Passing CAP Inspections 2011
Passing CAP Inspections 2011
Passing CAP Inspections 2011
www.cap.org
Don’t Pull out your hair;
• Quality Control
• Correlation
• Calibration/Calibration Verification
o Follow manufacturer instructions
o Calibration verification every 6-month not necessary unless
required by manufacturer
• Reagents
o Lot-to-lot reagent validation not required
o Follow manufacturer instructions for handling &
validating
• Competency
o During 1st yr that an individual is performing
patient testing, competency assessed at least
semiannually
o Competency must at least be reassessed
annually
www.cap.org
CAP Point of Care
o Proficiency Testing
o Instrument maintenance
o Procedure manuals
o Personnel
o Specimen Handling
o Results reporting
o Safety
• Evidence of Compliance
• ROAD
©2010 College of American Pathologists. All rights reserved. 11
Proficiency Testing
POC.03225
• For tests that CAP doesn’t require PT, lab can
participate in external PT/alternative assessment
o Perform semiannually
o Perform on tests for which PT isn’t available
– Ungraded proficiency surveys
– Split sample (with reference or other labs,
established in-house method)
– Assayed material
– Regional pools
– Clinical validation by chart review
– Other suitable & documented means
POC.03250
• Testing personnel must participate in PT
o Don’t have to get everyone every year
POC.03275
• Review results in a timely manner
o Within 1 month (prompt and timely)
o Investigate unacceptable results
o Solve any problems/document corrective action
o Retain records for 2 years (unless specific
discipline requires longer)
o Acceptable or good
Other Considerations:
POC.07037
• Follow manufacturer instructions for frequency
• QC must be acceptable/documented prior to
release of patient data
• Evidence of corrective action when QC exceeds
tolerance limits
• Internal control results need not be documented for
instruments using such controls, if there is a ‘lock
out’ feature
• Specific QC Requirements:
• Evidence of Compliance:
POC.07568
• Must be performed for all non-waived instruments or
methods twice/year
o QC comparison for tests on the same instrument,
using same QC lot#/manufacturer
o Use of fresh patient samples is preferred, but not
required
POC.07568
• Perform twice/year
• Use fresh human samples unless specimen stability is
an issue
• If must use QC or reference materials, verify they
respond the same as a patient sample
• Single-use devices can use alternative approach
• Must be defined
• Revalidate at least every 6-months & reagent lot
changes
• Does not apply to coagulation tests
POC.08500
POC.08500
• AMR Validation of Single-use Devices (non-waived):
and
Documentation
Policy in manual could assist with the inspection
www.cap.org
Where do I start?
General Items:
• Reagents labeled
• Patient results and reporting process
• QC, maintenance, and function checks
• Mechanism to determine the testing personnel
• Training & competency records
• Procedure manual in each POC testing area
o Evidence personnel are knowledgeable of
where procedure is located and contents
• Proficiency testing
Is this a deficiency?
Is this a deficiency?
• Is this a deficiency?