On August 26, 2020, the Centers for Medicare and Medicaid Services (CMS) issued a memorandum, QS0-20-37-CLIA, to announce updates to the Clinical Laboratory Improvement Amendments (CLIA) that are defined in the interim final rule CMS-3410-IFC. The rule imposes new requirements on laboratories for reporting SARS-CoV-2 test results during the public health emergency.
This alert provides a summary of the changes and impact on laboratories. The CAP strongly recommends that laboratories review the memorandum and interim final rule for more details. The CMS published the interim final rule in the Federal Register on September 2, 2020, and laboratories must be compliant with the new reporting requirements by September 23, 2020.
The CLIA regulations now include:
- Requirements for reporting all results of tests intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 to local or state health authorities in a standardized format and at a frequency specified by the Secretary of Health and Human Services (HHS) (42CFR493.41 and 42CFR493.1100).
- Provisions for sanctions and civil money penalties for non-compliance with COVID-19 result reporting requirements (42CFR493.1804 and 42CFR493.1834).
What does this change mean for my laboratory?
- All positive and negative SARS-CoV-2 (COVID-19) test results must be reported to your local or state health authority, including:
- All molecular, antigen, and antibody (serology) test methods
- Testing performed by laboratories with all CLIA certificate types (Certificate of Accreditation, Compliance, Register or Waiver, and Provider-Performed Microscopy).
- The CLIA regulations for SAR-CoV-2 (COVID-19) result reporting do not apply if your laboratory only collects and refers specimens to another laboratory for testing.
- Your laboratory is considered in compliance with reporting to HHS if you submit the results to the local or state health authorities.
- Failure to comply with the new CLIA regulations may result in sanctions and civil monetary penalties.
Is my laboratory required to submit SARS-CoV-2 (COVID-19) test results following the June 4, 2020 HHS laboratory data reporting guidance that defines specific required data elements and timelines for reporting ?
- The updated CLIA regulations and CMS enforcement do not address all provisions described in the HHS guideline (such as the inclusion of all 18 data elements, ask on order entry questions, or reporting of the results within 24 hours).
- Your laboratory should work with your state or local health authority on reporting results following the HHS guidance. Refer to the CDC resource How to Report COVID-19 Laboratory Data for more information on reporting.
- The reporting requirement does not apply to surveillance testing (used to gain information about infection at a community or population level, rather than an individual level) in which patient-specific results are not reported.
What actions will the CAP take if it identifies noncompliance with SARS-CoV-2 (COVID-19) result reporting at a laboratory?
As your accrediting organization, the CAP is required to notify the CMS if noncompliance with the CLIA regulations is identified. Noncompliance may be identified through:
- A CAP inspection
- A complaint investigation
- Other means as mandated by CMS
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