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Tag No.: A0131
Based on interview and record review, the facility failed to obtain a consent for treatment for three patients (P-4, 5 and 9) of 10 patients reviewed resulting in loss of informed consent and possible negative outcomes to the patients. Findings include:
During medical record review on 6/09/25 record of P-4 revealed that patient was a 36-year-old female admitted to facility on 4/18/25 with diagnosis of debility and fatigue post sepsis (serious condition that occurs when the body has an extreme reaction to an infection, leading to widespread inflammation and potential organ dysfunction) due to aspiration pneumonia (a lung infection that occurs when foreign materials, such as food or vomit, are inhaled into the lungs, specifically in the lower respiratory tract). Patient was treated in the facility and discharged home on 5/09/25. Upon review, no consent for treatment in the facility, signed by patient or her responsible party, was identified in the patient's record.
Review of P-5 record revealed that patient was a 56-year-old female admitted to facility on 4/21/25 with diagnosis of brain injury status post craniotomy (a type of brain surgery where a surgeon removes part of the skull to access the brain) for tumor resection. Patient was treated in the facility and discharged on 5/06/25. Upon review, no consent for treatment in the facility, signed by patient or her responsible party, was identified in the patient's record.
Review of P-9's record revealed the patient was a 90-year-old female admitted to the facility on 5/19/25 with diagnosis of CVA (cerebrovascular accident or stroke, which is a medical emergency that happens when something prevents the brain from getting enough blood flow). Patient was treated in the facility and transferred to another acute care facility on 6/03/25. Upon review no consent for treatment in the facility, signed by patient or her responsible party, was identified in the patient's record.
On 6/09/25 at 1317 during interview with Manager of patient access, Staff L, she explained that consent for treatment is usually signed on admission. If patient unable to sign, then staff will attempt to contact next of kin or responsible party. In cases when no one is available to sign for the patient on admission, case managers or social workers will attempt to locate family or responsible party during patient's stay.
On 6/10/25 at 1555 during interview with facility Chief nursing officer, Staff C, she stated the facility was not able to locate signed consents for treatment for P-4, 5 and 9. She added that there was a documentation that P-5 and P-9 were not able to sign their consents on admission. However, she was not able to provide details why consents were not signed later with responsible parties or patients' representatives (who were listed in patients' records).
Facility policy for consent for treatment was requested and a "General consent for admission and treatment" form was provided. Consent form indicated "Consent: I consent to routine medical, nursing care, diagnostic procedures, drugs and therapeutic treatments as are deemed necessary by my providers". Form contained detailed information regarding care in the facility, provision of services, outlined release of information, noted advanced directives, privacy practice, smoking rules and personal property. There was a statement below the outlined information: "Photostatic copies of this agreement and the signatures below shall be considered the same as the original. I have read this form. It has been fully explained to me, and all my questions about this form have been answered. I understand its' contents". There was a signature box for patient or patient representative to sign, witness box, and boxes for date and time. On the bottom it was indicated that white copy needs to be placed in a medical record (of the patient) and yellow copy given to the patient.
Facility "Patient Rights and Responsibilities" policy dated 2/10/22 was reviewed and revealed:
"Policy. Each health care facility within the [corporation name] has the responsibility to ensure the rights of all patients and, if applicable, their parents/guardians, to participate in decisions regarding their medical care. Patient rights and responsibilities shall be posted and given to the patient at admission or as soon as reasonably possible.
A. Patient Rights Include:
2. Patients will be informed about their illness, the status of their condition, prospects for recovery, treatment plan, and any medical alternatives and choices. This information will be shared with the patient by the physician, his/her representative, or other staff. If patients are unable to communicate or make decisions, the information will be shared with the person acting on their behalf.
9. Patients, in order to give consent, will receive the information necessary from their physician about their medical plan of care, how a procedure is to be done, who will do the procedure/treatment and what to expect prior to the beginning of a procedure/treatment. In an emergency, treatment may come first and explanations given later.
10. Patients may refuse any or further treatment. For those patients who decide to refuse treatment, the alternatives will be explained carefully so that the patient understands the risks, consequences, possible pain, and how the decision may affect their health."
Facility policy "Informed Consent for Medical/Surgical Treatment, and Diagnostic Procedure" dated 11/26/20 was reviewed and revealed:
"Objective. To establish a consistent policy, applicable to all [corporation name] Operating units, regarding consent for treatment.
Policy. Capable adults patients have the right to self-determination regarding medical treatment, and the right to information necessary to make an informed choice among available medical alternatives. An incapable patient's surrogate decision-maker has the same rights to information as the patient would if he were capable".