Failure to Obtain Written Consent for Antipsychotic Medication and Dosage Increase
Penalty
Summary
The deficiency involves the facility’s failure to obtain proper written informed consent for the use and dosage increase of an antipsychotic medication for one resident. The resident was an elderly female with Alzheimer’s disease, vascular dementia, and a history of stroke, admitted with significant cognitive impairment as evidenced by a BIMS score of 00, indicating she was unable to complete the BIMS test. Her MDS reflected that she was receiving an antipsychotic medication. Physician orders showed quetiapine 50 mg at bedtime was initiated and later increased to two 50 mg tablets at bedtime, and the MAR confirmed that these doses were administered over several days. Record review of the resident’s electronic medical record revealed there was no HHSC Form 3713, Consent for Antipsychotic or Neuroleptic Medication Treatment, on file. A facility consent form for Seroquel lacked a resident or representative signature, and although a verbal consent was documented by a prior ADON for quetiapine 50 mg at bedtime, there was no evidence that side effects were discussed or that the representative acknowledged understanding them. There was also no documentation that the resident or her representative consented to or was aware of the increased dosage of quetiapine before it was administered. Interviews with staff confirmed that the facility’s process required obtaining signed consents, including HHSC Form 3713 and a psychotropic consent form, prior to administering antipsychotic medications. LVN A stated that medications could not be given until both consents were signed by the resident or representative. The CCN, interviewed with the Interim DON present, acknowledged that nurses were responsible for obtaining consents before administering psychoactive medications, that no consent for quetiapine or updated dosage could be found for this resident, and that the existing Seroquel consent form lacked a physical signature. The CCN also stated she was unaware that verbal consents were not appropriate for this medication and noted that changes in nursing administration and unfamiliarity with consent requirements may have contributed to the missing consent. Facility policy and an HHSC provider letter specified that written consent on Form 3713 must be obtained prior to the first dose, that verbal consent does not meet rule requirements, and that NF staff cannot sign on behalf of the resident.
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