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GEN.41316 Update for Inspectors and CAP-Accredited Laboratories

This alert serves as notification that an amendment has been made to the Laboratory General Checklist (GEN) requirement, GEN.41316 (Infectious Disease Testing) for the reporting of SARS-CoV-2 (COVID-19) test results that is effective immediately for all laboratories subject to US regulations.

The change aligns with new Clinical Laboratory Improvement Amendments (CLIA) regulations, QS0-20-37-CLIA, published in the Federal Register interim final rule and supports the national public health response to the COVID-19 pandemic. Please review the September 2020 CAP eAlert for more information on the regulation.

Checklist Revision

GEN.41316 Infectious Disease Reporting Phase II

There is a policy regarding the timely communication, and documentation thereof, of diagnoses of infectious diseases of particular significance (eg, human immunodeficiency virus, COVID-19*, and tuberculosis).

NOTE: The laboratory should have a policy to ensure that diagnoses of human immunodeficiency virus infection and other serious infections (for example, tuberculosis or COVID-19) are communicated to the responsible clinician in a timely manner. The intent of this checklist item is NOT to require that these diagnoses be treated as critical results (this decision is up to the laboratory director); rather, the intent is that the laboratory assures that its reporting system is effective.

*Effective September 2, 2020, laboratories subject to US regulations performing testing intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 must report positive and negative results to local or state health authorities in a standardized format and at a frequency specified by the Secretary of Health and Human Services (HHS) to include all molecular, antigen, and antibody test methods used in laboratories with all types of CLIA certificates. This requirement applies to COVID-19 tests of all levels of complexity (including waived). Laboratories not in compliance by September 23, 2020 may be subject to sanctions and civil money penalties from the Centers for Medicare and Medicaid Services. This requirement also applies to the Department of Defense and Veterans Affairs laboratories for testing performed in the United States and its territories. The reporting requirement does not apply to surveillance testing (used to gain information at a community or population level, rather than an individual level) where patient-specific test results are not reported.

The checklist revisions are now included in checklists sent by the CAP or downloaded from cap.org behind e-Lab Solutions Suite for the 2018, 2019 and 2020 Checklists. If your laboratory was sent a previous version of the Checklist to prepare for your on-site or self-inspection, or you downloaded previous versions of the Checklist, you must comply with the GEN.41316 revision, regardless of when your laboratory is due to be inspected.

The revised requirement is being sent to all inspection teams assigned to perform inspections of laboratories that perform testing for COVID-19. Inspection team leaders that have already been sent inspection materials will be receiving an email notification to download updated inspection materials.

Who needs to be aware of these changes?

  • All CAP-accredited laboratories subject to US regulations performing testing intended to detect COVID-19 or diagnose a possible case of COVID-19 by all methods, all levels of complexity (including waived), and all CLIA certificate types
  • CAP inspectors performing inspections of laboratories subject to US regulations that perform this testing.

What actions does my laboratory need to take?

  • Work with your local or 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 local or state health authority

What actions do inspectors need to take?

  • Ensure that the inspection team members inspecting infectious disease testing and using the GEN Checklist are aware of this revision
  • Ask laboratories to explain their process for reporting COVID-19 results to local or state health authorities and perform an audit of their reporting records to ensure that required results are consistently reported
  • 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)
  • COVID-19 Information on the status of CAP inspections
  • September 2020 Mandatory Test Result Reporting for SARS-CoV-2(COVID-19) eAlert

The following resources are available for your reference:

  • COVID-19 Information on the status of CAP inspections
  • September 2020 Mandatory Test Result Reporting for SARS-CoV-2(COVID-19) eAlert

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