§483.80(i) 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;
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Observations:
Based on a review of select facility policy, the Centers for Medicare and Medicaid directives, employee vaccine data, and staff interviews, it was determined that the facility failed to fully develop implement policies and procedures to ensure that all staff were vaccinated for COVID-19. The facility's staff vaccination rate was 97.8% at the time of the survey on June 10, 2022.
Findings include:
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 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 a facility policy for "Covid -19 Vaccine Policy for Healthcare Personnel", revised January 21, 2022 and last reviewed June 1, 2022, revealed that the facility's policy would 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.
According to the facility policy staff refers to any individuals that work or volunteer in the facility, regardless of clinical responsibility or resident contact. This includes individuals who may not be physically in the LTC (long term care) facility for a period (e.g., illness, disability, or scheduled time of), but are expected to return to work.
The policy indicated that all facility staff are required to have received at least one dose of an FDA-authorized COVID-19 vaccine by January 27, 2022, and the final dose of a primary vaccination series by February 28, 2022. New hires will be subject to the same requirements as current staff and must have received, at a minimum, the first dose of a two-dose COVID-19 vaccine or a one-dose COVID-19 vaccine by the regulatory deadline or prior to providing any care, treatment, or other services for the facility and/or its patients.
When reviewed during the survey of June 10, 2022, the facility's policy failed to identify timeframes for partially vaccinated staff (deadlines for partially vaccinated newly hired staff) and/or further steps that will be taken should a staff member fail to become fully vaccinated.
A review of the facility staff vaccination data revealed that Employee 1, a nurse aide, was only partially vaccinated at the time of the survey of June 10, 2022. Further review of the employee's vaccination status revealed that Employee 1 received her first dose of a two dose series of the COVID-19 vaccine on April 27, 2022. However, as of the time of the survey ending June 10, 2022, Employee 1 had not received her second dose of the 2-dose COVID-19 vaccination series. As a result, the facility's staff vaccination rate was 97.8%.
A review of the facility staff vaccination data revealed that Employee 2, a temporary nurse aide, was only partially vaccinated at the time of the survey of June 10, 2022. Further review of the employee's vaccination status revealed that Employee 2 received her first dose of a two dose series of the COVID-19 vaccine on April 27, 2022. However, as of the time of the survey ending June 10, 2022, Employee 1 had not received her second dose of the 2-dose COVID-19 vaccination series. As a result, the facility's staff vaccination rate was 97.8%.
A review of NHSN reported data dated May 29, 2022, revealed that the facility COVID-19 staff vaccination percentage rate was 91.5 %.
At the time of the end of survey on June 10, 2022, the facility policy and procedures for staff COVID-19 vaccinations had not been fully developed or implemented.
Interview with the Director of Nursing on June 10, 2022, at 2:00 PM confirmed that the facility did not fully develop and implement a COVID-19 vaccination policy to include timeframes for newly hired partially vaccinated staff to receive all doses of their vaccination series. The facility confirmed that the current staff vaccination rate was less than 100%.
28 Pa. Code 201.14 (a) Responsibility of Licensee
28 Pa. Code 201.18(b)(1)(d)(e)(1) Management
28 Pa. Code 211.12 (c) Nursing Services
| | Plan of Correction - To be completed: 08/01/2022
F888 COVID 19 Vaccination of Facility Staff The preparation, submission and implementation of this Plan of Correction does not constitute an admission of or agreement with the facts and conclusions set forth on this survey report. The Plan of correction is prepared and executed to continuously improve the quality of care and to comply with all applicable federal and state regulatory requirements. 1. Employee 1 and Employee 2 have received their second dose at local pharmacies. 2. An audit of new hires in the last 30 days will be completed by HR/ designee to ensure the new employee has received the first dose of the covid vaccine or has completed and acceptable exemption.
3. Education to HR and staffing director on the COVID vaccine policy.
4. An audit of new hires will be completed by HR/designee to ensure compliance with the covid 19 policy monthly x 3. Results of the audit will be reviewed at QAPI to ensure compliance.
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