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Background Delay or failure to view test results in a hospital setting can lead to delayed diagnosis, risk of patient harm, and represents inefficiency. Factors influencing this were investigated to identify how timeliness and completeness of test review could be improved through an evidence-based redesign of the use of clinical test review software. Methods A cross-section of all abnormal hematology and biochemistry results which were published on a digital test review platform over a 3-year period were investigated. The time it took for clinicians to view these results, and the results that were not viewed within 30 days, were analyzed relative to time of the week, the detailed type of test, and an indicator of patient record data quality. Results The majority of results were viewed within 90 min, and 93.9% of these results viewed on the digital platform within 30 days. There was significant variation in results review throughout the week, shown to be due to an interplay between technical and clinical workflow factors. Routine results were less likely to be reviewed, as were those with patient record data quality issues. Conclusion The evidence suggests that test result review would be improved by stream-lining access to the result platform, differentiating between urgent and routine results, improving handover of responsibility for result review, and improving search for temporary patient records. Altering the timing of phlebotomy rounds and a review of the appropriateness of routine test requests at the weekend may also improve result review rates.

Background In Korea, the Korean Laboratory Accreditation Program (KLAP) has set minimum standards for verification of clinical test performance. This verification process is time-consuming and labor-intensive when performed manually. We developed a free, statistical software program for KLAP, using the R language (R Foundation for Statistical Computing, Vienna, Austria). Methods We used CLSI guidelines for the algorithm. We built graphic user interfaces, including data input, with Embarcadero Delphi EX4 (Embarcadero Technologies, Inc., Texas, USA). The R Base Package and MCR Package for Method Comparison Regression were used to implement statistical and graphical procedures. Results Our program LaboStats has six modules: parallel test, linearity, method comparison, precision, reference interval, and cutoff. Data can be entered into the field either manually or by copying and pasting from an MS Excel worksheet. Users can print out precise reports. Conclusions LaboStats can be useful for evaluating clinical test performance characteristics and preparing documents requested by KLAP.

Introduction and Objective: In laboratory, the errors related to the total testing process, affecting clinical decision making, may occur in all the phases. Quality Indicators are fundamental tool to assess the laboratory performance. The aim of this study is to observe the error types and rates for analytical and post analytical phase inorder to assess laboratory performance and rectify them. In addition to acrreditate laboratory as per international standards, it would also help to improve patient care and safety. Materials and Methods: For a period of one year, errors were observed, recorded and analyzed at clinical Biochemistry laboratory, SMIMER, Surat by this retrospective study. Data analysis of total 907611 tests carried out on 317212 samples was done. Analytical and post analytical errors were identified; recorded and analysed taking into consideration certain related Quality Indicators. Results: For analytical phase and post analytical phase error rates recorded were 7.51% and 8.57% of total samples respectively while it was observed to be as high as 46.71% and 53.28% respectively against total errors encountered for the phases. Highest (45.9%) error rate of analytical phase error was due to tests not in conformance with External Quality Assurance - Proficiency Testing scheme in a previously treated cause. 17.52% of post analytical phase error was due to low rate of critical call outs to clinicians. No records were maintained pertaining to (1) delayed delivery of reports due to insufficient reagents, (2) critical values call out time (min) and (3) staff training events. Also the laboratory was not equipped with Laboratory Informatics System. Conclusion: Quality Indicators based high error rates warrant active intervention and strict supervision of both the phases of TTP under study. Strategic measures should be initiated to minimize the risk of errors. Ultimately it would be useful for betterment of patient care and safety. Keywords: Total testing pr

Antimicrobial resistance (AMR) is a major threat to human health globally. Surveillance is a key activity to determine AMR burden, impacts, and trends and to monitor effects of interventions. Surveillance systems require efficient capture and onward sharing of high-quality laboratory data. Substantial investment is being made to improve laboratory capacity, particularly in low-income and middle-income countries (LMICs) with high disease burdens. However, building capacity for effective laboratory data management remains an under-resourced area, which, unless addressed, will limit progress towards comprehensive AMR surveillance in LMICs. The lack of a fit-for-purpose and open-source laboratory information management system software is of particular concern. In this Personal View, we summarise the technical requirements for microbiology laboratory data management, provide a snapshot of laboratory data management in LMIC laboratories, and describe the key steps required to improve the situation. Without action to improve information technology infrastructure and data management systems in microbiology laboratories, the ongoing efforts to develop capacity for AMR surveillance in LMICs might not realise their full potential.

DNA-encoded libraries (DELs) have emerged as an efficient and cost-effective drug discovery tool for the exploration and screening of very large chemical space using small-molecule collections of unprecedented size. Herein, we report an integrated automation and informatics system designed to enhance the quality, efficiency, and throughput of the production and affinity selection of these libraries. The platform is governed by software developed according to a database-centric architecture to ensure data consistency, integrity, and availability. Through its versatile protocol management functionalities, this application captures the wide diversity of experimental processes involved with DEL technology, keeps track of working protocols in the database, and uses them to command robotic liquid handlers for the synthesis of libraries. This approach provides full traceability of building-blocks and DNA tags in each split-and-pool cycle. Affinity selection experiments and high-throughput sequencing reads are also captured in the database, and the results are automatically deconvoluted and visualized in customizable representations. Researchers can compare results of different experiments and use machine learning methods to discover patterns in data. As of this writing, the platform has been validated through the generation and affinity selection of various libraries, and it has become the cornerstone of the DEL production effort at Lilly.

Patient based real time Quality Control (PBRTQC) algorithms provide many advantages over conventional QC approaches including lower cost, absence of commutability problems, continuous real-time monitoring of performance, and sensitivity to pre-analytical error. However, PBRTQC is not as simple to implement as conventional QC because of the requirement to access patient data as well as setting up appropriate rules, action protocols, and choosing best statistical algorithms. These requirements need capable and flexible laboratory informatics (middleware). In this document, the necessary features of software packages needed to support PBRTQC are discussed as well as recommendations for optimal integration of this technique into laboratory practice.

Background Eicosanoids are metabolites of arachidonic acid that are rapidly biosynthesized and degraded during inflammation, and their metabolic changes reveal altered enzyme expression following drug treatment. We developed an eicosanoid profiling method and evaluated their changes on drug treatment. Methods Simultaneous quantitative profiling of 32 eicosanoids in liver S9 fractions obtained from rabbits with carrageenan-induced inflammation was performed and validated by liquid chromatography-mass spectrometry coupled to anion-exchange solid-phase purification. Results The limit of quantification for the devised method ranged from 0.5 to 20.0 ng/mg protein, and calibration linearity was achieved (R²>0.99). The precision (% CV) and accuracy (% bias) ranged from 4.7 to 10.3% and 88.4 to 110.9%, respectively, and overall recoveries ranged from 58.0 to 105.3%. Our method was then applied and showed that epitestosterone treatment reduced the levels of all eicosanoids that were generated by cyclooxygenases and lipoxygenases. Conclusions Quantitative eicosanoid profiling combined with in vitro metabolic assays may be useful for evaluating metabolic changes affected by drugs during eicosanoid metabolism.

Drug combination testing in the pharmaceutical industry has typically been driven by late-stage opportunistic strategies rather than by early testing to identify drug combinations for clinical investigation that may deliver improved efficacy. A rationale for combinations exists across a number of diseases in which pathway redundancy or resistance to therapeutics are evident. However, early assays are complicated by the absence of both assay formats representative of disease biology and robust infrastructure to screen drug combinations in a medium-throughput capacity. When applying drug combination testing studies, it may be difficult to translate a study design into the required well contents for assay plates because of the number of compounds and concentrations involved. Dispensing these plates increases in difficulty as the number of compounds and concentration points increase and compounds are subsequently rolled onto additional labware. We describe the development of a software tool, in conjunction with the use of acoustic droplet technology, as part of a compound management platform, which allows the design of an assay incorporating combinations of compounds. These enhancements to infrastructure facilitate the design and ordering of assay-ready compound combination plates and the processing of combinations data from high-content organotypic assays.

Background Recent advances in laboratory information systems have largely been focused on automation. However, the phlebotomy services have not been completely automated. To address this issue, we introduced an automated reception and turnaround time (TAT) management system, for the first time in Korea, whereby the patient's information is transmitted directly to the actual phlebotomy site and the TAT for each phlebotomy step can be monitored at a glance. Methods The GNT5 system (Energium Co., Ltd., Korea) was installed in June 2013. The automated reception and TAT management system has been in operation since February 2014. Integration of the automated reception machine with the GNT5 allowed for direct transmission of laboratory order information to the GNT5 without involving any manual reception step. We used the mean TAT from reception to actual phlebotomy as the parameter for evaluating the efficiency of our system. Results Mean TAT decreased from 5:45 min to 2:42 min after operationalization of the system. The mean number of patients in queue decreased from 2.9 to 1.0. Further, the number of cases taking more than five minutes from reception to phlebotomy, defined as the defect rate, decreased from 20.1% to 9.7%. Conclusions The use of automated reception and TAT management system was associated with a decrease of overall TAT and an improved workflow at the phlebotomy room.

Objectives 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. Methods 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. Results 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. Conclusions 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.

Background: The identification of in vitro hemolysis (IVH) using a hematology analyzer is challenging because centrifugation of the specimens cannot be performed for cell counts. In the present study, we aimed to develop a scoring system to help identify the presence of hemolysis in anticoagulated blood specimens. Methods: Thirty-seven potassium EDTA anticoagulated blood specimens were obtained, and each specimen was divided into 3 aliquots (A, B, and C). Aliquots B and C were mechanically hemolyzed by aspirating 2 and 5 times, respectively, using a 27-gauge needle and then tested; aliquot A was analyzed immediately without any hemolysis. After the cells were counted, aliquots B and C were centrifuged and the supernatants were tested for the hemolytic index and lactate dehydrogenase levels. Results: The 4 hematologic parameters were selected and scored from 0 to 3 as follows

Harmonization initiatives in laboratory medicine seek to eliminate or reduce illogical variations in service to patients, clinicians and other healthcare professionals. Significant effort will be required to achieve consistent application of terminology, units and reporting across laboratory testing providers. Current variations in practice for nomenclature, reference intervals, flagging, units, standardization and traceability between analytical methods, and presentation of cumulative result data are inefficient and inconvenient, or worse yet, patient safety risks. All aspects of laboratory service across the “total testing process” ultimately depend on concise, reliable communication. Clinical terminologies (e.g. SNOMED-CT, LOINC, IFCC/IUPAC NPU) provide a mechanism to correctly identify an analyte or panel of tests within a request for testing and communicate the results back to the clinician or electronic health record (EHR). Electronic systems for requesting and reporting laboratory testing are said to be interoperable when reliable connection and communication of content occur. Modern electronic reports and EHRs will provide greater flexibility and functionality, but also require effective guidelines or standards to ensure consistent representation of laboratory data. Programs to harmonize service in these areas require ongoing local, national and international efforts and should incorporate stakeholders from laboratories, medical staff, information technology and informatics specialists, patient representatives and government. The process of identifying harmonized best practice, then ensuring uptake across many laboratory testing providers, is generally iterative rather than “one off”. New opportunities for additional harmonization will be generated as analytical performance, standardization and traceability, and diagnosis and treatment continue to evolve.

Objective The 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. Methods This 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. Results LIMS 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. Conclusion Implementing 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.

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.

Aim Our aim is to evaluate the performance of a computerized virtual crossmatch within the Duke University Medical Center HLA laboratory. Our HLA lab has used virtual crossmatch (vXM) to select deceased donors for heart and lung transplantations for more than ten years, which has allowed us to accept donors from outside of our Organ Procurement Organization territory. The virtual crossmatches were done by manually checking the recipient’s HLA antibody profiles within our lab database against the potential donor’s HLA typing to identify if the recipient has any donor-specific antibodies (DSA) in the most recent serum tested and in historical sera. To ensure no DSA was missed, the vXM was manually done by multiple transplant professionals at different stages for each sensitized recipient when a donor offer was available. Laboratory informatics vendor HLA Data Systems, developers of the mTilda Lab Management System, has developed a stand-alone software program which performs a computerized vXM (cVXM) under the product name VxMatch. The VxMatch program directly connects to any HLA lab database to query required data for analysis. Methods We performed 56 cVXMs by using the new program for patients who had previously received manual vXMs (mVXM) over the past few months. 35 of the 56 patients have calculated panel reactive antibodies (cPRA) = >80%. Results We found a 100% concordance for identification of DSA between cVXM and mVXM. It took less than 5 min to complete the cVXM while the conventional mVXM took 30 min on average. For each identified unacceptable antigen, the cVXM program provides detailed information, including antibody specificities, mean fluorescence intensity (MFI), serum date and a graph showing the MFI changes of DSA over time. The mTilda cVXM can operate in two different modes: a technologist’s level and supervisory level. The supervisory module allows us to review each individual bead carrying potential unacceptable HLA antigen at alpha chain, beta chain, or allele level. This cVXM can also be used to identify the sera (for example the serum with peak DSA) for final XM and the ability to track the change of DSA post-transplant. Conclusion Our evaluation suggests that this new computerized vXM program is a user-friendly, reliable and powerful tool for HLA testing and management.

Directing a cytology laboratory is one of the most complex jobs in the laboratory. The workflow is complex due to the extensive quality assurance and other regulatory requirements imposed by the clinical laboratory improvement Act of 1988 (CLIA 1988) in addition to the usual tasks of accessioning, processing, routing different specimen types appropriately, and reporting. The advent of the CLIA 1988 regulations made it virtually mandatory that cytology laboratories be computerized to effectively manage their workflow and efficiently compile and summarize the quality assurance data necessary to meet the CLIA 1988 mandates. Practical informatics for cytopathology is a brief (204 pages), informative book which provides a succinct introduction to all aspects of informatics pertinent to cytology laboratories. It will be most helpful to the cytotechnologist or cytopathologist who has a directorial or supervisory role and who has the task of interfacing with the computer professionals in a clinic or hospital, or representing the cytology section when a laboratory is evaluating and comparing candidate systems to replace an existing system. It is not a comprehensive textbook covering the topic in sufficient detail for someone training to be a laboratory informatics professional. However, the reader of this book will have a basic understanding of the terminology and concepts of informatics in discussions with information technology professionals. While all of the chapters provide suitable introductions to their topics, several are especially useful for those who are seeking to quickly familiarize themselves with the basic concepts that are relevant to a specific topic. The introductory chapter gives a short overview of the field, mentions the major federal regulatory acts that pertain to laboratory informatics and provides the names and websites of the major professional societies and other resources. The next two chapters cover basic principles of computing and networking at a very basic level, but with enough detail to allow the informatics beginner to have an idea about what is happening “under the hood” in a computer, and to be able to follow the conversation in a system planning meeting with the institution's informatics team. The next chapter discusses various types of databases. This chapter clarifies the distinction between spreadsheets (which are “flat” databases) and other types of databases that are commonly used in laboratories such as hierarchical and relational. This chapter also provides explanations of data warehouses and data mining, both terms which are likely to be heard in discussions of laboratory informatics. The next four chapters address “laboratory information systems (LISs),” “LIS operations and regulations,” “reporting,” and “quality management.” In the aforementioned context of a cytology supervisor or laboratory director who needs to quickly familiarize him or herself with basic concepts of laboratory informatics pertinent to cytopathology, these four chapters are probably the most useful in the book. Chapter 6 covers most of the important concepts necessary for understanding the architecture of LISs. Chapter 7 addresses the regulatory requirements pertinent to LISs, and the basic concepts pertinent to ongoing maintenance of a system. Chapter 8 briefly discusses the building of reports in an LIS, a topic with more complexity than one might think. Chapter 9 addresses quality management. The introduction of the CLIA regulatory requirements over the two decades ago adds such complexity to quality management that computerization of the laboratory is all but required. Helpful examples are provided such as for cytology–histology correlation. The relation between reporting, quality management, and database architecture is not discussed, but admittedly such a discussion might have been beyond the scope of this work. The quality management chapter also provides a brief list of references which will be of interest to many readers. The other chapters lack such a reference list and although there is a short and well-chosen list of references at the end of the book, the reader who wishes to dig deeper into a particular area will need to search on their own. Fortunately, with online search tools, this will not be terribly difficult. Other chapters of general interest are devoted to telecytology, coding (CPT, ICD10, and SNOMED), barcoding, and digital imaging. Telecytology is of increasing relevance due to the increasing requests for rapid onsite evaluation for specimen adequacy of specimens procured by endoscopists, radiologists, or other clinicians. Telecytology allows such evaluations to be performed remotely, and thus utilizes the cytopathologists’ time more efficiently. Many cytologists will already have some familiarity with coding; however, barcoding is a “black box” to many, and the chapter on that topic shines a little light inside it. The chapter on digital imaging provides a good explanation of the basics principles of digital imaging including whole slide imaging as well as some direction on how to improve suboptimal images, but additional detail would have been helpful in this section and would not have been beyond the scope of the book. There are also chapters on project management, informatics projects, research informatics, bioinformatics, Lean Six Sigma, electronic medical records, automated cytology, and online cytology resources. At the end of the book, there is a listing of key definitions and recommended readings. In summary, practical informatics for cytopathology provides an introduction to informatics as applied to cytopathology. Cytologists who are not conversant with informatics will find it informative, and some will be inspired to delve deeper into the topic after reading this book.