Standardization in laboratory medicine: Two years’ experience from category 1 EQA programs in Spain
| Autor: | Carmen Ricós, Carmen Perich, Pilar Fernández-Fernández, José-Vicente García-Lario, Elisabet González-Lao, Beatriz Boned, Pilar Fernandez-Calle, Virtudes Alvarez, Fernando Marqués, Joana Minchinela, Montserrat Ventura, Margarita Simón, Sandra Bullich, Jorge Díaz-Garzón, Zoraida Corte |
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| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
030213 general clinical medicine
medicine.medical_specialty bias standardization external quality assessment traceability Standardization Quality Assurance Health Care Coefficient of variation Clinical Biochemistry Medical laboratory 030204 cardiovascular system & hematology 03 medical and health sciences 0302 clinical medicine Biological variation External quality assessment Medicine Humans Medical physics Creatine Kinase Total protein business.industry Clinical Laboratory Techniques Biochemistry (medical) Original Articles gamma-Glutamyltransferase Spain Creatinine business |
| Zdroj: | Biochemia Medica Volume 29 Issue 1 Repositorio Institucional de la Consejería de Sanidad de la Comunidad de Madrid Consejería de Sanidad de la Comunidad de Madrid r-IGTP. Repositorio Institucional de Producción Científica del Instituto de Investigación Germans Trias i Pujol instname |
| ISSN: | 1846-7482 1330-0962 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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