Laboratory Informatics Research Articles

B-133 Uric acid: A description of the values found in adult patients treated during 2022 in a High Complexity Hospital

Abstract Background An association between uric acid and kidney disease, glucose intolerance, high blood pressure, metabolic syndrome and cardiovascular disease has been recognized. It is the obligation of the Clinical Laboratory to have valid reference intervals (RI) for this marker. Each particular population has genetics and a diet that represents it, which cannot be extrapolated in many cases. The difficulty and high cost of using direct methods for its establishment drive us to use the existing data in our electronic archive retrospectively. Objective: to describe the range of uric acid values in adult outpatients treated at the Posadas Hospital during the year 2022. Evaluate the influence of gender and age range on the observed values. Methods A retrospective observational approach was carried out from the System database Laboratory Informatics (SIL), Roche Infinity, from the year 2022. The data corresponding to all adult outpatient patients treated in the service were processed. Analytical System: Roche Cobas 6000, Uricase-Oxidase method. Exclusion criteria: oncology patients, kidney patients, diabetics, hyperglycemic patients, obstetric patients, hormonal patients, treated in wards and referred patients. Outliers excluded by Tukey method. The statistical treatment was carried out with the SPSS 17.0 program. Results We worked with 91922 data groups. Hence 12331 of uric acid. After meeting the exclusion criteria: 3899, of which 2289 (3.96 ± 1.05 mg/dl) correspond to women < 50 years , 747 (4.36 ± 1.15 mg/dl at ≥ 50 years and 863 (5.59 ± 1.33 mg/dl) men, all with normal distributions. Applying ANOVA and Student's test it was possible to verify in addition to the described significant difference between sexes, a difference between the 2 age groups of women (p<0.01) which is not equal to that of men in women ≥ 50 years of age. Conclusions A more extensive study is necessary to define own reference ranges that enable the early alarm guidelines, especially in the group of women < 50 years of age. This will allow an adequate evaluation of risk and evolution of patients. The application of Indirect Methods will make it possible to exclude values corresponding to underlying pathologies not registered in the SIL.

B-128 Delivering Predictable Operational efficiency gains at our core central reference laboratory with strategic deployment of navify® Lab Operation informatics automation solution

Abstract Background Metropolis Healthcare Limited (‘MHL’) operates a network of 200 clinical labs in India, our Global Reference Lab (GRL) in Mumbai processes over 25000 tests in a 17 hour daily operation. We are an ISO15189 and CAP accredited laboratory. Our strategic goals have been to bring operational standardization across the network & Improve speed of service with a predictable 90 percentile production TAT. To achieve this goal, we chose digitalization of our laboratory operation with the deployment of navify ® Lab Operations informatics automation solution in. This poster explains our journey of planning, implementing, and delivering on our goal of predictable operational efficiency. The digital solution is at the forefront of all digitalization IQC processes, auto validation and auto approval of patient results passing through a framework of autoverification rules and complete traceability of processes. Methods The poster will explain the scope, planning and implementation approach of this digital automation project at Global reference Lab in 5 stepsHL7 order structure for communication between LIS and navify ® Lab Operations22 analyzers from 11 different manufacturers being connected to the Informatics solution. the corresponding testingTest & IQC (Internal Quality Control) Master with specific ranges and rules10 steps AV (Auto verification) Rules decision framework of concentric sieves across lab disciplines (155 AV Algorithms have been configured at GRL)Structured user acceptance testing framework before Go Live. Results This poster discusses the outcomes that we have seen on deployment of this digital solution.Over 25,000 test results are subject AV engine daily with AV rate of 75 % of all results in Biochemistry, Immunoassays.66 % of all Complete Blood Count (CBC) reports 95 % of all HbA1c results 93 % of all ESR resultsOver 1750 QC results are subject to QC rules dailyThere is an improvement of 4 hours observed in production TAT Conclusions Laboratory Informatics solution has enhanced lab performance in terms of TAT & efficiency of review. The staff satisfaction (both technical and medical) has increased and we see an impact on production outcome. The poster will also show an incremental effectiveness analysis by comparing key performance areas such as predictability in production, staff time saved, before and after technology deployment.

Interpretation of TSH results can be improved by reference values fluctuating in time.

The secretion of thyroid stimulating hormone (thyrotropin, TSH), is characterized by a marked circadian rhythm. Plasma or serum TSH values are significantly lower in the afternoon and in the evening as compared to the early morning. As in clinical practice, blood sampling time shows an important variation, a reliable assessment of thyroid status is often not an easy task for the clinician. The biological variation of TSH plays a major role in the intra-individual variability of TSH results in serum or plasma. The observed intra-day variation largely exceeds the reported inter-vendor variation and the coefficient of variation of clinical TSH assays. Therefore, a mathematical solution was sought for correcting interpretation of TSH results for sampling time. We have developed a cosinor model which allows to compensate TSH decision values for the fluctuating serum or plasma TSH concentrations throughout the day. The following mathematical function could be derived: corrected TSH cutoff_value (mIU/L)=0.40+0.24*cos(((π/12) *T)+6) in which T represents the time (hours). This mathematical function can be easily implemented into a laboratory's informatics system and furthermore allows a better tailored diagnosis of (subclinical) hyperthyroidism, regardless the blood sampling time. Implementing the corrected cut-off values result in a marked reduction of apparent (false positive) hyperthyroidism diagnosis, in particular in the afternoon.

Accuracy-Based Glomerular Filtration Rate Assessment by Plasma Iohexol Clearance in Kidney Transplant Donors.

An accurate measurement of the glomerular filtration rate (GFR) is essential for detecting renal insufficiency in living kidney donors. Iohexol is a "near-ideal" exogenous filtration marker for GFR measurements that has attracted increasing interest in clinical practice because it is non-toxic, non-radioactive, readily available, and easy to measure. In this study, we aimed to set up a laboratory test to conveniently assess the plasma clearance of iohexol in living kidney donors. A workflow was established in the institution's infusion clinic to administer iohexol and to collect three timed blood samples from renal transplant donors. Iohexol was thereafter measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS). The serum proteins were precipitated and the supernatant containing iohexol was diluted prior to the LC-MS/MS analysis. The LC-MS/MS method was developed on a Thermo Vanquish UHPLC coupled with a TSQ Endura triple quadruple mass spectrometer with a total run time of 2.5 min. The analytical performance of the method was assessed. The LC-MS/MS method demonstrated a good analytical performance. To calculate the iohexol clearance rate and the GFR, automated data integration and a result calculation were accomplished by using a custom Python script. Automated result reporting was achieved using a laboratory informatics system (LIS) vendor's direct media interface. We developed and implemented a laboratory test to assess the plasma clearance of iohexol. A workflow was established in the hospital to reliably measure the GFR in living kidney donors, with a potential to be further expanded into other areas where an accurate GFR measurement is needed.

Innovation, Automation and Informatics Improves Quality in Lerdsin Hospital, Thailand.

This paper describes a planned, continuous improvement journey, of a laboratory that has installed a system with a single sample touch from blood draw to result. To achieve this, physical connectivity of systems from phlebotomy through pre-analytical to the analytical phase were paired with informatics connectivity from the patient's national identity card to the hospital and laboratory informatics management systems (LIMS) and associated middleware. This allowed accurate time stamps to track turnaround time (TAT). TAT metrics were collected from the LIMS for inpatient, emergency room and outpatient samples and tests over a period of 7months. This time span incorporated the 2-month period before automation was implemented. The results for all tests and specific tests are shown and the results of an analysis of the outpatient phlebotomy workflow are given. The implemented solution has improved outpatient TAT by over 54% and has shown that samples can be collected, and results obtained without touching the sample. Improving intra-laboratory TAT is an important quality goal for all laboratories. The implementation of automation is important in achieving this albeit more about obtaining predictable TAT. Automation does not necessarily improve TAT it removes variation which leads to predictable TAT (PTAT). Automation should only be considered with a strategic vision for the future as it is important to have clear goals and objectives based on the individual laboratories process and needs. Automating a poor process leads to an automated poor process. Here, an innovative use of automation, hardware and software has resulted in marked improvement in TAT across all samples processed in the central laboratory.

Application of Virtual Assistant in Information System for Student Practicum Case Study Laboratory Informatics Department Siliwangi University

Practical activities are carried out in an orderly and timely manner and require systematic recording of activities. The implementation of practicum activities takes place in the Siliwangi University laboratory, to create conducive conditions for practicum activities, a system must be able to support academic success. Not only that, due to the COVID-19 pandemic, previous practicum lectures were held offline and campus policy required online learning. These problems can be overcome by building a logbook information system that can record and keep records of laboratory activities automatically. This information system was created using the Extreme Programming system development method. Starting from database design, system design with UML, system development with Visual Studio. NET 2021. This technology can be used by universities for practical activities at the Siliwangi University Laboratory. The application will remind students to complete each activity in each session by displaying notifications in each practicum schedule, rewards, announcements, and other information related to practicum activities. All activities must be recorded in the application. Based on the results of black box testing, the system can run according to the system test design that the response from each student to the application used is 75.68% which can be concluded that the application of virtual assistant is in the interesting category.

Clinical Laboratory Informatics and Analytics: Challenges and Opportunities.

The American Medical Informatics Association defines biomedical and health informatics as the “science of how to use data, information, and knowledge to improve human health and the delivery of health care services.” More specifically within laboratory medicine, informatics and data analytics use multiple sources of data to improve all aspects of the clinical laboratory, from workflow and personnel to result interpretation. With increasing healthcare information complexity, integration and interoperability issues have become readily apparent between health information systems, bringing to the forefront questions about the validity of data exchange and basic data access. Most data generated within the clinical laboratory are of high quality, well annotated, and structured discretely, however turning these data into useful and actionable information can be a difficult data analytics bridge for many to cross. Instrument and laboratory information system (LIS) vendors are beginning to aid in the creation of generalized reports for common laboratories questions; however, this still falls short of the potential of the clinical laboratory to bring more actionable information to hospital leadership, clinicians, and patients. Collaboration among informaticians, information technology (IT) professionals, and the laboratorians is critical to ensure our health information systems can utilize and report laboratory data clinically, in addition to providing interoperable data streams for furthering research, education, and innovation in healthcare.

Laboratory Informatics in COVID-19 Pandemic Era

Data and information technology is a key component in responding to covid-19 disease and is an effective way for informing personnel, resource management, and inter-intra organizational communication. During the pandemic, technology-based tools enable organizations to facilitate the widespread information dissemination, real-time tracking, meetings and daily activities virtualization and telemedicine visits for patients, physicians, and other health care providers as a major risk group of Covid-19. In response to pandemic conditions, hospital leaders can use clinical informatics to assist in decision making, medical care virtualizing and workflows defining. Among them, the informatics team is considered as a supporter and facilitator in providing new care methods, helping to track and predicting the impact of relevant data.

Evolving Applications of Artificial Intelligence and Machine Learning in Infectious Diseases Testing.

BackgroundArtificial intelligence (AI) and machine learning (ML) are poised to transform infectious disease testing. Uniquely, infectious disease testing is technologically diverse spaces in laboratory medicine, where multiple platforms and approaches may be required to support clinical decision-making. Despite advances in laboratory informatics, the vast array of infectious disease data is constrained by human analytical limitations. Machine learning can exploit multiple data streams, including but not limited to laboratory information and overcome human limitations to provide physicians with predictive and actionable results. As a quickly evolving area of computer science, laboratory professionals should become aware of AI/ML applications for infectious disease testing as more platforms are become commercially available.ContentIn this review we: (a) define both AI/ML, (b) provide an overview of common ML approaches used in laboratory medicine, (c) describe the current AI/ML landscape as it relates infectious disease testing, and (d) discuss the future evolution AI/ML for infectious disease testing in both laboratory and point-of-care applications.SummaryThe review provides an important educational overview of AI/ML technique in the context of infectious disease testing. This includes supervised ML approaches, which are frequently used in laboratory medicine applications including infectious diseases, such as COVID-19, sepsis, hepatitis, malaria, meningitis, Lyme disease, and tuberculosis. We also apply the concept of “data fusion” describing the future of laboratory testing where multiple data streams are integrated by AI/ML to provide actionable clinical knowledge.

Value-Based Intervention with Hospital and Pathology Laboratory Informatics: A Case of Analytics and Outreach at the Veterans Affairs

Background: Laboratory tests are among the most ordered tests and account for a large portion of wasted health-care spending. Meta-analyses suggest that the most promising interventions at improving health-care value and reducing cost are low investment strategies involving simple changes to ordering systems. The veterans affairs (VA) has a 2018-2024 strategic objective to reduce wasted spending through data- and performance-focused decision-making. Methods: VA Palo Alto Healthcare System laboratory utilization data were obtained from multiple sources, including the VA Corporate Data Warehouse and utilization reports from reference laboratory. Ordering volume, test results, and follow-up clinical impact data were collected and evaluated in partnership with the treating physicians and hospital informatics in order to optimize ordering sets. Results: Dextromethorphan (Dext) and synthetic cannabinoid testing were identified as the lowest value tests based on a three-tier score of negativity rate, volume, and cost. In partnership with the ordering physicians and hospital informatics, reflexive testing was eliminated, resulting in persistent decreases in the volume of Dext (162-10 tests/month) and synthetic cannabinoid tests (155-19 tests/month) ordered. The proportion of unnecessary repeat tests also dropped from 71.5% to 5.5%, the test positivity rate increased from 0.87% to 3.49%, and the approximate monthly cost of both tests decreased ten-fold from $21,250 to $2087 for a yearly savings of $229,000 at a single VA. Conclusions: Improved laboratory utilization is central to the VA’ strategic objective to reduce waste. A relatively simple intervention involving partnership with the treating physicians and hospital informatics in combination with data- and performance-focused decision-making can yield substantial reductions in health-care waste.

Clinical Impact of 21-Gene Recurrence Score Test Within the Veterans Health Administration: Utilization and Receipt of Guideline-Concordant Care

IntroductionEnsuring guideline-concordant cancer care is a Department of Veterans Affairs (VA) priority, especially as the number of breast cancer patients at VA medical centers (VAMCs) grows. We assessed the utilization and clinical impact of the 21-gene Recurrence Score test, which predicts 10-year risk of breast cancer recurrence and the likelihood of chemotherapy benefit, on veterans newly diagnosed with breast cancer. Patients and MethodsWe conducted a retrospective cohort study using 2011-2012 VA Central Cancer Registry, chart review, and laboratory test data. Independent variables assessed included patient and site-of-care characteristics. The outcome of interest was whether newly diagnosed, eligible (node negative, hormone-receptor positive, human epidermal growth factor receptor 2 [HER2] negative) veterans underwent the 21-gene test. We performed descriptive statistics on all patients and multivariate logistic regression to determine associations. We correlated treatments received with test results. ResultsAmong 328 eligible veterans, 82 (25%) had the 21-gene test; 100 eligible veterans (30%) sought care at a VAMC where no tests were ordered. Receiving care at a VAMC that had women's health services (odds ratio [OR], 1.84, 95% confidence interval [CI], 1.05-3.22) and having tumor characteristics meeting the National Comprehensive Cancer Network 2010 test criteria (OR, 3.06, 95% CI, 1.69-5.57) were positive predictors of testing; increasing age (OR, 0.93, 95% CI, 0.91-0.96 per year) and fee-based care (OR, 0.46, 95% CI, 0.26-0.82) were negative predictors. The majority of tested patients received guideline-concordant care. ConclusionSite of care and tumor characteristics were important predictors of test uptake. Facilitating delivery of guideline-concordant cancer care requires improved laboratory informatics and clinical decision support.

Sociodemographic Correlates of Clinical Laboratory Test Expenditures in a Major Canadian City

The increasing cost of clinical laboratory testing is a challenge in our health care system. This study aims to calculate the annual clinical laboratory test costs attributed to patients in a major Canadian city and to correlate them to their sociodemographic variables. Retrospective cohort study involving patients who received clinical chemistry, hematology, and microbiology tests in 2011 in Calgary, Canada (n = 610,409). Test volumes were obtained from a laboratory informatics database. Total expenditures per patient were calculated using estimated test costs and then combined with the 2011 Canadian Census Household Survey results to infer sociodemographic correlates. While more women received laboratory testing (58.4%), men had slightly higher testing costs per capita. Except for Chinese, visible minority and Aboriginal populations had higher testing costs. There was an inverse correlation between testing cost and household income, and accordingly, higher costs were found in those without postsecondary education and the unemployed. Furthermore, hotspot mapping revealed the geographical distribution of patient test costs within the city. There is variation in testing costs for patients among different sociodemographic variables.

Open-source LIMS in Vietnam: The path toward sustainability and host country ownership

ObjectiveThe objectives of this case report are as follows: to describe the process of establishing a national laboratory information management system (LIMS) program for clinical and public health laboratories in Vietnam; to evaluate the outcomes and lessons learned; and to present a model for sustainability based on the program outcomes that could be applied to diverse laboratory programs. MethodsThis case report comprises a review of program documentation and records, including planning and budgetary records of the donor, monthly reports from the implementer, direct observation, and ad-hoc field reports from technical advisors and governmental agencies. Additional data on program efficacy and user acceptance were collected from routine monitoring of laboratory policies and operational practices. ResultsLIMS software was implemented at 38 hospital, public health and HIV testing laboratories in Vietnam. This LIMS was accepted by users and program managers as a useful tool to support laboratory processes. Implementation cost per laboratory and average duration of deployment decreased over time, and project stakeholders initiated transition of financing (from the donor to local institutions) and of system maintenance functions (from the implementer to governmental and site-level staff). Collaboration between the implementer in Vietnam and the global LIMS user community was strongly established, and knowledge was successfully transferred to staff within Vietnam. ConclusionImplementing open-sourced LIMS with local development and support was a feasible approach towards establishing a sustainable laboratory informatics program that met the needs of health laboratories in Vietnam. Further effort to institutionalize IT support capacity within key government agencies is ongoing.

Inappropriate repeats of six common tests in a Canadian city: a population cohort study within a laboratory informatics framework.

To identify inappropriate repeats of six common laboratory tests in a population sample of patients, using highly specific criteria based only on repeat time and test value. We used a laboratory informatics database to conduct a retrospective cohort study using a population sample of 103,000 patients in the city of Calgary with an index test in 2010 and uniform follow-up of 1 year. We examined six tests (cholesterol, hemoglobin A1c, thyroid-stimulating hormone, vitamin B12, vitamin D, and ferritin) with consensus-based or easily justified criteria for inappropriate repeats based solely on time to repeat and the index test value. The percentages of tests repeated at 3, 6, and 12 months were 11%, 23%, and 41%, respectively. In total, 16% of these six tests were inappropriately repeated, representing an annual internal cost of $0.6 to $2.2 million Canadian dollars and corresponding to population-scaled national estimates for Canada and the United States of $160 million and $2.4 billion, respectively. Objective definitions based on repeated testing identified 16% of six studied tests as inappropriate, delineating a subset of inappropriate testing that is well suited to automated identification and intervention and that provides a likely lower bound on the true burden of inappropriate testing.

Method transfer between bioanalytical laboratories.

Method transfer between bioanalytical laboratories.

The potential impact of laboratory informatics on technology transfer.

The potential impact of laboratory informatics on technology transfer.

Why hold a congress of Laboratory Medicine in Brazil?

Sociedade Brasileira de Patologia Clinica/Medicina Laboratorial (SBPC/ML) annually holds a Brazilian congress on its specialty. But why? The reasons are innumerable. At a scientific congress one can keep up-to-date and meet colleagues from other regions of the country and of the world. Technical scientific updating in the medical area is fundamental, considering that significant modifications rapidly occur in diagnostic procedures, with the development of more robust methods, and the exploitation of novel resources of automation and computing. It is in congresses that novelties are presented, either by well-qualified speakers, in lectures, conferences and round-table discussions, or by input and equipment companies. During such events, the possibilities are huge for exchange and acquisition of knowledge, directly from the generating sources, by the presence of eminent researchers.Meeting colleagues is always a reason for satisfaction and rejoicing; it strengthens friendship ties, and allows the sharing of everyday experiences. Interaction, though for just three or four days, with professionals from different areas of laboratory diagnosis, and from other medical specialties that make frequent use of the clinical laboratory, creates a highly productive setting where benefits and limitations can be clearly and informally discussed.Companies, manufacturers or distributers of input and equipment actively participate in the success of the congress by organizing a trade fair, where they display state-of-the-art devices, systems and methodologies. It is the opportunity not only to learn what is being presented, but to negotiate trade agreements.Soon, from September 29 to October 2, in Fortaleza, Ceara, the 49th Brazilian Congress of Clinical Pathology/Laboratory Medicine and the 1st Brazilian Congress of Laboratory Informatics will be held. The choice of Fortaleza as their seat was a dream come true for clinical pathologists and laboratory workers from the whole Northeast region of Brazil.The main theme of the Laboratory Medicine Congress will be “Integration for diagnosis”. It is the view that currently guides Laboratory Medicine, prizing integration among professionals from different areas and reflecting the reality of our days, with growing integration among the several diagnostic tools.The 1st Brazilian Congress of Laboratory Informatics will convene activities related to information technology in its own and simultaneous meeting, lasting one day, when participants will improve their knowledge without missing the scientific program of the event as a whole. For both congresses, 170 Brazilian and 10 foreign speakers are invited. A total of 24 conferences will be held, besides 45 round-table discussions, covering all areas of Laboratory Medicine. Approximately 122 companies, including manufacturers and distributors of clinical laboratory products, governmental entities of education and health, and private laboratories will be present, actively participating in all the activities.The chosen place, Centro de Eventos do Ceara (CEC), opened in 2012, is considered the most modern and well-equipped venue for events of this nature. The center has the ideal infrastructure for the congress, with a wide area for technical-scientific exhibitions, rooms, auditoriums, lounges and circulation areas that ensure participants’ comfort.In addition, the capital of Ceara, with many tourist attractions, has excellent hotel and restaurant facilities to host big events. The increased frequency of direct flights between Fortaleza (Aeroporto Internacional Pinto Martins) and European countries encouraged the participation of many foreign guests.Welcome and enjoy Fortaleza.

Screening and Management of Hepatitis B Virus before the First Rituximab Infusion: We Must Do Better!

Rituximab, a chimeric monoclonal antibody directed against the CD20 antigen is widely used for the treatment of B-cell malignancies and others auto immune pathologies.HBV reactivation is a well known life-threatening complication of rituximab. In 2004, US FDA recommended HBV screening of high risk patients before the first Rituximab infusion and treatment of patients with positive hepatitis B surface antigen or antibody to hepatitis B core. Then in 2008, CDC recommended screening of all patients. EASL in 2012 recommended treating patients with positive HBsAg or anti-HBc.The aim of this study was to evaluate HBV screening and management before the initiation of rituximab.We conducted a retrospective monocentric study in Argenteuil Hospital, located in the neighborhood of Paris, France. All patients who received rituximab between January 1, 2008 and December 31, 2013 were included. The list was exhaustive through the Pharmacy Informatics. Laboratory Informatics gave test dates and results for hepatitis B surface antigen (HBsAg), antibody to hepatitis B core antibody (anti-HBc) and antibody to hepatitis B surface (anti-HBs). We investigated for medical record when serology was missing. We considered serology as not done when no result was found.The data are described as number and percentages for categorical variables and mean ± standard deviation or median for continuous variables. Between-group comparisons were done using the chi-square test for categorical data and Student t-test for continuous data. P values <0.05 were considered statistically significant. Statistical analysis was performed with R software (http://cran-project.org).We included 509 patients with a mean age of 65.5 when rituximab treatment was initiated. Men represented 58% and 33% of patients were born outside of France, mainly in Africa or in Asia. Rituximab was mainly used in cancer treatment (91%) and chemotherapy was associated in 82% of cases.Five medical records were lost, so the study was conducted for 504 patients. The rate of assessment for HBV serology was 79.4% (104 not done among the 504). Sex, country of origin, indication for treatment or cancer were not statistically significant for the quality of screening. No difference was found depending on the period. A trend in favor a worst screening for older patients was seen: median age for screening patients was 64.8 versus 68.1 (p=0.053).Among the 9 patients who were HBsAg+, 8 received analogue nucleoside and did not reactivate HBV. These patients have also been screened for Hepatitis Delta virus. The patient who did not receive a preemptive therapy reactivated HBV. This patient was initially treated in another center without HBV screening. When he was referred to us an important hepatic flare secondary to HBV reactivation was found. Six among the 11 patients who were anti-HBc+ /antiHBs- received preemptive therapy and no reactivation was seen. Adenofovir then tenofovir was chosen preferentially. None of the patients with anti-HBc and anti-HBs received preemptive antiviral therapy as recommended since 2004. Among them, one patient treated with rituximab and chlorambucil for CLL reactivated HBV. Evolution was favorable on entecavir.To summarize, our HBV management before Rituximab first infusion must be improved. All patients with HBc with or without HBs antibody are of risk of HBV reactivation. Pre-emptive treatment should be proposed to all patients with HBc positive antibody. DisclosuresNo relevant conflicts of interest to declare.

Developing A Strategy for A Regulated Electronic Bioanalytical Laboratory

This perspective article considers the strategy, design and implementation of an electronic bioanalytical laboratory working to GLP and/or GCP regulations. There are a range of available automated systems and laboratory informatics that could be implemented and integrated to make an electronic laboratory. However, which are the appropriate ones to select and what is realistic and cost-effective for an individual laboratory? The answer is to develop an overall automation strategy that is updated periodically after each system or application has been implemented to assess if the strategy is still valid or needs to be changed. As many laboratory informatics applications have functional overlap or convergence, for example, Laboratory Information Management System, Electronic Laboratory Notebook, and Instrument and Chromatography Data Systems, the decision of which application performs a specific task needs to be carefully considered in the overall strategy. Ensuring data integrity and regulatory compliance, especially in light of a number of recent falsification cases, is a mandatory consideration for the overall strategy for an electronic bioanalytical laboratory submitting data to regulatory authorities.

Effective Integration of Informatics Tools to Enhance the Drug Discovery Process

Effective integration of data and laboratory informatics tools promises the ability for organizations to make better informed decisions about resource allocation during the drug discovery and development process, and for more informed decisions to be made with respect to the market opportunity for compounds. There are technologies on the horizon that could dramatically change how informatics organizations design, develop, deliver, and support applications and data infrastructures to deliver maximum value to drug discovery organizations. There are numerous benefits of integrating laboratory informatics tools like Laboratory Information Management System (LIMS), Chromatographic Data Systems (CDS), Electronic Laboratory Notebooks (ELN), and Analytical Instrumentation and Scientific Data Management Systems (SDMS) for drug discovery processes, but there is no well-established path for effective integration of these tools. We propose in this article four new integration models for effective integration of labor...