Experience on how to implement a preanalytical and POCT unit in Madrid's IFEMA field hospital during this unprecedented COVID-19 emergency.

To fight the virus SARS-CoV-2 spread to Europe from China and to give support to the collapsed public health system, the Spanish Health Authorities developed a field hospital located in the facilities of Madrid exhibition centre (IFEMA) to admit and treat patients diagnosed with SARS-CoV-2 infectious disease (COVID-19). The Department of Laboratory Medicine of La Paz University Hospital in Madrid (LMD-HULP) was designated to provide laboratory services. Due to the emergency, the IFEMA field hospital had to be prepared for patient admission in less than 1 week and the laboratory professionals had to collaborate in a multidisciplinary group to assure that resources were available to start on time. The LMD-HULP participated together with the managers in the design of the tests portfolio and the integration of the healthcare information systems (IS) (hospital IS, laboratory IS and POCT management system). Laboratorians developed a strategy to quickly train clinicians and nurses on test requests, sample collection procedures and management/handling of the POCT blood gas analyser both by written materials and training videos. The IFEMA´s preanalytical unit managed 3782 requests, and more than 11,000 samples from March 27th to April 30th. Furthermore, 1151 samples were measured by blood gas analysers. In conclusion, laboratory professionals must be resilient and have to respond timely in emergencies as this pandemic. The lab's personnel selection, design and monitoring indicators to maintain and further improve the quality and value of laboratory services is crucial to support medical decision making and provide better patient care.

Routine Health Information System (RHIS) improvements for strengthened health system management.

BACKGROUND: A well-functioning routine health information system (RHIS) can provide the information needed for health system management, for governance, accountability, planning, policy making, surveillance and quality improvement, but poor information support has been identified as a major obstacle for improving health system management. OBJECTIVES: To assess the effects of interventions to improve routine health information systems in terms of RHIS performance, and also, in terms of improved health system management performance, and improved patient and population health outcomes. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE Ovid and Embase Ovid in May 2019. We searched Global Health, Ovid and PsycInfo in April 2016. In January 2020 we searched for grey literature in the Grey Literature Report and in OpenGrey, and for ongoing trials using the International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov. In October 2019 we also did a cited reference search using Web of Science, and a 'similar articles' search in PubMed. SELECTION CRITERIA: Randomised and non-randomised trials, controlled before-after studies and time-series studies comparing routine health information system interventions, with controls, in primary, hospital or community health care settings. Participants included clinical staff and management, district management and community health workers using routine information systems. DATA COLLECTION AND ANALYSIS: Two authors independently reviewed records to identify studies for inclusion, extracted data from the included studies and assessed the risk of bias. Interventions and outcomes were too varied across studies to allow for pooled risk analysis. We present a 'Summary of findings' table for each intervention comparisons broadly categorised into Technical and Organisational (or a combination), and report outcomes on data quality and service quality. We used the GRADE approach to assess the certainty of the evidence. MAIN RESULTS: We included six studies: four cluster randomised trials and two controlled before-after studies, from Africa and South America. Three studies evaluated technical interventions, one study evaluated an organisational intervention, and two studies evaluated a combination of technical and organisational interventions. Four studies reported on data quality and six studies reported on service quality. In terms of data quality, a web-based electronic TB laboratory information system probably reduces the length of time to reporting of TB test results, and probably reduces the overall rate of recording errors of TB test results, compared to a paper-based system (moderate certainty evidence). We are uncertain about the effect of the electronic laboratory information system on the recording rate of serious (misidentification) errors for TB test results compared to a paper-based system (very low certainty evidence). Misidentification errors are inaccuracies in transferring test results between an electronic register and patients' clinical charts. We are also uncertain about the effect of the intervention on service quality (timeliness of starting or changing a patient's TB treatment) (very low certainty evidence). A hand-held electronic device probably improves the length of time to report TB test results, and probably reduces the total frequency of recording errors in TB test results between the laboratory notebook and the electronic information record system, compared to a paper-based system (moderate-certainty evidence). We are, however, uncertain about the effect of the intervention on the frequency of serious (misidentification) errors in recording between the laboratory notebook and the electronic information record, compared to a paper-based system (very low certainty evidence). We are uncertain about the effect of a hospital electronic health information system on service quality (length of time outpatients spend at hospital, length of hospital stay, and hospital revenue collection), compared to a paper-based system (very low certainty evidence). High-intensity brief text messaging (SMS) may make little or no difference to data quality (in terms of completeness of documentation of pregnancy outcomes), compared to low-intensity brief text messaging (low-certainty evidence). We are uncertain about the effect of electronic drug stock notification (with either data management support or product transfer support) on service quality (in terms of transporting stock and stock levels), compared to paper-based stock notification (very low certainty evidence). We are uncertain about the effect of health information strengthening (where it is part of comprehensive service quality improvement intervention) on service quality (health worker motivation, receipt of training by health workers, health information index scores, quality of clinical observation of children and adults) (very low certainty evidence). AUTHORS' CONCLUSIONS: The review indicates mixed effects of mainly technical interventions to improve data quality, with gaps in evidence on interventions aimed at enhancing data-informed health system management. There is a gap in interventions studying information support beyond clinical management, such as for human resources, finances, drug supply and governance. We need to have a better understanding of the causal mechanisms by which information support may affect change in management decision-making, to inform robust intervention design and evaluation methods.

[The biobank of the German National Cohort as a resource for epidemiologic research]. / Die Biobank der Nationalen Kohorte als Ressource der epidemiologischen Forschung.

BACKGROUND: The linkage of high-quality biosamples with detailed data from medical examinations, questionnaires and interviews offers great opportunities for research. This is particularly true for large-scale prospective epidemiological studies with long observation periods, like the German National Cohort (GNC). AIM: The modalities of collecting, processing and storing biosamples of high quality and with a high throughput, as well as ethical aspects are described using the GNC as an example. MATERIAL AND METHODS: For the GNC, 200,000 randomly selected adults will be recruited by 18 study centres and will be followed up for 20-30 years. In addition to the extensive basic examination protocol, followed by reassessment examinations and follow-up questionnaires, the biorepository is a cornerstone of the GNC. RESULTS: The GNC biorepository will comprise more than 20 million aliquots of plasma, serum, erythrocytes, lymphocytes, urine, saliva, nasal swabs and stool. Preanalytics and aliquoting are performed locally in the study centres and are highly standardised and extensively automated. All samples are stored at - 80 and - 180 °C, respectively. A laboratory information system documents all processing steps and storage locations. Access to data and biosamples will be granted to researchers within and outside Germany after completion of the baseline recruitment (i.e. from 2018 onwards). DISCUSSION: Experience with already existing epidemiological biobanks shows impressive results, especially with regard to genetic research, as well as post-genomics (e.g. transcriptomics, metabolomics, epigenomics). Previous success stories explain the strongly increased demand for data and biosamples from the population. Thus the GNC will provide an important resource for biomedical research in the future.

Reducing communication delays and improving quality of care with a tuberculosis laboratory information system in resource poor environments: a cluster randomized controlled trial.

BACKGROUND: Lost, delayed or incorrect laboratory results are associated with delays in initiating treatment. Delays in treatment for Multi-Drug Resistant Tuberculosis (MDR-TB) can worsen patient outcomes and increase transmission. The objective of this study was to evaluate the impact of a laboratory information system in reducing delays and the time for MDR-TB patients to culture convert (stop transmitting). SETTING: 78 primary Health Centers (HCs) in Lima, Peru. Participants lived within the catchment area of participating HCs and had at least one MDR-TB risk factor. The study design was a cluster randomized controlled trial with baseline data. The intervention was the e-Chasqui web-based laboratory information system. Main outcome measures were: times to communicate a result; to start or change a patient's treatment; and for that patient to culture convert. RESULTS: 1671 patients were enrolled. Intervention HCs took significantly less time to receive drug susceptibility test (DST) (median 11 vs. 17 days, Hazard Ratio 0.67 [0.62-0.72]) and culture (5 vs. 8 days, 0.68 [0.65-0.72]) results. The time to treatment was not significantly different, but patients in intervention HCs took 16 days (20%) less time to culture convert (p = 0.047). CONCLUSIONS: The eChasqui system reduced the time to communicate results between laboratories and HCs and time to culture conversion. It is now used in over 259 HCs covering 4.1 million people. This is the first randomized controlled trial of a laboratory information system in a developing country for any disease and the only study worldwide to show clinical impact of such a system. TRIAL REGISTRATION: ClinicalTrials.gov NCT01201941.

Assessment of laboratory logistics management information system practice for HIV/AIDS and tuberculosis laboratory commodities in selected public health facilities in Addis Ababa, Ethiopia.

INTRODUCTION: Logistics management information system for health commodities remained poorly implemented in most of developing countries. To assess the status of laboratory logistics management information system for HIV/AIDS and tuberculosis laboratory commodities in public health facilities in Addis Ababa. METHODS: A cross-sectional descriptive study was conducted from September 2010-January 2011 at selected public health facilities. A stratified random sampling method was used to include a total of 43 facilities which, were investigated through quantitative methods using structured questionnaires interviews. Focus group discussion with the designated supply chain managers and key informant interviews were conducted for the qualitative method. RESULTS: There exists a well-designed logistics system for laboratory commodities with trained pharmacy personnel, distributed standard LMIS formats and established inventory control procedures. However, majority of laboratory professionals were not trained in LMIS. Majority of the facilities (60.5%) were stocked out for at least one ART monitoring and TB laboratory reagents and the highest stock out rate was for chemistry reagents. Expired ART monitoring laboratory commodities were found in 25 (73.5%) of facilities. Fifty percent (50%) of the assessed hospitals and 54% of health centers were currently using stock/bin cards for all HIV/AIDS and TB laboratory commodities in main pharmacy store, among these only 25% and 20.8% of them were updated with accurate information matching with the physical count done at the time of visit for hospitals and health centers respectively. CONCLUSION: Even though there exists a well designed laboratory LMIS, keeping quality stock/bin cards and LMIS reports were very low. Key ART monitoring laboratory commodities were stock out at many facilities at the day of visit and during the past six months. Based on findings, training of laboratory personnel's managing laboratory commodities and keeping accurate inventory control procedures were recommended.

The laboratory efficiencies initiative: partnership for building a sustainable national public health laboratory system.

Beginning in early 2011, the Centers for Disease Control and Prevention and the Association of Public Health Laboratories launched the Laboratory Efficiencies Initiative (LEI) to help public health laboratories (PHLs) and the nation's entire PHL system achieve and maintain sustainability to continue to conduct vital services in the face of unprecedented financial and other pressures. The LEI focuses on stimulating substantial gains in laboratories' operating efficiency and cost efficiency through the adoption of proven and promising management practices. In its first year, the LEI generated a strategic plan and a number of resources that PHL directors can use toward achieving LEI goals. Additionally, the first year saw the formation of a dynamic community of practitioners committed to implementing the LEI strategic plan in coordination with state and local public health executives, program officials, foundations, and other key partners.

Sistema Gerenciador de Ambiente Laboratorial: relato de experiência de uma ferramenta transformadora para a gestão laboratorial e vigilância em saúde / Laboratory Environment Management System: account of an experience with a transformational tool for laboratory management and health surveillance

Objetivo: apresentar o relato da experiência de implantação do sistema Gerenciador de Ambiente Laboratorial (GAL) como ferramenta de monitoramento e controle de exames laboratoriais, essencial à gestão e ao acompanhamento dos programas de saúde pública brasileira. Métodos: o GAL foi proposto como ferramenta de monitoramento e controle de exames laboratoriais, essencial à gestão e ao acompanhamento dos programas de saúde pública brasileira. O relato foi elaborado a partir de pesquisa documental. Resultados: o GAL tem favorecido a comunicação da informação, fornecendo subsídios para a melhoria na divulgação dos resultados dos ensaios e exames diagnósticos e planos estratégicos na área de saúde. Conclusão: após a implantação do GAL, houve uma melhora substancial na forma de gestão da informação adotada pelos laboratórios de saúde pública.

Objective: to present a report on the experience of implanting the Laboratory Environment Management (GAL) system as a tool for monitoring and controlling laboratory tests. Methods: GAL has been proposed as a tool for monitoring and controlling laboratory tests, vital to the management and monitoring of public health programs in Brazil. The report was compiled from documentary research. Results: GAL has favoured the communication of information, providing input for improving the dissemination of assay and diagnostic test results as well as strategic plans for health. Conclusion: following GAL’s implantation, there has been a substantial improvement in information management by public health laboratories.

MedCom: laboratory test ordering--fully implemented nationwide in less than 3 years.

Lab test result reporting has been fully implemented in Denmark since early 2000. Labtest ordering is much more complicated due to different handling and labeling procedures in more than 70 Danish labs. Until 2004 all orders were based on preprinted paper forms. A new electronic national lab test order solution based on national MedCom standards and codes was introduced in 2005 and it was fully implemented in all 2100 GP clinics and 1000 private specialist clinics in 3 years. It also included 42 biochemistry labs, 14 Microbiology labs and 16 histopathology and cytology labs. Implementation was organized by MedCom and planned in rough details. During the implementation period a set of planed and ad-hoc activities to reach 100 % implementation was successfully launched. Today more than 6.000.000 lab test orders (100%) are now handled electronically each year. The implementation process, the challenges: organizational and technically as well as outcome is described in the paper.

Challenges and benefits of adding laboratory data to a mortality risk adjustment method.

BACKGROUND: There is increased interest in improving the clinical acceptance and statistical performance of hospital mortality rate comparisons. This study assessed the feasibility of linking separate electronic feeds of laboratory data and claims-based information and, if successful, to identify laboratory data elements that significantly improved mortality rate predictions for All-Patient Refined Diagnosis Related Groups (APRDRGs), a risk of mortality (ROM) classification tool in regular use for public reporting purposes. METHODS: The Florida Agency for Health Care Administration recruited 15 hospitals to supply computerized administrative and laboratory information that could be linked at the patient level. The hospitals, standardized computer code terminology, which was then merged with administrative data. We evaluated the ability of the merged data to improve APRDRG ROM predictions. RESULTS: We describe the procedures that the laboratory information systems used to link the electronic laboratory data with standard claims data. The addition of 11 clinical laboratory test results increased the C statistic by 0.574% and R2 by 4.53%. CONCLUSIONS: This study supports the feasibility of linking laboratory data elements with claims-based administrative data to enhance ROM assessments. This linkage resulted in modest statistical improvement in a commonly used ROM model.

[Clinical laboratory guidelines beneficial for Japanese people].

Recently, people are suffering from information overload, especially in the field of health care. Since 2007, we have been performing the duties of a nonprofit organization (NPO), the Standard Clinical Information Center. The purpose of this NPO is to make available standard clinical information based on various clinical guidelines, including JSLM2009, to the public. In 2005, we launched our website, in which easy-to-learn information on common clinical laboratory tests was presented. Through our actions, we have found that there are some problems with JSLM2009, as follows. The principal benefit of guidelines should be to improve the quality of care received by patients. However, JSLM2009 is too complicated to apply to daily clinical practice. The contents are too numerous and redundant. It resembles a textbook. The guideline refers to many other clinical guidelines. However, in those guidelines, evidence about what to recommend is often lacking, misleading, or misinterpreted. These problems should be overcome in the near future.

A Lab-EMR interoperability profile as an eHealth architecture component for resource-constrained settings.

Implementation of computerized systems in resource-constrained settings have been gaining traction as a means of improving the delivery of health care, the use and reuse of information, and providing a standards-based capacity for assessing the process and impact of health care. In a resource-constrained environment, systems are often implemented as stand-alone entities focused on specific care activities (for example, delivering antiretroviral therapy). As such, in many countries, taking a generalized approach to linking electronic medical record systems with laboratory information systems (EMR-LIS) is an important area in which to achieve interoperability. In this paper we describe a scenario of use and information interaction interoperability profile based on our experience implementing EMR-LIS integration in two resource-constrained settings. Of significance, the profile emphasizes queued matching in order to avoid mutual dependence while achieving interoperability between systems.

Digital workflow management for quality assessment in pathology.

Information systems (IS) are well established in the multitude of departments and practices of pathology. Apart from being a collection of doctor's reports, IS can be used to organize and evaluate workflow processes. We report on such a digital workflow management using IS at the Department of Pathology, University Hospital Magdeburg, Germany, and present an evaluation of workflow data collected over a whole year. This allows us to measure workflow processes and to distinguish the effects of alterations in the workflow for quality assessment. Moreover, digital workflow management provides the basis for the integration of diagnostic virtual microscopy.

Offering integrated medical equipment management in an application service provider model.

With the advancement of medical technology and thus the complexity of the equipment under their care, clinical engineering departments (CEDs) must continue to make use of computerized tools in the management of departmental activities. Authors of this paper designed, installed, and implemented an application service provider (ASP) model at the laboratory level to offer value added management tools in an online format to CEDs. The project, designed to investigate how to help meet demands across multiple healthcare organizations and provide a means of access for organizations that otherwise might not be able to take advantage of the benefits of those tools, has been well received. Ten hospitals have requested the service, and five of those are ready to proceed with the implementation of the ASP. With the proposed centralized system architecture, the model has shown promise in reducing network infrastructure labor and equipment costs, benchmarking of equipment performance indicators, and developing avenues for proper and timely problem reporting. The following is a detailed description of the design process from conception to implementation of the five main software modules and supporting system architecture.

Laboratory medicine: challenges and opportunities.

Technologic innovations have substantially improved the productivity of clinical laboratories, but the services provided by clinical laboratories are increasingly becoming commoditized. We reflect on how current developments may affect the future of laboratory medicine and how to deal with these changes. We argue that to be prepared for the future, clinical laboratories should enhance efficiency and reduce costs by forming alliances and networks; consolidating, integrating, or outsourcing; and more importantly, create additional value by providing knowledge services related to in vitro diagnostics.

Using automated clinical data for risk adjustment: development and validation of six disease-specific mortality predictive models for pay-for-performance.

BACKGROUND: Clinically plausible risk-adjustment methods are needed to implement pay-for-performance protocols. Because billing data lacks clinical precision, may be gamed, and chart abstraction is costly, we sought to develop predictive models for mortality that maximally used automated laboratory data and intentionally minimized the use of administrative data (Laboratory Models). We also evaluated the additional value of vital signs and altered mental status (Full Models). METHODS: Six models predicting in-hospital mortality for ischemic and hemorrhagic stroke, pneumonia, myocardial infarction, heart failure, and septicemia were derived from 194,903 admissions in 2000-2003 across 71 hospitals that imported laboratory data. Demographics, admission-based labs, International Classification of Diseases (ICD)-9 variables, vital signs, and altered mental status were sequentially entered as covariates. Models were validated using abstractions (629,490 admissions) from 195 hospitals. Finally, we constructed hierarchical models to compare hospital performance using the Laboratory Models and the Full Models. RESULTS: Model c-statistics ranged from 0.81 to 0.89. As constructed, laboratory findings contributed more to the prediction of death compared with any other risk factor characteristic groups across most models except for stroke, where altered mental status was more important. Laboratory variables were between 2 and 67 times more important in predicting mortality than ICD-9 variables. The hospital-level risk-standardized mortality rates derived from the Laboratory Models were highly correlated with the results derived from the Full Models (average rho = 0.92). CONCLUSIONS: Mortality can be well predicted using models that maximize reliance on objective pathophysiologic variables whereas minimizing input from billing data. Such models should be less susceptible to the vagaries of billing information and inexpensive to implement.

Medical errors: impact on clinical laboratories and other critical areas.

The Institute of Medicine (IOM) report (1999) stated that the prevalence of medical errors is high in today's health care system. Some specialties in health care are more risky than others. A varying blunder/error rate of 0.1-9.3% in clinical diagnostic laboratories has been reported in the literature. Many of these errors occur in the preanalytical and postanalytical phases of testing. It has been suggested that the errors occurring in clinical diagnostic laboratories are smaller in number than those occurring elsewhere in a hospital setting. However, given the quantum of laboratory tests used in health care, even this small rate may reflect a large number of errors. The surgical specialties, emergency rooms, and intensive care units have been previously identified as areas of risk for patient safety. Though the nature of work in these specialties and their interdependence on clinical diagnostic laboratories presents abundant opportunities for error-generating behavior, many of these errors may be preventable. Appropriate attention to system factors involved in these errors and designing intelligent system approaches may help control and eliminate many of these errors in health care.

Corrections of clinical chemistry test results in a laboratory information system.

CONTEXT: The recently released reports by the Institute of Medicine, To Err Is Human and Patient Safety, have received national attention because of their focus on the problem of medical errors. Although a small number of studies have reported on errors in general clinical laboratories, there are, to our knowledge, no reported studies that focus on errors in pediatric clinical laboratory testing. OBJECTIVE: To characterize the errors that have caused corrections to have to be made in pediatric clinical chemistry results in the laboratory information system, Misys. To provide initial data on the errors detected in pediatric clinical chemistry laboratories in order to improve patient safety in pediatric health care. DESIGN: All clinical chemistry staff members were informed of the study and were requested to report in writing when a correction was made in the laboratory information system, Misys. Errors were detected either by the clinicians (the results did not fit the patients' clinical conditions) or by the laboratory technologists (the results were double-checked, and the worksheets were carefully examined twice a day). No incident that was discovered before or during the final validation was included. On each Monday of the study, we generated a report from Misys that listed all of the corrections made during the previous week. We then categorized the corrections according to the types and stages of the incidents that led to the corrections. RESULTS: A total of 187 incidents were detected during the 10-month study, representing a 0.26% error detection rate per requisition. The distribution of the detected incidents included 31 (17%) preanalytic incidents, 46 (25%) analytic incidents, and 110 (59%) postanalytic incidents. The errors related to noninterfaced tests accounted for 50% of the total incidents and for 37% of the affected tests and orderable panels, while the noninterfaced tests and panels accounted for 17% of the total test volume in our laboratory. CONCLUSION: This pilot study provided the rate and categories of errors detected in a pediatric clinical chemistry laboratory based on the corrections of results in the laboratory information system. A direct interface of the instruments to the laboratory information system showed that it had favorable effects on reducing laboratory errors.