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Based on observation, interview and record review, the Condition of Participation: Staffing and Staffing Responsibilities was not as evidenced by the failure of the CAH to ensure sufficent staff coverage was available at all times and able to respond to emergent events or procedures and to be sufficent to meet the needs of patients demonstrating psychosis or other behavioral symptoms. Findings include:

Refer tp Tag: C-0253

There was a failure of the Critical Access Hospital (CAH) to ensure sufficient staff coverage was available at all times and available to respond to emergent events and to be sufficient to meet the needs of patients demonstrating behavioral symptoms; and the CAH failed to ensure non-hospital personnel cannot be drawn upon for behavior management or care which is the responsibility of the CAH staff in meeting the individuals assessed health needs for 1 of 10 applicable patients. (Patient #1) Findings include:

After threatening staff at a health center, Patient #1 was brought by police to the Emergency Department (ED) on 8/23/18 at 18:00 to be evaluated for acute mental health issues. Patient #1 was determined to be a threat to self and others and was placed on an involuntary status for psychiatric hospitalization. Due to lack of a available psychiatric bed, Patient #1 was initially held in the ED but then transferred to the CAH medical-surgical patient care unit under observation status pending transfer to a psychiatric facility. The initial plan was to start treatment by offering Patient #1 medication to assist in the management of bipolar disorder with psychotic features. Patient #1 refused the prescribed medication to include Depakote (anticonvulsant used to treat bipolar disorders) and Seroquel (antipsychotic). Over the course of 9 days, Patient #1 remained on the medical-surgical unit and nursing staff were able to redirect the patient to remain in his/her hospital room and able to manage Patient #1's intrusive and threatening behaviors. A Clinical Patient Safety Observer (CPSO) was assigned to continuously provide direct one-on-one observation of Patient #1 in order to redirect unsafe patient behaviors. Due to safety concerns, additional monitoring was provided by CAH contracted security (local Caledonia Sheriffs) and when available Sheriffs were also provided by Department of Mental Health (DMH).

On 9/2/18 Patient #1's behaviors escalated, demonstrating an increase in delusions and paranoia with verbal threats to harm staff and especially aggressive to any individual in uniform, to include Sheriffs. At 11:00 PM on 9/2/18 Sheriff #1, contracted through DMH, was assigned to provide a presence outside Patient #1's room on the patient care unit. Sheriff #1 was advised by CAH contracted security officers to stay out of Patient #1's view, due to Patient #1's expressed dislike for individuals in uniforms, specifically Sheriff's. During the late evening of 9/2/18 Patient #1's behavior continued to escalate and s/he became more intrusive with movement in and outside assigned hospital room. As a result, the night nursing supervisor notified the attending physician for Patient #1's reporting concerns regarding increased paranoia and agitated behaviors. A physician's order was received for the application of physical restraints and involuntary medication administration due to concern for the physical safety of staff and other hospitalized patients. Once the physician's order was received the night nursing supervisor called a "Code Gray" (requesting immediate assistance from assigned CAH staff to assist with a safety or behavioral situation/event). Additional hospital staff arrived on the patient care unit to include 2 contracted security guards employed by the CAH, who are Caledonia County Sheriffs. A staff huddle transpired and a plan was formulated by the nursing supervisor which included the application of restraints to a stretcher; transporting the stretcher to Patient #1's room; with staff assistance position Patient #1 on stretcher; apply 4-point restraints and safely administered behavioral medication. Per telephone interview on 9/18/18 at 9:00 AM, Sheriff #1 confirmed s/he saw a group of nurses pull out a restraint bed and was then informed by the nursing supervisor of the intention to restrain Patient #1, however Sheriff #1 had not been included in the initial Code Gray plan. Sheriff #1, although not employed or trained by CAH, choose to become involved with the emergency procedure and entered Patient #1's room with the nursing supervisor. Upon seeing the uniformed Sheriff approaching with the nursing supervisor into his/her hospital room and staff moving a stretcher with attached restraints, Patient #1 became defensive and lunged towards Sheriff #1, hitting the Sheriff in the head, resulting in both individuals falling to the floor. Sheriff #1 confirmed s/he was able to return punches, hitting the left side of Patient #1's face.

Once on the floor, Patient #1 remained on top of Sheriff #1 despite other staff attempting to remove the patient off Sheriff #1. The 2 CAH security guards/County Sheriffs also became involved in the behavioral management of Patient #1. Security guard/Sheriff #2 confirmed on 9/18/18 at 12:00 s/he was able to "...deliver strikes with his/her baton.." onto Patient #1 when attempting to intervene between the patient and Sheriff #1. When Patient #1 was attempting to reach Sheriff #1's service revolver, security guard (Sheriff #3) deployed his/her tazer hitting Patient #1 in close proximity, landing 2 tazer darts into the patient's upper torso. After being tazed, Patient #1 was extracted off of Sheriff #1, hand cuffed by the sheriffs, and with staff assistance was then placed on the stretcher, handcuffs were removed and restraints were applied to Patient #1's arms and legs. Involuntary emergency medication was administered to include Haldol (antipsychotic) 5 mg. IM (intramuscular) and Ativan (sedative) 1 mg IM. Eventually, Patient #1 became less agitated, and remained in restraints for several hours. Patient #1 sustained an abrasion to right eyebrow and redness to left and right flank was observed by nursing staff on 9/3/18 at 8:00 AM. On 9/4/18, Patient #1 was transferred to a psychiatric hospital.

Per CAH policy Behavioral Health Patient-Management of the Admitted approved 7/19/18 states: "All patients presenting with a Behavioral Health concern will be cared for in the same manner as all other patients presenting for care. The behavioral concerns can include poor impulse control, a low frustration tolerance, difficulty in communicating needs, and an inability to think clearly." Patient #1 demonstrated all characteristics as described. It was evident that the event on 9/3/18 represented a failure of the CAH to have sufficient and knowledgeable staff made available at all times to provide the necessary interventions during a behavioral emergent event The use of non-hospital staff for behavioral management resulted in both the patient and staff being subjected to potential safety hazards and injury.

Based on staff interview and record review, the CAH failed to ensure that care was provided in accordance with written policies and procedures regarding the use of mechanical restraints for 1 out of 10 applicable patients (Patient #2). There was also a failure to develop policies and procedures to direct the role and responsibilities of contracted security utilized by the CAH. Findings include:

1. On 08/03/2018, Patient #2 was brought to the Emergency Department with a chief complaint of a psychiatric problem and presented with agitation, hallucinations and paranoia. A mental health evaluation was conducted which determined that Patient #2 met criteria for inpatient psychiatric hospitalization. Due to a lack of an available psychiatric bed, Patient #2 was transferred to the medical-surgical floor of the CAH until transfer from the CAH on 08/08/2018. Per Physician order, Patient #2 was placed under constant observation by a Clinical Patient Safety Observer (CPSO) to maintain safety. During the first 24 hours period following Patient #2's transfer to the medical-surgical floor, staff placed Patient #2 in mechanical restraints.

At approximately 5:52 PM on 08/03/2018, Patient #2 began demonstrating an increase in agitation and aggressive behavior. Nursing staff and Security attempted to verbally redirect Patient #2 when s/he exited their room and, "bolted" to the elevators in an attempt to leave the hospital floor. Per Nursing Progress note, "This RN kept pace with the patient and was trying to calmly talk this patient into going back" to their room. When additional staff responded to the area for assistance, Patient #2, "became hostile", "grabbed" at staff, starting fighting, and screamed threats that they would kill staff members present. Per Nursing Progress note, Patient #2 was placed in restraints at 6:10 PM. Patient #2, "fought against the restraints" and continued to scream and, "fight the restraints" requiring emergent does of Benadryl 25 mg, Haldol 5mg, and Ativan 3mg given intramuscularly in order to manage self-injurious behavior while restrained. Per documentation by Licensed Nursing Assistant (LNA), Patient #2, "appears to be asleep in restraints" at 11:12 PM.

The CAH policy, "Restraints and Management of a Restraint-Free Environment" (approved 07/05/2018) states, "Chemical and/or physical restraints may be needed in severe cases once all other options are exhausted. The judicious use of restraints may need to be considered when it is perceived that imminent danger may occur to self or others...to ensure safety. When restraint is necessary, the patient should be treated with humane care that preserves human dignity." Following the application of restraints with Patient #2 on 08/03/2018 there were documented periods when Patient #2 was calm and/or asleep demonstrating s/he was no longer posing an immediate threat to staff or their own safety. Between 11:30 PM and 3:00 AM on 08/04/2018, Patient #2 was documented to be, "asleep", "lying quietly in bed, and "sleeping" when observed by Registered Nurses and Licensed Nursing Assistants. There was no documented evidence of attempt to begin to discontinue the restraints, and no documented evidence of imminent danger requiring continued restraints to ensure safety. The Vice President Of Quality Management Programs and Clinical Informatics RN confirmed Patient #2's documented calm behavior while restrained at 1:40 PM on 9/18/2018.

During a review of the policy, "Restraints", the VP of Quality Management Programs confirmed that the CAH policy did not include instructions for staff to remove restraints when discharge criteria were demonstrated by patients. S/he confirmed the lack of policy interventions to guide staff with the discontinuation of restraints when risk of imminent harm was no longer present at 2:00 PM on 9/18/2018. In addition, upon review of recent behavioral interventions which occurred on 9/3/18 during which time contracted security staff (Caledonia Sheriffs) had become involved with the behavioral management of a patient, it was further confirmed the CAH had not developed a policy and procedure to direct this contracted service/staff and to further stipulate the prevention of Sheriff's utilizing weapons on patients not in police custody.

Refer to C-253

The Condition of Participation: Periodic Evaluation and Quality Assurance Review was not met based on staff interview and record review the CAH failed to evaluate the quality and appropriateness of treatment and services, in a timely manner, and develop corrective actions as the result of an adverse patient event. Findings include:

There was a failure to identify opportunities for improvement to include the failure to ensure sufficient staff coverage was available at all times and available to respond to emergent events and to be sufficient to meet the needs of patients demonstrating behavioral symptoms; and the CAH failed to ensure non-hospital personnel cannot be drawn upon for behavior management or care which is the responsibility of the CAH staff in meeting the individuals assessed health needs.

Refer to C-253

Based on staff interview and record review, there was a failure to identify opportunities for improvement to include the failure to ensure sufficient staff coverage was available at all times and available to respond to emergent events and to be sufficient to meet the needs of patients demonstrating behavioral symptoms and the failure to ensure non-hospital personnel cannot be drawn upon for behavior management or care which is the responsibility of the CAH staff in meeting the individuals assessed health needs. Findings include:

On 9/2/18 Patient #1, with a diagnosis of bipolar/mania, was held involuntarily on the medical-surgical unit while awaiting placement in a psychiatric hospital. During the late evening of 9/2/18, Patient #1's symptoms of paranoia and delusions escalated and the patient made increased verbal threats to harm staff. At 11:00 PM on 9/2/18 Sheriff #1, contracted through DMH, was assigned to provide a presence outside Patient #1's room on the medical-surgical unit. Sheriff #1 was advised by CAH contracted security officers to stay out of Patient #1's view, due to Patient #1's expressed dislike for individuals in uniforms, specifically Sheriff's. As a result of increased symptoms and wandering in and out of hospital room, the night nursing supervisor notified the attending physician for the patient and received a physician orders for the application of physical restraints and involuntary medication administration due to concern for the safety and risk of harm to staff and other hospitalized patients. Once the physician's order was received the night nursing supervisor called a "Code Gray" (requesting immediate assistance from assigned CAH staff to assist with a safety or behavioral situation/event). Additional hospital staff arrived on the patient care unit to include 2 contracted security guards employed by the CAH, who are Caledonia County Sheriffs. A staff huddle transpired and a plan was formulated by the nursing supervisor which included the application of restraints to a stretcher; transporting the stretcher to Patient #1's room; with staff assistance position Patient #1 on stretcher; apply 4-point restraints and safely administered behavioral medication. Per telephone interview on 9/18/18 at 9:00 AM, Sheriff #1 confirmed s/he saw a group of nurses pull out a restraint bed and was then informed by the nursing supervisor of the intention to restrain Patient #1, however Sheriff #1 had not been directly included in the Code Gray plan. Sheriff #1, although not employed or trained by CAH, choose to become involved with the emergency procedure and entered Patient #1's room with the nursing supervisor. Upon seeing the uniformed Sheriff approaching with the nursing supervisor into his/her hospital room and staff moving a stretcher with attached restraints, Patient #1 became defensive and lunged towards Sheriff #1, hitting the Sheriff in the head, resulting in both individuals falling to the floor. Sheriff #1 confirmed s/he was able to return punches, hitting the left side of Patient #1's face.

Once on the floor, Patient #1 remained on top of Sheriff #1 despite other staff attempting to remove the patient off Sheriff #1. The 2 CAH security guards/County Sheriffs also became involved in the behavioral management of Patient #1. Security guard/Sheriff #2 confirmed on 9/18/18 at 12:00 s/he was able to "...deliver strikes with his/her baton.." onto Patient #1 when attempting to intervene between the patient and Sheriff #1. When Patient #1 was attempting to reach Sheriff #1's service revolver, security guard (Sheriff #3) deployed his/her tazer hitting Patient #1 in close proximity, landing 2 tazer darts into the patient's upper back torso. After being tazed, Patient #1 was extracted off of Sheriff #1, hand cuffed by the sheriffs, and with staff assistance was then placed on the stretcher, handcuffs were removed and restraints were applied to Patient #1's arms and legs. Involuntary emergency medication was administered to include Haldol (antipsychotic) 5 mg. IM (intramuscular) and Ativan (sedative) 1 mg IM. Eventually, Patient #1 became less agitated, and remained in restraints for several hours. The patient sustained bruising of face and upper torso. On 9/4/18 the patient was discharged to a psychiatric hospital.

After the event on 9/3/18 a staff member completed a adverse event report via the Risk Management Reporting System. However, as of 9/18/18 there has not been a formal review of the significant chain of events to include the use of a tazer by contracted security on a hospitalized patient; the seriousness of the altercation that pursued; the effective use of the the Code Gray team; and the lack of psychiatric consultation and direction to staff to assist in the management of the patient's behavioral symptoms. Per interview on 9/18/18 at 11:00 AM, the Chief Nursing Officer confirmed awareness of the events on 9/3/18 and confirmed informal conversations with the VP of Quality Management Program had occurred. There has not been a formal review to evaluate the quality and appropriateness of the treatment and services provided to Patient #1 on 9/3/18. This was further confirmed by the VP of Quality Management on the afternoon of 9/18/18, acknowledging a failure to examine and review all the circumstances which had occurred on 9/3/18 and to identify preliminary opportunities for improvement especially associated with the use of non-hospital employees during behavioral interventions and the use of weapons on hospitalized patients who are not in police custody.