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

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

• Dr. Lavinia P. Middleton, MD
• Ron A. Phipps, MBA

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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

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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

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Molecular Test Activity
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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
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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
• PLM Divisional Quality Improvement
• Ron Phipps, Martha Johnson-Hamilton, Han Le,
  Charisse Acosta, Joan T. Woods

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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.

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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
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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
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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
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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

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Target Areas

• Request Received by MDL
• MDL checks for existing
• DNA / slides
• MDL Logs requested tests
• MDL Lab forwards request
• to Expeditors

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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

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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

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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

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New Process

• Removed Request Processing duties hand-off
  from MDL
• Reduced data entry needed for tracking
• Improved clinicians visibility to request
  status in EMR

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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

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Results
21 Improvement
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Results
31 Improvement
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Results
56 Fewer Data Entries
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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 Redundant data entry All tracking at test level
Feb 2011 - Current Simpler EMR Visibility Less data entry Improved lab integration N/A!
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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
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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)

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19 increase in IHC requests
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105 increase in FISH orders
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Sustainability

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

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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

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Thank You!
Contact us Dr. Lavinia Middleton, MD
lpmiddleton_at_mdanderson.org Ron A. Phipps,
MBA raphipps_at_mdanderson.org