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Practice Transformation for Cytotechnologists: The Mayo Clinic Experience. Amy C. Clayton M.D. Mayo Clinic Rochester, MN Conflict of Interest I have no relevant conflicts of interest in regards to the content of the presentation. 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? TRANSFORMATION = CHANGE 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 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? 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) 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 It’s still about the cells! 2010 Results – CT Responsibilities 2000 GYN Non-GYN EUS FNA FISH Analysis FNA Screening ER/PR and Her2 review On site adequacy Digital Image Analysis Ploidy and Proliferation Specimen problem solving Circulating Tumor Cells HE Tumor Identification Manual interpretation Digital image analysis Microdissection for Molecular testing AFB Screens Test Development New Responsibilities: FISH Testing 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 neoplasia2011 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 New Responsibilities: Circulating Tumor Cell Analysis- 2008 Cell Search System New Responsibilities: Automated IHC quantitation 2009 Immunohistochemical Quantitation – HER 2 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 Tumor Microdissection 2011 Tissue Review Volumes 480 460 440 420 Series1 400 380 360 Jan Feb March April May June New Responsibilities 2009 Acid Fast Bacillus stainprescreening for pathologists AFB Case Volume 300 250 246 236 215 200 197 158 150 165 157 160 152 218 211 223 221 212 186 163 155 162 151 143 133 197 196 190 133 100 50 0 Jun09 Jul09 Aug09 Sep09 Oct09 Nov09 Dec09 Jan10 Feb10 Mar10 Apr10 May10 Jun10 Jul10 Aug10 Sep10 Oct10 Nov10 Dec10 Jan11 For 2011: approximately 200 cases per month Feb11 Mar11 Apr11 May11 Jun11 Test Volumes - New Cytotechnologist Roles Additional Roles of Cytotechnologists 35000 30000 25000 Test Volumes 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 DIA Test Implemented EUS FNAs Implemented 0 1995 1996 1997 1998 1999 2000 2001 2002 Year 2003 2004 2005 2006 2007 2008 2009 Career Ladder Cytotechnologist Senior Cytotechnologist Lead Specialist Education/Training Focus Pathologist Assisting Focus Development Technologist Assistant Supervisor Supervisor Quality Focus 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 Requirements Specialist Education/Training Focus Pathologist assisting focus Prescreens FNA specimens; problem solves Quality focus Trains new CT’s; provides education to CT’s, pathologists and residents Tracks quality metrics; prepares lab for inspections 3 years experience Required to pass SCT(ASCP) or MB(ASCP) exam 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 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” Mayo Cytology Development Team 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 Results- Positions 20 Number of Positions Cytotechnologist 15 Lead Senior CT 10 Specialist Dev Tech 5 Asst Supv Supv 0 2000 2010 Year 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 Financial Impact: Cytotech Time VS Pathologist Time Labor Cost Per Test Expanding the Role of Cytotechnologists: a Cost Effective Approach A Cost Effective Approach (Root et al): Test Path Analysis Time Reduction Expense Reduction FISH 96% 71% Breast IHC 86% 67% CTC 71% 41% Cytotechnologist Responsibilities FISH Testing Cytotechnologist FISH Workflow Match Paperwork and Slides 43 minutes per case FISH Analysis Capture Images for Permanent File Enter FISH Interpretation into LIS Pathologist Responsibilities FISH Testing Pathologist FISH Workflow Review Signal Patterns 2 minutes per case Review Representative Images Review Patient Clinical Information Verify/Release Report in LIS A Cost Effective Approach: FISH 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. 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 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 A Cost Effective Approach: IHC- ER, PR, HER 2 Analysis CT time With CT analysis Without CT analysis (min) 18 Pathologis N t Time per year (min) Savings Salary Cost* 3 6000 $91,500 20 6000 $274,980 -$183,480 *Average CT and Pathologist Salaries taken from most recent ASCP survey and Physician Salary Survey: Modern Healthcare;2009, Vol 39, 20-26. Circulating Tumor Cell Analysis CT time Pathologist Time (min) (min) N per year Salary Cost* With CT analysis 31 4 700 $16,507 Without CT analysis 17 14 700 $27,992 Savings -$11,485 * 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 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 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! 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 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. 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” Where does Mayo Fit in the Scheme Described by the Summit? 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! Acknowledgements: (Team Effort!) Lab Supervisors: Lisa Colborn Cytology 1998 -2005 Lab Directors: Tom Sebo: DIA 1994-2002 Gary Keeney: Cytology 1995 -2002 Renee Root: Molecular cytol 2005-present Angela Sorenson: Cytology 2005-present Amy Clayton: Test Development Ben Kipp Jesse Voss Emily Barr Fritcher Shannon Brankley Trynda Oberg Cytology 2002-2007 Cytology School Michael Campion Molecular Cyt 2005-2009 Jill Caudill Doug Minot Michael Henry: Cytology 2007-present Kevin Halling: Molecular Cyt 2009-present Program director 1992- present Amy Wendel AP education supervisor 2006-2009 Kara Hansing: AP education 2010present