[Management of Personal Information in Clinical Laboratory Medicine:--Chairmen's Introductory Remarks].

The Japanese Society of Laboratory Medicine has been running its own Medical Safety Committee, and holding a symposium on medical safety during the annual meeting. The medical world is filled with a considerable amount of personal information, including genetic information, the ultimate personal information. We, as medical staff, have to manage such personal information not only in times of peace but also during disasters or emergency situations. In Japan, the Act on the Protection of Personal Information is currently being implemented, but a number of problems remain. Human beings have entered the information technology era, including electrical medical record systems, which is useful for research and education besides medical practice. This is why personal information must be more effectively protected from leakage, misconception, and abuse. We should create a sound system to manage personal information, with the spirit of protecting patient information that originated from the Oath of Hippocrates.

[Security Management in Clinical Laboratory Departments and Facilities: Current Status and Issues].

We conducted a questionnaire survey regarding the current activities for protecting patients' privacy and the security of information systems (IS) related to the clinical laboratory departments of university hospitals, certified training facilities for clinical laboratories, and general hospitals in Yamaguchi Prefecture. The response rate was 47% from 215 medical institutions, including three commercial clinical laboratory centers. The results showed that there were some differences in management activities among facilities with respect to continuing education, the documentation or regulation of operational management for paper records, electronic information, remaining samples, genetic testing, and laboratory information for secondary use. They were suggested to be caused by differences in functions between university and general hospitals, differences in the scale of hospitals, or whether or not hospitals have received accreditation or ISO 15189. Regarding the IS, although the majority of facilities had sufficiently employed the access control to IS, there was some room for improvement in the management of special cases such as VIPs and patients with HIV infection. Furthermore, there were issues regarding the login method for computers shared by multiple staff, the showing of the names of personnel in charge of reports, and the risks associated with direct connections to systems and the Internet and the use of portable media such as USB memory sticks. These results indicated that further efforts are necessary for each facility to continue self-assessment and make improvements.

Studies on the variation in clinical laboratory data and safety evaluation of pharmaceuticals.

The safety of pharmaceuticals has become increasingly important not only in daily medical treatment but also in clinical trials. Although clinical laboratory data are more objective than clinical symptoms, the determination as to whether they indicate abnormal variations depends largely upon the clinical judgment of physicians. The process of determination has not been sufficiently objectified. The present study investigated the indices of criteria for variations in clinical laboratory data obtained in clinical trials. Then, detection rates of abnormal variations were compared between our determination method that employs the reference change value (RCV) expressing the width of biological variation for each test component and conventional determination methods. The study also demonstrated that by combining standard values and the RCV for determination, abnormal variations were found at a rate greater than 50%. The method we propose was applied to the safety evaluation of pharmaceuticals. In clinical trials on the antiviral drug ribavirin administered alone, components of laboratory tests were selected that should be noted in studies on its effects. Expect for decreases in red blood cell counts and hemoglobin values, which are closely associated with anemic symptoms and well known to hepatologists, the increasing trend in platelet counts and decreasing trend in albumin were found to be laboratory test components that should be paid attention to, even though they may not be obvious.

La gestión por procesos en el laboratorio clínico como herramienta para disminuir los errores preanalíticos / Process management in the clinical laboratory as a tool to reduce pre-analytical errors

Introducción. El propósito de este estudio fue medir la efectividad de las actuaciones asociadas a la implantación del «Proceso de soporte Laboratorios Clínicos» como herramienta para disminuir los errores preanalíticos en el Hospital Infanta Margarita y su área. Métodos. Para ello, entre 2007 y 2010, se realizó un estudio cuasiexperimental con intervención comunitaria y evaluación antes y después de la misma, en el área hospitalaria del laboratorio del Hospital Infanta Margarita, utilizando como variable predictora la implantación del proceso y como variables resultado, los indicadores de errores preanalíticos. En el análisis estadístico se compararon los valores obtenidos antes y después de la intervención, mediante el cálculo del valor de los estadísticos X2, riesgo relativo y fracción preventiva. Resultados. Tras la implantación del proceso disminuyeron los errores en los datos demográficos del paciente (85,7 vs. 29,2%; p<0,001), los de identificación del episodio (13,9 vs. 4,9%; p<0,001), la omisión del identificador unívoco de historia sanitaria en Atención Primaria (99,9 vs. 24,4%; p<0,001) y Especializada (99,9 vs. 14,5%; p<0,001), las muestras no procesables (4,04 vs. 1,42%; p<0,001) y la hemólisis (5,76 vs. 3,55%; p<0,001). La omisión del diagnóstico no mejoró (82,3 vs. 81,7%). Conclusiones. La implantación del proceso de laboratorio se reveló como una herramienta muy eficaz para la disminución de los errores preanalíticos (AU)

Introduction. The purpose of this study was to measure the effectiveness of the activities associated with the implementation of the "Clinical Laboratories Process Support" as a tool to reduce pre-analytical errors in the Hospital Infanta Margarita and its area. Material and methods. A quasi-experimental study was conducted between 2007 and 2010, with before and after community intervention and evaluation, in the Hospital Infanta Margarita catchment area, using the implementation of the process as a predictive variable and indicators of pre-analytical errors as outcome variables. The values obtained before and after the intervention were compared by statistical analysis, with the statistical value of X2, relative risk and preventive fraction being calculated. Results. Errors in patient demographics decreased after the introduction of the process(85.7% vs. 29.2%, p<.001), identification of the episode (13.9% vs. 4.9%, p<.001), the omission of the Primary Care (99.9% vs. 24.4%, p<.001) or Hospital Care medical record unique identifiers (99.1% vs. 14.7%, p<.001), samples unsuitable for analysis (4.04% vs. 1.42%, p<0.001) and haemolysis (5.76% vs. 3.55%, p<.001). Failure to give the diagnosis did not improve (82.3% vs. 81.7%). Conclusions. The implementation of the laboratory process emerged as a powerful tool for reducing pre-analytical errors (AU)

Actuación del laboratorio ante la obtención de valores críticos / Laboratory action on obtaining critical values

En el laboratorio clínico se obtienen los resultados de los estudios solicitados a los pacientes. Los informes de estos resultados se entregan habitualmente al paciente o a su médico, en papel o mediante sistemas informáticos, en los plazos de respuesta establecidos de acuerdo con el resto del equipo asistencial y siguiendo las normas de la institución. En algunas ocasiones, los resultados obtenidos no permiten agotar esos tiempos de respuesta, sino que su trascendencia para la situación del paciente requiere la comunicación urgente al personal sanitario a cuyo cargo se encuentre. En estos casos, todo el personal con responsabilidad en el laboratorio debe conocer cómo detectar uno de estos valores críticos y cómo actuar cuando lo encuentre. Se revisan los conceptos y la normativa correspondiente y se recomiendan procedimientos para la detección, la notificación y la documentación de valores críticos (AU)

The clinical laboratory performs the tests requested on patients. The laboratory reports these results to patients or their medical doctors in paper or electronic form, within the established response time and under the institutional regulations. Occasionally, the importance of the data obtained, forces to immediate communication with the health personnel in charge. All laboratory staff must know how to detect and inform these critical values. We have reviewed regulations and common concepts, such as detection, reporting and documentation procedures of the critical values in clinical laboratory (AU)

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)

Comunicación urgente del laboratorio de anemias potencialmente graves en pacientes ambulatorios / Urgent laboratory notifications on potential serious anemias in outpatients

Introducción. La notificación urgente al clínico del diagnóstico de laboratorio de anemias potencialmente graves en pacientes ambulatorios puede influir en la decisión de derivación de estos pacientes a los servicios de urgencias. Material y métodos. Mediante un protocolo basado en pruebas de laboratorio de hematología y bioquímica habitual, se procedió al diagnóstico en el mismo día de la extracción de la muestra de todas las anemias con hemoglobina (Hb) inferior a 80g/l durante un año. En el mismo día se informó al clínico del diagnóstico de la anemia y del valor de la Hb (grupo de estudio) o únicamente del valor de la Hb (grupo control). Resultados. Se envió a urgencias a 18 de 89 pacientes del grupo de estudio (20%) y a 42 de 91 pacientes del grupo control (46%) (p=0,0003). Los pacientes enviados a urgencias del grupo de estudio tenían una Hb de 69±1,1g/l y los del grupo control de 60±1,0g/l (p<0,001). Conclusiones. La comunicación urgente al clínico del diagnóstico de laboratorio de anemias potencialmente graves facilita la adecuada derivación a urgencias de los pacientes ambulatorios en comparación con la comunicación aislada del valor de la Hb (AU)

Introduction. Urgent notification to clinicians of the laboratory diagnosis of potentially serious anaemias in outpatients may influence the decision to refer these patients to emergency units. Material and methods. Using a protocol based on routine haematology and biochemical lab analyses, we made, on the same day the sample was obtained, the diagnosis of any anaemia with a Hb<80g/L, over one year. The clinician was informed of the anaemia diagnosis and the Hb value on the same day (study group) or the Hb value only (control group). Results. A total of 18 of the 89 (20%) patients in the study group and 42 of the 91 (46%) patients in the control group were referred to emergency units (P=0.0003). Patients from the study group who were sent to emergency units had a Hb of 69±1.1g/L, while those of the control group had a Hb of 60±1.0g/L (P<0.001). Conclusions. Urgently notifying the clinician of the laboratory diagnosis of potentially serious anaemias makes referrals of outpatients to emergency units easier compared to the communication of the Hb value only (AU)

Variación biológica. Revisión desde una perspectiva práctica / Biological variation. A review from a practical perspective

Los autores realizan una revisión exhaustiva sobre la variación biológica, con el objeto de resaltar su aplicación práctica en la rutina diaria del laboratorio clínico. Se describe brevemente el método de estimación de los componentes de la variación biológica y se detalla la base de datos actualizada bianualmente y disponible para los profesionales del sector. Se pormenoriza el uso práctico en el control interno del proceso analítico, en la evaluación de los datos del control interno y externo, así como en la detección de errores analíticos y extraanalíticos. Finalmente, se explica con claridad cómo notificar la posibilidad de un cambio significativo en el estado de salud del paciente en el informe analítico (AU)

This is an exhaustive review on biological variation, which aims to highlight its practical application in daily routine of clinical laboratories. The methodology to estimate the components of biological variation is summarised and a database, which is updated every two years and available to professionals of the area, is explained in detail. Daily application of data derived from biological variation in daily practice in internal and external quality control, as well as, in the detection of analytical and non-analytical errors is clearly explained. Last, but not least, examples are given on how to notify to clinicians on possible changes in patients health status (AU)