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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Hospitals Test New Technology That Can Help Reduce Unacceptable Rates of Contaminated Blood Culture Specimens

Especially for busy hospital emergency departments, avoiding blood culture contamination is a constant challenge for those tasked with collecting blood culture specimens

Better, faster diagnosis and treatment of sepsis continues to be a major goal at hospitals, health networks, and other medical facilities throughout the United States. Yet microbiologists and clinical laboratory managers continue to be frustrated with how frequently contaminated blood culture specimens show up in the laboratory.

A recent poll of more than 200 healthcare professionals who attended a sponsored webinar hosted by Dark Daily, showed that nearly 10% of those who responded reported an overall blood culture contamination rate in their hospitals at above 4%.

However, the arrival of new technology may provide hospital staff with a way to reduce contamination rates in blood culture specimens, in ways that improve patient outcomes.

The effectiveness of a new tool, the Steripath Initial Specimen Diversion Device (ISDD), is being demonstrated in a growing number of prominent hospitals in different regions of the United States. What will be particularly intriguing to clinical laboratory professionals is that the ISDD is capable of collecting blood while minimizing the problems caused by human factors, micro-organisms, and skin plugs or fragments. This device was developed by Magnolia Medical Technologies of Seattle, Wash.

The ISDD isolates the initial 1.5 to 2.0 mL aliquot of the blood culture sample, which is most likely to be contaminated with microscopic skin fragments colonized with bacteria. The device diverts this initial aliquot into a sequestration chamber, mechanically isolating it from the rest of the sample, and then automatically opens an independent sterile pathway into blood culture collection bottles. 

Such technology may be welcomed by medical laboratory professionals based in hospitals and other healthcare facilities. That’s because it is the lab staff that typically identifies a contaminated blood culture specimen and must go back to the nurses, staffers, and physicians on the wards to have them redraw an acceptable specimen that will produce an accurate, reliable result. Patients under these circumstances generally continue on unnecessary broad-spectrum antibiotics, and their length of stays have been reported to increase by two days on average.

Problem of Decentralized Phlebotomy

One problem contributing to high blood culture rates is that, in many hospitals and health networks, phlebotomy has been decentralized and is no longer managed by the clinical laboratory.

“I’ve seen the havoc decentralized phlebotomy wreaks on contamination rates of blood culture rates,” stated Dennis Ernst, Director of the Center for Phlebotomy Education based in Mio, Mich. “That staffing model, which swept through the hospital industry in the late 1990s, may have looked good on paper, but I can count the number of facilities that have successfully decentralized on the fingers of one hand. And I don’t know of any decentralized setting that has an acceptable blood culture contamination rate.”

Dennis Ernst, MT(ASCP), NCPT(NCCT) (above), Director of the Center for Phlebotomy Education, shared his expertise during a recent webinar hosted by Dark Daily. Ernst considers blood culture contamination to be among the “low-hanging fruit” in every medical laboratory that can be easily and permanently corrected with the proper approach. (Photo copyright: Dennis Ernst.)

Ernst, a medical technologist and educator, has seen the difficulty in lowering contamination rates in a decentralized, multidisciplinary workforce. He has worked for more than 20 years advocating for best practices in the diagnostic blood collection industry and has helped clinical laboratory facilities achieve a 90% reduction in their contamination rates. Ernst considers blood culture contamination to be among the “low-hanging fruit” in every laboratory that can be easily and permanently corrected with the proper approach. 

“One statistic we’ve heard over and over again is that the American Society of Microbiology established the ‘threshold’ for blood culture contamination to be 3%,” Ernst said. “I believe strongly that a 1% contamination rate or less is what should be required and that it’s not only achievable, but sustainable.”

Regardless of staffing mix, blood culture contamination is a common problem in the emergency department, Ernst explained during his presentation, “Evidence-Based Technology to Reduce Blood Culture Contamination, Improve Patient Care, and Reduce Costs in Your Clinical Lab or Hospital,” which is available free for streaming.

Improving Patient Care and Reducing Avoidable Costs

With unnecessary antibiotic use, increased length of stay, and the cost of unnecessary laboratory testing at issue, hospitals are tracking blood culture collection results and exploring ways to reduce episodes of blood culture contamination. On these and other healthcare quality improvement aims, providers are publishing study results on contamination reduction and potential direct and indirect hospital cost savings. For example:

  • At the University of Nebraska, a prospective, controlled, matched-pair clinical study showed an 88% reduction in blood culture contamination with a 12-month sustained rate of 0.2% when Steripath was used by phlebotomists in the ED. The author estimated the institution would save approximately $1.8 million if the technology was adopted hospitalwide, reported an article in Clinical Infectious Diseases in July 2017.
  • Florida-based Lee Health system’s microbiology laboratory reported an 83% reduction in contamination rates comparing their standard method to ISDD for a seven-month trial period. Their systemwide potential cost avoidance estimates ranged from $4.35 million to nearly $11 million, reported an article in the Journal of Emergency Nursing in November 2018.
  • Researchers from Massachusetts General reported that ISDD is the single most effective intervention so far explored for reducing costs related to false-positive blood cultures, potentially saving the typical 250- to 400-bed hospital $1.9 million or $186 per blood culture and preventing 34 hospital-acquired conditions (including three C. difficile cases). The recent article “Model to Evaluate the Impact of Hospital-based Interventions Targeting False-Positive Blood Cultures on Economic and Clinical Outcomes” in the Journal of Hospital Infection explains more.

Blood Facilities Should be Tracking Their Contamination Rate

One of the biggest challenges faced during blood sample collection is making sure an organism is not inadvertently introduced into the blood. Therefore, importance has been placed on clinical laboratories and other healthcare providers developing policies and procedures to limit the introduction of likely contaminants.

“I believe most places monitor blood culture contamination, but they are not doing much that is effective to reduce it,” Ernst said. “That’s a real problem.”

To assist healthcare providers in blood culture quality improvement, the free webinar, “Evidence-Based Technology to Reduce Blood Culture Contamination, Improve Patient Care, and Reduce Costs in Your Clinical Lab or Hospital,” available on-demand through Dark Daily, can be downloaded by clicking here, or by pasting the URL “https://darkintelligenceprogramsondemand.uscreen.io/programs/evidence-based-technology-to-reduce-blood-culture-contamination-improve-patient-care-and-reduce-costs-in-your-clinical-lab-or-hospital” into a web browser.

This program, which polled more than 200 healthcare professionals, explores the clinical and economic significance of blood culture contamination, the downstream impact of false-positive blood cultures, and case-study evidence of sustained reductions in contamination.

—Liz Carey

Related Information:

Free On-Demand Webinar: Evidence-Based Technology to Reduce Blood Culture Contamination, Improve Patient Care and Reduce Costs

Magnolia Medical Captures $20M to Reduce Blood Culture Contamination

Reduction in Blood Culture Contamination Through Use of Initial Specimen Diversion Device

Model to Evaluate the Impact of Hospital-Based Interventions Targeting False-Positive Blood Cultures on Economic and Clinical Outcomes

Reducing Contamination of Blood Cultures: Consider Costs and Clinical Benefits

University of Nebraska Infectious Disease Researchers Study New Device That Could Help Clinical Laboratories and Phlebotomists Avoid Blood Culture Contamination and False Positive Results for Sepsis

University of Nebraska Infectious Disease Researchers Study New Device That Could Help Clinical Laboratories and Phlebotomists Avoid Blood Culture Contamination and False Positive Results for Sepsis

Additionally, the device also could help reduce antibiotic-resistant infections and other HAIs and HACs, though this result was not part of the study

Research findings indicate how a new system-in-a-box device that phlebotomists and clinical laboratories would use when drawing blood could reduce contamination of blood cultures and lower patients’ use of antibiotics. In a study involving 1,800 blood cultures done on 904 patients at the University of Nebraska Medical Center (UNMC), use of the device was attributed to an 88% reduction in the blood culture contamination rate.

Developed by Magnolia Medical Technologies, the SteriPath Initial Specimen Diversion Device (ISDD) is compatible with standard BD and bioMérieux blood collection tubes and culture bottles, and has been approved by the US Food and Drug Administration (FDA) for marketing in the United States.

According to a press release by researchers at UNMC who studied the device, “With traditional blood draws, about 30% to 40% of patients with contaminated blood cultures are prescribed antibiotics unnecessarily. This contributes to antibiotic resistance and undermines nationwide efforts to improve antimicrobial stewardship.” The researchers reported their findings in an article published in the Oxford Academic journal Clinical Infectious Diseases (CID).

Blood Culture Contamination Harms Patients and Increases Cost of Care

The UNMC researchers noted that, during a blood draw, a significant percentage of blood cultures become contaminated when skin fragments containing bacteria are dislodged and mix with the patient’s blood. For the thousands of patients each day who have their blood drawn, contaminated blood cultures, which lead to false positive results for sepsis, often result in unnecessary antibiotic treatment. This in turn can lead to serious and deadly antibiotic-resistant infections with various multi-drug-resistant organisms such as Clostridium difficile infection (C. diff), as well as, other hospital-acquired infections and conditions (HAIs & HACs) due to unnecessary extended length of stay, according to Mark Rupp, MD, Professor, Department of Internal Medicine, Section of Infectious Diseases, and Medical Director, Department of Healthcare Epidemiology-Infection Control at UNMC.

In the CID article, Rupp and colleagues reported on a prospective, controlled trial conducted in the emergency department (ED) at UNMC’s partner hospital Nebraska Medicine. Results of the trial showed that the SteriPath ISDD diverts and sequesters the first 1.5 to 2 mL portion of blood. The researchers presumed that these initial drops of blood would contain the contaminating skin cells and microbes.

SteriPath is a self-contained, preassembled, sterile blood collection system. It provides proprietary vein-to-bottle technology that significantly reduces blood culture contamination, according to Magnolia Medical Technologies. This could be useful for helping phlebotomists and clinical laboratories improve the quality of specimens collected for use in blood culture testing. Click on the image above to view videos on the SteriPath ISDD. (Photo copyright: Magnolia Medical Technologies.)

The researchers tested the SteriPath ISDD during standard phlebotomy procedures in patients requiring blood cultures. After drawing 1,808 blood cultures from 904 study subjects, the researchers concluded that the ISDD significantly reduced blood culture contamination compared with standard phlebotomy procedures. The blood culture contamination among phlebotomists who used the ISDD decreased by nearly 90%, compared to phlebotomy procedures conducted by nurses who did not use the ISDD.

“We were able to decrease the false positive rate significantly through use of this device—from 1.78% down to 0.2%, which represents an 88% reduction,” Rupp noted in the UNMC press release. “The 1.78% baseline rate of contamination may seem small, but we should strive to decrease adverse events to the lowest possible level, because of the impact to the patient and the burden to our healthcare system.

“The device is innovative in that it diverts the first couple of milliliters of blood into the sequestration chamber,” Rupp explained. “That’s where we think the contaminants are. The remaining blood being drawn is then diverted into the sterile pathway into the blood culture vial, thereby preventing the contamination.”

Billions of Healthcare Dollars Could Be Saved with SteriPath’s ISDD

During a conference call with reporters, Rupp admitted that cynics might scoff at such a low rate of improvement. “Many of those folks don’t understand that we do tens of millions of blood cultures in this country every year,” he explained. “Every year, we do about 30 million or so blood cultures. That many cultures means a 2% contamination rate equates to somewhere in the neighborhood of about 600,000 contamination events. And 2% is a very respectable level. Usually clinicians are satisfied anywhere below about 3%, which is about 900,000 events each year.”

For about 40% to 50% of patients whose blood is contaminated, physicians will prescribe antibiotics, order another blood test, and require patients to stay several days in the hospital, he added. “All of this results in thousands of extra dollars being spent,” he declared. If each blood contamination case costs about $4,000, then reducing such contamination in potentially 600,000 cases each year could save more than $1 billion healthcare dollars.

According to the researchers, costs associated with blood culture contamination ranged from $1,000 per patient in 1998 to $8,700 per patient in 2009. “If a midpoint cost estimate of $4,850 is used, and the added cost of the device is not taken into account, it equates to a cost avoidance of $1.8 million per year at our institution alone,” Rupp stated. “If the low rate of contamination that we observed in the study, 0.22%, was applied to all blood cultures throughout the country, billions of dollars of excess costs could be avoided.”

This clinical study offers strong evidence that the SteriPath ISDD might prove to be a useful tool that clinical laboratories could use to help prevent unnecessary exposure to antibiotics and hospital stays, lower healthcare costs, and improve patient test outcomes. If the UNMC clinical study outcomes are replicated in future studies, then it is a technology and a solution that has the potential to be adopted by phlebotomists in medical laboratories and hospitals.

—Joseph Burns

 

Related Information:

Reduction in Blood Culture Contamination Through Use of Initial Specimen Diversion Device

Study Shows Device Reduces Blood Draw Contamination

Novel Device Significantly Reduces Blood Draw Contamination, Reduces Risks to Patients, Study Shows

Better Care by Reducing Blood Culture Contamination: Sepsis, SteriPath and Antimicrobial Stewardship

Study by Mark Rupp, MD, in Clinical Infectious Diseases: Reduction in Blood Culture Contamination Through Use of Initial Specimen Diversion Device (SteriPath)

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