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Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.13, PATIENT RIGHTS, was out of compliance.

A-202 The hospital must require appropriate staff to have education, training, and demonstrated knowledge based on the specific needs of the patient population in at least the following: The safe application and use of all types of restraint or seclusion used in the hospital, including training in how to recognize and respond to signs of physical and psychological distress (for example, positional asphyxia). Based on interviews and document reviews, the facility failed to ensure staff obtained an order for the use of physical restraints before initiation, and before a chemical restraint (medication used to manage the patient's behavior or restrict movement) was administered. Additionally, the facility failed to ensure the use of physical restraint occurred in accordance with facility policy. Furthermore, the facility failed to ensure staff recognized and responded to signs of physical distress in a restrained patient. This failure was identified in one of one medical records of patients who expired while restrained. (Patient #1)

Based on interviews and document reviews, the facility failed to ensure staff obtained an order for the use of physical restraints before initiation, and before a chemical restraint (medication used to manage the patient's behavior or restrict movement) was administered. Additionally, the facility failed to ensure the use of physical restraint occurred in accordance with facility policy. Furthermore, the facility failed to ensure staff recognized and responded to signs of physical distress in a restrained patient. This failure was identified in one of one medical records of patients who expired while restrained. (Patient #1)

Findings include:

Facility policies:

The Seclusion/Restraint policy read, restraint use will be limited to clinically-justified situations, and the least restrictive restraint will be used. The facility provides leadership and organizational accountability for monitoring the safety, appropriateness and necessity of restraint use. Patients are to be assessed by a nurse immediately after restraints are initiated to assure the safe application of the restraint. The nursing assessment will include evaluation of the patient for signs of injury associated with restraint use, as well as a circulation assessment of any restrained extremities and an evaluation of the patient's respiratory and cardiac status.

When a physician or other licensed practitioner, authorized by State law to order restraints, is not available to issue a restraint or seclusion order, an regstered nurse (RN) with demonstrated competence may initiate restraint. In these emergency situations, the order must be obtained during the emergency application or immediately (within minutes) after the restraint or seclusion is initiated.

The Physical Holding for Forced Medications section read, use of force to physically hold a patient to administer a medication against the patient ' s wishes is considered restraint. The patient has the right to be free from restraint and also has the right to refuse medication. Healthcare staff are expected to use the least restrictive method of administering the medication to avoid or reduce the use of force, when possible. Use of force in order to medicate a patient, as with other restraints, must have a physician's order prior to the application of the restraint (use of force).

Appendix A, Training Requirements read, staff will demonstrate competency in the application of restraints, implementation of seclusion, monitoring, assessment, and providing care for a patient in restraint or seclusion. Training will be provided to all staff designated as having direct patient care responsibilities (as listed by the facility), including contract or agency personnel. In addition, if hospital/ASC security guards or other non-healthcare staff (the facility to list) assist direct care staff, when requested, in the application of restraint or seclusion, the security guards, or other non-healthcare staff (as defined by the facility) are also expected to be trained and able to demonstrate competency in the safe application of restraint and seclusion.

Before applying restraints, monitoring, assessing, or providing care for a restrained patient, staff must first demonstrate the necessary knowledge and skills to do so safely. This competency should be confirmed during orientation and reviewed in accordance with the regulations. Staff will be trained and able to demonstrate competency and training to recognize and respond to signs of physical and psychological distress (e.g., positional asphyxia). Staff will be trained and able to demonstrate competency in monitoring the physical and psychological well-being of patients who are restrained. This training will include, but will not be limited to, respiratory and circulatory status, skin integrity, and vital signs.

Appendix D, Definitions read, a physical restraint is any manual method or device, such as material or equipment, attached to a patient that they cannot easily remove, and that restricts their freedom of movement or access to their own body. This includes any measure that immobilizes or limits the patient ' s ability to move their arms, legs, body, or head freely. The policy further defines a drug or medication, when used to manage the patient's behavior or restrict the patient's freedom of movement, and is not a standard treatment or dosage for the patient's condition, as a type of restraint. When medications are used as a restraint, it's important to understand that whether they are considered a restraint depends not on the treatment setting, but on the specific situation being addressed. A medication is considered a chemical restraint if it is not being used as a standard treatment for the patient's medical or psychiatric condition, or if it is used in a dosage outside the normal range, and its effect is to control the patient's behavior or restrict their freedom of movement.

The Use of Force policy defines Passive/Verbal Resistance as an event in which the subject verbally states their intention of non-compliance or engages in argumentative behavior. This includes being deliberately non-compliant with facility colleagues to ensure their safety and well-being. Colleagues should allow the Subject to de-escalate and calm down on their own. Provide space, back away, or place safe barriers between themselves and the Subject.

The policy further defines Active Resistance as the Subject using verbal threats or vulgarity, pulling away, or fleeing without attempting to cause injury to another. If the Subject is free to leave the facility voluntarily, colleagues should implement de-escalation techniques. Provide loud and clear verbal commands to the individual, indicating the action they should follow, and attempts to apprehend the individual will be avoided.

Active Physical Aggression is defined as a subject actively exhibiting physical violence towards other individuals in the moment. A continuum of force may be applied to defend oneself or another against imminent bodily harm or death. The level of force used depends upon the degree of the physical attack and the reasonable perception of the threat of injury. Colleagues should attempt to retreat and/or back away from the physical attack for their safety and continue using de-escalation techniques to prevent further escalation. Additionally, Colleagues should contact law enforcement officials to further manage the event. The policy further read that for Subjects who are pushing, slapping, biting, spitting, pinching, or throwing objects, empty-hand control techniques may be used. Use of force examples (for empty-hand control techniques) include empty-hand/pressure point escort, and clinical medication/behavioral restraints.

Colleagues who use any level of force in an incident will complete a Use of Force Report, accurately detailing the Subject's actions that necessitated force as well as the colleague's actions and all circumstances relevant to the event. The report should articulate the factors perceived and the reason the colleague believed the use of force was necessary under the circumstances.

1. The facility failed to ensure security staff did not initiate the use of manual holds, and bodily force (physical take-down and physical hold) to restrain patients. Nursing staff also failed to obtain a provider order before administering a chemical restraint. Additionally, security staff failed to use verbal de-escalation techniques on a patient who was not immediately posing a threat to self or others.

A. Document Review

i. Medical record review revealed on 11/28/24 at 2:49 p.m., Patient #1 was admitted with acute pancreatitis (inflammation of the pancreas).

On 11/29/24, Patient #1 developed progressive shock (a life-threatening condition where the internal organs begin to fail due to a lack of blood and oxygen) and was transferred to the Burn Intensive Care Unit (ICU). Further, medical record review revealed, on the evening of 12/5/24, Patient #1 developed severe agitation, acute progressive encephalopathy (a medical illness causing progressive brain dysfunction), and respiratory failure (the lungs cannot get enough oxygen into the blood). Additionally, Patient #1 removed their nasal feeding tube several times. Medical provider (Provider) #17 prescribed Haldol to be administered as needed and ordered the application of non-violent medical restraints (non-behavioral restraints used to restrict a patient's movement for medical reasons) on both of Patient #1 ' s wrists to prevent them from removing medical devices necessary to treat the patient's medical condition.

a. Review of the nursing documentation entered on 12/6/24 at 6:14 p.m. revealed Patient #1 became agitated, removed the non-violent restraints on both of their wrists, and disconnected all medical devices from their body. Patient #1 also removed their soiled disposable adult brief, took out feces, and smeared it on their body and the surrounding area. Afterward, Patient #1 ran out of their ICU room and through the emergency exit door into the parking lot.

Further nursing documentation review revealed at 4:34 p.m., while in the parking lot, Patient #1 experienced respiratory arrest (breathing completely stopped), and a code blue (emergency code for when a patient's heart stops beating) was called. The code blue lasted 48 minutes, and at 5:22 p.m., Patient #1 expired.

ii. A review of the Use of Force report completed by security officer (Officer) #3 on 12/6/24 at 10:41 p.m., revealed nursing staff had alerted security assistance was needed on the ICU, and both Officer #2 and Officer #3 responded to the alert. Upon their arrival, they were informed Patient #1 eloped and was in the adjacent parking lot. Both Officer #2 and Officer #3 went to the parking lot to assess the situation.

According to Officer #3's use of force report, once in the parking lot, they saw Patient #1 walking around unclothed and covered in feces. Officer #3 approached Patient #1, who then wiped feces on the officer. Officer #3 backed away from the patient, and as Officer #3 moved back, Patient #1 began to run. Officer #3 responded by using a one-arm takedown (a type of physical restraint used to force a person to the ground) to bring Patient #1 to the ground. Once Patient #1 was on the ground, Officer #2 approached and grabbed Patient #1's other arm. Together, both officers physically held Patient #1 face down on the ground while Patient #1 continued to struggle.

At 4:30 p.m., registered nurse (RN) #13 administered 5 milligrams (mg) of Haldol (a medication used to chemically restrain a patient and limit movement) intramuscularly to Patient #1 while Officers #2 and #3 physically held and restrained the patient. At 4:32 p.m., Patient #1 stopped breathing, did not have a pulse, and was cyanotic (blue around the face and chest from lack of oxygen). While in the parking lot, nursing staff started cardiopulmonary resuscitation (CPR).

Upon request, the facility was unable to provide evidence that a provider had ordered violent physical restraints or a chemical restraint for Patient #1.

Although Officers #2 and #3 submitted a use of force report, the facility was unable to provide evidence Patient #1 posed an imminent threat to themselves or others or that the patient's behavior warranted the use of physical restraint.

Additionally, the use of force reports completed by Officers #2 and #3 contrasted with the Use of Force policy. According to the Use of Force policy, the use of force may be applied to defend oneself or another against imminent bodily harm or death. Physical force should have only been used when necessary and only when patients attempted to harm themselves or others. Security officers should have retreated or backed away from patients who attempted to physically engage, and continued using de-escalation techniques to prevent the situation from further escalating.

Lastly, the officers' actions during the event resulted in unnecessary harm to Patient #1. According to Patient #1's autopsy report provided by the facility on 4/14/25, the use of physical force and the administration of Haldol when Patient #1 was physically restrained contributed to their death. Additionally, Patient #1 had blunt force injuries present on their head, bleeding within their eyes, and bruising across their chest, back, and abdomen, which were a direct result of excessive pressure being applied while Patient #1 was physically held face-down on the ground. This prevented Patient #1 from breathing and caused the patient to become unresponsive. Furthermore, the autopsy report stated, Patient #1's manner of death was homicide.

B. Interviews

i. During a discussion with facility leadership, on 4/15/25 at 5:01 p.m., chief medical officer (CMO) #16 stated they conducted a review of Patient #1's medical record. CMO #16 stated on 12/5/24 at 11:02 p.m., an order for Patient #1 to receive Haldol as needed (PRN) for agitation was entered by Provider #17. CMO #16 further stated Haldol was not administered to Patient #1 as a chemical restraint since the medication was administered to treat the agitation resulting from their encephalopathy.

CMO #16's interview was in contrast to the medication order for Haldol, which directed it to be given intravenously to treat agitation. However, Patient #1's medical record revealed that the Haldol was administered intramuscularly while the patient was physically restrained face down on the ground.

CMO #16's interview also contrasted with the Restraint/Seclusion policy, which stated medications were intended to enable, not disable patients. The administration of a medication to reduce the patient's ability to effectively or appropriately interact with the world around them was a restraint.

ii. On 4/9/25 at 2:11 p.m., RN #1 was interviewed and stated they were the primary nurse for Patient #1 on the day the patient eloped. RN #1 stated they informed Provider #17 of Patient #1's elopement. However, RN #1 further stated that they did not obtain a provider order to physically restrain Patietn #1 or to administer a chemical restraint to the patient.

RN #1's interview contrasted with the Restraint/Seclusion policy, which stated when a provider was not immediately available, an RN with demonstrated competency could initiate the use of physical restraint. However, an order for physical restraint should be obtained from a provider immediately (within minutes) after initiating the physical restraint.

iii. On 4/10/25 at 11:16 a.m., Officer #6 was interviewed and stated security officers attempted verbal de-escalation with patients who attempted to elope. Officer #6 stated this was the first step before any physical intervention. However, Officer #6 also stated security officers initiated manual holds, physically engaged patients, and used force to prevent elopement. Officer #6 further stated a physician's order was not needed when patients were physically restrained or when officers used force to take a patient to the ground.

Officer #6's interview contrasted with the facility's Restraint/Seclusion policy, which defined physically holding a patient to restrict movement against their will as a restraint and warned that physical holds posed a risk of patient death, including from complications such as positional asphyxia.

Additionally, the policy stated that to ensure the safety of the patient when physical and chemical restraints were initiated, only an RN who had been deemed competent was permitted to initiate the use of physical restraint before a provider order was obtained. Furthermore, a provider order for chemical restraint was required before staff physically held a patient down to administer a medication to the patient.

2. The facility failed to ensure that contracted security officers were deemed competent to apply restraints and in recognizing and responding to signs of physical and psychological distress in accordance with facility policies.

A. Document Review

i. A review of personnel records for Officer #2, Officer #3, and Officer #6 revealed no evidence that the security officers had been deemed competent to apply restraints and in recognizing and responding to the signs of physical distress in patients who were restrained.

This contrasted with the Restraint/Seclusion policy, which stated security officers will be trained and able to demonstrate competency in the safe application of all types of restraints used at the facility, including training to recognize and respond to signs of physical and psychological distress, such as positional asphyxia.

B. Interviews

i. On 4/10/25 at 11:16 a.m., Officer #6 was interviewed and stated that security officers were required to complete Crisis Prevention Institute (CPI) training, which focused on preventing, de-escalating, and managing hostile or escalated situations. Officer #6 stated they were given facility policies to review upon hire and had not been required to complete facility-specific training or competencies during their four years of employment, as they were contracted staff.

ii. On 4/10/25 12:18 p.m., an interview was conducted with director of security (Director) #10. Director #10 stated that since security was contracted, the security company followed its own policies and did not use facility-specific training or procedures.

Upon request, the was unable to provide evidence security officers had been educated, trained, and deemed competent in the application of restraints or in recognizing and responding to signs of positional asphyxia when physical force was used as a restraint. Additionally, the facility was unable to provide evidence of preventative measures implemented after use of force by security officers resulted in Patient #1's death.

Despite the findings in Patient #1's autopsy report, which indicated the use of physical force as a form of restraint, along with the administration of Haldol while the patient was physically restrained contributed to Patient #1's death, the facility was unable to provide evidence it had implemented measures to mitigate risk or prevent a similar event from occurring in the future. This lack of follow-up conflicted with the Restraint/Seclusion policy, which required the review of restraint-related events, the implementation of preventive measures, and organizational accountability to ensure that restraints were used only when clinically justified and in the least restrictive manner.