Failure to Ensure Informed Consent for Psychoactive Medication
Penalty
Summary
The licensed nursing staff at the facility failed to ensure that a resident and/or their responsible party were fully informed about the risks and benefits of a psychoactive medication, specifically Zoloft, which is used to treat mental and mood disorders. The deficiency was identified for a resident who was admitted with diagnoses including major depressive disorder and acute respiratory failure with hypoxia. The resident's Minimum Data Set indicated intact cognition and the ability to make self-understood decisions. However, the Psychotherapeutic Medication Informed Consent Form for Zoloft did not specify the dosage, nor were the consent boxes checked to confirm the resident's agreement to take the medication. Interviews with the Registered Nurse and the Director of Nursing confirmed the omission of the dosage and unchecked consent boxes on the informed consent form. The facility's policy on informed consent, last reviewed in December 2024, requires that all material information be provided to residents to make informed decisions about their treatment, including the administration of psychotherapeutic drugs. The failure to include the dosage and obtain explicit consent violated the resident's right to make an informed decision regarding their medication.
Plan Of Correction
F552 A. How corrective action(s) will be accomplished for those residents found to have been affected by the deficient practice: Resident 34's physician provided informed consent for the use of Zoloft, including the strength of medication and Resident 34's acceptance or refusal of recommended psychotherapeutic medications on 02/27/2025. B. How the facility will identify other residents having the potential to be affected by the same deficient practice and what corrective action was taken: Residents using psychotropic medications without complete physician informed consent, including the dosage and the resident's choice to accept or refuse recommended medications, are potentially affected by the facility practice. The Director of Medical Records/designee audited the physician orders for residents who receive psychotherapeutic medications to verify the presence of a completed informed consent in the medical record and to identify residents who may potentially be affected by the facility practice on 3/20/2025. A total of 39 records were reviewed, and 0 records were identified with incomplete informed consents. C. What measures will be put into place or what systematic changes the facility will make to ensure that the deficient practice does not recur: The Director of Staff Development/designee will re-educate licensed nurses and social services employees on the facility's Informed Consent policy with emphasis on verifying informed consent for the use of psychotropic medications on or before 03/20/2025. The DSD orients applicable new employees upon hire, annually, and as needed on the facility's Informed Consent policy and procedure, including verifying informed consents are complete with the dosage of medication and the resident's choice for the use of recommended psychotherapeutic medications. The Director of Medical Records will audit the orders of residents' psychotropic medications to verify informed consent has been provided by the physician monthly, including documentation of the dosage and resident's choice, and provide physician orders for residents who receive psychotherapeutic medications to verify the presence of a completed informed consent in the medical record and to identify residents who may potentially be affected by the facility practice on 3/20/2025. A total of 39 records were reviewed, and 0 records were identified with incomplete informed consents. The measures to prevent recurrence include re-education of licensed nurses and social services employees on the facility's Informed Consent policy, orientation for new employees, monthly audits by the Director of Medical Records, and ongoing monitoring by the Director of Social Services. The Director of Staff Development will re-educate staff on or before 03/20/2025, and the Director of Medical Records will continue monthly audits, providing completed audits to the Director of Nursing for tracking and trending analysis. The Director of Social Services will monitor resident physician order changes weekly to ensure residents using psychotropic medications have completed verified informed consent. D. How the facility plans to monitor its performance to make sure solutions are sustained: The IDT will review physician order changes four days weekly in the morning clinical meeting to ensure residents with orders for psychotherapeutic medications have evidence of a verified complete informed consent in the record. The Director of Staff Development will monitor the completion of staff training during new hire orientation and as needed on the facility's Informed Consent procedures, including verification of complete informed consent for the use of psychotropic medications. The Pharmacy Consultant shall monitor the medication regimen of residents each month to identify unnecessary medications and report the results to the Director of Nursing and QAA quarterly. The Director of Social Services will monitor the Medical Records verification of informed consent audit to identify variance to standard concerns and maintain compliance with this plan of correction. The Director of Nursing/designee will report significant trends identified to the QAPI/QAA Committee at least quarterly for the purpose of process improvement through root cause analysis and committee-recommended interventions to ensure continued compliance with this plan of correction. Allegation of Compliance Date: 03/25/2025.