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1. Division of Laboratory Medicine Dept. of Clinical Immunology and Transfusion Medicine Cell Therapy/Stem Cell Laboratory 2.9 Cell Product Administration Infusion of cell product at CTP unit At CT/SC Lab: Data recorded on Administration (2.9.1) Storage status: Administered Clinical Transplantation Program (CTP): - Dept. of Hematology - Dept. of Oncology - Dept. of Pediatric Oncology Final Report on Released Cell Products A written report from CT/SC Lab on distributed and/or cryopreserved products, specifying: Donor and recipient id. ISBT-128 donation id, unit id, product code Laboratory test results Product status: Released/exceptionally released Storage status: Distributed/In store Order and Cell Product Infusion Form Accompanying document at time of fresh cell product distribution from CT/SC Lab, specifying: Ordering physician at CTP and timing of infusion Donor and recipient id. ISBT-128 donation id, unit id, product code Laboratory test results Product release status Documentation of cell product distribution, receipt, administration. Copy returned to CT/SC Lab. 2.2 Donation Donation at external donation center 2.2 Donation The CTP is responsible for the donation procedure, i.e. obtaining donor consent and determining donor eligibility and suitability for the intended recipient. Donor Final Clearance Form Statement from external donation center of donor consent and eligibility To CT/SC Lab prior to product receipt Donor Final Clearance Form Statement from responsible physician at CTP of donor consent and eligibility, including relevant clinical data and lab. test results To CT/SC Lab at time of cell collection Order for Cell Product Receipt and Processing A written order from responsible physician at CTP, specifying product receipt from external collection center, and type and goal of cell processing at the CT/SC Lab. The order is confirmed by CT/SC Lab 2.8 Cell Product Distribution Distribution of fresh cell product for administration to recipient, according to order from responsible physician at CTP. Data recorded on Distribution (2.8.1) Product status: Released/ exceptionally released Storage status: Distributed Order and Cell Product Infusion Form A written order for cryopreserved product from responsible physician at CTP, specifying: Timing of infusion Donor and recipient id. ISBT-128 donation id, unit id, product code Cell dose Accompanying document at time of product distribution from CT/SC Lab., specifying: Product release status Authorization for distribution Documentation of distribution, receipt and administration. Copy returned to CT/SC Lab. 2.4 Cell Product Receipt Receipt of cell product and procurement report from external site Data recorded on Donation (2.2.1), Procurement (2.3.1) and Receipt (2.4.1) ISBT-128 donation id. registered or generated ISBT-128 product code generated Product status: Accepted/rejected, quarantine Order for Cell Collection and Cell Product Processing A written order from the responsible physician at CTP, specifying timing, goal and type of cell collection and cell processing at the CT/SC Lab. The order is confirmed by CT/SC Lab 2.7 Cell Product Release Authorization of cell product release based on pre-determined criteria. Data recorded on Release (2.7.1) Product status: Quarantine/released/ exceptionally released 2.3 Cell Collection Cell Collection from autologous or allogeneic donor at CT/SC Lab. Data recoded on Donation (2.2.1) and Procurement (2.3.1) ISBT-128 donation id. generated ISBT-128 product code generated Product status: Quarantine 2.5 Cell Product Processing Processing of cells according to GMP, e.g. dilution or volume reduction, extraction of ABO-incompatible red cells /plasma, cell enrichment/ depletion, cryopreservation. Laboratory tests for process and product quality control. Data recorded on Processing (2.5.1) ISBT-128 product codes generated Product status: Quarantine 2.6 Cell Product Storage Management of cell product storage Data recorded on Storage (2.6.1) Product status: Quarantine/released/ exceptionally released Storage status: In store/distributed/ administered/returned/recalled/discarded 2.8 Cell Product Distribution Distribution of cryopreserved cell product for administration to recipient, according to written order from responsible physician at CTP. Data recorded on Distribution (2.8.1) Product status: Released/ exceptionally released Storage status: Distributed Key: CT/SC Lab activities CTP activities Printed by