AABB Cord Blood Standards and Accreditation Programs Karen Shoos Lipton, JD, Chief Executive Officer

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AABBCord Blood Standards and Accreditation
ProgramsKaren Shoos Lipton, JD, Chief Executive
OfficerAugust 18, 2004
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Overview

• About the AABB
• AABBs Cord Blood Program
• AABB Cord Blood Standards
• AABB Cord Blood Accreditation Process

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AABBs Vision

• AABB will be the preeminent knowledge-based
  organization focused on improving health through
  the advancement of science and the practice of
  transfusion medicine and related biological
  therapies, developing and delivering programs and
  services to optimize patient and donor care and
  safety

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AABB Cord Blood Program

• HPC and cord blood standards and accreditation
• Educational programs
• Cooperative efforts with other organizations,
  e.g., ISCT, NMDP, FACT, ASBMT
• Focus on collection laboratory processes and
  the cord blood product

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AABB Cellular Therapies Working Group

• Kathleen Sazama, MD, JD, UT MD Anderson Cancer
  Center
• Edward Snyder, MD, Yale-New Haven Hospital
• Elizabeth Read, MD, National Institutes of Health
• John McMannis, PhD, UT MD Anderson Cancer Center
• D. Michael Strong, PhD, Puget Sound Blood Center

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AABB Standards

• 1958 Standards for Blood Banks and Transfusion
  Services
• 1991 Standards for Blood Banks and Transfusion
  Services included HPC requirements
• 1996 Standards for Hematopoietic Progenitor Cell
  and Cellular Product Services
• 2001 Standards for Cord Blood Services
• 2004 Standards for Cellular Therapy Services

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AABB Cord Blood Standards

• Integrate quality management and technical
  requirements
• Allow for continuous improvement in emerging
  field

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Cord Blood Standards (contd)

• Revised every two years, with use of interim
  standards, as needed
• Committee of experts and a public representative

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Cord Blood Standards (contd)

• Standards only include requirements
• AABB experience in developing standards in FDA
  regulated climate

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Scope of Cord Blood Standards

• Donor selection and eligibility
• Procurement, processing and storage
• Interface between issuing facility and
  administering facility
• Engraftment outcomes data
• NOT regulating practice of medicine

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Outcomes Data

• AABB standard 17.3 requires review of information
  re administration and transplant outcomes,
  including
• Adverse reactions related to infusion
• Engraftment
• Survival
• Occurrence of graft-vs-host disease

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HPC and Cord BloodFuture Format

• In 2004, AABB will publish a comprehensive
  Standards for all cellular therapies, including
  HPCs, cord blood, pancreatic islets, and other
  somatic cells
• Streamline all aspects of cellular processing
  with an eye towards compliance with GTPs
• Content remains compatible with ISO

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AABB Accreditation Program

• Compliance with Standards
• Educational Aspect
• 2-year process

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AABB Accreditation ProgramCord Blood Activities
Assessment Tool
Accreditation requirements (1st edition Cord
Blood Standards) 9.5.2.4 Review of Processing
Record After completion of processing the cord
blood service director shall review the
processing record of each cord blood unit in a
timely manner.

• Sample Assessment Questions
• (Sample questions are intended as a guide. None
  are required. Questions used need not be asked
  directly. Responses may be obtained by other
  means such as observation or record review.)
• Who reviews the processing record of each cord
  blood unit?
• How is the review indicated n the processing
  record?

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Cord Assessors

• AABB Staff lead assessor
• Team assessors (Subject matter experts)
• 5 years working experience in HPC and Cord
  activities
• Evaluate facility operational areas
• All assessors undergo training and continuing
  education

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What Does AABB Accreditation Cover?

• Collection
• Testing
• Processing
• Storage
• Distribution
• Outcomes of Administration and Transplantation

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Preparing for an Assessment

• Review of current standards, procedures and
  previous nonconformances by facility
• Submission of pre-assessment materials by
  facility
• Review of materials by assessors prior to site
  visit to understand facility processes

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Assessment

• Interview staff
• Sample records
• Verify implementation of processes and procedures
• Corroborate information through observation
• Review objective evidence obtained during
  assessment

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Nonconformance

• Must be linked to a requirement in the Standards
• Based upon objective evidence, not assessor
  opinion
• Evaluate conformance to the intent of the
  requirement

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Nonconformance (contd)

• A policy/process/procedure not defined or
  documented
• Requires the facility to submit a written plan of
  corrective action

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Corrective Action Plan

• Due date for action plan is 30 days from
  assessment date
• Corrective action plan must include
• Root cause analysis to identify possible system
  failure
• Planned, scheduled events to resolve failures

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Summary Session

• Meeting with key facility representatives
• Assessment objective restated (to verify
  conformance to the requirements)
• Facility accomplishments acknowledged
• If any nonconformance exists, requirement
  restated and NC described
• Facilitys understanding of the issue(s) being
  presented verified
• Assessor leaves copy of summary report at facility

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Reassessments

• Reassessment triggered if
• Major failures to meet requirements
• Major management or organizational change
• Merger with another company
• Complaint received

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Final Steps

• Facility response reviewed by two technical
  specialists in the AABB office both must deem it
  acceptable
• Educational support offered/provided
• Additional information requested as necessary
• Upon approval, accreditation documents sent to
  facility
• Re-assessed every 2 years

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Conclusion

• AABB strives to provide donors and recipients
  with the best possible care.
• We invite a representative(s) of the committee to
  participate in an AABB assessment.