TRICORE USES A CLOUD-BASED PLATFORM TO SPEED UP AND STREAMLINE CHEMISTRY & IMMUNOCHEMISTRY INTEGRATION TESTING
TriCore Reference Laboratories
The Challenge
• Validate a new chemistry automation line and implement a new Lab location with high pressure deadlines
Objectives
• Coordinate implementation and validation of Roche Infinity across multiple sites with a 4-week timeline
• Expand The Southern Clinical Lab in Las Cruces from SARS CoV-2 only to a full menu of chemistry, immunochemistry, hematology, urinalysis and coagulation
Solution
• Cymetryc
The Challenge
TriCore faced two projects with high pressure timelines: 1. a chemistry and immunochemistry migration requirement to implement the Roche cobas c503 analytical unit for clinical chemistry and Roche e801 immunochemistry module. The project included end-to-end integration testing and data validation as well as preparing compliance documentation; and 2. The Southern Clinical Lab in Las Cruces planned a test menu expansion from SARS CoV-2 only testing to a full menu of chemistry, immunochemistry, hematology, urinalysis and coagulation tests. As with similar projects, the laboratory needed to prove prior to go-live that the analytical specifications were built correctly, that other connected systems would not be negatively impacted by the change and that fidelity and quality of testing is preserved. Irrespective of the accelerated timelines, high quality would be a paramount objective.
Integration testing processes at TriCore are manual and require the use of multiple programs (spreadsheets, word processing, email), in-person collaboration, and tedious cut and paste techniques to build a large volume of paper documentation reports. And completely absent from their current process: visibility to status, progress of testing, and no centralized collaboration capability. “Although we have always done it this way, it became clear that we could not effectively impact our projects unless we made a change to our data validation process,” explains Dr. Veronica Luzzi, Section Chief and Medical Director at TriCore Reference Laboratories and TriCore Research Institute.
Strategy
To manage these projects against short timelines TriCore needed to create a validation plan that would identify the scope of the dry and wet testing for key parameters. “We knew also that our Achilles heel would be validation testing because this can consume one third of an entire project. It would be important to identify a testing methodology that would streamline the process without compromising the intent of our validation plan,” explains Dr. Luzzi. “Altogether we would require about 500 test scripts to exercise the Roche cobas system and about 350 test scripts for the Southern Clinical Lab project, we could not cut corners to meet ambitious timelines.”
Outcomes
TriCore decided to select cloud based Cymetryc™, from Software Testing Solutions (STS). Dr. Luzzi explains, “With help from STS our test scripts were uploaded to Cymetryc for each of our testing events. Once test scripts were available on the Cymetryc platform our process was significantly streamlined which enabled the testing timelines to be achieved. Onboarding Cymetryc was not difficult, even for a range of skill sets. We could begin using it quickly. Most importantly, we were no longer constrained by our legacy processes. Visibility to testing and approving tasks enabled us to prioritize our work, collaborate quickly and help one another in the moment. Mountains of paper were eliminated. Most surprising to us, is that now that we were using a solution that is fit for purpose, we could devote our attention and time on actual testing and review.
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“Without the distraction of tedious manual tasks and cumbersome documentation processes, it was easier for us to spot errors and we gained unprecedented efficiencies of testing which had a direct impact on meeting our timeline goals.”
– Dr. Veronica Luzzi, Section Chief and Medical Director
TriCore Reference Laboratories and TriCore Research Institute
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Learnings
“It helped to keep a master test code / reference range list to refer to when medical directors are reviewing outcomes in Cymetryc,” said Dr. Luzzi. “We also learned that our testers must be more diligent in annotating outliers or specific acronyms that were not previously shared. At the time of these projects, we would have benefitted from a mechanism to track a rejected test case or issue. STS has since released an integrated issues management module inside Cymetryc. We look forward to using it with our next project.”
What is Next at TriCore
TriCore has decided that all future integration testing and re-testing will be accomplished using Cymetryc. “There is no need or desire to go backwards,” says Dr. Luzzi. “Cymetryc represents the future for integration and software validation testing. Soon we will be implementing a new LIMS at TriCore Research Institute. Cymetryc will be a part of that project as well.”
__________________________
“Onboarding Cymetryc was not difficult, even for a range of skill sets. We could begin using it quickly.”
– Dr. Veronica Luzzi, Section Chief and Medical Director
TriCore Reference Laboratories and TriCore Research Institute