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Based on interview, record review, and review of the hospital's policies and procedures, the hospital failed develop and implement policies and procedures to ensure that the patient's rights were protected by providing informed consent (detailing the risks, benefits, and alternatives) for all prescribed psychotropic medications prior to medication administration, as demonstrated by 9 of 9 records reviewed. (Patient #1501, #1502, #1503, #1504, #1505, #1506, #1507, #1508, and #1509).

Failure to ensure that the hospital developed and implemented policies and procedures to ensure that patients receive informed consent for all psychotropic medications prior to medication administration, violated the patient's rights to receive details of the risks, benefits, and alternatives for all psychotropic medications.

Findings included:

1. Document review of the hospital's policy titled, "Administration of Medication without Formal Consent," policy number 1000.52, last revised 06/21, showed the following:

a. It is the policy of Fairfax Behavioral Hospital to obtain informed consent of involuntary patients prior to the administration of antipsychotic medications unless it is determined that criteria are met to waive that consent, such as the following:

i. Emergency Involuntary Medication - Involuntary Patient

ii. Nonemergency Involuntary Medication - Involuntary Patient

iii. Emergency Involuntary Medication - Voluntary Patient

Document review of the hospital's document titled, "Medical Staff Rules and Regulations," last reviewed 2017, showed that the physician shall discuss fully with the patients and appropriate relatives the indications and side effects of prescribed medications with documentation as established by the facility and accepted medical practice. Consistent with Washington State regulations, agreement to take antipsychotic medications by the patient or guardian must be specificially noted.

Patient #1501

2. On 08/23/22, Investigator #15 reviewed the medical record for Patient #1501, a 20-year-old female admitted on an involuntary detention on 08/04/22, with a psychiatric diagnosis of Schizophrenia Spectrum Disorder and a medical diagnosis of Hypokalemia (elevated potassium). Based on information provided by Patient #1501's family, she had been decompensating for 3 weeks. Review of the Patient's medical record showed the following:

a. On the Informed Consent dated 08/05/22, the psychiatric provider documented that Patient #1501 was provided with informed consent, explaining the benefits, risks, alternative options, Black Box warnings (medications that carry serious safety risks), and most common side effects for the following psychotropic medication: Ativan.

b. Review of the medical record between 08/04/22 to 08/23/22, showed that the psychiatric providers ordered the following additional psychotropic medications during Patient #1501's admission:

i. Seroquel ordered on 08/04/22 (Indication: Agitation)

ii. Trazadone ordered on 08/04/22 (Indication: Insomnia)

iii. Vistaril ordered on 08/04/22 (Indication: Anxiety)

iv. Haldol ordered on 08/05/22 (Indication: Psychosis)

v. Benadryl ordered on 08/05/22 (Indication: Agitation)

vi. Risperidone ordered on 08/16/22 (Indication: Psychosis)

vii. Zyprexa ordered on 08/21/22 (Indication: Agitation)

c. Investigator #15's review of the medical record for Patient #1501 found that staff failed to document that informed consent for psychotropic medications was provided to the Patient for 7 of 8 psychotropic medications ordered.

3. On 08/23/22, the Assistant Director of Nursing (Staff #1507) verified that the medical record for Patient #1501 was missing the staff's documentation of informed consent for 7 of 8 psychotropic medications. Staff #1507 stated that she would speak with the providers to find out where the documentation is located.

Patient #1502

4. On 08/23/22 and 08/24/22, Investigator #15 reviewed the medical record for Patient #1502, a 52-year-old female admitted on an involuntary detention on 08/01/22, with a psychiatric diagnosis of Bipolar Disorder, Generalized Anxiety Disorder, and Adjustment Disorder and a medical diagnosis of Hypothyroidism. Patient #1502 was admitted for acute mania, agitation, and combativeness. Review of the Patient's medical record showed the following:

a. On the Informed Consent dated 08/01/22, the psychiatric provider documented that Patient #1502 been provided with informed consent, including the benefits, risks, alternative options, Black Box warnings (medications that carry serious safety risks), and most common side effects for the following psychotropic medications: Haldol, Abilify, and Depakote.

b. Review of the medical record between 08/01/22 to 08/23/22, showed that the psychiatric providers ordered the following additional psychotropic medications during Patient #1502's admission:

i. Thorazine ordered on 08/01/22 (Indication: Severe Agitation)

ii. Seroquel ordered on 08/01/22 (Indication: Agitation)

iii. Vistaril ordered on 08/01/22 (Indication: Anxiety/Restlessness)

iv. Ativan ordered on 08/01/22 (Indication: Anxiety)

v. Benadryl ordered on 08/04/22 (Indication: Agitation)

vi. Trazadone ordered on 08/01/22 (Indication: Insomnia)

c. Investigator #15's review of the medical record for Patient #1502 found that staff failed to document that informed consent for psychotropic medications was provided to the Patient for 6 of 9 psychotropic medications ordered.

Patient #1503

5. On 08/24/22, Investigator #15 reviewed the medical record for Patient #1503, a 26-year-old female admitted on an involuntary detention on 07/28/22, with a psychiatric diagnosis of Schizoaffective Disorder. Patient #1503 was admitted for suicidal ideation, psychosis, and medication non-compliance. Review of the Patient's medical record showed the following:

a. Review of the medical record between 07/28/22 to 08/24/22, showed that the psychiatric providers ordered the following psychotropic medications during Patient #1503's admission:

i. Vistaril ordered on 07/28/22 (Indication: Severe Anxiety)

ii. Seroquel ordered on 07/28/22 (Indication: Agitation)

iii. Thorazine ordered on 07/28/22 (Indication: Severe Agitation)

iv. Zyprexa ordered on 07/28/22 (Indication: Psychosis)

v. Lithium ordered on 07/28/22 (Indication: Mood Instability)

vi. Depakote ordered on 07/29/22 (Indication: Psychosis)

vii. Olanzapine ordered on 07/29/22 (Indication: Psychosis)

viii. Trazadone ordered on 08/17/22 (Indication: Insomnia)

ix. Buspirone ordered on 08/19/22 (Indication: Anxiety)

x. Abilify ordered on 08/25/22 (Indication: Psychosis)

b. Investigator #15's review of the medical record for Patient #1503 found that the informed consent was missing. Staff failed to document that informed consent for psychotropic medications was provided to the Patient for 10 of 10 psychotropic medications ordered.

6. On 08/24/22, the Director of Risk Management (Staff #1501) verified that the medical record for Patient #1503 was missing the informed consent form. The hospital staff was unable to locate the missing document and update the medical record while the investigators were on site.

7. Further review of the medical records for Patient #1504, #1505, #1506, #1507, #1508, and #1509 showed consistent findings related to the staff's failure to document informed consent for all psychotropic medications prior to administration:

i. Staff failed to document informed consent for 4 of 6 psychotropic medications for Patient #1504: Thorazine, Vistaril, Trazadone, and Haldol.

ii. Staff failed to document informed consent for 3 of 6 psychotropic medications for Patient #1505: Vistaril, Seroquel, and Invega Sustenna.

iii. Staff failed to document informed consent for 1 of 6 psychotropic medications for Patient #1506: Zyprexa.

iv. Staff failed to document informed consent for 7 of 8 psychotropic medications for Patient #1507: Trazadone, Vistaril, Olanzapine, Depakote, Zyprexa, Haldol, and Benadryl.

vi. Staff failed to document informed consent for 4 of 8 psychotropic medications for Patient #1508: Benadryl, Trazadone, Vistaril, and Thorazine.

vi. Staff failed to document informed consent for 7 of 7 psychotropic medications for Patient #1509: Trazadone, Vistaril, Zyprexa, Haldol, Risperidone, Depakene, and Thorazine. The informed consent form was missing from the Patient's medical record.

8. On 08/25/22 at 11:10 AM, during an interview with Investigator #15 and Investigator #12, the Chief Medical Officer (CMO) (Staff #1512) stated that the informed consent for psychotropic medications form documents consent for any psychotropic medications that are prescribed. The providers should be educating the patients on the risks and benefits of these medications. Typically, the form is filled out and signed by the patient and provider when the psychiatric provider meets with the patient for the initial psychiatric evaluation. Then, when any psychotropic medications are added during the patient's admission, the provider should complete a new form or add to the existing document. The CMO stated that the providers will also document the addition of any new medications for the patients on their daily provider progress notes. Staff #1512 verified that the medical records reviewed failed to include an informed consent. Staff #1512 stated that he was unsure of previous training regarding the informed consent process for the psychiatric providers.

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Based on interview, medical record review, and review of hospital policy and procedures, the hospital failed to ensure that a face to face evaluation was reviewed by an attending physician within 30 minutes of the evaluation for 5 of 6 patient records reviewed (Patients #1501, #1502, #1507, #1508, and #1509) for restraint and seclusion.

Failure to ensure that a face to face evaluation is reviewed by an attending physician within 30 minutes of the evaluation places patients at risk for physical or psychological harm related to restraint and seclusion use.

Findings included:

1. Review of the hospital policy titled, "Proper Use and Monitoring of Physical-Chemical Restraints and Seclusion," policy number 1000.53, approved 06/21, showed the following:

a. Within one hour of initiation of restraint or seclusion, the patient shall be evaluated in person by a physician, an authorized licensed independent practitioner (LIP), or a trained registered nurse (QRN) or physician assistant (PA).

b. If the evaluation is conducted by a QRN or PA, they must consult with the attending physician or other LIP responsible for the patient's care as soon as possible (within 30 minutes) after the evaluation. The consultation should include a discussion of the findings of the 1-hour evaluation, the need for other interventions or treatments, and the need to continue or discontinue the use of restraint or seclusion.

2. Review of Patient #1501's medical record showed that the patient was in restraint or seclusion four times on four different days:

a. On 08/05/22, the face to face evaluation was completed by the QRN at 10:15 AM, and the documented review time with the patient's attending physician was 10:00 AM, which was 15 minutes before the face to face assessment;

b. On 08/14/22, the face to face evaluation was completed by the QRN at 8:23 PM, and the documented review time with the patient's attending physician was 7:25 PM, which was 58 minutes before the face to face assessment;

c. On 08/20/22, the face to face evaluation was completed by the QRN at 7:55 PM, and the documented review time with the patient's attending physician was at 9:56 PM.

3. Review of Patient #1502's medical record showed that the patient was in restraint or seclusion 7 times on 4 different days. On 08/03/22, the face to face evaluation was completed by the QRN at 10:35 PM, and the documented review time with the patient's attending physician was 10:30 PM, which was 5 minutes before the face to face assessment.

4. Review of Patient #1507's medical record showed that the patient was in restraint or seclusion 3 times on 3 different days. On 08/02/22, the face to face evaluation was completed by the QRN at 10:50 AM, and the documented review time with the patient's attending physician was 10:32 AM, which was 18 minutes before the face to face assessment.

5. Review of Patient #1508's medical record showed that the patient was in restrain or seclusion 3 times on 2 different days:

a. On 08/11/22, Patient #1508 was restrained physically and chemically and placed in seclusion. Staff documented the time of initiation of the intervention at 12:55 PM. The QRN completed the face to face evaluation at 7:50 PM, but the nurse failed to document the time of review with the attending physician.

b. On 08/12/22, the face to face evaluation was completed at 2:06 PM, and the documented review time with the patient's attending physician was 1:30 PM, which was 36 minutes before the face to face assessment.

6. Review of Patient #1509's medical record showed that the patient was restrained once. On 08/08/22, the face to face evaluation was completed at 9:54 PM, and the documented review time with the patient's attending physician was 9:50 PM, which was 4 minutes before the face to face assessment.

7. In an interview with the Assistant Director of Nursing (Staff #1507) on 08/24/22 at 3:00 PM, Staff #1507 stated that the QRNs were expected to follow the policy and notify the attending provider within 30 minutes of all face to face assessments.

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