Post on 23-Dec-2015
FACT-NetCord International Standards &
Accreditation
Foundation for the Accreditation of Cellular Therapy
March 2007Phyllis I. Warkentin, MD
NetCord-FACT Standards
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
Foundation for the Accreditation of Cellular Therapy - FACT
• 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
• JACIE – Joint Accreditation Committee of EBMT / ISCT
• Joint International Standards for Cellular Therapy Products
FACT-JACIE International 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
Accreditation
FACT JACIEApplicant programs 248 90
Accredited 151 36
Locations U.S. 13 countriesCanadaAustralia
• 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
etCordetCord
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
QUALITY MANAGEMENT Covers all aspects of CB collection,
processing, testing, banking, selection, release, and transport
Organizational StructureDirectorMedical DirectorQM supervisorTrained staff
QM Supervisor: Maintain systems to review,revise, approve, implement all SOPs Monitor compliance Errors, accidents, biological
product deviations, adverse events, variances, complaints
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 non- conforming units Maintenance of appropriate,
safe and secure facilities Detailed records Documented agreements
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 requirementsMaternal 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
FACT-NetCord Accreditation• Voluntary accreditation
• Educational, collegial, helpful inspections• Accommodates family units / banks and URD banks
• 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
FACT-NETCORD Cord Blood Bank
AccreditationMarch 2007
CBB Applicants 54US, UK, Europe, Asia
ACCREDITED 13Non-US 9
Additional inspected 6Non-US 3
FACT-NetCord StandardsInternational Acceptance
• Thirteen CBB accredited - US, UK, Europe
• 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
FACT-NetCord Standards International Acceptance
• Australia• Therapeutic Goods Administration, Office of Devices,
Blood and Tissues, regulates CB under Australian code of GMP and NetCord-FACT Standards
• WMDA – voluntary organization to establish international guidelines for collection and transfer of hematopoietic stem cells
• Adopted NetCord-FACT Standards for CBB• Deemed status for accreditation
• AsiaCord• Adopted NetCord-FACT Standards
FACT/NetCord Accredited Cord Blood Banks
• Banc de Cordó de Barcelona Barcelona, Spain• Besançon Cord Blood Bank of the Etablissement Français du Sang Besançon, France• BMDI Cord Blood Bank Melbourne, Victoria, Australia
• Carolinas Cord Blood Bank Durham, North Carolina, USA
• The Finnish Cord Blood Bank Helsinki, Finland
• José Carreras Cord Blood Bank Düsseldorf, Germany
• Liege Cord Blood Bank Liege, Belgium
• London Cord Blood Bank Edgware, Middlesex, United Kingdom
• MD Anderson Cord Blood Bank Houston, Texas, USA
• Milano Cord Blood Bank Milano, Italy
• National Cord Blood Program New York, New York, USA• Pavia Cord Blood Bank Pavia, Italy
• StemCyte, Inc. Arcadia, California, USA
FACT/NetCord - Accreditation completed
Contact Information
pwarkent@unmc.edu
www.factwebsite.org