F887: COVID-19 Immunization

Effective April 28, 2025, the guidance previously outlined in CMS Memo QSO-21-19-NH (released May 11, 2021) regarding COVID-19 vaccine education and offering was formally incorporated into Appendix PP of the State Operations Manual, as detailed in the recently issued QSO-25-14-NH memo.

This incorporation, specifically under F-Tag 887 (§483.80 Infection control), signifies a permanent integration of these infection control measures. While the core requirements for facilities to educate residents (or their representatives) and staff members on the benefits and potential side effects associated with the COVID-19 vaccine, and to subsequently offer the vaccine, remain consistent with the 2021 memo, their formal placement within Appendix PP underscores the ongoing and established expectation for comprehensive adherence.

LTC facilities must ensure their policies, procedures, and practices are robust and fully aligned with these formalized requirements. We urge all administrators to review the detailed guidance within F887 to ensure full preparedness and ongoing compliance.

Key Considerations for LTC Administrators

1. Robust Policies & Procedures:

   • Develop and implement written policies and procedures covering all aspects of §483.80(d)(3)(i-vii).

   • These policies must be kept current with evolving CDC, FDA, and manufacturer guidance. (Annual review recommended)

2. Comprehensive Education Program:

   • For Residents/Representatives & Staff:

     • Content: Benefits, risks, potential side effects (common and rare), multi-dose information (including any changes for additional doses).

     • Materials: Provide FDA EUA Fact Sheets (for EUA vaccines) or CDC Vaccine Information Statements (VIS) (for FDA-approved vaccines). Ensure materials are understandable.

     • Timing: Education must occur before offering the vaccine and before requesting consent for any additional doses.

   • Resources: Utilize CDC, FDA, and Immunization Action Coalition resources. Involve the Medical Director and Infection Preventionist.

3. Systematic Vaccine Offering:

   • Offer to all residents and staff when vaccine is available to the facility, unless medically contraindicated or already immunized.

   • "Staff" includes regular (at least weekly) employees, contractors (hospice, dialysis, therapists, etc.), and regular volunteers.

   • Screen for prior immunization, precautions, and contraindications.

   • Address missed opportunities: Offer vaccine ASAP to new admissions/hires, or those who previously declined but now wish to be vaccinated. If unavailable in-facility, provide information on external access and document efforts to obtain vaccine.

4. Respect for Rights & Refusal:

   • Residents/Representatives: Have the right to accept, refuse, and change their decision without coercion, discrimination, reprisal, social isolation, denied visitation, or involuntary discharge.

   • Staff: Follow state law and facility policies for staff refusal.

5. Meticulous Documentation:

   • Resident Medical Record:

     • Education provided (benefits/risks).

     • Each dose administered.

     • Reason if not vaccinated (medical contraindication or refusal).

     • Date of education/offering, name of representative (if applicable).

     • Retain samples of educational materials used.

   • Staff Records:

     • Education provided (benefits/risks).

     • Vaccine offered OR information on obtaining it.

     • COVID-19 vaccine status and related information as per CDC's NHSN.

     • Documentation of prior immunization if applicable (request from staff).

     • Roster/sign-in for education, date, samples of materials.

6. Safe Vaccine Administration & Adverse Event Management:

   • Administer per CDC, ACIP, FDA, and manufacturer guidelines, following infection control protocols.

   • Monitor for adverse reactions and have strategies for management (per F757).

   • Report specified adverse events to VAERS (Vaccine Adverse Event Reporting System).

7. Ongoing Monitoring & Improvement:

   • Track vaccination coverage.

   • Adjust communication strategies to improve understanding and uptake.

Compliance Probes for Administrators

I. Policies & Procedures:

[ ] Do we have current, written policies and procedures addressing all elements of F887 §483.80(d)(3)?

[ ] When were these policies last reviewed and updated to reflect current CDC/FDA guidance? (Probe: Is there an annual review schedule?)

II. Education:

[ ] How do we ensure all staff (including new hires and regular contractors) receive education on COVID-19 vaccine benefits, risks, and side effects before being offered?

[ ] What materials are used (EUA Fact Sheets/VIS)? Are they current?

[ ] How do we ensure all residents (or their representatives), including new admissions, receive education on COVID-19 vaccine benefits, risks, and side effects before being offered?

[ ] What materials are used? Are they current and understandable?

[ ] If multiple doses are required, how do we re-educate staff and residents/representatives on current information, including any changes in benefits/risks, before requesting consent for additional doses?

[ ] Is education provided in a manner individuals can understand?

III. Offering Vaccine:

[ ] How do we ensure every resident and staff member is offered the COVID-19 vaccine when available (unless contraindicated or already immunized)?

[ ] What is our process for offering the vaccine to new residents/staff, or those who initially refused but now want it?

[ ] If vaccine is unavailable in-facility, what information do we provide on external access, and how do we document our efforts to obtain it?

[ ] Do we screen individuals for contraindications or prior immunization before offering?

IV. Resident Rights & Refusal:

[ ] How do we ensure residents/representatives can freely accept or refuse the vaccine, and change their decision, without any negative consequences?

[ ] What are our facility policies regarding staff vaccine refusal, and do they comply with state law?

V. Documentation (This is a critical ongoing and annually auditable area):

Resident Records:

[ ] Does each resident's medical record document:

[ ] Provision of education (benefits/risks)?

[ ] Each dose administered?

[ ] If not vaccinated: medical contraindication or refusal?

[ ] Date of education/offering and representative's name (if applicable)?

[ ] Are samples of educational materials provided to residents maintained and available?

Staff Records:

[ ] Does documentation for each staff member include:

[ ] Proof of education (benefits/risks)? (e.g., sign-in sheets, date, sample materials)

[ ] Offer of vaccine or information on obtaining it?

[ ] COVID-19 vaccine status (as per NHSN requirements)?

[ ] Documentation of prior immunization if they were vaccinated elsewhere?

[ ] Is staff vaccination data being reported to NHSN as required? (Probe: Who is responsible? How often is this verified?)

VI. Vaccine Administration & Adverse Events:

[ ] Are vaccines administered according to current clinical guidelines and infection control standards?

[ ] What is our protocol for monitoring and managing post-vaccination adverse events?

[ ] How do we ensure mandatory adverse events are reported to VAERS?

VII. Continuous Improvement & Oversight (Annual Review Focus):

[ ] How frequently do we review our facility's COVID-19 vaccination rates for residents and staff?

[ ] How do we use this data to adjust our education and outreach strategies?

[ ] Is there an annual (or more frequent) internal audit process to check compliance with all aspects of F887, especially documentation?

[ ] Are the Medical Director and Infection Preventionist actively involved in overseeing the COVID-19 immunization program?

By regularly asking these questions and reviewing these considerations (with a specific formal review at least annually), LTC administrators can better ensure ongoing compliance with F887.

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