The National Quality Forum (NQF) Endorses Centers for Disease Control and Prevention’s (CDC) New Blood Culture Contamination Quality Measure

The CDC Quality Measure calls for a common, consistent standard for all U.S. hospitals to follow for calculating, monitoring, and reporting blood culture contamination rates with the goal of minimizing false-positive sepsis test results to prevent patient harm and improve patient outcomes

Seattle – February 8, 2023 – Magnolia Medical Technologies, Inc. (“Magnolia Medical”), inventors of the Steripath^® Initial Specimen Diversion Device^® (ISDD^®) family of products, today commended the NQF Consensus Standards Approval Committee (CSAC) for its formal endorsement of the new CDC Quality Measure 3658, entitled: Adult Blood Culture Contamination Rate; A national measure and standard for clinical laboratories and antibiotic stewardship programs.¹

This new Patient Safety Measure, independently developed and submitted by the Centers for Disease Control and Prevention (CDC) for consideration in April 2022 and formally endorsed by NQF in December 2022, will play an integral role in increasing the transparency of blood culture contamination and sepsis testing accuracy performance at U.S. hospitals and healthcare systems.

The NQF’s recent endorsement of this important new measure reflects the diagnostic significance of blood cultures in the detection of bloodstream infections, including sepsis. The planned use of this measure is to support hospital-specific quality improvement projects, public reporting, and regulatory and accreditation programs associated with the suspected sepsis patient population.

Blood culture is one of the most clinically important and frequently performed diagnostic tests in U.S. hospitals; however, in a typical hospital, as many as half of positive blood culture results are false-positive due to contamination.^2,3 These false-positive results negatively impact patient safety and care quality, leading to an increased risk of unnecessary and prolonged broad-spectrum antibiotic exposure, acute kidney injury, C. difficile, and other multidrug-resistant organism infections. Patients with false-positive results are also unnecessarily subjected to the risk of  extended hospital stay, significant avoidable hospital costs, and as much as a 74 percent increase in in-hospital patient mortality.⁴

One of the express goals of this national quality measure is to improve and standardize blood culture quality and safety performance for all hospitals in the U.S. According to NQF, “Low contamination rates result in appropriate and optimal use of antibiotics which reduces adverse patient events such as overuse of antibiotics, increased exposure to hospital-acquired infections like Clostridium difficile colitis, development of antibiotic-resistant bacteria, and extended length of hospital stay.”¹

“For over a decade, Magnolia Medical has been on a collective mission with hospitals and healthcare systems to implement evidence-based technologies and best practice education to reduce blood culture contamination in the pursuit of eliminating sepsis misdiagnosis,” said Greg Bullington, CEO and Co-founder of Magnolia Medical.

“We are thrilled with this significant advancement of the standard of care by CDC and NQF given the importance of blood culture accuracy on patient safety and quality of care. Standardizing how blood culture contamination is defined, tracked, monitored, and reported will benefit millions of patients and save our healthcare system billions of dollars under the new standard of care. With the endorsement of this measure, NQF has laid the foundation for the Centers for Medicare & Medicaid Services (CMS) to integrate this new quality measure into the Hospital Inpatient Public Quality Reporting Program in the best interest of patient safety and outcomes,” concluded Bullington.

Recently, the Clinical and Laboratory Standards Institute (CLSI), a national organization that develops and sets standards for laboratory quality and performance, established a new goal of 1% or below blood culture contamination rate with the use of best practices.⁵

Additionally, the 2022 CDC Guidelines, Blood Culture Contamination: An Overview of Infection Control and Antibiotic Stewardship Programs Working with the Laboratory, which were in coordination with their submission of the NQF Patient Safety Measure, reinforce the CLSI goal stating, “when best practices are followed, a target contamination rate of 1% is achievable. Such thresholds can provide a method to benchmark within or between facilities.” The CDC Guidelines also provided eight evidence-based practices for reducing blood culture contamination rates, including the use of Initial Specimen Diversion Devices^® that divert the initial 1 to 2 mL of potentially contaminated blood prior to blood collection.^6,7

About Steripath

The Steripath^® Initial Specimen Diversion Device^® is the only FDA 510(k)-cleared device platform specifically indicated to reduce blood culture contamination and offers the only all-in-one devices that are designed and clinically proven to meet the ENA, INS, CDC, and CLSI evidence-based best practice guidelines to reduce blood culture contamination.^5,6,7,8,9,10 To date, 20 clinical studies have been completed supporting the clinical and cost effectiveness of Steripath. All studies reported sustained contamination rates of 0-1% using Steripath, up to a 31% reduction in vancomycin days of therapy, and as much as a 12-fold decrease in false-positive central line-associated blood stream infections (CLABSIs) over extended periods of time.^11,12,13

Steripath has been adopted by hundreds of U.S. hospitals and healthcare systems to address the problem of blood culture contamination, which can lead to sepsis misdiagnosis resulting in unnecessary, prolonged, and harmful antibiotic treatment, extended length of hospital stay, false-positive CLABSIs, and wasted healthcare resources.

About Magnolia Medical Technologies

Magnolia Medical Technologies develops, manufactures, and markets innovative blood and bodily fluid collection devices to facilitate significant improvements in the accuracy, consistency, and predictability of critical laboratory tests. Magnolia Medical invented and patented the Initial Specimen Diversion Technique^® (ISDT^®) and Initial Specimen Diversion Device^® (ISDD^®) for blood culture collection and contamination prevention. The company has amassed an intellectual property portfolio, including more than 130 issued method, apparatus, and design patents with more than 50 additional patent applications pending. For more information, visit www.magnolia-medical.com.

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Contact:

Bob Gerberich
Chief Commercial Officer
[email protected]

 

1. Quality Positioning System (QPS) Measure Description Display Information; 2022. Retrieved from https://www.qualityforum.org/QPS.
2. Principles and Procedures for Blood Cultures; Approved Guidelines. CLSI document M47-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2007.
3. Zwang O, Albert RK. Analysis of strategies to improve cost effectiveness of blood cultures. J Hosp Med. 2006;1(5):272-6. doi:10.1002/jhm.115.
4. Klucher J, Davis K, Lakkad M, Painter JT, Dare RK. Risk factors and clinical outcomes associated with blood culture contamination. Infect Control Hosp Epidemiol. 2022;43(3):291-297. doi:10.1017/ice.2021.111.
5. Principles and Procedures for Blood Cultures. 2nd Ed. CLSI Guideline M47. Clinical and Laboratory Standards Institute; 2022.
6. Blood Culture Contamination Prevention Actions: An Overview of Infection Control and Antibiotic Stewardship Programs Working with the Clinical Laboratory. July 2022.
7. CDC National Email Update to Clinicians. Clinicians: Use this guide to decrease blood culture contamination rates. July 22, 2022.
8. Indicated for use as a blood collection system that diverts and sequesters the initial specimen prior to collection of a subsequent test sample to reduce the frequency of blood culture contamination when contaminants are present in the initial blood sample compared to blood cultures drawn with standard procedure without manual diversion.
9. Vanhoy MA, Horigan A, Kaiser J, et al. Emergency Nurses Association (ENA). Clinical practice guideline: prevention of blood culture contamination. 2020.
10. Gorski LA, Hadaway L, Hagle ME, et al. Infusion therapy standards of practice, 8th edition. J Infus Nurs. 2021 Jan-Feb 01;44(1S Suppl 1): S1-S224.doi: 10.1097/NAN.0000000000000396.
11. Date on file.
12. Nielsen LE, Nguyen K, Wahl CK, et al. Initial Specimen Diversion Device^® reduces blood culture contamination and vancomycin use in academic medical center. J Hosp Infect. 2021;117. doi:https://doi.org/10.1016/j.jhin.2021.10.017.
13. Tompkins LS, Tien V, Madison AN. Getting to zero: impact of a device to reduce blood culture contamination and false-positive central line-associated blood stream infections. Infect Control Hosp Epidemiol. 2022;1-5. doi:10.1017/ice.2022.284.

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