CMS Vaccine Mandate for Home Health, Hospice, Other Providers

This morning, November 4, 2021 the Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination interim final rule with comment period (IFC) was released.  It is slated to be published in the Federal Register on November 5, 2021, and this is the effective date of the mandate. Comments are due January 4, 2022.

This interim final rule with comment period revises the requirements that most Medicare- and Medicaid-certified providers and suppliers must meet to participate in the Medicare and Medicaid programs by establishing COVID-19 vaccination requirements for staff at Medicare- and Medicaid certified providers and suppliers.  The IFC directly applies only to the Medicare- and Medicaid-certified providers and suppliers listed in the IFC, which does include home health agencies and hospices, among others. It does not directly apply to other health care entities, such as physician offices or private duty agencies, that are not regulated by CMS. Most states have separate licensing requirements for health care staff and health care providers that would be applicable to physician office staff and other staff in small health care entities that are not subject to vaccination requirements under this IFC. Entities not covered by this rule may still be subject to other State or Federal COVID-19 vaccination requirements, such as those also issued today  by the Occupational Safety and Health Administration (OSHA) for certain employers.

Complementary to the OSHA ETS, this IFC requires certain providers and suppliers participating in Medicare and Medicaid programs to ensure staff are fully vaccinated for COVID-19, unless exempt.  CMS stated this is because vaccination of staff is necessary for the health and safety of individuals to whom care and services are furnished. Health care staff are at high risk for SARS-CoV-2 exposure, the virus that causes COVID-19, due to interactions with patients and individuals in the community. According to CMS those receiving a complete primary vaccination series reduce the risk of COVID-19 by 90 percent or more, thereby inhibiting the spread of disease to others. CMS further stated that a COVID-19 vaccination requirement reduces the likelihood of medical removal of health care staff from the workplace, as required by the OSHA COVID-19 Healthcare Emergency Temporary Standard (ETS).

This IFC adds regulations under the Infection Control conditions of participation for home health agencies and hospices. The regulations included in Phase 1 must be implemented by December 5, 2021 (30 days after publication of the IFC in the Federal Register). Phase 1 includes the requirement that staff receive the first dose, or only dose as applicable, of a COVID-19 vaccine, or have requested or been granted an exemption to the vaccination requirements of this IFC.  Phase 1 also includes the requirements for facilities to have appropriate policies and procedures developed and implemented.

Regulations included in Phase 2 must be implemented by January 4, 2022 (60 days after publication of the IFC in the Federal Register). Phase 2 requires that the primary vaccination series has been completed and that staff are fully vaccinated, except for those staff who have been granted exemptions, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by CDC, due to clinical precautions and considerations.  Staff who have completed a primary vaccination series by this date are considered to have met these requirements, even if they have not yet completed the 14-day waiting period required for full vaccination.

Although this IFC is being issued in response to the Public Health Emergency (PHE) for COVID-19, CMS expects it to remain relevant for some time beyond the end of the formal PHE. Depending on the future nature of the COVID-19 pandemic, CMS may retain these provisions as a permanent requirement for facilities, regardless of whether the Secretary continues the ongoing PHE declarations. Therefore, this rulemaking’s effectiveness is not associated with or tied to the PHE declarations, nor is there a sunset clause. Medicare interim final rules expire 3 years after issuance unless finalized. CMS stated that it expects to make a determination based on public comments, incidence, disease outcomes, and other factors regarding whether it will be necessary to conduct final rulemaking and make this rule permanent.

STAFF SUBJECT TO COVID-19 VACCINATION REQUIREMENTS

The provisions of this IFC require applicable providers and suppliers to develop and implement policies and procedures under which all staff are vaccinated for COVID-19. Each facility’s COVID-19 vaccination policies and procedures must apply to the following facility staff, regardless of clinical responsibility or patient contact and including all current staff as well as any new staff, who provide any care, treatment, or other services for the facility and/or its patients:

  • facility employees;
  • licensed practitioners;
  • students, trainees, and volunteers;
  • individuals who provide care, treatment, or other services for the facility and/or its patients, under contract or other arrangement.

These requirements are not limited to those staff who perform their duties within a formal clinical setting, as many health care staff routinely care for patients and clients outside of such facilities, such as home health, home infusion therapy, hospice, PACE programs, and therapy staff. There may be staff that primarily provide services remotely via telework that occasionally encounter fellow staff, such as in an administrative office or at an off-site staff meeting, who will themselves enter a health care facility or site of care for their job responsibilities. CMS is requiring vaccination for all staff that interact with other staff, patients, residents, clients, or PACE program participants in any location, beyond those that physically enter facilities, clinics, homes, or other sites of care. Individuals who provide services 100 percent remotely, such as fully remote telehealth or payroll services, are not subject to the vaccination requirements of this IFC.

CMS stated that it is overly burdensome to mandate that each provider and supplier ensure COVID-19 vaccination for all individuals who enter the facility. However, while facilities are not required to ensure vaccination of every individual, they may choose to extend COVID-19 vaccination requirements beyond those persons considered to be staff as defined in this rulemaking.

REMOTE WORKERS:

Facilities that employ or contract for services by staff who telework full-time (that is, 100 percent of their time is remote from sites of patient care, and remote from staff who do work at sites of care) should identify and monitor these individuals as a part of implementing the policies and procedures of this IFC, documenting and tracking overall vaccination status, but those individuals need not be subject to the vaccination requirements of this IFC. Note, however, that these individuals may be subject to other Federal requirements for COVID-19 vaccination.

INFREQUENT WORKERS:

Many infrequent services and tasks performed in or for a health care facility are conducted by “one off” vendors, volunteers, and professionals. Providers and suppliers are not required to ensure the vaccination of individuals who infrequently provide ad hoc non-health care services (such as annual elevator inspection), or services that are performed exclusively off-site, not at or adjacent to any site of patient care (such as accounting services), but they may choose to extend COVID-19 vaccination requirements to them if feasible. Other individuals who may infrequently enter a facility or site of care for specific limited purposes and for a limited amount of time, but do not provide services by contract or under arrangement, may include delivery and repair personnel.

WORKERS WHO DO NOT FALL INTO OTHER CATEGORIES:

When determining whether to require COVID-19 vaccination of an individual who does not fall into the categories established by this IFC, facilities should consider

  • frequency of presence,
  • services provided, and
  • proximity to patients and staff.

For example, a plumber who makes an emergency repair in an empty restroom or service area and correctly wears a mask for the entirety of the visit may not be an appropriate candidate for mandatory vaccination. On the other hand, a crew working on a construction project whose members use shared facilities (restrooms, cafeteria, break rooms) during their breaks would be subject to these requirements due to the fact that they are using the same common areas used by staff, patients, and visitors.

CMS strongly encourages facilities, when the opportunity exists and resources allow, to facilitate the vaccination of all individuals who provide services infrequently and are not otherwise subject to the requirements of this IFC.

DETERMINING WHEN STAFF ARE CONSIDERED “FULLY VACCINATED”

  • Consistent with CDC guidance, CMS considers staff fully vaccinated if it has been 2 or more weeks since they completed a primary vaccination series for COVID-19.
  • Completion of a primary vaccination series is defined as having received a single-dose vaccine or all doses of a multi-dose vaccine. Currently, CDC guidance does not include either the additional (third) dose of an mRNA COVID-19 vaccine for individuals with moderately or severely immunosuppression or the booster dose for certain individuals who received the Pfizer-BioNTech Vaccine in their definition of fully vaccinated. Therefore, for purposes of this IFC, neither additional (third) doses nor booster doses are required. The OSHA ETS also defines fully vaccinated in accordance with CDC guidance. Hence, definitions of fully vaccinated are consistent among the requirements in these regulations.

For purposes of this IFC, and if permitted or recommended by CDC, COVID-19 vaccine doses from different manufacturers may be combined to meet the requirements for a primary vaccination series.

Providers and suppliers must have a process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC.

The majority of staff will likely receive a COVID-19 vaccine authorized for emergency use by the FDA or licensed by the FDA. Currently, this would include the authorized Pfizer-BioNTech (interchangeable with the licensed Comirnaty vaccine made by Pfizer for BioNTech), Moderna, and Janssen (Johnson & Johnson) COVID-19 vaccines. It is also expected that vaccine administration will likely occur within the U.S. for the majority of staff. However, some staff may receive FDA approved or authorized COVID-19 vaccines outside of the U.S., vaccines administered outside of the U.S. that are listed by the World Health Organization (WHO) for emergency use that are not approved or authorized by the FDA, or vaccines during their participation in a clinical trial at a site in the U.S. For these staff, CMS defers to CDC guidance for COVID-19 vaccination. For more information, providers and suppliers should consult the CDC website at https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19- vaccines-us.html#.

Providers should note the following additional guidance regarding vaccines.

  • Repeat vaccine doses are not recommended by CDC for individuals who previously completed the primary series of a vaccine approved or authorized by the FDA, even if administration of the vaccine occurred outside of the U.S.
  • Individuals who receive a COVID-19 vaccine for which two doses are required to complete the primary vaccination series should adhere as closely as possible to the recommended intervals. Following completion of their second dose, certain individuals who had received the Pfizer-BioNTech COVID-19 vaccine may receive a booster dose at least 6 months after completion of the primary vaccination series. Moderately to severely immunocompromised individuals who have received 2 doses of an mRNA vaccine may receive a third dose at least 28 days after the second dose. Vaccine administration may occur inside or outside of the U.S. The WHO maintains a list of COVID-19 vaccines for emergency use.
  • The CDC advises that doses of an FDA-approved or authorized COVID-19 vaccine are not recommended for individuals who have previously completed the primary series of a vaccine listed for emergency use by the WHO.
  • For those who have not completed the primary series of a vaccine listed for emergency use by the WHO, they may receive an FDA approved or authorized COVID-19 vaccination series.
  • Individuals who have received a COVID-19 vaccine that is neither approved nor authorized by the FDA, nor listed on the WHO emergency use list, may receive an FDA approved or authorized vaccination series. The CDC guidelines recommend at least 28 days between administration of an FDA licensed or authorized vaccine, a non-FDA approved or authorized vaccine, and a vaccine listed by WHO for emergency use.
  • For the completion of the primary series of COVID-19 vaccination, individuals should generally avoid using heterologous vaccines—meaning receiving doses of different vaccines—to complete a primary COVID-19 vaccination series. Nevertheless, CDC does recognize that, in certain situations (for example, when the vaccine product given for the first dose cannot be determined or is no longer available), a different vaccine may be used to complete the primary COVID-19 vaccination series. Accordingly, staff may be considered compliant with the requirements within this regulation if they have received any combination of two doses of a vaccine licensed or authorized by the FDA or listed on the WHO emergency use list as part of a two-dose series. Of note, the recommended interval between the first and second doses of a vaccine licensed or authorized by FDA, or listed on the WHO emergency use list, varies by vaccine type. For interpretation of vaccination records and compliance with this rule, people who received a heterologous primary series (with any combination of FDA-authorized, FDA-approved, or WHO EUL-listed products) can be considered fully vaccinated if the second dose in a two dose heterologous series must have been received no earlier than 17 days (21 days with a 4-day grace period) after the first dose.
  • Some staff may receive COVID-19 vaccines due to their participation in a clinical trial at a site in the U.S. Repeat vaccine doses are not recommended by CDC for participants in a clinical trial who previously completed the primary series of a vaccine approved or authorized by FDA, or listed for emergency use by the WHO. Likewise, for individuals who participated in a clinical trial at a site in the U.S. and received the full series of an “active” vaccine candidate (not placebo) and “vaccine efficacy has been independently confirmed (for example, by a data and safety monitoring board),” CDC does not recommend repeat doses.
  • Because the science and clinical recommendations are evolving rapidly, we refer individuals to CDC’s Interim Public Health Recommendations for Fully Vaccinated People for additional details.

DOCUMENTATION OF STAFF VACCINATIONS

Providers must track and securely document the vaccination status of each staff member, including those for whom there is a temporary delay in vaccination, such as recent receipt of monoclonal antibodies or convalescent plasma. Vaccine exemption requests and outcomes must also be documented. This documentation will be an ongoing process as new staff are onboarded.

Examples of appropriate places for vaccine documentation include a facility’s immunization record, health information files, or other relevant documents. All medical records, including vaccine documentation, must be kept confidential and stored separately from an employer’s personnel files, pursuant to ADA and the Rehabilitation Act.

Examples of acceptable forms of proof of vaccination include:

  • CDC COVID-19 vaccination record card (or a legible photo of the card),
  • Documentation of vaccination from a health care provider or electronic health record, or
  • State immunization information system record.
  • If vaccinated outside of the U.S., a reasonable equivalent of any of the previous examples would suffice.

Providers and suppliers have the flexibility to use the appropriate tracking tools of their choice. For those who would like to use it, CDC provides a staff vaccination tracking tool that is available on the NHSN website. This is a generic Excel-based tool available for free to anyone, not just NHSN participants, that facilities can use to track COVID-19 vaccinations for staff members.

VACCINE EXEMPTIONS

Providers must establish and implement a process by which staff may request an exemption from COVID-19 vaccination requirements based on an applicable Federal law. Certain allergies, recognized medical conditions, or religious beliefs, observances, or practices, may provide grounds for exemption. Facilities should refer to the CDC informational document, Summary Document for Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States.

Providers must comply with applicable Federal anti-discrimination laws and civil rights protections. Applicable laws include:

  • Americans with Disabilities Act (ADA);
  • Section 504 of the Rehabilitation Act (RA);
  • Title VII of the Civil Rights Act of 1964;
  • Pregnancy Discrimination Act; and
  • Genetic Information Nondiscrimination Act

In addition, other Federal laws may provide employees with additional protections.  Employers following CDC guidelines and the new requirements in this IFC may also be required to provide appropriate accommodations, to the extent required by Federal law, for employees who request and receive exemption from vaccination because of a disability, medical condition, or sincerely held religious belief, practice, or observance.  For more information about these situations, employers can consult the Equal Employment Opportunity Commission’s (EEOC) website. CMS also directs providers and suppliers to the EEOC Compliance Manual on Religious Discrimination for information on evaluating and responding to such requests. While employers have the flexibility to establish their own processes and procedures, including forms, there is The Safer Federal Workforce Task Force’s “request for a religious exception to the COVID-19 vaccination requirement” template as an example.

Requests for exemptions based on an applicable Federal law must be documented and evaluated in accordance with applicable Federal law and each facility’s policies and procedures. As is relevant here, this IFC preempts the applicability of any State or local law providing for exemptions to the extent such law provides broader exemptions than provided for by Federal law and are inconsistent with this IFC.

For staff members who request a medical exemption from vaccination, all documentation confirming recognized clinical contraindications to COVID-19 vaccines, and which supports the staff member’s request, must be signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws. Such documentation must contain all information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and a statement by the authenticating practitioner recommending that the staff member be exempted from the facility’s COVID-19 vaccination requirements based on the recognized clinical contraindications.

INFECTION PREVENTION AND CONTROL

All applicable providers and suppliers must have a process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19.  Those Medicare- and Medicaid- certified providers and suppliers not already having to follow specific infection prevention and control requirements, such as Home Infusion Therapy (HIT) suppliers, must have a process for ensuring that they follow nationally recognized infection prevention and control guidelines intended to mitigate the transmission and spread of COVID-19. This process must include the implementation of additional precautions for all staff who are not fully vaccinated for COVID-19.

PLANNING

Providers must make contingency plans in consideration of staff that are not fully vaccinated to ensure that they will soon be vaccinated and will not provide care, treatment, or other services for the provider or its patients until such time as such staff have completed the primary vaccination series for COVID-19 and are considered fully vaccinated, or, at a minimum, have received a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID19 vaccine. This planning should also address the safe provision of services by individuals who have requested an exemption from vaccination while their request is being considered and by those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations.

Contingency planning may extend beyond the specific requirements of this rule to address topics such as staffing agencies that can supply vaccinated staff if some of the facility’s staff are unable to work. Contingency plans might also address special precautions to be taken when, for example, there is a regional or local emergency declaration, such as for a hurricane or flooding, which necessitates the temporary utilization of unvaccinated staff, in order to assure the safety of patients.

ENFORCEMENT

CMS stated that it will issue interpretive guidelines, which include survey procedures, following publication of this IFC. Along with this, CMS will advise and train State surveyors on how to assess compliance with the new requirements among providers and suppliers.  Providers and suppliers that are cited for noncompliance may be subject to enforcement remedies imposed by CMS depending on the level of noncompliance and the remedies available under Federal law (for example, civil money penalties, denial of payment for new admissions, or termination of the Medicare/Medicaid provider agreement).

The conditions of participation for hospices at § 418.60, Infection Control, would be modified to include the additions below.

Infection control

(d) Standard: COVID-19 Vaccination of facility staff. The hospice must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, 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.

(1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following hospice staff, who provide any care, treatment, or other services for the hospice and/or its patients:

(i) Hospice employees;

(ii) Licensed practitioners;

(iii) Students, trainees, and volunteers; and

(iv) Individuals who provide care, treatment, or other services for the hospice and/or its patients, under contract or by other arrangement.

(2) The policies and procedures of this section do not apply to the following hospice staff:

(i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where hospice services are provided to patients and who do not have any direct contact with patients, patient families and caregivers, and other staff specified in paragraph (d)(1) of this section; and

(ii) Staff who provide support services for the hospice that are performed exclusively outside of the settings where hospice services are provided to patients and who do not have any direct contact with patients, patient families and caregivers, and other staff specified in paragraph (d)(1) of this section.

(3) The policies and procedures must include, at a minimum, the following components:

(i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the hospice and/or its patients;

(ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations;

(iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19;

(iv) A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (d)(1) of this section;

(v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC;

(vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law;

(vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the hospice has granted, an exemption from the staff COVID-19 vaccination requirements;

(viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains:

(A) All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and

(B) A statement by the authenticating practitioner recommending that the staff member be exempted from the hospice’s COVID-19 vaccination requirements for staff based on the recognized clinical contraindications;

(ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and

(x) Contingency plans for staff who are not fully vaccinated for COVID-19.

The conditions of participation for home health agencies at § 484.70, Infection Prevention & Control, would be modified to include the additions below.

(d) Standard: COVID-19 Vaccination of Home Health Agency staff. The home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, 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 multidose vaccine.

(1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following HHA staff, who provide any care, treatment, or other services for the HHA and/or its patients:

(i) HHA employees;

(ii) Licensed practitioners;

(iii) Students, trainees, and volunteers; and (iv) Individuals who provide care, treatment, or other services for the HHA and/or its patients, under contract or by other arrangement.

(2) The policies and procedures of this section do not apply to the following HHA staff:

(i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section; and

(ii) Staff who provide support services for the HHA that are performed exclusively outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section.

(3) The policies and procedures must include, at a minimum, the following components:

(i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the HHA and/or its patients;

(ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations;

(iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19;

(iv) A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (d)(1) of this section;

(v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC;

(vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law; (

vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the HHA has granted, an exemption from the staff COVID-19 vaccination requirements;

(viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains

(A) All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and

(B) A statement by the authenticating practitioner recommending that the staff member be exempted from the HHA’s COVID-19 vaccination requirements for staff based on the recognized clinical contraindications;

(ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and

(x) Contingency plans for staff who are not fully vaccinated for COVID-19.