Update: CAP Inspections for CLIA-Licensed Laboratories, Virtual Inspections Added

Communication Date: October, 2020
NOTE: The information below was current at the time of communication. Subsequent CAP changes, if applicable, are not reflected in this eAlert.

For the latest on CAP inspections, please visit: 2020 Modified Inspection Processes

Throughout the COVID-19 pandemic, the College of American Pathologists (CAP) has been working to help you navigate the unique complexity and compliance requirements of SARS-CoV-2 testing along with your everyday high-quality laboratory management and testing for patients. We hope you found the many resources added to our website, webinars, and new proficiency testing helpful.

We delayed conducting inspections as a result of the public health emergency. Now, with approval from the Centers for Medicare & Medicaid Services (CMS), the CAP is ready to add virtual inspections to our inspection model:

• Virtual inspections are a temporary process implemented in response to the COVID-19 pandemic to allow the CAP to safely and expeditiously meet our regulatory obligations and ensure our accredited laboratories remain in continuous compliance with accreditation requirements.
• Virtual inspections will still include all the elements of our traditional on-site inspections, only they will be conducted over videoconference platforms instead of in-person and will require a subsequent on-site inspection within 4- 6 months, or as soon as it is practical and safe to do so.
• The subsequent on-site inspection is a statutory requirement under the Clinical Laboratory Improvement Amendments (CLIA) Law and Regulations.

To participate in virtual inspections, laboratories must be in good standing and meet the following criteria:

• Have reliable Wi-Fi and a laptop, tablet, or smartphone enabled with a camera, microphone, and speakers that can be taken into each laboratory area AND
• Be under current traveler restrictions for the state where the laboratory to be inspected is located that requires non-resident travelers to quarantine for a minimum of 14 days upon arrival OR
• Have a >5% positivity rate of COVID-19 infections in the state in which the laboratory to be inspected is located OR
• Travel/visitor restrictions have been put in place by the institutions of either the laboratory or the inspection team.

We will be prioritizing laboratory inspections that are overdue and customers awaiting their first CAP inspection. We will then proceed with contacting laboratories who have inspections coming due in 2021, which may also be conducted virtually with a later on-site inspection.

We have been piloting virtual inspections and the pilot is going well! Here are some highlights of what to expect:

• Both the laboratory director and the inspection team must agree ahead of time to perform the inspection 100% virtually.
• The process will require laboratories to provide electronic documents to the inspection team for review as well as be able to facilitate, and participate in, some method of live video observation of laboratory practices.
• The laboratory director and the team leader will discuss which technologies/platforms to use to accomplish the document review and live observation of laboratory practices (Skype, Microsoft Teams, Zoom, FaceTime, or GoToMeeting).
• The laboratory director and team leader will determine the inspection date range. Inspections will be comprised of dedicated blocks of time over a few days rather than completing the inspection in a single day.

The CAP assignments team will be contacting assigned inspection teams and laboratories with instructions and information about scheduling and planning for your virtual inspection. As our team works on scheduling and planning overdue inspections, please be reassured your currently accredited laboratory will remain CAP accredited.

Thank you for your patience and understanding as we work through these challenging times together. Should you have questions, please contact lapassignments@cap.org.