Biological Product Deviation Reports

Annual Summary for Fiscal Year 2003

Table of Contents

  1. Executive Summary
  2. FY03: BPD Reports Submitted by Blood and Plasma Establishments
    1. Most Frequent BPD Reports Submitted by Licensed Blood Establishments
    2. Most Frequent BPD Reports Submitted by Unlicensed Blood Establishments
    3. Most Frequent BPD Reports Submitted by Transfusion Services
    4. Most Frequent BPD Reports Submitted by Plasma Centers
    5. Timeliness of BPD Reports
  3. FY03: BPD Reports Submitted by Manufacturers of Biological Products Other than Blood and Blood Components
  4. Attachments
    1. Number of BPD Reports by Type of Blood Establishment
    2. List of BPD Codes for Blood and Plasma
    3. Number of BPD Reports by Type of Non-Blood Manufacturer
    4. List of BPD Codes for Non-Blood Manufacturers
  1. Executive Summary:
    2.

    On November 7, 2000, FDA published a final rule that requires reporting of Biological Product Deviations (BPD), with an implementation date of May 7, 2001. BPD Reports must be submitted to the Center for Biologics Evaluation and Research (CBER) by licensed manufacturers of blood and blood components, including Source Plasma; unlicensed registered blood establishments; transfusion services who had control over the product when the deviation occurred (21 CFR 606.171), and by the non-blood manufacturer who holds the biological product license for and had control over the product when the deviation occurred (21 CFR 600.14). Detailed information concerning BPD reporting is available at www.fda.gov/cber/biodev/biodev.htm.

    From October 1, 2002 through September 30, 2003 (Fiscal Year 2003 or FY03), CBER's Office of Compliance and Biologics Quality/Division of Inspections and Surveillance received 40,835 BPD reports:

    • We received more than 40,835 reports, but reports that did not meet the threshold for reporting were not captured in the database for FY03
    • 40,496 reports were from blood and plasma establishments, an increase of 21.0% over FY02
    • The number of reporting blood establishments increased by 3.3% over FY02
    • 339 reports were submitted by non-blood manufacturers of biological products (allergenic, in-vitro diagnostic, therapeutic, derivative, or vaccine), a decrease of 28.8% below FY02
    • 2,305 (5.6%) of the reports were sent to FDA District Offices for follow-up/evaluation as potential recall situations
    • 17,843 (43.7%) of the reports were submitted using the new electronic reporting website which was made available June 18, 2001
    • Post-donation information (PDI) continues to be the most common reported event for blood and plasma establishments (74.9% of reportable BPDs). In 91.9% of the reports the donor was aware of the information at the time they were interviewed, but the information was not made available at that time. Most often (92%), the blood collector is made aware at a subsequent donation.

    BPD reports must be submitted within 45 calendar days of the date of discovery of the reportable event. For FY03, 82.4% of the blood BPD reports and 63.1% of the non-blood BPD reports were submitted within 45 days. FDA reviews reporting practices during establishment inspections and we continue to publicize reporting requirements through professional meetings and publications.

    FDA published two draft guidance documents in FY01 to assist industry in determining what events are reportable. 1, 2 We are evaluating the comments received concerning these drafts and anticipate publication of final guidance in the near future.

    Questions concerning this summary may be submitted to:

    FDA/Center for Biologics Evaluation and Research
    Office of Compliance and Biologics Quality
    Division of Inspections and Surveillance (HFM-650)
    1401 Rockville Pike, Suite 200 North
    Rockville, Maryland 20852-1448

    You may also contact us by email at bp_deviations@cber.fda.gov, ocallaghan@cber.fda.gov (Sharon O'Callaghan), or cannon@cber.fda.gov (Sue Cannon) or by phone at 301-827-6220.

    Attachments:

    1. Table - Number of BPD Reports by Type of Blood Establishment
    2. List of BPD Codes for Blood and Plasma
    3. Table - Number of BPD Reports by Type of Non-Blood Manufacturer
    4. List of BPD Codes for Non-Blood Manufacturers
    1. Draft Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments - 8/11/2001
    2. Draft Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components - 8/11/2001

    FY03
    Total BPD Reports

      NUMBER OF REPORTING ESTABLISHMENTS TOTAL REPORTS RECEIVED POTENTIAL RECALLS
    BLOOD/PLASMA MANUFACTURERS  
    LICENSED BLOOD ESTABLISHMENTS 236 / 125 * 28,361 1,598 5.6%
    UNLICENSED BLOOD ESTABLISHMENTS 1 374 3,022 53 1.8%
    TRANSFUSION SERVICES 2 499 1,502 0 0%
    PLASMA CENTERS 378 / 59 * 7,611 635 8.3%
    SUB-TOTAL 1,487 40,496 2,286 5.6%
    NON-BLOOD MANUFACTURERS  
    ALLERGENICS MANUFACTURER 9 165 3 1.8%
    BLOOD DERIVATIVE MANUFACTURER 19 56 5 8.9%
    IN-VITRO DIAGNOSTIC MANUFACTURER 7 44 4 28.6%
    THERAPEUTIC MANUFACTURER 9 18 2 11.1%
    VACCINE MANUFACTURER 12 56 5 8.9%
    SUB-TOTAL 56 339 19 5.6%
    TOTAL 1,543 40,835 2,305 5.6%

    1 Unlicensed Blood Establishments - unlicensed blood establishments performing manufacturing of blood and blood components that require registration with FDA
    2 Transfusion Service - blood banks that perform limited blood and blood component manufacturing (e.g. pooling, thawing, compatibility testing), may or may not be registered with FDA.
    * Number of license holders; one or more establishments operate under one biologics license.

    Total BPD Reports
    FY01 - FY03

      NUMBER OF REPORTING ESTABLISHMENTS TOTAL REPORTS RECEIVED POTENTIAL RECALLS
    BLOOOD / PLASMA MANUFACTURERS FY01 FY02 FY03 FY01 FY02 FY03 FY01 FY02 FY03
    LICENSED BLOOD ESTABLISHMENTS 376 / 123* 224 / 169* 236 / 125* 19,398 21,852 28,361 1,406 1,481 1,598
    UNLICENSED BLOOD ESTABLISHMENTS 247 383 374 1,039 5,142 3,022 22 157 53
    TRANSFUSION SERVICES 277 472 499 519 1,304 1,502 0 2 0
    PLASMA CENTERS 345 / 44* 361 / 62* 378 / 59* 4,013 5,168 7,611 242 533 635
    SUB-TOTAL 1,245 1,440 1,487 24,969 33,466 40,496 1,670 2,173 2,286
    NON-BLOOD MANUFACTURERS  
    ALLERGENIC 9 8 9 243 273 165 13 14 3
    DERIVATIVE 15 17 19 56 45 56 4 5 5
    IN-VITRO DIAGNOSTIC 9 11 7 28 93 44 18 13 4
    THERAPEUTIC 11 13 9 19 23 18 7 4 2
    VACCINE 11 10 12 52 42 56 1 4 5
    SUB-TOTAL 55 59 56 398 476 339 43 40 19
    TOTAL 1,300 1,499 1,543 25,367 33,942 40,835 1,713 2,213 2,305

    * Number of license holders; one or more establishments operate under one biologics license.

    Blood & Plasma BPDs By Manufacturing System
    FY01 - FY03

    MANUFACTURING SYSTEM FY01 FY02 FY03
    DONOR SUITABILITY 19,556 82.1% 25,312 75.6% 32,443 80.1%
        POST DONATION INFORMATION 18,256 76.6% 23,162 69.2% 30,321 74.9%
        DONOR SCREENING 1,210 5.1% 2,032 6.1% 2,030 5.0%
        DONOR DEFERRAL 90 0.4% 118 0.4% 92 0.2%
    QC & DISTRIBUTION 1,892 7.9% 3,875 11.6% 2,705 6.7%
    LABELING 1,313 5.5% 2,367 7.1% 2,430 6.0%
    COLLECTION 624 2.6% 207 0.6% 1,133 2.8%
    PRODUCT TESTING 542 1,120 3.3% 1,126 2.8%
        ROUTINE TESTING 82 0.3% 1,039 3.1% 1,037 2.6%
        VIRAL TESTING 264 1.1% 81 0.2% 89 0.2%
    COMPONENT PREPARATION 150 0.6% 424 1.3% 371 0.9%
    MISCELLANEOUS 40 0.2% 161 0.5% 288 0.7%
    TOTAL 23,839 100% 33,466 100% 40,496 100%

    Non-Blood BPDs By Manufacturing System
    FY01 - FY03

    MANUFACTURING SYSTEM Allergenic Derivative In-Vitro Diagnostic
      FY01 FY02 FY03 FY01 FY02 FY03 FY01 FY02 FY03
    Incoming Material 2 1 1 8 3 3 0 2 3
    Process Controls 6 0 0 6 7 6 4 30 9
    Testing 1 2 0 1 4 8 1 11 7
    Labeling 27 29 5 7 4 1 10 11 10
    Product Specifications 183 225 158 23 20 31 6 29 9
    Quality Control & Distribution 5 15 1 11 7 7 5 7 5
    Miscellaneous 0 1 0 0 0 0 1 3 1
    TOTAL 224 273 165 56 45 56 27 93 44

     

    MANUFACTURING SYSTEM Therapeutic Vaccine Total
      FY01 FY02 FY03 FY01 FY02 FY03 FY01 FY02 FY03
    Incoming Material 1 2 4 1 0 4 12 8 15
    Process Controls 2 7 5 5 10 1 23 54 21
    Testing 0 4 3 5 10 12 8 31 30
    Labeling 1 1 4 6 3 15 51 48 35
    Product Specifications 10 6 1 32 17 21 254 297 220
    Quality Control & Distribution 3 3 1 1 2 2 25 34 16
    Miscellaneous 0 0 0 1 0 1 2 4 2
    TOTAL 17 23 18 51 42 56 375 476 339

    The on-line electronic BPD report form was implemented on June 18, 2001. 43.7% of the reports received in FY03 were submitted electronically, the second full fiscal year during which electronic reports were available. The number of reports submitted electronically in FY03 increased by 10% from FY02. We encourage all reporters to use the electronic reporting format.

    Reports Submitted Electronically

      Total Reports Number of eBPDRs Percent eBPDRs
    BLOOD / PLASMA MANUFACTURERS  
    LICENSED BLOOD ESTABLISHMENTS 28,361 11,855 41.8%
    UNLICENSED BLOOD ESTABLISHMENTS 3,022 2,546 84.2%
    TRANSFUSION SERVICES 1,502 1,134 75.5%
    PLASMA CENTERS 7,611 2,152 28.3%
    SUB-TOTAL 40,496 17,687 43.7%
    NON-BLOOD MANUFACTURERS  
    ALLERGENIC 165 99 60.0%
    DERIVATIVE 57 11 19.3%
    IN-VITRO DIAGNOSTIC 44 32 72.7%
    THERAPEUTIC 18 9 50.0%
    VACCINE 56 5 8.9%
    SUB-TOTAL 340 156 45.9%
    TOTAL 40,836 17,843 43.7%

    Percent of Electronic BPD Reports

      FY02 FY03
    BLOOD / PLASMA MANUFACTURERS  
    LICENSED BLOOD ESTABLISHMENTS 33.0% 41.8%
    UNLICENSED BLOOD ESTABLISHMENTS 39.2% 84.2%
    TRANSFUSION SERVICES 64.4% 75.5%
    PLASMA CENTERS 17.8% 28.3%
    SUB-TOTAL 32.8% 43.7%
    NON-BLOOD MANUFACTURERS  
    ALLERGENIC 49.5% 60.0%
    DERIVATIVE 6.7% 19.3%
    IN-VITRO DIAGNOSTIC 31.2% 72.7%
    THERAPEUTIC 21.7% 50.0%
    VACCINE 7.1% 8.9%
    SUB-TOTAL 36.8% 45.9%
    TOTAL 32.9% 43.7%

Table of Contents

  1. FY03: BPD Reports Submitted By Blood And Plasma Establishments:
    2.

    Total BPDs By Manufacturing System

    MANUFACTURING SYSTEM LICENSED ESTABLISHMENTS UNLICENSED ESTABLISHMENTS TRANSFUSION SERVICES PLASMA CENTERS TOTAL
    POST DONATION INFORMATION 23,211 373 0 6,737 30,321 74.9%
    QC & DISTRIBUTION 858 1,022 681 144 2,705 6.7%
    LABELING 949 974 500 7 2,430 6.0%
    DONOR SCREENING 1,290 98 0 642 2,030 5.0%
    BLOOD COLLECTION 1,067 59 0 7 1,133 2.8%
    ROUTINE TESTING 310 404 317 6 1,037 2.6%
    COMPONENT PREPARATION 292 72 4 3 371 0.9%
    MISCELLANEOUS 277 0 0 11 288 0.7%
    DONOR DEFERRAL 41 9 0 42 92 0.2%
    VIRAL TESTING 66 11 0 12 89 0.2%
    TOTAL 28,361 3,022 1,502 7,611 40,496 100%

    Potential Recalls By Manufacturing System

    MANUFACTURING SYSTEM LICENSED ESTABLISHMENTS UNLICENSED ESTABLISHMENTS TRANSFUSION SERVICES PLASMA CENTERS TOTAL
    DONOR SCREENING 769 23 0 457 1,249 54.6%
    QC & DISTRIBUTION 304 9 0 106 419 18.3%
    COMPONENT PREPARATION 174 7 0 2 183 8.0%
    POST DONATION INFORMATION 69 1 0 30 100 4.4%
    BLOOD COLLECTION 89 3 0 5 97 4.2%
    LABELING 89 4 0 1 94 4.1%
    VIRAL TESTING 51 3 0 8 62 2.7%
    DONOR DEFERRAL 31 3 0 26 60 2.6%
    ROUTINE TESTING 22 0 0 0 22 1.0%
    TOTAL 1,598 53 0 635 2,286 100%

    Post donation information (PDI) continues to be the most frequently reported event associated with the manufacturing of blood and plasma products. The most common PDI involved donors providing information concerning travel to malarial endemic areas and travel to an area at potential risk for vCJD.

    FY03 Post Donation Information (PDI)

    How Obtained

    PDI OBTAINED THROUGH: LICENSED ESTABLISHMENTS UNLICENSED ESTABLISHMENTS PLASMA CENTERS TOTAL
    SUBSEQUENT DONATION 21,609 333 5,955 27,897 92.0%
    TELEPHONE CALL FROM DONOR 1,219 27 25 1,271 4.2%
    THIRD PARTY (e.g., doctor, family) 383 13 757 1,153 3.8%
    TOTAL 23,211 373 6,737 30,321 100%

     

    THE PDI WAS: LICENSED ESTABLISHMENTS UNLICENSED ESTABLISHMENTS PLASMA CENTERS TOTAL
    KNOWN, BUT NOT PROVIDED AT TIME OF DONATION * 21,084 323 6,468 27,875 91.9%
    NOT KNOWN AT TIME OF DONATION ** 2,127 50 269 2,446 8.1%
    TOTAL 23,211 373 6,737 30,321 100%

    * Known, e.g., travel outside of U.S., tattoo or body piercing, history of cancer
    ** Not known, e.g., post donation illness, cancer diagnosed post donation, sex partner participated in high risk behavior or tested positive

    In FY03, the number of post donation information reports submitted by licensed blood establishments increased by 40.6% over the previous fiscal year. The number of reports in which a donor subsequently provided information regarding travel to a CJD risk area more than doubled. This coincided with the implementation of new donor deferral recommendations published by FDA in January 2002. The reports showed that donors did not provide disqualifying information when they were first presented with the new questions. Instead, donors provided the disqualifying information at a subsequent donation.

    Most Frequent Types of Post Donation Information (PDI)
    From Licensed Blood Establishments

    POST DONATION INFORMATION (PDI)       23,211 (81.8% of all BPDRs) Number of Reports Percent of Total PDI
    Behavior / History 21,072 90.8%
    Risk factors associated with Creutzfeldt-Jakob Disease (CJD) - travel 7,794 33.6%
    Travel to malaria endemic area/history of malaria 5,016 21.6%
    History of cancer 1,258 5.4%
    Donor received tattoo within 12 months of donation 715 3.1%
    History of disease 623 2.7%
    Received Proscar, Tegison or Accutane 588 2.5%
    Donor received bone graft or transplant 507 2.2%
    IV drug use 450 1.9%
    Male donor had sex with another man 411 1.8%
    Received medication or antibiotics 405 1.7%
    Illness 1,768 7.6%
    Post donation illness (not hepatitis, HIV, HTLV-I, STD, or cold/flu related) 1,174 5.1%
    Post donation diagnosis of cancer 527 2.3%
    Testing * 274 1.18%
    Tested positive for hepatitis not specified, prior to donation 77 0.3%
    Not specifically related to high risk behavior 97 0.4%
    Donated to be tested or called back for test results 47 0.2%
    Donor does not want their blood used 40 0.2%

    * Includes: tested positive for viral marker either prior to or post donation

    In FY03, the number of reports submitted by licensed blood establishments involving donor screening deviations and unexpected events was relatively consistent with the previous fiscal year. However, the number of reports involving donors who provided information regarding travel to CJD risk areas and were not deferred increased from the previous fiscal year. 30 reports were received in FY02 and 115 reports were received in FY03. This coincided with an increase in deviations associated with the implementation of the change in deferral criteria recommended in January 2002 by FDA.

    Most Frequent Types of Donor Screening BPDs
    From Licensed Blood Establishments

    DONOR SCREENING         1,290 (4.5% of all BPDRs) Number of Reports Percent of Total Donor Screening
    Donor gave history which warranted deferral and was not deferred 727 56.4%
    Travel to malaria endemic area/history of malaria 359 27.8%
    Risk factors associated with Creutzfeldt-Jakob Disease (vCJD) - travel 115 8.9%
    Received medication or antibiotics 68 5.3%
    History of cancer 47 3.6%
    History of disease 37 2.9%
    Donor record incomplete, incorrect, or not reviewed 287 22.2%
    Donor history questions 233 18.1%
    Donor identification 17 1.3%
    Donor signature 16 1.2%
    Arm inspection 11 0.9%
    Incorrect ID used during deferral search 195 15.1%
    >Donor not previously deferred 166 12.9%
    Donor previously deferred due to history 19 1.5%
    Donor previously deferred due to testing 10 0.8%
    Donor did not meet acceptance criteria 50 3.9%
    Hemoglobin or Hematocrit unacceptable or not documented 20 1.6%
    Temperature unacceptable or not documented 11 0.9%
    Deferral screening not done 28 2.2%
    Donor previously deferred due to history 24 1.9%
    Donor previously deferred due to testing 3 0.2%
    Donor not previously deferred 1 0.1%

    In FY03, the number of reports submitted by licensed blood establishments involving blood collection deviations and unexpected events increased by more than 500% from the previous fiscal year. This was primarily due to the reclassification of two events that were previously categorized under Quality Control (QC) and Distribution. In FY02, the distribution of units that were subsequently determined to contain clots or to be hemolyzed were categorized as the distribution of unsuitable product (QC-95-**). In FY03, the distribution of clotted units was categorized under Blood Collection because the clotting process generally occurs during the collection of the unit and not later in the manufacturing process. The distribution of hemolyzed units was also categorized under Blood Collection, unless there was a manufacturing problem identified subsequent to collection, (e.g., stored at incorrect temperature).

    Most Frequent Types of Blood Collection BPDs
    From Licensed Blood Establishments

    BLOOD COLLECTION         1,067 (3.8% of all BPDRs) Number of Reports Percent of Total Blood Collection
    Collection Process 851 79.8%
    Product contained clots, not discovered prior to distribution 672 63.0%
    Product hemolyzed, not discovered prior to distribution 136 12.7%
    Sterility compromised 117 11.0%
    Bacterial contamination 74 6.9%
    Arm prep not performed or performed inappropriately 23 2.2%
    Collection Bag 34 3.2%
    Apheresis collection device 8 0.8%

    In FY03, the number and distribution of reports submitted by licensed blood establishments involving labeling deviations and unexpected events were similar to the reports received in the previous fiscal year.

    Most Frequent Types of Labeling BPDs
    From Licensed Blood Establishments

    Labeling         949 (3.3% of all BPDRs) Number of Reports Percent of Total Labeling
    Blood unit labels 502 52.9%
    Volume incorrect or missing 114 12.0%
    Extended expiration date or time 108 11.4%
    ABO and/or Rh incorrect 73 7.7%
    Donor number incorrect or missing 60 6.3%
    Crossmatch tag or tie tag labels incorrect or missing information 409 43.1%
    Recipient identification missing or incorrect 282 29.7%
          Autologous unit 158 16.6%
    Unit or pool number incorrect or missing 21 2.2%
    Antigen incorrect or missing 18 1.9%
    CMV status incorrect or missing 12 1.3%
    Transfusion record (crossmatch slip) incorrect or missing information 34 3.6%
    Recipient identification missing or incorrect 11 1.2%

    In FY03, the number of reports submitted by licensed blood establishments involving quality control and distribution deviations and unexpected events decreased by 60.4% from the previous fiscal year. This was primarily due to the reclassification of two events that were previously categorized under Quality Control (QC) and Distribution. In FY02, the distribution of units that were subsequently determined to contain clots or to be hemolyzed were categorized as the distribution of unsuitable product (QC-95-**). In FY03, the distribution of clotted units was categorized under Blood Collection because the clotting process generally occurs during the collection of the unit and not later in the manufacturing process. The distribution of hemolyzed units was also categorized under Blood Collection, unless there was a manufacturing problem identified subsequent to collection, (e.g., stored at incorrect temperature).

    Most Frequent Types of Quality Control & Distribution BPDs
    From Licensed Blood Establishments

    QC & Distribution         858 (3.0% of all BPDRs) Number of Reports Percent of Total QC & Distribution
    Inappropriate release of: 410 47.8%
    Product with unacceptable, undocumented or incomplete product QC 97 11.3%
          Platelet count 24 2.8%
          White Blood Cell count 22 2.6%
    Product associated with product that contained clots or hemolysis 86 10.0%
    Product in which instrument QC or validation was unacceptable or not documented 50 5.8%
    Product released prior to resolution of discrepancy 49 5.7%
    Shipping and storage 195 22.7%
    Shipped at incorrect temperature 52 6.1%
    Stored at incorrect temperature 33 3.8%
    Improper blood bank practices 117 13.6%
    Failure to quarantine unit due to testing not performed or documented 50 5.8%
    Failure to quarantine unit due to medical history: 49 5.7%
    Post donation illness 16 1.9%
    Failure to quarantine unit due to incorrect, incomplete, or positive testing 37 4.3%

    Table of Contents

    In FY03, the number and distribution of reports submitted by unlicensed blood establishments involving quality control and distribution deviations and unexpected events were similar to the reports received in the previous fiscal year.

    Most Frequent Types of Quality Control & Distribution BPDs
    From Unlicensed Blood Establishments

    QC & Distribution         1,022 (33.8% of all BPDRs) Number of Reports Percent of Total QC & Distribution
    Improper blood bank practices 681 66.6%
    Product not irradiated as required 201 19.7%
    Procedure for issuing not performed or documented in accordance with specifications 86 8.4%
    Improper ABO or Rh type selected for patient 69 6.8%
    Improper product selected for patient 67 6.6%
    Unit issued from the blood bank to wrong patient 59 5.8%
    Unit released prior to obtaining current sample for ABO, Rh, antibody screen and/or crossmatch testing 51 5.0%
    Failure to quarantine unit due to testing not performed or documented for: 166 16.2%
    Antigen screen 43 4.2%
    Antibody screen or identification 42 4.1%
    Crossmatch 41 4.0%
    Inappropriate release of: 80 7.8%
    Outdated product 27 2.6%
    Product in which instrument QC or validation unacceptable or not documented 19 1.9%
    Product with unacceptable or undocumented product QC 8 0.8%
    Failure to quarantine due to incorrect, incomplete, or positive testing: 54 5.3%
    Antibody screen or identification 27 2.6%
    Shipping and storage 33 3.2%
    Stored at incorrect temperature 16 1.6%
    Shipped at incorrect temperature 6 0.6%

    In FY03, the number and distribution of reports submitted by unlicensed blood establishments involving labeling deviations and unexpected events were similar to the reports received in the previous fiscal year.

    Most Frequent Types of Labeling BPDs
    From Unlicensed Blood Establishments

    Labeling         974 (32.2% of all BPDRs) Number of Reports Percent of Total Labeling
    Crossmatch tag or tie tag labels incorrect or missing information 435 44.7%
    Recipient identification incorrect or missing 133 13.7%
    Crossmatch tag switched, both units intended for the same patient 74 7.6%
    Unit or pool number incorrect or missing 41 4.2%
    Crossmatch tag incorrect or missing 36 3.7%
    Unit ABO and/or Rh incorrect or missing 34 3.5%
    Expiration date or time extended or missing 34 3.5%
    Blood unit labels 277 28.4%
    Extended expiration date or time 124 12.7%
    ABO and/or Rh incorrect 43 4.4%
    Donor number incorrect or missing 36 3.7%
    Missing expiration date or time 15 1.5%
    Transfusion record (crossmatch slip) incorrect or missing information 261 26.8%
    Recipient identification incorrect or missing 78 8.0%
    Unit or pool number incorrect or missing 38 3.9%
    Transfusion record switched, both units intended for the same patient 27 2.8%
    Expiration date or time extended or missing 24 2.5%

    In FY03, the number and distribution of reports submitted by unlicensed blood establishments involving routine testing deviations and unexpected events were similar to the reports received in the previous fiscal year.

    Most Frequent Types of Routine Testing BPDs
    From Unlicensed Blood Establishments

    Routine Testing         404 (13.4% of all BPDRs) Number of Reports Percent of Total Routine Testing
    Incorrectly tested for: 239 59.2%
    Compatibility 77 19.1%
    Antibody screening or identification 69 17.1%
    Antigen typing 25 6.2%
    Rh 24 5.9%
    ABO 18 4.5%
    Sample (used for testing) identification 135 33.4%
    Sample incorrectly or incompletely labeled 102 25.2%
    Incorrect sample tested 18 4.5%
    Unsuitable sample used for testing (e.g., too old) 12 3.0%
    Reagent QC unacceptable or expired reagents used 30 7.4%
    ABO 5 1.2%
    Antibody screening or identification 5 1.2%
    Antigen typing 5 1.2%
    Multiple testing 5 1.2%

    In FY03, the number of post donation information reports submitted by unlicensed blood establishments decreased by 83.7% from the previous fiscal year. In FY02, FDA received reports from registered blood establishments located outside of the United States, which did not distribute any blood or blood components to the United States. These establishments submitted the majority of the post donation reports received in FY02. An exemption to the requirement for reporting biological product deviations (BPD) was requested and granted to those who do not distribute product in the U.S. Therefore these establishments are no longer reporting BPDs.

    Most Frequent Types of Post Donation Information (PDI)
    From Unlicensed Blood Establishments

    POST DONATION INFORMATION (PDI)       373 (12.3% of all BPDRs) Number of Reports Percent of Total PDI
    Behavior/History 327 87.7%
    Travel to malaria endemic area/history of malaria 114 30.6%
    Risk factors associated with Creutzfeldt-Jakob Disease (CJD) - travel 101 27.1%
    History of cancer 13 3.5%
    History of disease or surgery 10 2.7%
    Illness 28 7.5%
    Post donation illness (not hepatitis, HIV, HTLV-I, STD, or cold/flu related) 17 4.6%
    Post donation diagnosis of cancer 10 2.7%
    Testing 18 4.8%

    Table of Contents

    In FY03, the number of reports submitted by transfusion services involving quality control and distribution deviations and unexpected events increased by 31.7% from the previous fiscal year. There was an increase in deviations and unexpected events in which required testing was not performed or documented for antibody screening and compatibility testing prior to distribution of products.

    Most Frequent Types of Quality Control & Distribution BPDs
    From Transfusion Services

    QC & Distribution         681 (45.3% of all BPDRs) Number of Reports Percent of Total QC & Distribution
    Distribution procedures not performed in accordance with blood bank transfusion service's specifications 437 64.2%
    Procedure for issuing not performed or documented in accordance with specifications 116 17.0%
    Product not irradiated as required 73 10.7%
    Improper ABO or Rh type selected for patient 42 6.2%
    Unit released prior to obtaining current sample for ABO, Rh, antibody screen and/or crossmatch testing 32 4.7%
    Improper product selected for patient 31 4.6%
    Failure to quarantine unit due to testing not performed or documented for: 141 20.7%
    Antibody screen or identification 47 6.9%
    Antigen screen 40 5.9%
    Crossmatch 30 4.4%
    Inappropriate release of: 36 5.3%
    Outdated product 26 3.8%
    Product in which instrument QC or validation unacceptable or not documented 3 0.4%
    Shipping and storage 35 5.1%
    Stored at incorrect temperature 13 1.9%
    Product not packaged in accordance with specifications 9 1.3%
    Shipped at incorrect temperature 8 1.2%
    Failure to quarantine due to incorrect, incomplete, or positive testing: 32 4.7%
    Antibody screen or identification 20 2.9%

    In FY03, the number of reports submitted by transfusion services involving labeling deviations and unexpected events increased by 21.3% from the previous fiscal year. There was an increase in the reports of deviations and unexpected events associated with the labeling of transfusion record or crossmatch slip, specifically the recipient identification information and the unit number were either missing or incorrect.

    Most Frequent Types of Labeling BPDs
    From Transfusion Services

    Labeling         500 (33.3% of all BPDRs) Number of Reports Percent of Total Labeling
    Crossmatch tag or tie tag labels incorrect or missing information 276 55.2%
    Recipient identification incorrect or missing 85 17.0%
    Crossmatch tag switched, both units intended for the same patient 53 10.6%
    Unit or pool number incorrect or missing 48 9.6%
    Crossmatch tag incorrect or missing 20 4.0%
    Expiration date or time extended or missing 15 3.0%
    Unit ABO and/or Rh incorrect or missing 15 3.0%
    Transfusion record (crossmatch slip) incorrect or missing information 151 30.2%
    Recipient identification incorrect or missing 63 12.6%
    Unit or pool number incorrect or missing 30 6.0%
    Transfusion record switched, both units intended for the same patient 15 3.0%
    Blood unit labels 73 14.6%
    Expiration date or time extended or missing 35 7.0%
    ABO and/or Rh incorrect 11 2.2%
    Donor number incorrect or missing 11 2.2%

    In FY03, the number and distribution of reports submitted by transfusion services involving routine testing deviations and unexpected events were similar to the reports received in the previous fiscal year.

    Most Frequent Types of Routine Testing BPDs
    From Transfusion Services

    Routine Testing         317 (21.1% of all BPDRs) Number of Reports Percent of Total Routine Testing
    Incorrectly tested for: 166 52.4%
    Antibody screening or identification 63 19.9%
    Compatibility 42 13.3%
    Rh 17 5.4%
    Antigen typing 17 5.4%
    Sample (used for testing) identification 129 40.7%
    Sample incorrectly or incompletely labeled 100 31.6%
    Incorrect sample tested 20 6.3%
    Reagent QC unacceptable or expired reagents used 22 6.9%
    Antibody screening or identification 6 1.9%
    Antigen typing 9 2.8%
    ABO and Rh 4 1.3%

    Table of Contents

    In FY03, the number of post donation information reports submitted by Source Plasma centers increased by 54.6% from the previous fiscal year. There was a 10-fold increase in the number of reports in which a donor subsequently provide disqualifying information regarding travel to CJD risk areas, as well as an increase in post donation information related to tattoos, piercing, and incarceration.

    Most Frequent Types of Post Donation Information (PDI)
    From Plasma Centers

    POST DONATION INFORMATION (PDI)         6,737 (88.5% of all BPDRs) Number of Reports Percent of Total PDI
    Behavior/History 6,496 96.4%
    Donor received tattoo within 12 months of donation 2,370 35.2%
    Donor received body piercing within 12 months of donation 854 12.7%
    Incarcerated 823 12.2%
    Risk factors associated with Creutzfeldt-Jakob Disease (CJD) - travel 474 7.0%
    Donor received ear piercing within 12 months of donation 292 4.3%
    Non-IV-drug use 221 3.3%
    Donor received tattoo and piercing within 12 months of donation 145 2.2%
    IV drug use 130 1.9%
    Testing * 191 2.8%
    Tested positive at another center, specific testing unknown 113 1.7%

    * Includes testing positive for viral marker prior to or post donation

    In FY03, the number of reports submitted by Source Plasma centers involving donor screening deviations and unexpected events increased by 19.6% from the previous fiscal year. There was an increase in reports of deviations and unexpected events associated with donor records; specifically the answers to donor history questions were missing or incomplete. There was also an increase in the number of reports involving donors who provided information of travel to CJD risk areas and were not deferred. Two reports were received in FY02 and 30 reports were received in FY03. This coincided with an increase in deviations associated with the implementation of the change in deferral criteria recommended in January 2002 by FDA.

    Most Frequent Types of Donor Screening BPDs
    From Plasma Centers

    DONOR SCREENING         642 (8.4% of all BPDRs) Number of Reports Percent of Total DONOR SCREENING
    Donor record incomplete, incorrect, or not reviewed 329 51.3%
    >Donor history questions 259 40.3%
    Arm inspection 31 4.8%
    Donor signature missing 25 3.9%
    Donor identification 13 2.0%
    Donor gave history which warranted deferral and was not deferred 134 20.9%
    Risk factors associated with Creutzfeldt-Jakob Disease (vCJD) - travel 30 4.7%
    Donor received tattoo within 12 months of donation 29 4.5%
    Donor received vaccine or immune globulin 13 2.0%
    Donor received body piercing within 12 months of donation 12 1.9%
    History of disease or surgery 11 1.7%
    Donor did not meet acceptance criteria 102 15.9%
    Temperature unacceptable or not documented 51 7.9%
    Medical review or physical not performed or inadequate 23 3.6%
    Unexplained weight loss 14 2.2%
    Deferral screening not done 67 10.4%
          Donor previously deferred due to history 34 5.3%
    IV drug use 6 0.9%
    Other-unknown 5 0.8%
    Donor received tattoo 4 0.6%
          Donor previously deferred due to testing: 33 5.1%
    Elevated for ALT 18 2.8%
    Incorrect ID used during deferral search 9 1.4%
          Donor previously deferred due to history 6 0.9%
          Donor previously deferred due to testing 3 0.5%

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    BLOOD AND PLASMA ESTABLISHMENTS

    Timeliness Of BPDs
    Number of Days From Date Discovered To Date FDA Received

    CUMULATIVE % OF REPORTS Licensed (Days) Unlicensed (Days) Transfusion Service (Days) Plasma (Days) Total (Days)
    10% 14 5 2 19 12
    25% 20 12 9 31 20
    50% 27 25 24 44 28
    75% 32 42 42 60 39
    90% 44 65 56 131 58
    # REPORTS 28,361 3,022 1,502 7,611 40,496
    RANGE 0-837 0-805 0-453 0-1,106 0-1,106
    AVERAGE 32 35 34 66 47
    # Reports lacking date discovered 1 0 0 0 1

    Adherence To 45 Day Required Timeframe For Reporting
    (Reporting Time = Date of FDA receipt - Date of discovery of BPD)

    Reporting Time (days) Licensed Establishments Unlicensed Establishments Transfusion Services Plasma Centers Total
    < or = 45 25,626 90.4% 2,415 79.9% 1,210 80.6% 4,132 54.3% 33,383 82.4%
    Between 45 and 90 2,057 7.3% 429 14.2% 214 14.2% 2,106 27.7% 4,806 11.9%
    > 90 677 2.4% 178 5.9% 78 5.2% 1,373 18.0% 2,306 5.7%
    Total 28,361 100% 3,022 100% 1,502 100% 7,611 100% 40,496 100%
    * Reporting time=0 34   43   47   1   125  

    *Reporting time = 0 - reports were submitted electronically on the day discovered.

    Graph of FY03 Blood and Plasma Reporting Time in Days

    Graph of FY03 Blood and Plasma Establishments Reporting Time - Total Reports

    Graph of FY03 Blood and Plasma Establishments Reporting Time - Potential Recalls

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  2. FY03: BPD Reports Submitted by Manufacturers of Biological Products Other Than Blood and Blood Components (Non-Blood)
    3.

    The number of reports submitted by non-blood manufacturers decreased by 28.8% from the previous fiscal year. There was 52.7% decrease in the number of reports submitted by In-Vitro Diagnostic manufacturers and a 39.6% decrease in reports submitted by Allergenic manufacturers. The number and distribution of reports submitted in FY03 were similar to the reports submitted in FY01. 376 reports were submitted in FY01.

    Total BPDs By Manufacturing System

    MANUFACTURING SYSTEM ALLERGENIC DERIVATIVE IN-VITRO DIAGNOSTIC THERAPEUTIC VACCINE TOTAL
    Incoming Material 1 3 3 4 4 15 4.4%
    Process Controls 0 6 9 5 1 21 6.2%
    Testing 0 8 7 3 12 30 8.8%
    Labeling 5 1 10 4 15 35 10.3%
    Product Specifications 158 31 9 1 21 220 64.9%
    Quality Control & Distribution 1 7 5 1 2 16 4.7%
    Miscellaneous 0 0 1 0 1 2 0.6%
    Total 165 56 44 18 56 339 100%

    Potential Recalls By Manufacturing System

    MANUFACTURING SYSTEM ALLERGENIC DERIVATIVE IN-VITRO DIAGNOSTIC THERAPEUTIC VACCINE TOTAL
    Incoming Material 1 1 0 0 0 2 10.5%
    Process Controls 0 0 0 0 0 0 0.0%
    Testing 0 0 0 0 0 0 0.0%
    Labeling 0 0 1 1 1 3 15.8%
    Product Specifications 1 4 2 1 3 11 57.9%
    Quality Control & Distribution 1 0 0 0 0 1 5.3%
    Miscellaneous 0 0 1 0 1 2 10.5%
    Total 3 5 4 2 5 19 100%

    NON-BLOOD MANUFACTURERS

    Timeliness Of BPDs
    Number of Days From Date Discovered To Date FDA Received

    CUMULATIVE PERCENT OF REPORTS Allergenic (Days) Derivative (Days) In-Vitro Diagnostic (Days) Therapeutic (Days) Vaccine (Days) Total (Days)
    10% 20 24 18 2 20 21
    25% 28 38 25 32 27 28
    50% 37 47 34 44 34 41
    75% 47 49 53 47 48 49
    90% 64 60 131 60 68 70
    # REPORTS 165 56 44 18 56 339
    RANGE 15-108 8-149 8-689 2-346 8-665 2-689
    AVERAGE 41 48 85 62 68 53
    # Reports lacking date discovered 0 0 0 0 0 0

    Adherence To 45 Day Required Timeframe For Reporting
    (Reporting Time = Date of FDA receipt - Date of discovery of BPD)

    Reporting Time (days) Allergenics Derivatives In-Vitro Diagnostics Therapeutics Vaccines Total
    < or = 45 116 70.3% 21 37.5% 29 65.9% 11 61.1% 37 66.1% 214 63.1%
    > 45 and <=90 47 28.5% 33 58.9% 6 13.6% 5 27.8% 14 25.0% 105 31.0%
    > 90 2 1.2% 2 3.6% 9 20.5% 2 11.1% 5 8.9% 20 5.9%
    Total 165 100% 56 100% 44 100% 18 100% 56 100% 339 100%

    Graph of FY03 Non-Blood Manufacturers Reporting Time in Days

    Graph of FY03 Non-Blood Manufacturers Reporting Time - Total Reports

    Graph of FY03 Non-Blood Manufacturers Reporting Time - Potential Recalls

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Attachments

Attachment 1 - Number of BPD Reports by Type of Blood Establishment

Attachment 2 - List of BPD Codes for Blood and Plasma

Attachment 3 - Number of BPD Reports by Type of Non-Blood Manufacturer

Attachment 4 - List of BPD Codes for Non-Blood Manufacturers

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Updated: June 15, 2004