Rush University Medical Center

“PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) (a) Standard: Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities, The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ... (3) That clear expectations for safety are established. This Standard is not met as evidenced by: 34411 Based on document review and interview, it was determined that for 1 of 2 (Pt #5), clinical records reviewed for patients with postpartum hemorrhage, the Hospital failed to ensure that a safety event was initiated in order identify, track, and analyze adverse patient events. Findings include: 1. The Hospital’s Postpartum Hemorrhage Written Protocol (dated 9/16/2024), was reviewed and required, “ ...Reporting. b. Safety Event Reporting-Postpartum hemorrhage events should be reported via safety event. Safety event reporting is an objective notification to the department and hospital leadership team of events that occur outside of the standard of care.” 2. The clinical record for Pt #5 was reviewed on 2/17/2026. Pt #5 presented to the L&D (labor and delivery) on 12/7/2025, for a scheduled induction of labor. - Progress note (dated 12/17/2025 at 8:01 PM), documented by an Obstetrics/OB Resident (MD #22/co-signed by OB Attending MD #16), included, “ ...Patient had cervical balloon placed for IOL [induction of labor] and fetus was then found to be in breech position (fetus buttocks aimed toward birth canal and feet toward head). Balloon was immediately removed. Patient was counseled on options for ECV (external cephalic version/manually turning fetus) vs (versus) primary C-section (cesarean section/surgical procedure to delivery baby). Patient elected for C-section after considering options and discussion again with [MD #16] and myself.” - OR Timeline documented that the patient was brought in the OR on 12/17/2025 at 9:59 PM. A uterine incision was made on 12/17/2025 at 10:40 PM. Pt #5’s newborn was born on 12/17/2025 at 10:43 PM. Pt #5 was out of the OR on 12/18/2025 at 1:41 AM. - Operative Report (dated 12/17/2025 at 10:36 PM), included, “ ...Procedure: L &D Cesarean Section by low transverse incision type ...Hysterotomy [opening made into the uterus] with extensions downwards into the left aspect of the cervix (uterine opening) ...Bleeding left uterine artery and ascending branches of the uterine artery due to extensions disrupting the broad ligament ...Quantitative blood loss: 2397 ml [milliliters/approximately 2.4 liters]. Complications: Post Partum hemorrhage ...Description of Procedure ...it was noted that the patient was actively and heavily bleeding and a BLEED timeout [protocol for postpartum hemorrhage]. Tranexamic acid [medication given to stop bleeding] 1 gram was given IV. There was some uterine atony [failure of uterus to contract after birth] noted and hemabate IM [intramuscular] was given which resolved the atony. Stat labs [immediate] were obtained and pRBC and FFP (packed red blood cells and fresh frozen plasma/blood products) were obtained from blood bank ... Bleeding became controlled, and the uterus was carefully inspected ...” 3. The Incident/Safety event log from 12/1/2025-2/17/2025, was reviewed. There were no safety events related to Pt #5’s postpartum hemorrhage. According to the Hospital’s “Postpartum Hemorrhage Written Protocol”, a safety event should be completed for postpartum hemorrhages. There was no safety event completed for Pt #5’s postpartum hemorrhage that resulted in a 2,397 ml blood loss (greater than 1.5 L with c-section is considered a postpartum hemorrhage). 4. On 2/18/2026 at 9:41 AM, a phone interview was conducted with the OB Attending (MD #16). MD #16 stated that their was an extension with Pt. #5’s hysterotomy (cut into the uterus to make an opening). MD #16 stated that during the extension, a uterine artery was cut. MD #16 stated that there was bleeding that was occurring while the uterus was trying to be repaired. MD #16 stated that Pt #5 loss over 2 liters of blood and anything over 1 liter in a c-section, is considered a hemorrhage. MD #16 stated that there was no incident report done regarding Pt #5’s hemorrhage. 5. On 2/18/2026 at 10:13 AM, an interview was conducted with the L&D RN (E #18). E #18 stated that the delivery was complicated when they were trying to get the baby’s head out. E #18 stated that there was head entrapment. E #18 stated that there was excessive blood loss greater than 1 liter and a “BLEED Timeout” was called. E #18 stated that during a “BLEED Timeout”, the nurses and doctors go over blood loss, current state, what labs have been drawn and may need to be drawn, and if there is a need for more blood products. E #18 stated that Pt #5 received 2 units PRBCs (packed red blood cells) and 2 units FFP (fresh frozen plasma). E #18 stated that E#18 did not enter a safety event. 6. On 2/19/2026 at 10:18 AM, a phone interview was conducted with the L&D Charge RN (E #23). E #23 stated that E #23 was the Charge RN on 12/17/2025 (night shift 7p-7a). E #23 stated that, E #23 was made aware of complications with Pt #5 in the OR. E #23 stated that a safety event should be entered for a postpartum hemorrhage. E #23 stated that E #23 did not enter a safety event.”

“PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT CFR(s): 482.13(c)(3) The patient has the right to be free from all forms of abuse or harassment. This Standard is not met as evidenced by: 52901 Based on document review and interview, it was determined that for 1 of 1 (Pt#1) clinical record reviewed for allegation of abuse, the hospital failed to ensure the removal of the accused staff member, after the date of reported allegation, from patient care while the investigation was ongoing. Findings include: 1. The hospital’s policy titled, “ Investigation and Reporting of Allegations of Patient Abuse “ (approved 11/13/2023), was reviewed on 09/24/2025 and include,” When an allegation of patient abuse has been made, it is immediately reported to the HOA (Hospital Office Administrator) ...To secure the safety of the alleged victim and all other patients, the HOA has the authority to make decisions concerning the immediate role of the staff member alleged to have abused the patient ...to place them on an administrative leave or apply other appropriate measures needed to secure patient safety ... This is done to meet the regulatory requirements to ensure that patient safety is secured when an allegation of abuse has been made ...” 2. The clinical record for Pt#1 was reviewed on 09/23/2025. Pt#1 arrived at the Labor and Delivery triage on 06/22/2025 at 1:14 AM with complaints of abdominal pain and chills. The clinical record included the following: - The Registered Nurse (RN/E#5) note, dated 06/22/2025 at 5:05 PM (late entry), include” Pt#1 to radiology at 12:05 PM, returned to unit at 2:15 PM ... Pt#1 asked E#5 to accompany (Pt. #1) to the bathroom ...Pt#1 became emotional and reported, during (Pt#1) ultrasound exam, “(Pt#1) felt something rubbing on (Pt#1) leg, then felt something go inside (Pt#1) real quick ...splash down ... (Pt#1’s) leg ...Charge nurse notified of this information and HOA contacted. - MD Progress note, dated 06/22/2025 at 4:04 PM, include,” RN reports that Pt#1 sexually assaulted by the ultra-sonographer (operates ultrasound equipment)...contacted SANE (Sexual Assault Nurse Examiner) RN...” -Nurse note, dated 06/22/2025 at 4:53 PM, include,” SANE RN to bedside to further explain role, evidence collection, forensic exam and reporting options to CPD (Chicago Police Department).” 3. The hospital’s “Summary Report of Investigation” and “Addendum to Summary Report of Investigation” was reviewed on 09/24/2025. These reports include the following: The background and factual summary of the reported event and the investigation, by OIE (Office of Institutional Equity), that was conducted through interviews with Pt#1 and E#4. The report include,” HOA spoke with E#4 to inform of the complaint ... to remove from patient care duties pending outcome of investigation ... E#4 reported to HOA that Pt#1 touched E#4 inappropriately.” On 07/10/2025, E#4 shared with OIE new information that altered the initial understanding of the timeline of events and the new badge entry data that was obtained from [Hospital’s] security. This obtained data allowed for a new timeline to be created that was based on information obtained from EPIC, Badge Data, Patient Transport Department and Viewpoint. The outcome of the investigation resulted in being “inconclusive” based on E#4’s account of events not matching with the new timeline established by the data and E#4 failing to report incident. 4. The hospital’s “Ultrasound Schedule”, dated June 15, 2025- July 5, 2025, was reviewed on 09/24/2025 and include the following scheduled days for E#4: June 27, 2025, 7:30 AM- 6:30 PM, June 28, 2025, 6:00 AM - 7:00 PM, June 29, 2025, 6:00 AM - 7:00 PM and July 5, 2025, 6:00 AM - 6:30 PM. E#4 was allowed to work while the investigation was ongoing following the reported allegation of sexual assault. 5. The hospital’s Ultrasound Patient Schedule for 06/27/25 to 06/29/25 were reviewed. The log indicated that E#4 conducted a Transvaginal Ultrasound on a patient (Pt.#13) on 06/28/25 at 3:15 PM. 6. An interview was conducted with Ultrasound Supervisor (E#3) on 09/24/2025 at approximately 11:27 AM. E#3 stated that (E#3) received a call from E#4, while (E#3) was at home, on 06/22/2025. E#3 stated that E#4 informed (E#3) of the allegation but did not go much into details at that time. E#3 stated that when (E#3) returned to work that Tuesday, which was 06/ 24/2025, that was when E#3 was able to gain more insight with the allegation. E#3 stated that (E#4) did leave (E#4) shift on that day the allegation was reported which was 06/22/2025. E#3 stated that it is very hard to staff for the weekends and that E#4 was the designated weekend staff member. E#3 stated that because of the short staffing and how hard it is to get staff for the weekends, E#4 was allowed to work while the investigation was ongoing. E#3 stated that E#4 worked on the following dates, June 27th -29th, using an authorized “Buddy/Supervision System” by HR (Human Resource). E#3 stated that E#4 was paired with a student for those scheduled shifts. E#3 stated as the investigation continued, (E#4) was placed on administrative leave as of July 3rd. E#3 stated that E#4 did not return to work after July 3rd. E#3 stated that there is a standard practice, in place, for female chaperones to assist male technicians when performing female endocavity (inside/ internal body) exams. E#3 stated that in this case (Pt#1) was receiving a transabdominal ultrasound and that exam does not require for another female to be present in the room. Additionally, E#3 stated that there has been a newly drafted policy titled, “Ultrasound Buddy/Chaperone System” that was created about a month after the incident. In this policy, it outlines when to use a buddy/chaperone, the eligible chaperones, roles of buddy/chaperone and the documentation and reporting. 7. An interview was conducted with Senior Director of Diagnostic Services (E#15) on 09/24/2025 at approximately 3:20PM. E#15 stated that the weekends are hard to staff, therefore, E#4 remained on the schedule, for June 27-29, due to it not being enough evidence, at the time, the allegation was reported. E#15 stated that an ultrasound student was paired with E#4, during that time, to ensure that E#4 was not alone with a patient. E#15 stated that as the investigation continued, E#4 was removed placed on “administrative leave” and eventually terminated from his position.”

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 48264 Based on document review and interview, for 1 of 3 patients’ (Pt. #2) clinical records reviewed for post-fall assessments, the hospital failed to ensure that the registered nurse conducted vital signs and confirmed family notification by physician post-fall. Findings include: 1. On 9/23/2025, the hospital’s ‘Post-Fall Huddle’ reference document was reviewed and included, “The purpose of the Post-Fall Huddle is to clearly identify the event objectively and offer valuable insight on how to prevent future occurrences ...When: Immediately after a fall once the patient has been assessed and is medically stable ...Who fills out the Post-Fall Huddle Form: RN assigned to patient/ and or Charge RN along with witness, if applicable ...Post-Fall Checklist: immediately notify provider ...assess the patient for any signs of injury, perform appropriate post-fall monitoring (vital signs, glucose (blood sugar), neuro checks) ...Reassess Morse Fall Scale (method used to assess a patient’s risk of falling) ...Complete a progress note ...Complete TRIPPS (Tracking Risks, Incidents, Performance and Safety across the System/Safety Event) report and Post-Fall Huddle Form ...”. 2. On 9/23/2025, the clinical record of Pt. #2 was reviewed and indicated that on 6/28/2025, Pt. #2 presented to the hospital as an outside hospital (OSH) transfer after sudden-onset seizures, found to have a large traumatic subdural hemorrhage (bleeding inside the brain caused by injury) and was admitted for surgical intervention and neurological (related to the nervous system- brain, spinal cord and nerves) monitoring. The clinical record included the following: -The Registered Nurse’s (E #13) ‘Progress Note’ on 7/13/2025 at 5:11 PM included, “ ...Bed alarm alarming overhead. [Pt. #2] found leaning against the bed in upright position with knees on the floor. Staff assist called. MD (physician) came to bedside, and [Pt. #2] transferred back to bed ...Neuro assessment and adult assessment completed. No neuro change ...[E #13] reviewed fall prevention measures with [Pt. #2] and reviewed how to call for staff assistance. Fall huddle form and Safety Event Form completed ...[Pt. #2] verbalized understanding, call light within reach”. -The ‘Post Fall Huddle Form (undated)’ was completed and included, “ ...[Pt. #2] ...Primary RN: [E #13] ...Staff who witnessed the fall: none ...Was the unit appropriately staffed according to their staffing grid at the time of the fall?: Yes ...Describe the event as it occurred: Bed alarm alarming overhead. RN went to room and found [Pt. #2] down leaning against the bed with knees on the floor. [Pt. #2] stated [Pt. #2] was trying to answer the phone ...Post fall checklist: Notify Charge RN; Notify Provider; Document Post Fall (head to toe) assessment in medical record; Document progress note; Complete a safety event in TRIPPS; Communicate patient fall with staff ...”. The post fall huddle did not indicate that Pt. #2’s family was notified of the fall. -On 7/13/25 at 5:45 PM, the ‘Vitals Signs flowsheet” included, that Pt. #2’s heart rate was 103 (reference range: 60-100) and respirations: 21 (12-20). The flowsheet did not include a complete set of vitals post-fall. 3. On 9/24/2025, at approximately 10:50 AM, an interview with the Clinical Manager of Inpatient Physical Therapy/Fall Oversight Committee (E #11), the Vice President of Patient Care Services/Fall Oversight Committee (E #12) and the Accreditation Manager (E #20) was conducted. E #11 and E #12 stated that the Hospital does not have a post-fall policy, and the clinical staff are to follow the ‘Post-Fall Huddle’ reference document and complete the components of the Post-Fall Checklist. After review of Pt. #2’s medical record, E #11, E #12, and E #20 confirmed the record lacked family notification and vital signs documentation post-fall.”

“EMERGENCY SERVICES POLICIES CFR(s): 482.55(a)(3) [If emergency services are provided at the hospital --] (3) The policies and procedures governing medical care provided in the emergency service or department are established by and are a continuing responsibility of the medical staff. This Standard is not met as evidenced by: 40079 Based on document review and interview, it was determined that for 1 of 3 patients’ (Pt. #2) self-harm events reviewed for reporting and follow up, the hospital failed to ensure a self-harm event was reported, as required. Findings include: 1. The hospital’s policy titled, “Safety Event and Medical Device Reporting” (updated 02/07/22) was reviewed and required, “ ... 4. A Safety Event is completed for events involving patients ... and included, r. Self-harm events ... III. Procedure 1. Complete safety event at time of event ... “ 2. The hospital’s Safety Event (self-inflicted injury) log (05/2024 - 11/06/2024) was reviewed. The log did not include an event for (Pt.#2). 3. The clinical record for Pt.#2 was reviewed. Pt.#2 presented to the Emergency Department (ED) as a walk-in on 07/04/24 at 9:31 AM and was discharged to home on 07/06/24 at 12:34 PM. The clinical record included the following: -Nursing Note (E#8), dated 07/06/24 at 12:30 PM, “(Pt.#2) refused care from RN (Registered Nurse), (Pt.#2) notified of DC (discharge) plan by psychiatry. (Pt.#2) observed attempting to hurt self with pitcher top, also observed picking on scabs to bleed, used bed sheet to strangle self. MD notified ... (Pt.#2) stated feeling agitated, PRN (as needed) meds (medication) administered, DC (discharge) papers given to (Pt.#2). DC to self at this time ... security assisting pt out.” 4. An interview was conducted with a Registered Nurse (E#8) on 11/07/24 at 10:35 AM. E#8 stated that E#8 did not file a safety event report for the self-harming event by (Pt.#2). 5. An interview was conducted with the Emergency Department Director (E#15) on 11/07/24 at 12:10 PM. E#15 stated that incidents involving patients inflicting self-harm should be reported as a safety event.”