Molecular Diagnostic Lab Pre-analytic Improvements (Phase

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Transcript Molecular Diagnostic Lab Pre-analytic Improvements (Phase

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:
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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
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 to 5x for each test
All occurring before 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:
– 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
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
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105% increase in FISH orders
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FY07-08
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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
Ron A. Phipps, MBA
[email protected]
[email protected]