HospitalInspections.org

Based on medical record review, Idaho code review, incident report review, security video review, ED staff communication review, FDA guidelines review, hospital policy review, patient interview, and staff interview, it was determined the hospital failed to ensure patients' rights were protected and promoted. This directly impacted the safety of 3 of 7 patients (Patients #1, #2, and #3 ) whose records were reviewed. This resulted in patients not being kept safe and had the potential to affect all patients receiving care at the hospital. Findings include:

Refer to A-0131 as it relates to the facility's failure to ensure patients and guardians were allowed to make informed decisions about care.

Refer to A-0145 as it relates to the facility's failure to ensure all patients were kept free from physical abuse and harassment.

Refer to A-0154 as it relates to the facility's failure to ensure restraints and/or seclusion were only imposed to ensure the immediate physical safety of the patient or others and were discontinued at the earliest possible time.

Refer to A-0160 as it relates to the facility's failure to ensure facility staff followed hospital policy or nationally recognized standards for the use of chemical restraints.

Refer to A-0162 as it relates to the facility's failure to ensure the use of seclusion was used appropriately

Refer to A-0168 as it relates to the facility's failure to ensure restraints were ordered by licensed practitioners.

Refer to A-0170 as it relates to the facility's failure to ensure the physician was consulted when the restraint was not ordered by the physician.

Refer to A-0178 as it relates to the facility's failure to ensure patients were seen face to face by a physician or LIP within 1 hour of initiation of a violent restraint.

Refer to A-0186 as it relates to the facility's failure to ensure least restrictive alternatives were attempted and documented prior to the application of restraints.

The cumulative effect of these negative systemic practices impacted patients' rights and had the ability to affect all patients receiving services at the hospital.

Based on staff interview, review of Idaho code, incident report review, hospital policy review, medical records review, and security camera video review, it was determined the hospital failed to ensure the rights were protected for 2 of 5 patients (Patient #2 & #3) who were placed on involuntary holds and whose records were reviewed. This resulted in the unlawful detainment of Patient #3 and failure to contact a State appointed guardian for Patient #2. Findings include:

Idaho code 66-326 includes, "no person shall be taken into custody or detained as an alleged emergency patient for observation, diagnosis, evaluation, care or treatment of mental illness unless and until the court has ordered such apprehension and custody under the provisions outline in section 66-329 ... Whenever a person is taken into custody or detained under this section without court order, the evidence supporting the claim of grave disability due to mental illness or imminent danger must be presented to a duly authorized court within twenty-four (24) hours from the time the individual was placed in custody or detained."

The Idaho code continues, "If the court finds the individual to be gravely disabled due to mental illness or imminently dangerous under subsection (1) of this section, the court shall issue a temporary custody order requiring the person to be held in a facility, and requiring an examination of the person by a designated examiner within twenty-four (24) hours of the entry of the order of the court ... If no petition is filed within twenty-four (24) hours of the designated examiner's examination of the person, the person shall be released from the facility."

Idaho code 66-329 includes, "COMMITMENT TO DEPARTMENT DIRECTOR UPON COURT ORDER - JUDICIAL PROCEDURE. (1) Proceedings for the involuntary care and treatment of mentally ill persons by the department of health and welfare may be commenced by the filing of a written application with a court of competent jurisdiction by a friend, relative, spouse or guardian of the proposed patient, by a licensed physician, by a physician assistant or advanced practice registered nurse practicing in a hospital, by a prosecuting attorney or other public official of a municipality, county or of the state of Idaho, or by the director of any facility in which such patient may be.

(2) The application shall state the name and last known address of the proposed patient ... and a simple and precise statement of the facts showing that the proposed patient is mentally ill and either likely to injure himself or others or is gravely disabled due to mental illness.

(3) Any such application shall be accompanied by a certificate of a designated examiner stating that he has personally examined the proposed patient within the last fourteen (14) days and is of the opinion that the proposed patient is: (i) mentally ill; (ii) likely to injure himself or others or is gravely disabled due to mental illness; and (iii) lacks capacity to make informed decisions about treatment."

Patients were held in the hospital against their will without following hospital policy and state law. Examples include:

1. Patient #3 was a 40 year old female who was admitted to the ED on 7/17/23 and was in the ED for over a month. She had diagnoses including TBI, PTSD, depression, and a developmental delay.

Patient #3's medical record included a form titled, "Affidavit supporting the need for detainment without a hearing Mental Health Hold." The form included Patient #3, "Appears to be gravely disabled due to a mental illness as evidenced by:

- Unable to communicate basic needs
- Substantial risk of continued physical. Emotional or mental deterioration
- Lacks insight into the need for treatment lacks ability to provide for one's basic needs and make safe decisions."

Patient #3's medical record did not include any documentation the above hold paperwork was submitted to the state court. There was no documentation a DE examined Patient #3 and agreed with the above opinion.

A security incident by Staff C from 7/29/23 was reviewed and stated, "SO [Name], [name], and I entered her room and calmly explained to her that if she did not willingly take her medication it would be administered to her through a shot. [Patient #3 name] was yelling at us that she refused to take it and that she could 'not take it with water' after several minutes of back and forth dialogue, nurse [name], decided to give the shot. SO [name] used open hand control on her right arm, and I used open hand control on her left arm. Nurse [name] administered the medication in her right upper arm."

A physician note from 8/12/23 stated, "As pt is own guardian, can legally refuse non emergency medications ... ok to reoffer medications several times."

A security video of an incident on 8/11/23 was reviewed by surveyors on 9/27/23 beginning at 1:37 PM. The video showed Patient #3 in a discussion with security officers in the hallway of the ED next to the nurse's station. There was no sound on the video. Patient #3 attempted to walk around the officers in the hallway. At that point officers put hands on her and she was taken to the ground. Patient was observed sitting on the ground and appeared to be talking to the officers. A CNA was observed coming into video with a wheelchair. Security was then observed picking Patient #3 up and putting her in to the wheelchair, holding her in the wheelchair and taking her back to her room.

Staff B was interviewed on 9/28/23 beginning at 10:00 AM. He was asked if Patient #3 was allowed to leave her room. He stated "yes and no." He said she was only allowed to leave her room with staff present. He stated she was not allowed to "come out and sit in the hallway. There was too much going on for her to be out there." Additionally, in regards to placing the patient back in her room against her will he stated "its much easier to control someone in their room, a smaller space."

Staff G was interviewed 9/28/23 beginning 10:17 AM. When asked if Patient #3 was allowed to leave her room in the ED, he stated he was unsure if the ED manager specifically said that but he stated, "from what I saw they wanted her kept in her room."

Staff A was interviewed on 9/26/23 beginning at 2:22 PM and Patient #3's record was reviewed in his presence. When asked if Patient #3 was evaluated by a DE he stated "no." When asked why Patient #3 was not evaluated by a DE he stated she "was on a physician hold" or "medical hold," and court ordered holds "come through the police." He stated DE evaluation was not required on physician holds.

The Medical Director was interviewed on 9/26/23 beginning at 3:30 PM. When asked what a "medical hold" was used for, he stated when a patient is harmful to self or others not due to a psychiatric diagnosis. He stated it was used for people who had a developmental disability or cannot make decisions on their own. He stated he didn't believe the DE or State was involved in the process for a "medical hold."

The facility failed to ensure Patient #3 was allowed to refuse treatment. The hospital deprived Patient #3 of her physical freedom and her ability to participate in her care. When she attempted to leave, the hospital detained her and then failed to notify the court which prevented her from receiving due process.

2. The facility failed to contact state appointed guardian or custodians who could act on behalf of a committed patient.

A facility policy titled, "Detaining Patients Who Lack Capacity to Provide Informed Consent," dated 10/14/22 included:

"If it is determined by the physician that a patient is a potential harm to self or others the patient will be detained for treatment of a medical illness due to a concern regarding the patient's capacity to make reasoned decisions on their behalf, careful action must be taken to maintain the patients' rights ...

v) does the patient have a guardian, living will, or durable power of attorney for healthcare that would support treatment or patient's decision to refuse treatment? ...

vi ) Contact and discussion with patient, family members or surrogate decision makers that may be available to act on the patients' behalf.

vii) Contact and discussion with state and community organizations who could act on behalf of the patient as appropriate."

This policy was not followed. An example includes:

Patient #2 was a 27 year old male with diagnoses including, ADHD, Autism, Bipolar disorder, and depression. Patient #2 was committed to the State of Idaho which included a state appointed custodian who could act on his behalf. Patient #2 was being held in the ED awaiting placement at an appropriate care facility that could care for him. At the time of survey Patient #2 had been in the ED awaiting placement for approximately 22 days.

Patient #2's medical record was reviewed. It included a court order for Patient #2 that he was committed to the State of Idaho. There was no documentation the State appointed guardian or custodian was contacted who could act on behalf of Patient #3

Patient #2's medical record included a psychiatric consult dated 9/05/23, signed by a DO. The note included that Patient #2 was brought in by staff [residential treatment facility] staff. He was brought in due escalating violent behavior. The note also included that Patient #2 had a State appointed guardian and possibly his mother was his guardian.

Patient #2's medical record included a form titled, "Communication of Need to Detain a Patient for Emergent Hospital, Medical, Dental or Surgical Care." The form included:

"A surrogate decision maker was not contacted; Reason why a surrogate was not contacted: unavailable."

Additionally, the form included "nature of emergent care required: psychiatric evaluation."

It was unclear through the documentation reviewed why Patient #2 was not placed on a psychiatric hold and the state DE was not notified.

An ED Physician was interviewed on 9/27/23 beginning at 11:25 AM. When asked about the hospital's hold procedure he stated a "medical hold" required no State or DE involvement.

The Facility Medical Director was interviewed on 9/26/23 beginning at 3:30 PM. When asked when a medical hold was used he stated when a patient is harmful to self or others, but it is not due to a psychiatric diagnosis. He stated it is use for people who have a developmental disability or cannot make decisions on their own. He stated he didn't believe the DE or State was involved in the process.

Staff A was interviewed on 9/28/23 beginning at 1:30 PM and Patient #2's medical record was reviewed in his presence. He confirmed there was no documentation of contact with Patient #2's state appointed guardian or other guardian who can act on behalf of Patient #2.

Staff L who was caring for Patient #2 during survey was interviewed on 9/27/23 beginning at 11:00 AM. When asked if Patient #2 could leave the facility she stated "no." When asked if there had been any DE or State involvement she stated "I don't think so."

The facility failed to ensure Patient #2's state appointed guardian or custodian was contacted to act on his behalf.

Based on medical record review, incident reporting review, and staff interview, it was determined the facility failed to ensure patients were free from abuse and harassment for 1 of 2 patients (Patient #3) with a developmental disability whose records were reviewed. Additionally, ED management was made aware of the issue but failed to address it. This caused unnecessary emotional distress and potential physical harm to Patient #3. Findings include:

Patient #3 was a 40 year old female who was admitted to the ED on 7/17/23 and was boarded in the ED for over a month. She had diagnoses including TBI, PTSD, depression, and a developmental delay.

1. The facility failed to protect patients from harassment.

Multiple incidents of harassment and threats by staff were documented through Patient #3's record and incident reports as follows:

- Incident report from 8/10/23: "Patient [Patient #3 name] was using her phone and calling 911 and they [ED staff] wanted the phone taken from her ... [Patient #3 name] was sitting on her bed when SO [name] and myself went in to get the phone. I asked her to give me the phone as she was abusing it and interfering with care. She immediately shoved the phone down the front of her pants ... I went to find a female to come with us to get the phone. [ED staff name] had come back so I asked her to accompany use. I reiterated that we needed the phone and that she had options to hand it to us or we would hold her down and [ED staff name] would get the phone."

- Incident report 8/11/23 by Staff G: "One of the security officers got right up into the patients face continuing to 'escalate' the patient ... this situation did not need to happen and in my opinion happens more and more due to the lack of de-escalation training, the heavy handed approach by security." Additionally, this incident was signed off by the ED Manager, Staff A, stating, "Investigation into this incident revealed that video did not support the accusations in the trideo [incident report]. ED director met with RN involed [sic] and relayed the information. RN was encouraged to work as a team with security as well."

- MD note from 8/12/23: "Behavioral dysregulation yesterday escalated in setting of severely inappropriate staff responses ... Review events from yesterday and apologize to pt for staff's inappropriate response. Pt says she feels 'badly' for how she was treated."

- RN note from 7/24/23: "This RN asked the clerk to call security ... The ED provider stated that security will antagonize the pt more. Security was called off."

Staff G was interviewed on 9/28/23 at 10:17 AM. He stated security accosted Patient #3. He stated security got in Patient #3's face. He stated, "I feel like we're the ones that created the problem." He stated with he wrote this information in Patient #3's chart, and one of the ED managers, Staff K, questioned why he would document that in the chart and told him to get approval before charting things like that.

Staff A was interviewed on 9/28/23 at 1:31 PM. When asked if he was aware of ED staff and security staff antagonizing Patient #3, he stated he had not had any conversations about it. The last line of the incident report by Staff G was read to Staff A which stated the situation was avoidable, and security was heavy handed and lacked de-escalation training. He stated he did not speak to Staff G regarding the incident, he stated the other ED manager talked to Staff G. When asked why his name was documented in the incident report he stated, "yeah, I responded to the trideo [incident report]."

The facility failed to prevent harassment of a patient by hospital staff.

2. Hospital staff assaulted a developmentally delayed patient.

ED incident reports were reviewed. An incident documented by Staff G regarding Patient #3 on 8/11/23 was reviewed and stated:

"The patient pretended to spit in the security face, then the security slammed the patient backwards on the bed in the room and the male ED tech jumped directly onto the patient rather forcefully. I pulled the ED tech off of the patient, and he walked out of the room. I asked the security at this time to please leave the room and I was able to de-escalate the patient."

Staff G was interviewed on 9/28/23 at 10:17 AM regarding the incident with Patient #3. He stated when Patient #3 was brought back to her room, security got up in her face and Patient #3 acted like she was going to spit. He stated the ED tech, Staff H, jumped on top of Patient #3 and he had to pull Staff H off her. He stated he told security to leave the room and was able to calm her. He stated he felt hospital staff caused Patient #3's behaviors.

Staff H, the ED tech, was interviewed on 9/28/23 beginning at 11:24 AM and the incident regarding Patient #3 was reviewed with him. He confirmed he was present for the incident. He stated Patient #3 spat on a security guard, and then he jumped on top of Patient #3 and tried to push her head down. He confirmed a nurse pulled him off Patient #3. When asked why he believed jumping on top of Patient #3 to be an acceptable response to the situation he stated, "that was just natural instinct," and, "I wasn't aggressive. I saw the situation and tried to get it further from escalating." He stated he talked to Staff A, the ED manager, about the incident and his response was, "that's the best you could have done, you weren't too aggressive."

Staff A, the ED manager, was interviewed on 9/28/23 at 1:31 PM. The incident with Patient #3 and the interview with Staff H was reviewed with him. When asked if jumping on top of a patient was an appropriate response to the situation he stated, "If a patient is hitting and biting we may have to restrain them that way." When asked if he taught jumping on top of patients as a form of restraint he said, "no."

The hospital failed to protect patients from abuse.

3. ED management was aware of patient abuse but failed to address it.

ED incident reports were reviewed. An incident documented by Staff G regarding Patient #3 on 8/11/23 was reviewed and stated:

"The patient pretended to spit in the security face, then the security slammed the patient backwards on the bed in the room and the male ED tech jumped directly onto the patient rather forcefully. I pulled the ED tech off of the patient, and he walked out of the room. I asked the security at this time to please leave the room and I was able to de-escalate the patient."

The incident report included a comment from the ED manager, Staff A, which stated, "Investigation into this incident revealed that video did not support the accusations in the trideo [incident report]. ED director met with RN involed [sic] and relayed the information. RN was encouraged to work as a team with security as well." Additionally, the incident report included a note from the Security Manager which stated, "the video documents that a difficult situation was handled appropriately by the staff involved."

Staff H, the ED tech, was interviewed on 9/28/23 beginning at 11:24 AM and the incident regarding Patient #3 was reviewed with him. He confirmed he jumped on top of Patient #3 and a nurse pulled him off. He stated he told Staff A about the incident and the response from Staff A was, "that's the best you could have done, you weren't too aggressive."

Staff A, the ED manager, was interviewed on 9/28/23 at 1:31 PM and was asked about the incident with Patient #3. When asked about Staff H jumping on top of Patient #3 and pushing her head down, he stated Staff H talked to him the day after the incident, but he didn't realize Staff H jumped on her. When surveyors reviewed the part of the incident report, signed off by the ED manager, which stated Staff H jumped on top of Patient #3, he replied, "Apparently I missed that part."

ED Management was made aware of abuse but failed to address it.

Based on medical record review, incident reporting review, and staff interview, it was determined the facility failed to ensure contracted security staff applied patient restraints under the direction of hospital clinical staff to ensure appropriate use of restraints and seclusion related to ED patients. Additionally, oversight and review of contracted security staff actions related to potential patient harassment was not documented. This failure had the potential for all patients seeking care in the ED to be placed in unnecessary restraints and/or seclusion without hospital clinical oversight, and placed ED patients at risk for harassment from contracted security staff. Findings include:

1. Refer to Security Incidents including the application of restraints and seclusion cited at A - 0162 and A - 0168

2. Multiple incidents of harassment and a threat by security staff were documented through Patient #3's medical record and incident reports as follows:

- Incident report from 8/10/23: "Patient [Patient #3 name] was using her phone and calling 911 and they [ED staff] wanted the phone taken from her ... [Patient #3 name] was sitting on her bed when SO [name] and myself went in to get the phone. I asked her to give me the phone as she was abusing it and interfering with care. She immediately shoved the phone down the front of her pants ... I went to find a female to come with us to get the phone. [ED staff name] had come back so I asked her to accompany use. I reiterated that we needed the phone and that she had options to hand it to us or we would hold her down and [ED staff name] would get the phone."

- Incident report 8/11/23 by Staff G: "One of the security officers got right up into the patients face continuing to 'escalate' the patient ... this situation did not need to happen and in my opinion happens more and more due to the lack of de-escalation training, the heavy handed approach by security." This incident was signed off by the ED Manager, Staff A, stating, "Investigation into this incident revealed that video did not support the accusations in the trideo [incident report]. ED director met with RN involed [sic] and relayed the information. RN was encouraged to work as a team with security as well." This incident was also signed off by the Security manager who wrote, "The video documents that a difficult situation was handled appropriately."

- MD note from 8/12/23: "Behavioral dysregulation yesterday escalated in setting of severely inappropriate staff responses ... Review events from yesterday and apologize to pt for staff's inappropriate response. Pt says she feels 'badly' for how she was treated."

- RN note from 7/24/23: "This RN asked the clerk to call security ... The ED provider stated that security will antagonize the pt more. Security was called off."

Staff G was interviewed on 9/28/23 at 10:17 AM. He stated security accosted Patient #3. He stated security got in Patient #3's face. He stated, "I feel like we're the ones that created the problem." He stated with he wrote this information in Patient #3's chart, and one of the ED managers, Staff K, questioned him why he would document that in the chart and told him to get approval before charting things like that.

Staff A was interviewed on 9/28/23 at 1:31 PM. When asked if he was aware of ED staff and security staff antagonizing Patient #3, he stated he had not had any conversations about it. The last line of the incident report by Staff G was read to Staff A which stated the situation was avoidable, and security was heavy handed and lacked de-escalation training. He stated he did not speak to Staff G regarding the incident, he stated the other ED manager talked to Staff G. When asked why his name was documented in the incident report he stated, "yeah, I responded to the trideo [incident report]." He stated he was unaware security applied restraints required a order and documentation in the patients record.

The Quality Manager was interviewed on 9/27/23 beginning at 2:00 PM. When asked who the security staff report to she stated the Chief Operating Officer. When asked if Security staff have any clinical oversight in reference to performing clinical duties such as restraints she stated no.

The Vice President of the facility's quality department and the Quality Manger were interviewed together on 9/28/23 beginning at 2:00 PM. When asked if the above security incidents and restraints were reviewed and identified as issues, the VP of Quality stated the facility had identified opportunities for improvement and the facility had created a restraint task force to identify if there is room for improvement. He stated the "task force" was multidisciplinary and had just been started on 9/14/23.

The facility failed to ensure all patients were free from restraint or seclusion and received care in a safe environment.

Based on record review, hospital policy review, staff interview, and FDA guideline review, it was determined the hospital failed to ensure the appropriate use of chemical restraints for 1 of 1 patient (Patient #1) who received a chemical restraint and whose record was reviewed. This failure had the potential to put all patients at risk for negative outcomes. Findings include:
FDA guidelines for Geodon, accessed 10/11/23, stated, "Acute treatment of agitation associated with schizophrenia (intramuscular administration): 10 mg-20 mg up to a maximum dose of 40 mg per day." (www.accessdata.fda.gov/drugsatfda_docs/label/2020/020825s058,020919s045lbl.pdf)
A facility policy titled, "Restraints and Seclusion" dated 5/17/20, included the definition of a chemical restraint as: "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. Medication will not be utilized for chemical restraints. Exception: (2) The drug or medication is used within the pharmaceutical parameters approved by the Food and Drug Administration (FDA) and the manufacturer for the indications that it is manufactured and labeled to address, including listed dosage parameters."
The above guidelines and policy were not followed. An example includes:
Patient #1 was a 38 year old male who presented to the ED on 7/11/23 at 3:11PM, with his case manager, and had been manic for a few days prior to his ED admission.
Patient #1's medical record included an ED note dated 7/11/23 at 3:11 PM signed by an RN that included he was not suicidal nor did he want to hurt anyone else. It stated Security was notified and Patient #1 began to get agitated with staff since he was not allowed to leave. It included that Patient #1 weighed 145 kilos
Patient #1's medical record included he received Geodon 20mg IM at 3:31 PM on 7/11/23.
Patient #1's medical record included he was placed on a mental health hold by the provider on 7/11/23 at 3:45 PM which stated he was "gravely disabled due to a mental illness."
Patient #1's medical record included he attempted to elope on 7/11/23 at 4:55 PM and security was able to bring him back to the ED.
Patient #1 was then given the following medications:
7/11/23 5:03 PM Haldol 5 mg IM
7/11/23 5:03 PM Ativan 2 mg IM
7/11/23 5:03 PM Benadryl 50 mg IM
Patient #1's medical record included he was given Ketamine 500 MG IM on 7/12/23 at 12:43 AM. It included a note from the provider on 7/12/23 at 1:19 AM that Patient #1 "was fairly well controlled for several hours but then became agitated again and was given IM Zyprexa. After 2 hrs [hours] he was still agitated so was given IM Ketamine."
Patient #1's record included an RN note from 7/12/23 at 5:36 AM which included, "PT [patient] was still pacing the room, slamming doors whipping blankets, pushing buttons and punching walls. 500 mg of Ketamin [sic] given @ 0043. Pt fell asleep approx. 20 min after administration. Pt slept until 0430 at that time were able to convince pt to let us acquire labs. He ate a sandwich and started repeating previous behaviors. Pt was again dosed with 500 mg of ketamine. Pt became drowsy but was still thrashing on the floor required someone with him to protect him. Pt was given Geodon @0515. Pt quickly went to sleep. Pt started having a seizure after the dose of Geodon. Vitals were taken, nasal airway inserted. [name] RN started an IV on pt. Plan is to administer Keppra and have access to continue giving medications pt is sleeping, o2 monitor on."
Patient #1's medical record included that he was given a second dose of Ketamine 500mg IM at 4:39 AM and a second dose of Geodon 40 mg IM at 5:15AM.
Patient #1's medical record included a note from the oncoming provider on 7/12/23 at 8:04 AM. It included:
"Patient became agitated again and was a danger to himself. He received a repeat dose of ketamine and Geodon. Patient then had a seizure witnessed by nursing staff which was resolved by the time I got to the room .... Patient was observed in the department and had another episode of convulsions. I decided at that time that patient need to be intubated to protect his airway as he was unable to do so ... Case discussed with [physician name] from intensivist service who will accept the patient for admission"
Patient #1 received Geodon 60 mg IM within 24 hours, above the recommended dosage of 40 mg in 24 hours. Additionally he received 1000 mg of Ketamine within 4 hours
The Hospital's Pharmacist was interviewed on 9/27/23 beginning at 2:00 PM. He confirmed 60 mg of Geodon administered IM to Patient #1 in approximately 14 hours was above recommended dose of 40 MG IM in 24 hours.
The Quality Manager was interviewed on 9/27/23 beginning at 2:00 PM. She confirmed that Patient #1's Geodon and Ketamine medications were not captured as chemical restraint. Additionally, she confirmed that Patient #1's chemical restraints were not logged in the restraint log.
The Risk Manager was interviewed on 9/26/23 beginning at 3:30 PM. When asked about reeducation and any new procedures put in place after identifying this incident, she stated that there was a plan was to add EMR flag to stop drug administration above FDA guidelines. She stated that there was a plan to educate on psychiatric medications.
On exit there was no documentation of these protocol/plans were in place or delivered.
Chemical restraints were utilized in the ED on Patient #1 without being recognized as chemical restraints. Additionally, facility staff failed to follow hospital policy or FDA guidelines for the use of Geodon and chemical restraints.

Based on medical record review, incident report review, hospital policy review, hospital documentation review, patient interview, ED staff communication review, security video review, and staff interview, it was determined the hospital failed to ensure patients' rights were protected and promoted for 2 of 7 patients (Patients #2 and #3). This resulted in care not being provided in a safe setting and had the potential to affect all patients receiving care at the hospital. Findings include:

A facility policy titled "Restraints and Seclusion" dated 5/17/20 included:

"Seclusion is the involuntary confinement of a patient alone in a room or area from which the patient is physically prevented from leaving. A situation where a patient is restricted to a room or area alone and staff are physically intervening to prevent the patient from leaving the room or area is also considered seclusion ... Seclusion may only be used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others."

The policy also included: "When restraint or seclusion is applied, the patients' plan of care must be changed to direct staff on how to care for the patient while in restraint or seclusion and how to prevent further episodes. Patient and families/authorized representative, if appropriate, are educated regarding restraints or seclusion. If restraints or seclusion has been initiated alternatives considered/attempted are shared with the family."

The policy included under the section titled Orders: "An order must be obtained from a physician or credentialed LIP prior to restraint or seclusion use or immediately following restraint or seclusion application in emergency situations. The order must identify date, start time, time limited duration, not to exceed the limit and restraint type." Additionally, the policy included that patients who are secluded must have a face to face evaluation by a physician or LIP or RN trained to conduct face to face examinations within 1 hour of the initiation of seclusion.

This policy was not followed. Examples include:

1. Patient #2 was a 27 year old male with diagnoses including, ADHD, Autism, Bipolar disorder, and depression. Patient #2 was committed to the State of Idaho and had a state appointed guardian. Patient #2 was being held in the ED awaiting placement at an appropriate care facility that could care for him. At the time of survey, Patient #2 had been in the ED awaiting placement for approximately 22 days.

Patient #2's medical record included a psychiatric consult dated 9/05/23, signed by a DO. The note included that Patient #2 was brought in by residential treatment facility staff. He was brought in due to escalating violent behavior. The note also included that Patient #2 had a state appointed guardian and possibly his mother was his guardian.

Patient #2's medical record included a second provider note by an NP that documented he was assessed and recommend further work on stabilizing medication.

At the time of the survey start there was no additional assessment by a physician or advanced practice provider regarding treatment plan or status changes, approximately 19 days after his arrival to the ED.

Staff L was interviewed on 9/28/23 beginning at 12:00 PM. When asked if Patient #2 was allowed to leave his room she stated he was allowed to leave his room to go to the bathroom and to shower but was accompanied by staff. When asked if Patient #2 was freely allowed to leave his room she stated no. When asked what would happen if Patient#2 tried to leave his room she stated staff would redirect him and walk him back into his room. When asked if he had an order to stay in his room she stated, "I don't think so."

Patient #2 was interviewed on 9/28/23 beginning at 12:00 AM. When asked if he was allowed to leave his room in the ED he stated "no." He stated he was allowed to leave sometimes "if I want to walk around."

Staff G, an RN who worked in the ED, was interviewed on 9/28/23 beginning at 10:17 AM. He stated Patient #2 was not allowed to leave his room. He stated ED management sent a message that he was not allowed to leave his room. The message was reviewed during the interview. The message sent on 9/21/23 at 8:11 AM, included, "the pt in bed 15 is to stay in his room. This is non-negotiable." The RN confirmed this was in regard to Patient #2.

Patient #2's medical record did not include an order or clinical indication on why he was not allowed to leave his room or for the use of continued seclusion. Additionally, Patient #2's medical record did not include a face to face evaluation for the use of seclusion or least restrictive alternatives attempted

2. Patient #3 was a 40 year old female who was admitted to the ED on 7/17/23 and was in the ED for over a month. She had diagnoses including TBI, PTSD, depression, and a developmental delay.

Patient #3's medical record was reviewed. It included she was seen by a psychiatric provider on 8/12/23 at 12:13 PM. The note included "behavior dysregulation yesterday escalated in setting of severely inappropriate staff responses ... Reviewed events from yesterday and apologize to pt for staff's inappropriate response. Pt says she feels badly for how she was treated." The note also included "PT struggles with normal circadian rhythm [sleep cycle] due to being in a room without natural light."

A incident for Patient #3 that occurred on 8/11/23 timed at 20:15 was reviewed. It included: "At around 2015 I witnessed patient near room 3 yelling thief at the top of her lungs with 3 male security and male ed tech surrounding her. Patient was somehow knocked to the ground causing an injury to her r [right] elbow. Patient was forcefully placed into a wheelchair while she tried to bit the ED techs hand. The patient was wheeled back to her room #15."

A security video of an incident on 8/11/23 was reviewed by surveyors on 9/27/23 beginning at 1:37 PM. The video showed Patient #3 in a discussion with security officers in the hallway of the ED. There was no sound on the video. Patient #3 attempted to walk aroud the officers in the hallway. At that point officers put hands on her and she was taken to the ground. Patient #3 was observed sitting on the ground and appeared to be talking to the officers. A CNA was observed coming into video with a wheelchair. Security was then observed picking Patient #3 up and putting her in to the wheelchair, holding her in the wheelchair and taking her back to her room.

Staff B was interviewed on 9/28/23 beginning at 10:00 AM. He was asked if Patient #3 was allowed to leave her room. He stated "yes and no." He elaborated she was only allowed to leave her room with staff present. He stated she was not allowed to "come out and sit in the hallway. There was too much going on for her to be out there." Additionally, in regards to placing the patient back in her room against her will he stated "its much easier to control someone in their room, a smaller space."

Staff G was interviewed 9/28/23 beginning 10:17 AM. When asked if Patient #3 was allowed to leave her room in the ED, he stated he was unsure if the ED manager specifically said that but he stated "from what I saw they wanted her kept in her room."

Patient #3's medical record had no order for the use of seclusion or any clinical justification extended use of seclusion was part of her treatment plan. Patient #3's medical record did not include a face to face evaluation for the use of seclusion or least restrictive alternatives attempted.

The facility failed to ensure seclusion was used appropriately for the management of violent or self-destructive behavior in Patients.

Based on medical record review, policy review, incident reporting review, and staff interview, it was determined the facility failed to ensure restraints were ordered by a licensed practitioner for 1 of 1 Patient (Patient #3) who was physically restrained and whose record was reviewed. This caused Patient #3 to have an excessive number of physical restraints placed on her by security officers due to lack of physician involvement and approval of the restraint. Additionally, Patient #3 was put at risk of increased injury due to the excessive amount of restraints used. Findings include:

A facility policy titled, "Restraints and Seclusion," effective 5/17/20 stated, "Definitions ... Restraint: Any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely ... Physical Holding: The application of force to physically hold a patient, in order to administer a medication against the patient's wishes is considered a restraint." It also stated, "a physician/LIP order, from the practitioner responsible for the care of the patient, is required for the application of any restraint."

Patient #3 was a 40 year old female who was admitted to the ED on 7/17/23 and was in the ED for over a month. She had diagnoses including TBI, PTSD, depression, and a developmental delay.

Security reports of all interactions with Patient #3 throughout her stay in the ED were requested. The following physical restraints were used on Patient #3 without an LIP order:

a. A security incident from 7/29/23 was reviewed. It included a 2-point manual hold:

Staff C's report of the event stated, "SO [Name], [name], and I entered her room and calmly explained to her that if she did not willingly take her medication it would be administered to her through a shot. [Patient #3 name] was yelling at us that she refused to take it and that she could 'not take it with water' after several minutes of back and forth dialogue, nurse [name], decided to give the shot. SO [name] used open hand control on her right arm, and I used open hand control on her left arm. Nurse [name] administered the medication in her right upper arm."

Additionally, a physician note from 8/12/23 stated, "As pt is own guardian, can legally refuse non emergency medications ... ok to reoffer medications several times."

b. A security incident from 8/10/23 was reviewed. It included a 4-point manual hold:

Staff C's report of the event stated, "[Staff D], [Staff B], and I were in the ED department posted because [Patient #3] had been acting aggressively and threw orange juice on her one to one. [Patient #3] had her television privileges revoked by staff for her poor behavior. At approximately 17:38 [Patient #3] came out of her room and hit the power button for her TV. ED Tech [Staff E name] stepped forward and told her no she could not watch TV. [Patient #3] grabbed the paper sack out of her garbage can and threw it at [Staff E] and then kicked the garbage can towards her. SO [Staff D name] stepped forward and used open hand control on her left arm and SO [Staff B name] stepped forward to use open hand control on her right arm ... she then lowered her head and bit SO [Staff B name] ... At this point I assisted SO [Staff D name] in taking her to the floor. Once [Patient #3 name] was on the floor I used open hand control on both her ankles while SO [Staff D name] maintained open hand control on her left arm and SO [Staff B name] maintained open hand control on her right arm. SO [Staff B name] asked [Staff E name] to request restraints from Dr. [Staff F name]. Several minutes later Dr. [Staff F name] came into the room and in a very condescending manner said 'Guys, don't treat her like that, just close the door and let her act out ... All three security officers then released [Patient #3 name] and stepped out of the room."

c. A security incident from 8/11/23 was reviewed. It included a 2-point manual hold and an additional manual hold:

Staff I's report of the incident stated, "At this time [Patient #3] walked towards me and attempted to push past me, at which point I grabbed her left arm and [Patient #3] used her bodyweight to fall to the floor. SO [Staff J] got hold of her right arm, after a short moment we decided to try reasoning with her again," and "[Patient #3] was wheeled back to 15 with her arms held to the side of the wheelchair."

Staff J's report of the incident stated, "SO [Staff I name] and E.D. Tech [Staff H name] held her to her bed until she stopped thrashing around."

Staff B was interviewed on 9/28/23 beginning at 10:00 AM and Patient #3's incidents with security were reviewed with him. When asked if holding a patient down was considered a restraint he stated, "yes it is."

The ED Manager, Staff A, was interviewed on 8/28/23 at 1:31 PM and Patient #3's security incidents were reviewed with him and he was asked if the above incidents were considered restraints. He said, "if the patient was held down, yes." He stated there was no restraint documentation in Patient #3's medical record, including a physician's order. He stated he was unaware security applied restraints required an order and documentation in the patients record.

The facility failed to ensure restraints were ordered by a physician.

Based on medical record review, policy review, incident reporting review, and staff interview, it was determined the facility failed to ensure the attending physician was consulted after restraints were initiated but not ordered by the physician for 1 of 1 Patient (Patient #3) who was physically restrained and whose record was reviewed. This caused Patient #3 to have an excessive number of physical restraints placed on her by security officers due to lack of physician involvement and approval of the restraint. Additionally, Patient #3 was put at risk of increased injury due to the excessive amount of restraints used. Findings include:

A facility policy titled, "Restraints and Seclusion," effective 5/17/20 stated, "Definitions ... Restraint: Any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely ... Physical Holding: The application of force to physically hold a patient, in order to administer a medication against the patient's wishes is considered a restraint." It also stated, "a physician/LIP order, from the practitioner responsible for the care of the patient, is required for the application of any restraint."

Security reports of all interactions with Patient #3 throughout her stay in the ED were requested. The following physical restraints were used on Patient #3 without involvement of a physician:

1. Security restrained Patient #3 once on 7/29/23:

A security incident by Staff C from 7/29/23 was reviewed and stated, "SO [Name], [name], and I entered her room and calmly explained to her that if she did not willingly take her medication it would be administered to her through a shot. [Patient #3 name] was yelling at us that she refused to take it and that she could 'not take it with water' after several minutes of back and forth dialogue, nurse [name], decided to give the shot. SO [name] used open hand control on her right arm, and I used open hand control on her left arm. Nurse [name] administered the medication in her right upper arm."

Additionally, a physician note from 8/12/23 stated, "As pt is own guardian, can legally refuse non emergency medications ... ok to reoffer medications several times."

2. Security restrained Patient #3 three times on 8/11/23:

Staff I's account of the incident included two restraints: "At this time [Patient #3] walked towards me and attempted to push past me, at which point I grabbed her left arm and [Patient #3] used her bodyweight to fall to the floor. SO [Staff J] got hold of her right arm, after a short moment we decided to try reasoning with her again," and "[Patient #3] was wheeled back to 15 with her arms held to the side of the wheelchair."

Staff J's account of the incident included one restraint: "SO [Staff I name] and E.D. Tech [Staff H name] held her to her bed until she stopped thrashing around."

The ED Manager, Staff A, was interviewed on 8/28/23 at 1:31 PM and Patient #3's security incidents were reviewed with him and he was asked if the above incidents would be considered restraints. He said, "if the patient was held down, yes." He stated there was no restraint documentation in Patient #3's medical record, including notification to the physician that a restraint was used.

The facility failed to ensure the physician was consulted when the restraint was not ordered by the physician.

Based on record review, incident report review, facility policy review, and staff interview, it was determined the facility failed to ensure a patient was seen face to face by a physician or LIP within 1 hour of initiation of a violent restraint for 1 of 1 patient (Patient #3) who was manually restrained and whose record was reviewed. This caused Patient #3's psychological needs prior to restraint initiation to go unaddressed. Findings include:

A facility policy titled, "Restraints and Seclusions," effective 5/17/20 stated, "Patients who are restrained or secluded for the management of violent or self-destructive behaviors must be seen face-to-face within one (1) hour after the initiation of the intervention by a physician or licensed independent practitioner or by a registered nurse who has been trained to conduct face-to-face examinations. This evaluation must be documented in the patient's medical record." This policy was not followed. Examples include:

Patient #3 was a 40 year old female who was admitted to the ED on 7/17/23 and was in the ED for over a month. She had diagnoses including TBI, PTSD, depression, and a developmental delay.

Security reports of all interactions with Patient #3 throughout her stay in the ED were requested. The following physical restraints were used on Patient #3:

a. Security restrained Patient #3 once on 7/29/23:

A security incident by Staff C from 7/29/23 was reviewed and stated, "SO [Name], [name], and I entered her room and calmly explained to her that if she did not willingly take her medication it would be administered to her through a shot. [Patient #3 name] was yelling at us that she refused to take it and that she could 'not take it with water' after several minutes of back and forth dialogue, nurse [name], decided to give the shot. SO [name] used open hand control on her right arm, and I used open hand control on her left arm. Nurse [name] administered the medication in her right upper arm."

Additionally, a physician note from 8/12/23 stated, "As pt is own guardian, can legally refuse non emergency medications ... ok to reoffer medications several times."

b. Security restrained Patient #3 once, using a 4-point manual hold, on 8/10/23:

Staff C's report of the event stated, "[Staff D], [Staff B], and I were in the ED department posted because [Patient #3] had been acting aggressively and threw orange juice on her one to one. [Patient #3] had her television privileges revoked by staff for her poor behavior. At approximately 17:38 [Patient #3] came out of her room and hit the power button for her TV. ED Tech [Staff E name] stepped forward and told her no she could not watch TV. [Patient #3] grabbed the paper sack out of her garbage can and threw it at [Staff E] and then kicked the garbage can towards her. SO [Staff D name] stepped forward and used open hand control on her left arm and SO [Staff B name] stepped forward to use open hand control on her right arm ... she then lowered her head and bit SO [Staff B name] ... At this point I assisted SO [Staff D name] in taking her to the floor. Once [Patient #3 name] was on the floor I used open hand control on both her ankles while SO [Staff D name] maintained open hand control on her left arm and SO [Staff B name] maintained open hand control on her right arm. SO [Staff B name] asked [Staff E name] to request restraints from Dr. [Staff F name]. Several minutes later Dr. [Staff F name] came into the room and in a very condescending manner said 'Guys, don't treat her like that, just close the door and let her act out ... All three security officers then released [Patient #3 name] and stepped out of the room."

c. Security restrained Patient #3 three times on 8/11/23:

- Staff I's account of the incident included two restraints: "At this time [Patient #3] walked towards me and attempted to push past me, at which point I grabbed her left arm and [Patient #3] used her bodyweight to fall to the floor. SO [Staff J] got hold of her right arm, after a short moment we decided to try reasoning with her again," and "[Patient #3] was wheeled back to 15 with her arms held to the side of the wheelchair."

- Staff J's account of the incident included one restraint: "SO [Staff I name] and E.D. Tech [Staff H name] held her to her bed until she stopped thrashing around."

The ED Manager, Staff A, was interviewed on 8/28/23 at 1:31 PM and Patient #3's security restraints were reviewed with him and he was asked if the above incidents would be considered restraints. He said, "if the patient was held down, yes." He stated there was no restraint documentation in Patient #3's medical record, including a 1 hour face to face evaluation by physician or LIP.

The facility failed to ensure Patient #3 was assessed by a physician or LIP within one hour of restraint initiation.

Based on medical record review, policy review, incident report review, and staff interview, it was determined the facility failed to ensure least restrictive interventions were used to protect a patient from harm for 2 of 7 patients (Patients #3 and #1) whose records were reviewed. This created the potential for physical and emotional harm to Patient #3 and Patient #1. Findings include:

A facility policy titled, "Restraints and Seclusions," effective 5/17/20 stated, "Documentation ... the description of events leading to the use of restraints. Note the least restrictive measures attempted." Additionally, the policy stated, "The use of restraints or seclusion must ... not be used as punishment, for convenience, coercion, retaliation, in place of appropriate staffing or because of a history of dangerous behavior." This policy was not followed. Examples include:

1. Patient #3 was a 40 year old female who was admitted to the ED on 7/17/23 and was in the ED for over a month. She had diagnoses including TBI, PTSD, depression, and a developmental delay.

Security reports of all interactions with Patient #3 throughout her stay in the ED were requested. The following physical restraints were used on Patient #3:

a. Security restrained Patient #3 once on 7/29/23. There was no documentation of less restrictive interventions:

A security incident by Staff C from 7/29/23 was reviewed and stated, "SO [Name], [name], and I entered her room and calmly explained to her that if she did not willingly take her medication it would be administered to her through a shot. [Patient #3 name] was yelling at us that she refused to take it and that she could 'not take it with water' after several minutes of back and forth dialogue, nurse [name], decided to give the shot. SO [name] used open hand control on her right arm, and I used open hand control on her left arm. Nurse [name] administered the medication in her right upper arm."

Additionally, a physician note from 8/12/23 stated, "As pt is own guardian, can legally refuse non emergency medications ... ok to reoffer medications several times."

b. Security restrained Patient #3 once, using a 4-point manual hold, on 8/10/23. There was no documentation of less restrictive interventions:

Staff C's report of the event stated, "[Staff D], [Staff B], and I were in the ED department posted because [Patient #3] had been acting aggressively and threw orange juice on her one to one. [Patient #3] had her television privileges revoked by staff for her poor behavior. At approximately 17:38 [Patient #3] came out of her room and hit the power button for her TV. ED Tech [Staff E name] stepped forward and told her no she could not watch TV. [Patient #3] grabbed the paper sack out of her garbage can and threw it at [Staff E] and then kicked the garbage can towards her. SO [Staff D name] stepped forward and used open hand control on her left arm and SO [Staff B name] stepped forward to use open hand control on her right arm ... she then lowered her head and bit SO [Staff B name] ... At this point I assisted SO [Staff D name] in taking her to the floor. Once [Patient #3 name] was on the floor I used open hand control on both her ankles while SO [Staff D name] maintained open hand control on her left arm and SO [Staff B name] maintained open hand control on her right arm. SO [Staff B name] asked [Staff E name] to request restraints from Dr. [Staff F name]. Several minutes later Dr. [Staff F name] came into the room and in a very condescending manner said 'Guys, don't treat her like that, just close the door and let her act out ... All three security officers then released [Patient #3 name] and stepped out of the room."

c. Security restrained Patient #3 three times on 8/11/23. There was no documentation of less restrictive interventions:

- Staff I's account of the incident included two restraints: "At this time [Patient #3] walked towards me and attempted to push past me, at which point I grabbed her left arm and [Patient #3] used her bodyweight to fall to the floor. SO [Staff J] got hold of her right arm, after a short moment we decided to try reasoning with her again," and "[Patient #3] was wheeled back to 15 with her arms held to the side of the wheelchair."

- Staff J's account of the incident included one restraint: "SO [Staff I name] and E.D. Tech [Staff H name] held her to her bed until she stopped thrashing around."

Staff B was interviewed on 9/28/23 beginning at 10:00 AM and Patient #3's incidents with security were reviewed with him. When asked if holding a patient down was considered a restraint he stated, "yes, it is."

Staff I was interviewed on 9/28/23 at 10:55 AM and security restraints of Patient #3 were reviewed with him. When asked if he considered less restrictive interventions with Patient #3 before restraining her, such as just disengaging with her, he stated, "it would be purely circumstantial."

The ED Manager, Staff A, was interviewed on 8/28/23 at 1:31 PM and Patient #3's security incidents were reviewed with him and he was asked if the above incidents would be considered restraints. He said, "if the patient was held down, yes." He stated there was no restraint documentation in Patient #3's medical record, including a less restrictive interventions.

The facility failed to ensure less restrictive interventions were attempted and documented before restraining Patient #3.

2. Patient #1 was a 38 year old male who presented to the ED with his case manager and had been manic for a few days prior to his ED admission.

Patient #1's medical record included he attempted to elope and security was able to bring him back to the ED.

Patient #1 was then given the following medications:
7/11/23 5:03 PM Haldol 5 mg IM
7/11/23 5:03 PM Ativan 2 mg IM
7/11/23 5:03 PM Benadryl 50 mg IM

Patient #1's medical record included he was given Ketamine 500 MG IM on 7/12/23 at 12:43 AM. It included a note from the provider that Patient #1 "was fairly well controlled for several hours but then became agitated again and was given IM Zyprexa. After 2 hrs [hours] he was still agitated so was given IM Ketamine."

Patient #1's record included an RN note from 7/12/23 at 5:36 AM which included, "PT was still pacing the room, slamming doors whipping blankets, pushing buttons and punching walls. 500 mg of Ketamin [sic] given @ 0043. Pt fell asleep approx [sic] 20 min after administration. Pt slept until 0430 at that time were able to convince pt to let us acquire labs. He ate a sandwich and started repeating previous behaviors. Pt was again dosed with 500 mg of ketamine. Pt became drowsy but was still thrashing on the floor required someone with him to protect him. Pt was given Geodon @0515. Pt quickly went to sleep. Pt started having a seizure after the dose of Geodon. Vitals were taken, nasal airway inserted. [name] RN started an IV on pt. Plan is to administer Keppra and have access to continue giving medications pt is sleeping, O2 monitor on."

Patient #1's medical record included that he was given a second dose of Ketamine 500mg IM on 7/12/23 at 4:39 AM and a second dose of Geodon 40 mg IM on 7/12/23 at 5:15AM.

Patient #1's medical record included a note from the oncoming provider on 7/12/23 at 8:04 AM. It included:

"Patient became agitated again and was a danger to himself. He received a repeat dose of ketamine and Geodon. Patient then had a seizure witnessed by nursing staff which was resolved by the time I got to the room .... Patient was observed in the department and had another episode of convulsions. I decided at that time that patient need to be intubated to protect his airway as he was unable to do so ... Case discussed with [physician name] from intensivist service who will accept the patient for admission"

The medical record did not document attempts at or discussions of alternative measure to modify behavior before the usage of Ketamine and Geodon medications.

A hospital RN was interviewed on 9/26/23 beginning at 2:30 PM she confirmed there was no documentation of alternative measures to calm patient were attempted prior to Ketamine and Geodon dosages at 4:39 and 5:15 AM on 7/12/23.

The facility failed to ensure less restrictive interventions were attempted and documented before chemically restraining Patient #1.

Based on policy review, medical guidelines review, patient record review, incident report review, and staff interview, it was determined the facility failed to ensure medications were administered in accordance with accepted standards of practice and facility policy for 1 of 7 patients (Patient #7) whose records were reviewed. This resulted in the facility's failure to meet the emergency needs of the patient and put the patient at risk of serious injury, serious impairment, or death. This had the ability to affect all patients presenting to the ED for emergency services. Findings include:

A facility policy titled, "Medication Administration" stated, "Staff members/providers are not to administer medications without prior knowledge of the patient, allergies, medication actions, emergency treatment related to the administration of the medication, and method of administration."

A facility policy titled, "ED Stroke Alert" stated, "Thrombolytic administration and monitoring. Monitor & document blood pressure and neuro [neurological] status at least every 15 minutes during the 1-hour infusion and every 15 minutes for one hour after. Then Q 30 mins [every 30 minutes] for the next 6 hours. Hourly from the 8th post infusion hour until 24 hours after infusion. Prior to and upon administration of thrombolytics, the blood pressure must be maintained below 180/105 mm Hg [millimeters of mercury]. Notify the provider immediately for blood pressures greater than defined to obtain an order for antihypertensive medication."

The above policies were not followed. An example includes:

1. Tenecteplase [TNK] is a thrombolytic agent which means it can dissolve blood clots. It is used to treat stroke.

Institute For Safe Medication Practices website was accessed 9/27/23. It listed TNK as a high alert medication which meant, "drugs that bear a heightened risk of causing significant patient harm when they are used in error. "

The National Library of Medicine website was accessed 9/27/23. It stated, "Bleeding is the most common complication of tenecteplase and thrombolytic use. Bleeding can occur anywhere in the body, as well as at puncture and surgical sites. Intracranial hemorrhage poses the most significant concern for increased mortality." The website also included, "Severe uncontrolled hypertension" as a contraindication for the use of tenecteplase. Additionally it stated, "A neurological exam must be serially performed to assess for deterioration in mental status or any new focal neurological deficits, which may suggest a bleeding event."

Patient #7 was an 83 year old female who arrived in the ED via EMS on 7/27/23 with shortness of breath and a blood pressure of 237/90.

Patient #7's medical record was reviewed. It included that she was given TNK at 7:20 PM on 7/27/23. Patient #7's last documented vital signs prior to administration of TNK included a blood pressure of 216/102 at 6:55 PM. There was no documentation in Patient #7's medical record that her vital signs were reviewed prior to the administration of TNK. There was no documentation Patient #7's presenting symptom, shortness of breath, was reviewed which would show TNK was not indicated. Additionally, there was no documentation a provider was notified of Patient #7's elevated blood pressure.

Patient #7's medical record included a physician note dated 7/27/23 at 7:42 PM and stated, "the patient was unintentionally given TNK."

Patient #7's medical record did not contain documentation that clinically indicated the need for TNK.

The facility incident report of Patient #7 dated 7/28/23 was reviewed. The incident report completed by the RN stated, "After administered I looked into the pts chart and realized right away that this was ordered on the wrong pt."

The ED Manager, Staff A, was interviewed on 9/27/23 beginning at 9:20 AM. He confirmed that Patient #7 got the full dose of TNK mistakenly, and based on Patient #7's high blood pressure and lack of stroke symptoms, this medication was contraindicated.

Patient #7's RN who administered the TNK was interviewed on 9/27/23 beginning at 3:25 PM. The RN was asked about the contraindications to administering TNK. The RN stated, "Eliquis." The RN confirmed she did not review Patient #7's chart prior to administration of TNK. Additionally, the RN was asked if she had any training on TNK policies and procedures after the incident. She said she had not received training from facility leadership.

The facility staff failed to follow accepted standards of practice and established policy and procedures in the administration of a high alert, high risk medication. This resulted in Patient #7 receiving a thrombolytic medication in error and had the potential for a significant negative outcome.

2. A facility policy titled, "ED Stroke Alert" stated, "Thrombolytic administration and monitoring. Monitor & document blood pressure and neuro status at least every 15 minutes during the 1-hour infusion and every 15 minutes for one hour after." This policy was not followed.

Patient #7's medical record was reviewed on 9/27/23 and had documented neurological checks done on 7/27/23 at 7:41 PM, 8:34 PM, and 9:30 PM. TNK was administered at 7:20 PM by an RN. According to facility policy, Patient #7 should have had a total of 8 neurological checks after the administration of TNK. However, Patient #7 had 3 random neurological checks in a two-hour period.

The ED Manager, Staff A, who was an RN was interviewed on 9/27/23 beginning at 9:20 AM about the frequency of Patient #7's neurological checks. He confirmed Patient 7 should have had neurological checks every 15 minutes for the first 2 hours per TNK protocol.

The facility failed to ensure staff followed policies and procedures in assessing neurological checks on Patient #7 after receiving a thrombolytic.

3. The Medical Director, Pharmacist Manager, Stroke Team Coordinator, and the VP of Quality Management were interviewed on 9/27/23 beginning at 11:00 AM. They were asked about the above medication error with Patient #7 and what steps were put in place to prevent another incident. They confirmed that they had a meeting with the pharmacy and stroke team. They confirmed they did not include the ED Providers, who ordered the medication on the incorrect patient, or nursing staff, who administered the medication on the wrong patient, in the meeting.

The VP of Quality was interviewed on 9/28/23 beginning at 9:20 AM. He was asked if the ED Providers and Nursing staff had retraining on the policy and procedure for TNK administration. He stated, "we have not."

The facility failed to retrain all staff involved in the policies and procedures of administration of a thrombolytic.

The cumulative effect of the negative systemic practice had the ability to affect all patients presenting to the ED for emergency treatment.