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Exploring the Medical Laboratory Quality ToolBox-B. Michael A Noble MD FRCPC Clinical Microbiology Proficiency Testing program Program Office for Laboratory Quality Management University of British Columbia Vancouver BC. The Quality Toolbox. Lean. Surveys. Six Sigma. RISK FMEA. Metrics.

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exploring the medical laboratory quality toolbox b

Exploring the Medical Laboratory Quality ToolBox-B

Michael A Noble MD FRCPC

Clinical Microbiology Proficiency Testing program

Program Office for Laboratory Quality Management

University of British Columbia

Vancouver BC

the quality toolbox
The Quality Toolbox

Lean

Surveys

Six Sigma

RISK

FMEA

Metrics

Statistics

The Quality Toolbox

The Quality Toolbox

what are quality tools
What are quality tools?

LEAN

Six Sigma

ISO 9001: 2000

A quality tool is a supplement or component part of a quality program that usually will not stand alone but can enhance the total quality system

January 2009

3

tools in the toolbox
Mega-Tools

Lean

Six Sigma

Priority Matrices and Risk Assessment

Tools/Techniques

Balanced Scorecards

Brainstorming

Control Charting

Flow Charting

Quality Indicators

Surveys

Tools in the Toolbox
historical references to lean
Historical References to LEAN

VenetianShip Building

Industry

1988

BenjaminFranklin

Inventorywaste

Deming

1915

Henry Ford

1950

ToyotaTaiichi Ohno

HealthCare2000

Juran

EliWhitneyreplacement parts

FrankGilbrethmotion studies

henry ford
Model T

1908-1915

The automotive assembly line

7 years in development.

A “slaughterhouse in reverse”.

Mass production by moving the product to the worker.

Faster

12.5 to 1.5 worker hours/car

Safer

Workers not roaming with tools

Cheaper

Reduced unit pricing for cars

Worker benefit

Highly paid salaries to workers

Unintended consequences both positive and negative shaped and reshaped the world.

Henry Ford
taiichi ohno
Taiichi Ohno
  • Toyota Production System
    • American Influences
      • Ford Motor Company
        • Excessive inventory
        • Workload was excessive and uneven
      • Piggly Wiggly Foods
        • Reordering and restocking inventory when needed
        • Just in Time ordering.
  • TPS is designed to
    • remove overburden (muri) and inconsistency (mura), and eliminate waste (muda).
tps philosophy
TPS Philosophy
  • The right process will produce the right results
  • Create continuous process flow to bring problems to the surface.
  • Use the "pull" system to avoid overproduction.
  • Level out the workload. (Work like the tortoise, not the hare.)
  • Build a culture of stopping to fix problems, to get quality right the first time.
  • Standardized tasks are the foundation for continuous improvement and employee empowerment.
  • Use visual control so no problems are hidden.
  • Use only reliable, thoroughly tested technology that serves your people and processes.
  • Add value to the organization by developing your people and partners
  • Grow leaders who thoroughly understand the work, live the philosophy, and teach it to others.
  • Develop exceptional people and teams who follow your company's philosophy.
  • Respect your extended network of partners and suppliers by challenging them and helping them improve.
  • Continuously solving root problems drives organizational learning
  • Go and see for yourself to thoroughly understand the situation Make decisions slowly by consensus, thoroughly considering all options; implement decisions rapidly;
  • Become a learning organization through relentless reflection and continuous improvement.
value streams
Value Streams

Activity transforms - waiting is waste

Activity flows through pools of waste

Customers value active transformation and abhor waste

value streaming identifying process waste
Value streaming:IDENTIFYING PROCESS WASTE

INVENTORY

PROCESS

MONITORING

AVAILABILITY

ORDER

DELIVER

COLLECTION

ACCESS

AVAILABILITY

COMPETANCY

CHECKINGPROCESS

VERIFICATION

VALIDATION

TESTING

PROCESS

PERSONNEL

EQUIPMENT

WORKSPACE

ENVIROMENT

TRANSPORT

ACCESS

AVAILABILITY

ACTIVITY

ACCURACY

INTERPRETATIONPROCESS

CLINICALRELEVANCY

process mapping pre examination procedures
Process MappingPre-Examination Procedures

Phlebotomists

Accessioning

Physician

Phlebotomist leaves

Phlebotomist goes to ward

Check room

Find patient

Check armband

Check order

Check requisition

Check tubes

Draw blood

Check tubes

Sign off requisition

Time punch requisition

Package Tubes

Transport tubes

Sample checked in

Requisition time punched

Sample unpackaged

Tubes confirmed

Tube numbers created

Tubes number labeled

Tube tops removed

Centrifugation

Aliquoting

See patient

Go to station

Find chart

Find order page

Write order

Flag chart

Put in right pile

Check order

Transcribe order

Contact lab

identifying waste in laboratory testing
IDENTIFYING WASTE INLABORATORY TESTING
  • WAITING for a test order
  • WAITING for a requisition
  • WAITING to collect a sample
  • WAITING to transport a sample
  • WAITING to accession a sample
  • WAITING to start processing a sample
  • MOVING to collect reagents at a distant location
  • MOVINGfrom one work station to anther
  • SEARCHING for an instrument or material essential for processing a sample
  • WAITING to complete processing a sample
  • WAITING to create a report
  • CREATING an excessive report
  • CREATING an non-interpretable report
  • WAITING to transport a report
  • WAITING for a report to be read
  • WAITING for report-generated action
  • WAITING to contact a report recipient
reducing waste in the medical laboratory
Reducing WASTE in the Medical Laboratory
  • At-source Order Entry
  • No-wait transport
  • Condensed workspace
  • Structured workspace
  • Continuous flow processing
  • Automated Reporting
  • Auto-released reporting
  • Auto-interpreted reporting
reducing waste in the medical laboratory15
Reducing WASTE in the Medical Laboratory
  • At-source Order Entry
  • No-wait transport
  • Condensed workspace
  • Structured workspace
  • Continuous flow processing
  • Automated Reporting
  • Auto-released reporting
  • Auto-interpreted reporting
reducing waste in the medical laboratory16
Faster data entry

Faster transport

Reduced motion

Faster report release

Less tech time

More entry error

More transport cost

More inflexibility

Less personal report

More I.T. time

Reducing WASTE in the Medical Laboratory
lean s kanban trigger system
LEAN’s Kanban trigger system
  • A notification system that once activated triggers a response to start another process going.
  • “Think about inventory notification cards”
    • If you can see this card, you are soon to run out of materials. Time to order more.
poka yoke error proofing
Poka Yoke:Error Proofing
  • Placing workable limits that prevent an action from going wrong.
  • In mechanical systems, it means adding design features that allow two units to only work in one position.
  • An example is ECG testing

SD

ecg poka yoke
ECG Poka Yoke

R Arm

L. Arm

Foot

Chest

Limb Lead Reversal

poka yoke reduces ecg errors
POKA YOKE reduces ECG Errors

RED RIBBON

RIGHT SIDE

RIGHT ARM

RIGHT WAY

R Arm

L. Arm

Foot

Chest

identifying process waste
IDENTIFYING PROCESS WASTE

Pokayoke

INVENTORY

PROCESS

MONITORING

AVAILABILITY

ORDER

DELIVER

COLLECTION

ACCESS

AVAILABILITY

COMPETANCY

CHECKINGPROCESS

VERIFICATION

VALIDATION

Kanban

TESTING

PROCESS

PERSONNEL

EQUIPMENT

WORKSPACE

ENVIROMENT

TRANSPORT

ACCESS

AVAILABILITY

ACTIVITY

ACCURACY

INTERPRETATIONPROCESS

CLINICALRELEVANCY

5S

when pretty good is not good enough
When pretty good is not good enough
  • In 1980 Canada Post did a study which demonstrated that 98 per cent of business mail was delivered on time
  • The conclusion was the Canada Post was working well.

But…

with 2 percent late mail
With 2 percent late mail…
  • Canada Post delivered 50 Million pieces of business mail daily.
  • Which meant another 1 million pieces of business mail were delivered late.
  • And each year 260 million pieces of business mail were delivered late.
  • With 10 million business mail receivers, each mail receiver could expect at least 2 late business mail deliveries every month.
opportunity of improvement for canada post
Opportunity of Improvement for Canada Post
  • Implement a quality management system
  • Investigate why so many letters were being delivered late
  • Implement a plan to improve letter delivery
  • Develop a process for continual improvement
what is the performance on a test
What is the Performance on a Test?

Sensitivity: 98 percent Specificity: 99 percent

Prevalence in the Community of 100,000 people 0.1 per cent

Of 3056 positive tests, 2985 (99.3%) will be FALSE positives

Community of 100,000 with 10 per cent prevalence

Of 10,790 positive tests

990 (9.2%) will be FALSE positive

a march through quality history
A March through Quality History

BSI

ISO

ISO 9000

ISO 17025

ISO 15189

NATO

CDC

CLSI

WHO

ABCA

US Military

THE

WORLD

Deming

Shewhart

a march through quality history29
A March through Quality History

BSI

ISO

ISO 9000

ISO 17025

ISO 15189

NATO

CDC

CLSI

WHO

ABCA

US Military

THE

WORLD

Deming

Shewhart

galvin manufacturing to motorola
Galvin Manufacturing to Motorola

Cellular

Telephones

Computer

Parts

Television

Radio

Battery

Eliminator

galvin manufacturing to motorola31
Galvin Manufacturing to Motorola

1986

Six Sigma

Continual Improvement

Cellular

Telephones

Computer

Parts

Television

Radio

Battery

Eliminator

galvin manufacturing to motorola32
Galvin Manufacturing to Motorola

Bill Smith – Senior Quality Assurance

Robert Galvin - CEO

1986

Six Sigma

Continual Improvement

Cellular

Telephones

Computer

Parts

Television

Radio

Battery

Eliminator

slide33

Deming visits

Japan

electronics

US Automotive

US

electronics

Motorola

Digital

Japan automotive

1920 1940 1960 1980 2000 2010

  • In the U.S. industry did not want to listen
  • But Japan did.
six sigma cycle of improvement
Six Sigma Cycle of Improvement
  • DMAIC
  • Define process improvement goals that are consistent with customer demands and the enterprise strategy.
  • Measurekey aspects of the current process and collect relevant data.
  • Analyze the data to verify cause-and-effect relationships. Determine what the relationships are, and attempt to ensure that all factors have been considered.
  • Improve or optimize the process based upon data analysis using techniques like Design of experiments.
  • Control to ensure that any deviations from target are corrected before they result in defects. Set up pilot runs to establish process capability, move on to production, set up control mechanisms and continuously monitor the process.
who makes a green belt a green belt
Who Makes a Green Belt a Green Belt?
  • The Company
  • The Company can hire a Six Sigma company
  • In industry Sigma Belts have:
    • Cachet
    • Credibility
    • Ties to income
what is improvement
What is improvement
  • As DPMO goes down, Sigma goes up
  • Operational goals should apply
    • What is desirable?
    • What is achievable?
    • What is affordable?
  • A 1.5 short term Sigma Shift approximates an achievable long term expectation.
what does six sigma contribute
What Does Six Sigma Contribute?
  • A reiteration of Shewhart and Deming for project oriented continual Improvement.
  • A structured method for continual improvement.
  • A structured mathematical model for enumerating error and improvement.
and in summary
And in summary…
  • Quality Management is an active process.
  • Quality Management is framed on a Quality System.
  • Quality Management activities are improved by using the Quality ToolBox.

Lean

Surveys

Six Sigma

RISK

FMEA

Metrics

Statistics

The Quality Toolbox

The Quality Toolbox