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Based on observations, interviews, and record review, the facility failed to ensure the patients' rights were protected while in a restrictive setting. Specifically, the facility failed to ensure staff followed the manufacturer's instructions for use (IFU) for restraint equipment used for mechanical restraints for one of one patients reviewed who was placed in the restraint chair (Patient #4).

Findings include:

Facility policy:

The Seclusion and Restraints Policy read, the purpose of the policy is to protect the health, safety, rights, dignity and well-being of all patients; to designate the criteria by which it can be determined that the use of seclusion or restraint is warranted; to outline the procedures to be implemented by staff to assure the safe use of seclusion and restraint. Mechanical Restraint: physical device used to involuntarily restrict the movement of an individual or the movement or normal function of a portion of his or her body. Types of mechanical restraints include, but are not limited to: restraint sheets, camisoles, belts attached to cuffs, leather cuffs, and restraint chairs. Patients placed in mechanical restraints must be observed continuously throughout the procedure. A staff member is assigned to sit within arm's reach of the patient to ensure safety. At no time will a patient in mechanical restraints be left unattended. Staff is responsible for and will ensure that no person will harm or harass a person who is secluded and/or restrained.

References:

The Restraint, Safety Restraint Chair, and Seclusion Competency Validation read, demonstration of restraint chair includes applying the restraints with the patient's elbows on the back of the arm rest and placing the patient in a secure private area with 1:1 level of observation. Additional RN duties include 15-minute documentation. Apply the restraint and/or initiate seclusion in a manner that respects the patient's rights, confidentiality, dignity, privacy, and individuality. Install the shoulder strap by passing the free ends over the shoulders, under the armpits, and secure them to the shoulder strap clevises located on the back of the chair. Tighten by pulling down on the shoulder strap at the top back of the chair. Do not pull the shoulders back too far when tightening the shoulder straps. Straps must be even and secure on both shoulders.

The SoftGuard Safety Restraint Chair IFUs read, warning use of the SoftGuard Safety Restraint Chair without first reading and thoroughly understanding the instructions could cause injury or death. The SoftGuard Safety Restraint Chair is intended for the Psychiatric, Behavioral, and Medical environments to protect patients that need to be restrained because they are at risk of hurting themselves or the medical staff. If used properly it can reduce the risk of physical harm to both. Secure the ankle strap by passing the free end around the front ankle and securing it to the ankle strap clevis. Pull the ankle strap handle until snug while making sure the patient's heel is touching the rear of the foot plate. Repeat on the other ankle. Take one wrist and place that free arm on the arm rest of the SoftGuard Safety Restraint Chair. Secure the arm with the left arm strap making sure the wrist is down and flat on the arm rest. Pull the wrist strap snug. Place the forearm (elbow) centered over the elbow soft strap. Double latch the hook and loop strap around the free elbow. Repeat the above process for the last arm. Install the shoulder strap by passing the free ends over the shoulders, under the armpits, and secure them to the shoulder strap clevises located on the back of the chair. Tighten by pulling down on the shoulder strap at the top back of the chair. Do not pull the shoulders back too far when tightening the shoulder straps. Straps must be even and secure on both shoulders.

1. The facility failed to ensure a patient was placed in mechanical restraints per manufacturer's IFU.

A. Observation

i. On 5/18/23 at 2:46 p.m., observations were made of the facility video footage recorded of Patient #4 on 5/12/23 from 2:40 p.m. to 3:45 p.m. Observations showed on 5/12/23 at 2:55 p.m., Patient #4 was brought in a physical hold into the seclusion room which contained a SoftGuard Safety Restraint Chair. Observations showed Patient #4 remained in a physical hold by RN #4 and RN #5 and was placed directly into the restraint chair at 2:55 p.m. Observations showed the shoulder strap (one of the four straps used to restrain a patient in the SoftGuard Safety Restraint Chair) was not placed on the patient and remained off from when she entered the chair at 2:55 p.m., to when she was released from the chair at 3:31 p.m.

This was in contrast to the SoftGuard Safety Restraint Chair IFUs, which instructed the shoulder strap should have been placed over the shoulders and secured to the back of the chair. In addition, the restraint chair IFUs read the use of the SoftGuard Safety Restraint Chair without first reading and thoroughly understanding the instructions could cause injury or death.

B. Document Review

i. Review of the seclusion and restraint documentation for Patient #4 revealed on 5/12/23 at 2:27 p.m., RN #4 observed the patient self-harming in her room and had reopened two arm wounds. At 2:50 p.m., Patient #4 was placed in a physical hold to prevent self harm after RN #4 attempted verbal de-escalation. At 2:53 p.m., Patient #4 was escorted to the seclusion room in a physical hold by RN #4 and RN #5 after the patient attempted self-harm while in a physical hold. At 2:55 p.m., Patient #4 remained in a physical hold and was placed directly into the restraint chair in the seclusion room. Patient #4 remained in the restraint chair from 2:55 p.m. to 3:31 p.m.

C. Interviews

i. An interview was conducted with registered nurse (RN) #2 on 5/18/23 at 11:18 a.m. RN #2 stated nursing staff and mental health worker (MHW) staff were trained by the director of nursing on the use of the SoftGuard Safety Restraint Chair. RN #2 stated staff members were only allowed to use the restraint chair with patients once they had demonstrated competency in the use of the restraint chair. RN #2 stated staff received education by verbal and visual demonstration of the restraint chair use. RN #2 stated staff were required to demonstrate correct use of the restraint chair and pass The Restraint, Safety Restraint chair, and Seclusion Competency Validation prior to use of the restraint chair with patients.

ii. An interview was conducted with registered nurse (RN) #4 on 5/18/23 at 5:57 p.m. RN #4 stated he had received training on the restraint chair from the director of nursing and had passed The Restraint, Safety Restraint Chair, and Seclusion Competency Validation. RN #4 stated all of the restraint chair straps were required to be in place and secure when a patient was placed in the restraint chair. RN #4 stated if restraint chair straps were not placed correctly, the patient could continue to harm themselves. Upon review of the event, RN #4 stated he recalled the patient was restrained correctly with all of the straps on.

This was in contrast with the observation of the video footage which showed the shoulder strap was not placed on the patient.

iii. An interview was conducted with medical director (Director) #1 on 5/19/23 at 11:14 a.m. Director #1 stated incorrect use or application of the restraint chair could allow the patient to continue to harm themselves or restrict breathing, which could lead to death. Director #1 stated the restraint chair could cause harm if not used correctly, and the correct use of the restraint chair was the responsibility of the facility to ensure patient safety.