Journal Information
Journal ID (publisher-id): BM
Journal ID (nlm-ta): Biochem Med (Zagreb)
Title: Biochemia Medica
Abbreviated Title: Biochem. Med. (Zagreb)
ISSN (print): 1330-0962
ISSN (electronic): 1846-7482
Publisher: Croatian Society of Medical Biochemistry and Laboratory Medicine
Article Information
Copyright statement: ©Croatian Society of Medical Biochemistry and Laboratory Medicine.
Copyright: 2018, Croatian Society of Medical Biochemistry
License (open-access):
This is an Open Access article distributed under the terms of the Creative Commons Attribution (http://creativecommons.org/licenses/by/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Date received: 31 July 2018
Date accepted: 25 September 2018
Publication date (electronic): 15 December 2018
Publication date (print): 15 February 2019
Volume: 29
Issue: 1
Electronic Location Identifier: 010701
Publisher ID: bm-29-1-010701
DOI: 10.11613/BM.2019.010701
Standardization in laboratory medicine: Two years’ experience from category 1 EQA programs in Spain
Montserrat Ventura[6]
Sandra Bullich[6]
Virtudes Alvarez[1]
Pilar Fernández-Fernández[1]
[1] Spanish Society of Laboratory Medicine (SEQCML), Analytical Quality Commission, Barcelona, Spain
[2] Clinical Laboratory Department, Vall d’Hebron Barcelona Hospital Campus, Barcelona, Spain
[3] Aragonese Health Service, Royo Villanova Hospital, Zaragoza, Spain
[4] Quality Healthcare Consulting, ACMS Group, Madrid, Spain
[5] La Paz University Hospital, Madrid, Spain
[6] External Quality Assurance Programs, SEQCML, Barcelona, Spain
[7] Clinical Analysis Service, Hospital San Agustin, Aviles, Principality of Asturias, Spain
[8] Metropolitana Nord Unified Laboratory (LUMN), Germans Trias I Pujol University Hospital, Badalona, Spain
[9] Department of Clinical Biochemistry, University Hospital of Salamanca, Salamanca, Spain
[10] Intercomarcal laboratory consortiums of Alt Penedès, Anoia and Garraf, Barcelona, Spain
[11] Clinical Laboratory, Hospital Campus de la Salud, Granada, Spain
Author notes:
[*] Corresponding author: cricosaguila@gmail.com
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
