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

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:

95th Percentile TAT:

7.1 Days

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 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

Prior to Sep

2008

Sep 2008

Apr 2009

Mar 2010

Feb 2011 -

Current

• N/A

Benefits

• Electronic Database

• Integrated with LIS

• Integrated with EMR

• Improved lab integration

• Simpler EMR Visibility

• Less data entry

• Improved lab integration

• N/A!

Issues

• No electronic tracking until analytic phase

• Not Integrated with LIS

• Not Integrated with EMR

• Redundant data entry

• All tracking at test level

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

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