Missing documented consent for COVID-19 vaccine administration
Summary
The facility failed to provide documented evidence that residents and/or their representatives were given the opportunity to change their decision regarding acceptance or declination of the COVID-19 vaccine before the vaccine was administered to two sampled residents. Resident #24, who was admitted with diagnoses including other sequelae of cerebral infarction and severe vascular dementia with anxiety, had a Record of Vaccination Acceptance and Declination Form signed on 06/04/2025 indicating the COVID-19 vaccine was accepted and that the resident and/or representative could change their mind at any time. However, the facility’s Vaccination Administration Forms showed the vaccine was administered on 01/17/2026 and 04/22/2026 without documented evidence that consent was obtained at the time of administration or that staff verified whether the resident or representative still wanted the vaccine. Resident #4, who was admitted with aphasia following cerebral infarction, had a Record of Vaccination Acceptance and Declination Form signed by the resident’s representative on 07/24/2025 documenting acceptance of the COVID-19 vaccine and stating the resident and/or representative could change their mind at any time. A facility Vaccination Administration Form documented that the vaccine was administered on 01/16/2026, but the form lacked documented evidence that consent was obtained at the time of administration or that staff verified whether the resident or representative had changed their decision before the vaccine was given. During interview on 06/11/2026, the DON and Infection Preventionist stated the facility reviewed WebIZ to determine vaccine eligibility, reviewed eligibility on admission and at least annually, and used the Record of Vaccination Acceptance or Declination Form to identify which vaccines residents were interested in. They stated staff were to ask the resident and/or representative again when the vaccine was due and complete a separate form at the time of administration. The DON and IP acknowledged the administration forms for Residents #4 and #24 lacked documented evidence of consent at the time of administration and lacked documentation that the resident or representative was given the opportunity to change their mind. The DON stated the expectation was that informed consent would be obtained before each vaccine, including verbal consent by phone when applicable, and acknowledged that failure to obtain consent at the time of administration denied the resident/representative the opportunity to decline the vaccine.
Penalty
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