The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

NORTHEASTERN VERMONT REGIONAL HOSPITAL 1315 HOSPITAL DRIVE SAINT JOHNSBURY, VT 05819 April 4, 2018
VIOLATION: EMERGENCY SERVICES Tag No: C0200
Based on observation, interview and record review, the CAH (Critical Access Hospital) Emergency Department (ED) failed to provide necessary care and services by qualified and sufficient personnel to ensure the safety and appropriate monitoring for patients identified to be at risk for elopement. Findings include:

Patient #1, a juvenile, was evaluated in the ED on 3/22/18 for behavioral issues, threatening to harm herself/himself with a gesture of attempted strangulation. In lieu of a psychiatric admission, a discharge plan was developed by local community mental health agency staff who had evaluated Patient #1 while in the ED. A treatment/safety plan and outpatient management by the local community mental health agency was developed and Patient #1 was discharged from the ED to home with her/his parent. On 3/26/18 at 19:33 Patient #1 returned to the ED accompanied by a parent per the direction of the local community mental health agency. There had been a failure by Patient #1 to follow the treatment/safety plan initiated on 3/22/18 and the parent was unable to manage and control Patient #1. Upon arrival to the ED on 3/26/18 at approximately 08:00, Patient #1 was agitated and attempted to run from the ED waiting area. Per interview on 4/3/18 at 10:00 AM, the sheriff assigned and stationed in an office in close proximity of the ED waiting area, confirmed that s/he was able to return the patient to the ED with verbal redirection. Patient #1 expressed fear of not being able to return home with parent. A mental health crisis screening was ordered and conducted which determined Patient #1 was in need of treatment and in need of services to include hospitalization or an alternative secure setting. Per ED Physician #1 Visit Note states at 19:50 Patient #1 has "...explosive personality....with mood disruption......security alerted to the situation the patient is at risk of elopement and given recent history in the emergency department aggressive, threatening and violent behavior. I asked him/her to remain on standby outside the emergency department..." Initially a ED nurse was ordered to provide one-to-one observation for Patient #1. At 22:00 ED Physician #1 notes that Patient #1 has verbalized voluntarily treatment and further states "Patient has been fairly cooperative with de-escalation techniques. S/he does intermittently get upset and at one point threatened that s/he was going to hang himself/herself." Because no psychiatric hospital beds were available Patient #1 would remain in the ED until a bed became available.

A Safety Plan was developed on 3/26/18 which included ED nursing staff, ED Physician #1, nursing house supervisor and QMHP (Qualified Mental Health Professional) from the local community mental health agency. Patient #1 was allowed to remain in street clothes and s/he was placed on suicide precautions and under "..direct supervision of nurse, staff or patient observer". Per CAH policy: Subject: Mental Health Patient approved 02/01/17 states: "If patient presents with indications of suicidal tendencies, they will be closely monitored and asked to change into paper scrubs or hospital gown if appropriate."

Per interview on 4/2/18 at 1:30 PM, the ED Nurse Manager confirmed the ED does utilize non-hospital staff to provide patient observations, being only the "eyes and ears". S/he further confirmed the non-hospital staff are not employed by the CAH, and can be volunteers from a local community health agency and frequently augment the CAH staff when one-to-one observations have been ordered by a ED physician. With the exception of the ED nurse who initially provided one-to-one observations for Patient #1's at the time of admission, non-hospital staff were utilized to provide suicide precautions and one-to-one observations for Patient #1. Per interview on 4/2/18 at 1:45 PM, the Vice President for Quality Management Programs further confirmed the non-hospital staff are not employees of the CAH, and are without CAH training, however were assigned on 3/26/18 and 3/27/18 to provide monitoring for the safety of Patient #1. In addition, the Vice President for Quality Management Programs confirmed a policy has not been developed for CAH staff to provide direction and process when conducting the practice of patient observations.

Although fairly quiet most of the early morning of 3/27/18, Patient #1 became agitated when it was brought to the patient's attention by the community human services case worker, s/he would be admitted to a psychiatric hospital. Under the observation of non-hospital staff, Patient #1 attempted to leave assigned room #5 and required redirection by ED staff and eventually became cooperative. Patient #1 requested to use a phone to contact parent. Staff decision was to allow Patient #1 to have the phone and contact was made to parent who happened to be entering the ED through the waiting room. Patient #1, being aware of parent's arrival, ran out from ED room #5 into the waiting room. The parent had arrived with a backpack filled with clothes/items for Patient #1. The parent was re-directed to leave and Patient #1 attempted to run after parent but was physically prevented by sheriff, who put hands on the juvenile and led him/her back inside into the ED waiting room. Per Care Management Progress Note: " Patient started screaming, yelling, swearing. Stating "I'm not going back in that room.....". Minutes later, at 12:08 PM Physician #2 arrived in the ED waiting room to de-escalate the situation involving Patient #1. Per ED Continuation of Care note, ED Physician #2 states: "Patient was verbally redirected by me and walked/escorted back into the emergency department. Shortly after entering the emergency department the patient ran away from his/her one-to-one through the back door, outside the ambulance bay and ran across a parking lot. Sheriffs were enlisted immediately to pursue patient and bring him/her back to the emergency department".

Both the state and local police were alerted of the elopement of the juvenile. Per observation on 4/3/18 at 10:00 AM of close circuit video of the elopement incident which occurred on 3/27/18, Patient #1 was observed returning from the ED waiting room with non-hospital staff who had been assigned to provide one-on-one observations. Patient #1 delays returning to assigned room #5 and turns from room, passes by nurses station and rapidly exits out the ambulance entrance. At that time, Patient #1 was not wearing outer wear, local temperatures in this rural area registered between 34 - 43 degrees F (Fahrenheit). Prior to the elopement, and after the incident in the ED waiting room, ED staff failed to recognize the potential for further elopement attempts by Patient #1. As a result, ED staff failed to develop an emergency safety plan which incorporated immediate interventions; trained and qualified CAH staff to provide appropriate monitoring to ensure the safety of the juvenile, preventing the opportunity for elopement with the risk for potential harm. Subsequently, Patient #1 was found hours later and was returned to the ED on 3/28/17, approximately 28 hours after the elopement, and eventually transferred to a psychiatric hospital.
VIOLATION: STAFFING AND STAFF RESPONSIBLITIES Tag No: C0250
Based on observation, interview and record review, the Condition of Participation: Staff and Staffing Responsibilities was not met as evidenced by the failure of the CAH to ensure sufficient and knowledgeable staff was made available at all times in the Emergency Department to prevent the use of non-hospital staff with the provision of care to include patient observations and to be able to respond to emergent events or procedures.

Refer to C-0253
VIOLATION: SUFFICIENT STAFF Tag No: C0253
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

The CAH failed to ensure sufficient and knowledgeable staff was made available at all times to provide essential services in the Emergency Department to include providing one-to-one observations for 1 applicable patient. (Patient #1) The CAH also failed to ensure sufficient staff coverage was available at all times to provide essential services and able to respond to emergent events or procedures and to be sufficient to meet the needs of all patients for 1 applicable patient. (Patient #2) Findings include:

1. On 3/26/18 at 19:33 Patient #1, a juvenile, was admitted to the ED accompanied by a parent per the direction of the local community mental health agency. A mental health crisis screening was ordered and conducted which determined Patient #1 was in need of treatment and in need of services to include hospitalization or an alternative secure setting. Per ED Physician #1 Visit Note states at 19:50 Patient #1 has "...explosive personality....with mood disruption......security alerted to the situation the patient is at risk of elopement and given recent history in the emergency department aggressive, threatening and violent behavior. I asked him/her to remain on standby outside the emergency department..." Initially a ED nurse was ordered to provide one-to-one observation for Patient #1. At 22:00 ED Physician #1 notes that Patient #1 has verbalized voluntarily treatment and further states "Patient has been fairly cooperative with de-escalation techniques. S/he does intermittently get upset and at one point threatened that s/he was going to hang himself/herself." Because no psychiatric hospital beds were available Patient #1 would remain in the ED until a bed became available.

A Safety Plan was developed on 3/26/18. Patient #1 was allowed to remain in street clothes and s/he was placed on suicide precautions and under "..direct supervision of nurse, staff or patient observer". Per CAH policy: Subject: Mental Health Patient approved 02/01/17 states: "If patient presents with indications of suicidal tendencies, they will be closely monitored......" To assure Patient #1's safety, one-to-one observations were to continue, however qualified and knowledgeable hospital staff was not scheduled or assigned, instead this responsibility was provided by non-hospital staff on 3/26/18 and 3/27/18. Nursing note for 3/27/18 at 07:01 states a call was made to the local community mental health agency seeking a replacement for the present non-hospital staff providing one-to-one observations for Patient #1. It was evident there was a failure to ensure staff coverage was sufficient to provide essential services to include a CAH trained and employed Patient Observer, instead ED staffing was seeking non-hospital staff to meet patient needs.

Under observation by non-hospital staff Patient #1, being aware of his/her parent's arrival to the ED, ran out from room #5 into the ED waiting room. The parent was re-directed to leave the ED waiting room and had exited. However, Patient #1 attempted to run after his/her parent. A sheriff (stationed in office adjacent to the waiting room) responded to the attempted elopement along with non-hospital staff. The sheriff put hands on the juvenile, implementing a brief manual restraint, as s/he was exiting the CAH. The sheriff returned Patient #1 to the ED waiting room.

Per Care Management Progress Note: " Patient started screaming, yelling, swearing. Stating "I'm not going back in that room.....". Minutes later, at 12:08 PM Physician #2 arrived in the ED waiting room to de-escalate the situation involving Patient #1. Per ED Continuation of Care note, ED Physician #2 states: "Patient was verbally redirected by me and walked/escorted back into the emergency department." Despite Patient #1's attempted elopement, trained and qualified CAH staff was not immediately assigned to provide appropriate monitoring to ensure patient safety. Non-hospital staff remained assigned to Patient #1 to provide continued observations, however this plan was ineffective. Shortly after entering the emergency department the patient ran away from his/her one-to-one through the back door, outside the ambulance bay and ran across a parking lot. Subsequently, Patient #1 was found hours later and was returned to the ED on 3/28/17, approximately 28 hours after the elopement, and eventually transferred to a psychiatric hospital.

Per interview on 4/2/18 at 1:30 PM, the ED Nurse Manager confirmed the ED does utilize non-hospital staff to provide patient observations, being only the "eyes and ears". S/he further confirmed the non-hospital staff are not employed by the CAH, and can be volunteers from a local community health agency and frequently augment the CAH staff when one-to-one observations have been ordered by a ED physician.

2. Per record review, Patient #2 was brought to the ED on 12/16/17 at 02:58 by State police for the purpose of being evaluated after the patient requested assistance from the State police. The [AGE] year old arrived intoxicated but not under policy custody. Per ED note: 12/16/17 at 0355: "Pt in handcuffs and being kept in bed by sheriff and VSP. Agitated and not redirectable. S/he will not stay on the stretcher but is extremely unsteady gait and sitting with altered mental status." The State police left and at approximately 03:52 Patient #2 was placed in 4 point restraints (to include all 4 extremities with nylon type restraints) which were discontinued at 0500. Patient #2 was eventually discharged from the ED to home.

The NVRH and Sheriff Security Management Plan last approved on 02/26/18 states the primary security for the CAH is provided by the county sheriff's department who provide 24/7/365 on-site coverage. "Their presence is to deter aggressive behavior and to control a violent patient/person to ensure safety". In ensuring the physical safety of the patient, a staff member, or others, the sheriff may restrain individuals through the use of handcuffs, leg irons which may need to be used prior to the secured subject being put in "hospital restraints". This includes Emergency Evaluation patients trying to leave.....Officers will assist Medical Staff while hospital restraints are applied." The use of law enforcement augmenting CAH staff is also reflected in the policy "Subject: Restraints and Management of a Restraint-Free Environment states: "Emergent situations may arise when law enforcement restraints my have to be used to ensure safety until the availability of hospital restraints option. If this situation does occur, hospital restraints will replace law enforcement restraints as soon as safety permits".

Per interview on 4/3/18 at 10:00 AM, Sheriff #1 assigned to provide security for the CAH confirmed if staff calls for assistance with restraint application s/he would respond, assist and leave when procedure was completed. It was also confirmed, s/he has taken part in training and drills for specific CAH codes to include Code Gray (dealing with a violent person within CAH or a clinic) and Code Pink (infant abduction). The sheriff has received some training from the Department of Mental Health, but no formal training by CAH for the application of various restraints used by CAH staff.

Per interview on 12:50 PM on 4/3/18 the ED Medical Director did confirm "...at times we do not have the resources...". The Medical Director further confirmed the sheriff assigned to the CAH has been utilized to assist staff when applying restraints, noting "...we have used hand cuffs and transitioned to hospital restraints..." This was further confirmed by the ED Nurse manager who stated on 4/2/18 at 1:30 PM, sheriffs often provide a "visual appearance" within the ED when making rounds. In addition, in certain situations the sheriff on duty may be used to apply handcuffs to a patient and eventually assist in the transition to hospital restraints.
VIOLATION: RECORDS SYSTEM Tag No: C0302
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on staff interview, policy review and record review, there was a failure of Emergency Department staff to document continuous observation of patients who were being mechanically restrained, and a failure to document when restraints were discontinued for 1 out of 4 applicable patients in the sample. (Patient #3) Findings include:

Patient #3 was admitted on [DATE] and required a psychiatric evaluation due to increasing symptoms of depression, anxiety and paranoia. According to the Emergency Department Continuation of Care physician progress note from 1/24/2018, Patient #3 experienced an increase in paranoia overnight, and an "inability to differentiate between real and unreal" while becoming more paranoid. Per MD note, insight and judgement had deteriorated, and s/he felt Patient #3 was unable to care for herself/himself, make decisions and was unsafe. Per RN note, Patient #3 became increasingly agitated and became physically aggressive, pushing family members present in the room for support and attempted to elope from the ED. Mechanical restraints were initiated due to Patient #3's risk of harm to self amd others. Per review of the medical record, there were no nursing notes to reflect continuous observation had been implemented by a competent staff member during the duration of the restraint, which was initiated at 13:00 and discontinued at 15:00. Per hospital procedure, Restraint Application and Monitoring, "the patient restrained for violent or self-destructive behavior must be continuously monitored by a competent staff member. The patient should be assessed for: signs of injury associated with restraint application, nutrition and hydration needs, circulation and ROM, hygiene and elimination, physical and psychological status and comfort, and readiness for the discontinuation of the restraint."

The lack of documentation in the medical record reflecting the continual monitoring and assessment of Patient #3 during the implementation of restraints was confirmed with the Clinical Informatics Specialist on 4/4/2018 at 10:30 AM.
VIOLATION: RECORDS SYSTEM Tag No: C0306
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on staff interview and record review, there was a failure of Emergency Department physicians to document orders for restraints and orders for crisis screening for 3 of 10 patients in the sample. (Patients #1, 3, 4) Findings include:

1. Patient #3 was admitted on [DATE] and required a psychiatric evaluation due to increasing symptoms of [DIAGNOSES REDACTED].

Per review of the medical record, an order for Restraints was written by the Emergency Department physician on 1/24/2018 at 0738 AM. The duration of the restraint per physician order was for four hours. However, the restraint was not implemented until 1:00 PM. Per physician progress note dated 1/24/2018 at 0830, "...physical restraints have been ordered but have not yet been used". Per order criteria listed in the Electronic Medical Record, "the order must be obtained prior to or immediately after application of restraints". The hospital policy, Restraints and Management of Restraint Free Environment: restraint application and monitoring states, "Orders for seclusion or restraint applied to manage violent or self-destructive behavior shall remain in effect until the patient's behavior or situation is assessed to no longer require seclusion or restraint, but no longer than 4 hours for adults 18 years or older." During an interview, the Emergency Department Medical Director was informed of the time the restraint order was written for Patient #3 and when the restraint was implemented. The Emergency Department Medical Director stated his/her expectation that orders for restraints were obtained at the time the intervention was clinically indicated, or immediately after the restraints had been applied. The lack of an accurate order for Patient #3's restraints was confirmed with the Clinical Informatics Specialist on 4/4/2018 at 10:30 AM.

2. Patient #4 was admitted on [DATE] with abdominal pain and hypotension and was diagnosed with [DIAGNOSES REDACTED]. S/he required intubation to facilitate further diagnostic studies. Following a change in mental status and physical behavior assessed to be harmful to themselves, per nursing progress note, restraints were implemented at 3:00 PM and removed at 3:35 PM. However, there was no evidence of a physician order in the medical record for the restraints. The lack of an order for the restraints implemented with Patient #4 was confirmed with the Clinical Informatics Specialist on 4/4/2018 at 10:30 AM.

3. On 3/26/18 at 19:33 Patient #1 arrived in the ED, accompanied by his/her patient, as per the direction of the local community mental health agency for the purpose of Patient #1 being evaluated for a possible psychiatric admission. A mental health crisis screening was conducted which determined Patient #1 was in need of treatment and in need of services to include hospitalization or an alternative secure setting. Per review of the ED record and confirmed by the Manager for Medical Records Department, the ED physician failed to write an order for a mental health screening to be conducted.
VIOLATION: PERIODIC EVALUATION & QA REVIEW Tag No: C0330
Based on observation, interview and record review, the Condition of Participation: Periodic Evaluation and Quality Assurance Review was not met as evidenced by the CAH failed to ensure that an effective quality assurance program was in place to evaluate the quality and appropriateness of treatment and services furnished in the Emergency Department.

Refer to C-0336
VIOLATION: QA - QUALITY OF PATIENT CARE Tag No: C0336
Per staff interview, medical record review and hospital documentation review, the Emergency Department medical and nursing staff failed to utilize the established Risk Management Reporting System to report the Adverse Event of an elopement; an event which had the potential to result in patient harm for 1 of 10 applicable patients. (Patient #1) Findings include:

1. On 3/26/18 at 19:33 Patient #1 returned to the ED accompanied by a parent per the direction of the local community mental health agency. There had been a failure by Patient #1 to follow the treatment/safety plan initiated on 3/22/18 and the parent was unable to manage and control Patient #1. A mental health crisis screening was ordered and conducted which determined Patient #1 was in need of treatment and in need of services to include hospitalization or an alternative secure setting. Per ED Physician #1 Visit Note states at 19:50 Patient #1 has "...explosive personality....with mood disruption......security alerted to the situation the patient is at risk of elopement and given recent history in the emergency department aggressive, threatening and violent behavior. Because no psychiatric hospital beds were available Patient #1 would remain in the ED until a bed became available.

Although fairly quiet most of the early morning of 3/27/18, Patient #1 became agitated when it was brought to the patient's attention by the community human services case worker, s/he would be admitted to a psychiatric hospital. Under the observation of non-hospital staff, Patient #1 attempted to leave assigned room #5 and required redirection by ED staff and eventually became cooperative. Patient #1 requested to use a phone to contact parent. Staff decision was to allow Patient #1 to have the phone and contact was made to parent who happened to be entering the ED through the waiting room. Patient #1, being aware of parent's arrival, ran out from ED room #5 into the waiting room. The parent had arrived with a backpack filled with clothes/items for Patient #1. The parent was re-directed to leave and Patient #1 attempted to run after parent but was physically prevented by sheriff, who put hands on the juvenile and led him/her back inside into the ED waiting room. Minutes later, at 12:08 PM Physician #2 arrived in the ED waiting room to de-escalate the situation involving Patient #1. Per ED Continuation of Care note, ED Physician #2 states: "Patient was verbally redirected by me and walked/escorted back into the emergency department. Shortly after entering the emergency department the patient ran away from his/her one-to-one through the back door, outside the ambulance bay and ran across a parking lot. Sheriffs were enlisted immediately to pursue patient and bring him/her back to the emergency department". Both the state and local police were alerted of the elopement of the juvenile. At that time, Patient #1 was not wearing outer wear, local temperatures in this rural area registered between 34 - 43 degrees F (Fahrenheit). Subsequently, Patient #1 was found hours later and was returned to the ED on 3/28/17, approximately 28 hours after the elopement, and eventually transferred to a psychiatric hospital.

The hospital's, Adverse Event and Near Miss Reporting Policy states under the heading Reporting an Adverse Event or Near Miss that, "as soon as an adverse event occurs, or a non-medication near miss is discovered, it should be reported in the Meditech Risk Management System. Reporting adverse events helps us to improve safety in patient care and to create a safe work environment for employees, patients, visitors alike."

During an interview on 4/2/2018 at 1:45 PM, the Vice President of Quality Management confirmed there was no evidence that medical or nursing staff entered a report of the elopement of Patient #1 into the Risk Management System for review. Per the Adverse Event and Near Miss Reporting Policy, "....the staff member most closely involved in the event should enter the data in the Meditech System". During an interview on 4/3/2018 at 09:00 with the Nurse assigned to care for Patient #1 on the day of the elopement, s/he stated that they were familiar with the event reporting system but had not completed an incident report regarding this elopement. During an interview on 4/3/2018 at 12:40 PM, the Emergency Department Medical Director indicated s/he had been notified of the elopement by phone but had not had an event report referred to him/her for review by the Quality Department or other hospital manager. The Emergency Department Medical Director described the elopement as, "an adverse event which was significant". The Nurse Manager of the Emergency Department stated in an interview on 4/2/2018 at 1:45 PM that there was not an Adverse Event form related to this elopement and that, "we will have a debrief". While the elopement of Patient #1 had occurred on 3/27/2018, there was no evidence of an initiation of a review at the time of the investigation. Per Adverse Event and Near Miss Reporting Policy, "the investigation should be started within two working days ...the department manager shall be responsible for timely follow up as needed and to refer the incident to the leader of any other department that may have necessary information or who may be involved in the occurrence."

The failure to report the elopement created a missed opportunity for the hospital to investigate, evaluate, and identify corrective actions related to patient safety and the appropriateness of treatment interventions and outcomes in the Emergency Department.