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Tag No.: C1004
Based on interview and document review, the facility failed to follow facility policies and procedures to ensure fall risk interventions were implemented and falls with serious injury were thoroughly investigated in a timely manner for 1 of 1 patients (P1) who fell and sustained a hip fracture after a bed alarm intervention was not utilized.
See C-1046.
Tag No.: C1046
Based on interview and document review, the facility failed to follow facility policies and procedures to ensure fall risk interventions were implemented and falls with serious injury were thoroughly investigated in a timely manner for 1 of 1 patients (P1) who fell and sustained a hip fracture after a bed alarm intervention was not utilized.
Findings include:
A Fall Management policy dated 12/2022, directed patients could expect interventions to minimize fall risk and fall related injury, and directed all patients with identified fall/injury risk factors were to receive interventions based on those risk factors or unit standards. The policy designated an Event Reporting policy under Related Documents.
An Event Reporting policy dated 3/2022, identified its purpose was based on a culture of safety which focused on valuing the input of employees and improving the quality of care across the organization and openly discussing patient safety at all levels. The policy identified a Patient Safety Event as an event, incident or condition which may have resulted or did result in patient harm and may have or may not have necessarily resulted from an equipment failure or human error. The policy directed if any device or equipment was involved in the event, it was to be removed from service. In addition, the policy identified there was often an opportune window of time for learning in these events and direct dialogue and communication was strongly encouraged to determine appropriate action. The policy designated a Sentinel Event Policy under Related Documents.
A Sentinel Event Policy, dated 12/2019, identified a purpose to provide a mechanism for identification and investigation of adverse health events as required by Minnesota statute and to outline the process for careful investigation and analysis of safety events which included development of strong corrective actions that provided effective, sustained system improvements to reduce risk and prevent harm. The policy identified a Sentinel Event as one that resulted in death, permanent harm, or severe temporary harm and that such events were called 'sentinel' because they signaled the need for immediate investigation and response. Addendum B of the policy identified a flow sheet of required steps after an event occurred. A basic summary of steps are as follows: designated staff are updated, determination if a root cause analysis (RCA) was required, involved staff interviews were determined, coordinated, and conducted, team meetings were completed after interviews conducted, a decision was made if the event was reportable, patient safety developed an RCA file, a Standard of Care review was completed and they performed a review to understand sequences of events, current process, pertinent policies, and procedural standards, any additional interviews were conducted based on any additional information obtained, a plan was drafted based on compiled information, and then the plan was implemented.
A facility policy related to alarm use was requested; however, none was provided.
A Hester-Davis Fall Prevention Program for Acute Care form undated, identified it was an assessment process that used patient factors that determined fall risk and identified specific fall risk interventions for low, moderate, and high-risk patients. One intervention identified for high risk fall patients was a bed and/or chair alarm.
A Care Plan and Plan of Care policy dated 5/2023, identified a patient's plan of care was found throughout the EHR which included areas such as event and progress notes, clinical documentation flow sheets, education record, and interdisciplinary care plan.
A Facility Reported Incident (FRI) report submitted to the State Agency (SA) on 6/23/23, identified staff heard the chair alarm in P1's room as they approached her door on 6/22/23 around 6:00 a.m. P1 explained she attempted to get up out of bed to use the bathroom (BR) due to "incontinence" and fell. She attempted to grab onto the chair to brace her fall. P1 displayed "some baseline cognitive confusion;" however, thought she may have hit her head on a table. On 6/22/23 at 8:00 a.m. P1 demonstrated a change in condition with right hip pain and increased transfer difficulty. An x-ray was ordered and P1 was transferred to a higher-level care hospital secondary to a hip fracture. The report indicated P1 lacked supervision as "Staff did not have fall alarms on." The report lacked identification the bed alarm was activated by P1's self-transfer out of bed or that staff investigated any deviations in intervention utilization.
P1's EHR identified P1 admitted on 6/20/23 for rehabilitation after a left hip fracture surgery. P1's initial Hester-Davis Fall Assessment completed on 6/20/23 determined P1 to be a moderate fall risk; however, a second assessment later that same day assessed her to be a high fall risk. Initial care planned interventions were put into place: initiate universal fall precautions, place fall risk identification on patient, instruct patient to call staff and wait for assistance, provide patient with education based on risk assessment, place yellow fall precaution signage outside patient door. With second fall risk assessment interventions were added: implement interventions for any risk factor in which patient scores two or greater and to place a red fall precaution sign outside the patient ' s room.
P1's EHR's progress notes identified the following information:
-On 6/21/23 at 6:06 a.m., P1 was alert and oriented, but forgetful. Bed alarms were utilized. P1 was up frequently to the BR during the night. She was educated on hip precautions and ambulating with the walker.
-On 6/21/23 at 2:46 p.m., P1 fell asleep during therapy and was unable to perform more than four repetitions of any exercise without therapist awakening her and getting her back on track.
-On 6/21/23 at 7:01 p.m., P1 was forgetful at times and required "a lot of cueing" for safe transfers in which P1 seemed "unaware of surroundings at times," Alarms were utilized for her safety.
-On 6/22/23, at 6:20 a.m., P1 "had been complaining of excessive urinary frequency. With her confusion and trying to get up we added [urinary frequency medication] last evening. She slept through much of the night but early this morning she tried getting up without calling for help. She fell. She was found on the floor."
-On 6/22/23 at 6:26 a.m., P1 fell when she attempted to use the BR due to incontinence and grabbed onto the chair to brace the fall. When staff entered the room the chair alarm sounded. The note lacked details surrounding the use of the bed alarm and/or any investigation processes related to why the alarm was not sounding when staff entered the room.
-P1's EHR clinical documentation flow sheets identified the following information:
-On 6/21/23 at 1:04 p.m., 4:12 p.m. and 8:03 p.m., P1 displayed short term memory loss, poor judgement, poor safety awareness and was unable to follow commands. At 8:03 p.m. the Bed Exit safety precaution section indicated the bed alarm was "On."
-On 6/21/23 at 9:51 p.m., P1 ambulated to the BR with assist of 1 and the bed alarm was "On."
-On 6/21/23 at 10:40 p.m., P1 ambulated to the BR. Bed alarm section was blank.
-On 6/22/23 at 12:37 a.m., P1 ambulated to the BR. Bed alarm section was blank.
-On 6/22/23 at 2:27 a.m., P1 slept in bed. Bed alarm section was blank.
-On 6/22/23 at 4:55 a.m., P1 slept in bed. The bed alarm was "On."
P1's discharge summary dated 6/22/23, indicated P1 transferred to a higher level of care hospital for evaluation and treatment of a "mildly displaced right intertrochanteric [hip] fracture."
A Fall Event incident report, provided 7/6/23, identified P1's 6/22/23 fall and follow-up actions. The report indicated a Severity Level of Minor Harm and identified P1 self-transferred out of bed and fell when staff were about to enter her room. The chair alarm sounded. A Post Fall Huddle Details section identified a Transfer Technique subsection with an entry "Assistive device used inappropriately/incorrectly." However, the report identified correct interventions were in place prior to the fall. A Witnesses/Involved Parties section identified registered nurse (RN)-B, RN-D, and nursing assistant (NA)-A, along with areas for interview details. All three interview areas remained blank. A Follow-Up Actions section identified RN-C's patient safety follow-up, completed on 6/23/23, adjusted the event to a Serious Safety Event with an RCA "likely" and a Standard of Care to be completed by RN-A as "details surrounding the fall are somewhat unclear," and "When assistance did not arrive, [P1] attempted to get up on her own and slid out of either the better [sic - bed or] chair." RN-A's Supervisor Sign-Off section indicated "During hourly rounds bed alarm started to sound. [P1] found on floor. [P1] attempting to get to bathroom ... Hester Davis Fall risk intervention s [sic] were in place including bed alarm." Follow-up Patient Safety Review indicated plan to make staff interview requests through RN-A "next week Tuesday" after 'move.' A Weekly Event Review section dated 6/27/23, indicated after initial review there were no deviations and thus not considered a safety event; however, the event met Adverse Health Event criteria in which an RCA was to be conducted.
When interviewed on 7/6/23 at 2:22 p.m., licensed practical nurse (LPN)-A stated any patient who was assessed to be a high fall risk and presented with "confusion" or self-transfer attempts was expected to have bed and chair alarms utilized. She explained staff were expected to follow the plan of care and to ensure bed and chair alarms were on and functioned prior to leaving the patients room to keep patients safe. She indicated P1 was confused and had a fall during her stay. LPN-A denied knowledge of any concerns related to the fall. In addition, she denied she was educated on alarm use expectations after P1's fall.
During interview on 7/6/23 at 2:51 p.m., RN-E stated patients were assessed for fall risk using a Hester-Davis Fall Assessment process. The software produced a fall score and provided a list of interventions to select from or a spot for manual intervention entry. RN-E explained there were many identification processes for staff to know alarms were utilized i.e., high fall risk magnet outside the door, care board alarm identification, yellow fall risk wristbands, alarms in place when enter room, EHR alarm flow sheet documentation, information provided during shift change report, etc. When these identification items were in place, staff were expected to make sure alarms were on and functioned when the patient was alone to prevent falls. Failure to ensure this risked injury to the patient as the patient could get up, fall, or staff would be unaware the patient fell until they rounded again. RN-E stated she cared for P1 the morning immediately following the fall out of bed in which she heard P1 may have hit the chair alarm which caused it to sound. She considered P1 a high fall risk and expected P1's alarms were on and functioning after staff cared for her. RN-E denied knowledge of any concerns related to P1's fall or that she initiated any investigation processes into P1's fall. In addition, she denied she was educated on alarm use expectations after P1's fall.
When interviewed on 7/6/23 at 3:28 p.m., RN-A indicated she was the nursing manager and explained alarms were utilized if a patient scored a moderate risk for falls with a two or higher in cognition or mobility or any patient that scored high risk and she expected alarms to be on and functioning if the scoring criteria was met. If not utilized, there was an absolute increased fall risk to the patients as the alarm(s) alerted staff the patient attempted self-mobility. RN-A stated her fall investigation processes involved chart review, involved staff interviews, and education with those staff if issues were discovered. Typically, patient safety staff were not involved, other than to review the incident reports. She explained it was important to interview involved staff in a timely manner as staffs' memories were "fresh" for her to obtain accurate accounts of the events and to provide as needed education to ensure continued patient safety. RN-A initially determined, on 6/22/23, there were no concerns related to P1's fall based on progress note and incident report review in which she identified both alarms were on at the time of the fall. In follow-up, she contacted patient safety staff and discussed the incident as P1 sustained a hip fracture and spoke to staff who worked the shift following the incident to ensure the alarms were on and functioning at that time; however, she did not speak to the nursing staff who worked at the time of the fall as it was determined patient safety staff would interview them. RN-A denied those staff were yet interviewed due to the recent holiday and a unit move which occurred on 6/27/23, and thus, she only knew information identified in the progress notes and the incident report. RN-A and patient safety were scheduled to have their first meeting on 7/6/23 to discuss the next steps so patient safety could perform an RCA.
During interview on 7/6/23 at 5:34 p.m., RN-B explained she approached P1's closed door on 6/22/23 during routine rounds, heard a "thud," and then an alarm. Upon entering P1's room, the chair alarm was positioned on the chair and the alarm sounded; however, the bed alarm was silent. In addition, the call light was not activated despite P1 stating she had gotten up to use the BR. P1 laid on the floor in front of the chair and about five feet from the bed. RN-B confirmed P1 was last observed to be in bed and indicated the nursing assistant never moved P1 out of bed. It appeared as if P1 hit the chair alarm pad with some part of her body when she fell and she was unsure as to why the bed alarm failed to activate when P1 exited the bed. She explained she did not have time to investigate the bed alarm concerns; however, the bed alarm functioned when P1 exited the bed the prior evening. P1 utilized a bed alarm at night as she was a higher fall risk and had moments of confusion. As the bed alarm controls were located at the foot board, P1 could not have turned them off. In addition, the bed alarm required staff to manually engage it and anytime a patient scored a high fall risk alarms were expected to be on and functioning when patients were not directly supervised to decrease the risk of injury. RN-B denied RN-A or patient safety staff spoke to her about the fall and further denied she was educated on alarm use expectations after P1's fall.
When interviewed on 7/7/23 at 10:07 a.m., social worker (SW)-A stated she was approached by RN-F on 6/23/23 to discuss the need to make a vulnerable adult (VA) report to the SA as "not all the alarms were on." She explained if there were a fall with injury there was increased investigation from nursing leadership which she expected would occur within 24-48 hours of the incident; however, she was not typically involved in the investigation process. Timely investigation was important, especially if the patient stayed with them, to decrease the risk of a recurrent concern if one was identified. She denied any further conversations with nursing leadership related to P1's fall after RN-F spoke with her and the VA was filed.
During interview on 7/7/23 at 10:20 a.m., RN-F stated P1 was confused and was a high fall risk, thus, P1 was expected to have alarms utilized. She denied being updated there were any alarm malfunctions of P1's bed and explained that bed was used by a different patient after P1 was discharged and the alarm functioned properly for that patient. However, she explained there was confusion within the fall documentation, and staff conversations, related to P1's fall alarm use and there were "still some unanswered questions" if the alarm was utilized properly. She explained she was a fall committee member and she expected nursing leadership would have investigated this confusion; however, she denied nursing leadership had spoken to her or that the committee had met to discuss the fall. She explained due to the recent unit move, the quarterly fall committee meeting was on hold; however, she was unable to explain the reason as to why the fall committee did not review P1's fall with injury, especially as there was confusion surrounding alarm use.
When interviewed on 7/7/23 at 11:44 a.m., RN-C stated she was a patient safety nurse and was initially involved in P1's fall investigation. She was updated on P1's fall on 6/23/23 (a day after the fall) as the incident report was initially triggered for minor harm which was directed to required staff the next day. After her review, she adjusted the incident to trigger moderate/severe harm for additional staff alerts and quicker investigation follow-up timeframes as the incident "looked like an adverse health event." She instructed RN-A to complete a Standard of Care review which was completed 6/23/23. This review, and additional conversation with RN-A, lacked event concerns other than the fracture. A plan was formulated to initiate staff interviews to assist in the RCA process; however, it was determined to wait until the main region patient safety nurse returned the following week. She confirmed, after review of patient safety notes, staff interviews were not yet completed; however, the regional patient safety nurse was in the process of reaching out to a subject matter expert for further involvement in the process as there was continued event confusion and needed some additional clarification(s) on standards of care. RN-C stated the facility lacked guidelines for expectations related to timing of staff interviews in an investigation process; however, ideally, she would like staff to be interviewed "pretty quickly" as it was important to interview staff as soon as possible, especially if there were concerns related to patient safety and deviations of practice standards.
During interview on 7/7/23 at 12:34 p.m., the director of patient services (DPS) stated she expected all high-risk patients to have all interventions care planned, and utilized, that were triggered by the Hester Davis fall assessment process, unless the intervention could not be implemented i.e., lack of environmental space. She explained all high severity event reports go to herself, RN-A, and the president in which RN-A reviewed the incident and the EHR, analyzed the event, and then updated her on the analysis results. DPS stated patient safety only spoke to RN-A related to the events that surrounded P1's fall and had yet to talk with any of the involved staff as RN-A initially reported no concerns or deviations in care standards and it was determined there was not an immediate need to communicate with or education staff. After DPS was provided with a timeline of P1's EHR and synopsis of fall event details, she stated, in hindsight the information should have triggered staff interviews to determine if there were equipment concerns or inappropriate alarm use to determine timely corrective actions such as staff education and/or equipment replacement and assessment. DPS stated she "would assume the bed alarm malfunctioned or staff did not put the alarm on. Either way, the bed alarm should have gone off."
During a subsequent interview on 7/7/23 around 1:15 p.m., during a guided tour of P1's room on the old unit, RN-A stated she did not interview P1 on 6/22/23, did not enter P1's room to observe P1's room environment, nor did she direct P1's bed to be removed from use pending analysis to ensure it functioned properly after she was updated P1 fell, thus, she was unable to provide additional environmental or alarm details.
When interviewed on 7/7/23 at 2:40 p.m., NA-A stated she was expected to ensure all alarms were on and functioned for high fall risk patients before she left the room to prevent falls and injury. She explained P1 utilized alarms in which she was quite sure she activated the bed alarm after she assisted P1 to the BR around 12:37 a.m. She was unable to recollect assisting P1 with toileting after that, nor assisted P1 to the chair. Around 6:00 a.m. P1's alarm was heard during rounds when RN-B approached P1's room. NA-A stated P1's chair alarm sounded, and she denied the bed alarm was activated. She explained she thought P1 self-transferred from bed and hit the chair alarm with her hand; however, for some reason the bed alarm did not sound when P1 exited the bed. NA-A denied nursing leadership spoke with her related to the fall events and denied she was educated on alarm use expectations after P1's fall.