The CAP is meeting with various stakeholders regarding the recent shortage of blood culture media bottles and serve as a resource in providing best practices for laboratories to ensure patients receive quality care and service they need. The CAP sent an alert to all CAP-accredited laboratories advising them of the disruption and provided additional resources on the CAP website.

The Centers for Medicare & Medicaid Services (CMS) relayed to the CAP the following guidance managing shortages:

• If the manufacturer extends the expiration date for the blood culture bottles, no additional studies will be required by CLIA in laboratories using the BD BACTEC test, and the test can be relied upon to be accurate.

• The use of expired reagents would be considered a test modification and would require the laboratory to establish performance specifications for a modified procedure. In addition, the test would default to high complexity.

• Laboratories that have previously used glass blood culture bottles and have their historic performance specification study will not be required to perform any additional studies when the glass bottles are released.

This follows the Centers for Disease Control and Prevention (CDC) issuing a health advisory about a critical shortage and an announcement by the Food and Drug Administration (FDA) regarding the disruption in availability of Becton Dickinson (BD) BACTEC™ blood culture media bottles on July 10.

The CDC said those affected by this shortage should immediately begin to assess their situations and develop plans and options to mitigate the potential impact of the shortage on patient care. They recommended instituting best practices to reduce unnecessary blood cultures and, when needed, contamination events or instances in which an inadequate blood volume is cultured. Ensuring the right samples are collected from the right patients, the right way the first time, could help mitigate negative impacts of the shortage.

Additional recommendations for laboratory professionals include:

• Determine the type of blood culture bottles your laboratory or facility uses and whether this shortage will impact you.
• Implement practices to optimize the use of blood cultures at your facility. Doing so may be helpful even for facilities not affected by the shortage.
• Take steps to prevent blood culture contamination. Contamination can negatively affect patient care and may require the collection of more blood cultures to help determine whether contamination has occurred.
• Ensure that the appropriate volume is collected when collecting blood for culture. Underfilling bottles decreases the sensitivity to detect bacteremia/fungemia and may require additional blood cultures to be drawn to diagnose an infection.
• If your laboratory or facility will be impacted by the bottle shortage, determine whether you have alternative options for blood cultures (eg, working with a nearby facility or sending samples out to a laboratory not affected by the shortage).
• Monitor current and future supplies of blood culture bottles at your laboratory or facility and report any potential shortages or interruptions to the FDA.
• If your facility will be impacted by the bottle shortage, convene a group of local laboratory and clinical experts to determine how a limited supply of blood culture bottles will be prioritized for use in your facility.

Additional Resources:

• CDC Health Advisory
• Medical Device Shortages List | FDA