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.
• 10.00 – 17.00: Vertical and horizontal audits.
Interviews/chats – Quality Manager, staff.
• [12.00 – 13.00: Meetings: Users, Senior
Manager.]
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]
Preparation for Inspection
• Paperwork
• Taking some effort.
• Staff up to speed.
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.
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.
Cleaning the Environment
• Laboratory staff are
natural hoarders!
• PCs, old analysers,
chemicals, anything
electrical. Nothing
gets thrown away!
Most “Stuff” Just Costs “People
Time”
• Annual appraisal for
all staff.
• Thermometer checks
for fridges.
• Fume cupboards flowmetered.
• Electrical safety
checking.
• Dave the painter ….
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.
Communication
• Vital success factor is
communication with
our staff.
• Also to our users.
• Many laboratories
clueless about
communication.
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.
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 coassessor moving in.
• 10 easy to correct non-compliances better than
1 mega-problem.
• Support staff and stop any defensiveness.
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.
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.
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.
People Who Will Almost
Certainly be Interviewed
•
•
•
•
•
Consultant
Head BMS
Quality Manager
Trainee
Most recent “starter”
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.
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.
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.
Closing Meeting & Non
Compliances
• You decide who attends.
e.g Consultant, Clinical Scientist, Head
BMS & Deputy, Quality Manager.
• Some assessors throw out more noncompliance forms than others – depends
on their lateral thinking and level of
sadness!
Summary
• Basics up to speed.
• Documents a tool not the solution.
• Understanding the quality system crucial