Original scientific paper

https://doi.org/10.11613/BM.2019.010701

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

Carmen Ricós ; Spanish Society of Laboratory Medicine (SEQCML), Analytical Quality Commission, Barcelona, Spain
Carmen Perich ; Spanish Society of Laboratory Medicine (SEQCML), Analytical Quality Commission, Barcelona, Spain; Clinical Laboratory Department, Vall d’Hebron Barcelona Hospital Campus, Barcelona, Spain
Beatriz Boned ; Spanish Society of Laboratory Medicine (SEQCML), Analytical Quality Commission, Barcelona, Spain; Aragonese Health Service, Royo Villanova Hospital, Zaragoza, Spain
Elisabet González-Lao ; Spanish Society of Laboratory Medicine (SEQCML), Analytical Quality Commission, Barcelona, Spain; Quality Healthcare Consulting, ACMS Group, Madrid, Spain
Jorge Diaz-Garzón ; Spanish Society of Laboratory Medicine (SEQCML), Analytical Quality Commission, Barcelona, Spain; La Paz University Hospital, Madrid, Spain
Montserrat Ventura ; External Quality Assurance Programs, SEQCML, Barcelona, Spain
Sandra Bullich ; External Quality Assurance Programs, SEQCML, Barcelona, Spain
Zoraida Corte ; Spanish Society of Laboratory Medicine (SEQCML), Analytical Quality Commission, Barcelona, Spain; Clinical Analysis Service, Hospital San Agustin, Aviles, Principality of Asturias, Spain
Joana Minchinela ; Spanish Society of Laboratory Medicine (SEQCML), Analytical Quality Commission, Barcelona, Spain; Metropolitana Nord Unified Laboratory (LUMN), Germans Trias I Pujol University Hospital, Badalona, Spain
Fernando Marques ; Spanish Society of Laboratory Medicine (SEQCML), Analytical Quality Commission, Barcelona, Spain; Department of Clinical Biochemistry, University Hospital of Salamanca, Salamanca, Spain
Margarita Simón ; Spanish Society of Laboratory Medicine (SEQCML), Analytical Quality Commission, Barcelona, Spain; Intercomarcal laboratory consortiums of Alt Penedès, Anoia and Garraf, Barcelona, Spain
Virtudes Alvarez ; Spanish Society of Laboratory Medicine (SEQCML), Analytical Quality Commission, Barcelona, Spain
José-Vicente García-Lario ; Spanish Society of Laboratory Medicine (SEQCML), Analytical Quality Commission, Barcelona, Spain; Clinical Laboratory, Hospital Campus de la Salud, Granada, Spain
Pilar Fernández-Fernández ; Spanish Society of Laboratory Medicine (SEQCML), Analytical Quality Commission, Barcelona, Spain
Pilar Fernández-Calle ; Spanish Society of Laboratory Medicine (SEQCML), Analytical Quality Commission, Barcelona, Spain; La Paz University Hospital, Madrid, 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.

Keywords

standardization; external quality assessment; traceability; bias

Hrčak ID:

213855

URI

https://hrcak.srce.hr/213855

Publication date:

15.2.2019.

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