Laboratory Accreditation – An
Assessors Perspective
Dr Jonathan berg
City Hospital, Birmingham
Areas to Consider
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Clinical Pathology Accreditation Ltd
Quality System
CPA Standards
Assessment Process Explained
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
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
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.
• Main office in Sheffield.
• New Regional Organisation now
established.
• Accredits Pathology Departments and
EQA Schemes.
• External audits against a set of standards.
CPA Organisation
CPA (UK)Ltd
BOARD
CENTRAL
OFFICE
CPA / UKAS
Partnership
Council
Professional Advisory
Committee
LABORATORY
ACCREDITATION
United Kingdom
Accreditation Service
(UKAS)
CPA(EQA) Advisory
Committee
EQA SCHEMES
MEDICAL LABORATORIES
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.
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.
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.
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
A. ORGANIZATION AND QUALITY
MANAGEMENT SYSTEM
B. PERSONNEL
C. PREMISES AND ENVIRONMENT
D. EQUIPMENT, INFORMATION
SYSTEMS & MATERIALS
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H. EVALUATION AND QUALITY
ASSURANCE
E. PRE EXAMINATION PROCESS
F. EXAMINATION PROCESS
G. POST EXAMINATION PROCESS
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Assessment Visit Process
• Examination of paperwork.
• Audits
Vertical
Horizontal
Examination
• Meetings with CEO and user group
Quality System
• Described by Quality Manual & includes a
Quality Statement.
• Encompasses all standards.
• Should describe what is actually in place.
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!
Horizontal Audit
• Looks in detail at one aspect:
e.g. Sample reception, Meetings
Assessor Findings
• Critical non-compliance.
• Non-critical non-compliance.
• Observation.
Clinical Pathology
Accreditation (UK) Ltd
VERTICAL AUDIT FORM
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
Information for users
Standard
E 1.1
Is there information readily available to users
relating to specimen requirements for th ese tests?
Check:- User handbook
.
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
E4
Records/methods
checked and
procedures
witnessed
Findings
Corrective and/or
preventive action
Action completed
Signed/dated
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