P38.05
Background: The Medical Research Council (MRC), HIV Prevention Research Unit (HPRU) has been involved in the conduct of multiple HIV prevention clinical trials. In order to efficiently track clinical samples from the 6 Clinical Research Sites (CRSs), the laboratory used the Laboratory Data Management System (LDMS) for specimen archive. However, previous specimen verification quality error reports had identified gaps from the collection to archive process within the LDMS system. Therefore, the laboratory developed a novel monitoring tool as part of the quality specimen management programme.
Methods: The monitoring tool was set up for: quality control checks of LDMS documentation against physical specimen verification and monitoring of monthly quality trends. The tool captured the following information: type of errors identified per CRS; participant identifiers (PTIDS); staff responsible for errors, Corrective Actions and Preventative Actions (CAPA) and re-trains performed.
Results: For the period of September 2012-December 2013, out of 369867 samples archived, there were 180 errors: LDMS typographical errors (26/180), incorrect collection dates (19/180), incorrect visit codes (47/180), incorrect Case Report Form (CRF) completion (27/180), incorrect tracking sheet completion (3/180) and CRF and LDMS discrepancies (58/180). The number of errors on average per month ranged from 7 to 15. The new monitoring tool enabled stringent monitoring of specimen management with a significant decrease in errors to a total of 4 errors in December 2013.
Conclusions: Since the introduction of the award winning novel monitoring tool an improvement to MRC specimen archive quality has been noted. We recommend that the tool can be adapted by other organizations to improve their long-term and high volume specimen archive processes.
