CMS Revises Guidance for the Interim Final Rule – COVID-19 Health Care Staff Vaccination

Mary Madison, RN, RAC-CT, CDP
Clinical Consultant – Briggs Healthcare

On Tuesday, April 5, 2022, CMS posted revised guidance for COVID-19 HC Staff Vaccination for all providers participating in Medicare and Medicaid programs. Just as it did late in 2021 and early 2022, in response to the 2 multi-state lawsuits and the 3rd challenge from the state of Texas, CMS has updated and revised the original IFRs:

As with previous updates, there are attachments for specific providers to all 3 QSOs:

“This attachment is a supplement to and should be used in conjunction with the following memoranda: QSO-22-07-ALL-Revised, QSO-22-09-ALL-Revised, and QSO 22-11-ALL-Revised memorandum: Guidance for the Interim Final Rule – Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination. While the memoranda noted above apply to specific states, the regulations and guidance described in this attachment apply to all states. Implementation of this guidance will occur according to the timeframes and parameters identified in either QSO-22-07-ALL-Revised effective December 28, 2021, QSO-22-09-ALL- Revised effective January 14, 2022, or QSO-22-11-ALL-Revised effective January 20, 2022.”

The red ink (revisions) in all 3 of the main QSO Memorandums is found here:

When you review the attachment that applies to you as a provider, you find more red ink. For this blog, I’ll highlight what’s changed (italicized below) for LTC facilities (14-pages).

  • Updated definition of Temporarily delayed vaccination
  • New NOTE: Facility staff who have been suspended or are on extended leave e.g., Family and Medical Leave Act (FMLA) leave, or Worker’s Compensation Leave, would not count as unvaccinated staff for determining compliance with this requirement.
  • Applicable has been added in front of memorandum for each of the 30, 60 and 90-day implementation timeframes
  • Another new NOTE: This requirement is not explicit and does not specify which actions must be taken. The examples above are not all inclusive and represent actions that can be implemented. However, facilities can choose other precautions that align with the intent of the regulation which is intended to “mitigate the transmission and spread of COVID-19 for all staff who are not fully vaccinated.”
  • Facilities must have a process to track and secure documentation of the vaccine status of staff whose vaccine is temporarily delayed. CDC recommends a temporary delay in administering the COVID-19 vaccination due to clinical considerations, including known COVID-19 infection until recovery from the acute illness (if symptoms were present) and criteria to discontinue isolation have been met.
  • Survey Process Updates for tag F888: To determine compliance with §483.80(i), surveyors will request the facility’s COVID-19 vaccination policies and procedures, the number of resident and staff COVID-19 cases over the last 4 weeks, a list of all staff (see note below regarding sampling contracted staff), their vaccination status, and information on how the facility ensures that their contracted staff are compliant with the vaccination requirement. The staff list must include the position or role of each staff member, including staff (facility staff, volunteers, or students) who are or are likely to be in contact with residents or other staff, regardless of frequency. NOTE: The list of vaccinated staff maintained by the facility, or the Staff Vaccine Matrix are used for sampling staff. Please refer to Long-Term Care Survey Process Procedure Guide and/or CMS 20054, Infection Prevention, Control & Immunization for instructions for sampling contracted staff.

CMS will update the CMS-20054: “Infection Prevention, Control & Immunizations” Facility Task to include the new requirement at F888 for staff COVID-19 vaccination. Additionally, CMS will update associated survey documents, which will be found under the “Survey Resources” link in the Downloads Section of the CMS Nursing Homes website. The updated documents will also be added to the Long-Term Care Survey Process software application. Surveyors will review for compliance with this requirement on all initial certification, standard recertification surveys, as well as all complaint surveys. Surveyors may modify the staff vaccination compliance review if the facility was determined to be in substantial compliance with this requirement within the previous six weeks. For Life Safety Code (LSC)-only complaint or LSC-only follow-up surveys, staff vaccination requirements are not required to be investigated.

  • Another new NOTE: Failure of contract staff to provide evidence of vaccination status reflects noncompliance and should be cited at F888 under the requirement to have policies and procedures for ensuring that all staff are fully vaccinated, except for those staff who have been granted exemptions or a temporary delay at 483.80(i)(3)(ii).
  • Level 2: No actual harm w/potential for more than minimal harm that is not IJ
    • Did not meet the requirement of staff vaccinated; and
    • No resident infections
  • Surveyors and CMS may lower the scope and severity of a citation and/or enforcement action if they identify that any of the following have occurred prior to the survey (note: noncompliance is still cited, only the scope, severity, and/or enforcement is adjusted). a) If the facility has no or has limited access to the vaccine, and the facility has documented attempts to obtain vaccine access (e.g., contact with health department and pharmacies). b) If the facility provides evidence that they have taken aggressive steps to have all staff vaccinated, such as advertising for new staff, hosting vaccine clinics, etc. For example, if the facility staff vaccination rate is 90% or more, there is no resident outbreak in the previous 4 weeks, and all policies and procedures were developed and implemented, per Table 1 this would be cited “D”. However, if the facility provides evidence that it has made a good faith effort by taking aggressive steps to get all staff vaccinated, surveyors may lower the citation to “A”.

Lastly, the Scope and Severity Grid has been updated – note the red, italicized verbiage in Levels 2 and 4.

Please review the QSO and the attachment that pertains to your facility, agency, etc. with your team.

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