Lean Six Sigma in the Lab Kansas City CLMA Friday, March 1, 2013
Microbiology Automation A New Frontieruserfiles/pdfs/CLMA Micro Automation 2015.pdfMicrobiology...
Transcript of Microbiology Automation A New Frontieruserfiles/pdfs/CLMA Micro Automation 2015.pdfMicrobiology...
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Microbiology Automation
A New Frontier
Terri Riddle, MBA, MLS(ASCP)
MicroScan Global Marketing
Global Process Consultant
Beckman Coulter, Inc.
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Disclosures
I am an employee of Beckman Coulter, Inc.,
a distributor of Copan WASP/WASPLab.
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Agenda
� What is microbiology automation?
� Digital microbiology work flow
� Impact of automation and financial justification
� Questions
Learning Objectives
� Learn about the key features, benefits, and impact of
microbiology automation systems
� Describe how work flow will change with digital microbiology
� Understand strategies to financially justify micro automation
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Continued
decrease in
reimbursement
Retirements
and staffing
challenges
Outsourcing
and
consolidation of
micro testing
Increased
demand
for
automation
Challenges of
antimicrobial
resistance
Customer Challenges and Needs
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Today’s Microbiology Processes
OtherBlood
Culture Gram StainEnrichment Molecular Other
Read Cultures
ID/AST
Spot Tests
Blue = largely automated
Red = partly automated
Grey = largely manual
No Growths Normal Flora Pathogen
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With Future Automation Solutions
OtherBlood
Culture Gram StainEnrichment Molecular Other
Read Cultures
ID/AST
Spot Tests
Blue = largely automated
Red = partly automated
Grey = largely manual
No Growths Normal Flora Pathogen
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The First Challenge for Micro Automation
� Different containers
� Different sizes and caps
� Different sample viscosities
� Different processing protocols
� Variability in bar code placement
Micro Automation Requires Liquid Specimens
Photo © 2012 Copan Diagnostics, Inc. All rights reserved.
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Flocked Swabs – Quality and Flexibility
� Up to 48 hours organism viability* for aerobes, anaerobes & fastidious organisms
� Gram stains, traditional culture, PCR and rapid antigen assays
� Automation ready*Product tested and validated full in compliance with CLSI M40-A: Quality Control
Microbiological Transport Systems, including Neisseria gonorrhea survival at 24 hrs
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Liquid Sputum Specimens?
� SL Solution - A mucolytic reagent that transforms sputum into liquid format
� Allows easier and more consistent planting and streaking.
� Does not affect morphology or growth of pathogens
� Room temperature stability
Photo © 2012 Copan Diagnostics, Inc. All rights reserved.
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� Pre-analytical specimen processor
� Full micro automation
� Conveyor track
� Robotic incubation
� Digital imaging
� Reading and work up benches
Components of Micro Automation Systems
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� Pre-analytical specimen processor
� Full micro automation
� Conveyor track
� Robotic incubation
� Digital imaging
� Reading and work up benches
Components of Micro Automation Systems
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Evolution of Specimen Processors
ISOPLATER 180
This photo is the exclusive right of Vista Technology, Inc
� Operator manually inoculates and labels plates
� Plates are loaded onto the system
� ISOPLATER® streaks plates in a circular pattern using a series of patented “S” shaped loops to achieve colony isolation
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Evolution of Specimen Processors
Previ Isola
This photo is the exclusive right of bioMerieux, Inc
� Operator loads specimens that have been manually mixed and decapped
� Instrument automatically inoculates liquid specimens using disposable pipette tips
� Disposable combs streak for isolation using a circular pattern
� Plates are automatically labeled
Previ™ Isola is a registered product of bioMerieux, Inc.
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Evolution of Specimen Processors
InocuLAB
This photo is the exclusive right of Dynacon Inc
� One of first systems to automate the decapping and recapping of specimens
� Manual mixing still required
� Calibrated metal loops used for sampling and streaking
� Automatic plate labeling
� Note: InocuLAB is no longer sold
InocuLAB™ is a registered product of Dynacon Inc., Ontario, CA
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Evolution of Specimen Processors
BD Innova
� Based on the InocuLAB platform, but with added features
� Innova™ automatically processes urine, ESwab, and fecal Carey Blair samples
� Can sample with either a disposable pipette or a reusable metal loop
� 5 specimens drawers can be accessed independently
This photo is the exclusive right of Becton Dickinson Inc
Innova™ is a registered product of Becton Dickinson Inc.
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Next Generation Specimen Processors
� Automates all the core aspects of specimen processing
� Identifies and tracks specimens with bidirectional LIS interface
� Fully automates mixing, inoculation and streaking
� Inoculates plates and broths
� Applies discs – both direct specimens and Kirby Bauer
� Prepares and labels Gram slides
� Can automate up to 95% of culture specimens
� Engineered for stand alone specimen processing or as part of a complete micro automation line
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This photo is the exclusive right of BD Kiestra B.V.
Next Generation Specimen Processors
BD Kiestra InoqulA
InoqulA® is a registered product of BD Kiestra B.V. Friesland, Netherlands
� Consists of 2 modules – fully automated and semi-automated
� Pipette tips deliver inoculum
� Unique streaking method using rolling balls
� Customer defined streak patterns
� Streaks up to 5 plates simultaneously
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Next Generation Specimen Processors
Copan WASP: Walk Away Specimen Processor
� Fully automated and “streak only” modes
� Random loading of pallets
� Reusable metal loops - 1 µL, 10 µL, 30 µL, plus dual biplate loop
� Customer defined streak patterns
� Camera system and image analysis ensure planting
� Unique spinner to automate processing of fecal specimens
Photo © 2012 Copan Diagnostics, Inc. All rights reserved.
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� Pre-analytical specimen processor
� Full micro automation
� Conveyor track
� Robotic incubation
� Digital imaging
� Reading and work up benches
Components of Micro Automation Systems
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Complete Microbiology Automation Systems
This photo is the exclusive right of BD Kiestra B.V.This photo is the exclusive right of BD Kiestra B.V.
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Components of Microbiology Automation
Conveyor Tracks
� Transport plates
� From the specimen processor to the incubators
� From incubators to work up canisters or to work stations
� Bar code readers along track ensure placement in the proper incubator
� Configuration of line depends on work flow preference and space availability
Photo © 2012 Copan Diagnostics, Inc. All rights reserved.
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Components of Microbiology Automation
Robotic Incubators
� High capacity storage (854-1708 plates) in a small footprint
� Automated plate management using side bar code label
� Optimal environmental conditions support rapid growth
� Individual plate shelves have good thermal conductivity, allowing plate to quickly come up to appropriate temperature
� No disruption of temperature or CO2
from manually opening doors
� Robotic inversion of plates is possible
Photo © 2012 Copan Diagnostics, Inc. All rights reserved.
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Impact of Consistent Optimal Environment
Micro Activity
Conventional
Reading Time
WASPLab
Reading Time*
Culture set up at 0 hours Not performed Baseline image
1st read 18-24 hours 14-16 hours
2nd read Appx 48 hours 30 hours
3rd read Appx 72 hours 52 hours
4th read Appx 96 hours 78 hours
* Based on active WASPLab installations; may vary
based on system validation and customer preference
A consistent optimal environment, combined with strategic staffing and reading practices, can contribute
to a significant decrease in turnaround times.
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Components of Microbiology Automation
Digital Imaging
� Digital camera captures images of plate
� Various lighting scenarios can be used
� Images can be taken at specified intervals
� Image quality ranges from 5 – 27 megapixels depending on the system
� Enlarge image to show colony detail
� Evaluate colonial morphology
� Unique WASPLab Time0 image will allow differential analysis
� Chromogenic markers1
� Growth vs. No Growth1
Photos © 2012 Copan Diagnostics, Inc. All rights reserved.
1 Under development; not yet available for sale in US
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July 2013 Riddle/ MM Global Marketing
Compare growth over time Enlarge for detail
Select the optimal lighting scenario
Digital Imaging
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Components of Microbiology Automation
Reading and Picking Stations
� Work flow will change with digital microbiology
� Majority of culture analyses will be performed using a computer monitor
� Plates requiring work up or further investigation are automatically moved out of the robotic incubator for manual picking
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Screening
Functions
Reading
Functions
Picking
Functions
� Rapidly sort negative
from positive cultures
� WASPLab
automatically organizes
plates based on
amount of growth
� Detect suspect
colonies on
chromogenic agar
� Screen 800-1200
plates per hour*
� Detailed analysis of
positive cultures to
define appropriate
work up
� Create electronic
work up tickets
� Report results
� Read 100 plates
per hour*
� Only time the plates
are manually touched
� Perform tasks defined
on work up ticket
� Provides a valuable
quality check on
reader’s interpretation
� Pick 80 plates per
hour*
* Performance reported by established WASPLab installations
WASPLab Workflow
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Screening Functions
� Quickly scan images to sort negative cultures from the positive cultures that require more detailed analysis
� Typically used for urine cultures, chromogenic agar screening, and other simple culture types
� Screen multiple images which are sorted by biomass
� Work flow benefits
� Move positive cultures to reading phase quickly
� Efficient resulting of negative cultures
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Reading Functions
� Analyze cultures to define appropriate work up
� Observe growth over time and under various lighting scenarios
� Enlarge image for better visualization of growth
� Identify colonies that require further analysis and create electronic work tickets
� Result culture finding in the LIS
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Picking Functions
� Perform tasks defined on work up tickets
� Easily document completion of task to remove it from the work list
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Conventional vs. Digital Work Flow
Process Conventional Micro (Typical Lean work flow)
Digital Micro
Reading
Functions
- Benches typically divided
by type of culture: urine, wound, etc.
- Each bench tech reads,
results, and picks every culture
- Work functions divided
between READERS and PICKERS
- Readers – Perform digital
analysis and resulting
Picking
Functions
N/A - Pickers – Designated techs
perform all “hands on” tasks
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What Does the Future Hold?
Features Under Development1
� Automated Growth vs. No Growth resulting
� Kirby Bauer halo recognition and interpretation
� Early positive growth notification for critical cultures
� Automated picking, to include
� Inoculation of Prompts and turbidities
� MALDI target spotting
� Subcultures from plated cultures
� Integration of Gram slide images
� Integration of front end processor onto central lab automation line
� Integration of instruments onto micro automation line
1 Under development; not yet available for sale in US
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Impact of Microbiology Automation on Productivity
% Improvement in Productivity
With Microbiology Automation
0%
50%
100%
150%
200%
250%
300%
Lab 1 Lab 2 Lab 3
Labs 1 and 2 – Automation in Clinical Microbiology,
J. Clin. Microbiol. June 2013, vol. 5 no. 6 1658-1665
Lab 3 – Copan Italia (unpublished data), 2013
Demonstrated increases in productivity, by as much as 2.5-fold to 4-fold, have been reported by laboratories adopting microbiology automation.1
1 Automation in the Clinical Microbiology Laboratory, Clin Lab Med 33 (2013)
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Impact of WASP on Productivity:
Specimen Processing
Source: Nexus work flow evaluation –
University of Kentucky Healthcare, February 2015
� Full WASP integration resulted in a 74% decrease
in manual labor related to
specimen processing� This calculates as a
decrease of 98 manual
labor hours per month
Average Hands On Time
Pre-WASP With WASP
82 sec 21 sec
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Impact of WASPLab on Productivity:
Estimated Staffing Impact for Analytical Activities
Current Staffing by Reading Bench
Hours per Day
Urine 18-26 hrs
Respiratory 8 hrs
Wound/MDR/ear/eye 18-26 hrs
Genital 12 hrs
TOTAL 56-72 hrs/day
With WASPLab - Typical Busy Day
Hours per Day
Screening (only urine,MRSA, VRE, and SA) 1.8 hrs
Reading (positive screens
and all other cultures) 29.8 hrs
Picking 8.3 hrs
TOTAL 39.9 hrs/day
Assumptions:
� Based on productivity metrics more
conservative than those seen in existing
WASPLab microbiology laboratories
� Screening – 600 plates per hour
� Reading – 80 plates per hour
� Picking – 60 plates per hour
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Strategies for Financial Justification
� Improve productivity to address:
� Increasing volumes
� Staffing challenges
� Lab consolidation
� Improve turnaround time
� Faster growth of cultures in controlled environment
� Supports 24/7 reading and resulting
� “Read when ready” philosophy
� Support antimicrobial stewardship and improved patient outcomes
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Courtesy of Sandra Mills, Chief Microbiology Technologist, UK Healthcare
2013 data is annualized.
The Case for Antimicrobial Stewardship
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Courtesy of Sandra Mills, Chief Microbiology Technologist, UK Healthcare
QA study comparing length of incubation at initial culture read to MIC TAT
Average MIC TAT
Incubation period 12-18 hrs
Average MIC TAT
Incubation period <12 or >18 hrs
<2 days 3.5 days
Improve TAT with “Read When Ready” Analysis
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Maximize Impact of Micro Automation
On Patient Care
� 24/7 reading to minimize TAT of clinically significant results
� Use of MALDI-TOF for rapid identification
� Molecular platform to detect known resistance mechanisms
� Accurate MIC platform to detect newly emerging resistance
� Active antimicrobial stewardship program
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Benefits of Microbiology Automation
� Automate routine tasks, e.g. sorting plates
� Eliminate manual transport of plates to and from
incubators, to and from reading benches, etc.
� Streamline analysis and resulting of cultures
� Better visualization of growth with digital imaging
� Simplified supervisory review to ensure accuracy
� Enhanced opportunities for teaching and consultation
� Faster growth in the controlled incubator environment
allows earlier culture reading
� “Read when ready” images support 24/7 reporting
� Software can streamline documentation
Increase
Productivity
Improve Quality
Decrease
Turnaround Time
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Questions?
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© 2013 Beckman Coulter, Inc.
Move Your Lab Forward with
Beckman Coulter
Contact with Disclaimer
Terri Riddle, MBA, MLS(ASCP)
MicroScan Global Marketing
Global Process Consultant
Beckman Coulter, Inc.
1. MicroScan is a trademark of Beckman Coulter, Inc. All other trademarks are properties of their respective owners.
2. Product availability may vary from country to country and is subject to varying regulatory requirements.
3. Beckman Coulter, Inc. is an authorized distributor of the Copan WASP System and the BrukerMALDI Biotyper System. Copan and Bruker are Strategic Alliance Partners of Beckman Coulter, Inc.