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IN THE NAME OF GOD Blood Safety

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

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IN THE NAME OF GOD Blood Safety

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

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

  3. Donor Selection

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

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

  6. 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) IBTO Research Center 7

  7. 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.

  8. 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.

  9. 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. IBTO Research Center 14

  10. Health History Interview Questions IBTO Research Center 15

  11. IBTO Research Center 17

  12. Blood Safety Procedures (Excluding Laboratory Testing) • Post-donation 1.Telephone call-back 2.Product retrieval 3.Recipient notification

  13. Donor Selection and Monitoring in Iran

  14. 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

  15. 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

  16. 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

  17. Screening Tests Serologic Tests NAT

  18. 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)

  19. Declining time to detection of HBV, HCV, HIV markers during the window phase following infection HBV DNA EIA 3.0 31 41 56 0 Infection HBV HCV RNA HCV Ag EIA 3.0 EIA 2.0 EIA 1.0 0 4 11 14 70 80 150 (days) Infection HCV HIV RNA p24 Ag EIA 3.0 0 11 16 22 (days) HIV IBTO Research Center 27 Infection

  20. HBV

  21. HCV

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

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

  24. 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

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

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

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

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