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MEMORIAL MISSION HOSPITAL AND ASHEVILLE SURGERY CE 509 BILTMORE AVE ASHEVILLE, NC 28801 July 31, 2020
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on policy review, medical record review, and staff interviews, the hospital Interventional Radiology (IR) staff failed to provide care in a safe setting by failing to prevent a fall resulting in a patient injury for 1 of 2 patients (Patient #1) undergoing a procedure.

The findings include:

Review of policy "Facility Event and Close Call Reporting Policy", review/revised date 08/20/2019, revealed " ...Policy: This policy is intended to minimize risk to patients ....through the development and implementation of an event and close call reporting system ... These should be completed as soon as possible after the event, but no later than the end of the shift ... Facility managers .... have 15 business days to complete and document their review and actions. The manager responsible for completion and documentation of final investigation .... Has 60 calendar days to complete and document their final review, actions, and disposition. ..."

Review of policy "Fall Prevention, Risk Screening and Intervention", reviewed/revised date 05/09/2019, revealed "...Policy: (Hospital) will screen patients as appropriate to identify those most at risk for falls and should implement interventions to reduce the risk of injury from falling .... General Information: .... B. When the patient is transported to another area of the hospital, the unit initiating the transport will communicate the patient's fall risk ...."

Closed medical record review for Patient #1 on 07/29/2020, revealed a [AGE]-year-old male admitted on [DATE] with lower extremity weakness and shortness of breath. His medical history was significant for respiratory failure, [DIAGNOSES REDACTED] (brain disease), diabetes, oxygen dependency and overall poor health. Record review revealed the patient's height was 5 foot, 5 inches and weight, 284 pounds. Review of the fall risk assessment revealed a score of 50, indicating the patient was a "Moderate/High" fall risk. The patient's condition deteriorated, requiring intubation (artificial airway) and dialysis. On 12/31/2019, the patient was transported to IR for placement of a vascular catheter (central line used specifically for dialysis), accompanied by an Intensive Care Unit (ICU) nurse at 0830. Review of a nursing progress note by RN #7, on 12/31/2019 at 0900, revealed, "Patient was on IR table for about 20 minutes, I was at bedside, IR staff started procedure, was told to go into control room [anteroom adjoining the procedure room], I hear a loud crash about 2 minutes later. Paged provider [PA] and she came down to IR." Review of a Rapid Response note by RN #9, on 12/31/2019 at 1316 revealed, " ...received call at approx. [approximately] 0900 that pt [patient] had fallen from IR tale [sic] - pt in supine [face up] position cervical collar placed and pt placed on backboard transported to CT and then back to ICU - Provider aware and present." Review of the nursing note by RN #7 at 1000 revealed the patient was transferred back to ICU at 1000 and a skin tear to the left arm was noted. Review of the PA progress note at 1015 revealed, "Patient fell from IR table to the ground. Unclear as to if there was head trauma. CT head and neck without fracture or bleed. On exam of the patient he appeared to have pain in the left should [sic] which improved with ROM [range of motion] examination which raised the question of slight subluxation [dislocation]. Imaging pending." Review of the physician's (MD #1) progress note at 1729 revealed, "Spoke to RN. Patient fell from the IR table to the ground. Imaging of the head and neck were unremarkable for fracture or bleeding. He had ecchymosis (bruising) over his left arm and left shoulder pain. There was a question of possible dislocation. [Left] Shoulder and humerus [long bone of the arm] imaging are unremarkable."

Interview on 07/28/2020 at 1407 with the Assistant Vice President of Cardiovascular Services, Director of IR, Radiology Nurse Manager, and Manager of IR revealed Patient #1 was transferred to the procedure table and arm cradles, used to keep the arms from falling off the table, were placed on both sides of the patient, "for comfort". Interview revealed a safety strap was available but was not used because the staff did not feel the patient was at risk of rolling off the table. Interview revealed the IR scrub technician (SPT #3) had her back turned to the patient, preparing the surgical instruments, the ICU nurse and SPT #1left the procedure room and went into the control room, and the Respiratory Therapist was at the head of the procedure table, turned away from the patient when he fell off the table (approximately 3-4 feet) onto his left shoulder at 0900.

Review of an action plan, developed following analysis of the patient's fall on 12/31/2019, presented by the Manager of IR on 07/31/2020 (213 days post-fall), revealed "Key Issue to Address ... Ensure appropriate safety mechanisms are in place for appropriate patient condition, Have one person within arm's reach of patient at all times while in the procedure room, IR staff unaware of fall risk." Review revealed "Recommendations" included, "Educate all technologists to use straps for patients unable to understand and follow instructions and/or when needed for positioning assistance, IR RN (registered nurse) will be assigned to all invasive procedures in IR, Have IR Navigator (unit coordinator) note falls risk on IR tracking Board for all staff to view ..." Further review of the plan revealed metrics for monitoring and evaluation of the Recommendations included, "Appropriate fall precautions will be implemented 95% of the time, Falls risk will present on the tracking board for 95% of patients ..."

Interview on 07/29/2020 at 0930 with the Director of Accreditation Services revealed the ICU nurse (RN #7) who cared for the patient on 12/31/2019 was not available for interview.

Interview on 07/29/2020 at 1000 with the Manager of IR revealed the patient was accompanied by an ICU nurse and RT to IR. The patient was transferred to the procedure table and his arms were placed in the arm cradles. Interview revealed, "He was an extremely large man and those tables are small, but staff thought he was sedated." The Manager of IR shared that safety straps were available but were not used, "The staff does not routinely use the [safety] strap on the patient if the patient is not moving much." Interview revealed, "This patient initially was not moving. When staff stepped away from the table, the patient suddenly tried to get up and they were unable to reach him before he fell off the table."

Interview on 07/29/2020 at 1110 with Special Procedures Technician (SPT) #1 revealed he was in the control room, with the ICU nurse, when Patient #1 fell from the procedure table in IR on 12/31/2019. The patient was escorted from ICU, with a nurse and respiratory therapist, "unconscious and non-verbal" and transferred onto the procedure table. As standard practice, arm cradles were placed on both sides of the patient, "for comfort". Interview revealed a safety strap was available but "He was sedated to the point of unconsciousness and made no motion until the point of rolling off the table," he said. Interview revealed SPT #1 and the ICU nurse left the procedure room, walked to the control room and heard the patient fall to the floor. Interview revealed the safety strap was typically used for "obese patient's and he [Patient #1] was not large enough to consider using it." SPT #1 shared patient fall risk status is not routinely shared with IR staff and that he was not aware that Patient #1 was a Moderate/High falls risk.

Interview on 07/29/2020 at 1130 with the Respiratory Therapist (RT) revealed he accompanied the patient and ICU nurse to IR on 12/31/2019. "He [Patient #1] had been extubated the day prior (12/29/2019), was morbidly obese and required intermittent BiPAP. We go down to assist in the event the BiPAP is needed for supplemental oxygen when the patient lies flat. He was a big guy and I remember it was difficult getting him onto the table. His arm kept falling off and I walked over and laid his arm back up on him. As I stepped away, moving the BiPAP, I turned and saw him starting to fall and before I could get to him, he was on the floor." Interview revealed that due to the patient's size, the arm cradles "were not effective" and that the safety strap was not used.

Interview on 07/29/2020 at 1150 with SPT #2 revealed he was in the procedure room when Patient #1 fell on [DATE]. "He was unconscious, non-verbal and I thought sedated. We transferred him to the table and prepped for the case." Interview revealed the patient "regained consciousness, picked his torso up, threw his knee over and off he went. (SPT #3) was scrubbing [preparing instruments for the procedure] with her back to the patient. He was a large man and those tables are so small." SPT #2 shared the safety strap was used to prevent patient's from rolling off the table but was not used because the patient was "sedated to the point of unconsciousness." SPT #2 shared patient fall risk status is not routinely shared with IR staff and that he was not aware that Patient #1 was a Moderate/High falls risk.

Interview on 07/29/2020 at 1225 with SPT #3 revealed she was the scrubbing technician and that she was in the procedure room when the patient fell on [DATE]. "The unit nurse and RT arrived with the patient, who was fairly unresponsive and on a BiPAP. We moved him onto the table, and I walked over to prepare the surgical tray. My back was to the table and I heard (SPT #2) yell, 'Oh my God!', when I turned around, he had fallen onto the floor." Interview revealed, "We were busy preparing for the procedure, we thought he was sedated, and turned our backs to him." SPT #3 shared patient fall risk status is not routinely shared with IR staff and that she was not aware that Patient #1 was a Moderate/High falls risk.

Interview on 07/31/2020 at 1115 with the Director of IR and the Director of Quality and Patient Safety revealed a post-fall analysis was conducted on 01/02/2020, with immediate actions taken to prevent patient falls during procedures. Additional "opportunities for improvement" in communicating patient fall risk status were also identified. Interview revealed no audits had been conducted to monitor and analyze effectiveness of the implemented safety measures outlined in the action plan. "We have not conducted any audits to date."
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0175
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of policy and procedures, medical records, and staff interviews, facility staff failed to monitor the condition of a patient in four-point restraints for violent behaviors per policy in 1of 4 sampled emergency department patients prior to final disposition (Patient #7).

The findings include:

Review of the policy "Patient Restraint/Seclusion" effective 01/29/2020 revealed, "PURPOSE: 1. To protect the dignity and safety of inpatients, outpatients, staff and visitors through safe restraint processes. 2. To identify patients at risk for restraint or seclusion and provide alternatives to restraint use ...4. T define the procedure to be followed when all alternatives have been exhausted ...7. Monitoring the Patient in Restraints or Seclusion ...d. A trained staff member monitors each patient in restraint or seclusion at least three (3) times an hour for safety ...This check will be documented in either electronic record or on paper ...f. Monitoring is based on the individual needs of the patient. Variables of the patient's condition, cognitive status, and risks associated with the intervention may require more frequent evaluations ... 12. Documentation Requirements: ...i. Assessment of the patient in restraint or seclusion j. Monitoring of the patient in restraint or seclusion ..."

Review of the medical record revealed Patient #7 was a [AGE]-year-old female who arrived in the emergency department (ED) on 06/14/2020 escorted by law enforcement officers (LEO) under involuntary commitment (IVC) orders after threatening family members. Review of Patient #7's medical record revealed a history of multiple hospital admissions for schizoaffective disorder, Hepatitis C, and illicit substance abuse. On admission, her drug screen indicated recent use of amphetamine, methamphetamine, cannabis, and fentanyl. Review of the medical record revealed, after receiving intramuscular injections of haloperidol (medication used to treat inability to discern real from un-real things) and lorazepam (medication used to reduce feelings of anxiety), Patient #7 was placed in bilateral ankle and wrist restraints for ongoing violent behavior on 06/14/2020 at 1831 per "Restraint Flowsheet" documentation by RN #1. Further review of "Restraint Flowsheet" documentation by RN #1 revealed restraints were discontinued on 06/14/2020 at 1940 (59 minutes later). Further review revealed a "Safety Monitoring Flowsheet" was initiated for Patient #7 on 06/14/2020 at 2214 and continued until an inpatient behavioral health admission on 06/15/2020 at 1758. Record review revealed no restraint monitoring documentation between 1831 and 1940 on 06/14/2020.

Telephone interview on 07/31/2020 at 1545 with RN #1 revealed she had no access to the medical record system and did not recall the events of 06/14/2020 or Patient #7.

Interview on 07/31/2020 at 1310 with RN #2 revealed he recalled Patient #7 and had reviewed the record. Interview revealed Patient #7 had arrived shortly before the end of his day shift and described her as "one of the most ecstatic and violent patients I've seen in a long time." Interview revealed Patient #7 had been escorted into the ED by three instead of typically one LEO, she had been placed in a room across from the nursing station because of agitation, had been medicated, and in bilateral ankle and wrist restraints soon after her arrival. Interview revealed Patient #7 remained in restraints at the time he reported off to the on-coming nurse, RN #1.

Interview on 07/31/2020 at 1210 with RN #3 revealed he had administered haloperidol and lorazepam to Patient #7 and had limited interaction with the patient beyond administering the medication. RN #3 recalled Patient #7 "was using word salad and was not making sense. She would not let us even touch her and would thrash around on the bed if we got near her." RN #3 revealed "once restraints are on it triggers (sends a reminder through the electronic medical record, EMR) for Q1 hour checks ... someone is not required to be in the room. When Doctor (named) put in the order, he put no 1:1 sitter needed."

Interview on 07/31/2020 at 1225 with RN #4 revealed when patients are in bilateral ankle and wrist restraints for violent behavior, monitoring was required at least three times an hour per policy. Interview revealed EMR attestation indicated three times an hour monitoring was done but there was no documentation of Patient #7's condition at the time of the monitoring.

NC 521, NC 901, NC 930