Lu Wen, Delaney Meghan, Dunbar Nancy M, Rossmann Susan N, Fung Mark
Robert Tomsich Pathology & Laboratory Medicine Institute, Cleveland Clinic, Cleveland, Ohio, USA.
Pathology and Laboratory Medicine, Children's National Hospital, Washington, DC, USA.
Transfusion. 2020 Aug;60(8):1681-1687. doi: 10.1111/trf.15851. Epub 2020 Jun 21.
Bacterial contamination of platelets is the leading infectious risk to the United States (US) blood supply. On 30 September 2019, the US Food and Drug Administration (FDA) published a Final Guidance for Industry to reduce the risk of transfusing platelets contaminated by bacteria. A national survey was undertaken to assess readiness, attitudes, and the potential impact on hospital-based transfusion services.
A survey was distributed to transfusion services in all 50 US states. Summary statistics were performed along with review and categorization of email feedback and free text comments.
Eighty-three transfusion services from 48 states participated in this survey study. Currently, the most common approach is primary culture performed at manufacturing (n = 49/83, 59%). Of the bacterial risk mitigation strategies provided by the FDA, the most frequently preferred are (a) pathogen reduced platelets (PRP) for up to 5-day storage (n = 36/77, 47%), (b) large volume delayed sampling (LVDS) ≥48 hours for up to 7-day storage (n = 16/77, 21%), and (c) primary culture ≥24 hours + secondary rapid testing for up to 7-day storage (n = 7/77, 9%). The main motivating factors for the survey participants' selected strategies to comply with FDA final guidance were product availability from supplier, reducing the risk of septic transfusion reactions (STR), and complexity of implementing and performing a new or additional test.
While having platelets to transfuse and preventing STR are of the utmost importance, nationwide, the majority of transfusion services do not want to take on performing new or additional testing in their laboratories.
血小板的细菌污染是美国血液供应面临的主要感染风险。2019年9月30日，美国食品药品监督管理局（FDA）发布了一项行业最终指南，以降低输注受细菌污染血小板的风险。开展了一项全国性调查，以评估准备情况、态度以及对医院输血服务的潜在影响。
向美国所有50个州的输血服务机构发放了调查问卷。进行了汇总统计，并对电子邮件反馈和自由文本评论进行了审查和分类。
来自48个州的83个输血服务机构参与了这项调查研究。目前，最常见的方法是在生产时进行初次培养（n = 49/83，59%）。在FDA提供的降低细菌风险策略中，最常被青睐的是：（a）储存期长达5天的病原体灭活血小板（PRP）（n = 36/77，47%）；（b）储存期长达7天、≥48小时的大容量延迟采样（LVDS）（n = 16/77，21%）；以及（c）储存期长达7天、初次培养≥24小时+二次快速检测（n = 7/77，9%）。调查参与者选择符合FDA最终指南策略的主要推动因素是供应商提供的产品可用性、降低败血症输血反应（STR）的风险以及实施和执行新的或额外检测的复杂性。
虽然有血小板可供输注和预防STR至关重要，但在全国范围内，大多数输血服务机构不想在其实验室进行新的或额外的检测。
