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Federal Register / Vol. 86, No. 91 / Thursday, May 13, 2021 / Rules and Regulations
infrequently meaning less than once weekly. We believe it would be overly burdensome to mandate that each ICF
IID educate and offer the COVID19
vaccine to all individuals who enter the facility. However, while facilities are not required to educate and offer vaccination to these individuals, they may choose to extend their education and offering efforts beyond those persons that we consider to be staff for purposes of this rulemaking. We do not intend to prohibit such extensions and encourage facilities to educate and offer vaccination to these individuals as reasonably feasible.
We recognize that facilities may choose to use a broader definition of staff. We note that CDC categorizes staff in the NHSN as: Ancillary service employees, nurse employees, aides, assistant and technician employees, therapist employees, physician and licensed independent practitioner employees and other health care providers. Categories are further broken down into environmental, laundry, maintenance, and dietary services;
registered nurses RNs and licensed practical/vocational nurses; certified nursing assistants, nurse aides, medication aides, and medication assistants; therapists such as respiratory, occupational, physical, speech, and music therapists and therapy assistants; physicians, residents, fellows, advanced practice nurses, and physician assistants; and persons not included in the employee categories listed, regardless of clinical responsibility or patient contact, including contract staff, students, and other non-employees.58
For purposes of the CMS
requirements related to COVID19
education and vaccination issued in this rule, we believe that the NHSN
definition may be impractical. In addition to regularly employed personnel, many facilities have services provided directly to residents under contract, such as physical therapy, occupational therapy, behavior therapy, case management, and mental health services. There are also individuals who may enter the facility for specific purposes and for a limited amount of time, such as delivery personnel, plumbers, and other vendors. Even regular volunteers may enter the ICF
IID infrequently. We do not believe that mandating these requirements for every individual who enters the facility at any time is necessary to protect the clients and staff. In addition, we believe it would be overly burdensome for the 58 https www.cdc.gov/nhsn/ltc/weekly-covidvac/index.html.

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ICFIID to educate and offer the COVID19 vaccine to all individuals who enter the facility. Staff and resources are limited in ICFsIID, and therefore staff may not be available to educate and offer the vaccine to every individual that enters.
We are requiring that ICFIID staff that is, individuals who are eligible to work in the facility on a routine, or at least once weekly, basis be educated about the benefits and risks and potential side effects of the COVID19
vaccine. Educating staff further about the development of the vaccine, how the vaccine works, and the particulars of multi-dose vaccine series is encouraged but not required. Broader understanding of the vaccine will support the national effort to vaccinate against COVID19.
Staff should be educated to help them understand the importance of vaccination for helping to safeguard clients, personal health, and broader community health. Better understanding of the value and safety of the vaccines will allow staff to appropriately educate clients and representatives about the benefits of accepting the vaccine.
Staff education must cover the benefits and risks or possible side effects of vaccination, which typically include reduced risk of COVID19
illness, and related serious COVID
outcomes, including hospitalization and death, the bolstered protection offered by completing a full series of multi-dose vaccines if used, and other benefits identified as research and immunization continues. Staff education must also address risks associated with vaccination, which should include potential side-effects of the vaccine, including common reactions such as aches or fever, and rare reactions such as anaphylaxis. The low likelihood of severe side effects should be included in this education. If other benefits, risks, or side-effects are identified in the future, whether through research, or authorization or licensing of new COVID19 vaccine products, those facts should be incorporated into education efforts. Staff should also be informed about ongoing opportunities for vaccination. Staff should be provided education on culturally appropriate ways to educate and share information with clients to prevent misinformation, confusion, or loss of credibility. In addition to ongoing education and informational updates for all staff members, we expect that new staff will be screened to determine vaccination status, and potential need for appropriate education on COVID19
vaccines during their onboarding or orientation. CDC and FDA have developed a variety of clinical
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educational and training resources for health care professionals related to COVID19 vaccines, and CMS
recommends that nurses and other clinicians work with their ICFIIDs Medical Director and use CDC resources as the source of information for their vaccination education initiatives. Each manufacturer is also developing educational and training resources for its individual vaccine candidate.
Building vaccine understanding broadly among staff, clients, and parent if the client is a minor, or legal guardian or representative, as well as dispelling vaccine misinformation, are critical to vaccine uptake rates.
The facility vaccination policies and procedures must be developed as part of the COVID19 immunization requirements at 483.460a4.
Facilities can determine where they keep the documentation that demonstrates educational efforts and offering the vaccine to staff. Some examples of evidence of compliance may include sign in sheets, descriptions of materials used to educate, and summary notes from all-staff question and answer sessions. There may be posters and flyers announcing appointments for vaccine clinic days or other vaccination opportunities.
b. ICFIID Clients New 483.460a4iii requires that ICFIID clients, or their representatives are educated about vaccination against COVID19. Explaining the risks and benefits of any treatments to a client or representative in a way that they understand is the standard of care. In ICFsIID, consent or assent for vaccination should be obtained from clients or representatives and documented in the clients medical record. It is important to talk to clients and representatives to learn why they may be declining vaccination and tailor educational messages accordingly, that is, by addressing specific questions or concerns.
Clients of ICFsIID and their representatives must be offered education about vaccine immunization development, administration, and evaluation. Representatives must be included as a component of the ICF
IIDs vaccine education plan as the representatives may be called upon for consent and/or may be asked to assist in encouraging vaccine uptake by the client.
In addition to the topics addressed above for education of ICFIID staff, education of clients and representatives should cover the fact that, at this time while the U.S. Government is purchasing all COVID19 vaccine in the
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