Earlier this month, the Centers for Medicare & Medicaid Services (CMS) published an Interim Final Rule on COVID-19 Vaccine Requirements. This rule applies to residents, clients, and staff of Skilled Nursing Facilities (SNF) and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID). CMS also published a QSO memo to state survey agencies on how to operationalize this new requirement.
This rule specifies that facilities must develop and implement policies and procedures to:
- Educate all residents and staff about COVID-19 vaccines;
- Offer vaccination to all residents and staff; and
- Report to the CDC via the National Health and Safety Network (NHSN) vaccination status for residents and staff as well as use of any therapeutic treatments (e.g., monoclonal antibody). This requirement does not apply to ICFs-IID.
The rule was scheduled to go into effect on May 21, 2021. However, CMS has publicly stated that it will not enforce compliance until June 14.
AHCA/NCAL recommends that facilities implement several important steps before June 14 to ensure compliance with this new requirement.
- Develop a policy and procedure on offering and educating staff on the COVID-19 vaccine. AHCA/NCAL has developed a template policies and procedures for facilities to use to facilitate compliance with this new rule. In addition, AHCA/NCAL has developed a template declination form for facilities who want to use a declination form to help track staff and residents who decline the vaccine. Note that use of a declination form is not required by CMS.
- Track all staff and resident vaccination status. Providers must know their staff and resident vaccination status to comply with this rule. For residents, this should be documented in their medical record and include:
- Education provided to the resident or resident representative regarding the benefits and potential risks associated with the COVID-19 vaccine (including date and name of representative); and
- Each dose of the COVID-19 vaccine administered to the resident; or
- If the resident did not receive the COVID-19 vaccine due to medical contraindications or refusal.
For staff, you will need to develop a process to document that includes
- Staff were provided education regarding the benefits and potential risks associated with the COVID-19 vaccine (include date);
- Staff were offered the COVID-19 vaccine or information on obtaining the COVID-19 vaccine; and
- The COVID-19 vaccine status of staff and related information as indicated by NHSN.
Your database should also include which vaccine they received and the date of both shots, in case of the need for boosters later that are based on when and what vaccine a person received. To assist providers, AHCA/NCAL has developed a template staff vaccination log. Please note, under this rule, staff is defined as any individuals who work (including contractors or consultants) or volunteer in the facility once per week.
If you have not started tracking staff vaccination status, you can ask staff their vaccination status and for a copy of their vaccination card. Per the Equal Employment Opportunity Commission, you can ask the employee directly for proof of vaccination, but not their medical information. The requirement also indicates that “if a staff member is not eligible for COVID-19 vaccination because of previous immunization at another location or outside of the facility, the facility should request vaccination documentation from the staff member to confirm vaccination status.”
- Document education provided to staff and residents. Facilities should be prepared to provide samples of the materials they are using to educate staff and residents on the safety of the COVID-19 vaccine to surveyors. This must include a link to the Food and Drug Administration’s Emergency Use Agreement Fact Sheet for the vaccine(s) being offered:
- Re-educate and offer the COVID-19 vaccine to all staff and residents who previously declined. While the QSO Memo and IFR are unclear, the intent is to make sure all staff and residents who are not vaccinated have been educated and offered the vaccine. We believe this is a good opportunity to re-educate and offer the COVID-19 vaccine to all staff and residents who previously declined. This will allow you to document your education attempts, their refusal, and show the surveyors that you are making good faith efforts to comply with this rule.
- Start submitting to the NHSN today. Facilities should NOT delay in submitting their vaccination data to NHSN. Facilities are required to submit data via NHSN by June 13 at midnight in order to avoid penalties. However, submitting vaccination data at the last minute will very likely lead to challenges with the submission process that will not be resolved before the deadline. Facilities should start submitting data this week to the two modules to make sure they learn how to do it correctly. Providers do NOT need to upgrade to SAMS Level-3 access to submit vaccination data. Please read this vital blog post for additional info on submitting this to NHSN.
For more information, providers are encouraged to view the webinar recorded on this new rule or contact COVIDfirstname.lastname@example.org.