F0887

E

Failure to Provide and Document COVID-19 Vaccine Education, Consent, and Declination

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

Penalty

No penalty information released

Summary

The deficiency involves the facility’s failure to ensure that when COVID-19 vaccine was available, each resident was properly offered the vaccine, educated on its risks and benefits, and had their decision and education accurately documented in the medical record, as required by facility policy and regulation. The facility’s COVID-19 Vaccine Policy stated that residents who decline vaccination would provide a written affirmation indicating they were offered and declined the vaccine, that vaccination fact sheets would be made available prior to administration, and that informed consent (written or verbal) would be obtained from all individuals being vaccinated. However, the policy did not specify the minimum documentation requirements for the medical record, and in practice, the facility did not consistently obtain or record signed declinations or evidence of education.

For one resident reviewed in detail, Resident #3, who had diagnoses including psoriatic arthritis, COPD, and depression and was documented as cognitively intact, the Vaccination Review: Consent/Declination SNF Resident Form showed verbal consent for influenza and a documented decision to decline the COVID-19 vaccine. The declination statement on the form was not signed, and there was no documentation of verbal declination. There was also no evidence in the record that this resident received education regarding the risks and benefits of the COVID-19 vaccine. In interview, Resident #3 stated they wanted to receive the COVID-19 vaccine, reported never receiving written or verbal education about it, and stated they had not signed a declination. An Immunization Audit Report later documented that this resident refused the COVID-19 vaccine on a specific date and that no education was provided.

Further review of 34 additional resident Vaccination Review: Consent/Declination forms for residents indicated to have declined the COVID-19 vaccine revealed there were no signed declinations and no documentation that Vaccine Information Sheets or other education on risks, benefits, and potential side effects had been provided to the residents or their representatives. Staff interviews confirmed that when residents declined vaccinations, the declination section of the form should have been completed with a signature or verbal declination notation and that education on risks and benefits should have been provided and documented. The Assistant DON/Infection Preventionist acknowledged responsibility for providing vaccination education but had no evidence that such education was completed, and a former unit manager stated they did not provide vaccination education or obtain consents/declinations for a prior influenza/COVID-19 clinic. Leadership interviews further confirmed expectations that both consent and declination statements be signed when applicable and that risks versus benefits be reviewed prior to obtaining decisions, which did not occur as required in these cases.