A Must Read: Comprehensive COVID Regulatory Checklist

4 minutes

Warning – the devil is in the details

You may find the resource links below helpful as you wade through the hundreds of hospital-related requirements and truly understand all the nuances of the various requirement sets.

We will keep you updated as things emerge, such as legal challenges, CMS interpretive guidelines or accreditation requirements.

Helpful links


1. Vaccinations for Hospital Associates (November 2021)

Status of the requirement:

The CMS rule is currently in effect.
  • The OSHA rule does not apply to healthcare entities covered by the CMS rule.
  • Implementation of the OSHA vaccination and testing rule is on hold due to court challenges.
  • Although the CMS rules are also facing court challenges from 10 states, implementation has not been delayed. Update: On December 2, 2021, CMS put a hold on implementation of the new rule due to a court order in (See CMS Memo to State Agency Directors QSO-22-04-ALL). It is uncertain how long the stay in implementation will remain in effect. Stay tuned.
Expected soon:
  • CMS interpretive guidelines
  • Updates to standards adopted by The Joint Commission and other accreditors with CMS deeming authority

Vaccination is now required for most hospital associates, including employees, members of the medical staff, students, trainees, volunteers, and contractors.

Testing in lieu of vaccination is not allowed.

Exceptions from and delays in vaccination are allowed for

  • Valid clinical contraindications and
  • Faith-based refusals

Important dates:

November 5, 2021
  • The rule became effective.
  • Enforcement began by the State Survey Agencies during routine and for-cause surveys as a standard under the Infection Prevention and Antibiotic Stewardship Condition of Participation.
  • Noncompliance will likely lead to the threat of termination from the Medicare/Medicaid program.
  • The hospital is expected to have adopted a process (typically expressed in the form of a policy) for
    • Tracking and enforcing required vaccinations,
    • Approving exemptions from and delays in vaccination, and
    • Mitigating precautions taken when associates are not “fully vaccinated.”
  • Booster vaccination doses are not required, but they must be “tracked” by the hospital.
December 6, 2021

All non-exempt, covered associates performing hospital duties must have received the first dose in their “primary vaccination series.” The date for primary vaccinations to be completed for employee/associates will be delayed until the court-order stay in enforcement is lifted (QSO-22-04-ALL).

January 4, 2021

All non-exempt, covered associates performing hospital duties must have completed their “primary vaccination series.”

  • There are many options for completing the primary vaccination series, including non-FDA-approved vaccines, participation in clinical trials, and a series with mixed-vaccines.
  • Non-exempt, covered associates need not complete the 14-day period after the last dose in their primary vaccination series before initiating hospital duties.

2. OSHA COVID-19 Plan (June 2021)

Healthcare employers must adopt and implement a COVID-19 plan. The OSHA-required COVID-19 plan must address:

  • patient screening and management,
  • standard and transmission-based precautions,
  • personal protective equipment (facemasks, respirators),
  • controls for aerosol-generating procedures,
  • physical distancing of at least six feet when feasible,
  • physical barriers,
  • cleaning and disinfection,
  • ventilation,
  • health screening and medical management,
  • training,
  • anti-retaliation,
  • recordkeeping,
  • reporting, and
  • paid leave for vaccinations and side effects.

The OSHA COVID-19 plan is not required for

  • non-hospital ambulatory care settings where all non-employees are screened prior to entry and people with suspected or confirmed COVID-19 are prohibited from entry,
  • well-defined hospital ambulatory care settings where all employees are fully vaccinated and individuals with possible COVID-19 are prohibited from entry, and
  • home health care settings where all employees are fully vaccinated and there is no reasonable expectation that individuals with COVID-19 will be present.

3. Data Reporting Requirements (May 2020 through May 2021)

Hospitals must continue to report COVID-related data required by CMS in the May 2020, August 2020, and May 2021 emergency reporting requirements.

4. 1135 Waivers (March 2020)

“Blanket” and facility-specific waivers under Section 1135 of the Social Security Act remain available to hospitals.

  • Blanket 1135 waivers will not be available once the President and the Director of Health and Human Services rescind the declaration of a national COVID emergency.

However, to take advantage of these 1135 waivers the hospital must

  • Be in a state where the COVID emergency declaration has not be rescinded, and
  • Be functioning under its Emergency Management plan.

© 2023 Chartis Clinical Quality Solutions. All rights reserved. This content draws on the research and experience of Chartis consultants and other sources. It is for general information purposes only and should not be used as a substitute for consultation with professional advisors. It does not constitute legal advice.

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