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Over the past decade, increasing off-label use of quetiapine has been reported worldwide from various sources. We wanted to investigate how this is reflected in therapeutic drug monitoring (TDM) data. Requisitions for serum concentration measurements of quetiapine from a TDM service in Central Norway during 2001-2019 were obtained and analysed for age, gender, trends in quetiapine doses, serum concentrations and indicators of diagnoses. There were 19 759 requisitions from 7459 individuals. Daily doses of quetiapine decreased by 24 mg per year (95% CI: -25.61 to -21.48, p < 0.001, N = 4505). A corresponding decrease in quetiapine serum concentrations was not seen. The proportion of requisitions with diagnoses indicating reimbursable use was 13% for the whole study period. Mean daily doses were slightly higher in the reimbursable group, but declined over time in these samples, as well. To our understanding, these results signal a trend towards lower prescribed doses of quetiapine, possibly reflecting drug repurposing and/or off-label use. The discrepancy in the decrease of doses versus serum concentrations may reflect the intake of higher doses than prescribed and/or inappropriate TDM sampling. Our findings show that TDM data have limitations when it comes to making inferences about the use of quetiapine based on serum concentrations and clinical information on the requisitions.

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Aims: To evaluate the performance of two matrix-assisted laser desorption/ionization-time-of-flight mass spectrometry platforms to identify molds isolated from clinical specimens. Methods: Fifty mold isolates were analyzed on Bruker Biotyper® and Vitek® MS platforms. Two Bruker Biotyper extraction protocols were assessed alongside the US FDA-approved extraction protocol for Vitek MS. Results: The Bruker Biotyper modified NIH-developed extraction protocol correctly identified more isolates than Bruker's protocol (56 vs 33%). For species in the manufacturers' databases, Vitek MS correctly identified 85% of isolates, with 8% misidentifications. The Bruker Biotyper identified 64%, with no misidentifications. For isolates not in the databases, the Bruker Biotyper did not misidentify any, and Vitek MS misidentified 36%. Conclusion: Both the Vitek MS and Bruker Biotyper accurately identified the fungal isolates, however Vitek MS was more likely to misidentify isolates than the Bruker Biotyper.

There are two different mass spectrometry systems that can be used in the hospital laboratory to find out what kind of mold is growing from a patient sample: the Vitek^® MS and Bruker Biotyper^® systems. This study compared how well they work for mold identification and also looked at two different ways to prepare the mold for testing. The Vitek MS system identified more molds, but also made more mistakes when identifying them. The Bruker Biotyper identified fewer molds but did not make any mistakes on the identification. The Vitek MS system sometimes gets the type of mold wrong, so more tests may be needed to be sure of the result. The Bruker Biotyper is more accurate because it got all of the molds correct, but it could not identify as many.

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INTRODUCTION: Coronavirus disease 2019 (COVID-19), is a respiratory illness caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The Clinical Blood Sciences Laboratory (CBSL) plays a key role in supporting the monitoring and management of patients with COVID-19 disease. OBJECTIVE: To provide a comprehensive CBSL testing protocol to support the medical management of SARS-CoV-2 infection. METHODS: Description of the biochemical, haematological and immunological tests that have a role in the assessment and monitoring of patients with COVID-19 infection. RESULTS: We provide a test menu for clinical laboratories to ensure the effective monitoring, management and prognostication of COVID-19 patients in hospital. CONCLUSION: Given the rapidity with which patients with COVID-19 disease can deteriorate, we recommend regular testing with vigilance paid to the rate and trajectory of change in each of these parameters.

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ABSTRACT COVID-19 started in China on December 31, 2019 and has since been the subject of several studies in medical field. There is not much evidence about the pregnancy and puerperium with the susceptibility of coronavirus infection (COVID-19). The present work reports the laboratory and radiological aspects of a puerperium patient. A positive test for severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) generally confirms the diagnosis of COVID-19, although false-positive and false-negative tests are possible. The test considered the gold standard for the diagnosis of coronavirus infection (COVID-19) is from in vivo or post-mortem polymerase chain reaction (PCR) sample. The purpose of the present case report is to demonstrate the case of a puerperium patient with an unfavorable clinical evolution, giving special attention to laboratory tests that were practically unchanged.

RESUMEN La COVID-19 se originó en China, el 31 de diciembre de 2019, y, desde entonces, ha sido objeto de varios estudios médicos. No hay evidencias sobre la relación del embarazo y del puerperio con la susceptibilidad a la infección por coronavirus. El presente estudio reporta aspectos de laboratorio y radiológicos de una paciente en puerperio. Una prueba positiva para el coronavirus del síndrome respiratorio agudo grave 2 (SARS-CoV-2) por lo general confirma el diagnóstico de COVID-19, a pesar de que falso positivos y falso negativos sean posibles. El método considerado el test de referencia para el diagnóstico de la infección por coronavirus es la muestra in vivo o post mortem por reacción en cadena de la polimerasa (PCR). El objetivo de este reporte es demostrar el caso de una paciente en puerperio con evolución clínica desfavorable, poniendo especial atención a los análisis de laboratorio que estaban prácticamente sin cambios.

RESUMO A COVID-19 teve início na China, em 31 de dezembro de 2019 e, desde então, tem sido alvo de diversos estudos na área médica. Não há muitas evidências sobre a relação da gravidez e do puerpério com a suscetibilidade da infecção pelo coronavírus. O presente estudo relata os aspectos laboratoriais e radiológicos de uma paciente no puerpério. Um teste positivo para a síndrome respiratória aguda severa-coronavírus 2 (SARS-CoV-2) geralmente confirma o diagnóstico de COVID-19, embora testes falso positivos e falso negativos sejam possíveis. O exame considerado padrão-ouro para o diagnóstico da infecção pelo coronavírus é a amostra in vivo ou post-mortem por reação em cadeia da polimerase (PCR). O objetivo deste relato é demonstrar o caso de uma paciente no puerpério com evolução desfavorável do quadro clínico, dando atenção especial para exames laboratoriais que estavam praticamente sem alterações.

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ABSTRACT Introduction: Time for releasing test results and critical value communication by the clinical laboratory are considered important determinants of patients' length of stay in the Emergency Department (ED). As well as physician satisfaction, they are used as quality indicators of the Clinical Analysis Service (CAS). Objective: The aim of this study was to evaluate the time to return a test result, the communication of critical values and the level of satisfaction of the ED physicians of a university hospital with the CAS. Material and methods: A physician satisfaction survey was conducted using a questionnaire. The test turnaround time for emergency requests was analyzed by observation of the pre-analytical phase and monitoring the analytical and post-analytical phases through the laboratory information system. In order to evaluate the communication of critical values by the CAS, a document analysis of the process was performed. Results: Physicians' overall satisfaction with the CAS was considered average. Greater satisfaction was observed with reliability of the results and the staff courtesy and lesser with the delivery time of results. The test turnaround time exceeded clinicians' expectations and the average described in the literature. No experience with critical-value communication was perceived. Conclusion: The results show several opportunities for progress in the relationship between ED and CAS. The improvement of laboratory quality indicators also depends on the involvement of ED physicians and nurses and embraces monitoring, planning, education and investment in system computerization.

RESUMEN Introducción: El tiempo de entrega de pruebas y la comunicación de valores críticos por el laboratorio clínico son considerados factores determinantes del tiempo de permanencia del paciente en la Sección de Urgencias (SU). Por lo tanto, así como la satisfacción de los médicos, estos datos también son utilizados como indicadores de calidad del Servicio de Análisis Clínicos (SAC). Objetivo: Evaluar el tiempo de entrega de pruebas, la comunicación de valores críticos y el grado de satisfacción de los médicos de la SU de un hospital universitario con el SAC. Material y método: Se realizó una encuesta de satisfacción de los médicos, utilizando un cuestionario. El tiempo de reporte de resultados en la SU ha sido analizado por medio de observación presencial de la fase preanalítica y monitoreo en el sistema computorizado de las fases analítica y postanalítica del laboratorio. Para evaluar la comunicación de valores críticos por el SAC, un análisis documental del proceso ha sido realizado. Resultados: La satisfacción general con el SAC fue considerada regular por los médicos participantes; hubo mayor satisfacción con la confianza en los resultados y con la atención del personal, y menor con el tiempo de entrega de resultados. Los tiempos de reporte han sido más largos que las expectativas de los médicosy la media descripta en la literatura. No se ha observado una cultura de comunicación de valores críticos. Conclusión: Los resultados han ensenado varias oportunidades deprogreso en la relación entre SUy SAC. La mejoría de los indicadores de calidad de laboratorio evaluados depende también del envolvimiento de los médicos y enfermeros del SU e incluye monitoreo, planeamiento, educación e investimento en informatización del sistema.

RESUMO Introdução: O tempo de liberação de exames e a comunicação de valores críticos pelo laboratório clínico são considerados importantes determinantes do tempo de permanência do paciente no Serviço de Emergência (SE). Portanto, assim como a satisfação dos médicos, esses dados também são utilizados como indicadores de qualidade do Serviço de Análises Clínicas (SACL). Objetivo: Avaliar o tempo de liberação de exames, a comunicação de valores críticos e o nível de satisfação dos médicos do SE de um hospital universitário em relação ao SACL. Material e métodos: Foi realizada uma pesquisa de satisfação dos médicos, utilizando um questionário. O tempo de liberação dos resultados de exames de emergência foi analisado por meio de observação presencial da fase pré-analítica e monitoramento no sistema informatizado das fases analítica e pós-analítica do laboratório. Para avaliar a comunicação de valores críticos pelo SACL, foi realizada análise documental do processo. Resultados: A satisfação geral com o SACL foi considerada regular pelos médicos participantes, com maior satisfação quanto à confiança nos resultados e à cortesia dos servidores e menor quanto ao tempo de entrega de resultados. Os tempos de liberação de resultados dos exames ultrapassaram as expectativas dos médicos e a média descrita na literatura. Não foi observada cultura de comunicação de valores críticos. Conclusão: Os resultados demonstraram várias oportunidades de progresso na relação entre o SE e o SACL. A melhoria dos indicadores da qualidade laboratorial avaliados depende também do envolvimento dos médicos e dos enfermeiros do SE e inclui monitoramento, planejamento, educação e investimento em informatização do sistema.

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BACKGROUND: To prevent medically significant errors, hospital laboratories must perform thorough statistical quality control (QC) procedures. We surveyed the QC status of small laboratories and created new statistical QC software that they can easily use for improving QC. METHODS: A questionnaire on the status of external and internal QC was created and sent to clinics and hospitals with small-scale laboratories. We then created QC software that can be downloaded and installed for free. RESULTS: External quality assessments were performed in 32% of the clinics (22 of 66) and 52% of the hospitals (12 of 23). Seventy-three percent of all institutions (66 of 90) carried out an internal quality assessment based on their own guidelines, mostly using commercialized QC materials. However, only 52% of clinics and 23% of hospitals used their own acceptable range instead of the manufacturer's expected range. In addition, the proportion of manual QC management reached 52% in clinics and 82% in hospitals. The QC software we designed covers all the basic functions of statistical QC and aims to improve the quality of laboratories. CONCLUSIONS: We obtained basic data on the current status of external and internal QC in small-scale laboratories using this survey. Furthermore, we suggested that new QC software may actually help to improve QC of small laboratories.

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BACKGROUND: Logical Observation Identifiers Names and Codes (LOINC) are a standard for identifying and reporting laboratory investigations that were developed and are maintained by the Regenstrief Institute. LOINC codes have been adopted globally by hospitals, government agencies, laboratories, and research institutions. There are still many healthcare organizations, however, that have not adopted LOINC codes, including rural hospitals in low- and middle- income countries. Hence, organizations in these areas do not receive the benefits that accrue with the adoption of LOINC codes. METHODS: We conducted a literature search by utilizing PubMed, CINAHL, Google Scholar, ACM Digital Library, and the Biomed Central database to look for existing publications on the benefits and challenges of adopting LOINC. We selected and reviewed 16 publications and then conducted a case study via the following steps: (1) we brainstormed, discussed, analyzed, created and revised iteratively the patient's clinical encounter (outpatient or ambulatory settings) process within a laboratory department via utilizing a hypothetical patient; (2) we incorporated the work experience of one of the authors (CU) in a rural hospital laboratory department in Nigeria to break down the clinical encounter process into simpler and discrete steps and created a series of use cases for the process; (3) we then analyzed and summarized the potential usage of LOINC codes (clinically, administratively, and operationally) and the benefits and challenges of adopting LOINC codes in such settings by examining the use cases one by one. RESULTS: Based on the literature review, we noted that LOINC codes' ability to improve laboratory results' interoperability has been recognized broadly. LOINC-coded laboratory results can improve patients' safety due to their consistent meaning as well as the related reduction of duplicate lab tests, easier assessment of workloads in the laboratory departments, and accurate auditing of laboratory accounts. Further, the adoption of LOINC codes may motivate government agencies to upgrade hospitals' infrastructures, which could increase the possibility of international recognition of laboratory test results from those hospitals over the long term. Meanwhile, a lack of LOINC codes in paper format and a lack of LOINC codes experts are major challenges that may limit LOINC adoption. CONCLUSION: In this paper, we intend to provide a snapshot of the possible usage of LOINC codes in rural hospitals in low- and middle-income countries via simpler and detailed use cases. Our analysis may aid policymakers to gain a deeper understanding of LOINC codes in regard to clinical, administrative, and operational aspect and to make better-informed decisions in regard to LOINC codes adoption. The use case analysis also can be used by information system designers and developers to reference workflow within a laboratory department. We recognize that this manuscript is only a case study and that the exact steps and workflows may vary in different laboratory departments; however, the core steps and main benefits should be consistent.

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ABSTRACT The critical value is a laboratory result representing a pathophysiological state that offers risk to a patient's life. The communication of these results is a laboratory responsibility and, according to the literature, 95% of physicians consider it useful in decision-making and patient management. Two-thirds of critical results lead to some change in therapeutic approach. The communication of critical results is a requirement for laboratory accreditation programs. Thus laboratories should establish a list of tests, their critical values, and the procedure describing the communication flow. The performance indicator for this activity should consider the time between results release and their effective communication, and the percentage of successful communication. There is no standardization of laboratory parameters that need to have critical values established, not even the ranges to be considered for notification purposes. The frequent update of test lists and critical value ranges based on literature reviews and on experience exchange among clinical laboratories ensure the continuous improvement process for this procedure and patient safety.

RESUMO O valor crítico é um resultado laboratorial que representa um estado fisiopatológico de risco à vida do paciente. A comunicação desses resultados é de responsabilidade do laboratório e, segundo a literatura, 95% dos médicos a considera útil na adoção de condutas e no manuseio dos pacientes. Dois terços dos resultados críticos resultam em alguma mudança na conduta terapêutica. A comunicação dos resultados críticos é um procedimento previsto nas listas de verificação dos programas de acreditação laboratorial, portanto o laboratório deve estabelecer a lista dos exames, os respectivos valores críticos e o procedimento, descrevendo o fluxo de comunicação. O indicador de desempenho para esta atividade deve considerar o tempo decorrido entre a liberação do resultado e a sua efetiva comunicação e o percentual de sucesso na comunicação. Não existe padronização acerca dos parâmetros laboratoriais que necessitam ter valores críticos estabelecidos, nem mesmo os intervalos a serem considerados para fins de notificação. A atualização frequente da lista de exames e dos intervalos de valores críticos com base na revisão da literatura e na troca de experiências entre os laboratórios clínicos garante o processo de melhoria contínua para esse procedimento e a segurança do paciente.

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INTRODUCTION: The application of the Lean methodology in health institutions is an effective tool to improve the capacity and workflow, as well as to increase the level of satisfaction of patients and employees. OBJECTIVE: To optimise the time of outpatient care in a clinical laboratory, by implementing a methodology based on the organisation of operational procedures to improve user satisfaction and reduce the number of complaints for delays in care. MATERIAL AND METHODS: A quasi-experimental before and after study was conducted between October 2011 to September 2012. XBar and S charts were used to observe the mean service times and standard deviation. The user satisfaction was assessed using service questionnaires. RESULTS: A reduction of 17 minutes was observed in the time of patient care from arrival to leaving the laboratory, and a decrease of 60% in complaints of delay in care. Despite the high staff turnover and 38% increase in the number of patients seen, a culture of empowerment and continuous improvement was acquired, as well as greater efficiency and productivity in the care process, which was reflected by maintaining standards 12 months after implementation. CONCLUSION: Lean is a viable methodology for clinical laboratory procedures, improving their efficiency and effectiveness.

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Although it is not rare to find sputum that is positive acid-fast bacilli (AFB) smear but subsequent culture fails to isolate mycobacteria in clinical practice, the incidence and clinical implication of those sputa from new patients has not been clearly elucidated. The aim of this study was to determine the incidence and clinical implication of sputum with positive AFB smear but negative in mycobacterial culture. All sputa that were positive AFB smear requested during diagnostic work up for new patients visiting Seoul National University Hospital from 1 January 2005 through 31 December 2006 were included. Sputa producing a positive AFB smear but negative mycobacterial culture were classified into one of four categories: laboratory failure to isolate mycobacteria, false positive AFB smear, pathogen may show a positive AFB smear other than mycobacteria, and indeterminate results. Out of 447 sputa with a positive AFB smear, 29 (6.5%) failed to culture any organism. Among these 29 sputa, 18 were caused by laboratory failure to isolate mycobacteria, six were false positive smears, and five indeterminate. Although most sputum with a positive AFB smear but negative culture could be classified as a laboratory failure, clinicians should consider the possibility of false positive AFB smear.

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