Interim Guidance on BD BACTEC™ Blood Culture Media Bottle Shortage and Laboratory Verification Practices
Guidance for clinical laboratories and health care providers on managing disruptions in the supply of BD BACTEC™ blood culture media bottles, use of expired bottles, and verification when switching to BD glass bottles; applies to laboratories regulated under CLIA.
No material clinical or coverage changes in this revision.
Coverage Criteria
The CLIA regulation at 42 C.F.R. § 493.1252(d) prohibits the use of reagents, solutions, culture media, control materials, calibration materials, and other supplies that have exceeded their expiration date, have deteriorated, or are of substandard quality unless appropriate extensions or verifications are in place. During the BD BACTEC™ blood culture media shortage, BD has issued specific lot-based extended shelf-life notifications; laboratories should contact BD for information about which lots are covered and must treat any lots without an extension as expired per CLIA. If a laboratory uses expired materials without an approved extension or verification, that use is considered a modification of the test and invokes regulatory requirements for establishing performance specifications and reporting the test as high complexity.
Blood culture testing when BD BACTEC media are available — prioritization during shortages
Prioritize available BD BACTEC™ blood culture media based on clinical need during supply shortages. Covered when ALL of the following criteria are met:
ALL of the following
Clinical priority
- Specimen collected from a patient with suspected bloodstream infection or sepsis, or other high‑acuity condition where timely blood culture results will directly affect immediate clinical management (e.g., initiation, escalation, or de‑escalation of antimicrobial therapy).
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