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300 PASTEUR DRIVE

STANFORD, CA 94305

PATIENT RIGHTS: INFORMED CONSENT

Tag No.: A0131

Based on interview and record review and hospital failed to inform a patient regarding an error in inserting a colonoscope (long flexible tube with a camera and light used to examine the large colon bowel) and taking biopsies (tissues) on the wrong site for one of four patients who underwent colonoscopy procedures in accordance with hospital policy (Patient 2). This failure had the potential to cause patient concern (i.e. pain from an unexpected area), additional discomfort and a missed opportunity for the patient to ask questions.

Findings:

Review of Patient 2's Progress Note, dated 6/27/25 at 10:47 a.m., indicated a physician had inserted the colonoscope into the patient's vagina instead of the rectum. While the scope was incorrectly positioned, biopsies and specimens were obtained under the mistaken belief the scope was appropriately placed.

Review of Patient 2's record on 7/8/25 at 2 p.m. did not contain documentation the patient was informed of the mistake.

During an interview on 7/8/25 at 2:06 p.m., the Attending Physician (AP, doctor who is responsible for the overall care of patient) recalled the surgical fellow (SF, physician in training) had trouble advancing the scope, biopsies were taken and the mistake of placing it into the wrong location was identified. The AP stated nurses should inform the patient and he in addition instructed the SF to speak to the patient about the mistake.

During an interview on 7/10/25 at 11:42 a.m. Physician B (Phy B) stated when a mistake occurred the physician should have informed the patient.

Review of the Unanticipated Outcomes - Disclosure policy, dated 02/2025, indicated to select a appropriate treating team or staff member to have a disclosure dialogue with the patient. Often, the physician guiding current and future care is the most appropriate. The policy further indicated to document the date of disclosure, who you communicated with, content of discussion and questions addressed.

PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT

Tag No.: A0145

Based on interview and record review the hospital failed to timely report an allegation of staff sexual abuse to a patient when management staff were informed by a nursing asssistant (NA) for one of one sampled patient (Patient 1). The hospital did not report to the Adult Protective Services (APS) or local law enforcement and did not timely report (within five days) to the California Department of Public Health (CDPH) in accordance with hospital policies. This failure resulted in the lack of or late investigations and to not take potential further actions by the respective departments.

Findings:

Review of Patient 1's record indicated the patient was admitted on 5/32/25 and discharged from the hospital on 5/26/25.

During an interview on 7/8/25 at 2:41 p.m., the NA D stated she witnessed in the morning registered nurse (RN) E stating to Patient 1 that he was the captain of the cruise ship, you do not tell the captain what to do and you had to listen. Patient 1 then stated she was just trying to figure out who was taking out a meal tray.

During the same interview on 7/8/24 at 2:41 p.m., NA D stated later the same day she witnessed RN D during hygiene care cupping Patient 1's breast, holding it and asked the patient if she had a breast implant. NA D stated she did not report the incident to a management staff the same day because the staff member was not there.

During an interview on 7/8/25 at 12:16 p.m., the senior director of quality management and regulatory affairs (SDQMRA) stated Patient 1 did not complain to the organization, we heard it from a staff member. If the patient had complained the incident would have been reported to CDPH immediately.

During an interview on 7/8/24 at 1:37 p.m., the director of service excellence (DSE) stated staff should immediately report abuse incidents, the incident occurred on 5/24/25 and the NA reported the incident on 5/28/25, RN D was terminated on 6/20/25 and the incident was reported to CDPH on 6/23/25. The DSE stated in hindsight the incident should have been reported to CDPH earlier.

During an interview on 7/10/24 at 3:03 p.m., the Director of Security Services (DSS) stated the incident by definition was classified as sexual assault, the team had a huddle and discussed the incident and did not report it to APS or local law enforcement.

Review of the Abuse and Neglect Reporting Procedures policy, dated March 2023, indicated all licensed staff who have observed, have knowledge of an incident that reasonably appeared to be abuse were mandated to provide an immediate telephone report and written report to Adult Protective Services or local law enforcement.

The Reporting Adverse Patint Event To Regulatory policy, dated July 2022, indicated the hospital was required to report adverse events to CDPH no later than five days after the adverse event had been detected and it referenced to Abuse and Neglect Reporting Procedures.

OPERATING ROOM POLICIES

Tag No.: A0951

Based on interview and record review the hospital failed to perform a complete time out (immediate pre-procedure pause by the entire team or the individual to confirm the correct patient, procedure and site) by not including a physician who initiated the colonoscopy (medical procedure to examine the large intestine using a thin, flexible tube) for one of four sampled patients who underwent colonoscopies (Patient 2). This failure had the risk to result in wrong site procedure.

The facility also failed to ensure a registered nurse (RN) had evaluated a patient's status as part of post colonoscopy discharge criteria for one of four sampled patients who underwent colonoscopies (Patient 2). This failure placed the patient at health risk and could not been sufficiently recovered from the procedure.

Findings:

1. Review of Patient 2's Progress Note, dated 6/27/25 at 10:47 a.m., indicated a Surgical Fellow (SF, physician in training) had inserted the colonoscope (long flexible tube with a camera and light used to examine the large colon bowel) into the patient's vagina instead of the anus. It indicated while the scope was incorrectly positioned, biopsies and specimens were obtained under the mistaken belief the scope was appropriately placed.

Review of Patient 2's Timeout form, dated 6/27/25 at 8:40 a.m., indicated the attending physician, anesthesiologist, registered nurse, were in attendance and indicated none others were present. The SF was not included in the time out.

During an interview on 7/10/25 at 12:10 p.m., registered nurse (RN) B stated everyone present for a case was to be included in time out, especially anyone touching the patient.

Review of the Universal Protocol policy, dated July 2022, indicated all immediate members of the procedure team were to participate in the time out process. Participation required that all team members were attentive and all activity ceased for the duration. Components of time out included correct procedure and correct site were required to be verified.

2. Review of the Endoscopy (medical procedure to examine intestines) Post Procedure form, under Discharge Status had patient discharge parameters including presence of active bleeding, awake or easily aroused, able to ambulate (walk), discharge teaching complete, and patient had transportation home accompanied by a responsible adult.

Review of Patient 2's Discharge Status of the Post Procedure form was not completed.

During an interview on 7/15/25 at 3:03 p.m., registered nurse (RN) C stated Patient 2 informed her she was ready to go home and the patient's discharge instruction consisted of informing the patient to call if any questions arose. The RN C stated she forgot to document in Patient 2's discharge status and acknowledged that was a part of the discharge criteria.

The policy addressing post procedure discharge was requested and not provided by 7/18/25.