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WAUKESHA MEMORIAL HOSPITAL 725 AMERICAN AVE WAUKESHA, WI 53188 Nov. 23, 2020
VIOLATION: PATIENT RIGHTS: INFORMED CONSENT Tag No: A0131
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on record review and interview, the hospital staff failed to follow their policies and procedures for education of psychotropic medications and obtaining informed consent prior to administration of psychotropic medications for 10 of 10 patients receiving psychotropic medications (Patient #1, #2, #3, #4, #5, #6, #7, #8, #9 and #10) in a total of 10 medical records reviewed.

Findings include:

Record review of policy titled "Behavioral health - Monitoring of Psychotropic Medications" dated 4/23/2020 under purpose statement revealed "procedures established to monitor the use of psychotropic medications... Procedure... 4) Prior to administering the medication, the nurse will educate the patient on the medication and obtain the patient's signature on a medication teaching sheet."

Review of Patient #1's medical record revealed Patient #1 was admitted [DATE] with hallucinations and discharged [DATE]. Medication administration record (MAR) revealed first dose of psychotropic medication administration of "benztropine" 4/29/2020 at 9:12 AM, "sertraline" 4/29/2020 at 9:12 AM, "risperidone" 4/29/2020 at 9:06 PM, "trazodone" 4/29/2020 at 9:06 PM, and "atarax" administered 4/30/2020 at 9:54 AM. Review of Patient #1's education and informed consent of psychotropic medications revealed consent for benztropine signed, dated 4/05/2020, not timed and consent for sertraline signed, not dated or timed. Date and time are required to establish that the consent was signed prior to administering the medication. There was no documented education or informed consent for risperidone, trazodone, or atarax.

Review of Patient #2's medical record revealed Patient #2 was admitted [DATE] with severe depression and discharged [DATE]. MAR revealed first dose of psychotropic medication administration of "sertraline" 6/01/2020 at 2:15 PM. Review of Patient #2's education and informed consent of psychotropic medications revealed consent for sertraline signed 6/01/2020, not timed to establish that the consent was signed prior to administration of the psychotropic medication.

Review of Patient #3's inpatient medical record revealed Patient #3 was admitted [DATE] with bipolar affective disorder. MAR revealed first dose of psychotropic medication administration of "sertraline" 11/12/2020 at 5:25 PM, "depakote" 11/12/2020 at 8:07 PM, and "trazodone", 11/12/2020 at 8:08 PM. Review of Patient #3's education and informed consent of psychotropic medications revealed consent for sertraline signed, dated 11/12/2020, not timed. There was no documented education or informed consent for depakote or trazodone.

Review of Patient #4's inpatient medical record revealed Patient #4 was admitted [DATE] for suicidal ideations and discharged [DATE]. MAR revealed first dose of psychotropic medication administration of "lithium" carbonate (CR) 5/09/2020 at 12:29 PM, "olanzapine" 5/09/2020 at 12:29 PM, "atarax" 5/14/2020 at 8:05 PM, and "prazosin" 5/13/2020 at 8:35 PM. Review of Patient #4's education and informed consent of psychotropic medications revealed consent for clozapine signed, not dated or timed. There was no documented education or informed consent for lithium CR, olanzapine, atarax or prazosin during the first admission. Patient #4 was readmitted [DATE] for suicide attempt and discharged [DATE]. MAR revealed first dose of psychotropic medication administration of "lithium CR" 6/01/2020 at 10:47 AM, "clozapine" 6/01/2020 at 8:58 PM, "trazodone" 6/01/2020 at 8:58 PM, "olanzapine zydis" 6/02/2020 at 8:20 PM, and "atarax" 6/04/2020 at 10:38 PM. Review of Patient #4's education and informed consent of psychotropic medications revealed consent for prazosin signed 5/13/2020, not timed. There was no documented education or informed consent for lithium CR, clozapine, trazodone, olanzapine zydis or atarax during the second admission.

Review of Patient #5's medical record revealed Patient #5 was admitted [DATE] for suicidal ideations and discharged [DATE]. MAR revealed first dose of psychotropic medication administration of "gabapentin" 5/06/2020 at 6:30 PM, "trazodone" 5/06/2020 at 9:46 PM, "naltrexone" 5/08/2020 at 5:24 PM, and "topiramate" 5/09/2020 at 9:27 PM. Review of Patient #5's education and informed consent of psychotropic medications revealed consent for naltrexone signed, not dated or timed. There was no documented education or informed consent for gabapentin, topiramate, or trazodone.

Review of Patient #6's medical record revealed Patient #6 was admitted [DATE] alcohol overdose and suicidal ideations and discharged [DATE]. MAR revealed first dose of psychotropic medication administration of "ziprasidone" 5/31/2020 at 9:18 PM, "venuafaxube" 6/01/2020 at 11:14 AM, "atarax" 6/01/20 at 8:46 PM, "trazodone" 6/01/2020 at 12:31 AM, and "bupropion" hydrochloride (HCL) 6/03/2020 at 12:05 PM. Review of Patient #6's education and informed consent of psychotropic medications revealed consent for bupropion signed, dated 6/03/2020, not timed. There was no documented education or informed consent for ziprasidone, venuafaxube, atarax or trazodone.

Review of Patient #7's medical record revealed Patient #7 was admitted [DATE] alcohol abuse, suicide thoughts and discharged [DATE]. MAR revealed first dose of psychotropic medication administration of "atarax" 10/28/2020 at 4:36 PM, "gabapentin" 10/28/2020 at 5:55 PM, "olanzapine" 10/28/2020 at 8:57 PM, "trazodone" 10/28/2020 at 8:57 PM, "acamprosate" 10/29/2020 at 9:10 PM, "divalproex" 10/29/2020 at 9:10 PM, and "mirtazapine" 10/29/20 at 9:10 PM. Review of Patient #7's education and informed consent of psychotropic medications revealed consent for mirtazapine signed, dated 10/29/2020, not timed, and divalproex signed, dated 10/29/2020, not timed. There was no documented education or informed consent for atarax, gabapentin, olanzapine, trazodone, acamprosate.

Review of Patient #8's medical record revealed Patient #8 was admitted [DATE] with auditory hallucinations and discharged [DATE]. MAR revealed first dose of psychotropic medication administration of "bupropion HCL" 6/01/2020 at 11:02 AM, "buspirone" 5/31/2020 at 10:43 PM, "gabapentin" 6/01/2020 at 3:51 PM, "atarax" 6/01/2020 at 6:28 PM, "olanzapine" 5/31/2020 at 10:43 PM, "sertraline" 6/01/2020 at 11:02 AM, and "trazodone" 5/31/2020 at 10:44 PM. There was no education or informed consent documentation for Patient #8's psychotropic medications during this admission (bupropion HCL, buspirone, gabapentin, atarax, olanzapine, sertraline, and trazodone).

Review of Patient #9's medical record revealed Patient #9 was admitted [DATE] for depression and anxiety and was discharged [DATE]. MAR revealed first dose of psychotropic medication administration of "clonazepam" 3/21/2020 at 8:50 AM, "fluoxetine" 3/21/2020 at 1:53 PM, and "atarax" 3/23/2020 at 4:21 AM. There was no education or informed consent documentation for Patient #9's psychotropic medications during this admission (clonazepam, fluoxetine, or atarax).

Review of Patient #10's medical record revealed Patient #10 was admitted [DATE] for suicidal ideation's and alcohol dependence and was discharged [DATE]. MAR revealed first dose of psychotropic medication administration of "lorazepam" 8/03/2020 at 5:26 AM, "atarax" 8/03/2020 at 12:14 PM, "olanzapine" 8/03/2020 at 9:13 PM, "trazodone" 8/03/2020 at 9:13 PM. "clonidine HCL" 8/05/2020 at 8:34 PM, "naltrexone" 8/07/2020 at 6:33 PM, and "sertraline" 8/07/2020 at 6:33 PM. Review of Patient #7's education and informed consent of psychotropic medications revealed consent for clonidine signed 8/05/2020, not timed. There was no documented education or informed consent for lorazepam, atarax, olanzapine, trazodone, naltrexone or sertraline.

On 11/18/2020 at 12:15 PM during interview with Registered Nurse (RN) S, RN S stated when the physician writes the patient's orders, if the patient has already been on the psychotropic medication prior to hospitalization , the informed consent is not signed by the patient, as stated in their policy, the patient is only educated and asked to sign an informed consent with new psychotropic medications that are prescribed. RN S stated "it's a work flow thing."

On 11/19/2020 at 8:11 AM during interview with the Director of Clinical Operations L, Director L indicated the hospital works closely with Integrated Behavioral Health Services and stated re-education is not completed and an informed consent obtained from each patient on each psychotropic medication on every inpatient admission, as indicated in their policy, stating "they are reviewed.,"