55 research outputs found
A balanced scorecard for assessing a strategic plan in a clinical laboratory
The Balanced Scorecard (BSC) is a tool for strategic management that is used in many companies and organizations worldwide, both in the public
and private sector. With this purpose it has also been used in healthcare organizations and institutions but there are not many studies on the implementation of BSC methodology in the day-to-day clinical laboratory. This review shows the strategy for the development of a BSC, which includes theoretical perspective objectives, as well as some indicators and goals with which the monitoring and quantitative measurement of the achievements of a strategic plan in a clinical laboratory can be done. Moreover, the results of the indicators allow the prioritization of the initiatives to be implemented each year.
The methodology for the development of the proposed BSC includes the following steps: definition of theoretical objectives of each of the perspectives most used in the management of a clinical laboratory (customers, financial, internal processes and learning) taking into account the vision and the organizational model of the laboratory; creation of a strategic map of perspective objectives; definition of the relevant indicators to follow up on the objectives in a quantitative manner and establishment of the goals. Whether or not the laboratory is a reference laboratory, in which specific and infrequent analysis and health population programs are performed, is another fact to take into account. In this review a BSC for a reference clinical laboratory of the Spanish public sector is shown
Implantação de uma área de controladoria na empresa AD Iluminação Ltda Me
Orientador : Vicente Pacheco.Monografia (especialização) - Universidade Federal do Paraná, Setor de Ciências Sociais Aplicadas. Curso de Especialização em Gestão de NegóciosInclui referênciasResumo: A justificativa para a escolha deste tema embasou-se na necessidade de instalação de uma unidade de controladoria na empresa, para melhor analisar o controle dos estoques de entradas e saídas de mercadorias e aprimoramento do planejamento como ferramenta de controle, identificando o setor de vendas e selecionando produtos que geram saídas rápidas, não necessitando de espaço físico por períodos extensos, tampouco de importações desnecessárias. Esta pesquisa exploratória e descritiva tem por objetivo implantar uma unidade de controladoria para a empresa AD Iluminação e verificar se tal implantação traz benefícios e controle à empresa. A metodologia utilizada para a elaboração constitui-se de pesquisa qualitativa e exploratória, na qual se aborda temas referentes ao estudo da controladoria, tipologia descritiva relatando o perfil da controladoria, tendo como universo descritivo a própria empresa, de amostragem dedutiva através de entrevistas com os sócios e análise da documentação interna da empresa e finalizando com a coleta de dados qualitativa, visando o futuro controle da empresa. Após a analise dos dados obtidos verificou-se alguns resultados positivos, vendo do ponto de vista da análise econômicofinanceira da empresa, a qual obteve maior controle de seus estoques, de entradas e saídas de mercadorias e auxiliou a entrada das importações; outro benefício importante para a
empresa foi a aplicação de tal controle para o comando de novas metas e objetivos, visando futura ampliação dos negócios
Analytical performance assessment and improvement by means of the Failure mode and effect analysis (FMEA)
Introduction: Laboratories minimize risks through quality control but analytical errors still occur. Risk management can improve the quality of
processes and increase patient safety. This study aims to use the failure mode and effect analysis (FMEA) to assess the analytical performance and
measure the effectiveness of the risk mitigation actions implemented.
Materials and methods: The measurands to be included in the study were selected based on the measurement errors obtained by participating
in an External Quality Assessment (EQA) Scheme. These EQA results were used to perform an FMEA of the year 2017, providing a risk priority number
that was converted into a Sigma value (σFMEA). A root-cause analysis was done when σFMEA was lower than 3. Once the causes were determined,
corrective measures were implemented. An FMEA of 2018 was carried out to verify the effectiveness of the actions taken.
Results: The FMEA of 2017 showed that alkaline phosphatase (ALP) and sodium (Na) presented a σFMEA of less than 3. The FMEA of 2018 revealed
that none of the measurands presented a σFMEA below 3 and that σFMEA for ALP and Na had increased.
Conclusions: Failure mode and effect analysis is a useful tool to assess the analytical performance, solve problems and evaluate the effectiveness of
the actions taken. Moreover, the proposed methodology allows to standardize the scoring of the scales, as well as the evaluation and prioritization
of risks
Validation of Whole-Slide Imaging for Histolopathogical Diagnosis: Current State
Rapid advances in informatics and technological improvements
have led to the development of high-throughput whole-slide
imaging (WSI) scanners able to produce high-quality digital
images, which allow achieving a correct diagnosis of the
biopsies using virtual viewers. This technology is currently
prepared to be introduced in the departments of pathology for
routine diagnosis. The aim of this review is to analyze the
current evidence regarding the use of WSI in primary or routine
diagnosis in the different subspecialties of pathology. An
increasing number of studies have shown almost perfect inter-
and intraobserver agreement between the diagnoses obtained with
WSI and the classical diagnoses based on conventional light
microscopy. The only exception seems to be cytology, which still
requires some technological development. Although validation
studies are needed in some areas of pathology, growing evidence
indicates that WSI is a reliable tool for routine diagnosis.
Pathologists have a positive perception of the ergonomics of the
workstations, the low magnification of WSI and the possibility
of making annotations and measurements. WSI can be used from any
device and anywhere, thereby providing great opportunities for
teleconsultation. New technologies such as the recognition of
histopathology patterns using image analysis may facilitate
diagnosis and improve the reproducibility among pathologists in
the future
Cost-effectiveness of nehanced liver fibrosis test to assess liver fibrosis in chronic hepatitis C virus and alcoholic liver disease patients
AIM: To assess liver fibrosis (LF) in hepatitis C virus (HCV) and alcoholic liver disease (ALD), estimate health outcomes and costs of new noninvasive testing strategies. METHODS: A Markov model was developed to simulate LF progression in HCV and ALD for a cohort of 40-year-old men with abnormal levels of transaminases. Three different testing alternatives were studied: a single liver biopsy; annual Enhanced liver fibrosis (ELF ) followed by liver stiffness measurement (LSM) imaging as a confirmation test if the ELF test is positive; and annual ELF test without LSM. The analysis was performed from the perspective of a university hospital in Spain. Clinical data were obtained from published literature. Costs were sourced from administrative databases of the hospital. Deterministic and probabilistic sensitivity analyses were performed RESULTS: In HCV patients, annual sequential ELF test/LSM and annual ELF test alone prevented respectively 12.9 and 13.3 liver fibrosis-related deaths per 100 persons tested, compared to biopsy. The incremental cost-effectiveness ratios (ICERs) were respectively 13400 and 11500 per quality-adjusted life year (QALY). In ALD, fibrosis-related deaths decreased by 11.7 and 22.1 per 100 persons tested respectively with sequential ELF test/LSM and annual ELF test alone. ICERs were 280 and 190 per QALY, respectively. CONCLUSION: The use of the ELF test with or without a confirmation LSM are cost-effective options compared to a single liver biopsy for testing liver fibrosis in HCV and ALD patients in Spain
Economic Impact of a New Rapid PCR Assay for Detecting Influenza Virus in an Emergency Department and Hospitalized Patients.
Seasonal influenza causes significant morbidity and mortality and has a substantial economic impact on the healthcare system. The main objective of this study was to compare the cost per patient for a rapid commercial PCR assay (Xpert1 Flu) with an in-house realtime PCR test for detecting influenza virus. Community patients with influenza like-illness attending the Emergency Department (ED) as well as hospitalized patients in the Hospital Clínic of Barcelona were included. Costs were evaluated from the perspective of the hospital considering the use of resources directly related to influenza testing and treatment. For the purpose of this study, 366 and 691 patients were tested in 2013 and 2014, respectively. The Xpert1 Flu test reduced the mean waiting time for patients in the ED by 9.1 hours and decreased the mean isolation time of hospitalized patients by 23.7 hours. This was associated with a 103 (or about 70) per hospitalized patient. Sensitivity analyses showed that Xpert1 Flu is likely to be cost-saving in hospitals with different contexts and prices
Rapid Diagnosis of Staphylococcal Catheter-Related Bacteraemia in Direct Blood Samples by Real-Time PCR
Catheter-related bacteremia (CRB) is an important cause of
morbidity and mortality among hospitalized patients, being
staphylococci the main etiologic agents. The objective of this
study was to assess the use of a PCR-based assay for detection
of staphylococci directly from blood obtained through the
catheter to diagnose CRB caused by these microorganisms and to
perform a cost-effectiveness analysis. A total of 92 patients
with suspected CRB were included in the study. Samples were
obtained through the catheter. Paired blood cultures were
processed by standard culture methods and 4 ml blood samples
were processed by GeneXpert-MRSA assay for the detection of
methicillin-susceptible (MSSA) or methicillin-resistant (MRSA)
Staphylococcus aureus, and methicillin-resistant
coagulase-negative staphylococci (MR-CoNS). Sixteen CRB caused
by staphylococci were diagnosed among 92 suspected patients.
GeneXpert detected 14 out of 16 cases (87.5%), including 4 MSSA
and 10 MR-CoNS in approximately 1 hour after specimen receipt.
The sensitivity and specificity of GeneXpert were 87.5% (CI 95%:
60.4-97.8) and 92.1% (CI 95%: 83-96.7), respectively, compared
with standard culture methods. The sensitivity of GeneXpert for
S. aureus was 100%. Regarding a cost-effectiveness analysis, the
incremental cost of using GeneXpert was of 31.1euro per patient
while the incremental cost-effectiveness ratio of GeneXpert
compared with blood culture alones was about 180euro per life
year gained. In conclusion, GeneXpert can be used directly with
blood samples obtained through infected catheters to detect S.
aureus and MR-CoNS in approximately 1h after sampling. In
addition, it is cost-effective especially in areas with high
prevalence of staphylococcal CRB
Performance evaluation of the high sensitive troponin I assay on the Atellica IM analyser
The Fourth Universal Definition of Myocardial Infarction Global Taskforce recommends the use of high sensitive troponin (hs-Tn) assays in the diagnosis of acute myocardial infarction. We evaluated the analytical performance of the Atellica IM High-sensitivity Troponin I Assay (hs-TnI) (Siemens Healthcare Diagnostics Inc., Tarrytown, USA) and compared its performance to other hs-TnI assays (Siemens Advia Centaur, Dimension Vista, Dimension EXL, and Abbott Architect (Wiesbaden, Germany)) at one or more sites across Europe.
Precision, detection limit, linearity, method comparison, and interference studies were performed according to Clinical and Laboratory Standards Institute protocols. Values in 40 healthy individuals were compared to the manufacturer’s cut-offs. Sample turnaround time (TAT) was examined.
Imprecision repeatability CVs were 1.1–4.7% and within-lab imprecision were 1.8–7.6% (10.0–25,000 ng/L). The limit of blank (LoB), detection (LoD), and quantitation (LoQ) aligned with the manufacturer’s values of 0.5 ng/L, 1.6 ng/L, and 2.5 ng/L, respectively. Passing-Bablok regression demonstrated good correlations between Atellica IM analyser with other systems; some minor deviations were observed. All results in healthy volunteers fell below the 99th percentile URL, and greater than 50% of each sex demonstrated values above the LoD. No interference was observed for biotin (≤ 1500 µg/L), but a slight bias at 5.0 g/L haemoglobin and 50 ng/L Tn was observed. TAT from was fast (mean time = 10.9 minutes) and reproducible (6%CV).
Real-world analytical and TAT performance of the hs-TnI assay on the Atellica IM analyser make this assay fit for routine use in clinical laboratories
Unmasking the hidden tuberculosis mortality burden in a large postmortem study in Maputo Central Hospital, Mozambique
Sensitive tools are
needed to accurately establish the diagnosis of tuberculosis
(TB) at death, especially in low-income countries. The objective
of this study was to evaluate the burden of TB in a series of
patients who died in a tertiary referral hospital in sub-Saharan
Africa using an in-house real time PCR (TB-PCR) and the Xpert
MTB/RIF Ultra (Xpert Ultra) assay.Complete diagnostic autopsies
were performed in a series of 223 deaths (56.5% being
HIV-positive), including 54 children, 57 maternal deaths and 112
other adults occurring at the Maputo Central Hospital,
Mozambique. TB-PCR was performed in all lung, cerebrospinal
fluid and central nervous system samples in HIV-positive
patients. All samples positive for TB-PCR or showing
histological findings suggestive of TB were analysed with the
Xpert Ultra assay.TB was identified as the cause of death in 31
patients: 3/54 (6%) children, 5/57 (9%) maternal deaths and
23/112 (21%) other adults. The sensitivity of the main clinical
diagnosis to detect TB as the cause of death was 19.4% (95% CI:
7.5-37.5) and the specificity was 97.4% (94.0-99.1) compared to
autopsy findings. Concomitant TB (TB disease in a patient dying
of other causes) was found in 31 additional cases. Xpert Ultra
helped to identify 15 cases of concomitant TB. In 18 patients, "
- " DNA was identified by TB-PCR and Xpert Ultra in the absence
of histological TB lesions. Overall, 62 cases (27.8%) had TB
disease at death and 80 (35.9%) had TB findings.The use of
highly sensitive, easy to perform molecular tests in complete
diagnostic autopsies may contribute to identifying TB cases at
death that would have otherwise been missed. Routine use of
these tools in certain diagnostic algorithms for hospitalised
patients needs to be considered. Clinical diagnosis showed poor
sensitivity for the diagnosis of TB at death
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