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Laboratory Accreditation: Definition and Importance

Laboratory Accreditation: Definition and Importance. Lampros Mavrogiannis (Newcastle 08/11/2007). Questions asked. Definition of accreditation (clinical laboratory). CPA and the UK accreditation system. Mechanics of accreditation. The standards. Importance of accreditation.

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Laboratory Accreditation: Definition and Importance

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  1. Laboratory Accreditation: Definition and Importance Lampros Mavrogiannis (Newcastle 08/11/2007)

  2. Questions asked Definition of accreditation (clinical laboratory) CPA and the UK accreditation system Mechanics of accreditation The standards Importance of accreditation

  3. Accreditation definition ISO definition formal recognition by authoritative body that person or organisation is competent to perform specific tasks different from ISO certification – assurance that a product or service conforms to certain requirements Application in healthcare recognition of quality, following voluntary or compulsory assessment against standards and demonstration of substantial compliance

  4. Clinical laboratory accreditation in the UK Clinical Pathology Accreditation (UK) Ltd CPA is a distinct body, operationally independent from the national accreditation body, the UK Accreditation Service Owned by pathology stakeholders (shareholders include RCPath and ACS) Self-regulation In principle voluntary participation of laboratories (not a legal requirement as in US), but compulsory de facto – in everyone's interests

  5. Operational framework Components of the system Accreditation authority - CPA Standards - CPA, ISO, other standards Inspectors - senior professionals Laboratories

  6. Accreditation standards Two aspects Quality management standards Technical competence standards The normative documents CPA standards ISO series (ISO 9001:2000, quality; ISO 17025:1999, generic lab quality and competence; ISO 15189:2002, medical lab quality and competence) Other standards

  7. Accreditation standards CPA standards

  8. Importance of accreditation In theory... formal national recognition meeting needs, protecting interests of clinicians and patients improve business exchange and lab networking facilitating management ...and in practice essentially impossible to get/renew NHS contracts (CPA enrolment formally demanded or strongly advised by GenCAG, Joint Genetics Committee, UKGTN, HGC, etc)

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