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

• 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

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

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 / 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

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. 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

Assessment Visit Process

• Examination of paperwork.

• AuditsVerticalHorizontalExamination

• 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.

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

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