Abstract Background and Objectives Growth of gram‐negative bacteria in a platelet concentrate (PC) is inevitably accompanied by the accumulation of endotoxin, which is the major component of the outer cell membrane of these organisms. However, less is known about the kinetics of endotoxin accumulation in PC and its biological activity. Therefore, the endotoxin level of Klebsiella pneumoniae contaminated PCs was measured over time. In addition, the biological activity of the contaminants was analysed by an assay that mimics the human fever response in vitro. Materials and Methods The bacterial endotoxin test and the monocyte activation test were established for PC samples for endotoxin and pyrogen detection, respectively. Low‐count spiking of PCs using K. pneumoniae PEI‐B‐P‐08 was performed by six laboratories, and samples were taken over time. The samples were analysed for the number of viable cells, the amount of endotoxin and their capacity to induce the production of fever‐inducing cytokine interleukin 6 (IL‐6). Results K. pneumoniae showed fast proliferation in contaminated PCs reaching stationary phase 36 h post‐spiking. Endotoxin was measurable in samples with a bacterial load of more than 10 3 CFU/mL and increased proportionally to the number of bacteria present. IL‐6 production was found to be linked to endotoxin levels in PCs reaching levels of high pyrogenicity 24 h post‐spiking. Conclusion PCs contaminated with more than 10 3 CFU/mL of K. pneumoniae might be a risk for patients due to their ability to induce pyrogenic reactions during transfusion.
Abstract Background and Objectives South African hospitals face a high anaemia burden, variable access to patient blood management (PBM) modalities and uneven adoption of evidence‐informed transfusion practice. Pragmatic, context‐appropriate tools are needed to standardise practice and support implementation. Materials and Methods We conducted semi‐structured interviews with PBM champions ( n = 16, across six provinces in South Africa) to generate candidate toolkit items, then validated these via a three‐round e‐Delphi with a panel of 11 subject experts. Items were rated on a 3‐point Likert scale (1 = Essential; 2 = Useful; 3 = Unnecessary). Consensus was defined as ≥80% of the panel selecting the same option. Stability was defined as ≤20% (two or fewer) panellists who changed their response by Round 3. Results Round 1 included 793 statements; consensus was reached on 49.1% of items. Round 2 presented 400 non‐consensus statements remaining after Round 1, and an additional set reached consensus, raising the cumulative total to 72.5%. Round 3 included 214 statements; by the end of Round 3, cumulative consensus was 88.1%. A further 10.8% of items met the predefined stability criterion without reaching consensus. Only eight items were unresolved. Conclusion This mixed‐methods process yielded a context‐aware PBM toolkit framework for South Africa. It prioritises pre‐operative anaemia optimisation, restrictive transfusion practice, standardised peri‐operative haemorrhage protocols, fit‐for‐purpose education and practical monitoring and accountability tools with clear ownership.
Abstract Background and Objectives National blood systems require a resilient mechanism for ensuring safe blood supply during pandemics. For small island developing states (SIDS) additional specific challenges exist not normally addressed in guidelines and the literature. Here we describe the model used by the Caribbean island of Curaçao for pandemic preparedness during the COVID‐19 pandemic. Materials and Methods Key measures taken by the Red Cross Blood bank Foundation Curaçao during the COVID‐19 pandemic were examined. National blood program data were analyzed retrospectively. Results For pandemic preparedness, critical main processes were adapted during the COVID‐19 pandemic. These included individual donor time‐scheduled phlebotomy sessions and government‐authorized lockdown travel permits. Work procedures focusing on the prevention of simultaneous presence of personnel during shifts were introduced. Donor information was provided during governmental public health briefings. Patient blood management programs were adopted according to international recommendations in consultation with the blood bank. During the COVID‐19 pandemic, characterized by four severe outbreaks over 2 years, donor availability and donations were maintained with sufficient labile blood product supply to all hospitals served. Conclusion For SIDS, effective small‐scale implementation of international recommendations on pandemics remains challenging. The national blood program preparedness model of Curaçao proved to be successful during the COVID‐19 pandemic, ensuring uninterrupted donor participation and sufficient labile blood product availability. Key success factors of the model were a voluntary, non‐remunerated, repetitive donor program, a central blood collection facility, acknowledgement of the blood bank as important in the public health pandemic response, and effective communication with donors, hospitals, and health authorities.
Abstract Background and Objectives Parvovirus B19 (B19V) testing is often not required to release blood components. However, the European Pharmacopoeia requires that plasma pools for fractionation contain no more than 10 4 IU/mL of B19V DNA. In France, pool B19 nucleic acid testing (NAT) screening was performed by Établissement Français du Sang since 2015. Since June 2024, positive pools are broken down into individual testing, allowing for the identification and management of infected blood donations. Materials and Methods B19V NAT is performed in pools of 96 donations (P96) with the DPX Parvo/hepatitis A virus assay (Roche). A P96 with a viral load >10 4 IU/mL B19V DNA is considered positive. All individual donations (IDs) testing reactive for B19V by ID‐NAT are excluded from plasma‐based medicinal products production, and the corresponding blood components are destroyed if not yet transfused. Results From June 2024 to June 2025, 99 of 2,627,678 donations (3.7/100,000) were B19V DNA positive. All blood components related to 90 donations were discarded. Of the remaining nine donations, 13 blood components (9 platelet concentrates [PCs] that had undergone pathogen reduction (PR) and four red blood cell [RBC] concentrates) were transfused before NAT results were obtained. Two B19V transmissions were reported in recipients (0.078/100,000 transfusions) after transfusion of 1 PR‐PC and 1 RBC unit. Conclusion B19V DNA testing for plasma intended for fractionation performed in blood services helps in avoiding transmissions by the related blood components, provided positive donations are detected prior to their transfusion. Delayed availability of results may result in transfusion‐transmitted B19V infection, which cannot prevented by current PR technology.
