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ORLANDO HEALTH 52 W UNDERWOOD ST ORLANDO, FL 32806 July 7, 2016
VIOLATION: PATIENT RIGHTS: INFORMED CONSENT Tag No: A0131
Based on interview, record review and a review of facility documentation, the facility failed to ensure that patients for whom psychotropic medication had been ordered had the right to make informed decisions, either directly or through a guardian, regarding the administration of such medication in one of ten sampled patients. (#1)

Findings:

The medical record of patient #1 was reviewed. The patient had been placed on a Baker Act on 5/12/16, prior to his admission to the emergency room at Orlando Health. This is a provision under State of Florida law for patients who have been deemed as having a propensity to harm themselves or others. This was prior to the patient's eventual admission at South Seminole hospital.

The record at Orlando Health had documentation for Plenary Guardianship, but it could not be determined when it was placed in the record. It designated the patient's mother as the guardian.

The patient was admitted to the South Seminole Hospital Behavioral Health Unit as a transfer on 5/13/16. A mental health technician (MHT) note of 5/13/16 at 9:55 PM read, "admitted to unit...."

Physician orders of 5/15/16 at 1:18 PM read, "Aripiprazole oral (Abilify) give 15 MG (milligrams) PO (by mouth), daily." The record revealed that the patient signed to be under voluntary treatment (via the"Application for Voluntary Admission") on 5/15/16 at 8:20 PM. The record revealed that Abilify was given daily on 5/16/16 through 5/19/16. On 5/16/16, it was given at 8:46 AM. There was no evidence in the record that the patient had been informed of any risk regarding Abilify or was asked for permission or consent to give it. The record revealed that the patient received a second opinion confirming placement on a Baker Act 32 at 2:35 PM on 5/16/16. This converted the patient back to an involuntary status. The record revealed that he remained on this status through 5/23/16.

The patient continued to receive Abilify through 5/19/16, under an involuntary status. The patient's guardian would have had the authority to speak for the patient during this time period.

The record also included an undated form "Specific Authorization for Psychotropic Medications" with the words "Abilify 10-60 MG a day" typed in an available space for medication listings. The document had handwritten text across the page which read, "Family refused stop med." The form had no indication that it was used to request permission of the guardian to give Abilify.

A review of facility's policy "Authorization of Psychotropic Meds" revealed the following: "This policy is to ensure each... decision maker is informed as to the purpose, expected outcome and potential adverse reaction to any psychotropic medications.... It is the policy of Behavioral Health Services to follow the Florida Mental Health (Baker Act) 394, Part I, Florida Statutes, for the authorization of psychotropic medications.... Complete form CR-MH302B 'Specific Authorization for Psychotropic Medications' listing each medication with minimum and maximum dose range. The.... decision maker will sign the authorization form and witness prior to administration of medication."

The patient was under a Baker Act at the time of admission and was still under the Baker Act at the time of the above order for Abilify. He was under Voluntary classification at the time of the first administration of Abilify on 5/16/16. He was back on Involuntary status later in the day on 5/16/16 through the last day of the administration of Abilify on 5/19/16.

Since the facility gave Abilify to the patient without authorization from the patient himself on 5/16/16, when he was on voluntary status, and from the decision maker (guardian) on 5/17/16 through 5/19/16, when he was under a Baker Act 32, the facility was in violation of the above policy.

During an interview of the Risk Manager on 7/07/16 at approximately 3:30 PM, she confirmed the finding.