Practice Transformation for Cytotechnologists: The Mayo Clinic Experience. Amy C. Clayton M.D.

1. Practice Transformation for Cytotechnologists: The Mayo Clinic Experience. Amy C. Clayton M.D. Mayo Clinic Rochester, MN

2. Conflict of Interest I have no relevant conflicts of interest in regards to the content of the presentation.

3. Mayo Cytology:A Decade of Change Share our journey… Why did we change? What new roles are cytotechnologists taking? Cytotechnologist Career Ladder Financial Impact- Does it make sense?

4. 2006: “New Profession for Cytotechnologists Task Force”-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 TRANSFORMATION = CHANGE

5. New Profession for Cytotechnologists Task Force 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?

6. Mayo Clinic Practice Needs: A Decade of Change (2000-2010) Our Own Transformation: Pathologist Shortage in our group Increasing workload Innovation to improve Cytology Testing FISH on urine cytology specimens (UroVysion), biliary brush, bronchial brush Ploidy analysis Expanded need for histologic tumor ID for molecular genetic testing Improved quality desired for quantitative immunohistochemical analysis (ER/PR/HER2)

7. Our Response to Needs Created Roles for Cytotechnologists that make sense for the individual practice (driven by need to save pathologist time and understanding the unique skills of the cytotechnologist) Developed Cytotechnology curriculum that supports the expanded cytotechnology roles

8. It’s still about the cells!

9. Results – CT Responsibilities 2000 GYN Non-GYN EUS FNA On site adequacy Digital Image Analysis Ploidy and Proliferation 2010 FISH Analysis FNA Screening ER/PR and Her2 review Manual interpretation Digital image analysis Specimen problem solving Circulating Tumor Cells HE Tumor Identification Microdissection for Molecular testing AFB Screens Test Development

10. New Responsibilities: FISH Testing

11. New Responsibilities: FISH testing FISH Testing: UroVysion- urine specimens-2000 Cytotechs read in cytogenetics 2000 Molecular Cytology lab- 2005 (processing and reads) Biliary Brush specimens-2004 Bronchial Brush specimens-2006 Esophageal Brush, Barrett’s neoplasia-2011

12. New Responsibilities 2005 FNA Pre-Screen for rapid assessment Slide review for non prescreened FNA cases (QA) before final release 2006 IHC stain- manual quantitation (preview) for ER/PR/HER 2

13. New Responsibilities: Circulating Tumor Cell Analysis- 2008 Cell Search System

14. New Responsibilities: Automated IHC quantitation 2009 Immunohistochemical Quantitation – HER 2

15. New Responsibilities 2009 Histology review- selecting tumor area on HE slides for microdissection for molecular testing • Hereditary Nonpolyposis Colon Cancer (HNPCC)/Lynch Syndrome • ALK in lung cancer • BRAF • KRAS • Multiple sarcoma tests • Many more in future

16. Tumor Microdissection

18. New Responsibilities 2009 Acid Fast Bacillus stain- prescreening for pathologists For 2011: approximately 200 cases per month

19. Test Volumes - New Cytotechnologist Roles

20. Career Ladder

21. Requirements Cytotechnologist Cytology screening; exposure to ancillary testing CT certification Senior Cytotechnologist(Rewards for development of additional expertise and broader testing responsibility) Screening; additional ancillary testing; emphasis based 3 years experience Required to pass SCT(ASCP) or MB(ASCP) exam Lead Troubleshooting; point person for CT’s 3 years experience

22. Requirements Specialist Education/Training Focus Trains new CT’s; provides education to CT’s, pathologists and residents Pathologist assisting focus Prescreens FNA specimens; problem solves Quality focus Tracks quality metrics; prepares lab for inspections 3 years experience Required to pass SCT(ASCP) or MB(ASCP) exam

23. Requirements Development Technologist 1-2 years experience SCT(ASCP) or MB(ASCP) preferred Cytotechnologists and Clinical Lab Technologists Innovation, Research Discovery Clinical Test Validation Work with Vendors, Biotech companies Academic Responsibility Authors Abstracts, Manuscripts

25. From Voss, ASC Bulletin Comparison to other laboratory technologists “Cytotechnologists..unique…ability to combine existing morphologic skills with molecular techniques” “understanding of neoplasia and other diseases”

26. Mayo Cytology Development Team

27. Expansion of CT Roles-2010 Assistant Supervisor Assists managing personnel 5 years experience Supervisor Manages lab workflows and personnel 6 years experience Program Director Cytology School

28. Results- Positions

29. Career Ladder .....Maintaining Proficiency Senior CT with Cytology Emphasis GYN and NonGYN screening Only 2 ancillary rotations allowed Senior CT with Molecular Emphasis Does not do GYN screening Does do NonGYN screening 3 ancillary rotations allowed

30. Financial Impact:Cytotech Time VS Pathologist Time Labor Cost Per Test

31. Expanding the Role of Cytotechnologists: a Cost Effective Approach

32. A Cost Effective Approach (Root et al):

33. Cytotechnologist ResponsibilitiesFISH Testing Cytotechnologist FISH Workflow Match Paperwork and Slides FISH Analysis 43 minutes per case Capture Images for Permanent File Enter FISH Interpretation into LIS

34. Pathologist ResponsibilitiesFISH Testing Pathologist FISH Workflow Review Signal Patterns Review Representative Images 2 minutes per case Review Patient Clinical Information Verify/Release Report in LIS

35. A Cost Effective Approach: FISH *Average CT and Pathologist Salaries taken from most recent ASCP survey and Physician Salary Survey: Modern Healthcare;2009, Vol 39, 20-26.

36. CT Responsibilities:IHC- ER,PR, HER 2 IHC Workflow 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

37. Pathologist Responsibilities:IHC- ER,PR, HER 2 Pathologist Workflow Review H&E Slides and Verify Tumor Review IHC Slides – Verify IHC Score 3 minutes per case Verify /Release Final Report in LIS

38. A Cost Effective Approach: IHC- ER, PR, HER 2 Analysis *Average CT and Pathologist Salaries taken from most recent ASCP survey and Physician Salary Survey: Modern Healthcare;2009, Vol 39, 20-26.

39. Circulating Tumor Cell Analysis * Average CT and Pathologist Salaries taken from most recent ASCP survey and Physician Salary Survey: Modern Healthcare;2009, Vol 39, 20-26.

40. 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

41. Opportunities and Challenges Growth in knowledge and skill sets Adds interest to jobs Assuages concern over decreasing Pap volumes Maintaining competency in multiple areas Scheduling

42. Mayo Cytology Laboratories: What have we done? Expanded Cytotechnologist Role? Yes Changed Pathologist-Cytotechnologist Relationship? Still work as team New group of pathologists to work with Created Visibility for Cytotechnologists in Department/Institution? Yes Impact on resource allocation?YES!

43. 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 Cytotechnologist as an Independent Practitioner Much bigger than our single practice can change

44. Mayo Cytology Laboratories Trying to keep pace with changing times Relieved that our path is in line with society and market analysis conclusions Positive upbeat about future of cytology and the role that cytotechnologists will play Use our practice needs (pathologist shortage, economic press of practice, demand for new improved technologies) to define education curriculum for cytotechnologists.

45. Future of Cytology Summit at ASC meeting, 2009 Developed Strategies: Do Nothing (let the profession evolve) Optimize the current scope of practice without additional formal education “on the job training” Expand Cytotech role with novel educational tools (Career ladder) Master’s degree Combine with CLS programs Combine with Pathology Asst programs Create a new Cytotech Professional position: “Cytopathology Assistant”

46. Our Decade of Change (2000-2010): “Optimize the current scope of practice” without additional formal education “on the job training” Looking Ahead from 2010 “Expand Cytotech role with novel educational tools” We Look Forward to Sharing Our Journey! Where does Mayo Fit in the Scheme Described by the Summit?

47. Acknowledgements:(Team Effort!) Lab Supervisors: Lisa Colborn Cytology 1998 -2005 Renee Root: Molecular cytol 2005-present Angela Sorenson: Cytology 2005-present Test Development Ben Kipp Jesse Voss Emily Barr Fritcher Shannon Brankley Trynda Oberg Michael Campion Doug Minot Lab Directors: Tom Sebo: DIA 1994-2002 Gary Keeney: Cytology 1995 -2002 Amy Clayton: Cytology 2002-2007 Molecular Cyt 2005-2009 Michael Henry: Cytology 2007-present Kevin Halling: Molecular Cyt 2009-present Cytology School Jill Caudill Program director 1992- present Amy Wendel AP education supervisor 2006-2009 Kara Hansing: AP education 2010-present