This presentation was presented by Chris Christopher at the Lab Quality Confab Conference on Nov 2, 2010. It shows how medical laboratories are using automation, technology and lean sigma improvement methodologies to meet organizational needs.

1. Chris Christopher
Vice President, Global Customer Solutions
Siemens Healthcare Diagnostics
Sharing a New Ideal:
How Tomorrow's Understaffed, Multi-Site Lab
Organization Will Combine Automation, Technology, and
Performance Improvement To Meet Its Mission

2. Page 2
Purpose & Objectives
PURPOSE
Provide an overview of the dynamics of today’s IVD industry with
emphasis on how tomorrow’s key organizations will be using
automation, technology, quality management and performance
indicators to raise the bar in meeting customer satisfaction.
OBJECTIVE
Gain insights into the dynamics of today's multi-site clinical laboratory
organization, the challenges it faces, and approaches used to
enhance performance in support of its mission.

3. Page 3
For Starters…
Similarities of High Performing
Labs to Auto Racing
Formula One Grand Prix Race
Drag Race
Daytona Race

4. Page 4
Market Segmentation: Similarity
Hospital Labs Grand Prix
 Average Speed  MEDIUM ~ 30 to 50% of Top End
 Peak Duration  Short to Medium Intervals
 Backup Capacity  Good
 Productivity  Medium
 KPI  STAT Turn Around Time

5. Page 5
Market Segmentation: Similarity
Reference Labs Daytona
 Average Speed  HIGH ~ 85% of Top End
 Peak Duration  Long
 Backup Capacity  Low < 25%
 Productivity  Very High
 KPI  Finish Line 0
200
400
600
800
1,000
1,200
1,400
1,600
0:00 2:00 4:00 6:00 8:00 10:00 12:00 14:00 16:00 18:00 20:00 22:00
Time of Day
Number of Total Samples
Checked Into ADVIA LabCell By Hour (May 6/7)

6. Page 6
Market Segmentation: Similarity
Emergency Labs Drag Strips
 Average Speed  Short Burst
 Peak Duration  Short
 Backup Capacity  Central Lab
 Productivity  Low
 Price Sensitivity  Low
 KPI  Turn Around “Time is Tissue”
0
2
4
6
8
10
12
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23
Hour Rcvd.
#Accessions

7. Today’s IVD Industry
Trends and Challenges in Multi-Site Lab
Combining Automation, Technology, and
Performance Improvement
Presentation Agenda
Workflows Discussion / Needs
Mission

8. The Lab is a Vital Contributor to the Healthcare
Network
Hospital
Hospital
Clinic
Healthcare
System
Affiliated
Physician
Practices
Patient’s
Home
Independent
Physician
Practices
Health
System
Physician
Practices
Laboratory
L-T Care
Surgi-Center
Imaging
Center
Outpatient
Rehab

9. Today’s IVD Market
 Approximately 70 percent of the medical decisions are based upon the
data obtained from laboratory testing performed by medical
technologist/clinical laboratory scientists. 1
Tests today are performed today in many locations:
 Clinical laboratory
 Physician Office
 Satellite locations
 Patient Home / Residence
 Increasing Pressure to
 Decrease Costs
 Improve Productivity / Quality / TAT
 Reduce Errors
Source:
The University of Southern
Mississippi Medical Technology

10. IVD Market Developments
Demand Drivers
Source:
American Association for Clinical Chemistry
LabTest Online® October 2010
1. Improve early detection and diagnosis of
diseases
2. Increase accuracy
3. Better predict outcomes (prognosis).
4. Improve productivity by automating methods

11. IVD Market Developments
 Rapid advancements in new tests driven by research,
personalized medicine, and tailored treatment
 New technology / methods
 Growing emphasis in Molecular and Genetic testing
 Expanding Point of Care
 Self testing for chronic sufferers
Fueling Growth
Source:
Boston Biomedical Consultants, Inc.
October 2010

12. Today’s IVD Industry
Trends and Challenges in Multi-Site Lab
Combining Automation, Technology, and
Performance Improvement
Presentation Agenda
Workflows Discussion / Needs
Mission

13. Trends & Challenges in Demand for Testing
$49,843.5m by 2016 at the CAGR of 4.3%
over the next seven years
DRIVERS:
1) New technological
advancements
2) A shift towards more
complex
immunochemistry tests
to Point of Care (POC)
3) The adoption of cost
cutting measures such
as increased
automation and self
testing.
Source:
GBI Research
January 2010CAGR (Compounded Annual Growth Rate)
IVD Anticipated Growth over Next 6 Years

14. Complexities in Laboratory Management
N. America
 Skilled Labor Shortages
 Attracting and retaining skilled labor
 Aging workforce
 Tight money supply
 Lack of Capital to Invest
 Little or no money to remodel
 Effective data management
 Need for integrated diagnosis
 Real-time management dashboard tracking metrics
 Partnering with Medical Staff to enhance patient care
C
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G
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S

15. Challenges in today’s laboratories worldwide
Error Reduction impacting Quality and
Performance
 Labeling at the Source of Collection
C
H
A
L
L
E
N
G
E
S

16. Today’s IVD Industry
Trends and Challenges in Multi-Site Lab
Combining Automation, Technology, and
Performance Improvement
Presentation Agenda
Workflows Discussion / Needs
Mission

17. Three Independent WORKFLOWS within the Clinical Laboratory
are Defined by Instrument
Order
Instrument
Data
Flows
Sample
Flows
Material
Flows
Results
Collect
Process
Store /
Retrieve /
Discard
Order
Inventory
Consume

18. Details on the FLOWS
 Specimen Collection
 Sample Sorting
 Physical Sample Transport
 Centrifugation
 Decapping
Sample
Flow
 Recapping
 Sample Archiving
 Sample Location & Retrieval
 Sample Disposal
 Sendouts
 Order Entry
 Electronic Medical Records
 Accessioning
 Quality Control
 Outreach
Data
Flow
 Autovalidation
 Result Review & Validation
 Decision Support
 Result Reporting
 Billing
 Instrument Inventory Mgmt
 Laboratory Inventory Mgmt
 Equipment Monitoring
 Equipment Maintenance
 Remote Service
Material
Flow
 eCommerce
 Utilization Reporting
 Cost Per Result Management
 Automated Invoicing
 Electronic Payment
Instruments /
Automation
Chemistry
Immunoassay
Hemostasis
Hematology
Microbiology
All other
The Lab is a highly complex 24/7 business with many inputs and outputs!!!

19. Workflow Optimization Using Quality Management Tools
 “Rapid Improvement Event”
Focus: Eliminate Waste
Key Tool: Value Stream Map
Look for: Consolidation of Processes
Promote: Continuous Flow vs. Batch
Resources: Cross functional team
Optimize processes in the ED and LAB using Lean /
Six Sigma Quality Management Solutions
Sample Flows Lab Patient Flows
ED
Information
Flows

20. Today’s IVD Industry
Trends and Challenges in Multi-Site Lab
Combining Automation, Technology, and
Performance Improvement
Today’s Agenda
Workflows Discussion / Needs
Mission

21. Today’s Best Practice Laboratory is
Driving …
… Process Improvement across the
Healthcare Network

22. Example #1 – Focus on Performance
Improvements
Healthcare Innovation:
“Getting It Right: Perfecting the Patient Experience,”
has been a key factor in reducing waste in our system and
improving the bottom line, while at the same time it has
enhanced efficiency and ensured continued high quality of
care.”
Source:
Denver Health
2008/09 Annual Reports
Uncompensated care increased from $318 million in
2008 to $362 million in 2009
“Denver Health’s Response to Rising Cost”

23. Example #1
“Denver Health’s Response to Rising Cost”
Example Healthcare Innovation:
Source:
Denver Health
2008/09 Annual Reports
“A good deal of credit for our success in remaining financially viable this
year goes to our LEAN initiative, which, through process improvement
efforts, has reduced waste in every corner of our health care delivery
system. Using the principles of LEAN, employees throughout the
enterprise joined together in three to five cross-departmental groups twice
each month, and focused attention on specific areas in which waste can
be removed. In 2009, the initiative gained significant momentum, and $24
million of the $42 million total financial benefit occurred in this
year alone.
One significant source of pride emanating from our transformation project
is our unique development of an internal corps of LEAN Black Belt
experts – the only one of its kind in the nation. We have trained
200 employees, from surgeons to mid-level managers, in the principles
of LEAN. They then look to reduce waste every day in their departments.
Black Belt projects accounted for $8.8 million of the total $42 million in
financial benefit.

24.  Lean Quality Management Driven
 Visual Cues; Measurements; Priority Management
 Effective Use of Non Technical Labor
 Electronic Archival Tracking for Central Lab
 Auto Verification and Auto Release
 Smiling Faces
Best Practices  Overall Operation
Note worthy: Denver Health operates a Highly Complex Clinical Diagnostics Lab
with ~100s customized order capability and multiple priorities...
SpecTRACK

25. Best Practices  KPI: In Lab Turn Around Time
• In Lab Commitment: 30 minute TAT at 90th percentile
(Most Labs in N. America: 45 to 60 mins. For Troponin)
Troponin Turnaround Times, Average
0
10
20
30
40
50
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
Month
Minutes
2008
2009
2010
• In Lab Monitoring for Chemistry:
STAT Alert > 20 minute TAT

26. Page 26
26
Focus on Continuous Performance Improvement
Example: Lean Project Plan and Summary
# Name/Description Lead Start
Date
End
Date
JDI
RIE
Project
5 Outpatient Charge Capture – Facility
Billing
Billing 9/13/10 X
2 Outpatient Lab Ordering Order Entry 10/11/10 X
5a Physician Billing Charge Capture Billing 11/8/10 X
1 CHS Outpatient Flow Operations 12/13/10 X
1a Pre-analytical Standard Work Lab 1/10/10 X
9 Specimen Collection Standard Work Lab 8/1/10 8/1/11 X
12 Resulting Standard Work Lab 2/7/11 X
18 Specimen Management Lab 8/1/10 12/31/10 X
16 Anatomic Pathology Standard Work AP 3/7/11 X
13 IT/Lab Optimization IT / Lab 4/4/11 X
14 Hazardous Materials – RCRA Operations 8/2/10 8/2/10 X

27. Example #2 – Solving Tough Problems in Operations
Source:
April Gamache
Sr. Vice President Operations
October 2010
“Driving Operational Excellence Daily”
 Provides > 50 millions lab tests to over 10 million
patients and nearly 20,000 physicians in Canada
 Toronto Lab Processes more than 18K Samples
per day in Chemistry with installation of a Single
Line Automation in 2008
 Continuous Operations 24/7
 Faces Labor Shortages
 Highly Regulated
 Quality Focused

28. Example #2 – Solving Tough Problems in Operations
Underlying Strategies to “Driving
Operational Excellence”
 Establish an Environment of Continuous Improvement
 Establish a Common Language & Tool Kit
 Implement Rigorous Measurement Processes – Start with the Facts
 Learn from Mistakes
 Adopt Best Practice (UPS for tracking samples)
 Improve Capabilities to Solve Problems as they are identified
 Create an Organization of Mentors
 Expand Knowledge within the organization Source:
April Gamache
Sr. Vice President Operations
October 2010

29. Combining Automation, Technology, and
Performance Improvement
Value Stream Map – Optimize Processes -- Automate – Measure
– Workload Balance – Seek Further Improvement
Balance
Load
Tools
Process
Environment/Materials
People
Knowle dge L ev el
Clea r Roles for Tray Managem ent
Av ailability of L abour
L oading Protocol
Visual ID of Deliv ery & Balance Issues
Gate Scanners
Throughput Capability
Queue Design
Routing L ogic
Hours of Operation
Tray Configuration
L ine Configuration/L ay out
Test Density
Test Mix
Tube Mix (load sensitiv e)
SM L oading Protocol
Tray Configuration Work Instruction
Downtim e
Dashboard
Throughput Ca lculator
Sim iulation Tool
Throughput Data
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30. Lab Operations Dashboard
30
Visual management of
the automation line
• Expected levels of tube
processing allows
technologists & technicians
the ability to identify
problems before they impact
expected specimen turn-
around times
• The red/yellow/green
indicators also indicate
severity of the issues and
prompt the right response
for lab personnel to take with
the system

31. Specimen Management Dashboard
31
• “Web portals were
established to provide real-
time receipt of specimens by
the various types required to
be resulted”
• “This enabled operations
group to identify potential
backlogs that could occur
and take appropriate action
to resolve”
Michael Hartman
Lean Sigma Master
Black Belt

32. Focus on Process Improvement
32
Instrument Downtime
Centaur Chemistry
Track Sample Mangers
Probes/Tubing
Heaters/Thermistors
Probes
Barcode Readers H/W
Cx Errors
Belt/Drive H/W
Robot Arm
QC Issues
Mixers
Switches
DPP
ISE Issues
Gates/Diverters H/W
CentraLink
Scheduled Maintenance
Scheduled Service Maint.
PM’s
Software Mgmnt
SPP
RPP1,2
DTT Hardware
Pumps
Fluidics
Optics
Software
User
Electronics
Cooling
Computer
Software
Settings
Patches
Communication
Ancillary Queue
Ribbon Cables
Tip Drawer H/W
RP1/2
RT
Computer H/W
General H/W
Belts
Luminometer
Ring
Vacuum
Plugged Lines
26
26
4
9
4
• “With the automation taking
care of processing,
operations could focus on
identifying issues with
capacity”
• “Lean Sigma played a
critical role in unlocking the
true capacity of the platform
and providing a framework
for ongoing improvement”
Root Cause Analysis
Michael Hartman
Lean Sigma Master
Black Belt

33. These are two great examples of where Multi-Site Lab
Organization are Combining Automation, Technology,
and Performance Improvement To Meet Its Mission
Chartering the Future

34. Looking ahead … where’s the next major
opportunity

35. As an Industry, we must solve Today’s Complex
Connectivity and….

36. Meet the Laboratory’s Needs with a Common Language for
Communications that contributes to Efficient Process Control
i2i
A Common Language for Communication
between Instruments and IT

37. The Lab’s Formula for Success
Thank You
Driving Hard while
Combining Automation,
Technology, and
Performance Improvement