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