Failure to Obtain and Verify Informed Consent for Neurofeedback Treatment
Penalty
Summary
The facility failed to ensure residents’ rights to informed consent for treatment were protected for two residents who had significant cognitive impairment. One resident with Parkinson’s disease and a Brief Interview for Mental Status (BIMS) score of 5, and another resident with unspecified dementia, aphasia, and a BIMS score of 2, were referred for and received brain mapping/neurofeedback treatment provided by a third-party vendor. The Administrator stated that the third-party provider was responsible for obtaining informed consent from the residents’ responsible parties and that the facility’s practice was to verify this by reviewing a copy of the consent and filing it in the residents’ medical records. During interviews and record reviews, the Administrator acknowledged that a copy of the informed consent for brain mapping/neurofeedback was not present in one resident’s medical record and that she had to request the informed consent for the other resident from the provider on the day of the survey. Additionally, the responsible party for one resident reported not being aware that the resident had been referred for brain mapping/neurofeedback, first learning of the treatment only after requesting a physician order summary, and stated that no consent had been given and the treatment had not been explained. The facility’s own informed consent policy required that residents or their surrogates receive material information in advance, consent to or refuse treatment or experimental research, and participate in care planning, and that facility staff verify that informed consent had been obtained, which did not occur in these cases.
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