Bacterial contamination and septic transfusion reaction rates associated with platelet components before and after introduction of primary culture: experience at a US Academic Medical Center 1991 through 2017

Abstract

BACKGROUND: The high incidence of septic transfusion reactions (STRs) led to testing being mandated by AABB from 2004. This was implemented by primary culture of single-donor apheresis platelets (APs) from 2004 and prestorage pooled platelets (PSPPs) from 2007. STUDY DESIGN/METHODS: Platelet (PLT) aliquotswere cultured at issue and transfusion reactions evaluated at our hospital. Bacterial contamination and STR rates (shown as rates per million transfusions in Results) were evaluated before and after introduction of primary culture by blood centers that used a microbial detection system (BacT/ALERT, bioMerieux) or enhanced bacterial detection system (eBDS, Haemonetics). ABBREVIATIONS: AIPPs = at-issue pooled platelets; APs = apheresis platelets; ARC = American Red Cross; eBDS = enhanced bacterial detection system; FDA = US Food and Drug Administration; NHSNHM = US National Healthcare Safety Network Hemovigilance Module; PCR = polymerase chain reaction; PGD = Pan Genera Detection test; PLTs = platelets; PSPPs = prestorage pooled platelets; STRs = septic transfusion reactions. From the

Fatal sepsis associated with a storage container leak permitting platelet contamination with environmental bacteria after pathogen reduction

“…Prior to the four cases in 2018, only one other case had been reported by the FDA in 2013 involving Acinetobacter species 20 . A platelet unit contaminated with Acinetobacter species that did not result in any transfusion reaction has also been reported 1 …”

“…These environmental conditions are very supportive of bacterial growth. Bacterial contamination has been shown in 1:1000 to 1:3000 platelet components 1–5 . The skin bacterial microflora is the primary source, and less commonly contamination is derived from enteric, oral, and respiratory flora, of which Gram negative organisms in particular can contribute to potentially devastating clinical outcomes.…”

Performance profile of an updated safety measure rapid assay for bacteria in platelets

“…Comparable performance data for other 7-day testing approaches using culture (safety measure on Day 4 or later or large-volume delayed sampling) have either not been generated or published. 12 The updated PGDprime test represents improvement of the original PGD test in ease of use and time to detection of many bacteria, including wild-type strains reported in recent years as PLT contaminants. Rapid testing as a safety measure permits dating extension to 7 days, which has been reported to save more money than it costs in many blood centers and transfusion services.…”

“…It has been proven to detect dangerously contaminated PLTs that are released as falsely negative by early culture methods due to sampling error when the bacterial contamination is still at a very low CFU/mL level. Comparable performance data for other 7‐day testing approaches using culture (safety measure on Day 4 or later or large‐volume delayed sampling) have either not been generated or published 12 . The updated PGD prime test represents improvement of the original PGD test in ease of use and time to detection of many bacteria, including wild‐type strains reported in recent years as PLT contaminants.…”

A Review of Testing Strategies for Bacterial Risk Control in Platelets Recommended by the FDA

“…The test detects bacteria at or below their relevant concentrations in platelets associated with incipient patient sepsis (threshold of toxicity). Jacobs et al [5] and Kundrapu et al [6] published retrospective studies correlating CFU/mL levels of specific bacteria found in platelets and the morbidity observed in transfused patients. Minor toxicity effects were observed at 10 4 CFU/ mL for a few bacteria while the great majority of cases with moderate to severe toxicity were correlated with bacterial loads of 10 5 -10 6 CFU/mL or greater.…”