HospitalInspections.org

Based on policy review, medical record review, video taped footage review, staff interview, personnel file review, hospital investigation report review, restraint log review, and adverse event report review, the hospital's Governing Body failed to provide oversight and have systems in place to ensure the protection of patients' rights, an effective quality assessment and performance improvement program, and an organized nursing service to ensure the safety of patients.

The findings include:

1. The hospital failed to promote and protect patients' rights by failing to ensure: a safe setting for patient care, implementation of restraints in accordance with safe and appropriate techniques, physicians' orders for restraints, restrained patients were monitored by trained staff to ensure safety, least restrictive measures were used for restrained patients, safe application of restraints by trained staff, and appropriate staff were trained in the use of nonphysical intervention skills.

~cross refer to 482.13 Patient Rights' Condition: Tag A0115

2. The hospital failed to implement and maintain an effective quality assessment and performance improvement program to ensure the safety of patients.

~cross refer to 482.21 Quality Assessment/Performance Improvement Condition: Tag A0263

3. The hospital failed to have an organized nursing service providing oversight of day-to-day operations to ensure registered nursing staff supervised and evaluated patient care and ensure nursing staff were trained and competent to ensure the safe and appropriate physical restraint of patients.

~cross refer to 482.23 Nursing Services Condition: Tag A0385

Based on policy review, medical record review, video taped footage review, staff interview, personnel file review, and hospital investigation report review, the hospital failed to promote and protect patients' rights by failing to ensure: a safe setting for patient care, implementation of restraints in accordance with safe and appropriate techniques, physicians' orders for restraints, restrained patients were monitored by trained staff to ensure safety, least restrictive measures were used for restrained patients, safe application of restraints by trained staff, and appropriate staff were trained in the use of nonphysical intervention skills.

Findings include:

1. The hospital failed to ensure care in a safe setting by failing to ensure restraints were applied by trained and competent staff and failing to ensure patients in restraint were monitored by trained and competent staff to assure patient safety.

~ cross refer to 482.13(c)(2) Patient Rights' Standard: Tag 0144

2. The hospital failed to ensure physical restraint was implemented in accordance with safe and appropriate techniques.

~ cross refer to 482.13(e)(4)(ii) Patient Rights' Standard: Tag 0167

3. The hospital failed to ensure a physician's order for physical restraint.

~ cross refer to 482.13(e)(5) Patient Rights' Standard: Tag 0168

4. The hospital failed to ensure restrained patients were monitored by trained staff.

~ cross refer to 482.13(e)(10) Patient Rights' Standard: Tag 0175

5. The hospital failed to ensure staff attempted the use of least restrictive interventions prior to restraint.

~ cross refer to 482.13(e)(16)(iii) Patient Rights' Standard: Tag 0186

6. The the hospital failed to ensure safe implementation of restraint by trained staff.

~ cross refer to 482.13(f) Patient Rights' Standard: Tag 0194

7. The hospital failed to ensure Emergency Department and Contracted Security staff were trained in the use of nonphysical intervention skills.

~ cross refer to 482.13(f)(2)(ii) Patient Rights' Standard: Tag 0200

Based on policy review, medical record review, video taped footage review, staff interview, personnel file review, and hospital investigation report review, the hospital failed to ensure care in a safe setting by failing to ensure restraints were applied by trained and competent staff and failing to ensure patients in restraint were monitored by trained and competent staff to assure patient safety for 3 of 11 sampled patients that were restrained (Patients #5, #2, and #7).

The findings include:

Review of hospital policy entitled "Restraints, Seclusion, and Safety Devices" dated 06/28/2010 revealed, "POLICY:...The type or technique of restraint or seclusion is the least restrictive intervention that is effective to protect the patient, a staff member or others from harm. Restraints...are used in a manner that attempts to prevent harm, physical discomfort, embarrassment, or pain to the patient....DEFINITIONS: 1. RESTRAINT - A manual method, physical or mechanical device, material or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely....5. THERAPEUTIC HOLD - The brief physical holding of a patient in a manner that restricts his/her movement for the purpose of calming or providing physical safety to the patient , other patients, staff members or others. A therapeutic hold is used only by individuals trained in therapeutic hold techniques, and only when less restrictive measures have been attempted and have been determined to be ineffective. 6. FORENSIC RESTRAINTS - A locking restraint required by legal authorities when a person needs to be restrained to provide for safety or detention by legal authorities for legal reasons when that person is in custody of legal authorities or is under arrest/police hold in accordance with Federal and State laws and regulations....Forensic restraint mechanisms (...handcuffs,...)are not health care restraint interventions and are not applied by the staff of (Name of Hospital)....PROCEDURES:....2. TRAINING: Hospital staff involved in meeting the patient's needs are educated upon hire before they participate in the use of seclusion/restraint and annually thereafter. Training can be completed via didactic class or online self-study with successful completion of a post-test and competency. Hospital staff includes personnel from the following areas: Nursing,...Security,....Training Requirements Include: a. The underlying causes of threatening behavior. b. Less restrictive alternative. c. Proper and safe application/removal...of restraints. d. Monitoring patient's physical/psychological status....7. INITIATION & ASSESSMENT: A qualified licensed staff member with established competencies may initiate seclusion or apply restraint. Assessment of the patient who has new onset or worsening of confusion/agitation is done by an RN (registered nurse) prior to or within 30 minutes of application of a restraint....11. RESTRAINT/SECLUSION MONITORING:...Behavioral Seclusion/Restraint: Staff provides continuous face-to-face observation of the patient in rigid limb restraint(s) and maintains documentation on the Restraint Flowsheet (excluding therapeutic holds less than 15 minutes) and on the Special Observation Flowsheet....At the initiation of seclusion or restraint, and every 15 minutes, a staff member monitors the patient with the intent to prevent harm and maintain well-being....15. DOCUMENTATION: Documentation in the patient's record is to indicate a clear progression in how techniques were implemented with less intrusive restrictive intervention attempted or considered prior to the introduction of more restrictive measures. Only hospital personnel, who have received training and demonstrated competency are to document information related to the use of restraints within the scope of their license. Each episode of restraint/seclusion use is recorded in the medical record. Documentation includes: a. The circumstances that led to their use; b. Consideration or failure of non-physical less restrictive interventions; c. Medical conditions or physical disability that would place the patient at greater risk....d. The rationale for the type of physical intervention selected; e. The type of restraint used,...vital signs, circulation to extremities,...patient response to treatment, patient rights, dignity and privacy maintained, and time released....g. Written orders for use; h. Behavior criteria for release...; i. Informing the patient of behavior criteria for release from restraint...; l. Injuries that are sustained and treatment received for these injuries; and m. Deaths...."

1. Closed record review for Patient #5 revealed a 27 year-old male with a history of schizophrenia presented to the Emergency Department (ED) via Emergency Medical Services (EMS) on 04/17/2011 at 1638. Review of EMS documentation prior to arrival to hospital revealed, "Patient presented to ems very anxious, paranoid actions and behavior. Family member advised that patient had stopped taking Risperdal (antipsychotic medication) when the packaging came in different form. Patient also been hearing voices with hallucination. Patient non violent at this present time but very quiet and with paranoid tendencies. Patient cooperated with ems to go to hospital." Record review revealed upon arrival the patient was placed in Room 65 (within the locked psychiatric area of the ED). Review of triage nursing assessment at 1645 revealed, "Chief Complaint: Not taking medications." Review of nurse's notes revealed, "ER Physician Eval....Completed at: 04/17/2011 16:50 by: (Physician #1 - ED physician) evaluate patient." Review of nurse's notes at 1707 revealed, "Patient calm cooperative, no respiratory distress, pt (patient) ambulatory to bathroom gait steady...." Record review revealed RN #2 completed a psychiatric nursing evaluation of the patient at 1720. Review of RN #2's psychiatric assessment revealed, "Pt not sure why he is here. Confused. Paranoid + restless. Pacing around room. Said he had an outburst at home. Slow to respond to questions. Denies SI/HI (suicidal/homicidal ideations) + hallucinations. Angry at his mother....appears to be responding to internal stimuli....Lives c (with) mother....Drinks occasionally. ) (no - denies) drugs. Got upset. Had an outburst - taking medication...." Record review revealed at 1751 Physician #1 ordered a psychiatric evaluation and psychiatric precautions. Review of nurse's notes at 1758 revealed, "Psychiatric Precautions....pt . denies homicidal idealations, pt denies suicidal idealations...calm and cooperative, makes eye contact when communicating, alert and oriented X 3. Assessment: cooperative at this time. Interventions: Clothing removed, initiate psych packet and armband." Record review revealed Physician #2 (psychiatrist) evaluated the patient. Review of Physician #2's orders at 1842 revealed, "Medication Orders: Risperdal M-tab 2 mg (milligrams) Note: give 4 mg po (by mouth) now." Review of RN #2's notes at 1845 revealed, "(Physician #2) completed evaluation. Pt to be diverted to 1st accepting facility. IVC (involuntary commitment) papers initiated at 1845. Primary nurse and security made aware). Record review revealed documentation at 1850 the patient was administered Risperdal M-tab 4 mg by mouth. Record review revealed documentation at 1910 RN #1 assumed care of the patient. Review of RN #1's note at 1929 revealed, "Assumed patient care. Patient awake and alert, breathing even and unlabored. Patient stares at RN, nonverbal. No response to questions or requests. Patient is INVOL(untary)." Review of RN #1's note at 1951 revealed, "Patient more verbal at this time, answering questions. Patient requested water; provided. patient continues to refuse to change into gown." Review of RN #1's note at 2017 revealed, "Patient continued to refuse gown, now stating ' I want my momma. I'm not putting on no mother (expletive) gown'. Patient more active in room, pacing. Patient multiple trips back and forth to bathroom; not following directions of security or nurse. CPO (Company Police Officer) and security to bedside; patient medicated." Record review revealed documentation at 2018 the patient was administered Ativan (anti-anxiety medication) 2 mg and and Geodon (antipsychotic medication) 20 mg via intramuscular injection (IM) per Physician #2's orders. Review of RN #1's note at 2053 revealed, "Patient refusing labs and urine at this time; continues to appear agitated and paces in room at times. Patient now more lucid asking where is and how he got here. Patient reoriented." Review of RN #1's note at 2110 revealed, "Patient pacing in hallway, appears to becoming more agitated. Refusing to stay in room, becoming aggressive with staff. (RN #2) from Psych ED aware of patients increasing agitation; will inform (Physician #2)." Review of RN #1's note at 2120 revealed, "Patient now states he is leaving, attempting to walk to double doors. When patient informed that he must stay in room he became very angry. States 'I need some water'. Patient then picks up water and proceeds to pour water on all staff member. Patient instructed to stop by CPO and water taken from patient. Patient then attempts to leave room and begins to push and punch staff. Patient instructed to stop, refused. At this time patient was restrained by CPO and security. This RN then left area to inform Psychiatrist of situation. Upon returning to Psych area security states that patient has stopped resisting. When patient was moved to stretcher he was noted to have agonal respirations. Patient moved to resus(citation) room at this time." Review of RN #1's note at 2125 revealed, "Patient was being bagged with BVM (bag-valve mask). Upon arrival to resus room patient was pulseless, asystole on monitor; CPR (cardiopulmonary resuscitation) started." Review of RN #1's note at 2217 revealed, "Resuscitation attempts unsuccessful; efforts stopped. TOD (time of death) 2211." Review of RN #1's note at 0141 revealed, "Addendum to documentation charted at 2120. --As security was transferring patient to stretcher rigid restraints were being placed on limbs. Limb devices were placed around ankles and wrists, but at not time were they secured to stretcher/bed. Patient was not restrained with the limb devices at any point." Review of Physician #2's note dictated on 04/18/2011 at 0136 revealed, "HISTORY OF PRESENT ILLNESS....has a history of schizophrenia. He was actually discharged from the emergency department by this physician about a week ago. At that time, he was paranoid about a new form of the Risperdal M-Tab; however, at that time he took his medication and agreed to continue to take his medication, stayed overnight, and was reasonable. He reports that over the last week he has not taken his medication for about 4 days....He says his mother is out to get him; his mother is trying to get rid of him because of some kind of money....Although the patient was having a great (deal) of trouble attending and concentrating, he did report that he would stay in the hospital for treatment and agreed to taking his medication, which he did without any difficulty....He was involuntarily committed because of his paranoia, delusions, and his not taking medications....He became agitated around 8 p.m. and he received 20 mg of the Geodon IM and 2 mg of Ativan IM. This physician was with other patients actually at the time this was happening and he received the medication. He was not compliant with taking his clothes off or letting blood draws happen. It appears that about one-quarter past the hour the patient became more agitated after initially calming down. He was very thirsty. He was drinking some water and then he threw the water either at someone or on the floor and then started to be verbally abusive. He told the officer, 'Let's go,' and evidently took a swing. He was restrained at that period of time. He was on the ground being held by a number of nurses and CPO and so forth. Approximately five minutes into the incident, he urinated on himself and started breathing in erratic way. He was brought up to the gurney where a nurse recognized that he was not breathing appropriately and wanted him to go to the resuscitation room and resuscitation started. The whole incident happened over about an 8 minute period of time. After the code was run the patient expired. The patient's mother reports that, in fact, the patient has been compliant with his medication for the past week. She has been giving it to him....and...has watched him take the mediation every day. She reports that he jumped out a two-story window today and there was no indication in the E-stat (medical record) or any report that this patient suffered a two-story fall. The patient's mother reports that there were indentations in the ground where his feet landed from this jump....The patient's mother reported that he was confused at the scene and did not necessarily know who she was, and could not remember what was going on. Once again, none of that information was available at the time the patient was evaluated....There is no known history of drug or alcohol use....LABORATORY AND DIAGNOSTIC DATA 1. Toxicology screen negative...." Record review revealed patient's body was sent to the Office of the Chief Medical Examiner for autopsy. Review of the "Report of Autopsy Examination" dated 09/06/2011 and signed by a physician from the Medical Examiner's office revealed, "Date of Exam 04/18/2011....SUMMARY AND INTERPRETATION....He was being involuntarily committed and was at the local hospital when his death occurred. He was agitated and attempting to leave his room when he was physically restrained by multiple individuals. Video of the events show one person placing an arm around his neck prior to him being taken to the ground. The neck restraint appears to be maintained as several other individuals restrain his body. His respiratory function would have been further compromised if overlay occurred on the chest and/or abdomen. The decedent appears unresponsive immediately following the restraint. Significant findings at autopsy include small, multifocal and thin subarachnoid hemorrhages, hemorrhages in the tongue and laryngeal mucosa and chronic active hepatitis of unknown etiology. Toxicology studies are positive for therapeutic concentrations of Risperidone (Risperdol) in aorta blood. Benzodiazepines, cocaine, ethanol, opiates, organic bases, ziprasidone and haloperidol are not detected. Based on the history and investigative findings, it is my opinion that the cause of death in this case is asphyxia due to restraint."

Review on 10/18/2011 at 1130 and on 10/20/2011 at 1130 of video taped footage of the Psychiatric Area of the ED dated 04/17/2011 and beginning at 2113 revealed two different views were recorded. Review on 10/18/2011 with a staff member from the ED (to identify staff in footage) and legal department staff revealed the cameral angle from down the hall that showed Room 65 on the right side of the hall. Review on 10/20/2011 with the Vice President of Nursing and legal department staff revealed the camera angle was from down the hall and looking directly into Room 65. Review of the footage revealed the following events at the noted times:
? 21:13:00 - Patient #5 in room with lights off. CPO #1 and CPO #2 go into patient's room and turn lights on. One Security Officer (SO) in room and another SO at the patient's doorway looking into room (SO #1 and SO #2). RN #1 and RN #2 outside of and looking into room.
? 21:13:14 - RN #1 goes into room. SO #1 and SO #2 in room and CPO #1 and CPO #2 standing in doorway of room. Patient not in view.
? 21:13:26 - Patient walks into view in front of bed (which is against the back wall). All staff looking at patient. Patient sits on bed.
? 21:13:53 - Patient stands up off of bed with a cup in his hand.
? 21:14:16 - Patient throws water from cup onto a Security Officer (unable to determine which one). CPO reaches for cup.
? 21:14:22 - RN #1 goes out of room and out of view. RN #2 in doorway looking into room. Patient not in view, but can see 2 Security Officers and 1 CPO in room (other CPO is in room out of view).
? 21:14:34 - Patient stands in view with CPO #1 in front of him. Patient then sits in a chair to left side of room. The 2 Security Officers are now outside of the room, one of them wipes off his glasses.
? 21:14:54 - RN #1 stands in doorway of room.
? 21:14:55 - Patient stands up. CPO #1 standing in front of patient and CPO #2 on the right side of room. RN #2 walks away from room and out of view.
? 21:15:15 - Security Officer in hall wipes his pants off with a towel and RN #1 steps away from patient's door and helps him. Patient visible standing in room with CPO #1 standing in front of him.
? 21:15:21 - Patient moves towards door and CPO #1 moves in front of him (between patient and door). SO #1 and SO #2 outside of and looking into room. RN #1 walks towards room while wiping her shirt with a towel.
? 21:15:22 - CPO #2 walks towards patient (from right side of room) with arms reached out towards patient.
? 21:15:23 - SO #1 and SO #2 move into the patient's doorway. Patient is facing doorway with CPO #1 on his right side and CPO #2 on his left side (both CPOs positioned towards the front of the patient).
? 21:15:25 - RN #1 turns away from the patient's room and walks down the hall. The 2 CPOs are holding the patient's arms, one on each side.
? 21:15:26 - Patient lifts up slightly and sits on bed (CPOs still beside of and with hands on the patient).
? 21:15:28 - RN #1 looks over shoulder then turns around and faces the patient's room. SO #1 and SO #2 head into room. CPO #1 leans down towards bed. CPO #2 not in view.
? 21:15:29 - RN #1 turns back away from and continues to walk away from room. Patient is visible standing and facing towards the right side of the room. CPO #1 goes behind the patient. CPO #1 lifts his right arm out with elbow bent and moves it towards the patient.
? 21:15:30 - CPO #1's arm not visible. CPO #1 is leaning forward or bending down. Patient not visible. SO #1 and SO #2 in doorway looking in. CPO #1 and patient go backwards (towards left side of room) together. CPO #2 comes into view with in front of patient with his arms extended, but hands not visible. RN #1 looks back towards room again, then turns and continues to walk away from room.
? 21:15:31 - Patient's right hand is in the doorway, holding onto the door jam. The 2 Security Officers are still in the doorway. Both CPOs face the doorway as they and the patient are going down.
? 21:15:32 - Patient down and out of view. CPO #1 (who was behind patient) is not visible. CPO #2 in front of patient and leaning towards floor. SO #1 and SO #2 enter room and are on the right side of the patient, with their backs towards the camera. The Security Officer closest to the patient's legs is leaning down.
? 21:15:35 - CPO #2 leaning down towards patient and out of view. Both Security Officers leaning towards patient, the one near the top of the patient is standing and the one near the patient's legs is leaning towards patient with his (officers) legs extended to the side.
? 21:15:38 - CPO #1 and patient remain out of view. CPO #2 and both Security Officers are leaning towards the left, over the patient.
? 21:15:44 - The Two Security Officers stand, but still lean over the patient.
? 21:15:46 - One of the Security Officers goes around to the patient's other (left) side.
? 21:15:49 - CPO #1 and patient remain out of view. CPO #2 appears to be on the patient's legs.
? 21:15:52 - CPO #2 is up on his toes with his legs extended behind him. The top of his body is positioned towards the patient, but the view is blocked by the back of the Security Officer that is positioned on the patient's right side.
? 21:15:53 - Patient's right leg goes up, then down. Security Officer on right side of patient appears to hold it.
? 21:16:03 to 21:16:12 - The footage jumps and there is no footage available during this period of time.
? 21:16:12 - The Security Officer on the right side of the patient and CPO #2, now located near the patient's legs on the right side, are both leaning over the patient with their backs to the door. No one else in the room is visible.
? 21:16:27 - Security Officers and CPOs visible on floor, no apparent struggling at this point.
? 21:16:30 - RN #2 and RN #3 (a male psychiatric ED nurse) go to the doorway of the patient's room and look in.
? 21:16:35 - RN #2 goes into room
? 21:16:38 - RN #3 goes into room
? 21:16:42 - RN #3 leans toward patient's feet. CPO #1 now visible and near the top of and to the right of the patient. A Security Officer is visible on each side of the patient.
? 21:16:48 - RN #1 walks to door, drops restraints on the floor in the hall near the door, and turns and walks away from room. RN #2 goes into room and goes to the left side of the room.
? 21:16:54 - Both Security Officers now standing and leaning over patient. CPO #1 is near the top of the patient and is leaning over patient, either on his knees or with his legs extended.
? 21:16:55 - RN #2 leaning over the patient, near his head and to the left of CPO #1, then standing up.
? 21:16:59 - 2 EMS staff and ED Tech(nician) #1 arrive and enter into room.
? 21:17:02 - 1 of the EMS staff goes towards the patient's head and looks down.
? 21:17:04 - RN #2 comes out of room.
? 21:17:10 - 2 EMS staff and ED Tech #1 come out of room.
? 21:17:22 - Licensed Practical Nurse (LPN) #1 (an ED nurse) enters room, followed by 1 EMS staff and ED Tech #1. RN #1 is standing in the doorway with restraints in her hand.
? 21:17:35 - Second EMS staff goes into room.
? 21:17:41 - A staff member inside room (unable to determine which one) is seen putting a sheet on the bed.
? 21:17:48 - Security Officers and other staff are standing looking towards the patient on the floor.
? 21:17:50 - Several staff (unable to determine who or how many) lift the patient from the floor to the bed.
? 21:17:52 - Patient is on bed. Staff, including SO #1, SO #2, and CPO #2, surround the patient. CPO #1 is standing in the doorway.
? 21:17:54 - RN #1 goes into room with restraints in hand.
? 21:17:58 - CPO #1 goes out of room and rubs his head.
? 21:18:30 - Physician #2 (psychiatrist) walks towards room and stops and talks to CPO #1 in the hall on the way.
? 21:18:37 - Physician #2 stands in patient's doorway, leans on doorway, and looks into room. (Does not go into room).
? 21:18:42 - RN #4 (psychiatric nurse) walks towards room and talks to CPO #1 in hall.
? 21:18:49 - RN #3 is standing in room and looking down.
? 21:18:55 - Physician #2 walks away from room. 1 EMS staff exits room. RN #3 mops floor with towel.
? 21:19:02 - Patient is seen laying on bed. Patient is not moving and his clothes are off (can see naked right side).
? 21:19:08 - RN #2 exits room and talks to Physician #2 in hall.
? 21:19:34 - RN #3 exits room and talks to Physician #2 in hall. Other EMS staff exits room. RN #2 goes back into room.
? 21:19:49 - RN #3 and CPO #1 go into room.
? 21:19:56 - RN #3 exits room. RN #1, RN #2, and LPN #1 are in room near the patient's head. Patient is not moving.
? 21:20:15 - RN #3 goes into room with BP (blood pressure) machine.
? 21:20:36 - Security Supervisor goes to and looks into room.
? 21:23:26 - Someone takes BP cuff off of patient's arm.
? 21:23:33 - Staff roll patient out of room on bed. He is naked with a sheet laying over his groin. Restraints are visible on his ankles (cannot see his clearly see his wrists). Patient is not moving.

Interview on 10/19/2011 at 1100 with Security Officer (SO) #1 revealed the officer was posted in the psychiatric area of the ED on 04/17/2011 from 4 PM to Midnight. Interview revealed when Patient #5 arrived to Room 65 "staff decided he didn't need to change (into gown) right away. That was their call....I wanded him". Interview revealed SO #2 walked through the psychiatric area of the ED to see if SO #1 needed any assistance. Further interview revealed, "He (The patient) was calm at first. The longer he sat he got more agitated. (SO #2) decided to stay with me due to his agitation. We don't usually let patients walk in the halls (in the psychiatric area of the ED), but in this occasion I let him walk in the hall. It seemed to calm him. He went back and forth to the bathroom and his room. We kept our distance and kept an eye on him. He didn't say a lot. He had this white stuff around the outside of his mouth. We told the nurse about it because we have seen patients that have been doing spice or something (illicit substances) like that. Its just an observation we had noticed in the past. He was muttering stuff like he wanted to go home." Interview revealed the patient became more agitated and began hitting the bed and wall. Interview revealed SO #1 called Company Police for assistance once before the end of the 0700-1900 shift and CPO #2 came to psychiatric area. Interview revealed, "They cam and hung around for a little bit and then left." Interview revealed, "I think he was given a pill before (dayshift nurse) left at 7 PM. It seemed like it made him worse. He really started to hit the walls and bed. (He had) muttered talking, not making any sense. He would come out (of his room) a little bit and we'd ask him to go back and he would eventually go back. (RN #1) came on and I told her about his behavior. I don't remember if she went in to see the patient. I called Company Police again and (CPO #2) came and saw the patients behavior and called (CPO #1) to come." Interview revealed at this point the patient's behavior had escalated and "it looked like he was about to act out severely". Interview revealed, "I think the nurse came and tried to speak to him. He didn't calm down. The two Company Policy Officers came into his room and told me and (SO #2) to step back. They took charge." Interview revealed at that point the two security officers went out of the patient's room and stood in the doorway. Interview revealed, "They (The CPOs) told the patient medical staff needed to take care of him, take blood or whatever. He (The patient) went at (CPO #1), swung and knocked (CPO #1) against the wall. (CPO #1) and (CPO #2) got him to the ground....I didn't see anyone grab his neck or shoulders, basically just his legs....(When the patient was on the ground) I grabbed his legs and then moved to his arm, I think on the right side. I think the Company Police Officers were on his arms and upper body. As far as I could tell they were leaning on his chest....They had their back to us, so I don't remember if I could see his (the patient's) face or neck." Further interview revealed the officer thought he had to call, by waving his arm so as to be seen on video monitor at the ED desk, to get a nurse in the room. Interview revealed the officer thought someone had pushed the panic button (initiated an emergency response) because "so many" staff showed up. Further interview revealed, "We moved him to the bed. He was still struggling and urinating on himself (when on the floor and the bed). He was moving his arms and legs, trying to get up. He was muttering some stuff....They gave him some shots and tried to put restraints on because he was fighting pretty hard. Before putting restraints on him, they tried to get his clothes off and put a gown on him. I think they got a gown on him, but I'm not sure. Restraints were placed on his arms and legs by medical staff, I'm not sure who...a couple of females and a male. Sometime during that point he quit moving a lot, because they had given him the shots, it usually works pretty quick. That's when the nurse noticed there seems to be something wrong, seems like he's not breathing. She told (RN #2) to go get the bag (BVM). A male nurse checked the pulse and said it was weak. They got him out of there and to the resuscitation room."

Interview was requested with and declined by CPO #1. Review of hospital investigation documents revealed documentation of an interview on 05/19/2011 of CPO #1 by Root Cause Analysis team members. Review of the interview revealed CPO #1 first responded on 04/17/2011 at 2000 and talked with the patient, who appeared to be afraid, and held the patient for a shot. Review of the interview revealed at 2100 CPO #1 was called back to the psychiatric area, at which time the patient was walking out of his room. Review of the interview revealed the patient was completely different and was more agitated and asking for water. Review revealed the patient had white chalk around his mouth that the CPO didn't notice previously. Review revealed the patient threw water and CPO #1 grabbed hold of him. Review revealed the patient grabbed the CPO's badge, and the CPO grabbed his wrist to get him to release it. Review revealed the patient grabbed the badge again and tried to push the CPO out of the room. Review revealed, "Officer (CPO #1) slipped, pulled patient on top of him with shirt. Hit head on wall. (CPO #1) thinking about rolling fingers under jaw, can't remember if he did it or not." Review revealed Security Officers held the patient's arms and legs. Review revealed, "(CPO #1) got out from under him, laid on his (the patient's) shoulder. Review revealed, when CPO #1 was asked if anything about this case concerned him, he responded the patient had received only one injection, that had more medications than usual in the syringe, and nurses don't know how to apply leather restraints, officers used to apply leathers, now they don't. Review revealed, when CPO #1 was asked who has authority to place a patient in physical restraints, he responded officers not allowed, nurses don't know how. Review revealed, when CPO #1 was asked what he does when a patient starts to escalate and how he was trained in de-escalating patients, his response was documented by the interviewer as "Put arms across jaw to keep his head turned away. Patient blubbering, blowing foam and spit. Patient quit moving. Patient still breathing. Moved to stretcher. Put restraints on legs. Moved to arms and LPN noticed he wasn't breathing. Patient arched back and took one big breath. Training: soft hands - pain compliance; no marks left but cause pain; wrist lock; and nerve under jaw. hard hands - punches".

Personnel file review for CPO #1 revealed no documentation the CPO had completed NCI (Nonviolent Crisis Intervention - training program that teaches deescalation and therapeutic patient hold techniques). File review revealed no documentation the CPO had received hospital based restraint training.

Interview was requested with and declined by CPO #2. Review of hospital investigation documents revealed documentation of an interview on 05/12/2011 of CPO #2 by Root Cause Analysis team members. Review of the interview revealed CPO #2 received a call from SO #1, saying they were trying to get the patient in a gown, at around 2000 on 04/17/2011. Review revealed CPO #2 responded and stayed with the patient, SO #1, and SO #2. Review revealed after about 1 hour the patient kept asking where he was where his mother was. Review revealed CPO #2 said his sixth sense told him to stay in the room with the patient. Review revealed CPO #2 said he thought several people need to stay. Review of interview revealed, "They kept telling patient to stay in room, but he kept going to the bathroom and as the hour progressed he got more and more agitated. They heard him strike the wall one time. They called (CPO #1) to ask him to come to patient's room. Patient sat on bed (not sure if voluntary or if they asked him to). Patient asked for some water, which (CPO #1) gave him and the patient 'sprinkled ' water on them. (CPO #1) told him to stop and he did. Then they had to tell him again. (CPO #1) was standing directly in front of patient. 2 security guards standing behind them in hallway. Patient put his hands on (CPO #1). States as a natural reaction to protect themselves (CPO #1) got behind him and had him by his midsection. Both (CPO #1) and patient fell against wall and then to the floor. Then the 2 security guards joined in to help. (SO #2) had patients left arm. (SO #1) had (unable to read). (CPO #2) in front of him. Brought patient under control through physical restraint. Patient put on the bed. When on bed, (CPO #2) restrained left arm, (CPO #1) his feet and medical staff attende

Based on policy review, medical record review, video taped footage review, staff interview, personnel file review, and hospital investigation document review, the hospital failed to ensure physical restraint was implemented in accordance with safe and appropriate techniques for 2 of 3 sampled patients that were physically restrained by staff (Patients #5 and #2).

The findings include:

Review of hospital policy entitled "Restraints, Seclusion, and Safety Devices" dated 06/28/2010 revealed, "POLICY:...The type or technique of restraint or seclusion is the least restrictive intervention that is effective to protect the patient, a staff member or others from harm. Restraints...are used in a manner that attempts to prevent harm, physical discomfort, embarrassment, or pain to the patient....DEFINITIONS: 1. RESTRAINT - A manual method, physical or mechanical device, material or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely....5. THERAPEUTIC HOLD - The brief physical holding of a patient in a manner that restricts his/her movement for the purpose of calming or providing physical safety to the patient , other patients, staff members or others. A therapeutic hold is used only by individuals trained in therapeutic hold techniques, and only when less restrictive measures have been attempted and have been determined to be ineffective. 6. FORENSIC RESTRAINTS - A locking restraint required by legal authorities when a person needs to be restrained to provide for safety or detention by legal authorities for legal reasons when that person is in custody of legal authorities or is under arrest/police hold in accordance with Federal and State laws and regulations....Forensic restraint mechanisms (...handcuffs,...)are not health care restraint interventions and are not applied by the staff of (Name of Hospital)....PROCEDURES:....2. TRAINING: Hospital staff involved in meeting the patient's needs are educated upon hire before they participate in the use of seclusion/restraint and annually thereafter. Training can be completed via didactic class or online self-study with successful completion of a post-test and competency. Hospital staff includes personnel from the following areas: Nursing,...Security,....Training Requirements Include: a. The underlying causes of threatening behavior. b. Less restrictive alternative. c. Proper and safe application/removal...of restraints. d. Monitoring patient's physical/psychological status....7. INITIATION & ASSESSMENT: A qualified licensed staff member with established competencies may initiate seclusion or apply restraint. Assessment of the patient who has new onset or worsening of confusion/agitation is done by an RN (registered nurse) prior to or within 30 minutes of application of a restraint....11. RESTRAINT/SECLUSION MONITORING:...Behavioral Seclusion/Restraint: Staff provides continuous face-to-face observation of the patient in rigid limb restraint(s) and maintains documentation on the Restraint Flowsheet (excluding therapeutic holds less than 15 minutes) and on the Special Observation Flowsheet....At the initiation of seclusion or restraint, and every 15 minutes, a staff member monitors the patient with the intent to prevent harm and maintain well-being....15. DOCUMENTATION: Documentation in the patient's record is to indicate a clear progression in how techniques were implemented with less intrusive restrictive intervention attempted or considered prior to the introduction of more restrictive measures. Only hospital personnel, who have received training and demonstrated competency are to document information related to the use of restraints within the scope of their license. Each episode of restraint/seclusion use is recorded in the medical record. Documentation includes: a. The circumstances that led to their use; b. Consideration or failure of non-physical less restrictive interventions; c. Medical conditions or physical disability that would place the patient at greater risk....d. The rationale for the type of physical intervention selected; e. The type of restraint used,...vital signs, circulation to extremities,...patient response to treatment, patient rights, dignity and privacy maintained, and time released....g. Written orders for use; h. Behavior criteria for release...; i. Informing the patient of behavior criteria for release from restraint...; l. Injuries that are sustained and treatment received for these injuries; and m. Deaths...."

1. Closed record review for Patient #5 revealed a 27 year-old male with a history of schizophrenia presented to the Emergency Department (ED) via Emergency Medical Services (EMS) on 04/17/2011 at 1638. Review of EMS documentation prior to arrival to hospital revealed, "Patient presented to ems very anxious, paranoid actions and behavior. Family member advised that patient had stopped taking Risperdal (antipsychotic medication) when the packaging came in different form. Patient also been hearing voices with hallucination. Patient non violent at this present time but very quiet and with paranoid tendencies. Patient cooperated with ems to go to hospital." Record review revealed upon arrival the patient was placed in Room 65 (within the locked psychiatric area of the ED). Review of triage nursing assessment at 1645 revealed, "Chief Complaint: Not taking medications." Review of nurse's notes revealed, "ER Physician Eval....Completed at: 04/17/2011 16:50 by: (Physician #1 - ED physician) evaluate patient." Review of nurse's notes at 1707 revealed, "Patient calm cooperative, no respiratory distress, pt (patient) ambulatory to bathroom gait steady...." Record review revealed RN #2 completed a psychiatric nursing evaluation of the patient at 1720. Review of RN #2's psychiatric assessment revealed, "Pt not sure why he is here. Confused. Paranoid + restless. Pacing around room. Said he had an outburst at home. Slow to respond to questions. Denies SI/HI (suicidal/homicidal ideations) + hallucinations. Angry at his mother....appears to be responding to internal stimuli....Lives c (with) mother....Drinks occasionally. ) (no - denies) drugs. Got upset. Had an outburst - taking medication...." Record review revealed at 1751 Physician #1 ordered a psychiatric evaluation and psychiatric precautions. Review of nurse's notes at 1758 revealed, "Psychiatric Precautions....pt . denies homicidal idealations, pt denies suicidal idealations...calm and cooperative, makes eye contact when communicating, alert and oriented X 3. Assessment: cooperative at this time. Interventions: Clothing removed, initiate psych packet and armband." Record review revealed Physician #2 (psychiatrist) evaluated the patient. Review of Physician #2's orders at 1842 revealed, "Medication Orders: Risperdal M-tab 2 mg (milligrams) Note: give 4 mg po (by mouth) now." Review of RN #2's notes at 1845 revealed, "(Physician #2) completed evaluation. Pt to be diverted to 1st accepting facility. IVC (involuntary commitment) papers initiated at 1845. Primary nurse and security made aware). Record review revealed documentation at 1850 the patient was administered Risperdal M-tab 4 mg by mouth. Record review revealed documentation at 1910 RN #1 assumed care of the patient. Review of RN #1's note at 1929 revealed, "Assumed patient care. Patient awake and alert, breathing even and unlabored. Patient stares at RN, nonverbal. No response to questions or requests. Patient is INVOL(untary)." Review of RN #1's note at 1951 revealed, "Patient more verbal at this time, answering questions. Patient requested water; provided. patient continues to refuse to change into gown." Review of RN #1's note at 2017 revealed, "Patient continued to refuse gown, now stating ' I want my momma. I'm not putting on no mother (expletive) gown'. Patient more active in room, pacing. Patient multiple trips back and forth to bathroom; not following directions of security or nurse. CPO (Company Police Officer) and security to bedside; patient medicated." Record review revealed documentation at 2018 the patient was administered Ativan (anti-anxiety medication) 2 mg and and Geodon (antipsychotic medication) 20 mg via intramuscular injection (IM) per Physician #2's orders. Review of RN #1's note at 2053 revealed, "Patient refusing labs and urine at this time; continues to appear agitated and paces in room at times. Patient now more lucid asking where is and how he got here. Patient reoriented." Review of RN #1's note at 2110 revealed, "Patient pacing in hallway, appears to becoming more agitated. Refusing to stay in room, becoming aggressive with staff. (RN #2) from Psych ED aware of patients increasing agitation; will inform (Physician #2)." Review of RN #1's note at 2120 revealed, "Patient now states he is leaving, attempting to walk to double doors. When patient informed that he must stay in room he became very angry. States 'I need some water'. Patient then picks up water and proceeds to pour water on all staff member. Patient instructed to stop by CPO and water taken from patient. Patient then attempts to leave room and begins to push and punch staff. Patient instructed to stop, refused. At this time patient was restrained by CPO and security. This RN then left area to inform Psychiatrist of situation. Upon returning to Psych area security states that patient has stopped resisting. When patient was moved to stretcher he was noted to have agonal respirations. Patient moved to resus(citation) room at this time." Review of RN #1's note at 2125 revealed, "Patient was being bagged with BVM (bag-valve mask). Upon arrival to resus room patient was pulseless, asystole on monitor; CPR (cardiopulmonary resuscitation) started." Review of RN #1's note at 2217 revealed, "Resuscitation attempts unsuccessful; efforts stopped. TOD (time of death) 2211." Review of RN #1's note at 0141 revealed, "Addendum to documentation charted at 2120. --As security was transferring patient to stretcher rigid restraints were being placed on limbs. Limb devices were placed around ankles and wrists, but at not time were they secured to stretcher/bed. Patient was not restrained with the limb devices at any point." Review of Physician #2's note dictated on 04/18/2011 at 0136 revealed, "HISTORY OF PRESENT ILLNESS....has a history of schizophrenia. He was actually discharged from the emergency department by this physician about a week ago. At that time, he was paranoid about a new form of the Risperdal M-Tab; however, at that time he took his medication and agreed to continue to take his medication, stayed overnight, and was reasonable. He reports that over the last week he has not taken his medication for about 4 days....He says his mother is out to get him; his mother is trying to get rid of him because of some kind of money....Although the patient was having a great (deal) of trouble attending and concentrating, he did report that he would stay in the hospital for treatment and agreed to taking his medication, which he did without any difficulty....He was involuntarily committed because of his paranoia, delusions, and his not taking medications....He became agitated around 8 p.m. and he received 20 mg of the Geodon IM and 2 mg of Ativan IM. This physician was with other patients actually at the time this was happening and he received the medication. He was not compliant with taking his clothes off or letting blood draws happen. It appears that about one-quarter past the hour the patient became more agitated after initially calming down. He was very thirsty. He was drinking some water and then he threw the water either at someone or on the floor and then started to be verbally abusive. He told the officer, 'Let's go,' and evidently took a swing. He was restrained at that period of time. He was on the ground being held by a number of nurses and CPO and so forth. Approximately five minutes into the incident, he urinated on himself and started breathing in erratic way. He was brought up to the gurney where a nurse recognized that he was not breathing appropriately and wanted him to go to the resuscitation room and resuscitation started. The whole incident happened over about an 8 minute period of time. After the code was run the patient expired. The patient's mother reports that, in fact, the patient has been compliant with his medication for the past week. She has been giving it to him....and...has watched him take the mediation every day. She reports that he jumped out a two-story window today and there was no indication in the E-stat (medical record) or any report that this patient suffered a two-story fall. The patient's mother reports that there were indentations in the ground where his feet landed from this jump....The patient's mother reported that he was confused at the scene and did not necessarily know who she was, and could not remember what was going on. Once again, none of that information was available at the time the patient was evaluated....There is no known history of drug or alcohol use....LABORATORY AND DIAGNOSTIC DATA 1. Toxicology screen negative...." Record review revealed patient's body was sent to the Office of the Chief Medical Examiner for autopsy. Review of the "Report of Autopsy Examination" dated 09/06/2011 and signed by a physician from the Medical Examiner's office revealed, "Date of Exam 04/18/2011....SUMMARY AND INTERPRETATION....He was being involuntarily committed and was at the local hospital when his death occurred. He was agitated and attempting to leave his room when he was physically restrained by multiple individuals. Video of the events show one person placing an arm around his neck prior to him being taken to the ground. The neck restraint appears to be maintained as several other individuals restrain his body. His respiratory function would have been further compromised if overlay occurred on the chest and/or abdomen. The decedent appears unresponsive immediately following the restraint. Significant findings at autopsy include small, multifocal and thin subarachnoid hemorrhages, hemorrhages in the tongue and laryngeal mucosa and chronic active hepatitis of unknown etiology. Toxicology studies are positive for therapeutic concentrations of Risperidone (Risperdol) in aorta blood. Benzodiazepines, cocaine, ethanol, opiates, organic bases, ziprasidone and haloperidol are not detected. Based on the history and investigative findings, it is my opinion that the cause of death in this case is asphyxia due to restraint."

Review on 10/18/2011 at 1130 and on 10/20/2011 at 1130 of video taped footage of the Psychiatric Area of the ED dated 04/17/2011 and beginning at 2113 revealed two different views were recorded. Review on 10/18/2011 with a staff member from the ED (to identify staff in footage) and legal department staff revealed the cameral angle from down the hall that showed Room 65 on the right side of the hall. Review on 10/20/2011 with the Vice President of Nursing and legal department staff revealed the camera angle was from down the hall and looking directly into Room 65. Review of the footage revealed the following events at the noted times:
? 21:13:00 - Patient #5 in room with lights off. CPO #1 and CPO #2 go into patient's room and turn lights on. One Security Officer (SO) in room and another SO at the patient's doorway looking into room (SO #1 and SO #2). RN #1 and RN #2 outside of and looking into room.
? 21:13:14 - RN #1 goes into room. SO #1 and SO #2 in room and CPO #1 and CPO #2 standing in doorway of room. Patient not in view.
? 21:13:26 - Patient walks into view in front of bed (which is against the back wall). All staff looking at patient. Patient sits on bed.
? 21:13:53 - Patient stands up off of bed with a cup in his hand.
? 21:14:16 - Patient throws water from cup onto a Security Officer (unable to determine which one). CPO reaches for cup.
? 21:14:22 - RN #1 goes out of room and out of view. RN #2 in doorway looking into room. Patient not in view, but can see 2 Security Officers and 1 CPO in room (other CPO is in room out of view).
? 21:14:34 - Patient stands in view with CPO #1 in front of him. Patient then sits in a chair to left side of room. The 2 Security Officers are now outside of the room, one of them wipes off his glasses.
? 21:14:54 - RN #1 stands in doorway of room.
? 21:14:55 - Patient stands up. CPO #1 standing in front of patient and CPO #2 on the right side of room. RN #2 walks away from room and out of view.
? 21:15:15 - Security Officer in hall wipes his pants off with a towel and RN #1 steps away from patient's door and helps him. Patient visible standing in room with CPO #1 standing in front of him.
? 21:15:21 - Patient moves towards door and CPO #1 moves in front of him (between patient and door). SO #1 and SO #2 outside of and looking into room. RN #1 walks towards room while wiping her shirt with a towel.
? 21:15:22 - CPO #2 walks towards patient (from right side of room) with arms reached out towards patient.
? 21:15:23 - SO #1 and SO #2 move into the patient's doorway. Patient is facing doorway with CPO #1 on his right side and CPO #2 on his left side (both CPOs positioned towards the front of the patient).
? 21:15:25 - RN #1 turns away from the patient's room and walks down the hall. The 2 CPOs are holding the patient's arms, one on each side.
? 21:15:26 - Patient lifts up slightly and sits on bed (CPOs still beside of and with hands on the patient).
? 21:15:28 - RN #1 looks over shoulder then turns around and faces the patient's room. SO #1 and SO #2 head into room. CPO #1 leans down towards bed. CPO #2 not in view.
? 21:15:29 - RN #1 turns back away from and continues to walk away from room. Patient is visible standing and facing towards the right side of the room. CPO #1 goes behind the patient. CPO #1 lifts his right arm out with elbow bent and moves it towards the patient.
? 21:15:30 - CPO #1's arm not visible. CPO #1 is leaning forward or bending down. Patient not visible. SO #1 and SO #2 in doorway looking in. CPO #1 and patient go backwards (towards left side of room) together. CPO #2 comes into view with in front of patient with his arms extended, but hands not visible. RN #1 looks back towards room again, then turns and continues to walk away from room.
? 21:15:31 - Patient's right hand is in the doorway, holding onto the door jam. The 2 Security Officers are still in the doorway. Both CPOs face the doorway as they and the patient are going down.
? 21:15:32 - Patient down and out of view. CPO #1 (who was behind patient) is not visible. CPO #2 in front of patient and leaning towards floor. SO #1 and SO #2 enter room and are on the right side of the patient, with their backs towards the camera. The Security Officer closest to the patient's legs is leaning down.
? 21:15:35 - CPO #2 leaning down towards patient and out of view. Both Security Officers leaning towards patient, the one near the top of the patient is standing and the one near the patient's legs is leaning towards patient with his (officers) legs extended to the side.
? 21:15:38 - CPO #1 and patient remain out of view. CPO #2 and both Security Officers are leaning towards the left, over the patient.
? 21:15:44 - The Two Security Officers stand, but still lean over the patient.
? 21:15:46 - One of the Security Officers goes around to the patient's other (left) side.
? 21:15:49 - CPO #1 and patient remain out of view. CPO #2 appears to be on the patient's legs.
? 21:15:52 - CPO #2 is up on his toes with his legs extended behind him. The top of his body is positioned towards the patient, but the view is blocked by the back of the Security Officer that is positioned on the patient's right side.
? 21:15:53 - Patient's right leg goes up, then down. Security Officer on right side of patient appears to hold it.
? 21:16:03 to 21:16:12 - The footage jumps and there is no footage available during this period of time.
? 21:16:12 - The Security Officer on the right side of the patient and CPO #2, now located near the patient's legs on the right side, are both leaning over the patient with their backs to the door. No one else in the room is visible.
? 21:16:27 - Security Officers and CPOs visible on floor, no apparent struggling at this point.
? 21:16:30 - RN #2 and RN #3 (a male psychiatric ED nurse) go to the doorway of the patient's room and look in.
? 21:16:35 - RN #2 goes into room
? 21:16:38 - RN #3 goes into room
? 21:16:42 - RN #3 leans toward patient's feet. CPO #1 now visible and near the top of and to the right of the patient. A Security Officer is visible on each side of the patient.
? 21:16:48 - RN #1 walks to door, drops restraints on the floor in the hall near the door, and turns and walks away from room. RN #2 goes into room and goes to the left side of the room.
? 21:16:54 - Both Security Officers now standing and leaning over patient. CPO #1 is near the top of the patient and is leaning over patient, either on his knees or with his legs extended.
? 21:16:55 - RN #2 leaning over the patient, near his head and to the left of CPO #1, then standing up.
? 21:16:59 - 2 EMS staff and ED Tech(nician) #1 arrive and enter into room.
? 21:17:02 - 1 of the EMS staff goes towards the patient's head and looks down.
? 21:17:04 - RN #2 comes out of room.
? 21:17:10 - 2 EMS staff and ED Tech #1 come out of room.
? 21:17:22 - Licensed Practical Nurse (LPN) #1 (an ED nurse) enters room, followed by 1 EMS staff and ED Tech #1. RN #1 is standing in the doorway with restraints in her hand.
? 21:17:35 - Second EMS staff goes into room.
? 21:17:41 - A staff member inside room (unable to determine which one) is seen putting a sheet on the bed.
? 21:17:48 - Security Officers and other staff are standing looking towards the patient on the floor.
? 21:17:50 - Several staff (unable to determine who or how many) lift the patient from the floor to the bed.
? 21:17:52 - Patient is on bed. Staff, including SO #1, SO #2, and CPO #2, surround the patient. CPO #1 is standing in the doorway.
? 21:17:54 - RN #1 goes into room with restraints in hand.
? 21:17:58 - CPO #1 goes out of room and rubs his head.
? 21:18:30 - Physician #2 (psychiatrist) walks towards room and stops and talks to CPO #1 in the hall on the way.
? 21:18:37 - Physician #2 stands in patient's doorway, leans on doorway, and looks into room. (Does not go into room).
? 21:18:42 - RN #4 (psychiatric nurse) walks towards room and talks to CPO #1 in hall.
? 21:18:49 - RN #3 is standing in room and looking down.
? 21:18:55 - Physician #2 walks away from room. 1 EMS staff exits room. RN #3 mops floor with towel.
? 21:19:02 - Patient is seen laying on bed. Patient is not moving and his clothes are off (can see naked right side).
? 21:19:08 - RN #2 exits room and talks to Physician #2 in hall.
? 21:19:34 - RN #3 exits room and talks to Physician #2 in hall. Other EMS staff exits room. RN #2 goes back into room.
? 21:19:49 - RN #3 and CPO #1 go into room.
? 21:19:56 - RN #3 exits room. RN #1, RN #2, and LPN #1 are in room near the patient's head. Patient is not moving.
? 21:20:15 - RN #3 goes into room with BP (blood pressure) machine.
? 21:20:36 - Security Supervisor goes to and looks into room.
? 21:23:26 - Someone takes BP cuff off of patient's arm.
? 21:23:33 - Staff roll patient out of room on bed. He is naked with a sheet laying over his groin. Restraints are visible on his ankles (cannot see his clearly see his wrists). Patient is not moving.

Interview on 10/19/2011 at 1100 with Security Officer (SO) #1 revealed the officer was posted in the psychiatric area of the ED on 04/17/2011 from 4 PM to Midnight. Interview revealed when Patient #5 arrived to Room 65 "staff decided he didn't need to change (into gown) right away. That was their call....I wanded him". Interview revealed SO #2 walked through the psychiatric area of the ED to see if SO #1 needed any assistance. Further interview revealed, "He (The patient) was calm at first. The longer he sat he got more agitated. (SO #2) decided to stay with me due to his agitation. We don't usually let patients walk in the halls (in the psychiatric area of the ED), but in this occasion I let him walk in the hall. It seemed to calm him. He went back and forth to the bathroom and his room. We kept our distance and kept an eye on him. He didn't say a lot. He had this white stuff around the outside of his mouth. We told the nurse about it because we have seen patients that have been doing spice or something (illicit substances) like that. Its just an observation we had noticed in the past. He was muttering stuff like he wanted to go home." Interview revealed the patient became more agitated and began hitting the bed and wall. Interview revealed SO #1 called Company Police for assistance once before the end of the 0700-1900 shift and CPO #2 came to psychiatric area. Interview revealed, "They came and hung around for a little bit and then left." Interview revealed, "I think he was given a pill before (dayshift nurse) left at 7 PM. It seemed like it made him worse. He really started to hit the walls and bed. (He had) muttered talking, not making any sense. He would come out (of his room) a little bit and we'd ask him to go back and he would eventually go back. (RN #1) came on and I told her about his behavior. I don't remember if she went in to see the patient. I called Company Police again and (CPO #2) came and saw the patient's behavior and called (CPO #1) to come." Interview revealed at this point the patient's behavior had escalated and "it looked like he was about to act out severely". Interview revealed, "I think the nurse came and tried to speak to him. He didn't calm down. The two Company Policy Officers came into his room and told me and (SO #2) to step back. They took charge." Interview revealed at that point the two security officers went out of the patient's room and stood in the doorway. Interview revealed, "They (The CPOs) told the patient medical staff needed to take care of him, take blood or whatever. He (The patient) went at (CPO #1), swung and knocked (CPO #1) against the wall. (CPO #1) and (CPO #2) got him to the ground....I didn't see anyone grab his neck or shoulders, basically just his legs....(When the patient was on the ground) I grabbed his legs and then moved to his arm, I think on the right side. I think the Company Police Officers were on his arms and upper body. As far as I could tell they were leaning on his chest....They had their back to us, so I don't remember if I could see his (the patient's) face or neck." Further interview revealed the officer thought he had to call, by waving his arm so as to be seen on video monitor at the ED desk, to get a nurse in the room. Interview revealed the officer thought someone had pushed the panic button (initiated an emergency response) because "so many" staff showed up. Further interview revealed, "We moved him to the bed. He was still struggling and urinating on himself (when on the floor and the bed). He was moving his arms and legs, trying to get up. He was muttering some stuff....They gave him some shots and tried to put restraints on because he was fighting pretty hard. Before putting restraints on him, they tried to get his clothes off and put a gown on him. I think they got a gown on him, but I'm not sure. Restraints were placed on his arms and legs by medical staff, I'm not sure who...a couple of females and a male. Sometime during that point he quit moving a lot, because they had given him the shots, it usually works pretty quick. That's when the nurse noticed there seems to be something wrong, seems like he's not breathing. She told (RN #2) to go get the bag (BVM). A male nurse checked the pulse and said it was weak. They got him out of there and to the resuscitation room."

Interview was requested with and declined by CPO #1. Review of hospital investigation documents revealed documentation of an interview on 05/19/2011 of CPO #1 by Root Cause Analysis team members. Review of the interview revealed CPO #1 first responded on 04/17/2011 at 2000 and talked with the patient, who appeared to be afraid, and held the patient for a shot. Review of the interview revealed at 2100 CPO #1 was called back to the psychiatric area, at which time the patient was walking out of his room. Review of the interview revealed the patient was completely different and was more agitated and asking for water. Review revealed the patient had white chalk around his mouth that the CPO didn't notice previously. Review revealed the patient threw water and CPO #1 grabbed hold of him. Review revealed the patient grabbed the CPO's badge, and the CPO grabbed his wrist to get him to release it. Review revealed the patient grabbed the badge again and tried to push the CPO out of the room. Review revealed, "Officer (CPO #1) slipped, pulled patient on top of him with shirt. Hit head on wall. (CPO #1) thinking about rolling fingers under jaw, can't remember if he did it or not." Review revealed Security Officers held the patient's arms and legs. Review revealed, "(CPO #1) got out from under him, laid on his (the patient's) shoulder. Review revealed, when CPO #1 was asked if anything about this case concerned him, he responded the patient had received only one injection, that had more medications than usual in the syringe, and nurses don't know how to apply leather restraints, officers used to apply leathers, now they don't. Review revealed, when CPO #1 was asked who has authority to place a patient in physical restraints, he responded officers not allowed, nurses don't know how. Review revealed, when CPO #1 was asked what he does when a patient starts to escalate and how he was trained in de-escalating patients, his response was documented by the interviewer as "Put arms across jaw to keep his head turned away. Patient blubbering, blowing foam and spit. Patient quit moving. Patient still breathing. Moved to stretcher. Put restraints on legs. Moved to arms and LPN noticed he wasn't breathing. Patient arched back and took one big breath. Training: soft hands - pain compliance; no marks left but cause pain; wrist lock; and nerve under jaw. hard hands - punches".

Personnel file review for CPO #1 revealed no documentation the CPO had completed NCI (Nonviolent Crisis Intervention training program that teaches deescalation and therapeutic patient hold techniques). File review revealed no documentation the CPO had received hospital based restraint training.

Interview was requested with and declined by CPO #2. Review of hospital investigation documents revealed documentation of an interview on 05/12/2011 of CPO #2 by Root Cause Analysis team members. Review of the interview revealed CPO #2 received a call from SO #1, saying they were trying to get the patient in a gown, at around 2000 on 04/17/2011. Review revealed CPO #2 responded and stayed with the patient, SO #1, and SO #2. Review revealed after about 1 hour the patient kept asking where he was where his mother was. Review revealed CPO #2 said his sixth sense told him to stay in the room with the patient. Review revealed CPO #2 said he thought several people need to stay. Review of interview revealed, "They kept telling patient to stay in room, but he kept going to the bathroom and as the hour progressed he got more and more agitated. They heard him strike the wall one time. The called (CPO #1) to ask him to come to patient's room. Patient sat on bed (not sure if voluntary or if they asked him to). Patient asked for some water, which (CPO #1) gave him and the patient 'sprinkled ' water on them. (CPO #1) told him to stop and he did. Then they had to tell him again. (CPO #1) was standing directly in front of patient. 2 security guards standing behind them in hallway. Patient put his hands on (CPO #1). States as a natural reaction to protect themselves (CPO #1) got behind him and had him by his mid-section. Both (CPO #1) and patient fell against wall and then to the floor. Then the 2 security guards joined in to help. (SO #2) had patients left arm. (SO #1) had (unable to read text). (CPO #2) in front of him. Brought patient under control through physical restraint. Patient put on the bed. When on bed, (CPO #2) restrained left arm, (CPO #1) his feet and medical staff attended patient. Heard them talk about patient's breathing and doctor was going to take him to the resuscitation

Based on policy review, medical record review, and staff interview, the hospital failed to ensure a physician's order for physical restraint for 3 of 3 sampled patients that were physically restrained by staff (Patients #5, #2, and #7).

The findings include:

Review of hospital policy entitled "Restraints, Seclusion, and Safety Devices" dated 06/28/2010 revealed, "POLICY:...The type or technique of restraint or seclusion is the least restrictive intervention that is effective to protect the patient, a staff member or others from harm. Restraints...are used in a manner that attempts to prevent harm, physical discomfort, embarrassment, or pain to the patient....DEFINITIONS: 1. RESTRAINT - A manual method, physical or mechanical device, material or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely...PROCEDURES:...8. TIME LIMITED ORDERS: A verbal or telephone order is obtained from the physician within 30 minutes of the placement of restraints...15. DOCUMENTATION:...Documentation includes:...g. Written orders for use..."

1. Closed record review for Patient #5 revealed a 27 year-old male with a history of schizophrenia presented to the Emergency Department (ED) via Emergency Medical Services (EMS) on 04/17/2011 at 1638. Review of triage nursing assessment at 1645 revealed, "Chief Complaint: Not taking medications." Review of RN #1's note at 2120 revealed, "Patient now states he is leaving, attempting to walk to double doors. When patient informed that he must stay in room he became very angry. States 'I need some water'. Patient then picks up water and proceeds to pour water on all staff member. Patient instructed to stop by CPO and water taken from patient. Patient then attempts to leave room and begins to push and punch staff. Patient instructed to stop, refused. At this time patient was restrained by CPO and security. This RN then left area to inform Psychiatrist of situation...." Review of Physician #2's note dictated on 04/18/2011 at 0136 revealed, "...He became agitated around 8 p.m. and he received 20 mg of the Geodon (anti-psychotic mediation) IM (intramuscularly) and 2 mg of Ativan (anti-anxiety medication) IM. This physician was with other patients actually at the time this was happening and he received the medication....It appears that about one-quarter past the hour the patient became more agitated after initially calming down....he threw the water either at someone or on the floor and then started to be verbally abusive. He told the officer, 'Let's go,' and evidently took a swing. He was restrained at that period of time. He was on the ground being held by a number of nurses and CPO and so forth...." Further record review revealed no documentation of a physician's order for restraint.

Interview on 10/19/2011 at 1215 with the Service Line Director of Emergency Services revealed a physical hold was a restraint and therefore required a physician's order. Interview revealed if the restraint is a physical hold that does not progress to mechanical restraint "I do not believe a physician's order is always obtained, because it is a rapid situation that deescalated". Interview revealed, "It is required to get an order and the physician should evaluate the patient within 1 hour." Further interview with the Director at 1400 confirmed there was no available documentation of a physician's order for the physical restraint of the patient on 04/17/2011.


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2. Closed medical record review for patient #2 revealed a 42 year old male presenting to the hospital's Emergency Department (ED) via Emergency Medical Services (EMS) on 04/24/2011 at 0203 involuntarily committed (IVC) for a psychiatric evaluation. Record review of "Restraint/Seclusion Orders," dated 04/24/2011 at 0511, revealed the following types of restraints were ordered by the physician: "Side Rails intended to restrict bed exit...Chemical...RUE (Right Upper Extremity) (rigid), LUE (Left Upper Extremity) (rigid), LLE (Left Lower Extremity) (rigid), RLE (Right Lower Extremity) (rigid)..." Record review revealed the check box for Therapeutic Hold (physical restraint) was not checked. Record review of Nurse # 5's notes dated 04/24/2011 at 0650 revealed "Late entry (not timed) PT became extreamly (extremely) agitated unable to verbally deescalate....With assistance of Security Guard # 3 and CPO (Company Police Officer) # 2 PT was placed in a threaputic (therapeutic) hold and assited (assisted) to the floor. As to prevent harm to self." Record review revealed no physician order for a therapeutic hold.

Interview on 10/19/2011 at 1215 with the Service Line Director of Emergency Services revealed a physical hold was a restraint and therefore required a physician's order. Interview revealed if the restraint is a physical hold that does not progress to mechanical restraint "I do not believe a physician's order is always obtained, because it is a rapid situation that deescalated". Interview revealed, "It is required to get an order and the physician should evaluate the patient within 1 hour." Further interview with the Director at 1400 confirmed there was no available documentation of a physician's order for the physical restraint of the patient on 04/24/2011.

3. Closed medical record review for patient #7 revealed a 42 year old male presenting to the hospital's Emergency Department (ED) via private transportation on 06/29/2011 at 2011 with complaints of neck and back pain. Record review revealed the patient was discharged on 06/30/2011 at 1451 with diagnoses UTI (Urinary Tract Infection) and alcohol intoxication. Record review of Nurse #7 notes dated 06/30/2011 at 0848 revealed "...Pt (patient #7) found to have attempted to leave the ED. Pt escorted back to room 31...Pt stated he wanted to leave and smoke. Pt began swinging and acting out in the lobby. pt had to be taken to the floor by room 31 by security and panic alarm sounded by staff. Pt then proceeded to head butt the glass door of room 31..." Record review of physician #4 note dated 06/30/2011 at 0851 revealed "Pt got up, angry, verbally abusive and started to walk out of ED. I explained he could not leave due to ETOH (Alcohol) level. I told him not to leave or I would have to involuntarily commit him until legally sober. Pt came back in with staff escort, then tried to leave again and became combative. Pt now will be involuntarily committed until MBA (Alcohol Level) comes down." Record review revealed no physician order for the physical restraint (therapeutic hold) placed on the patient. Record review revealed no physician order for the physical restraint (therapeutic hold) placed on the patient.

Interview on 10/19/2011 at 1345 with physician #4 revealed the physician did not write an order for restraint or therapeutic hold of patient #7. Interview revealed physician #4 felt initiating the involuntary commitment paper was sufficient. Interview confirmed an order for the use of a therapeutic hold, physical restraint, was not written.

Interview on 10/19/2011 at 1215 with the Service Line Director of Emergency Services revealed a physical hold was a restraint and therefore required a physician's order. Interview revealed if the restraint is a physical hold that does not progress to mechanical restraint "I do not believe a physician's order is always obtained, because it is a rapid situation that deescalated". Interview revealed, "It is required to get an order and the physician should evaluate the patient within 1 hour." Further interview with the Director at 1400 confirmed there was no available documentation of a physician's order for the physical restraint of the patient on 06/30/2011.

Based on policy review, medical record review, video taped footage review, staff interview, and hospital investigation document review, the hospital failed to ensure restrained patients were monitored by trained staff for 3 of 11 sampled patients that were restrained by staff (Patients #5, #7, and #2).

The findings include:

Review of hospital policy entitled "Restraints, Seclusion, and Safety Devices" dated 06/28/2010 revealed, "POLICY:...The type or technique of restraint or seclusion is the least restrictive intervention that is effective to protect the patient, a staff member or others from harm....DEFINITIONS: 1. RESTRAINT - A manual method, physical or mechanical device, material or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely....7. INITIATION & ASSESSMENT: A qualified licensed staff member with established competencies may initiate seclusion or apply restraint. Assessment of the patient who has new onset or worsening of confusion/agitation is done by an RN (registered nurse) prior to or within 30 minutes of application of a restraint....11. RESTRAINT/SECLUSION MONITORING:...Behavioral Seclusion/Restraint: Staff provides continuous face-to-face observation of the patient in rigid limb restraint(s) and maintains documentation on the Restraint Flowsheet (excluding therapeutic holds less than 15 minutes) and on the Special Observation Flowsheet....At the initiation of seclusion or restraint, and every 15 minutes, a staff member monitors the patient with the intent to prevent harm and maintain well-being....15. DOCUMENTATION:...Each episode of restraint/seclusion use is recorded in the medical record. Documentation includes: a. The circumstances that led to their use; b. Consideration or failure of non-physical less restrictive interventions; c. Medical conditions or physical disability that would place the patient at greater risk....d. The rationale for the type of physical intervention selected; e. The type of restraint used,...vital signs, circulation to extremities,...patient response to treatment, patient rights, dignity and privacy maintained, and time released....h. Behavior criteria for release...; i. Informing the patient of behavior criteria for release from restraint...; l. Injuries that are sustained and treatment received for these injuries; and m. Deaths...."

1. Closed record review for Patient #5 revealed a 27 year-old male with a history of schizophrenia presented to the Emergency Department (ED) via Emergency Medical Services (EMS) on 04/17/2011 at 1638 with complaints of not taking his medicine. Record review revealed upon arrival the patient was placed in Room 65 (within the locked psychiatric area of the ED). Record review revealed the psychiatrist evaluated the patient and he was then involuntarily committed (IVC). Review of RN #1's note at 1929 revealed, "Assumed patient care. Patient awake and alert, breathing even and unlabored. Patient stares at RN, nonverbal. No response to questions or requests. Patient is INVOL(untary)." Review of RN #1's note at 1951 revealed, "Patient more verbal at this time, answering questions. Patient requested water; provided. patient continues to refuse to change into gown." Review of RN #1's note at 2017 revealed, "Patient continued to refuse gown, now stating ' I want my momma. I'm not putting on no mother (expletive) gown'. Patient more active in room, pacing. Patient multiple trips back and forth to bathroom; not following directions of security or nurse. CPO (Company Police Officer) and security to bedside; patient medicated." Review of RN #1's note at 2110 revealed, "Patient pacing in hallway, appears to becoming more agitated. Refusing to stay in room, becoming aggressive with staff. (RN #2) from Psych ED aware of patients increasing agitation; will inform (Physician #2)." Review of RN #1's note at 2120 revealed, "Patient now states he is leaving, attempting to walk to double doors. When patient informed that he must stay in room he became very angry. States 'I need some water'. Patient then picks up water and proceeds to pour water on all staff member. Patient instructed to stop by CPO and water taken from patient. Patient then attempts to leave room and begins to push and punch staff. Patient instructed to stop, refused. At this time patient was restrained by CPO and security. This RN then left area to inform Psychiatrist of situation. Upon returning to Psych area security states that patient has stopped resisting. When patient was moved to stretcher he was noted to have agonal respirations. Patient moved to resus(citation) room at this time." Review of RN #1's note at 2125 revealed, "Patient was being bagged with BVM (bag-valve mask). Upon arrival to resus room patient was pulseless, asystole on monitor; CPR (cardiopulmonary resuscitation) started." Review of RN #1's note at 2217 revealed, "Resuscitation attempts unsuccessful; efforts stopped. TOD (time of death) 2211." Record review revealed patient's body was sent to the Office of the Chief Medical Examiner for autopsy. Review of the "Report of Autopsy Examination" dated 09/06/2011 and signed by a physician from the Medical Examiner's office revealed, "Date of Exam 04/18/2011....SUMMARY AND INTERPRETATION....He was being involuntarily committed and was at the local hospital when his death occurred. He was agitated and attempting to leave his room when he was physically restrained by multiple individuals. Video of the events show one person placing an arm around his neck prior to him being taken to the ground. The neck restraint appears to be maintained as several other individuals restrain his body. His respiratory function would have been further compromised if overlay occurred on the chest and/or abdomen. The decedent appears unresponsive immediately following the restraint. Significant findings at autopsy include small, multifocal and thin subarachnoid hemorrhages, hemorrhages in the tongue and laryngeal mucosa and chronic active hepatitis of unknown etiology. Toxicology studies are positive for therapeutic concentrations of Risperidone (Risperdal) in aorta blood. Benzodiazepines, cocaine, ethanol, opiates, organic bases, ziprasidone and haloperidol are not detected. Based on the history and investigative findings, it is my opinion that the cause of death in this case is asphyxia due to restraint."

Review on 10/18/2011 at 1130 and on 10/20/2011 at 1130 of video taped footage of the Psychiatric Area of the ED dated 04/17/2011 and beginning at 2113 revealed two different views were recorded. Review on 10/18/2011 with a staff member from the ED (to identify staff in footage) and legal department staff revealed the camera angle from down the hall that showed Room 65 on the right side of the hall. Review on 10/20/2011 with the Vice President of Nursing and legal department staff revealed the camera angle was from down the hall and looking directly into Room 65. Review of the footage revealed the following events at the noted times:
? 21:13:00 - Patient #5 in room with lights off. CPO #1 and CPO #2 go into patient's room and turn lights on. One Security Officer (SO) in room and another SO at the patient's doorway looking into room (SO #1 and SO #2). RN #1 and RN #2 outside of and looking into room. (No nurse in room).
? 21:13:14 - RN #1 goes into room. SO #1 and SO #2 in room and CPO #1 and CPO #2 standing in doorway of room. Patient not in view.
? 21:13:26 - Patient walks into view in front of bed (which is against the back wall). All staff looking at patient. Patient sits on bed.
? 21:13:53 - Patient stands up off of bed with a cup in his hand.
? 21:14:16 - Patient throws water from cup onto a Security Officer (unable to determine which one). CPO reaches for cup.
? 21:14:22 - RN #1 goes out of room and out of view. RN #2 in doorway looking into room. Patient not in view, but can see 2 Security Officers and 1 CPO in room (other CPO is in room out of view). No nurse in room.
? 21:15:21 - Patient moves towards door and CPO #1 moves in front of him (between patient and door). SO #1 and SO #2 outside of and looking into room. RN #1 walks towards room while wiping her shirt with a towel.
? 21:15:22 - CPO #2 walks towards patient (from right side of room) with arms reached out towards patient.
? 21:15:23 - SO #1 and SO #2 move into the patient's doorway. Patient is facing doorway with CPO #1 on his right side and CPO #2 on his left side (both CPOs positioned towards the front of the patient).
? 21:15:25 - RN #1 turns away from the patient's room and walks down the hall. The 2 CPOs are holding the patient's arms, one on each side. (No nurse in room as physical restraint is initiated by CPOs).
? 21:15:26 - Patient lifts up slightly and sits on bed (CPOs still beside of and with hands on the patient).
? 21:15:28 - RN #1 looks over shoulder then turns around and faces the patient's room. SO #1 and SO #2 head into room. CPO #1 leans down towards bed. CPO #2 not in view.
? 21:15:29 - RN #1 turns back away from and continues to walk away from room. Patient is visible standing and facing towards the right side of the room. CPO #1 goes behind the patient. CPO #1 lifts his right arm out with elbow bent and moves it towards the patient.
? 21:15:30 - CPO #1's arm not visible. CPO #1 is leaning forward or bending down. Patient not visible. SO #1 and SO #2 in doorway looking in. CPO #1 and patient go backwards (towards left side of room) together. CPO #2 comes into view with in front of patient with his arms extended, but hands not visible. RN #1 looks back towards room again, then turns and continues to walk away from room.
? 21:15:31 - Patient's right hand is in the doorway, holding onto the door jam. The 2 Security Officers are still in the doorway. Both CPOs face the doorway as they and the patient are going down.
? 21:15:32 - Patient down and out of view. CPO #1 (who was behind patient) is not visible. CPO #2 in front of patient and leaning towards floor. SO #1 and SO #2 enter room and are on the right side of the patient, with their backs towards the camera. The Security Officer closest to the patient's legs is leaning down. (No nurse in room)
? 21:15:35 - CPO #2 leaning down towards patient and out of view. Both Security Officers leaning towards patient, the one near the top of the patient is standing and the one near the patient's legs is leaning towards patient with his (officers) legs extended to the side.
? 21:15:38 - CPO #1 and patient remain out of view. CPO #2 and both Security Officers are leaning towards the left, over the patient.
? 21:15:44 - The Two Security Officers stand, but still lean over the patient.
? 21:15:46 - One of the Security Officers goes around to the patient's other (left) side.
? 21:15:49 - CPO #1 and patient remain out of view. CPO #2 appears to be on the patient's legs.
? 21:15:52 - CPO #2 is up on his toes with his legs extended behind him. The top of his body is positioned towards the patient, but the view is blocked by the back of the Security Officer that is positioned on the patient's right side. (No nurse in room)
? 21:15:53 - Patient's right leg goes up, then down. Security Officer on right side of patient appears to hold it.
? 21:16:03 to 21:16:12 - The footage jumps and there is no footage available during this period of time.
? 21:16:12 - The Security Officer on the right side of the patient and CPO #2, now located near the patient's legs on the right side, are both leaning over the patient with their backs to the door. No one else in the room is visible.
? 21:16:27 - Security Officers and CPOs visible on floor, no apparent struggling at this point. (No nurse in room)
? 21:16:30 - RN #2 and RN #3 (a male psychiatric ED nurse) go to the doorway of the patient's room and look in.
? 21:16:35 - RN #2 goes into room (first time a nurse has been in room since CPOs put hands on patient at 21:15:25).
? 21:16:38 - RN #3 goes into room
? 21:16:42 - RN #3 leans toward patient's feet. CPO #1 now visible and near the top of and to the right of the patient. A Security Officer is visible on each side of the patient.
? 21:16:48 - RN #1 walks to door, drops restraints on the floor in the hall near the door, and turns and walks away from room. RN #2 goes into room and goes to the left side of the room.
? 21:16:54 - Both Security Officers now standing and leaning over patient. CPO #1 is near the top of the patient and is leaning over patient, either on his knees or with his legs extended.
? 21:16:55 - RN #2 leaning over the patient, near his head and to the left of CPO #1, then standing up.
? 21:17:04 - RN #2 comes out of room.
? 21:17:22 - Licensed Practical Nurse (LPN) #1 (an ED nurse) enters room, followed by 1 EMS staff and ED Tech #1. RN #1 is standing in the doorway with restraints in her hand.
? 21:17:48 - Security Officers and other staff are standing looking towards the patient on the floor.
? 21:17:50 - Several staff (unable to determine who or how many) lift the patient from the floor to the bed.
? 21:17:52 - Patient is on bed. Staff, including SO #1, SO #2, and CPO #2, surround the patient. CPO #1 is standing in the doorway.
? 21:17:54 - RN #1 goes into room with restraints in hand.
? 21:17:58 - CPO #1 goes out of room and rubs his head.
? 21:18:30 - Physician #2 (psychiatrist) walks towards room and stops and talks to CPO #1 in the hall on the way.
? 21:18:37 - Physician #2 stands in patient's doorway, leans on doorway, and looks into room. (Does not go into room).
? 21:18:42 - RN #4 (psychiatric nurse) walks towards room and talks to CPO #1 in hall.
? 21:18:49 - RN #3 is standing in room and looking down.
? 21:18:55 - Physician #2 walks away from room. RN #3 mops floor with towel.
? 21:19:02 - Patient is seen laying on bed. Patient is not moving and his clothes are off (can see naked right side).
? 21:19:08 - RN #2 exits room and talks to Physician #2 in hall.
? 21:19:34 - RN #3 exits room and talks to Physician #2 in hall. RN #2 goes back into room.
? 21:19:49 - RN #3 and CPO #1 go into room.
? 21:19:56 - RN #3 exits room. RN #1, RN #2, and LPN #1 are in room near the patient's head. Patient is not moving.
? 21:20:15 - RN #3 goes into room with BP (blood pressure) machine.
? 21:23:26 - Someone takes BP cuff off of patient's arm.
? 21:23:33 - Staff roll patient out of room on bed. He is naked with a sheet laying over his groin. Restraints are visible on his ankles (cannot see his clearly see his wrists). Patient is not moving.

Interview on 10/19/2011 at 1100 with Security Officer (SO) #1 revealed the officer was posted in the psychiatric area of the ED on 04/17/2011 from 4 PM to Midnight and was involved in the physical restraint of Patient #5. Interview revealed, "(When the patient was on the ground) I grabbed his legs and then moved to his arm, I think on the right side. I think the Company Police Officers (CPOs) were on his arms and upper body. As far as I could tell they were leaning on his chest....They had their back to us, so I don't remember if I could see his (the patient's) face or neck." Further interview revealed the officer thought he had to call, by waving his arm so as to be seen on video monitor at the ED desk, to get a nurse in the room. Interview revealed the officer thought someone had pushed the panic button (initiated an emergency response) because "so many" staff showed up. Further interview revealed, "We moved him to the bed. He was still struggling and urinating on himself (when on the floor and the bed). He was moving his arms and legs, trying to get up. He was muttering some stuff....They gave him some shots and tried to put restraints on because he was fighting pretty hard. Before putting restraints on him, they tried to get his clothes off and put a gown on him. I think they got a gown on him, but I'm not sure. Restraints were placed on his arms and legs by medical staff, I'm not sure who...a couple of females and a male. Sometime during that point he quit moving a lot, because they had given him the shots, it usually works pretty quick. That's when the nurse noticed there seems to be something wrong, seems like he's not breathing. She told (RN #2) to go get the bag (BVM). A male nurse checked the pulse and said it was weak. They got him out of there and to the resuscitation room."

Interview was requested with RN #1. Administrative staff informed surveyor RN #1 had moved and was no longer employed at the hospital. Review of hospital investigation documents revealed documentation of a "Witness Statement" for RN #1 dated 04/17/2011. Review of the statement revealed the following: The patient was IVC and began making attempts to leave the facility. He began pacing, cursing, and became physically violent with staff. CPO and security staff were at bedside and intervened when the patient made attempt to leave department and began assaulting staff. While CPO and security were attempting to calm patient, he threw water on staff members and the floor. He then lunged at the CPO and had to be restrained. RN #1 left the area at that time to inform the psychiatrist of the patient's status and events. Upon returning to the area, the patient had stopped resisting CPO and security and was placed on the stretcher. Patient then began to have ineffective breathing and was taken to the resuscitation room.

Interview on 10/18/2011 at 1515 with RN #2 revealed, "The patient made a move towards (CPO #2) so they called the other CPO (#1). I went to his room and he threw water towards staff....I'm not sure if his nurse was in the room. He backed up and said he was sorry and sat on his bed. I went to tell (Physician#2), but he was with another patient. I came back after I told (RN #3) what had happened. I went to the room and he was on the floor on his back...with a CPO towards the upper part of his body on his right side. Somebody had his feet....I don't know who, it was more than one person....He was struggling....I tried to tell him to calm down. I told him we'd let him up if he'd calm down and stop struggling. He was breathing and sweaty, but he was sweaty when he got there. I stepped out and was at the doorway and he stopped struggling. They were in the process of getting him up on the bed. He was a heavy boy....He was making raspy sounds on the bed....They determined he wasn't breathing. The ED nurse told me to go get the bag/mask....When I got back with the bag/mask they called a code and rushed him to the resuscitation room." Further interview revealed the psychiatric nurse works in the ED and also on the behavioral health unit. Interview revealed during a hold a patient should be monitored for breathing and safety. Interview revealed, "If we do a hold on behavioral health (unit) we document on the restraint form. They document differently in the ED."

Interview on 10/19/2011 at 0915 with RN #3 revealed the male nurse was a psychiatric nurse that worked in the ED. Interview revealed when the nurse arrived to the patient's room on 04/17/2011 the patient was on the floor with at least 4 security officers (including security officers and CPOs). Interview revealed, "(CPO #1) was up at the head on the patient's right side helping hold him down. He was holding his chest or head....was in a position to hold the top part of the body. Another person (unsure who) was on the patient's right side holding his right leg. (CPO #2) was on the left side holding his leg or thigh. A security officer...was semi-squatting over (CPO #2)....I held his left foot. A police or security officer was at the top of the left shoulder area. I couldn't see what he was holding. I was just seeing (other staffs') backsides....I think his primary nurse was in the room...but that might have been when I went back and we got him on the stretcher." Interview revealed the nurse wasn't sure what staff monitored the patient's condition during the physical restraint. Interview revealed, "I couldn't see him at all really. He was kicking and fussing and trying to be violent and all of that. I couldn't see his face....All I am seeing is back and arms. They would basically have to be holding him on the chest. He was a big fellow and was doing some pretty good struggling to start with...I could only see him from the knees down because they pretty much had him covered up with their bodies....I stopped holding his foot when he stopped fighting and I went out of the room to get the vital signs machine....I came back in with the vital signs machine and they (staff) were standing up and he didn't look like he was breathing. He had quit fighting. I think (LPN #1) said, 'Let's get him to the stretcher.'...After he was on the stretcher his breathing was very, very shallow....I don't remember his clothes coming off....One (restraint) got put on his leg....There's no point in doing that because he's not breathing right....Everybody's trying to look ahead and get him tied down in case that's what's needed. I got out of the way and they rolled him to the resuscitation room."

Interview on 10/20/2011 at 1245 with ED Technician #1 revealed during April 2011 the staff member worked as an ED Tech(nician), but starting in May 2011 he joined EMS as an Emergency Medical Technician (EMT). Interview revealed on 04/17/2011 the ED Tech went to the patient's room after he heard a radio call for security assistance. Interview revealed, "I went to see what was going on...The patient was standing and there were 2 Company Police Officers telling him to calm down. The patient was cursing and was trying to get out of his room. I left...and later went back over to see if the situation had calmed down. He (the patient) was on the floor. He was kicking and combative. I went to the right, to his feet....I couldn't see his face. They were around him so I couldn't see him....I never heard him say get off me or you're hurting me. He didn't say anything....The only parts (of him) I saw was the legs. I think 3 officers were at the top, I couldn't tell what position or what they were trying to hold....After he calmed down, he was still breathing. I helped lift him to the bed. He was calm and peaceful on the bed. They brought the vital signs machine in and took his vital signs. Then he started going down. Respirations didn't seem right...slow and thready respirations....I left to clear the hallway to move him and to get the resuscitation room ready....I don't remember taking his clothes off or putting restraints on him. He never struggled or fought when he was on the bed. (LPN #1) was at the head of the bed and was directing people....(RN #1) was in the doorway."

Interview was requested with LPN #1. Administrative staff informed surveyor LPN #1 had moved and was no longer employed at the hospital. Review of hospital investigation documents revealed documentation of an interview on 05/18/2011 of LPN #1 by Root Cause Analysis team members. Review of the interview revealed the interviewer documented the nurse's response as, "(RN #1) asked for help with restraints. When I got to the patient's room, he was still on the floor being restrained, but no longer resisting. We got him up on the stretcher, we were getting him straight and trying to get the restraints on and I didn't like his breathing. So, I repositioned his head, still didn't like his breathing. So I asked for a nasal airway. That didn't help, his respirations were decreased, agonal-like. The psych nurse brought the ambu (BVM) bag, but I was concerned about his poor respirations and I said 'We need to go' and we took him to the resuscitation room." Review revealed, when asked was there anything that caused the nurse concern about the case, the interviewer documented the nurse's response as, "I thought they were a little forceful while restraining him and I didn't like them holding him near his head and neck."

Interview on 10/19/2011 at 1215 with the Service Line Director of Emergency Services revealed physical restraints in the ED are usually rapid and temporary, not lasting more than a few minutes, until a patient either calms down or is placed in mechanical restraints. Interview revealed, "The nurse is with the patient the entire time that is happening. A tech can assist, at time security can assist, but we try not to use them. They follow the direction of nursing staff. The nurse should be clinically directing and overseeing that (the physical restraint). (The physically restrained patient) is monitored more often. A behavioral health emergency is the same as a medical emergency.

Interview on 10/20/2011 at 1130 with the Vice President of Nursing during video taped footage review of the physical restraint of Patient #5 on 04/17/2011 confirmed nursing staff was not continuously present and did not continuously supervise the restraint. Further interview confirmed nursing staff did not continuously monitor the patient to ensure safety during the physical restraint.


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2. Closed medical record review for patient #7 revealed a 42 year old male presenting to the hospital's Emergency Department (ED) via private transportation on 06/29/2011 at 2011 with complaints of neck and back pain. Record review revealed the patient was discharged on 06/30/2011 at 1451 with diagnoses UTI (Urinary Tract Infection) and alcohol intoxication. Record review of Nurse #7's notes dated 06/30/2011 at 0848 revealed "...Pt (patient #7) found to have attempted to leave the ED. Pt escorted back to room 31...Pt stated he wanted to leave and smoke. Pt began swinging and acting out in the lobby. pt had to be taken to the floor by room 31 by security and panic alarm sounded by staff. Pt then proceeded to head butt the glass door of room 31..." Record review of physician #4 note dated 06/30/2011 at 0851 revealed "Pt got up, angry, verbally abusive and started to walk out of ED. I explained he could not leave due to ETOH (Alcohol) level. I told him not to leave or I would have to involuntarily commit him until legally sober. Pt came back in with staff escort, then tried to leave again and became combative. Pt now will be involuntarily committed until MBA (Alcohol Level) comes down."

Review of hospital's Security Company's document titled "INCIDENT/INVESTIGATION REPORT" prepared by CPO (Company Police Officer) #4 and dated 06/30/2011 revealed "On Thursday June 30, 2011 at approximately 0830 hours I responded to blue zone room #31 in reference to an involuntarily committed white male (patient #7)...attempting to leave by fighting with Security Personnel and Medical staff....(Patient #7) became verbally uncooperative but got up off the floor and went into his room and sat down on his bed. (Security Officer #5) and I were standing outside the room obtaining information...when (Patient #7) jumped off his bed throwing his body and arms into the glass door of his room and sat back down on the bed. Approximately three or four minutes later (Patient #7) came out of his room and said 'arrest me I want you to (expletive) arrest me.' I informed (Patient #7) he was not under arrest but could not leave due to being involuntarily committed and attempted to walk him back to his room. I asked (Patient #7) to sit down and relax on his bed. (Patient #7) out his finger in my face and stated '(expletive) you get out of my face and my (expletive) room'. Once again I told (Patient #7) to relax. (Patient #7) pushed my chest and said '(expletive) you make me lay the (expletive) down and pushed me again. I attempted to gain control of (Patient #7)'s hands to keep from being pushed again when he became combative and resistant to my commands. Security Officer #5 entered the room along with Nurse #8 to assist me in gaining control of (Patient #7). (Patient #7) started thrashing and attempted to grab my handcuffs to prevent being handcuffed to the bed putting nicks and cuts on my fingers. Approximately ten to twelve minutes later I told (Patient #7) I would take him out of handcuffs if he agreed to cooperate with medical staff. (Patient #7) agreed. I took (Patient #7) out of handcuffs without further incident."

Interview on 10/21/2011 at 1200 with nurse #8 revealed, "The patient was trying to leave, (Physician #4) said 'you can't leave I'm going to IVC you'...we did have to do a therapeutic hold...I think I was at the waist, he was taken to the floor and he started to fight...there were 3 or 4 people, maybe, I don't remember...he was down about 20 seconds...I'm not 100% sure if the CPO put hand cuffs on him...we helped him to stand and walked him back to his room...(Physician #4) was there and saw the patient before and after (the hold)..I don't remember (patient #7) head butting the glass..." Interview revealed "...Hand cuffs are restraints when used by duly swore officers, but it is the ultimate responsibility of the nurse to monitor the patient...there are ways to walk a patient back without cuffs...I don't remember him being cuffed to the bed...there was a nurse in the room when I left..."

Further medical record review for Patient #7 revealed no documentation of how long the patient was on the floor, the patient's condition while on the floor, how the patient was held on the floor, what security staff where involved in the hold, or of the use of handcuffs by CPO staff to restrain the patient. Record review revealed patient #7's vital signs were not reassessed until 0952 on 06/30/2011 (1 hour and 4 mins after held to floor and subsequently handcuffed to the bed). Record review revealed no documentation of an assessment of the patient's wrists.

Interview on 10/21/2011 at 1445 with administrative nursing staff confirmed nursing did not reassess the patient's vital signs per policy after a physical restraint/hold or after the patient was handcuffed.

3. Closed medical record review for patient #2 revealed a 42 year old male presenting to the hospital's Emergency Department (ED) via Emergency Medical Services on 04/24/2011 at 0203 involuntarily committed (IVC) for a psychiatric evaluation. Record review of Nurse # 5's notes dated 04/24/2011 at 0456 revealed "...PT continues to be very agitated and begin(n)ing to self inflict. slapping slef (self) over body and arms...No orders given..." Record review revealed ED physician #3 ordered "Restraints-Mechanical...Leather 4 point" on 04/24/2011 at 0501 and "Ziprasidone (medication for short term control of severe agitation) 10 mg Inj (injection)" and "Lorazepam (medication used to calm and treat anxiety) 2 mg IM (intramuscular injection) " on 04/24/2011 at 0502. Record review of " Restraint/Seclusion Orders, " dated 04/24/2011 at 0511, revealed the following types of restraints were ordered by the physician: "Side Rails intended to restrict bed exit...Chemical...RUE (Right Upper Extremity) (rigid), LUE (Left Upper Extremity) (rigid), LLE (Left Lower Extremity) (rigid), RLE (Right Lower Extremity) (rigid)..." Record review of Unit Secretary's note dated 04/24/2011 at 0524 revealed the patient was moved to bed "Blue 26 South" (outside locked Psych Unit). Record review revealed Ziprasidone and Lorazepam, chemical restraints, were administered at 0528 and 0529, respectively, by nurse #6. Record review revealed the 4 point (bilateral wrists and ankles) leather (rigid) restraints were initiated at 0529. Record review of Unit Secretary's note dated 04/24/2011 at 0539 revealed Patient #2 was moved to "RED 63 South" (outside locked Psych Unit). Record review of Nurse #6's notes dated 04/24/2011 at 0551 revealed "Pt moved to room 63 from 29 on stretcher, in 4 point restraints. Pt on cardiac monitor, nibp (blood pressure) cuff and spo2 (Oxygen) monitor. Pt still rocking back in forth in bed from side to side and shaking his legs. Pt sinus tach (tachycardia -elevated heart rate) in 140's - 150's on monitor. (Physician #3) aware." Record review of Nurse # 5's notes dated 04/24/2011 at 0650 revealed "Late entry (not timed) PT became extreamly (extremely) agitated unable to verbally deescalate. PT pacing and shouting in room. Unable to obtain additional orders. Pt charged from room and begain (began) thoughing (throwing) his body against the doors tot he (of the) unit. With assistance of Security Guard # 3 and CPO (Company Police Officer) # 2 PT was placed in a threaputic (therapeutic) hold and assited (assisted) to the floor. As to prevent harm to self." Record review revealed Security Guard #3 and CPO #2 assisted Nurse #5 in the therapeutic hold of patient #2.

Based on policy review, medical record review, video taped footage review, staff interview, and hospital investigation document review, the hospital failed to ensure staff attempted the use of least restrictive interventions prior to restraint for 3 of 11 sampled patients that were restrained by staff (Patients #5, #7, and #2).

The findings include:

Review of hospital policy entitled "Restraints, Seclusion, and Safety Devices" dated 06/28/2010 revealed, "POLICY:...The type or technique of restraint...is the least restrictive intervention that is effective to protect the patient, a staff member or others from harm....DEFINITIONS: 1. RESTRAINT - A manual method, physical or mechanical device, material or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely....5. THERAPEUTIC HOLD - The brief physical holding of a patient in a manner that restricts his/her movement for the purpose of calming or providing physical safety to the patient , other patients, staff members or others. A therapeutic hold is used only by individuals trained in therapeutic hold techniques, and only when less restrictive measures have been attempted and have been determined to be ineffective. 6. FORENSIC RESTRAINTS - A locking restraint required by legal authorities when a person needs to be restrained to provide for safety or detention by legal authorities for legal reasons when that person is in custody of legal authorities or is under arrest/police hold in accordance with Federal and State laws and regulations....Forensic restraint mechanisms (...handcuffs,...)are not health care restraint interventions and are not applied by the staff of (Name of Hospital)....PROCEDURES:....4. Less Restrictive Alternatives: Attempts are made to evaluate and/or consider interventions/alternatives such as:...b. Environmental Measures: i. Decrease stimulation; quiet surroundings....c. Comfort Measures:....iv. Gentle touch, soothing voice....f. Diversional Activities: i. Distract patient with videos, TV, photographs, radio, reading materials, engage in conversation....iii. Provide alternative activity for hands, i.e. rubber ball, squeezing devices, etc....h. Interpersonal Skills: i. Pleasant, consistent interaction with patient....ii. Actively listen to patient, calm reassurance....i. Communication/Interpersonal Relationships....iv. Respect a patient's need for personal space....6. CLINICAL JUSTIFICATION:...Behavioral Seclusion/Restraint:...Clinical justification includes: Harmful to self or others, as evidenced by hitting, hair pulling, striking at or biting staff or family, and/or self-mutilation or serious destruction to unit property, and appropriate alternative measures have been attempted....15. DOCUMENTATION: Documentation in the patient's record is to indicate a clear progression in how techniques were implemented with less intrusive restrictive intervention attempted or considered prior to the introduction of more restrictive measures....Each episode of restraint/seclusion use is recorded in the medical record. Documentation includes: a. The circumstances that led to their use; b. Consideration or failure of non-physical less restrictive interventions....d. The rationale for the type of physical intervention selected.... "

1. Closed record review for Patient #5 revealed a 27 year-old male with a history of schizophrenia presented to the Emergency Department (ED) via Emergency Medical Services (EMS) on 04/17/2011 at 1638. Review of EMS documentation prior to arrival to hospital revealed, "Patient presented to ems very anxious, paranoid actions and behavior. Family member advised that patient had stopped taking Risperdal (antipsychotic medication) when the packaging came in different form. Patient also been hearing voices with hallucination. Patient non violent at this present time but very quiet and with paranoid tendencies. Patient cooperated with ems to go to hospital." Record review revealed upon arrival the patient was placed in Room 65 (within the locked psychiatric area of the ED). Review of nurse's notes at 1707 revealed, "Patient calm cooperative, no respiratory distress, pt (patient) ambulatory to bathroom gait steady...." Record review revealed RN #2 completed a psychiatric nursing evaluation of the patient at 1720. Review of RN #2's psychiatric assessment revealed, "Pt not sure why he is here. Confused. Paranoid + restless. Pacing around room. Said he had an outburst at home. Slow to respond to questions. Denies SI/HI (suicidal/homicidal ideations) + hallucinations. Angry at his mother....appears to be responding to internal stimuli....Lives c (with) mother....Drinks occasionally. 0 (no - denies) drugs. Got upset. Had an outburst - taking medication...." Record review revealed at 1751 Physician #1 ordered a psychiatric evaluation and psychiatric precautions. Review of nurse's notes at 1758 revealed, "Psychiatric Precautions....pt . denies homicidal idealations, pt denies suicidal idealations...calm and cooperative, makes eye contact when communicating, alert and oriented X 3. Assessment: cooperative at this time...." Record review revealed Physician #2 (psychiatrist) evaluated the patient. Review of Physician #2's orders at 1842 revealed, "Medication Orders: Risperdal M-tab 2 mg (milligrams) Note: give 4 mg po (by mouth) now." Review of RN #2's notes at 1845 revealed, "(Physician #2) completed evaluation. Pt to be diverted to 1st accepting facility. IVC (involuntary commitment) papers initiated at 1845. Primary nurse and security made aware). Record review revealed documentation at 1850 the patient was administered Risperdal M-tab 4 mg by mouth. Review of RN #1's note at 1929 revealed, "Assumed patient care. Patient awake and alert, breathing even and unlabored. Patient stares at RN, nonverbal. No response to questions or requests. Patient is INVOL(untary)." Review of RN #1's note at 1951 revealed, "Patient more verbal at this time, answering questions. Patient requested water; provided. patient continues to refuse to change into gown." Review of RN #1's note at 2017 revealed, "Patient continued to refuse gown, now stating ' I want my momma. I'm not putting on no mother (expletive) gown'. Patient more active in room, pacing. Patient multiple trips back and forth to bathroom; not following directions of security or nurse. CPO (Company Police Officer) and security to bedside; patient medicated." Record review revealed documentation at 2018 the patient was administered Ativan (anti-anxiety medication) 2 mg and Geodon (antipsychotic medication) 20 mg via intramuscular injection (IM) per Physician #2's orders. Review of RN #1's note at 2053 revealed, "Patient refusing labs and urine at this time; continues to appear agitated and paces in room at times. Patient now more lucid asking where is and how he got here. Patient reoriented." Review of RN #1's note at 2110 revealed, "Patient pacing in hallway, appears to becoming more agitated. Refusing to stay in room, becoming aggressive with staff. (RN #2) from Psych ED aware of patients increasing agitation; will inform (Physician #2)." Review of RN #1's note at 2120 revealed, "Patient now states he is leaving, attempting to walk to double doors. When patient informed that he must stay in room he became very angry. States 'I need some water'. Patient then picks up water and proceeds to pour water on all staff member. Patient instructed to stop by CPO and water taken from patient. Patient then attempts to leave room and begins to push and punch staff. Patient instructed to stop, refused. At this time patient was restrained by CPO and security. This RN then left area to inform Psychiatrist of situation. Upon returning to Psych area security states that patient has stopped resisting. When patient was moved to stretcher he was noted to have agonal respirations. Patient moved to resus(citation) room at this time." Review of RN #1's note at 2125 revealed, "Patient was being bagged with BVM (bag-valve mask). Upon arrival to resus room patient was pulseless, asystole on monitor; CPR (cardiopulmonary resuscitation) started." Review of RN #1's note at 2217 revealed, "Resuscitation attempts unsuccessful; efforts stopped. TOD (time of death) 2211." Review of RN #1's note at 0141 revealed, "Addendum to documentation charted at 2120. --As security was transferring patient to stretcher rigid restraints were being placed on limbs. Limb devices were placed around ankles and wrists, but at not time were they secured to stretcher/bed. Patient was not restrained with the limb devices at any point." Record review revealed patient's body was sent to the Office of the Chief Medical Examiner for autopsy. Review of the "Report of Autopsy Examination" dated 09/06/2011 and signed by a physician from the Medical Examiner's office revealed, "Date of Exam 04/18/2011....SUMMARY AND INTERPRETATION....He was being involuntarily committed and was at the local hospital when his death occurred. He was agitated and attempting to leave his room when he was physically restrained by multiple individuals. Video of the events show one person placing an arm around his neck prior to him being taken to the ground. The neck restraint appears to be maintained as several other individuals restrain his body. His respiratory function would have been further compromised if overlay occurred on the chest and/or abdomen. The decedent appears unresponsive immediately following the restraint. Significant findings at autopsy include small, multifocal and thin subarachnoid hemorrhages, hemorrhages in the tongue and laryngeal mucosa and chronic active hepatitis of unknown etiology. Toxicology studies are positive for therapeutic concentrations of Risperidone (Risperdal) in aorta blood. Benzodiazepines, cocaine, ethanol, opiates, organic bases, ziprasidone and haloperidol are not detected. Based on the history and investigative findings, it is my opinion that the cause of death in this case is asphyxia due to restraint."

Review on 10/18/2011 at 1130 and on 10/20/2011 at 1130 of video taped footage of the Psychiatric Area of the ED dated 04/17/2011 and beginning at 2113 revealed two different views were recorded. Review on 10/18/2011 with a staff member from the ED (to identify staff in footage) and legal department staff revealed the cameral angle from down the hall that showed Room 65 on the right side of the hall. Review on 10/20/2011 with the Vice President of Nursing and legal department staff revealed the camera angle was from down the hall and looking directly into Room 65. Review of the footage revealed the following events at the noted times:
? 21:13:00 - Patient #5 in room with lights off. CPO #1 and CPO #2 go into patient's room and turn lights on. One Security Officer (SO) in room and another SO at the patient's doorway looking into room (SO #1 and SO #2). RN #1 and RN #2 outside of and looking into room.
? 21:13:14 - RN #1 goes into room. SO #1 and SO #2 in room and CPO #1 and CPO #2 standing in doorway of room. Patient not in view.
? 21:13:26 - Patient walks into view in front of bed (which is against the back wall). All staff looking at patient. Patient sits on bed.
? 21:13:53 - Patient stands up off of bed with a cup in his hand.
? 21:14:16 - Patient throws water from cup onto a Security Officer (unable to determine which one). CPO reaches for cup.
? 21:14:22 - RN #1 goes out of room and out of view. RN #2 in doorway looking into room. Patient not in view, but can see 2 Security Officers and 1 CPO in room (other CPO is in room out of view).
? 21:14:34 - Patient stands in view with CPO #1 in front of him. Patient then sits in a chair to left side of room. The 2 Security Officers are now outside of the room, one of them wipes off his glasses.
? 21:14:54 - RN #1 stands in doorway of room.
? 21:14:55 - Patient stands up. CPO #1 standing in front of patient and CPO #2 on the right side of room. RN #2 walks away from room and out of view.
? 21:15:15 - Security Officer in hall wipes his pants off with a towel and RN #1 steps away from patient's door and helps him. Patient visible standing in room with CPO #1 standing in front of him.
? 21:15:21 - Patient moves towards door and CPO #1 moves in front of him (between patient and door). SO #1 and SO #2 outside of and looking into room. RN #1 walks towards room while wiping her shirt with a towel.
? 21:15:22 - CPO #2 walks towards patient (from right side of room) with arms reached out towards patient.
? 21:15:23 - SO #1 and SO #2 move into the patient's doorway. Patient is facing doorway with CPO #1 on his right side and CPO #2 on his left side (both CPOs positioned towards the front of the patient).
? 21:15:25 - RN #1 turns away from the patient's room and walks down the hall. The 2 CPOs are holding the patient's arms, one on each side.
? 21:15:26 - Patient lifts up slightly and sits on bed (CPOs still beside of and with hands on the patient).
? 21:15:28 - RN #1 looks over shoulder then turns around and faces the patient's room. SO #1 and SO #2 head into room. CPO #1 leans down towards bed. CPO #2 not in view.
? 21:15:29 - RN #1 turns back away from and continues to walk away from room. Patient is visible standing and facing towards the right side of the room. CPO #1 goes behind the patient. CPO #1 lifts his right arm out with elbow bent and moves it towards the patient.
? 21:15:30 - CPO #1's arm not visible. CPO #1 is leaning forward or bending down. Patient not visible. SO #1 and SO #2 in doorway looking in. CPO #1 and patient go backwards (towards left side of room) together. CPO #2 comes into view with in front of patient with his arms extended, but hands not visible. RN #1 looks back towards room again, then turns and continues to walk away from room.
? 21:15:31 - Patient's right hand is in the doorway, holding onto the door jam. The 2 Security Officers are still in the doorway. Both CPOs face the doorway as they and the patient are going down.
? 21:15:32 - Patient down and out of view. CPO #1 (who was behind patient) is not visible. CPO #2 in front of patient and leaning towards floor. SO #1 and SO #2 enter room and are on the right side of the patient, with their backs towards the camera. The Security Officer closest to the patient's legs is leaning down.
? 21:15:35 - CPO #2 leaning down towards patient and out of view. Both Security Officers leaning towards patient, the one near the top of the patient is standing and the one near the patient's legs is leaning towards patient with his (officers) legs extended to the side.
? 21:15:38 - CPO #1 and patient remain out of view. CPO #2 and both Security Officers are leaning towards the left, over the patient.
? 21:15:44 - The Two Security Officers stand, but still lean over the patient.
? 21:15:46 - One of the Security Officers goes around to the patient's other (left) side.
? 21:15:49 - CPO #1 and patient remain out of view. CPO #2 appears to be on the patient's legs.
? 21:15:52 - CPO #2 is up on his toes with his legs extended behind him. The top of his body is positioned towards the patient, but the view is blocked by the back of the Security Officer that is positioned on the patient's right side.
? 21:15:53 - Patient's right leg goes up, then down. Security Officer on right side of patient appears to hold it.
? 21:16:03 to 21:16:12 - The footage jumps and there is no footage available during this period of time.
? 21:16:12 - The Security Officer on the right side of the patient and CPO #2, now located near the patient's legs on the right side, are both leaning over the patient with their backs to the door. No one else in the room is visible.
? 21:16:27 - Security Officers and CPOs visible on floor, no apparent struggling at this point.
? 21:16:30 - RN #2 and RN #3 (a male psychiatric ED nurse) go to the doorway of the patient's room and look in.
? 21:16:35 - RN #2 goes into room
? 21:16:38 - RN #3 goes into room
? 21:16:42 - RN #3 leans toward patient's feet. CPO #1 now visible and near the top of and to the right of the patient. A Security Officer is visible on each side of the patient.
? 21:16:48 - RN #1 walks to door, drops restraints on the floor in the hall near the door, and turns and walks away from room. RN #2 goes into room and goes to the left side of the room.
? 21:16:54 - Both Security Officers now standing and leaning over patient. CPO #1 is near the top of the patient and is leaning over patient, either on his knees or with his legs extended.
? 21:16:55 - RN #2 leaning over the patient, near his head and to the left of CPO #1, then standing up.
? 21:16:59 - 2 EMS staff and ED Tech(nician) #1 arrive and enter into room.
? 21:17:02 - 1 of the EMS staff goes towards the patient's head and looks down.
? 21:17:04 - RN #2 comes out of room.
? 21:17:10 - 2 EMS staff and ED Tech #1 come out of room.
? 21:17:22 - Licensed Practical Nurse (LPN) #1 (an ED nurse) enters room, followed by 1 EMS staff and ED Tech #1. RN #1 is standing in the doorway with restraints in her hand.
? 21:17:35 - Second EMS staff goes into room.
? 21:17:41 - A staff member inside room (unable to determine which one) is seen putting a sheet on the bed.
? 21:17:48 - Security Officers and other staff are standing looking towards the patient on the floor.
? 21:17:50 - Several staff (unable to determine who or how many) lift the patient from the floor to the bed.
? 21:17:52 - Patient is on bed. Staff, including SO #1, SO #2, and CPO #2, surround the patient. CPO #1 is standing in the doorway.
? 21:17:54 - RN #1 goes into room with restraints in hand.
? 21:17:58 - CPO #1 goes out of room and rubs his head.
? 21:18:30 - Physician #2 (psychiatrist) walks towards room and stops and talks to CPO #1 in the hall on the way.
? 21:18:37 - Physician #2 stands in patient's doorway, leans on doorway, and looks into room. (Does not go into room).
? 21:18:42 - RN #4 (psychiatric nurse) walks towards room and talks to CPO #1 in hall.
? 21:18:49 - RN #3 is standing in room and looking down.
? 21:18:55 - Physician #2 walks away from room. 1 EMS staff exits room. RN #3 mops floor with towel.
? 21:19:02 - Patient is seen laying on bed. Patient is not moving and his clothes are off (can see naked right side).
? 21:19:08 - RN #2 exits room and talks to Physician #2 in hall.
? 21:19:34 - RN #3 exits room and talks to Physician #2 in hall. Other EMS staff exits room. RN #2 goes back into room.
? 21:19:49 - RN #3 and CPO #1 go into room.
? 21:19:56 - RN #3 exits room. RN #1, RN #2, and LPN #1 are in room near the patient's head. Patient is not moving.
? 21:20:15 - RN #3 goes into room with BP (blood pressure) machine.
? 21:20:36 - Security Supervisor goes to and looks into room.
? 21:23:26 - Someone takes BP cuff off of patient's arm.
? 21:23:33 - Staff roll patient out of room on bed. He is naked with a sheet laying over his groin. Restraints are visible on his ankles (cannot see his clearly see his wrists). Patient is not moving.

Interview on 10/19/2011 at 1100 with Security Officer (SO) #1 revealed the officer was posted in the psychiatric area of the ED on 04/17/2011 from 4 PM to Midnight. Interview revealed when Patient #5 arrived to Room 65 "staff decided he didn't need to change (into gown) right away. That was their call....I wanded him.". Interview revealed SO #2 walked through the psychiatric area of the ED to see if SO #1 needed any assistance. Further interview revealed, "He (The patient) was calm at first. The longer he sat he got more agitated. (SO #2) decided to stay with me due to his agitation. We don't usually let patients walk in the halls (in the psychiatric area of the ED), but in this occasion I let him walk in the hall. It seemed to calm him. He went back and forth to the bathroom and his room. We kept our distance and kept an eye on him. He didn't say a lot. He had this white stuff around the outside of his mouth. We told the nurse about it because we have seen patients that have been doing spice or something (illicit substances) like that. Its just an observation we had noticed in the past. He was muttering stuff like he wanted to go home." Interview revealed the patient became more agitated and began hitting the bed and wall. Interview revealed SO #1 called Company Police for assistance once before the end of the 0700-1900 shift and CPO #2 came to psychiatric area. Interview revealed, "They came and hung around for a little bit and then left." Interview revealed, "I think he was given a pill before (dayshift nurse) left at 7 PM. It seemed like it made him worse. He really started to hit the walls and bed. (He had) muttered talking, not making any sense. He would come out (of his room) a little bit and we'd ask him to go back and he would eventually go back. (RN #1) came on and I told her about his behavior. I don't remember if she went in to see the patient. I called Company Police again and (CPO #2) came and saw the patients behavior and called (CPO #1) to come." Interview revealed at this point the patient's behavior had escalated and "it looked like he was about to act out severely". Interview revealed, "I think the nurse came and tried to speak to him. He didn't calm down. The two Company Policy Officers came into his room and told me and (SO #2) to step back. They took charge." Interview revealed at that point the two security officers went out of the patient's room and stood in the doorway. Interview revealed, "They (The CPOs) told the patient medical staff needed to take care of him, take blood or whatever. He (The patient) went at (CPO #1), swung and knocked (CPO #1) against the wall. (CPO #1) and (CPO #2) got him to the ground....I didn't see anyone grab his neck or shoulders, basically just his legs....(When the patient was on the ground) I grabbed his legs and then moved to his arm, I think on the right side. I think the Company Police Officers were on his arms and upper body. As far as I could tell they were leaning on his chest....They had their back to us, so I don't remember if I could see his (the patient's) face or neck." Further interview revealed, "We moved him to the bed. He was still struggling and urinating on himself (when on the floor and the bed). He was moving his arms and legs, trying to get up. He was muttering some stuff....They gave him some shots and tried to put restraints on because he was fighting pretty hard. Before putting restraints on him, they tried to get his clothes off and put a gown on him. I think they got a gown on him, but I'm not sure. Restraints were placed on his arms and legs by medical staff, I'm not sure who...a couple of females and a male. Sometime during that point he quit moving a lot, because they had given him the shots, it usually works pretty quick. That's when the nurse noticed there seems to be something wrong, seems like he's not breathing. She told (RN #2) to go get the bag (BVM). A male nurse checked the pulse and said it was weak. They got him out of there and to the resuscitation room."

Interview was requested with and declined by CPO #1. Review of hospital investigation documents revealed documentation of an interview on 05/19/2011 of CPO #1 by Root Cause Analysis team members. Review of the interview revealed CPO #1 first responded on 04/17/2011 at 2000 and talked with the patient, who appeared to be afraid, and held the patient for a shot. Review of the interview revealed at 2100 CPO #1 was called back to the psychiatric area, at which time the patient was walking out of his room. Review of the interview revealed the patient was completely different and was more agitated and asking for water. Review revealed the patient threw water and CPO #1 grabbed hold of him. Review revealed the patient grabbed the CPO's badge, and the CPO grabbed his wrist to get him to release it. Review revealed the patient grabbed the badge again and tried to push the CPO out of the room. Review revealed, "Officer (CPO #1) slipped, pulled patient on top of him with shirt. Hit head on wall. (CPO #1) thinking about rolling fingers under jaw, can't remember if he did it or not." Review revealed Security Officers held the patient's arms and legs. Review revealed, "(CPO #1) got out from under him, laid on his (the patient's) shoulder." Review revealed, when CPO #1 was asked if anything about this case concerned him, he responded the patient had received only one injection, that had more medications than usual in the syringe, and nurses don't know how to apply leather restraints, officers used to apply leathers, now they don't. Review revealed, when CPO #1 was asked who has authority to place a patient in physical restraints, he responded officers not allowed, nurses don't know how. Review revealed, when CPO #1 was asked what he does when a patient starts to escalate and how he was trained in de-escalating patients, his response was documented by the interviewer as "Put arms across jaw to keep his head turned away. Patient blubbering, blowing foam and spit. Patient quit moving. Patient still breathing. Moved to stretcher. Put restraints on legs. Moved to arms and LPN noticed he wasn't breathing. Patient arched back and took one big breath. Training: soft hands - pain compliance; no marks left but cause pain; wrist lock; and nerve under jaw. hard hands - punches".

Interview was requested with and declined by CPO #2. Review of hospital investigation documents revealed documentation of an interview on 05/12/2011 of CPO #2 by Root Cause Analysis team members. Review of the interview revealed CPO #2 received a call from SO #1, saying they were trying to get the patient in a gown, at around 2000 on 04/17/2011. Review revealed CPO #2 responded and stayed with the patient, SO #1, and SO #2. Review revealed after about 1 hour the patient kept asking where he was where his mother was. Review revealed CPO #2 said his sixth sense told him to stay in the room with the patient. Review revealed CPO #2 said he thought several people need to stay. Review of interview revealed, "They kept telling patient to stay in room, but he kept going to the bathroom and as the hour progressed he got more and more agitated. They heard him strike the wall one time. The called (CPO #1) to ask him to come to patient's room. Patient sat on bed (not sure if voluntary or if they asked him to). Patient asked for some water, which (CPO #1) gave him and the patient 'sprinkled ' water on them. (CPO #1) told him to stop and he did. Then they had to tell him again. (CPO #1) was standing directly in front of patient. 2 security guards standing behind them in hallway. Patient put his hands on (CPO #1). States as a natural reaction to protect themselves (CPO #1) got behind him and had him by his mid-section. Both (CPO #1) and patient fell against wall and then to the floor. Then the 2 security guards joined in to help. (SO #2) had patients left arm. (SO #1) had (unable to read text). (CPO #2) in front of him. Brought patient under control through physical restraint...." Review revealed, when CPO #2 was asked what he does when a patient starts to escalate and how he was trained in de-escalating patients, his response was documented by the interviewer as "Training: No department training. As Police Officer get: hand cuff training, unarmed self-defense training (how to grab wrists and arms to gain control), painful force training, and training to de-escalate situation includes verbal, soft hands, equipment to include pepper spray and use of baton (depends on how it escalates)".

Interview was requested with RN #1. Administrative staff informed surveyor RN #1 had moved and was no longer employed at the hospital. Review of hospital investigation documents revealed documentation of a "Witness Statement" for RN #1 dated 04/17/2011. Review of the statement revealed the following: The patient was IVC and began making attempts to leave the facility. He began pacing, cursing, and became physically violent with staff. CPO and security staff were at bedside and intervened when the patient made attempt to leave department and began assaulting staff. While CPO and security were attempting to calm patient, he threw water on staff members and the floor. He then lunged at the CPO and had to be restrained. RN #1 left the area at that time to inform the psychiatrist of the patient's status and events. Upon returning to the area, the patient had stopped resisting CPO and security and was placed on the stretcher. Patient then began to have ineffective breathing and was taken to the resuscitation room.

Interview on 10/18/2011 at 1515 with RN #2 revealed, "The patient made a move towards (CPO #2) so they called the other CPO (#1). I went to his room and he threw water towards staff....I'm not sure if his nurse was in the room. He backed up and said he was sorry and sat on his bed. I went to tell (Physician#2), but he was with another patient. I came back after I told (RN #3) what had happened. I went to the room and he was on the floor on his back...with a CPO towards the upper part of his body on his right side. Somebody had his feet....I don't know who, it was more than one person....He was struggling....I tried to tell him to calm down. I told him we'd let him up if he'd calm down and stop struggling. He was breathing and sweaty, but he was sweaty when he got there. I stepped out and was at the doorway and he stopped struggling. They were in the process of getting him up on the bed. He was a heavy boy....He was making raspy sounds on the bed....They determined he wasn't breathing. The ED nurse told me to go get the bag/mask....When I got back with the bag/mask they called a code and rushed him to the resuscitation room."

Interview on 10/19/2011 at 0915 with RN #3 revealed the male nurse was a psychiatric nurse that worked in the ED. Interview revealed when the nurse arrived to the patient's room on 04/17/2011 the patient was on the floor with at least 4 security officers (including security officers and CPOs). Interview revealed, "(CPO #1) was up at the head on the patient's right side helping hold him down. He was holding his chest or head....was in a position to hold the top part of the body. Another person (unsure who) was on the patient's right side holding his right leg. (CPO #2) was on the left side holding his leg or thigh. A security officer...was semi-squatting over (CPO #2)....I held his left foot. A police or security officer was at the top of the left shoulder area. I couldn't see what he was holding. I was just seeing (other staffs') backsides....I think his primary nurse was in the room...but that might have been when I went back and we got him on the stretcher." Interview revealed, "I couldn't see his face....All I am seeing is back and arms. They would basically have to be holding him on the chest. He was a big fellow and was doing some pretty good struggling to start with...I could only see him from the knees down because they pretty much had him covered up with their bodies....I stopped holding his foot when he stopped fighting and I went out of the room to get the vital signs machine....I came back in with the vital signs machine and they (staff) were standing up and he didn't look like he was breathing. He had quit fighting. I think (LPN #1) said, 'Let's get him to the stretcher.'...After he was on the stretcher his breathing was very, very shallow....I don't remember his clothes coming off....One (restraint) got put on his leg....There's no point in doing that because he's not breathing right....Everybody's trying to look ahead and get him tied down in case that's what's needed. I got out of the way and they rolled him to the resuscitation room."

Interview was requested with LPN #1. Administrative staff informed surveyor LPN #1 had moved and was no longer employed at the hospital. Review of hospital investigation documents revealed documentation of an interview on 05/18/2011 of LPN #1 by Root Cause Analysis team members. Review of the interview revealed the interviewer documented the nurse's response as, "(RN #1) asked for help with restraints. When I got to the patient's room, he was still on the floor being restrained, but not longer resisting. We got him up on the stretcher, we were getting him straight and trying to get the restraints on and I didn't like his breathing. So, I repositioned his head, still didn't like his breathing. So I asked for a nasal airway. That didn't

Based on policy review, medical record review, video taped footage review, personnel file review, staff interview, and hospital investigation document review, the hospital failed to ensure safe implementation of restraint by trained staff for 3 of 11 sampled patients that were restrained by staff (Patients #5, #2, and #7).

The findings include:

Review of hospital policy entitled "Restraints, Seclusion, and Safety Devices" dated 06/28/2010 revealed, "POLICY:...The type or technique of restraint or seclusion is the least restrictive intervention that is effective to protect the patient, a staff member or others from harm. Restraints...are used in a manner that attempts to prevent harm, physical discomfort, embarrassment, or pain to the patient....DEFINITIONS: 1. RESTRAINT - A manual method, physical or mechanical device, material or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely....5. THERAPEUTIC HOLD - The brief physical holding of a patient in a manner that restricts his/her movement for the purpose of calming or providing physical safety to the patient, other patients, staff members or others. A therapeutic hold is used only by individuals trained in therapeutic hold techniques, and only when less restrictive measures have been attempted and have been determined to be ineffective. 6. FORENSIC RESTRAINTS - A locking restraint required by legal authorities when a person needs to be restrained to provide for safety or detention by legal authorities for legal reasons when that person is in custody of legal authorities or is under arrest/police hold in accordance with Federal and State laws and regulations....Forensic restraint mechanisms (...handcuffs,...)are not health care restraint interventions and are not applied by the staff of (Name of Hospital)....PROCEDURES:....2. TRAINING: Hospital staff involved in meeting the patient's needs are educated upon hire before they participate in the use of seclusion/restraint and annually thereafter. Training can be completed via didactic class or online self-study with successful completion of a post-test and competency. Hospital staff includes personnel from the following areas: Nursing,...Security,....Training Requirements Include: a. The underlying causes of threatening behavior. b. Less restrictive alternative. c. Proper and safe application/removal...of restraints. d. Monitoring patient's physical/psychological status....15. DOCUMENTATION:...Only hospital personnel, who have received training and demonstrated competency are to document information related to the use of restraints within the scope of their license...."

1. Closed record review for Patient #5 revealed a 27 year-old male with a history of schizophrenia presented to the Emergency Department (ED) via Emergency Medical Services (EMS) on 04/17/2011 at 1638 with a complaint of not taking his medication. Record review revealed the patient was involuntarily committed by the physician. Review of RN #1's note at 2120 revealed, "Patient now states he is leaving, attempting to walk to double doors. When patient informed that he must stay in room he became very angry. States 'I need some water'. Patient then picks up water and proceeds to pour water on all staff member. Patient instructed to stop by CPO and water taken from patient. Patient then attempts to leave room and begins to push and punch staff. Patient instructed to stop, refused. At this time patient was restrained by CPO and security. This RN then left area to inform Psychiatrist of situation. Upon returning to Psych area security states that patient has stopped resisting. When patient was moved to stretcher he was noted to have agonal respirations. Patient moved to resus(citation) room at this time." Review of RN #1's note at 2125 revealed, "Patient was being bagged with BVM (bag-valve mask). Upon arrival to resus room patient was pulseless, asystole on monitor; CPR (cardiopulmonary resuscitation) started." Review of RN #1's note at 2217 revealed, "Resuscitation attempts unsuccessful; efforts stopped. TOD (time of death) 2211." Record review revealed patient's body was sent to the Office of the Chief Medical Examiner for autopsy. Review of the "Report of Autopsy Examination" dated 09/06/2011 and signed by a physician from the Medical Examiner's office revealed, "Date of Exam 04/18/2011....SUMMARY AND INTERPRETATION....He was being involuntarily committed and was at the local hospital when his death occurred. He was agitated and attempting to leave his room when he was physically restrained by multiple individuals. Video of the events show one person placing an arm around his neck prior to him being taken to the ground. The neck restraint appears to be maintained as several other individuals restrain his body. His respiratory function would have been further compromised if overlay occurred on the chest and/or abdomen. The decedent appears unresponsive immediately following the restraint. Significant findings at autopsy include small, multifocal and thin subarachnoid hemorrhages, hemorrhages in the tongue and laryngeal mucosa and chronic active hepatitis of unknown etiology. Toxicology studies are positive for therapeutic concentrations of Risperidone (Risperdol) in aorta blood. Benzodiazepines, cocaine, ethanol, opiates, organic bases, ziprasidone and haloperidol are not detected. Based on the history and investigative findings, it is my opinion that the cause of death in this case is asphyxia due to restraint."

Review on 10/18/2011 at 1130 and on 10/20/2011 at 1130 of video taped footage of the Psychiatric Area of the ED dated 04/17/2011 and beginning at 2113 revealed two different views were recorded. Review on 10/18/2011 with a staff member from the ED (to identify staff in footage) and legal department staff revealed the cameral angle from down the hall that showed Room 65 on the right side of the hall. Review on 10/20/2011 with the Vice President of Nursing and legal department staff revealed the camera angle was from down the hall and looking directly into Room 65. Review of the footage revealed the patient was physically restrained from 21:15:26 (when CPOs begin to hold the patient by his arms and then go to the floor with the patient at 21:15:30) until 21:17:50 (when staff lift the patient off of the floor and place him on a stretcher). Video footage review revealed several staff were involved in the physical restraint of the patient, including CPO #1 and CPO #2. Further video footage review revealed RN #1 walked away from the patient's room and did not stay to monitor the patient and supervise the situation when CPO and Security staff placed the patient in a physical restraint.

Personnel file review for CPO #1 revealed no documentation the CPO had completed NCI (Nonviolent Crisis Intervention: training program that teaches deescalation and therapeutic patient hold techniques). File review revealed no documentation the CPO had received hospital based restraint training.

Interview was requested with and declined by CPO #1. Review of hospital investigation documents revealed documentation of an interview on 05/19/2011 of CPO #1 by Root Cause Analysis team members. Review revealed, when CPO #1 was asked who has authority to place a patient in physical restraints, he responded officers not allowed, nurses don't know how. Review revealed, when CPO #1 was asked what he does when a patient starts to escalate and how he was trained in de-escalating patients, his response was documented by the interviewer as "Put arms across jaw to keep his head turned away. Patient blubbering, blowing foam and spit. Patient quit moving. Patient still breathing. Moved to stretcher. Put restraints on legs. Moved to arms and LPN noticed he wasn't breathing. Patient arched back and took one big breath. Training: soft hands - pain compliance; no marks left but cause pain; wrist lock; and nerve under jaw. hard hands - punches".

Personnel file review for CPO #2 revealed no documentation the CPO had completed NCI. File review revealed no documentation the CPO had received hospital based restraint training.

Interview was requested with and declined by CPO #2. Review of hospital investigation documents revealed documentation of an interview on 05/12/2011 of CPO #2 by Root Cause Analysis team members. Review revealed, when CPO #2 was asked what he does when a patient starts to escalate and how he was trained in de-escalating patients, his response was documented by the interviewer as "Training: No department training. As Police Officer get: hand cuff training, unarmed self-defense training (how to grab wrists and arms to gain control), painful force training, and training to de-escalate situation includes verbal, soft hands, equipment to include pepper spray and use of baton (depends on how it escalates)". Review revealed, when CPO #2 was asked who has authority to place a patient in physical restraints, he responded that he now knew, based on an e-mail that recently came out, that medical staff (nurses and physicians) can place leather restraints.

Interview on 10/18/2011 at 1330 with the Company Police Captain/Supervisor revealed the CPO staff began receiving Crisis Intervention Training (CIT) in the spring of 2011. Interview revealed the purpose of CIT training was to help CPO staff identify mental illnesses and train them in how to respond to mentally ill patients, including verbal de-escalation techniques. Interview revealed CIT training did not include training for therapeutic patient holds. Interview revealed CPO #1 had not yet attended CIT class. Further interview revealed CPO staff were not required to and did not receive NCI training. Interview revealed, "Unless they've attended classes in addition to police training, there isn't any specific training for that (therapeutic patient holds) for Company Police Officers. They use law enforcement training for physical holds." Further interview revealed CPO staff do not receive hospital restraint training. Interview revealed when CPO staff is hired, a supervisor or experienced field training officer goes through the orientation checklist and verbally addresses each item with the officer. Interview revealed the supervisor or training officer typically informs the CPO when they assist with a patient's restraint, they don't apply the restraints, but rather hospital staff does. Interview revealed CPO staff are instructed to hold the patient's limb and help at the direction of staff.

Personnel file review for RN #1 revealed the staff member was hired on 12/04/2000 and became a registered nurse during 2005 and remained employed at the hospital. File review revealed the nurse worked in the ED until 05/21/2011, at which time she moved and terminated employment. File review revealed no documentation the nurse received NCI training during her employment at the hospital.

Interview on 10/19/2011 at 1215 with the Service Line Director of Emergency Services revealed NCI (Nonviolent Crisis Intervention training) is required for all permanent ED staff within a year of hire.

Interview on 10/19/2011 at 1510 with the Vice President of Nursing confirmed there was no documentation that RN #1 received NCI training during her employment at the hospital.




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2. Closed medical record review for patient #2 revealed a 42 year old male presenting to the hospital's Emergency Department (ED) via Emergency Medical Services on 04/24/2011 at 0203 involuntarily committed (IVC) for a psychiatric evaluation. Record review of Nurse # 5's notes dated 04/24/2011 at 0650 revealed "Late entry (not timed) PT became extreamly (extremely) agitated unable to verbally deescalate. PT pacing and shouting in room. Unable to obtain additional orders. Pt charged from room and begain (began) thoughing (throwing) his body against the doors tot he (of the) unit. With assistance of Security Guard # 3 and CPO (Company Police Officer) # 2 PT was placed in a threaputic (therapeutic) hold and assited (assisted) to the floor. As to prevent harm to self." Record review revealed Security Guard #3 and CPO #2 assisted Nurse #5 in the therapeutic hold of patient #2.

Review of Hospital's Security Company's document titled "INCIDENT/INVESTIGATION REPORT" prepared by CPO #2 and dated 04/24/2011 revealed "On Sunday April 24th, 2011 at approximately 0500 hrs while in the psychiatric department patient in room 66 came combative to where he attempted to escape the psychiatric department through the double doors. Physical force had to be used to retain the patient. Further review of report revealed narrative continued stating "...(Patient #2) tried to leave through double doors...by hitting and kicking the doors... (CPO #2) along with Security Officer #3, Nurse #5, and Security Officer #4 used soft hands on Mr.(Patient #2) so that lay him on to the floor so that we could better restrain the patient. After the patient was restrained and under control I placed my handcuffs onto the patient so that (Patient #2) wouldn't injury himself or any others. At no time did I, security or medical staff strike Mr (Patient #2) and Mr (Patient #2) did not strike any of us..." Report review revealed Patient #2 was restrained on the floor by Nurse #5, Security Officers #3 and #4, and CPO #2. Report review revealed CPO #2 placed handcuffs on Patient #2.

Personnel file review for RN #5 revealed the staff was a contracted agency nurse that began work as a psychiatric nurse in the ED on 02/07/2011. File review revealed the nurse's contract expires on 11/26/2011. File review revealed no documentation the nurse received NCI (Nonviolent Crisis Intervention) training skill training during his employment at the hospital.

Interview on 10/19/2011 at 0950 with RN #5 revealed the nurse had not received NCI training or other nonphysical intervention skill training in many years. Interview revealed the nurse was aware NCI training was offered at the hospital, but he had not been required to take it.

Interview on 10/19/2011 at 1215 with the Service Line Director of Emergency Services revealed NCI is required for all permanent ED staff within a year of hire. Interview revealed NCI training was not mandatory for agency nursing staff. Interview revealed, "They come in with stated experience and competency in all ED and critical care areas. That's considered their competencies." Further interview revealed the agency checklist of competencies did not include de-escalation techniques, NCI, or therapeutic holds.

Interview on 10/19/2011 at 1510 with the Vice President of Nursing confirmed there was no documentation that RN #5 received NCI training during his employment at the hospital.

Personnel file review for CPO #2 revealed the CPO was hired on 02/15/2011 by the security company contracted by the hospital and provided police services at the hospital until 09/29/2011, at which time he was reassigned elsewhere by the security company. File review revealed no documentation the CPO had completed NCI. File review revealed no documentation the CPO had received hospital based restraint training.

Interview on 10/18/2011 at 1330 with the Company Police Captain/Supervisor revealed the CPO staff began receiving Crisis Intervention Training (CIT) training in the spring of 2011. Interview revealed the purpose of CIT training was to help CPO staff identify mental illnesses and train them in how to respond to mentally ill patients, including verbal de-escalation techniques. Interview revealed CIT training did not include training for therapeutic patient holds. Interview revealed CPO #2 had not yet attended CIT class. Further interview revealed CPO staff were not required to and did not receive NCI training. Interview revealed, "Unless they've attended classes in addition to police training, there isn't any specific training for that (therapeutic patient holds) for Company Police Officers. They use law enforcement training for physical holds." Further interview revealed CPO staff do not receive hospital restraint training. Interview revealed when CPO staff is hired, a supervisor or experienced field training officer goes through the orientation checklist and verbally addresses each item with the officer. Interview revealed the supervisor or training officer typically informs the CPO when they assist with a patient's restraint, they don't apply the restraints, but rather hospital staff does. Interview revealed CPO staff are instructed to hold the patient's limb and help at the direction of staff.

3. Closed medical record review for patient #7 revealed a 42 year old male presenting to the hospital's Emergency Department (ED) on 06/29/2011 at 2011 with complaints of neck and back pain. Record review revealed the patient was discharged on 06/30/2011 at 1451 with diagnoses UTI (Urinary Tract Infection) and alcohol intoxication. Record review of Nurse #7 notes dated 06/30/2011 at 0848 revealed "...Pt (patient #7) found to have attempted to leave the ED. Pt escorted back to room 31...Pt stated he wanted to leave and smoke. Pt began swinging and acting out in the lobby. pt had to be taken to the floor by room 31 by security and panic alarm sounded by staff. Pt then proceeded to head butt the glass door of room 31..." Record review revealed no documentation of how the patient was "taken to the floor" or who participated in the taking the patient to the floor.

Review of hospital's Security Company's document titled "INCIDENT/INVESTIGATION REPORT" dated 06/30/2011 revealed a narrative by CPO #4 stating, "On Thursday June 30, 2011 at approximately 0830 hours I responded to blue zone room #31 in reference to an involuntarily committed white male (patient #7)...attempting to leave by fighting with Security Personnel and Medical staff. When I arrived on scene Security Officer's and Medical staff were laying on (Patient #7) in an attempt to gain control...(Patient #7) became verbally uncooperative but got up off the floor and went into his room and sat down on his bed. (Security Officer #5) and I were standing outside the room obtaining information...when (Patient #7) jumped off his bed throwing his body and arms into the glass door of his room and sat back down on the bed. Approximately three or four minutes later (Patient #7) came out of his room and said "arrest me I want you to (expletive) arrest me." I informed (Patient #7) he was not under arrest but could not leave due to being involuntarily committed and attempted to walk him back to his room. I asked (Patient #7) to sit down and relax on his bed. (Patient #7) out his finger in my face and stated "(expletive) you get out of my face and my (expletive) room". Once again I told (Patient #7) to relax. (Patient #7) pushed my chest and said "(expletive) you make me lay the (expletive) down and pushed me again. I attempted to gain control of (Patient #7)'s hands to keep from being pushed again when he became combative and resistant to my commands. Security Officer #5 entered the room along with Nurse #8 to assist me in gaining control of (Patient #7). (Patient #7) started thrashing and attempted to grab my handcuffs to prevent being handcuffed to the bed putting nicks and cuts on my fingers. Approximately ten to twelve minutes later I told (Patient #7) I would take him out of handcuffs if he agreed to cooperate with medical staff. (Patient #7) agreed. I took (Patient #7) out of handcuffs without further incident."

Interview on 10/21/2011 at 1300 with CPO #4 revealed "(Patient #7) was back in his room when I saw him...he was running into the glass, attempting to hit, biting, spitting, cursing and threatening staff...(Nurse #8) and (Security #5) were not going to take action..." Interview revealed Nurse #8 and Security Officer #5 were in the patient's room when CPO #4 handcuffed the patient. Interview revealed "When he attempted to assault me, that was the end of it." Interview revealed CPO #4 placed a handcuff on the patient and with the other cuff secured the patient to the bed.

Personnel file review for CPO #4 revealed the CPO was hired on 10/19/2010 by the security company contracted by the hospital and provided police services at the hospital through the present time. File review revealed the CPO attended CIT class on 03/04/2011. File review revealed no documentation the CPO had completed NCI. File review revealed no documentation the CPO had received hospital based restraint training.

Interview on 10/18/2011 at 1330 with the Company Police Captain/Supervisor revealed the CPO staff began receiving Crisis Intervention Training (CIT) training in the spring of 2011. Interview revealed the purpose of CIT training was to help CPO staff identify mental illnesses and train them in how to respond to mentally ill patients, including verbal de-escalation techniques. Interview revealed CIT training did not include training for therapeutic patient holds. Further interview revealed CPO staff were not required to and did not receive NCI training. Interview revealed, "Unless they've attended classes in addition to police training, there isn't any specific training for that (therapeutic patient holds) for Company Police Officers. They use law enforcement training for physical holds." Further interview revealed CPO staff do not receive hospital restraint training. Interview revealed when CPO staff is hired, a supervisor or experienced field training officer goes through the orientation checklist and verbally addresses each item with the officer. Interview revealed the supervisor or training officer typically informs the CPO when they assist with a patient's restraint, they don't apply the restraints, but rather hospital staff does. Interview revealed CPO staff are instructed to hold the patient's limb and help at the direction of staff.

Based on policy review, personnel file review, and staff interview, the hospital failed to ensure Emergency Department and Contracted Security staff were trained in the use of nonphysical intervention skills for 5 of 16 sampled Emergency Department and Contracted Security staff (Company Police Officer [CPO] #1, CPO #2, Registered Nurse [RN] #1, RN #5, and RN #6).

The findings include:

Review of hospital policy entitled "Restraints, Seclusion, and Safety Devices" dated 06/28/2010 revealed, "PROCEDURES:....2. TRAINING: Hospital staff involved in meeting the patient's needs are educated upon hire before they participate in the use of seclusion/restraint and annually thereafter. Training can be completed via didactic class or online self-study with successful completion of a post-test and competency. Hospital staff includes personnel from the following areas: Nursing,...Security,....Training Requirements Include: a. The underlying causes of threatening behavior. b. Less restrictive alternative. c. Proper and safe application/removal...of restraints. d. Monitoring patient's physical/psychological status....4. Less Restrictive Alternatives: Attempts are made to evaluate and/or consider interventions/alternatives such as:...b. Environmental Measures: i. Decrease stimulation; quiet surroundings....c. Comfort Measures:....iv. Gentle touch, soothing voice....f. Diversional Activities: i. Distract patient with videos, TV, photographs, radio, reading materials, engage in conversation....iii. Provide alternative activity for hands, i.e. rubber ball, squeezing devices, etc....h. Interpersonal Skills: i. Pleasant, consistent interaction with patient....ii. Actively listen to patient, calm reassurance....i. Communication/Interpersonal Relationships....iv. Respect a patient's need for personal space...."

1. Personnel file review for CPO #1 revealed the CPO was hired on 01/30/2007 by the security company contracted by the hospital and provided police services at the hospital until 09/29/2011, at which time he was reassigned elsewhere by the security company. File review revealed no documentation the CPO had completed NCI or other nonphysical intervention skill training.

Interview on 10/18/2011 at 1330 with the Company Police Captain/Supervisor revealed the CPO staff began receiving Crisis Intervention Training (CIT) in the spring of 2011. Interview revealed the purpose of CIT training was to help CPO staff identify mental illnesses and train them in how to respond to mentally ill patients, including verbal de-escalation techniques. Interview revealed CPO #1 had not yet attended CIT class. Further interview revealed CPO staff were not required to and did not receive NCI training.

2. Personnel file review for CPO #2 revealed the CPO was hired on 02/15/2011 by the security company contracted by the hospital and provided police services at the hospital until 09/29/2011, at which time he was reassigned elsewhere by the security company. File review revealed no documentation the CPO had completed NCI or other nonphysical intervention skill training.

Interview on 10/18/2011 at 1330 with the Company Police Captain/Supervisor revealed the CPO staff began receiving Crisis Intervention Training (CIT) in the spring of 2011. Interview revealed the purpose of CIT training was to help CPO staff identify mental illnesses and train them in how to respond to mentally ill patients, including verbal de-escalation techniques. Interview revealed CPO #2 had not yet attended CIT class. Further interview revealed CPO staff were not required to and did not receive NCI training.

3. Personnel file review for RN #1 revealed the staff member was hired on 12/04/2000, became a registered nurse during 2005, and remained employed at the hospital. File review revealed the nurse worked in the ED until 05/21/2011, at which time she moved and terminated employment. File review revealed no documentation the nurse received NCI training or other nonphysical intervention skill training during her employment at the hospital.

Interview on 10/19/2011 at 1215 with the Service Line Director of Emergency Services revealed NCI is required for all permanent ED staff within a year of hire.

Interview on 10/19/2011 at 1510 with the Vice President of Nursing confirmed there was no documentation that RN #1 received NCI or other nonphysical intervention skill training during her employment at the hospital.

4. Personnel file review for RN #5 revealed the staff was a contracted agency nurse that began work as a psychiatric nurse in the ED on 02/07/2011. File review revealed the nurse's contract expires on 11/26/2011. File review revealed no documentation the nurse received NCI training or other nonphysical intervention skill training during his employment at the hospital.

Interview on 10/19/2011 at 0950 with RN #5 revealed the nurse had not received NCI training or other nonphysical intervention skill training in many years. Interview revealed the nurse was aware NCI training was offered at the hospital, but he had not been required to take it.

Interview on 10/19/2011 at 1215 with the Service Line Director of Emergency Services revealed NCI is required for all permanent ED staff within a year of hire. Interview revealed NCI training was not mandatory for agency nursing staff. Interview revealed, "They come in with stated experience and competency in all ED and critical care areas. That's considered their competencies." Further interview revealed the agency checklist of competencies did not include de-escalation techniques, NCI, or therapeutic holds.

Interview on 10/19/2011 at 1510 with the Vice President of Nursing confirmed there was no documentation that RN #5 received NCI or other nonphysical intervention skill training during his employment at the hospital.

5. Personnel file review for RN #6 revealed the staff was a contracted agency nurse that began work in the ED in 11/2010. File review revealed nurse is currently working in the ED. File review revealed no documentation the nurse received NCI training or other nonphysical intervention skill training during his employment at the hospital.

Interview on 10/19/2011 at 1215 with the Service Line Director of Emergency Services revealed NCI is required for all permanent ED staff within a year of hire. Interview revealed NCI training was not mandatory for agency nursing staff. Interview revealed, "They come in with stated experience and competency in all ED and critical care areas. That's considered their competencies." Further interview revealed the agency checklist of competencies did not include de-escalation techniques, NCI, or therapeutic holds.

Based on policy review, restraint log review, staff interview, adverse event report review, and hospital investigative document review, the hospital failed to implement and maintain an effective quality assessment and performance improvement program to ensure the safety of patients.

The findings include:

1. The hospital failed to have a system in place to evaluate and analyze the use of physical restraints in the Emergency Department.

~cross refer to 482.21(a)(2) QAPI Standard: Tag A0267

2. The hospital failed to analyze reported incidents of patient restraint by Company Police Officers (CPO) to ensure safe and appropriate patient restraints for 2 of 3 sampled reported incidents of patient restraint by CPO.

~cross refer to 482.21(c)(2) QAPI Standard: Tag A0287

3. The hospital failed to implement actions to improve the safety of patients placed in physical restraints after the hospital's analysis of an incident of patient harm during physical restraint identified areas of needed improvement for 1 of 1 sampled incidents of patient harm during physical restraint.

~cross refer to 482.21(c)(2) QAPI Standard: Tag A0288

Based on policy review, restraint log review, and staff interview, the hospital failed to have a system in place to evaluate and analyze the use of physical restraints in the Emergency Department.

The findings include:

Review of hospital policy entitled "Restraints, Seclusion, and Safety Devices" dated 06/28/2010 revealed, "...DEFINITIONS: 1. RESTRAINT - A manual method, physical or mechanical device,...that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely....PROCEDURES:....21. PERFORMANCE IMPROVEMENT: A Central Log of all patients in restraints is kept by Nursing Performance Improvement. (Name of Hospital) collects data on the use of seclusion and restraint in order to monitor and improve it's performance and process and to understand the root cause of seclusion or restraint, identify trends, evaluate and create alternatives to seclusion or restraint...."

Review on 10/17/2011 of hospital Restraint Logs from April 2011 to October 2011 revealed no documentation of patients that were physically restrained by staff in the Emergency Department (ED).

Interview on 10/19/2011 at 1050 with a Nursing PI (Performance Improvement) Coordinator revealed the Coordinator performs monitoring of the restraint process. Interview revealed when restraint orders are entered into the computer a copy of the order prints on the Coordinator's printer to alert PI staff to the restraint. Interview revealed, "We get a report every 12 hours of all of the restraints that have been ordered. It goes to all resource nurses on each unit, so they can monitor their restraints (concurrent review process)." Interview revealed in addition to the concurrent review, PI does a retrospective review of 5 restraint episodes per unit per month. Interview revealed data from that review is aggregated in a spread sheet and sent to managers and service line directors, who review the information each month. Interview revealed, "We review documentation and utilization (of restraints), the number and area of restraints. We trend to look for an increase or decrease." Interview revealed PI uses the information obtained to look for opportunities for improvement and develops performance improvement plans as necessary. Further interview revealed if an order was not entered into the computer the restraint episode would not show up on the Restraint Log and PI would not review it. Interview revealed, "BHC (Behavioral Health Care) is where I see most of the therapeutic hold (physical restraint) orders. I don't see orders for therapeutic holds in the ED. None of the therapeutic holds are reported to me as restraints, so they are not reviewed as restraints. I do not review therapeutic holds in the ED. If an order was put in then I would review it."

Based on policy review, adverse event report review, hospital investigative document review, and staff interview, the hospital failed to analyze reported incidents of patient restraint by Company Police Officers (CPO) to ensure safe and appropriate patient restraints for 2 of 3 sampled reported incidents of patient restraint by CPO (Patients #2 and #7).

The findings include:

Review of hospital policy entitled "Quality Care Control Report (QCC)" dated 04/25/2011 revealed, "...10. Follow-up process for online reporting: a. A report is generated daily in Corporate Risk Management. b. A member of the Corporate Risk Management support staff then sends individual reports via e-mail to the Manager of the location listed. The e-mail indicates if a written response is due based, on the incident type reported....c. If requested, the Manager responds to the Corporate Risk Manager with the follow-up via e-mail....d. Corporate Risk Management support staff enters the response...and closes the report. e. Additional inquiry or investigation of the patient event may be taken by or at the direction of (Hospital) Director of Corporate Risk Management or designee...in accordance with the Director's responsibility to the Patient Safety Performance Improvement Team..."

1. Review on 10/17/2011 of a hospital's adverse event report (QCC), dated 04/24/2011, involving Patient #2 revealed on 04/24/2011 at 0500 Nurse #5 sustained a "minor injury" as a result of a "fall-hallway". Report revealed the incident occurred during a "Therapeutic Hold". Report further revealed, "...Nurse acquired minor injuries while trying therapeutic holds on aggressive patient which quickly escalated. Multiple reports to physician for early intervention produced no orders for chemical or physical restraints. Provider reporting completed through medical review. ED nursing administration currently working with provider staff to create new policy and procedure concerning agitated and destructive patients to prevent further incidents."

Review on 10/21/2011 of a second QCC report, dated 04/24/2011 and reported by Security Officer #3, revealed "Type: Patient Assistance Provided by Security...Comments: At about 0450 (Patient #2) started yelling and coming out of his room the nurse (Nurse #5) and myself attempted to put him back in his room he hit the door, and CPOs (Company Police Officers) and (CPO #2) responded and handcuffed the patient....Attending Physician (#3) stated to put the pt., in leather restraints at 0515 verbally, he requested that the medication be given to the pt., while he was on the floor before he was put in restraints, pt was assessed by staff, and at 0517 taken to bluezone 29 still in restraints."

Review of Hospital's Security Company's document titled "INCIDENT/INVESTIGATION REPORT" prepared by CPO #2 and dated 04/24/2011 revealed "...(Nurse #5) HEAD STRUCK WALL DURING PHYSICAL ALTERCATION (with Patient #2)..." Report review revealed a narrative stating "On Sunday April 24th, 2011 at approximately 0500 hrs while in the psychiatric department patient in room 66 came combative to where he attempted to escape the psychiatric department through the double doors. Physical force had to be used to retain the patient....(Patient #2) tried to leave through double doors...by hitting and kicking the doors... (CPO #2) along with Security Officer #3, Nurse #5, and Security Officer #4 used soft hands on Mr.(Patient #2) so that lay him on to the floor so that we could better restrain the patient. After the patient was restrained and under control I placed my handcuffs onto the patient so that (Patient #2) wouldn't injury himself or any others. At no time did I, security or medical staff strike Mr (Patient #2) and Mr (Patient #2) did not strike any of us. Medical staff arrived and administered medication...by giving him an injection in his left arm and left buttocks that would help calm him down...walked the patient back to room 66 until a stretcher arrived so that four point's restraints could be placed on the patient by medical staff...(Patient #2)'s vitals and heart rate were monitored after the incident by medical staff...(Patient #2) had an elevated heart rate and was moved out of the Psych area into treatment room 29 so that he could be monitored more closely. (Nurse #5) fell against the wall striking his head during the physical altercation." Report review revealed Patient #2 was restrained on the floor by Nurse #5, Security Officers #3 and #4, and CPO #2. Report review revealed CPO #2 placed handcuffs on Patient #2.

Interview on 10/19/2011 at 1200 with Nursing Administration revealed "(Physician #4) stated there is too much variation with psych patients to have any standard protocols or orders for these patients." Interview revealed as of survey date there were no new policies and procedures concerning agitated and destructive patients implemented in the ED.

Interview on 10/21/2011 at 1330 with Performance Improvement (PI) staff revealed the QCC report and Security Investigation reports regarding the incident of Patient #2 being handcuffed by CPO staff were sent to Risk Management. Interview revealed Risk Management did not send either report to Performance Improvement, and thus a quality/PI review was not completed.

2. Review of hospital's Security Company's document titled "INCIDENT/INVESTIGATION REPORT" prepared by CPO #4 and dated 06/30/2011 revealed "...Patient (#7) was combative, resistant and attempted to grab equipment on officers duty belt...." Review of document revealed a narrative by CPO #4 stating, "On Thursday June 30, 2011 at approximately 0830 hours I responded to blue zone room #31 in reference to an involuntarily committed white male (patient #7)...attempting to leave by fighting with Security Personnel and Medical staff. When I arrived on scene Security Officer's and Medical staff were laying on (Patient #7) in an attempt to gain control. I was informed by (Nurse #8) that (Patient #7) was involuntarily committed and may still be intoxicated. I told (Patient #7) he needed to allow medical staff to help him and that he could not leave. (Patient #7) became verbally uncooperative but got up off the floor and went into his room and sat down on his bed. (Security Officer #5) and I were standing outside the room obtaining information...when (Patient #7) jumped off his bed throwing his body and arms into the glass door of his room and sat back down on the bed. Approximately three or four minutes later (Patient #7) came out of his room and said 'arrest me I want you to (expletive) arrest me.' I informed (Patient #7) he was not under arrest but could not leave due to being involuntarily committed and attempted to walk him back to his room. I asked (Patient #7) to sit down and relax on his bed. (Patient #7) put his finger in my face and stated '(expletive) you get out of my face and my (expletive) room'. Once again I told (Patient #7) to relax. (Patient #7) pushed my chest and said '(expletive) you make me lay the (expletive) down' and pushed me again. I attempted to gain control of (Patient #7)'s hands to keep from being pushed again when he became combative and resistant to my commands. Security Officer #5 entered the room along with Nurse #8 to assist me in gaining control of (Patient #7). (Patient #7) started thrashing and attempted to grab my handcuffs to prevent being handcuffed to the bed putting nicks and cuts on my fingers. Approximately ten to twelve minutes later I told (Patient #7) I would take him out of handcuffs if he agreed to cooperate with medical staff. (Patient #7) agreed. I took (Patient #7) out of handcuffs without further incident."

Interview on 10/21/2011 at 1330 with Performance Improvement (PI) staff revealed the Security Investigation report regarding the incident of Patient #7 being handcuffed by CPO staff was sent to Risk Management. Interview revealed Risk Management did not send the report to Performance Improvement, and thus a quality/PI review was not completed.

Based on policy review, adverse event report review, hospital investigative document review, and staff interview, the hospital failed to implement actions to improve the safety of patients placed in physical restraints after the hospital's analysis of an incident of patient harm during physical restraint identified areas of needed improvement for 1 of 1 sampled incidents of patient harm during physical restraint (Patient #5).

The findings include:

Review of hospital policy entitled "Sentinel Events and Root Cause Analysis" dated 08/22/2011 revealed, "...PURPOSE: To improve care, maintain a safe environment, and focus attention on the underlying causes to promote risk reduction...DEFINITIONS:... Sentinel Event: A Sentinel Event is an unexpected occurrence involving death, serious physical...injury,....Root Cause Analysis (RCA): A process for identifying the basic or causal factor(s) that underlies variation in performance, including the occurrence or possible occurrence of a Sentinel Event....A goal of the analysis is to identify and prioritize opportunities to improve the process and reduce the risk of the Sentinel Event or near miss reoccurring....Action Plan: The product of a RCA....The action plan addresses system and process deficiencies for which improvement strategies are developed and implemented....The goal of the action plan is to find ways to prevent a repeat of Sentinel Events, occurrences, or near misses....GUIDELINES:...Root Cause Analysis (RCA):....2. The RCA Team looks at the systems/processes involved in the occurrence and identifies and documents the root causes thought to be contributing to the event....The RCA Team develops an action plan that includes measures to monitor plan effectiveness....Recommendations targeted at the root causes are developed to significantly reduce the likelihood of recurrence of the event....5. Action plans are forwarded to the HEAT (Harm and Events Analysis Team) or Quality Council for evaluation and approval for implementation by (Hospital) departments identified in the action plan. The HEAT establishes deadlines for completion of the action plans...."

Review of an adverse event report dated 04/17/2011 revealed, "...Comments: (Patient #5) brought in by EMS at 4:40pm and put in red zone room 65 (in locked psychiatric area of ED). The whole time the patient was in room 65 he was agitated, and confused. The psychiatrist saw patient and involuntarily committed him. The patient was medicated by day shift but continued to be agitated. After shift change the on coming ED (nurse tried to get) patient in a hospital gown. The nurse medicated patient by shot, Company police officers (CPO #1) and (CPO #2), and Security officer (SO #2) were standing by. Patient continued to be agitated so I called for CPO's assistance. The CPO's went into patients room to try and calm him, patient then became combative, and was taken down by CPO's and security. (SO #1) called for more assistance and medical and psych staff arrived, everyone assisted in getting patient into bed so he could be restrained. After patient was in the bed a nurse said that something was wrong with the patient he wasn't breathing. Patient was then rushed to the resuscitation room....Entered by: (SO #1)...."

Review of hospital investigative documentation revealed a RCA was conducted and concluded on 06/20/2011. Review of the RCA report revealed, "...Root Cause Analysis/Failure Scenario: The root cause was identified as no clinical person in charge of the patient's care and well being. The contributing factors were:...2. Clinical staff relinquished responsibility for the patient's care to Security and CPOs. 3. Law enforcement techniques were utilized versus therapeutic interventions as outlined in non-violent crisis intervention (NCI) training. 4. The patient's assigned nurse was not trained in NCI...." Further review of the RCA report revealed the following recommendations: 1. formation of an integrated team (including physicians, nurses, mental health specialist, security, and a licensed clinical social worker) to function solely in the Psychiatric ED - to be completed within 3 months; 2. ensure all ED staff receive NCI training - to be completed within 3 months; 3. administrative and risk management staff to evaluate whether the hospital wants law enforcement techniques used on patients - to present recommendations to HEAT team within 1 month; 4. develop a Code White (behavioral emergency response) team - within 3 months; and 5. Re-examination of the RCA to be completed by the HEAT team after the patient's autopsy report is received and examined regarding cause of death and proved further recommendations as warranted.

Interview on 10/21/2011 at 1455 with the Vice President of Nursing, with the Director of Performance Improvement present, revealed the hospital had attempted to implement the integrated team model, but because of difficulty recruiting appropriate staff (psychiatric nurses and licensed clinical social workers [LCSW]) the implementation was not completed. Interview revealed two LCSW staff were hired in August, but one resigned before starting employment and the other one worked briefly and was terminated from employment due to performance. Interview revealed currently the hospital was working towards changing the nursing model in the psychiatric ED so that the psychiatric nurse would assume the role of primary nurse, rather than consultant nurse. Interview revealed the goal for completion was 03/30/2012. Interview revealed on 04/30/2011, the hospital began to have additional NCI classes, which are ongoing in an attempt to ensure all ED staff were trained. Interview revealed a few staff members were currently not trained. Regarding recommendation #3 ("administrative and risk management staff to evaluate whether the hospital wants law enforcement techniques used on patients"), interview revealed, "This was not started initially, but I put it in my updated plan this week. It was assigned to the Vice President of Post Acute Care and the Director of Risk Management...I addressed it more futuristically." Interview revealed there had been no change in the process of which staff (including CPO staff) were allowed to put physical restraints on patients prior to the survey. Interview revealed, after HEAT team further evaluated the implementation of a Code White team, it was decided that it was not feasible to implement and the hospital's current Code White process was sufficient and would thus continue. Interview revealed no further actions were implemented after the patient's autopsy report was received on 09/07/2011.

Based on policy review, medical record review, video taped footage review, staff interview, and hospital investigation document review, the hospital failed to have an organized nursing service providing oversight of day-to-day operations to ensure registered nursing staff supervised and evaluated patient care and ensure nursing staff were trained and competent to ensure the safe and appropriate physical restraint of patients.

The findings include:

1. The hospital's nursing staff failed to supervise and evaluate patient care during patient restraint.

~cross refer to 482.23 (b)(3) Nursing Services Standard: Tag A0395

2. The hospital failed to ensure nursing staff were trained and competent to ensure the safe and appropriate physical restraint of patients.

~cross refer to 482.23 (b)(5) Nursing Services Standard: Tag A0397

Based on policy review, medical record review, video taped footage review, staff interview, and hospital investigation document review, the hospital's nursing staff failed to supervise and evaluate patient care during restraint for 3 of 11 sampled patients that were restrained by staff (Patients #5, #7, and #2).

The findings include:

Review of hospital policy entitled "Restraints, Seclusion, and Safety Devices" dated 06/28/2010 revealed, "POLICY:...The type or technique of restraint or seclusion is the least restrictive intervention that is effective to protect the patient, a staff member or others from harm....DEFINITIONS: 1. RESTRAINT - A manual method, physical or mechanical device, material or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely....7. INITIATION & ASSESSMENT: A qualified licensed staff member with established competencies may initiate seclusion or apply restraint. Assessment of the patient who has new onset or worsening of confusion/agitation is done by an RN (registered nurse) prior to or within 30 minutes of application of a restraint....11. RESTRAINT/SECLUSION MONITORING:...Behavioral Seclusion/Restraint: Staff provides continuous face-to-face observation of the patient in rigid limb restraint(s) and maintains documentation on the Restraint Flowsheet (excluding therapeutic holds less than 15 minutes) and on the Special Observation Flowsheet....At the initiation of seclusion or restraint, and every 15 minutes, a staff member monitors the patient with the intent to prevent harm and maintain well-being....15. DOCUMENTATION:...Each episode of restraint/seclusion use is recorded in the medical record. Documentation includes: a. The circumstances that led to their use; b. Consideration or failure of non-physical less restrictive interventions; c. Medical conditions or physical disability that would place the patient at greater risk....d. The rationale for the type of physical intervention selected; e. The type of restraint used,...vital signs, circulation to extremities,...patient response to treatment, patient rights, dignity and privacy maintained, and time released...h. Behavior criteria for release...; i. Informing the patient of behavior criteria for release from restraint...; l. Injuries that are sustained and treatment received for these injuries; and m. Deaths..."

1. Closed record review for Patient #5 revealed a 27 year-old male with a history of schizophrenia presented to the Emergency Department (ED) via Emergency Medical Services (EMS) on 04/17/2011 at 1638 with complaints of not taking his medicine. Record review revealed upon arrival the patient was placed in Room 65 (within the locked psychiatric area of the ED). Record review revealed the psychiatrist evaluated the patient and he was then involuntarily committed (IVC). Review of RN #1's note at 1929 revealed, "Assumed patient care. Patient awake and alert, breathing even and unlabored. Patient stares at RN, nonverbal. No response to questions or requests. Patient is INVOL(untary)." Review of RN #1's note at 1951 revealed, "Patient more verbal at this time, answering questions. Patient requested water; provided. patient continues to refuse to change into gown." Review of RN #1's note at 2017 revealed, "Patient continued to refuse gown, now stating ' I want my momma. I'm not putting on no mother (expletive) gown'. Patient more active in room, pacing. Patient multiple trips back and forth to bathroom; not following directions of security or nurse. CPO (Company Police Officer) and security to bedside; patient medicated." Review of RN #1's note at 2110 revealed, "Patient pacing in hallway, appears to becoming more agitated. Refusing to stay in room, becoming aggressive with staff. (RN #2) from Psych ED aware of patients increasing agitation; will inform (Physician #2)." Review of RN #1's note at 2120 revealed, "Patient now states he is leaving, attempting to walk to double doors. When patient informed that he must stay in room he became very angry. States 'I need some water'. Patient then picks up water and proceeds to pour water on all staff member. Patient instructed to stop by CPO and water taken from patient. Patient then attempts to leave room and begins to push and punch staff. Patient instructed to stop, refused. At this time patient was restrained by CPO and security. This RN then left area to inform Psychiatrist of situation. Upon returning to Psych area security states that patient has stopped resisting. When patient was moved to stretcher he was noted to have agonal respirations. Patient moved to resus(citation) room at this time." Review of RN #1's note at 2125 revealed, "Patient was being bagged with BVM (bag-valve mask). Upon arrival to resus room patient was pulseless, asystole on monitor; CPR (cardiopulmonary resuscitation) started." Review of RN #1's note at 2217 revealed, "Resuscitation attempts unsuccessful; efforts stopped. TOD (time of death) 2211." Record review revealed patient's body was sent to the Office of the Chief Medical Examiner for autopsy. Review of the "Report of Autopsy Examination" dated 09/06/2011 and signed by a physician from the Medical Examiner's office revealed, "Date of Exam 04/18/2011....SUMMARY AND INTERPRETATION....He was being involuntarily committed and was at the local hospital when his death occurred. He was agitated and attempting to leave his room when he was physically restrained by multiple individuals. Video of the events show one person placing an arm around his neck prior to him being taken to the ground. The neck restraint appears to be maintained as several other individuals restrain his body. His respiratory function would have been further compromised if overlay occurred on the chest and/or abdomen. The decedent appears unresponsive immediately following the restraint. Significant findings at autopsy include small, multifocal and thin subarachnoid hemorrhages, hemorrhages in the tongue and laryngeal mucosa and chronic active hepatitis of unknown etiology. Toxicology studies are positive for therapeutic concentrations of Risperidone (Risperdal) in aorta blood. Benzodiazepines, cocaine, ethanol, opiates, organic bases, ziprasidone and haloperidol are not detected. Based on the history and investigative findings, it is my opinion that the cause of death in this case is asphyxia due to restraint."

Review on 10/18/2011 at 1130 and on 10/20/2011 at 1130 of video taped footage of the Psychiatric Area of the ED dated 04/17/2011 and beginning at 2113 revealed two different views were recorded. Review on 10/18/2011 with a staff member from the ED (to identify staff in footage) and legal department staff revealed the camera angle from down the hall that showed Room 65 on the right side of the hall. Review on 10/20/2011 with the Vice President of Nursing and legal department staff revealed the camera angle was from down the hall and looking directly into Room 65. Review of the footage revealed the following events at the noted times:
? 21:13:00 - Patient #5 in room with lights off. CPO #1 and CPO #2 go into patient's room and turn light on. One Security Officer (SO) in room and another SO at the patient's doorway looking into room (SO #1 and SO #2). RN #1 and RN #2 outside of and looking into room. (No nurse in room).
? 21:13:14 - RN #1 goes into room. SO #1 and SO #2 in room and CPO #1 and CPO #2 standing in doorway of room. Patient not in view.
? 21:13:26 - Patient walks into view in front of bed (which is against the back wall). All staff looking at patient. Patient sits on bed.
? 21:13:53 - Patient stands up off of bed with a cup in his hand.
? 21:14:16 - Patient throws water from cup onto a Security Officer (unable to determine which one). CPO reaches for cup.
? 21:14:22 - RN #1 goes out of room and out of view. RN #2 in doorway looking into room. Patient not in view, but can see 2 Security Officers and 1 CPO in room (other CPO is in room out of view). No nurse in room.
? 21:15:21 - Patient moves towards door and CPO #1 moves in front of him (between patient and door). SO #1 and SO #2 outside of and looking into room. RN #1 walks towards room while wiping her shirt with a towel.
? 21:15:22 - CPO #2 walks towards patient (from right side of room) with arms reached out towards patient.
? 21:15:23 - SO #1 and SO #2 move into the patient's doorway. Patient is facing doorway with CPO #1 on his right side and CPO #2 on his left side (both CPOs positioned towards the front of the patient).
? 21:15:25 - RN #1 turns away from the patient's room and walks down the hall. The 2 CPOs are holding the patient's arms, one on each side. (No nurse in room as physical restraint is initiated by CPOs).
? 21:15:26 - Patient lifts up slightly and sits on bed (CPOs still beside of and with hands on the patient).
? 21:15:28 - RN #1 looks over shoulder then turns around and faces the patient's room. SO #1 and SO #2 head into room. CPO #1 leans down towards bed. CPO #2 not in view.
? 21:15:29 - RN #1 turns back away from and continues to walk away from room. Patient is visible standing and facing towards the right side of the room. CPO #1 goes behind the patient. CPO #1 lifts his right arm out with elbow bent and moves it towards the patient.
? 21:15:30 - CPO #1's arm not visible. CPO #1 is leaning forward or bending down. Patient not visible. SO #1 and SO #2 in doorway looking in. CPO #1 and patient go backwards (towards left side of room) together. CPO #2 comes into view with in front of patient with his arms extended, but hands not visible. RN #1 looks back towards room again, then turns and continues to walk away from room.
? 21:15:31 - Patient's right hand is in the doorway, holding onto the door jam. The 2 Security Officers are still in the doorway. Both CPOs face the doorway as they and the patient are going down.
? 21:15:32 - Patient down and out of view. CPO #1 (who was behind patient) is not visible. CPO #2 in front of patient and leaning towards floor. SO #1 and SO #2 enter room and are on the right side of the patient, with their backs towards the camera. The Security Officer closest to the patient's legs is leaning down. (No nurse in room)
? 21:15:35 - CPO #2 leaning down towards patient and out of view. Both Security Officers leaning towards patient, the one near the top of the patient is standing and the one near the patient's legs is leaning towards patient with his (officers) legs extended to the side.
? 21:15:38 - CPO #1 and patient remain out of view. CPO #2 and both Security Officers are leaning towards the left, over the patient.
? 21:15:44 - The Two Security Officers stand, but still lean over the patient.
? 21:15:46 - One of the Security Officers goes around to the patient's other (left) side.
? 21:15:49 - CPO #1 and patient remain out of view. CPO #2 appears to be on the patient's legs.
? 21:15:52 - CPO #2 is up on his toes with his legs extended behind him. The top of his body is positioned towards the patient, but the view is blocked by the back of the Security Officer that is positioned on the patient's right side. (No nurse in room)
? 21:15:53 - Patient's right leg goes up, then down. Security Officer on right side of patient appears to hold it.
? 21:16:03 to 21:16:12 - The footage jumps and there is no footage available during this period of time.
? 21:16:12 - The Security Officer on the right side of the patient and CPO #2, now located near the patient's legs on the right side, are both leaning over the patient with their backs to the door. No one else in the room is visible.
? 21:16:27 - Security Officers and CPOs visible on floor, no apparent struggling at this point. (No nurse in room)
? 21:16:30 - RN #2 and RN #3 (a male psychiatric ED nurse) go to the doorway of the patient's room and look in.
? 21:16:35 - RN #2 goes into room (first time a nurse has been in room since CPOs put hands on patient at 21:15:25).
? 21:16:38 - RN #3 goes into room
? 21:16:42 - RN #3 leans toward patient's feet. CPO #1 now visible and near the top of and to the right of the patient. A Security Officer is visible on each side of the patient.
? 21:16:48 - RN #1 walks to door, drops restraints on the floor in the hall near the door, and turns and walks away from room. RN #2 goes into room and goes to the left side of the room.
? 21:16:54 - Both Security Officers now standing and leaning over patient. CPO #1 is near the top of the patient and is leaning over patient, either on his knees or with his legs extended.
? 21:16:55 - RN #2 leaning over the patient, near his head and to the left of CPO #1, then standing up.
? 21:17:04 - RN #2 comes out of room.
? 21:17:22 - Licensed Practical Nurse (LPN) #1 (an ED nurse) enters room, followed by 1 EMS staff and ED Tech #1. RN #1 is standing in the doorway with restraints in her hand.
? 21:17:48 - Security Officers and other staff are standing looking towards the patient on the floor.
? 21:17:50 - Several staff (unable to determine who or how many) lift the patient from the floor to the bed.
? 21:17:52 - Patient is on bed. Staff, including SO #1, SO #2, and CPO #2, surround the patient. CPO #1 is standing in the doorway.
? 21:17:54 - RN #1 goes into room with restraints in hand.
? 21:17:58 - CPO #1 goes out of room and rubs his head.
? 21:18:30 - Physician #2 (psychiatrist) walks towards room and stops and talks to CPO #1 in the hall on the way.
? 21:18:37 - Physician #2 stands in patient's doorway, leans on doorway, and looks into room. (Does not go into room).
? 21:18:42 - RN #4 (psychiatric nurse) walks towards room and talks to CPO #1 in hall.
? 21:18:49 - RN #3 is standing in room and looking down.
? 21:18:55 - Physician #2 walks away from room. RN #3 mops floor with towel.
? 21:19:02 - Patient is seen laying on bed. Patient is not moving and his clothes are off (can see naked right side).
? 21:19:08 - RN #2 exits room and talks to Physician #2 in hall.
? 21:19:34 - RN #3 exits room and talks to Physician #2 in hall. RN #2 goes back into room.
? 21:19:49 - RN #3 and CPO #1 go into room.
? 21:19:56 - RN #3 exits room. RN #1, RN #2, and LPN #1 are in room near the patient's head. Patient is not moving.
? 21:20:15 - RN #3 goes into room with BP (blood pressure) machine.
? 21:23:26 - Someone takes BP cuff off of patient's arm.
? 21:23:33 - Staff roll patient out of room on bed. He is naked with a sheet laying over his groin. Restraints are visible on his ankles (cannot see his clearly see his wrists). Patient is not moving.

Interview on 10/19/2011 at 1100 with Security Officer (SO) #1 revealed the officer was posted in the psychiatric area of the ED on 04/17/2011 from 4 PM to Midnight and was involved in the physical restraint of Patient #5. Interview revealed, "(When the patient was on the ground) I grabbed his legs and then moved to his arm, I think on the right side. I think the Company Police Officers were on his arms and upper body. As far as I could tell they were leaning on his chest....They had their back to us, so I don't remember if I could see his (the patient's) face or neck." Further interview revealed the officer thought he had to call, by waving his arm so as to be seen on video monitor at the ED desk, to get a nurse in the room. Interview revealed the officer thought someone had pushed the panic button (initiated an emergency response) because "so many" staff showed up. Further interview revealed, "We moved him to the bed. He was still struggling and urinating on himself (when on the floor and the bed). He was moving his arms and legs, trying to get up. He was muttering some stuff....They gave him some shots and tried to put restraints on because he was fighting pretty hard. Before putting restraints on him, they tried to get his clothes off and put a gown on him. I think they got a gown on him, but I'm not sure. Restraints were placed on his arms and legs by medical staff, I'm not sure who...a couple of females and a male. Sometime during that point he quit moving a lot, because they had given him the shots, it usually works pretty quick. That's when the nurse noticed there seems to be something wrong, seems like he's not breathing. She told (RN #2) to go get the bag (BVM). A male nurse checked the pulse and said it was weak. They got him out of there and to the resuscitation room."

Interview was requested with RN #1. Administrative staff informed surveyor RN #1 had moved and was no longer employed at the hospital. Review of hospital investigation documents revealed documentation of a "Witness Statement" for RN #1 dated 04/17/2011. Review of the statement revealed the following: The patient was IVC and began making attempts to leave the facility. He began pacing, cursing, and became physically violent with staff. CPO and security staff were at bedside and intervened when the patient made attempt to leave department and began assaulting staff. While CPO and security were attempting to calm patient, he threw water on staff members and the floor. He then lunged at the CPO and had to be restrained. RN #1 left the area at that time to inform the psychiatrist of the patient's status and events. Upon returning to the area, the patient had stopped resisting CPO and security and was placed on the stretcher. Patient then began to have ineffective breathing and was taken to the resuscitation room.

Interview on 10/18/2011 at 1515 with RN #2 revealed, "The patient made a move towards (CPO #2) so they called the other CPO (#1). I went to his room and he threw water towards staff....I'm not sure if his nurse was in the room. He backed up and said he was sorry and sat on his bed. I went to tell (Physician#2), but he was with another patient. I came back after I told (RN #3) what had happened. I went to the room and he was on the floor on his back...with a CPO towards the upper part of his body on his right side. Somebody had his feet....I don't know who, it was more than one person....He was struggling....I tried to tell him to calm down. I told him we'd let him up if he'd calm down and stop struggling. He was breathing and sweaty, but he was sweaty when he got there. I stepped out and was at the doorway and he stopped struggling. They were in the process of getting him up on the bed. He was a heavy boy....He was making raspy sounds on the bed....They determined he wasn't breathing. The ED nurse told me to go get the bag/mask....When I got back with the bag/mask they called a code and rushed him to the resuscitation room." Further interview revealed the psychiatric nurse works in the ED and also on the behavioral health unit. Interview revealed during a hold a patient should be monitored for breathing and safety. Interview revealed, "If we do a hold on behavioral health (unit) we document on the restraint form. They document differently in the ED."

Interview on 10/19/2011 at 0915 with RN #3 revealed the male nurse was a psychiatric nurse that worked in the ED. Interview revealed when the nurse arrived to the patient's room on 04/17/2011 the patient was on the floor with at least 4 security officers (including security officers and CPOs). Interview revealed, "(CPO #1) was up at the head on the patient's right side helping hold him down. He was holding his chest or head....was in a position to hold the top part of the body. Another person (unsure who) was on the patient's right side holding his right leg. (CPO #2) was on the left side holding his leg or thigh. A security officer...was semi-squatting over (CPO #2)....I held his left foot. A police or security officer was at the top of the left shoulder area. I couldn't see what he was holding. I was just seeing (other staffs') backsides....I think his primary nurse was in the room...but that might have been when I went back and we got him on the stretcher." Interview revealed the nurse wasn't sure what staff monitored the patient's condition during the physical restraint. Interview revealed, "I couldn't see him at all really. He was kicking and fussing and trying to be violent and all of that. I couldn't see his face....All I am seeing is back and arms. They would basically have to be holding him on the chest. He was a big fellow and was doing some pretty good struggling to start with...I could only see him from the knees down because they pretty much had him covered up with their bodies....I stopped holding his foot when he stopped fighting and I went out of the room to get the vital signs machine....I came back in with the vital signs machine and they (staff) were standing up and he didn't look like he was breathing. He had quit fighting. I think (LPN #1) said, 'Let's get him to the stretcher.'...After he was on the stretcher his breathing was very, very shallow....I don't remember his clothes coming off....One (restraint) got put on his leg....There's no point in doing that because he's not breathing right....Everybody's trying to look ahead and get him tied down in case that's what's needed. I got out of the way and they rolled him to the resuscitation room."

Interview on 10/20/2011 at 1245 with ED Technician #1 revealed during April 2011 the staff member worked as an ED Tech(nician), but starting in May 2011 he joined EMS as an Emergency Medical Technician (EMT). Interview revealed on 04/17/2011 the ED Tech went to the patient's room after he heard a radio call for security assistance. Interview revealed, "I went to see what was going on...The patient was standing and there were 2 Company Police Officers telling him to calm down. The patient was cursing and was trying to get out of his room. I left...and later went back over to see if the situation had calmed down. He (the patient) was on the floor. He was kicking and combative. I went to the right, to his feet....I couldn't see his face. They were around him so I couldn't see him....I never heard him say get off me or you're hurting me. He didn't say anything....The only parts (of him) I saw was the legs. I think 3 officers were at the top, I couldn't tell what position or what they were trying to hold....After he calmed down, he was still breathing. I helped lift him to the bed. He was calm and peaceful on the bed. They brought the vital signs machine in and took his vital signs. Then he started going down. Respirations didn't seem right...slow and thready respirations....I left to clear the hallway to move him and to get the resuscitation room ready....I don't remember taking his clothes off or putting restraints on him. He never struggled or fought when he was on the bed. (LPN #1) was at the head of the bed and was directing people....(RN #1) was in the doorway."

Interview was requested with LPN #1. Administrative staff informed surveyor LPN #1 had moved and was no longer employed at the hospital. Review of hospital investigation documents revealed documentation of an interview on 05/18/2011 of LPN #1 by Root Cause Analysis team members. Review of the interview revealed the interviewer documented the nurse's response as, "(RN #1) asked for help with restraints. When I got to the patient's room, he was still on the floor being restrained, but not longer resisting. We got him up on the stretcher, we were getting him straight and trying to get the restraints on and I didn't like his breathing. So, I repositioned his head, still didn't like his breathing. So I asked for a nasal airway. That didn't help, his respirations were decreased, agonal-like. The psych nurse brought the ambu (BVM) bag, but I was concerned about his poor respirations and I said 'We need to go' and we took him to the resuscitation room." Review revealed, when asked was there anything that caused the nurse concern about the case, the interviewer documented the nurse's response as, "I thought they were a little forceful while restraining him and I didn't like them holding him near his head and neck."

Interview on 10/19/2011 at 1215 with the Service Line Director of Emergency Services revealed physical restraints in the ED are usually rapid and temporary, not lasting more than a few minutes, until a patient either calms down or is placed in mechanical restraints. Interview revealed, "The nurse is with the patient the entire time that is happening. A tech can assist, at time security can assist, but we try not to use them. They follow the direction of nursing staff. The nurse should be clinically directing and overseeing that (the physical restraint). (The physically restrained patient) is monitored more often. A behavioral health emergency is the same as a medical emergency.

Interview on 10/20/2011 at 1130 with the Vice President of Nursing during video taped footage review of the physical restraint of Patient #5 on 04/17/2011 confirmed nursing staff was not continuously present and did not continuously supervise the restraint. Further interview confirmed nursing staff did not continuously monitor the patient to ensure safety during the physical restraint.


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2. Closed medical record review for patient #7 revealed a 42 year old male presenting to the hospital's Emergency Department (ED) via private transportation on 06/29/2011 at 2011 with complaints of neck and back pain. Record review revealed the patient was discharged on 06/30/2011 at 1451 with diagnoses UTI (Urinary Tract Infection) and alcohol intoxication. Record review of Nurse #7's notes dated 06/30/2011 at 0848 revealed "...Pt (patient #7) found to have attempted to leave the ED. Pt escorted back to room 31...Pt stated he wanted to leave and smoke. Pt began swinging and acting out in the lobby. pt had to be taken to the floor by room 31 by security and panic alarm sounded by staff. Pt then proceeded to head butt the glass door of room 31..." Record review of physician #4 note dated 06/30/2011 at 0851 revealed "Pt got up, angry, verbally abusive and started to walk out of ED. I explained he could not leave due to ETOH (Alcohol) level. I told him not to leave or I would have to involuntarily commit him until legally sober. Pt came back in with staff escort, then tried to leave again and became combative. Pt now will be involuntarily committed until MBA (Alcohol Level) comes down."

Review of hospital's Security Company's document titled "INCIDENT/INVESTIGATION REPORT" prepared by CPO #4 and dated 06/30/2011 revealed "On Thursday June 30, 2011 at approximately 0830 hours I responded to blue zone room #31 in reference to an involuntarily committed white male (patient #7)...attempting to leave by fighting with Security Personnel and Medical staff....(Patient #7) became verbally uncooperative but got up off the floor and went into his room and sat down on his bed. (Security Officer #5) and I were standing outside the room obtaining information...when (Patient #7) jumped off his bed throwing his body and arms into the glass door of his room and sat back down on the bed. Approximately three or four minutes later (Patient #7) came out of his room and said 'arrest me I want you to (expletive) arrest me.' I informed (Patient #7) he was not under arrest but could not leave due to being involuntarily committed and attempted to walk him back to his room. I asked (Patient #7) to sit down and relax on his bed. (Patient #7) out his finger in my face and stated '(expletive) you get out of my face and my (expletive) room'. Once again I told (Patient #7) to relax. (Patient #7) pushed my chest and said '(expletive) you make me lay the (expletive) down and pushed me again. I attempted to gain control of (Patient #7)'s hands to keep from being pushed again when he became combative and resistant to my commands. (Security Officer #5) entered the room along with (Nurse #8) to assist me in gaining control of (Patient #7). (Patient #7) started thrashing and attempted to grab my handcuffs to prevent being handcuffed to the bed putting nicks and cuts on my fingers. Approximately ten to twelve minutes later I told (Patient #7) I would take him out of handcuffs if he agreed to cooperate with medical staff. (Patient #7) agreed. I took (Patient #7) out of handcuffs without further incident."

Interview on 10/21/2011 at 1200 with nurse #8 revealed, "The patient was trying to leave, (Physician #4) said 'you can't leave I'm going to IVC you'...we did have to do a therapeutic hold...I think I was at the waist, he was taken to the floor and he started to fight...there were 3 or 4 people, maybe, I don't remember...he was down about 20 seconds...I'm not 100% sure if the CPO put hand cuffs on him...we helped him to stand and walked him back to his room...(Physician #4) was there and saw the patient before and after (the hold)..I don't remember (patient #7) head butting the glass..." Interview revealed "...Hand cuffs are restraints when used by duly swore officers, but it is the ultimate responsibility of the nurse to monitor the patient...there are ways to walk a patient back without cuffs...I don't remember him being cuffed to the bed...there was a nurse in the room when I left..."

Further medical record review for Patient #7 revealed no documentation of how long the patient was on the floor, the patient's condition while on the floor, how the patient was held on the floor, what security staff where involved in the hold, or of the use of handcuffs by CPO staff to restrain the patient. Record review revealed patient #7's vital signs were not reassessed until 0952 on 06/30/2011 (1 hour and 4 mins after held to floor and subsequently handcuffed to the bed). Record review revealed no documentation of an assessment of the patient's wrists.

Interview on 10/21/2011 at 1445 with administrative nursing staff confirmed nursing did not reassess the patient's vital signs per policy after a physical restraint/hold or after the patient was handcuffed.

3. Closed medical record review for patient #2 revealed a 42 year old male presenting to the hospital's Emergency Department (ED) via Emergency Medical Services on 04/24/2011 at 0203 involuntarily committed (IVC) for a psychiatric evaluation. Record review of Nurse # 5's notes dated 04/24/2011 at 0456 revealed "...PT continues to be very agitated and begin(n)ing to self inflict. slapping slef (self) over body and arms...No orders given..." Record review revealed ED physician #3 ordered "Restraints-Mechanical...Leather 4 point" on 04/24/2011 at 0501 and "Ziprasidone (medication for short term control of severe agitation) 10 mg Inj (injection)" and "Lorazepam (medication used to calm and treat anxiety) 2 mg IM (intramuscular injection) " on 04/24/2011 at 0502. Record review of " Restraint/Seclusion Orders, " dated 04/24/2011 at 0511, revealed the following types of restraints were ordered by the physician: "Side Rails intended to restrict bed exit...Chemical...RUE (Right Upper Extremity) (rigid), LUE (Left Upper Extremity) (rigid), LLE (Left Lower Extremity) (rigid), RLE (Right Lower Extremity) (rigid)..." Record review of Unit Secretary's note dated 04/24/2011 at 0524 revealed the patient was moved to bed "Blue 26 South" (outside locked Psych Unit). Record review revealed Ziprasidone and Lorazepam, chemical restraints, were administered at 0528 and 0529, respectively, by nurse #6. Record review revealed the 4 point (bilateral wrists and ankles) leather (rigid) restraints were initiated at 0529. Record review of Unit Secretary's note dated 04/24/2011 at 0539 revealed Patient #2 was moved to "RED 63 South" (outside locked Psych Unit). Record review of Nurse #6's notes dated 04/24/2011 at 0551 revealed "Pt moved to room 63 from 29 on stretcher, in 4 point restraints. Pt on cardiac monitor, nibp (blood pressure) cuff and spo2 (Oxygen) monitor. Pt still rocking back in forth in bed from side to side and shaking his legs. Pt sinus tach (tachycardia -elevated heart rate) in 140's - 150's on monitor. (Physician #3) aware." Record review of Nurse # 5's notes dated 04/24/2011 at 0650 revealed "Late entry (not timed) PT became extreamly (extremely) agitated unable to verbally deescalate. PT pacing and shouting in room. Unable to obtain additional orders. Pt charged from room and begain (began) thoughing (throwing) his body against the doors tot he (of the) unit. With assistance of Security Guard # 3 and CPO (Company Police Officer) # 2 PT was placed in a threaputic (therapeutic) hold and assited (assisted) to the floor. As to prevent harm to self." Record review revealed Security Guard #3 and CPO #2 assisted Nurse #5 in the therapeutic hold of patient #2.

Review of Hospital's

Based on policy review, medical record review, video taped footage review, personnel file review, staff interview, and hospital investigation documentation, the hospital failed to ensure nursing staff were trained and competent to ensure the safe and appropriate physical restraint of patients for 2 of 3 sampled patients that were physically restrained by staff (Patients #5 and #2).

The findings include:

Review of hospital policy entitled "Restraints, Seclusion, and Safety Devices" dated 06/28/2010 revealed, "POLICY:...5. THERAPEUTIC HOLD - The brief physical holding of a patient in a manner that restricts his/her movement for the purpose of calming or providing physical safety to the patient, other patients, staff members or others. A therapeutic hold is used only by individuals trained in therapeutic hold techniques, and only when less restrictive measures have been attempted and have been determined to be ineffective....PROCEDURES:....2. TRAINING: Hospital staff involved in meeting the patient's needs are educated upon hire before they participate in the use of seclusion/restraint and annually thereafter. Training can be completed via didactic class or online self-study with successful completion of a post-test and competency. Hospital staff includes personnel from the following areas: Nursing,...Training Requirements Include: a. The underlying causes of threatening behavior. b. Less restrictive alternative. c. Proper and safe application/removal...of restraints. d. Monitoring patient's physical/psychological status...."

1. Closed record review for Patient #5 revealed a 27 year-old male with a history of schizophrenia presented to the Emergency Department (ED) via Emergency Medical Services (EMS) on 04/17/2011 at 1638 with a complaint of not taking his medication. Record review revealed the patient was involuntarily committed by the physician. Review of RN #1's note at 1929 revealed, "Assumed patient care. Patient awake and alert, breathing even and unlabored. Patient stares at RN, nonverbal. No response to questions or requests. Patient is INVOL(untary)." Review of RN #1's note at 1951 revealed, "Patient more verbal at this time, answering questions. Patient requested water; provided. patient continues to refuse to change into gown." Review of RN #1's note at 2017 revealed, "Patient continued to refuse gown, now stating 'I want my momma. I'm not putting on no mother (expletive) gown'. Patient more active in room, pacing. Patient multiple trips back and forth to bathroom; not following directions of security or nurse. CPO (Company Police Officer) and security to bedside; patient medicated." Review of RN #1's note at 2110 revealed, "Patient pacing in hallway, appears to becoming more agitated. Refusing to stay in room, becoming aggressive with staff. (RN #2) from Psych ED aware of patients increasing agitation; will inform (Physician #2)." Review of RN #1's note at 2120 revealed, "Patient now states he is leaving, attempting to walk to double doors. When patient informed that he must stay in room he became very angry. States 'I need some water'. Patient then picks up water and proceeds to pour water on all staff member. Patient instructed to stop by CPO and water taken from patient. Patient then attempts to leave room and begins to push and punch staff. Patient instructed to stop, refused. At this time patient was restrained by CPO and security. This RN then left area to inform Psychiatrist of situation. Upon returning to Psych area security states that patient has stopped resisting. When patient was moved to stretcher he was noted to have agonal respirations. Patient moved to resus(citation) room at this time." Review of RN #1's note at 2125 revealed, "Patient was being bagged with BVM (bag-valve mask). Upon arrival to resus room patient was pulseless, asystole on monitor; CPR (cardiopulmonary resuscitation) started." Review of RN #1's note at 2217 revealed, "Resuscitation attempts unsuccessful; efforts stopped. TOD (time of death) 2211." Record review revealed patient's body was sent to the Office of the Chief Medical Examiner for autopsy. Review of the "Report of Autopsy Examination" dated 09/06/2011 and signed by a physician from the Medical Examiner's office revealed, "Date of Exam 04/18/2011....SUMMARY AND INTERPRETATION....Based on the history and investigative findings, it is my opinion that the cause of death in this case is asphyxia due to restraint."

Review on 10/18/2011 at 1130 and on 10/20/2011 at 1130 of video taped footage of the Psychiatric Area of the ED dated 04/17/2011 and beginning at 2113 revealed two different views were recorded. Review on 10/18/2011 with a staff member from the ED (to identify staff in footage) and legal department staff revealed the camera angle from down the hall that showed Room 65 on the right side of the hall. Review on 10/20/2011 with the Vice President of Nursing and legal department staff revealed the camera angle was from down the hall and looking directly into Room 65. Review of the footage revealed the patient was physically restrained from 21:15:26 (when CPOs begin to hold the patient by his arms and then go to the floor with the patient at 21:15:30) until 21:17:50 (when staff lift the patient off of the floor and place him on a stretcher). Further review of footage revealed the following events at the following times:
? 21:15:25 - RN #1 turns away from the patient's room and walks down the hall. The 2 CPOs are holding the patient's arms, one on each side. (No nurse in room as physical restraint is initiated by CPOs).
? 21:15:26 - Patient lifts up slightly and sits on bed (CPOs still beside of and with hands on the patient).
? 21:15:28 - RN #1 looks over shoulder then turns around and faces the patient's room. SO #1 and SO #2 head into room. CPO #1 leans down towards bed. CPO #2 not in view.
? 21:15:29 - RN #1 turns back away from and continues to walk away from room. Patient is visible standing and facing towards the right side of the room. CPO #1 goes behind the patient. CPO #1 lifts his right arm out with elbow bent and moves it towards the patient.
? 21:15:30 - CPO #1's arm not visible. CPO #1 is leaning forward or bending down. Patient not visible. SO #1 and SO #2 in doorway looking in. CPO #1 and patient go backwards (towards left side of room) together. CPO #2 comes into view with in front of patient with his arms extended, but hands not visible. RN #1 looks back towards room again, then turns and continues to walk away from room.
? 21:15:31 - Patient's right hand is in the doorway, holding onto the door jam. The 2 Security Officers are still in the doorway. Both CPOs face the doorway as they and the patient are going down.
Video footage review revealed the CPO and Security staff continued to physically restrain the patient on the floor with no nurse present to monitor the patient until 21:16:35, when RN #2 entered the room.

Personnel file review for RN #1 revealed the staff member was hired on 12/04/2000 and became a registered nurse during 2005 and remained employed at the hospital. File review revealed the nurse worked in the ED until 05/21/2011, at which time she moved and terminated employment. File review revealed no documentation the nurse received NCI (Nonviolent Crisis Intervention) training during her employment at the hospital.

Interview on 10/19/2011 at 1215 with the Service Line Director of Emergency Services revealed NCI (Nonviolent Crisis Intervention training) is required for all permanent ED staff within a year of hire. Interview revealed nurse should be present throughout a physical restraint. Interview revealed, "A tech can assist, at time security can assist, but we try not to use them. They follow the direction of nursing staff. The nurse should be clinically directing and overseeing that (the physical restraint). (The physically restrained patient) is monitored more often. A behavioral health emergency is the same as a medical emergency.

Interview on 10/19/2011 at 1510 with the Vice President of Nursing confirmed there was no documentation that RN #1 received NCI training during her employment at the hospital. Further interview with the Vice President on 10/20/2011 at 1130 with the Vice President of Nursing during video taped footage review of the physical restraint of Patient #5 on 04/17/2011 confirmed nursing staff was not continuously present and did not continuously supervise the restraint. Further interview confirmed nursing staff did not continuously monitor the patient to ensure safety during the physical restraint.



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2. Closed medical record review for patient #2 revealed a 42 year old male presenting to the hospital's Emergency Department (ED) via Emergency Medical Services on 04/24/2011 at 0203 involuntarily committed (IVC) for a psychiatric evaluation. Record review of Nurse # 5's notes dated 04/24/2011 at 0650 revealed "Late entry (not timed) PT became extreamly (extremely) agitated unable to verbally deescalate. PT pacing and shouting in room. Unable to obtain additional orders. Pt charged from room and begain (began) thoughing (throwing) his body against the doors tot he (of the) unit. With assistance of Security Guard # 3 and CPO (Campus Police Officer) # 2 PT was placed in a threaputic (therapeutic) hold and assited (assisted) to the floor. As to prevent harm to self." Record review revealed Security Guard #3 and CPO #2 assisted Nurse #5 in the therapeutic hold of patient #2.

Review of Hospital's Security Company's document titled "INCIDENT/INVESTIGATION REPORT" prepared by CPO #2 and dated 04/24/2011 revealed "On Sunday April 24th, 2011 at approximately 0500 hrs while in the psychiatric department patient in room 66 came combative to where he attempted to escape the psychiatric department through the double doors. Physical force had to be used to retain the patient. Further review of report revealed narrative continued stating "...(Patient #2) tried to leave through double doors...by hitting and kicking the doors... (CPO #2) along with (Security Officer #3), (Nurse #5), and (Security Officer #4) used soft hands on Mr.(Patient #2) so that lay him on to the floor so that we could better restrain the patient. Report review revealed Patient #2 was restrained on the floor by Nurse #5, Security Officers #3 and #4, and CPO #2.

Personnel file review for RN #5 revealed the staff was a contracted agency nurse that began work as a psychiatric nurse in the ED on 02/07/2011. File review revealed the nurse's contract expires on 11/26/2011. File review revealed no documentation the nurse received NCI training or other nonphysical intervention skill training during his employment at the hospital.

Interview on 10/19/2011 at 0950 with RN #5 revealed the nurse had not received NCI training or other nonphysical intervention skill training in many years. Interview revealed the nurse was aware NCI training was offered at the hospital, but he had not been required to take it.

Interview on 10/19/2011 at 1510 with the Vice President of Nursing confirmed there was no documentation that RN #5 received NCI training during his employment at the hospital.


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