HospitalInspections.org

Based on interview and record review, the facility failed to provide informed consent to one patient when the physician failed to educate Patient 1 on Haldol (a drug that effects the brain and has serious side effects). This had the potential to violate Patient 1's right to be fully informed of medical care.

Findings:

During an interview with the Compliance officer on 4/15/13, at 2:34 PM, she stated she did not know about informed consent and she would have to ask someone about it.

During an interview with the ICU manager on 4/15/13, at 2:26 PM, she stated they do not do informed consent and she was not aware that they needed to have informed consent for psychoactive medications.

During an interview with the Director of Pharmacy on 4/15/13, at 2:50 PM, he stated Haldol had a blackbox warning (a warning indicating very serious side effects) which should have been addressed with Patient 1.

During an interview with the Director of Quality, Compliance Officer and the Director of Patient Care Services on 4/16/13, at 3:10 PM, they all reviewed the clinical record and were unable to find documentation of the physician giving informed consent or documenting Haldol was given without consent for an Emergency Exception (applies when a patient lacks capacity to make a healthcare decision and treatment is immediately necessary to prevent death or permanent disability).

The facility policy and procedure titled "Informed Consent" dated 11/12, read "...informed consent will be obtained as required by law, and consistent with the special legal requirements set forth in the CHA (California Hospital Association) for the following procedures:...Use of psychotropic medications...The patient's physician is responsible for providing the information the patient needs in order to make an informed decision and for obtaining the patient's informed consent or refusal...The hospital's role...is to verify that the physician obtained the patient's informed consent...or that an exception (such as the Emergency Exception) applies..."

The California Hospital Association Consent Manual, 2012, read "A voluntary patient may be treated with antipsychotic medications only after being informed of the right to accept or refuse the medications...The facility must maintain a written record of each voluntary patient's decision to consent...must be a written consent form signed by the patient..."