Revised Staff Vaccination Guidance

CMS Updates Guidance Related Staff COVID-19 Vaccination Requirements

CMS’s Quality, Safety & Oversight Group posted Revised Memo on October 26, 2022, which provides revised guidance and survey procedures for all provider types related to assessing and maintaining compliance with the staff vaccination regulatory requirements. (Revised Guidance for Staff Vaccination Requirements Ref: QSO-23-02-ALL)

• The revised guidance and survey procedures is for all provider types related to assessing and maintaining compliance with the staff vaccination regulatory requirements.
• This memorandum replaces memoranda QSO 22-07-ALL Revised, and QSO 22-09-ALL Revised, and QSO 22-11-ALL Revised to consolidate the information into a single memorandum.
• The guidance in this memorandum applies to all states.

CMS is replacing QSO memoranda 22-07-ALL Revised, 22-09-ALL Revised, and 22-11-ALL Revised and is revising the interpretive guidance for all provider types found in Attachments A through N in the Memo. The revisions address frequency of review of the Staff Vaccination requirements, as well as Immediate Jeopardy, Condition-level and actual harm determinations to ensure that deficiency citations recognize good faith efforts by providers/suppliers.

Staff COVID-19 vaccination requirements have not changed. CMS expects all providers’ and suppliers’ staff to have received the appropriate number of doses of the primary vaccine series unless exempted as required by law or delayed as recommended by CDC. Facility staff vaccination rates under 100% constitute noncompliance under the rule. Noncompliance does not necessarily lead to termination, and facilities will generally be given opportunities to return to compliance. For example, a facility that is noncompliant and has implemented a plan to achieve compliance would not be subject to an enforcement action.

Review of Staff Vaccination Requirements
While Federal, State agencies (SAs), Accrediting Organization (AOs), and CMS-contracted surveyors may expand any survey to include staff vaccination requirement compliance review, SAs and AOs will only be expected to perform compliance reviews of the staff vaccination requirements as part of initial certification, standard recertification or reaccreditation surveys, and in response to specific complaint allegations related to the staff vaccination requirements. Surveyors may modify the staff vaccination compliance review if the provider/supplier was determined to be in substantial compliance with this requirement within the previous six weeks. Additional information and expectations for compliance can be found at the provider-specific guidance attached to this memorandum.

REVISION – Citing Noncompliance – Level of Deficiency

The following is the revised guidance for citing non-compliance with staff vaccination requirements for hospice, home health, and home infusion therapy. Review each section of the attachment [link above] for full guidance details

• Attachment C: Hospice
• Attachment G: Home Health Agencies
• Attachment L: HIT

For instances of noncompliance identified through the survey process, the level of deficiency will be determined based on the threat posed to patient health and safety. Situations indicating egregious noncompliance, such as a complete disregard for the requirements, should be cited at the condition level. Examples of egregious noncompliance could include more than 50% of staff being unvaccinated (unless exempted, or temporarily delayed), and/or policies and procedures have not been implemented as required. When there are egregious cases of noncompliance, state survey agencies should notify the CMS location of the information. Examples of when noncompliance should be cited at the standard level could include less than 50% of staff being unvaccinated and/or 1 or more of the policies and procedures have not been implemented as required, but good faith efforts are being made toward compliance with the staff vaccine requirements.

NOTE: Regardless of a facility’s compliance with the staff vaccination requirements, surveyors should closely investigate infection prevention and control practices to ensure proper practices are in use, such as proper use of personal protective equipment, transmission precautions which reflect current standards of practice, and/or other relevant infection prevention and control practices that are designed to minimize transmission of COVID-19.