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1 Product Presentations and Corporate Perspectives on Automated Histology Systems: Leica Microsystems Inc. Presented by Katja Lehmann and Jan Minshew 4/30/09 Living up to Life © Katja Lehmann / Jan Minshew, Leica Microsystems, 2009 Topics Current Challenges Into the future – Laboratory vision From Patient to Pathologist – Capabilities of future automated products Lean Histology – State of the Art Laboratory Get started with Lean in your Laboratory

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Page 1: Leica Microsystems Inc. - Executive War College...Poka Yoke (Error-proofing) through barcoding and pre-defined panels More consistent results through automation (staining, etc.) x

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Product Presentations and Corporate Perspectiveson Automated Histology Systems:

Leica Microsystems Inc.

Presented byKatja Lehmann and Jan Minshew

4/30/09

Living up to Life

© Katja Lehmann / Jan Minshew, Leica Microsystems, 2009

TopicsCurrent Challenges Into the future – Laboratory visionFrom Patient to Pathologist – Capabilities of future automated productsLean Histology – State of the Art LaboratoryGet started with Lean in your Laboratory

Page 2: Leica Microsystems Inc. - Executive War College...Poka Yoke (Error-proofing) through barcoding and pre-defined panels More consistent results through automation (staining, etc.) x

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Living up to Life

© Katja Lehmann / Jan Minshew, Leica Microsystems, 2009

Current Challenges in HistologyASCP 2008 Wage and Vacancy Survey– Average Vacancy Rates

• HT – 8% (medium volume labs – 33.8%)• HTL – 7.2%• HT Supervisor – 4.1%

– Average time to fill positions • HT in medium volume labs – 3 to 6 months• HT Supervisor – 6 to 12 months

– Increase in turnover from 2005• HT medium volume labs – 28%• HT high volume labs – 32%• HTL high volume labs – 31%

Living up to Life

© Katja Lehmann / Jan Minshew, Leica Microsystems, 2009

Into the future – Laboratory VisionPaperless Lab– Barcode scanning for positive patient ID, specimen tracking, workload

recording, archiving and retrieval – Voice recognition software and digital images for grossing

Automated Workstations– Combined automated equipment

Page 3: Leica Microsystems Inc. - Executive War College...Poka Yoke (Error-proofing) through barcoding and pre-defined panels More consistent results through automation (staining, etc.) x

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Living up to Life

© Katja Lehmann / Jan Minshew, Leica Microsystems, 2009

Automation – Why?Automation should always be used to replace manual tasks that require standardization (processing and staining) or contribute to MSD (slide and cassette labeling, microtomy and coverslipping)How do you determine the proper balance– Automated instruments

• Reduces physical stresses on operators• Replaces manual tasks that contribute to MSD• Provide standardization and consistency

– People• Provide human interaction (mechanical failures, etc)• Use decision making based on visual interpretation and cognitive

experience

Living up to Life

© Katja Lehmann / Jan Minshew, Leica Microsystems, 2009

From Patient to PathologistAccessioning – Gross Room

Page 4: Leica Microsystems Inc. - Executive War College...Poka Yoke (Error-proofing) through barcoding and pre-defined panels More consistent results through automation (staining, etc.) x

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Living up to Life

© Katja Lehmann / Jan Minshew, Leica Microsystems, 2009

Accessioning - Gross RoomAccessioning

Requisition forms with barcodes to link with LIS or stand-alone systemBarcode labels for specimen containersPredetermined panels for determining quantity of cassettes and slides by specimen type (with flexibility to accommodate exceptions)Barcode and human readable printing of cassette labels

GrossingTemplates for standard gross descriptionsVoice recognition software for report generationPaperless Notes for downstream workstationDigital photography to integrate into reports

Living up to Life

© Katja Lehmann / Jan Minshew, Leica Microsystems, 2009

From Patient to PathologistProcessing

Page 5: Leica Microsystems Inc. - Executive War College...Poka Yoke (Error-proofing) through barcoding and pre-defined panels More consistent results through automation (staining, etc.) x

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Living up to Life

© Katja Lehmann / Jan Minshew, Leica Microsystems, 2009

Processing

Rapid ProcessingContinuous processing for smooth workflowCassettes scanned to record which processor and program was usedReduced turn around time (TAT) from small biopsies to large fatty breastFaster results reporting without compromising quality Reduction in reagent costs with advanced reagent management system Reduced waste with xylene-free processing

Living up to Life

© Katja Lehmann / Jan Minshew, Leica Microsystems, 2009

From Patient to PathologistEmbedding

Page 6: Leica Microsystems Inc. - Executive War College...Poka Yoke (Error-proofing) through barcoding and pre-defined panels More consistent results through automation (staining, etc.) x

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Living up to Life

© Katja Lehmann / Jan Minshew, Leica Microsystems, 2009

Embedding

EmbeddingBlocks are scanned to indicate operator and time in time out for workload

recordingNotes are readily available on a LCD screen for embedding and special

handling instructions Specimens are manually or automatically embedded (depending on

available technology)

Living up to Life

© Katja Lehmann / Jan Minshew, Leica Microsystems, 2009

From Patient to PathologistSectioning

Page 7: Leica Microsystems Inc. - Executive War College...Poka Yoke (Error-proofing) through barcoding and pre-defined panels More consistent results through automation (staining, etc.) x

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Living up to Life

© Katja Lehmann / Jan Minshew, Leica Microsystems, 2009

Slide LabelingLabeling at the microtomy workstation

Barcode on cassette is scanned and slides are printed from user pre-defined slide typesSlides match only the block being sectioned (error reduction)Printing barcode labeled slides from panels will designate which automated stainer will be used

Living up to Life

© Katja Lehmann / Jan Minshew, Leica Microsystems, 2009

Microtomy

Automated MicrotomyBlocks are scanned to indicate operator and time in-time out for workload recordingNotes are readily available on a LCD screen for sectioning and special handling instructions Sectioning is consistent because of precise specimen advance and motorized cutting strokeRepetitive motions are reduced that can contribute to musculoskeletal disorders

Page 8: Leica Microsystems Inc. - Executive War College...Poka Yoke (Error-proofing) through barcoding and pre-defined panels More consistent results through automation (staining, etc.) x

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Living up to Life

© Katja Lehmann / Jan Minshew, Leica Microsystems, 2009

From Patient to Pathologist

Staining - Coverslipping

Living up to Life

© Katja Lehmann / Jan Minshew, Leica Microsystems, 2009

Staining and CoverslippingStainer/Coverslipper Workstation

Integration greatly reduces operator interface Ovens incorporated into the instrument to dry slidesContinuous rack loading and unloading systemCoded racks to inform instrument which stain program to useReagent Management System to display reagent exchange cycleRoutine and Special Stains on the same instrument, if desired

Page 9: Leica Microsystems Inc. - Executive War College...Poka Yoke (Error-proofing) through barcoding and pre-defined panels More consistent results through automation (staining, etc.) x

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Living up to Life

© Katja Lehmann / Jan Minshew, Leica Microsystems, 2009

From Patient to Pathologist

Immunohistochemistry

Living up to Life

© Katja Lehmann / Jan Minshew, Leica Microsystems, 2009

IHC / ISH

Immuno StainingIntegration with LIS for workload recording and real time trackingBarcoded slide labels specify staining procedureContinuous loadingSimplified set up with ready-to-use antibodies (no mixing, titration or dilution) or use your own dilutions

Page 10: Leica Microsystems Inc. - Executive War College...Poka Yoke (Error-proofing) through barcoding and pre-defined panels More consistent results through automation (staining, etc.) x

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Living up to Life

© Katja Lehmann / Jan Minshew, Leica Microsystems, 2009

From Patient to Pathologist

Case check out for delivery to Pathologist

Living up to Life

© Katja Lehmann / Jan Minshew, Leica Microsystems, 2009

Case Check OutConsolidating, matching blocks and slides, checking paper trails,

determining who gets what, recording what’s still missing…What a mess!!!There must be a better way, right? We think so!– Scanning barcodes on slides to assist with consolidation, record

completion and time-out – Determine and record distribution path– Scan blocks for archiving location– Scan slides to record return and location for archiving– Scan blocks and/or slides for repeat check-out and determine

location

Page 11: Leica Microsystems Inc. - Executive War College...Poka Yoke (Error-proofing) through barcoding and pre-defined panels More consistent results through automation (staining, etc.) x

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Living up to Life

© Katja Lehmann / Jan Minshew, Leica Microsystems, 2009

The end for Jan

Living up to Life

© Katja Lehmann / Jan Minshew, Leica Microsystems, 2009

Lean Histology - What are we striving for?Create a “State of the Art” Laboratory

Best Combination of People, Processes, Products and PerformanceAllow for Growth

Page 12: Leica Microsystems Inc. - Executive War College...Poka Yoke (Error-proofing) through barcoding and pre-defined panels More consistent results through automation (staining, etc.) x

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Living up to Life

© Katja Lehmann / Jan Minshew, Leica Microsystems, 2009

Lean Histology – State of the Art Laboratory

Decrease Defects – Increase QualityPoka Yoke (Error-proofing) through barcoding and pre-defined panelsMore consistent results through automation (staining, etc.)

x

Quality Defects

Slide or cassette

labeling errors1,2,3,4,5,6

Overproduction

Printing too

many cassettes

or hold slides

Living up to Life

© Katja Lehmann / Jan Minshew, Leica Microsystems, 2009

Lean Histology – State of the Art LaboratoryContinuous Workflow

Know your customer demand (Takt Time) and your process capabilities (Cycle Time) and refine workflow to meet demand

- Implement “One Case Flow” – smaller batches- Eliminate Muda (waste)- Adjust staffing schedules and incentives- Implement Inventory Management System (kanban)- Implement Visual Management Tools to Monitor Daily

Productivity

Cycle Time TAKT Time

What we can

do

What we can

do

What we need to do

What we need to do

De-Burring

ProcessScraping Wax

Page 13: Leica Microsystems Inc. - Executive War College...Poka Yoke (Error-proofing) through barcoding and pre-defined panels More consistent results through automation (staining, etc.) x

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Living up to Life

© Katja Lehmann / Jan Minshew, Leica Microsystems, 2009

Continuous Flow - Rapid Processing

Living up to Life

© Katja Lehmann / Jan Minshew, Leica Microsystems, 2009

Improved Processing and Staffing Schedule AM PM

TimeTRANSCRIPTIONACCESSION ROOMGROSS ROOMHISTOLOGYHISTOLOGYHISTOLOGY

AM PM

TimeACCESSION ROOMSmall Blocks (GI)Routine BlocksTRANSCRIPTION

AM PM

Time

Peloris Retort 1

Peloris Retort 2

BLOCKS TO EMBED

CUTTING

OVEN DRY 15 20 10 30

H&E STAIN

COVERSLIP, LABEL, MATCH PAPERWORK, DELIVER

15 20 10 30

10 GI's

15

4:00

5:00

15

Resident

Histo Tec

1515

4:00

5:00

8:00

9:00

10:00

11:00

15 1020 30

15 1010

STAFFING and Processing SCHEDULE

12:00

1:00

8:00

9:00

10:00

11:00

6:00

7:00

12:00

1:00

2:00

3:00

8:00

9:00

10:00

11:00

AM

12:00

1:00

2:00

3:00

4:00

5:00

6:00

7:00

25TOTAL

15 Routines - delayed start overnight

PROCESSING TIMES

15 GI's

TOTAL 25

12:00

1:00

8:00

9:00

10:00

11:00

6:00

7:00

12:00

1:00

2:00

3:00

4:00

5:00

6:00

7:00

12:00

1:00

2:00

3:00

12:00

1:00

8:00

9:00

10:00

11:00

7:00

12:00

1:00

2:00

3:00

9:00

10:00

11:00

6:00

4:00

5:00

5:00

6:00

7:00

8:00

12:00

1:00

2:00

AM

3:00

4:00

Medical SecretaryMedical Secretary

CASSETTES GROSSED BY HOUR - BY SIZEAM

Histology Supervisor

Histo Tec

1010

xx

10 Routine'sdelayed overnight

15 1010

Laboratory improved TAT from 3 days to 1.2 days

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Living up to Life

© Katja Lehmann / Jan Minshew, Leica Microsystems, 2009

Lean Histology – State of the Art Laboratory

Faster Turn Around TimeEliminate multiple data entry pointsEliminate paper-trailsReduce number of hand-offsFaster processing time

ZZZZ

ZZZ

Waiting

Overnight

processor runRUSH!

Water Spider

Transportation

Paperwork Trail

Living up to Life

© Katja Lehmann / Jan Minshew, Leica Microsystems, 2009

Lean Histology – State of the Art LaboratoryMinimize Costs

Inventory Management System (Kanban, FIFO) to manage replenishment cycles and reduce disposal of expired consumables.Decrease consumable costs through Reagent Management SystemsEliminate cost of buying and disposing of hazardous waste (xylene free)Use consumables appropriate for the procedure and instrument

- Biopsy cassettes eliminate the carry over from sponges- Active Flow cassettes for better fluid exchange

Inventory

Expired

Reagents

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Living up to Life

© Katja Lehmann / Jan Minshew, Leica Microsystems, 2009

Lean Histology – State of the Art Laboratory

Safer Work EnvironmentDecrease repetitive motion stepsDecrease exposure to hazardous chemicals (xylene-free work)Less stressful work environment will reduce errors and accidents

Motion

Repetitive Motion

at Sectioning

Staining and Coverslipping

Stations

Living up to Life

© Katja Lehmann / Jan Minshew, Leica Microsystems, 2009

Get started with Lean

Set your organization up for successleadership buy-in / championship and cultural

change are key for sustainability and employee buy-inLook at 20,000ft picture as everything you touch upstream will

affect downstream processesColor codingSpecimen sorting (size, type, etc.)Processing times

Automation is able to change workflow if used to its capabilitiesPurchasing the instrument doesn’t change anything yetRevisit your lab layouts if you bring in new instrumentationRevisit how the instrument impacts your cycle time and adjust staffing

1st

Unused Creativity

Page 16: Leica Microsystems Inc. - Executive War College...Poka Yoke (Error-proofing) through barcoding and pre-defined panels More consistent results through automation (staining, etc.) x

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QUESTIONS ?