BLOOD DONATION OR BLOOD DONOR DEFERRAL BASED ON DATA ON NONCONFORMITIES DETECTED IN POST-SELECTION PERIOD (DURING AND AFTER BLOOD COLLECTION)

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1 BLOOD DONATION OR BLOOD DONOR DEFERRAL BASED ON DATA ON NONCONFORMITIES DETECTED IN POST-SELECTION PERIOD (DURING AND AFTER BLOOD COLLECTION) Tomislav Vuk Croatian Institute of Transfusion Medicine Zagreb CROATIA

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3 HOW IMPORTANT IS THE COMMUNICATION WITH BLOOD DONORS? Tomislav Vuk Croatian Institute of Transfusion Medicine Zagreb CROATIA

4 BLOOD DONOR SELECTION Important role in: quality assurance blood product safety donor health protection

5 SELECTION CRITERIA clearly defined all activities described in details in SOPs written questionnaire - standardization

6 QUESTIONNAIRE clear unambiguous reasonably detailed regularly revised NONCONFORMITIES RECORDED DURING AND AFTER COLLECTION!

7 DONOR EDUCATION selection criteria self-exclusion reporting of any information on a possible inappropriateness of the donated blood utilization in transfusion treatment

8 OBJECTIVES There is little literature data on the information learned from donors during and after blood collection, which were not detected or were kept back in the process of selection.

9 METHODS data of the Croatian Institute of Transfusion Medicine (CITM) Department of Quality Assurance donor-related nonconformities, based on information on the possible risks for blood donation, detected in the post-selection period (during or after blood collection) retrospective analysis nonconformity reports 10-year period ( )

10 R E S U L T S Nonconformity n % Elevated leukocyte count (complete blood count performed in whole blood donors to be included in the program of apheresis) Demonstrated or suspected infection (the agents routinely tested in donated blood excluded) Risky sexual behavior Blood donation for blood testing Drugs and vaccinations Alcohol intoxication Recent surgical procedure or invasive diagnostic examinations Sharing household or sexual affair with individuals suffering from viral hepatitis Skin diseases (including allergies) Mental illnesses Liver disease suspected, including viral hepatitis Tattoo, acupuncture, accidental needle pricks Demonstrated or suspected malignancy Other Total

11 RESULTS Total donor deferral rate: 11.4% ( %) 272 donor-related nonconformities during or after blood collection: 0.03% of donors presenting for blood donation 0,04% of blood donors donated blood

12 RESULTS FREQUENCY OF NONCONFORMITIES % 0,07 0,06 0,05 0,04 0,03 0,02 0, Increased WBC count excluded Total nonconformities

13 WBC (CBC) DETERMINATION 1. at the beginning of each apheresis procedure 2. WB donors candidates for apheresis program Increased WBC count: BP nonconformity donor notification

14 WBC-WB DONORS Elevated WBC count Total: 54 (M=36, F=17) WBC count available: 44 Upper limit: 9.70 WBC count N % % Donors Donations WBC count Age Average Range

15 APHERESIS PROCEDURES INTERRUPTED DUE TO INCREASED WBC COUNT % 3 2,5 Systematic NC recording 2 1,5 1 0, year

16 APHERESIS PROCEDURES INTERRUPTED DUE TO INCREASED WBC COUNT Donors: 119 Donations: Total: 173 (M=145, F=28) WBC count available:149 WBC count N % % 52%

17 APHERESIS PROCEDURES INTERRUPTED DUE TO INCREASED WBC COUNT M WBC count N % F WBC count N % % %

18 APHERESIS PROCEDURES INTERRUPTED DUE TO INCREASED WBC COUNT M F All Donors Donations WBC count Age Average Range Donors Donations WBC count Age Average Range Donors Donations WBC count Age Average Range

19 APHERESIS PROCEDURES INTERRUPTED DUE TO INCREASED WBC COUNT M F All Increased WBC count Donors N % Increased WBC count Donors N % Increased WBC count Donors N % 1 x x x x x x x x x x x x x x x Donors: 100 Donations: 145 WBC available: 124 Donors: 19 Donations: 28 WBC available: 25 Donors: 119 Donations: 173 WBC available: 149

20 RESULTS - INFECTIONS % 0,012 0,010 0,008 New questionnaire H1N1 0,006 0,004 0,002 0, Infections Linear (Infections)

21 RESULTS-INFECTIONS % 0,005 0,0045 0,004 0,0035 0,003 0,0025 0,002 0,0015 0,001 0, CITM subsequent % 0,009 0,008 0,007 0,006 0,005 0,004 0,003 0,002 0, revision of the questionnaire CITM subsequent

22 RESULTS-INFECTIONS 25 % common cold, virosis Influenza tick-borne diseases mononucleosis GI infections bacterial infections suspected malaria infected wounds other

23 RESULTS RISKY SEXUAL BEHAVIOUR N = 31 % 0,014 0,012 Project Anonymous and free testing for HIV Continuously 0,01 0,008 0,006 0,004 0, Risky sexual behaviour Linear (Risky sexual behaviour)

24 RESULTS RISKY SEXUAL BEHAVIOUR % % first two donations or more Number of donations

25 RESULTS RISKY SEXUAL BEHAVIOUR (%) uneasiness, embarrassment, lack of privacy? 0 promiscuity MSM sex with promiscuous person sex with a prostitute HIV+ partner other undefined

26 DONOR DATA N Mean No of donations Mean age N Mean No of donations Mean age Infections CITM Subsequent Total M F M F M F Risky sexual behaviour CITM Subsequent Total M F M F M F

27 C O R R E C T I O N S Nonconformity n % Elevated leukocyte count (complete blood count performed in whole blood donors to be included in the program of apheresis) Demonstrated or suspected infection (the agents routinely tested in donated blood excluded) Risky sexual behavior Blood donation for blood testing Drugs and vaccinations Alcohol intoxication Recent surgical procedure or invasive diagnostic examinations Sharing household or sexual affair with individuals suffering from viral hepatitis Skin diseases (including allergies) Mental illnesses Liver disease suspected, including viral hepatitis Tattoo, acupuncture, accidental needle pricks Demonstrated or suspected malignancy Other Total

28 CONCLUSION Donor-related nonconformities: 1. Failures in the process of donor selection 2. Communication with donors during the blood donation

29 CONCLUSION Increased WBC count: - appropriateness of the current procedure? - repeatedly elevated WBC count: detailed anamnesis (physiological/pathological condition?) - predonation screening (capillary blood)? Suspected infection: - revision of the questionnaire: acute and chronic infections - temperature measurement? Risky sexual behaviour: - information about the possibility of free and anonymous testing (leaflets, posters, questionnaire..) - education (testing limitations: window period, STD transmission...)

30 CONCLUSION further improvement of the questionnaire (additional questions or explanations of particular conditions and diseases): - liver diseses - alcohol intoxication - sharing household or sexual affair with individuals suffering from viral hepatitis - tick-borne diseases inclusion of this category of nonconformities as a quality indicator communication with blood donors donor education

31 THANK YOU!