(a) Standard procedures. The PACE organization must follow accepted policies and standard procedures with respect to infection control, including at least the standard precautions developed by the Centers for Disease Control and Prevention.
(b) Infection control plan. The PACE organization must establish, implement, and maintain a documented infection control plan that meets the following requirements:
(1) Ensures a safe and sanitary environment.
(2) Prevents and controls the transmission of disease and infection.
(c) Contents of infection control plan. The infection control plan must include, but is not limited to, the following:
(1) Procedures to identify, investigate, control, and prevent infections in every Pace center and in each participant's place of residence.
(2) Procedures to record any incidents of infection.
(3) Procedures to analyze the incidents of infection to identify trends and develop corrective actions related to the reduction of future incidents.
(d) COVID-19 Vaccination of PACE organization staff. The PACE organization 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 participant contact, the policies and procedures must apply to the following PACE organization staff, who provide any care, treatment, or other services for the PACE organization and/or its participants:
(i) PACE organization employees;
(ii) Licensed practitioners providing services on behalf of the PACE organization;
(iii) Students, trainees, and volunteers providing services on behalf of the PACE organization; and
(iv) Individuals who provide care, treatment, or other services on behalf of the PACE organization, under contract or by other arrangement.
(2) The policies and procedures of this section do not apply to the following PACE organization staff:
(i) Staff who exclusively provide telehealth or telemedicine services for the PACE organization and/or its participants and who do not have any direct contact with participants and other PACE organization staff specified in paragraph (d)(1) of this section; and
(ii) Staff who provide support services for the PACE organization and/or its participants and who do not have any direct contact with participants and other PACE organization 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 PACE organization and/or its participants;
(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 PACE organization has granted, an exemption from the staff COVID-19 vaccination requirements based on recognized clinical contraindications or applicable Federal laws;
(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 PACE organization'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.
[64 FR 66279, Nov. 24, 1999, as amended at 71 FR 71334, Dec. 8, 2006; 86 FR 61618, Nov. 5, 2021]