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Clinical Pathology 2010

History, Data and “Good Deeds Done”

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What is Clinical Pathology/Laboratory Medicine?

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Laborator(ies) – complex information to many

Information technology

Management and administration

Academic discipline (s)

Educational categor(ies)

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Evolution of Laboratory Medicine

Advances in Science and Technology

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Henry Bence Jones MoAb v K/L cryptic antigens

Kjeldahl reaction BUN

Adenosine deaminase - 1982 SCID - 2010

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Clinical Laboratories - UMHS

Virology - Pediatrics

HLA - Surgery

Cytogenetics - 2 laboratories

Coagulation - Internal Medicine

Molecular Dx - none until 1998

Stem Cell Lab - none until 2007

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Evolution of Laboratory Medicine

convergence toward an integrated lab

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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

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Technology

Ouchterlony, Radial immunodiffusion2 days 1 hour$400/9 patients $7/patient

AutomationChemistry LabHematology Lab

Direct immunofluorescence RT-PCRH1N1 Influenza A 2x/day; 7days/week

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Clinical Pathology Laboratories - 2010University Hospital

Specimen Processing MicrobiologySendout Laboratory 6 subsections

ChemistryPhlebotomy Unit (Home)

Therapeutic DrugsBlood Bank Toxicology

Apheresis/HPC Procurement EndocrinologyReference Lab Ligand AssaysGeneral Lab Automated SectionHPC Lab Special Chemistry

HematologyFlow Cytometry Mott HospitalGeneral Lab Virology Coagulation Lab

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Traverwood OffsiteMolecular 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)

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Clinical Pathology Faculty 2010Hematopathology Chemistry

Megan Lim Don GiacherioWill Finn Tom AnnesleyLauren Smith Jerry Menon (OB-Gyn)Lloyd StoolmanCharlie RossJay HessKojo Elenitoba-Johnson

Bert Schnitzer Blood Bank/Transfusion MedicineJason Cheng (4/1/10)

Rob DavenportLaura CoolingChisa Yamada

Microbiology/Virology

Duane Newton Sendout/Other

Steve Mandell

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Clinical Pathology Faculty 2010

Molecular Diagnostics Cytogenetics

Kojo Elenitoba-Johnson Diane RoulstonBryan Betz Lina ShaoTom Wilson Tom Glover (Human Genetics) David Ferguson Ram Iyer (Pediatrics)David LombardJeff Warren Immunopathology

Pan Zheng (Surgery) Jeff Warren

HLA Lab

Malek Kamoun (Univ. of Penn.)

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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

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10 Consecutive months: > 20,000 inpatient blood draws

Approximately 40% “First AM”

> 90% completed before 9 AM “complex draws” (phlebomist IIs)

2 consecutive months: No CSF Gram stain > 1 hour

80% ED cardiac markers < 1 hour> 1000/month

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How Does Clinical Pathology Operate? UMHS Administration

Pathology Administration

ManagementFinance/Capital EquipmentBilling (Professional/Facility)Human ResourcesOperationsQuality AssuranceSafety/Compliance

Pathology Informatics

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Laboratory Directors/Faculty

Supervisors’ Group (LCC)

Safety Committee

Quality Assurance

InspectionsExternalSelf-inspections

Clinical Lab Operations

Ad hoc

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Some Good Deeds Done

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UH (Inpatient) First AM Blood Draws

320-350/day (M-F)

Draws Completed Results posted

8 AM 81% 62%

9 AM 93% 87%

10 AM 96% 91%

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Who and How ?

Harry Neusius

Holly Eliot

many Phlebotomists

UM Ross School of Business (OMS 490)

William Lovejoy, Ph.D

4 great students

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B Cell Clonality EWSR1/WT1 Desmoplastic Small Round Tumor Translocation

BCR/ABL EWS/FLI1, EWS/ERG Ewing Sarcoma Translocation Detection

BRAF Factor V Leiden Mutation Detection

FLT3 Human Erythrocyte Antigen Genotyping

KIT Mutation Detection in Melanoma Hereditary Hemochromatosis Mutation Detection

JAK2 Methylenetetrahydrofolate Reductase C677T Mutation Detection

KITD816V NPM1 Mutation Detection

KRAS Prothrombin 20210 Mutation Detection

MSI t(X;18) SYT/SSX Translocation Detection

PML/RARA UGT1A1 Promoter Genotyping

T CELL gene rearrangement t(12;22) EWS/ATF1 Clear Cell Sarcoma Translocation Assay

BCR/ABL1 Kinase Mutation Analysis HER2 Amplification by FISH, Breast cancer

CEBPA Mutation Detection Urovysion by FIS, Bladder cancer

Apolipoprotein E Genotyping Warfarin Sensitivity Analysis

Bone Marrow Transplant Engraftment Analysis Kit Mutation Detection in GIST

Cystic Fibrosis Carrier Screening PAX/FOX01 Alveolar Rhabdomyosarcoma Translocation Detection

Molecular Diagnostic Laboratory

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Specimens Received and Turnaround TimeJanuary 2002 - December 2009

# Specimens TAT Linear (# Specimens) Linear (TAT)

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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 A H1N1

Oct. 18 235 90 All A

Oct. 25 307 125 All A

Nov. 1 308 107 All A

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Emergency Department Cardiac MarkerVolume and Turnaround Time

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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, et.al.: 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, et.al.: 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.

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The Future

New facilities/optimal function

Academic profile

Advances in service/technology 10-color flow cytometry Blood product “Sandwich” machines Epigenetic Profiling

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Thank You

Questions?