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1 Clinical Pathology 2010 History, Data and Good Deeds Done.

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Presentation on theme: "1 Clinical Pathology 2010 History, Data and Good Deeds Done."— Presentation transcript:

1 1 Clinical Pathology 2010 History, Data and Good Deeds Done

2 2 What is Clinical Pathology/Laboratory Medicine?

3 3 Laborator(ies) – complex information to many Information technology Management and administration Academic discipline (s) Educational categor(ies)

4 4 Evolution of Laboratory Medicine Advances in Science and Technology

5 5 Henry Bence Jones MoAb v K/L cryptic antigens Kjeldahl reaction BUN Adenosine deaminase - 1982 SCID - 2010

6 6 Clinical Laboratories - UMHS Virology -Pediatrics HLA-Surgery Cytogenetics-2 laboratories Coagulation-Internal Medicine Molecular Dx-none until 1998 Stem Cell Lab-none until 2007

7 7 Evolution of Laboratory Medicine convergence toward an integrated lab

8 8 Regulatory JCAHO CLIA CAP FDA FACT AABB ASHI Information Technology >5,000,000 discrete results/year Logistics QA/QC Billing Interpretation Management 520 employees $420M charges

9 9 Technology Ouchterlony, Radial immunodiffusion 2 days 1 hour $400/9 patients $7/patient Automation Chemistry Lab Hematology Lab Direct immunofluorescence RT-PCR H1N1 Influenza A2x/day; 7days/week

10 10 Clinical Pathology Laboratories - 2010 University Hospital Specimen ProcessingMicrobiology Sendout Laboratory 6 subsections Chemistry Phlebotomy Unit (Home) Therapeutic Drugs Blood Bank Toxicology Apheresis/HPC Procurement Endocrinology Reference Lab Ligand Assays General Lab Automated Section HPC Lab Special Chemistry Hematology Flow Cytometry Mott Hospital General Lab Virology Coagulation Lab

11 11 Traverwood Offsite Molecular Diagnostics 8 Clinical Labs HLA Lab Immunology Cytogenetics Other Blood Gas Lab (Resp Ther) Cystic Fibrosis Lab (Peds) Medical Science I Burn Unit Lab (Surgery) Molecular (Pediatrics)/Biochemical Michigan Translational (AC) POCT (UMHS)

12 12 Clinical Pathology Faculty 2010 HematopathologyChemistry Megan Lim Don Giacherio Will Finn Tom Annesley Lauren Smith Jerry Menon (OB-Gyn) Lloyd Stoolman Charlie Ross Jay Hess Kojo Elenitoba-Johnson Bert Schnitzer Blood Bank/Transfusion Medicine Jason Cheng (4/1/10) Rob Davenport Laura Cooling Chisa Yamada Microbiology/Virology Duane Newton Sendout/Other Steve Mandell

13 13 Clinical Pathology Faculty 2010 Molecular DiagnosticsCytogenetics Kojo Elenitoba-Johnson Diane Roulston Bryan Betz Lina Shao Tom Wilson Tom Glover (Human Genetics) David Ferguson Ram Iyer (Pediatrics) David Lombard Jeff Warren Immunopathology Pan Zheng (Surgery) Jeff Warren HLA Lab Malek Kamoun (Univ. of Penn.)

14 14 Clinical Pathology – Scope and Facts (2009) 5.1 Million Tests $450 Million – Gross Revenue 522 FTEE (includes phlebotomy) 51,000 Square feet (net) $14 Million – blood product cost $55.2 Million – Operating Expense (2009) $84,000 Proficiency Testing material costs

15 15 10 Consecutive months: > 20,000 inpatient blood draws Approximately 40% First AM > 90% completed before 9 AM complex draws (phlebomist II s) 2 consecutive months: No CSF Gram stain > 1 hour 80% ED cardiac markers < 1 hour > 1000/month

16 16 How Does Clinical Pathology Operate? UMHS Administration Pathology Administration Management Finance/Capital Equipment Billing (Professional/Facility) Human Resources Operations Quality Assurance Safety/Compliance Pathology Informatics

17 17 Laboratory Directors/Faculty Supervisors Group (LCC) Safety Committee Quality Assurance Inspections External Self-inspections Clinical Lab Operations Ad hoc

18 18 Some Good Deeds Done

19 19 UH (Inpatient) First AM Blood Draws 320-350/day (M-F) Draws CompletedResults posted 8 AM81%62% 9 AM93%87% 10 AM96%91%

20 20 Who and How ? Harry Neusius Holly Eliot many Phlebotomists UM Ross School of Business (OMS 490) William Lovejoy, Ph.D 4 great students

21 21 B Cell ClonalityEWSR1/WT1 Desmoplastic Small Round Tumor Translocation BCR/ABLEWS/FLI1, EWS/ERG Ewing Sarcoma Translocation Detection BRAFFactor V Leiden Mutation Detection FLT3Human Erythrocyte Antigen Genotyping KIT Mutation Detection in MelanomaHereditary Hemochromatosis Mutation Detection JAK2Methylenetetrahydrofolate Reductase C677T Mutation Detection KITD816VNPM1 Mutation Detection KRASProthrombin 20210 Mutation Detection MSIt(X;18) SYT/SSX Translocation Detection PML/RARAUGT1A1 Promoter Genotyping T CELL gene rearrangementt(12;22) EWS/ATF1 Clear Cell Sarcoma Translocation Assay BCR/ABL1 Kinase Mutation AnalysisHER2 Amplification by FISH, Breast cancer CEBPA Mutation DetectionUrovysion by FIS, Bladder cancer Apolipoprotein E GenotypingWarfarin Sensitivity Analysis Bone Marrow Transplant Engraftment AnalysisKit Mutation Detection in GIST Cystic Fibrosis Carrier ScreeningPAX/FOX01 Alveolar Rhabdomyosarcoma Translocation Detection Molecular Diagnostic Laboratory

22 22

23 23 RT – PCR - H1N1 Influenza A - UMHS TAT : 14 days – 3.5 days - < 24 hour (9/27/09) 2 runs/day; 7 days/week Peak weeks Specimens Flu AH1N1 Oct. 18 235 90All A Oct. 25 307 125All A Nov. 1 308 107All A

24 24

25 25 Finn WG, Carter KM, Raich R, Stoolman L, Hero A: Analysis of Clinical Flow Cytometric Immunophenotyping Data by Clustering on Statistical Manifolds: Treating Flow Cytometry Data as High-Dimensional Objects. Cytometry Part B (Clinical Cytometry) 76B:1-7 (2009). Lim MS, Carlson ML, Crockett DK, Fillmore GC, Abbott DR, The proteomic signature of NPM/ALK reveals deregulation of multiple cellular pathways. Blood 2009 114: 1585-1595. Cooling L, Hoffmann S, Herrst M, Muck C, A prospective randomized trial of to popular mononuclear cell collection sets for autologous peripheral blood stem cell collection in multiple myeloma. Transplantation and Cellular Engineering 50: 100-119, 2010.

26 26 The Future New facilities/optimal function Academic profile Advances in service/technology 10-color flow cytometry Blood product Sandwich machines Epigenetic Profiling

27 27 Thank You Questions?

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