Laboratory Accreditation – An Assessors Perspective Dr Jonathan berg City Hospital, Birmingham.
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Transcript of Laboratory Accreditation – An Assessors Perspective Dr Jonathan berg City Hospital, Birmingham.
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Laboratory Accreditation – An Assessors Perspective
Dr Jonathan berg
City Hospital, Birmingham
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Areas to Consider
• Clinical Pathology Accreditation Ltd
• Quality System
• CPA Standards
• Assessment Process Explained
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Accreditation Basics
• System to show a healthcare facility has reached standard required to carry out prescribed function.
Three Elements:1. Assessment Board2. Set of Standards3. Assessment Process – assessors and
system of registration and inspection
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Standards for Laboratories
The new international standardsISO 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
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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.
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• Main office in Sheffield.
• New Regional Organisation now established.
• Accredits Pathology Departments and EQA Schemes.
• External audits against a set of standards.
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CPA Organisation
CPA / UKASPartnership
Council
United K ingdomAccreditation Service
(UKAS)
P ro fe s s io nal A d vis o ryC o m m itte e
LAB O RAT O RYAC C RED IT AT IO N
CPA (UK)LtdBOARD
C P A (E Q A ) A d vis o ryC o m m itte e
C E N TR A LOFFIC E
EQA SCHEM ES
M EDICAL LABORATORIES
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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.
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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.
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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.
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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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A. ORGANIZA TION AND QUALITY M ANA GEM ENT S YSTEM
B . PE RSONNELC. P REM ISE S A ND ENV IRONM ENT
D. EQUIP M E NT, INFORM ATION SYS TEM S & M ATE RIA LS
H. EVA LUATION A ND QUA LITY A SS URA NCE
E. PRE EXAM INATION PROCE SS
G. POST E XAM INA TION P ROCES S
F. EXA M INATION P ROCES SUSER
REQUIREMENTS
SATISFACTION
USER
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Assessment Visit Process
• Examination of paperwork.
• AuditsVerticalHorizontalExamination
• Meetings with CEO and user group
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Quality System
• Described by Quality Manual & includes a Quality Statement.
• Encompasses all standards.
• Should describe what is actually in place.
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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!
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Horizontal Audit
• Looks in detail at one aspect:
e.g. Sample reception, Meetings
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Assessor Findings
• Critical non-compliance.
• Non-critical non-compliance.
• Observation.
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CPA Reference code XXXX Procedure observed
Report number XXXX-VARxxx Name of person observed
Department Title Name of assessor
Section Date and signature
Instructions 1. Select a laboratory accession number either from the computer record or from work sheets/day book etc.
2. Trace back the process of specimen handling from receipt to report
Audit area Standard Records/methods
checked and procedures witnessed
Findings Corrective and/or preventive action
Action completed
Signed/dated
Information for users
Is there information readily available to users relating to specimen requirements for th ese tests?
Check:- User handbook
.
E 1.1
Specimen transportation
Are there procedures for specimen transport?
Is there evidence of procedures meeting all Health and Safety requirements?
Check:-
Model rules for couriers, porters and general publi c
.
Packaging , labelling and dispatch procedures
Procedures in the event of spillage
Incident reporting procedure
s
E 4
Clinical Pathology Accreditation (UK) Ltd VERTICAL AUDIT FORM
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Non Compliance Sheet
• Findings written down by assessor.
• Discussed and agreed at closing meeting
• Assessor sends to CPA Office:Non-compliance formsOverview reportReport on meeting with usersMeeting with Chief Executive
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