Lessons from CPA Laboratory Accreditation

Executive Summary Accreditation by Clinical Pathology Accreditation (UK) Ltd • Voluntary, but expected norm • Professionally driven • Coveted reward

Different perspectives

• Laboratory consultant & manager • Peer Assessor for CPA • Assessment decision maker – Professional Advisory Committee of CPA

Pre-CPA 1980s context • Professional standards – unwritten, dispersed, incomplete • Focussed on outcomes – is the result correct • Awareness of health and safety

CPA Accreditation Standards • 1992 formulated own standards – No available medical lab standard – Dialogue medical and scientific bodies – Support from NHS management, DoH • 2003 adopted ISO 15189 (2003) as basis, re-wrote standards – Professions’ guidance on interpretation

Accreditation Process • Voluntary; apply for CPA accreditation • Prepare for visit – Read standards: demonstrate conformity • Assessors visit – CPA staff; medical and scientific peers • Decision on accreditation • Repeat cycle at intervals

CPA outcome generalisations • 5% labs no issues • 5% major issues • 90% in between – Most manage to remedy situation – But some cannot – And some don’t get round to it

Benefits of CPA Accreditation 1 Outside affirmation of good practice • Internationally agreed standards • Interpreted by national professional bodies • Assessed by peers

Benefits of CPA Accreditation 2 Rising expectations • Over the years the same standard • Tend to interpret to a higher expectation • Contributes to continuous improvement

Benefits of CPA Accreditation 3 Mutual learning and sharing of good practice • Dialogue informally during assessment – Assessment visits are not consultancy • Annual training sessions

Benefits of CPA Accreditation 4 Inter-professional respect & friendships • Aids multi-professional working in home lab

Benefits of CPA Accreditation 5 Leverage for change • Evidence to support development – Contributes to but does not replace a proper business case • CPA seeks to remain neutral

CPA & ISO 15189 (2003) • Quality Management System introduced – New concept for hospitals • Appointment of quality managers – Essential – Lab, hospital, industry background – Hours to fit size of task – Can be shared between institutions

QMS overview • Set out ideals for perfect functioning – Guided by ISO standard • Get on with the tests, but acknowledge that all will not be perfect • Audit what’s happening to find non conformity • Put it right, and keep looking • Monitor suitability of QMS

QMS in NHS labs • Would probably not have happened without CPA • Brilliant idea • Continuous improvement • No one would scrap their lab QMS

CPA Lab Visits: ISO 15189 • Continuous preparation, but still a final push • Non-disruptive: work has to go on • Exhausting and emotionally draining for some key staff

Other regulatory bodies MHRA, HFEA, HTA • Fitting together, avoiding gaps • Managing potential CPA encroachment into a regulated activity – Still plenty to learn – Keeping assessors to the task • Coping with (reducing) multiple assessments

Degrees of non-conformity • What did you see on the day of visit?

• Risk assessed: proportionate • Is the issue stuck or on an upward trajectory?

• What confidence do you have in the process / people involved?

SUMMARY Benefits of CPA Accreditation • Outside affirmation of good practice • Rising expectations • Mutual learning and sharing of good practice • Inter-professional respect & friendships • Leverage for change