The College of American Pathologists (CAP) has successfully petitioned the Centers for Medicare & Medicaid Services (CMS) to suspend all inspections except Immediate Jeopardy Complaint inspections (and associated follow-up revisit inspections) until further notice. In accordance with this decision by CMS, the CAP has suspended all routine inspections during the national state of emergency due to the COVID-19 pandemic, and we are working with our laboratories and inspection teams to reschedule upcoming inspections based on current local, state and federal guidelines for social distancing and stay at home/shelter in place orders. Once the CAP resumes routine inspections, laboratories will receive prior notification of the inspection date to ensure the inspection can occur as planned.
The CAP also requested that the CMS temporarily allow pathologists to utilize remote sign-out for pathology interpretation/diagnosis and allow other licensed health care professionals to utilize remote data reviews. Allowing this flexibility was authorized by the CMS. The CAP believes this allows laboratories to employ appropriate protocols to reduce the risk of infection among their own teams and to avoid hindering their ability to test and treat patients. If laboratory personnel were to be significantly impaired, it could become difficult for the country to continue to respond to this crisis. Providing this waiver serves to minimize the disruption to the workforce that is occurring while maintaining the best possible patient care.
Concerning the suspension of inspections, here’s what it means for you and your laboratory should your inspection fall within this timeframe:
- You will remain CAP accredited.
- To maintain quality and safety, continue proficiency testing (PT) participation.
- Continue to follow all CAP-accreditation checklist requirements.
As the situation is fluid, we will communicate with impacted laboratories regarding rescheduling inspections. Once the decision is made to resume routine CAP inspections, your laboratory will be provided with the inspection date to ensure that the inspection can occur as planned.
Concerning the postponement of CLIA inspections of accredited laboratories during this time of national emergency, we believe continuing laboratory inspections currently puts not only our inspectors but the laboratory personnel on site at risk of interlaboratory transmission of disease. This is unacceptable at a time when the nation needs our laboratory personnel to be safe. The CAP also believes it is in the nation’s interest for our laboratory personnel to focus on meeting the demands of this pandemic.
Prior to the national emergency declaration, the CAP remained engaged with officials from the HHS, CMS, Centers for Disease Control and Prevention, and Food and Drug Administration regarding laboratory testing for the coronavirus disease caused by the SARS-CoV-2 virus. The CAP has provided specific examples of regulatory changes the agencies should make in response to the pandemic. In addition, the CAP has participated in multiple calls to answer questions and request flexibility and discretion on requirements when necessary. The CAP’s advocacy has focused on issues concerning pathologists across the country during the pandemic—namely, the regulatory steps agencies can take to increase laboratory testing and patient access while also maintaining laboratory quality. Read more here.
Also, read more here for other CAP-related COVID-19 news.
Patrick Godbey, MD, FCAP
President, College of American Pathologists
Richard M. Scanlan, MD, FCAP
Chair, Council on Accreditation