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Based on the scope and severity of the deficiencies related to Patient Rights, the facility failed to substantially comply with this condition.

Please see the following tags:

A-0154 - Based on video review, interviews, and document review, it was determined the facility staff failed to ensure that Patient #2 maintained the right to be free from seclusion imposed by the staff for convenience.

A-0162 - Based on video reviews, interviews, and document review, it was determined the staff physically prevented Patient #2 from leaving a room with a locked cart and a locked stretcher and the staff were unaware that this practice was seclusion. Patient #2 was not exhibiting violent or self-destructive behavior and the staff did not have an order for seclusion or any training or education on seclusion.

A-0168 - Based on interview and document review, it was determined the facility staff failed to apply a restraint in accordance with the order of an authorized provider for one (1) of three (3) patients with restraints (Patient #6).

A-0178 - Based on interview and document review, it was determined the facility staff failed to conduct a one (1)-hour face-to-face evaluation for one (1) of three (3) patients with restraints (Patient #5).

A-0194 - Based on interviews, and document review, it was determined the facility failed ensure staff were trained on the safe implementation of seclusion.

An Immediate jeopardy (IJ) was called on 3/29/2022 at 3:05 p.m. related to tags A-0154 and A-0194 and abated on March 30, 2022 at 2:38 p.m.

The steps the facility took to abate the immediate jeopardy were as follows:

1. On 3/29/2022 Electronic Education Module (Workday system) "Restraints: Legal Considerations and Patient Rights" was assigned to all Emergency Department (ED) staff for completion. The module includes content regarding seclusion expectations. Scheduled staff will complete the module prior to working their next shift beginning the evening of 3/29/2022. This will continue over the course of the next week until all scheduled staff are compliant. Staff unable to complete the module prior to this deadline due to vacation or leave of absences, for example, will complete the module prior to their next shift.

2. 3/29/2022 All ED staff were educated during huddles and 1:1 education each shift to expectations for seclusion to include, but not limited to: applicability, orders, monitoring, safety procedures, and what is seclusion (definition & examples). Evidence of this was captured via a signed attestation statement. These began the evening of 3/29/2022, continuing each shift, and the organization expects to reach all ED staff by 4/8/2022.

3. 3/29/2022 All ED providers were educated via a memo from the Vice President of Medical Affairs (VPMA) regarding the expectations for seclusion to include but not limited to applicability, orders, monitoring, safety procedures, and what is seclusion (definition & examples). Evidence of this was captured via a signed attestation statement. These began the evening of 3/29/2022, this will continue over the course of the next week until all scheduled providers are compliant. Providers unable to complete the module prior to this deadline due to vacation or leave of absence, for example, will complete the module prior to their next scheduled shift. Additionally, the VPMA will present this content at the Medical Executive Committee (MEC) meeting on 4/11/2022.

4. 3/29/2022 The Bon Secours Mercy Health (BSMH) policy "Physical Restraint - Use of Restraint for Violent, Self-Destructive Patient Situations" was revised with a multi-disciplinary group to include seclusion-specific content for Assessment, Justification, Alternatives, Orders, Initiation, Monitoring, Documentation, Definition, and examples. The content added was in alignment with CMS CoPs, facility EMR capabilities, and education. Further the title of the document was revised to "Physical Restraint or Seclusion - Use of Restraint for Violent, Self-Destructive Patient Situations" to include seclusion and improve accessibility of the document for staff. This draft was completed on 3/29/2022 and offered for approval to the ministry on 3/30/2022.

The surveyors confirmed the corrective actions were complete or implemented by reviewing a printout of the Electronic Education Module "Restraints: Legal Considerations and Patient Rights" training/education and determined it contained appropriate information to educate the staff on seclusion expectations. The surveyors reviewed seclusion related attestations signed by the staff. On 3/30/2022 there were forty-five (45) emergency department employee signed attestations and five (5) affiliate provider signed attestations. The surveyors reviewed the revised "Physical Restraint or Seclusion - Use of Restraints for Violent, Self-Destructive Patient Situations" policy draft and determined it contained content aligned with the CMS CoPs.

Based on video review, interviews, and document review, it was determined the facility staff failed to ensure that Patient #2 maintained the right to be free from seclusion imposed by the staff for convenience.

The findings include:

On 3/28/2022 at 12:32 p.m., the surveyors reviewed video of the Emergency Department hallway in front of room twelve (12) from 10:50 a.m. through 12:55 p.m on 3/1/2022. There was no sound recorded on the video. Staff Member #4 (Director of Emergency Services) navigated the surveyors through the video explaining who staff were, what the patient was saying, and what certain items were in the video.

The video revealed that SM #12 (Nurse) placed a personal protective equipment (PPE) cart in front of the doorway to Patient #2's room twelve (12) at 11:00 a.m. and locked the wheels on the cart.

At 11:05 a.m. Patient #2 moved the cart and exited the room. After the patient returned to the room, SM #8 (Unit Secretary) placed the PPE cart back in front of Patient #2's doorway and locked the wheels to the cart.

At 11:13 a.m. a nurse moved the cart and let Patient #2 out of the room and walked the patient around the corner (according to SM #4 staff were walking the patient to the bathroom). After Patient #2 returned to room twelve (12) from the bathroom, SM #8 placed the PPE cart back in front of Patient #2's doorway and locked the wheels.

At 11:20 a.m. Patient #2 is observed leaning forearms on the cart in the doorway to the patient's room.

At 11:24 Patient #2 moved the PPE cart and exited the room to go to the bathroom. At 11:27 a.m. Patient #2 returned to the room and the cart was returned to block the doorway to the patient's room.

At 11:29 a.m. SM #4 (Director of Emergency Services) moved the cart and entered the room with the patient. When SM #4 left the room, SM #8 returned the cart back to the patient's doorway and locked the wheels.

At 11:46 a.m. Patient #2 moved the cart and exited the room. When the patient returned to the room the cart was put back in the doorway and another cart was put in front of the first cart in the doorway for a few moments and then the second cart was moved.

At 11:51 a.m. Patient #2 was assisted to the bathroom and then returned to the room and the wound care cart was placed in the patient's doorway and the wheels locked.

At 11:53 a.m. SM #12 (Nurse) placed a stretcher in front of the cart that was in the patient's doorway and locked the wheels to the stretcher.

After the locked stretcher was placed in front of the locked wound care cart in the patient's doorway, the patient was not able to exit the room by moving the stretcher and cart.

At 12:26 p.m. the stretcher and cart were moved from Patient #2's doorway so that SM #13 could enter the patient's room to complete a behavioral health evaluation. The cart was placed in the doorway while SM #13 was in the room with the patient.

At 12:29 p.m. after SM #13 left the room, the wound care cart was placed back in the patient's doorway and the wheels were locked and the stretcher was placed in front of the wound care cart and the wheels were locked.

At 12:44 p.m. SM #8 moved the stretcher and cart and entered the patient's room. After SM #8 left the room, a cart was placed back in the patient's doorway and the wheels locked.

At 12:52 p.m. the cart was moved away from Patient #2's doorway.

At 12:55 p.m. a staff member placed a chair in room twelve (12) with Patient #2 and another staff member entered the room to be the sitter for the patient (as per SM #4).

During an interview on 3/29/2022 at 9:39 a.m., SM # 8 (Unit Secretary) stated that the staff had a hard time keeping Patient #2 in the room. SM #8 stated SM #8 helped the staff by getting the patient what the patient was requesting, like a toothpick from the cafeteria and warming up the patient's food. SM #8 stated that Patient #2 had "more requests when something was blocking the door". SM #8 stated that SM #8 had not seen a patient blocked in a room before. SM #8 stated that blocking a patient in a room was "not the safest thing to do". SM #8 stated that they had requested a sitter to be in the room with the patient but that request had been denied.

During an interview on 3/29/2022 at 10:00 a.m., SM #9 (Nurse) stated that on the morning of 3/1/2022 SM #9 was assigned as Patient #2's nurse and that Patient #2 was talking loudly at the nurses station about something being stuck in the patient's tooth. SM #9 had been caring for other patients and when SM #9 went past Patient #2's room, there was an isolation cart in front of the patient's door. SM #9 stated, "I thought it probably shouldn't be there but it was there to keep [patient] from wondering around. It was preventing [patient] from coming out. [Patient] was able to walk freely in the room." SM #9 stated that SM #9 had not seen a patient blocked in their room previously. SM #9 recalled coming back to the room later and there were two carts in front of Patient #2's door and later after SM #9's lunch there was a cart and a stretcher blocking the doorway to Patient #2's room. SM #9 stated "I guess [the patient] had gotten through it [the cart]." SM #9 stated there was no order for restraints or seclusion for this patient. SM #9 was not sure about what was required for "restraining a patient in the room." and they did not have a sitter available to be with the patient at the time. SM #9 stated "I don't recall talking about seclusion during training" and restraints are only used as a last resort. SM #9 stated that another staff member had walked Patient #2 to the bathroom and then immediately after returning from the bathroom SM #9 heard the patient saying that the patient couldn't get out. SM #9 stated that once they were able to get a sitter for Patient #2 the stretcher and carts were removed. SM #9 stated that someone had asked why the stretcher was blocking Patient #2's door and SM #9 stated "Well I think it's here to prevent [the patient] from coming out of the room and for [the patient's] safety." SM #9 stated the stretcher was blocking the hallway too. SM #9 stated that SM #9 is a newer nurse and in regards to blocking a patient in a room, "I didn't know we couldn't do it." SM #9 stated there was no training about seclusion stating that they couldn't put a cart in front of the door to prevent the patient from coming out of the room.

During an interview on 3/29/2022 at 10:20 a.m., SM #4 stated that SM #4 was in the emergency department on the morning of 3/1/2022 and heard Patient #2 yelling. SM #4 asked the staff if the patient was being cared for and they were. SM #4 saw the cart was blocking Patient #2's doorway and thought that "it shouldn't be there." SM #4 went into the room with the patient to clear the clutter in the room for the patient's safety, but the patient became more agitated the longer SM #4 was in the room. SM #4 stated that blocking the doorway was a "temporary means to an end. Hindsight is 20/20 and in the moment they were doing the best they could. You know it's not an optimal intervention." SM #4 stated that SM #4 has never seen carts blocking a patient's door in the past as an intervention for dementia or confusion.

During an interview on 3/29/2022 at 11:21 a.m., SM #12 stated that the night shift nurse had reported that Patient #2 was "very active all night" and SM #12 "felt like I needed to keep the patient safe. I came up with the 'baby gate' to keep [the patient] contained and safe and then went back to triage." SM #12 stated that the other option was to restrain the patient and SM #12 stated that SM #12 did not like restraining. SM #12 stated that SM #12 did not receive seclusion training.

During an interview on 3/29/2022 at 12:08 p.m., SM #13 stated that when SM #13 arrived to do a behavioral health evaluation on Patient #2, there was a "crash cart" in the patient's door way and when SM #13 left, the nurse moved "another object" in front of the door along with the "crash cart".

A review of the facility's policy titled "Patient Rights and Responsibilities," states in part:
...3. You have the right to receive care in a safe setting that is reasonable and appropriate to your needs and preserves dignity.
...17. Patients have the right to be free from restraints and seclusion not medically necessary or used as a means of coercion, discipline, convenience, or retaliation by staff...

Based on video review, interviews, and document review, it was determined the staff physically prevented Patient #2 from leaving a room with a locked cart and a locked stretcher and the staff were unaware that this practice was seclusion. Patient #2 was not exhibiting violent or self-destructive behavior and the staff did not have an order for seclusion or any training or education on seclusion.

The findings include:

See related tag A-0154

A review of the medical record for Patient #2 evidenced that there was no order for seclusion or restraint for this patient. There was no documentation in the medical record that the patient was exhibiting violent or self-destructive behavior. Patient #2 was discharged home from the emergency department on 3/1/2022 at 6:10 p.m.

A review of the Psychiatry Consult Note from 3/1/2022 at 6:10 p.m. contained evidence that Patient #2 did not meet acute inpatient psychiatric criteria and could be discharged home when medically stable. There was no documentation in the Psychiatry Consult Note that the patient was exhibiting violent or self-destructive behavior.

A review of the facility's policy titled "Patient Rights and Responsibilities," states in part:
...3. You have the right to receive care in a safe setting that is reasonable and appropriate to your needs and preserves dignity.
...17. Patients have the right to be free from restraints and seclusion not medically necessary or used as a means of coercion, discipline, convenience, or retaliation by staff...

Based on interview and document review, it was determined the facility staff failed to apply a restraint in accordance with the order of an authorized provider for one (1) of three (3) patients with restraints (Patient #6).

The findings include:

On 03/30/22 at 3:02 p.m., Staff Member #20 (Clinical Nurse Specialist) assisted the surveyor in navigating through the electronic medical record (EMR) of Patient #6.

According to the History and Physical (H&P) documentation, dated on 02/04/22, Patient #6 presented to the ED for lethargy, dizziness, and altered mental status, and later admitted to the telemetry unit.

The surveyor reviewed the inpatient orders, which revealed that Patient #6 was ordered bilateral mitt restraints for the management of non-violent behavior, including the "interference" of medical equipment and treatment.

The order revealed that the authorized provider ordered the restraints for the times of 10:15 p.m. on 02/06/22 until 11:59 p.m. on 02/07/22.

A review of the restraint flow sheet documentation revealed that the Registered Nurse applied the bilateral mitt restraints to Patient #6 on 8:00 p.m. on 02/06/22. The surveyor confirmed with Staff Member #20 that the EMR reflected a period of greater than two (2) hours in which Patient #6 had restraints applied without an order.

The surveyor acquired the facility policy titled, "Use of Restraints for Nonviolent, Non-Self-Destructive Patient Situations: Medical Use of Restraints" (with last effective date of 11/19/21) in the afternoon of 03/28/22.

On the second page of policy, under "Initiation" section, the policy reads, "If the [Registered Nurse] initiates the restraint, an order must be obtained from the physician/provider or LIP as soon as possible but no later than within 12 hours".

Patient #6 experienced the use of restraints for over two (2) hours prior to a practitioner's restraint order. This length of time, and up to twelve (12) hours as outlined by facility policy, does not meet the regulation because it fails to allow the practitioner who is responsible for care of the patient to provide a timely review of the appropriateness of the restraint and the restraint method used.

Based on interview and document review, it was determined the facility staff failed to conduct a one (1)-hour face-to-face evaluation for one (1) of three (3) patients with restraints (Patient #5).

The findings include:

On 03/30/22 at 1:40 p.m., Staff Member #20 (Clinical Nurse Specialist) assisted the surveyor in navigating through the electronic medical record (EMR) of Patient #5.

According to the History and Physical (H&P) documentation, dated on 02/04/22, Patient #5 was a young adult brought into the facility Emergency Department (ED) via local law enforcement with a temporary detention order (TDO) for suicidal threats. Patient #5 was then admitted to the inpatient behavioral health unit (BHU).

Under "History of Presenting Complaint", the H&P reads, "As soon as [Patient #5] arrived here at BHU, [Patient #5] was verbally threatening, aggressive, posturing, using profanities. [Patient #5] was then put on four-point restraints. [Patient #5] was also given Haldol Benadryl Ativan injections. [Patient #5] is admitted to the inpatient psychiatric setting for further stabilization and treatment".

The surveyor requested Staff Member #20 to reveal the orders associated with Patient #5's inpatient encounter. The order set information revealed that Patient #5 was ordered hard four-point leather restraints for the management of adult violent or self-destructive behavior. The violent restraint order for Patient #5 was active from 7:00 am to 10:59 a.m. on 02/04/22.

A review of the restraint flow sheet documentation revealed that the violent restraint was discontinued on 02/04/22 at 9:20 a.m.

The surveyor acquired the facility policy titled, "Physical Restraint-Use of Restraints for Violent, Self-Destructive Patient Situations" (with last effective date of 04/21/21) in the afternoon of 03/28/22.

On the second page of policy, under "Restraint Order (to manage violent or self-destructive behavior)" section, the policy reads, "The 1-hour face-to-face patient evaluation must be conducted in person by a physician or other LIP [licensed independent provider], or trained RN or PA. A telephone call or telemedicine methodology is not permitted".

The surveyor was unable to find an applicable face-to-face evaluation of Patient #5, and requested the additional assistance of the Staff Member #20. Following additional attempts by Staff Member #20, the surveyor was informed they were unable to locate such documentation.

The surveyor forwarded the concern to Staff Member #2 (Quality Improvement personnel) who further attempted in locating the documentation. On 03/30/22 at 3:28 p.m., Staff Member #2 confirmed with surveyor they were unable to locate the one-hour face-to-face evaluation of Patient #5.

Based on interviews, and document review, it was determined the facility failed to ensure staff were trained on the safe implementation of seclusion.

The findings include:

During an interview on 3/29/2022, SM #3 (Assistant Chief Nursing Officer) stated that the facility did not train and educate their staff on seclusion because they did not use seclusion in the facility and did not want to encourage the use of seclusion.

During an interview on 3/29/2022 at 9:25 a.m., SM #7 stated that as a case manager SM #7 receives training on restraints. SM #7 stated that they "did not think it was right to block a patient's doorway" and it is not a valid intervention. SM #7 stated that valid interventions would be to use a sitter or distraction.

During an interview on 3/29/2022 at 9:39 a.m., SM # 8 (Unit Secretary) stated that they took a class on restraint and seclusion that was a module on the computer and then met with a staff member to review how to apply restraints. SM #8 couldn't remember anything about seclusion training and what it included.

During an interview on 3/29/2022 at 10:00 a.m., SM #9 stated that SM #9 is a newer nurse and in regards to blocking a patient in a room, "I didn't know we couldn't do it." SM #9 stated there was no training about seclusion stating that they couldn't put a cart in front of the door to prevent the patient from coming out of the room. SM #9 stated that SM #9 learned from restraint training that there needs to be an order by the doctor to apply restraints and the order needs to be renewed every twenty-four (24) hours for non-violent restraints. SM #9 stated that soft restraints require patient checks every two (2) hours. SM #9 stated that SM #9 was not exactly sure about restraining a patient in the room. SM #9 stated, "I don't recall talking about seclusion during training."

During an interview on 3/29/2022 at 11:20 a.m., SM #3 stated that the facility does not teach their nurses about seclusion and there is no competency for them to complete, they only teach about restraints.

During an interview on 3/29/2022 at 11:01 a.m., SM #10 (Patient Care Tech - PCT) stated that SM #10 does not recall if they had restraint training.

During an interview on 3/29/2022 at 11:21 a.m., SM #12 stated that SM #12 did not receive seclusion training.

During an interview on 3/29/2022 at 10:20 a.m., SM #4 stated that they educated the "entire team" and told them "we can't do this". SM #4 stated that quality and safety did a "comprehensive review". SM #4 stated that SM #5 (Nurse Director) had notified the staff that the stretcher and cart blocking Patient #2's door was a "bad idea" then removed the cart and stretcher and also notified SM #4.

During an interview on 3/29/2022 at 3:30 p.m., SM #4 stated that the facility was working on reeducating the staff regarding the incident of blocking Patient #2 in a room with a cart and stretcher. SM #4 stated that the wording they were using in the education was restraints and not seclusion.

During an interview on 3/30/2022 at 11:55 a.m., SM #1 stated that leadership "understood early on that the staff didn't know that they couldn't put a cart in front of a patient's room." SM #1 stated that leadership's focus was that the staff needed a sitter for the patient instead of using a cart.

The facility was unable to provide any documentation of the reeducation provided to staff, the plan for reeducation to staff, or the analysis and draft action plan following the incident with Patient #2. SM #2 stated that the facility was waiting for the results of the Adult Protective Services (APS) investigation before completing the facility's action plan. Further, as per SM #2 and SM #3 (Assistant Chief Nursing Officer) the facility does not do seclusion.

A review of the document "New Employee Orientation 2022 - Annual Restraint Competency Review" contained the documentation "Participant will be able to: Verbalize strategies to identify staff and patient behaviors, events and environmental factors that may trigger circumstances that may require the use of restraint/seclusion. (RN participants only). The document contained no other evidence of training or education regarding seclusion.

A review of the document "2021 SMH Critical Care Competency Assessment Form & Education" contained the documentation "Note: This is a review of the technical competencies necessary for safe clinical practice. This supplements other continuing education, staff development programs, and PI monitoring programs" and includes in part a section on Restraints but does not include any competency related to seclusion.

The facility was unable to provide any other training, education, or transcripts of training and education regarding seclusion.

A review of the facility's policy titled, "Physical Restraint - Use of Restraints for Violent, Self-Destructive Patient Situations," effective 4/21/2021 states in part only the following documentation regarding seclusion:
...X. Definition of Terms:
...Seclusion: The involuntary confinement of a person alone in a room where the person is physically prevented from leaving by a barrier (locked door, sitter, etc.). This is less restrictive than restraints. NOTE: Seclusion is not just confining a patient to an area, but involuntarily confining the patient alone in a room or area where the patient is physically prevented from leaving. If a patient is restricted to a room alone and staff are physically intervening to prevent the patient from leaving the room or giving the perception that threatens the patient with physical intervention if the patient attempts to leave the room, the room is considered locked, whether the door is actually locked or not. In this situation, the patient is being secluded.

A review of the facility's policy titled, "Physical Restraint - Use of Restraints for Nonviolent, Non-Self-Destructive Patient Situations: Medical Use of Restraints," effective 11/19/2021 states in part only the following documentation regarding seclusion:
...X. Definition of Terms:
...Seclusion: The involuntary confinement of a person alone in a room where the person is physically prevented from leaving.

The facility's policies contained a only definition of seclusion but no other guidance as per the regulations.

Based on the scope and severity of deficiencies related to Quality Assessment and Performance Improvement (QAPI), the facility failed to substantially comply with this condition.

See related tags:

A-0273 - Based on interview and document review, it was determined the facility's Quality Assessment and Performance Improvement (QAPI) program failed to identify gaps in facility policy related to seclusion and failed to identify the need for staff training related to seclusion.

A-0283 - Based on interview and document review, it was determined the facility failed to take actions aimed at performance improvement and failed to measure success and track performance related to the use of seclusion.

A-0286 - Based on interview and document review, it was determined the facility failed to measure, analyze, and track adverse patient events related to seclusion.

Based on interview and document review, it was determined the facility's Quality Assessment and Performance Improvement (QAPI) program failed to identify gaps in facility policy related to seclusion and failed to identify the need for staff training related to seclusion.

The findings include:

See related tag A-0154

On 03/28/22 at 12:32 p.m., the surveyors reviewed video footage from the ED on 03/01/22, which showed Patient #2 being involuntarily confined in room twelve (12) via an isolation cart and hospital bed. A medical record review of Patient #2's EMR on 3/30/2022 at 1:00 p.m. confirmed there was no order for seclusion.

A review of facility policy titled, "Physical Restraint - Use of Restraints for Violent, Self-Destructive Patient Situations" (with last revision date of 4/21/2022) revealed there was no literature regulating the use, precautions, and procedures of seclusion interventions.

A review of personnel records, which occurred on 3/29/2022, revealed staff documented training for restraints only, including initial onboarding orientation and ongoing competency training. There was not training or competency for seclusion.

During an interview on 3/29/2022, SM #3 (Assistant Chief Nursing Officer) stated that the facility did not train and educate their staff on seclusion because they did not use seclusion in the facility and did not want to encourage the use of seclusion.

During an interview on 3/29/2022 at 11:20 a.m., SM #3 stated that the facility does not teach their nurses about seclusion and there is no competency for them to complete, they only teach about restraints.

A review of the document "New Employee Orientation 2022 - Annual Restraint Competency Review" contained the documentation "Participant will be able to: Verbalize strategies to identify staff and patient behaviors, events and environmental factors that may trigger circumstances that may require the use of restraint/seclusion. (RN participants only). The document contained no other evidence of training or education regarding seclusion.

A review of the document "2021 SMH Critical Care Competency Assessment Form & Education" contained the documentation "Note: This is a review of the technical competencies necessary for safe clinical practice. This supplements other continuing education, staff development programs, and PI monitoring programs" and includes in part a section on Restraints but does not include any competency related to seclusion.

The facility was unable to provide any other training, education, or transcripts of training and education regarding seclusion.

Based on interview and document review, it was determined the facility failed to take actions aimed at performance improvement and failed to measure success and track performance related to the use of seclusion.

The findings include:

See related tag A-0154

On 03/28/22 at 12:32 p.m., the surveyors reviewed video footage from the ED on 03/01/22, which showed Patient #2 being involuntarily confined in room twelve (12) via an isolation cart and hospital bed. A medical record review of Patient #2's EMR on 3/30/2022 at 1:00 p.m. confirmed there was no order for seclusion.

During an interview on 3/29/2022 at 3:30 p.m., SM #4 (Director of Emergency Services) stated that the facility was working on reeducating the staff regarding the incident of blocking Patient #2 in a room with a cart and stretcher. SM #4 stated that the wording they were using in the education was restraints and not seclusion.

During an interview on 3/30/2022 at 11:55 a.m., SM #1 (Direct of Quality) stated that leadership "understood early on [after the incident with Patient #2] that the staff didn't know that they couldn't put a cart in front of a patient's room." SM #1 stated that their focus was that they needed a sitter for the patient instead of using a cart. SM #1 confirmed that seclusion was not incorporated into the facility QAPI program.

The facility was unable to provide any documentation of the reeducation provided to staff, the plan for reeducation to staff, or the analysis and draft action plan following the incident of seclusion with Patient #2. SM #2 stated that the facility was waiting for the results of the Adult Protective Services (APS) investigation before completing the facility's action plan.

The facility was unable to provide any other training, education, or transcripts of training and education regarding seclusion.

Based on interview and document review, it was determined the facility failed to measure, analyze, and track adverse patient events related to seclusion.

The findings include:

See related tag A-0154

On 03/28/22 at 12:32 p.m., the surveyors reviewed video footage from the ED on 03/01/22, which showed Patient #2 being involuntarily confined in room twelve (12) via an isolation cart and hospital bed. A medical record review of Patient #2's EMR on 3/30/2022 at 1:00 p.m. confirmed there was no order for seclusion.

A review of the facility's adverse event log contained no evidence of seclusion related concerns or listed this event.

During an interview on 3/30/2022 at 11:55 a.m., SM #1 (Direct of Quality) stated that leadership "understood early on [after the incident with Patient #2] that the staff didn't know that they couldn't put a cart in front of a patient's room." SM #1 stated that their focus was that they needed a sitter for the patient instead of using a cart. SM #1 confirmed that seclusion was not incorporated into the facility QAPI program.

The facility was unable to provide any documentation of the reeducation provided to staff, the plan for reeducation to staff, or the analysis and draft action plan following the incident of seclusion with Patient #2. SM #2 stated that the facility was waiting for the results of the Adult Protective Services (APS) investigation before completing the facility's action plan.

Based on the scope and severity of the deficiency related to COVID-19 Vaccination of Facility Staff, the facility failed to substantially comply with this condition.

Please see the following tag:

A-0792 - COVID-19 Vaccination of Facility Staff

Based on interview and document review, it was determined the facility failed to:

meet the standard of the regulation of having contract staff provide evidence of vaccination status by the deadline. The facility failed to ensure COVID vaccination status was known for one-hundred sixteen (116) out of one-thousand three hundred sixty three (1363) affiliate providers;

provide completed medical exemption forms for one (1) of one (1) affiliate provider reviewed for medical exemption.

Additionally, the facility's policy failed to:

ensure the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19;

delineate a process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by CDC;

delineate a process for tracking and securely documenting information provided by those staff who have requested, and for who the hospital has granted, an exemption from the staff COVID-19 vaccination requirements;

delineate a process for ensuring the tracking and secure documentation of the vaccination status of staff for who COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and

delineate and enforce a contingency plan based on the CMS's COVID-19 vaccination deadlines.

Based on interview and document review, it was determined the facility failed to:

meet the standard of the regulation of having contract staff provide evidence of vaccination status by the deadline. The facility failed to ensure COVID vaccination status was known for one-hundred sixteen (116) out of one-thousand three hundred sixty three (1363) affiliate providers;

provide completed medical exemption forms for one (1) of one (1) affiliate provider reviewed for medical exemption.

Additionally, the facility's policy failed to:

ensure the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19;

delineate a process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by CDC;

delineate a process for tracking and securely documenting information provided by those staff who have requested, and for who the hospital has granted, an exemption from the staff COVID-19 vaccination requirements;

delineate a process for ensuring the tracking and secure documentation of the vaccination status of staff for who COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and

delineate and enforce a contingency plan based on the CMS's COVID-19 vaccination deadlines.

The findings include:

On 3/28/2022, Staff Member (SM) #6 (Chief Medical Officer) stated that SM #6 was responsible for tracking COVID vaccination status for the facility's contracted affiliate providers. SM #6 stated that SM #6 maintains a spreadsheet of the affiliate providers who have outstanding documentation of COVID vaccination compliance. SM #6 stated that their internal deadline for compliance for these providers is 4/23/2022.

On 3/29/2022, SM # 2 provided documentation received from SM #6 documenting that there were "one-hundred sixteen (116) missing cards out of one-thousand three hundred sixty three (1363) at this time among all of the [facility's] affiliate (non-employed and non-telemedicine) providers. Currently outstanding = 8.5%."

The facility was unable to provide medical exemption forms for one (1) of one (1) affiliate providers reviewed for medical exemption. During an interview on 3/30/2022 at 2:35 p.m., SM #2 stated that the affiliate providers are maintaining their own documentation and the facility is unable to provide medical exemption forms for any of their affiliate providers. SM #2 stated that Associate Health is not maintaining documentation of those exemption forms, although the facility's policy titled "Affiliate Provider COVID-19 Vaccine Policy Compliance" states in part, "Completed exemption request forms will be maintained by Associate Health in designated confidential files that are separate from the [Credentials Verification Organization] CVO or Hospital medical staff credentialing files and separate from Associate Health employment files..." SM #2 stated the facility is not following their policy.

As per SM #17 (Chief Nursing Executive) the facility is at one-hundred (100) percent compliance with employed staff vaccinations.

A review of the facility's policy titled, "Required Associate Immunization Program," approved 9/1/2021 and effective 2/23/2022 states in part, "COVID-19: Associates who have approved medical and religious exemptions from the vaccine are required to adhere to all recommended infection prevention guideline requirements. Associates exempt from receiving the COVID vaccine are required to adhere to masking and face protection requirements even when the mask mandate is lifted. Additional measures, such as weekly testing, may be implemented as needed. Medically and religiously exempted associates shall self-monitor for symptoms, stay home from work when experiencing COVID related symptoms following the organization's screening process (unless crisis staffing plan is in effect). The policy fails to delineate "additional" precautions intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19. The listed measures are the standard mitigation measures for all employees and the "additional measures" listed are not clearly defined.

SM #11 provided a "Workday" education document that is provided to employees with instructions for how employees are to submit COVID-19 vaccinations into the "Workday" system. SM #11 referred to the picture in the document showing a drop-down menu that allows employees to select "Booster" under the "Vaccination Event Type". There facility provided no other documentation regarding a process for tracking and securely documenting the COVID-19 vaccination for any staff who have obtained any booster doses as recommended by CDC.

A review of the facility's document titled, "Required Associate Immunization Program," approved 9/1/2021 and effective 2/23/2022, contains no evidence of a process for tracking and securely documenting the COVID-19 vaccination status for all staff who are not fully vaccinated. Staff Member #11 provided a document titled, "Regulatory Survey: Human Resources Standard Operating Procedure (SOP)," which contained no creation, reviewed, or approved dates. The document states in part, "CMS Survey Regarding COVID Compliance...Utilize the roster found on BSMH Central... The document contains no evidence of how the roster is secured." The document states in part, "Step 2: Survey specific to CMS and COVID compliance includes: 1. List of all associates for our facility. 2. Associates' work location (department). 3. Date of 1st Vaccine. 4. Date of 2nd Vaccine. 5. Type of vaccine. 6. Identification of Exemptions. 7. Calculations for: a. Number and percentage of staff fully vaccinated. b. Number and percentage of staff partially vaccinated. c. Number and percentage of staff exempt. d. Number and percentage of staff on temporarily delay (such as previously when a vaccine wasn't readily available). e. Number and percentage of staff unvaccinated. f. Total number of staff employed..." The document fails to clearly delineate a process for tracking and documenting information provided by those staff who have requested, and for who the hospital has granted, an exemption from the staff COVID-19 vaccination requirements and for those who are temporarily delayed from receiving the vaccine.

The facility's policy and SOP document failed to include a process for tracking and securely documenting COVID-19 vaccination status for any contractors, other than affiliate providers who fall under the policy titled "Affiliate Provider COVID-19 Vaccine Policy Compliance", such as students, Ensemble Health registration staff, vendors, etc... A review of the document titled "Regulatory Survey: Human Resources Standard Operating Procedure (SOP)," states in part "Regulatory Survey and Non-Associate Health Data: Step 1: Associate Health does not manage or track compliance data for non-associates. However, all groups are held to the same standard and tracking is maintained by the following contacts below: Vendors/Contractors = Supply Chain (BSMH Market Representative). Students = Medical Education Group (market specific) *See attachment AMENDED TEMPLATE LETTER - FOR USE WITH ALL ACTIVE CLINICAL EXPERIENCE AGREEMENTS RECEIVING NOTICE OF BSMH COVID-19 VACCINE POLICY IN MARKET 1.25.22". A review of the policy titled, "Supply Chain Vendor Access Management" approved 2/2/2021 and effective 2/2/2021 states in part, "Procedure: A. Registration: 1. Before accessing BSMH Facilities, Supplier Representatives must register, and be compliant, with BSMH's web-based supplier Credentialing System as required by the Supply Chain department. Representatives will need to complete all applicable credentialing requirements based on their role and the level of site access required. Failure to complete these requirements, including the vendor health requirements (i.e. flu shot, bloodborne pathogens, etc) will result in the vendor being denied access to the facility."

A review of the facility's document titled, "Required Associate Immunization Program," approved 9/1/2021 and effective 2/23/2022, contains the documentation, "Vaccine Compliance: BSMH will comply to all federal and state guidelines. Associates out of compliance with published deadlines without an approved exemption, will be subject to progressive discipline, up to and including termination. Progressive discipline will occur retrospective to the established deadline for COVID vaccine requirement." The facility's policy failed to clearly define the CMS established deadline for COVID vaccine requirement. SM #6 stated that their internal deadline for compliance for affiliate providers is 4/23/2022.

A review of the facility's policy titled "Affiliate Provider COVID-19 Vaccine Policy Compliance," states in part:
...V. Exemption Request:
...Exemption requests will be reviewed by a BSMH multi-disciplinary team ("BSMH Exemption Review Body") consistent with the COVID-19 Vaccine Requirements. Completed exemption request forms will be maintained by Associate Health in designated confidential files that are separate from the [Credentials Verification Organization] CVO or Hospital medical staff credentialing files and separate from Associate Health employment files...