• Employees 
• Licensed Practitioners 
• Students, Trainees, Volunteers 
• Individuals who provide care, treatment, or other services for the facility and/or its residents under contract or other arrangement.  

• Those who exclusively provide telehealth or telemedicine services outside of the facility setting and who do not have any direct contact with residents and other staff.  
• Staff who provide support services for the facility that are performed exclusively outside of the facility setting and do not have any direct contact with residents and other staff.  

• Have received at least the first dose of a two-dose series or the single dose of the J&J vaccine.  
• Requested (or granted) a medical or religious exemption.  
• Be eligible for a temporary delay in vaccination.   

Within 60-days of issuance of the QSO, on March 15, 2022, 100% of staff must: 

• Receive the necessary doses to complete the primary vaccine series.  
• Be granted a medical or religious exemption.  
• Be eligible for a temporary delay in vaccination.  

Within 90-days of issuance of the QSO, all of the required elements of the IFR must be implemented.  

• Have a process for staff to request a medical or religious exemption.  
• The process for exemptions must include who the employee should request the exemption from.  
• Have a process for collecting and reviewing medical or religious exemptions.  

• Must include the clinical contraindications for the medical exemption.  The Interpretive Guidance under F888 states that the CDC recognizes allergies and certain medical conditions as clinical contraindications for vaccination.  
• Must include which vaccinations the employee is contraindicated to receive.  
• Must include a statement from the medical provider that the employee should be exempt from the facility’s COVID-19 vaccination requirements for staff based on the recognized clinical contraindications.  
• The medical provider must be practicing within their Scope of Practice and the medical provider cannot be the person requesting the medical exemption.  

Religious Exemptions:  

• Must follow the EEOC guidance for religious exemptions.  

Employees may meet criteria for a temporary delay in vaccination.  The interpretive guidance recognizes the following reasons for a temporary delay in vaccination. 

• Received Monoclonal Antibodies 
• Received Convalescent Plasma  
• Has active COVID-19 infection 

Reassigning staff:  

• To non-patient care areas 
• To duties that can be performed remotely 
• To duties that limit exposure to the most at-risk population including residents who are immunocompromised and/or unvaccinated.  

Requiring staff to utilize additional PPE when the provider is located in an area with low to moderate community transmission such as: 

• Eye protection at all times 
• Use of an N95, equivalent or higher-level respirator for source control, regardless of whether they are providing direct care or otherwise interacting with residents.  

Requiring staff to adhere to physical distancing even if located in an area with low to moderate community transmission.  

Requiring at least weekly testing regardless of whether the facility is in a county with low to moderate community transmission.  

Consulting with local or state public health for additional mitigation measures to reduce the risk of transmission.  

• Identify each staff’s role, assigned work area, and how they interact with residents.  
• Identification of staff that are teleworkers and roles.  
• Identification of contractor, volunteer, and/or student designation.  
• The name of the vaccine the staff member received.  
• Dates of vaccination. If the staff member has not yet received both primary doses in an mRNA series, include the date the staff member is scheduled to receive the second dose.  
• Booster dose status, including the name of the vaccine and the date administered.  
• Whether they’ve requested or been granted a medical or religious exemption (including what type of exemption they’ve requested or been granted). 
• Temporary delays in vaccination, including why they have a temporary delay and dates they are eligible for vaccination. 
•  What additional mitigation measures the staff member will have based on any exemptions or temporary delays in vaccination.  

Staff that have obtained no doses of any vaccine over staff that have received a single dose of a multi-dose vaccine.  For example, this could include a deadline that staff must receive the second dose.  

The contingency plan should include the actions that the provider will take if the deadline is not met. This could include but is not limited to:  

• Advertising for a replacement of the staff member. 
• Obtaining vaccinated temporary staff members until permanent replacements can be found.  

• The policy and procedure is developed and implemented, including all required components of the policy and procedure.  
• 100% of staff have received at least one dose of the vaccine, have a pending request for or been granted an exemption, or have a temporary delay in vaccination.  
• If less than 100% of all staff are identified as meeting the requirements the provider will be considered non-compliant.  
• If the provider has greater than 80% and has a plan to achieve 100% within 90 days from the release of the QSO, the provider would not be subject to enforcement action.  
• If the surveyors determine that the provider has greater than 80% vaccination, however, a threat is identified to the resident’s health and safety, the surveyors are encouraged to work with CMS regional office to determine if enforcement action is necessary depending on the severity of the deficiency and the type of provider.  

• The policy and procedure is developed and implemented.  
• 100% of staff have received all the necessary doses to complete the vaccine series, have been granted an exemption, or a temporary delay in vaccination is indicated.  
• Less than 100% of staff meeting the above criteria would be considered non-compliant.  
• If the provider has greater than 90% and has a plan to achieve 100% compliance within 90 days of release of the QSO, the provider would not be subject to enforcement action.  
• If the surveyors determine that the provider has greater than 90% vaccination, however, a threat is identified to the resident’s health and safety, the surveyors are encouraged to work with CMS regional office to determine if enforcement action is necessary depending on the severity of the deficiency and the type of provider.  

• If the percentages are reasonably consistent (within 10% of each other) no further investigation is warranted.  
• If the percentages are not reasonably consistent the surveyor should investigate to determine the reason for the inconsistency. This is conducted by reviewing the providers documentation and interviewing staff that are responsible for reporting to NHSN to determine which source is incorrect.  
• If the surveyor determines that the information presented to the surveyor is incorrect (NHSN is correct), or both sources are incorrect, this likely demonstrates the facility’s failure to have a process for tracking and documenting the COVID-19 status for all staff and F888 should be cited.  
• If the surveyor determines that the information reported to NHSN is incorrect (onsite information is correct) the surveyor should instruct the facility to immediately correct the information in the NHSN system.  If the surveyor identifies that a data field is blank, instruct the facility to obtain additional information on submitting data to NHSN.  

• Met the requirements for staff vaccination (100%) and 
• 1 or more components of the policy and procedure were not developed or implemented.  
• Has the possibility to effect all residents, which is why F888 would be cited in this circumstance.  

• Did not meet the requirements of staff vaccination; and 
• No resident outbreaks
  

• Did not meet the requirements of staff vaccination; and 
• 1 or more components of the policies and procedures were not developed and implemented.  

• Did not meet the requirements of staff vaccination; and 
• 3 or more resident infections in the last 4 weeks which did not result in hospitalization or death, or the likelihood for IJ for one or more residents; and  
• 1 or more components of the policies and procedures were not developed and implemented.  

• Did not meet the requirements of staff vaccination or have no policies and procedures developed or implemented and 
• 3 or more resident infections in the last 4 weeks resulting in at least one resident experiencing hospitalizations or death. 
  

• Did not meet the requirements of staff vaccinated; and  
• 3 or more resident infections in the last 4 weeks that did not result in serious harm or death; and 
• One of the following: 

• Any observations of noncompliant infection control practices by staff (such as failing to properly don PPE) or 

• 1 or more components of the policies and procedures to ensure staff vaccination were not developed or implemented.  

• More than 40% of staff are unvaccinated and there is evidence of a lack of effort to increase staff vaccination rates.  

• The facility has met the requirement of staff vaccination by staff obtaining additional doses or replacing unvaccinated staff with vaccinated staff, or  
• The combined number of staff that are vaccinated or have at least one dose of a multiple vaccine series and have their second dose scheduled.  

• Has not met the requirement of staff vaccinated but has provided evidence that some of the unvaccinated staff have obtained their first dose, and  
• Other unvaccinated staff are scheduled for their first dose.  

• Correcting any gaps in the policies and procedures.  
• Implementation of the contingency plan, that should include a deadline for each unvaccinated staff to have received their first dose of a vaccine.  
• Implementation of additional precautions to mitigate the spread of COVID-19 by unvaccinated staff.  

• If the facility has no or has limited access to the vaccine and has documented attempts to obtain vaccinate access.  
• If the facility provides evidence that they have taken aggressive steps to have all staff vaccinated such as advertising for new staff, hosting vaccine clinics, etc.