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Based on review of 1 of 10 medical records (#1), interview with facility staff and review of policies and procedures the governing body failed to effectively govern the conduct of the hospital's staff in the management of patient care. Patient #1 became unresponsive after restraints were applied and later died.

Findings include:

The hospital failed to appropriately apply a restraint, failed to have complete policy regarding the use of restraints and failed to train staff to assess patients that are in restrained and in distress, refer to A 115.

The hospital failed to provide appropriate supervision to direct care staff. In the course of using physical restraints, nursing services failed to assess and evaluate patient #1 when he was restrained and in respiratory distress (complaining of difficulty breathing). Patient #1 became unresponsive and later died, refer to A 385

The effect of this systemic problem resulted in the failure of the hospital's governing body to effectively direct quality patient care and a determination that an immediate jeopardy existed to the health and safety of patients.

Based on review of clinical records, policy and procedure review and staff interviews, it was determined that in 1 of 10 patients (Patient #1) , the hospital failed to maintain patient safety. The hospital failed to appropriately apply a restraint, failed to have complete policy regarding the use of restraints and failed to train staff to assess patients that are in restrained and in distress.

Findings include:

The hospital failed to appropriately apply a physical restraint, refer to A167.
The hospital failed to have a complete policy for training staff in the use of physical restraints, refer to A194.
The hospital failed to teach staff to assess patient's distress while in a physical restraint, refer to A202.

The cumulative effect of these systemic failures resulted in the hospital's inability to ensure patient safety which resulted in the death of patient #1.

Based on 1 of 10 clinical records reviewed (#1), staff interviews and review of facility policies and procedures the hospital failed to appropriately apply a physical restraint device. An incorrect sized restraint was applied in addition to two being used instead of one. Patient #1 became unresponsive after restraints were applied and later died.

Findings include:

The facility policy #2D.02 entitled; "Body Wrap Restraint Procedure" dated 10/12/2010 describes its purpose; "To outline a procedure for the safe, therapeutic use of the body wrap restraint."
"II. Body Wrap as a Transport Device"
"A. The body wrap may be used to move a patient from one location to another, for example, from the site of an episode to a seclusion room.
B. Guidelines in Application of the Body Wrap for Transport
1. The patient may be positioned prone in the body wrap or on his/her back with the top of the wrap extending above the shoulders to the middle of the patient's head, and the bottom of the body wrap covering the patient's knees. In cases where the patient is being transported and the body wrap does not extend from shoulders to knees, it is most important to have the wrap extend over the shoulder to provide sufficient support for the patient's head. the patient's arms must be placed straight at the patient's side prior to closing the body wrap."

On the morning of 01/08/2011 at 7:21 AM per clinical record review, patient #1 exited his room without a shirt, several staff asked him to return to his room and put on a shirt. Patient #1 continued toward the nursing station where staff L confronted him and asked that he return to his room. According to staff interviews (RCT H at 10:00 AM on 01/12/11, RN G at 4:05 PM on 01/11/11 and RN F at 12:30 PM on 01/12/11) patient #1 continued towards the exit pushing by the staff. Staff put their hands on patient #1's arms and attempted to redirect him back to his room. Per interview and clinical record review patient #1 continued to struggle in an attempt to make his way to the door. The patient dropped to the floor and lunged toward the door. Patient #1 was immobilized on the floor by 6 staff (RCTs H, J, K, L, M and N) who held his arms and legs. Patient #1 was offered the opportunity to return to his room, he stood and again attempted to lunge towards the exit. He was taken back down to the floor and immobilized by staff restricting the movement of his limbs by 2 staff holding each arm and 2 staff restraining pt. #1's legs. RN G obtained the first body wrap and placed it on patient #1. Patient #1 was able to free his arms so staff obtained a larger wrap. The larger body wrap was wrapped around the patient's torso and legs with the smaller one still in place around the patient's legs and lower torso. During the application of the wrap, according to RCT H on 01/12/11 at 10:00 AM, patient #1 complained that he couldn't breathe. According to RCT H the patient was told by RN G to relax. There was no evidence either through documentation review or interview that an assessment was done by the RN G before during or after the application of the wraps.

Per record review and staff interview patient #1 was then lifted from a prone position on the floor in the wraps and placed face down on a gurney. He was transported in this fashion the 20 feet to his room. Once in the room RN G noticed the patient's color was "wrong" and on further assessment he was discovered to be unresponsive. Patient #1 was removed from the wraps, placed on the floor on his back and CPR was initiated. Staff were unable to revive patient #1 and he was declared dead at 8:08 AM on 01/08/11.

During review of the Restraint Body Wrap training and manufacturers information on 01/20/11 at 2:15 PM, Education/Training Coordinator C confirmed that staff are not trained to use 2 restraint body wraps simultaneously.

On 01/20/11 at 2:50 p.m. during a telephone interview, Company Representative I, for the producer of the body wrap, confirmed that the company does not recommend using 2 body wrap restraints at one time for one patient.

Telephone interviews conducted on 01/20/11 with Night Supervisor RN F at 4:00 PM and with Day RN G at 4:25 PM confirmed that staff were not trained to use two body wraps simultaneously on one patient as was done on 01/08/11 on Patient #1.

Based on 1 of 10 clinical records reviewed (#1), staff interviews and review of facility policies and procedures the hospital failed to adequately train staff on how to determine restraint size. The hospital also failed to train staff on appropriate patient positions while in the restraints and the appropriate assessments to be made to ensure the patient's airway is open. The facility's body wrap policy also failed to address these areas.

Findings include:

The facility policy #2D.02 entitled; "Body Wrap Restraint Procedure" dated 10/12/2010 describes its purpose; "To outline a procedure for the safe, therapeutic use of the body wrap restraint."
"II. Body Wrap as a Transport Device"
"B. Guidelines in Application of the Body Wrap for Transport
3. During transport the patient's head should be kept level or slightly elevated. A staff person should be assigned to ensure the patient's head is protected throughout the carrying procedure to be sure the patient remains contained and is breathing freely."

During the application of the first body wrap restraint at 7:40 AM on 01/08/11 patient #1 was being restrained while in a prone position on the floor. RN G obtained the first body wrap and placed it on patient #1. Patient #1 was able to free his arms so staff obtained a larger wrap. The larger body wrap was wrapped around the patient's torso and legs with the smaller one still in place around the patient's legs and lower torso.

According to RCT H on 01/12/11 at 10:00 AM, patient #1 complained that he couldn't breathe. . According to RCT H the patient was told by the RN G to relax. Per interview with RN F on 01/12/11 at 12:30 PM; during the application of a second wrap the patient continued to talk complaining of an inability to breathe. Patient #1 was then lifted from the floor while in the wrap and placed face down on a gurney. There was no evidence either through documentation review or interview that a respiratory assessment was done by the RN before during or after the application of the wraps. Patient #1 was transported in this fashion the 20 feet to his room. While being transported RCT H noticed patient #1 had a "blue nose". Once in the room the RN G noticed the patient's color was "wrong" and on further assessment he was discovered to be unresponsive. Patient #1 was removed from the wrap, placed on the floor on his back and CPR was initiated. Staff were unable to revive patient #1 and he was declared dead at 8:08 AM on 01/08/11.

A review was done of the current Policy & Procedure for " Seclusion and Restraint " #2D.01 dated 12/13/10, " Body Wrap Restraint Procedure " #2D.02 dated 10/12/10 and the training materials for Physical Control Technique and printed out training Power Point Presentation. Education/Training Coordinator C confirmed on 01/20/11 at 2:15 PM, that these documents failed to include, the staff 's responsibility and actions if the patient being restrained is in distress.

Based on 1 of 10 clinical records reviewed (#1), staff interviews and review of facility policies and procedures the hospital failed to demonstrate staff were trained on proper medical assessment for a patient who is physically restrained and in respiratory distress.

Findings include:

The facility policy #2D.02 entitled; "Body Wrap Restraint Procedure" dated 10/12/2010, describes its purpose; "To outline a procedure for the safe, therapeutic use of the body wrap restraint."
"B. Guidelines in Application of the Body Wrap for Transport"
"3. During transport the patient's head should be kept level or slightly elevated. A staff person should be assigned to ensure the patient's head is protected throughout the carrying procedure to be sure the patient remains contained and is breathing freely."
There is nothing in the policy addressing special precautions for a patient placed prone in the body wrap.

The following information describes education provided staff for the control and assessment of a restrained patient's head. Education/Training Coordinator C confirmed that based on the training materials for Physical Control Technique for both 3 and 5 person techniques pages 2, and 3, one person is assigned to the head as follows:
1. " One palm on the forehead.
2. Secure the chin with your thumb just below the bottom lip.
3. Open airway- light press down on forehead and lift chin.
4. Check breathing- watch for chest rise & abdomen to rise and fall.
5. Check circulation -at carotid artery.
6. If the patient is spitting or actively resisting stabilize the head to the side.
7. Place hands on either side of the patient ' s face in a butterfly pattern (keep fingers away from mouth).
8. Turn the head to the side.
9. Lean forward so that you are over the head of the patient.
10. Fully extend your arms (lock elbows)
11. With your body in the correct position minimal pressure is necessary to maintain stabilization. "
" 3, 5 Person prone stabilization page 5
3 or 5 person prone same techniques as the supine except for the head- *never stabilize the head face down*
Anytime someone is stabilized on prone there is increased risk for positional asphyxiation. As soon as safely possible position the patient in a supine or sitting position. "
This training does not detail what is to be done if the patient is in respiratory distress.

On 01/20/11 at 2:00 PM a review was done of current Policy & Procedure for " Seclusion and Restraint " #2D.01 dated 12/13/10, " Body Wrap Restraint Procedure " #2D.02 dated 01/12/10 and the training materials for Physical Control Technique and printed out training Power Point Presentation with Education/Training Coordinator C confirmed, the documents failed to include, the staff 's responsibility and actions if the patient is being restrained and is in distress.

Per clinical record review on 01/11/2011 at 11:00 AM, patient #1 was admitted under a 48 hour emergency detention on the afternoon of 01/06/2011. During a violent episode during which the patient required restraint, RN G obtained the first body wrap and placed it on patient #1. Patient #1 was able to free his arms so staff obtained a larger wrap. The larger body wrap was wrapped around the patient's torso and legs with the smaller one still in place around the patient's legs and lower torso. During the application of the wrap, according to RCT H on 01/12/11 at 10:00 AM, patient #1 complained that he couldn't breathe. According to RCT H the patient was told by RN G to relax. There was no evidence either through documentation review or interview that an assessment was done by the RN before during or after the application of the wraps.
During the application of the wrap restraint, according to RCT H on 01/12/11 at 10:00 AM, patient #1 complained that he couldn't breathe, patient #1 was in a prone position while being restrained. According to RCT H the patient was told by the RN G to relax. Per interview with RN F on 01/12/11 at 12:30 PM; during the application of the wraps the patient continued to talk complaining of an inability to breathe. The patient was then lifted from the floor while in the wrap and placed face down on a gurney. Patient #1 was transported in this fashion the 20 feet to his room. There was no evidence either through documentation review or interview that an assessment was done by the RN before during or after the application of the wraps. While being transported RCT H noticed patient #1 had a "blue nose". Once in the room the RN G noticed the patient's color was "wrong" and on further assessment he was discovered to be unresponsive. The patient was removed from the wrap, placed on the floor on his back and CPR was initiated. Staff were unable to revive patient #1 and he was declared dead at 8:08 AM on 01/08/11.

On 01/20/11 at 4:00 PM during a telephone conference call Night Supervisor RN F who assisted with the control and restraint of Patient #1 on 01/08/11 stated that it would be difficult to stabilize the head during the use of prone restraint.

Night RN F could not remember anyone stabilizing Patient #1's head, per interview on 01/20/11 at 4:00 PM. RN F said patient #1 was aggressively fighting off staff as they were trying to control his limbs.

On 01/20/11 at 4:25 p.m. during a conference telephone interview Day RN G told Surveyors, she thought there were two technicians at Patient #1's head.

On 01/20/11 at 2:45 p.m. PI A stated that based on investigation the hospital was currently conducting, PI A thought RCT H was stabilizing the head.

Reviewing with PI A, the 3 different interviews on 01/20/11 at 4:45 PM ( PI A,RN F & RN G) information about who was responsible for head stabilization for Patient #1 on 01/08/11 when he was stabilized and restrained in a prone position, the 2 nurses involved could not identify who was stabilizing the head of Patient #1. PI A acknowledged that this lack of responsibility was a problem. Based on this information there was no indication per interview or record review that staff adhered to any of the steps outlined above for head stabilization and monitoring of patient #1's ability to breathe.

Education/Training Coordinator C confirmed on 01/20/11 at 2:15 PM that it is the facility's expectation that the person assigned to the head of a patient during restraint be vigilant in monitoring the head. This assigned person should monitor airway, breathing and circulation, and if there are signs of distress, informs nursing staff immediately. These expectations are not addressed in seclusion and restraint training or the body wrap policy.

Based on review of 1 of 10 clinical records (#1), review of facility policies and interview with staff, the hospital failed to provide appropriate supervision to direct care staff. In the course of using physical restraints, nursing services failed to assess and evaluate patient #1 when he was restrained and in respiratory distress (complaining of difficulty breathing). Patient #1 became unresponsive and later died.

Findings include:

Nursing services failed to provide supervision of nursing care, refer to A 395.

The effect of this systemic failure resulted in nursing services inability to ensure the safety of restrained patients.

Based on review of 1 of 10 clinical records (#1), review of facility policies and interview with staff, nursing services failed to evaluate and intervene when patient #1 was restrained in a prone position and in respiratory distress (patient #1 complained of difficultly breathing). Patient #1 became unresponsive and later died.

Findings include:

Per record review on 01/12/2011 patient #1 was restrained in two body wraps during a violent episode on the morning of 01/08/11. During the application of the wrap restraints, according to RCT H on 01/12/11 at 10:00 AM, patient #1 complained that he couldn't breathe; patient #1 was in a prone position while being restrained. According to RCT H the patient was told by RN G to relax. Per interview with RN F on 01/12/11 at 12:30 PM; during the application of the wraps the patient continued to complain of an inability to breathe. The patient was then lifted from the floor while in the wraps and placed face down on a gurney. Patient #1 was transported in this fashion the 20 feet to his room.

There was no evidence either through clinical record review or staff interview that an evaluation was done by RN G before, during, or after the application of the wraps. While being transported, RCT H noticed patient #1 had a "blue nose". Once in the room, RN G noticed the patient's color was "wrong" and on further assessment he was discovered to be unresponsive. The patient was removed from the wraps, placed on the floor on his back and CPR was initiated. Staff were unable to revive patient #1 and he was declared dead at 8:08 AM on 01/08/11.

Education/Training Coordinator C confirmed on 01/20/11 at 2:15 PM that it is the facility's expectation that the person assigned to the head of a patient during restraint be vigilant in monitoring the head. This assigned person should monitor airway, breathing and circulation, and if there are signs of distress, informs nursing staff immediately. These expectations are not addressed in seclusion and restraint training or the body wrap policy.