Parte III. Apoyo del laboratorio de microbiología y anatomía patológica en el diagnóstico y manejo de infecciones en el paciente con cáncer y trasplante de precursores hematopoyéticos / Support of the laboratory of microbiology and pathological anatomy in the diagnosis and management of infections in cancer patients and transplantation of hematopoietic stem cell transplant receptors

Resumen El enfrentamiento del diagnóstico diferencial y etiológico de las enfermedades infecciosas de los pacientes con cáncer, incluyendo los receptores de trasplante de precursores hematopoyéticos (TPH), debe corresponder a una decisión informada, oportuna y que repercuta directamente en una conducta médica que determine una mejor sobrevida y calidad de vida de los pacientes. El objetivo de este trabajo fue aportar en el manejo de estos pacientes desarrollando una herramienta útil al médico clínico para tomar estas decisiones. Para ello se agruparon las infecciones por sistemas comprometidos diferenciando los posibles agentes etiológicos en bacterias, virus, hongos y parásitos, explicitando los exámenes diagnósticos más relevantes, mencionando la o las técnicas recomendadas, junto con el tipo de muestra óptima para su adecuado procesamiento. De manera adicional, se incorporó el ítem "nivel de requerimiento" para sugerir lo que, a juicio de los autores y la evidencia existente, debe estar presente obligatoriamente en el centro o puede ser derivable a otro laboratorio.

The confrontation of the differential and etiological diagnosis of the infectious diseases of cancer patients, including hematopoietic stem cells transplant (HSCT) recipients, must correspond to an informed, timely decision that directly affects medical behavior that determines a better survival and quality of life for patients. The main goal of this work was to contribute to the management of these patients developing a useful tool for the clinician to make these decisions. For that, infections were grouped by compromised systems, differentiating the possible etiological agents in bacteria, viruses, fungi and parasites, highlighting the relevant diagnostic tests, mentioning the recommended techniques together with the optimal sample type for proper processing. In addition, under each group of techniques we added the item "level of requirement" to suggest what, in the opinion of the authors and the existing evidence, must be mandatory to have at local level or can be derivable to another laboratory.

Clinical Pharmacogenetic Testing and Application: Laboratory Medicine Clinical Practice Guidelines

Pharmacogenetic testing for clinical applications is steadily increasing. Correct and adequate use of pharmacogenetic tests is important to reduce unnecessary medical costs and adverse patient outcomes. This document contains recommended pharmacogenetic testing guidelines for clinical application, interpretation, and result reporting through a literature review and evidence-based expert opinions for the clinical pharmacogenetic testing covered by public medical insurance in Korea. This document aims to improve the utility of pharmacogenetic testing in routine clinical settings.

Development of a Novel Quality Improvement Indicator Based on the Hemolysis Index

Hemolysis frequently causes preanalytical errors in laboratory measurements. We aimed to develop a quality improvement indicator for evaluating the extent of inappropriate procedures causing hemolysis in clinical samples collected in medical care units. We defined the threshold value of the hemolysis index (H index) causing significant interference with analyte measurement and analyzed the H index values of clinical samples in relation to the threshold. The H index threshold value causing a 10% bias in the measurement of lactate dehydrogenase was found to be 25. The monthly mean H index and monthly frequency of samples with an H index >25 were significantly different among the types of ward (P=0.001, respectively), and significantly decreased after replacement of a laboratory centrifuge lacking temperature control (20.6±0.58 vs 23.30±1.08, P=0.01; 23.4±1.69% vs 32.6±1.78%, P=0.01). The monthly mean H index and the monthly frequency of samples with an H index above a threshold value may be useful quality improvement indicators for detection of inappropriate procedures in the acquisition and handling of blood samples in medical care units.

Tendencias de la resistencia a antibióticos en Medellín y en los municipios del área metropolitana entre 2007 y 2012: resultados de seis años de vigilancia / Trends in antibiotic resistance in Medellín and municipalities of the Metropolitan Area between 2007 and 2012: Results of six years of surveillance

Introducción. La resistencia bacteriana es un fenómeno mundial, pero su comportamiento varía en el tiempo y el espacio, confiriéndole importancia a los sistemas de vigilancia locales. Objetivo. Determinar las tendencias de la resistencia a antibióticos entre 2007 y 2012 en instituciones hospitalarias de Medellín y del Área Metropolitana del Valle de Aburrá. Materiales y métodos. Entre 2007 y 2012 se obtuvieron los porcentajes de resistencia a antibióticos marcadores en 22 instituciones, utilizando el programa Whonet 5.6. Se empleó la guía del Clinical and Laboratory Standards Institute (CLSI) de los años 2009 y 2012 para interpretar los resultados de las pruebas de sensibilidad. Con el programa Epi-Info 6.04 se analizaron tendencias por medio de la prueba de ji al cuadrado de tendencia lineal con un nivel de confianza de 95 %; se consideró significativo un valor de p=0,05. Resultados. Se observó una disminución de la resistencia a oxacilina en S taphylococcus aureus (p=0,0006) y un incremento de la resistencia a vancomicina en Enterococcus faecium (p=0,0000). En Escherichia coli y Serratia marcescens se observó un incremento de la resistencia a ceftazidima, en contraste con una disminución en Klebsiella pneumoniae (p=0,0000) y Enterobacter cloacae (p=0,058). Para K. pneumoniae, S. marcescens y E. cloacae se observó un incremento de la resistencia a carbapenémicos, en contraste con una disminución en Pseudomonas aeruginosa y Acinetobacter baumannii. Conclusiones. La vigilancia de la resistencia permitió obtener hallazgos importantes como la emergencia de E. faecium resistente a la vancomicina y enterobacterias resistentes a los carbapenémicos. Es indispensable conocer el uso de antibióticos en la región para establecer su influencia en los perfiles encontrados, además de garantizar la calidad de la información emanada de los laboratorios de microbiología.

Introduction: Bacterial resistance is a global phenomenon, but it presents geographic and temporal variations; this is the importance of local surveillance programs. Objective: To determine trends in antibiotic resistance in hospitals between 2007 and 2012 in Medellín and its Metropolitan Area. Materials and methods: Percentages of antibiotic resistance between 2007 and 2012 in 22 institutions were obtained using WHONET 5.6 program. For interpretation of susceptibility results, CLSI standards of 2009 and 2012 were used. Using the Epi-Info 6.04 program a trends analysis of antibiotic resistance was done using the chi-square for linear trend with a confidence level of 95%, a value of p=0.05 was considered significant. Results: In six years of surveillance of antibiotic resistance we found a decrease of oxacillin resistance in Staphylococcus aureus (p=0.0006) and an increase of vancomycin resistance in Enterococcus faecium (p=0.0000). In Escherichia coli and Serratia marcescens an increase of resistance to ceftazidime was found, in contrast to a decrease in Klebsiella pneumoniae (p=0.0000) and Enterobacter cloacae (p=0.058). K. pneumoniae , S. marcescens and E. cloacae showed an increase of carbapenem resistance in contrast to a reduction of carbapenem resistance in Pseudomonas aeruginosa and Acinetobacter baumannii . Conclusions: The resistance surveillance identified important findings as the emergence of E. faecium resistant to vancomycin and carbapenem-resistant Enterobacteriaceae . It is essential to determine the antibiotic use in the region to establish their influence on the resistance profiles, as well as ensuring the quality of information and microbiological procedures in the microbiology laboratories.

O uso de indicadores da fase pré-analítica como ferramenta da gestão laboratorial / The use of indicators in the pre-analytical phase as a laboratory management tool

Introduction: Efficient laboratory services are the basis of modern health systems. Scientific innovations have contributed to substantial improvements in the laboratory environment, but errors still persist. These errors are classified as pre-analytical, analytical and post-analytical, according to the time of occurrence. Objective: To evaluate the frequency of pre-analytical errors in the clinical laboratory service of a military hospital. Methods: A total of 329,582 tests were performed in the clinical laboratory of Hospital Naval Marcílio Dias (HNMD) from August to October 2012, and pre-analytical errors were documented. Results: The most frequent cause of the observed pre-analytical errors was hemolysis (27.54%), followed by samples not received (25.43%) and insufficient sample volume (18.49%). The samples from the Integrated Home Care Service (SIAD) showed the highest frequency of errors (3.38%), followed by those from the inpatient (0.76%) and the outpatient departments (0.21%). Conclusion: Our study demonstrates the importance of managing laboratory pre-analytical quality in order to ensure service excellence...

Introdução: Serviços laboratoriais efetivos são a base dos sistemas de saúde modernos. Inovações científicas têm contribuído para melhorias substanciais no meio laboratorial, mas os erros ainda persistem. Esses erros são classificados como pré-analíticos, analíticos e pós-analíticos, dependendo do momento de sua ocorrência. Objetivo: Avaliar a frequência de erros pré-analíticos ocorridos no serviço de análises clínicas de um hospital militar. Métodos: Um total de 329.582 exames foram realizados no laboratório de análises clínicas do Hospital Naval Marcílio Dias no período de agosto a outubro de 2012, e os erros pré-analíticos documentados. Resultados: Os erros pré-analíticos mais observados foram decorrentes da hemólise (27,54%), seguidos de material não recebido (25,43%) e amostra insuficiente (18,49%). As amostras oriundas do Serviço Integrado de Atendimento Domiciliar (SIAD) foram as que apresentaram a maior frequência de erros (3,38%), seguidas pelo setor de pacientes internos (0,76%) e ambulatoriais (0,21%), respectivamente. Conclusão: Nosso estudo demonstra a importância da gestão da fase pré-analítica na garantia da qualidade laboratorial, de maneira a assegurar um serviço de excelência...

Desafios do Sistema Único de Saúde: situação da assistência laboratorial pública em 31 municípios de Minas Gerais, Brasil / Challenges of the Unified Health System: present status of public laboratory services in 31 cities of Minas Gerais, Brazil

Introduction: Modifications in the Brazilian Unified Health System (SUS) have led to a significant improvement in the national health indexes. However, some challenges still need to be faced, especially concerning SUS patients' access to high-quality laboratory support services. Objective: To evaluate the present status of laboratory services in SUS in 31 cities of Minas Gerais, Brazil, between 2008 and 2011. Material and method: This analysis was performed through data from the Information Technology Department of SUS (DATASUS) and through interviews with local public health managers with structured questionnaires. Results: Among all the studied cities, 21 had their own laboratory, 90.2% of which were in precarious conditions, not meeting the requirements established by the legislation in force, and employing inappropriate procedures and techniques, in addition to using obsolete equipment. The range of available laboratory tests was limited, what demanded the services of supporting laboratories. None of the evaluated laboratories developed any systematic activity on quality management, including control of analytical quality, maintenance of laboratory equipment, calibration and performance evaluation of critical equipment, continuing education programs, and safety and biosecurity. Conclusion: The effective role of laboratory test results in medical decision is unquestionably impaired, risking the safety of SUS patients. The present work reveals the deficiencies of public laboratory services in Minas Gerais, and proposes a new management model, which is able to associate operational quality, technological development and optimization of human and material resources with higher productivity...

Introdução: Desde a sua criação, modificações no Sistema Único de Saúde (SUS) levaram a uma melhoria significativa nos índices nacionais de saúde. No entanto, alguns desafios ainda precisam ser enfrentados, especialmente o acesso de pacientes do SUS aos serviços de apoio de laboratório de qualidade. Objetivo: Avaliar a situação atual da assistência laboratorial no SUS em 31 municípios de Minas Gerais, Brasil, entre 2008 e 2011. Material e método: Foi realizado levantamento de dados do Departamento de Informática do SUS (DATASUS) e de entrevistas com gestores utilizando questionário estruturado. Resultados: Dos municípios estudados, 21 possuíam laboratório próprio, sendo que 90,2% deles apresentavam instalações físicas precárias, fora das especificações previstas na legislação vigente, e empregavam procedimentos e técnicas inadequadas, com utilização de equipamentos obsoletos. O perfil de exames era restrito, necessitando da utilização de laboratórios de apoio. Nenhum dos laboratórios avaliados apresentava programas de educação permanente, de controle da qualidade dos exames laboratoriais, de manutenção dos equipamentos analíticos, de aferição de instrumentos críticos e de segurança e biossegurança. Conclusão: O papel efetivo dos resultados dos testes de laboratório na decisão médica mostrou-se, sem dúvida, prejudicado, acarretando risco à segurança dos pacientes usuários do SUS. O presente trabalho revelou a precariedade da assistência laboratorial pública em MG e propõe a mudança para um modelo de gestão capaz de aliar qualidade operacional, desenvolvimento tecnológico, otimização de recursos humanos e materiais...

Heat fixed but unstained slide smears are infectious to laboratory staff.

Background and Aim: In a clinical microbiology laboratory, heat fixed slide smears are commonly transported from one place to another for staining with different stains and also for onsite proficiency testing of laboratory technicians for accreditation of the laboratories. These smears are frequently handled without gloves by the staff in developing countries. Therefore, this study was conducted to check the survivability of tubercle bacilli on smears after physical and chemical treatments. Methods: A total of 196 AFB positive smears were analyzed. Of these, 116 were stained with Ziehl Neelsen (ZN), 60 with cold Kinyoun and 10 were unstained but heat fixed and 10 were neither stained nor heat fixed. The last 20 smears served as controls. The ZN and Kinyoun stained smears were 0-1.5-year-old and stored at room temperature in slide boxes, while control smears were freshly prepared. All smears were prepared from sputum samples positive for acid fast bacilli. All four sets were subjected to slide culture to see if mycobacteria could survive and grow in any. For slide culture, a new and safe device was used, which is designed for three in one purpose: cell cultivation, direct observation of the growth under microscope and cell harvesting inside the closed tube. The slide smears were directly dipped into this tube that contained liquid culture medium. The tubes were incubated at 370C for four weeks. The growth, if any, was confirmed by MPT-64 rapid test and subculture on LJ slants. Results: No growth was observed in ZN and Kinyoun stained slide smears. However, significant growth was observed in both control sets; the unstained non heat fixed as well as heat fixed slide smears. Conclusions: The results of our study indicate that tubercle bacilli remain viable even after heat fixation and carry risk of infection by contact. However, stained smears are safe for handling and storage.

Development of a Document Management System for the Standardization of Clinical Laboratory Documents

BACKGROUND: Documentation is very important; a considerable number of documents exist for use in accreditation inspection. However, most laboratories do not effectively manage the processes of documentation, organization, and storage. The purpose of this study was to facilitate the establishment of a strategically effective and sustainably standardized document management system. METHODS: A document code formatting system was modified by comparing the document list data received from 3 major university hospitals. In addition, a questionnaire regarding document code standardization was created and sent to 268 institutes to establish document classifications and generate a standard coding scheme. A computerized document management system was developed. RESULTS: Only 32% (8 out of 25 institutes) answered that they were able to identify all of the document types and their numbers. In total, 76% of institutes (19 out of 25) answered that a systematic document management system was necessary. Disorganized document files were systemized by classifying them into 8 major groups according to their characteristics: patient test records (T), test quality control (Q), manuals (M), equipment and environment management (E), statistics (S), division administration (A), department administration (R), and others (X). CONCLUSIONS: Our documentation system may serve as a basis for the standardization of documents and the creation of a document management system for all hospital laboratories.

Análisis de la monitorización de cinco indicadores de calidad del hemocultivo en un hospital universitario en Chile 2009-2011 / Quality indicators for blood culture: three years of monitoring at a university hospital in Chile

Blood culture is considered the "gold standard" for the diagnosis of bacteremia, critical condition with high morbidity and mortality. Because of its importance, it is estimated that the blood culture is a critical test that requires close monitoring on the quality with which the process is performed. The objective of this work is to show the results of the monitoring carried out during the past three years, of 5 quality indicators of blood cultures in the laboratory of the Hospital Clínico de la Pontificia Universidad Católica de Chile, considering pre-analytical, analytical and post-analytical aspects. In the 3 years monitored the mean contamination was 0,7%, 46% of adult bottles had adequate volume, match between Gram stain with final identification was 99.4%, 100% of correct participations were achieved in surveys of external quality control and Gram staining notification before 1 hour was 88.7%. With regard to proposed aims, in 2011 the laboratory complies with all, except the percentage of bottles with appropriate volume of blood inoculated. This indicator is very low and should be corrected as soon as possible since it is known that it is an important condition for optimum performance of blood cultures.

El hemocultivo es el "estándar de oro" para el diagnóstico de bacteriemia, condición grave de alta morbi-mortalidad. Por esto, se estima que el hemocultivo es un examen crítico, que requiere monitorización de su calidad. El objetivo de este trabajo es mostrar los resultados de la monitorización de 3 años de 5 indicadores de calidad del hemocultivo implementados en nuestro hospital. El porcentaje promedio de contaminación de las botellas para hemocultivo fue 0,7%, el porcentaje de botellas de adultos con volumen adecuado fue 46%, la concordancia de la tinción de Gram con la identificación final correspondió a 99,4%, el 100% de las participaciones en encuestas de control de calidad externo fueron correctas y 88,7% de los avisos de valores de alerta de la tinción de Gram fueron realizados antes de 1 hora. En el año 2011 se cumplió con las metas propuestas por el laboratorio para todos los indicadores, excepto con el porcentaje de botellas con volumen apropiado de sangre. Este último, se encuentra muy por debajo de la meta y debe ser mejorado a la brevedad, ya que el volumen de sangre cultivada es el factor más importante para obtener un rendimiento óptimo del hemocultivo.

Assessment of completion of forms requesting skin biopsies / Avaliação do preenchimento de solicitações de biópsias da pele

BACKGROUND: Information contained in request forms for histopathological examinations is essential for interpreting tissue changes observed in microscopy. OBJECTIVE: To determine the adequacy of information provided on forms requesting skin biopsies. METHOD: Assessment, in two health institutions, of 647 forms requesting skin biopsies in order to determine the completeness on the forms of the clinical details/items considered necessary for undertaking skin biopsies. RESULTS: Of the total 18 items on the forms, 7 were found to relay complete information in under 10% of the forms and only 9 items were correctly completed in over 80% of the requests. CONCLUSION: We concluded that information on many of the essential items required for a correct interpretation of the anatomopathologic examination was missing from the request forms.

FUNDAMENTOS: As informações contidas nas requisições de exames histopatológicos são fundamentais para a interpretação das alterações teciduais observadas na microscopia. OBJETIVO: Verificar a frequência do preenchimento de itens de requisições de biópsias da pele. MÉTODO: Avaliação do preenchimento de 647 solicitações de biópsias de pele, em duas instituições de saúde, em relação aos itens considerados necessários. RESULTADOS: De um total de 18 itens avaliados, 7 foram preenchidos em menos de 10% das requisições e 9 foram preenchidos corretamente em mais de 80% das requisições. CONCLUSÃO: Verificou-se uma insuficiência do preenchimento de itens fundamentais para uma interpretação adequada do exame anatomopatológico.

Analysis of Factors Influencing the Generation of Unqualified Clinical Samples and Measures to Prevent this Generation

BACKGROUND: We investigated the influence of pre-analytical factors on the results of clinical tests and thereby analyzed approaches to improve quality management in clinical laboratories. METHODS: Unqualified clinical samples were selected from all the samples received at our clinical laboratory. The data were collected for 2009 and 2010, i.e., the years before and after the establishment of the laboratory quality management system. The rate and causes of generation of unqualified samples were analyzed, and measures to improve the laboratory practices were studied and implemented. RESULTS: A total of 1,051 unqualified samples were identified from among the 553,158 samples (the overall incidence rate of unqualified samples was 0.19%). The number of unqualified samples substantially varied according to the nature of the sample, and clinical samples collected for routine blood tests or coagulation tests were the predominant unqualified samples. The main causes of generation of unqualified samples were insufficient sample volumes and improper methods of mixing the samples. The rate of generation of unqualified samples decreased significantly after the implementation of improvement measures (0.26% in 2009 vs. 0.13% in 2010, P<0.001). CONCLUSIONS: The number of unqualified samples decreased significantly after the establishment of the laboratory quality management system, which promoted active communication among and training of the clinical staff to reduce the occurrence of pre-analytical errors. Comprehensive control of pre-analytical factors is an important approach in improving the clinical laboratory practices.

Implementación de 9 indicadores de calidad en un laboratorio hospitalario / Implementation of nine quality indicators in a hospital emergency clinical laboratory

Background: Quality indicators are tools used to monitor specific activities within a process and improve it. In the area of clinical laboratories, the National Accreditation Standards for Providers of Health and the ISO 15189 standard recommend the implementation of indicators that monitor the test cycle with emphasis on those that contribute to a safer health care. Aim: To describe the implementation of nine indicators in a hospital clinical laboratory and their measurement during one year. Material and Methods: The indicators implemented and measured were four of the pre-analytical phase (number of rejected samples, times of transport, blood culture contamination and blood cultures inoculated with adequate blood volumes), two of the analytical phase (coherence of Gram stains of blood culture with microorganism cultured and correct results in external quality control surveys) and three of the post-analytical phase (compliance with order to report lapse goals, corrected reports and alert values report). Results: Two indicators of pre-analytical phase did not meet the per determined targets: number of rejected samples and blood cultures inoculated with adequate blood volume. All indicators of the analytical and post analytical phases were within thepre-determined targets. Conclusions: Coordinated work should be initiated especially with the nursing service to correct the two indicators that did not meet the target. The incorporation of quality indicators to monitor critical processes within the laboratory was undoubtedly an opportunity to identify areas for improvement.

Gestión de la calidad de atención en laboratorios clínicos de hospitales públicos en Maracaibo, Venezuela / Managing the quality of attention in public hospitals' clinical laboratories in Maracaibo, Venezuela

Objetivo Evaluar la gestión de calidad de los laboratorios según la perspectiva de sus usuarios externos, determinándose las dimensiones de la calidad relacionadas con su satisfacción y con las características sociodemográficas. Métodos El estudio es descriptivo, la muestra estuvo conformada por 1 875 pacientes de consulta externa que asistieron a laboratorios de hospitales públicos tipo III y IV nivel de atención ubicados en el área metropolitana del Estado Zulia, entre Octubre a Diciembre de 2008. Se aplicó una encuesta previamente validada. Para el análisis, se empleó distribución de frecuencias, análisis multivariante y análisis de la varianza. Resultados Los resultados mostraron que la mayoría de los usuarios son pacientes de sexo femenino (72,7 por ciento), de procedencia local (87,9 por ciento); en edades entre 15 y 45 años (65,7 por ciento) y con grado de instrucción primaria y secundaria (70,5 por ciento). El análisis multifactorial demostró que el componente Gestión de Calidad, puede ser valorado por las dimensiones: Accesibilidad, Elementos tangibles, Capacidad de Respuesta, Competencias profesionales y Seguridad. Hubo diferencias altamente significativas (p<0,001) entre los distintos grados de instrucción y la edad al calificar la gestión de calidad. Se detectaron debilidades en cuanto a tiempo de espera en recepción, comodidad de la sala de espera y uso de medidas de seguridad del personal técnico. Conclusión Los resultados permitirán establecer acciones tendentes a evaluar el grado de mejoramiento del servicio y las metas propuestas en pro de mejorar la calidad de atención, medidas que formarán parte de un programa de aseguramiento de la calidad conforme la normativa internacional.

Objective Evaluating how clinical laboratories' quality was being managed according to the view of external users, thereby determining the dimensions of quality related to their satisfaction and sociodemographic characteristics. Methods The study was descriptive; the sample consisted of 1,875 outpatients attending the laboratories of type 3 and 4 care level public hospitals located in the metropolitan area of Zulia State in Venezuela between October and December 2008. A previously validated survey was applied. Frequency allocation, multivariate analysis and variance analysis were used for analysing data. Results The results showed that the most users were female (72.7 percent), of local origin (87.9 percent), aged between 15 and 45 (65.7 percent) and had received primary and secondary education (70.5 percent). Multivariate analysis showed that quality management could be evaluated in terms of accessibility, tangible elements, response ability, safety and professional competence. There were highly significant differences (p<0.001) between educational level and age when evaluating management quality. Weaknesses were revealed concerning time spent waiting in reception, waiting room comfort and safety measures used by technical staff. Conclusions The results should lead to establishing action aimed at evaluating the degree of improvement in service and proposed targets for improving the quality of attention; such measures will form part of a quality assurance programme in accordance with international standards.

Completeness of low anterior resection pathology report: A hospital-based audit with recommendations on improving reporting.

Aims: To audit the information content of the pathology report on Low Anterior Resection (LAR) specimens and to provide recommendations in order to improve the existing standard of reporting. Materials and Methods : All the reports of LAR specimens during 2004 - 2005 were collected from the Hospital Information System (HIS). Individual items of information were compared with the minimum data sets provided by the Royal College of Pathologists (RCP). Results : Fifty-nine reports were audited. Nineteen percent of the reports were classified as satisfactory. Although many items were well reported, only 30.5% (18/59) of the reports contained a statement on the completeness of excision at the circumferential resected margin and only 25.4% of all reports mentioned the relation of tumors to the peritoneal reflection. Conclusion : The information content of the reports on colorectal cancer resection specimens is inadequate. The use of the standard proforma (template) for reporting rectal cancer is therefore recommended, along with improved education, review of laboratory practices in the light of current knowledge, and further motivation of pathologists through their involvement in multidisciplinary cancer management.

Aseguramiento de la calidad: gestión funcional de la informática del laboratorio de análisis clínicos / Insurance of the quality: functional management of the laboratory informatics of clinical analyses

Atento a las normas internacionales para la acreditación de los laboratorios clínicos habíamos propuesto, para el mediano plazo, establecer dos objetivos para nuestro laboratorio: implantar un Sistema de Gestión de la Calidad (SGC) y dotar al mismo de la informática apropiada, con vistas a la futura acreditación del servicio. En ocasión de la implantación del Sistema Informático del laboratorio se establecieron los siguientes estándares: Diseño de un protocolo único que abarca todas las secciones del laboratorio, identificación unívoca de pacientes por código universal, reducción del tiempo de espera de turnos y de atención, unificación de reportes, acceso a la trazabilidad de todos los procesos y a la información y reducción de costos por la detección temprana de errores. Paralelamente se capacitó al recurso humano para el desarrollo y utilización del Sistema Informático por medio de reuniones con todas las áreas del laboratorio. Se expusieron y analizaron los beneficios y la factibilidad operativa, a la vez que se evaluaron los indicadores pre-mejora. Para efectuar el diagnóstico de situación describimos los procesos del laboratorio con todos sus procedimientos administrativos pre-analíticos, analíticos y post-analíticos y luego de planificar la mejora, pusimos en marcha el plan operativo. Se analizaron 4.024 protocolos durante cuatro semanas. A los 20 días hábiles de la implementación monitoreamos los indicadores post-mejora, cuya disminución en un tiempo tan corto permite afirmar que el proceso está bien encaminado. La experiencia de esta mejora es el resultado de un ambicioso proyecto que refleja la producción y dificultades de un laboratorio de atención asistencial que aporta datos del conjunto de los sectores y muestra la visión del grupo de dirección del laboratorio a través de la actividad del servicio.

Application of indicators for quality improvement in the coagulation laboratory.

Indicators are tools that measure work performance and serve as a guide to improve the quality of laboratories. Seven Indicators for quality improvement have been established in our coagulation laboratory. They are :- 1). percentage of pre-analytical problems, 2). personnel competency scores, 3). results of external quality assessment, 4). % coefficient of variation (CV) of control materials, 5). unit cost, 6). percentage of reports within determined time, and 7). percentage of customers who were satisfied. The percentage of preanalytical error gradually decreased from 1.8% in April 2001 to 0.8% in June 2001 as a result of co-operation between the coagulation laboratory and the wards. Since there is no system to check personnel competency at a national level in Thailand, we set up a program for testing personnel competency in our department by asking every technician to take a written and practical laboratory examination. The scores achieved by our personnel ranged from 40 to 90%. For those who achieved scores of lower than 70%, we limited their responsibilities and organized a training program for them. In order to check our laboratory's accuracy, we are enrolled in the WHO International External Quality Assessment Scheme (IEQAS) in Blood Coagulation and have been since 1987. The survey results indicated that most of our laboratory tests were within consensus including our homemade ELISA tests for protein C, protein S and vWF antigen. The percent CVs of control materials used for the internal daily control for every test were analyzed. They ranged from 2.3 for normal APTT to 11.4 for the low level of free protein S in plasma. The unit cost for each test was analyzed to determine the cost-effectiveness of the laboratory. We set the goal for the turn around time for emergency coagulation tests to be within an hour and the percentage of reports within this time was 91.6% in August 2001. The last indicator was the percentage of satisfied customers, which gave an indication of the quality of all Out Patient Department (OPD) services performed by our department. We sent 400 questionnaires to doctors, nurses and patients in OPD asking their opinion of both the technical services and the behavior of our technicians. The percentage satisfaction of our customers concerning services offered to OPD was lower than 50%. We plan to improve the last 2 indicators by expanding the space of the OPD/emergency laboratory and reorganizing the service system. All indicators mentioned above have helped to improve the quality of our laboratory greatly.