II. BPD Reports Submitted By Blood And Plasma Establishments

Total BPDRs By Manufacturing System

Table 8

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

 Potential Recalls By Manufacturing System

Table 9

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

Post donation information (PDI) continues to be the most frequently reported event associated with the manufacturing of blood and plasma products. The most common PDI involved donors providing information concerning travel to malarial endemic areas and travel to an area at potential risk for vCJD. It is unclear why blood establishments are unable to elicit information during the first donor interview, but successfully elicit the information during a subsequent interview. Eliciting proper information regarding a donor candidate’s travel history is apparently the most problematic part of the donor qualification process.

We encourage blood establishments to review their donor screening processes to reduce the frequency of PDI reports. We also encourage those who implement successful strategies to share their information so that others may also fashion promising strategies to reduce PDI in their system.

FY08 Reports of Post Donation Information (PDI)

Table 10

Table 11

* 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

 A. Reporting Issues

In an effort to provide practical and useful information regarding reporting deviations, this section addresses non-reportable events, deviation code selection and product information entry.

Non-Reportable Events

Blood establishments submitted most of the non-reportable reports. The 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 donor's weight, age, donating within 56 days of last donation, or more than 24 pheresis donations within 12 months
• 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. Hospital staff errors are not associated with manufacturing.
• 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

Deviation Code (BPD Code) Selection

In some cases, the establishment selected the incorrect deviation code to capture the event. When the wrong code is used, our reviewers notify the reporter and enter using the proper code. The most common errors in coding 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, the event is a donor screening deviation.
• Routine Testing (RT) vs. Quality Control & Distribution (QC)
  • A patient had a history of an antibody and the blood bank did not screen the unit 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.
• 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
  • Do not use QC-97-13 to report an event associated with not issuing a product appropriately if another deviation code is more specific to the actual event
    • 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
• 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

Product Information

When blood establishments report deviations associated with the distribution of 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.

 B. Most Frequent BPD Reports Submitted by Licensed Blood Establishments 

Of the 26,655 reports submitted by licensed blood establishments, 19,656 (73.7%) reports involved post donation information.

• The number of these reports decreased by 14% (FY07-22,856)
• The number of reports in which a donor or third party provided subsequent information related to high risk behavior or history decreased by 11% (FY07-20,516)

The number of reports in which a donor or third party provided subsequent information related to post donation illness decreased by 40% (FY07-2,099)

A change in policy related to donors with a post donation diagnosis of cancer attributed to a portion of the decrease in the number of reports

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

Table 12

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

Of the 26,655 reports submitted by licensed blood establishments, 2,025 (7.6%) reports involved quality control and distribution deviations and unexpected events.

The number of these reports increased by 10% (FY07-1,837)

The number of reports involving the release of a product with unacceptable, undocumented, or incomplete product QC increased 18% (FY07-795)

There was an increase of 23% (FY07-502) 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 13

Of the 26,655 reports submitted by licensed blood establishments, 856 (3.2%) reports involved miscellaneous deviations and unexpected events.

• The number of these reports increased by 14% (FY07-748). FY07 had an increase by 33% from FY06 (563).
• The number of reports in which products were collected and distributed from a donor who subsequently tested confirmed positive increased by 16% (FY07-717). FY07 had an increase by 39% from FY06 (515).

Most Frequent BPD Reports – Miscellaneous From Licensed Blood Establishments

Table 15

Of the 26,655 reports submitted by licensed blood establishments, 816 (3.1%) reports involved labeling deviations and unexpected events.

• The number of these reports increased by 3% (FY07-790)
• The number of reports involving the labeling of the unit or product increased by 16% (FY07-396)
• The number of reports involving the labeling of the crossmatch tag or tie tag decreased by 16% (FY07-366)
• The number of reports involving the recipient identification labeling on the crossmatch tag or tie tag decreased by 24% (FY07-254)

Most Frequent BPD Reports - Labeling From Licensed Blood Establishments

Table 16

C. Most Frequent BPD Reports Submitted by Unlicensed Blood Establishments

Of the 3,798 reports submitted by unlicensed blood establishments, 1,798 (47.3%) involved quality control and distribution deviations and unexpected events.

• The number and distribution of these reports was similar to the reports received in the previous fiscal year (FY07-1,762)
• The number of reports involving distribution procedures not performed in accordance with the blood bank transfusion service’s specifications increased by 7% (FY07-1215)
  • The number of reports involving the release of a product that was not documented or incorrectly documented as issued in the computer increased by 14% (FY07-548)

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

Table 17

Of the 3,798 reports submitted by unlicensed blood establishments, 948 (25%) involved labeling deviations and unexpected events.

• The number of these reports was similar to the reports received in the previous fiscal year (FY07-950)
• The number of reports involving labeling of the unit decreased by 9% (FY07-286)
• The number of reports involving labeling of the crossmatch tag or tie tag, increased by 12% (FY07-452)
• The number of reports involving labeling of the transfusion record decreased by 17% (FY07-212)

Most Frequent BPD Reports - Labeling From Unlicensed Blood Establishments 

Table 18

Of the 3,798 reports submitted by unlicensed blood establishments, 444 (11.7%) reports involved routine testing deviations and unexpected events.

• The number and distribution of these reports was similar to the reports received in the previous fiscal year (FY07-221)

Most Frequent BPD Reports - Routine Testing From Unlicensed Blood Establishments 

Table 20

Of the 3,798 reports submitted by unlicensed blood establishments, 389 (10.2%) reports involved post donation information.

• The number of these reports decreased by 25% (FY07-519)
• The number of reports in which a donor or third party provided subsequent information related to high risk behavior or history decreased by 24% (FY07-462)
  • The number of reports in which a donor or third party provided subsequent information regarding travel to a malarial or vCJD risk area decreased by 22% (FY07-276)
  • A change in policy related to donors with a history of cancer attributed to a portion of the decrease in the number of reports
• The number of reports in which a donor or third party provided subsequent information related to post donation illness decreased by 37% (FY07-51).
  • A change in policy related to donors with a post donation diagnosis of cancer attributed to a portion of the decrease in the number of reports

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

Table 19

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

 D. Most Frequent BPD Reports Submitted by Transfusion Services 

Of the 1,858 reports submitted by transfusion services, 993 (53.4%) reports involved quality control and distribution deviations and unexpected events.

• The number of these reports increased by 12% (FY07-890)
• The number of reports involving the release of a product that was not documented or incorrectly documented as issued in the computer increased by 16% (FY07-299)

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

Table 21

Of the 1,858 reports submitted by transfusion services, 519 (27.9%) reports involved labeling deviations and unexpected events.

• The number of these reports decreased by 8% (FY07-564)
• The number of reports involving the labeling of the product decreased from 141 in FY07 to 67 in FY08. The majority of these involved products that were missing a machine-readable label. On February 26, 2004 we published a final rule {21 CFR 606.121(c) (13)} entitled: “Bar Code Label Requirement for Human Drug Products and Biological Products”. Products subject to this rule were required to comply with this rule by April 26, 2006. (FY07-107; FY08-4)
• The number of reports involving the labeling of the crossmatch or tie tag increased from 270 in FY07 to 299 in FY08

Most Frequent BPD Reports - Labeling From Transfusion Services

Table 22

Of the 1,858 reports submitted by transfusion services, 338 (18.2%) reports involved routine testing deviations and unexpected events.

• The number and distribution of these reports was similar to the reports received in the previous fiscal year (FY07-338)

Most Frequent BPD Reports - Routine Testing From Transfusion Services

Table 23

E. Most Frequent BPD Reports Submitted by Licensed Plasma Centers 

Of the 11,814 reports submitted by licensed plasma centers, 10,107 (85.6%) involved post donation information.

• The number of these reports increased by 51% (FY07-6,658)
• The number of reports in which a donor or third party provided subsequent information related to high risk behavior or history increased by 51% (FY07-6,438)
  • The number of post donation information reports in which the donor had a history of a tattoo and/or piercing increased by 60% (FY07-4,528)
  • The number of post donation information reports in which the donor had a history of incarceration increased 24% (FY07-551)
• The number of reports in which a donor or third party provided subsequent information related to testing doubled (FY07-174)
  • The number of reports in which the donor tested positive, specific testing unknown, by another facility increased from 94 in FY07 to 235 in FY08

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

Table 24

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

Of the 11,814 reports submitted by licensed plasma centers, 1,038 (8.8%) reports involved miscellaneous deviations and unexpected events.

• The number of these reports increased by 60% (FY07-646)
• The number of reports in which products were collected and distributed from a donor who subsequently tested confirmed positive for HCV increased from 393 in FY07 to 579 in FY08
• The number of reports in which products were collected and distributed from a donor who subsequently tested confirmed positive for HBV increased from 171 in FY07 to 324 in FY08
• The number of reports in which products were collected and distributed from a donor who subsequently tested confirmed positive for HIV increased from 81 in FY07 to 126 in FY08

Most Frequent BPD Reports - Miscellaneous From LicensedPlasma Centers 

Table 25

Of the 11,814 reports submitted by licensed plasma centers, 508 (4.3%) reports involved donor screening deviations and unexpected events.

• The number of these reports increased by 43% (FY07-356)
• The number of reports in which the donor record was incomplete or incorrect increased from by 57% (FY07-118)
• The number of reports related to donor history questions increased by 73% (FY07-71)
• The number of reports in which the donor did not meet acceptance criteria increased by 14% (FY07-160)
  • The majority of these involve the medical review or physical not performed or inadequate decreased by 25% (FY07-102)
  • The number of reports related the donor temperature unacceptable or not documented doubled (FY07-46)

Most Frequent BPD Reports - Donor Screening From LicensedPlasma Centers 

Table 26

 F. 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 27

*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 Banks submitted 95% of their reports within 45 days of discovery, 3% of their reports between 45 and 90 days, and 2% of their reports greater than 90 days. Unlicensed Blood Banks submitted 83% of their reports within 45 days of discovery, 11% between 45 and 90 days, and 6% greater than 90 days. Transfusion Services submitted 85% of their reports within 45 days of discovery, 10% their reports between 45 and 90 days, and 5% of their reports greater than 90 days. Plasma Centers submitted 84% of their reports within 45 days of discovery, 11% of their reports between 45 and 90 days, and 5% of their reports greater than 90 days. Total number of reports - 44,124; Licensed Blood establishments - 26,655; Unlicensed Blood establishments - 3,798, Transfusion Services - 1,857; Plasma Centers - 11,814

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 Banks submitted 87% of their reports within 45 days of discovery, 8% of their reports between 45 and 90 days, and 5% of their reports greater than 90 days. Unlicensed Blood Banks submitted 97% of their reports within 45 days of discovery, and 3% between 45 and 90 days. Plasma Centers submitted 66% of their reports within 45 days of discovery, 22% of their reports between 45 and 90 days, and 12% of their reports greater than 90 days. Total number of reports identified as potential recall situations - 2,399; Licensed Blood establishments - 1,928; Unlicensed Blood establishments - 33; Plasma Centers - 438