Public Health Emergency Updates for CAP Customers

With the U.S. COVID public health emergency (PHE) expiring on May 11, 2023, the CAP is transitioning its inspection date notification process for laboratories located in the U.S. and Canada.

All CAP-accredited laboratories affiliated with an institution accredited by The Joint Commission will be notified one hour prior to inspection, per the CAP’s current collaborative agreement with The Joint Commission. All other CAP-accredited laboratories subject to CLIA regulations will be notified two weeks prior to their scheduled inspections.

Note: if your laboratory has already been notified of its inspection date, there will be no anticipated change to that date.

International Laboratories and Laboratories in the FDT, BAP, and RLAP Programs

For international laboratories as well as any facilities accredited through the CAP’s Forensic Drug Testing, Biorepository, and Reproductive Laboratory Accreditation Programs, the inspection date notification process will not change; these laboratories and facilities will continue with their current inspection date notification process after the U.S. PHE expiration.

Initial Inspections for New Laboratories

Laboratories undergoing their first inspection with a CAP Accreditation Program (who are not joining a group that is already accredited by CAP), will receive confirmation of the inspection date once it is scheduled.

Patient Care Areas

As of May 12, 2023, CAP accreditation inspectors can resume visits to facility patient care areas. If a facility is allowing visitors in patient care areas during the time of an accreditation inspection, inspectors should also be allowed in those areas.

However, if a facility is restricting visitors within the institution for any reason, the CAP recommends that inspectors comply with the facility’s visitor policies at the time of the inspection. If inspectors are not allowed in patient care areas, they should alternatively interview relevant staff to address the necessary checklist items.

If you have questions or concerns, please contact the CAP at 800-323-4040 or accred@cap.org.

Post-Public Health Emergency Result Reporting and Remote Review Changes

On May 11, 2023, the Centers for Medicare and Medicaid Services (CMS) issued memorandum QSO-23-15-CLIA , discontinuing the post-Public Health Emergency (PHE) reporting of SARS-CoV-2 test results to the state and public health authorities and clarifying the continued enforcement discretion for remote review of digital images, data, and reports. Read More

FDA Guidance Summary: Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)

Guidance summary: The guidance outlines the FDA's transition plan for medical devices issues emergency use authorization related to coronavirus disease 2019 (COVID-19). The FDA developed this guidance to describe a transition plan for the termination of the EUA declaration and the process for such termination for all devices issued an EUA for SARS-CoV-2 testing including laboratory-developed tests (LDTs). Moreover, the FDA is required to provide advance notice that an EUA declaration will be terminated and to publish such notice in the Federal Register. When an EUA declaration is terminated, all EUAs issued under that declaration also terminate. After an EUA declaration terminates, it ceases to be in effect and the emergency use of all products under the EUA declaration is no longer authorized.

Impact on clinical laboratories: The March 2023 EUA guidance applies to all clinical laboratory diagnostic tests including LDTs. Clinical laboratories are allowed to continue using the EUA authorized device while it is under FDA review. Manufacturers are required to have a plan to communicate these changes to clinical laboratories, but the FDA will review the information available publicly. The FDA will also classify EUA devices as part of this regulatory review. For devices no longer available for distribution, the FDA will allow these clinical tests to remain on the market if the device is (1) restored to an FDA-cleared or approved version or (2) an electronic copy of the updated labeling accurately describes the product features and regulatory status (eg, the product lacks FDA clearance, approval, or authorization). For EUA LDTs, the FDA intends to exercise enforcement discretion as it does with other LDTs.

FDA Guidance Summary: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

Guidance Summary: The guidance outlines the transition plan for medical devices falling within the enforcement policies during the coronavirus disease (COVID-19) public health emergency (PHE). By November 7th, the FDA will no longer allow for distribution of medical devices used during the PHE unless they are currently under FDA regulatory review, or the manufacturers intend to stop distribution of a device. Manufacturers are responsible for developing a plan to communicate any changes to the device's regulatory status in addition to the FDA making this information publicly available. If a device is no longer distributed by the manufacturer, the FDA will allow it to remain on the market if the manufacturer updates the device's label and continues adverse event reporting.

Impact on clinical laboratories: The March 2023 transition plan for medical devices under the enforcement policy applies to digital pathology devices that were used in remote reviewing and reporting of digital pathology slides. The enforcement policy entitled, Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency allowed for the use of digital pathology devices such as automated digital image manual interpretation microscopes, whole slide imaging systems, digital pathology image viewing and management software, and digital pathology displays. Therefore, clinical laboratories can continue using these devices before August 2023 if the device is (1) restored to an FDA-cleared or approved version or (2) an electronic copy of the updated labeling accurately describes the product features and regulatory status (eg, the product lacks FDA clearance, approval or authorization).