Form 57.109 Becton Dickinson BACTECTM Blood Culture Media Bottles Sh

F orm Approved

OMB No.

Exp. Date: XX/XX/XXXX

www.cdc.gov/nhsn

Becton Dickinson BACTEC^TM Blood Culture Media Bottles Shortage

Impact Questionnaire

Background: The FDA announced supply interruptions for BD BACTEC^TM blood culture media bottles due to supplier issues, impacting patient diagnosis, follow-up care, and antimicrobial stewardship efforts. Facilities and healthcare providers are advised to conserve the supply for high-risk patients.

More Information:

• FDA’s Disruptions in Availability of BD BACTEC Blood Culture Media Bottles - Letter to Health Care Providers

• CDC’s Disruptions in Availability of BD BACTEC Blood Culture Bottles: Current Situation

Purpose of this Questionnaire:

This inquiry aims to assess the shortage's impact on facilities and bloodstream infection surveillance.

Please answer the following questions regarding the impact on your facility:

1. Did your facility use the BD BACTEC™ Blood Culture System anytime during the potential shortage during 2024? Yes/No

2. Was your facility impacted by the shortage of BD BACTEC™ blood culture media bottles? Yes/No

   1. If yes, indicate which of the following blood culture bottles were impacted? (check all that apply)

	Product Name
	BD BACTEC™ Peds PlusTM/F Culture Vials
	BD BACTEC™ Lytic/10 Anaerobic/F Culture Vials
	BD BACTEC™ Plus Anaerobic/F Culture Vials
	BD BACTEC™ Plus Aerobic/F Culture Vials
	BD BACTEC™ Standard Anaerobic/F Culture Vials
	BD BACTEC™ Standard/10 Aerobic/F Culture Vials
	BD BACTEC™ Myco/F Lytic Culture Vials

Assurance of Confidentiality:  The voluntarily provided information obtained in this surveillance system that would permit identification of any individual or institution is collected with a guarantee that it will be held in strict confidence, will be used only for the purposes stated, and will not otherwise be disclosed or released without the consent of the individual, or the institution in accordance with Sections 304, 306 and 308(d) of the Public Health Service Act (42 USC 242b, 242k, and 242m(d)).

Public reporting burden of this collection of information is estimated to average 20 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering, and maintaining the data needed, and completing and reviewing the collection of information.  An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.  Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC, Reports Clearance Officer, 1600 Clifton Rd., MS H21-8, Atlanta, GA 30333, ATTN:  PRA (0920-XXXX).

3. During the specified month, what was your facility’s lowest supply of blood culture media bottles (in days on hand)?

Product Name	Days on Hand per Month
	Prior to the Shortage	November	December	January	February	March
BD BACTEC™ Plus Aerobic/F Culture Vials
BD BACTEC™ Lytic/10 Anaerobic/F Culture Vials
BD BACTEC™ Peds PlusTM/F Culture Vials
BD BACTEC™ Plus Anaerobic/F Culture Vials
BD BACTEC™ Standard Anaerobic/F Culture Vials
BD BACTEC™ Standard/10 Aerobic/F Culture Vials
BD BACTEC™ Myco/F Lytic Culture Vials

4. Did your facility implement a plan to mitigate the impact of the blood culture bottle shortage? Yes/No

1. If Yes, which of the following strategies were included? (Check all that apply)

Strategy Implemented	Yes/No	Month Started	Month Stopped
Collaboration with Other Facilities
Partnering with a nearby facility or sending samples out to a laboratory not affected by the shortage
Diversification of Diagnostic Resources
Using non-culture-based microbiology testing (NCT)
Purchasing another blood culture system/instrument
Developing a new internal process to culture blood samples (for example, manual blood cultures)
Extended Collection Intervals
Increasing the recommended timeframe between blood culture collection
Extended Use
Using expired blood culture bottles (beyond the parameters set forth by the manufacturer)
Inventory Management Adjustments
Limiting or encouraging the use of a single set (1 aerobic and 1 anaerobic bottle)
Limiting or encouraging the use of a single aerobic bottle
Limiting or encouraging the use of a single anaerobic bottle
Using a bottle for a purpose other than its intended function (for example, using pediatric bottles for adult patients or vice versa; using anaerobic bottle for aerobic by venting the bottle)
Prioritization of Critical Cases
Prioritizing certain populations (for example, high-risk or critical patients)
Implementing a triage system to determine which cases require blood cultures and which can be managed without them
Other, Specify

5. In the table below, indicate the impact of the blood culture bottle shortage and the mitigation strategies implemented by your facility by month.

Impact of Blood Culture Bottle Shortage and Mitigation Strategy Implementation	Jun	Jul	Aug	Sep	Oct
To what extent did the blood culture bottle shortage impact your facility's ability to maintain inventory at or above the established Periodic Automatic Replenishment (PAR) level? (Select one of the options below for each month)
No Impact: Our facility consistently maintained inventory at or above PAR level.
Minor Impact: Our facility occasionally fell below PAR level but were recovered quickly.
Moderate Impact: Our facility frequently fell below PAR level, affecting routine operations.
Severe Impact: Our facility was unable to maintain inventory at PAR level, leading to significant disruptions in patient care.
For the months your facility indicated the impact was Minor, Moderate, or Severe to the facility’s blood culture bottle inventory due to the shortage what was the impact on your facility’s standard practice for blood culture bottle use? (Select one of the options below for each month)
No Change: Our facility maintained standard practices for blood culture bottle use without any adjustments.
Slight Adjustment: Minor changes were made to blood culture bottle use.
Moderate Adjustment: Noticeable changes were made to blood culture bottle use.
Significant Adjustment: Major modifications were made to blood culture bottle use.
Severe Adjustment: Drastic changes were made to blood culture bottle use.

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