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

1

Country Report

Iranian Blood Transfusion Organization Facts and Figures

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

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

4

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)

5

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%

6

Iran The Country

7

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

8

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.

9

Blood Centers

10

Blood Centers

Zabol Isfahan

11

Blood Centers

Qom Rasht

12


Major equipments and consumables are approved and procurement nationallyExamples: Blood Bags Test Kits Refrigerated Centrifuges Automated Blood Grouping Machines ELISA Processors Blood Bank Refrigerators

13


14


15

The Iranian Blood Supply system

Whole blood is collected Only in IBTO blood centers

Fixed centers Mobile (Factories, Offices, Universities)

16


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


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

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


Type of Blood collected annually

Volunteer Whole Blood100 %

AutologousPer- request

Replacement0

Directed0

20


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

21


Per capita rate Blood Collection 24/1000 (06- 07) Collection rate age- eligible donors (18+) 36/1000

(05- 06)

22

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

23


Registrations/ Certifications

ISO 9001-20004 blood centers 2004Obtained

ISO 15189-2003

IBTO Diagnostic Reference Laboratory 2004

Obtained

ISO 9001-2000Remaining BCs 2006-2008In process

24


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

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


27


Demographic characteristics of Blood Donors 2006 Gender

Total Whole Blood Donors

Women; 8.1

Men; 91.9

28


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

29


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

30



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

31



Marital Status

Marital Status

Unmarried; 28.2

Married; 71.8

32

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

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


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


36


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


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

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

Future changes in process

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

On the Road to ISBT 128 Conversion

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

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

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

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.

46


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

47

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%

48


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%

49


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%

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

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

52

Preparation and storage of components

53

Preparation and storage of components

54

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

55

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

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

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

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

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

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

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

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

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

Iranian Plasma Collection & Manufacturing

Organization

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

Documents

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