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Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.13, PATIENT RIGHTS, was out of compliance.

A-0154 USE OF RESTRAINT OR SECLUSION Patient Rights: Restraint or Seclusion. 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 restraint 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. Based on interviews and record review, the facility failed to follow facility policy and protocols when restraints were used on patients. This failure included the lack of implementation of least restrictive measures prior to the use of restraints, lack of assessment and monitoring of patients when in restraints, lack of provider orders for restraints, and the use of restraints as a fall precaution. The failure was identified in six of seven records reviewed of patients who were restrained (patients #4, #6, #7, #8, #9, and #10).

Based on interviews and record review, the facility failed to follow facility policy and protocols when restraints were used on patients. This failure included the lack of implementation of least restrictive measures prior to the use of restraints, lack of assessment and monitoring of patients when in restraints, lack of provider orders for restraints, and the use of restraints as a fall precaution. The failure was identified in six of seven records reviewed of patients who were restrained (patients #4, #6, #7, #8, #9, and #10).

Findings include:

Facility policies:

The Restraint and Seclusion policy read, a non-violent restraint is used to prevent the patient from disrupting necessary medical care. Restraint may only be imposed to ensure the immediate physical safety of the patient, staff members or others and must be discontinued at the earliest possible time. All patients have the right to be free from restraint or seclusion imposed as a means of convenience by staff. A comprehensive clinical assessment is completed prior to the implementation of restraint to protect the immediate safety of patients, visitors, and staff and must include an evaluation of environmental factors, as well as a physical assessment to identify medical problems. Evaluate whether alternatives to the use of restraint have been attempted. An order for restraint use must be obtained when the application of restraint(s) is deemed necessary. The order for restraint use must be placed at the start of a new restraint episode, this includes re-initiation of previously applied restraints.

Each order for restraint and seclusion used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, and others may only be renewed in accordance with the outlined age groups. The restraint used must be the least restrictive intervention that protects the patient's safety while providing the least risk and the most benefit to the patient. Less restrictive interventions do not always need to be tried, but less restrictive interventions must be determined by staff to be ineffective to protect the patient or others from harm prior to initiation of restraint. At least every 15 minutes, staff will monitor a restrained patient for circulation, airway, and that physical needs are met. The RN will monitor every two (2) hours, or more often, as indicated by the individual patient's medical needs and health status. The RN will document the clinical justification for restraint use and the progress toward restraint removal.

Appendix A of the Restraint and Seclusion policy read, the purpose of alternative strategies to avoid restraints was to describe appropriate interventions to help avoid the use of restraint or seclusion. This included but was not limited to, supervised physical activity, diversion activities, covered and secured lines, tubes, and drains, camera surveillance, and chair or bed alarms.

The Falls Prevention policy read, the hospital implements interventions to reduce falls based on the patient's assessed risk. Interventions will be initiated and individualized based on the fall risk category of the applicable fall risk assessment tool. Interventions are reselected in the electronic health record. Interventions for patients assessed as a moderate fall risk include using bed/chair alarms and providing diversional activities. Interventions for patients assessed as a high fall risk include utilizing a camera for surveillance and increased patient visibility.

Reference:

The Posey Vest Instructions for Use (IFU) read, the indications for use were for patients assessed to be at risk of injury from a fall. Before applying any restraint, follow the hospital's restraint policies and procedures that are compliant with United States of America (USA) Center for Medicare Services (CMS) guidelines and state laws or other governing agencies outside the USA. Severe emotional, psychological, or physical problems may occur. If symptoms of these problems ever appear for any reason, get help from a qualified medical authority and find a less restrictive product or intervention.

The Electronic Medical Record Fall Risk Interventions read universal fall risk precautions include the call light and frequently used items within reach.

1. The facility failed to ensure staff followed facility policies and processes for patients who were restrained.

A. Medical Record Review

i. On 9/1/23 Patient #4 was admitted to the facility for confusion and a head injury. On 9/11/23 a provider note read there was a low threshold to add a sitter (caregiver who provides patients in need of supervision with companionship and care) due to the patient's wander/fall risk, however, there was no staff available to cover as a sitter during the day. A review of the electronic medical record restraint flowsheets revealed staff initiated restraints at 11:30 a.m. on 9/11/23 because there was not an in-person sitter available for the patient. Further review of the medical record revealed least restrictive measures were not documented until 9/12/23 at 7:30 a.m., 20 hours after the restraints were initiated.

This was in contrast to the Restraint and Seclusion policy which read, the purpose of alternative strategies to avoid restraints was to describe appropriate interventions that helped avoid the use of restraint. Staff should have evaluated whether alternatives to the use of restraint had been attempted. Less restrictive interventions did not always need to be tried, but less restrictive interventions should have determined by staff to be ineffective to protect the patient or others from harm prior to initiation of restraint.

ii. On 7/5/23 Patient #6 was treated in the emergency department (ED) for alcohol intoxication and pain in his knee. A registered nurse (RN) note on 7/5/23 at 2:15 a.m. read, the patient followed commands reasonably, however the patient had a fall and was placed in two-point wrist restraints.

This was in contrast to the facility's Fall Prevention policy, which read interventions for moderate and high fall-risk patients included bed/chair alarms, diversional activities, and camera usage for surveillance and increased patient visibility.

There was no evidence in the medical record that high-fall risk interventions such as camera usage were attempted before the use of restraints.

iii. On 10/17/23 Patient #7 was admitted for alcohol use and rhabdomyolysis (a serious medical condition that occurs when damaged muscle tissue releases protein into the blood, damaging the heart and kidneys). A RN note from 10/20/23 read the patient was found on knees leaning on the edge of the bed, at which time a restraint order was placed for four bed side rails and a camera sitter. At 3:45 p.m., the patient attempted to climb out of bed and did not respond to redirection. The patient was then placed in two point wrist restraints. At 4:15 p.m., the RN was kicked in the back of the head by the patient and the patient was then placed in four-point restraints. A review of the non-violent restraint flowsheets revealed the patient was not assessed every 15 minutes on 10/20/23 from 3:45 p.m. to 7:00 p.m. and on 10/21/23 from 4:09 a.m. to 10:48 a.m. Additionally, Patient #7's breathing, circulation, range of motion and pain was not assessed on 10/21/23 from 6:00 a.m. to 10:48 a.m., at which time the restraints were discontinued.

This was in contrast to the Restraint and Seclusion policy which read, at least every 15 minutes, staff should have monitored a restrained patient for circulation, airway, and that physical needs were met. The RN should have monitored every two hours, or more often, as indicated by the individual patient's medical needs and health status.

iv. On 7/3/23 Patient #8 presented to the facility after he was bucked off a horse. Review of the non-violent restraint flowsheets revealed restraints were first documented on 7/5/23 at 8:00 a.m. A restraint order was not placed by the provider until 7/7/23 at 2:33 a.m., almost two days later.

This was in contrast to the Restraint and Seclusion policy which read, an order for restraint use should have been obtained when the application of restraint(s) was deemed necessary. The order for restraint use must have been placed at the start of a new restraint episode, this included re-initiation of previously applied restraints.

v. On 10/20/23 Patient #9 was admitted on 10/20/23 for trauma and rhabdomyolysis. A review of the non-violent restraint flowsheets revealed bilateral wrist restraints were placed on the patient on 10/23/23 at 1:45 p.m. for safety and to prevent the removal of equipment. On 10/24/23 at 10:00 a.m. the non-violent restraint flowsheet revealed staff removed the bilateral wrist restraints and placed the patient in the Posey vest restraint. Patient #9 was placed into a chair with the Posey vest secured. There was no evidence of the clinical justification for why the patient was placed in a Posey vest.

A RN note at 7:29 p.m. read the patient was seen sitting in his chair with the Posey vest securely tied. Ten minutes later the RN responded to a crash and found the patient on the floor and it appeared the patient had slid out of his chair. Patient #9 was assisted back to bed and bilateral wrist restraints were applied for safety. The non-violent restraint flowsheets read, the clinical justification for the wrist restraints was to prevent the patient from pulling at lines.

vi. On 10/10/23 Patient #10 was admitted for heart failure (a condition that develops when your heart doesn't pump enough blood for your body's needs). On this day, the patient was placed in bilateral wrist restraints due to pulling on his foley catheter (a tube inserted to drain a patient's urine from their bladder). The patient continued to be restrained in two-point restraints until 11/14/23 when the right restraint was removed due to the patient's inability to move his right arm. A RN note revealed on 11/15/23 the patient fell out of bed and had an injury. After the fall, he was placed in bilateral wrist restraints again as well as placed in a Posey vest and the four side rails of the bed were raised. A provider note read these restraints were implemented to prevent a fall and keep the patient from pulling at lines. The patient remained in restraints until 11/30/23. Multiple provider notes throughout the patient's stay stated they wanted a sitter to observe the patient in order to remove the restraints, however, there was no evidence in the medical record this occurred and no reason as to why a sitter was not obtained.

Further review of Patient #10's medical record revealed, there were missing restraint orders from a provider while the patient was restrained.

a. On 10/13/23 at 5:13 p.m., a restraint order was placed for Patient #10. The duration of this order was for 24 hours. Another restraint order was not placed until 10/17/23 at 11:28 p.m., three days after the 10/13/23 restraint order had expired. Review of the non-violent restraint flowsheets revealed the patient was restrained from 10/14/23 at 5:13 p.m. to 10/17/23 at 11:28 p.m. without an active restraint order.

b. On 10/17/23 at 11:28 p.m. a restraint order was placed for Patient #10. The duration of this order was for 24 hours. Another restraint order was not placed until 10/20/23 at 7:45 a.m., approximately one and a half days after the 10/17/23 had expired. Review of the non-violent restraint flowsheets revealed the patient was restrained during the period without an active restraint order.

B. Interviews revealed inconsistencies between staff practices, facility leadership expectations, facility policies, and the Posey vest restraint IFUs
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i. On 11/30/23 at 8:10 a.m., an interview was conducted with registered nurse (RN) #1. RN #1 stated staff determined the need for restraint use through communication from staff members, followed by a written order by the provider. RN #1 stated patients needed restraints if they had dementia or confusion and were not redirectable. RN #1 stated staff tried to redirect, educate, and communicate with patients before restraints were used to prevent falls. RN #1 stated staff used wrist restraints to prevent patients from pulling at lines (treatment devices necessary for their care). RN #1 stated in-person sitters and cameras were also used to help keep patients safe. RN #1 stated camera use could not accommodate patients with language barriers because most staff in the camera room only spoke English.

This was in contrast to the medical record review of Patients #4 and #6 which revealed staff did not use the least restrictive measures such as cameras on patients before they strained patients.

ii. On 11/30/23 at 8:50 a.m., an interview was conducted with RN #2. RN #2 stated staff used non-violent restraints for confused patients and for patients who pulled at lines. RN #2 stated staff tried to reorient and educate patients before patients were restrained. RN #2 stated when staffing was adequate, staff used an in-person sitter to prevent patient falls. Staff used restraints on patients for fall prevention when a sitter was not available to sit with patients. RN #2 stated staff used cameras to keep patients from falling when in-person sitters were not available. RN #2 stated staff applied a Posey vest restraint to a patient if the patient tried to get out of bed.

iii. On 11/30/23 at 9:40 a.m., an interview was conducted with RN #3. RN #3 stated the decision to initiate restraints was determined by the team who cared for the patient. RN #3 stated staff used cameras on redirectable patients and escalated to an in-person sitter when a patient was less redirectable. RN #3 stated staff attempted other interventions such as education and communication before restraints were applied to the patient. RN #3 stated staff used Posey vest restraints on patients who had a high risk of falling and were not redirectable. RN #3 stated staff used wrist restraints on patients who pulled on lines, showed agitation, or had a high risk of falling.

iv. On 11/30/23 at 12:30 p.m., an interview was conducted with Director #4. Director #4 stated staff used restraints on patients who showed safety concerns such as pulling lines, were not redirectable for instructions, or patients with concerns of elopement. Director #4 stated staff were not to use restraints for fall prevention and before the survey was unaware of the Posey vest restraint IFUs which stated the Posey vest was to be used to prevent falls. Director #4 stated there was no facility policy that indicated the use of Posey vest restraints to mitigate falls.

The interview with Director #4 was in contrast to the medical record review of Patients #4, #6, #9, and #10 which revealed restraints were used as a method to prevent patient falls.