Format of AABB CT Standards• Cascading pattern:• General quality standards• Technical standards that apply to allcellular therapy products• Technical standards that arespecific to the type of product ordonor• Reference standards (mostdetailed requirements in book)• C or F F = Corresponding record required• Refer to retention time for records (6.2.10)• From Creation or Final Disposition• 5.0: Process Control• 5.7 Verification of Donor Eligibility• F 5.7.2 Donor identity: Requires 2identifiers at procurement• 220.127.116.11 Additional requirements forcord blood: requires identificationof the birth mother beforeprocurement.• Reference standard 5.7.1.A• Contains more detail about donoreligibility requirements
The Standards Program Unit• Content experts•Technical•Scientific•Regulatory• An ethicist (may alsoserve as public rep)• Physicians•Lab Directors•Clinicians• Representative fromAABB accreditationprogram unit• Representativesfrom otherorganizations (AATB,ACOG, ASBMT, ASFA,ASH, FACT, FDA, ISCT,NMDP)AABB Accreditation Program• Based on Standards• Program has policies regarding:• Conflict of interest• Confidentiality• Assessor technical expertise• Organization of accrediting body• Impartiality• Internal and external validation of assessments• CMS (for CLIA- no disparities in >10yrs)• deemed status• Internal validations – min 1% reassessedimmediately after, different team
The Process• Assessment team and duration of assessment based onservices and volume• Team includes AABB staff assessor plus others• Either facility or assessor may decline• Not same assessor for sequential cycles• Unannounced (within an approved date range)• Written policies and procedures• Dispute process (Accreditation Review Cmte)• Assessor CE requirements (content and quantity)• Variance process• Facility can request variance from standards,reviewed by CT SPUAccreditation Spans Entire Process• Collection sites• Testing sites• Processing sites• Storage sites• Infusion sites• Off-site collection facilities (incl UCB)• Physically assess minimum of one site or10% (greater of the two – since 1998)
Selected Changes in AABBCellular Therapy Standards2 nd EditionProcurement Activities• 18.104.22.168: There shall be a process toensure the quality of the procurementactivities when these are performedby a supplier.This is a new standard that clarifiesand strengthens what had alwaysbeen the intent.
Transportation of cryopreserved cellulartherapy components• This section has been significantly modified:C 22.214.171.124 Shipping containers shall be validated andrequalified at defined intervals to ensure they maintaintemperatures within the acceptable range for the duration oftransportation.F 126.96.36.199 When non cryopreserved products aretransported between facilities, the extent of temperaturemonitoring shall be defined.F 188.8.131.52 When cryopreserved products are transportedbetween facilities, the temperature of the shipping containershall be continuously monitored.5.12 – Distribution & TransportationNew Concept• 184.108.40.206 – The receiving facility shall maintainrecords of product acceptability and verifyshipper temperature upon receipt.
Ref Std 5.14B – Processing Tests forHPC, Cord Blood Products• 2) - HLA testing is required• for all products designated for possibleallogeneic use• on a sample from product or donor• at a minimum of HLA-A, -B, -DRB1 loci• using DNA-based technologies• At Confirmatory Testing, HLA-C is alsorequiredAbnormalresultsnotificationReference standard5.7.9A has beencompletely re-doneand is morecomprehensivethan previousreference standardin the 1 st edition.
Changes in the labeling table…• Reference Standard 5.6.2A. Requirementsfor Labeling of Cellular Therapy Products• P=Permanently affixed,• A=Affixed or attached using a tie-tag,tag,• R=accompanying Records• In addition the table is now dividedbetween labeling of the product and theOuter container/Inner Container labelingQuestions…Contact us email@example.com
Harmonization of Cellular TherapyStandards• AHCTA, A formal worldwide group with broadrepresentation has been established.• AHCTA has begun process of comparingstandards/references from at least 7organizations• The Circular of Information- new revision inearly development• The ISBT 128 working group
Cell Therapy HarmonizationTransfusion, 47: July 2007