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Based on medical record review, hospital policy review, review of incident reports, and staff interview, it was determined the hospital failed to ensure an effective, ongoing, hospital-wide, data-driven QAPI program focused on improved health outcomes. This resulted in the inability of the hospital to monitor the quality of patient care services and safety. Findings include:

Refer to A - 286 as it relates to the failure of the hospital to ensure adverse patient events were identified, analyzed, and actions were taken to prevent further incidents.

The cumulative effect of these negative systemic practices prevented the hospital from evaluating the care and services it provided.

Based on policy review, medical record review, EMS report review, and staff interview, it was determined the hospital failed to ensure an adverse event was identified and analyzed for 1 of 1 patient (Patient #21) whose record included an adverse event. This resulted in the lack of analysis and evaluation of safe patient care and impeded the hospital from taking corrective action. Findings include:

A hospital policy, "SENTINEL EVENT (Root Cause Analysis)," revised 4/24/18, was reviewed. The policy included the definition of a Critical Patient Safety Event as "An unexpected occurrence or variation which had the potential to result in serious injury."

Additionally, the policy stated, "Immediately upon being informed of the occurrence of the event, the Risk Manager or designee will initiate an assessment and the appropriate people will be contacted to conduct a root cause analysis. A root-cause (RCA) analysis will be conducted as soon as possible following event with the goal of no more than 30 days post event. A corrective action plan will be developed to eliminate or control system hazards or vulnerabilities directly related to causal and contributory factors. An implementation timeline will be completed timely, promoting systemic improvement, and appropriately reported to the respective committees and departments involved." This policy was not followed. An example includes:

Patient #21's medical record was obtained from the sending facility and reviewed. The medical record stated Patient #21 was an 80 year old female with a diagnosis of penetrating ulcer of aorta. She was transferred on 9/08/21 to the hospital's ED from the sending facility's ED for a surgical procedure.

An EMS report, dated 9/08/21, documented, "Once in ambulance bay at SJRMC, staff met M81 [ambulance] stating that surgeon did not have equipment necessary for surgery and so they could not accept pt [Patient #21]. Pt was to be returned to [transfer hospital] ED."

The hospital's ED log did not include an entry for Patient #21 on 9/08/21.

Surveyors requested Patient #21's medical record for services on 9/08/21. The Medical Records Department reported there was no record for Patient #21.

There was no documentation the hospital performed a medical screening examination of Patient #21.

The hospital's incident log was reviewed. The log did not include a report for Patient #21's incident on 9/08/21.

The hospital's Quality Improvement Director was interviewed on 3/30/22 at 11:03 am. When asked about the Patient #21's incident, she stated, "It should have been in our patient event system."

The hospital failed to identify and analyze Patient #21's incident.

Based on review of transfer center logs, policy, medical records, and nursing notes, and staff interview, it was determined the hospital failed to ensure all patients who presented to the ED for emergency medical care were treated in accordance with 42 CFR §489.24, Special responsibilities of Medicare hospitals in emergency cases. This failure impeded the hospital's ability to provide emergency care, and had the potential to affect all patients who presented to the ED with an emergency medical condition. Findings include:

1. A hospital policy titled "EMTALA - Central Log," reviewed 6/03/20, stated, "Each hospital must maintain a central log to identify each individual who either comes to the Dedicated Emergency Department seeking treatment for any medical condition or presents on Hospital Property or Premises seeking care for an emergency medical condition ... The log must contain:

- the name of the individual who comes to the emergency department seeking assistance; and
- whether the individual:
- refused treatment
- was refused treatment
- was transferred
- was admitted and treated
- was stabilized and transferred, or
- was discharged"

This policy was not followed. An example includes:

Patient #21's medical record was obtained from the sending facility and reviewed. The medical record stated Patient #21 was an 80 year old female who presented to the sending facility on 9/08/21 for a routine mammogram. Her record indicated she had a cardiac arrest during the mammogram and was transferred to the sending facility's ED. The ED note stated, "80-year-old female status post return of spontaneous circulation after cardiac arrest. Patient is noted to have a leaking aorta. I discussed patient [sic] [Physician Name] at St. Joseph and an interventional radiology graciously agreed to accept the patient in transfer patient will be transferred via [name] ambulance."

Patient #21's record from the sending facility also included a note from EMS, dated 9/08/21, which stated, "dispatched to [sending facility] ED for an emergent transfer to SJRMC cath lab [catheterization laboratory] with an 80 yof [year old female] who had a cardiac arrest during mammogram ...Pt slid to gurney, seat belted in and moved to ambulance. Vitals and assessment continued en route to SJRMC. Once in ambulance bay at SJRMC, staff met M81 stating that surgeon did not have equipment necessary for surgery and so they could not accept pt. Pt was to be returned to [sending facility] ED."

The transfer center notes regarding Patient #21 on 9/08/21 were reviewed. The notes stated, "Called to St Joseph's HS [hospital] ...Informed Dr [name] accepted to do procedure. Will go ed [emergency department] to ed."

The House Supervisor's daily note from 9/08/21 was reviewed. The note stated, "Had a call from the transfer center stating [sending facility] had a patient with a hole in her aorta that they coded and were wanting to talk to Dr. [name]. Informed them that we had no ICU beds but that they could still bring the patient for the procedure if Dr. [name] accepted. Dr. [name] accepted and was bringing that patient straight over to the cath lab. ER called about the patient and I informed them that [sending facility] would take the patient back after the procedure. Cath lab called and asked if we would have any bed and I informed them no. Shortly after the cath lab called ER and told them to stop the transfer because they didn't have the equipment for the procedure. At that time ER had the cath lab call [sending facility]. The patient had already left but when the ambulance arrived to our ER we had to have them turn around and take the patient back to [sending facility]. That is just a little messed up."

The ED log from 9/08/21 was reviewed. The log did not include Patient #21. Additionally, medical records for Patient #21 on 9/08/21 were requested, however no medical records for Patient #21 on 9/08/21 were provided.

The House Supervisor who was working on 9/08/21 was interviewed by phone on 3/30/22 at 4:47 PM. Her note from 9/08/21 was reviewed, and she confirmed the incident with Patient #21 sounded familiar to her. She stated, "I know they had just arrived when we found out that they didn't have the equipment ... in fact they met the ambulance out in the ambulance bay area ... and told them ... they would have to take the patient back," and, "I knew we couldn't keep the patient ... I know the lady was really critical."

The CNO was interviewed on 3/31/22 at 1:00 PM. She stated she was the CNO on 9/08/21. The transfer center log and the House Supervisor's notes from 9/08/21 were reviewed in her presence. When asked if it appeared, based on the documentation, that Patient #21 presented to the ED at SJRMC she stated, "yeah it does." When asked if Patient #21 was documented in the SJRMC ED log she stated, "not that I know of."

The hospital failed to ensure Patient #21 was documented in the ED log when she presented to the ED.

2. A hospital policy, "EMTALA - Medical Screening and Treatment of Emergency Medical Conditions," reviewed by the hospital 8/29/20, was reviewed.

The purpose of the policy was stated as, "To ensure that individuals coming to an affiliated Hospital's Dedicated Emergency Department seeking assessment or treatment for a medical condition, or coming to Hospital Property requesting ... treatment for an Emergency Medical Condition receive an appropriate Medical Screening Examination as required by the Emergency Medical Treatment and Labor Act (EMTALA), 42 U.S.C., Section 1395 and all Federal regulations and interpretive guidelines promulgated thereunder, and, if an Emergency Medical Condition is determined to exist, such individuals are offered stabilizing treatment within the Hospital's capabilities and/or are transferred if appropriate ..."

The policy included the definition, "Hospital Property or Premises means the entire Hospital campus, including the parking lot, sidewalk, driveway, and hospital departments ... "

The policy included the definition, "Medical Screening Examination is the process required to reach with reasonable clinical confidence, the point at which it can be determined whether or not an Emergency Medical Condition exists or a woman is in labor. Such screening must be done within the facility's capability and available personnel, including on-call physicians. The Medical Screening Examination must be performed by a Physician or other Qualified Medical Personnel."

Patient #21's medical record was obtained from the sending facility and reviewed. The medical record stated Patient #21 was an 80 year old female with a diagnosis of penetrating ulcer of aorta. She was transferred on 9/08/21 to the hospital's ED from the sending facility's ED for a surgical procedure.

Patient #21's EMTALA/Transfer Consent Form from the sending facility, dated 9/08/21, stated Patient #21 was accepted by the hospital's interventional radiologist at 9:53 AM, and the hospital's "Cath Lab RN" received the report.

Patient #21's ED notes received from the sending facility, dated 9/08/21, included the following RN notes:

10:07 AM - "Pt accepted by Dr. [name] at cath lab ... EMS here to transport pt at this time. Report given."
10:11 AM - "Report called to [RN] at cath lab"
10:34 AM - "[St. Joseph's] cath lab unable to take pt. Call to [another receiving facility] at this time."
11:41 AM - "Esmolol infusing at time of transfer ... Lifeflight here to transport pt to [another receiving facility]. Report given to them."

Patient #2's EMS report, dated 9/08/21, stated, "M81 [ambulance] dispatched to [transfer facility] for an emergent transfer to SJRMC cath lab with an 80 yof who had cardiac arrest during mammogram... Once in ambulance bay at SJRMC, staff met M81 stating that surgeon did not have equipment necessary for surgery and so they could not accept pt. Pt was to be returned to [sending facility] ED. Pt placed in room T1..."

The hospital's CNO was interviewed on 3/31/22 beginning at 1:00 PM and Patient #21's records were reviewed in her presence. When asked if it appeared that Patient #21 had an MSE upon arrival to the ED on 9/08/21, she replied, "I don't know that." When asked if she was aware of Patient #21's incident on the morning of 9/08/21, she replied "I was not, because I was not the AOC on call".

The hospital failed to perform a medical screening exam for patient #21 who presented to their ED.

The cumulative effects of these negative systemic practices impeded the ability of the hospital to meet the needs of emergency patients.