HospitalInspections.org

Based on a review of the facility's employee vaccination spreadsheet, interviews with staff, review of a policy and procedure, request for religious exemptions, and review of emails between facility staff and Patient Care Technicians (PCT) FF, it was determined that the facility failed to ensure that two employees (PCT FF and PCT GG) out of a sampled 17 employees did not provide direct patient care and treatment since neither had received the first dose of the primary vaccination series for a multi-dose COVID vaccine, received a single-dose of the COVID vaccine, or completion of a medical or religious exemption. In addition, the facility failed to efficiently track and secure documentation on the vaccination status of 17 sampled employees.

Findings:

Cross refer to A-0792 as it relates to the facility's failure to ensure staff had received a first dose of the primary vaccination series for a multi-dose COVID vaccine, received a single-dose of the COVID vaccine, or had completed a vaccination exemption prior to providing patient care or treatment within the facility.

Based on a review of the facility's employee vaccination spreadsheet, interviews with staff, review of a policy and procedure, request for religious exemptions, and review of emails between facility staff and Patient Care Technician (PCT) FF, it was determined that the facility failed to ensure that two employees (PCT FF and PCT GG) out of a sampled 17 employees did not provide direct patient care and treatment since neither had received the first dose of the primary vaccination series for a multi-dose COVID vaccine, received a single-dose of the COVID vaccine, or completion of a medical or religious exemption. In addition, the facility failed to efficiently and effectively track and secure documentation on the vaccination status of the 17 sampled employees.

Findings:

A review of the facility's employee vaccination spreadsheet revealed that 15 employees 'vaccination statuses were marked as 'action needed.' In addition, two employees were marked 'declined.' Continued review revealed that not one of the 17 employees had a 'first dose' date noted in the column for the COVID vaccine.

An interview was conducted with the Director of Quality (DOQ) DD on 4/19/22 at 1:30 p.m. in the facility's conference room. DOQ DD stated that he had been the Director of Quality for a little over a year. DOQ DD explained he was responsible for tracking employee COVID vaccination or exemption status. He said that he tracked the data using an employee vaccination status spreadsheet, and the spreadsheet was updated weekly. DOQ DD said that CEO CC provided oversight. An observation of the tracking spreadsheet revealed seventeen employees with vaccination status of 'action required' or 'declined.' DOQ DD explained that this status meant that employees could have had a declaration form filled out when COVID-19 first emerged but had not completed a religious or medical exemption, employees may have had one dose of the COVID-19 vaccine but had not received the second dose, employees may have signed a religious or medical exemption but had not signed a mitigation statement, or the employee had not turned in a medical or religious exemption. DOQ DD explained that the employee would have a date in the 'first dose' column if the employee had started the vaccination process. DOQ DD explained that once he received an employee religious exemption, he would forward the form to Human Resources (HR) for approval. Once HR approved the form, he would add the information to the employee vaccination status spreadsheet. The employee would be notified of the approval, and the employee would be asked to sign a Risk Mitigation Form. DOQ DD said that there was no allotted timeframe established from when he received a religious/medical exemption and the time he would send the form to HR. In addition, there was no established time that HR needed to follow to return the form to DOQ DD. He also stated there was no time frame for the employee to sign the mitigation form once the religious or medical exemption had been approved. Additionally, DOQ DD said that there was no procedure to document the date of approval for the religious or medical exemption forms.

A review of an email dated 12/2/21 revealed that a facility staff member emailed PCT FF informing PCT FF that whether she worked in direct patient care or not, PCT FF would need to provide COVID-19 vaccination status or a religious or medical exemption to the facility no later than 12/5/21.

A review of an email dated 2/7/22 revealed that a facility staff member emailed PCT FF informing PCT FF that the facility had not received a COVID-19 vaccination status or a religious or medical exemption. The facility informed PCT FF that the deadline to turn in one of these items was 2/13/22.

DOQ DD revealed that the last date that PCT FF worked was 4/1/22. PCT FF provided direct-patient care. DOQ DD stated that PCT FF turned in a signed religious exemption on 4/19/22, but it had not yet gone through the approval process.

A review of a 'Request for Religious Exemption to the COVID-19 Vaccination Requirement', dated 4/19/22, revealed that this was the second request that PCT FF had turned in.

DOQ DD stated that the last date that PCT GG worked was 4/18/22. PCT GG provided direct patient care. During the investigation survey, DOQ DD found a signed religious exemption form from PCT GG dated 2/14/22. DOQ DD stated it must have gotten overlooked. PCT GG's religious exemption had not been processed for approval at the time of the interview, 4/19/22 at 1:30 p.m.

During an interview with the Chief Executive Officer (CEO) CC on 4/19/22 at 2:40 p.m. in the conference room, CEO CC stated that the Risk Manager provided oversight and tracked the staff vaccination status at the facility. CEO CC explained that he expected the facility staff to be at 100% percent, or close to 100% of the vaccination mandate. However, he added that all staff should be vaccinated or exempted from vaccination. CEO CC stated that the staff vaccination data were reported and discussed during the monthly Human Resource (HR) meetings and Quality meetings. CEO CC indicated he learned today that the facility had two PCTs (PCT FF and PCT GG) who worked shifts within the last couple of days that were neither vaccinated nor exempted from vaccination. He acknowledged that neither of the PCTs should have been on the schedule based on their vaccination/exemption status.

A review of the facility's policy entitled, "Mandatory Covid-19 Vaccination," Policy #IC.41, last reviewed 3/2022 revealed that the purpose of the policy was to comply with the Center for Medicare Services (CMS) interim final rule mandating COVID-19 vaccination for healthcare workers. The organizational-wide policy applied to facility employees, licensed practitioners, students, trainees, volunteers, and individuals who provided care, treatment, or other services for the facility and/or patients under contract or another arrangement. It applied to these individuals regardless of clinical responsibility or patient contact, providing any type of care, treatment, or other services for the organization or its patients.

Definitions:

Fully vaccinated meant that it had been two weeks or more since an individual had completed a primary series for COVID-19.

Primary vaccination series for COVID-19 meant the administration of a single dose vaccine or the administration of all required doses of a multi-dose vaccine.

Good Faith Effort meant that the organization had taken aggressive steps toward achieving compliance with staff vaccination requirements and/or the provider had no or had limited access to the vaccine and had documented attempts to access the vaccine.

Medical Exemption meant an individual was not required to be vaccinated due to an allergic and/or recognized clinical contraindication to COVID-19 vaccines.

Religious Exemption meant an individual was not required to be vaccinated due to religious beliefs or practices in accordance with ADA, Section 504 of the Rehabilitation Act, Section 1557 of the Accountable Care Act, and Title VII of the Civil Rights Act.

The organization would make a good faith effort to assure that by January 27, 2022, all applicable individuals would have in place their exemption status and or receive, at a minimum, a single dose COVID-19 vaccine or the first dose of a primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the organization and/or its patients.

The facility would follow and enforce the deadlines for the COVID-19 vaccination process put in place by CMS.

Individuals who requested an exemption from COVID-19 vaccination requirements based on medical contraindications or conflict with religious beliefs, observances, or practices would submit their request to the Human Resources (HR) Department on an organization-approved or comparable form. If a religious exemption were denied for any reason, the employee would be notified immediately by the employee health nurse.

All individuals who were either exempted from vaccination or were not fully vaccinated would complete an Individual Risk Mitigation Plan provided to the individual by an employee health nurse.

The organization would track and securely document the vaccination status of each individual, including those for who there was a temporary delay in vaccination, such as recent monoclonal antibodies or convalescent plasma. Vaccine exemption requests and outcomes would also be documented.

While no specific tool was mandated, records would contain the following information, as applicable, for each individual:
1. First and last name
2. Medical or religious exemption granted- date
3. Declined COVID vaccine- date
4. Vaccinated with dose one- date administered and vaccine manufacture name
5. Vaccinated with dose two- date administered and vaccine manufacture name
6. Was vaccination series completed - yes or no
7. Booster administered- yes or no
* Additional booster dose vaccinated date
* Additional booster dose manufacture
8. Employee or non-employee

Individuals who had indicated that they would not get vaccinated and did not qualify for an exemption would not be permitted to engage in work-related activities. For organizational employees, the individual may be placed off work without pay. If necessary, the organization would actively seek replacement staff or obtain temporary vaccinated staff until permanent vaccinated replacements could be found.