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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'S RIGHTS was out of compliance.

A-0154 Restraint or seclusion. All patients have the right to be free from physical or mental abuse, and corporal punishment. All patients have the right to be free from restraint or seclusion, of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff. Restraint or seclusion may only be imposed to ensure the immediate physical safety of the patient, a staff member, or others and must be discontinued at the earliest possible time. Based on video surveillance observations, document review, and interviews, the facility failed to ensure restraints were implemented according to national standards and facility policy in four of five patients' medical records reviewed who were restrained or had physical interventions initiated by security officers (Patients #6, A, E, and I).

Based on video surveillance observations, document review, and interviews, the facility failed to ensure restraints were implemented according to national standards and facility policy in four of five patients' medical records reviewed who were restrained or had physical interventions initiated by security officers (Patients #6, A, E, and I).

Findings include:

Facility policies:

The Restraints and Seclusion Violent Patient policy read, restraints are any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely. This includes any soft limb or leather restraints, mitts or a drug or medication when it is used as a restriction 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. Restraints and/or seclusion is limited to clinically appropriate situations. Restraint and/or seclusion is utilized when alternative strategies have failed. The least restrictive intervention is used. Restraints and/or seclusion are used to protect the patient's safety or when patient behavior threatens the safety of staff or others. During the use of restraints and/or seclusion, the patient's dignity and well-being are preserved. Security may be contacted to assist with the application or removal of violent restraints. A physician order is required for restraints and seclusion. If no physician is present, a registered nurse (RN) may initiate the restraint or seclusion and notify the physician as soon as possible to obtain an order. A physician order specifies the type of violent restraint including hard restraints, physical hold, chemical, or seclusion.

The Patient Holds Policy read, the purpose of the policy is to maintain a safe environment of all personnel, patients, and visitors by outlining the guidelines for placing and managing patients on a hold. Physical restraint: In accordance with Colorado Revised Statute §18-1-703(e), a duly licensed physician, an advanced practice nurse, or a person acting under his/her direction (e.g., a security officer acting under the direction of a physician ordered hold), may use reasonable and appropriate physical force for the purpose of administering a recognized form of treatment which he reasonably believes to be adapted to promoting the physical or mental health of the patient.

The Security Officers: Continuum of Force policy read, it is the security officer's duty to maintain a controlled and safe environment, especially when dealing with difficult people and situations, using the least restrictive measures possible. The Continuum of Force is a tool to ensure the safety of our environment, both for those persons who may be escalating and require force to intervene, and those who require protection from an escalating person. The continuum of force starts with the physical presence of a security officer including the use of multiple security officers or law enforcement officers as back-up or a larger show of force. The next step is verbal direction: talking and negotiating to defuse the situation. The third step is Soft Empty Hand Techniques including joint locks, pressure points, and strength techniques; the fourth step is Hard Empty Hand Techniques including blocking strikes, defensive counterstrikes, and shoulder pin restraint.

References:

The Human Factor Research Group (HFRG) Threat Pattern Recognition (TPR) Manual read, the HFRG definition for One-Plus-One Theory is the most conservative use of force theory, based upon the concept of responding to resistance with a proportional use of force. This theory advocates that officers can use one level of force higher than the level of resistance used by the subject. Soft empty-hand techniques are designed to control passive or defensive resistance and are used when verbal direction/commands are not effective. They include strength techniques, joint locks, pressure points, or a knee strike/distraction technique to the subject's thigh (to prevent resistance from the escort position). Hard empty-hand control techniques are designed to control active aggression but can be used to control defensive resistance when lower forms of control have failed or the officer "believes" lower forms of control will fail. Examples provided of hard empty-hand control techniques include defensive counterstrikes. These techniques have a probability of injury in the form of bruises, contusions, or lacerations. The HFRG definition for pain compliance is the use of the stimulus pain to control resistive behavior. The key to using pain compliance techniques is understanding the principle works on a punishment/reward concept. Once the pain exceeds the subject's pain threshold, the subject usually decides to stop resisting. When the subject stops resisting, the officer rewards the subject by relaxing the pressure, thus relieving the pain.

The Verbal Judo (VJ) Instructor Manual read, verbal judo is the use of words to achieve professional objectives. Verbal judo is used when the speaker is in conflict with the audience. Verbal judo is considered skillful communication that is target-based, and its purpose is the de-escalation of the conflict being experienced.

The Security Officer position description read, the security officer maintains the safety and security of, and provides assistance to employees, members of the medical staff, patients and visitors. The security officer is available to assist visitors and staff; intervenes with difficult or disruptive patients and/or visitors with the lowest level intervention possible; keeps accurate security logs and completes security reports for significant incidents; maintains up-to-date training in low-level interventions, high-level interventions, TPR, Taser training and use of restraints.

1. The facility failed to ensure nursing and security staff utilized least restrictive measures in accordance with facility policies to de-escalate aggressive or assaultive patients.

A. Review of surveillance videos

i. Review of the behavioral health unit surveillance video dated 8/18/23 at 3:25 a.m. revealed Patient #6 was in a seclusion room (an empty room where the patient was taken for calming purposes). When staff opened the door to the seclusion room, Patient #6 jumped up and tried to push through the door. A security officer held Patient #6 by the shoulders against the wall in the hallway and escorted the patient to the bathroom. Patient #6 then held the bathroom door closed. Once the door was opened, the security officer held the patient's arms against the sides of her body and carried her down the hall to the seclusion room. The security officer implemented an arm bar (pulled the patient's arm behind her back to control her movements) to move Patient #6 down to the bed and then converted to a wrist lock (holding the wrist in a way that prevented movement) when Patient #6 was on the bed in the seclusion room. The security officer straightened Patient #6's legs by grabbing her feet, while still maintaining his wrist lock. Patient #6 stopped resisting after 20 seconds and the security officer released her and exited the seclusion room.

ii. Review of the behavioral health unit surveillance video dated 8/26/23 at 8:05 p.m. revealed Patient #6 exited a patient room and hit the glass at the nurse's station. She then paced down the hall and tried to open doors along the hall and at the nurse's station. Patient #6 stared into the nurse's station and then walked out of view. Patient #6 returned to the nurse's station, spoke into the intercom, laid down on the ground, got up from the ground, tried to open more doors, and walked back to her room.

A registered nurse (RN) was observed using the phone at the nurse's station and shortly thereafter, security officers arrived at the unit. Staff entered the patient's room and then backed out of the room. Patient #6 followed the staff out of the room and reached toward the RN. A security officer initiated a straight armbar on the patient. The security officer returned Patient #6 to her room with the straight armbar in place.

This was in contrast to the Security Officers: Continuum of Force policy which read the security officer's duty was to maintain a controlled and safe environment using the least restrictive measures possible. The continuum of force started with the physical presence of a security officer and the next step was verbal redirection to defuse the situation. On review of the surveillance videos, there was no evidence security officers attempted to verbally redirect Patient #6 before they initiated physical interventions such as holds, armbars and wrist locks.

This was also in contrast to the Restraints and Seclusion: Violent Patient policy which read, restraints were utilized when alternative strategies failed and the least restrictive intervention was used.

B. Medical record review and document review

i. Review of facility documents revealed eight safety events involving Patient #6 in which staff implemented physical holds and other physical techniques when the patient was escalated. The events occurred throughout Patient #6's admission from 8/14/23 to 9/22/23. Examples included:

a. A safety event report dated 8/18/23 at 3:25 a.m. revealed a nurse and a security officer held Patient #6 in place by immobilizing her arms. The report read, a nurse asked security for assistance to use physical management in order to return the patient to seclusion. Security attempted to use a transport wrist lock on the patient's left arm while the nurse secured her right arm. The report also read, the patient resisted heavily during this process and required repeated verbal directions from security to get her to lie down on the seclusion room bed.

The safety event report was in contrast to the video surveillance from 8/18/23 at 3:25 a.m., which showed the security officer also placed the patient in multiple straight arm bars and a wrist lock once she had returned to the seclusion room from the bathroom. The safety event failed to document these subsequent holds, straight arm bars and wrist locks.

b. A safety event dated 8/26/23 at 8:05 p.m. revealed nursing staff requested security's assistance in order to administer intramuscular (into the muscle) medications to Patient #6. The event report read that a security officer executed a straight arm bar to lower the patient onto the bed to hold her immobile while staff administered medications. The report further read, the security officer then released the patient who retaliated. The security officer again implemented a straight arm bar on the patient to lower her to the bed and the hold lasted several seconds.

The safety event report was in contrast to the video surveillance from 8/26/23 at 8:05 p.m., which showed the security officer implemented additional physical interventions during the event. The security officer executed another straight armbar on Patient #6 and held her against the hallway wall, then led the patient into the room with the armbar in place. The safety event report failed to document these additional physical interventions.

c. Six similar safety events involving Patient #6 were reviewed. The event reports revealed staff utilized additional physical interventions during interactions with the patient, which included holds for immobility, joint locks and escort holds.

Medical record review revealed Patient #6 presented to the facility on 8/14/23 for treatment of bipolar I disorder (a mental condition marked by alternating periods of elation and depression) with psychosis (a mental disorder characterized by a disconnection from reality). The medical record revealed provider's orders were present only for security holds which were necessary to administer emergency medications (medications administered to calm a patient with disruptive behaviors). However, there were no provider's orders for other security holds that did not involve the administration of emergency medication, such as the physical holds implemented to escort the patient to seclusion as documented in the safety event reports.

ii. A safety event involving Patient A was reviewed. According to the report, the physician requested security staff to escort Patient A to the bus stop because the patient was discharged but refused to leave. The event revealed the patient began yelling at the security officers and advanced toward the security officers. A security officer employed a palm heel strike (using the palm of the hand to strike a person) on the patient. The patient continued to demonstrate aggressive behaviors and physically struck a staff member with an open hand. Several security officers then executed a takedown of the patient and brought him to the ground.

Medical record review revealed Patient A presented to the facility on 8/8/23 after a motor vehicle crash for treatment of alcohol intoxication. The review revealed after Patient A was found to be medically stable, he was discharged and security escorted him out of the ED at the physician's request. There was no documentation in the medical record of the physical holds and heel strikes security officers implemented during the event. In addition, there was no provider's order for the physical hold which was utilized to escort the patient out of the ED, as documented in the associated safety event.

iii. A safety event involving Patient E was reviewed. On 8/27/23 at 1:30 a.m., the patient was placed into a room in the emergency department (ED). The safety event revealed Patient E began yelling and making threats at staff members. The physician discharged the patient and requested security staff to escort him out of the department. Once outside of the ED, Patient E continued threatening the security staff and reached for something in his pockets. A takedown was executed and a wrist lock was applied once Patient E was on the ground.

Medical record review revealed Patient E presented to the facility on 8/27/23 for treatment of alcohol withdrawal. Review revealed Patient E was found to be medically stable and was discharged due to aggressive behavior and threatening staff. Review of the medical record revealed there was no documentation of the takedown and wrist lock that were documented in the associated safety event, nor were there provider orders for the security holds that were implemented during the event. In addition, there was no evidence from the medical record showing alternative and less restrictive measures attempted by security staff prior to implementing physical force.

iv. A safety event involving Patient I was reviewed. On 7/26/23 at 11:00 a.m. staff entered Patient I's room to give medications. According to the report, Patient I threatened to harm staff if they moved closer to him and raised his hands at one of the security officers. Security officers then grabbed Patient I's hands and two officers took the patient to the floor to physically immobilize him. After staff administered the medication, the security officers released the patient with instructions for him to remain on the floor until they exited the room. The safety event report read, once staff started to exit the room Patient I threatened the security officers, who then used multiple palm heel strikes to maintain distance from the patient until staff safely exited the room.

Medical record review revealed Patient I was admitted to the facility from 7/8/23 to 8/10/23 for treatment of schizophrenia (a mental condition involving a breakdown in the relation between thought, emotion, and behavior). The nursing notes on 7/26/23 documented that a brief hold was performed during the administration of emergency medication. However, there was no documentation in the patient's medical record of the multiple palm heel strikes security executed as they left the patient's room.

The review safety events for Patients #6, A, E, and I were in contrast to the Security Officers: Continuum of Force policy which read, it was the security officer's duty to maintain a controlled and safe environment using the least restrictive measures possible. The continuum of force started with the physical presence of a security officer and the next step was verbal direction to defuse the situation.

The reviews were also in contrast to the Restraints and Seclusion: Violent Patient policy which read, a restraint was anything that immobilized or reduced the ability of a patient to move his or her arms, legs, body, or head freely, including when they were used as a restriction to manage the patient's behavior or restrict the patient's freedom of movement and were not a standard treatment for the patient's condition. Restraints were utilized when alternative strategies failed and the least restrictive intervention was used. A physician order was required for restraints and specified the types of restraints ordered. Documentation of restraint use included the time the physician was notified, the type of intervention used, the patient's immediate situation, and the patient's reaction to the intervention.

The reviews were also in contrast to the Patient Holds policy which read, the purpose of the policy was to maintain a safe environment of all personnel and patients by outlining the guidelines for placing and managing patients on a hold. Physical restraint: In accordance with Colorado Revised Statute §18-1-703(e), a duly licensed physician, an advanced practice nurse, or a person who acted under his/her direction such as a security officer who acted under the direction of a physician ordered hold, was able to use reasonable and appropriate physical force for the purpose of administering a recognized form of treatment which he or she reasonably believed to be adapted to promoting the physical or mental health of the patient.

C. Restraint log review

A review of the facility's restraint log revealed apart from holds that were utilized specifically for the administration of emergency medications, there was no documentation in the restraint log of the holds utilized by security officers that were identified in patient safety events and patient medical records.

D. Interviews

i. Interviews revealed security staff were to utilize physical interventions, such as holds and wrist locks, in situations when alternative strategies or de-escalation techniques were not successful. According to interviews, if security utilized physical interventions the intervention was considered a restraint and therefore required documentation of the intervention in the patient's medical record, and a provider order for restraint was required.

a. On 10/19/2023 at 7:41 a.m., an interview with RN #2 was conducted. RN #2 stated de-escalation classes were provided by the facility every two years and included training in verbal judo. RN #2 stated when verbal judo was not effective, security and staff worked together to execute hands-on restraints. She stated security helped with various holds such as wrist locks to get larger patients into restraints. RN #2 stated when patients were placed in restraints, a provider needed to place the order, and the documentation in the medical record needed to include the timing and details of the event as well as the reason for the restraint. RN #2 also stated there was a risk of patient injury when security officers without a clinical background used hands-on techniques with patients.

This was in contrast to medical record reviews which revealed a lack of provider's orders for physical holds placed by security officers as well as incomplete documentation of the type and timing of the physical interventions utilized.

b. An interview was conducted on 10/26/23 at 9:29 a.m. with RN ED Manager (Manager) #5. Manager #5 stated if staff placed the patient into a hold, there needed to be documentation in the medical record along with the provider's orders for the hold.

c. On 10/19/23 at 12:58 p.m. and on 10/26/23 at 8:12 a.m., interviews with the RN clinical manager of the behavioral health inpatient unit (Manager) #4 were conducted. Manager #4 stated if techniques such as verbal redirection did not change patient behavior and patient or staff safety was at risk, restraints could be implemented. She stated provider orders for restraints were necessary any time the movement of a patient was restricted. Manager #4 stated monitoring patients in restraints was a staff priority due to concerns for patients' hydration levels, toileting needs, and mental status, in addition to not keeping patients in restraints any longer than needed to de-escalate behaviors. Manager #4 also stated when emergency medications were administered to patients and staff called security to help hold the patients, this was considered a physical restraint.

This interview was in contrast to medical record reviews which revealed a lack of provider orders for physical holds placed by security officers.

This interview was also in contrast to the review of the restraint log which revealed a lack of documentation of the physical holds identified in the safety report reviews, medical record reviews and security footage review, apart from those holds necessary to administer emergency medications.

d. On 10/18/23 at 8:34 a.m. an interview with security supervisor (Supervisor) #10 was conducted. Supervisor #10 stated he provided oversight to the security officers and certified the officers in TPR (threat pattern recognition). He stated in an unsafe situation security officers started with verbal judo to de-escalate patients. Supervisor #10 stated if this was not effective, TPR was the safest way to control patients without causing patient injury. For instance, he stated a palm heel strike was intended to push someone back when that person was attacking and would not cause injury to the patient. Supervisor #10 stated pain compliance, which was a pressure point (points on the body sensitive to pressure) technique, was used to ensure patients released objects or other people when necessary. Supervisor #10 stated this technique caused discomfort to the patient but no injury. He stated there was no risk to patient safety when security officers went hands-on with patients, even if the security officer did not know the patient's complete medical history.

This was in contrast with the Human Factor Research Group (HFRG) Threat Pattern Recognition (TPR) Manual, utilized by staff as guidance for de-escalation techniques which read, these techniques had a probability of injury in the form of bruises, contusions, or lacerations.

e. On 10/19/23 at 12:11 p.m., an interview with the director of nursing (DON) #6 was conducted. DON #6 stated provider orders for restraints were necessary for patient and staff safety. She stated security officers protected staff when they implemented hands-on techniques with patients and these techniques were not classified as restraints. DON #6 stated once a patient chose to attack staff, that patient ceased to be a patient and security and staff members had a right to respond to the situation. She stated if the person calmed down, this person could choose to become a patient again. DON #6 stated TPR techniques were appropriate for use in a hospital setting.

f. On 10/19/23 at 12:20 p.m., an interview with the medical director of the ED (Physician) #3 was conducted. Physician #3 stated provider orders were necessary to restrain a patient. He stated providers had discretion over the type of restraints ordered for a patient if de-escalation techniques failed. Physician #3 stated it was important to have clinical oversight when dealing with a patient in restraints to ensure the patient's safety. He stated if staff restrained a patient without a provider order this created a higher risk situation for the patient. Physician #3 also stated if patients were not monitored by nursing staff while in restraints it was possible to miss signs of distress, including difficulty breathing.

This interview was in contrast to the review of medical records and safety events which revealed a lack of provider orders for the holds implemented by security officers, apart from those placed for emergency medication administration.

g. On 10/30/23 at 12:55 p.m., an interview with the chief medical officer (CMO) #23 was conducted. CMO #23 stated the facility was concerned with staff's ability to protect themselves from patients. He stated security staff used techniques that escalated in severity in order to address patient behaviors. He stated these techniques included the use of pressure point techniques which caused mild pain. CMO #23 stated the physical techniques employed by security officers did not pose a risk to patient safety.

This was in contrast with the Human Factor Research Group (HFRG) Threat Pattern Recognition (TPR) Manual, utilized as guidance for de-escalation techniques which read, these techniques had a probability of injury in the form of bruises, contusions, or lacerations.

ii. Interviews further revealed facility leadership developed policies related to how security officers were to utilize and initiate physical interventions based on guidance from TPR. Interviews further revealed although the TPR manual was designed for application in law-enforcement settings, the facility had adopted TPR guidance for application with patients receiving care in the hospital setting.

a. On 10/18/23 at 1:18 p.m. and on 10/30/23 at 12:30 p.m., interviews with the director of security (Director) #1 were conducted. Director #1 stated he was responsible for researching and writing the facility's security policies which were then reviewed by leadership. He stated he had used the TPR manual as a resource and standard when he created the facility's Continuum of Force policy. Director #1 stated TPR was not healthcare oriented. He stated he had chosen TPR as a resource for the policy and to certify the facility's security officers in de-escalation and behavior management techniques because TPR was used in a law enforcement setting and he felt this applied to a healthcare setting as well. Director #1 stated he trusted the company to have done the research needed to incorporate national standards for hospital use into their training guides.

Director #1 stated security officers started with verbal de-escalation when interacting with aggressive or assaultive patients before moving to hands-on techniques. Director #1 stated TPR allowed security officers to respond to a behavior, and if the patient's behaviors escalated the officers could go one level above that behavior in order to de-escalate. He stated there was always a risk to going hands-on with a patient, so it was important to start with verbal de-escalation techniques.

This was in contrast to the review of safety events and medical records which did not reveal consistent use of de-escalation techniques to manage patient behavior.

In addition, upon review of the TPR manual, there was no evidence the TPR guidelines were designed or validated for healthcare settings to include guidance for how to implement TPR techniques for patients with acute medical and psychiatric conditions.

b. On 10/18/23 at 12:05 p.m., an interview with vice president and general counsel (VP) #12 was conducted. VP #12 stated the director of security (Director #1) developed security policies and facility leadership then approved the policies. She stated she relied on the expertise and training of Director #1 and the safety and security manager (Manager #7) to develop policies and oversee the security officers. VP #12 stated she believed policies and techniques created from the TPR manual were appropriate for use in a hospital setting. She also stated security officers escalated management of aggressive or assaultive patients appropriately. VP #12 further stated there was always a risk of injury to the patient when staff went hands-on with a patient.

Based on interviews and document review, the facility failed to ensure quality assurance and performance improvement (QAPI) staff reviewed and analyzed safety events and concerns brought forward by staff and then implemented follow-up improvement activities. This failure affected nursing services, patient rights, and respiratory therapy services. (Cross reference A-1163, A-0154, A-0392, and A-0395).

Findings include:

Facilities policies:

The Safety-Events-Management policy read, the purpose is to provide an effective mechanism to identify safety risks and establish a consistent process for the reporting of safety events. Safety Events are used for ongoing monitoring, tracking, trending, and evaluation for improvement activities. Safety events are an early warning system which contributes to improved quality and patient safety. The Quality and Risk Management departments are responsible for the management of the safety event reporting system and will assign safety events to appropriate department managers or leaders. Leaders assigned follow-up are responsible for ensuring appropriate follow-up is documented within the safety event system.

The Restraints and Seclusion: Violent Patient policy read, restraints and/or seclusion is limited to clinically appropriate situations. Restraint and/or seclusion is utilized when alternative strategies have failed. The least restrictive intervention is used. Restraints and/or seclusion are used to protect the patient's safety or when patient behavior threatens the safety of staff or others. During the use of restraints and/or seclusion, the patient's dignity and well-being are preserved. Security may be contacted to assist with the application or removal of violent restraints. A physician order is required for restraints and seclusion. If no physician is present, a registered nurse (RN) may initiate the restraint or seclusion and notify the physician as soon as possible to obtain an order. A physician order specifies the type of violent restraint including hard restraints, physical hold, chemical, or seclusion. For assessment and monitoring, an initial one-hour face-to-face is completed within one hour of initiating restraint or seclusion by a physician or RN, the physician is notified of the RN's findings as soon as possible after completion, the one-hour face-to-face assessment and documentation including the type of intervention used, the patient's immediate situation, and the patient's medical and behavioral condition.

According to the Security Officers: Taser Use and Safety policy, approved by chief executive officer (CEO) #11, the purpose is to describe the procedures necessary to ensure Security personnel who are empowered to carry and use a Taser do so safely and legally. The Taser device causes strong muscle contractions, usually rendering a subject temporarily unable to control his or her movements. Under certain circumstances, these contractions may impair a subject's ability to breathe. If a person's system is already compromised by overexertion, drug intoxication, stress, or pre-existing medical or psychological conditions, including the use of a Taser device may have an additive effect in contributing to cumulative exhaustion, stress, cardiovascular conditions, and associated medical risks. When the Taser is used against a subject, they must be immediately evaluated by trained healthcare professionals and monitored for the individual's safety.

According to the Security Officers: Continuum of Force policy, approved by CEO #11, the continuum of force starts with the physical presence of a security officer including the use of multiple security officers or law enforcement officers as back-up or a larger show of force. The next step is verbal direction: talking and negotiating to defuse the situation. The third step is Soft Empty Hand Techniques including joint locks, pressure points, and strength techniques; the fourth step is Hard Empty Hand Techniques including blocking strikes, defensive counterstrikes, and shoulder pin restraint.

The Informed Consent and Informed Refusal policy read, the purpose is to ensure that any patient receiving surgery or invasive medical procedures is fully informed by the provider providing the care, treatment, or service as to all risks, benefits, side effects and alternatives prior to giving consent as well as to define the obligations in obtaining and documenting informed consent by medical staff and hospital personnel. Informed consent is required for the transfusion of blood (the process of receiving blood through the veins) or blood components.

The Limited English Proficiency: Interpretation Services policy read, the purpose is to emphasize the importance of effective communication between patients and their providers of care, treatment, and services. Effective patient-provider communication is necessary for patient safety. Patients with Limited English Proficiency (LEP) are more likely to experience adverse events than patients who speak English proficiently. A qualified interpreter is required at all key points in a patient's care: admission, obtaining history, assessment, explanation of treatment and test results, informed consent, and discharge instructions. The facility will inform persons with LEP of the availability of language assistance by providing written notice in languages persons with LEP will understand. On an ongoing basis, the facility will assess changes in demographics, types of services or other needs that may require reevaluation of this policy and its procedures. In addition, the facility will regularly assess the efficiency of these procedures, including but not limited to mechanisms for securing interpreter services, equipment used for the delivery of languages assistance, complaints filed by persons with LEP, and feedback from patients and community organizations.

The Code Blue and Emergency Response policy read, the purpose is to outline resuscitation and emergency response to life-threatening emergencies in all facility locations. The goal is prompt resuscitation of persons who suffer a cardiopulmonary arrest (lungs or heart stop working). Within the facility, the Code Blue internal designated code team responds to emergencies in the hospital. Staff are trained to recognize and respond to resuscitation emergencies according to where they work, their certifications, and within their scope of practice. ED, Surgery and NICU do not routinely use the Code Blue team. A Code Blue will be called in these areas if additional resources are needed. If an emergency airway is needed, page anesthesia. If anesthesia is unavailable, the ED provider is the backup. Performance review and improvement is completed through the Code Blue and Emergency Response Review Committee. This group reviews cases and data to identify and suggest practice and system improvements in resuscitation performance, education, and training.

References:

According to the Quality and Patient Safety Council Agenda meeting minutes on 1/25/23, Safety Event Summary: Patient Safety Event System (PSES), safety events are reviewed Monday through Friday by leaders, risk and quality, and event follow up is assigned. Follow-up on events occurs by leaders including closing the loop with the submitter. After follow-up, an event closure team reviews and classifies the event for trends. The Safety Event Committee reviews trends and tracks quality reviews being done. Safety Event Classification: Serious Safety Event (SSE): reaches the patient; results in moderate to severe harm or death. All Serious Safety Events receive a Quality Review. Precursor Safety Event (PSE): reaches the patient, results in minimal harm or no detectable harm. All Precursor Safety Events with Harm are reviewed by the Safety Event Committee to see if a Quality review is needed.

The Healthcare Performance Improvement (HPI) Safety Event Classification (SEC) & Serious Safety Event Rate (SSER) Patient Safety Measurement System for Healthcare read, precursor safety events focus on minor harm or no harm. The term precursor is a deliberate one because regarding these events as potential "precursors" to more serious events reinforces that they are equally important to address and pay attention to. In addition to an event that fortunately results in no harm to the patient, there is a level, PSE3, in which the presence or absence of harm can't be confirmed or determined for various reasons, including the possibility that unintended outcomes happen long after the patient is being cared for or perhaps is lost to follow up for various reasons. These lesser events were identified as fertile soil for organizational learning in the reference book, Safety-I and Safety-II: The Past and Future of Safety Management. Serious Safety Events (SSE), by their nature, are relatively rare, usually complex sequences of events that may never replicate themselves in the future. Whereas PSEs and near-miss events are often instances of less-complex failure sequences that are likely to be repeated in the future, before actually resulting in an outcome that energizes the organization to take action. Capturing, studying, and communicating these lesser events is important.

Precursor Safety Event Classification: Precursor Safety Events (PSE) consist of PSE1 through PSE4 with varying levels of harm caused to the patient. PSE1 causes minor permanent harm, PSE2 causes monitor temporary harm, PSE3 causes no detectable harm, and PSE4 does not cause harm.

The Failure Modes and Effects Analysis (FMEA) Tool by the Institute for Healthcare Improvement (https://www.ihi.org/resources/Pages/Tools/FailureModesandEffectsAnalysisTool.aspx) provided by the facility read, FMEA is a systematic, proactive method for evaluating a process to identify where and how it might fail and to assess the relative impact of different failures, in order to identify the parts of the process that are most in need of change. Teams use FMEA to evaluate processes for possible failures and to prevent them by correcting the processes proactively rather than reacting to adverse events after failures have occurred. This emphasis on prevention may reduce risk of harm to both patients and staff.

The 2023 Quality and Patient Safety Plan (QPSP) read, the Board of Directors (Board) has ultimate responsibility for assuring that high-quality care is provided to the patients. The Board is responsible for review and approval of the QPSP and has charged the Board members of the Quality and Patient Safety Council (QPSC) with primary oversight of the QPSP and communicating quality and patient safety updates to the Board. The Board has delegated the daily operations of the QPSP to the Chief Medical Officer (CMO) and the Quality and Patient Safety Department. Together the CMO, Quality and Patient Safety Department, risk management, clinical leaders, and frontline staff monitor outcomes of performance improvement initiatives and assist with key processes to ensure that actions are consistent.

The QPSC is co-chaired by the CMO and Director of Quality and Patient Safety and has representation from patient safety and quality, risk management, nursing, medical staff, and ambulatory services. Additionally, the QPSC has representation from the Board, executive leadership, and the Patient Family Advisory Council (PFAC). The QPSC functions and responsibilities include oversight of the provision of patient safety metrics, performance improvement initiatives, and patient safety education to employees, physicians, and patients; regularly assessing trends in patient safety, while assisting in the identification of improvement opportunities, prioritization, and problem solving; ensuring data and information reviewed through the QPSC are reviewed and analyzed, and that appropriate improvement initiatives are implemented; providing or eliciting recommendations for appropriate follow-up when patient safety issues are identified, and appointing groups or individuals to ensure timely follow-up occurs; and reviewing and making recommendations to the Board on any matter pertaining to the quality of care, patient safety, patient satisfaction, or culture of safety within the organization.

The facility educates all staff on the importance of reporting safety events upon new hire and regularly thereafter. The facility addresses all concerns that relate to quality of care and patient safety issues within the scope of facility standards, practices, and guidelines. These include issues such as patient rights, care of patients, safety, infection control, medication use, and security.

The facility's primary goal for its quality improvement initiatives is to ensure that every patient served receives optimal care. Throughout the year, certain high-priority conditions and safety concerns will receive special attention as the annual and three-year goals and objectives change. The selection of quality-related goals or priorities is based on an assessment of system-wide gaps in performance, and potential opportunities to benefit a large number of patients.

Effective patient safety and quality improvement is an effort that includes well-planned and executed formal and informal process improvement efforts. Performance improvement is an approach to evaluating and improving processes to continuously improve the care delivery and services to our patients. A multidisciplinary team approach is used to understand current practice, analyze related metrics, and recommend changes to improve patient outcomes.

1. The facility failed to ensure QAPI staff reviewed and analyzed safety events and concerns brought forward by medical staff in order to implement follow-up improvement activities.

A. Safety event report and medical record reviews

i. A review of safety events and medical records revealed patients received physical measures during times of de-escalation, including the use of a Taser (a device that generated electricity to incapacitate the patient), wrist locks (holding someone's wrist and exerting pressure against the joints of the hand), straight armbars (a series of moves designed to control and bring someone down to the ground), and immobilization of the limbs to restrict movement or control. Further medical record review revealed physical holds and hands-on techniques by security officers were not perceived to be methods of restraint and as such, lacked provider orders for restraints and nursing assessments after the incidents. Examples included:

a. A review of Patient #14's medical record for his stay on 5/2/23 revealed the patient had a history of multiple heart conditions, was on supplemental oxygen, and was tased by the security officers while in the ED. Review revealed after the patient was tased, the patient complained of shortness of breath, at which point the nurse measured his oxygen level and pulse rate while on supplemental oxygen. The medical record failed to reveal any other nursing assessment performed after he was tased to ensure no harm had come to the patient from being tased. The medical record review showed the patient was then discharged from the facility.

Patient #14 had one safety event report entered for his stay on 5/2/23, which documented the patient was tased by the security officers while in the ED. The follow-up review, conducted by safety and security manager (Manager) #7, who did not have a medical or clinical background, documented the event was reviewed, she had determined no harm had come to the patient, and staff had followed standard procedures. A second review, conducted by the registered nurse (RN) manager of the ED (Manager) #5, read the event was reviewed. Manager #5 had also determined no harm had come to the patient and to the staff members involved, and security officers had acted appropriately to keep staff members safe. A third review, conducted by the director of safety security and emergency management (Director) #1, who did not have a medical or clinical background, documented the event was reviewed and discussed with the security supervisors and the security officer involved. The follow-up documented Director #1 reviewed the video footage and found there was no apparent harm to the patient beyond the Taser pricks and potential damage from lowering himself onto the floor in a spasm. The review by Director #1 concluded the use of the Taser was justified as Patient #14 had threatened the nursing staff and the security policies, the Continuum of Force, and the Security Officers: Taser Use and Safety, were followed. The safety event review by Director #1 concluded with a statement that no follow-up was required. Further review of the safety report revealed no evidence of a QAPI staff review to ensure patient safety, or to identify and implement any applicable interventions to ensure the continued safety of patients.

The medical record review for Patient #14 was in contrast to the safety event follow-up for this incident, which documented no harm had come to the patient other than being pricked with the taser and being lowered to the floor in a spasm. The safety event review revealed no evidence security, medical, or quality staff identified the lack of ongoing patient assessment after the use of the Taser and Patient #14's report of shortness of breath to ensure the patient was unharmed. Additionally, there was no evidence staff implemented any applicable interventions to ensure the continued safety of patients.

b. A review of Patient #13's medical record revealed on 9/15/23, he was admitted to the facility for treatment of bipolar affective disorder (a mental illness that causes shifts in a person's mood, energy, activity levels, and concentration) and psychosis (collection of symptoms that affect the mind, with a loss of contact with reality). Nursing notes revealed the patient refused psychiatric medications, and verbally and physically threatened staff which led the staff to call 911 for police assistance.

Patient #13 had one safety event report entered on 9/15/23 which revealed the patient refused medication on the behavioral health unit and nursing staff needed help from security officers for medication administration. The event documented the patient began verbally and physically threatening staff at which point the nursing staff called the police for assistance. When police arrived, the police officers tased the patient after attempting other verbal de-escalation procedures.

In the safety event follow-up, Manager #7 documented she had reviewed the event, determined no harm had come to the patient, and that standard procedures were followed. The review by Manager #7 documented the next step would be a critical event analysis (CEA). A second review by RN clinical manager for the inpatient behavioral health unit (Manager) #4 read, she reviewed the event, interviewed staff, and had determined the correct processes were followed.

The review of Patient #13's medical record failed to reveal documentation of the events which took place after the police were called and the patient was tased There was no evidence in the medical record showing that the patient was tased and then received a medical assessment to ensure there was no harm to the patient after he was tased. This lack of documentation was in contrast to the safety event which revealed Manager #7's determination that no harm had come to the patient.

This review of the safety report, medical record, and CEA for Patient #13 failed to reveal if patient safety was identified as a concern when using physical force (a Taser) on a high acuity (a patient with a severe and imminently dangerous condition) psychiatric patient.

c. Medical record review of Patient #6's care on 8/14/23 failed to reveal documentation of security holds or provider orders for these holds, other than the holds performed for the administration of emergency medications (calming medications administered to disruptive patients).

Throughout Patient #6's admission from 8/14/23 to 9/22/23, there were eight safety events with regard to the use of physical holds and other physical means during times of escalation, including transport wrist locks (holding the wrist in a way that prevented movement) and straight arm bars (pulling someone's arm behind their back to control their movements). (Cross-reference A-0154)

d. Medical record review of Patient A's care on 8/8/23 failed to reveal documentation of the physical holds placed by security officers during the associated safety event or evidence that a provider's orders were placed.

Patient A had one safety event on 9/5/23 which documented a palm heel strike and takedown by security officers. (Cross-reference A-0154)

e. Medical record review of Patient E's care on 8/27/23 failed to reveal documentation of the takedown and wrist lock as documented in the associated safety event or provider orders for security holds during this time.

Patient E had one safety event on 8/27/23 which documented a takedown and wrist lock by security officers. (Cross-reference A-0154)

f. Medical record review of Patient I's care on 7/26/23 failed to reveal documentation of the strikes security used as they left the patient's room.

Patient I had one safety event on 7/26/23 which documented a takedown and palm-heel strikes by security officers. (Cross-reference A-0154)

The review of the safety events for Patients #6, A, E, and I revealed Manager #7, a manager in the security department with no medical or clinical backgroudn, had read the events, determined no harm had come to the patients, that security had followed standard procedure, and no follow-up was needed.

The review of safety events and medical records for Patients #6, A, E, and I failed to reveal providers' orders for restraints and nursing assessments conducted after physical interventions implemented by security officers. In addition, there was no evidence of medical or QAPI staff review of the events to ensure patient safety was maintained and to identify and implement any applicable interventions to ensure the continued safety of patients.

ii. Medical record review revealed respiratory therapists (RT) performed intubations (insert a tube into the airway) on multiple patients (Patients B, C, and D) without this being a part of the RTs' scope of practice or having the appropriate staff privileges. (Cross-reference A-1163)

a. A review of Patient B's medical record revealed on 4/25/23, the patient was not oxygenating (getting enough oxygen) and was intubated by an RT.

b. A review of Patient C's medical record revealed on 7/17/22, a code blue was called for the patient, after which an RT intubated the patient.

c. A review of Patient D's medical record revealed on 7/16/22, the patient was found without a pulse. The record revealed the patient was intubated by an RT.

Document review revealed RTs were not privileged to perform intubations however, the facility was not able to provide evidence of ongoing interventions by QAPI staff to ensure RTs were not intubating patients.

iii. A review of the medical records for Patient #1 and #2 revealed Patient #1 gave birth to Patient #2 on 9/9/23. Review revealed Patient #1 was 31 weeks pregnant and presented to the facility with abdominal pain. Patient #1 was diagnosed with placental abruption (a situation in which the placenta, which provided oxygen and nutrients to the baby, separated from the inner wall of the uterus before birth). Patient #2 was delivered and diagnosed with hypovolemia (a condition due to a lack of blood circulating in the body) and respiratory failure (the inability to breathe) and was later transferred to another facility.

Review of the safety events revealed nine safety event reports were entered for Patients #1 and #2, regarding care concerns throughout the care provided during the 9/9/23 visit.

The facility conducted a root cause analysis (RCA), however did not identify a lack of training by the labor and delivery nursing staff as a contributing factor. (Cross reference A-0392).

iv. Further review of safety events revealed non-English speaking patients received treatment without consent and were not provided with interpreters. Examples included:

a. A review of a safety event dated 8/25/23 revealed a Spanish-speaking patient was not given access to an interpreter. The safety event focused on the patient's allergy to tape, which was listed on her allergy list, but still used in her care. The follow-up to the safety event revealed there were no signs an interpreter was used throughout her care except at the time of discharge.

b. A review of a safety event dated 9/5/23 revealed a Spanish-speaking patient received blood in the emergency department (ED) without having consented to the blood transfusion and being aware of his right to refuse. The follow-up to this safety event revealed the patient's medical record was reviewed by an ED manager who determined no harm had come to the patient. At this point, the safety event review was completed.

c. A review of a safety event dated 9/30/23 revealed a Spanish-speaking patient had an endoscopy (a procedure used to visually examine the upper digestive system) and colonoscopy (a procedure used to visually examine the lower digestive system) performed without having access to an interpreter. The follow-up to the safety event revealed education would be provided to care staff.

Further review of the afety event reports for non-English speaking patients revealed no evidence of a QAPI staff review to identify and implement any applicable interventions regarding an on-going patient safety concern to ensure the continued safety of patients.

Upon request, the facility was unable to provide QAPI's plan for the concerns identified in the safety event reports regarding interpreter services.

B. Committee Meeting Minutes and Email review

i. Review of the Quality and Patient Safety Council Agenda meeting minutes from 11/30/22 to 9/20/23 revealed the safety events identified above were not addressed during these meetings.

ii. Review of the Quality Staff meeting minutes from 10/25/22 to 9/26/23 revealed the safety events identified above were not addressed during these meetings.

iii. Review of the Code Blue and Emergency Response Review Committee meeting minutes from August 2022 to August 2023 failed to reveal any discussion of the incidents in which several RTs performed intubations, which was outside of the RTs' scope and facility policies. There was also no evidence code blue events that occurred in the ED were reviewed by this committee.

iv. An email provided by the facility on 10/24/23 at 1:55 p.m., written by regulatory readiness manager (Manager) #18, revealed code blue events in the ED were not reviewed by the quality and risk department unless safety events were created. The email also revealed the facility planned to begin reviewing the code blue events that occurred in the ED at the Code Blue committee at a future, unspecified, date.

E. Interviews

i. An interview was conducted on 10/23/2023 at 10:50 a.m. with registered nurse (RN) patient safety and quality specialist (Specialist) #13. Specialist #13 stated staff entered safety events which he and his team read every weekday. Specialist #13 stated he reviewed and assigned safety event reports to department managers.

Specialist #13 stated it was important to include all specialty areas for safety event reporting as this ensured understanding and buy-in for improving all patient care for the facility. Specialist #13 stated the quality review process started with the department managers and directors who were assigned the safety events to review and to complete a follow-up. He stated these department leaders assigned a rating to each safety event based on the level of patient harm, which was the same rating scale used by the quality department in any follow-up activities or reviews.

Specialist #13 stated department leaders closed out safety events with a rating of PSE3 and PSE4 (PSE3 indicated there was no detectable harm to the patient and PSE4 indicated there was no harm to the patient) and quality did not conduct an addition review of these events due to the large volume of events created at the facility. Specialist #13 stated safety events regarding a lack of interpreters for non English speaking patients were assigned a lower rating by the department managers or directors, which meant they were not tracked and trended by quality.

Specialist #13 stated quality staff had not identified an issue with the L&D nursing staff only being trained in certain areas of the Family Birth Center and lacking competency in others. He stated not having those competencies could potentially have resulted in a lack of coverage for the unit.

Specialist #13 stated the review of inpatient code blue events was conducted by the Code Blue Committee and he would then track the code blue events. He stated ED code blue events were reviewed by the ED manager, not the Code Blue Committee or risk and quality staff, as the system that tracked these events was not set up to capture code blue events that occurred in the ED.

Specialist #13 stated for the incidents in which respiratory therapists had performed intubations, the facility had completed two root cause analyses (RCAs) but the latest incident occurred at a time of leadership change and an RCA was not performed. Specialist #13 stated respiratory therapy leaders were part of the quality reviews and follow-up for safety events that impacted their department. This was in contrast to quality and patient safety meeting minutes which did not reveal the respiratory therapy department's participation.

Specialist #13 stated with the volume of events at the facility, quality and risk reviewed PSE1 and PSE2 safety events (PSE1 events caused minor permanent harm and PSE2 caused minor temporary harm) as these events resulted in patient harm. He stated quality and risk staff tracked and trended these higher-level safety events and reported their results to the Patient Safety Event Committee. Specialist #13 stated trends based on PSE1 and PSE2 events were reported to the Quality and Patient Safety Committee. He stated facility QAPI projects were selected based on known events and national patient safety goals.

Specialist #13 stated the facility did not label, track, or trend PSE3 and PSE4 safety events and there was no separate follow-up process with these events. He stated these types of events would be reviewed if many similar events were seen.

Specialist #13 stated the risk of not identifying issues related to safety events was a safety risk to the patient and a risk that the same incident would recur. He stated it was important to track incidents as this was the only way to improve and identify when something happened in the facility. Specialist #13 stated reviewing and following up on incidents was the best way to improve patient care and to learn from errors.

ii. An interview was conducted on 10/23/23 at 3:59 p.m. and on 10/26/23 at 12:55 p.m. with the director of quality (Director) #12. Director #12 stated she oversaw patient safety, the patient safety department, and the patient services department which encompassed interpreter services, complaints, and grievances. She stated she co-chaired the quality and patient safety meetings, which included governing body (Board) members, and also helped write the quality plan.

Director #12 stated the facility had a system for addressing safety events and she provided oversight to safety event reviews and any following workup. She stated managers and directors in each department ensured a thorough review of each safety event was performed and harm to the patient was assessed so the event could be categorized. Director #12 stated safety events given a rating of PSE3 and PSE4 were closed out by the department managers, rather than quality and risk staff.

Director #12 stated the quality program had adequate staffing to support their current QAPI program and performance improvement activities, but there was not enough staffing or the type of tracking system to perform regular audits, investigations, and follow-ups on PSE3 and PSE4 safety events. Director #12 stated the facility had found an increase in safety events related to interpreter services but a report detailing the investigation into the lack of interpreter concerns was not completed. She stated the quality team only evaluated safety events when department management determined the event caused patient harm, which were then sent on to the quality and patient safety council for review. Director #12 stated it was important to identify, tr

Based on the manner and degree of the standard-level deficiencies referenced to the Condition, it was determined the Condition of Participation §482.23 Nursing Services was out of compliance.

A-0392 The nursing service must have adequate numbers of licensed registered nurses, licensed practical (vocational) nurses, and other personnel to provide nursing care to all patients as needed. There must be supervisory and staff personnel for each department or nursing unit to ensure, when needed, the immediate availability of a registered nurse for care of any patient. Based on interviews and document reviews, the facility failed to ensure registered nursing staff was available to provide nursing care to all labor and delivery (L&D), mother-baby, and neonatal intensive care unit (NICU) patients. Specifically, the facility failed to ensure nursing staff in supervisory roles were adequately trained and had the experience and the competencies to provide patient care.

A-0395 A registered nurse must supervise and evaluate the nursing care for each patient. Based on document review and interviews, the facility failed to provide nursing assessments within recognized standards of practice and in accordance with facility policy in four of four records reviewed for patients placed in a physical hold by security officers (Patients #6, A, E, and I). Additionally, the facility failed to ensure nursing staff provided nursing care and services related to vital sign assessments according to the patient's condition, physician orders, facility policies, and within recognized standards of practice in six of six records reviewed for patients who presented to the emergency department for stabilizing treatment.

Based on interviews and document reviews, the facility failed to ensure registered nursing staff was available to provide nursing care to all labor and delivery (L&D), mother-baby, and neonatal intensive care unit (NICU) patients. Specifically, the facility failed to ensure nursing staff in supervisory roles were adequately trained and had the experience and the competencies to provide patient care in one of six inpatient units.

Findings include:

Facility policy:

The Nurse Staffing Development Plan Policy read, the purpose is to establish guidelines for nursing staffing to ensure continuously safe, high-quality care. The scope is applied to all areas of the hospital in which nursing staff provides care to patients. Nursing staff is available to provide its services 24 hours a day, 7 days a week. The nurse executives identify the nurse staffing needs of the hospital and consider the census, intensity of care, skill mix of nursing staff, level of expert nursing staff, and specialty certification or training of nursing staff.

References:

The Registered Nurse (RN) Clinical Team Lead (CTL) job description read, promoting patient safety is one of the key responsibilities. The CTL is responsible for the department in the absence of the Manager or Director. The CTL is responsible for unit operations when assigned the charge role. The CTL provides appropriate action, follow-through, and closure to any situation affecting the unit in which she/he is involved. Certifications required are based on department registered nurse job descriptions. Employees must have demonstrated the knowledge and skills necessary to provide for the primary population of patients served in the department.

The Family Birth Center Scope of Services 2022 read, assurance of staff competency included the orientation plan, competencies assessed, and methods for identification of staff educational needs. Specific unit-based computer-based orientations (CBOs) are available with the educator or RN manager and all staff are expected to meet annual department competencies. Required certifications are Neonatal Resuscitation Program (NRP), Obstetric Advanced Cardiac Life Support (OB-ACLS), Electronic Fetal Monitoring (EFM), and Basic Life Support (BLS).

1. The facility failed to adequately train clinical team lead staff per facility policy to ensure adequate patient safety.

A. Document Review

i. Review of registered nurse (RN) #20's personnel file revealed she was a CTL in the Family Birth Center and was responsible for the supervision of the L&D, mother-baby, and NICU units. Further review of RN #20's personnel file revealed a lack of evidence of L&D training, competencies, and OB-ACLS certification.

This was in contrast to the RN CTL job description, which read CTLs must have demonstrated the knowledge and skills necessary to provide for the primary population of patients served in the department.

This was also in contrast to the Family Birth Center Scope of Services 2022 which read, all staff were expected to meet annual department competencies. Required certifications for nursing staff included NRP, OB-ACLS, EFM, and BLS.

ii. Review of RN #19's personnel file revealed she was a CTL in the Family Birth Center and was responsible for the supervision of the L&D, mother-baby, and NICU units. Review of RN #19's file revealed a lack of evidence of completed competencies for all three specialty areas. Further review of RN #19's file also revealed a lack of evidence of EFM training and OB-ACLS certification.

B. Interviews

i. On 10/17/23 at 2:09 p.m., an interview with RN #20 was conducted. RN #20 stated she was a night shift CTL for the L&D, mother-baby, and NICU units. RN #20 stated she served as a resource to all units she provided supervision to and was responsible for assisting when emergencies occurred on any of the units she supervised. RN #20 stated she had no past L&D nursing experience, was not trained for L&D, had no orientation to L&D nursing, and had not completed competencies for L&D. RN #20 stated additional staff resources included the provider on call, the unit manager, and the unit director. She stated if additional resources were not available, patients were diverted to other facilities. RN #20 stated when additional nursing staff resources were needed during the night shift (between 7:00 p.m. to 7:00 a.m.), these resources took 45 minutes to an hour to arrive on site, which delayed care.

This was in contrast to the RN CTL job description which read, promoting patient safety was one of the key responsibilities of the position. The CTL provided appropriate action, follow-through, and closure to any situation that affected the unit in which they were involved. Employees must have demonstrated the knowledge and skills necessary to provide for the primary population of patients served in the department.

ii. On 10/19/23 at 1:59 p.m., an interview with RN #19 was conducted. RN #19 stated CTLs within the Family Birth Center were only required to be trained in two of the three specialty units which included L&D, NICU, and mother-baby. RN #19 stated she was the only CTL who provided supervision to the L&D, NICU, and mother-baby units who had experience, training, and competencies in all three areas. RN #19 stated CTLs were expected to have the knowledge to respond to emergency situations in the L&D, NICU, and mother-baby units. RN #19 stated patient safety was the priority and was at risk when a CTL was not trained in a specialty area they supervised. RN #19 stated the house supervisors (ARNs) were additional resources in emergency situations. RN #19 stated ARNs were trained as emergency room (ER) or intensive care unit (ICU) nurses and did not have training, experience, or competencies in L&D, NICU, or postpartum (mother-baby).

This was in contrast with RN #19's personnel file which revealed a lack of evidence of completed competencies for all three specialty areas. Further review of RN #19's file also revealed a lack of evidence of EFM training and OB-ACLS certification.

iii. On 10/19/23 at 12:11 p.m., an interview with the director of nursing (DON) #6 was conducted. DON #6 stated it was important the nurse managers and CTLs understood the duties of the floor nurses and were able to both provide oversight of nursing care in order to take over from floor nurses when it was needed. DON #6 stated advanced clinical knowledge which ensured patient safety was required for the manager and the CTL in the clinical areas they supervised. DON #6 stated it was a requirement of all CTLs to have the skills and training in the specialty areas they supervised.

Based on document review and interviews, the facility failed to provide nursing assessments within recognized standards of practice and in accordance with facility policy in four of four records reviewed for patients placed in a physical hold by security officers (Patients #6, A, E, and I). Additionally, the facility failed to ensure nursing staff provided nursing care and services related to vital sign assessments according to the patient's condition, physician orders, facility policies, and within recognized standards of practice in six of six records reviewed for patients who presented to the emergency department for stabilizing treatment (Patients #7, #8, #9, #10, #11, and #12).

Findings include:

Facility policies:

The Security Officers Continuum of Force policy read, it is the security officer's duty to maintain a controlled and safe environment, especially when dealing with difficult people and situations, using the least restrictive measures possible. The continuum of force is the physical presence of a security officer including the use of multiple security officers or law enforcement officers as backup or a larger show of force. The second step is verbal direction including negotiating to defuse the situation. The third step is soft empty hand techniques including joint locks, pressure points, and strength techniques. The fourth step is hard empty-hand techniques included blocking strikes, defensive counterstrikes, shoulder pin restraint, etc.

The Behavioral Health Patient Care Guidelines policy read, security officers round and are available to assist with care and management of behavioral health (BEH) patients. Notify security for all patients on mental health holds, suicide precautions, or demonstrating aggressive or threatening behaviors. Security officers collaborate with nursing and communicate observations and concerns. Nursing will document as appropriate. For suicidal risk patients, they are placed in a hospital green gown without strings. Patients at risk for self-harm should not remain in personal clothing. If the patient refuses, notify the provider for a physical hold order to remove clothing.

The Nursing Documentation Policy read, the practice of nursing includes the documentation of clinical information and nursing care in the patient's medical record. The standards of clinical practice include the following for documentation specific to nursing. Documents relevant, accurate, and authentic data in a retrievable format. Documents diagnose issues in a manner that facilitates the determination of the expected outcomes and plan. Documents expected outcomes as measurable goals. Documents implementation and any modifications, including changes or omissions of the identified plan. The purpose of documenting clinical information in the patient's medical record includes enhanced visibility of patient trends and responses to interventions. Provides an opportunity for communication, coordination, and collaboration with the healthcare team, including the patient and family. Communicate patients' clinical information, including the patient's medical history, between caregivers to assure continuity of care. Secondary uses of clinical information such as providing quality improvement, workload measurement, revenue recognition, and meeting regulatory requirements.

Emergency Department Patient Care Guidelines policy read, the purpose is to provide patient-centered quality care to all ages with acute, traumatic, life-threatening, or non-urgent conditions consistent with the hospital's mission. Vital signs that are required for all patients within the policy include blood pressure, pulse, respiratory rate, temperature, and pulse oximetry if respiratory complaints are present. Reassessment of vital signs is to be documented every two hours for critical, at-risk patients, and every four hours for all other patients. Critical, unstable, and procedural sedation patients are to be on continuous monitoring with vital signs being imported from the monitoring system into the electronic health record (EHR). Vital signs are also to be performed within one hour of discharge or upon discharge if sedation or narcotics are administered that day.

Reference:

The Human Factor Research Group (HFRG) Threat Pattern Recognition Manual, provided by the facility, read, soft empty-hand techniques are designed to control passive or defensive resistance and include strength techniques such as; joint locks, pressure points, or a knee strike/distraction technique to the subject's thigh (to prevent resistance from the escort position).

Hard empty-hand control techniques are designed to control active aggression and examples include defensive counterstrikes which are defined as techniques that have a probability of injury in the form of bruises, contusions, or lacerations. The HFRG definition for pain compliance is the use of the stimulus pain to control resistive behavior. Once the pain exceeds the subject's pain threshold, the subject usually decides to stop resisting.

1. The facility failed to ensure patients were assessed after they were placed in physical holds by security officers. Specifically, there was a lack of evidence nursing staff assessed patients after security officers implemented arm bars (pulling the patient's arm behind the back to control movement), take-downs (forcing a person to the ground), joint locks (holding the joint in a way that causes discomfort and prevents movement), or heel strikes (using the heel of the hand to forcibly hit a target).

A. Medical record and document review

i. Document review of safety events revealed Patient #6 had eight safety events where she was placed in physical holds by security throughout admission from 8/14/23 to 9/22/23.

a. On 8/18/23 at 3:25 a.m., a safety event report was filed which read, Patient #6's arms were immobilized and she was held in place by a nurse and a security guard. The report read the security officer was asked by the nurse to use a physical hold to return the patient to the seclusion room. Security attempted to implement a transport wrist lock to Patient #6's left arm while the nurse secured her right arm. Patient #6 resisted the transport wrist lock and significant physical effort and repeated verbal redirection were needed for Patient #6 to be successfully escorted to the seclusion room.

b. On 8/26/23 at 8:05 p.m., a safety event was filed which read, nursing requested security assistance for administration of intramuscular (injections administered into the muscle) medications to Patient #6. Security executed a straight arm bar, lowered the patient onto the bed, and held her immobile while medications were administered. The security staff then released the patient who retaliated and security reapplied a straight arm bar, lowered her to the bed, and held her in place.

c. Document review revealed similar findings for six additional safety events for Patient #6, which included additional holds for immobility, joint locks, and escort holds.

ii. Document review of safety events revealed Patient I had three safety events where he was placed in physical holds by security throughout his admission from 7/8/23 to 8/10/23.

a. On 7/26/23 at 12:35 p.m., a safety event was filed which read, Patient I raised his hands and threatened security staff after he was notified court-ordered medications were to be administered. After medications were administered, Patient I was instructed to remain on the floor until staff had exited the room. Patient I did not remain on the floor and was struck by the security officer multiple times with palm-heel strikes.

b. Document review revealed similar findings for two additional safety events for Patient I, which included holds for immobility, joint locks, and holds.

iii. Additional document reviews revealed similar findings of security staff implementing physical interventions during safety events for Patients A and E.

B. Medical Record Review

i. Medical record review revealed on 8/14/23 at 8:41 a.m., Patient #6 was admitted to the facility for treatment of bipolar 1 disorder (a chronic mood disorder that causes intense shifts in mood, energy levels, and behavior). Record review revealed Patient #6 required multiple physical holds, 1:1 monitoring, and seclusion while admitted to the inpatient behavioral health unit. Patient #6's record revealed no evidence of nurse or provider assessment after she was placed in physical holds, arm bars, joint locks, and escort holds by security.

This was in contrast to the Nursing Documentation Policy which read, the standard of nursing documentation included relevant, accurate, and authentic data in a format that could be retrieved. Nurses were expected to document the implementation of any modifications that included changes or omissions of the identified plan. The purpose of documenting clinical information in the patient's medical record included enhanced visibility of patient trends and responses to interventions.

This was also in contrast to the Behavioral Health Patient Care Guidelines policy which read, security officers collaborated with nursing and nursing documented as appropriate.

ii. Medical record review revealed on 7/8/23 at 5:00 a.m., Patient I was admitted to the facility for treatment of schizoaffective disorder, bipolar type (a mental illness that can affect thoughts, mood, and behavior). Record review further revealed Patient I was identified as gravely disabled (when a person, as a result of a mental disorder, is likely to come to serious physical harm or serious illness because the person is unable to provide for their basic physical needs). Patient I was placed in several physical holds by security while admitted to the inpatient behavioral health unit. Patient I's record revealed no evidence of nurse or provider assessment after he was placed in physical holds by security.

iii. Additional medical record reviews revealed similar findings of a lack of assessment after security staff implemented physical interventions for Patients A and E.

C. Interviews

i. On 10/26/23 at 3:36 p.m., an interview was conducted with registered nurse (RN) #26. RN #26 stated a patient assessment after a hands-on interaction with security officers was required due to the risk of patient injury. RN #26 stated she placed an assessment nurse narrative note in the electronic medical record (EMR) of any patient who experienced a physical hold or intervention by security. RN #26 stated she had witnessed security injure patients and when she felt security used too much force, she advised them to reduce their use of force. RN #26 stated the risks of a security officer using physical interventions with patients included musculoskeletal and head injuries, contusions, popped sockets, and broken bones.

ii. On 10/26/23 at 2:01 p.m., an interview was conducted with medical doctor (Physician) #25. Physician #25 stated providers and nurses were expected to assess a patient after security had placed a patient in a physical hold. Physician #25 stated the provider assessment of a patient who had experienced a physical hold or interaction by security included a reassessment of the patient's condition, a discussion with the patient and nurse, and a physical exam when indicated. Physician #25 stated when she performed patient assessments, the assessment was dated, time-stamped, and documented in the patient's EMR. Physician #25 stated the risk to patients if they were not assessed after a physical intervention included missing a significant change in the patient's condition.

2. The facility failed to ensure patients' vital signs were assessed per facility policy and physician orders for patients admitted to the emergency department (ED).

A. Medical Record Review

i. Medical record review revealed Patient #7 presented to the ED on 6/11/23 at 7:31 p.m., with suicidal ideation (a term used to describe a range of contemplations, wishes, and preoccupations with death and suicide), methamphetamine, marijuana, and alcohol abuse. Record review showed vitals were taken only twice; on 6/11/23 at 7:31 p.m. and on 6/12/23 at 1:00 a.m. The triage nurse documented Patient #7's emergency service index (ESI) (triage algorithm that yields rapid, reproducible, and clinically relevant stratification of patients into five groups) level was a two (in a high-risk situation, is disoriented, in severe pain, or vitals are in the danger zone). Patient #7 was discharged on 6/12/23 at 1:38 p.m.

Patient #7 returned to the ED on 6/16/23 at 6:40 p.m., with suicidal ideation, schizoaffective disorder, and bipolar. The triage nurse documented Patient #7's ESI was level two. Vital sign assessments were documented on 6/16/23 at 7:28 p.m., and 6/17/23 at 2:00 a.m. Patient #7 was discharged on 6/17/23 at 9:14 a.m. Documentation revealed no evidence of additional vital sign assessments prior to discharge.

This was in contrast to the Emergency Department Patient Care Guidelines policy which read, Vital signs required for all patients included blood pressure, pulse, respiratory rate, temperature, and pulse oximetry if respiratory complaints are present. Reassessment of vital signs were documented every two hours for critical, at-risk patients, and every four hours for all other patients. Critical, unstable, and procedural sedation patients were continuously monitored with vital signs being imported from the monitoring system into the electronic health record (EHR).

ii. Medical record revealed Patient #8 presented to the ED on 9/1/23 at 4:09 p.m., with fatigue, shortness of breath, diarrhea, weakness, only spoke in two to three-word sentences, and was gray in color. The triage nurse documented Patient #8's ESI was level two. Vital signs were documented at 4:11 p.m. and 4:17 p.m., and documentation revealed no evidence of additional vital sign assessments prior to when a code blue (when someone has gone into cardiac or respiratory arrest) was called at 5:05 p.m. The patient expired at 5:21 p.m.

iii. Medical record review revealed Patient #9 presented to the ED on 9/26/23 at 5:08 p.m., with suicidal ideation. The triage nurse documented Patient #9's ESI level was two. Vital signs were documented on admission at 5:10 p.m. and at 7:49 p.m. Vital signs were next documented on 9/27/23 at 6:30 a.m., and not again until the patient was discharged at 4:50 p.m.

iv. Medical record review revealed Patient #10 presented to the ED on 9/26/23 at 10:32 p.m. for a psychiatric evaluation. The triage nurse documented the patient's ESI level was two. Patient #10's triage vital signs were documented at 10:36 p.m. and showed the patient was tachycardic (the medical term for a heart rate over 100 beats a minute). Vital signs were next documented approximately eight hours later on 9/27/23 at 6:30 a.m., 1:16 p.m., and lastly at 1:58 p.m. Patient #10 was discharged on 9/27/23 at 5:05 p.m.

v. Medical record review revealed Patient #11 presented to the ED on 9/27/23 at 4:34 p.m. for a psychiatric evaluation related to anxiety. The triage nurse documented Patient #11's ESI level as three (multiple resources are needed to stabilize the patient, but vital signs are not in the danger zone). Triage vital signs were documented at 6:33 p.m. Additional vital signs were not documented until approximately seven and a half hours later on 9/28/23 at 1:57 a.m., and upon discharge at 5:31 a.m.

vi. Medical record review revealed Patient #12 presented to the ED on 8/4/23 at 12:29 a.m. with suicidal ideation and was placed on a mental health hold (a medical stay at the hospital or a psychiatric facility in which the person's mental state is evaluated) for a psychiatric evaluation. The triage nurse documented the patient's ESI level as two. Vital signs were documented at 12:40 a.m. and approximately seven hours later upon transfer to a psychiatric facility at 7:37 a.m.

B. Interviews

i. On 10/23/23 at 2:46 p.m., an interview was conducted with RN #14. RN #14 stated vital sign frequency in the ED was determined based on patient assessment, ESI level, and was performed at a minimum of every 30 minutes. RN #14 stated vital signs were performed every 10-15 minutes when a patient was considered to be in critical condition. RN #14 stated vital signs helped the staff assess the stability of the patient and determine if treatments were effective. RN #14 stated the risk to patients when vital signs were not performed was not identifying when the patient's condition changed.

ii. On 10/23/23 at 4:37 p.m., an interview was conducted with RN #15. RN #15 stated vital sign assessment frequency was based on the ESI of the patient. RN #15 stated vital signs were performed every three to five minutes for patients who presented with an ESI level of one, every 15 minutes for patients who presented with an ESI level of two, every 30 minutes for patients who presented with an ESI level of three, and every hour for patients who presented with an ESI level of four. RN #15 stated vital signs were performed once at triage and once before discharge for patients who presented with an ESI level of five. RN #15 explained the initial set of vitals included oxygen level, temperature, heart rate, respiration rate, blood pressure, height, and weight. RN #15 stated heart rate, respiration rate, blood pressure, and oxygen level were rechecked after the initial set of vitals were taken based on patient status. RN #15 explained that psychiatric patients were checked more frequently if they had attempted suicide by overdose or were on suicide watch, otherwise, these patients had vitals done on arrival and every four hours until transfer or discharge.

This was in contrast to the Emergency Department Patient Care Guidelines policy which read, reassessment of vital signs were to be documented every two hours for critical, at-risk patients, and every four hours for all other patients.

iii. On 10/24/23 at 1:09 p.m., an interview was conducted with the emergency department nurse manager (Manager) #5. Manager #5 stated vital signs were an important piece of the patient assessment. Manager #5 stated vital signs in the ED were taken at triage, every four hours while the patient was in the ED, and again when the patient was discharged or transferred. Manager #5 stated when a patient was in critical condition, the frequency of vital signs depended on the stability of the patient and the interventions the patient received. Manager #5 stated the risk to patients when vital signs were not assessed included the missed opportunity to identify an unstable condition and intervene.

iv. On 10/24/23 at 8:48 a.m., an interview was conducted with Physician #16. Physician #16 stated vital signs were an important early indicator of illness in patients and helped determine the patient's treatment course. Physician #16 stated the risk to patients when vital signs were not performed included unidentified early indications of illness.

Based on the manner and degree of the standard-level deficiencies referenced to the Condition, it was determined the Condition of Participation §482.57 Respiratory Services was out of compliance.

A-1163 - Services must only be provided under the orders of a qualified and licensed practitioner who is responsible for the care of the patient, acting within his or her scope of practice under State law, and who is authorized by the hospital's medical staff to order the services in accordance with hospital policies and procedures and State laws. Based on document review and interviews, the facility failed to ensure respiratory services were delivered by a licensed practitioner authorized by the hospital's medical staff in accordance with hospital policies, procedures, and state laws. Specifically, the facility allowed respiratory therapists to intubate patients (insert a tube into the airway) against the facility's policy and procedures in three of three patients reviewed who experienced a code (resuscitation) event.

Based on document review and interviews, the facility failed to ensure respiratory services were delivered by a licensed practitioner authorized by the hospital's medical staff in accordance with hospital policies, procedures, and state laws. Specifically, the facility allowed respiratory therapists to intubate patients (insert a tube into the airway) against the facility's policy and procedures in three of three patients reviewed who experienced a code blue (resuscitation) event. (Patients B, C, and D.)

Findings include:

Facility policy:

According to the Code Blue and Emergency Response policy, staff are trained to recognize and respond to resuscitation emergencies according to where they work, their certifications, and within their scope of practice. If an emergency airway is needed, page anesthesia. If anesthesia is unavailable, the emergency department (ED) provider is the backup.

1. The facility failed to ensure patients who experienced a code blue event were intubated by providers who were privileged, educated, trained, and had the competencies to perform the procedure.

A. Document review

i. Medical record review of nursing documentation revealed on 4/25/23 at 3:10 a.m., a code blue was called for Patient B. At 3:15 a.m., Patient B was extubated (tube removed from airway) by the respiratory therapist (RT). At 3:16 a.m., a new endotracheal tube (ETT) was placed by RT #22. The anesthesiologist who was called to intubate Patient B arrived at 3:18 a.m.

ii. Medical record review of provider documentation for Patient C revealed on 7/17/22 at 8:42 a.m., the provider responded to a code blue event. Patient C was intubated by the RT with anesthesia guidance.

iii. Medical record review of RT documentation for Patient D revealed on 7/16/22 at 4:45 p.m., Patient D was intubated by RT #22. Provider documentation on 7/16/22 at 5:01 p.m. revealed Patient D had experienced a code blue event. Provider documentation also revealed a chest x-ray performed after Patient D was intubated by RT #22 showed the ETT as placed slightly high.

These findings were in contrast to the Code Blue and Emergency Response policy which read, if an emergency airway was needed to page anesthesia. If anesthesia was unavailable, the emergency department (ED) provider was the back-up.

iv. Review of documentation provided by the facility titled, "Medical Staff Roster 10/16/23 Intubation" revealed a list of facility staff privileged to perform intubations. Staff privileged to perform this procedure included the following providers: Anesthesiology, nurse practitioners, general surgery, physician assistants, pulmonologists, neonatal medicine, pediatricians, and emergency medicine providers. Respiratory therapists were not included in this list.

v. Review of email correspondence sent from respiratory manager (Manager) #24 to RT #21 and RT #22 on 4/28/23 at 9:34 a.m. read Manager #24 was proud of how RT #21 and RT #22 managed Patient B's urgent airway needs and she hoped they were proud of the work they did.

vi. Review of email correspondence sent from RT #21 to Manager #24 on 5/1/23 at 7:12 p.m. revealed RT #22 had unsuccessfully attempted to intubate Patient B and was successful on his second attempt.

vii. On 10/26/23 at 9:39 a.m., upon request, the facility was unable to provide evidence of reeducation provided to respiratory therapists related to intubation privileges, or the facility's Code Blue and Emergency Response policy, after the 4/25/23 code event.

viii. Review of email correspondence sent to RT staff from Manager #24 on 9/19/23 at 3:12 p.m. (approximately four and a half months after the code blue event on 4/25/23) read, RTs did not have intubation privileges at the facility. Competencies were not maintained for intubation and it was against hospital policy for RTs to intubate. The administrative registered nurse (ARN) would call the airway pager and follow the pathway to get anesthesia or the ED physician to intubate patients in airway emergencies.

Upon request, the facility was unable to provide evidence respiratory therapy staff had received and read Manager #24's email correspondence from 9/19/23.

B. Interviews

i. An interview was conducted with RT #21 on 10/19/23 at 6:56 a.m. RT #21 stated the training he received for his job as a respiratory therapist included annual competencies for procedures most often performed by respiratory therapists. RT #21 stated training was not mandatory and staff showed up if they could, but were not required to attend. RT #21 stated some of the work he did was spur of the moment and if there was an emergency, he was not concerned if there was a policy or procedure, or if he was permitted by the facility to perform the procedure. RT #21 stated he performed one intubation procedure without a physician's order, which was against hospital procedure, on 7/16/22. RT #21 stated the risk to a patient when an intubation was performed by non-privileged staff included patient harm and death.

ii. An interview was conducted with RT #22 on 10/19/23 at 6:26 a.m. RT #22 stated when he worked night shift, there were several instances where he intubated patients because he felt he had no other options. RT #22 stated since he started at the facility in 2021, he recalled intubating four patients without orders and against hospital procedure. RT #22 recalled two of the intubations he performed were on 7/17/22 and 4/25/23. RT #22 stated the hospital did not have a protocol for respiratory therapy to intubate and therefore he did not know what the hospital standards for intubation were. RT #22 stated he could not recall when the other intubations he performed had occurred and that hospital management was not aware he had performed other intubations. RT #22 stated the risk to patients when intubation was performed by a non-privileged staff included misplacement of the tube into the stomach causing vomiting and aspiration.

iii. An interview was conducted with Manager #24 on 10/17/23 at 11:19 a.m. Manager #24 stated respiratory services performed at the facility were high acuity but low volume and therefore, respiratory therapists were not provided consistent exposure to high-risk procedures like intubation. Manager #24 stated there were no processes that held staff accountable if they did not complete respiratory therapy training and that continued competency training was not mandatory. Manager #24 stated the hospital culture allowed staff to work outside of their privileges and competencies as long as no harm came to patients. Manager #24 stated respiratory therapists did not perform intubations because the hospital did not have the competencies or training for them to do so. Manager #24 stated respiratory therapy staff had intubated patients without the demonstrated competency, policy, training, and protocol to do so. Manager #24 stated the risk to patients when intubation was performed by a non-privileged staff included aspiration, damage to vocal cords, and death.

iv. An interview was conducted with anesthesia medical director (Director) #23 on 10/18/23 at 9:21 a.m. Director #23 stated the facility did not want staff without training or experience to perform intubations and there was no need, or reason, for staff with less experience to intubate. Director #23 stated intubation was not the only way to provide respiratory supportive care. Director #31 stated the facility had an algorithm to follow for intubations and it did not include intubation by respiratory therapists. Director #23 stated he was aware respiratory therapists had intubated in the facility. Additionally, Director #23 stated during intubation, patients were at risk of esophagus (throat) occlusion and swelling which would make subsequent intubations difficult.