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Based on observations, staff interviews, and record reviews, the Condition of Participation: Patient Rights was not met as evidenced by the hospital's failure to provide sufficient interventions to ensure each patient's rights were protected.

Refer to:

154: Failure to ensure that a patient was free from restraints as evidenced by the failure to demonstrate that the patient was an immediate physical safety risk to self and/or others.

167: Failure to ensure patients were free from injury during the implementation of restraints.

179: Failure to show evidence that a physician, licensed independent provider (LIP), and/or trained registered nurse (RN), had conducted a one-hour face to face assessment after initiation of a chemical and/or physical restraint to evaluate the patient's immediate situation; reaction to the intervention; medical and behavioral condition; and need to continue or terminate the restraint.

Based on staff interview and record review the hospital failed to ensure that one applicable patient (Patient #4) was free from restraints as evidenced by the failure to demonstrate that the patient was an immediate physical safety risk to self and/or others. Findings include:

Per record review Patient # 4 had a past medical history of asthma, depression, and post-traumatic stress disorder. S/He was admitted to the Emergency Department (ED) on 12/16/19 at 8:48 PM; and subsequently discharged to home at 12:02 AM on 12/17/19.

Per review of a nursing triage note from 12/16/19 at 8:48 PM the patient was brought to the ED by family and had showed signs of intoxication. The nursing triage note read, "family reports patient was dropped off at there house by friends, unresponsive". At 8:51 PM, "once in the bed. pt woke up and got agitated and angry. 'let go of me'". At 8:58 PM, "Pt given 5 mg(milligrams) IM (intramuscular) Haldol (anti-psychotic medication) for being aggressive towards staff. Hands on by security when patient screamed, 'don't let them put anything on me'". At 9:41 PM, "Pt in 4 point restraint, shouting at staff, 'I was in private school and they put me in restraints and I go psychotic'".

Per review of a physician's progress note from 12/16/19 at 11:14 PM, it read, "Patient is oriented to person, place, time, and purpose., Affect, agitated, belligerent, No suicidal ideations. Patient was very initially unresponsive and then ......became very agitated and needed Haldol".

Per review of the "Certificate of Need for an Emergency Involuntary Treatment" (CON) from 12/16/19 for Patient #4, the patient was manually restrained at 8:48 PM, given involuntary medication at 8:56 PM, and mechanically restrained at 9:15 PM.

There was no evidence in the above nursing and physician progress notes that indicated the patient was an immediate physical safety risk to him/her-self and others prior to the application of the chemical and physical restraints.

Upon further review of the CON for Patient #4 from 12/16/19, the patient/treatment team debriefing read, "Pt became agitated after security went 'hands on'. Pt was rolling towards the edge of the bed, when security placed hands to prevent pt. from getting out of bed .....Triage RN (Registered Nurse) did not believe pt's harm or staff's safety was at risk prior to putting 'hands on' by security .....Prior to manual restraint no alternative interventions were provided".

Per interview on 2/5/20 at 8:00 AM with an ED RN (#2) s/he stated that s/he had been working as the charge nurse on 12/16/19. S/He had heard loud voices and yelling going on and s/he entered the room to assess the situation with Patient #4. S/He stated that security had manually restrained the patient as s/he was being aggressive and yelling toward staff. S/He stated that s/he recalled that the patient had been trying to get out of bed and that security was trying to prevent the patient from falling out of the bed. S/He stated that the patient was given involuntary medications and placed in mechanical restraints. S/He stated that "threatening statements toward staff would be reason to use involuntary medications and restraints".

Per interview on 2/5/20 at 9:28 AM with a Security Guard s/he stated that Patient #4 had come into the ED unresponsive and intoxicated. S/He stated that s/he followed the patient and the triage nurse to the patient's room in the ED out of "safety concerns". S/He stated that s/he was outside of the patient's room and the patient woke up and was trying to leave. The ED technician who was caring for the patient "went hands on". The patient had a couple of family members in the room with him/her and one of the family members was also holding on to the patient. S/He stated that at that point s/he had asked the family member to let go of the patient and s/he put hands on the patient because the patient was attempting to get out of the bed to leave. S/He was informed by the staff that the patient was intoxicated and not "legally able to leave". There was also no indication in the medical record that the patient was under arrest and/or was obligated to stay in the ED.

Per interview on 2/5/20 at 9:55 AM with the Director of the ED, s/he stated that Patient #4 was "fairly well known" to the ED staff. S/He had a history of being aggressive and assaultive when s/he came into the ED. S/He stated that the facility was "limited on the night shift" and often security comes to help the staff for anything that the staff may need. S/He stated that the security officer on duty saw what was happening and came to help the staff. S/He stated that "if there is an immediate violence threat, they intervene, promote a violence free workplace". S/He stated that s/he spoke to the triage nurse involved with Patient #4 and the nurse expressed that s/he could handle the patient and the situation; however, security felt otherwise. S/He confirmed that the "documentation does not show" that the restraint use was appropriate for Patient #4.

Per review of the policy "Patient Rights and Responsibilities"-approved 10/22/18, it read, "Procedure: A. Patient Rights 4. Patients have the right to refuse treatment, except in exceptional circumstances. 11. CVMC will use restraints or seclusion only if they are necessary to ensure physical safety, and if no less restrictive intervention is possible."

Based on staff interview and record review, the hospital failed to ensure restraints were implemented safely as evidenced by injuries sustained by 2 of 10 applicable patients (Patient #1 and Patient #8) during restraint techniques. Findings include:

1. Per review of a nursing triage note from 12/6/19 at 8:47 PM, Patient #1 presented to the ED with a "psychiatric problem" and had stated that s/he wanted to see a crisis screener while in the ED. S/He refused to state what problems s/he was having and refused vital signs. The patient was anxious and agitated with a flat affect.

Per review of a Mental Health Technician's (MHT) note for Patient #1 from 12/7/19 at 1:30 AM, "Patient not calm, Pt. is flooding the TCA(Transitional Care Area of the ED that contains 3 safe/secure rooms for mental health patients with continuous observation) by flushing the toilet so much to the point it has flowed into the TCA nurse station. Pt. laughing at staff at staff attempts to clean the mess. Pt. is still pacing the hallway singing loudly and flushing the toilet to make the flooding worse ......pt is being threatening to staff by posturing. At 2:08 AM, "Patient not calm, RN notified. pt. was given the option to walk to" his/her "room by" him/her-self "or staff would assist" him/her "in doing so. pt. declined to walk by" him/her-self. At 1:48 AM "this MHT secured the left arm of pt. and security secured the right arm. This MHT gave a loud and clear command to get on the ground while this righter was helping to bring patient to a controlled prone position. while pt. was being brought to the prone position the right arm was let go so pt. could catch" him/her-self "but pt. hit" his/her "head on the floor. pt was given IM meds" at 1:49 AM "and brought to room and seclusion started at" 1:52 AM. "this was all done using MOAB (principles, techniques, and skills for recognizing, reducing, and managing violent and aggressive behavior) approved techniques. pt. was offered ice pack" at 1:59 AM ......pt declined and stated" s/he "did not want one".

Per review of a nursing progress note for Patient #1 from 12/7/19 at 1:30 AM, "pt pacing in the TCA ... ....Pt was again asked to go to" his/her "room because" his/her "behavior was aggressive and inappropriate and offered PO (by mouth) medication which the pt again refused. Decision was made by" MD "to involuntarily medicate pt. PT fought involuntary medication, was brought to ground in controlled fashion and medicated with Ativan (anti-anxiety medication), Benadryl (antihistamine medication) and Haldol. PT secluded in room, appropriate paperwork initiated". At 2:48 AM, "pt acting appropriately in room, lying down, resting, seclusion discontinued" at 2:34 AM. At 3:29 AM, "pt sleeping, no s/s of distress". At 4:55 AM, "pt sleeping, no s/s of distress". At 8:42 AM, "pt requested to have" his/her "eye to be checked by someone after being injured in a code green (behavioral emergency)incident involving pt last night. Asked" MD "to check pt's eye". At 7:25 PM, "PA asked to evaluate patient's eye from injury which occurred overnight during code green".

Per review of a physician progress note for Patient #1 from 12/7/19 at 6:40 AM, "Patient became very agitated and aggressive posturing towards staff and threatening to hurt somebody ... ...Ultimately due to" his/her "struct of behavior and the T-zone where" s/he "continued to flush the toilet ....by flooding the area, patient was restrained and given 10 mg of Haldol, 2 mg of Ativan and Benadryl .....Patient then able to sleep comfortably overnight and awaits reevaluation in the morning". At 7:32 PM, "was summoned to evaluate the patient's right eye. On exam patient refused to comply with physical exam of right eye. Refused to open" his/her "eye ......does have ecchymosis over the upper eyelid of the right eye. Patient is unwilling to allow ...to palpate around the orbit. Patient refuses all imaging. Eye is not swollen shut".

Per the above nursing progress note, there was no indication that Patient #1 had sustained an injury during the restraint procedure until 8:42 AM; approximately six hours and forty-five minutes after the injury occurred. There was also no evidence in the physician's progress note that the patient had sustained an injury during the application of a restraint; and/or that an assessment/evaluation of the patient's injury was done until approximately seventeen hours after the injury had occurred.

Per interview on 2/4/20 at 7:35 AM with an ED RN (#1), s/he stated that Patient #1 was in the ED for behavioral health reasons. S/He stated that the staff were having a hard time convincing the patient to stay in the ED and getting the patient to go to the TCA; however, eventually the patient agreed to walk to the TCA on his/her own accord. Once in the TCA, s/he became verbally aggressive with the staff. S/He was pacing and banging on the windows in the area. The staff had given the patient multiple opportunities to go to his/her room to calm down. S/He stated that the patient continued to refuse to cooperate with the staff and eventually the patient was brought down to the ground. S/He stated that the patient fought the staff all the way to the ground. S/He stated that s/he was aware that the patient had hit his/her head; and at that point it was "more important" to administer the involuntary medications and get the patient to his/her room. S/He stated that once the patient was in the room the patient could be better assessed for injury. S/He stated that a quick assessment was done by him/her as the patient was observed to be conscious, talking, and oriented; and that the physician was also aware that the patient had hit his/her head. S/He confirmed that s/he "did not document that patient hit head" in the record and/or the assessment and interventions that were provided to the patient.

Per review of the policy "Use of Restraint and Seclusion for Behavioral Health Reasons"-approved 4/17/19, it read, "C. The use of restraint: 1. e) Immediately after the patient is placed in restraint, the RN will assess for signs of any injury associated with the application of restraint and reassess as indicated by patient's condition."


2. Per record review, Patient #8 presented to the Emergency Department on 11/8/2019 with thoughts of self-harm. S/He had a documented history of anxiety and the chief complaint per nursing progress notes was documented to be a, "psychiatric problem". Patient #8 required manual restraint at 2:25 PM on 11/9/2019 due to, attempts "to hit staff with fist numerous times." Per physician notes s/he, "attempted to hit staff multiple times, a code green (behavioral emergency code) was called and the patient was taken to the floor using MOAB (Management of Aggressive behavior program) techniques that lasted perhaps 90 seconds". Per documentation on the "Certificate of Need for Emergency Involuntary Procedures" (CON) Patient #8 was assessed by the physician at 2:37 PM. The physician's documentation indicated the reason for the restraint as, "serious physical harm to others or imminent danger of serious physical harm to others". Per nursing progress notes, "pt then complained of wrist pain- dr addressed it immediately following being advised of the issue." Per physician note at 2:40 PM on 11/9/2019, the patient, "subsequent..complained of wrist pain to the left side. Physical exam the left wrist showed no obvious trauma just mild tenderness to palpation...wrist films obtained it was negative for fracture or other acute findings".

During an interview at 10:55 AM on 11/5/2020 the Director of Quality stated that s/he was not aware of injuries sustained during restraints. There was no evidence available to demonstrate that restraint techniques were reviewed to determine whether or not they were implemented appropriately to minimize the risk of injury to patients.

Based on staff interview and record review the hospital failed to show evidence that a physician, licensed independent provider (LIP), and/or trained registered nurse (RN), had conducted a one hour face to face assessment after the initiation of chemical and/or physical restraints to evaluate the patient's immediate situation; reaction to the intervention; medical and behavioral condition; and need to continue or terminate the restraint(s) for 8 of 10 applicable patients (Patient #1, Patient #3, Patient #4, Patient #6, Patient #7, Patient #8, Patient #9, and Patient #10). Findings include:


1. Per review of a nursing triage note from 12/6/19 at 8:47 PM, Patient #1 presented to the ED with a "psychiatric problem" and was anxious and agitated with a flat affect. Per review of the "Certificate of Need for an Emergency Involuntary Treatment" (CON) from 12/7/19, the patient received a manual restraint from 1:47 AM to 1:52 AM, involuntary medication (2 mg Ativan IM, 10 mg Haldol IM, and 50 mg of Benadryl IM) at 1:49 AM, and seclusion from 1:52 AM to 2:34 AM. The "Physician's Assessment" from the CON indicated that the "clinical condition that required the involuntary treatment" was "yelling, damaging the unit as a means to access staff and postured while yelling at staff". There was no evidence that the physician performed a face to face assessment that included Patient #1's medical and behavioral condition; and the need to continue and/or terminate the restraints (manual, seclusion, and involuntary medication) within 1 hour after their initiation.

2. Per record review, Patient #3 came to the ED on 12/21/19 with tangential thought patterns. S/He had a diagnosis of schizophrenia and a history of violent behavior. It was noted on the CON form dated 12/22/19, that the doctor attempted verbal de-escalation resulting in the patient's agitation becoming elevated. The patient attempted to kick and punch staff and attempted to pick up furniture and throw it. At 7:15 AM, seclusion, manual, and mechanical restraints were used. At 7:27 AM, the patient was given involuntary medication by intramuscular injection (Haldol 10 mg, Lorazepam 2 mg and Benadryl 50 mg). The physician failed to document a face to face evaluation that included an assessment of the patient's medical and behavioral condition, within 1 hour after the initiation of the intervention (seclusion, manual, mechanical and involuntary medication).

3. Per record review on 12/16/19, Patient #4 was brought to the ED by family and had showed signs of intoxication. S/He had a past medical history of asthma, depression, and post-traumatic stress disorder. Per review of the CON from 12/16/19, the patient received a manual restraint at 8:48 PM to 9:20 PM, involuntary medication at 8:56 PM (5 mg of Haldol IM), and mechanical restraints (4-point) from 9:15 PM to 10:25 PM. The "Nursing Assessment" from the CON indicated that the patient "became aggressive and assaultive towards staff, yelling and kicking at staff". The "Physician's Assessment" from the CON indicated that the "clinical condition that required the involuntary treatment" was "aggressive". There was no evidence that the physician performed a face to face assessment that included Patient #4's medical and behavioral condition; and the need to continue and/or terminate the restraints (manual, mechanical, and involuntary medication) within 1 hour after their initiation.

4. Per record review, Patient #6 had a history of ADHD (Attention-Deficit/Hyperactivity Disorder- A chronic condition including attention difficulty, hyperactivity, and impulsiveness.) and was brought to the ED by the police on 10/16/19 because s/he threatened to jump off a roof. The patient was exhibiting aggressive and violent behaviors that could cause significant harm and/or injury to self or others and a restraint was applied. The CON indicated that Patient #6 was put into seclusion from 9:31 PM to 9:48 PM. The physician failed to document a face to face evaluation that included an assessment of the patient's medical and behavioral condition within 1 hour after the initiation of the intervention (seclusion).

5. Per review of a physician's progress note from 11/12/19 at 9:16 PM, Patient #7 had a history of schizophrenia, traumatic brain injury, alcohol abuse, and diabetes and presented to the ED with bleeding from his/her rectum. Per review of the CON from 11/12/19, the patient received a manual restraint at 8:50 PM to 9:00 PM and involuntary medications at 8:50 PM (2 mg Ativan, 5 mg of Haldol IM). The "Physician's Assessment" from the CON(signed by the physician at 8:50 PM, the time the restraints were initiated) indicated that the "clinical condition that required the involuntary treatment" was "patient febrile with concerning hx of heavy bleeding at home, very volatile and aggressive/agitated, trying to leave". There was no evidence that the physician performed a face to face assessment that included Patient #7's medical and behavioral condition; and the need to continue and/or terminate the restraints (manual and involuntary medication) within 1 hour after their initiation.

6. Per record review, Patient #8 presented to the Emergency Department on 11/8/2019 with thoughts of self-harm. S/He had a documented history of anxiety and the chief complaint per nursing progress notes was documented to be a, "psychiatric problem". Patient #8 required manual restraint at 2:25 PM on 11/9/2019 due to, attempts "to hit staff with fist numerous times." Per physician notes s/he, "attempted to hit staff multiple times, a Code Green was called and the patient was taken to the floor using MOAB techniques that lasted perhaps 90 seconds". Per documentation on the "Certificate of Need for Emergency Involuntary Procedures" (CON) Patient #8 was assessed by the physician at 2:37 PM. The physician's documentation indicated the reason for the restraint as, "serious physical harm to others or imminent danger of serious physical harm to others". Documentation in the Physician Assessment also included, "patient attempted to force entry into staff observation...". There was no evidence of a face to face evaluation that included an assessment of the patient's medical and behavioral condition within 1 hour after the initiation of the intervention (seclusion, manual, mechanical and involuntary medication).

7. Per review of a physician's progress note from 10/23/19 at 3:30 PM, Patient #9 presented with a chief complaint of assaultive behavior and had a history of developmental delay and schizoaffective disorder. Per review of the CON from 10/23/19, the patient received a manual restraint at 1:35 PM to 1:36 PM. The "Physician's Assessment" from the CON indicated that the "clinical condition that required the involuntary treatment" was "patient swinging at/punching ED staff in triage, threatened violence". There was no evidence that the physician performed a face to face assessment that included Patient #9's medical and behavioral condition; and the need to continue and/or terminate the restraint (manual) within 1 hour after it's initiation.

8. Per review of a physician's progress note from 10/16/19 at 10:28 PM, Patient #10 had a history of polysubstance abuse and chronic pain. S/He presented to the ED with police after causing a disturbance banging on neighbors' doors with a cane. Per review of the CON from 10/16/19, the patient received involuntary medication (Versed 2 mg (sedative), Haldol 10 mg IM) at 10:20 PM and mechanical restraints (4-point) at 10:25 PM to 11:10 PM. The "Physician's Assessment" from the CON indicated that the "clinical condition that required the involuntary treatment" was "highly agitated and hostile attempting to rip fire alarm off wall". Per review of a CON from 10/17/19, the patient received involuntary medication (2 mg Versed IM) at 12:10 AM. The "Physician's Assessment" from the CON indicated that the "clinical condition that required the involuntary treatment" was "Patient has no logic and has irrational thought process and is aggressive towards staff". There was no evidence that the physician performed a face to face assessment for each of the CON's that included Patient #10's medical and behavioral condition; and the need to continue and/or terminate the restraints (manual, mechanical, and involuntary medication) within 1 hour after their initiation.

Per interview on 2/4/20 at 12:51 PM with the ED Nurse Manager, s/he reviewed the CON process with the surveyors and agreed that the "Physician's Assessment" on the CON explained the reasons why the involuntary treatments were applied, the treatment measures (manual restraint, mechanical restraint, seclusion, and/or involuntary medication) that the provider was authorizing at the time of the application, and the therapeutic response of the patient to the prescribed involuntary treatments. S/He confirmed that s/he did not "see a face to face" assessment documented from physicians within 1 hour after the initiation of restraints that included the patients' medical and behavioral condition; and the need to continue and/or terminate the restraints.

Per review of the policy "Use of Restraints and Seclusion for Behavioral Health Reasons"-approved 4/17/19, it read " E. Physician/Licensed Independent Practitioner (Physician's Assistant or Advanced Practice Nurse authorized to write orders) responsibilities when a patient is in seclusion or restraint: 1. Assess the patient face to face within 1 hour (one hour or less) following the initiation of seclusion or restraint, validate the need for restraint or seclusion and document the rationale for use. 2. Review the appropriateness of the intervention with consideration of the physical and psychological status of the individual with the nursing staff."

Based on staff interview and record review the hospital failed to demonstrate that the Quality Assessment and Performance Improvement program measured and analyzed adverse patient events; and that preventative actions and mechanisms were implemented to improve patient safety for 3 applicable patients (Patient #1, Patient #7 and Patient #8); with the potential to impact all patients in the hospital. Findings include:

1. Per review of a nursing triage note from 12/6/19 at 8:47 PM, Patient #1 presented to the ED with a "psychiatric problem" and was anxious and agitated with a flat affect. Per review of a Mental Health Technician's (MHT) note for Patient #1 from 12/7/19 at 1:30 AM, "Patient not calm, Pt. is flooding the TCA(area of ED that contains 3 safe/secure rooms for mental health patients with continuous observation) by flushing the toilet so much to the point it has flowed into the TCA nurse station. Pt. laughing at staff at staff attempts to clean the mess. Pt. is still pacing the hallway singing loudly and flushing the toilet to make the flooding worse ......pt is being threatening to staff by posturing. At 2:08 AM, "Patient not calm, RN notified. pt. was given the option to walk to" his/her "room by" him/her-self "or staff would assist" him/her "in doing so. pt. declined to walk by" him/her-self. At 1:48 AM "this MHT secured the left arm of pt. and security secured the right arm. This MHT gave a loud and clear command to get on the ground while this righter was helping to bring patient to a controlled prone position. while pt. was being brought to the prone position the right arm was let go so pt. could catch" him/her-self "but pt. hit" his/her "head on the floor. pt was given IM meds" at 1:49 AM "and brought to room and seclusion started at" 1:52 AM. "this was all done using MOAB (principles, techniques, and skills for recognizing, reducing, and managing violent and aggressive behavior) approved techniques. pt. was offered ice pack" at 1:59 AM ......pt declined and stated" s/he "did not want one".

Per review of a nursing progress note from 12/7/19 at 1:30 AM, "pt pacing in the TCA ... ....Pt was again asked to go to" his/her "room because" his/her "behavior was aggressive and inappropriate and offered PO (by mouth) medication which the pt again refused. Decision was made by" MD "to involuntarily medicate pt. PT fought involuntary medication, was brought to ground in controlled fashion and medicated with Ativan (anti-anxiety medication), Benadryl (antihistamine medication) and Haldol. PT secluded in room, appropriate paperwork initiated". At 2:48 AM, "pt acting appropriately in room, lying down, resting, seclusion discontinued" at 2:34 AM. At 3:29 AM, "pt sleeping, no s/s of distress". At 4:55 AM, "pt sleeping, no s/s of distress". At 8:42 AM, "pt requested to have" his/her "eye to be checked by someone after being injured in a code green (behavioral emergency) incident involving pt last night. Asked" MD "to check pt's eye". At 7:25 PM, "PA asked to evaluate patient's eye from injury which occurred overnight during code green".

2. Per review of a physician's progress note from 11/12/19 at 9:16 PM, Patient #7 had a history of schizophrenia, traumatic brain injury, alcohol abuse, and diabetes and presented to the ED with bleeding from his/her bottom. Per review of the CON from 11/12/19, the patient received a manual restraint at 8:50 PM to 9:00 PM and involuntary medications at 8:50 PM (2 mg Ativan, 5 mg of Haldol IM). The "Physician's Assessment" from the CON(signed by the physician at 8:50 PM, the time the restraints were initiated) indicated that the "clinical condition that required the involuntary treatment" was "patient febrile with concerning hx of heavy bleeding at home, very volatile and aggressive/agitated, trying to leave". The physician also noted that the "therapeutic response of the patient to the involuntary treatment" "some resp depression requiring 02(oxygen) supplementation".

3. Per record review, Patient #8 presented to the Emergency Department on 11/8/2019 with thoughts of self-harm. S/He had a documented history of anxiety and the chief complaint per nursing progress notes was documented to be a, "psychiatric problem". Patient #8 required manual restraint at 2:25 PM on 11/9/2019 due to, attempts "to hit staff with fist numerous times." Per physician notes s/he, "attempted to hit staff multiple times, a code green (behavioral emergency code) was called and the patient was taken to the floor using MOAB (Management of Aggressive behavior program) techniques that lasted perhaps 90 seconds". Per physician documentation on the "Certificate of Need for Emergency Involuntary Procedures" (CON) Patient #8 was assessed by the physician at 2:37 PM. The documentation indicated the reason for the restraint was, "serious physical harm to others or imminent danger of serious physical harm to others". Per nursing progress notes, "pt then complained of wrist pain- dr addressed it immediately following being advised of the issue." Per physician note at 3:40 PM on 11/9/2019, the patient, "subsequent...complained of wrist pain to the left side. Physical exam the left wrist showed no obvious trauma just mild tenderness to palpation...wrist films obtained it was negative for fracture or other acute findings".


Per interview on 2/4/19 at 12:51 PM with the ED Nurse Manager, s/he stated that an ED charge nurse was assigned to review the CON forms for their completeness. S/he stated that they were not specifically reviewing each incident as it occurred. The CON packets were collected, and the information was entered into the data base.

Per interview on 2/5/20 at 10:55 AM with the Director of Quality, s/he stated that s/he was not aware of the injuries during restraints. S/He stated that they "need closer eyes on the experience of the staff and patient" and that the hospital needed "to do case reviews of every restraint". S/he also stated that s/he "did not know the scope of the deficit". There was no evidence provided during the investigation demonstrating that adverse patient events occurring during emergency involuntary restraints were being identified and analyzed in order to prevent occurrences in the future.

Based on observations, staff interviews, and record reviews, the Condition of Participation: Emergency Services was not met due to the failure of the hospital to ensure that the emergency needs of 2 of 10 applicable behavioral health patients were met as evidenced by the failure to assess a patient for injury after the initiation of a restraint (Patient #1); and the failure to demonstrate that a patient was an immediate physical safety risk to self and/or others prior to applying a restraint (Patient #4). Findings include:

1. Per review of a nursing triage note from 12/6/19 at 8:47 PM, Patient #1 presented to the Emergency Department (ED) with a "psychiatric problem" and had stated that s/he wanted to see a crisis screener while in the ED. S/He refused to state what problems s/he was having and refused vital signs. The patient was anxious and agitated with a flat affect.

Per review of a Mental Health Technician's (MHT) note for Patient #1 from 12/7/19 at 1:30 AM, "Patient not calm, Pt. is flooding the TCA(area of ED that contains 3 safe/secure rooms for mental health patients with continuous observation) by flushing the toilet so much to the point it has flowed into the TCA nurse station. Pt. laughing at staff at staff attempts to clean the mess. Pt. is still pacing the hallway singing loudly and flushing the toilet to make the flooding worse ......pt is being threatening to staff by posturing. At 2:08 AM, "Patient not calm, RN notified. pt. was given the option to walk to" his/her "room by" him/her-self "or staff would assist" him/her "in doing so. pt. declined to walk by" him/her-self. At 1:48 AM "this MHT secured the left arm of pt. and security secured the right arm. This MHT gave a loud and clear command to get on the ground while this righter was helping to bring patient to a controlled prone position. while pt. was being brought to the prone position the right arm was let go so pt. could catch" him/her-self "but pt. hit" his/her "head on the floor. pt was given IM meds" at 1:49 AM "and brought to room and seclusion started at" 1:52 AM. "this was all done using MOAB (principles, techniques, and skills for recognizing, reducing, and managing violent and aggressive behavior) approved techniques. pt. was offered ice pack" at 1:59 AM ......pt declined and stated" s/he "did not want one".

Per review of a nursing progress note for Patient #1 from 12/7/19 at 1:30 AM, "pt pacing in the TCA ... ....Pt was again asked to go to" his/her "room because" his/her "behavior was aggressive and inappropriate and offered PO (by mouth) medication which the pt again refused. Decision was made by" MD "to involuntarily medicate pt. PT fought involuntary medication, was brought to ground in controlled fashion and medicated with Ativan (anti-anxiety medication), Benadryl (antihistamine medication) and Haldol. PT secluded in room, appropriate paperwork initiated". At 2:48 AM, "pt acting appropriately in room, lying down, resting, seclusion discontinued" at 2:34 AM. At 3:29 AM, "pt sleeping, no s/s of distress". At 4:55 AM, "pt sleeping, no s/s of distress". At 8:42 AM, "pt requested to have" his/her "eye to be checked by someone after being injured in a code green incident involving pt last night. Asked" MD "to check pt's eye". At 7:25 PM, "PA asked to evaluate patient's eye from injury which occurred overnight during code green".

Per review of a physician progress note for Patient #1 from 12/7/19 at 6:40 AM, "Patient became very agitated and aggressive posturing towards staff and threatening to hurt somebody ... ...Ultimately due to" his/her "struct of behavior and the T-zone where" s/he "continued to flush the toilet ....by flooding the area, patient was restrained and given 10 mg of Haldol, 2 mg of Ativan and Benadryl .....Patient then able to sleep comfortably overnight and awaits reevaluation in the morning". At 7:32 PM, "was summoned to evaluate the patient's right eye. On exam patient refused to comply with physical exam of right eye. Refused to open" his/her "eye ......does have ecchymosis over the upper eyelid of the right eye. Patient is unwilling to allow ...to palpate around the orbit. Patient refuses all imaging. Eye is not swollen shut".
Per the above nursing progress note, there was no indication that Patient #1 had sustained an injury during the restraint procedure until 8:42 AM; approximately six hours and forty-five minutes after the injury occurred. There was also no evidence in the physician's progress note that the patient had sustained an injury during the application of a restraint; and/or that an assessment/evaluation of the patient's injury was done until approximately seventeen hours after the injury had occurred.

Per interview on 2/4/20 at 7:35 AM with an ED RN (#1), s/he stated that Patient #1 was in the ED for behavioral health reasons. S/He stated that the staff were having a hard time convincing the patient to stay in the ED and getting the patient to go to the TCA; however, eventually the patient agreed to walk to the TCA on his/her own accord. Once in the TCA, s/he became verbally aggressive with the staff. S/He was pacing and banging on the windows in the area. The staff had given the patient multiple opportunities to go to his/her room to calm down. S/He stated that the patient continued to refuse to cooperate with the staff and eventually the patient was brought down to the ground. S/He stated that the patient fought the staff all the way to the ground. S/He stated that s/he was aware that the patient had hit his/her head; and at that point it was "more important" to administer the involuntary medications and get the patient to his/her room. S/He stated that once the patient was in the room the patient could be better assessed for injury. S/He stated that a quick assessment was done by him/her as the patient was conscious, talking, and oriented; and that the physician was also aware that the patient had hit his/her head. S/He confirmed that s/he "did not document that patient hit head" in the record and/or the assessment and interventions that were provided to the patient.

Per interview on 2/4/20 at 8:08 AM with the ED Medical Director, s/he stated that "ideally" a patient should be assessed/evaluated after sustaining any injury in the hospital setting. S/He stated that s/he reviewed Patient #1's record and that there was "no evidence whether or not the provider saw the patient" after the patient had sustained the injury to his/her right eye.

Per review of the policy "Use of Restraint and Seclusion for Behavioral Health Reasons"-approved 4/17/19, it read, "C. The use of restraint: 1. e) Immediately after the patient is placed in restraint, the RN will assess for signs of any injury associated with the application of restraint and reassess as indicated by patient's condition."



2. Per record review Patient # 4 had a past medical history of asthma, depression, and post-traumatic stress disorder. S/He was admitted to the Emergency Department (ED) on 12/16/19 at 8:48 PM; and subsequently discharged to home at 12:02 AM on 12/17/19.

Per review of a nursing triage note from 12/16/19 at 8:48 PM the patient was brought to the ED by family and had showed signs of intoxication. The nursing triage note read, "family reports patient was dropped off at there house by friends, unresponsive". At 8:51 PM, "once in the bed. pt woke up and got agitated and angry. 'let go of me'". At 8:58 PM, "Pt given 5 mg(milligrams) IM (intramuscular) Haldol (anti-psychotic medication) for being aggressive towards staff. Hands on by security when patient screamed, 'don't let them put anything on me'". At 9:41 PM, "Pt in 4 point restraint, shouting at staff, 'I was in private school and they put me in restraints and I go psychotic'".

Per review of a physician's progress note from 12/16/19 at 11:14 PM, it read, "Patient is oriented to person, place, time, and purpose., Affect, agitated, belligerent, No suicidal ideations. Patient was very initially unresponsive and then ......became very agitated and needed Haldol".

Per review of the "Certificate of Need for an Emergency Involuntary Treatment" (CON) from 12/16/19 for Patient #4, the patient was manually restrained at 8:48 PM, given involuntary medication at 8:56 PM, and mechanically restrained at 9:15 PM.

There was no evidence in the above nursing and physician progress notes that indicated the patient was an immediate physical safety risk to him/her-self and others prior to the application of the chemical and mechanical restraints.

Upon further review of the CON for Patient #4 from 12/16/19, the patient/treatment team debriefing read, "Pt became agitated after security went 'hands on'. Pt was rolling towards the edge of the bed, when security placed hands to prevent pt. from getting out of bed .....Triage RN (Registered Nurse) did not believe pt's harm or staff's safety was at risk prior to putting 'hands on' by security .....Prior to manual restraint no alternative interventions were provided".

Per interview on 2/5/20 at 8:00 AM with an ED RN (#2) s/he stated that s/he had been working as the charge nurse on 12/16/19. S/He had heard loud voices and yelling going on and s/he entered the room to assess the situation with Patient #4. S/He stated that security had manually restrained the patient as s/he was being aggressive and yelling toward staff. S/He stated that s/he recalled that the patient had been trying to get out of bed and that security was trying to prevent the patient from falling out of the bed. S/He stated that the patient was given involuntary medications and placed in mechanical restraints. S/He stated that "threatening statements toward staff would be reason to use involuntary medications and restraints".

Per interview on 2/5/20 at 9:28 AM with a Security Guard s/he stated that Patient #4 had come into the ED unresponsive and intoxicated. S/He stated that s/he followed the patient and the triage nurse to the patient's room in the ED out of "safety concerns". S/He stated that s/he was outside of the patient's room and the patient woke up and was trying to leave. The ED technician who was caring for the patient "went hands on". The patient had a couple of family members in the room with him/her and one of the family members was also holding on to the patient. S/He stated that at that point s/he had asked the family member to let go of the patient and s/he put hands on the patient because the patient was attempting to get out of the bed to leave. S/He was informed by the staff that the patient was intoxicated and not "legally able to leave". There was also no indication in the medical record that the patient was under arrest and/or was obligated to stay in the ED.

Per interview on 2/5/20 at 9:55 AM with the Director of the ED, s/he stated that Patient #4 was "fairly well known" to the ED staff. S/He had a history of being aggressive and assaultive when s/he came into the ED. S/He stated that the facility was "limited on the night shift" and often security comes to help the staff for anything that the staff may need. S/He stated that the security officer on duty saw what was happening and came to help the staff. S/He stated that "if there is an immediate violence threat, they intervene, promote a violence free workplace". S/He stated that s/he spoke to the triage nurse involved with Patient #4 and the nurse expressed that s/he could handle the patient and the situation; however, security felt otherwise. S/He confirmed that the "documentation does not show" that the restraint use was appropriate for Patient #4.

Per review of the policy "Patient Rights and Responsibilities"-approved 10/22/18 it read, "Procedure: A. Patient Rights 4. Patients have the right to refuse treatment, except in exceptional circumstances. 11. CVMC will use restraints or seclusion only if they are necessary to ensure physical safety, and if no less restrictive intervention is possible."