Sutter Roseville Medical Center

“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: 50633 Based on observation, interview and record review, the facility failed to follow its Clinical Alarms Management policy to ensure patient safety during a hospital admission in the Intensive Care Unit (ICU). This failure resulted in a delayed response to a patient’s (Patient 1) potentially life-threatening situation, and potentially contribute to his death. FINDINGS: During a review of Patient 1’s Electronic Medical Record (EMR), dated 8/25/25, the EMR indicated the patient was admitted to the Intensive Care Unit (ICU) from the Emergency Department (ED) on 8/25/25 at 9:20 p.m., with a diagnosis of significant bradycardia [an abnormally slow resting heart rate less than 60 beats per minute]. EMR indicated medical orders for cardiac monitoring. During a concurrent interview and record review on 10/14/24 25 at 2:15 p.m., with the ICU Critical Care Manager (CCM), the Philips Cardiac Monitoring Audit Report for Patient 1, dated 8/26/25, was reviewed. The Audit indicated a “Yellow Alarm” for missed heart beats was silenced on 8/26/25 at 1:07:14 a.m. and at 01:32:14 a.m., a “Red Alarm” for low oxygen saturation levels was silenced by a staff nurse at 01:32:43 a.m. CCM stated “Yellow Alarms” indicate a non-life-threatening situation requiring attention as soon as possible and “Red Alarm” indicate potentially life-threatening situations immediate response. In the same interview with CCM, CCM explained her investigation of the incident. CCM stated she reviewed a video recording of the nursing station during the time of the event. CCM stated the recording showed the Break Nurse silenced a cardiac monitor “Yellow Alarm” for Patient 1 from the nurses’ station and remained seated at the nurses’ station for 15 minutes. CCM stated the recording showed the “Red Alarm” was silenced by another ICU nurse at the other nurse’s station. CCM stated the recording showed this nurse did not leave the nurses’ station to visually check the patient. CCM stated she interviewed the Break Nurse who had silenced the “Yellow Alarm” who said she left the nurses’ station to help bathe another patient in a room adjacent to Patient 1’s room, remaining there for 30 minutes. CCM stated the Break Nurse acknowledged she did not visually check on the Patient 1 after the “Yellow Alarm” nor did she use the cardiac monitor function to view Patient 1’s cardiac data while in the other patient’s room. CCM stated she expected the staff nurses to use the cardiac monitor function to view their assigned patient’s cardiac data if they are detained in another patients’ room. CCM stated she interviewed the ICU Nurse who had silenced the “Red Alarm”. CCM stated he said he had noted the message on the Central Monitor indicated Patient 1’s “Leads off,” and had assumed the patient was being bathed. CCM this nurse did not respond to the red alarm according to policy by visually checking on the patient after silencing this red alarm. During the same interview with CCM, the ICU staff nurse break schedule for the 8/25/25 night shift was reviewed. The schedule indicated the Break Nurse was responsible to monitor Patient 1 from 1 a.m. until Primary Nurse returned from her break. CCM stated the Break Nurse did not conduct a visual check of Patient 1 while providing break coverage for Patient 1’s Primary Nurse. CCM stated ICU staff discovered Patient 1 had no pulse at 1:55 a.m. and that the alarm for the cardiac monitor was silenced. During a review of the facility’s policy and procedure (P&P) titled, “Clinical Alarms Management”, dated 4/3/2025, P&P indicated “Clinician and licensed/unlicensed staff responsibilities include: Providing a timely response to clinical alarms based on alarm priority level; Any employee who hears an alarm will investigate the source of the alarm ... Priority level for Cardiac Monitoring indicates a Red alarm is High priority and response time is immediate with goal of visual check of patient < 2 minutes. A Yellow alarm is moderate priority and response time is rapid with a goal of visual check of patient within 2-5 minutes.””

“RESPIRATORY CARE SERVICES CFR(s): 482.57 The hospital must meet the needs of the patients in accordance with acceptable standards of practice. The following requirements apply if the hospital provides respiratory care services. This Condition is not met as evidenced by: 29108 Based on observation, interviews, policy and document review, the facility failed to meet the respiratory care needs for 2 out of 30 sampled patients (Patient 1 and Patient 2) in accordance with acceptable standards of practice when: 1. Patient 1’s ventilator (a machine used to support or replace the breathing of a patient) was inadvertently placed in “Standby” mode (pauses mechanical ventilation so patient doesn’t receive ventilation) during the exchange of ventilators upon return to Intensive Care Unit (ICU) from CT (computed tomography; imaging procedure that uses x-rays). This deficient practice during transport left Patient 1 without mechanical ventilation for under 2 minutes and contributed to Patient 1’s cardiopulmonary arrest (a sudden, unexpected loss of heart function, breathing and consciousness) [A1160]; 2. Patient 2’s ventilator was inadvertently placed in “Standby” mode during the exchange of ventilators in the MRI suite (magnetic resonance imaging; a non-invasive imaging technique that creates detailed images of the body’s internal structures). This deficient practice during transport left Patient 2 without mechanical ventilation for approximately 1 minute and may have contributed to Patient 2’s cardiopulmonary arrest [A1160]; 3. Patient 2 was transported on mechanical ventilation to MRI without an Ambu-Bag (bag-valve-mask for ventilation) [A1152]; 4. Prior to the two ventilator events, there was no documented evidence of respiratory care practictioner (RCP) training or competency verification of how to transport a ventilated patient [A1161] and; The cumulative effect of these failures resulted in the hospital’s inability to provide effective, safe and quality respiratory services in accordance with the statutorily mandated Conditions of Participation 42 CFR 482.57 Respiratory Services for General Acute Care Hospitals.”

“ORGANIZATION OF RESPIRATORY CARE SERVICES CFR(s): 482.57(a) The organization of the respiratory care services must be appropriate to the scope and complexity of the services offered. This Standard is not met as evidenced by: 29108 Based on interviews and document review, the facility failed to ensure an Ambu-Bag (bag-valve-mask for manual ventilation) accompanied 1 of 30 sampled patients (Patient 2) during transport in accordance with hospital policy and acceptable standards of practice. This deficient practice put Patient 2 at risk of a life-threatening delay in manual ventilation (a way to help a patient breathe performed using a bag valve mask to mouth or breathing tube) in the event of mechanical ventilator (a machine used to support or replace the breathing of a patient) malfunction. Findings: According to a review of the 6/25/24 policy titled, “Initiating and Maintaining In-House Transport Ventilation”, the policy indicated, “Ensure bag-valve-mask is with the patient for the duration of the transport...At least one mask should be kept [near ventilator and] available for emergency use.” During an interview with the Director of Pulmonary Services (DPS) on 2/19/25 at 9:40 a.m., DPS stated Patient 2 was transported from his room in the intensive care unit to MRI (magnetic resonance imaging; a non-invasive imaging technique that creates detailed images of the body’s internal structures) without an Ambu-Bag. In an interview with Registered Nurse 1 (RN 1) on 2/14/25 at 1 p.m., RN 1 stated equipment for monitoring and emergencies must accompany a ventilated patient during transport. RN 1 said an Ambu-Bag must be available for use. According to the 2002 American Association of Respiratory Care (AARC) Clinical Practice Guidelines (Respiratory Care Vol 47 No 6) titled, “In-Hospital Transport of the Mechanically Ventilated Patient”, the Clinical Practice Guidelines indicated, “Emergency airway management supplies should be available and checked for operation before transport, [including] a self-inflating bag and mask of appropriate size”.”

“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: 29108 Based on observations, interviews, policy and document review, the facility failed to implement safe practices and procedures during the delivery of respiratory care services for 2 out of 30 sampled patients (Patients 1 and 2) in accordance with acceptable standards of practice and approved policies when: 1. Patient 1’s bedside ventilator (a machine used to support or replace the breathing of a patient) was placed in “Standby” mode (pauses mechanical ventilation so patient doesn’t receive breathing assistance) during the exchange of ventilators upon return to ICU (Intensive Care Unit) from CT (computed tomography; imaging procedure that uses x-rays). This deficient practice during transport left Patient 1 without mechanical ventilation for under 2 minutes and contributed to Patient 1’s cardiopulmonary arrest (a sudden, unexpected loss of heart function, breathing and consciousness) and; 2. Patient 2’s ventilator was placed in “Standby” mode during the exchange of ventilators in the MRI suite (magnetic resonance imaging; a non-invasive imaging technique that creates detailed images of the body’s internal structures). This deficient practice during transport left Patient 2 without mechanical ventilation for approximately 1 minute and contributed to Patient 2’s cardiopulmonary arrest. Findings: According to the facility policy “Initiating and Maintaining In-House Transport Ventilation”, dated 6/25/24, the policy described “Mechanical ventilation as a complex task that requires understanding of the technical components of the ventilator, the pathophysiology [the disease processes] of the respiratory system and patient-ventilator interaction. Respiratory Care Practitioners (RCP) have primary responsibility for initiating and maintaining transport mechanical ventilation.” A review of the 2019 (current) User Manuals for the Getinge Servo-U Ventilator System v. 4.0 and Getinge Servo-U MR Ventilator System v. 4.1 (a ventilator adapted for use during MRI), indicated the ventilator systems consist of a user interface (touch screen) for setting ventilation modes (e.g. Standby, Run) and therapies, displaying data and indicating alarms. Ventilator activity is archived and can be retrieved for review in the form of an Event Log. 1. According to review of the 12/20/24 “Intensive Care Unit Admission History and Physical”, Patient 1 was admitted to the hospital with diagnoses including altered mental status and acute respiratory failure (severe difficulty breathing). Patient 1 was intubated (a tube placed in his windpipe) and, using a disposable ventilator circuit (tubing), was connected to a mechanical ventilator. A review of the “Code Blue (a hospital emergency procedure for cardiac and pulmonary arrest) Physician Note”, dated 12/20/24 at 7:37 p.m., revealed the following, “Brief Summary: I responded immediately to an overhead code blue page to TNICU-B (Trauma-Neuro ICU) where [Patient 1] was without a pulse shortly after returning from CT scan. Report that [Patient 1] was disconnected from ventilator at the time of lost pulses. Ventilation by BVM (bag-valve-mask) and ETT (endotracheal tube or breathing tube) in place”. During a review of the “Care Team Note”, charted by Trauma-Neuro ICU Registered Nurse 1 (RN 1) on 12/20/24 at 8:38 p.m., it read, “1815 (6:15 p.m.): Received [Patient 1] back from OR [Operating Room]. Orders from [Surgeon 1] to go for STAT (immediate) CT head now. 1845 (6:45 p.m.): Return from CT scan. 1855 (6:55 p.m.): Monitor reading asystole (heart stopped), no pulses. Code blue initiated”. During an interview with Director of Pulmonary Services (DPS) on 2/14/25 at 9:25 a.m., DPS explained Patient 1 returned to his TNICU Room 10 from CT in a hospital bed. DPS acknowledged when Patient 1 was taken off the LTV-1200 portable ventilator and connected via the circuit (disposable tubing that connects patient to the ventilator) to the Servo-U ventilator at the bedside, the Servo-U remained on “Standby”. DPS explained it was discovered, however, there was a 2 minute delay in changing the Servo-U ventilator mode from “Standby” to “Run” (to initiate mechanical ventilation). During an interview on 2/14/25 at 1 p.m., RN 1 stated she was at Patient 1’s bedside when Patient 1 returned to the TNICU from CT. Patient 1 was on a [Viaysis LTV 1200] transport ventilator. Once Patient 1 was in his room, the RCP changed Patient 1 from the transport ventilator to the bedside ventilator (Servo U). RN 1 stated it was after the ventilator exchange when she said Patient 1 appeared “pale” and went into “asystole”. A Code Blue was called, RN 1 said, and Patient 1 was resuscitated successfully. RN 1 reported that it was discovered shortly after, that the RCP accidentally left the bedside ventilator on “Standby” mode. Further interview with RN 1 on 2/14/25 at 1 p.m., RN 1 revealed that when they settled Patient 1 back in his room from transport, she experienced “problems with the [cardiac] monitor which caused a delay in vital signs”. RN 1 suggested that trouble-shooting the cardiac monitor and various other tasks required to settle the patient back from transport may have created some unexpected distractions. During a concurrent interview and review of Patient 1’s Servo-U bedside ventilator 12/20/24 Event Log, on 2/14/25 at 11:35 a.m., the DPS and Quality Manager 1 (QM 1) calculated the time Patient 1 was connected to the bedside ventilator while it remained on “Standby”. DPS and QM 1 confirmed it was 1 minute 28 seconds and the date and time corresponded with the date and time of Patient 1’s cardiac arrest in ICU. 2. According to review of Patient 2’s 2/5/25 “Emergency Department-to-Hospital Admission Profile”, Patient 2 was admitted to the hospital on 2/5/25 with diagnoses including sepsis (a life-threatening complication of infection) and acute respiratory failure. Patient 2 was intubated and placed on a ventilator in the ED [Emergency Department]. A review of a nursing “Care Team Note”, dated 2/6/25 at 12:12 a.m. noted, “[Patient 2] was transported to MRI [at] approx 2110 (9:10 p.m.) for ordered stat MRI of the brain. Pt (patient) VS (vital signs) stable upon transfer from hospital bed to MRI [table]. Noted severe bradycardia (slow heart rate) on monitor 2 to 3 mins later. Patient became pulseless, initiated code blue. Patient transferred to ED Trauma Bay. ROSC (return of spontaneous circulation) was obtained.” A review of the “Emergency Physician Consult Note: [CODE BLUE]”, dated 2/5/25 at 9:33 p.m., revealed the following: “Brief Summary: I responded immediately to an overhead code blue page to MRI where [Patient 2] was without pulse. ACLS (Advanced Cardiac Life Support, a protocol used for the emergency treatment of cardiopulmonary arrest) protocol was initiated -- refer to RN code sheet. Patient 2 already intubated and on a ventilator with sedation of propofol (sedative)running. Lost pulses while performing MRI study”. A physician “ICU Overnight Note”, dated 2/6/25 at 12 a.m. was reviewed. The note read, “While undergoing work-up for metabolic encephalopathy (brain function impaired from an imbalance in the body’s metabolism) [Patient 2] was taken to MRI - while in the scanner [Patient 2] was found to be pulseless and CODE BLUE was called. CPR (cardiopulonary resuscitation, a first aid technique that involves chest compressions and rescue breathing) was initiated immediately and [Patient 2] was transported to the trauma bay while resuscitation was ongoing”. A group interview was conducted on 2/13/25 at 10 a.m. with the Chief Nursing Executive (CNE), Vice President of Operations (VPO), Director of Quality and Patient Safety (DQPS), DPS, Senior Director ICU/ED (SDICU) and the RCP Supervisor (RS). DQPS explained Patient 2 arrived by ambulance to the Emergency Department (ED) on 2/5/25. Patient 2 required intubation in the ED and was placed on a ventilator. DQPS said Patient 2 was admitted to the ICU, and from ICU was transported to MRI. In order to transport Patient 2, SDICU explained, Patient 2’s would have been placed on the “whole house LTV-1200” transport ventilator by a RN and RCP in the ICU. Further group interview on 2/13/25 at 10 a.m., DPS and SDICU continued by explaining Patient 2 arrived to the MRI in his ICU bed. A MR Servo, a MRI compatible ventilator (a ventilator designed for mechanical ventilation in the strong magnetic field of the MR room) was located outside the MRI and set in “Standby” mode, checked and ready for use. Patient 2 was transferred from her ICU bed to the MRI table (outside of the MRI suite) with the assistance of a MRI technician, RN and RCP. DPS said, the RCP then switched Patient 2 from the transport ventilator to the MRI ventilator but failed to immediately change the MR Servo mode from “Standby” to “Run”, to resume oxygen flow and ventilate Patient 2. Patient 2 was then transported inside the MRI suite for imaging on “Standby”. During a concurrent interview and review of the MR Servo MRI ventilator 2/5/24 Event Log, on 2/19/25 at 10:30 a.m., DPS and RS stated that, according to the Event Log, Patient 2 was connected to the MRI ventilator but it remained on “Standby” for approximately 1 minute. This error corresponded to the date and time of Patient 2’s cardiac arrest. A concurrent observation of the MR Servo ventilator touch screen/interface (identical to Servo-U bedside ventilator) and interview was conducted on 2/13/25 at 11:30 a.m. with DPS and RCP 9. With the ventilator on “Standby”, RCP 9 demonstrated how “Standby” mode was displayed on the touch screen. The word “Standby” was displayed in large, bold letters with an otherwise blank, grey background. In an interview with DPS on 2/14/25 at 9:40 a.m., DPS stated the standard of practice for the RCP when initiating mechanical ventilation or switching to a different ventilator was to first take the ventilator off “Standby” and “get the flow going” near the patient’s ETT, then attach the ventilator circuit to the ETT. The Medical Director of Cardiopulmonary Services (MDCS) was interviewed on 2/14/25 at 9:30 a.m. MDCS stated he was incredibly surprised when he heard about the two ventilator events. MDCS stated a “basic and innate” understanding of ventilators and biology should automatically prompt staff to change the ventilator settings from “Standby” to “Run” when intended for patient use. According to the “Performing Patient-Ventilator System Check” policy, dated 6/25/24, “A comprehensive patient-ventilator system check will be performed before and after transporting a patient”. Review of the policy “Initiating and Maintaining In-House Transport Ventilation”, dated 6/25/24, directed RCP staff to perform “the initiation and maintenance of the transport mechanical ventilator” including, “observe that the ventilator is on and circuit is securely attached....The patient’s condition and chest movements as well as the inspiratory pressure (amount of pressure applied to the lungs during inhalation), displayed on the ventilator monitor, should be kept under constant observation so that adverse ventilation conditions can be detected and corrected before patient is put at risk”. According to a review of the 2002 American Association of Respiratory Care (AARC) Clinical Practice Guideline, “In-Hospital Transport of the Mechanically Ventilated Patient” (Respiratory Care June 2002 Vol. 47 No 6), the Clinical Practice Guideline indicated, “Transportation of mechanically ventilated patients for diagnostic or therapeutic procedures is always associated with a degree of risk. Every attempt should be made to assure that monitoring, ventilation, oxygenation, and patient care remain constant during movement. Patient transport includes preparation, movement to and from, and time spent at destination.””

“RESPIRATORY CARE PERSONNEL POLICIES CFR(s): 482.57(b)(1) Personnel qualified to perform specific procedures and the amount of supervision required for personnel to carry out specific procedures must be designated in writing. This Standard is not met as evidenced by: 29108 Based on staff interviews, policy, clinical practice guidelines, and education file review, the facility failed to provide documented evidence of training and competency verification, in accordance with facility policies and clinical practice guidelines, for the transport of the ventilated patient for 5 out of 5 sampled respiratory care providers (RCPs 3,4,5,6,7). The lack of training and demonstrated competencies, including the exchange of facility-specific ventilators (a machine used to support or replace the breathing of a patient) during transport, put all ventialted patients at higher risk of ventilator-related adverse events and poor patient outcomes and contributed to actual patient harm. Findings: A review of a policy titled, “Initiating and Maintaining In-House Transport Ventilation”, dated 6/25/24, indicated, “Respiratory Care Practitioners have [the]primary responsibility for initiating and maintaining transport mechanical ventilation. The purpose of the policy was “to provide instructions for initiating and maintaining transport ventilation”. The procedure indicated “steps” and “actions” to ensure safe patient transport. During a review of five RCP education files (RCPs 3,4,5,6,7), training and competencies for three separate ventilators, in use at the hospital, were identified. The three ventilators included the “Servo I and U” (Servo U is the same, newer version of Servo I) ventilators (bedside ventilator), the “Viasys LTV 1200” ventilator (transport ventilator) and the “MR Servo” (MRI, magnetic resonance imaging ventilator). Nowhere in the 5 RCP training files was there documented evidence of RCP instruction or competency verification of in-house transport ventilation procedures, how to switch a patient from one of the three facility-specific ventilators to another, or the safe transport of the ventilated patient within the hospital. During a review of the 2/18/25 (current) “CR-Learner and Group Transcripts” for the same five RCPs (RCPs 3,4,5,6,7), each RCP transcript consisted of a list of required courses completed since their date of hire. None of the RCP courses listed in the five transcripts included management of the ventilated patient for transport. In a concurrent interview and education file review with the Educator of Cardiopulmonary Department (EDCP) on 2/18/25 at 2:45 p.m., EDCP acknowledged there was no specific training or competency verification required of the RCPs (RCPs 3,4,5,6,7), for managing the three facility ventilators during patient transport. During an interview with Respiratory Care Practitioner 8 (RCP 8) on 2/19/25 at 9:25 a.m., RCP 8 stated, “I can’t remember” ever having training while employed at the hospital in regards to transporting a patient on a ventilator or changing a patient from one ventilator to another for transport. “There’s no real step by step [process],” RCP 8 said, “There’s no checklist or sequence of tasks” performed when switching a patient from one ventilator to another for transport. RCP 8 acknowledged such training would have been beneficial, particularly because he was hired by the facility as a “new grad”. During an interview with the Director of Pulmonary Services (DPS) on 2/19/25 at 9:40 a.m. DPS acknowledged,”in hindsight” after the two recent ventilator-related cardiopulmonary arrests, verification RCPs provide safe and competent ventilator management during patient transport would have been prudent. According to the 2002 American Association of Respiratory Care (AARC) Clinical Practice Guidelines (Respiratory Care Vol 47 No 6) titled, “In-Hospital Transport of the Mechanically Ventilated Patient,” the Clinical Practice Guidelines indicated, “All mechanically ventilated patients should be accompanied by a registered nurse and a respiratory therapist (RCP) during the entire transport. At least one team member should be proficient in operating and troubleshooting all of the equipment...” A review of the October 2017 Position Statement from the AARC, regarding the “Transport of the Mechanically Ventilated, Critically Injured or Ill, Neonate, Child or Adult Patient” revealed, “Transportation will be performed according to the AARC Clinical Practice Guidelines found in the “In-Hospital Transport of the Mechanically Ventilated Patient.” Acccording to a review of the 7/10/23 policy titled, “Protocol: Ventilator Management”, ventilator management and protocols will be performed by “Respiratory Care Practioners with demonstrated training and competency in providing invasive mechanical ventilation and discontinuation from mechanical ventilation”.”