Program Activities-Research

2013/05/03
單圖版圖片 Program Activities-Research

 

Assessment by Taiwan FDA
Taiwan Food and Drug Administration conducted assessment, during September through December 2011, on the blood centers, donor rooms and mobile collecting sites of TBSF that collect plasma for further manufacturing. The assessment was carried out for the procedures in collection, preparation, testing and storage of plasma for further manufacturing. The assessment was completed and TBSF was found in compliance with GMP requirements.
Accreditation by TAF
The laboratories in TBSF Head Office, Taipei Blood Center, and Kaohsiung Blood Center had been certified by Taiwan Accreditation Foundation (TAF) in the field of medical testing in 2012.
Accreditation by ISO
TBSF has achieved ISO 9001 accreditation since 2001. Procedures for blood collection and preparation were executed with strict observance to operation manual. An internal network system is used in the control of documents within TBSF. Internal audit and management review are held each year to guarantee the quality assurance system.
Blood Safety
To minimize risks of infections through blood transfusion, we have implemented NAT testing for selective donations since 2010. On the end of 2012, Taiwan Department Of Health passed the required procedures to cover NAT expense through the budget of National Health Insurance. NAT was introduced as a routine for donation screening since January 2013.
Laboratory Testing
The blood tastings, ABO and infectious diseases, are performed at Taipei and Kaohsiung blood centers with the testing capacity of 6,000 specimens per day. Fully automated instruments, such as Tecan Genesis RMP, PK7300, AU2700, VITROS ECi, Abbott AxSYM, and CHIRON TIGRIS, are used to detect transfusion-transmitted viruses, syphilis, ABO/Rh D blood types and biochemical testing. Testing results are transferred to each blood centers through an internal web system for final labeling of blood and blood components.
To ensure the accuracy of lab testing, we has actively taken part in proficiency programs including those provided by College of American Pathologists (USA), American Society for Histocompatibility and Immunogenetics (USA), National Serology Reference Laboratory (Australia), and those by Taiwan Society of Laboratory Medicine as well. The consistency of our laboratory testing has met the approval standards.
Reference Laboratory
The reference laboratory, since its establishment, has assisted hospitals in solving clinical problems associated with blood transfusion and provided education related to blood safety. Since the aging of donor population and the increase of immigrants, demands for rare bloods are increased. In this year, work continued to detect donors for RBC antigens. Currently, we have maintain over 40,000 Rh D negative donors and 500 rare blood donors to meet clinical demands for rare bloods.
Research Activities
In 2012, we have conducted the following studies.
1. Quality of washed platelets after storage
2. Inventory management for Red Cells
3. Analysis of low-Hb donor deferral and subsequent donation of these donors
4. Analysis of donors’ behavior in frequent donation
5. Change of serum ferritin in apheresis donors with iron supplement
6. Change of serum protein and loss of red cells in frequent apheresis donors
7. Coagulation activity in cryoprecipitate prepared from FP24
8. Study on red cell alloantibodies in blood donors
9. Study on soluble CD40 ligand and their correlation with TRALI
10. Change in plasma Hb and K+ during preparation and storage of blood and blood components
11. Change in function of platelets stored in DEHP-free container
 
Institutional Reviewing Board (IRB)
To protect the study subjects and to strengthen the ethical review of research projects, TBSF established Institutional Reviewing Board (IRB) in 2008. Annually, the study projects carried out within TBSF are submitted to the Board for ethical review. In 2010 and 2012, TBSF’s IRB was inspected by DOH for compliance with current regulation.
 
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