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Reflex EGFR/ALK Testing in
Lung Cancer Patients
Clark McDonald, Pathology
Mathew Kang, Radiation Oncology
LiChung Ku, Radiation Oncology
Tiffany Taylor, Radiation Oncology
Sarah Dawson, Laboratory
Laura Duddy, Clinical Decision Support
Special thanks to: Sean Stack (Radiology), Kamran Firoozi
(Pulmonology) and Adam Miller (IT)
AIM STATEMENT
• 100% of lung adenocarcinoma patients with known or
clinically suspected stage IIIb and stage IV will have
reflex EGFR/ALK testing sent at the time of pathologic
diagnosis by January 15, 2015
Introduction
• Patients with stage IIIb or IV lung adenocarcinomas are
eligible for novel treatment with EGFR tyrosine kinase
inhibitors but only if the EGFR/ALK molecular status of
the tumor is known
• New National Comprehensive Cancer Network Clinical
Practice Guidelines recommend EGFR/ALK testing on all
stage IIIb and IV lung adenocarcinomas
• Old practice was to wait for Oncologist to call and
order EGFR/ALK testing which created delay of
treatment planning up to 2-3 weeks after diagnosis
Results
• Average number of days from biopsy sign out to sent
out for EGFR/ALK testing
Baseline Data
Old Process
Old Process
Radiologist Pulmonologist
Transbronchial biopsy
or lymph note
EBUS-FNA
Lung or Solid Organ
biopsied
Pathology requisition filled
out by Pulmonologist or
Pathologist without
staging information
Send Sample
to Pathology
Pathology does diagnostic
review & creates report
Report goes to Oncologist, Oncologist sees patient and
reviews staging information. If indicated, EGFR is
requested by Med/Onc and sent out by Pathology to
OHSU
Time of Biopsy
Pathology requisition is
completed in Epic without
staging information
Radiologist reviews
any available imaging
Process Delay
Benefits of Change
• Having the EGFR/ALK status at the time of initial
consultation with the treating Oncologist allows a
treatment plan to be developed and initiated rather
than having to order the EGFR/ALK testing and waiting
for the results (7-10 days for testing)
• Reduces time to treatment
• Reduce patient anxiety while waiting for treatment
plan
• Compliance with the national treatment guideline
Test of Change #1
• Pathologists to reflexively send biopsy material for
EGFR/ALK testing on cases with known stage IV lung
adenocarcinoma- eg. Metastasis or positive pleural
effusion- we know these are stage IV
Now what about the rest?
• The pathologists need to know the clinical staging at
the time of tissue diagnosis to reflexively order
EGFR/ALK testing on the lung biopsies
• Old standard work did not encourage clinical staging to
be provided on the pathology requisitions
• Without this staging, appropriate reflex EGFR/ALK
could not be accomplished
PROBLEM
• Lung biopsies are performed by radiologists and
pulmonologists
• Some cases (EBUS-FNA) have pathologists filling out the
pathology requisitions
Test of Change #2 Dr. Firoozi
• Dr. Kamron Firoozi agreed to begin staging his
suspected lung cancer patients at the time of biopsy
and provide the information on the pathology
requisition
• 2/2 bronchoscopic lung biopsy cases were staged at the
time of biopsy and documented on the pathology
requisitions
Test of Change #3 Radiology
• Dr. Sean Stack agreed to communicate with all of the
interventional radiologists that perform image guided
lung biopsies to provide clinical staging of suspected
lung cancer and include on the pathology requisition
• Staging tool was developed and posted at the work
station as reminder for staging
Test of Change #4 Rest of Pulmonologists
• Dr. Firoozi agreed to communicate with the remaining
pulmonologists to provide clinical staging of all
suspected lung cancers on the pathology requisition at
the time of biopsy
Test of Change #5 Pathologists-EBUS
• Communicate with the pathologists that attend
Endobronchial Ultrasound Guided Fine Needle
Aspiration Biopsies to query the pulmonologist about
the clinical staging in suspected lung cancer cases at
the time of the procedure and document on the
pathology requisition
New Process
Radiologist Pulmonologist
Radiologist reviews any available
imaging for clinical staging for
suspected lung cancers
Clinical evaluation of
stage
Lung or solid
organ biopsied
Transbronchial biopsy
or lymph node EBUS-
FNA
If diagnosis is adenocarcinoma and the
requisition clinical stage is 3b or 4, reflex EGFR/
ALK testing is sent same day to OHSU
Time of Biopsy
Pathology requisition is
completed in Epic with staging
information
Sample sent to
Pathology
Pathology does diagnositc
review and creates report
Pathology requisition is completed by
the Pulmonologist or Pathologist with
clinical staging
New Process
Balance Measures
• Avoid REFLEX testing on all lung adenocarcinomas
regardless of stage
Lessons Learned
• Multiple locations and specialties are relied upon to
provide appropriate staging made project challenging
• Education is not always the best way to initiate change
• Compliance diminished over time and needed
strengthening
• Visual tool at the point of order was effective
• Epic best practice alert would capture more staging
information
• Current Epic transition will delay Epic best practice tool
Next steps
• Build Epic best practice tool limited to practitioner and
lung biopsy specific procedure
• Epic order build approved January 14, 2015, cannot
begin work until March 10th
, 2015 after go live date for
Epic 2014
• Development and placement of staging visual aid tool
pathologists and pulmonologists for bronchoscopy suites
• EGFR/ALK testing will be broadened to include stage 3A
lung adenocarcinomas based on new clinical trial Salem
Hospital is participating in

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PLI Project

  • 1. Reflex EGFR/ALK Testing in Lung Cancer Patients Clark McDonald, Pathology Mathew Kang, Radiation Oncology LiChung Ku, Radiation Oncology Tiffany Taylor, Radiation Oncology Sarah Dawson, Laboratory Laura Duddy, Clinical Decision Support Special thanks to: Sean Stack (Radiology), Kamran Firoozi (Pulmonology) and Adam Miller (IT)
  • 2. AIM STATEMENT • 100% of lung adenocarcinoma patients with known or clinically suspected stage IIIb and stage IV will have reflex EGFR/ALK testing sent at the time of pathologic diagnosis by January 15, 2015
  • 3. Introduction • Patients with stage IIIb or IV lung adenocarcinomas are eligible for novel treatment with EGFR tyrosine kinase inhibitors but only if the EGFR/ALK molecular status of the tumor is known • New National Comprehensive Cancer Network Clinical Practice Guidelines recommend EGFR/ALK testing on all stage IIIb and IV lung adenocarcinomas • Old practice was to wait for Oncologist to call and order EGFR/ALK testing which created delay of treatment planning up to 2-3 weeks after diagnosis
  • 4. Results • Average number of days from biopsy sign out to sent out for EGFR/ALK testing
  • 6. Old Process Old Process Radiologist Pulmonologist Transbronchial biopsy or lymph note EBUS-FNA Lung or Solid Organ biopsied Pathology requisition filled out by Pulmonologist or Pathologist without staging information Send Sample to Pathology Pathology does diagnostic review & creates report Report goes to Oncologist, Oncologist sees patient and reviews staging information. If indicated, EGFR is requested by Med/Onc and sent out by Pathology to OHSU Time of Biopsy Pathology requisition is completed in Epic without staging information Radiologist reviews any available imaging Process Delay
  • 7. Benefits of Change • Having the EGFR/ALK status at the time of initial consultation with the treating Oncologist allows a treatment plan to be developed and initiated rather than having to order the EGFR/ALK testing and waiting for the results (7-10 days for testing) • Reduces time to treatment • Reduce patient anxiety while waiting for treatment plan • Compliance with the national treatment guideline
  • 8. Test of Change #1 • Pathologists to reflexively send biopsy material for EGFR/ALK testing on cases with known stage IV lung adenocarcinoma- eg. Metastasis or positive pleural effusion- we know these are stage IV
  • 9. Now what about the rest? • The pathologists need to know the clinical staging at the time of tissue diagnosis to reflexively order EGFR/ALK testing on the lung biopsies • Old standard work did not encourage clinical staging to be provided on the pathology requisitions • Without this staging, appropriate reflex EGFR/ALK could not be accomplished PROBLEM • Lung biopsies are performed by radiologists and pulmonologists • Some cases (EBUS-FNA) have pathologists filling out the pathology requisitions
  • 10. Test of Change #2 Dr. Firoozi • Dr. Kamron Firoozi agreed to begin staging his suspected lung cancer patients at the time of biopsy and provide the information on the pathology requisition • 2/2 bronchoscopic lung biopsy cases were staged at the time of biopsy and documented on the pathology requisitions
  • 11. Test of Change #3 Radiology • Dr. Sean Stack agreed to communicate with all of the interventional radiologists that perform image guided lung biopsies to provide clinical staging of suspected lung cancer and include on the pathology requisition • Staging tool was developed and posted at the work station as reminder for staging
  • 12. Test of Change #4 Rest of Pulmonologists • Dr. Firoozi agreed to communicate with the remaining pulmonologists to provide clinical staging of all suspected lung cancers on the pathology requisition at the time of biopsy
  • 13. Test of Change #5 Pathologists-EBUS • Communicate with the pathologists that attend Endobronchial Ultrasound Guided Fine Needle Aspiration Biopsies to query the pulmonologist about the clinical staging in suspected lung cancer cases at the time of the procedure and document on the pathology requisition
  • 14. New Process Radiologist Pulmonologist Radiologist reviews any available imaging for clinical staging for suspected lung cancers Clinical evaluation of stage Lung or solid organ biopsied Transbronchial biopsy or lymph node EBUS- FNA If diagnosis is adenocarcinoma and the requisition clinical stage is 3b or 4, reflex EGFR/ ALK testing is sent same day to OHSU Time of Biopsy Pathology requisition is completed in Epic with staging information Sample sent to Pathology Pathology does diagnositc review and creates report Pathology requisition is completed by the Pulmonologist or Pathologist with clinical staging New Process
  • 15. Balance Measures • Avoid REFLEX testing on all lung adenocarcinomas regardless of stage
  • 16. Lessons Learned • Multiple locations and specialties are relied upon to provide appropriate staging made project challenging • Education is not always the best way to initiate change • Compliance diminished over time and needed strengthening • Visual tool at the point of order was effective • Epic best practice alert would capture more staging information • Current Epic transition will delay Epic best practice tool
  • 17. Next steps • Build Epic best practice tool limited to practitioner and lung biopsy specific procedure • Epic order build approved January 14, 2015, cannot begin work until March 10th , 2015 after go live date for Epic 2014 • Development and placement of staging visual aid tool pathologists and pulmonologists for bronchoscopy suites • EGFR/ALK testing will be broadened to include stage 3A lung adenocarcinomas based on new clinical trial Salem Hospital is participating in

Editor's Notes

  1. Clark
  2. Clark
  3. Clark
  4. Laura 5 completed tests of change - >33% reduction in average time Variance reduction Outlier elimination
  5. Laura One outlier – above 20 days
  6. Matt
  7. Matt
  8. Clark
  9. Clark
  10. Li
  11. Li
  12. Li
  13. Matt
  14. Matt
  15. Sarah
  16. Sarah
  17. Tiffany