Pathologist
Extenders:
Current and Future
Amy Clayton, M.D.
Vice Chair Clinical Practice and Quality
Department of Laboratory Medicine and Pathology
Mayo Clinic, Rochester MN
Notice of Faculty Disclosure
In accordance with ACCME guidelines, any individual in a position to influence and/or control the content of this ASCP CME activity has disclosed all relevant financial relationships within the past 12 months with commercial interests that provide products and/or services related to the content of this CME activity.
The individual below has responded that he/she has no relevant financial relationship(s) with commercial interest(s) to disclose:
Amy Clayton
1
Presentation Objectives
• Past and Present Practice Gaps
• What historical solutions have been considered • “Pathology Extender” roles at Mayo Clinic
– Why?
– Our current model (career ladder for cytotechnologists)
– Financially worthwhile?
• Possible Future models
Pathology Practice Landscape
• Declining Reimbursement
• Pathologist shortage predicted
• Consolidation of Pathology practices/services
Need for innovative practice strategies – Cost effective high quality patient care
– Coverage of remote sites
Pathology Extenders seem logical approach
2
Pathologist Extender Concept is Not New
What practice needs have been filled by lesser paid, qualified laboratory professionals?
• Pathology Assistants (AAPA Bylaws):
– Management of (accessioning, clinical history review, grossing, photography, and triage of specimens for light microscopy and additional studies) Surgical and Autopsy pathology specimens, Resident teaching and Administrative responsibilities
• Cytotechnologists:
– Screening Cytology: GYN, Non‐GYN, FNAs – Sign out: Negative GYN PAPs
Current Pathologist Practice Gaps?
• Soaring need for management of ancillary prognostics, companion diagnostics, regulatory requirements for pre‐
analytic, analytic and post‐analytic practice elements
• Digital Pathology
– Image analysis, image selection, remote transmission, archive and annotation
• Rapid On‐Site Evaluation (ROSE) reimbursement
– Endoscopic, Bronchoscopic, radiographic, ultrasonic FNA procedures Many practices are sacrificing 88132 reimbursement because it’s not cost effective to send pathologist to procedure
• Screening assistance on high volume specimens that require intense focus and orientation to detail
– Microorganisms, prostate biopsies, ECC, Cervical cone
• Other?
3
What are Societies Doing?
ASC: “New Profession for Cytotechnologists Task Force” (2006)
Engaged Forbes Group to analyze profession
• Defined cytology profession as “unique body of knowledge” that fills an existing or emerging market gap
• ..there is economic justification...for a more highly skilled cytology profession
• Predicts clinician and pathologist shortage...requires new systems
ASC: New Profession for Cytotechnologists Task Force (2006) Forbes Group: • Health consumerism ...changing laboratory industry....demanding more cost effective testing
• Expanding scope of cytologists ....could prove essential to increasing productivity and efficiency of cytopathology
• Digital image management important‐ do cytopathology labs want to be at table or let radiology do it?
4
Future of Cytology Summit American Society of Cytopathology annual meeting, 2009
• Proposed Strategies:
1. Do Nothing (let the profession evolve)
2. Optimize the current scope of practice
• without additional formal education
• “on the job training”
3. Expand Cytotech role with novel educational tools (Career ladder)
• Master’s degree
• Combine with CLS programs
• Combine with Pathology Assistant programs
4. Create a new Cytotechnologist Professional position: “Cytopathology Assistant”
What are individual practices doing? Share our (Mayo) journey…
2000- 2014
5
Our Own Transformation
Mayo Clinic Practice Needs:
• Pathologist Shortage in our group
• Increasing workload
• ACGME resident requirements limited practice coverage needs • Innovation to improve Cytology Testing
– FISH on cytology specimens (biliary brush, bronchial brush)
– Ploidy analysis
– Need more from less (testing on smaller specimens) • Exploding need for histologic tumor ID and workflow management for molecular genetic testing
• Improved quality desired for quantitative IHC analysis (ER/PR/HER2)
Expanded Pathology Assistant Roles
• Complete autopsies: record review, dissection, PAD, histologic review and FAD (final sign‐out by pathologist).
• Death Scene Investigation (including mass fatality planning, infant mortality review, cremation approval)
• Coding
• Tissue procurement for research
• Gross and Microscopic synoptic template development
• Mock up death certificates (D/C) for pathologists
• Training and competencies for Histotechnologists
• Supervisory role (to include personnel management) in Frozen Section and Routine Gross Laboratories
6
Expanded Cytotechnologist Roles • Unique skills of the cytotechnologist
• Excellent microscopic morphology skills
• Well developed understanding of neoplasia concepts (reactive atypia, hyperplasia, in situ/invasive neoplasia)
• Developed cytotechnology curriculum that supports the expanded cytotechnology roles It’s still about the cells!
7
Mayo Cytotechnologist Responsibilities
2014
2000
– GYN
– Non‐GYN
– EUS FNA
– FISH Analysis
– FNA Screening
– ER/PR and Her2 quantitation
• Manual • Digital image analysis
• On site adequacy
– Digital Image Analysis
• Ploidy and Proliferation –
–
–
–
Circulating Tumor Cells
AFB Screens
Test Development
*Workflow Management Support
• Molecular Testing
• Specimen problem solving
Circulating Tumor
Cell Analysis
8
Immunohistochemical Quantitation – HER 2
Cytotechnologist Review of Tissue Specimens:
Tumor ID for Molecular Testing
2011 Tissue Review Volumes
480
460
440
Series1
420
400
380
360
Jan
Feb
March
April
9
May
June
• Acid Fast Bacillus stain‐ prescreening for pathologists
AFB Case Volume
300
250
246
236
215
200
158
150
165
160
157
152
218
211
197
223
221
212
186
163
155
162
151
143
133
197
196
190
133
100
50
0
Jun09
Jul09
Aug09
Sep09
Oct09
Nov09
Dec09
Jan10
Feb10
Mar10
Apr10
May10
Jun10
Jul10
Aug10
Sep10
Oct10
Nov10
Dec10
Jan11
Feb11
Mar11
Apr11
May11
Jun11
For 2011: approximately 200 cases per month
Multidisciplinary Workflow Facilitators:
Clinician to AP to Molecular Lab
Ancillary Prognostic/Theragnostic testing requests
• Pre‐analytic –
–
–
–
–
Test utilization (is order appropriate?)
Specimen adequacy
Block selection
Post histology tissue review (tumor percent)
Facilitate transfer to molecular lab for testing
• Analytic • Post Analytic – Integrated reports (HER2,ER,PR,MIB) 10
Future expanded
need with
molecular
testing?
Test Volumes - New Cytotechnologist Roles
Additional Roles of Cytotechnologists
35000
30000
25000
T e s t V o lu m e s
Automated HER2
Implemented
FNAs
Tumor Identification
AFB
Circulating Tumor Cells
ER/PR/HER2
FISH
DIA
Tumor Identification and
AFB Screening Implemented
Circulating Tumor Cell Test
Implemented
ER/PR/HER2 CT review
Implemented
20000
15000
FISH Test Implemented
FNA Pre-Screens
Implemented
10000
5000
EUS FNAs
Implemented
DIA Test
Implemented
0
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
Ye ar
Cytotechnologist Career Ladder
Cytotechnologist
Senior Cytotechnologist
Lead
Specialist
Education/Training Focus
Pathologist Assisting Focus
Development Technologist
Assistant Supervisor
Supervisor
11
Quality Focus
Distribution of Cytotechnologists in Expanded Roles
20
Number of Positions
Cytotechnologist
Lead
15
Senior CT
Specialist
10
Dev Tech
Asst Supv
5
Supv
0
2000
2010
Year
Financial Impact:
Cytotech Time VS Pathologist Time
Labor Cost Per Test
12
A Cost Effective Approach Test
Path Analysis
Time
Reduction
Expense
Reduction
FISH
96%
71%
Breast IHC
86%
67%
CTC
71%
41%
Cytotechnologist FISH Workflow
Cytotechnologist Responsibilities
FISH Testing
Match Paperwork and Slides
43
minutes
per case
FISH Analysis
Capture Images for Permanent File
Enter FISH Interpretation into LIS
13
Pathologist Responsibilities
FISH Testing
Pathologist FISH Workflow
Review Signal Patterns
Review Representative Images
2
minutes
per case
Review Patient Clinical Information
Verify/Release Report in LIS
FISH Process Cost Analysis
With CT
analysis
CT time Pathologist
Time
(min)
(min)
43
2
Without CT
analysis
38
Savings
N per
year
Salary
Cost*
6099 $149,904
6099 $531,127
$375,598
*Average CT and Pathologist Salaries taken from most recent ASCP survey and
Physician Salary Survey: Modern Healthcare;2009, Vol 39, 20-26.
14
IHC Workflow
CT Responsibilities:IHC‐
ER,PR, HER 2
Match paperwork with slides
Check paperwork for fixation times
18 minutes
per case
Verify invasive versus in situ cancer
Perform IHC quantification – manual
and image analysis
Enter interpretation into LIS
Enter methodology, fixation,
and controls comments
Pathologist Responsibilities:IHC‐
ER,PR, HER 2
Pathologist Workflow
Review H&E Slides and Verify Tumor
3 minutes
per case
Review IHC Slides – Verify IHC Score
Verify /Release Final Report in LIS
15
IHC‐ ER, PR, HER 2 Analysis
(min)
Pathologist
Time
(min)
18
3
6000 $91,500
20
6000 $274,980
CT time
With CT
analysis
Without
CT
analysis
N:
per
year
Salary Cost*
$183,480
Savings
*Average CT and Pathologist Salaries taken from most recent ASCP survey and
Physician Salary Survey: Modern Healthcare;2009, Vol 39, 20-26.
What Makes Sense for Our Practice? • Use Cytotechnologists in Expanded Roles
– Provide cost effective service
– Reduce burden on Pathologists
– Preserve the field of cytotechnology
in effect preserving the application of morphologic assessment on numerous aspects of laboratory testing
– Enhance satisfaction for cytotechnologists
16
Mayo Pathology Laboratories: What have we done? • Expanded Cytotechnologist Role?
Yes
• Changed Pathologist‐Cytotechnologist Relationship?
– Still work as team
– New group of pathologists to work with:
Surgical Pathologists, Molecular Pathologists
• Created Visibility for Cytotechnologists in Department/Institution? Yes
– Impact on resource allocation?
YES!
Mayo Cytology Laboratories: What have we NOT done?
• We have not worked outside the current regulatory environment
– No change in CPT codes/billing
– Pathologist does final review on all activities
• Cytotechnologist as an Independent Practitioner
– Much bigger than our single practice can change
17
Future of Cytology Summit American Society of Cytopathology annual meeting, 2009
• Proposed Strategies:
– Do Nothing (let the profession evolve)
– Optimize the current scope of practice
• without additional formal education
• “on the job training”
Mayo Model
– Expand Cytotech role with novel educational tools (Career ladder)
• Master’s degree
• Combine with CLS programs
• Combine with Pathology Assistant programs
– Create a new Cytotechnologist Professional position: “Cytopathology Assistant” ?Current
or
Interest
(Advanced Morphology Practitioner)
What Gaps are Still Left to Fill?
• Microscopic review of high volume biopsy/surgical specimens (prostate, GYN, Lymph node dissection)
• Triage/preorder IHC on selected case types
• Clinical Liaison – Test utilization, report queries, specimen submission queries
• Digital Pathology needs
• Integrated Reporting – Molecular/Ancillary Prognostic results
• ROSE (billable by “advanced practitioner”)
• Sign‐out of “Negative” Non‐GYN cytology (billable)
18
Is it time for: “Advanced Morphology Practitioner”?
• Are we doing things in our practice that can be better managed by additional pathologist extender activities ?
Allowing pathologists to focus efforts on more cost effective practice activities
– Pathology assistant role (gross, staging, autopsy, education) is well established, but more opportunities exist
– Advanced morphology practitioner role is evolving
• Cost effective in our practice model • Can that be applied more broadly to encompass independent review? – Predicated on knowing when to escalate to pathologist (no different than NP/PA model)
– What Educational Curriculum would support?
Advanced Morphology
Practitioner
Model A (Mayo Model)
Bill for services as
currently done
Pathologist
Advanced
Morphology
Practitioner
19
Advanced Morphology
Practitioner
Model B (Physician Assistant)
Bill for services as
currently done
Pathologist
Bill
independently
for selected
services
Advanced
Morphology
Practitioner
The Time is Right for Innovative Practice Strategies Requires Bold Leadership
Focus on Value Based Patient Care
Collaborative Spirit 20