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Based on record reviews and staff interviews, it was determined the hospital failed to ensure the rights and safety of patients during restraints.

Findings include:

The Condition level deficiency is the result of the standard deficiencies found under the Condition of Participation for Patient Rights for the following tags:

Tag A-0154: 1. The facility failed to ensure policies and procedures were followed during the physical restraints of Patients #1, #11, and #15. Patient #1 was physically held with [his] arms behind [his] back sitting in a chair by a Security Officer (SO) and other staff holding down [his] legs. The patient sustained injuries during the restraint. Patient #11 was physically held by a SO so staff could administer chemical restraints. Patient #15 was physically restrained by a SO and staff when the patient became aggressive and tried to leave the ED. The patient was held against a wall by the SO and then slipped and fell to the tile floor during the restraint and hit [his] head and face.

2. The facility failed to ensure #9 was not chemically restrained for staff convenience. The patient was transferred from a medical/surgical unit to the Intensive Care Unit where [he] was sedated for over 24 hours because of an episode of combative behavior.

Tag A-0167: 1. The hospital failed to ensure the type of physical hold restraints techniques were defined and approved for use by hospital policies and procedures, and;

2. The hospital failed to ensure Security Officers (SO) had current training on the safe use and application of all types of restraints. Patient1, #9 #11, and #15 were physically restrained (held). The Officer(s) had no documentation of current training of the use of physical holds of elderly patients.

Tag A-0168: The hospital failed to ensure medical practitioner orders were provided for the use of physical restraints. Patients #1, Patient #4, Patient #11, and Patient #15 were physically restrained by Security Officers with no physician orders.

Tag A-0174: the hospital failed to ensure restraints were discontinued at the earliest time. (Patient #4 and Patient #14).

The cumulative effect of these systemic failures resulted in the hospital's inability to protect and promote the patient rights and safety.

Based on record reviews and staff interviews, it was determined:

1. The facility failed to ensure policies and procedures were followed during the physical restraints of Patients #1, #11, and #15. Patient #1 was physically held with [his] arms behind [his] back sitting in a chair by a Security Officer (SO) and other staff holding down [his] legs. The patient sustained injuries during the restraint. Patient #11 was physically held by a SO so staff could administer chemical restraints. Patient #15 was physically restrained by a SO and staff when the patient became aggressive and tried to leave the ED. The patient was held against a wall by the SO and then slipped and fell to the tile floor during the restraint and hit [his] head and face.

2. The facility failed to ensure #9 was not chemically restrained for staff convenience. The patient was transferred from a medical/surgical unit to the Intensive Care Unit where [he] was sedated for over 24 hours because of an episode of combative behavior.

Findings include:

The hospital's Restraint and Seclusion Policy included: "I. Purpose ...This facility ensures that restraint and seclusion interventions are safely and appropriately used. Because of the associated risks and consequences of use, this facility is continually exploring ways to decrease restraint use through effective preventative strategies or the use of alternatives. Policies and procedures for the use of restraint and seclusion are developed through an interdisciplinary process and approved by medical staff and administration. Staff roles and responsibilities in the use of restraints and seclusion are identified for all appropriate disciplines ... II. Definitions ...Restraint: is any physical or mechanical device, material, medication or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body or head freely. A restraint can be a drug or medication when it is used as a restriction to manage the patient's behavior or restrict the patient's freedom of movement and is NOT a standard treatment or dosage for the patient's condition. The application of force to physically hold a patient is considered a restraint; e.g. therapeutic hold in order to administer a medication against the patient's wishes. A drug or medication when it is used as a restriction to manage the patient's behavior or restrict the patient's freedom of movement and is not a standard treatment or dosage for the patient's condition. Though patients have the right to refuse treatments, under certain circumstances, if serious bodily harm is judged to be imminent (e.g. violent patient) an R.N. after assessment of the patient should institute the use of restraint, which he/she believes will protect the patient and/or others effectively, but alternatives must be considered ...vi. The intervention should not cause or inflict harm to the patient...C. Restraints are not to be used for punishment, coercion, discipline,or retaliation of the patient, or for staff convenience...VI. PROCEDURES ...Our facility ensures staff, who have direct patient care responsibilities including contract or agency personnel, receive training and are competent to minimize the use of restraint and seclusion, and to use them safely when their use is indicated. Our facility assures the staff providing training is qualified as evidenced by education, training, and experience in techniques to address patients' behaviors...Staff is expected to continually assess and monitor the patient to ensure the patient is released from restraint or seclusion at the earliest possible time. A RN with documented restraint and seclusion competency many discontinue restraint or seclusion...When a drug or medication is used as a restriction to manage the patient's behavior or restrict the patient's freedom of movement, monitoring may be more frequent after administration such as every 15 minutes for first 2 hours, depending on the dose and type of drug or medication ordered ...."

The above policy and procedures are specific to staff who have direct patient care responsibilities. There are no provisions in the policy and procedure for security staff to participate in any form of restraint.

Patient #1:

Patient #1, who was over the age of [80] years, was taken to the hospital's Emergency Department on 07/06/2023 after becoming dizzy and falling at home. The ED report revealed the patient had several episodes of dizziness over the past couple of weeks in addition to periods of nausea. The patient's past medical history included pulmonary embolism and [he] took Warfarin (anticoagulant) for that. The patient was described to be alert, oriented, and cooperative with normal mood and affect. A head Computerized Tomography (CT) scan was performed which revealed, "No acute intracranial finding." The patient was noted to be hypertensive while in the ED, and the decision was made to admit the patient for further evaluation of the episodes of dizziness and falls.

The patient arrived to the inpatient unit in the early hours of 07/07/2023. A brain MRI was ordered because of the patient's continuing report of dizziness. The MRI Technologist documented the procedure started at 9:32 p.m. but was canceled at 10:13 p.m. because "Patient refused."

Nursing documentation dated 07/07/2023 at 7:43 p.m. revealed the patient was alert and oriented x 4 with complaints of dizziness and nausea which was resolved with medication. The patient became increasingly agitated, confused and combative with staff while trying to redirect him back to bed. Nursing documentation dated 07/07/2023 at 11 p.m. included:

"Ativan ordered and given before MRI.
MRI brain not able to be completed due to agitation as stated per MRI tech around 2200 patient became combative, becoming very restless.
Charge RN, staff, and this RN were doing best to comfort and redirect patient back to room.
Code grey called.
Patient with nausea-benadryl given for relief
Geodon given due to situation.
Once back into bed-emesis episodes recurrent-suctioned patient as needed and kept patient upright, breathing slowed, new garbled and imprecise speech with communication was noted
patient vitals monitored in meantime before transfer to ICU..."

There was no nursing documentation that detailed the events that occurred during the Code Grey including the actions of the Security Officer and other staff who responded.

Nursing documentation by the ICU nurse after the patient arrived included: "0000 Pt arrived with RN and nursing supervisor. Pt was drowsy and transferred to ICU bed with no apparent issues during transfer to ICU bed. Upon CHG bath assessment, pt has multiple skin tears and bruises/ecchymotic all over bilateral arms and legs...Pt will not answer questions due to drowsiness but does open eyes to voice and follows commands...." The patient's condition deteriorated, and he was noted to have left sided weakness on 07/08/2023. A head MRI revealed, " ...new acute/subacute infarction left cerebral peduncle ..." The patient continued to deteriorate with subsequent MRI's showing "devastating" strokes. Family members made the decision to transfer the patient's care to comfort measures only, and the patient was discharged to an inpatient hospice provider on 07/12/2023 where [he] died.

The Security Officer's (Staff #7) report of the Code Grey on 07/07/2023 for Patient #1 included the following:

On 07/07/2023 at approximately 2225 I ...was called to a Code Grey at [Patient #1's Room number.]. When I arrived I found the patient being aggressively resistant with medical staff as they urged [him] to return to [his] bed. As [he] was placed in a chair [he] began to swat randomly at staff. I placed the patient in a PRT [Primary Restraint Technique] as [his] wrist IV negated the option of wrist holds. [He] continued to be aggressive with staff as orders for medication were placed. [He] was held in this sitting position for over 15 min which resulted in my being in a bent twisted position holding [him] in the restraint. After medication was administered [he] was transferred back to [his] bed with no further assistance from security ...."

Patient #9:

Patient #9 who was over the age of [75] years taken to the hospital on 06/23/2023 after a syncopal episode following chemotherapy infusion. The History and Physical report revealed the patient was alert, oriented, cooperative, and had normal mood, affect, and cognition. A physician progress note dated 6/23/2023 at 1:28 p.m. included: "...unfortunately overnight [he] became quite agitated, aggressive, attempting to hit staff and leave the bed. Requiring IV benzodiazepine, four point restraints. This morning at roughly 0830 code gray was called again for similar situation. (Family member) spoke to [his] prior severe reaction/psychosis to benzodiazepines at prior surgery...." Documentation in the Discharge Summary dated 06/24/2023 included: "...Initial plan was to monitor overnight to ensure there is no infectious component of [his] adverse reaction and chemotherapy session. Unfortunately [he] sundown [sic] quite significantly and became aggressive, violent, requiring IV benzodiazepines. Unbeknownst to the medical staff, the patient has had a severe reaction to benzodiazepines in the past, which [his wife] described as psychotic behavior. Unfortunately after this treatment, [he] did become increasingly confused and agitated and psychotic. Due to the concerns for [his] safety and that of the staff, [he] was transitioned to the ICU where [he] received Precedex therapy, on 6/24 with the assistance of [his] family, [he] was able to be weaned off these medications, was calm and collected although still confused...." A review of the physician orders revealed a continuous intravenous infusion of Precedex was ordered on 06/23/2023 at 1:51 p.m., and it was discontinued on 06/24/2023 at 5:02 p.m., a period of approximately 25 hours.

Pfizer Pharmaceutical is the the manufacture of Precedex. Information on Pfizer's website related to Precedex includes: "...1 INDICATIONS AND USAGE 1.1 Intensive Care Unit Sedation PRECEDEX is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. PRECEDEX should be administered by continuous infusion not to exceed 24 hours...."

An interview was conducted with the Chief Medical Officer (Staff #4) and with the Director of Pharmacy (Staff #5). Patient #5's clinical record was reviewed during that time specific to the physician having the patient transferred to the ICU and ordering Precedex to sedate the patient for over 24 hours to control [his] behavior. Staff #4 and Staff #5 reported not being aware of Precedex being ordered and administered to control a patient's behavior.

Patient #11:

Patient #11 who was over the age of [75] year admitted to the hospital on 06/16/2023. Nursing documentation on 06/25/2023 at 4:48 a.m. included: "At around 2230 patient became combative and verbally aggressive. Hospitalist was aware and orders were received. Patient then became more combative. patient bit one RNN [sic] twice and kicked another Rn on the head upon assisting with patient care. Code gray was called. Dr. (name) came at bedside more orders were received...." The Security report revealed a Security responded and , "...assisted medical staff restrain patient while medical staff administered meds...."

Patient #15:

Patient #15 was a minor patient under the age of 18. The patient was taken to the ED by the responsible family member on 06/19/2023 at 8:13 p.m. The patient was evaluated by an ED physician who documented the patient had a history of depression, aggressive behavior and past inpatient psychiatric admission. The patient was still in the lobby when the patient became violent with staff and striking staff members. The physician documented: "During the patient actively resisting security's efforts to de-escalate the situation, the patient feel and hit [his] head, [his] face on the floor of the emergency department. The physician's physical assessment of the patient after the patient was restrained included: "...Patient has swelling abrasions overlying the left aspect of the forehead as well as the bridge of the nose There is also abrasions and scratch marks on the upper extremities as well as on the knuckles of the bilateral upper extremities...The patient required medical sedation as [he] was trying to get out of the exam bed and was not participating with any of the medical interventions for medical clearance...[He] was given IM Haldol, lorazepam and Benadryl...." The patient was discharged Against Medical Advice to the care of the responsible family member on 06/20/2023 at 1:36 a.m.

The SO's documentation of the incident in an event report included the following: "...On 06/19/2023 at approximately 2102 hours I, (Staff #7) was dispatched to a call of an assault on staff by a patient...When I arrived I found the patient posturing aggressively towards ED staff. When the ED staff attempted to walk the patient back to the behavioral unit the patient threw [himself] on the floor and refused to move. When staff attempted to assist the patient with standing up the patient made a threatening motion with [his] fist. Once instructed to remain calm [he] was assisted to [his] feet by myself and ED staff (name). The patient broke free and attempted to flee again. I compelled the patient's movement against the wall to prevent any additional violence from the patient and instructed the patient to calm down. Once [he] relaxed (staff name) and I continued with our attempt to escort the patient to the Behavioral Unit. It was at this time the patient made another attempt to break away and run. The patient wearing no shoes only socks slipped on the tile floor. As he slipped and fell [his] right foot kicked my left foot out from underneath me causing myself and (staff name), still maintaining our physical hold, to also fall to the floor with the patient. Once on the floor the patient continued to resists [sic] for a few moments but with the combined hold from me and (staff name) the patient conceded to calm down. A stretcher was brought over and the patient was brought up on the bed and placed in 4-point restraints.

Staff #2 and Staff #3 reported during interviews that the hospital's restraint policies did not include Security Officers physically holding and/or restraining patients in any other manner. They acknowledged the restraint policies did not identify the type(s) of physical holds determined to be appropriate and approved by the governing body. They acknowledged one or more of the Security Officers did not have current training on de-escalation and restraints.

Based on record reviews and staff interviews, it was determined:

1. The hospital failed to ensure the type of physical hold restraints techniques were defined and approved for use by hospital policies and procedures, and;

2. The hospital failed to ensure Security Officers (SO) had current training on the safe use and application of restraints. Patients #1, #11, and #15 were physically restrained (held) by Security Officers. The Officer(s) had no documentation of current training on the use of physical holds of patients.

Findings include:

1. The hospital's Restraint and Seclusion Policy did not include the type(s) of physical hold techniques approved for use on patients.

Refer to Tag A-0154 for the following patients:

Patient #1 became confused and tried to leave [his] room after returning from an attempted MRI on 07/07/2023. The patient became combative during staff attempts to return to [his] room. A Code Grey was called, and a Security Officer (Staff #7) responded to the unit at approximately 10:25 p.m. Staff #7 physically restrained the patient by holding the patient's arm behind the patient's back who was being held down by staff in a chair. Documentation in Staff #7's report revealed the patient's hold lasted for a period of fifteen to twenty minutes.

The Security Officer's (Staff #7) report of the Code Grey on 07/07/2023 for Patient #1 included the following:

On 07/07/2023 at approximately 2225 I ...was called to a Code Grey at [Patient #1's Room number.]. When I arrived I found the patient being aggressively resistant with medical staff as they urged him to return to his bed. As he was placed in a chair he began to swat randomly at staff. I placed the patient in a PRT (Primary Restraint Technique) as [his] wrist IV negated the option of wrist holds. [He] continued to be aggressive with staff as orders for medication were placed. [He] was held in this sitting position for over 15 min which resulted in my being in a bent twisted position holding him in the restraint. After medication was administered [he] was transferred back to [his] bed with no further assistance from security ...."

An interview was conducted with Staff #7 on 08/21/2023 3:15 p.m. interview with Staff #7. Staff #7 reported that part of [his] role is to restrain patients including holding patients to control their behavior. [He] was asked if [he] takes direction from a Registered Nurse in those situations, and [he] responded that [he] does so on [his] own without direction from staff.

An interview was conducted with the Director of Security (Staff #6) on 08/21/2023. Staff #7's personnel record was reviewed during the interview. There was no documentation in the Position Description for Security Officers for the use of restraints on patients. The personnel record revealed a Handle with Care De-escalation Certificate that expired on 10/31/2022. Staff #6 reported the Security Officers were taught "some [physical] holds" as well as de-escalation techniques. Staff #6 stated [he] was aware of the expired certificate and was in the process of getting the Security Officers scheduled to update the training. The Instructor's Manual for Handle With Care training included training on multiple physical hold techniques for various situations, many of which were not appropriate for patients in a healthcare setting. Staff #6 was asked which of the numerous holds demonstrated in the manual were approved for use in the hospital setting, and [he] did not know.

Patient #11:

Patient #11 who was over the age of [75] year admitted to the hospital on 06/16/2023. Nursing documentation on 06/25/2023 at 4:48 a.m. included: "At around 2230 patient became combative and verbally aggressive. Hospitalist was aware and orders were received. Patient then became more combative. patient bit one RNN (sic) twice and kicked another Rn on the head upon assisting with patient care. Code gray was called. Dr. (name) came at bedside more orders were received...." The Security report revealed a Security responded and , "...assisted medical staff restrain patient while medical staff administered meds...." There no documentation that clarified what type of hold was used or the duration of the hold.

Patient #15:

Patient #15:

Patient #15 was a minor patient under the age of 18. The patient was taken to the ED by the responsible family member on 06/19/2023 at 8:13 p.m. The patient was evaluated by an ED physician who documented the patient had a history of depression, aggressive behavior and past inpatient psychiatric admission. The patient was still in the lobby when the patient became violent with staff and striking staff members.

The physician documented: "During the patient actively resisting security's efforts to de-escalate the situation, the patient feel and hit [his] head, [his] face on the floor of the emergency department. The physician's physical assessment of the patient after the patient was restrained included: "...Patient has swelling abrasions overlying the left aspect of the forehead as well as the bridge of the nose There is also abrasions and scratch marks on the upper extremities as well as on the knuckles of the bilateral upper extremities..." The SO's document of the incident revealed the patient was held against a wall at one point and then was held and "escorted" back to the ED when [he] attempted to break away and run, and slipped and fell.

Staff #2 and Staff #3 reported during interviews that the hospital's restraint policies did not include Security Officers physically holding and/or restraining patients in any other manner. They acknowledged the restraint policies did not identify the type(s) of physical holds determined to be appropriate and approved by the governing body.

Staff #2 and Staff #3 agreed there was no documentation that defined they type(s) of physical holds could be utilized for patients.

Based on record review and staff interview, it was determined the hospital failed to ensure medical practitioner orders were provided for the use of physical restraints. Patients #1, Patient #4, Patient #11, and Patient #15 were physically restrained by Security Officers (SO) with no physician orders.

Findings include:

The hospital's Restraint and Seclusion Policy included: "...ORDERS FOR RESTRAINT ...i) The physician or Licensed Independent Practitioners {LIP} responsible for the care of the patient is authorized to order a restraint. Physicians and LIPs authorized to order restraint and seclusion must have a working knowledge of hospital policy regarding restraint and seclusion. Orders should: a) Be for each use of the restraints and related to a specific episode of the patient's behavior and not for an unspecified future time or episode ...ii) In an emergency application situation, a RN who has documented Restraint and Seclusion competency may initiate the application of restraint or seclusion prior to obtaining an order from a LIP. In this event the order must be obtained either during the emergency application of the restraint or seclusion or immediately (within a few minutes) after the restraint or seclusion has been applied...."

Patient #1:

Patient #1 became confused and tried to leave [his] room after returning from an attempted MRI on 07/07/2023. The patient became combative during staff attempts to return to [his] room. A Code Grey was called, and a Security Officer (Staff #7) responded to the unit at approximately 10:25 p.m. Staff #7 physically restrained the patient by holding the patient's arm behind the patient's back who was being held down by staff in a chair. Documentation in Staff #7's report revealed the patient's hold lasted for a period of fifteen to twenty minutes. There was no documentation in the clinical record that a provider's order was obtained for the physical hold by Staff #7.

Staff #2 and Staff #3 agreed there was no medical provider order for the physical hold.

Patient #4:

A physician's progress note dated 06/18/2023 included: "...in restraints now, discussed with RN. If he cooperates can try to remove later today...."

There was no medical provider's order for restraints in the clinical record. Staff #1 reported that Health Information Management staff were also unable to locate a medical provider's order for restraints referenced by the physician on 06/18/2023.

Patient #11:

Patient #11 was documented to be combative and verbally aggressive on 06/25/2023. A Code Grey was called, and the Security report revealed the SO who responded assisted in restraining the patient so staff could administer medications. There was no physician order for the SO's physical hold of the patient.

Patient #15:

Patient #15 was documented to be "violent" with staff in the Emergency Department on 06/19/2023. The patient was held against a wall by a SO and then physically held by a SO and staff member. The patient slipped and fell hitting [his] head and face on the tile floor. There were no physician orders for the physical holds by the SO and other staff involved.

Based on record reviews and staff interview, it was determined for 2 of 7 patients who were physically restrained the hospital failed to ensure restraints were discontinued at the earliest time. (Patient #4 and Patient #15).

Findings include:

The hospital's Restraint and Seclusion policy and procedure included: "...Staff is expected to continually assess and monitor the patient to ensure the patient is released from restraint or seclusion at the earliest possible time...."

Patient #4 had bilateral soft wrist restraints applied on 06/20/2023 at approximately 7:30 p.m. There was no documentation that the patient's restraints were monitored between midnight on 06/21/2023 unti 8 a.m., a period of 8 hours. Restraint documentation dated 06/21/2023 described the patient's behavior at 10 a.m., 12 p.m., and 2 p.m. as "calm." The restraints were not discontinued until 3 p.m. on 06/21/2023, 5 hours later.

Patient #15 had four-point restraints applied in the Emergency Department on 07/24/2023 at 10 p.m. for violent danger to self and other behaviors. Nursing assessments of the patient revealed the patient was sleeping at 11 p.m., midnight; 1 a.m., and 1:58 a.m. on 07/25/2023 The restraints were not discontinued until 1:58 p.m.

The medical record was reviewed with Staff #1 who acknowledged the patient was documented to be calm for a period of five hours before the restraints were discontinued.

Based on record review, interviews, it was determined the hospital failed to have a quality assessment and performance improvement program that reflected the complexity of the hospital's organization and services involving all hospital departments as evidenced by:

A-0273 (Data Collection and Analysis): The hospital failed to monitor the effectiveness of the process of restraint and seclusion as evidenced by the quality program tracking only numbers of episodes of mechanical restraints and failure to include chemical restraints, and physical holds including physical holds by Security Officers. Patients #1, #9, #11, and #14 received chemical and/or were physically held (restrained).

A-0286 (Patient Safety): The hospital: 1. Failed to perform a complete analysis of Patient #1 being physically held by a Security Officer (SO). A Security Officer held Patient #1's arms behind [his] back while sitting in a chair for approximately 15 minutes. The hospital's investigation did not identify there was no physician's order for the physical hold; the Security Officer's restraint training certificate had expired; and the hospital's restraint policies did not allow for Security Officers to be involved in restraints; and 2. Failed to ensure an event report was generated and investigated for Patient #2 who was an elderly, cognitively impaired person who eloped from the Emergency Department.

A-0315 (Adequate Resources): The governing body failed to ensure adequate resources were allocated to sustain the hospital's Quality Assessment and Performance Improvement Plan to collect and analyze data and implement processes to increase desired outcomes for the provision of quality and safe care to patients.

The cumulative effect of these systemic deficient practices resulted in the facility's failure to meet the requirement for Condition of Participation for Quality Assessment and Performance Improvement to ensure the provision of quality care in a safe environment.

Based on review of clinical records, policies and procedures and staff interviews, it was determined the hospital failed to monitor the effectiveness of the process of restraint and seclusion as evidenced by the quality program tracking only numbers of episodes of mechanical restraints and failure to include chemical restraints, and physical holds including physical holds by Security Officers. Patients #1, #9, #11, and #14 received chemical and/or were physically held (restrained).

Findings include:

The hospital's Quality Assessment and Performance Improvement Plan (QAPI) included: "...Performance Improvement is the ongoing analysis and adoption of processes to increase the probability of achieving desired outcomes to meet the needs of patients and other customers. Northwest Medical Center's plan for performance includes a systematic approach to planning, designing, measuring, assessing and continuously improving processes and outcomes to ensure safe patient care... Northwest Medical Center recognizes opportunities for improvement and implements performance improvement plans using the following performance improvement methodologies/tools for ongoing evaluation of the success of sustainability of interventions...Plan-Do-Study-Act (PDSA) Cycle:...Plan - Plan the test or observation, including a plan for collecting data...Do - Run the test or complete the observation on a small scale...Study - Analyze the results and compare them to your predictions...Act - Based on what was learned from the test or observation, plans the next step...."

The hospital's Restraint and Seclusion Policy included:

II. Definitions ...Restraint: is any physical or mechanical device, material, medication or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body or head freely. A restraint can be a drug or medication when it is used as a restriction to manage the patient's behavior or restrict the patient's freedom of movement and is NOT a standard treatment or dosage for the patient's condition. The application of force to physically hold a patient is considered a restraint; e.g. therapeutic hold in order to administer a medication against the patient's wishes. A drug or medication when it is used as a restriction to manage the patient's behavior or restrict the patient's freedom of movement and is not a standard treatment or dosage for the patient's condition...

V. POLICY It is the policy of this facility to ...B. Prevent, reduce, and eliminate the use of restraints by basing use on the patient assessed needs: ...iii. Limiting the use of restraints and seclusion to emergencies where there is a risk to the patient harming himself/herself or others.

The hospital's Restraint and Seclusion Policy included: "...J. QUALITY IMPROVEMENT PROCESS...Leadership determines our facility's approach to the use of restraint and seclusion, which limits its use to those situations where there is appropriate clinical justification by...ix) Development and promotion of policies and procedures regarding the proper use of restraints...Our facility collects data on the use of restraints and seclusion in order to monitor and improve its performance of processes that involve risks and may result in sentinel events...We analyze data by...i) Aggregating data at least quarterly...ii) Collecting data on all restraint episodes...."


Patient #1:

Patient #1 became confused after returning from an MRI on 07/07/2023. The patient wanted to leave and resisted staff attempts to redirect the patient back to bed. Documentation in the clinical record revealed the patient became combative and was physically held by a Security Officer and administered Geodon 10 g IM at 10:40 p.m. to control the patient's behavior and prevent [him] from attempting to leave.

Patient #9:

Patient #9's clinical record included nursing documentation dated 06/22/2023 at 6:55 p.m. which included: "...Pt very anxious constantly trying to get out of bed. IV ativan ordered and given. Pt became more agitated and combative towards staff. Order for IV haldol and soft restraints...." A review of the provider order revealed a one time order for Ativan 1 mg intravenous (IV) push and an order for Haldol 5mg IV push which could be administered every 4 hours as needed for agitation or anxiety.

The patient had another episode of combative and agitated behavior on 06/23/2023 and was transferred to the Intensive Care Unit. The patient was administered sedation (Precedex) for a period of over 24 hours to control the patient's behavior.

Patient #11:

Patient #11 was documented to be combative and verbally aggressive on 06/25/2023. A Code Grey was activated and the patient was physically held by a Security Officer so that staff could administer medications. Documentation in the Medication Administration Records revealed the patient was administered two antipsychotic medications: Geodon 20 mg was administered IM at 12:10 a.m. and Haldol 5 mg was administered IM at 12:15 a.m. to control the patient's behaviors and prevent her from getting out of bed.

Patient #14:

Patient #14 was documented to be combative and "violent" in the ED on 07/24/2023 The patient was physically held by a Security Officer and and then administered Haldol 5 mg IM and then Ativan 2 mg and Haldol 5 mg IM at approximately 10:15 p.m. to control the patient's behaviors and prevent [him] from leaving.

A review of the hospital's documentation of restraint usage revealed data was collected and reported for the months of January, February, and March 2023. There was no documentation of data collected and reported after that.

Staff #8, a Nurse Educator, reported during a subsequent interview that chemical restraints were not used in the hospital.

Interviews conducted during the survey with Staff #2 revealed the data collected was on the use of mechanical restraints only. Staff #2 reported during the interviews that there was no data collected on the use of physical holds by staff including Security Officers or data collected on the use of chemical restraints as defined in their restraint policies and procedures. Staff #2 also reported the data that was collected had not been analyzed.

Based on record reviews and staff interview, it was determined the hospital:

1. Failed to perform a complete analysis of Patient #1 being physically held by a Security Officer (SO). A Security Officer held Patient #1's arms behind [his] back while sitting in a chair for approximately 15 minutes. The hospital's investigation did not identify there was no physician's order for the physical hold; the Security Officer's restraint training certificate had expired; and the hospital's restraint policies did not allow for Security Officers to be involved in restraints.

2. Failed to ensure an event report was generated and investigated for Patient #2 who was an elderly, cognitively impaired person who eloped from the Emergency Department.

Findings include:

The hospital's Event Reporting Policy included: "...A patient safety event is an event, incident, or condition that resulted or could have resulted in harm to a patient. Patient safety events also include adverse events, no-harm events, close calls (near misses), and hazardous conditions. Any injury caused by medical care or could have been caused by medical care...Patient safety event types in ERS (Event Reporting System)...are generally categorized as follows:...Behavioral - Patient Protection Events, Elopement...Aggressive/violent behavior..."

1. Refer to Tag A-0154 for specific details related to Patient #1. Patient #1 was admitted to the hospital on 07/06/2023. The patient was described as alert and oriented to self, place and time at the time of admission as well as being cooperative with staff. The patient returned from an attempted MRI on the evening of 07/07/2023 and became increasingly agitated attempting to leave. The patient resisted staff efforts to redirect the patient, and it was documented that he became combative. At that time a "Code Grey" was called. A Security Officer (Staff #7) responded and physically held the patient in addition to other staff holding the patient in the chair. There was no physican orders for the physical hold by the SO or other staff. The patient was also chemically restrained and rapidly deteriorated and transferred to the ICU where [he] was assessed to have bruises and lacerations on [his] arms and legs.

The SO's report included: "...On 07/07/2023 at approximately 2225 I ...was called to a Code Grey at [Patient #1's Room number.]. When I arrived I found the patient being aggressively resistant with medical staff as they urged [him] to return to his bed. As [he] was placed in a chair he began to swat randomly at staff. I placed the patient in a PRT (Primary Restraint Technique) as [his] wrist IV negated the option of wrist holds. [He] continued to be aggressive with staff as orders for medication were placed. [He] was held in this sitting position for over 15 min which resulted in my being in a bent twisted position holding [him] in the restraint. After medication was administered [he] was transferred back to [his] bed with no further assistance from security ...."

A separate event report was generated based on concerns presented to the hospital by family member(s) who were present and witnessed the above incident. The documented investigation of the incident revealed the focus of the investigation was whether or not the SO used "excessive force" during the physical hold. The findings of the investigation was that "excessive force" was not used, and the investigation was closed.

An interview was conducted with Staff #7 on 08/21/2023 3:15 p.m. interview with Staff #7. Staff #7 reported that part of [his] role is to restrain patients including holding patients to control their behavior. [He] was asked if [he] takes direction from a Registered Nurse in those situations, and [he] responded that [he] does so on [his] own without direction from staff.

An interview was conducted with the Director of Security (Staff #6) on 08/21/2023. Staff #7's personnel record was reviewed during the interview. Documentation in the personnel record revealed a Handle with Care De-escalation Certificate that expired on 10/31/2022. Staff #6 reported the Security Officers were taught some holds as well as de-escalation techniques. Staff #6 stated [he] was aware of the expired certificate and was in the process of getting the Security Officers scheduled to update the training.

The hospital's Restraint and Seclusion policies and procedures did not include the provision for Security Officers to use physical holds to patients. A review of the Position Description for Security Officers revealed no documentation for Security Officers to particpate in restrainting patients.

Staff #2 and Staff #3 reported during an interview that 08/22/2023 that the hospital's investigation of Patient #1's incident of being physically restrained by a SO was not thorough and did not identify failures to follow policies and procedures in multiple areas.

Patient #2:

Patient #2 was taken to the Emergency Department by emergency services on [07/11/2023 ]at 2:50 a.m. The patient was triaged by a Registered Nurse (RN) who documented the patient was sent from an assisted living home because of combative behavior. The patient was described to be alert and oriented to self only. The patient was evaluated by an ED physician at 2:50 a.m. and a behavioral health evaluation was performed at 4:05 a.m. Documentation in the behavioral health evaluation revealed the patient had eloped from the assisted living facility shortly after admission. The evaluation revealed the patient had a history of Alzheimer's Disease and was confused, forgetful, and cognitively impaired. The patient repeatedly voiced his/her concerns during the evaluation that his/her parents did not know where s/he was and would not know where to pick him/her up. The behavioral health evaluation recommendation was acute inpatient psychiatric placement. A nurse's note at 4:50 a.m. included: "Denies any needs. At 5 a.m. the nurse documented the patient was not in his/her room and that the Charge Nurse and Security staff were notified. The patient was located "wandering" approximately two miles from the hospital by local law enforcement and returned to the hospital at 6:58 a.m.

The surveyor requested the event report for the above incident. Staff #1 reported there was no event report generated. Staff #2 reported an event report should have been generated.

Based on record reviews and staff interviews, it was determined the governing body failed to ensure adequate resources were allocated to sustain the hospital's Quality Assessment and Performance Improvement Plan to collect and analyze data and implement processes to increase desired outcomes for the provision of quality and safe care to patients.

Findings include:

The hospital's Quality Assessment and Performance Improvement (QAPI) Plan included: "...The Board of Trustees (BOT), Medial Staff, and Administration have the overall responsibility and accountability for the quality of care and services provided to increase the probability of achieving desired outcomes to meet the needs of patients and other customers. Northwest Medical Center's Leaders manage performance improvement through planning, setting priorities, and providing resources necessary to empower and promote collaboration...Administration has responsibility for the provision of patient care and services provided by the hospital. The committees, departments and improvement teams are responsible for the delivery and evaluation of care and service they provide on an on-going basis. Administration will provide the resources and education to empower the culture of continuous performance improvement..Quality Improvement Committee (QIC) is responsible for implementing the QAPI Plan, which provides the framework for quality improvement and patient safety throughout the hospital. It is designed to provide leadership and direction for ongoing support of improvement efforts. Membership consists of the Executive Team and Medical Staff Representative(s), and Quality Leaders...The Committee analyzes and prioritizes activities of the various aspects of quality monitoring, performance improvement, and consistently reviews the effective ness of interventions put in place...."

The Position Description for Chief Quality Officer Market included but was not limited to the following functions:

"-Implements organization best practices and standards for quality, ensuring an environment of accountability that results in achievement of compliance requirements, safety goals and quality benchmarks set by the organization, including but not limited to hand hygiene.

-As a scheduled activity, involves all employees to proactively identify risk mitigation and improvement opportunities, resulting in documented improvements in safety and quality practices.

-Creates a service culture that results in achievement of organizational metrics for patient/customer satisfaction.

-Analyzes data collection of successes and failures to generate on-going improvements which measurably improve the organization ' s patient/customer experience.

-Creates a culture that earns employee commitment as measured by retention and employee satisfaction goals, and is in alignment with sound management practices, applicable laws and NMC values.

-Implements talent acquisition and employee development practices that result in stability of key organization competencies and leadership succession.

-In coordination with appropriate leaders, assesses market and business conditions to identify and execute strategies that create or support growth opportunities.

-Ensures the roll out of tactical action plans, individual goals and accountability measures that result in successful execution of organization goals.

-Manages daily operations with accountability for achieving targeted levels of growth, budget and additional specified short and long term financial objectives.

-Accountable for ensuring sound commitments on behalf of the organization, including clear scope of work, appropriate risk assessment and adherence to reasonable business practices and organization standards."

An interview was conducted with the "Interim" Chief Quality Officer (CQO) (Staff #2). Staff #2 was asked to explain [her] responsibilities in the organization. Staff #2 explained that in addition to [her] responsibilities as CQO at Northwest Medical Center, [she] is also responsible for the QAPI Program at a separately licensed hospital within the organization (Hospital #2). Hospital #2 is a 146-bed acute care hospital located approximately 11.5 miles from Northwest Medical Center. Staff #2 further reported [she] is also the CQO and Director of Risk Management at Hospital #3 and Hospital #4. Hospital #3 is a separately licensed acute care hospital with 44 beds approximately 22 miles from Northwest Medical Center. Hospital #4 is a separately licensed acute care hospital with 18 beds and approximately 30 miles from Northwest Medical Center.

The job functions documented in the Position Description for "Dir Mktg Risk Mgt- Reg Compliance" included but was not limited to the following:

"-Functions as the Patient Safety Officer for the organization and as the primary contact for the patient safety program.

-Implements organization best practices and standards for quality, ensuring an environment of accountability that results in achievement of compliance requirements, safety goals and quality benchmarks set by the organization.

-Creates a service culture that results in achievement of organizational metrics for patient/customer satisfaction.

-Analyzes data collection of successes and failures to generate on-going improvements which measurably improve the organization ' s patient/customer experience.

-Creates a culture that earns employee commitment as measured by retention and employee satisfaction goals, and is in alignment with sound management practices, applicable laws and NMC values.

-Implements talent acquisition and employee development practices that result in stability of key organization competencies and leadership succession.

-In coordination with appropriate leaders, assesses market and business conditions to identify and execute strategies that create or support growth opportunities.

-Ensures the roll out of tactical action plans, individual goals and accountability measures that result in successful execution of organization goals.

-Manages daily operations with accountability for achieving targeted levels of growth, budget and additional specified short and long term financial objectives.

-Accountable for ensuring sound commitments on behalf of the organization, including clear scope of work, appropriate risk assessment and adherence to reasonable business practices and organization standards...."

A review of the QIC monthly meeting minutes for 2023 revealed the meetings were canceled in January, March, May, and August. There was no documentation as to why the meetings were not able to be rescheduled at some time during those months. Staff #2 stated [she] was aware of four of eight QIC scheduled meetings for 2023 were canceled.

Based on record reviews and staff interviews, it was determined the hospital failed to provide organized nursing services 24-hours per day to assess the individual needs of each patient and deliver and supervise the care required in accordance with physician orders, policies and procedures and nursing standards of care as evidenced by:

Tag A-0395: A registered nurse must supervise and evaluate the nursing care for each patient.

The hospital failed to ensure a Registered Nurse supervised and managed the care during physical holds by Security Officers of Patients #1, #11 and #15. Patients #1 and #15 sustained injuries during the physical holds. Patient #2 presented to the Emergency Department and had a diagnosis of Alzheimer's Disease. The patient was able to elope from the ED and was found wandering by law enforcement approximately two miles away.

The effect of this deficient practice prevented the patients from receiving quality healthcare in a safe environment.

Based on record reviews and staff interview, it was determined the hospital failed to ensure a Registered Nurse supervised and managed the care during physical holds by Security Officers of Patients #1, #11 and #15. Patients #1 and #15. sustained injuries during the physical holds. Patient #2 was a cognitively impaired senior patient who was not appropriately monitored and eloped from the Emergency Department.

Findings include:

The hospital's Restraint and Seclusion Policy included: "...It is the policy of this facility to...B. Prevent, reduce, and eliminate the use of restraints by basing use on the patient's assessed needs...Limiting the use of restraints and seclusion to emergencies where there is a risk to the patient harming himself / herself or others. Though patients have the right to refuse treatment, under certain circumstances, if serious bodily harm is judged to be imminent, (e.g. violent patient) an R.N., after assessment of the patient should institute the use of restraint, which he/she believes ill protect the patient and/or others effectively...."

Refer to Tag A-0154 for specific details related to the following patients.

Patient #1 was taken to the hospital's Emergency Department on 07/06/2023 after becoming dizzy and falling at home. The patient was described to be alert, oriented, and cooperative with normal mood and affect. The patient was admitted for further evaluation and treatment. Nursing documentation dated 07/07/2023 at 11 p.m. included:

"Ativan ordered and given before MRI.
MRI brain not able to be completed due to agitation as stated per MRI tech around 2200 patient became combative, becoming very restless.
Charge RN, staff, and this RN were doing best to comfort and redirect patient back to room.
Code grey called.
Patient with nausea-benadryl given for relief
Geodon given due to situation.
Once back into bed-emesis episodes recurrent-suctioned patient as needed and kept patient upright, breathing slowed, new garbled and imprecise speech with communication was noted
patient vitals monitored in meantime before transfer to ICU..."

There was no nursing documentation that described the events of the Code Grey. Documentation in an event report revealed a Security Officer (Staff #7) responded to the Code Grey. Staff #7 physically restrained the patient by holding the patient's arm behind the patient's back who was being held down by staff in a chair. Documentation in Staff #7's report revealed the patient's hold lasted for a period of fifteen to twenty minutes. There was no documentation in the clinical record that a provider's order was obtained for the physical hold by Staff #7. There was no documentation Staff #7's physical hold of the patient was at the direction of the RN. There was no nursing documentation that identified there were other staff involved in holding the patient down. There was no nursing documentation that an RN physically assessed the patient for injuries after the patient was able to be placed back into bed and [he] rapidly deteriorated. The patient was assessed with, "... multiple skin tears and bruises/ecchymotic all over bilateral arms and legs" after arrival to the Intensive Care Unit.

Staff #7 reported during an interview that [he] made the decision to hold the patient with [his] arms behind [his] back and it was not at the direction of an RN.

Patient #2 was taken to the Emergency Department (ED) by emergency services on from an assisted living home. The patient was described to be alert and oriented to self only. The ED Report revealed the patient had a history of Alzheimer's Disease and was confused, forgetful, and cognitively impaired. A nurse's note at 4:50 a.m. included: "Denies any needs. At 5 a.m. the nurse documented the patient was not in his/her room and that the Charge Nurse and Security staff were notified. The patient was located "wandering" approximately two miles from the hospital by local law enforcement and returned to the hospital at 6:58 a.m.

Patient #11:

Patient #11 was a patient over the age of [75] year admitted to the hospital on 06/16/2023. Nursing documentation on 06/25/2023 at 4:48 a.m. included: "At around 2230 patient became combative and verbally aggressive. Hospitalist was aware and orders were received. Patient then became more combative. patient bit one RNN [sic] twice and kicked another Rn on the head upon assisting with patient care. Code gray was called. Dr. (name) came at bedside more orders were received...." The Security report revealed a Security Officer (Staff #9) responded and , "...assisted medical staff restrain patient while medical staff administered meds...."

There was no documentation in the clinical record that explained how the Security Officer assisted medical staff in restraining the patient. There was no documentation in the record that the Security Officer's actions as well as other staff were at the direction of the RN.

Patient #15:

Patient #15 was a minor patient under the age of 18 taken to the ED by the responsible family member on 06/19/2023 at 8:13 p.m. The patient had a history of depression, aggressive behavior and past inpatient psychiatric admission. The patient became violent with staff while still in the lobby. Security staff were called for assistance. The patient continued to be aggressive with the SO, and the patient fell and hit [his] head and face on the tile floor causing: "... swelling abrasions overlying the left aspect of the forehead as well as the bridge of the nose There is also abrasions and scratch marks on the upper extremities as well as on the knuckles of the bilateral upper extremities..." The SO's documentation of the incident revealed the SO held the patient against the wall at one point. The patient tried to break away from the SO's and staff's physical hold while taking [him] back to the ED. The patient slipped on the tile floor causing the SO and the staff to fall to the floor.

There was no documentation in the record that an RN directed the SO's actions specific to the manner of restraints used by the SO.

Staff #7 stated during an interview on 8/22/2023 that [he] makes [his] own decisions for the use of physical holds/restraints on patients.