1. Workshop on implementing internal audit - NGRL (Manchester), St Mary’s Hospital, Manchester October 2003 Audit – a laboratory perspective Simon Patton National Genetics Reference Laboratory (Manchester)

2. Workshop on implementing internal audit - NGRL (Manchester), St Mary’s Hospital, Manchester October 2003 Reference lab DoH funding - National Genetics Reference Laboratory status in 2002DoH funding - National Genetics Reference Laboratory status in 2002 Part of our NGRL remit = quality systems for genetic testingPart of our NGRL remit = quality systems for genetic testing –EQA –Reference materials –Accreditation to provide assistance to genetics laboratories in implementing new CPA accreditation standardsto provide assistance to genetics laboratories in implementing new CPA accreditation standards Info can be found on the NGRL websiteInfo can be found on the NGRL website –www.ngrl.org.uk “How can we help you?”“How can we help you?” –Workshop on implementing audit

3. Workshop on implementing internal audit - NGRL (Manchester), St Mary’s Hospital, Manchester October 2003 About Us NGRL (Manchester)NGRL (Manchester) –Molecular Genetics –Cytogenetics –Clinical Genetics Molecular GeneticsMolecular Genetics –36 staff –3500 samples a year –Last accredited May 2002 –Next inspection due Spring 2005 CytogeneticsCytogenetics

4. Workshop on implementing internal audit - NGRL (Manchester), St Mary’s Hospital, Manchester October 2003 Meeting the challenges of the new standards Quality manager in postQuality manager in post –½ time position –shared between DNA and Cyto Document controlDocument control –All documents (260+) on e.document archive since 2001 –Moved over to Q-Pulse in 2003 –Reviewed at least annually

5. Workshop on implementing internal audit - NGRL (Manchester), St Mary’s Hospital, Manchester October 2003 Meeting the challenges of the new standards Q-PulseQ-Pulse –Up and running for Document control –Currently setting up for: AuditsAudits Monitoring non-conformancesMonitoring non-conformances Recording corrective actionsRecording corrective actions Equipment maintenance/inventoryEquipment maintenance/inventory Training registerTraining register

6. Workshop on implementing internal audit - NGRL (Manchester), St Mary’s Hospital, Manchester October 2003 Our approach to audit Decided to trial vertical audit firstDecided to trial vertical audit first –We felt it was the easiest to implement first Use vertical audit to flag up areas that need further investigation using:Use vertical audit to flag up areas that need further investigation using: –Horizontal audit –Witness / examination audit

7. Workshop on implementing internal audit - NGRL (Manchester), St Mary’s Hospital, Manchester October 2003 Progress!? Done 5 vertical auditsDone 5 vertical audits –3 using a slightly modified version of CPA form Decided to do these full vertical audits every 3 rd auditDecided to do these full vertical audits every 3 rd audit –2 using a mini-vertical audit – concentrates on the laboratory pre-examination, examination and post- examination processes These are done following a full vertical auditThese are done following a full vertical audit

8. Workshop on implementing internal audit - NGRL (Manchester), St Mary’s Hospital, Manchester October 2003 Progress!? No horizontal or examination audits have been done yet!No horizontal or examination audits have been done yet! –Vertical audits have identified several areas which we will be targeting shortly Most of the paperwork has been doneMost of the paperwork has been done Still to use Q-Pulse to schedule audits and record non-conformanciesStill to use Q-Pulse to schedule audits and record non-conformancies

9. Workshop on implementing internal audit - NGRL (Manchester), St Mary’s Hospital, Manchester October 2003 The auditors… Working group of 6 staff to trial auditsWorking group of 6 staff to trial audits Aim to include all staff in the audit processAim to include all staff in the audit process –Scientists, technicians and clerical staff –“sense of ownership” –Avoid top-down approach –Rotate on an annual basis Identify training course for first years auditors, thenIdentify training course for first years auditors, then –Established auditors to “train” new auditors

10. Workshop on implementing internal audit - NGRL (Manchester), St Mary’s Hospital, Manchester October 2003 Lessons learnt - Pros Already identified weaknesses, problems and non-conformanceAlready identified weaknesses, problems and non-conformance –e.g., equipment maintenance Has lead to improvements in proceduresHas lead to improvements in procedures –e.g., modifications to specimen reception procedures All laboratory staff will hopefully have a better sense of ownership of their workAll laboratory staff will hopefully have a better sense of ownership of their work

11. Workshop on implementing internal audit - NGRL (Manchester), St Mary’s Hospital, Manchester October 2003 Lessons learnt - Cons Slow process to:Slow process to: –implement it –For all staff to understand the benefits of audit Formal training is important:Formal training is important: –Asking the right question –Not to appear judgemental TIME!!TIME!! Need to be careful that it is not seen as another paper wasting exercise!Need to be careful that it is not seen as another paper wasting exercise! Care needed to ensure you don’t just target the things you know / do best.Care needed to ensure you don’t just target the things you know / do best.