Failure to Obtain Informed Consent for Hypnotic Medication
Penalty
Summary
The facility failed to ensure that a resident with intact cognition and decision-making capacity was fully informed and provided with an opportunity to give informed consent prior to the administration of a hypnotic medication, specifically Zolpidem Tartrate (Ambien). The resident, who had significant medical conditions including acute respiratory failure with hypoxia, end stage renal disease, and heart failure, was admitted and readmitted to the facility. Documentation review revealed that the required informed consent form for the use of psychotropic and hypnotic medications was not signed by the resident, despite the resident's ability to understand and make decisions, as indicated in the medical record and assessment tools. Interviews with facility staff, including an LVN and the DON, confirmed that the informed consent process was not completed as required by facility policy. Both staff members acknowledged that the consent should have been obtained and that the omission meant the resident may not have been aware of the risks, benefits, or potential adverse effects of the medication. The facility's policy mandates that residents or their representatives must be informed and provide consent prior to the initiation of such medications, but this process was not followed in this instance.