Advocate Illinois Masonic Medical Center

“SURGICAL SERVICES CFR(s): 482.51 If the hospital provides surgical services, the services must be well organized and provided in accordance with acceptable standards of practice. If outpatient surgical services are offered the services must be consistent in quality with inpatient care in accordance with the complexity of services offered. This Condition is not met as evidenced by: 30461 Based on document review, and interview, it was determined that the hospital failed to comply with the Condition of Participation, 42 CFR 482.51 Surgical Services. Findings include: 1. The hospital failed to ensure that the required resources were available prior to taking patient to the operating room and inducing anesthesia, per hospital policy. See A-951.”

“OPERATING ROOM POLICIES CFR(s): 482.51(b) Surgical services must be consistent with needs and resources. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care. This Standard is not met as evidenced by: 30461 Based on document review and interview it was determined that for 1 (Pt. #2) of five patients medical record reviewed for surgery, the hospital failed to ensure that the required materials for the surgical procuedure were readily available prior to taking patient to the operating room and inducing anesthesia, per hospital policy. Findings include: 1. On 6/11/2025, the hospital’s ‘Loaner Tray’ (template 4/12/2023 B.) policy included, “ ...III. Definitions: ...Loaner Trays: surgical instruments/implants that are not owned or housed in [hospital] ...IV. Policy: ...All loaner instruments must be received, logged, decontaminated, and sterilized in the sterile processing department (SPD) prior to scheduled procedure ...1. ...trays shall arrive at the site for validation by 9:00 a.m., no less than 48 hours prior to the day before the scheduled procedure ...”. The hospital reviewed the policy on 10/22/2024, however no revisions were made. 2. On 6/11/2025, the hospital’s ‘Universal Protocol for Procedural Safety’ (10/24/2022) policy included, “ ...V. Procedure: A. Pre-procedure verification process ...5. The elements of pre-procedure verification may include but is not limited to: ...e. Requested implants, devices or equipment are available ...E. Implant Verification: 1. Use of a separate implant verification process supports focused team communication and reduces surgical/procedural errors”. The hospital reviewed the policy on 5/07/2025, however no revisions were made. 3. On 6/12/2025, the clinical record of Pt. #2 was reviewed. Pt. #2 was scheduled for an elective surgical procedure: Cervical 5-6 Disc Replacement (surgery of the spine) on 8/12/2024. The clinical record including the following: - The Orthopedic Surgeon’s (MD #4) ‘Clinical Notes’ on 8/12/2024 at 7:30 AM included, “ ...Upon [MD #4] arriving at the operating room [Pt. #2] was undergoing anesthesia. That is when [MD #4] began [MD #4’s] preoperative checklist, going over instruments, the microscope, the setup of the room, as well as the implants that would be needed. It was at that point that [MD #4] realized that the implants were not available and the rep (vendor representative) was not present ...[MD #4] called the rep and it was impossible to get this type of cervical disc replacement instrument into the hospital within a reasonable amount of time ...it would have taken about 30 minutes to an hour to deliver [implant] to the hospital and likely another 3-4 hours of sterile processing. This is certainly not a safe amount of time to be under anesthesia waiting. The surgery had not started, and no incision had been made yet. Therefore [the surgical team] decided to reverse anesthesia and [MD #4] followed up with [Pt. #2] in the postoperative holding area to explain what happened. The rep should have been made aware of this surgical procedure. Secondly, [MD #4] believe that all instrumentation and implants should be acknowledged prior to the patient entering the room. Lastly, [MD #4] did go to the surgical coordinator/scheduler and ensured that we had ordered the proper implants and correctly filled out the order for the surgery and that was deemed to be done correctly.” 4. On 6/11/2025, the hospital’s ‘Patient Safety Event Form’ (8/12/2024) included, “ ...Pt. #2 ...Event type: Surgery/Procedure/Anesthesia ...Main OR ... Event summary: A spine case was cancelled this morning, there was no vendor rep that is going to support the case. [Pt. #2] was already intubated when the team and the surgeon found out there was no vendor support. [Pt. #2] was woken up, extubated and recovered in the PACU (Post-Anesthesia Care Unit) ...Reviewer summary: The vendor was not able to confirm. The rep that is listed in case check was transferred to another department. Team member coaching provided. Reported in safety huddle. Referred to Patient Relations. Risk Management for review ...Safety Event Classification: ...No harm ...”. 5. On 6/11/2025, the hospital’s internal analysis in regard to Pt. #2’s incident was reviewed. The analysis indicated that the opportunity for improvement was that the vendor was not present, an inadequate process, and that the team will review the case check process prior to procedures and determine if the Vendor is present prior to the timeout. The hospital provided two staff meeting attestations that included discussion of the hospital’s Time Out and Sign Out process on 2/04/2025 and discussion of vendors not moving supplies on 3/04/2025. The analysis did not include supporting documentation of case check review nor further review of hospital processes nor identified opportunities for improvement and indicated that the safety event was closed on 8/30/2024. 6. On 6/16/2025, the hospital’s surgical ‘Case Check’ for 8/12/2024 indicated that a vendor was requested for Pt. #2’s surgery on 8/07/2024, without response. The “Case Check” did not indicate that additional requests were made to the Vendor. 7. On 6/12/2025 at approximately 9:08 AM, an interview with the Anesthesiologist Resident (MD #5) was conducted. MD #5 stated that Pt. #2’s Anesthesiology team was given the ‘all clear’ (procedure set-up is complete and ready for patient) and Pt. #2 was brought to the OR and anesthesia was induced. MD #5 stated that the Surgeon (MD #4) realized that during the surgical team’s ‘Time Out’, the Vendor nor the surgical implant was not present. MD #5 stated that the surgery was canceled at that time, anesthesia was reversed, and Pt. #2 went to PACU for recovery. 8. On 6/12/2025 at approximately 9:23 AM, an interview with the Surgeon (MD #4) was conducted. MD # 4 stated that MD #4 entered the OR for surgical procedure and during the Time-Out process with the surgical staff, MD #4 realized that the Vendor rep was not present nor the cervical implant. MD #4 stated that the request for the Vendor was sent, and it appeared as the rep did not accept. MD #4 stated that the case should not have been scheduled. MD #4 stated that MD #4 was not made aware that the Vendor did not accept nor that the implant would not be available for the procedure. 9. On 6/12/2025 at approximately 9:48 AM, an interview with the OR Circulator (E #18) was conducted. E #18 stated that prior to a patient entering the OR, the room should be setup with all required equipment, including implants. E #18 stated that prior to surgery, the Charge Nurse tried to contact the rep, but the surgical team had not received information about the rep’s time of arrival. E #18 stated no recollection of a change in hospital practice/process in the OR since Pt. #2’s event, however the team double checks that all equipment and the Vendor rep, if required, is available prior to a patient entering the OR. 10. On 6/12/2025 at approximately 10:05 AM, an interview with the Surgical Technician (E #20) was conducted. E #20 stated that E #20 provided set-up for Pt. #2’s surgical case. E #20 stated that trays were set-up as identified on the preference card (list that indicates equipment/supplies needed for specific case). E #20 stated that the preference card includes the list of trays needed, but not implants. E #20 stated that the OR Circulator and the Surgeon communicate to determine readiness of a patient being transferred to the OR. E #20 stated that if a vendor rep is required for a case, the rep should be in the OR prior to the patient’s arrival. E #20 stated that the vendor rep did not arrive for Pt. #2’s case and the surgery was canceled. 11. On 6/12/2025 at approximately 12:28 PM, an interview with the Sterile Processing Department Manager (E #24) was conducted. E #24 stated that the Pt. #2’s vendor tray was not received prior to Pt. #2’s scheduled surgery date on 8/12/2024. 12. On 6/16/2025 at approximately 10:13 AM, an interview with Assistant Clinical Manager (E #16) and the Director of Surgical Services (E #17) was conducted. E #16 stated that there are no supporting documents of the education that was provided to staff in regard to vendor verification of equipment. E #17 stated that the hospital’s Universal Protocol policy is followed for pre-procedural verification and that there is currently a new tracking system for vendor trays. E #16 and E #17 had no additional documentation to provide in regard to the hospital’s follow-up to Pt. #2’s safety event.”

“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: 34411 Based on document review and interview, it was determined that for 2 of 2 (Pt #1, Pt #11), clinical records reviewed for falls in the outpatient setting, the hospital failed to ensure that a nursing assessment; post fall documentation; or actions plans were implemented following fall events. Findings include: 1. The hospital’s policy titled, “Adult Patient Falls-Prevention and Intervention” (dated 10/23/2024) was reviewed and required, “ ...Fall-Related Injury Level: The fall-related injury level is assessed at the time of the fall when the extent of the injury may not yet be known ...Minor[injury]: Resulted in ...pain, bruise, or abrasion, subgalea hematoma [localized blood clot due to trauma] ...Physiological Falls: A fall attributable to one or more intrinsic, physiological not urgent factors. Physiological falls include: Falls caused by a sudden physiological event such hypotension ...Unobserved fall: Include any case when a staff member finds the patient on the floor or other surface or when a fall is reported by the patient, a family member, or visitor ...Teammates will complete a patient safety event report after each patient fall event or near miss. Teammates will complete an injury report if indicated.” -Attachment D: MW Region Adult Outpatient/HOD & Emergency Department Procedure: Attachment to the Midwest Region Adult Patient Falls-Prevention and Intervention (dated 10/18/24), was reviewed required, “ ... Teammates will monitor and support safety to prevent accidental and unpredictable falling by: Implementing environmental safety precautions ...Instruct patient about the extent to which they can get up with/without assistance. Provide patients with call light or mechanism ...Monitoring patients for changes in physiologic status that may increase risk for unpredicted falling ...Post-Fall Assessment/Care: Implement appropriate emergency response based on setting until relieved by responding teammates or emergency personnel. Monitor and document post fall assessment per patient presentation/condition.” 2. The clinical record for Pt #1 was reviewed on 3/12/2025. Pt #1 presented to the hospital’s Outpatient Pain Clinic on 7/1/2024 for an epidural steroid pain injection. Pt #1 was transferred to the hospital’s ED (emergency department) following the procedure, for evaluation. Pt #1 discharged home from the ED on 7/1/2024. Pt #1 arrived at the Medical Office Center (Outpatient Pain Clinic) on 7/1/2024 at 8:06 AM for an epidural steroid injection. - The Interventional Procedure note (dated 7/1/2024), documented by the Anesthesiologist (MD #1), included, “Procedure: Therapeutic & Diagnostic Injection, Lumbar [back] epidural steroid injection ...Sign out: Final Procedure performed as above. Complications: Once loss was achieved and contrast confirmed location the patient endorsed feeling nauseous. HR (heart rate) was low 50’s [normal range 60-100], down from [Pt #1] 70’s. The steroid was injected and the patient was flipped on [Pt #1’s] back and [Pt #1’s] legs were raised. The patient’s BP (blood pressure) remained stable and reported improvement. The patient was then monitored on [Pt #1’s] back 15 minutes with normal HR and BP. Patient endorsed that [Pt #1] had resolution of [Pt #1’s] symptoms. Patient sat up at the edge of the bed without difficulty. [Pt #1] was provided water. Soon after the patient had second episode of feeling nauseous and fell to the ground. [Pt #1’s] right frontal region did impact the floor. The patient was assessed and was neuro (neurologically) intact ...The ER (emergency room) was notified and both me [MD #1] and the Registered Nurse [RN/E #2] transported to the ER ...Report was given to the triage nurse and the patient was transferred to the ER care time ...” - Pt #1’s nursing documentation from the Outpatient Pain Clinic RN (E #2), dated 7/1/2024, was reviewed. The clinical record included 2 sets of Pt #1’s vital signs on the flowsheet (at 8:35 AM and 8:58 AM), from the registered nurse. The clinical record lacked any further nursing documentation or assessments, including a post-fall assessment or a post-fall huddle form. - Pt #1 arrived at the ED on 7/1/2024 at 9:54 AM. - The ED triage note (dated 7/1/2024 at 10:03 AM), included, “Chief complaint. Syncope (Syncopal) post procedure [fainting], hit [Pt #1] head, brought in from pain control clinic, receiving fluids prior to arrival, hit right side of head post procedure ...” - The ED Provider note (dated 7/1/2024 at 11:01 AM), included, “presents [to] ED today for evaluation after 2 syncopal episodes at the pain clinic with fall after second episode... At this time, will plan for CT [computerized tomography/imaging] head given hematoma [blood clot under skin due to trauma] to right head as well as fall to the ground with [Pt #1] head being strike ...Will assess patient for potential underlying causes of [Pt #1] syncope ...Patient presentation may also be secondary due to vasovagal syncope due to [Pt #1’s] first day of pain clinic injections. Will anticipate likely discharge home pending reassuring ED workup ...” - The ED Provider note, (dated 7/1/2024) indicated that Pt #1 was discharged home on 7/1/2024 at 12:42 PM. - Pt #1 sustained an injury on 7/1/2024, due to a fall. Pt #1’s clinical record lacked a nursing post-fall risk assessment, completion of the post fall-huddle form or any interventions or actions plans implemented to prevent future falls. 3. A Patient Safety Event Form for Pt #1 (dated 7/1/2024 at 2:41 PM), was reviewed. The event summary included a detailed account of Pt #1’s fall event on 7/1/2024. The event summary included follow-up documentation regarding Pt #1’s grievance about billing. However, the event summary lacked any investigation, follow-up actions or discussion related to the fall on 7/1/2024. The hospital was unable to provide any investigation or education regarding Pt #1’s fall, to date (3/13/2025). 4. The clinical record for Pt #11 was reviewed on 3/13/2025. Pt #11 presented to the Outpatient Pain Clinic on 10/29/2024 for a pain management procedure. - Pt #11 had a fall event on 10/29/2024. Pt #11 had an assisted fall to the floor. Pt #11 discharged home from the Outpatient Clinic on 10/29/2024. There were no documented injuries. Pt #11’s clinical record lacked a nursing post-fall risk assessment, completion of the post fall-huddle form or any interventions or actions plans implemented to prevent future falls. 5. On 3/12/2025 at 2:08 PM, a phone interview was conducted with the Outpatient Pain Clinic RN (E #2). E #2 stated that Pt #1 came in for a pain procedure. E #2 stated that Pt #1 fainted after the procedure and was laid back on the table. E #2 stated that after Pt #1 recovered, Pt #1 sat up on the table for 5 minutes. E #2 stated that while Pt #1 was sitting on the table, another patient came in. E #2 stated that E #2 left Pt #1’s room. E #2 stated that when E #2 was out of Pt #1’s room, E #2 heard a loud thump. E #2 stated that E #2 went back into Pt #1’s room and saw that the patient was on the floor. E #2 stated that Pt #1 was assisted into a wheelchair and was then transported over to the ED. E #2 stated that the only discussion following, Pt #1’s fall, was with E #5 (Unit Manager), in which E #2 complained about the need of another nurse. E #2 stated that E #2 also voiced the concern of needing call lights in the patient rooms. E #2 stated that since July 2024 to current, there have not been any call lights installed in the patient rooms. E #2 stated that there has not been any education or in services post Pt #1’s fall event. E #2 reviewed Pt #1’s clinical record and confirmed that a nursing note/assessment was not documented following Pt #1’s fall. 6. On 3/13/2025 at 10:18 AM, an interview was conducted with the Chief Nursing Officer (E #1). E #1 stated that E #1 provides oversight to both inpatient and outpatient nursing areas. E #1 stated that in regard to outpatient clinical areas, fall prevention would include assessment of the patient’s diagnosis and history. E #1 stated that if a patient had a history of falls or syncope, then extra precaution will be taken with assisting patients entering and exiting the exam room. E#1 stated that if a patient had a syncope event, additional monitoring should take place. E #1 stated that if a patient falls, the first step would be to assess the patient for injuries. E #1 stated that the expectation from the nurses following a fall, would include the nurse documenting an assessment and if there was harm/injury to the patient. E #1 stated that a safety event/incident form should be documented and there should be follow-up and an action plan implemented on that safety event form. E #1 acknowledged that Pt #1’s safety event form (7/1/2024), lacked follow-up investigation related to the fall.”