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Based on observation, medical record review, facility policy review and staff interview, the facility failed to identify unsecured mitts as a restraint (A159). The facility failed to generate a care plan or update the care plan in a timely manner according to facility policy (A166). The facility failed to ensure physician orders were obtained for applied restraints (A168). The facility failed to ensure restraint renewal orders were obtained as per facility policy (A173). The facility failed to monitor patients with restraints every two hours per facility policy (175). The cumulative effect of these systemic practices resulted in the facility's inability to ensure the provision of quality health care in a safe environment.

Based on observation, facility policy review and staff interview, the facility failed to identify and address unsecured hand mitts as a restraint for four of six patients reviewed with mitts (Patient #4, #7, #8 and #10). The sample size was ten patients. The facility census was 760.

Findings include:

Review of the facility policy, "Use of Restraints" effective 05/01/17, defined a restraint as "Any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a person to move his or her arms, legs, body, or head freely." Under the heading of "Devices" the policy noted mitts to be a restraint "If tied down or if so tight or big as to prevent use of the hands," but not a restraint if "Not tied down; Patient can flex fingers and has access to his/her body."

Observation on the Neuro Critical Care Unit at 10:39 AM and 3:30 PM on 08/18/17 revealed Patient #4 to have unsecured (untied) mitts on and attempting to grab the probes from his/her head. The mitts were observed to restrict the function of the patient's fingers preventing the ability to grasp the probes.

Review of the medical record of Patient #7 nurse's note entry at 3:30 AM on 08/20/17 revealed the patient had mitts on both hands to prevent pulling tubes or repeatedly scratching the same area. There was no physician order for use of the device.

Observation of Patient #8 at 10:15 AM on 08/21/17 revealed the patient to have mitts, wrist restraints and a chest/vest restraint in place. Review of the medical revealed no order for the use of the mitts.

Observation of Patient #10 at 10:27 AM on 08/21/17 noted the patient to have mitts in place. Review of the medical record revealed no order for the use of the device.

These findings were verified during interview at the time of the observation with Staff O.

Based on medical record review and staff interview, the facility failed to develop/modify the care plan for the use of the restraints for seven of ten patients reviewed with restraints (Patient #1, #4, #5, #6, #7, #8 and #10). The sample was ten patients. The facility census was 760.

Findings include:

Review of the facility policy, "Use of Restraints" effective 05/01/17, revealed the section headed "Documentation Required" included "At the initiation of the restraints and every shift - alternatives attempted and document effectiveness; Every 24 hours - Review Plan of Care and update as need; At the discontinuation of the restraints - Restraint Discontinue Time, Discontinuing Criteria and Update the Plan of Care."

Review of the facility policy, "Plan of Care for OhioHealth Hospitals" effective 09/16/16 noted under the "Policy" heading at item four: "A member of the inter-professional team will identify relevant patient problems on admission and throughout the patient's stay. The team member will determine goals with expected end dates and select interventions for each problem. The outcome will be evaluated and the problem updated when care is initiated, upon the patient's progression or regression, and upon discharge. Based on the evaluation problems may be resolved at any time during the hospital stay."

1. Review of the medical record for Patient #1 revealed the patient was admitted to the facility on 07/11/17. Documentation revealed soft wrist restraints were applied the evening of admission due to the patient self-extubating. There was no restraint care plan developed until 07/14/17. This finding was verified with Staff B at 11:23 AM on 08/22/17.

Review of nursing documentation revealed the use of a vest restraint on 07/21/17 at 4:00 AM; however, there was no evidence of plan of care review every 24 hours. This finding was verified with Staff A at 10:35 AM on 08/21/17.

2. Review of the medical record for Patient #4 revealed soft bilateral wrist restraints were initiated on 08/15/17 at 10:11 PM and on 08/16/17, Restraint Use - Nonviolent/Non Self Destructive Behavior was added to the inpatient plan of care. Further review of the patient's record revealed the plan of care was reviewed only one time since the patient's inpatient admission on 8/16/17. This was verified by Staff A on 08/21/17 at 2:32 PM.

3. Review of the medical record for Patient #5 revealed a chest/vest restraint was initiated on 08/17/17 at 12:34 AM and a care plan was developed that date. A review note was added on 08/18/17 and documentation noted the restraints were discontinued on 08/19/17. There was no documentation on the care plan regarding the discontinuation. This was verified by Staff A on 08/21/17 at 3:26 PM.

4. Review of the medical record for Patient #6 revealed a chest/vest restraint was applied on 08/18/17 with the patient restrained through 11:00 AM on 08/21/17. The care plan was not developed until 08/22/17, after the removal of the restraint. The care plan entry for restraints was noted as resolved effective 08/21/17. This was verified by Staff A on 08/22/17 at 10:00 AM.

5. Review of the medical record for Patient #7 revealed a chest/vest restraint was initiated on 07/22/17 at 3:07 PM and at 3:09 PM on 07/22/17 soft bilateral wrist restraints, mitts, and all side rails were added. The initial care plan was developed on 08/06/17 and lacked evidence of every 24 hour review. This was verified on 08/22/17 at 12:16 PM by Staff A.

6. Review of the medical record for Patient #8 revealed the patient was admitted on 08/12/17 and soft wrist restraints and all side rails were initiated at 8:37 PM on 08/22/17. Documentation noted review of the restraint care plan on 08/12/17, 08/18/17 and 08/22/17 only. This finding was verified with Staff A at 10:28 AM on 08/22/17.

7. Review of the medical record revealed Patient #10 was restrained initially on 08/21/17 at 7:54 AM with the restraints discontinued at 6:24 PM. Restraints were re-initiated at midnight on 08/22/17 and discontinued at 8:00 AM. The care plan was initiated on 08/21/17 with no entries reflecting the discontinuations or re-starts of the restraint. This was verified by Staff A on 08/22/17 at 2:11 PM.

Based on observation, policy review, medical record review and staff interview, the facility failed to ensure physician orders were obtained and/or followed for seven of ten patients reviewed with restraints (Patient #1, #2, #4, #5, #7, #8, and #10). The sample was ten patients The facility census was 760.

Findings include:

Review of the facility policy/procedure, "Use of Restraints" effective 05/01/17, revealed under the heading "Assessment" the following: "the RN may apply restraint devices, using the least restrictive appropriate type, so long as an order is obtained prior to, or, in the event of an emergency, immediately after, application. Staff must assess and monitor a patient's condition on an ongoing basis to ensure the patient is released from restraint or seclusion at the earliest possible time."

1. Patient #1 was admitted to the facility on 07/11/17 with abdominal pain and bowel ischemia. The patient was taken to surgery the afternoon of admission. Further review of the medical record noted documentation by the surgical resident at 10:36 PM on 07/11/17 which revealed Patient #1 had self-extubated.

Nursing restraint documentation noted soft wrist restraints were applied to Patient #1's wrists bilaterally at 5:00 PM on 07/11/17 with clinical justification of the patient pulling lines; pulling tubes; confused/disoriented. Review of the physician orders revealed there was no order placed for the restraints until 6:54 PM on 07/11/17. Documentation further revealed the bilateral wrist restraints were discontinued at 2:00 PM on 07/19/17 and unsecured mitts were applied until a new order was obtained at 3:07 AM on 07/21/17 when bilateral soft wrist restraints were reapplied. These findings were all verified with Staff A at 10:28 AM on 08/22/17.

Restraint documentation also noted the application of a chest/vest restraint at 4:00 AM on 07/21/17. There was no order in the patient's record. This finding was verified by Staff A at 10:35 AM on 08/21/17.


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2. Review of the medical record for Patient #2 revealed bilateral soft wrist restraints were applied on 08/17/17 at 9:55 PM and remained in place until 9:47 AM on 08/20/17. On 08/17/17 at 9:55 PM, soft limb restraints for all four extremities was ordered. The medical record lacked restraint orders on 08/18/17. The restraint orders on 08/19/17 and 08/20/17 were for bilateral soft wrist restraints. The order dated 08/20/17 at 3:34 PM included bilateral soft wrist restraints and hand mitts. The medical record lacked documentation for ankle restraints or hand mitts. This was verified by Staff A on 08/21/17 at 3:02 PM.

3. Review of the medical record for Patient #4 revealed orders for soft bilateral wrist restraints on 08/15/17 at 10:11 PM and on 08/16/17 at 9:33 AM. The patient was placed in the bilateral soft wrist restraints and right mitt with side rails up on 08/15/17 at 10:15 PM. On 08/16/17 at 1:15 AM, bilateral soft wrist and mitts with a chest/vest restraint were applied. The mitt restraints were discontinued on 08/16/17 at 8:00 AM and at 11:35 AM all restraints were discontinued. On 08/16/17 at 1:15 PM, a chest/vest restraint was applied and remained in place through 08/19/17 at 6:00 PM when discontinued. The medical record contained orders on 08/16/17 at 12:59 PM and 08/17/17 at 11:46 AM for a chest/vest restraint. The orders for 08/18/17, 08/19/17. and 08/20/17 were for a chest/vest restraint and bilateral hand mitts. The medical record lacked documentation of hand mitts in place, however hand mitts were observed during tour on 08/18/17 at 10:39 AM and 3:30 PM. This was verified by Staff A on 08/21/17 at 2:32 PM.

4. Review of the medical record for Patient #5 revealed the patient was placed in a chest/vest restraint at 12:35 AM on 08/17/17 with bilateral soft wrist restraints added at 12:42 PM. Both restraint types remained in place until discontinued on 08/19/17 at 8:58 AM. The medical record contained orders on 08/17/17 at 12:34 AM for a chest/vest restraint and at 12:37 PM for bilateral soft wrist restraints. The orders did not specify whether the wrist restraints were to be in addition to or in place of the chest/vest restraint. The medical record lacked documentation of restraint orders on 08/18/17. The order on 08/19/17 at 12:22 AM was for a chest/vest restraint and soft bilateral wrist restraints. This was verified by Staff A on 08/21/17 at 3:26 PM.

5. Review of the medical record for Patient #7 revealed restraints were applied on 07/22/17 at 3:07 PM and remained in place through 08/22/17. The medical record contained an order dated 07/22/17 at 3:07 PM for a chest/vest restraint and an order dated 07/22/17 at 3:09 PM for chest/vest, soft bilateral wrist, bilateral mitts, and all side rails up. Both of these orders were renewed daily through 07/30/17. The medical record contained an order dated 07/31/17 at 9:45 PM for a chest/vest restraint. An order dated 08/01/17 at 5:36 AM was written for bilateral soft wrist restraints and at 2:02 PM a second order was noted for chest/vest and soft limb restraints times four extremities. Orders for 08/02/17, 08/03/17, and 08/04/17 ordered soft bilateral wrist restraints and a chest/vest restraint. On 08/06/17 at 1:12 AM, bilateral soft wrist restraints and a chest/vest restraint were ordered and at 2:02 PM, chest/vest and soft limb restraints times four restraints were ordered. On 08/07/17, 08/08/17, and 08/09/17, chest/vest restraint and soft limb restraints times four extremities were ordered. On 08/10/17, chest/vest, bilateral soft wrist, mitts and side rails were ordered. On 08/11/17, a chest/vest restraint was ordered. On 08/13/17 at 5:11 AM, 10:27 AM, and 11:10 AM, a chest/vest restraint was ordered with a five hour duration with the comment until 10:00 AM. On 08/14/17 and 08/15/17, a chest/vest restraint was ordered. On 08/16/17, 08/17/17, and 08/18/17, a chest/vest restraint was ordered with a duration of 16 hours. On 08/19/17 at 2:38 AM, a chest/vest restraint was ordered with a duration of 8 hours and at 2:26 PM, a chest/vest restraint and all side rails up was ordered. On 08/20/17 and 08/21/17, chest/vest restraint and all side rails up was ordered. The medical record lacked restraint orders on 08/05/17 and 08/12/17.

On 07/22/17 at 3:07 PM through 07/31/17 at 1:30 PM, the patient was documented as having all side rails up and a chest/vest restraint on and no other restraint devices recorded. On 07/31/17 at 1:30 PM, the chest/vest restraint was discontinued but all side rails up was documented as continued with no further monitoring. On 08/01/17 at 4:15 AM, the chest/vest restraint was applied with all side rails up and padded for seizure precautions. The chest/vest restraint and side rails continued until 8:29 AM on 08/01/17 when bilateral soft wrist restraints were added with a comment that the wrist restraints were in place at this time. At 10:23 AM on 08/01/17 all restraints were discontinued per order. At 2:02 PM on 08/01/17, side rails were continued with soft restraints times all four extremities and a chest/vest restraint. These continued to be documented until 08/02/17 at 8:00 AM when bilateral soft wrist restraints were documented with no mention of the ankle or vest restraint. On 08/02/17 at 12:00 PM, documentation resumed for the chest/vest restraint and soft bilateral wrist restraints. These restraints continued until 08/06/17 at 6:30 PM when ankle restraints were added, so the patient had side rails, bilateral soft restraints times all four extremities and a chest/vest restraint. This continued until 08/07/17 at 8:00 AM when the ankle restraints were discontinued. The side rails, bilateral soft wrist restraints and the chest/vest restraint continued through 08/08/17 at 10:00 AM when the chest/vest was no longer noted, but the patient was documented to have side rails up, and bilateral soft wrist and mitt restraints on. This continued through 08/11/17 at 8:00 AM when all restraints were discontinued. At 5:30 PM on 08/11/17, the chest/vest restraint was re-started and continued through 08/22/17 with side rails up as well at times. This was verified on 08/22/17 at 12:16 PM by Staff A.

6. Observation of Patient #8 at 10:15 AM on 08/21/17 revealed the patient to have mitts, soft wrist restraints and a chest/vest restraint in place. Review of the medical revealed no order for the use of the mitts.

7. Observation of Patient #10 at 10:27 AM on 08/21/17 noted the patient to have mitts in place. Review of the medical record revealed no order for the use of the device.

Based on medical record review, policy review and staff interview, the facility failed to obtain physician orders for restraint renewals for four of ten patients reviewed with restraints (Patient #1, #2, #5, and #7). The sample size was ten patients. The facility census was 760.

Findings include:

Review of the facility policy, "Use of Restraints" effective 05/01/17, under the heading "Ongoing Orders" revealed "A renewal restraint order will be obtained for each calendar day while the patient is in restraints".

1. Review of the medical record of Patient #1 noted the initiation of bilateral wrist restraints on 07/11/17 due to agitation and restlessness and pulling at lines/tubes. The patient had self-extubated his/her airway. Review of the physician orders noted no renewal of the restraint for 07/16/17 until 3:48 AM on 07/17/17 despite documentation the restraints were in place. This finding was verified during interview with Staff A at 10:28 AM on 08/22/17.


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2. Review of the medical record for Patient #2 revealed bilateral soft wrist restraints were applied on 08/17/17 at 9:55 PM and remained in place through 08/20/17. The medical record lacked restraint orders on 08/18/17. This was verified by Staff A on 08/21/17 at 3:02 PM.

3. Review of the medical record for Patient #5 revealed the patient was placed in a chest/vest restraint at 12:35 AM on 08/17/17 and had bilateral soft wrist restraints added at 12:42 PM in addition to the chest/vest restraint. Both restraint types remained in place until discontinued on 08/19/17 at 8:58 AM. The medical record lacked documentation of restraint orders on 08/18/17. This was verified by Staff A on 08/21/17 at 3:26 PM.

4. Review of the medical record for Patient #7 revealed restraints were applied on 07/22/17 at 3:07 PM and remained in place through 08/22/17. The medical record lacked restraint orders on 08/05/17 and 08/12/17. The medical record contained renewal restraint orders on 08/13/17, 08/16/17, 08/17/17, 08/18/17, and 08/19/17 with ordered durations of five hours, eight hours, or 16 hours even though the patient was restrained all day on those dates. This was verified on 08/22/17 at 12:16 PM by Staff A.

Based on medical record review, facility policy review and staff interview, the facility failed to ensure restrained patients were monitored with documentation evidence every two hours for five of ten patients reviewed with restraints (Patient #1, #8, #4, #6, and #7). The sample size was ten patients The facility census was 760.

Findings include:

Review of the facility policy, "Use of Restraints" effective 05/01/17, revealed under the heading, "Care of the Patient" noted at item 2 "The patient in restraints for physical safety will be assessed by the Registered Nurse every 2 hours and documented in the medical record. Although specific portions of this monitoring may be performed and recorded by UAP's; the assessment must be performed by the registered nurse". Under the heading, "Delegation and Collaboration" the following was noted, "Applying and routinely checking a restraint can be delegated to Unlicensed Assistive Personnel (UAP). The Registered Nurse must complete the initial assessment, determine the type and number of restraints required, and documentation. The nurse directs the UAP by - Reviewing when and how to change a patient's position, toileting and skin care; and Instructing the UAP to notify the nurse immediately if there is a change in the level of patient agitation, skin integrity, circulation of extremities, or patient's breathing."

1. Review of the medical record of Patient #1 failed to show evidence of monitoring between 12:00 PM and 6:00 PM on 07/13/17 and between 4:00 PM and 8:00 PM on 07/17/17.

2. Review of the medical record of Patient #8 failed to show evidence of monitoring between 10:00 PM on 08/18/17 and 2:00 AM on 08/19/17; and between 2:00 PM and 6:00 PM on 08/19/17.

These findings were verified during interview with Staff A at 10:28 AM on 08/22/17.


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3. Review of the medical record for Patient #4 revealed restraints were applied on 08/15/17 at 10:11 PM and remained in place through 08/20/17. The medical record contained a notation of restraint check on 08/16/17 at 12:01 AM but lacked documentation of what checks were completed. The medical record lacked documentation of every two hour monitoring on 08/19/17 from 2:00 PM through 6:00 PM when discontinued. This was verified by Staff A on 08/21/17 at 2:32 PM.

4. Review of the medical record for Patient #6 revealed restraints were applied on 08/18/17 at 5:25 PM and remained in place until discontinued on 08/21/17 at 11:00 AM. The medical record lacked documentation of what type of restraint was in place on 08/20/17 at 11:00 PM through 08/21/17 at 3:00 AM and 3:00 AM through 7:00 AM during the every two hour monitoring checks. This was verified by Staff A on 08/22/17 at 10:00 AM.

5. Review of the medical record for Patient #7 revealed restraints were applied on 07/22/17 at 3:07 PM and remained in place through 08/22/17. The medical record lacked documentation of every two hour monitoring on 07/24/17, 07/25/17, 07/26/17, 07/28/17, 07/29/17, 07/30/17, 07/31/17, 08/01/17, 08/02/17, 08/03/17, 08/03/17, 08/04/17, 08/05/17, 08/10/17, 08/11/17, 08/12/17, 08/14/17, 08/15/17, 08/17/17, 08/20/17, 08/21/17, and 08/22/17. This was verified on 08/22/17 at 12:16 PM by Staff A.