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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Annual Summary for Fiscal Year 2010

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 Biological Product and HCT/P Deviation Report

Table of Contents

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

Back to the Biological Product Deviation Reports Annual Summaries


I. Executive Summary:

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

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

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

  • We received more than 51,012 reports, but this summary does not capture data for reports that did not meet the reporting threshold. We notified the reporter when a report was not required.
  • There was a 2% (730 reports) increase in the number of reports received in FY10 compared to FY09 {Table 2}
    • We received 2% more reports from blood and plasma establishments in FY10 compared to FY09 {Table 2}
      • We received 3% fewer reports from licensed blood establishments in FY10 compared to FY09 {Table 2}
      • We received 2% fewer reports from unlicensed registered blood establishments in FY10 compared to FY09 {Table 2}
      • We received 9% fewer reports from transfusion services in FY10 compared to FY09 {Table 2}
      • We received 11% more reports from licensed plasma centers in FY10 compared to FY09 {Table 2}
    • We received 30% more reports from manufacturers of licensed biological products other than blood and blood components in FY10 compared to FY09 {Table 2}
      • Vaccine manufacturers submitted 74 more reports in FY10
      • Blood Derivative manufacturers submitted 35 more reports in FY10
      • In-vitro diagnostic manufacturers submitted 34 more reports in FY10
      • Allergenic manufacturers submitted five more reports in FY10
      • Licensed HCT/P manufacturers (351 HCT/P) submitted four more reports in FY10
    • We received 32 more reports from 361 HCT/P manufacturers in FY10 compared to FY09 {Table 2}
      • Cellular HCT/P manufacturers submitted 29 more reports in FY10
      • Non-cellular HCT/P manufacturers submitted three more reports in FY1
  • The number of reporting establishments increased by four in FY10 compared to FY09 {Table 2}
    • Compared to FY09, there were 12 more unlicensed blood establishments, 30 fewer transfusion services and 18 more licensed plasma centers reporting in FY10
    • Compared to FY09, there were 6 more manufacturers of licensed biological products other than blood and blood components reporting in FY10
    • Compared to FY09, there 5 fewer 361 HCT/P manufacturers reporting in FY10

You may submit questions concerning this summary to:

FDA/Center for Biologics Evaluation and Research
Office of Compliance and Biologics Quality
Division of Inspections and Surveillance (HFM-650)
1401 Rockville Pike, Suite 200 North
Rockville , Maryland 20852-1448

You may also contact us by email at bp_deviations@fda.hhs.gov, hctp_deviations@fda.hhs.gov, or sharon.ocallaghan@fda.hhs.gov (Sharon O’Callaghan) or by phone at 301-827-6220.

Total Deviation Reports FY10

Table 1

 

Number Of Reporting Establishments

Total Reports Received

Potential Recalls

Blood/Plasma Manufacturers

 

 

 

 

Licensed Blood Establishments

250(113*)

24,282

838

3.5%

Unlicensed Blood Establishments 1

425

3,850

27

0.7%

Transfusion Services 2

545

1,760

0

0.0%

Licensed Plasma Centers

392(48*)

20,173

291

1.4%

Sub-Total

1,611

50,065

1,156

2.3%

Licensed Non-Blood Manufacturers

 

 

 

 

Allergenic

7

197

4

2.0%

Blood Derivative

23

99

0

0.0%

In Vitro Diagnostic

14

117

12

10.2%

Vaccine

17

242

8

3.3%

351 HCT/P

2

6

0

0.0%

Sub-Total

63

661

24

3.6%

361 HCT/P Manufacturers

 

 

 

 

Cellular HCT/P

43

160

1

0.6%

Non-Cellular HCT/P

32

126

28

22.2%

Sub-Total

75

286

29

10.1%

Total

1,749

51,012

1,209

2.4%

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

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

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

Total Deviation Reports FY08 – FY10

Table 2

 

Number Of Reporting Establishments

Total Reports Received

Potential Recalls

Blood/Plasma Manufacturers

FY08

FY09

FY10

FY08

FY09

FY10

FY08

FY09

FY10

Licensed Blood Establishments

247(120*)

246( 113*)

250(113*)

26,655

25,481

24,282

1,928

1,189

838

Unlicensed Blood Establishments

417

413

425

3,798

3,940

3,850

33

39

27

Transfusion Services

541

575

545

1,858

1,932

1,760

0

0

0

Licensed Plasma Centers

328( 43*)

374( 53*)

392(48*)

11,814

18,168

20,173

438

450

291

Sub-Total

1,544

1,609

1,611

44,125

49,521

50,065

2,399

1,678

1,156

Licensed Non-Blood Manufacturers

 

 

 

 

 

 

 

 

 

Allergenic

7

8

7

169

192

197

2

0

4

Blood Derivative

17

19

23

49

64

99

7

0

0

In Vitro Diagnostic

8

11

14

77

83

117

7

1

12

Vaccine

15

18

17

98

168

242

1

3

8

351 HCT/P

0

1

2

0

2

6

0

0

0

Sub-Total

47

57

63

393

509

661

17

4

24

361 HCT/P Manufacturers

 

 

 

 

 

 

 

 

 

Cellular HCT/P

48

40

43

140

131

160

2

1

1

Non-Cellular HCT/P

36

40

32

82

123

126

38

32

28

Sub-Total

84

80

75

222

254

286

40

33

29

Total

1,675

1,745

1,749

44,740

50,282

51,012

2,456

1,715

1,209

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

Blood & Plasma BPD Reports By Manufacturing System FY08 – FY10

Table 3

Manufacturing System

FY08

FY09

FY10

Donor Suitability

32,579

73.8%

37,620

76.0%

39,267

78.4%

Post Donation Information

30,152

68.3%

34,844

70.4%

36,267

72.4%

Donor Screening

2,290

5.2%

2,726

5.5%

2,758

5.5%

Donor Deferral

137

0.3%

50

0.1%

197

0.4%

QC & Distribution

4,937

11.2%

4,837

9.8%

4,289

8.6%

Labeling

2,288

5.2%

2,261

4.6%

2,118

4.2%

Miscellaneous

1,914

4.3%

2,261

4.6%

2,074

4.1%

Laboratory Testing

1,148

2.6%

1,040

2.1%

1,019

2.0%

Routine Testing

1,104

2.5%

998

2.0%

1,007

2.0%

Viral Testing

44

0.1%

42

0.1%

12

0.0%

Collection

776

1.8%

996

2.0%

1,019

2.0%

Component Preparation

483

1.1%

506

1.0%

324

0.6%

Total

44,125

100%

49,521

100%

50,065

100%

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

Table 4

Manufacturing System

Allergenic

Blood Derivative

In Vitro Diagnostic

 

FY08

FY09

FY10

FY08

FY09

FY10

FY08

FY09

FY10

Product Specifications

161

181

179

18

35

25

28

38

52

Quality Control & Distribution

0

2

2

5

4

9

14

11

31

Process Controls

4

4

9

8

8

35

9

14

6

Labeling

4

4

7

4

2

4

18

8

14

Incoming Material

0

1

0

3

7

15

2

4

4

Testing

0

0

0

8

8

9

7

7

9

Miscellaneous

0

0

0

3

0

2

0

1

1

Total

169

192

197

49

64

99

78

83

117

Table 4 (continued)

Manufacturing System

Vaccine

351 HCT/P

Total

 

FY08

FY09

FY10

FY08

FY09

FY10

FY08

FY09

FY10

Product Specifications

50

43

91

0

0

2

257

297

349

Quality Control & Distribution

20

84

93

0

0

1

39

101

136

Process Controls

9

10

13

0

1

0

30

37

63

Labeling

7

19

16

0

0

1

33

33

42

Incoming Material

1

5

11

0

0

2

6

17

32

Testing

7

4

14

0

1

0

22

20

32

Miscellaneous

3

3

4

0

0

0

6

4

7

Total

97

168

242

0

2

6

393

509

661

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

 Table 5

Manufacturing System

Cellular HCT/Ps

Non-Cellular HCT/Ps

Total

 

FY08

FY09

FY10

FY08

FY09

FY10

FY08

FY09

FY10

Donor Testing

42

4

27

12

34

56

54

38

83

Processing & Processing Controls

50

66

64

18

35

17

68

101

81

Receipt, Pre-Distrib., Shipment & Distrib.

33

53

53

3

5

4

36

58

57

Donor Eligibility

4

2

3

33

32

23

36

34

26

Donor Screening

2

0

1

15

7

20

17

7

21

Recovery

8

6

9

0

8

0

8

14

9

Supplies and Reagents

1

0

0

0

0

4

1

0

4

Environmental Control

0

0

1

0

0

1

0

0

2

Labeling Controls

0

0

1

2

2

1

2

2

2

Storage

0

0

1

0

0

0

0

0

1

Total

140

131

160

83

123

126

222

254

286

Back to the Top


II. BPD Reports Submitted By Blood and Plasma Establishments:

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

Table 6

 Manufacturing System

Licensed Blood Establishments

Unlicensed Blood Establishments

Transfusion Services

Licensed Plasma Centers

Total

 

DS-Post Donation Information

17,807

422

NA

18,038

36,267

72.4%

QC & Distribution

1,421

1,764

986

118

4,289

8.6%

DS-Donor Screening

2,052

84

NA

622

2,758

5.5%

Labeling

615

1,022

466

15

2,118

4.2%

Miscellaneous

691

21

NA

1,362

2,074

4.1%

Blood Collection

971

40

NA

8

1,019

2.0%

LT-Routine Testing

293

410

304

0

1,007

2.0%

Component Preparation

238

80

4

2

324

0.7%

DS-Donor Deferral

183

6

NA

8

197

0.4%

LT-Viral Testing

11

1

NA

0

12

0.0%

Total

24,282

3,850

1,760

20,173

50,065

100%

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

Post Donation Information

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

  •  Licensed plasma centers submitted 2,167 more reports in FY10 compared to FY09 involving post donation information. Most of these reports involved donors who had a history of tattoo and/or piercing or a history of incarceration.
  • Blood establishments submitted 743 fewer reports in FY10 compared to FY09 involving post donation information. They submitted 488 fewer reports involving travel to malarial endemic areas or variant Creutzfeldt-Jakob Disease (vCJD) risk areas.
Table 7 illustrates the major differences in post donation information reports from FY09 to FY10. It does not include all post donation information reports.

PDI Reports Submitted by Blood and Plasma Establishments

Table 7

Blood Establishments

FY08

FY09

FY10

 Post Donation Information (PD) - total

20,045

18,972

18,229

Donor had a history of travel to malarial risk area

7,216

6,654

6,553

Donor had a history of travel to vCJD risk area

3,871

3,683

3,296

Donor received tattoo and/or piercing

1,290

1,431

1,466

Post donation illness

1,213

1,029

967

Donor had male/male sex

833

868

810

 

Licensed Plasma Centers

FY08

FY09

FY10

Post Donation Information (PD) - total

10,107

15,871

18,038

Donor received tattoo and/or piercing

7,240

11,731

13,155

Donor had a history of incarceration

685

1,008

1,126

Miscellaneous

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

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

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

Viral Maker Lookback Reports Submitted by Blood and Plasma Establishments

Table 8

 Blood Establishments

FY06

FY07

FY08

FY09

FY10

Lookback; Subsequent unit confirmed positive (MI02) - total

510

721

852

874

687

HCV (MI0204)

309

315

405

527

377

HIV (MI0202)

88

120

152

133

167

HBV (MI0203)

96

163

140

127

93

 

Licensed Plasma Centers 

FY06

FY07

FY08

FY09

FY10

Lookback; Subsequent unit confirmed positive (MI02) - total

98

646

1,038

1,363

1,362

HCV (MI0204)

63

393

579

814

725

HBV (MI0203)

23

171

324

401

461

HIV (MI0202)

13

81

129

146

172

A. Most Frequent BPD Reports Submitted by Licensed Blood Establishments

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

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

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

Table 9

POST DONATION INFORMATION (PD) 17,807

# Reports

% of Total (PD)

Behavior/History

16,437

92.3%

Travel to malaria endemic area/history of malaria

6,389

35.9%

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

3,208

18.0%

Donor received tattoo and/or piercing

1,444

8.1%

Male donor had sex with another man

794

4.5%

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

614

3.4%

Donor received tissue allograft or transplanted organ

464

2.6%

IV drug use

416

2.3%

Illness

1,008

5.7%

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

948

5.3%

Post donation diagnosis or symptoms of Hepatitis C

15

0.1%

Post donation diagnosis or symptoms of HIV

13

0.1%

Testing *

299

1.7%

Tested reactive for HIV prior to donation

68

0.4%

Tested reactive for Hepatitis B prior to donation

54

0.3%

Tested reactive for Hepatitis C prior to donation

51

0.3%

Tested reactive for HIV post donation

27

0.2%

Tested reactive for HTLV prior to donation

25

0.1%

Not specifically related to high risk behavior

63

0.4%

Donated to be tested or called back for test results

37

0.2%

Donor does not want their blood used

26

0.1%

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

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

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

Most Frequent BPD Reports – Donor Screening From Licensed Blood Establishments

Table 10

DONOR SCREENING (DS) 2,052

# Reports

% of Total (DS)

Incorrect ID used during deferral search

1,283

62.5%

Donor not previously deferred

1,221

59.5%

Donor previously deferred due to history

42

2.0%

Donor previously deferred due to testing

20

1.0%

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

375

18.3%

Travel to malaria endemic area/history of malaria

215

10.5%

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

64

3.1%

Received medication or antibiotics

17

0.8%

Donor record incomplete or incorrect

333

16.2%

Donor history questions

281

13.7%

Incorrect gender specific question asked

174

8.5%

Donor identification

29

1.4%

Donor signature missing

7

0.3%

Donor did not meet acceptance criteria

35

1.7%

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

18

0.9%

Temperature unacceptable or not documented

7

0.3%

Deferral screening not done or incorrectly performed

25

1.2%

Donor previously deferred due to history

18

0.9%

Donor previously deferred due to testing

7

0.3%

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

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

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

Table 11

QC & DISTRIBUTION (QC) 1,421

# Reports

% of Total (QC)

Distribution of product that did not meet specifications

1,013

71.3%

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

609

42.9%

Bacterial detection testing

319

22.4%

Platelet count

131

9.2%

White Blood Cell count

59

4.2%

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

94

6.6%

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

81

5.7%

Other - Product distributed prior to required record review

78

5.5%

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

31

2.2%

Shipping and storage

212

14.9%

No documentation that product was shipped or stored at appropriate temperature

57

4.0%

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

52

3.7%

Product arrived at consignee at unacceptable temperature

31

2.2%

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

91

6.4%

Product not documented or incorrectly documented as issued in the computer

19

1.3%

Product not irradiated as required

14

1.0%

Product not leukoreduced as required

13

0.9%

Testing not performed, incompletely performed, or not documented

56

3.9%

Antigen screen

10

0.7%

Antibody screen or identification

9

0.6%

Failure to quarantine unit due to medical history:

28

2.0%

Post donation illness

17

1.2%

Positive testing

21

1.0%

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

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

Most Frequent BPD Reports – Blood Collection From Licensed Blood Establishments

Table 12

BLOOD COLLECTION (BC) 971

#Reports

% of Total (BC)

Collection process

888

91.5%

Product contained clots, not discovered prior to distribution

741

76.3%

Apheresis collection process

52

5.4%

Product hemolyzed, not discovered prior to distribution

43

4.4%

Sterility compromised

62

6.4%

Arm prep not performed or performed inappropriately

23

2.4%

Air contamination

22

2.3%

Bacterial contamination

17

1.8%

Collection bag

18

1.9%

Potential collection set defect

15

1.5%

Blood drawn into outdated bag

3

0.3%

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

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

Most Frequent BPD Reports - Miscellaneous From Licensed Blood Establishments

Table 13

MISCELLANEOUS (MI) 691

# Reports

% of Total (MI)

Lookback; subsequent unit tested confirmed positive for:

666

96.4%

HCV

369

53.4%

HIV

163

23.6%

HBV

68

9.8%

2x Anti-HBc positive

20

2.9%

Chagas

23

3.3%

HTLV

13

1.9%

West Nile Virus

5

0.7%

Donor implicated in transfusion associated disease

25

3.6%

Babesia

14

2.0%


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

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

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

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

Table 14

QC & DISTRIBUTION (QC) 1,764

# Reports

% of Total (QC)

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

1,349

76.5%

Product not documented or incorrectly documented as issued in the computer

613

34.8%

Product not irradiated as required

190

10.8%

Improper product selected for patient

124

7.0%

Procedure for issuing not performed or documented in accordance with specifications

78

4.4%

Product issued to wrong patient

68

3.9%

Improper ABO or Rh type selected for patient

66

3.7%

Testing not performed, incompletely performed, or not documented

246

13.9%

Antibody screen or identification

66

3.7%

ABO and/or Rh

53

3.0%

Compatibility

53

3.0%

Antigen screen

53

3.0%

Distribution of product that did not meet specifications::

135

7.7%

Product QC unacceptable, not performed, not documented or incomplete

62

3.5%

Bacterial detection testing

37

2.1%

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

38

2.2%

Outdated product

16

0.9%

Shipping and storage

28

1.6%

Stored at incorrect temperature

7

0.4%

No documentation that product was shipped or stored at appropriate temperature

7

0.4%

Temperature not recorded or unacceptable upon return, unit redistributed

7

0.4%

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

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

Most Frequent BPD Reports - Labeling From Unlicensed Registered Blood Establishments

Table 15

LABELING (LA) 1,022

#Reports

% of Total (LA)

Crossmatch tag or tie tag labels incorrect or missing information

547

53.5%

Crossmatch tag switched, both units intended for the same patient

148

14.5%

Recipient identification incorrect or missing

136

13.3%

Unit, lot, or pool number incorrect or missing

92

9.0%

Labels applied to blood unit or product incorrect or missing information

282

27.6%

Extended expiration date or time

129

12.6%

Product type or code incorrect or missing

33

3.2%

ABO and/or Rh incorrect or missing

31

3.0%

Donor/unit number or lot number incorrect or missing

23

2.3%

Transfusion record (crossmatch slip) incorrect or missing information

193

18.9%

Transfusion record switched, both units intended for the same patient

60

5.9%

Unit, lot, or pool number incorrect or missing

37

3.6%

Recipient identification incorrect or missing

29

2.8%

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

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

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

Table 16

POST DONATION INFORMATION (PD) 422

# Reports

% of Total (PD)

Behavior/History

389

92.2%

Travel to malaria endemic area/history of malaria

164

38.9%

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

88

20.9%

Donor received tattoo and/or piercing

30

7.1%

Illness

22

5.2%

Testing*

10

2.4%

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

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

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

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

Table 17

ROUTINE TESTING (RT) 410

# Reports

% of Total (RT)

Testing performed, interpreted, or documented incorrectly

237

57.8%

Compatibility

79

19.7%

Antibody screening or identification

69

16.8%

Antigen typing

39

9.5%

ABO and/or Rh

33

8.0%

Sample (used for testing) identification

109

26.6%

Sample used for testing was incorrectly or incompletely labeled

85

20.7%

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

16

3.9%

Incorrect sample tested

8

2.0%

Reagent QC unacceptable or expired reagents used

64

15.6%

Antigen typing

19

4.6%

Antibody screening or identification

15

3.7%

Multiple testing

7

1.7%

C. Most Frequent BPD Reports Submitted by Transfusion Services

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

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

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

Table 18

QC & DISTRIBUTION (QC) 986

# Reports

% of Total (QC)

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

701

71.1%

Product not documented or incorrectly documented as issued in the computer

336

34.1%

Product not irradiated as required

65

6.6%

Improper ABO or Rh type selected for patient

51

5.2%

Procedure for issuing not performed or documented in accordance with specifications

45

4.6%

Improper product selected for patient

43

4.4%

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

41

4.2%

Product issued to the wrong patient

29

2.9%

Product not leukoreduced as required

16

1.6%

Testing not performed, incompletely performed, or not documented

224

22.7%

Antibody screen or identification

71

7.2%

Antigen screen

59

6.0%

ABO and/or Rh

49

5.0%

Distribution of product that did not meet specifications:

36

3.7%

Outdated product

23

2.3%

Product QC unacceptable, not performed, not documented or incomplete

7

0.7%

Shipping and storage

25

2.5%

Stored at incorrect temperature

10

1.0%

No documentation that product was shipped or stored at appropriate temperature

5

0.5%

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

4

0.4%

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

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

 Most Frequent BPD Reports - Labeling From Transfusion Services

Table 19

LABELING (LA) 466

# Reports

% of Total (LA)

Crossmatch tag or tie tag labels incorrect or missing information

269

57.7%

Recipient identification incorrect or missing

73

15.7%

Crossmatch tag switched, both units intended for the same patient

57

12.2%

Unit, lot, or pool number incorrect or missing

45

9.7%

Crossmatch tag or tie tag missing or attached to incorrect unit

26

5.6%

Expiration date or time extended or missing

17

3.6%

Transfusion record (crossmatch slip) incorrect or missing information

150

32.2%

Recipient identification incorrect or missing

44

9.4%

Transfusion records switched, both units intended for the same patient

25

5.4%

Unit, lot, or pool number incorrect or missing

25

5.4%

Expiration date or time extended or missing

9

1.9%

Labels applied to blood unit or product incorrect or missing information

47

10.1%

Extended expiration date or time

25

5.4%

Donor number or lot number incorrect or missing

7

1.5%

Product type/code and expiration date incorrect or missing

4

0.9%

ABO and/or Rh incorrect or missing

4

0.9%

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

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

Most Frequent BPD Reports - Routine Testing From Transfusion Services

Table 20

ROUTINE TESTING (RT) 304

# Reports

% of Total (RT)

Testing performed, interpreted, or documented incorrectly

181

59.5%

Compatibility

58

19.1%

Antibody screening or identification

57

18.8%

Antigen typing

30

9.9%

ABO and/or Rh typing

26

8.6%

Sample (used for testing) identification

70

23.0%

Sample used for testing was incorrectly or incompletely labeled

54

17.8%

Unsuitable sample used for testing

9

3.0%

Incorrect sample tested

7

2.3%

Reagent QC unacceptable or expired reagents used

53

17.4%

Antibody screening or identification

18

5.9%

Multiple testing

14

4.6%

Antigen typing

10

3.3%

D. Most Frequent BPD Reports Submitted by Licensed Plasma Centers

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

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

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

Table 21

POST DONATION INFORMATION (PD) 18,038

# Reports

% of Total (PD)

Behavior/History

17,653

97.9%

Donor received tattoo and/or piercing

13,155

72.9%

Incarcerated

1,126

6.2%

Other; unacceptable address, donor unreliable

395

2.2%

Non-sexual exposure to Hepatitis C

332

1.8%

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

332

1.8%

IV drug use

318

1.8%

Testing *

372

2.1%

Tested reactive at another center, specific testing unknown

264

1.5%

Tested reactive for HCV post donation

40

0.2%

Tested reactive for HIV post donation

31

0.2%

Tested reactive for HBV post donation

20

0.1%

Illness

12

0.1%

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

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

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

Most Frequent BPD Reports - Miscellaneous From Licensed Plasma Centers

Table 22

MISCELLANEOUS (MI) 1,362

# Reports

% of Total (MI)

Lookback; subsequent unit tested confirmed positive for:

1,362

100.0%

HCV

725

53.2%

HBV

461

33.8%

HIV

172

12.6%

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

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

Most Frequent BPD Reports - Donor Screening From Licensed Plasma Centers

Table 23

DONOR SCREENING (DS) 622

# Reports

% of Total (DS)

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

192

30.9%

Donor received tattoo and/or piercing

135

21.7%

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

11

1.8%

Donor had history of surgery

8

1.3%

Donor record incomplete or incorrect

191

30.7%

Donor history questions

82

13.2%

Donor identification

50

8.0%

Donor signature missing

38

6.1%

Donor did not meet acceptance criteria

169

27.2%

Medical review or physical not performed or inadequate

128

20.6%

Unacceptable address or no proof of address

30

4.8%

Temperature unacceptable or not documented

10

1.6%

Deferral screening not done or incorrectly performed

66

10.6%

Donor previously deferred due to history

61

9.8%

Reason for deferral unknown

44

7.1%

Donor previously deferred due to testing

5

0.8%

Incorrect ID used during deferral search

4

0.6%

Donor not previously deferred

3

0.5%

Donor previously deferred due to history

1

0.2%

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

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

Table 24

Manufacturing System

Allergenic

Blood Derivative

In Vitro Diagnostic

Vaccine

351 HCT/P

TOTAL

Product Specifications

179

25

52

91

2

349

52.8%

Quality Control & Distribution

2

9

31

93

1

136

20.6%

Process Controls

9

35

6

13

0

63

9.5%

Labeling

7

4

14

16

1

42

6.4%

Testing

0

9

9

14

0

32

4.8%

Incoming Material

0

15

4

11

2

32

4.8%

Miscellaneous

0

2

1

4

0

7

1.1%

Total

197

99

117

242

6

661

100 %

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

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

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

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

Total Reports By Manufacturing System 361 HCT/P Establishments

Table 25

HCT/P Deviation Code

Cellular HCT/P

Non-Cellular HCT/P

Total

Donor Testing

27

56

83

29.0%

Processing and Processing Controls

64

17

81

28.3%

Receipt, Pre-Distribution, Shipment & Distribution

53

4

57

19.9%

Donor Eligibility

3

23

26

9.1%

Donor Screening

1

20

21

7.3%

Recovery

9

0

9

3.1%

Supplies and Reagents

0

4

4

1.4%

Labeling Controls

1

1

2

0.7%

Environmental Control

1

1

2

0.7%

Storage

1

0

1

0.3%

Total

160

126

286

100%

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V. Attachments

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

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

Back to the Biological Product Deviation Reports Annual Summaries

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