A recent record check by the Centers for Medicare & Medicaid Services (CMS) resulted in 171 cease and desist letters to facilities across the US conducting COVID-19 testing without proper, up-to-date Clinical Laboratory Improvement Amendments of 1988 (CLIA) certifications. CMS believes that CLIA certification is extremely important because it validates that laboratories are meeting the required federal compliance regulations regarding quality and safety standards needed to accurately diagnose, prevent, and treat diseases.
CMS considers that every facility performing COVID-19 testing is deemed a “laboratory” and is required to have CLIA certification. Consequently, at the onset of the public health emergency brought about with the Coronavirus crisis, CMS implemented an expedited review process, including the release of a quick start guide to help with the application process. Facilities are required to apply for CLIA certification and operate strictly within the scope of that certification to prevent false results that could adversely alter diagnosis and treatment, and contribute to the further spread of COVID-19.
The cease and desist letters sent to non-CLIA certified facilities included information on how to become CLIA certified and advised those facility laboratories to obtain the proper CLIA certification to resume testing.
Compliance Perspective
Issue
Failure by a facility to have up-to-date CLIA certification may result in inaccurate testing results that can impede the proper care needed by residents. Because of the cohorting required for residents receiving positive test results, a false positive COVID-19 test could place that resident in jeopardy for harm, which could be considered provision of substandard quality of care. Likewise, a false negative result could place others at risk for harm by spreading the infection.
Discussion Points
- Review policies and procedures for obtaining and renewing CLIA certification to ensure they are current.
- Train staff involved in the process for contracting with vendors to ensure that all external laboratories used by the facility are CLIA certified. Ensure staff are knowledgeable about which specific tests can be performed internally under the facility’s CLIA certificate.
- Audit to determine that the facility’s CLIA certification is current, and monitor for compliance with the renewal process.
