in the name of god blood safety s. amini kafi abad clinical and anatomical pathologist iranian blood...
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IN THE NAME OF GOD
Blood Safety S. AMINI KAFI ABAD
CLINICAL AND ANATOMICAL PATHOLOGIST
IRANIAN BLOOD TRANSFUSION ORGANIZATION(IBTO)
RESEARCH CENTERJune 2008
Viral Safety in Blood Transfusion
• Risk of transmitting infection to recipients has been drastically reduced in the past decades, due toa)Improved donor selection
b)Sensitive serologic screening assays
c)Application of viral inactivation procedures during manufacturing of cellular and plasma products
Donation must be accomplished in such a way that the safety of both
the donor and the potential recipient/ recipients is assured.
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Blood Safety Procedures (Excluding Laboratory Testing)
• Production
1.Exclusion of donor groups/donor sites
2.Elimination of donation incentives
3.Donor education
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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)
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.
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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.
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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.
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Health History Interview QuestionsCATEGORY DISEASE 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 treatment CJD
Sexual or drug use activities of donor or sexual partner (s)
AIDS, HTLV1/2, hepatitis
Previous residence in or visit to endemic area
Malaria
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Blood Safety Procedures (Excluding Laboratory Testing)
• Post-donation
1.Telephone call-back
2.Product retrieval
3.Recipient notification
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
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
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
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)
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Declining time to detection of HBV, HCV, HIV Declining time to detection of HBV, HCV, HIV markers during the window phase following infectionmarkers during the window phase following infection
Infection
HCV RNA HCV Ag
EIA 3.0
EIA 2.0
EIA 1.0
0 4 11 14 70 80 150 (days)
Infection
HIV RNA
p24 Ag
EIA 3.0
0 11 16 22 (days)
HCVHCV
HIVHIV
Infection
HBV DNA
EIA 3.0
0 31 41 56
HBVHBV
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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
Need to establish systems for traceability in blood transfusion
services
• LOOK BACK STUDIES
• TRACE BACK STUDIES
Trace Back StudyPatient with TTI
Blood transfusion history
Identifying the implicated component (s)
Reassess the donor (s)
Look back for other recipients
Monitor recipients for TTI
Look Back Study
Donor with TTI
Blood donation history
Identifying the implicated component(s)
Trace the recipient (s)
Assess for TTI
Principle
• Confidentially
• To detect, and collect information – A system to gather accurate information
– Overall effect is to improve transfusion safety and thus public confidence
Benefits
• Opportunity to take action and improve the overall safety and quality of transfusion practice
• Improved public confidence and trust