COVID-19 Reporting Guidelines Updated

Communication Date: April 25, 2022

NOTE: The information below was current at the time of communication. Subsequent CAP changes, if applicable, are not reflected in this eAlert.

The CAP has modified its requirements for reporting COVID-19 test results to state and local health authorities in compliance with the recent guideline changes announced by the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS). This update replaces the blanket requirement to report all SARS-CoV-2 (COVID-19) test results to state and local health authorities with a more tailored reporting approach that is specific to the laboratory type and testing performed.

What are the updated reporting requirements?

Effective April 4, 2022 laboratories subject to US regulations are required to report SARS-CoV-2 (COVID-19) test results to state and local health authorities based on the type and complexity of testing performed, as outlined in the following table:

* W=Waived; M=Moderate Complexity; H=High Complexity

If state or local health authorities have more stringent reporting requirements, they must be followed.

NOTE: The reporting requirement does not apply to surveillance testing where patient-specific test results are not reported, such as testing used to gain information at a community or population level rather than an individual level. Laboratories performing viral genomic sequencing should review guidance posted on the CDC website regarding the reporting of those results.

Will the CAP Checklist be revised to reflect these changes?

Yes, the CAP has amended the Laboratory General Checklist (GEN) requirement, GEN.41316 (Infectious Disease Testing) for the reporting of SARS-CoV-2 (COVID-19) test results in the 2020 and 2021 Checklist editions to reflect the updated guidance. You can download an updated version of the checklist by logging into e-LAB Solutions Suite on cap.org.

What actions does my laboratory need to take?

• Work with your state or local public health authorities to ensure that all required COVID-19 testing results are being reported

• Have records available (electronic or paper) to show that the required test results are being reported to your state or local health authority

What actions do inspectors need to take?

• Ask laboratories to explain their process for reporting COVID-19 results to state or local health authorities and perform an audit of their reporting records to ensure that results are consistently reported where required
• Cite GEN.41316 if non-compliance with the reporting requirement is discovered and include detailed comments on the inspection summary report (ISR) to define the scope and frequency of occurrence (eg, dates involved, test performed, types of results not reported, patient ID or accession numbers)

Where can I get more information?

The following resources are available for your reference:

• HHS reporting guidance: COVID-19 Pandemic Response, Laboratory Data Reporting: CARES Act Section 18115
• CMS memorandum: QSO-21-10-CLIA
• CDC online resource: How to Report COVID-19 Laboratory Data
• CAP online resource: CAP Responds to Your COVID-19 Questions

Questions? Contact us at 800-323-4040 or accred@cap.org.