1 country report iranian blood transfusion organization f acts and figures
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Country Report
Iranian Blood Transfusion Organization Facts and Figures
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Table of Contents Iran- Country Profile IBTO Organizational Chart IBTO as a Centralized National Blood Program The Iranian Blood Supply System Regulation, Standardization and Certification Recruitment of Blood Donors Medical Assessment of Whole Blood Donors Laboratory Testing of Donated Blood Preparation and Storage of Components Clinical Uses of Blood Components Quality Assurance System Safety Education and Research Iranian Plasma Collection and Manufacturing
Organization
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Iran Country ProfileDemographic & Socioeconomic
Indicators
Population: 69,788,000 (68.38% urban 2006)
Population growth rate%: 3.1 (1990) 1.2% (2006)Total area: 1,648,000 sq. km Language: Farsi (official) Per capita GDP: $ 2017Income Group per world bank classification: Lower middle incomeHuman Development Index: Rank 99 out of 177Exports: $63.18 bn; oil, gas, carpets, fruits, chemical, cars
=$US
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Iran Country ProfileHealth Expenditure, Human and Physical
Resources Indicators
Total Health expenditure per capita: $ 131
Physician per 10,000 population:
8.9 (2005)Nursing and Midwifery
personnel per 10,000 population: 14.1 (2005)
Hospital beds per 10,000 population:
17.2 (2005)Population with access to
local health services (%): Urban/ Rural
100 (2005)
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Iran Country ProfileDemographic & Socioeconomic
Indicators
Adult (15+) Literacy rate: 82% (2004) M/F 87-76 Life expectancy: 70.3 years (2006) M/F 68.9- 71.8Child mortality: M/F (per 1000) 42-36Infant mortality: (per 1000) 28.6HIV/ AIDS Prevalence: 0.04%HBV Prevalence: 3%HCV Prevalence: 0.4%
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Iran The Country
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Ministry of Health & Medical Education
IBTO's High Council
Managing Director
Department of Legal Affairs
Department of Public Relation &
International Affairs
Security Office Office of Activity Evaluation & Complaints
Managing Director Office
Deputy of Financial &
Administration
Deputy of Technical &
Quality Assurance
Deputy of Research&
Education
Provincial Blood Centers
Recruitment Department
Organizational Chart
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The Iranian Blood Transfusion Organization
Total number of Blood Centers/ Blood Donation Centers
288
Blood Donation Centers206
Blood Collection & Preparation Centers17
Blood Centers65
Provincial Centers 30 Regional & Educational Centers 9
Blood donation center: Responsible for the collection of blood and associated activities for donor recruitment and recall, assessment of donor suitability and donor care.Blood Collection & Preparation Centers: Responsible for recruitment, blood collection, processing, storage & distribution.
Blood center: Carries out donor recruitment, blood collection (whole blood and in some cases, apheresis), testing for transfusion- transmissible infections and blood groups, processing in to blood components, storage, distribution to other blood centers and hospital blood banks within a defined region, the clinical use of blood and surveillance of adverse transfusion events.
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Blood Centers
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Blood Centers
Zabol Isfahan
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Blood Centers
Qom Rasht
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The Iranian Blood Transfusion Organization
Major equipments and consumables are approved and procurement nationallyExamples: Blood Bags Test Kits Refrigerated Centrifuges Automated Blood Grouping Machines ELISA Processors Blood Bank Refrigerators
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The Iranian Blood Transfusion Organization
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The Iranian Blood Transfusion Organization
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The Iranian Blood Supply system
Whole blood is collected Only in IBTO blood centers
Fixed centers Mobile (Factories, Offices, Universities)
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The Iranian Blood Supply system
Blood centers are nonprofit and governed by a director appointed by the IBTO’s Managing Director
Major function is to provide the community’s blood supply and hospitals within the blood collection area and hospitals in other areas as well
Area covered is determined by Historical factors An overall plan by Central Technical & QA
Department
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The Iranian Blood Supply system
Blood is provided to hospitals free of chargeNo charges or fees are requested for the cost of collecting, testing, processing, storing and shipping the blood
Central Immunohematology Reference Laboratory provides advance techniques for serological investigations on donors / patients
Produces home made panel cells to be used by the Blood Centers
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The Rare Blood Donor Program
Screens for Rare Donor Bloods to be frozen for thalassemia patients and other rare blood type patients/ Used for panel cell production.
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The Iranian Blood Supply system
Type of Blood collected annually
Volunteer Whole Blood100 %
AutologousPer- request
Replacement0
Directed0
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The Iranian Blood Supply system
1.80 % average growth rate of Whole Blood collection (2000-2007)
1200000
1300000
1400000
1500000
1600000
1700000
1800000
2000 2001 2002 2003 2004 2005 2006 2007
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The Iranian Blood Supply system
Per capita rate Blood Collection 24/1000 (06- 07) Collection rate age- eligible donors (18+) 36/1000
(05- 06)
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Regulation, Standardization and Certification
IBTO constitution adopted in 1974 revised in 1984 is approved by the I.R of Iran’s Parliament
The 2nd version of IBTO standards titled »Iranian National Standards for Blood Transfusion «was published in 2005 and went in to effect in Sep. 2005
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Regulation, Standardization and Certification
Registrations/ Certifications
ISO 9001-20004 blood centers 2004Obtained
ISO 15189-2003
IBTO Diagnostic Reference Laboratory 2004
Obtained
ISO 9001-2000Remaining BCs 2006-2008In process
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Regulation, Standardization and Certification
Technical & QA Deputy acts as National Regulatory Authority
Standard Operating Procedures (SOPs) are in use in all Blood Centers
Establishment of all Blood Centers/ Blood Donation Centers is required to be approved by IBTO’s Higher Council. Licenses are issued by Central Technical & QA Department before any facilities are operative renewed annually.
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Recruitment of Blood Donors
Blood Donor Recruitment strategies A national recruitment department Director of recruitment department
leads the related activities Lectures, media printed/ visual,
community social activities etc. A system of pre-donation counseling of
blood donors exist
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Recruitment of Blood Donors
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Recruitment of Blood Donors
Demographic characteristics of Blood Donors 2006 Gender
Total Whole Blood Donors
Women; 8.1
Men; 91.9
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Recruitment of Blood Donors
Demographic characteristics of Blood Donors 2006
Age
41- 50 yrs 18.8
51-60 yrs 7.2
> 60 yrs 0.8
< 20 yrs 7.2
21- 30 yrs36.9
31-40 yrs 29.1
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Recruitment of Blood Donors
Demographic characteristics of Blood Donors 2006 Education
High school not completed; 34.7
High School Diploma; 38.7
Higher Education; 2.2
Illiterate; 2.6
Associate Degree; 8.5
B.S Degree; 13.3
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Recruitment of Blood Donors
Demographic characteristics of Blood Donors 2006
Employment
Unemployed 3
Farmer 1.8
Factory employee 4.8
Civil employee 4.5
Service Personnel 3
Government employee
26.6
High school Student
2.7
Home maker 5.7
Self employed 41.6
College student 6.5
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Recruitment of Blood Donors
Demographic characteristics of Blood Donors 2006
Marital Status
Marital Status
Unmarried; 28.2
Married; 71.8
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Amount of Blood Collected
Number of Units of Blood Collected by IBTO1974 - 2005
0
300000
600000
900000
1200000
1500000
1800000
1974
1976
1978
1980
1982
1984
1986
1988
1990
1992
1994
1996
1998
2000
2002
2004
Year
Un
it
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Medical Assessment of whole Blood Donors
To ensure the safety of the donor and to obtain a high quality blood component that is as safe as possible for the recipient there is a complete pre donation screening in place
The emphases is on volunteer blood donation A complete medical history is obtained by a trained
physician before donation A brief physical examination before donation is conducted The donor’s identity is checked against a local Blood
Center deferral registry (Nation wide deferral registry is in process of being implemented by a new computer donor registry system)
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Medical Assessment of whole Blood Donors
Use of the confidential donor deferral system by which the donor can confidentially in private designate his/her unit as unsuitable for transfusion is in place
Individuals may donate not more than 4 times a year (every 8 weeks interval)
Donor is given information (Poster/Brochures) about Blood donation Transmissible disease testing Factors or behavior that would preclude blood donation Action that will be taken in the event of a positive test
result for a transmissible disease
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Medical Assessment of whole Blood Donors
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Medical Assessment of whole Blood Donors
A physician interviews the donor in complete privacy and direct questioning
Medical history Assesses the donor’s general condition Asks specific sex-related questions Informed consent
A written informed consent from the prospective donor is required
Blood donor medical history questionnaire
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Medical Assessment of whole Blood Donors
The volume of blood collected should be between 405 and 495 ml (450 ml±10%)
Nationally 18.9% of donors were deferred after being assessed as unsuitable to donate blood in 2007
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Future changes in process
Total Laboratory Automation will be implemented in regional IBTO Blood Center in order to centralize the testing of the donated blood.
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Future changes in process
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On the Road to ISBT 128 Conversion
Internationally recognized Barcode System ISBT128 will replace the old system. Tracking of specimens, test results and individual components is done by computers using these labels.
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On the Road to ISBT 128 Conversion
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Implementing new software system
IBTO is in the process of implementing the use of a single Organizational Wide Software System “MAK System” in all its blood centers through out the country.
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Tracking Blood Electronically
Recipient Tracing
There is a process of recipient tracing (Look-
Back) in IBTO by making sure that records
(Manual & semi- manual) are carefully
reviewed, in order to identify the patients who
have received seronegative blood from a donor
later found to be infected by blood borne
pathogens.
The Use of a single National Computer Network
System is an effort to make sure that, the
current look back process work more efficiently.
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Cord Blood and other cellular therapies
Establishment of a National Public Cord Blood Bank based on National & International standards and to be
accredited internationally (Net Cord) is in process
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Disaster preparedness
Is promoted by establishing IBTO Disaster Task Force to prepare policies and guidelines on blood needs during disasters.Readiness between IBTO and otherrelevant government organizations at the time of disaster is the aim.
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Medical Assessment of whole Blood Donors
Blood containers Blood is collected in to FDA or CE licensed
container (450±10% plus 63 ml CPDA)
Number of Whole Blood collected in 2006Total donation 1667412
Donations fromFamily Replace
ment donors
Paid donor
s
Autologous donors
New donors
Lapsed donors
Regular donors
41.86%19.92%38.22%1%0.0%Per request
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Laboratory Testing of Donated Blood
Each unit of whole blood undergoes a standard battery of tests
Required tests
Blood Grouping testsTotal Units Tested
ABO Grouping100%
RhD Typing100%
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Laboratory Testing of Donated Blood
Transmissible Disease TestingTotal Units
Tested
Hepatitis B surface antigen (HBsAg)100%
Hepatitis C antibody (anti-HCV)100%
HIV 1 & 2 antibody-antigen (HIV Ab/Ag)100%
HTLV I, II antibody (anti- HTLV I, II)8%
Syphilis (RPR)100%
Malaria0.5%
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Laboratory Testing of Donated Blood
Prevalence of marker of infection in blood donations in 2007
Type of InfectionPercentage
HIV0.004%
HBV0.41%
HCV0.12%
Syphilis0.04%
Malaria0.0%
HTLV0.02%
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Quality Control of Laboratory Testing
External controls WHO BBI Lab Quality Finland Acro-Metrix The Netherlands, NRL Australia
EQAS collaboration Run Control Samples (go- no-go samples)
IBTO Central QC laboratory sends samples to provincial Blood Centers
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Quality Control of Laboratory Testing
National Internal Controls Central Quality Control Laboratory Blood group serology Positive and Negative controls
Supplemental TestsHIV (Western Blot) or Line Immuno Blot / HIV P24 Ag / HIV-1 Ag
confirmHTLV (Western Blot)HCV (Riba) HBsAg (Neutralization)/ (HBcAb)RPR (FTA- ABS)
There are specific and clear Strategies (Algorithms) set by Technical and QA department to be used by laboratories for all screening test results
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Preparation and storage of components
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Preparation and storage of components
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Clinical Uses of Blood Components
Establishment of Hospital Transfusion Committees in all medical centers that administer blood is in process
Complications of transfusionDocumentation, follow up and reports of infectious and noninfectious complications of blood transfusion needs to be improved
Biovigilance Efforts are underway to establish a
national biovigilance system to collect and analyze data regarding transfusion related adverse events
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Clinical Uses of Blood Components
Blood Issued in 2007
Total 2826194
Percentage
Whole Blood1.45
Red Blood Cells52.9
FFP20.2
Platelets (Random)19.25
Cryoprecipitated AHF
4.09
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Quality Assurance System
A Quality Assurance management system has been implemented in IBTO
Standards from ISO 9001- 2000, AABB Quality System Essentials, European Council and WHO Quality Recommendations are used as guidelines
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Quality Assurance System The goals of the IBTO quality assurance system program
are to: Decrease errors Obtain credible results consistently Improve product safety Improve product quality
A QC department exist in each Blood Center with a QC officer in charge
QC department monitors all processes that take place in IBTO, from donor recruitment, donor selection, blood collection, distribution of blood and blood components, donor testing, labeling, storage, compatibility testing etc.
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Quality Assurance System Hospital blood banks
All hospital blood banks are monitored by IBTO’s Blood Center QC department and hospital inspector, periodically.
A comprehensive Quality Directive for hospital blood banks in cooperation with the Ministry of Health and Medical Education is in place
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Safety New Occupational Safety & Health Unit was established
in 2000IBTO’s policy is to emphasize on a safe workplace for the safety of the employees, donors, patient and visitors
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Education & Research Deputy of Research and Development is
responsible for National & International Educational programs
34 Faculty members of the Research Center provide teaching and training including basic scientific research in the field of transfusion medicine in cooperation with other IBTO scientific investigators in the country
An educational program leading to a master degree is offered by educational department for 7 students holding B.S. degree annually
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Education & Research IBTO’s technical & scientific materials in
transfusion services have been provided for neighboring Persian speaking countries through collaboration with WHO office in Cairo EMRO
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IBTO Research Center 2003
IBTO-Research Centre has published more than 70 specialized educational pamphlets and 20 books about blood transfusion, blood safety, and transfusion sciences in Farsi language in last 4 years.
IBTO-Research Centre embarked on publishing its
specialized quarterly entitled “Khoon” (Blood) that is indexed by IMEMR and Index Copernicus.
We forward copies of all our pamphlets, books, and journals to WHO and EMRO so as to be used in Farsi-speaking communities (such as Afghanistan). IBTO hopefully won the status of being a WHO Collaborating Center.
Iranian blood transfusion organization-Research centreIranian blood transfusion organization-Research centre
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Iranian Plasma Collection & Manufacturing
Organization There is a national strategy for the
provision of plasma derived products Iranian Blood Research and
Fractionation Center a public/ not for profit fractionation center has been built in Tehran which is being upgraded
At present, Plasma derivative products are imported from abroad as contract fractionation (Octapharma Austria and Biotest Germany, Kedrion Italy)
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Iranian Plasma Collection & Manufacturing
Organization
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