2. IN THE NAME OF GOD Blood Safety S. AMINI KAFI ABAD CLINICAL AND ANATOMICAL PATHOLOGIST IRANIAN BLOOD TRANSFUSION ORGANIZATION(IBTO) RESEARCH CENTER June 2008

3. Viral Safety in Blood Transfusion Risk of transmitting infection to recipients has been drastically reduced in the past decades, due to a)Improved donor selection b)Sensitive serologic screening assays c)Application of viral inactivation procedures during manufacturing of cellular and plasma products

4. Donor Selection

5. Donation must be accomplished in such a way that the safety of both the donor and the potential recipient/ recipients is assured.

6. IBTO Research Center6 Blood Safety Procedures (Excluding Laboratory Testing) Production 1.Exclusion of donor groups/donor sites 2.Elimination of donation incentives 3.Donor education

7. IBTO Research Center7 Blood Safety Procedures (Excluding Laboratory Testing) At donation site prior to donation 1.Self-exclusion in response to written material 2.Donor registration 3.Health history interview and examination 4.Donor deferral registry 5.Confidential unit exclusion (CUE)

9. Donor registration ID card Must allow full identification and link to donor to current and previous records. Current information with each donation. Must be possible to notify donor of any abnormalities in physical exam, medical history or post-donation laboratory tests. IBTO Research Center9

13. 13 Donor Processing Donor Physical –Basic physical and testing processes including Hematocrit, Blood pressure, Pulse, Temperature, and Weight. Donor Interview –Series of questions and guidelines to be reviewed by the donor and Blood Bank personnel.

14. IBTO Research Center14 Purpose of the Donor Interview and Physical Protect the Donor –Those aspects of the interview that are in place to protect the donor. Protect the Recipient –Those aspects of the interview that are in place to protect the recipient.

15. IBTO Research Center15 Health History Interview Questions CATEGORYDISEASE PREVENTED Medical history of a specific disease AIDS, hepatitis, malaria, Chagas disease, babesiosis, CJD Medical symptoms compatible with a specific disease AIDS, bacterimia, viremia Blood exposure by needle stick injury or blood transfusion AIDS, hepatitis Medical treatmentCJD Sexual or drug use activities of donor or sexual partner (s) AIDS, HTLV1/2, hepatitis Previous residence in or visit to endemic area Malaria

17. IBTO Research Center17

19. IBTO Research Center19 Blood Safety Procedures (Excluding Laboratory Testing) Post-donation 1.Telephone call-back 2.Product retrieval 3.Recipient notification

20. Donor Selection and Monitoring in Iran

21. Donor selection and monitoring in Iran Unique Organization Structure Uniformity of the entire rules, regulations and standards including questionnaires, SOPs, guidelines, forms, testing kits, blood bags, instruments and training courses in all blood transfusion services across the country Education efforts of IBTO and MOH to increase public's knowledge on blood borne infections and routes of transmission Interview by medical doctors, and directly question about behavioral habits and high risk behaviors

22. Donor selection and monitoring in Iran 1997: Mandatory uniform donor deferral criteria 1997: Self-deferral procedure before registration 1997: Donors are directly requested not to donate if they had AIDS-related symptoms, HIV- related risk behaviors and history of jaundice or viral hepatitis. 2002: Implementation of confidential unit exclusion (CUE) Increase in the number of voluntary and repeat donor

23. Donor selection and monitoring in Iran Decrease in number of replacement donations Usage of software in blood services Data registry of blood donors which allows the deferral of volunteers with a history of positive results Use of highly sensitive test kits Vaccination against HBV

24. Screening Tests Serologic Tests NAT IBTO Research Center24

25. IBTO Research Center25

26. Residual Risk of TTI After Screening Sources of residual risk Failure to test Human error (mislabeling, procedural) False negatives (equipment and reagents) Variants of known agents New agents for which no test available Unknown agents Immunosilent donor Window period donations * (Moore, et al., 2001)

27. IBTO Research Center27 Declining time to detection of HBV, HCV, HIV markers during the window phase following infection Infection HCV RNA HCV Ag EIA 3.0 EIA 2.0 EIA 1.0 0 4 11 1470 80150 (days) Infection HIV RNA p24 Ag EIA 3.0 0 11 1622 (days) HCV HIV Infection HBV DNA EIA 3.0 0 31 41 56 HBV

28. HBV

29. HCV

31. IBTO Research Center31 Window period reduction by PCR HIV HBV HCV Reduction 11 31-41 4-11 50 45-73 84-94 11 25-15 66-59 22 56 70 Window period (days) %DaysPCRSerologyVirus

32. Need to establish systems for traceability in blood transfusion services LOOK BACK STUDIES TRACE BACK STUDIES

33. Trace Back Study Patient with TTI Blood transfusion history Identifying the implicated component (s) Reassess the donor (s) Look back for other recipients Monitor recipients for TTI

34. Look Back Study Donor with TTI Blood donation history Identifying the implicated component(s) Trace the recipient (s) Assess for TTI

35. Principle Confidentially To detect, and collect information –A system to gather accurate information –Overall effect is to improve transfusion safety and thus public confidence

36. Benefits Opportunity to take action and improve the overall safety and quality of transfusion practice Improved public confidence and trust

37. IBTO Research Center37