The College of American Pathology (CAP) is one of the accrediting bodies that ensures histology labs follow a uniform standard of safety, to ultimately ensure the best patient care is provided. Learn more about all of the regulatory agencies with jurisdiction over the histology lab in this previous post. Though there are many, CAP is the most popular for labs in the US.
CAP inspections are pretty specific to your laboratory, for both you and your inspector. Inspectors are provided a list of the equipment your lab is using, the menu of activities that your lab performs, as well as information about your previous inspection. As the lab being inspected, you receive a checklist specific to the work your lab performs to help you prepare.
You’ve reviewed your checklist, and done your best to prepare, but what happens if your lab does not pass with flying colors? You may get a deficiency. There are two types of deficiencies.
Phase I Deficiency: Phase I deficiencies require a written response indicating the corrective action taken. These can generally be done on site during the inspection.
Phase II Deficiency: Phase II deficiencies also require a written response but also need supporting documentation demonstrating compliance. You have 30 days after the date of the on-site inspection to provide CAP with deficiency responses.
Whether it is a phase I or a phase II is listed on the standard next to the standard number and topic so you will easily know which type of deficiency something is. So how do you get a deficiency for a particular standard? What do CAP inspectors look for?
In general, CAP inspectors are looking to verify that all work is done accurately and safely, that you meet the accreditation standards put in place by CAP, and that your work practices match your policies and procedures. Policies and procedures matching your work practices is where a LOT of deficiencies happen. For example, if you have a procedure that says you perform equipment maintenance weekly, does your equipment maintenance QC form reflect that policy? Even having “as needed” on the QC form when your policy specifies daily, can cause a problem. Similarly, CAP doesn’t require open dates on reagents, but if your policy says you record open dates on bottles and they’re not there, that is a problem, because your policy does not match the work you’re actually doing. If you need examples of protocols, policies, checklists, and quality control forms, NSH members have free access to a library of downloadable resources that you can use to create documentation that holds up to CAP inspection!
Here are a few other things to pay close attention to!
Make sure that you have documentation for both what is listed in the standard and what is listed in the evidence of compliance for that standard. For example, if the standard says you need a policy for XYZ and the evidence of compliance for that standard says you need a quality control plan for XYZ, you should have both. You can’t solely go by the evidence of compliance section.
CAP puts out updated versions of their checklists periodically, so there may be new or revised items since the last time you were inspected. Inspectors will pay close attention to these new standards as these are often missed by labs.
In the information that inspectors receive about your previous inspection, they are provided with any previous deficiencies that have been found, and you can bet they will be looking to make sure that those deficiencies remain corrected so double check anything you have been cited for in the past.
Learn more about CAP deficiencies (and earn 1 CEU!) by viewing the webinar, CAP Inspections - Smooth Sailing or Stormy Seas? An Inspector’s Perspective, part of the 2020 Virtual Convention Laboratory Operations Package, a 5 webinar bundle that includes 5 of the most popular laboratory operations webinars from the 2020 NSH Convention.