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Based on a review of facility policies and procedures, medical records, a facility incident log, and staff interviews, it was determined that the facility failed to ensure that patient's rights were promoted and protected and that care was received in a safe setting when two patients (P) (P#1, and P#4) of four patients (P#1, P#2, P#3, P#4) sampled were not monitored and assessed while in restraints. Specifically, the facility failed to:

1. Provide a current documented restraint order for a patient while in restraints. This affected one patient (P#1) of four sampled patients.

2. Monitor and document restraint assessments on patients in non-violent restraints at two-hour intervals. This affected two (P#1 and P#4) of four sampled patients.

3. Assist and monitor a patient on fall-risk precautions. The facility's failure to follow protocol resulted in the patient falling and sustaining a wrist fracture. This affected one patient (P#1) out of four sampled patients.

Findings Included:

Cross refer to A-0144 as it relates to the failure of the facility to ensure care was received in a safe setting when facility fall-risk protocol was not followed and P#1 fell and sustained an injury.

Cross refer to A-0175 as it relates to the failure of the facility to maintain active restraint orders for restrained patients and failure to ensure that restrained patients were monitored at intervals of two hours as per the facility's policy.

Based on a review of facility policies and procedures, medical records, facility incident log, and staff interviews, it was determined that the facility failed to reasonably prevent one patient (P) (P#1) of four patients (P#2, P#3, and P#4) sampled from encountering a fall and sustaining a wrist fracture.

Findings Included:

A review of the facility's policy titled "Falls Prevention and Management," effective 2/16/22, revealed that the policy's purpose was to provide identification and ongoing assessment of patients who are at risk of falling. It also would provide resources for staff to implement fall safety interventions and educate patients/families about fall prevention.

Roles/Responsibility:
Registered Nurse (RN)
1.Conducts and documents fall risk factors on admission, every shift, transfer, when there is a change in patient condition, change in level of care, and after a fall occurs.
2.Ensures appropriate fall prevention interventions are implemented based on fall risk assessment and each patient's individualized clinical needs.
3.Educate patient/family about fall risk factors and prevention strategies.
Patient Assessment of Fall Risk for the Inpatient Patient Population:

All patients will be assessed for risk using the Hester-Davis Scale (HDS):
o Upon any admission and every shift.
o When there is a change in the patient's condition and/or level of care.
o Prior to discharge.
o After a patient falls.

Hester-Davis Scale:

1. Age: Score:

< 20 years = 0
20-40 years = 1
41-60 years = 2
> 60 years = 3

2. Last Known Fall No Falls = 0
Within the Last Year = 1
Within the Last Six Months = 2
Within the Last Month = 3
During the Current Hospitalization = 15

3. Mobility No Limitations = 0
Dizziness/Generalized Weakness = 1
Immobilized/Requires assist of 1 person = 2
Use of Assistive Device/Requires assist of 2 people = 3
Hemiplegia, Paraplegia, Quadriplegia = 4

4. Medication No Meds = 0
CV or CNS meds = 1
CV and CNS meds = 2
Diuretics = 3
Chemotherapy in the last month = 4

5. Mental - Status/LOC/Awareness
Alert, Awake, & Oriented to Person, Place, & Time = 0
Oriented to Person and Place = 1
Lethargic/Oriented to Person Only = 2
Memory Loss/Confusion and requires reorienting = 3
Unresponsive/Noncompliance with instruction = 4

6. Toileting Needs No Needs = 0
Use of Catheters or Diversion Devices = 1
Use of Assistive Device (BSC, bedpan, urinal) = 2
Incontinence = 3
Diarrhea/Frequency/Urgency = 4

7. Volume/Electrolyte Status No Needs = 0
NPO > 24 Hours = 1
Use of IV fluids/tube feeds = 2
Nausea/Vomiting = 3
Low blood sugar/Electrolyte Imbalance = 4

8. Communication/Sensory No deficits = 0
Visual (glasses)/Hearing deficit = 1
Non-English speaking/unable to speak/slurred speech = 2
Neuropathy = 3
Blindness or recent visual change = 4

9. Behavior Appropriate Behavior = 0
Depression/Anxiety = 1
Behavioral noncompliance with instruction = 2
ETOH/Substance Abuse = 3
Impulsiveness = 4

Prevention:
The HDS classifies fall risk as low, moderate, or high and identifies minimal required and patient-specific (PS) interventions as follows:

All patients are placed on Universal Fall Precautions (UFPs):
o Ensure call light and belongings are within reach.
o Educate to call for assistance.
o Educate on the level of risk to fall and the purpose of UFPs.
o Ensure the bed is in the lowest position and locked. Side rails should be up x 2.
o Ensure all wheelchairs and chair wheels are locked.
o Keep bathroom and closet doors closed when not in use.
o Ensure the room is well-lit.
o Provide a clutter-free and spill-free environment.
o Assistive devices (i.e., walker, wheelchair) are within reach.
o Use of footwear
o Use non-skid footwear unless the patient has a shuffling gait.

Interventions:

Score Risk Interventions
7-10 Low
1. Initiate UFPs.
2. Individualize Hester Davis (HD) Fall Care Plan.
3. Place a fall risk ID band on the patient.
4. Provide patient/family education based on risk assessment using the HDS.
5. Instruct patient/family to call staff for assistance when getting out of bed or accessing out-of-reach items.
6. Place a GREEN Low Fall Precaution sign outside the patient's door.
7. Do not leave patients unattended while toileting or in the bathroom.

Score Risk Interventions
11-14 Moderate
1. Initiate UFPs.
2. Individualize the HD Fall Care Plan.
3. Place a fall risk ID band on the patient.
4. Provide patient/family education based on risk assessment using the HDS.
5. Instruct patient/family to call staff for assistance when getting out of bed or accessing out-of-reach items.
6. Place a YELLOW Moderate Fall Precaution sign outside the patient's door.
7. Do not leave patients unattended while toileting or in the bathroom.
8. Place the patient in a room close to the nursing station if available.
9. For patients scoring 2 or greater on MOBILITY or MENTALSTATUS/LOC Awareness sections:
a. Turn on bed/chair alarm. Assure alarms are connected to the call light system.
b. Place, if available, fall floor mats on one or both sides of the bed or in front of the chair when out of bed.

Score Risk Interventions
15 or Greater High
1. Initiate UFPs.
2. Individualize HD all Care Plans.
3. Place a fall risk ID band on the patient.
4. Provide patient/family education based on risk assessment using the HDS.
5. Instruct patient/family to call staff for assistance when getting out of bed or accessing out-of-reach items.
6. Place a RED High Fall Precaution sign outside the patient's door.
7. Do not leave patients unattended while toileting or in the bathroom.
8. Place the patient in a room close to the nursing station if available.
9. Place the alarm on the bed/chair; ensure the alarm is connected to the call light if possible.
10. Place, if available, fall floor mats on one or both sides of a bed or in front of a chair when out of bed.


A review of the facility's policy titled "Patient's Rights and Responsibilities," effective 9/18/21, revealed that the policy's purpose was to establish guidelines for patient care that recognize each patient as an individual with unique healthcare needs, values, and cultural perspectives. The policy also aimed to respect, promote, and protect each individual's basic human rights.

POLICY STATEMENT:
Emory Healthcare respects the rights of the patient and focuses on each patient's personal dignity while providing considerate, respectful care focused on the patient's individual care needs. The hospital prohibits discrimination based on age, race, ethnicity, religion, culture, cultural beliefs, personal values, language, physical or mental disability, socioeconomic status, gender, sexual orientation, gender identity or expression, or payment source.
All patients at the facility were entitled to the rights listed below:
o Expect care to be given in an environment free from neglect, exploitation, and verbal, mental, physical, and sexual abuse.

A review of P#1's medical record revealed P#1 was admitted to the facility on 10/17/24 for ongoing confusion and delirium.

A review of the medical record revealed that P#1 had a past medical history of fibromyalgia (a chronic condition that causes widespread pain and tenderness in the body, along with fatigue and sleep issues), lupus (a chronic autoimmune disease that occurs when the body's immune system attacks healthy tissues and organs), rheumatoid arthritis (RA) (a chronic autoimmune disease that causes pain, swelling, and stiffness in the joints), chronic pain, deep vein thrombosis (DVT) (a blood clot that forms in a deep vein, usually in the leg), falls and chronic kidney disease (CKD) (a long-term condition that occurs when the kidneys are damaged and can't filter waste and fluid from the blood properly).

A review of "Clinical Notes," dated 10/21/24, revealed that P#1 required hands-on assistance with functional tasks and that P#1 was at an increased risk for falls.

A review of "Clinical Notes," dated 11/2/24 at 12:15 a.m., revealed that RN AA assisted P#1 to the bathroom and placed her on the toilet seat. RN AA stepped out of the bathroom per p#1's request. RN AA instructed P#1 not to get up by herself. RN AA was making and fixing P#1's bed and heard a sound from the bathroom. P#1 was observed lying on the floor. P#1 stated that she fell on her left side, hitting her hip, arm, and head. P#1 explained that she leaned forward on the seat to clean herself, got dizzy, and fell. A staff member assisted in getting P#1 back into bed. An assessment of P#1 was done and documented. No visible bruises were noted on her body. P#1 complained of pain in her left wrist. RN AA notified the charge nurse and provider.

A review of "Progress Note," dated 11/2/24 at 2:00 a.m., revealed that nursing staff reported that P#1 fell on her left side around 10:25 p.m. on 11/21/24 and complained of left wrist, shoulder, hip, and head pain.
Continued review revealed that P#1 reported she was in the restroom and became lightheaded, fell on her left side, and hit her head on the bathroom floor. The nurse reported P#1 had received Klonopin (produces a calming effect on the brain and nerves), Seroquel (an antipsychotic medication that treats several kinds of mental health conditions including schizophrenia and bipolar disorder), and Ramelteon (used to treat insomnia) prior to her fall.

Further review of the physical exam revealed that P#1 was drowsy. The head, eyes, ears, nose, and throat (HENT) exam revealed left tenderness to palpation to the posterior head. Continued review of P#1's musculoskeletal exam revealed severe left wrist tenderness to palpation and pain with range of motion (ROM). Mild left shoulder tenderness to palpation. Mild left hip tenderness to palpation was noted.

A review of "Clinical Notes," dated 11/2/24 at 2:40 a.m., revealed that P#1's left arm was placed in a sling per the provider to limit wrist mobility.

An urgent computed tomography (CT) scan with contrast (using a special dye to help make certain body parts appear more clearly in the scan) was ordered for the left wrist, hip, left shoulder, and head.

A continued review of CT results revealed an acute mildly displaced impacted fracture of the left distal radial metaphysis (a type of wrist injury that usually occurs after a fall on an outstretched arm) and a cortical irregularity (abnormalities in the outer shell (cortex) of a bone) along the distal ulna, which may represent an additional fracture lucency (a thin, dark line or transparent area on an X-ray that can indicate an acute fracture).

A review of P#1's medical record revealed that an orthopedic provider was consulted. He recommended keeping P#1's left wrist in a splint, although P#1 refused to wear it and would see P#1 outpatient upon discharge.

A review of the "Flowsheets" revealed that on 11/1/24, P#1's Hester-Davis fall assessment score was ten, considered low-risk. Further review of the flowsheet fall risk guidance revealed that low-risk fall interventions include but are not limited to a patient ID band, patient and family fall education, green fall precaution signage outside the patient door, and not leaving patients unattended while toileting or in the bathroom.

A continued review revealed that on 11/2/24 at 12:15 a.m., P#1's score was changed to 27, considered a high-fall risk.

A review of the facility's "Incident Safe Report Log," dated 5/1/2024 through 11/12/24, revealed that P#1 was entered into the log on 11/2/24 related to a fall in the patient's bathroom.

During a telephone interview on 11/13/24 at 12:00 p.m. with RN AA, RN AA said she recalled that P#1 was always ready to leave and would tell her family she was being discharged when she was not. She added that it became a big enough issue for her Charge Nurse to get involved.

RN AA explained that P#1 had been up moving around when her family was visiting, but the family had left, and she had gone into P#1's room to give her medication. P#1 said she wanted to go to the bathroom. RN AA said that she assisted P#1 to the bathroom, and P#1 requested privacy. RN AA complied but left the door slightly cracked. RN AA explained that while she waited for P#1, she decided to straighten up P#1's bed when, a short moment later, she heard a sound in the bathroom. RN AA said that she observed P#1 on the floor when she opened the door and called for another staff member to assist her in getting P#1 back to her bed.

RN AA said she asked P#1 what happened. P#1 explained that she was in the process of wiping, and when she leaned forward, she had vertigo (a symptom that causes a person to feel like they or the world around them is spinning or moving when they are not), and she fell off the toilet.

RN AA explained that she notified the provider and charge nurse and an assessment of P#1 was conducted. P#1 complained of wrist pain and was sent for an X-ray (a type of electromagnetic radiation that can be used to create images of the inside of the body). The results of the X-ray revealed that P#1 sustained a wrist fracture as a result of the fall.

RN AA said P#1's arm was put in a sling to immobilize the wrist, and an orthopedic consultation order was placed on 11/1/24. She recalled that P#1 was on a no-fall or low-fall risk protocol that day. RN AA added that if a patient is on a moderate or high fall risk protocol, they cannot ambulate independently and should always have someone with them when they are out of bed.

During an interview on 11/13/24 at 2:00 p.m. with the Chief Nursing Officer (CNO) FF in a conference, CNO FF explained that when patients are admitted to the facility, she expects nursing staff to conduct a fall-risk assessment using the Hester-Davis Scale (patient fall risk evaluation tool). In addition to using the assessment tool, she expects nursing staff to know and follow the facility's fall-risk policy and protocols.

During a telephone interview on 11/13/24 at 3:20 p.m. with RN EE, RN EE said she has worked as an RN for the facility since January 2023. RN EE recalled P#4 because she had been assigned to him once during his admission.

RN EE was asked to explain the facility's fall risk assessment policy and procedure. RN EE explained that based on how the patient answers the assessment questions, they are given a score of 0-7, which is low risk, 8-14 is moderate risk, and 14 and higher is high risk.

RN EE added that if the patient is assessed as a moderate or high fall risk, a sign is placed on the patient door, they wear a yellow patient gown, a bed alarm is set, fall mats are placed on the floor, and patients are not allowed to ambulate independently.

RN EE said that a moderate or high fall-risk patient should never be left alone in the bathroom or ambulate independently without assistance. She added that it is common for patients to lean forward and fall when they try to get up. She said some patients fall during admission, and when that happens, they assess the patient for injuries, notify the physician and charge nurse, and create an incident report.

A telephone interview was conducted on 11/13/24 at 4:00 p.m. with Patient Care Technician (PCT) GG. PCT GG recalled that P#1 was not in restraints when she was her sitter, but she did recall that P#1 was on fall-risk precautions because she was wearing a yellow patient gown, gait belt, sticky socks, and a fall-risk bracelet. PCT GG said that when P#1 would get up to move to her chair or the bathroom, she would walk with her and stand by the cracked bathroom door to ensure she didn't fall over.

Based on a review of policy and procedures, review of medical records, and staff interviews, it was determined that the facility failed to maintain active restraint orders for restrained patients and failed to ensure that restrained patients were monitored at intervals of two hours as per the facility's policy. Specifically, the facility failed to:

1. Provide a current documented restraint order for a patient while in restraints. This affected one patient (P) (P#1) of four sampled patients.

2. Monitor and document restraint assessments on patients in non-violent restraints at two-hour intervals. This affected two (P#1 and P#4) of four sampled patients.

Findings Included:

A review of the facility's policy titled "Patient's Rights and Responsibilities," effective 9/18/21, revealed that the policy's purpose was to establish guidelines for patient care that recognize each patient as an individual with unique healthcare needs, values, and cultural perspectives. The policy also aimed to respect, promote, and protect each individual's basic human rights.

POLICY STATEMENT:
Emory Healthcare respects the rights of the patient and focuses on each patient's personal dignity while providing considerate, respectful care focused on the patient's individual care needs. The hospital prohibits discrimination based on age, race, ethnicity, religion, culture, cultural beliefs, personal values, language, physical or mental disability, socioeconomic status, gender, sexual orientation, gender identity or expression, or payment source.

All patients at the facility were entitled to the rights listed below:
o Expect care to be given in an environment free from neglect, exploitation, and verbal, mental, physical, and sexual abuse.

A review of the facility's policy titled "Restraint," effective 4/12/23, revealed that the policy's purpose was to provide guidelines for using restraint and/or seclusion to promote the safe and appropriate use and monitoring of restraint or seclusion.
POLICY:
In all cases, the use of restraints or seclusion would require a physician order and would be in accordance with written facility policy, applicable law/regulation, and a written modification of the patient's plan of care. Time frames for the ongoing monitoring of the patient's psychological and physical status during the use of restraint or seclusion would be defined as follows:
o Patients restrained due to unsafe or therapeutically disruptive behavior will be assessed every 2 hours or more frequently as needed.
DEFINITIONS:
In general, if a patient can easily remove a device intentionally in the same manner as it was applied by a staff member, it would NOT be considered a restraint.

1. Medical/Non-violent/Therapeutically Unsafe/Disruptive Behavior - Behavioral changes primarily related to a patient's medical/surgical condition, and the behavior resulted in interference with necessary treatment. Examples include pulling at lines, tubes, or dressings, dementia, delirium, and behaviors such as agitation, restlessness, confusion, disorientation, and being unaware of physical limitations.

PROCEDURES:
Restraint Devices Include but are not limited to:
1. Wrist-soft limb restraint (soft, non-rigid, cloth-like material)
Continuous Monitoring and Care of the Restrained Patient
1. The condition of the patient and the restraint used must be continually assessed, monitored, re-evaluated, and documented. The frequency of re-assessment is dependent upon the condition of the patient.
a. If medical restraints are in use, the patient must be visually checked for a minimum of every two hours and observed for psychological well-being, behavior, and general safety.
b. Every two hours, or more frequently as needed, the RN will assess:
1) Respiratory effort
2) Circulation of each restrained extremity
3) Skin integrity
4) Level of consciousness
c. Every two hours, or more frequently as needed, the patient must:
1) Have restraints released/be assisted in changing positions/have ROM exercises performed.
2) Have fluids and nourishment provided.
3) Have the opportunity to use the toilet. Bedpan or urinal as appropriate.
4) Be assessed for patient readiness for release from restraints.
Removal of Restraint
Removal of restraint must be initiated by the physician or registered nurse when the patient meets the criteria for discontinuation.
a. If the restraint and/or seclusion is discontinued prior to the expiration of the original order, and re-initiating of restraint and /or seclusion is indicated, a new order must be obtained.
Documentation Requirements
4. Assessment and care:
a. Alternatives attempted
b. Assessment of behaviors exhibited by the patient to determine the need for the use of restraints and/ or seclusion and assessment of the causative factors of those behaviors.
c. Intervention and patient's response to the intervention
d. Evaluation
e. Criteria for discontinuation
5. Written modification to the patient's plan of care when restraint/seclusion is initiated and/or discontinued. There will be a described intervention, the goal of the intervention, and responsibility for the implementation of each intervention specified. The plan of care should be reviewed and updated in writing within 12 hours.


1. A review of P#1's medical record revealed that a non-violent restraint order was placed on 10/21/24 at 11:52 p.m. The order was indicated for interference with medical treatment. The type of restraints was marked bilateral soft wrist, and the duration was marked as continuous twenty-four (24) hours, with the order expiring on 10/22/24 at 11:52 p.m.


Continued review revealed that on 10/23/24 at 3:53 a.m., the EMR system automatically discontinued the 10/21/24 restraint order.


A review of P#1's medical record revealed that P#1 was in documented restraints from 10/22/24 at 11:52 p.m. to 10/23/24 at 3:53 a.m. without an active physician-signed restraint order. Additionally, the flowsheets failed to reveal a documented two-hour assessment at 2:00 a.m. P#1 was reassessed four hours later at 4:00 a.m. and released from the restraints.


A continued review of "Flowsheets" revealed that 10/23/24 restraint assessments were documented at 11:24 a.m., 12:17 p.m., 1:30 p.m., and 3:30 p.m. All documented assessments had a time stamp of 5:36 p.m. Additionally, restraint assessments were required on 10/29/24 at 8:00 p.m. and 10:00 p.m. and 10/30/24 at 12:00 a.m. and 2:00 a.m. The referenced assessment dates and times had a date and time stamp of 10/30/24 at 3:09 a.m.


2. A review of P#4's medical record revealed a 66-year-old male who was brought to the facility by emergency medical services (EMS) from a nursing home and admitted to the facility on 9/1/24 for ongoing low oxygen saturation and increased confusion.


A review of the medical record revealed that P#4 had a past medical history of asthma (a chronic inflammatory disease that affects the airways of the lungs), end-stage renal disease (ESRD) (a condition that occurs when the kidneys can no longer function properly), diabetes mellitus (a chronic disease that occurs when the body has high blood sugar levels), hypotension (a condition where the force of blood flowing through your body's blood vessels is lower than normal), and Lewy body dementia (a brain disorder that can lead to problems with thinking, movement, behavior, and mood).


A continued review revealed that a non-violent restraint order was placed on 9/19/24 at 1:08 a.m. The restraint order was indicated for interference with medical treatment. The type of restraints marked on the order were bilateral soft, wrist, and the duration was continuous twenty-four (24) hours, with the order expiring on 9/20/24 at 1:08 a.m.


A review of "Flowsheets" failed to reveal that on 9/19/24, restraint assessments were conducted on P#4 from 8:00 a.m. until P#4's time of death at 5:59 p.m.


During an interview on 11/13/24 at 12:35 p.m. with Registered Nurse (RN) DD in a conference room, RN DD explained that she recalled being the primary nurse for P#4 on 9/19/24.

RN DD recalled that P#4 had two-point, bilateral, soft restraints on his left and right wrists because he had been pulling at his intravenous line (IV) (a soft, flexible tube placed inside a vein used to give a person medicine or fluids) and his nasogastric (NG) tube (a thin, flexible tube inserted through the nose and into the stomach to deliver food, liquids, or medication or remove substances from the stomach).

RN DD explained that when patients are placed in nonviolent, soft restraints, they must be assessed by an RN every two hours. She added that every assessment is documented in the patient's electronic medical record (EMR).

RN DD was asked to review P#4's medical record. Specifically, she was asked to review the restraint orders and the restraint assessment documentation for 9/19/24. RN DD immediately observed and acknowledged that no restraint assessments were documented on 9/19/24. RN DD said, "Oh my god, I didn't document."

RN DD said she does not keep up with when she needs to conduct a restraint assessment because the EMR system prompts a reminder on the screen for the nurse to enter the two-hour reassessment documentation. RN DD could not think why she would miss documenting restraint assessments for ten-plus hours.

RN DD explained that another RN initiated a code blue after being alerted by P#4's family member that he was no longer breathing. RN DD recalled that when she entered P#4's room, he was still in restraints, but she could not recall whether they were tied or untied.


A telephone interview was conducted on 11/13/24 at 1:01 p.m. with RN BB. RN BB explained that an assessment is conducted every two hours and documented in the medical record. RN BB recalled documenting P#1's restraint assessments and explained that he would never miss documenting an assessment because the EMR prompts it. Many assessment questions must be answered and documented, and he would not forget that.


During an interview on 11/13/24 at 2:00 p.m. with the Chief Nursing Officer (CNO) FF in a conference room, CNO FF was asked to explain her staff expectations regarding nonviolent restraint assessments and documentation. CNO FF said she expects nursing staff to confirm they have an order from a medical doctor (MD), conduct two-hour patient assessments, and document every assessment without exception.


During a telephone interview on 11/13/24 at 3:00 p.m. with RN CC, she explained that patients in non-violent restraints are assessed hourly, and the assessment should be documented in the EMR. When a restraint order is about to expire, the EMR will prompt an alert. She added that when she gets the expiration alert, she will assess the patient and call the provider for a new order if needed.


During a telephone interview on 11/13/24 at 3:20 p.m. with RN EE, RN EE recalled P#4 because she had been assigned to him once during his admission. RN EE explained that on 9/19/24, she was not assigned to P#4, but his family had flagged her down and told her that P#4 was not breathing. RN EE recalled seeing P#4 in soft wrist restraints when he expired. RN EE further revealed that patients in non-violent restraints should be assessed every two hours and that the assessment needs to be documented in the medical record. She explained that the physician is supposed to renew the restraint order every 12 hours. She said that some physicians will give verbal orders, but the order should be put in by the physician directly.