CAP Accreditation Update: COVID-19

The College of American Pathologists (CAP) understands the pressures you face with COVID-19. As the situation is fluid, we’d like to share some of the most recent changes that may impact you as a CAP-accredited laboratory:

An organized advocacy campaign led by the CAP persuaded the federal government to allow pathologists to work remotely. Read more. Under the CLIA regulations, a CLIA license is needed wherever a pathologist is physically sitting when making a primary diagnostic interpretation, whether using telepathology or reading a physical slide. Due to the public health emergency posed by COVID-19 and the urgent need to expand laboratory capacity, the CMS agreed to exercise its enforcement discretion to adopt a temporary policy that will allow pathologists to work remotely under certain conditions.

What this means:

• Under the Centers for Medicare & Medicaid Services (CMS) enforcement discretion, CMS will now allow pathologists to remotely review and report laboratory data/slides/images.
• With this temporary change, CMS will not require a separate certificate for laboratories that are in a temporary testing site (a location used to perform laboratory testing such as a pathologist’s home) provided that:
  • The designated primary site or home base has a current certificate (of registration, compliance or accreditation).
  • The scope of work performed falls within the primary site’s certificate.
• The temporary site must comply with other applicable federal and state laws including HIPAA.
• This guidance does not apply to pathologists who have already obtained CLIA certificates for their home or other locations separate from the primary testing site.

Get accreditation updates on the CAP’s COVID-19 page, including:

• Guidance to ensure availability of reliable testing for rapid detection of the agent that causes COVID-19
• Information on inspection delays: CMS suspends most inspections until April 10, 2020
• Updates on self-inspections: CAP grants 30-day extension to all laboratories that have a self-inspection due by May 1, 2020

As we learn new things daily, and respond to your questions, we are compiling the questions and answers for you. Have a question? Please contact us at accred@cap.org.

We appreciate your dedication and efforts in these difficult days. Thank you for being a CAP-accredited laboratory.