Magnolia Medical’s Steripath delivers critical time savings for sepsis diagnosis, improving patient outcomes and providing cost efficiencies for health care providers. 

By Chris Wolski

Sepsis has become a significant challenge for many health care providers, and its prevalence is increasing. And the statistics are sobering: About 6% of all hospitalizations and 35% of in-hospital deaths are attributable to sepsis, making it the leading cause of death in U.S. hospitals1.

With sepsis time is of the essence. Each hour delay in treatment increases patient mortality by 4% to 9%1. That’s why fast and effective sepsis diagnosis is critical. Unfortunately, while the gold standard diagnostic tools are effective, they are time consuming.

Magnolia Medical’s Steripath is a point-of-care solution that’s designed to be sensitive and fast, giving clinicians and patients time for sepsis diagnosis and treatment. CLP recently sat down with Magnolia Medical’s CEO, Greg Bullington, to get an overview of how the Steripath solution works, the challenges of sepsis diagnosis, and the role clinical labs play in delivering results from Steripath tests.

Answers have been edited for length and clarity.

CLP: There seems to be more and more discussion about sepsis today—is it on the rise or is it because we have better means for sepsis diagnosis?

Greg Bullington: Bloodstream infections, including sepsis, have been a leading cause of patient deaths, costs, and readmission for U.S. hospitals for years. CMS and the Agency for Healthcare Research & Quality estimate the U.S. healthcare system alone spends about $38 billion annually on sepsis, with costs rising about 8% a year and most hospitals losing money on every case.

To make matters worse, per the CDC, the number of sepsis cases per year in the U.S. has been on the rise, likely due to several factors:

  • There is increased awareness and tracking of sepsis, so more cases may be recognized than they were previously.
  • People with chronic diseases are living longer. Sepsis is more common and more dangerous in those with other illnesses and in older adults.
  • Some infections can no longer be eliminated with antibiotic drugs. Antibiotic-resistant infections can lead to sepsis.
  • Organ transplants are more common. People are at higher risk for sepsis if they’ve undergone any procedure that requires the use of medications to suppress the immune system, including organ transplantation.

It is also notable to point out the number of individuals who have either been directly affected by sepsis or had a loved one impacted. In a recent survey of over 1,000 respondents, nearly one- in-three survey participants indicated that they or a loved one had been impacted by sepsis. Not surprisingly, the risk of acquiring sepsis during a hospital stay was cited as the No. 1 infection fear risk from this same pool of respondents.

CLP: What have been traditional best practices for sepsis diagnosis? And why are they so time consuming?

Bullington: Blood cultures are the gold standard test for diagnosing blood stream infections, including sepsis. Blood cultures confirm the presence of microorganisms, identify the microbial etiology of the bloodstream infection, help determine the source of infection, and provide an organism for susceptibility testing and optimization of antimicrobial therapy. This blood test is one of the most clinically important and frequently performed diagnostic tests in U.S. hospitals; however, nearly 40% of positive blood culture results are false-positive due to contamination in a typical hospital.

False positives are a preventable error that can lead to a misdiagnosis of sepsis. A patient with a blood culture result that indicates a possible or probable contaminant poses a clinical dilemma for the bedside physician. Even when rapid molecular diagnostic technologies are used for organism identification, final diagnosis and clinical decision-making can be a challenge since 12%-38% of potential contaminants can also be a source of true bacteremia depending on patient population.

The bedside physician needs to determine whether to continue or discontinue antibiotic treatment. If they choose to discontinue and send the patient home (or continue to monitor) and it is a true bloodstream infection, the patient is faced with increased morbidity and mortality risk. That is a risk most physicians are not willing to take. More often than not, the physician will elect to continue antibiotics and observe or admit the patient. This puts the patient in harm’s way and adds to the global crisis of antibiotic resistant organisms. Antibiotics are a primary driver of multi-drug-resistant organisms leading to antibiotic-resistant infections that are a significant problem in our hospitals today. They contribute to the onset of C. difficile in our hospitals, as well as several other antibiotic-related complications such as acute and long-term kidney injury.

It can also extend the patient’s length of stay. According to two recent publications, patients that experience a false-positive blood culture have an extended length of stay of 2.0 to 2.4 days compared to those with a negative culture. The longer a patient remains in the hospital the greater the exposure to other healthcare acquired infections and conditions. Finally, patients impacted by a contaminated blood culture had a significant, near doubling—8% versus 4.6%—of the mortality rate for patients that had contaminated blood cultures vs. the true negative blood culture control group.

CLP: Magnolia Medical has developed a bedside-collection device that is very easy to use and, more importantly, has a high accuracy rate for sepsis diagnosis. Can you give an overview of the device and how it improves on the traditional best practices?

Bullington: When we think about blood culture collection, many hospitals spend a tremendous amount of time training and educating on the controllable human factors that increase the risk of contamination. This includes touchpoint contamination during assembly and preparation of supplies to draw the blood culture and meticulous skin prep activities.

However, while you can disinfect skin, it cannot be sterilized and up to 20% of skin flora remains viable in the keratin layer of the skin, even after appropriate skin prep. In performing a venipuncture with a hollow bore needle, it creates a skin plug and fragments, similar to the effect of pushing a hollow pipe into mud. These skin plugs and fragments are uncontrollable factors that, when present, will always enter the culture specimen bottle, and commonly will contain microorganisms which contaminate the blood culture. Therefore, blood culture contamination is often due to factors that are out of the control of the nurse or phlebotomist performing the collection.

Steripath addresses both controllable and uncontrollable factors of blood culture contamination and solves the problem at its source by preventing a contamination so there is no “potential” contaminated blood culture for the bedside clinician to react to and no clinical decision dilemma to continue or discontinue antibiotics. With Steripath, we are engineering out human factors. It’s preassembled sterile to reduce the risk for touch point contamination and can provide a ”vein-to-bottle” closed system.

The device actively diverts the initial 1.5 to 2.0 mL of blood which is known to contain contaminants. This diversion volume has been clinically proven effective to virtually eliminate blood culture contamination in 20 studies, nine peer-reviewed publications, and is supported by guidelines from professional societies, like the ENA (Emergency Nurses Association) and INS (Infusion Nurses Society), as well as by the CLSI (Clinical and Laboratory Standards Institute).

After diversion is complete, a second, independent sterile blood flow pathway is mechanically opened to allow for pure venous blood to flow into the culture bottle. Steripath is also designed to prevent the diverted blood from mixing with the culture specimen and bypassing diversion. The end-user cannot collect the specimen until diversion is complete, engineering compliance into the process.

CLP: Can you discuss the study you did with the University of Nebraska Medical Center, and what it means broadly for accurate sepsis diagnosis?

Bullington: This study evaluating the reduction in blood culture contamination was conducted by Dr. Mark Rupp, MD, professor and chief of the Division of Infectious Diseases and Medical Director, Department of Infection Control and Epidemiology at the University of Nebraska Medical Center. The results were published in Clinical Infectious Diseases in July 2017.

Dr. Rupp designed the study such that the results would be irrefutable. This was a prospective, controlled, matched-pair clinical trial performed in the ED over a 12-month period including 904 patients and 1,808 blood cultures. The phlebotomist team collected two cultures from each subject so that each patient served as their own control; one using phlebotomy best practices and one using Steripath.

During a 6-month pre-intervention period, the contamination rate of the phlebotomy group was monitored and reported to be 2.6%. During the 12-month intervention period the phlebotomy group, using best practices, were able to reduce their contamination rate down to 1.8%.

This was primarily due to what’s called the Hawthorne effect. Meaning, the phlebotomists were being observed and monitored during the study, so they were using meticulous technique, but they were only able to reduce the rate to 1.8%. This is like how most drivers will slow down and drive the speed limit when a police car pulls up behind them.

The same phlebotomy group with the same patient on the contralateral arm, when using Steripath, was able to reduce blood culture contamination to 0.2%, a statistically significant result that represented an 88% reduction and with no change in true bacteremia detection.

Steripath was taken away for a 6-month post intervention period, during which time the same phlebotomy group using only phlebotomy best practices reported a 2.8% contamination rate. Based on this 93% increase in contamination and return to above baseline after Steripath was taken away, it seems irrefutable that Steripath made the difference. Additionally, the authors estimated that UNMC would save $1.8M per year if Steripath was used for all blood culture draws hospital wide.

CLP: How are clinical labs involved in the sepsis diagnosis process with Steripath?

Bullington: Clinical laboratories, and specifically microbiology laboratories, are directly responsible for processing blood cultures. As you can imagine, blood culture contamination can have a significant negative impact on laboratory efficiency and productivity.

It negatively impacts workflow by requiring unnecessary tests for 35% to 50% of positive blood cultures and unnecessary communication with caregivers in the reporting of this critical value. Potential additional tests that may be run even for a potentially contaminated blood culture result include:

  • Microscopic analysis (Gram stain, etc.)
  • Secondary cultures
  • Organism identification
  • Biochemical identification
  • Molecular identification (PCR, NAAT, MALDI-TOF, FISH)
  • Rapid diagnostics
  • Antimicrobial susceptibility testing (AST)
  • Antimicrobial serum level monitoring (e.g., vancomycin peak and trough levels)
  • Ancillary chemistry and hematology tests
  • Additional blood cultures

It also negatively impacts lab process, productivity, and performance, and can be a major contributor to overtime in the lab and significant increased avoidable costs. Lastly, laboratories are sometimes “blamed” as the source of high contamination events due to inappropriate specimen handling when in actuality, the contamination event may be occurring right at the bedside.

CLP: Apart from being effective – what kinds of improvements in outcomes and cost savings can organizations expect to see from Steripath?

Bullington: As indicated, there have been 20 Steripath studies, including nine national peer-reviewed publications. All clinical studies reported a reduction in blood culture contamination from 75% to up to 100% with sustained rates from 1.0% to as low as 0.0% in over 11,202 cultures. Average annualized cost savings were reported to be over $1 million. Additionally, one study performed at a military hospital reported a 31% reduction in vancomycin DOT with the adoption of Steripath.

By reducing blood culture contamination rates with Steripath, hospitals can also realize the potential benefits of shortening average length of stay and reducing the risk of in-patient mortality as these downstream issues have been studied and identified to be directly correlated to a blood culture contamination event.

Additionally, Steripath has an industry leading clinical performance guarantee—achieve 50% or greater reduction in blood culture contamination rates or your money back for as long as the product is used.

CLP: Is Steripath currently available?

Bullington: Steripath has been adopted by hundreds of U.S. hospitals and healthcare systems to address the problem of blood culture contamination.

Chris Wolski is chief editor of CLP.

Reference

  1. Sepsis Fact Sheet. Sepsis Alliance. December 2020. www.sepsis.org/sepsis-basics/what-is-sepsis/