Iranian Blood Transfusion Organization Facts and Figures

Table of Contents History of blood transfusion 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

History of blood transfusion in Iran The first hospital of National Iranian oil company was established in Masjed Soleiman in 1924 and the blood transfusion was first carried out by the British Doctors in this hospital. Despite that the establishment of blood transfusion centers was not mentioned in the Constitution of the year 1948 of Iran Red Lion and Sun society (Red Crescent), regarding the goals set by the general director of the Group, including: 1- corpsmen, 2- the youth, 3- nurse training, 4- blood transfusion, this Group determined to establish blood transfusion center. From 1940s onward, blood transfusion has been sporadically done in various hospitals. Sina Hospital was one of the most significant centers of blood transfusion in Iran.

History of blood transfusion in Iran (con’t) 1948: Establishment of the First Private Blood Transfusion in Iran as Dr. Motamed blood transfusion center 1949: Publication of the First Notice to Call for Blood Donation 1950s: Hospitals started to use replacement blood 1952: Establishment of Army’s Blood Transfusion Center 1954: Establishment of the First Iran Red Lion and Sun society (Red Crescent) blood Transfusion Center 1955: Establishment of the First Center for preparation of Blood Derivatives 1955: Establishment of the First Provincial Blood Transfusion Center 1960s: The decade of 1960, conduced to valuable accomplishments for the activists of the blood transfusion medicine field in Iran. 1962: Establishment of the First Independent Iran Red Lion and Sun society (Red Crescent) Blood Transfusion Center.

History of blood transfusion in Iran (con’t) 1974: Establishment of National Blood Transfusion Organization 1976: Establishment of the First Provincial Blood Transfusion of Iran Blood Transfusion Organization 1978: Iran Blood Transfusion Organization & Islamic Revolution 1979:the Blood Transfusion Organization was assigned to the Ministry of Health and Welfare. 1980: Iran Blood Transfusion Organization & Imposing War Supply of blood and blood products required by the thousands of wounded soldiers 1984: Introduction of the Organization as the Sole Supervisor of the Supplying Blood and Blood Products in Iran

Screening tests 1974: HBs Ag Screening test 1987: HIV-Ab Screening Test 1997: HCV screening test 2005: Implementing HIV-Ab, HIV-Ag screening test 2006: Development of Iran Blood Transfusion Network 2006: Commencement of technical and software automation of Iran blood transfusion stations

The Iranian Blood Transfusion Organization 288 Total number of Blood Centers/ Blood Donation Centers 206 Blood Donation Centers 17 Blood Collection & Preparation Centers 65 Blood Centers 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.

The Iranian Blood Transfusion Organization

The Iranian Blood Supply system Whole blood is collected Only in IBTO blood centers Fixed centers Mobile (Factories, Offices, Universities)

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

The Iranian Blood Supply system Blood is provided to hospitals free of charge No 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

The Iranian Blood Supply system Type of Blood collected annually 100 % Volunteer Whole Blood Per- request Autologous Replacement Directed

The Iranian Blood Supply system 1.80 % average growth rate of Whole Blood collection (2000-2007)

The Iranian Blood Supply system Per capita rate Blood Collection 24/1000 (06- 07) Collection rate age- eligible donors (18+) 36/1000 (05- 06)

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

Regulation, Standardization and Certification Registrations/ Certifications Obtained 4 blood centers 2004 ISO 9001-2000 IBTO Diagnostic Reference Laboratory 2004 ISO 15189-2003 In process Remaining BCs 2006-2008

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.

Recruitment of Blood Donors 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

Recruitment of Blood Donors

Recruitment of Blood Donors Demographic characteristics of Blood Donors 2006 Gender

Recruitment of Blood Donors Demographic characteristics of Blood Donors 2006 Age

Recruitment of Blood Donors Demographic characteristics of Blood Donors 2006 Education

Recruitment of Blood Donors Demographic characteristics of Blood Donors 2006 Employment

Recruitment of Blood Donors Demographic characteristics of Blood Donors 2006 Marital Status

Amount of Blood Collected

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.

Future changes in process

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.

On the Road to ISBT 128 Conversion

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.

Tracing 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.

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

Disaster preparedness Is promoted by establishing IBTO Disaster Task Force to prepare policies and guidelines on blood needs during disasters. Readiness between IBTO and other relevant government organizations at the time of disaster is the aim.

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 2006 Total donation 1667412 Autologous donors Paid donors Family Replacement donors Donations from Regular donors Lapsed donors New donors Per request 0.0% 1% 38.22% 19.92% 41.86%

Laboratory Testing of Donated Blood Each unit of whole blood undergoes a standard battery of tests Required tests Total Units Tested Blood Grouping tests 100% ABO Grouping RhD Typing

Laboratory Testing of Donated Blood Total Units Tested Transmissible Disease Testing 100% Hepatitis B surface antigen (HBsAg) Hepatitis C antibody (anti-HCV) HIV 1 & 2 antibody-antigen (HIV Ab/Ag) 8% HTLV I, II antibody (anti- HTLV I, II) Syphilis (RPR) 0.5% Malaria

Laboratory Testing of Donated Blood Prevalence of marker of infection in blood donations in 2007 Percentage Type of Infection 0.004% HIV 0.41% HBV 0.12% HCV 0.04% Syphilis 0.0% Malaria 0.02% HTLV

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

Quality Control of Laboratory Testing National Internal Controls Central Quality Control Laboratory Blood group serology Positive and Negative controls Supplemental Tests HIV (Western Blot) or Line Immuno Blot / HIV P24 Ag / HIV-1 Ag confirm HTLV (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

Preparation and storage of components

Preparation and storage of components

Clinical Uses of Blood Components Establishment of Hospital Transfusion Committees in all medical centers that administer blood is in process Complications of transfusion Documentation, 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

Clinical Uses of Blood Components Percentage Blood Issued in 2007 Total 2826194 1.45 Whole Blood 52.9 Red Blood Cells 20.2 FFP 19.25 Platelets (Random) 4.09 Cryoprecipitated AHF

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

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.

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

Safety New Occupational Safety & Health Unit was established in 2000 IBTO’s policy is to emphasize on a safe workplace for the safety of the employees, donors, patient and visitors

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

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

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 centre Iranian blood transfusion organization-Research centre

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)

Iranian Plasma Collection & Manufacturing Organization