Lean

Laboratory Medicine

Lean Six Sigma - the Industrial Approach to Quality also applicable to drive Quality in Healthcare

10-11February 2011 Labquality Days Helsinki

Tom M Pettersson. PhD [email protected]

Copyright Siemens Healthcare Diagnostics 2010. All rights reserved.

Lean is part of Industrial Quality Development

Benjamin Franklin Waste Nothing
1706 - 1790

Lean
Laboratory Medicine

Henry Ford Short and fast Process Waste Nothing

Frederick Taylor Scientific approach to work

Walter Shewart Statistics TQM

Joseph Juran Improvement through projects Pareto Principle

Edward Deming

The man who discovered Quality

The 7 Wastes (TPS QCDM)

Taiichi Ohno Toyoda
M Imai
Kaizen low Cost Continuous Improvement

Value Engineering

Lean
Lean
Manufacturing Services

Customer Focus

Larry Miles

Jim Womack (LEI)

John Seddon

Noriaki Kano

Six Sigma
(DMAIC)
Carl Friedrich Gau (1777- 1855)

QC Rules Lab Medicine

ISO CEN
Standardization ISO 9001/2008

Bill Smith
(Motorola)

Page 2

Dr Carl Henrik de Verdier Copyright Siemens Healthcare Diagnostics 2010. All rights reserved. Uppsala James Westgaard

ISO 17025 ISO 15189

Lean is part of Industrial Quality Development

Benjamin Franklin Waste Nothing
1706 - 1790

Lean
Laboratory Medicine

Henry Ford Short and fast Process Waste Nothing

Frederick Taylor Scientific approach to work

Walter Shewart Statistics TQM

Joseph Juran Improvement through projects Pareto Principle

Edward Deming

The man who discovered Quality

The 7 Wastes (TPS QCDM)

Taiichi Ohno Toyoda
M Imai
Kaizen low Cost Continuous Improvement

Value Engineering

Lean
Lean
Manufacturing Services

Customer Focus

System Thinking

No Waste in Process QCDM Value Larry Miles

Six Sigma
(DMAIC)

Jim Womack (LEI)

John Seddon

Noriaki Kano

Carl Friedrich Gau (1777- 1855)

Bill Smith
(Motorola)

Page 3

QC Rules Process/ ISO QMS Lab Medicine CEN Product Stability ISO 17025 ISO 15189 Dr Carl Henrik de Verdier No Errors Copyright Siemens Healthcare Diagnostics 2010. All rights reserved. Uppsala
Standardization ISO 9001/2008

James Westgaard

Two Ways of Thinking Two Ways of Management

Lean
Laboratory Medicine

Command and Control

Experts Lead
Weber Taylor Smith

Lean System Thinking

Deming Ohno Womack Seddon

Work

Decision
Imai

Work/Decision
Decision integrated with Work in Lean System approach

Decision separated from Work equal to Six Sigma approach

Page 4

Copyright Siemens Healthcare Diagnostics 2010. All rights reserved.

The TPS Approach

Lean
Laboratory Medicine

He called the Toyota system profit-making industrial engineering.

- in Lean all we do is to reduce the time it takes from when we commit money to the raw materials to when we collect money from our customers We design for best quality to lowest price We mobilize all intelligence in the organization to meet our purpose

Taiichi Ohno Father of the Toyota Production System

Copyright Siemens Healthcare Diagnostics 2010. All rights reserved.

Page 5

Lean Focus

Lean
Laboratory Medicine

Yet the most powerful aspect of LEAN is not what participants do to add to improve a process but what they remove from the process to improve it
Page 6 Copyright Siemens Healthcare Diagnostics 2010. All rights reserved.

Lean

Value added Activities of total Process LEAD time

Laboratory Medicine

Non Value Added Time

Value Added Time

Organizations adopting LEAN as a continuous improvement metodology typically find 95% of all process lead time is non value added
Page 7 Copyright Siemens Healthcare Diagnostics 2010. All rights reserved.

The 7 + 1 Wastes

Lean
Laboratory Medicine

Over production Not Right First Time Scrap, Rework, Devects

1 7 6 2 3

Inventory

8
Over processing Motion

Untapped Human Potential

5
Transportation

4
Waiting

Page 8

Copyright Siemens Healthcare Diagnostics 2010. All rights reserved.

Lean
Laboratory Medicine

Lean
Laboratory Medicine

Lean

The Process is the Problem - Not the People

Laboratory Medicine

Traditional Focus
1. Employees are the problem 2. Doing my job 3. Understanding my job 4. Measure individuals 5. Change the person 6. Can find a better employee 7. Motivate people 8. Control employees 9. Distrust 10. Who made the error 11. Correct errors 12. Bottom-line driven

Process Focus
1. Process is the problem 2. Helping to get things done 3. How my job fits in total process 4. Measure processes 5. Change the process 6. Can always improve the process 7. Remove barriers 8. Develop people 9. We are in it together 10. What allowed the error to occur 11. Reduce variation 12. Customer driven

Lean
Page 11 Copyright Siemens Healthcare Diagnostics 2010. All rights reserved.

Lean in Practice Brain is bigger than Tools

Team Based Communication

Lean
Laboratory Medicine

Communication

First Line Manager

Lean Leadership Vision Goals Strategy

The Information Highway Of The Organization Individuals Access to The Information Highway Non-Team Based Communication First Line Manager Communication

Lean Coach / Facilitator

Motivate and Empower

Staff understand Processes Continuously improve Deliver results

Awareness and Commitment

Selfsustainable Lean team

The Lean Team

Visualize processes Measure to prove value Short Gemba Meetings Kaizen Boards Track Ideas Choose Improvements Go and do it ! Lean Tools Metrics Value Stream Mapping 8 Wastes, 5S, 5 Why Kaizen Blizes (PDCA)

Behavior and Procedures

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Share Knowledge

Management by Science

Copyright Siemens Healthcare Diagnostics 2010. All rights reserved.

Lean Design and Management

Staff Participation Lean Transformation Lean Leadership Lean Culture Lean Teams Lean Micro/Macro Processes Lean A3-Learning Lean Tools Lean Metrics

Lean
Laboratory Medicine

Adopt IT fr Process Control Lean IT

Understand Present Process

Design of Future Process

Structured Implementation PDCA, DMAIC, DFSS

Page 13 Copyright Siemens Healthcare Diagnostics 2010. All rights reserved.

Create the right Value

Lean
Laboratory Medicine

Growth Competitiveness Cost efficiency Margin (Profit)

Best Quality

Business Value (Cost)

Customer Value (Delivery)

Lowest Price Shortest Delivery

Satisfaction Commitment Joy

Value For staff (Motivation)

Quality in Process (Quality)

No Waste No Error Simplicity

Page 14

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Lean is a Growth Strategy Sustainable Success Growth

Lean

Lean
Laboratory Medicine

Established Processes

Customer Satisfaction

Revenue / Margin

Increased Profitability More Customers Better Products More Efficient Processes Reduced Waste

Reduced Waste Headcount Reductions More Efficient Processes Motivation Better Customer Service Spare Capacity Headcount reduction

Yes !
Page 15

Lean

No !
Copyright Siemens Healthcare Diagnostics 2010. All rights reserved.

Lean Proven Success

Lean
Laboratory Medicine

Deming visits Taiichi Ohno

Japan electronics US Automotive

US electronics Japan automotive 1920 1940 1960 1980 2000 2010

Quality in Process Cost is lowest Delivery is best Motivated Staff

Page 16

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Lean Production - Build on Demand not for Stock

Mass Production ( variety is separated, many production lines, work force specialization)

Lean
Laboratory Medicine

Maximize Speed

Defect Repair Area

Build for Stock ( Make and sell Mass)

Defects or problems = Fix at the End of the Line = High Rework

Lean Production, Variety is integrated (one production line, one work force constructing all varieties

Build on Demand (Sense and Respond Lean)

Defects or problems = Stop the whole Line = No Rework
Page 17 Copyright Siemens Healthcare Diagnostics 2010. All rights reserved.

Lean Production - Build on Demand not for Stock

Mass Production ( variety is separated, many production lines, work force specialization)

Lean
Laboratory Medicine

Maximize Speed

Defect Repair Area

Build for Stock ( Make and sell Mass)

Defects or problems = Fix at the End of the Line = High Rework

Lean Production, Variety is integrated (one production line, one work force constructing all varieties

Build on Demand (Sense and Respond Lean)

Defects or problems = Stop the whole Line = No Rework
Page 18 Copyright Siemens Healthcare Diagnostics 2010. All rights reserved.

Lean Healthcare End to End Flow Design

Lean
Laboratory Medicine

Production Lines in Hospital

Elective Surgery (on demand ) Emergency Surgery High Care Medical Outpatients Obstetrics Low Care Medical

Line Managers

Page 19

Copyright Siemens Healthcare Diagnostics 2010. All rights reserved.

Lean Healthcare End to End Flow Design

Shared Departments (large no small dept)
Emergency Surgery Medical Obstetrics Pediatric Intensive Care Oncology Imaging

Lean
Laboratory Medicine

Labs

Production Lines in Hospital

Elective Surgery (on demand ) Emergency Surgery High Care Medical Outpatients Obstetrics Low Care Medical

Line Managers

Page 20

Copyright Siemens Healthcare Diagnostics 2010. All rights reserved.

Lean Healthcare Worldwide

Lean
Laboratory Medicine

http://maps.google.com/maps/ms?ie=UTF8&hl=en&msa= 0&msid=117519194103230134041.000470e737b7696a23930&ll =39.909736,-95.009766&spn=63.368016,112.5&z=3&source=embed

Capio StGran
2005 Learning Organization

Ryhov Jnkping
Microsystem Approach

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Capio StGran Individual Planning No Classical Rounds

Visualization and teamwork key parts of LEAN improvement
Example: Process work at cardiac ward - Overview of white-board
Personnel Room 17 19:1 Red Team 19:2 20:1 20:2 14 15 16 Blue Team 21:1 21:2 Beh rum IVA K.K-22 MIDA Patient P.O-66 GE-40 S.S-26 K.K-23 W.O-40 E.R-45 T.Y-29 U.I-34 A-kabel MIDA Leave at 13 Waiting dept. 37 Monitoring MIDA MIDA T-metri Leave at 11 Leave after breakfast Tests Trop-I 10 Individual round 11 10 Angio Planning Coordination

Time Thieves Capio StGran Radiology Laboratory Medicine IT

The Lean T Stream Model for Customer Value

Shared HC Functions IT Support process HIS/EMR/RaR

Lean
Laboratory Medicine

Patient flow

End to End Patient Value Stream

Service Processes Radiology Physiology Lab Medicine

IT Support processes RIS/PACS/LIS/Middlewares

Page 24

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Integration of Functions
RaR
HIS / EMR / PMS

Lean
Laboratory Medicine

Healthcare IT
Treat Patient

Patient Journey- Disease oriented Process- create Flow

Meet Dr POCT

CC / Ser / Imm

Phys

Rad

RIS / PACS

RRL

Trans Med Hem, Coag

C5LIMS

MW MW MW MW 1 2 3 4

Bact

Core
Page 25

Lab IT

Pathol Molec. Biol

Copyright Siemens Healthcare Diagnostics 2010. All rights reserved.

Integration of Functions
RaR
HIS / EMR / PMS

Lean
Laboratory Medicine

Healthcare IT
Treat Patient

Patient Journey- Disease oriented Process- create Flow

Meet Dr POCT

Improve Timing

CC / Ser / Imm

Phys

Rad

RIS / PACS

RRL

Trans Med Hem, Coag

C5LIMS

MW MW MW MW 1 2 3 4

Improve Timing

Bact

Core
Page 26

Lab IT

Pathol Molec. Biol

Copyright Siemens Healthcare Diagnostics 2010. All rights reserved.

Integration of Functions
RaR
HIS / EMR / PMS

Lean
Laboratory Medicine

Healthcare IT
Treat Patient

Patient Journey- Disease oriented Process- create Flow

Meet Dr POCT

Integrated Information Flow and Process Control

Improve Timing
CC / Ser / Imm

Phys

Rad

RIS / PACS

RRL

Trans Med Hem, Coag

C5LIMS

MW MW MW MW 1 2 3 4

Improve Timing

Bact

Core
Page 27

Lab IT

Pathol Molec. Biol

Copyright Siemens Healthcare Diagnostics 2010. All rights reserved.

Integration of Functions
RaR
HIS / EMR / PMS

Lean
Laboratory Medicine

Healthcare IT
Treat Patient

Patient Journey- Disease oriented Process- create Flow

Meet Dr POCT

Integrated Information Flow and Process Control

Improve Timing
CC / Ser / Imm

Phys

Rad

RIS / PACS

RRL

Trans Med Hem, Coag

C5LIMS

MW MW MW MW 1 2 3 4

Improve Timing

Bact

Core Network
Result Harmony
Page 28

Lab IT

Pathol Molec. Biol

Copyright Siemens Healthcare Diagnostics 2010. All rights reserved.

Integration of Functions
RaR
HIS / EMR / PMS

Lean
Laboratory Medicine

Healthcare IT
Treat Patient

Patient Journey- Disease oriented Process- create Flow

Meet Dr POCT

Integrated Information Flow and Process Control

Improve Timing
CC / Ser / Imm

Phys

Rad

RIS / PACS

RRL

Trans Med Hem, Coag

C5LIMS

MW MW MW MW 1 2 3 4

Improve Timing

Bact

Core Network
Result Harmony
Page 29

Lab IT
From Batch to Automated Lean Single Unit Processing

Pathol Molec. Biol

Copyright Siemens Healthcare Diagnostics 2010. All rights reserved.

Lean Innovation Big Leap (ref Unilabs Skaraborg)

Lean
Laboratory Medicine

Lean Process Automated Core Lab

EPR1 EPR2 HIS PMS

Healthcare Processes

Common Customer Service

LIS DELTRIX

SIEMENS /Thermo WorkCell

MW terfrslutning
Buffer Inmatningsmodul LSM IMMULITE 2000

Common Sample Reception

Parallel processes Hematology Coagulation Transfusion medicine

ADIVA CENTAUR XP

Maximizing Analytical Consolidation

Biochemistry Pharmacology (TDM) Drugs Of Abuse (DOA) Proteins Trad. Clin. Chem. Immunochemistry Allergy Infection Disease Serology Autoimmunity

ADIVA CENTAUR XP

Utmatningssmodul

Centrifug

Second Line Processes Third Line Processes

Centrifug

ADVIA 1800

ADVIA 1800 ARCHITECT

Avproppning Alikvotering & mrkning

First Line CC/Ser/Imm Automated Process

Lean Bacteriology

Lean Cellular Pathology

Lean Molecular Biology

Page 30 Copyright Siemens Healthcare Diagnostics 2010. All rights reserved.

Lean for QA/QC

Lean
Laboratory Medicine

Lean, Six Sigma Product Control

Establish TEa max/min Specs / Method - LSL/USL Consider Biological Variation, Medical Need Eliminate Bias for Result Harmony Perform Adequate Risk Analysis (FMEA) Revise QC Procedures in Production Consensus Reference Intervals (NORIP)
Bias
LSL USL

Correct Order

Correct Medical Decision

Cons. Ref Intervals

Correct Sample
Process Capability

T Target

Correct Delivery Post-, Post analysis

Sigma (TEa Bias) / CV

Pre-, Pre analysis

Page 31

Preanalysis, Analysis, Postanalysis

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Form Batch processing to Single Unit Processing

Lean
Laboratory Medicine

Lean Process Histopathology

E-Request

LIS (Discipline integrated) Middle Ware for Lean Process Control

E-Report

Man WS
Accessioning data + Sample Grosssing/Orientation Tissue Processing

Man WS
Stainings Embedding Cutting Histochemistry IHC ISH Special

Man WS
Interpretation Microscopy Imaging

Arch

Old Process VAT < 2%, High Risk for Errors Work Cell Automation Design for Single Unit Flow Goal 80 % delivery within same day

LEAN WS A
Automation No Connectivity

LEAN WS B
Automation No Connectivity

LEAN WS C
Automation Connectivity

LEAN WS D
Automation Connectivity

Reorganize staff

Paperless

Production

Page 32

Copyright Siemens Healthcare Diagnostics 2010. All rights reserved.

Form Batch processing to Single Unit Processing

Lean
Laboratory Medicine

Lean Process Bacteriology

Order in

LIS DELTRIX (Common for CC/Ser/Imm/Bact/Path)

Report out

Middle Ware (Steering Automation, Data Concentrator - Images, MALDI TOF and AST data)
Primary Sample:
Liquid

Fast
Pick out Negatives
Flowcytometry

tracks

Work Cell Automation Design for Single Unit Flow New Technology (MALDI ToF) disrupts old Process Potential within Day Reporting

Secondary Samples:
Plates Tubes Slides

Antigen Tests

Molecular Direct Biology direct Identification Hybridization on MALDI PCR-Semi /Full Automation TOF MS Random

Identify
Biochemistry

Cultivation
Unique Labeling
Plate, Tubes From Store
Direct appl.

Inoculate - Antibiotic Streak out Discs for AST

Incubate

Interpret Image orig. Image AST

Identify
MALDI TOF MS

Colony

Incubate and Evaluate AST

Auto-Work Cell I

Auto-Work Cell II

Auto-Work Cell III

Paperless Production
Page 33 Copyright Siemens Healthcare Diagnostics 2010. All rights reserved.

Designing the Integrated Lean Laboratory

Lean
Laboratory Medicine

Staff design Processes

Molecular Biology Process Histopathology / Cytology Process Bacteriology process Parallell Processes Primary Automation Process Secundary Processes Tertiary Processes Send outs
Harmonized Value Streams Design Single Unit Processing

Nucleic acids Tissues Cultivations Biological Liquids

Patient Flow
POCT

Integrated Information

Process Control

Integrated Sample Flow

Lean IT

Staff continuously improve Processes IVD Industry listens to the Customer for Innovation
Page 34 Copyright Siemens Healthcare Diagnostics 2010. All rights reserved.

Lean System Thinking

Lean
Laboratory Medicine

Lean is Culture
Continuous Improvement /Innovation Respect for People Focus on Processes Clarity on Purpose

Page 35

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Rational and Creative Select Improvements

Lean
Laboratory Medicine

Doing new things Vital Few Imagination Inspiration Intuition

Learn by doing

Closing Gaps Working together

Page 36 Copyright Siemens Healthcare Diagnostics 2010. All rights reserved.

QMS hampers Continuous Improvement

Facts drive development
MEASURE
ACT PLAN

Lean
Laboratory Medicine

ISO
9000/17025/15189
Quality Management System (QMS)

Customer Pull Patient User Payer LEAN / SixSigma

Does not promote a culture of Continuous Quality Improvement (CQI)

DEFINE

CHECK DO

ACT

ANALYZE
PLAN

ACT

CHECK DO

CHECK DO

PLAN

IMPROVE

CONTROL

S QM

Business and Process Challenges

Page 37 Copyright Siemens Healthcare Diagnostics 2010. All rights reserved.

QMS must support Continuous Improvement

Facts drive development
MEASURE
ACT PLAN ACT DO ACT CHECK DO CHECK DO PLAN PLAN

Lean
Laboratory Medicine

ISO
9001/17025/15189
Quality Management System (QMS)

Customer Pull Patient User Payer

Lean SixSigma
Stabilizes and puts Focus on Improvements

+ CQI

DEFINE

CHECK

ANALYZE IMPROVE

CONTROL

S QM

MS Q

Business and Process Challenges

Copyright Siemens Healthcare Diagnostics 2010. All rights reserved.

Page 38

Customer pulls the Value Organization delivers

Lean
Laboratory Medicine

Continuously Improve, Innovate, Change for Value

Lean Value Dimensions Customer Value Patient / User / Payer Medical Excellence Patient Safety Correct Fast / Timely Coordinated Reproducible Operational Excellence
Delivery Window 30 min to 24 hours (80-90%)

Lean

Six Sigma,

ISO 15189

Quality in Process Cost is lowest Delivery is best Motivated Staff

Page 39

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Lean

Manage the Healthcare Dilemma

Laboratory Medicine

Meeting increasing Demand and Limitation in Resources with Lean Value Stream Design
Non Value Added Time

Value Added Time

Page 40

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It is About People
There is No Such Thing as Operator Error
Lean
Laboratory Medicine

It is PROCESSES not PEOPLE that Fail. This maps to one of Demings 14 Points for Management: DRIVE OUT FEAR. Focus on Processes implies that people are not accused, but rather, that they are able to investigate processes and be part of the solution.
http://www.1000advices.com/guru/quality_tqm_14points_deming.html

Page 41

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