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