Franciscan Children’s Hospital & Rehab Center

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 40928 Based on records reviewed and interviews, the Hospital failed to maintain safety for 1 Patient (#3) out of a sample of 10 patients. Patient #3 was found on 8/19/25 around 5:00 P.M. by Registered Nurse (RN) #2 with the wire for an oxygen saturation probe wrapped around his/her neck. RN #2 removed the wire and left Patient #3 ’ s room. At approximately 6:45 P.M., RN #2 re-entered Patient #3 ’ s room and observed the wire wrapped around his/her neck again. Patient #3 was ultimately transferred out to an acute inpatient psychiatric unit. Cross Reference: 482.13(c)(3)- Care in a Safe Setting (A0144)”

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 40928 Based on records reviewed and interviews, the Hospital failed to maintain safety for 1 Patient (#3) out of a sample of 10 patients. Patient #3 was found on 8/19/25 around 5:00 P.M. by Registered Nurse (RN) #2 with the wire for an oxygen saturation probe wrapped around his/her neck. RN# 2 removed the wire and left Patient #3 ’ s room. At approximately 6:45 P.M., RN #2 re-entered Patient #3 ’ s room and observed the wire wrapped around his/her neck again. Patient #3 was ultimately transferred out to an acute inpatient psychiatric unit. Findings included: Review of Hospital document titled ’ Med Unit SI Protocol ’ , undated, indicated the following: -Nurses complete a Columbia Suicide Severity Rating Scale (CSSRS) (a tool to screen for suicidal ideation in people ages 8 and up) upon admission for children cognitively 6 years old and greater and document in Admission Assessment. Items 1,2, and 6 must be completed for all qualified children. -The CSSRS must also be completed by nursing any time a patient is heard to make a statement of wanting to harm themselves, kill themselves, or not be alive any longer. - Additionally, the CSSRS can be completed by nursing at any other point during the admission based on concern for patient safety related to statements made, witnessed actions, or expressions of hopelessness/plans to harm themselves and details of such information and need to re-assess should be detailed in a nursing note for that shift. Review of Hospital policy titled ’ Standards of Nursing Practice on the Medical Units ’ , approved 6/2022, indicated: -A suicide/ self-harm risk assessment can be completed by nursing at any point during the admission based on concern for patient safety related to statements made, witnessed actions, or expressions of hopelessness/plans to harm themselves. -Any patient assessed to be at risk for self harm/suicide should be identified immediately to Licensed Independent Practitioner and psychology for plan of care. Patients expressing suicidal ideation with or without plan should be monitored 1:1 until psychological evaluation is performed. -While the patient is in the care of the Hospital, staff will monitor patient space for risk and remove any unused furniture or care items. Patient #3 was admitted to the Hospital in June 2025 for acute inpatient rehabilitation and was being followed by Behavioral Health and psychology for mood disorder and depression. Review of Patient #3 ’ s Psychologist Progress note dated 8/13/25 indicated the clinician attempted to meet with Patient #3 at the bedside and found him/her with the sheet over his/her head. Patient #3 refused to engage with the clinician past shaking his/her head no. The clinician attempted to complete a safety assessment with Patient #3 and he/she said no to all screening questions, although it was not clear that Patient #3 ’ s responses were true responses given that Patient #3 said no to all initiation attempts. The Note further indicated Patient #3 ’ s depressive symptoms continue to progress. Review of Patient #3 ’ s Nursing Progress Note dated 8/19/25 at 7:28 P.M. indicated that Registered Nurse (RN) #2 went into Patient #3 ’ s room at 5:00 P.M. and found the oxygen (O2) probe wire wrapped around Patient #3 ’ s neck. RN #2 removed the wire and attempted to redirect the Patient by turning on the t.v. The Note further indicated that RN #2 went back into Patient #3 ’ s room at 6:45 P.M. and found the wire wrapped around Patient #3 ’ s neck again. RN #2 asked Patient #3 if he/she was intentionally doing this and Patient #3 nodded. RN #2 alerted the charge RN, nurse manager and MD and a 1:1 sitter was present at the bedside. Review of Psychologist Progress Note dated 8/20/25 indicated the clinician met with Patient #3 per nursing request due to Patient #3 ’ s recent suicide attempts the previous evening. Review of Patient #3 ’ s Discharge Summary dated 8/20/25 indicated Patient #3 was being transferred to an outside hospital for acute psychiatric evaluation after suicide attempt by wrapping monitoring cords around his/her neck. During an interview on 9/10/25 at 8:30 A.M., the Director of Patient Safety and Quality said the Hospital has a Suicide Risk policy for the inpatient behavioral health units, but for the medical units there is only a 1-page protocol. The Director said prior to Patient #3 ’ s event, the Hospital had identified an opportunity for a more comprehensive hospital-wide policy for suicide screening/ risk assessment but it had not been finalized or implemented yet. The Director said RN#2 first saw the O2 sat probe wire wrapped around Patient #3 ’ s neck and removed the wire and then went back into Patient #3 ’ s room and saw the wire wrapped around Patient #3 ’ s neck again and at this time a 1:1 safety sitter was initiated and the O2 sat probe was moved from Patient #3 ’ s hand to his/her foot. The Director said the first time RN#2 observed the wire around Patient #3 ’ s neck, she didn ’ t recognize the situation for what it was. The Director said the expectation would be to do an immediate escalation and initiate a 1:1. The Director said an Apparent Cause Analysis (ACA) had been completed for this event and opportunities were identified but no immediate interventions or education had been put into place yet. During an interview on 9/10/25 at 9:39 A.M., Registered Nurse (RN) #2 said the day of the event, she went to Patient #3 ’ s room around 5:00 P.M. to start his/her feed and Patient #3 was lying supine in bed with an O2 sat probe on his/her finger with the wire running up and the wire was wrapped around Patient #3 ’ s neck tightly once or twice. RN #2 said Patient #3 had no loss of respirations or any color changes and Patient #3 was lying with his/her eyes closed and she removed the wire from around his/her neck. TN #2 said she asked Patient #3 what the wire was doing around his/her neck and he/she didn ’ t respond. RN#2 said she didn ’ t ask Patient #3 if he/she had done this on purpose or if this was an attempt to hurt him/herself. RN#2 said after removing the wire, she started Patient #3 ’ s feed as planned and left the room. RN#2 said sometime later in the shift, she alerted the Charge RN about what had happened and was instructed to go back to Patient #3 ’ s room to complete a suicide risk assessment. RN #2 said when she returned to Patient #3 ’ s room around 6:45 P.M., Patient #3 was still supine in bed with the same wire wrapped tightly around his/her neck again. RN #3 removed the wire and asked Patient #3 if he/she was doing this on purpose and Patient #3 nodded yes, began to cry and indicated he/she was sad. RN #2 said she notified the Charge RN that Patient #3 had wrapped the wire around his/her neck again and a 1:1 was implemnted at that point. RN #2 said after this event she spoke to the Hospital ’ s quality department about what had happened but didn ’ t remember any re-education being done. During an interview on 9/10/25 at 9:59 A.M., the Charge RN said as the charge nurse she gets an update from the nurses around 6:15-6:30 P.M. each shift. She said when she was getting her shift report from RN#2 that day, RN #2 reported that Patient #3 had wrapped an O2 sat cord around his/her neck and said it was wrapped tightly around his/her neck twice. The Charge RN said she asked RN #2 if anyone was with Patient #3. She said she stopped getting updates at this point and escalated to the nursing director and the Psychologist. The Charge RN said she informed RN #2 that Patient #3 needed to have someone with him/her and that a suicide risk assessment needed to be completed. The Charge RN said RN #2 went back to Patient #3 ’ s room and observed that Patient #3 had wrapped the wire tightly around his/her neck again and affirmed he/she had done it on purpose. The Charge RN said at that point a plan was made to ensure a staff member would be with Patient #3 at all times as a 1:1 and that it was agreed Patient #3 would remain on the unit as a 1:1 until Psychology could see the Patient in the morning. The Charge RN said in the moment she talked to RN#2 that she was concerned that this was a suicide attempt and said she told the nurse this should have been escalated sooner. The Charge RN said the expectation would be that a situation like this should have been escalated sooner.”

“DIRECTOR OF RESPIRATORY SERVICES CFR(s): 482.57(a)(1) There must be a director of respiratory care services who is a doctor of medicine or osteopathy with the knowledge, experience and capabilities to supervise and administer the service properly. The director may serve on either a full-time or part-time basis. This Standard is not met as evidenced by: 40928 Based on documents reviewed and interviews, the Hospital failed to ensure the Director of Respiratory Services had the necessary qualifications for the role. Findings included: Review of Hospital document ’ Job Description- Director of Respiratory Therapy ’ , undated, indicated: Education and Experience: -Graduate of an American Medical Association (AMA) approved program in Respiratory Care -Current licensure as a Respiratory Care Practitioner in the Commonwealth of Massachusetts During an interview on 9/5/25 at 9:09 A.M., the Director of Patient Safety and Quality said the Hospital ’ s Director of Respiratory Services had resigned abruptly the previous week and that the Chief Nursing Officer (CNO) was acting as the Interim Director of Respiratory Services. Review of the CNO ’ s personnel file, on 9/9/25, failed to indicate that she was a graduate of an approved Respiratory Care program nor that she had current licensure as a Respiratory Care Professional. During an interview on 9/10/25 at 8:16 A.M., the CNO said the Former Director of Respiratory Services resigned on 8/28/25 and was a Registered Respiratory Therapist (RRT). The CNO said since the previous Director left, she has been the unofficial/acting Director and works with the RRT educators and charge RRTs as she is a Registered Nurse and is not an RRT.”

“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: 40928 Based on policy review, records review and interviews, the Hospital failed to perform a tracheostomy (surgical hole through the front of the neck into the windpipe (trachea), in which a tracheostomy tube is placed to keep it open for breathing) tube change (a procedure to replace an existing tracheostomy tube with a new one) as ordered for 1 Patient (Patient #1) out of a sample of 10 patients. Findings included: Review of Hospital Policy titled ’ Tracheostomy Tube Change ’ , approved 2/2025, indicated: It is the responsibility of the Respiratory Care Department to change all tracheostomy tubes on a routine monthly basis (unless otherwise specified in doctor ’ s orders) A Practitioner order is required, with the appropriate trach tube size, patient category and type of cuff. Respiratory Therapist is to have a nurse, or another respiratory therapist, verify that the correct size trach tube is being used for the tube change. This is then documented in the patient ’ s electronic medical record as a time out procedure. If this is an emergent trach tube change, the verification and time out will be done after airway is secure and patient is stable. Patient #1 was admitted to the Hospital on 3/20/25 with tracheobronchomalacia (a rare respiratory condition that occurs when the windpipe and bronchial tubes collapse, making breathing difficult) status post tracheostomy tube placement and posterior tracheopexy (a surgical procedure that stabilizes the trachea by attaching it to surrounding structures). Review of Patient #1 ’ s medical record included an Admission I-PASS document dated 3/20/25 which indicated Patient #1 had a custom trach that was last changed on 2/27/25. Nurse Practitioner (NP) #1 placed an order for a Pediatric Bivona 3.5 millimeter (mm) tight to shaft (TTS) tracheostomy to be changed every 30 days. Review of Registered Respiratory Therapist (RRT) Progress Note dated 3/27/25 at 9:24 A.M. indicated Patient #1 was due for a trach change that day, which was on hold due to increased work of breathing, tachypnea (rapid breathing). Review of RRT Progress Note dated 3/29/25 at 4:43 P.M. indicated that Patient #1 ’ s trach was not changed because a 2nd backup custom trach needed to be available before the trach can be changed. Review of RRT Progress Note dated 4/1/25 at 9:48 A.M. indicated Patient #1 ’ s trach change was due 3/27/25 and that on 3/28/25 a custom backup trach had been sent for sterilization and was not back yet. The Progress Note indicated the RRT checked the trach room at 9:50 A.M. and the backup trach was not available. During an interview on 9/9/25 at 1:33 P.M. Nurse Practitioner (NP) #1 said she cared for Patient #1. NP #1 said trach changes are usually done 30 days after the previous trach change but it can be ordered more frequently if needed. NP #1 said the Respiratory Therapy Department tracks when patients are due for trach changes. NP #1 said she was unsure if Patient #1 had a trach change completed as ordered while he/she was in the Hospital and that she was unsure if there were any delays regarding his/her trach change. During an interview on 9/9/25 at 2:34 P.M., RRT #1 said trach change frequency is a patient-by-patient decision by providers but are usually done every 30 days and documented in a Respiratory Therapy Note. She said the electronic medical record system (EMR) tracks when patients are due and populates a list that viewable and the Charge RT will review the list daily. RRT #1 said each patient that has a trach will have a backup of the exact size trach and an additional trach a half size smaller in their room, as well as a go bag with a trach. She said standard trachs come new in sterile packaging, but custom trachs are reprocessed by sending them out for sterile processing and will come back up in sterile packaging with the patient ’ s name and identifiers on it. She said the Respiratory Therapy room has a cabinet with back up trachs including sterilized custom trachs. RRT #1 said if there is a delay in changing a trach or getting back a sterilized custom trach, staff will alert the provider and document in a progress note. RRT #1 said Patient #1 had a custom trach, but it was a common custom size. RRT #1 said if a patient is having resp distress or symptoms a trach change might be delayed for a day if the provider is okay with it and that the safety of maintaining a patient ’ s airway overrides anything. RRT#1 said she was unsure of what caused the delay for Patient #1 ’ s backup custom trach to be sterilized and returned to the Respiratory Therapy room and wasn ’ t sure why Patient #1 ’ s trach wasn ’ t changed as ordered. The Hospital failed to ensure Patient #1 ’ s tracheostomy was changed as ordered.”