FACT-NetCord International Standards

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FACT-NetCord International Standards
Accreditation

• Foundation for the Accreditation of Cellular
  Therapy
• March 2007
• Phyllis I. Warkentin, MD

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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

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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

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FACT-JACIE International StandardsScope 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

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Accreditation

• FACT JACIE
• Applicant programs 248 90
• Accredited 151 36
• Locations U.S. 13 countries
• Canada
• Australia

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• 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

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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

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QUALITY MANAGEMENT

• Covers all aspects of CB collection, processing,
  testing, banking, selection, release, and
  transport

• QM Supervisor
• Maintain systems to review, revise, approve,
  implement
• all SOPs
• Monitor compliance
• Errors, accidents, biological
• product deviations, adverse events, variances,
  complaints

• Organizational Structure
• Director
• Medical Director
• QM supervisor
• Trained staff

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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

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Operational Standards

• Cover all aspects of CB collection, processing,
  testing, banking, selection, release, and
  transport

• 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

• 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

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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

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FACT-NETCORD Cord Blood Bank AccreditationMarch
2007

• CBB Applicants 54
• US, UK, Europe, Asia
• ACCREDITED 13
• Non-US 9
• Additional inspected 6
• Non-US 3

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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

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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

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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

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FACT/NetCord - Accreditation completed
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Contact Information

• pwarkent_at_unmc.edu
• www.factwebsite.org