HospitalInspections.org

Based on review of documentation and interview, it was determined that the facility failed to receive informed consent for a surgical procedure performed on Patient # 1.

Findings were:

Facility policy entitled "Consent for Treatment" stated in part:
"A. Patients of Abilene Regional Medical Center shall receive from their physician information necessary to give informed consent prior to the initiation of any procedure and/or treatment. Except in emergencies, such information for informed consent should include but is not necessarily limited to:
1. Informing of the possible risks and hazards involved in the medical treatment and/or surgical procedure
2. Giving opportunities to ask questions about their condition
3. Discussing alternative forms of anesthesia and treatment
4. Risks of non-treatment
B. This information includes the identity of the physician/practitioner with the primary responsibility for the patient's care, and the identity and professional status of individuals responsible for authorizing and performing procedures or treatments. Information should be communicated to patients in a language to patients in a language which he/she can comprehend. In cases where it is not medically advisable to give information to the patients, the information may be available to appropriate persons on his/her behalf.
C. In accordance with state and federal law, prior to providing care, treatment or services, consent will be obtained from either the patient or the patient's surrogate decision maker ...
E. In emergent situations where immediate medical action is necessary to preserve the life of the patient or prevent a possible permanent impairment of the patient's health, consent is not mandatory, if it is not reasonably obtainable. In such an event, the physician shall sign a statement noting in the Medical record that delay in the provision of medical care may endanger the life of the patient or cause permanent health impairment.

DEFINITIONS:
F. Informed Consent: is an ongoing and interactive process in which adult patients and/or, when appropriate, patients' families or designated surrogates receive from their physician information necessary for the reasonable patient to make a decision to proceed or refuse care or a prescribed course of treatment.
G. Implied Consent: occurs if a patient, minor or adult, is injured or ill to the extent of rendering the patient unconscious or unable to consent to medical treatments, procedures, or care and their condition requires prompt medical attention, consent by the patient is implied and no formal authorization is necessary. Implied consent also exists in situations where a physician discovers conditions not anticipated after surgery has commenced. The physician's professional judgment must prevail when immediate action is advisable for the patient's welfare. Implied consent exists only during the immediate emergency."

Facility document entitled "Notice of Patient Rights and Responsibilities" stated in part "You have the right to:
* Participate in decisions about your care, including developing your treatment plan, discharge planning and having your personal physician promptly notified of your admission ...
* Refuse care, treatment or services in accordance with law and regulation and to leave the facility against advice of the physician.
* Have a surrogate decision-maker participate in care, treatment and services decisions when you are unable to make your own decisions ...
* Give or withhold informed consent when making decisions about your care, treatment and services."

On June 1, 2018, Patient # 1 presented to the Emergency Department of Abilene Regional Medical Center via ambulance with her husband-both complaining of nausea and vomiting. The ED doctor administered an EKG, which Patient # 1 claimed she did not want. The patient was told the EKG revealed a cardiac infarction and the cardiologist said that she needed a heart catheterization. Patient # 1 claims she told the cardiologist that she did not want this procedure but he did not listen. She did not sign the consent for treatment. Patient # 1's spouse was present but the procedure was not explained to him nor did he give consent.

In an interview with the Director of the Cath Lab on October 31, 2018, it was asserted that the event was emergent and "implied consent" was given. It was admitted that even though the patient's husband was present, he was not asked to sign informed consent of the surgical procedure.

Based on document review and interview, it was determined that the facility failed to have properly executed informed consents in all of its medical records.

Findings were:

Facility policy entitled "Consent for Treatment" stated in part:
G. Implied Consent: occurs if a patient, minor or adult, is injured or ill to the extent of rendering the patient unconscious or unable to consent to medical treatments, procedures, or care and their condition requires prompt medical attention, consent by the patient is implied and no formal authorization is necessary. Implied consent also exists in situations where a physician discovers conditions not anticipated after surgery has commenced. The physician's professional judgment must prevail when immediate action is advisable for the patient's welfare. Implied consent exists only during the immediate emergency."

Facility document entitled "Notice of Patient Rights and Responsibilities" stated in part "You have the right to:
* Participate in decisions about your care, including developing your treatment plan, discharge planning and having your personal physician promptly notified of your admission ...
* Refuse care, treatment or services in accordance with law and regulation and to leave the facility against advice of the physician.
* Have a surrogate decision-maker participate in care, treatment and services decisions when you are unable to make your own decisions ...
* Give or withhold informed consent when making decisions about your care, treatment and services."

8 cardiac catheterization records were selected because EKGs revealed ST elevation (STEMI). 3 of 8 informed consent documents were not signed by the patient or patient representative (although there is documented evidence that family members were there in two of three instances.)

* Patient # 1 stated she did not want a cardiac catheterization and did not sign a consent for the procedure. The patient's husband was present and was not asked to give consent. The cardiac catheterization was deemed emergent with implied consent from the patient.
* Patient # 13's spouse signed all consents for treatment except for consent for the cardiac catheterization. The cardiac catheterization was deemed emergent with implied consent from the patient.
* Patient # 15 signed all consents for treatment except for consent for the cardiac catheterization. The cardiac catheterization was deemed emergent with implied consent from the patient.

In an interview with the Director of the Cath Lab on October 31, 2018, it was asserted that the above events were emergent and "implied consent" was given. It was admitted that even though the patient's family members were present in two cases, they were not asked to sign informed consent of the surgical procedure. It was acknowledged that patient # 15 was able to sign consents for treatment but did not sign the informed consent for the heart catheterization.