Haematopoietic stem cell transplantation: A comparison between the accreditation process performed by competent authorities and JACIE in Italy

Vox Sanguinis

Volumn 105, Issue 2, 2013, Pages 174-176

  Lombardini, L ^a   Bosi, A ^b,c   Grosz, S ^d   Pamphilon, D ^e   Fehily, D ^a   Mareri, M ^a   Carella, C ^a   Pia Mariani, M ^a   Pupella, S ^a   Grazzini, G ^a   Costa, A N ^f  

^a ISTITUTO SUPERIORE DI SANITÀ   (Italy)

^b UNIVERSITY OF FLORENCE   (Italy)

^c GITMO   (Italy)

^d Fachhochschule Campus Wien   (Austria)

^e Jacie Executive Committee   (Spain)

^f NONE

Author keywords

Haematopoietic stem cell; Quality management; Transplantation

Indexed keywords

ACCREDITATION; ARTICLE; AUTHORITY; COMPARATIVE STUDY; HEALTH PROGRAM; HEMATOPOIETIC STEM CELL TRANSPLANTATION; ITALY; PERIPHERAL BLOOD STEM CELL TRANSPLANTATION; PRIORITY JOURNAL; REGULATORY MECHANISM; RISK ASSESSMENT; UMBILICAL CORD BLOOD;

HAEMATOPOIETIC STEM CELL; QUALITY MANAGEMENT; TRANSPLANTATION;

FEMALE; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMANS; ITALY; MALE; MEDICAL AUDIT; QUALITY OF HEALTH CARE;

EID: 84880322318     PISSN: 00429007     EISSN: 14230410     Source Type: Journal    
DOI: 10.1111/vox.12026     Document Type: Article

References (12)

1. Law of 21 October 2005 n. 219 "New discipline of transfusion activities and production National blood products". Official Journal of the Italian Republic, GU n. 251 of 27 October 2005
2. Legislative Decree of 6 November 2007, n. 191 "Implementation of Directive 2004/23/EC definition of standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of tissues and cells human". Official Journal of the Italian Republic, GU n. 261 of 9 November 2007- Suppl. n.228
3. Legislative Decree of 25 January 2010, n. 16 "Implementation of Directives 2006/17/CE and 2006/86/CE, implementing the directive 2004/23/CE regarding technical requirements for donation, procurement and the surveillance of human tissues and cells, and regarding the dispositions on traceability, the notification of serious reactions and events and some technical dispositions for the coding, processing, preservation, storage and distribution of human tissues and cells". Official Journal of the Italian Republic, G.U. n. 40 of 18 February 2010
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7. JACIE Standard 4th edition, October 2008
8. Fehily D, Kurz H, Hornez T, et al.: "The development of EUSTITE guidelines for the inspection of tissue and cell procurement and tissue establishments in the European Union". Organs Tissues & Cells 2008; 11:167-174
9. Arrêté du 3 avril 2009 relatif au contenu du document d'évaluation des activités de greffes d'organes et de greffes de cellules hématopoïétiques.21 abril 2009 - Edition numéro 0093, Journal Officiel de la Republique Francaise
10. German Standards for Unrelated Blood Stem Cell Donations. http://www.zkrd.de/en/_pdf/ZKRD-Standards-V8_english.pdf
11. Regeling Haemopoietische Stamceltransplantatie. The Netherlands 25 October 2006. http://www.st-ab.nl/wettennr05/0636-08_Regeling_haemopoietische_stamceltransplantatie.htm
12. Guidance of the Federal Office for Social Insurance. http://www.bag.admin.ch/kv/gesetze/d/KLV.Mod.1.1.2005.de%2029.11.04.pdf.