1. CPA is a UKAS company The Assessment Visit UKAS Processes John Ringrow – Senior Assessment Manager

2. CPA is a UKAS company The Assessment Process Application information Resource requirements Preparation for the assessment The assessment A Quality Pathology Service?? © UKAS November 2014

3. CPA is a UKAS company Accreditation ISO/IEC 17000: 2004 Third-party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks © UKAS November 2014

4. CPA is a UKAS company In simple terms….. Providing confidence that a body can provide reliable, reproducible outcomes that are fit for purpose…….. Expectation that one will get the ‘right’ result and a reliable outcome © UKAS November 2014

5. CPA is a UKAS company Purpose of Assessment Can you demonstrate your competence? Has competence been maintained since the last assessment –Records, minutes, feedback, complaints Are you still competent now? –Witnessing, interviewing, questioning How will you maintain competence in the future? –Effective & compliant Quality Management System © UKAS November 2014

6. CPA is a UKAS company Application Information UKAS Application Form AC6 Form UKAS Agreement and supplement © UKAS November 2014

7. CPA is a UKAS company AC 4 Form Scope of activity – repertoire, equipment and location © UKAS November 2014

8. CPA is a UKAS company AC 6 Form Scope of activity – repertoire, equipment and location © UKAS November 2014

9. CPA is a UKAS company AC 6 Form Identification of other activities that support the functioning of the laboratory and where these activities are conducted e.g. facilities management, HR, Procurement etc. Identification of activities outside of the scope of ISO 15189 Details of in-house calibration activities Details of locations © UKAS November 2014

10. CPA is a UKAS company Schedule of Accreditation © UKAS November 2014

11. CPA is a UKAS company Assessment Team Application review will determine team and duration Assessment Manager plus Technical Expert – some could be involved remotely, before or after on-site assessment – all trained in ISO 15189 UKAS Observer – to monitor and review © UKAS November 2014

12. CPA is a UKAS company Assessment Preparation Provision of additional information from the lab is likely –Gap analysis – specific issues –System documentation and procedures UKAS will provide a visit plan –Timetable for the assessment –Indicate what activities will be assessed and ‘witnessed’ © UKAS November 2014

13. CPA is a UKAS company Assessment Report UKAS reporting and assessment procedures are given in Lab 3 and Gen 3 (www.ukas.com) Main report prepared by Lead Assessor with input from all of the team Currently the report is structured around the following headings: Scope, Organisation, Management, Evaluation Processes, Technical Competence and Impartiality & Integrity Format may be modified © UKAS November 2014

14. CPA is a UKAS company Next Steps Usual UKAS process: Recommendation Timescales for clearing findings Mechanism for clearing findings © UKAS November 2014

15. CPA is a UKAS company What to expect… Scoping and hence coverage of the scope at the assessment Increased planning and up front preparation Different ‘routine’ in the assessment but plan will provide details Impact of the different requirements e.g. decreased focus on H&S Evidence based approach © UKAS November 2014

16. CPA is a UKAS company What to expect….. Focussed discussions on key differences such as traceability, validation etc. To demonstrate how you meet the requirements The assessment will focus on outcomes Assessment will seek to demonstrate that accreditation can be granted……remember what accreditation is expected to deliver © UKAS November 2014

17. CPA is a UKAS company Pathology End to End Processes © UKAS November 2014

18. CPA is a UKAS company © UKAS November 2014

19. CPA is a UKAS company A Quality Service? The right result on the right specimen from the right patient that is accurate, timely, and properly interpreted Reliability Robustness Responsiveness © UKAS November 2014

20. CPA is a UKAS company A Quality Service? Evidence that pathology services are reliable: given the right question, they will provide the right answer. –EQA –IQA –IQC © UKAS November 2014

21. CPA is a UKAS company A Quality Service? They are robust, because they are continually improving their processes in the light of experience –Internal Quality Audit –Clinical audit –Error / incident logging and management © UKAS November 2014

22. CPA is a UKAS company A Quality Service? They are responsive: they are capable of adjusting to the varied needs of patients and clinical users of all kinds –User feedback –User surveys © UKAS November 2014

23. CPA is a UKAS company A Quality Service? Accreditation is a binary measure You are either accredited or you are not Useful for Commissioners and patients but does not articulate what factors predict failure CPA / ISO 15189 are minimum acceptable standards, not aspirational standards They cannot differentiate the satisfactory from the best laboratories Accreditation plus College KPIs? Need relevant quality indicators Identifying good markers of success We need to articulate what factors predict failure © UKAS November 2014

24. CPA is a UKAS company A Quality Service? Getting things done takes precedence over safety Poor follow up of reported incidents Little effort to maintain knowledge and competence Low level of incident reporting Lack of openness Fear of challenging unsafe work methods Lack of staff empowerment to make improvements Not a blame free climate © UKAS November 2014

25. CPA is a UKAS company A Quality Service? Accreditation (plus) Good EQA performance (Reliable) Good audit performance (Robust) Good incident reporting (Robust) High level of incident reporting Small number of serious incidents reported Good interaction with users (Responsive) Well trained, competent staff Openness (Blame free culture) High Safety Culture Index (just ask the staff) All evidenced by KPIs appropriately reported © UKAS November 2014

26. CPA is a UKAS company Quality Manager/Quality Lead –Integral role –Establishment, implementation, maintenance –Report and interface at ALL levels –Awareness of what pathology does –Fulfil users needs –Support from all staff –Support and recognition by top management © UKAS November 2014

27. CPA is a UKAS company Successful completion of the pilot assessments (Sept 2013) Assessment of the laboratories involved in the first wave of ISO 15189 assessments (Oct 2013 onwards) Identification of the laboratories involved in the second and third wave of assessments (Oct 2013) Website integration (Apr 2014) Previous Key Milestones 15189 Transition Project © UKAS November 2014

28. CPA is a UKAS company Further information © UKAS November 2014

29. CPA is a UKAS company Further information © UKAS November 2014

30. CPA is a UKAS company EA evaluation (March 2014) First grants of accreditation (September 2014) First surveillance visits (Early 2015) Withdrawal of CPA accreditation and standards (anticipated March 2018) Key Milestones © UKAS November 2014

31. CPA is a UKAS company What do labs really need to do? Read ISO 15189:2012 Review Quality Manual and all associated documentation Perform gap analysis Address gaps Apply when instructed Next steps © UKAS October 2014

32. CPA is a UKAS company For information updates twitter.com/UKAS linkedin.com/company/united-kingdom-accreditation- service youtube.com/ukastv Follow us on LinkedIn and Twitter Visit ukas.com to subscribe to CPA newsletter © UKAS November 2014

33. CPA is a UKAS company Questions?

34. CPA is a UKAS company The Assessment Visit UKAS Processes John Ringrow – Senior Assessment Manager