• 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

• 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

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• 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

• 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)

• 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)

• 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

• 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

• 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

• 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)

• 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)

• 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)

• 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

• 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)

• 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)

• 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)

• 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

• 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)

• 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)

• 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

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• 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

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• 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).

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