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THE EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINES & HEALTHCARE (EDQM)  2023 SARE Exercise (2022 data) SARE Reporting for Blood and Blood Components SoHO Standard Section, Department of Biological Standardization, OMCL Network & HealthCare (DBO) EDQM, Council of Europe 2 ©2023 EDQM, Council of Europe. All rights reserved.  2023 SARE Exercise (2022 data) SARE Summary Annual Report 3 ©2023 EDQM, Council of Europe. All rights reserved. Reporting Countries 2023 SARE Exercise (2022 data) DATA COLLECTED from 30 Countries: AT, BE, BG, CY, CZ, DE, DK, EE, EL, ES, FI, FR, HR, HU, IE, IS, IT, LI, LT, LU, LV, NL, NO, PL, PT, RO, SE, SI, SK, and UK (Northern Ireland) • 2021 SARE exercise: 30 reporting countries • 2022 SARE exercise: 30 reporting countries • 2023 SARE exercise: 30 reporting countries (same as in 2022 – MT + EL) *26 Member States + 4 Non-Member States 4 ©2023 EDQM, Council of Europe. All rights reserved. Summary 2023 SARE Exercise (2022 data) 2023 2018 2019 2020 2021 2022 (data 2022) (data 2017) (data 2018) (data 2019) (data 2020) (data 2021) Parameter Countries Countries Number Countries Number Countries Number Countries Number Countries Number reporting Number reporting reporting reporting reporting reporting Number of establishments 4028 3834 4009 3617 3307 3387 Units issued 29 25 093 906 28 22 922 191 27 22 863 118 30 22 104 136 30 20 633 199 30 21 382 065 Units transfused 24 20 674 603 23 19 310 224 22 19 334 629 24 18 881 223 26 17 808 869 24 16 957 730 Recipients transfused 19 3 522 623 19 3 262 767 17 3 228 635 19 3 167 732 20 2 912 307 22 3 029 184 SAR (1-3) 28 3 114 27 2 538 27 2 625 28 2 967 27 2 814 28 3 216 SAR (2-3) 26 1 871 24 1 687 26 1 674 26 1 756 24 1 379 27 1 516 SAR death (2-3) 8 28 7 20 10 26 9 24 11 25 9 27 # Units Processed 28 27,244,855 24 19,978,403 25 22,525,782 28 24,129,477 28 22,961,648 26 22,803,696 SAE 20 2 920 23 2 770 22 2 604 24 3 018 24 2 734 25 2 235 SAR in donors 23 4 635 23 6 239 24 3 821 28 4 025 23 2 946 22 2 935 5 ©2023 EDQM, Council of Europe. All rights reserved. Units Issued and Transfused (2021 - 2022) 2023 SARE Exercise (2022 data) Country Number of units Number of units Number of Units Number of Units D issued D transfused issued 2022 transfused 2022 Issued 2021 Transfused 2021 Austria (AT) 365,472 354,954 323,548 313,628 41,924 41,326 Belgium (BE) 498,757 501,521 518,514 512,521 -19,757 -11,000 Bulgaria (BG) 291,405 216,142 238,582 197,206 52,823 18,936 Croatia (HR) 252,538 242,853 256,870 245,223 -4,332 -2,370 Cyprus (CY) 90,013 87,004 87,467 84,050 2,546 2,954 Czechia (CZ) 560,162 556,974 569,628 567,467 -9,466 -10,493 Denmark (DK) 256,184 256,184 254,611 255,219 1,573 965 Estonia (EE) 59,952 59,584 63,869 62,349 -3,917 -2,765 Finland (FI) 202,696 211,621 -8,925 0 Fewer BE comparing to 2021: France (FR) 2,910,091 2,750,879 3,005,234 2,817,261 -95,143 -66,382 - 14 Germany (DE) 4,907,144 4,303,781 4,983,716 4,983,716 -76,572 -679,935 - 37 Greece (EL) 586,526 435,236 586,526 435,236 Hungary (HU) 541,383 535,512 214,322 5,871 -214,322 - 35 Iceland (IS) 16,025 14,330 14,552 13,389 1,473 941 Ireland (IE) 145,822 144,254 145,501 144,185 321 69 Italy (IT) 3,104,855 2,840,572 2,964,204 2,885,769 140,651 -45,197 Latvia (LV) 86,423 92,038 91,115 -5,615 -91,115 -4 Liechtenstein (LI) 205 205 221 221 -16 -16 Lithuania (LT) 142,159 127,126 15,033 0 Luxembourg (LU) 23,220 21,133 24,237 23,785 -1,017 -2,652 Malta (MT) 23,059 17,892 -23,059 -17,892 Netherlands (NL) 447,188 431,839 457,317 440,791 -10,129 -8,952 Norway (NO) 212,387 212,385 212,938 212,938 -551 -553 Poland (PL) 1,635,545 1,615,651 19,894 0 Portugal (PT) 372,793 350,455 372,143 352,078 650 -1,623 Romania (RO) 752,337 713,029 674,654 655,704 77,683 57,325 Slovakia (SK) 372,271 132,939 341,234 341,234 31,037 -208,295 Slovenia (SI) 102,686 101,897 789 0 Spain (ES) 1,849,153 1,849,153 1,883,734 1,883,734 -34,581 -34,581 Sweden (SE) 548,144 438,169 543,175 447,945 4,969 -9,776 UK (NI) 48,529 44,155 49,016 45,127 -487 -972 Total 21,382,065 16,957,730 20,691,869 17,808,869 690,196 -851,139 6 ©2023 EDQM, Council of Europe. All rights reserved. Data Completeness 2023 SARE Exercise (2022 data) Number of 3387 (3307 in 2021, 3617 in 2020, 261 BE withdrawn from the exercise due to establishments UK's withdrawal from the EU) No information on Data completeness 100%: 20 98 – 99%: 4 91%: 1 65 – 85%: 3 completeness: 2 No information on Number of units issued 100%: 21 95 – 98%: 2 84%: 1 0%: 1 completeness: 5 No information on Number of recipients 100%: 14 90 – 95%: 2 70 - 83%: 3 40 - 65%: 2 completeness: 9 Number of units No information on 100%: 17 90 – 94%: 3 90%: 1 71%: 1 transfused completeness: 8 7 ©2023 EDQM, Council of Europe. All rights reserved. Denominators 2023 SARE Exercise (2022 data) Number of Units Issued by Blood Component* Number of Units Transfused by Blood Component RBC, 15,906,955 RBC, 13,159,426 RBC, 13,375,434 RBC, 15,608,682 Plasma, 1,818,743 Platelets, 2,544,166 Plasma, 2,272,341 Platelets, 2,422,663 Platelets, 1,976,276 Plasma, 2,927,218 Platelets, 2,158,095 Plasma, 2,598,589 Whole blood, 3,285 Whole blood, 3,726 Whole blood, 2,999 Whole blood, 3,265 2,022 2,021 2,022 2,021 Countries Countries Total (x106 units) Total (x106 units) reporting reporting 2022 21.4 30 2022 16.9 24 2021 20.6 30 2021 17.8 26 The lower number of units transfused in 2022 is due to lower * Including data on transfused units from ES, LI and NO volume reported (DE, SK, FR) or no longer reporting (HU, LV). 8 ©2023 EDQM, Council of Europe. All rights reserved. Incidence 2023 SARE Exercise (2022 data) Number of units issued per 1000 population* Austria (AT) 41 Belgium (BE) 43 Bulgaria (BG) 43 Croatia (HR) 65 Cyprus (CY) 99 Czechia (CZ) 53 Denmark (DK) 44 Estonia (EE) 45 Finland (FI) 37 France (FR) 43 Germany (DE) 59 Greece (EL) 56 Hungary (HU) 56 Iceland (IS) 43 Ireland (IE) 29 Italy (IT) 53 Latvia (LV) 46 Liechtenstein (LI) 5 Lithuania (LT) 51 Luxembourg (LU) 36 Netherlands (NL) 25 Norway (NO) 39 Poland (PL) 43 Portugal (PT) 36 Romania (RO) 40 Slovakia (SK) 68 Slovenia (SI) 49 Spain (ES) 39 Sweden (SE) 52 UK (NI) 25 0 20 40 60 80 100 *population as of January 1st 2022, https://ec.europa.eu/eurostat/web/population-demography/demography-population-stock-balance/database 9 ©2023 EDQM, Council of Europe. All rights reserved. Incidence 2023 SARE Exercise (2022 data) Number of units transfused per 1000 population* Austria (AT) 40 Belgium (BE) 43 Bulgaria (BG) 32 Croatia (HR) 63 Cyprus (CY) 96 Czechia (CZ) 53 Denmark (DK) 44 Estonia (EE) 45 France (FR) 41 Germany (DE) 52 Greece (EL) 42 Iceland (IS) 38 Ireland (IE) 29 Italy (IT) 48 Liechtenstein (LI) 5 Luxembourg (LU) 33 Netherlands (NL) 25 Norway (NO) 39 Portugal (PT) 34 Romania (RO) 37 Slovakia (SK) 24 Spain (ES) 39 Sweden (SE) 42 UK (NI) 23 0 10 20 30 40 50 60 70 80 90 100 *population as of January 1st 2022, https://ec.europa.eu/eurostat/web/population-demography/demography-population-stock-balance/database 10 ©2023 EDQM, Council of Europe. All rights reserved. Incidence 2023 SARE Exercise (2022 data) Number of units transfused pmp by country and blood component RBC Platelets Plasma WB Country 2022 2021 2022 2021 2022 2021 2022 2021 Austria (AT) 34,933 30,923 4,383 3,841 216 346 Belgium (BE) 33,517 34,949 5,389 5,668 4,263 3,739 Bulgaria (BG) 16,718 14,886 3,976 3,576 10,910 10,047 1.0 2.9 Croatia (HR) 45,207 43,451 7,405 7,020 10,266 10,283 Cyprus (CY) 74,556 72,168 6,866 6,615 14,745 15,022 1.1 Czechia (CZ) 40,210 40,109 4,229 4,474 8,351 9,355 170.7 133 Denmark (DK) 31,395 31,226 5,781 6,067 6,442 6,409 Estonia (EE) 33,285 33,495 5,116 5,282 6,337 8,094 1.5 4.5 France (FR) 32,341 33,422 4,985 4,945 3,202 3,272 3.2 2 Germany (DE) 38,521 42,279 5,811 7,165 7,374 10,489 Greece (EL) 32,078 27,091 9,532 5,564 3,650 Iceland (IS) 27,729 24,328 7,375 4,472 2,982 Ireland (IE) 24,060 40,747 4,445 3,999 3,970 3.2 0.2 Italy (IT) 40,552 28,310 4,087 4,500 3,481 15,317 0.1 0.3 Liechtenstein (LI) 5,037 5,505 178 77 77 Luxembourg (LU) 26,993 28,789 1,407 4,881 4,345 3,803 Malta (MT) - 26,985 - 3,893 - 3,790 Netherlands (NL) 21,650 22,225 2,848 2,957 51 42 Norway (NO) 27,278 27,450 4,378 4,406 7,491 7,538 102.6 Portugal (PT) 27,627 28,139 5,091 4,939 1,135 1,109 1.4 1 Romania (RO) 20,252 18,258 6,437 5,579 10,693 10,270 62.8 41.4 Slovakia (SK) 15,437 37,606 1,603 4,425 7,420 20,469 Spain (ES) 31,484 31,962 4,774 4,853 2,727 2,927 0.2 0.2 Sweden (SE) 33,999 35,013 4,503 4,509 3,417 3,631 2.4 4.3 UK (NI) 18,196 18,747 3,443 3,197 1,473 1,767 11 ©2023 EDQM, Council of Europe. All rights reserved. Incidence 2023 SARE Exercise (2022 data) Number of units transfused pmp by country and blood component 0 10,000 20,000 30,000 40,000 50,000 60,000 70,000 80,000 90,000 Austria (AT) 34,933 4,383 216 Belgium (BE) 33,517 5,389 4,263 Bulgaria (BG) 16,718 3,976 10,910 1.0 Croatia (HR) 45,207 7,405 10,266 Cyprus (CY) 74,556 6,866 14,745 Czechia (CZ) 40,210 4,229 8,351 170.7 Denmark (DK) 31,395 5,781 6,442 Estonia (EE) 33,285 5,116 6,337 1.5 France (FR) 32,341 4,985 3,202 3.2 Germany (DE) 38,521 5,811 7,374 Greece (EL) 32,078 9,532 Iceland (IS) 27,729 7,375 2,982 Ireland (IE) 24,060 4,445 3.2 Italy (IT) 40,552 4,087 3,481 0.1 Liechtenstein (LI) 5,037 178 Luxembourg (LU) 26,993 1,407 4,345 Malta (MT) Netherlands (NL) 21,650 2,848 51 Norway (NO) 27,278 4,378 7,491 Portugal (PT) 27,627 5,091 1,135 1.4 Romania (RO) 20,252 6,437 10,693 62.8 Slovakia (SK) 15,437 1,603 7,420 Spain (ES) 31,484 4,774 2,727 0.2 Sweden (SE) 33,999 4,503 3,417 2.4 UK (NI) 18,196 3,443 1,473 RBC 2022 Platelets 2022 Plasma 2022 WB 2022 12 ©2023 EDQM, Council of Europe. All rights reserved. Units Issued and Transfused 2023 SARE Exercise (2022 data) Number of units Number of units Total number = total of RBC, platelets, plasma and whole blood (reported separately) Country issued* transfused Austria (AT) 365,472 354,954 Belgium (BE) 498,757 501,521 5.00 Bulgaria (BG) 291,405 216,142 4.50 Croatia (HR) 252,538 242,853 Cyprus (CY) 90,013 87,004 4.00 Czechia (CZ) 560,162 556,974 Denmark (DK) 256,184 256,184 3.50 Estonia (EE) 59,952 59,584 Finland (FI) 202,696 3.00 France (FR) 2,910,091 2,750,879 2.50 Germany (DE) 4,907,144 4,303,781 Greece (EL) 586,526 435,236 2.00 Hungary (HU) 541,383 Iceland (IS) 16,025 14,330 1.50 Ireland (IE) 145,822 144,254 Italy (IT) 3,104,855 2,840,572 1.00 Latvia (LV) 86,423 Liechtenstein (LI) 205 205 0.50 Lithuania (LT) 142,159 0.00 Luxembourg (LU) 23,220 21,133 Netherlands (NL) 447,188 431,839 Norway (NO) 212,387 212,385 Poland (PL) 1,635,545 Portugal (PT) 372,793 350,455 Romania (RO) 752,337 713,029 Number of units issued (mil.) Number of units transfused (mil.) Slovakia (SK) 372,271 132,939 Slovenia (SI) 102,686 Spain (ES) 1,849,153 1,849,153 Sweden (SE) 548,144 438,169 UK (NI) 48,529 44,155 * Including data on transfused units from ES, LI and NO Total 21,382,065 16,957,730 13 ©2023 EDQM, Council of Europe. All rights reserved. Reporting COVID Convalescent Plasma 2023 SARE Exercise (2022 data) • Approach varies among countries • The inclusion of CCP in the analysis has negligible impact due to the limited number of CCP units (5906 units issued, 4909 units transfused, and 1551 recipients reported in 2021) FI: 264 plasma units are COVID-19 convalescent plasma units and were issued to a clinical study. FR: The CCP denominators and SARs related to CCP were included in regular plasma figures as data was not available at the time of reporting for SARE HR: In denominators for plasma, numbers for CCP were excluded (2179 units of CCP issued and 541 recipients transfused with 1985 units of CCP). NL: 445 units distributed (issued), 202 recipients, and 376 units transfused. These distributed and transfused CCP units are not included in the regular plasma figures. 2 SARs were reported after transfusion of anti-COVID-19-plasma: 1 classified as Other transfusion reaction, non-fatal, IL2 (probable), 1 classified as Other transfusion reaction, fatal, IL1 (possible) PL: 590 units were issued for clinical use. No SAR following CCP transfusion were reported. 14 ©2023 EDQM, Council of Europe. All rights reserved. Units Transfused and Recipients 2023 SARE Exercise (2022 data) Number of units Recipients transfused Reporting Countries transfused Recipients transfused AT, BE, BG, HR, CY, CZ, Blood (million units) By type of blood 2,774 mil. 19 DK, ES, FR, IS, IE, IT, LI, component 2022 2021 component LU, NL, PT, SK, SE and NI Red blood cells 2,281 2,226 Regardless of Platelets 0,270 0,278 component type 0,320 mil. 3 EE, EL and RO Plasma 0,222 0,247 Whole Blood 0,001 0,001 Total 2,774* 2,752* Total 3,094 mil. 22 16,957 mil. Recipients transfused 2022: 3,094 mil. recipients of 16,957 mil. units 2021: 2,912 mil. recipients of 17,809 mil units Platelets 269,975 10% RBC 2,281,248 82% Plasma 221,567 8% *Data does not reflect the number and type of units transfused per patient; WB 1,583 a patient who received more than one blood component is counted multiple 0% times 15 ©2023 EDQM, Council of Europe. All rights reserved. SAR/Es Reported 2023 SARE Exercise (2022 data) Serious Adverse Reactions (recipient) 3 216 2 814 in 2021 2 967 in 2020 - imputability level 1-3 3 216 SAR - imputability level 2-3 1 516 SAR (1 379 in 2021, 1 756 in 2020) 27 fatalities (25 in 2021, 24 in 2020) NOTE: The actual number of SAR IL1 is higher as some countries do not report them. For instance, ES and SE report SAR 2 and 3 only. Serious Adverse Events 2 235 2 734 in 2021 3 018 in 2020 Serious Adverse Reactions (donor) 2 935 2 946 in 2021 4 025 in 2020 16 ©2023 EDQM, Council of Europe. All rights reserved.  2023 SARE Exercise (2022 data) Serious Adverse Reactions (in recipients) 28 Countries: AT, BE, BG, HR, CY, CZ, DK, EE, FI, FR, DE, HU, IE, IT, LV, LI, LT, LU, NL, NO, PL, PT, RO, SK, SI, ES, SE and UK(NI) 17 ©2023 EDQM, Council of Europe. All rights reserved. SAR by Type of Blood Component 2023 SARE Exercise (2022 data) Total = 16,957,730 Total = 1,516 Total = 27 Total = 3,170 Total = 3,216 3,285 100% 45 91 97 1,818,743 4 282 284 90% 176 1,976,276 2 80% 694 698 389 4 70% 60% 50% 40% 13,159,426 30% 17 2,103 2,137 906 20% 10% 0% Units transfused Total SAR Death No Death Total SAR 2022 (level 2+3) (level 2+3) (level 2+3) (level 1-3) 2022 2022 2022 2022 Total SAR Death No Death Total SAR Units transfused 2022 (level 2+3) (level 2+3) (level 2+3) (level 1-3) 2022 2022 2022 2022 More than one blood 45 4 91 97 component transfused Whole blood 3,285 Plasma 1,818,743 176 2 282 284 Platelets 1,976,276 389 4 694 698 Red blood cells 13,159,426 906 17 2,103 2,137 18 ©2023 EDQM, Council of Europe. All rights reserved. SAR by Type of Blood Component 2023 SARE Exercise (2022 data) (2021 - 2022) 3,285 2,999 100% 45 45 91 43 97 78 1,818,743 2 2,158,095 4 282 284 238 90% 176 149 149 1,976,276 2,272,341 2 4 80% 694 698 571 389 4 70% 356 352 60% 50% 40% 13,375,434 13,159,426 17 17 2,103 2,137 1,600 30% 906 697 680 20% 10% 0% Units Units Total SAR Total SAR Death Death No Death No Death Total SAR Total SAR transfused transfused (level 2+3) (level 2+3) (level 2+3) (level 2+3) (level 2+3) (level 2+3) (level 1-3) (level 1-3) 2022 2021 2022 2021 2022 2021 2022 2021 2022 2021 Red blood cells Platelets Plasma Whole blood More than one blood… 19 ©2023 EDQM, Council of Europe. All rights reserved. Incidence of SAR and Fatalities 2023 SARE Exercise (2022 data) by Type of Blood Component Fatalities Fatalities Fatalities Fatalities (%) incidence (per incidence (per SAR (2+3) SAR (2+3) (%) among among SAR 2- 100 000 units 100 000 units Total SAR incidence incidence SAR 2-3 3 transfused) transfused) (per 100 000 (per 100 000 Total units units Component Units (IL 1-3) SAR (IL transfused) transfused) Fatalities (IL 2022 2021 2022 2021 type transfused 2-3) 2022 2021 2-3) Red blood cells 13,159,426 2,137 906 6,9 5,4 17 1,9% 2,6% 0.13 0,14 Platelets 1,976,276 698 389 19,7 17,3 4 1,0% 1,1% 0.20 0,18 Plasma 1,818,743 284 176 9,7 7,2 2 1,1% 0% 0.11 0 Whole blood 3,285 66,7 More than one blood component transfused 97 45 4 8,9% 4,6% NA Total 16,957,730 3,216 1,516 8,9 7,3 27 1,8% 1,7% 0.16 0,13 20 ©2023 EDQM, Council of Europe. All rights reserved. SAR (IL 2-3) Incidence 2023 SARE Exercise (2022 data) per 100 000 Units Transfused Country SAR Incidence SAR Incidence per 100 000 per 100 000 units transfused units 2021 transfused 2022 Austria (AT) 6.8 Austria (AT) 22.0 6.8 Belgium (BE) 12.2 Belgium (BE) 2.5 12.2 Bulgaria (BG) 0.5 Bulgaria (BG) 0.5 0.5 Croatia (HR) 2.9 Croatia (HR) 5.3 2.9 Cyprus (CY) 1.1 Cyprus (CY) 1.1 Czechia (CZ) 3.4 Czechia (CZ) 2.6 3.4 Denmark (DK) 4.3 Denmark (DK) 2.4 4.3 Estonia (EE) 8.4 Estonia (EE) 12.8 8.4 France (FR) 2.9 France (FR) 2.5 2.9 Germany (DE) 5.5 Germany (DE) 3.6 5.5 Greece (EL) 12.9 Greece (EL) 12.9 Iceland (IS) 0.0 Hungary (HU) 7.5 Ireland (IE) 32.6 Iceland (IS) 0.0 Italy (IT) 22.7 Ireland (IE) 38.8 32.6 Liechtenstein (LI) 0.0 Italy (IT) 20.1 22.7 Luxembourg (LU) 0.0 Latvia (LV) 3.3 Netherlands (NL) 9.3 Liechtenstein 0.0 Norway (NO) 4.7 (LI) Portugal (PT) 2.3 Luxembourg 0.0 Romania (RO) 0.8 (LU) Slovakia (SK) 53.4 Netherlands (NL) 11.8 9.3 Spain (ES) 4.6 Norway (NO) 16.4 4.7 Sweden (SE) 3.2 Portugal (PT) 5.7 2.3 Romania (RO) 1.4 0.8 0.0 10.0 20.0 30.0 40.0 50.0 Slovakia (SK) 18.2 53.4 SAR Incidence per 100 000 units transfused Spain (ES) 3.8 4.6 Sweden (SE) 4.5 3.2 UK (NI) 13.3 15.9 21 ©2023 EDQM, Council of Europe. All rights reserved.  Distribution of SAR (IL 1-3) 2023 SARE Exercise (2022 data) by BC Type (3216) Red Blood Cells Platelets Plasma More than one blood component transfused 100% 1 2 2 16 1 1 3 1 54 1 5 1 1 5 1 105 1 7 44 17 26 90% 1 2 1 3 9 5 4 3 17 14 15 1 12 5 37 2 4 80% 28 136 5 2 367 19 1 1 4 1 2 70% 1 22 2 13 5 2 2,137 60% 2,000 4 31 50% 1 1 50 1,500 40% 4 18 87 9 65 64 25 12 585 113 6 14 54 11 4 30% 11 824 46 10 52 6 1,000 12 1 706 20% 49 6 500 10% 276 97 0% 0 Red Blood Cells Platelets AT BE BG HR CY CZ DK EE ES FI FR DE EL HU IE IT LV LT LU NL NO PL PT RO SK SI SE UK(NI) Plasma No of ES: 215 106 29 7 6 185 5 28 488 1 765 67 109 130 65 276 52 3 5 83 19 23 270 376 44 3 25 9 More than one blood component transfused 22 ©2023 EDQM, Council of Europe. All rights reserved. Distribution of SAR (IL 2-3) 2023 SARE Exercise (2022 data) by BC Type (1516) 100% 1 10 1 1 1 3 4 1 1 21 1 8 73 10 1 90% 3 1 12 3 2 3 21 12 10 2 1 11 12 5 28 2 80% 3 8 1 1 20 1 1 2 202 7 70% 59 2 906 12 900 1 60% 800 4 19 700 50% 1 1 1 7 600 40% 20 4 11 6 44 5 35 29 53 5 500 12 7 54 33 4 389 30% 6 5 134 32 359 400 1 20% 33 6 300 176 200 10% 100 45 0% 0 Red Blood Cells Platelets Red Blood Cells Platelets Plasma More than one blood component transfused Plasma More than one blood component transfused 23 ©2023 EDQM, Council of Europe. All rights reserved. SAR (IL 2-3) by Type of Reaction 2023 SARE Exercise (2022 data) Other 410 412 Febrile non-haemolytic transfusion 349 334 Anaphylaxis/hypersensitivity 282 217 TACO 200 185 Immunological Haemolysis 136 116 IL 2022 2021 TRALI 55 IL2 1 212 1 121 38 39 IL3 304 258 TAD 41 Total 1 516 1 379 Hypotensive transfusion reaction 16 14 Transfusion-transmitted bacterial infection 12 11 Non-immunological Haemolysis 12 3 Transfusion-transmitted viral infection 2 4 Post-transfusion purpura 2 3 Transfusion-transmitted parasitical infection 1 Transfussion-transmitted prion infection 0 Transfusion-transmitted fungal infection 0 Transfusion associated graft versus host disease 0 1 0 50 100 150 200 250 300 350 400 450 2022 2021 24 ©2023 EDQM, Council of Europe. All rights reserved. SAR (IL 2-3) category “Other” 2023 SARE Exercise (2022 data) Allergic reaction 317 Other 48 Mild allergic reactions 9 Unclassified; pyrexia, tachycardia, chills rigors, headache 6 Delayed haemolytic transfusion reaction (DHTR) 5 Other complication 3 No information available 3 Respiratory disorders (other than TRALI) 3  410 SARs in recipients classified as “other” in 2022 ( 412 in 2021 Hypertension 3 and 487 in 2020) Unknown 2  accuracy of classification? Other transfusion reaction 2 Circulatory disorders (other than TACO) 2 Hyperhemolityc Syndrome 2 Vomiting, dypnea and fever due to Anti-Fya antibodies 1 Tachycardia 1 Unclassified (urticaria, rash, itch, lip and facial swelling) 1 Immunological haemolysis due to autoantibodies 1 Hypotension 1 0 50 100 150 200 250 300 25 ©2023 EDQM, Council of Europe. All rights reserved. SAR (IL 2-3) by BC Type 2023 SARE Exercise (2022 data) More than one Red blood cells Platelets Plasma blood component Whole Blood SAR Type (IL 2-3) transfused All No Death Death No death Death No Death Death No Death Death No Death Death No Death Death Total Anaphylaxis/hypersensitivity 74 123 1 67 17 281 1 282 Immunological Haemolysis due to ABO incompability 115 8 4 6 1 125 9 134 Immunological Haemolysis due to other allo-antibody 2 2 2 Non-immunological Haemolysis 12 12 12 Post-transfusion purpura 1 1 2 2 Transfusion related acute lung injury (TRALI) 30 3 8 1 3 1 5 4 46 9 55 Transfusion-transmitted bacterial infection 4 2 4 2 8 4 12 Transfusion-transmitted parasitical infection 1 1 1 Transfusion-transmitted fungal infection Transfusion-transmitted viral infection 1 1 2 2 Transfusion associated Graft versus host disease TACO 174 4 8 10 4 196 4 200 Febrile non-haemolytic transfusion 272 69 5 3 349 349 TAD 29 7 3 39 39 Hypotensive transfusion reaction 10 5 1 16 16 Transfussion-transmitted prion infection Other 166 156 79 9 410 410 Total 889 17 385 4 174 2 41 4 0 0 1489 27 1516 26 ©2023 EDQM, Council of Europe. All rights reserved. Transfusion Transmitted Infections 2023 SARE Exercise (2022 data) TTY Total Fatalities RBC Patelets More than one Category infection component related No fatalities Fatalities No fatalities Fatalities No fatalities Fatalities SAR & IL & IL & IL & IL & IL & IL TTBI 26 4 13 2 9 2 - - (BE, DE, 9 IL1 IL2 5 IL1 1 IL2 IT, SE) 3 IL2 3 IL2 1 IL3 1 IL3 1 IL3 TTVI 3 - 1 HCV IL1 - - - 1 CMV IL2 - (EE, DE, 1 HBV IL2 IE) • HBV infection (IL2) Repeat donor tested indeterminate for NAT screening (HIV, HBV, HCV) and positive for HBc antibody. Lookback included all previous donations. All previous donations showed negative NAT screening, positive HBc antibody and positive HBs antibody (11,3 - 10,4 IU/L). As part of the review, two blood recipients were tested for HBV (HBV ag, HBe ab, HBc ab). One recipient (tested 19 months after potentially infectious transfusion) was positive for HBc ab (negative for HBs ag and HBe ab). Recipient had not been tested for HBV before blood transfusion so it cannot be ruled out, that recipient had HBV exposure before transfusion. EE • HCV infection, IL possible. The patient was transfused with RCC in the early1990s. The donation numbers provided to the BE were incomplete, thus preventing trace back. IE NO description/comments provided for 27 out of 29 transfusion transmitted infections. 27 ©2023 EDQM, Council of Europe. All rights reserved. Fatalities by Type of Reaction and IL 2023 SARE Exercise (2022 data) SAR IL 1 N= 19 SAR IL (2-3) N= 27 TACO 11 Transfusion related acute lung injury (TRALI) 9 Anaphylaxis/hypersensitivity 3 Immunological Haemolysis due to ABO 8 incompability Other 2* TACO 4 Immunological Haemolysis due to other allo- 1 Transfusion-transmitted bacterial infection 4 antibody Immunological Haemolysis due to other allo- Febrile non-haemolytic transfusion 1 1 antibody Non-immunological Haemolysis 1 Anaphylaxis/hypersensitivity 1 0 2 4 6 8 10 12 0 2 4 6 8 10 *UK(NI): 1 other - Uncommon complications of transfusion (SHOT category) DK: 1 other - Unknown 7 Countries: DE, FI, FR, DK, HU, NL, and UK 9 Countries: BE, ES, FI, FR, DE, EL, HU, NL, and UK 28 ©2023 EDQM, Council of Europe. All rights reserved. Fatalities by Type of Reaction and IL (2021 - 2022) 2023 SARE Exercise (2022 data) SAR IL 1 (2021 - 2022) SAR IL 2-3 (2021 - 2022) 25 TACO 30 Anaphylaxis/hypersensitivity TACO 20 25 4 Other Immunological Haemolysis due 12 8 to ABO incompability 20 Transfusion related acute 8 15 lung injury (TRALI) Immunological Haemolysis due to other allo-antibody 11 Immunological Haemolysis 15 due to ABO incompability 1 Transfusion related acute lung 8 10 TAD injury (TRALI) 3 10 9 Other 2 Immunological Haemolysis 3 3 5 2 due to other allo-antibody 2 5 Transfusion-transmitted Febrile non-haemolytic 3 2 bacterial infection 1 transfusion 4 1 1 2 1 1 Non-immunological Anaphylaxis/hypersensitivity 0 0 1 1 Haemolysis Fatalities 2021 Fatalities 2022 Fatalities 2021 Fatalities 2022 N= 23 N= 19 N= 25 N= 27 29 ©2023 EDQM, Council of Europe. All rights reserved. Fatalities in Recipients 2023 SARE Exercise (2022 data) Country & #SAR RBC Platelets Plasma MTOC Requirements for reporting fatalities in recipients as stated in the BE (1) 1 IL2 Common Approach not met: 7 IL1 DE (23) 2 IL2 2 IL2 1 IL3 1 IL1 • Requirements met (fully or partially) by 10 out of 46 (22%) 1 IL3 3 IL2 6 IL3 cases reported DK (1) 1 IL1 EL (1) 1 IL3 • Requirements not met by 36 out of 46 (78%) fatality cases ES (1) 1 IL2 (NO information provided apart from BC transfused and IL). 2 IL1 FI (5) 1 IL2 1 IL2 1 IL3 Common Approach, edition 2023: “Concerning reports where an SAR is confirmed to be 1 IL1 fatal, any relevant information should be reported in the comments box, such as: FR (4) 3 IL3 (1) a brief description of patient details (if possible: gender, age, initial illness, clinical 1 IL1 HU (2) 1 IL2 indications for transfusion etc.), 4 IL1 (2) a brief description of the occurrences that led to the fatality, NL (6) 1 IL2 (3) a list of transfused units of blood/blood components; for each unit, any relevant UK (2) 1 IL1 information regarding the preparation of the implicated component(s) (leucodepletion, 1 IL2 apheresis...), Total = 46 35 4 2 5 (4) the conclusions and follow-up actions (corrective and preventive), if appropriate.” 30 ©2023 EDQM, Council of Europe. All rights reserved. Fatalities in Recipients 2023 SARE Exercise (2022 data) RBC Case #1: 75-year-old female patient with a history of stented ischemic heart disease and hypertension, and essential thrombocythemia since 2003, probably progressing to myelofibrosis under treatment (JAKAVI and KARDEGIC). She was hospitalized in haematology for severe anaemia with significant clinical repercussions (exertional dyspnoea, and profound asthenia) and for diagnostic work-up of myelofibrosis. She was transfused with 3 red cells units (RC) for an anaemia at 67 g/L. The Hb control performed the next day finds 96 g/L. Medical decision to transfuse 2 others RC units: the 1st one was transfused at 1:05 p.m.; the constants between 2 p.m and 3 p.m were: T° 36.7°C, arterial pressure (AP) 135/79 mmHg, TT 72, SaO2 96%. The 2nd RC was transfused at 3:30 p.m., the constants between 4:00 p.m and 5:00 p.m were: T° 37.2, AP 157/90, TT 81, SaO2 95%. These constants between 5:00 p.m and 6:00 p.m show an AP of 156/92. The nurse notes the hypertension at the end of the transfusion of the 2nd RC unit, and informs the physician, and continues the monitoring of the patient. The patient feels well and asymptomatic, she has returned home at 6:00 p.m. During dinner, she presents with a feeling of malaise associated with dyspnoea; she goes to the bathroom with the help of her husband. He noticed that she was less and less reactive, called the emergency medical service (EMS) at 7:25 p.m.; the EMS arrived at 7:55 p.m.; the patient was in cardio-respiratory arrest. Cardiopulmonary resuscitation is started by the EMS at 8:05 p.m., the scope indicates asystole. Spontaneous circulatory activity resumes only after intubation and 4 mg of adrenaline. She was hospitalized again in intensive care at 9 p.m. Post-resuscitation electrocardiogram shows left bundle branch block. The X-ray of the 2 lungs was consistent with acute pulmonary oedema. The ETT found left ventricular dysfunction between 30 and 40%. The BNP level was at 115, Troponin = 3.203 (n = 0.000-0.016) and Hb 122 g/L at 10:50 p.m. Three hours after hospitalisation, the hemodynamic situation worsened, and death was recorded at 01:25 on 09/15. The investigation performed concluded that the occurrence of this death was definitely attributable to the transfusion (5 RC units transfused in 36 hours in an elderly patient with stented ischemic heart disease). FR Investigation conducted? Cause(s)? Actions? 31 ©2023 EDQM, Council of Europe. All rights reserved. Fatalities in Recipients cont. 2023 SARE Exercise (2022 data) RBC cont. Case #2: 69-year-old female patient with a history of hypertension, left carotid artery stent and obliterative arteritis of the lower limbs, admitted to the emergency department for management of poorly tolerated anemia (48 g/L) on significant melena. She was transfused with 4 RC units and 2 plasmas units between 10 p.m. and 5 a.m. Soon after the end of the last blood component transfused, clinical symptoms of acute pulmonary oedema were observed, complicated by cardio-respiratory arrest despite the treatment instituted (Lasix + Risordan) requiring intubation and a heart massage without success. The investigation carried out concluded that occurrence of this death was definitely attributable to the transfusion (4 RC and 2 plasmas units transfused in 6 hours and the 2 first RC were transfused each in 1 hour). FR Investigation conducted? Cause(s)? Actions? Case #3: 7-year-old female patient with a history of Crohn's disease, severe spastic paraparesis, valvular and ischemic heart disease, admitted to the emergency department for treatment of severe anaemia (Hb 22 g/L) in a context of deterioration of general condition. She weighs 40 kg. She was transfused with 4 RC units (immediate life-threatening emergency). The respective transfusion times: 2:20 p.m., 3:27 p.m., 4:50 p.m. and 6:53 p.m. Occurrence of TACO around 10p.m. requiring the establishment of a CPAP (continuous positive pressure in the airways) and the administration of diuretics. Around midnight, rapid neurological deterioration and the patient's death. No resuscitative measures according to advance directives. (IL3) FR Investigation conducted? Cause(s)? Actions? Case #4: 87-year-old female patient with a history of phlebitis and thrombophlebitis of the lower limbs, sleep apnea, chronic atrial fi brillation, arterial hypertension, chronic edema of the lower extremities, admitted to the emergency department for management of a left calf bleed under xarelto. She has a voluminous hematoma of the calf of 15X10 cm. It was decided to transfuse her with one RC unit for anemia at 70 g/L and one unit of plasma. The duration of the transfusion was around 2 hours. Symptoms of of acute pulmonary oedema onset 5 hours after the end of the transfusion. The patient was treated with a diuretic(Lasix) without significant improvement. Progressive deterioration of the respiratory state and death of the patient approximately 7 hours after the end of the transfusion. There was no autopsy. TACO was considered a possible cause of death. (IL1) FR 32 ©2023 EDQM, Council of Europe. All rights reserved. Fatalities in Recipients cont. 2023 SARE Exercise (2022 data) RBC Female (65 years old) received emergency RBC transfusion, 2 c-antigen positive units. Patient died 2 days later, probably because of her underlying condition (IL 1). FI Male (69 years old) was blood group antibody screening negative, received 17 crossmatched RBC units for his underlying condition. A week later antibody screening turned positive, patient developed a severe haemolysis and died despite of intensive care. It was later noticed that he had been found out to be anti-E positive in screening done 24 year earlier, but the old paper documentation had not been moved to hospital's electronic patient record system, so the information was missing from the patient’s records (IL3). FI Male (18 years old) was in open heart surgery, received several RBC products, developed massive pulmonary oedema and TRALI. Two of the RBC donors were found out to have patient-specific leucocyte antibodies that could have caused the TRALI, and both donors were later deferred permanently (IL2). FI Male (72 years old) was blood group antibody screening negative, received a small volume (25 ml) of crossmatched RBC unit for his underlying condition. Patient was later found to have weak anti-E antibodies, and the transfused unit was E positive. Patient died 17 days later, probably because of his underlying condition (IL1). FI 33 ©2023 EDQM, Council of Europe. All rights reserved. Fatalities in Recipients cont. 2023 SARE Exercise (2022 data) RBC Female (85 years old): RBC (A+) destined for X is administered to Y (O+). The administration of blood products is done with electronic control at the patient's bedside with software Nurseflow, however, the nurse has not followed the procedure: she has printed a new wristband (in Nurseflow you can only scan a wristband and no label) and checked at nursing station. Since the RBC and wristband belonged to patient X, Nurseflow gave the green light. She then went into the wrong room, failed to check again, and administered RBC to the wrong patient. Noticed after 100 ml had already been transfused. Patient did not need a transfusion, was administered incorrectly. Patient has very strong signs of haemolysis, has developed lactic acidosis and was anuric. For this reason, dialysis was started 2 days after the incident. All parameters seemed to be gradually improving. Patient died 5 days later of bradycardia. (IL2) BE Cause(s)? Actions? Platelets Male (72 years old) admitted to hospital with septic shock and fever that had lasted several days, was found out to have Staphylococcus aureus, received 4 units of platelets, died less than a day later. (IL2) FI Investigation conducted? 34 ©2023 EDQM, Council of Europe. All rights reserved.  2023 SARE Exercise (2022 data) Serious Adverse Events 25 Countries: AT, BE, CY, CZ, DE, DK, EE, EL, ES, FI, FR, HR, IE, IS, IT, LV, NL, NO, PL, PT, RO, SE, SI, SK and UK(NI) (No SAE from BG, HU, LI, LT, and LU) 35 ©2023 EDQM, Council of Europe. All rights reserved. Incidence of SAE 2023 SARE Exercise (2022 data) per 100 000 Units Processed Country # Units SAE/100 000 SAE/100 000 units processed units processed Processed for SAEs 2022 2021 Austria (AT) 2 Austria (AT) 399,678 2 2.7 Belgium (BE) 109 Bulgaria (BG) 0 Belgium (BE) 616,377 109 100.8 Cyprus (CY) 62 Bulgaria (BG) 389,174 0 0.4 Czechia (CZ) 0 Croatia (HR) 189,458 1 2.1 Germany (DE) 3 Cyprus (CY) 67,942 62 1.5 Denmark (DK) 1 Czechia (CZ) 1,662,587 0 0.2 Estonia (EE) 60 Denmark (DK) 678,965 1 1.4 Greece (EL) 6 Estonia (EE) 50,157 60 91.5 Spain (ES) 2 Finland (FI) 212,135 7 6.9 Finland (FI) 7 France (FR) 2,665,302 16 15.6 France (FR) 16 Germany (DE) 6,501,815 3 4 Croatia (HR) 1 Hungary (HU) Greece (EL) 619,940 6 0 Ireland (IE) 0 Hungary (HU) N/A 0 26.6 Italy (IT) 1 Iceland (IS) 12,190 1,263 96.1 Liechtenstein (LI) 0 Ireland (IE) N/A 0 0.3 Lithuania (LT) 0 Italy (IT) 2,982,624 1 3.4 Luxembourg (LU) 0 Latvia (LV) 59,433 7 Latvia (LV) 7 Liechtenstein (LI) N/A 0 0 Netherlands (NL) 10 Lithuania (LT) 106,980 0 0 Norway (NO) 36 Luxembourg (LU) 21,058 0 0 Poland (PL) 1 Netherlands (NL) 750,000 10 10.7 Portugal (PT) 5 Norway (NO) 183,592 36 46.8 Romania (RO) 58 Sweden (SE) Poland (PL) 1,411,027 1 2.6 23 Slovenia (SI) 2 Portugal (PT) 379,487 5 10.9 Slovakia (SK) 0 Romania (RO) 412,431 58 90 United Kingdom (UK) 122 Slovakia (SK) N/A 0 0 Slovenia (SI) 177,166 2 3.5 0 20 40 60 80 100 120 Spain (ES) 1,714,696 2 0.4 Sweden (SE) 495,941 23 24.4 UK(NI) 43,541 122 140.4 22,803,696 10 11.39 36 ©2023 EDQM, Council of Europe. All rights reserved. Summary of Collections (2013 - 2022) 2023 SARE Exercise (2022 data) 50,000,000 40,000,000 30,000,000 20,000,000 6,376,960 15,576,875 10,000,000 0 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 Total 16,949,449 25,278,429 24,086,899 23,738,202 23,638,847 22,562,362 23,196,776 22,012,443 22,278,763 21,953,835 Apheresis collections 1,596,067 5,460,831 5,506,122 5,524,877 5,772,463 5,387,919 5,789,033 5,502,403 6,035,995 6,376,960 Whole blood collections 15,353,382 19,817,598 18,580,777 18,213,325 17,866,384 17,174,443 17,407,743 16,510,040 16,242,768 15,576,875 37 ©2023 EDQM, Council of Europe. All rights reserved. SAE by Type of Collection 2023 SARE Exercise (2022 data) 100% Country Whole blood Apheresis 2 collection collection 1 2022 2021 2022 2021 90% 2 1 1 Austria (AT) 6 9 Belgium (BE) 6 2 6 3 80% 4 6 1 Cyprus (CY) 6 70% Czechia (CZ) 1 Germany (DE) 5 6 4 10 60% Denmark (DK) 5 Spain (ES) 1 50% 1 6 1 3 64 4 3 1 1 Finland (FI) 6 3 2 33 5 France (FR) 13 1 6 19 40% 6 3 Ireland (IE) 20 11 9 7 13 20 Italy (IT) 1 3 1 30% 5 6 1 Netherlands (NL) 64 73 Norway (NO) 4 2 20% Poland (PL) 5 4 1 1 10% Portugal (PT) 1 12 1 1 Romania (RO) 33 35 2 1 0% Slovakia (SK) 3 Sweden (SE) 3 4 1 Slovenia (SI) 1 1 UK (NI) 1 1 Total 169 155 39 50 Whole blood collection (169) Apheresis collection (39) 38 ©2023 EDQM, Council of Europe. All rights reserved. Distribution of SAE by Country 2023 SARE Exercise (2022 data) N= 2 235 SAE by country (year 2021 & 2022) AT 9 11 BE 673 644 BG 1 CY 42 1 CZ 2 3 DE 189 259 DK 5 9 EE 30 47 EL 40 ES 26 7 FI 14 15 FR 418 468 HR 2 4 IE 154 133 IS 2 3 IT 30 10 LV 4 2 NL 78 81 NO 67 86 PL 20 37 PT 20 34 RO 238 688 SE 113 124 SI 3 6 Improved reporting? SK 3 (427 SAR in 2021 potentially UK 53 61 not reportable: component defect in donor selection, WB 0 100 200 300 400 500 600 700 collection, processing and testing) # SAE (2022) # SAE (2021) 39 ©2023 EDQM, Council of Europe. All rights reserved. Distribution of SAE by Activity Step 2023 SARE Exercise (2022 data) 952 (43%) of all SAE were reported under the Donor selection 242 activity step ‘Other’ and as SAE types instead of 11% Whole blood collection 169 activity step Other 952 7% Apheresis Collection 39 BE 586 43% 2% Testing 75 FR 156 3% Processing 58 DE 123 3% IE 32 Storage 247 IT 23 11% UK 22 Distribution 70 3% NO 5 Component DK 3 Issue 205 selection 127 9% PT 1 Compatibility 6% testing/cross-matching 51 PL 1 2% 0 100 200 300 400 500 600 700 Compatibility Donor Whole blood Apheresis Component testing / cross- selection collection Collection Testing Processing Storage Distribution selection matching Issue Other Total 2021 324 155 50 435 217 209 73 116 89 216 850 2734 2022 242 169 39 75 58 247 70 127 51 205 952 2235 40 ©2023 EDQM, Council of Europe. All rights reserved. SAE - Activity Step “Other” 2023 SARE Exercise (2022 data) SAE Category # SAE SAE Specification • Post-donation information (known by the donor at 273 Human error - Incorrect decision or omission following the correct procedure the time of donation) • Post-donation information (not known by the donor 313 Component defect at the time of donation) • Failure of IT systems 20 Equipment failure System failure - Inadequate process, procedure or documentation • Failure of the post-donation information (PDI) 9 Human error - Incorrect decision or omission following the correct procedure System failure - Other failure of the quality management system system • Loss of transfusion 25 Equipment failure Human error - Incorrect decision or omission following the correct procedure System failure - Other failure of the quality management system Not Activity • Transfusion delayed 8 Equipment failure Human error - Incorrect decision or omission following the correct procedure Steps, but System failure - Other failure of the quality management system SAE Types • Transfusion to wrong patients 66 Equipment failure Human error - Incorrect decision or omission following the correct procedure System failure - Other failure of the quality management system System failure - Staffing, workload or skill-mix • Transport of blood and blood components 28 Equipment failure Human error - Incorrect decision or omission following the correct procedure System failure - Other failure of the quality management system System failure - Staffing, workload or skill-mix • Materials 1 Component defect • Labelling 1 Human error - Incorrect decision or omission following the correct procedure • Other/s 208 Human error , System failure, Component defect, Equipment failure, Materials, Other 41 ©2023 EDQM, Council of Europe. All rights reserved. Distribution of SAE by Specification 2023 SARE Exercise (2022 data) Materials 18 1% Other 102 5% Human error 1099 49% Component defect 543 24% Equipment failure 216 10% System failure 257 11% Component Equipment System defect failure failure Human error Materials Other Total 2022 543 216 257 1,099 18 102 2,235 2021 1,037 243 332 974 21 127 2,734 42 ©2023 EDQM, Council of Europe. All rights reserved. SAE Type by Country 2023 SARE Exercise (2022 data) 100% 3 1 4 1 12 1 1 7 3 10 9 90% 2 8 3 7 1 1 2 1 80% 181 347 56 1 1 56 28 131 70% 16 2 60% 111 14 8 3 18 50% 1 42 2 5 4 3 2 4 52 25 10 21 40% 32 64 194 2 30% 42 103 22 319 1 1 4 8 1 107 20% 12 10% 26 4 1 10 2 1 43 1 6 1 1 3 3 0% Component defect Equipment failure System failure Human error Materials Other 43 ©2023 EDQM, Council of Europe. All rights reserved. Distribution of ‘Human Error’ Events 2023 SARE Exercise (2022 data) 0 50 100 150 200 250 300 Donor selection 142 Apheresis collection 15 Whole blood collection 60 Testing 27 Processing 30 Storage 92 Distribution 60 Component selection 95 Compatibility testing/Cross matching 40 Issue 147 Other(s) 76 Transport 9 Labelling 1 Failure of the post-donation information (PDI) system 7 Post-donation information… 273 Not Activity Loss of transfusion 6 Steps, but Transfusion delayed 2 SAE Types Transfusion to wrong patients 18 44 ©2023 EDQM, Council of Europe. All rights reserved. SAE Reporting 2023 SARE Exercise (2022 data) High variability among countries concerning: Sections in which information about SAE was Countries provided (#) a) Content (information to be provided): The information provided is largely incomplete (the Additional detail (if Comments event cannot be understood; lapidary); impact, available) / Comments cause and actions are provided extremely rare. Yes Yes 5 Yes No 11 and Not for all SAE reported No 4 b) where (what section of the webform); as seen, No No 4 No Not for all SAE reported 1 Situation partially explained by lack of clarity in the Common Approach and webform design Note: 5 countries reported no SAE 45 ©2023 EDQM, Council of Europe. All rights reserved.  2023 SARE Exercise (2022 data) Serious Adverse Reactions (in donors) 22 Countries: AT, BE, BG, HR, CY, CZ, DE, DK, EE, EL, ES, FR, IE, IS, IT, NL, NO, PL, PT, RO, SI and SE DENOMINATOR -Total number of collections : • 15,6 million whole blood collections • 6,4 million apheresis collections 46 ©2023 EDQM, Council of Europe. All rights reserved. SAR in Donors (2015 - 2022) 2023 SARE Exercise (2022 data) 7,769 7,658 8,000 7,000 6,239 6,000 4,635 5,000 4,025 3,821 4,000 2,946 2,935 3,000 2,000 1,000 0 2015 2016 2017 2018 2019 2020 2021 2022 When interpreting data on serious adverse reactions in donors, the following should be factored in: 1. Reporting of SAR in donors is voluntary. 2. Not all BE follow up on donors who experienced an adverse reaction. 47 ©2023 EDQM, Council of Europe. All rights reserved. SAR in Donors By Type of Collection 2023 SARE Exercise (2022 data) Austria (AT)(9) 4 Belgium (BE)(9) 5 1 8 N=2 935 Bulgaria (BG)(143) 143 Croatia (HR)(3) 3 Cyprus (CY)(14) 14 Czechia (CZ)(8) 8 Denmark (DK)(11) 8 3 Estonia (EE)(30) 30 France (FR)(1554) 1120 434 Germany (DE)(393) 328 65 Greece (EL)(56) 41 15 Iceland (IS)(6) 6 Ireland (IE)(5) 5 Italy (IT)(308) 203 105 Netherlands (NL)(6) 3 3 Norway (NO)(198) 20 178 Only countries that reported SAR 38 Poland (PL)(43) 5 in donors by type of collection Portugal (PT)(2) 2 88 were included. Romania (RO)(88) Slovenia (SI)(18) 18 Spain (ES)(1) 1 Sweden (SE)(30) 30 0 200 400 600 800 1000 Whole Blood Collection Apheresis Collection 48 ©2023 EDQM, Council of Europe. All rights reserved. Incidence of SAR in Donors 2023 SARE Exercise (2022 data) (per 100 000 collections) 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% N=2 946 Austria (AT) 1 1 Belgium (BE) 0.5 1.9 Bulgaria (BG) 84.7 Croatia (HR) 1.6 Cyprus (CY) 20.3 Czechia (CZ) 0.7 Denmark (DK) 2.53 4 Estonia (EE) 63.1 France (FR) 134 47.8 Germany (DE) 2.2 9.2 Greece (EL) 92 Iceland (IS) 53.2 Ireland (IE) 3.8 Italy (IT) 24.6 7.9 Netherlands (NL) 0.9 0.7 Norway (NO) 115 107 Poland (PL) 4.1 2.9 Portugal (PT) 0.7 Romania (RO) 21.7 Slovenia (SI) 21.9 Spain (ES) 0 Sweden (SE) 8 # of SAR per 100000 apheresis collections # of SAR per 100000 WB collections Same 22 countries as last year, except for Finland and Slovakia; fewer countries reported apheresis collections; incidence of SAR comparable to 2021 for AT, FR, DE, IT, SI, and SE. 49 ©2023 EDQM, Council of Europe. All rights reserved. * Only countries that reported SAR in donors by type of collection were included. Distribution of SAR in Donors 2023 SARE Exercise (2022 data) by Type of Reaction Apheresis Collection Whole Blood Collection (6.4 mil) (15.6 mil) Other (236) Other (108) 10% 16% Nerve injury/irritation (12) Nerve injury/irritation (156) 2% 7% Citrate reaction (21) Major cardiovascular event or 3% death (10) Vasovagal reaction (510) Major cardiovascular event or Vasovagal reaction ( 1869) 77% 1% death (7) 82% 1% Allergic reaction (6) 1% N=664 N=2 271 50 ©2023 EDQM, Council of Europe. All rights reserved. SAR in Donors – Additional Information 2023 SARE Exercise (2022 data) Country and SAR by Type of WB vs Apheresis SAR Rate SAR Type SAR # Gender Donor Donation Austria (AT) 44% (5) of reported SARs • 6 vasovagal reactions with vulnus lacero-contusum (9 SAR) occurred in whole blood • 2 vasovagal reactions with apnea donation and 55% (4) in apheresis donations. • 1 “other” SAR: thrombophlebitis France (FR) 58.3 SARs per 70% SAR in 71% SAR in 72% of reported SARs The 97 SARs reported in the category "Other“ in whole blood donors (1554 SAR IL 100,000 donations female donors regular donors occurred in whole blood include: (2,665,302 vs vs donation and 28% in 2-3) donations) or 9.8 30% in male 29% in first-time apheresis donations. - 54 hematomas SARs per 10,000 donors blood donors - 12 local pain blood donors Note: The incidence of SARs - 12 anaemias (1,593,206 in donors is higher in - 6 arterial punctions donors). apheresis (134 SARs reports - 3 localised infections / 100,000 apheresis donations (323,979 - 1 iron deficiency, and apheresis donations)) than - 9 uncategorised complications of donations (UCD). in whole blood donation (48 SARs reports/100,000 whole The 22 SARs reported in the category "Other“ in apheresis donors, are: blood donations (2,341,322 - 19 hematomas WB donations)). - 1 local pain, and - 2 uncategorised complications of donations (UCD). 51 ©2023 EDQM, Council of Europe. All rights reserved. SAR in Donors – Additional Information 2023 SARE Exercise (2022 data) cont. Country and SAR by Type of WB vs Apheresis SAR Rate SAR Type SAR # Gender Donor Donation Ireland (IE) (5 1 SAR in 27,986 60% (3) SAR in 80% (4) regular 100% (5) of reported • 2 cases of nerve injury on needle insertion (1 male and 1 female) SAR) attempted female donors donors SAR occurred in whole donations vs vs blood donation • 2 severe immediate vasovagal reactions with loss of consciousness (LOC), both of 130,911 attempted 40% (2) in male 20% (1) first-time whom sustained injury. whole blood donors donor - first-time female donor who had given a full donation and had LOC lasting < 60 donations and 9,018 attempted seconds without fitting or incontinence, but headaches for a week and concussion; full apheresis donations recovery a (total of 139,929 - regular blood donor; the LOC was associated with seizure-like movements; slow attempted recovery with hypotension and admission to hospital for 2 nights (intravenous fluids). donations). Donor investigated for an underlying CV cause, but none was found; full recovery. • 1 “Other” SAR - regular male donor, who donated without any apparent problems. He was well until 6 days after the donation when the donor developed pain in the antecubital fossa of the arm he had donated from. Condition deteriorated despite analgesia; donor diagnosed with septic arthritis (Staphylococcus Aureus) in the elbow joint that required hospitalisation, 2 surgical procedures under general anaesthesia and intravenous antibiotics; imputability = probable Luxembourg - - - 90% (178) of reported 20 SAR “Other” in WB group: (LU) SARs occurred in whole - local pain (13) (310 SAR) blood donation and 10% - other local reaction (6) (20) in apheresis - other systemic reaction (prolonged menstruation - 1) donations. 5 SAR “Other” in apheresis group: - local pain (4) - other systemic reaction (1 deep vein thrombosis in leg followed by lung thrombus) 52 ©2023 EDQM, Council of Europe. All rights reserved. SAR in Donors – Additional Information 2023 SARE Exercise (2022 data) Country and SAR # WB vs Apheresis Donation SAR Type Netherlands (NL) 50% (3) of reported SARs occurred No “other” SAR (6 SAR) in whole blood donation and 50% (3) in apheresis donations. 4 SAR nerve injury = venipuncture-related and/or thrombophlebitis Poland (PL) 88% (38) of reported SARs occurred 1 “other” SAR = vein and artery injury requiring (43 SAR) in whole blood donation and 12% treatment (5) in apheresis donations. Sweden (SE) Reports do not always specify “Other” SARs: (30 SAR) whether the event occurred during - 3 artery puncture whole blood donation or apheresis. - 3 painful haematoma - 1 migraine - 1 vasculitis - 1 haematoma after the bed’s armrest fell on the donor 4 additional SARs in donors occurred and were reported in 2022, but the cases were not closed at the time of this reporting: 1 suspected artery puncture, 2 nerve injury/ irritation + 1 vasovagal reaction. 53 ©2023 EDQM, Council of Europe. All rights reserved. SAR in Donors by Type of Reaction 2023 SARE Exercise (2022 data) Apheresis Collection 664 SAR in 2022 (684 SAR in 2021) Major CV 100% Other event or Nerve death up to 90% injury / Citrate Vasovagal Allergic 24h after Major cardiovascular irritation reaction reaction reaction donation Other 80% event or death up to 24h Country 2022 2021 2022 2021 2022 2021 2022 2021 2022 2021 2022 2021 70% after donation Austria (AT) 1 4 2 1 Allergic reaction Belgium (BE) 1 1 1 4 1 60% Czechia (CZ) 1 5 2 1 2 1 Germany (DE) 2 5 2 4 38 27 3 1 20 28 50% Denmark (DK) 2 1 1 8 1 Vasovagal reaction Estonia (EE) 1 40% France (FR) 4 6 7 19 395 384 2 2 4 2 22 32 Greece (EL) 1 14 30% Citrate reaction Croatia (HR) 1 Ireland (IE) 1 20% Iceland (IS) 6 Nerve injury / irritation Italy (IT) 1 9 10 35 34 3 2 57 50 10% Netherlands (NL) 2 1 1 1 4 6 Norway (NO) 1 2 2 13 18 5 5 0% Poland (PL) 3 3 1 1 1 Slovakia (SK) 3 Total 12 15 21 38 510 493 6 4 7 4 108 130 Only countries that reported SAR in donors by 2022: FR and DE reported 4 MCE; no fatalities in donors type of collection were included. 2021: CZ, FR, DE reported 4 MCE; no fatalities in donors 54 ©2023 EDQM, Council of Europe. All rights reserved. SAR in Donors by Type of Reaction 2023 SARE Exercise (2022 data) Whole Blood Collection 2 271 SAR in 2022 (2 262 SAR in 2021) Major cardiovascular 100% event or death up Nerve injury / to 24h after irritation Vasovagal reaction donation Other 90% Country 2022 2021 2022 2021 2022 2021 2022 2021 Austria (AT) 4 4 80% Other Belgium (BE) 4 6 4 8 10 70% Bulgaria (BG) 72 60 71 22 1 Cyprus (CY) 1 13 3 60% Czechia (CZ) 2 Major cardiovascular event or death up to 24h Germany (DE) 18 17 244 142 5 6 61 115 50% after donation Denmark (DK) 1 6 3 1 1 Estonia (EE) 30 5 40% Finland (FI) 1 Vasovagal reaction Spain (ES) 1 30% France (FR) 33 44 988 793 2 6 97 114 Greece (EL) 1 40 20% Croatia (HR) 202 3 3 Nerve injury / irritation 10% Ireland (IE) 2 6 2 5 1 3 Iceland (IS) 6 0% Italy (IT) 1 163 217 40 29 2 1 2 1 Slovenia (SI) (18) Estonia (EE) (30) Austria (AT) (4) Belgium (BE) (8) Spain (ES) (1) Greece (EL) (41) Poland (PL) (38) Italy (IT) (203) Germany (DE) (328) Norway (NO) (178) Portugal (PT) (2) Sweden (SE) (0) Cyprus (CY) (14) Ireland (IE) (5) Bulgaria (BG) (143) France (FR) (1120) Romania (RO) (88) Denmark (DK) (8) Netherlands (NL) (3) Croatia (HR) (3) Iceland (IS) (6) Netherlands (NL) Norway (NO) 14 6 144 106 20 18 Poland (PL) 1 6 30 34 7 6 Portugal (PT) 2 13 Romania (RO) 88 92 1 Slovakia (SK) 85 4 Sweden (SE) 3 6 18 30 1 9 6 Slovenia (SI) 3 1 15 13 2 Total 156 153 1869 1781 10 14 236 314 Only countries that reported SAR in donors by 2022: DE, FR, and HR reported 10 MCE; no fatalities in donors type of collection were included. 2021: BG, DE, FR, and SE reported 14 MCE; no fatalities in donors 55 ©2023 EDQM, Council of Europe. All rights reserved.  2023 SARE Exercise (2022 data) Annual comparison (Years of exercises 2013-2023): number of units issued/transfused/recipients (mil.) 60.00 50.00 40.00 30.00 20.00 10.00 0.00 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 Recipients transfused 3.60 3.22 4.19 4.25 3.13 3.52 3.26 3.23 3.17 2.91 3.03 Units transfused 13.35 16.56 21.43 21.44 20.91 20.67 19.31 19.33 18.88 17.81 16.96 Units issued 25.13 24.04 25.72 25.32 24.83 25.09 22.92 22.86 22.10 20.63 21.38 56 ©2023 EDQM, Council of Europe. All rights reserved.  2023 SARE Exercise (2022 data) Annual comparison (Years of exercises 2013-2023): SAR (1-3), SAR (2-3), SAE, SAR in donors and fatalities 16,000 14,000 12,000 10,000 8,000 6,000 4,000 2,000 0 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 Number of fatalities 22 22 27 25 16 28 20 26 24 25 27 SAR in Donors 2,494 2,470 3,723 7,769 7,658 4,635 6,239 3,821 4,025 2,946 2,935 SAE 2,953 2,972 4,460 2,338 2,599 2,920 2,770 2,604 3,018 2,734 2,235 SAR (IL 2-3) 1,831 1,739 1,410 1,349 1,737 1,871 1,636 1,674 1,756 1,379 1,516 SAR (IL 1-3) 3,519 2,831 2,441 2,587 2,950 3,114 2,512 2,625 2,967 2,814 3,216 57 ©2023 EDQM, Council of Europe. All rights reserved. Summary 2023 SARE Exercise (2022 data) Constant participation (30 countries; similar to the previous 2 years) The total number of reporting ES (3387 vs 3307) and number of units issued are comparable to 2021. However, due to under reporting of units transfused (> 5 mil. less reported in 2022), it can only be assumed that the magnitude of transfusion related activities was comparable to the previous years, but not at the level pre pandemic (2019). Reporting of denominators: 14 out 30 countries (47%) reported 100%, while (9 countries (30%) did not report the number of recipients; 17 countries out of 30 (57%) reported 100%, while 8 countries (27%) did not report the number of units transfused. No change in the types of reactions; the same proportion of the top four types of SAR: FNHR, anaphylaxis, TACO, and immunological hemolysis. Uncategorized reactions (Other) remain the most prevalent (27%). Potential inadequate classification (a constant issue throughout the years). SAR and fatalities rates are higher due to under reporting of the denominator. No relevant information provided for 27 out of 29 TTI (93%) apart from type of blood component and imputability level. Slight increase in the number of fatalities (27 vs 25 vs 24). Requirements for reporting fatalities in recipients as stated in the Common Approach largely not met 952 of all SAE (a 12% increase from 850 in 2021) were reported under the activity step ‘Other’, and as SAE types instead of activity step. Constant reporting of SAR in donors; good quality data. 58 ©2023 EDQM, Council of Europe. All rights reserved.  2023 SARE Exercise (2022 data) Next step • 2023 SARE exercise (data 2022) FINAL REPORT [email protected] 59 ©2023 EDQM, Council of Europe. All rights reserved.  Thank you for your attention Stay connected with the EDQM EDQM Newsletter: https://go.edqm.eu/Newsletter LinkedIn: https://www.linkedin.com/company/edqm/ Twitter: @edqm_news Facebook: @EDQMCouncilofEurope ©2020 EDQM, Council of Europe. All rights reserved. Saatja: <[email protected]> Saadetud: 03.01.2024 11:59 Adressaat: <[email protected]>; EDQM SARE-BLOOD <SARE- [email protected]> Koopia: <[email protected]> Teema: Preliminary results on SARE Blood 2023 (2022 data) exercise Dear competent authorities for blood and blood components, Please find attached the preliminary results of the SARE exercise on Blood 2023 (data 2022). We would appreciate if you could take a look and provide us your feedback on the data accuracy and the way of its interpretation until 02nd February 2024. Please do not hesitate to contact us or directly EDQM (in copy) for any question or doubt. Many thanks and kind regards, The SoHO team. European Commission DG SANTE (Health and Food Safety) Unit D2 Medical Products: quality, safety, innovationOffice address: Rue Breydel 2, 06/004, B-1049 Brussels/Belgium