Vox Sanguinis (2013) 105, 174–176 SHORT REPORT © 2013 International Society of Blood Transfusion DOI: 10.1111/vox.12026 Haematopoietic stem cell transplantation: a comparison between the accreditation process performed by competent authorities and JACIE in Italy L. Lombardini, 1 A. Bosi, 2 S. Grosz, 3 D. Pamphilon, 4 D. Fehily, 1 M. Mareri, 1 C. Carella, 1 M. Pia Mariani, 1 S. Pupella, 5 G. Grazzini 5 & A. N. Costa 1 Italian National Transplant Centre, Istituto Superiore di Sanit a, Rome, Italy 2 University of Florence, Florence, Italy and GITMO, Genova, Italy 3 University of Applied Sciences Bioengineering, FH Campus Wien, Austria 4 Jacie Executive Committee, Barcelona, Spain 5 Italian National Blood Centre, Istituto Superiore di Sanit a, Rome, Italy Received: 6 April 2012, revised 12 December 2012, accepted 14 December 2012, published online 9 February 2013 There have been great advances over the last decades in haematopoietic stem cell (HSC) transplantation, using either bone marrow, peripheral blood or cord blood- derived stem cells. The coming into force of the European legislation on tissues and cells and the consequent transposition of Directives into national laws have required the health authorities in the Member States (MS) and the scientific soci- eties to review the transplantation activities to ensure the circulation of safe HSC products. Here, the regulatory inspection process performed by the Competent Authorities and the professional voluntary accreditation process of the Transplant Programmes active in Italy is compared. Key words: haematopoietic stem cell, transplantation, quality management Introduction The Italian legal framework regulating HSC derives from transfusion [1] and transplant [2, 3] laws. Those regarding quality and safety are transposed by European Directives 2004/23/EC[4], 2006/17/EC [5] and 2006/86/EC [6]. The globally accepted technical standards are those defined by the Joint Accreditation Committee of ISCT (Interna- tional Society for Cell Therapy) (JACIE) and European group for Blood and Marrow Transplantation (EBMT) [7] that foresee professional accreditation. The common goal of these Directives [4–6] and the JACIE standards [7] is to ensure that tissue establishments (TEs) and transplant pro- grammes (TPs) meet standard safety and quality criteria, and work in compliance with good manufacturing, labo- ratory and clinical practice. According to Directive 2004/ 23/EC [4], the Competent Authorities (CAs) must regularly assess TEs compliance with requirements of technical Directives [5, 6], through inspections. JACIE also performs periodical audits in the TPs following JACIE standards. According to mandatory requirements of the above cited Directives, implemented by Legislative Decrees 191/ 2007 [2] and 16/2010 [3], the Italian National Transplant Centre (CNT) and the National Blood Centre (CNS) have started an inspection programme to licence of TEs that collect, process, store and distribute HSC. These inspec- tions are performed together with a JACIE team. The inspectors must be health professionals with proven expe- rience of minimum 2 years in HSC sector; JACIE requires that auditors be qualified professionals (nurses, biologists, technicians, physicians) working in HCS transplantation. Both CAs and JACIE provide initial training for candidate inspectors and CAs also a retraining and periodical assessment of inspectors’ competence. Between 2005 and 2009 the European CAs and JACIE performed inspections in 14 HSC centres in Italy, Nether- lands and United Kingdom, comparing the non-complianc- es observed by the two teams (data not yet published). The non-compliances detected in 7/14 TPs, performed accord- ing to the joint audit model adopted in Italy, were reviewed. One hundred and fifty-two non-compliances recorded by Correspondence: Letizia Lombardini, Italian National Transplant Centre, Istituto Superiore di Sanità, via Giano della Bella 34, 00161 Rome, Italy. E-mail: centronazionale.trapianti@iss.it 174