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Biochem Med (Zagreb) ; 30(1): 010704, 2020 Feb 15.
Artigo em Inglês | MEDLINE | ID: mdl-31839724


Introduction: Diabetes mellitus (DM) is one of the most prevalent diseases worldwide. The objective of this study was to find out under what preanalytical conditions routine and diagnostic glucose tests are performed across Spanish laboratories; and also what criteria are used for DM diagnosis. Materials and methods: An online survey was performed by the Commission on Quality Assurance in the Extra-Analytical Phase of the Spanish Society of Laboratory Medicine (SEQC-ML). Access to the questionnaire was available on the home page of the SEQC-ML website during the period April-July 2018. Data analysis was conducted with the IBM SPSS© Statistics (version 20.0) program. Results: A total of 96 valid surveys were obtained. Most laboratories were in public ownership, serving hospital and primary care patients, with high and medium workloads, and a predominance of mixed routine-urgent glucose testing. Serum tubes were the most used for routine glucose analysis (92%) and DM diagnosis (54%); followed by lithium-heparin plasma tubes (62%), intended primarily for urgent glucose testing; point-of-care testing devices were used by 37%; and plasma tubes with a glycolysis inhibitor, mainly sodium fluoride, by 19%. Laboratories used the cut-off values and criteria recognized worldwide for DM diagnosis in adults and glucose-impaired tolerance, but diverged in terms of fasting plasma glucose and gestational DM criteria. Conclusion: Preanalytical processing of routine and DM diagnostic glucose testing in Spain does not allow a significant, non-quantified influence of glycolysis on the results to be ruled out. Possible adverse consequences include a delay in diagnosis and possible under-treatment.

Glicemia/análise , Coleta de Amostras Sanguíneas/métodos , Coleta de Amostras Sanguíneas/instrumentação , Diabetes Mellitus/diagnóstico , Humanos , Laboratórios Hospitalares/normas , Fase Pré-Analítica , Espanha , Inquéritos e Questionários
Biochem Med (Zagreb) ; 29(1): 010701, 2019 Feb 15.
Artigo em Inglês | MEDLINE | ID: mdl-30591811


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.

Técnicas de Laboratório Clínico/normas , Creatina Quinase/sangue , Creatinina/sangue , gama-Glutamiltransferase/sangue , Humanos , Garantia da Qualidade dos Cuidados de Saúde , Espanha
Clin Chem Lab Med ; 55(4): 530-538, 2017 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-27658151


BACKGROUND: Preanalytical variables, such as sample collection, handling and transport, may affect patient results. Preanalytical phase quality monitoring should be established in order to minimize laboratory errors and improve patient safety. METHODS: A retrospective study (2001-2013) of the results obtained through the Spanish Society of Clinical Biochemistry and Molecular Pathology (SEQC) External quality assessment (preanalytical phase) was performed to summarize data regarding the main factors affecting preanalytical phase quality. Our aim was to compare data from 2006 to 2013 with a previously published manuscript assessing the 2001-2005 period. RESULTS: A significant decrease in rejection rates was observed both for blood and urine samples. For serum samples, the most frequent rejection causes in the first period were non-received samples (37.5%), hemolysis (29.3%) and clotted samples (14.4%). Conversely, in the second period, hemolysis was the main rejection cause (36.2%), followed by non-received samples (34.5%) and clotted samples (11.1%). For urine samples, the main rejection cause overall was a non-received sample (up to 86.1% of cases in the second period, and 81.6% in the first). For blood samples with anticoagulant, the number of rejections also decreased. While plasma-citrate-ESR still showed the highest percentages of rejections (0.980% vs. 1.473%, p<0.001), the lowest corresponded to whole-blood EDTA (0.296% vs. 0.381%, p<0.001). CONCLUSIONS: For the majority of sample types, a decrease in preanalytical errors was confirmed. Improvements in organization, implementation of standardized procedures in the preanalytical phase, and participation in a Spanish external quality assessment scheme may have notably contributed to error reduction in this phase.

Técnicas de Laboratório Clínico/normas , Controle de Qualidade , Manejo de Espécimes/normas , Coleta de Amostras Sanguíneas/normas , Hemólise , Humanos , Laboratórios/normas , Ensaio de Proficiência Laboratorial/métodos , Estudos Retrospectivos , Espanha , Urinálise/normas
Clin Chem Lab Med ; 51(9): 1739-46, 2013 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-23612663


BACKGROUND: Verification uses logical algorithms to detect potential errors before laboratory results are released to the clinician. Even though verification is one of the main processes in all laboratories, there is a lack of standardization mainly in the algorithms used and the criteria and verification limits applied. A survey in clinical laboratories in Spain was conducted in order to assess the verification process, particularly the use of autoverification. METHODS: Questionnaires were sent to the laboratories involved in the External Quality Assurance Program organized by the Spanish Society of Clinical Biochemistry and Molecular Pathology. Seven common biochemical parameters were included (glucose, cholesterol, triglycerides, creatinine, potassium, calcium, and alanine aminotransferase). RESULTS: Completed questionnaires were received from 85 laboratories. Nearly all the laboratories reported using the following seven verification criteria: internal quality control, instrument warnings, sample deterioration, reference limits, clinical data, concordance between parameters, and verification of results. The use of all verification criteria varied according to the type of verification (automatic, technical, or medical). Verification limits for these parameters are similar to biological reference ranges. Delta Check was used in 24% of laboratories. Most laboratories (64%) reported using autoverification systems. Autoverification use was related to laboratory size, ownership, and type of laboratory information system, but amount of use (percentage of test autoverified) was not related to laboratory size. CONCLUSIONS: A total of 36% of Spanish laboratories do not use autoverification, despite the general implementation of laboratory information systems, most of them, with autoverification ability. Criteria and rules for seven routine biochemical tests were obtained.

Bioquímica/métodos , Técnicas de Laboratório Clínico/métodos , Adulto , Algoritmos , Bioquímica/normas , Sistemas de Informação em Laboratório Clínico , Técnicas de Laboratório Clínico/normas , Humanos , Masculino , Garantia da Qualidade dos Cuidados de Saúde/métodos , Padrões de Referência , Espanha , Inquéritos e Questionários
Ther Drug Monit ; 29(5): 662-5, 2007 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-17898661


Data on the stability of drugs of abuse in oral fluid are needed to define the optimal transportation and storage conditions when this biological fluid has to be used for off-site screening and confirmation analyses, as well as in the preparation of reference material for external quality assessment schemes. The short-term and long-term stability of opiates, cocaine, amphetamines, and methylenedioxy derivatives in unstimulated oral fluid was evaluated in different storage conditions, with and without the addition of citrate buffer and sodium azide. Short-term stability was evaluated at 25 degrees C and 37 degrees C for up to 7 days. Long-term stability was evaluated at different time intervals for up to 2 months at 4 degrees C and -20 degrees C. The effect of three different freezing and thawing cycles was also studied. No significant loss of amphetamines and methylenedioxy derivatives, morphine, codeine, and benzoylecgonine was observed under any of the investigated conditions. Conversely, hydrolysis of the ester bonds of cocaine and 6-MAM, leading to the formation of benzoylecgonine and morphine, respectively, was observed under all the applied conditions when oral fluid was not buffered and preserved. The addition of citrate buffer (pH, 4) and sodium azide (0.1%) to oral fluid prevented their degradation during up to 7 days of storage at 25 degrees C and 37 degrees C and up to 2 months at 4 degrees C and -20 degrees C. The stability of the principal illicit drugs spiked in buffered and stabilized oral fluid is adequate for transportation of collected samples at ambient temperature and for shipment and storage of reference materials for external quality assessment schemes.

/química , Saliva/química , Transtornos Relacionados ao Uso de Substâncias/diagnóstico , Cocaína/química , Armazenamento de Medicamentos , Humanos , Derivados da Morfina/química , Controle de Qualidade , Valores de Referência , Detecção do Abuso de Substâncias/normas
Radiother Oncol ; 82(1): 50-4, 2007 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-17150270


BACKGROUND AND PURPOSE: The Patterns of Care for Brachytherapy in Europe (PCBE) study is aimed at establishing a detailed information system on brachytherapy throughout Europe. MATERIALS AND METHODS: The questionnaire was web-based and the analysis used data from each radiotherapy department with brachytherapy. There were three groups: Group I with 19 countries (15 initial European Community (EC) countries plus Iceland, Monaco, Norway and Switzerland -EC+4-), Group II with 10 countries (New European Community countries -NEC-) and Group III with 14 countries (Other European Countries -OEC-). RESULTS: In the European area there are 36 of 43 countries (85%) which achieved data collection from at least 50% of centres, and were included in the analysis. The tumour site that had the largest number of treated patients was gynaecological tumours. Several variations have been found in the mean number of patients treated per consultant radiation oncologist and physicist; and in the proportion of brachytherapy patients with gynaecology, prostate and breast tumours, by country and by European area. The provided data showed that the average number of brachytherapy patients per centre increased by 10% between 1997 and 2002. CONCLUSIONS: A European wide evaluation of brachytherapy practice using a web-based questionnaire is feasible and that there is considerable variation in both patterns of practice and available resources.

Braquiterapia/estatística & dados numéricos , Neoplasias/radioterapia , Serviço Hospitalar de Radiologia/estatística & dados numéricos , Braquiterapia/métodos , Europa (Continente) , Pesquisas sobre Serviços de Saúde/métodos , Humanos , Internet , Neoplasias/epidemiologia , Inquéritos e Questionários
Clin. transl. oncol. (Print) ; 8(7): 491-499, jul. 2006. graf
Artigo em Inglês | IBECS | ID: ibc-047704


No disponible

Purpose. The main objective of the program «Patternsof Care for Brachytherapy in Europe (PCBE)»is to establish a group with detailed information onbrachytherapy throughout Europe.Methods. The data was compiled by the general coordinator,the ESTRO, and the «National CancerServices Analysis» through a website.Results. A total of 32 countries reported data from atleast 50% of their centres (criteria of inclusion).Countries were grouped in three categories based onthe time of incorporation to the European Union. Themajority of treatments belonged to gynaecological tumours.A large spread was found regarding workloadof specialists depending on centre and group.Conclusion. Collection of information by a websiteis a feasible methodology. An increase in brachytherapytreatment was observed in all 3 groups by arate of more than 20% (year 2002 versus year 1997).These results advocate for the continuation of thePCBE study to demonstrate the development in thefield, such as an increase or decrease of patientnumbers per tumour category

Humanos , Braquiterapia/métodos , Radioterapia/instrumentação , Neoplasias/radioterapia , União Europeia , Protocolos Antineoplásicos , Recursos em Saúde