HospitalInspections.org

Based on interview, review of medical record and event documentation of a patient who sustained repeated falls at the hospital (Patient 1), review of policies and procedures, and review of other documentation, it was determined that the hospital failed to fully develop and enforce policies and procedures that ensured patients' rights were recognized, protected and promoted and all components of an effective abuse and neglect prevention program were evident, including clear and complete investigations of potential abuse or neglect incidents, as defined by CMS, to ensure those incidents did not recur as follows:
* A patient fell from an Xray table while unattended by staff and sustained a hip fracture; and the patient fell another time after climbing or rolling over raised bed rails and the hospital failed to conduct clear and complete investigations of those events, and follow up actions.

The CMS Interpretive Guideline for this requirement at CFR 482.13(c)(3) reflects "Abuse is defined as the willful infliction of injury, unreasonable confinement, intimidation, or punishment, with resulting physical harm, pain, or mental anguish. This includes staff neglect or indifference to infliction of injury or intimidation of one patient by another. Neglect, for the purpose of this requirement, is considered a form of abuse and is defined as the failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness."

Further, the CMS Interpretive Guideline reflects that components necessary for effective abuse protection include, but are not limited to:
o Prevent.
o Identify. The hospital creates and maintains a proactive approach to identify events and occurrences that may constitute or contribute to abuse and neglect.
o Protect. The hospital must protect patients from abuse during investigation of any allegations of abuse or neglect or harassment.
o Investigate. The hospital ensures, in a timely and thorough manner, objective investigation of all allegations of abuse, neglect or mistreatment.
o Report/Respond. The hospital must assure that any incidents of abuse, neglect or harassment are reported and analyzed, and the appropriate corrective, remedial or disciplinary action occurs, in accordance with applicable local, State, or Federal law.

Findings included:

1. a. The P&P titled "NPEOC: Adult Patients in The Emergency Department," dated effective 10/21/2014, was reviewed. It stipulated:
* "Registered Nurses are responsible for following pertinent Nursing Practice Expectations of Care."
* "Reassess relevant variances and on-going treatment plan, upon assuming care of patient through assignment or shift change."
* "Re-assessment includes...Vital signs per Emergency nursing standards and/or nursing judgment..."
* "Assess and adapt individual patient needs on an on-going basis. These include...language, and physical/mental impairment or disabilities."
* "Labs/Diagnostics...RN will accompany patients that are unstable and require diagnostic testing outside of the Emergency Department..."
* "...the nurse identifies individualized expected outcomes for the patient. Expected Outcomes...Safety is maintained during the course of emergency care, without evidence of hospital-associated injury...Pain management plan is effective in maintaining pain [less than] 4 on 0-10 scale or level acceptable to patient..."
* "Continually facilitate communication between patient/family and healthcare team."
* "Activity/Safety...Maintain patient safety on admission and with changes in patient condition (i.e., seizure precautions, fall risks, use of ambulatory assist devices)...side rails in appropriate position for the patient's condition and needs."
* "Evaluation - The nurse evaluates the patient's progress toward attaining expected outcomes and revises the plan of care accordingly."

b. The P&P titled "Safe Patient Mobilization (SPM)," dated effective 01/15/2014, was reviewed and reflected:
* "OHSU will create a culture of Safe Patient Mobilization (SPM) to enhance health care provider and patient safety. Evidence demonstrates that using lift equipment significantly minimizes injuries."
* "Staff are required to use mechanical lift equipment and other approved handling aids...to prevent and/or augment manual lifting and movement of patients when the load is greater than 35 pounds, except when absolutely necessary..."
* "Examples of an urgent lift include the following...A patient has fallen, but clinical assessment indicates that immediate movement is not critical."

c. The P&P titled "Post Patient Fall Assessment & Reflection," dated effective "05/12/2016," was reviewed. It stipulated:
* "This policy describes the process for nurses at all levels being engaged in evaluating nursing practice after a patient falls to identify system, team and individual practitioner strengths and learning opportunities..."
* "The "Responsibilities/Procedure" for the "Clinical RN" reflected "Post-Fall Priorities Begins immediately after the patient falls...Patient Assessment...Assess for injuries, pain, changes in CMS, and strength in all extremities...Obtain vitals signs...Notify Primary team...Re-assess Fall Risk Score post fall (i.e. Hendrich)...Notification to team...Significant Event Notes using format .postfall...Flowsheet: change Hendrich score...Care plan/Handoff Notes: include risks for patient falling, what you learned after the fall from your own reflections, and recommendations to keep patient safe..."
* The "Responsibilities/Procedure" for "Leaders who supervise Clinical RN" reflected "...NM reviews Patient Safety Intelligence [Event] report within 5 working days...reviews primary RN's significant event note in Epic within 5 working days...NM schedules Fall Debrief within 15 working days, and notifies primary RN and interdisciplinary team...NM conducts fall debrief...NM completes the PSI review within 15 working days after the fall...Support primary RN in sharing of learnings on the unit...Sharing of learnings about trends and effective performance improvement across the organization..."
* "As a Practitioner, nurses implement direct and indirect nursing care consistent with evidence-based practices, hospital policies and procedures...They evaluate the plan of care, initiating changes as appropriate...As knowledge Transferors (sic), nurses communicate evaluation of patient's stability, progress, discharge plan and recommendations for continuity of the medical and nursing plan to other members of the health care team, including updating the patient's electronic record."

d. The P&P titled "NPEOC: Inpatient, Adult Acute Care," dated effective 02/02/2017, was reviewed. It stipulated:
* "This is the baseline care offered to every patient on an adult care inpatient unit at OHSU..."
* The "Nursing Practice Expectations of Care" section reflected "...Uses an evidence-based decision-making process to determine the patient's priority goals and care activities in relation to...Documenting decision-making in the patient's plan of care and hand-off communication (care plans, hand off notes, evaluation notes, rounds, shift report observation)..."
* "Vital Signs: HOUR, RR, BP, SpO2, Temp...Prior to Discharge."

e. The P&P titled "Restraint and Seclusion, Use of," dated effective "10/9/2017," was reviewed. It stipulated:
* "OHSU Healthcare strives to create a physical, social, and cultural environment that prevents, reduces and eliminates the need for restraint and seclusion. Restraint and seclusion have the potential to produce serious consequences such as physical and psychological harm, loss of dignity, violation of an individual's rights, and even death. All patients have the right to be free from restraint or seclusion, of any form, imposed as a means of coercion, discipline, convenience..."
* "...The potential negative impact of patients' experience with seclusion and restraint is recognized. OHSU assesses and identifies situations that may lead to the use of seclusion and restraint and provides appropriate alternative interventions. In the event that seclusion or restraint is unavoidable, every effort is made to maintain patient safety and dignity..."
* "...Physical Restraint: 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, or head freely, restricts physical activity, and/or restricts personal freedom of movement...Restraint devices: examples...Use of side rails to prevent a patient from voluntarily getting out of bed constitutes a restraint."

f. The P&P titled "Patient Rights and Responsibilities," dated effective "2/2/2017," was reviewed and reflected:
* "An OHSU patient has the right to...Care that is delivered in a way that is free from abuse...Be free from restraint, unless it is necessary for safety...Receive individualized care that fosters comfort and dignity in a setting free from abuse..."

2. The ED record of Patient 1 was reviewed and reflected the patient presented to the ED on 08/24/2017 at 1237 with a chief complaint of agitated behavior and possible VP shunt malfunction.
* On 08/24/2017 at 1239, ED RN triage notes reflected "Pt brought here by caregiver...Care giver noticed pt with decreased interactions with staff and rigidity to [his/her] posture."
* On 08/24/2017 at 1438, the "Hendrich II Fall Risk" assessment reflected the patient was at risk for falls as follows:
- "...Confusion/Disorientation: Yes;"
- "Depression: Yes;"
- "Altered Elimination: Yes;"
- "Get up and go: Unable to rise without assistance;"
- "Hendrich Score: 12;"
- "Last Known Fall: No falls;"
- "At risk for falls?: yes"
- "Fall Interventions...Bed rails up; Call light; Curtain open; Education for family; Education for patient; Increased rounding; Near nurses station."

* On 08/24/2017 at 1642, ED RN notes reflected "Made ready for Xray..."

* On 08/24/2017 at 1725, the ED physician notes reflected:
- "Patient Summary...[patient] with a [history] of aspergers syndrome...presented to the ED with decreased responsiveness, and less interactions, and is leaning to the left and is less verbal...[He/she] is interactive, increased tone, and right sided hemi-neglect..."
- "ED Course...at about the time of shift change, pt was receiving...xrays and fell from the xray table...reviewed history over past several months (increased spasticity, more withdrawn) and past 1.5 weeks (more notable withdrawn state, non ambulatory, little verbal, more flexion contractures)...Pt is with hips and knees flexed, which [family] says is typical. Possible grimace with hip palpation...discussed the event with the xray technician...xrays and CT imaging reviewed...Right inter-trochanteric [hip fracture] by xray...consulted ortho and family medicine for admission...consider [surgery] of right hip...Will admit..."

* On 08/24/2017 at 1816, a "N-PASS (Neonatal Pain, Agitation, and Sedation)" assessment was documented by the RN and that reflected "N-PASS (Neonatal Pain, Agitation and Sedation) - Sedation Vital Signs (HR, RR, BP, SaO2) (N-PASS): No sedation signs; Sedation Facial Expression (N-PASS): No sedation signs; Sedation Crying/Irritability (N-PASS): No sedation signs; Sedation Behavior State (N-PASS): No sedation signs; (N-PASS): Sedation Score: 0; Sedation Extremities Tone (N-PASS): No sedation signs...awake and alert...RASS Scale: 0."

* On 08/24/2017 at 1828, RN notes reflected "[Patient] was getting an x-ray today and apparently fell off the table. X-ray of [right] hip then showed a fracture line in the proximal femur...Baseline non-verbal, but can answer yes or no to questions at times. [He/she] is also non-ambulatory..."

* The record reflected the patient was admitted to the hospital on 08/25/2017.

During an interview and review of the ED record with the NI on 11/08/2017 at 1040, the NI confirmed the record reflected the following:
* The patient was at risk for falls, and fell from an Xray exam table in DI and sustained a right hip fracture on 08/24/2017. The record contained no interventions to prevent the fall, no DI documentation that described the fall, and no documentation that reflected immediate staff response and actions taken in DI at the time of the fall.
* There was no documentation that reflected the RN notified the primary team (physician or LIP) of the patient's fall as required by the hospital's P&P.
* There was no documentation that reflected the RN assessed the patient's pain until 08/24/2017 at 1815, and that was conducted using a neonatal assessment.
* There was no documentation of an RN ".postfall" significant event note after the fall as required by the hospital's P&P.
* There was no documentation of RN care plan/hand off notes that included learnings and recommendations after the fall as required by the hospital's P&P.

3. During an interview with the NMDI on 11/07/2017 at 1530, the NMDI stated IT staff were expected to "check" patients to ensure they were appropriately positioned on the Xray exam table for their Xray exam, and they used "positioning straps" to aid in accomplishing this. The NMDI stated that IT staff who conducted Xray exams had no way of knowing if an ED patient was at risk for falls.

4. An event Review Form and investigation for Patient 1 was provided in response to a request for the hospital's investigation of the patient's fall and right hip fracture on 08/24/2017. It reflected the following:
* "Event Type Fall"
* "Event occurrence date 08/24/2017"
* "Event occurrence time...17:10"
* "Was the event related to a handover/handoff? No"
* "Event Location...Radiology X-Ray"
* "Event Detail...Patient was on the table on [his/her] back and in fetal [position] and rolled to the left off the table on to the floor. Landing on [his/her] right side."
* "Describe any factors contributing to the event...If we had more people to help hold patient, and don't walk away from your patient no matter what."
* "Was the fall assisted by an employee/member of staff?..Unassisted."
* "Did the patient sustain a physical injury as a result of the fall? Yes"
* "What was the level of injury? Major...What type of injury was sustained?...Fracture"
* "Was a fall risk assessment performed? Unknown/No documentation"
* "Were fall protocols/prevention strategies in place prior to the fall? Unknown/no documentation"
* "Identify any contributing factors at the time of the fall. Select all that apply." This was followed by a blank space.
* "At the time of the fall, was the patient on medication known to increase the risk for fall? Unknown"
* "Prior to the fall, what was the patient doing or trying to do? Undergoing a diagnostic or therapeutic procedure"
* "Does the patient have a history of hearing impairment? Unknown"
* "Does the patient have a history of visual impairment? Unknown"
* "Who was notified?...Nurse"
* "Other Involved Contacts...[name, RT] - after the fact...[name] (student) - witness."
* "Was there a deviation from generally accepted performance standards? No"
* "What were the recommended or initiated actions?..Discussion with staff of unsafe practices...Involved unit staff in problem resolution...Staff orientation process"
* The DI Supervisor "Notes" dated 08/27/2017 at 1143 reflected "Reviewed the event with the involved staff. The patient tolerated the exam and was perfectly still until the last position as the technologist walked to the console to take the exposure."
* The DI Supervisor "Notes" dated 09/01/2017 at 1016 reflected "Will be educating ALL staff of fall risks and what to do in the case of post falls in the September Staff Meeting. We will review this case as well as PSI's submitted in August. Had a meeting on 8/31/17 with [name] to review event."
* The Manager "Contributing factors: Notes" reflected "Recommend asking for assistance with ED team to stay with patient during exam to perform requested study. As (sic) the technologist must walk away from the patient to take the images."
* The "Root Causes" reflected:
- "Communication with patient/family"
- "Orientation & training of staff"
- "Patient observation procedures"
- "Physical assessment process"
- "Physical environment"
* The "Linked event" section reflected "Event occurrence date" 08/24/2017, "Event occurrence time" 1800, and the "Description" reflected "Per Xray staff - Patient went (sic) Xray via WC and was on the Xray table, Xray tech states that [he/she] was laying on [his/her] back and [he/she] stepped away for a moment and patient rolled off the table to [his/her] left and landed in the fetal position on [his/her] right side. No LOC, patient moving after incident."

A draft "Standard Work" document titled "Post Fall Assisted or Unassisted," dated "Last Revised: 14 Sep 2017," was provided and reviewed. Staff present during the document review indicated that the draft document was in response to the fall event involving Patient 1 on 08/24/2017. The document addressed post fall activities such as patient assistance and assessment, ED notification, incident documentation, and notification of supervisor staff. The document did not address potential factors leading to or at the time of the fall.

The event/investigation documentation lacked a clear, thorough and timely investigation and follow up actions. Examples included but were not limited to the following:
* There was no documentation that reflected if IT staff were aware that the patient was identified at risk for falls prior to his/her arrival to DI.
* The information related to the patient's position on the Xray exam table was unclear as it reflected only he/she was "on [his/her] back in fetal position." It was unclear if the patient was positioned in the center of the table or otherwise positioned in a manner that may have contributed to the risk of falling.
* There was no documentation that reflected if positioning straps or other devices were used or not used to aid positioning the patient on the exam table, and if those were appropriate or not appropriate based on the patient's needs.
* There was no documentation that reflected the patient's ability to follow instructions during the exam that may have contributed to the risk of falling.
* There was no documentation that reflected how far the patient fell from the exam table.
* There was no documentation that reflected if the patient hit his/her head.
* There was no documentation that reflected how the patient was moved from the floor after the fall and if the patient was or was not assessed prior to movement.
* The documentation related to staff response to the fall was unclear as it reflected only "Who was notified? Nurse." There was no information related to when the nurse was notified, and if the nurse or other staff responded and assessed the patient, including where that occurred.
* There was no documentation that reflected when or if the physician or other LIP was informed of the fall.
* The documentation reflected DI staff and a student were involved and/or witnessed the event but did not include who positioned the patient on the table and if that individual was qualified and/or trained to conduct those activities.
* The time of the event was unclear as the documentation reflected both an "Event occurrence time" of 1710 and 1800.
* There was no documentation that reflected the event was critically evaluated against hospital P&Ps as applicable, including but not limited to staff monitoring and supervision of patients at risk for falls, communication between departments related to patients at risk for falls, post fall response, post fall assessment, and post fall patient movement.

* The "Contributing factors" reflected "Recommend asking for assistance with ED team to stay with patient during exam to perform requested study. As (sic) the technologist must walk away from the patient to take the images." There was no documentation that reflected if this recommendation was carried out.
* The "Root Causes" reflected "Communication with patient/family...Orientation & training of staff...Patient observation procedures...Physical assessment process...Physical environment." The root causes were general in nature and lacked details that reflected how the root causes were determined and how they were or were not relevant to the event.
* The documentation reflected "What were the recommended or initiated actions?..Discussion with staff of unsafe practices...Staff orientation process" but did not include what the "unsafe practices" were or what was recommended and/or initiated regarding "Staff orientation process."
* The documentation reflected "Will be educating ALL staff of fall risks and what to do in the case of post falls." However, it was unclear who "ALL staff" were (e.g. all DI staff, students, nurse staff, ED staff, etc.).
* There was no documentation that reflected whether abuse or neglect was ruled out.
* There was no further investigation provided that reflected the cause, potential cause and/or contributing factors, and follow up actions.
As a result of the incomplete investigation and follow up actions, there was no assurance similar events involving Patient 1 or other patients would not occur.

5. The inpatient record of Patient 1 reflected the patient was admitted to the hospital on 08/25/2017 at or around 0057.
* The patient underwent a right hip surgery on 08/26/2017.
* The patient's hospitalization was complicated by numerous diagnoses including dysphagia and aspiration pneumonitis.
* The patient remained at risk for falls and the patient's bed rails were raised on numerous occasions. For example, on 09/09/2017 at 1820 and 2012; and on 09/10/2017 at 1610 and 2100, flowsheet documentation reflected "Fall Reduction" with a drop down menu that reflected "2 bed rail (sic) up.
* On 09/11/2017, RN notes reflected "At [approximately] 0230 pt's bed alarm sounded and staff ran to pt's room. Pt was found to (sic) side of bed on stomach on floor. Ceiling lift utilized to get pt back to bed..."
* The first set of vital signs documented after the fall were on 09/11/2017 at 0436, 2 hours after the fall, and those reflected pulse rate 66, respiratory rate 16, blood pressure 111/66 and SpO2 99. No temperature was documented.
* On 09/11/2017 at 0814, flowsheet documentation reflected a Hendrich II Fall Risk assessment was completed and the patient remained at risk for falls.
* The patient was discharged on 09/11/2017 at 1307. No vital signs were documented prior to discharge.
* The physician discharge summary dated 09/11/2017 at 1815 reflected "...patient had a fall from [his/her] bed on 9/11...[His/her] bed rails were up and [he/she] apparently climbed/rolled over them..."

During an interview and review of the inpatient record with the NI on 11/08/2017 at 1200, the NI confirmed the the record reflected the following:
* The patient was at risk for falls and fell from his/her bed after climbing or rolling over side rails on 09/11/2017.
* There was no documentation that vital signs were collected as required by the hospital's P&P. Vital signs were not documented until 2 hours after the fall and those did not include temperature, and no further vital signs were documented prior to discharge.
* There was no documentation that reflected the RN re-assessed the patient's fall risk after the fall as required by the hospital's P&P. A Hendrich II Fall Risk score was not completed until 09/11/2017 at 0814, almost 6 hours after the patient climbed or rolled over raised bed rails and fell.
* There was no documentation that the RN assessed the patient's physical abilities and individualized needs to determine if raised bed rails created a physical restraint for the patient. The record reflected the bed rails were used for "Fall Reduction" but did not include an assessment of whether the bed rails physically restrained the patient who climbed or rolled over them.

6. An event Review Form and investigation for Patient 1 was provided in response to a request for the hospital's investigation of the patient's fall on 09/11/2017. The documentation reflected the following:
* On 09/11/2017 "At [approximately] 0230 pt's bed alarm sounded and staff ran to pt's room. Pt was found to side of bed on stomach on floor. Ceiling lift utilized to get pt back to bed..."
* "Was the fall observed? No"
* "Was the fall assisted by an employee/member of staff?..Unassisted"
* "Did the patient sustain a physical injury as a result of the fall? No"
* "Was the patient determined to be at risk for a fall? Yes"
* "Were fall protocols/prevention strategies in place prior to the fall? Yes"
* "What protocols/interventions were in place, or being used, to prevent falls for this patient?.." reflected:
- "Assistance offered regularly"
- "Bed in low position"
- "Bed or chair alarm"
- "Fall alerts in place"
- "Frequent reassessments (e.g. daily, every shift)"
- "Patient situated close to nurses' station / close observation"
- "Rounds every 1-2 hrs (pain, positioning, toileting, etc.)"
* "Was the patient in restraints at time of fall? No"
* "Identify any contributing factors at the time of the fall Select all that apply" reflected:
- "Altered mental status / cognitive impairment"
- "Unable to rise or ambulate without assistance"
* "Manager Review for Event" reflected:
- "Was there a deviation from generally accepted performance standards? No."
- "What was the remedy or corrective action plan to reduce the likelihood for its recurrence? No action recommended at this time."
- "How preventable was the incident? Likely could have been prevented."
* The section for documenting "Describe any factors contributing to the event, lessons learned, and/or recommendations to prevent recurrence" was blank.
* The NM "Notes" dated 09/11/2017 at 1323 reflected "All safety measures in place. Received antianxiety medication 4 hours prior to fall. [Patient] was toileted and repositioned and (sic) hour before the fall. Bed alarm sounded and staff rushed to room. Patient was found on floor on abdomen. Team notified and xrays completed. Radiology report indicates no injury..."
* The section for documenting "Identify contributing factors to this event" was blank.

The event/investigation documentation lacked a thorough, clear and complete investigation and follow up actions, and did not include details found in the medical record as follows:
* The medical record reflected the patient had a fall from his/her bed on 09/11/2017, the patient's bed rails were raised, and he/she "apparently climbed/rolled over them..." However, there was no documentation in the event/investigation that the patient's bed rails were raised, or that the patient climbed or rolled over them.
* The section for documenting "Identify contributing factors to this event" was not completed and was blank.
* The event/investigation documentation reflected "Was the patient in restraints at time of fall? No." However, it is unclear how this was determined as the event/investigation documentation did not address that the patient "apparently climbed or rolled over" raised bed rails and fell.
* Although the medical record reflected 2 side rails were raised for "Fall Reduction" on numerous occasions prior to the fall, there was no event/investigation documentation that reflected if bed rails were or were not raised at the time of the fall, including if bed rails should or should not have been raised.
* The event/investigation documentation reflected "How preventable was the incident? Likely could have been prevented." However, there was no information that reflected how the incident "likely could have been prevented." Further, the "corrective action plan" reflected "No action recommended at this time."
* Although the event/investigation documentation reflected "Was there a deviation from generally accepted performance standards? No," there was no documentation that reflected the fall was critically evaluated against hospital P&Ps as applicable including but not limited to those related to use of bed rails, physical restraints, post fall assessments, and vital signs.
* There was no further investigation provided that reflected the cause, potential cause and/or contributing factors, and follow up actions.
As a result of the incomplete investigation and lack of follow up actions, there was no assurance similar events involving other patients would not occur.