Failure to Obtain Informed Consent Prior to Psychotropic Medication Administration
Penalty
Summary
The deficiency involves the facility’s failure to obtain and document informed consent for psychotropic medications prior to administration for three residents reviewed for unnecessary psychotropic drugs. For each of these residents, physician orders for psychotropic medications were in place and medications were administered, but corresponding psychotropic medication consent forms were either missing or completed only after the medications had already been started or doses changed. Pharmacist recommendations in each case explicitly stated that informed consent should be obtained at admission, prior to initiation of a psychotropic, or prior to increasing a dose, and noted that no consent forms could be found in the residents’ electronic health records. For one resident, multiple orders for Buspirone at varying doses were written and discontinued over several weeks, beginning in early October and continuing through early January. A pharmacist review in early November identified that a psychotropic consent form should be present but was not found in the record. The psychotropic medication consent form for Buspirone was later created and signed in mid-January, with the form documenting a consent date and time in early November, which was after the initial start of the medication and not contemporaneous with the actual creation and signing of the form. The ADON and the Regional Nurse Consultant both confirmed that the psychotropic consent form for this resident was not completed prior to medication administration and should have been. For a second resident, physician orders in June and August included Clonidine, Lorazepam, and Hydroxyzine for anxiety, with some orders scheduled and others as needed. A pharmacist review in mid-August again stated that informed consent should be obtained before initiation or dose increase of psychotropic medications and noted that no consent forms were present in the record. Psychotropic consent forms for Lorazepam, Clonidine, and Hydroxyzine were subsequently created and signed in September, each documenting consent dates in June, after the medications had already been ordered and used. For a third resident, Quetiapine was ordered via PEG-tube for anxiety in early November, and a pharmacist review in early December documented that a psychotropic consent form should be present but was not. The consent form for Quetiapine was later created and signed in mid-January, with a backdated consent date in early November. In interviews, the LPN stated that the ADON was responsible for completing psychotropic consent forms prior to administration, and the ADON and Regional Nurse Consultant confirmed for all three residents that the psychotropic consent forms were not completed before the medications were administered.
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