Ftag of the Week – F887 COVID-19 Immunization

If providers thought that COVID-19-related compliance requirements were dwindling, the newly issued Interim Final Rule – COVID-19 Vaccine Immunization Requirements for Residents and Staff that was released in a May 11, 2021 QSO Memo (Ref: QSO-21-19-NH) shows us otherwise. In our last “Ftag of the Week” post, we started to work through the regulatory requirements for F604 Right to Free from Physical Restraints, but this week, we are taking a little detour to a brand-new Ftag, F887 COVID-19 Immunization. This new regulatory requirement is part of the ever-growing Infection Control regulatory group, which was expanded during the COVID-19 Public Health Emergency (PHE) to include F884, F885 and F886.

F887 COVID-19 Immunization Overview

The crux of this regulation Is the requirement that nursing homes develop and implement policies and procedures that ensure that staff, residents and representatives receive education about the COVID-19 vaccine and that vaccines are offered to all who choose to be immunized. Per this regulation, “staff” is considered anyone who works in the facility on a “regular” basis, which is defined as at least once per week, and includes contract/agency staff.

The regulatory requirements include sections for education, offering the vaccination, administering the vaccination, adverse event reporting, refusals and documentation requirements. Let’s look at each of these as well as what to expect on survey.

Offering the Vaccine

F887 requires providers to offer all residents and staff a COVID-19 vaccine when vaccine supplies are available in the facility. The regulation allows the facility to offer and provide the vaccine either directly at the facility or indirectly through another arrangement.

Facilities are required to screen residents and staff to ensure they are appropriate candidates before offering the vaccination to determine:

• Prior immunization
• Medical precautions
• Contraindications

What About Someone Who Requests a Vaccination After Missing an Earlier Opportunity?

• If a staff member or resident missed the opportunity to receive the COVID-19 vaccine, even if he/ she initially refused the vaccine, the facility is expected to offer the vaccine as soon as possible if that person has changed his/ her mind.
• If the vaccine is unavailable in the facility, the provider is required to give information to the individual about receiving the vaccination at another location. This information may be requested by a surveyor, so the facility is required to be able to provide evidence that it made efforts to make the vaccine available to staff/residents.

Do We Have to Offer Everyone the Vaccine?

The IFC notes that providers are not required to provide education to or offer the COVID-19 vaccine to individuals who are entering the facility for a limited amount of time with a specific purpose, such as a delivery person or a volunteer who is at the facility less than once a week. That said, CMS notes that the facility can do this if it wishes to.

Education

Before being offered the vaccine, all staff, residents/ representatives, as necessary, must be educated about the COVID-19 vaccine that they are being offered in a manner that they can understand. The FDA COVID-19 Emergency Use Authorization Fact Sheet must be provided to them as well. The education must address the benefits of the vaccination, the risks, and the potential side effects.

If the vaccine that will be offered is a multi-dose vaccine, the individual needs to be provided with current information about receiving additional doses, including any changes to the benefits, risk and potential side effects, before the provider can request consent to administer additional doses of the vaccine.

Administering the Vaccine

• Vaccination must be conducted in accordance with CDC, ACIP, FDA and manufacturer guidelines.
• When preparing and administering the vaccine, the facility must follow current infection prevention and control recommendations. 
• Facilities must have strategies in place to evaluate and manage post-vaccination adverse reactions, including the safety monitoring required by the vaccine EUAs.

Adverse Event Reporting

The FDA requires that select COVID-19 vaccine associated information is reported to the Vaccine Adverse Event Reporting System (VAERS). These include:

• Vaccine administration errors
• Serious adverse events
• Multisystem inflammatory syndrome
• Cases of COVID-19 that result in hospitalization or death

Refusals

Residents and/or their representatives have the right to refuse the vaccine. The facility is prohibited from taking any adverse action against a resident/ representative who has refused, including involuntary discharge, denying visitation and/or social isolation. Pay close attention to these last two areas since denying a resident the ability to have visitors or do things like participate in activities or communal dining would be violations of their rights that should be avoided.

Documentation

While this will not likely be a surprise to anyone reading this, CMS expects a lot of documentation to be in place related to the vaccine, whether it is for staff or residents. Tracking this information is so important to the Agency that it has even expanded the reporting requirement for COVID-19 data to the CDC NHSN. (We’ll look at those expanded requirements when we re-visit F884 Reporting- National Health Safety Network in our next “Ftag of the Week” post.) To be compliant with F877, though, the following information needs to be included in the resident record:

• Documentation that the resident/ representative was educated regarding the benefits and potential side effects of the COVID-19 vaccine
• Documentation that the resident/ representative either accepted and received the vaccine or did not receive the vaccine due to refusal, prior vaccination or contraindication to having the COVID-19 vaccine. If there is a contraindication, it must be appropriately documented.

Documentation should include the date that the education was provided, the date the vaccine was offered and if the resident representative is making the decision, the name of the representative. Samples of the educational materials used to educate residents should be included.

Likewise, for staff, documentation needs to be included in the employee record. This includes:

• Documentation that the staff member was educated regarding the benefits and potential side effects of the COVID-19 vaccine
• Documentation that the staff member either accepted and received the vaccine or did not receive the vaccine due to refusal, prior vaccination, or contraindication to having the COVID-19 vaccine.

The facility must document the vaccination status of each staff member, including immunized, not immunized or fully immunized. If a staff member received the COVID-19 vaccine at a different location outside the facility, CMS notes that the facility should request vaccination documentation from that individual to confirm his/her vaccination status.

On Survey

The Infection Prevention, Control & Immunizations Facility Task is being updated to include the new Ftag, and CMS is also going to be updating its associated survey resources. During survey, the survey team will request the facility provide information on how residents/ representatives and staff are educated about and offered the vaccine.

They will be confirming that they were provided education on the COVID-19 vaccine and were offered the vaccine as outlined in the above regulatory requirements.  If it seems like this is the “never ending” story, it is!