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F0552
E

Failure to Obtain Informed Consent for Psychotropic Medications

Kalkaska, Michigan Survey Completed on 07-31-2025

Penalty

No penalty information released
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The penalty, as released by CMS, applies to the entire inspection this citation is part of, covering all citations and f-tags issued, not just this specific f-tag. For the complete original report, please refer to the 'Details' section.

Summary

The facility failed to ensure that written informed consent and education were provided prior to the administration of psychotropic medications for five residents reviewed. For each of these residents, including those with diagnoses such as dementia with behavioral disturbance, anxiety disorder, major depressive disorder, and psychotic disorder, psychotropic medications were initiated or continued without documentation of signed informed consents. There was no evidence in the electronic medical records that the risks, benefits, and alternatives to these medications were discussed with the residents or their legal representatives, such as guardians or those holding Durable Power of Attorney. Specific examples include residents who were prescribed medications such as Risperidone, Cymbalta, Alprazolam, Olanzapine, Wellbutrin XL, Nuplazid, Trazodone, Effexor XR, and Lurasidone. In each case, the medical records lacked documentation of informed consent forms or any indication that the medication regimens were discussed with the residents or their representatives. Requests made by surveyors to the Nursing Home Administrator (NHA) and Director of Nursing (DON) for these consent forms were not fulfilled, as no consents were provided by the time of survey exit. During interviews, the NHA and DON confirmed that the facility did not have a formal process for obtaining informed consent for psychotropic medications. They acknowledged that discussions with residents or their representatives regarding these medications were not consistently documented, and that no written information was consistently provided about the need for psychotropic medications, potential side effects, or alternative treatments.

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