BACKGROUND
On November 5, 2021, CMS published an interim final rule with comment period, entitled “Medicare and Medicaid Programs; Omnibus COVID-19 health Care Staff Vaccination.” This IFC revised the infection control requirements, adding a staff vaccination mandate for health care facilities participating in the Medicare and Medicaid programs. This week’s blog takes a deep dive into the CMS Vaccine Mandate and elements of compliance with F888.
Vaccination enforcement and survey compliance is broken down into 30-Day, 60-Day, and 90-Day guidelines from the date of the following CMS Memorandums:
- CMS Memorandum QAO-22-07-ALL was issued 12/28/21 for the initial group of states.
- CMS Memorandum QSO-22-09-ALL was issued 1/14/22 for the remaining states (with the exception of Texas).
A listing of State deadlines can be found here: FAQ: CMS Omnibus COVID-19 Vaccine Mandate
An updated Entrance Conference Worksheet and the COVID-19 Staff Vaccination Matrix are both available for download from CMS. Click Here and select the ‘Survey resources with Staff Vaccine Documents (01-28-2022) under Downloads
ESSENTIAL POLICIES AND PROCEDURES
Facilities must develop and implement policies and procedures for the following:
Ensure all staff are fully vaccinated
Under this mandate facilities must ensure all staff are fully vaccinated. Staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine. Note: The booster is not currently included in the definition of fully vaccinated.
- All Staff –defined as any 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 the following: (1) facility employees, (2) licensed practitioners, (3) students, trainees, and volunteers, and (4) individuals who provide care, treatment, or other services for the facility and/or its residents, under contract or by other arrangement.
- Staff who work exclusively outside of the facility setting and do not have any direct contact with residents and/or facility staff are exempt from this rule.
Process for Requesting Exemptions
Facilities must have a process by which staff may request exemption from COVID-19 vaccination based on an applicable Federal law. This process should clearly identify how an exemption is requested, and to whom the request must be made. Additionally, facilities must have a process for collecting and evaluating such requests, including the tracking and secure documentation of information provided by those staff who have requested exemption, the facility’s determination of the request, and documentation of any accommodations that are granted.
- Medical Exemption: A staff member who requests a medical exemption from vaccination must provide documentation signed and dated by a licensed practitioner acting within their respective scope of practice and in accordance with all applicable State and local laws. The individual who signs the exemption documentation cannot be the same individual requesting the exemption. Medical exemptions should be based on accepted reasons per CDC Guidance for Contraindications and Precautions for COVID-19 Vaccine.
- Non-Medical Exemptions, Including Religious Exemptions: Requests for non-medical exemptions, such as a religious exemption must be documented and evaluated in accordance with applicable federal law and each facility’s policies and procedures. CMS directs providers and suppliers to the EEOC Compliance Manual on Religious Descrimination for information on evaluating and responding to such requests. NOTE: Surveyors will not evaluate the details of religious exemptions nor the rationale for accepting or denying such requests.
Process for tracking and securely documenting Vaccines/Exemptions
Facility policies and procedures must include a process for tracking and securely documenting the following:
- COVID-19 vaccination status of all staff;
- COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC;
- Proper documentation for those staff who have requested, and for whom the facility has granted, an exemption from the staff COVID-19 vaccination requirements;
- Vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed per CDC guidance.
Accommodations of Unvaccinated Staff with a Qualifying Exemption
The facility should have a process in place to provide accommodations for individual staff members that have valid reasons for exemption. Accommodations for unvaccinated employees may be addressed in the facility’s policies and procedures.
Examples of accommodations include:
- Mandatory routine COVID-19 testing (based on local, state or CDC recommendations);
- Physical distancing from other staff and residents;
- Use of NIOSH approved N95 masks;
- Reassignment of duties.
Staff who have been granted an exemption to COVID-19 vaccination requirements should adhere to national infection prevention and control standards for unvaccinated health care personnel. Refer to:
Contingency Plans
Facilities are required to have a contingency plan for staff who are not fully vaccinated. This should include actions that will be taken when a staff member has indicated that they will not get vaccinated and do not qualify for an exemption. The plan should also address staff who are not fully vaccinated due to an exemption or temporary delay in vaccination. The plans should also indicate the actions the facility will take if the deadline is not met, such as actively seeking replacement staff through advertising or obtaining temporary vaccinated staff until permanent vaccinated replacements can be found.
SURVEY COMPLIANCE
Surveyors will begin surveying for compliance 30 days from the date of issuance of the QSO-22-07-ALL or QSO-22-09-ALL memorandums (depending upon the facility’s geographic location). Compliance will be verified during standard and complaint surveys.
Surveyors will review facility policy and procedures to determine that all required components have been developed, implemented and are being followed. They will review the facility’s vaccination status (based on staff working over the prior 4 weeks) using facility records and tracking data for all staff. A facility is in compliance when 100% of staff are vaccinated or have an exemption, and new staff have their first dose (or exemption) before starting to work.
Vaccination Formula for surveys conducted days 30-59 (after issuance of CMS Memo)
% Vaccinated = (#partially vaccinated + #completely vaccinated + #pending exemption + #granted emptions + #temporarily delayed) X 100, then divided by #total staff.
Vaccination Formula for surveys conducted on day 60 (after issuance of CMS Memo) and thereafter
% Vaccinated = (#completely vaccinated + #granted emptions + #temporarily delayed) X 100, then divided by #total staff.
Example
Facility vaccination status:
- Partially vaccinated staff = 20
- Completely vaccinated staff = 75
- Staff with pending exemption = 5
- Staff granted exemption = 10
- Staff temporarily delayed = 5
Total Staff = 150
NOTE: Facility vaccine records will be also be used to calculate a staff vaccination rate (using the same method as NHSN) and compare with the rate posted on NHSN. If the rate differs 10% or more, then an in-depth review will be conducted to determine the reason for the discrepancy. If data on NHSN is incorrect then the SNF must immediately update the NHSN data. If the facility records are found to be incorrect, then surveyors will cite F888 for poor record keeping.
Enforcement
Within the first 30 days after the deadline, enforcement will be suspended if:
- Staff vaccination rate is >80%
- Required Policies and Procedures are in place
- Facility has a plan to achieve 100% vaccination within 60 days
For 31-60 days after the deadline, enforcement will be suspended if:
- Staff vaccination rate is >90%
- Required Policies and Procedures are in place
- Facility has a plan to achieve 100% vaccination within 30 days
After 90 days non-compliance may result in enforcement actions.
F888 SCOPE AND SEVERITY
Scope will be based on staff vaccination rates
- Isolated >75%
- Pattern 61% to 75%
- Widespread <60%
Severity will be based on staff vaccination rates
- Level 4 (J, K, L) <100% vaccination and:
- 3 or more residents with COVID-19 in past 4 weeks, and at least 1 hospitalization or death; OR
- Non-compliance with infection control practices, OR
- 1 or more P&P components not developed or implemented
- Level 3 (G, H, I) <100% vaccination and:
- 3 or more residents with COVID-19 in past 4 weeks without hospitalization or death; AND
- 1 or more P&P components not developed or implemented
- Level 2 (D, E, F) <100% vaccination and:
- No resident infections; OR
- 1 or more P&P components not developed or implemented
- Level 1 (A, B, C) <100% vaccination and:
- 1 or more P&P components not developed or implemented
- Level 4 (J, K, L) <100% vaccination and:
Prior to day 90 of the enforcement deadline, surveyors may lower the Scope and Severity or enforcement action if the facility has documentation occurring prior to survey of:
- Limited or no access to vaccines, or
- Aggressive steps taken (such as advertising for new staff or hosting vaccination clinics, etc.) to have all staff vaccinated.
If a facility is 100% vaccinated but still has an outbreak, they should not be cited for F888 if they are following their policies and procedures for vaccination. However, a facility may get an Infection Control tag F880 if they are not following infection control practices.
ADDITIONAL NOTES
Vendors
- Contracted vendors must comply with the vaccine mandate. Facilities do not have to collect vaccine records for contracted vendors. If a surveyor requests vaccination data, then the facility can ask the vendor to provide it. If a vendor is found to be non- compliant, the facility will be cited.
- Refer to the CMS Vaccine Requirement Decision Tree to determine if a Vendor must comply with the vaccine mandate.
Exemptions
- Religious exemptions are counted differently in this regulation verses NHSN tracking. Religious exempt staff are included in calculating the vaccination rate for this regulation, but are not included in the NHSN tracking because they are counted as “declined.”
- There is no maximum number of staff to be granted exemptions. CMS is not evaluating the content of exemptions, but ensuring that facilities are following a consistent, compliant process.
SNF/ALF Staff
- If a facility has SNF and ALF beds, any staff that work in both levels of care, are included in this mandate. Staff that work only in the ALF portion of the facility are not included.
Visitors
- Visitors are not required to show proof of vaccination; however, residents can make it a condition for visitors to be fully vaccinated in order to visit.
Contact Proactive for assistance in achieving regulatory compliance. Join us for one or both of our monthly webinar series:
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