SIMT Azienda Ospedaliera Ragusa, Italy.
Blood Transfus. 2010 Jan;8(1):49-62. doi: 10.2450/2009.0089-09.
In 2006 in Italy 2,404,267 donations of blood components were made by 1,539,454 donors; approximately 55% of the donations were collected directly by Transfusion Structures (TS), while about 45% were collected in Donation Centres managed by Associations and Federations of Donors. The aim of the READ (Rilevamento Eventi Avversi alla Donazione) project is to create a network of TS to test a standardised system for monitoring adverse events (AE) related to blood donations.
Shared, standardised data collection forms, compatible with the forms produced by the ISBT-EHN, were prepared. Two types of form were used: (i) a form to collect data on single events (READ 1), to be used at the individual collection sites; (ii) a form for processing the data collected by each TS (READ 2).
Between February and August 2008 six TS collected data related to the donation of 89,332 units of blood. Overall, 523 AE were recorded. The AE occurred in 0.59% of the donations. The mean duration of the symptoms was 17 minutes. Fifteen percent of the symptoms were related to the venipuncture (mainly haematomas) and 77% to vasovagal AE. The AE were defined severe (grade C) in 47 cases. The donations in which AE were recorded were completed in 81% of the cases; 59% of the AE did not require treatment. Three donors were monitored briefly (for less than 4 hours) in hospital.
The use of standardised forms enabled the collection of data that could be analysed. Some problems related to the performance of the haemovigilance programme did, however, emerge: (i) organisational problems, (ii) limited sensitivity, (iii) inadequate training, and (iv) poorly defined responsibilities. These problems must be resolved at various levels: local, regional and national.
2006 年，意大利共有 1539454 名献血者进行了 2404267 次血液成分捐献；其中约 55%的捐献是由输血机构（TS）直接采集的，而约 45%是在由献血者协会和联合会管理的献血中心采集的。READ（献血不良反应监测）项目的目的是建立一个 TS 网络，以测试一种用于监测与献血相关的不良事件（AE）的标准化系统。
准备了共享的、标准化的数据收集表格，与 ISBT-EHN 生成的表格兼容。使用了两种类型的表格：（i）用于收集单个事件数据的表格（READ 1），用于在各个采集点使用；（ii）用于处理每个 TS 收集的数据的表格（READ 2）。
2008 年 2 月至 8 月期间，6 个 TS 收集了与 89332 单位血液捐献相关的数据。总体而言，记录了 523 例 AE。AE 的发生率为 0.59%。症状的平均持续时间为 17 分钟。15%的症状与静脉穿刺（主要是血肿）有关，77%与血管迷走性 AE 有关。AE 被定义为严重（C 级）的有 47 例。记录 AE 的捐献中有 81%完成；59%的 AE 不需要治疗。有 3 名献血者在医院接受了短暂（不到 4 小时）的监测。
使用标准化表格能够收集可分析的数据。然而，血液监测计划的执行也出现了一些问题：（i）组织问题，（ii）敏感性有限，（iii）培训不足，以及（iv）责任界定不明确。这些问题必须在各个层面上解决：地方、区域和国家。
