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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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II. BPD Reports Submitted By Blood And Plasma Establishments

Total BPDRs By Manufacturing System

Table 8

 Manufacturing System

Licensed Establishments

Unlicensed Establishments

Transfusion Services

Licensed Plasma Centers

Total

DS-Post Donation Information

19,656

389

NA

10,107

30,152

68.3%

QC & Distribution

2,025

1,798

993

121

4,937

11.2%

DS-Donor Screening

1,698

84

NA

508

2,290

5.2%

Labeling

816

948

519

5

2,288

5.2%

Miscellaneous

856

20

0

1,038

1,914

4.3%

LT-Routine Testing

320

444

338

2

1,104

2.5%

Blood Collection

724

43

NA

9

776

1.8%

Component Preparation

404

67

8

4

483

1.1%

DS-Donor Deferral

116

3

NA

18

137

0.3%

LT-Viral Testing

40

2

NA

2

44

0.1%

Total

26,655

3,798

1,858

11,814

44,125

100%

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

 Potential Recalls By Manufacturing System

Table 9

Manufacturing System

Licensed Establishments

Unlicensed Establishments

Transfusion Services

Licensed Plasma Centers

Total

DS-Donor Screening

830

19

NA

333

1,182

49.3%

QC & Distribution

591

6

0

60

657

27.4%

Blood Collection

135

0

NA

3

138

5.8%

Component Preparation

110

2

0

3

115

4.8%

DS-Donor Deferral

79

0

NA

14

93

3.9%

Labeling

78

6

0

1

85

3.5%

DS-Post Donation Information

57

0

NA

22

79

3.3%

LT-Viral Testing

25

0

NA

2

27

1.1%

LT-Routine Testing

23

0

0

 0

23

1.0%

Total

1,928

33

0

438

2,399

100%

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

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

PDI OBTAINED THROUGH:

LICENSED ESTABLISHMENTS

UNLICENSED ESTABLISHMENTS

LICENSED PLASMA CENTERS

TOTAL

Subsequent Donation

18,038

368

7,476

25,882

85.8%

Telephone Call from Donor

918

12

27

957

3.2%

Third Party (e.g., doctor, family)

516

7

2,604

3,127

10.4%

Telerecruitment

184

2

0

186

0.6%

Total

19,656

389

10,107

30,152

100%

Table 11

THE PDI WAS:

LICENSED ESTABLISHMENTS

UNLICENSED ESTABLISHMENTS

LICENSED PLASMA CENTERS

TOTAL

Known, but not Provided at Time of Donation*

18,137

347

9,410

27,894

92.5%

Not Known at Time of Donation**

1,519

42

697

2,258

7.5%

Total

19,656

389

10,107

30,152

100%

* 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 regarding travel to a malaria risk area decreased by 6% (FY07-7,513)
  • The number of reports in which a donor or third party provided subsequent information regarding travel to a vCJD risk area decreased by 4% (FY07-3,973)
  • 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 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

POST DONATION INFORMATION (PD) 19,656

# Reports

% of Total (PD)

 Behavior/History

 18,182 

 92.5% 

Travel to malaria endemic area/history of malaria

7,075

36.0%

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

3,795

19.3%

Donor received tattoo

967

4.9%

Male donor had sex with another man

818

4.2%

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

659

3.4%

IV drug use

505

2.6%

 Illness

 1,261 

 6.4% 

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

1,184

6.0%

Post donation diagnosis or symptoms of Hepatitis B

16

0.1%

Post donation diagnosis or symptoms of sexually transmitted disease

14

0.1%

Post donation diagnosis or symptoms of Hepatitis A

14

0.1%

 Testing *

 146 

 0.7% 

Tested reactive for HIV post donation

29

0.1%

Tested reactive for HIV prior to donation

23

0.1%

 Not specifically related to high risk behavior

 67 

 0.3% 

Donated to be tested or called back for test results

49

0.2%

Donor does not want their blood used

18

0.1%

*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

QC & DISTRIBUTION (QC) 2,025

# Reports

% of Total (QC)

 Distribution of product that did not meet specifications

 1,480 

 73.1% 

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

938

46.3%

Bacterial detection testing61630.4%
Platelet count1396.9%
White Blood Cell count552.7%
Product in which instrument QC or validation was unacceptable, incomplete, not performed, or not documented

165

8.1%

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

82

4.0%

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

70

3.5%

 Shipping and storage

 260 

 12.8% 

Product not packaged in accordance with specifications

76

3.8%

No documentation that product was shipped or stored at appropriate temperature

60

3.0%

Product arrived at consignee at unacceptable temperature

32

1.6%

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

 143 

 7.1% 

Product not irradiated as required

30

1.5%

Product not documented or incorrectly documented as issued in the computer

32

1.6%

Product not leukoreduced as required

17

0.8%

 Testing not performed, incompletely performed, or not documented

 73 

3.6%

Antibody screen or identification

12

0.6%

Antigen screen

11

0.5%

 Failure to quarantine unit due to medical history:

 37 

 1.8% 

Post donation illness

21

1.0%

 Positive testing

 32 

 1.6% 

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

MISCELLANEOUS (MI) 856

# Reports

% of Total (MI)

 Lookback; subsequent unit tested confirmed positive for:

 832 

 97.2% 

HCV

398

46.5%

HIV

149

17.4%

HBV

138

16.1%

2x Anti-HBc positive475.5%
Chagas

81

9.5%

West Nile Virus

30

3.5%

HTLV

20

2.3%

Babesia

15

1.8%

 Donor implicated in transfusion associated disease

 23 

 2.7% 

Babesia

12

1.4%


 

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

LABELING (LA) 816

#Reports

% of Total (LA)

 Labels applied to blood unit or product incorrect or missing information

 460 

 56.4% 

Product or anticoagulant volume or weight incorrect or missing

107

13.1%

Extended expiration date or time

77

9.4%

Donor number or lot number incorrect or missing

59

7.2%

Product type or code incorrect

54

6.6%

ABO and/or Rh incorrect

33

4.0%

 Crossmatch tag or tie tag labels incorrect or missing information

 320 

 39.2% 

Recipient identification incorrect or missing

193

23.7%

Autologous unit759.2%
Antigen incorrect or missing

22

2.7%

Unit, lot, or pool number incorrect or missing

11

1.3%

Crossmatch tag switched, both units intended for the same patient

10

1.2%

 Transfusion record (crossmatch slip) incorrect or missing information

 29 

 3.6% 

Unit, lot or pool number incorrect or missing

5

0.6%



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

QC & DISTRIBUTION (QC) 1,798

# Reports

% of Total (QC)

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

 1,300 

 72.3% 

Product not documented or incorrectly documented as issued in the computer

627

34.9%

Product not irradiated as required

188

10.5%

Improper product selected for patient

102

5.7%

Improper ABO or Rh type selected for patient

78

4.3%

Product issued to wrong patient

59

3.3%

 Testing not performed, incompletely performed, or not documented

 302 

 16.8% 

Antibody screen or identification

91

5.1%

Antigen screen

62

3.4%

Compatibility

48

2.7%

 Distribution of product that did not meet specifications::

 159 

 8.8% 

Product QC unacceptable, not performed, not documented or incomplete

85

4.7%

Bacterial detection testing532.9%
Outdated product

29

1.6%

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

29

1.6%

 Shipping and storage

 34 

 1.9% 

No documentation that product was shipped or stored at appropriate temperature

19

1.1%

Stored at incorrect temperature

9

0.5%

Temperature not recorded or unacceptable upon return, unit redistributed

3

0.2%

Product not packed in accordance with specifications

3

0.2%

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

LABELING (LA) 948

#Reports

% of Total (LA)

 Crossmatch tag or tie tag labels incorrect or missing information

 505 

 53.3% 

Recipient identification incorrect or missing

137

14.5%

Autologous unit10.1%
Unit, lot, or pool number incorrect or missing

103

10.9%

Crossmatch tag switched, both units intended for the same patient

98

10.3%

 Labels applied to blood unit or product incorrect or missing information

 265 

 28.0% 

Extended expiration date or time

104

11.0%

Donor number or lot number incorrect or missing

33

3.5%

ABO and/or Rh incorrect

28

3.0%

Product type or code incorrect

25

2.6%

 Transfusion record (crossmatch slip) incorrect or missing information

 177 

 18.7% 

Transfusion record switched, both units intended for the same patient

50

5.3%

Unit, lot, or pool number incorrect or missing

32

3.4%

Recipient identification incorrect or missing

32

3.4%

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

ROUTINE TESTING (RT) 444

# Reports

% of Total (RT)

 Testing performed, interpreted, or documented incorrectly

 237 

 53.4% 

Antibody screening or identification

63

14.2%

Compatibility

80

18.0%

Immediate spin performed instead of full crossmatch5211.7%
Electronic performed instead of full crossmatch102.3%
Antigen typing

49

11.0%

 Sample (used for testing) identification

 118 

 26.6% 

Sample used for testing was incorrectly or incompletely labeled

96

21.6%

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

10

2.3%

Incorrect sample tested

9

2.0%

 Reagent QC unacceptable or expired reagents used

 89 

 20.0% 

Antibody screening or identification

26

5.9%

Multiple testing

14

3.2%

Coombs control cells

13

2.9%


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

POST DONATION INFORMATION (PD) 389

# Reports

% of Total (PD)

 Behavior/History

 350 

 89.0% 

Travel to malaria endemic area/history of malaria

141

35.8%

Risk factors associated with vCJD – travel

73

17.3%

Donor received tissue allograft or transplanted organ

12

6.9%

Donor received tattoo

11

2.5%

 Illness

 32 

 9.8% 

 Testing*

 5 

 1.0% 

*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

QC & DISTRIBUTION (QC) 993

# Reports

% of Total (QC)

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

 728 

 73.3% 

Product not documented or incorrectly documented as issued in the computer

347

34.9%

Product not irradiated as required

64

6.4%

Procedure for issuing not performed or documented in accordance with specifications

62

6.2%

Improper ABO or Rh type selected for patient

57

5.7%

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

34

3.4%

Product issued to the wrong patient

33

3.3%

Improper product selected for patient

28

2.8%

Product not leukoreduced as required

20

2.0%

 Testing not performed, incompletely performed, or not documented

 191 

 19.2% 

Antibody screen or identification

55

5.5%

Antigen screen

45

4.5%

ABO and Rh

41

4.1%

 Distribution of product that did not meet specifications:

 42 

 4.2% 

Outdated product

25

2.5%

Product QC unacceptable, not performed, not documented or incomplete

7

0.7%

 Shipping and storage

 30 

 3.0% 

Stored at incorrect temperature

15

1.5%

No documentation that product was shipped or stored at appropriate temperature

7

0.7%

Product not packed in accordance with specifications

5

0.5%

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

LABELING (LA) 519

# Reports

% of Total (LA)

 Crossmatch tag or tie tag labels incorrect or missing information

 299 

 57.6% 

Recipient identification incorrect or missing

90

17.3%

Unit, lot, or pool number incorrect or missing

61

11.8%

Crossmatch tag switched, both units intended for the same patient

58

11.2%

Product type incorrect or missing

17

3.3%

Crossmatch tag or tie tag missing or attached to incorrect unit

17

3.3%

 Transfusion record (crossmatch slip) incorrect or missing information

 153 

 29.5% 

Transfusion records switched, both units intended for the same patient

35

6.7%

Recipient identification incorrect or missing

31

6.0%

Unit, lot, or pool number incorrect or missing

23

4.4%

Unit ABO and/or Rh incorrect or missing

12

2.3%

 Labels applied to blood unit or product incorrect or missing information

 67 

 12.9% 

Extended expiration date or time

26

5.0%

Donor number or lot number incorrect or missing

14

2.7%

ABO and/or Rh incorrect

6

1.2%

Product type or code incorrect

6

1.2%

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

ROUTINE TESTING (RT) 338

# Reports

% of Total (RT)

 Testing performed, interpreted, or documented incorrectly

 191 

 56.5% 

Antibody screening or identification

58

17.2%

Compatibility

52

15.4%

Immediate spin performed instead of full crossmatch4011.8%
Antigen typing

31

9.2%

Rh typing

25

7.4%

 Sample (used for testing) identification

 86 

 25.4% 

Sample used for testing was incorrectly or incompletely labeled

58

17.2%

Unsuitable sample used for testing

16

4.7%

Incorrect sample tested

9

2.7%

 Reagent QC unacceptable or expired reagents used

 61 

 18.0% 

Antibody screening or identification

20

5.9%

Multiple testing

14

4.1%

ABO

9

2.7%



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

POST DONATION INFORMATION (PD) 10,107

# Reports

% of Total (PD)

 Behavior/History

 9,730 

 96.3% 

Donor received tattoo

4,909

48.6%

Donor received body piercing

1,554

15.4%

Incarcerated

685

6.8%

Donor received ear piercing

429

4.2%

Non-sexual exposure to Hepatitis C

394

3.9%

Donor received tattoo and piercing

348

3.4%

Risk factors associated with vCJD – travel

262

2.6%

IV drug use

204

2.0%

 Testing *

 349 

 3.5% 

Tested reactive at another center, specific testing unknown

235

2.3%

Tested reactive for HCV post donation

60

0.6%

Tested reactive for HIV post donation

30

0.3%

Tested reactive for HBV post donation

18

0.2%

 Illness

 28 

 0.3% 

*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

MISCELLANEOUS (MI) 1,038

# Reports

% of Total (MI)

 Lookback; subsequent unit tested confirmed positive for:

 1,038 

 100% 

HCV

579

55.8%

HBV

324

31.2%

HIV

126

12.1%


 

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

DONOR SCREENING (DS) 508

# Reports

% of Total (DS)

 Donor record incomplete or incorrect

 185 

 33.1% 

Donor history questions

123

24.2%

Donor identification

37

7.3%

Arm inspection

13

2.6%

 Donor did not meet acceptance criteria

 183 

 36.0% 

Temperature unacceptable or not documented

95

18.7%

Medical review or physical not performed or inadequate

76

15.0%

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

 97 

 19.1% 

Donor received tattoo

40

7.9%

Donor received ear/body piercing

16

3.1%

Risk factors associated with vCJD - travel

5

1.0%

Donor received tattoo and piercing

5

1.0%

Multiple high risk behaviors/contacts

5

1.0%

 Deferral screening not done or incorrectly performed

 38 

 7.5% 

Donor previously deferred due to history

30

5.9%

Donor received tattoo51.0%
Incarcerated40.8%
Donor previously deferred due to testing

6

1.2%

 Incorrect ID used during deferral search

 5 

 1.0% 

Donor previously deferred due to history

3

0.6%

Donor previously deferred due to testing

2

0.4%


 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 (days)

Licensed Establishments

Unlicensed Establishments

Transfusion Services

Plasma Centers

Total

< or = 45

25,302

95%

3,156

83%

1,575

85%

9,886

84%

39,919

90%

> 45 and <=90

890

3%

409

11%

186

10%

1313

11%

2,798

6%

> 90

463

2%

233

6%

96

5%

615

5%

1,407

3%

Total

26,655

100%

3,798

100%

1857**

100%

11,814

100%

44,124

100%

*Reporting time=0

26

 

67

 

86

 

2

 

181

 

*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

Biological Product Deviation Reports Blood and Plasma Establishments Reporting Time - Total Reports

 

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

 

Biological Product Deviation Reports Blood and Plasma Establishments Reporting Time - Potential Recalls