AACC 2006 ODC Workshop

1. Fernando Berlitz

2. "Do you know what you're paying for? How Four
Laboratories used 21st Century Metrics to find out."
"Using Process Excellence, Lean, and Six Sigma
metrics employed by other industries, this workshop
describes how these metrics were applied to the
acquisition of instrumentation in the clinical chemistry
laboratory. In doing so, previously unrealized costs
and potentials for error were revealed.

3. Weinmann Laboratory brief presentation
• Founded in 1929
• Areas:
-Laboratory Medicine
-Blood Banking
• 2 brands in market:
Acquisition in 2001

4. Weinmann Laboratory brief presentation
• Serves 612.000 patients/year
- 25 Patient Service Centers
- 2 Hospitals
• Total tests per year: 4.100.000
• Revenue: ~ US$ 18 million per year
• Employees: 508
•Surveys:
– CAP
– PELM
• Scientific Production:
– AACC: 33 posters presented since 1997

5. Our Vision
“To be a national reference in
Laboratory Medicine, overcoming our
own competitive level in order to sustain
this position in any scenario and develop
the Healthcare Area”

6. Weinmann´s Quality Evolution
• 1993: TQM implementation
• 1997: 5S implementation
• 1998: Excellence criteria
– First PQRS Award
• 2000: ISO 9002:1994 certification
• 2002: PALC accreditation
- Brazilian National Lab Accreditation Program
• 2003: ISO 9001:2000 certification
• 2005: Lean Six Sigma implementation
– First DMAIC project

7. Automation Evolution
• 1995: Dry Chemistry implementation
• VITROS 750, VITROS 250, VITROS 950
-quality performance background,
Choice reasons
-technical characteristics (water supply needs, assay
menu,...)
Performance -method comparison procedure against previous
Evaluation routine methods (Bias evaluation)
-allowed process standardization (ISO 9002:1994 Lab
certification),
Advantages -easier operator training,
-quality performance results improved (Bias,
imprecision, TAT).
Disadvantages -Higher costs (assays costs)

8. Automation Evolution
• 2003: Wet Chemistry implementation
-Marketplace change
Choice reasons
-Assays costs
Performance
-Method validation protocols (CLSI EP protocols)
Evaluation
-High throughput,
Advantages
-Low assays costs
-Elevated setup time,
Disadvantages Reproductibility problems,
Water supply needs and waste management

9. Automation Evolution
• 2006: Dry Chemistry return
• VITROS FS 5,1
-Improve quality performance (based on Weinmann´s
Choice reasons
published study using Sigma-metrics),
-TAT reduction (Setup reduction)
Performance -CLSI evaluations protocols using specific software
Evaluation (EP evaluator),
-Including Sigma-metrics analysis
-Larger menu on a single instrument,
Advantages -Water supply needs,
-Higher reproductibility
-Improve our clinical chemistry section process
Expectation performance (process sigma level of 3,76 using our
wet chemistry analyzer by OCD process study)

10. Instruments comparison using sigma-metrics
Objectives
•Quality performance comparison between two automated
chemistry systems (V950 and Routine Method), using sigma-
metrics
• Comparison between sigma-metrics obtained with different
source of specifications
• Customize procedures of QC based on performance obtained
in this study
Methods
•10 assays analyzed:
Urate, Calcium, Total Cholesterol, Creatinine, ALT, AST,
Glucose, Potassium, Total Proteins, Tryglycerides

11. Instruments comparison using sigma-metrics
Internal QC results PT results
(imprecision, 2003, (CAP, 2002-04,
6 months, Mean CV%) Mean SDi, Bias%)
Analytical Specification *
Sigma-metrics
∆SEc
Quality System Design
* CLIA, BV and Clinical criteria

12. Instruments comparison using sigma-metrics

13. Instruments comparison using sigma-metrics
Conclusion
– Metrics Comparison:
* Routine Method problems:
→
Enzymes: Lower performance (Bias and CV%)
– Equipment needs and Characteristics:
* Routine Method disadvantages:
→ Water supply
→ Higher daily setup
→ Time-consuming Maintenance routine
→ Higher frequency of Calibration
– Dry Chemistry Method Mainly Advantages:
∗ Lower Setup Time, Lower TAT
∗ Lower frequency of Calibration
∗ High Precision, Low Bias (PT)
∗ Layout advantages (Water)

14. Instruments comparison using sigma-metrics
Using Routine Method
as reference for Bias%
determination

15. Instruments comparison using sigma-metrics
Using Routine Method
as reference for Bias%
determination

16. Quality Tools and Automation Decision
• 5S, Lean:
– Non-value added activities elimination
– Process flow
– Equipment requirements:
∗ Larger menu on a single instrument
∗ Low Setup, low TAT
∗ Adequate Layout (water supply)
• Six Sigma:
– Reduce Process Variation
– Equipment requirements:
∗ High reproductibility
∗
High process padronization

17. Quality Tools and Automation Decision
“Dry Chemistry allowed the achievement of our
process improvement goals through our Lean Six
Sigma initiatives in chemistry section technical
processes”

18. Thank you!
Fernando Berlitz
fberlitz@weinmann.com.br