Quality Objectives

1. Conducting the specimen processing per protocol requirement and protocol specific SOPs, such as dry blood spot, serum, plasma, PBMC (dry pellet, cell lysate for intracellular PK or viable cell for immunology assay) based on standard quality.

The specimen processing, especially viable PBMC, the cell viability and cell yields must be in the acceptable range. Only staff who passed the Proficiency testing for PBMC cryopreservation from Immunology Quality Assessment Center: IQA (Duke Human Vaccine Institute) can operate the viable PBMC processing. The every 3 months proficiency testing has been done for certification updated. However, the Internal PBMC cryopreservation training and proficiency test for the other staff in the unit can be conducted by the certified staff.

2. Conducting the specimen storage in proper conditions in certified equipment such as 20°c, 4°c refrigerators, -40°c, -80°c freezers and -196°c liquid nitrogen with 24 hours-controlled temperature.

3. Conducting the specimen shipping in several conditions such as ambient, frozen in dry ice and frozen in dry shipper container to both domestic laboratories and international laboratories with 0% of specimens’ deviation and less than 5% of document deviation. The staff who can conduct the international air transport shipment must be trained and pass the exam of IATA regulations and retraining every two years. More than 20 years’ experience in international shipping.

4. Improve the productivity by using the Continuous Quality Improvement.

5. The staffs have been retrained to keep the quality and standard of work.

6. Create awareness in team work.