The Impact of a Nationwide Blood Culture Bottle Shortage in 2024 on Healthcare Facilities in the United States

Abstract

Background:

A shortage of BD BACTEC^™ blood culture bottles occurred in 2024. We describe the clinical impact of that shortage.

Methods:

We conducted a National Healthcare Safety Network (NHSN) questionnaire and retrospective cohort study using inpatient hospitalization data from the Premier Healthcare Database. In the retrospective cohort, facilities were categorized into BD BACTEC^™ (n=11) and non-BD BACTEC^™ (n=28) hospitals; non-shortage and shortage periods were considered from May 2023 to June 2024 and July to November 2024. We used a generalized linear model for the rate of blood cultures with an offset for patient days and adjusted for facility characteristics and other factors. Similarly, we modeled the rate of unique adult hospitalizations with a pathogen-positive blood culture per hospitalization.

Results:

Of 3,196 facilities responding, 1,456 (45.6%) indicated a use of BD BACTEC^™ to the NHSN questionnaire; of those, 1,103 (75.8%) reported a shortage impact. In the retrospective cohort study, there was a 27.4% decrease in cultures at BD BACTEC^™ hospitals during the shortage period (95% CI: −31.2% to −23.4%). BD BACTEC^™ facilities had a median change in culturing rate of −33.3% (IQR: −47.0% to 2.0%) between the non-shortage and shortage periods. There was a 15.3% decrease in the rate of patients positive for a pathogen at affected facilities during the shortage (95% CI: −22.4% to −7.5%).

Conclusions:

BD BACTEC^™ facilities experienced substantial and non-uniform decreases in blood culture rates. Impacted facilities had a decrease in the rate of observed bloodstream infections, which has implications for patient safety and surveillance.

Background

Blood cultures are critical tools for the diagnosis of bloodstream infections (BSI) including sepsis, catheter-related BSIs, and infective endocarditis [1–5]. For adults with suspected sepsis, guidelines recommend collecting two or three blood culture sets including 20–30 mL of blood per set, which improves sensitivity compared to lower volumes [5–7]. There are multiple commercially available automated blood culture systems, and each system uses unique blood culture vials. The two most widely used systems in the United States are the BACT/ALERT^® (BioMérieux, Inc., Durham, NC) and BD BACTEC^™ (Becton Dickinson Diagnostic Systems, Sparks, MD) [8]. Approximately 50% of facilities in the United States use Becton Dickinson (BD) blood culture vials [9].

On June 11, 2024, BD Life Sciences released a letter to BD BACTEC^™ blood culture system users alerting of possible delays in the supply of BD BACTEC^™ blood culture vials [10]. On July 10, 2024, the U.S. Food and Drug Administration issued a letter describing the shortage and encouraging conservation strategies [11]. On July 23, 2024, the Centers for Disease Control and Prevention issued a Health Alert Network Health Advisory about the critical shortage in BD BACTEC^™ blood culture vials and recommending mitigation actions [12]. The extent and impact of the shortage have not yet been described in multicenter studies. We summarize the data from a National Healthcare Safety Network (NHSN) questionnaire assessing the shortage’s impact and severity and used the Premier Healthcare Database (PHD) to quantify the impacts on blood culture utilization and BSI detection.

Methods

National Healthcare Safety Network Questionnaire

NHSN launched a voluntary questionnaire on December 14, 2024, to facilities enrolled in the Patient Safety Component (PSC) (Supplemental Table S1). Inpatient Psychiatric Hospitals and Ambulatory Surgery Centers enrolled in the PSC were excluded. This questionnaire evaluated the disruption severity, operational strains, and patient care implications. The questionnaire included information on inventory, mitigation strategies, and overall impact [13]. Facilities self-reported their inventory levels from June to October 2024, along with mitigation strategies they employed and the impact on standard practices for blood culture bottle usage. Data entry for the questionnaire stopped on February 28, 2025. We analyzed responses to assess the proportion of U.S. healthcare facilities impacted and shortage severity.

Premier Healthcare Database Retrospective Cohort Study

We conducted a retrospective cohort study using inpatient hospitalization data from PHD from May 1, 2023, to November 30, 2024 [14]. Blood specimens were identified in the PHD microbiology laboratory data using SNOMED codes as classified by NHSN’s Antimicrobial Use and Resistance module (Supplemental Table S2). Only a subset of facilities submitting to PHD include microbiology laboratory data. Among blood specimens, only lab tests indicative of a culture were included (Supplemental Table S3). Premier, Inc. provided purchase order data between January 1, 2023, and June 30, 2024. Facilities were categorized as those only purchasing BD BACTEC^™ blood culture vials, termed BD BACTEC^™ hospitals, and those only purchasing other manufacturer blood culture vials, termed non-BD BACTEC^™ hospitals. Facilities purchasing both BD BACTEC^™ and other manufacturer blood culture vials were excluded (Supplemental Table S4). Facilities reporting more than five inpatient blood cultures per month during all study months were included. We removed facility months with incomplete culture or hospitalization data or outliers after reviewing median absolute deviation ratios. For the primary analyses, cultures from pediatric patients (age <18) were excluded, although we conducted a subgroup analysis of pediatric cultures. Blood cultures were included if they occurred up to 3 days before admission, during hospitalization, or up to 3 days after discharge. Cultures containing only a “preliminary” result were excluded. The non-shortage period was considered May 1, 2023, to June 30, 2024. The shortage period was considered July 1, 2024 to November 30, 2024.

Blood Culture Definitions

The PHD includes a specimen number to identify unique blood cultures but does not include the number of bottles utilized for each culture. Solitary blood cultures were defined as single unique blood culture collected in a 24-hour period (i.e., no other blood cultures collected within +/− 24 hours). The microbes identified in positive blood cultures were categorized as common commensals or pathogens using the NHSN organism list [15]. If the identified microbe was not in the NHSN organism list, a medical officer (JDL) classified the organism as a common commensal or pathogen (<1% of all positive blood cultures). Admission cultures were defined as occurring on or before day 3 of hospitalization, and post-admission cultures were obtained on day 4 or later of the hospitalization. Cultures were categorized as intensive care unit (ICU) if the culture was collected on the same day the patient had a hospital charge for an ICU stay, excluding psychiatric ICUs; cultures collected on a day of hospitalization without an ICU charge were non-ICU. Rates were calculated as cultures per 1,000 patient days for overall, post-admission, ICU, and non-ICU cultures; admission culture rates were calculated as cultures per 1000 hospitalizations. We also calculated the rate of adult hospitalizations with any pathogen positive blood culture per 1,000 hospitalizations, and pathogen-specific positive blood culture rates for the most commonly observed pathogens: Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae complex, Enterococcus faecalis, Proteus mirabilis, Streptococcus pneumoniae, Pseudomonas aeruginosa, and Streptococcus pyogenes.

Modeling

To examine the impact of the shortage, we used a generalized linear model assuming a negative binomial distribution for blood cultures with an offset for either patient days or hospitalizations. We adjusted our model for facility characteristics (teaching status, facility number of beds, urban/rural designation, U.S. census region, and percent of patient days in the ICU), season (winter, spring, summer, fall), time by month (included as a continuous variable), and a random intercept for facility identifier. We created an indicator variable for the shortage representing months in BD BACTEC^™ facilities from July 2024 through November 2024. In addition, we used another generalized linear model assuming a negative binomial distribution for the rate of adult hospitalizations with a pathogen-positive blood culture per hospitalization.

This activity was reviewed by CDC and was consistent with applicable federal law and CDC policy (see eg, 45 C.F.R. part 46, 21 C.F.R. part 56; 42 U.S.C. §241(d); 5 U.S.C. §552a; 44 U.S.C. §3501 et seq). Data management and analyses were conducted using SAS version 9.4, Python 3.8.10 on the Microsoft Azure Databricks platform, and R version 4.4.0.

Results

National Healthcare Safety Network Questionnaire

Of 6,192 facilities (Supplemental Table S1) enrolled in the PSC, 3,196 (51.6%) completed the questionnaire, with 1,456 (45.6%) facilities reporting using the BD BACTEC^™ Blood Culture System. Among these, 1,103 facilities (75.8%) indicated a change in blood culturing practices due to the shortage. In June, 242 BD BACTEC^™ facilities (21.9%) reported a moderate or severe impact of the shortage on inventory maintenance; this peaked in August 2024 when 591 facilities (53.6%) reported a moderate or severe impact (Supplemental Table S5). Among BD BACTEC^™ facilities reporting an impact, 1,064 (96.5%) implemented strategies to mitigate the effects. Strategies included limiting to or encouraging the use of single-set collection (one aerobic and one anaerobic bottle) (736 facilities, 69.2%), prioritization of certain patient populations (e.g., high-risk or critical patients) (609 facilities, 57.2%), and implementation of a triage algorithm to determine which situations necessitated blood cultures (473 facilities, 44.5%) (Supplemental Table S6).

Premier Healthcare Database Retrospective Cohort Study

After exclusions, there were 137,588 adult hospitalizations with 326,770 unique adult blood cultures included in our study (Supplemental Figure 1). The primary reason for facilities to be excluded was lack of blood culture bottle type data (134 facilities) followed by the facility not consistently reporting >5 blood cultures per month during the study timeframe (52 facilities). Our study included 11 BD BACTEC^™ and 28 non-BD BACTEC^™ facilities. Most facilities were non-teaching (69.2%), urban (71.8%), and <300 beds (71.8%) (Table 1). A majority of BD BACTEC^™ facilities were from the Northeast (63.6%), while most non-BD BACTEC^™ facilities were from the South U.S. Census region (57.1%). The shortage period contributed 26.1% of all the patient days in the cohort. ICU patient days contributed 11.0% of the patient days in the cohort (Table 1).

Table 1:

Facilities in the Premier Healthcare Database Study Cohort, May 2023 to November 2024

	BDa BACTEC™ Blood Culture Vial Facilities	Non-BDa BACTEC™ Blood Culture Vial Facilities
Number of Facilities	11	28
Teaching Status
Teaching	4 (36.4%)	8 (28.6%)
Non-Teaching	7 (63.6%)	20 (71.4%)
Facility Number of Bedsb
Facility with <300 Beds	9 (81.8%)	19 (67.9%)
Facility with ≥300 Beds	2 (18.2%)	9 (32.1%)
Urban/Rural Designation
Urban	7 (63.6%)	21 (75.0%)
Rural	4 (36.4%)	7 (25.0%)
U.S. Census Region
Northeast	7 (63.6%)	1 (3.6%)
Midwest	1 (9.1%)	10 (35.7%)
South	3 (27.3%)	16 (57.1%)
West	0 (0.0%)	1 (3.6%)
Hospitalizations
Non-Shortage Hospitalizationsc	92,955 (73.9%)	346,064 (73.4%)
Shortage Hospitalizationsd	32,857 (26.1%)	125,629 (26.6%)
Patient Days
Non-Shortage Patient Daysc	492,931 (74.0%)	1,717,852 (73.8%)
Shortage Patient Daysd	172,833 (26.0%)	609,330 (26.2%)
ICU Patient Days
Non-Shortage ICU Patient Daysc	51,905 (73.2%)	192,217 (74.1%)
Shortage ICU Patient Daysd	18,993 (26.8%)	67,303 (25.9%)

^aBecton Dickinson (BD);

^bFor BD BACTEC^™ facilities there were 2 facilities with 0–99 beds, 5 with 100–199 beds, 2 with 200–299 beds, and 2 with 400–499 beds. For non-BD BACTEC^™ facilities there were 10 facilities with 0–99 beds, 5 with 100–199 beds, 4 with 200–299 beds, 4 with 300–399 beds, 1 with 400–499 beds, and 4 with 500+ beds;

^cNon-Shortage defined as May 2023 to June 2024;

^dShortage defined as July to November 2024

Blood Culture Utilization in Premier Healthcare Database

The overall adult blood culture rates among BD BACTEC^™ facilities decreased between the non-shortage and shortage periods from 139.3 to 88.8 cultures per 1,000 patient days; among non-BD BACTEC^™ facilities during the non-shortage and shortage periods, there were 104.8 and 102.9 cultures per 1,000 patient days (Table 2). The largest decrease in cultures was observed between July and August 2024, and these decreases occurred among admission, post-admission, ICU, and non-ICU cultures (Figure 1). After adjusting for facility characteristics and other factors, there was a 27.4% decrease in cultures at BD BACTEC^™ hospitals during the shortage period (95% CI: −31.2% to −23.4%) (Table 3). This significant decrease in culturing rate was also observed among admission (29.3% decrease, 95% CI: −32.9 to −25.5), post-admission (26.2% decrease, 95% CI: −33.4 to −18.2), ICU (26.4% decrease, 95% CI: −31.2 to −21.3), and non-ICU cultures (28.0% decrease, 95% CI: −32.1 to −23.7). Among BD BACTEC^™ facilities, there was a median change of −33.3% between the non-shortage and shortage period. The interquartile range was −47.0% to 2.0% (Supplemental Figure 2). At non-BD BACTEC^™ facilities, there was a median change of −3.8% (IQR: −9.8% to 4.0%) (Supplemental Figure 2). In the subgroup analysis of pediatric blood cultures, the utilization rate among BD BACTEC^™ hospitals decreased from 43.6 to 35.6 cultures per 1,000 patient days between the non-shortage and shortage time periods; while blood culture rates at the non-BD BACTEC^™ hospitals in the non-shortage and shortage periods were 16.0 and 16.5, respectively.

Table 2:

Utilization of Adult Blood Cultures in the Premier Healthcare Database Study Cohort, May 2023 to November 2024

	BDa BACTEC™ Blood Culture Vial Facilities		Non-BDa BACTEC™ Blood Culture Vial Facilities
	Non-Shortageb	Shortagec	Non-Shortageb	Shortagec
Blood Cultures	68,663	15,349	180,032	62,726
Rates of Blood Cultures
Overalld	139.3	88.8	104.8	102.9
Admissione,f	617.0	388.0	442.2	429.9
Post-admissiond,g	22.9	15.1	15.7	14.3
ICUh	240.2	154.1	183.3	174.8
Non-ICUi	127.4	80.8	94.9	94.0
Number and Proportion of Patients with at Least One Culture	29,136 (31.3%)	8,446 (25.7%)	73,778 (21.3%)	26,228 (20.9%)
Number and Proportion of ICU Patients with at Least One Culturej	6,272 (47.9%)	1,923 (39.5%)	17,226 (33.4%)	5,935 (32.3%)
Number and Proportion of non-ICU Patients with at Least One Culturek	22,864 (28.6%)	6,523 (23.3%)	56,552 (19.2%)	20,293 (18.9%)
Mean Number of Cultures Per Patientl
Overall	2.4	1.8	2.4	2.4
Admissionf	2.0	1.5	2.1	2.1
Post-admissiong	0.4	0.3	0.4	0.3
Solitary Blood Cultures
Overall	1,901 (2.8%)	1,207 (7.9%)	1,363 (0.8%)	479 (0.8%)
Admissionf	806 (1.4%)	517 (4.1%)	694 (0.5%)	217 (0.4%)
Post-admissiong	1,095 (9.7%)	690 (26.5%)	669 (2.5%)	262 (3.0%)
ICU	367 (2.9%)	321 (11.0%)	376 (1.1%)	111 (0.9%)
Non-ICU	1,534 (2.7%)	886 (7.1%)	987 (0.7%)	368 (0.7%)
Initialm	538 (1.8%)	460 (5.4%)	330 (0.4%)	91 (0.3%)

^aBecton Dickinson (BD);

^bNon-Shortage defined as May 2023 to June 2024;

^cShortage defined as July to November 2024;

^dRates expressed per 1,000 patient days;

^eRates expressed per 1,000 patient hospitalizations;

^fAdmission: cultures occurred on or before day 3 of hospitalization;

^gPost-admission: cultures occurred on or after day 4 of hospitalization;

^hRates expressed per 1,000 ICU patient days;

ⁱRates expressed per 1,000 non-ICU patient days;

^jICU patients here means a patient who stayed at least one day in the ICU;

^kNon-ICU patients here means the patient did not stay in the ICU during the hospitalization;

^lAmong patients with at least one culture during the hospitalization;

^mInitial: Patient’s first culture during the hospitalization

Figure 1. Blood Culture Rates among Becton Dickinson (BD) BACTEC^™ and non-BD BACTEC^™ Facilities in the Premier Healthcare Database between May 2023 and November 2024.

Figure 1A: Overall blood culture rates per 1,000 patient days, Figure 1B: admission blood culture rates per 1,000 hospitalizations, Figure 1C: post-admission blood culture rates per 1,000 patient days, Figure 1D: Intensive care unit (ICU)and non-ICU blood culture rates per 1,000 ICU and non-ICU patient days, respectively, * BD BACTEC^™ facilities (n=11) and non-BD BACTEC^™ facilities (n=28)

Table 3:

Generalized Linear Model Assuming a Negative Binomial Distribution for the Rate of Blood Cultures in the Premier Healthcare Database, May 2023 to November 2024

	Culturesa		Admission Culturesb		Post-admission Culturesa		ICU Culturesc		Non-ICU Culturesd
	Percent Change	P-value	Percent Change	P-value	Percent Change	P-value	Percent Change	P-value	Percent Change	P-value
BDe BACTEC™ vs. non-shortage Facilitiesf	−27.4% (−31.2, −23.4)	<0.001	−29.3% (−32.9, −25.5)	<0.001	−26.2% (−33.4, −18.2)	<0.001	−26.4% (−31.2, −21.3)	<0.001	−28.0% (−32.1, −23.7)	<0.001
Teaching Ref: Non-teaching	0.8% (−23.2, 32.4)	0.952	−0.7% (−24.2, 30.2)	0.962	41.1% (−1.0, 100.9)	0.057	0.6% (−21.1, 28.3)	0.962	2.6% (−23.4, 37.5)	0.862
Facility Beds ≥300 Ref: <300 Beds	−49.4% (−62.0, −32.6)	<0.001	−40.2% (−55.0, −20.5)	<0.001	−13.0% (−40.1, 26.5)	0.467	−40.9% (−54.3, −23.6)	<0.001	−52.3% (−64.9, −35.1)	<0.001
U.S. Census Region South Ref: All Other Regions	30.4% (5.1, 61.7)	0.016	33.7% (8.0, 65.6)	0.008	11.9% (−15.8, 48.7)	0.439	13.7% (−6.4, 38.1)	0.196	36.1% (8.0, 71.5)	0.009
Urban Ref: Rural	−21.5% (−39.2, 1.3)	0.063	−18.4% (−36.7, 5.1)	0.115	−15.5% (−39.5, 18.1)	0.323	−18.2% (−34.9, 2.9)	0.087	−22.4% (−41.0, 2.1)	0.070
Time (in Months)	−0.3% (−0.5, −0.1)	0.010	−0.3% (−0.5, −0.1)	0.009	−0.8% (−1.3, −0.4)	<0.0001	−0.1% (−0.4, 0.2)	0.389	−0.4% (−0.6, −0.1)	0.005
Spring Ref: Fall	0.9% (−2.3, 4.2)	0.576	0.9% (−2.2, 4.0)	0.590	−3.3% (−9.2, 3.0)	0.296	1.5% (−2.4, 5.5)	0.462	0.6% (−2.9, 4.1)	0.750
Summer Ref: Fall	1.3% (−1.5, 4.3)	0.361	0.1% (−2.6, 3.0)	0.919	0.1% (−5.4, 5.8)	0.983	2.1% (−1.4, 5.8)	0.250	1.2% (−1.9, 4.4)	0.446
Winter Ref: Fall	−0.6% (−4.0, 2.9)	0.725	2.3% (−1.1, 5.8)	0.188	7.8% (0.8, 15.4)	0.029	4.9% (0.5, 9.4)	0.027	−2.1% (−5.7, 1.7)	0.285
Proportion of Patient Days that are ICU Days	0.0% (−0.7, 0.6)	0.911	−0.3% (−0.9, 0.3)	0.366	3.0% (1.6, 4.4)	<0.001	−3.6% (−4.4, −2.7)	<0.001	−0.4% (−1.1, 0.3)	0.300

Ref: Reference;

^aRates expressed per 1,000 patient days;

^bRates expressed per 1,000 patient hospitalizations;

^cRates expressed per 1,000 ICU patient days;

^dRates expressed per 1,000 non-ICU patient days;

^eBecton Dickinson (BD)

^fShortage defined as cultures from BD BACTEC^™ facilities during the time period of July to November 2024 and non-shortage defined as all other cultures; values with P≤0.050 were bolded

The proportion of adult patients with at least one culture during their hospitalization decreased at BD BACTEC^™ hospitals between the non-shortage and shortage periods (31.3% to 25.7%), (Table 2). The mean number of cultures per adult patient with at least one culture also decreased (2.4 to 1.8) (Table 2). Also, 2.8% of all BD BACTEC^™ cultures were solitary blood cultures during the non-shortage period, and this increased to 7.9% during the shortage period. This increase in solitary cultures occurred among admission, post-admission, ICU, non-ICU, and initial blood cultures (Table 2).

Rate of BSIs and Blood Culture Positivity

The rate of adult hospitalizations with any pathogen positive blood culture decreased from 30.8 to 25.0 per 1,000 hospitalizations at BD BACTEC^™ facilities during the shortage; at non-BD BACTEC^™ facilities, the rate per 1,000 hospitalizations was 19.7 before and 19.0 during the shortage (Table 4). After adjusting for facility characteristics and other factors, there was a 15.3% decrease in the rate of patients positive for a pathogen per adult hospitalizations in affected facilities during the shortage (95% CI: −22.4 to −7.5) (Supplemental Table S7). The median facility change in positive blood cultures per 1,000 hospitalizations between the non-shortage and shortage periods was −15.1% (IQR: −27.9% to −7.3%) at BD BACTEC^™ hospitals and −6.7% (IQR: −14.3% to 5.3%) at non-BD BACTEC^™ hospitals. In addition to an overall decrease in the rate of the detection of BSIs at BD BACTEC^™ facilities, the rates of hospitalizations with blood cultures positive for E. coli, S. aureus, S. pneumoniae, or S. pyogenes per 1,000 hospitalizations all decreased, while at non-BD BACTEC^™ facilities, the decreases were smaller or non-existent for most pathogens (Table 4).

Table 4:

Rate of Bloodstream Infections per 1,000 Hospitalizations Among Adult Patients in Becton Dickinson (BD) BACTEC^™ and non-BD BACTEC^™ Blood Culture Vial Facilities in the Premier Healthcare Database, May 2023 to November 2024

	BD BACTEC™ Blood Culture Vial Facilities (n=11)		Non-BD BACTEC™ Blood Culture Vial Facilities (n=28)
	Non-Shortagea	Shortageb	Non-Shortagea	Shortageb
Rate of Bloodstream Infectionsc	30.8	25.0	19.7	19.0
Staphylococcus aureus d	5.6	4.8	3.9	4.0
Escherichia coli d	8.7	6.6	5.7	5.6
Klebsiella pneumoniae complexd	2.8	2.5	1.8	1.9
Enterococcus faecalis d	1.5	1.6	1.1	1.1
Proteus mirabilis d	1.2	1.2	0.8	0.8
Streptococcus pneumoniae d	1.4	0.6	0.8	0.4
Pseudomonas aeruginosa d	1.2	1.0	0.8	0.8
Streptococcus pyogenes d	1.0	0.5	0.5	0.4

^aNon-Shortage defined as May 2023 to June 2024;

^bShortage defined as July to November 2024;

^cCalculated as patients with blood cultures positive for any pathogen at any time during the hospitalization per 1,000 hospitalizations;

^dRates calculated as patient with a blood culture positive for this organism any time during the hospitalization per 1,000 hospitalizations

At both BD BACTEC^™ and non-BD BACTEC^™ facilities, changes in the proportion of overall cultures positive for a pathogen or common commensal were less than 1% between the non-shortage and shortage periods in most cases (Table 5). At BD BACTEC^™ hospitals, the largest proportional increases during the shortage in percent positivity for a pathogen were among solitary blood cultures (12.4% during the non-shortage to 17.3% during the shortage) (Table 5). The most commonly isolated pathogens and common commensals didn’t change between the non-shortage and shortage time periods (Supplemental Table S8).

Table 5:

Blood Culture Pathogen and Common Commensal Positivity Among Adult Patients in Becton Dickinson (BD) BACTEC^™ and non-BD BACTEC^™ Blood Culture Vial Facilities in the Premier Healthcare Database, May 2023 to November 2024

	BD BACTEC™ Blood Culture Vial Facilities (n=11)		Non-BD BACTEC™ Blood Culture Vial Facilities (n=28)
	Non-Shortagea	Shortageb	Non-Shortagea	Shortageb
Pathogen Blood Culture Positivityc
Overall	7.7%	8.2%	7.8%	7.7%
Admissiond	7.9%	8.3%	7.6%	7.5%
Post-admissione	6.5%	7.6%	9.0%	9.0%
ICU	10.1%	10.7%	10.6%	10.4%
Non-ICU	7.2%	7.6%	7.1%	7.1%
Initialf	7.9%	8.4%	7.4%	7.4%
Solitary	12.4%	17.3%	10.9%	12.3%
Common Commensal Blood Culture Positivityg
Overall	3.7%	3.8%	3.4%	3.2%
Admissiond	4.0%	4.0%	3.5%	3.3%
Post-admissione	2.4%	2.5%	2.6%	2.6%
ICU	4.3%	4.4%	4.3%	4.0%
Non-ICU	3.6%	3.6%	3.1%	3.1%
Initialf	4.3%	4.0%	3.8%	3.7%
Solitary	4.5%	5.4%	3.2%	4.2%

^aNon-Shortage defined as May 2023 to June 2024;

^bShortage defined as July to November 2024;

^cPathogen Positivity: Number of cultures positive for a pathogen per all cultures;

^dAdmission: cultures occurred on or before day 3 of hospitalization;

^ePost-admission: cultures occurred on or after day 4 of hospitalization;

^fInitial: Patient’s first culture during the hospitalization;

^gCommon Commensal Positivity: Number of cultures positive for a common commensal per all cultures

Discussion

Medical product shortages are not uncommon and require a coordinated response to limit patient safety impact. In this national questionnaire of U.S. healthcare facilities, almost one half of respondents indicated using BD BACTEC^™ blood culture bottles. In our multi-center study, we found a 27.4% decrease in blood culture rates at affected hospitals. Some BD BACTEC^™ hospitals were severely impacted while others were not. In affected PHD hospitals, fewer patients had blood cultures, and those with cultures had fewer cultures. Affected hospitals had a 15.3% decrease in the rate of BSIs, which has implications for patient outcomes and surveillance. These findings expand upon the reports of several single-center studies [16–20].

The 15.3% decrease in the rate of patients positive for a pathogen in affected hospitals during the shortage implies cultures may not have been obtained on those with BSIs. This may have negatively impacted patient care. In addition, there are likely to be impacts on the surveillance of infections using blood cultures as part of the case definition. This includes metrics like central line-associated BSIs, hospital-onset bacteremia, and the severe sepsis and septic shock management bundle [21–23]. Lastly, the surveillance of antimicrobial resistant infections, including methicillin-resistant S. aureus or resistant gram-negative bacteria, may have been affected as the rates of both S. aureus and E. coli detection decreased during the shortage [24–27]. Our analysis demonstrated a small increase in the proportion of positive blood cultures (most notable among solitary blood cultures). While some single-center studies have shown increases in percent positivity during the shortage, not all have [17–18, 20]. There were likely competing factors impacting percent positivity during the shortage. Limiting blood cultures in patients with a low pretest probability of bacteremia (e.g., patients with nonsevere cellulitis) may increase percent positivity, while limiting repeat blood cultures in patients with a high pretest probability of a positive culture (e.g., patients with a prior positive blood culture for S. aureus) may decrease percent positivity [3]. This calls into question the utility of using percent positivity as a metric for the diagnostic stewardship of blood cultures, particularly during shortage periods.

Solitary cultures became more common during the shortage. Solitary cultures are typically discouraged as the detection of a pathogen is dependent on blood culture volume, and when only one culture is obtained, it may be difficult to adjudicate whether a culture positive for a common commensal represents a contaminant or pathogen [5–7]. Solitary blood cultures were encouraged by some as a response to the crisis to ensure patients needing blood cultures could obtain one [9, 17, 19, 20]. The increase in solitary cultures in our study was especially dramatic among post-admission cultures. This would be expected if facilities were following the advice of Ryder and colleagues [9]. They suggested single cultures for documenting clearance as an earlier contingency strategy and single blood cultures for initial BSI detection as a later crisis strategy.

A major strength of this study is the use of NHSN to assess the impact of the shortage across a large swath of U.S. healthcare facilities, combined with a more detailed look at utilization in 11 affected PHD hospitals, along with a comparison group of 28 non-affected hospitals. Also, we included a time period that preceded the shortage by a year, allowing us to compare hospitals to themselves. Inclusion of these data allows us to assess whether temporal factors were affecting non-impacted facilities simultaneously as the shortage. Also, our non-shortage culture rates and percent positive proportions were similar to another multicenter study, which was performed prior to the blood culture bottle shortage, increasing our confidence in the validity of our findings [28]. While BD BACTEC^™ and non-BD BACTEC^™ facilities had different culturing rates at baseline and different rates of adult hospitalizations with a blood culture positive for a pathogen, we used modeling to adjust for these differences in facility characteristics.

A limitation of this study, because of the nature of administrative data, is heterogeneity in reporting practices. For example, a facility may report either “coagulase-negative staphylococci” or “Staphylococcus epidermidis”. This makes it difficult to calculate contamination rates as matching cultures may be reported differently, so we did not examine contamination rates in this study [29]. Additionally, typical practice is to collect a set of blood cultures (aerobic and anaerobic bottles). This practice may have been modified during the shortage, but this administrative data does not contain the number of bottles associated with each culture. Also, there is no established standard rate of blood cultures per patient day to optimize patient outcomes, and such a rate would be highly dependent upon many factors including patient acuity. Although the sensitivity of blood culturing practice generally increases with the total amount of blood cultures performed, it does so asymptotically, while the likelihood of detecting a contaminant or clinically unimportant BSI increases. Thus, an important limitation of this evaluation is the lack of studying clinical outcomes to determine optimal blood culturing frequency. Aside from looking at culture rates and positive cultures, we did not examine clinical outcomes such as mortality or antimicrobial usage, limiting our ability to measure patient harm from either under- or over-culturing. Finally, we did not examine whether the characteristics of patients with blood cultures (or positive blood cultures) changed. Future analyses could address which patients were not cultured, the length of antimicrobial therapy of patients who were never cultured, and whether other types of cultures, besides blood cultures, increased during the shortage. Future work could also explore the reasons why blood culture utilization and BSI detection rates were higher in smaller facilities and in the South.

Medical product shortages occur and include devices, antimicrobials, and other medications like intravenous solutions [30–33]. Multi-factorial causes include pandemics, natural disasters, manufacturing problems, or other supply chain disruptions [30]. Similar to our findings, shortages may affect some facilities or patient populations more than others [34]. Collaboration between government, industry, and healthcare systems helps protect patients during shortages. Transparency in supply, distribution, and demand improves the capability to mitigate the impact of the shortage. This study quantifies important changes to patient care during a shortage and demonstrates the value of public health partners’ access to data that can evaluate and mitigate the impact of shortages on patient safety.

Key points:

In the summer of 2024, a nationwide shortage of BD BACTEC^™ blood culture bottles occurred. Our questionnaire found 45.6% of responding facilities used BD BACTEC^™ bottles. Our retrospective cohort study found declines in blood cultures obtained and bloodstream infections detected.