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Federal Register / Vol. 86, No. 91 / Thursday, May 13, 2021 / Rules and Regulations B. Intermediate Care Facilities for Individuals With Intellectual Disabilities 1. Offer and Provision of Vaccine to ICFIID Clients and Staff With this IFC, we are redesignating the current 483.460a4 to 483.460a5 and adding a requirement at new 483.460a4i to require that ICFsIID offer clients and staff vaccination against COVID19
when vaccine supplies are available.
The vaccine may be offered and provided directly by the ICFIID or indirectly, such as through a local health department, pharmacy, or doctors office. Vaccines may be administered onsite or at other appropriate locations. Implementation of COVID19 education and vaccination programs in ICFsIID will help protect clients and staff, allowing an eventual return to more normal routines, including timely preventive health care;
family, caregiver and community visitors; and group and individual activities. While we require that all clients and staff must be educated about the vaccine, we note that in situations where an individual has already received the vaccine or has a known medical contraindication that is, an allergy to vaccine ingredients or previous severe reaction to a vaccine, the facility is not required to offer vaccination to that person.52
The client, parent if the client is a minor, or legal guardian collectively, representative has the right to refuse treatment based on the requirement at 483.420a2 that states the facility must ensure the rights of all clients.
Therefore, the facility must inform each client and/or the representative regarding the clients medical condition, developmental and behavioral status, attendant risks of treatment, and the right to refuse treatment. Clients and their representatives on behalf of the client have the right to refuse vaccination.
For clients and staff who opt to receive the vaccine, vaccination must be conducted in a sanitary manner in accordance with CDC, FDA, 483.410b of the ICFIID CoPs, and manufacturer guidelines. As required by the provider agreements, COVID19 vaccination clinics must be conducted in a manner for safe delivery of vaccines during the COVID19 pandemic.53 All facilities should adhere to current CDC IPC
recommendations. Screening individuals for suspected or confirmed 52 https www.cdc.gov/coronavirus/2019-ncov/
vaccines/recommendations/specific-groups/
allergies.html.
53 https www.cdc.gov/vaccines/pandemicguidance/index.html.

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cases of COVID19, previous allergic reactions, and administration of therapeutic treatments is important for determining whether they are appropriate candidates for vaccination at any given time. According to current CDC guidelines, anyone infected with COVID19 should wait until infection resolves and they have met the criteria for discontinuing isolation.54 We note that indications and contraindications for COVID19 vaccination are evolving, and the director of nursing DON or nursing staff of the facility should be alert to any new or revised guidelines issued by CDC, FDA, vaccine manufacturers, and other expert stakeholders.
Staff at ICFsIID should follow the recommended IPC practices described on CDCs website for ICFsIID. For example, the website currently has documents entitled Guidance for Group Homes for Individuals with Disabilities and the Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 COVID19
Pandemic.55 56 These recommendations, which emphasize close monitoring of clients of group homes for individuals with disabilities or ICFsIID for symptoms of COVID19, universal source control, physical distancing, use of masks, hand hygiene, and optimizing engineering controls, are intended to protect staff, residents, and visitors from exposure to SARS-CoV2.
Administration of any vaccine includes appropriate monitoring of vaccine recipients for adverse reactions.
For the COVID19 vaccines, safety monitoring is also being conducted.57
CDC has information describing IPC
considerations for residents of ICFIIDs with systemic signs and symptoms following COVID19 vaccination. See Vaccine considerations for people with disabilities, located at https
www.cdc.gov/coronavirus/2019-ncov/
vaccines/recommendations/
disabilities.html. Post-vaccine considerations are listed out for consideration by ICFsIID clinical staff.
ICFsIID must have strategies in place to appropriately evaluate and manage immediate post-vaccination adverse 54 Interim Guidance on Duration of Isolation and Precautions for Adults with COVID19 CDC, https www.cdc.gov/coronavirus/2019-ncov/hcp/
duration-isolation.html.
55 https www.cdc.gov/coronavirus/2019-ncov/
community/group-homes.html.
56 https www.cdc.gov/coronavirus/2019-ncov/
hcp/infection-control-recommendations.html.
57 https www.fda.gov/vaccines-blood-biologics/
safety-availability-biologics/covid-19-vaccinesafety-surveillance.

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reactions among any individuals who are vaccinated on site, and risks and potential side effects of vaccination on clients.
CDC advises that COVID19
vaccination providers should document vaccine administration in their medical records within 24 hours of administration and report administration data as specified in their vaccine provider agreements and to applicable local vaccine tracking programs that is, Immunization Information System. While an ICFIID
is unlikely to be a COVID19
vaccination provider, all vaccinations should be appropriately documented.
While ICFIID staff may not have personal medical records with the ICF
IID, ICFsIID participating in voluntary NHSN reporting should appropriately document staff vaccinations in a manner that enables the facility to report in accordance with NHSN guidelines that is, in a facility immunization record, personnel files, health information files, or other relevant documentation.
2. COVID19 Disease and Vaccine Education a. ICFIID Staff Given the new and emerging qualities of COVID19 disease, vaccines, and treatments we recognize that education of clients and staff is critical. With this IFC, we are amending the conditions of participation at new 483.460a4ii to require that ICFIID staff are educated about vaccination against COVID19.
ICFIID staff are integral to the function of the ICFsIID and the health and wellbeing of clients. For the purposes of COVID19 vaccine education and offering, we consider ICFIID staff to be those individuals who work in the facility on a regular that is, at least once a week basis. We note that this includes those individuals who may not be physically in the ICFIID for a period of time due to illness, disability, or scheduled time off, but who are expected to return to work. In addition to facility-employed personnel, many facilities have services provided on-site, on a regular basis by individuals under contract or arrangement, including hospice and dialysis staff, physical therapists, occupational therapists, behaviorists, mental health professionals, and volunteers. These individuals would be included in staff who must be educated and offered the vaccine as available.
There are also individuals who may enter the facility for specific purposes and for a limited amount of time, such as delivery and repair personnel, or volunteers who may enter the ICFIID

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