Institutional authorisation and accreditation of Transfusion Services and Blood Donation Sites: results of a national survey

Blood Transfus. 2011 Oct;9(4):436-54. doi: 10.2450/2011.0025-10. Epub 2011 May 31.


Introduction: The aim of the survey described in this article was to determine decisional and strategic factors useful for redefining minimum structural, technological and organisational requisites for transfusion structures, as well as for the production of guidelines for accreditation of transfusion structures by the National Blood Centre.

Materials and methods: A structured questionnaire containing 65 questions was sent to all Transfusion Services in Italy. The questions covered: management of the quality system, accreditation, conformity with professional standards, structural and technological requisites, as well as potential to supply transfusion medicine-related health care services. All the questionnaires returned underwent statistical analysis.

Results: Replies were received from 64.7% of the Transfusion Services. Thirty-nine percent of these had an ISO 9001 certificate, with marked differences according to geographical location; location-related differences were also present for responses to other questions and were confirmed by multivariate statistical analysis. Over half of the Transfusion Services (53.6%) had blood donation sites run by donor associations. The statistical analysis revealed only one statistically significant difference between these donation sites: those connected to certified Transfusion Services were more likely themselves to have ISO 9001 certification than those connected to services who did not have such certification.

Conclusions: The data collected in this survey are representative of the Italian national transfusion system. A re-definition of the authorisation and accreditation requisites for transfusion activities must take into account European and national legislation when determining these requisites in order to facilitate their effective applicability, promote their efficient fulfilment and enhance the development of homogeneous and transparent quality systems.

MeSH terms

  • Accreditation*
  • Blood Banks / standards*
  • Blood Transfusion / standards*
  • Certification*
  • Humans
  • Italy
  • Surveys and Questionnaires