Le norme internazionali NetCord-FACT: linee guida per la qualità nel bancaggio del sangue cordonale

Transcription

1 Le norme internazionali NetCord-FACT: linee guida per la qualità nel bancaggio del sangue cordonale

2 Topics 1- NetCord-FACT: l organizzazione internazionale ed il suo scopo 2- Le norme di qualità sul bancaggio del sangue cordonale. Breve riassunto e contenuti significativi

3 Fourth Edition, January 2010 Goals To promote quality practices: maternal and donor selection, screening, and testing cord blood collection, process, testing, banking, selection, release, and transport. To consistently assure provision of quality CB units To permit research and development

4 Co-founded in 1996 by: American Society for Blood and Marrow Transplant International Society For Cellular Therapy Purposes: Establish and promote standards for quality medical and laboratory practice in hematopoietic progenitor cell transplantation and other cellular therapies Implement voluntary inspection & accreditation program

5 FACT STANDARDS: SCOPE AND CONTENT Standards apply to: Hematopoietic progenitor cells from any tissue source Therapeutic cells (nucleated cells other than HPC) Cover all phases of collection, processing, administration (excluding collection and banking of cord blood cells) Require all clinical, collection and laboratory facilities to: Develop and maintain a comprehensive Quality Management Plan Evaluate and report outcomes Comply with Applicable Law

6 1996: FACT Standards for Hematopoietic Progenitor Cells 2000: International Standards for Cord Blood Banking 2002: International Inspection and Accreditation Program started 2006: Third Edition of Standards published 2010: Fourth Edition of Standards published

7 NETCORD-FACT STANDARDS: SCOPE AND CONTENT Cover all phases of cord blood collection, processing, testing, banking, selection, release Require all cord blood banks to: Maintain comprehensive Quality Management Program Utilize validated methods, supplies, reagents, equipment Maintain product tracking Maintain details of clinical outcome Comply with Applicable Law CBB must have a process to address every Standard

8 QUALITY MANAGEMENT Covers all aspects of CB collection, processing, testing, banking, selection, release, and transport Organizational Structure Director Medical Director QM supervisor Trained staff QM Supervisor: Maintains systems to review, revise, approve, implement all SOPs Monitor compliance Errors, accidents, biological product deviations, adverse events, variances, complaints

9 QUALITY MANAGEMENT Covers all aspects of CB collection, processing, testing, banking, selection, release, and transport Written process controls to ensure CB units: Conform to specification Are correctly identified unique identifier Are not contaminated or cross-contaminated Maintain function / integrity Management of nonconforming units Maintenance of appropriate, safe and secure facilities Detailed records Documented agreements

10 OPERATIONAL STANDARDS Cover all aspects of CB collection, processing, testing, banking, selection, release, and transport Donor selection, screening, testing, eligibility determination SOPs Validation of processes, equipment, supplies, reagents Detailed labeling requirements Maternal samples, units, reference samples, documents Bar-coding ISBT 128 Specific assays for purity, potency: infectious disease testing (mom) HLA class I and II TNC, CD34+ number CFU (unrelated) microbial testing hemoglobinopathy Unanticipated events: Inventory transfer, cessation

11 FACT-NETCORD ACCREDITATION Voluntary accreditation On-site inspection and written materials Must address each standard. No partial accreditation Volunteer inspectors, highly experienced in the field, peers affiliated with accredited or applicant program Rigorous, two days, observe collections / processing Visit all sites (proportion of collection sites) Team report reviewed by FACT technical staff CB Accreditation Committee review; recommend action to Boards of NETCORD and FACT Improvements to achieve compliance required

12 FACT-NETCORD ACCREDITATION 2010 CBB Applicants 60 US, UK, Europe, Asia ACCREDITED 25 Non-US 15

13 FACT-NETCORD STANDARDS INTERNATIONAL ACCEPTANCE 25 CBB accredited (2010)- US, UK, Europe, Australia Italy NETCORD-FACT Standards translated into Italian 2002 Published by Istituto Superiore di Sanità for clinical guidance Accepted as a recommendation by the Italian Ministry of Health

14 FACT/NetCord Accredited Cord Blood Banks Banc de Sang i Teixits Barcelona, Spain Besançon Cord Blood Bank of the Etablissement Français du Sang Besançon, France Sydney Cord Blood Bank Sydney, Australia Carolinas Cord Blood Bank Durham, North Carolina, USA The Finnish Cord Blood Bank Helsinki, Finland José Carreras Cord Blood Bank Düsseldorf, Germany Liège Cord Blood Bank Liege, Belgium NHS Cord Blood Bank Edgware, Middlesex, United Kingdom MD Anderson Cord Blood Bank Houston, Texas, USA Milano Cord Blood Bank Milano, Italy Pavia Cord Blood Bank Pavia, Italy National Cord Blood Program New York, New York, USA StemCyte, Inc. Arcadia, California, USA

15 FACT/NETCORD - ACCREDITATION COMPLETED

16 Grazie per la vostra attenzione!