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Laboratory Accreditation – An Assessors Perspective

Laboratory Accreditation – An Assessors Perspective. Dr Jonathan berg City Hospital, Birmingham. Areas to Consider. Clinical Pathology Accreditation Ltd Quality System CPA Standards Assessment Process Explained. Accreditation Basics.

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Laboratory Accreditation – An Assessors Perspective

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  1. Laboratory Accreditation – An Assessors Perspective Dr Jonathan berg City Hospital, Birmingham

  2. Areas to Consider • Clinical Pathology Accreditation Ltd • Quality System • CPA Standards • Assessment Process Explained

  3. Accreditation Basics • System to show a healthcare facility has reached standard required to carry out prescribed function. Three Elements: 1. Assessment Board 2. Set of Standards 3. Assessment Process – assessors and system of registration and inspection

  4. Standards for Laboratories The new international standards ISO 15189 Quality management in the medical laboratory ISO 17025:2000 General requirements for the competence of testing and calibration laboratories ISO 9001:2000 series Quality management systems - requirements

  5. CPA Ltd • Set up by UK professional bodies 1991: RCPath, ACB, ACP, IBMS etc. • CPA and United Kingdom Accreditation Service (UKAS) formed a partnership in 2002. • NHS Laboratories must be registered for accreditation.

  6. Main office in Sheffield. • New Regional Organisation now established. • Accredits Pathology Departments and EQA Schemes. • External audits against a set of standards.

  7. CPA Organisation

  8. CPA Assessment Procedure • Assessors: Mixture of paid and peer “professional” assessors. • New Standards – 2003. • New Processes: Implemented in 2005/06. • Assessment Process: Centres on sampling of the quality system audits.

  9. Assessors • Old Style: All laboratory staff – Consultant & BMS - pair per discipline. • New Style: CPA Employee assessors and input from laboratory peer review. • Why Change?: peer reviewers scarce, lack of consistency, more professional.

  10. CPA Accreditation Means…… • Full inspection every 4 years. • Interim inspection every 2 years. • Updated registration form every year with annual management review. • Significant changes in service should be notified to CPA office when they occur.

  11. The CPA Standards A. Organisation and Quality Management System B. Personnel C. Premises and Environment D. Equipment, Information Systems and Materials E. Pre-Examination Process F. Examination Process G. Post Examination Process H. Evaluation and Quality Assurance

  12. Assessment Visit Process • Examination of paperwork. • Audits • Vertical • Horizontal • Examination • Meetings with CEO and user group

  13. Quality System • Described by Quality Manual & includes a Quality Statement. • Encompasses all standards. • Should describe what is actually in place.

  14. Vertical Audit • Follows a sample through laboratory. • Pre-analytical, analytical and post analytical phases. • When problems are found then in-depth investigation. • Takes about 3 hours. • You should all have one on your lab wall!

  15. Horizontal Audit • Looks in detail at one aspect: e.g. Sample reception, Meetings

  16. Assessor Findings • Critical non-compliance. • Non-critical non-compliance. • Observation.

  17. Non Compliance Sheet • Findings written down by assessor. • Discussed and agreed at closing meeting • Assessor sends to CPA Office: • Non-compliance forms • Overview report • Report on meeting with users • Meeting with Chief Executive

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