COVID-19 Vaccination of facility staff. The facility 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.
§483.80(i)(1) Regardless of clinical responsibility or resident contact, the policies and procedures must apply to the following facility staff, who provide any care, treatment, or other services for the facility and/or its residents:
(i) Facility employees;
(ii) Licensed practitioners;
(iii) Students, trainees, and volunteers; and
(iv) Individuals who provide care, treatment, or other services for the facility and/or its residents, under contract or by other arrangement.
§483.80(i)(2) The policies and procedures of this section do not apply to the following facility staff:
(i) Staff 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 specified in paragraph (i)(1) of this section; and
(ii) Staff who provide support services for the facility that are performed exclusively outside of the facility setting and who do not have any direct contact with residents and other staff specified in paragraph (i)(1) of this section.
§483.80(i)(3) The policies and procedures must include, at a minimum, the following components:
(i) A process for ensuring all staff specified in paragraph (i)(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 facility and/or its residents;
(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 (i)(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 facility 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 facility'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.
Effective 60 Days After Publication:
§483.80(i)(3)(ii) A process for ensuring that all staff specified in paragraph (i)(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;
Based on a review of the DEPARTMENT OF HEALTH & HUMAN SERVICES QSO 22-07-ALL memo dated December 28, 2021, select facility policy, staff observations and interviews, it was determined that the facility failed to fully develop and follow their policy for COVID-19 vaccination for staff.
A review of a DEPARTMENT OF HEALTH & HUMAN SERVICES, Center for Clinical Standards and Quality/Quality, Safety & Oversight Group dated December 28, 2021, QSO 22-07-ALL memo stated that:
Within 60 days after the issuance of this memorandum 4, if the facility demonstrates that:
Policies and procedures are developed and implemented for ensuring all facility staff, regardless of clinical responsibility or patient or resident contact are vaccinated for COVID-19; and 100% of staff have received the necessary doses to complete the vaccine series (i.e., one dose of a single-dose vaccine or all doses of a multiple-dose vaccine series), or have been granted a qualifying exemption, or identified as having a temporary delay as recommended by the CDC, the facility is compliant under the rule; or Less than 100% of all staff have received at least one dose of a single-dose vaccine, or all doses of a multiple-dose vaccine series, or have been granted a qualifying exemption, or identified as having a temporary delay as recommended by the CDC, the facility is noncompliant.
A review of the facility policy entitled "COVID-19 Vaccine Policies and Procedures", last reviewed/revised on February 1, 2022, indicated the purpose is to establish the process to comply with the Federal mandate that all staff are vaccinated against COVID - 19 unless they have a medical or religious exemption to help reduce the risk residents and staff have of contracting and spreading COVID -19. Additional precautions and contingency plans for unvaccinated staff: staff who receive an exemption to the COVID - 19 vaccine will be subject to additional precautions to mitigate the transmission and spread of COVID - 19, which includes: routine surveillance testing , in accordance with state, federal and / or CDC guidelines (testing twice a week), Personal protective equipment, as recommended by state, federal guidelines and or CDC guidelines (N95), assigned to work with fully vaccinated residents when possible. Any employee who has not been vaccinated in accordance with the facility COVID vaccination policy or as not submitted an acceptable exemption form will be terminated.
There was no documented evidence, at the time of the review during the survey of May 25, 2022, that the facility's policy for COVID-19 Vaccine Policies and Procedures included specific protocols defining the the personal protective equipment that is to be worn by by unvaccinated staff with qualifying exemptions, when it is required and the locations within the facility. There was no documented evidence, at the time of the review, on May 25, 2022, that the facility's policy specified when and where an "N95", is to be worn by unvaccinated staff.
Interview on May 25, 2022, at approximately 3:30 PM, with Employee 1, Licensed Practical Nurse (LPN), on the ground floor, indicated that she was granted a non-medical exemption. She was observed during this interview to be wearing a surgical mask, as confirmed by Employee 1.
At the time of the survey ending May 25, 2022, the facility had one (1) resident test positive for COVID 19, who tested positive during routine testing, and who was not hospitalized and or expired, in the past 4 weeks.
Review of National Healthcare Safety Network (NHSN) date for week ending May 15, 2022, revealed that the facility had 86.6 % of staff fully vaccinated.
Review of the facility provided, employee vaccination status - matrix, at the time survey ending May 25, 2022, revealed that 351 staff were fully vaccinated, with 2 partially vaccinated (new hire), and 53 granted exemptions, totaling 100% staff vaccination rate.
Interview with the Nursing Home Administrator (NHA) on May 25, 2022, at approximately 3:00 PM, confirmed that the facility's policy regarding COVID-19 vaccinations (additional precautions and contingency plans for unvaccinated staff) lacked specific mitigation procedures as stated above and failed to define when and where unvaccinated staff are required to wear N95 or additional PPE.
28 Pa. Code 201.14 (a) Responsibility of Licensee
28 Pa. Code 201.18(b)(1)(d)(e)(1) Management
| ||Plan of Correction - To be completed: 06/30/2022|
1. The facility's COVID 19 policy regarding COVID-19 will be updated with when and where unvaccinated staff are required to wear an N95 or additional PPE. Employee 1 will be educated on the updated policy.
2. The facility will conduct an initial audit to verify unvaccinated staff are wearing appropriate PPE.
3. The DON/designee will educate unvaccinated staff on the updated COVID policy including the appropriate PPE.
4. The facility will conduct an audit weekly x4 weeks and monthly x2 months to verify unvaccinated staff are wearing the appropriate PPE. Results will be reviewed at QAPI.