Acute Care Hospitals
Critical Access Hospitals
Clinical Laboratories

Please share this with individuals in the following roles:
Chief Nursing Officer
Accreditation Coordinator
Infection Control Program Leader
Quality Director
Medical Director – Laboratory Services

Key points: On August 25, 2020, CMS announced regulatory changes. The changes were published in the Federal Register on September 2, 2020. This interim final rule with comment period (IFC) revises regulations to strengthen CMS’ ability to enforce compliance with Medicare and Medicaid requirements for reporting information related to coronavirus disease 2019 (COVID-19).  This interim final rule establishes new requirements in the hospital and critical access hospital (CAH) Conditions of Participation (CoPs) and establishes requirements for all CLIA laboratories to report COVID-19 test results to the Secretary of Health and Human Services (Secretary) during the Public Health Emergency (PHE). These new rules represent efforts to track and control the spread of the coronavirus. Please be aware, failure to report may result in civil monetary penalties.

  • Hospitals and critical access hospitals must provide daily data reporting to HHS, including available ICU beds, ventilators, and PPE.
  • All laboratories must report COVID-19 testing and patient-specific results on a daily basis.

Are any HFAP Standards affected? HFAP is evaluating the need to update the following standards or their Required Elements.

  • Acute Care Hospital standard 07.00.03
  • Critical Access Hospitals standard 18.00.03
  • Laboratory Accreditation Requirements -TBD.

Comments to CMS are due: November 2, 2020

Effective date: September 2, 2020

Read the entire Federal Register notice announcement here.

Read the related QSO memo here.

Questions? Reach out to