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1.
JMIR Public Health Surveill ; 10: e50407, 2024 Mar 20.
Artigo em Inglês | MEDLINE | ID: mdl-38506899

RESUMO

BACKGROUND: The Ministry of Health in Côte d'Ivoire and the International Training and Education Center for Health at the University of Washington, funded by the United States President's Emergency Plan for AIDS Relief, have been collaborating to develop and implement the Open-Source Enterprise-Level Laboratory Information System (OpenELIS). The system is designed to improve HIV-related laboratory data management and strengthen quality management and capacity at clinical laboratories across the nation. OBJECTIVE: This evaluation aimed to quantify the effects of implementing OpenELIS on data quality for laboratory tests related to HIV care and treatment. METHODS: This evaluation used a quasi-experimental design to perform an interrupted time-series analysis to estimate the changes in the level and slope of 3 data quality indicators (timeliness, completeness, and validity) after OpenELIS implementation. We collected paper and electronic records on clusters of differentiation 4 (CD4) testing for 48 weeks before OpenELIS adoption until 72 weeks after. Data collection took place at 21 laboratories in 13 health regions that started using OpenELIS between 2014 and 2020. We analyzed the data at the laboratory level. We estimated odds ratios (ORs) by comparing the observed outcomes with modeled counterfactual ones when the laboratories did not adopt OpenELIS. RESULTS: There was an immediate 5-fold increase in timeliness (OR 5.27, 95% CI 4.33-6.41; P<.001) and an immediate 3.6-fold increase in completeness (OR 3.59, 95% CI 2.40-5.37; P<.001). These immediate improvements were observed starting after OpenELIS installation and then maintained until 72 weeks after OpenELIS adoption. The weekly improvement in the postimplementation trend of completeness was significant (OR 1.03, 95% CI 1.02-1.05; P<.001). The improvement in validity was not statistically significant (OR 1.34, 95% CI 0.69-2.60; P=.38), but validity did not fall below pre-OpenELIS levels. CONCLUSIONS: These results demonstrate the value of electronic laboratory information systems in improving laboratory data quality and supporting evidence-based decision-making in health care. These findings highlight the importance of OpenELIS in Côte d'Ivoire and the potential for adoption in other low- and middle-income countries with similar health systems.


Assuntos
Sistemas de Informação em Laboratório Clínico , Infecções por HIV , Humanos , Laboratórios Clínicos , Laboratórios , Côte d'Ivoire , Eletrônica
2.
Clin Lab Med ; 44(1): 95-107, 2024 03.
Artigo em Inglês | MEDLINE | ID: mdl-38280801

RESUMO

Molecular microbiology assays have a higher cost of testing compared to traditional methods and need to be utilized appropriately. Results from these assays may also require interpretation and appropriate follow-up. Electronic tools available in the electronic health record and laboratory information system can be deployed both preanalytically and postanalytically to influence ordering behaviors and positively impact diagnostic stewardship. Next generation technologies, such as machine learning and artificial intelligence, have the potential to expand upon the capabilities currently available and warrant additional study and development but also require regulation around their use in health care.


Assuntos
Sistemas de Informação em Laboratório Clínico , Registros Eletrônicos de Saúde , Inteligência Artificial
3.
Stud Health Technol Inform ; 310: 875-880, 2024 Jan 25.
Artigo em Inglês | MEDLINE | ID: mdl-38269934

RESUMO

As Rwanda approaches the UNAIDS Fast Track goals which recommend that 95% of HIV-infected individuals know their status, of whom 95% should receive treatment and 95% of those on treatment achieve viral suppression, the country currently relies on an inefficient paper, and disjointed electronic, systems for case-based surveillance (CBS). Rwanda has established an ecosystem of interoperable systems based on open standards to support HIV CBS. Data were successfully exchanged between an EMR, a client registry, laboratory information system and DHIS-2 Tracker, and subsequently, a complete analytic dataset was ingested into MS-Power Business Intelligence (MS-PowerBI) for analytics and visualization of the CBS data. Existing challenges included inadequate workforce capacity to support mapping of data elements to HL7 FHIR resources. Interoperability optimization to support CBS is work in progress and rigorous evaluations on the effect on health information exchange on monitoring patient outcomes are needed.


Assuntos
Sistemas de Informação em Laboratório Clínico , Infecções por HIV , Troca de Informação em Saúde , Humanos , Infecções por HIV/terapia , Ruanda
4.
Trop Doct ; 54(1): 7-8, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37844878

RESUMO

Standard urine culture is the gold standard for diagnosing urinary tract infections (UTIs) but fails to differentiate true UTI from asymptomatic bacteriuria, which is important to prevent the overuse of antibiotics. Correlation with the presence or absence of pyuria can be helpful in giving a hint of the true situation. With the help of Laboratory Information System (LIS), patients' urinalysis reports can be conveniently accessed and compared simultaneously with appropriate reports. In our study, a quality improvement initiative was planned for appropriate reporting of urine culture and antimicrobial susceptibility testing using information obtained through LIS.


Assuntos
Bacteriúria , Sistemas de Informação em Laboratório Clínico , Infecções Urinárias , Humanos , Melhoria de Qualidade , Infecções Urinárias/diagnóstico , Urinálise , Bacteriúria/diagnóstico
5.
Clin Chem Lab Med ; 62(2): 341-352, 2024 Jan 26.
Artigo em Inglês | MEDLINE | ID: mdl-37673465

RESUMO

OBJECTIVES: Currently, most medical laboratories do not have a dedicated software for managing report recalls, and relying on traditional manual methods or laboratory information system (LIS) to record recall data is no longer sufficient to meet the quality management requirements in the large regional laboratory center. The purpose of this article was to describe the research process and preliminary evaluation results of integrating the Medical Laboratory Electronic Record System (electronic record system) laboratory report recall function into the iLab intelligent management system for quality indicators (iLab system), and to introduce the workflow and methods of laboratory report recall management in our laboratory. METHODS: This study employed cluster analysis to extract commonly used recall reasons from laboratory report recall records in the electronic record system. The identified recall reasons were validated for their applicability through a survey questionnaire and then incorporated into the LIS for selecting recall reasons during report recall. The statistical functionality of the iLab system was utilized to investigate the proportion of reports using the selected recall reasons among the total number of reports, and to perform visual analysis of the recall data. Additionally, we employed P-Chart to establish quality targets and developed a "continuous improvement process" electronic flow form. RESULTS: The reasons for the recall of laboratory reports recorded in the electronic recording system were analyzed. After considering the opinions of medical laboratory personnel, a total of 12 recall reasons were identified, covering 73.05 % (1854/2538) of the recalled laboratory reports. After removing data of mass spectra lab with significant anomalies, the coverage rate increased to 82.66 % (1849/2237). The iLab system can generate six types of statistical graphs based on user needs, including statistical time, specialty labs (or divisions), test items, reviewers, reasons for report recalls, and distribution of the recall frequency of 0-24 h reports. The control upper limit of the recall rate of P-Chart based on laboratory reports can provide quality targets suitable for each professional group at the current stage. Setting the five stages of continuous process improvement reasonably and rigorously can effectively achieve the goal of quality enhancement. CONCLUSIONS: The enhanced iLab system enhances the intelligence and sustainable improvement capability of the recall management of laboratory reports, thus improving the efficiency of the recall management process and reducing the workload of laboratory personnel.


Assuntos
Sistemas de Informação em Laboratório Clínico , Registros Eletrônicos de Saúde , Humanos , Software , Laboratórios , Unidades Hospitalares
6.
Clin Lab ; 69(6)2023 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-37307115

RESUMO

BACKGROUND: The rapid detection of C-reactive protein (CRP) in whole blood can provide a basis for reducing the use of antibiotics, especially for infants in whom blood collection is difficult. Whether the performance of PA990pro for CRP detection can meet clinical needs has not been studied. METHODS: Between May and June 2022, 230 blood samples were collected to explore the analytical performance of the PA990pro for CRP detection. The blank check, carryover, repeatability, intermediate precision, linearity, sample stability, the influence of hematocrit (HCT)/triglyceride/bilirubin, and the trueness of the PA990pro were evaluated. Whole blood CRP test results analyzed using the PA990pro were compared to plasma CRP test results from a Hitachi 7180 biochemical analyzer, using the same samples. RESULTS: The blank check (≤ 0.3 mg/L), carryovers (≤ 0.05%), repeatability (≤ 7.23%), and intermediate precision (≤ 7.36%) can meet clinical needs. The linear correlation coefficients of different ranges of CRP were good (r >0.975), and the slopes were all within 0.950 - 1.050. The stability of samples was good within 72 hours whether stored at 18 - 25℃ or 2 - 8℃ (CV < 10%). With interference from triglycerides at ≤ 7 mmol/L, the deviation of CRP was < 10% and with bilirubin at ≤ 216 µmol/L, the deviation of CRP was < 10%. PA990pro has no HCT quantification function; abnormal HCT will significantly interfere with whole blood CRP results (the relative deviation in the basic experiment was up to 73.71%). We suggest that the HCT results of the patient during the same period are provided through the laboratory information system (LIS) so that a CRP correction formula (CRPcorrected = CRPmeasured*(1 - 40%)/(1 - HCTmeasured)) can be used on the LIS. After using the formula to perform the HCT correction, the results of PA990pro were well correlated with the 7180 analyzer plasma CRP detection (r > 0.975). PA990pro could pass the external quality assessment of the National Center for Clinical Laboratories. CONCLUSIONS: The CRP detection performance of PA990pro can meet clinical needs, but it is suggested that HCT should be corrected by the formula set in LIS. It is a simple, rapid, and cost-free approach that can be used to obtain a modified whole blood CRP test result that meets clinical needs.


Assuntos
Proteína C-Reativa , Sistemas de Informação em Laboratório Clínico , Lactente , Humanos , Hematócrito , Antibacterianos , Bilirrubina , Triglicerídeos
7.
Stud Health Technol Inform ; 305: 491-494, 2023 Jun 29.
Artigo em Inglês | MEDLINE | ID: mdl-37387074

RESUMO

This paper discusses the development and implementation of an API to integrate external laboratory information systems with a national e-health operator using LOINC codes as a standard measurement vocabulary. The integration provides many benefits, including reduced risk of medical errors, unnecessary tests, and administrative burden on healthcare providers. Security measures were implemented to prevent unauthorized access to sensitive patient information. The "Armed eHealth" mobile application was developed to allow patients to access their lab test results directly on their mobile devices. The implementation of the universal coding system has improved communication, reduced duplications, and improved the quality of care for patients in Armenia. Overall, the integration of the universal coding system for lab tests has had a positive impact on the healthcare system in Armenia.


Assuntos
Sistemas de Informação em Laboratório Clínico , Registros Eletrônicos de Saúde , Humanos , Comunicação , Computadores de Mão , Pessoal de Saúde
8.
Public Health Rep ; 138(4): 602-609, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37125740

RESUMO

OBJECTIVES: Public health laboratories (PHLs) are essential components of US Public Health Service operations. The health information technology that supports PHLs is central to effective and efficient laboratory operations and overall public health response to infectious disease management. This analysis presents key information on how the Nebraska Public Health Laboratory (NPHL) information technology system evolved to meet the demands of the COVID-19 pandemic. MATERIALS AND METHODS: COVID-19 presented numerous, unforeseen information technology system challenges. The most notable challenges requiring changes to NPHL software systems and capability were improving efficiency of the laboratory operation due to high-volume testing, responding daily to demands for timely data for analysis by partner systems, interfacing with multiple testing (equipment) platforms, and supporting community-based specimen collection programs. RESULTS: Improvements to the NPHL information technology system enabled NPHL to perform >121 000 SARS-CoV-2 polymerase chain reaction tests from March 2020 through January 2022 at a sustainable rate of 2000 SARS-CoV-2 tests per day, with no increase in laboratory staffing. Electronic reporting of 62 000 rapid antigen tests eliminated paper reporting and extended testing services throughout the state. Collection of COVID-19 symptom data before specimen collection enabled NPHL to make data-driven decisions to perform pool testing and conserve testing kits when supplies were low. PRACTICE IMPLICATIONS: NPHL information technology applications proved essential for managing health care provider workload, prioritizing the use of scarce testing supplies, and managing Nebraska's overall pandemic response. The NPHL experience provides useful examples of a highly capable information technology system and suggests areas for additional attention in the PHL environment, including a focus on end users, collaboration with various partners, and investment in information technology.


Assuntos
COVID-19 , Sistemas de Informação em Laboratório Clínico , Humanos , COVID-19/epidemiologia , Laboratórios , SARS-CoV-2 , Nebraska/epidemiologia , Saúde Pública , Pandemias , Emergências
9.
J Forensic Sci ; 68(4): 1335-1342, 2023 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-37243363

RESUMO

The National Forensic Laboratory Information System (NFLIS) is a drug surveillance program of the US Drug Enforcement Administration that systematically collects data on drugs that are seized by law enforcement and submitted to and analyzed by the Nation's forensic laboratories (NFLIS-Drug). NFLIS-Drug data are increasingly used in predictive modeling and drug surveillance to examine drug availability patterns. Given the complexity of the data and data collection, there are some common methodological pitfalls that we highlight with the aim of helping researchers avoid these concerns. The analysis done for this Technical Note is based on a review of the scientific literature that includes 428 unique, refereed article citations in 182 distinct journals published between January 1, 2005, and April 30, 2021. Each article was analyzed according to how NFLIS-Drug data were mentioned and whether NFLIS-Drug data were included. A sample of 37 articles was studied in-depth, and data issues were summarized. Using examples from the literature, this Technical Note highlights eight broad concerns that have important implications for the proper applications, interpretations, and limitations of NFLIS-Drug data with suggestions for improving research methods and accurate reporting of forensic drug data. NFLIS-Drug data are timely and provide key information to inform drug use trends across the United States; however, our present analysis shows that NFLIS-Drug data are misunderstood and represented in the literature. In addition to highlighting these issues, DEA has created several resources to assist NFLIS data users and researchers, which are summarized in the discussion.


Assuntos
Sistemas de Informação em Laboratório Clínico , Transtornos Relacionados ao Uso de Substâncias , Estados Unidos , Humanos , Preparações Farmacêuticas , Medicina Legal , Aplicação da Lei
10.
BMC Med Inform Decis Mak ; 23(1): 61, 2023 04 06.
Artigo em Inglês | MEDLINE | ID: mdl-37024877

RESUMO

BACKGROUND: The process of initiating and completing clinical drug trials in hospital settings is highly complex, with numerous institutional, technical, and record-keeping barriers. In this study, we independently developed an integrated clinical trial management system (CTMS) designed to comprehensively optimize the process management of clinical trials. The CTMS includes system development methods, efficient integration with external business systems, terminology, and standardization protocols, as well as data security and privacy protection. METHODS: The development process proceeded through four stages, including demand analysis and problem collection, system design, system development and testing, system trial operation, and training the whole hospital to operate the system. The integrated CTMS comprises three modules: project approval and review management, clinical trial operations management, and background management modules. These are divided into seven subsystems and 59 internal processes, realizing all the functions necessary to comprehensively perform the process management of clinical trials. Efficient data integration is realized through extract-transform-load, message queue, and remote procedure call services with external systems such as the hospital information system (HIS), laboratory information system (LIS), electronic medical record (EMR), and clinical data repository (CDR). Data security is ensured by adopting corresponding policies for data storage and data access. Privacy protection complies with laws and regulations and de-identifies sensitive patient information. RESULTS: The integrated CTMS was successfully developed in September 2015 and updated to version 4.2.5 in March 2021. During this period, 1388 study projects were accepted, 43,051 electronic data stored, and 12,144 subjects recruited in the First Affiliated Hospital, Zhejiang University School of Medicine. CONCLUSION: The developed integrated CTMS realizes the data management of the entire clinical trials process, providing basic conditions for the efficient, high-quality, and standardized operation of clinical trials.


Assuntos
Sistemas de Informação em Laboratório Clínico , Sistemas de Informação Hospitalar , Humanos , Registros Eletrônicos de Saúde , Armazenamento e Recuperação da Informação
12.
Int J Med Inform ; 170: 104977, 2023 02.
Artigo em Inglês | MEDLINE | ID: mdl-36608629

RESUMO

PURPOSE: Côte d'Ivoire has a tiered public health laboratory system of 9 reference laboratories, 77 laboratories at regional and general hospitals, and 100 laboratories among 1,486 district health centers. Prior to 2009, nearly all of these laboratories used paper registers and reports to collect and report laboratory data to clinicians and national disease monitoring programs. PROJECT: Since 2009 the Ministry of Health (MOH) in Côte d'Ivoire has sought to implement a comprehensive set of activities aimed at strengthening the laboratory system. One of these activities is the sustainable development, expansion, and technical support of an open-source electronic laboratory information system (OpenELIS), with the long-term goal of Ivorian technical support and managerial sustainment of the system. This project has addressed the need for a comprehensive, customizable, low- to no-cost, open-source LIS to serve the public health systems with initial attention to HIV clients and later expansion to cover the general population. This descriptive case study presents the first published summary of original work which has been ongoing since 2009 in Côte d'Ivoire to transform the laboratory information management systems and processes nationally. IMPACT: OpenELIS is now in use at 106 laboratories across Côte d'Ivoire. This article describes the iterative planning, design, and implementation process of OpenELIS in Côte d'Ivoire, and the evolving leadership, ownership, and capacity of the Ivorian MOH in sustaining the system. This original work synthesizes lessons learned from this 13-year experience towards strengthening laboratory information systems in other low resource settings.


Assuntos
Sistemas de Informação em Laboratório Clínico , Humanos , Côte d'Ivoire/epidemiologia , Saúde Pública , Laboratórios
13.
Clin Biochem ; 113: 21-28, 2023 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-36603804

RESUMO

OBJECTIVES: Rapid and accurate laboratory tests are essential to support clinical decision-making. Despite the various efforts to control quality in the laboratory, our outpatient chemistry turnaround time (TAT) has deteriorated since 2018. Moreover, these difficulties have accelerated further due to the COVID-19 pandemic. Therefore, we aimed to improve laboratory work efficiency by identifying and eliminating the causes of reduced laboratory work efficiency. DESIGN & METHODS: We surveyed to identify tasks that reduce work efficiency. Based on our survey, a new-concept of work assistance middleware linked to laboratory information system (LIS) was developed. The middleware supports test end-time prediction, automatic real-time TAT monitoring, and urgent test requests so that medical technologists can focus on their chemistry tests. The developed middleware was used for 6 months in laboratory and outpatient clinics, and its effectiveness was evaluated. RESULTS: The median TAT for outpatient chemistry tests was reduced by 6.6 min, from 72.4 min to 65.8 min. And not only did the maximum TAT for the sample decrease from 353 min to 214 min, but the proportion of samples exceeding the TAT target (120 min) also decreased by 77%; from 2.00% in 2010 (1,905 out of 94,989 samples) to 0.46% in 2021 (453 out of 98,117 samples). 2,199 samples were urgently requested through middleware, and they were processed about 15% faster than other samples, effectively performing urgent tests. The test end-time prediction showed an error of 8.6 min in the evaluation using the MAE (Mean Absolute Error) index. CONCLUSIONS: Through this study, the quality and efficiency of the laboratory were improved, and while reducing the workload of medical staff, it contributed to enhancing patient safety and satisfaction.


Assuntos
COVID-19 , Sistemas de Informação em Laboratório Clínico , Humanos , Pacientes Ambulatoriais , Melhoria de Qualidade , Pandemias/prevenção & controle , Fatores de Tempo , COVID-19/diagnóstico , Testes de Química Clínica
14.
Comb Chem High Throughput Screen ; 26(8): 1451-1460, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36111772

RESUMO

BACKGROUND: Recently, laboratory information systems (LIS) have become necessary for every laboratory to improve the decision-making process and achieve better treatment and diagnostic results. By standardizing laboratory's tests, procedures, and workflows, the software enables laboratories to improve patient care, reduce human error, and constructively lower operating costs. Implementing LIS has a multidimensional impact on improving the delivery of laboratory services. OBJECTIVES: This paper aims to investigate how patient services can be improved by laboratory information system. METHODS: This paper is based on a review conducted by searching PubMed, Google Scholar, Saudi Digital Library and Research Gate for English language articles published from 2015 to 2021 and focused primarily on laboratory information systems. RESULTS: The literature searches yielded a total of 30 articles that were then initially screened based on the titles and abstracts. Seven articles were excluded because they did not primarily address LIMS for biosafety, automated verification of test results in the core clinical laboratory, clinical biochemistry, or the impact of health information technology on patient safety, or were not written in English. The remaining 23 articles were then screened in full text. CONCLUSION: Advanced laboratory information systems may eliminate diagnostic errors in the preanalytical, analytical, and postanalytical phases. In addition, they can incorporate genomic data at the analytical stage to generate useful reports for providers and patients.


Assuntos
Sistemas de Informação em Laboratório Clínico , Humanos
15.
J Hematop ; 16(3): 131-140, 2023 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-38175400

RESUMO

Central nervous system (CNS) involvement is a serious complication in hematologic malignancy, and early detection and management of CNS involvement in these cases significantly impact the prognosis. Currently, there is no consensus on the use of multiparametric flow cytometry (MFC) and conventional cytology (CC) testing for initial and follow-up cerebrospinal fluid (CSF) specimens to diagnose CNS involvement by hematologic malignancy. In our institution, after initial MFC and CC, two subsequent negative MFCs are required before discontinuing MFC. The aim of this study is to evaluate the outcome of this approach. CSF cytology and MFC reports were retrieved from Laboratory Information System, and data was reviewed. Between January 2020 and December 2021, 1789 CSF samples from 280 patients were submitted for CSF analysis. For those 517 CSF samples tested by both MFC and CC, 97 cases tested positive by both MFC and CC with 95% concordance. Eighteen cases were MFC + /CC - and 7 were MFC - /CC + . Thirty-six cases had initially positive MFCs followed by more than one MFC evaluation. Among those 36 cases, 22 cases (61.1%) converted to negative after the second follow-up sample, 9 cases (25%) were continuously positive for at least three samples, and 5 cases (13.9%) exhibited negative to positive conversion. Compared to negative CSF cases, positive CSFs had higher total nucleated cell count and higher total protein levels while red blood cells, glucose, and lactate dehydrogenase levels remained at comparable levels. The concordance between MFC and CC was excellent. The high incidence of positive MFCs on two or more follow-up samples and the high frequency of negative MFC to positive conversion indicate the necessity of repeated negative MFCs before discontinuing MFC. The fact that more than half of the positive cases converted to negative after the second CSF specimen and most follow-up positive cases can be detected by CC alone suggests it is adequate to use CC alone for follow-up CSF study after two consecutive negative MFCs.


Assuntos
Sistemas de Informação em Laboratório Clínico , Neoplasias Hematológicas , Humanos , Seguimentos , Neoplasias Hematológicas/complicações , Contagem de Células , Consenso
16.
Biochem Med (Zagreb) ; 32(3): 030704, 2022 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-35966256

RESUMO

Introduction: Autoverification (AV) is a postanalytical tool that uses algorithms to validate test results according to specified criteria. The Clinical and Laboratory Standard Institute (CLSI) document for AV of clinical laboratory test result (AUTO-10A) includes recommendations for laboratories needing guidance on implementation of AV algorithms. The aim was to design and validate the AV algorithm for biochemical tests. Materials and methods: Criteria were defined according to AUTO-10A. Three different approaches for algorithm were used as result limit checks, which are reference range, reference range ± total allowable error, and 2nd and 98th percentile values. To validate the algorithm, 720 cases in middleware were tested. For actual cases, 3,188,095 results and 194,520 reports in laboratory information system (LIS) were evaluated using the AV system. Cohen's kappa (κ) was calculated to determine the degree of agreement between seven independent reviewers and the AV system. Results: The AV passing rate was found between 77% and 85%. The highest rates of AV were in alanine transaminase (ALT), direct bilirubin (DBIL), and magnesium (Mg), which all had AV rates exceeding 85%. The most common reason for non-validated results was the result limit check (41%). A total of 328 reports evaluated by reviewers were compared to AV system. The statistical analysis resulted in a κ value between 0.39 and 0.63 (P < 0.001) and an agreement rate between 79% and 88%. Conclusions: Our improved model can help laboratories design, build, and validate AV systems and be used as starting point for different test groups.


Assuntos
Sistemas de Informação em Laboratório Clínico , Serviços de Laboratório Clínico , Humanos , Laboratórios , Laboratórios Clínicos , Universidades
17.
J Am Med Inform Assoc ; 29(8): 1372-1380, 2022 07 12.
Artigo em Inglês | MEDLINE | ID: mdl-35639494

RESUMO

OBJECTIVE: Assess the effectiveness of providing Logical Observation Identifiers Names and Codes (LOINC®)-to-In Vitro Diagnostic (LIVD) coding specification, required by the United States Department of Health and Human Services for SARS-CoV-2 reporting, in medical center laboratories and utilize findings to inform future United States Food and Drug Administration policy on the use of real-world evidence in regulatory decisions. MATERIALS AND METHODS: We compared gaps and similarities between diagnostic test manufacturers' recommended LOINC® codes and the LOINC® codes used in medical center laboratories for the same tests. RESULTS: Five medical centers and three test manufacturers extracted data from laboratory information systems (LIS) for prioritized tests of interest. The data submission ranged from 74 to 532 LOINC® codes per site. Three test manufacturers submitted 15 LIVD catalogs representing 26 distinct devices, 6956 tests, and 686 LOINC® codes. We identified mismatches in how medical centers use LOINC® to encode laboratory tests compared to how test manufacturers encode the same laboratory tests. Of 331 tests available in the LIVD files, 136 (41%) were represented by a mismatched LOINC® code by the medical centers (chi-square 45.0, 4 df, P < .0001). DISCUSSION: The five medical centers and three test manufacturers vary in how they organize, categorize, and store LIS catalog information. This variation impacts data quality and interoperability. CONCLUSION: The results of the study indicate that providing the LIVD mappings was not sufficient to support laboratory data interoperability. National implementation of LIVD and further efforts to promote laboratory interoperability will require a more comprehensive effort and continuing evaluation and quality control.


Assuntos
COVID-19 , Sistemas de Informação em Laboratório Clínico , Humanos , Laboratórios , Logical Observation Identifiers Names and Codes , SARS-CoV-2 , Estados Unidos
18.
Ann Clin Biochem ; 59(5): 316-323, 2022 09.
Artigo em Inglês | MEDLINE | ID: mdl-35443810

RESUMO

OBJECTIVES: High concentrations of low-density lipoprotein cholesterol (LDL-C) are a risk factor for cardiovascular disease. We validated the efficacy of the Martin method is useful in the estimation of LDL-C concentrations was validated in Japanese populations and derived a modified Martin method for easy laboratory information system applications. METHODS: We created 3 subject groups, including 2664 health check-up participants registered with the Resource Center for Health Science, 29,806 clinical patients (A) in the Gifu University Hospital, and 113,716 clinical patients (B) in the Fujita Health University Hospital. Each method to estimate serum LDL-C concentrations (Friedewald formula, Martin method and modified Martin method) was validated by correlation analysis with serum LDL-C concentrations measured using a direct method. RESULTS: The correlation coefficients with the direct method in terms of the Friedewald formula, Martin method, and modified Martin method were 0.963, 0.972 and 0.970 in the health check-up participants; 0.946, 0.962 and 0.961 in clinical patients A; and 0.961, 0.979 and 0.978 in clinical patients B, respectively. Concordance ratios with using the direct method in the Friedewald formula, Martin method and modified Martin method were 82.8%, 85.5% and 85.3% in the health check-up participants; 76.4%, 80.5% and 80.2% in clinical patients A; and 76.1%, 82.6% and 82.6% in clinical patients B, respectively. CONCLUSION: Our results show that the Martin and modified Martin methods display good performance in terms of the estimation of LDL-C concentrations among triglyceride concentrations of a wide range, and they may thus be useful for estimating LDL-C concentrations.


Assuntos
Doenças Cardiovasculares , Sistemas de Informação em Laboratório Clínico , Doenças Cardiovasculares/diagnóstico , LDL-Colesterol , Humanos , Japão , Triglicerídeos
19.
Biochem Med (Zagreb) ; 32(2): 020701, 2022 Jun 15.
Artigo em Inglês | MEDLINE | ID: mdl-35464748

RESUMO

Introduction: Vitamin D testing is excessively used in clinical practice, despite of the clinical guidelines statements against population screening for vitamin D deficiency. This study aimed to assess an annual number of performed 25-hydroxy vitamin D (25(OH)D) tests that were unsupported by the national guidelines for prevention, detection and therapy of vitamin D deficiency in adults and to calculate associated financial burden for the publicly funded healthcare. Materials and methods: A representative sample of requested 25(OH)D tests in 2018 (N = 474) was formed after selection and randomisation of data set (N = 5298) collected from the laboratory information system database of the Clinical Department for Laboratory Diagnostics, the Clinical Hospital Centre Rijeka. Records were classified in two groups depending on associated medical condition(s) according to the national guidelines. An annual cost of the total and group specific vitamin D testing was calculated on the base of a single test price reimbursed by the Croatian Healthcare Insurance Fund (CHIF). Results: Medical conditions with high-risk for vitamin D deficiency were detected in 43% (206/474) of vitamin D requests (group 1). Conditions not associated with vitamin D deficiency were detected in 57% (268/474) requests (group 2). A total cost of 25(OH)D testing for the CHIF was 58,729.50 EUR (25,523.79 EUR in the group 1 and 33,205.71 EUR in the group 2). Conclusions: More than half of all 25(OH)D tests performed in the clinical laboratory represent avoidable cost for the public healthcare. Prevention of population screening by vitamin D testing is needed.


Assuntos
Sistemas de Informação em Laboratório Clínico , Deficiência de Vitamina D , Adulto , Humanos , Centros de Atenção Terciária , Atenção Terciária à Saúde , Vitamina D , Deficiência de Vitamina D/diagnóstico , Deficiência de Vitamina D/epidemiologia
20.
Stud Health Technol Inform ; 288: 12-22, 2022 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-35102824

RESUMO

As a young pathologist, Donald A.B. Lindberg, M.D., tirelessly sought scientific solutions to clinical and research problems. Directing several clinical laboratories at the University of Missouri in Columbia, Dr. Lindberg developed the world's first computerized laboratory information system, speeding analysis and reporting. He directed his team in building computer systems to help clinicians retrieve medical knowledge, enable patients to find information about personal or family health issues, and provide expert automated assistance to physicians in reaching differential diagnoses outside their specialties. Developing superior functionalities with the limited information technologies of the time, Dr. Lindberg's pioneering work in Columbia foreshadowed his subsequent inspired leadership as Director of the United States National Library of Medicine.


Assuntos
Sistemas de Informação em Laboratório Clínico , Informática Médica , Medicina , Humanos , Liderança , Masculino , National Library of Medicine (U.S.) , Estados Unidos
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