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QREs: A Subset of Biological Product Deviation Reports

QREs: A Subset of Biological Product Deviation Reports. Sharon O’Callaghan CBER Office of Compliance and Biologics Quality Division of Inspections and Surveillance. Public Workshop: Quarantine Release Errors September 13, 2011. Agenda. Overview of BPD Reports BPDs identified as QREs

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QREs: A Subset of Biological Product Deviation Reports

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  1. QREs: A Subset of Biological Product Deviation Reports Sharon O’Callaghan CBER Office of Compliance and Biologics Quality Division of Inspections and Surveillance Public Workshop: Quarantine Release Errors September 13, 2011

  2. Agenda • Overview of BPD Reports • BPDs identified as QREs • Contributing Factors Sharon O'Callaghan

  3. Biological Product Deviation (BPD) Data • BPD Reports received between Oct. 1, 2005 and Sept. 30, 2010 (FY06-FY10) • Type of Establishments • Licensed Blood Establishment • Unlicensed Registered Blood Establishments • Transfusion Services Sharon O'Callaghan

  4. BPD Reports Received FY06-FY10All Blood Establishments Sharon O'Callaghan

  5. Quarantine Release Errors (QREs) • Information known PRIOR to distribution of product that warrants quarantine; product subsequently distributed • BPDs not included: • Post Donation Information • Labeling • Routine Testing (ABO, Rh, antibody, antigen) • Miscellaneous – seroconversions, possible transfusion transmitted disease Sharon O'Callaghan

  6. BPD Reports Received FY06-FY10All Blood Establishments Sharon O'Callaghan

  7. BPD Reports Received FY06-FY10Licensed Blood Establishments Total BPDRs (133,164) includes Labeling, Miscellaneous, Post Donation and Routine Testing - not shown Sharon O'Callaghan

  8. BPD Reports Received FY06-FY10Unlicensed Registered Blood Establishments Total BPDRs (19,431) includes Labeling, Miscellaneous, Post Donation and Routine Testing - not shown Sharon O'Callaghan

  9. BPD Reports Received FY06-FY10Transfusion Services Total BPDRs (8,857) includes Labeling and Routine Testing - not shown Sharon O'Callaghan

  10. Blood Collection BC41** Sterility compromised Air contamination; Arm prep not performed or performed inappropriately BC42** Collection bag Blood drawn into outdated bag; Incorrect collection bag used BC43** Collection process Collection time extended, discrepant, or not documented; not discovered prior to component preparation; Overbleed; not discovered prior to component preparation Sharon O'Callaghan

  11. Component Preparation CP-51-** Sterility compromised Air contamination CP-52-** Component not prepared in accordance with specifications Platelets made from WB-donor took medication that may affect platelet function; Resting time requirements not met for Platelets; Platelets not agitated; Platelet count/yield not acceptable; Processed at incorrect centrifuge setting; Product not frozen within the appropriate time frame; Product prepared or held at incorrect temperature; Components not prepared within appropriate time frame after collection; Additive solution not added, added incorrectly, or added to incorrect product or expired additive solution CP-53-** Component prepared from Whole Blood unit that was Overweight; Underweight; Collected or stored at unacceptable or undocumented temperature; A difficult collection or had an extended collection time CP-54-** Component manufactured that was Overweight; Underweight Sharon O'Callaghan

  12. Donor Deferral Donor missing or incorrectly identified on deferral list, donor was or should have been previously deferred DD-31** due to testing DD-32** due to history Donor incorrectly deleted from deferral list or donor not reentered properly, donor previously deferred DD-34** due to testing DD-35** due to history Sharon O'Callaghan

  13. Donor Screening DS21** Donor did not meet acceptance criteria; temperature, medical review or physical DS2203 Donor history record incomplete or incorrect-donor history questions DS23-25 Deferral screening not done or incorrectly performed; donor not deferred; deferred due to testing or history DS27/ 28 Incorrect ID used during deferral search donor deferred due to testing or history DS-29** Donor gave history which warranted deferral, donor not deferred

  14. Testing VT71** Testing performed, interpreted or documented incorrectly VT72** Sample identification QC92** QC & Distribution; Positive testing QC93** QC & Distribution; Testing not performed, incompletely performed or not documented Note: Testing includes HIV, HBV, HCV, HTLV, Syphilis Sharon O'Callaghan

  15. Quality Control & Distribution QC91** Failure to quarantine unit due to medical history QC9402/04 Distribution of product that did not meet specifications Outdated product; Product QC unacceptable QC9412-17 Failure to quarantine due to collection, component prep, donor screening, donor deferral, shipping or storage deviation/unexpected event QC96** Shipping and storage stored at incorrect temperature; product returned and reissued inappropriately (includes QC-97-18)

  16. Contributing Factors Licensed Blood Establishments Sharon O'Callaghan

  17. Contributing FactorsUnlicensed Registered Blood Establishments Sharon O'Callaghan

  18. Contributing FactorsTransfusion Services Sharon O'Callaghan

  19. Closing Thoughts • BPD Data has value • For FDA - for public health planning and regulatory focus • For Industry - identify issues and track effectiveness of corrective actions • Based on BPD Data, most QREs result from human errors/process controls Sharon O'Callaghan

  20. QUESTIONS????

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