Standardization in laboratory medicine: Two years’ experience from category 1 EQA programs in Spain

Author:

Ricós Carmen1,Bullich Sandra2,Fernández-Calle Pilar3,Fernández-Fernández Pilar1,García-Lario José-Vicente4,Alvarez Virtudes1,Simón Margarita5,Marques Fernando6,Minchinela Joana7,Corte Zoraida8,Ventura Montserrat2,Diaz-Garzón Jorge3,González-Lao Elisabet9,Boned Beatriz10,Perich Carmen11

Affiliation:

1. Spanish Society of Laboratory Medicine (SEQCML), Analytical Quality Commission, Barcelona, Spain

2. External Quality Assurance Programs, SEQCML, Barcelona, Spain

3. Spanish Society of Laboratory Medicine (SEQCML), Analytical Quality Commission, Barcelona, Spain; La Paz University Hospital, Madrid, Spain

4. Spanish Society of Laboratory Medicine (SEQCML), Analytical Quality Commission, Barcelona, Spain; Clinical Laboratory, Hospital Campus de la Salud, Granada, Spain

5. Spanish Society of Laboratory Medicine (SEQCML), Analytical Quality Commission, Barcelona, Spain; Intercomarcal laboratory consortiums of Alt Penedès, Anoia and Garraf, Barcelona, Spain

6. Spanish Society of Laboratory Medicine (SEQCML), Analytical Quality Commission, Barcelona, Spain; Department of Clinical Biochemistry, University Hospital of Salamanca, Salamanca, Spain

7. Spanish Society of Laboratory Medicine (SEQCML), Analytical Quality Commission, Barcelona, Spain; Metropolitana Nord Unified Laboratory (LUMN), Germans Trias I Pujol University Hospital, Badalona, Spain

8. Spanish Society of Laboratory Medicine (SEQCML), Analytical Quality Commission, Barcelona, Spain; Clinical Analysis Service, Hospital San Agustin, Aviles, Principality of Asturias, Spain

9. Spanish Society of Laboratory Medicine (SEQCML), Analytical Quality Commission, Barcelona, Spain; Quality Healthcare Consulting, ACMS Group, Madrid, Spain

10. Spanish Society of Laboratory Medicine (SEQCML), Analytical Quality Commission, Barcelona, Spain; Aragonese Health Service, Royo Villanova Hospital, Zaragoza, Spain

11. Spanish Society of Laboratory Medicine (SEQCML), Analytical Quality Commission, Barcelona, Spain; Clinical Laboratory Department, Vall d’Hebron Barcelona Hospital Campus, Barcelona, Spain

Abstract

Introduction: Standardization is the ability to obtain interchangeable results leading to same medical interpretation. External quality assessment (EQA) is the main support of the on-going harmonization initiatives. Aim of study was to evaluate results obtained from two years category 1 EQA program experience in Spain and determine the impact of applying this type of EQA program on the analytical standardization. Materials and methods: According to the analytical method, traceability and instrument different groups were established which results were evaluated by calculating mean, coefficient of variation and percent of deviation to the reference value. Analytical performance specifications used to the results' evaluation were derived from biological variation for bias and from the inter-laboratory coefficients of variation found in a previous pilot study. Results: Only creatinine measured by enzymatic methods gave excellent results, although few laboratories used this method. Creatine kinase and GGT gave good precision and bias in all, but one instrument studied. For the remaining analytes (ALT, ALP, AST, bilirubin, calcium, chloride, glucose, magnesium, potassium, sodium, total protein and urate) some improvement is still necessary to achieve satisfactory standardization in our setting. Conclusions: The two years of category 1 EQA program experience in Spain have manifested a lack of standardization of 17 most frequent biochemistry tests used in our laboratories. The impact of the information obtained on the lack of standardization is to recommend abandoning methods such as ALT, AST without exogenous pyridoxal phosphate, Jaffe method for creatinine, and do not use non-commutable calibrators, such as aqueous solutions for calcium and sodium.

Publisher

Croatian Society for Medical Biochemistry and Laboratory Medicine

Subject

Biochemistry, medical,Clinical Biochemistry

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5. González-Lao E, Díaz-Garzón J, Ricós C, Álvarez V. Fernández- Calle P, et al. Category 1 External Quality Assurance Program for serum Alanine Aminotransferase and Aspartate Aminotransferase. European Congress of Clinical Chemistry and Laboratory Medicine. Athens 2017. Available at: https://www.degruyter.com/view/j/cclm.2017.55.issue-s1/issue-files/cclm.2017.55.issue-s1.xml. Accessed September 19th 2018.

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