the US Food and Drug Administration (FDA) into the performance of blood glucose meters (see additional comments with regard to this enquiry below; US Food and Drug Administration enquiry into glucose meter performance).29
Mr Bierig stated:30
- “The best way to limit exposure “ … “is to conduct QC in accordance with the manufacturer’s instructions – or, in the absence of such instructions , on a daily basis. In making this recommendation, I recognise that glucose testing is a waived test under CLIA. Thus, federal law does not mandate QC on glucose meters. However, both the Joint Commission and the College of American Pathologists, as part of their respective accreditation programs, require QC in this area.”
“If a hospital or practitioner were sued in this context, the Joint Commission and CAP standards are likely to be put into evidence. Likewise, the package insert will almost certainly be introduced. And there will be testimony on the importance of QC. Thus, despite the waived status of this test under CLIA, malpractice considerations council strongly in favour of performing appropriate QC.”
Individual countries have their own standard(s) development agencies. Some are classed as “standards”, while others are described as “guidelines”. Whatever the terminology, the perceived status of the document(s) or the level of compliance, there is generally a high degree of acceptance by the respective national professional colleges and associations. In many cases, guidelines for POCT have been compiled jointly by pathologists, clinical biochemists, general medical practitioners and nurses.
Table 1 provides a summary of selected national and international quality management procedures for POCT; including the requirement for operator training, proof of competency, quality control and external quality assessment. Most jurisdictions provide statements regarding POCT which include mandatory quality procedures as defined by regulation or specific policy.
Some specific examples of country based “policy”, “standards” and “guidelines” are:
1. Canada
- Ministry of Health and Long-Term Care, Ontario, Canada. Point-of-care testing policy and guidelines for hospitals with a licensed laboratory.31
- Ontario Medical Association. Guidelines: Quality assurance program for INR testing with point-of-care devices in Ontario.32
- Ministry of Health and Long-Term Care, Ontario, Canada. Policies, procedures and quality assurance for point-of-care HIV testing in Ontario.33
- Cancer care Ontario, program in evidence-based care. Guaiac fecal occult blood testing laboratory standards.34
- College of Physicians and Surgeons of Alberta (Canada). Unaccredited point- of-care testing guidelines for physicians.35
- Quebec, Canada. Agence d’evaluation des technologies et des modes d’intervention en santé (AETMIS). Point-of-care testing in the private sector (recommended for government policy and regulation).36, 37
2. France
- Point-of-care testing management protocol using ISO 22870 guidelines and French requirements (to be mandatory by 2016).38
3. Germany (Federal Republic of Germany)
- Directive: the Federal Medical Council for quality assurance of medical laboratory tests (mandatory).39
4. Ireland (Republic of Ireland)
- Joint committee for POCT in primary care and community care. Guidelines for safe and effective management and use of POCT in primary and community care.40
- Joint committee for POCT. Guidelines for safe and effective management and use of POCT.41
5. Spain
- Soto AB etal. Proposed guidelines for point-of-care testing in Spain.42
- Spanish Society of Clinical Biochemistry and Molecular Pathology (SEQC). Guía para la implantación de pruebas de laboratorio en el lugar de asistencia al paciente, 2006.43
6. United Kingdom
- Department of Health (UK). Medical and healthcare products regulatory agency (MHRA). Management and use of IVD point-of-care test devices.44
- NHS Fife. Point-of-care devices.45
- Northern Health and Social Care Trust. Point-of-care testing policy, 2009.46
- Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust. Point-of-care policy, 2008.47
- Ashford and St Peter’s Hospitals Trust. Point-of-care testing policy, 2010.48
- Craigavon Area Hospital Group Trust. Point-of-care testing (POCT) policy, 2008.49
- Conway and Denbighshire NHS Trust. Near patient testing / point-of-care testing policy, 2005.50
- Clinical pathology accreditation (UK). Additional standards for point-of-care testing (POCT) facilities (mandatory if applying for accreditation).51
- NHS. Point-of-care testing in critical care.52
- Association of Clinical Biochemists. Guidelines for implementation of near patient testing, 1993.53
- Royal College of Pathologists (RCPath). Guidelines for point-of-care testing.54
- British Committee for Standards in Haematology. Guidelines for point-of-care testing: Haematology.55
- Welsh Scientific Advisory Committee. Point-of-care testing: The use of diagnostic equipment and procedures outside the diagnostic laboratory.56
- Northern Ireland. Department of Health, Social Services and Public Safety. Recommendations for the future of pathology services in Northern Ireland, 2007.57
- Northern Ireland. Health Estates policy, based on UK Medical Devices Agency (MDA), Management and use of IVD point of care test devices, 2002.58
- British Medical Association. Near-patient testing. National Enhanced Service - provision of near-patient testing (updated December 2003).59
- British Medical Association. Anti-coagulation monitoring. National enhanced Service - anti-coagulation monitoring (revised November 2003).60
7. United States of America
- The National Academy of Clinical Biochemistry (NACB). Evidence based practice guidelines for point-of-care testing.61
- CLSI. Guidelines as indicated in appendix 5.
- Centers for Disease Control and Prevention (CDC). Good laboratory practices for waived testing sites.62
- American Academy of Family Physicians. Office laboratory medicine.63
- College of American Pathologists. Commission on laboratory accreditation.
- Point-of-care-testing checklist (mandatory if applying for accreditation).64
- The Joint Commission. Standards for laboratory accreditation.65