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

Getting Through those CPA Inspection Blues Dr Jonathan Berg City Hospital, Birmingham. CPA Inspection – Day 1. Day 1 08.00 – 10.00: Opening meeting,walk round department, Interviews with Lab Manager and Consultant.

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

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  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. Nothinggets 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 2nd. • 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

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