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					NetCord-FACT


   International Cord Blood Bank
    Standards and Accreditation

                      Phyllis I. Warkentin, MD
                      April 28, 2008

                The Foundation for the Accreditation of Cellular Therapy
Foundation for the Accreditation of Cellular Therapy

 Co-founded in 1996 by:
  • American Society for Blood and Marrow Transplant
  • International Society For Cellular Therapy

 Purposes:
  • Establish standards for quality medical and laboratory
    practice
  • Implement voluntary inspection & accreditation program




                             The Foundation for the Accreditation of Cellular Therapy
FACT: Major Goals
   To promote quality patient care and quality
    laboratory performance
     – a valid accreditation process for HPC transplant must
       include assessment of clinical practice, cell collection,
       and laboratory services

   To protect research and development
    environment in this rapidly evolving field where
    major therapeutic advances are being made




                               The Foundation for the Accreditation of Cellular Therapy
FACT Standards
   First edition published 1996
          – Clinical Guidelines of ASBMT
          – Laboratory Standards of ISCT
   Covers all phases of collection, processing, and administration
    of hematopoietic progenitor or therapeutic cells
   Clinical Program must utilize a collection service and a cell
    processing laboratory that meet FACT Standards:
          – FACT - accredited or successfully inspected
     No specific program structure is required
     Functional coordination and cooperation required
     Maintain comprehensive Quality Management Program
     Follow and analyze patient outcomes


                                      The Foundation for the Accreditation of Cellular Therapy
FACT Accreditation - April 2008

 First accredited HPC programs in
        North America             March 1998
   •   HPC Facilities registered                  195 (~92%)
   •   Accredited Programs                        159
        (US and Canada)
   •   HPC Renewal Accreditation:
              Programs               142
              Inspection visits      226


                           The Foundation for the Accreditation of Cellular Therapy
Joint Accreditation Committee ISCT & EBMT
                              Countries participating:
 Established 1999                Austria                      Norway
 Adopted FACT standards          Belgium                      Poland
  1999                            Czech Republic               Slovakia
 FACT supported inspector        Denmark                      Slovenia
                                  Estonia                      Spain
  training in 2000, 2001,
  2002                            Finland                      Sweden
                                  France                       Switzerland
 Joint review of 2002 FACT       Germany                      Turkey
  standards
                                  Greece                       United
 Joint international FACT-       Hungary                         Kingdom
  JACIE standards 2006            Italy
                                  The Netherlands
                              The Foundation for the Accreditation of Cellular Therapy
Cord Blood Bank Standards and Accreditation




 1996: FACT Standards for Hematopoietic Progenitor Cells,
         first edition published
 2000: International Standards for Cord Blood Banking
 2002: International Inspection and Accreditation Program
         in cord blood banking started
 2006: Third Edition of Cord Blood Standards published


                           The Foundation for the Accreditation of Cellular Therapy
The International NetCord Foundation

A Foundation of member cord blood banks
established to globally unite supply and demand
of umbilical cord blood and to construct and
maintain world-wide standards and a system of
quality approval in the area of umbilical cord
blood



                      The Foundation for the Accreditation of Cellular Therapy
              NETCORD Inventory and Use March 2008
                                       Released for
CB Bank                     Inv entory  Transplant                Children                Adults
                               NETCORD/FACT a ccre dite d
Sydne y + Me lbourne              15066                   437                    224                  213
Ba rce lona                        8487                   387                    172                  207
Düsse ldorf                       13353                   484                    247                  217
Duke                              11340                   780
Fra nce Cord                       6310                   782                    255                  527
He lsinki                          2856                    17                      9                    8
Houston                            4031                    54                     26                   28
Lie ge                             1935                   106                     45                   61
London                             8612                   174                    105                   69
Mila n                             6712                   346                    159                  187
Ne w York                         31331                  2584                   1654                  930
Pa via                             2033                    74                     30                   44
Sum                           112066                   6225                 2926                2491
                              not NETCORD/FACT a ccre dite d
Athe ns                              560                      5                    4                    1
Brisba ne                           3341                     30                   14                   16
Fire nze                            1020                     54                   26                   18
Ga uting                            2257                     35                   17                   18
Le ide n                            3505                     63                   27                   36
Le uve n                            8104                   111                    61                   50
Louva in                            1866                     80                   30                   50
ULB-Borde t                         1298                     26                    9                   17
Má la ga                           10057                     79                   26                   53
Ma nnhe im                          1642                     29                   17                   12
Me x ico - CNTS                     1029                     72                   48                   24
Pa dova                             1267                     41                   17                   24
Pe sca ra                            375                      3                    2                    0
Pra gue                             2899                     22                   10                   12
Roma La zio                         1187                     45                   24                   21
Sa ntia go de Composte la           4983                     41                   18                   23
Se oul                              4599                      8                    0                    8
Te l Ha shome r                     1385                     12                    3                    9
Tokyo                               5218                   755                   204                  551
Sum                            56592                   1511                  557                 943
T OT AL                       168658                   7736                 3483                3434
                                                          H. Gressmann, NETCORD Virtual Office, Duesseldorf
Worldwide Distribution of Transplant Centers
 (NETCORD VIRTUAL OFFICE - March 2008)




                        142
      82
                                   35
                    1
                              13

           46

                                        8
NetCord-FACT Standards
Major Goals
 Promote quality practices in maternal and donor
   screening, and cord blood collection, processing,
   testing, banking, transport, selection, and release
        • Describe minimal guidelines for each process
 Promote availability of quality cord blood units for
  transplantation
 Protect research, development, new products


                          The Foundation for the Accreditation of Cellular Therapy
FACT-NetCord
Cord Blood Bank Accreditation April 2008

        CBB Applicants                           55
            US, UK, Europe, Asia,
            Australia, South Africa

        ACCREDITED                               15
           Non-US                      10
        Additional inspected                       4
            Non-US                       2




                           The Foundation for the Accreditation of Cellular Therapy
Standards Development




              The Foundation for the Accreditation of Cellular Therapy
NetCord-FACT
Standards Setting Process
STANDARDS COMMITTEE
 Standards Chairperson:
    Third Ed – Linda Kelley, PhD / Fourth Ed – Nancy Collins, PhD
 CBB Standards SubCommittee Chairperson:
    Third Ed – EJ Shpall, MD / Fourth Ed – Joanne Kurtzberg, MD

 Membership:
    FACT Cellular Therapy Standards Committee
         (ASBMT, ISCT, JACIE)
      NetCord and NetCord Banks
      Other non-NetCord Bank CBB experts
      Content experts – infectious disease screening / testing
      Others – governmental liaisons


                                  The Foundation for the Accreditation of Cellular Therapy
NetCord-FACT
Standards Setting Process
First Edition, 2000
     Review and merge existing documents:
         FACT HPC Standards
         NetCord operating policies and procedures
Standards Process
    New/revised standards drafted by Standards Committees
    Standards developed by consensus
    Review: Oversight Committee / Legal review
    Published for member / public comment
    Comments reviewed; Standards revised
    Adopted by Boards of Directors - FACT, NetCord
    Effective 90 days after publication
    Accredited programs expected to be in compliance

                                 The Foundation for the Accreditation of Cellular Therapy
NetCord-FACT
Interim Standards
 Proposed by Standards Committee, Board member or
  any participant
 Indicated to address urgent situations
    Newly emergent diseases
    New process developments
 Standards Committee review
 Approval and adoption:
      • FACT Board of Directors
      • NewCord Board of Directors
 Publish and distribute for immediate implementation


                          The Foundation for the Accreditation of Cellular Therapy
NetCord-FACT Standards: Scope
  Comprehensive Standards cover all phases of cord
  blood donor screening / testing; CB unit collection,
  processing, testing, banking, transport, selection, and
  release
 Require all cord blood banks to:
     Maintain a comprehensive Quality Management Program
     Utilize validated / qualified methods, supplies, reagents, and
      equipment
     Maintain details of clinical outcome



                                The Foundation for the Accreditation of Cellular Therapy
 FACT-NetCord
 Accreditation Process

Accreditation is based upon
documented compliance
with NetCord-FACT
International Standards for
Cord Blood Banks, current
edition




                          The Foundation for the Accreditation of Cellular Therapy
FACT Inspection /Accreditation
  Voluntary accreditation
       • Educational, collegial, helpful inspections
       • Accredited programs published – newsletters, website
  Basis for accreditation: NetCord-FACT Standards
       • Written application and on-site inspection
       • Central office preview and review
  Volunteer inspectors, experts in the field; peers
  Accreditation Committee reviews each report;
   determines next steps and accreditation status;
  Results & appeals to Boards of Directors



                            The Foundation for the Accreditation of Cellular Therapy
Inspector Qualifications
  Member of ISCT, ASBMT, EBMT, Euro-ISCT, or NetCord
  FACT or FACT-NetCord accredited or applicant facility
  Relevant education and experience
     MD/PhD, RN/MT, biological science degree
        • >1 year CBB supervisor or director/medical director; or
        • Active FACT/JACIE Clinical inspector (with training)
     MD/PhD, MT, biological science degree
        • > 2 years supervisor or Director of CBB or HPC Laboratory
  Completed inspector training course
     Written exam covers Standards and Process
  Satisfactory completion of trainee inspection
  Satisfactory evaluations by applicants and team members


                                   The Foundation for the Accreditation of Cellular Therapy
CBB Inspector Training Courses
   June 2000       San Diego, CA USA
   Nov. 2000       New York, NY USA
       Mock inspection – National Cord Blood Bank, NY Blood Center
   May 2002     Barcelona, Spain
     May 2004 Dublin, Ireland
     June 2005 Los Angeles, CA USA
     May 2006 Berlin, Germany
     May 2006 Los Angeles, CA USA
     May 2007 Los Angeles, CA USA
     March 2008 Florence, Italy

                                The Foundation for the Accreditation of Cellular Therapy
FACT Inspection / Accreditation
                                 Checklist documentation
                                    Promote consistency and completeness
    APPLICANT     INSPECTOR
                                    Address process and specific detail
    Y   N   N/A   Y   N   N/A
                                    Focus on Standards
D                                Checklist design
                                    Questions directly from each Standard
D
                                    Some redundancy
D
                                          Flexibility in CBB structure / inspector
D                                          assignments
                                          Cross-checking among inspectors
                                 Checklist structure
                                     Facility answers each item – application
                                     Inspectors verify – report
                                 Methodology consistent with the addition of
                                  supplemental forms if needed for additional
                                  requirements
                                              The Foundation for the Accreditation of Cellular Therapy
Accreditation Process
 Demographic application
 Complete / submit checklist, required documents, English
  documents
 FACT accreditation coordinator reviews, assists applicant in
  improvements and completion
 On-site inspection scheduled
    Dates chosen by applicant; appropriate personnel available (2 days)
    Team: sufficient size and expertise to assess applicant
        Includes at least Team Leader, Collection inspector, Lab inspector
        Potential conflicts:
            Geographic / Direct economic competition prohibitions
            Conflict of Interest and Confidentiality Agreements
            Inspectors instructed to recuse themselves if perceived conflict
            CBB Director approves team; can refuse specific inspectors
 Visit all sites; proportion of collection sites over 5
 Observations made, discussions with CBB personnel

                                    The Foundation for the Accreditation of Cellular Therapy
Collection Sites
 CBB Collection Sites - Criteria
    Sites with various activity levels
    Include intermediate storage facilities
    Include all types of collectors
          CBB staff / Hospital staff / Physicians, midwives
    Observe all collection methods
          In utero / ex utero
    Observe all modes of supply provision
          CBB-provided / Collection site provided / “Kits”
    Observe all modes of CBB unit transport
          Volunteer courier / employee / contract courier / mail
    Include collection sites in other cities from “bank”
 CBB Director schedules collection site visits


                                        The Foundation for the Accreditation of Cellular Therapy
CBB Collection Site Algorithm

          Collection                Minimum no.
            sites                    inspected
            1–5                         ALL
           6 – 15                        5
           16 - 25                       6
            >25                          7*
        * As needed to fulfill criteria



                               The Foundation for the Accreditation of Cellular Therapy
Accreditation Process
 Exit Interview summarizes major findings
    No final accreditation decisions are made on-site
 Inspection Team members complete / submit reports
 Evaluations of each other, trainees, and process to FACT Office
 Team report reviewed by FACT accreditation coordinator
    Circulate draft to team members before submission
 CB Accreditation Committee review; determines interim
  action; informs Boards of FACT / NetCord
 Boards retain ultimate responsibility for Accreditation
  Committee composition and outcomes
 Corrections to citations to document compliance made by
  applicant; on-going process rather than one time pass/fail


                               The Foundation for the Accreditation of Cellular Therapy
FACT-NetCord Inspection Outcomes

 Practice not in compliance with any Standard = DEFICIENCY
 Every deficiency must be corrected prior to accreditation
       • Longer term corrections – planned corrections accepted;
         implementation of correction documented at annual report
       • Alternative practices / variances are not accepted
 This is the only way it is possible to be clear about the
  meaning of accreditation
       • If the issue is important enough to warrant a specific Standard,
         it is important enough to not allow variable alternatives




                                  The Foundation for the Accreditation of Cellular Therapy
Outcome Data in Accreditation Decision
   CBB are not accredited if specific outcome data are not
    obtained / used by the CBB for process improvement.
        Required data points – engraftment, infusional toxicity, GVHD,
         chimerism, long term patient follow up
        Quality and quantity of outcome data are part of the final
         inspection report as evaluated by the Accreditation Committee
   Process outcomes are evaluated by sophisticated inspectors
    and accreditation not awarded if problems are identified:
        High rate of bacterial contamination
        Adverse trends in laboratory practice
        High or trending high rate of bag breakage or product thaw during
         transport or shipping
         Low or discrepant TNC after thawing at transplant center
        Serious adverse event – mislabeled product release


                                    The Foundation for the Accreditation of Cellular Therapy
FACT-NetCord Inspections
Potential Outcomes
            No deficiencies
                 Full accreditation - 3 years
            Few and scattered deficiencies
                 Written response
                 Chairman and staff evaluate responses
                  ± review by CBB Accreditation Committee
                 Accreditation
            Major and Systemic deficiencies
                 Written response
                 Focused reinspection of specific areas
                  OR reinspection of entire program
                 Accreditation Committee review
            Non-accreditation
                 Reapplication

                   The Foundation for the Accreditation of Cellular Therapy
 FACT-NetCord Accredited CBB
 Annual Report
 Annual report form required from each accredited
  Cord Blood Bank
 Documentation of significant change
 Verification of personnel, collection sites
 Update collection, inventory, and distribution data
 Clinical outcome data
 Documentation that processes have been
  implemented to correct previously cited deficiencies

                          The Foundation for the Accreditation of Cellular Therapy
Renewal Accreditation

             Accreditation is for 3 years
             Reaccreditation must be completed
              prior to expiration of the current
              accreditation
             Process is similar to initial
             Edition of Standards current on the
              day of inspection is the edition
              used for the renewal inspection



                  The Foundation for the Accreditation of Cellular Therapy
Communication and Cooperation
 NetCord – NMDP Collaboration Agreement
      Merged data base and unified search agreement
 NMDP pays for FACT-NetCord accreditation of
  participating Cord Blood Banks
 FACT Professional Relations Committee
 FACT supports representation on other organizations
  Standards Committees
 Active participation in Circular of Information Task
  Force, Uniform Donor History for Cellular Products
  Task Force


                              The Foundation for the Accreditation of Cellular Therapy
FACT/NetCord – Accredited Cord Blood Banks April 2008
 • Banc de Cordó de Barcelona                             Barcelona, Spain
 • Besançon Cord Blood Bank of the Etablissement
      Français du Sang                            Besançon, France
 • BMDI Cord Blood Bank                 Parkville, 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
 • LifeCord                                Gainesville, Florida, USA
 • 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
 • Sydney Cord Blood Bank Randwick, New South Wales, Australia

                                  The Foundation for the Accreditation of Cellular Therapy
Communication

     www.factwebsite.org

      pwarkent@unmc.edu
       lmiller1@unmc.edu



              The Foundation for the Accreditation of Cellular Therapy

				
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