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Based on medical record review, staff interview, and review of facility documentation, it was determined that the facility failed to ensure freedom of restraints by utilizing a medical device ("Self-release Belt/Patient Safety Belt") to restrict patient movement and in a way in which the medical device was not designed for use. (A-0159)

Based on staff interviews, medical record review, and review of facility documents it was determined that the facility failed to ensure freedom of restraints by utilizing a medical device to restrict patient movement, without appropriate documentation or orders by a physician, in a way in which the medical device was not designed for use.

Findings include:

Facility policy, "Restraints: Non-Violent Behavior" last reviewed 02/20/2024, states, "Definitions[:] ... 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, body, or head freely; ...Policy[:] ... 2. All patients have the right to be free from restraint, of any form ...11. The use of restraint is: 11.1 In accordance with a written modification to the patient's plan of care ... 12. The use of restraint is in accordance with the order of a physician or other LIP (Licensed Independent Practitioner) who is responsible for the care of the patient. ...Time Limits for Orders -Non-Violent Restraints or Non-Self Destructive[:] 1. If restraints are applied by a RN, the attending physician is consulted as soon as possible and no longer than 1 hour of initiation and an order is obtained at that time. 2. A written order based on an examination of the patient by the physician is entered into the patient's medical record within 24 hours of initiation of restraint. ... Documentation[:] 1. Use Electronic Medical Record Restraint Flow Sheet, restraint order forms and narrative notes to document all pertinent information in the medical record including but not limited to: ... 1.2 Alternatives attempted 1.3 Circumstances that led to use of restraint/seclusion 1.4 Physician/family notifications 1.5 Monitoring activities 1.6 Plan of Care/Treatment Plan - include criteria for discontinuation when applicable ..."

On 3/21/2024 at 10:40 AM, Staff (S)2, (Director of Performance and Quality) stated that on the night of 2/10/24-2/11/24, the night-shift nurse [S12] "placed a belt on Patient (P)1 as a protective device as [P1] kept trying to get out of bed and was getting out of bed all night needing to be reoriented as [P1] was a high fall risk ..."

When asked for the Instructions for Use (IFU) for this device, S2 stated, "we don't have it, we threw everything away since this incident." Instead, a print out from the manufacturer's website was provided, which lists this device under "Restraint Alternatives" and reads, "Self-release Belt [:] ...Designed to be used in either wheelchair or Geri-chair to keep the patient from sliding forward. ..."

Evidence that this device could be used on a bed was requested and was unable to be provided by the facility. Facility policy showing that this device could be used in the bed for patients at high risk of falls was requested and policies provided by the facility lacked evidence that this device was approved for use in a bed, for this purpose, and without a physician's order.

During an interview with S13, (RN PCU [Progressive Care Unit]) on 3/22/2024 at 1:33 PM, when asked if he/she ever saw another patient with this device applied to on a bed what type of documentation might you see in the chart, S13 stated, "if they were used [in that fashion] I would think it would be documented as a restraint and contain all elements of restraint documentation, I'm not really sure though because I really haven't ever seen them used."

Review of Medical Record (MR)1 lacked documentation of this device being applied to the patient (P1). MR1 also lacked documentation of P1's patient's behavior prior to application; physician notification, assessment, and order within one (1) hour; written modification to the patient's plan of care; and, that the patient was educated on device application and how to remove, if necessary, in the same manner in which it was applied by the staff member.

These findings were confirmed with S2 (Director of Performance and Quality), S6 (Registered Nurse [RN] Clinical Coordinator), and S11 (Director of Critical Care and PCU) on 3/22/2024 at 10:36 AM and again during the exit conference with S2, S3 (Chief Nursing Officer [CNO]), S4 (Administrative Director of Nursing [ADON]), and S11 on 3/22/2024 at 3:10 PM.

Based on staff interviews, medical record review, and review of facility documents, it was determined that the facility failed to utilize a medical device according to the Instructions for Use (IFU) and in a way that restricted Patient #1 (P1)'s ability to move freely.

Findings include:

Facility policy, "Restraints: Non-Violent Behavior" last reviewed 02/20/2024, states, "Definitions[:] ... 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, body, or head freely; ...Policy[:] ... 2. All patients have the right to be free from restraint, of any form ..."

On 3/21/2024 at 10:40 AM, Staff (S)2, (Director of Performance and Quality) stated that on the night of 2/10/24-2/11/24, the night-shift nurse [S12] "placed a belt on Patient (P)1 as a protective device as [P1] kept trying to get out of bed and was getting out of bed all night needing to be reoriented as [P1] was a high fall risk ..."

Review of P1's medical record (MR1) lacked documentation that this device was applied to the patient, the reason for this device being applied, and that the patient was educated on device application and how to remove, if necessary, in the same manner in which it was applied by the staff member.

When asked for the Instructions for Use (IFU) for this device, S2 stated, "we don't have it, we threw everything away since this incident." Instead, a print-out from the manufacturer's website was provided, which lists this device under "Restraint Alternatives" and reads, "Self-release Belt [:] ...Designed to be used in either wheelchair or Geri-chair to keep the patient from sliding forward. ..."

Evidence that this device could be used on a bed was requested and was unable to be provided by the facility. Facility policy showing that this device could be used in the bed for patients at high risk of falls was requested and policies provided by the facility lacked evidence that this device was approved for use in a bed, for this purpose, and without a physician's order.

During an interview with S13, (RN PCU [Progressive Care Unit]) on 3/22/2024 at 1:33 PM, when asked if he/she ever saw another patient with this device applied to on a bed what type of documentation might you see in the chart, S13 stated, "if they were used [in that fashion] I would think it would be documented as a restraint and contain all elements of restraint documentation, I'm not really sure though because I really haven't ever seen them used."

These findings were confirmed with S2 (Director of Performance and Quality), S6 (Registered Nurse [RN] Clinical Coordinator), and S11(Director of Critical Care and PCU) on 3/22/2024 at 10:36 AM and again during the exit conference with S2, S3(Chief Nursing Officer [CNO]), S4 (Administrative Director of Nursing [ADON]), and S11 on 3/22/2024 at 3:10 PM.