Wakemed, Raleigh Campus

“CONTRACTED SERVICES CFR(s): 482.12(e)(1) The governing body must ensure that the services performed under a contract are provided in a safe and effective manner. This Standard is not met as evidenced by: 50318 Based on contract review, contract renewal information, quality data review, closed medical record review, and staff interviews, the hospital’s governing body failed to ensure services provided by a contractual agency were provided in a safe and effective manner for 1 of 1 contract services reviewed. The findings include: Review of the contract on 11/21/2025 revealed on 06/01/2019, the hospital entered into an agreement/contract with (Company A). Review of contract renewal information on 11/21/2025 revealed Exec Dir #16 was made aware via email on 03/13/2025 that the (Company A) contract needed to be renewed before 06/11/2025. The terms were reviewed and confirmed to be on yearly auto-renewal as of 05/31/2023 unless a decision was made to terminate. Exec Dir #16 and the legal team confirmed the renewal of the contract with (Company A) on 03/14/2025. Review of quality data from quarter one to available data from quarter four of 2025, (Company A) was evaluated for completed and failed (the driver cancelled) rides. Review of data from September 29 to October 27, 2025 revealed the completed ride percentage per week ranged from 71% to 75%, with an average of 74% for completed rides. Closed medical record review on 11/19/2025 for Patient #1 revealed a 54-year-old patient who presented to the Emergency Department (ED) on 03/10/2025 at 0116 via EMS (Emergency Medical Services) for hearing voices, had suicidal ideations (cause harm or death to one self), and the patient wanted his Invega (long-acting injectable anti-psychotic medication) injection. The plan was for medical clearance and a behavioral health (BH) evaluation. A Behavioral Health Assessment was performed at 0249 by a LCSWA (Licensed Clinical Social Worker Associate). The patient’s disposition was deemed appropriate for behavioral health outpatient level of care with a plan to contact his legal guardian. ED Provider Note update at 0319 revealed the patient was assessed by psychiatry and was felt to be appropriate for discharge. SW Note dated 03/11/2025 at 1304 revealed the patient agreed to return to the group home and work with his guardian on finding another placement. The patient’s disposition was set to discharge at 1327 with a delayed discharge selected at 1332 as transportation delay. BH Clinician Note at 1612 revealed discharge ride was arranged with (Company A) with an ETA (estimated time of arrival) of 1617. BH Clinician Note at 1634 revealed a second ride was arranged as the previous ride did not show up. BH Clinician Note at 1646 revealed a third ride was requested as the “driver could not find the pt (patient).” BH clinician called (Company A) for support, who instructed the clinician to retry a new ride. Additional BH Clinician Note at 1646 revealed a fourth ride was arranged with an ETA of 1733. Additional BH Clinician Note at 1646 revealed the driver arrived, and the clinician called the staff to inform them. The staff reported the patient had walked off. Interview on 11/19/2025 at 1342 with Director #1 and Nurse Manager #2 revealed Patient #1’s legal guardian was not able to pick up the patient, neither was the group home, and (Company A) was utilized instead. Director #1 revealed the area near patient registration was a common area used for patients to wait for (Company A) drivers, and it was close to the locked unit Patient #1 had been on. Interview revealed (Company A) drivers could switch based on how close a driver was to the location, and there was a certain time limit (approximately 5 minutes) a driver would wait for a patient, and then the driver would leave. Director #1 revealed the patient waited outside with MHT #3, who called CM #5 for updates on the drivers. MHT #3 tried to wave one of the drivers down, but they did not stop. The patient and MHT #3 waited outside for approximately an hour. Follow-up interview on 11/20/2025 at 1043 with Director #1, Director #7, and Nursing Leader #8 revealed (Company A) would provide reports, including the number of rides requested, number of rides canceled, and number of rides failed. The leadership team would review and evaluate the reports, including the failed requests for opportunities and follow-up. The leadership team planned to provide monthly reports to the Accreditation Readiness Oversight Committee. Interview revealed Nurse Manager #2 emailed (Company A) Senior Manager on 03/14/2025 to discuss issues with the timeliness of rides leading to negative outcome for Patient #1 and to request a meeting to discuss solutions with timeliness and communication. Interview revealed Nursing leadership and (Company A) leaders met on 03/20/2025. Interview on 11/21/2025 at 1640 with Exec Dir #16 revealed (Company A) contract agreement was auto-renewed yearly, which started in 2023. Exec Dir #16, along with the facility’s legal team, would review the contract yearly, typically in February or March, to verify the terms and review if anything needed to be changed. Interview revealed there was a quarterly quality review, focusing on the cybersecurity of the platform that was used to secure rides. Exec Dir #16 revealed there were quality metrics for the ride share company to maintain, including a minimum of 75% for completed rides. (Company A) was aware that they were being monitored as they provided a dashboard to the facility with monthly, quarterly and year-to-date data, but the quality metrics were not specified in their contract. Exec Dir #16 revealed monthly invoices were sent out to each department, along with the quality data by department for (Company A), and the Managers were expected to review the summary for their unit each month. Interview revealed if (Company A) was not meeting expectations, an action plan would be developed but that had not happened. Exec Dir #16 revealed (Company A) had not been under 75% for completed rides as far as the Exec Dir was aware.”

“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: 50403 Based on a review of policies, the medical record reviews, internal document reviews, quality improvement data reviews, and staff interviews, hospital staff failed to monitor actions taken after an adverse event, for 1 of 1 sampled patients with an adverse event (Patient #2) The findings include: Review of hospital policy,”Telemetry Surveillance Center-Nursing,” effective 11/20/2024, revealed, “Purpose: To establish responsibilities for the monitor tech and nursing to maintain a consistent standard for patients monitored by the Telemetry Surveillance Center (TSC) by providing constant surveillance from a central location... Procedures: b. Nursing communication/Management of Telemetry Monitored Patient: i. Order or level of care obtained for telemetry monitoring... ii. Notify TSC.. iii. Data should include: 1. Patient name and room number 2. Any significant rhythm history 3. Admission diagnosis and level of care...iv. The nurse will verify and document proper telemetry transmission and telemetry box number, upon admission...” Review of hospital policy, “... Quality Assurance and Performance Improvement Plan 2025”, revealed, “...Prioritization of Improvement Needs and Proactive Risk Assessments:...When new processes are being designed or existing ones are being redesigned, the following elements are considered...Testing and analysis to determine whether the proposed design or redesign is an improvement...” Observation of telemetry monitoring on 11/19/2025 at 1543 revealed two monitor techs sitting at the station, each monitoring a set number of patients. MT #14 had 23 patients being monitored with 8 of these had a ‘leads fail message’ or ‘no leads message’ indicated on the monitor screen. MT #14 had no documentation of why these monitors revealed this message in the Patient log. MT #15 had 3 monitors with ‘no leads on’ and observation revealed documentation of the messages related to patients were on a sticky notes. Closed medical review on 11/19/2025 of Patient #2 (Pt#2) revealed a 56-year-old male who presented to the Emergency Department (ED) on 11/23/2025 at 0623 with shortness of breath. At 0624 Pt #2 was placed in a room in the ED and provider was notified. Vital signs at 0631 on arrival revealed a Pulse ox ( noninvasive way to measure oxygen in the blood) 78% on RA (room air). At 0632 Oxygen was placed on 6 liters per minute on NC (Nasal Cannula) with pulse ox result of 89% then oxygen was increased to 15 Liters NRB (Nonrebreather Mask) with pulse ox 100%. Triage was started at 0634 and an ESI (Emergency Severity Index) level 2 (high risk) was assigned. 0641 Provider evaluated the patient. At 0643 orders were placed for the following: Respiratory-continuous pulse ox and heart monitoring. 0656 RT at bedside to place patient on high flow NC. At 0704 EKG was done with NSR (Normal sinus rhythm) resulted. Nursing note revealed at 0737 that “patient was resting comfortably in stretcher at this time in no apparent distress, High flow O2 set up at bedside by RT and on patient.” Nursing note did not reveal if patient was on a cardiac monitor. At 0755 Nursing note revealed “...found patient unresponsive and pulseless, monitor leads were off and CPR (Cardiopulmonary resuscitation) was initiated. ED Provider was called to the bedside.” Medical record review revealed multiple attempts of CPR and then admission to ICU (Intensive Care Unit). Further review of medical record revealed patient expired 1/31/2025 at 1412. Medical record review did not reveal evidence of when cardiac monitoring was applied or if a call was placed to the telemetry monitoring techs for admission to the TSC after the initial order at 0643. Medical record review did not reveal evidence of heart monitoring orders completed. Review of a timeline of investigation and actions for this event on 11/20/2025 revealed “...Incident report was completed on 01/21/2025...On 1/29/2025 file was reviewed at Serious Event Review Committee-referred to Nursing Services Quality Committee. On 02/27/2025 this was discussed at the Cardiac Monitoring Committee meeting and the following actions were taken: 1. Initiate support to the ED nurses with monitoring: TSC tech will watch for cardiac monitoring orders and admit patient to monitor and pull initial rhythm strips....On 03/07/2025 TSC meeting occurred to determine how TSC techs could support ED nurses with watching for cardiac monitoring orders and automatically admitting patients to the monitor. On 03/11/2025 TSC leader and ED leadership met to operationalize TSC tech watching for cardiac monitoring orders and admit patient to monitor... Huddles started after staff meeting to roll out the new process but no documentation of this occurring was available...” No evidence of collection of data monitoring was available to reflect the process change or any new policy reflecting the TSC tech responsibility in the new process. Request on 11/20/2025 for data on the monitoring of the telemetry processes revealed that no data existed. Changes were made verbally. Request for a new telemetry policy revealed no new policy existed. Telephone interview on 11/19/2025 at 1300 with RN #10 revealed that she remembered Pt #2. Interview revealed that Pt #2 was found unresponsive, pulseless, and not sure if heart leads were on or not. RN #10 interview that after CPR episode no further education or debriefing about the situation occurred. Interview revealed RN #10 had no recall of any changes being made. Telephone interview on 11/19/2025 at 1400 with RN #9 revealed RN #9 recalled the patient. Interview revealed that “I did an incident report” but no debriefing on the situation occurred afterwards nor was there any recall of education regarding any changes being made. Interview on 11/19/2025 at 1510 with NM #13 revealed that measures were taken to revise the telemetry process but no data was collected and reviewed to determine the efficiency of the new process. Interview on 11/19/2025 at 1515 with Director #12 revealed that telemetry techs monitor the patient and document in the patient log the events of the patient during their stay. Interview revealed monitor techs are to document in ‘real time’ as things happen for the patients. Director #12 interview revealed that Director #12 did not have any quality data of the monitoring regarding telemetry patients. Interview with MT #15 revealed that “we are supposed to document in the patient log as things happen but I document at the end of the shift”. Patient log revealed no documentation since 12 hours ago. NC00233685; NC00220734; NC00228308”

“COMPLIANCE WITH 489.24 CFR(s): 489.20(l) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to comply with §489.24. This Standard is not met as evidenced by: 33790 Based on policy review, medical record review, and staff and physician interviews, the hospital failed to comply with 42 CFR §489.20 and §489.24. Findings included: The hospital failed to ensure a thorough medical screening examination was provided that was within the capability of the hospital’s Dedicated Emergency Department (DED) to determine whether or not an emergency medical condition existed for 1 of 27 sampled DED patients (Patient #4). Cross Refer to A2406.”

“MEDICAL SCREENING EXAM CFR(s): 489.24(a) & 489.24(c) (a) Applicability of provisions of this section. (1) In the case of a hospital that has an emergency department, if an individual (whether or not eligible for Medicare benefits and regardless of ability to pay) “comes to the emergency department”, as defined in paragraph (b) of this section, the hospital must- (i) Provide an appropriate medical screening examination within the capability of the hospital’s emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition exists. The examination must be conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations and who meets the requirements of §482.55 of this chapter concerning emergency services personnel and direction; and (ii) If an emergency medical condition is determined to exist, provide any necessary stabilizing treatment, as defined in paragraph (d) of this section, or an appropriate transfer as defined in paragraph (e) of this section. If the hospital admits the individual as an inpatient for further treatment, the hospital’s obligation under this section ends, as specified in paragraph (d)(2) of this section. (2)(i) When a waiver has been issued in accordance with section 1135 of the Act that includes a waiver under section 1135(b)(3) of the Act, sanctions under this section for an inappropriate transfer or for the direction or relocation of an individual to receive medical screening at an alternate location do not apply to a hospital with a dedicated emergency department if the following conditions are met: (A) The transfer is necessitated by the circumstances of the declared emergency in the emergency area during the emergency period. (B) The direction or relocation of an individual to receive medical screening at an alternate location is pursuant to an appropriate State emergency preparedness plan or, in the case of a public health emergency that involves a pandemic infectious disease, pursuant to a State pandemic preparedness plan. (C) The hospital does not discriminate on the basis of an individual’s source of payment or ability to pay. (D) The hospital is located in an emergency area during an emergency period, as those terms are defined in section 1135(g)(1) of the Act. (E) There has been a determination that a waiver of sanctions is necessary. (ii) A waiver of these sanctions is limited to a 72-hour period beginning upon the implementation of a hospital disaster protocol, except that, if a public health emergency involves a pandemic infectious disease (such as pandemic influenza), the waiver will continue in effect until the termination of the applicable declaration of a public health emergency, as provided under section 1135(e)(1)(B) of the Act. (c) Use of dedicated emergency department for nonemergency services. If an individual comes to a hospital’s dedicated emergency department and a request is made on his or her behalf for examination or treatment for a medical condition, but the nature of the request makes it clear that the medical condition is not of an emergency nature, the hospital is required only to perform such screening as would be appropriate for any individual presenting in that manner, to determine that the individual does not have an emergency medical condition. This Standard is not met as evidenced by: 33790 Based on medical record reviews and staff and provider interviews, the hospital failed to ensure a thorough medical screening exam (MSE) was provided that was within the capability of the hospital’s Dedicated Emergency Department (DED) to determine whether or not an emergency medical condition (EMC) existed for 1 of 27 sampled DED patients (Patient #4). The findings included: DED record review revealed Patient #4 (named patient) arrived to Campus B’s DED from home via EMS (emergency medical services)on 08/16/2025 at 1751 with a complaint of fall. At 1756 the chief complaint was updated to “Fall (Mechanical fall, right knee injury).” Patient #4 was assigned an ESI [acuity] of 3. Review of the Emergency Department Provider Note, date of service 08/16/2025 at 1751, revealed “...History... [Patient #4] is a 78 year old female who presents with knee pain after a fall. She experienced knee pain following a fall from a standing position. There was no injury to her head, neck, back, chest, or abdomen. She reports no shortness of breath or difficulty breathing. No numbness or weakness is present. She reports difficulty standing and straightening her knee due to pain. ...Physical Exam ....MUSCULOSKELETAL: Diffuse knee tenderness to palpation without malalignment. Soft tissue swelling in knee....CONSTITUTIONAL: Well-appearing....Alert and oriented and responds appropriately to questions....EXT (extremities): No long bone deformities.... NEURO: Alert, oriented, Moves all extremities. ... “ At 1810, Timeline review revealed “...ED Complex Assessment .... Gait Assessment: Not tested/Pt. cond. [patient condition]... Musculoskeletal Location: RLE [right lower extremity]. ... “ A “Complex Assessment,” also at 1810 noted “...Musculoskeletal... Exceptions to WDL (within defined limits)....R Knee: Limited movement....fall. ...” At 2020, an order was placed for CT (Computed Tomography- type of imaging) of the right lower extremity without contrast. The exam started at 2105. The ED Provider Note stated “...2309 No fracture, no deformity, no significant injury will ensure that patient is able to bear weight and discharge to home .... The patient is able to walk we will plan on discharge home... .” Timeline review revealed the ED Disposition was snt to “Discharge” on 08/17/2025 at 0003 and was noted as “Delayed Discharge....Reason for delay: When awake/Able to ambulate.” A Clinical Note, Discharge Instructions on 08/17/2025 at 0017 documented “Your x-rays and CT were negative for fracture and injury to the bone. However injuries to the soft tissue including ligaments and cartilage can lead to significant pain. Please follow-up with orthopedic surgery for further evaluation of your knee pain. ...” Review of the right knee x-ray result revealed “....IMPRESSION: Mild tricompartmental degenerative changes. No acute fracture or dislocation. ...” The CT Extremity Lower Right Without IV Contrast, final result 08/16/2247 revealed “ ...IMPRESSION: No acute fracture. Tricompartment degenerative changes of the right knee joint. ...” Patient #4 was discharged with family at 0115. The Timeline Departure Condition was noted as “Good” and mobility at departure was described as “Ambulatory.” Record review of imaging failed to reveal any x-rays of the hip or upper leg and did not reveal a pain score at the time of discharge. There was no note found to indicate how much Patient #4 walked, only that there was a return demonstration on crutch use and the word ambulatory for mobility. Telephone interview with Registered Nurse (RN) #10, on 11/21/2025 at 0950, revealed the RN recalled Patient #4. Interview revealed the patient was in a hallway bed and had a knee injury. Interview revealed RN #10 was the Triage Nurse. Interview revealed RN #10 would look at the patient’s injury as much as possible, but if in the hallway would not have removed clothes to look at the hip for privacy. Interview revealed the RN would get the patient positioned on the stretcher so the physician could evaluate the patient. Telephone interview with RN #11, on 11/21/2025 at 1020, revealed RN #11 did not recall Patient #4. Interview revealed they generally did a focused assessment, if there was a deformity in the limb the RN would document. Interview revealed in a hallway bed, RN #11 may not uncover the patient to do the full assessment but would find out where the patient fell (on the body) and would ask about landing on a hip. Further, RN #11 stated she would ask about pain, “where else does it hurt”, and may have the patient ambulate. Interview revealed most patients were pretty sure about where they landed and could describe the fall. Interview revealed they generally did not do full body imaging. Telephone interview with Medical Doctor (MD) #12, on 11/21/2025 at 1101, revealed the MD recalled seeing Patient #4 in the ED. MD #12 stated in evaluating after a fall they determined what caused the fall, was it they just fell or did they pass out and fall, and they evaluated the whole body. Interview revealed MD #12 evaluated the full limb - for a leg... hip to toes. Interview revealed MD #12’s standard practice was to gently try to rotate the hip and if no pain, continue rotating and evaluating the full limb. Once the pain was localized, such as in the knee, then the focus was on the knee and evaluating the knee fully. Interview revealed MD #12 did not recall if she observed the patient walk or not. MD #12 stated the standard work was to collaborate closely with nursing- can the patient walk/ move and if not, the patient would be re-evaluated. Generally, there were face-to-face discussions with nursing. The discharge orders, interview revealed, were “if can ambulate.” Interview revealed MD #12 would expect a nurse would come back and say “no, they can’t do it” if that was the case MD #12 stated if they were not moving towards a safe discharge the nurses would come and discuss the concerns; the standard practice was if a patient was in too much pain or unstable, they would stay overnight. Interview revealed that with the order written when discharging the patient, the MD thought the patient could walk/bear weight. If not, then they would have proceeded differently. If the patient was not solid on crutches, the MD would generally hear that from nursing and move to a walker. MD #12 indicated all of the focus seemed to be on the knee pain but her standard evaluation for fall would have included the hip. Interview further revealed a change in charting had occurred recently which “probably did not help” in documenting the evaluation done. MD #12 stated the documentation should show the standard exam that was done and the documentation in the record did not show it. Medical Record review from Hospital C revealed Patient #4 arrived to the Hospital C ED on 08/20/2025. Review of the Triage Note at 1204 revealed “BIB [brought in by] EMS from home due to right hip pain. Pt fell Saturday while cleaning. Pt states worsening since Saturday and unable to stand on leg today. Pt brought CT and Xray from (Hospital A name) disc. Review of the ED Provider Note at 1157 revealed “...HPI ....presents for hip pain after a fall. The patient states she was cleaning her shower when she had a fall a couple of days ago and now is having right hip pain. She states going to (Ortho Clinic Name) for this today who noted she had a femoral neck fracture and was sent here....PHYSICAL EXAM....Tenderness to the right hip. Bruising to the right knee. No joint tenderness, deformity, no muscular tenderness noted...ED COURSE & MEDICAL DECISION MAKING .... Patient presents today for right hip pain after a mechanical fall a few days ago....I have spoken to anesthesia we will perform a nerve block for pain control. Given confirmed femoral neck fracture, patient requires admission for orthopedic evaluation and surgical management. She remains stable at this time. ...” Review of the Operative Report revealed a pre-operative diagnosis of “Closed displaced fracture of right femoral neck.” Patient #4 underwent a right total hip arthroplasty on 08/21/2025. The medical screening exam at WakeMed did not document examination of Patient #4’s hip, ankle, and vascular status of her right lower leg.”