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1.
JAMA Netw Open ; 3(7): e207750, 2020 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-32697323

RESUMO

Importance: Administrative databases may offer efficient clinical data collection for studying epidemiology, outcomes, and temporal trends in health care delivery. However, such data have seldom been validated against microbiological laboratory results. Objective: To assess the validity of International Classification of Diseases, Ninth Revision (ICD-9) organism-specific administrative codes for pneumonia using microbiological data (test results for blood or respiratory culture, urinary antigen, or polymerase chain reaction) as the criterion standard. Design, Setting, and Participants: Cross-sectional diagnostic accuracy study conducted between February 2017 and June 2019 using data from 178 US hospitals in the Premier Healthcare Database. Patients were aged 18 years or older admitted with pneumonia and discharged between July 1, 2010, and June 30, 2015. Data were analyzed from February 14, 2017, to June 27, 2019. Exposures: Organism-specific pneumonia identified from ICD-9 codes. Main Outcomes and Measures: Sensitivity, specificity, positive predictive value, and negative predictive value of ICD-9 codes using microbiological data as the criterion standard. Results: Of 161 529 patients meeting inclusion criteria (mean [SD] age, 69.5 [16.2] years; 51.2% women), 35 759 (22.1%) had an identified pathogen. ICD-9-coded organisms and laboratory findings differed notably: for example, ICD-9 codes identified only 14.2% and 17.3% of patients with laboratory-detected methicillin-sensitive Staphylococcus aureus and Escherichia coli, respectively. Although specificities and negative predictive values exceeded 95% for all codes, sensitivities ranged downward from 95.9% (95% CI, 95.3%-96.5%) for influenza virus to 14.0% (95% CI, 8.8%-20.8%) for parainfluenza virus, and positive predictive values ranged downward from 91.1% (95% CI, 89.5%-92.6%) for Staphylococcus aureus to 57.1% (95% CI, 39.4%-73.7%) for parainfluenza virus. Conclusions and Relevance: In this study, ICD-9 codes did not reliably capture pneumonia etiology identified by laboratory testing; because of the high specificities of ICD-9 codes, however, administrative data may be useful in identifying risk factors for resistant organisms. The low sensitivities of the diagnosis codes may limit the validity of organism-specific pneumonia prevalence estimates derived from administrative data.


Assuntos
Hospitalização/estatística & dados numéricos , Classificação Internacional de Doenças/normas , Técnicas Microbiológicas , Pneumonia , Idoso , Estudos Transversais , Bases de Dados Factuais/estatística & dados numéricos , Feminino , Humanos , Pacientes Internados/estatística & dados numéricos , Masculino , Técnicas Microbiológicas/métodos , Técnicas Microbiológicas/normas , Pessoa de Meia-Idade , Pneumonia/epidemiologia , Pneumonia/etiologia , Pneumonia/microbiologia , Pneumonia/terapia , Valor Preditivo dos Testes , Sensibilidade e Especificidade , Estados Unidos/epidemiologia
2.
Front Public Health ; 8: 258, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32656174

RESUMO

Background: Access to clinical bacteriology in low resource settings (LRS) is a key bottleneck preventing individual patient management of treatable severe infections, detection of antimicrobial resistance (AMR), and implementation of effective stewardship interventions. We sought to demonstrate the feasibility of a practical bundle of interventions aimed at implementing sustainable clinical bacteriology services at Tikur Anbessa Specialized Hospital in Addis Ababa, Ethiopia, and report on cost and intensity of supervision. Methods: Starting in Dec 2015, an intervention based on the CLSI QMS01-A guideline was established, consisting of (i) an initial needs assessment, (ii) development of key standard operating procedures, (iii) adaptation of processes for LRS, (iv) training and supervision of laboratory staff via consultant visits and existing online resources, and (v) implementation of a practical quality systems approach. A guiding principle of the bundle was sustainability of all interventions post implementation. Outcomes and challenges: An initial investment of ~US$ 26,200 for laboratory reagents, and a total of 50 visit-days per year from three Canadian and Norwegian microbiologists were committed. Twelve SOPs, including antimicrobial susceptibility testing, were adapted, and an automated blood culture platform was donated (bioMerieux). In the first 18 months of implementation of the intervention, the average volume of specimens analyzed in the lab went from 15/day to 75/day. The number of blood cultures tested increased from an average of 2/day to over 45/day. Antimicrobial susceptibility testing was introduced and cumulative antibiograms were generated for the institution. Quality control was implemented for all procedures and quality assurance tools implemented included external quality assurance and proficiency testing of six technologists with longitudinal follow-up. The laboratory is on the path toward SLIPTA accreditation by the African Society for Laboratory Medicine. Reagent costs, staff training and retention, and engagement of clinical personnel with the lab proved to be manageable challenges. Key external challenges include in-country supply-chain management issues, lack of competition among distributors, and foreign-currency exchange distortions. Conclusions: Using a relatively low-intensity intervention based on existing training tools and accreditation schemes, we demonstrate that establishment of reasonable-quality clinical bacteriology is not only within reach but also a critical step toward assessing the burden of AMR in settings like this one and implementing effective stewardship strategies.


Assuntos
Gestão de Antimicrobianos , Bacteriologia , Laboratórios Hospitalares/normas , Pessoal de Laboratório/educação , Garantia da Qualidade dos Cuidados de Saúde , Acreditação , Bacteriologia/normas , Países em Desenvolvimento , Etiópia , Estudos de Viabilidade , Humanos , Laboratórios Hospitalares/economia , Técnicas Microbiológicas/normas , Técnicas Microbiológicas/estatística & dados numéricos , Encaminhamento e Consulta
3.
Int J Mycobacteriol ; 9(1): 29-33, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32474485

RESUMO

Background: The external quality assessment (EQA) or external quality control is an evaluation conducted by a certified external organization to inquire about the quality of the results provided by a laboratory. The primary role of EQA is to verify the accuracy of laboratory results. This is essential in research because research data should be published in international peer-reviewed journals, and laboratory results must be repeatable. In 2007, the University Clinical Research Center (UCRC's) biosafety level 3 (BSL-3) laboratory joined the EQA program with the College of American Pathologists in acid-fast staining and culture and identification of mycobacteria as per laboratory accreditation preparedness. Thus, after 11 years of participation, the goal of our study was to evaluate the performance of our laboratory during the different interlaboratory surveys. Methods: We conducted a descriptive retrospective study to evaluate the results of UCRC mycobacteriology laboratory from surveys conducted during 2007 and 2017. Results: Of the 22 evaluations, the laboratory had satisfactory (100% of concordance results) in 18 (81.8%) and good (80% of concordance results) in 4 (18.2%). Overall, the laboratory was above the commended/accepted limits of 75%. Conclusion: So far, UCRC's BSL-3 performed well during the first 11 years of survey participation, and efforts should be deployed to maintain this high quality in the preparedness for laboratory accreditation and support to clinical trials.


Assuntos
Acreditação , Ensaios Clínicos como Assunto , Contenção de Riscos Biológicos/normas , Laboratórios/normas , Estudos Transversais , Humanos , Mali , Técnicas Microbiológicas/métodos , Técnicas Microbiológicas/normas , Mycobacterium/crescimento & desenvolvimento , Mycobacterium/isolamento & purificação , Garantia da Qualidade dos Cuidados de Saúde/normas , Estudos Retrospectivos , Coloração e Rotulagem , Tuberculose/diagnóstico , Tuberculose/microbiologia
4.
Med Mycol ; 58(8): 1015-1028, 2020 Nov 10.
Artigo em Inglês | MEDLINE | ID: mdl-32400869

RESUMO

Pneumocystis jirovecii can cause life-threatening pneumonia in immunocompromised patients. Traditional diagnostic testing has relied on staining and direct visualization of the life-forms in bronchoalveolar lavage fluid. This method has proven insensitive, and invasive procedures may be needed to obtain adequate samples. Molecular methods of detection such as polymerase chain reaction (PCR), loop-mediated isothermal amplification (LAMP), and antibody-antigen assays have been developed in an effort to solve these problems. These techniques are very sensitive and have the potential to detect Pneumocystis life-forms in noninvasive samples such as sputum, oral washes, nasopharyngeal aspirates, and serum. This review evaluates 100 studies that compare use of various diagnostic tests for Pneumocystis jirovecii pneumonia (PCP) in patient samples. Novel diagnostic methods have been widely used in the research setting but have faced barriers to clinical implementation including: interpretation of low fungal burdens, standardization of techniques, integration into resource-poor settings, poor understanding of the impact of host factors, geographic variations in the organism, heterogeneity of studies, and limited clinician recognition of PCP. Addressing these barriers will require identification of phenotypes that progress to PCP and diagnostic cut-offs for colonization, generation of life-form specific markers, comparison of commercial PCR assays, investigation of cost-effective point of care options, evaluation of host factors such as HIV status that may impact diagnosis, and identification of markers of genetic diversity that may be useful in diagnostic panels. Performing high-quality studies and educating physicians will be crucial to improve the rates of diagnosis of PCP and ultimately to improve patient outcomes.


Assuntos
Técnicas Microbiológicas/métodos , Pneumocystis carinii/isolamento & purificação , Pneumonia por Pneumocystis/diagnóstico , Humanos , Imunoensaio , Hospedeiro Imunocomprometido , Técnicas Microbiológicas/economia , Técnicas Microbiológicas/normas , Técnicas Microbiológicas/tendências , Pneumocystis carinii/citologia , Pneumocystis carinii/fisiologia , Pneumonia por Pneumocystis/epidemiologia , Pneumonia por Pneumocystis/prevenção & controle , Reação em Cadeia da Polimerase , Sensibilidade e Especificidade , Manejo de Espécimes , Coloração e Rotulagem
5.
Clin Microbiol Infect ; 25(9): 1086-1095, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31039443

RESUMO

BACKGROUND: Microbial whole genome sequencing (WGS) has many advantages over standard microbiological methods. However, it is not yet widely implemented in routine hospital diagnostics due to notable challenges. OBJECTIVES: The aim was to extract managerial, financial and clinical criteria supporting the decision to implement WGS in routine diagnostic microbiology, across different operational models of implementation in the hospital setting. METHODS: This was a systematic review of literature identified through PubMed and Web of Science. English literature studies discussing the applications of microbial WGS without limitation on publication date were eligible. A narrative approach for categorization and synthesis of the sources identified was adopted. RESULTS: A total of 98 sources were included. Four main alternative operational models for incorporating WGS in clinical microbiology laboratories were identified: full in-house sequencing and analysis, full outsourcing of sequencing and analysis and two hybrid models combining in-house/outsourcing of the sequencing and analysis components. Six main criteria (and multiple related sub-criteria) for WGS implementation emerged from our review and included cost (e.g. the availability of resources for capital and operational investment); manpower (e.g. the ability to provide training programmes or recruit trained personnel), laboratory infrastructure (e.g. the availability of supplies and consumables or sequencing platforms), bioinformatics requirements (e.g. the availability of valid analysis tools); computational infrastructure (e.g. the availability of storage space or data safety arrangements); and quality control (e.g. the existence of standardized procedures). CONCLUSIONS: The decision to incorporate WGS in routine diagnostics involves multiple, sometimes competing, criteria and sub-criteria. Mapping these criteria systematically is an essential stage in developing policies for adoption of this technology, e.g. using a multicriteria decision tool. Future research that will prioritize criteria and sub-criteria that were identified in our review in the context of operational models will inform decision-making at clinical and managerial levels with respect to effective implementation of WGS for routine use. Beyond WGS, similar decision-making challenges are expected with respect to future integration of clinical metagenomics.


Assuntos
Doenças Transmissíveis/diagnóstico , Testes Diagnósticos de Rotina/normas , Técnicas Microbiológicas/normas , Sequenciamento Completo do Genoma/normas , Técnicas de Apoio para a Decisão , Testes Diagnósticos de Rotina/economia , Testes Diagnósticos de Rotina/instrumentação , Humanos , Metagenômica , Técnicas Microbiológicas/economia , Técnicas Microbiológicas/instrumentação , Controle de Qualidade , Sequenciamento Completo do Genoma/economia , Sequenciamento Completo do Genoma/instrumentação
6.
J Appl Microbiol ; 126(6): 1944-1954, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30884047

RESUMO

AIMS: To evaluate a low-cost water quality test for at-scale drinking water safety estimation in rural India. METHODS AND RESULTS: Within a longitudinal study to characterize variability in household drinking water safety in rural Maharashtra, we piloted a low-cost presence-absence (LCPA) microbial test designed to be used by volunteer residents in rural areas. In comparing the LCPA results with standard laboratory methods for enumeration of Escherichia coli, we found that LCPA tests using modified mTec media were highly sensitive in detecting drinking water of moderate risk (88% of tests were positive at E. coli counts of 11-100 CFU per 100 ml) and high risk (96% of tests were positive at E. coli counts of 101 + CFU per 100 ml). The LCPA tests demonstrated low specificity for E. coli specifically, due to concurrent detection of Klebsiella: 38% of LCPA tests were positive even when E. coli was not detected in a 100 ml sample by membrane filtration, suggesting the test would be conservative in risk estimation. We also found that 47% of participants in rural villages in India were willing to conduct tests and return results after a brief training, with 45% of active participants sending their water testing results via short message service. CONCLUSIONS: Given their low cost (~US$0.50 as piloted) and open-source format, such tests may provide a compelling alternative to standard methods for rapid water quality assessments, especially in resource-limited settings. SIGNIFICANCE AND IMPACT OF THE STUDY: The lack of availability of water quality data constrains efforts to monitor, evaluate and improve the safety of water and sanitation infrastructure in underserved settings. Current water testing methods are not scalable because of laboratory and cost constraints. Our findings indicate the LCPA or similar low-cost microbial tests could be useful in rapid water safety estimation, including via crowdsourcing.


Assuntos
Água Potável/microbiologia , Água Potável/normas , Monitoramento Ambiental/métodos , Técnicas Microbiológicas/métodos , Microbiologia da Água , Abastecimento de Água/normas , Contagem de Colônia Microbiana , Monitoramento Ambiental/economia , Monitoramento Ambiental/normas , Escherichia coli/crescimento & desenvolvimento , Humanos , Índia , Estudos Longitudinais , Técnicas Microbiológicas/economia , Técnicas Microbiológicas/normas
7.
Int J Food Microbiol ; 282: 1-8, 2018 Oct 03.
Artigo em Inglês | MEDLINE | ID: mdl-29885972

RESUMO

Building mathematical models in predictive microbiology is a data driven science. As such, the experimental data (and its uncertainty) has an influence on the final predictions and even on the calculation of the model prediction uncertainty. Therefore, the current research studies the influence of both the parameter estimation and uncertainty propagation method on the calculation of the model prediction uncertainty. The study is intended as well as a tutorial to uncertainty propagation techniques for researchers in (predictive) microbiology. To this end, an in silico case study was applied in which the effect of temperature on the microbial growth rate was modelled and used to make simulations for a temperature profile that is characterised by variability. The comparison of the parameter estimation methods demonstrated that the one-step method yields more accurate and precise calculations of the model prediction uncertainty than the two-step method. Four uncertainty propagation methods were assessed. The current work assesses the applicability of these techniques by considering the effect of experimental uncertainty and model input uncertainty. The linear approximation was demonstrated not always to provide reliable results. The Monte Carlo method was computationally very intensive, compared to its competitors. Polynomial chaos expansion was computationally efficient and accurate but is relatively complex to implement. Finally, the sigma point method was preferred as it is (i) computationally efficient, (ii) robust with respect to experimental uncertainty and (iii) easily implemented.


Assuntos
Bactérias/crescimento & desenvolvimento , Técnicas Microbiológicas/normas , Algoritmos , Bactérias/química , Simulação por Computador , Modelos Teóricos , Método de Monte Carlo
8.
J AOAC Int ; 101(4): 1205-1211, 2018 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-29566783

RESUMO

Recently, a novel and effective statistical tool called the uncertainty profile has been developed with the purpose of graphically assessing the validity and estimating the measurement uncertainty of analytical procedures. One way to construct the uncertainty profile is to compute the ß-content, γ-confidence tolerance interval. In this study, we propose a tolerance interval based on the combination of the generalized pivotal quantity procedure and Monte-Carlo simulation. The uncertainty profile has been applied successfully in several fields. However, in order to further confirm its universality, this newer approach has been applied to assess the performance of an alternative procedure versus a reference procedure for counting of Escherichia coli bacteria in drinking water. Hence, the aims of this research were to expose how the uncertainty profile can be powerfully applied pursuant to ISO 16140 standards in the frame of interlaboratory study and how to easily make a decision concerning the validity of the procedure. The analysis of the results shows that after the introduction of a correction factor, the alternative procedure is deemed valid over the studied range because the uncertainty limits lie within the acceptability limits set at ±-0.3 log unit/100 ml for a ß = 66.7% and γ = 90%.


Assuntos
Técnicas Microbiológicas/estatística & dados numéricos , Técnicas Microbiológicas/normas , Método de Monte Carlo , Algoritmos , Água Potável/microbiologia , Escherichia coli , Laboratórios , Limite de Detecção , Incerteza , Microbiologia da Água/normas
9.
J Epidemiol Glob Health ; 8(3-4): 231-235, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30864769

RESUMO

OBJECTIVES: This study aimed to understand the epidemiology of meningitis cases admitted to hospitals in Oman and to identify any changing microbial patterns from the introduction of the new vaccines. METHODS: A retrospective analysis of all cases of meningitis reported through a national surveillance system. Meningitis is a notifiable disease. RESULTS: Of a total of 581 cases of meningitis from the period between January 1, 2005 and December 31, 2013, 15% (88) were confirmed to be bacterial in origin and 7.2% (42/581) viral. In 50.9% (296) of patients with suspected pyogenic meningitis, no specific bacterial pathogen were identified, and in 26% of cases (151) a cerebrospinal fluid study could not be undertaken. Among 88 cases with confirmed bacterial pathogens the organisms identified were Streptococcus pneumoniae (65.9%), Neisseria meningitides (18.2%), Haemophilus influenzae (6.8%), and other organisms (9.1%). The peak incidence was in children <2 years of age (39.4%). It showed notable decline in H. influenzae cases as well as pneumococcal meningitis cases, possibly indicative of the successful immunization program. CONCLUSION: A drop in H. Influenzae and pneumococcal meningitis cases was possibly the effect of the introduction of vaccines. It shows the need for improving diagnostic accuracy, laboratory capacities, and quality of surveillance reporting.


Assuntos
Bactérias , Meningites Bacterianas , Técnicas Microbiológicas , Bactérias/classificação , Bactérias/isolamento & purificação , Criança , Confiabilidade dos Dados , Monitoramento Epidemiológico , Feminino , Humanos , Incidência , Lactente , Masculino , Meningites Bacterianas/diagnóstico , Meningites Bacterianas/epidemiologia , Meningites Bacterianas/microbiologia , Técnicas Microbiológicas/métodos , Técnicas Microbiológicas/normas , Técnicas Microbiológicas/estatística & dados numéricos , Omã/epidemiologia , Melhoria de Qualidade/organização & administração , Estudos Retrospectivos
10.
J Clin Microbiol ; 56(1)2018 01.
Artigo em Inglês | MEDLINE | ID: mdl-29118166

RESUMO

The Wisconsin State Laboratory of Hygiene challenged Wisconsin laboratories to examine their biosafety practices and improve their culture of biosafety. One hundred three clinical and public health laboratories completed a questionnaire-based, microbiology-focused biosafety risk assessment. Greater than 96% of the respondents performed activities related to specimen processing, direct microscopic examination, and rapid nonmolecular testing, while approximately 60% performed culture interpretation. Although they are important to the assessment of risk, data specific to patient occupation, symptoms, and travel history were often unavailable to the laboratory and, therefore, less contributory to a microbiology-focused biosafety risk assessment than information on the specimen source and test requisition. Over 88% of the respondents complied with more than three-quarters of the mitigation control measures listed in the survey. Facility assessment revealed that subsets of laboratories that claim biosafety level 1, 2, or 3 status did not possess all of the biosafety elements considered minimally standard for their respective classifications. Many laboratories reported being able to quickly correct the minor deficiencies identified. Task assessment identified deficiencies that trended higher within the general (not microbiology-specific) laboratory for core activities, such as packaging and shipping, direct microscopic examination, and culture modalities solely involving screens for organism growth. For traditional microbiology departments, opportunities for improvement in the cultivation and management of highly infectious agents, such as acid-fast bacilli and systemic fungi, were revealed. These results derived from a survey of a large cohort of small- and large-scale laboratories suggest the necessity for continued microbiology-based understanding of biosafety practices, vigilance toward biosafety, and enforcement of biosafety practices throughout the laboratory setting.


Assuntos
Contenção de Riscos Biológicos/estatística & dados numéricos , Laboratórios/estatística & dados numéricos , Técnicas Microbiológicas/estatística & dados numéricos , Medição de Risco/estatística & dados numéricos , Manejo de Espécimes/estatística & dados numéricos , Contenção de Riscos Biológicos/normas , Fidelidade a Diretrizes/estatística & dados numéricos , Pesquisas sobre Atenção à Saúde , Humanos , Laboratórios/normas , Técnicas Microbiológicas/normas , Medição de Risco/normas , Manejo de Espécimes/normas , Wisconsin
11.
J Clin Microbiol ; 56(1)2018 01.
Artigo em Inglês | MEDLINE | ID: mdl-29093106

RESUMO

Conventional methods for the identification of gastrointestinal pathogens are time-consuming and expensive and have limited sensitivity. The aim of this study was to determine the clinical impact of a comprehensive molecular test, the BioFire FilmArray gastrointestinal (GI) panel, which tests for many of the most common agents of infectious diarrhea in approximately 1 h. Patients with stool cultures submitted were tested on the GI panel (n = 241) and were compared with control patients (n = 594) from the year prior. The most common organisms detected by the GI panel were enteropathogenic Escherichia coli (EPEC, n = 21), norovirus (n = 21), rotavirus (n = 15), sapovirus (n = 9), and Salmonella (n = 8). Patients tested on the GI panel had an average of 0.58 other infectious stool tests compared with 3.02 in the control group (P = 0.0001). The numbers of days on antibiotic(s) per patient were 1.73 in the cases and 2.12 in the controls (P = 0.06). Patients with the GI panel had 0.18 abdomen and/or pelvic imaging studies per patient compared with 0.39 (P = 0.0002) in the controls. The average length of time from stool culture collection to discharge was 3.4 days in the GI panel group versus 3.9 days in the controls (P = 0.04). The overall health care cost could have decreased by $293.61 per patient tested. The GI panel improved patient care by rapidly identifying a broad range of pathogens which may not have otherwise been detected, reducing the need for other diagnostic tests, reducing unnecessary use of antibiotics, and leading to a reduction in hospital length of stay.


Assuntos
Testes Diagnósticos de Rotina/economia , Gerenciamento Clínico , Gastroenterite/diagnóstico , Trato Gastrointestinal , Custos de Cuidados de Saúde/estatística & dados numéricos , Técnicas Microbiológicas/métodos , Reação em Cadeia da Polimerase , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Bactérias/genética , Bactérias/isolamento & purificação , Criança , Pré-Escolar , Diarreia/diagnóstico , Fezes/microbiologia , Fezes/virologia , Feminino , Florida , Gastroenterite/microbiologia , Gastroenterite/virologia , Trato Gastrointestinal/microbiologia , Trato Gastrointestinal/virologia , Humanos , Lactente , Recém-Nascido , Masculino , Técnicas Microbiológicas/economia , Técnicas Microbiológicas/normas , Pessoa de Meia-Idade , Reação em Cadeia da Polimerase/economia , Reação em Cadeia da Polimerase/normas , Centros de Atenção Terciária , Fatores de Tempo , Vírus/genética , Vírus/isolamento & purificação , Adulto Jovem
12.
PDA J Pharm Sci Technol ; 71(3): 234-244, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28089966

RESUMO

In this case study, the principles of quality risk management were applied to review sampling points and monitoring frequencies in the hormonal tableting unit of a formulation development pilot plant. In the cleanroom area, premises of different functions are located. Therefore a general method was established for risk evaluation based on the Hazard Analysis and Critical Control Points (HACCP) method to evaluate these premises (i.e., production area itself and ancillary clean areas) from the point of view of microbial load and state in order to observe whether the existing monitoring program met the emerged advanced monitoring practice.LAY ABSTRACT: In pharmaceutical production, cleanrooms are needed for the manufacturing of final dosage forms of drugs-intended for human or veterinary use-in order to protect the patient's weakened body from further infections. Cleanrooms are premises with a controlled level of contamination that is specified by the number of particles per cubic meter at a specified particle size or number of microorganisms (i.e. microbial count) per surface area. To ensure a low microbial count over time, microorganisms are detected and counted by environmental monitoring methods regularly. It is reasonable to find the easily infected places by risk analysis to make sure the obtained results really represent the state of the whole room. This paper presents a risk analysis method for the optimization of environmental monitoring and verification of the suitability of the method.


Assuntos
Contaminação de Medicamentos/prevenção & controle , Ambiente Controlado , Monitoramento Ambiental/métodos , Arquitetura de Instituições de Saúde , Técnicas Microbiológicas , Preparações Farmacêuticas/análise , Controle de Qualidade , Tecnologia Farmacêutica/métodos , Descontaminação , Monitoramento Ambiental/normas , Contaminação de Equipamentos/prevenção & controle , Umidade , Técnicas Microbiológicas/normas , Medição de Risco , Fatores de Risco , Gestão de Riscos , Tecnologia Farmacêutica/normas , Temperatura , Fatores de Tempo
13.
Nat Microbiol ; 1: 15015, 2016 Jan 11.
Artigo em Inglês | MEDLINE | ID: mdl-27571759

RESUMO

Genome-enabled technologies have supported a dramatic increase in our ability to study microbial communities in environments and hosts. Taking stock of previously funded microbiome research can help to identify common themes, under-represented areas and research priorities to consider moving forward. To assess the status of US microbiome research, a team of government scientists conducted an analysis of federally funded microbiome research. Microbiomes were defined as host-, ecosystem- or habitat-associated communities of microorganisms, and microbiome research was defined as those studies that emphasize community-level analyses using 'omics technologies. Single pathogen, single strain and culture-based studies were not included, except symbiosis studies that served as models for more complex communities. Fourteen governmental organizations participated in the data call. The analysis examined three broad research themes, eight environments and eight microbial categories. Human microbiome research was larger than any other environment studied, and the basic biology research theme accounted for half of the total research activities. Computational biology and bioinformatics, reference databases and biorepositories, standardized protocols and high-throughput tools were commonly identified needs. Longitudinal and functional studies and interdisciplinary research were also identified as needs. This study has implications for the funding of future microbiome research, not only in the United States but beyond.


Assuntos
Pesquisa Biomédica/tendências , Biota , Microbiologia/tendências , Pesquisa Biomédica/métodos , Financiamento de Capital , Biologia Computacional/métodos , Humanos , Metagenômica/métodos , Técnicas Microbiológicas/normas , Estados Unidos
14.
Arch Pathol Lab Med ; 139(2): 194-8, 2015 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-24758733

RESUMO

CONTEXT: Use of reference laboratories for selected laboratory testing (send-out tests) represents a significant source of laboratory costs. As the use of more complex molecular analyses becomes common in the United States, strategies to reduce costs in the clinical laboratory must evolve in order to provide high-value, cost-effective medicine. OBJECTIVE: To report a strategy that employs clinical pathology house staff and key hospital clinicians in the effective use of microbiologic send-out testing. DESIGN: The George Washington University Hospital is a 370-bed academic hospital in Washington, DC. In 2012 all requisitions for microbiologic send-out tests were screened by the clinical pathology house staff prior to final dispensation. Tests with questionable utility were brought to the attention of ordering clinicians through the use of interdisciplinary rounds and direct face-to-face consultation. RESULTS: Screening resulted in a cancellation rate of 38% of send-out tests, with proportional cost savings. Nucleic acid tests represented most of the tests screened and the largest percentage of cost saved through screening. Following consultation, requested send-out tests were most often canceled because of a lack of clinical indication. CONCLUSIONS: Direct face-to-face consultation with ordering physicians is an effective, interdisciplinary approach to managing the use of send-out testing in the microbiology laboratory.


Assuntos
Laboratórios Hospitalares/economia , Técnicas Microbiológicas/economia , Serviços Terceirizados/economia , Serviço Hospitalar de Patologia/economia , Serviços de Laboratório Clínico/economia , Análise Custo-Benefício , Tomada de Decisões Gerenciais , Humanos , Laboratórios Hospitalares/estatística & dados numéricos , Técnicas Microbiológicas/normas , Técnicas Microbiológicas/estatística & dados numéricos , Serviços Terceirizados/estatística & dados numéricos , Serviço Hospitalar de Patologia/estatística & dados numéricos , Médicos , Encaminhamento e Consulta , Estados Unidos , Revisão da Utilização de Recursos de Saúde
16.
J Microbiol Methods ; 97: 68-73, 2014 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-24280193

RESUMO

Extraction of DNA from soil samples using standard methods often results in low yield and poor quality making them unsuitable for community analysis through polymerase chain reaction (PCR) due to the formation of chimeric products with smaller template DNAs and the presence of humic substances. The present study focused on the assessment of five different methods for metagenomic DNA isolation from soil samples on the basis of processing time, purity, DNA yield, suitability for PCR, restriction digestion and mDNA library construction. A simple and rapid alkali lysis based on indirect DNA extraction from soil was developed which could remove 90% of humic substances without shearing the DNA and permits the rapid and efficient isolation of high quality DNA without the requirement of hexadecyltrimethylammonium bromide and phenol cleanup. The size of DNA fragment in the crude extracts was >23 kb and yield 0.5-5 µg/g of soil. mDNA purification using Sephadex G-50 resin yielded high concentration of DNA from soil samples, which has been successfully used for 16S rDNA based amplification of a 1500 bp DNA fragment with 27F and 1492R universal primers followed by restriction digestion and mDNA library construction.


Assuntos
DNA Bacteriano/isolamento & purificação , Biblioteca Gênica , Técnicas Microbiológicas/métodos , Técnicas Microbiológicas/normas , RNA Ribossômico 16S/genética , Microbiologia do Solo , DNA Bacteriano/análise , Substâncias Húmicas/análise , Solo/química
17.
Clin Infect Dis ; 57 Suppl 3: S139-70, 2013 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-24200831

RESUMO

In this IDSA policy paper, we review the current diagnostic landscape, including unmet needs and emerging technologies, and assess the challenges to the development and clinical integration of improved tests. To fulfill the promise of emerging diagnostics, IDSA presents recommendations that address a host of identified barriers. Achieving these goals will require the engagement and coordination of a number of stakeholders, including Congress, funding and regulatory bodies, public health agencies, the diagnostics industry, healthcare systems, professional societies, and individual clinicians.


Assuntos
Doenças Transmissíveis/diagnóstico , Técnicas Microbiológicas/métodos , Técnicas Microbiológicas/normas , Técnicas de Diagnóstico Molecular/métodos , Técnicas de Diagnóstico Molecular/normas , Política de Saúde , Necessidades e Demandas de Serviços de Saúde , Humanos , Sistemas Automatizados de Assistência Junto ao Leito , Saúde Pública
19.
Rev Panam Salud Publica ; 33(1): 73-8, 2013 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-23440160

RESUMO

This report describes a survey of microbiology laboratories (n = 467) serving Brazilian hospitals with ≥10 intensive care beds and/or involved in the government health care adverse event reporting system. Coordinators were interviewed and laboratories classified as follows: Level 0 (no minimal functioning conditions-85.4% of laboratories); Level 1 (minimal functioning conditions but inadequate execution of basic routine-6.7%); Level 2 (minimal functioning conditions and adequate execution of basic routine but no adequate procedures for quality control-5.8%); Level 3 (minimal functioning conditions, adequate execution of basic routine, and adequate procedures for quality control, but no direct communication with the infection control department-0.9%); Level 4 (minimal functioning conditions, adequate execution of basic routine, adequate procedures for quality control, and direct communication with infection control, but no available advanced resources-none); and Level 5 (minimal functioning conditions, adequate execution of basic routine, adequate procedures for quality control, direct communication with infection control, and available advanced resources-0.9%). Twelve laboratories did not perform Ziehl-Neelsen staining; 271 did not have safety cabinets; and >30% without safety cabinets had automated systems. Low quality was associated with serving hospitals not participating in government adverse-event program; private hospitals; nonteaching hospitals; and those outside state capitals. Results may reflect what occurs in many other countries where defining priorities is important due to limited resources.


Assuntos
Hospitais , Laboratórios/normas , Técnicas Microbiológicas/normas , Alocação de Recursos/normas , Brasil , Coleta de Dados , Humanos , Controle de Infecções , Controle de Qualidade
20.
Rev. panam. salud pública ; 33(1): 73-78, ene. 2013. tab
Artigo em Inglês | LILACS | ID: lil-666286

RESUMO

This report describes a survey of microbiology laboratories (n = 467) serving Brazilian hospitals with >10 intensive care beds and/or involved in the government health care adverse event reporting system. Coordinators were interviewed and laboratories classified as follows: Level 0 (no minimal functioning conditions-85.4% of laboratories); Level 1 (minimal functioning conditions but inadequate execution of basic routine-6.7%); Level 2 (minimal functioning conditions and adequate execution of basic routine but no adequate procedures for quality control-5.8%); Level 3 (minimal functioning conditions, adequate execution of basic routine, and adequate procedures for quality control, but no direct communication with the infection control department-0.9%); Level 4 (minimal functioning conditions, adequate execution of basic routine, adequate procedures for quality control, and direct communication with infection control, but no available advanced resources-none); and Level 5 (minimal functioning conditions, adequate execution of basic routine, adequate procedures for quality control, direct communication with infection control, and available advanced resources-0.9%). Twelve laboratories did not perform Ziehl-Neelsen staining; 271 did not have safety cabinets; and >30% without safety cabinets had automated systems. Low quality was associated with serving hospitals not participating in government adverse-event program; private hospitals; nonteaching hospitals; and those outside state capitals. Results may reflect what occurs in many other countries where defining priorities is important due to limited resources.


Este artículo describe una encuesta realizada en Brasil en laboratorios de microbiología (n = 467) que prestaban servicio a hospitales que contaban al menos con 10 camas de cuidados intensivos. Se entrevistó a los coordinadores y los laboratorios se clasificaron de la siguiente manera: nivel 0 (sin condiciones de funcionamiento mínimas: 85,4% de los laboratorios), nivel 1 (condiciones de funcionamiento mínimas pero ejecución inadecuada del trabajo habitual básico: 6,7%), nivel 2 (condiciones de funcionamiento mínimas y ejecución adecuada del trabajo habitual básico, pero sin procedimientos de control de calidad apropiados: 5,8%), nivel 3 (condiciones de funcionamiento mínimas, ejecución adecuada del trabajo habitual básico y procedimientos de control de calidad apropiados, pero sin comunicación directa con el departamento de control de infecciones: 0,9%), nivel 4 (condiciones de funcionamiento mínimas, ejecución adecuada del trabajo habitual básico, procedimientos de control de calidad apropiados y comunicación directa con el departamento de control de infecciones, pero sin recursos avanzados disponibles: ningún laboratorio) y nivel 5 (condiciones de funcionamiento mínimas, ejecución adecuada del trabajo habitual básico, procedimientos de control de calidad apropiados, comunicación directa con el departamento de control de infecciones y recursos avanzados disponibles: 0,9%). Doce laboratorios no realizaban la tinción de Ziehl-Neelsen, 271 no contaban con cámaras de seguridad biológica, y más de 30% de los laboratorios que carecían de cámaras de seguridad biológica tenían sistemas automatizados. La escasa calidad se asoció a la falta de participación en el programa gubernamental de notificación de acontecimientos adversos, a los hospitales privados, a los hospitales no docentes y a la ubicación de los hospitales fuera de las capitales de los estados. Los resultados pueden reflejar lo que ocurre en muchos otros países con recursos limitados, donde es importante definir las prioridades.


Assuntos
Humanos , Hospitais , Laboratórios/normas , Técnicas Microbiológicas/normas , Alocação de Recursos/normas , Brasil , Coleta de Dados , Controle de Infecções , Controle de Qualidade
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