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Based on the review of the facility's Governing Body Bylaws, medical records, an interview with the complainant, interviews with staff, review of the Ethic Line Case Report, and review of the facility's policies and procedures, it was determined that the Governing Body failed to ensure that the facility staff protected two of four sampled Patients (P) (P#1, P#2) from restraints without a physician's order. Additionally, the facility failed to monitor and reassess one of three sampled patients (P#3) in restraints every two hours.



Cross refer to A-0068 as it relates to the Governing Body's failure to ensure patients safety and freedom from restraints without clinical justification.

Based on the review of the facility's Governing Body Bylaws, medical records, an interview with the complainant, interviews with staff, review of the Ethic Line Case Report, and review of the facility's policies and procedures, it was determined that the Governing Body failed to ensure that the facility staff protected two of four sampled Patients (P) (P#1, P#2) from restraints without a physician's order. Additionally, the facility failed to monitor and reassess one of three sampled patients (P#3) in restraints every two hours.

Findings:

A review of the facility's document titled "Board of Trustees Bylaws" revealed that the primary responsibility and goal of the Board of Trustees was to further the role and purpose of the Hospital by providing oversight of the Hospital and advice to the corporation and the Board of Directors. Thereby they could fulfill the responsibilities to the patient population served by the Hospital by facilitating the establishment of policies, maintaining quality patient care, and providing institutional management and planning, all in a manner responsive to the community's needs.

A review of Patient (P) #1's medical record revealed that P#1 presented to the facility via Emergency Medical Services (EMS) on 8/5/21 at 7:02 p.m. after he was found staggering down major roads and highways, endangering himself and others. P#1 had multiple hospital visits related to wandering and a history of dementia (loss of memory, language, problem-solving, and other thinking abilities that are severe enough to interfere with daily life). P#1 was found to be impulsive at the facility's ED, attempting to elope multiple times. P#1 was admitted to the facility for dementia evaluation and to ensure safe disposition. Social services and psychiatric consultations were ordered.

A Psychiatric Consultation Note, dated 8/9/21, revealed that P#1 was in an advanced stage of dementia. P #1 did not engage in any conversation with staff and was somewhat agitated. P#1 was placed on Namenda (medication for treating dementia) and Seroquel (antipsychotic used to treat mania, mood disorders, and depression). P#1 was noted to be awaiting long-term placement.

A review of the facility's Patient Order List revealed the following.

A restraints order was active on 10/14/21 at 1:35 p.m. The order expired on 10/15/21 at 1:34 p.m. A review of the Clinical Documentation Record failed to reveal that P#1 was reassessed at least every two hours.

A restraints order was active on 1/9/22 at 10:03 a.m. The order expired on 1/9/22 at 2:02 p.m.
A review of the facility's restraint documentation revealed that a soft non-violent, all extremities restraint was initiated at 10:14 a.m. Further review revealed that at 7:49 p.m., P#1 was in a soft all extremities restraint. A review of a Nurse's Note dated 1/9/22 at 9:15 p.m. revealed that RN JJ documented P#1 was in a 4-point restraint during bedside hand-off at 7:50 p.m. Further review of the medical record failed to reveal a renewal restraint order by the provider on 1/9/22 from 2:02 p.m. through 7:50 p.m. for P#1.

A continued review of the facility's restraint documentation revealed that P#1 was on a soft bilateral upper extremity restraint from 2/10/22 at 9:00 a.m. to 7:30 p.m. RN JJ documented in the nurse notes that P#1's bilateral wrist was angry red. Additionally, RN JJ noted a deep indentation around P#1's wrist. No documentation was noted on notifying the physician of the injury.

A review of the facility's clinical documentation record, dated 2/15/22, revealed that at 3:45 p.m., the occupational therapist noted that upon entry to P#1's room, P#1 had a soft restraint on his right wrist and was lying on his right side in the bed. The therapist noted that P#1's pants and bed were wet. The therapist documented that RN KK entered P#1's room to give P#1 his medicine. RN KK said P#1 did not require soft restraint donned on him on this day. The facility failed to explore less restrictive alternatives instead of placing P#1 in restraints.

On 2/15 at 7:30 p.m. RN JJ documented in the Nurse Note that P#1 was in bed with his left arm in soft wrist restraint secured to the bed frame, and no physician order was noted. RN JJ documented that RN KK said P#1 would come out of his room at times, especially when medication pass was in progress, so restraint was used temporarily. RN JJ documented that P#1's wrist was reddened with indented skin. RN JJ documented removing restraint. A review of the physician orders failed to reveal a restraint order at any time on 2/15/22 for P#1.

A review of Patient (P) #2 medical record revealed that P#2 was admitted to the facility on 1/19/22. P#2 had an altered mental status and a medical history of diabetes (high blood sugar) and hypertension (high blood pressure).

A review of the patient order list included the following:

A restraints order was active on 1/19/22 at 10:06 p.m. The order expired on 1/20/22 at 10:06 p.m.

A restraint order was active on 1/21/22 at 12:25 a.m. The order expired on 1/22/22 at 12:25 a.m.
Detailed review P#2's record failed to reveal a restraint order for 2 hours between 1/20/22 at 10:06 p.m. to 1/21/22 at 12:25 a.m.

A review of Patient (P) #3 medical record revealed that P#3 was admitted at the facility on 1/30/22 at 10:01 a.m. P#3 had an admission diagnosis of Chronic Obstructive Pulmonary Disease (COPD), cough, and COVID19.

A review of the clinical documentation record failed to reveal two-hour restraint documentation for the following days:

2/24/22 from 6:00 a.m. to 8:00 p.m., 2/25/22 from 6:00 a.m. to 10:00 a.m. 2/25/22 from 4:00 p.m. to 8:00 p.m., 2/26/22 from 6:00 p.m. to 12:15 a.m. 2/26/22 from 2:15 p.m. to 8:00 p.m., 2/27/22 from 4:00 p.m. to 8:00 p.m.

An interview took place in the conference room with the Vice President Quality (VPQ) DD and Patient Safety Officer (PSO) GG. VPQ DD stated that on 2/25/22, the Ethics Compliance Officer (ECO) BB held a meeting with some of the facility's staff because ECO BB was investigating an ethics complaint he received. VPQ DD said from her understanding the complaint was about a patient who had been at the facility for over 200 days, and the facility had been trying to discharge him to a long-term facility. VPQ DD said the complainant was anonymous, but staff submitted the complaint. VPQ DD stated the staff member was concerned that the facility was not the best place for P#1 because P#1's cognitive ability was deteriorating. VPQ DD said the staff didn't like the medication that the provider ordered, and the patient had been in restraint during the course of the stay. VPQ DD said the staff member questioned the necessity of the restraints. VPQ DD stated the investigation was still ongoing and that ECO BB (Ethics Compliance Officer) would be the best to discuss the investigation.

An interview was conducted with the Ethics Compliance Officer (ECO) BB on 3/2/22 at 9:12 a.m. ECO BB explained that he received a complaint about P#1. ECO BB stated that P#1 had been admitted to the facility for a long time. P#1 had dementia and the facility had trouble providing a safe discharge. ECO BB said P#1 needed to go to a skilled nursing facility but had no guardian or funding. ECO BB said P#1's aunt was his only relative, and she could not care for P#1. ECO BB stated the facility had started processing P#1's paperwork to get his guardianship. ECO BB said after receiving the complaint report on 2/23/22, he began investigating and had a meeting on 2/25/22 with the Patient Safety Officer (PSO) GG, Unit Director (Dir) CC, Chief Nursing Officer (CNO) HH, Unit Manager (Mg) II. ECO BB said they reviewed P#1's medical record and found a note written by Registered Nurse (RN) JJ alleging P#1 was restrained without a physician's order. ECO BB stated that RN JJ had been very attached to P#1, and she inquired of the leadership to take on guardianship of P#1. ECO BB said he discussed this with corporate legal, and they said if there were no monetary gain, it would be between RN JJ and the court. ECO BB said he didn't know if RN JJ followed up with being P#1's guardian. ECO BB said while investigating the allegation; it was identified that the Patient Care Technician (PCT) FF had used a single restraint to keep P#1 in the room when he cleaned P#1's room. ECO BB said PCT FF was counseled. ECO BB stated the investigation was still ongoing. Once the investigation was completed, ECO BB would have a final report and present the case to the Governing Board.

An interview took place with Hospitalist (MD) AA on 3/2/22 at 10:08 a.m. MD AA acknowledged he was aware of P#1 being a patient the facility. MD AA stated P#1 was admitted to the facility with a history of dementia. P#1 had been at the facility for close to six months. MD AA said, for the most part, P#1 had been medically stable, but the facility had been having difficulty finding a placement for him. MD AA said P#1 was nonverbal and wandered around the hallway. MD AA said P#1 was easily redirected, but sometimes he did not listen to verbal redirections. MD AA said that on 2/9/22, P#1 was diagnosed with COVID-19, MD AA ordered a non-violent restraint for P#1 due to infection control because P#1 would not stay in his room. MD AA said that most of the time, even though P#1 had a restraint order, he was not restrained but rather made to stay in his room with the door closed. MD AA said that the nurses would reassess patients every two hours and determine if there was still a need for restraint. MD AA stated that he was unaware of P#1 being restrained without a physician order. MD AA said nurses were always proactive about getting an order before restraining a patient, and they sometimes called in the middle of the night to get a restraining order.

An interview was conducted with Registered Nurse (RN) EE on 3/2/22 at 10:28 a.m. RN EE said he had been working at the facility for eight months. RN EE said he recalled P#1 because he had dementia, was non-verbal, dependent on others, and wandered a lot. RN EE said P#1 was recently restrained for infection control because P#1 had COVID. RN EE said the morning of 1/9/22, he went to P#1's room to give him some medication and saw that P#1 had picked up a food tray belonging to another patient. RN EE said P#1 was putting the food in his mouth and seemed to be choking. RN EE said he performed the Heimlich maneuver (first-aid procedure for dislodging an obstruction from a person's windpipe). RN EE explained that he checked P#1's vital signs and realized his oxygen saturation was low. RN EE said he called the Rapid Response Team, suctioned P#1 to get the food out of his mouth and placed a nasal cannula to keep his oxygen saturation up. RN EE said P#1 kept pulling off the nasal cannula. The physician ordered a violent restraint order for P#1. RN EE said he was under the impression that the order was a non-violent restraint for 24 hours, rather than a violent restraint for 4 hours (10:00 a.m. to 2:00 p.m.). RN EE said when he recognized the error, he stopped the restraint at 7:00 p.m. RN EE said P#1 wasn't combative; therefore, he thought it was a non-violent restraint that was ordered. RN EE said he notified the Unit Director once he realized the error. RN EE said he was unaware of any other incidents when P#1 was on restraint without a physician's order. RN EE said he did not provide care for P#1 when P#1 had COVID. RN EE stated he was not aware that P#1 was restrained during this time. RN EE said nurses were supposed to reassess the need for restraints and notify a doctor if they deemed it safe to discontinue the restraints.

An interview was conducted with Unit Director (UD) CC on 3/2/22 at 10:45 a.m. UD CC explained that P#1 had been on the unit for seven months. P#1 had dementia with no family, and the case manager had been working hard to get him placed. UD CC stated they located a relative of P#1s, but the relative also had dementia and needed supervision. UD CC said the facility had been working hard to obtain guardianship and funding for P#1. UD CC stated she was aware of two incidents in which P#1 was restrained. UD CC said that on 1/9/22 at 8:07 p.m., she received a text message from RN EE that P#1 was placed on a violent soft wrist restraint by the physician because P#1 was trying to remove his nasal cannula. However, RN EE thought it was a non-violent restraint, so it was not discontinued after four hours. UD CC said once the nurses were aware of the wrong order, they took P#1 of the restraint. UD CC said RN EE notified her. UD CC stated she provided some education to staff. UD CC said the second incident took place on 2/9/22. P#1 was diagnosed with COVID the day earlier, and during the multidisciplinary rounds, they discussed what to do with the safety of staff and other patients. UD CC said they decided to move P#1 to a negative pressure room and tried putting an N95 mask (face mask that filters airborne particles) on him, but he kept taking off the mask. UD CC said the physician ordered a restraint to keep him from leaving his room. UD CC stated that staff would request an order during the day and discontinue it at night because he was more cooperative. UD CC said the nurses would reassess P#1 every two hours and release his arm for a range of motion. UD CC stated an incident was brought to her attention on 2/22/22. P#1 was found with restraint on his hand. UD CC said that during the bedside shift report, RN JJ noticed a single soft wrist restraint on P#1 and asked RN KK why P#1 was restrained without a physician order. RN KK said PCT FF must have placed P#1 in restraint because he was having difficulty keeping P#1 in his room. PCT FF told RN KK that because P#1 was incontinent when PCT FF tried to clean or feed P#1, and he would not sit still, PCT FF would place a restraint on P#1to feed him and then remove it afterward. UD CC said RN KK educated PCT FF and removed the restraint. UD CC stated her expectation was that staff would notify her or the manager in real-time about such an incident. But, in real-time, staff did not inform her or the manager to address the situation. UD CC said she was unaware of any other time when a patient was restrained without a physician's order. UD CC said the staff had been treating P#1 as a family, and there are several occasions they will buy him candy.

An interview was conducted with Registered Nurse (RN) JJ on 3/7/22 at 9:31 a.m. RN JJ stated she recalled P#1. RN JJ said P#1 was admitted to the facility in August and had deteriorated since his stay at the facility. RN JJ said P#1 could talk, toilet, and feed himself when he was admitted to the facility, but he no longer could do any of those things. RN JJ said she did not believe that P#1's history of dementia caused his deterioration, but rather because the facility would constantly tell P#1 to stay in his room and socially isolate himself. RN JJ said the facility had constantly sedated P#1 by putting him on antipsychotics (Depakote three times a day, Prozac, Ativan, Benadryl, and melatonin). RN JJ said these medications did not help P#1, only kept him sedated. In addition, RN JJ said the facility did not feed P#1 enough, and because P#1 had been homeless, he was not used to getting food regularly. RN JJ stated that she arrived at the facility on 1/9/22 to start her night shift. RN JJ explained that she went to P#1's room at 7:50 p.m. and found that P#1's arms and legs had been restrained (4- point). RN JJ asked RN EE why P#1 was placed in a four-point restraint without a sitter. RN EE said P#1 had gotten into someone's else food and almost choked on some chicken, so the doctor was notified, and P#1 was restrained. RN JJ said she immediately took the restraint off and told RN EE that he should have known that the restraint order was only for four hours. RN JJ said when UD CC was notified about the incident, rather than acknowledging the error, they tried to change the documentation and wrote the wrong time. RN JJ said it was unfair for P#1 to be punished because he was hungry and trying to eat hastily. RN JJ stated that on 2/9/22, P#1 was put in a four-point restraint due to P#1 having COVID. RN JJ said when she began her shift, she removed the restraint, fed, and changed P#1's diaper. RN JJ said if P#1was wet or hungry, he wandered, but he was a happy camper if he was dry and fed. RN JJ said P#1 did not come out of his room throughout her shift. RN JJ said P#1's legs and arms were restrained, and he had no sitter with him. RN JJ said when she asked UD CC if they could get P#1 a sitter because a sitter was the least restrictive measure, UD CC said the facility did not have enough staffing for a sitter. In addition, RN JJ said she observed the facility getting a sitter for a different patient that made a suicide threat jokingly. Still, the facility would not get a sitter for P#1 because he was nonverbal and had no funding. RN JJ said on 2/10/22 when she came to work, she found that P#1 had both wrists tied, and they were red with indentations. RN JJ said P#1 was restraint every shift during the day until 2/14/22, and every time she came in for her shift at night, she would remove the restraint. RN JJ said that when she told UD CC that P#1's wrist was always red and indented from the restraint, UD CC would tell her that P#1 was pulling on the restraint; however, she never saw P#1 pull the restraint. RN JJ said on 2/15/22, when she came to work, she went to P#1's room to feed him around 7:30 p.m. and observed P#1's left arm was restrained. RN JJ said P#1 looked so depressed. RN JJ said she removed the restraint and asked RN LL why P#1 was restrained. RN JJ explained that RN LL said she restrained P#1 because she had to pass medications to other patients and finish her shift without having to watch P#1. RN JJ said the facility started short-staffing the unit by sending some staff to the emergency department. RN JJ said she knew the facility could hire a sitter for P#1, but because he had no money, they probably did not want to get him a sitter. RN JJ said she believed the facility would retaliate against her because she was vocal and concerned that P#1 was illegally restrained. RN JJ said she would have done the same to any other patient. RN JJ said she had to speak up when she observed something wrong and be the voice for her patients. RN JJ said she had requested from the facility to be P#1's guardian.

An interview was conducted with Patient Care Technician (PCT) FF on 3/3/22 at 10:24 a.m.. PCT FF said P#1 was previously considered a 1013 patient (involuntary treatment). PCT FF said P#1 could feed himself, lay in his bed, and walk around, but he progressively got worse, and staff had to start feeding him. PCT FF said it had gotten to the point that staff had to do everything for P#1. A few weeks ago, PCT FF said P#1 was on contact precautions; however, he was walking around the unit without a mask on, so the provider ordered that P#1 be restrained. PCT FF said each time the physician ordered P#1 to be restrained, RN JJ would discontinue the order, so the provider got frustrated and would not put the order in again. PCT FF said P#1 had anxiety and would not sit still when PCT FF tried to feed him, so he would put a restraint on P#1 for about 15 minutes to feed him. PCT FF said he did that about two to three times when he cared for P#1 and also after the restraint order had been discontinued. PCT FF said he was aware, per the facility policies, that only the nurses were allowed to restrain patients. PCT FF said he had mandatory annual training on restraint.

An interview was conducted with RN KK on 3/3/22 at 2:07 p.m. RN KK stated she recalled P#1 because P#1 had dementia with behavioral concerns and wandered around the hallway. RN LL stated the facility tried to keep him safe from wandering off by putting a name tag and room number on P#1. RN KK said P#1 was incontinent, and his total care was dependent on staff. RN KK said P#1 recently had a cough, and there were concerns he may have contacted COVID. P#1 tested positive for COVID and was placed on an isolation process. RN KK said P#1 did not need extensive COVID medication but was on quarantine for ten days. RN KK said there was a particular day, though she could not recall the date, she came into work and received a shift report. RN KK was informed P#1 would not be kept on a restraint because there was no order, and the facility was avoiding restraint. RN KK said she went to P#1's room around midday to give P#1 his medication and saw P#1 was restrained to the bed. RN KK said she released P#1 and asked who placed the restraint. RN KK said she was told that PCT FF put the restraint on P#1 because PCT FF was trying to clean P#1. RN KK said she educated P#1 and told PCT FF that P#1 could not be restrained without a physician's order. RN KK said throughout the rest of the day, P#1 was not restrained. RN KK stated she went to P#1's room to do a shift report with RN JJ at shift change and found P#1 was in restraint. RN KK stated she asked RN JJ who put the restraint on P#1. RN KK said she was unsure who placed P#1 on restraint but informed RN JJ that P#1 had no order to be restrained.

A review of the facility's "Ethic Line Case Report" revealed concerns of quality of patient care expressed by the complainant to the facility on behalf of P#1. Further review revealed that the Ethics Compliance Officer (ECO) BB held a meeting with the Patient Safety Officer (PSO) GG, Unit Director (Dir) CC, Chief Nursing Officer (CNO) HH, and Unit Manager (Mg) II to discuss the complaint. A detailed review revealed that the investigation was ongoing.

A review of the facility's policy titled "Patient Restraint/Seclusion Policy," last reviewed 1/21, revealed that the policy's purpose was to protect the dignity and safety of inpatient, outpatient, staff, and visitors through a safe restraint process. Restraint or seclusion use would be limited to clinically justified situations, and the least restrictive restraint would be used to reduce and ultimately eliminate the use of restraints or seclusions.

The following process would be observed:

1. The Registered Nurse (RN) would perform an assessment for risk for restraint or seclusion when a patient exhibited behavior that may place the patient at risk for restraint or seclusion.

2. An order for restraint or seclusion must be obtained from a physician or other licensed practitioner who was acting within their state's Scope of Practice, authorized by state law as having authority for ordering restraints, and was responsible for the care of the patient prior to the application of restraint or seclusion.

3.The order must specify clinical justification for the restraint or seclusion, the date and time ordered, the duration of use, the type of restraint to be used, and behavior-based criteria for release.

Order for Restraint with Non-Violent or Non-Self-Destructive Behavior
1. Initial restraint order: An initial order for restraint must not exceed 24 hours, must specify clinical justification for the restraint, the date and time ordered, the duration of use, the type of restraint, and behavior-based criteria for release.

2. An initial order for restraint must not exceed 24 hours. The physician or licensed practitioner may order a shorter period of time.

3. Staff would assess, monitor, and re-evaluate the patient regularly and release the patient from restraint when criteria for release were met.

a. To continue restraint use beyond the initial order duration, the physician or other licensed practitioner must see the patient, perform a clinical assessment and determine if continuation of restraint was necessary.
b. Renewal restraint order: If a reassessment indicated an ongoing need for restraint, a renewal restraint order must be entered into the medical record within 24 hours of the initial restraint order. Subsequent renewal orders would be entered for each calendar day by the physician or other licensed practitioner, authorized by state law to order restraints.

Order for Restraint with Violent or Self-Destructive Behavior

1. Orders for restraint or seclusion must be time-limited and specify clinical justification for the restraint or seclusion, the date and time ordered, duration of restraint or seclusion use, the type of restraint, and behavior-based criteria for release. Orders for restraint or seclusion must not exceed four hours for adults aged 18 years and older.

2. The time frames specified were maximums. A physician or other licensed practitioner, authorized by state law, may order a shorter period of time.

3. Staff would assess, monitor, and re-evaluate the patient regularly and release the patient from restraint or seclusion when criteria for release were met.

a. To continue restraint or seclusion beyond the initial order duration, the RN would determine that the patient was not ready for release and call the ordering physician or licensed practitioner, authorized by state law, to order restraints and obtain a renewal order.

b. Renewal orders for restraint/seclusion could not exceed four hours for adults aged 18 years or older.

Monitoring the Patient in Restraints or Seclusion

1. Patients were assessed by an RN immediately after restraints or seclusion was initiated to assure safe application/initiation of the restraint or seclusion.
2. An RN would assess the patient at least every two hours.

Discontinuation of Restraint or Seclusion

1. The patient in restraint or seclusion would be evaluated frequently, and the intervention would be ended at the earliest possible time.

a. The time-limited order did not require that the application be continued for the entire period.

b. When an RN determined that the patient met the criteria for release in the restraint order, restraints or seclusion was discontinued by staff with demonstrated competence.

c. Once restraints or seclusion was discontinued, a new order for restraint or seclusion was required to reapply or reinitiate.

d. A temporary, directly supervised release that occurred during patient care (e.g., toileting, feeding, or range of motion) was not considered discontinuation of restraint or seclusion.

A review of the facility's policy titled "Patient Right and Responsibility," last reviewed 2/15, revealed that patients had the right to receive individualized care that fostered the patient's comfort and dignity and would be delivered in a setting that is free from abuse, discrimination, and harassment.
The facility failed to ensure that their policies and procedures were followed as evidenced by failing to protect #1's. The facility failed to ensure that during patient #1's hospitalization their policies and procedures were followed as evidenced by failing to protect his dignity, right to receive care in a safe setting and his safety through a safe restraint process. This multi-system failure validated that on multiple occasions the facility failed to document clinical justification for the use restraints; failed to obtain orders for restraints; failed to notify the Physician of the injuries the restraint was causing to the patient's wrist; failure to provide/document how the injuries to the wrists were treated; inaccurately restrained the patient at times by only restraining one limb was at the convenience of the staff for passing medications, feeding the patient, clean the patient's room. Additionally, patient #1 was restrained because he tested positive for COVID 19 which resulted in inappropriate Infection Control Precautions for the patient and other patients on the unit.

Based on the review of medical records, interview with the complainant, staff interviews, policies, and procedures it was determined that the facility staff failed to protect two of 4 sampled Patients (P) (#1,2) from restraints without a physician orders and clinical justifications. Additionally, the facility failed to monitor and reassess one of 3 sampled patients in restraint (P#3) at least every two hours.

Cross refer to A-0145 as it relates to the facility' s failure to ensure that patients are free from abuse and harrassement

Based on the review of medical records, an interview with the complainant, interviews with staff, and review of the facility's policies and procedures, it was determined that the facility staff failed to protect two of four sampled Patients (P) (P#1, P#2) rights to be free from restraint without a physician order and clinical justification.

Findings:

A review of Patient (P) #1's medical record revealed that P#1 presented to the facility via Emergency Medical Services (EMS) on 8/5/21 at 7:02 p.m. after he was found staggering down major roads and highways, endangering himself and others. P#1 had multiple hospital visits related to wandering and a history of dementia (loss of memory, language, problem-solving, and other thinking abilities that are severe enough to interfere with daily life). P#1 was found to be impulsive at the facility's ED, attempting to elope multiple times. P#1 was admitted to the facility for dementia evaluation and to ensure safe disposition. Social services and psychiatric consultations were ordered.

A Psychiatric Consultation Note, dated 8/9/21, revealed that P#1 was in an advanced stage of dementia. P #1 did not engage in any conversation with staff and was somewhat agitated. P#1 was placed on Namenda (medication for treating dementia) and Seroquel (antipsychotic used to treat mania, mood disorders, and depression). P#1 was noted to be awaiting long-term placement.

A review of the facility's Patient Order List revealed the following.

A restraints order was active on 10/14/21 at 1:35 p.m. The order expired on 10/15/21 at 1:34 p.m.

A review of the Clinical Documentation Record failed to reveal that P#1 was reassessed at least every two hours.

A restraints order was active on 1/9/22 at 10:03 a.m. The order expired on 1/9/22 at 2:02 p.m.
A review of the facility's restraint documentation revealed that a soft non-violent, all extremities restraint was initiated at 10:14 a.m. Further review revealed that at 7:49 p.m., P#1 was in a soft all extremities restraint.

A review of a Nurse's Note dated 1/9/22 at 9:15 p.m. revealed that RN JJ documented P#1 was in a 4-point restraint during bedside hand-off at 7:50 p.m. Further review of the medical record failed to reveal a renewal restraint order by the provider on 1/9/22 from 2:02 p.m. through 7:50 p.m.

A continued review of the facility's restraint documentation revealed that P#1 was on a soft bilateral upper extremity restraint from 2/10/22 at 9:00 a.m. to 7:30 p.m. RN JJ documented in the nurse notes that P#1's bilateral wrist was angry red. Additionally, RN JJ noted a deep indentation around P#1's wrist.

A review of the facility's clinical documentation record, dated 2/15/22, revealed that at 3:45 p.m., the occupational therapist noted that upon entry to P#1's room, P#1 had a soft restraint on his right wrist and was lying on his right side in the bed. The therapist noted that P#1's pants and bed were wet. The therapist documented that RN KK entered P#1's room to give P#1 his medicine. RN KK said P#1 did not require soft restraint donned on him on this day.

On 2/15 at 7:30 p.m. RN JJ documented in the Nurse Note that P#1 was in bed with his left arm in soft wrist restraint secured to the bed frame, and no physician order was noted. RN JJ documented that RN KK said P#1 would come out of his room at times, especially when medication pass was in progress, so restraint was used temporarily. RN JJ documented that P#1's wrist was reddened with indented skin. RN JJ documented removing restraint. A review of the physician order failed to reveal a restraint order on 2/15/22 for P#1.

A review of Patient (P) #2 medical record revealed that P#2 was admitted to the facility on 1/19/22. P#2 had an altered mental status and a medical history of diabetes (high blood sugar) and hypertension (high blood pressure).

A review of the patient order list included the following:

A restraints order was active on 1/19/22 at 10:06 p.m. The order expired on 1/20/22 at 10:06 p.m.

A restraint order was active on 1/21/22 at 12:25 a.m. The order expired on 1/22/22 at 12:25 a.m.
Detailed review P#2's record failed to reveal a restraint order for 2 hours between 1/20/22 at 10:06 p.m. to 1/21/22 at 12:25 a.m.

An interview was conducted with Registered Nurse (RN) EE on 3/2/22 at 10:28 a.m. RN EE said he had been working at the facility for eight months. RN EE said he recalled P#1 because he had dementia, was non-verbal, dependent on others, and wandered a lot. RN EE said P#1 was recently restrained for infection control because P#1 had COVID. RN EE said the morning of 1/9/22, he went to P#1's room to give him some medication and saw that P#1 had picked up a food tray belonging to another patient. RN EE said P#1 was putting the food in his mouth and seemed to be choking. RN EE said he performed the Heimlich maneuver (first-aid procedure for dislodging an obstruction from a person's windpipe). RN EE explained that he checked P#1's vital signs and realized his oxygen saturation was low. RN EE said he called the Rapid Response Team, suctioned P#1 to get the food out of his mouth and placed a nasal cannula to keep his oxygen saturation up. RN EE said P#1 kept pulling off the nasal cannula. The physician ordered a violent restraint order for P#1. RN EE said he was under the impression that the order was a non-violent restraint for 24 hours, rather than a violent restraint for 4 hours (10:00 a.m. to 2:00 p.m.). RN EE said when he recognized the error, he stopped the restraint at 7:00 p.m. RN EE said P#1 wasn't combative; therefore, he thought it was a non-violent restraint that was ordered. RN EE said he notified the Unit Director once he realized the error. RN EE said he was unaware of any other incidents when P#1 was on restraint without a physician's order. RN EE said he did not provide care for P#1 when P#1 had COVID. RN EE stated he was not aware that P#1 was restrained during this time. RN EE said nurses were supposed to reassess the need for restraints and notify a doctor if they deemed it safe to discontinue the restraints.

An interview was conducted with Unit Director (UD) CC on 3/2/22 at 10:45 a.m. UD CC explained that P#1 had been on the unit for seven months. P#1 had dementia with no family, and the case manager had been working hard to get him placed. UD CC stated they located a relative of P#1s, but the relative also had dementia and needed supervision. UD CC said the facility had been working hard to obtain guardianship and funding for P#1. UD CC stated she was aware of two incidents in which P#1 was restrained. UD CC said that on 1/9/22 at 8:07 p.m., she received a text message from RN EE that P#1 was placed on a violent soft wrist restraint by the physician because P#1 was trying to remove his nasal cannula. However, RN EE thought it was a non-violent restraint, so it was not discontinued after four hours. UD CC said once the nurses were aware of the wrong order, they took P#1 of the restraint. UD CC said RN EE notified her. UD CC stated she provided some education to staff. UD CC said the second incident took place on 2/9/22. P#1 was diagnosed with COVID the day earlier, and during the multidisciplinary rounds, they discussed what to do with the safety of staff and other patients. UD CC said they decided to move P#1 to a negative pressure room and tried putting an N99 mask (face mask that filters airborne particles) on him, but he kept taking off the mask. UD CC said the physician ordered a restraint to keep him from leaving his room. UD CC stated that staff would request an order during the day and discontinue it at night because he was more cooperative. UD CC said the nurses would reassess P#1 every two hours and release his arm for a range of motion. UD CC stated an incident was brought to her attention on 2/22/22. P#1 was found with restraint on his hand. UD CC said that during the bedside shift report, RN JJ noticed a single soft wrist restraint on P#1 and asked RN KK why P#1 was restrained without a physician order. RN KK said PCT FF must have placed P#1 in restraint because he was having difficulty keeping P#1 in his room. PCT FF told RN KK that because P#1 was incontinent when PCT FF tried to clean or feed P#1, and he would not sit still, PCT FF would place a restraint on P#1to feed him and then remove it afterward. UD CC said RN KK educated PCT FF and removed the restraint. UD CC stated her expectation was that staff would notify her or the manager in real-time about such an incident. But, in real-time, staff did not inform her or the manager to address the situation. UD CC said she was unaware of any other time when a patient was restrained without a physician's order. UD CC said the staff had been treating P#1 as a family, and there are several occasions they will buy him candy.

An interview was conducted with Registered Nurse (RN) JJ on 3/7/22 at 9:31 a.m. RN JJ stated she recalled P#1. RN JJ said P#1 was admitted to the facility in August and had deteriorated since his stay at the facility. RN JJ said P#1 could talk, toilet, and feed himself when he was admitted to the facility, but he no longer could do any of those things. RN JJ said she did not believe that P#1's history of dementia caused his deterioration, but rather because the facility would constantly tell P#1 to stay in his room and socially isolate himself. RN JJ said the facility had constantly sedated P#1 by putting him on antipsychotics (Depakote three times a day, Prozac, Ativan, Benadryl, and melatonin). RN JJ said these medications did not help P#1, only kept him sedated. In addition, RN JJ said the facility did not feed P#1 enough, and because P#1 had been homeless, he was not used to getting food regularly. RN JJ stated that she arrived at the facility on 1/9/22 to start her night shift. RN JJ explained that she went to P#1's room at 7:50 p.m. and found that P#1's arms and legs had been restrained (4- point). RN JJ asked RN EE why P#1 was placed in a four-point restraint without a sitter. RN EE said P#1 had gotten into someone's else food and almost choked on some chicken, so the doctor was notified, and P#1 was restrained. RN JJ said she immediately took the restraint off and told RN EE that he should have known that the restraint order was only for four hours. RN JJ said when UD CC was notified about the incident, rather than acknowledging the error, they tried to change the documentation and wrote the wrong time. RN JJ said it was unfair for P#1 to be punished because he was hungry and trying to eat hastily. RN JJ stated that on 2/9/22, P#1 was put in a four-point restraint due to P#1 having COVID. RN JJ said when she began her shift, she removed the restraint, fed, and changed P#1's diaper. RN JJ said if P#1was wet or hungry, he wandered, but he was a happy camper if he was dry and fed. RN JJ said P#1 did not come out of his room throughout her shift. RN JJ said P#1's legs and arms were restrained, and he had no sitter with him. RN JJ said when she asked UD CC if they could get P#1 a sitter because a sitter was the least restrictive measure, UD CC said the facility did not have enough staffing for a sitter. In addition, RN JJ said she observed the facility getting a sitter for a different patient that made a suicide threat jokingly. Still, the facility would not get a sitter for P#1 because he was nonverbal and had no funding. RN JJ said on 2/10/22 when she came to work, she found that P#1 had both wrists tied, and they were red with indentations. RN JJ said P#1 was restraint every shift during the day until 2/14/22, and every time she came in for her shift at night, she would remove the restraint. RN JJ said that when she told UD CC that P#1's wrist was always red and indented from the restraint, UD CC would tell her that P#1 was pulling on the restraint; however, she never saw P#1 pull the restraint. RN JJ said on 2/15/22, when she came to work, she went to P#1's room to feed him around 7:30 p.m. and observed P#1's left arm was restrained. RN JJ said P#1 looked so depressed. RN JJ said she removed the restraint and asked RN LL why P#1 was restrained. RN JJ explained that RN LL said she restrained P#1 because she had to pass medications to other patients and finish her shift without having to watch P#1. RN JJ said the facility started short-staffing the unit by sending some staff to the emergency department. RN JJ said she knew the facility could hire a sitter for P#1, but because he had no money, they probably did not want to get him a sitter. RN JJ said she believed the facility would retaliate against her because she was vocal and concerned that P#1 was illegally restrained. RN JJ said she would have done the same to any other patient. RN JJ said she had to speak up when she observed something wrong and be the voice for her patients. RN JJ said she had requested from the facility to be P#1's guardian.

An interview was conducted with Patient Care Technician (PCT) FF on 3/3/22 at 10:24 a.m. PCT FF said P#1 had been at the facility since September. PCT FF said P#1 was previously considered a 1013 patient (involuntary treatment). PCT FF said P#1 could feed himself, lay in his bed, and walk around, but he progressively got worse, and staff had to start feeding him. PCT FF said it had gotten to the point that staff had to do everything for P#1. A few weeks ago, PCT FF said P#1 was on contact precautions; however, he was walking around the unit without a mask on, so the provider ordered that P#1 be restrained. PCT FF said each time the physician ordered P#1 to be restrained, RN JJ would discontinue the order, so the provider got frustrated and would not put the order in again. PCT FF said P#1 had anxiety and would not sit still when PCT FF tried to feed him, so he would put a restraint on P#1 for about 15 minutes to feed him. PCT FF said he did that about two to three times when he cared for P#1 and also after the restraint order had been discontinued. PCT FF said he was aware, per the facility policies, that only the nurses were allowed to restrain patients. PCT FF said he had mandatory annual training on restraint.

An interview was conducted with RN KK on 3/3/22 at 2:07 p.m. RN KK stated she recalled P#1 because P#1 had dementia with behavioral concerns and wandered around the hallway. RN LL stated the facility tried to keep him safe from wandering off by putting a name tag and room number on P#1. RN KK said P#1 was incontinent, and his total care was dependent on staff. RN KK said P#1 recently had a cough, and there were concerns he may have contacted COVID. P#1 tested positive for COVID and was placed on an isolation process. RN KK said P#1 did not need extensive COVID medication but was on quarantine for ten days. RN KK said there was a particular day, though she could not recall the date, she came into work and received a shift report. RN KK was informed P#1 would not be kept on a restraint because there was no order, and the facility was avoiding restraint. RN KK said she went to P#1's room around midday to give P#1 his medication and saw P#1 was restrained to the bed. RN KK said she released P#1 and asked who placed the restraint. RN KK said she was told that PCT FF put the restraint on P#1 because PCT FF was trying to clean P#1. RN KK said she educated P#1 and told PCT FF that P#1 could not be restrained without a physician's order. RN KK said throughout the rest of the day, P#1 was not restrained. RN KK stated she went to P#1's room to do a shift report with RN JJ at shift change and found P#1 was in restraint. RN KK stated she asked RN JJ who put the restraint on P#1. RN KK said she was unsure who placed P#1 on restraint but informed RN JJ that P#1 had no order to be restrained.

A review of the facility's policy titled "Patient Restraint/Seclusion Policy," last reviewed 1/21, revealed that the policy's purpose was to protect the dignity and safety of inpatient, outpatient, staff, and visitors through a safe restraint process. Restraint or seclusion use would be limited to clinically justified situations, and the least restrictive restraint would be used to reduce and ultimately eliminate the use of restraints or seclusions.

The following process would be observed:

1. The Registered Nurse (RN) would perform an assessment for risk for restraint or seclusion when a patient exhibited behavior that may place the patient at risk for restraint or seclusion.
2. An order for restraint or seclusion must be obtained from a physician or other licensed practitioner who was acting within their state's Scope of Practice, authorized by state law as having authority for ordering restraints, and was responsible for the care of the patient prior to the application of restraint or seclusion.

A review of the facility's policy titled "Patient Right and Responsibility," last reviewed 2/15, revealed that patients had the right to receive individualized care that fostered the patient's comfort and dignity and would be delivered in a setting that is free from abuse, discrimination, and harassment.


The facility failed to ensure that their policies and procedures were followed as evidenced by failing to protect #1's. The facility failed to ensure that during patient #1's hospitalization their policies and procedures were followed as evidenced by failing to protect his dignity, right to receive care in a safe setting and his safety through a safe restraint process.P#1 was inaccurately restrained at times by only restraining one limb was at the convenience of the staff for passing medications, feeding the patient, clean the patient's room. Additionally, patient #1 was restrained because he tested positive for COVID 19 which resulted in inappropriate Infection Control Precautions for the patient and other patients on the unit.

Based on the review of medical records, an interview with the complainant, interviews with staff, and review of the facility's policies and procedures, it was determined that the facility staff failed to protect two of four sampled Patients (P) (P#1, P#2) rights to be free from restraint without a physician order and clinical justification.

Findings:

A review of Patient (P) #1's medical record revealed that P#1 presented to the facility via Emergency Medical Services (EMS) on 8/5/21 at 7:02 p.m. after he was found staggering down major roads and highways, endangering himself and others. P#1 had multiple hospital visits related to wandering and a history of dementia (loss of memory, language, problem-solving, and other thinking abilities that are severe enough to interfere with daily life). P#1 was found to be impulsive at the facility's ED, attempting to elope multiple times. P#1 was admitted to the facility for dementia evaluation and to ensure safe disposition. Social services and psychiatric consultations were ordered.

A Psychiatric Consultation Note, dated 8/9/21, revealed that P#1 was in an advanced stage of dementia. P #1 did not engage in any conversation with staff and was somewhat agitated. P#1 was placed on Namenda (medication for treating dementia) and Seroquel (antipsychotic used to treat mania, mood disorders, and depression). P#1 was noted to be awaiting long-term placement.

A review of the facility's Patient Order List revealed the following.

A restraints order was active on 10/14/21 at 1:35 p.m. The order expired on 10/15/21 at 1:34 p.m.

A review of the Clinical Documentation Record failed to reveal that P#1 was reassessed at least every two hours.

A restraints order was active on 1/9/22 at 10:03 a.m. The order expired on 1/9/22 at 2:02 p.m.
A review of the facility's restraint documentation revealed that a soft non-violent, all extremities restraint was initiated at 10:14 a.m. Further review revealed that at 7:49 p.m., P#1 was in a soft all extremities restraint.

A review of a Nurse's Note dated 1/9/22 at 9:15 p.m. revealed that RN JJ documented P#1 was in a 4-point restraint during bedside hand-off at 7:50 p.m. Further review of the medical record failed to reveal a renewal restraint order by the provider on 1/9/22 from 2:02 p.m. through 7:50 p.m.

A continued review of the facility's restraint documentation revealed that P#1 was on a soft bilateral upper extremity restraint from 2/10/22 at 9:00 a.m. to 7:30 p.m. RN JJ documented in the nurse notes that P#1's bilateral wrist was angry red. Additionally, RN JJ noted a deep indentation around P#1's wrist.

A review of the facility's clinical documentation record, dated 2/15/22, revealed that at 3:45 p.m., the occupational therapist noted that upon entry to P#1's room, P#1 had a soft restraint on his right wrist and was lying on his right side in the bed. The therapist noted that P#1's pants and bed were wet. The therapist documented that RN KK entered P#1's room to give P#1 his medicine. RN KK said P#1 did not require soft restraint donned on him on this day.

On 2/15 at 7:30 p.m. RN JJ documented in the Nurse Note that P#1 was in bed with his left arm in soft wrist restraint secured to the bed frame, and no physician order was noted. RN JJ documented that RN KK said P#1 would come out of his room at times, especially when medication pass was in progress, so restraint was used temporarily. RN JJ documented that P#1's wrist was reddened with indented skin. RN JJ documented removing restraint. A review of the physician order failed to reveal a restraint order on 2/15/22 for P#1.

A review of Patient (P) #2 medical record revealed that P#2 was admitted to the facility on 1/19/22. P#2 had an altered mental status and a medical history of diabetes (high blood sugar) and hypertension (high blood pressure).

A review of the patient order list included the following:

A restraints order was active on 1/19/22 at 10:06 p.m. The order expired on 1/20/22 at 10:06 p.m.

A restraint order was active on 1/21/22 at 12:25 a.m. The order expired on 1/22/22 at 12:25 a.m.
Detailed review P#2's record failed to reveal a restraint order for 2 hours between 1/20/22 at 10:06 p.m. to 1/21/22 at 12:25 a.m.

An interview was conducted with Registered Nurse (RN) EE on 3/2/22 at 10:28 a.m. RN EE said he had been working at the facility for eight months. RN EE said he recalled P#1 because he had dementia, was non-verbal, dependent on others, and wandered a lot. RN EE said P#1 was recently restrained for infection control because P#1 had COVID. RN EE said the morning of 1/9/22, he went to P#1's room to give him some medication and saw that P#1 had picked up a food tray belonging to another patient. RN EE said P#1 was putting the food in his mouth and seemed to be choking. RN EE said he performed the Heimlich maneuver (first-aid procedure for dislodging an obstruction from a person's windpipe). RN EE explained that he checked P#1's vital signs and realized his oxygen saturation was low. RN EE said he called the Rapid Response Team, suctioned P#1 to get the food out of his mouth and placed a nasal cannula to keep his oxygen saturation up. RN EE said P#1 kept pulling off the nasal cannula. The physician ordered a violent restraint order for P#1. RN EE said he was under the impression that the order was a non-violent restraint for 24 hours, rather than a violent restraint for 4 hours (10:00 a.m. to 2:00 p.m.). RN EE said when he recognized the error, he stopped the restraint at 7:00 p.m. RN EE said P#1 wasn't combative; therefore, he thought it was a non-violent restraint that was ordered. RN EE said he notified the Unit Director once he realized the error. RN EE said he was unaware of any other incidents when P#1 was on restraint without a physician's order. RN EE said he did not provide care for P#1 when P#1 had COVID. RN EE stated he was not aware that P#1 was restrained during this time. RN EE said nurses were supposed to reassess the need for restraints and notify a doctor if they deemed it safe to discontinue the restraints.

An interview was conducted with Unit Director (UD) CC on 3/2/22 at 10:45 a.m. UD CC explained that P#1 had been on the unit for seven months. P#1 had dementia with no family, and the case manager had been working hard to get him placed. UD CC stated they located a relative of P#1s, but the relative also had dementia and needed supervision. UD CC said the facility had been working hard to obtain guardianship and funding for P#1. UD CC stated she was aware of two incidents in which P#1 was restrained. UD CC said that on 1/9/22 at 8:07 p.m., she received a text message from RN EE that P#1 was placed on a violent soft wrist restraint by the physician because P#1 was trying to remove his nasal cannula. However, RN EE thought it was a non-violent restraint, so it was not discontinued after four hours. UD CC said once the nurses were aware of the wrong order, they took P#1 of the restraint. UD CC said RN EE notified her. UD CC stated she provided some education to staff. UD CC said the second incident took place on 2/9/22. P#1 was diagnosed with COVID the day earlier, and during the multidisciplinary rounds, they discussed what to do with the safety of staff and other patients. UD CC said they decided to move P#1 to a negative pressure room and tried putting an N99 mask (face mask that filters airborne particles) on him, but he kept taking off the mask. UD CC said the physician ordered a restraint to keep him from leaving his room. UD CC stated that staff would request an order during the day and discontinue it at night because he was more cooperative. UD CC said the nurses would reassess P#1 every two hours and release his arm for a range of motion. UD CC stated an incident was brought to her attention on 2/22/22. P#1 was found with restraint on his hand. UD CC said that during the bedside shift report, RN JJ noticed a single soft wrist restraint on P#1 and asked RN KK why P#1 was restrained without a physician order. RN KK said PCT FF must have placed P#1 in restraint because he was having difficulty keeping P#1 in his room. PCT FF told RN KK that because P#1 was incontinent when PCT FF tried to clean or feed P#1, and he would not sit still, PCT FF would place a restraint on P#1to feed him and then remove it afterward. UD CC said RN KK educated PCT FF and removed the restraint. UD CC stated her expectation was that staff would notify her or the manager in real-time about such an incident. But, in real-time, staff did not inform her or the manager to address the situation. UD CC said she was unaware of any other time when a patient was restrained without a physician's order. UD CC said the staff had been treating P#1 as a family, and there are several occasions they will buy him candy.

An interview was conducted with Registered Nurse (RN) JJ on 3/7/22 at 9:31 a.m. RN JJ stated she recalled P#1. RN JJ said P#1 was admitted to the facility in August and had deteriorated since his stay at the facility. RN JJ said P#1 could talk, toilet, and feed himself when he was admitted to the facility, but he no longer could do any of those things. RN JJ said she did not believe that P#1's history of dementia caused his deterioration, but rather because the facility would constantly tell P#1 to stay in his room and socially isolate himself. RN JJ said the facility had constantly sedated P#1 by putting him on antipsychotics (Depakote three times a day, Prozac, Ativan, Benadryl, and melatonin). RN JJ said these medications did not help P#1, only kept him sedated. In addition, RN JJ said the facility did not feed P#1 enough, and because P#1 had been homeless, he was not used to getting food regularly. RN JJ stated that she arrived at the facility on 1/9/22 to start her night shift. RN JJ explained that she went to P#1's room at 7:50 p.m. and found that P#1's arms and legs had been restrained (4- point). RN JJ asked RN EE why P#1 was placed in a four-point restraint without a sitter. RN EE said P#1 had gotten into someone's else food and almost choked on some chicken, so the doctor was notified, and P#1 was restrained. RN JJ said she immediately took the restraint off and told RN EE that he should have known that the restraint order was only for four hours. RN JJ said when UD CC was notified about the incident, rather than acknowledging the error, they tried to change the documentation and wrote the wrong time. RN JJ said it was unfair for P#1 to be punished because he was hungry and trying to eat hastily. RN JJ stated that on 2/9/22, P#1 was put in a four-point restraint due to P#1 having COVID. RN JJ said when she began her shift, she removed the restraint, fed, and changed P#1's diaper. RN JJ said if P#1was wet or hungry, he wandered, but he was a happy camper if he was dry and fed. RN JJ said P#1 did not come out of his room throughout her shift. RN JJ said P#1's legs and arms were restrained, and he had no sitter with him. RN JJ said when she asked UD CC if they could get P#1 a sitter because a sitter was the least restrictive measure, UD CC said the facility did not have enough staffing for a sitter. In addition, RN JJ said she observed the facility getting a sitter for a different patient that made a suicide threat jokingly. Still, the facility would not get a sitter for P#1 because he was nonverbal and had no funding. RN JJ said on 2/10/22 when she came to work, she found that P#1 had both wrists tied, and they were red with indentations. RN JJ said P#1 was restraint every shift during the day until 2/14/22, and every time she came in for her shift at night, she would remove the restraint. RN JJ said that when she told UD CC that P#1's wrist was always red and indented from the restraint, UD CC would tell her that P#1 was pulling on the restraint; however, she never saw P#1 pull the restraint. RN JJ said on 2/15/22, when she came to work, she went to P#1's room to feed him around 7:30 p.m. and observed P#1's left arm was restrained. RN JJ said P#1 looked so depressed. RN JJ said she removed the restraint and asked RN LL why P#1 was restrained. RN JJ explained that RN LL said she restrained P#1 because she had to pass medications to other patients and finish her shift without having to watch P#1. RN JJ said the facility started short-staffing the unit by sending some staff to the emergency department. RN JJ said she knew the facility could hire a sitter for P#1, but because he had no money, they probably did not want to get him a sitter. RN JJ said she believed the facility would retaliate against her because she was vocal and concerned that P#1 was illegally restrained. RN JJ said she would have done the same to any other patient. RN JJ said she had to speak up when she observed something wrong and be the voice for her patients. RN JJ said she had requested from the facility to be P#1's guardian.

An interview was conducted with Patient Care Technician (PCT) FF on 3/3/22 at 10:24 a.m. PCT FF said P#1 had been at the facility since September. PCT FF said P#1 was previously considered a 1013 patient (involuntary treatment). PCT FF said P#1 could feed himself, lay in his bed, and walk around, but he progressively got worse, and staff had to start feeding him. PCT FF said it had gotten to the point that staff had to do everything for P#1. A few weeks ago, PCT FF said P#1 was on contact precautions; however, he was walking around the unit without a mask on, so the provider ordered that P#1 be restrained. PCT FF said each time the physician ordered P#1 to be restrained, RN JJ would discontinue the order, so the provider got frustrated and would not put the order in again. PCT FF said P#1 had anxiety and would not sit still when PCT FF tried to feed him, so he would put a restraint on P#1 for about 15 minutes to feed him. PCT FF said he did that about two to three times when he cared for P#1 and also after the restraint order had been discontinued. PCT FF said he was aware, per the facility policies, that only the nurses were allowed to restrain patients. PCT FF said he had mandatory annual training on restraint.

An interview was conducted with RN KK on 3/3/22 at 2:07 p.m. RN KK stated she recalled P#1 because P#1 had dementia with behavioral concerns and wandered around the hallway. RN LL stated the facility tried to keep him safe from wandering off by putting a name tag and room number on P#1. RN KK said P#1 was incontinent, and his total care was dependent on staff. RN KK said P#1 recently had a cough, and there were concerns he may have contacted COVID. P#1 tested positive for COVID and was placed on an isolation process. RN KK said P#1 did not need extensive COVID medication but was on quarantine for ten days. RN KK said there was a particular day, though she could not recall the date, she came into work and received a shift report. RN KK was informed P#1 would not be kept on a restraint because there was no order, and the facility was avoiding restraint. RN KK said she went to P#1's room around midday to give P#1 his medication and saw P#1 was restrained to the bed. RN KK said she released P#1 and asked who placed the restraint. RN KK said she was told that PCT FF put the restraint on P#1 because PCT FF was trying to clean P#1. RN KK said she educated P#1 and told PCT FF that P#1 could not be restrained without a physician's order. RN KK said throughout the rest of the day, P#1 was not restrained. RN KK stated she went to P#1's room to do a shift report with RN JJ at shift change and found P#1 was in restraint. RN KK stated she asked RN JJ who put the restraint on P#1. RN KK said she was unsure who placed P#1 on restraint but informed RN JJ that P#1 had no order to be restrained.

A review of the facility's policy titled "Patient Restraint/Seclusion Policy," last reviewed 1/21, revealed that the policy's purpose was to protect the dignity and safety of inpatient, outpatient, staff, and visitors through a safe restraint process. Restraint or seclusion use would be limited to clinically justified situations, and the least restrictive restraint would be used to reduce and ultimately eliminate the use of restraints or seclusions.

The following process would be observed:

1. The Registered Nurse (RN) would perform an assessment for risk for restraint or seclusion when a patient exhibited behavior that may place the patient at risk for restraint or seclusion.
2. An order for restraint or seclusion must be obtained from a physician or other licensed practitioner who was acting within their state's Scope of Practice, authorized by state law as having authority for ordering restraints, and was responsible for the care of the patient prior to the application of restraint or seclusion.

A review of the facility's policy titled "Patient Right and Responsibility," last reviewed 2/15, revealed that patients had the right to receive individualized care that fostered the patient's comfort and dignity and would be delivered in a setting that is free from abuse, discrimination, and harassment.


Based on the review of medical records, an interview with the complainant, interviews with staff, and review of the facility's policies and procedures, it was determined that the facility staff failed to protect two of four sampled Patients (P) (P#1, P#2) from abuse and violated their patients ' rights by being restrained without a physician's order. Additionally, the facility failed to monitor and reassess one of three sampled patients (P#3) in restraints every two hours.

Findings:

A review of Patient (P) #1's medical record revealed that P#1 presented to the facility via Emergency Medical Services (EMS) on 8/5/21 at 7:02 p.m. after he was found staggering down major roads and highways, endangering himself and others. P#1 had multiple hospital visits related to wandering and a history of dementia (loss of memory, language, problem-solving, and other thinking abilities that are severe enough to interfere with daily life). P#1 was found to be impulsive at the facility's ED, attempting to elope multiple times. P#1 was admitted to the facility for dementia evaluation and to ensure safe disposition. Social services and psychiatric consultations were ordered.

A Psychiatric Consultation Note, dated 8/9/21, revealed that P#1 was in an advanced stage of dementia. P #1 did not engage in any conversation with staff and was somewhat agitated. P#1 was placed on Namenda (medication for treating dementia) and Seroquel (antipsychotic used to treat mania, mood disorders, and depression). P#1 was noted to be awaiting long-term placement.

A review of the facility's Patient Order List revealed the following.

A restraints order was active on 10/14/21 at 1:35 p.m. The order expired on 10/15/21 at 1:34 p.m.
A review of the Clinical Documentation Record failed to reveal that P#1 was reassessed at least every two hours.

A restraints order was active on 1/9/22 at 10:03 a.m. The order expired on 1/9/22 at 2:02 p.m.
A review of the facility's restraint documentation revealed that a soft non-violent, all extremities restraint was initiated at 10:14 a.m. Further review revealed that at 7:49 p.m., P#1 was in a soft all extremities restraint.

A review of a Nurse's Note dated 1/9/22 at 9:15 p.m. revealed that RN JJ documented P#1 was in a 4-point restraint during bedside hand-off at 7:50 p.m. Further review of the medical record failed to reveal a renewal restraint order by the provider from 2:02 p.m. through 7:50 p.m.

A restraints order was active on 2/9/22 at 12:27 p.m. The order expired on 2/10/22 at 12:27 p.m.
A review of the facility's restraint documentation revealed that a soft non-violent, all extremities restraint was initiated at 11:00 a.m. At 2:30 p.m., the soft, all extremities restraint was discontinued, and bilateral upper extremities (both hands) were initiated. Bilateral upper extremities restraint was discontinued at 8:01 p.m.
RN JJ documented on the Nurse Note that P#1 was compliant with staying in his room, P#1 was in bed with eyes closed.

A restraint order was active on 2/10/22 at 12:27 p.m. The order expired on 2/11/22 at 1:44 p.m.
A review of P#1's medical record failed to reveal a restraint order for the 17 minutes between 12:27 p.m. and 1:44 p.m. on 2/11/22.

A continued review of the facility's restraint documentation revealed that P#1 was on a soft bilateral upper extremity restraint from 2/10/22 at 9:00 a.m. to 7:30 p.m. RN JJ documented in the nurse notes that P#1's bilateral wrist was angry red. Additionally, RN JJ noted a deep indentation around P#1's wrist.

A review of the facility's clinical documentation record, dated 2/15/22, revealed that at 3:45 p.m., the occupational therapist noted that upon entry to P#1's room, P#1 had a soft restraint on his right wrist and was lying on his right side in the bed. The therapist noted that P#1's pants and bed were wet. The therapist documented that RN KK entered P#1's room to give P#1 his medicine. RN KK said P#1 did not require soft restraint donned on him on this day.

On 2/15 at 7:30 p.m. RN JJ documented in the Nurse Note that P#1 was in bed with his left arm in soft wrist restraint secured to the bed frame, and no physician order was noted. RN JJ documented that RN KK said P#1 would come out of his room at times, especially when medication pass was in progress, so restraint was used temporarily. RN JJ documented that P#1's wrist was reddened with indented skin. RN JJ documented removing restraint. A review of the physician order failed to reveal a restraint order on 2/15/22 for P#1.

A review of Patient (P) #2 medical record revealed that P#2 was admitted to the facility on 1/19/22. P#2 had an altered mental status and a medical history of diabetes (high blood sugar) and hypertension (high blood pressure).

A review of the patient order list included the following:

A restraints order was active on 1/19/22 at 10:06 p.m. The order expired on 1/20/22 at 10:06 p.m.

A restraint order was active on 1/21/22 at 12:25 a.m. The order expired on 1/22/22 at 12:25 a.m.
Detailed review P#2's record failed to reveal a restraint order for 2 hours between 1/20/22 at 10:06 p.m. to 1/21/22 at 12:25 a.m.

A review of Patient (P) #3 medical record revealed that P#3 was admitted at the facility on 1/30/22 at 10:01 a.m. P#3 had an admission diagnosis of Chronic Obstructive Pulmonary Disease (COPD), cough, and COVID19.

A review of the clinical documentation record failed to reveal two-hour restraint documentation for the following days.
2/24/22 from 6:00 a.m. to 8:00 p.m., 2/25/22 from 6:00 a.m. to 10:00 a.m. 2/25/22 from 4:00 p.m. to 8:00 p.m., 2/26/22 from 6:00 p.m. to 12:15 a.m. 2/26/22 from 2:15 p.m. to 8:00 p.m., 2/27/22 from 4:00 p.m. to 8:00 p.m.

An interview took place in the conference room with the Vice President Quality (VPQ) DD and Patient Safety Officer (PSO) GG. VPQ DD stated that on 2/25/22, the Ethics Compliance Officer (ECO) BB held a meeting with some of the facility's staff because ECO BB was investigating an ethics complaint he received. VPQ DD said from her understanding the complaint was about a patient who had been at the facility for over 200 days, and the facility had been trying to discharge him to a long-term facility. VPQ DD said the complainant was anonymous, but staff submitted the complaint. VPQ DD stated the staff member was concerned that the facility was not the best place for P#1 because P#1's cognitive ability was deteriorating. VPQ DD said the staff didn't like the medication that the provider ordered, and the patient had been in restraint during the course of the stay. VPQ DD said the staff member questioned the necessity. VPQ DD stated the investigation was still ongoing and that ECO BB would be the best to discuss the investigation.

An interview was conducted with the Ethics Compliance Officer (ECO) BB on 3/2/22 at 9:12 a.m. ECO BB explained that he received a complaint about P#1. ECO BB stated that P#1 had been admitted to the facility for a long time. P#1 had dementia and the facility had trouble providing a safe discharge. ECO BB said P#1 needed to go to a skilled nursing facility but had no guardian or funding. ECO BB said P#1's aunt was his only relative, and she could not care for P#1. ECO BB stated the facility had started processing P#1's paperwork to get his guardianship. ECO BB said after receiving the complaint report on 2/23/22, he began investigating and had a meeting on 2/25/22 with the Patient Safety Officer (PSO) GG, Unit Director (Dir) CC, Chief Nursing Officer (CNO) HH, Unit Manager (Mg) II. ECO BB said they reviewed P#1's medical record and found a note written by Registered Nurse (RN) JJ alleging P#1 was restrained without a physician's order. ECO BB stated that RN JJ had been very attached to P#1, and she inquired of the leadership to take on guardianship of P#1. ECO BB said he discussed this with corporate legal, and they said if there were no monetary gain, it would be between RN JJ and the court. ECO BB said he didn't know if RN JJ followed up with being P#1's guardian. ECO BB said while investigating the allegation; it was identified that the Patient Care Technician (PCT) FF had used a single restraint to keep P#1 in the room when he cleaned P#1's room. ECO BB said PCT FF was counseled. ECO BB stated the investigation was still ongoing. Once the investigation was completed, ECO BB would have a final report and present the case to the Governing Board.

An interview was conducted with Registered Nurse (RN) EE on 3/2/22 at 10:28 a.m. RN EE said he had been working at the facility for eight months. RN EE said he recalled P#1 because he had dementia, was non-verbal, dependent on others, and wandered a lot. RN EE said P#1 was recently restrained for infection control because P#1 had COVID. RN EE said the morning of 1/9/22, he went to P#1's room to give him some medication and saw that P#1 had picked up a food tray belonging to another patient. RN EE said P#1 was putting the food in his mouth and seemed to be choking. RN EE said he performed the Heimlich maneuver (first-aid procedure for dislodging an obstruction from a person's windpipe). RN EE explained that he checked P#1's vital signs and realized his oxygen saturation was low. RN EE said he called the Rapid Response Team, suctioned P#1 to get the food out of his mouth and placed a nasal cannula to keep his oxygen saturation up. RN EE said P#1 kept pulling off the nasal cannula. The physician ordered a violent restraint order for P#1. RN EE said he was under the impression that the order was a non-violent restraint for 24 hours, rather than a violent restraint for 4 hours (10:00 a.m. to 2:00 p.m.). RN EE said when he recognized the error, he stopped the restraint at 7:00 p.m. RN EE said P#1 wasn't combative; therefore, he thought it was a non-violent restraint that was ordered. RN EE said he notified the Unit Director once he realized the error. RN EE said he was unaware of any other incidents when P#1 was on restraint without a physician's order. RN EE said he did not provide care for P#1 when P#1 had COVID. RN EE stated he was not aware that P#1 was restrained during this time. RN EE said nurses were supposed to reassess the need for restraints and notify a doctor if they deemed it safe to discontinue the restraints.

An interview was conducted with Unit Director (UD) CC on 3/2/22 at 10:45 a.m. UD CC explained that P#1 had been on the unit for seven months. P#1 had dementia with no family, and the case manager had been working hard to get him placed. UD CC stated they located a relative of P#1s, but the relative also had dementia and needed supervision. UD CC said the facility had been working hard to obtain guardianship and funding for P#1. UD CC stated she was aware of two incidents in which P#1 was restrained. UD CC said that on 1/9/22 at 8:07 p.m., she received a text message from RN EE that P#1 was placed on a violent soft wrist restraint by the physician because P#1 was trying to remove his nasal cannula. However, RN EE thought it was a non-violent restraint, so it was not discontinued after four hours. UD CC said once the nurses were aware of the wrong order, they took P#1 of the restraint. UD CC said RN EE notified her. UD CC stated she provided some education to staff. UD CC said the second incident took place on 2/9/22. P#1 was diagnosed with COVID the day earlier, and during the multidisciplinary rounds, they discussed what to do with the safety of staff and other patients. UD CC said they decided to move P#1 to a negative pressure room and tried putting an N99 mask (face mask that filters airborne particles) on him, but he kept taking off the mask. UD CC said the physician ordered a restraint to keep him from leaving his room. UD CC stated that staff would request an order during the day and discontinue it at night because he was more cooperative. UD CC said the nurses would reassess P#1 every two hours and release his arm for a range of motion. UD CC stated an incident was brought to her attention on 2/22/22. P#1 was found with restraint on his hand. UD CC said that during the bedside shift report, RN JJ noticed a single soft wrist restraint on P#1 and asked RN KK why P#1 was restrained without a physician order. RN KK said PCT FF must have placed P#1 in restraint because he was having difficulty keeping P#1 in his room. PCT FF told RN KK that because P#1 was incontinent when PCT FF tried to clean or feed P#1, and he would not sit still, PCT FF would place a restraint on P#1to feed him and then remove it afterward. UD CC said RN KK educated PCT FF and removed the restraint. UD CC stated her expectation was that staff would notify her or the manager in real-time about such an incident. But, in real-time, staff did not inform her or the manager to address the situation. UD CC said she was unaware of any other time when a patient was restrained without a physician's order. UD CC said the staff had been treating P#1 as a family, and there are several occasions they will buy him candy.

An interview was conducted with Registered Nurse (RN) JJ on 3/7/22 at 9:31 a.m. RN JJ stated she recalled P#1. RN JJ said P#1 was admitted to the facility in August and had deteriorated since his stay at the facility. RN JJ said P#1 could talk, toilet, and feed himself when he was admitted to the facility, but he no longer could do any of those things. RN JJ said she did not believe that P#1's history of dementia caused his deterioration, but rather because the facility would constantly tell P#1 to stay in his room and socially isolate himself. RN JJ said the facility had constantly sedated P#1 by putting him on antipsychotics (Depakote three times a day, Prozac, Ativan, Benadryl, and melatonin). RN JJ said these medications did not help P#1, only kept him sedated. In addition, RN JJ said the facility did not feed P#1 enough, and because P#1 had been homeless, he was not used to getting food regularly. RN JJ stated that she arrived at the facility on 1/9/22 to start her night shift. RN JJ explained that she went to P#1's room at 7:50 p.m. and found that P#1's arms and legs had been restrained (4- point). RN JJ asked RN EE why P#1 was placed in a four-point restraint without a sitter. RN EE said P#1 had gotten into someone's else food and almost choked on some chicken, so the doctor was notified, and P#1 was restrained. RN JJ said she immediately took the restraint off and told RN EE that he should have known that the restraint order was only for four hours. RN JJ said when UD CC was notified about the incident, rather than acknowledging the error, they tried to change the documentation and wrote the wrong time. RN JJ said it was unfair for P#1 to be punished because he was hungry and trying to eat hastily. RN JJ stated that on 2/9/22, P#1 was put in a four-point restraint due to P#1 having COVID. RN JJ said when she began her shift, she removed the restraint, fed, and changed P#1's diaper. RN JJ said if P#1was wet or hungry, he wandered, but he was a happy camper if he was dry and fed. RN JJ said P#1 did not come out of his room throughout her shift. RN JJ said P#1's legs and arms were restrained, and he had no sitter with him. RN JJ said when she asked UD CC if they could get P#1 a sitter because a sitter was the least restrictive measure, UD CC said the facility did not have enough staffing for a sitter. In addition, RN JJ said she observed the facility getting a sitter for a different patient that made a suicide threat jokingly. Still, the facility would not get a sitter for P#1 because he was nonverbal and had no funding. RN JJ said on 2/10/22 when she came to work, she found that P#1 had both wrists tied, and they w

Based on the review of medical records, an interview with the complainant, interviews with staff, and review of the facility's policies and procedures, it was determined that the facility staff failed to protect two of four sampled Patients (P) (P#1, P#2) from restraints without a physician's order for the convenience of care. The facility failed to document the explorations of the least restrictive means of care.

Cross refer to A-0129 as it relates to the facility' s failure to ensure that patients are free from restraints unless clinically justified.

Based on interviews with staff, review of the facility's Ethic Line Case Report, and review of the facility's Clinical Excellence Committee Meetings, it was determined the facility staff failed to actively follow its Quality Assurance and Performance Improvement (QAPI) Plans related to restraint and seclusion.

Findings:

An interview took place in the conference room with the Vice President Quality (VPQ) DD and Patient Safety Officer (PSO) GG. VPQ DD stated that on 2/25/22, the Ethics Compliance Officer (ECO) BB held a meeting with some of the facility's staff because ECO BB was investigating an ethics complaint he received. VPQ DD said from her understanding the complaint was about a patient who had been at the facility for over 200 days, and the facility had been trying to discharge him to a long-term facility. VPQ DD said the complainant was anonymous, but staff submitted the complaint. VPQ DD stated the staff member was concerned that the facility was not the best place for P#1 because P#1's cognitive ability was deteriorating. VPQ DD said the staff didn't like the medication that the provider ordered, and the patient had been in restraint during the course of the stay. VPQ DD said the staff member questioned the necessity. VPQ DD stated the investigation was still ongoing and that ECO BB would be the best to discuss the investigation.

An interview was conducted with the Ethics Compliance Officer (ECO) BB on 3/2/22 at 9:12 a.m. ECO BB explained that he received a complaint about P#1. ECO BB stated that P#1 had been admitted to the facility for a long time. P#1 had dementia and the facility had trouble providing a safe discharge. ECO BB said P#1 needed to go to a skilled nursing facility but had no guardian or funding. ECO BB said P#1's aunt was his only relative, and she could not care for P#1. ECO BB stated the facility had started processing P#1's paperwork to get his guardianship. ECO BB said after receiving the complaint report on 2/23/22, he began investigating and had a meeting on 2/25/22 with the Patient Safety Officer (PSO) GG, Unit Director (Dir) CC, Chief Nursing Officer (CNO) HH, Unit Manager (Mg) II. ECO BB said they reviewed P#1's medical record and found a note written by Registered Nurse (RN) JJ alleging P#1 was restrained without a physician's order. ECO BB stated that RN JJ had been very attached to P#1, and she inquired of the leadership to take on guardianship of P#1. ECO BB said he discussed this with corporate legal, and they said if there were no monetary gain, it would be between RN JJ and the court. ECO BB said he didn't know if RN JJ followed up with being P#1's guardian. ECO BB said while investigating the allegation; it was identified that the Patient Care Technician (PCT) FF had used a single restraint to keep P#1 in the room when he cleaned P#1's room. ECO BB said PCT FF was counseled. ECO BB stated the investigation was still ongoing. Once the investigation was completed, ECO BB would have a final report and present the case to the Governing Board.

A review of the facility's "Ethic Line Case Report" revealed concerns of quality of patient care expressed by the complainant to the facility on behalf of P#1. Further review revealed that the Ethic Compliance Officer (ECO) BB held a meeting with the Patient Safety Officer (PSO) GG, Unit Director (Dir) CC, Chief Nursing Officer (CNO) HH, and Unit Manager (Mg) II to discuss the complaint. A detailed review revealed that the investigation was ongoing.

A review of the Clinical Excellence Committee Meetings dated 8/3/ 2021 to 1/2/22 revealed that the facility was actively tracking the total number of patients in restraints in relation to the census to look for variances in volume. Further review revealed that the facility was actively tracking violent and nonviolent restraints, hours in restraints, clinical justification, violent and nonviolent episodes, and restraints by location. The Clinical Excellence Committee Meeting consisted of VPD DD, unit directors, and quality managers. The outcomes of the report are presented at the medical executive meeting and board meetings