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Using Lean to Integrate MALDI TOF into a high volume Microbiology Lab
David Chow Manager
Agenda BC Biomedical Laboratories Ltd
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•! Sex •! Trekkies •! East Coasters vs. West Coasters •! Canadians/Americans •! Bodily Fluids •! Chemistry/Hematology
PG -13 Warning!
•!Presenter has stocks in Bruker Daltonics and BioMerieux
•!Purchased September 2008
•!Presenter diversified retirement plans now include hockey pools and Canadian prince email schemes
Disclosure
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Majority of initial screening performed by biochemicals made in house
•! Low cost. •! 16-48 hour TAT for final identification.
Current State of Microbiology Biochemical utilization/fermentation
Commercial Identification System •! Miniaturized tubes using same principle. •! 7 hour TAT for final identification. •! $250K hardware •! $230K reagent cost increase/yr •! 1.0 FTE labour increase
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MALDI TOF Matrix Assisted Laser Desorption Ionization Time Of Flight
Spot the organism onto target plate.
Add matrix solution to the spot.
Laser flash ionizes the matrix. Organism molecules are ionized by proton transfer from matrix
Ions of different sizes travel through tube. Time measured (Time of Flight Spectra generated Spectra compared to database
Same day TAT for identification will have many benefits.
•! Reduce Stool Culture TAT by one day
•! Reduce Mycology TAT by weeks.
•! Same day TAT for positive blood cultures
•! Better utilization of antibiotics.
MALDI TOF
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Options for Identification
BC Bio Commercial ID System
MALDI TOF
Hardware Costs n/a $250K $250K
Reagent Cost/test $1-$8 $6 <$1
TAT (minutes) 1440 420 15-120
Labour +1FTE
Batch Size 1 1 1-96
Understand company culture and existing systems
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Organizational Structure
MALDI Program
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Similar limitations as 16S rRNA Sequencing.
Scalability of support and capacity for North American market
Acetonitrile shortage 2008-2009
Mitigation plan
MALDI TOF Risk Management
Copyright Scott Adams
Decision making
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Don’t automate a process you don’t understand or control
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Heijunka - Level loaded work
Standardized work
A method to improve - Kaizen
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Load Replicator% Sat% Mon% Tues% Wed% Thurs% Fri%U/L Rep &Read% Sat% Mon% Tues% Wed% Thurs% Fri%Second Read% Fri% Sat% Mon% Tues% Wed% Thurs%NSG Worklist% Sat% Mon% Tues% Wed% Thurs% Fri%
U/L Inc & First Read% 1% 300% 750% 750% 700% 700% 700% 0%Load Replicator% 0.4% 120% 300% 300% 280% 280% 280% 0%U/L Rep &Read% 0.4% 0% 120% 300% 300% 280% 280% 280%Second Read% 0.4% 280% 120% 300% 300% 280% 280% 0%NSG Worklist% 1% 300% 750% 750% 700% 700% 700% 0%
Monday! 7! 8! 9! 10! 11! 12! 13! 14! 15! 16! 17! 18! Total%U/L Inc & First Read% 300% 72% 72% 72% 72% 56! 120! 192! 192! 848%Load Replicator% 120% 60% 60% 0% 0% 0% 120%U/L Rep &Read% 0% 0% 0% 0% 0% 0% 0%Second Read% 280% 60% 60% 60% 60% 40% 280%NSG Worklist% 300% 72% 72% 72% 72% 56% 120% 192% 192% 848%
Understand your processes
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Map the process
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In reality:
Plan Do………
Define Measure Analyze Improve Control
Plan Do Study Act
Initiate Plan Execute Monitor and Control Close out
Achieving Continuous Improvement
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PANIC!
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Vision and Strategy for Microbiology
QUESTIONS