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Based on interview and record review, the hospital failed to provide medical examination and treatment to stabilize the emergency medical condition (EMC) for 2 of 18 patients, Patient (Pt) 5, and Pt 6, when:

1. Pt 5 came to the ED by ambulance on 3/24/24 with a chief complaint of allergic reaction to shrimp. Pt 5 was given epinephrine IM and oral Benadryl by family at home and given another dose of Benadryl in the ambulance due to wheezing. In ED Pt 5 was initially given steroids, an H2 blocker (antihistamine), and intravenous (IV) fluids and then 45 minutes after arrival Pt 5 began wheezing again and required another dose of epinephrine IM, and an inhaled dose of epinephrine (racemic). Pt 5 was discharged two and one-half hours after arrival and was not evaluated to determine the need for additional medical support. The physician did not consider the risk of rebound anaphylaxis prior to discharge.

This failure resulted in Pt 5 experiencing chest pain and shortness of breath at home, becoming unresponsive the next day, returning to the hospital and being admitted.

2. Pt 6 came to the ED on 4/17/24 at 9:45 p.m. with complaints of severe pain and a non-functional nephrostomy tube (a tube inserted through the skin into the kidney to allow urine to drain) following replacement earlier that day. The patient reported a pain level of 9/10, was triaged as an ESI 2 and sent to the lobby to wait. The MSE was initiated and a difference in the appearance of the hub (connector) on the nephrostomy tubes between the right and the left was noted by the Nurse Practitioner (NP) during the exam. Labs and a CT scan were ordered at 10:45 p.m. and the physician saw the patient on 4/18/24 at 12:03 a.m., over two hours from the time first arrived in the ED. Pt 6 remained in the lobby for over five and a half hours, did not have vital signs reassessed, and was not provided fluids or pain medication. By 3:16 a.m. the CT scan still had not been done and Pt 6 could not wait any longer and left.

These failures resulted in not stabilizing and treating extreme pain level, in delay in diagnosing a retained stylet in the nephrostomy tube from the procedure on 4/17/24, an unnecessary hospitalization on 4/18/24, and a delay in removal of the stylet two days later on 4/19/24.

Findings:

1. During a record review the hospital's report of returns to ED within 48 hours (of a previous ED visit) was reviewed. The report indicated Pt 5 was a 25 year-old woman who came to the ED by ambulance on 3/24/24 at 9:57 p.m. with a chief complaint of allergic reaction and had returned to the ED by ambulance on 3/25/24 at 7:10 p.m. with a chief complaint of altered mental status.

During a record review on 5/14/24 at 10:20 a.m. with the ED manager (EDM), Pt 5's medical record dated 3/24/24 at 9:57 p.m. was reviewed. Review of the triage nurses notes dated 3/24/24 at 10:06 p.m. indicated, "Reason for Visit: Hx [history] of shrimp allergy. Ate shrimp today, family gave epi [epinephrine- medication given to treat severe allergic reactions] pen at home and gave oral Benadryl [an antihistamine medication given for allergy symptoms] for rash, Emergency Medical Services [EMS- service that responds to emergencies and provides pre-hospital medical care] gave 50 mg of Benadryl intramuscularly [IM]. Hx of depression, anxiety, Attention Deficit Hyperactive Disorder [ADHD], Post traumatic Stress Disorder [PTSD, seizure disorder." Vital signs were temperature 98.5 degrees Fahrenheit (F), pulse 113 beats per minute (bpm- normal 60-100), respirations 18 respirations per minute (rpm), blood pressure 165/97 millimeters of mercury (mmHg). Assigned an ESI of 2. Review of the ED Physician Note indicated the MSE was started at 10:07 p.m. The note indicated, "History of Present Illness: Apparently she is allergic to shrimp and ate something she did not know had shrimp in it. She started having facial swelling, and redness and shortness of breath...family members gave her some oral Benadryl and her Epi pen but did not feel like it was improving. EMS arrived and she was fairly tachypneic and wheezing throughout all lung fields. She was given a shot of IM Benadryl as well by EMS...They state that she steadily improved on the way here. She is now fairly somnolent [sleepy] with all of the Benadryl she received. Entirety of history obtained from EMS as patient is too somnolent to answer questions..."

Review of the medication administration record (MAR) indicated at 10:15 p.m. an intravenous (IV-into a vein) fluid bolus was started, and Pt 5 received a dose of IV steroids and IV Pepcid (a kind of antihistamine [H2 blocker]). At 10:31 p.m. Pt 5 received a dose of epinephrine IM, and at 10:38 p.m., Pt 5 received a dose of racemic epinephrine (inhaled). At 11:47 p.m. Pt 5 received Toradol 15 mg IV for headache and Zofran 4 mg IV for nausea.

Review of the record indicated at 11 p.m. a chest x-ray was completed and indicated low lung volumes, pulmonary vascular crowding vs congestion.

Review of the ED Physician's Note indicated, "...Medical Decision Making- ED Course: Patient is pretty significantly somnolent now with the amount of Benadryl she received. Have added on some Solumedrol [a steroid] and Pepcid. She already received epinephrine. She is really having minimal wheezing now. Will give her some fluids as well but we will just monitor her for a while... She started wheezing again, required another dose of epinephrine and gave her some racemic epi. She is doing much better after this. She is asking for something for headache and nausea. I [have] given her some Toradol and Zofran. I [have] written her for some prednisone for home. Pt stable for discharge, return precautions have been given..." The ED Physician's note was signed on 3/24/24 at 11:26 p.m. by MD 3.

The record indicated a discharge order was placed at 11:20 p.m. Vital signs prior to discharge were temp 98.5 F Pulse 89 bpm, respirations 18, BP 145/100 mmHg. Pt 5 was discharged on 3/25/24 at 12:15 a.m. Diagnosis: Anaphylaxis (An acute, life-threatening systemic allergic reaction).

During a record review on 5/14/24 at 10:35 a.m. with the EDM, Pt 5's medical record dated 3/25/24 was reviewed. The medical record indicated Pt 5 was brought to the ED by ambulance on 3/25/24 at 7:10 p.m. Review of the Patient Care Record (PCR- Emergency Medical services [EMS] record of prehospital care) dated 3/25/24 indicated at 6:42 p.m., "Family advised pt had an anaphylaxis event yesterday...Pt has been complaining of chest pain with sob [shortness of breath] since waking up thismorning. Family advised at 6:30 p.m. Pt became unresponsive, so family administered two doses of epi pens [epinephrine] with no improvements. Upon EMS contact pt had audible wheezes bilaterally with no visible airway swelling...Pt had equal pupils at 3 mm..." The PCR indicated at 6:43 p.m. Pt 5's Glasgow Coma Scale (GCS- describe the extent of impaired consciousness) score was 8 (unresponsive, range is 3-15, 15 being completely alert and oriented) and at 6:52 p.m. the GCS score was 7. Pt 5 was given a dose of Benadryl IM and a dose of epinephrine IM at 6:44 p.m. Vital signs at 6:52 p.m. were pulse 120 bpm, respirations 19, BP 154/88 mmHg, oxygen saturation 99% on oxygen 15 liters via non-rebreather mask. The PCR indicated the ambulance arrived at the ED at 7:07 p.m.

Review of the triage nurses notes indicated Pt 5 was triaged at 7:28 p.m. and assigned an ESI of 1 (Immediate). Reason for visit: "Altered level of consciousness with possible allergic reaction. Per EMS patient was here yesterday of allergic reaction to shrimp," Triage vital signs were temperature 99.4 F, pulse 123 bpm, resp 16, BP 193/114 mmHg, and oxygen saturation 100% on 15L oxygen non-rebreather mask.

Review of the respiratory therapist's note dated 3/25/24 at 7:40 p.m., indicated, "...Assisted with intubation...pt switched to vent..."

Review of the ED Physician's note dated 3/25/24 at 7:49 p.m. indicated, "...biba [brought in by ambulance] from home for decreased consciousness and anaphylaxis...She received two doses of epi IM, 3 prednisone and 1 dose of diphenhydramine [Benadryl] IV, as well as 1 dose Narcan IM...the decision was made to intubate after patient became apneic...History was collected from patient's mother. Last night she [Pt 5] ingested 3 shrimp and had an allergic reaction. Her mother administered an epi pen and the patient was brought to the ED. She was discharged last night. Upon returning home today she was complaining of chest pressure...Last seizure was last night..." The record indicated Pt 5 was admitted to ICU.

During an interview on 5/14/24 at 12:57 p.m. with the ED medical director (EDMD), the EDMD stated there is a risk of rebound anaphylaxis after epinephrine is given and patients should be observed for at least two and a half to 3 hours after receiving epinephrine. The EDMD stated Pt 5 may have benefited from a longer period of observation.

During a review of the reference American Family Physician Volume 102, Number 6 September 15, 2020 article titled "Anaphylaxis: Recognition and Management," the article indicated, "...Patients should be monitored for a biphasic reaction (i.e., recurrence of anaphylaxis without reexposure to the allergen) for four to 12 hours, depending on risk factors for severe anaphylaxis A minimum observation period of four hours supports current guidelines, with longer observation periods recommended based on individualized factors such as previous biphasic reaction, severity of initial presentation, treatment with multiple doses of epinephrine, a previously protracted anaphylactic reaction, unknown anaphylactic trigger, or presence of risk factors for severe or fatal anaphylaxis..."

During a review of the reference article titled "Anaphylaxis-a 2020 practice parameter update, systematic review, and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) analysis," in The Journal of Allergy and Clinical Immunology volume 145, issue 4 April 2020, the article indicated, "... After diagnosis and treatment of anaphylaxis, all patients should be kept under observation until symptoms have fully resolved. We suggest that a clinician incorporate severity of anaphylaxis presentation and/or the administration of >1 dose of epinephrine for the treatment of initial anaphylaxis as a guide to determining a patient's risk for developing biphasic anaphylaxis. We suggest extended clinical observation in a setting capable of managing anaphylaxis (to detect a biphasic reaction) for patients with resolved severe anaphylaxis and/or those who need >1 dose of epinephrine..."

During a review of the Allergy and Asthma Network reference "Anaphylaxis," retrieved from https://allergyasthmanetwork.org/anaphylaxis/ , the reference indicated, "...Symptoms normally peak within a half-hour of exposure, but they can last for several hours. About 20% of the time, you can get your symptoms under control with treatment, but they may come back. This is what is known as a biphasic reaction - a second reaction. This is why it is important to seek emergency care after using epinephrine..."

During a review of the Food Allergy Research and Education [FARE] Field Guide, the guide indicated,"...Transport person to the emergency room (ER), even if symptoms resolve. The person should remain in the ER for at least 4 hours because symptoms may return..."

2. During a review of the ED log dated 4/17/24, the log indicated Pt 6 came to the ED on 4/17/24 at 9:45 p.m. with a chief complaint of left sided abdominal pain and left against medical advice (AMA) at 3:18 a.m. on 4/18/24. Review of the ED log dated 4/18/24 indicated Pt 6 came back to the ED on 4/18/24 at 12:50 p.m. with a chief complaint of catheter issues. and was admitted to the hospital.

During an interview on 5/14/24 with the interventional radiology manager (IRM), the IRM stated Pt 6 underwent bilateral nephrostomy tube replacement in the afternoon of 4/17/24. The IRM stated it was discovered later that the stylet was not removed from one of the nephrostomy tubes (the left) after placement. The IRM stated initially when Pt 6 came back to the hospital the cause of the problem was not known so Pt 6 was scheduled to undergo another procedure on 4/19/24. However, when they were preparing for the procedure the tech noticed the stylet and it was removed correcting the problem. The IRM stated when the stylet is left in, there is a yellow hub (connector) that is visible. The IRM stated verifying the stylet has been removed from the nephrostomy tube after placement is a shared responsibility between the physician placing the nephrostomy tube and the staff in IR taking care of the patient.

During a review of Pt 6's medical record dated 4/17/24, the record indicated Pt 6 was a 61 year old patient with a history of ovarian cancer, currently undergoing treatment. The triage record indicated Pt 6 came to the ED by car on 4/17/24 at 9:45 p.m. and was triaged at 9:54 p.m. The triage RN's note indicated, "Patient had nephrostomy tubes bilateral since Dec 2023. Today [in the] morning she had them changed. Patient coming now stating that the left nephrostomy tube is not draining, and she has severe pain." Pt 6's vital signs were taken and indicated, temperature 99.1 degrees Fahrenheit (F), pulse 113 beats per minute (bpm- normal 60-100)), respirations 16 per minute, blood pressure 130/71 millimeters of mercury (mmHg), oxygen saturation 96% on room air. Pt 6 reported acute left flank (area on side of back below rib cage) pain, pain level of 9/10 (severe pain; 0 is no pain, 10 is the worst pain), was assigned an ESI of 2 (very urgent) and was sent to the lobby to wait.

Review of the record indicated Pt 6's medical screening examination (MSE) was started by the nurse practitioner (NP 1) on 4/17/24 at 10:38 p.m. Review of NP# 's "ED RME Note" dated 4/17/24, indicated, "...Pt states that she got both nephrostomy bags replaced today here at Interventional Radiology [IR] but mentions that the left nephrostomy bag is not working at all since it was placed...Pt stated that nephrostomy bag was first placed back in December of 2023...Pt states she is on chemotherapy and will start a new one on Monday 4/22/2024...Physical Exam: Gastrointestinal- Left nephrostomy bag not working and yellow connector on the left nephrostomy bag is present but not on the right one..." The record indicated lab tests and a CT scan were ordered and Pt 6 remained in the lobby.

Review of Pt 6's record indicated labs were drawn at 11:54 p.m., were resulted on 4/18/24 at 12:20 a.m. and indicated wbc 20.8 (normal range 4.5-11), neutrophil percent 87.3 (high), absolute neutrophil 18.1 (high), BUN/creatinine ratio 27 (10-20).

Review of Pt 6's record indicated MD 3 saw Pt 6 on 4/18/24 at 12:02 a.m. Review of the ED Physician Notes dated 4/18/24 at 12:03 a.m. indicated, "...HISTORY OF PRESENT ILLNESS: 61 year old with ovarian cancer. Underwent PCNT [percutaneous nephrostomy tube] exchange with IR this afternoon here at [name of hospital]. Pt states there has been no output from the left nephrostomy tube since then and she is having pain at the site, that is not relieved with Norco. Last took one Norco at 6/6:30 p.m... PHYSICAL EXAM: Mild distress, ill-appearing...Abdomen: Distended, firm abdomen, bilateral percutaneous nephrostomy tubes with 100 ml [milliliters- unit of measure] serosanguinous fluid in right, no output in left, left flank tender to palpation with voluntary guarding..." Medical Decision Making: "...CT abdomen was ordered to rule out possible tube dislodgement...Patient's lab work returns with leukocytosis [high wbc] and neutrophil predominance. May just be postsurgical but do think she will require a CT scan. She is pending CT at this time. Urinalysis looks fairly benign..." The record indicated Pt 6 continued to wait in the lobby.

Review of Pt 6's record indicated Pt 6 remained in the lobby since triage at 9:54 p.m. on 4/17/24. There were no further nurses notes after triage until 3:18 a.m. on 4/18/24, no vital signs, no pain reassessment and no pain medication given.

On 4/18/24 at 3:18 a.m. the triage nurse's notes indicated "Patient decided to leave and does not want to wait further, stated she will come back in the morning...got MD who explained the risk of leaving, pt signed AMA and left..."

Review of the ED Physician Notes dated 4/18/24 starting at 12:03 a.m. indicated, "was called back to triage as patient is wanting to leave. I did discuss at length with her and understand her frustration at the long wait times but did let her know that I think she still needs to get the CT scan...I discussed with her that I cannot guarantee her safety without her staying...her plan is to come back in the morning when IR is present so maybe she can be seen faster...She would like to leave against medical advice..." Review of the form titled "leaving against medical advice dated 4/18/24 was signed by Pt 6 at 3:16 a.m. and at 3:23 a.m. by MD # who indicated, "Discussed Risk of Morbidity and Mortality."

Review of Pt 6's medical record dated 4/18/24 indicated Pt 6 returned to the ED at 12:50 p.m. and was triaged at 1:12 p.m. The triage nurses note indicated, "Pt states she was here yesterday to have her nephrostomy tubes replaced, and pt states that her left one has not functioned since it was replaced. Pt states she has ovarian cancer and is getting treatment for the cancer..." Vital signs obtained, pain level assessed as 5/10 (moderate) left flank pain. Assigned an ESI of 3. Review of the ED physician assistant note dated 4/18/24 at 1:49 p.m., indicated Pt 6's left nephrostomy collection bag was empty. There was no mention of the appearance of the nephrostomy sites. An ultrasound was performed and indicated the tube was positioned appropriately within the kidney. The IR physician was contacted, and indicated he would replace the left nephrostomy tube the next day (4/19/24). Pt was admitted by the hospitalist on 4/18/24 at 4:33 p.m. Review of the IR report dated 4/19/24 indicated Pt 6 was in IR on the procedure table at 10:13 a.m. At 10:23 a.m. the report indicated, "Dr determined L nephro tube working properly, procedure cancelled." On 4/23/24 (four days after the procedure) IR MD's documented "...1 plastic insert was left in patient...The patient returned, and the stylet was removed. Malfunctioning catheter was then fully functional. No foreign body remains in this patient..."

During a concurrent interview and record review on 5/15/24 at 2:50 p.m. with the Assistant Patient Care Executive (APCE- formerly the ED director) and the ED manager (EDM), the APCE stated patient's with an ESI of 2 should not wait in the lobby. The EDM manager stated she was unable to find any vital signs had been taken after triage and does not have an explanation for why Pt 6's severe pain was not addressed. The APCE stated this was a busy night in ED but that does not explain why this patient remained waiting in the lobby for over five and a half hours without having her vital signs checked or pain medication. The APCE stated they had adequate nursing staff on that night. The APCE indicated they have been having issues with getting CT scans read at night but that should not affect the scan being done. There is no indication in the record as to why the scan was not done by 3:15 a.m. on 4/18/24 when it had been ordered on 4/17/24 at 10:45 p.m.

During a concurrent interview and record review on 5/15/24 at 3:10 p.m. with the APCE, the "ED RME Note" dated 4/17/24 at 10:38 p.m. was reviewed. The NP's assessment regarding the nephrostomy tubes indicated, " Left nephrostomy bag not working and yellow connector on the left nephrostomy bag is present but not on the right one..." The APCE stated this assessment indicated the yellow connector (stylet) was noted during that first ED visit on the day of the procedure (4/17/24). There was no indication in the record that the difference in the appearance of the left and right nephrostomy tubes was communicated to anyone or that the sites were assessed, or difference noticed by anyone else caring for Pt 6.

Review of the Policy and Procedure (P&P) titled, "Standards of Care , Emergency Department," dated 3/5/24, indicated, "...Vital sign assessment to be completed at triage, with any change in the patient's condition, in response to a treatment, and at discharge along with the minimum routine frequency based on acuity: ESI Level 2: every hour for the first 4 hours, then every 2 hours if clinically stable... All patients will be triaged by a registered nurse. All patients will have an inital assessment and prioritized treatment per Emergency Severity Index Level 1-Immediate, Level 2 Very Urgent, Level 3- Urgent... Initial pain level will be assessed, and if the patient has pain, reassessment will be recorded a minimum of every 2 hours...Nurses will perform the skills required to meet the patient's needs, including education and communication regarding treatments and care..."

During a review of the professional reference titled," Emergency Severity Index, A triage Tool for Emergency Department Care, Version 4," dated 2020, the reference indicated, "...When the patient is categorized as ESI level 2, the triage nurse has determined that it would be unsafe for the patient to remain in the waiting room for any length of time. While ESI does not suggest specific time intervals, ESI level-2 patients remain a high priority, and generally, placement and treatment should be initiated rapidly. ESI level-2 patients are very ill and at high risk. The need for care is immediate and an appropriate bed needs to be found..."