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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

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
Agenda
  • Overview of BPD Reports
  • BPDs identified as QREs
  • Contributing Factors

Sharon O'Callaghan

biological product deviation bpd data
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

quarantine release errors qres
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

bpd reports received fy06 fy10 licensed blood establishments
BPD Reports Received FY06-FY10Licensed Blood Establishments

Total BPDRs (133,164) includes Labeling, Miscellaneous, Post Donation and Routine Testing - not shown

Sharon O'Callaghan

bpd reports received fy06 fy10 unlicensed registered blood establishments
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

bpd reports received fy06 fy10 transfusion services
BPD Reports Received FY06-FY10Transfusion Services

Total BPDRs (8,857) includes Labeling and Routine Testing - not shown

Sharon O'Callaghan

blood collection
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Blood drawn into outdated bag; Incorrect collection bag used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

component preparation
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

donor deferral
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

donor screening
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

testing
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

quality control distribution
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)

contributing factors unlicensed registered blood establishments
Contributing FactorsUnlicensed Registered Blood Establishments

Sharon O'Callaghan

closing thoughts
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