THE SOUTH AFRICAN MEDICAL RESEARCH COUNCIL
Introduction of a novel monitoring tool to reduce specimen archive errors Lakshmi Jagesur1; Rashika Maharaj1, Avika Haridutt1, Nathlee Abbai1, Duduzile Ndwandwe1 1. HIV Prevention Research Unit, Medical Research Council, 123 Jan Hofmeyr Road, Westville, Durban, 3630, South Africa
Background
Results
• 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. • LDMS is a comprehensive system that allows management of specimens in storage,shipments of specimens and generating data reports for analysis. • 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. • The monitoring tool was implemented in June 2013
• 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.
Figure 1: LDMS Tracking Sheet
Figure 4: Graph showing the number of errors during period Sep 12 to Dec 13
Figure 2: LDMS Shipping Log
Figure 3: Screen shot of specimen management module
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. • Quality error reports were received every month from September 2012 from the statistical center. • The tool was an excel database which was reviewed by the Unit Laboratory Coordinator or Laboratory Manager.
Conclusion • Since the introduction of the award winning novel monitoring tool an improvement to MRC specimen archive quality has been noted. • Due to the monthly review by laboratory management, staff had become aware of the errors made. • In addition, re-training made staff realise that the errors made were trends. • Site laboratory staff and LDMS staff became much more vigilant resulting in a decrease in the error rate. • We recommend that the tool can be adapted by other organizations to improve their long term and high volume specimen archive processes.
THE SOUTH AFRICAN MEDICAL RESEARCH COUNCIL Lakshmi HPRU Poster R2.indd 1
2014/10/22 1:55 PM
Background
Results
• 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. • LDMS is a comprehensive system that allows management of specimens in storage,shipments of specimens and generating data reports for analysis. • 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. • The monitoring tool was implemented in June 2013
• 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.
Figure 1: LDMS Tracking Sheet
Figure 4: Graph showing the number of errors during period Sep 12 to Dec 13
Figure 2: LDMS Shipping Log
Figure 3: Screen shot of specimen management module
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. • Quality error reports were received every month from September 2012 from the statistical center. • The tool was an excel database which was reviewed by the Unit Laboratory Coordinator or Laboratory Manager.
Conclusion • Since the introduction of the award winning novel monitoring tool an improvement to MRC specimen archive quality has been noted. • Due to the monthly review by laboratory management, staff had become aware of the errors made. • In addition, re-training made staff realise that the errors made were trends. • Site laboratory staff and LDMS staff became much more vigilant resulting in a decrease in the error rate. • We recommend that the tool can be adapted by other organizations to improve their long term and high volume specimen archive processes.
THE SOUTH AFRICAN MEDICAL RESEARCH COUNCIL Lakshmi HPRU Poster R2.indd 1
2014/10/22 1:55 PM
