The Centers for Medicare & Medicaid Services (CMS) will allow clinical laboratory personnel to continue reviewing digital materials remotely, while prohibiting the remote review of physical slides, according to updated guidance issued May 11 regarding the application of Clinical Laboratory Improvement Amendments (CLIA) following the end of the COVID-19 public health emergency (PHE).
During the PHE, CMS exercised enforcement discretion with certain CLIA regulatory requirements. While CMS has determined that it will no longer excuse noncompliance with some provisions, the memorandum provides guidance on regulatory flexibilities that will remain in place.
Pathologists and other laboratory personnel will continue to be permitted to review digital laboratory data, digital results, and digital images remotely. A separate CLIA certificate for the remote testing site will not be necessary if the work performed at the remote testing site is consistent with the specialties under the CLIA certificate held by the primary testing site.
The remote testing site can act as “an extension of the laboratory” when secure methods of digital access are used and no physical laboratory equipment is required. Reviewing physical slides requires the use of a microscope and other laboratory equipment and is therefore not included within this enforcement discretion, as the use of this equipment would create a separate laboratory in need of its own CLIA certificate.
Laboratories choosing to allow staff to remotely review digital clinical laboratory data may only do so if they meet several criteria, including: compliance with applicable federal laws, including HIPAA; inclusion of the remote testing site’s location on test reports; retention of all documentation, including tests performed by remote staff; and the presence of the remote reviewer on the primary testing site’s Form CMS-209, Laboratory Personnel Report.
Secure or digital electronic signatures are acceptable and should include an electronic date and time stamp. The laboratory should show evidence that those individuals utilizing the electronic signature are authorized to do so.
In accordance with pre-PHE requirements, expedited review of CLIA applications will no longer be honored, and laboratories may only begin testing if they have paid applicable laboratory fees and have obtained a CLIA certificate.