1. Lara Cresswell ACGS workshop May 16 th 2014

2. Overview Our CPA/UKAS journey including timescales Key gaps identified Personal experiences Not an expert Describe the process we went through Currently awaiting decision following evidence submission Still have evidence to submit

3. The Leicester lab Cytogenetic only laboratory, 16.8 WTE Part of Leicester/Nottingham pathology JV Empath CPA full assessment in 2009 Surveillance visit 2011 Full CPA assessment visit was due April –October 2013 Slipped timescales due to UKAS transition UKAS application forms requested April 2013 – Including AC4 form August 2013 – date set for Feb 2014 – expecting a CPA visit with ISO as an add on

4. Slipped timescales.... A recurring theme Jan 2014 New assessment manager assigned Agreed dates not possible Peer assessor confirmed and new dates set for March 2014 3 day visit March 3 rd -5 th Both assessors being observed as first 15189 visits

5. Pre visit documentation Big difference between CPA and UKAS/ISO AC4 form Difficult, very little guidance on completion Easier if have lists of tests AC4 form includes related SOPs to the tests listed on the form, these must all be submitted (~40 SOPs) Gap analysis must be submitted Quality manual Latest AMR Documentation requested by Feb 1 st 2014

6. Gap analysis Key preparation document for the visit Took a simple approach Spreadsheet with all the standards listed out – Considered how we fulfilled each standard and documented the evidence and described the gaps – RAG rated each standard – Used this as a working document and action plan assigning timescale and responsibilities Completed gap analysis mid Dec 13 – Would have been better to do this earlier – Knew wouldn’t be able to address all the gaps before the visit

7. AC4 form Key document for 15189 accreditation Forms schedule of accreditation Must list all tests you do and the related equipment Important to state if you do in house calibrations Ensures correct assessment team available Original form rejected early Feb 14 (not detailed enough) Had to resubmit following limited guidance! AC4 form accepted by UKAS late Feb

9. Pre-visit reading Documents on UKAS website giving details on the visit format Technical policy statements Guidance documents in technical information section GEN3 (reporting UKAS assessments) very useful Includes details on timescales for submission of evidence

10. Visit plan Assessment manager issued a visit plan Should be sent 4 weeks prior to visit – Received with 1 working day to go! Visit plan lists what the AM and PA what to see – Plan from there to try and make all processes available Everything on the AC4 form is witnessed Challenging to cover everything in 3 days

11. Visit plan with AM interviews and document assessment ISO 15189 management requirements, to include: Introductory meeting Management and organisation – roles and responsibilities, including TPS 51 multi-site requirements Annual Management Review and other meetings Interviews with senior management, as appropriate( to be confirmed) Document control including documents from external sources Service agreements Referral of testing and approval of service providers Purchasing services and supplies – including evaluation of suppliers and supplier list Complaints Nonconforming work, corrective and preventive action Record control On-going evaluation including quality objectives and assessment of user feedback, quality indicators and KPIs Breadth of internal audit and depth of internal audit reports HR policies and associated staff records and mandatory training LIMS CPA C5 (H&S standard)

12. Visit plan with PA witnessing and document assessment ISO 15189 technical requirements, to include: Staff competence – initial training and on-going EQA/IQC – coverage, performance and suitability of test assurance package Method validation and verification including conclusions on fitness for purpose of methods Method Content General accommodation and environment Technical records – clarity and traceability User information, sample reception and handling including records and evaluation of sample suitability Equipment, reagents and consumables management Reference materials and traceability Uncertainty of measurement Interpretation, reporting of results and advisory services

13. Day 1 witness plan with PA Culturing processes (includes harvesting and slide making) Using the following items of equipment Across a range of different sample types as appropriate to assess the different competences in required. Biological safety cabinets NC026, NC027 Centrifuges NC018 Incubators (SOP in progress) Hanabi metaphase spreader NC089 Light microscopes NC083 Inverted microscope NC090 Dissection microscope NC091 Analysis by- G banding NC038 MMC stress testing NC098 SCE staining NC115 Using Light microscopes NC083 Cytovision image analysis system NC085, NC087 Analysis/reporting processes NC009, NC040, NC041, NC042, NC050, NC071, NC131, NC143, NC144 Day 2 and 3 covered FISH, Karyotyping, image analysis, array scanning and analysis and plasma cell selection

14. The visit Private room for the assessors including computer access and availability of paper record Free access to system meant not always seeing all the evidence, better when guided Provide lunch and refreshments Opening meeting – Register of attendees – Had senior Empath representation Time is very tight – No time for tour of the lab – Remember to point out models rules for visitors etc – Generally followed the plan! – Supportive approach from the assessors

15. Our approach to the visit.. Regular staff meetings prior to visit Very useful if have visit plan 4 weeks before Encouraged an open and honest approach Acknowledged where evidence thin No time to go on an evidence ‘hunt’ Assessors will know this anyway from the gap analysis This approach was appreciated by the assessment team and conveyed to all staff

16. Improvement Actions Ongoing process throughout the visit Given the IA form after each day to populate how the action will be cleared, this is agreed with the assessment team – NOT an advisory service Still get the IA even if fix the problem straight away 40 improvement actions in total – All mandatory findings

17. Key IAs Audit timetable must be in line with 15189 – must ensure completion of the timetable No criteria for selection and monitoring of suppliers Insufficient change management documentation More detail for external documents, quality and process records Insufficient validation data – Historic processes Laboratory information management – Insufficient documentation for all systems BUT... Nothing was identified that was not on the gap analysis

18. Closing meeting All staff present Brief overview of the visit Confirmation of identified actions Recommendations for accreditation – Retain CPA but not 15189 yet! Clarification of timescales to submit evidence Timescales for revisit – 3 months from last submission date Statement of resource UKAS need to clear evidence – 1 day each AM & PA – Confirm when the assessment report should be available

19. Evidence submission CPA/ISO finding – 8 weeks from final date of assessment To allow clearance within 12 weeks to retain CPA ISO only finding - 12 weeks No negotiation on these dates Audited by UKAS Evidence is submitted electronically Separate submission forms for AM & PA

20. Where we are... 30 April submitted evidence for 33/40 findings Should hear within 10 working days 28 May for final 7 findings Will be assessed for 15189 at follow up visit in August

21. Key gaps Selection and monitoring of suppliers Change management Equipment, reagents, external services, LIMS Laboratory information management Quality manual not in 15189 format Had cross referenced 15189 on CPA manual Unique identifiers on all internal and external documents including trust policies Need Q-pulse (or similar)! Own a copy of the standards no copies!! BSI group access in pathology

22. Uncertainty of measurement Identified as a gap Most difficult aspect for a subjective discipline IA required submission of how we will evaluate uncertainty and submit evidence for 2 processes Open to interpretation as no specific guidance Awaiting outcome on our approach

23. Summary Overview of the process Significant amount of work involved Recommend starting early! Identified key gaps Flavour of the improvement actions Required evidence needs to be more robust than for CPA Fingers crossed for a positive outcome!!