CPA (UK) Ltd Assessments Everything you wish you had known before the visit Alison Springall Regional Assessor 5 Februar

1. CPA (UK) Ltd AssessmentsEverything you wish you had known before the visitAlison Springall Regional Assessor5 February 2009

3. CPA (UK) Ltd Assessments • 4 year cycle • 2 year Surveillance visit

4. Number of Cytology Laboratories • Accredited = 93 • Conditional Approval = 56 • Referred = 22

5. Reasons for referral • Refused visit • Conditions not met • Timescales for critical non compliances expired

6. Process for main assessment visit • Regional Assessor will contact lab to arrange dates • Timetable and required documentation sent in advance • Visit with peer assessors • Support during and after the visit • Feedback to CPA on the experience • All laboratories have had a main assessment visit

7. Process for surveillance visit • Regional Assessor will contact laboratories • Surveillance visit will take place within 2 years of main assessment • 1 day assessment • Regional Assessor will be on their own • May be occasions when peer assessor may also attend

8. Surveillance Visit • On going compliance with CPA Standards • Check progress with any outstanding non compliances from main assessment • May be accompanied by peer assessor • Continuing support for laboratories

9. Revised standards • Version 2 (Sept 2007) • In place since September 2007 • Launched at conference April 2008 • Assessed against this standard since April 2008 • Will now affect the status of laboratories

10. Revised standards – main findings A3.1a Quality Policy – scope of the service A6.2 d Quality Manual – roles and responsibilities of laboratory management, including the Quality Manager

11. Revised standards – main findings • A11 Annual Management Review • Annual Registration form includes the template for the executive summary • Includes all the items that should be discussed at the Annual Management Review • Quality Policy and Quality Objectives are reviewed

12. Revised standards – main findings • B1 – Laboratory Director • Duties of Laboratory Director should be documented • Delegated duties and responsibilities documented

13. Revised standards – main findings • B2.2 Registration of staff • Regular checks that staff are registered • Include in the schedule for audit

14. Revised standards – main findings • B5.1f Job descriptions should include that staff participate in appraisal

15. Revised standards – main findings • B9 Training and Education • Training programme for all staff- don’t forget MLA’s and clerical staff • Assessments of competency following training • Records of training and competency assessments • Include any problems and retraining

16. Revised standards – main findings • D1.2 – procedure for procurement and management of equipment • Trust procedure may not cover all the requirements of the standard • Inventory of equipment – include the location of equipment

17. Revised standards – main findings • E1.2 – Information for Users • Ensure that it includes all the requirements of the standard • Produce it in conjunction with the users • Where is it available? • They may not find 177 pages easy to use!

18. Revised standards – main findings • H1.1 Evaluation and Improvement • Ensure that you have procedures for all of the standard

19. Revised standards – main findings • H6 Quality Improvement • Establish Quality Indicators • Examination processes • Non examination processes • Determine methods and frequency of monitoring

20. Revised standards – main findings • H7 – Identification and control of non conformities • Method of recording all non conformities ie. Internal errors and non conformities from audit • Regular review to detect trends • Corrective and preventive actions

21. Revised standards – main findings • Procedure to be implemented in the rare event of wrong results being released • Stop analysis, recall results • Has an harm come to patients • Investigate, corrective & preventive actions • Authority for resuming the analysis

22. Audit Cycle • Plan – audit schedule, define scope of audit • Do – carry out audit • Check – against CPA standard, record findings, root cause, monitor corrective actions • Act – put improvements in place • Start cycle again

23. Quality Improvement • Remedial Action – quick fix • Corrective Action – will eliminate the root cause of non conformities • Preventive Action – will eliminate the causes of potential non conformities • Improvement – continual cycle

24. What QMS audits are required • Evaluation of Quality Policy • Needs and requirements of users • Staff are familiar with QM and all procedures relevant to their work • Good professional practice, training • Health and safety • Environmental • Compliance with CPA standards

25. Needs and requirements of users • Evidence of regular meetings with users • Assessment of User satisfaction • Not only assessed by questionnaire • Record findings as with any other audit • Put improvements in place

26. Staff are familiar with QM and all procedures relevant to their work • Evidence of induction • Vertical audits • Examination audits

27. Good professional practice • Training programme for all staff • Training records • Competency assessments • Evidence of CPD • Registration of staff

28. Health & Safety • Health and Safety audits • Evidence of good housekeeping • Equipment – PAT testing

29. The myth – All office equipment must be tested by a qualified electricianThe reality – The law requires employers to assess risks and take appropriate action

30. Environmental • Waste management audit • Equipment - maintenance

31. Compliance with CPA standards • Horizontal audit against CPA standards • Don’t have to do it all in one audit • Break it down into sections of the standard

32. What makes for a good assessment visit • Clear instructions • The same for every laboratory • Learned something new • An opportunity to comment on the experience

33. Take home messages • Know the CPA “Standards for the Medical Laboratory” • Quality Management is not just a Managers responsibility • Say what you do and do what you say • If it isn’t documented then it hasn’t happened

34. Take home messages • Use and abuse your Regional assessor • Not just for the assessment visit • Consistent approach • Can’t do it for you

35. Useful websites • www.cpa-uk.co.uk • www.hse.gov.uk/myth

36. Thank you