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The Hospital was out of compliance for the Condition of Participation for Patient Rights.

Findings included:

The Hospital failed to ensure for one (Patient #1) of 10 sampled patients, that physical restraints were identified, assessed and monitored as restraints to prevent harm.

Refer to TAG: A-0159, A -0166, A -0167.

Based on records reviewed and interviews, the Hospital failed to identify a physical hold as a restraint for one of ten patients (Patient #1), when his/her arms were physically restrained by Nurse #2 and the Security Guard. The Hospital failed to identify a "soft" limb restraint as a medical restraint, requiring a physician order for both restraints.

Findings include:

CMS defines a restraint as 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.

A. Review of the Nurses Note, dated 6/21/21 at 12:33 P.M., indicated Patient #1 continued to be consistently agitated, screaming, yelling, punching and biting self and attempting to remove his/her intravenous line. A Security Guard was at the bedside, the physician was notified, and he ordered intravenous Benadryl (a medication for sedation), and soft restraints were placed on Patient #1.

Review of the Nurses Note, dated 6/21/21 at 12:45 P.M., indicated Patient #1 had the soft restraints removed and he/she was able to verbally contract.

Interview with Nurse #1 on 9/7/21 at 9:50 A.M., and review of the Physician Orders indicated Patient #1 did not have a physician's order for the soft limb restraints, that were applied on 6/21/21.

B. Review of the Nurses Note, dated 6/22/21 at 4:16 A.M., indicated Patient #1 kept trying to jump off the bed. The Nurse and additional staff had to hold Patient #1 from jumping out of bed, he/she was progressively more disobedient and lashing out, striking the staff and was verbally abusive. The Physician was notified after 30 minutes of trying to redirect, Patient #1 was medicated for his/her safety. After Patient #1 was medicated (with Ativan an anti-anxiety and Benadryl a sedating medication), he/she continued trying to get out of bed, which resulted in staff having to hold Patient #1 until he/she settled down and was safe.

Review of Patient #1's Medication Administration Record, indicated on 6/22/21 at 3:34 A.M., he/she was administered Ativan 1 milligram (mg), a intramuscular injection and a Benadryl 50 mg, a intramuscular injection.

Review of Patient #1's Medical Record indicated there was no physician's order for a physical hold to restrain Patient #1.

Interview on 9/7/21 at 3:50 P.M., Nurse #2 said that Nurse #2 and the Security Guard held down Resident #1's arms for approximately ten minutes for the first hold, then again for two minutes for the second hold, when Patient #1 was attempting to get out of bed. Nurse #2 said he did not think these holds were restraints because Patient #1's legs were not also restrained.

Interview on 9/7/21 at 10:50 A.M., the Mental Health Unit Manager said that review of Nurse #2's note, dated 6/22/21, indicated these physical holds would be considered a restraint which would require a physician's order.

Interview on 9/7/21 at 1:00 P.M., the Quality Assurance Nurse said there were no Emergency Department policies or protocols for pediatric restraints for combative behaviors in the Emergency Department.

Based on records reviewed and interviews, the Hospital failed for one patient (Patient #1), in a sample of ten patients, to ensure that restraints were used in accordance with a written modification to the plan of care for assessing, monitoring and preventing harm to the patient. During the use of restraints, Patient #1 developed iatrogenic (hospital acquired) rhabdomyolysis (a condition which can be life-threatening from muscle breakdown), due to him/her struggling against being physically restrained in the Emergency Department.

Finding include:

The Hospital policy, titled Restraints or Seclusion for Violent or Self-Destructive Behavior, dated 6/19/20, indicated that to:

- Ensure consistent and appropriate use of restraints when patients are at risk for injury.

- A restraint is any manual or physical method or mechanical device that immobilizes or reduces the ability of a patient to move his or her arms, legs, body or head freely, or a medication used as a restriction to manage the patient's behavior or to restrict freedom of movement.

- In the event a physical restraint is deemed necessary, the Nurse will identify the patient's special needs and address these needs in a plan of care
.
- In vulnerable populations the effects and consequences of physical restraint use can cause multiple complications.

- Documentation of restraints for each episode of use include the plan of care.

The Face Sheet, indicated Patient #1, a pediatric patient, was sectioned 12 (an involuntary admission) to the Emergency Department for a mental health evaluation on 6/16/21 at 11:58 P.M and discharged on 6/22/21 at 5:32 P.M.

The Ambulance Run Sheet, dated 6/16/21, indicated Patient #1 was sectioned 12 after making suicide statements, was very agitated and wanted to die.

The Physician's Emergency Department Note, dated 6/17/21, indicated Patient #1 had been at a community transitions program (to help people with psychiatric conditions) for approximately 36 hours and was upset, Patient #1's behavior escalated with the recent relocation, and Patient #1 had been tearful, uncooperative and threatening to kill him/herself. Diagnosed with depression and a suicide risk.

The Physician's Emergency Note, dated 6/17/21 at 8:58 A.M., indicated Patient #1 became increasingly agitated, pacing, stating he/she wanted to leave. Patient #1 was unable to be directed to his/her room and punched and banged his head against the wall. Patient #1 continued to make statements that he/she just wanted to die, attempts at de-escalation were not successful, and Patient #1 was treated with Benadryl and Ativan intramuscular injections.

The Social Worker Note, dated 6/18/21, indicated Patient #1 has been boarding in the Emergency Department since 6/16/21, while inpatient bed searches had been conducted and exhausted.

The Physician's Emergency Note, dated 6/21/21, indicated the affiliate Hospital was unable to take Patient #1 to the Emergency Department due to their high patient volumes and discussion with another Physician indicated Patient #1 would not be appropriate for the Pediatric floor due to difficulty managing Patient #1 with his/her agitation.

Interview on 9/8/21 at 8:10 A.M., Nurse #3 said that there is a high number of pediatric psychiatry patients increasingly using the Emergency Department for boarding, which is not the appropriate environment for them without the needed Psychiatric Services to control their behaviors. Nurse #3 said Patient #1's continual behavioral outrages needed to be stabilized and it was horrible having Patient #1 in the Emergency Department without the needed psychiatric services to control his/her uncontrollable outbursts.

Review of the Nurses Note, dated 6/22/21 at 4:16 A.M., indicated Patient #1 kept trying to jump off the bed. The Nurse and additional staff had to hold Patient #1 from jumping out of bed, he/she was progressively more disobedient and lashing out, striking the staff and was verbally abusive. The Physician was notified after 30 minutes of trying to redirect, Patient #1 was medicated for his/her safety. After Patient #1 was medicated (with Ativan an anti-anxiety and Benadryl a sedating medication), he/she continued trying to get out of bed, which resulted in staff having to hold Patient #1 until he/she settled down and was safe.

Interview on 9/7/21 at 3:50 P.M., Nurse #2 said that a plan of care was not initiated for conducting physical holds and Nurse #2 thought the plan of care for restraints was the 15 minute monitoring sheets, but a plan of care was not initiated for physical holds or other restraints.

Review of the Nurses Note, dated 6/22/21 at 5:38 A.M., indicated Patient #1 tried to jump off the bed, when Patient #1 was told that this was not safe behavior, he/she escalated and needed to be restrained to the bed via patient bed holds. The Patient was unable to de-escalate and continued with outbursts with yelling, kicking and punching. After being medically restrained (medications at 3:34 A.M. Ativan and Benadryl), Patient #1 was still trying to jump out of bed and was still combative. A Security Guard and multiple Nurses were able to help Patient #1 become safe and calm.

Review of the Medical record indicated there was no care plan for restraints.

The Laboratory Work, dated 6/21/21 at 2:02 A.M., indicated Patient #1's creatine kinase level (an indicator of muscle damage as a result of rhabdomyolysis) was 1,682 units/Liter (U/L), which was elevated (normal 0 to 310).

The Physician's Note, dated 6/21/21, indicated Patient #1 had an elevated CK level, and was diagnosed with rhabdomyolysis, and the plan was to transfer to the community tertiary hospital.

The Laboratory Work, dated 6/21/21 at 8:15 A.M., indicated Patient #1's creatine kinase level had increased again to 2,167 U/L.

The Surveyor interviewed the Chief of the Emergency Department at 9:45 A.M. and the Chief of Child Psychiatry at the Affiliate Hospital at 12:38 P.M. on 9/03/21. The Director of the Emergency Department and Director of Child Psychiatry said Patient #1 developed rhabdomyolysis in the Emergency Department due to struggling against restraints.

Interview on 9/03/21 at 8:45 A.M., the Director of Quality Assurances that there was no plan of care for Resident #1 regarding restraints.

Review of the Physician's Emergency Department Notes for Patient #1 from 6/20/21, through 6/22/21, indicated the Emergency Department Physicians conducted a extensive search with direct communication with the Affiliate Hospital's Pediatric Emergency Room Physician, the Pediatric Hospitalist, and the bed manager on a number of occasions and outreach discussions with the nursing supervisor, determining that a bed was unavailable, and that a one to one sitter was unavailable on 6/21/21, and to reevaluate a possibly transfer on 6/22/21.

Based on records reviewed and interview, the Hospital failed for one patient (Patient #1) in a sample of 10 patients, to ensure the Emergency Department implemented the use of restraints in accordance with the Hospital's policy to ensure that the Patient #1 was assessed and monitored to prevent harm. During the usage of mechanical restraints, Patient #1 developed iatrogenic (hospital acquired) rhabdomyolysis (a condition which can be life-threatening from muscle breakdown), due to him/her struggling against being physically restrained.

The Hospital policy, titled Restraints or Seclusion for Violent or Self-Destructive Behavior, dated 6/19/20, indicated that:

- A restraint is any manual or physical method or mechanical device that immobilizes or reduces the ability of a patient to move his or her arms, legs, body or head freely or a medication used as a restriction to manage the patient's behavior or to restrict freedom of movement.

- Assessment of the patient during restraint usage will be conducted by staff in the application and monitoring of patients in restraint.

- The Nurse will conduct the assessment of ongoing need for and response to the restraint.

- Documentation of restraints for each episode of use included: patient's response to the restraint and assessment of the patient's mental status, need for nutrition, fluids, toileting, ambulation and skin care.

The first Seclusion and Restraint Flowsheet, which contained the Physicians order for restraints, was not dated (the date ordered was 6/18/21 according to the Sitters Observational Flow Sheet) and not timed when the order was written. The three restraints ordered at 8:00 A.M. were seclusion, chemical and mechanical. The time for when the mechanical restraint was discontinued was not documented. The behaviors requiring seclusion and restraint were due to Patient #1 trying to elope, self-harm behaviors, punching walls, head banging the wall, spitting and biting the staff. The Monitoring Sheet was not dated and indicated Patient #1 was restrained from 8:00 A.M. to 9:30 A.M.

The second Seclusion and Restraint Flowsheet, indicated the Physicians order for restraints, was not dated nor timed. A mechanical restraint was ordered at 4:20 P.M. and discontinued at 4:30 P.M. (the date ordered was 6/19/21 according to the Sitters Observational Flow Sheet and Nurses Note). The behaviors requiring restraint were Patient #1 hitting his/her head against the wall, spitting on staff, swearing and kicking, pulling own hair and yelling. The Monitoring Sheet for Patient #1's baseline was not documented, nor when the mechanical restraint was initiated or discontinued.

The Physician's Order, dated 6/17/21, indicated a constant companion with 1:1 supervision (the ratio of one patient to one staff member).

The Observation Flow Sheet for High Risk Patients, with a Constant Companion, indicated incomplete documentation regarding Patient #1's care on:

- 6/18/21 through 6/19/21 during the 11:00 P.M. to 7:00 A.M. shift

- 6/19/21 during the 7:00 A.M. to 3:00 P.M. shift

- 6/19/21 through 6/20/21 during the 11:00 P.M. to 7:00 A.M. shift

- 6/20/21 through 6/21/21 during the 11:00 P.M. to 7:00 A.M. shift

Interview on 9/03/21 at 3:30 P.M., the Director of Quality & Care Management said that Patient #1's medical record did not include the required nursing documentation.

The Hospital was out of compliance for the Condition of Participation: Quality Assessment & Performance Improvement Program (QAPI).

Findings included:

The Hospital failed to ensure for one patient (Patients #1) out of ten sampled patients, that Hospital QAPI activities
identified opportunities for improvement in the quality of care.. While boarding in the Emergency Department for six days Patient #1, who had a psychiatric illness with combative behaviors was not stabilized, nor admitted to an inpatient psychiatric bed. Patient #1 continued with threats to harm him/herself and others with behavioral outputs in the Emergency Department.

Refer to TAG: A-0283.

Based on records reviewed and interviews, the Hospital failed for one patient (Patient #1) of 10 sampled patients, to ensure a thorough investigation and to identify opportunities for improvement.

Findings include:

The Hospital Quality Management and Patient Safety Plan, dated 2021, indicated the mission in the delivery of care was to improve the health of the people in our communities every day with quality and compassion. One objective is to maintain a safe environment for patients and employees and to conduct pro-active assessment of high-risk activities related to patient safety, ensuring appropriate improvements are undertaken.

1. The Hospital failed to have a psychiatrist evaluate Patient #1 in the Emergency Department, in order to stabilize Patient #1's continuous combative behaviors with threats to harm himself and others, which occurred for six days while boarding in the Hospital Emergency Department. During the use of mechanical and chemical restraints, Patient #1 developed iatrogenic (hospital acquired) rhabdomyolysis (a condition which can be life-threatening from muscle breakdown), due to him/her struggling against being physically restrained in the Emergency Department.

The Social Worker Note, dated 6/18/21, indicated Patient #1 has been boarding in the Emergency Department since 6/16/21, while inpatient bed searches had been conducted and exhausted.

Review of the Physician's Emergency Department Notes for Patient #1 from 6/20/21, through 6/22/21, indicated the Emergency Department Physicians conducted a extensive search with direct communication with the Affiliate Hospital's Pediatric Emergency Room Physician, the Pediatric Hospitalist, and the bed manager on a number of occasions and outreach discussions with the nursing supervisor, determining that a bed was unavailable, and that a one to one sitter was unavailable on 6/21/21, and to reevaluate a possibly transfer on 6/22/21.

Interview at 7:15 A.M. on 9/3/2021 the Quality Director said the process for a new electronic consultations form was formalized to expedite pediatric psychiatry bed availability at their affiliate Hospital.

Interviews with Nurse #1 at 9:50 A.M. on 9/7/21 and Nurse #3 at 8:10 A.M. on 9/8/21, they said the volume of pediatric psychiatric patients with complex behavior needs is increasing in the Emergency Department and the issue is the availability of the right human resources in the right location. What is needed is the direct involvement of a Psychiatrist in the Emergency Department for assessing and stabilizing these pediatric psychiatric patients before a bed is available.

The Hospital's investigation did not address the lack of human resources with the sitters for the 1:1 needed for these pediatric psychiatric patients.

2. The Hospital failed to investigate and to identify a physical hold as a restraint in the Emergency Department for Patient #1, when his/her arms were physically restrained by Nurse #2 and the Security Guard. The Hospital failed to identify a "soft" limb restraint as a medical restraint, requiring a physician order for both restraints.

Interview on 9/7/21 at 1:00 P.M., the Quality Assurance Nurse said there were no Emergency Department policies or protocols for pediatric physical holds for combative behaviors in the Emergency Department.

Review of the Nurses Note, dated 6/22/21 at 4:16 A.M., indicated that Patient #1 kept trying to jump off his/her bed. The Nurse and additional staff had to hold Patient #1 from jumping out of bed, he/she was progressively more disobedient and lashing out, striking the staff and was verbally abusive. The Physician was notified after 30 minutes of trying to redirect, Patient #1 was medicated for his/her safety. After Patient #1 was medicated (with Ativan an anti-anxiety and Benadryl a sedating medication), he/she continued trying to get out of bed, which resulted in staff having to hold Patient #1 until he/she settled down and was safe.

Review of Patient #1's Medical Record indicated there was no physician's order for a physical hold to restrain Patient #1.

Interview on 9/7/21 at 3:50 P.M., Nurse #2 said that Nurse #2 and the Security Guard held down Resident #1's arms for approximately 10 minutes for the first hold, then again for two minutes for the second hold, when Patient #1 was attempting to get out of bed. Nurse #2 said he did not think these holds were restraints because his/her legs were not also restrained.

Interview on 9/7/21 at 10:50 A.M., the Mental Health Unit Manager said that review of Nurse #2's note, dated 6/22/21, indicated these physical holds would be considered a restraint which would require a physician's order.

Review of the Nurses Note, dated 6/21/21 at 12:33 P.M., indicated Patient #1 continued to be consistently agitated, screaming, yelling, punching and biting self and attempting to remove his/her intravenous line and soft restraints were placed on Resident #1.

Interview with Nurse #1 on 9/7/21 at 9:50 A.M., and review of the Physician Orders indicated Patient #1 did not have a physician's order for the soft limb restraints, that were applied on 6/21/21.

3. The Hospital failed to ensure that restraints for Patient #1 were used in accordance with a written modification to the plan of care for assessing, monitoring and preventing harm to the patient. During the use of restraints, Patient #1 developed iatrogenic rhabdomyolysis.

The Hospital policy, titled Restraints or Seclusion for Violent or Self-Destructive Behavior, dated 6/19/20, indicated that to in the event a physical restraint is deemed necessary, the Nurse will identify the patient's special needs and address these needs in a plan of care.
- In vulnerable populations, the effects and consequences of physical restraint use can cause multiple complications, document the use of restraints for each episode of use and include the plan of care.

The Surveyor interviewed the Chief of the Emergency Department at 9:45 A.M. and the Chief of Child Psychiatry at the Affiliate Hospital at 12:38 P.M. on 9/3/21. The Director of the Emergency Department and Director of Child Psychiatry said that Patient #1 developed rhabdomyolysis in the Emergency Department due to struggling against restraints.

Review of the Medical record indicated there was no care plan for restraints.

Review of the Nurses Note, dated 6/22/21 at 4:16 A.M., indicated Patient #1 kept trying to jump off the bed. The Nurse and additional staff had to hold Patient #1 from jumping out of bed, he/she was progressively more disobedient and lashing out, striking the staff and was verbally abusive. After Patient #1 was medicated (with Ativan an anti-anxiety and Benadryl a sedating medication), he/she continued trying to get out of bed, which resulted in staff having to hold Patient #1 until he/she settled down and was safe.

Interview on 9/7/21 at 3:50 P.M., Nurse #2 said a plan of care was not initiated for conducting physical holds, and Nurse #2 thought the plan of care for restraints was the 15 minute monitoring sheets, but a plan of care was not initiated for physical holds or other restraints on Patient #1.

Interview on 9/3/21 at 8:45, the Director of Quality Assurance said there was no plan of care for Resident #1's restraints in the Emergency Department.