Ann Lab Med.  2023 Sep;43(5):477-484. 10.3343/alm.2023.43.5.477.

Reducing Microbial Contamination in Hematopoietic Stem Cell Products and Quality Improvement Strategy: Retrospective Analysis of 1996-2021 Data

• Ko YK
• Lee JK
• Park HK
• Han AK
• Mun SK
• Park HJ
• Choung HK
• Kim SM
• Choi KM
• Lee NY
• Cho D
• Kim DW
• Kang ES

• KMID: 2551996
• DOI: http://doi.org/10.3343/alm.2023.43.5.477

Abstract

Background
Sterility and safety assurance of hematopoietic stem cell (HSC) products is critical in transplantation. Microbial contamination can lead to product disposal and increases the risk of unsuccessful clinical outcomes. Therefore, it is important to implement and maintain good practice guidelines and regulations for the HSC collection and processing unit in each hospital. We aimed to share our experiences and suggest strategies to improve the quality assurance of HSC processing.
Methods
We retrospectively analyzed microbial culture results of 11,743 HSC products processed over a 25-year period (January 1996 to May 2021). Because of reorganization of the HSC management system in 2008, the 25-year period was divided into periods 1 (January 1996 to December 2007) and 2 (January 2008 to May 2021). We reviewed all culture results of the HSC products and stored aliquot samples and collected culture results for peripheral blood and catheter samples.
Results
Of the 11,743 products in total, 35 (0.3%) were contaminated by microorganisms, including 19 (0.5%) of 3,861 products during period 1 and 16 (0.2%) of 7,882 products during period 2. Penicillium was the most commonly identified microorganism (15.8%) during period 1 and coagulase-negative Staphylococcus was the most commonly identified (31.3%) during period 2. HSC product contamination occurred most often during HSC collection and processing.
Conclusions
The contamination rate decreased significantly during period 2, when the HSC management system was reorganized. Our results imply that handling HSC products by trained personnel and adopting established protocols, including quality assurance programs, aid in decreasing the contamination risk.

Keyword

Hematopoietic stem cells; Microbial contamination; Microbial culture; Bacteremia; Catheter-associated contamination; Quality assurance

Figure

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  Fig. 1 Annual numbers of hematopoietic stem cell products collected and the proportion of culture-positive products between January 1996 and May 2021.

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