The Message of Managing Director of Iranian Blood Transfusion Organization (IBTO) Today blood, blood components and plasma derived medicines are vital parts of the modern medicine and health care systems. Without blood and its components, saving lives of a large number of patients such as mothers, children and would be impossible. Transfusion Medicine has a long history in Iran. For more than three decades and after the establishment of Iranian Blood Transfusion Organization (IBTO), all related activities including collection, quality control, surveillance and distribution of blood have been centralized and supervised by Ministry of Health (MOH). During the past three decades, IBTO has achieved remarkable successes the greatest of which, in recent years, was recording 100% voluntary non-remunerated blood donation in 2007. Cultural and religious beliefs of Iranians not only led IBTO to the above goal and index of 25 donations per 1000 population, but also ranked Iran as a pioneer nation in Eastern Mediterranean Region (EMR). Collecting more than 1.9 million units of blood in 2010, applying an integrated quality assurance system and use of latest technologies in preparation of blood and blood products brought up IBTO as one of the prominent organizations in Asia. Through a suitable allocation of resources, Iranian health system has enabled IBTO to provide all patients with nationwide gratis products; hence, all patients are under umbrella of the service. Iranian health system covers all the hemophilia and thalassemia patients with free of charge medicines and treatments. Since 2005, Iranian health system has initiated a project to meet all Iranian needs for plasma-derived medicines based on donated plasma by Iranian donors; although, the long term purpose of the program is to establish a plasma fractionation center, most of the needs of pharmaceutical market have been met by fractionation contracts with European partners. Regular audits by well-known international institutes are another verification fact to guarantee the quality of the products. I am extremely pleased to have had the opportunity to be a member of the huge family of IBTO and I hope the current booklet will brief readers in a convenient way. 3
Iranian Blood Transfusion Organization - IBTO 4 Persepolis-Shiraz Hafeziyeh-Shiraz 33 Pol- Isfahan Introduction Iran, a country with over 70 million populations, is one of the most populated countries of the Middle East. Over the past three decades, the government of Iran has substantially invested on primary and secondary health care and the country now has an advanced health system infrastructure. Demographic Indicators Area in square kilometers 1,648,195 Total population in thousands 73,650 % Urban population out of total population 71 Crude birth rate per 1000 population 18.7 Crude death rate per 1000 population 5.9 % Population growth rate 1.6 % Population below 15 years 25.1 % Population 65 years and over 5.2 % Dependency ratio 43.4 Total fertility rate (R) per woman 1.9
Today blood, blood components and plasma derived medicines are vital parts of the modern medicine and health care systems. The basic principles of blood safety are enough safe blood donors, a responsible blood transfusion service which can ensure appropriate and safe processing, testing, and appropriate use of blood. 5
Iranian Blood Transfusion Organization - IBTO 6 Blood bottle before 1970s Giving Blood before 1970s Blood Collection Center in 1980s Historical background A lthough blood transfusion in Iran has a long history, the new era of blood transfusion started in 1940s. As it was ratified in the 28th World Health Assembly of the World Health Organization (WHO), member states were urged to promote the development of national blood services based on voluntary non remunerated donation of blood. Fortunately, years before the ratification of mentioned resolution, Iranian Blood Transfusion Organization (IBTO) was established in 1974 and all blood transfusion related activities from donor recruitment to preparation of blood components and distribution of blood and blood products were centralized. Structure: The High Council of IBTO consists of professionals in blood transfusion science. Managing director of IBTO is selected by the High Council. The High Council of IBTO is the main policy maker in organizational chart, which is chaired by the Minister of Health (MOH).
Vision, Mission, Values and Responsibilities: IBTO is a public and non-profit organization that relies fully on the Iranian government for its budget and therefore supplies its products free of charge to both public and private hospitals. Vision: Our vision is to be a prominent internationally recognized organization, focused on improving health through advance science and practice of transfusion medicine. Mission: Our mission is to supply sufficient and safe blood and its components, in order to maintain and promote healthy lifestyle. Values: Obedience by laws, regulations and social values; Committed to provide a dynamic and reputable work environment for our staff; Maximizing our efforts to provide safe blood and blood components for all in need; Responsibilities: Modifying the standards of blood collection, screening, fractionation, storage and delivery of blood and blood components. Recruiting, maintaining and support voluntary donors through educational and non commercial promotional activities; Developing a blood supply network and blood collection centers across the country; Promoting national self-sufficiency in blood and plasma collections; Conducting necessary tests on donors and donated blood to ensure blood safety; Preparing blood components and delivering blood and its components to authorized health centers based on their requests; Holding training programs for health professionals involved in administration of blood and blood components; Applying the best to preserve the dignity and safety of blood donors; and Observing standards to dispose waste material. Activities: IBTO works in a number of specific areas ranging from recruitment of blood donors to distribution of blood unites among hospitals in the entire country. 7
Iranian Blood Transfusion Organization - IBTO 8 Step one - Blood Donor Recruitment Ibeen BTO implemented a long term plan to achieve 100% voluntary blood donation and has successful to achieve this goal and excluded all replacement donations since 2007. Trend of Blood Donation in Iran 1974-2010 Trend of Yearly Donation Index in Iran 1974-2010
These activities include: Raising public awareness about the importance of blood donation via media, elites and face to face training; Founding a central department in charge of planning for recruitment, training and retention of blood donors with 31 local offices across the country; Launching campaigns on importance of regular blood donation and high risk behaviors; Increasing the number of blood collection centers; Organizing blood drives in safe places; Training the staff on recruitment and retention of blood donors and developing partnerships with non-governmental organizations such as National Red Crescent Society (NRCS); Publishing brochures, books and CDs to promote blood donation, especially among the students and women; Adding certain topics on blood and blood donation importance to educational programs of primary school; Publishing and distributing of educational pamphlets for regular blood donors biannually. having implemented a short term iron supplementation program for female blood donors since 2006. Training session for students 9 2009 World Blood Donor Day
Iranian Blood Transfusion Organization - IBTO 10 Currently, 206 fixed blood donation sites are across the country which cover some 80% of blood.the rest is collected by mobile teams in work places, educational institutes and cities not served by fixed sites. In addition, the culture of making vows to donate blood in special religious holidays as well as prompt readiness of people to donate their blood during crisis such as natural disasters and wars have paved the way for IBTO to reach 100% voluntary non-remunerated blood donation. Shiraz Blood center Isfahan Blood center Blood donation during Ramadan Bushehr Blood center
Step Two - Select and Retain Safe Blood Donors Tsafeheand most important strategy to ensure a adequate supply of blood and its components is selection and retention of safe blood donors. Considering the spread of Transfusion Transmitted Infections (TTI), IBTO developed stringent criteria for selection of safe donors as follows: Founding blood collection centers at low risk places; Checking blood donors identity cards, before donation; Providing informative and educational materials about risk factors and the importance of safe blood donations in general population; Encouraging safer groups to donate; Screening via interviews, questionnaires and brief physical examinations done by trained physicians before donation; and call back after donation; 11
12 Iranian Blood Transfusion Organization - IBTO having implemented a uniform self-deferral procedure since 1997 and a confidential unit exclusion program since 2002; Excluding replacement donation while the increasing number of regular donations; Intensifying training efforts to increase public knowledge on TTI and improvement in automation system; Trend of Regular Blood Donation in Iran 2005-2010 CUE Desk
In order to maintain safe blood donors, IBTO implemented the following strategies: Establishing a computerized donor record system, kept in strictly confidential status; Providing appropriate blood donor care and donor recall, in cases of post-transfusion infections; Appreciating blood donors on some special occasions such as World Blood Donor Day and National Blood Transfusion Day; 13
Iranian Blood Transfusion Organization - IBTO 14 Step Three - Laboratory Screening of Blood Units IAgn has Iran, 100% of donated blood is screened for TTIs. Screening of donated blood for HBsbecame mandatory since the establishment of IBTO in 1974. Screening of blood units for HIV and HCV started since 1989 and 1996, respectively. In order to improve blood safety, anti-hiv I/II test was changed to HIV Ag/Ab in 2005. The prevalence of HTLV infection was evaluated in 1993 and according to the results of this research, anti-htlv I (and then Anti-HTLV I/II) became mandatory in seven provinces. During 2009-2011, most of the main blood centers in provinces, which supply over 95% of the total blood supply in Iran, were equipped with ELISA automation system. Prevalence of HBV, HCV & HIV in Blood Donations 2005-2010
The prevalence rate of HBV in blood donors was 0.61% in 2005, which dropped to 0.30% in 2009, with an overall prevalence rate of 0.44%. The overall prevalence rate of HIV infection in blood donors, during the last five years, was 0.004%. The prevalence of anti-hcv was 0.13% in 2005 and gradually, declined to 0.09% in 2009, with an overall prevalence of 0.12%, during this period. Various factors are contributed to the decline of TTI prevalence: Use of uniform regulations and standards, donor questionnaires, Standard Operating Procedures (SOPs), guidelines, testing kits, instruments, validation of procedures and training courses across the country; Use of high sensitivity and high quality screening tests and a uniform confirmation procedure; Technical capabilities of screening laboratories and external quality assessment; Regular audits and inspections, by internal auditors and external inspectors; 15
Iranian Blood Transfusion Organization - IBTO 16 NAT system is implemented in a pilot study in Tehran Province. An efficient look-back and haemovigilance system is now in progress to improve safety of blood and blood components. According to the national and international standards, 1% of each component should be evaluated monthly by Quality Control (QC) Department in each main blood transfusion center. The reports and results must then be analyzed and processed in order to improve in the quality of the production and preparation processes. To ensure blood safety, Quality Assurance (QA) and Quality Control (QC) departments monitor the effectiveness of all procedures involved in blood transfusion and evaluate the compatibilities of measures with national Standard Operating Procedures (SOPs). They also audit products and services regularly to detect the shortcomings and provide statistical analytical reports about the status of internal audits. Other main activities of the departments are assessing the efficacy of turnovers, recording and updating all documents to identify the possible sources of errors and following up the decisions taken about preventative and corrective actions. Each province has a separate QA and QC department which is responsible for mentioned activities and cooperates actively with central QC and QC centers.
Step Four - Processing Blood Components Tprocessing he use of blood component technology, enabled us to optimize blood usage and more patients benefit from a single blood donation. More than 98% of donated blood are processed to varieties of components. Iran has a large number of thalessemics and currently about 18000 thalessemics depend on IBTO to receive their needed fresh packed RBCs. Requirements for Blood and Blood Components Requirements for Blood and Blood Component Blood Component Indices Volume, Hemoglobin, Hemolysis index, Sterility testing, Whole blood Blood Clot Volume, Hemoglobin and Hematocrit, Hemolysis index, Packed RBC Sterility testing, Blood Clot Volume, Hemoglobin and Hematocrit, Hemolysis index, Washed RBC Sterility testing, Protein Leukoreduced RBC/Leukoreduced Blood Volume, Hemoglobin, Hemolysis index, Leukocyte count Volume, Swirling, Platelet count, Leukocyte count, RBC Platelet concentrate count, ph, Sterility testing Single Donor Platelet (Plateletpheresis ) Volume, Swirling, Platelet count, Leukocyte count, ph, Sterility testing Fresh Frozen Plasma (FFP) / Poor Plasma Volume, Factor VIII, Platelet count, Leukocyte count, Platelet (PPP) RBC count, Protein Blood and Blood Components (2010) RBC FFP Platelet CPP Cryo WRBC WB RBC: Red Blood Cell FFP: Fresh Frozen Plasma CPP: Cryo- Poor Plasma WRBC: Washed Red Blood Cell WB: Whole Blood 17
Iranian Blood Transfusion Organization - IBTO 18 There has been a considerable increase in production of RBCs (15.6%), Platelet Concentrates (30.8%), and Fresh Frozen Plasma units (35.8%) from 2003 to 2009. Newer components for special transfusions prepared by IBTO include leukoreduced whole blood, leukoreduced RBCs, irradiated blood, irradiated platelet concentrates, leukoreduced pooled platelets, and single donor platelet obtained by plateletpheresis. Trend of Blood and Blood Components 2005-2010
Step five - Release, Storage and Distribution Tsystem o optimize the quality of blood and blood components, a computerized monitoring is utilized to control the temperature and humidity in freezing rooms, cold room and the equipments used for storage of blood and blood components. IBTO uses the ISBT128 format for labeling all blood and blood products. Records of all donations and all blood products are captured in the IBTO computer system. All results of tests are also recorded in the computer system, which allows only suitable blood products to be released into the national blood inventory for transfusion. Donated blood which is unsuitable for use is immediately quarantined for disposal. All unsuitable units of donated blood are sterilized using a high pressure steam known as autoclave. 19
Iranian Blood Transfusion Organization - IBTO 20 Blood Supply Network IBTO distributes blood and blood components throughout the country, so the most remote areas in Iran have equal access to the same high- quality products as major cities do. A haemovigilance system has been set up in hospitals that use major part of blood and blood products. All health care staff including nurses and doctors as well as the staff of hospital blood banks have been trained to identify and manage adverse reactions of blood transfusion. Blood transfusion guideline for physicians
Hospitals use uniform forms for blood requests; monitor patients during blood administration, and report adverse reactions. In case of a blood transfusion reaction, the forms are filled and reported to the hemovigilance office at IBTO and a systematic workup is applied. The role of IBTO national reference laboratory for immunohematology includes: Introducing and using of molecular biology techniques to immunehematology testing; Maintaining the national frozen rare blood and member of ISBT Rare Blood Donor Working Party since 2010; Organizing a network of national registration of rare blood donors; Evaluating of blood grouping reagents produced, by Iranian Blood Research and Fractionation Center (IBRF); Preparing of blood grouping kits; Providing training courses in blood bank laboratory methods for: 1- Students of clinical laboratory science 2- Medical interns 3- Employees of blood banks 4- Staff of provincial blood collection centers 5- Employees of EMR s blood banks 21
22 Education and Research The most important goals that IBTO pursues through its research and education are to make all related staff informed on the most recent specialized scientific activities and developments in the fields of transfusion medicine and transfusion science. It also targets to raise knowledge of specialists, physicians, and paramedics about the developments. Iranian Blood Transfusion Organization - IBTO Education Department Education Department has succeeded to Establishing The High Institute for Research and Education in Transfusion Medicine, in 2007; Holding training courses including goal-oriented programs, workshops, and scientificspecialized seminars; Preparing scientific-specialized handouts, brochures and pamphlets aiming to upgrade the scientific and practical capabilities of IBTO s staff, at different levels; Holding Masters and PhD courses on hematology and blood banking; Getting involved in educational programs of medical and paramedical students, including residents and fellows; Holding the First and Second International Congress on Transfusion Medicine in 2007 and 2011, in valuable collaboration of ESTM, IPFA, ISBT, WHO-GCBS and two scientific seminars in joint endeavor of IBTO Research Center and France Blood Transfusion Organization (EFS) in 2007 and 2008. Research Department Goal setting and management of research projects, as well as preparation of necessary research grounds fall within the main scope of activities of research department. In order to reach a comprehensive development in research affairs in IBTO, a variety of measures including foundation of IBTO Research Center, research priority setting, publication of research results in international and local scholarly journals, planning to make research findings practical, authorship and translation of specialty books with the contribution of faculty members, specialists, physicians and experts have been made. Some of the highlights are: Conducting 260 research projects since 1996; Publishing 28 new books; Equipping a specialized library with the most up-to-date scientific resources.
IBTO Research Center IBTO Research Center was founded in 2003 for knowledge development in the field of transfusion sciences, orientation and coordination of research activities relevant to the supply of safe blood and blood components through conducting fundamental, epidemiologic and clinical research. The Programs have been organized to encourage researchers towards: 1- Blood transfusion topics; 2- Publication of The Scientific Journal of Research Center of Iranian Blood transfusion Organization aiming at encouraging and publishing the blood-related researches; 3- Planning to win the attention and cooperation of other local research and executive centers to promote the culture of blood donation; 4- Scientific cooperation with research and educational centers of other countries as well as international organizations 23
Iranian Blood Transfusion Organization - IBTO 24 Public Relations & International Affairs IBTO has a central public relations department with over 30 branches in regional blood centers. Public relations activities include: Awareness-raising among society, medical communities and target groups; Data recording and archiving related news, photos and movies; Keeping in touch actively with mass media and journalists through news conferences and also TV/radio interviews and programs); Holding the special ceremonies such as World Blood Donor Day and National Blood Transfusion Day; Preparing and distributing press releases, photographs or videos; Running a daily updated English-Persian website: (www.ibto.ir); World Blood Donor Day Organizing press briefings, exhibitions, visits, tours; In order to promote scientific and technical capabilities and cooperate more closely with international organizations as well as other foreign sister organizations, IBTO has increased its international activities since 2005. Main activities of International Affairs Department are: Planning and holding international conferences including:
- First Meeting of the Heads of Blood Transfusion Organizations of ECO Member Countries (Tehran, 23-24 June, 2008); - WHO/EMRO workshop on GMP in blood/plasma collection establishments (Tehran, 1-4 November, 2008); - Workshops on Voluntary Blood Donor Recruitment and Quality System for ECO Member Countries (Tehran, 10-12 May, 2010); Collecting and analyzing news and information about the recent activities of international organizations and countries in the field of blood transfusion; Conducting international research projects, such as setting up ECO Blood Safety Network. Drafting agreements with other countries (France, Venezuela, Indonesia, Sudan and Iraq); EFS-IBTO MOU First ECO Meeting International Experts visit from IBTO WHO-EMRO GMP Workshop 25 Workshop for ECO Member Countries
26 Other Activities: Plasma Fractionation Plasma derived products, including clotting factor VIII, factor IX, albumin and immunoglobulin (IG) are among life saving medicines and their availability is essential for treating patients in need of such medicines. In order to improve availability of these products, since 2004, IBTO has initiated a contract fractionation program with European fractionators for the surplus of recovered plasma produced in its blood collecting centers. Although, IBTO has used this project to improve national transfusion system, through upgrading its quality assurance systems, IBTO fractionation project has played a major role in improving availability of plasma-derived medicines in Iran. IBTO that receives over 1.7 millions donations from Voluntary Non-Remunerated Blood Donors (VNRBD) is able to produce about 300,000 liters of plasma annually. After meeting the demands of fresh plasma, some 150,000 liters could be reserved for fractionation Iranian Blood Transfusion Organization - IBTO Plasma Fractionated by IBTO every year. So far, IBTO has been able to increase the volume of the fractionated plasma to about 100,000 liters per year. Currently, this project is furnishing 100% of Iran s needs to the intravenous immunoglobulin
(IG) and factor IX. The share of the albumin and factor VIII produced by this project, in the country s market, are 18% and 10%, respectively. 27
Iranian Blood Transfusion Organization - IBTO 28 Iranian National Cord Blood Bank Iranian National Cord Blood Bank was established in May 2010. It is a public blood bank with the mission of providing stem cells for patients. Cord blood is collected according to ethical, scientific, and legal standards, after getting the consent of mother. Then, it is sent to the cord blood bank at IBTO headquarters. In cord blood bank, several tests are performed including determination of number and identity of the stem cells within the sample, as well as testing for viral and bacterial diseases in mother and cord blood. The process leads to separation of the nucleated cells and determination of HLA type is. The HLA type is registered in the HLA registry. The stem cells are mixed with appropriate preservatives and then stored in nitrogen tanks at -190 C.
The national cord blood bank stores stem cells and offers them to any patient in need; They are not stored for private purposes. Once, a physician makes a request, a HLA-matched cord blood is selected and forwarded to the transplant center. The center is expected to join with other cord blood banks around the world to build a strong network and inventory of high-quality cord blood units available for any patient who needs a transplant. 29
Iranian Blood Transfusion Organization - IBTO 30 Stem Cell Donor Registry Iranian Stem Cell Donor Registry (ISCDR) is a governmental organization, under the supervision of Iranian Blood Transfusion Organization (IBTO), established in 2009, in order to help patients who need Hematopoietic Stem Cell Transplant (HSCT). About 70% of patients rely on unrelated volunteer HLA-matched donors. We need to recruit donors, particularly from ethnic communities. A patient is more likely to be matched with a donor, from the same ethnic background. This increases the chance of a successful transplant. Main missions of ISCDR are: To provide the centralized information on the HLA phenotypes and other relevant data of unrelated stem cell donors in Iran for the benefit of the patients; To educate and recruit adequate potential HSC donors; To maximize the chance of finding suitable unrelated stem cell donors among Iranians; To minimize and coordinate the efforts, that required to find the suitable donors.
Information Technology: The information technology department of IBTO has initiated its activities since 1999. Main activities of this department are: Codification of comprehensive program of information technology and communication; Designing a home-made software, called Negareh, which is used to control all functions carried out through the whole procedure of blood transfusion from blood donation to distribution; Installation of video- conference system in 7 regional blood centers; Installation of wide area network connecting main center with other provincial centers around the country; Standardization of a server room; Installation of MAK System software with central and integrated database in Tehran; Designing the IP plan in all blood centers; Installation of stem cell registration system. 31