HospitalInspections.org

Based on document review and interview the hospital failed to ensure that informed consent for psychotropic medications was completed and properly executed before the administration of psychotropic medications in 3 (Patient #2, #4, and #7) of 5 (Patient #2, #3, #4, #6, and #7) patient charts reviewed. The hospital also failed to follow its policy, Policy #BHC.08.00.0005.

Findings:

On 11/30/2023 at 1:30 PM, medical records were reviewed with Staff #1, #15, and #16.

A review of the psychotropic medication consent document showed the initial statement to be:

"This patient has received a complete explanation of _______________(blank to specify medication/dosage) completed by staff ..."

At the bottom of the page was a statement that read, "I have received a complete explanation of the psychoactive medication(s) in writing."


Patient #2

Patient #2 was a 41-year-old female admitted to the hospital on 11/25/2023. A review of the medication orders and informed consents were as follows:

11/24/2023 at 3:09 PM, Zyprexa (antipsychotic) 5mg by mouth every 6 hours as needed for agitation. Patient #2 received 1 dose of this medication between 11/24/2023 and the survey exit date of 11/30/2023. The consent did not document the dosage of the medication.

11/24/2023 at 3:09 PM, Vistaril (antihistamine used for anxiety) 25mg by mouth every 6 hours as needed for anxiety. Patient #2 received 7 doses of this medication between 11/24/2023 and the survey exit date of 11/30/2023. The consent did not document the dosage of the medication only the name of the medication.

11/24/2023 at 3:09 PM Trazadone (antidepressant) 50 mg by mouth at bedtime as needed. Patient #2 received 4 doses of this medication between 11/24/2023 and the survey exit date of 11/30/2023. The consent did not document the dosage of the medication only the name of the medication.

11/28/2023 at 11:56 AM Trazadone (antidepressant) 100 mg by mouth at bedtime. Patient #2 received 1 dose of this medication between 11/24/2023 and the survey exit date of 11/30/2023. The consent did not document the dosage of the medication only the name of the medication.

11/29/2023 at 10:11 AM, Trazadone (antidepressant) 150 mg by mouth at bedtime. Patient #2 received 2 doses of this medication between 11/24/2023 and the survey exit date of 11/30/2023. The consent did not document the dosage of the medication only the name of the medication.

An interview was conducted with Staff #15 and #16 on 11/30/2023 at 2:30 PM. Staff #16 was asked if the informed consent for Trazadone should have had the medication dosage listed on the consent. Staff #16 stated, "Yes, it should. It says to list the medication and the dosage on the consent form." Staff #16 was asked which dosage of Trazadone did the signed informed consent apply to. Staff #16 stated, "There should have been a new consent each time the medication was increased but I can see that was not completed either. I do not know, but it would have to be for the order that was written on November 24th because the change in tie dosages was not made until November 28th and again on November 29th. There should have been new consents signed by Patient #2 every time the dosage was increased. The staff know that anytime the medication is increased it can change the patient's thought process and a new consent has to be completed."

11/25/2023 at 12:57 PM, Abilify (antipsychotic) 5 mg by mouth daily. Patient #2 received 2 doses of this medication. 5 mg was given by mouth on 11/25/2023 at 2:44 PM and 11/26/2023 at 8:03 AM.

11/26/2023 at 9:53 AM, Abilify (antipsychotic) 10 mg by mouth daily. Patient #2 received 3 doses of this medication. 10 mg was given by mouth on 11/27/2023 at 8:03 AM, 11/28/2023 at 8:02 AM, and 11/29/2023 at 8:33 AM.

Staff #16 confirmed there was no signed informed consent for the administration of Abilify in the patient's medical record before the medication was administered on 11/25/2023 and 11/26/2023. Staff #16 confirmed Patient #2 received 5 doses of the antipsychotic medication, Abilify, without a signed informed consent from the patient.
Staff #16 confirmed only one consent was signed by the patient on 11/30/2023. There was no dosage documented on the informed consent. The informed consent was signed and dated by Patient #2 and signed by a witness but there was no time documented when the consent was signed.


Patient #4

Patient #4 was a 56-year-old female admitted to the facility on 11/29/2023. A review of the medication orders and informed consents were as follows:

11/29/2023 at 12:26 PM Risperidone (antipsychotic) 1mg by mouth twice a day. The informed consent was signed and dated by Patient #4 on 11/29/2023 at 3:50 PM. Patient #4 received 3 doses of this medication. The nurse failed to document the dosage of medication on the informed consent.

11/29/2023 at 12:26 PM Haldol (antipsychotic) 5mg by mouth every 6 hours as needed for agitation. The informed consent was signed and dated by Patient #4 on 11/29/2023 at 3:53 PM. The nurse failed to document the dosage of medication on the informed consent.

11/29/2023 at 12:26 PM Vistaril 25 mg by mouth every 6 hours as needed for anxiety. The informed consent was signed and dated by Patient #4 on 11/29/2023 at 3:54 PM. The nurse failed to document the dosage of medication on the informed consent.

11/29/2023 at 12:26 PM Trazadone (Antidepressant/Sedative) 50mg at bedtime as needed for sleep. The informed consent was signed and dated by Patient #4 on 11/29/2023 at 3:53 PM. The nurse failed to document the dosage of medication on the informed consent.

11/30/2023 at 6:06 AM Valporic Acid (Depakene) 250mg by mouth three times a day. The informed consent was signed and dated by Patient #4 on 11/29/2023 at 3:50 PM. Patient #4 received 5 doses of this medication. The nurse failed to document the dosage of medication on the informed consent.


Patient #7

Patient #7 was a 32-year-old male admitted to the facility on 11/01/2023. A review of the medication orders and informed consents were as follows:

11/01/2023 at 4:26 PM Trazadone 50mg by mouth at bedtime as needed for sleep. The informed consent was signed and dated by Patient #7 on 11/01/2023 at 5:26 PM. Patient #7 received 5 doses of this medication. The nurse failed to document the dosage of medication on the informed consent.

11/01/2023 at 4:26 PM Haldol 5mg by mouth 3 times a day as needed for agitation. The informed consent was signed and dated by Patient #7 on 11/01/2023 at 5:36 PM. There was no witness signature or signature of the person who explained the risks and benefits of the medication to the patient. There was no documentation of the dosage of medication on the informed consent.

11/01/2023 at 4:26 PM Lorazepam 2mg by mouth 3 times a day as needed for agitation. The informed consent was signed and dated by Patient #7 on 11/01/2023 at 5:36 PM. The nurse failed to document the dosage of medication on the informed consent.

11/01/2023 at 4:26 PM Vistaril 25mg by mouth 3 times a day as needed for anxiety. The informed consent was signed and dated by Patient #7 on 11/01/2023 at 5:36 PM. Patient #7 received 4 doses of this medication. The nurse failed to document the dosage of medication on the informed consent.

11/02/2023 at 4:40 PM Invega (antipsychotic) SR 9mg by mouth at bedtime. Patient #7 received 1 dose of this medication on 11/02/2023 at 8:53 PM.

11/03/2023 at 3:31 PM Invega Sustenna 156mg Intramuscular 1 time dose. Patient #7 received one dose of this medication on 11/03/2023 at 8:54 PM.

Staff #15 confirmed in an interview on 11/30/2023 after 2:00 PM that Patient #7 gave verbal consent on 11/02/2023 at 8:30 PM for the administration of Invega. It was also confirmed there was no dose documented on the consent. Staff #15 stated, "There should be two separate consents for this medication. One for the oral medication and one for the IM injection. They know this. I guess we will have to get on this now and re-educate the staff regarding this problem."


A review of the facility Policy # BHC.08.00.0005 with a review date of 5/21 was as follows:

" ...SUBJECT: PHARMACY STANDARDS: PSYCHOACTIVE DRUGS: INFORMED CONSENT ...
DEFINITIONS
...
Psychoactive medication means a medication prescribed for the treatment of symptoms of psychosis or other severe mental or emotional disorders and that is used to exercise an effect on the central nervous system to influence and modify behavior, cognition, or affective state when treating the symptoms of mental illness. Psychoactive, education includes the following categories:

(a) Antipsychotic or neuroleptics
(b) Antidepressants;
(c) Agents for control of mania or depression;
(d) Antianxiety agents;
(e) Sedatives, hypnotics, or other sleep-promoting drugs, and
(f) Psychomotor stimulants

PROCESS STANDARDS

To facilitate the attainment of Outcome Standards:

A. Informed medication consent must be obtained for each individual medication, not by medication class. Any time the medication regimen is altered in a way that would result in a significant change in the risks or benefits for the patient, an explanation of the change is to be provided to the patient and/or the patient's legally authorized representative. The explanation is to include the notification of the right to withdraw consent at any time ...

E. The form titled Consent to treatment with psychoactive medication is to be utilized for documenting the explanation and patient consent. In addition, the nurse is to provide the patient or the legally authorized representative with written medication instruction specific to the prescribed medication ..."



Staff #15 and Staff #16 confirmed the medication dose should be documented on the informed consent and each time the medication dosage was changed there should have been a new informed consent completed. Staff #15 also confirmed the medication dosage was not properly documented on the informed consent in 3 (Patient #2, #4, and #7) of 5 (Patient #2, #3, #4, #6, and #7) patient charts reviewed.