Summa Health System

“RESPIRATORY CARE SERVICES POLICIES CFR(s): 482.57(b) Services must be delivered in accordance with medical staff directives. This Standard is not met as evidenced by: 44810 Based on interview, record review, and review of facility policies, the facility failed to ensure endotracheal tube (ETT) twill ties were changed every shift per policy resulting in a necrotic upper lip pressure injury. This affected one (Patient #4) of three patients reviewed for ETT tubes. The facility census was 863. Findings include: Review of the medical record for Patient #4 revealed she was admitted to the hospital on 02/10/25 and discharged on 03/25/25. Patient #4 was admitted to the hospital after suffering a fall at home and becoming unresponsive for a moment. Patient #4 had a past medical history of recurrent pancreatitis, insulin dependent diabetes, alcoholic hepatic steatosis, and tobacco use. Patient #4 was diagnosed with diabetic ketoacidosis, lactic acidosis, severe sepsis related to a urinary tract infection, alcohol use disorder, polysubstance abuse, and hepatic steatosis. Initial skin assessment dated 02/10/25 at 4:00 P.M. revealed Patient #4 had no open areas and was rated at high risk for developing pressure ulcers. Patient #4 had to be intubated on 02/11/25 due to encephalopathy and she had an endotracheal tube (ETT) placed. Review of the respiratory documentation revealed her ETT tube ties were not changed until 02/15/25 and Patient #4 was found to have right medial lip necrotic tissue injury. Review of the wound care note dated 02/15/25 revealed Patient #4’s lip injury was unstageable and it was deferred to plastic surgery for further treatment. Review of the plastic surgery consultation note dated 02/16/25 revealed a diagnosis of lip pressure injury from the ETT tube and recommendations were to keep ETT pressure off the right upper lip and consider moving to the other side of her mouth and apply Santyl (chemical debridement cream) three times daily. Review of the plastic surgery notes revealed the Santyl treatment to her lip did not show improvement and Patient #4 underwent a surgical debridement with adjunct tissue transfer on 03/18/25. Interview on 07/10/25 at 11:20 A.M. with Certified Nurse Specialist (CNS) Critical Care Staff T confirmed there was a nationwide recall on the ETT securing devices. The facility was forced to use twill tape during that process of finding a replacement. She reported all twill tapes must be changed every eight hours. Interview on 07/10/25 at 11:30 A.M. with Respiratory Manager Staff U, Respiratory Director Staff V, Respiratory Manager Staff BB, and Respiratory Education Coordinator Staff W revealed when the facility was forced to send back the recalled ET tube holders they implemented twill tape ties to secure the ETT tubes until a replacement could be obtained. Staff W confirmed all staff were educated during daily huddles but did not sign a sign-in sheet to confirm they were educated. All staff members confirmed that the only documentation of the twill ties being changed on Patient #4 was not found in the medical record until 02/15/25 when an upper lip pressure injury was discovered on Patient #4. They also confirmed the ETT was placed on 02/11/25. Review of the facility education given 02/03/25 and 02/05/25 revealed reminders to change twill ties every shift/we are suggesting during your second rounds (12) to ensure they are getting changed approximately 12 hours apart to avoid skin breakdown until better tube holder options are found. Review of the policy titled, “Respiratory Care Manual Change of Equipment Frequency,” last revised May 2025, revealed twill tapes should be changed every shift and as needed.”

“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: 44810 Based on interview, policy review, and record review, the facility failed to ensure a registered nurse evaluated the nursing care for one of 10 patients reviewed (Patient #1). This could affect all patients receiving services from the facility. Findings include: Review of the medical record for Patient #1 revealed an admission date of 12/05/23 and a discharge date of 12/13/23. Patient #1 presented to the emergency room on 12/05/23 with green drainage coming from her percutaneous endoscopic gastrostomy (PEG) tube. She was admitted to the hospital for intravenous antibiotic therapy. Her admitting diagnosis was sepsis and she had a past medical history of pressure ulcer of the sacral region, chronic respiratory failure with hypoxia, and tracheostomy dependence. Review of history and physical dated 12/05/23 for Patient #1 and subsequent daily physician progress notes revealed Patient #1 was not alert and oriented to person, place, or time; nonverbal; and had contractures noted in all extremities. Patient #1 had contractures in bilateral arms and hands and her legs were crossed. Review of the nursing progress note dated 12/09/23 at 3:41 A.M. written by Staff M revealed Patient #1 had been grimacing and grunting throughout the shift. Patient #1 was nonverbal and was ventilator/tracheostomy dependent. Staff M reported he had been giving scheduled pain medications, however when he was cleaning her up with a nursing assistant he noticed she had a very swollen right upper leg and thigh. Her legs were observed at her baseline of being severely contracted and crossed over one another. Staff M notified the physician, and the physician came to assess Patient #1. There were no further orders as the physician reported Patient #1 was at her baseline. Review of the nursing progress note dated 12/11/23 at 9:00 P.M. by Staff M revealed he went into Patient #1’s room and noticed her legs were no longer crossed or buckled like they previously were. The swelling he had reported to the physician on 12/09/23 had increased. Review of the nursing progress note dated 12/12/23 at 8:30 P.M. by Staff M revealed he entered Patient #1’s room and found her daughter cleaning her legs and applying lotion. Patient #1’s daughter reported concerns with the swelling in Patient #1’s right upper thigh and groin and expressed concerns that her legs were no longer contracted. Staff M confirmed to the daughter that he had noticed that yesterday and he would call the physician. Review of nursing progress note dated 12/12/23 at 10:00 P.M. revealed Staff M did notify the physician of Patient #1’s family’s concern. Review of orthopedic consultation note dated 12/13/23 at 12:48 A.M. revealed Patient #1 was found to have a subtrochanteric femur fracture that typically requires operative management. Due to Patient #1’s medical comorbidities non operative management would be the course of treatment. Interview on 12/28/23 at 7:32 A.M. with Staff M revealed Patient #’1s legs were crossed right over left and pulled up almost to a fetal position when he first cared for her on 12/08/23. He confirmed he did notice the swelling in her right upper thigh, right groin area and did notify the physician. The physician felt after assessing Patient #1 that the swelling was her baseline. Staff M then reported he returned to work on 12/11/23 and found Patient #1’s legs were straight and no longer contracted. He confirmed the swelling in her right upper leg and groin area was still present. Staff M reported he did not inform the physician of his new findings. Staff M then stated when he arrived on shift on 12/12/23 he found Patient #1’s daughter in her room cleaning Patient #1’s legs and applying lotion. He reported Patient #1’s daughter expressed concerns over her swelling in her right upper leg and the fact that her mother’s legs were now straight. Staff M reported when he observed the patient he noted that the swelling in her right upper leg and groin area had gotten worse, he also reported he confirmed with the daughter that he had noticed that her legs were straight the night prior. Staff M then reported the findings to Patient #1’s physician who ordered x rays. Staff M then stated Patient #’1’s daughter called the unit because she had a missed call from the physician, and he made sure the physician did call her back to inform her of the fracture. Staff M reported then at the end of his shift in the morning Patient #1’s power of attorney called the floor threatening to call the police on the staff for the condition of the patient and he notified the nursing supervisor. Telephone interview on 12/28/23 at 10:30 A.M. with Staff O revealed she cared for Patient #1 on 12/09/23 during the day shift and reported her legs were straight. She reported her legs were straight but tight and rigid. She stated when she got report that morning, she was told Patient #1 had contractures but when she assessed the patient her arms hands were contracted so she assumed those were the contractures she was informed of in report. She reported she was not told specifically where the contractures were. She reported Staff M did inform her of Patient #1’s swelling in her right upper leg and groin area but that the physician did assess it and reported it was her baseline. Staff O stated when she returned to work on 12/13/23 for the day shift shenoted the swelling in Patient #1’s right upper leg and groin had substantially increased. Review of facility policy titled, Physician Notification and Escalation Related to Patient Status, revised 11/13/23, revealed there will be verbal discussion/contact with the physician on any patient care clinical issues. The registered nurse must notify the physician if a patient has any new complaints or symptoms. The interaction must be documented. The facility failed to notify the patient’s family and the physician on 12/11/23 when staff identified Patient #1’s legs were straight and no longer contracted. This deficiency represents non-compliance investigated under Substantial Allegation OH00149415.”