Uploaded byNikos Papachristou
Working Group On Poct
The document discusses a working group report on point-of-care testing (POCT) involving multiple countries, focusing on the implementation of ISO standard 22870:2006. It highlights challenges such as lack of regulations and the need for common policies and quality requirements for POCT instruments. Additionally, it mentions ongoing efforts to assess and certify POCT instruments to ensure quality and usability in healthcare settings.
Working Group On Poct
- 1. Working group onPOCT Report
- 2. Working group Iceland Italy Norway Spain Sweden Annette Artelt EPBS
- 3. Questionnaire from Italy Sent in 2007 Evaluated the answers from from: Iceland The Netherlands Sweden Norway Spain
- 4. Questionnaire What kindof information is necessary in order to move forward on this subject? Detailed questionnaire – challenges Lack of regulations Diversity within countries
- 5. Questions sent tomembers before this meeting Policy regarding POCT Implementation of ISO standard 22870:2006 Certification of POCT instruments
- 6. Policies received IBMSUnited Kingdom AMLS Ireland LabMed Switzerland Australia Sweden Norway
- 7. ISO 22870:2006 Point-of-caretesting (POCT) -- Requirements for quality and competence ISO 22870:2006 gives specific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO 15189. The requirements of ISO 22870:2006 apply when POCT is carried out in hospital, clinic and by a healthcare organization providing ambulatory care. Patient self-testing in a home or community setting is excluded, but elements of ISO 22870:2006 can be applicable.
- 8. Implementation of ISO22870 Work just starting in most countries
- 9. Certification of POCTinstruments IVD Directive HMS regulations Description of the instrument No regulation of the sensitivity and specificity of the Analyte
- 10. Certification of POCTinstruments UK: Guidance Notes from the Medicines and Healthcare products Regulatory Agency The Dutch Healthcare Directorate
- 11. Certification of POCTinstruments Scandinavia: The Scandinavian evaluation of laboratory equipment for primary health care (SKUP) SKUP gathers information about laboratory instruments intended for use in primary care, as well as organising assessment of such instruments The goal of SKUP is to produce objective and independent information concerning the quality and user-friendliness of laboratory equipment for physicians' offices outside the hospital
- 12. Continuing work Focuson the quality and the performance of the tests What kind of tests should be used Requirements for quality of instruments Requirements of competence Questionnaire?
- 13. Common policy Questionfrom IFBLS: Common policy for IFBLS and EPBS?