Attention: Clinical Laboratories

Please share this information with individuals in the following roles:

Accreditation Coordinator
Quality Director
Medical Director – Laboratory

Key points:

  1. ALL laboratories regardless of CLIA type (including those with a Certificate of Waiver and Point of Care testing) must report both positive and negative results to their state or local public health department for all SARS-CoV-2 testing performed:
    for each individual tested.
    within 24 hours of test results being known or determined.
    on a daily basis.
    to the appropriate state or local public health department based on the individual residence.
    This reporting is for the duration of the PHE.
  2. CMS will impose Civil Monetary Penalty for laboratories that fail to comply.
  3. Failure of a laboratory to comply will result in a condition level violation of CLIA.
  4. CFR 493.41 and CFR 493.1100 have been revised to reflect these requirements.
  5. HFAP will have to notify CMS within 10 days after identifying a laboratory that fails to report SARS-CoV-2 results.
  6. HFAP will have to notify CMS every 10 days of those labs failing to report.

Laboratories that collect test specimens to send to external testing laboratories do not need to report results.

Are any HFAP Standards affected? HFAP is evaluating the need for a new standard.

Effective date: August 26, 2020

Read the entire memo/announcement/document here. https://www.cms.gov/files/document/qso-20-37-clianh.pdf

Questions? Please contact info@hfap.org.