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Molecular Diagnostic Lab Pre-analytic Improvements (Phase II Project)

Molecular Diagnostic Lab Pre-analytic Improvements (Phase II Project). Dr. Lavinia P. Middleton, MD Ron A. Phipps, MBA. Background. In the treatment of cancer: Personalized medicine is the use of genetic markers and/or pharmacogenomic testing to tailor an individual's therapy.

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Molecular Diagnostic Lab Pre-analytic Improvements (Phase II Project)

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  1. Molecular Diagnostic Lab Pre-analytic Improvements (Phase II Project) Dr. Lavinia P. Middleton, MD Ron A. Phipps, MBA

  2. Background In the treatment of cancer: Personalized medicine is the use of genetic markers and/or pharmacogenomic testing to tailor an individual's therapy. Results of molecular tests determine course of therapy Based on patient’s likelihood to respond to certain targeted treatments

  3. Many Sustained Improvements Changes Implemented in Previous Project: Restructured LIS with Molecular test-level case type Developed electronic Request Form Increased Space & Organization for Expeditors Workflow changes for Pathologists & Expeditors Developed Electronic Whiteboard of pending cases Results: Reduced pre-analytic TAT by 45% from 2008 to 2010 During this timeframe, growth was 88%

  4. Molecular Test Activity

  5. AIM Statement The purpose of this project was to further reduce the turnaround time for the pre-analytic phase of Molecular Diagnostic Lab (MDL) tests from a baseline of 7.1 days by 25% by the end of 2011. Focus: Further improving efficiencies & eliminating waste to increase capacity

  6. Team Pathology Faculty: Dr. Lavinia Middleton, Dr. Asif Rashid, Dr. Stanley R. Hamilton Pathology Administration / Lab Management: Pam Puig, Kaye Barr, Donna Skidmore, Sherrie L Jackson, Javier Guerrero Hematopathology Faculty: Dr. Raja Luthra, Dr. Zhuang Zuo Hematopathology Administration / Lab Management: Ann C Reynolds, Cindy Lewing, Christopher Bowman Laboratory Informatics: Dr. Mark Routbort, Lori Heydon, Judson Dunn, Huimin (Lily) Lu, Trey Elliott P&LM Divisional Quality Improvement: Ron Phipps, Martha Johnson-Hamilton, Han Le, Charisse Acosta, Joan T. Woods

  7. Strategic Alignment MD Anderson’s Strategic Goals: Patient Care: Strategy 1.2 - We will increase the quality, safety and value of our clinical care.  Strategy 1.5 - We will enhance productivity, access and efficiency by strengthening our infrastructure and support systems.  Research: Strategy 2.2 - We will lead in the personalization of cancer diagnosis and treatment by detecting and targeting specific genetic and molecular abnormalities in a patient’s cancer and the tissue microenvironment, enhancing immune responses, and improving targeted radiation and surgical treatments. Resources: Strategy 7.1 - We will continuously improve our administrative infrastructure to support the efforts of our people in achieving our mission through health information technology and quality improvement education and research.

  8. Strategic Alignment The new Institute of Personalized Cancer Treatment (IPCT) Expectation: Better outcomes can be achieved Therefore, quick turnaround time is imperative to initiate cancer care

  9. Metrics Turnaround time: Start: When request is created in clinic End: When MDL lab starts analytic processes • Baseline • Average TAT: 7.1 Days • 95th Percentile TAT: 19 Days • Volume: 517 requests/ month • Data entries per request: 10.6

  10. Baseline Process • Issues: • Lots of Scenarios • 11 Decisions • 105 Pathways • 7 to 28 Process Steps • Lots of Hand-offs • Range: 2 to 17 • Lots of Data Entry • Up to 5x for each test All occurring before the MDL lab gets the specimen

  11. Causes of Delays The number of steps in the pre-analytic process varies greatly depending on: the scope of testing needed whether DNA is already available where pathology specimen materials are located: File room pathologist office off-site storage contributing hospital whether sufficient materials are available whether selected materials are appropriate

  12. } } Data Entry on Tracking Steps Target Areas • Request Received by MDL • MDL checks for existing DNA / slides • MDL Logs requested tests • MDL Lab forwards request to Expeditors

  13. Solution Restructure the LIS: Create a separate “Request-level” case type One transaction per patient request Eliminates redundant test-level data entry Used in all pre-analytic tracking steps The test level “M-numbers” would now be used only during the analytical phase

  14. Overcoming Obstacles Concerns: MDL Lab concerned that Expeditors would “get all the gains” Resolution: Modify Proposed Solution: Ensure MDL “M-Case” entry would be less work Increased integration of their systems Pre-populated many fields from the R-Case Take tasks from MDL lab personnel Expeditors now perform initial review One less hand-off! MDL lab would only be involved when materials are ready for testing

  15. Implementation The implementation plan included: Team’s detailed review of process flows Development of the IT application Multiple meetings to review application in test environment Comprehensive testing & validation Go-live planning Role changes / training / communications

  16. New Process • Removed Request Processing duties & hand-off from MDL • Reduced data entry needed for tracking • Improved clinician’s visibility to request status in EMR

  17. Other Changes Interface changes in other systems Linked history of "R-Series" with "M-Series" to ensure complete tracking Job function changes For both the MDL lab & Pathology Expeditors to support the new system Procedures updated for the various areas Transitioning from offline electronic Request Form to EMR Order Entry per Order Sets

  18. Results 21% Improvement

  19. Results 31% Improvement

  20. Results 56% Fewer Data Entries

  21. Pre-Analytic Tracking

  22. ROI / Benefits Soft Savings: $20,290 in personnel time / year Qualified Benefits: Win-Win! Saved time for MDL Lab & Expeditors Increased capacity to meet growing demand Improved tracking management of pending work Increased accountability Enhanced visibility of test request status in EMR Getting patients their results 1.5 days sooner… “Priceless”

  23. Generalizability After the solution was adopted for Molecular tests, the “R-series” case type solution was expanded throughout their pre-analytic phases for: Immunohistochemistry (IHC) Fluorescence in situ hybridization (FISH) Reference Labs (Oncotype DX)

  24. 19% increase in IHC requests

  25. 105% increase in FISH orders

  26. Sustainability Systematic changes made to process ensure sustainability TAT monitored on each request via real-time dashboard

  27. Next Steps Develop a process to prospectively obtain tissue both for diagnosis and molecular studies • Further turnaround time improvement expected in resulting molecular tests Continue to gain efficiencies: • Billing verification tasks done by the lab • Leverage increasing use of Clinic Order Sets • Details Medical Necessity or Protocol #

  28. Thank You! Contact us: Dr. Lavinia Middleton, MD lpmiddleton@mdanderson.org Ron A. Phipps, MBA raphipps@mdanderson.org

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