1. POCT In Canada and at ISO/TC 212 Sheila Woodcock QSE Consulting Convener ISO/TC212 WG1: Quality & competence in the medical laboratory

2. POCT in Canada Widespread use in hospitals Most common tests: glucose, urinalysis, blood gases Some small hospitals have replaced traditional labs with POCT equipment operated by nurses and supervised by lab staff located off site. Glucometers and blood gas machines are often connected to a network, QC monitored by the lab and non-conforming instruments can be locked out

3. POCT accreditation Laboratory accreditation is mandatory in most Canadian provinces. Accreditation has included POCT since 2003 Standards used are ISO15189, ISO22870 and ISO15190 for safety 4 year cycle Physicians performing testing in their own offices or clinics for their own patients are exempt from accreditation

4. Challenges Hospitals sometimes fail to clearly define roles and responsibilities for POCT Tests such as occult blood and beta HCG may be overlooked by the hospital and not included in POCT All requirements of ISO 22870 must be met for all POCT performed in hospitals and reported in the health records Proficiency testing may not be available for all POCT

5. Institute for Quality Management in Healthcare (IQMH) Leader in accreditation in Canada Based in Ontario 232 labs accredited both in Canada and other countries (Trinidad and Senegal) Signatory to the MRA of APLAC and ILAC Compliant with ISO/IEC 17011 Assessor training program with mandatory periodic updates

6. ISO/TC212 Clinical laboratory testing and in-vitro diagnostic test systems 5 Working Groups – WG1 Quality and competence in the medical laboratory – WG2 Reference systems – WG3 In-vitro diagnostic products – WG 4 Microbiology and molecular methods – WG5 Laboratory Biorisk Management

7. ISO/TC212 WG1 ISO 15189:2012 Medical Laboratories – Requirements for quality and competence ISO 22870:2006 Point-of-care-testing – Requirements for quality and competence ISO 15190:2003 Medical Laboratories – Requirements for safety ISO 22367:2008 Medical laboratories - Reduction of error through risk management and continual improvement ISOTS20658 Medical laboratories— Requirements for collection, transport, receipt and handling of samples

8. Future of POCT and standards POCT will continue to grow and expand POCT benefits doctors and patients ISO POCT Guidance document for POCT outside of hospitals in development Do we need a conformity assessment document for POCT outside of hospitals?

9. Questions?