The operational and financial impact of adding anaerobic screening of platelets

Author:

Rios Jorge1ORCID,Webb Jonathan2,Dy Beth2,Young Pampee P.23ORCID

Affiliation:

1. American Red Cross Biomedical Dedham Massachusetts USA

2. American Red Cross Biomedical, Product and Process Management Washington District of Columbia USA

3. Vanderbilt University Medical Center, Department of Pathology Microbiology, and Immunology Nashville Tennessee USA

Abstract

AbstractBackground and ObjectivesWe evaluated the operational and safety impact of implementing anaerobic culture screening of apheresis and pooled platelets at the American Red Cross on the already established use of the aerobic culture screening of each donation performed no sooner than 24 h following collection.Materials and MethodsPlatelets were screened for bacterial contamination with the BACT/ALERT 3D® (bioMérieux, Durham, NC) microbial detection testing system. The addition of anaerobic culture to the already existing aerobic culture resulted in sampling an additional 8–10 mL from each donation.ResultsImplementation of anaerobic testing resulted in an approximate 3.5‐fold increased rate of False Positive BACT/ALERT alarms. There was a modest increase in the rate of True Positive alarms of 1.4‐fold with increased detection of Klebsiella and Propionibacterium species, including Cutibacterium acnes. In addition, there was an approximate 3.5‐fold increase rate of False Positives and a 13.5‐fold increase rate of Indeterminates, the majority (~57%) were due to Cutibacterium acnes. The combined costs and lost revenue associated with adding anaerobic screening increased by ~$1,000,000/year due to testing cost and product discards.ConclusionThe addition of anaerobic culture to aerobic culture to the original donation (without the introduction of sampling delay) resulted in a significant increase in the rate of alerts. The 40% increased rate of True Positive alarms may have modestly improved platelet safety. However, there was a disproportionate increase in the rate of False Positive and Indeterminate bacterial culture alarms, which added substantial cost and overall loss of platelet products.

Funder

American Red Cross

Publisher

Wiley

Subject

Hematology,Immunology,Immunology and Allergy

Reference19 articles.

1. Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion. US FDA. Available from:https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bacterial-risk-control-strategies-blood-collection-establishments-and-transfusion-services-enhance.

2. A Comparison of Transfusion-Related Adverse Reactions Among Apheresis Platelets, Whole Blood-Derived Platelets, and Platelets Subjected to Pathogen Reduction Technology as Reported to the National Healthcare Safety Network Hemovigilance Module

3. AABB.Association bulletin #0407 actions following an initial positive test for possible bacterial contamination of a platelet unit. Available from:https://www.aabb/org/news-resources/resources/association-bulletins. AABB2004.

4. Bacterial culture of apheresis platelets: a mathematical model of the residual rate of contamination based on unconfirmed positive results

5. Fatal Sepsis Associated with Bacterial Contamination of Platelets — Utah and California, August 2017

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