Molecular Diagnostic Lab Pre-analytic Improvements (Phase II ...

Molecular Diagnostic Lab Pre-analytic Improvements (Phase II ...

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. Results of molecular tests determine course of therapy Based on patients likelihood to respond

to certain targeted treatments 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% Molecular Test Activity Activity 180000 160000 140000 120000 100000 80000 60000 40000 20000

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F F F F F 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 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 Strategic Alignment

MD Andersons 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 patients 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. 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 Metrics Turnaround time: Start: When request is created in clinic End: When MDL lab starts analytic processes

Baseline Average TAT: 95th Percentile TAT: Volume: Data entries per request: 7.1 Days 19 Days 517 requests/ month 10.6 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 forbefore each test All occurring the MDL lab gets the specimen

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 off-site storage pathologist office contributing hospital whether sufficient materials are available whether selected materials are appropriate Target

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

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 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 Implementation The implementation plan included: Teams 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 New Process

Removed Request Processing duties & hand-off from MDL Reduced data entry needed for tracking Improved clinicians visibility to request status in EMR 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 Results 21% Improvement Results 31% Improvement

Results 56% Fewer Data Entries Pre-Analytic Tracking Timeframe Benefits Issues Prior to Sep 2008 N/A

No electronic tracking until analytic phase Sep 2008 Electronic Database Not Integrated with LIS Not Integrated with EMR Apr 2009 Integrated with LIS Integrated with EMR

Redundant data entry All tracking at test level Mar 2010 Improved lab integration Feb 2011 Current Simpler EMR Visibility N/A! Less data entry Improved lab integration 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 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) 19% increase in IHC requests 70000 60000 50000 40000 30000 20000 10000 0 FY06 FY07

FY08 FY09 FY10 105% increase in FISH orders 10000 9000 8000 7000 6000 5000 4000 3000 2000

1000 0 FY07-08 FY08-09 FY09-10 Sustainability Systematic changes made to process ensure sustainability TAT monitored on each request via real-time dashboard 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 # Thank You! Contact us: Dr. Lavinia Middleton, MD Ron A. Phipps, MBA [email protected] [email protected]

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