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

RESUMO

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.


Assuntos
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
2.
Rev. lab. clín ; 12(4): e54-e65, oct.-dic. 2019. ilus, tab
Artigo em Espanhol | IBECS-Express | ID: ibc-ET1-4182

RESUMO

El aseguramiento de la calidad de la fase preanalítica se orienta hacia 2 aspectos clave: la gestión de los errores preanalíticos desde la perspectiva de la seguridad del paciente, y la mejora y armonización de los procedimientos, basada en la aplicación de normativa además de recomendaciones profesionales. Al igual que el resto de las fases, debe incluir un programa interno de aseguramiento y la participación en programas de intercomparación entre laboratorios. El control de calidad interno debe basarse fundamentalmente en la identificación de riesgos, detección sistemática de errores y establecimiento de indicadores. La selección de los indicadores priorizando el impacto en el paciente, la forma de detectar y registrar los errores de forma sistemática y fácilmente explotable, así como las variables utilizadas en su cálculo, son aspectos importantes para medir la eficacia de las acciones de mejora y permitir la comparabilidad entre laboratorios. En este sentido, los programas externos de la calidad de la fase preanalítica basados en la comparación de indicadores, son una herramienta útil para el diseño e implantación de un programa de aseguramiento de la calidad. Este documento pretende servir de apoyo para que cada laboratorio seleccione, implante y evalúe sus propios indicadores, de acuerdo a las características individuales de sus procedimientos preanalíticos, pero sin perder de vista la armonización entre laboratorios


The quality assurance of the pre-analytical phase is oriented towards two key aspects; the management of pre-analytical errors from the perspective of patient safety, and the improvement and harmonisation of procedures, based on the application of regulations and professional recommendations. Like the rest of the phases, it should include an internal quality assurance program, as well as the participation in external quality assurance programs. The internal quality control should mainly be based on the identification of risks, systematic detection of errors, and establishment of indicators. The selection of indicators prioritising the impact on the patient, the way to detect and record errors in a systematic and easily exploitable manner, and also the variables used in the calculations, are important aspects to measure the effectiveness of improvement actions and to allow comparability between laboratories. In this sense, the external quality assurance programs of the pre-analytical phase based on the comparison of indicators are a useful tool for the design and implementation of a quality assurance program. This document is intended as a support for each laboratory to select, implement, and evaluate its own indicators, according to the individual characteristics of its pre-analytical procedures, but without losing sight of the harmonisation between laboratories

3.
Rev. lab. clín ; 12(4): e66-e74, oct.-dic. 2019.
Artigo em Espanhol | IBECS-Express | ID: ibc-ET1-4183

RESUMO

El análisis de gases en sangre es una prueba frecuentemente solicitada en diferentes ámbitos hospitalarios. La medida de los parámetros incluidos en este análisis puede verse afectada por un elevado número de condiciones preanalíticas y es responsabilidad del laboratorio garantizar que los resultados reflejan de forma segura el equilibrio ácido-base y el estado de oxigenación del paciente. Aunque muchas de estas condiciones son comunes al resto de las magnitudes del laboratorio, como la identificación correcta del espécimen, algunas son propias del análisis de gases debido a la estabilidad de las magnitudes incluidas en él. Este documento establece recomendaciones para el control de las condiciones preanalíticas y otras fuentes de error relacionadas con el análisis de gases en sangre, tales como las características de los materiales empleados para la toma de muestra (jeringas, agujas y anticoagulantes), tipo de muestra (sangre arterial, venosa y capilar «arterializada») y las condiciones para el manejo y transporte de la muestra, incluyendo la influencia del tiempo transcurrido entre la extracción y el análisis, la temperatura de la muestra durante el transporte y el transporte en sí


Blood gas analysis is a commonly ordered test in different hospital settings. The measurement of the parameters included in this analysis is vulnerable to a huge number of pre-analytical conditions. Laboratory staff are responsible for ensuring that these results accurately reflect the acid-base and oxygenation status of the patient. Despite many pre-analytical steps in blood gas testing being common to other laboratory tests, such as proper sample identification, others are particular for this determination, such as the stability of the analytes measured. The aim of this document is to provide recommendations for the control of the pre-analytical variables and other error sources related to blood gas analysis. These include the characteristics of the materials used to collect the blood samples (syringes, needles and anticoagulants), the sample types (arterial, venous and «arterialised» capillary blood), as well as the conditions for sample handling and transport, including the effect of the time between sampling and analysis, the temperature during transport, and the type of transport

4.
Clin Chem Lab Med ; 57(12): 1829-1836, 2019 Nov 26.
Artigo em Inglês | MEDLINE | ID: mdl-31348756

RESUMO

Stability of a measurand in a specimen is a function of the property variation over time in specific storage conditions, which can be expressed as a stability equation, and is usually simplified to stability limits (SLs). Stability studies show differences or even inconsistent results due to the lack of standardized experimental designs and heterogeneity of the chosen specifications. Although guidelines for the validation of sample collection tubes have been published recently, the measurand stability evaluation is not addressed. This document provides an easy guideline for the development of a stability test protocol based on a two-step process. A preliminary test is proposed to evaluate the stability under laboratory habitual conditions. The loss of stability is assessed by comparing measurement values of two samples obtained from the same patient and analyzed at different time points. One of them is analyzed under optimal conditions (basal sample). The other is stored under specific stability conditions for a time set by the laboratory (test sample). Differences are expressed using percentage deviation (PD%) to facilitate comparison with specifications. When the preliminary test demonstrates instability, a comprehensive test is proposed in order to define the stability equation and to specify SLs. Several samples are collected from a set of patients. The basal sample is analyzed under optimal conditions, whereas analysis of test samples is delayed at time intervals. For each patient PD% is calculated as the difference between measurements for every test sample and its basal one and represented in a coordinate graph versus time.

6.
Diagnosis (Berl) ; 6(1): 39-43, 2019 03 26.
Artigo em Inglês | MEDLINE | ID: mdl-30808159

RESUMO

Transportation of blood samples is a major part of the preanalytical pathway and can be crucial in delaying laboratory results to the clinicians. A variety of aspects however makes sample transportation a complex, challenging and often overlooked task that needs thorough planning and dedicated resources. The purpose of this review is to outline the options available for this task and to emphasize the preanalytical aspects that need consideration in this process, e.g. performance specifications for sample transportation as stated in ISO standards 15189 and 20658, quality control of automated transportation systems, monitoring of sample integrity parameters and temperature surveillance in general and for external samplers in particular. All these are tasks that the laboratory must assure on a daily basis in terms of continuous quality control, and simultaneously the laboratory must remain alert to alterations in clinical demands (sample frequency, turn-around-times) and new regulations within this area (e.g. the recent General Data Protection Regulation from the EU).


Assuntos
Coleta de Amostras Sanguíneas , Fase Pré-Analítica/métodos , Controle de Qualidade , Transportes/métodos , Erros de Diagnóstico , Humanos , Laboratórios
7.
Clin Chem Lab Med ; 56(11): 1806-1818, 2018 10 25.
Artigo em Inglês | MEDLINE | ID: mdl-29729140

RESUMO

BACKGROUND: The stability limit of an analyte in a biological sample can be defined as the time required until a measured property acquires a bias higher than a defined specification. Many studies assessing stability and presenting recommendations of stability limits are available, but differences among them are frequent. The aim of this study was to classify and to grade a set of bibliographic studies on the stability of five common blood measurands and subsequently generate a consensus stability function. METHODS: First, a bibliographic search was made for stability studies for five analytes in blood: alanine aminotransferase (ALT), glucose, phosphorus, potassium and prostate specific antigen (PSA). The quality of every study was evaluated using an in-house grading tool. Second, the different conditions of stability were uniformly defined and the percent deviation (PD%) over time for each analyte and condition were scattered while unifying studies with similar conditions. RESULTS: From the 37 articles considered as valid, up to 130 experiments were evaluated and 629 PD% data were included (106 for ALT, 180 for glucose, 113 for phosphorus, 145 for potassium and 85 for PSA). Consensus stability equations were established for glucose, potassium, phosphorus and PSA, but not for ALT. CONCLUSIONS: Time is the main variable affecting stability in medical laboratory samples. Bibliographic studies differ in recommedations of stability limits mainly because of different specifications for maximum allowable error. Definition of a consensus stability function in specific conditions can help laboratories define stability limits using their own quality specifications.


Assuntos
Coleta de Amostras Sanguíneas/métodos , Alanina Transaminase/sangue , Glicemia/química , Humanos , Fósforo/sangue , Potássio/sangue , Fase Pré-Analítica , Antígeno Prostático Específico/sangue , Estabilidade Proteica , Temperatura Ambiente
8.
Sci Rep ; 7(1): 10100, 2017 08 30.
Artigo em Inglês | MEDLINE | ID: mdl-28855612

RESUMO

Breast cancer is a heterogeneous disease comprising a variety of entities with various genetic backgrounds. Estrogen receptor-positive, human epidermal growth factor receptor 2-negative tumors typically have a favorable outcome; however, some patients eventually relapse, which suggests some heterogeneity within this category. In the present study, we used proteomics and miRNA profiling techniques to characterize a set of 102 either estrogen receptor-positive (ER+)/progesterone receptor-positive (PR+) or triple-negative formalin-fixed, paraffin-embedded breast tumors. Protein expression-based probabilistic graphical models and flux balance analyses revealed that some ER+/PR+ samples had a protein expression profile similar to that of triple-negative samples and had a clinical outcome similar to those with triple-negative disease. This probabilistic graphical model-based classification had prognostic value in patients with luminal A breast cancer. This prognostic information was independent of that provided by standard genomic tests for breast cancer, such as MammaPrint, OncoType Dx and the 8-gene Score.


Assuntos
Neoplasias da Mama/genética , Proteômica , Neoplasias da Mama/classificação , Neoplasias da Mama/patologia , Intervalo Livre de Doença , Feminino , Regulação Neoplásica da Expressão Gênica , Humanos , MicroRNAs/genética , Fenótipo , Prognóstico , Receptores Estrogênicos/genética , Receptores de Progesterona/genética , Neoplasias de Mama Triplo Negativas/genética , Neoplasias de Mama Triplo Negativas/patologia
10.
Clin Chem Lab Med ; 55(4): 530-538, 2017 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-27658151

RESUMO

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.


Assuntos
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
11.
Placenta ; 47: 37-45, 2016 11.
Artigo em Inglês | MEDLINE | ID: mdl-27780538

RESUMO

INTRODUCTION: Oxidative stress is present in pregnancy complications. However, it is unknown if early maternal antioxidant status could influence later development of complications. The use of assisted reproduction techniques (ART) is rising due to the delay of first pregnancy and there is scarce information on its influence on oxidative balance. OBJECTIVE: To assess the possible relationship between maternal plasma antioxidant status in first trimester of gestation with later development of pregnancy complications, evaluating the influence of ART and nutrition. METHODS: Plasma from 98 healthy pregnant women was obtained at week 10, nutrition questionnaires filled and women were followed until delivery. We evaluated biomarkers of oxidative damage (carbonyls, malondialdehyde-MDA), antioxidants (thiols, reduced glutathione, phenolic compounds, catalase and superoxide dismutase activities) by spectrophotometry/fluorimetry and melatonin (ELISA). Antioxidant status score (Antiox-S) was calculated as the computation of antioxidants. Diet-antioxidants relationship was evaluated through multiple correspondence analysis. RESULTS: Melatonin and carbonyls exhibited a negative correlation. No difference in oxidative damage was found between groups, but Antiox-S was significantly lower in women who developed complications. No differences in oxidative damage or Antiox-S were found between ART and no-ART pregnancies. High consumption of foods of vegetable origin cluster with high plasma levels of phenolic compounds and with high Antiox-S. CONCLUSIONS: In early normal gestation, low plasma antioxidant status, assessed through a global score, associates with later development of pregnancy complications. Larger population studies could help to determine the value of Antiox-S as predictive tool and the relevance of nutrition on maternal antioxidant status.


Assuntos
Estresse Oxidativo/fisiologia , Complicações na Gravidez/sangue , Primeiro Trimestre da Gravidez/sangue , Adulto , Biomarcadores/sangue , Catalase/metabolismo , Dieta , Feminino , Glutationa/sangue , Glutationa Peroxidase/metabolismo , Humanos , Malondialdeído/sangue , Melatonina/sangue , Gravidez , Superóxido Dismutase/metabolismo
12.
Clin Chem Lab Med ; 53(12): 1903-10, 2015 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-26053009

RESUMO

The ongoing Ebola virus outbreak in several countries in West Africa was considered by the World Health Organisation (WHO) as a public health emergency of international concern. Healthcare providers must be prepared by organising specific procedures in our hospitals based on recommendations from national and international healthcare organisations. Two aims should be considered: appropriate medical care for patients with suspected or confirmed disease must be ensured, as must measures to prevent transmission to healthcare workers. The clinical laboratory plays an important role and must define and establish its own procedures in accordance with clinicians and integrated into those of the institution, starting with the definition of the organisation model in the laboratory to achieve those goals. In this review we present our experience based on the care of three patients with confirmed cases. We hope it will help other colleagues to plan for Ebola.


Assuntos
Técnicas de Laboratório Clínico , Assistência à Saúde/normas , Doença pelo Vírus Ebola/diagnóstico , Doença pelo Vírus Ebola/terapia , Assistência à Saúde/métodos , Hospitais/normas , Humanos , Espanha
13.
Clin Biochem ; 48(6): 412-8, 2015 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-25562184

RESUMO

INTRODUCTION: Arterial blood gas analysis is relevant in chronic obstructive pulmonary disease (COPD) management. The aim of this study was to evaluate whether the use of a blood gas analyzer in pulmonology departments improves the clinical, operational and economic outcomes when compared with clinical laboratory measurements. PATIENTS AND METHODS: It is an observational prospective study. 112 patients were selected. After specimen collection, the measurement was performed both in pulmonology office as point-of-care and in laboratory. We evaluated clinical outcomes (modification of the indication of long-term oxygen therapy (LTOT) according to results, changes in blood gas analysis results, relationship of the partial pressure of oxygen (PaO2) obtained in the medical visit and velocity of change of the PaO2, influence of total haemoglobin concentration and the change in PaO2), operational outcomes (turnaround time (TAT) from specimen collection to receiving the blood gas analysis report) and economic outcomes (overall cost per process of patient care). RESULTS: There were discrepancies in the indication of LTOT in 13.4% of patients. All parameters showed changes. PaO2 levels showed changes in 2 ways, though they frequently increase over time. The correlation was not good in the other two clinical outcomes. The median TATs in pulmonology office were 1 min versus 79 in laboratory, with 52 min for specimen preparation and transport and 17 min for TAT intralaboratory. The overall cost for the 112 patients in pulmonology office and laboratory was 16,769.89€ and 22,260.97€ respectively. CONCLUSIONS: The use of a blood gas analyzer in a pulmonology office improves clinical, operational and economic outcomes when compared with clinical laboratory.


Assuntos
Doença Pulmonar Obstrutiva Crônica/sangue , Adulto , Idoso , Idoso de 80 Anos ou mais , Análise Química do Sangue/economia , Feminino , Custos de Cuidados de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Oxigenoterapia/economia , Sistemas Automatizados de Assistência Junto ao Leito , Estudos Prospectivos , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Doença Pulmonar Obstrutiva Crônica/economia , Doença Pulmonar Obstrutiva Crônica/terapia , Resultado do Tratamento
14.
PLoS One ; 9(12): e112858, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-25546056

RESUMO

INTRODUCTION: The present study describes the distribution of selected micronutrients and anaemia among school-aged children living in Libo Kemkem and Fogera (Amhara State, Ethiopia), assessing differences by socio-demographic characteristics, health status and dietary habits. METHODS: A cross-sectional survey was carried out during May-December 2009. Socio-demographic characteristics, health status and dietary habits were collected. Biomarkers were determined for 764 children. Bivariate and multivariable statistical methods were employed to assess micronutrient deficiencies (MD), anaemia, and their association with different factors. RESULTS: More than two thirds of the school-aged children (79.5%) had at least one MD and 40.5% had two or more coexisting micronutrient deficiencies. The most prevalent deficiencies were of zinc (12.5%), folate (13.9%), vit A (29.3%) and vit D (49%). Anaemia occurred in 30.9% of the children. Children living in rural areas were more likely to have vit D insufficiency [OR: 5.9 (3.7-9.5)] but less likely to have folate deficiency [OR: 0.2 (0.1-0.4)] and anaemia [OR: 0.58 (0.35-0.97)]. Splenomegaly was positively associated with folate deficiency and anaemia [OR: 2.77 (1.19-6.48) and 4.91 (2.47-9.75)]. Meat and fish consumption were inversely correlated with zinc and ferritin deficiencies [OR: 0.2 (0.1-0.8) and 0.2 (0.1-0.9)], while oil consumption showed a negative association with anaemia and deficiencies of folate and vitamin A [0.58 (0.3-0.9), OR: 0.5 (0.3-0.9) and 0.6 (0.4-0.9)]. Serum ferritin levels were inversely correlated to the presence of anaemia (p<0.005). CONCLUSION: There is a high prevalence of vitamin A deficiency and vitamin D insufficiency and a moderate prevalence of zinc and folate deficiencies in school-aged children in this area. The inverse association of anaemia and serum ferritin levels may be due to the presence of infectious diseases in the area. To effectively tackle malnutrition, strategies should target not only isolated micronutrient supplementation but also diet diversification.


Assuntos
Transtornos da Nutrição Infantil/epidemiologia , Micronutrientes/deficiência , Adolescente , Anemia/epidemiologia , Criança , Pré-Escolar , Estudos Transversais , Etiópia , Feminino , Deficiência de Ácido Fólico/epidemiologia , Humanos , Masculino , Deficiência de Vitamina A/epidemiologia , Deficiência de Vitamina D/epidemiologia , Zinco/deficiência
15.
Rev. lab. clín ; 7(4): 134-140, oct.-dic. 2014.
Artigo em Espanhol | IBECS | ID: ibc-130200

RESUMO

El actual brote de enfermedad por el virus del Ébola en África Occidental fue considerado por la Organización Mundial de la Salud como una alerta sanitaria que constituye una urgencia de salud pública de importancia internacional. Los profesionales sanitarios debemos estar preparados estableciendo en nuestros hospitales procedimientos y protocolos de actuación basados en recomendaciones de instituciones sanitarias nacionales e internacionales con dos objetivos, garantizar la atención y manejo de pacientes con sospecha o confirmación de la enfermedad y la seguridad y salud de los trabajadores. El laboratorio clínico desempeña un papel fundamental y como tal ha de definir y establecer procedimientos específicos consensuados con los clínicos e integrados en los del propio centro, definiendo en primer lugar el modelo de organización que permita conseguir ambos objetivos. En esta revisión exponemos además nuestra experiencia basada en la atención a un paciente con la enfermedad confirmada que esperamos pueda servir de ayuda a otros centros (AU)


The ongoing Ebola virus outbreak in several countries in West Africa was considered by the World Health Organization as a public health emergency of international concern. Healthcare providers must be prepared in our hospitals by organizing specific procedures based on recommendations from national and international healthcare organizations. Two aims should be considered, appropriate medical care for patients with suspected or confirmed disease must be assured, as well as measures to prevent transmission to health-care workers. The clinical laboratory plays an important role and must define and establish its own procedures in agreement with clinicians and integrated into those of the institution, starting with the definition of the organization model in the laboratory to achieve those goals. Our experience based on the care of a patient with a confirmed case is presented, and it is hoped that it will help other colleagues to plan for Ebola (AU)


Assuntos
Humanos , Masculino , Feminino , Doença pelo Vírus Ebola/sangue , Doença pelo Vírus Ebola/diagnóstico , Ebolavirus , Ebolavirus/isolamento & purificação , Ebolavirus/patogenicidade , Testes Laboratoriais/métodos , Diagnóstico Precoce , Anticorpos Monoclonais , Técnicas de Laboratório Clínico/métodos , Técnicas de Laboratório Clínico , Saúde Pública/métodos , Doença pelo Vírus Ebola/transmissão , Cuidados Paliativos/métodos , Centers for Disease Control and Prevention (U.S.)/organização & administração , Centers for Disease Control and Prevention (U.S.)/normas , Prevenção e Mitigação/prevenção & controle
17.
Clin Chem Lab Med ; 51(9): 1739-46, 2013 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-23612663

RESUMO

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.


Assuntos
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
18.
Biochem Med (Zagreb) ; 23(1): 83-95, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-23457769

RESUMO

INTRODUCTION: Technological innovation requires the laboratories to ensure that modifications or incorporations of new techniques do not alter the quality of their results. In an ISO 15189 accredited laboratory, flexible scope accreditation facilitates the inclusion of these changes prior to accreditation body evaluation. A strategy to perform the validation of a biochemistry analyzer in an accredited laboratory having a flexible scope is shown. MATERIALS AND METHODS: A validation procedure including the evaluation of imprecision and bias of two Dimension Vista analysers 1500 was conducted. Comparability of patient results between one of them and the lately replaced Dimension RxL Max was evaluated. All studies followed the respective Clinical and Laboratory Standards Institute (CLSI) protocols. 30 chemistry assays were studied. Coefficients of variation, percent bias and total error were calculated for all tests and biological variation was considered as acceptance criteria. Quality control material and patient samples were used as test materials. Interchangeability of the results was established by processing forty patients' samples in both devices. RESULTS: 27 of the 30 studied parameters met allowable performance criteria. Sodium, chloride and magnesium did not fulfil acceptance criteria. Evidence of interchangeability of patient results was obtained for all parameters except magnesium, NT-proBNP, cTroponin I and C-reactive protein. CONCLUSIONS: A laboratory having a well structured and documented validation procedure can opt to get a flexible scope of accreditation. In addition, performing these activities prior to use on patient samples may evidence technical issues which must be corrected to minimize their impact on patient results.


Assuntos
Acreditação/normas , Invenções/normas , Laboratórios Hospitalares/normas , Biomarcadores/sangue , Humanos , Controle de Qualidade , Centros de Atenção Terciária , Estudos de Validação como Assunto
19.
Rev. lab. clín ; 4(4): 196-200, oct.-dic. 2011.
Artigo em Espanhol | IBECS | ID: ibc-91590

RESUMO

Introducción. En las Unidades de Extracción, cada vez es mayor el número de pacientes portadores de un catéter reservorio vascular subcutáneo (CRVS) que solicitan su utilización para la extracción de muestras para análisis, sustituyendo la venopunción convencional. El objetivo de este estudio fue evaluar si la obtención de la muestra de sangre a través de CRVS, a pesar de la utilización de un procedimiento de extracción específico, modifica los resultados de las pruebas de coagulación básicas. Material y métodos. Se estudiaron 10 pacientes que acudieron a la Unidad de Extracciones de nuestro hospital, atendidos de forma consecutiva por dos extractores experimentados. En cada paciente se obtuvieron 2 muestras de sangre, una mediante venopunción periférica y otra a través de CRVS, comparándose los resultados de las pruebas de coagulación (tiempo de protrombina-TP y fibrinógeno derivado, tiempo de tromboplastina parcial activado-TTPA y D-dímero). Resultados. En el caso del TTPA, se observaron diferencias estadística y clínicamente significativas entre las muestras obtenidas mediante venopunción y las obtenidas por el CRVS: las medias de los valores fueron 24,9s y 27,9s, respectivamente (p<0,05). No se encontraron diferencias estadísticamente significativas en el caso de TP, fibrinógeno y D-dímero. Conclusiones. La diferencia observada en los resultados para el TTPA entre las muestras obtenidas desde CRVS comparada con la extracción venosa periférica sugiere la recomendación, en estos casos, de efectuar venopunción periférica. El uso del dispositivo CRVS resulta cómodo para el paciente, pero no es recomendable en todos los casos ya que puede ser motivo de errores de laboratorio (AU)


Introduction. The number of patients with Implantable Venous-Access Port Systems (IVAPS) seen in Phlebotomy Outpatients, as well as requests for drawing blood samples through this system instead of conventional venepuncture, are continuously increasing. The aim of this study was to assess if drawing blood samples through IVAPS, despite using a specific procedure, may alter results of basic blood coagulation tests. Material and methods. We studied 10 patients with IVAPS, who came to Phlebotomy Outpatients at our hospital, and who were attended to by two nurses with experience in handling these devices. Two samples were obtained from each patient, one of them drawn through IVAPS, and the other by peripheral venepuncture, and the results for blood coagulation tests (Prothrombin Time-PT, PT derived Fibrinogen, Activated Partial Thromboplastin Time-APTT and D-Dimer) were evaluated. Results. Statistically and clinically significant differences were found, for APTT, between IVAPS and venepuncture: mean values were, respectively, 24.9s and 27.9s (P<.05). No other results (PT, PT derived Fibrinogen or D-Dimer) showed statistically significant differences. Conclusions. The difference observed in APTT results between samples drawn through IVAPS compared to samples obtained by venepuncture, suggests that peripheral venepuncture should be used in these patients. The use of IVAPS is convenient for the patient, but it is not always recommended, as it may lead to laboratory errors (AU)


Assuntos
Humanos , Masculino , Feminino , Testes de Coagulação Sanguínea/métodos , Testes de Coagulação Sanguínea/tendências , Testes de Coagulação Sanguínea , /métodos , Cateteres , Testes de Coagulação Sanguínea/instrumentação , Biópsia por Agulha Fina/métodos , Biópsia por Agulha Fina/tendências
20.
Rev. lab. clín ; 3(4): 177-182, oct.-dic. 2010. tab
Artigo em Espanhol | IBECS | ID: ibc-85211

RESUMO

Introducción. La detección y comunicación de valores críticos es una de las funciones del laboratorio que más repercusión tiene sobre la seguridad del paciente. La Comisión de la Calidad Extraanalítica de la SECQ ha realizado unas encuestas para conocer la situación de los laboratorios españoles. Material y métodos. Se enviaron dos encuestas a 728 laboratorios participantes en el Programa de Garantía Externa de la Calidad de Bioquímica suero, para conocer diferentes aspectos relacionados con la comunicación de los mismos y el límite establecido para diferentes magnitudes, diferenciando entre consulta externa y hospitalización. Resultados. La mayoría de los laboratorios encuestados tienen definidos valores críticos (81,5 %) y es el facultativo del laboratorio quien los notifica (87,3 %) telefónicamente (91,1 %) al médico responsable del paciente (86,6 %). Un 58 % de laboratorios comprueba que el aviso se ha recibido, un 54,8 % no ha definido el plazo de entrega y el 87,9 % no utiliza un indicador para controlar este proceso. Resultados. Las medianas obtenidas para la mayoría de constituyentes no difieren según el origen de los pacientes, siendo parecidas para consulta externa y hospitalización. Sin embargo, se encuentran diferencias en el nivel bajo del calcio y en el nivel alto de la creatinina, la glucosa y la urea. Conclusiones. Se observa una falta de estandarización y consenso en el tratamiento de estos valores. Debido a que su detección implica una actuación médica urgente, consideramos necesario que los laboratorios en colaboración con los clínicos desarrollen estrategias adecuadas para el establecimiento y notificación de estos valores (AU)


Introduction. Detection and reporting of critical values have great implications on patient safety. The SEQC Committee for the extra-analytical quality assessment has carried out a survey in order to evaluate these in Spanish laboratories. Material and methods. Two surveys were distributed among 728 participants registered in the External Quality Assessment Scheme (clinical chemistry, serum). Participants were asked to provide information regarding reporting of critical values and their decision limits. Outpatient and in-patient reporting were considered separately. Results. Most laboratories (81.5 %) had their critical values already defined; physicians assumed the responsibility of notifying critical results in 87.3 % of cases; critical results were mainly informed by telephone (91.1 %); 58 % of laboratories further verified that such notifications were received; delivery time was not taken into account in 54.8 % of laboratories; 87.9 % did not employ any indicator to track this process. Results. Median values obtained for most constituents did not differ and were similar for outpatient and hospital settings. Nevertheless, differences were found for the lower calcium critical value and for high critical values for creatinine, glucose and urea. Conclusions. Handling of critical values lacks standardization and a consensus among Spanish laboratories. Suitable strategies should be developed between laboratories and clinicians in order to correctly define and set up critical values, as their detection requires urgent medical action (AU)


Assuntos
Humanos , Masculino , Feminino , Análise de Perigos e Pontos Críticos de Controle , /normas , Controle de Qualidade , Enquete Socioeconômica , Bioquímica/organização & administração , Bioquímica/estatística & dados numéricos , Bioquímica/normas
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