Quality Control & Quality Assurance

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:

  • 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;

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:

  • Preparation and sending of external quality control samples four times a year for screening tests (HBsAg, HIV Ag/Ab and Anti-HCV), confirmatory tests for HCV and HIV, blood grouping (Reverse and forward), total protein, HB, Hct, Hemolysis Index, and FVIII from the next year. 
  • Monitoring the results of quality control of blood and blood components,  results of screening tests done by ELISA and monitoring statistical data, especially the results of donors screening tests
  • Materiovigilance for blood bags, test kits, test tubes, anti-sera and disposable materials.
  • Cooperation in inspections of blood transfusion centers, blood collection and processing centers, and blood collection centers.
  • Holding training workshops for the heads of provincial quality control laboratories across the country at the beginning of their job annually, including training of cold and freezing rooms validation, plasma freezing process validation, calibration of centrifugation, semi-automatic pipettors, spectrophotometer, and etc. 
  • Establishing the Safety and Occupational Health Department  - at headquarters and holding workshop for the provincial heads of mentioned departments from all over the country;
  • Preparation of all necessary SOPs, WOIs, checklists and guidelines relating to quality assessment, reporting and improving processes;
  • Collaboration with health reference laboratory for quality control of diagnostic kits for hepatitis, HIV and HTLV and cooperation with the Food and Drug Organization;

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:

  1. Organization and leadership
  2. Facilities, Work Environment, Safety and Occupational Health
  3. Human resources
  4. Customers focus
  5. Suppliers and materials management
  6. Equipment management
  7. Process management
  8. Documents and records.
  9. Information Management
  10. Management of nonconforming events
  11. Monitoring and assessment
  12. Process improvement

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

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.