Getting Through those CPA Inspection Blues

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

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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.

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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

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Preparation for Inspection

• Paperwork
• Taking some effort.
• Staff up to speed.

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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, HS etc-
• No scraps of paper in pockets or notebooks.

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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.

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Cleaning the Environment

• Laboratory staff are natural hoarders!
• PCs, old analysers, chemicals, anything
  electrical. Nothinggets thrown away!

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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 .

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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.

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Communication

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

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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.

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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.

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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.

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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.

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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.

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People Who Will Almost Certainly be Interviewed

• Consultant
• Head BMS
• Quality Manager
• Trainee
• Most recent starter

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Those Audits .

• Vertical UE, 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.

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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 HS, cross-references in
  SOPs. Others more laid back!
• Contact Lead Assessor beforehand - sort out
  assessor personal preferences paperwork,
  interviews, what staff in final meeting.

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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.

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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!

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Summary

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