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The Condition of Participation: Quality Assessment and Performance Improvement (QAPI) Program was out of compliance.

Findings included:

1.) Hospital A's QAPI Program failed for one patient (Unsampled Patient #1) in a total sample of ten patients to ensure Emergency Department data collected was used and monitored the effectiveness and safety of services and quality of care.

Refer to TAG: A-0273 Data Collection & Analysis.

2.) Hospital A's QAPI Program failed for one patient (Unsampled Patient #1) in a total sample of ten patients to ensure a thorough investigation and analysis, following Unsampled Patient #1's adverse patient event (departure from the Emergency Department) to identify and reduce medical errors and adverse patient events.

Refer to TAG: A-0286 Patient Safety, Medical Errors & Adverse Events.

3.) Hospital A Executives (Governing Body) failed for one patient (Unsampled Patient #1) in a total sample of ten patients to ensure full authority and responsibility for operations of Hospital A.

Refer to TAG: A-0309 Executive Responsibilities.

Based on records reviewed and interviews Hospital A Quality Assessment and Improvement (QAPI) Program failed for one patient (Unsampled Patient #1) in a total sample of ten patients to ensure Emergency Department data collected was used and monitored the effectiveness and safety of services and quality of care.

Findings included:

Regarding Unsampled Patient #1:

Hospital B report, dated 11/4/2021, indicated Hospital B suspected an improper transfer. Hospital B report indicated a Fire Rescue Run Note (EMS, Emergency Medical Services) indicated on arrival to Hospital A, EMS (ambulance crew) was informed by Hospital A's Emergency Room Charge Nurse that Unsampled Patient #1 would have to be transferred to the waiting room in a chair as there were currently no empty beds available in Hospital A's Emergency Department (ED). The ambulance crew informed the Charge Nurse that Unsampled Patient #1 was unable to sit in a chair because Unsampled Patient #1 was bed-confined and oxygen dependent (required supplemental oxygen). Hospital B report indicated the Charge Nurse stated the ambulance crew would have to wait with Unsampled Patient #1, with Unsampled Patient #1 on the ambulance stretcher for over an hour before a bed became available. Unsampled Patient #1 was informed (unclear by who) that he/she would have to wait on the ambulance stretcher for more than an hour and possibly longer before receiving medical care; then Unsampled Patient #1 requested not be seen at Hospital A. Hospital B report indicated the ambulance crew agreed that this (the transfer) would be in the best interest of the patient's (Unsampled Patient #1) health and safety and the ambulance crew transported Unsampled Patient #1 to Hospital B. Hospital B report indicated Hospital B Emergency Department Note indicated Unsampled Patient #1 was severely combative and yelling with hallucinations. Hospital B report indicated Unsampled Patient #1's transplant team (organ transplant team) requested an evaluation at Hospital A and then for Unsampled Patient #1 to be transferred to Hospital C (a hospital that provided organ transplant services). Hospital B report indicated that reportedly the EMS transported Unsampled Patient #1 to Hospital A, however due to prolonged wait times, that would have required the ambulance crew to stay with the patient for a prolonged period of time at Hospital A, and Unsampled Patient #1 was transported to Hospital B.

Regarding Hospital A investigation:

The document titled Steward Health Care System, LLC; Quality and Patient Safety Plan, dated 7/2020 and approved by Hospital A on 9/8/2020, indicated the Quality and Safety Committee of the Board of Directors (Governing Body) was responsible for Regulatory Activities and Patient Safety. The Quality and Patient Safety Plan indicated they oversaw the hospital-wide patient safety program to ensure the program included safety issues from potential harm events or no-harm events to sentinel events (errors of harm) as part of medical error reduction efforts. The Quality and Patient Safety Plan indicated the Quality and Safety Committee was responsible for setting the expectation that there was effective analysis and corrective actions for medical errors and near misses (of adverse patient events).

Hospital A's policy titled Emergency Department Nursing Triage, dated 11/23/2020, indicated all patients received a rapid Triage assessment including an Emergency Severity Index (ESI) score to determine if the patient required immediate evaluation and treatment.

ESI Key:

ESI 1: Immediate, life-saving intervention requiring trauma level resources to stabilize the patient.

ESI 2: Urgent, high risk of worsening condition requiring many resources to stabilize the patient.

ESI 3: Stable, with multiple types of resources needed to investigate or treat (such as lab tests plus X-ray imaging)

ESI 4: Stable, with only one type of resource anticipated (such as only an X-ray, or only sutures)

ESI 5: No resources needed to stabilize the patient.

Hospital A's policy titled Emergency Medical Treatment and Active Labor Act (EMTALA), dated 7/6/2021, indicated all patients who presented to the Hospital's Dedicated Emergency Department (DED) or on Hospital A property and requested examination or treatment of a potential Emergency Medical Condition (EMC), would receive an appropriate Medical Screening Examination.

During the interview, at 9:30 A.M. on 11/9/2021, with the Chief Medical Officer (CMO) and Risk Manager #1, the CMO said EMS brought Unsampled Patient #1 to Hospital A's ED because Unsampled Patient #1 was demonstrating agitated behaviors at the nursing facility; Hospital A did not register Unsampled Patient #1 (into the ED Registration Log). The CMO said Hospital A did not know Unsampled Patient #1's name. The CMO said Hospital A did not provide Unsampled Patient #1 with a Triage (the clinical assessment of Unsampled Patient #1's presenting signs and symptoms at the time of arrival at Hospital A, in order to prioritize when the patient would be seen by a physician or other qualified medical personnel). The CMO said Hospital A investigated the event (Unsampled Patient #1 presentation and departure from the ED) and Hospital A determined that the event was not an EMTALA violation. The CMO said Hospital A's ED staff did not report the event to Hospital A; the Nursing Supervisor was not notified on the evening of the event. The CMO said Hospital A had a process for registration of a patient that Hospital A did not know the patient's name; the patient could be registered as a John Doe or Jane Doe.

Risk Manager #1 said on the evening of 10/18/2021, Hospital A did not know the time of Unsampled #1's arrival time by EMS, that the ED was overwhelmed and out of stretchers (actual stretchers or a place to care for a patient on a stretcher was unknown), the Charge Nurse had six of her own patients including Charge Nurse responsibilities. Risk Manager #1 said on the evening of 10/18/2021, Registration Clerk #2 covered Registration Clerk #1's dinner break and was doing registration for patients brought to the ED by EMS. (Risk Manager #1 did not know that Registration Clerk #3 was the Registration Clerk at the time of Unsampled Patient #1's presentation to the ED; (Refer to TAG: A-386: Registration Clerk #3's interview).

During the interview, at 1:15 P.M. on 11/10/2021, the Chief Medical Officer (CMO) said they (the ambulance crew) took Unsampled Patient #1 away from us, they (ambulance crew) "stole" our patient (Unsampled Patient #1), before Hospital A registered Unsampled Patient #1.

During the interview, at 4:30 on 11/10/2021, the Patient Access (Registration) Director said Registration Clerks could register patients whose name was unknown as a John Doe or Jane Doe.

Hospital A provided no documentation to indicate they used their investigation data collected to evaluate their effectiveness and safety of Emergency Services and quality of care provided to Emergency Department patients despite knowing:

1.) Unsampled Patient #1's presentation by EMS, oxygen dependent and bed-confined, and departure by EMS without registration to Hospital A and an appropriate Medical Screening Examination,

2.) The information that the ED was overwhelmed, out of stretchers and the Charge Nurse had six of her own patients including Charge Nurse responsibilities.

3.) Hospital A had a policy to initiate a Code Help to decompress the Emergency Department (Refer to TAG: A-0286 Patient Safety, Medical Errors & Adverse Events.

4.) Hospital A had a process to register patients whose name was unknown.

5.) Hospital A ED Staff did not report the event to Hospital A.

Based on observations, records reviewed and interviews Hospital A's Quality Assessment and Improvement Program (QAPI) failed for one patient (Unsampled Patient #1) in a total sample of ten patients to ensure a thorough investigation of analysis following Unsampled Patient #1's adverse patient event [departure from the Emergency Department (ED)] to identify and reduce medical errors.

Findings included:

Hospital B report, dated 11/4/2021, indicated Hospital B suspected Hospital A improperly transferred Unsampled Patient #1 to Hospital B (on 10/18/2021).

Regarding Hospital A investigation of the 10/18/2021 event:

Hospital A's policy titled Emergency Medical Treatment and Active Labor Act (EMTALA), dated 7/6/2021, indicated all patients who presented to Hospital A's dedicated (DED) or on Hospital A property and requested examination or treatment of a potential Emergency Medical Condition (EMC), would receive an appropriate Medical Screening Examination.

Hospital A's policy titled Emergency Department Nursing Triage, dated 11/23/2020, indicated all patients received a rapid Triage assessment including an Emergency severity Index (ESI) score to determine if the patient required immediate evaluation and treatment. Refer to TAG:

Hospital A policy titled Code Help (Code H), dated 2/4/2020, indicated a Code Help would be initiated when the ED was unable to accept any new patients or was unable to care for existing patient because the acuity impeded provision of safe patient care. The Code Help policy indicated the ED Charge Nurse or ED Attending (physician) on duty notified the Chief of the Emergency services or Designee and the ED Nursing leader and Hospital A nursing supervisor whenever the boarding or back up of patients in the ED prevented timely evaluation and treatment of patients in order to activate Code Help to mobilize Hospital A resources to improve throughput. The Code Help policy indicated the decision to institute a Code Help was made by the ED Attending or charge physician when the ED was unable to care for or accept existing patients in a licensed treatment space and there were admitted patients waiting on the ED for an inpatient bed. The Code Help policy indicated a NEDOCS (National Emergency Department Overcrowding Scale score used to estimate the severity of overcrowding in the ED) greater than 181 triggered a Code Help.

During the interview, at 9:30 A.M. on 11/9/2021, with the Chief Medical Officer (CMO) and Risk Manager #1, the Chief Medical Officer (CMO) said Hospital A did not know Unsampled Patient #1's name. The CMO said Hospital A did not provide Unsampled Patient #1 with a triage. The CMO said that Hospital A investigated the event (Unsampled Patient #1 presentation and departure) with the Corporation (Steward Health Care System) and they determined that the event was not an Emergency Medical Treatment and Labor Act (EMTALA) violation. The CMO said Hospital A's ED staff did not report the event to Hospital A, the Nursing Supervisor was not notified on the evening of the event. The CMO said Hospital A could have registered Unsampled Patient #1 as a John Doe or Jane Doe. Risk Manager #1 said on the evening of 10/18/2021, Hospital A did not know the time of Unsampled #1's arrival time by EMS, that the ED was overwhelmed and out of stretchers (actual stretchers or a place to care for a patient on a stretcher was unknown), the Charge Nurse had six of her own patients including Charge Nurse responsibilities.

Risk Manager #1 said on the evening of 10/18/2021, Registration Clerk #2 was covering Registration Clerk #1's dinner break and was doing registration for patients brought to the ED by Emergency Medical Services. (Risk Manager #1 did not know that Registration Clerk #3 was the Registration Clerk at the time of Unsampled Patient #1's presentation to the ED; (Refer to Registration Clerk #3's interview).

Emergency Medical Treatment and labor Act of 1986 EMTALA Educational Slides, dated 5/2021, indicated if the ED staff were unable to immediately attend to the patient because they were dealing with multiple trauma cases, as the EMS provider to stay with the patient.

During the interview, at 1:00 P.M. on 11/9/2021, Risk Manager #1 said the source of "if the ED staff were unable to immediately attend to the patient because they are dealing with multiple trauma cases, as the EMS provider to stay with the patient", as above, was Hospital A's requirement with a worst-case scenario.

Registration Clerk #1:

During the interview, at 2:00 P.M. on 11/9/2021, Registration Clerk #1 said her responsibilities on the evening of 10/18/2021 was to register patients that presented to the ED by ambulance. Registration Clerk #1 said possibly between 7:30 P.M. and 8:00 P.M. she went to dinner and Registration Clerk #2 covered her responsibilities to register patients presenting to the ED by ambulance. Registration Clerk #1 said on return from dinner she heard that an ambulance had left and no one made an issue of it. Registration Clerk #1 said it was a "crazy" night" ambulances waiting at the holding at the desk (registration area for ambulances), ambulances waiting for more than one hour and Hospital A knew how busy we were, we had no beds, no stretchers and no nurses. Registration Clerk #1 said she was not told to register the patient (Unsampled Patient #1) as a John Doe (name used when Hospital A did not know the patient's name).

Registration Clerk #2:

During the interview, at 3:15 P.M. on 11/9/2021, Registration Clerk #2 said he covered the dinner break for Registration Clerk #1 (on the evening of 10/18/2021), the ED was very busy, there were three ambulances waiting. Registration Clerk #2 said he did not see Unsampled Patient #1 nor see the ambulance present, as Registration Clerk #3 volunteered to assist and covered the ambulance bay (area). Registration Clerk #2 said he did not tell Hospital A that Registration Clerk #3 was covering the ambulance bay at the time of Unsampled Patient #1's arrival to the ED.

Registration Clerk #3:

During the interview, at 9:10 A.M. on 11/10/ 2021, Registration Clerk #3 said she volunteered to help with ambulance registration as Registration Clerk #2 was busy. Registration Clerk #3 said she saw the ambulance come in, she was speaking to the ambulance crew to obtain Unsampled Patient #1's name and was interrupted by the Charge Nurse who asked the ambulance crew why they were here (appropriately gathering initial patient information). Registration Clerk #3 said the Charge Nurse informed the ambulance crew that there was approximately a fourteen hour wait, they could wait or bring the patient to a different hospital. Registration Clerk #3 said she asked the Charge Nurse if they were going to put this patient in (register Unsampled Patient #1) and the Charge Nurse said not yet. Registration Clerk #3 said the Charge Nurse was in charge and that she (Registration Clerk #3) did what the Charge Nurse told her to do and waited to register Unsampled Patient #1. Registration Clerk #3 said the ambulance crew talked to Unsampled Patient #1, went back to the Charge Nurse and the ambulance crew told the Charge Nurse they were going to bring Unsampled Patient #1 to another hospital. Registration Clerk #3 said she saw the ambulance leave and did not have a chance (to obtain Unsampled Patient #1's name and register Unsampled Patient #1) before the ambulance crew left (departed). Registration Clerk #3 said she had never seen this before, thought it was okay (appropriate), because the Charge Nurse said not yet (wait to register Unsampled Patient #1), and because the (Unsampled Patient #1) can go to a different hospital. Registration Clerk #3 said Hospital A had a process to register a patient whose name was unknown. Registration Clerk #3 said no one (from Hospital A) had talked to her about this until today.

During the interview, at 1:15 P.M. on 11/10/2021, the Chief Medical Officer (CMO) said they (EMS) took Unsampled Patient #1 away from us, the EMS staff "stole" our patient (Unsampled Patient #1), before Hospital A registered Unsampled Patient #1.

Regarding the 11/21/2021 Code Help:

The policy titled Code Help, dated 11/19/2021 (revised during the Survey), indicated the ED Charge Nurse or ED Attending (Physician) on duty notified the Chief of Emergency Services and the ED Nursing Leader and Hospital Nursing Supervisor whenever the boarding or back up of patients in the ED prevented timely evaluation and treatment of patients in order to activate Code Help to mobilize Hospital A resources to improve throughput. The Code Help policy indicated the decision to institute a Code Help was made by the ED Attending or Charge Physician when the ED was unable to care for or accept existing patients in a licensed treatment space and there were admitted patients waiting in the ED for an inpatient bed. The Code Help policy indicated in addition a CEDOCS Score greater than 181 may also trigger a Code Help (this revised Code Help policy changed the NEDOCS Score from the previous policy to CEDOCS Score).

Community Emergency Department Overcrowding Score (CEDOCS) Score Interpretation, A score of:

CEDOC Key

-1-20 the ED was not busy,

-21-60 the ED was busy,

-61-100 the ED was extremely busy but not overcrowded,

-101-140 the ED was overcrowded,

-141-180 the ED was severely overcrowded,

-181-200 the ED was dangerously overcrowded.

The study (article) titled Overcrowding and Its Association with Patient Outcomes in a Medium-Low Volume ED (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5633091/) indicated the Community Emergency Department Overcrowding Score (CEDOCS); under six different levels of crowding (not busy, busy, extremely busy, overcrowded, severely overcrowded, and dangerously overcrowded) determined ED crowding status (score). The CEDOCS was derived in EDs ranging from low to high volume and was appropriate for crowding measurement across a wide range of ED annual volume. The article concluded that the study showed negative patient outcomes occurred with increased levels of ED crowding and recommended crowding reports, alerts should be initiated earlier when the ED was classified as extremely busy instead of overcrowded statuses.

During the interview, at 9:00 A.M. on 11/23/2021, the CNO said the ED Charge Nurses generated a CEDOC Score at 6:00 A.M., 10:00 A.M. 2:00 P.M. 6:00 P.M., 10 P.M. 2:00 A.M. (every four hours). The Chief Nursing Officer (CNO) said the ED Charge Nurse discussed activating the Code Help with the Nursing Supervisor and a Code Help was initiated (at approximately 10:30 P.M.) on 11/21/2021. The CNO said the CEDOC Score was 118, the Code Help went well, and that the ED Charge Nurse required emotional support. The CNO said that there were no ambulances waiting with Patients to be triaged. The CNO said Hospital A was full and staffed to capacity.

During the interview, at 4:00 P.M. on 11/23/2021, ED Registered Nurse (RN) #3 said she was on duty the night shift after the Code Help was initiated (on 11/21/2021) and when she arrived there was no one at the desk (the ED ambulance Triage desk), the ED was very busy with a couple of ambulances waiting for beds at the ambulance Triage area, four ambulances coming, only nine nurses, a lot of admissions and 19 psychiatric patients. ED RN #3 said no one came down, no supervisor and it did not get better after initiating the Code Help. ED RN #3 said the Evening Charge Nurse was told not to call (initiate) the Code Help because it (the ED did not meet criteria). ED RN #3 said (on her shift) there were two patient arrests (emergency codes), one patient died, a couple of trauma patients, and transfers because there were no Intensive Care Unit beds (in Hospital A). ED RN #3 the ED started using the CEDOC Scores yesterday to decompress the ED and that it is a problem when there were no beds. ED RN #3 said there were 35 patients holding in the ED waiting an inpatient admission bed. ED RN #3 said patients were waiting nine to fourteen hours in the waiting room.

During the interview, at 2:15 P.M. on 11/23/2021, the Chief Nursing Officer said Hospital A had 174 beds, safely admitted patients to staffed beds to have one Registered Nurse to care for five patients; that this does back up the ED and this is when we activate the Surge Plan (implemented during the Survey).

Hospital A Licensure, dated 11/6/2020, indicated Hospital A licensed for 18 Intensive Care Unit Beds and (168 Medical, Surgical beds with 6 Pediatric beds located on a Medical Surgical Unit) for a total of 174 Medical Surgical inpatients.

During a tour of the ED, at 11:30 A.M. on 11/10/2021, the Surveyor observed the ED had forty-six bays (beds).

The Ambulance Report, dated 11/18/2021-11/22/2021, indicated approximately 673 ambulances presented patients to Hospital A ED in five days (approximately one ambulance every ten minutes).

Regarding the 11/25/2021 Code Help:

1.) During the interview, at 10:37 A.M. on 12/1/2021, ED Registered Nurse #4 said a Code Help was initiated on 11/25/2021, and this did little to nothing (to decompress the ED), no one came, just phone calls. ED Registered Nurse #4 said the Nursing Supervisor did not come to the ED. ED Registered Nurse #4 said there was or were in the ED (the following):

-Four ambulances (ambulance crews with patients) waiting at the ambulance bay Triage area and two were traumas,

-Eighty-three patients in the ED with twenty-six patient holding for Hospital A admission, two were Intensive Care Unit (ICU) admissions and one of the ICU patients with Diabetic Ketoacidosis (DKA, a serious complication of diabetes that can be life-threatening) did not have a nurse and the ICU patient was in the hallway; there were six hallway patients without nurses,

-Twenty-one patients waiting in the waiting room, with a greater than one-hour to Triage and a five hour wait time.

ED Registered Nurse #4 said when two beds did become available there were no transporters to bring the patients from the ED to the in-patient Hospital A bed. ED Registered Nurse #4 said Hospital A was trying to persuade anyone from initiating a Code Help and that the ED Staffs were trying to prevent someone from dying.

2.) ED Registered Nurse #4 said during the Code Help, on 11/25/2021, an ED Physician brought in two patients for Monoclonal Antibody Therapeutics (COVID-19 treatment). ED Registered Nurse #4 said these patients (with an ESI of 3 or 4) took priority and were taken before sick patients with an ESI of 2, in the ED and the two patients required a Registered Nurse to provide the intravenous administration for the treatment.

3.) ED Registered Nurse #4 said the CEDOC Score was 189 and the Surge Plan and Code Help policy were confusing. ED Registered Nurse #4 said Hospital A President called the ED and said they were going to have a meeting to look at appropriateness of initiating a Code Help. ED Registered Nurse #4 said the ED Nurse Director said that a CEDOC Score of 200 (was criteria to initiate a Code Help. ED Registered Nurse #4 said some Charge Nurses were hesitant to call a Code Help because Hospital A may not agree with their decision to initiate the Code Help. ED Registered Nurse #4 said the Code Help policy referred to Hospital A's Disaster Plan and that she was unsure if there really was a disaster plan (Emergency Management Plan).

Hospital A provided no documentation of Hospital A's Emergency Management Plan after Surveyor request.

4.) ED Registered Nurse #4 said the CEDOC required (the Charge Nurse to enter into the computer-based calculator) the number of ED visits per year (to generate the CEDOC Score) and Charge Nurses did not know the exact number of ED visits to enter. ED Registered Nurse #4 she used fifty-five thousand however was not sure if this was the correct number.

Hospital A provided no effective corrective actions to ensure:

-Hospital A investigation included corrective actions on decompressing the ED in accordance with their Code Help policy in order to provide an appropriate Triage, Medical Screening Examination and decompression of the ED.

-Patients received Emergency Services in accordance with Emergency Services policies for Triage and Medical Screening Examinations.

-the Code Help Policy and Surge Plan were clearly communicated to ED Charge Nurses for accurate initiation of Hospital A policies.

-Updating the Emergency Medical Treatment and labor Act of 1986 EMTALA Educational Slides, that indicated if the ED staff were unable to immediately attend to the patient because they were dealing with multiple trauma cases, ask the EMS provider to stay with the patient; to clearly include in the education; even if Hospital A could not immediately complete an appropriate Medical Screening Examination, Hospital A must still assess the individual's condition upon arrival to ensure that patients were appropriately prioritized, based on presenting signs and symptoms, to be seen by a physician or other Qualified Medical Practitioner for completion of the Medical Screening Examination, in accordance with EMTALA regulations.

-A clear process for handoff and covering of Registration Clerk breaks and meals; and confirming Registration Clerks registered all patients including those whose name was unknown.

-Procedures to include all key staff for interview and

-The focus of their investigation and shortage of effective corrective actions, considered dynamics occurring in the ED that resulted in the ambulance crew departure from Hospital A with Unsampled Patient #1 to another hospital.

Based on records reviewed and interviews Hospital A Executives (Governing Body) failed for one patient (Unsampled Patient #1) in a total sample of ten patients to ensure full authority and responsibility for operations of Hospital A.

Findings included:

1.) Regarding initiating the Code Help policy:

During the interview, at 9:30 A.M. on 11/9/2021 with the Chief Medical Officer (CMO) and Risk Manager #1, the Chief Medical Officer (CMO) said Hospital A did not register Unsampled Patient #1 (into the Emergency Department Log) and Hospital A did not provide Unsampled Patient #1 with a Triage [the clinical assessment of Unsampled Patient #1's presenting signs and symptoms at the time of arrival at Hospital A, in order to prioritize when the individual would be seen by a physician or other qualified medical personnel (QMP)]. The Manager #1 said on the evening of 10/18/2021 the Emergency Department was overwhelmed, out of stretchers (actual stretchers or a place to care for a patient on a stretcher was unknown), the Charge Nurse had six of her own patients including Charge Nurse responsibilities. Risk Manager #1 said on the evening of 10/18/2021. During the interview, at 1:15 P.M. on 11/10/2021, the Chief Medical Officer said if we could get past the Union (nurses' bargaining unit, commonly referred to as a union) was, we could help debulk the Emergency Department.

Hospital A provided no documentation to indicated Hospital Executives managed the Emergency Department capacity or capability when Hospital A did not have the capacity nor capability as Hospital A did not initiate their Code Help policy to decompress the Emergency Department.

2.) Regarding Provider in Triage:

Emergency Department Provider Staff Meetings Minutes: dated 12/15/2020, 2/17/2021, 4/14/2021, 5/12/2021, and 6/16/2021, indicated issues with Provider in Triage (PIT). The Emergency Department Provider Staff Meetings Minutes indicated the Massachusetts Nurses Association (MNA) was resistant on having an Advanced Practice Provider (Nurse Practitioner or Physician Associate) staff the Triage areas because it would slow-down the nurses. Emergency Department Provider Staff Meetings Minutes indicated having Advanced Practice Providers staff in Triage areas had decreased the number of patients that Leave the Emergency Department Without Being Seen (LWBS, that is, Hospital A registered the patient, however the patient departed the Emergency Department without a Medical Screening Examination) with the caveat that some of the patients that LWBS became elopements (patients Hospital A registered, provided a Medical Screening Examination and the patient then eloped, departed Hospital A, prior to a Provider discharging the patient from the Emergency Department).

Hospital A provided no documentation to indicate resolution of Emergency Department's Patient Care Delivery System regarding the utilization of Providers in Triage for almost one year (12/2020 to Survey) in order to provide an appropriate Medical Screening Examination and continue with the positive trajectory (improvement) of decreasing LWBS patients.

3.) Regarding patient elopement:

During the interview, at 10:37 A.M. on 12/1/2021, Emergency Department Registered Nurse #4 said an elderly patient with dementia (a disorder of the mental processes caused by brain disease or injury and marked by memory disorders, personality changes, and impaired reasoning) was brought in by ambulance and placed in a hall-way bed, on 11/25/2021. Emergency Department Registered Nurse #4 said a Physician could not find the patient as the patient had walked out of the Emergency Department (eloped unbeknownst to the Emergency Department staffs). State and Local Police located the Patient and the Patient was brought to another hospital for care.

4.) Contracted Services:

Transfer Agreements between Massachusetts General Hospital, dated 5/20/1997, Children's Hospital Boston, dated 3/1/2007 and Saint Elizabeth's Medical Center (Maternal & Newborn), dated 10/30/2008 indicated Contracted Services.

The document titled Workforce Solutions Agreement, dated 10/24/2017, and the document titled Services Agreement, dated 4/1/2020, indicated a Contracted Service for staffing services. The Contracts indicated no documentation that Hospital A's Governing Body's held responsibility for the Contract (generally signified by a signature representative of a Hospital Executive).

During the interview, at 8:00 A.M. on 11/12/2021, the Quality Director said the Transfer Agreements were not contracts, they were agreements that provided no service, and did not require monitoring.

During the interview, at 5:00 P.M. on 11/223/2021, the Chief Nursing Officer said that Hospital A used two contracted services for travel nurses. The Chief Nursing Officer said that they were Corporate Contracts and that the Corporation (Steward Health Care System) managed the contracts.

Hospital provided no documentation to indicate monitoring of Transfer Agreements nor Staffing Services (services provided through formal contracts, informal agreements) concurring with Governing Body responsibilities to ensure performance under a contract (agreement) were provided in a safe and effective manner, subject to hospital-wide quality assessment and performance improvement (QAPI) evaluation as other services provided directly by Hospital A (in accordance with the State Operations Manual, Appendix A, TAG: A-0084 of the Condition of Participation Governing Body).

The Condition of Participation: Emergency Services was out of compliance.

Findings included:

1.) Hospital A failed for one patient (Unsampled Patient #1) in a total sample of ten patients to ensure Emergency Services Medical Director was responsible for Hospital A's Emergency Services following Unsampled Patient #1's Emergency Department departure.

Refer to TAG: A-1102 Emergency Services Medical Director.

2.) Hospital A failed for one patient (Unsampled Patient #1) in a total sample of ten patients to ensure the Code Help policy and procedures were the continuing responsibility of the medical staff and implemented in accordance with the Code Help policy.

Refer to TAG: A-1104 Policies & Procedures.

3.) Hospital A's supervising and qualified member of the Medical Staff failed for one patient (Unsampled Patient #1) to activate Hospital A's Code Help policy in order to decompress the Emergency Department that was over capacity (not enough space) and under capability (not enough staff) on the evening of 10/18/2021 to care for patients seeking emergency services.

Refer to TAG: A-1111 Medical Supervisor of the Emergency Department.

4.) Hospital A failed to ensure adequate medical and nursing personnel qualified in emergency care to meet the written emergency procedures and needs anticipated by the facility. Hospital A failed to staff the Triage area with qualified emergency Department Staff when the Triage Registered Nurse was assigned to the Emergency Department for patient care.

Refer to TAG: A-1112 Qualified Emergency Services Personnel.

Based on records reviewed and interviews Hospital A failed for one patient (Unsampled Patient #1) in a total sample of ten patients to ensure Emergency Services Medical Director was responsible for Hospital A's Emergency Services following Unsampled Patient #1's Emergency Department departure.

Findings included:

During the interview, at 12:00 P.M. on 11/12/2021, the Emergency Department Chair said he was aware of the events of 10/18/2021 a couple of days later.

1.) Regarding Unsampled Patient #1 and regarding a thorough investigation following Unsampled Patient #1's departure from Hospital A's ED by EMS to another hospital:

Hospital B report, dated 11/4/2021, indicated Hospital B suspected an improper transfer. Hospital B report indicated a Fire Rescue Run Note (EMS, Emergency Medical Services) indicated on arrival to Hospital A, EMS (ambulance crew) was informed by Hospital A's Emergency Room Charge Nurse that Unsampled Patient #1 would have to be transferred to the waiting room in a chair as there were currently no empty beds available in Hospital A's Emergency Department (ED). The ambulance crew informed the Charge Nurse that Unsampled Patient #1 was unable to sit in a chair because Unsampled Patient #1 was bed-confined and oxygen dependent (required supplemental oxygen). Hospital B report indicated the Charge Nurse stated the ambulance crew would have to wait with Unsampled Patient #1, with Unsampled Patient #1 on the ambulance stretcher for over an hour before a bed became available. Unsampled Patient #1 was informed (unclear by who) that he/she would have to wait on the ambulance stretcher for more than an hour and possibly longer before receiving medical care; then Unsampled Patient #1 requested not be seen at Hospital A. Hospital B report indicated the ambulance crew agreed that this (the transfer) would be in the best interest of the patient's (Unsampled Patient #1) health and safety and the ambulance crew transported Unsampled Patient #1 to Hospital B. Hospital B report indicated Hospital B Emergency Department Note indicated Unsampled Patient #1 was severely combative and yelling with hallucinations. Hospital B report indicated Unsampled Patient #1's transplant team (organ transplant team) requested an evaluation at Hospital A and then for Unsampled Patient #1 to be transferred to Hospital C (a hospital that provided organ transplant services). Hospital B report indicated that reportedly the Emergency Medical Services transported Unsampled Patient #1 to Hospital A, however due to prolonged wait times, that would have required the ambulance crew to stay with the patient for a prolonged period of time at Hospital A, and Unsampled Patient #1 was transported to Hospital B.

During the interview, at 9:30 A.M. on 11/9/2021, the Chief Medical Officer said Hospital A investigated the event (Unsampled Patient #1 presentation and departure) and Hospital A determined that the event was not an Emergency Medical Treatment and Labor Act (EMTALA) violation as they (the ambulance crew) took Unsampled Patient #1 away from us, the ambulance crew "stole" our patient (Unsampled Patient #1), before Hospital A registered Unsampled Patient #1.

During the interview, at 5:00 P.M. on 11/9/2021, the Chief Medical Officer (CMO) said he did not know why Hospital B texted (notified) him instead of the notifying the ED Medical Director (ED Chief) or the ED (ED Supervising Physician(s) on duty the evening of 10/18/2021).

2.) Regarding dynamics occurring in the ED, on 10/18/2021 and 11/21/2021 ED QAPI responsibilities.

Hospital A policy titled Code Help (Code H), dated 2/4/2020, indicated a NEDOCS (National Emergency Department Overcrowding Scale score used to estimate the severity of overcrowding in the emergency department) greater than 181 triggered a Code Help

During the interview, at 11:30 A.M. on 11/12/2021, the Quality Director said the (NEDOC) Score was 200 at 12:00 P.M. on 10/18/2021.

During the interview, at 12:00 P.M. on 11/12/2021, the ED Chair (ED Medical Director) said the numbers of patients in the ED was greater than one hundred for the last three to four months with approximately twenty patients waiting in the waiting room. The ED Chair said normally fifty to seventy-five patients were in the ED with waiting room patients. The ED Chair said (on the evening of 10/18/2021) there were three ambulances needing registration and a Medical Screening Examination, one patient Left Without Being Seen (LWBS) and two others.

Based on records reviewed and interviews Hospital A failed for one patient (Unsampled Patient #1) in a total sample of thirty-two patients to ensure the Code Help policy and procedures were the continuing responsibility of the Medical Staff and implemented in accordance with the Code Help policy.

Findings included:

Hospital B report, dated 11/4/2021, indicated Hospital B suspected an improper transfer. Hospital B report indicated Unsampled Patient #1's transplant team (organ transplant team) requested an evaluation at Hospital A and then for Unsampled Patient #1 to be transferred to Hospital C (a hospital that provided organ transplant services). Hospital B report indicated that reportedly the Emergency Medical Services transported Unsampled Patient #1 to Hospital A, however due to prolonged wait times, that would have required the ambulance crew to stay with the patient for a prolonged period of time at Hospital A, and Unsampled Patient #1 was transported to Hospital B.

Hospital A policy titled Code Help (Code H), dated 2/4/2020, indicated a Code H would be initiated when the Emergency Department (ED) was unable to accept any new patients or was unable to care for existing patient because the acuity impeded provision of safe patient care. The Code Help policy indicated the ED Charge Nurse or ED Attending (physician) on duty notified the Chief of the Emergency services or Designee and the ED Nursing leader and Hospital A nursing supervisor whenever the boarding or back up of patients in the ED prevented timely evaluation and treatment of patients in order to activate Code H to mobilize Hospital A resources to improve throughput. The Code Help policy indicated the decision to institute a Code H was made by the ED Attending or charge physician when the ED was unable to care for or accept existing patients in a licensed treatment space and there were admitted patients waiting on the ED for an inpatient bed. The Code Help policy indicated a NEDOCS (National ED Overcrowding Scale score used to estimate the severity of overcrowding in the ED) greater than 181 triggered a Code Help.

During the interview, at 9:30 A.M. on 11/9/2021, Risk Manager #1 said on the evening of 10/18/2021, the ED was overwhelmed and out of stretchers (actual stretchers or a place to care for a patient on a stretcher was unknown), the Charge Nurse had six of her own patients including Charge Nurse responsibilities, and Registration Clerk #1 was at dinner (supper) with Registration Clerk #2 covering patient registration of patients brought to the ED by EMS for Registration #1's dinner break.

During the interview, at 9:00 A.M. on 11/10/2021, Hospital A Emergency Department Registered Nurse #1 she did not activate the Code Help policy (on 10/18/2021) because it does not do anything.

During the interview, at 11:30 A.M. on 11/12/2021, the Quality Director said the (NEDOC) Score was 200 at 12:00 P.M. on 10/18/2021.

During the interview, at 10:00 A.M. on 11/23/2021, the ED Nurse Director said a Code Help was initiated for the ED the night before last (11/21/2021) that did not quite meet the criteria to activate a Code Help, there were eight patients waiting in the waiting room (for emergency services), there was a surge of ambulances that prompted panic for a lot of patients presenting at the same time, the patient acuity was not high at the time and the Charge Nurse required emotional support. The ED Nurse Director said it was a communication issue because the Nursing Supervisor new Hospital A had inpatient beds (to transfer patients in the ED waiting inpatient admission).

During the interview, at 4:00 P.M. on 11/23/2021, ED Registered Nurse (RN) #3 said she was on duty the night shift after the Code Help was initiated (on 11/21/2021) and when she arrived there was no one at the desk (the ED ambulance Triage desk), the ED was very busy with a couple of ambulances waiting for beds at the ambulance Triage area, four ambulances coming, only nine nurses, a lot of admissions and 19 psychiatric patients. ED RN #3 said no one came down, no supervisor and it did not get better after activating the Code Help. ED RN #3 said the Evening Charge Nurse was told not to call (activate) the Code Help because it (the ED did not meet criteria). ED RN #3 said (on her shift) there were two patient arrests (emergency codes), one patient died, a couple of trauma patients, and transfers because there were no Intensive Care Unit beds (in Hospital A). ED RN #3 the ED started using the CEDOC Scores yesterday to decompress the ED and that it is a problem when there were no beds. ED RN #3 said there were 35 patients holding in the ED waiting an inpatient admission bed. ED RN #3 said patients were waiting nine to fourteen hours in the waiting room.

Based on records reviewed and interviews Hospital A's supervising and qualified member of the Medical Staff failed for one patient (Unsampled Patient #1) to activate Hospital A's Code Help policy in order to decompress the ED that was over capacity (not enough space) and under capability (not enough staff) on the evening of 10/18/2021 to care for patients seeking emergency services.

Findings included:

Hospital A policy titled Code Help (Code H), dated 2/4/2020, indicated a Code H would be initiated when the ED was unable to accept any new patients or was unable to care for existing patient because the acuity impeded provision of safe patient care. The Code Help policy indicated the decision to institute a Code Help was made by the ED Attending or Charge Physician the ED was unable to care for or accept existing patients in a licensed treatment space and there were admitted patients waiting on the ED for an inpatient bed.

During the interview, at 12:00 P.M. on 11/12/2021, the Emergency Department Chair said he was aware of the events of 10/18/2021 a couple of days later.

Hospital A provided no documentation to indicate an ED Attending or Charge Physician (Supervising Physician) initiated a Code Help in accordance with Hospital A Code Help policy

Based on records reviewed and interviews Hospital A failed to ensure adequate medical and nursing personnel qualified in emergency care to meet the written emergency procedures and needs anticipated by the facility. Hospital A failed to staff the Triage area with qualified ED staff when the Triage Registered Nurse was assigned to the ED for patient care.

Findings included:

The document titled Emergency Department Senior Clinical Assistant Annual Competency, dated 2021, indicated no indication Hospital A approved Emergency Department Senior Clinical Assistants to perform in the role as a Greeter when the Triage Nurse was reassigned to the main patient care area (core) of Emergency Department to augment Nursing staffing needs in the core of the Emergency Department.

The document titled Department Specific Competency Checklist, Emergency Department Senior Clinical Assistant, dated 2021, indicated no indication Hospital A approved Emergency Department Senior Clinical Assistants to perform in the role as a Greeter when the Triage Nurse was reassigned to the main patient care area (core) of Emergency Department to augment Nursing staffing needs in the core of the Emergency Department.

The Department Specific Competency Checklist, Emergency Department Senior Clinical Assistant indicated no role description, functions nor patient behaviors immediately reportable to the Charge Nurse to assume a patients triage. (For example, the Department Specific Competency Checklist,

Emergency Department Senior Clinical Assistant indicated no education nor guidance for the Senior Clinical Assistant to immediately report to the Charge patient life-threatening behaviors or reports that included signs of stroke, heart attack, hemorrhage; reports of suicide, changes in mental status, pediatric or geriatric patients.

During the interview, at 10:00 A.M. on 11/23/2021, the ED Nurse Director said the ED Triage Nurse rarely took a patient assignment and when the Triage Nurse was required to take a patient assignment, a greeter (a paramedic) covered the Triage area and worked with the Charge Nurse. The ED Nurse Director said the greeters do not perform Triage (patient Triage assessments) and she could not remember if a greeter covered the Triage area when the Triage Nurse was required to take a patient assignment.

During the interview, at 4:00 P.M. on 11/23/2021, ED Registered Nurse (RN) #3 said there was no Triage Nurse and a tech was in Triage who notified the Charge Nurse (of a patient presenting to the ED for emergency services). ED RN #3 said the techs ask questions however the techs do not document in the patient medical record, she takes the information and she documents their information and does not document that she was a recorder of their information. ED RN #3 said it depended on the level of the staff covering Triage what knowledge they (paramedic, tech, nursing assistant, medics) had about patient signs and symptoms (extreme pain, stroke, pediatrics) to immediately notify the Charge Nurse. ED RN #3 said her shift was down two nurses, no beds for ambulances, nurses had up to nine patients and complained that the ED was unsafe. ED RN #3 said the Nursing Supervisor told the Evening Charge Nurse that Hospital A had five beds to transfer ED patients however there were no five beds and two patients were transferred on the night shift.

During the interview, at 10:37 A.M. on 12/1/2021, ED Registered Nurse #4 said on 11/28/2021 there was no on coming Triage Nurse to take over for the off going Triage Nurse at the change of shift; the Charge Nurse said a tech would receive report from the off going Triage Nurse. ED Registered Nurse #4 said the tech was then responsible for doing the same functions as a Triage Nurse, wrote the information on paper and the Charge Nurse documented the information in the patient's medical record without ever seeing the patient and the tech was responsible for patients in the waiting room. ED Registered Nurse #4 this has been going on for the past few months.

Hospital A provided no documentation to indicate ED Staff assigned to the Triage Area (when a Triage Nurse was not present) were qualified.