Failure to Obtain Informed Consent for Hormone Medication
Penalty
Summary
The deficiency involves the facility’s failure to ensure a cognitively intact male resident was fully informed of, and consented to, a hormone medication (medroxyprogesterone acetate/Provera) prescribed for sexual behaviors before it was administered. The resident, with a diagnosis of bipolar disorder and a BIMS score of 15/15, had no sexual behaviors identified or addressed in his comprehensive care plan. Nonetheless, an NP entered an order for Provera 5 mg by mouth daily for sexual behaviors, and the MAR showed the resident received two doses on consecutive evenings. Review of the electronic medical record revealed no evidence of a signed consent for Provera using the required HHSC Form 3713 prior to administration. Progress notes showed that on the same date the Provera order was initiated, the psychiatric provider evaluated the resident for worsening depression and anxiety, discontinued escitalopram (Lexapro), and started paroxetine (Paxil). A subsequent nursing note documented that the resident was started on Provera and paroxetine, and that he was educated on his medications and given printed information at his request, but there was still no documented written consent for Provera. The psychiatric physician later confirmed he did not prescribe Provera, only discussed it briefly as a medication ordered by the NP, and stated that obtaining signed consents was the facility’s responsibility. Interviews with staff and the resident further demonstrated that the resident had not been informed in advance or given the opportunity to consent in writing to Provera before receiving it. The resident reported learning from an outside case manager that he had been prescribed a hormone without his knowledge and stated he had not signed a consent and did not want medication for his sex drive. The DON and ADON each stated that the prescriber or the nurse taking the order was responsible for obtaining signed consent, but the facility was unable to produce a signed consent form for Provera or a policy on obtaining written consent for medications. This sequence of events shows the resident received Provera without the required informed, written consent.
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