Quality Improvement After Multiple Fatal Transfusion-Transmitted Bacterial Infections

Jessica Corean, MD; Rami Al-Tigar; Theodore Pysher, MD; Robert Blaylock, MD; Ryan A. Metcalf, MD

Disclosures

Am J Clin Pathol. 2018;149(4):293-299. 

In This Article

Abstract and Introduction

Abstract

Objectives Transfusion-transmitted bacterial infection (TTBI) from platelet components is likely underrecognized and can be fatal. Twenty-four-hour prospective culture was felt to be insufficiently preventive after multiple TTBIs occurred and strategies to improve safety were sought.

Methods Two fatal and one severe TTBIs occurred from a split-apheresis platelet donation contaminated with Klebsiella pneumoniae. Improvement opportunities were identified and corrective and preventive action (CAPA) followed.

Results To mitigate bacterial contamination and improve detection sensitivity, additional prospective culture 48 hours postcollection was implemented. Since implementation, secondary cultures have caught two true positives (0.01%) missed by 24-hour culture. Bacterial testing at issue and pathogen reduction were later implemented as an added layer of safety.

Conclusion While rare, TTBI is a prominent cause of morbidity and mortality from contaminated platelets. The approach to CAPA presented here may lower the risk of future transfusion-transmitted infections but must be weighed against potential added costs.

Introduction

It is well documented that platelet components are the most common source of septic transfusion reactions given their room temperature storage conditions. Rates of contamination have been estimated from 1 in 1,000 to 10,000 units, usually from donor skin flora or occult bloodstream infection.[1–3] Transfusion-transmitted bacterial infections (TTBIs) are likely underrecognized clinically, but fatalities continue to be reported to the US Food and Drug Administration (FDA) each year.[4] In the United States, between 2011 and 2015, microbial-contaminated transfusion fatalities were the fourth most common cause of death, accounting for 10% of the total transfusion-related fatalities.[5] Most fatal bacterially contaminated platelet units were due to Gram-negative bacteria, and one reported fatality from 2011 to 2015 was due to Klebsiella pneumoniae.[5] While stringent requirements for bacterial detection of platelet products have been in place for many years, they are insufficient to prevent all potential TTBIs. Because apheresis platelet collections can yield multiple co-components, hemovigilance with timely reporting of suspected transfusion reactions can be critical for expeditious quarantining of any co-components remaining in inventory. To maximally prevent adverse outcomes from TTBI, a more comprehensive strategy may be undertaken. An approach to improve the sensitivity of bacterial detection is discussed here along with eventual implementation of testing at issue and pathogen reduction technology.

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