B-198 Web-based Application of an Automated Quality Assurance Monitoring System for a Pain Management Panel by Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS)

Abstract

Abstract Background With its advantages in analytical sensitivity and specificity, quantitative drug analysis by LC-MS/MS platform allows the clinical laboratories to provide results that would meet various clinical needs, especially for those to assess patient compliance on pain medications. However, the complexity of the technology and data it generated, poses challenges and burdens to the quality assurance process. In our toxicology laboratory at the University of Kentucky, we offer a pain management panel to physicians for monitoring patients compliance purpose. This is a LC-MS/MS based assay that can simultaneously qualitative up to 52 drugs and their metabolites. Quality monitor of data from this multicomponent drug assays is laborious and inefficient. Our objective here is to develop and implement an effective automated quality assurance mechanism, and eventually improve the laboratory efficiency, reduce lab errors and enhance quality of patient care. Methods Using the Sciex Multiquant software, the daily processed txt file is generated and uploaded to shared drive to be analyzed using a Java based program. The processing of a file is split into three subparts: (1) saving original data, (2) calculating/ verifying the quality assurance metrics with the predefined limits, and (3) producing a report. The original data uses to the database to retrieve specific information without having to reload the file multiple times. When completed, all the data included in the initial report are read along with limit variables. The metrics for quality assurance with predefined criteria includes: System suitability test sample (Retention time, Peak area), Internal standard (IS) peak area, Blank sample peak area, Calibrator accuracy and calibration curve accuracy, Quality control, Ion ratio, Relative retention time to IS. Once these calculations are finished, a report is generated in a format that allows it to be easily read on the website. Results We are able to generated a daily QA report that is web-based application. Discrepancies within any of the statistics are color coded and given a button allows a user to “check” the measurement and provide a reason why this measurement was out-of-scope. All users are allowed to provide reasoning for an out-of-scope measurement and each of these users’ comments is tracked to provide an audit trail. Once all measurements have been reviewed, a report is ready form review. The process can only be completed by a privileged user. Once the process has been completed, the report cannot be modified. With this application, we are not only able to monitor the quality of the run on the day-to-day basis, the QC and instrument behavior can also be evaluated and reviewed longitudinally. Conclusion An effective and efficient web-based quality assurance monitoring system was successfully developed and implemented for this multicomponent drug analysis by LC/MS-MS. The application of this program will facilitate the mass spec platform use in clinical laboratories.