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Based on observation, interview, and document review, the hospital failed to ensure patients rights to be free from unnecessary restraints, care in a safe setting, personal privacy, and participation in the plan of care for patients who was admitted through the hospital's Emergency Department (ED) for mental health treatment. Patients were coerced, and/or restrained, and stripped out of their clothes and forced into hospital scrubs by hospital staff. This practice of forcing patients out of their clothes and into scrub tops and pants was an ongoing practice for patients presenting to the emergency room for Mental Health Conditions. This resulted in an Immediate Jeopardy to the health and safety of all Mental Health patients admitted through the Emergency Department.

The immediate jeopardy began on 2/25/2018, when a patient declined to change into orange scrubs before her assessment in the Emergency Department and staff restrained the patient in order to change her clothes, stripped her clothes off and forced her into scrubs. Several staff initiated incident reports related to the incident to hospital leadership.

The hospital's leadership staff: President, Chief Nursing officer, Director of Regulatory and Compliance, Director of Critical Care, and the Emergency Department West Manager, were notified of the immediate jeopardy on 5/21/2018, at 3:40 p.m.

The immediate jeopardy was removed on 5/23/2018, at 1:15 p.m., when an acceptable removal plan was implemented to protect the health and safety of patients. Including changing the procedures around Mental Health patient admission to the ED, discontinuing the practice of forcing patients to change into orange scrubs against their will and training all staff on the new procedures.

Based on observation, interview and document review, the hospital failed to ensure each patients right to participate in his or her plan of care for 3 of 20 records reviewed, P1, P3, and P5 when staff members coerced or forced mental health patients presenting to the Emergency Department (ED ) into changing into "behavioral" orange scrub tops and bottoms. See A130.

Based on interview and document and video review, the hospital failed to ensure the patients right to personal privacy for 1 of 20 patients reviewed, P1, when hospital staff restrained, stripped and changed the patient into orange hospital scrubs against her will. The process included up to 12 staff members, including male staff. See A143.

Based on interview, document review and video observation, the hospital failed to provide care in a safe setting for 3 of 20 patients reviewed, P1, P3 and P5 who presented to the hospital's Emergency Department (ED) for Mental Health Services and the patients were forced, against their will to change out of their clothes and into orange hospital scrubs. This forced procedure included a staff "show of force" or restraining and stripping the patient's clothes off in some cases. See A144.

Based on observation, interview, document review and video review, the hospital failed to ensure a patients right to be free of restraints or seclusion used as a means of coercion or staff convenience for 1 of 20 patients reviewed, P1, when she presented to the Emergency Department (ED) for Mental Health concerns, and staff members restrained her, stripped off her clothes and forced her into orange hospital scrubs against her will. The hospital used the orange scrubs as a quick method to identify Mental Health patients in the ED. See A154.

The hospital's failure to ensure Patient Rights resulted in the hospital's inability to meet the Condition of Participation of Patients Rights at 42 CFR 482.13.

Based on observation, interview, video review and document review, the hospital failed to ensure each patients right to participate in his or her plan of care for 3 of 20 records reviewed, P1, P3, and P5 when staff members coerced or forced mental health patients presenting to the Emergency Department (ED ) into changing into orange scrub tops and bottoms against their will when the patients declined, regardless of their diagnoses and at times, prior to assessment by a physician. P1 was restrained, and her clothes forcibly removed against her will, P3 was coerced to change into orange hospital scrubs against her will by a staff show of force, and P5 was coerced to change into orange hospital scrubs against her will through a staff show of force. Finding include:

P1:
A review of P1's medical record revealed P1 presented to the hospital through the ED on 2/25/2018 at 1:22 p.m. P1 came to the emergency room via a car.

P1's history and physical dated 2/25/2018 revealed She had a history of Anxiety, depression, Psychosis, Polysubstance abuse and Post Traumatic Stress Disorder. P1's history included rape.

P1 psychiatric evaluation on 2/25/2-18 revealed her behavior was normal.

The medical record section dated 2/25/2018 titled ED course revealed: "She refused her vital signs but appeared in no emotional distress. She was paranoid, and at times appeared to respond to internal stimuli. She made numerous delusional statements, alleging hospital staff were trying to persecute her or harm her or harm her baby (the patient does not have a baby.) The patient refused to be searched or to go into the room and ultimately a code 21 was called and the patient required physical restraint and treatment of psychosis with Zyprexa." There was no evidence in the medical record that P1 was violent, or indicated she was in imminent danger to hurt herself or anyone else.

Investigators reviewed the video recording that captured the time P1 entered exam room #12 at 1:25 p.m. on 02/25/18, until P1 was situated in seclusion room #14 at 2:05 p.m. on 02/25/18. Exam Room #12 is a designated mental health room. The video does not have audio. Multiple staff appear to be verbally interacting with P1 throughout the video. The video shows: At 1:25 p.m., P1 walked into exam room #12 cooperatively, removed her shoes, and sat on the bed. A nurse then entered room #12, carrying orange scrubs for P1. P1 cooperated with the nurse at the bedside. P1 then objected to relinquishing her personal items to staff and made a hand gesture at the nurse when this was requested. The physician entered the room and talked to P1, who was crying. At 1:35 p.m., P1 stood up from the bed and made animated hand gestures to the physician. The physician and two other staff positioned themselves in the doorway, blocking it. Two security staff arrived and positioned themselves in the doorway with the other staff, at which time P1 voluntarily walked to the chair in the exam room and sat down in the chair. At 1:40 p.m., P1 remained seated in the chair, cooperative and not violent or aggressive. P1 then refused to relinquish her coat to staff. A Code 21 was enacted. Additional staff arrived. At 1:45 p.m., seven staff were present in P1's room during which time P1 remained seated calmly in the chair with no threats of physical violence. At 1:46 p.m., the physician re-entered P1's room along with six other staff; several additional staff readied seclusion room #14 for P1. At 1:50 p.m., multiple staff formed a human wall in front of P1, who was still seated calmly in the chair in exam room #12. In a unified force, staff removed P1 from the chair to the floor, face-down, and restrained P1 from all sides including laying across P1's torso/lower extremities. P1 was motionless. Staff then placed P1 on a backboard and carried P1 to seclusion room #14. Thirteen staff were in seclusion room #14 with P1, including the physician. The door to seclusion room #14 was left wide open while eleven staff held P1 down and removed her clothes. At 2:01 p.m., P1 began to physically fight the staff as they unclothed her. Staff placed a blanket over P1's legs when it became apparent P1 was not wearing any under garments. A nurse holding a syringe was waiting by the doorway. After staff dressed P1 in orange scrubs, staff pulled P1 onto mat, face-down. The nurse gave P1 an injection. Staff wrapped P1's legs with a canvas binder. At 2:05 p.m., all staff left P1's room. P1 was in a prone position on the mat with her legs bound.

P3:
Medical record review revealed P3 was admitted to the hospital through the ED on 5/20/2018 at 10:25 p.m. related to Suicidal Ideation and Bipolar Disorder.

A nursing note, dated 5/20/2018 at 10:45 p.m. revealed "Patient required code Green to get into scrubs."

There was no evidence in the record that P3 was violent, self-injurious or threatening to staff in any way prior to the "Show of Force" code green was called.

P5:
Medical record review revealed P5 was admitted to the hospital through the ED on 5/18/2018 at 1:32 p.m. P5 presented to the ED via ambulance after she left a suicide note at school which included a suicide plan to use carbon monoxide to kill herself. There was no evidence in the medical record that P5 had been violent, imminently self-injurious or had current access to a method to harm herself.

Observations of P5 on 5/18/2018 at 1:45 p.m. revealed P5 was declining to change into the hospital orange scrubs. A code 21 was called and numerous hospital staff responded to the ED in a "show of force" which included 9 individuals including ED, Mental Health and Security staff. P5 was observed to see the numerous staff who responded to the Code 21 overhead page and walked into the bathroom to change into the scrubs. Security staff was observed to watch P5 in the bathroom changing into the scrubs through the door.

During an interview on 5/18/2018 at 1:45 p.m. RN-I confirmed that the Code 21 "Show of Force" was called because P5 declined to change into scrubs.

During an interview on 5/18/2018 at 8:15 a.m., RN-E stated there are times when a patient is forced into scrubs before being seen by a medical provider. RN-E stated she was not aware if there were any instances in which the patient was not violent, but became violent as a result of being forced into scrubs in the ED.

Six psychiatric associates/PAs (PA/CC, PA/DD, PA/EE, PA/FF, PA/GG, and PA/HH) who work on adult inpatient mental health units were interviewed on 05/22/18. All six psychiatric associates stated they are routinely assigned to the Code 21 team that responds to patient behavioral incidents throughout the hospital. Approximately one-third to one-half of the Code 21 incidents occur in the ED, requiring their response assistance at least once a shift and sometimes up to three times a shift. When they arrive on the incident scene in ED, ED staff and Security staff are already there with the patient constituting a group of about six to eight staff. After inpatient mental health staff arrive as part of the "show of force" to get the patient to comply, approximately eleven or twelve staff surround the patient. Security staff often already have the patient on the floor. Most of the time, the patient is refusing to change into orange scrubs, per policy for all mental health patients in the ED; orange scrubs are a quick identifier of patients with mental health or behavioral issues. If a patient continues to refuse to change into the scrubs after a show of force, a group of eight to ten staff restrain the patient, remove the patient's clothes, and dress the patient in scrubs.

Three registered nurses who work in the ED (RN/Z, RN/AA, and RN/BB) were interviewed on 05/22/18 and confirmed that orange scrubs serve as the "visual" to identify ED patients with mental health or chemical dependency issues; orange scrubs signify the patient has been searched and should not be out of their room, unattended.

The document titled Memo, dated April 19, 2018 and provided by hospital staff revealed:

Expectations of responding to a Code Green/Code 21 Team and ED staff: In order to improve service to patients that seek care at the West Bank ED for their mental illness or chemical dependence, standard expectations are being set for ED staff and the responding Code 21/green team. This will allow for enhanced collaboration between the responding Code 21/green team and ED staff. Attached to the memo are the ED search Guidelines.

1. All Behavioral Health/Chemical Dependency (BH/CD) patients that arrive in the ED MUST have a safety screen completed. The search is necessary to keep the patient and staff safe. This is different from the standard on the BH units.

2. A Code Green or Code 21 may be necessary if a patient refuses to be searched or change into scrubs...

6. The patient will then be searched and changed into scrubs. The RN will direct the team if restraints/seclusion is required.

This document has no notation of an initiate date, or approval by any hospital governing body or committee.

The Hospital Policy titled restraint or Seclusion , dated 6/17/2018 and provided by hospital staff and approved by the hospital Clinical Quality and Policy Group was reveiewed.

Under Philosophy: Fairview Health Services recognized the unique needs associated with the care of the patient whose actions pose a safety risk to self or others. The use of restraint or seclusion poses an inherent risk to the physical safety and the psychological well-being of the patient and staff. Therefore:

I. Fairview Health Services will strive to prevent, reduce and when possible eliminate the use of restraint and seclusion. The safety of the patient, staff or others is the basis for initiating or discontinuing the use of restraint or seclusion.

II. Least Restrictive alternatives/interventions and environment are the first choice unless safety issues demand an immediate physical response.

III. When restraint or seclusion is used, particular attention is given to preserving the patient's safety and dignity; these interventions are discontinued at the earliest time possible.

IV. The use of restraint or seclusion for coercion, discipline convenience or retaliation by staff is not permitted.

V. Restraint or seclusion for violent/self-destructive behavior is used only in an emergency, when there is imminent risk of a patient physically harming self, a staff member or others.

Based on interview and document and video review, the hospital failed to ensure the patients right to personal privacy for 1 of 20 patients reviewed, P1, when hospital staff restrained, stripped her clothes off and changed the patient into orange hospital scrubs against her will. The process included up to thirteen staff members, including male staff. Findings inclue:

A review of P1's medical record revealed P1 presented to the hospital through the ED on 2/25/2018 at 1:22 p.m. P1 came to the emergency room via a car.

P1's history and physical dated 2/25/2018 revealed She had a history of Anxiety, depression, Psychosis, Polysubstance abuse and Post Traumatic Stress Disorder. P1's history included rape.

P1 psychiatric evaluation dated 2/25/2018 revealed her behavior was normal.

The medical record section dated 2/25/2018 titled ED course revealed: "She refused her vital signs but appeared in no emotional distress. She was paranoid, and at times appeared to respond to internal stimuli. She made numerous delusional statements, alleging hospital staff were trying to persecute her or harm her or harm her baby (the patient does not have a baby.) The patient refused to be searched or to go into the room and ultimately a code 21 was called and the patient required physical restraint and treatment of psychosis with Zyprexa." There was no evidence in the medical record that P1 was violent, or indicated she was in imminent danger to hurt herself or anyone else.

Investigators reviewed the video recording that captured the time P1 entered exam room #12 at 1:25 p.m. on 02/25/18, until P1 was situated in seclusion room #14 at 2:05 p.m. on 02/25/18. Exam Room #12 is a designated mental health room. The video does not have audio. Multiple staff appear to be verbally interacting with P1 throughout the video. The video shows: At 1:25 p.m., P1 walked into exam room #12 cooperatively, removed her shoes, and sat on the bed. A nurse then entered room #12, carrying orange scrubs for P1. P1 cooperated with the nurse at the bedside. P1 then objected to relinquishing her personal items to staff and made a hand gesture at the nurse when this was requested. The physician entered the room and talked to P1, who was crying. At 1:35 p.m., P1 stood up from the bed and made animated hand gestures to the physician. The physician and two other staff positioned themselves in the doorway, blocking it. Two security staff arrived and positioned themselves in the doorway with the other staff, at which time P1 voluntarily walked to the chair in the exam room and sat down in the chair. At 1:40 p.m., P1 remained seated in the chair, cooperative and not violent or aggressive. P1 then refused to relinquish her coat to staff. A Code 21 was enacted. Additional staff arrived. At 1:45 p.m., seven staff were present in P1's room during which time P1 remained seated calmly in the chair with no threats of physical violence. At 1:46 p.m., the physician re-entered P1's room along with six other staff; several additional staff readied seclusion room #14 for P1. At 1:50 p.m., multiple staff formed a human wall in front of P1, who was still seated calmly in the chair in exam room #12. In a unified force, staff removed P1 from the chair to the floor, face-down, and restrained P1 from all sides including laying across P1's torso/lower extremities. P1 was motionless. Staff then placed P1 on a backboard and carried P1 to seclusion room #14. Thirteen staff were in seclusion room #14 with P1, including the physician. The door to seclusion room #14 was left wide open while eleven staff held P1 down and removed her clothes. At 2:01 p.m., P1 began to physically fight the staff as they unclothed her. Staff placed a blanket over P1's legs when it became apparent P1 was not wearing any under garments. A nurse holding a syringe was waiting by the doorway. After staff dressed P1 in orange scrubs, staff pulled P1 onto mat, face-down. The nurse gave P1 an injection. Staff wrapped P1's legs with a canvas binder. At 2:05 p.m., all staff left P1's room. P1 was in a prone position on the mat with her legs bound.

The Hospital Policy titled restraint or Seclusion , dated 6/17/2018 and provided by hospital staff and approved by the hospital Clinical Quality and Policy Group was reveiewed.

Under Philosophy: Fairview Health Services recognized the unique needs associated with the care of the patient whose actions pose a safety risk to self or others. The use of restraint or seclusion poses an inherent risk to the physical safety and the psychological well-being of the patient and staff. Therefore:

I. Fairview Health Services will strive to prevent, reduce and when possible eliminate the use of restraint and seclusion. The safety of the patient, staff or others is the basis for initiating or discontinuing the use of restraint or seclusion.

II. Least Restrictive alternatives/interventions and environment are the first choice unless safety issues demand an immediate physical response.

III. When restraint or seclusion is used, particular attention is given to preserving the patient's safety and dignity; these interventions are discontinued at the earliest time possible.

Based on interview, document review and video observation, the hospital failed to provide care in a safe setting for 3 of 20 patients reviewed, P1, P3, and P5 who presented to the hospital's Emergency Department (ED) for Mental Health Services and the patients were forced, against their will to change out of their clothes and into orange hospital scrubs. P1 was restrained, and her clothes forcibly removed against her will, P3 was coerced to change into orange hospital scrubs against her will by a staff show of force, and P5 was coerced to change into orange hospital scrubs against her will through a staff show of force. Finding include:Fidings iclude:

P1:
A review of P1's medical record revealed P1 presented to the hospital through the ED on 2/25/2018 at 1:22 p.m. P1 came to the emergency room via a car.

P1's history and physical dated 2/25/2018 revealed She had a history of Anxiety, depression, Psychosis, Polysubstance abuse and Post Traumatic Stress Disorder. P1's history included rape.

P1 psychiatric evaluation on 2/25/2-18 revealed her behavior was normal.

The medical record section dated 2/25/2018 titled ED course revealed: "She refused her vital signs but appeared in no emotional distress. She was paranoid, and at times appeared to respond to internal stimuli. She made numerous delusional statements, alleging hospital staff were trying to persecute her or harm her or harm her baby (the patient does not have a baby.) The patient refused to be searched or to go into the room and ultimately a code 21 was called and the patient required physical restraint and treatment of psychosis with Zyprexa." There was no evidence in the medical record that P1 was violent, or indicated she was in imminent danger to hurt herself or anyone else.

Investigators reviewed the video recording that captured the time P1 entered exam room #12 at 1:25 p.m. on 02/25/18, until P1 was situated in seclusion room #14 at 2:05 p.m. on 02/25/18. Exam Room #12 is a designated mental health room. The video does not have audio. Multiple staff appear to be verbally interacting with P1 throughout the video. The video shows: At 1:25 p.m., P1 walked into exam room #12 cooperatively, removed her shoes, and sat on the bed. A nurse then entered room #12, carrying orange scrubs for P1. P1 cooperated with the nurse at the bedside. P1 then objected to relinquishing her personal items to staff and made a hand gesture at the nurse when this was requested. The physician entered the room and talked to P1, who was crying. At 1:35 p.m., P1 stood up from the bed and made animated hand gestures to the physician. The physician and two other staff positioned themselves in the doorway, blocking it. Two security staff arrived and positioned themselves in the doorway with the other staff, at which time P1 voluntarily walked to the chair in the exam room and sat down in the chair. At 1:40 p.m., P1 remained seated in the chair, cooperative and not violent or aggressive. P1 then refused to relinquish her coat to staff. A Code 21 was enacted. Additional staff arrived. At 1:45 p.m., seven staff were present in P1's room during which time P1 remained seated calmly in the chair with no threats of physical violence. At 1:46 p.m., the physician re-entered P1's room along with six other staff; several additional staff readied seclusion room #14 for P1. At 1:50 p.m., multiple staff formed a human wall in front of P1, who was still seated calmly in the chair in exam room #12. In a unified force, staff removed P1 from the chair to the floor, face-down, and restrained P1 from all sides including laying across P1's torso/lower extremities. P1 was motionless. Staff then placed P1 on a backboard and carried P1 to seclusion room #14. Thirteen staff were in seclusion room #14 with P1, including the physician. The door to seclusion room #14 was left wide open while eleven staff held P1 down and removed her clothes. At 2:01 p.m., P1 began to physically fight the staff as they unclothed her. Staff placed a blanket over P1's legs when it became apparent P1 was not wearing any under garments. A nurse holding a syringe was waiting by the doorway. After staff dressed P1 in orange scrubs, staff pulled P1 onto mat, face-down. The nurse gave P1 an injection. Staff wrapped P1's legs with a canvas binder. At 2:05 p.m., all staff left P1's room. P1 was in a prone position on the mat with her legs bound.

P3:
Medical record review revealed P3 was admitted to the hospital through the ED on 5/20/2018 at 10:25 p.m. related to Suicidal Ideation and Bipolar Disorder.

A nursing note, dated 5/20/2018 at 10:45 p.m. revealed "Patient required code Green to get into scrubs."

There was no evidence in the record that P3 was violent, self-injurious or threatening to staff in any way prior to the "Show of Force" code green was called.

P5:
Medical record review revealed P5 was admitted to the hospital through the ED on 5/18/2018 at 1:32 p.m. P5 presented to the ED via ambulance after she left a suicide note at school which included a suicide plan to use carbon monoxide to kill herself. There was no evidence in the medical record that P5 had been violent, imminently self-injurious or had current access to a method to harm herself.

Observations of P5 on 5/18/2018 at 1:45 p.m. revealed P5 was declining to change into the hospital orange scrubs. A code 21 was called and numerous hospital staff responded to the ED in a "show of force" which included 9 individuals including ED, Mental Health and Security staff. P5 was observed to see the numerous staff who responded to the Code 21 overhead page and walked into the bathroom to change into the scrubs. Security staff was observed to watch P5 in the bathroom changing into the scrubs through the door.

During an interview on 5/18/2018 at 1:45 p.m. RN-I confirmed that the Code 21 "Show of Force" was called because P5 declined to change into scrubs.

During an interview on 5/18/2018 at 8:15 a.m., RN-E stated there are times when a patient is forced into scrubs before being seen by a medical provider. RN-E stated she was not aware if there were any instances in which the patient was not violent, but became violent as a result of being forced into scrubs in the ED.

Six psychiatric associates/PAs (PA/CC, PA/DD, PA/EE, PA/FF, PA/GG, and PA/HH) who work on adult inpatient mental health units were interviewed on 05/22/18. All six psychiatric associates stated they are routinely assigned to the Code 21 team that responds to patient behavioral incidents throughout the hospital. Approximately one-third to one-half of the Code 21 incidents occur in the ED, requiring their response assistance at least once a shift and sometimes up to three times a shift. When they arrive on the incident scene in ED, ED staff and Security staff are already there with the patient constituting a group of about six to eight staff. After inpatient mental health staff arrive as part of the "show of force" to get the patient to comply, approximately eleven or twelve staff surround the patient. Security staff often already have the patient on the floor. Most of the time, the patient is refusing to change into orange scrubs, per policy for all mental health patients in the ED; orange scrubs are a quick identifier of patients with mental health or behavioral issues. If a patient continues to refuse to change into the scrubs after a show of force, a group of eight to ten staff restrain the patient, remove the patient's clothes, and dress the patient in scrubs.

Three registered nurses who work in the ED (RN/Z, RN/AA, and RN/BB) were interviewed on 05/22/18 and confirmed that orange scrubs serve as the "visual" to identify ED patients with mental health or chemical dependency issues; orange scrubs signify the patient has been searched and should not be out of their room, unattended.

The document titled Memo, dated April 19, 2018 and provided by hospital staff revealed:

Expectations of responding to a Code Green/Code 21 Team and ED staff: In order to improve service to patients that seek care at the West Bank ED for their mental illness or chemical dependence, standard expectations are being set for ED staff and the responding Code 21/green team. This will allow for enhanced collaboration between the responding Code 21/green team and ED staff. Attached to the memo are the ED search Guidelines.

1. All Behavioral Health/Chemical Dependency (BH/CD) patients that arrive in the ED MUST have a safety screen completed. The search is necessary to keep the patient and staff safe. This is different from the standard on the BH units.

2. A Code Green or Code 21 may be necessary if a patient refuses to be searched or change into scrubs...

6. The patient will then be searched and changed into scrubs. The RN will direct the team if restraints/seclusion is required.

This document has no notation of an initiate date, or approval by any hospital governing body or committee.

The Hospital Policy titled restraint or Seclusion , dated 6/17/2018 and provided by hospital staff and approved by the hospital Clinical Quality and Policy Group was reveiewed.

Under Philosophy: Fairview Health Services recognized the unique needs associated with the care of the patient whose actions pose a safety risk to self or others. The use of restraint or seclusion poses an inherent risk to the physical safety and the psychological well-being of the patient and staff. Therefore:

I. Fairview Health Services will strive to prevent, reduce and when possible eliminate the use of restraint and seclusion. The safety of the patient, staff or others is the basis for initiating or discontinuing the use of restraint or seclusion.

II. Least Restrictive alternatives/interventions and environment are the first choice unless safety issues demand an immediate physical response.

III. When restraint or seclusion is used, particular attention is given to preserving the patient's safety and dignity; these interventions are discontinued at the earliest time possible.

IV. The use of restraint or seclusion for coercion, discipline convenience or retaliation by staff is not permitted.

V. Restraint or seclusion for violent/self-destructive behavior is used only in an emergency, when there is imminent risk of a patient physically harming self, a staff member or others.

Based on observation, interview, document review and video review, the hospital failed to ensure a patient's right to be free of restraints or seclusion used as a means of coercion or staff convenience for 1 of 20 patients reviewed, P1, when P1 presented to the Emergency Department (ED) for Mental Health concerns, and staff restrained P1 against her will because she declined to change into orange hospital scrubs. There was no evidence in the medical record that P1 was violent, or indicated she was in imminent danger to hurt herself or anyone else. Finding include:

A review of P1's medical record revealed P1 presented to the hospital through the ED on 2/25/2018 at 1:22 p.m. P1 came to the emergency room via a car.

P1's history and physical dated 2/25/2018 revealed She had a history of Anxiety, depression, Psychosis, Polysubstance abuse and Post Traumatic Stress Disorder. P1's history included rape.

P1 psychiatric evaluation on 2/25/2-18 revealed her behavior was normal.

The medical record section dated 2/25/2018 titled ED course revealed: "She refused her vital signs but appeared in no emotional distress. She was paranoid, and at times appeared to respond to internal stimuli. She made numerous delusional statements, alleging hospital staff were trying to persecute her or harm her or harm her baby (the patient does not have a baby.) The patient refused to be searched or to go into the room and ultimately a code 21 was called and the patient required physical restraint and treatment of psychosis with Zyprexa." There was no evidence in the medical record that P1 was violent, or indicated she was in imminent danger to hurt herself or anyone else.

Investigators reviewed the video recording that captured the time P1 entered exam room #12 at 1:25 p.m. on 02/25/18, until P1 was situated in seclusion room #14 at 2:05 p.m. on 02/25/18. Exam Room #12 is a designated mental health room. The video does not have audio. Multiple staff appear to be verbally interacting with P1 throughout the video. The video shows: At 1:25 p.m., P1 walked into exam room #12 cooperatively, removed her shoes, and sat on the bed. A nurse then entered room #12, carrying orange scrubs for P1. P1 cooperated with the nurse at the bedside. P1 then objected to relinquishing her personal items to staff and made a hand gesture at the nurse when this was requested. The physician entered the room and talked to P1, who was crying. At 1:35 p.m., P1 stood up from the bed and made animated hand gestures to the physician. The physician and two other staff positioned themselves in the doorway, blocking it. Two security staff arrived and positioned themselves in the doorway with the other staff, at which time P1 voluntarily walked to the chair in the exam room and sat down in the chair. At 1:40 p.m., P1 remained seated in the chair, cooperative and not violent or aggressive. P1 then refused to relinquish her coat to staff. A Code 21 was enacted. Additional staff arrived. At 1:45 p.m., seven staff were present in P1's room during which time P1 remained seated calmly in the chair with no threats of physical violence. At 1:46 p.m., the physician re-entered P1's room along with six other staff; several additional staff readied seclusion room #14 for P1. At 1:50 p.m., multiple staff formed a human wall in front of P1, who was still seated calmly in the chair in exam room #12. In a unified force, staff removed P1 from the chair to the floor, face-down, and restrained P1 from all sides including laying across P1's torso/lower extremities. P1 was motionless. Staff then placed P1 on a backboard and carried P1 to seclusion room #14. Thirteen staff were in seclusion room #14 with P1, including the physician. The door to seclusion room #14 was left wide open while eleven staff held P1 down and removed her clothes. At 2:01 p.m., P1 began to physically fight the staff as they unclothed her. Staff placed a blanket over P1's legs when it became apparent P1 was not wearing any under garments. A nurse holding a syringe was waiting by the doorway. After staff dressed P1 in orange scrubs, staff pulled P1 onto mat, face-down. The nurse gave P1 an injection. Staff wrapped P1's legs with a canvas binder. At 2:05 p.m., all staff left P1's room. P1 was in a prone position on the mat with her legs bound.

During an interview with the restraint committee co-chair (P) and senior clinical education specialist (Q) on 5/23/2018 at 1:20 p.m., they stated after their review of the video of P1's restraint in the ED on 2/25/2018, the restraint did not appear to meet criteria for patient safety and restraint use. Although the video had no sound, P1 did not appear to be violent or self destructive at the time the restraint was used. It appeared staff got tired of waiting for P1 to cooperate with changing her clothes and the staff took control. Employees P and Q stated they were alarmed by the level of intrusion for P1, and they observed many missed opportunities to give P1 space and gain her cooperation in less intrusive ways.

Six psychiatric associates/PAs (PA/CC, PA/DD, PA/EE, PA/FF, PA/GG, and PA/HH) who work on adult inpatient mental health units were interviewed on 05/22/18. All six psychiatric associates stated they are routinely assigned to the Code 21 team that responds to patient behavioral incidents throughout the hospital. Approximately one-third to one-half of the Code 21 incidents occur in the ED, requiring their response assistance at least once a shift and sometimes up to three times a shift. When they arrive on the incident scene in ED, ED staff and Security staff are already there with the patient constituting a group of about six to eight staff. After inpatient mental health staff arrive as part of the "show of force" to get the patient to comply, approximately eleven or twelve staff surround the patient. Security staff often already have the patient on the floor. Most of the time, the patient is refusing to change into orange scrubs, per policy for all mental health patients in the ED; orange scrubs are a quick identifier of patients with mental health or behavioral issues. If a patient continues to refuse to change into the scrubs after a show of force, a group of eight to ten staff restrain the patient, remove the patient's clothes, and dress the patient in scrubs.

Three registered nurses who work in the ED (RN/Z, RN/AA, and RN/BB) were interviewed on 05/22/18 and confirmed that orange scrubs serve as the "visual" to identify ED patients with mental health or chemical dependency issues; orange scrubs signify the patient has been searched and should not be out of their room, unattended.

The document titled Memo, dated April 19, 2018 and provided by hospital staff revealed:

Expectations of responding to a Code Green/Code 21 Team and ED staff: In order to improve service to patients that seek care at the West Bank ED for their mental illness or chemical dependence, standard expectations are being set for ED staff and the responding Code 21/green team. This will allow for enhanced collaboration between the responding Code 21/green team and ED staff. Attached to the memo are the ED search Guidelines.

1. All Behavioral Health/Chemical Dependency (BH/CD) patients that arrive in the ED MUST have a safety screen completed. The search is necessary to keep the patient and staff safe. This is different from the standard on the BH units.

2. A Code Green or Code 21 may be necessary if a patient refuses to be searched or change into scrubs...

6. The patient will then be searched and changed into scrubs. The RN will direct the team if restraints/seclusion is required.

This document has no notation of an initiate date, or approval by any hospital governing body or committee.

The Hospital Policy titled restraint or Seclusion , dated 6/17/2018 and provided by hospital staff and approved by the hospital Clinical Quality and Policy Group was reveiewed.

Under Philosophy: Fairview Health Services recognized the unique needs associated with the care of the patient whose actions pose a safety risk to self or others. The use of restraint or seclusion poses an inherent risk to the physical safety and the psychological well-being of the patient and staff. Therefore:

I. Fairview Health Services will strive to prevent, reduce and when possible eliminate the use of restraint and seclusion. The safety of the patient, staff or others is the basis for initiating or discontinuing the use of restraint or seclusion.

II. Least Restrictive alternatives/interventions and environment are the first choice unless safety issues demand an immediate physical response.

III. When restraint or seclusion is used, particular attention is given to preserving the patient's safety and dignity; these interventions are discontinued at the earliest time possible.

IV. The use of restraint or seclusion for coercion, discipline convenience or retaliation by staff is not permitted.

V. Restraint or seclusion for violent/self-destructive behavior is used only in an emergency, when there is imminent risk of a patient physically harming self, a staff member or others.

Based on interview and document review, the hospital failed to implement an effective process for Quality Assessment and Performance program (QAPI) that reflected the need for patient safety and enhanced health outcomes when the hospital leadership failed monitor the use of restraint or seclusion at their facility and implement actions to ensure that restraint and seclusion was used only to ensure the physical safety of the patient, staff and others. This had the potential to affect all patients who presented to the Emergency Department (ED) for mental health treatment.

The hospital's failure to incorporate surveillance activities of patients presenting to the ED for Mental Health treatment and being coerced or restrained by hospital staff to comply with an unapproved hospital requirement to change into orange "behavioral" scrubs, without patient consent, resulted in the hospital's inability to meet the Condition of Participation of Quality Assessment Performance Improvement at 42 CFR 428.21.

A review of 20 medical records established that 3 of 20 patients were forced or coerced into changing into hospital behavioral scrubs against their will, including 1 patient who was restrained, stripped and forced into hospital scrubs by up to 12 hospital staff when there was no evidence in the medical record that the patient was violent, or indicated she was in imminent danger to hurt herself or anyone else. There was no evidence of any QAPI activity related to this high-risk practice.

Based on interview and document review, the governing body failed to ensure the hospital had a QAPI program that reflected the complexity of the hospital's patient care services for all patients including 1 of 20 patients (P1) reviewed. P1 declined to change into the hospital's behavioral scrubs, was not an imminent danger to herself or anyone else, but was restrained, stripped and searched and forcibly changed into hospital scrubs by hospital staff. This had the potential to affect all patients who presented to the Emergency Department (ED) for mental health treatment. (A308)

Based on interview and document review, the governing body failed to ensure the hospital had a Quality Assessment and Performance Improvement (QAPI) program that reflected the complexity of the hospital's patient care services for all patients including 1 of 20 patients (P1) reviewed. P1 declined to change into the hospital's behavioral scrubs, was not an imminent danger to herself or anyone else, but was restrained, stripped and searched and forcibly changed into hospital scrubs by hospital staff. This had the potential to affect all patients who presented to the Emergency Department (ED) for mental health treatment. Finding include:

A review of P1's medical record revealed P1 presented to the hospital through the ED on 2/25/2018 at 1:22 p.m. P1 came to the emergency room via a car.

P1's history and physical dated 2/25/2018 revealed She had a history of Anxiety, depression, Psychosis, Polysubstance abuse and Post Traumatic Stress Disorder. P1's history included rape.

P1 psychiatric evaluation on 2/25/2018 revealed her behavior was normal.

The medical record section dated 2/25/2018 titled ED course revealed: "She refused her vital signs but appeared in no emotional distress. She was paranoid, and at times appeared to respond to internal stimuli. She made numerous delusional statements, alleging hospital staff were trying to persecute her or harm her or harm her baby (the patient does not have a baby.) The patient refused to be searched or to go into the room and ultimately a code 21 was called and the patient required physical restraint and treatment of psychosis with Zyprexa." There was no evidence in the medical record that P1 was violent, or indicated she was in imminent danger to hurt herself or anyone else.

Investigators reviewed the video recording that captured the time P1 entered exam room #12 at 1:25 p.m. on 02/25/18, until P1 was situated in seclusion room #14 at 2:05 p.m. on 02/25/18. Exam Room #12 is a designated mental health room. The video does not have audio. Multiple staff appear to be verbally interacting with P1 throughout the video. The video shows: At 1:25 p.m., P1 walked into exam room #12 cooperatively, removed her shoes, and sat on the bed. A nurse then entered room #12, carrying orange scrubs for P1. P1 cooperated with the nurse at the bedside. P1 then objected to relinquishing her personal items to staff and made a hand gesture at the nurse when this was requested. The physician entered the room and talked to P1, who was crying. At 1:35 p.m., P1 stood up from the bed and made animated hand gestures to the physician. The physician and two other staff positioned themselves in the doorway, blocking it. Two security staff arrived and positioned themselves in the doorway with the other staff, at which time P1 voluntarily walked to the chair in the exam room and sat down in the chair. At 1:40 p.m., P1 remained seated in the chair, cooperative and not violent or aggressive. P1 then refused to relinquish her coat to staff. A Code 21 was enacted. Additional staff arrived. At 1:45 p.m., seven staff were present in P1's room during which time P1 remained seated calmly in the chair with no threats of physical violence. At 1:46 p.m., the physician re-entered P1's room along with six other staff; several additional staff readied seclusion room #14 for P1. At 1:50 p.m., multiple staff formed a human wall in front of P1, who was still seated calmly in the chair in exam room #12. In a unified force, staff removed P1 from the chair to the floor, face-down, and restrained P1 from all sides including laying across P1's torso/lower extremities. P1 was motionless. Staff then placed P1 on a backboard and carried P1 to seclusion room #14. Thirteen staff were in seclusion room #14 with P1, including the physician. The door to seclusion room #14 was left wide open while eleven staff held P1 down and removed her clothes. At 2:01 p.m., P1 began to physically fight the staff as they unclothed her. Staff placed a blanket over P1's legs when it became apparent P1 was not wearing any under garments. A nurse holding a syringe was waiting by the doorway. After staff dressed P1 in orange scrubs, staff pulled P1 onto mat, face-down. The nurse gave P1 an injection. Staff wrapped P1's legs with a canvas binder. At 2:05 p.m., all staff left P1's room. P1 was in a prone position on the mat with her legs bound.

Six psychiatric associates/PAs (PA/CC, PA/DD, PA/EE, PA/FF, PA/GG, and PA/HH) who work on adult inpatient mental health units were interviewed on 05/22/18. All six psychiatric associates stated they are routinely assigned to the Code 21 team that responds to patient behavioral incidents throughout the hospital. Approximately one-third to one-half of the Code 21 incidents occur in the ED, requiring their response assistance at least once a shift and sometimes up to three times a shift. When they arrive on the incident scene in ED, ED staff and Security staff are already there with the patient constituting a group of about six to eight staff. After inpatient mental health staff arrive as part of the "show of force" to get the patient to comply, approximately eleven or twelve staff surround the patient. Security staff often already have the patient on the floor. Most of the time, the patient is refusing to change into orange scrubs, per policy for all mental health patients in the ED; orange scrubs are a quick identifier of patients with mental health or behavioral issues. If a patient continues to refuse to change into the scrubs after a show of force, a group of eight to ten staff restrain the patient, remove the patient's clothes, and dress the patient in scrubs.

Three registered nurses who work in the ED (RN/Z, RN/AA, and RN/BB) were interviewed on 05/22/18 and confirmed that orange scrubs serve as the "visual" to identify ED patients with mental health or chemical dependency issues; orange scrubs signify the patient has been searched and should not be out of their room, unattended.

The document titled Memo, dated April 19, 2018 and provided by hospital staff revealed:

Expectations of responding to a Code Green/Code 21 Team and ED staff: In order to improve service to patients that seek care at the West Bank ED for their mental illness or chemical dependence, standard expectations are being set for ED staff and the responding Code 21/green team. This will allow for enhanced collaboration between the responding Code 21/green team and ED staff. Attached to the memo are the ED search Guidelines.

1. All Behavioral Health/Chemical Dependency (BH/CD) patients that arrive in the ED MUST have a safety screen completed. The search is necessary to keep the patient and staff safe. This is different from the standard on the BH units.

2. A Code Green or Code 21 may be necessary if a patient refuses to be searched or change into scrubs...

6. The patient will then be searched and changed into scrubs. The RN will direct the team if restraints/seclusion is required.

This document has no notation of an initiate date, or approval by any hospital governing body or committee.

The Hospital Policy titled restraint or Seclusion , dated 6/17/2018 and provided by hospital staff and approved by the hospital Clinical Quality and Policy Group was reveiewed.

Under Philosophy: Fairview Health Services recognized the unique needs associated with the care of the patient whose actions pose a safety risk to self or others. The use of restraint or seclusion poses an inherent risk to the physical safety and the psychological well-being of the patient and staff. Therefore:

I. Fairview Health Services will strive to prevent, reduce and when possible eliminate the use of restraint and seclusion. The safety of the patient, staff or others is the basis for initiating or discontinuing the use of restraint or seclusion.

II. Least Restrictive alternatives/interventions and environment are the first choice unless safety issues demand an immediate physical response.

III. When restraint or seclusion is used, particular attention is given to preserving the patient's safety and dignity; these interventions are discontinued at the earliest time possible.

IV. The use of restraint or seclusion for coercion, discipline convenience or retaliation by staff is not permitted.

V. Restraint or seclusion for violent/self-destructive behavior is used only in an emergency, when there is imminent risk of a patient physically harming self, a staff member or others.

During an interview with the Vice President for Quality and Safety (VP-T) on 5/23/2018 at 10:20 a.m., she stated that the QAPI committee had not reviewed nor approved the ongoing practice in the ED of forcing mental health patients to don scrubs against their will. VP-T stated although it seemed this practice was going on for a long time, the QAPI committee had never reviewed this procedure. Although staff members voiced concern related to the process and the concern was forwarded to the regulatory compliance team in early April, and the QAPI committee met after these things took place in late April, the QAPI team was never made aware of the concern.

The document titled University of Minnesota Health Quality Assurance and Performance Improvement Plan 2018, provided by hospital staff was reviewed. Under Purpose: The purpose of the Quality Assessment and Performance Improvement Plan is to delineate how the University of Minnesota utilizes objective measures to monitor, evaluate, and improve the quality of services provided to patients. Under Guiding Principles: The organization values the following: Continuous improvement and measuring progress toward goals, Transparency and sharing knowledge, Just culture tenets and a focus on systemic opportunities for improvement, Pursuit of highly reliable system and processes. The Lead Quality Committee is responsible for oversight of the execution and evaluation of the QAPI plan.