Cytology informatics

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Basic and clinical application of informatics.......for cytology practice

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Dr. S. Rajendiran MD, Dip.R.C.Path, AB (AP&CP), AB (Cyto) Professor of Pathology Sri Ramachandra University, Chennai, India Cytology Informa-t ic s r k K

Game plan:

Game plan Objective Bio/medical informatics Role in cytology Digital imaging Automated screening system QA/QC Comprehensive final report format Take home message References PreTest PostTest

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1. What is Bio/medical informatics? 2. Who is the ultimate beneficiary of informatics? 3. What informatics tools are available? 4. How they can effectively used in cytology? 5. What is the role of digital imaging in cytology? 6. How computers can help in PAP screening? 7. Role of informatics in cytology QA & QC 8. How to format information enhanced final report? 9. What is the future of cytology informatics? At the end of this session, you should be knowing O B J E C T I V E

PreTest:

PreTest 1. Who is the ultimate beneficiary of informatics? a. Clinicians b. Pathologists c. PG students d. Patients

PreTest:

PreTest 2. Cytology informatics is useful in a. Effective and efficient patient care b. Performance improvement of the lab c. Research d. All of the above

PreTest:

PreTest 3. Virtual microscopy refers to a. Whole slide imaging b. Static digital images c. Dynamic images d. Hybrid static and dynamic images

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PreTest 4. Automatic PAP slide screener address all the following, except a. Growing work load b. Cost containment c. Error reduction d. Shortage of lab technologists

PreTest:

PreTest 5. The main component of the comprehensive final report should be a. Inclusion of microscopic image b. Integration of turn around time c. Integration of all result data and final interpretation d. Integration of QC/QA data

What is informatics?:

What is informatics? The interdisciplinary, scientific field that studies and pursues the effective uses of biomedical data, information, and knowledge for Scientific inquiry, problem solving and decision making, motivated by Efforts to improve human health Raw Data Valuable Data Informatics

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Medical Data Technology Cost effective health care Happy Patients Appreciated Recognized Paid W e l l U n d e r

Informatics Tools:

Informatics Tools Electronic data mining & integration Tagging and tracking the specimen Digital imaging Net work sharing Let us see where it can be used?

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Followup Treatment Report release Transcription Reporting Screening Processing Accession Test Clinician Patient Patient Clinician 1 3 2a 2 2b 2c

Electronic data mining:

Electronic data mining Data input Data retrieval Data mining Improved reuse of data (QA/QC) Improvement in report quality GIGO

Data input:

Data input Should be able to trace the system to know the person involved in the process Critical value alert/flagging All retrospective data should be available in a screen before sign-out Final report should integrate and interpret all the available test results Minimum repetition of entries Easy pull down test orders Warning for double entry/unrelated tests Important fields made mandatory Possibility of adding new tests in under/post processing specimen

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QC & QA in cytology Ensure Accuracy Reliability Timeliness of reports QC: Product oriented specified criteria during Preparation Interpretation Reporting QA: Process oriented Anticipated reduction (not elimination) of false negative rate

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Informatics & cytology quality indicators Pre-analytical 1. Lab requisition completeness rate 2. Specimen transport time 3. Specimen rejection rate Analytical 1. Quality of QC slide Post -analytical 1. Work load (12.5 slides /hr & 100 slides/day) 2. Correlation with rescreening (10% negative slide to be rescreened by supervisor/pathologist) Work flow indicators 1. TAT Performance 1. ASCUS/SIL/HPV DNA result 2. Cyto-histo correlation 3. Retrospective review (5 yrs.) 4. Pre-sign out QC review 5. CME credit hours Data integrity 1. Net work security 2. Use of standardized format (Adequacy, Diagnosis, Description) Bench mark Outlier RCA CAPA Journey not Destination

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SMS alert/email Listing of pending cases TAT - Outliers -RCA -CAPA % of ASCUS - Pathologist/Institute Cyto-histo-correlation Other uses of Data Pathologist 1. Slides for review 2. Reports for release Clinician 1. Need for more history 2. Critical value alert 3. Availability of results 4. Need for more tests

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Pre-sign out QC review

Digital imaging:

Digital imaging High resolution Cameras/scanners High intra-internet bandwidth Fast and less expensive technology

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Clinical FNA adequacy at distant site Expert consultation Image enhanced report Automated cytology screening Before performing special studies Clinical Conferences Storage (legal requirement) Education Digital PG boxes Online digital atlases Research Digital image cytometry Quality issues Proficiency testing QA review Control slides Utility of digital imaging

Digital Imaging:

Digital Imaging Tele cytology Consultation Static Dynamic Operator controlled Reviewer controlled (robotic) Whole slide imaging (WSI) Virtual microscopy

Digital Imaging:

Features Static Dynamic WSI Acquisition Speed Quick Medium Slow Analysis speed Quick Slow Medium Sampling size Part Whole Whole Selection bias Yes No No Focus capable No Yes No Annotation Yes No Yes Magnification No Possible Possible Permanent Record Yes No Yes Digital Imaging

Report on TeleCytology:

Report on TeleCytology

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Loss/damage of slides (no recuts in cyto) Paperwork Transport Time delay Disruptive innovation Benefit to 1. Solo practicing pathologist 2. Boost the confidence of new pathologist 3. Subspecialty consultation 4. Assisting in working up a case 5. Interpret a special stain 6. Quality assurance for accreditation purpose

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Whole slide image

Computer screening system:

Computer screening system Conventional PAP smear 55 million/yr., abn. - 3.5 m. (6%) Simple, Low cost Reduced Ca. cervix by 70% Nov.2,1987 "Lax Laboratories: Hurried Screening of Pap Smears Elevated Error Rate of the Test for Cervical Cancer,” "cases of cancer missed due to excessive workloads of cytotechnologists, lack of quality control procedures, and poorly educated personnel". On Halloween 1988 Ronald Reagan signed CLIA ’88 ( Clinical Laboratory Improvement Amendments) The cytology proficiency testing mandated

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CLIA ’88 Increased work load Development of Computers for screening Not very good results Reasons Large surface area Obscured by blood, inflammation, debri Three dimensional smears - difficult to focus Liquid based cytology

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Liquid based cytology Advantages Limited surface area Monolayer of cells Additional smears possible (recuts..!!) Less of back ground noise Material available for other tests (HPV, Gonorrhea, Chlamydia) Disadvantages Cost Learning curve

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N Candida HSV LSIL HSIL TV

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Edinburgh study A.R.W. Williams, Cytopathology, Volume 17 , Issue 2 , pages 82–85 , April 2006

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Liquid-based cytology Name FDA approval ThinPrep ® 1996 BD SurePath ® 1999 MonoPrep ® 2006 Automated screening instruments 1. Primary screening without cytotechnologist interaction PAPNET: Adaptive computer processing (neural network) Ceased because of high cost BD FocalPoint slide Profiler BD SurePath Pap test 2. Interactive computer & cytotechnologist interpretation ThinPrep imaging system BD FocalPoint GS profiler 1. Scanning 2. Apply criteria 3. Score 4. Mark 5. Human review

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BD FocalPoint slide profiler 25% 15%

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ThinPrep imaging system Images viewed Automated microscope Computer screen

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Efficacy of computer screening systems

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Online Cytology - Use: Rural underserved areas Email Web pages Blogs Digital atlases Digital libraries

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Digital image cytometry Image based measurement of cells Image segmentation Feature extraction Analysis Objective & Highly reproducible Examples 1 . Measurement of DNA aneuploidy to differentiate LSIL vs HSIL 2. Sheffield quantitative criteria in cervical cytology (NC ration measurement) Largely investigational- further studies…...

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Summary of cytology digital imaging Advantages Elimination of glass slides Sharing by rapid transmission (telecytology, conference, QA, Peer review) Training, education, primary certification Maintenance of Proficiency Automated screening Disadvantages Increased cost Long time and large file size Ownership of material Lack of standardization & validation Medico-legal issues 1. Telecytology 2. Automated screening 3. Online cytology 4. Digital image cytometry

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---------- ---------- ---------- ---------- ---------- ---------- ---------- ---------- ---------- ------------------- ---------- Hospital name Demographics Clinical history Cyto Diagnosis ICD code Pathologist details HPV typing Prognostic data Future directions References Previous results Cyto images Clinician details Information Therapy

Future of cytology informatics:

Future of cytology informatics The best way to predict future is “to invent it” …….Look around to see what's happening in other fields…………..

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Online appointment Biometric /barcode patient ID Clinical examination Alert to pathologist LB specimen Accession in the lab Online test request CAD (computer aided diagnosis) Clinician result review Dictation in VRS PreSignout QC Abnormal cells Pathologist review Auto Processing Release of Neg.results Integration of results WSI Final impression Release of report Automatic screening Alert to clinician Clinician Meeting with Patient Treatment Result in inter/intranet Follow-up

Informatics - Caution :

Informatics - Caution Can it handle the volume of information? Is privacy and confidentiality maintained? Is back-ups available? Do you have disaster recovery plan? How many down times per week? ….how long?….why?

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Sit with your team List all the processes Plan for automation Good QA/QC Good backup Digital imaging Clinician feed back References in the report Suggests further steps If not sure, talk to the clinician Give your final impression Integrate lab findings Digital PG box Budget & Vendor Good data entry Outlier RCA/CAPA

PostTest:

PostTest 1. Who is the ultimate beneficiary of informatics? a. Clinicians b. Pathologists c. PG students d. Patients d

PostTest:

PostTest 2. Cytology informatics is useful in a. Effective and efficient patient care b. Performance improvement of the lab c. Research d. All of the above d

PostTest:

PostTest 3. Virtual microscopy refers to a. Whole slide imaging b. Static digital images c. Dynamic images d. Hybrid static and dynamic images a

PostTest:

PostTest 4. Automatic PAP slide screener address all the following, except a. Growing work load b. Cost containment c. Error reduction d. Shortage of lab technologists b

PostTest:

PostTest 5. The main component of the comprehensive final report should be a. Inclusion of microscopic image b. Integration of turn around time c. Integration of all result data and final interpretation d. Integration of QC/QA data c

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Cytojournal. 2009; 6: 6. Published online 2009 March 6. doi: 10.4103/1742-6413.48606 The impact of digital imaging in the field of cytopathology Liron Pantanowitz, Maryanne Hornish, and Robert A. Goulart J Pathol Inform. 2011; 2: 36. Published online 2011 August 13. doi: 10.4103/2153-3539.83746 Review of the current state of whole slide imaging in pathology Liron Pantanowitz, * Paul N. Valenstein, 1 Andrew J. Evans, 2 Keith J. Kaplan, 3 John D. Pfeifer, 4 David C. Wilbur, 5 Laura C. Collins, 6 and Terence J. Colgan 7 Cytojournal. 2008; 5: 16. Published online 2008 December 29. doi: 10.4103/1742-6413.44773 . Informatics applied to cytology Liron Pantanowitz, Maryanne Hornish, and Robert A. Goulart Modern Pathology (2010) 23, 349–358; published online 15 January 2010 Informatics for practicing anatomical pathologists: marking a new era in pathology practice Manal Y Gabril 1 and George M Yousef 2,3 6 1 5 4 3 2

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Michael J. Becich, M.D., Ph.D. John R. Gilbertson, M.D.

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What you can do for informatics…?? What informatics can do for you……..?? ….before asking…..

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T h a n k y o u

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