Development of Automated Testing Solution for Sunquest CoPathPlus 6.0 Pathology Informatics 2012 J. Mark Tuthill, MD, Ron Brown Division of Pathology Informatics Department of Pathology and Laboratory Medicine Henry Ford Hospital Detroit, Michigan. Jennifer Lyle Chris Gardenhour Software Testing Solutions Tucson, AZ
What is Validation Testing? Validating that laboratory data displays in a CLIA compliant fashion a receiving system EMR Departmental system Aka Laboratory Results validation testing System functional validation Does my application work as designed? Generating data (cases) to verify a wide variety of functions Calculations, billing, stain orders, quick text, etc J. Mark Tuthill, MD, Henry Ford Hospital
Why Validate? CAP requirement to validate (42 CFR 493.1291): Test ordering in LIS Result reporting in LIS Result display in EMR/external system Required Re-validation every two years (representative sample) On new or modified interfaces (full testing) If report format changes (representative sample Operations Are things built correctly? Has an upgrade broken functionality? Catch coding defects J. Mark Tuthill, MD, Henry Ford Hospital
What do we need to test for AP? Results validation Less complex than CP results as AP is textual and may actual by a direct PDF of the AP report We still need to generate and validate results System Validation Becoming increasingly complex to manually validate all aspects of AP Stains, protocols, billing and quick text Systems are beginning to be interfaced to devices such as auto-stainers that need validation Re-population of data of test area refresh J. Mark Tuthill, MD, Henry Ford Hospital
STS and AP LIS Validation Began to explore with STS how we might develop a testing solution to address AP that would provide benefits as per CP automated testing How do AP LIS and CP testing requirements differ? What is new? What is the most bang for the buck? Where to start? What s next? J. Mark Tuthill, MD, Henry Ford Hospital
STS and AP LIS Validation Functional Requirements Results validation While easier to validate in AP any testing solution would need to generate final reports and screen shots of the activities used to place data in report System Functionality Realization that this is the real value to anap testing solution As many aspects of the AP system should be exercised as possible J. Mark Tuthill, MD, Henry Ford Hospital
System functionality STS and AP LIS Validation Functional Requirements All specimen classes All part types All quick text All stains All protocols All procedures Sign out Secondary events driven by LIS programing E.g. Billing from stains E.g. Quick text associated with part E.g. print labels and engrave cassettes J. Mark Tuthill, MD, Henry Ford Hospital
STS and AP LIS Validation Functional Requirements New Opportunities Cytopathology CLIA report scenario automation Exercise tracking and routing design Test advanced protocols Synoptic reports? J. Mark Tuthill, MD, Henry Ford Hospital
Design Process HFHS Pathology Informatics worked with STS to configure their software solution to automate CoPathPlus testing Began planning October 2011 Active work Winter 2012 First version of product focused on Surgical Pathology workflow June 2012 Next steps: advanced surgical pathology workflow and cytopathology module J. Mark Tuthill, MD, Henry Ford Hospital
What did we accomplish? Screen Shots and Overview of the Solution
STS Applications Similar to clinical laboratory Software Testing Solutions: Environment manager Area where environment is configured Test Manager Where testing is configured, run, and reviewed J. Mark Tuthill, MD, Henry Ford Hospital
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Conclusions Early adopters will need to validate that the surgical pathology volume testing design is flexible enough to work at many different sites Surgical pathology workflow will need to be expanded to address new features and functions Tracking, routing advanced protocols etc Development of surgical pathology scenarios Our first big test of the surgical workflow will be to validate and CoPathPlus interface to Epic J. Mark Tuthill, MD, Henry Ford Hospital
Conclusions Cytopathology Cytopathology modules need development GYN, NONGYN and FNA are all slightly different Workflow and screen design by different sites can vary markedly versus surgical design Development of cytopathology scenarios Can a scenario be developed that will allow automated generation of CLIA reports Cyto-histo correlation? CLIA workload etc J. Mark Tuthill, MD, Henry Ford Hospital
General Conclusions Regarding STS and Automated CoPath Testing Benefits Good return on investment Consistent, thorough testing Reproducibility Comparison between profile runs Reduced analyst stress, better utilization of analyst time and skills Available during non-peak hours Remote access for set up and troubleshooting J. Mark Tuthill, MD, Henry Ford Hospital
General Conclusions Regarding STS and Automated Testing Limitations Costs: capital and annual maintenance costs Staff training, learning curve Profile set up time 1 user/ workstation at a time Remote access is used so that analysts can access software from own desk or off site location Must perform manual comparison of results from LIS to external system display Speed of testing scenarios-can t be accelerated J. Mark Tuthill, MD, Henry Ford Hospital
Development of Automated Testing Solution for Sunquest CoPathPlus 6.0 Pathology Informatics 2012 Questions? J. Mark Tuthill, MD, Ron Brown Division of Pathology Informatics Department of Pathology and Laboratory Medicine Henry Ford Hospital Detroit, Michigan. Jennifer Lyle Chris Gardenhour Software Testing Solutions Tucson, AZ