Failure to Obtain Accurate Informed Consent for Medications and Vaccines
Penalty
Summary
The facility failed to ensure that informed consents explaining the potential risks and benefits associated with psychotropic medications and vaccines were accurately completed and obtained from residents or their representatives prior to administration. For one resident with depression, psychotropic medication (Duloxetine) was administered daily for 12 days before the resident signed the informed consent form. The nurse manager confirmed that the consent was not obtained prior to the first dose, as required, and no earlier consent was found in the records. For another resident with dementia and bipolar disorder, who had severely impaired cognitive skills and required assistance with all decision making, staff obtained and accepted vaccine consents signed by the resident, despite documentation that the resident was not capable of making informed decisions. Additionally, the informed consent for a psychotropic medication (Depakote) was completed under the wrong medication category, providing inaccurate information to the resident's representative. The nurse manager acknowledged these errors, confirming that the consents should have been obtained from the resident's next of kin and that the medication category was incorrectly documented.