Failure to Obtain Proper Informed Consent for Vaccinations
Penalty
Summary
Facility staff failed to obtain proper informed consent for COVID-19 and influenza vaccinations for a resident with cognitive impairment. The resident, who had diagnoses including schizophrenia and was documented as lacking capacity for medical decision-making, was recorded as having verbally declined both vaccinations. However, according to the facility's policy and the Director of Nursing, residents without decision-making capacity should not be providing consent or declination themselves; instead, consent or declination should be obtained from the resident's representative or family member. Record reviews showed that the resident's medical history and assessments indicated impaired cognition and mental incapacitation. Despite this, the facility documented the resident's own verbal declination for both vaccines, rather than obtaining the required authorization from a representative. The facility's policy requires that informed consent or declination for vaccinations be obtained from the appropriate decision-maker and properly documented, which was not followed in this case.