The procedures for authorisation and accreditation of Transfusion Structures and blood donation centres: what are the requisites? The experience of the Transfusion Service and AVIS blood donation centres in Ravenna.

BACKGROUND: The system of accreditation of Italian transfusion structures (Transfusion Services and blood donation centres, these latter being managed by voluntary associations) guarantees the National Health Service that the service provided to citizens, patients and donors who use these structures, is correctly authorised, meets further, additional requisites relative to the quality of health care, and that these are documented and controlled during a formal audit. MATERIALS AND METHODS: We present here the experience gained, in the period 2007-2009, by the Transfusion Service of the local health authority of Ravenna and of the AVIS blood donation centres in the Province of Ravenna (Italy). These blood donation centres are managed in the context of a stipulated arrangement in which agreement was reached concerning not only the purposes, but also the quality requirements of the blood product collection, the operative methods, and the indicators and surveillance of non-conformities, in order to monitor and improve the blood supply system in the province. RESULTS: Our data show that, over time, there was a improvement in the distribution of collection of whole blood across the days of the week and better training of staff, as demonstrated by a reduction in non-conformities. Analysis of the data encouraged the identification of a new organisation with computerisation of the blood donation centres and their progressive merging. CONCLUSIONS: There are numerous, precise legislative and technical indications to guarantee the quality of performances in transfusion medicine, from the collection of blood to its allocation. These indications constitute a qualified basis for the development of accreditation models whose final validation is the duty of specifically designated regional and national institutions. The procedure for obtaining accreditation, planned and carried out uniformly by the Transfusion Service and the voluntary association's donation centres was an occasion for professional staff to improve the quality of the services delivered. Collectively, these aspects have increased transparency and improved the system of blood supply in the province of Ravenna.

Adverse reactions to blood donations: the READ project.

BACKGROUND: 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. MATERIALS AND METHODS: 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). RESULTS: 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. CONCLUSIONS: 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.