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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