OPTIMIZING THE CORE

LABORATORY

ABBOTT DIAGNOSTIC
DIVISION (ADD)
Yogaswara Adiputro | IACC Sales Specialist
Feb|2018

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Agenda

Concept of Sig Sigma &

Sigma Metric

Application of Sigma Metric

in Medical Laboratory

Sigma Metric for Abbott

Platform

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What is Sig Sigma Quality Management System CHALLENGES

(QMS)

In Business world:

Six Sigma is a management

strategy that seeks to improve
the quality of process outputs
by identifying and removing
the causes of defects (errors)
and minimizing variability in
manufacturing and business
processes.

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 CHALLENGES

Six Sigma also referred to the ability of manufacturing processes to

produce a very high proportion of output within specification.

Processes that operate with "six sigma quality" over the short term
are assumed to produce long-term defect levels below 3.4
defects/errors per million opportunities (DPMO).

Six Sigma Capability:

Defect per
Million
σ Capability Yield (No Defect)
Opportunity
(DPMO)
2 308,537 69,1%
3 66,807 93,3%
4 6,210 99,4%
5 233 99,97%
6 3,4 99,99966%
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Medical Errors CHALLENGES

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Healthcare Focus is on management of errors CHALLENGES

and risk throughout the sample flow

PRE-ANALYTICAL ANALYTICAL POST-ANALYTICAL

62% 15% 23%

of all sources of of laboratory errors come of all sources of
laboratory errors from analytical causes laboratory errors
Sample Testing Reporting of results
Collection/
Identification

SOLUTIONS THAT DELIVER

HIGH QUALITY PATIENT OUTCOMES!
Reference: Carraro et al., Errors in a Stat Lab, Clin Chem. 2007; 53:7
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How does Six Sigma fit into Healthcare TQM CHALLENGES

In healthcare, “quality” has been difficult to define

“Performance” is a measure how well we are doing
“Quality” is a measure of performance against standard

How do we measure errors objectively in the lab?

- Errors counted and reported as number or %
- Performance are evaluated IQC and EQA via precision and bias
- In instances where there are questions about laboratory performance,
there are no clear scaling data to present
- This scaling data has to be an evidence-based analytical quality
specifications.

To measure errors objectively, Six Sigma provides principle and

methodology that can be widely applied to all laboratory processes.

Sigma-metrics are the key to making the quality measurable and

understandable.

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Six sigma concept in Healthcare TQM CHALLENGES

Six sigma improves the entire quality management process:

- Requires “tolerance limit” be defined to describe good quality and poor
quality/defect;
- Provides a standard scale –Sigma scale- measuring the quality of any
process;
- Identify the goal for how good quality should be, 6 sigma = world class.

Sigma metrics has been used to monitor performance of analytical system

by identifying biased and/or imprecision and Tea and translated into
Sigma Value which serve as benchmarking for performance.

Sigma value indicates how often defects are likely to occur

The higher the sigma value –less likely the process will generate defect

σ1 σ2 σ3 σ4 σ5 σ6
Non-Competitive Industry Average Industry Average High Quality World Class World Class
691,462 dpm 308,538 dpm 66,807 dpm 6210 dpm 233 dpm 3,4 dpm

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Applying sigma concepts to Clinical SOLUTION

Laboratory data
1) Define acceptability criteria: Total allowable error
(TEa);
2) For quantitative assays
• Determine imprecision
• Determine bias
3) Determine Sigma value:
Sigma = (TEa-bias)/CV

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Strategies for Selecting Total Error SOLUTION

Allowable (TEa)

Rank Strategy Sub-clasess

1 Impact on specific clinical decision Quality specification in specific
making clinical situation
2 Impact on general clinical decision 1. Based on Biological Variation
making 2. Based on medical opinion
3 Professional Recommendation 1. International expert groups
2. Expert Individual
4 EQAS Recommendation 1. Regulations
2. EQAS
5 Published data on state of the art 1. Published by PT/EQAS
2. Published individual method
Source: Stockholm consensus

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Types of TEa as a
Quality Requirements

- PT/External Quality Control

groups
- CLIA
- RCPA
- Rilibak
- Biological Variation Database
(Ricos Goals).

Where to find?
Westgard website

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 SOLUTION

Display of Sigma
Metrics

Normalized method
decision chart of Prodia
Lab, Indonesia
Source: https://www.westgard.com/sigma-vp-
prodia.htm

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 SOLUTION
Optimizing QC Design for Laboratory

Source: Six-Sigma Based Quality Control, Westgard (2016)

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Delivering confidence through KNOW

Six Sigma quality

ARCHITECT has greater Six Sigma performance for clinical chemistry
assays at 5 or 6 sigma (excellent or good)

LABORATORY STATISTICS

Hospital
Valley Health System
Winchester, VA

Size
6 hospitals, 594 licensed inpatient beds,
166 long-term care beds

Test Volume
 2.25 to 2.5 million tests
“We don’t have to troubleshoot as much and have fewer QC issues, so we (chemistry and immunoassay)
can spend our time focusing on patients and getting results out.”
— Dr. Joseph Litten, PhD, Corporate Technical and Lab Instrumentation
 2 c8000s, 3 i2000SR, 2 Sapphires,
Development Manager, Valley Health Systems
1 SMS, 1 PathFinder, 5 c4000s,
5 i1000SR, 4 Rubys

Six Sigma also delivers improvements in operational

costs: 45% savings in supplies for running controls, or
$73,000 (USD) in annual material savings
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Six Sigma performance and instrument KNOW

consolidation deliver true value

ARCHITECT can provide instrument consolidation while delivering
faster turnaround-time and improved Six Sigma performance

LABORATORY STATISTICS

Hospital
CHRISTUS Health System
San Antonio, TX

Size
4 hospitals, surgery hospital and 3 free
standing emergency centers

Key Message
 Reduced turnaround-time (TAT)
 -17.3% for CC
 -22.2% for IA
 Testing platform consolidation
 10 to 4
“Every Six Sigma analysis  Vendor consolidation
that I’ve seen has always  4 to 1
 $2.3 MM savings over 7 years
shown that the Abbott line  Improved Six Sigma performance
 6 assays improved to 5 sigma
is far superior than most or better
 Assays performing at
others.” – Christopher Otto, MS, MLS “Not only is ARCHITECT better in terms of <3 sigma decreased
excellent and world-class performance, it has
(ASCP) DLM, Chemistry Supervisor and
significant fewer assays that are problematic.”
Regional Coordinator for CHRISTUS Health
– Sten Westgard, Director, Westgard QC
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 KNOW

Proven Six Sigma performance enhances quality control

With increasing demands for improved accuracy and reliability of results, Six Sigma
is revolutionizing how clinical laboratories measure quality control. Assay and
instrument developers at Abbott understand the value of Six Sigma performance
and apply it to quantify performance on diagnostic systems.

• Patient flow is improved through

reduced result turnaround time
and operator intervention with
sample processing

• ARCHITECT systems demonstrate

excellent result equivalency and
Six Sigma performance

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World-class Six Sigma assay performance KNOW

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World-class Six Sigma assay performance KNOW

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Conclusion CONCLUSION

By Applying Six Sigma into Laboratory Practices, we learn:

- Sigma can be implemented to evaluate assay quality and assist in selection
of analytical system;
- Monitoring performance –multiple analyzers, multiple sites;
- Tool for Continuous quality improvement (CQI) activity;
- Formulate QC strategy and implication on cost.

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