Implementation of a proficiency testing programme for bacterial screening in platelet preparations in Canada

Mastronardi, Cherie; Martincic, Irene; Ramírez‐Arcos, Sandra

doi:10.1111/j.1423-0410.2007.00948.x

Cited by 3 publications

(4 citation statements)

References 15 publications

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“…Published contamination rates varies between 1:5,000 and 1:20,000 [10,11]. Meanwhile different risk reduction measures have been recommended and implemented [12][13][14].…”

mentioning

confidence: 99%

Transfusion-Transmitted Bacterial Infections – Haemovigilance Data of German Blood Establishments (1997–2010)

Funk¹,

Lohmann²,

Guenay³

et al. 2011

Transfus Med Hemother

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Methods: In order to evaluate the benefit of risk minimisation measures, reporting rates of transfusion-transmitted bacterial infections (TTBI) were calculated on the basis of annual reports and distributed blood components. Following the implementation of risk minimisation measures in 2003 and 2008, a comparison of pre- and post-implementation periods was performed. Results: During a period of 14 years, 90 cases of TTBI were confirmed, 34 were caused by red blood cell (RBC) concentrates, 5 by fresh frozen plasma, and 51 by platelet concentrates (PCs). The overall reporting frequency was 1 TTBI in 1.91 million RBC units; 1 TTBI in 0.094 million PC units, and 1 TTBI-associated fatality in 0.57 million PC units. From 2001–2004 the reporting rate was 13.7 per million PC units; 2005–2008, after the implementation of pre-donation sampling; it was 10.8 per million PC units (p > 0.5). After limitation of the shelf life (2008), the reporting rate decreased to 4.49 per million PC units (p = 0.12), and one case of related fatality was reported. Agents with low pathogenicity were reported in 14 of 41 immunosuppressed patients (34%) but only in 1 of 13 patients with non-haematological/oncological diseases. Conclusion: TTBI and associated fatalities could be gradually reduced by the risk minimisation measures, but further strategies such as implementation of sensitive screening tests or pathogen-reducing approaches should be discussed.

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“…Published contamination rates varies between 1:5,000 and 1:20,000 [10,11]. Meanwhile different risk reduction measures have been recommended and implemented [12][13][14].…”

mentioning

confidence: 99%

Transfusion-Transmitted Bacterial Infections – Haemovigilance Data of German Blood Establishments (1997–2010)

Funk¹,

Lohmann²,

Guenay³

et al. 2011

Transfus Med Hemother

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“…The detection of P. aeruginosa and P. putida , if capable of growing in PCs at all, did not benefit from a reduced incubation temperature; in fact, the opposite was true. Similarly, a study by Mastronardi et al, which developed a proficiency testing programme for cultural screening methods, showed acceptable growth kinetics for P. aeruginosa using the standard temperature of the BacT/Alert automated culture system [ 23 ].…”

Section: Discussionmentioning

confidence: 99%

Dual-Temperature Microbiological Control of Cellular Products: A Potential Impact for Bacterial Screening of Platelet Concentrates?

Vollmer,

Knabbe,

Dreier

2023

Microorganisms

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An experimental study by the Paul-Ehrlich Institute (PEI) demonstrated that temperatures between 35 and 37 °C are too high for the growth of some bacterial strains (e.g., Pseudomonas fluorescens), leading to false negative results. Thus, the question of whether it is necessary to adapt incubation temperatures for the microbiological control of blood products, especially platelet concentrates (PCs), to enhance safety and regulatory compliance has arisen. In order to further elucidate this issue, the growth capability of different bacterial strains of interest in PCs and the detection efficacy of cultivation of these at different incubation temperatures must be taken into account. Therefore, we inoculated PCs with 46 different strains (3–6 PCs from different donors per strain) from different origins (PC isolates, reference strains) and stored PCs at 20–22 °C under constant agitation. On day three of storage, the inoculated PCs were sampled; aerobic and anaerobic culture bottles (BacT/Alert AST/NST) were each inoculated with 5 mL of sample, and culture bottles were incubated at 25 and 35 °C using the automated BacT/Alert Dual-temperature system. Bacterial proliferation was enumerated using a colony-forming assay. All strains of Enterobacteriacae (n = 5), Staphy-lococcus spp. (n = 11), Streptococcus spp. (n = 5), and Bacillus spp. (n = 4) and most Pseudomonas aeruginosa strains (4 of 5) tested showed the capability to grow in most inoculated PCs, revealing a faster time to detection (TTD) at an incubation temperature of 35 °C. The tested Pseudomonas putida (n = 3) strains showed a noticeably reduced capability to grow in PCs. Nonetheless, those with a notable growth capability revealed a faster TTD at an incubation temperature of 35 °C. Only one of the four Pseudomonas fluorescens strains tested (strain ATCC 13525) was able to grow in PCs, showing a faster TTD at an incubation temperature of 25 °C but also detection at 35 °C. The commonly detected bacteria involved in the bacterial contamination of PCs showed a superior TTD at 35 °C incubation. Only one P. fluorescens strain showed superior growth at 25 °C; however, the microbiological control at 35 °C did not fail to identify this contamination. In conclusion, the use of PC screening using a dual-temperature setting for microbiological control is presently not justified according to the observed kinetics.

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“…CAP regulatory standards for blood culture detection methods). Already published proficiency programmes focusing on bacterial contamination of PCs so far include the application of culture methods or pH measurement . Commercially available CAP proficiency testing panels dealing with bacterial detection in platelets contained two different sample materials: (a) lyophilized pelleted specimen which can be reconstituted and used for bacterial culture and detection systems and (b) frozen sample material for use with the PGD assay .…”

Section: Discussionmentioning

confidence: 99%

“…The objective assessment of the performance of such methods is an important quality criterion to evaluate the analytical method. Currently published proficiency programmes were aimed at qualitative bacterial detection using culture methods or pH measurement . The rationale of the proficiency panel developed in this study was focused on the verification of the test performance especially of a wide range of rapid and point‐of‐care detection methods at their limit of detection.…”

Section: Introductionmentioning

confidence: 99%

Establishment of a proficiency panel for an external quality assessment programme for the detection of bacterial contamination in platelet concentrates using rapid and cultural detection methods

et al. 2016

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Implementation of a proficiency testing programme for bacterial screening in platelet preparations in Canada

Abstract: Canadian Blood Services has successfully implemented a proficiency testing programme for bacterial screening in platelet preparations, which will contribute to improving the safety of the platelet supply in Canada.

Cited by 3 publications

References 15 publications

Transfusion-Transmitted Bacterial Infections – Haemovigilance Data of German Blood Establishments (1997–2010)

Transfusion-Transmitted Bacterial Infections – Haemovigilance Data of German Blood Establishments (1997–2010)

Dual-Temperature Microbiological Control of Cellular Products: A Potential Impact for Bacterial Screening of Platelet Concentrates?

Establishment of a proficiency panel for an external quality assessment programme for the detection of bacterial contamination in platelet concentrates using rapid and cultural detection methods

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