Failure to Obtain and Document Informed Consent for Psychotropic and Opioid Medications
Penalty
Summary
The deficiency involves the facility’s failure to obtain and document informed consent for psychotropic and opioid medications for multiple residents, despite a policy requiring such consent before administration. For one cognitively intact resident with dementia, diabetes, dysphagia, and acute kidney failure, the MDS showed use of antidepressant and opioid medications. Physician orders included PRN tramadol and oxycodone for pain and PRN trazodone for insomnia. Review of the electronic health record did not show signed consents for tramadol, oxycodone, or trazodone. An opioid consent form in the record had an effective date but did not identify the specific opioid medications. Medication administration records showed that tramadol and oxycodone were administered numerous times over several months without documented, medication-specific informed consent. Another resident with severe cognitive impairment, Alzheimer’s disease, dementia, dysphagia, and a cognitive communication deficit was receiving multiple psychotropic medications, including alprazolam, paroxetine, mirtazapine (Remeron), and risperidone. The facility produced signed consent forms for paroxetine, mirtazapine, and risperidone, but there was no documented consent for alprazolam, despite an active order for chronic anxiety. The orders for these medications had been in place and updated over an extended period, indicating ongoing use without complete corresponding consents for all psychotropic agents. A third cognitively intact resident with traumatic ischemia of muscle, opioid dependence with opioid-induced sleep disorder, chronic respiratory failure with hypoxia, and knee pain had an order for scheduled oral Dilaudid three times daily for pain. The EHR did not contain a signed consent specific to Dilaudid. An opioid consent form in the record had an effective date but did not list the name of the opioid medication. Staff interviews confirmed that nurses rely on the presence of orders in the EHR as an indication that consents have been obtained and do not routinely verify consent before administering psychotropic or opioid medications. The ADON and regional nurse acknowledged that consents are required, that forms in use did not include medication names, and that an opioid consent form had been created in-house without a field for the specific drug name, contributing to the lack of medication-specific informed consent documentation.
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