Failure to Obtain and Document Informed Consent for Psychotropic Medications
Penalty
Summary
The deficiency involves the facility’s failure to obtain and document informed consent for psychotropic medications prior to initiation or dose changes for multiple residents. For one resident with unspecified dementia, anxiety disorder, depression, and delusional disorder, the physician ordered quetiapine for anxiety and agitation and later ordered divalproex for dementia with aggression and agitation, with a subsequent dose increase. The resident’s MDS showed moderate cognitive impairment, use of antipsychotic, antidepressant, and anticonvulsant medications, and behavioral symptoms including rejection of care. Record review showed these medications were administered as ordered, but there was no documentation that the responsible party was informed in advance of the risks and benefits of starting or increasing these psychotropic medications or that consent was obtained. Another resident with anxiety disorder and depression was started on duloxetine for depression and later had PRN lorazepam ordered for daytime and bedtime anxiety with agitation. The MDS indicated severe cognitive impairment, behavioral symptoms that interfered with social interactions and disrupted care, and use of anti-anxiety and antidepressant medications. The MAR confirmed that duloxetine was given as ordered and lorazepam was administered on multiple days. However, the electronic medical record contained no documentation that the responsible party was informed in advance of the risks and benefits of initiating duloxetine or lorazepam or that consent was obtained. The Nurse Team Lead, who was responsible for obtaining psychotropic consents, could not locate any consent forms for this resident and could not recall whether the responsible party had been called. A third resident with major depressive disorder and generalized anxiety disorder, and intact cognition per the MDS, had an active order for escitalopram 20 mg daily for depression and anxiety. The MDS showed no behavioral symptoms and receipt of antidepressant medication. Review of the medical record revealed no documentation that this resident was informed in advance of the risks and benefits of initiating escitalopram and consented to the treatment. In interviews, the Nurse Team Lead consistently stated she was responsible for obtaining psychotropic consents when new orders were received from providers, but she was unable to find consent forms for the involved residents or explain what had occurred. The DON described a process in which providers communicated new or changed psychotropic orders to the Nurse Team Lead, who was expected to notify residents or responsible parties and document the notification, but acknowledged that for these residents the required documentation and consent forms were missing.
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