Prisma Health Greenville Memorial Hospital

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 28883 Based on record reviews, interviews, and policy review, the hospital failed to protect patient rights by not ensuring a safe environment of care for 2 of 2 patients reviewed who sustained injuries while in the Neonatal Intensive Care Unit, Patients #1 and #2. The findings included: Cross refer to A-145/ 482.13(C)(3), Patient Rights, Free From Abuse or Harassment: The hospital failed to ensure thorough investigations were conducted of allegations of possible staff involvement in fractures for Patients #1 and #2.”

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 28883 Based on record reviews, review of the hospital’s Quality Assessment Performance Improvement (QAPI) Program, and interviews, the hospital’s Quality program staff failed to ensure that adverse events/injuries of unknown origin that occurred under the hospital’s care were assessed for possible staff involvement and/or abuse after allegations of the same had been made by family for 2 of 2 patients (pts) receiving care in the Neonatal Intensive Care Unit, Pts #1 and #2. The findings included: Cross Refer to A-286/ 482.21(a), (c)(2), (e)(3) Patient Safety: The hospital’s governing body failed to ensure that clear expectations for safety had been established related to the reporting and thorough investigation of allegations of staff involvement in fractures for Patients #1 and #2. The hospital’s Administrative/Quality staff failed to perform a thorough investigation and analysis of the cause of the fractures for Patients #1 and #2.”

“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: 28883 Based on record reviews, interviews, and policy reviews, the hospital failed to ensure thorough investigations were conducted of allegations of possible staff involvement in fractures for Patients #1 and #2, 2 of 2 patients (pts) in the Neonatal Intensive Care Unit that sustained fractures. The parents of Pts #1 and #2 expressed concerns of staff involvement in the fractures to hospital staff. This information was not placed into the hospital’s event reporting system so it could be investigated as an incident of possible staff abuse/involvement. The hospital failed to ensure a thorough investigation into the allegations of staff involvement in the injuries as all staff that may have had knowledge of how the fracture may have occurred (staff that may have seen or heard something) were not interviewed. The analysis of possible causes of the fracture did not include a review of possible staff abuse. The findings included: Patient #1 Record review on 1/6/25 revealed the hospital admitted Pt #1 on 8/10/25 at 1 day of age after being transferred to the hospital for a higher level of care. Pt #1 was found to have limited range of motion in the right arm on 8/17/25 and an X-ray confirmed a right humerus fracture. The fracture had been placed into the hospital’s safety event reporting system, to be reviewed for standard of care/applicable treatment/procedure/surgery etc, deviation, and patient outcome level of harm. Review of the Safety event report revealed care by medical/nursing staff had been reviewed through medical record review and by interviews of nurses that had provided direct care of the patient. There were no deviations noted from the standard of care. Medical causes for the fracture had been ruled out. Review of a Case Management note by Social Worker #1 dated 8/18/25 at 4:15 PM revealed information that the Social Worker had went to the bedside and spoke with the mother and father of Pt #1 to let them know the Department of Social Services and Law Enforcement referrals had been made, why they were made, and the next steps that would take place (due to the fracture of unknown origin). The Social Worker documented, “...Parents concerned about pt’s injury and that s/he could have been hurt by staff...”. A phone interview was conducted on 1/7/26 at approximately 1:30 PM with Social Worker #1. The Social Worker (SW) was asked about the addendum s/he had documented on 8/18/26 at 4:15 PM. SW #1 verified that the parents had expressed concern about possible staff involvement in Pt #1’s fracture. When asked if s/he had reported this allegation of possible staff abuse/involvement in the fracture to Pt #1 to anyone or had put in in the hospital’s event reporting system as an allegation by the parents, SW #1 stated s/he hadn’t reported this. During an interview on 1/7/26 at 1:40 PM, the Pediatric DON stated that s/he had been aware of the parents allegation of possible staff involvement. The DON stated that s/he had conversations about Pt #1 with SW #1; and sometime during one of the conversations the allegation had been mentioned. According to the DON, his/her first priority was to speak with the nurses but s/he did not think that there was staff involvement in the injury for Pt #1. Review of Grievances revealed the mother of Pt #1 called into advocacy for the hospital on 8/20/25 to officially report that between 8/14/25 and 8/17/25, Pt #1’s right arm was fractured without explanation while in the NICU receiving care. The Nurse Manager for the NICU was an assigned reviewer and noted that a safety event had already been placed and investigation is ongoing. A letter mailed by Advocacy from the hospital to the mother of Pt #1 on 9/19/25 stated that an investigation was completed and sent to the attention of Clinical Leadership, including the Vice Chair of Gynecology, the Chair of Orthopedics, and the Director of Nursing; and the hospital was unable to determine the origin of (Pt #1’s) fracture. The hospital’s event report for the fracture for Pt #1 had been closed out on 9/23/25 without evidence the hospital had done a thorough investigation into possible staff abuse or involvement in the humerus fracture of Pt #1. According to the Safety event report, the Nurse Manager of the NICU documented that (through interview) nurses have disclosed they had very few concerns with parents and they reported no knowledge of injury during hands on care. There were no interviews included of other staff (nurses working with other patients, the unit secretary, or Providers) that may have seen or heard something that could give insight into possible staff abuse/involvement in the injury. During an interview on 1/5/26 at 3:03 PM, the Pediatric Director of Nursing (DON) who had been the Nurse Manager of the NICU in August of 2025 stated s/he had taken statements on 8/18/25 from the nurses working with Pt #1 during the timeframe the fracture occurred. Review of the statements taken by the Pediatric DON revealed s/he had spoken to Registered Nurses (RNs) #1, #2, #3, #4, #5, #7, and #8. There was no statement obtained from RN #6 who had taken care of Pt #1 for a brief period on 8/17/25 in the early morning hours. Review of the statements documented by the Pediatric DON revealed the nurses had provided information related to the care provided to Pt #1 and how the infant was during the time period of the care; and the activity/involvement of the parents in the infants care. There was nothing mentioned about whether the nurses knew or if they had seen or heard something that may help to determine whether staff may have been involved in the injury. The Pediatric DON was asked about the interview notes and stated that s/he told the nurse(s) what was going on, that Pt #1 had a humerus fracture. When questioned as to whether anyone had asked the nurses if they knew (seen or heard anything) as to what happened to cause the fracture for Pt #1, the Pediatric DON stated that s/he had not asked this as this was the purview of forensics. An interview was conducted on 1/6/26 at 12:55 PM with the Pediatric DON/former Nurse Manager of the NICU. According to the Pediatric DON, s/he had not interviewed all staff that would have worked in the NICU during the timeframe of the fracture of unknown origin for Pt #1, just the nurses that had worked directly with Pt #1. When asked if anyone else could have provided care besides the direct care nurses assigned to Pt #1, the DON stated that since they are constantly addressing the needs of all babies, nurses float and address needs as they arise. The DON verified that another staff member could have provided care but there was no documentation of every “touchpoint” (times when someone may have handled Pt #1). An interview was conducted on 1/6/26 at 11:00 AM with Officer #20 with the Greenville Health Authority (law enforcement responsible for the hospital). According to Office #20, s/he had coordinated with hospital staff to set up interviews for the nursing staff taking care of Pt #1 as well as the parents of the infant due to the fracture of unknown origin. The Officer stated s/he did ask the nurses/parents of Pt #1 if they knew how the fracture might have happened, and they all did not know. The Officer stated s/he had only interviewed the nursing staff providing direct care during the timeframe the injury occurred. Review of the police report included a summary of the interviews. An interview was conducted on 1/7/26 at 10:12 AM with Forensics Physician #1 who was board certified in abuse with a medical component. S/he stated taht they are consulted to see whether an injury could have been caused by abuse, accident, or if there was a medical cause related to a disease process. In the case of Pt #1 s/he had spoken to one of the nurses to understand the general care of the patient and supervision provided. Physician #1 stated it is not their job to be law enforcement and say who did it. They had looked for any medical reason for the patient to have easily broken the bone. They concluded this had been an inflicted injury. They do no know or decide on motivation (for the injury). We leave that to the investigators. During a phone interview on 1/7/26 at 11:39 AM, Patient Safety Partner #10 who had led the Root Cause Analysis (RCA)/investigation into possible causes of the fracture of unknown origin for Pt #1 was asked about whether staff involvement in the fracture had been considered. The safety coordinator stated it hadn’t since their record reviews and interviews showed there were no concerns with the care provided by the hospital staff and no indication that something had happened during the care by the staff. A phone interview was conducted with Patient Safety Coordinator #10 on 1/7/26 at 1:14 PM. S/he was asked if the police report of interviews with staff had been available to the team and discussed during the RCA meetings. According to the Safety Coordinator, the police report findings had not been available or reviewed during the RCA meetings. This was also verified during an interview on 1/8/26 at 9:35 AM with Risk Manager #11 who confirmed the police report / information obtained by police from the staff interviews had not been incorporated into the hospital’s analysis of possible causes of the fracture. Patient #2 The hospital admitted Pt #2 on 10/2/23, on the day of birth with Prematurity and Respiratory Immaturity. Review of the hospital’s event report for Pt #2 revealed that on 11/23/23, Pt #2 was noted with swelling of the right leg. An X-ray was ordered and right femur fracture noted. The NICU Nurse Manager had documented that a review of the electronic medical record had been done, and appropriate actions taken “...(provider notification, documentation, skeletal series, etc) once symptoms of injury presented. Infant was bathed and bed change was performed several hours prior, in addition to routine hands-on care and lab draws in the preceding 12-24 hours. Unable to determine when exactly injury occurred and no other findings of concern except for bone labs...”. An electronic medical record entry revealed the parents had numerous conversations with physicians regarding cause and treatment plan with a physician who provided neonatal-specific insight into the nutritional status and increased risk of fracture in an infant with this type of medical history.The event report included information from The NICU Medical Director and Vice Chair of Quality for Pediatrics that based on Pt #2’s complicated nutritional course and suboptimal growth, this placed the patient at greater risk of osteopenia and potential bone fractures. It was decided that the injury was an unfortunate complication secondary to prematurity. On 11/29/23, a Grievance was received by e-mail. According to the information in the report, Pt #2 had been delivered prematurely and had a deformity of the leg that had been treated as a skin infection. After a week there was a fractured femur. The daughter had requested an investigation into how the baby’s femur could have been fractured. She was told that the fracture occurred because she swaddled the baby too tightly. Both the daughter and grandfather were upset, do not feel that swaddling caused the fracture, and were frustrated with the lack of communication after the fracture was discovered. Review of the grievance revealed a family meeting was scheduled to be held as a result of the grievance. Review of a note by the NICU Medical Director dated 12/2/23 revealed the family meeting had been completed on 12/1/23, attended by him/herself, the Orthopedic Surgeon, Neonatology Attending, Nurse Manager for the NICU, Nurse Practitioner Pediatric Supportive Care, mother, father, and grandfather. In the note, the physician documented that the Orthopedic surgeon explained the femur fracture resulted from a low impact injury and was not a classic pattern for force/trauma. The NICU Medical Director apologized that this had occurred to their infant, and additionally apologized that someone claimed that the mother caused this to the infant. The family asked about the frequency of femur fractures in premature infants. According to the note, the NICU Medical Director reviewed a peer jounal article that spoke to this information and to the risk of spontaneous fractures and additional risk factors Pt #2 had for metabolic bone disease of prematurity. According to the note, “...I emphasized that we have spoke with staff and reviewed the medical record. We regretfully do not know when or how this fracture occurred....The father was appropriately frustrated and described himself as “angry” that we do not know who or how this happened. He stated that DSS (Department of Social Services) would remove their child from the home if this happened as an outpatient. We apologized for this fact and acknowledge we are here to provide the best care for their son and no one would purposefully or knowingly injure their infant...”. The grievance was closed. According to the reviewer comments, the family meeting had been held 12/1 to address concerns and answer questions. Family appreciative but upset at the conclusion of meeting. During an interview on 1/6/26 at 3:20 PM, The Pediatric DON (previous Nurse Manager of the NICU) was asked about staff interviews to determine possible causes of the fracture for Pt #2. According to the DON, s/he had spoken with the night shift nurse who worked 11/22/23 into 11/23/23, who had identified the thigh swelling and possible injury on 11/23/25 at 3:18 AM. During an interview on 1/7/26 at 9:31 AM, the Pediatric DON was asked and stated s/he had also spoken with the day shift nurse who had cared for Pt #2 on 11/22/26 in the morning shift. The DON stated s/he had not spoken with anyone else and did not have written statements, but both nurses had no idea what may have happened to cause the injury. During an interview on 1/8/26 at 8:30 AM the NICU Medical Director verified the 12/2/23 meeting note for Pt #2 that documented after speaking with staff and reviewing the record, the hospital had been unable to determine the cause of the fracture. When asked which staff had been questioned as to whether they knew the cause of the fracture, the Medical Director was unsure. S/he stated that s/he had spoken with the Provider staff working that day (the fracture had been identified), and the Provider team that had done the investigation into possible medical causes of the injury; but could not confirm names or who had been spoken with. The Medical Director confirmed that the father of the child was upset that if this fracture had happened at home, DSS (Department of Social Services) would have investigated the parents for potential abuse. The NICU Medical Director stated the same non-accidental trauma (NAT) workup (medical screen) had been done for Pt #2 (with skeletal X-rays, retinal exam, and labs completed). S/he could not recall if an investigation or interviews had been done for Pt #2 regarding possible staff involvement/abuse. During a Teams (audio/video) interview on 1/8/26 at 9:35 AM, Risk Manager #11 was informed of the concern that possible causes of the fracture to include staff involvement/abuse had not been thoroughly investigated by the hospital for Pts #1 and #2. According to Risk Manager #11, they do have a suspected assault or abuse policy and staff would need to follow up on that, but once law enforcement is involved, they run the show. According to the Risk Manager, the hospital does work with law enforcement to bring in staff for interviews if needed. When informed that the law enforcement report had not been reviewed during the RCA for Pt #1 (to determine if there was information related to potential abuse by nursing staff), the Risk Manager stated that law enforcement would need to follow up with leaadership if they identify safety concerns with team members. When asked about whether the grievance filed by the grandfather of Pt #2 would have prompted the hospital to do an investigation into how the fracture had occurred, the Risk Manager stated they had linked the grievance to the fracture injury event and that had already been investigated and found to be related to nutritional issues of the critically ill. The surveyor informed the Risk Manager there was a concern for Pt #2 after the family meeting (with allegations of possible staff involvement in the injury), that there had not been a thorough investigation into what may have occurred to cause the fracture, acknowledging Pt #2 had a medical condition that may have contributed to the injury. According to the Risk Manager, if there had been more concerns after the family meeting, these would be escalated. After reviewing the note related to the family meeting, Risk Manager #11 stated, “I see what you are saying. Did we investigate from an assault or harm event? No we didn’t. We didn’t see anything to get law enforcement involved.” The Risk Manager stated that if after the meeting the family was not happy, they should contact police for alleged assault. An interview was conducted with the Director of Quality on 1/8/26 at 11:15 AM. When asked about the action the hospital would take for allegations of staff abuse of a patient, the DOQ stated they would involve law enforcement. “We- human resources would interview staff about what might have happened and staff would be removed if identified. If there was any care deviation, it would be a safety event. This would be determined by record reviews and staff interviews.” Review of the policy provided by the hospital entitled Abuse, Neglect, and Reasonable Suspicion of a Crime on Prisma Health Property” dated 11/21/25, revealed “If a patient/family or visitor makes an allegation of abuse or assault...treat any patient needs first....Enter a Safety event report detailing the alleged situation as soon as possible after patient care needs are met.....Immediate notification....Risk Management...Ensure leadership awareness...Coordinate with Security Services the interview of witnesses...Review other associated evidence/documents including the medical record...Human Resources...Work with leadership team to place involved individuals on administrative leave pending the outcome of the investigation. All allegations will be analyzed, and the appropriate corrective actions will be taken as warranted in accordance with applicable local, State, or Federal law...Leadership Team. Ensure a Safety Event Report or a Complaint/Grievance is filed. For inpatient...coordinate with Security Services and Risk Management the interview of witnessess...Investigation: All allegations of abuse, neglect or harrassment will be thoroughly investigated in collaboration with Security Services, Risk Management, Patient Advocacy, and the appropriate Leadership Team. After completing a thorough investigation, an allegation may be found substantiated, unable to be substantiated, or unsubstantiated. The event report should reflect investigation findings...”. Review of the policy provided by the hospital entitled “Recognition and Reporting of Abuse and Neglect of Children and Vulnerable Adults: Prisma Health, dated 11/21/25 revealed information that “It it the policy of Prisma Health that healthcare professionals are committed to recognizing, treating, and reporting suspected cases of abuse and neglect as outlined in the South Carolina law. Any allegations of abuse or neglect should be entered into the Prisma Health event reporting system as an event and a grievance in the complaint module...”.”

“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: 28883 Based on record reviews, review of safety events, interviews, and policy review, the hospital’s governing body failed to ensure that clear expectations for safety had been established related to the reporting and thorough investigation of allegations of staff involvement in fractures for Patients #1 and #2, 2 of 2 patients who sustained fractures while in the care of the Neonatal Intensive Care Unit. The hospital’s Administrative/Quality staff failed to perform a thorough investigation and analysis of the cause of the fractures for Patients #1 and #2 in relation to the allegations of staff invlolvement/abuse. The findings included: Cross Refer to A-145, Patient Rights, Free from Abuse and Harassment. Record review on 1/6/26 and 1/7/26 revealed Pt #1 was admitted to the hospital’s NICU on 8/10/25 with a Right Pneumothorax. An X-ray showed a right humerus fracture on 8/17/25. The cause of the fracture for Pt #1 was determined to be inflicted, with motive (accidental or on purpose) unknown. An allegation of possible staff involvement in the fracture for Pt #1 was documented in a Social Work note dated 8/18/25 at 4:15 PM, “...Parents concerned about pt’s injury and that s/he could have been hurt by staff...”. This allegation had not been reported into the hospital’s safety event reporting system as per policy. Interviews had been conducted by the Nurse Manager of the NICU with the nursing direct care staff taking care of Pt #1 about possible injury during care. The hospital’s law enforcement had conducted an investigation into possible criminal conduct and had interviewed the direct care nursing staff taking care of Pt #1, but the information in the report had not been reviewed in the hospital’s analysis of possible causes/contributing factors of the fracture. The police report could have contained information as to a possible cause. Other staff not providing direct care but who were working and may have seen or heard something had not been interviewed about knowledge of possible staff involvement in the injury. During an interview on 1/7/26 at 11:49 AM, the surveyor reviewed the Root Cause Analysis (RCA) documentation with Patient Safety Partner #10, which included a timeline of events for Pt #1 to include an analysis of medical procedures for Pt #1 from delivery to admittance to hospital #2, chest tube insertions and removal, and the chest X-rays and identification of the humerus fracture. They had reviewed forensics, orthopedic, and ophthalmologic notes, labs, and noted that law enforcement and DSS referrals had been made. A Magnetic Resonance Imaging (MRI) report of the head (For Pt #1) was reviewed. On 9/11/25, they discussed contributing factors which they identified as environmental/staffing with a discussion of the curtain pulled while family was in the room with Pt #1. They discussed that there had been no targeted place to document staff interactions between the patient and family, and no place to document the family history of domestic abuse that may have led to this or the speculation of a possible genetic disorder. There was no root cause identified at this point because it was all speculation. During the action planning meeting on 9/16/25, they reviewed contributing factors. Based on the review, the corrective action they decided on was to bring the pediatric nursing service office (NSO) a proposal to introduce a place where nurses could document/communicate observations of interactions with family of patients seen during the shift so the Providers could also see; because they were not sure what the family was doing behind the curtains. The corrective action due date was 12/17/25. At the last NSO meeting, it was decided to implement the plan and a flyer was created by 12/31/25 to educate the staff in the NICU. The next meeting was planned to be on 1/19/25 to wrap up the plan and make sure the information about the place for nursing documentation was getting disbursed. When asked about the discussion of contributing factors, Patient Safety Coordinator #10 stated that the curtains were snapped closed while family was in the room which was unusual and the staff could not visualize the parents all the time. In ensuring privacy of all parents the hospital encourages a culture of patrents caring for the infants on their own. There would have been no indciation to have had the curtains open and no indication for the team to have the curtains open. Other speculative factors were discussed which included a family history of domestic abuse and possible connective tissue disorders. When asked about whether staff involvement in the fractures/possible abuse by staff had been considered, the safety coordinator stated it hadn’t as there were no concerns with the care provided by the hospital staff and no indication that something had happened during the care by the staff. When asked how this event review gets to quality, Patient Safety Coordinator #10 stated that quality staff are given a summary of the findings from the RCA. Once a month they do review events identified as serious safety events to include contributing factors and action plans. Since s/he is not a part of the hospital staff at hospital #2, s/he would not attend the quality meetings for this event. A phone interview was conducted with Patient Safety Coordinator #10 on 1/7/26 at 1:14 PM. S/he was asked if the police report of interviews with staff had been available to the team and discussed during the RCA meetings. According to the Safety Coordinator, the police report findings had not been available or reviewed during the RCA meetings. A Teams (audio/video) call was conducted with Risk Manager #11 on 1/8/26 at 9:35 AM. The Risk Manager confirmed s/he had requested the police report (dated 8/28/25 by Officer #20) related to the fracture of unknown origin for Pt #1 from the Greenville Health Authority upon request from the surveyor and provided it during the survey. The surveyor informed the Risk Manager of the concern that the police report had not been available during the administrative review/Root Cause Analysis meeting to see if there was additional information from the police interviews that could assist in determining possible causes of the fracture for Pt #1. The police report may have included information about possible staff involvement in the injury that the nurses had not mentioned to the Nurse Manager. According to the Risk Manager, law enforcement would need to follow up with leadership if they identify safety concerns with team members. During an interview on 1/8/26 at 11:15 AM, the Director of Quality stated that the event for Pt #1 was not determined to be a serious safety event. It would only be determined a serious safety event if deviations from the standard of care had been identified after interviews and record reviews. Review of Quality meeting minutes revealed nothing to indicate this event had been reviewed. The Director of Quality stated the event report for Pt #1 (fracture) had not been reviewed in Quality meetings and the plan was to review the completed action plan (new documentation for staff in the NICU) after it had been implemented later this month. The quality team would then look at the action plan to see if they needed to make adjustments and ensure it was measurable and adhered to. Education of the nursing staff on the plan for the new way/entry to document pertinent events so that other staff could be aware had started in January 2026. Thirty NICU nurses had done the read sign education and 10 people had completed the education by e-mail; with a total of 1/3 of the staff having been educated so far. Pt #2 was admitted on 10/2/23 with Prematurity and Respiratory Immaturity. An X-ray on 11/23/23 showed a right femur fracture. The injury was sustained while receiving care in the hospital’s NICU. A medical cause of the fracture (osteopenia of prematurity) was determined for Pt #2. This had been discussed with the Pt #2’s family. On 11/29/23, a Grievance was received by e-mail. According to the information in the report, Pt #2 had been delivered prematurely and had a deformity of the leg that had been treated as a skin infection. After a week there was a fractured femur. The daughter had requested an investigation into how the baby’s femur could have been fractured. During an interview on 1/6/26 at 3:20 PM, The Pediatric DON (previous Nurse Manager of the NICU) was asked about staff interviews to determine possible causes of the fracture for Pt #2. According to the DON, s/he had spoken with the night shift nurse who worked 11/22/23 into 11/23/23, who had identified the thigh swelling and possible injury on 11/23/25 at 3:18 AM. During an interview on 1/7/26 at 9:31 AM, the Pediatric DON was asked and stated s/he had also spoken with the day shift nurse who had cared for Pt #2 on 11/22/26 in the morning shift. The DON stated s/he had not spoken with anyone else and did not have written statements, but both nurses had no idea what may have happened to cause the injury. All staff that may have been working around the timeframe of Pt #2’s fracture and may have seen or heard something that might have added information to an investigation of possible staff involvement in the injury had not been interviewed Review of a note by the NICU Medical Director dated 12/2/23 revealed a family meeting had been completed on 12/1/23. In the note, the physician documented that the Orthopedic surgeon explained the femur fracture resulted from a low impact injury and was not a classic pattern for force/trauma. According to the note, the NICU Medical Director reviewed a peer jounal article that spoke to the risk of spontaneous fractures and additional risk factors Pt #2 had for metabolic bone disease of prematurity. “...I emphasized that we have spoke with staff and reviewed the medical record. We regretfully do not know when or how this fracture occurred....The father was appropriately frustrated and described himself as “angry” that we do not know who or how this happened. He stated that DSS (Department of Social Services) would remove their child from the home if this happened as an outpatient. We apologized for this fact and acknowledge we are here to provide the best care for their son and no one would purposefully or knowingly injure their infant...”. . During an interview on 1/8/26 at 8:30 AM the NICU Medical Director verified the 12/2/23 meeting note for Pt #2 that documented after speaking with staff and reviewing the record, the hospital had been unable to determine the cause of the fracture. When asked which staff had been questioned as to whether they knew the cause of the fracture, the Medical Director was unsure. S/he stated that s/he had spoken with the Provider staff working that day (the fracture had been identified), and the Provider team that had done the investigation into possible medical causes of the injury; but could not confirm names or who had been spoken with. The Medical Director confirmed that the father of the child was upset that if this fracture had happened at home, DSS (Department of Social Services) would have investigated the parents for potential abuse. The NICU Medical Director stated the same non-accidental trauma (NAT) workup (medical screen) had been done for Pt #2 (with skeletal X-rays, retinal exam, and labs completed). S/he could not recall if an investigation or interviews had been done for Pt #2 regarding possible staff involvement/abuse. The Medical Director was informed there was a concern that although a medical condition for the fracture had been identified, there still could have been staff involvement in the injury including possible staff abuse or accidental injury that had not been thoroughly investigated. A Teams (audio/video) call was conducted with Risk Manager #11 on 1/8/26 at 9:35 AM. When asked about whether the grievance filed for Pt #2 would have prompted the hospital to do an investigation into how the fracture had occurred, the Risk Manager stated they had linked the grievance to the fracture injury event and that had already been investigated and found to be related to nutritional issues of the critically ill. The surveyor informed the Risk Manager there was a concern for Pt #2 after the family meeting (with allegations of possible staff involvement in the injury), that there had not been a thorough investigation into what may have occurred to cause the fracture, acknowledging Pt #2 had a medical condition that may have contributed to the injury. According to the Risk Manager, if there had been more concerns after the family meeting, these would be escalated. After reviewing the note related to the family meeting, Risk Manager #11 stated, “I see what you are saying. Did we investigate from an assault or harm event? No we didn’t. We didn’t see anything to get law enforcement involved.” The Risk Manager stated that if after the meeting the family was not happy, they should contact police for alleged assault. An interview was conducted with the Director of Quality on 1/8/26 at 11:15 AM. When asked about the action the hospital would take for allegations of staff abuse of a patient, the DOQ stated they would involve law enforcement. We- human resources would interview staff about what might have happened and staff would be removed if identified. If there was any care deviation, it would be a safety event. This would be determined by record reviews and staff interviews. During an interview on 1/8/26 at 11:35 AM, Pt Safety Partner #12 stated there had been no Root Cause Analysis done by administrative staff for Pt #2 as it had not been determined to be a safety event. No deviation in care had been noted during review of the event. The Safety Partner confimred there had been no investigation into what had actually happened during the course of hospitalization to cause the fracture. It was an unfortunate complication of the infant’s prolonged need for nutrition and metabolic disease. When asked who would need to identify whether staff interviews needed to be collected to determine what had actually happened to cause the fracture (whether staff involvement that may have been accidental or abuse), the Safety Partner stated Provider leadership would need to direct staff to perform additional interviews; that Provider leadership is relied on for their expertise. Review of the policy provided by the hospital entitled Patient Rights and Responsibilities: Prisma Health, dated 5/11/22, “It is the policy of Prisma Health to respect the rights of patients in accordance with the Statement of Patient Rights and Responsibilities...Your rights include the following: ...Receiving care in a safe setting, free from all forms of abuse or harrassment...”.”

“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: 28883 Based on record reviews, interviews, and review of hospital policy, nursing staff failed to timely place reports of fractures of unknown origin into the hospital’s safety event reporting system for Patients #1 and #2, 2 of 2 infants reviewed with fractures identified while under the care of the hospital’s Neonatal Intensive Care Unit (ICU). The findings included: Review on 1/6/25 of the safety event report for Pt #1 revealed information that on 8/17/25 at 8:50 AM, Pt #1 had limited movement in the right arm, X-ray confirmed right humerus fracture. According to the documentation, this information had been placed into the hospital’s event reporting system on 8/18/25. The form indicated there had been “harm” for Pt #1. The form indicated a “Master Landing Page Site Guest User” had inputted information on 8/18/25 at 2:12 PM. During an interview on 1/6/26 at 12:26 PM, the Pediatric Director of Nursing verified the fracture of unknown origin was identified for Pt #1 on the morning of 8/17/25. When asked when it had been placed into the hospital’s safety event reporting system, the Pediatric DON stated it was put in on 8/18/25 by Charge Nurse #7. The DON stated there was no time documented for when the entry was inputted. When asked why the safety event report had not been put in the system on 8/17/25, the Pediatric DON was unsure, other than the nursing staff had been busy taking care of the baby. Review on 1/8/25 of the safety event report for Pt #2 revealed information that on 11/23/23 at 9:00 AM, Pt #2 was found with swelling of the right leg. An X-ray was ordered and right femur fracture noted. The form indicated there had been “harm” for Pt #2. During an interview on 1/8/26 at 9:35 AM, Risk Manager #11 verified the fracture of unknown origin had been identified for Pt #2 by nursing staff on the morning of 11/23/23. When asked when the event report had been placed into the hospital’s safety event reporting system, the Risk Manager stated it was put in by a nurse on 11/25/23. During an interview on 1/8/26 at 10:42 AM, the Pediatric DON was asked how soon incidents like fractures of unknown origin need to be placed in the hospital’s event reporting system. The DON stated s/he would have to defer to policy. The DON verified the report of fracture of unknown origin had not been put into the reporting system until 11/25/23. Review of the policy provided by the hospital entitled “Safety Event Reporting: Prisma Health”, dated 7/24/25 revealed that the hospital system is committed to a culture of shared learning and encourages reporting of safety events and great catches (near misses and hazardous conditions). The purpose of this policy is to provide clarity on the Pulse Power reporting process, to include events to report, accountability for management of reported events and the role of patient safety in oversight of reported event. A reportable event is any incident involving a near miss, safety event, or unsafe condition. The policy defined a safety event as an event, incident, workplace violence, or condition that could have resulted or did result in harm to a patient, visitor, or team member. According to the policy, the individual first aware of the reportable event will complete the event report in the Safety Event Reporting tool/Pulse Power located on the Prisma Health intranet as well as an application of Prisma Health computer desktops. “Team members are encouraged to report the event by the end of their shift or within 24 hours of occurrence....”.”

“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: 52713 Based on interviews, record review, and review of the facility’s policies/procedures, both Registered Nurse #1 (RN)1 and Scrub Technologist (ST) failed to properly execute the initial, closing, and/or final surgical counts, which resulted in a retained laparotomy (abdominal surgery) sponge inside the body cavity of Patient #1 (P)1, one of nine patients reviewed for exploratory (opened, body cavity) surgical procedures. The findings include: Cross Reference A-0951 Surgical Services: Delivery of Service”

“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: 52713 Based on interviews, record review, and a review of the facility’s policies/procedures, both Registered Nurse #1 (RN)1 and Scrub Technologist (ST) failed to follow the facility’s policy regarding surgical counts. Both RN1 and ST failed to ensure that the initial, closing, and/or final counts were properly executed, which resulted in a retained laparotomy sponge inside the body cavity of Patient #1 (P)1, one of nine surgical patients reviewed whom underwent exploratory procedures. The findings include: Review of P1’s record on 9/9/25 at 11:16 AM revealed that he/she was admitted to the facility on 8/13/25 with abdominal pain. A computed tomography (CT) scan was done which revealed abnormal findings “suggestive of possible pneumatosis [presence of air or gas in an abnormal location within the body] and portal venous gas”. As a result of these findings, Medical Doctor #1 (MD)1, along with Resident #1 (R)1, performed an emergency exploratory laparotomy [open abdominal surgical procedure] on P1 during the early morning hours of 8/15/25. Review of the intraoperative record revealed Registered Nurse #1 (RN)1 documented the initial, closing, and final counts were correct and verified during P1’s surgical procedure, by both RN1 and ST. An operative note, documented by R1 on 8/15/25 at 3:23 AM, indicated, “the midline was closed... The patient emerged from anesthesia and was taken to PACU [Post-Anesthesia Care Unit] in stable condition. All counts were correct. [MD1] was present and participated in the entire case”. An interview was conducted on 9/9/25 at 9:35 AM with MD1. He/she identified as the trauma surgeon, who performed P1’s exploratory laparotomy on 8/15/25. MD1 stated that P1 “needed to have an emergency exploratory laparotomy performed for possible bowel ischemia [inadequate blood supply to an organ or tissue]”. During the case, MD1 identified that he/she conducted a timeout before an incision was made, before closing, and after the procedure was done. In asking MD1 about the correct call of the counts, he/she identified that Registered Nurse #1 (RN)1 stated that the counts were correct. MD1 stated that the facility has a gastrointestinal bleed (GI) protocol in place for patients with suspected GI medical concerns. MD1 stated that on 8/19/25, he/she was notified that there was a “retained item” in P1 after receiving a second CT scan, in reference to the GI protocol. MD1 identified that he/she performed another exploratory laparotomy on P1 to retrieve the retained item on 8/19/25. MD1 revealed that the foreign object was a laparotomy sponge. After the sponge was retrieved, an X-Ray was done, before closing the body cavity, to ensure that all foreign bodies were removed. MD1 mentioned that P1 has had prior abdominal surgeries in the past, that involved implantation of mesh [implantation of a medical device to reinforce weakened or damaged tissue]. When asked if this laparotomy sponge could have been left inside of P1 during a prior procedure, he/she replied, “No”. Review of Resident #2 (R)2’s operative note, dated 8/19/25 at 9:11AM, revealed that “.... the peritoneal cavity was entered safely ...in the lower abdomen, a single lap [laparotomy sponge] was removed ...abdominal x-ray was obtained with confirmation by the radiologist that there were no retained foreign bodies... At the conclusion of the case all sponge, needle, instrument counts were correct ... Please note [MD1] was present and scrubbed for the entirety of the procedure”. An interview was conducted with RN1 on 9/9/25 at 10:35AM. RN1 stated he/she worked 7PM-7AM on 8/14/25. RN1 described the shift as a “hectic and busy night” as the operating room had trauma surgeries prior to the procedure involving P1. RN1 revealed that an initial sponge count was done before the patient arrived to the operating room. RN1 stated that he/she counted initial, closing, and final sponge counts only with the ST. RN1 identified that he/she used a “sponge-counting hanging bag” to separate the soiled sponges. RN1 further elaborated that during the closing count, he/she physically pointed and verbalized each lap sponge, as “1, 2, 3, 4 ....”. RN1 stated that the laparotomy sponges used came with the sterile pack kit that was used for the procedure. RN1 stated that he/she placed each sponge in the hanging bag as they were thrown in a kick bucket by the sterile field. RN1 mentioned that he/she, in addition to anesthesia, were the only unsterile personnel in the room and no one else could have opened up additional sterile items. RN1 insisted that he/she counted the correct amount of lap sponges during the initial, closing, and final counts. Review of the facility’s policy, “Universal Protocol: Prisma Health”, effective 10/20/2024, of section 3.5, revealed that the debriefing timeout (before surgeon/proceduralist and patient leave the procedure area) should include specific items. Section 3.5.1.1 identified that the debriefing count should include, “Notification of the team regarding the results of the counts, including instruments, sponges, and needles”. Review of the facility’s policy, “Surgical Counts and Prevention of Retained Surgical Items: Prisma Health”, effective 9/5/2023, identified that when surgical procedures are performed at Prisma Health, all sponge, sharp and other miscellaneous items should be counted unless identified in the exception listing .... This recommended practice provides guidance for the surgical and procedural personnel to prevent unintended retained surgical items ... Section 1 of the policy mentioned that all perioperative team members will engage in safe practices that support the prevention of retained surgical items ... “2. Any item that is added to the sterile field with the potential to be retained in the surgical wound must be accounted for its entirety and be added to the count sheet .... 2.1. Counts will be recorded in a location visible to the entire surgical team, including staff scrubbed in at the surgical site (e.g., whiteboard on the wall) .... 3.1. Hanging count bags will be used to track soft goods removed from the sterile field .... 4. A standardized count procedure following the same sequence assists in achieving accuracy, efficiency, and continuity among team members .... 4.1. Counts are to be completed in the following organized fashion to prevent items from being counted twice: sterile field, mayo stand, back table, kick bucket, count bags, then other items removed from the field ... 5. Counts should be performed audibly and visually between two individuals; one (1) must be a Registered Nurse (RN). Typically, the surgical tech serves as the second individual in a surgical setting since they are responsible for the sterile field ... 8. The following items require counting, but are not limited to ... 8.1. Soft goods: Sponges, lap pads, towels (radiopaque), cottonoids, tonsil sponges, linen shods, dissectors (kittners), throat packing, vaginal packing ... 9. Counts are to be performed at the following times ... 9.1. Initial counts: Prior to the incision to establish a baseline, preferably before the patient enters the room if possible ... 9.2. Closing counts: Before closure of a cavity or hollow organ (i.e., peritoneum, uterus, bladder, thorax), wound, or dura begins .... 9.3. Final counts: At the beginning of skin closure, or prior to the sealing of a wound vac or open abdominal dressing .... 9.3.4. Notify the licensed practitioner of the correct count ... 9.6. Verification of the initial, closing, relief, and final counts should be documented in the medical record (MR)”.”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 28883 Based on record reviews, interviews, and review of the hospital policies, the hospital failed to ensure nursing staff provided appropriate wound care services for 7 of 7 patients reviewed with pressure ulcers developed at the hospital: Patients (P) #1, #2, #3, #4, #5, #6, and #7. The findings included: Cross refererence A-398 Supervision of Contract Staff”

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 28883 Based on record reviews, interviews, and policy review, the hospital nursing staff failed to provide and document appropriate interventions to prevent the development of or worsening of pressure ulcers for 7 of 7 patients reviewed, Patients (P) #1, #2, #3, #4, #5, #6, and #7. The floor nursing staff either failed to provide or document the placement of specialty boots used for the prevention of or worsening of heel ulcers, failed to document accurate nursing skin assessments related to a description of the wounds and/or wound care provided as ordered, and/or failed to provide treatment or obtain physician orders for treatment on identification of wounds. The findings included: P5. Record review on 7/28/25 at 2:03 PM revealed P5 was admitted to the hospital on 4/16/25 with a diagnosis of acute traumatic spinal cord injury with possible brain injury after a motor vehicle collision. A History and Physical dated 4/16/25 at 2:02 PM indicated P5 had profound mobility and self-care deficits. The Provider note indicated P5 was at high risk for pressure ulceration and that P5 would need skin checks every shift and pressure relieving interventions. Review of the Admission nursing assessment dated 4/16/25 at 3:00 PM revealed no indication of a pressure injury to the heels. Nursing documentation dated 4/22/25 at midnight indicated a deep tissue injury (DTI - type of pressure wound that occurs when prolonged pressure damages the underlying tissues) to the left heel with a reddened wound bed. The wound was left open to air (no new wound care was provided or ordered.) On 04/23/25 at 11:58 AM, the Wound Care Nurse (WCN) documentation indicated the wound bed was a maroon, non-blanchable (skin remains red when pressure is applied) DTI measuring 1 centimeter (cm) x 8 cm x 2 cm. There was a physician’s order on 4/23/25 at 12:17 PM for daily wound care to cleanse both heels with saline, apply Venelex (cream), and cover with a foam border dressing. There was no documented evidence the wound care was provided on 4/27/25, 5/2/25, 5/3/25, and 5/6/25. Nursing documentation on 5/7/25, 5/9/25 and 5/10/25 indicated the dressing was changed but there was no documentation of what wound care was provided. During a concurrent interview with Safety Partner 2 (SP2), she/he confirmed the findings. Continued review of P5’s record revealed a WCN note dated 5/12/25 at 2:17 PM indicated the left heel was now unstageable (full-thickness skin and tissue loss that is fully or partially covered by dead tissue) and measured 3 cm x 2.2 cm x 0.1 cm with extensive slough (dead tissue). New wound care orders on 5/12/25 at 2:55 PM, indicated to cleanse the left heel with saline or wound cleanser, apply Cavilon (protectant) no sting skin barrier to the peri-wound, Medi honey to wound base, cover with Aquacel AG (alginate - promotes healing), secure with Mepilex foam border (dressing) and change daily and as needed. There was no documented evidence the wound care was provided on 5/13/25 and 5/16/25. SP2 confirmed the findings in a concurrent interview. Continued review of P5’s record revealed on 5/19/25 at 9:35 AM, a new physician’s order indicated to cleanse the left heel with saline or wound cleanser; Apply Cavilon no sting skin barrier to the peri-wound to protect it from maceration; Apply Dakins (antiseptic solution) moistened 2x2 gauze to the wound bed (fold in half so moist gauze is not sitting on good skin): Secure with a foam border dressing and change twice daily (BID) and as needed. There was no documented evidence the wound care was provided on 5/27/25. There was no documented evidence the wound care was provided BID on 5/23/25, 5/24/25, 5/28/25, 5/30/25, 5/31/25, 6/1/25, 6/2/25, 6/3/25 and 6/4/25. Continued review of P5’s record revealed nursing staff failed to document accurate skin assessments of the left heel wound every shift to include a description of the wound as per policy for the following dates/shifts: 4/23/25 for the PM shift, 4/25/25 for the PM shift, 4/26/25 for the PM shift, 4/27/25 for the AM and PM shift, 4/29/25 and 5/24/25 for the PM shift, and on 5/27/25, 5/31/25, 6/1/25, 6/2/25, 6/3/25, and 6/4/25 for the AM and PM shifts. During an interview with SP2 on 7/30/25 at 11:30 AM, she/he confirmed the findings. In a concurrent interview with SP2, she/he stated the expectation was the nursing staff should look at the wound and documenting what it looks like. Continued review of P5’s record on 7/30/25 at 11:21 AM revealed physician orders dated 4/16/25 at 1:59 PM for P5 to wear PRAFOs (Pressure Relief Ankle Foot Orthoses). Review of the nursing documentation on the flowsheets from 4/16/25 through 6/5/25 revealed no documented evidence the PRAFOs were in place on 4/24/25, 4/26/25, 4/27/25, 4/28/25, 4/29/25, 4/30/25, 5/2/25, 5/4/25, 5/5/25, 5/6/25, 5/7/25,5/8/25, 5/9/25, 5/10/25, 5/14/25, 5/15/25, 5/23/25, 5/25/25, 6/1/25, 6/2/25, 6/3/25, 6/4/25, and 6/5/25. During an interview on 7/30/25 at 11:30 AM, SP2 verified the findings. According to SP2, nurses should document if the patient has them on while in bed. 2. Patient 6 (P6) - Record review on 7/29/25 at 2:00 PM revealed P6 was admitted on 4/3/25 with a diagnosis of pulmonary infarcts (a blockage of blood causing lung tissue to die). A stage 3 (full-thickness skin loss with visible subcutaneous fat) to stage 4 (wound extending to bone, tendon and/or muscle) sacral (tailbone) wound was identified on admission. A foam border dressing (absorbent wound dressing) was placed over the wound, and an order was placed on 4/4/25 at 9:58 AM for a wound care consultation of the sacral wound. On 4/4/25 at 1:54 PM, a Wound Care Nurse (WCN) documented P6 was having a procedure and the consultation could not be completed at that time and follow up would be done the next week as the schedule allowed. There was no documented evidence of any attempts to contact a Provider for wound treatment orders in the meantime. On 4/4/25 and 4/5/25 the foam border dressing (absorbent and protective dressing) was changed and no other treatment was documented. On 4/7/25, a PolyMem dressing (cleansing, moisturizing and absorbent wound dressing) and foam border dressing were placed on the wound. On 4/7/25, a WCN assessed P6’s sacral wound (three days after the order) and documented a stage 3 pressure wound to the sacrum with the wound bed moist, non-blanchable, open, painful, pink, red, and ulcerative with a saturated dressing. On 4/7/25 at 12:27 PM there was an order for wound care as follows: Cleanse the sacrum with bath wipes after incontinence episodes and remove the soiled zinc paste cream and apply a thin layer of Critic Aid thick moisture barrier paste; No cover dressing needed; At least once per shift when assessing the skin, gently remove all paste using foaming cleanser and washcloth; Assess the skin and document findings; Apply a thin layer of Critic Aid thick moisture barrier paste. Continued review of P6’s record revealed no documented evidence the nursing staff followed the physician’s orders for P6’s sacral wound as follows: On 4/7/25 no zinc paste was removed/reapplied; On 4/8/25 no critic aid barrier paste was applied; On 4/9/25 the nurse documented changing a saturated sacral dressing but the physician’s order was for no dressing; On 4/10/25 PM shift and 4/11/25 AM shift, no application/removal of barrier paste; On 4/13/25 and 4/14/25 PM shifts, no treatment provided. On 4/15/25 AM shift, no barrier cream removed/reapplied; On 4/15/25 PM shift no treatment provided; On 4/16/25 PM shift, no barrier cream applied; On 4/17/25 and 4/18/25 PM shifts, no treatment provided; and on 4/20/25 AM shift, no treatment provided. From 4/23/25 through 4/29/25, nursing staff either failed to document a description of the wound and/or the removal/application of the barrier paste to the wound every shift. No nursing skin assessments were documented on 4/7/25 PM shift; 4/8/25 and 4/9/25 AM and PM shifts; 4/10/25 PM shift; 4/11/25 AM shift; 4/13/25 and 4/14/25 PM shift; 4/15/25 PM. In an interview with Nurse Manager 6 (NM6) on 7/29/25 at 2:30 PM, she/he verified the findings. On 4/23/25 at 11:30 AM, the WCN assessed the wound and measured the wound at 3 cm x 6 cm x 0.2 cm. Orders were changed to cleanse the area with bath wipes or normal saline gauze and use a thickness of a dime of Triad (zinc oxide paste) wound cream to cover the affected area. Review of the nursing documentation revealed wound treatment orders were not completed as follows: On 4/30/25 at 12:41 PM, the nurse used moisturizing cream instead of the Triad cream; From 5/1/25 through 5/6/25, nursing staff either failed to document the treatment provided to the wound and/or a description of the wound for each shift. During an interview on 7/29/25 at 3:20 PM, NM3 verified the findings. Continued review of P6’s record was conducted on 7/29/25 at 3:30 PM with NM6. A pressure injury wound was documented on 5/11/25 at 3:00 PM on the LDA (lines, drains and airways avatar in the electronic medical record). An order for a WCN consultation was placed on 5/12/25 at 10:51 AM to evaluate and treat the left heel wound. There was no documentation of treatment provided or an attempt to get orders for treatment until the WCN saw the patient on 5/14/25. The WCN’s assessment on 5/14/25 at 11:20 AM indicated a stage 3 to the left heel measuring 2 cm x 3.5 cm x 0.1 cm. Nursing staff failed to identify any alterations in skin integrity for the left heel prior to 5/11/25 when a stage 3 pressure injury appeared to the left heel. After identification of the wound to the left heel on 5/11/25, review of the nursing skin assessments revealed multiple days and shifts without documentation of the wound and/or nursing assessment of the wound as follows: Nursing assessments dated 5/11/25 at 8:00 PM, 5/12/25 at 7:44 AM, 5/12/25 at 9:58 PM, 5/13/25 at 8:48 AM, 5/13/25 at 8:56 PM, and 5/14/25 at 8:25 AM revealed nothing was documented to show a problem with the skin on the left heel. After the WCN assessment of the left heel stage 3 wound on 5/14/25, there was no nursing assessment of the wound on 5/14/25 at 8:00 PM, on 5/15/25 at 7:30 AM, 9:30 AM, and 7:30 PM. In concurrent interview, NM6 verified the findings. Continued review of P6’s record with NM6 on 7/29/25 revealed, on 5/14/25 at 2:05 PM, wound care was ordered which included to cleanse the left heel with bath wipes: Apply liquid skin barrier to the peri wound and apply PolyMem cut to fit; Secure dressing with border foam; To be done daily and as needed; and Use Tru Vue boots (for heel protection). Review of the documentation revealed multiple instances of limited/missing documentation of the use of the Tru Vue boots. Review of treatments by the floor nursing staff revealed no documentation of treatment provided to the left heel wound on 5/17/25 and 5/18/25. The findings were verified by NM6 during a concurrent interview. P7. Record review on 7/29/25 at 9:36 AM with NM5 revealed P7 was admitted to the hospital on 4/8/25 with diagnoses including Liver Failure, Acute Kidney Injury, Shock (life-threatening condition caused by lack of blood flow to the body), and Sepsis (a life-threatening systemic infection). On 4/8/25 at 8:00 PM, nursing documented a foam border dressing on the sacrum for prevention of pressure injury. Six days later, on 4/14/25 at 7:00 AM, a nurse documented a pressure injury to the midline sacrum and a WCN consultation was ordered for validation of pressure injury wound staging. The nurse sent a photo of the sacrum to the WCN, who responded that it appeared to be a stage 1 (superficial redness of intact skin), and to continue with turning every two hours and to apply a foam border dressing for protection. On 4/17/25 at 3:13 AM, an open area to the sacrum was documented and a dressing was applied but there were no measurements, no wound treatment documented, and the type of dressing was not documented. On 4/17/25 at 8:25 AM, a nurse documented redness to the sacrum, with a dressing intact. There was no documentation of a treatment being completed. On 4/18/25, 4/19/25, and 4/20/25, there was no documentation of a wound treatment. There was no documentation of communication with a Provider to obtain orders for treatment after the wound was observed to be open on 4/17/25. On 4/22/25 at 10:00 AM, a WCN saw the patient and documented a stage 2 pressure injury wound to the sacrum. The WCN recommended Critic Aid (thick moisture barrier paste with zinc oxide) for protection from incontinence. Review of physician orders revealed an order dated 4/22/25 at 12:54 PM for wound care to the sacrum, to cleanse with a bath wipe as needed after incontinence episodes; Remove only zinc paste soiled; Apply thin layer of Critic Aid thick moisture barrier paste; Then at least once per shift when assessing the skin, remove all zinc paste using a generous amount of foaming cleanser and moistened washcloth; Assess the skin and document findings; Apply a thin layer of Critic Aid thick moisture barrier paste. On 4/22/25 for the PM shift, the floor nurse failed to document an assessment of the sacral wound or that zinc paste was removed or reapplied. On 4/23/25 for the PM shift, there was no wound assessment documented by the floor nurse, nor indication that zinc paste had been removed or reapplied. On 4/24/25 for the AM shift, there was no documentation of a sacral wound assessment. On 4/25/25 for the PM shift there was no documentation of a sacral wound assessment. On 4/26/25 for the AM shift there was no documentation of a sacral wound assessment nor indication that zinc paste had been removed or reapplied. During an interview on 7/29/25 at 11:30 AM, the findings listed above were verified by NM5 who stated nurses should know to do an assessment of the wound once a shift. On 4/29/25 at 1:00 PM, P7 was transferred to the rehabilitation unit and the nursing skin assessment indicated the sacral wound was unstageable. A WCN assessment was completed on 4/30/25 at 10:27 AM, with the wound bed with slough, painful, pink, red, moist, and open with serosanguinous drainage. A physician’s order on 4/30/25 at 10:30 AM, indicated to cleanse with saline or wound cleanser; Apply no sting skin prep barrier to peri wound; Medi honey to wound base; Cover with Aquacel AG; Secure with Mepilex foam border; Change daily and as needed. There was no documented evidence the wound care was provided as ordered on 5/2/25 and 5/3/25. On 5/4/25 at 5:00 PM, the nurse failed to document what products were used for treatment. On 5/9/25, 5/13/25, and 5/14/25, nursing staff failed to document a dressing change to the sacrum and/or an assessment of the wound. The findings were verified by NM5 during an interview on 7/29/25 at 12:04 PM. Review of the hospital’s policy titled, “...Skin Care Orders and Treatment Guidelines, Adult,” dated 09/24/24, revealed, “Pressure Injury and/or Surgical Wounds...For all wounds without existing orders: ...3. Initiate Pressure Ulcer Prevention Plan if Braden Score is <19. 3.1. If possible, off-load pressure to the area. Example: if wound is on sacrum, then turn patient from right to left only and avoid positioning on back. 3.2 Order a low air loss mattress for any patient with a Braden score <13. ...3.3 Float heels and reposition heels each time patient is turned and/or repositioned. 3.4 Consult dietitian for nutritional deficits, Review of the hospital’s policy titled, “Skin Care Orders and Treatment Guidelines, Adult,” dated 09/24/24, revealed: poor oral intake, or Braden nutritional sub- score <3. ...4. Notify Authorized Practitioner (AP) of all wounds. 5.Consult WOC nursing for all suspected pressure injuries. 6. Reconsult WOC and notify AP if no improvement is noted within 7 days of treatment or at any time if condition worsens...” Review of the hospital’s policy titled, “Pressure Injury and/or Surgical Wounds” revealed, “...care practices are employed to prevent skin breakdown by assessing for and identifying at risk patients. When identified, interventions to reverse tissue damage, prevent further damage and maintain an optimal wound environment for healing are utilized...Procedural Steps: 1. Initial Integumentary Physical Examination 1.1. The initial head to toe integumentary physical examination including visualization and palpation of all bony prominences is preferably completed within four (4) hours of admission/transfer to another unit, but not to exceed twenty-four (24) hours after admission. 1.1.1. This integumentary physical examination should be completed by two (2) licensed nurses, one of whom must be a Registered Nurse. Document any findings in the medical record. ...1.4. Implement preventative measures for all patients identified as high risk for skin breakdown. 1.4.1. For perioperative and procedural areas, implement preventative measures based on the length of the procedure or surgery and/or positioning required to conduct the procedure or surgery. 1.5. If pressure injuries or other wounds are present on admission, document the characteristics, location, pressure injury staging as applicable, measurement, presence of staples or sutures, presence of tubes or drains and appearance including condition of surrounding skin, in the medical record and notify the AP as applicable. 1.6. Consult the Wound/Ostomy Nurse where available, at minimum for pressure injuries identified as stage three, stage four, unstageable injuries, and/or deep tissue injuries. 1.7. An AP order is required for wound treatment, management, or a wound culture. 2. Follow-up Integumentary Examination 2.1. Perform integumentary physical examination at minimum every shift and complete pressure injury risk scale daily at minimum. 2.1.1 Patients returning from surgery should have an integumentary examination completed as part of the post-surgical assessment including post anesthesia care unit (PACU). 2.2 Document any wound(s) to include characteristics, location, and appearance including condition of surrounding skin, pressure injury staging as applicable, measurement, presence of staples or sutures, presence of tubes or drains and condition of dressing if applicable in the medical record. 2.2.1 For wounds with dressings that cannot be removed each shift, document the above criteria with dressing change weekly at minimum. 2.3 Notify the AP if there is undesirable change in a wound.” 30260 P1. During an interview and review of the electronic medical record (EMR) on 07/29/25 at 2:56 PM the Nurse Manager of the surgical specialty unit (NM) 3 stated P1 presented to the emergency department (ED) on 01/31/25 with a chief complaint of acute onset of the left lower extremity weakness and pain and was admitted to the surgical specialty unit on 02/04/25. Review of the EMR nurse’s flowsheet revealed that on 02/04/25 at 9:45 PM, a nurse documented a two - person skin assessment but there was only one name on the assessment. NM3 acknowledged there was only one nurse’s name on the assessment. The assessment revealed exceptions to the peri area, under breast, bilateral, scaling feet and back, and redness and scaling. The location of the redness and scaling was not documented. Review of the skin assessment located in the EMR nurse’s flowsheet dated 02/05/25 at 11:45 AM revealed bilateral buttock redness. -On 02/06/25, nurse documented redness on the sacrum. -On 02/08/25 at 9:20 AM, a sacral wound was mentioned in the nursing flowchart notes. No photographs were taken. -On 02/13/25, P1 was discharged to the facility’s rehabilitation hospital under the same federal certification. A two-nurse head-to-toe skin assessment, located in the EMR nurse’s flowsheet, was documented on 02/13/25 at 6:21 PM, which revealed P1 had redness to the groin, peri area, and breakdown on the sacrum. Review of the nursing notes, dated 02/13/25 at 8:22 PM and located in the EMR nurse’s flowsheet, revealed rash, redness, and an unstageable pressure injury to the sacrum. During an interview on 07/29/25 at 3:58 PM, NM3 stated opportunities were missed by nursing staff to properly document and stage P1’s sacral injury. NM3 stated the nurses who first observed and documented P1’s pressure injury on 02/13/25 should have requested a nurse-to-nurse wound consult for proper staging and notified the physician. During an interview and record review with the Certified Wound Ostomy Nurse (WOCN) 1, she confirmed the record revealed that P1 was admitted on 02/13/25 at 1733 (5:33 PM) to the rehab hospital with a small pressure injury to the coccyx area. WOCN1 stated the pressure injury started at the surgical specialty unit, but no photograph was taken of the area in the surgical specialty unit. P2. During chart review with WOCN1 on 07/30/25 at 9:55 AM, she stated P2’s initial wound picture taken on 11/12/24 at 2:14 AM on admission to the CVICU (cardiovascular intensive care unit) revealed there was a pressure injury present on admission and that this was not a hospital acquired pressure injury. WOCN1 stated there was some darkening over the sacral coccygeal area, indicating the beginning of a DTI (deep tissue injury). WOCN1 stated the picture was taken by the Assistant Nurse Manager (ANM) 1 of the CVICU. When asked if ANM1 had identified the DTI at the time of admission, WOCN1 stated, it was neither identified nor documented as a DTI. WOCN1 stated it was documented as a redness to the sacrum. After reviewing P2’s sacral picture taken on 11/27/24, WOCN1 stated an area of the sacrum that was previously dark revealed the top layer epidermis was coming off which was how a DTI evolved. WOCN1 stated the wound was evolving to a stage two pressure injury. WOCN1 stated once the DTI was there; the skin was going to break down. WOCN1 stated the worsening of the skin breakdown was the evolution of the original DTI, and that it was inevitable for the epidermal tissue to come off. After reviewing P2’s sacral photograph, dated 12/05/24, WOCN2 stated the sacral pressure injury revealed further breakdown and that the wound had now become unstageable. WOCN1 stated P2 was discharged on 12/09/24 and was no longer seen by the wound care nurse. When asked when the unit nurses should have consulted wound care, WOCN2 stated, they should have consulted wound care as soon as they saw the darkened area of the sacrum and documented the skin exception. WOCN2 stated the unit nurses should have consulted as soon as they saw any kind of skin discoloration, which was a missed opportunity. During an interview on 07/31/25 at 12:10 PM, the SSP stated P2 underwent a CABG (Coronary Artery Bypass Grafting - a surgery to improve blood flow to the heart muscle) that lasted from 1:15 PM through 7:15 PM (6 hours). SSP (Senior Safety Partner) stated P2 was transferred to the CVICU. When asked if a head-to-toe skin assessment was performed by two nurses on admission to the CVICU, the SSP stated, there should have been. When asked if any internal investigations were conducted and any action plans were implemented for P2’s unstageable pressure injury, the SSP stated those were done only for hospital acquired pressure injuries, and P2’s sacral injury was not considered to be a hospital acquired pressure injury. During an interview on 07/31/25 at 12:16 PM, the SSP stated there were no action plans or corrective action plans implemented for P2 because the sacral injury reported to the state agency on 04/09/25 was later determined to have been present on admission and was therefore not considered to be a hospital acquired pressure injury (HAPI). SSP stated P2 was admitted 11/11/24, and on 12/05/24 wound care validated an unstageable pressure injury to the coccyx. SSP stated on 11/27/24, the wound ostomy nurse got a nurse-to-nurse consultation for the validation of a pressure injury. SSP stated the wound nurse saw P2 on the same day and validated that there was an unstageable pressure injury to the coccyx. SSP stated there was a wound care photograph taken on admission on 11/11/24. SSP stated no pressure injury was documented as identified on admission. SSP stated the wound note documented that P2’s admission photograph was taken after a very long surgery day and appeared to show breakdown beginning on the sacral coccygeal area. P3. During an interview and medical record review on 07/29/25 at 1:23 PM the Unit Manager of CVU (cardiovascular unit monitored surgery 4D), (NM) 4 stated P3 was admitted to the facility from home on 02/28/25. NM4 stated a hospital acquired pressure injury (HAPI) was discovered on 03/12/25, and P3 was seen by the wound nurse on 03/22/25. NM4 stated P3 was in the Cardiovascular Intensive Care Unit from 02/08/25 through 03/07/25. NM4 stated P3’s case was misleading because he moved independently and was continent of bowel and bladder. NM4 stated P3 had a history of bipolar disorder but was not aggressive in his interactions with staff. NM4 stated P3 was an unlikely candidate to develop a pressure injury. NM4 stated however, when P3 slept, he slept like a rock and could be still for hours and not move while he slept. NM4 stated P3 was educated by nursing on his need to move and was independent in his mobility. NM4 stated it was surprising that he developed a pressure ulcer. NM4 stated P3 was diabetic. NM4 further stated that P3 was swollen, and fluffy with fluids. NM4 stated an initial skin assessment was performed by two nurses on 02/28/25 at 2:30 PM. NM4 stated that no pressure injury was documented. NM4 stated that another skin assessment on 03/7/25 at 9:30 PM revealed no pressure injuries. Review of the Braden score, dated 03/12/24 and located in the EMR nurse’s flowsheet, revealed 18, indicating P3 was at risk for skin breakdown. Review of an EMR photograph of P3’s sacrum taken on 03/12/24 at 6:08 PM and placed in the medical record revealed there was no accompanying note to describe the status of the skin. During an interview on 07/29/25 at 1:40 PM, NM4 stated that the nurse may have thought the picture was enough to document the status of P3’s skin. NM4 stated the nurse staged the sacral pressure injury at stage two. When asked what nursing interventions were implemented from 03/12/25 to 03/22/25 when a wound care consult was entered, NM4 stated there were nurse-driven interventions and that “in our practice nurses should be able to care for stage one and stage two pressure injuries. Anything beyond stage one and stage two, we consult the wound care nurse. It is basic nursing care.” NM4 stated when the facility reviewed the case, two-hour turns were not being consistently documented. NM4 stated P3’s Braden score was mostly over 18 and he was walking around independently, which made him low risk for pressure injury. During an interview and medical record review with WOCN1 on 07/30/25 at 1:23 PM, she stated she thought P3’s wound was deemed unstageable, she would have staged it as stage two. WOCN1 confirmed that P3 had no skin breakdown on admission and developed the sacral skin breakdown while in the facility. WOCN1 stated the unit nurses should have consulted the wound care nurse sooner than they did. P3 was discharged four days after he was seen by the wound care nurse and went home with home health. P4. Review of P4’s medical record with the surgical trauma intensive care unit manager (STICU), (NM 2) on 07/29/25 at 11:33 AM, revealed P4 presented to the facility’s ED (emergency department) on 11/04/24 at 8:20 PM with complaints of abdominal pain with nausea and vomiting, and admitted on 11/4/24 at 8:52 PM. NM2 stated P4 was transferred to the preoperative area on 11/04/24 at 11:03 PM and went to the operating room (OR) on 11/05/24 At 12:09 AM. NM2 stated P4 was admitted to the STICU on 11/05/24 at 8:07 PM. Review of the admission skin assessment, performed by two Registered Nurses (RNs) on P4 in the STICU, dated 11/05/24 and located in the EMR nurse’s flowsheet, revealed a Braden score of 15, indicating a high risk for developing a pressure injury. The admission skin assessment documentation revealed no skin breakdown or pressure injury. Review of the wound care nurses notes and images of P4’s sacral and buttock areas with pressure injuries revealed: “...Wound 11/08/24 Pressure Injury Coccyx...Date First Assessed: 11/08/24 Time First Assessed: 1800 [6:00 PM]. Present on Original Admission: No. Primary Wound Type: Pressure Injury, present on arrival from ICU - previously charted as blister but now stage 2 Wound. Location: Coccyx Wound Orientation...” Flow sheet nursing documentation, located in the EMR nurse’s flow sheet, revealed as follows: -11/08/24 popped blister but area not open. -11/08/24 1944 (7:44 PM) buttock blister. -11/09/24 foam border dressing on the blister. -11/10/24 0800 (8:00 AM) popped blister. -11/11/24 Patient transferred to the cardiovascular (CV) monitored surgery (stage 2 clean, open, red). -11/12/24 wound bed description- red. -11/12/24 1930 (7:30 PM) wound bed clean, open, red. -11/1324 0850 (8:50 AM) clean, open, red. -11/14/24 0920 (9:20 AM) clean, open, red. -11/15/24 1029 (10:29 AM) clean, fragile, pink. -11/16/24 2129 (9:29 PM) clean, dry, painful, pink. -11/17/24 1615 (4:15 PM) painful, dry. -11/18/24 0730 (7:30 AM) open, painful. -11/23/24 fragile open, pink, red. -11/24/24 0800 (8:00 AM) fragile. -11/25/24 fragile, open. During an interview on 07/29/25 at 12:01 PM NM2 confirmed that none of the nurses entered a nurse-to-nurse wound care consult for P4 after documenting his sacral wound. Review of a wound care consult ordered by the physician on 11/23/24 at 7:59 AM and located under the “Consults” section of the EMR, revealed: “Wound Ostomy Provider Consult: Eval and Treat ordered by MD [Medical Doctor] at 11/23/24 0759.” Review of the wound care nurse’s notes, dated 11/25/24 at 11:45 AM and located under the “Consults” section of the EMR, revealed: “ ... RN WOCN Reason for consult ‘Needs treatment.’ Stage three over the coccyx and extends to the right buttock.... Wound 11/08/24 Pressure Injury Coccyx...Date First Assessed: 11/08/24 Time First Assessed: 1800. Present on Original Admission: No. Primary Wound Type: Pressure Injury, present on arrival from ICU - previously charted as blister but now stage 2 Wound. Location: Coccyx Wound Orientation...Consult Method: Eval and Treat Order ...Patient with stage 3 pressure injury over coccyx that extends to right buttock. Wound Bed Description: Fragile; Moist; Painful; Pink; Red; Slough; Yellow Primary Etiology Pressure Injury Pressure Injury Stage 3...” During an interview on 07/29/25 at 12:57 PM, NM2 admitted that ideally, her expectation would have been that unit nurses did a nurse-to-nurse consultation with the wound care nurse when P4’s sacral wound progressed and became “painful.” NM2 stated a photograph was taken of P4’s sacral area, but staff failed to identify and document a DTI that they now believed was present on the right lateral coccyx on admission. NM2 stated there was a purplish discoloration on the right buttock. When asked why there was no mention of a DTI in the wound care nurse’s notes, NM2 stated it was present in the admission pictures. When asked what impact a possible DTI had on P4 developing a stage three sacral injury, she stated “that was where it first showed up on that right buttock.” When asked why it was difficult to identify the DTI on admission, NM2 stated it was difficult to identify darkly pigmented skin. When asked how the discoloration on the buttock migrated to the sacrum, NM2 had no response. During an interview on 07/30/25 at 10:36 AM the WOCN1 stated P4’s pressure injury was present on admission per the admission photograph. During a review of the admission photograph, WOCN1 stated it looked like there was a dark area over the bony prominence of the sacrum indicative of a DTI. When asked which skin breakdown was present on admission, the sacral pressure ulcer, or the buttock blister, WOCN1 stated there could also be a DTI on the buttock but she could not tell due to the shadow in the photograph of the wound. When asked if the DTIs in the sacral and buttock areas were identified on admission, WOCN1 stated it was not documented that there was a DTI present on admission. WOCN1 stated no wound care consult was entered for P4 but was seen by the wound care nurse on 11/14/24 during an NDNQI (National Database of Nursing Quality Indicators) prevalence study. Review of the wound care nurse’s (WOCN) 2 note, dated 11/14/24 at 12:37 PM and located under the “Consults” section of the EMR, revealed: “This RN was asked to see the patient for NDNQI confirmation of staging. On assessment, patient has stage 2 to the right buttock. Recommend Barrier cream BID [twice day] for protection from incontinence. Call with questions or concerns.” During continued interview on 07/30/25 at 10:36 AM, when asked why the wound care nurse only documented stage two to the buttock, WOCN1 stated the sacrum had not started to break down yet. When reminded that she had already alleged there was a DTI present on admission and the wound care nurse had already established a pressure ulcer to the coccyx, WOCN1 stated the WOCN2 must have missed P4’s coccyx wound on 11/14/24. During an interview on 07/31/25 at 11:58 AM the SSP stated P4 was admitted to the facility on 11/05/24. SSP stated on 11/14/24, wound care validated a stage two pressure injury to the coccyx. SSP stated on 11/25/24 the stage two pressure injury had progressed to a stage three pressure injury. SSP stated no investigation was conducted because it was determined that a photograph was taken within 24 hours of admission and that a DTI was already present on admission and progressed. SSP admitted there was no documentation in the medical record that a DTI was present on admission. SSP stated he did not know why the DTI was undiscovered on admission. SSP stated P4’s sacral pressure injury was discussed in a Hospital Acquired Pressure Injury (HAPI) debrief and it was decided that there would be no Root Cause Analysis (RCA) done. When asked if the facility was able to determine the cause of nursing staff failing to detect DTI on admission and deteriorating into stage three pressure injury, SSP stated he did not know and that the facility should have conducted an RCA all the same.”

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 28883 Based on record review, review of the hospital’s Quality Assessment Performance Improvement (QAPI) Program, and interview, the hospital’s Quality program staff failed to timely implement interventions to prevent recurrence for an adverse event in which a nurse administered an incorrect emergency medication during a Rapid Response to 1 of 20 patients reviewed. The hospital’s pharmacy services had implemented a change in the medications contained within the crash cart that contributed to the medication error. The findings included: Cross Refer to A-286 Patient Safety”

“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: 28883 Based on record review, review of the hospital’s Quality Assessment Performance Improvement (QAPI) Program, review nurse education, and interviews, the hospital’s Quality program staff failed to timely implement interventions to prevent recurrence for an adverse event in which a nurse administered an incorrect emergency medication during a Rapid Response to 1 of 20 patients reviewed. The hospital’s pharmacy services had implemented a standardization change to the medications contained within the crash cart that contributed to the medication error. There was nothing in place to ensure nurses had read and understood the notification sent out by pharmacy on the initial change in the code cart emergency medications, nor had the education to prevent recurrence of the medication error been provided to the Rapid Response Nurses/Intensive Care Unit Nurses by the time of survey exit. The hospital was unaware of how many code cart trays had been changed out to include the labeled (light protected) bag of Epinephrine. Interview with the Director of Quality and Rapid Response Team Nurse Manager (who were involved in the development of the corrective action education for nursing staff) revealed an incomplete understanding of the changes to the code cart medication trays made by pharmacy services. They were not able to identify the way the new code cart medication trays were supposed to look or identify what change(s) had been made to the trays as a corrective action. The findings included: Cross Refer to Tag A-392 - Staffing and Delivery of Care Review of Patient #1’s medical record on 5/5/25 at 2:45 PM revealed the patient had been administered the medication Adrenaline/Epinephrine during a critical medical event instead of the ordered medication Adenosine. During a phone interview on 5/6/25 at 4:55 PM, Rapid Response Registered Nurse #1 stated, “The physician had given a verbal order for adenosine, I saw [the letters] “ad”on the vial, pulled up the med, and administered it. The patient converted out of SVT [Supraventricular Tachycardia] to ST [sinus tachycardia], his/her BP [blood pressure] was up. S/he developed chest pain and non-sustained v-tach [ventricular tachycardia] which was transient. My partner asked and said “Did you see the vial? Was this administered?” I told the provider adrenaline was administered and not adenosine.” When asked what s/he thought had happened, Rapid Response RN #1 stated that when s/he went to the crash cart, “It looked different than it used to; never had adrenaline [vials] in there before. Adenosine was the only medication that started with [the letters] ad; that I knew. When I went to pull the medication, I had not realized there was different medication there.” On 5/6/22 at 9:22 AM, the Director of Quality pulled out her/his computer to review 4 pictures attached to the hospital’s Root Cause Analysis (RCA) of the event for Patient #1; and stated they were changing the code cart medication tray layout as a result of the incident. A picture was shown and the Director of Quality stated, “This is how it (code cart medication tray) is supposed to look now.” The picture was of Epinephrine (Epi), 30 ml (milliliter) vial in a box, with adenosine in vials on the right. There were also 2 pictures shown of adenosine vials with a beige cap, and adrenaline vials with a purple top. The Director of Quality tried to assure the surveyor that for one of the pictures, in which the medication name on the vial was blurry, the purple top vials were adenosine when it was adrenaline. According to the Rapid Response Team Nurse Manager, these medication vials had previously been stored next to each other on the right side of the tray. Both the Director of Quality and the Rapid Response Team Nurse Manager were unsure of why the pictures containing the vials of medication had been attached or where they had come from. The Director of Quality had stated that s/he did not attend the RCA meeting for Patient #1 as s/he was not working that day. The Pharmacy Supervisor came in shortly after the start of the pictures (at about 9:42 AM) and the surveyor requested that these pictures be reviewed again with the Pharmacy Supervisor present and verification done as to what they were. The Pharmacy Supervisor reviewed the pictures with the surveyor. Picture 1 1061- bag of adenosine with beige tops, 3 mg/1 ml, and vials of adrenaline with purple caps on top of page. Picture 2- 1059 was bag of adrenaline 1mg/ml on the left, adenosine vials in bag on the right. Picture 3 1060, that is the adult only crash cart, the old way, old crash cart with adrenaline. Picture 4- (not numbered) adult code tray with epinephrine, 30 ml vial. This tray had been identified by the Director of Quality as the new setup for the code cart medication trays. According to the Pharmacy Supervisor, “This adult code tray is not a tray we use here at this hospital. We never stocked the epi 30 ml vials here.” The surveyor verified this information again with the Pharmacy Supervisor who stated it was a box containing the epi 30 ml vial that they “didn’t and don’t use here in this hospital.” The four pictures attached to the RCA did not contain the new tray layout proposed as a result of the medication error for Patient #1. The Pharmacy Supervisor was asked and stated s/he was not aware how many emergency medication trays on the crash carts had been changed out. As the staff use the tray, they bring them back and they are changed out to the new trays. They are moving to label the adrenaline vials in a light protected bag, with the light protected bag labeled epinephrine. They are using an adult/pediatric code cart on floors that have both adults and children; with 5 vials of epinephrine and vials of adenosine in baggies. Adenosine vials are stored on the right side of the tray in the same place they have been stored in the past. According to the pharmacist, Epinephrine/Adrenaline vials had not previously been included on the code cart prior to February 2025. At that time the vials were added for system standardization of the code carts. When asked what had changed as a result of the medication error for Patient #1, the Pharmacy Supervisor stated they (pharmacy) started labeling the outside of the bag of adrenaline vials, “Epinephrine”, and put the medication in a light protected bag. Nothing had changed related to the placement/location (of the Epinephrine or Adenosine vials) on the code cart tray. The change would take effect starting 4/23/25 as the trays came back to the pharmacy. S/he was not sure about how many had been completed (trays changed out). The Pharmacy Supervisor stated that initial education had been sent to nursing staff to inform them that change was coming to standardize the code cart medication trays and this went live in Epic (electronic record system) on February 4th, 2025. (This education was entitled Code Cart Updates, Upstate) Observation was completed on 5/6/25 at 10:07 AM with the Rapid Response Team Nurse Manager of the unit 2D crash cart, the unit Patient #1 had been located at the time of his/her Rapid Response. The vials of adrenaline with purple tops were observed in a regular clear bag and had not been labeled. The vials were not in a light protected bag and the baggie did not contain the label “Epinephrine”. The Rapid Response Nurse Manager verified this cart had not been changed over to the light protective bag labeled “Epinephrine”. An interview was conducted with the Rapid Response Team Nurse Manager on 5/6/25 at 11:53 AM- who stated a “Read and sign” education would be provided for the RRT (Rapid Response Team) nurses and ICU (Intensive Care Unit) code responders. The education would be to provide nursing staff that respond to codes or rapids, an awareness of the configuration of the code cart prior to a critical situation; and to impress on the nurses that closed loop communication with a Provider or other nurses (re: medication verification) is essential to providing ongoing safe patient care. Review of the education “Read & Sign for RRT & ICU code responders” revealed “Situation- Code cart medication drawers have gone through a revision and pharmacy is working to replace the old set up but education needs on the updates have been identified. Background- During critical situations (RRT or code) when code carts are utilized, team members are not as familiar with the new layout/product changes. Awareness of the configuration of the cart prior to a critical situation and closed loop communication with provider/other RNs is essential to providing ongoing safe patient care. Assessment- In a recent patient safety event, it was identified that product changes and need for additional education is desired for all RRT and ICU code responders. Response- Expectations: Prior to a critical event, responders need to look at what the prior code cart medication drawer looks like in comparison to the new code cart medication drawer. Review of comparison pictures that had been attached to this Rapid Response Team “Read and Sign for RRT & ICU code responders” education revealed the incorrect picture had been attached to show the nurses the layout for the new medication drawer. According to the RRT Nurse Manager, the due date to have this training completed is the beginning of June 2025. The expectation is that the nurses are to sign a roster and turn the roster in. When asked if there was any way to determine who had already received the training or if anyone had signed that they had received training, the Rapid Response Team Nurse Manager stated there was no way to determine this. According to the RRT Nurse Manager, the RRT nurses have a meeting next Wednesday where they are going to provide the education; “Hit them all at once,” and get them to sign. According to the RRT Nurse Manager, they are going to a 2-person verification of the right medication and dose, with a verbal closed loop communication being required. Another nurse or physician should verify the right medication, the right dose. Verbal closed communication means (read out the medication. For example, I’m giving one of epi and the person should say yes, 1 of epi). This is 2-person verification and closed loop. Close of loop verbally is to respond back. To fulfill the 5 rights of medication administration. The RRT Nurse Manager stated, “I included the old and new med tray” pictures in the education. The Nurse Manager and surveyor reviewed the pictures and the surveyor informed the Nurse Manager that this was not the correct picture of the new layout of the tray as it did not have the adrenaline vials in a light protected bag labeled “Epinephrine”. The RRT Nurse Manager stated s/he will change it and update the picture to the correct one. S/he had videotaped education on the new process (of 2-person verification and closing the loop) and nursing education for the RRT on 5/1/25 and included power point slides with the pictures of the code cart emergency medication trays (s/he stated s/he is going to update these to the correct picture). An interview was conducted on 5/7/25 at 8:00 AM via Teams video with the Director of Clinical Pharmacy Services and the Medication Regulatory Compliance Pharmacist. Present in person for the interview was the hospital’s Medication Safety Officer and the Pharmacy Supervisor. The Director of Clinical Pharmacy Services stated that they had taken on the project to standardize all of the Prisma hospitals’ code cart trays because they had a big variety of medications within the code carts throughout the system. Their Upstate facilities had different things/medications in their trays. The initial spur to change was from an inventory standpoint. A lot of the medications stored in the code carts was not required by ACLS protocol and medications were expiring that had not been needed. They wanted to standardize. It was taken to the PMT (Pharmacy and Therapeutics) Committee for approval. They approved it. The Pharmacy Supervisor stated, “Currently our process for getting the medications changed out is that once the code cart medication tray is used in code or emergency situation, the nursing staff bring them back (used tray), and the pharmacy staff will exchange it with a new tray.” When asked what had changed in February as a result of the effort to standardize; it was stated that they had added Epinephrine vials to the tray in order to make an Epinephrine drip. Pharmacy services also added norepinephrine vials in order to make the norepinephrine drip. They changed the quantity of epinephrine and sodium bicarbonate abbojects to increase the number. The Director of Clinical Pharmacy Services stated the standardization rollout started in February 2025 with the clinical education team to inform the nurses of the new trays. The Medication Safety Officer stated that “One of the things we talked about [in response to the medication error for Patient #1], was to make it clearer to nursing. Nothing changed related to the content and layout of the trays [since February], but we are adding the label to the bag of Adrenaline/Epinephrine. We are only changing the labeling of the bags of epinephrine. The light protected bag has nothing to do with the incident.” On 5/7/25 at 8:31 AM, during the Teams interview with pharmacy staff, the Director of Quality was observed asking the pharmacist present which pictures were ‘for them’ with the old and now correct layout of the medication code cart trays. In response, a pharmacist present sent the Director of Quality a picture of how the new code cart tray should look. An interview was conducted on 5/7/25 at 9:15 AM with Rapid Response RN #5, who was present during part of the Rapid Response for Patient #1. Rapid Response RN #5 stated s/he wasn’t sure what had happened initially with the medication error. “Rapid Response RN#1 took me out of the room and said there had been a mix-up, that Hospitalist Physician #1 was aware.” Rapid Response RN #5 stated that the code cart medication tray had changed; but s/he was not sure about when/the date. When asked how s/he found out about the changes, the nurse stated that s/he had been in the middle of a code (this was some time after the Rapid Response for Patient #1), opened the code cart, and there were additional medicines that had not been stored in the code cart previously. The nurse stated, “I know there was levophed and different concentrations of epinephrine (that had not been there previously).” The medication tray was set up a little differently. When asked what other things may have changed, the nurse stated; “This was in the middle of code, I didn’t take time to look but I did notice. I noticed during the code.” When asked if anyone had told her/him about the changes to the medication trays prior to the code, s/he stated that during the debriefing for Patient #1 on 4/14/25, s/he had been informed of changes; but not after 4/14/25. The nurse stated the addition of Levophed to the code cart tray had occurred after 4/14/25. Rapid Response RN #5 stated that Rapid Response RN #1 had spoken to her/him on 4/14/25 after the incident with Patient #1, and was upset. Everyone present for the Rapid Response for Patient #1 and management staff held a debriefing 4/14/25, shortly after the incident. Discussed was the why, the changes in the crash cart layout, how we can make improvements and educate. I had been aware there were changes to the tray layout because of the incident with Patient #1, but there had been additional changes made to the tray layout at another code after the incident with Patient #1. I was situationally aware at that time. We had no education of the changes prior. There is education coming “that’s in the works”. During an interview on 5/7/25 at 1:53 PM, the Patient Safety Partner who led the RCA for Patient #1 stated that factors that contributed to the medication error for Patient #1 included that the nurse did not read the medication being administered. “S/he read (the letters) “ad” and picked up the medication”. The Patient Safety Partner stated that though it may not be significant, the education on the standardization of code trays was not enough. It was not a huge change - they added medications. When asked what education was provided to the nursing staff related to the standardization of the code trays; the Patient Safety Partner stated an alert went out to nurses on an education update, which was an e-mail that contained a link to the hospital’s education site. The education was a notice that the pharmacy was standardizing the code medication trays. “I took a screen shot of that during the RCA”. Review of the information provided to the nurses from the education site was reviewed and was titled “Code Cart Updates (Upstate)”, and stated “There is currently variability in the configuration of medication trays within code carts across the system, including differences in the type and quantities of medications, as well as the number of trays provided. Additionally, a safety initiative has been implemented to eliminate the use of multidose vials (e.g. epinephrine) to reduce the risk of inadvertent compounding errors at the bedside. All adult and peds trays will be updated as medications expire and are restocked”. The information did not include what medications had been added to the code cart medication trays as a result of the standardization. According to the Rapid Response Team Nurse Manager, everybody at the hospital that is clinical will get the alert if it is related to their discipline. When asked if there was anything else that may have been a contributing factor for the medication error, the RRT Nurse Manager stated that Rapid Response Team nurses are on a rotation, and it is possible they may not have been involved in a Rapid Response for several weeks. “The last time they were here, they saw the old version of the medication layout in the code cart trays; and then they come back and there is the newer version.” When asked if there was any way to know which nursing staff, if any; had read the information on the “Code Cart Update”; the Director of Quality stated there was no way to know which staff had read it. When asked what root causes they identified in the event for Patient #1, the Patient Safety Partner stated, that the medication process was not followed, and that the standardization of the code cart medication trays are in progress and not complete. When asked what had been decided on the corrective action, the Rapid Response Team Nurse Manager stated that all RRTs would read sign the education, to acknowledge the training and show that there were no additional questions. According to the RRT Nurse Manager, in critical situations (Rapid Responses and Codes) where medication administration is being captured in the Narrator and not the MAR (Medication Administration Record), a 2-person verification AND verbal closed loop communication is required to fulfill the 5 rights of medication administration. The Nurse Manager stated this training is in progress and due by June 1, 2025. When asked if they had any progress on the training yet, the Nurse Manager stated that Neuro ICU and Trauma ICU are working on it. CV and ICU staff are meeting next week and those not attending will have to get the training individually. RRT training will be done by 5/13/25. The same education is going to Critical Care Nursing Specialty Operations (NSO) Committee meeting (corporate) of which s/he is the Vice Chair, to share what had been learned through this event. According to the Patient Safety Partner, the action for pharmacy was to label any bundled smaller medication vials instead of having them in a clear ziplock bag. The strong action of standardization of drug trays system wide has been completed. The measure of success is a pharmacy audit to ensure 100% standardization. This audit has not been completed yet. The Patient Safety Partner started to say that during the RCA, they had identified that the ACLS protocol standard was for a 2- person closed loop verbal confirmation for medication verification, and this had not been done. The RRT Nurse Manager responded stating that this was encouraged during ACLS training, but it was not in the hospital policy to do that. When asked why delay the education for the nurses, the RRT Nurse Manager stated that they wanted to make sure they had everything correct before trying to educate the staff. S/he gave the example that they now need to edit the picture in the education training because it didn’t have the light protected bag of Epinephrine labeled. They wanted to make sure what they were telling the nurses was the right thing. They didn’t want the cart before the horse and have to pull it back. When asked who helped develop the nurse education, the RRT Nurse Manager stated this was information obtained from the RCA review, and the Director of the Rapid Response Team/Director of Critical Care felt like it was a good requirement. The RRT Nurse Manager stated that s/he would like a verbal dual verification, for all medications that the nurses are giving during a rapid response (not just the High Alert medications outlined in policy). S/he has to take that recommendation to the NSO Committee. A lot of the hospital policies are more standardized. The flight nurses and others do a verbal confirmation to close the loop. This was not an expectation prior (to the event with Patient #1). That is now the expectation, to close the loop verbally. When asked why the pharmacy services had not changed out all the code cart medication trays immediately instead of waiting until they expire or are used; the Director of Quality was unsure of the reason.”

“STAFFING AND DELIVERY OF CARE CFR(s): 482.23(b) The nursing service must have adequate numbers of licensed registered nurses, licensed practical (vocational) nurses, and other personnel to provide nursing care to all patients as needed. There must be supervisory and staff personnel for each department or nursing unit to ensure, when needed, the immediate availability of a registered nurse for care of any patient. This Standard is not met as evidenced by: 28883 Based on record review, interviews, and review of the policy “General Medication Administration: Prisma Health”, Rapid Response Registered Nurse (RN) #1, one of fourteen Rapid Response nurses employed by the hospital, failed to ensure the correct ordered medication (Adenosine), had been administered for Patient #1 (1 of 20 patients reviewed for Rapid Response) who was in Supraventricular Tachycardia. The nurse administered the medication Epinephrine instead. The findings included: Review of Patient #1’s medical record on 5/5/25 at 2:45 PM revealed the 71 year-old and had been admitted on 4/11/25 with Hyponatremia and a Small Bowel Obstruction. S/he had been discharged home on 4/18/25. The record included the following: A progress note by Hospitalist Physician #1 dated 4/14/25 at 9:07 AM documented that s/he had been called to the bedside of Patient #1 by nursing staff because of an elevated heart rate. Patient states s/he feels a little dizzy but otherwise denies chest pain or sob (shortness of breath). BP (Blood Pressure) has been low normal during this hospital stay but bp acutely lower than baseline in the high 70’s systolic. ECG (electrocardiograph) showing concern for SVT (Supraventricular Tachycardia) (abnormal heart rhythm), rapid response called. Fluid bolus ordered and started. Patient’s BP was cycled multiple times (BP machine tried to take BP several times in a row), placed on leads to the crash cart. Leads confirmed persistent SVT, BP remained low however patient appeared stable. Decided to proceed with adenosine 6 mg (milligrams). Patient was given 1 mg epinephrine in error which was not discovered until after medication was administered. After epinephrine was given patient had 2 short runs on the monitor of monomorphic V-tach (Ventricular Tachycardia). Patient developed symptoms of worsening lightheadedness, shortness of breath, and substernal chest pain. After the episodes of monomorphic Vtach ended, patient’s heart rate did decrease. Heart rate normalized into Sinus Tachycardia in the 120’s. BP initially was elevated and then once again lowered. Patient’s chest pain resolved within 2 minutes of epinephrine administration. Repeat EKG showed concerns for ST elevations in anterior leads with reciprocal depression. Cardiology involved. A Cardiology Service progress note dated 4/14/25 at 10:25 AM documented; “consulted for inferior-posterior STEMI (ST Elevated Myocardial Infarction) and V-tach in s/o (significance of) receiving epinephrine rather than adenosine for management of SVT. Patient was in SVT and plan was for adenosine, however [s/he] received epinephrine and subsequently went into VT before converting back to sinus rhythm. At baseline prior to this admission [s/he] states that s/he has intermittent palpitations but was able to walk around a grocery store and stay active without symptoms to suggest angina. TTE [Transthoracic Echocardiogram] with severely reduced EF [Ejection Fraction] 20-25% and apical akinesis. [Information from an internet search of the American Heart Association revealed an ejection fraction measures the amount of blood pumped out by the left ventricle with each contraction. A healthy person would have an EF of 50%-70%.] Would not pursue ischemic evaluation at this time given that [his/her] troponin elevation and transient ischemic EKG changes were related to epi [epinephrine] administration. Suspect stress induced cardiomyopathy from epi administration earlier today. This morning pt developed tachycardia/palpitations. [S/he] was noted to be in a supraventricular tachycardia. Rapid response was called. Adenosine was ordered but patient inadvertently received epinephrine instead. Pt developed salvos of V-tach and chest discomfort before ultimately spontaneously converting back to normal sinus rhythm. ECG immediately following the event showed inferior posterior ST segment changes consistent with possible STEMI. Fortunately, repeat EKG 15 minute later showed these changes were resolving. Patient’s chest pain resolved as well.” A Cardiology note dated 4/17/25 at 9:41 AM revealed; “Off levaphed drip. No CV [cardiovascular] symptoms. Telemetry with no arrhythmia, NSR [normal sinus rhythm] 80-90s, repeat limited echo personally reviewed this am with normalized LVEF [left ventricle ejection fraction] and small pericardial effusion adjacent to RV [right ventricle] that is not hemodynamically significant by echo. Will sign off and arrange outpatient GDMT [Guideline directed medical therapy].” Review of Rapid Response nursing documentation on 5/5/25 at 3:52 PM with the Rapid Response Team (RRT) Nurse Manager revealed documentation that on 4/14/25 at 9:03 AM, Epinephrine 1 mg /ml was given by Rapid Response Registered Nurse (RN) #1. An interview was conducted with Hospitalist Physician #1 on 5/6/25 at 12:00 Noon. “The nurse called me about [his/he]r elevated heart rate. The patient was just dizzy, not feeling horribly. Hooked [him/her] up to leads on crash cart and looked to be in SVT. Gave 1 liter of fluids, called a rapid. Did an EKG before giving medications and confirmed what we were seeing. With the patient being hypotensive I asked to give adenosine. We assumed it was given, and I told Patient #1 [s/he] would feel horrible, but there was no pause like expected. [S/he] had 2 runs of v-tach, and had chest tightness. If adenosine is administered, there is an intentional cardiac pause that resets your heart. It will cause a short pause, with hopefully a re-initiation of normal sinus rhythm or sinus tachycardia. Patient #1 had v-tach which was not expected. The patient’s BP went up, but with short runs (V-tach) (all within a minute) [his/her] heart rate did come down which you could see with adenosine, typically in the 120s. And then Patient #1 said [s/h]e felt better in a minute and a half period, then [heart rate] back up in the 160’s to 170s, and [s/he] looked and felt better. That was about the time the rapid response nurse noticed what happened. [S/he] showed me what [s/he] had given. That made me more concerned about the patient’s complaint of chest tightness and explained why there had been no pause and the V-tach. The picture was much clearer. The rapid nurse was distraught. [Her/hi]s story was that the medications had been redistributed without [her/his] knowledge, meaning to grab the adenosine (the epi was now there). I had said, “Let’s give 6 mg adenosine”. This was the communication to the 2 rapid nurses.” A phone interview was conducted on 5/6/25 at 4:55 PM with both Rapid Response Nurse #1 and the Director of the Rapid Response Team. Rapid Response RN #1 stated s/he “had responded to Patient #1 due to a rapid because the patient was in SVT. The physician had done an EKG and gave a verbal order for adenosine, I saw [the letters] “ad”on the vial, pulled up the med, and administered it. The patient converted out of SVT to ST [sinus tachycardia], [his/her] BP was up, developed chest pain and non-sustained v-tach which was transient. My partner asked and said “Did you see the vial? Was this administered?” I told the provider adrenaline was administered and not adenosine. I reported what happened and the provider reported.” When asked what s/he thought had happened, Rapid Response RN #1 stated that when s/he went to the crash cart it looked different than it used to, “never had adrenaline in there before. Adenosine was the only medication that started with [the letters] ad; that I knew. When I went to pull the medication, I had not realized there was different medication there. I read the first two letters [on the vial].” Review of the policy “General Medication Administration: Prisma Health”, reviewed 8/3/25, revealed information that prior to administration, the individual administering the medication does the following: Verifies that the medication selected matches the medication order and product label with respect to the medication name, strength, dose, and dosage form.”