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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 STANDARD: 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 document review, the facility failed to ensure patients remained free from restraints except when the patient posed a risk of injury or harm to themselves or others. Furthermore, staff did not ensure mechanical restraints were discontinued once they were no longer necessary. The facility also failed to evaluate restraint episodes for appropriate use, assess and monitor chemically restrained patients, and ensure providers entered orders for chemical restraints. These failures had the potential to affect all patients at the facility.

Based on interviews and document review, the facility failed to ensure patients remained free from restraints except when the patient posed a risk of injury or harm to themselves or others. Furthermore, staff did not ensure mechanical restraints were discontinued once they were no longer necessary. The facility also failed to evaluate restraint episodes for appropriate use, assess and monitor chemically restrained patients, and ensure providers entered orders for chemical restraints. These failures had the potential to affect all patients at the facility.

Findings include:

The Patient Restraints and Seclusion policy read, all patients have the right to be free from restraint and seclusion, of any form imposed as a means of coercion, discipline, convenience, or retaliation by associates. Restraint and/or Seclusion may only be imposed to ensure the immediate physical safety of the patient, an associate, or others, may only be used for the time necessary to accomplish their purpose, and must be discontinued at the earliest possible time when criteria for release have been met. Restraint and/or Seclusion use is defined by intent rather than diagnosis or the type of device or mechanism employed and is specific to the patient's behavior. Restraint and/or Seclusion use within the hospital is limited to situations only after the least restrictive interventions and alternatives have been considered and are deemed ineffective.

The policy defined chemical restraint as a drug or medication used as an involuntary restriction to manage the patient's behavior or restrict the patient's freedom of movement and is not a standard treatment or dosage for the patient's condition. The order for a chemical restraint must be obtained from the responsible caregiver in order to administer the chemical restraint. If mechanical/physical restraint and chemical restraint are to be used at the same time, a separate order is required for each type of restraint. The elements required as part of a restraint order include the patient's name, the date and time of the order, the name of the responsible caregiver, the reason for restraint, and the type of restraint must also be indicated.

The Assessment, Monitoring, and Documentation of Restraints section read, assessment and monitoring of restrained patients, including taking vital signs and interpreting the relevance to the physical safety of the patient in restraint. For patients administered a Chemical Restraint, monitoring includes monitoring of pulse oximetry and/or ETCO2 capnography (end-tidal carbon dioxide, the amount of carbon dioxide in exhaled breath) along with assessment using a sedation score (RASS score) to monitor for over-sedation, and changes in the patient's condition, such as improved mental status and capacity to adhere to expected behaviors.

1. The facility failed to ensure staff did not restrain patients for the purposes of coercion, discipline, convenience, or behavior management. Additionally, the facility failed to ensure staff removed mechanical restraints when they were no longer necessary.

A. Document review revealed staff restrained Patient #2 when the patient did not actively pose a risk of harm to themselves or others. Medical record review also revealed 4-point locking restraints (restraints applied to both arms and legs) were used to manage the patient's behavior and as a form of discipline.

i. Medical record review revealed Patient #2, a 12-year-old, had remained in the emergency department (ED) from 10/12/24 to 12/30/24 while residential placement was coordinated.

ii. On 11/11/24 and 12/6/24, restraint safety events revealed Patient #2 was restrained when the patient did not actively pose a risk of harm to themselves or others.

a. A review of the restraint safety event entered on 11/11/24 at 10:04 p.m. revealed Patient #2 was mechanically and chemically restrained.

According to the report, at 10:04 p.m., Patient #2 left their ED room and went to the lobby. In the lobby, Patient #2 loudly expressed feeling disrespected and unheard by the ED staff. Security officer (Officer) #2 and ED charge nurse (Charge RN) #1 spoke with Patient #2 and instructed them to return to their ED room, but Patient #2 refused.

After Patient #2 refused to return to their ED room, RN #10 brought an ED trauma gurney to the lobby. Charge RN #1 informed Patient #2 they would be physically assisted onto the gurney and placed in 4-point locking restraints if the patient did not comply. When Patient #2 refused again, Charge RN #1 directed staff to assist Patient #2 to the gurney, mechanically restrain the patient, and transport Patient #2 back to their ED room. Once the patient was back in their ED room, staff held Patient #2 down while RN #4 administered 5 milligrams (mg) of Zyprexa (medication administered for its sedative effects when patients display aggression or severe behavioral disturbance) in the patient's left thigh.

b. A review of the safety event report entered on 12/6/24 at 10:05 p.m. revealed Patient #2 went to the lobby and refused to return to their ED room. When ED staff arrived in the lobby, Patient #2 stated they did not want to return to their room and felt trapped there. Charge RN #5 instructed Patient #2 to return to their room. Patient #2 refused and insisted they be allowed to sit on the bench in the lobby. Charge RN #5 repeatedly told Patient #2 to return to their room. In response, Patient #2 made derogatory statements toward the ED staff.

After Patient #2 refused to return to their room, Officer #2 recommended to Charge RN #5 that Patient #2 be placed in 4-point locking restraints due to their non-compliance. Charge RN #5 left the lobby and returned with a trauma gurney and 4-point locking restraints. Charge RN #5 instructed Patient #2 to return to their ED room. When Patient #2 refused, Charge RN #5 directed staff to physically restrain the patient, who became combative and shouted loudly.

Once security and medical staff transported Patient #2 back to their ED room, nursing staff administered 5 mg of Zyprexa as a chemical restraint to Patient #2's left arm while security staff held the patient down.

iii. Further medical record review revealed Patient #2 remained in 4-point locking restraints after they no longer posed a risk of harm to themselves or others.

a. The restraint documentation in Patient #2's medical record revealed that staff placed Patient #2 in 4-point locking restraints at 10:30 p.m. on 12/6/24. By 11:15 p.m., 45 minutes after staff restrained Patient #2, the patient's agitation subsided, and Patient #2 was calm due to the sedative effects of Zyprexa. Despite Patient #2 being calm and asleep, staff kept Patient #2 restrained for an additional hour and 10 minutes until 12:25 a.m. on 12/7/24.

These events contrasted with the patient restraint and seclusion policy. According to the policy, staff should have used restraints only to ensure the immediate physical safety of the patient or others and apply them only for the time necessary to accomplish their purpose. Staff were required to discontinue restraints as soon as the patient met the criteria for release. Furthermore, the policy read that all patients had the right to be free from restraint or any form of restraint imposed as a means of coercion, discipline, or convenience.

B. Interviews with staff revealed staff restrained Patient #2 despite the patient posing no risk of harm to themselves or others. Staff also kept the patient in 4-point locking restraints after the patient no longer posed a risk to themselves or others.

i. On 12/30/24 at 1:45 p.m., RN #10 stated staff informed Patient #2 they would apply 4-point locking restraints if the patient refused to return to their ED room. RN #10 stated Patient #2 had a history of becoming aggressive and combative, which led staff to apply the locking restraints when Patient #2 did not comply with instructions. However, RN #10 stated staff restrained Patient #2 even when the patient was not actively aggressive to ensure the patient returned to their ED room.

ii. On 1/8/25 at 3:33 p.m., an interview was conducted with ED Manager #3. ED Manager #3 stated staff should only restrain patients when they pose a danger to themselves or others. ED Manager #3 explained if the patient was not endangering themselves, other patients, or staff, staff should not have used restraints. After reviewing Patient #2's medical record with surveyors, ED Manager #3 identified the restraint episodes on 11/14/24 and 12/6/24 as situations where staff should not have restrained Patient #2.

ED Manager #3 stated patients who were sedated or sleeping no longer posed a threat to themselves or others and did not display behaviors requiring restraint use. ED Manager #3 further stated staff kept Patient #2 in locking restraints longer than needed on 12/6/24. ED Manager #3 stated staff should have released the locking restraints once Patient #2 no longer met the criteria for restraint.

2. Providers failed to enter a chemical restraint order for medications used to chemically restrain patients. Additionally, staff failed to monitor and assess chemically restrained patients per facility policy.

A. Medical record review revealed staff chemically restrained patients without providers placing orders for chemical restraint, and nursing staff failed to monitor or assess the oxygen level, sedation level, and breathing of these patients.

i. A review of Patient #2's medication and restraint orders from 11/11/24 to 12/29/24 revealed an order for chemical restraint was not entered even though Zyprexa was administered to Patient #2 as a chemical restraint. Additionally, after the patient was administered Zyprexa as a chemical restraint, nursing staff did not monitor Patient #2's oxygen level, sedation level, and breathing after the patient was administered Zyprexa as a chemical restraint. Examples include:

a. On 11/11/24, at 10:12 p.m., Patient #2 was placed in 4-point locking restraints and administered 5 mg of Zyprexa.

b. On 11/14/24, at 8:17 p.m., Patient #2 was placed in 4-point locking restraints and administered 5 mg of Zyprexa.

c. On 12/6/24 at 10:30 p.m., Patient #2 was placed in 4-point locking restraints and administered 5 mg of Zyprexa at 10:43 p.m.

d. On 12/22/24 at 4:50 p.m., Patient #2 was placed in 4-point locking restraints and administered 5 mg of Zyprexa.

e. On 12/24/24, Patient #2 was in 4-point locking restraints from 12:30 p.m. to 4:49 p.m. At 1:53 p.m., staff administered 10 mg of Zyprexa, and at 4:49 p.m., they administered an additional 5 mg.

f. On 12/29/24 at 1:45 p.m., Patient #2 was placed in 4-point locking restraints and administered 5 mg of Zyprexa.

ii. A review of Patient #3's medical record revealed at 8:18 a.m. on 12/6/24, 11-year-old Patient #3 was transported by ambulance to the hospital after attempting to physically assault their grandmother.

a. At 9:12 a.m., staff placed Patient #3 in 4-point locking restraints and administered 5 mg of Zyprexa as a chemical restraint after Patient #3 became agitated and attempted to strike a security officer.

Further review of Patient #3's medical record revealed Provider #7 ordered 4-point locking restraints for violent behavior and ordered Zyprexa to be given to the patient. However, Provider #7 did not order Zyprexa as a chemical restraint, even though Zyprexa was administered as a chemical restraint.

Additionally, nursing staff failed to assess and monitor Patient #3's oxygen level, sedation level, and breathing after Patient #3 was administered Zyprexa as a chemical restraint.

The medical record reviews of Patients #2 and #3 contrasted with the Patient Restraints and Seclusion policy, which read that restraint orders should have included the reason for restraint and specified the type of restraint to be used. Additionally, the policy read that medication administered to involuntarily manage the patient's behavior or restrict the patient's freedom of movement was a chemical restraint. Additionally, the patient's oxygen level, sedation level, and breathing were to be monitored when a chemical restraint was administered.

B. Interviews with staff revealed a chemical restraint order was required when patients were administered medications to manage violent or aggressive behavior. Additionally, interviews revealed the oxygen level, sedation level, and patient breathing should have been monitored for chemically restrained patients.

i. On 1/14/25 at 1:07 p.m., an interview was conducted with Medical Director (Director) #8. Director #8 stated medications administered to manage a patient's violent behavior and prevent the patient from harming themselves or others were considered a chemical restraint.

Director #8 stated a chemical restraint was the administration of medications with sedative effects to manage violent or aggressive behaviors. Director #8 further stated patients who were mechanically restrained and administered a chemical restraint should have had an order for both the chemical and mechanical restraints entered by the provider. Additionally, Director #8 stated the medical provider needed to specify the reason for administering a chemical restraint and the signs and symptoms justifying its administration. Director #8 further stated Zyprexa was used as a chemical restraint when administered to Patient #2 and Patient #3, and an order for chemical restraint should have been entered by the medical provider.

Director #8 stated excessive sedation and respiratory depression could occur when patients were chemically restrained, and patients were at risk of not being properly monitored and assessed by nursing staff when providers did not enter orders for chemical restraint correctly.

ii. On 1/14/25 at 11:06 a.m., an interview was conducted with RN #9. RN #9 stated chemical restraints were medications administered to stop aggressive or violent behavior and caused a sedative effect. RN #9 further stated an order for the use of chemical restraint was required by the patient's medical provider. RN #9 stated the patient's oxygen level, sedation level, and breathing needed to be monitored when patients were chemically restrained. RN #9 stated the oxygen level, sedation level, and breathing were monitored for chemically restrained patients to ensure the patient did not experience life-threatening respiratory depression due to oversedation.

3. The facility failed to audit all patient restraint episodes in accordance with the facility's expectations.

A. Document review

i. A review of the quarterly Regulatory Readiness meeting minutes between 10/2023 and 1/2025 revealed the emergency department failed to meet its target restraint audit rate of 100 percent (%).

a. In February of 2024, the restraint audit rate was 0%.

b. In June of 2024, the restraint audit rate was 23%.

c. In January of 2025, the restraint audit rate was 35%.

This contrasted with the Tracer Observation Form provided by the facility on 1/13/25, which stated all restraint episodes were to be audited. Additionally, upon request, the facility could not provide evidence of preventive measures, process improvement evaluations, or actionable measures implemented to address the lack of restraint audits performed.

B. Interviews

i. Interviews with leadership revealed a lack of quality oversight, as well as the facility's failure to perform patient restraint audits and implement interventions to prevent recurrence

a. On 1/8/25 at 3:33 p.m., an interview was conducted with ED Manager #3. ED Manager #3 stated they had not ensured all patient restraint episodes in the ED were reviewed. ED Manager #3 stated restraint use was supposed to be audited to ensure the use of restraints was required, patients were released when they were no longer a threat to themselves or others, and the patient was assessed according to the type of restraint implemented. Additionally, ED Manager #3 stated restraint should be used only when necessary, as the use of restraints could cause physical injuries, psychological harm, increased agitation, and even death when used.

b. On 1/13/25 at 12:50 p.m., Quality Director (Director) #6 was interviewed. Director #6 stated restraint episodes were audited to ensure the correct order for restraint was entered, the use of restraint was appropriate, and patient monitoring and assessment were performed according to the type of restraint used.

Director #6 stated the quality department had identified patient care units had failed to audit 100% of the restraint episodes since 10/2023. Director #6 further stated during the regulatory readiness meetings, patient care units, including the ED, were informed staff needed to audit all restraint episodes and received resources to ensure they performed the audits. However, Director #6 stated a corrective action plan had not formally been developed to address the issue.