The United States is currently experiencing a shortage of blood culture bottles, particularly the BD BACTEC blood culture media bottles. This shortage, which began in early July 2024, is due to supply chain issues faced by the manufacturer Becton Dickinson (BD). The shortage has raised significant concerns among healthcare providers and federal agencies, as it can impact the diagnosis and management of patients, especially those with bloodstream infections.
Both the CDC and FDA have issued warnings about the potential disruptions in patient care, including delays in diagnosis and misdiagnosis due to the shortage. Hospitals and laboratories are being urged to prioritize the use of available bottles for the most critical cases and to adopt conservation strategies.
Efforts are being made to manage the situation and information is changing rapidly. ASM, FDA, CDC, AHVAP, and IDSA have all provided documents to update the status of the supply interruption and documents to support blood culture collection.
The consistent message from all groups has been to prioritize three actions:
- Optimize ordering of blood cultures
- Prevent contaminated blood culture
- Ensure appropriate blood volume
To prevent contaminated blood cultures, review collection best practice guidance in these Centers for Disease Control & Prevention (CDC) Resources:
- Blood Culture Contamination: An Overview for Infection Control and Antibiotic Stewardship Programs Working with the Clinical Laboratory
- Preventing Adult Blood Culture Contamination: A Quality Tool for Clinical Laboratory Professionals
- Diagnostic Excellence: A New Quality Tool to Prevent Blood Culture Contamination
For more guidance, contact a Kurin Clinical Outcomes Team Member for more information on blood culture bottle preservation at 1-888-963-9056 or cs@kurin.com.
More about the Blood Culture Bottle Shortage
Guidance Documents:
Statements:
- Food and Drug Administration (FDA) Letter to Health Care Providers
- FDA Medical Device Shortages List
- Centers for Disease Control & Prevention (CDC)
- Centers for Medicare and Medicaid Services (CMS)
- Department of Health & Human Services
- Infectious Disease Society of America (IDSA)
- Becton Dickenson (BD)
Journal Articles:
- Every Crisis is an Opportunity: Advancing Blood Culture Stewardship During a Blood Culture Bottle Shortage
- Rapid Implementation of Blood Culture Stewardship: Institutional Response to an Acute National Blood Culture Bottle Shortage
- Does This Patient Need Blood Cultures? A Scoping Review of Indications for Blood Cultures in Adult Nonneutropenic Inpatients
Blood Culture Collection Guidelines & References
Centers for Disease Control and Prevention
Blood Culture Contamination: An Overview for Infection Control and Antibiotic Stewardship Programs Working with the Clinical Laboratory
In offering guidance, the CDC references a study by Doern et al which identifies ways to address blood culture contamination. Among the preventive actions, the authors call for the use of diversion devices saying, “There are devices that are commercially available that have shown promise in further reducing blood culture contamination rates. These devices initially divert a small amount of potentially contaminated blood and then collect blood for the blood culture.”
Read the full guidance: Blood Culture Contamination: An Overview for Infection Control and Antibiotic Stewardship Programs Working with the Clinical Laboratory
Centers for Medicare and Medicaid (CMS)
Published a final rule 42 C.F.R § 482.42
Since early 2020, the CMS Conditions of Participation has required hospitals to “demonstrate adherence to nationally recognized infection prevention and control guidelines for reducing the transmission of infections, as well as best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic-resistant organisms.”
CMS Compliance will require:
- A hospital’s infection prevention and control and antibiotic stewardship programs be active and hospital-wide for the surveillance, prevention, and control of [hospital acquired infections] and other infectious diseases.
- Optimization of antibiotic use through stewardship.
Clinical and Laboratory Standards Institute (CLSI®)
Wilson, ML. Principles and Procedures for Blood Cultures, 2nd Edition.
CLSI Document M47Ed2E (ISBN Number: 978-1-68440-149-9) 2022
Infusion Nursing Society
Infusion Therapy Standards of Practice, 9th Edition
Nickel B, Gorski L; Kleidon T, et al. Journal of Infusion Nursing. 47(1S):S1-S285, January/February 2024.
Section 41. Blood Sampling. Practice Recommendations. Section I, Comment G, Part C, recommends: Consider the costs and benefits in implementing a consistent process to divert and discard the initial blood sample when drawing blood cultures. Studies have demonstrated reduction in blood culture contamination with use of a diversion device.”
Infectious Diseases Society of America (IDSA)
Guide to Utilization of the Microbiology Laboratory for Diagnosis of Infectious Diseases: 2024 Update by the Infectious Diseases Society of America (IDSA) and the American Society for Microbiology (ASM).
BLOODSTREAM INFECTIONS AND INFECTIONS OF THE CARDIOVASCULAR SYSTEM (pg 6)
To minimize the risk of contamination of the blood culture with commensal skin microbiota, meticulous care should be taken in skin preparation prior to venipuncture. In addition, products are available that allow diversion and discard of the first few milliliters of blood that are most likely to contain skin contaminant.
American Society for Microbiology
Amy L. Leber. 2016. Blood Cultures, p 151-182. In Clinical Microbiology Procedures Handbook, 3rd Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817435.ch3.4
Emergency Nurses Association (ENA)
ENA Emergency Nursing Resources Development Committee. Clinical practice guideline: prevention of blood culture contamination. Emergency Nurses Association; 2012 Dec.
Recommendation 13. Divert the initial 1–2 ml of blood into a sterile receptacle when drawing blood culture specimens via peripheral venipuncture. Level B – Moderate (Patton & Schmitt, 2010) (Note: New evidence is pending. When it is available, this recommendation will be updated if indicated.)
College of American Pathologists (CAP)
CAP 2018 Q-Tracks: MIC.22630
“It is recommended that blood culture statistics, including number of contaminated cultures, be maintained and reviewed regularly by the laboratory director. The laboratory should establish a threshold for an acceptable rate of contamination. Tracking the contamination rate and providing feedback to phlebotomists or other persons drawing cultures has been shown to reduce contamination rates.”
ML-019 Rev F