2013

TBSF head office and its blood centers are accredited by ISO 9001. In addition, the laboratories of TBSF head office, Taipei Blood Center, and Kaohsiung Blood Center are accredited by the Taiwan Accreditation Foundation (TAF) in the field of medical laboratory. Procedures for donor selection, blood collection, testing, processing, and storage are performed in accordance with procedure manuals. Audit activities including those performed by FDA Taiwan, SGS Taiwan Limited, and CSL Australia, are carried out on a regular basis to ensure the quality of blood and blood components. Moreover, CSL Limited Australia (one of the key plasma fractionator in the world) regularly inspects our centers so as to get approval from TGA Australia (Therapeutic Goods Administration) for manufacturing of Taiwanese plasma.

 

Two out of TBSF’s six blood centers perform blood testing activities. In addition to enzyme immunoassay, nucleic acid testing (NAT) are performed for the detection of HBV, HCV, and HIV-1 on each donation. British working standards are used to monitor and ensure the sensitivity of each test run for viral screening. To minimize manual error, fully automatic instruments such as PK7300, AU2700, Freedom Evolyzer, TIGRIS and Bact/ALERT 3D are used for the detection and interpretation of test results, which are subsequently transmitted to each blood center for the labeling of blood and blood components. To ensure the accuracy of laboratory testing, we take part in the proficiency programs provided by CAP USA, ASHI USA, NRL Australia, and Taiwan Society of Laboratory Medicine on a regular basis. Our testing sesults are therefore considered accurated and reliable through the consistency with those from the majority of the laboratories participated in the programs. Also, we have a medical consultation committee comprised of domestic experts and scholars in transfusion medicine to set forth policies in blood safety.

 

 

As medical science advances, the increase in the number of patients required having long-term transfusion leads to the increase in the demand of compatible bloods, some of these bloods could be relatively rare. As a result, selective donors were subjected to the program for the detection of HLA antigens and red-cell antigens this year as we have normally done. To assist hospital transfusion services in testing of recipient specimens on pre and post blood transfusion, we continue in the provision of diagnostic services which include the detection of red-cell antigens, antibodies as well as HLA antigens. In addition, we continue to play a role in pre-transfusion testing of recipients through the provision of reagent red cells to domestic transfusion services. As required in Southeast Asia to cover the clinically significant antibody, Anti-Mur, for the detection of antibodies for transfusion safety, we, on a regular basis provide donor red cells that contain the required antigens including Mur for domestic demand. Overall, we, as the sole provider of blood and blood components in Taiwan have delivered functional services which are critical to transfusion safety for clinical transfusion practices.

In addition to routine blood center activities, we have actively played parts in research programs with the aim of improving the quality and safety of blood and blood components. The study programs carried out were submitted to TBSF’s Institutional Reviewing Board (IRB, certified by the Ministry of Health and Welfare) as to protect study subjects and to carry out ethical review of the studies as well. During this year, a number of our studies were published at AABB and ISBT annual meetings. Of these, two studies on the subject of platelet antigens and nucleic acid testing were published in international peer-reviewed medical journals.