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

A0145- The patient has the right to be free from all forms of abuse or harassment. Based on observations, document review and interviews, the facility failed to ensure patients were free from all forms of abuse and harassment. Specifically, the facility failed to have a program or process in place to ensure patients were not injured, intimidated, or unnecessarily restrained by utilizing a dog trained by the Police K9 Association to intimidate and restrain patients in three of three medical records reviewed of patients with behavioral or mental health concerns (Patients #1, #2 and #3).

A0168- The use of restraint or seclusion must be in accordance with the order of a physician or other licensed practitioner who is responsible for the care of the patient and authorized to order restraint or seclusion by hospital policy in accordance with State law. Based on interviews and record review, the facility failed to ensure all instances of restraints were in accordance with a physician or other licensed practitioner in two of two medical records reviewed where a K9 (dog) participated, either from barking or with direct physical contact, in intimidating and restraining patients (Patients #1 and #2).

Based on observations, document review and interviews, the facility failed to ensure patients were free from all forms of abuse and harassment. Specifically, the facility failed to have a program or process in place to ensure patients were not injured, intimidated, or unnecessarily restrained by utilizing a dog trained by the Police K9 Association to intimidate and restrain patients in three of three medical records reviewed of patients with behavioral or mental health concerns (Patients #1, #2 and #3).

Findings include:

Facility policy:

According to the facility policy Restraints/Seclusion, the facility philosophy supports the limited and safe use of restraints/seclusion in all clinical settings through the development and promotion of preventative strategies and the safe and effective use of alternatives that prevent injury to patients and others. A restraint is defined as any method (chemical or physical) of restricting an individual's freedom of movement, including seclusion, physical activity, or normal access to his or her body that is not a usual or customary part of a medical diagnostic or treatment procedure to which the individual or his or her legal representative has consented, and is not indicated to treat the individual's medical condition or symptoms, or does not promote the individual's independent functioning. Restraint use is defined by intent, rather than diagnosis or the type of restraining device or mechanism employed, and is specific to the patient's behavior. Restraint use is not to be used as a means of coercion, punishment, staff convenience, discipline, staff retaliation or to prevent unauthorized departure.

Restraint use within the facility is limited to situations with adequate and appropriate clinical justification based on a current individual assessment and only after the least restrictive interventions and alternatives have been considered and are deemed ineffective.

References:

According to the Security Department K9 Program Operations Manual, a canine (K9 or dog) is a facility-owned dog certified in obedience, agility, apprehension, handler protection, and scent discrimination. Dogs are trained as an intermediate level of force, generally used as a defense to protect a K9 officer or another individual from a verbal or physically escalated patient.

According to the National Police Canine Association Membership Book 2022-2023, the National Police Canine Association is a non-profit association dedicated to the training, development, and certification of law enforcement canine teams and their administrations.

1. The facility failed to ensure patients were free from abuse, restraint and harassment from K9s used in workplace violence prevention measures.

a. On 1/24/23 at 12:30 p.m., observations of the door to the facility's entrance revealed a sticker just above the door handle. The sticker read K9 security on premises. There was no other information regarding where in the facility or in what manner the K9s would be used.

i. On 1/24/23 at 2:19 p.m., observations in the facility's emergency department (ED) revealed a K9 accompanied by a K9 officer. The K9 was wearing a patrol harness (a harness that allowed the attachment of packs, pouches, and badges) and a muzzle. The muzzle was made of heavy leather straps and lined with steel.

b. Per interviews the K9 was used as a form of restraint and/or physical control when a verbally or physically escalated patient threatened staff members.

i. On 1/24/23 at 2:19 p.m., an interview was conducted with K9 officer (Officer) #1. Officer #1 stated the main job of the K9 was to provide staff protection, and that she and the K9 were trained through the National Police Canine Association. Officer #1 explained the K9 interacted with patients primarily by patrolling in the ED and other areas of the facility. However, if a patient became verbally or physically threatening, she would order the K9 to perform command presence. Officer #1 defined command presence as the K9 barking and growling near the patient with the intention of startling the patient into stopping the threatening behavior.

Officer #1 further explained if the patient continued to display threatening behavior, she would order the K9 to employ de-escalation. Officer #1 defined de-escalation as a technique in which the K9, while continuing to growl and bark, would jump on top of or placed its paws on a patient while attempting to bite. Officer #1 stated while the muzzle was never removed from the K9 as that would have been considered lethal force, when the K9 attempted to bite this caused the steel-lined muzzle to strike the patient. Additionally, Officer #1 stated during de-escalation the K9 would stand on the patient's chest, which had the potential to have caused injuries from the K9's claws.

Officer #1 explained command presence and de-escalation were used by the K9 handlers to assist other security officers restrain and/or de-escalate the patient's behavior, with the ultimate goal of preventing workplace violence. Officer #1 said these techniques were used on aggressive patients who had been intoxicated on drugs or alcohol, and that the K9 would not have been appropriate in a case in which the patient was threatening because of a medical reason such as dementia.

Officer #1 said she and the K9 responded to security alerts throughout the facility. She explained during security incidents she and the K9 primarily stood and observed the situation, while gathering information from the clinical team and other security officers on the scene. Officer #1 further explained the presence of the K9 was frequently enough to stop the patient's threatening behavior. Officer #1 said that although there was a discussion between the clinical and security teams as to the appropriate use of the K9, ultimately the decision to deploy (use command presence or de-escalation) was up to the handler.

ii. On 1/24/23 at 3:01 p.m., an interview was conducted with emergency department technician (Tech) #2. Tech #2 stated the K9 was used for patients who became physically disruptive. She explained if the security team became overwhelmed by an aggressive patient they would have deployed the K9. Tech #2 explained deployment included the dog "tackling" the patient, which caused the dog's claws to dig into the patient's chest, causing injury. The clinical team in the emergency department (ED) would then assess the patient and provide care for any injuries caused by the deployment or the K9. Tech #2 stated if the dog was deployed, it should have been documented in the patient's medical record, including any injuries sustained by the patient.

Tech #1 explained the K9s were used throughout the hospital, but should not have been used on patients with dementia or suicidal ideation (the desire to commit suicide). She further explained prior to K9 deployment, de-escalation techniques, including verbal de-escalation from a member of the social work team, should have been attempted. Tech #1 stated the K9 handler made the decision to deploy the K9, and would loudly announce when it was about to happen.

iii. On 1/24/23 at 3:21 p.m., an interview was conducted with registered nurse (RN) #3. RN #3 stated K9 security was used as an additional safety layer for staff on aggressive patients who needed physical restraint. She explained a K9 should not have been used on children, the elderly, or patients with a head injury. RN #3 stated that a physician and RN helped assess the security situation, but ultimately the decision to deploy the dog was with the handler. RN #3 said patient safety was assured as the K9 was deployed only in the muzzle. She further stated only the handler could command the K9, and all other staff would step away. She said any physical injury to the patient that resulted from deployment would then be assessed and treated in the ED.

c. A review of Patient #1's medical record revealed police brought her to the facility's ED on 12/29/22 at 6:31 p.m. She was assessed for altered mental status after she was found walking in the snow in socks and a dress. Patient #1 was placed on an M1 hold (an involuntary psychiatric/behavioral hold used to prevent an individual from leaving a facility when they were in imminent danger of harming themselves or someone else) by police prior to arriving at the ED.

According to RN documentation Patient #1 was able to obey commands but was timid, crying, hiding behind blankets, and displaying odd behaviors such as kissing the walls of the room. A security alert was called for Patient #1 after she made multiple attempts to leave her room. Per RN documentation, seven security guards and the K9 were in the room.

Per Physician #5's documentation, Patient #1 presented as gravely disabled and anxious due to a psychotic disorder. Patient #1 was appropriate during her interactions with the physician. He wrote Patient #1 was easily re-directable and although she initially refused to take oral medication for the treatment of psychosis, she was not verbally or physically threatening to herself or others so he felt he did not have the legal right to restrain her. After Physician #5 completed his initial interview, Patient #1 suddenly rushed to the door in an attempt to leave and was restrained by multiple security guards. Physician #5 wrote that he did not witness and was not informed of any attempts by Patient #1 to harm staff.

Physician #5 wrote that social worker (SW) #4 was able to verbally de-escalate Patient #1, after which Patient #1 agreed to take two oral doses of an antipsychotic medication. Patient #1 then again attempted to leave the room. Physician #5 documented he returned to her room to see Patient #1 being held down by six to seven security guards, while the K9 was in the corner of the room loudly barking. Physician #5 assessed Patient #1 as extremely anxious, and that the K9 barking was the primary driver to the patient's escalated behavior and anxiety. Physician #5 wrote he had further concerns that the barking impeded communication between the care team and the security team.

Physician #5 documented he asked the handler to remove the K9 from the room, but the handler refused, as it was her intention to keep the other security officers safe. Physician #5 wrote security officers placed Patient #1 in restraints, without a physician's order. The physician's note further stated once security stepped out of the room, the physician noted the patient to be laying calmly in bed, not fighting the restraints, with stable vital signs and no evidence of agitation.

Social worker (SW) #4 documented in Patient #1's medical record that she displayed symptoms of psychosis and that she was verbally re-directable. SW #4 further wrote Patient #1 became aggressive in her attempts to leave as seven security guards attempted to restrain her. SW #4 documented the presence of the K9 and the loud barking caused Patient #1 to become more escalated, as well as causing "chaos" and hindering communication. SW #4 further documented the handler refused the physician's request to remove the K9 from the situation.

i. On 1/26/2023 at 10:02 a.m., an interview was conducted with Physician #5. Physician #5 stated during her ED admission Patient #1 did not fully understand where she was or the implications of the situation around her. He stated as Patient #1 did not present as a threat to herself or staff she did not meet the legal criteria for chemical restraint, and that SW #4 had already successfully verbally de-escalated her prior to the use of the K9.

Physician #5 stated he had requested the handler remove the K9 from Patient #1's room as he was concerned the K9 was causing her psychological harm. Physician #5 further stated as it became clear the handler was not going to remove the K9, he allowed the patient to be restrained so the security officers and the K9 would leave the patient's room. Physician #5 explained although he was unsure the patient required restraint, after the security situation was resolved the medications the patient had agreed to take started working which then allowed the restraints to be removed.

ii. On 1/25/2023 at 4:51 p.m., an interview was conducted with SW #4. SW #4 stated he did not fear for his safety when he was with Patient #1 and did not feel restraints were medically indicated. SW #4 stated the handler determined when to deploy the K9, but that it was the physician's responsibility to order restraints. He said Patient #1 had experienced a violent sexual offense. SW #4 further stated the use of forcible restraint risked causing Patient #1 psychological trauma and retraumatization related to the sexual offense.

SW #4 expressed concern that mental health patients seeking care in the ED were confused, and a barking K9 could trigger a distress response in the patient as they felt loss of control and autonomy. He further expressed concern if a patient experienced psychological trauma from an interaction with a K9 they would not return to the ED for care in the future. SW #4 stated lack of emergency care could lead to an increase in psychotic symptoms and a worsening of a mental health crisis. SW #4 further stated this placed the patient at risk of misinterpreting reality, which could lead to physical harm towards themselves or others.

d. A review of Patient #2's medical record revealed police brought her to the ED on 12/23/22 at 11:18 p.m. due to disruptive behavior and intoxication. Per nursing documentation, Patient #2 was crying, upset, and attempting to use the staff computer in her ED room. An RN then documented the patient was becoming physically and verbally disruptive while displaying suicidal ideation. On 12/24/23 at 12:20 a.m., a verbal order for locking limb restraints was obtained from physician assistant (PA) #11.

On 12/24/22 at 1:58 a.m., SW #4 documented Patient #2 arrived at the ED in handcuffs, but these were removed without incident. He further documented Patient #2 was crying and upset, causing her to become verbally aggressive. SW #4 wrote Patient #2 initially did not make threatening remarks, did not become physically aggressive, and did not attempt to leave the facility. SW #4 wrote Patient #2 became agitated due to the presence of security and the K9, which led security to hold her down. The K9 was deployed and was standing on Patient #2's chest while barking. SW #4 further wrote Patient #2 became physically aggressive only after security displayed physical aggression towards her. He documented that prior to this incident, Patient #2 was emotionally labile (emotions were changing and altering easily) but she was redirectable and responsive while speaking with him.

A physician's note documented Patient #2 was initially cooperative, but became physically violent towards herself and staff. The physician wrote Patient #2's escalated behavior necessitated injection of medication into the muscle for chemical restraint, and so Haldol (a drug to reduce psychosis) and Versed (a drug to reduce anxiety and cause sleepiness) were prescribed. The physician further wrote after the administration of the drugs Patient #2 fell asleep. When she awoke, medical staff assessed her as no longer at risk for harm to herself or others and no longer intoxicated. Patient #2 was then discharged home.

i. On 1/25/2023 at 4:51 p.m., an interview was conducted with SW #4. SW #4 stated a physician had initially deemed Patient #2 too intoxicated to safely leave the ED. He further stated Patient #2 was not violent or aggressive and that he was able to verbally de-escalate her, with the goal of preventing restraints. SW #4 stated the patient initially refused to voluntarily take oral medications, which was why restraints were ordered. SW #4 said it was not his assessment that Patient #2 presented to the ED with an active psychiatric concern. He explained as security guards held down Patient #2's upper body so the medication could be administered, she began kicking with her legs. SW #4 further explained the handler then deployed the barking K9 onto the patient's chest while the handler stood by the K9. SW #4 said after the medication was administered to Patient #2 he left the room due to the uncontrolled atmosphere.

ii. On 1/25/2023 at 10:43 a.m., an interview was conducted with social worker supervisor (Supervisor) #6, during which she discussed Patient #2's admission to the ED. Supervisor #6 stated the social work team felt Patient #2 required a physical exam, time for the alcohol to leave her system to allow for safe self-care, and then access to a ride home. Supervisor #6 stated the patient became verbally aggressive, which then led to the security team restraining her with the K9 deployed on top of her. Supervisor #6 expressed concern that this further traumatized the patient who was already experiencing having her rights taken away as she was being restrained.

Supervisor #6 explained in patients with psychosis, dementia, or under the influence of drugs or alcohol, interventions to reduce violence other than the use of a K9 may have been more appropriate. She further explained K9 interventions decreased the social work team's ability to build rapport with patients, in particular as the K9 team did not always give patients time to experience the effects of medications. Supervisor #6 said using force or restraint decreased the patient's trust and the effectiveness of the less invasive interventions such as providing simple comfort, such as offering a cup of coffee.

Supervisor #6 stated the barking K9 made it difficult to provide care to patients. She further stated the facility needed a procedure to ensure the K9 did not further escalate patients. Supervisor #6 explained the physician had ultimate responsibility for the care of the patient, and the K9 should have been removed from Patient #1's room at the request of the clinical team.

Supervisor #6 said adverse psychological effects of a K9 used as command presence or deployed on a patient could have included significant traumatic harm or increased trauma for an already traumatized patient. She further said if patients presented to the ED, they had likely already experienced the worst day of their lives and that it was the function of the ED care team to lessen the risk of trauma rather than add to it. Supervisor #6 said if the presence of a K9 in the facility deterred patients from seeking care, they would experience worsened medical conditions and deterioration in psychological status as they would not have access to referrals for behavioral health.

e. Review of Patient #3's medical record revealed the 82 year old patient presented to the emergency department on 12/22/22 for treatment for aggressive behavior. According to the ED Provider Notes, Patient #3 had a history of rapidly progressing dementia with hallucinations, behavioral disturbances, and an inability to fully care for self at home. A Nursing Clinical Note from 12/23/22 at 3:49 p.m. documented the patient became verbally aggressive with staff, attempted to leave the ED, and threw a walker. The note continued by documenting the nurse attempted to redirect the patient unsuccessfully, and security, a K9, and two RNs were at the bedside to medicate the patient. There was no further documentation showing what the K9's involvement was with Patient #3.

This was in contrast with K9 Officer #1's interview where she stated the K9 would not be appropriate in cases where the patient was threatening because of a medical reason such as dementia. This was also in contrast with social worker supervisor (Supervisor) #6's interview who explained in patients with psychosis, dementia, or under the influence of drugs or alcohol, interventions to reduce violence other than the use of a K9 may have been more appropriate.

f. The facility was unable to provide evidence the K9 program had been reviewed to ensure patients remained free from abuse and harassment.

i. Upon request, he facility was unable to provide a policy, procedure, or documentation of risk assessment that delineated on which patients, and using which techniques, the use of the K9 would have been appropriate. The facility was unable to provide a policy, procedure, or documentation of risk assessment to eliminate abuse and harassment when K9s were used in patient care areas.

When asked for national guidelines for the use of K9s in a healthcare setting, the facility provided the National Police Canine Association (NPCA) Membership Book 2022-2023. This document read, the NPCA was a non-profit association dedicated to the training, development, and certification of law enforcement canine teams and their administrations. Review of the document did not reveal guidance for the use of law enforcement canine teams in a healthcare setting.

ii. On 1/31/2023 at 9:44 a.m., an interview was conducted with the interim director for public safety and security (Director) #7. Director #7 stated training for the K9 and handler was performed through a national police K9 instructor, and that this individual trained many police K9s in the region. When asked about safety guidelines for using K9s in a healthcare setting, Director #7 referenced the NPCA membership book and the facility's policies and procedures.

Director #7 stated the threshold for a K9 interacting with a patient should have been a patient actively assaulting staff or committing a crime. She explained dementia or a medical diagnosis that interfered with patient awareness of a situation should have precluded the use of K9s. Director #7 stated the standard operating procedure for K9 interactions was part of the K9 training which was performed through a third party vendor. Director #7 was unable to identify a facility document delineating these interactions.

iii. On 1/31/2023 at 11:00 a.m., an interview was conducted with the director of quality, infection prevention, and environment of care (Director) #8. Director #8 said the facility had collected data on the K9's impact on the reduction of workplace violence, but had not specifically gathered or assessed data related to the potential for patient abuse and harassment related to the K9 program. She further stated staff from the quality and risk departments had not been included in the initial K9 development project.

Director #8 stated she had developed concerns for patient safety due to scrutiny on the use of K9s within the facility. She explained this concern regarded patients' fear of the K9s leading to escalated reactions, with staff not realizing the K9 was the cause of the reaction. Director #8 also expressed concerns regarding dog allergies.

iv. On 1/31/2023 at 11:42 a.m., an interview was conducted with the director of risk management (Director) #9. Director #9 said she had concerns for how and when the K9s were deployed. She further expressed concern that a K9 loudly barking could have caused chaos and interfered with vital communication between care team members.

Director #9 stated she did not have enough information about the full scope of K9 deployment to fully understand the process. She expressed additional concerns surrounding deployment regarding the patient's airway, mobility, physical harm that could occur if a patient fought the K9, and anxiety or fear from the K9 barking and growling. Director #9 stated despite training, a K9 did not have critical thinking and it was unknown how the animal would react to any particular situation. She further stated the facility needed to achieve a balance between workplace violence prevention and patient safety.

v. On 1/31/2023 at 3:21 p.m., an interview was conducted with the chief executive officer (CEO) #10. CEO #10 stated discussion during the initial assessment of the K9 program was focused on injury prevention and workplace safety. He further stated he did not recall a conversation focused on patient safety.

Based on document review and interviews, the facility failed to ensure all instances of restraints were in accordance with a physician or other licensed practitioner in two of two medical records reviewed where a K9 (dog) participated, either from barking or with direct physical contact, in intimidating and restraining patients (Patients #1 and #2).

Findings include:

Facility policy:

According to the facility policy Restraints/Seclusion, the facility philosophy supports the limited and safe use of restraints/seclusion in all clinical settings through the development and promotion of preventative strategies and the safe and effective use of alternatives that prevent injury to patients and others.

A restraint is defined as any method (chemical or physical) of restricting an individual's freedom of movement, including seclusion, physical activity, or normal access to his or her body that is not a usual or customary part of a medical diagnostic or treatment procedure to which the individual or his or her legal representative has consented, and is not indicated to treat the individual's medical condition or symptoms, or does not promote the individual's independent functioning. Restraint use is defined by intent, rather than diagnosis or the type of restraining device or mechanism employed, and is specific to the patient's behavior. Restraint use is not to be used as a means of coercion, punishment, staff convenience, discipline, staff retaliation or to prevent unauthorized departure.

Restraint use within the facility is limited to situations with adequate and appropriate clinical justification based on a current individual assessment and only after the least restrictive interventions and alternatives have been considered and are deemed ineffective.

References:

According to the Security Department K9 Program Operations Manual, a canine (K9 or dog) is a facility-owned dog certified in obedience, agility, apprehension, handler protection, and scent discrimination. Dogs are trained as an intermediate level of force, generally used as a defense to protect a K9 officer or another individual from a verbal or physically escalated patient.

According to the National Police Canine Association Membership Book 2022-2023, the National Police Canine Association is a non-profit association dedicated to the training, development, and certification of law enforcement canine teams and their administrations.

1. The facility failed to ensure instances where a K9 intervened or came into physical contact with patients during instances where patients required de-escalation were done so in accordance with a practitioner's order.

a. A review of Patient #1's medical record revealed police brought her to the facility's emergency department on 12/29/22. She was assessed for altered mental status after she was found walking in the snow in socks and a dress. Patient #1 was placed on an M1 hold (an involuntary psychiatric/behavioral hold used to prevent an individual from leaving a facility when they were in imminent danger of harming themselves or someone else) by police prior to arriving at the ED.

Per Physician #5's documentation, Patient #1 presented as gravely disabled and anxious due to a psychotic disorder. Patient #1 was appropriate during her interactions with the physician. He wrote Patient #1 was easily re-directable and although she initially refused to take oral medication for the treatment of psychosis, she was not verbally or physically threatening to herself or others so he felt he did not have the legal right to restrain her. After Physician #5 completed his initial interview, Patient #1 suddenly rushed to the door in an attempt to leave and was restrained by multiple security guards. Physician #5 wrote that he did not witness and was not informed of any attempts by Patient #1 to harm staff.

Physician #5 wrote that social worker (SW) #4 was able to verbally de-escalate Patient #1, after which Patient #1 agreed to take two oral doses of an antipsychotic medication. Patient #1 then again attempted to leave the room. Physician #5 documented he returned to her room to see Patient #1 being held down by six to seven security guards, while the K9 was in the corner of the room loudly barking. Physician #5 assessed Patient #1 as extremely anxious, and that the K9 barking was the primary driver to the patient's escalated behavior and anxiety. Physician #5 wrote he had further concerns that the barking impeded communication between the care team and the security team.

Physician #5 documented he asked the handler to remove the K9 from the room, but the handler refused, as it was her intention to keep the other security officers safe. Physician #5 wrote security officers placed Patient #1 in restraints, without a physician's order. The physician's note further stated once security stepped out of the room, the Physician #5 noted the patient to be laying calmly in bed, not fighting the restraints, with stable vital signs and no evidence of agitation.

Review of the Other Orders section in Patient #1's medical record revealed an order placed by a different practitioner for wrist and ankle restraints; however, the order did not include utilizing the K9 during the de-escalation episode.

i. On 1/26/2023 at 10:02 a.m., an interview was conducted with Physician #5. Physician #5 stated during her ED admission Patient #1 did not fully understand where she was or the implications of the situation around her. He stated as Patient #1 did not present as a threat to herself or staff she did not meet the legal criteria for chemical restraint, and that SW #4 had already successfully verbally de-escalated her prior to the use of the K9.

Physician #5 stated he had requested the handler remove the K9 from Patient #1's room as he was concerned the K9 was causing her psychological harm. Physician #5 further stated as it became clear the handler was not going to remove the K9, he allowed the patient to be restrained so the security officers and the K9 would leave the patient's room. Physician #5 explained although he was unsure the patient required restraint, after the security situation was resolved the medications the patient had agreed to take started working which then allowed the restraints to be removed.

Physician #5 stated instances where a K9 was either barking or in physical contact with patients could be considered as a restraint and should have been conducted in accordance with a provider's order. Physician #5 further stated he was unaware of any evidence backing the use of a barking dog for managing patients' behavior.

ii. On 1/25/2023 at 4:51 p.m., an interview was conducted with SW #4. SW #4 stated he did not fear for his safety when he was with Patient #1 and did not feel restraints were medically indicated. SW #4 stated the handler determined when to deploy the K9, but that it was the physician's responsibility to order restraints. He said Patient #1 had experienced a violent sexual offense. SW #4 further stated the use of forcible restraint risked causing Patient #1 psychological trauma and retraumatization related to the sexual offense.

b. A review of Patient #2's medical record revealed police brought her to the ED on 12/24/22 due to disruptive behavior and intoxication. SW #4 documented Patient #2 arrived at the ED in handcuffs, but these were removed without incident. He further documented that she was crying and upset, causing her to become verbally aggressive. SW #4 wrote Patient #2 initially did not make threatening remarks, did not become physically aggressive, and did not attempt to leave the facility. SW #4 wrote Patient #2 became agitated due to the presence of security and the K9, which led security to hold her down. The K9 was deployed and was standing on Patient #2's chest while barking. SW #4 further wrote Patient #2 became physically aggressive only after security displayed physical aggression towards her. He documented that prior to this incident, Patient #2 was emotionally labile (emotions were changing and altering easily) but she was re-directable and responsive while speaking with him.

A physician's note documented Patient #2 was initially cooperative, but became physically violent towards herself and staff. The physician wrote Patient #2's escalated behavior necessitated injection of medication into the muscle for chemical restraint, and so Haldol (a drug to reduce psychosis) and Versed (a drug to reduce anxiety and cause sleepiness) were prescribed. The physician further wrote after the administration of the drugs, Patient #2 fell asleep. When she awoke, medical staff assessed her as no longer at risk for harm to herself or others and no longer intoxicated. Patient #2 was then discharged home.

Review of the Other Orders section in Patient #2's medical record revealed an order placed by a practitioner for wrist and ankle restraints; however, the order did not include utilizing the K9 during the de-escalation episode.

i. On 1/25/2023 at 4:51 p.m., an interview was conducted with SW #4. SW #4 stated a physician had deemed Patient #2 too intoxicated to safely leave the ED. He further stated Patient #2 was not violent or aggressive and that he was able to verbally de-escalate her, with the goal of preventing restraints. SW #4 stated the patient initially refused to voluntarily take oral medications, which is why restraints were ordered. SW #4 said it was not his assessment that Patient #2 presented to the ED with an active psychiatric concern. He explained as security guards held down Patient #2's upper body so the medication could be administered, she began kicking with her legs. SW #4 further explained the handler then deployed the barking K9 onto the patient's chest while the handler stood by the K9. SW #4 said after the medication was administered to Patient #2 he left the room due to the uncontrolled atmosphere.

ii. On 1/25/2023 at 10:43 a.m., an interview was conducted with social worker supervisor (Supervisor) #6, during which she discussed Patient #2's admission to the ED. Supervisor #6 stated the social work team felt Patient #2 required a physical exam, time for the alcohol to leave her system to allow for safe self-care, and then access to a ride home. Supervisor #6 stated the patient became verbally aggressive, which then led to the security team restraining her with the K9 deployed on top of her. Supervisor #6 expressed concern that this further traumatized the patient who was already experiencing having her rights taken away as she was being restrained.

Supervisor #6 explained in patients with psychosis, dementia, or under the influence of drugs or alcohol, interventions to reduce violence other than the use of a K9 may have been more appropriate. She further explained K9 interventions decreased the social work team's ability to build rapport with patients, in particular as the K9 team did not always give patients time to experience the effects of medications. Supervisor #6 said using force or restraint decreased the patient's trust and the effectiveness of the less invasive interventions such as providing simple comfort, such as offering a cup of coffee.

Supervisor #6 stated the barking K9 made it difficult to provide care to patients. She further stated the facility needed a procedure to ensure the K9 did not further escalate patients. Supervisor #6 explained the physician had ultimate responsibility for the care of the patient, and the K9 should have been removed from Patient #1's room at the request of the clinical team.

Supervisor #6 said adverse psychological effects of a K9 used as command presence or deployed on a patient could have included significant traumatic harm or increased trauma for an already traumatized patient. She further said if patients presented to the ED, they had likely already experienced the worst day of their lives and that it was the function of the ED care team to lessen the risk of trauma rather than add to it. Supervisor #6 said if the presence of a K9 in the facility deterred patients from seeking care, they would experience worsened medical conditions and deterioration in psychological status as they would not have access to referrals for behavioral health.

iii. On 1/26/2023 at 10:02 a.m., an interview was conducted with Physician #5. Physician #5 stated instances where a K9 was either barking or in physical contact with patients could be considered as a restraint and should have been conducted in accordance with a provider's order. Physician #5 further stated he was unaware of any evidence supporting the use of a barking dog for managing patients' behavior.

Based on the manner and degree of the standard-level deficiencies referenced to the Condition, it was determined the Condition of Participation §482.21 QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT was out of compliance.

A0286- The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will identify and reduce medical errors. The hospital must measure, analyze, and track adverse patient events. Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. Executive Responsibilities. The hospital's governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: That clear expectations for safety are established. Based on document reviews and interviews, the facility failed to ensure the quality assessment and performance improvement (QAPI) program analyzed patient events and implemented preventive actions. Specifically, the facility failed to investigate and implement actions in regards to patient events involving the K9 (dog) security program in two of two medical records reviewed where a K9 participated, either from barking or with direct physical contact, in intimidating and restraining patients (Patients #1 and #2).

Based on document reviews and interviews, the facility failed to ensure the quality assessment and performance improvement (QAPI) program analyzed patient events and implemented preventive actions. Specifically, the facility failed to investigate and implement actions in regards to patient events involving the K9 (dog) security program in two of two medical records reviewed where a K9 participated, either from barking or with direct physical contact, in intimidating and restraining patients (Patients #1 and #2).

Findings include:

Facility policies:

The Patient Safety Event Reporting/Sentinel Event Management policy read, the purpose is
to increase the general knowledge about patient safety events, their contributing factors, and
strategies for prevention. Harm is defined as any physical or psychological injury or damage to the health of a person. A patient safety event is defined as an event, incident or condition that could have resulted or did result in harm to a patient.

Procedure: Identification, immediate response, and reporting. Upon identification of a patient safety event, the patient care provider will immediately:perform necessary healthcare interventions to protect and support the patient's clinical
condition;s appropriate, perform necessary healthcare interventions to contain the risk to others;contact the patient's attending physician and other physicians, as appropriate, to communicate for further orders;enter the Patient Safety Event in the Occurrence Reporting System

The Use of Force policy read, canines deployed for any reason shall be utilized only as a reasonable use of force against subjects that present an immediate physical danger to themselves or others around them. Required action step: A security officer or a trained associate will document any use of physical force promptly, completely, and accurately using the incident reporting system. Any use of physical force will be documented promptly and accurately in the incident reporting system. Each individual reporting use of force in an incident report shall describe in detail the actions of the subject warranting the use of force, the specific force used in response to the subject's action, the subject's response to the use of force and how the subject was eventually controlled.

The facility approves the use of security K9 teams as a less than lethal weapon that shall be utilized only as a reasonable use of force against subjects that present an immediate physical danger to themselves or others around them and when the use of deadly force is not justified.

The Restraints/Seclusion policy defined a restraint as any method (chemical or physical) of restricting an individual's freedom of movement, including seclusion, physical activity, or normal access to his or her body that is not a usual and customary part of a medical diagnostic or treatment procedure to which the individual or his or her legal representative has consented, and is not indicated to treat the individual's medical condition or symptoms, or does not promote the individual's independent functioning.

Restraint use within the facility is limited to situations with adequate and appropriate clinical justification based on a current individual assessment and only after the least restrictive interventions and alternatives have been considered and are deemed ineffective.

References:

The Variance Investigation Process guideline provided by the facility read, Manager Expectations: File managers are to complete an initial follow up within 24-48 business hours of receiving an event notification. The intent is to acknowledge the event and to provide a plan to action to resolve the event and to prevent similar events from occurring. Investigate the event answering the following questions: Was there a deviation in care? Was there harm to the patient? What was done to resolve the issue? If a deviation occurred, identify what actions were taken for the unit/staff follow-up. It is the responsibility of the File Manager or Department Leadership to "close the loop" with front line associates on events including sharing lessons learned, trends or 1:1 follow up as appropriate.

Leadership Expectations: Leadership are to provide oversight and support to File Managers and to identify and assist in removing barriers and in resolving or eliminating potential harm. Collaborate with File Managers to review trends and identify areas of improvement. Risk/Safety Manager Expectations: Review events, evaluate need for Root Cause Analysis, and assist File Managers in identifying and eliminating harm.

The facility Health Risk Management and Patient Safety Plan read, the risk management program is designed to protect patients, associates, providers and visitors from avoidable injury. Risk Management is responsible for identification, investigation and management of patient and visitor events including the event reporting program. The event reporting program is used to proactively identify, track and trend events that have the potential to cause adverse patient outcomes. Other processes may be used to identify risks such as audits of the electronic health record and proactive risk assessment. The program is also responsible for facilitation of the root cause analysis process, and to promote a culture of safety by addressing patient safety events and trends through performance improvement initiatives using high- reliability tools and principles.

1. The facility failed to ensure patient events involving the deployment of the K9 security force were analyzed and preventative measures were implemented to prevent potential patient harm.

a. Medical records revealed events in which the K9 security force was used in a manner which was not consistent with facility policy, however there was no review or implementation of preventative actions implemented.

i. A review of Patient #2's medical record revealed police brought her to the Emergency Department (ED) on 12/23/22 at 11:18 p.m. due to disruptive behavior and intoxication. Per nursing documentation, Patient #2 was crying, upset, and attempting to use the staff computer in her ED room. A RN then documented the patient was becoming physically and verbally disruptive while displaying suicidal ideation. On 12/24/23 at 12:20 a.m., a verbal order for locking limb restraints was obtained from Physician Assistant (PA) #11.

On 12/24/22 at 1:58 a.m., social worker (SW) #4 documented Patient #2 arrived at the ED in handcuffs, but these were removed without incident. He further documented the patient was crying and upset, causing her to become verbally aggressive. SW #4 wrote Patient #2 initially did not make threatening remarks, did not become physically aggressive, and did not attempt to leave the facility. SW #4 wrote Patient #2 became agitated due to the presence of security and the K9 security dog, which led security to hold her down. The K9 was deployed and was standing on Patient #2's chest while barking. SW #4 further wrote Patient #2 became physically aggressive only after security displayed physical aggression towards her.

On 12/24/22, a patient event was reported. On 1/3/23 the facility documented a risk and security review was completed. On 1/9/23, the patient event documentation read the event was discussed with staff involved. Upon request, the facility was unable to provide evidence of preventive actions or process changes implemented regarding this event to prevent future potential patient harm.

Review of the medical record for Patient #2 revealed the use of force, specifically the use of the K9 security dog, was not in accordance with the facility's Use of Force policy, as there was no evidence the patient presented an immediate physical danger to themselves or others around them to warrant use of force. The record further revealed the presence and/or deployment of the K9 dog contributed to the patient's escalated behavior and impeded communication between staff during an episode of restraint. However, there was no evidence the events were reviewed to determine whether harm including psychological or physical injury occurred to the patient due to the use of the K9 security dog, or to identify whether staff had followed facility policy for restraint use and use of force.

The facility was unable to provide evidence of preventive actions implemented in response to the event involving Patient #2 to reduce the risk of patient harm due to use of the K9 dog.

ii. A review of Patient #1's medical record revealed police brought her to the facility's ED on 12/29/22 at 6:31 p.m. due to altered mental status. Patient #1 was placed on an M1 hold (an involuntary psychiatric/behavioral hold used to prevent an individual from leaving a facility when they were in imminent danger of harming themselves or someone else) by police prior to arriving at the ED.

According to documentation entered by the patient's RN, SW #4, and Physician #5, Patient #1 was attempting to leave her room and demonstrated behaviors such as crying, hiding behind blankets, anxiety, timidity and unusual behaviors. However, staff and the provider documented the patient was not verbally or physically threatening to herself or others; she was redirectable and could be verbally de-escalated; and agreed to oral antipsychotic medication. There was no evidence in the medical record Patient #1 presented an imminent risk or danger to herself or others.

Physician #5 and SW #4 documented the deployment of multiple security guards and the K9 dog in response to Patient #1's attempts to leave her room. Both Physician #5 and SW #4 documented the K9 dog was barking loudly during the interaction with Patient #1, and that the presence of the dog further escalated the patient's anxiety and behavior as well as hindering caregiver communication in the room. According to the notes, Physician #5 asked the dog's handler to remove the K9 from the room but the handler refused to do so, and security placed Patient #1 in restraints. (Cross Reference A-0145).

The facility was unable to provide evidence of preventive actions implemented in response to the event involving Patient #1 to reduce the risk of patient harm due to use of the K9 dog.

b. Interviews

i. On 1/25/23 at 4:51 p.m., an interview was conducted with SW#4. SW#4 stated the use of the K9 dogs did not de-escalate patients and was not appropriate when patients were already aggressive. In regards to the patient events involving Patients #1 and #2 in which the K9 security dog was utilized, SW #4 stated he was not interviewed by unit or facility leadership regarding any of the events.

ii. On 1/25/23 at 10:41 a.m., an interview was conducted with SW #6. SW #6 stated a discussion had occurred among department staff in regards to the patient events involving the K9 security dog. However, SW #6 stated there were no changes implemented in response to the events.

iii. On 1/26/23 at 10:01 a.m., an interview was conducted with Physician #5. Physician #5 stated a meeting was held to discuss the patient events involving the use of the K9 dog, however he was not aware of any actions taken or changes made.

iv. On 1/31/21 at 11:00 a.m., the director of quality, infection prevention and environment of care (Director) #10 was interviewed. Director #10 stated the director of risk management (Director) #9 and staff from the Patient Safety Department were responsible to review and analyze patient safety events, including any events involving the K9 security program. She stated the quality and patient safety departments had not been involved in the initial project to implement use of the K9 security program in the facility, and that she and others in those departments had been "leery" of the use of a K9 dog in the facility. Director #10 stated she was not aware of any risk assessment which was conducted regarding the use of a K9 dog in patient care environments.

Director #10 stated the events involving the use of the K9 security dog had been discussed at meetings with ED staff and security personnel. However, she stated she did not know if those discussions involved reviewing the use of the K9 dog to determine whether patients experienced psychological harm.

Director #10 stated she was previously unaware of concerns brought forward from staff for patient safety during episodes in which the K9 security dog was utilized. She stated her concerns included the use of a dog to physically lay on a patient until restraints could be applied. She stated other patient risks included a patient's potential fear of dogs, allergies to dogs, or patients becoming further triggered in their behaviors by the presence of the dog.

v. On 1/26/23 at 9:17 a.m., an interview was conducted with Director #9. Director #9 stated a risk evaluation was not conducted prior to implementation of the K9 security program at the facility. Director #9 further stated she performed the individual investigations for patient events in which the K9 security dog was deployed, however she stated there was no tracking or trending being conducted regarding the utilization of the K9 security program.

Director #9 stated a debrief had occurred in response to the patient safety event reports regarding use of the K9 security program. She stated as a participant in the debrief she was concerned about the handler's failure to stand down when the provider asked for the K9 to be removed from the room. She was unable to specify whether there was discussion at this meeting to determine whether the use of the K9 dog had resulted in patient harm. Director #9 stated there were no minutes or other documentation of the debrief meeting.

Director #9 stated there were multiple concerns for patient safety when the K9 dog was deployed, such as the dog's barking creating an out of control environment and impairing vital communication, the dog lying on a patient and potentially compromising the patient's airway or mobility, patient anxiety and fear in response to the dog, and the unpredictability of a dog's reactions in a situation.

Director #9 stated the facility should have conducted a cause analysis of the events involving the use of the K9 security dog, because a cause analysis would have investigated the systems and processes involved. She stated after the debrief meeting she would have expected coaching and education to be provided to the K9 handler involved in the events. However, the facility was unable to provide evidence this coaching and education had occurred, nor was there evidence of preventive actions or process changes to address the patient safety concerns which were discussed at the debrief meeting and described by Director #9.

Director #9's interview was in contrast to the facility's patient safety and risk management policies and processes, which read the facility's risk management department was responsible to investigate patient events, track and trend events with the potential to cause adverse patient outcomes, conduct risk assessments, facilitate the root cause analysis process, and to identify contributing factors and strategies for prevention of events in which patient harm, including physical or psychological injury, could result.