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1220 MISSOURI AVE

JEFFERSONVILLE, IN 47130

PATIENT RIGHTS: INFORMED CONSENT

Tag No.: A0131

Based on document review and interview, the hospital failed to ensure for patient rights of informed consent for 1 of 10 patients (P2).

Findings include:

1. Review of the policy titled Patient Rights and Responsibilities, PolicyStat ID: 6613524, last approved 7/2019, indicated patients have the right to the following:
Obtain from physicians...current and understandable information concerning diagnosis, treatment and prognosis.
Make informed decisions about the plan of care prior to and during the course of treatment and to refuse a recommended treatment plan or plan of care...an be informed of the medical consequences of this action...
Have an Advanced Directive (such as a...Health Care Proxy or Durable Power of Attorney for Health Care) concerning treatment or designating a surrogate decision maker...

2. Review of the Medical Staff Bylaws, approved 8/2016, indicated that the following:
The patient shall be provided with pertinent information regarding outcomes of diagnostic tests, medical treatment and surgical intervention.
The Attending Physician shall keep the patient and the patient's family informed concerning the patient's condition...

3. The MR of patient P2 indicated the following: The patient presented to the ED on 3/24/21, was admitted to the hospital's Behavioral Health Unit (BH/BHU) and discharged back to his/her previous living at a memory care facility. MR documentation indicated G1 was the legal guardian of P2. The MR indicated the patient was admitted with a chief complaint of confusion, was noted to have a UTI (urinary tract infection) and had diagnoses that included dementia. The Medication reconciliation (Med Rec) record dated 3/25/21 by Physician Assistant AH1 lacked documentation of the patient having been on antipsychotic medications prior to admission. The MR indicated the antipsychotic medication Quetiapine (Seroquel) was ordered by by AH1 beginning on 3/31/21 with a 25mg dose and continually increased to a 100mg dose. The MR lacked documentation of physician rationale for use of the medication with a dementia patient and lacked documentation of the physician having discussed the risks and benefits for use of the antipsychotic with the patient's legal guardian in order to make an informed decision

4. Review of the package insert for Quetiapine (Seroquel) at https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020639s064lbl.pdf indicated the following:
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS
WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL
THOUGHTS AND BEHAVIORS.
See full prescribing information for complete boxed warning.
Increased Mortality in Elderly Patients with Dementia-Related
Psychosis
- Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. SEROQUEL is not approved for elderly patients with dementia-related
psychosis (5.1)

5. On 5/5/21, beginning at approximately 6:00 PM, A9, Chief Medical Officer, when discussing use of antipsychotic medications, specifically Seroquel, for patients with dementia, indicated that a physician may use medications that are black labeled [not approved by FDA (Food and Drug Administration)] for certain uses so long as the physician discusses the risks and benefits (gives justification) with the patient so that the patient may make an informed decision.

On 5/5/21, beginning at approximately 6:00 PM, A10, Director of Pharmacy, certain antipsychotic medications did have an "alert" in their computer system. A10 indicated the alert/warning included antipsychotic medications Seroquel and Geodon.

DISCHARGE PLANNING- TRANSMISSION INFORMATION

Tag No.: A0813

Based on document review and interview the hospital failed to ensure medical information pertaining to the patient's course of illness and treatment, post-discharge goals and treatment preferences were provided to 4 of 4 patients (P2, P3, P4 and P7) who had a legal guardian/patient representative/Power of Attorney (POA).

Findings include:

1. Review of the Medical Staff Bylaws, approved 8/2016, indicated that the following:
The Attending Physician and hospital staff shall ensure that the patient (or appropriate family member or legally designated representative) is provided with information that includes, but is not limited to:
Written discharge instructions in a form and manner that the patient or family member can understand.

2. Medical record (MR) review indicated the following:
The MR of patient P2 indicated that on 3/24/21 P2 was admitted to the hospital's Behavioral Health Unit (BH/BHU) and discharged back to his/her previous living at a memory care facility on 4/13/21. The MR indicated G1 was the legal guardian of P2. The MR lacked documentation of the patient's guardian, G1, having been provided discharge instructions on behalf of the patient.

The MR of patient P3 indicated the patient was admitted 3/26/21 and discharged 4/2/21. The MR indicated G2 was Power of Attorney for P3. The patient education log indicated education material was given to the patient verbally; Outcome: Unable to comprehend. Discharge instructions indicated the patient was unable to sign. The MR lacked documentation of G2 having been provided discharge instructions on behalf of the patient.

The MR of patient P4 indicated the patient was admitted 3/31/21 and discharged 4/6/21. The MR indicated G3 was Power of Attorney for P4. The MR lacked documentation of G3 having been provided discharge instructions on behalf of the patient.

The MR of patient P7 indicated the patient was admitted 3/9/21 and discharged 3/18/21. The MR indicated G4 was Power of Attorney for P7. Discharge instructions indicated the patient had dementia and was unable to sign. The MR lacked documentation of G4 having been provided discharge instructions on behalf of the patient.

3. On 5/5/21, beginning at approximately 4:45 PM, A6, Behavioral Health Director, verified lack of MR documentation of discharge instructions having been provided to legal representatives as indicated above.