Transcript Clinical Pathology 2010

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 
Kjeldahl reaction
MoAb v K/L cryptic antigens
 BUN
Adenosine deaminase - 1982 
SCID - 2010
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Clinical Laboratories - UMHS
Virology
HLA
Cytogenetics
Coagulation
Molecular Dx
Stem Cell Lab
-
Pediatrics
Surgery
2 laboratories
Internal Medicine
none until 1998
none until 2007
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Evolution of Laboratory Medicine
convergence toward an integrated lab
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Regulatory
JCAHO
CLIA
FDA FACT
CAP
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 immunodiffusion
2 days

1 hour
$400/9 patients $7/patient
Automation
Chemistry Lab
Hematology Lab
Direct immunofluorescence RT-PCR
H1N1 Influenza A
2x/day; 7days/week
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Clinical Pathology Laboratories - 2010
University Hospital
Specimen Processing
Sendout Laboratory
Microbiology
6 subsections
Chemistry
Phlebotomy Unit (Home)
Blood Bank
Apheresis/HPC Procurement
Reference Lab
General Lab
HPC Lab
Hematology
Flow Cytometry
General Lab
Coagulation Lab
Therapeutic Drugs
Toxicology
Endocrinology
Ligand Assays
Automated Section
Special Chemistry
Mott Hospital
Virology
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Traverwood
Molecular Diagnostics
Offsite
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 2010
Hematopathology
Megan Lim
Will Finn
Lauren Smith
Lloyd Stoolman
Charlie Ross
Jay Hess
Kojo Elenitoba-Johnson
Bert Schnitzer
Jason Cheng (4/1/10)
Chemistry
Don Giacherio
Tom Annesley
Jerry Menon (OB-Gyn)
Blood Bank/Transfusion Medicine
Rob Davenport
Laura Cooling
Chisa Yamada
Microbiology/Virology
Duane Newton
Sendout/Other
Steve Mandell
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Clinical Pathology Faculty 2010
Molecular Diagnostics
Kojo Elenitoba-Johnson
Bryan Betz
Tom Wilson
David Ferguson
David Lombard
Jeff Warren
Cytogenetics
Diane Roulston
Lina Shao
Tom Glover (Human Genetics)
Ram Iyer (Pediatrics)
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
522
51,000
$14
$55.2
$84,000
Million – Gross Revenue
FTEE (includes phlebotomy)
Square feet (net)
Million – blood product cost
Million – Operating Expense (2009)
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
Management
Finance/Capital Equipment
Billing (Professional/Facility)
Human Resources
Operations
Quality Assurance
Safety/Compliance
Pathology Informatics
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Laboratory Directors/Faculty
Supervisors’ Group (LCC)
Safety Committee
Quality Assurance
Inspections
External
Self-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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Molecular Diagnostic Laboratory
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
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Specimens Received and Turnaround Time
January 2002 - December 2009
1400
10
9
1200
8
7
6
800
5
600
4
3
400
2
200
TAT (days)
Specimens Received per Month
1000
1
0
January
2002
0
July
2002
January
2003
July
2003
January
2004
July
2004
January
2005
July
2005
January
2006
July
2006
January
2007
July
2007
January
2008
July
2008
January
2009
July
2009
Month/Year
# 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
Nov. 1
307
308
125
107
All A
All A
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Emergency Department Cardiac Marker
Volume and Turnaround Time
1400
Monthly Volume
1200
TAT
1000
> 2 hours
800
1-2 hours
<1 hour
600
400
200
0
Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
2008
2009
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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?
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