Tools, Technologies and Training for Healthcare Laboratories

A Dimension EXL in Ethiopia

A study looked at the Sigma metrics across all three phases of the total testing process in a specialized hospital in Ethiopia. An interesting look at performance outside the usual setting.

Sigma metrics across the Total Testing Process at Dessie Comprehensive Specialized Hospital

December 2025
Sten Westgard, MS

 

A recent study from the Dessie Comprehensive Specialist Hospital in Ethiopia looked at Sigma performance across the total testing process, as well as analytical Sigma metrics of a Dimension EXL: 

Performance Analysis of Clinical Chemistry Laboratory Using Sigma Metrics in the Total Testing Process at Dessie Comprehensive Specialized Hospital, Ethiopia. Multaie Z, Ebrahim E, Alebachew M, Gedefie A, Eshetu B, Tilahun M, Debash H, Kassa Y, Alemayehu E, Gessese T. Journal of Clinical Laboratory Analysis 2025;0;e70134
https://doi.org/10.1002/jcla.70134

Pre-analytical phase Sigma performance, Ethiopia

 2025 12 1 Ethiopia Pre Analytical Metrics

Some of the individual metrics are good, but the Sigma for the whole pre-analytical phase (total) is below 3. 

 

Analytical phase Sigma-metrics, Ethiopia

2025 12 1 Ethiopia Analytical Metrics

The worst performance in the analytical phase comes from missing scheduled maintenance and releasing non-linear results, but overall the analytical phase scores 3.5 Sigma.

Post-analytical phasse Sigma-metrics, Ethiopia

2025 12 1 Ethiopia post Analytical Metrics

This lab appears to release results without verification quite often, resulting in a below 1 Sigma performance. Overall, the post-analytical phase is below 3 Sigma.

Overall, the only phase that is above 3 Sigma is the analytical phase. However, we're going to challenge that bit of good news by looking more closely into the test by test performance of the chemistry instrument, a Dimension EXL.

Calculating Sigma metrics from routine laboratory performance data

[If you need a refresher on Sigma-metrics, check that out here. In this current section of the website, there are hundreds of real-world examples to review.]

Unfortunately, the authors made a mistake in calculation of the analytical Sigma metric, where they didn't use the absolute bias, but instead retained it's sign. When this kind of error is made, a negative bias will have it's sign reversed, and suddenly the TEa is larger, not smaller in the Sigma metric equation.  That means in a few cases, the Sigma metrics are higher than they should be. Our analysis here makes the correct use of bias (always absolute, never increasing TEa), but in addition we will be applying CLIA 2025 goals, not the CLIA 1992 goals.

Test TEa Source TEa % Bias % CV Sigma
Albumin CLIA 2025 8 10.4 3.59 negative
Albumin 8% 8 10.4 4.57 negative
Alk Phos CLIA 2025 20 1.5 4.79 3.87
Alk Phos 20% 20 1.5 4.26 4.35
ALT CLIA 2025 15 1.4 4.45 3.06
ALT 6 U/L or 15% 15 1.4 4.04 3.37
AST CLIA 2025 15 6.5 3.46 2.44
AST 6 U/L or 15% 15 6.5 3.25 2.60
Bilirubin, Direct Ricos 2014 Desirable 44.5 20.3 21.12 1.14
Bilirubin, Direct 44.50% 44.5 20.3 7.68 3.15
Bilirubin, Total CLIA 2025 20 6.0 6.73 2.08
Bilirubin, Total   20 6.0 2.14 6.54
Chloride CLIA 2025 5 4.8 2.59 0.07
Chloride 5% 5 4.8 1.91 0.09
Cholesterol CLIA 2025 10 6.6 3.4 0.99
Cholesterol 10% 10 6.6 3.84 0.88
Creatinine CLIA 2025 10% or 10 1.4 3.63 2.37
Creatinine 0.2 mg/dL 10 1.4 2.08 4.13
Glucose CLIA 2025 8% or 8 0.6 3.19 2.32
Glucose 6 mg/dL 8 0.6 3.64 2.03
HDL CLIA 2025 20 17.0 6.4 0.47
HDL 6 mg/dl or 20% 20 17.0 3.2 0.95
LDL CLIA 2025 20 5.2 5.85 2.53
LDL 20% 20 5.2 4.57 3.24
LDH CLIA 2025 15 2.7 3.64 3.38
LDH 15% 15 2.7 2.4 5.13
Potassium CLIA 2025 8.05 2.4 2.47 2.30
Potassium 0.3 mmol/L 8.05 2.4 1.66 3.43
Protein, Total CLIA 2025 8 2.9 1.42 3.61
Protein, Total 8% 8 2.9 2.43 2.11
Sodium CLIA 2025 2.85 1.2 1.69 0.99
Sodium 4 mmol/L 2.85 1.2 1.05 1.59
Triglycerides CLIA 2025 15 0.2 2.94 5.04
Triglycerides 15% 15 0.2 3.45 4.29
Urea Nitrogen CLIA 2025 9 0.8 7.86 1.04
Urea Nitrogen 2.0 mg/dL or 9% 9 0.8 6.73 1.22
Uric Acid CLIA 2025 10 2.3 2.06 3.72
Uric Acid 10% 10 2.3 1.53 5.01


As the table shows, there are a lot of metrics below Three Sigma. To be precise, 57% of the performance is below 3 Sigma. The majority of this platform would be considered unacceptable by CLIA 2025 standards. 

 Graphic Display of performance by Normalized Method Decision Chart (NMEDx)

2025 12 2 Ethiopia Dim EXL NMEDx


Only one level of this instrument achieves 6 Sigma. In order to properly QC this instrument, pretty much all the Westgard Rules need to be used on pretty much all the tests. Even then, the lab would be well advised to use calculations like the Critical Difference, or Reference Change Value, to help clinicians sift out the patient's signal from the laboratory's noise.

Conclusion

It's very hard to look at this performance, at any phase of the total testing performance, and not feel a sense of tragedy. Challenges in the developing world are hard enough, but even in the best hospitals, there are serious errors occurring. The performance here is a world apart from what we see in the Europe, USA, and other advanced economies. Modern instruments, in different countries, can behave very differently. 

 

 

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