F0578

D

Failure to Obtain Proper Consent for COVID-19 and Influenza Vaccinations

Cheektowaga, New York Survey Completed on 02-05-2026

Penalty

No penalty information released

Summary

The deficiency involves the facility’s failure to honor residents’ rights to refuse treatment and to obtain proper consent for immunizations, specifically COVID-19 and influenza vaccines, for two residents reviewed for immunizations. Facility policies for COVID-19 and influenza vaccination required that residents and/or resident representatives receive vaccine information sheets, be educated on risks and benefits, and that informed consent (written or verbal) be obtained prior to administration, with vaccination remaining voluntary. New York State regulations and federal resident rights documents cited in the report state that residents have the right to refuse medication and treatment after being fully informed, and that legal guardians or health care proxies have the right to make important decisions on the resident’s behalf when the resident lacks capacity.

Resident #1 had diagnoses including Alzheimer’s disease, vascular dementia, and a prior stroke, with the MDS documenting moderate cognitive impairment. The resident’s care plan showed multiple advance directives, including a MOLST, Health Care Proxy, and Power of Attorney, with a goal that the resident’s wishes be honored. A Determination of Incapacity for Medical Decision-Making documented that the resident lacked capacity and that the Health Care Proxy/Agent had been informed of this determination by two medical providers. Despite this, a Vaccination Review: Consent/Declination form recorded that the Assistant Director of Nursing/Infection Preventionist obtained verbal consent directly from the resident for influenza and COVID-19 vaccines, and the vaccines were administered. The Immunization Audit Report also showed prior refusals of other immunizations by the family/resident, and the order summary confirmed active Health Care Proxy status and vaccine orders. The resident’s Agent/Surrogate later stated they were responsible for medical decisions, were not asked for consent, were only notified after the vaccines were given, and would have declined them. The previous Unit Manager stated that Resident #1 lacked capacity, had documentation of incapacity, and that the spouse should have been called; they further stated that the Assistant DON/Infection Preventionist went room to room obtaining verbal consents from residents without verifying capacity, resulting in vaccinations against the Health Care Proxy’s wishes.

Resident #2 had diagnoses including dementia, encephalopathy, and COPD, with the MDS documenting severe cognitive impairment. The care plan described the resident as moderately impaired in decision making and referenced a cognitive level tool indicating Level 4 (moderately impaired). There was no initial documentation of capacity determination or advance directives in the care plan, but later orders showed that a Health Care Proxy was activated with an effective date prior to the vaccination clinic. The Vaccination Review: Consent/Declination form documented that the Assistant DON/Infection Preventionist obtained verbal consent from the resident for influenza and COVID-19 vaccines, and the vaccines were administered. The Immunization Audit Report and order summary confirmed the vaccines were given and that a Health Care Proxy order was in place. The Social Worker stated that a BIMS score under 12 indicated lack of capacity, that Resident #2 did not have the ability to make decisions, and that the Health Care Agent made decisions and should have been notified for vaccinations. The Assistant DON/Infection Preventionist stated they obtained consents verbally from residents and by phone from proxies, that it was not legal to vaccinate without proper consent, and acknowledged they did not document family consent for Resident #2 and should have done so. Resident #2’s Health Care Agent reported that vaccination consent was not discussed with them, they were unaware the vaccines were given, and that the resident would not have understood what they were consenting to. The DON, Administrator, and Medical Director all stated that capacity should be assessed (e.g., via BIMS and capacity forms), that if a resident lacks capacity the responsible party or Health Care Proxy must make decisions, and that residents who lack capacity should not receive vaccinations without proxy consent. These facts collectively demonstrate that the facility failed to ensure residents’ rights to refuse treatment and to obtain appropriate consent from authorized representatives before administering vaccines to two cognitively impaired residents.