In 1988, I started as a flow cytometry tech at Wake Forest Baptist Health (WFBH) in Winston-Salem, NC.  Over the years I been through numerous College of American Pathologist (CAP) inspections and have also served as a lab inspector.  These experiences have taught me a thing or two about preparing a flow cytometry lab for the CAP inspection.  Many deficiencies are easily avoidable and require minimal effort to correct, especially compared to effort required to defend a Phase II deficiency to your medical director or laboratory supervisor.  Here is my list of the five most common and easily avoidable mistakes made in preparing for, and participating in, a CAP lab inspection.  

#1: Improper use of personal protective equipment (PPE) and general cleanness.
 
These are perhaps the most preventable of all errors.  Bad habits of not using PPE in everyday work and generally sloppiness are hard to compensate for in a surprise inspection.  Often a dirty centrifuge liner has been overlooked.  Make sure that all personnel realize the importance of proper use of PPE and stressed that it must be used at all times.  Reevaluate the clean areas and biohazard area in the work area for ease of use.  Maintain cleanliness of workstation and equipment throughout the day. 

#2: Incomplete documentation of QC maintenance records.

Say what you do and do what you say.  A single missing day can lead to a deficiency.  Typically, someone did not get around to checking off the form for a particular day.  Even if you did not run an instrument on a particular day, an entry should be made documenting this.  If it was due to an instrument malfunction, that should be reflected in the action log.  In addition, you need to have the preventive maintenance records for all of your instruments readily available on inspection day.  Some labs do not have these documents on-site.

#3: Quality control (QC) verification not sufficient for all test analytes performed.

QC verification is one of the most important factors of a CAP Inspection. You must have verification records of all tests and analytes that you are using.  There are market ready controls for some analytes, but not all.  For those analytes that are not available you should contact other laboratories to share samples to use for positive staining to evaluate the performance of the antibody that you are using.  You can also check your antibody performance by parallel testing with other methods such as nTdt by Flow with immune-histochemical staining for Tdt.  Make sure that all procedures and methods reflect what you are doing in the laboratory on a daily basis, and that there is accurate recording of information.

#4: Incomplete competence records of performance technologist evaluation.

All flow personnel must have evidence of competency for all testing performed.  Prepare annual review and testing documents for flow tech performance.  Make sure that you have a document prepared that shows the span of each technologist experience and responsibilities for testing.  For new technologists, be sure that there is a documented ongoing training process.  For ideas on making a competency check list you can refer to the 2006 Bethesda International Consensus Recommendations on the immunophenotypic analysis of Hematolymphoid neoplasisa by Flow Cytometry: Recommendations for Training and Education to Perform Clinical Flow Cytometry by Brudce Greig, Teri Oldaker, Michael Warzynski, and Brent Wood… Cytometry Part B (Clinical Cytometry) 72B: S23-S33(2007).
 

#5: Lack of correlation between copies of the procedure manual.

If you have electronic and paper versions of the procedure manual, they MUST be identical.  Ongoing review and revisions must be documented and correlate between the versions.  An update form in front of the manual will help remind lab personnel to make changes in both versions.  Removal of old procedures is crucial as well.      

Probably the best way of avoiding all of these common mistakes it to prepare for CAP inspection.  I can’t say don’t sweat the small stuff because I have walked into some of the best laboratories and opened up the refrigerator door only to find uncovered samples tubes and out dated reagents.  So I would say prepare for the worst, but on the day of inspection enjoy the process by allowing free communication of experience and knowledge to be gained and shared.  The CAP Website (www.CAP.org) is a great resource for getting any information that you would need for preparing for an unannounced inspection, continuing education material, proficiency testing input and review, and also guidelines for the inspector who will be performing an inspection.  There is other helpful information on the website such as; your custom checklist, what’s new on the checklist and notes to help you interpret your checklists.  There is also a section which answers frequently asked questions about unannounced inspections.  You can obtain a personal login and keep up with everything yourself.  It is instrumental in telling you exactly what you need to do and suggest a helpful time line so you can prepare and maintain your lab proficiently between inspections.

My experience as a CAP Inspector has been a great way for me to observe and gain valuable information that could help our flow laboratory.  When I began inspecting in 1995 you just needed to have some knowledge of the flow lab to be an inspector.  Now inspection teams have access to a list of qualified or certified inspectors who specialize in the area of flow.  Because there are not many certified flow inspectors in North Carolina, I receive calls somewhat frequently.  There is definitely a need for more certified flow inspectors, because we all like to be inspected by a person who really knows and understands our day to day work requirements.  Why not sign up!  Everything can be done on line: reviewing materials, taking training classes and maintaining your active inspector status.

Let me know if you have a story about getting prepared for an inspection that you think other members might find useful.

Natalie Walker
Wake Forest Baptist Health