More than one-third of ED patients with septic shock reported only vague symptoms at presentation, according to the authors of a recent study of 654 septic shock patients discharged from a large urban ED.1 These patients had delayed antibiotic administration and were at a higher risk of mortality compared to patients with explicit infection symptoms.
Another recent analysis revealed that a faster completion of a three-hour bundle of sepsis care and quick administration of antibiotics — but not rapid completion of an initial bolus of IV fluids — were associated with lower risk-adjusted, in-hospital mortality rates.2
“Sepsis can present with pathophysiologic alterations that precede the signs and symptoms that typically herald the onset of infection,” notes Edward Monico, MD, JD, assistant professor in the department of emergency medicine at Yale University School of Medicine. He says that altered mental status, unexplained hyperglycemia, and inflammatory variables such as leukocytosis, leukopenia, more C-reactive protein, and increased procalcitonin production can occur before other signs and symptoms of sepsis. Further, acute oliguria, creatinine increase, coagulation abnormalities, thrombocytopenia, and hyperbilirubinemia are known to arise during early sepsis, before signs of significant systemic infection such as fever, hypotension, and hypoxia. “In the right clinical setting, physicians who suspect an illness is more severe than a patient might appear and order these markers are in the best position to detect early signs of sepsis,” Monico says.
When these tests are not obtained, early sepsis can be missed. “This places patients at risk if they are discharged before treatment for foreseeable organ dysfunction can be initiated,” Monico warns.
A retrospective database review conducted over 14 years with more than 1.1 million admissions for severe sepsis to 172 ICUs showed that only 87.9% were SIRS-positive. This left 12.1% of patients SIRS-negative, based on the traditional definition of sepsis.3
“This means that even when published guidelines on sepsis are followed, sepsis can be difficult to diagnose,” Monico explains.
This is true for elderly patients who cannot mount a response, patients on medications that blunt a tachycardic response, or immunocompromised patients. “One way liability can attach is when treatment for sepsis is delayed or missed altogether because the pathophysiologic alterations of sepsis existed but were not appreciated for what they were,” Monico says.
Typically, patients in missed sepsis cases sought care early at the ED and were discharged, only to return with fulminant sepsis. “If early signs of sepsis were present, the standard of care might establish that such signs were sufficient to warrant either further investigation of or treatment for sepsis,” Monico says.
In one missed sepsis case, a 35-year-old man presented to an ED with fever, chills, body aches, and elevated body temperature, pulse rate, respiratory rate, and white blood count.4 The man’s medical history included a splenectomy and a hip replacement. The patient was reportedly diagnosed with a viral syndrome. “Attorneys assert that although the diagnosis of sepsis may not have been obvious, his predisposition for infection ... required further evaluation for sepsis than what was performed,” Monico says.
A common issue in missed sepsis ED cases is surprisingly simple. EPs correctly order blood cultures to rule out infection, but the patient is gone by the time the results return. “This becomes a problem in patients who have minimal symptoms [and] do not otherwise warrant admission,” says Jason Newton, senior vice president and associate general counsel at Medical Mutual in Raleigh, NC.
By the time the blood culture results return positive, the patient is discharged. Either the results are not communicated and the patient does not come back until they are in extremis, or the patient decompensates quickly after discharge. Either way, Newton says two questions become important during litigation: Who is responsible for communicating culture results after discharge — the hospital or the EP? Also, did the patient have other symptoms or comorbidities that should have warranted admission or observation until the culture results returned? Here are some recent missed sepsis cases Newton handled:
• The parents of an otherwise healthy 5-week-old infant male presented to the ED for evaluation of the child’s fever and irritability. The EP described the infant as awake, alert, and appropriately fussy with placement of an IV. Other than a fever of 100.8 degrees Fahrenheit, his vital signs were normal. The EP proceeded with a bacteremia workup, chest X-ray, CBC, blood cultures, urine culture, and RSV tests. A urinalysis and RSV screen were negative, and the chest X-ray was unremarkable. The infant had developed some stridorous respirations but did not show signs of respiratory distress and improved after a dose of Decadron.
“Our insured physician spoke with the parents about keeping the infant in the hospital overnight for observation and proceeding with a lumbar puncture,” Newton notes.
The parents stated that they felt comfortable taking their child home, would follow-up with the pediatrician in the morning, and agreed to return to the ED if the infant’s condition worsened. After the decision to discharge the baby had been made, his vitals were taken again. He had a fever of 102.5 degrees Fahrenheit. The EP repeated the offer to keep the infant overnight, but the parents declined. The infant was discharged from the ED with a diagnosis of fever of unknown origin.
The next morning, the preliminary blood culture results came back and were significant for a gram-positive organism. An ED nurse contacted the parents to instruct them to return to the ED, but the mother declined, stating that they had an appointment with the pediatrician that day. The child’s fever was better, but he was still experiencing some “noisy” breathing. The hospital ED nurse called the child’s pediatrician and notified the staff of the culture results.
Later that morning, the parents brought their infant to the ED. Upon arrival, his skin was pale and mottled and he was experiencing grunting respirations. While under evaluation, the child became bradycardic and his oxygen saturation levels decreased. The child was intubated and required resuscitation. He was admitted to the pediatric ICU, where he was diagnosed with sepsis, respiratory failure, meningitis, and hypothermia. “Despite aggressive measures, the child died one week later as a result of overwhelming sepsis,” Newton says.
The infant’s age placed him on the “borderline” category as to the recommendations for when to obtain a lumbar puncture, admit, and administer antibiotics. All these became issues in malpractice litigation. “The most difficult aspect to defend was our insured’s decision to discharge the infant who was experiencing stridor and a spike in his temperature at the time of discharge that was outside of typical discharge criteria,” Newton reports.
Defense experts believed a lay jury would conclude that given the potential consequences, it would have been better to err on the side of caution and, at a minimum, admit the child for observation. “For this reason, a settlement was reached outside of court,” Newton says.
• A 47-year-old male was evaluated in the ED for low back pain. The patient was discharged with a diagnosis of lumbar strain and instructions to follow up with an orthopedist. He died a week later as a result of acute pyelonephritis and bilateral pneumonia. The plaintiff attorney alleged that the EP failed to consider a urinary tract infection. No urinalysis was ordered in the ED. “The case was defended at trial and won because the jury determined the patient should have revealed urinary symptoms, and he did not,” Newton says.
• A 50-year-old diabetic male presented to the ED with abdominal pain that had been ongoing for a week, along with constipation and chills. The abdominal exam was benign. His testicles were enlarged. A scrotal ultrasound showed bilateral hydroceles. The only lab test ordered was a urinalysis, which was positive for ketones, protein, mucous, and bacteria. The patient was discharged with a diagnosis of constipation, but he returned to the ED the following day with jaundice, altered mental status, a diffuse dark rash, and a fever of 107.6 degrees Fahrenheit. He arrested and expired within an hour of presentation to the ED.
Blood cultures tested positive for Clostridium perfringens. The autopsy revealed the cause of death was sepsis related to enteritis and liver abscess. “The case was difficult to defend due to lack of blood work orders in ED,” Newton says. The plaintiff alleged that the EP also should have ordered a surgical consult and that abnormal lab results would have led to additional testing and/or admission that would have detected the patient’s developing sepsis and prevented his death. The case was settled.
• A 20-year-old female presented to the ED following delivery of a child two days prior, complaining of pain all over her body and sweating. The initial exam revealed no vaginal discharge. Her vital signs were normal except for slight tachycardia. The EP indicated there were no classic signs of post-partum infection, such as abdominal tenderness, fever, or elevated white blood cell count. The patient improved during her stay in the ED with pain medications. She was discharged with instructions to follow-up with her OB/GYN, which she did two days later. There, the physical exam was unremarkable. No labs, ultrasound, or CT were ordered. The patient was found deceased three days later. The cause of death was septic shock with disseminated intravascular coagulation due to acute endometritis.
Defense experts indicated that complaints of pelvic pain and fever two days post-partum should have led to a more aggressive workup in the ED, including labs and diagnostic testing. “However, our experts also indicated that this failure by our insured did not result in the patient’s death,” Newton says. As instructed, the patient presented to her OB/GYN, who also failed to appreciate the seriousness of the patient’s condition.
“It was this specialist’s lack of a more aggressive workup that ultimately led to the patient’s death,” Newton explains. However, due to the EP’s failure to initiate an appropriate workup at the ED, it was determined that he also would be held accountable for the patient’s death. “Therefore, a reasonable contribution was negotiated, and the claim was settled outside of court,” Newton says.
- Filbin MR. Lynch J, Gillingham TD, et al. Presenting symptoms independently predict mortality in septic shock: Importance of a previously unmeasured confounder. Crit Care Med 2018;46:1592-1599.
- Seymour CW, Gesten F, Prescott HC, et al. Time to treatment and mortality during mandated emergency care for sepsis. N Engl J Med 2017;376:2235-2244.
- Kaukonen KM, Bailey M, Pilcher D, et al. Systemic inflammatory response syndrome criteria in defining severe sepsis. N Engl J Med 2015;372:1629-1638.
- Bern v. Holy Cross Health, Montgomery County, MD, Jan. 7, 2016. Available at: . Accessed March 8, 2019.