The Bar-coding System at the UCSD Clinical Pharmacology and Assay Laboratory
Our lab is equipped with a bar-coding system that enables us to quickly and easily track patient samples and all available patient information on any specimen, regardless of the number of specimens in the study or the number of studies. The bar-coding system was specifically designed to meet the needs of our lab and to adhere to Good Laboratory Practices for specimen tracking. The program is password protected, with access allowed only to our staff.
Using a portable bar code scanner, each specimen bar code that the lab assigns is scanned and put in consecutive order into a plastic test tube rack, which also contains a bar code that can be scanned. ("Scanned" means that the bar code label is read by the scanner and information is recorded). When the rack is full, it is scanned into a storage freezer. Anytime a rack or specimen is moved into or out of a freezer, the bar code is scanned and the action is recorded in the bar code program. The bar code program stores the current location of all specimens and the specimen specific movement history (i.e. when the specimen is moved into or out of a freezer and the time it may have been left out). This allows traceability of specimen disposition from the moment the specimen arrives in the lab until it is placed into long-term storage. This satisfies the criteria of paragraph 58.107 of the GLP regulations.
The patient number, the specimen collection date, the quality of the specimen and all other relevant information from the case report form is also stored in the bar code program. After assay, the drug concentrations and assay date are manually entered into the bar code program. All bar code information including results can be transferred electronically as Microsoft Excel spreadsheet files.