Abstract
Effective data collection of donor and islet isolation records is an essential part of any clinical islet transplant program. We have recently developed a customized human islet laboratory information system designed to meet the record keeping, safety standards, and research needs of our human islet laboratory. The system supports data captured in all phases of islet isolation, from the moment the organ is offered to the program to when the last microbiology report is entered into the database. It uses applications that run on desktop computer over standard networks and handheld computer over wireless connection. The system uses Compaq iPAQ™ handheld computers running over wireless network and as an “electronic clipboard,” permitting direct data entry into the database during the islet isolation process. This system has been designed and successfully implemented by the Edmonton Clinical Islet Isolation Laboratory for the classification of information in such areas as materials management (from barcode-based management of media to vendor information) and isolation data capture (including donor and procurement information, microscope image capture of islets during different phases, and determination of yield). The system was intended to meet both Health Canada and Food and Drug Administration (FDA) requirements with respect to user ID and full auditable history of all records, and to be considered equivalent to hard-copy records. Designed as a multi-user system, it supports team collaboration in building a unified, comprehensive digital record of the isolation for comparative purposes. It promotes the capture of isolation data in a consistent, legible, and structured fashion, making it readily usable for comparison, queries, and analysis, as well as making it an excellent tool for training and research in the field of human cell isolation and clinical cell transplantation data records.
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