Failure to Obtain and Renew Informed Consent for Psychotropic Medications
Penalty
Summary
The facility failed to ensure that residents and their responsible parties were fully informed and provided with appropriate, timely, and specific informed consent regarding the use of psychotropic medications. Multiple residents, including those with significant mental health diagnoses and those lacking capacity to make their own medical decisions, did not have their informed consents renewed every six months as required. In several cases, the consent forms did not specify the exact dose, frequency, or reasons for prescribing the medications, and the process for obtaining consent did not consistently involve direct communication between the prescribing physician and the resident's conservator or responsible party. For one resident with bipolar disorder, anxiety disorder, and substance use disorder, who had conservators for medical decisions, the medication consent form only listed medication names and dosage ranges, omitting the specific dose, frequency, and indications as required. The conservator confirmed that the physician did not directly contact them to obtain informed consent, and the process relied on faxed forms or verbal consent via nursing staff, without adequate explanation of the medications. The physician acknowledged that their signature on the consent form only verified the medication list and dosage range, not that informed consent had been properly obtained. Other residents, including those with no capacity to make decisions, were also affected. Informed consents for psychotropic medications such as risperidone, Lexapro, Belsomra, Seroquel, and Remeron were not renewed after six months, and facility policy and procedure documents had not been updated to reflect the new regulatory requirements for six-month renewals. Nursing staff and the DON confirmed that the required renewals had not occurred, and that the facility's tracking and policy review processes were insufficient to ensure compliance. These failures were identified through interviews, medical record reviews, and policy reviews, and were acknowledged by facility staff.