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

Donor Selection

Donation must be accomplished in such a way that the safety of both

the donor and the potential recipient/ recipients is assured.

IBTO Research Center 6

Blood Safety Procedures (Excluding Laboratory Testing)

• Production

1.Exclusion of donor groups/donor sites

2.Elimination of donation incentives

3.Donor education

IBTO Research Center 7

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.

IBTO Research Center 9

IBTO Research Center 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.

IBTO Research Center 14

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 15

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

IBTO Research Center 17

IBTO Research Center 19

Blood Safety Procedures (Excluding Laboratory Testing)

• Post-donation

1.Telephone call-back

2.Product retrieval

3.Recipient notification

Donor Selection and Monitoring

in Iran

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

Screening Tests

Serologic Tests

NAT

IBTO Research Center 24

IBTO Research Center 25

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)

IBTO Research Center 27

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

HBV

HCV

IBTO Research Center 31

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

IBTO Research Center 37