Vaccines, Blood & Biologics

Annual Summary for Fiscal Year 2010

 

Biological Product and HCT/P Deviation Report

 

 

Table of Contents

 

  1. Executive Summary:
  2. 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 Licensed Plasma Centers
  3. BPD Reports Submitted by Licensed Manufacturers of Biological Products Other Than Blood and Blood Components (Licensed Non-Blood)
  4. HCT/P Deviation Reports Submitted by Manufacturers of 361 HCT/Ps
  5. Attachments
  6. References

I. Executive Summary:

FDA requires certain deviations and unexpected events in manufacturing to be reported in accordance with 21 CFR 600.14, 606.171 or 1271.350(b). Manufacturers of licensed biological products other than blood and blood components (licensed non-blood) who hold the biological product license for and had control over the product when a deviation or unexpected event occurred are required to submit Biological Product Deviation (BPD) reports (21 CFR 600.14) to the Center for Biologics Evaluation and Research (CBER), if the safety, purity, or potency of a distributed product may be affected. Licensed manufacturers of blood and blood components, including Source Plasma; unlicensed registered blood establishments; and transfusion services who had control over the product when a deviation or unexpected event occurred are also required to submit BPD reports (21 CFR 606.171), if the safety, purity, or potency of a distributed product may be affected. In addition, manufacturers of nonreproductive Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) regulated by FDA solely under section 361 of the Public Health Service Act and 21 CFR Part 1271 are required to submit deviation reports [21 CFR 1271.350(b)] involving distributed products, if the deviation or unexpected event is related to a core Good Tissue Practice requirement [21 CFR 1271.150(b)] and related to the prevention of communicable disease transmission or HCT/P contamination. Detailed information concerning deviation reporting, including guidance documents on BPD reporting for blood and plasma establishments (Ref. 1) and licensed manufacturers of biological products other than blood and blood components (Ref. 2), is available at http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ReportaProblem/BiologicalProductDeviations/default.htm.

The purpose of the annual summary report is to provide detailed information regarding the number and types of deviation reports received during the fiscal year. We compare the number and types of reports received to previous fiscal years and highlight changes in reporting from the previous year.

From October 1, 2009 through September 30, 2010 (FY10), CBER’s Office of Compliance and Biologics Quality/Division of Inspections and Surveillance entered 51,012 deviation reports into the BPD database:

 

  • We received more than 51,012 reports, but this summary does not capture data for reports that did not meet the reporting threshold. We notified the reporter when a report was not required.
  • There was a 2% (730 reports) increase in the number of reports received in FY10 compared to FY09 {Table 2}
    • We received 2% more reports from blood and plasma establishments in FY10 compared to FY09 {Table 2}
      • We received 3% fewer reports from licensed blood establishments in FY10 compared to FY09 {Table 2}
      • We received 2% fewer reports from unlicensed registered blood establishments in FY10 compared to FY09 {Table 2}
      • We received 9% fewer reports from transfusion services in FY10 compared to FY09 {Table 2}
      • We received 11% more reports from licensed plasma centers in FY10 compared to FY09 {Table 2}
    • We received 30% more reports from manufacturers of licensed biological products other than blood and blood components in FY10 compared to FY09 {Table 2}
      • Vaccine manufacturers submitted 74 more reports in FY10
      • Blood Derivative manufacturers submitted 35 more reports in FY10
      • In-vitro diagnostic manufacturers submitted 34 more reports in FY10
      • Allergenic manufacturers submitted five more reports in FY10
      • Licensed HCT/P manufacturers (351 HCT/P) submitted four more reports in FY10
    • We received 32 more reports from 361 HCT/P manufacturers in FY10 compared to FY09 {Table 2}
      • Cellular HCT/P manufacturers submitted 29 more reports in FY10
      • Non-cellular HCT/P manufacturers submitted three more reports in FY1

 

  • The number of reporting establishments increased by four in FY10 compared to FY09 {Table 2}

 

    • Compared to FY09, there were 12 more unlicensed blood establishments, 30 fewer transfusion services and 18 more licensed plasma centers reporting in FY10
    • Compared to FY09, there were 6 more manufacturers of licensed biological products other than blood and blood components reporting in FY10
    • Compared to FY09, there 5 fewer 361 HCT/P manufacturers reporting in FY10

 

You may submit questions concerning this summary 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@fda.hhs.gov, hctp_deviations@fda.hhs.gov, or sharon.ocallaghan@fda.hhs.gov (Sharon O’Callaghan) or by phone at 301-827-6220.

Total Deviation Reports FY10

Table 1

 

 Number Of Reporting EstablishmentsTotal Reports ReceivedPotential Recalls
Blood/Plasma Manufacturers
Licensed Blood Establishments250(113*)24,2828383.5%
Unlicensed Blood Establishments 14253,850270.7%
Transfusion Services 25451,76000.0%
Licensed Plasma Centers392(48*)20,1732911.4%
Sub-Total 1,611 50,065 1,156 2.3%
Licensed Non-Blood Manufacturers
Allergenic719742.0%
Blood Derivative239900.0%
In Vitro Diagnostic141171210.2%
Vaccine1724283.3%
351 HCT/P2600.0%
Sub-Total 63 661 24 3.6%
361 HCT/P Manufacturers
Cellular HCT/P4316010.6%
Non-Cellular HCT/P321262822.2%
Sub-Total 75 286 29 10.1%
Total1,749 51,012 1,209 2.4%

 

1 Unlicensed Blood Establishments – unlicensed blood establishments performing manufacturing of blood and blood components require registration with FDA

2 Transfusion Services – blood banks that perform limited blood and blood component manufacturing (e.g. pooling, thawing, compatibility testing), may or may not register with FDA.

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

Total Deviation Reports FY08 – FY10

Table 2

 Number Of Reporting EstablishmentsTotal Reports ReceivedPotential
Blood/Plasma ManufacturersFY08FY09FY10 FY08 FY09 FY10 FY08 FY09 FY10
Licensed Blood Establishments247(120*)246( 113*)250(113*)26,65525,48124,2821,9281,189838
Unlicensed Blood Establishments4174134253,7983,9403,850333927
Transfusion Services5415755451,8581,9321,760000
Licensed Plasma Centers328( 43*)374( 53*)392(48*)11,81418,16820,173438450291
Sub-Total 1,544 1,609 1,611 44,125 49,521 50,065 2,399 1,678 1,156
Licensed Non-Blood Manufacturers         
Allergenic787169192197204
Blood Derivative171923496499700
In Vitro Diagnostic8111477831177112
Vaccine15181798168242138
351 HCT/P012026000
Sub-Total47 57 63 393 509661 174 24
361 HCT/P Manufacturers         
Cellular HCT/P484043140131160211
Non-Cellular HCT/P36403282123126383228
Sub-Total 84 80 75 222 254 286 40 33 29
Total1,6751,7451,749 44,740 50,282 51,012 2,456 1,715 1,209

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

Blood & Plasma BPD Reports By Manufacturing System FY08 – FY10

Table 3

Manufacturing SystemFY08FY09FY10
Donor Suitability32,57973.8%37,62076.0%39,26778.4%
Post Donation Information 30,152 68.3% 34,844 70.4% 36,267 72.4%
Donor Screening 2,290 5.2% 2,726 5.5% 2,758 5.5%
Donor Deferral 137 0.3% 50 0.1% 197 0.4%
QC & Distribution4,93711.2%4,8379.8%4,2898.6%
Labeling2,2885.2%2,2614.6%2,1184.2%
Miscellaneous1,9144.3%2,2614.6%2,0744.1%
Laboratory Testing1,1482.6%1,042.1%1,0192.0%
Routine Testing 1,104 2.5% 998 2.0% 1,007 2.0%
Viral Testing 44 0.1% 42 0.1% 12 0.0%
Collection7761.8%9962.0%1,0192.0%
Component Preparation4831.1%5061.0%3240.6%
Total44,125100% 49,521 100% 50,065 100%

 

Licensed Non-Blood Deviation Reports By Manufacturing System FY08 – FY10

Table 4

Manufacturing SystemAllergenicBlood DerivativeIn Vitro Diagnostic
 FY08 FY09 FY10 FY08 FY09 FY10 FY08 FY09 FY10
Product Specifications161181179183525283852
Quality Control & Distribution022549141131
Process Controls44988359146
Labeling44742418814
Incoming Material0103715244
Testing000889779
Miscellaneous000302011
Total169 192 197 49 64 99 78 83 117

 

Table 4 (continued)

 

Manufacturing SystemVaccine351 HCT/PTotal
 FY08 FY09 FY10 FY08 FY09 FY10 FY08 FY09 FY10
Product Specifications504391002257297349
Quality Control & Distribution20849300139101136
Process Controls91013010303763
Labeling71916001333342
Incoming Material151100261732
Testing7414010222032
Miscellaneous334000647
Total97168242026393509661

 

361 HCT/P Deviation Reports By Manufacturing System FY08 – FY10

 Table 5

 

Manufacturing SystemCellular HCT/PsNon-Cellular HCT/PsTotal
 FY08 FY09 FY10 FY08 FY09 FY10 FY08 FY09 FY10
Donor Testing42427123456543883
Processing & Processing Controls5066641835176810181
Receipt, Pre-Distrib., Shipment & Distrib.335353354365857
Donor Eligibility423333223363426
Donor Screening2011572017721
Recovery8690808149
Supplies and Reagents100004104
Environmental Control001001002
Labeling Controls001221222
Storage001000001
Total140131 160 83 123 126 222254 286

 

Back to the Top


 

II. BPD Reports Submitted By Blood and Plasma Establishments:

 

  • Blood and plasma establishments submitted 544 more reports in FY10 than in the previous fiscal year (FY09-49,521) {Table 2}.
  • Licensed blood establishments submitted 1,199 fewer reports (FY09-25,481)
    • The number of reports involving post donation information decreased by 4% (FY09-18,558, FY10-17,807). Most frequently, these events related to donors who traveled to risk areas (FY09-10,158, FY10-9,647).
    • The number of reports involving component preparation decreased by 43% (FY09-420, FY10-238). The number of reports involving products not prepared in accordance with specifications decreased from 318 in FY09 to 186 in FY10.
      • The number of reports in which the irradiation process was not performed in accordance with specifications decreased from 114 in FY09 to 51 in FY10
    • The number of reports involving labeling decreased by 18% (FY09-749, FY10-615). The number of reports involving incorrect or missing information on the product label decreased from 408 in FY09 to 300 in FY10.
      • The number of reports in which the product or anticoagulant volume or weight was incorrect or missing decreased from 92 in FY09 to 64 in FY10
      • The number of reports in which the product type or code was incorrect or missing decreased from 56 in FY09 to 34 in FY10
      • The number of reports in which the donor/unit number was incorrect or missing decreased from 61 in FY09 to 43 in FY10
    • The number of reports involving quality control and distribution decreased by 15% (FY09-1,662, FY10-1,421). Most frequently, these events related to bacterial detection testing (FY09-410, FY10-319).
  • Unlicensed registered blood establishments submitted 90 fewer reports (FY09-3,940)
    • The number of reports involving quality control and distribution decreased by 8% (FY09-1,916, FY10-1,764)
      • The number of reports involving distribution procedures not performed in accordance with the blood bank transfusion service’s specifications decreased from 1,406 in FY09 to 1,349 in FY10
      • The number of reports involving testing not performed, incompletely performed or not documented decreased from 298 in FY09 to 246 in FY10
  • Transfusion services submitted 172 fewer reports (FY09-1,932)
    • Unregistered transfusion services typically report few BPDs (67% of those reporting in FY10 submitted 1 or 2 reports) and may file no reports in a given year. Only 17% of the transfusion services submitted more than five reports during FY10
    • The distribution of reports submitted in FY10 by transfusion services was similar to FY09
      • 986 (56%) reports involved quality control and distribution (FY09-1,070{55%})
      • 466 (26%) reports involved labeling (FY09-534 {28%})
      • 304 (17%) reports involved routine testing (FY09-322 {17%})
  • Licensed plasma centers submitted 2,005 more reports (FY09-18,168)
    • The number of reports involving post donation information increased by 14% (FY09-15,871, FY10-18,038), specifically involving donors who had a history of tattoo and/or piercing (FY09-11,731, FY10-13,155) or a history of incarceration (FY09-1,008, FY10-1,126)
    • The number of reports involving products that were collected and distributed from a donor who subsequently tested confirmed positive for a viral marker was the same as the previous fiscal year (FY09-1,363, FY10-1,362)
    • The number of reports involving donor screening decreased from 715 in FY09 to 622 in FY10
      • The number of reports involving donor record incomplete or incorrect decreased from 227 in FY09 to 191 in FY10
      • The number of reports involving the donor not meeting the acceptance criteria decreased from 200 in FY09 to 169 in FY10

Total BPDRs By Manufacturing System Blood and Plasma Establishments

Table 6

 

Manufacturing SystemLicensed Blood EstablishmentsUnlicensed Blood EstablishmentsTransfusion ServicesLicensed Plasma CentersTotal
DS-Post Donation Information17,807422NA18,03836,26772.4%
QC & Distribution1,4211,7649861184,2898.6%
DS-Donor Screening2,05284NA6222,7585.5%
Labeling6151,022466152,1184.2%
Miscellaneous69121NA1,3622,0744.1%
Blood Collection97140NA81,0192.0%
LT-Routine Testing29341030401,0072.0%
Component Preparation23880423240.7%
DS-Donor Deferral1836NA81970.4%
LT-Viral Testing111NA0120.0%
Total24,2823,8501,76020,17350,065100%

 

DS-Donor Suitability
LT-Laboratory Testing
NA-Not applicable : manufacturing not performed in transfusion service

Post Donation Information

Post donation information (PDI) continues to be the most frequently reported event associated with the manufacturing of blood and plasma products (72% of deviation reports) {Table 6}. The number of reports blood and plasma establishments submitted involving post donation information increased by 4% from the previous fiscal year (FY09-34,843, FY10-36,267

  •  Licensed plasma centers submitted 2,167 more reports in FY10 compared to FY09 involving post donation information. Most of these reports involved donors who had a history of tattoo and/or piercing or a history of incarceration.
  • Blood establishments submitted 743 fewer reports in FY10 compared to FY09 involving post donation information. They submitted 488 fewer reports involving travel to malarial endemic areas or variant Creutzfeldt-Jakob Disease (vCJD) risk areas.

Table 7 illustrates the major differences in post donation information reports from FY09 to FY10. It does not include all post donation information reports.

PDI Reports Submitted by Blood and Plasma Establishments

Table 7

 

Blood EstablishmentsFY08FY09FY10
Post Donation Information (PD) - total20,04518,97218,229
Donor had a history of travel to malarial risk area7,2166,6546,553
Donor had a history of travel to vCJD risk area3,8713,6833,296
Donor received tattoo and/or piercing1,2901,4311,466
Post donation illness1,2131,029967
Donor had male/male sex833868810

 

 

Licensed Plasma CentersFY08FY09FY10
Post Donation Information (PD) - total10,10715,87118,038
Donor received tattoo and/or piercing7,24011,73113,155
Donor had a history of incarceration6851,0081,126

 

Miscellaneous

The number of reports blood and plasma establishments submitted in which they distributed a unit collected from a donor who subsequently tested confirmed positive for a viral marker (on a later donation) decreased by 8% from the previous fiscal year (FY09-2,237, FY10-2,049).

 

  • The number of these reports submitted by blood establishments decreased by 21% (FY09-874, FY10-687)
  • The number of these reports submitted by licensed plasma establishments was the same as the previous fiscal year (FY09-1,363, FY10-1,362)

 

Table 8 illustrates the number of reports related to units collected from donors who subsequently tested confirmed positive for selected viral markers (lookback).

Viral Maker Lookback Reports Submitted by Blood and Plasma Establishments

Table 8

 

Blood EstablishmentsFY06FY07FY08FY09FY10
Lookback; Subsequent unit confirmed positive (MI02) - total510721852874687
HCV (MI0204)309315405527377
HIV (MI0202)88120152133167
HBV (MI0203)9616314012793

 

 

 

Licensed Plasma CentersFY06FY07FY08FY09FY10
Lookback; Subsequent unit confirmed positive (MI02) - total986461,0381,3631,362
HCV (MI0204)63393579814725

HBV (MI0203)

23171324401461
HIV (MI0202)1381129146172

 

A. Most Frequent BPD Reports Submitted by Licensed Blood Establishments

Of the 24,282 reports submitted by licensed blood establishments, 17,807 (73.3%) reports involved post donation information.

 

  • The number of these reports decreased by 4% (FY09-18,558)
  • The number of reports in which a donor or third party provided subsequent information related to high risk behavior or history decreased by 5% (FY09-17,303)
    • The number of reports in which a donor or third party provided subsequent information regarding travel to a malaria risk area decreased by 2% (FY09-6,521)
    • The number of reports in which a donor or third party provided subsequent information regarding travel to a vCJD risk area decreased by 1% (FY09-3,594)

 

Most Frequent BPD Reports - Post Donation Information From Licensed Blood Establishments

Table 9

 

POST DONATION INFORMATION (PD) 17,807# Reports% of Total (PD)
Behavior/History 16,437 92.3%
Travel to malaria endemic area/history of malaria6,38935.9%
Risk factors associated with Creutzfeldt-Jakob Disease (CJD) – travel3,2088.0%
Donor received tattoo and/or piercing1,4448.1%
Male donor had sex with another man7944.5%
Received finasteride (Proscar/Propecia), Tegison, Accutane, or Avodart6143.4%
Donor received tissue allograft or transplanted organ4642.6%
IV drug use4162.3%
Illness1,008 5.7%
Post donation illness (not hepatitis, HIV, HTLV-I, STD, cancer or cold/flu related)9485.3%
Post donation diagnosis or symptoms of Hepatitis C150.1%
Post donation diagnosis or symptoms of HIV130.1%
Testing * 299 1.7%
Tested reactive for HIV prior to donation680.4%
Tested reactive for Hepatitis B prior to donation540.3%
Tested reactive for Hepatitis C prior to donation510.3%
Tested reactive for HIV post donation270.2%
Tested reactive for HTLV prior to donation250.1%
Not specifically related to high risk behavior 630.4%
Donated to be tested or called back for test results370.2%
Donor does not want their blood used260.1%

 

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

Of the 24,282 reports submitted by licensed blood establishments, 2,052 (8.5%) reports involved donor screening deviations or unexpected events.

 

  • The number of these reports increased by 7% (FY09-1,914)
  • The number of reports in which the incorrect identification was used during the deferral search increased by 40% (FY09-918)
  • The number of reports in which the donor gave history which warranted deferral or follow up and was not deferred decreased by 24% (FY09-496)
  • The number of reports related to the donor providing a history of travel to a malaria risk or vCJD risk area decreased from 355 in FY09 to 279 in FY10
  • The number of reports in which the donor record was incomplete or incorrect increased by 22% (FY09-274)
  • The number of reports related to donor history questions decreased from 314 in FY09 to 281 in FY10

 

Most Frequent BPD Reports – Donor Screening From Licensed Blood Establishments

Table 10

 

DONOR SCREENING (DS) 2,052# Reports% of Total (DS)
Incorrect ID used during deferral search 1,28362.5%
Donor not previously deferred1,22159.5%
Donor previously deferred due to history422.0%
Donor previously deferred due to testing201.0%
Donor gave history which warranted deferral or follow up and was not deferred 375 18.3%
Travel to malaria endemic area/history of malaria21510.5%
Risk factors associated with Creutzfeldt-Jakob Disease (vCJD) - travel643.1%
Received medication or antibiotics170.8%
Donor record incomplete or incorrect 333 16.2%
Donor history questions28113.7%
Incorrect gender specific question asked1748.5%
Donor identification291.4%
Donor signature missing70.3%
Donor did not meet acceptance criteria 351.7%
Hemoglobin or Hematocrit unacceptable or not documented or testing was performed incorrectly180.9%
Temperature unacceptable or not documented70.3%
Deferral screening not done or incorrectly performed 25 1.2%
Donor previously deferred due to history180.9%
Donor previously deferred due to testing70.3%

 

Of the 24,282 reports submitted by licensed blood establishments, 1,421 (5.9%) reports involved quality control and distribution deviations or unexpected events.

 

  • The number of these reports decreased by 15% (FY09-1,662)
  • The number of reports involving the distribution of product that did not meet specifications decreased by 18% (FY09-1,240)
    • The number of reports involving the release of a product with unacceptable, undocumented, or incomplete product QC decreased by 16% (FY09-725). Most frequently these events related to bacterial detection testing, which decreased by 16% (FY09-410).
    • The number of reports involving the release of a product in which instrument QC or validation was unacceptable, incomplete, not performed or documented decreased from 169 in FY09 to 94 in FY10

 

Most Frequent BPD Reports –Quality Control & Distribution From Licensed Blood Establishments

Table 11

 

QC & DISTRIBUTION (QC) 1,421# Reports% of Total (QC)
Distribution of product that did not meet specifications 1,013 71.3%
Product QC unacceptable, not performed, not documented, or incomplete60942.9%
Bacterial detection testing31922.4%
Platelet count1319.2%
White Blood Cell count594.2%
Product in which instrument QC or validation was unacceptable, incomplete, not performed or documented946.6%
Product identified as unsuitable due to a collection deviation or unexpected event815.7%
Other - Product distributed prior to required record review785.5%
Product identified as unsuitable due to a donor screening deviation or unexpected event312.2%
Shipping and storage 212 14.9%
No documentation that product was shipped or stored at appropriate temperature574.0%
Product not packaged in accordance with specifications or no documentation that product was packed appropriately523.7%
Product arrived at consignee at unacceptable temperature312.2%
Distribution procedures not performed in accordance with blood bank transfusion service’s specifications 91 6.4%
Product not documented or incorrectly documented as issued in the computer191.3%
Product not irradiated as required141.0%
Product not leukoreduced as required130.9%
Testing not performed, incompletely performed, or not documented 56 3.9%
Antigen screen100.7%
Antibody screen or identification90.6%
Failure to quarantine unit due to medical history: 282.0%
Post donation illness171.2%
Positive testing 21 1.0%

 

Of the 24,282 reports submitted by licensed blood establishments, 971 (4.0%) reports involved blood collection deviations or unexpected events.

 

  • There were 42 more reports involving blood collection events than in FY09 (929)
      • The number of reports involving the collection process increased by 74 reports (FY09 – 814)
    • The number of reports of clotted units increased by 24% (FY09 – 599)
    • There were 27 fewer reports of hemolyzed units in FY09 (79)
    • There were 26 fewer reports associated with the apheresis collection process in FY09 (69)
      • The number of reports involving the collection bag decreased from 31 in FY09 to 18 in FY10

 

Most Frequent BPD Reports – Blood Collection From Licensed Blood Establishments

Table 12

 

 

BLOOD COLLECTION (BC) 971#Reports% of Total (BC)
Collection process 888 91.5%
Product contained clots, not discovered prior to distribution74176.3%
Apheresis collection process525.4%
Product hemolyzed, not discovered prior to distribution434.4%
Sterility compromised 62 6.4%
Arm prep not performed or performed inappropriately232.4%
Air contamination222.3%
Bacterial contamination171.8%
Collection bag 18 1.9%
Potential collection set defect151.5%
Blood drawn into outdated bag30.3%

 

Of the 24,282 reports submitted by licensed blood establishments, 691 (2.8%) reports involved miscellaneous deviations or unexpected events.

 

      • The number of these reports decreased by 22% (FY09-884)
      • The number of reports in which products were collected and distributed from a donor who subsequently tested confirmed positive decreased by 23% (FY09-860)
  • The number of reports in which a donor subsequently tested confirmed positive for HCV decreased by 29% (FY09-521)
  • The number of reports in which a donor subsequently tested confirmed positive HBV decreased from 170 in FY09 to 88 in FY10
  • The number of reports in which a donor subsequently tested confirmed positive for HIV increased from 132 in FY09 to 163 in FY10
  • The number of reports in which a donor subsequently tested confirmed positive for Chagas decreased by 52% (FY09-48)
  • The number of reports in which a donor was either implicated in or not ruled out of a transfusion associated disease was similar to the previous fiscal year (FY09-24, 17 reports of Babesia)

 

Most Frequent BPD Reports - Miscellaneous From Licensed Blood Establishments

Table 13

 

MISCELLANEOUS (MI) 691# Reports% of Total (MI)
Lookback; subsequent unit tested confirmed positive for: 666 96.4%
HCV36953.4%
HIV16323.6%
HBV689.8%
2x Anti-HBc positive202.9%
Chagas233.3%
HTLV131.9%
West Nile Virus50.7%
Donor implicated in transfusion associated disease 25 3.6%
Babesia142.0%

 

B. Most Frequent BPD Reports Submitted by Unlicensed Registered Blood Establishments

Of the 3,850 reports submitted by unlicensed registered blood establishments, 1,764 (45.8%) involved quality control and distribution deviations or unexpected events.

 

  • The number of these reports decreased by 8% (FY09-1,916)
  • The number of reports involving distribution procedures not performed in accordance with the blood bank transfusion service’s specifications decreased by 4% (FY09-1,406)
    • The number of reports involving the release of a product that was not documented or incorrectly documented as issued in the computer, which was the only method of documenting the visual and clerical checks at the time of distribution, decreased by 8% (FY09-664)
    • There were 38 fewer reports involving the release of a product that was not irradiated as required (FY09-228)

 

Most Frequent BPD Reports - Quality Control & Distribution From Unlicensed Registered Blood Establishments

Table 14

 

QC & DISTRIBUTION (QC) 1,764# Reports% of Total (QC)
Distribution procedures not performed in accordance with blood bank transfusion service’s specifications 1,349 76.5%
Product not documented or incorrectly documented as issued in the computer61334.8%
Product not irradiated as required19010.8%
Improper product selected for patient1247.0%
Procedure for issuing not performed or documented in accordance with specifications784.4%
Product issued to wrong patient683.9%
Improper ABO or Rh type selected for patient663.7%
Testing not performed, incompletely performed, or not documented 246 13.9%
Antibody screen or identification663.7%
ABO and/or Rh533.0%
Compatibility533.0%
Antigen screen533.0%
Distribution of product that did not meet specifications: 135 7.7%
Product QC unacceptable, not performed, not documented or incomplete623.5%
Bacterial detection testing372.1%
Product in which instrument QC or validation unacceptable, incomplete or not documented382.2%
Outdated product160.9%
Shipping and storage 28 1.6%
Stored at incorrect temperature70.4%
No documentation that product was shipped or stored at appropriate temperature70.4%
Temperature not recorded or unacceptable upon return, unit redistributed70.4%

 

Of the 3,850 reports submitted by unlicensed registered blood establishments, 1,022 (26.5%) involved labeling deviations or unexpected events.

 

  • The number of these reports increased by 5% (FY09-970)
  • The number of reports involving crossmatch tag or tie tag labeled with incorrect or missing information was similar to the reports received in the previous fiscal year (FY09-550)
  • There were 31 more reports involving the unit labeled with incorrect or missing information than in the previous fiscal year (FY09-251)
  • There were 24 more reports involving the transfusion record labeled with incorrect or missing information than in the previous fiscal year (FY09-169)

 

Most Frequent BPD Reports - Labeling From Unlicensed Registered Blood Establishments

Table 15

 

LABELING (LA) 1,022#Reports% of Total (LA)
Crossmatch tag or tie tag labels incorrect or missing information 547 53.5%
Crossmatch tag switched, both units intended for the same patient14814.5%
Recipient identification incorrect or missing13613.3%
Unit, lot, or pool number incorrect or missing929.0%
Labels applied to blood unit or product incorrect or missing information 282 27.6%
Extended expiration date or time12912.6%
Product type or code incorrect or missing333.2%
ABO and/or Rh incorrect or missing313.0%
Donor/unit number or lot number incorrect or missing232.3%
Transfusion record (crossmatch slip) incorrect or missing information 193 18.9%
Transfusion record switched, both units intended for the same patient605.9%
Unit, lot, or pool number incorrect or missing373.6%
Recipient identification incorrect or missing292.8%

 

Of the 3,850 reports submitted by unlicensed registered blood establishments, 422 (11%) reports involved post donation information.

 

  • The number of these reports was similar to the reports received in the previous fiscal year (FY09-414)
  • The number of reports in which a donor or third party provided subsequent information related to high risk behavior or history was the same as the reports received in the previous fiscal year (FY09-389)
    • The number of reports in which a donor or third party provided subsequent information regarding travel to a malarial risk area increased from 133 in FY09 to 164 in FY10
    • The number of reports in which a donor or third party provided subsequent information regarding travel to a vCJD risk area was similar to the previous fiscal year (FY09-89)
  • The number of reports in which a donor or third party provided subsequent information related to post donation illness increased from 17 in FY09 to 22 in FY10

 

Most Frequent BPD Reports - Post Donation Information From Unlicensed Registered Blood Establishments

Table 16

 

POST DONATION INFORMATION (PD) 422# Reports% of Total (PD)
Behavior/History 389 92.2%
Travel to malaria endemic area/history of malaria16438.9%
Risk factors associated with Creutzfeldt-Jakob Disease (vCJD) – travel8820.9%
Donor received tattoo and/or piercing307.1%
Illness 22 5.2%
Testing* 10 2.4%

 

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

Of the 3,850 reports submitted by unlicensed registered blood establishments, 410 (10.6%) reports involved routine testing deviations or unexpected events.

 

  • The number of these reports was similar to the reports received in the previous fiscal year (FY09-387)
  • The number of reports involving testing that was performed, interpreted or documented incorrectly increased by 19% (FY09-199)
  • The number of reports involving sample identification decreased from 125 in FY09 to 109 in FY10
  • The number of reports involving unacceptable reagent QC or the use of expired reagents was similar to the reports received in the previous fiscal year (FY09-63)

 

Most Frequent BPD Reports - Routine Testing From Unlicensed Registered Blood Establishments

Table 17

 

ROUTINE TESTING (RT) 410# Reports% of Total (RT)
Testing performed, interpreted, or documented incorrectly 237 57.8%
Compatibility7919.7%
Antibody screening or identification6916.8%
Antigen typing399.5%
ABO and/or Rh338.0%
Sample (used for testing) identification 109 26.6%
Sample used for testing was incorrectly or incompletely labeled8520.7%
Unsuitable sample used for testing (e.g., too old)163.9%
Incorrect sample tested82.0%
Reagent QC unacceptable or expired reagents used 64 15.6%
Antigen typing194.6%
Antibody screening or identification153.7%
Multiple testing71.7%

 

C. Most Frequent BPD Reports Submitted by Transfusion Services

Of the 1,760 reports submitted by transfusion services, 986 (56%) reports involved quality control and distribution deviations or unexpected events.

 

  • The number of these reports decreased by 8% (FY09-1,070)
  • The number of reports involving the release of a product that was not documented or incorrectly documented as issued in the computer, which was the only method of documenting the visual and clerical checks at the time of distribution, increased from 328 in FY09 to 336 in FY10
  • The number of reports involving testing not performed, incompletely performed or not documented decreased by 13% (FY09-256)

 

Most Frequent BPD Reports - Quality Control & Distribution From Transfusion Services

Table 18

 

QC & DISTRIBUTION (QC) 986# Reports% of Total (QC)
>Distribution procedures not performed in accordance with blood bank transfusion service’s specifications 701 71.1%
Product not documented or incorrectly documented as issued in the computer33634.1%
Product not irradiated as required656.6%
Improper ABO or Rh type selected for patient515.2%
Procedure for issuing not performed or documented in accordance with specifications454.6%
Improper product selected for patient434.4%
Product released prior to obtaining current sample for ABO, Rh, antibody screen and/or compatibility testing414.2%
Product issued to the wrong patient292.9%
Product not leukoreduced as required161.6%
Testing not performed, incompletely performed, or not documented 224 22.7%
Antibody screen or identification717.2%
Antigen screen596.0%
ABO and/or Rh495.0%
Distribution of product that did not meet specifications: 36 3.7%
Outdated product232.3%
Product QC unacceptable, not performed, not documented or incomplete70.7%
Shipping and storage 25 2.5%
Stored at incorrect temperature101.0%
No documentation that product was shipped or stored at appropriate temperature50.5%
Product not packed in accordance with specifications or no documentation that product was packed in appropriately40.4%

 

Of the 1,760 reports submitted by transfusion services, 466 (26.5%) reports involved labeling deviations or unexpected events.

 

  • The number of these reports decreased by 13% (FY09-534)
  • The number of reports involving the labeling of the crossmatch or tie tag decreased by 17% (FY09-326)
  • The number of reports involving the labeling of the transfusion record was similar to the reports received in the previous fiscal year (FY09-157)
  • The number of reports involving the labeling of the product was similar to the reports received in the previous fiscal year (FY09-51)

 

Most Frequent BPD Reports - Labeling From Transfusion Services

Table 19

 

LABELING (LA) 466# Reports% of Total (LA
Crossmatch tag or tie tag labels incorrect or missing information 269 57.7%
Recipient identification incorrect or missing7315.7%
Crossmatch tag switched, both units intended for the same patient5712.2%
Unit, lot, or pool number incorrect or missing459.7%
Crossmatch tag or tie tag missing or attached to incorrect unit265.6%
Expiration date or time extended or missing173.6%
Transfusion record (crossmatch slip) incorrect or missing information 150 32.2%
Recipient identification incorrect or missing449.4%
Transfusion records switched, both units intended for the same patient255.4%
Unit, lot, or pool number incorrect or missing255.4%
Expiration date or time extended or missing91.9%
Labels applied to blood unit or product incorrect or missing information 47 10.1%
Extended expiration date or time255.4%
Donor number or lot number incorrect or missing71.5%
Product type/code and expiration date incorrect or missing40.9%
ABO and/or Rh incorrect or missing40.9%

 

Of the 1,760 reports submitted by transfusion services, 304 (17.3%) reports involved routine testing deviations or unexpected events.

 

  • The number and distribution of these reports was similar to the reports received in the previous fiscal year (FY09-322)
  • The number of reports involving testing that was performed, interpreted or documented incorrectly increased from 179 in FY09 to 181 in FY10
  • The number of reports involving sample identification decreased from 81 in FY09 to 70 in FY10
  • The number of reports involving unacceptable reagent QC or the use of expired reagents decreased from 62 in FY09 to 53 in FY10

 

Most Frequent BPD Reports - Routine Testing From Transfusion Services

Table 20

 

ROUTINE TESTING (RT) 304# Reports% of Total (RT)
Testing performed, interpreted, or documented incorrectly 181 59.5%
Compatibility5819.1%
Antibody screening or identification5718.8%
Antigen typing309.9%
ABO and/or Rh typing268.6%
Sample (used for testing) identification 70 23.0%
Sample used for testing was incorrectly or incompletely labeled5417.8%
Unsuitable sample used for testing93.0%
Incorrect sample tested72.3%
Reagent QCunacceptable or expired reagents used 53 17.4%
Antibody screening or identification185.9%
Multiple testing144.6%
Antigen typing103.3%

 

D. Most Frequent BPD Reports Submitted by Licensed Plasma Centers

Of the 20,173 reports submitted by licensed plasma centers, 18,038 (89.4%) involved post donation information.

 

  • The number of these reports increased by 14% (FY09-15,871)
  • The number of reports in which a donor or third party provided subsequent information related to high risk behavior or history increased by 14% (FY09-15,454)
    • The number of post donation information reports in which the donor had a history of a tattoo and/or piercing increased by 12% (FY09-11,731)
    • The number of post donation information reports in which the donor had a history of incarceration increased 12% (FY09-1,008)
  • The number of reports in which a donor or third party provided subsequent information related to testing decreased by 9% (FY09-411)
    • The number of reports in which the donor tested positive, specific testing unknown, by another facility decreased by 12% (FY09-300)

 

Most Frequent BPD Reports - Post Donation Information From Licensed Plasma Centers

Table 21

 

POST DONATION INFORMATION (PD) 18,038# Reports% of Total (PD)
Behavior/History 17,653 97.9%
Donor received tattoo and/or piercing13,15572.9%
Incarcerated1,1266.2%
Other; unacceptable address, donor unreliable3952.2%
Non-sexual exposure to Hepatitis C3321.8%
Risk factors associated with Creutzfeldt-Jakob Disease (vCJD) – trave3321.8%
IV drug use3181.8%
Testing * 372 2.1%
Tested reactive at another center, specific testing unknown2641.5%
Tested reactive for HCV post donation400.2%
Tested reactive for HIV post donation310.2%
Tested reactive for HBV post donation200.1%
Illness 12 0.1%

 

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

Of the 20,173 reports submitted by licensed plasma centers, 1,362 (6.8%) reports involved miscellaneous deviations or unexpected events.

 

  • The number of these reports was similar to the reports received in the previous fiscal year (FY09-1,363)
  • The number of reports in which products were collected and distributed from a donor who subsequently tested confirmed positive for HCV decreased by 11% (FY09-814)
  • The number of reports in which products were collected and distributed from a donor who subsequently tested confirmed positive for HBV increased 15% (FY09-401)
  • The number of reports in which products were collected and distributed from a donor who subsequently tested confirmed positive for HIV increased 18% (FY09-146)

 

Most Frequent BPD Reports - Miscellaneous From Licensed Plasma Centers

Table 22

 

MISCELLANEOUS (MI) 1,362# Reports% of Total (MI
Lookback; subsequent unit tested confirmed positive for: 1,362 100.0%
HCV72553.2%
HBV46133.8%
HIV17212.6%

 

Of the 20,173 reports submitted by licensed plasma centers, 622 (3.1%) reports involved donor screening deviations or unexpected events.

 

  • The number of these reports decreased by 13% (FY09-715)
  • The number of reports in which the donor record was incomplete or incorrect decreased from 227 in FY09 to 191 in FY10
  • The number of reports in which the donor gave history which warranted deferral or follow up and was not deferred decreased from 209 in FY09 to 192 in FY10
    • The majority of these events involved donors who had a history of a tattoo and/or piercing (FY09-134, FY10-135)
  • The number of reports in which the donor did not meet acceptance criteria decreased from 200 in FY09 to 169 in FY10
    • The number report in which the donor did not meet acceptance criteria due to unacceptable address or no proof of address decreased from 58 in FY09 to 30 in FY10

 

Most Frequent BPD Reports - Donor Screening From Licensed Plasma Centers

Table 23

 

DONOR SCREENING (DS) 622# Reports% of Total (DS)
Donor gave history which warranted deferral or follow up and was not deferred 192 30.9%
Donor received tattoo and/or piercing13521.7%
Risk factors associated with Creutzfeldt-Jakob Disease (vCJD) - travel111.8%
Donor had history of surgery81.3%
Donor record incomplete or incorrect 191 30.7%
Donor history questions8213.2%
Donor identification508.0%
Donor signature missing386.1%
Donor did not meet acceptance criteria 169 27.2%
Medical review or physical not performed or inadequate12820.6%
Unacceptable address or no proof of address304.8%
Temperature unacceptable or not documented101.6%
Deferral screening not done or incorrectly performed 66 10.6%
Donor previously deferred due to history 61 9.8%
Reason for deferral unknown447.1%
Donor previously deferred due to testing 5 0.8%
Incorrect ID used during deferral search 4 0.6%
Donor not previously deferred 3 0.5%
Donor previously deferred due to history 1 0.2%

 

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III. BPD Reports Submitted by Manufacturers of Licensed Biological Products Other Than Blood and Blood Components (Licensed Non-Blood)

 

  • Licensed non-blood manufacturers submitted 152 more reports in FY10 than in the previous fiscal year (FY09-509) {Table 2}.
  • Vaccine manufacturers submitted 74 more reports (FY09-168)
    • The number of reports related to product specifications increased from 43 in FY09 to 91 in FY10. The number of reports related to product not meeting specifications increased from 28 in FY09 to 33 in FY10. There was an increase in the number of reports related to stability failures for potency (FY09-7, FY10-30)
    • The number of reports related to broken or cracked vials increased from 78 in FY09 to 84 in FY10
    • The number of reports related to product specifications increased from 43 in FY09 to 91 in FY10.  The number of reports related to product not meeting specifications increased from 28 in FY09 to 33 in FY10.
  • Allergenic manufacturers submitted 5 more reports (FY09-192)
    • Of 179 product specification reports, 97% (174) of these reports were related to precipitate discovered in allergenic extracts, which was similar to the previous fiscal year (FY09-96%{173 product specification reports/181 total reports})
  • Blood Derivative manufacturers submitted 35 more reports (FY09-64)
    • The number of reports related to process controls increased from 8 in FY09 to 35 in FY10
      • The number of reports related to process/procedures not performed or performed incorrectly increased from 5 in FY09 to 21 in FY10
      • The number of reports related to manufacturing or processing performed using incorrect parameters increased from 1 in FY09 to 11 in FY10
  • In Vitro Diagnostic manufacturers submitted 34 more reports (FY09-83)
    • The number of reports related to quality control and distribution increased from 11 in FY09 to 31 in FY10; most of these related to product received upside down or sideways within the shipping container
    • The number of reports related to the product specifications increased from 38 in FY09 to 52 in FY09; most of these related to product not meeting specifications for fill volume (FY09-16, FY10-20), appearance (FY09-4, FY10-9) or unexpected positive reactions in testing (FY09-0, FY10-7)
    • The number of reports involving labeling increased from 8 in FY09 to 14 in FY10
  • Licensed HCT/P manufacturers (351 HCT/P) submitted four more reports in FY10 (FY09-2)
    • In FY09, the reports involved process controls and testing. In FY10, the reports involved product specifications, incoming material, quality control and distribution and labeling

Total BPD Reports By Manufacturing System Licensed Non-Blood Establishments

Table 24

 

Manufacturing SystemAllergenicBlood DerivativeIn Vitro DiagnosticVaccine351 HCT/PTOTAL
Product Specifications179255291234952.8%
Quality Control & Distribution293193113620.6%
Process Controls9356130639.5%
Labeling7414161426.4%
Testing099140324.8%
Incoming Material0154112324.8%
Miscellaneous0214071.1%
Total 197991172426661100 %

 

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IV. HCT/P Deviation Reports Submitted by Manufacturers of 361 HCT/Ps

The deviation reporting requirement for HCT/Ps regulated solely under section 361 of the PHS Act and 21 CFR Part 1271 became effective on May 25, 2005. Cellular HCT/Ps includes hematopoietic stem/progenitor cells derived from peripheral and cord blood, therapeutic cells and autologous pancreatic islet cells . Non-Cellular HCT/Ps includes, but is not limited to, fascia, cartilage, bone ligament, tendon, vascular graft, tooth pulp, cornea, sclera, whole eye, limbal graft, skin, heart valve, dura mater, pericardium, amniotic membrane, nerve, parathyroid tissue, placenta, spinal cord, testicular tissue, trachea, and cardiac tissue (non-valved).

361 HCT/P manufacturers submitted 32 more reports in FY10 than in the previous fiscal year (FY09-254) {Table 2}.

 

  • There were 29 more reports involving cellular HCT/Ps submitted than in the previous fiscal year (FY09-131, FY10-160)
    • There was a increase from the previous fiscal year in the number of reports involving donor testing (FY09-4, FY10-27)
      • The number of reports involving testing using an unacceptable s pecimen increased from 1 in FY09 to 13 in FY10
      • The number of reports involving the use of an inappropriate test or test laboratory, specifically the required test used was not licensed, approved, or cleared increased from 2 in FY09 to 14 in FY10
    • The number of reports involving processing and process controls was similar to the previous fiscal year (FY09-66, FY10-64). There was an increase in reports of contamination or potential contamination during processing (FY09-59, FY10-64)
    • The number of reports involving r eceipt, pre-distribution, shipment and distribution was the same as the previous fiscal year (53 in FY09 and FY10). The number of reports involving distribution of product that was contaminated or potentially contaminated was similar to the previous fiscal year (FY09-50, FY10-52)
  • There were 3 more reports involving non-cellular HCT/Ps submitted than in the previous fiscal year (FY09-123, FY10-126)
    • The number of reports involving donor testing increased from 34 in FY09 to 56 in FY10.
      • There was an increase in the number of reports involving testing incorrectly performed (FY09-7, FY10-23)
      • The number of reports involving unacceptable samples used for testing was similar to the previous fiscal year (FY09-26, FY10-27). In FY10, most of these involved using filtered samples.
    • The number of reports involving donor screening increased from 7 in FY09 to 20 in FY10. There was an increase in the number of reports in which the donor medical history interview was performed incorrectly (FY09-5, FY10-18).
    • The number of reports involving donor eligibility was similar to the previous fiscal year (FY09-32, FY10-23). Of the 23 reports involving donor eligibility, 22 reports involved the acceptance of ineligible donors. 13 of these reports involved risk factors, clinical or physical evidence identified, and 7 reports involved incorrectly evaluating donor for plasma dilution.
    • The number of reports involving processing and process controls decreased from 35 in FY09 to 17 in FY10. There was a decrease in reports involving contamination or potential contamination during processing (FY09-34, FY10-15).

 

Total Reports By Manufacturing System 361 HCT/P Establishments

Table 25

 

HCT/P Deviation CodeCellular HCT/PNon-Cellular HCT/PTotal
Donor Testing27568329.0%
Processing and Processing Controls64178128.3%
Receipt, Pre-Distribution, Shipment & Distribution5345719.9%
Donor Eligibility323269.1%
Donor Screening120217.3%
Recovery9093.1%
Supplies and Reagents0441.4%
Labeling Controls1120.7%
Environmental Control1120.7%
Storage1010.3%
Total160126286100%

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V. Attachments

  1. Table - Number of BPD Reports by Type of Blood and Plasma Establishments (PDF - 1.3 MB)
  2. List of BPD Codes for Blood and Plasma Establishments (PDF - 352 KB)
  3. Table - Number of BPDs by Type of Licensed Non-Blood Establishment (PDF - 23 KB)
  4. List of BPD Codes for Licensed Non-Blood Establishments (PDF - 48 KB)
  5. Table - Number of HCT/P Deviations by Type of 361 HCT/P Establishment (PDF - 104 KB)
  6. List of HCT/P Deviation Codes for 361 HCT/P Establishments (PDF - 52 KB)
  7. List of Table (PDF - 22 KB)

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VI. References

  1. Guidance for Industry - Biological Product Deviation Reporting for Blood and Plasma Establishments 10/18/2006 
  2. Guidance for Industry - Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components 10/18/2006

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