La Sociedad Española de Medicina de Laboratorio (SEQC-ML) ante la recertificación profesional / The Spanish Society of Laboratory Medicine (SEQC-ML) before professional recertification

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Assessment of patient safety culture in clinical laboratories in the Spanish National Health System.

INTRODUCTION: There is increasing awareness of the importance of transforming organisational culture in order to raise safety standards. This paper describes the results obtained from an evaluation of patient safety culture in a sample of clinical laboratories in public hospitals in the Spanish National Health System. MATERIAL AND METHODS: A descriptive cross-sectional study was conducted among health workers employed in the clinical laboratories of 27 public hospitals in 2012. The participants were recruited by the heads of service at each of the participating centers. Stratified analyses were performed to assess the mean score, standardized to a base of 100, of the six survey factors, together with the overall patient safety score. RESULTS: 740 completed questionnaires were received (88% of the 840 issued). The highest standardized scores were obtained in Area 1 (individual, social and cultural) with a mean value of 77 (95%CI: 76-78), and the lowest ones, in Area 3 (equipment and resources), with a mean value of 58 (95%CI: 57-59). In all areas, a greater perception of patient safety was reported by the heads of service than by other staff. CONCLUSIONS: We present the first multicentre study to evaluate the culture of clinical safety in public hospital laboratories in Spain. The results obtained evidence a culture in which high regard is paid to safety, probably due to the pattern of continuous quality improvement. Nevertheless, much remains to be done, as reflected by the weaknesses detected, which identify areas and strategies for improvement.

Pre-analytical errors management in the clinical laboratory: a five-year study.

INTRODUCTION: This study describes quality indicators for the pre-analytical process, grouping errors according to patient risk as critical or major, and assesses their evaluation over a five-year period. MATERIALS AND METHODS: A descriptive study was made of the temporal evolution of quality indicators, with a study population of 751,441 analytical requests made during the period 2007-2011. The Runs Test for randomness was calculated to assess changes in the trend of the series, and the degree of control over the process was estimated by the Six Sigma scale. RESULTS: The overall rate of critical pre-analytical errors was 0.047%, with a Six Sigma value of 4.9. The total rate of sampling errors in the study period was 13.54% (P = 0.003). The highest rates were found for the indicators "haemolysed sample" (8.76%), "urine sample not submitted" (1.66%) and "clotted sample" (1.41%), with Six Sigma values of 3.7, 3.7 and 2.9, respectively. CONCLUSION: The magnitude of pre-analytical errors was accurately valued. While processes that triggered critical errors are well controlled, the results obtained for those regarding specimen collection are borderline unacceptable; this is particularly so for the indicator "haemolysed sample".

[Validation of a questionnaire to evaluate patient safety in clinical laboratories]. / Validación de un cuestionario para evaluar la seguridad del paciente en los laboratorios clínicos.

OBJECTIVES: The aim of this study was to prepare, pilot and validate a questionnaire to evaluate patient safety in the specific context of clinical laboratories. METHODS: A specific questionnaire on patient safety in the laboratory, with 62 items grouped into six areas, was developed, taking into consideration the diverse human and laboratory contextual factors which may contribute to producing errors. A pilot study of 30 interviews was carried out, including validity and reliability analyses using principal components factor analysis and Cronbach's alpha. Subsequently, 240 questionnaires were sent to 21 hospitals, followed by a test-retest of 41 questionnaires with the definitive version. RESULTS: The sample analyzed was composed of 225 questionnaires (an overall response rate of 80%). Of the 62 items initially assessed, 17 were eliminated due to non-compliance with the criteria established before the principal components factor analysis was performed. For the 45 remaining items, 12 components were identified, with an cumulative variance of 69.5%. In seven of the 10 components with two or more items, Cronbach's alpha was higher than 0.7. The questionnaire items assessed in the test-retest were found to be stable. CONCLUSIONS: We present the first questionnaire with sufficiently proven validity and reliability for evaluating patient safety in the specific context of clinical laboratories. This questionnaire provides a useful instrument to perform a subsequent macrostudy of hospital clinical laboratories in Spain. The questionnaire can also be used to monitor and promote commitment to patient safety within the search for continuous quality improvement.

Aplicación del análisis modal de fallos y sus efectos a la fase preanalítica de un laboratorio clínico / Application of failure mode and effects analysis of the pre-analytical phase in a clinical laboratory

Introducción. La seguridad es una condición dinámica y debe ser la filosofía que sustente la mejora de la calidad en el ámbito sanitario. Las estrategias para reducir incidentes pasan por abordarlos desde un enfoque general para soluciones generales a largo plazo, admitir que los errores se producen (cultura), se notifican (sacan a la luz), y se analizan los factores causales, todo ello desde una actitud proactiva, preventiva y sistemática. Material y método. El Laboratorio Clínico del Hospital de Antequera propuso en el año 2006 realizar un análisis descriptivo modal de su fase preanalítica, proceso de alto riesgo para la seguridad del paciente, en el que se genera el mayor porcentaje de errores y dónde intervienen un importante número de profesionales, la mayoría ajenos al laboratorio cuya contribución al resultado final es decisivo; aplicando el análisis modal de fallos y sus efectos (AMFE). Resultados. En función del número de prioridad de riesgo, se propusieron acciones de mejora, rediseñaron procesos, se realizaron procedimientos e instrucciones y se implementaron indicadores para medir resultados en el tiempo y evaluar las actuaciones para una mejora continua. Conclusiones. Lo importante, al hablar de seguridad en los laboratorios, es la fiabilidad en cuanto a ausencia de errores, y la utilidad de la información que generamos. En este sentido, el AMFE resulta ser una fuente de información importante para detectar fallos activos y los latentes del sistema. Además, la participación y difusión de este tipo de trabajos fomenta el compromiso y la responsabilidad de los profesionales en la seguridad (AU)

Introduction. Safety dynamics should be the philosophy that supports improved quality in the healthcare environment. Strategies to reduce incidents have been undertaken for long-term solutions, to identify that errors occur (culture) are highlighted and the causal factors are pro-actively, preventively and systematically analysed. Material and methods. In 2006 the Clinical Laboratory of Antequera Hospital proposed to carry out a descriptive analytical model to address the risk assessment for the safety of the high-risk patient, as this is the group in which the majority of errors is generated and study how this affects the professionals working in the laboratory, whose contribution to the final results is decisive, by applying the failure mode and effect analysis (FMEA). Results. Considering the number of risk priorities, improvement actions were proposed, processes re-designed and indicators, procedures and instructions were implemented to measure the results in order to evaluate and establish methods for continuous improvement within the laboratory. Conclusions. When looking at safety in the laboratory, the most important factors are the absence of adverse events (errors), reliability of the methods and the use of the information generated. As a result, the FMAE's findings are an important source of information in detecting active and latent failures of the system. In addition, the participation and dissemination of this type of knowledge promotes the commitment and responsibility of the professionals in safety issues (AU)