Failure to Obtain Informed Consent for Psychoactive Medication
Penalty
Summary
The facility failed to ensure that a resident and/or their responsible party was informed in advance of the risks and benefits of psychoactive medication. This deficiency was identified for one resident who was receiving Seroquel and Duloxetine HCI. The resident, who had a history of diabetes mellitus, chronic kidney disease, and bipolar disorder, was assessed to have the capacity to understand and make decisions. Despite this, there was no informed consent documented in the resident's chart for the administration of these medications. Interviews with facility staff, including a registered nurse, the assistant director of nursing, and the director of nursing, confirmed that informed consent should have been obtained and documented before administering the medications. The facility's policies and procedures also required informed consent to be documented in the resident's medical record. The absence of informed consent documentation meant that the resident might have been administered medication without being fully informed or having the opportunity to decline it.
Plan Of Correction
How corrective actions will be accomplished for those residents found to have been affected by this deficient practice: On 3/7/25, the Minimum Data Set Nurse (MDSN) Assistant clarified Resident 46 psychotropic medication and received informed consent from Resident 46 to administer Seroquel and Duloxetine psychotropic medication. How the facility will identify other residents having the potential to be affected by the same deficient practice and what corrective action will be taken: All residents have the potential to be affected by this deficient practice. On 3/11/25, the Medical Records Director conducted an audit on all active residents' psychotropic medications to ensure psychotropic informed consents were completed. No other residents were affected by this deficient practice. What measures will be into place or what systemic changes the facility will make to ensure that the deficient practice is not recur: On 3/10/25, the Director of Nursing in-serviced Nursing Staff, including but not limited to License Vocational Nurses and Registered Nurses, on the facility's policy and procedure titled, "Informed Consent," with emphasis on ensuring the facility respects the resident's right to make an informed decision prior to deciding to undergo certain medical therapies and procedures. The in-service also included ensuring the informed consent/notice be documented, and placed in the resident's medical record for verification that consent/notice was given. On 3/10/25, the Director of Nursing in-serviced Nursing Staff, including but not limited to License Vocational Nurses and Registered Nurses, on the facility's policy and procedure titled, "Psychotherapeutic Drug Management," with emphasis on obtaining consent for use of psychotherapeutic drugs, informing the resident of the risks and benefits for the use of these medications, and ensuring the consent remains in place until medication is discontinued or until consent is revoked by the resident/responsible party. The Medical Records Director will conduct audits on psychotropic consent forms daily for 5 days, weekly for 2 weeks, and monthly thereafter to ensure residents have received informed consent prior to the administration of psychotropic medication. How the facility plans to monitor its performance to make sure that solutions are maintained: The Social Service Director will report to the Quality Assessment and Assurance Committee during its monthly meeting the status of the compliance for receiving informed consent prior to the administration of psychotropic medication for three months or until compliance is met.