HospitalInspections.org

Based on interview and record review, the facility failed to have a properly executed informed consent form (a legal voluntary agreement to accept treatment and/or procedures after receiving education regarding the risks, benefits, and alternatives offered) for 1 out of 30 sampled patients (Patient 6) when Patient 6 underwent a planned Cesarean section (C-section, a surgical procedure in which an incision is made on the abdomen to deliver a baby), yet their consent form had the incorrect responsible physician and did not have a witness signature (a signature made by someone who is responsible for observing the patient sign a legal document).

This failure has the potential for a loss of patients' rights and possible harm.


Findings:

A review of Patient 6's Labor and Delivery (L&D) note (a summary of how a patient delivers a baby in a hospital) written by Medical Doctor (MD) 1, dated 08/02/25, indicated Patient 6 "was admitted on 08/02/2025 for scheduled repeat c-section." The note further indicated a list of surgeons involved in the procedure: MD 1 as "primary" surgeon, MD 2 as "assisting" surgeon, and MD 3 as "Supervising Surgeon."

A review of Patient 6's Operating Room Audit Log (a summary of events before, during, and after a surgical procedure), dated 08/02/25, indicated a panel of surgeons in the room as MD 1, MD 2, and MD 3. In addition, the audit log indicated Registered Nurse (RN) 1 as the primary circulating nurse (a nurse responsible for coordinating patient care during surgical procedures) for the procedure.

During a concurrent interview and record review on 08/06/25 at 2:37 PM with RN 1, Patient 6's informed consent form titled "Consent for Operation, Anesthesia [intervention that temporarily block pain/sensation during a procedure], Procedures, and Medical Services", dated 08/02/25, was reviewed. Patient 6's informed consent form indicated the agreement was to "have the following operation or procedure: CESAREAN SECTION ...The responsible surgeon is: [MD 4]". The informed consent form further indicated, "My doctor [MD 4] has explained to me: what the operation or procedure and anesthesia will be like. We have also talked about the purpose, risks, benefits, and alternatives to the procedure and plan of care ...I give my consent for this procedure. I authorize the above named surgeon(s) to: Preform the above-described operation or procedure as well as any additional services which are considered needed to treat or correct conditions ..." The informed consent form was signed by Patient 6, but the witness signature was left blank. RN 1 stated that it is important for a signature to be witnessed because "it's to confirm that it's not a falsified signature ... and that a medical provider has provided informed consent." RN 1 acknowledged the missing witness signature on Patient 6's informed consent form stating, "it should be witnessed ...that was certainly missed."

During a concurrent interview and record review on 08/06/25 at 3:17 PM with MD 1, Patient 6's informed consent form titled "Consent for Operation, Anesthesia, Procedures, and Medical Services", dated 08/02/25, was reviewed. Patient 6's informed consent form had a blank witness signature line and indicated MD 4 as the surgeon responsible for the C-Section. MD 1 stated that the "supervising attending" physician (a fully licensed and trained MD who has completed residency and is responsible for the overall care of a patient in a hospital) would be the named responsible surgeon on an informed consent form. MD 1 stated she was the primary surgeon for Patient 6's c-section on 08/02/25 and she was supervised by MD 3; MD 1 acknowledged that MD 3's name was not the documented responsible surgeon on the consent form stating, "we usually reprint [the consent form]" if the responsible surgeon changes ... "and it was missed". MD 1 further stated that a nurse will witness the signature by a patient "to make sure they [the patient] were the one that did it [signed the form]."

During a concurrent interview and record review on 08/07/25 9:47 AM with Nurse Manager (NM) 1, Patient 6's informed consent form titled "Consent for Operation, Anesthesia, Procedures, and Medical Services", dated 08/02/25, was reviewed. Patient 6's informed consent form had a blank witness signature line and indicated MD 4 as the surgeon responsible for the C-Section. NM 1 stated she is the nurse manager for the post-partum unit (part of hospital where new parents and their babies receive care right after delivery), but she covers for the labor and delivery unit if the regular NM is off. NM 1 stated that a nurse will usually witness a singed consent form "to make sure that the physician has reviewed [the consent] with the patient and has been able to answer the clarifying questions." NM 1 reviewed the blank witness signature line and was asked if this was consistent with expectations for a completed consent form; NM 1 stated, "absolutely not ... no." When asked if the name of the responsible doctor on the consent form should match the doctor that was present in the operating room, NM 1 stated affirmatively, "mhm ... because it would be clear that they [the doctor] would be taking ownership and following them [the patient] to the OR."

A review of facility policy and procedure (P&P) titled, "Consent NCAL Regional Policy", approved on March 2024, indicated "The consent process provides an opportunity to establish a mutual understanding between the patient and the physician or Allied Health Practitioner (AHP) about the care, treatment, and services that the patient will receive. Consent is a process that considers the patient rights and preferences, compliance with law and regulation, and patient education. The use of the consent process helps the patient to participate fully in decisions about their care, treatment, and services ...A discussion between the patient ... and the Physician or AHP is the most important part of the informed consent process and will include the following: ... Identify by name and profession the Physician/AHP who has primary responsibility for the treatment or procedure ...Obtaining the Patient Signature: ... The witness is expected only to confirm that they were present when the form is singed by the patient ... and should indicate that they witnessed the singing by placing their signature in the designated space on the form, including date and time ..."