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For CAP-Accredited Laboratories

• The College of American Pathologists is advocating for pathologists and laboratories in the wake of the outbreak of respiratory disease caused by a novel (new) coronavirus that was first detected in China. The virus has been named “SARS-CoV-2” and the disease it causes has been named “coronavirus disease 2019” (abbreviated “COVID-19”).
  
• The CAP is providing the following guidance for CAP-Accredited Laboratories to ensure availability of reliable testing for rapid detection of the agent that causes COVID-19. Also, please review this from the FDA on March 16: Coronavirus (COVID-19) Update: FDA Provides More Regulatory Relief During Outbreak, Continues to Help Expedite Availability of Diagnostics

CAP US Inspections

• Your inspection may be delayed per CMS: CAP Inspections COVID-19 Update
• Self-inspections: 30-day extension to all laboratories that have a self-inspection due by May 1, 2020
• The College of American Pathologists (CAP) has successfully petitioned the Centers for Medicare and Medicaid Services (CMS) to suspend all inspections except Immediate Jeopardy Complaint inspections (and associated follow-up revisit inspections) through April 10, 2020. Read more here. The CAP continues to petition CMS to suspend all routine on-site inspections during this national state of emergency due to the COVID-19 pandemic, and we continue to work with our laboratories and inspection teams to reschedule inspections based on local, state and federal social distancing guidelines and stay at home/shelter in place orders. During this time, impacted laboratories will remain CAP accredited. Additionally, to maintain quality and safety during this time, impacted laboratories should continue proficiency testing (PT) participation and follow all CAP requirements. This will be evaluated on an ongoing basis and could potentially be extended depending on how the situation evolves.
  

For laboratories that are EARLY in their inspection window

We are working with your assigned inspection team leader to ensure they are aware of and comply with any state or institutional restrictions. We will make every effort to complete your inspection within your inspection window, but as this COVID-19 situation is fluid, there are no guarantees. Should it become necessary to delay your inspection after your anniversary date, the CAP will work with you and the inspection team to reschedule your inspection as soon as possible.

For laboratories that are LATE in their inspection window

We are contacting laboratories and their assigned inspection teams to understand any state and/or institutional restrictions on visitors and will help to coordinate communications between the laboratories and inspection teams. This communication is crucial to ensure that your inspections are properly rescheduled. Once the CAP is able to resume inspections, we will notify your team leaders and laboratory directors and set up conference calls for you to discuss rescheduling your inspections. If you have any questions, please contact the LAP Assignments team at LAPAssignments@cap.org.

CAP Inspections Delayed Internationally

• Self-inspections: 30-day extension to all laboratories that have a self-inspection due by May 1, 2020
• Internationally, the CAP has postponed all scheduled and requested laboratory inspections until at least June 1, 2020. During this time, impacted laboratories will remain CAP accredited. Additionally, to maintain quality and safety during this time, impacted laboratories should continue proficiency testing (PT) participation and follow all CAP requirements.

For Inspection Teams and Laboratories Scheduled for Inspection

• Your health and safety is of utmost importance to us during this time of uncertainty with the coronavirus outbreak and we are continuing to monitor the situation. We will update impacted laboratories and inspectors regarding rescheduling. We appreciate your patience.
  

For CAP PT Customers

New PT Program for the Detection of SARS CoV-2. Read more

The CAP is committed to working with your laboratory to manage kit deliveries, stability concerns, and regulatory requirements, just to name a few. To date, the CAP has taken the following actions:

• We are delaying some shipments.
  • We continue to monitor international restrictions and to hold shipments, when possible.
• We are extending due dates, when possible.
  • The CAP will automatically extend due dates for international customers when shipments are released.

Printed participant summaries and evaluations will continue to be mailed to laboratories, but they may be delayed.

For laboratories that may have limited staff or are temporarily closed, you will need to arrange to receive shipments that the CAP is unable to delay. 

Per the Centers for Medicare & Medicaid Services’ (CMS) Clinical Laboratory Improvement Amendments (CLIA) Laboratory Guidance During COVID-19 Public Health Emergency document, “in the event where a laboratory temporarily suspends performing a specific test due to staffing shortage, supply shortage, or reagent shortage:

• The laboratory must document the timeframe during which the test is not being performed, and the reason therefore.
• The laboratory must notify the inspecting agency and PT program within the timeframe of submitting PT results that it has ceased testing, and the reason therefore.
• If the laboratory is still performing, or resumes such testing, and providing patient results, PT is still required and must be performed, as required by the CLIA regulations.” 

If your laboratory is currently unable to perform testing, hold the material and use it for alternative assessment when routine testing circumstances resume. If your laboratory is holding material for testing beyond the kit due date, use exception code 11 on your result form to indicate your laboratory was unable to analyze the specimens and document the reason in the Use of Other section. You do not need to call the CAP to use this code. 

For more information, please access the following:

• Current list of shipment delays
• My PT Shipping Calendar (a current, customized list of your laboratory’s shipments and updated due dates)
  • For access, click Access e-LAB Solutions Suite, then click My PT Shipping Calendar on the lower left-hand corner of the page.
• Expected 2020 Shipping Dates
• CAP Responds to Your COVID-19 Questions

COVID-19 Resources

• COVID-19 Autopsy Guideline Statement from the CAP Autopsy Committee Read the Statement
• A Remote sign-out of cases with Digital Pathology FAQs published. Read the FAQs
• Subject matter experts from the Informatics Committee compile resources for COVID-19. Read more
• The Cytopathology Committee offers some considerations for cytopathology services during COVID-19. Read the update
• Transfusion, Apheresis and Cellular Therapy Committee provides information on concerns for the national blood supply. Read the update

CAPcasts

Listen to COVID-19 experiences, guidance, and advice.

Diagnosing COVID-19: How OHSU Pathologists Launched Testing in 15 DaysIn this CAPcast interview, Richard Scanlan, MD, FCAP discusses his experiences bringing COVID-19 testing online at his institution, including some lessons learned. Dr. Scanlan is the medical director of the Oregon Health and Sciences University Hospital laboratory in Portland, Oregon.