On May 11, 2021, the Centers for Medicare & Medicaid Services (CMS) published an interim final rule with comment period that establishes long-term care (LTC) facility vaccine requirements for residents and staff. In addition, CMS has updated tools used by surveyors to assess compliance with these new requirements.
The LTC facility vaccine immunization interim final rule includes new requirements for educating residents or resident representatives and staff regarding the benefits and potential side effects associated with the COVID-19 vaccine and offering the vaccine. Furthermore, LTC facilities must report COVID-19 vaccine and therapeutics treatment information to the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN). Facilities must begin including vaccination and therapeutic data reporting in facility NHSN submissions by 11:59 p.m. Sunday, June 13, 2021. CMS will begin reviewing for compliance with the new vaccination reporting requirements Monday, June 14, 2021. To be compliant with the new reporting requirements, facilities must submit the data through the NHSN reporting system at least once every seven days. Facilities may choose to submit multiple times a week. Noncompliance related to the new requirements for educating and offering COVID-19 vaccination to residents and staff will be cited at F-Tag 887, and noncompliance related to COVID-19 vaccination reporting will be cited at F-Tag 884. The revised requirements for §483.80 Infection Control are as follows:
(d) Influenza, pneumococcal, and COVID-19 immunizations.
(3) COVID-19 immunizations. The LTC facility must develop and implement policies and procedures to ensure all the following:
(i) When COVID-19 vaccine is available to the facility, each resident and staff member is offered the COVID-19 vaccine unless the immunization is medically contraindicated, or the resident or staff member has already been immunized;
(ii) Before offering COVID-19 vaccine, all staff members are provided with education regarding the benefits and risks and potential side effects associated with the vaccine;
(iii) Before offering COVID-19 vaccine, each resident or the resident representative receives education regarding the benefits and risks and potential side effects associated with the COVID-19 vaccine;
(iv) In situations where COVID-19 vaccination requires multiple doses, the resident, resident representative, or staff member is provided with current information regarding those additional doses, including any changes in the benefits or risks and potential side effects associated with the COVID-19 vaccine, before requesting consent for administration of any additional doses.
(v) The resident, resident representative, or staff member has the opportunity to accept or refuse a COVID-19 vaccine, and change their decision; and
(vi) The resident’s medical record includes documentation that indicates, at a minimum, the following:
(A) That the resident or resident representative was provided education regarding the benefits and potential risks associated with COVID-19 vaccine; and
(B) Each dose of COVID-19 vaccine administered to the resident, or
(C) If the resident did not receive the COVID-19 vaccine due to medical contraindications or refusal.
(vii) The facility maintains documentation related to staff COVID-19 vaccination that includes at a minimum, the following:
(A) That staff were provided education regarding the benefits and potential risks associated with COVID-19 vaccine;
(B) Staff were offered the COVID-19 vaccine or information on obtaining COVID-19 vaccine; and
(C) The COVID-19 vaccine status of staff and related information as indicated by NHSN.
(g)(1)(viii) The COVID-19 vaccine status of residents and staff, including total numbers of residents and staff, numbers of residents and staff vaccinated, numbers of each dose of COVID-19 vaccine received, and COVID-19 vaccination adverse events; and
(ix) Therapeutics administered to residents for treatment of COVID-19.
The revised requirements for F887: COVID-19 Immunization include the following:
GUIDANCE:
In order to protect LTC residents from COVID-19, each facility must develop and implement policies and procedures that meet each resident’s, resident representative’s, and staff member’s information needs and provides vaccines to all residents and staff that elect them.
Education
All residents and/or resident representatives and staff must be educated on the COVID-19 vaccine they are offered, in a manner they can understand, and receive the FDA COVID-19 EUA (Emergency Use Authorization) Fact Sheet before being offered the vaccine. The Food and Drug Administration (FDA) requires that vaccine recipients or their representative are provided with certain vaccine-specific EUA information to help make an informed decision about vaccination. Fact Sheets can be accessed here.
CMS recommends that staff work with their LTC facility’s Medical Director and Infection Preventionist and use the CDC and FDA resources as the source of information for their vaccination education initiatives. The CDC’s LTC Facility Toolkit can be accessed here.
Offering Vaccinations
LTC facilities must offer residents and staff vaccination against COVID-19 when vaccine supplies are available to the facility. Screening individuals prior to offering the vaccination for prior immunization, medical precautions and contraindications is necessary for determining whether they are appropriate candidates for vaccination at any given time.
Vaccine Administration
For residents and staff who opt to receive the vaccine, vaccination must be conducted in accordance with CDC, ACIP, FDA, and manufacturer guidelines. All facilities must adhere to current infection prevention and control recommendations when preparing and administering vaccines. Administration of any vaccine includes appropriate monitoring of recipients for adverse reactions, and LTC facilities must have strategies in place to appropriately evaluate and manage post-vaccination adverse reactions among their residents and staff, per 483.45(d), F757. Particularly for COVID-19 vaccines, safety monitoring is required under the associated EUAs.
Vaccination Adverse Event Reporting
In accordance with FDA requirements, select adverse events for COVID-19 vaccines must be reported to the Vaccine Adverse Event Reporting System (VAERS), (vaccine administration errors, serious adverse events, multisystem inflammatory syndrome (MIS) in children or adults, and cases of COVID-19 that result in hospitalization or death). Any revised safety reporting requirements must also be followed. For additional information see VAERS – Vaccine Adverse Event Reporting System at https://vaers.hhs.gov.
Vaccination Refusal
Residents and their representatives have the right to refuse the COVID-19 vaccine in accordance with Resident Rights requirements at 42 CFR 483.10(c)(6) and tag F578. Additionally, the regulation at §483.10(b)(2) states, “The resident has the right to be free of interference, coercion, discrimination, and reprisal from the facility in exercising his or her rights and to be supported by the facility in the exercise of his or her rights as required under this subpart.” Therefore, facilities cannot take any adverse action against a resident or representative who refuses the vaccine, including social isolation, denied visitation and involuntary discharge. Facilities should follow state law and facility policies with respect to staff refusal of vaccination.
Documentation
The resident’s medical record must include documentation that indicates, at a minimum, that the resident or resident representative was provided education regarding the benefits and potential side effects of the COVID-19 vaccine, and that the resident (or representative) either accepted and received the COVID-19 vaccine or did not receive the vaccine due to medical contraindications, prior vaccination, or refusal. If there is a contraindication to the resident having the vaccination, the appropriate documentation must be made in the resident’s medical record. Documentation should include the date the education and offering took place, and the name of the representative that received the education and accepted or refused the vaccine, if the resident has a representative that makes decisions for them. Facilities should also provide samples of the educational materials that were used to educate residents. The facility must maintain documentation that each staff member was educated on the benefits and potential side effects of the COVID-19 vaccine and offered vaccination unless medically contraindicated or the staff member has already been immunized. Compliance can be demonstrated by providing a roster of staff that received education (e.g., a sign-in sheet), the date of the education, and samples of the educational materials that were used to educate staff. The facility must document the vaccination status of each staff member (i.e., immunized or not), including whether fully immunized (i.e., completed the series of multi-dose vaccines).
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. LTC administrators and clinical leadership are encouraged to track vaccination coverage in their facilities and adjust communication with residents and staff accordingly to facilitate understanding and knowledge of the benefits of vaccination.
INVESTIGATIVE PROCEDURES
Use the Infection Prevention, Control & Immunizations Facility Task, along with the above interpretive guidance, when determining if the facility meets the requirements for, or investigating concerns related to COVID-19 vaccination of residents and staff.
Updates to the Survey Process for F887 are as follows:
To determine compliance with §483.80(d)(3), surveyors will request a facility point of contact to provide information on how residents and staff are educated about and offered the COVID-19 vaccine, including samples of educational materials. Surveyors will also request a list of residents and staff and their COVID-19 vaccination status from which they will select a sample of residents and staff to review records and conduct interviews to confirm they were educated on and offered the COVID-19 vaccine in accordance with the new requirements. CMS will update the CMS-20054: “Infection Prevention, Control, & Immunizations” Facility Task to include the new requirement at F887 for educating residents or resident representatives and staff and offering the COVID-19 vaccine. Additionally, CMS will update associated survey documents, which will be found under the “Survey Resources” link in the Downloads Section of the CMS Nursing Homes website. The updated documents will also be added to the Long-Term Care Survey Process software application.
F884: Reporting – National Healthcare Safety Network (NHSN) requirements are as follows:
42 CFR 483.80(g)(1)(viii)-(ix) requires LTC facilities report, on a weekly basis, the COVID-19 vaccination status of residents and staff, total numbers of residents and staff vaccinated, each dose of vaccine received, COVID-19 vaccination adverse events, and therapeutics administered to residents for treatment of COVID-19 through NHSN’s LTCF COVID-19 Module. Their website can be accessed here. LTC facility administrators and clinical leadership are encouraged to track vaccination coverage in their facility, which can help them target efforts to improve vaccination coverage. Facilities may use the COVID-19 Vaccination module in NHSN to track aggregate vaccination coverage.
Refer to CMS memorandum QSO-20-29-NH for additional NHSN reporting requirements under F884 as well as instructions on registering, enrolling, and reporting to NHSN. For NHSN questions, please email: NHSN@cdc.gov and add “Weekly COVID-19 Vaccination” in the subject header. Facilities must continue submitting their COVID-19 data to NHSN at least weekly, but no later than Sunday at 11:59 p.m., each week.
Enforcement for F884
Compliance with F884 requires facilities to continue to report COVID-19 data through NHSN’s LTCF COVID-19 Module, and now, with finalization of the new reporting requirements at §483.80(g)(viii) and (ix), they must begin reporting vaccination data for residents and staff and the use of therapeutics for residents.
As has been done since June 2020, CMS will continue to receive the CDC NHSN reported data and review for timely and complete reporting of all data elements. Facilities identified as not meeting all reporting requirements under the provisions at §483.80(g)(1), including the new vaccination reporting requirements, will receive a deficiency citation at F884 on the CMS 2567, Statement of Deficiencies, at a scope and severity level of F (no actual harm with a potential for more than minimal harm that is not an Immediate Jeopardy [IJ] and that is widespread).
Failure to report the required elements to NHSN (including the new vaccination reporting requirements) will result in a single deficiency at F884 for that reporting week. In accordance with §488.447, a determination that a facility has failed to comply with the requirements to report weekly to the CDC pursuant to §483.80(g)(1)-(2) (tag F884) will result in a civil money penalty (CMP) imposition. Enforcement for F884 follows a progressive pattern, which leads to an increase of the CMP amount for each subsequent occurrence of noncompliance, not to exceed the maximum amount set forth in §488.408(d)(1)(iii), as specified in §488.447(a)(2).2 The amount of the CMP imposed is incrementally increased based on the provider’s history of noncompliance with F884 since June 2020 when providers were first required to start reporting COVID-19 related data to the CDC.
Per enforcement requirements at §488.447, failure to meet reporting requirements at §483.80(g)(1) will result in a CMP starting at $1,000 for the first occurrence of a failure to report. For each subsequent week that the facility fails to submit the required report, the noncompliance will result in an additional CMP imposed at an amount increased by $500 and added to the previously imposed CMP amount for each subsequent occurrence.
CMS Interim Final Rule-COVID-19 Vaccine Immunization Requirements for Residents and Staff can be accessed here.
Additional COVID-19 vaccine resources include:
COVID-19 Vaccination Training Programs and Reference Materials for Healthcare Professionals can be accessed here.
Immunization Action Coalition – for education and implementation materials can be accessed here.
CDC’s Clinical Resources for COVID-19 Vaccine can be accessed here.
Understanding the Pharmacy Partnership for Long-Term Care Program can be accessed here.
Post Vaccine Considerations for Residents and HCP can be accessed here.
Compliance Perspective
Issue
Nursing facilities must remain vigilant against the spread of COVID-19. A critical strategy that can be taken to help decrease the spread of COVID-19 is the COVID-19 vaccination, along with other CDC recommendations to help reduce transmission of the virus. As more is researched and learned about the COVID-19 virus, healthcare personnel must stay up-to-date on the important changes and train all staff on the available information.
Discussion Points
- Review your Infection Control Plan and your policy and procedure on the COVID-19 vaccination. Ensure that both include the most up-to-date information from the CDC. Develop a process for ensuring that all required education and vaccination data is accurately recorded and is reported timely per CMS requirements.
- Train all staff on your Infection Control Plan and your COVID-19 policies for vaccination and prevention of the spread of the virus. Provide education to residents, resident representatives, and staff prior to offering the COVID-19 vaccine. Train appropriate staff on the need to record and report vaccination status for residents and staff alike. Place training documentation in each employee’s education file.
- Periodically audit to ensure that all staff are following your Infection Control Plan, and that staff are aware of the benefits and risks associated with the COVID-19 vaccination. Audit vaccine education records, consent completion, and administration rates and provide additional education where needed. Monitor to ensure that vaccination reporting occurs each week as required beginning Sunday June 13, 2021.
