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

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What now...

Conflict of Interest I have no relevant conflicts of interest in regards to the content of this presentation. Thank you Amy Clayton, MD Mayo Clinic Rochester, MN

The Duke Experience

2005 2013 Duke s Progression (Areas of Concentration) 2005 Screening 2006 Supervisor Cytopreparatory Area, Resident Training Coordinator, CE Coordinator, QA Coordinator, Safety Officer, CT Student Coordinator (CT s expand areas of responsibility) 2007 Academic involvement 2008 HPV Testing performed by cytology 2009 International Cytology involvement Peru 2010 Pap volume decline begins; Amy Clayton, MD Mayo Experience 2011 Developed CT Career Ladder (based on Mayo Model with help of Dr Clayton) 2012 Developed Career Ladder for Cytoprep Staff 2013 Developed FNA Specialist position

Following slides from Amy Clayton, MD with permission

Mayo Career Ladder Cytotechnologist Senior Cytotechnologist Lead Specialist Education/Training Focus Pathologist Assisting Focus Quality Focus Development Technologist Assistant Supervisor Supervisor

Career Ladder Specifics (to include CT FTE s by category) Supervisor- General Cytology (1) Supervisor- Molecular Cytology (1) Asst Supervisors (2) General Molecular Cytology Cytology Specialists (7) QA GYN QA NonGYN Pathology sign-out room: Cytopathologist Assistant Education: Training for new tests, Continuing Ed Float (back up for sign out and extra projects) Molecular- FISH and DIA

Career Ladder Specifics (cont d) Leads (3) Preparation General Cytology FISH Senior Cytotechnologists (12) Cytology emphasis (Gyn & Non-Gyn screening) Molecular emphasis (Non-Gyn Screening only) Cytotechnologists (12)

Career Ladder Specifics (cont d) Test Development Cytopathology Development Technologist Coordinator (1) Development Technologists (5) Program Director Cytology School (1) Education Specialist (shared with lab) (1)

Position 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

Position 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

Position Requirements (cont d) Assistant Supervisor Assists managing personnel 5 years experience Supervisor Manages lab workflows and personnel 6 years experience Program Director Cytology School

Career Ladder

Cytopreparatory Staff Clinical Laboratory Technician I - entry level - no experience Clinical Laboratory Technician II - 1-2 years laboratory experience Cytoprep Technician/Histotechnician I - 2 years experience in cytopreparation - Completion of ASCT Cytoprep online course

Cytotechnologist Level I Evaluate gynecologic &/or non-gynecologic slides for the presence or absence of disease Provide differential diagnoses & discuss cytologic criteria Accurately record diagnoses in the computer Submit appropriate slides to the pathologist for review Review patient history related to diagnoses Review specimen requisition/slide for completeness & accuracy of labeling Review individual statistics with manager on a monthly basis Participate in semi-annual CLIA diagnostic review with manager & medical director Help in the cytopreparation area as necessary Recognize cytologic (diagnostic /preparatory) issues of concern & address with appropriate CT staff member Regularly participate in CE activities

Cytotechnologist (Senior) - Level II Mentor & instruct cytotechnology students Assist in training new junior cytotechnologists Identify cases for educational resources & share with the Coordinator of Resident Education Participate in one (1) laboratory or hospital committee Participate in interim CAP inspections

Cytotechnologist (Lead) - Level III Perform 10% QC & 5-year look back re-screen (CLIA required >/= 5 years) Plan, develop, present, &/or participate in workshops, scientific papers, & posters Help collect & maintain cases for educational resources under the direction of the Coordinator of Resident Education Participate in resident teaching under the direction of the Coordinator of Resident Education Participate & lead journal club Participate in at least one (1) committee & one (1) rotation Participate as CAP inspector (on-site mock inspections)

Cytotechnologist (Specialist) - Level IV Prescreen FNA s, order/evaluate immunohistochemistry stains IHC stain manual quantitation (preview) for ER/PR/HER2NEU Prepare interesting case presentation once per quarter for peers Provide technical/cytologic instruction to medical students/ residents/fellows Oversee technical/education areas independent problem solving, reporting problems & solutions to manager Supervise technical area (Molecular, FNA, Cytopreparatory) Oversee training of new personnel Oversee the development of new procedures Oversee research projects Attend management/supervisor meetings as needed Participate in various personnel actions including hiring, performance appraisals, promotions, transfers; & vacation & daily work schedules of technical staff. Participate in at least two (2) committees/projects & one (1) rotation Participate as outside CAP inspector

Required Qualifications Education: Bachelor of Science degree in cytotechnology or related field or a Bachelor of Arts degree with 20 semester hours of required science coursework. Successful completion of an accredited cytotechnology program.

Required Qualifications Experience: Level I : 0 3 years Level II: >3 years Level III: >/=5 years Level IV: >/= 10 years

Required Qualifications Degrees, Licensure, &/or Certification: BS/BA CT(ASCP) certification or eligible (or equivalent) Passing the board certification examination is a condition of continued employment. Level IV: SCT(ASCP) &/or MB(ASCT) (or equivalent) &/or advanced degree Supervisory experience in cytopathology desirable

Required Qualifications Knowledge, Skills, & Abilities: Must be able to screen >/= 50 slides/day. Must be able to distinguish colors Good communication skills Good computer skills Good organization skills Level IV: High level & understanding of cytology theory & practice through evidence of continuing education

Required Qualifications Distinguishing Characteristics: Level II, III, and IV: Positive role model & mentor to new, less-experienced staff

FNA Specialist General Description of the Job Class Oversee & participate in specialized and complex technical tasks involved in FNA procurement, sample preparation, screening & evaluation for the detection of cancer and/or other pathologic conditions along with specific specialist responsibilities.

Duties & Responsibilities Participate in interventional FNA procedures to prepare the sample, including triage for ancillary studies Perform the immediate assessment for adequacy. Evaluate permanent FNA slides for the presence or absence of disease Provide differential diagnoses & discuss cytologic criteria Accurately record diagnoses in the computer Submit appropriate slides to the pathologist for review

Duties & Responsibilities (cont d) Review patient history related to diagnoses Provide any pertinent additional clinical information to pathologists Review specimen requisition/slide for completeness & accuracy of labeling Triage FNA immediate assessment specimens to include: flow cytometry, special stains, molecular markers Order/preview immunohistochemistry stains

Duties & Responsibilities (cont d) Review associated histology selecting tumor area on H&E for micro dissection for molecular testing. Provide technical/cytologic instruction to medical students/ residents/fellows Employ independent problem solving, reporting problems & solutions to Medical Director of FNA Service Oversee training of new personnel including pathology residents, medical students and cytotechnologists Oversee the development of new procedures

Duties & Responsibilities (cont d) Oversee research projects Plan, develop, present, &/or participate in workshops, scientific papers, & posters Recognize cytologic (diagnostic /preparatory) issues of concern & address with cytology manager or supervisor of preparatory laboratory. Regularly participate in CE activities Perform other related duties incidental to the work described here. Maintain all aspects of FNA clinics & independent FNA locations Act as Safety Officer for FNA Service locations

Required Qualifications Education: Bachelor of Science degree in cytotechnology or related field or a Bachelor of Arts degree with 20 semester hours of biological science coursework. Successful completion of an accredited cytotechnology program.

Required Qualifications Experience: Minimum of 10 years Degrees, Licensure, &/or Certification: BS/BA CT(ASCP) certification (or equivalent) SCT(ASCP) &/or advanced degree

Required Qualifications Knowledge, Skills, & Abilities: Must be able to screen >/= 50 slides/day. Must be able to distinguish colors Good communication skills Good computer skills Good organization skills High level & understanding of cytology theory & practice through evidence of continuing education

Required Qualifications Distinguishing Characteristics: Positive role model & mentor to new, less-experienced staff Experience in supervisory level management, research capabilities, & project management.

At the end of the day... Modified CT Career Ladder to 3 Levels FNA Specialist position will substitute for Level IV FNA Specialist will dual report to Medical Director (diagnostics/management of FNA areas) & Cytology Manager (regulatory) FNA Specialist on par with Pathology Assistants (salary/exempt status)

Opportunities...

Clinical Cytotechnologist... Practitioner? Specialist? Still about morphology, but with the addition of molecular analysis. Triaging specimens for ancillary testing Digital Image Analysis (DIA) Quantitative immunohistochemistry FISH Tumor Identification for Oncology Testing Circulating Tumor Cells (CTC) Identification of microbiologic agents

Triaging Specimens At time of FNA & during cellular evaluation Flow Cytometry Special Stains IHC Molecular Tests

Digital Image Analysis Determining DNA ploidy Performed on invasive breast & prostate ca CT selects sufficient number & appropriate feulgen stained cells for analysis Instrument analyzes cells producing histogram CT analyzes histogram & renders preliminary tumor ploidy status for pathologist

Quantitative Immunohistochemistry Requires instrumentation Assessment performed on tissue CT selects appropriate areas of slide once in instrument for analysis Render preliminary interpretation for pathologist

FISH Urovysion Diagnosis & monitoring for recurrent bladder cancer by detecting aneuploidy in certain chromosomes. Because of morphologic background, CT s play important role in this technology as they use a scanning technique equivalent to screening to identify abnormal cells. Using CT provides for more rapid & accurate assessment Prepare preliminary report for pathologist

Tumor Identification EGFR, KRAS, BRAF... CT examines tissue slides for areas of tumor, marks the areas, & makes sure enough material is available for genetic testing. Pathologist reviews for final determination before testing takes place.

Circulating Tumor Cells Used for metastatic colorectal, breast, & prostate cancers. Cells presented in a gallery format CT identifies, marks, & counts cells that fit definition according to manufacturer guidelines Pathologist reviews cell gallery & CT s findings

Identification of Microbiologics Special stains are performed on tissue specimens specific to agents needing identification, such as acid fast bacilli CT examines the tissue section for the microbiologic agent, identifies it, marks it, & issues a preliminary report (positive or negative; present or absent) for the pathologist.

It s still about the cells!