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Based on review of medical records, hospital policy, and staff interview, it was determined the hospital failed to ensure each order for restraint used to ensure the physical safety of the non-violent or non-self-destructive patient was renewed as authorized by hospital policy for 2 of 4 patients who were restrained (#3 and #4) and whose medical records were reviewed. This resulted in unauthorized restraint use. Findings include:

The hospital policy "Restraint/Seclusion," dated 11/23/15, was reviewed. The policy included, but was not limited to, the following information:

- "Duration of order for restraint use must not exceed twenty-four (24) hours for the initial order..."

- "If reassessment indicates an ongoing need for restraint, a new order must be written each calendar day..."

The policy was not followed. Examples include:

1. Patient #3 was a 53 year old female who was admitted to the hospital on 12/26/16. Restraint orders were reviewed from 1/15/16 through 1/25/16. Restraint orders included, but were not limited to, the following dates and times:

- 1/15/16 12:05 AM (Initial)

- 1/15/16 11:42 AM (renewal)

- 1/17/16 2:30 PM (renewal)

There were no documented restraint orders on 1/16/16.

Medical record documentation indicated Patient #3 was restrained continously from 1/15/16 through 1/17/16.

The ACNO was interviewed on 2/02/16 at 10:09 AM. She reviewed Patient #3's medical record and confirmed Patient #3 continued in restraints on 1/16/16 without a renewal order for 1/16/16.

Restraint orders were not renewed in accordance with hospital policy.



00023

2. Patient #4 was a 78 year old male who was admitted to the hospital on 1/21/16 and died on 1/24/16 at 7:00 PM.

Patient #4's medical record documented an order for bilateral wrist restraints in the ICU on 1/23/16. The order was dated 1/23/16 at 3:30 PM and stated "Utilize restraints for the next 24 hours (not to exceed 24 hours)." The medical record documented Patient #4 remained in restraints until his death. The order for wrist restraints was renewed on 1/24/16 at 6:38 PM, 27 hours after the initial restraint order.

Patient 4's medical record was reviewed with the ACNO on 2/02/16 beginning at 10:05 PM. She confirmed the restraint order was not reviewed within the 24 hours prescribed by the order and hospital policy.

Patient #4's restraint order was not renewed in accordance with hospital policy.

Based on medical record review, policy review, and staff interview, it was determined the hospital failed to ensure there was medical record documentation of the condition or symptom(s) that warranted the use of restraints for 2 of 4 patients (#1 and #3) whose medical records were reviewed. This resulted in a lack of clarity as to whether the least restrictive restraints were utilized. Findings include:

Patient #3 was a 53 year old female who was admitted to the hospital on 12/26/16 for care in the ICU related to vascular disease, necrotric muscle, and related complications.

Physician documentation included restraint orders, dated 1/25/16 6:30 AM, for 4 point soft restraints for 24 hours for "pulling at line(s)." There was no documentation that explained how pulling at lines justified leg restraints. Review of nursing notes documentation for 1/25/16 did not include an explanation as to why it was necessary to restrain Patient #3's legs.

The ACNO and Director of Respiratory/ICU were interviewed together on 2/02/16 at 10:23 AM. The Director of Respiratory/ICU explained the reason Patient #3 needed leg restraints was because she had a large groin wound with a wound vac and leg movement was interfering with her medical care. The ACNO and the Director of Respiratory/ICU confirmed documentation did not clearly explain the reason for the leg restraints.

The hospital policy "Restraint/Seclusion," dated 11/23/15, was reviewed. The policy did not specifically address the requirement to document the patient's condition or symptom(s) that warranted the use of restraints. The policy was limited to the following documentation requirements:

"The medical record contains documentation of:
a. Assessment of risk for restraint or seclusion
b. Restraint or seclusion alternatives employed
c. Determination of effectiveness/ineffectiveness of restraint or seclusion alternatives
d. Second tier review of need for restraint or seclusion
e. Order for restraint or seclusion and any renewal orders for restraint or seclusion
f. Restraint or seclusion application/initiation
g. Family notification of restraint or seclusion use
h. Patient and family education regarding restraint or seclusion use
i. Assessment of the patient in restraint or seclusion
j. Monitoring of the patient in restraint or seclusion
k. Medical and behavioral evaluation for restraint or seclusion management of violent or self-destructive behavior
l. Modifications of the plan of care
m. Physician notification of changes in patient condition
n. Restraint or seclusion removal/termination
o. Document requirements related to deaths of patients..."

Patient #3's medical record did not include clear documentation as to the patient's condition or symptoms that warranted the use of leg restraints.



00023

2. Patient #1 was a 64 year old female who was admitted to the hospital on 1/20/16 after a 35 foot fall. She suffered an open fracture of her right femur and fractures of her right elbow, jaw, face, right hip, and pelvis.

A ventilator flow sheet stated Patient #1 was intubated at 1:20 PM on 1/20/16. A nursing progress note, dated 1/20/16 at 1:06 PM, stated soft restraints were applied on all 4 extremities. Another nursing progress note by another RN, titled "Restraints Evaluation/2nd Tier Review and dated 1/20/16 at 1:09 PM, stated Patient #1 had restraints applied to both upper extremities and to her left lower extremity. Nursing progress notes documented Patient #1 remained restrained until 8:40 PM on 1/20/16. None of the progress notes documented the symptoms that required the use of restraints. A nursing progress note, dated 1/20/16 at 1:07 PM, stated "Behavior - Attempts to remove device. The note did not state which device Patient #1 was trying to remove or how she could use her right arm or leg to remove a device given the nature of her fractures.

The ED Director reviewed Patient #1's medical record on 2/02/16 beginning at 9:30 AM. He agreed the specific symptoms that required the use of restraints were not documented.

The symptoms that warranted the use of restraints for Patient #1 were not documented.

Based on review of medical records, hospital policy, and staff interview, it was determined the hospital failed to ensure each order for restraint used to ensure the physical safety of the non-violent or non-self-destructive patient was renewed as authorized by hospital policy for 2 of 4 patients who were restrained (#3 and #4) and whose medical records were reviewed. This resulted in unauthorized restraint use. Findings include:

The hospital policy "Restraint/Seclusion," dated 11/23/15, was reviewed. The policy included, but was not limited to, the following information:

- "Duration of order for restraint use must not exceed twenty-four (24) hours for the initial order..."

- "If reassessment indicates an ongoing need for restraint, a new order must be written each calendar day..."

The policy was not followed. Examples include:

1. Patient #3 was a 53 year old female who was admitted to the hospital on 12/26/16. Restraint orders were reviewed from 1/15/16 through 1/25/16. Restraint orders included, but were not limited to, the following dates and times:

- 1/15/16 12:05 AM (Initial)

- 1/15/16 11:42 AM (renewal)

- 1/17/16 2:30 PM (renewal)

There were no documented restraint orders on 1/16/16.

Medical record documentation indicated Patient #3 was restrained continously from 1/15/16 through 1/17/16.

The ACNO was interviewed on 2/02/16 at 10:09 AM. She reviewed Patient #3's medical record and confirmed Patient #3 continued in restraints on 1/16/16 without a renewal order for 1/16/16.

Restraint orders were not renewed in accordance with hospital policy.



00023

2. Patient #4 was a 78 year old male who was admitted to the hospital on 1/21/16 and died on 1/24/16 at 7:00 PM.

Patient #4's medical record documented an order for bilateral wrist restraints in the ICU on 1/23/16. The order was dated 1/23/16 at 3:30 PM and stated "Utilize restraints for the next 24 hours (not to exceed 24 hours)." The medical record documented Patient #4 remained in restraints until his death. The order for wrist restraints was renewed on 1/24/16 at 6:38 PM, 27 hours after the initial restraint order.

Patient 4's medical record was reviewed with the ACNO on 2/02/16 beginning at 10:05 PM. She confirmed the restraint order was not reviewed within the 24 hours prescribed by the order and hospital policy.

Patient #4's restraint order was not renewed in accordance with hospital policy.

Based on medical record review, policy review, and staff interview, it was determined the hospital failed to ensure there was medical record documentation of the condition or symptom(s) that warranted the use of restraints for 2 of 4 patients (#1 and #3) whose medical records were reviewed. This resulted in a lack of clarity as to whether the least restrictive restraints were utilized. Findings include:

Patient #3 was a 53 year old female who was admitted to the hospital on 12/26/16 for care in the ICU related to vascular disease, necrotric muscle, and related complications.

Physician documentation included restraint orders, dated 1/25/16 6:30 AM, for 4 point soft restraints for 24 hours for "pulling at line(s)." There was no documentation that explained how pulling at lines justified leg restraints. Review of nursing notes documentation for 1/25/16 did not include an explanation as to why it was necessary to restrain Patient #3's legs.

The ACNO and Director of Respiratory/ICU were interviewed together on 2/02/16 at 10:23 AM. The Director of Respiratory/ICU explained the reason Patient #3 needed leg restraints was because she had a large groin wound with a wound vac and leg movement was interfering with her medical care. The ACNO and the Director of Respiratory/ICU confirmed documentation did not clearly explain the reason for the leg restraints.

The hospital policy "Restraint/Seclusion," dated 11/23/15, was reviewed. The policy did not specifically address the requirement to document the patient's condition or symptom(s) that warranted the use of restraints. The policy was limited to the following documentation requirements:

"The medical record contains documentation of:
a. Assessment of risk for restraint or seclusion
b. Restraint or seclusion alternatives employed
c. Determination of effectiveness/ineffectiveness of restraint or seclusion alternatives
d. Second tier review of need for restraint or seclusion
e. Order for restraint or seclusion and any renewal orders for restraint or seclusion
f. Restraint or seclusion application/initiation
g. Family notification of restraint or seclusion use
h. Patient and family education regarding restraint or seclusion use
i. Assessment of the patient in restraint or seclusion
j. Monitoring of the patient in restraint or seclusion
k. Medical and behavioral evaluation for restraint or seclusion management of violent or self-destructive behavior
l. Modifications of the plan of care
m. Physician notification of changes in patient condition
n. Restraint or seclusion removal/termination
o. Document requirements related to deaths of patients..."

Patient #3's medical record did not include clear documentation as to the patient's condition or symptoms that warranted the use of leg restraints.



00023

2. Patient #1 was a 64 year old female who was admitted to the hospital on 1/20/16 after a 35 foot fall. She suffered an open fracture of her right femur and fractures of her right elbow, jaw, face, right hip, and pelvis.

A ventilator flow sheet stated Patient #1 was intubated at 1:20 PM on 1/20/16. A nursing progress note, dated 1/20/16 at 1:06 PM, stated soft restraints were applied on all 4 extremities. Another nursing progress note by another RN, titled "Restraints Evaluation/2nd Tier Review and dated 1/20/16 at 1:09 PM, stated Patient #1 had restraints applied to both upper extremities and to her left lower extremity. Nursing progress notes documented Patient #1 remained restrained until 8:40 PM on 1/20/16. None of the progress notes documented the symptoms that required the use of restraints. A nursing progress note, dated 1/20/16 at 1:07 PM, stated "Behavior - Attempts to remove device. The note did not state which device Patient #1 was trying to remove or how she could use her right arm or leg to remove a device given the nature of her fractures.

The ED Director reviewed Patient #1's medical record on 2/02/16 beginning at 9:30 AM. He agreed the specific symptoms that required the use of restraints were not documented.

The symptoms that warranted the use of restraints for Patient #1 were not documented.