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 patient’s 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

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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
 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 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.
 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: 7.1 Days
95th Percentile TAT: 19 Days
Volume: 517 requests/
month
Data entries per request: 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
All to 5x forbefore
occurring each test
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 pathologist office
off-site storage 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:

– 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
 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
 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 • N/A • No electronic tracking until
2008 analytic phase
Sep 2008 • Electronic Database • Not Integrated with LIS
• Not Integrated with EMR
Apr 2009 • Integrated with LIS • Redundant data entry
• Integrated with EMR • All tracking at test level
Mar 2010 • Improved lab integration
Feb 2011 - • Simpler EMR Visibility • N/A!
Current • 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

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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
 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 lpmiddleton@mdanderson.org

Ron A. Phipps, MBA raphipps@mdanderson.org