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Based on interview and record review, the facility's Governing Body failed to ensure the timely review and implementation of the facility's Restraint and Seclusion policy and practices resulting in patients being placed in restraints without physician's orders and failed to implement the Manufacturer's instructions for the use of the Restraint Chair.

- Patient #1 was placed in a restraint chair with chest, lap, bilateral leg and wrist restraints, without a physician's order, resulting in bruising to the patient.

- Patient#3's restraint order was not carried out or canceled, the order was used 3 hours later to restrain the patient and then was used again in the facility's ICU (Intensive Care Unit) for another 4 hours and was changed from violent to non-violent behavior without a physician's order.

- The facility did not ensure the Restraint Chair was being used according to the Manufacturer's instructions, "The patient should not be left in the Safety Restraint Chair for more than two hours. The Restraint chair two-hour time limit may be extended, but only under direct medical supervision (Doctor/Nurse)."


During an interview on the afternoon of 11/19/2019 and the morning of 11/20/2019 Staff #3 stated in part, "The Medic Tech program does not allow the physician's to order the type of restraint they want.... We are getting a new program... The facility has developed a paper form that covers all the types of restraints... We haven't started using the form, we are part of a larger health system, we want to all be using the same forms... " Staff #3 confirmed the facility did not have an implementation date or had modified the ordering systems to ensure the physicians and nurses were aware and placing the correct restraint orders and was not aware of the Restraint Chairs manufacturer's instructions for use.

Cross Refer to A0144 Patients Rights, A0386

Based on interview and record review, the facility failed to ensure patients receive care in a safe setting for three (3) out of eight (8) patients records reviewed for restraints. (Patients #1, 2, and 3)

a.) Patient #1 was placed in a restraint chair with chest, lap, bilateral leg and wrist restraints without a physician's order, resulting in bruising to the patient.

b.) Patient#3's restraint order was not carried out or canceled and the order was used 3 hours later to restrain the patient and then was used again in the facility's ICU (Intensive Care Unit) for another 4 hours and was changed from violent to non-violent behavior without a physician's order.

c.) Patient#2 was at risk of being placed in a restraint; the physician had written an order for restraints for a cooperative patient. The order was not implemented or canceled.

Cross Refer A0144 Patient Rights

Based on interview and record review, the facility failed to provide care in a safe setting for three (3) out of eight (8) patients records reviewed for restraints.

a.) Patient #1 was placed in a restraint chair with chest, lap, bilateral leg and wrist restraints without a physician's order, resulting in bruising to the patient.

b.) Patient #3's restraint order was not carried out or canceled; the order was used 3 hours later to restrain the patient and then was used again in the facility's ICU (Intensive Care Unit) for another 4 hours and was changed from violent to non-violent behavior without a physician's order.

c.) Patient #2 was at risk of being placed in a restraint; the physician had written an order for restraints for a cooperative patient. The order was not implemented or canceled.

Findings:

a.) Review of Patient #1's medical records reflected the patient was placed in a restraint chair, which included a chest, lap, bilateral leg and bilateral wrist restraints on 12/12/18 from 7:00 PM to 8:30 PM.

12/12/18 at 8:30 PM, the nurse's note reflected, "Pt in the restraint chair. She continues to yell from the chair, and uncooperative."

12/12/18 at 8:37 PM, the Care Plan note reflected, "PT RELEASED FROM RESTRAINT CHAIR AT THIS TIME, PT CALM AND COOPERATIVE."

12/12/18 at 9:40 PM, reflected, "NOTED REDNESS ON PT'S WRIST FROM RESISTING RESTRAINTS AND INCREASED VOLATILE BEHAVIOR FROM THE RESTRAINT CHAIR."


Review of Patient #1's physician's orders dated 12/12/18 did not reflect the order for the Chair Restraint or the Soft restraints. Further review revealed orders for soft restraints were written on 12/21/18, after the patient's discharge date.


During an interview on the afternoon of 11/19/19, in a facility conference room, Staff #5, ED Educator assisted in navigating the electronic record and confirmed the finding.


b.) Review of Patient #3's medical records reflected an order for restraints was placed on 9/21/19 at 6:44 am. The patient was not placed in the restraints at that time.

The nurse's notes dated 9:21 am reflected the following:

At 7:00 am, reflected the patient's behavior as Cooperative, Restless.

At 7:10 am., " ... PT IS COOPERATIVE BUT, JUST CANNOT STAY STILL.

At 10:10 am, " ...RECEIVED VERBAL ORDER FROM DR #15 TO PUT PT IN 4 POINT RESTRAINTS, SOFT DUE TO PT BEING A THREAT TO HIS OWN SAFETY AND STAFF NEEDING TO MEDICAL MONITOR HIS VITALS/CARDIAC RHYTHM CONTINUOUSLY."

At 10:15 am, "DR #15 SAID HE WILL PUT IN THE ORDERS FOR THE RESTRAINTS AND WILL PUT IN ANOTHER ORDER FOR HALDOL FOR THE PT TO HAVE 1 HOUR AFTER THE LAST DOSE." The order for the Haldol was put in but there was no order for the restraints.

At 10:15 am, soft bilateral hands, bilateral lower extremities, and a vest restraint were applied.

At 10:30 am, 10:45 am and 11:00 am, "Behavior Sleeping." The patient remained in restraints.

At 11:15 am, Patient #3 was transferred to the facility's Intensive Care Unit. The bilateral hands and the vest restraints remained in place. The admitting orders did not include an order to restrain the patient. The ICU Restraint Monitoring documentation reflected Non-Violent Restraint Justification Attempt to Get Out of Bed (+), Restraint applied at 11:24 am.

On 9/21/19 Patient #3 was assessed at 12:00 PM and 2:00 PM. The restraints were removed at 3:00 PM.

During an interview on the afternoon of 11/19/19, in a facility conference room, Staff #3, ED Director confirmed the finding and stated, the restraint order is to be implemented either shortly before or within an hour of the order. Staff #3 stated, a new order was needed at 10:15 am, when the restraint was applied, and when the restraint was changed from a Violent to a Non-violent restraint. Staff #3 stated, the restraint is to be removed as soon as possible; the facility is moving towards being restraint free.


c.) Review of Patient #2's medical records dated 5/2/2019 at 12:09 am, reflected a Physician's order was placed for a Restraint for violent behavior. The medical records did not reflect Patient #2 was violent, the restraint was not implemented, and the order was not canceled.

During an interview on the morning of 11/19/19, Staff #4, Nurse Manager, confirmed the findings.


POLICIES:

Review of the facility provided policy RESTRAINT & SECLUSION (revised February 6, 2017) reflected, " ...This policy addresses the use of restraint or seclusion in the acute care hospital setting. It is applicable to:

o All locations within the hospital (including medical/surgical units, critical care units, forensic units, emergency department, psychiatric units, etc.); and

o All hospital patients, regardless of age, who are restrained or secluded (including both inpatients and outpatients) ...
Physical restraint is 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 ...


RIGHTS OF PATIENTS

All patients have the right to be free from physical or mental abuse, and corporal punishment. All patients have the right to be free from restrain or seclusion, of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff. Restraint or seclusion may only be imposed to ensure the immediate physical safety of the patient, a staff member, or others and must be discontinued at the earliest possible time ...


REQUIREMENTS FOR ORDERING OF RESTRAINT OR SECLUSION FOR ANY REASON

This policy requires that a physician or other licensed independent practitioner (LIP) responsible for the care of the patient order restraint or seclusion prior to the application of restraint or seclusion.

In some situations, however, the need for a restraint or seclusion intervention may occur so quickly that an order cannot be obtained prior to application. In these emergency application situations, the order must be obtained either during the emergency application of the restraint or seclusion, or immediately (within a few minutes) afterwards. PRN Ordering of Restraint & Seclusion.

Orders for the use of restraint or seclusion must never be written as a standing order or on an as needed basis (PRN).

Staff cannot discontinue a restraint or seclusion intervention, and then re-start it under the same order. This would constitute a PRN order. A "trial release" constitutes a PRN use of restraint or seclusion, and, therefore, is not permitted.

o A temporary, directly-supervised release, however, that occurs for the purpose of [sic]caring for a patient's needs (e.g., toileting, feeding, or range of motion exercises) is not considered a discontinuation of the restraint or seclusion intervention. As long as [sic] the patient remains under direct staff supervision, the restraint is not considered to be discontinued because the
staff member is present and is serving the same purpose as the restraint or seclusion.

Notification of the Patient's Attending Physician

The attending physician must be consulted as soon as possible if the attending physician did not order the restraint or seclusion. The attending physician is the physician who is responsible for the management and care of the patient ....


ORDERING OF RESTRAINT OR SECLUSION FOR VIOLENT OR SELF DESTRUCTIVE
BEHAVIOR

Each order for restraint or seclusion used for the management of violent or self-destructive behavior (behavioral restraint or seclusion) that jeopardizes the immediate physical safety of the patient, a staff member, or others may only be obtained and renewed in accordance with the following limits for up to a total of 24 hours:

o Up to four (4) hours for adults age 18 and older;

o Up to two (2) hours for children and adolescents ages 9 to 17;

o Up to one (1) hour for patients under age 9.

If restraint or seclusion is discontinued prior to the expiration of the original order, a new order must be obtained prior to reinitiating the use of restraint or seclusion.

At the end of the time frame, if the continued use of restraint or seclusion to manage violent or self-destructive behavior is deemed necessary based on an individualized patient assessment, another order is required.

When the original order is about to expire, a Registered Nurse (RN) must contact the physician or other LIP, report the results of his or her most recent assessment and request that the original order be renewed. Whether or not an onsite assessment is necessary prior to renewing the order is left to the discretion of the physician or other LIP in conjunction with a discussion with the RN who is overseeing the care of the patient.

Orders for Restraint or Seclusion for Violent or Self-Destructive Behavior Beyond 24 Hours ...


DISCONTINUATION OF RESTRAINT OR SECLUSION

Restraint or seclusion must be discontinued at the earliest possible time, regardless of the length of time identified in the order. Restraint or seclusion may only be employed while the unsafe situation (clinical justification) continues. Once the unsafe situation ends, the use of restraint or seclusion must be discontinued.

Physicians, other LIP', and RN' involved in the patient's care are authorized by this policy to determine whether or not restraint or seclusion should be discontinued ...


APPLICATION OF RESTRAINT

Restraint shall be applied / removed in accordance with the following:

o The type of restraint used shall be consistent with the type of restraint ordered.

o Restraints will be applied with safe and appropriate techniques.

o Restraint devices are to be applied/removed in accordance with manufacturer's instructions and used in a manner consistent with their intended purpose.

o Restraint devices are to be applied / removed in a manner that preserves the dignity, comfort, and wellbeing of the patient.

o Restraints will be secured to the bedsprings or frame if being used while the patient is in bed. Restraints should never be tied to the mattress or side rails. Knots shall be tied so that they may be released quickly in the event of an emergency.

o Restraint devices are to be applied / removed only by staff authorized, trained, and with the demonstrated competency to do so ..."


Review of the manufacturer's Safety Restraint Chair Instructions (undated) reflected, "Warning - Use of the Safety Restraint Chair without first reading and thoroughly understanding the instructions could cause injury or death.

The Safety Restraint Chair is intended to help control combative, self- destructive, or potentially violent detainees. If used properly it can reduce the risk of physical harm to both the detainee and staff. Violent behavior may mask dangerous medical conditions therefore detainees must be monitored, or and provided with medical treatment if needed. Detainees should not be left in the Safety Restraint Chair for more than two hours. The Safety Restraint Chair should never be used as a means of punishment.

Caution: Belts and straps may need to be loosened to insure adequate blood flow. The Safety Restraint Chair must always be used in the upright position, leaving the chair on its side or back may cause injury or death to the detainee. Detainees should not be left in the Safety Restraint Chair for more than two hours. This time limit was established to allow for the detainee to calm down or sober up, and if needed it allows for the handlers to seek medical or psychological help for the detainee. This two- hour time limit may be extended, but only under direct medical supervision (Doctor/Nurse). This extended time- period must not exceed eight hours and range of motion exercises must be performed regularly. Therefore, we do not recommend anyone be left in the Safety Restraint Chair for more than ten hours total."

Based on interview and record review, the facility failed to ensure that nurses clarify and ensure appropriate physicians orders for three (3) patients records reviewed for restraints.

a.) Patient #1 was placed in a restraint chair with chest, lap, bilateral leg and wrist restraints without a physician's order, resulting in bruising to the patient.

b.) Patient #3's restraint order was not carried out or canceled, the order was used 3 hours later to restrain the patient and again in the facility's ICU (Intensive Care Unit) for another 4 hours and was changed from violent to non-violent behavior. The nurses did not ensure there was a physician's order for the restraints.

c.) Patient #2 was at risk of being placed in a restraint; the physician had written an order for restraints for a cooperative patient. The nurses did not clarify, implement or have the order canceled.

d.) The facility did not ensure the Restraint Chair was being used according to the Manufacturer's instructions. The patient should not be left in the Safety Restraint Chair for more than two hours. The Restraint chair two- hour time limit may be extended, but only under direct medical supervision (Doctor/Nurse).

Findings:

a.) Review of Patient #1's medical records reflected the patient was placed in a restraint chair, which included a chest, lap, bilateral leg and bilateral wrist restraints on 12/12/18 from 7:00 PM to 8:30 PM.

12/12/18 at 8:30 PM, the nurse's note reflected, "Pt in the restraint chair. She continues to yell from the chair, and uncooperative."

12/12/18 at 8:37 PM, the Care Plan note reflected, "PT RELEASED FROM RESTRAINT CHAIR AT THIS TIME, PT CALM AND COOPERATIVE."

12/12/18 at 9:40 PM, reflected, "NOTED REDNESS ON PT'S WRIST FROM RESISTING RESTRAINTS AND INCREASED VOLATILE BEHAVIOR FROM THE RESTRAINT CHAIR."

Review of Patient #1's physician's orders dated 12/12/18 did not reflect the order for the Chair Restraint or the Soft restraints. Further review revealed orders for soft restraints were written on 12/21/18, after the patient's discharge date.

During an interview on the afternoon of 11/19/19, in a facility conference room, Staff #5, ED Educator assisted in navigating the electronic record and confirmed the finding.


b.) Review of Patient #3's medical records reflected an order for restraints was placed on 9/21/19 at 6:44 am. The patient was not placed in the restraints at that time.

The nurse's notes dated 9:21 am reflected the following:

At 7:00 am, reflected the patient's behavior as Cooperative, Restless.

At 7:10 am., " ... PT IS COOPERATIVE BUT, JUST CANNOT STAY STILL.

At 10:10 am, " ...RECEIVED VERBAL ORDER FROM DR #15 TO PUT PT IN 4 POINT RESTRAINTS, SOFT DUE TO PT BEING A THREAT TO HIS OWN SAFETY AND STAFF NEEDING TO MEDICAL MONITOR HIS VITALS/CARDIAC RHYTHM CONTINUOUSLY."

At 10:15 am, "DR #15 SAID HE WILL PUT IN THE ORDERS FOR THE RESTRAINTS AND WILL PUT IN ANOTHER ORDER FOR HALDOL FOR THE PT TO HAVE 1 HOUR AFTER THE LAST DOSE." The order for the Haldol was put in but there was no order for the restraints.

At 10:15 am, soft bilateral hands, bilateral lower extremities, and a vest restraint were applied.

At 10:30 am, 10:45 am, and 11:00 am, "Behavior Sleeping." The patient remained in restraints.

At 11:15 am, Patient #3 was transferred to the facility's Intensive Care Unit. The bilateral hands and the vest restraints remained in place. The admitting orders did not include an order to restrain the patient. The ICU Restraint Monitoring documentation reflected Non-Violent Restraint Justification Attempt to Get Out of Bed (+), Restraint applied at 11:24 am.

On 9/21/19 Patient #3 was assessed at 12:00 PM and 2:00 PM. The restraints were removed at 3:00 PM.

During an interview on the afternoon of 11/19/19, in a facility conference room, Staff #3, ED Director confirmed the finding and stated the restraint order is to be implemented either shortly before or within an hour of the order. Staff #3 stated, a new order was needed at 10:15 am, when the restraint was applied, and when the restraint was changed from a Violent to a Non-violent restraint. Staff #3 stated, the restraint is to be removed as soon as possible; the facility is moving towards being restraint free.


c.) Review of Patient #2's medical records dated 5/2/2019 at 12:09 am, reflected a Physician's order was placed for a Restraint for violent behavior. The medical records did not reflect Patient #2 was violent, the restraint was not implemented, and the order was not canceled.

During an interview on the morning of 11/19/19, Staff #4, Nurse Manager, confirmed the findings.


POLICIES:

Review of the facility provided policy RESTRAINT & SECLUSION (revised February 6, 2017) reflected, "...Staff cannot discontinue a restraint or seclusion intervention, and then re-start it under the same order. This would constitute a PRN order. A "trial release" constitutes a PRN use of restraint or seclusion, and, therefore, is not permitted...

Notification of the Patient's Attending Physician

The attending physician must be consulted as soon as possible if the attending physician did not order the restraint or seclusion. The attending physician is the physician who is responsible for the management and care of the patient... At the end of the time frame, if the continued use of restraint or seclusion to manage violent or self-destructive behavior is deemed necessary based on an individualized patient assessment, another order is required...


DISCONTINUATION OF RESTRAINT OR SECLUSION

Restraint or seclusion must be discontinued at the earliest possible time, regardless of the length of time identified in the order. Restraint or seclusion may only be employed while the unsafe situation (clinical justification) continues. Once the unsafe situation ends, the use of restraint or seclusion must be discontinued...

o The type of restraint used shall be consistent with the type of restraint ordered.

o Restraints will be applied with safe and appropriate techniques.

o Restraint devices are to be applied/removed in accordance with manufacturer's instructions and used in a manner consistent with their intended purpose.

o Restraint devices are to be applied/removed in a manner that preserves the dignity, comfort, and wellbeing of the patient..."


d.) Review of the facility provided manufacturer's Safety Restraint Chair Instructions (undated) reflected, "Warning - Use of the Safety Restraint Chair without first reading and thoroughly understanding the instructions could cause injury or death.

The Safety Restraint Chair is intended to help control combative, self- destructive, or potentially violent detainees. If used properly it can reduce the risk of physical harm to both the detainee and staff. Violent behavior may mask dangerous medical conditions therefore detainees must be monitored, or and provided with medical treatment if needed. Detainees should not be left in the Safety Restraint Chair for more than two hours. The Safety Restraint Chair should never be used as a means of punishment.

Caution: Belts and straps may need to be loosened to insure adequate blood flow. The Safety Restraint Chair must always be used in the upright position, leaving the chair on its side or back may cause injury or death to the detainee. Detainees should not be left in the Safety Restraint Chair for more than two hours. This time limit was established to allow for the detainee to calm down or sober up, and if needed it allows for the handlers to seek medical or psychological help for the detainee. This two- hour time limit may be extended, but only under direct medical supervision (Doctor/Nurse). This extended time- period must not exceed eight hours and range of motion exercises must be performed regularly. Therefore, we do not recommend anyone be left in the Safety Restraint Chair for more than ten hours total."


During interviews on the morning of 11/20/2019, in a conference room, Staff #3, ED Director and Staff #5, ED educator confirmed the facility was not aware of the Manufacture's instructions and stated the restraint chair is the least restrictive restraint. Staff #5 stated, "Medictech does not allow them (physicians) to put in the Restraint Chair. When asked how the physician would communicate whether they did or did not want the restraint chair used, Staff #5 stated, "I think at the beside he could tell the staff."