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Based on document review and interview, it was determined that the Hospital failed to protect and promote patient's rights by ensuring that appropriate use of physical hold was in accordance with the crisis prevention intervention (CPI) technique and application of restraints. This potentially places any patient requiring CPI intervention and use of restraints at risk for harm, serious injury, or death. As a result, the Condition of Participation 42 CFR 482.13, Patient Rights, was not in compliance.

Findings include:

1. The Hospital failed to ensure that the physical hold/crisis prevention intervention used was in accordance with safe and appropriate restraint techniques. See deficiency at A-167.

The Immediate Jeopardy (IJ) began on 11/9/2021 due to the Hospital's failure to ensure that the use of physical hold was implemented in accordance to the crisis preventive intervention technique while placing the patient in restraints. Immediately following the improper use of physical hold during application of restraints, the patient went into cardiac arrest and subsequently died while in the Hospital.

The IJ was identified on 12/10/2021 at 42 CFR 482.13, Patient Rights, and was announced on 12/10/2021 at 11:30 AM, during a meeting with the President of the Hospital, Chief Operating Officer, Chief Nursing Officer, Chief Medical Officer, Regulatory Officer, Assistant Chief Nursing Officer, and the Executive Director of Quality and Regulatory. The IJ was not removed by the survey exit date of 12/10/2021.

Based on document review and interview, it was determined that for 2 of 2 patients' (Pt. #7 and Pt. #8) clinical records reviewed regarding use of restraints for non-violent behaviors, the Hospital failed to ensure that the care plan was modified.

Findings include:

1. On 12/7/2021, the Hospital's policy titled, "Protective and Restraint Policy - Violent and Non-Violent" (reviewed by the Hospital on 10/14/2020) was reviewed and included, "... VI. Procedure for Acute Medical and Post Surgical Care (Non-Violent)... 8. Documentation regarding restraints includes the following... b. Revisions to the plan of care..."

2. On 12/7/2021 at approximately 12:30 PM, the clinical record of Pt. #7 was reviewed. Pt. #7 was admitted to the Hospital on 12/3/2021 with diagnoses of hypoxia (low oxygen) and fluid overload. The clinical record indicated that Pt. #7 was in soft wrist restraints on 12/6/2021 and 12/7/2021. The use of restraints was not documented in the patient's plan of care.

3. On 12/7/2021 at approximately 12:45 PM, the clinical record of Pt. #8 was reviewed. Pt. #8 was admitted to the Hospital on 11/25/2021 with a diagnosis of respiratory failure. The clinical record indicated that Pt. #8 was in soft wrist restraints from 12/4/2021 through 12/7/2021. The use of restraints was not documented in the patient's plan of care.

4. On 12/8/2021 at approximately 2:28 PM, an interview was conducted with E #10 (Nurse Educator). E #10 stated that the patient's plan of care should be modified to reflect the use of restraints.

Based on document review, observation, and interview, it was determined that for 1 of 1 (Pt #1) clinical record reviewed for a patient in a physical hold, the Hospital failed to ensure that the physical hold/crisis prevention intervention used was in accordance with safe and appropriate restraint techniques.

Findings include:

1. On 12/7/2021, the Hospital's policy titled, "Protective and Restraint Policy-Violent and Non-Violent" (revised 10/14/2020) was reviewed and required, " ... H. Training ... 1. Clinical caregivers involved in ... applying or assessing patients in restraints will be trained according to their responsibilities regarding restraint at orientation and before being asked to perform these duties ... Safe application and use of restraint devices and quick release techniques ... Identifying signs of physical and psychological distress including positional hypoxia or circulatory impairment."

2. On 12/8/2021, the Hospital's "CPI - crisis prevention intervention" manual, dated 2020, was reviewed and indicated, " ... Restraint -Related Deaths- ...External respiratory restriction as a result of the restraint position: Positional asphyxia (a form of asphyxia [deprived of oxygen may result in death] which occurs when someone's position prevents the person from breathing adequately ..." ...Understanding the Risks of Physical Restraints ... Best Practice Indicators ... Only staff who have received training should use restrictive intervention skills ... Staff using restrictive interventions must be fully aware of the risk associated with each intervention ... used only for the minimum amount of time, using the minimum amount of restriction ... Warning Signs and Corrective Actions ... Voids bladder ... Treat as URGENT. Immediately assess level of restriction and check to ensure you are not impeding or restricting breathing ... Consider letting go as soon as possible ..."

3. On 12/8/2021, the PSO (Patient Safety Officer) job description (dated 1/2020) was reviewed and required, " ...Minimum Qualifications ...Competency Requirements ...required to pass initial and annual competency evaluations consisting of the following ... De-escalation ... Clinical Restraint Usage ... Additional Training Requirements: Must successfully complete the following ... Crisis Prevention Institute (CPI) Nonviolent Intervention ..."

4. On 12/7/2021, the clinical record of Pt. #1 was reviewed. Pt. #1 presented to the Emergency Department on 11/9/21 at 11:42 AM and was admitted to the SICU (surgical intensive care unit) on 11/9/2021 at 6:30 PM. The clinical record included:

-The triage nurse assessment note by E #5 (ED Charge Nurse) on 11/9/21 at 12:08 PM, included, "Received (Pt.#1) via CPD (Chicago Police Department) with (home care nurse/Z #1). Pt (Pt. #1) is agitated and aggressive. Security at bedside."

-The ED nursing note 11/9/2021 at 12:25 PM, " ... (Pt.#1) jumped out of cart ... unable to redirect ... Attempting to medicate ... Security (E#1) knocked to floor ... Leather restraints applied."

- The medication administration record indicated that Pt.#1 was given Haldol (antipsychotic) 5 mg (milligrams) injection and Lorazepam (sedative) 2 mg injection intramuscularly through Pt. #1's right thigh on 11/9/2021 at 12:26 PM.

-The ED nursing note on 11/9/2021 at 12:34 PM, "(Pt. #1) turned blue and stopped breathing. Code blue called (medical emergency) ..."

-The clinical record indicated that on 11/9/2021 at 12:35 PM, Pt. #1 had asystole (absence of pulse/heart rhythm). A chest tube was inserted to Pt. #1's right chest because of diminished lung sounds. Follow-up CT (Computerized tomography) scan on 11/9/2021 indicated that Pt. #1 had a pneumothorax (presence of air between the lungs causing lung collapse). Pt. #1 was transferred to the Hospital's intensive care unit on 11/9/2021 until 11/25/2021. On 11/25/2021, Pt. #1 died at 11:55 PM.

- The clinical record indicated that Pt. #1 had no history of diabetes or hypertension. Pt. #1's clinical record also included that per the patient's mother, Pt. #1 did not have fever, nausea, vomiting, diarrhea, or complaints of any pain prior to admission.

5. On 12/8/2021, the Hospital's incident report on 11/9/2021 written by E #2 (Patient Safety Officer/PSO Manager) was reviewed and included," ...On 11/9/2021 security was requested to respond to (ED Room #18) for a (psychiatric) patient (Pt. #1) ... At that time (the Hospital's PSOs) (E#1, #3, #4, #7, #8, and #9) also responded ... (Pt. #1) was calm at that time so (E#3 and E #4) and myself (E#2) left to handle another situation ... Within five minutes, (E#1) requested emergency assistance back in the room ... As I (E #2) entered the room (Pt. #1) was yelling at the (Z #1) who was attempting to calm him down ... E#3, and E#4 arrived at the same time. (Pt. #1) then pinned (Z #1) against the wall and started screaming at her. I (E #2) grabbed him from behind under (Pt. #1's) arms to pull him off (Z #1), and was assisted by the rest of security staff ... (Pt. #1) was able to spin around and elbow me in the mouth, and grab (E#3) by the hair ... We were able to lift him up off the ground, so (Pt. #1) did not have good footing and laid (Pt. #1) down on the bed. I (E #2) was controlling (Pt. #1's) legs while (E#8) put the restraints on. (Pt. #1) was able to break one restraint ... (E#4) was lying across (Pt. #1's) pelvic area to control (Pt. #1's) body. (E#7) and (E#3) were securing one arm while (E#8) and (E#9) were securing the other. As we were finishing, (E#4) stated she believed she was being urinated on (by Pt. #1). When we stood up (E #4) was covered in urine from her chest down to her knees. The staff immediately noticed (Pt. #1) was unconscious and we assisted in taking the restraints off. The clinical staff then started CPR (cardiopulmonary resuscitation) ..."

6. On 12/9/2021, the personnel files of six PSOs involved in the incident were reviewed. At the time of the incident, 2 ( E #3 and E #7) of 6 PSO officers did not have a current CPI training.

7. On 12/8/2021 at 9:56 AM and on 12/10/2021 at 9:00 AM, interviews were conducted with the Manager of Public Safety (E#2). E#2 stated, " ...There were 6 security officers and nursing staff assisting with the restraint, (Pt. #1) was a pretty strong guy ... While we were restraining (Pt. #1) continued to fight. (E#4) was holding down in the pelvic area, (E #4) said out loud that she felt like she was being peed on. When we stepped back, we saw that (Pt.#1) had peed and was not breathing." On 12/10/2021 at 9:00 AM, E#2 stated that when he (E #2) turned to look in the direction of E#4, he (E #2) could not see (Pt.#1) peeing because view was blocked by E#4. E #2 described that E#4 was laying over (Pt.#1's) pelvic area but saw the urine trickling down to floor. E#2 was asked to demonstrate the area where E#4 was positioned, E#2 pointed on his body from sternum to pelvic area. E#2 stated that E#4 is approximately 5'6" and weighs 230-250 pounds, and that E #4's head was perpendicular to Pt.#1. At the time, E#2 stated that Pt.#1 continued to fight so extra weight was used to restrain from movement.

8. On 12/8/2021 at 11:34 AM, an interview was conducted with a PSO (E#3). E#3 stated, " ...We tried to hold him back and (Pt. #1) grabbed my neck, and (E#2) was able to get his arms under pt's armpits and we were able to get him on bed with a slight lift and swing motion ... As we held the patient to prevent kicking and thrashing, restraints were being applied. I was holding down left shoulder and someone else on right, (E#4) was over the pelvic area because he kept kicking, others were holding the legs, but he was still kicking. It took about five minutes of holding down to apply the restraints, then everyone let go of patient, about 1-2 minutes the ED staff noticed he was not breathing and started doing CPR." On 12/8/2021 at 12:25 PM, an interview was conducted with a PSO (E#4). E#4 stated, " ... We were called back to ED because (Pt.#1) had the home care nurse (Z #1) around the neck. We all responded, we had to pick the patient off the (home care nurse) and put him on the bed. All security officers took an arm, and a leg, I was across the lower part of the body by the thighs. I got peed from my chest down to my knees, while holding the patient and after the restraints were applied I left the room and had to go home to change..."

9. On 12/8/2021 at 2:45 PM, an interview was conducted with the Director of Behavioral Health/Hospital CPI Educator/E#12. E#12 stated, "If staff must restrict movement to lower body, staff should never lean over pelvic area with body because we need to be able to observe the patient and prevent harm or injury. Staff should use arms across the knees, never put weight on patient, use arms across legs/knees to hold down patient. Urinating could be a sign of distress or trauma, and staff should immediately stop the restricting and assess the patient."

Based on document review and interview, it was determined that for 2 of 3 patients' (Pt. #1 and Pt. #8) clinical records reviewed regarding use of restraints for non-violent behavior, the Hospital failed to ensure that renewal orders were obtained, as required.

Findings include:

1. On 12/7/2021, the Hospital's policy titled, "Protective and Restraint Policy - Violent and Non-Violent" (reviewed by the Hospital on 10/2020) was reviewed and included, "... VI. Procedure for Acute Medical and Post Surgical Care (non-violent)... 7. Renewing restraint orders... c. A physician order is needed every calendar day for continuation of restraints..."

2. On 12/7/2021, at approximately 12:00 PM, the clinical record of Pt. #1 was reviewed. Pt. #1 was brought to the Hospital on 11/9/2021 due to aggression. The clinical record indicated that Pt. #1 was in soft wrist restraints for non-violent behaviors from 11/9/2021 through 11/15/2021. The clinical record lacked renewal orders while Pt. #1 was in restraints on 11/11/2021, 11/13/2021, and 11/14/2021.

3. On 12/7/2021 at approximately 12:45 PM, the clinical record of Pt. #8 was reviewed. Pt. #8 was admitted to the Hospital on 11/25/2021 with a diagnosis of respiratory failure. The clinical record indicated that Pt. #8 was in soft wrist restraints from 12/4/2021 through 12/7/2021. The clinical record lacked renewal orders while Pt. #8 was in restraints on 12/4/2021, 12/5/2021, and 12/6/2021.

3. On 12/7/2021 at approximately 12:45 PM, findings were discussed with E #6 (SICU/Surgical Intensive Care Unit Manager). E #6 stated that a renewal orders should have been obtained daily while patients are in soft wrist restraints..

Based on document review and interview, it was determined that for 2 of 4 patients' (Pt. #1 and Pt. #10) clinical records reviewed regarding use of restraints for violent and non-violent behaviors, the Hospital failed to ensure that patients were monitored while in restraints, as required.

Findings include:

1. On 12/9/2021, the Hospital's policy titled "Protective and Restraint Policy-Violent and Non-Violent" (reviewed by Hospital 10/14/2020) was reviewed and required, " ...V. Procedure for Violent or Self-Destructive Behavior (Violent)... F. Monitoring: 1. The following elements are monitored... every 15 minutes by a trained caregiver... 2. Psychological assessment... VI. Procedure for Acute Medical and Post-Surgical Care (non-violent).. 9. ...the following elements are monitored every 2 hours by trained clinical caregivers ... level of cognition ... level of agitation ... combativeness ...physical well-being ... vital signs ..."

2. On 12/7/2021, the clinical record of Pt. #1 was reviewed. Pt. #1 was brought to the Hospital on 11/9/2021 due to aggression. The clinical record indicated that Pt. #1 was in soft wrist restraints for non-violent behaviors from 11/9/2021 through 11/15/2021. The clinical record lacked documentation to indicate that Pt.#1 was monitored every 2 hours on the following dates: 11/11/2021 between 10:00 PM to 11/12/2021 2:00 AM (a total 4 hours), 11/14/2021 at 6:00 AM to 11/14/2021 at 9:00 AM (a total of 3 hours).

3. On 12/8/2021, the clinical record of Pt. #10 was reviewed. Pt. #10 was brought to the Hospital's ED (emergency department) on 12/3/2021 due to alcohol intoxication. The clinical record indicated that Pt. #10 was in restraints due to violent behaviors on 12/3/2021 from 6:15 PM through 10:15 PM. The clinical record lacked the required every-15 minutes monitoring from 6:45 PM through 10:00 PM (three hours and 15 minutes).

4. On 12/8/2021 between 2:20 PM and 3:00 PM, findings were discussed with E #10 (Nurse educator) and E #13 (ED Manager). E #10 stated that patients should be monitored every two hours while in soft wrist restraints. E #13 could not provide documentation regarding the required every-15 minutes monitoring for Pt. #10. E #13 said, "They drop the ball on that one."

Based on document review and interview, it was determined that for 2 of 2 patients' (Pt. #9 and Pt. #10) clinical records reviewed regarding use of restraints for violent behaviors, the Hospital failed to ensure that the required elements of the face-to-face evaluation within 1 hour after the initiation of restraints were documented.

Findings include:

1. On 12/7/2021, the Hospital's policy titled, "Protective and Restraints Policy - Violent and Non-Violent" (reviewed by the Hospital on 10/2020) was reviewed and required, "... V. Procedure for Violent or Self-Destructive Behavior (Violent)... D. Renewing Restraint Orders... 3. Every episode requires a LIP (licensed independent practitioner) to complete a one hour face to face. E. Documentation regarding restraint includes the following... 5. The patient's response to the intervention(s) used. 6. Rationale for continued use of intervention..."

2. On 12/8/2021, the clinical record of Pt. #9 was reviewed. Pt. #9 was brought to the Hospital's ED on 12/5/2021 due to alcohol intoxication. The clinical record indicated that Pt. #9 was in restraints due to violent behaviors on 12/5/2021 from 3:16 PM through 6:30 PM. The clinical record indicated that a face to face assessment was conducted at 3:07 PM (nine minutes prior to patient being placed in restraints). The clinical record lacked documentation of the required elements of the face to face evaluation within 1 hour after initiation of restraints.

3. On 12/8/2021, the clinical record of Pt. #10 was reviewed. Pt. #10 was brought to the Hospital's ED on 12/3/2021 due to alcohol intoxication. The clinical record indicated that Pt. #10 was in restraints due to violent behaviors on 12/3/2021 from 6:15 PM through 10:15 PM. The clinical record lacked documentation of the required elements of the face to face evaluation within 1 hour after the initiation of restraints.

4. On 12/9/2021 at approximately 2:50 PM, findings were discussed with E #13 (ED Manager). E #13 could not provide documentation regarding the required elements of the face to face evaluation within 1 hour after the initiation of restraints for Pt. #9 and Pt. #10.