Assessment of Culture and Laboratory Practices Related to Patient Safety in Brazilian Laboratories.

OBJECTIVES: This study aimed at the simultaneous assessment of culture and laboratory practices related to patient safety in Brazilian laboratories, and validation of the proposed questionnaire. METHODS: The questionnaire was based on the Hospital Survey on Patient Safety Culture, used by the 1.0 version of the Agency of Healthcare Research and Quality and other bibliographical references. The sample consisted of 1414 professionals from 51 different Brazilian clinical laboratories. Agency of Healthcare Research and Quality criteria were used to define "strengths and weaknesses" related to patient safety. The psychometric evaluation of the questionnaire included the analysis of reliability and validity. RESULTS: Patient safety in the laboratories was considered "excellent" (35.22%), "very good" (53.14%), "regular" (10.11%), "bad" (0.92%), and "very bad" (0.61%). The only dimension of culture with positivity less than 50% was "nonpunitive responses to errors" (30.74%). The dimensions on laboratory practices related to patient safety revealed positivity greater than 60%, with the "analytical" dimension (76.47%) being the highest. The psychometric evaluation revealed the reliability of the questionnaire, the applicability of 12 dimensions to assess culture, and 4 or 5 dimensions to assess laboratory practices related to patient safety. CONCLUSIONS: The culture and practices related to patient safety in Brazilian laboratories were evaluated as good, although a punitive culture against the occurrence of errors was identified. The psychometric evaluation of the questionnaire confirmed its reliability and validity. Studies performed in a larger and more diverse sample of clinical laboratories are needed to confirm the results obtained.

Brazilian laboratory indicators benchmarking program: three-year experience on pre-analytical quality indicators.

OBJECTIVES: In the laboratory medicine segment, benchmarking is the process in which institutions seek to compare with the macro environment (performance comparison and best practices with different laboratories) and improve their results based on quality indicators. The literature has highlighted the vulnerability of the pre-analytical phase in terms of risks and failures and the use of interlaboratory comparison as an opportunity to define a strategic performance benchmark aligned with the laboratory medicine sector, which has been a promising strategy to ensure continuous improvement, identifying within the pre-analytical process the critical activities to guarantee patient safety. In this context, this paper aims to present the three-year experience (2016-2018) of the Benchmarking Program and Laboratory Indicators - in Portuguese, Programa de Benchmarking e Indicadores Laboratoriais (PBIL) - with emphasis on pre-analytical indicators and their comparison against literature references and other programs of benchmarking in the area of laboratory medicine. PBIL is organized by the Brazilian Society of Clinical Pathology/Laboratory Medicine (SBPC/ML) in conjunction with Controllab and coordinated by a Brazilian group with representatives from different countries. METHODS: The data presented in this paper involving the performance results of 180 laboratories with active participation. Results are presented in percentage (%, boxplot graphical in quartiles) and Sigma metric, recognized as the metric that best indicates the magnitude of failures in a process. The Pareto Chart was used to facilitate ordering and to identify the main errors in the pre-analytical phase. The Radar Chart was made available in this work for the purpose of comparing the results obtained in Sigma by the PBIL and IFCC Working Group Laboratory Errors and Patient Safety (WG LEPS). RESULTS: In the study period, just over 80% of the pre-analytical failures are related to Blood culture contamination (hospital-based and non-hospital-based laboratories), Recollect and Non-registered exams, with failure rates of 2.70, 1.05 and 0.63%, respectively. The performance of the PBIL program participants was in line with the literature references, and allowed to identify benchmarks in the laboratory medicine market, target of PBIL, with best practices were observed for some indicators. CONCLUSIONS: The results of the program demonstrate the importance of an ongoing program comparative performance-monitoring program for setting more robust goals and consequently reducing laboratory process failures. Even with these promising premises and results, the contextualized analysis of the program indicators, point to a still significant number of failures in our market, with possibilities for improvement in order aiming to ensure more robust and effective processes.

Results of laboratory tests not accessed in Brazilian private laboratories / Resultados de exames laboratoriais não acessados em laboratórios privados brasileiros

ABSTRACT Background: Laboratory medicine is an important part of the health care system and directly contributes to preventive actions, diagnostics, treatment, and management of diseases. The level and quality of laboratory resources utilization have been frequently questioned. A dissemination of conflicting data regarding the amount of laboratory tests not accessed by the requesting doctors or by the patients themselves is observed, although very often the sources and methodologies used to access these numbers are not properly clarified. Objective: The objective of this study was to obtain data on access to tests results performed in Brazilian private clinical analysis laboratories using the laboratory information system developed by SHIFT Consultoria e Sistemas (Consulting and Systems). Methods: The information was extracted from 81 laboratories, responsible for the performance of 93,240,651 tests, collected from 7,067,087 patients. Results: The total number of tests not accessed, considering all the regions, was 5,071,454, corresponding to a proportion of 5.4%. Due to the potential risks of adverse events or impacts on diagnostic and treatment management, including the economic impacts due to prolonged hospitalization time, the 17.9% proportion which was found to correspond to "not accessed" tests showing "abnormal" results. It is of particular concern, mainly if we observe that from these, 2.5% were related to "abnormal" test results processed by laboratories working in hospital units. Conclusion: Due to the relevance of the theme, Sociedade Brasileira de Patologia Clínica/Medicina Laboratorial (SBPC/ML), will keep encouraging the monitoring and utilization of adequate laboratory resources, in order to enable sustainable health care systems.

RESUMEN Introducción: La medicina de laboratorio es una parte importante del sistema de salud y contribuye directamente a las acciones preventivas, diagnósticos, tratamiento y manejo de enfermedades. Elnivel y la calidadde la utilización de los recursos de laboratorio se han cuestionado con frecuencia. Se observa una diseminación de datos contradictorios sobre la cantidadde pruebas de laboratorio a las que no han accedido los médicos solicitantes o los propios pacientes, aunque muy a menudo las fuentes y metodologias utilizadas para obtener esas cifras no se aclaran adecuadamente. Objetivo: El objetivo de este estudio fue obtener datos sobre el acceso a los resultados de las pruebas realizadas en los laboratorios de análisis clínicos privados de Brasil que utilizan el sistema de información de laboratorio desarrolladopor SHIFT Consultoria e Sistemas. Métodos: La información se extrajo de 81 laboratorios, que fueron responsables del rendimiento de 93,240,651 pruebas, recolectadas de 7,067,087pacientes. Resultados: El número total de pruebas a las que no se accedió, considerando todas las regiones, fue de 5,071,454, lo que corresponde a una proporción del 5,4%. Ante los riesgos potenciales de eventos adversos o impactos en el manejo de diagnósticos y tratamientos, incluidos los impactos económicos debido al tiempo prolongado de hospitalización, la proporción del 17,9% que se encontró correspondiente a las pruebas "no accedidas" muestra resultados "anormales" es preocupante, principalmente si observamos que de ellos, el 2,5% se relacionó con resultados depruebas "anormales" procesadospor laboratorios que trabajan en la atención hospitalaria. Conclusión: Sociedade Brasileira de Patologia Clínica/Medicina Laboratorial (SBPC/ML), ante la relevancia del tema, continuará estimulando el monitoreo y la utilización de recursos de laboratorio adecuados para permitir sistemas de salud sostenibles.

RESUMO Introdução: A medicina laboratorial é uma parte importante do sistema de saúde e contribui diretamente para ações preventivas e de diagnósticos, tratamento e monitoramento de doenças. O nível e a qualidade da utilização de recursos laboratoriais são frequentemente questionados. Observa-se uma disseminação de dados conflitantes em relação à quantidade de resultados de exames laboratoriais não acessados pelos médicos solicitantes ou pelos próprios pacientes, embora muitas vezes as fontes e as metodologias utilizadas para acessar esses números não sejam devidamente esclarecidas. Objetivo: O objetivo deste estudo foi obter dados sobre o acesso aos resultados de testes realizados em laboratórios de análises clínicas privados brasileiros que utilizam o sistema de informações laboratoriais desenvolvido pela SHIFT Consultoria e Sistemas. Métodos: As informações foram extraídas de 81 laboratórios, responsáveis pelo desempenho de 93.240.651 testes, coletados de 7.067.087pacientes. Resultados: O total de resultados de exames não acessados, considerando todas as regiões, foi de 5.071.454, correspondendo a uma proporção de 5,4%. Diante dos riscos potenciais de eventos adversos ou de impactos na gestão de diagnósticos e tratamentos, incluindo os impactos econômicos decorrentes do tempo prolongado de internação, a proporção de 17,9% encontrada correspondente a testes não acessados com resultados "anormais" é preocupante, principalmente se observarmos que 2,5%foram relacionados com resultados de testes "anormais" processados por laboratórios que trabalham em unidades hospitalares. Conclusão: A Sociedade Brasileira de Patologia Clínica/Medicina Laboratorial (SBPC/ML), diante da relevância do tema, continuará estimulando o monitoramento e a utilização de recursos laboratoriais adequados, a fim de permitir sistemas de saúde sustentáveis.

Results of Laboratory Tests not Accessed in Brazilian Private Laboratories.

BACKGROUND: Laboratory medicine is an important part of the healthcare system and directly contributes to preventive actions, diagnostics, treatment, and management of diseases. The level and quality of the utilization of laboratory resources have been frequently questioned. A dissemination of conflicting data regarding the quantity of laboratory tests not accessed by the requesting doctors or by the patients themselves is observed, although very often the sources and methodologies used to raise those numbers are not properly clarified. The objective of this study was to obtain data about access to results of tests taken in Brazilian private clinical analysis laboratories which use the laboratory information system developed by SHIFT Consultoria e Sistemas. METHODS: Information was extracted from 81 laboratories, which were responsible for the performance of 93,240,651 tests, collected from 7,067,087 patients. RESULTS: The total number of tests not accessed, considering all the regions, was 5,071,454, corresponding to a proportion of 5.4%. In the face of the potential risks of adverse events or impacts in the management of diagnostics and treatments, including economic impacts due to prolonged hospitalization time, the proportion of 17.9% which was found corresponding to tests "not accessed" showing "abnormal" results, is worrisome, mainly if we observe that of those, 2.5% were related to "abnormal" test results processed by laboratories which work in hospital care. CONCLUSIONS: SBPC/ML, in face of the relevance of the theme, will keep stimulating the monitoring and utilization of adequate laboratory resources, in order to allow sustainable healthcare systems.

Clinical Applications of Point-of-Care Testing in Different Conditions.

BACKGROUND: The use of point-of-care testing (POCT) in different clinical applications is justified by the fact that the time to release the result is shortened, allowing the physician to define the diagnosis and most appropriate therapy in a shorter time. However, the negative aspects must also be highlighted and studied so that we can move forward with the use of these devices. These negative aspects include greater analytical imprecision compared to laboratory automation, the variability between different equipment from different manufacturers, the risk of inappropriate use, a low level of global regulation, higher costs compared with laboratory testing and cost ineffectiveness in terms of health care. Methods and. RESULTS: This review presents some clinical applications of POCT in different scenarios, such as for diabetes mellitus, infectious diseases, pediatrics, and chronic kidney disease, among others. CONCLUSIONS: We hope to see a global consensus on an acceptable quality standard for performing POCT that is adaptable, practical, and cost effective in primary care settings, ensuring patient safety, and minimizing the risk of harm.

Point-of-Care Testing: General Aspects.

Point-of-Care Testing (POCT) has been highlighted in the health care sector in recent decades. On the other hand, due to its low demand, POCT is at a disadvantage compared to conventional equipment, since its cost is inversely proportional to the volume of use. In addition, for the implementation of POCT to succeed, it is essential to rely on the work of a multidisciplinary team. The awareness of health professionals of the importance of each step is perhaps the critical success factor. The trend towards the continuous advancement of the use of POCT and the great potential of its contributions reinforce the need to implement quality management tools, including performance indicators, to ensure their results. This review presents some advantages and disadvantages concerning POCT and the real need to use it. A worldwide call for the availability of easy-to-use health technologies that are increasingly closer to the final user is one of the main reasons for this focus.

Defining a roadmap for harmonizing quality indicators in Laboratory Medicine: a consensus statement on behalf of the IFCC Working Group "Laboratory Error and Patient Safety" and EFLM Task and Finish Group "Performance specifications for the extra-analytical phases".

The improving quality of laboratory testing requires a deep understanding of the many vulnerable steps involved in the total examination process (TEP), along with the identification of a hierarchy of risks and challenges that need to be addressed. From this perspective, the Working Group "Laboratory Errors and Patient Safety" (WG-LEPS) of International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) is focusing its activity on implementation of an efficient tool for obtaining meaningful information on the risk of errors developing throughout the TEP, and for establishing reliable information about error frequencies and their distribution. More recently, the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) has created the Task and Finish Group "Performance specifications for the extra-analytical phases" (TFG-PSEP) for defining performance specifications for extra-analytical phases. Both the IFCC and EFLM groups are working to provide laboratories with a system to evaluate their performances and recognize the critical aspects where improvement actions are needed. A Consensus Conference was organized in Padova, Italy, in 2016 in order to bring together all the experts and interested parties to achieve a consensus for effective harmonization of quality indicators (QIs). A general agreement was achieved and the main outcomes have been the release of a new version of model of quality indicators (MQI), the approval of a criterion for establishing performance specifications and the definition of the type of information that should be provided within the report to the clinical laboratories participating to the QIs project.

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...

Harmonization of quality indicators in laboratory medicine. A preliminary consensus.

Quality indicators (QIs) are fundamental tools for enabling users to quantify the quality of all operational processes by comparing it against a defined criterion. QIs data should be collected over time to identify, correct, and continuously monitor defects and improve performance and patient safety by identifying and implementing effective interventions. According to the international standard for medical laboratories accreditation, the laboratory shall establish and periodically review QIs to monitor and evaluate performance throughout critical aspects of pre-, intra-, and post-analytical processes. However, while some interesting programs on indicators in the total testing process have been developed in some countries, there is no consensus for the production of joint recommendations focusing on the adoption of universal QIs and common terminology in the total testing process. A preliminary agreement has been achieved in a Consensus Conference organized in Padua in 2013, after revising the model of quality indicators (MQI) developed by the Working Group on "Laboratory Errors and Patient Safety" of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). The consensually accepted list of QIs, which takes into consideration both their importance and applicability, should be tested by all potentially interested clinical laboratories to identify further steps in the harmonization project.

Laboratory errors, adverse events and research methodologies: a systematic review / Erros laboratoriais, eventos adversos e metodologias de estudo: uma revisão sistemática

Systematic review.

Revisão sistemática.

Brazilian laboratory indicators program.

BACKGROUND: This paper describes the evolution, structure, operation and some outcomes of the Brazilian Laboratory Indicators Program created by the Brazilian Society of Clinical Pathology/Laboratory Medicine (Sociedade Brasileira de Patologia Clínica/Medicina Laboratorial, or SBPC/ML), in partnership with ControlLab, a Brazilian Company that provides services for proficiency testing, internal control, calibration, and training indicators for clinical laboratories. METHODS: This web-based program is confidential for all participants. It contains 61 indicators categorized into three groups. Program operation and data analysis methods are described and indicators are reported in box plot format, with grouping varying in accordance with the profiles of the participating laboratories. Three indicators were selected as examples of program effectiveness in 2011: hemolysis, blood re-collection and productivity. RESULTS: Participants profile, examples of three indicators for the year 2011 (hemolysis, blood re-collection and productivity) and exploratory research conducted in 2012 on the implementation of the program are presented. Data related to laboratories participating in the program from 2006 to 2011 were collected and graphically represented. CONCLUSIONS: The Brazilian Laboratory Indicators Program brings important benefits for participants, contributing to the improvement of existing health systems in Brazil.

Erros laboratoriais e segurança dos pacientes: revisão sistemática / Laboratory errors and patient safety: a systematic review

Introdução - Os laboratórios clínicos são parte da cadeia de assistência à saúde, exercendo, historicamente, importante papel no suporte às decisões clínicas. A realização de exames laboratoriais ocorre num ambiente complexo, onde coexistem procedimentos, equipamentos, tecnologia e conhecimento humano, com o objetivo de garantir resultados que orientem decisões diagnósticas e terapêuticas. Informações laboratoriais erradas, ocasionadas por falhas no processo laboratorial e transmitidas aos médicos, podem afetar diretamente os resultados da assistência e a segurança do paciente.Metodologia - Foi realizada uma revisão sistemática, com o objetivo de identificar estudos sobre erros laboratoriais relacionados à segurança do paciente e seus efeitos, entendendo-se segurança do paciente como “a redução, ao mínimo aceitável, do risco de dano desnecessário associado à assistência à saúde” (OMS, 2009). Os estudos foram categorizados pelos a) métodos empregados e b) pela frequência dos incidentes. As metodologias utilizadas pelos autores dos estudos incluídos foram discutidas quanto à possibilidade de aplicação no Brasil, para fins de monitoramento de erros laboratoriais e prevenção de eventos adversos deles decorrentes. As fontes bibliográficas utilizadas nas buscas eletrônicas foram: MEDLINE, por meio da interface do PubMed, COCHRANE, LILACS, ScieELO, SCOPUS, WEB of SCIENCE e o banco de dados de teses e dissertações da Coordenadoria de Aperfeiçoamento de Pessoal de Nível Superior – (CAPES). Os incidentes descritos nos estudos foram classificados quanto: a) à fase do processo laboratorial envolvida; b) ao caráter cognitivo; c) à evitabilidade e d) ao impacto na segurança do paciente. Resultados – Foram encontrados nove artigos, que descreveram eventos adversos originados de erros laboratoriais, de acordo com os critérios pré-definidos. Os estudos abrangeram diferentes tipos de laboratórios, setores técnicos e origem de erros, segundo a fase do processo laboratorial. Os estudos selecionados evidenciaram eventos adversos relacionados a erros laboratoriais e fornecem uma gama de métodos que poderiam ser utilizados na realidade brasileira, e que permitiriam conhecer melhor e monitorar danos aos pacientes causados pelos erros cometidos nos laboratórios clínicos. As proporções de eventos adversos relatados e os impactos clínicos variaram, levando à consequências descritas como: desde nenhuma influência na assistência, até a danos decorrentes da flebotomia, recoleta de amostras, repetições de exames, atrasos na liberação de resultados de exames, influência no diagnóstico e/ou tratamento tratamentos impróprios e/ou desnecessários, realização de investigação adicional desnecessária, internação em unidade de terapia intensiva e óbitos. Conclusão: Existem estudos que associam eventos adversos a erros laboratoriais. Algumas metodologias utilizadas nos estudos podem ser aplicadas no Brasil, de modo a propiciar o conhecimento da magnitude do problema e traçar estratégias visando à prevenção de eventos adversos, à melhoria e monitoramento contínuo dos serviços laboratoriais.

Coleta, transporte e armazenamento de amostras para diagnóstico molecular / Collection, transport and storage of samples for molecular diagnosis

A Sociedade Brasileira de Patologia Clínica/Medicina Laboratorial (SBPC/ML) lançou, em seu 44º Congresso Brasileiro de Patologia Clínica e Medicina Laboratorial, uma série de recomendações para minimizar os erros na fase pré-analítica, sendo este texto uma delas. Além do crescimento do mercado de testes moleculares, é frequente a percepção errônea de que esses testes são menos sujeitos a erros. Enfatizamos, neste documento, que certos cuidados na fase pré-analítica são extremamente importantes para garantir a confiabilidade de testes moleculares.

The Brazilian Society of Clinical Pathology/Laboratory Medicine (SBPC/ML) launched a series of recommendations on how to minimize errors on the pre-analytical testing phase during the 44th Brazilian Congress of Clinical Pathology and Laboratory Medicine. This is one of them. The molecular diagnostics market is growing fast and many people believe these tests are less error-prone. In this study we highlight that proper care during the pre-analytical phase is extremely important in order to ensure the reliability of molecular diagnostic tests.

Erros em laboratórios clínicos / Erros in the clinical laboratory

Foram abordados vários aspectos dos erros médicos, especialmente os relacionados ao laboratório clínico, incluindo o estudo de sua análise e formas de gerenciamento, de modo a garantir a credibilidade deste serviço frente a médicos, pacientes e opiniäo pública em geral. O fator humano e sistêmico como fontes de erros, a interaçäo com a automaçäo, e a tecnologia da informaçäo säo analisados, assim como a utilidade dos Sistemas de Acreditaçäo