The Department of Health and Human Services (HHS) declared the end of the federal Public Health Emergency (PHE) for COVID-19 on May 11, 2023. The Center for Clinical Standards and Quality/Quality, Safety & Oversight Group (QSOG) has since released a memorandum (QSO-23-15-CLIA) with updates to CLIA requirements now that the PHE has ended.
According to the memorandum, “During the PHE, CMS did not enforce certain CLIA regulations, provided that laboratories followed the specific parameters outlined in CLIA PHE guidance. CMS also relaxed or changed policies and procedures to provide more flexibility within the CLIA regulations and highlighted flexibilities that already existed. The exercise of some of these enforcement discretions and broad flexibilities will be terminated by the end of the PHE, as they were intended to address the acute and extraordinary circumstances of a rapidly evolving pandemic and not replace existing requirements.”
Now, these COVID-era regulations have been updated once again to reflect the end of the PHE. Below are a few commonly asked questions regarding the QSOG memorandum, and how these changes may affect your organization.
- Does my laboratory still need to report my SARS-CoV-2 test results?
No, CMS no longer requires laboratories to report their SARS-CoV-2 test results after the end of the PHE, but your laboratory may still need to report your results due to state reporting requirements. Please contact your state prior to discontinuing reporting the test results.
- Am I still allowed to review digital data, results, and images at home?
Pathologist and other laboratory personnel will still be allowed to review digital data, results, and images remotely without a separate CLIA certificate as long as they meet the criteria set within memo QSO-23-15-CLIA.
- Am I still allowed to review physical slides at home?
No, CMS will not allow for physical slides to be reviewed remotely.
- Is CMS expediting CLIA certificate application reviews still?
No, CMS has determined that they will no longer expedite reviews for CLIA certificate applications for laboratories that are performing COVID-19 testing. Laboratories must obtain their CLIA number or certificate prior to testing.
- Will I still be allowed to use molecular and antigen point of care tests for asymptomatic testing?
No, all CLIA-certified laboratories must follow the manufacturer’s instructions for use for SARS-CoV-2 testing.
- Will CMS still allow for alternative specimen collection devices?
CMS will be returning to the pre-public health emergency requirements in which laboratories must follow the test manufacturer’s instructions. If the test manufacturer’s instructions do not include instructions for using alternate specimen collection devices or media, the laboratory must establish test performance specifications.
- If my laboratory has expired reagents, would we be able to still use them?
No, CMS is returning to pre-public health emergency regulatory requirements for use of expired reagents. Laboratories cannot use expired reagents. If a laboratory uses expired reagents, the test would be considered modified and high complexity.
- My laboratory is only doing surveillance testing, and we currently do not have a CLIA certificate. Do we need to have one now that the public health emergency has ended?
All laboratories performing surveillance and genetic variant testing that reports patient-specific results are required to have a CLIA certificate.