1. 1 Country Report Iranian Blood Transfusion Organization F acts and Figures

2. 2 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

3. 3 Iran Country Profile Demographic & 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: $ 2017 Income Group per world bank classification: Lower middle income Human Development Index: Rank 99 out of 177 Exports: $63.18 bn; oil, gas, carpets, fruits, chemical, cars $= US

4. 4 Iran Country Profile Health 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)

5. 5 Iran Country Profile Demographic & Socioeconomic Indicators Adult (15 + ) Literacy rate: 82% (2004) M/F 87-76 Life expectancy: 70.3 years (2006) M/F 68.9- 71.8 Child mortality: M/F (per 1000) 42-36 Infant mortality: (per 1000) 28.6 HIV/ AIDS Prevalence: 0.04% HBV Prevalence: 3% HCV Prevalence: 0.4%

6. 6 Iran The Country

7. 7 Ministry of Health & Medical Education IBTO's High Council Managing Director Department of Legal Affairs Department of Public Relation & International Affairs Security OfficeOffice 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

8. 8 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.

9. 9 Blood Centers

10. 10 Blood Centers Zabol Isfahan

11. 11 Blood Centers QomRasht

12. 12 The Iranian Blood Transfusion Organization Major equipments and consumables are approved and procurement nationally Examples: Blood Bags Test Kits Refrigerated Centrifuges Automated Blood Grouping Machines ELISA Processors Blood Bank Refrigerators

13. 13 The Iranian Blood Transfusion Organization

14. 14 The Iranian Blood Transfusion Organization

15. 15 The Iranian Blood Supply system Whole blood is collected Only in IBTO blood centers Fixed centers Mobile (Factories, Offices, Universities)

16. 16 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

17. 17 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

18. 18 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.

19. 19 The Iranian Blood Supply system Type of Blood collected annually 100 %Volunteer Whole Blood Per- requestAutologous 0Replacement 0Directed

20. 20 The Iranian Blood Supply system 1.80 % average growth rate of Whole Blood collection (2000-2007)

21. 21 The Iranian Blood Supply system Per capita rate Blood Collection 24/1000 (06- 07) Collection rate age- eligible donors (18+) 36/1000 (05- 06)

22. 22 Regulation, Standardization and Certification IBTO constitution adopted in 1974 revised in 1984 is approved by the I.R of Iran ’ s Parliament The 2 nd version of IBTO standards titled » Iranian National Standards for Blood Transfusion «was published in 2005 and went in to effect in Sep. 2005

23. 23 Regulation, Standardization and Certification Registrations/ Certifications Obtained4 blood centers 2004ISO 9001-2000 ObtainedIBTO Diagnostic Reference Laboratory 2004ISO 15189-2003 In process Remaining BCs 2006-2008ISO 9001-2000

24. 24 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.

25. 25 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

26. 26 Recruitment of Blood Donors

27. 27 Recruitment of Blood Donors Demographic characteristics of Blood Donors 2006 Gender

28. 28 Recruitment of Blood Donors Demographic characteristics of Blood Donors 2006 Age

29. 29 Recruitment of Blood Donors Demographic characteristics of Blood Donors 2006 Education

30. 30 Recruitment of Blood Donors Demographic characteristics of Blood Donors 2006 Employment

31. 31 Recruitment of Blood Donors Demographic characteristics of Blood Donors 2006 Marital Status

32. 32 Amount of Blood Collected

33. 33 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)

34. 34 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

35. 35 Medical Assessment of whole Blood Donors

36. 36 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

37. 37 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

38. 38 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.

39. 39 Future changes in process

40. 40 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.

41. 41 On the Road to ISBT 128 Conversion

42. 42 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.

43. 43 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.

44. 44 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

45. 45 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.

46. 46 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 Replace ment donors Donations from Regular donors Lapsed donors New donors Per request 0.0%1%38.22%19.92%41.86%

47. 47 Laboratory Testing of Donated Blood Each unit of whole blood undergoes a standard battery of tests Required tests Total Units TestedBlood Grouping tests 100%ABO Grouping 100%RhD Typing

48. 48 Laboratory Testing of Donated Blood Total Units Tested Transmissible Disease Testing 100%Hepatitis B surface antigen (HBsAg) 100%Hepatitis C antibody (anti-HCV) 100%HIV 1 & 2 antibody-antigen (HIV Ab/Ag) 8%HTLV I, II antibody (anti- HTLV I, II) 100%Syphilis (RPR) 0.5%Malaria

49. 49 Laboratory Testing of Donated Blood Prevalence of marker of infection in blood donations in 2007 PercentageType of Infection 0.004%HIV 0.41%HBV 0.12%HCV 0.04%Syphilis 0.0%Malaria 0.02%HTLV

50. 50 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

51. 51 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

52. 52 Preparation and storage of components

53. 53 Preparation and storage of components

54. 54 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

55. 55 Clinical Uses of Blood Components PercentageBlood Issued in 2007 Total 2826194 1.45Whole Blood 52.9Red Blood Cells 20.2FFP 19.25Platelets (Random) 4.09Cryoprecipitated AHF

56. 56 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

57. 57 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.

58. 58 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

59. 59 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

60. 60 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

61. 61 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

62. 62 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

63. 63 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)

64. 64 Iranian Plasma Collection & Manufacturing Organization

65. 65