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Based on review of medical record reviews, policy and procedures and staff interviews, it was determined that the facility failed to protect and promote the patient rights for two of four sampled patients ((Patient (P) #1 and P#2) when restraints were utilized without a physician's order.

Cross-reference A-0154 as it relates to a patient's right to be free from restraint or seclusion.

Based on review of medical record, policy and procedures and staff interviews, it was determined that the facility failed to protect and promote the patient rights for two of four sampled patients ((Patient (P) #1 and P#2) when restraints were utilized without a physician's order.

Findings included:

A medical record (MR) review revealed that P#1 arrived at the facility's emergency department (ED) by emergency medical services (EMS) on 4/29/22 with delirium (disturbance in consciousness, decline in mental function), alcohol withdrawal, and seizures. P#1's Glasgow Coma Scale (GCS) was 8 (severe coma) (GCS is a scoring system used to describe a person's level of consciousness; severe-GCS 8 or less; moderate-GCS 9-12; mild-GCS 13-15). Continued review of the record revealed that P#1 had history of alcohol abuse and withdrawal syndrome, falls, and laryngeal cancer. P#1's vital signs were: Temperature- 97.7 degrees Fahrenheit (normal was 96 to 99.1 degrees); Heart Rate- 134 beats per minute (normal was 60-100); Respiratory Rate-26 breaths per minute (normal was 12-20); Blood pressure-120/89 (normal was 100-120/60-80); and Oxygen Saturation- 30% (normal was 94-100%). P#1 was intubated (plastic tube inserted into trachea to assist breathing) in the ED and transferred to the facility's intensive care unit on 4/30/22 at 4:08 a.m.

A review of physician orders revealed an order for restraints entered on 4/29/22 at 10:52 p.m. for combativeness despite sedation.

Continued review of the record revealed that restraints were applied without corresponding physician orders during the following intervals:

6/11/22 from 11:59 p.m. through 6/12/22 at 6:55 a.m.
6/24/22 from 11:59 p.m. through 6/25/22 at 5:23 a.m.
7/12/22 from 9:00 a.m. through 7/12/22 at 8:00 p.m.
7/28/22 from 11:59 p.m. through 7/28/22 at 3:31 a.m.
8/23/22 from 6:25 a.m. through 2:53 p.m.

A review of the restraint flow sheets revealed that P#1 was reassessed every two hours by the registered nurse while restrained.

A review P#2's medical record revealed that he was admitted to the facility on 8/25/22 with Congestive Heart Failure exacerbation. Continued review of the record revealed that P#2 was restrained without a corresponding physician order on 8/28/22 from 11:59 p.m. through 8/29/22 at 9:46 a.m. Review of the restraint flowsheet revealed that P#2 was reassessed every two hours while restrained.


An interview was conducted on 9/6/22 at 3:50 p.m. with Registered Nurse (RN) BB in the Intermediate Care Unit (IMCU). RN BB stated that physician orders were required when patients needed restraints. RN BB explained that the restraint order should include the duration, type of restraint, and rationale for the restraint. RN BB explained that nurses were required to chart restraint assessments and visually assess patients every two hours. Mittens were considered a form of restraint at the facility. RN BB explained that nursing policies and interventions were the same for two or four-point restraints and each restraint point was assessed to ensure patient safety.


An interview was conducted on 9/7/2022 at 10:35 a.m. with Medical Doctor (AA). MD AA explained that P#1 had a diagnosis of delirium, fell due to alcohol abuse, and bled into his brain. The neurosurgeon (brain surgeon) saw P#1 because of intracranial hemorrhage (bleeding in the brain). P#1had a Percutaneous Endoscopic Gastrostomy (PEG) tube (a feeding tube inserted through the abdominal wall into the stomach) placed for feeding. MD AA said that P#1 had been agitated, combative, kicked nurses, and tried to pull out the feeding tube and had to be restrained for the staff and patients' safety. MD AA explained that medication adjustments were made in an attempt discontinue the restraints. He further explained that the risk and benefits of medication adjustments verses restraints were considered because some medications made P#1's agitation worse and affected his mental status. MD AA recalled that interventions such as re-orientation and sitters had not been successful with P#1. MD AA acknowledged that physical restraint orders could not be written as an as needed order and that the provider had to reassess patients within 24 hours and prior to renewal of restraints for non-violent behavior. Providers should consider non-restrictive interventions prior to renewing a restraint order. MD AA stated that restraints could be applied in emergency situations, but the provider was notified as soon as possible. MD AA acknowledged that it was uncommon for a patient to be restrained for eight hours without having a current physician order.


A telephone interview was conducted 9/7/22 at 11:16 a.m. with Charge Nurse (CN) EE. CN EE stated that he had been with the facility for six years. CN EE recalled that P#1 was admitted due to a seizure related to alcohol use and that P#1 had sustained a head injury. CN EE explained that P#1 had an altered mental status throughout the hospitalization that resulted in agitation, combative and abusive behavior toward staff. CN EE stated that P#1's behavior was a safety issue for staff that required prolonged use of physical restraints.

CN EE explained that staff were required to visually assess and document restraints every two hours and at handoff. Staff checked to ensure that restrained patients had adequate range of motion, bathroom use, feeding/drinking opportunities and safety maintained while restrained. Restraint orders were required to be renewed every 24 hours which was a shared responsibility between nursing and physician staff. CN EE explained that it would be uncommon for non-emergency restraints to be applied without an active restraint order or an order promptly received. CN EE stated that if a patient pulled out a feeding tube, the nursing staff and physician assessed for alternative medication routes. The IMCU did not conduct frequent interdisciplinary rounds like in the intensive care unit; but communication was made between staff and care team members.

An interview was conducted with CN GG on 9/7/22 at 12:12 p.m. CN GG recalled that P#1 had been at the IMCU for several months longer than most patients. CN GG recalled that P#1 was always agitated and combative. CN GG recalled that the staff attempted interventions other than restraints such as keeping the room dim, limiting television, and medications but he still needed restraints at times. CN GG recalled that if P#1 was not restrained, he had gotten out of bed and hit staff at times. CN GG recalled a time when P#1 had done well, and the restraints were discontinued. CN GG said that there was a time when P#1 did well without restraint, and during that time, restraint was discontinued. CN GG explained that P#1 would get out of his bed and hit people. Due to safety concerns, P#1 had to be restrained. Non-violent restraint orders were valid for 24 hours. The order could be renewed by the physician after the patient was reassessed by the physician. CN GG stated that it was unusual for patients to be restrained without an order.


A review of the facility's policy titled "Patient Rights and Responsibilities," RI-01-01, last reviewed 5/2013, revealed that the purpose of the policy was to define a process to delineate the rights and responsibilities that a patient had within the facility's health system. Continued review revealed that patients had a right to be free from the use of restraints and/or seclusion unless deemed clinically necessary.

A review of the facility's policy titled "Restraints and Seclusion," RI-40-01, last reviewed 7/21/21, revealed that the purpose of the policy was to ensure that restraints and seclusion were used safely, effectively, and in compliance with regulatory and accreditation guidelines. Furthermore, the policy's purpose was to define the processes used to protect the patient's health and safety and preserve their rights and dignity during the use of restraints and seclusion.

Continued review revealed that the policy defined a restraint as any manual method, physical, or mechanical device, material, or equipment which restricted freedom of movement that the patient could not easily remove. Restraint alternatives must be attempted unless a patient's behavior presented an immediate danger to self and others. Similarly, restraint and seclusion were only used when alternatives had been ineffective and the reason for restraint and seclusion had been evaluated. The risk benefit of restraint use must be assessed by a physician, advanced practice provider (such as a nurse practitioner or physician's assistant), or RN. As needed (PRN) or standing orders for restraint or seclusion were not permitted. Patient and family members must be educated on restraint alternatives, the reason for restraint and seclusion, and restraint release criteria.

The "Restraints and Seclusion," RI-40-01 documented direct care staff were required to complete education and competency training regarding the safe and proper use of restraints or seclusion before applying restraints, implementing seclusion, monitoring, assessing, or providing care for a patient in restraints or seclusion. Restraints must not be placed over broken skin, open wounds, surgical wounds, and body piercings. The electronic medical record or downtime forms were used to document the order, the evaluation, the assessment, and monitoring of the restrained patient. When a restraint was removed based upon the patient's reassessment, a new order was required for the reapplication of the restraint.

Continued review of the policy revealed that each episode of restraint or seclusion must be reviewed by a Nurse Manager or designated staff. Restraint orders must be reviewed along with policy adherence with restraint monitoring and assessment. It must be ensured that the order was signed, dated, timed, not PRN, safety and needs monitored, alternatives, and assessments are completed.

Types of restraints, in order from less to more restrictive were:
- Side rails that are used for the primary purpose of confining a patient to bed and cannot be released by the patient.
- Mittens
- Limb splint intended to immobilize the patient's limb.
- Soft wrist restraints
- Nylon restraint
- Enclosure bed