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- How to Survive CAP Inspections: A Guide for Pathologists and Laboratorians
Maybe you just finished training and suddenly find yourself serving as CLIA laboratory director. Or maybe you would simply like a refresher after the disruptions of COVID-19. This guide draws on years of experience from team leaders and inspectors of laboratories small and complex, national and international. It was prepared as a quick guide so you can feel confident for your next inspection.
1. Take the interim inspection seriously.
This is your chance to address any major issues before the formal inspection. The interim inspection is evaluated in multiple checklists, and inspectors will pay extra attention to any deficiencies. The same attention will be applied to deficiencies from past inspections. Remember, recurring deficiencies cannot be corrected on site.
2. Watch out for last minute changes.
Deficiencies related to the activity menu are one of the top cited. The CAP must be notified if there are any changes to the activity menu. Don't forget to make sure relevant checklist items are compliant if there are any additions. Try to avoid changes in leadership if at all possible. If these changes are inevitable, make sure new leaders are competent and knowledgeable. If the laboratory director changes, there is a defined period where policies and procedures must be reviewed.
3. Consider your "go-to" people.
The "go-to" people are knowledgeable and experienced supervisors that inspectors go to with questions and assistance in obtaining documentation. Ensure enough redundancy so that another supervisor can step in if the primary person is unavailable. You definitely do not want to accumulate deficiencies because the only person able to assist is in the emergency room on inspection day! These situations have happened before, and it's essential to be prepared. Make sure laboratory staff are also aware of the right go-to people in case they are approached by inspectors with questions they are unable to answer.
4. Make sure documentation, competency assessments, and personnel records are easily accessible.
One of the most cited deficiencies relates to competency assessment. If inspectors do not receive the records before summation, they will have to cite a deficiency. Sure, you may be able to find the documents after the inspection, but better to practice good document management.
5. Streamline the process for your inspectors.
Have a checklist ready with answers to every single item—either the answer itself or where to easily find the it. The supervisors of each laboratory may keep annotated checklists or electronic annotated versions may be provided to inspectors. Laboratories using that strategy tend to have easier, faster inspections with fewer deficiencies.
Also consider logistical issues for your inspectors, particularly if your laboratory has multiple CLIA sites that will be inspected at the same time. It's important to realize your inspectors will likely be unfamiliar with the area. You want the team to maximize their time performing a high-quality and thorough inspection, not fumbling with directions and getting lost. It’s worth the effort to assist with directions and transportation between sites.
6. Recognize that some deficiencies are inevitable.
Of thousands of checklist items, one can expect a few deficiencies. More complex labs with dozens of checklists would be expected to have more deficiencies. The key is avoiding recurring deficiencies and always prioritizing patient care and safety. The regional commissioner reviews and accepts responses. Know that the CAP takes your feedback seriously. All feedback reports are reviewed and follow-up provided.
CAP inspections thoroughly examine every discipline within your laboratory, ensuring a rigorous standard of quality, accuracy, and safety. They also offer the opportunity to observe, learn, and exchange best practices with inspectors from a variety of laboratory environments. Keeping the above points in mind can help you prepare and enter the inspection process with confidence to reap the full benefits.
Diana Lin, MD, FCAP, is CAP commissioner for the state of Alabama and division commissioner for the Florida Panhandle Region. She serves as an inspection team leader and reviews CAP checklists annually. She is also a member of the CAP Practice Management Committee. Dr. Lin is an associate professor of pathology at the University of Alabama at Birmingham and section director of anatomic pathology at UAB Highlands Hospital.
Dr. Litovsky, MD, FCAP, served as a CAP state commissioner from 2008–2022 and has years of experience as an inspection team leader. He is currently a professor of pathology at the University of Alabama at Birmingham with a special interest in cardiovascular pathology and medical and resident education.