Vaccines, Blood & Biologics

Annual Summary for Fiscal Year 2009

Download PDF Version of Reportpdficon


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

Back to the Biological Product Deviation Reports Annual Summaries


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 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, 2008 through September 30, 2009 (FY09), CBER’s Office of Compliance and Biologics Quality/Division of Inspections and Surveillance entered 50,282 deviation reports into the BPD database:

  • We received more than 50,282 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 12% increase in the number of reports received in FY09 compared to FY08 {Table 2}
    • We received 12% more reports from blood and plasma establishments in FY09 compared to FY08{Table 2}
    • We received 4% fewer reports from licensed blood establishments in FY09 compared to FY08 {Table 2}
    • We received 4% more reports from unlicensed registered blood establishments in FY09 compared to FY08 {Table 2}
    • We received 74 more reports from transfusion services in FY09 compared to FY08 {Table 2}
    • We received 54% more reports from licensed plasma centers in FY09 compared to FY08 {Table 2}.
  • We received 30% more reports from manufacturers of licensed biological products other than blood and blood components in FY09 compared to FY08 {Table 2}
  • Vaccine manufacturers submitted 71 more reports in FY09
  • Allergenic manufacturers submitted 23 more reports in FY09
  • Blood Derivative manufacturers submitted 15 more reports in FY09
  • In-vitro diagnostic manufacturers submitted five more reports in FY09
  • A licensed HCT/P manufacturer (351 HCT/P) submitted two reports in FY09 and none the previous year
We received 32 more reports from 361 HCT/P manufacturers in FY09 compared to FY08 {Table 2}
  • Cellular HCT/P manufacturers submitted nine fewer reports in FY09
  • Non-cellular HCT/P manufacturers submitted 40 more reports in FY09
  • The number of reporting establishments increased by 4% in FY09 compared to FY08 {Table 2} Compared to FY08, there were 35 more transfusion services and 46 more licensed plasma centers reporting in FY09.
  • Compared to FY08, there were 141 more establishments reporting electronically in FY09 [FY08-1,370 (81% of reporting establishments), FY09-1,511 (91% of reporting establishments)].
  • The percentage of reports submitted electronically remained the same as the previous year (90%) {Table 7}. There was an increase in the percentage of reports submitted electronically from licensed plasma centered (FY08-72%, FY09-77%), vaccine manufactures (FY08-11%, FY09-52%) and HCT/P manufacturers (FY08-74%, FY09-81%).
  • In FY09, the overall number of reports identified as potential recall situations decreased by 30% compared to FY08 {Table 2} . The overall decline is largely attributable to reports from blood establishments;
    • There was a 37% decrease in the number of reports blood establishments submitted that were identified as potential recall situations (FY08-1,961, FY09-1,228)
    • From the previous year, there were 12 more reports submitted by licensed plasma centers that were identified as potential recall situations (FY08-438, FY09-450)
    • There were 13 fewer reports involving licensed biological products other than blood and blood components identified as potential recall situations (FY07-11, FY08-17, FY09-4)
    • There were seven fewer reports involving HCT/Ps that were identified as potential recall situations (FY07-34, FY08-40, FY09-33)
  • In FY09, manufacturers submitted 91% of the blood and plasma BPD reports, 83% of the licensed biological product other than blood and blood component BPD reports, and 82% of the 361 HCT/P deviation reports within the required 45-day time frame. {Tables 31, 34, and 37}.

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

FY09

Table 1

Total Deviation Reports
FY09
Table 1
 

Number Of Reporting Establishments

Total Reports ReceivedPotential Recalls
Blood/Plasma Manufacturers
Licensed Blood Establishments246(191*)25,4811,1894.7%
Unlicensed Blood Establishments 14133,940391.0%
Transfusion Services 25761,93200.0%
Licensed Plasma Centers374(54*)18,1664502.5%
Sub-Total1,60949,5191,6783.4%
Licensed Non-Blood Manufacturers
Allergenic819200.0%
Blood Derivative186400.0%
In Vitro Diagnostic108311.2%
Vaccine1816831.8%
351 HCT/P1200.0%
Sub-Total5550940.8%

361 HCT/P Manufacturers

Cellular HCT/P4013110.8%
Non-Cellular HCT/P41123

32

26.0%

Sub-Total

812543313.0%
Total1,74550,2821,7153.4%

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

FY07 - FY09

Table 2

Total Deviation Reports
FY07 - FY09
Table 2
 

Number Of Reporting Establishments

Total Reports Received

Potential Recalls

Blood/Plasma ManufacturersFY07FY08FY09FY07FY08FY09FY07FY08FY09
Licensed Blood Establishments235(119*)258(121*)246(191*)29,35626,65525,4811,9491,9281,189
Unlicensed Blood Establishments4004174133,9143,7983,940343339
Transfusion Services5025415761,7971,8581,932100
Licensed Plasma Centers303(54*)328(42*)374(54*)7,76311,81418,166285438450
Sub-Total1,4401,5441,60942,83044,12549,5192,2692,3991,678

Licensed Non-Blood Manufacturers

Allergenic778174169192020
Blood Derivative161618594964270
In Vitro Diagnostic8910697883771
Vaccine1315186097168113
351 HCT/P101102100
Sub-Total45475536339350911174

361 HCT/P Manufacturers

Cellular HCT/P594840107140131721
Non-Cellular HCT/P2836414582123273832
Sub-Total878481152222254344033
Total1,5721,6751,74543,34544,74050,2822,3142,4561,715

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

Blood & Plasma BPD Reports By Manufacturing System

FY07 - FY09

Table 3

Blood & Plasma BPD Reports By Manufacturing System
Manufacturing SystemFY07FY08FY09
Donor Suitability32,28075.4%32,57973.8%37,61875.9%
Post Donation Information30,03370.1%30,15268.3%34,84370.3%
Donor Screening2,0274.7%2,2905.2%2,7265.5%
Donor Deferral2200.5%1370.3%490.1%
QC & Distribution4,55510.6%4,93711.2%4,8389.8%
Miscellaneous1,4003.3%1,9144.3%2,2614.6%
Labeling2,3095.4%2,2885.2%2,2604.6%
Laboratory Testing1,1632.7%1,1482.6%1,0402.1%
Routine Testing1,1032.6%1,1042.5%9982.0%
Viral Testing600.1%440.1%420.1%
Collection7041.7%7761.8%9962.0%
Component Preparation4191.0%4831.1%5061.0%
Total42,830100%44,125100%49,519100%

Licensed Non-Blood Deviation Reports By Manufacturing System

FY07 - FY09

Table 4

Licensed Non-Blood Deviation Reports By Manufacturing System FY 07 - FY 09
Manufacturing System

Allergenic

Blood Derivative

In Vitro Diagnostic

 FY07 FY08 FY09 FY07 FY08 FY09 FY07 FY08 FY09
Product Specifications155161181241835172838
Quality Control & Distribution00245491411
Process Controls1144138814914
Labeling34413428188
Testing5003881877
Incoming Material001237324
Miscellaneous000030001
Total174169192594964697883

Table 4 (continued)

Table 4 (continued)
Licensed Non-Blood Deviation Reports By Manufacturing System Table 4 Continued
Manufacturing System

Vaccine

351 HCT/P

Total

 FY07 FY08 FY09

FY08

FY07

FY09

Product Specifications355043000231257297
Quality Control & Distribution720840002039101
Process Controls3910101423037
Labeling6719000303333
Testing674001322220
Incoming Material1150006617
Miscellaneous233000264
Total6097168102363393509

361 HCT/P Deviation Reports By Manufacturing System

FY07 - FY09

Table 5

361 HCT/P Deviation Reports By Manufacturing System Table
Manufacturing System

Cellular HCT/Ps

Non-Cellular HCT/Ps

Total

 
FY07 FY08 FY09 FY07 FY08 FY09 FY07 FY08 FY09
Processing & Processing Controls155066218351768101
Receipt, Pre-Distribution, Shipment & Distribution253353735323658
Donor Testing5042441234545438
Donor Eligibility342213332243634
Recovery7861088814
Donor Screening02081578177
Labeling Controls000122122
Supplies and Reagents510100610
Environmental Control200000200
Storage000000000
Total1071401314583123152222254

We implemented the online electronic deviation report form on June 18, 2001. In FY09, 91% of all the facilities filing reports filed at least some reports electronically. The portion of all reports submitted electronically in FY09 was the same as the previous year (FY08 – 90.2%). We continue to encourage all reporters to use the electronic reporting format.

Deviation Reports Submitted Electronically

Table 6

Deviation Reports Submitted Electronically
 #Reporting EstablishmentsTotal Reports# of eBPDR% eBPDR

Blood/Plasma Manufacturers

Licensed Blood Establishments238(97%)25,48125,18598.8%
Unlicensed Blood Establishments382(92%)3,9403,72494.5%
Transfusion Services484(84%)1,9321,74290.2%
Licensed Plasma Centers303(81%)18,16613,96176.9%
Sub-Total1,407(87%)49,51944,61290.1%

Licensed Non-Blood Manufacturers

Allergenic7(88%)19219199.5%
Blood Derivative13(72%)645179.7%
In Vitro Diagnostic5(50%)835971.1%
Vaccine12(67%)1688852.4%
351 HCT/P0200.0%
Sub-Total37(67%)50938976.4%

361 HCT/P Manufacturers

Cellular HCT/P34(85%)1319471.8%
Non-Cellular HCT/P33(80%)12311190.2%
Sub-Total67(83%)25420580.7%
Total1,511(91%)50,28245,20689.9%

Percent of Deviation Reports Submitted Electronically

Table 7

Percent of Deviation Reports Submitted Electronically
 FY06FY07FY08FY09

Blood/Plasma Manufacturers

Licensed Blood Establishments70.8%94.3%98.6%98.8%
Unlicensed Blood Establishments90.2%93.7%93.8%94.5%
Transfusion Services78.8%88.3%88.6%90.2%
Licensed Plasma Centers61.1%77.1%71.5%76.9%
Sub-Total71.8%90.9%90.5%90.1%

Licensed Non-Blood Manufacturers

Allergenic

88.6%86.8%100.0%99.5%

Blood Derivative

51.4%55.9%79.6%79.7%

In Vitro Diagnostic

68.3%60.9%79.5%71.1%

Vaccine

9.8%11.7%11.3%52.4%

351 HCT/P

0.0%0.0%0.0%0.0%

Sub-Total

68.2%64.2%71.5%76.4%

361 HCT/P Manufacturers

Cellular HCT/P

74.3%80.4%70.7%71.8%

Non-Cellular HCT/P

64.3%71.1%79.3%90.2%

Sub-Total

69.4%77.6%73.9%80.7%

Total

71.7%90.6%90.2%89.9%

Back to the Top


II. BPD Reports Submitted By Blood and Plasma Establishments:

  • Blood and plasma establishments submitted 5,394 more reports in FY09 than in the previous year (FY08-44,125) {Table 2}.
  • Licensed blood establishments submitted 1,174 fewer reports (FY08-26,655)
    • The number of reports involving post donation information decreased from 19,656 in FY08 to 18,558 in FY09. Most frequently, these events related to donors who traveled to risk areas (FY08-10,898, FY09-10,158).
    • The number of reports involving quality control and distribution decreased from 2,025 in FY08 to 1,662 in FY09. Most frequently, these events related to bacterial detection testing (FY08-616, FY09-410).
    • The number of reports involving blood collection increased from 724 in FY08 to 929 in FY09. Most frequently, these events related to products that contained clots which were not discovered prior to distribution (FY08-417, FY09-599).
    • The number of reports involving donor screening increased from 1,698 in FY08 to 1,914 in FY09
  • The number of reports in which incorrect donor identification was used during the deferral search increased from 464 in FY08 to 918 in FY09, specifically the number of reports in which a donor was subsequently not found in the deferral file doubled (FY08-442, FY09-871)
  • The number of reports involving incomplete or incorrect donor records decreased (FY08-482, FY09-368)
  • The number of reports involving a donor who provided disqualifying information, or information that required follow-up, and was not deferred, decreased (FY08-572, FY09-496)
  • Unlicensed blood establishments submitted 142 more reports (FY08-3,798)
    • The number of reports involving quality control and distribution increased (FY08-1,798, FY09-1,916)
  • The number of reports involving a product that was not irradiated as required increased from 188 in FY08 to 228 in FY09
  • The number of reports involving a product not issued in the computer, which was the only documentation at the time the product was issued, increased from 631 in FY08 to 664 in FY09
  • Transfusion services submitted 74 more reports (FY08-1,858)
    • Unregistered transfusion services typically report few BPDs (67% of those reporting in FY09 submitted 1 or 2 reports) and may file no reports in a given year. Only 13% of the transfusion services submitted more than five reports during FY09.
    • The distribution of reports submitted in FY09 by transfusion services was similar to FY08
  • 1,070 reports involved quality control and distribution (FY08-993)
  • 534 reports involved labeling (FY08-519)
  • 322 reports involved routine testing (FY08-338)
  • Licensed plasma centers submitted 6,352 more reports (FY08-11,814)
    • The number of reports involving post donation information increased from 10,107 in FY08 to 15,871 in FY09, specifically involving donors who had a history of tattoo or piercing (FY08-6,893, FY09-11,136) or a history of incarceration (FY08-685, FY09-1,008)
    • The number of reports involving products that were collected and distributed from a donor who subsequently tested confirmed positive for a viral marker increased (FY08-1,038, FY09-1,363)
    • The number of reports involving donor screening increased from 508 in FY08 to 715 in FY09, specifically related to donors providing disqualifying information, mostly a history of tattoo or piercing, and not deferred (FY08-97, FY09-209)
  • There were 721 fewer reports identified by FDA as potential recall situations (FY08-2,399)

Non-Reportable Events

Most of these reports did not meet the reporting threshold because the events were either not associated with manufacturing, did not affect the safety, purity or potency of the product, or did not involve distributed products. Examples of non-reportable events include:

  • Establishment distributed product collected from a donor who provided post donation information of cold or flu symptoms
  • Establishment distributed product collected from a donor who did not meet suitability criteria related to donor safety only, such as time interval between donations, frequency of donations, or unacceptable blood pressure
  • Establishment distributed product labeled with a shortened expiration date. This includes associated labeling, such as crossmatch tag or transfusion record.
  • Hospital staff transfused the wrong patient, transfused the wrong product to a patient, or requested the wrong product from blood bank.
  • Establishment distributed an allogeneic unit when an autologous or directed unit was available
  • Establishment distributed products collected from a donor who tested negative on all required assays. The donor then returned and tested reactive or repeat reactive, but not confirmed positive for a viral marker (HIV, HBV or HCV) for which we require or recommend product quarantine or consignee notification (i.e., lookback).
  • ABO/Rh and/or antibody screen incorrectly performed on patient, but there were no products distributed based on the incorrect testing
  • Establishment distributed plasma for further manufacture collected from a donor who had a history of travel to a malarial endemic area
  • Establishment distributed a product collected from a donor who had a history of cancer or was diagnosed with cancer after donation
  • Establishment distributed a product collected from a donor who had a history of disease or was diagnosed with a disease after donation, which does not affect the safety, purity, or potency of the product. Examples of diseases include, but is not limited to, autoimmune diseases, hemochromatosis, ulcerative colitis, heart disease, ear or sinus infection

Deviation Code (BPD Code) Selection

In some cases, the establishment selected the incorrect deviation code to capture the event. This may be due to incorrect data entry of the BPD Code, or selecting a less specific code when a more appropriate code is available. When the wrong code is used, our reviewers notify the reporter and enter the report into our database using the proper code . The most common errors in coding deviations were:

  • Donor Screening (DS) vs. Post Donation Information (PD)
    • If the blood establishment does not know the disqualifying information at the time of donation, we consider the event to be post donation information. If the establishment knows the disqualifying information or the information is available at the time of donation, but does not appropriately defer the donor, or the deferral criteria is misinterpreted, the event is a donor screening deviation.
  • Routine Testing (RT) vs. Quality Control & Distribution (QC)
    • If a patient had a history of an antibody and the blood bank did not screen the unit, as required, for the corresponding antigen, the appropriate deviation code is QC-93-11 (Required testing not performed or documented for antigen screen), not RT-61-06 (Testing performed, interpreted, or documented incorrectly for antigen typing). You should use the routine testing (RT) codes if you (or your contract laboratory) perform the testing, but you performed, documented, or interpreted the testing incorrectly.
  • Post Donation Information (PD-11-**) vs. Miscellaneous (MI-02-**)
    • If the blood establishment receives information from a donor or third party of a reactive (including repeat reactive or confirmed positive) viral marker post donation, the deviation code should be PD-11-** (select third level code for the viral maker), if a previously collected unit was distributed
    • If the blood establishment determines the donor is confirmed positive for a viral marker (i.e., blood establishment or contractor performs testing), the deviation code should be MI-02-** (select third level code for the viral marker), if a previously collected unit was distributed
  • Use of QC-97-13 (QC & Distribution; Distribution procedure not performed in accordance with blood bank transfusion service’s specifications; Procedure for issuing not performed or documented in accordance with specifications) when a more specific code is available
  • If the product is issued without identifying that the recipient identification is incorrect or missing, the deviation code should be LA-82-07, Labeling; Crossmatch tag or tie tag incorrect or missing information; Recipient identification incorrect or missing
  • If the blood bank does not issue, or incorrectly issues, the product through the computer system and this is the only method of documenting the visual and clerical checks at time of issue, the deviation code should be QC-97-19, Product not documented or incorrectly documented as issued in the computer

Product Information

When blood establishments report deviations associated with the distribution of a licensed non-blood products, (e.g., Rh Immune Globulin, factor concentrates), the blood deviation codes appropriate for the event should be selected. The product code should be DB00 (Other), and the report should include a description of the specific product.

When an establishment notifies the consignee, whether the purpose of the notification is to determine the disposition of the product or to attempt to retrieve the product, the Notification field should be entered as Yes.

Total BPDRs By Manufacturing System

Blood and Plasma Establishments

Table 8

Total BPDRs By Manufacturing System Blood and Plasma Establishent
Manufacturing SystemLicensed Blood Establishments

Unlicensed Blood Establishments

Transfusion ServicesLicensed Plasma Centers

Total

DS-Post Donation Information18,558414NA15,87134,84370.4%
QC & Distribution1,6621,9161,0701904,8389.8%
DS-Donor Screening1,91497NA7152,7265.5%
Miscellaneous88414NA1,3632,2614.6%
Labeling74997053472,2604.6%
LT-Routine Testing28938732209982.0%
Blood Collection92954NA139962.0%
Component Preparation42079615061.0%
DS-Donor Deferral376NA6490.1%
LT-Viral Testing393NA0420.1%
Total25,4813,9401,93218,16649,519100%

DS-Donor Suitability

LT-Laboratory Testing

NA-Not applicable : manufacturing not performed in transfusion service

Potential Recalls By Manufacturing System

Blood and Plasma Establishments

Table 9

Potential Recalls By Manufacturing System Blood and Plasma Establishents
Manufacturing SystemLicensed Blood Establishments

Unlicensed Blood Establishments

Transfusion Services

Licensed Plasma Centers

Total

DS-Donor Screening66219NA3931,07464.0%
QC & Distribution2981404936121.5%
Component Preparation75400794.7%
Blood Collection540NA4583.5%
Labeling46101482.9%
DS-Donor Deferral221NA3261.5%
LT-Viral Testing180NA0181.1%
LT-Routine Testing14000140.8%
Total1,1893904501,678100%

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 (70% of deviation reports) {Table 8}. Most often (82% of PDI reports), the collection facility becomes aware of disqualifying information during a subsequent donation interview {Table 10}. In 94% of the PDI reports, the donor was aware of the information, but the donor screening process failed to elicit the information {Table 11}. The most common PDI relates to travel (31%).

We continue to encourage blood establishments and the industry to review donor screening processes to reduce the frequency of post donation information. Some work has begun (Ref. 1, 2) but there is a clear need to understand the root cause of donors not providing accurate information at the time of donation and to identify and spread successful strategies that reduce the occurrence of PDI.

Reports of Post Donation Information (PDI)

Blood and Plasma Establishments

Table 10

Reports of Post Donation Information (PDI) Blood and Plasma Establishments
PDI OBTAINED THROUGH:LICENSED BLOOD ESTABLISHMENTSUNLICENSED BLOOD ESTABLISHMENTS

LICENSED PLASMA CENTERS

TOTAL

Subsequent Donation17,03239811,12528,55581.9%
Third Party (e.g., doctor, family)39454,7005,09914.6%
Telephone Call from Donor9938451,0463.0%
Telerecruitment139311430.4%
Total18,55841415,87134,843100%

Table 11

 

Table 11
THE PDI WAS:

LICENSED BLOOD ESTABLISHMENTS

UNLICENSED BLOOD ESTABLISHMENTS

LICENSED PLASMA CENTERS

TOTAL

Known, but not Provided at Time of Donation*17,29238715,03532,71493.8%
Not Known at Time of Donation**1,266278362,1296.1%
Total18,55841415,87134,843

* Known, e.g., travel outside of U.S., tattoo or body piercing, history of disease, male to male sexual contact, medication
**Not known, e.g., post donation illness, sex partner participated in high risk behavior or tested positive subsequent to donation

Blood establishments submitted 1,073 fewer reports in FY09 compared to FY08 involving post donation information. They submitted 747 fewer reports involving travel to malarial endemic areas or variant Creutzfeldt-Jakob Disease (vCJD) risk areas.

  • Licensed plasma centers submitted 5,764 more reports in FY09 compared to FY08 involving post donation information. Most of these reports involved donors who had a history of tattoo and/or piercing or a history of incarceration.
  • Table 12 illustrates the major differences in post donation information reports from FY08 to FY09. It does not include all post donation information reports. In FY09, we determined that some of the diseases or conditions previously reported as history of disease or post donation illness do not affect the safety, purity, or potency of a product and therefore, were not reportable. The increase in post donation information reports from licensed plasma centers is reflective of the increase in the number of facilities submitting more reports in general.

PDI Reports submitted by Blood and Plasma Establishments

Table 12

PDI Reports submitted by Blood and Plasma Establishments

Blood Establishments

FY08

FY09

Post Donation Information (PD) - total

20,04518,972

Donor had a history of travel to malarial risk area

7,2166,654

Donor had a history of travel to vCJD risk area

3,8713,683

Post donation illness

1,2131,029

Donor had a history of disease or surgery

443271

Licensed Plasma Centers

FY08

FY09

Post Donation Information (PD) - total

10,10715,871

Donor received tattoo and/or piercing

7,24011,731

Donor had a history of incarceration

6851,008

Donor had a history of non-sexual exposure to hepatitis C

394563

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) increased by 18% from the previous year. The number of these reports submitted by blood establishments increased by 3% (FY08-852, FY09-874) and the number of these reports submitted by licensed plasma establishments increased by 31% (FY08-1,038, FY09-1,363). The majority of this increase in reports involved donors who subsequently tested confirmed positive for Hepatitis C. Table 13 illustrates the number of reports related to units collected from donors who subsequently tested confirmed positive for selected viral markers.

Last year we reported that CBER’s Blood Safety Team found this trend from FY06 to FY08 was primarily due to increased donor activity and a shift in reporting patterns following release of our guidance in October 2006 (Ref. 3).

This year, the apparent rise in blood establishment HCV seroconversions was mostly attributable to unreported events discovered over the past several years which were reported in FY09. Without these additional reports, the numbers reported in FY09 are comparable to previous years. Although there have been more Source Plasma collection centers opened and more donors collected, we have insufficient data to determine if increased donor activity is the primary cause of the trend.

We encourage individual firms to monitor and evaluate seroconversion rates among their donor population (Ref. 4, 5, 6). Table 13 illustrates the number of reports related to units collected from donors who subsequently tested confirmed positive for selected viral markers.

Reports Submitted by Blood and Plasma Establishments

Table 13

Reports Submitted by Blood and Plasma Establishments Table 13
Blood Establishments

FY05

FY06

FY07

FY08

FY09

Lookback; Subsequent unit confirmed positive (MI02) - total

431510721852874

HCV (MI0204)

293309315405527

HIV (MI0202)

8488120152133

HBV (MI0203)

3496163140127
Licensed Plasma Centers

FY05

FY06

FY07

FY08

FY09

Lookback; Subsequent unit confirmed positive (MI02) - total

64986461,0381,363

HCV (MI0204)

4063393579814

HBV (MI0203)

1623171324401

HIV (MI0202)

81381129146

Potential Recalls

Of the 1,678 reports blood and plasma establishments submitted, deviations and unexpected events that occur during the donor screening process continue to be the leading cause of potential recall situations (64%) {Table 9}. Table 14 illustrates the potential recall situations by manufacturing system.

Potential Recalls by Manufacturing System

Blood and Plasma Establishments

Table 14

Potential Recalls by Manufacturing System Blood and Plasma Establishments Table 14
 

Blood Establishments

Licensed Plasma Centers

Manufacturing SystemFY08FY09FY08FY09
Donor Screening849681333393
QC & Distribution5973126049
Blood Collection1355434
Donor Deferral7923143
Labeling844711
Component Preparation1127930
Viral Testing251820
Routine Testing231400
Post Donation Information570220
Total19611228438450
  • Table C illustrates the most common potential recall reports involving donor screening. It does not include all donor screening reports.

Potential Recalls

Blood and Plasma Establishments

Table 15

 

 

 

 

Potential Recalls Blood and Plasma Establishments Table 15
 

Blood Establishments

Licensed Plasma Centers

FY07FY08FY09FY07FY08FY09
Donor Screening (DS) - total758830681

209

333

Donor gave info, not deferred (DS29)460468398

31

92

Donor didn't meet acceptance criteria (DS21)262414

78

73

Donor record incomplete or incorrect (DS22)233311226

69

136

A. Most Frequent BPD Reports Submitted by Licensed Blood Establishments

Of the 25,481 reports submitted by licensed blood establishments, 18,558 (72.8%) reports involved post donation information.

  • The number of these reports decreased by 6% (FY08-19,656)
  • The number of reports in which a donor or third party provided subsequent information related to high risk behavior or history decreased by 5% (FY08-18,182)
    • The number of reports in which a donor or third party provided subsequent information regarding travel to a malaria risk area decreased by 8% (FY08-7,075)
    • The number of reports in which a donor or third party provided subsequent information regarding travel to a vCJD risk area decreased by 5% (FY08-3,795)
  • The number of reports in which a donor or third party provided subsequent information related to post donation illness decreased by 15% (FY08-1,261)

Most Frequent BPD Reports - Post Donation Information

From Licensed Blood Establishments

Table 16

Most Frequent BPD Reports - Post Donation Information from License Blood Establishments

POST DONATION INFORMATION (PD) 18,558

# Reports

% of Total (PD)

Behavior/History

17,303 93.2%

Travel to malaria endemic area/history of malaria

6,52135.1%

Risk factors associated with Creutzfeldt-Jakob Disease (CJD) – travel

3,59419.4%

Donor received tattoo

9985.4%

Male donor had sex with another man

8584.6%

Received finasteride (Proscar/Propecia), Tegison, Accutane, or Avodart

6833.7%

IV drug use

4612.5%

Illness

1,068 5.8%

Post donation illness (not hepatitis, HIV, HTLV-I, STD, or cold/flu related)

1,0145.5%

Post donation diagnosis or symptoms of Hepatitis C

140.1%

Post donation diagnosis or symptoms of hepatitis, not specified

110.1%

Testing *

129 0.7%

Tested reactive for HIV prior to donation

290.2%

Tested reactive for Hepatitis C post donation

250.1%

Tested reactive for HIV post donation

150.1%

Not specifically related to high risk behavior

58 0.3%

Donated to be tested or called back for test results

370.2%

Donor does not want their blood used

200.1%

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

Of the 25,481 reports submitted by licensed blood establishments, 1,914 (7.5%) reports involved donor screening deviations or unexpected events.

  • The number of these reports increased by 13% (FY08-1,698)
  • The number of reports in which the incorrect identification was used during the deferral search doubled from 464 in FY08 to 918 in FY09
  • The number of reports in which the donor record was incomplete or incorrect decreased by 24% (FY08-482)
  • The number of reports related to donor history questions decreased from 407 in FY08 to 314 in FY09
  • The number of reports in which the donor gave history which warranted deferral or follow up and was not deferred decreased by 13% (FY08-572)
  • The number of reports related to the donor providing a history of travel to a malaria risk or vCJD risk area decreased from 389 in FY08 to 361 in FY09

Most Frequent BPD Reports – Donor Screening

From Licensed Blood Establishments

Table 17

Most Frequent BPD Reports – Donor Screening from Licensed Blood Establisments

DONOR SCREENING (DS) 1,914

# Reports

% of Total (DS)

Incorrect ID used during deferral search

918 48.0%

Donor not previously deferred

86845.4%

Donor previously deferred due to history

301.6%

Donor previously deferred due to testing

201.0%

Donor gave history which warranted deferral or follow up and was not deferred

496 25.9%

Travel to malaria endemic area/history of malaria

27414.3%

Risk factors associated with Creutzfeldt-Jakob Disease (vCJD) – travel

814.2%

Received medication or antibiotics

281.5%

Donor record incomplete or incorrect

365 19.1%

Donor history questions

31416.4%

Incorrect gender specific question asked

20410.7%

Donor identification

170.9%

Donor signature missing

170.9%

Donor did not meet acceptance criteria

98 5.1%

Hemoglobin or Hematocrit unacceptable or not documented or testing was performed incorrectly

834.3%

Temperature unacceptable or not documented

100.5%

Deferral screening not done or incorrectly performed

32 1.7%

Donor not previously deferred

160.8%

Donor previously deferred due to history

100.5%

Donor previously deferred due to testing

60.3%

Of the 25,481 reports submitted by licensed blood establishments, 1,662 (6.5%) reports involved quality control and distribution deviations or unexpected events.

  • The number of these reports decreased by 18% (FY08-2,025)
  • The number of reports involving the release of a product with unacceptable, undocumented, or incomplete product QC decreased 23% (FY08-938)
    • There was a decrease of 33% (FY08-616) in reports specifically related to bacterial detection testing used as a quality control test. The industry implemented a standard for bacterial detection testing in March 2004.

Most Frequent BPD Reports –Quality Control & Distribution

From Licensed Blood Establishments

Table 18

Most Frequent BPD Reports – Quality Control & Distribution From Licensed Blood Establishments Table 18

QC & DISTRIBUTION (QC) 1,662

# Reports

% of Total (QC)

Distribution of product that did not meet specifications

1,240 74.6%

Product QC unacceptable, not performed, not documented, or incomplete

72543.6%

Bacterial detection testing

41024.7%

Platelet count

1277.6%

White Blood Cell count

613.7%

Product in which instrument QC or validation was unacceptable, incomplete or not documented

16910.2%

Other - Product distributed prior to required record review

794.8%

Product identified as unsuitable due to a collection deviation or unexpected event

684.1%

Product identified as unsuitable due to a donor screening deviation or unexpected event

432.6%

Shipping and storage

204 12.3%

Product not packaged in accordance with specifications or no documentation that product was packed appropriately

653.9%

Product arrived at consignee at unacceptable temperature

442.6%

No documentation that product was shipped or stored at appropriate temperature

372.2%

Distribution procedures not performed in accordance with blood bank transfusion service’s specifications

117 7.0%

Product not documented or incorrectly documented as issued in the computer

392.3%

Product not irradiated as required

231.4%

Improper ABO or Rh type selected for patient

120.7%

Product not leukoreduced as required

120.7%

Testing not performed, incompletely performed, or not documented

60 3.6%

Antigen screen

150.9%

Antibody screen or identification

90.5%

Failure to quarantine unit due to medical history:

26 1.6%

Post donation illness

161.0%

Positive testing

15 0.9%

Of the 25,481 reports submitted by licensed blood establishments, 929 (3.6%) reports involved blood collection deviations or unexpected events.

  • The number of these reports increased by 28% (FY08-724)
      • The number of reports involving the collection process increased by 40% (FY08 – 583)
    • The number of reports of clotted units increased by 43% (FY08 – 417)
    • The number of reports of hemolyzed units increased from 47 in FY08 to 79 in FY09
      • The number of reports involving the collection bag decreased from 49 in FY08 to 31 in FY09

Most Frequent BPD Reports – Blood Collection

From Licensed Blood Establishments

Table 19

Most Frequent BPD Reports – Blood Collection from License Blood Establishments Table 19

BLOOD COLLECTION (BC) 929

#Reports

% of Total (BC)

Collection process

814 87.6%

Product contained clots, not discovered prior to distribution

59964.5%

Product hemolyzed, not discovered prior to distribution

798.5%

Apheresis collection process

697.4%

Sterility compromised

77 8.3%

Arm prep not performed or performed inappropriately

343.7%

Bacterial contamination

242.6%

Air contamination

181.9%

Collection bag

31 3.3%

Potential collection set defect

151.6%

Blood drawn into outdated bag

121.3%

Of the 25,481 reports submitted by licensed blood establishments, 884 (3.2%) reports involved miscellaneous deviations or unexpected events.

  • The number of these reports increased by 3% (FY08-856).
  • The number of reports in which products were collected and distributed from a donor who subsequently tested confirmed positive increased from 832 in FY08 to 860 in FY09.
  • The number of reports in which a donor subsequently tested confirmed positive for HCV increased by 31% (FY08-398)
  • The number of reports in which a donor subsequently tested confirmed positive for Chagas or West Nile Virus decreased by 43% (FY08-111)
  • The number of reports in which a donor subsequently tested confirmed positive for HIV (149 in FY08 to 132 in FY09) and HBV (138 in FY08 to 126 in FY09) also decreased

Most Frequent BPD Reports - Miscellaneous

From Licensed Blood Establishments

Table 20

Most Frequent BPD Reports - Miscellaneous from License Blood Establishmens Table 20

MISCELLANEOUS (MI) 884

# Reports

% of Total (MI)

Lookback; subsequent unit tested confirmed positive for:

860 97.3%

HCV

52158.9%

HIV

13214.9%

HBV

12614.3%

2x Anti-HBc positive

445.0%

Chagas

485.4%

HTLV

182.0%

West Nile Virus

151.7%

Donor implicated in transfusion associated disease

24 2.7%

Babesia

171.9%

B. Most Frequent BPD Reports Submitted by Unlicensed Blood Establishments

Of the 3,940 reports submitted by unlicensed blood establishments, 1,916 (45.6%) involved quality control and distribution deviations or unexpected events.

  • The number of these reports increased by 7% (FY08-1,798)
  • The number of reports involving distribution procedures not performed in accordance with the blood bank transfusion service’s specifications increased by 8% (FY08-1,300)
    • 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 by 6% (FY08-627)
    • The number of reports involving the release of a product that was not irradiated as required increased by 21% (FY08-188)

Most Frequent BPD Reports - Quality Control & Distribution

From Unlicensed Blood Establishments

Table 21

Most Frequent BPD Reports - Quality Control & Distribution from Unlicensed Blood Establishents

QC & DISTRIBUTION (QC) 1,916

# Reports

% of Total (QC)

Distribution procedures not performed in accordance with blood bank transfusion service’s specifications

1,406 73.4%

Product not documented or incorrectly documented as issued in the computer

66434.7%

Product not irradiated as required

22811.9%

Improper product selected for patient

1186.2%

Improper ABO or Rh type selected for patient

854.4%

Product issued to wrong patient

562.9%

Testing not performed, incompletely performed, or not documented

298 15.6%

Antibody screen or identification

814.2%

ABO and Rh

673.5%

Compatibility

542.8%

Antigen screen

532.8%

Distribution of product that did not meet specifications

167 8.7%

Product QC unacceptable, not performed, not documented or incomplete

733.8%

Bacterial detection testing

422.2%

Product in which instrument QC or validation unacceptable, incomplete or not documented

361.9%

Outdated product

311.6%

Shipping and storage

34 1.8%

Product not packed in accordance with specifications or no documentation that product was packed appropriately

120.6%

Stored at incorrect temperature

80.4%

No documentation that product was shipped or stored at appropriate temperature

60.3%

Temperature not recorded or unacceptable upon return, unit redistributed

50.3%

Of the 3,940 reports submitted by unlicensed blood establishments, 970 (24.6%) involved labeling deviations or unexpected events.

  • The number of these reports was similar to the reports received in the previous fiscal year (FY08-948)
  • The number of reports involving crossmatch tag or tie tag labeled with incorrect or missing information, increased by 9% (FY08-505)
  • The number of reports involving the unit labeled with incorrect or missing information was similar to the reports received in the previous fiscal year (FY08-265)
  • The number of reports involving the transfusion record labeled with incorrect or missing information was similar the reports received in the previous fiscal year (FY08-177)

Most Frequent BPD Reports - Labeling

From Unlicensed Blood Establishments

Table 22

Most Frequent BPD Reports - Labeling from Unlicensed Blood Establishments Table 22

LABELING (LA) 970

#Reports

% of Total (LA)

Crossmatch tag or tie tag labels incorrect or missing information

550 56.7%

Recipient identification incorrect or missing

14014.4%

Crossmatch tag switched, both units intended for the same patient

12813.2%

Unit, lot, or pool number incorrect or missing

11511.9%

Labels applied to blood unit or product incorrect or missing information

251 25.9%

Extended expiration date or time

9810.1%

Product type or code incorrect

363.7%

Irradiation status incorrect or missing

333.4%

Transfusion record (crossmatch slip) incorrect or missing information

169 17.4%

Transfusion record switched, both units intended for the same patient

40

4.1%

Unit, lot, or pool number incorrect or missing

36

3.7%

Recipient identification incorrect or missing

35

3.6%

Of the 3,940 reports submitted by unlicensed blood establishments, 414 (10.5%) reports involved post donation information.

  • The number of these reports increased by 6% (FY08-389)
  • The number of reports in which a donor or third party provided subsequent information related to high risk behavior or history increased by 11% (FY08-350)
    • The number of reports in which a donor or third party provided subsequent information regarding travel to a malarial or vCJD risk area was similar to the previous fiscal year (FY08-214, FY09-222)
  • The number of reports in which a donor or third party provided subsequent information related to post donation illness decreased from 32 in FY08 to 17 in FY09

Most Frequent BPD Reports - Post Donation Information

From Unlicensed Blood Establishments

Table 23

Most Frequent BPD Reports - Post Donation Information from Unlicensed Blood Establishments Table 23

POST DONATION INFORMATION (PD) 414

# Reports

% of Total (PD)

Behavior/History

389

94.0%

Travel to malaria endemic area/history of malaria

133

32.1%

Risk factors associated with Creutzfeldt-Jakob Disease (vCJD) – travel

89

21.5%

Donor received tattoo

15

3.6%

Illness

17

4.1%

Testing*

8

1.9%

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

Of the 3,940 reports submitted by unlicensed blood establishments, 387 (9.8%) reports involved routine testing deviations or unexpected events.

  • The number of these reports decreased by 13% (FY08-444)
  • The number of reports involving testing that was performed, interpreted or documented incorrectly decreased by 16% (FY08-237)
  • The number of reports involving unacceptable reagent QC or the use of expired reagents decreased from 89 in FY08 to 63 in FY09

Most Frequent BPD Reports - Routine Testing

From Unlicensed Blood Establishments

Table 24

Most Frequent BPD Reports - Routine Testing from Unlicense Blood Establishment
ROUTINE TESTING (RT) 387

# Reports

% of Total (RT)

Testing performed, interpreted, or documented incorrectly

199

51.4%

Compatibility

66

17.1%

Antibody screening or identification

65

16.8%

Immediate spin performed instead of full crossmatch3910.1%
Electronic performed instead of full crossmatch51.3%
Antigen typing

31

8.0%

Sample (used for testing) identification

125

32.3%

Sample used for testing was incorrectly or incompletely labeled

94

24.3%

Unsuitable sample used for testing (e.g., too old)

29

7.5%

Incorrect sample tested

2

0.5%

Reagent QC unacceptable or expired reagents used

63

16.3%

Antibody screening or identification

19

4.9%

Multiple testing

10

2.6%

Antigen typing

9

2.3%

C. Most Frequent BPD Reports Submitted by Transfusion Services

Of the 1,932 reports submitted by transfusion services, 1,070 (55.4%) reports involved quality control and distribution deviations or unexpected events.

  • The number of these reports increased by 8% (FY08-993)
  • 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 from 347 in FY08 to 328 in FY09
  • The number of reports involving testing not performed, incompletely performed or not documented increased by 34% (FY08-191)

Most Frequent BPD Reports - Quality Control & Distribution

From Transfusion Services

Table 25

Most Frequent BPD Reports - Quality Control & Distribution

QC & DISTRIBUTION (QC) 1,070

# Reports

% of Total (QC)

Distribution procedures not performed in accordance with blood bank transfusion service’s specifications

731

68.3%

Product not documented or incorrectly documented as issued in the computer

328

30.7%

Product not irradiated as required

83

7.8%

Procedure for issuing not performed or documented in accordance with specifications

62

5.8%

Improper product selected for patient

55

5.1%

Improper ABO or Rh type selected for patient

52

4.9%

Product issued to the wrong patient

34

3.2%

Product released prior to obtaining current sample for ABO, Rh, antibody screen and/or compatibility testing

31

2.9%

Product not irradiated and CMV negative as required

19

1.8%

Testing not performed, incompletely performed, or not documented

256

23.9%

Antibody screen or identification

86

8.0%

Antigen screen

61

5.7%

ABO and Rh

49

4.6%

Distribution of product that did not meet specifications:

55

5.1%

Outdated product

26

2.4%

Product QC unacceptable, not performed, not documented or incomplete

10

0.9%

Shipping and storage

25

2.3%

No documentation that product was shipped or stored at appropriate temperature

8

0.7%

Stored at incorrect temperature

7

0.7%

Product not packed in accordance with specifications or documented that product was packed appropriately

5

0.5%

Of the 1,932 reports submitted by transfusion services, 534 (27.6%) reports involved labeling deviations or unexpected events.

  • The number of these reports were similar to the reports received in the previous year (FY08-519)
  • The number of reports involving the labeling of the product decreased from 67 in FY08 to 51 in FY09.
  • The number of reports involving the labeling of the crossmatch or tie tag increased from 299 in FY08 to 326 in FY09

Most Frequent BPD Reports - Labeling

From Transfusion Services

Table 26

Most Frequent BPD Reports - Labeling From Transfusion Services Table 26

LABELING (LA) 534

# Reports

% of Total (LA)

Crossmatch tag or tie tag labels incorrect or missing information

326

61.0%

Recipient identification incorrect or missing

112

21.0%

Crossmatch tag switched, both units intended for the same patient

60

11.2%

Unit, lot, or pool number incorrect or missing

41

7.7%

Crossmatch tag or tie tag missing or attached to incorrect unit

23

4.3%

Expiration date or time extended or missing

19

3.6%

Transfusion record (crossmatch slip) incorrect or missing information

157

29.4%

Recipient identification incorrect or missing

33

6.2%

Transfusion records switched, both units intended for the same patient

31

5.8%

Unit, lot, or pool number incorrect or missing

25

4.7%

Irradiation status incorrect or missing

13

2.4%

Labels applied to blood unit or product incorrect or missing information

51

9.6%

Extended expiration date or time

25

4.7%

Donor number or lot number incorrect or missing

8

1.5%

Product type or code incorrect

7

1.3%

ABO and/or Rh incorrect

4

0.7%

Of the 1,932 reports submitted by transfusion services, 322 (16.7%) 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 (FY08-338)

Most Frequent BPD Reports - Routine Testing

From Transfusion Services

Table 27

Most Frequent BPD Reports - Routine Testing From Transfusion Services Table 27
ROUTINE TESTING (RT) 322

# Reports

% of Total (RT)

Testing performed, interpreted, or documented incorrectly

179

55.6%

Antibody screening or identification

58

18.0%

Compatibility

50

15.5%

Immediate spin performed instead of full crossmatch3711.5%
Antigen typing

31

9.6%

Rh typing

17

5.3%

Sample (used for testing) identification

81

25.2%

Sample used for testing was incorrectly or incompletely labeled

56

17.4%

Unsuitable sample used for testing

12

3.7%

Incorrect sample tested

12

3.7%

Reagent QC unacceptable or expired reagents used

62

19.3%

Antigen typing

22

6.8%

Antibody screening or identification

12

3.7%

ABO

10

3.1%

Multiple testing

9

2.8%


D. Most Frequent BPD Reports Submitted by Licensed Plasma Centers

Of the 18,166 reports submitted by licensed plasma centers, 15,871 (87.4%) involved post donation information.

  • The number of these reports increased by 57% (FY08-10,107)
  • The number of reports in which a donor or third party provided subsequent information related to high risk behavior or history increased by 59% (FY08-9,730)
    • The number of post donation information reports in which the donor had a history of a tattoo and/or piercing increased by 62% (FY08-6,892, FY09-11,136)
    • The number of post donation information reports in which the donor had a history of incarceration increased 47% (FY08-685)
  • The number of reports in which a donor or third party provided subsequent information related to testing increased by 18% (FY08-349)
    • The number of reports in which the donor tested positive, specific testing unknown, by another facility increased by 28% (FY08-235)

Most Frequent BPD Reports - Post Donation Information

From Licensed Plasma Centers

Table 28

Most Frequent BPD Reports - Post Donation Information From Licensed Plasma Centers Table 28
POST DONATION INFORMATION (PD) 15,871

# Reports

% of Total (PD)

Behavior/History

15,454

97.4%

Donor received tattoo

7,550

47.6%

Donor received body piercing

2,595

16.4%

Incarcerated

1,008

6.4%

Donor received ear piercing

991

6.2%

Non-sexual exposure to Hepatitis C

441

2.8%

Donor received tattoo and piercing

595

3.7%

Risk factors associated with Creutzfeldt-Jakob Disease (vCJD) – travel

349

2.2%

Testing *

411

2.6%

Tested reactive at another center, specific testing unknown

300

1.9%

Tested reactive for HCV post donation

49

0.3%

Tested reactive for HBV post donation

23

0.1%

Tested reactive for HIV post donation

20

0.1%

Illness

6

0.0%

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

Of the 18,166 reports submitted by licensed plasma centers, 1,363 (7.5%) reports involved miscellaneous deviations or unexpected events.

  • The number of these reports increased by 31% (FY08-1,038)
  • The number of reports in which products were collected and distributed from a donor who subsequently tested confirmed positive for HCV increased by 40% (FY08-579)
  • The number of reports in which products were collected and distributed from a donor who subsequently tested confirmed positive for HBV increased 24% (FY08-324)
  • The number of reports in which products were collected and distributed from a donor who subsequently tested confirmed positive for HIV increased from 126 in FY08 to 146 in FY09

Most Frequent BPD Reports - Miscellaneous

From LicensedPlasma Centers

Table 29

Most Frequent BPD Reports - Miscellaneous From LicensedPlasma Centers Table 29
MISCELLANEOUS (MI) 1,363

# Reports

% of Total (MI)

Lookback; subsequent unit tested confirmed positive for:

1,363

100.0%

HCV

814

59.7%

HBV

401

29.4%

HIV

146

10.7%

Of the 18,166 reports submitted by licensed plasma centers, 715 (3.9%) reports involved donor screening deviations or unexpected events.

  • The number of these reports increased by 41% (FY08-508)
  • The number of reports in which the donor gave history which warranted deferral or follow up and was not deferred increased from 97 in FY08 to 209 in FY09
  • The majority of these events involved donors who had a history of a tattoo and/or piercing (FY08-61, FY09-118)

Most Frequent BPD Reports - Donor Screening

From LicensedPlasma Centers

Table 30

Most Frequent BPD Reports - Donor Screening From LicensedPlasma Centers Table 30
DONOR SCREENING (DS) 715

# Reports

% of Total (DS)

Donor record incomplete or incorrect

227

31.7%

Donor history questions

97

13.6%

Donor identification

49

6.9%

Donor signature missing

33

4.6%

Donor gave history which warranted deferral or follow up and was not deferred

209

29.2%

Donor received tattoo

81

11.3%

Donor received ear/body piercing

37

5.2%

Donor had history of surgery

37

5.2%

Risk factors associated with Creutzfeldt-Jakob Disease (vCJD) - travel

10

1.4%

Donor did not meet acceptance criteria

200

28.0%

Medical review or physical not performed or inadequate

126

17.6%

Unacceptable address or no proof of address

58

8.1%

Temperature unacceptable or not documented

14

2.0%

Deferral screening not done or incorrectly performed

74

10.3%

Donor previously deferred due to history

64

9.0%

Donor unreliable/unacceptable address111.5%
IV drug use71.0%
Donor previously deferred due to testing

9

1.3%

Incorrect ID used during deferral search

5

0.7%

Donor previously deferred due to history

3

0.4%

Donor previously deferred due to testing

1

0.1%

E. Timeliness of BPD Reports

BLOOD AND PLASMA ESTABLISHMENTS

Adherence To 45 Day Required Timeframe For Reporting

(Reporting Time = Date of FDA receipt – Date of discovery of BPD)

Table 31

Adherence To 45 Day Required Timeframe For Reporting
Reporting Time (days)

Licensed Blood Establishments

Unlicensed Blood Establishments

Transfusion Services

Licensed Plasma Centers

Total

< or = 45

24,353

96%

3,241

82%

1,67887%15,649

86%

44,921

91%

> 45 and <=90

838

3%

399

10%

1739%1179

6%

2,589

5%

> 90

290

1%

300

8%

814%1338

7%

2,009

4%

Total

25,481

100%

3,940

100%

1,932100%18,166

100%

49,519

100%

*Reporting time=0

26

 

60

 104 7 

197

 

*Reporting time = 0 - reports were submitted electronically on the day discovered
**1 report did not have discovered date entered

This chart shows the reporting time and the percentage of total Biological Product Deviation Reports submitted by Blood and Plasma establishments. Licensed Blood Establishments submitted 96% of their reports within 45 days of discovery, 3% of their reports between 45 and 90 days, and 1% of their reports greater than 90 days. Unlicensed Blood Establishments submitted 82% of their reports within 45 days of discovery, 10% between 45 and 90 days, and 8% greater than 90 days. Transfusion Services submitted 87% of their reports within 45 days of discovery, 9% their reports between 45 and 90 days, and 4% of their reports greater than 90 days.  Licensed Plasma Centers submitted 86% of their reports within 45 days of discovery, 6% of their reports between 45 and 90 days, and 7% of their reports greater than 90 days.  Total number of reports - 49,519; Licensed Blood Establishments - 25,481; Unlicensed Blood Establishments - 3,940, Transfusion Services - 1,932; Licensed Plasma Centers - 18,166

 

This chart shows the reporting time and the percentage of Biological Product Deviation Reports identified as potential recall situations submitted by Blood and Plasma establishments. Licensed Blood Establishments submitted 89% of their reports within 45 days of discovery, 8% of their reports between 45 and 90 days, and 4% of their reports greater than 90 days. Unlicensed Blood Establishments submitted 87% of their reports within 45 days of discovery, 3% between 45 and 90 days, and 4% of their reports greater than 90 days.  Licensed Plasma Centers submitted 55% of their reports within 45 days of discovery, 17% of their reports between 45 and 90 days, and 28% of their reports greater than 90 days.  Total number of reports identified as potential recall situations - 1,678; Licensed Blood establishments - 1,189; Unlicensed Blood establishments - 39; Plasma Centers - 450

Back to the Top


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

  • Licensed non-blood manufacturers submitted 116 more reports in FY09 than in the previous year (FY08-393) {Table 2}.
  • Vaccine manufacturers submitted 71 more reports (FY08-97)
    • The number of reports related to broken or cracked vials increased (FY08-18, FY09-78).
    • The number of reports related to the product not meeting specifications decreased from 32 in FY08 to 28 in FY09. There was a decrease in the number of reports related to specification for appearance not met, decreased (FY08-21, FY09-14)
  • Allergenic manufacturers submitted 23 more reports (FY08-169)
    • Of 181 product specification reports, 96% (173) of these reports were related to precipitate discovered in allergenic extracts, which was similar to the previous year (FY08-94%{152 product specification reports/161 total reports})
  • Blood Derivative manufacturers submitted 15 more reports (FY08-49)
    • The number of reports related to a failure in stability testing increased from 14 in FY08 to 20 in FY09
  • In Vitro Diagnostic manufacturers submitted five more reports (FY08-78)
    • The number of reports involving labeling decreased from 18 in FY08 to 8 in FY09
    • The number of reports related to equipment used in processing not performing properly increased from 4 in FY08 to 8 in FY09
    • The number of reports related to the product not meeting specifications increased from 15 in FY08 to 30 in FY09; most of these related to fill volume not met (FY08-1, FY09-16)
  • There were 13 fewer reports identified as potential recall situations (FY08-17)
  • There were a number of reports submitted that did not meet the reporting criteria.

Examples include the following situations:

  • There were no products distributed
  • The product affected by the deviation was not a U.S. licensed product
  • Incorrect number of lots submitted to CBER for surveillance testing, all lot release specifications met
  • A subsequent stability failure (e.g. at 12 months) was reported after the initial stability failure (e.g. at 6 months) was already reported

Total BPD Reports By Manufacturing System

Licensed Non-Blood

Table 32

Total BPD Reports By Manufacturing System Licensed Non-Blood Table 32
Manufacturing System

Allergenic

Blood Derivative

In Vitro Diagnostic

Vaccine

351 HCT/P

TOTAL

Product Specifications

181

35

38

43

0

297

58.3%

Quality Control & Distribution

2

4

11

84

0

101

19.8%

Process Controls

4

8

14

10

1

37

7.3%

Labeling

4

2

8

19

0

33

6.5%

Testing

0

8

7

4

1

20

3.9%

Incoming Material

1

7

4

5

0

17

3.3%

Miscellaneous

0

0

1

3

0

4

0.8%

Total

192

64

83

168

2

509

100%

Potential Recalls By Manufacturing System

Licensed Non-Blood

Table 33

Potential Recalls By Manufacturing System Licensed Non-Blood Table 33
Manufacturing System

Allergenic

Blood Derivative

In Vitro Diagnostic

Vaccine

TOTAL

Product Specifications

0

0

112

50.0%

Labeling

0

0

022

50.0%

Incoming Material

0

0

000

0.0%

Process Controls

0

0

000

0.0%

Testing

0

0

000

0.0%

Quality Control & Distribution

0

0

000

0.0%

Miscellaneous

0

0

000

0.0%

Total

0

0

134100.0%

A. Timeliness of BPD Reports

LICENSED NON-BLOOD MANUFACTURERS

Adherence To 45 Day Required Time For Reporting

(Reporting Time = Date of FDA receipt – Date of discovery of BPD)

Table 34

Adherence To 45 Day Required Time For Reporting
Reporting Time (days)

Allergenics

Blood Derivatives

In Vitro Diagnostics

Vaccines

351 HCT/P

Total

< or = 45

187

97%

55

86%

66

80%

111

66%

2

100%

421

83%

> 45 and <=90

4

2%

7

11%

17

20%

32

19%

0

0%

60

12%

> 90

1

1%

2

3%

0

0%

25

15%

0

0%

28

5%

Total

192

100%

64

100%

83

100%

168

100%

2

100%

509

100%

*Reporting time=0

13

 

0

 0 0     

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

 

This chart shows the reporting time and the number of total Biological Product Deviation Reports submitted by Licensed Non- Blood Manufacturers. Allergenic manufacturers submitted 187 reports within 45 days of discovery, 4 reports between 45 and 90 days, and 1 report greater than 90 days. Derivative manufacturers submitted 55 reports within 45 days of discovery, 7 reports between 45 and 90 days, and 2 reports greater than 90 days. In-Vitro Diagnostics manufacturers submitted 66 reports within 45 days of discovery and 17 reports between 45 and 90 days.  Vaccine manufacturers submitted 111 reports within 45 days of discovery, 32 reports between 45 and 90 days, and 25 reports greater than 90 days.  351 HCT/P manufacturers submitted 2 reports within 45 days of discovery.  Total number of reports - 509; Allergenic = 192; Derivative = 64; In-Vitro Diagnostics = 83; Vaccines = 168; 351 HCT/P = 2

 

This chart shows the reporting time and the number of total Biological Product Deviation Reports identified as potential recall situations submitted by Licensed Non- Blood Manufacturers.  In-Vitro Diagnostics manufacturers submitted 1 report between 45 and 90 days of discovery.  Vaccine manufacturers submitted 1 report within 45 days of discovery and 2 reports between 45 and 90 days of discovery.  Total number of reports identified as potential recall situations - 4; In-Vitro Diagnostics = 1; Vaccines = 3

 

Back to the Top


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 Par 1271became 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).

362 HCT/P manufacturers submitted 32 more reports in FY09 than in the previous year (FY08-222) {Table 2}.

  • Cellular HCT/Ps:
    • The number of reports involving processing and process controls increased from 50 in FY08 to 66 in FY09. There was an increase in reports of contamination or potential contamination during processing (FY08-47, FY09-59)
    • There was a decrease from the previous year, in the number of reports involving donor testing (FY08-42, FY09-4)
    • The number of reports involving r eceipt, pre-distribution, shipment and distribution increased from 33 in FY08 to 53 in FY09. There was an increase in reports of distribution of product that was contaminated or potentially contaminated (FY08-32, FY09-50)
  • Non-Cellular HCT/Ps:
    • The number of reports involving donor eligibility was the same as the previous year (FY08 and FY09 - 32). Of the 32 reports involving donor eligibility, 28 reports involved the acceptance of ineligible donors. 18 of these reports involved risk factors, clinical or physical evidence identified, 6 reports involved donor testing reactive for a relevant communicable disease, and 4 reports involved incorrectly evaluating donor for plasma dilution.
    • The number of reports involving processing and process controls increased from 18 in FY08 to 35 in FY09. There was an increase in reports involving contamination or potential contamination during processing (FY08-17, FY09-34).
    • The number of reports involving donor screening decreased from 15 in FY08 to 7 in FY09. There was a decrease in the number of reports in which the donor medical history interview performed incorrectly (FY08-13, FY09-5).

Non-Reportable Events

  • There were a number of reports submitted that did not meet the reporting criteria.

Examples include the following situations:

  • The event did not occur in the reporting establishment’s facility or in a facility that performed a manufacturing step for the reporting establishment
  • There were no products distributed
  • The HCT/P deviation affected an unlicensed product regulated under section 351 of the PHS Act (e.g., hematopoietic stem/progenitor cells collected from an unrelated allogeneic donor)
  • The event was not related to core current good tissue practices (CGTPs) (e.g., product not shipped at appropriate temperature)
  • The event did not meet the definition of HCT/P deviation because it was not related the prevention of communicable disease transmission or HCT/P contamination (e.g., donor had history of cancer)

Deviation Code (BPD Code) Selection

In some cases, the establishment selected the incorrect deviation code to capture the event. This may be due to incorrect data entry of the BPD Code, or selecting a less specific code when a more appropriate code is available. When the wrong code is used, our reviewers notify the reporter and enter the report into our database using the proper code. The most common errors in coding were:

  • Processing and Processing Controls (PC-01-01) vs. Receipt, Pre-Distribution, Shipment, and Distribution (SD-02-04)
    • If a product is distributed and subsequently found to be contaminated or potentially contaminated (i.e., positive culture result), the deviation code should be PC-01-01 (Processing and Processing Controls; Processing; HCT/P contaminated, potentially contaminated, or cross-contaminated during processing)
    • If a product is found to be contaminated or potentially contaminated (i.e., positive culture result) and the product is subsequently distributed, the deviation code should be SD-02-04 (Receipt, Pre-Distribution, Shipment, and Distribution; Inappropriate distribution; Contaminated or potentially contaminated HCT/P )

Total Reports By Manufacturing System

361 HCT/P

Table 35

Total Reports By Manufacturing System 361 HCT/P Table 35
HCT/P Deviation Code

Cellular HCT/P

Non-Cellular HCT/P

Total

Processing and Processing Controls66

35

101

39.8%

Receipt, Pre-Distribution, Shipment & Distribution53

5

58

22.8%

Donor Testing4

34

38

15.0%

Donor Eligibility2

32

34

13.4%

Recovery6

8

14

5.5%

Donor Screening0

7

7

2.8%

Labeling Controls0

2

2

0.8%

Supplies and Reagents0

0

0

0.0%

Environmental Control0

0

0

0.0%

Storage0

0

0

0.0%

Total131

123

254

100%

Potential Recalls By Manufacturing System

361 HCT/P

Table 36

Potential Recalls By Manufacturing System 361 HCT/P Table 36
HCT/P Deviation Code

Cellular HCT/P

Non-Cellular HCT/P

Total

Donor Eligibility1

15

16

48.5%

Donor Screening0

5

5

15.2%

Recovery0

4

4

12.1%

Donor Testing0

3

3

9.1%

Receipt, Pre-Distribution, Shipment & Distribution0

3

3

9.1%

Processing and Processing Controls0

1

1

3.0%

Labeling Controls0

1

1

3.0%

Environmental Control0

0

0

0.0%

Supplies and Reagents0

0

0

0.0%

Storage0

0

0

0.0%

Total1

32

33

100%

A. Timeliness of BPD Reports

361 HCT/P MANUFACTURERS

Adherence To 45 Day Required Time For Reporting

(Reporting Time = Date of FDA receipt – Date of discovery of BPD)

Table 37

Adherence To 45 Day Required Time For Reporting
Reporting Time (days)

Cellular

Non-Cellular

Total

< or = 4597

74%

111

90%

208

82%
> 45 and <=9025

19%

9

7%

34

13%
> 909

7%

3

2%

12

5%
Total131

100%

123

100%

254

100%
*Reporting time=00 

3

 

3

 

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

 

This chart shows the reporting time and the number of total HCT/P Deviation Reports submitted by 361 HCT/P Manufacturers. Celluar HCT/P  manufacturers submitted 97 reports within 45 days of discovery, 25 reports between 45 and 90 days, and 9 reports greater than 90 days. Non-cellular HCT/P manufacturers submitted 111 reports within 45 days of discovery, 9 reports between 45 and 90 days, and 3 reports greater than 90 days.   Total number of reports - 254; Cellular = 131; Non-Cellular = 123

 

This chart shows the reporting time and the number of total HCT/P Deviation Reports identified as potential recall situations submitted by 361 HCT/P Manufacturers. Celluar HCT/P  manufacturers submitted 1 report within 45 days of discovery. Non-cellular HCT/P manufacturers submitted 26 reports within 45 days of discovery, 5 reports between 45 and 90 days, and 1 report greater than 90 days.   Total number of reports - 33; Cellular = 1; Non-Cellular = 32

Back to the Top


V. Attachments

  1. Table-Number of BPD Reports by Type of Blood Establishments (PDF - 93 KB)
  2. List of BPD Codes for Blood and Plasma Establishments (PDF - 152 KB)
  3. Table-Number of BPDs by Type of Licensed Non-Blood Manufacturer (PDF - 62 KB)
  4. List of BPD Codes for Non-Blood Manufacturers (PDF - 30 KB)
  5. Table-Number of HCT/P Deviations by Type of 361 HCT/P Manufacturer (PDF - 27 KB)
  6. List of HCT/P Deviation Codes for 361 HCT/P Manufacturers (PDF - 30 KB)

VI. References

  1. Proposed Collection; Comment Request; Investigating the Causes of Post Donation Information (PDI): Errors in the Donor Screening Process. Federal Register, February 23, 2010, Volume 75 pages 8080-8081 (75 FR 8080) http://frwebgate5.access.gpo.gov/cgi-bin/TEXTgate.cgi?WAISdocID=50943982919+1+1+0&WAISaction=retrieve
  2. Lee, JL, Wilkinson, SL, et. al. An objective structured clinical examination to evaluate health historian competencies. Transfusion 2003; 43: 34-41
  3. Guidance for Industry - Biological Product Deviation Reporting for Blood and Plasma Establishments 10/18/2006 http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm073455.htm
  4. Shimian Zou, et.al. Prevalence, incidence, and residual risk of human immunodeficiency virus and hepatitis C virus infections among United States blood donors since the introduction of nucleic acid testing Published Online: Mar 12 2010 10:23AM http://dx.doi.org/10.1111/j.1537-2995.2010.02622.x
  5. Shimian Zou, Fatemeh Musavi, Edward P. Notari, Susan L. Stramer, Roger Y. Dodd. P revalence, incidence, and residual risk of major blood-borne infections among apheresis collections to the American Red Cross Blood Services, 2004 through 2008
    Published Online: Mar 12 2010 10:22AM http://dx.doi.org/10.1111/j.1537-2995.2010.02621.x
  6. R.Y. Dodd, E.P. Notari IV, and S.L. Stramer. Current prevalence and incidence of infectious disease markers and estimated window-period risk in the American Red Cross blood donor population. Transfusion 2002; 42: 975-979
  7. Guidance for Industry - Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components 10/18/2006 http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/General/ucm163893.htm

 

Back to the Top

Back to the Biological Product Deviation Reports Annual Summaries

Page Last Updated: 09/02/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.