HospitalInspections.org

Based on interview and document review, it was determined the facility staff failed to obtain informed consent prior to administering a COVID-19 vaccine for one (1) of five (5) patients sampled (Patient #9).

The findings include:

The surveyor conducted a review of the medical record for Patient #9 from October 25, 2022 through October 26, 2022. The record review revealed Patient #9 was admitted to the facility on May 9, 2022 for "ESBL Pseudomonas UTI" and discharged on May 19, 2022 to a skilled nursing facility. Patient #9 was not a primary English speaker and required the use of a translator. Staff Member #4 described the patient's course of treatment as a "complicated stay with lethargy and hypoxia." A review of nursing and practitioner assessments conducted during the patient's stay revealed descriptions of the patient's mental status as alert to self, lethargic, sleepy/drowsy, and unresponsive.

In a nursing note entered by Staff Member #7 on May 17, 2022, the note advised the patient was not responding to staff and would not respond to the translator. Conversely, the same note indicated that Staff Member #7 administered a COVID-19 vaccine and the COVID-19 vaccination documentation indicated the patient provided verbal consent. The note further indicated that a family member was notified of the vaccine administration after administration but not prior too.

During an interview with Staff Member #4 and Staff Member #5 on the afternoon of October 26, 2022, the staff members advised that staff should try to use available "resources" if they encounter challenges communicating with a patient and that one family member is usually listed in the record as a contact person.

A review of the facility document titled "Inpatient COVID-19 Screening and Vaccination" states in part:

"Patients.... will be required to review the FDA's FACT SHEET FOR RECIPIENTS AND CAREGIVERS and provide verbal consent to receive the vaccine.."