Post-Public Health Emergency Result Reporting and Remote Review Changes

Communication Date: June 2, 2023

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

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.

SARS-CoV-2 Test Result Reporting Requirements

The requirement to report all SARS-CoV-2 test results ended with the expiration of the PHE . However, laboratories must still comply with state and local regulations and should verify the current guidance for the reporting of SARS-CoV-2 test results to their state and local public health authorities.

Checklist requirement GEN.41316 (Infectious Disease Reporting) will be revised to reflect the change to the federal mandate.

Remote Staff Performing Review of Digital Clinical Laboratory Data, Digital Results, and Digital Images

The enforcement discretion continues to allow pathologists and laboratory personnel to perform remote review of digital data, digital results, and digital images accessed by VPN (or other secured network), under the main laboratory’s CLIA certificate, provided the laboratory meets the criteria in memorandum QSO-23-15-CLIA. The test report must include the remote site location where the testing was performed, although a coding system (eg, site ABC) may be used in lieu of a personal address.

The CMS enforcement discretion does not extend to the remote review of glass slides. CMS’s rationale is that, “…a microscope and other laboratory equipment is necessary to perform the testing. The necessity of such equipment is a hallmark of a separate laboratory… Therefore, after the PHE has terminated, CMS will not continue to exercise its enforcement discretion for the review of physical slides.” If laboratories choose to continue to perform the review of glass slides remotely on a routine basis, they will need to obtain a CLIA certificate.

For more information, read the COVID-19 Questions and Answers on the CAP website or email accred@cap.org.