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 facility policy, standards established by the Centers for Medicare and Medicaid Services, as well as employee vaccination data and staff interviews, it was determined that the facility failed to implement policies and procedures to ensure that all staff were vaccinated for COVID-19.
The facility's policy entitled "CMS Vaccine Mandate-COVID-19 addendum," undated, revealed that effective February 26, 2022, all individuals must receive one dose of a single vaccine or all doses of multidose vaccine series (fully vaccinated), or have been granted an exemption, or have been identified as appropriate for a temporary delay per the CDC guidance.
According to the CMS Memorandum QSO-22-07-ALL, dated December 28, 2021, CMS published an Interim Final Rule, entitled "Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination." It indicated that within 60 days after the issuance of the memorandum, if the facility demonstrated that less than 100 percent of all staff had 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 was noncompliant under the rule.
At the time of the survey start date March 21, 2022, the facility did not meet the requirement of staff being fully vaccinated, being granted an exemption, or being identified as appropriate for a temporary delay per the CDC guidance.
Review of facility's employee vaccination status information revealed that as of March 21, 2022, the vaccination rate of employees who were fully vaccinated was 71.2 percent.
The facility failed to provide evidence that Nurse Aides 5, 6 and 7; Registered Nurse 8; and Licensed Practical Nurse 9 were fully vaccinated, had been granted a qualifying exemption, or were identified as having a temporary delay.
Interview with Special Projects Employee 10 on March 22, 2022, at 3:22 p.m. and March 24, 2022, at 8:30 a.m. confirmed that the employees who were listed were currently working at the facility, and that not all staff were vaccinated against the COVID-19 virus and/or had a medical or nonmedical exception approved as of March 22, 2022.
28 Pa. Code 201.14 (a) Responsibility of Licensee
28 Pa. Code 201.18(b)(1)(d)(e)(1) Management
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Nurse Aides 5, 6 and 7 as well as Registered Nurse 8 and Licensed Practical Nurse 9 were immediately notified by Human Resources, on 03/23/2022, that they were out of compliance with the CMS Memorandum dated December 28, 2021 and The Village at Morrisons Cove's Mandatory COVID-19 Vaccination Policy Addendum.
In accordance with the VMC's policy and timeline, these staff were given until Sunday, March 27, 2022 to produce proof of full vaccination, as defined by CMS Memorandum QSO-22-07-ALL, or submit and have approved a religious or medical exemption completed and signed by a licensed practitioner. Per VMC Mandatory COVID-19 Vaccination Policy, these staff were informed that if they did not comply by the given date, their employment with the VMC would cease at that time.
All employees were in compliance as of Thursday, 03/24/2022.
The Human Resource personnel, including the Special Projects Coordinator, HR Generalist, Intake Coordinator or designee will conduct weekly audits of the COVID-19 Mandatory Staff Vaccination spread sheet to monitor those employee who, per recommendation of the CDC, are temporarily delayed in receiving the vaccination.
The Special Projects Coordinator will orchestrate a facility wide education requirement including an depth explanation of The Village at Morrison's Cove's vaccination policy and CMS guidelines. This education will include in person discussions with each department manager and staff as well as vaccination handouts and additional copies of the updated policy with the addendum.
The Human Resource department will continue to update the staff vaccination spreadsheet, policy binder, vaccination card binder and exemption binder on a daily/weekly basis as needed. Audit findings, and compliance will be reported to the Quality Assurance Performance Improvement Committee monthly times three.