1. Getting Through those CPA Inspection Blues Dr Jonathan Berg City Hospital, Birmingham

2. CPA Inspection – Day 1 Day 1 08.00 – 10.00: Opening meeting,walk round department, Interviews with Lab Manager and Consultant. 10.00 – 17.00: Vertical and horizontal audits. Interviews/chats – Quality Manager, staff. [12.00 – 13.00: Meetings: Users, Senior Manager.]

3. CPA Inspection – Day 2 Day 2 08.00 – 12.00: Finish audits and interviews, home in on problem areas. 13.00 Onwards: Writing up. 14/16.00: Closing Meeting [12.00 – 13.00: Meetings: Users, Senior Manager]

4. Preparation for Inspection Paperwork Taking some effort. Staff up to speed.

5. Paperwork & Document Control Quality Manual –Check all staff have read it – especially consultants! –All copies the same version. Document Control Systems – Commercial SOPs –In use and appropriate people can locate, Up-to-date, signed, no handwritten changes. –Cross-referencing to COSHH, H&S etc- –No scraps of paper in pockets or notebooks.

6. Take Some Effort Meetings up-to-date. Pre-inspection health check - clutter under benches, minor decorating, reagent checks, appraisals done, file of clinical audits. Laboratory audits – staff familiar with process and be relaxed about audit.

7. Cleaning the Environment Laboratory staff are natural hoarders! PCs, old analysers, chemicals, anything electrical. Nothing gets thrown away!

8. Most “Stuff” Just Costs “People Time” Annual appraisal for all staff. Thermometer checks for fridges. Fume cupboards flow- metered. Electrical safety checking. Dave the painter ….

9. Staff Up to Speed Newsletters, Noticeboards & Meeting Minutes: Make liberal comments on all the hard work. Everyone Must Know: Who the Quality Manager is, key features of Quality System, management structure…. Changes in Laboratory: Everyone aware of up-to-date party line. Staff looking forward to visit.

10. Communication Vital success factor is communication with our staff. Also to our users. Many laboratories clueless about communication.

11. Inspection - Take Control Opening Meeting with staff – who should go and where held? Your call. What does the Assessor want out of the visit? Deliver on personal interests Not a lot of time – with planning can be even less. POCT always of interest.

12. Inspection Day Control Subconscious pressure on assessors to find non-compliances. You will know when they find something – they need to confirm - watch for the tangents and co- assessor moving in. 10 easy to correct non-compliances better than 1 mega-problem. Support staff and stop any defensiveness.

13. Meeting with Hospital Manager No one from laboratory should attend. Brief Manager on level of likely questions. Update 30 minutes before with any emerging issues. Have a reserve Manager if the CE! Possible Topics: Investment, future direction, consultant appraisal, 24 hour consultant cover and issues that have come up.

14. The Poisons Cupboard 1.2 kg cyanide – what is this for? Easy pickings for the CPA inspectors! COSHH assessment is easier if you only have chemicals that you use.

15. Pre Inspection Checklist Things like: Annual appraisals all done. Reagents all in date with stock control. No bits of paper in lab coat pockets acting as SOPs. Sell yourself with the basics accessible on the day.

16. People Who Will Almost Certainly be Interviewed Consultant Head BMS Quality Manager Trainee Most recent “starter”

17. Those Audits …. Vertical – U&E, TSH, HBA1C, n = 2 Horizontal and Observational – Sample bench, sending away procedures, Health and Safety. n = 3-4 Paperwork for new style inspection – where it normally is, not in assessors room.

18. Assessors are Different Gauge their experience at an early stage. Are they working to the new standards or modified old system? Some keen on detail – H&S, cross-references in SOPs. Others more laid back! Contact Lead Assessor beforehand - sort out assessor personal preferences – paperwork, interviews, what staff in final meeting.

19. Assessors Need Help They want to write nice things in the summary. Problems picked up by one assessor will be checked by the 2 nd. Not there to get you a new analyser or knock down a wall. Usually keen to wrap up early on Day 2.

20. Closing Meeting & Non Compliances You decide who attends. e.g Consultant, Clinical Scientist, Head BMS & Deputy, Quality Manager. Some assessors throw out more non- compliance forms than others – depends on their lateral thinking and level of sadness!

21. Summary Basics up to speed. Documents a tool not the solution. Understanding the quality system crucial