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

BaselineAverage TAT: 7.1 Days95th Percentile TAT: 19 DaysVolume: 517 requests/ monthData entries per request: 10.6

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

Baseline Process

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 pathologist office

off-site storage contributing hospital

– whether sufficient materials are available – whether selected materials are appropriate

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

to Expeditors

Target Areas

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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

31% Improvement

Results

56% Fewer Data Entries

Results

Pre-Analytic Tracking

Timeframe Benefits IssuesPrior 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• Less data entry• Improved lab integration

• N/A!

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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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