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Based on observations, interviews and record review, the Governing Body failed to determine, implement, and monitor patient safety and patient staffing issues in the emergency room, and held the ultimate responsibility for the hospital's compliance with the specific Condition of Participation (CoP) for the provision of services, when:

1. There was no comprehensive plan to address the inability of the facility to divert patients. (Cross Reference A-1112)

2. There was not enough emergency room staff to provide effective emergency care when patients were not assessed and monitored. (Cross Reference A-1112)

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality health care in a safe environment, and an inability to comply with the statutorily mandated Condition for Coverage for Governing Body.




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Based on interviews, and document review, the hospital failed to ensure a Quality Assurance Process Improvement (QAPI) which reflected the care and services provided to patients when:

1. A performance improvement plan to implement a licensed nurse in the Emergency Room waiting area was not implemented thoroughly, assessed, and monitored by the Quality Assessment Performance Improvement (QAPI) Committee to ensure staff understanding of the patient safety duties and responsibilities of the position. (Cross Reference A-1112)

2. The Emergency Room had no strategic plan for a patient surge during a staffing shortage. This failure to ensure staffing resulted in the waiting area Licensed Nurse being reassigned in the Emergency Room, leaving the patients in the Emergency Room waiting area unmonitored by Licensed Staff, and potentially contributed to the death of one patient (Sampled Patient 1). (Cross Reference A-1112)

The cumulative effect of this systemic problem resulted in the facility's inability to ensure the provision of quality health care in a safe environment in the Emergency Room, and an inability to comply with the statutorily mandated Condition of Participation for QAPI.



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Based on interviews, and document review, the hospital failed to ensure nursing services met patient needs and were provided following standards of practice as evidenced by its failures to implement its policies and procedures on ED patient re-assessment, restraints, and pain re-assessment (Cross Reference A-0398).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment, in accordance with the statutorily mandated Conditions of Participation for Nursing Services.





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Based on interview and record review, the facility did not follow policy and procedures for four of 33 sampled patients when:
1. Two ED patients (Patient 1 and 2) were not reassessed after triage and while awaiting care in the waiting area,
2. One patient (Patient 3) with physician orders for restraints, did not have any documentation for 11.5 hours, and
3. One patient's pain level was not reassessed after pain medication was administered (Patient 7).

These failures resulted in: 1. delayed the provision of medical screening examination (MSE) for Patients 1 and 2, and potentially caused Patient 1's emergency medical condition to worsen without monitoring or detection, resulting in his death, 2. increased risk of patient harm or death if restraints were not administered, monitored, and discontinued according to facility Policy and Procedure (P&P), and, 3. potential for unrelieved pain and suffering of patients.

Findings:

1. During a record review on 12/19/23 on 11:12 a.m., Patient 1's "ED Encounter" dated 12/8/23 was reviewed. Record review revealed the following timeline:
15:44 (3:44 p.m.): Patient 1 arrived (walked-in) to the ED with complaints of chest discomfort.
15:49 (3:49 p.m.): an EKG (or ECG, is a test that checks how the heart is functioning by measuring the electrical activity of the heart) was performed on Patient 1 and yielded a sinus rhythm result (normal).
15: 52 (3:52 p.m.): Patient 1's vital signs were checked: Blood pressure (BP) = 170/85, Heart Rate (HR) = 70, Resp (Respirations) = 16, SpO2 (oxygen saturation) = 100, Temp (Temperature) = 98.1. Patient 1 reported a pain score of 7 out of 10.
15:55 (3:55 p.m.): Patient 1 was triaged and identified as ESI Priority 2. [The Emergency Severity Index (ESI) is an emergency nursing association (ENA) and American College of Emergency Physicians (ACEP) approved triage system using a five-level triage scale where ESI level 1 is the highest severity. ESI Level 1 concerns the highest acuity patients requiring immediate, life-saving interventions without delay. ESI Level 2 is a patient with an illness or injuries that place them at high risk for deterioration, or signs of a time-critical problem that require prompt attention. ESI Level 3 is a patient with illnesses or injury that is stable but require prompt medical attention and require two or more resources. ESI Level 4 is a patient who has no medical emergency and has an illness or injury that requires one resource. ESI priority 5 is a patient who has no medical emergency and requires no resources, such as seeking care for a chronic or routine problem.]
16:11 (4:11 p.m.): Blood samples, including troponin (the biomarker of choice for detecting heart muscle damage) were obtained from Patient 1.
16:54 (4:54 p.m.): Patient 1's blood sample results indicated normal troponin levels.
17:29 (5:29 p.m.): Patient 1's vital signs were rechecked; BP = 126/78, HR = 72, Resp = 16, SpO2 = 95. Patient 1 reported a pain level of 10.
17:30 (5:30 p.m.): Patient 1 was sent back to the ED lobby and awaited room placement for an MSE.
23:30 (11:30 p.m.): Patient was roomed to TR14, asystole (no heartbeat) from triage, CPR (or cardiopulmonary resuscitation is an emergency technique used on someone whose heart or breathing has stopped) in progress. Official time of death was called at 23:59 (11:59 p.m.).

During a concurrent interview and record review on 12/19/23 at 11:35 a.m. with Director B, Patient 1's ED Encounter on 12/8/23 was reviewed. Director B confirmed there were no notes between Patient 1's vital signs at 5:29 p.m., and his CPR Notes at 11:30 p.m. When pointed about the six-hour span, Director B nodded and stated, "There was a gap." Director B stated Patient 1 was brought back out to the waiting room and was never assigned a physician.

During an interview on 12/20/23 at 3:08 p.m., RN C stated bed placement in the ED depended on the patient's ESI priority. RN C stated a patient with an ESI 2 level was urgent, but not critical, and was ideally roomed as soon as possible. RN C stated ANMs (Assistant Nurse Managers) were notified when room placement was needed. RN C stated ESI 2 patients were reassessed every two hours and have their vital signs retaken and monitored for any changes of condition. When asked how Patient 1 was not reassessed during a six-hour period, RN C stated she was "literally checking in patients one after another that night" and added it was the triage nurse or the "Nurse First" who did the patient reassessments. RN C stated, "There's usually another triage nurse and a Nurse First, but I think I was the only triage nurse that night."

During an interview on 12/21/23 at 3 p.m., ED Clerk F stated she recalled the night Patient 1 came in, accompanied by his family, for chest pain. ED Clerk F stated she put an "EKG Alert" on Patient 1, a protocol for every patient coming in with chest pain. ED Clerk F stated a nurse and tech came to evaluate Patient 1, then Patient 1 went back out to the waiting room. ED Clerk F stated sometime after, she saw fire trucks drive outside the building. ED Clerk F stated she got up and went to the lobby, found Patient 1 on a wheelchair with his family members, speaking with the fire emergency crew. ED Clerk F stated the family had called 911, and she heard the fire emergency crew tell Patient 1 that they could not do anything because he's inside the [hospital] facility. ED Clerk F stated she wheeled Patient 1 back to the EKG room and notified the nurse of Patient 1's continued pain. ED Clerk F stated she was not sure what happened to Patient 1 after. ED Clerk F stated the ED was "crazy busy" that night, with maybe 30 or 40 patients around, and added the waiting area was almost "standing room only". ED Clerk F stated she recalled seeing Patient 1 seated on a wheelchair, at the overflow hall with his family, later that night. When asked if anyone checks on the patients while they wait in the waiting room, ED Clerk F stated the Nurse First usually did, every two hours. ED Clerk F stated the Nurse First had left at 6 p.m. that evening.

During an interview on 12/22/23 at 11:30 a.m. RN G stated she was the "Nurse First" the evening of 12/8/23. When asked what her role was as "Nurse First," she stated you are at the front desk re-assessing patients (taking vital signs, and draw bloods for the lab, and room patients inside the ED) after they have been triaged until they are roomed for an MSE. RN G stated she only worked from 4:30 p.m. to 6:30 p.m. that evening, during that time the ED was extremely busy, and she was pulled to assist patients that were inside the ED to help with patient lab draws, and x-rays. RN G stated there was only one triage nurse on that evening and there was no "Nurse First" during the day shift or on the night shift after she left.

During an interview on 12/22/23 at 12:21 p.m., when asked what the expectation was if a patient was triaged with an "ESI of 2," ANM H stated her expectation was patient's received continuous care and reassessment and roomed as soon as possible. The role of the "Nurse First" was to ensure the patients' that had been triaged were re-assessed in the waiting room every 2 to 4-hours or as needed.

During a record review on 12/22/23 at 12:40 p.m., Patient 2's "ED records" dated 12/8/23 were reviewed. Record review revealed the following timeline:
15:06 (3:06 p.m.) Patient 2 was wheeled over to the ED from internal medicine department by wheelchair with complaints of "Shortness of Breath."
15:32 (3:32 p.m.) Patient 2 was triaged as an ESI-3- Urgent, Patient 2's vital signs were BP = 98/47, HR = 54, Resp = 20, SpO2 = 96%, Temp. 97.1F.
23:03 (11:03 p.m.) Patient 2's next set of vital signs were BP = 108/48, HR = 54, Resp = 18, SpO2 = 98%.
23:15 (11:15 p.m.) Diagnostic imaging (Head CT) was ordered for Patient 2, History and Physical notes indicated that Patient 2 was alert and oriented when arrived but seems to have become delirious.
12/9/23 01:51 (01:51 a.m.) Patient 1 was roomed.
12/9/23 03:24 (3:24 a.m.) an MSE was conducted by an MD.
12/9/23 06:17 (06:17 a.m.) Patient 2 was admitted to the ICU.

During the record review, the Medical Records Assistant M was asked to verify the assessments taken in the ED for Patient 2. The Medical Records Assistant M verified the only assessments/re-assessments conducted were upon admission and after 11:03 p.m.

During an interview on 1/5/23 at 10 a.m., ANM I stated the goal for ESI 2 patients was to get them roomed as quickly as possible. ANM 1 stated was aware Patient 1 was in the lobby, but he could not recall if he had specific notifications about Patient 1's ESI 2 Level. ANM I stated the ED was busy that day, and even had to triage several ESI 2 patients in the waiting room. ANM I stated there were "significant struggles" in the back as well, with multiple Team Stats (emergencies), stroke alerts, gunshot wound patients, mass transfusions and admission holds. ANM I stated the Nurse First would reassess the patients in the waiting room and check their vital signs every two hours. ANM I stated in the absence of the Nurse First, the second triage nurse would do the reassessments. ANM I stated the facility tries to keep all three nurses at the front, but the second triage nurse could have been pulled to the back or reassigned somewhere that night.

During an interview on 1/5/23 at 10:30 a.m., Physician A stated patients should have been reassessed while they were out in the waiting room and patients identified as ESI 2 should be reassessed every two hours. Physician A stated Patient 1 was neither reassessed nor had his vitals retaken and was not referred to a doctor when his pain escalated from 7 to 10. When asked if reassessments could have prevented Patient 1's demise, Physician A stated, "It would be hard to say if that could have helped." Physician A stated the expectation remained that reassessments should have been done per ED goals.

During an interview on 1/5/23 at 11:30 a.m., RN J stated he was the second triage nurse until 7:30 p.m. the evening Patient 1 came to the ED, then was "floating all over the place" helping with transporting patients and expediting discharges. RN J stated patients in the waiting room get reassessed, but as the ED was so busy, with patients waiting and coming in at the same time, patients waiting in the other hallway and some just leaving, it was "impossible" to get back to all of them.

During an interview on 1/5/23 at 3:01 p.m., ED Tech L stated recalling doing the EKG on Patient 1 the evening he came to the ED. ED Tech L stated Patient 1 was brought back out to the waiting room after the EKG. ED Tech L stated ED techs rechecked the vital signs of patients "sometimes", "as needed", or "when asked by the nurses". ED Tech L stated she could not recall any nurse requesting her to recheck Patient 1's vital signs that night.

During an interview on 1/5/23 at 3:18 p.m., Director B stated Patient 1 had no reassessments done after his vital signs were last checked. Director B stated triage nurses were expected to reassess patients while they were in the waiting area. Director B stated patient reassessment was important to catch emergencies, prevent any delay of care, and prevent such things [Patient 1's demise] from happening.

During a review of the facility's policy and procedure titled, "Basic Unit of Care Standards for the Emergency Department", dated "10/2022", indicated, "Patients with an EDI level of 1 will be directly roomed. ESI 2 will be roomed as soon as possible. If no room available, the triage registered nurse will communicate with the ANM prioritize availability. These patients will be rechecked a minimum of every 2 hours while waiting to be roomed. The recheck will include vital signs ..."

During a review of the facility's procedure titled, "Nurse First", no date, indicated, Primary Role of the Nurse First was to recognize and facilitate treatment of deteriorating patients in the lobby through subjective and objective observations and second to facilitate throughput of stable patients in lobby. "Nurse First Duty highlights," indicated, Be Present-As much as possible stay in the clerk box, Reassess- Complete every 2-hours, and take this time to update their status, back up triage if no RN2 is present.

2. During an interview on 1/8/24, at 11:15 a.m. RN M stated when a patient is a danger to themselves or others, restraints were applied, with a doctor's order. The Physician and nurse have to document why restraints are needed. She stated the patient had to have been observed at least every 15 minutes if the restraints were for violent behaviors. She stated monitoring occurred to be sure patient was safe, extremities were not having circulation issues related to restraints, or potential for choking themselves with the restraint device. She stated there had to be a physician's order to put on restraints and to take them off.

During an interview and record review on 1/8/24, at 12:30 p.m., Unlicensed Staff O stated the P&P for restraints was in a book at the nursing station. He stated patients in restraints require every 15-minute monitoring by either a staff or security guard to be sure the patient was safe. He stated patients had restraints to protect themselves and others who are trying to help them. He stated the risk of not monitoring patients in restraints was they could choke and not be able to sit up and clear their own airway or strangulate themselves if they tried to get out of bed while in restraints, and if no monitoring they potentially could die.

During an interview on 1/8/24, at 12:53 p.m., Unlicensed Staff P stated patients in restraints or on suicide prevention, were documented as being observed for safety every 15 minutes. He stated restraint observation and documentation was part of keeping patients safe because patients in restraints had a risk from hurting themselves from choking or strangulation.

During a concurrent interview and record review on 1/9/24, at 11 a.m., Unlicensed Staff S stated restraint audits are completed for all emergency room patients to determine compliance with Restraint P&P. She stated it was a patient safety quality issue that was being monitored by the facility.

During a concurrent interview and record review on 1/9/24 at 11:20 a.m., with RN R, the Electronic Medical Record (EMR) for Patient 3, indicated he was admitted to the emergency room (ER) 11/29/23 at 5:15 p.m. for confusion after pulling out his urinary catheter (A soft, flexible drainage tube into the bladder through the opening where urine comes out of the body. It is secured in the bladder by inflation of a small balloon on the tip of the catheter.), at home, after a surgical procedure. RN R stated for Patient 3 on 11/30/23 at 12:47 a.m., there was a physician order for soft restraints to both wrists and a vest on 11/30/23 at 12:47 a.m. the order indicated "Clinical Reason PULL OUT LINES?DRESSINGS INTERFERING WITH MEDICAL TREATMENT." A review of a document titled All Flowsheet Data (11/29/23 0000(midnight) - 12/01/23 2359 (11:59 p.m.), indicated restraint monitoring occurred every 15 minutes from 11/30/23 at 12:50 a.m. to 11/30/23 at 2:36 a.m. Unlicensed Staff S stated the monitoring occurred every 15 minutes, according to the facility P&P for restraints. RN R stated Patient 3 was transferred to the fourth floor 11/30/23 at 2:36 a.m. and there was no restraint documentation after transfer to the floor. RN R stated there were no discontinuation orders for the restraints after the patient was transferred up to the floor. Director T stated if an ER patient on restraints was admitted to the hospital and transferred to the floor there should have been documentation about the patient's restraints.

During a concurrent record review and interview, on 1/9/24, at 2:37 p.m., RN N reviewed the fourth-floor documentation for Patient 3, and stated there was no restraint documentation after the patient was transferred to the floor. He stated if the patient was restrained there should have been a physician order for restraints, or a nursing note and he could not find documentation about restraints once the patient was transferred to the fourth floor. RN N stated Patient 3 was discharged from the hospital 11/30/23 at 2:07 p.m. Review of a document titled "Discharge Summary Hospital Course and Significant Findings:" dated 12/1/23 at 8:24 p.m., it indicated " Brought to hospital in late evening after became more agitated, Seroquel 50 and Haldol 3 mg given in ER and required restraints. Currently patient is alert oriented time 1, trying to get up and pulling his restraints." RN Q, RN R, Director T did not provide statement or documents to indicate the restraint order had been discontinued or the restraints had been removed at any time, up to and including discharge home. They did not respond when asked if the facility followed the P&P for Restraints. RN N stated he could not find restraint assessment, restraint monitoring notes, care plan for restraints, or discontinue orders in the EMR for Patient 3. He stated for 11 hours and 30 minutes, there was no restraint documentation. RN N stated the facility P&P for restraints was not followed and the risk to the patient was harm or potential death from choking, airway blocked or strangulation.

During a concurrent record review and interview with RN W, 1/10/24, at 1;05 p.m., she reviewed Patient 3 EMR and stated she could not find any physician orders for restraints or any documentation that the restraints were monitored according to facility P&P. She stated if the restraints were discontinued the EMR should have a physician's discontinue restraints order. She stated the restraint policy stated if restraints are removed, there should be documentation the patient's condition had changed and been assessed to reflect the removal of the restraints. She stated it appeared the EMR did not indicate the facility P&P for restraints was followed. She stated the risk of not following the P&P for restraints was the potential for harm or death to the patient.

A review of a facility P&P titled "Restraints NCAL Regional Policy," reviewed 11/5/2020, indicated "Each episode of restraint use must be initiated in accordance with the order of an MD /LIP. Staff cannot discontinue restraints and restart without obtaining a new physician order." " Discontinuation of restraints the patient should be assessed to determine the patient's condition and whether restraint can be discontinued. The physician or nurse responsible for the patient's care has the authority to discontinue restraints based on patient assessment. The decision to discontinue the restraint should be based on the determination that the patient is no longer a threat to themselves or others (i.e., no longer exhibiting violent, or self-destructive behavior), the unsafe situation no longer exists, or the patient's safety can be maintained, and care needs met with less restrictive methods."

A review of a document titled "(Lippincott) Restraint application, limb" reviewed: February 20, 2023, indicated "Documentation associated with limb restraint application includes: ...conditions or behaviors necessary for discontinuing the restraints."

A review of a document titled "Order," dated 11/30/23 at 12:47 a.m. indicated "RESTRAINTS FOR NON-VIOLENT BEHAVIOR Restraint placement location(s)? Both Wrists; Clinical reason for restraints? PULL OUT LINES/DRESSINGS, INTERFERING WITH MEDICAL TREATMENT ..."

A review of a document titled "ED Provider Notes," dated 11/29/23, at 5:17 p.m., indicated "Chief Complaint: Patient presents with FOLEY PROBLEM PATIENT HAD PART OF PROSTRATE (A gland located just below the bladder in men and surrounds the top portion of the tube that drains urine from the bladder.) REMOVED THIS MORNING , WENT HOME PULLED FOLEY OUT HERE NOW FOR REPLACEMENT." "Care Timeline 11/29 1717 (5:17 p.m.) arrived ...11/30/23 0156(1:56 a.m.) Placed in Observation 11/30/23 0237 (2:37 a.m.) Transferred to 4WT (fourth floor nursing unit).



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3. During a concurrent observation and interview on 1/9/24 at 11:39 a.m., Patient 7 stated he just had surgery and reported pain. Patient 7 pushed his call light and RN U came into the room. RN U reminded Patient 7 that she had just given him morphine a few minutes ago. RN U stated the patient's pain level was to be rechecked 30-60 minutes after pain medication was provided, and offered to call the physician if the pain was unrelieved.

During a concurrent record review and interview on 1/10/24 at 2:30 p.m. with Manager V, Patient 7's medical records were reviewed. Patient 1's "Pain Management Flowsheet", dated "1/10/24", indicated, "0929 (9:29 a.m.): Pain Score = 7 (out of 10) ... Acceptable Level (Pain) = 4 ... Location = Abdomen ... Character = Sharp; Cramping ... Duration = Intermittent ... Aggravating Factors = Unknown ... Alleviating Factors = Medication ... Pain Intervention = Medication." A review of Patient 7's "Medication Administration Report", dated "1/10/24", indicated he received 2 mg (milligrams) of morphine (a pain medication) intravenously (IV, through the veins) at 9:29 a.m. Manager V stated a patient's pain level was supposed to be reassessed 30 minutes after an IV pain medication was given, or 60 minutes after for oral pain medications. Manager V stated there was no documented reassessment of Patient 7's pain level after the morphine was administered. Manager V stated there should have been a pain reassessment after Patient 7 was given the pain medication.

During an interview on 1/10/24 at 3:55 p.m., Manager V stated pain assessment was important as the goal of pain control was to keep the patients' pain at a level that was acceptable enough for them to continue to do ADLs (Activities of Daily Living, such as eating, hygiene and mobility) and other activities for their recovery. Manager V stated pain assessment was also an opportunity for the nurse to reach out to the physicians if the pain medications were ineffective.

A review of the facility policy titled, "Medication Administration Owner Patient Care Services", dated, "09/2021", indicated, "6.6.3. Monitor and document patient response to medications when required (e.g., when administering pain medication, antiemetics, or antipyretics ..."

A review of the facility policy titled, "BASIC UNIT CARE STANDARDS (BUCS), Med/Surg Units", dated "7/22", indicated, "A registered nurse (RN) will provide a timely patient assessment, reassessment and individualized plan of care based on the Guiding Principles, regulatory requirements and patient's condition. Assessments and re-assessment of the patient will be done according to unit standard ... Assessment of patient's pain/comfort level on admission, every shift, as needed, and within one hour of intervention ..."

Based on observations, interviews, and record reviews, the hospital failed to ensure the Emergency Services functioned effectively to meet the emergency needs of patients in accordance with acceptable standards of practice and facility policy and procedures as evidenced by its failure to maintain adequate staff to monitor two of 19 sampled walk-in patients (Patient 1 and Patient 2) who had been triaged but awaited room placement in the ED lobby, without timely re-assessments and emergency medical screening exams, resulting in the death of Patient 1 and a decline in Patient 2's mental status. (Cross Reference A-1112).

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality health care in a safe environment.



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Based on staff interviews, Emergency Department's (ED) policy and procedures, and ED patient record reviews, the facility failed to provide adequate staff to reassess walk-in patients who had been triaged but awaited room placement in the ED and ensure timely triage and emergency medical screening for two of 19 sampled patients (Patient 1 and Patient 2).

These failures did not comply with facility policy and delayed the provision of medical screening examination (MSE), and potentially caused Patient 1's emergency medical condition to worsen without monitoring or detection, resulting in his death eight hours after arrival to the ED.

Findings:

During an interview on 12/18/23 at 2:34 p.m., Confidential Complainant (CC) stated a patient (Patient 1) expired in the ED without being seen by a physician. CC stated the ED was understaffed, and there were 30-40 patients waiting in the ED at the time.

During a record review on 12/19/23 on 11:12 a.m., Patient 1's "ED Encounter" dated 12/8/23 was reviewed. Record review revealed the following timeline:
a. 15:44 (3:44 p.m.): Patient 1 arrived (walked-in) to the ED with complaints of chest discomfort.
b. 15:49 (3:49 p.m.): an EKG (or ECG, is a test that checks how the heart is functioning by measuring the electrical activity of the heart) was performed on Patient 1 and yielded a sinus rhythm result (normal).
c. 15: 52 (3:52 p.m.): Patient 1's vital signs were checked: Blood pressure (BP) = 170/85, Heart Rate (HR) = 70, Resp (Respirations) = 16, SpO2 (oxygen saturation) = 100, Temp (Temperature) = 98.1. Patient 1 reported a pain score of 7 out of 10.
d. 5:55 (3:55 p.m.): Patient 1 was triaged and identified as ESI Priority 2. [The Emergency Severity Index (ESI) is an emergency nursing association (ENA) and American College of Emergency Physicians (ACEP) approved triage system using a five-level triage scale where ESI level 1 is the highest severity. ESI Level 1 concerns the highest acuity patients requiring immediate, life-saving interventions without delay. ESI Level 2 is a patient with an illness or injuries that place them at high risk for deterioration, or signs of a time-critical problem that require prompt attention. ESI Level 3 is a patient with illnesses or injury that is stable but require prompt medical attention and require two or more resources. ESI Level 4 is a patient who has no medical emergency and has an illness or injury that requires one resource. ESI priority 5 is a patient who has novmedical emergency and requires no resources, such as seeking care for a chronic or routine problem.]
e. 16:11 (4:11 p.m.): Blood samples, including troponin (the biomarker of choice for detecting heart muscle damage) were obtained from Patient 1.
f. 16:54 (4:54 p.m.): Patient 1's blood sample results indicated normal troponin levels.
g. 17:29 (5:29 p.m.): Patient 1's vital signs were rechecked; BP = 126/78, HR = 72, Resp = 16, SpO2 = 95. Patient 1 reported a pain level of 10.
h. 17:30 (5:30 p.m.): Patient 1 was sent back to the ED lobby and awaited room placement for an MSE.
i. 23:30 (11:30 p.m.): Patient was roomed to TR14, asystole (no heartbeat) from triage, CPR (or cardiopulmonary resuscitation is an emergency technique used on someone whose heart or breathing has stopped) in progress. Official time of death was called at 23:59 (11:59 p.m.).

During a concurrent interview and record review on 12/19/23 at 11:35 a.m. with Director B, Patient 1's ED Encounter on 12/8/23 was reviewed. Director B confirmed there were no notes between Patient 1's vital signs at 5:29 p.m., and his CPR Notes at 11:30 p.m. When pointed about the six-hour span, Director B nodded and stated, "There was a gap." Director B stated Patient 1 was brought back out to the waiting room and was never assigned a physician.

During an interview on 12/19/23 at 11:55 a.m., Director B stated the ED has 52 beds and staffing ratio was 1:4 (one nurse to four patients), with the ratio being lower for critical patients. Director B stated staffing ratios were met in the ED rooms, but with the higher census (number of patients) and acuity in the ED [waiting room], they "needed more help."

During a concurrent interview and record review on 12/19/23 at 1:20 p.m., the "DAILY ASSIGNMENT PM SHIFT" dated "12/8/23" was reviewed with Director B. Review of a document provided by the facility indicated, "ED Census 12/8/23 @ (at) 0600: 25 ... ED Census 12/8/23 @ 2122 (9: 22 p.m.): 69..."

During an interview on 12/20/23 at 3:08 p.m., RN C stated after a patient was checked in by the ED Clerk, the triage nurse would take the patient into the triage room for vital signs and ask them why they are here, take their history. RN C stated based on that information, the triage nurse would determine the patient's ESI level. RN C stated bed placement in the ED depended on the patient's ESI priority. RN C stated a patient with an ESI 2 level was urgent, but not critical, and was ideally roomed as soon as possible. RN C stated the ED was "very busy with a lot of patients" the night Patient 1 came in. RN C stated ESI 2 patients were reassessed every two hours and have their vital signs retaken and monitored for any changes of condition. RN C stated it was the triage nurse or the Nurse First who did the patient reassessments, but the ED did not always have a Nurse First. RN C stated, "There's usually another triage nurse and a Nurse First, but I think I was the only triage nurse that night." When asked how Patient 1 was not reassessed during a six-hour period, RN C stated they were "very short-staffed that night", and she was literally checking in patients one after another.

During an interview on 12/21/23 at 1:38 p.m., RN D stated a "Nurse First" was a licensed nurse assigned to sit in the waiting room to see over the patients who have been triaged, and constantly observe for any changes among the patients. RN D stated part of the Nurse First role was to do additional assessments such as vital signs, start order protocols, answer patient questions, and explain what is going on to the patients. RN D stated patient reassessments in the waiting room were done at least every two hours. RN D stated that in the absence of a Nurse First, the triage nurse would do the patient reassessments.

During an interview on 12/21/23 at 2:21 p.m., RN E stated patients in the ED go through triage and get roomed depending on their level of severity, while some would have to wait for beds. RN E stated there is a nurse that recheck the patients' vital signs while they wait for beds. RN E stated ESI Level 2 patients could be "heavy" and need to be roomed as quickly as possible.

During an interview on 12/21/23 at 3 p.m., ED Clerk F stated she recalled the evening Patient 1 came to the ED. ED Clerk F stated Patient 1 came in, accompanied by his family, for chest pain. ED Clerk F stated she asked Patient 1 for some history, and Patient 1 denied any history of heart attacks or surgeries. ED Clerk F stated she put an "EKG Alert" on Patient 1, a protocol for every patient coming in with chest pain. ED Clerk F stated a nurse and tech came to evaluate Patient 1, then Patient 1 went back out to the waiting room. ED Clerk F stated sometime after, she saw fire trucks drive outside the building. ED Clerk F stated she got up and went to the lobby, found Patient 1 on a wheelchair with his family members, speaking with the fire emergency crew. ED Clerk F stated the family had called 911, and she heard the fire emergency crew tell Patient 1 that they could not do anything because he's inside the [hospital] facility. ED Clerk F stated she wheeled Patient 1 back to the EKG room and notified the nurse of Patient 1's continued pain. ED Clerk F stated she was not sure what happened to Patient 1 after. ED Clerk F stated the ED was "crazy busy" that night, with maybe 30 or 40 patients around, and added the waiting area was almost "standing room only". ED Clerk F stated she recalled seeing Patient 1 seated on a wheelchair, at the overflow hall with his family, later that night. ED Clerk F stated it was around the end of her shift at 11:30 p.m. when nurses responded to an overhead page about an emergency in the ED lobby. When asked if anyone checks on the patients while they wait in the waiting room, ED Clerk F stated the Nurse First usually did, every two hours. ED Clerk F stated the Nurse First had left at 6 p.m. that evening.


During an interview on 1/5/24 at 10 a.m., ANM stated he had been the ED ANM for about 11 years at the facility. ANM I stated parts of his responsibility as an ANM were to guide the movement and flow of the patients coming in from triage to the physician or a room or a nurse and monitor the ED as a whole. ANM I stated he worked until 7 p.m. the evening Patient 1 came to the ED. ANM I stated the goal for ESI 2 patients was to get them roomed as quickly as possible. ANM 1 stated was aware Patient 1 was in the lobby, but he could not recall if he had specific notifications about Patient 1's ESI 2 Level. ANM I stated the ED was busy that day, and even had to triage several ESI 2 patients in the waiting room. ANM I stated there were "significant struggles" in the back as well, with multiple Team Stats (emergencies), stroke alerts, gunshot wound patients, mass transfusions and admission holds. ANM I stated the Nurse First would reassess the patients in the waiting room and check their vital signs every two hours. ANM I stated in the absence of the Nurse First, the second triage nurse would do the reassessments. ANM I stated the facility tries to keep all three nurses at the front, but the second triage nurse could have been pulled to the back or reassigned somewhere that night.

During an interview on 1/5/23 at 10:30 a.m., Physician A stated patients should have been reassessed while they were out in the waiting room and patients identified as ESI 2 should be reassessed every two hours. Physician A stated Patient 1 was neither reassessed nor had his vitals retaken and was not referred to a doctor when his pain escalated from 7 to 10. When asked if reassessments could have prevented Patient 1's demise, Physician A stated, "It would be hard to say if that could have helped." Physician A stated the expectation remained that reassessments should have been done per ED goals.

During an interview on 1/5/24 at 11:30 a.m., RN J stated his shift was supposed to end at 7:30 p.m. the night Patient 1 came to the ED but stayed until 10:30 p.m. because "he knew they (ED) needed help." RN J stated he was the second triage nurse until 7:30 p.m., then was "floating all over the place" helping with transporting patients and expediting discharges. RN J stated the roles of the second triage nurse included helping with second triage, keeping eyes on the next patient, making sure orders were done, and catching up with the triage nurse in the front. RN J stated it was "so busy" that night with a gunshot wound, two strokes, an overdose, and a massive transfusion protocol in the ED. RN J stated patients in the waiting room get reassessed, but as the ED was so busy with patients waiting and coming in at the same time, patients waiting in the other hallway and some just leaving, it was impossible to get back to all of them.

During an interview on 1/5/23 at 3:01 p.m., ED Tech L stated recalling doing the EKG on Patient 1 the evening he came to the ED. ED Tech L stated Patient 1 was brought back out to the waiting room after the EKG. ED Tech L stated ED techs recheck the vital signs of patients "sometimes" or "as needed" or "when asked by the nurses." ED Tech L stated she could not recall any nurse requesting her to recheck Patient 1's vital signs that night.

During an interview on 1/5/23 at 3:18 p.m., Director B stated Patient 1 had no reassessments done after his vital signs were last checked. Director B stated there was no Nurse First at the time and the triage nurses were expected to reassess the patients in the waiting area in the absence of a Nurse First. Director B stated patient reassessment was important to catch emergencies, prevent any delay of care, and prevent such things [Patient 1's demise] from happening.


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During an interview on 12/22/23 at 11:30 a.m. RN G stated she was "Nurse First" the evening of 12/8/23. When asked what her role was as "Nurse First," she stated you are at the front desk re-assessing patients (taking vital signs, and draw bloods for the lab, and room patients inside the ED) after they have been triaged until they are roomed for an MSE. RN G stated she only worked from 4:30 p.m. to 6:30 p.m. that evening, during that time the ED was extremely busy, and she was pulled to assist patients that were inside the ED helped with patient lab draws, and x-rays. RN G stated there was only one triage nurse on that evening and there was no "Nurse First" during the day shift or on the night shift after she left. RN G was asked if she felt comfortable asking the charge nurse for additional staff to help. RN G stated she did request additional help from the nurse manager, but there was not enough staff that evening.

During an interview on 12/22/23 at 12:21 p.m., ANM H was asked if she remembered the events of the evening of 12/8/23. ANM H stated she had left before the incident occurred, but remembered the ED was extremely busy that evening with long wait times. When asked if the triage nurse spoke with her about finding a room for Patient 1, ANM H stated she did not remember speaking with the triage nurse about Patient 1. When asked what the expectation was if a patient was triaged with an "ESI of 2," ANM H stated her expectation was patient's received continuous care and reassessment and roomed as soon as possible. The role of the "Nurse First" was to ensure the patients' that had been triaged were re-assessed in the waiting room every 2 to 4-hours or as needed. The first nurse helped expedite the medical orders and recommended a patient to be roomed. When asked if ANM H asked for additional help for the ED that evening, ANM H stated she did ask for additional help, but there wasn't any available staff.

During a record review on 12/22/23 at 12:40 p.m., Patient 2's "ED records" dated 12/8/23 were reviewed. Record review revealed the following timeline:
a. 15:06 (3:06 p.m.) Patient 2 was wheeled over to the ED from internal medicine department by wheelchair with complaints of "Shortness of Breath."
b. 15:32 (3:32 p.m.) Patient 2 was triaged as an ESI-3- Urgent, Patient 2's vital signs were BP = 98/47, HR = 54, Resp = 20, SpO2 = 96%, Temp. 97.1F.
c. 23:03 (11:03 p.m.) Patient 2's next set of vital signs were BP = 108/48, HR = 54, Resp = 18, SpO2 = 98%.
d. 23:15 (11:15 p.m.) Diagnostic imaging (Head CT) was ordered for Patient 2, History and Physical notes indicated that Patient 2 was alert and oriented when arrived but seems to have become delirious.
e. 12/9/23 01:51 (01:51 a.m.) Patient 1 was roomed.
f. 12/9/23 03:24 (3:24 a.m.) an MSE was conducted by an MD.
g. 12/9/23 06:17 (06:17 a.m.) Patient 2 was admitted to the ICU.

During the record review, the Medical Records Assistant M was asked to verify the assessments taken in the ED for Patient 2. The Medical Records Assistant M verified the only assessments/re-assessments conducted were upon admission and after 11:03 p.m.


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During an interview in the Emergency Room on 1//8/24, at 11 a.m., Emergency Room Director B stated the role of a nurse in the Emergency Room waiting area was to assess patients, perform clinical interventions if necessary and patient safety. She stated the licensed nurse position was titled Nurse First position and was supposed to provide 24/7 nursing judgement at the point of contact with patients. She stated the Emergency Room piloted the Nurse First position February 2023, in response to the staff concerns related to patient safety and staffing.

During an interview on 1/8/24, at 11:15 a.m., in the emergency room hallway, Physician A stated, "Issues in the ER are staffing, concerns when short staffed and when nursing is out of ratio." He stated the emergency department prioritized patient care and to move patients either into the emergency room for evaluation and then up to the floor for care, or discharge patients with follow up instructions." He stated if the hospital could not move patients up to the floor, patients who need to be admitted to the hospital wait in the emergency room. He stated if the emergency room is full of patients who were waiting to be transferred up to the floor, then patients in the reception area would have to wait for longer and longer times to be evaluated. Physician A stated if nursing was short staffed, and the emergency room was full, then "Bad things could happen."

During the interview on 1/8/24, at 11:15 a.m., Physician A stated there was an "incident in December." He stated a patient had come into the waiting area of the Emergency Room on a busy night and complained of chest pain. Physician A stated the nurse that was supposed to be in the waiting room to monitor patients was not present. He stated the patient continued to complain of chest pain, but there were no available spaces in the Emergency Room, so he had to wait in the waiting room where the patient experienced a heart attack and expired. He stated there was a surge of patients, nursing was short staffed, and we were extremely busy, and we could not divert ( When a hospital and its emergency room are overloaded to the point that they can no longer safely accommodate another patient. The hospital will declare itself on a 'diversion' status, meaning that they cannot accept new ambulance arrivals until they can recover to what they deem is a safer time.) patients. Physician A stated the facility evaluated the incident and concluded that low staffing, escalation of issues did not happen, and that resulted in the patient's death.

During an interview on 1/8/24, at 12:30 p.m., Unlicensed Staff O stated the Emergency Room staffing is not consistent. He stated "Usually something bad happens then we get a flood of staffing and then over time staffing gets low." He stated management tried to cut back so staffing always went up or down. He stated lack of staffing contributed to strain at work, staff fatigue and risk to patient safety. He stated he was aware of the patient death in December. Unlicensed Staff O stated "We could have done better as a department. Staffing was a problem that night and were swamped." He stated the patient was checked into the waiting are and should have been reassessed every two hours, but it was not done. He stated if the patient had chest pain he should have been immediately assessed by a nurse and physician. He stated "There wasn't enough staff, and we were full. We couldn't move patients out to floor because they were full too." He stated on the night of the incident patients were waiting eight to nine hours to be seen.

During an interview with the Physician Quality Leader and the Medical Executive Chair, on 1/9/24 at 1 p.m., they stated the Quality Policies and Procedures and the annual Quality Plan were approved by the Governing Body. They stated the Quality Committee is combined with the Medical Executive Committee. They stated the committee ensures oversight on any facility system that needs improvement. They stated they determine priorities for the Quality Program by reviewing high risk, high volume and problem prone events, and reducing patient harm event. When asked what performance improvement projects were currently being monitored, they were unsure and stated they would have to review the QAPI (Quality Assurance/ Performance Improvement) minutes. During the interview they did not indicate an Emergency Room patient safety issue or nurse staffing shortages and long wait times.


During a concurrent interview on 1/10/24, at 1:30 p.m., Chief of Medicine stated the Governing Body heard about the incident and it was a tragic set of circumstance. He stated the facility was not permitted to divert, even if we have no patient beds. He stated the plan for patient care included working with supervisors, managers to keep patients moving from the Emergency Room to the floor or stabilize them and send them home. Chief of Medicine stated if a patient was in ER and complained of chest pain, he should have been seen immediately. He stated the patient was not monitored because there was no licensed nurse in the lobby because the Emergency Room was full, and the waiting room nurse had been pulled into the Emergency Room to help because the department was short staffed. CEO stated he had heard about the incident, and it was tragic set of circumstances. He stated staffing had never been an issue. He stated he spoke with staff and usually the complaints of short staffing were from a bad night they experienced. He stated the facility cannot shut down the Emergency Room if there were no beds available. CEO stated the facility strategy to keep treating emergency room patients was to work with supervisors, managers and send emergency room patients to the floor if possible.


A review of the facility's policy and procedure titled, "Basic Unit of Care Standards for the Emergency Department", dated "10/2022", indicated, "ESI 2 will be roomed as soon as possible. If no room available, the triage registered nurse will communicate with the ANM prioritize availability. These patients will be rechecked a minimum of every 2 hours while waiting to be roomed. The recheck will include vital signs..." "This policy defines the standards of care for all patients in the Emergency Department (ED) ... All patients will receive care that is safety focused, minimizing risk , and preventing harm."

During a review of an undated facility procedure titled, "Nurse First", indicated, "Primary Role of the Nurse First was to recognize and facilitate treatment of deteriorating patients in the lobby through subjective and objective observations and second to facilitate throughput of stable patients in lobby. "Nurse First Duty highlights," indicated, "Be Present-As much as possible stay in the clerk box, Reassess- Complete every 2-hours, and take this time to update their status, back up triage if no RN2 is present."

A review of an undated facility policy titled, "2023 Plan for Provision of Patient Care" indicated, "VI. Staffing: Staffing needs are assessed continuously and are based on operational need. The type and number of procedures performed determine assignment of patient care. The assignment is made by the manager or designee and reflects the degree of complexity of the procedure, the awareness of our patient population, the degree of supervision needed by the assigned individual and the technology used. Staffing is adjusted based on the above parameters."

Review of a facility document titled "2023 Plan for Provision of Patient Care," dated November 23, 2022, indicated "Unit Name: Emergency Department ...The department is responsible for the immediate evaluation of any medical or surgery emergency, for initiating life-saving procedures in all types of emergency situations and for providing emergency services." " Methods Used to Assess and Meet Patient Care Needs: Quality Improvement is an ongoing performance program in the Emergency Department." "These plans are designed to measure and assess the performance of the staff and thus improving the outcome of a patient care Quality indicators are based on the Emergency Department's degree of service with consideration to high volume, high risk and problem prone activities. The ED reports quarterly to the Medical Executive Committee the activities of the previous quarter. Several other resources used to determine the focus of the ED quality program include: patient satisfaction surveys, unusual occurrence reports, staff suggestions, patient care outcomes, case review, ... quality improvement plan evaluations and program findings."

Review of a facility document titled "THE RULES AND REGULATIONS OF THE PROFESSIONAL STAFF," dated 2023, indicated "ATTENDANCE OF PATIENTS IN EMERGENCY SITUATIONS,"An appropriate medical screening examination within the capability of the hospital (including ancillary services) shall be provided to all individuals who come to the emergency department or labor and delivery and request (for on whose behalf a request is made) examination or treatment. ...Emergency services and care shall be provided to any person in danger of loss of life or serious injury or illness whenever there are appropriate facility and qualified personnel available to provider such services or care."

Review of a facility document titled "2023 Quality Improvement Plan / ED Triage Process," indicated "Quality Improvement Plan Goal Name: Improve Safety of Patients in Emergency Department Waiting Room." "Process Measure(s) Development of nursing process for safe management of patient reassessment in ED waiting Room. Goal Nov 1, 2023 Goal met. Developed the Nurse First Program in March 2023 that includes nursing reassessment requirements, recognize change in patient status, facilitation throughput, and escalation process." Further review indicated the facility did not meet a goal to decrease ED waiting room length of Stay (LOS) in ED waiting room >20%. The document indicated "In Progress: After implementation of Nurse First program: Avg Length of Stay (LOS) in waiting room: March-Sept 2023: Decreased16%." There was no indication that the Quality document included a surge plan or community need was reviewed or updated for 2023.