AABB Standards andAccreditation Program:

International Components

Karen Shoos Lipton, JDCEO

AABB FDA CT Liaison Meeting January 4, 2007

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AABB Mission

To advance the practice and standards of transfusion medicine and related biological therapies

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AABB Profile

n Established in 1947n Institutional membersn Individual membersn International organizationnStandards and Accreditation

Programs since 1957

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HCT/P Accreditations

n AABB has accredited 147 HPC and UCB facilitiesn17 are outside US nAdditionally, 11 in early stages of

accreditation application (all international)

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AABB Standards Programn Well defined infrastructuren Process includes experts in field, ethicists,

public, FDA and other organizationsn Established timelines for updates n Allows for interim and emergent standardsn Requires member and public comment

periodn Standards developed in FDA regulated

climate

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Standardsn Incorporate Quality Management

System and Technical Requirementsn Internationally accepted

n Compatible with ISO

n Cellular Therapy Standards also compatible with GTPs (effective May 25, 2005)

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AABB Accreditation Programn Well established program - 50 yrs.n Designed to operate in a regulated

climaten Policies guide programn Operates under internationally accepted

standards for accrediting bodiesn Accreditation based on assessment of

conformance to standards

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International Accreditation

n Process is the same for all facilitiesn International variancesn Applies to US specific details which

other countries cannot meet (usually testing)

n NOT routinely granted

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Language Variationsn Accreditation manual requires all plans,

policies and procedures to be in English

n When possible, assessor who speaks that language is sent

n Lead assessor on all HPC and UCB assessmentsn Accompanies volunteer with content

expertisen Provides Consistency

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Accreditation Program Policy Manual

n Well-defined infrastructuren Policies consistent with

internationally accepted standards for accrediting bodies, ISO Guide 58

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ISO Guide 58n Addresses issues:

n Requires the accrediting body to operate under a quality management system

n Resolves conflict of interest issuesn Ensures impartialityn Requires technical expertisen Addresses organization of accrediting bodyn Addresses confidentiality of information

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Validation of Accreditation Programn External: CMS performs validation

surveys based on volumen Approved by CMS as equivalent to, or more stringent

than, the CLIA conditionn AABB has not had any disparities in >10 years

n Internal: Random selection of 1% of assessmentsn New: continuous improvementn Different team sent outn Thus far, consistent with original findings

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Assessments: Systems Approach

n Reviews objective evidencen Demonstrates operations over a

period of time, not a point in timen Beginning Jan 2007 – unannounced

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Imported Products

n AABB standards apply:nSupplier qualification and product

acceptance specificationsnAgreements (includes scope of

service; responsibilities of each)nVendor qualificationnReceipt and shipping criteria

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AABB Requirements: Supplier Qualificationn Must evaluate supplier

n Must establish and maintain policies, processes and procedures to ensure materials and services conform to requirementsn FDA Guidance, Sept 2006 “Compliance with 21 CFRR Part

1271.150(c)(1)-Manufacturing Arrangements

n Define type of control and qualifications; risk based on potential impact on product quality

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New Standard: Procurement Activitiesn There shall be a process to ensure the

quality of the procurement activities when these are performed by a supplier n Further clarifies the intent that all

agreement and supplier requirements apply to collection/procurement/import of products and other materials

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AABB Requirements: Agreementsn Must have policies, processes and

procedures for developing, approving and reviewing agreements

n Before acceptance – review agreementn Confirm scope of servicen Can meet requirementsn Addresses medical services

• Requires medical order for procurement, processing and storage

• Obtain and share data for outcomes and adverse events

n Define process for changes

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AABB Requirements: Agreements for Collectionn Procedures for receipt, handling

and administrationn Reporting adverse eventsn Access to records (both infusion

and registry)n Informed consentn Physician order

n Procurementn Processing and storagen Administration

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AABB Requirements: Informed Consentn Rights as research subject (if applicable)n Explanation of procedure and risksn Sample procurement, testing and

storagen Infectious disease testing and

notification of positive resultsn Review of medical history and recordsn Discussion of confidentiality and product

ownership (including loss or damage)n Additional requirements for UCB donors

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AABB Requirements: Upon Receipt of Material/Productn Inspected and/or tested as appropriate

n FDA approved/cleared test kits

n Qualification of facilities providing test or services:n Lab certified by CMS and registered with FDA if indicated by 21 CFR

610.40(f).

n System to notify shipper and manufacturer of unacceptable condition(s)

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During assessmentn AABB accredits activities, not facilitiesn Assessor looks for documentation of:

n Sample agreementn Documentation of agreement reviewn Vendor qualification (ex certificates, SOP

review, audits)n Donor eligibility determinationn Ongoing monitoring and reportingn Deviation management of incoming

materials/products

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Summaryn AABB Standards comply with FDA GTPs and

apply to imported productsn EU struggling with similar issues

n “Agreements between tissue establishments and third parties….must comply with Directive…specify terms…protocols to be followed to meet required specification”

n “Must be a documented system for ratifying that tissues and/or cells meet appropriate specifications”

n Alliance for Harmonization of Cellular Therapy Accreditation (AHCTA)n Beginning with Import/export requirements