Just when we thought that we may finally have seen an end to new infection control-related Federal regulations, the Centers for Medicare and Medicaid Services (CMS) left providers with a holiday gift for the new year. In a December 28, 2021 QSO Memo, “Guidance for the Interim Final Rule – Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination,” CMS provided lengthy details on how nursing homes and other providers will be surveyed for compliance with staff COVID-19 vaccination requirements. While the guidance is restricted for some states, the majority of the country should be prepared for surveyors to be reviewing vaccination rates, policies & procedures and any other detail that CMS could think of to ensure facilities are protecting residents through staff vaccination efforts. As the number of COVID-19 cases continues to rise among both nursing home staff and residents, thanks in large part to the Omicron variant, CMS is tightening the screws on providers to have 100% staff vaccination rates.
In this post, we will review the new regulatory requirements. In a second part of this “Ftag of the Week,” we will recap the guidance to surveyors so providers can understand the impact that their staff vaccination rates – as well as their documentation and tracking procedures – will have on their compliance levels.
F888 COVID-19 Vaccination of Facility Staff
F888 is a brand-new regulation that spells out the new requirements related to COVID-19 vaccination of facility staff. The regulation has several parts, but overall requires providers to develop and implement policies and procedures that will ensure all staff are fully vaccinated against COVID-19. Unfortunately, this regulation does not mean that other recently implemented regulations, including all the COVID-19-related reporting and testing requirements, are going away. Instead, the data that providers have been submitting to the CDC’s National Health Safety Network (NHSN) related to COVID-19 staff vaccination data will now be utilized by surveyors to determine compliance with the vaccination requirements set out under F888.
Which Staff Need to Be Included?
Per F888, a facility’s Staff Vaccination policy and procedure applies to facility staff who provide any care, treatment or other services for the facility and/or its residents, regardless of clinical responsibility or resident contact. This includes facility employees, licensed practitioners, students/trainees, volunteers and individuals who provide care/treatment/other services under contract or other arrangement. So that means that the majority of the facility’s staff will need to be vaccinated, with few exceptions. Staff who do not have any direct contact with residents or other staff members who are exclusively providing telehealth/telemedicine services are one exception to this requirement, presumably because they are not coming to the building to provide services or interact with anyone. This is in line with the second group of staff who are exempt from these requirements – staff who perform services exclusively outside of the facility and do not have any direct contact with residents or other staff.
The regulation states that nursing homes are not required to ensure that individuals who “very infrequently provide ad-hoc non-healthcare services” are vaccinated against COVID-19. This provides clarity to earlier guidance which seemed to generally imply that anyone setting foot in the building needed to be vaccinated. Instead, those service providers who enter the facility infrequently, such as for an annual inspection of equipment, do not need to be vaccinated as part of this requirement.
What Needs to be Covered in Your Policies and Procedures
If you do not have a good system in place for tracking staff vaccinations, completing required documentation and reporting, as well as ensuring staff are becoming fully vaccinated, you probably will have you completed the requirements for this regulation. Your P&P needs to include:
- Your organization’s process for ensuring all staff (except those with pending requests for exemptions/ granted exemptions or those whose vaccinations have been temporarily delayed) have received, at a minimum, the first dose of the primary vaccine series in a multi-dose COVID-19 vaccine (i.e., Pfizer or Moderna) or a single-dose vaccine (i.e., Janssen) prior to providing any care, treatment or other services for the facility and/or its residents.
Providers are not off the hook if staff members receive one dose and then do not complete the series if it is a multi-dose COVID-19 vaccine.
This means pre-employment vaccination requirements should be in place to ensure staff have received at least one dose of a COVID-19 vaccine. However, providers are not off the hook if staff members receive one dose and then do not complete the series if it is a multi-dose COVID-19 vaccine. Facilities must ensure staff are fully vaccinated.
“Fully Vaccinated” continues to be defined as staff for whom it has been 2 weeks or more since the completion of their primary vaccination series for COVID-19.
“Primary Vaccination Series” is defined as staff who have received either a single-dose vaccine or all required doses of a multi-dose vaccine.
- Your P&P also needs to set out your process for ensuring that all staff are fully vaccinated for COVID-19 (except for employees with exemptions/delays as noted prior). So, after staff have received one dose, how are you ensuring they stay on target to receive the second dose within the appropriate timeframe? While some states have already mandated full vaccination, including timeframes for completion of a multi-dose vaccine series, this is something many providers will need to ensure there is good follow-up for.
There are a lot of documentation requirements that need to be planned for as well. F888 requires that your P&P include a process for:
- Tracking and securely documenting the COVID-19 vaccination status of all staff
- Tracking and securely documenting the vaccination status of any staff who have received any booster doses recommended by the CDC
The facility’s tracking mechanism must include each staff’s role, assigned work area and how they interact with residents. Overall, the required data to be captured is very granular, including data points such as:
- Each staff member’s vaccination status, including specific vaccine received, dates of each dose received and the date of the next scheduled dose if using a multi-dose vaccine
- Specific vaccine booster received, as well as date of administration, for any staff receiving boosters.
Don’t forget that your P&P needs to include how you are going to address all things related to exemptions or delays. This includes having a process in place to address:
- How staff may request an exemption from vaccination requirements based on an applicable Federal law
- How requests for exemptions that have been granted by the facility will be tracked and securely documented
- Ensuring all documentation that supports staff requests for medical exemption has been signed and dated by a licensed practitioner. The documentation must confirm a recognized clinical contraindication to COVID-19 vaccines. The practitioner may not be the same person requesting the exemption and must be acting within the scope of his/her practice.
The documentation related to the exemption must include all information that specifies which of the authorized COVID-19 vaccines are clinically contraindicated for the individual to receive as well as the recognized clinical reasons for the contraindications. Additionally, the authorizing practitioner must provide a statement recommending that the individual be exempted from the organization’s vaccination requirements based on these recognized contraindications.
“Clinical contraindications” are defined in the regulation as conditions or risks that preclude the administration of a treatment or intervention, and in this case, refer to a COVID-19 vaccination. As such, the guidance directs healthcare providers to review the CDC’s “Summary Document for Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States” for more information.
However, the guidance also spells out information specific to the COVID-19 vaccination. Per the QSO Memo: “According to the CDC, for COVID-19 vaccines, a vaccine is clinically contraindicated if an individual has a severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a component of the COVID-19 vaccine or an immediate (within 4 hours of exposure) allergic reaction of any severity to a previous dose or known (diagnosed) allergy to a component of the vaccine.”
There also needs to be a process in place for tracking and documenting temporary delays to vaccination. If an individual’s COVID-19 vaccination is to be temporarily delayed (as recommended by CDC) due to clinical precautions and considerations, the facility must ensure that when the delay ends, that the staff member does not fall through the cracks and not be vaccinated timely. The QSO Memo states that individuals with acute illness secondary to COVID-19 or individuals who have received monoclonal antibodies or convalescent plasma for COVID-19 treatment may fall into this category of staff whose vaccinations are temporarily delayed.
What’s Your Contingency Plan?
F888 requires that facilities have contingency plans in place for staff who are not fully vaccinated. These plans must include the actions that the facility would take when staff have indicated that they will not get vaccinates and do not qualify for an exemption. Will staff be suspended or terminated if they refuse to take the vaccine by a deadline set by the facility or state? If staff fail to take the vaccine, the facility needs to have a documented plan in place to identify what it will do to replace those staff, such as through enhanced recruitment efforts or using agency staff. What about staff who have received a temporary delay or exemption? What is the plan for those handful of employees to keep them, and your residents, safe?
If staff fail to take the vaccine, the facility needs to have a documented plan in place to identify what it will do to replace those staff.
Don’t Forget About Precautions
While the requirements for staff vaccinations seem to focus on tracking and documenting, it’s also important to think about how to protect staff who are not fully vaccinated or are otherwise exempt. Providers are required to ensure additional precautions are implemented that will mitigate the transmission and spread of COVID-19. F888 requires facilities to ensure that staff who are not yet fully vaccinated or who have a pending/granted exemption/temporary delay adhere to additional precautions. The regulation states that there are a variety of actions a facility can take to potentially reduce the risk of COVID-19 transmission, including:
- Reassigning staff who are not fully vaccinated to non-patient care areas or to duties that can be completed remotely.
- Assigning residents who are at the most risk, such as those who are immunocompromised or unvaccinated, to staff who are fully vaccinated.
- Requiring staff members who have not completed their primary vaccination series to follow additional precautions. These precautions could include universal source control and physical distancing in areas restricted from patient access, such as an employee break room, regardless of the county transmission level.
- Requiring testing at least weekly for exempted staff and staff who are not fully vaccinated, until the regulatory requirement is met. This testing would be in addition to following the CDC’s recommendations for testing unvaccinated staff in counties where there is substantial to high community transmission.
Requiring staff who have not completed their primary vaccination series to use a NIOSH-approved N95 or equivalent or higher-level respirator for source control, regardless of whether they are patient-facing or not.
View CMS QSO Memo “Guidance for the Interim Final Rule – Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination” (Ref: QSO-22-07-ALL) here. To view the Long-term Care and Skilled Nursing Facility “Attachment A” that is included as part of this Memo, click here.
In Part 2 of our “Ftag of the Week” for F888 COVID-19 Vaccination of Facility Staff, we will review what you need to know related to how CMS will measure your facility’s compliance with this regulation.
Need assistance with developing and/or implementing your organization’s policies and procedures? CMSCG can help. Contact us today to learn about our nursing home consulting services or fill out the inquiry form below.
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