RESUMO
This study includes clinical laboratories that participated in the first general chemistry proficiency testing survey in 2022 to assess awareness and adoption of new equations from the Chronic Kidney Disease Epidemiology Collaboration for estimated glomerular filtration rate (eGFR) that eliminated race-adjustment factors, including one based on creatinine and one based on creatinine and cystatin C.
Assuntos
Serviços de Laboratório Clínico , Taxa de Filtração Glomerular , Fidelidade a Diretrizes , Laboratórios Clínicos , Serviços de Laboratório Clínico/normas , Creatinina , Laboratórios Clínicos/normas , Estados Unidos , Conhecimentos, Atitudes e Prática em SaúdeRESUMO
BACKGROUND: The COVID-19 pandemic has had a profound worldwide impact. Vietnam, a lower middle-income country with limited resources, has successfully slowed this pandemic. The objectives of this report are to explore the impact of the COVID-19 pandemic on the research activities of an ongoing hypertension trial using a storytelling intervention in Vietnam. METHODS: Data were collected in a mixed-methods study among 86 patients and 10 health care workers participating in a clinical trial designed to improve hypertension control. Several questions related to the impact of COVID-19 on patient's daily activities and adherence to the study interventions were included in the follow-up visits. A focus group discussion was conducted among health care workers to discuss the impact of COVID-19 on research related activities. RESULTS: Fewer patients in the intervention group reported that they faced difficulties in adhering to prescribed study interventions, wanted to receive a call from a dedicated hotline, or have a visit from a community health worker as compared with those in the comparison group. Most study patients are willing to participate in future health research studies. When asked about the potential use of mobile phones in health research studies, fewer patients in the intervention group felt comfortable using a mobile phone for the delivery of intervention and interviews compared with those in the comparison condition. Community health workers shared that they visited patient's homes more often than previously due to the pandemic and health care workers had to perform more virus containment activities without a corresponding increase in ancillary staff. CONCLUSIONS: Both patients and health care workers in Vietnam faced difficulties in adhering to recommended trial interventions and procedures. Multiple approaches for intervention delivery and data collection are needed to overcome these difficulties during future health crises and enhance the implementation of future research studies. TRIAL REGISTRATION: ClinicalTrials.gov. Registration number: https://clinicaltrials.gov/ct2/show/NCT03590691 (registration date July 17, 2018).
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COVID-19/epidemiologia , Serviços de Laboratório Clínico/normas , Ensaios Clínicos como Assunto , Pessoal de Laboratório Médico/psicologia , Pacientes/psicologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Serviços de Laboratório Clínico/estatística & dados numéricos , Feminino , Humanos , Hipertensão/epidemiologia , Masculino , Pessoa de Meia-Idade , Cooperação do Paciente , VietnãRESUMO
BACKGROUND: The coronavirus disease 2019 (COVID 19) is a zoonotic viral infection that originated in Wuhan, China, in December 2019. It was declared a pandemic by the World Health Organization shortly thereafter. This pandemic is going to have a lasting impact on the functioning of pathology laboratories due to the frequent handling of potentially infectious samples by the laboratory personnel. To deal with this unprecedented situation, various national and international guidelines have been put forward outlining the precautions to be taken during sample processing from a potentially infectious patient. PURPOSE: Most of these guidelines are centered around laboratories that are a part of designated COVID 19 hospitals. However, proper protocols need to be in place in all laboratories, irrespective of whether they are a part of COVID 19 hospital or not as this would greatly reduce the risk of exposure of laboratory/hospital personnel. As part of a laboratory associated with a rural cancer hospital which is not a dedicated COVID 19 hospital, we aim to present our institute's experience in handling pathology specimens during the COVID 19 era. CONCLUSION: We hope this will address the concerns of small to medium sized laboratories and help them build an effective strategy required for protecting the laboratory personnel from risk of exposure and also ensure smooth and optimum functioning of the laboratory services.
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COVID-19/diagnóstico , Serviços de Laboratório Clínico/organização & administração , Controle de Infecções/organização & administração , Transmissão de Doença Infecciosa do Paciente para o Profissional/prevenção & controle , Centros de Atenção Terciária/organização & administração , COVID-19/epidemiologia , COVID-19/transmissão , COVID-19/virologia , Institutos de Câncer/organização & administração , Institutos de Câncer/normas , Serviços de Laboratório Clínico/normas , Descontaminação/métodos , Descontaminação/normas , Países em Desenvolvimento , Desinfecção/métodos , Desinfecção/organização & administração , Desinfecção/normas , Hospitais Rurais/organização & administração , Hospitais Rurais/normas , Humanos , Índia/epidemiologia , Controle de Infecções/normas , Pessoal de Laboratório Médico/organização & administração , Pessoal de Laboratório Médico/normas , Pandemias/prevenção & controle , SARS-CoV-2/isolamento & purificação , SARS-CoV-2/patogenicidade , Manejo de Espécimes/normas , Centros de Atenção Terciária/normas , Recursos Humanos/organização & administração , Recursos Humanos/normasRESUMO
ABSTRACT: Medical diagnosis and therapy often rely on laboratory testing. We observed mistaken testing in evaluations for hemophagocytic lymphohistiocytosis (HLH) that led to delays and adverse outcomes. Physicians were mistakenly ordering interleukin-2 and quantitative natural killer cell flow cytometry, rather than soluble interleukin 2 receptor (sIL2R) or qualitative natural killer functional tests in the evaluation of patients suspected to have HLH.We initiated a prospective quality improvement project to reduce mistaken testing, reduce delays in correct testing due to mistaken ordering, and improve HLH evaluations. This consisted of provider education, developing an evaluation algorithm, and ultimately required systems interventions such as pop-ups and removal of the mistaken tests from the electronic ordering catalog.Active education reduced mistaken testing significantly in HLH evaluations from baseline (73.3% vs 33.3%, Pâ=â.003, relative risk reduction (RRR) 54.5%), but failed to meet the pre-specified RRR cutoff for success (70%). Education alone did not significantly reduce the proportion of HLH evaluations with delays in sIL2R testing (23.3% vs 7.4%, Pâ=â.096). Mistaken testing increased after the active intervention ended (33.3% vs 43.5%, Pâ=â.390, with RRR 40.7% from baseline. Mistaken test removal was successful: mistaken testing dropped to 0% (Pâ<â.001, RRR 100%), saved $14,235 yearly, eliminated delays in sIL2R testing from mistaken testing (23.3% vs 0%, Pâ=â.008), and expedited sIL2R testing after admission for HLH symptoms (14.6âdays vs 3.8âdays, Pâ=â.0012). These data show systems controls are highly effective in quality improvement while education has moderate efficacy.
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Serviços de Laboratório Clínico/normas , Erros de Diagnóstico , Linfo-Histiocitose Hemofagocítica/diagnóstico , Melhoria de Qualidade/organização & administração , Erros de Diagnóstico/prevenção & controle , Erros de Diagnóstico/estatística & dados numéricos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação das Necessidades , Avaliação de Resultados em Cuidados de Saúde , Risco Ajustado/métodos , Risco Ajustado/organização & administração , Desenvolvimento de Pessoal/métodos , Desenvolvimento de Pessoal/organização & administração , Tempo para o Tratamento/estatística & dados numéricosRESUMO
BACKGROUND: Before public health emergencies became a major challenge worldwide, the scope of laboratory management was only related to developing, maintaining, improving, and sustaining the quality of accurate laboratory results for improved clinical outcomes. Indeed, quality management is an especially important aspect and has achieved great milestones during the development of clinical laboratories. CURRENT STATUS: However, since the coronavirus disease 2019 (COVID-19) pandemic continues to be a threat worldwide, previous management mode inside the separate laboratory could not cater to the demand of the COVID-19 public health emergency. Among emerging new issues, the prominent challenges during the period of COVID-19 pandemic are rapid-launched laboratory-developed tests (LDTs) for urgent clinical application, rapid expansion of testing capabilities, laboratory medicine resources, and personnel shortages. These related issues are now impacting on clinical laboratory and need to be effectively addressed. CONCLUSION: Different from traditional views of laboratory medicine management that focus on separate laboratories, present clinical laboratory management must be multidimensional mode which should consider consolidation of the efficient network of regional clinical laboratories and reasonable planning of laboratories resources from the view of overall strategy. Based on relevant research and our experience, in this review, we retrospect the history trajectory of laboratory medicine management, and also, we provide existing and other feasible recommended management strategies for laboratory medicine in future.
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Teste para COVID-19 , COVID-19/diagnóstico , Serviços de Laboratório Clínico , Técnicas de Laboratório Clínico/normas , Laboratórios , Serviços de Laboratório Clínico/organização & administração , Serviços de Laboratório Clínico/normas , Humanos , Laboratórios/organização & administração , Laboratórios/normas , Testes Imediatos , Saúde Pública , Garantia da Qualidade dos Cuidados de SaúdeRESUMO
BACKGROUND: To utilize the external quality assessment (EQA)/proficiency testing (PT) scheme to evaluate the equivalence of different clinical enzymatic measuring systems in Beijing. METHODS: The Beijing Center for Clinical Laboratory (BCCL) distributed three investigation samples to mutual recognition clinical laboratories in Beijing including alanine aminotransferase (ALT), aspartate aminotransferase (AST), γ-glutamyltransferase (GGT), creatine kinase (CK), and lactate dehydrogenase (LDH). These samples were derived from serum pools with values assigned by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) enzymatic reference measurement procedures (RMPs). Each laboratory performed duplicate tests of the samples. Then, the samples at level 1 were used to recalibrate individual measuring systems for repeating the tests. BCCL collected data for evaluation of their analytical quality. RESULTS: Before recalibration, the biases of ALT and AST tests were not traceable to the IFCC RMPs, and the bias pass rates of GGT, CK, and LDH tests were only 51.2%, 55.7%, and 48.6% respectively. After recalibration, the pass rates of ALT, AST, GGT, CK, and LDH increased to 95.1%, 82.9%, 95.1%, 97.1%, and 70.0% respectively. The EQA/PT also showed that after recalibration, more than 95% of laboratories met the optimum level specifications of the biological variation for ALT, AST, GGT, and CK tests and the desirable for LDH tests. CONCLUSION: The enzymatic tests in Beijing need to be further standardized by category 1 or 2 EQA/PT scheme for mutual recognition between clinical laboratories. The criteria of biological variation are more relevant for determining the equivalence of clinical enzymatic tests.
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Alanina Transaminase/sangue , Aspartato Aminotransferases/sangue , Ensaios Enzimáticos Clínicos/normas , Creatina Quinase/sangue , L-Lactato Desidrogenase/sangue , Laboratórios/normas , gama-Glutamiltransferase/sangue , Pequim , Serviços de Laboratório Clínico/normas , Humanos , Ensaio de Proficiência Laboratorial/métodos , Garantia da Qualidade dos Cuidados de Saúde/normasRESUMO
OBJECTIVES: Autoverification is the process of evaluating and validating laboratory results using predefined computer-based algorithms without human interaction. By using autoverification, all reports are validated according to the standard evaluation criteria with predefined rules, and the number of reports per laboratory specialist is reduced. However, creating and validating these rules are the most demanding steps for setting up an autoverification system. In this study, we aimed to develop a model for helping users establish autoverification rules and evaluate their validity and performance. DESIGN & METHODS: The proposed model was established by analyzing white papers, previous study results, and national/international guidelines. An autoverification software (myODS) was developed to create rules according to the model and to evaluate the rules and autoverification rates. The simulation results that were produced by the software were used to demonstrate that the determined framework works as expected. Both autoverification rates and step-based evaluations were performed using actual patient results. Two algorithms defined according to delta check usage (Algorithm A and B) and three review limits were used for the evaluation. RESULTS: Six hundred seventeen rules were created according to the proposed model. 1,976 simulation results were created for validation. Our results showed that manual review limits are the most critical step in determining the autoverification rate, and delta check evaluation is especially important for evaluating inpatients. Algorithm B, which includes consecutive delta check evaluation, had higher AV rates. CONCLUSIONS: Systemic rule formation is a critical factor for successful AV. Our proposed model can help laboratories establish and evaluate autoverification systems. Rules created according to this model could be used as a starting point for different test groups.
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Automação Laboratorial/métodos , Sistemas de Informação em Laboratório Clínico/normas , Serviços de Laboratório Clínico/normas , Laboratórios Hospitalares/normas , Algoritmos , Simulação por Computador , Técnicas de Apoio para a Decisão , Modelos Teóricos , Controle de Qualidade , Validação de Programas de ComputadorRESUMO
Before a new method is used for clinical testing, it is essential that it is evaluated for suitability for its intended purpose. This document gives guidance for the performance, verification and implementation processes required by regulatory and accreditation bodies. It covers the planning and verification of specialist haemostatic tests, including factor assays, D-dimers, direct anticoagulants and thrombophilia testing.
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Testes Hematológicos/normas , Hemostasia , Animais , Anticoagulantes/análise , Fatores de Coagulação Sanguínea/análise , Calibragem , Serviços de Laboratório Clínico/normas , Produtos de Degradação da Fibrina e do Fibrinogênio/análise , Testes Hematológicos/métodos , Humanos , Padrões de Referência , Trombofilia/sangue , Trombofilia/diagnósticoRESUMO
Clinical examination has become an important method of disease diagnosis, curative effect evaluation, prognosis judgment and health monitoring, and the biological reference interval is the reference standard to interpret test results and analyses of test information. In clinical tests, the reference interval is often affected by race, sex, age, geographical location and growth and development, so it is very important to establish a suitable reference interval for each laboratory. It is a huge and arduous task for each laboratory to establish its own reference interval. It is unrealistic for different measurement systems to establish reference intervals. According to the C28-A3c guideline from the Clinical and Laboratory Standards Institute (CLSI), clinical laboratories can appropriately transfer the reference intervals provided by other laboratories. This paper reviews whether the biomarkers in multiregional laboratories can transfer reference intervals between different measurement systems to expand the application of reference interval databases and ensure the accuracy and consistency of the test results.
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Biomarcadores/análise , Serviços de Laboratório Clínico/normas , Canadá , Humanos , Valores de ReferênciaRESUMO
To effectively implement the Canadian Cardiovascular Society (CCS) guidelines for dyslipidemia management into clinical laboratories, clear recommendations for lipid reporting are essential. In this study, the Canadian Society of Clinical Chemists Working Group on Reference Interval Harmonisation surveyed Canadian laboratories on adult lipid reporting practices to set a foundation for the development and implementation of harmonised lipid reporting across Canada. Key aspects of the survey asked laboratories: what reporting parameters were in place to assess lipid results; what interpretative comments were provided; whether nonfasting lipids were permitted and, if so, what strategy was used to document fasting status; and whether there was interest in implementing a harmonised lipid report. A total of 101 laboratories were represented by 24 respondents, as many responses were submitted by laboratory networks that included more than 1 laboratory. There was at least 1 response from 9 Canadian provinces and representation across 5 testing platforms. Upper and lower limits for lipid parameters and referenced source of limits varied substantially across laboratories, with only 56% of laboratories (9 respondents) referencing the 2016 CCS guidelines. Eighty-six percent of laboratories (19 respondents) report nonfasting lipids, although the method of documenting nonfasting status varied. Overall, 36% of laboratories (8 respondents) reported interest in implementing a harmonised lipid report. Assessment of current lipid-reporting practices supports the need for harmonised lipid reporting across Canada. Development of a harmonised lipid report for the adult population, consistent with up-to-date Canadian guidelines, will improve continuity of lipid test interpretation across Canada and improve clinical decision making.
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Serviços de Laboratório Clínico , Dislipidemias , Lipídeos , Administração dos Cuidados ao Paciente , Canadá/epidemiologia , Serviços de Laboratório Clínico/organização & administração , Serviços de Laboratório Clínico/normas , Dislipidemias/sangue , Dislipidemias/epidemiologia , Dislipidemias/terapia , Necessidades e Demandas de Serviços de Saúde , Humanos , Lipídeos/análise , Lipídeos/sangue , Administração dos Cuidados ao Paciente/métodos , Administração dos Cuidados ao Paciente/normas , Melhoria de Qualidade , Padrões de Referência , Valores de Referência , Projetos de PesquisaRESUMO
INTRODUCTION: The Bethesda System for Reporting Thyroid Cytopathology was developed in 2007 to facilitate an accurate, reproducible communication of thyroid fine-needle aspiration (FNA) interpretations between clinicians and cytopathologists and to serve as a guide for treatment. Based on large patient series, the system details the risk of malignancy for each category as well as a suggested management for each FNA result. Though this system has been widely adopted, there are only few studies to determine whether results are applicable for Israel. METHODS: A multicenter, retrospective analysis of medical charts of all patients who underwent thyroid surgery between January 1st, 2012 and December 31st, 2016 in four medical centers in Israel was performed. Data was analyzed for the overall risk of malignancy for the Bethesda system groups as well as comparison between the different laboratories performing the test. RESULTS: Records of 810 thyroidectomies in which preoperative cytological reports and final pathology were available and reviewed. The malignancy rates according to the Bethesda groups' I-VI for our cohort were: 27.8%, 17.6%, 41.4%, 41.4%, 86.9%, and 98.1% respectively. Similar results were seen when results were analyzed according to the different laboratories performing the tests. CONCLUSIONS: Post-surgical review of all Bethesda groups had higher malignancy rates than those reported in the original report. These results indicate a difference in the malignancy rates for the different Bethesda system groups in Israel compared to those reported. Physicians are encouraged to use data validated for their own country or patients' community in addition to published values.
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Biópsia por Agulha Fina , Neoplasias da Glândula Tireoide/patologia , Neoplasias da Glândula Tireoide/cirurgia , Adulto , Idoso , Serviços de Laboratório Clínico/normas , Serviços de Laboratório Clínico/estatística & dados numéricos , Transtornos de Deglutição/etiologia , Dispneia/etiologia , Feminino , Humanos , Israel , Linfadenopatia/etiologia , Masculino , Pessoa de Meia-Idade , Seleção de Pacientes , Valor Preditivo dos Testes , Estudos Retrospectivos , Fatores de Risco , Avaliação de Sintomas , Glândula Tireoide/patologia , Neoplasias da Glândula Tireoide/classificação , Neoplasias da Glândula Tireoide/diagnóstico por imagem , Tireoidectomia , Carga Tumoral , UltrassonografiaRESUMO
BACKGROUND: Blood cultures are one of the most important tests performed by microbiology laboratories. Many hospitals, particularly in low and middle-income countries, lack either microbiology services or staff to provide 24 h services resulting in delays to blood culture incubation. There is insufficient guidance on how to transport/store blood cultures if delays before incubation are unavoidable, particularly if ambient temperatures are high. This study set out to address this knowledge gap. METHODS: In three South East Asian countries, four different blood culture systems (two manual and two automated) were used to test blood cultures spiked with five common bacterial pathogens. Prior to incubation the spiked blood culture bottles were stored at different temperatures (25 °C, in a cool-box at ambient temperature, or at 40 °C) for different lengths of time (0 h, 6 h, 12 h or 24 h). The impacts of these different storage conditions on positive blood culture yield and on time to positivity were examined. RESULTS: There was no significant loss in yield when blood cultures were stored < 24 h at 25 °C, however, storage for 24 h at 40 °C decreased yields and longer storage times increased times to detection. CONCLUSION: Blood cultures should be incubated with minimal delay to maximize pathogen recovery and timely result reporting, however, this study provides some reassurance that unavoidable delays can be managed to minimize negative impacts. If delays to incubation ≥ 12 h are unavoidable, transportation at a temperature not exceeding 25 °C, and blind sub-cultures prior to incubation should be considered.
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Hemocultura/normas , Manejo de Espécimes/normas , Sudeste Asiático , Bactérias/classificação , Bactérias/isolamento & purificação , Hemocultura/estatística & dados numéricos , Serviços de Laboratório Clínico/normas , Serviços de Laboratório Clínico/estatística & dados numéricos , Humanos , Manejo de Espécimes/estatística & dados numéricos , Temperatura , Fatores de TempoRESUMO
CONTEXT: An audit aims to verify conformance to required processes, assess their implementation, and define the targets of quality control. AIMS: To evaluate preanalytic and analytic phases of surgical histopathology in a tertiary healthcare center. SETTING AND DESIGN: An observational retrospective and prospective study over 3 months each of year 2013 and 2014. MATERIALS AND METHODS: Biopsy, small resections, large organ resections, bone marrow aspirate/biopsy (BMA/BMB), and frozen section samples received in surgical histopathology were categorized as I to V, respectively. A manual audit was done for preanalytical phase (adequacy of clinical information and grossing adequacy) and analytical phase [turnaround time (TAT) and tissue section quality]. STATISTICAL ANALYSIS: Qualitative data was assessed by Chi-Square test. Quantitative data was assessed using One-Way Analysis of Variance. RESULTS: Among 3179 total cases, category I to V had 1558 (49%), 1099 (34.6%), 342 (10.8%), 124 (3.8%), and 56 (1.8%) cases, respectively. Category I had shortest TAT but maximum number of inadequately sent specimens and recuts. Category III had maximum cases with inadequate clinical history, grossing errors, additional sections, and longest TAT. Category IV had maximum cases with poor quality sections. Category V had maximum cases with inadequate demographic details and clinical investigations. BMB (114, 91.9%) was more useful than BMA for diagnosis. Mean TAT for fixed tissues and frozen tissues was 3.6 ± 1.8 days and 26.6 ± 11.2 min, respectively. CONCLUSIONS: Total 25% of annual workload was studied by an observational, manual audit. Quality indicators were achieved as per international norms despite limited resources. Remedial actions were suggested for technicians, clinicians, and pathologists to minimize errors.
Assuntos
Serviços de Laboratório Clínico/normas , Técnicas de Laboratório Clínico/normas , Patologia Cirúrgica/normas , Centros de Atenção Terciária/estatística & dados numéricos , Biópsia , Serviços de Laboratório Clínico/estatística & dados numéricos , Técnicas de Laboratório Clínico/métodos , Feminino , Humanos , Pessoal de Laboratório Médico/educação , Pessoal de Laboratório Médico/normas , Patologia Cirúrgica/métodos , Patologia Cirúrgica/estatística & dados numéricos , Estudos Prospectivos , Controle de Qualidade , Estudos RetrospectivosRESUMO
BACKGROUND: Reporting critical results in a timely manner is a crucial role of clinical laboratories. Traditionally, these results were reported using the phone or fax system. However, there are now other modes of communication for this reporting. Quality improvement in any organization is driven by detection of errors and benchmarking against peers. In the case of critical result reporting, there are few current widely used Benchmarking schemes. METHODS: The Roche Clinical Chemistry Benchmarking Survey in 2019 added questions about critical result reporting including the mode of communication and turnaround time key performance index. This survey includes over 1100 laboratories from 20 countries. RESULTS: The survey revealed a range of communication strategies with phone calls still the commonest followed by email. The key performance index for most laboratories was less than 10 min. CONCLUSION: Benchmarking can provide key information for quality improvement activities, particularly pre- and postanalytical.
Assuntos
Benchmarking/métodos , Serviços de Laboratório Clínico/normas , Técnicas de Laboratório Clínico/normas , Comunicação , Química Clínica/normas , Técnicas de Laboratório Clínico/métodos , Troca de Informação em Saúde/normas , Humanos , Laboratórios/normas , Controle de Qualidade , Melhoria de Qualidade , Inquéritos e Questionários , Fatores de TempoRESUMO
External quality assessment (EQA) is important for evaluating clinical laboratories and enhancing their testing quality. EQA schemes are variable; thus, it is crucial that the EQA organizers share their experiences to continuously improve the EQA scheme. The Korean Association of External Quality Assessment Service (KEQAS) has been the leading, authorized EQA institute for the standardization and quality management of laboratory testing in Korean medical institutions since 1976. The EQA scheme underwent a major change in 2016, and the number of EQA programs increased significantly since then. The key changes implemented in EQA scheme include a fully computerized assessment to accelerate feedback and unification of the testing and reporting methods. We provide an overview of the EQA schemes and performance evaluation criteria of the KEQAS and suggest directions for achieving the global harmonization of EQA.