HospitalInspections.org

Based on interviews and document review, it was determined the facility staff failed to create and enact employee COVID-19 vaccination policies to meet the standard of this regulation. Specifically, the facility failed to have:

A process for tracking and securely documenting the COVID-19 vaccinations status of all staff to include contracted employees such as medical providers

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;

A process for tracking and securely documenting information provided by those staff who have requested, and for whom the hospital has granted, an exemption from the staff COVID-19 vaccination requirements;

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 hospital's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications

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

The findings include:

On 2/14/2022 through 2/5/2022, the surveyor reviewed the facility's COVID-19 staff vaccination documentation, the policy titled "Employee COVID-19 Vaccine Requirement Plan" effective September 30, 2021, and the policy titled "Exemption Procedure for COVID-19 Vaccine". The policies failed to contain a process for tracking and securely documenting the COVID-19 vaccinations status of all staff to include contracted employees such as medical providers.

The facility provided documentation tracking employees and some of the facility's contractors, but the policy failed to include the specific process for which it would track and securely document the COVID-19 vaccination status (including the position or role of the staff member), booster doses as recommended by the CDC, and exemptions (including type of exemption and supporting documentation) other than stating in the policy, "Record Keeping: Consistent with applicable privacy laws and regulations, the facility must maintain records of worker's vaccination or exemption status. if a worker is exempt, the facility then must also maintain records of the worker's testing results".

The facility failed to ensure documentation of 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 a statement by the authenticating practitioner recommending that the staff member be exempted from the hospital's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications. A review of one (1) completed medical exemption form and a sample blank form included with the facility's policy failed to contain the appropriate documentation as per the regulation.

The facility's policies failed to include 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.

On 2/15/2022, the facility failed to provide documentation/tracking of the vaccine status for all one-hundred (100) providers on the facility's contracted medical provider list. The surveyor sampled providers from the list and requested vaccination documentation for those providers. The facility provided the surveyor with the Virginia Department of Health's Vaccination Immunization Vaccination System (VIIS) vaccine documentation for the providers sampled and all were fully vaccinated. During an interview with Staff Member (SM) #2, SM #1 stated that all contractors have been vaccinated or have an exemption and the facility can obtain the vaccination information for those providers upon request, but the facility had not been maintaining and tracking the documentation in their own system. SM #2 stated that the facility will work on obtaining that documentation for all providers. SM #2 stated that some of the providers are providing telehealth services, like the radiology consults, and would not come to the facility.

The surveyor shared the current regulation and guidance and "External FAQ: CMS Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule" document with with SM #2 for the facility to review when updating their policy.

The above concerns were discussed at the exit conference on 2/15/2022 with SMs #1, #2, #3, and #10.