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Laboratory Accreditation

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Title: Laboratory Accreditation


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 170252000 General requirements for the
  • competence of testing and calibration
    laboratories
  • ISO 90012000 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

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15
Assessment Visit Process
  • Examination of paperwork.
  • Audits
  • Vertical
  • Horizontal
  • Examination
  • Meetings with CEO and user group

16
Quality System
  • Described by Quality Manual includes a Quality
    Statement.
  • Encompasses all standards.
  • Should describe what is actually in place.

17
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!

18
Horizontal Audit
  • Looks in detail at one aspect
  • e.g. Sample reception, Meetings

19
Assessor Findings
  • Critical non-compliance.
  • Non-critical non-compliance.
  • Observation.

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22
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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