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Standardization in laboratory medicine: Two years' experience from category 1 EQA programs in Spain
Carmen Ricós1, Carmen Perich1,2, Beatriz Boned1,3
1Spanish Society of Laboratory Medicine (SEQCML), Analytical Quality Commission, Barcelona, Spain.
Biochemia Medica
|December 29, 2018
Summary
Two years of external quality assessment (EQA) in Spain revealed poor analytical standardization for 17 common biochemistry tests. Recommendations include abandoning certain methods and calibrators to improve laboratory results and medical interpretation.
Area of Science:
- Clinical Chemistry
- Laboratory Medicine
- Analytical Chemistry
Background:
- External Quality Assessment (EQA) programs are crucial for harmonizing laboratory results and ensuring consistent medical interpretation.
- This study evaluates a two-year Category 1 EQA program in Spain to assess its impact on analytical standardization.
Purpose of the Study:
- To evaluate the analytical standardization of 17 frequent biochemistry tests based on two years of Category 1 EQA program data from Spain.
- To determine the impact of the EQA program on achieving analytical standardization in participating laboratories.
Main Methods:
- Results were grouped by analytical method and instrument, evaluating mean, coefficient of variation, and percent deviation from reference values.
- Performance specifications were based on biological variation for bias and inter-laboratory coefficients of variation from a pilot study.
Main Results:
- Enzymatic creatinine methods showed excellent results, but were infrequently used.
- Creatine kinase and Gamma-Glutamyl Transferase (GGT) demonstrated good precision and bias across most instruments.
- Significant improvements are needed for ALT, ALP, AST, bilirubin, calcium, chloride, glucose, magnesium, potassium, sodium, total protein, and urate standardization.
Conclusions:
- The EQA program highlighted a lack of standardization for 17 common biochemistry tests in Spanish laboratories.
- Specific methods (e.g., Jaffe for creatinine, ALT/AST without pyridoxal phosphate) and non-commutable calibrators (e.g., aqueous solutions for calcium/sodium) should be reconsidered or abandoned.