Biological Product Deviation Reports
Annual Summary for Fiscal Year 2004
- Executive Summary
- FY04: BPD Reports Submitted by Blood and Plasma Establishments
- Most Frequent BPD Reports Submitted by Licensed Blood Establishments
- Most Frequent BPD Reports Submitted by Unlicensed Blood Establishments
- Most Frequent BPD Reports Submitted by Transfusion Services
- Most Frequent BPD Reports Submitted by Plasma Centers
- Timeliness of BPD Reports
- FY04: BPD Reports Submitted by Manufacturers of Biological Products Other than Blood and Blood Components
- Attachments
- Number of BPD Reports by Type of Blood Establishment
- List of BPD Codes for Blood and Plasma
- Number of BPD Reports by Type of Non-Blood Manufacturer
- List of BPD Codes for Non-Blood Manufacturers
- Executive Summary
- We received more than 38,162 reports, but reports that did not meet the threshold for reporting were not captured in the database and the reporting establishment was notified that a report was not required.
- 37,830 reports were submitted by blood and plasma establishments, which was a decrease of 7% below FY03 (40,496).
- 332 reports were submitted by non-blood manufacturers of biological products (allergenic, in-vitro diagnostic, therapeutic, derivative, or vaccine), which was similar to the number of reports submitted in FY03 (339).
- The number of reporting establishments decreased by 4.1% (1,543 establishments in FY03 and 1,479 establishments in FY04).
- The number of transfusion services reporting in FY04 (468) decreased by 6% below FY03 (499). 208 transfusion services reported in FY03, but did not report in FY04 and 180 reported in FY04, but not in FY03. 68% of the transfusion services reporting in FY03 and FY04 only submitted 1 or 2 reports. Only 11% of the transfusion services submitted more than 5 reports during this reporting period.
- The number of plasma centers (individual registered locations) reporting in FY04 (357) decreased by 6% below FY03 (378), which resulted in a 33% decrease in the number of reports submitted by plasma centers, from 7,611 in FY03 to 5115 in FY04.
- The number of therapeutic biological manufacturers reporting decreased from 9 in FY03 to 1 in FY04 due to the transfer of regulatory responsibility for therapeutic biological products to CDER on June 30, 2003.
- There was an increase of 16% in the number of establishments reporting electronically. In FY04, 66% (970/1479) of the reporting establishments submitted reports electronically. In FY03, 53% (819/1543) of the reporting establishments submitted electronically. We continue to encourage electronic reporting.
- Reports of post-donation information (PDI) continue to represent the largest percentage of reports submitted by blood and plasma establishments (71%). In 88% of the PDI reports the donor was aware of the information at the time they were interviewed, but failed to provide the information during the interview. Most often (91%), the blood collector is made aware during a subsequent donation interview.
- The number of reports submitted by licensed blood establishments involving donor records which were incomplete, incorrect, or not reviewed increased by 71%. Of the 399 reports received in FY04, 60 reports related to use of the abbreviated donor history questionnaire when the full-length questionnaire should have been used.
- There was a 4-fold increase in the number of reports submitted by blood establishments involving the release of a product with unacceptable, undocumented, or incomplete product QC. There were 105 reports submitted in FY03 and 527 reports submitted in FY04. Of the reports submitted in FY04, 280 reports were related to the implementation of bacterial detection testing used as a quality control test.
- 2,623 (7%) of the reports received by CBER were sent to FDA District Offices for follow-up/evaluation as potential recall situations.
- Deviations and unexpected events that occur during the donor screening process continue to be leading cause of potential recall situations (48%).
- Table - Number of BPD Reports by Type of Blood Establishment
- List of BPD Codes for Blood and Plasma
- Table - Number of BPD Reports by Type of Non-Blood Manufacturer
- List of BPD Codes for Non-Blood Manufacturers
- Draft Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments - 8/11/2001
- Draft Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components - 8/11/2001
- FY04: BPD Reports Submitted By Blood And Plasma Establishments
- Most Frequent BPD Reports Submitted by Licensed Blood Establishments
- In FY04, the number of these reports decreased by 5.9% (FY03 - 23,211).
- The number of reports in which a donor subsequently provided information regarding travel to a CJD risk area decreased by 22% (FY03 - 7,794).
- The number of reports in which a donor reported a subsequent diagnosis of cancer increased by 38% (FY03 - 527).
- In FY04, the number of these reports increased by 25% (FY03 - 1,290).
- The number of reports involving donor records which were incomplete, incorrect or not reviewed, specifically related to the donor history questions increased from 233 in FY03 to 399 in FY04.
- There were 60 reports related to the use of an abbreviated donor history questionnaire when a full-length questionnaire should have been used.
- In FY04, the number of these reports increased by 69.2% (FY03 - 858).
- The number of reports involving the release of a product with unacceptable, undocumented, or incomplete product QC increased more than 3-fold (FY03 - 97). This was primarily due to the implementation of bacterial detection testing used as a quality control test.
- In FY04, the number and distribution of these reports were similar to the reports received in the previous two fiscal years (FY02 - 948 ; FY03 - 949).
- In FY04, the number of these reports decreased by 25% (FY03 -1,067).
- The number of reports in which a clotted product was discovered after distribution decreased from 672 in FY03 to 511 in FY04.
- Most Frequent BPD Reports Submitted by Unlicensed Blood Establishments
- In FY04, the number of these reports increased by 35% (FY03 - 1,022). This increase was due to an increase in the number of reports in which a product was not documented as issued in the computer. This type of event is reportable if the computer system is used as the only documentation of the final checks of the issue process.
- The number of reports involving the release of a product with unacceptable, undocumented or incomplete product QC, specifically associated with the implementation of bacterial detection testing used as a quality control test, increased from 8 reports in FY03 to 46 reports (27 reports involved bacterial detection testing) in FY04.
- In FY04, the number of these reports increased by 8% (FY03 - 974).
- There was an increase in the number of reports in which the recipient identification was incorrect or missing on the crossmatch tag and/or transfusion record, from 211 reports in FY03 to 246 reports in FY04.
- There was an increase in the number of reports in which the crossmatch tag and/or the transfusion record were switched, but both units were intended for the same patient, from 101 reports in FY03 to 139 reports in FY04.
- In FY04, the number of these reports increased by 11% (FY03 - 373).
- The number of reports of post donation illness increased from 28 in FY03 to 71 in FY04.
- In FY04, the number and distribution of these reports were similar to the reports received in the previous fiscal years (FY02 - 407, FY04 - 404).
- Most Frequent BPD Reports Submitted by Transfusion Services
- In FY04, the number of these report was similar to the reports received in the previous fiscal year (FY03 - 681).
- There was an increase in the number of reports in which a product was not documented as issued in the computer. There were 77 reports submitted in FY03 and 208 reports submitted in FY04. This type of event is reportable if the computer system is used as the only documentation of the final checks of the issue process.
- In FY04, the number and distribution of these reports was similar to the reports received in the previous fiscal year (FY03 - 500).
- In FY04, the number of these reports increased 16% (FY03 - 317).
- There was an increase in the number of reports involving testing, specifically antibody screening and compatibility testing performed or documented incorrectly, 117 reports in FY03 and 204 reports in FY04.
- Most Frequent BPD Reports Submitted by Plasma Centers
- In FY04, the number of these reports decreased by 32% (FY03 - 6,737).
- In FY03, 452 reports were submitted by plasma centers that did not submit reports in FY04 due to closure of center.
- There was an increase in the number of reports in which a donor tested positive for Hepatitis B, Hepatitis C, or HIV, post donation. In FY03 there were 32 reports and in FY04 there were 169 reports.
- In FY04, the number of these reports decreased by 56% (FY03 - 642).
- In FY03, 69 reports were submitted by plasma centers that did not report in FY04 due to closure of the center.
- Timeliness of BPD Reports
- FY04: BPD Reports Submitted by Manufacturers of Biological Products Other Than Blood and Blood Components (Non-Blood)
- There was a decrease in the number of reports submitted by therapeutic manufactures, 18 in FY03 and 2 in FY04 due to the transfer of the oversight of these products to CDER on June 30, 2003.
- The number of reports submitted by in-vitro diagnostic manufacturers increased (FY03 - 44), however were similar to the reports submitted in FY02 (93).
- The number of reports submitted by derivative manufactures decreased from the previous fiscal year (FY03 - 56 for both types of manufacturers), however were approximately the same number of reports submitted in FY02 (45 and 42 respectively).
- There was a slight decrease in the number of reports submitted by Allergenic manufacturers (FY03 - 165, FY04 - 158).
- The majority of these reports continue to be related to precipitate discovered in allergenic extracts.
Biological Product Deviations (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, 2003 through September 30, 2004 (Fiscal Year 2004 or FY04), CBER's Office of Compliance and Biologics Quality/Division of Inspections and Surveillance entered 38,162 BPD reports into the BPD database:
BPD reports must be submitted within 45 calendar days of the date of discovery of the reportable event. In FY04, 89% of the blood BPD reports and 69% of the non-blood BPD reports were submitted within 45 days. FDA investigators review 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:
References
FY04
Total BPD Reports
Number of Reporting Establishments | Total Reports Received | Potential Recalls | ||
---|---|---|---|---|
Blood / Plasma Manufacturers | ||||
Licensed Blood Establishments | 237 (117*) | 27,621 | 2,170 | 7.9% |
Unlicensed Blood Establishments 1 | 371 | 3,502 | 58 | 1.7% |
Transfusion Services 2 | 468 | 1,592 | 0 | 0% |
Plasma Centers | 357 (55*) | 5,115 | 377 | 7.4% |
Sub-Total | 1,433 | 37,830 | 2,605 | 6.9% |
Non-Blood Manufacturers | ||||
Allergenic | 9 | 158 | 5 | 3.2% |
Blood Derivative | 17 | 44 | 4 | 9.1% |
In-Vitro Diagnostic | 10 | 86 | 8 | 9.3% |
Therapeutic | 1 | 2 | 0 | 0% |
Vaccine | 9 | 42 | 1 | 2.4% |
Sub-Total | 46 | 332 | 18 | 5.4% |
Total | 1,479 | 38,162 | 2,623 | 6.9% |
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
FY02 - FY04
Number of Reporting Establishments | Total Reports Received | Potential Recalls | |||||||
---|---|---|---|---|---|---|---|---|---|
Blood / Plasma Manufacturers | FY02 | FY03 | FY04 | FY02 | FY03 | FY04 | FY02 | FY03 | FY04 |
Licensed Blood Establishments | 224 (169*) | 236 (125*) | 237 (117*) | 21,852 | 28,361 | 27,621 | 1,481 | 1,598 | 2,170 |
Unlicensed Blood Establishments | 383 | 374 | 371 | 5,142 | 3,022 | 3,502 | 157 | 53 | 58 |
Transfusion Services | 472 | 499 | 468 | 1,304 | 1,502 | 1,592 | 2 | 0 | 0 |
Plasma Centers | 361 (62*) | 378 (59*) | 357 (55*) | 5,168 | 7,611 | 5,115 | 533 | 635 | 377 |
Sub-Total | 1,440 | 1,487 | 1,433 | 33,466 | 40,496 | 37,830 | 2,173 | 2,286 | 2,605 |
Non-Blood Manufacturers | |||||||||
Allergenic | 8 | 9 | 9 | 273 | 165 | 158 | 14 | 3 | 5 |
Blood Derivative | 17 | 19 | 17 | 45 | 56 | 44 | 5 | 5 | 4 |
In-Vitro Diagnostic | 11 | 7 | 10 | 93 | 44 | 86 | 13 | 4 | 8 |
Therapeutic | 13 | 9 | 1 | 23 | 18 | 2 | 4 | 2 | 0 |
Vaccine | 10 | 12 | 9 | 42 | 56 | 42 | 4 | 5 | 1 |
Sub-Total | 59 | 56 | 46 | 476 | 339 | 332 | 40 | 19 | 18 |
Total | 1,499 | 1,543 | 1,479 | 33,942 | 40,835 | 38,162 | 2,213 | 2,305 | 2,623 |
* Number of license holders; one or more establishments operate under one biologics license.
Blood & Plasma BPD Reports By Manufacturing System
FY02 - FY04
Manufacturing System | FY02 | FY03 | FY04 | |||
---|---|---|---|---|---|---|
Donor Suitability | 25,312 | 75.6% | 32,443 | 80.1% | 28,952 | 76.5% |
Post Donation Information | 23,162 | 69.2% | 30,321 | 74.9% | 26,854 | 71.0% |
Donor Screening | 2,032 | 6.1% | 2,030 | 5.0% | 2,007 | 5.3% |
Donor Deferral | 118 | 0.4% | 92 | 0.2% | 91 | 0.2% |
QC & Distribution | 3,875 | 11.6% | 2,705 | 6.7% | 3,740 | 9.9% |
Labeling | 2,367 | 7.1% | 2,430 | 6.0% | 2,415 | 6.4% |
Laboratory Testing | 1,120 | 3.3% | 1,126 | 2.8% | 1,122 | 3.0% |
Routine Testing | 1,039 | 3.1% | 1,037 | 2.6% | 1,027 | 2.7% |
Viral Testing | 81 | 0.2% | 89 | 0.2% | 95 | 0.3% |
Collection | 207 | 0.6% | 1,133 | 2.8% | 851 | 2.2% |
Component Preparation | 424 | 1.3% | 371 | 0.9% | 368 | 1.0% |
Miscellaneous | 161 | 0.5% | 288 | 0.7% | 382 | 1.0% |
Total | 33,466 | 100% | 40,496 | 100% | 37,830 | 100% |
Non-Blood BPD Reports By Manufacturing System
FY02 - FY04
Manufacturing System | Allergenic | Derivative | In-Vitro Diagnostic | ||||||
---|---|---|---|---|---|---|---|---|---|
FY02 | FY03 | FY04 | FY02 | FY03 | FY04 | FY02 | FY03 | FY04 | |
Incoming Material | 1 | 1 | 2 | 3 | 3 | 9 | 2 | 3 | 5 |
Process Controls | 0 | 0 | 2 | 7 | 6 | 9 | 30 | 9 | 20 |
Testing | 2 | 0 | 0 | 4 | 8 | 0 | 11 | 7 | 14 |
Labeling | 29 | 5 | 8 | 4 | 1 | 3 | 11 | 10 | 16 |
Product Specifications | 225 | 158 | 146 | 20 | 31 | 15 | 29 | 9 | 23 |
Quality Control & Distribution | 15 | 1 | 0 | 7 | 7 | 7 | 7 | 5 | 6 |
Miscellaneous | 1 | 0 | 0 | 0 | 0 | 1 | 3 | 1 | 2 |
Total | 273 | 165 | 158 | 45 | 56 | 44 | 93 | 44 | 86 |
Manufacturing System | Therapeutic | Vaccine | Total | ||||||
---|---|---|---|---|---|---|---|---|---|
FY02 | FY03 | FY04 | FY02 | FY03 | FY04 | FY02 | FY03 | FY04 | |
Incoming Material | 2 | 4 | 0 | 0 | 4 | 1 | 8 | 15 | 17 |
Process Controls | 7 | 5 | 1 | 10 | 1 | 7 | 54 | 21 | 39 |
Testing | 4 | 3 | 0 | 10 | 12 | 4 | 31 | 30 | 18 |
Labeling | 1 | 4 | 0 | 3 | 15 | 10 | 48 | 35 | 37 |
Product Specifications | 6 | 1 | 0 | 17 | 21 | 17 | 297 | 220 | 201 |
Quality Control & Distribution | 3 | 1 | 1 | 2 | 2 | 1 | 34 | 16 | 15 |
Miscellaneous | 0 | 0 | 0 | 0 | 1 | 2 | 4 | 2 | 5 |
Total | 23 | 18 | 2 | 42 | 56 | 42 | 476 | 339 | 332 |
The on-line electronic BPD report form was implemented on June 18, 2001. The percentage of reports submitted electronically in FY04 increased by 12.8 percentage points from FY03 (from 43.7% to 56.5%). We continue to encourage all reporters to use the electronic reporting format.
BPD Reports Submitted Electronically
Total Reports | # of eBPDR | % eBPDR | |
---|---|---|---|
Blood / Plasma Manufacturers | |||
Licensed Blood Establishments | 27,621 | 14,391 | 52.1% |
Unlicensed Blood Establishments | 3,502 | 3,114 | 88.9% |
Transfusion Services | 1,592 | 1,304 | 81.9% |
Plasma Centers | 5,115 | 2,537 | 49.6% |
Sub-Total | 37,830 | 21,346 | 56.4% |
Non-Blood Manufacturers | |||
Allergenic | 158 | 129 | 81.6% |
Derivative | 44 | 22 | 50.0% |
In-Vitro Diagnostic | 86 | 56 | 65.1% |
Therapeutic | 2 | 0 | 0.0% |
Vaccine | 42 | 6 | 14.3% |
Sub-Total | 332 | 213 | 64.2% |
Total | 38,162 | 21,559 | 56.5% |
Percent of Electronic BPD Reports
FY02 | FY03 | FY04 | |
---|---|---|---|
Blood / Plasma Manufacturers | |||
Licensed Blood Establishments | 33.0% | 41.8% | 52.1% |
Unlicensed Blood Establishments | 39.2% | 84.2% | 88.9% |
Transfusion Services | 64.4% | 75.5% | 81.9% |
Plasma Centers | 17.8% | 28.3% | 49.6% |
Sub-Total | 32.8% | 43.7% | 56.4% |
Non-Blood Manufacturers | |||
Allergenic | 49.5% | 60.0% | 81.6% |
Derivative | 6.7% | 19.3% | 50.0% |
In-Vitro Diagnostic | 31.2% | 72.7% | 65.1% |
Therapeutic | 21.7% | 50.0% | 0.0% |
Vaccine | 7.1% | 8.9% | 14.3% |
Sub-Total | 36.8% | 45.9% | 64.2% |
Total | 32.9% | 43.7% | 56.5% |
Total BPD Reports By Manufacturing System
Manufacturing System | Licensed Establishments | Unlicensed Establishments | Transfusion Services | Plasma Centers | Total | |
---|---|---|---|---|---|---|
DS - Post Donation Information | 21,840 | 413 | NA | 4,601 | 26,854 | 71.0% |
QC & Distribution | 1,452 | 1,381 | 743 | 164 | 3,740 | 9.9% |
Labeling | 868 | 1,062 | 470 | 15 | 2,415 | 6.4% |
DS - Donor Screening | 1,617 | 105 | NA | 285 | 2,007 | 5.3% |
LT - Routine Testing | 272 | 386 | 369 | 0 | 1,027 | 2.7% |
Blood Collection | 798 | 47 | NA | 6 | 851 | 2.2% |
Miscellaneous | 370 | 2 | 0 | 10 | 382 | 1.0% |
Component Preparation | 277 | 81 | 10 | 0 | 368 | 1.0% |
LT - Viral Testing | 74 | 9 | NA | 12 | 95 | 0.3% |
DS - Donor Deferral | 53 | 16 | NA | 22 | 91 | 0.2% |
Total | 27,621 | 3,502 | 1,592 | 5,115 | 37,830 | 100% |
DS - Donor Suitability
LT - Laboratory Testing
NA - Not applicable: manufacturing not performed in transfusion service
Potential Recalls By Manufacturing System
Manufacturing System | Licensed Establishments | Unlicensed Establishments | Transfusion Services | Plasma Centers | Total | |
---|---|---|---|---|---|---|
DS - Donor Screening | 1,006 | 30 | NA | 221 | 1,257 | 48.3% |
QC & Distribution | 619 | 8 | 0 | 113 | 740 | 28.4% |
Blood Collection | 149 | 1 | NA | 6 | 156 | 6.0% |
Component Preparation | 150 | 2 | NA | 0 | 152 | 5.8% |
Labeling | 93 | 8 | 0 | 2 | 103 | 4.0% |
DS - Post Donation Information | 53 | 0 | NA | 11 | 64 | 2.5% |
DS - Donor Deferral | 37 | 5 | NA | 16 | 58 | 2.2% |
LT - Viral Testing | 42 | 3 | NA | 8 | 53 | 2.0% |
LT - Routine Testing | 20 | 1 | 0 | 0 | 21 | 0.8% |
Miscellaneous | 1 | 0 | 0 | 0 | 1 | 0.0% |
Total | 2,170 | 58 | 0 | 377 | 2,605 | 100% |
DS - Donor Suitability
LT - Laboratory Testing
NA - Not applicable: manufacturing not performed in transfusion service
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.
FY04 Reports of Post Donation Information (PDI)
PDI Obtained Through: | Licensed Establishments | Unlicensed Establishments | Plasma Centers | Total | |
---|---|---|---|---|---|
Subsequent Donation | 19,850 | 355 | 4,145 | 24,350 | 90.7% |
Telephone Call From Donor | 1,523 | 46 | 13 | 1,582 | 5.9% |
Third Party (e.g., doctor, family) | 467 | 12 | 443 | 922 | 3.4% |
Total | 21,840 | 413 | 4,601 | 26,854 | 100% |
The PDI Was: | Licensed Establishments | Unlicensed Establishments | Plasma Centers | Total | |
---|---|---|---|---|---|
Known, but not Provided at Time of Donation * | 19,160 | 311 | 4,086 | 23,557 | 87.7% |
Not Known at Time of Donation ** | 2,680 | 102 | 515 | 3,294 | 12.3% |
Total | 21,840 | 413 | 4,601 | 26,854 | 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
Of the 27,621 reports submitted by licensed blood establishments, 21,840 (79.1%) reports involved post donation information.
Most Frequent BPD Reports - Post Donation Information
From Licensed Blood Establishments
Post Donation Information 21,840 | # Reports | % of Total |
---|---|---|
Behavior / History | 19,174 | 87.8% |
Risk factors associated with Creutzfeldt-Jakob Disease (CJD) - travel | 6,053 | 27.7% |
Travel to malaria endemic area / history of malaria | 5,303 | 24.3% |
History of cancer | 1,187 | 5.4% |
Donor received tattoo within 12 months of donation | 773 | 3.5% |
History of disease | 661 | 3.0% |
Received Proscar, Tegison or Accutane | 536 | 2.5% |
Male donor had sex with another man | 432 | 2.0% |
IV drug use | 418 | 1.9% |
Donor received bone graft or transplant | 353 | 1.6% |
History of Jaundice | 302 | 1.4% |
Illness | 2,175 | 10.0% |
Post donation illness (not hepatitis, HIV, HTLV-I, STD, or cold/flu related) | 1,266 | 5.8% |
Post donation diagnosis of cancer | 728 | 3.3% |
Testing * | 349 | 1.6% |
Tested positive for hepatitis not specified, prior to donation | 60 | 0.3% |
Not specifically related to high risk behavior | 142 | 0.7% |
Donated to be tested or called back for test results | 75 | 0.3% |
Donor does not want their blood used | 62 | 0.3% |
* Includes: tested positive for viral marker either prior to or post donation
Of the 27,621 reports submitted by licensed blood establishments, 1,617 (5.9%) reports involved donor screening deviations and unexpected events.
Most Frequent BPD Reports - Donor Screening
From Licensed Blood Establishments
Donor Screening 1,617 | # Reports | % of Total |
---|---|---|
Donor gave history which warranted deferral and was not deferred | 775 | 48.9% |
Travel to malaria endemic area / history of malaria | 431 | 26.7% |
Risk factors associated with Creutzfeldt-Jakob Disease (vCJD) - travel | 89 | 5.5% |
Received medication or antibiotics | 58 | 3.6% |
History of cancer | 44 | 2.7% |
History of disease | 40 | 2.5% |
Donor record incomplete, incorrect, or not reviewed | 475 | 29.4% |
Donor history questions | 399 | 24.7% |
Donor identification | 37 | 2.3% |
Donor signature | 10 | 0.6% |
Arm inspection | 10 | 0.6% |
Incorrect ID used during deferral search | 278 | 17.2% |
Donor not previously deferred | 216 | 13.4% |
Donor previously deferred due to history | 33 | 2.0% |
Donor previously deferred due to testing | 29 | 1.8% |
Donor did not meet acceptance criteria | 39 | 2.4% |
Hemoglobin or Hematocrit unacceptable or not documented | 20 | 1.2% |
Temperature unacceptable or not documented | 10 | 0.6% |
Deferral screening not done | 49 | 3.0% |
Donor previously deferred due to history | 23 | 1.1% |
Donor previously deferred due to testing | 24 | 1.5% |
Donor not previously deferred | 2 | 0.1% |
Of the 27,621 reports submitted by licensed blood establishments, 1,452 (5.3%) reports involved quality control and distribution deviations and unexpected events.
Most Frequent BPD Reports - Quality Control & Distribution
From Licensed Blood Establishments
QC & Distribution 1,452 | # Reports | % of Total |
---|---|---|
Inappropriate release of: | 966 | 66.5% |
Product with unacceptable, undocumented or incomplete product QC | 471 | 32.4% |
Bacterial Detection Testing | 243 | 16.7% |
Platelet count | 56 | 3.9% |
White Blood Cell count | 42 | 2.9% |
Product in which instrument QC or validation was unacceptable or not documented | 129 | 8.9% |
Product released prior to resolution of discrepancy | 96 | 6.6% |
Product associated with product that contained clots or hemolysis | 81 | 5.6% |
Shipping and storage | 219 | 15.1% |
Product not packaged in accordance with specifications | 56 | 3.9% |
No documentation that product was shipped or stored at appropriate temperature | 50 | 3.4% |
Shipped at incorrect temperature | 49 | 3.4% |
Improper blood bank practices | 127 | 8.8% |
Failure to quarantine unit due to incorrect, incomplete, or positive testing | 51 | 3.5% |
Failure to quarantine unit due to medical history: | 50 | 3.4% |
Post donation illness | 28 | 1.9% |
Failure to quarantine unit due to testing not performed or documented | 39 | 2.7% |
Of the 27,621 reports submitted by licensed blood establishments, 868 (3.1%) reports involved labeling deviations and unexpected events.
Most Frequent BPD Reports - Labeling
From Licensed Blood Establishments
Labeling 868 | # Reports | % of Total |
---|---|---|
Blood unit labels | 504 | 58.1% |
Volume incorrect or missing | 99 | 11.4% |
Extended expiration date or time | 93 | 10.7% |
ABO and / or Rh incorrect | 62 | 7.1% |
Donor number incorrect or missing | 59 | 6.8% |
Crossmatch tag or tie tag labels incorrect or missing information | 409 | 47.1% |
Recipient identification missing or incorrect | 231 | 26.6% |
Autologous unit | 105 | 12.1% |
nit ABO and / or Rh incorrect or missing | 12 | 1.4% |
Crossmatch tag switched, both units intended for the same patient | 12 | 1.4% |
Unit or pool number incorrect or missing | 11 | 1.3% |
Transfusion record (crossmatch slip) incorrect or missing information | 25 | 2.9% |
Recipient identification missing or incorrect | 10 | 1.2% |
Of the 27,621 reports submitted by licensed blood establishments, 798 (2.9%) reports involved blood collection deviations and unexpected events.
Most Frequent BPD Reports - Blood Collection
From Licensed Blood Establishments
Blood Collection 798 | # Reports | % of Total |
---|---|---|
Collection Process | 641 | 80.3% |
Product contained clots, not discovered prior to distribution | 511 | 64.0% |
Product hemolyzed, not discovered prior to distribution | 79 | 9.9% |
Sterility compromised | 103 | 12.9% |
Bacterial contamination | 55 | 6.9% |
Arm prep not performed or performed inappropriately | 24 | 3.0% |
Collection Bag | 28 | 3.5% |
Apheresis collection device | 15 | 1.9% |
Of the 3,502 reports submitted by unlicensed blood establishments, 1,381 (39%) involved quality control and distribution deviations and unexpected events.
Most Frequent BPD Reports - Quality Control & Distribution
From Unlicensed Blood Establishments
QC & Distribution 1,381 | # Reports | % of Total |
---|---|---|
Improper blood bank practices | 997 | 96.9% |
Product not documented as issued in the computer | 237 | 23.0% |
Product not irradiated as required | 184 | 17.9% |
Procedure for issuing not performed or documented in accordance with specifications | 101 | 9.8% |
Improper product selected for patient | 86 | 8.4% |
Improper ABO or Rh type selected for patient | 69 | 6.7% |
Product not leukoreduced as required | 61 | 5.9% |
Unit issued from the blood bank to wrong patient | 55 | 5.3% |
Unit released prior to obtaining current sample for ABO, Rh, antibody screen and / or crossmatch testing | 52 | 5.1% |
Failure to quarantine unit due to testing not performed or documented for: | 184 | 17.9% |
Antigen screen | 50 | 4.9% |
Antibody screen or identification | 34 | 3.3% |
ABO and Rh | 28 | 2.7% |
Inappropriate release of: | 122 | 11.9% |
Product with unacceptable, undocumented, or incomplete product QC | 46 | 4.5% |
Product in which instrument QC or validation unacceptable or not documented | 22 | 2.1% |
Outdated product | 19 | 1.9% |
Failure to quarantine due to incorrect, incomplete, or positive testing: | 44 | 4.3% |
Compatibility | 16 | 1.6% |
Antibody screen or identification | 12 | 1.2% |
Shipping and storage | 40 | 3.9% |
Stored at incorrect temperature | 12 | 1.2% |
Product not packaged in accordance with specifications | 8 | 0.8% |
Of the 3,502 reports submitted by unlicensed blood establishments, 1,062 (30%) involved labeling deviations and unexpected events.
Most Frequent BPD Reports - Labeling
From Unlicensed Blood Establishments
Labeling 1,062 | # Reports | % of Total |
---|---|---|
Crossmatch tag or tie tag labels incorrect or missing information | 517 | 48.7% |
Recipient identification incorrect or missing | 196 | 18.5% |
Crossmatch tag switched, both units intended for the same patient | 90 | 8.5% |
Unit or pool number incorrect or missing | 52 | 4.9% |
Expiration date or time extended or missing | 27 | 2.5% |
Crossmatch tag incorrect or missing | 24 | 2.3% |
Unit ABO and / or Rh incorrect or missing | 24 | 2.3% |
Blood unit labels | 279 | 26.3% |
Extended expiration date or time | 139 | 13.1% |
Donor number incorrect or missing | 37 | 3.5% |
ABO and / or Rh incorrect | 33 | 3.1% |
Product type incorrect | 20 | 1.9% |
Transfusion record (crossmatch slip) incorrect or missing information | 265 | 25.0% |
Recipient identification incorrect or missing | 50 | 4.7% |
Transfusion record switched, both units intended for the same patient | 49 | 4.6% |
Unit or pool number incorrect or missing | 43 | 4.1% |
Of the 3,502 reports submitted by unlicensed blood establishments, 413 (12%) reports involved post donation information.
Most Frequent BPD Reports - Post Donation Information
From Unlicensed Blood Establishments
Post Donation Information 413 | # Reports | % of Total |
---|---|---|
Behavior / History | 324 | 78.5% |
Travel to malaria endemic area / history of malaria | 100 | 24.2% |
Risk factors associated with Creutzfeldt-Jakob Disease (CJD) - travel | 99 | 24.0% |
History of cancer | 15 | 3.6% |
Illness | 71 | 17.2% |
Post donation illness (not hepatitis, HIV, HTLV-I, STD, or cold/flu related) | 43 | 10.4% |
Post donation diagnosis of cancer | 24 | 5.8% |
Testing * | 15 | 3.6% |
* Includes: tested positive for viral marker either prior to or post donation
Of the 3,502 reports submitted by unlicensed blood establishments, 386 (11.0%) reports involved routine testing deviations and unexpected events.
Most Frequent BPD Reports - Routine Testing
From Unlicensed Blood Establishments
Routine Testing 386 | # Reports | % of Total |
---|---|---|
Incorrectly tested for: | 227 | 58.8% |
Compatibility | 88 | 22.8% |
Antibody screening or identification | 63 | 16.3% |
Antigen typing | 20 | 5.2% |
ABO | 12 | 3.1% |
Sample (used for testing) identification | 117 | 30.3% |
Sample used for testing was incorrectly or incompletely labeled | 86 | 22.3% |
Unsuitable sample used for testing (e.g., too old) | 17 | 4.4% |
Incorrect sample tested | 14 | 3.6% |
Reagent QC unacceptable or expired reagents used | 41 | 10.6% |
Multiple testing | 12 | 3.1% |
Antibody screening or identification | 10 | 2.6% |
Antigen typing | 8 | 2.1% |
ABO | 5 | 1.3% |
Of the 1,592 reports submitted by transfusion services, 743 (47%) reports involved quality control and distribution deviations and unexpected events.
Most Frequent BPD Reports - Quality Control & Distribution
From Transfusion Services
QC & Distribution 743 | # Reports | % of Total |
---|---|---|
Distribution procedures not performed in accordance with blood bank transfusion service's specifications | 538 | 72.4% |
Product not documented as issued in the computer | 208 | 28.0% |
Product not irradiated as required | 74 | 10.0% |
Procedure for issuing not performed or documented in accordance with specifications | 54 | 7.3% |
Improper ABO or Rh type selected for patient | 44 | 5.9% |
Improper product selected for patient | 27 | 3.6% |
Unit issued from the blood bank to the wrong patient | 24 | 3.2% |
Product not leukoreduced as required | 23 | 3.1% |
Failure to quarantine unit due to testing not performed or documented for: | 105 | 14.1% |
Antibody screen or identification | 28 | 3.8% |
Antigen screen | 44 | 5.9% |
Crossmatch | 16 | 2.2% |
Inappropriate release of: | 37 | 5.0% |
Outdated product | 15 | 2.0% |
Product with unacceptable, undocumented or incomplete product QC - pH for bacterial detection testing | 10 | 1.4% |
Shipping and storage | 31 | 4.2% |
Temperature not recorded or unacceptable upon receipt, unit redistributed | 9 | 1.2% |
Stored at incorrect temperature | 8 | 1.1% |
No documentation that product was shipped or stored at appropriate temperature | 5 | 0.7% |
Product not packaged in accordance with specifications | 5 | 0.7% |
Failure to quarantine due to incorrect, incomplete, or positive testing: | 32 | 4.3% |
Antibody screen or identification | 11 | 1.5% |
Of the 1,592 reports submitted by transfusion services, 470 (30%) reports involved labeling deviations and unexpected events.
Most Frequent BPD Reports - Labeling
From Transfusion Services
Labeling 470 | # Reports | % of Total |
---|---|---|
Crossmatch tag or tie tag labels incorrect or missing information | 264 | 56.2% |
Recipient identification incorrect or missing | 94 | 20.0% |
Crossmatch tag switched, both units intended for the same patient | 48 | 10.2% |
Unit or pool number incorrect or missing | 50 | 10.6% |
Crossmatch tag incorrect or missing | 18 | 3.8% |
Expiration date or time extended or missing | 13 | 2.8% |
Unit ABO and / or Rh incorrect or missing | 13 | 2.8% |
Transfusion record (crossmatch slip) incorrect or missing information | 123 | 26.2% |
Recipient identification incorrect or missing | 43 | 9.2% |
Unit or pool number incorrect or missing | 16 | 3.4% |
Transfusion record switched, both units intended for the same patient | 13 | 2.8% |
Expiration date or time extended or missing | 12 | 2.6% |
Blood unit labels | 77 | 16.4% |
Expiration date or time extended or missing | 45 | 9.6% |
ABO and / or Rh incorrect | 10 | 2.1% |
Donor number incorrect or missing | 10 | 2.1% |
Of the 1,592 reports submitted by transfusion services, 369 (23%) reports involved routine testing deviations and unexpected events.
Most Frequent BPD Reports - Routine Testing
From Transfusion Services
Routine Testing 369 | # Reports | % of Total |
---|---|---|
Incorrectly tested for: | 204 | 55.3% |
Antibody screening or identification | 76 | 20.6% |
Compatibility | 58 | 15.7% |
Antigen typing | 21 | 5.7% |
Rh typing | 20 | 5.4% |
Sample (used for testing) identification | 128 | 34.7% |
Sample used for testing was incorrectly or incompletely labeled | 97 | 26.3% |
Unsuitable sample used for testing | 15 | 4.2% |
Incorrect sample tested | 14 | 3.8% |
Reagent QC unacceptable or expired reagents used | 37 | 10.0% |
Antibody screening or identification | 10 | 2.7% |
Multiple testing | 8 | 2.2% |
Antigen typing | 6 | 1.6% |
Rh typing | 6 | 1.6% |
Of the 5,115 reports submitted by Source Plasma centers, 4,601 (90%) involved post donation information.
Most Frequent BPD Reports - Post Donation Information
From Plasma Centers
Post Donation Information 4,601 | # Reports | % of Total |
---|---|---|
Behavior / History | 4,304 | 93.5% |
Donor received tattoo within 12 months of donation | 1,593 | 34.6% |
Donor received body piercing within 12 months of donation | 667 | 14.5% |
Incarcerated | 494 | 10.7% |
Risk factors associated with Creutzfeldt-Jakob Disease (CJD) - travel | 268 | 5.8% |
Donor received ear piercing within 12 months of donation | 245 | 5.3% |
Sex partner tested positive for HCV | 178 | 3.9% |
Donor received tattoo and piercing within 12 months of donation | 93 | 2.0% |
IV drug use | 93 | 2.0% |
Testing * | 265 | 5.8% |
Tested positive for HCV post donation | 88 | 1.9% |
Tested positive at another center, specific testing unknown | 71 | 1.5% |
* Includes testing positive for viral marker prior to or post donation
Of the 5,115 reports submitted by Source Plasma centers, 285 (5.6%) reports involved donor screening deviations and unexpected events.
Most Frequent BPD Reports - Donor Screening
From Plasma Centers
Donor Screening 285 | # Reports | % of Total |
---|---|---|
Donor record incomplete, incorrect, or not reviewed | 104 | 36.5% |
Donor history questions | 52 | 18.3% |
Arm inspection | 30 | 10.5% |
Donor signature missing | 15 | 5.3% |
Donor identification | 4 | 1.4% |
Donor gave history which warranted deferral and was not deferred | 134 | 47.0% |
Risk factors associated with Creutzfeldt-Jakob Disease (vCJD) - travel | 30 | 10.5% |
Donor received tattoo within 12 months of donation | 29 | 10.2% |
Donor received vaccine or immune globulin | 13 | 4.6% |
Donor received body piercing within 12 months of donation | 12 | 4.2% |
History of disease or surgery | 11 | 3.9% |
Donor did not meet acceptance criteria | 60 | 21.1% |
Medical review or physical not performed or inadequate | 32 | 11.2% |
Temperature unacceptable or not documented | 17 | 6.0% |
Unexplained weight loss | 4 | 1.4% |
Deferral screening not done | 40 | 14.0% |
Donor previously deferred due to history | 22 | 7.7% |
Deferred by another center | 7 | 2.5% |
Other-unknown | 3 | 1.1% |
Other-Donor unreliable | 2 | 0.7% |
Donor previously deferred due to testing: | 18 | 6.3% |
Elevated for ALT | 10 | 3.5% |
Incorrect ID used during deferral search | 19 | 6.7% |
Donor not previously deferred | 10 | 3.5% |
Donor previously deferred due to history | 7 | 2.5% |
Donor previously deferred due to testing | 2 | 0.7% |
BLOOD AND PLASMA ESTABLISHMENTS
Timeliness Of BPD Reports
Number of Days From Date Discovered To Date FDA Received
Cumulative % of Reports | Licensed BB (Days) | Unlicensed BB (Days) | Transfusion Service (Days) | Plasma Centers (Days) | Total (Days) |
---|---|---|---|---|---|
10% | 12 | 4 | 1 | 14 | 10 |
25% | 20 | 10 | 7 | 26 | 19 |
50% | 27 | 23 | 20 | 36 | 27 |
75% | 33 | 41 | 39 | 44 | 36 |
90% | 44 | 66 | 51 | 54 | 47 |
# Reports | 27,621 | 3,502 | 1,592 | 5,115 | 37,830 |
Range | 0-1325 | 0-711 | 0-433 | 1-1232 | 0-1325 |
Average | 31 | 37 | 27 | 42 | 33 |
# Reports lacking date discovered | 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) | Licensed Establishments | Unlicensed Establishments | Transfusion Services | Plasma Centers | Total | |||||
---|---|---|---|---|---|---|---|---|---|---|
< or = 45 | 25,234 | 91.36% | 2,834 | 80.93% | 1,377 | 86.49% | 4,077 | 79.71% | 35,522 | 88.61% |
Between 45 and 90 | 1,885 | 6.82% | 427 | 12.19% | 164 | 10.30% | 841 | 16.44% | 3,320 | 8.78% |
> 90 | 502 | 1.82% | 241 | 6.88% | 48 | 3.02% | 197 | 3.85% | 988 | 2.61% |
Total | 27,621 | 100% | 3,502 | 100% | 1,592 | 100% | 5,115 | 100% | 37,830 | 100% |
* Reporting time=0 | 49 | 60 | 57 | 0 | 166 |
*Reporting time = 0 - reports were submitted electronically on the day discovered.
The number of reports submitted by non-blood manufacturers was approximately the same as the previous fiscal year.
Total BPD Reports By Manufacturing System
Manufacturing System | Allergenic | Derivative | In-Vitro Diagnostic | Therapeutic | Vaccine | Total | |
---|---|---|---|---|---|---|---|
Incoming Material | 2 | 9 | 5 | 0 | 1 | 17 | 5.1% |
Process Controls | 2 | 9 | 20 | 1 | 7 | 39 | 11.7% |
Testing | 0 | 0 | 14 | 0 | 4 | 18 | 5.4% |
Labeling | 8 | 3 | 16 | 0 | 10 | 37 | 11.1% |
Product Specifications | 146 | 15 | 23 | 0 | 17 | 201 | 60.5% |
Quality Control & Distribution | 0 | 7 | 6 | 1 | 1 | 15 | 4.5% |
Miscellaneous | 0 | 1 | 2 | 2 | 5 | 1.5% | |
Total | 158 | 44 | 86 | 2 | 42 | 332 | 100% |
Potential Recalls By Manufacturing System
Manufacturing System | Allergenic | Derivative | In-Vitro Diagnostic | Therapeutic | Vaccine | Total | |
---|---|---|---|---|---|---|---|
Incoming Material | 0 | 2 | 0 | 0 | 0 | 2 | 11.1% |
Process Controls | 2 | 0 | 1 | 0 | 1 | 4 | 22.2% |
Testing | 0 | 0 | 0 | 0 | 0 | 0 | 0.0% |
Labeling | 3 | 0 | 2 | 0 | 0 | 5 | 27.8% |
Product Specifications | 0 | 1 | 5 | 0 | 0 | 6 | 33.3% |
Quality Control & Distribution | 0 | 0 | 0 | 0 | 0 | 0 | 0.0% |
Miscellaneous | 0 | 1 | 0 | 0 | 0 | 1 | 5.6% |
Total | 5 | 4 | 8 | 0 | 1 | 18 | 100% |
NON-BLOOD MANUFACTURERS
Timeliness Of BPD Reports
Number of Days From Date Discovered To Date FDA Received
Cumulative % of Reports | Allergenic (Days) | Derivative (Days) | In-Vitro Diagnostic (Days) | Therapeutic (Days) | Vaccine (Days) | Total (Days) |
---|---|---|---|---|---|---|
10% | 15 | 16 | 26 | 0 | 18 | 18 |
25% | 22 | 30 | 36 | 0 | 26 | 26 |
50% | 28 | 46 | 43 | 40 | 43 | 40 |
75% | 41 | 91 | 55 | 40 | 52 | 48 |
90% | 61 | 222 | 112 | 40 | 91 | 117 |
# Reports | 158 | 44 | 86 | 2 | 42 | 332 |
Range | 0-603 | 9-710 | 14-2533 | 40-48 | 8-249 | 0-2533 |
Average | 41 | 48 | 85 | 44 | 68 | 53 |
# Reports lacking date discovered | 0 | 0 | 0 | 0 | 2 | 2 |
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 | 127 | 80.4% | 20 | 45.5% | 55 | 64.0% | 1 | 50.0% | 23 | 57.5% | 226 | 68.5% |
> 45 and ≤ 90 | 18 | 11.4% | 12 | 27.3% | 17 | 19.8% | 1 | 50.0% | 12 | 30.0% | 60 | 18.2% |
> 90 | 13 | 8.2% | 12 | 27.3% | 14 | 16.3% | 0 | 0.0% | 5 | 12.5% | 44 | 13.3% |
Total | 158 | 100% | 44 | 100% | 86 | 100% | 2 | 100% | 40 | 100% | 330 | 100% |
Attachments
Attachment 1 - Number of BPD Reports by Type of Blood Establishment (PDF)
Attachment 2 - List of BPD Codes for Blood and Plasma (PDF)
Attachment 3 - Number of BPD Reports by Type of Non-Blood Manufacturer (PDF)
Attachment 4 - List of BPD Codes for Non-Blood Manufacturers (PDF)