Incomplete informed consent for psychotropic medications
Summary
The facility failed to ensure informed consent for psychotropic medications was obtained and properly documented before administration for four sampled residents. Across the records reviewed, psychotropic medication consent forms were repeatedly incomplete, with missing physician signatures, missing representative signatures or dates, missing staff signatures, and in some cases missing medication frequency, dose details, or the correct ordered medication information. The Director of Nursing stated the forms were not filled out entirely but should have been, and that the physician was expected to explain the medication risks and benefits and obtain consent before administration. Resident 1 had diagnoses including dementia, diabetes mellitus, and atherosclerotic heart disease, and the H&P stated the resident did not have the capacity to understand and make decisions. The resident received quetiapine fumarate 12.5 mg daily and PRN and 25 mg at bedtime, and later Trileptal 300 mg twice daily. The psychotherapeutic drug informed consent forms for these medications included staff signatures but did not include physician signatures or dates, and did not include the representative’s name, signature, or date. The DON stated the physician did not sign the form and without the physician’s signature the medications were not allowed to be given, but the forms were not completed as required. Resident 2 had diagnoses including dementia, mood affective disorder, and depression, and the H&P stated the resident did not have capacity to understand and make decisions. The resident received risperidone 0.25 mg twice daily, donepezil 10 mg at bedtime, and memantine 10 mg twice daily. The consent forms for risperidone, donepezil, and memantine were incomplete, with missing physician signatures and dates, and the chart did not contain consent forms for the ordered doses of donepezil 10 mg and memantine 10 mg. Resident 3 had diagnoses including depression, anxiety disorder, and insomnia, and the H&P stated the resident had capacity to understand and make decisions. The resident received trazodone 150 mg at bedtime and mirtazapine, but the consent forms lacked physician signatures, dates, and representative signatures or dates, and the chart did not include a consent form for the ordered mirtazapine 7.5 mg dose. Resident 4 had diagnoses including anxiety, unspecified psychosis, and alcohol abuse, and the H&P stated the resident had capacity to understand and make decisions. The resident received quetiapine, Ativan, and mirtazapine, but the consent forms were incomplete or undated, lacked required signatures, and the chart did not include a consent form for the ordered Ativan and later mirtazapine via g-tube. The facility’s P&P required residents and/or representatives to be fully informed of benefits, risks, frequency, duration, and alternatives before psychotropic medications were initiated, and required the prescriber to sign the informed consent form after explaining the information.
Penalty
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