Laboratory Screening of Blood Units
In Iran, 100% of donated blood is screened for TTIs. Screening of donated blood for HBs-Ag has become 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.
According to the results of a country-wide research on the prevalence of HTLV, anti-HTLV I (and then Anti-HTLV I/II) became mandatory in seven provinces.
During 2009-2011, all main blood centers in provinces, which supply over 95% of the total blood supply in Iran, were equipped with ELISA automation system.
The prevalence rate of HBV and HCV in blood donors was 0.61 % and 0.13 % in 2005 respectively, which dropped to 0.116 % and 0.041 % in 2015. The prevalence rate of HIV in Iran in 2015 was 0.003 %. Various factors are contributed to the decline of TTI prevalence:
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 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 in headquarters.
Quality Control and Improvement
In transfusion medicine, quality evaluation of all equipment, raw materials, test kits, blood bags and reagents is essential prior - in blood transfusion centers. Therefore, the quality control departments are quite active to assess and evaluate the incoming items and final products in blood transfusion centers.
In -1996 with utilization of quality control laboratories in 8 provinces, training of quality control laboratories experts was accomplished in quality control laboratory of headquarters which led to development of activities in different centers.
In all main blood transfusion centers across the country, according to the national and international standards, 1% of each component should be evaluated monthly by Quality Control (QC) Department. The reports and results of quality control of components, and results of screening tests are sent to QC Department of -headquarters. In QC Department of - headquarters, all results are analyzed and processed in order to improve the quality and safety of processes of production in different departments of blood transfusion centers.
QC- Department of blood transfusion centers are responsible for release of incoming material, validation of freezing procedure, freezing and cold rooms, and maintaining cold chain of transportation of blood and blood components, and co-operation in internal audits .QC Department of headquarters is responsible for evaluation of test kits, blood bags, raw materials, reagents, tubes and equipment before tender as well as the release of all In Vitro Devices (IVDs) for every shipment
Other major activities of Quality Control Department of headquarters are as follows:
The establishment of quality assurance and GMP
In 1996, IBTO established the independent quality assurance system at the headquarters and provinces.
The quality policy of IBTO consists of following areas:
In all provinces the Quality Assurance Department were established during the recent decade and their responsibility are as follows:
1/ Controlling the document and records
2/ Monitoring and following the correction, corrective action, and preventive action
3/ Internal audit two times ayear
4/ Monitoring and assessing deviations, non-conformities, quality indicators, quality targets, and changes
5/ Supervision the training and re-training of the staff
In headquarters, since 2010, the Quality Assurance Department consisted of three different departments including Document Control Office, Validation Office and Process Control Office.
Document Control Department
The department e is responsible for - organizing, reviewing and archiving documents, hosting document control software, supervising the preparation of documents, controlling the records control and preparation of related documents.
Validation department is responsible to identify the process and validate them, to evaluate URS of technical software and approve them, to check the changes in current software by test case, to approve all validation processes including validation of cold and freezing room , to organize donation numbers all around Iran, and to prepare the related documents and etc.
Process Control Department
The department monitors, analyzes and provides feedback of all process of blood transfusion centers across the country including deviations, non-conformities, quality indicators, quality targets, changes, correction, corrective action, preventive action and etc.
In headquarters, it supervises internal audits, holds management review sessions, monitors corrective actions, preventive actions, deviations, training, qualitative goals, process indicators and utilization of new centers and relocated centers in provinces, organizes demographic information of centers all around Iran and prepares policies and quality manuals and other related documents.
After years of designing and implementing standards and quality assurance, , in 2011 IBTO received the ISO 9001-2008 quality management certificate for 52 blood transfusions centers and 38 blood collection and processing centers for three years.
In 2012 and 2013 –surveillance inspections were performed and certificates were renewed. Re-inspection was done in 2014 and the ISO 9001-2008 quality management certificates for all centers were renewed for the next 3 years.
Quality Control & Quality Assurance
- EMRO with the collaboration of IBTO and IRETM published The First Regional Status Report on Blood Safety and Availability
- IRETM and universities of Kurdistan regional government to collaborate on academic and educational areas
- Re-designation of IBTO as WHO Collaborating Center for 2017-2021
- Visit of IBTO Managing Director to Afghanistan Blood Service
- Three days international workshop on GMP in Blood Transfusion
- For the first time, blood transfusion on emergency helicopter saved the lives of wounded
- Tehran-Hanoi cycling tour in commemoration of World Blood Donor Day
- Opening Ceremony of Joint IRETM-UPEC Diploma Course on Management of Blood Transfusion Medicine
- Iranian Minister of Health: IBTO stands in the way of progress
- Training of Trainers workshop on Good Manufacturing Practices in blood transfusion