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Based on observation, interview, and document review, the hospital failed to ensure the physical safety of patients with acute psychiatric symptoms, for 1 of 11 child patients reviewed (C1), who eloped from the hospital's premises during inclement weather after staff removed him from the secure psychiatric unit without proper authorization. This resulted in an Immediate Jeopardy situation for all psychiatric inpatients on any of the hospital's 14 behavioral health units and any future patients who might seek treatment at the hospital for behavioral symptoms.

Findings include:

The hospital did not meet the Condition of Participation of Patient Rights at 42 CFR 482.13. This deficient practice had the potential to impact all patients with behavioral symptoms.

The IJ was called on 12/12/16 at 4:10 p.m. The IJ began on 12/05/16 when the hospital failed to ensure the adequacy of a system to protect the welfare of patients, after a child patient who had physician's orders to remain within the boundaries of a secure psychiatric unit was improperly removed from the psychiatric unit by staff and eloped from the hospital's premises.

The hospital's established protocols for taking psychiatric patients Off-Unit for leisure activities were not implemented by staff, resulting in C1's elopement from the hospital when staff took C1 out of the controlled unit environment that is structured for patient safety, against physician's orders. Staff failed to check with the Charge Nurse regarding the status of C1's Off-Unit privileges and staff failed to take the unit cell phone along which is used in case of emergency. While enroute to the swimming pool which is a ten-minute walk from the secure psychiatric unit, C1 ran from staff at approximately 1:10 p.m. and disappeared from staff's sight in the hospital tunnel. The hospital's procedure for a missing child was enacted at 1:30 p.m. after staff located a hospital wall phone in the absence of the portable emergency cell phone. By the time the hospital's lockdown procedure occurred, C1 had already fled the hospital's premises wearing only hospital scrubs and hospital socks in inclement weather of 37 degrees and light rain. C1 was missing, without any staff supervision or oversight, for approximately 35 minutes. C1 was picked up by the police at 1:45 p.m., off the hospital's property in a dangerous location and area of traffic near a bridge that spans the Mississippi River. The police transported C1 back to hospital, physically unharmed.

The hospital did not thoroughly investigate the circumstances of C1's elopement or take sufficient corrective action to prevent a similar reoccurrence. The hospital has 14 behavioral health units. The failure to ensure staff followed the hospital's approved systems that protect patient safety, including a thorough analysis of any patient event that could result in harm to a patient, resulted in the hospital's inability to protect the physical safety of patients. Therefore, the hospital was unable to meet the Condition of Participation of Patient Rights at 42 CFR 482.13.

The IJ was removed on 12/15/16 at 5:30 p.m. when an acceptable removal plan was implemented to protect the health and safety of patients. Interviews and document review verified and established that hospital leadership staff had begun a re-education process for all staff on adolescent and adult behavioral health units regarding the protocols for patient safety pertaining to Off-Unit activities and appointments for patients. The Charge Nurses on all shifts of all behavioral health units were supervising patient care and monitoring implementation of all patient safety procedures. Leadership staff had begun an in-depth analysis of C1's elopement, including a review of processes that addressed a patient's potential for harm when a Patient Occurrence or Patient Safety Event emerged.

See A144. The hospital failed to ensure that patients received care in a safe setting that preserved the patient's welfare, for 1 of 11 child patients reviewed (C1), who eloped from the hospital when staff removed him from the secure psychiatric unit without proper authorization.

Based on observation, interview, and document review, the hospital failed to ensure that patients received care in a safe setting that preserved the patient's welfare, for 1 of 11 child patients reviewed (C1), who eloped from the hospital when staff removed him from the secure psychiatric unit without proper authorization.

Findings include:

Observations on 12/12/16 at 9:35 a.m. established that the hospital's child behavioral health unit/Intensive Treatment Center (7ITC) is the hospital's highest acuity mental health unit for children requiring acute inpatient care. The secure unit is double-locked and can be accessed only by those staff who possess the restricted key card. The unit has the capacity to serve 12 patients, all whom have private rooms. Staff check, observe, and document the whereabouts of every patient every 15 minutes, which represents the minimum interval for safety checks of patients. The nurse's station is located in the center of the unit. The Charge Nurse's written shift report is kept at the nurse's station. Program Director (PD)/J accompanied the investigator during the tour and explained that the shift report is a fluid document that is managed by the Charge Nurse. The Charge Nurse updates the document with changes in patient condition/status and new physician's orders regarding patient care as they occur throughout the shift. The shift report denotes each patient's goals for the day, the patient's treatment plan, the frequency of patient safety checks for each patient, the status of each patient's privileges for any Off-Unit activities, and any special alerts or precautions for patients at risk for elopement, suicidal ideation, self-injurious behavior, or assaultive behavior. At the time of the tour, the census was six patients. The shift report for 12/12/16 at 9:35 a.m. indicated that all six patients were on 15-minute checks by staff and two of six patients had Off-Unit privileges. The shift report also included the names of two other patients who had been discharged the morning of 12/12/16, C1 and another patient.

C1's hospital record indicated that C1 was a direct admit to the hospital's inpatient child behavioral health unit/Intensive Treatment Center (7ITC) on 11/29/16 after being transferred from another hospital where C1 presented with suicidal ideation that required acute inpatient treatment.

The history and physical, dated 11/29/16, identified C1's diagnoses as Autism Spectrum Disorder and Bipolar Affective Disorder. At the time of admission, C1's paranoia was heightened causing increased agitation and anxiety that had persisted for the past few weeks. C1 had expressed thoughts of suicidal and homicidal ideation, without a plan. C1 was very ill. Parental consent for treatment, including medications, was obtained on 11/29/16, after a benefit/risk analysis was conducted with C1's parent regarding the use of psychotropic medications. C1 was placed on 15-minute safety checks by staff with no Off-Unit privileges.

The progress notes, dated 11/30/16, indicated that after Attending Psychiatrist/H (AP/H) conferred with C1's outpatient psychiatrist and parents, it was determined that all of C1's outpatient medications would be continued, with Latuda titrated upwards until an effective dose was achieved to manage C1's symptoms. Addition of other medications would be reserved for any acute psychotic symptoms representing danger.

The progress notes, dated 12/02/16, indicated that C1's agitation and anxiety had improved and C1 was cooperating with the treatment program. At 11:06 a.m. on 12/02/16, C1 was evaluated by a medical provider who wrote orders that authorized Off-Unit privileges for C1. During the early afternoon of 12/02/16 around 1:00 p.m., staff escorted C1 Off-Unit to the swimming pool for a leisure activity. When C1 returned to the unit after the pool activity, he was anxious and agitated. C1's agitation escalated and significant delusions ensued. At 1:55 p.m. on 12/02/16, it was necessary for staff to give C1 a prn dose of Zyprexa in order to calm C1's symptoms of agitation.

The progress notes, dated 12/03/16, indicated that C1 was quiet and isolated himself from other patients all morning.

The 15-minute check sheets, dated 12/03/16, indicated that staff conducted a safety check at 2:00 p.m. at which time C1 was standing in the doorway of his room. C1 was invited to Music Therapy but declined.

The progress notes, dated 12/03/16 at 2:11 p.m., indicated that staff found C1 in his room with a sweatshirt stuffed in his mouth and a blanket wrapped around his neck several times. C1 had a discolored appearance but was not unconscious. When commanded by staff, C1 independently removed the sweatshirt from his mouth and the blanket from around his neck. C1 was immediately assessed by a nurse. C1's vital signs were at baseline with 94% oxygen saturation. The medical provider was contacted at 2:27 p.m. and placed C1 on Status Individual Observation (SIO), entailing 1:1 monitoring for safety.

The progress notes, dated 12/05/16 at 9:08 a.m., indicated that AP/H evaluated C1, including C1's suicide attempt during the weekend on 12/03/16. AP/H noted that C1 had no medical complications or long-term sequale from his strangulation attempt. AP/H canceled C1's SIO/1:1 and re-instituted 15-minute safety checks. AP/H discontinued C1's Off-Unit privileges and noted C1's need for continued safety assessment within the boundaries of the 7ITC unit.

A hospital Security Report, dated 12/05/16 at 1:30 p.m., indicated an overhead page for "Code Pink" alerted all hospital personnel that a child was missing. The overhead alert included a physical description of C1, who was wearing hospital scrubs and last seen on the way to the swimming pool when C1 ran away from staff toward another building on the tunnel level of the hospital. At 1:38 p.m., a passerby saw C1 outside the hospital on 24th Avenue, off hospital property. At 1:45 p.m., local law enforcement notified hospital security staff that they had custody of C1. At 1:51 p.m., law enforcement brought C1 to the emergency department, where he was medically evaluated with no evidence of injury. At 2:12 p.m., C1 was escorted back to the hospital's child behavioral health unit/Intensive Treatment Center (7ITC).

The progress notes, dated 12/05/16 at 2:47 p.m., indicated that AP/H evaluated C1 after the elopement and noted C1's continued need for assessment of safety on the secure unit with no Off-Unit privileges.

An interview was conducted with Director of Security (DS)/D on 12/13/16 at 10:30 a.m. DS/D stated that the hospital's Code Pink is an immediate alert that all available staff are to help search for a missing child. The procedure to enact Code Pink is for staff to notify the hospital's Security Call Center, who organize the search by collecting information about the missing child and distributing it by radio to Security personnel. The Call Center then announces an overhead page and the hospital's lockdown protocol is enacted. Staff monitor all exits, doors, stairwells, and elevators. Staff search all rooms, restrooms, lounges, stairwells, and corridors. Mobile security staff are dispatched to the cafeteria, bus stops, and the hospital's exterior property. Local law enforcement is notified so they can assist in the search that extends beyond the hospital's property. On 12/05/16 when C1 eloped, C1 was able to exit the hospital ahead of the Code Pink safety traps. A Courier who makes deliveries between the two hospital campuses heard the overhead page for Code Pink and the description of C1. The Courier, who was in his vehicle by the Washington Avenue Bridge, saw C1 and notified the police. The Courier kept his eyes on C1's movement and while waiting for the police to arrive, C1 approached the Courier's vehicle and asked if he could have the Courier's car. The Courier declined C1's request but offered C1 a ride. C1 willingly got in the back seat of the Courier's vehicle where he stayed until the police arrived and assumed custody of him. The police then transported C1 to the hospital's emergency department. C1's elopement from the hospital did not result in any physical harm to C1. C1 was recovered without incident, so the event did not meet the criteria for a root cause analysis. DS/D did not know that C1 was not authorized for Off-Unit privileges on 12/05/16.

The National Weather Service archives indicated that the outside environmental conditions on the day of C1's hospital elopement of 12/05/16 were light rain, 37 degrees, and winds at 18 mph.

An interview was conducted with Psychiatric Associate (PA)/M on 12/13/16 at 10:30 a.m. PA/M stated that she was working on 7ITC on 12/03/16 when C1 attempted suicide and on 12/05/16 when C1 eloped from the hospital. On 12/03/16, C1's level of supervision by staff was 15-minute safety checks. All unit staff share in the responsibility of conducting the safety checks for all patients. During the morning of 12/03/16, C1 was more tearful than normal and left the group movie. C1 paced in and out of his room and around the unit. C1 had lunch in the dining room with other patients around 12:15 p.m. but declined to go to Group activity at 1:00 p.m. C1 wanted to be alone and was isolating himself from others. C1 continued to pace around the unit. At 2:00 p.m., C1 was standing in the doorway to his room. The next safety check wasn't until 2:15 p.m., but PA/M checked on C1 early because he wasn't pacing on the unit as he had been. At 2:11 p.m., PA/M went into C1's room. C1 was laying on his bed. C1 had a sweatshirt stuffed in his mouth and a blanket wrapped around his neck several times. C1 was pulling down on the blanket to asphyxiate himself. C1 was discolored, not blue but also not pink. C1 was still conscious. PA/M told C1 "That is unsafe" and C1 immediately took the sweatshirt out his mouth and removed the blanket from around his neck. C1 stood up from the bed and PA/M asked him to leave his room. PA/M locked C1's room door and escorted him to the lounge where the nurse immediately assessed him. C1 was placed on 1:1 staffing and he was required to change into scrubs and hospital socks. A bean bag chair was placed in the hallway outside of C1's room, after his room was moved near the lounge to increase visibility of him. He was given one quilt that he could use while on the bean bag. His room was stripped of all linens and clothing and he was locked out of the room. Staff did not allow C1 to go Off-Unit all weekend. During the morning of 12/05/16 around 9:30 a.m., staff had a team meeting with AP/H to discuss C1's suicide attempt on 12/03/16. The team decided that it was in C1's best interest to suspend his Off-Unit privileges, monitor him every 15 minutes in the controlled setting of the 7ITC unit, and continue with safety interventions for him to remain in scrubs and hospital socks, locked out of his room across from the lounge. During the morning of 12/05/16, C1 was very fidgety, paced the hallway more, and looked "neurotic." PA/M went to lunch break around 1:00 p.m. and while at lunch, PA/M heard the overhead page for Code Pink that included C1's description and name. PA/M immediately left lunch break and posted at the South exit door. Awhile later, another employee from the unit told PA/M that the Code Pink was cleared, which meant that C1 was found. PA/M then returned to 7ITC. PA/M and several other staff went to the emergency department to escort C1 back to 7ITC. That afternoon C1 was very quiet and withdrawn.

An interview was conducted with RN/L on 12/13/16 at 2:00 p.m. RN/L stated she works for the behavioral health float pool, so she can be assigned to any of the hospital's 14 behavioral health units. On 12/05/16, RN/L was assigned to work on 7ITC, which was the first day she worked with C1. A team meeting of various professionals was convened that morning around 9:00 a.m. to discuss C1's treatment plan after his suicide attempt over the weekend on 12/03/16. AP/H wrote orders revoking C1's Off-Unit privileges because C1 needed to be monitored within the controlled environment of 7ITC. C1 was to be kept in scrubs, visible in the hallway, monitored every 15 minutes, and 1:1 when in the bathroom. During the morning of 12/05/16, C1 was quiet, anxious, and unable to participate in any Group activities all morning, due to his degree of restlessness. In the early afternoon of 12/05/16, RN/L came out of a discharge meeting about another patient and one of the staff told her that C1 went to the swimming pool. Staff are supposed to check with the Charge Nurse before any patient leaves 7ITC. No one checked with RN/L before C1 was taken Off-Unit to the pool. C1 didn't have Off-Unit privileges on 12/05/16. As RN/L was directing another staff to go get C1 from the pool activity, RN/L heard the overhead page for Code Pink that included a description of C1. Numerous staff left the unit to aid in the search of C1. RN/L gave Security personnel a picture of C1. RN/L made a police report. Shortly thereafter, Security personnel advised RN/L that law enforcement found C1, who was in the emergency room. RN/L and several other care givers went to the emergency room to get C1, who was "scared-looking." C1 said he ran because he was "home-sick" and wanted his family. C1 was escorted to 7ITC and RN/L assessed his mental and physical status. C1's condition was unchanged from his morning baseline of restlessness.

An interview was conducted with Recreational Therapist (RT)/Q on 12/13/16 at 12:25 p.m. RT/Q stated she has worked at the hospital for 28 years on units 7A and 7ITC. RT/Q, four other therapists, and unit staff routinely take inpatients Off-Unit for activities, including the swimming pool, the park, and the library. All of these activity areas are hundreds of yards away from where units 7A and 7ITC are located. The staff to patient ratio for an Off-Unit activity is 1:5. Staff are supposed to check with the Charge Nurse before taking a patient Off-Unit for an activity and staff are supposed to take the unit cell phone with them in case an emergency arises. On 12/05/16, RT/Q went to 7ITC around 12:45 p.m. to gather patients to go to the swimming pool. C1 and C8 wanted to go to the pool. C1 enjoyed swimming. RT/Q had taken C1 to the pool previously and C1 followed directions and stayed with the group. On 12/05/16, RT/Q didn't see the Charge Nurse around so RT/Q checked the shift report sheet at the nurse's station which indicated that C1 had Off-Unit privileges. Shortly before 1:00 p.m., RT/Q and PA/O took C1 and C8 Off-Unit to the swimming pool. Neither staff took the unit cell phone along. It's a ten-minute walk from 7ITC to the pool. Staff take the patients through the hospital tunnel to the pool. The tunnel hallway zig-zags in several different directions. When the group had almost reached the pool destination, C1 ran from the group and headed down the zig-zag hallway. RT/Q tried to run after C1 but RT/Q "lost sight" of C1 very quickly. C1 "disappeared" in the hospital tunnel. RT/Q did not have the portable cell phone with her that staff use during an emergency. RT/Q had to find the nearest hospital wall phone to activate Code Pink, the alert for a missing child. RT/Q could not estimate how long it took her to find a hospital wall phone. After the overhead page was announced, RT/Q assisted in the search for C1 until C1 was found by the police. Later that day on 12/05/16, Program Director (PD)/J spoke to RT/Q about C1's elopement and the need for RT/Q to check with the Charge Nurse before taking patients Off-Unit and to make sure RT/Q takes the portable cell phone with her during all activities. Three days later on 12/08/16, RT/Q's supervisor met with her about the circumstances surrounding C1's elopement. RT/Q was reprimanded and was formally re-educated about the policies for Off-Unit activities with patients. This information was verified in RT/Q's personnel file, dated 12/08/16.

Interviews were conducted with AP/H on 12/12/16 at 12:30 p.m. and 12/13/16 at 1:00 p.m. AP/H stated C1 was very ill upon hospital admission. C1 heard screaming in his head, thought an 8-track system was implanted in his body, and had somatic symptoms with complaints that his heart was racing. C1's blood pressure was elevated due to C1's level of anxiety. C1 needed acute mental health care. AP/H conferred with C1's outpatient psychiatrist and parents regarding the inpatient treatment plan, including medication regimen. C1 seemed to respond positively to the treatment plan so on 12/02/16, C1 was granted Off-Unit privileges under staff supervision. Only a physician can authorize a patient's Off-Unit privileges. After C1's suicide attempt on 12/03/16, C1's Off-Unit privileges were revoked. Staff should not have removed C1 from the controlled milieu of 7ITC on 12/05/16. C1 eloped from the hospital during a period when C1 did not have Off-Unit privileges. After C1's elopement, C1 returned to 7ITC unharmed. Treatment goals for residential placement were resumed and C1 was confined to the structured environment of 7ITC. C1's Off-Unit privileges remained suspended through his time of hospital discharge. C1 showed daily improvement and was discharged to a residential treatment program on the morning of 12/12/16.

An interview was conducted with PD/J on 12/12/16 at 10:25 a.m. PD/J stated her responsibilities include direction of patient care and supervision of staff on 7A and 7ITC. Between the two units, PD/J supervises 85 RNs and 80 Psychiatric Associates. PD/J also supervises the behavioral health float pool for nurses, which includes an additional 20 RNs. PD/J stated she was working on 12/05/16 when C1 eloped. After C1 was found and was safely returned to 7ITC, PD/J met with RT/Q on the afternoon of 12/05/16 about RT/Q's failure to follow unit protocol for Off-Unit patient activities with C1 earlier that day. PD/J reviewed the safety protocol for Off-Unit activities with RT/Q and then notified RT/Q's supervisor for further follow-up with RT/Q. PD/J took no other corrective action measures, including evaluating the circumstances of C1's elopement and potential for harm when C1 was without any staff supervision or oversight for 35 minutes, off hospital property in a dangerous situation. PD/J was unaware that PA/O had also accompanied the Off-Unit activity when C1 eloped. PA/O had also failed to ensure that both patients going to the pool on 12/05/16 (C1 and C8) both had Off-Unit privileges on 12/05/16; PA/O had also failed to ensure the portable phone was taken along on the activity. All of the employees working on 7A and 7ITC plus an additional seven therapy staff have the potential to take patients Off-Unit for activities. PD/J didn't think the root cause of C1's elopement was formally investigated because no harm came to C1 and C1 was safely returned to the hospital.

An interview was conducted with several Leadership Staff (LS), including LS/A, LS/B LS/E, LS/F, and LS/G on 12/13/16 at 8:00 a.m. regarding the hospital's investigation and response to C1's elopement on 12/05/16. They stated that C1's elopement from the hospital was regarded as an Occurrence and was documented on an Occurrence Report the same day it occurred. Occurrence Reports are forwarded to the Manager most accountable for the people involved in the occurrence. The responsible Manager is required to review the Occurrence Report within seven days and complete any follow-up within thirty days. C1's Occurrence Report was immediately forwarded to PD/J. On 12/05/16 shortly after C1's elopement occurred, PD/J re-educated RT/Q regarding the safety protocol for Off-Unit patient activities. PD/J's actions were consistent with hospital policy. C1's elopement did not result in harm to C1 so the event did not rise to the level of a Patient Safety Event. Patient harm is the trigger for immediate investigation of an event by root cause analysis to identify systemic failures that may require global corrective action. Potential for patient harm is not a considered factor for root cause analysis of a patient safety event. All five leadership staff acknowledged that the only action taken in response to C1's elopement on 12/05/16 was disciplinary action and re-education of one employee/RT/Q.

An interview was conducted with Family member (FM)/T on 12/15/16 at 1:10 p.m. FM/T stated that C1 struggles with paranoia, hallucinations, and suicidal ideations. C1's mental health issues can escalate quickly and C1 becomes unstable, requiring hospitalization to address his acute decompensation. C1 was hospitalized on 7ITC from 11/29/16 - 12/12/16. FM/T visited C1 frequently and communicated daily with unit staff about concerns FM/T had related to inadequate care and supervision of C1. FM/T stated that insufficient communication between care givers compounded by a lack of proper supervision resulted in C1's ability to elope from the hospital's premises. C1 was picked up by the police off hospital property in a dangerous area of traffic. After police took C1 back to the hospital, C1 remained on 7ITC for another week when staff told FM/T that C1 was stable and ready for discharge to a residential treatment facility. C1 was discharged on 12/12/16 and was transferred to the placement facility on a gurney by medi-van. C1's residential placement lasted three days. C1 fought with the residential staff, tried to run away twice, and was physically restrained. The residential facility notified FM/T that C1 was not appropriate for their program due to C1's unstable behavior and C1 had to be transferred to another hospital emergency room on 12/15/16. FM/T felt that C1 was prematurely discharged from the hospital's child behavioral health unit/Intensive Treatment Center/7ITC on 12/12/15.

The hospital's policy on Occurrence Reporting, revised October 2016, defined an occurrence as a "situation or event that is not consistent with routine patient care or operations of the care setting and resulting in, or with the potential for, injury to a person...occurrences may be the result of system failure, and/or human error, at-risk behavior, or reckless behavior...the managers/supervisors review and investigate occurrence reports routed to their attention to identify: causal or contributing factors, the need for additional information, opportunities for improvement, the need to notify the patient's physician, Risk Management, etc...ordinarily the report should be reviewed within seven days and the manager's follow-up should be completed within thirty days...aggregate data will be analyzed by the appropriate groups, committees, and departments to identify risks and to identify opportunities for prevention and/or improvement.

The hospital's policy Sentinel Event/Patient Safety Event, reviewed March 2015, defined a patient safety event as "an event, incident, or condition that could have resulted, or did result, in harm to a patient...there are several types of patient safety events...No harm event: patient safety event that reaches the patient but does not cause harm...Hazardous (or unsafe) condition: circumstance (other than the patient's own disease process or condition) that increases the probability of an adverse event...Adverse event: a patient safety event that resulted in harm to a patient...Sentinel event: a patient safety event not primarily related to the natural course of the patient's illness or underlying condition that reaches a patient and results in death, permanent harm, intervention required to sustaining life..." The policy indicated that only sentinel events were "subject to a comprehensive systemic analysis to identify causal and contributory factors. Root cause analysis, which focuses on systems and processes is the most frequently used tool for sentinel event analysis...the action plan will be appropriate for the event, will be implemented in a timely manner, and will be monitored for effectiveness."

The hospital's policy on Patient Activities Off a Secure Unit, reviewed March 2016, indicated "the charge nurse will approve all off-unit activities based on the necessity of the activity, patient treatment plan/clinical presentation, and unit staffing. A physician's order for any off-unit activity is required. Staff must take the Unit Phone provided to use for emergencies. The cell phone works just like a unit phone."

The hospital failed to protect patient safety by thoroughly evaluating the circumstances of C1's elopement and the potential for harm that exists when any patient elopes from staff supervision and is able to flee the hospital's property unsupervised, especially during inclement weather. The National Weather Service archives indicated that the outside environmental conditions on 12/12/16 when the State agency investigation began were -2 degrees with light snow and ice. Weather predictions for the week of 12/12/16 included falling temperatures with additional snowfall. On 12/15/16, archived weather conditions were recorded as -8 degrees (daily high) with light snowfall.