The need for European professional standards and the challenges facing clinical microbiology.

PubMed

Humphreys, H; Nagy, E; Kahlmeter, G; Ruijs, G J H M

2010-06-01

Microorganisms spread across national boundaries and the professional activities of clinical (medical) microbiologists are critical in minimising their impact. Clinical microbiologists participate in many activities, e.g. diagnosis, antibiotic therapy, and there is a need for a set of professional standards for Europe with a common curriculum, to build upon the current strengths of the specialty and to facilitate the free movement of specialists within the European Union. Such standards will also better highlight the important contribution of clinical microbiologists to healthcare. There is a move to larger centralised microbiology laboratories often located off-site from an acute hospital, driven by the concentration of resources, amalgamation of services, outsourcing of diagnostics, automation, an explosion in the range of staff competencies and accreditation. Large off-site centralised microbiology laboratories are often distant to the patient and may not facilitate the early detection of microbial spread. Ultimately, the needs of patients and the public are paramount in deciding on the future direction of clinical microbiology. Potential conflicts between integration on an acute hospital site and centralisation can be resolved by a common set of professional standards and a team-based approach that puts patients first.

Defining the Path Forward: Guidance for Laboratory Medicine Guidelines

PubMed Central

Jones, Patricia M.; Chin, Alex C.; Christenson, Robert H.

2015-01-01

The National Academy of Clinical Biochemistry (NACB) has developed consensus-based guidelines for the laboratory evaluation and monitoring of patients with specified disorders for two decades. In 1997, the NACB recognized the need to standardize the process of guideline development and promulgated its first Standard Operating Procedure (SOP) for this purpose. In 2010, the American Association of Clinical Chemistry (AACC) and NACB created the Evidence-Based Laboratory Medicine Committee (EBLMC). Among other roles, this group was given responsibility to provide oversight of clinical practice guideline development in accordance with SOP guidance and using currently accepted good practices. In 2011, the U.S. Institute of Medicine (IOM) published two reports of relevance: ‘Clinical Practice Guidelines We Can Trust’ and ‘Finding What Works in Health Care – Standards for Systematic Reviews.’ These reports were created as part of a response to a legislative mandate from the U.S. Congress requesting that steps be taken to implement recommendations from lOM’s report on ‘Knowing What Works in Health Care’ (2008). The latest revision of the laboratory medicine practice guidelines (LMPG) SOP was in part driven by these reports. NACB continues to develop LMPGs at a rate of roughly one per year through standard processes detailed in its 2014 revision of the SOP. This article describes the NACB and EBLMC experience in developing LMPGs with a focus on the evolution and use of the latest SOP. AACC and NACB have established a solid track record in collaboratively working with many clinical societies and professional organizations on clinical practice guideline development. Presently, three LMPG’s are in various stages of development and all with the collaboration of other clinical/professional groups. The practices and tools being used for current LMPGs in progress are also highlighted in the context of the challenges that presently exist for effective clinical practice guideline development in the U.S. PMID:27683491

Using ATP-driven bioluminescence assay to monitor microbial safety in a contemporary human cadaver laboratory.

PubMed

Benninger, Brion; Maier, Thomas

2015-03-01

The objective of this study was to utilize a cost-effective method for assessing the levels of bacterial, yeast, and mold activity during a human dissection laboratory course. Nowadays, compliance with safety regulations is policed by institutions at higher standards than ever before. Fear of acquiring an unknown infection is one of the top concerns of professional healthcare students, and it provokes anti-laboratory anxiety. Human cadavers are not routinely tested for bacteria and viruses prior to embalming. Human anatomy dissecting rooms that house embalmed cadavers are normally cleaned after the dissected cadavers have been removed. There is no evidence that investigators have ever assessed bacterial and fungal activities using adenosine triphosphate (ATP)-driven bioluminescence assays. A literature search was conducted on texts, journals, and websites regarding bacterial, yeast, and mold activities in an active cadaver laboratory. Midway into a clinical anatomy course, ATP bioluminescence assays were used to swab various sites within the dissection room, including entrance and exiting door handles, water taps, cadaver tables, counter tops, imaging material, X-ray box switches, and the cadaver surfaces. The results demonstrated very low activities on cadaver tables, washing up areas, and exiting door handles. There was low activity on counter tops and X-ray boxes. There was medium activity on the entrance door handles. These findings suggest an inexpensive and accurate method for monitoring safety compliance and microbial activity. Students can feel confident and safe in the environment in which they work. © 2014 Wiley Periodicals, Inc.

Cost Effectiveness Analysis of Clinically Driven versus Routine Laboratory Monitoring of Antiretroviral Therapy in Uganda and Zimbabwe

PubMed Central

Medina Lara, Antonieta; Kigozi, Jesse; Amurwon, Jovita; Muchabaiwa, Lazarus; Nyanzi Wakaholi, Barbara; Mujica Mota, Ruben E.; Walker, A. Sarah; Kasirye, Ronnie; Ssali, Francis; Reid, Andrew; Grosskurth, Heiner; Babiker, Abdel G.; Kityo, Cissy; Katabira, Elly; Munderi, Paula; Mugyenyi, Peter; Hakim, James; Darbyshire, Janet; Gibb, Diana M.; Gilks, Charles F.

2012-01-01

Background Despite funding constraints for treatment programmes in Africa, the costs and economic consequences of routine laboratory monitoring for efficacy and toxicity of antiretroviral therapy (ART) have rarely been evaluated. Methods Cost-effectiveness analysis was conducted in the DART trial (ISRCTN13968779). Adults in Uganda/Zimbabwe starting ART were randomised to clinically-driven monitoring (CDM) or laboratory and clinical monitoring (LCM); individual patient data on healthcare resource utilisation and outcomes were valued with primary economic costs and utilities. Total costs of first/second-line ART, routine 12-weekly CD4 and biochemistry/haematology tests, additional diagnostic investigations, clinic visits, concomitant medications and hospitalisations were considered from the public healthcare sector perspective. A Markov model was used to extrapolate costs and benefits 20 years beyond the trial. Results 3316 (1660LCM;1656CDM) symptomatic, immunosuppressed ART-naive adults (median (IQR) age 37 (32,42); CD4 86 (31,139) cells/mm3) were followed for median 4.9 years. LCM had a mean 0.112 year (41 days) survival benefit at an additional mean cost of $765 [95%CI:685,845], translating into an adjusted incremental cost of $7386 [3277,dominated] per life-year gained and $7793 [4442,39179] per quality-adjusted life year gained. Routine toxicity tests were prominent cost-drivers and had no benefit. With 12-weekly CD4 monitoring from year 2 on ART, low-cost second-line ART, but without toxicity monitoring, CD4 test costs need to fall below $3.78 to become cost-effective (<3xper-capita GDP, following WHO benchmarks). CD4 monitoring at current costs as undertaken in DART was not cost-effective in the long-term. Conclusions There is no rationale for routine toxicity monitoring, which did not affect outcomes and was costly. Even though beneficial, there is little justification for routine 12-weekly CD4 monitoring of ART at current test costs in low-income African countries. CD4 monitoring, restricted to the second year on ART onwards, could be cost-effective with lower cost second-line therapy and development of a cheaper, ideally point-of-care, CD4 test. PMID:22545079

Influence of Test Section Geometry on the Blast Environment in an Explosively Driven Conical Shock Tube

DTIC Science & Technology

2018-03-30

ARL-TR-8335•MAR 2018 US Army Research Laboratory Influence of Test Section Geometry on theBlast Environment in an Explosively DrivenConical Shock...ARL-TR-8335•MAR 2018 US Army Research Laboratory Influence of Test Section Geometry on theBlast Environment in an Explosively DrivenConical Shock...Tube by Joel B Stewart Weapons and Materials Research Directorate, ARL Approved for public release; distribution is unlimited. REPORT DOCUMENTATION

An Hypothesis-Driven, Molecular Phylogenetics Exercise for College Biology Students

ERIC Educational Resources Information Center

Parker, Joel D.; Ziemba, Robert E.; Cahan, Sara Helms; Rissing, Steven W.

2004-01-01

This hypothesis-driven laboratory exercise teaches how DNA evidence can be used to investigate an organism's evolutionary history while providing practical modeling of the fundamental processes of gene transcription and translation. We used an inquiry-based approach to construct a laboratory around a nontrivial, open-ended evolutionary question…

Learning to Argue and Arguing to Learn: Argument-Driven Inquiry as a Way to Help Undergraduate Chemistry Students Learn How to Construct Arguments and Engage in Argumentation during a Laboratory Course

ERIC Educational Resources Information Center

Walker, Joi Phelps; Sampson, Victor

2013-01-01

This study examines whether students enrolled in a general chemistry I laboratory course developed the ability to participate in scientific argumentation over the course of a semester. The laboratory activities that the students participated in during the course were designed using the Argument-Driven Inquiry (ADI) an instructional model. This…

A laboratory facility for research on wind-driven rain intrusion in building envelope assemblies

Treesearch

Samuel V. Glass

2010-01-01

Moisture management is critical for durable, energy-efficient buildings. To address the need for research on wind-driven rain intrusion in wall assemblies, the U.S. Forest Products Laboratory is developing a new facility. This paper describes the underlying principle of this facility and its capabilities.

Problem-Based Learning and Creative Instructional Approaches for Laboratory Exercises in Introductory Crop Science

ERIC Educational Resources Information Center

Teplitski, Max; McMahon, Margaret J.

2006-01-01

The implementation of problem-based learning (PBL) and other inquiry-driven educational techniques is often resisted by both faculty and students, who may not be comfortable with this learning/instructional style. We present here a hybrid approach, which combines elements of expository education with inquiry-driven laboratory exercises and…

cp-R, an interface the R programming language for clinical laboratory method comparisons.

PubMed

Holmes, Daniel T

2015-02-01

Clinical scientists frequently need to compare two different bioanalytical methods as part of assay validation/monitoring. As a matter necessity, regression methods for quantitative comparison in clinical chemistry, hematology and other clinical laboratory disciplines must allow for error in both the x and y variables. Traditionally the methods popularized by 1) Deming and 2) Passing and Bablok have been recommended. While commercial tools exist, no simple open source tool is available. The purpose of this work was to develop and entirely open-source GUI-driven program for bioanalytical method comparisons capable of performing these regression methods and able to produce highly customized graphical output. The GUI is written in python and PyQt4 with R scripts performing regression and graphical functions. The program can be run from source code or as a pre-compiled binary executable. The software performs three forms of regression and offers weighting where applicable. Confidence bands of the regression are calculated using bootstrapping for Deming and Passing Bablok methods. Users can customize regression plots according to the tools available in R and can produced output in any of: jpg, png, tiff, bmp at any desired resolution or ps and pdf vector formats. Bland Altman plots and some regression diagnostic plots are also generated. Correctness of regression parameter estimates was confirmed against existing R packages. The program allows for rapid and highly customizable graphical output capable of conforming to the publication requirements of any clinical chemistry journal. Quick method comparisons can also be performed and cut and paste into spreadsheet or word processing applications. We present a simple and intuitive open source tool for quantitative method comparison in a clinical laboratory environment. Copyright © 2014 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Heparin-induced thrombocytopenia: reducing misdiagnosis via collaboration between an inpatient anticoagulation pharmacy service and hospital reference laboratory.

PubMed

Burnett, Allison E; Bowles, Harmony; Borrego, Matthew E; Montoya, Tiffany N; Garcia, David A; Mahan, Charles

2016-11-01

Misdiagnosis of heparin-induced thrombocytopenia (HIT) is common and exposes patients to high-risk therapies and potentially serious adverse events. The primary objective of this study was to evaluate the impact of collaboration between an inpatient pharmacy-driven anticoagulation management service (AMS) and hospital reference laboratory to reduce inappropriate HIT antibody testing via pharmacist intervention and use of the 4T pre-test probability score. Secondary objectives included clinical outcomes and cost-savings realized through reduced laboratory testing and decreased unnecessary treatment of HIT. This was a single center, pre-post, observational study. The hospital reference laboratory contacted the AMS when they received a blood sample for an enzyme-linked immunosorbent HIT antibody (HIT Ab). Trained pharmacists prospectively scored each HIT Ab ordered by using the 4T score with subsequent communication to physicians recommending for or against processing and reporting of lab results. Utilizing retrospective chart review and a database for all patients with a HIT Ab ordered during the study period, we compared the incidence of HIT Ab testing before and after implementation of the pharmacy-driven 4T score intervention. Our intervention significantly reduced the number of inappropriate HIT Ab tests processed (176 vs. 63, p < 0.0001), with no increase in thrombotic or hemorrhagic events. Overall incidence of suspected and confirmed HIT was <3 and <0.005 %, respectively. Overall cost savings were $75,754 (US) or 62 % per patient exposed to heparin between the pre and post intervention groups. Collaboration between inpatient pharmacy AMS and hospital reference laboratories can result in reduction of misdiagnosis of HIT and significant cost savings with similar safety.

Implementation of Argument-Driven Inquiry as an Instructional Model in a General Chemistry Laboratory Course

ERIC Educational Resources Information Center

Kadayifci, Hakki; Yalcin-Celik, Ayse

2016-01-01

This study examined the effectiveness of Argument-Driven Inquiry (ADI) as an instructional model in a general chemistry laboratory course. The study was conducted over the course of ten experimental sessions with 125 pre-service science teachers. The participants' level of reflective thinking about the ADI activities, changes in their science…

Future vaccination strategies against tuberculosis: thinking outside the box.

PubMed

Kaufmann, Stefan H E

2010-10-29

With almost a dozen vaccine candidates in clinical trials, tuberculosis (TB) research and development is finally reaping the first fruits of its labors. Vaccine candidates in clinical trials may prevent TB disease reactivation by efficiently containing the pathogen Mycobacterium tuberculosis (Mtb). Future research should target vaccines that achieve sterile eradication of Mtb or even prevent stable infection. These are ambitious goals that can be reached only by highly cooperative engagement of basic immunologists, vaccinologists, and clinical researchers--or in other words, by translation from basic immunology to vaccine research and development, as well as reverse translation of insights from clinical trials back to hypothesis-driven research in the basic laboratory. Here, we review current and future strategies toward the rational design of novel vaccines against TB, as well as the progress made thus far, and the hurdles that need to be overcome in the near and distant future. Copyright © 2010 Elsevier Inc. All rights reserved.

Teaching an engine-driven preparation technique to undergraduates: initial observations.

PubMed

Hänni, S; Schönenberger, K; Peters, O A; Barbakow, F

2003-07-01

This paper describes the initial experiences following the introduction of a rotary engine-driven preparation technique into the undergraduate endodontic programme at the Zurich University Dental Centre. Forty third-year students practised the ProFile.04 (PF.04) technique between January and July 2001 in a preclinical course. Between November 2001 and February 2002, 20 of these students (Group A) root-treated 51 teeth in their clinical course using either PF.04, the balanced force technique (BFT) or a combination of both. The second group of 20 students (Group B) similarly treated another 36 randomly selected teeth between April and July 2002. Types of teeth treated by the students and the canal preparation techniques were recorded. The students also completed a short questionnaire, evaluating their opinions of the new course. Of the 87 teeth endodontically treated during the clinical course, 34, 14 and 39 were shaped using PF.04 alone, a combination of PF.04 and BFT and BFT alone, respectively. No rotary instruments were fractured during the 1-year clinical course, although some instruments were fractured during the preclinical laboratory course. Overall, the students rated the rotary technique as positive. A rotary technique was successfully introduced into an undergraduate endodontic programme (this will be continued in the foreseeable future). However, the continuity between the preclinical and the clinical courses was poor as a result of the constraints of the general teaching programme.

Mobile Devices for the Remote Acquisition of Physiological and Behavioral Biomarkers in Psychiatric Clinical Research

PubMed Central

Adams, Zachary; McClure, Erin A.; Gray, Kevin M.; Danielson, Carla Kmett; Treiber, Frank A.; Ruggiero, Kenneth J.

2016-01-01

Psychiatric disorders are linked to a variety of biological, psychological, and contextual causes and consequences. Laboratory studies have elucidated the importance of several key physiological and behavioral biomarkers in the study of psychiatric disorders, but much less is known about the role of these biomarkers in naturalistic settings. These gaps are largely driven by methodological barriers to assessing biomarker data rapidly, reliably, and frequently outside the clinic or laboratory. Mobile health (mHealth) tools offer new opportunities to study relevant biomarkers in concert with other types of data (e.g., self-reports, global positioning system data). This review provides an overview on the state of this emerging field and describes examples from the literature where mHealth tools have been used to measure a wide array of biomarkers in the context of psychiatric functioning (e.g., psychological stress, anxiety, autism, substance use). We also outline advantages and special considerations for incorporating mHealth tools for remote biomarker measurement into studies of psychiatric illness and treatment and identify several specific opportunities for expanding this promising methodology. Integrating mHealth tools into this area may dramatically improve psychiatric science and facilitate highly personalized clinical care of psychiatric disorders. PMID:27814455

The new collaborative path in medical device development: the medical device innovation consortium.

PubMed

Kampfrath, Thomas; Cotten, Steven W

2013-10-01

The United States medical device market is the world's largest with over $100 billion in sales in 2011. Despite robust industry growth, the efficiency of the FDA approval process for moderate-risk (Class II) and high-risk devices (Class III) requiring 510(k) submission or pre-market approval (PMA) has been criticized. Recently, the FDA's Center for Devices and Radiological Health (CDRH) announced the creation of a Medical Device Innovation Consortium (MDIC), a public-private partnership (PPP) to share knowledge in regulatory science. Overarching goals include creating a forum for the exchange of ideas among the FDA, industry, and non-profit entities; providing monetary investments for project proposals prioritized by key working groups; and developing tools that support cost effective innovation, data-driven methodology, and implementation strategies. Clinical chemists and clinical laboratory scientists have several unique opportunities to contribute to the MDIC. These laboratory professionals have invaluable experience with the real-life performance of a variety of medical devices and their expertise can recognize unmet needs and contribute towards the acceleration of device development. Copyright © 2013 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Developing High School Students' Self-Efficacy and Perceptions about Inquiry and Laboratory Skills through Argument-Driven Inquiry

ERIC Educational Resources Information Center

Eymur, Guluzar

2018-01-01

The present study investigated how students' self-efficacy changed after participation in four lab investigations that were designed on the basis of a new laboratory instructional strategy, namely, argument-driven inquiry (ADI). The study was conducted with 64 10th grade students from two intact classes in a public high school in the northeast of…

BOW SHOCK FRAGMENTATION DRIVEN BY A THERMAL INSTABILITY IN LABORATORY ASTROPHYSICS EXPERIMENTS

DOE Office of Scientific and Technical Information (OSTI.GOV)

Suzuki-Vidal, F.; Lebedev, S. V.; Pickworth, L. A.

The role of radiative cooling during the evolution of a bow shock was studied in laboratory-astrophysics experiments that are scalable to bow shocks present in jets from young stellar objects. The laboratory bow shock is formed during the collision of two counterstreaming, supersonic plasma jets produced by an opposing pair of radial foil Z-pinches driven by the current pulse from the MAGPIE pulsed-power generator. The jets have different flow velocities in the laboratory frame, and the experiments are driven over many times the characteristic cooling timescale. The initially smooth bow shock rapidly develops small-scale nonuniformities over temporal and spatial scalesmore » that are consistent with a thermal instability triggered by strong radiative cooling in the shock. The growth of these perturbations eventually results in a global fragmentation of the bow shock front. The formation of a thermal instability is supported by analysis of the plasma cooling function calculated for the experimental conditions with the radiative packages ABAKO/RAPCAL.« less

Application of the Toyota Production System improves core laboratory operations.

PubMed

Rutledge, Joe; Xu, Min; Simpson, Joanne

2010-01-01

To meet the increased clinical demands of our hospital expansion, improve quality, and reduce costs, our tertiary care, pediatric core laboratory used the Toyota Production System lean processing to reorganize our 24-hour, 7 d/wk core laboratory. A 4-month, consultant-driven process removed waste, led to a physical reset of the space to match the work flow, and developed a work cell for our random access analyzers. In addition, visual controls, single piece flow, standard work, and "5S" were instituted. The new design met our goals as reflected by achieving and maintaining improved turnaround time (TAT; mean for creatinine reduced from 54 to 23 minutes) with increased testing volume (20%), monetary savings (4 full-time equivalents), decreased variability in TAT, and better space utilization (25% gain). The project had the unanticipated consequence of eliminating STAT testing because our in-laboratory TAT for routine testing was less than our prior STAT turnaround goal. The viability of this approach is demonstrated by sustained gains and further PDCA (Plan, Do, Check, Act) improvements during the 4 years after completion of the project.

A data-driven algorithm integrating clinical and laboratory features for the diagnosis and prognosis of necrotizing enterocolitis.

PubMed

Ji, Jun; Ling, Xuefeng B; Zhao, Yingzhen; Hu, Zhongkai; Zheng, Xiaolin; Xu, Zhening; Wen, Qiaojun; Kastenberg, Zachary J; Li, Ping; Abdullah, Fizan; Brandt, Mary L; Ehrenkranz, Richard A; Harris, Mary Catherine; Lee, Timothy C; Simpson, B Joyce; Bowers, Corinna; Moss, R Lawrence; Sylvester, Karl G

2014-01-01

Necrotizing enterocolitis (NEC) is a major source of neonatal morbidity and mortality. Since there is no specific diagnostic test or risk of progression model available for NEC, the diagnosis and outcome prediction of NEC is made on clinical grounds. The objective in this study was to develop and validate new NEC scoring systems for automated staging and prognostic forecasting. A six-center consortium of university based pediatric teaching hospitals prospectively collected data on infants under suspicion of having NEC over a 7-year period. A database comprised of 520 infants was utilized to develop the NEC diagnostic and prognostic models by dividing the entire dataset into training and testing cohorts of demographically matched subjects. Developed on the training cohort and validated on the blind testing cohort, our multivariate analyses led to NEC scoring metrics integrating clinical data. Machine learning using clinical and laboratory results at the time of clinical presentation led to two nec models: (1) an automated diagnostic classification scheme; (2) a dynamic prognostic method for risk-stratifying patients into low, intermediate and high NEC scores to determine the risk for disease progression. We submit that dynamic risk stratification of infants with NEC will assist clinicians in determining the need for additional diagnostic testing and guide potential therapies in a dynamic manner. http://translationalmedicine.stanford.edu/cgi-bin/NEC/index.pl and smartphone application upon request.

Wind driven erosion and the effects of particulate electrification

NASA Astrophysics Data System (ADS)

Merrison, J. P.; Bak, E.; Finster, K.; Gunnlaugsson, H. P.; Holstein-Rathlou, C.; Knak Jensen, S.; Nørnberg, P.; Rasmussen, K. R.

2012-09-01

Several related aspects of Aeolian activity are presently being studied in the laboratory, the most recent advances in this field will be presented. These include simulating wind driven erosion in the laboratory, quantifying erosion rates and the study of mineral change due to mechanical activation. Also advances in our understanding of the electrification of sand/dust particles is being made and how this phenomenon affects their behavior.

Opportunities for improving the efficiency of paediatric HIV treatment programmes

PubMed Central

Revill, Paul A.; Walker, Simon; Mabugu, Travor; Nathoo, Kusum J.; Mugyenyi, Peter; Kekitinwa, Adeodata; Munderi, Paula; Bwakura-Dangarembizi, Mutsawashe; Musiime, Victor; Bakeera-Kitaka, Sabrina; Nahirya-Ntege, Patricia; Walker, A. Sarah; Sculpher, Mark J.; Gibb, Diana M.

2015-01-01

Objectives: To conduct two economic analyses addressing whether to: routinely monitor HIV-infected children on antiretroviral therapy (ART) clinically or with laboratory tests; continue or stop cotrimoxazole prophylaxis when children become stabilized on ART. Design and methods: The ARROW randomized trial investigated alternative strategies to deliver paediatric ART and cotrimoxazole prophylaxis in 1206 Ugandan/Zimbabwean children. Incremental cost-effectiveness and value of implementation analyses were undertaken. Scenario analyses investigated whether laboratory monitoring (CD4+ tests for efficacy monitoring; haematology/biochemistry for toxicity) could be tailored and targeted to be delivered cost-effectively. Cotrimoxazole use was examined in malaria-endemic and non-endemic settings. Results: Using all trial data, clinical monitoring delivered similar health outcomes to routine laboratory monitoring, but at a reduced cost, so was cost-effective. Continuing cotrimoxazole improved health outcomes at reduced costs. Restricting routine CD4+ monitoring to after 52 weeks following ART initiation and removing toxicity testing was associated with an incremental cost-effectiveness ratio of $6084 per quality-adjusted life-year (QALY) across all age groups, but was much lower for older children (12+ years at initiation; incremental cost-effectiveness ratio = $769/QALY). Committing resources to improve cotrimoxazole implementation appears cost-effective. A healthcare system that could pay $600/QALY should be willing to spend up to $12.0 per patient-year to ensure continued provision of cotrimoxazole. Conclusion: Clinically driven monitoring of ART is cost-effective in most circumstances. Routine laboratory monitoring is generally not cost-effective at current prices, except possibly CD4+ testing amongst adolescents initiating ART. Committing resources to ensure continued provision of cotrimoxazole in health facilities is more likely to represent an efficient use of resources. PMID:25396263

Dentin Biomodification: Strategies, Renewable Resources and Clinical Applications

PubMed Central

Bedran-Russo, Ana K.; Pauli, Guido F.; Chen, Shao-Nong; McAlpine, James; Castellan, Carina S.; Phansalkar, Rasika S; Aguiar, Thaiane R.; Vidal, Cristina M.P.; Napotilano, José; Nam, Joo-Won; Leme, Ariene A.

2014-01-01

Objectives The biomodification of dentin is a biomimetic approach, mediated by bioactive agents, to enhance and reinforce the dentin by locally altering the biochemistry and biomechanical properties. This review provides an overview of key dentin matrix components, targeting effects of biomodification strategies, the chemistry of renewable natural sources, and current research on their potential clinical applications. Methods The PubMed database and collected literature were used as a resource for peer-reviewed articles to highlight the topics of dentin hierarchical structure, biomodification agents, and laboratorial investigations of their clinical applications. In addition, new data is presented on laboratorial methods for the standardization of proanthocyanidin-rich preparations as a renewable source of plant-derived biomodification agents. Results Biomodification agents can be categorized as physical methods and chemical agents. Synthetic and naturally occurring chemical strategies present distinctive mechanism of interaction with the tissue. Initially thought to be driven only by inter- or intra-molecular collagen induced non-enzymatic collagen cross-linking, multiple interactions with other dentin components are fundamental for the long-term biomechanics and biostability of the tissue. Oligomeric proanthocyanidins show promising bioactivity, and their chemical complexity requires systematic evaluation of the active compounds to produce a fully standardized intervention material from renewable resource, prior to their detailed clinical evaluation. Significance Understanding the hierarchical structure of dentin and the targeting effect of the bioactive compounds will establish their use in both dentin-biomaterials interface and caries management. PMID:24309436

Evidence based vaccinology.

PubMed

Nalin, David R

2002-02-22

Evidence based vaccinology (EBV) is the identification and use of the best evidence in making and implementing decisions during all of the stages of the life of a vaccine, including pre-licensure vaccine development and post-licensure manufacture and research, and utilization of the vaccine for disease control. Vaccines, unlike most pharmaceuticals, are in a continuous process of development both before and after licensure. Changes in biologics manufacturing technology and changes that vaccines induce in population and disease biology lead to periodic review of regimens (and sometimes dosage) based on changing immunologic data or public perceptions relevant to vaccine safety and effectiveness. EBV includes the use of evidence based medicine (EBM) both in clinical trials and in national disease containment programs. The rationale for EBV is that the highest evidentiary standards are required to maintain a rigorous scientific basis of vaccine quality control in manufacture and to ensure valid determination of vaccine efficacy, field effectiveness and safety profiles (including post-licensure safety monitoring), cost-benefit analyses, and risk:benefit ratios. EBV is increasingly based on statistically validated, clearly defined laboratory, manufacturing, clinical and epidemiological research methods and procedures, codified as good laboratory practices (GLP), good manufacturing practices (GMP), good clinical research practices (GCRP) and in clinical and public health practice (good vaccination practices, GVP). Implementation demands many data-driven decisions made by a spectrum of specialists pre- and post-licensure, and is essential to maintaining public confidence in vaccines.

Can Unmanned Aerial Systems (Drones) Be Used for the Routine Transport of Chemistry, Hematology, and Coagulation Laboratory Specimens?

PubMed

Amukele, Timothy K; Sokoll, Lori J; Pepper, Daniel; Howard, Dana P; Street, Jeff

2015-01-01

Unmanned Aerial Systems (UAS or drones) could potentially be used for the routine transport of small goods such as diagnostic clinical laboratory specimens. To the best of our knowledge, there is no published study of the impact of UAS transportation on laboratory tests. Three paired samples were obtained from each one of 56 adult volunteers in a single phlebotomy event (336 samples total): two tubes each for chemistry, hematology, and coagulation testing respectively. 168 samples were driven to the flight field and held stationary. The other 168 samples were flown in the UAS for a range of times, from 6 to 38 minutes. After the flight, 33 of the most common chemistry, hematology, and coagulation tests were performed. Statistical methods as well as performance criteria from four distinct clinical, academic, and regulatory bodies were used to evaluate the results. Results from flown and stationary sample pairs were similar for all 33 analytes. Bias and intercepts were <10% and <13% respectively for all analytes. Bland-Altman comparisons showed a mean difference of 3.2% for Glucose and <1% for other analytes. Only bicarbonate did not meet the strictest (Royal College of Pathologists of Australasia Quality Assurance Program) performance criteria. This was due to poor precision rather than bias. There were no systematic differences between laboratory-derived (analytic) CV's and the CV's of our flown versus terrestrial sample pairs however CV's from the sample pairs tended to be slightly higher than analytic CV's. The overall concordance, based on clinical stratification (normal versus abnormal), was 97%. Length of flight had no impact on the results. Transportation of laboratory specimens via small UASs does not affect the accuracy of routine chemistry, hematology, and coagulation tests results from selfsame samples. However it results in slightly poorer precision for some analytes.

Hypothesis-Driven Laboratories: An Innovative Way to Foster Learning in Physiology Laboratory Courses

ERIC Educational Resources Information Center

Steury, Michael D.; Poteracki, James M.; Kelly, Kevin L.; Rennhack, Jonathan; Wehrwein, Erica A.

2016-01-01

Physiology instructors often are faced with the challenge of providing informative and educationally stimulating laboratories while trying to design them in such a way that encourages students to be actively involved in their own learning. With many laboratory experiments designed with simplicity and efficiency as the primary focus, it is…

Mobile devices for the remote acquisition of physiological and behavioral biomarkers in psychiatric clinical research.

PubMed

W Adams, Zachary; McClure, Erin A; Gray, Kevin M; Danielson, Carla Kmett; Treiber, Frank A; Ruggiero, Kenneth J

2017-02-01

Psychiatric disorders are linked to a variety of biological, psychological, and contextual causes and consequences. Laboratory studies have elucidated the importance of several key physiological and behavioral biomarkers in the study of psychiatric disorders, but much less is known about the role of these biomarkers in naturalistic settings. These gaps are largely driven by methodological barriers to assessing biomarker data rapidly, reliably, and frequently outside the clinic or laboratory. Mobile health (mHealth) tools offer new opportunities to study relevant biomarkers in concert with other types of data (e.g., self-reports, global positioning system data). This review provides an overview on the state of this emerging field and describes examples from the literature where mHealth tools have been used to measure a wide array of biomarkers in the context of psychiatric functioning (e.g., psychological stress, anxiety, autism, substance use). We also outline advantages and special considerations for incorporating mHealth tools for remote biomarker measurement into studies of psychiatric illness and treatment and identify several specific opportunities for expanding this promising methodology. Integrating mHealth tools into this area may dramatically improve psychiatric science and facilitate highly personalized clinical care of psychiatric disorders. Copyright © 2016 Elsevier Ltd. All rights reserved.

A Multi-mission Event-Driven Component-Based System for Support of Flight Software Development, ATLO, and Operations first used by the Mars Science Laboratory (MSL) Project

NASA Technical Reports Server (NTRS)

Dehghani, Navid; Tankenson, Michael

2006-01-01

This paper details an architectural description of the Mission Data Processing and Control System (MPCS), an event-driven, multi-mission ground data processing components providing uplink, downlink, and data management capabilities which will support the Mars Science Laboratory (MSL) project as its first target mission. MPCS is developed based on a set of small reusable components, implemented in Java, each designed with a specific function and well-defined interfaces. An industry standard messaging bus is used to transfer information among system components. Components generate standard messages which are used to capture system information, as well as triggers to support the event-driven architecture of the system. Event-driven systems are highly desirable for processing high-rate telemetry (science and engineering) data, and for supporting automation for many mission operations processes.

Using a Time-Driven Activity-Based Costing Model To Determine the Actual Cost of Services Provided by a Transgenic Core.

PubMed

Gerwin, Philip M; Norinsky, Rada M; Tolwani, Ravi J

2018-03-01

Laboratory animal programs and core laboratories often set service rates based on cost estimates. However, actual costs may be unknown, and service rates may not reflect the actual cost of services. Accurately evaluating the actual costs of services can be challenging and time-consuming. We used a time-driven activity-based costing (ABC) model to determine the cost of services provided by a resource laboratory at our institution. The time-driven approach is a more efficient approach to calculating costs than using a traditional ABC model. We calculated only 2 parameters: the time required to perform an activity and the unit cost of the activity based on employee cost. This method allowed us to rapidly and accurately calculate the actual cost of services provided, including microinjection of a DNA construct, microinjection of embryonic stem cells, embryo transfer, and in vitro fertilization. We successfully implemented a time-driven ABC model to evaluate the cost of these services and the capacity of labor used to deliver them. We determined how actual costs compared with current service rates. In addition, we determined that the labor supplied to conduct all services (10,645 min/wk) exceeded the practical labor capacity (8400 min/wk), indicating that the laboratory team was highly efficient and that additional labor capacity was needed to prevent overloading of the current team. Importantly, this time-driven ABC approach allowed us to establish a baseline model that can easily be updated to reflect operational changes or changes in labor costs. We demonstrated that a time-driven ABC model is a powerful management tool that can be applied to other core facilities as well as to entire animal programs, providing valuable information that can be used to set rates based on the actual cost of services and to improve operating efficiency.

On the generation of magnetized collisionless shocks in the large plasma device

NASA Astrophysics Data System (ADS)

Schaeffer, D. B.; Winske, D.; Larson, D. J.; Cowee, M. M.; Constantin, C. G.; Bondarenko, A. S.; Clark, S. E.; Niemann, C.

2017-04-01

Collisionless shocks are common phenomena in space and astrophysical systems, and in many cases, the shocks can be modeled as the result of the expansion of a magnetic piston though a magnetized ambient plasma. Only recently, however, have laser facilities and diagnostic capabilities evolved sufficiently to allow the detailed study in the laboratory of the microphysics of piston-driven shocks. We review experiments on collisionless shocks driven by a laser-produced magnetic piston undertaken with the Phoenix laser laboratory and the Large Plasma Device at the University of California, Los Angeles. The experiments span a large parameter space in laser energy, background magnetic field, and ambient plasma properties that allow us to probe the physics of piston-ambient energy coupling, the launching of magnetosonic solitons, and the formation of subcritical shocks. The results indicate that piston-driven magnetized collisionless shocks in the laboratory can be characterized with a small set of dimensionless formation parameters that place the formation process in an organized and predictive framework.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Schaeffer, D. B.; Winske, D.; Larson, D. J.

Collisionless shocks are common phenomena in space and astrophysical systems, and in many cases, the shocks can be modeled as the result of the expansion of a magnetic piston though a magnetized ambient plasma. Only recently, however, have laser facilities and diagnostic capabilities evolved sufficiently to allow the detailed study in the laboratory of the microphysics of piston-driven shocks. We review experiments on collisionless shocks driven by a laser-produced magnetic piston undertaken with the Phoenix laser laboratory and the Large Plasma Device at the University of California, Los Angeles. The experiments span a large parameter space in laser energy, backgroundmore » magnetic field, and ambient plasma properties that allow us to probe the physics of piston-ambient energy coupling, the launching of magnetosonic solitons, and the formation of subcritical shocks. Here, the results indicate that piston-driven magnetized collisionless shocks in the laboratory can be characterized with a small set of dimensionless formation parameters that place the formation process in an organized and predictive framework.« less

On the generation of magnetized collisionless shocks in the large plasma device

DOE PAGES

Schaeffer, D. B.; Winske, D.; Larson, D. J.; ...

2017-03-22

Collisionless shocks are common phenomena in space and astrophysical systems, and in many cases, the shocks can be modeled as the result of the expansion of a magnetic piston though a magnetized ambient plasma. Only recently, however, have laser facilities and diagnostic capabilities evolved sufficiently to allow the detailed study in the laboratory of the microphysics of piston-driven shocks. We review experiments on collisionless shocks driven by a laser-produced magnetic piston undertaken with the Phoenix laser laboratory and the Large Plasma Device at the University of California, Los Angeles. The experiments span a large parameter space in laser energy, backgroundmore » magnetic field, and ambient plasma properties that allow us to probe the physics of piston-ambient energy coupling, the launching of magnetosonic solitons, and the formation of subcritical shocks. Here, the results indicate that piston-driven magnetized collisionless shocks in the laboratory can be characterized with a small set of dimensionless formation parameters that place the formation process in an organized and predictive framework.« less

Neuroscience-driven discovery and development of sleep therapeutics.

PubMed

Dresler, M; Spoormaker, V I; Beitinger, P; Czisch, M; Kimura, M; Steiger, A; Holsboer, F

2014-03-01

Until recently, neuroscience has given sleep research and discovery of better treatments of sleep disturbances little attention, despite the fact that disturbed sleep has overwhelming impact on human health. Sleep is a complex phenomenon in which specific psychological, electrophysiological, neurochemical, endocrinological, immunological and genetic factors are involved. The brain as both the generator and main object of sleep is obviously of particular interest, which makes a neuroscience-driven view the most promising approach to evaluate clinical implications and applications of sleep research. Polysomnography as the gold standard of sleep research, complemented by brain imaging, neuroendocrine testing, genomics and other laboratory measures can help to create composite biomarkers that allow maximizing the effects of individualized therapies while minimizing adverse effects. Here we review the current state of the neuroscience of sleep, sleep disorders and sleep therapeutics and will give some leads to promote the discovery and development of sleep medicines that are better than those we have today. Copyright © 2013 Elsevier Inc. All rights reserved.

Do you kiss your mother with that mouth? An authentic large-scale undergraduate research experience in mapping the human oral microbiome.

PubMed

Wang, Jack T H; Daly, Joshua N; Willner, Dana L; Patil, Jayee; Hall, Roy A; Schembri, Mark A; Tyson, Gene W; Hugenholtz, Philip

2015-05-01

Clinical microbiology testing is crucial for the diagnosis and treatment of community and hospital-acquired infections. Laboratory scientists need to utilize technical and problem-solving skills to select from a wide array of microbial identification techniques. The inquiry-driven laboratory training required to prepare microbiology graduates for this professional environment can be difficult to replicate within undergraduate curricula, especially in courses that accommodate large student cohorts. We aimed to improve undergraduate scientific training by engaging hundreds of introductory microbiology students in an Authentic Large-Scale Undergraduate Research Experience (ALURE). The ALURE aimed to characterize the microorganisms that reside in the healthy human oral cavity-the oral microbiome-by analyzing hundreds of samples obtained from student volunteers within the course. Students were able to choose from selective and differential culture media, Gram-staining, microscopy, as well as polymerase chain reaction (PCR) and 16S rRNA gene sequencing techniques, in order to collect, analyze, and interpret novel data to determine the collective oral microbiome of the student cohort. Pre- and postsurvey analysis of student learning gains across two iterations of the course (2012-2013) revealed significantly higher student confidence in laboratory skills following the completion of the ALURE (p < 0.05 using the Mann-Whitney U-test). Learning objectives on effective scientific communication were also met through effective student performance in laboratory reports describing the research outcomes of the project. The integration of undergraduate research in clinical microbiology has the capacity to deliver authentic research experiences and improve scientific training for large cohorts of undergraduate students.

[Blood-sugar self control. A means for the diabetic of controlling his metabolic management. Quality control of a battery-run pocket size reflectometer (glucose-meter)].

PubMed

Leidinger, F; Jörgens, V; Chantelau, E; Berchtold, P; Berger, M

1980-07-26

Home blood glucose monitoring by diabetic patients has recently been advocated as an effective means to improve metabolic control. The Glucocheck apparatus, a pocket-size battery-driven reflectance-meter (in Germany commercially available under the name Glucose-meter), has been evaluated for accuracy and practicability. In 450 blood glucose measurements, the variance between the values obtained using the Glucocheck apparatus and routine clinical laboratory procedures was +/- 11.7%. Especially in the low range of blood glucose concentrations, the Glucocheck method was very reliable. The quantitative precision of the Glucocheck method depends, however, quite considerably on the ability of the patient to use the apparatus correctly. In order to profit from Glucocheck in clinical practice, particular efforts to educate the patients in its use are necessary.

Considerations for Explosively Driven Conical Shock Tube Design: Computations and Experiments

DTIC Science & Technology

2017-02-16

ARL-TR-7953 ● FEB 2017 US Army Research Laboratory Considerations for Explosively Driven Conical Shock Tube Design : Computations...The findings in this report are not to be construed as an official Department of the Army position unless so designated by other authorized...Considerations for Explosively Driven Conical Shock Tube Designs : Computations and Experiments by Joel B Stewart Weapons and Materials Research Directorate

Views of Translational Research from a Somewhat Translational Scientist

PubMed Central

Talman, William T.

2013-01-01

This review arose from a talk entitled “Identifying Targets” and given by the author at EB2011 at the invitation of the American Federation for Medical Research (AFMR). The presentation was part of the AFMR workshop entitled “Keys for Translation: Science and Strategy” and focused on identifying clinically relevant targets as a result of observations made during basic scientific studies. The review emphasizes that targets do not have to be the aim that drives basic discovery, but communication between the basic scientist and clinical investigators may aid recognition of such targets and their translation to clinical applications. Using one line of investigator-initiated research from his own laboratory as an example, the author emphasizes that basic discovery must be hypothesis driven and allowed to follow its logical sequence. Finding treatments, while always an aim of biomedical research, may arise as a result of basic studies that were not originally aimed at a target of translational research. PMID:22781556

Platelet Aggregometry Testing: Molecular Mechanisms, Techniques and Clinical Implications

PubMed Central

Koltai, Katalin; Kesmarky, Gabor; Feher, Gergely; Tibold, Antal

2017-01-01

Platelets play a fundamental role in normal hemostasis, while their inherited or acquired dysfunctions are involved in a variety of bleeding disorders or thrombotic events. Several laboratory methodologies or point-of-care testing methods are currently available for clinical and experimental settings. These methods describe different aspects of platelet function based on platelet aggregation, platelet adhesion, the viscoelastic properties during clot formation, the evaluation of thromboxane metabolism or certain flow cytometry techniques. Platelet aggregometry is applied in different clinical settings as monitoring response to antiplatelet therapies, the assessment of perioperative bleeding risk, the diagnosis of inherited bleeding disorders or in transfusion medicine. The rationale for platelet function-driven antiplatelet therapy was based on the result of several studies on patients undergoing percutaneous coronary intervention (PCI), where an association between high platelet reactivity despite P2Y12 inhibition and ischemic events as stent thrombosis or cardiovascular death was found. However, recent large scale randomized, controlled trials have consistently failed to demonstrate a benefit of personalised antiplatelet therapy based on platelet function testing. PMID:28820484

Evaluation of locally established reference intervals for hematology and biochemistry parameters in Western Kenya.

PubMed

Odhiambo, Collins; Oyaro, Boaz; Odipo, Richard; Otieno, Fredrick; Alemnji, George; Williamson, John; Zeh, Clement

2015-01-01

Important differences have been demonstrated in laboratory parameters from healthy persons in different geographical regions and populations, mostly driven by a combination of genetic, demographic, nutritional, and environmental factors. Despite this, European and North American derived laboratory reference intervals are used in African countries for patient management, clinical trial eligibility, and toxicity determination; which can result in misclassification of healthy persons as having laboratory abnormalities. An observational prospective cohort study known as the Kisumu Incidence Cohort Study (KICoS) was conducted to estimate the incidence of HIV seroconversion and identify determinants of successful recruitment and retention in preparation for an HIV vaccine/prevention trial among young adults and adolescents in western Kenya. Laboratory values generated from the KICoS were compared to published region-specific reference intervals and the 2004 NIH DAIDS toxicity tables used for the trial. About 1106 participants were screened for the KICoS between January 2007 and June 2010. Nine hundred and fifty-three participants aged 16 to 34 years, HIV-seronegative, clinically healthy, and non-pregnant were selected for this analysis. Median and 95% reference intervals were calculated for hematological and biochemistry parameters. When compared with both published region-specific reference values and the 2004 NIH DAIDS toxicity table, it was shown that the use of locally established reference intervals would have resulted in fewer participants classified as having abnormal hematological or biochemistry values compared to US derived reference intervals from DAIDS (10% classified as abnormal by local parameters vs. >40% by US DAIDS). Blood urea nitrogen was most often out of range if US based intervals were used: <10% abnormal by local intervals compared to >83% by US based reference intervals. Differences in reference intervals for hematological and biochemical parameters between western and African populations highlight importance of developing local reference intervals for clinical care and trials in Africa.

Modeling Laser-Driven Laboratory Astrophysics Experiments Using the CRASH Code

NASA Astrophysics Data System (ADS)

Grosskopf, Michael; Keiter, P.; Kuranz, C. C.; Malamud, G.; Trantham, M.; Drake, R.

2013-06-01

Laser-driven, laboratory astrophysics experiments can provide important insight into the physical processes relevant to astrophysical systems. The radiation hydrodynamics code developed by the Center for Radiative Shock Hydrodynamics (CRASH) at the University of Michigan has been used to model experimental designs for high-energy-density laboratory astrophysics campaigns on OMEGA and other high-energy laser facilities. This code is an Eulerian, block-adaptive AMR hydrodynamics code with implicit multigroup radiation transport and electron heat conduction. The CRASH model has been used on many applications including: radiative shocks, Kelvin-Helmholtz and Rayleigh-Taylor experiments on the OMEGA laser; as well as laser-driven ablative plumes in experiments by the Astrophysical Collisionless Shocks Experiments with Lasers (ACSEL) collaboration. We report a series of results with the CRASH code in support of design work for upcoming high-energy-density physics experiments, as well as comparison between existing experimental data and simulation results. This work is funded by the Predictive Sciences Academic Alliances Program in NNSA-ASC via grant DEFC52- 08NA28616, by the NNSA-DS and SC-OFES Joint Program in High-Energy-Density Laboratory Plasmas, grant number DE-FG52-09NA29548, and by the National Laser User Facility Program, grant number DE-NA0000850.

Design and Construction of a Shock Tube Experiment for Multiphase Instability Experiments

NASA Astrophysics Data System (ADS)

Middlebrooks, John; Black, Wolfgang; Avgoustopoulos, Constantine; Allen, Roy; Kathakapa, Raj; Guo, Qiwen; McFarland, Jacob

2016-11-01

Hydrodynamic instabilities are important phenomena that have a wide range of practical applications in engineering and physics. One such instability, the shock driven multiphase instability (SDMI), arises when a shockwave accelerates an interface between two particle-gas mixtures with differing multiphase properties. The SDMI is present in high energy explosives, scramjets, and supernovae. A practical way of studying shock wave driven instabilities is through experimentation in a shock tube laboratory. This poster presentation will cover the design and data acquisition process of the University of Missouri's Fluid Mixing Shock Tube Laboratory. In the shock tube, a pressure generated shockwave is passed through a multiphase interface, creating the SDMI instability. This can be photographed for observation using high speed cameras, lasers, and advance imaging techniques. Important experimental parameters such as internal pressure and temperature, and mass flow rates of gases can be set and recorded by remotely controlled devices. The experimental facility provides the University of Missouri's Fluid Mixing Shock Tube Laboratory with the ability to validate simulated experiments and to conduct further inquiry into the field of shock driven multiphase hydrodynamic instabilities. Advisor.

Argument-Driven Inquiry

ERIC Educational Resources Information Center

Sampson, Victor; Grooms, Jonathon; Walker, Joi

2009-01-01

Argument-Driven Inquiry (ADI) is an instructional model that enables science teachers to transform a traditional laboratory activity into a short integrated instructional unit. To illustrate how the ADI instructional model works, this article describes an ADI lesson developed for a 10th-grade chemistry class. This example lesson was designed to…

Cardiac catheterization laboratory inpatient forecast tool: a prospective evaluation

PubMed Central

Flanagan, Eleni; Siddiqui, Sauleh; Appelbaum, Jeff; Kasper, Edward K; Levin, Scott

2016-01-01

Objective To develop and prospectively evaluate a web-based tool that forecasts the daily bed need for admissions from the cardiac catheterization laboratory using routinely available clinical data within electronic medical records (EMRs). Methods The forecast model was derived using a 13-month retrospective cohort of 6384 catheterization patients. Predictor variables such as demographics, scheduled procedures, and clinical indicators mined from free-text notes were input to a multivariable logistic regression model that predicted the probability of inpatient admission. The model was embedded into a web-based application connected to the local EMR system and used to support bed management decisions. After implementation, the tool was prospectively evaluated for accuracy on a 13-month test cohort of 7029 catheterization patients. Results The forecast model predicted admission with an area under the receiver operating characteristic curve of 0.722. Daily aggregate forecasts were accurate to within one bed for 70.3% of days and within three beds for 97.5% of days during the prospective evaluation period. The web-based application housing the forecast model was used by cardiology providers in practice to estimate daily admissions from the catheterization laboratory. Discussion The forecast model identified older age, male gender, invasive procedures, coronary artery bypass grafts, and a history of congestive heart failure as qualities indicating a patient was at increased risk for admission. Diagnostic procedures and less acute clinical indicators decreased patients’ risk of admission. Despite the site-specific limitations of the model, these findings were supported by the literature. Conclusion Data-driven predictive analytics may be used to accurately forecast daily demand for inpatient beds for cardiac catheterization patients. Connecting these analytics to EMR data sources has the potential to provide advanced operational decision support. PMID:26342217

Architecture of a Message-Driven Processor,

DTIC Science & Technology

1987-11-01

Jon Kaplan, Paul Song, Brian Totty, and Scott Wills Artifcial Intelligence Laboratory -4 Laboratory for Computer Science Massachusetts Institute of...Information Dally, Chao, Chien, Hassoun, Horwat, Kaplan, Song, Totty & Wills: Artificial Intelligence i Laboratory and Laboratory for Computer Science, MIT...applied to a problem if we could are 36 bits long (32 data bits + 4 tag bits) and are used to hold efficiently run programs with a granularity of 5s

An Inquiry-Based Contextual Approach as the Primary Mode of Learning Science with Microcomputer-Based Laboratory Technology

ERIC Educational Resources Information Center

Espinoza, Fernando; Quarless, Duncan

2010-01-01

Science instruction can be designed to be laboratory-data driven. We report on an investigation of the use of thematic inquiry-based tasks with active incorporation of mathematics, science, and microcomputer-based laboratory technology in standards-correlated activities that enhanced learning experiences. Activities involved students in two major…

A muscle-driven approach to restore stepping with an exoskeleton for individuals with paraplegia.

PubMed

Chang, Sarah R; Nandor, Mark J; Li, Lu; Kobetic, Rudi; Foglyano, Kevin M; Schnellenberger, John R; Audu, Musa L; Pinault, Gilles; Quinn, Roger D; Triolo, Ronald J

2017-05-30

Functional neuromuscular stimulation, lower limb orthosis, powered lower limb exoskeleton, and hybrid neuroprosthesis (HNP) technologies can restore stepping in individuals with paraplegia due to spinal cord injury (SCI). However, a self-contained muscle-driven controllable exoskeleton approach based on an implanted neural stimulator to restore walking has not been previously demonstrated, which could potentially result in system use outside the laboratory and viable for long term use or clinical testing. In this work, we designed and evaluated an untethered muscle-driven controllable exoskeleton to restore stepping in three individuals with paralysis from SCI. The self-contained HNP combined neural stimulation to activate the paralyzed muscles and generate joint torques for limb movements with a controllable lower limb exoskeleton to stabilize and support the user. An onboard controller processed exoskeleton sensor signals, determined appropriate exoskeletal constraints and stimulation commands for a finite state machine (FSM), and transmitted data over Bluetooth to an off-board computer for real-time monitoring and data recording. The FSM coordinated stimulation and exoskeletal constraints to enable functions, selected with a wireless finger switch user interface, for standing up, standing, stepping, or sitting down. In the stepping function, the FSM used a sensor-based gait event detector to determine transitions between gait phases of double stance, early swing, late swing, and weight acceptance. The HNP restored stepping in three individuals with motor complete paralysis due to SCI. The controller appropriately coordinated stimulation and exoskeletal constraints using the sensor-based FSM for subjects with different stimulation systems. The average range of motion at hip and knee joints during walking were 8.5°-20.8° and 14.0°-43.6°, respectively. Walking speeds varied from 0.03 to 0.06 m/s, and cadences from 10 to 20 steps/min. A self-contained muscle-driven exoskeleton was a feasible intervention to restore stepping in individuals with paraplegia due to SCI. The untethered hybrid system was capable of adjusting to different individuals' needs to appropriately coordinate exoskeletal constraints with muscle activation using a sensor-driven FSM for stepping. Further improvements for out-of-the-laboratory use should include implantation of plantar flexor muscles to improve walking speed and power assist as needed at the hips and knees to maintain walking as muscles fatigue.

Design, implementation and multisite evaluation of a system suitability protocol for the quantitative assessment of instrument performance in liquid chromatography-multiple reaction monitoring-MS (LC-MRM-MS).

PubMed

Abbatiello, Susan E; Mani, D R; Schilling, Birgit; Maclean, Brendan; Zimmerman, Lisa J; Feng, Xingdong; Cusack, Michael P; Sedransk, Nell; Hall, Steven C; Addona, Terri; Allen, Simon; Dodder, Nathan G; Ghosh, Mousumi; Held, Jason M; Hedrick, Victoria; Inerowicz, H Dorota; Jackson, Angela; Keshishian, Hasmik; Kim, Jong Won; Lyssand, John S; Riley, C Paige; Rudnick, Paul; Sadowski, Pawel; Shaddox, Kent; Smith, Derek; Tomazela, Daniela; Wahlander, Asa; Waldemarson, Sofia; Whitwell, Corbin A; You, Jinsam; Zhang, Shucha; Kinsinger, Christopher R; Mesri, Mehdi; Rodriguez, Henry; Borchers, Christoph H; Buck, Charles; Fisher, Susan J; Gibson, Bradford W; Liebler, Daniel; Maccoss, Michael; Neubert, Thomas A; Paulovich, Amanda; Regnier, Fred; Skates, Steven J; Tempst, Paul; Wang, Mu; Carr, Steven A

2013-09-01

Multiple reaction monitoring (MRM) mass spectrometry coupled with stable isotope dilution (SID) and liquid chromatography (LC) is increasingly used in biological and clinical studies for precise and reproducible quantification of peptides and proteins in complex sample matrices. Robust LC-SID-MRM-MS-based assays that can be replicated across laboratories and ultimately in clinical laboratory settings require standardized protocols to demonstrate that the analysis platforms are performing adequately. We developed a system suitability protocol (SSP), which employs a predigested mixture of six proteins, to facilitate performance evaluation of LC-SID-MRM-MS instrument platforms, configured with nanoflow-LC systems interfaced to triple quadrupole mass spectrometers. The SSP was designed for use with low multiplex analyses as well as high multiplex approaches when software-driven scheduling of data acquisition is required. Performance was assessed by monitoring of a range of chromatographic and mass spectrometric metrics including peak width, chromatographic resolution, peak capacity, and the variability in peak area and analyte retention time (RT) stability. The SSP, which was evaluated in 11 laboratories on a total of 15 different instruments, enabled early diagnoses of LC and MS anomalies that indicated suboptimal LC-MRM-MS performance. The observed range in variation of each of the metrics scrutinized serves to define the criteria for optimized LC-SID-MRM-MS platforms for routine use, with pass/fail criteria for system suitability performance measures defined as peak area coefficient of variation <0.15, peak width coefficient of variation <0.15, standard deviation of RT <0.15 min (9 s), and the RT drift <0.5min (30 s). The deleterious effect of a marginally performing LC-SID-MRM-MS system on the limit of quantification (LOQ) in targeted quantitative assays illustrates the use and need for a SSP to establish robust and reliable system performance. Use of a SSP helps to ensure that analyte quantification measurements can be replicated with good precision within and across multiple laboratories and should facilitate more widespread use of MRM-MS technology by the basic biomedical and clinical laboratory research communities.

Design, Implementation and Multisite Evaluation of a System Suitability Protocol for the Quantitative Assessment of Instrument Performance in Liquid Chromatography-Multiple Reaction Monitoring-MS (LC-MRM-MS)*

PubMed Central

Abbatiello, Susan E.; Mani, D. R.; Schilling, Birgit; MacLean, Brendan; Zimmerman, Lisa J.; Feng, Xingdong; Cusack, Michael P.; Sedransk, Nell; Hall, Steven C.; Addona, Terri; Allen, Simon; Dodder, Nathan G.; Ghosh, Mousumi; Held, Jason M.; Hedrick, Victoria; Inerowicz, H. Dorota; Jackson, Angela; Keshishian, Hasmik; Kim, Jong Won; Lyssand, John S.; Riley, C. Paige; Rudnick, Paul; Sadowski, Pawel; Shaddox, Kent; Smith, Derek; Tomazela, Daniela; Wahlander, Asa; Waldemarson, Sofia; Whitwell, Corbin A.; You, Jinsam; Zhang, Shucha; Kinsinger, Christopher R.; Mesri, Mehdi; Rodriguez, Henry; Borchers, Christoph H.; Buck, Charles; Fisher, Susan J.; Gibson, Bradford W.; Liebler, Daniel; MacCoss, Michael; Neubert, Thomas A.; Paulovich, Amanda; Regnier, Fred; Skates, Steven J.; Tempst, Paul; Wang, Mu; Carr, Steven A.

2013-01-01

Multiple reaction monitoring (MRM) mass spectrometry coupled with stable isotope dilution (SID) and liquid chromatography (LC) is increasingly used in biological and clinical studies for precise and reproducible quantification of peptides and proteins in complex sample matrices. Robust LC-SID-MRM-MS-based assays that can be replicated across laboratories and ultimately in clinical laboratory settings require standardized protocols to demonstrate that the analysis platforms are performing adequately. We developed a system suitability protocol (SSP), which employs a predigested mixture of six proteins, to facilitate performance evaluation of LC-SID-MRM-MS instrument platforms, configured with nanoflow-LC systems interfaced to triple quadrupole mass spectrometers. The SSP was designed for use with low multiplex analyses as well as high multiplex approaches when software-driven scheduling of data acquisition is required. Performance was assessed by monitoring of a range of chromatographic and mass spectrometric metrics including peak width, chromatographic resolution, peak capacity, and the variability in peak area and analyte retention time (RT) stability. The SSP, which was evaluated in 11 laboratories on a total of 15 different instruments, enabled early diagnoses of LC and MS anomalies that indicated suboptimal LC-MRM-MS performance. The observed range in variation of each of the metrics scrutinized serves to define the criteria for optimized LC-SID-MRM-MS platforms for routine use, with pass/fail criteria for system suitability performance measures defined as peak area coefficient of variation <0.15, peak width coefficient of variation <0.15, standard deviation of RT <0.15 min (9 s), and the RT drift <0.5min (30 s). The deleterious effect of a marginally performing LC-SID-MRM-MS system on the limit of quantification (LOQ) in targeted quantitative assays illustrates the use and need for a SSP to establish robust and reliable system performance. Use of a SSP helps to ensure that analyte quantification measurements can be replicated with good precision within and across multiple laboratories and should facilitate more widespread use of MRM-MS technology by the basic biomedical and clinical laboratory research communities. PMID:23689285

Clinical pathologist in Korea--training program and its roles in laboratories.

PubMed

Cho, Han-Ik; Lee, Kap No; Park, Jong-Woo; Park, Hyosoon; Kwak, Yun Sik

2002-01-01

A rapid development of practice of laboratory medicine in Korea owes its success to the clinical pathologists (CP), who have played a role of a pathfinder for laboratories. The Korean CP postgraduate education (residency) program is unique in that it is exclusively for laboratory medicine. The training program for clinical pathologists includes diagnostic hematology, diagnostic immunology, clinical microbiology, clinical chemistry, blood bank, diagnostic genetics, informatics and laboratory management. The program has produced a strong group of about 600 laboratory physicians, officially clinical pathologists since 1963. Most of Korean clinical pathologists work as laboratory directors, directors of university hospital laboratories or teaching faculty members in medical schools. The roles of clinical pathologists are laboratory management, interpretation of laboratory test results, clinical consulting services to clinicians and patients, ordering secondary tests after reviews of requested test results and utilization management. The clinical pathologists have developed clinical laboratories to be a main contributor for improved medical practice. During the last 40 years under the turbulent healthcare system, clinical pathologists have significantly contributed to safeguard the laboratory interests. The education program and the role of clinical pathologists are described.

Pathology Consultation on Viscoelastic Studies of Coagulopathic Obstetrical Patients.

PubMed

Gehrie, Eric A; Baine, Ian; Booth, Garrett S

2016-08-01

In obstetrics, the decision to transfuse blood components has historically been driven by traditional laboratory testing in combination with direct observation of bleeding. The adjunctive use of viscoelastic testing, including thromboelastometry and thromboelastography, has gained increasing acceptance in the clinical domain. We performed a review of the published medical literature by searching the PUBMED database for keywords "viscoelastic" and "obstetric," as well as "viscoelastic" and "postpartum hemorrhage." Additionally, case reports and expert opinion publications that referenced viscoelastic studies in obstetrical patients were evaluated. There is very little high-quality evidence currently published in the medical literature to support the notion that viscoelastic testing obviates the need for traditional coagulation testing or improves mortality resulting from major obstetrical hemorrhage. Additional research is needed to further focus the optimum role of viscoelastic tests in major obstetrical hemorrhage. © American Society for Clinical Pathology, 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Integrating Undergraduate Students in Faculty-Driven Motor Behavior Research

ERIC Educational Resources Information Center

Robinson, Leah E.

2013-01-01

This article described the faculty-sponsored, faculty-driven approach to undergraduate research (UGR) at Auburn University. This approach is centered around research in the Pediatric Movement and Physical Activity Laboratory, and students can get elective course credit for their participation in UGR. The article also describes how students' roles…

Using HeLa Cell Stress Response to Introduce First Year Students to the Scientific Method, Laboratory Techniques, Primary Literature, and Scientific Writing

ERIC Educational Resources Information Center

Resendes, Karen K.

2015-01-01

Incorporating scientific literacy into inquiry driven research is one of the most effective mechanisms for developing an undergraduate student's strength in writing. Additionally, discovery-based laboratories help develop students who approach science as critical thinkers. Thus, a three-week laboratory module for an introductory cell and molecular…

Doing That Thing That Scientists Do: A Discovery-Driven Module on Protein Purification and Characterization for the Undergraduate Biochemistry Laboratory Classroom

ERIC Educational Resources Information Center

Garrett, Teresa A.; Osmundson, Joseph; Isaacson, Marisa; Herrera, Jennifer

2015-01-01

In traditional introductory biochemistry laboratory classes students learn techniques for protein purification and analysis by following provided, established, step-by-step procedures. Students are exposed to a variety of biochemical techniques but are often not developing procedures or collecting new, original data. In this laboratory module,…

Immunological research in clinical psychiatry: report on the consensus debate during the 7th Expert Meeting on Psychiatry and Immunology.

PubMed

Arolt, V; Rothermundt, M; Peters, M; Leonard, B

2002-01-01

There is convincing evidence that cytokines are involved in the physiology and pathophysiology of brain function and interact with different neurotransmitter and neuroendocrine pathways. The possible involvement of the immune system in the neurobiological mechanisms that underlie psychiatric disorders has attracted increasing attention in recent years. Thus in the last decade, numerous clinical studies have demonstrated dysregulated immune functions in patients with psychiatric disorders. Such findings formed the basis of the 7th Expert Meeting on Psychiatry and Immunology in Muenster, Germany, where a consensus symposium was held to consider the strengths and weaknesses of current research in psychoneuroimmunology. Following a general overview of the field, the following topics were discussed: (1) methodological problems in laboratory procedures and recruitment of clinical samples; (2) the importance of pre-clinical research and animal models in psychiatric research; (3) the problem of statistical vs biological relevance. It was concluded that, despite a fruitful proliferation of research activities throughout the last decade, the continuous elaboration of methodological standards including the implementation of hypothesis-driven research represents a task that is likely to prove crucial for the future development of immunology research in clinical psychiatry.

The Stanford Data Miner: a novel approach for integrating and exploring heterogeneous immunological data.

PubMed

Siebert, Janet C; Munsil, Wes; Rosenberg-Hasson, Yael; Davis, Mark M; Maecker, Holden T

2012-03-28

Systems-level approaches are increasingly common in both murine and human translational studies. These approaches employ multiple high information content assays. As a result, there is a need for tools to integrate heterogeneous types of laboratory and clinical/demographic data, and to allow the exploration of that data by aggregating and/or segregating results based on particular variables (e.g., mean cytokine levels by age and gender). Here we describe the application of standard data warehousing tools to create a novel environment for user-driven upload, integration, and exploration of heterogeneous data. The system presented here currently supports flow cytometry and immunoassays performed in the Stanford Human Immune Monitoring Center, but could be applied more generally. Users upload assay results contained in platform-specific spreadsheets of a defined format, and clinical and demographic data in spreadsheets of flexible format. Users then map sample IDs to connect the assay results with the metadata. An OLAP (on-line analytical processing) data exploration interface allows filtering and display of various dimensions (e.g., Luminex analytes in rows, treatment group in columns, filtered on a particular study). Statistics such as mean, median, and N can be displayed. The views can be expanded or contracted to aggregate or segregate data at various levels. Individual-level data is accessible with a single click. The result is a user-driven system that permits data integration and exploration in a variety of settings. We show how the system can be used to find gender-specific differences in serum cytokine levels, and compare them across experiments and assay types. We have used the tools and techniques of data warehousing, including open-source business intelligence software, to support investigator-driven data integration and mining of diverse immunological data.

The Stanford Data Miner: a novel approach for integrating and exploring heterogeneous immunological data

PubMed Central

2012-01-01

Background Systems-level approaches are increasingly common in both murine and human translational studies. These approaches employ multiple high information content assays. As a result, there is a need for tools to integrate heterogeneous types of laboratory and clinical/demographic data, and to allow the exploration of that data by aggregating and/or segregating results based on particular variables (e.g., mean cytokine levels by age and gender). Methods Here we describe the application of standard data warehousing tools to create a novel environment for user-driven upload, integration, and exploration of heterogeneous data. The system presented here currently supports flow cytometry and immunoassays performed in the Stanford Human Immune Monitoring Center, but could be applied more generally. Results Users upload assay results contained in platform-specific spreadsheets of a defined format, and clinical and demographic data in spreadsheets of flexible format. Users then map sample IDs to connect the assay results with the metadata. An OLAP (on-line analytical processing) data exploration interface allows filtering and display of various dimensions (e.g., Luminex analytes in rows, treatment group in columns, filtered on a particular study). Statistics such as mean, median, and N can be displayed. The views can be expanded or contracted to aggregate or segregate data at various levels. Individual-level data is accessible with a single click. The result is a user-driven system that permits data integration and exploration in a variety of settings. We show how the system can be used to find gender-specific differences in serum cytokine levels, and compare them across experiments and assay types. Conclusions We have used the tools and techniques of data warehousing, including open-source business intelligence software, to support investigator-driven data integration and mining of diverse immunological data. PMID:22452993

Building an Ontology-driven Database for Clinical Immune Research

PubMed Central

Ma, Jingming

2006-01-01

The clinical researches of immune response usually generate a huge amount of biomedical testing data over a certain period of time. The user-friendly data management systems based on the relational database will help immunologists/clinicians to fully manage the data. On the other hand, the same biological assays such as ELISPOT and flow cytometric assays are involved in immunological experiments no matter of different study purposes. The reuse of biological knowledge is one of driving forces behind this ontology-driven data management. Therefore, an ontology-driven database will help to handle different clinical immune researches and help immunologists/clinicians easily understand the immunological data from each other. We will discuss some outlines for building an ontology-driven data management for clinical immune researches (ODMim). PMID:17238637

Toward laboratory torsional spine magnetic reconnection

NASA Astrophysics Data System (ADS)

Chesny, David L.; Orange, N. Brice; Oluseyi, Hakeem M.; Valletta, David R.

2017-12-01

Magnetic reconnection is a fundamental energy conversion mechanism in nature. Major attempts to study this process in controlled settings on Earth have largely been limited to reproducing approximately two-dimensional (2-D) reconnection dynamics. Other experiments describing reconnection near three-dimensional null points are non-driven, and do not induce any of the 3-D modes of spine fan, torsional fan or torsional spine reconnection. In order to study these important 3-D modes observed in astrophysical plasmas (e.g. the solar atmosphere), laboratory set-ups must be designed to induce driven reconnection about an isolated magnetic null point. As such, we consider the limited range of fundamental resistive magnetohydrodynamic (MHD) and kinetic parameters of dynamic laboratory plasmas that are necessary to induce the torsional spine reconnection (TSR) mode characterized by a driven rotational slippage of field lines - a feature that has yet to be achieved in operational laboratory magnetic reconnection experiments. Leveraging existing reconnection models, we show that within a 3$ apparatus, TSR can be achieved in dense plasma regimes ( 24~\\text{m}-3$ ) in magnetic fields of -1~\\text{T}$ . We find that MHD and kinetic parameters predict reconnection in thin current sheets on time scales of . While these plasma regimes may not explicitly replicate the plasma parameters of observed astrophysical phenomena, studying the dynamics of the TSR mode within achievable set-ups signifies an important step in understanding the fundamentals of driven 3-D magnetic reconnection and the self-organization of current sheets. Explicit control of this reconnection mode may have implications for understanding particle acceleration in astrophysical environments, and may even have practical applications to fields such as spacecraft propulsion.

Oxy-acetylene driven laboratory scale shock tubes for studying blast wave effects

NASA Astrophysics Data System (ADS)

Courtney, Amy C.; Andrusiv, Lubov P.; Courtney, Michael W.

2012-04-01

This paper describes the development and characterization of modular, oxy-acetylene driven laboratory scale shock tubes. Such tools are needed to produce realistic blast waves in a laboratory setting. The pressure-time profiles measured at 1 MHz using high-speed piezoelectric pressure sensors have relevant durations and show a true shock front and exponential decay characteristic of free-field blast waves. Descriptions are included for shock tube diameters of 27-79 mm. A range of peak pressures from 204 kPa to 1187 kPa (with 0.5-5.6% standard error of the mean) were produced by selection of the driver section diameter and distance from the shock tube opening. The peak pressures varied predictably with distance from the shock tube opening while maintaining both a true blast wave profile and relevant pulse duration for distances up to about one diameter from the shock tube opening. This shock tube design provides a more realistic blast profile than current compression-driven shock tubes, and it does not have a large jet effect. In addition, operation does not require specialized personnel or facilities like most blast-driven shock tubes, which reduces operating costs and effort and permits greater throughput and accessibility. It is expected to be useful in assessing the response of various sensors to shock wave loading; assessing the reflection, transmission, and absorption properties of candidate armor materials; assessing material properties at high rates of loading; assessing the response of biological materials to shock wave exposure; and providing a means to validate numerical models of the interaction of shock waves with structures. All of these activities have been difficult to pursue in a laboratory setting due in part to lack of appropriate means to produce a realistic blast loading profile.

NORDA’s Pattern Analysis Laboratory: Current Contributions to Naval Mapping, Charting, and Geodesy

DTIC Science & Technology

1989-04-01

magnetic observatories (McLeod, 1988). Using system integrates a suite of sensors and control devices the PAL’s VAX 11/780, spherical harmonic models to...DJAO:[FPS]*.OLB 5. Miscellaneous Utilities CALENDAR (NORDA events) 780 $ CALENDAR (menu-driven) DIALER modem controller 780 $ R AUTO DIAL:DIALER DTC...Utilities CALENDAR (NORDA events) 780 CALENDAR (menu-driven) DIALER modem controller 780 $ R AUTO DIAL:DIALER DTC Desk Top Calendar 780 $ DTC (menu-driven

The History of the AutoChemist®: From Vision to Reality.

PubMed

Peterson, H E; Jungner, I

2014-05-22

This paper discusses the early history and development of a clinical analyser system in Sweden (AutoChemist, 1965). It highlights the importance of such high capacity system both for clinical use and health care screening. The device was developed to assure the quality of results and to automatically handle the orders, store the results in digital form for later statistical analyses and distribute the results to the patients' physicians by using the computer used for the analyser. The most important result of the construction of an analyser able to produce analytical results on a mass scale was the development of a mechanical multi-channel analyser for clinical laboratories that handled discrete sample technology and could prevent carry-over to the next test samples while incorporating computer technology to improve the quality of test results. The AutoChemist could handle 135 samples per hour in an 8-hour shift and up to 24 possible analyses channels resulting in 3,200 results per hour. Later versions would double this capacity. Some customers used the equipment 24 hours per day. With a capacity of 3,000 to 6,000 analyses per hour, pneumatic driven pipettes, special units for corrosive liquids or special activities, and an integrated computer, the AutoChemist system was unique and the largest of its kind for many years. Its follower - The AutoChemist PRISMA (PRogrammable Individually Selective Modular Analyzer) - was smaller in size but had a higher capacity. Both analysers established new standards of operation for clinical laboratories and encouraged others to use new technologies for building new analysers.

Improved compliance by BPM-driven workflow automation.

PubMed

Holzmüller-Laue, Silke; Göde, Bernd; Fleischer, Heidi; Thurow, Kerstin

2014-12-01

Using methods and technologies of business process management (BPM) for the laboratory automation has important benefits (i.e., the agility of high-level automation processes, rapid interdisciplinary prototyping and implementation of laboratory tasks and procedures, and efficient real-time process documentation). A principal goal of the model-driven development is the improved transparency of processes and the alignment of process diagrams and technical code. First experiences of using the business process model and notation (BPMN) show that easy-to-read graphical process models can achieve and provide standardization of laboratory workflows. The model-based development allows one to change processes quickly and an easy adaption to changing requirements. The process models are able to host work procedures and their scheduling in compliance with predefined guidelines and policies. Finally, the process-controlled documentation of complex workflow results addresses modern laboratory needs of quality assurance. BPMN 2.0 as an automation language to control every kind of activity or subprocess is directed to complete workflows in end-to-end relationships. BPMN is applicable as a system-independent and cross-disciplinary graphical language to document all methods in laboratories (i.e., screening procedures or analytical processes). That means, with the BPM standard, a communication method of sharing process knowledge of laboratories is also available. © 2014 Society for Laboratory Automation and Screening.

Bar-Code System for a Microbiological Laboratory

NASA Technical Reports Server (NTRS)

Law, Jennifer; Kirschner, Larry

2007-01-01

A bar-code system has been assembled for a microbiological laboratory that must examine a large number of samples. The system includes a commercial bar-code reader, computer hardware and software components, plus custom-designed database software. The software generates a user-friendly, menu-driven interface.

Phenotype-driven molecular autopsy for sudden cardiac death.

PubMed

Cann, F; Corbett, M; O'Sullivan, D; Tennant, S; Hailey, H; Grieve, J H K; Broadhurst, P; Rankin, R; Dean, J C S

2017-01-01

A phenotype-driven approach to molecular autopsy based in a multidisciplinary team comprising clinical and laboratory genetics, forensic medicine and cardiology is described. Over a 13 year period, molecular autopsy was undertaken in 96 sudden cardiac death cases. A total of 46 cases aged 1-40 years had normal hearts and suspected arrhythmic death. Seven (15%) had likely pathogenic variants in ion channelopathy genes [KCNQ1 (1), KCNH2 (4), SCN5A (1), RyR2(1)]. Fifty cases aged between 2 and 67 had a cardiomyopathy. Twenty-five had arrhythmogenic right ventricular cardiomyopathy (ARVC), 10 dilated cardiomyopathy (DCM) and 15 hypertrophic cardiomyopathy (HCM). Likely pathogenic variants were found in three ARVC cases (12%) in PKP2, DSC2 or DSP, two DCM cases (20%) in MYH7, and four HCM cases (27%) in MYBPC3 (3) or MYH7 (1). Uptake of cascade screening in relatives was higher when a molecular diagnosis was made at autopsy. In three families, variants previously published as pathogenic were detected, but clinical investigation revealed no abnormalities in carrier relatives. With a conservative approach to defining pathogenicity of sequence variants incorporating family phenotype information and population genomic data, a molecular diagnosis was made in 15% of sudden arrhythmic deaths and 18% of cardiomyopathy deaths. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

42 CFR 414.510 - Laboratory date of service for clinical laboratory and pathology specimens.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false Laboratory date of service for clinical laboratory... AND OTHER HEALTH SERVICES Payment for New Clinical Diagnostic Laboratory Tests § 414.510 Laboratory date of service for clinical laboratory and pathology specimens. The date of service for either a...

Influence of analytical bias and imprecision on the number of false positive results using Guideline-Driven Medical Decision Limits.

PubMed

Hyltoft Petersen, Per; Klee, George G

2014-03-20

Diagnostic decisions based on decision limits according to medical guidelines are different from the majority of clinical decisions due to the strict dichotomization of patients into diseased and non-diseased. Consequently, the influence of analytical performance is more critical than for other diagnostic decisions where much other information is included. The aim of this opinion paper is to investigate consequences of analytical quality and other circumstances for the outcome of "Guideline-Driven Medical Decision Limits". Effects of analytical bias and imprecision should be investigated separately and analytical quality specifications should be estimated accordingly. Use of sharp decision limits doesn't consider biological variation and effects of this variation are closely connected with the effects of analytical performance. Such relationships are investigated for the guidelines for HbA1c in diagnosis of diabetes and in risk of coronary heart disease based on serum cholesterol. The effects of a second sampling in diagnosis give dramatic reduction in the effects of analytical quality showing minimal influence of imprecision up to 3 to 5% for two independent samplings, whereas the reduction in bias is more moderate and a 2% increase in concentration doubles the percentage of false positive diagnoses, both for HbA1c and cholesterol. An alternative approach comes from the current application of guidelines for follow-up laboratory tests according to clinical procedure orders, e.g. frequency of parathyroid hormone requests as a function of serum calcium concentrations. Here, the specifications for bias can be evaluated from the functional increase in requests for increasing serum calcium concentrations. In consequence of the difficulties with biological variation and the practical utilization of concentration dependence of frequency of follow-up laboratory tests already in use, a kind of probability function for diagnosis as function of the key-analyte is proposed. Copyright © 2013 Elsevier B.V. All rights reserved.

Reprint of "Influence of analytical bias and imprecision on the number of false positive results using Guideline-Driven Medical Decision Limits".

PubMed

Hyltoft Petersen, Per; Klee, George G

2014-05-15

Diagnostic decisions based on decision limits according to medical guidelines are different from the majority of clinical decisions due to the strict dichotomization of patients into diseased and non-diseased. Consequently, the influence of analytical performance is more critical than for other diagnostic decisions where much other information is included. The aim of this opinion paper is to investigate consequences of analytical quality and other circumstances for the outcome of "Guideline-Driven Medical Decision Limits". Effects of analytical bias and imprecision should be investigated separately and analytical quality specifications should be estimated accordingly. Use of sharp decision limits doesn't consider biological variation and effects of this variation are closely connected with the effects of analytical performance. Such relationships are investigated for the guidelines for HbA1c in diagnosis of diabetes and in risk of coronary heart disease based on serum cholesterol. The effects of a second sampling in diagnosis give dramatic reduction in the effects of analytical quality showing minimal influence of imprecision up to 3 to 5% for two independent samplings, whereas the reduction in bias is more moderate and a 2% increase in concentration doubles the percentage of false positive diagnoses, both for HbA1c and cholesterol. An alternative approach comes from the current application of guidelines for follow-up laboratory tests according to clinical procedure orders, e.g. frequency of parathyroid hormone requests as a function of serum calcium concentrations. Here, the specifications for bias can be evaluated from the functional increase in requests for increasing serum calcium concentrations. In consequence of the difficulties with biological variation and the practical utilization of concentration dependence of frequency of follow-up laboratory tests already in use, a kind of probability function for diagnosis as function of the key-analyte is proposed. Copyright © 2014. Published by Elsevier B.V.

Data-driven approach for creating synthetic electronic medical records.

PubMed

Buczak, Anna L; Babin, Steven; Moniz, Linda

2010-10-14

New algorithms for disease outbreak detection are being developed to take advantage of full electronic medical records (EMRs) that contain a wealth of patient information. However, due to privacy concerns, even anonymized EMRs cannot be shared among researchers, resulting in great difficulty in comparing the effectiveness of these algorithms. To bridge the gap between novel bio-surveillance algorithms operating on full EMRs and the lack of non-identifiable EMR data, a method for generating complete and synthetic EMRs was developed. This paper describes a novel methodology for generating complete synthetic EMRs both for an outbreak illness of interest (tularemia) and for background records. The method developed has three major steps: 1) synthetic patient identity and basic information generation; 2) identification of care patterns that the synthetic patients would receive based on the information present in real EMR data for similar health problems; 3) adaptation of these care patterns to the synthetic patient population. We generated EMRs, including visit records, clinical activity, laboratory orders/results and radiology orders/results for 203 synthetic tularemia outbreak patients. Validation of the records by a medical expert revealed problems in 19% of the records; these were subsequently corrected. We also generated background EMRs for over 3000 patients in the 4-11 yr age group. Validation of those records by a medical expert revealed problems in fewer than 3% of these background patient EMRs and the errors were subsequently rectified. A data-driven method was developed for generating fully synthetic EMRs. The method is general and can be applied to any data set that has similar data elements (such as laboratory and radiology orders and results, clinical activity, prescription orders). The pilot synthetic outbreak records were for tularemia but our approach may be adapted to other infectious diseases. The pilot synthetic background records were in the 4-11 year old age group. The adaptations that must be made to the algorithms to produce synthetic background EMRs for other age groups are indicated.

The Case for Laboratory Developed Procedures

PubMed Central

Sabatini, Linda M.; Tsongalis, Gregory J.; Caliendo, Angela M.; Olsen, Randall J.; Ashwood, Edward R.; Bale, Sherri; Benirschke, Robert; Carlow, Dean; Funke, Birgit H.; Grody, Wayne W.; Hayden, Randall T.; Hegde, Madhuri; Lyon, Elaine; Pessin, Melissa; Press, Richard D.; Thomson, Richard B.

2017-01-01

An explosion of knowledge and technology is revolutionizing medicine and patient care. Novel testing must be brought to the clinic with safety and accuracy, but also in a timely and cost-effective manner, so that patients can benefit and laboratories can offer testing consistent with current guidelines. Under the oversight provided by the Clinical Laboratory Improvement Amendments, laboratories have been able to develop and optimize laboratory procedures for use in-house. Quality improvement programs, interlaboratory comparisons, and the ability of laboratories to adjust assays as needed to improve results, utilize new sample types, or incorporate new mutations, information, or technologies are positive aspects of Clinical Laboratory Improvement Amendments oversight of laboratory-developed procedures. Laboratories have a long history of successful service to patients operating under Clinical Laboratory Improvement Amendments. A series of detailed clinical examples illustrating the quality and positive impact of laboratory-developed procedures on patient care is provided. These examples also demonstrate how Clinical Laboratory Improvement Amendments oversight ensures accurate, reliable, and reproducible testing in clinical laboratories. PMID:28815200

Experimental Investigations on the Surface-Driven Capillary Flow of Aqueous Microparticle Suspensions in the Microfluidic Laboratory-On Systems

NASA Astrophysics Data System (ADS)

Mukhopadhyay, Subhadeep

In this work, total 1592 individual leakage-free polymethylmethacrylate (PMMA) microfluidic devices as laboratory-on-a-chip systems are fabricated by maskless lithography, hot embossing lithography, and direct bonding technique. Total 1094 individual Audio Video Interleave Files as experimental outputs related to the surface-driven capillary flow have been recorded and analyzed. The influence of effective viscosity, effect of surface wettability, effect of channel aspect ratio, and effect of centrifugal force on the surface-driven microfluidic flow of aqueous microparticle suspensions have been successfully and individually investigated in these laboratory-on-a-chip systems. Also, 5 micron polystyrene particles have been separated from the aqueous microparticle suspensions in the microfluidic lab-on-a-chip systems of modified design with 98% separation efficiency, and 10 micron polystyrene particles have been separated with 100% separation efficiency. About the novelty of this work, the experimental investigations have been performed on the surface-driven microfluidic flow of aqueous microparticle suspensions with the investigations on the separation time in particle-size based separation mechanism to control these suspensions in the microfluidic lab-on-a-chip systems. This research work contains a total of 10,112 individual experimental outputs obtained using total 30 individual instruments by author’s own hands-on completely during more than three years continuously. Author has performed the experimental investigations on both the fluid statics and fluid dynamics to develop an automated fluid machine.

76 FR 82299 - Clinical Laboratory Improvement Advisory Committee (CLIAC)

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-30

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Clinical... under which clinical laboratories are regulated; the impact on medical and laboratory practice of... the Clinical Laboratory Workforce; laboratory communication and electronic health records, integration...

Investigating Wind-Driven Rain Intrusion in Walls with the CARWASh

Treesearch

C.R. Boardman; Samuel V. Glass

2013-01-01

Wind-driven rain provides the primary external moisture load for exterior walls.Water absorption by the cladding, runoff, and penetration through the cladding or at details determine how a wall system performs. In this paper we describe a new laboratory facility that can create controlled outdoor and indoor conditions and use it to investigate the water...

Implementing a Student-Designed Green Chemistry Laboratory Project in Organic Chemistry

ERIC Educational Resources Information Center

Graham, Kate J.; Jones, T. Nicholas; Schaller, Chris P.; McIntee, Edward J.

2014-01-01

A multiweek organic chemistry laboratory project is described that emphasizes sustainable practices in experimental design. An emphasis on student-driven development of the project is meant to mirror the independent nature of research. Students propose environmentally friendly modifications of several reactions. With instructor feedback, students…

New Partnership Could Help Identify Drugs to Target Cancers Driven by KRAS Mutations | Frederick National Laboratory for Cancer Research

Cancer.gov

More than 100,000 newly diagnosed cases of cancer each year in the United States are subsequently linked to mutations in the KRAS protein. In response to this urgent problem, a new partnership agreement involving the Frederick National Laboratory for

42 CFR 414.508 - Payment for a new clinical diagnostic laboratory test.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false Payment for a new clinical diagnostic laboratory... SERVICES Payment for New Clinical Diagnostic Laboratory Tests § 414.508 Payment for a new clinical diagnostic laboratory test. For a new clinical diagnostic laboratory test that is assigned a new or...

42 CFR 414.508 - Payment for a new clinical diagnostic laboratory test.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 3 2011-10-01 2011-10-01 false Payment for a new clinical diagnostic laboratory... SERVICES Payment for New Clinical Diagnostic Laboratory Tests § 414.508 Payment for a new clinical diagnostic laboratory test. For a new clinical diagnostic laboratory test that is assigned a new or...

Childhood polycythemias/erythrocytoses: classification, diagnosis, clinical presentation, and treatment.

PubMed

Cario, H

2005-03-01

Polycythemias or erythrocytoses in childhood and adolescence are very rare. Systematic data on the clinical presentation and laboratory evaluations as well as on treatment regimens are sparse. The diagnostic program in absolute erythrocytosis includes extensive clinical, hematological, biochemical, and molecular biological examinations which should be applied following a stepwise algorithm. Absolute erythrocytoses are usually subdivided into primary and secondary forms. Primary erythrocytosis is a condition in which the erythropoietic compartment is expanding independently of extrinsic influences or by responding inadequately to them. Primary erythrocytoses include primary familial and congenital polycythemia (PFCP) due to mutations of the erythropoietin (Epo) receptor gene and the myeloproliferative disorder polycythemia vera. Secondary erythrocytoses are driven by hormonal factors (predominantly by Epo) extrinsic to the erythroid compartment. The increased Epo secretion may represent either a physiologic response to tissue hypoxia, an abnormal autonomous Epo production, or a dysregulation of the oxygen-dependent Epo synthesis. Congenital secondary erythrocytoses are caused, e.g., by hemoglobin variants with increased oxygen affinity, by 2,3-bisphosphoglycerate deficiency, or by mutations in the von Hippel-Lindau gene associated with a disturbed oxygen-dependent regulation of Epo synthesis.

Ethics, morality, and conflicting interests: how questionable professional integrity in some scientists supports global corporate influence in public health.

PubMed

Baur, Xaver; Budnik, Lygia Therese; Ruff, Kathleen; Egilman, David S; Lemen, Richard A; Soskolne, Colin L

2015-01-01

Clinical and public health research, education, and medical practice are vulnerable to influence by corporate interests driven by the for-profit motive. Developments over the last 10 years have shown that transparency and self-reporting of corporate ties do not always mitigate bias. In this article, we provide examples of how sound scientific reasoning and evidence-gathering are undermined through compromised scientific enquiry resulting in misleading science, decision-making, and policy intervention. Various medical disciplines provide reference literature essential for informing public, environmental, and occupational health policy. Published literature impacts clinical and laboratory methods, the validity of respective clinical guidelines, and the development and implementation of public health regulations. Said literature is also used in expert testimony related to resolving tort actions on work-related illnesses and environmental risks. We call for increased sensitivity, full transparency, and the implementation of effective ethical and professional praxis rules at all relevant regulatory levels to rout out inappropriate corporate influence in science. This is needed because influencing the integrity of scientists who engage in such activities cannot be depended upon.

Generation and Evolution of High-Mach-Number Laser-Driven Magnetized Collisionless Shocks in the Laboratory.

PubMed

Schaeffer, D B; Fox, W; Haberberger, D; Fiksel, G; Bhattacharjee, A; Barnak, D H; Hu, S X; Germaschewski, K

2017-07-14

We present the first laboratory generation of high-Mach-number magnetized collisionless shocks created through the interaction of an expanding laser-driven plasma with a magnetized ambient plasma. Time-resolved, two-dimensional imaging of plasma density and magnetic fields shows the formation and evolution of a supercritical shock propagating at magnetosonic Mach number M_{ms}≈12. Particle-in-cell simulations constrained by experimental data further detail the shock formation and separate dynamics of the multi-ion-species ambient plasma. The results show that the shocks form on time scales as fast as one gyroperiod, aided by the efficient coupling of energy, and the generation of a magnetic barrier between the piston and ambient ions. The development of this experimental platform complements present remote sensing and spacecraft observations, and opens the way for controlled laboratory investigations of high-Mach number collisionless shocks, including the mechanisms and efficiency of particle acceleration.

A plasma deflagration accelerator as a platform for laboratory astrophysics

NASA Astrophysics Data System (ADS)

Underwood, Thomas C.; Loebner, Keith T. K.; Cappelli, Mark A.

2017-06-01

The replication of astrophysical flows in the laboratory is critical for isolating particular phenomena and dynamics that appear in complex, highly-coupled natural systems. In particular, plasma jets are observed in astrophysical contexts at a variety of scales, typically at high magnetic Reynolds number and driven by internal currents. In this paper, we present detailed measurements of the plasma parameters within deflagration-produced plasma jets, the scaling of these parameters against both machine operating conditions and the corresponding astrophysical phenomena. Using optical and spectroscopic diagnostics, including Schlieren cinematography, we demonstrate the production of current-driven plasma jets of ∼100 km/s and magnetic Reynolds numbers of ∼100, and discuss the dynamics of their acceleration into vacuum. The results of this study will contribute to the reproduction of various types of astrophysical jets in the laboratory and indicate the ability to further probe active research areas such as jet collimation, stability, and interaction.

Clinical laboratory analytics: Challenges and promise for an emerging discipline.

PubMed

Shirts, Brian H; Jackson, Brian R; Baird, Geoffrey S; Baron, Jason M; Clements, Bryan; Grisson, Ricky; Hauser, Ronald George; Taylor, Julie R; Terrazas, Enrique; Brimhall, Brad

2015-01-01

The clinical laboratory is a major source of health care data. Increasingly these data are being integrated with other data to inform health system-wide actions meant to improve diagnostic test utilization, service efficiency, and "meaningful use." The Academy of Clinical Laboratory Physicians and Scientists hosted a satellite meeting on clinical laboratory analytics in conjunction with their annual meeting on May 29, 2014 in San Francisco. There were 80 registrants for the clinical laboratory analytics meeting. The meeting featured short presentations on current trends in clinical laboratory analytics and several panel discussions on data science in laboratory medicine, laboratory data and its role in the larger healthcare system, integrating laboratory analytics, and data sharing for collaborative analytics. One main goal of meeting was to have an open forum of leaders that work with the "big data" clinical laboratories produce. This article summarizes the proceedings of the meeting and content discussed.

Clinical laboratory analytics: Challenges and promise for an emerging discipline

PubMed Central

Shirts, Brian H.; Jackson, Brian R.; Baird, Geoffrey S.; Baron, Jason M.; Clements, Bryan; Grisson, Ricky; Hauser, Ronald George; Taylor, Julie R.; Terrazas, Enrique; Brimhall, Brad

2015-01-01

The clinical laboratory is a major source of health care data. Increasingly these data are being integrated with other data to inform health system-wide actions meant to improve diagnostic test utilization, service efficiency, and “meaningful use.” The Academy of Clinical Laboratory Physicians and Scientists hosted a satellite meeting on clinical laboratory analytics in conjunction with their annual meeting on May 29, 2014 in San Francisco. There were 80 registrants for the clinical laboratory analytics meeting. The meeting featured short presentations on current trends in clinical laboratory analytics and several panel discussions on data science in laboratory medicine, laboratory data and its role in the larger healthcare system, integrating laboratory analytics, and data sharing for collaborative analytics. One main goal of meeting was to have an open forum of leaders that work with the “big data” clinical laboratories produce. This article summarizes the proceedings of the meeting and content discussed. PMID:25774320

Therapeutic Approach to the Management of Severe Asymptomatic Hyponatremia.

PubMed

Ijaiya, Thaofiq; Manohar, Sandhya; Lakshmi, Kameswari

2017-01-01

Hyponatremia is an electrolyte imbalance encountered commonly in the hospital and ambulatory settings. It can be seen in isolation or present as a complication of other medical conditions. It is therefore a challenge to determine the appropriate therapeutic intervention. An understanding of the etiology is key in instituting the right treatment. Clinicians must not be too hasty to correct a random laboratory value without first understanding the physiologic principle. We present such a case of a patient who presented with sodium of 98 mmol/L, the lowest recorded in the current literature, and yet was asymptomatic. Following appropriate management driven by an understanding of the underlying pathophysiologic mechanism, the patient was managed to full recovery without any clinically significant neurological sequelae.

How does audit and feedback influence intentions of health professionals to improve practice? A laboratory experiment and field study in cardiac rehabilitation.

PubMed

Gude, Wouter T; van Engen-Verheul, Mariëtte M; van der Veer, Sabine N; de Keizer, Nicolette F; Peek, Niels

2017-04-01

To identify factors that influence the intentions of health professionals to improve their practice when confronted with clinical performance feedback, which is an essential first step in the audit and feedback mechanism. We conducted a theory-driven laboratory experiment with 41 individual professionals, and a field study in 18 centres in the context of a cluster-randomised trial of electronic audit and feedback in cardiac rehabilitation. Feedback reports were provided through a web-based application, and included performance scores and benchmark comparisons (high, intermediate or low performance) for a set of process and outcome indicators. From each report participants selected indicators for improvement into their action plan. Our unit of observation was an indicator presented in a feedback report (selected yes/no); we considered selecting an indicator to reflect an intention to improve. We analysed 767 observations in the laboratory experiment and 614 in the field study, respectively. Each 10% decrease in performance score increased the probability of an indicator being selected by 54% (OR, 1.54; 95% CI 1.29% to 1.83%) in the laboratory experiment, and 25% (OR, 1.25; 95% CI 1.13% to 1.39%) in the field study. Also, performance being benchmarked as low and intermediate increased this probability in laboratory settings. Still, participants ignored the benchmarks in 34% (laboratory experiment) and 48% (field study) of their selections. When confronted with clinical performance feedback, performance scores and benchmark comparisons influenced health professionals' intentions to improve practice. However, there was substantial variation in these intentions, because professionals disagreed with benchmarks, deemed improvement unfeasible or did not consider the indicator an essential aspect of care quality. These phenomena impede intentions to improve practice, and are thus likely to dilute the effects of audit and feedback interventions. NTR3251, pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Molecular diagnosis of bloodstream infections: planning to (physically) reach the bedside.

PubMed

Leggieri, N; Rida, A; François, P; Schrenzel, Jacques

2010-08-01

Faster identification of infecting microorganisms and treatment options is a first-ranking priority in the infectious disease area, in order to prevent inappropriate treatment and overuse of broad-spectrum antibiotics. Standard bacterial identification is intrinsically time-consuming, and very recently there has been a burst in the number of commercially available nonphenotype-based techniques and in the documentation of a possible clinical impact of these techniques. Matrix-assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOF MS) is now a standard diagnostic procedure on cultures and hold promises on spiked blood. Meanwhile, commercial PCR-based techniques have improved with the use of bacterial DNA enrichment methods, the diversity of amplicon analysis techniques (melting curve analysis, microarrays, gel electrophoresis, sequencing and analysis by mass spectrometry) leading to the ability to challenge bacterial culture as the gold standard for providing earlier diagnosis with a better 'clinical' sensitivity and additional prognostic information. Laboratory practice has already changed with MALDI-TOF MS, but a change in clinical practice, driven by emergent nucleic acid-based techniques, will need the demonstration of real-life applicability as well as robust clinical-impact-oriented studies.

Recent developments in the management of invasive fungal infections in patients with oncohematological diseases.

PubMed

Ruhnke, Markus; Schwartz, Stefan

2016-12-01

Patients with hematological cancer have a high risk of invasive fungal diseases (IFDs). These infections are mostly life threatening and an early diagnosis and initiation of appropriate antifungal therapy are essential for the clinical outcome. Most commonly, Aspergillus and Candida species are involved. However, other non- Aspergillus molds are increasingly be identified in cases of documented IFDs. Important risk factors are long lasting granulocytopenia with neutrophil counts below 500/μl for more than 10 days or graft- versus -host disease resulting from allogeneic stem-cell transplantation. For definite diagnosis of IFD, various diagnostic tools have to be applied, including conventional mycological culture and nonconventional microbiological tests such as antibody/antigen and molecular tests, as well as histopathology and radiology. In the last few years, various laboratory methods, like the Aspergillus GM immunoassay ( Aspergillus GM EIA), 1,3-ß-D-glucan (BG) assay or polymerase chain reaction (PCR) techniques have been developed for better diagnosis. Since no single indirect test, including radiological methods, provides the definite diagnosis of an invasive fungal infection, the combination of different diagnostic procedures, which include microbiological cultures, histological, serological and molecular methods like PCR together with the pattern of clinical presentation, may currently be the best strategy for the prompt diagnosis, initiation and monitoring of IFDs. Early start of antifungal therapy is mandatory, but clinical diagnostics often do not provide clear evidence of IFD. Integrated care pathways have been proposed for management and therapy of IFDs with either the diagnostic driven strategy using the preemptive antifungal therapy as opposed to the clinical or empirical driven strategy using the 'traditional' empirical antifungal therapy. Antifungal agents preferentially used for systemic therapy of invasive fungal infections are amphotericin B preparations, fluconazole, voriconazole, posaconazole, caspofungin, anidulafungin, micafungin, and most recently isavuconazole. Clinical decision making must consider licensing status, local experience and availability, pharmacological and economic aspects.

[The future of clinical laboratory database management system].

PubMed

Kambe, M; Imidy, D; Matsubara, A; Sugimoto, Y

1999-09-01

To assess the present status of the clinical laboratory database management system, the difference between the Clinical Laboratory Information System and Clinical Laboratory System was explained in this study. Although three kinds of database management systems (DBMS) were shown including the relational model, tree model and network model, the relational model was found to be the best DBMS for the clinical laboratory database based on our experience and developments of some clinical laboratory expert systems. As a future clinical laboratory database management system, the IC card system connected to an automatic chemical analyzer was proposed for personal health data management and a microscope/video system was proposed for dynamic data management of leukocytes or bacteria.

Argument-Driven Inquiry as a Way to Help Undergraduate Students Write to Learn by Learning to Write in Chemistry

ERIC Educational Resources Information Center

Sampson, Victor; Walker, Joi Phelps

2012-01-01

This exploratory study examined how undergraduate students' ability to write in science changed over time as they completed a series of laboratory activities designed using a new instructional model called argument-driven inquiry. The study was conducted in a single section of an undergraduate general chemistry lab course offered at a large…

The Development and Deployment of a Virtual Unit Operations Laboratory

ERIC Educational Resources Information Center

Vaidyanath, Sreeram; Williams, Jason; Hilliard, Marcus; Wiesner, Theodore

2007-01-01

Computer-simulated experiments offer many benefits to engineering curricula in the areas of safety, cost, and flexibility. We report our experience in developing and deploying a computer-simulated unit operations laboratory, driven by the guiding principle of maximum fidelity to the physical lab. We find that, while the up-front investment in…

Let There Be Light: Hypothesis-Driven Investigation of Ligand Effects in Photoredox Catalysis for the Undergraduate Organic Chemistry Laboratory

ERIC Educational Resources Information Center

Chen, Shuming

2018-01-01

An undergraduate organic chemistry laboratory experiment that provides an introduction to the concepts and practices of photoredox catalysis is reported. While undergraduate-level photochemistry experiments typically place emphasis on analytical properties of catalysts rather than synthetic applications, this experiment showcases the power and…

A Vodcasted, Cross-Disciplinary, Behavioral Neuroscience Laboratory Exercise Investigating the Effects of Methamphetamine on Aggression

ERIC Educational Resources Information Center

Shanks, Ryan A.; Southard, E. Megan; Tarnowski, Laura; Bruster, Matthew; Wingate, Stacia W.; Dalman, Nancy; Lloyd, Steven A.

2011-01-01

This article describes a laboratory experience utilizing videos to engage students in hypothesis-driven experimentation in behavioral neuroscience. It provides students with an opportunity to investigate the effects of chronic methamphetamine exposure on aggression in adult mice using a resident-intruder paradigm. Instructors and students only…

USING MODELS TO EXTRAPOLATE POPULATION-LEVEL EFFECTS FROM LABORATORY TOXICITY TESTS IN SUPPORT OF POPULATION RISK ASSESSMENTS

EPA Science Inventory

Using models to extrapolate population-level effects from laboratory toxicity tests in support of population risk assessments. Munns, W.R., Jr.*, Anne Kuhn, Matt G. Mitro, and Timothy R. Gleason, U.S. EPA ORD NHEERL, Narragansett, RI, USA. Driven in large part by management goa...

Making Microscopy Motivating, Memorable, & Manageable for Undergraduate Students with Digital Imaging Laboratories

ERIC Educational Resources Information Center

Weeks, Andrea; Bachman. Beverly; Josway, Sarah; North, Brittany; Tsuchiya, Mirian T.N.

2013-01-01

Microscopy and precise observation are essential skills that are challenging to teach effectively to large numbers of undergraduate biology students. We implemented student-driven digital imaging assignments for microscopy in a large enrollment laboratory for organismal biology. We detail how we promoted student engagement with the material and…

Developing translational research infrastructure and capabilities associated with cancer clinical trials.

PubMed

Hall, Jacqueline A; Brown, Robert

2013-09-27

The integration of molecular information in clinical decision making is becoming a reality. These changes are shaping the way clinical research is conducted, and as reality sets in, the challenges in conducting, managing and organising multi-disciplinary research become apparent. Clinical trials provide a platform to conduct translational research (TR) within the context of high quality clinical data accrual. Integrating TR objectives in trials allows the execution of pivotal studies that provide clinical evidence for biomarker-driven treatment strategies, targeting early drug development trials to a homogeneous and well defined patient population, supports the development of companion diagnostics and provides an opportunity for deepening our understanding of cancer biology and mechanisms of drug action. To achieve these goals within a clinical trial, developing translational research infrastructure and capabilities (TRIC) plays a critical catalytic role for translating preclinical data into successful clinical research and development. TRIC represents a technical platform, dedicated resources and access to expertise promoting high quality standards, logistical and operational support and unified streamlined procedures under an appropriate governance framework. TRIC promotes integration of multiple disciplines including biobanking, laboratory analysis, molecular data, informatics, statistical analysis and dissemination of results which are all required for successful TR projects and scientific progress. Such a supporting infrastructure is absolutely essential in order to promote high quality robust research, avoid duplication and coordinate resources. Lack of such infrastructure, we would argue, is one reason for the limited effect of TR in clinical practice beyond clinical trials.

Variant pathogenicity evaluation in the community-driven Inherited Neuropathy Variant Browser.

PubMed

Saghira, Cima; Bis, Dana M; Stanek, David; Strickland, Alleene; Herrmann, David N; Reilly, Mary M; Scherer, Steven S; Shy, Michael E; Züchner, Stephan

2018-05-01

Charcot-Marie-Tooth disease (CMT) is an umbrella term for inherited neuropathies affecting an estimated one in 2,500 people. Over 120 CMT and related genes have been identified and clinical gene panels often contain more than 100 genes. Such a large genomic space will invariantly yield variants of uncertain clinical significance (VUS) in nearly any person tested. This rise in number of VUS creates major challenges for genetic counseling. Additionally, fewer individual variants in known genes are being published as the academic merit is decreasing, and most testing now happens in clinical laboratories, which typically do not correlate their variants with clinical phenotypes. For CMT, we aim to encourage and facilitate the global capture of variant data to gain a large collection of alleles in CMT genes, ideally in conjunction with phenotypic information. The Inherited Neuropathy Variant Browser provides user-friendly open access to currently reported variation in CMT genes. Geneticists, physicians, and genetic counselors can enter variants detected by clinical tests or in research studies in addition to genetic variation gathered from published literature, which are then submitted to ClinVar biannually. Active participation of the broader CMT community will provide an advance over existing resources for interpretation of CMT genetic variation. © 2018 Wiley Periodicals, Inc.

Managing the potential and pitfalls during clinical translation of emerging stem cell therapies

PubMed Central

2014-01-01

We are moving into a new era of stem cell research where many possibilities for treatment of degenerative, chronic and/or fatal diseases and injuries are becoming primed for clinical trial. These reports have led millions of people worldwide to hope that regenerative medicine is about to revolutionise biomedicine: either through transplantation of cells grown in the laboratory, or by finding ways to stimulate a patient’s intrinsic stem cells to repair diseased and damaged organs. While major contributions of stem cells to drug discovery, safety and efficacy testing, as well as modelling ‘diseases in a dish’ are also expected, it is the in vivo use of stem cells that has captured the general public’s attention. However, public misconceptions of stem cell potential and applications can leave patients vulnerable to the influences of profit driven entities selling unproven treatments without solid scientific basis or appropriate clinical testing or follow up. This review provides a brief history of stem cell clinical translation together with an overview of the properties, potential, and current clinical application of various stem cell types. In doing so it presents a clearer picture of the inherent risks and opportunities associated with stem cell research translation, and thus offers a framework to help realise invested expectations more quickly, safely and effectively. PMID:24949190

[Laboratory accreditation and proficiency testing].

PubMed

Kuwa, Katsuhiko

2003-05-01

ISO/TC 212 covering clinical laboratory testing and in vitro diagnostic test systems will issue the international standard for medical laboratory quality and competence requirements, ISO 15189. This standard is based on the ISO/IEC 17025, general requirements for competence of testing and calibration laboratories and ISO 9001, quality management systems-requirements. Clinical laboratory services are essential to patient care and therefore should be available to meet the needs of all patients and clinical personnel responsible for human health care. If a laboratory seeks accreditation, it should select an accreditation body that operates according to this international standard and in a manner which takes into account the particular requirements of clinical laboratories. Proficiency testing should be available to evaluate the calibration laboratories and reference measurement laboratories in clinical medicine. Reference measurement procedures should be of precise and the analytical principle of measurement applied should ensure reliability. We should be prepared to establish a quality management system and proficiency testing in clinical laboratories.

Extending the Constant Power Speed Range of the Brushless DC Motor through Dual Mode Inverter Control -- Part II: Laboratory Proof-of-Principle

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lawler, J.S.

2001-10-29

Previous theoretical work has shown that when all loss mechanisms are neglected the constant power speed range (CPSR) of a brushless dc motor (BDCM) is infinite when the motor is driven by the dual-mode inverter control (DMIC) [1,2]. In a physical drive, losses, particularly speed-sensitive losses, will limit the CPSR to a finite value. In this paper we report the results of laboratory testing of a low-inductance, 7.5-hp BDCM driven by the DMIC. The speed rating of the test motor rotor limited the upper speed of the testing, and the results show that the CPSR of the test machine ismore » greater than 6:1 when driven by the DMIC. Current wave shape, peak, and rms values remained controlled and within rating over the entire speed range. The laboratory measurements allowed the speed-sensitive losses to be quantified and incorporated into computer simulation models, which then accurately reproduce the results of lab testing. The simulator shows that the limiting CPSR of the test motor is 8:1. These results confirm that the DMIC is capable of driving low-inductance BDCMs over the wide CPSR that would be required in electric vehicle applications.« less

Verification Study of Buoyancy-Driven Turbulent Nuclear Combustion

DOE Office of Scientific and Technical Information (OSTI.GOV)

None

2010-01-01

Buoyancy-driven turbulent nuclear combustion determines the rate of nuclear burning during the deflagration phase (i.e., the ordinary nuclear flame phase) of Type 1a supernovae, and hence the amount of nuclear energy released during this phase. It therefore determines the amount the white dwarf star expands prior to initiation of a detonation wave, and so the amount of radioactive nickel and thus the peak luminosity of the explosion. However, this key physical process is not fully understood. To better understand this process, the Flash Center has conducted an extensive series of large-scale 3D simulations of buoyancy-driven turbulent nuclear combustion for threemore » different physical situations. This movie shows the results for some of these simulations. Credits: Science: Ray Bair, Katherine Riley, Argonne National Laboratory; Anshu Dubey, Don Lamb, Dongwook Lee, University of Chicago; Robert Fisher, University of Massachusetts at Dartmouth and Dean Townsley, University of Alabama Visualization: Jonathan Gallagher, University of Chicago; Randy Hudson, John Norris and Michael E. Papka, Argonne National Laboratory/University of Chicago« less

Increasing medical student exposure to clinical dermatology through participation in volunteer clinics.

PubMed

Beroukhim, Kourosh; Nguyen, Catherine; Danesh, Melissa; Lee, Kristina; Liao, Wilson

2015-10-16

Over the previous decade, several innovative teaching methods have been introduced to overcome the decreasing allotment of time dedicated to dermatology in U.S. medical school curricula. We report our experience of increasing medical student exposure to clinical dermatology thorough involvement in an extracurricular, volunteer-driven dermatology clinic. The clinic was well received by students and faculty. Our experience demonstrates that volunteer-driven dermatology clinics may be an effective method of teaching and engendering a culture of community outreach among medical students and faculty.

Evidence that convergence rather than accommodation controls intermittent distance exotropia.

PubMed

Horwood, Anna M; Riddell, Patricia M

2012-03-01

This study considered whether vergence drives accommodation or accommodation drives vergence during the control of distance exotropia for near fixation. High accommodative convergence to accommodation (AC/A) ratios are often used to explain this control, but the role of convergence to drive accommodation (the CA/C relationship) is rarely considered. Atypical CA/C characteristics could equally, or better, explain common clinical findings. Nineteen distance exotropes, aged 4-11 years, were compared while controlling their deviation with 27 non-exotropic controls aged 5-9 years. Simultaneous vergence and accommodation responses were measured to a range of targets incorporating different combinations of blur, disparity and looming cues at four fixation distances between 2 m and 33 cm. Stimulus and response AC/A and CA/C ratios were calculated. Accommodation responses for near targets (p = 0.017) and response gains (p = 0.026) were greater in the exotropes than in the controls. Despite higher clinical stimulus AC/A ratios, the distance exotropes showed lower laboratory response AC/A ratios (p = 0.02), but significantly higher CA/C ratios (p = 0.02). All the exotropes, whether the angle changed most with lenses ('controlled by accommodation') or on occlusion ('controlled by fusion'), used binocular disparity not blur as their main cue to target distance. Increased vergence demand to control intermittent distance exotropia for near also drives significantly more accommodation. Minus lens therapy is more likely to act by correcting overaccommodation driven by controlling convergence, rather than by inducing blur-driven vergence. The use of convergence as a major drive to accommodation explains many clinical characteristics of distance exotropia, including apparently high near stimulus AC/A ratios. © 2012 The Authors. Acta Ophthalmologica © 2012 Acta Ophthalmologica Scandinavica Foundation.

Evidence that convergence rather than accommodation controls intermittent distance exotropia

PubMed Central

Horwood, Anna M; Riddell, Patricia M

2015-01-01

Purpose This study considered whether vergence drives accommodation or accommodation drives vergence during the control of distance exotropia for near fixation. High accommodative convergence to accommodation (AC/A) ratios are often used to explain this control, but the role of convergence to drive accommodation (the CA/C relationship) is rarely considered. Atypical CA/C characteristics could equally, or better, explain common clinical findings. Methods 19 distance exotropes, aged 4-11 years, were compared while controlling their deviation with 27 non-exotropic controls aged 5-9 years. Simultaneous vergence and accommodation responses were measured to a range of targets incorporating different combinations of blur, disparity and looming cues at four fixation distances between 2m and 33cm. Stimulus and response AC/A and CA/C ratios were calculated. Results Accommodation responses for near targets (p=0.017) response gains (p=0.026) were greater in the exotropes than the controls. Despite higher clinical stimulus AC/A ratios, the distance exotropes showed lower laboratory response AC/A ratios (p=0.02), but significantly higher CA/C ratios (p=0.02). All the exotropes, whether the angle changed most with lenses (“controlled by accommodation”) or on occlusion (“controlled by fusion”), used binocular disparity not blur as their main cue to target distance. Conclusions Increased vergence demand to control intermittent distance exotropia for near also drives significantly more accommodation. Minus lens therapy is more likely to act by correcting over-accommodation driven by controlling convergence, rather than by inducing blur-driven vergence. The use of convergence as a major drive to accommodation explains many clinical characteristics of distance exotropia, including apparently high near stimulus AC/A ratios. PMID:22280437

[Postgraduates' training as laboratory physicians/clinical pathologists in Japan--board certification of JSLM as a mandatory requirement for chairpersons of laboratory medicine].

PubMed

Kumasaka, Kazunari

2002-04-01

The educational committee of the Japanese Society of Laboratory Medicine(JSLM) proposed a revised laboratory medicine residency curriculum in 1999 and again in 2001. The committee believes that present undergraduate clinical training is insufficient and that Japanese medical graduates need clinical training for two years after graduation. This two years training should be a precondition for further postgraduate training in laboratory medicine and should include fundamental clinical skills(communication skills, physical examination and common laboratory procedures such as Gram's stain, Wright-Giemsa stain and urinalysis). After the two years training, the minimal training period of laboratory medicine should be three years, and should include: 1) Principles, instrumentation and techniques of each discipline including clinical chemistry, clinical hematology, clinical microbiology, clinical immunology, blood banking and other specific areas. 2) The use of laboratory information in a medical setting. 3) Interaction of the laboratory physician with laboratory staff, physicians and patients. With good on-the-job training and 24 hours on-call duties, laboratory physicians are expected to perform their tasks, including laboratory management, effectively. They should have appropriate educational background and should be well motivated. The background and duties of the laboratory physicians often reflect the institutional needs and personal philosophy of the chairperson of their department. At the moment, few senior physicians in Japan have qualifications in laboratory medicine and are unable, therefore, to provide the necessary guidance to help the laboratory physicians in their work. I therefore believe that the board certification of JSLM should be regarded as mandatory for chairpersons of laboratory medicine. Our on-call service system can enhance the training in laboratory medicine, and improve not only laboratory quality assurance but patients' care as well.

Home Discharge and Out-of-Hospital Follow-Up of Total Artificial Heart Patients Supported by a Portable Driver System

PubMed Central

2014-01-01

To enhance ambulation and facilitate hospital discharge of total artificial heart (TAH)–supported patients, we adapted a mobile ventricular assistance device (VAD) driver (Excor) for TAH use and report on the performance of Excor-driven TAH patients discharged home. Ten patients stabilized on a TAH, driven by the CSS (“Circulatory Support System”), were progressively switched over to the Excor in hospital over 14 days as a pilot, with daily hemodynamics and laboratory parameters measured. Twenty-two stable TAH patients were subsequently placed on the Excor, trained, and discharged home. Clinical and hemodynamic parameters were followed. All pilot study patients were clinically stable on the Excor, with no decrease in TAH output noted (6.3 + 0.3 L/min [day 1] vs. 5.8 + 0.2 L/min [day 14], p = 0.174), with a trend suggesting improvement of both hepatic and renal function. Twenty-two TAH patients were subsequently successfully discharged home on the portable driver and were supported out of hospital for up to 598 days (range, 2–598; mean = 179 ± 140 days), remaining ambulatory, New York Heart Association (NYHA) class I or II, and free of readmission for 88.5% of the time of support. TAH patients may be effectively and safely supported by a mobile drive system. As such, the utility of the TAH may be extended to support patients beyond the hospital, at home, with overall ambulatory freedom. PMID:24577369

Argument-Driven Inquiry as a Way to Help Students Learn How to Participate in Scientific Argumentation and Craft Written Arguments: An Exploratory Study

ERIC Educational Resources Information Center

Sampson, Victor; Grooms, Jonathon; Walker, Joi Phelps

2011-01-01

This exploratory study examines how a series of laboratory activities designed using a new instructional model, called Argument-Driven Inquiry (ADI), influences the ways students participate in scientific argumentation and the quality of the scientific arguments they craft as part of this process. The two outcomes of interest were assessed with a…

Mission Driven Science at Argonne

DOE Office of Scientific and Technical Information (OSTI.GOV)

Thackery, Michael; Wang, Michael; Young, Linda

2012-07-05

Mission driven science at Argonne means applying science and scientific knowledge to a physical and "real world" environment. Examples include testing a theoretical model through the use of formal science or solving a practical problem through the use of natural science. At the laboratory, our materials scientists are leading the way in producing energy solutions today that could help reduce and remove the energy crisis of tomorrow.

42 CFR 414.510 - Laboratory date of service for clinical laboratory and pathology specimens.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 3 2011-10-01 2011-10-01 false Laboratory date of service for clinical laboratory and pathology specimens. 414.510 Section 414.510 Public Health CENTERS FOR MEDICARE & MEDICAID... AND OTHER HEALTH SERVICES Payment for New Clinical Diagnostic Laboratory Tests § 414.510 Laboratory...

Novel Neoadjuvant Therapy Paradigms for Bladder Cancer: Results from the National Cancer Center Institute Forum

PubMed Central

Dinney, Colin P.N.; Hansel, Donna; McConkey, David; Shipley, William; Hagan, Michael; Dreicer, Robert; Lerner, Seth; Czerniak, Bogdan; Waldman, Fred; Groshen, Susan; True, Lawrence D.; Petricoin, Emanuel; Theodorescu, Dan; Hruszkewycz, Andrew; Bajorin, Dean

2014-01-01

Although bladder cancer (BC) is a significant health threat to the US population, integrated clinical and laboratory investigations of this disease lag behind those of other types of cancer. Advances in BC are especially challenged due in part to a general decreased level of funding over the past 5 years. It is ironic that despite the awareness that BC is the 5th most commonly diagnosed solid malignancy in the United States, and one of the most costly to treat, funding for this organ site lags far behind that of other less common malignancies. Moreover, BC offers several unique opportunities for translational research that make it an ideal candidate for investigation. One distinct advantage over other solid tumor sites is that urine and tissue are readily available for translational studies that can direct the development of novel therapy for this disease. The NCI sponsored “Novel Neoadjuvant Therapy for Bladder Cancer” forum held in brought leading clinical and laboratory-based scientists together with the advocacy community to lay the groundwork for collaborative discovery and translation. The goal of the meeting was to bridge the gaps in translational science and develop the concepts for two novel biomarker-driven clinical trials, one in the neoadjuvant presurgical setting and the other in the setting of bladder preservation with chemoradiation. The meeting provided a unique opportunity to launch a collective effort to establish molecular-based therapy for UC. Herein, we summarize the proceedings of this meeting, and the future plans resulting from this forum. PMID:25443274

Experimental Population Genetics in the Introductory Genetics Laboratory Using "Drosophila" as a Model Organism

ERIC Educational Resources Information Center

Johnson, Ronald; Kennon, Tillman

2009-01-01

Hypotheses of population genetics are derived and tested by students in the introductory genetics laboratory classroom as they explore the effects of biotic variables (physical traits of fruit flies) and abiotic variables (island size and distance) on fruit fly populations. In addition to this hypothesis-driven experiment, the development of…

Terrestrial Slugs as a Model Organism for Inquiry-Based Experimentation in a Majors General Biology Laboratory

ERIC Educational Resources Information Center

Peters, Brenda J.; Blair, Amy C.

2013-01-01

Many biology educators at the undergraduate level are revamping their laboratory curricula to incorporate inquiry-based research experiences so that students can directly participate in the process of science and improve their scientific reasoning skills. Slugs are an ideal organism for use in such a student-directed, hypothesis-driven experience.…

A Multi-mission Event-Driven Component-Based System for Support of Flight Software Development, ATLO, and Operations first used by the Mars Science Laboratory (MSL) Project

NASA Technical Reports Server (NTRS)

Dehghani, Navid; Tankenson, Michael

2006-01-01

This viewgraph presentation reviews the architectural description of the Mission Data Processing and Control System (MPCS). MPCS is an event-driven, multi-mission ground data processing components providing uplink, downlink, and data management capabilities which will support the Mars Science Laboratory (MSL) project as its first target mission. MPCS is designed with these factors (1) Enabling plug and play architecture (2) MPCS has strong inheritance from GDS components that have been developed for other Flight Projects (MER, MRO, DAWN, MSAP), and are currently being used in operations and ATLO, and (3) MPCS components are Java-based, platform independent, and are designed to consume and produce XML-formatted data

Postdoctoral Professional Fellowships in Laboratory Medicine.

PubMed

Straseski, Joely A

2013-04-01

Doctoral level scientists often pursue a traditional academic route, focusing their efforts on research and education. However, additional options exist for those that are interested in using their laboratory and research skills in a clinical setting. Clinical laboratory directors serve as the interface between the clinical laboratory and the users of laboratory test results. This article describes these career paths options for PhD scientists. Clinical laboratory directors are primarily trained via one of two routes: physicians that have been trained in clinical pathology or non-physician doctoral scientists that have completed professional fellowship training. This article will focus on the latter of these 2 routes. In the United States, completing a postdoctoral fellowship in laboratory-specific professional fields qualifies non-physician doctoral scientists as laboratory directors and consultants. Their expert consultation provides invaluable insight into testing procedures such as possible sources of interference or inaccurate test results, preferred testing for specific clinical situations, and confirmatory methods. They must also be knowledgeable about current instrumentation, assay limitations, and the newest available technologies. One of the older and more developed professional fellowships in the United States, clinical chemistry, encompasses many laboratory disciplines and will be highlighted in detail. Training information specific to clinical immunology, clinical microbiology, and clinical genetics is also discussed.

42 CFR 493.2001 - Establishment and function of the Clinical Laboratory Improvement Advisory Committee.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Establishment and function of the Clinical... LABORATORY REQUIREMENTS Consultations § 493.2001 Establishment and function of the Clinical Laboratory Improvement Advisory Committee. (a) HHS will establish a Clinical Laboratory Improvement Advisory Committee to...

42 CFR 405.515 - Reimbursement for clinical laboratory services billed by physicians.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 2 2010-10-01 2010-10-01 false Reimbursement for clinical laboratory services... Criteria for Determining Reasonable Charges § 405.515 Reimbursement for clinical laboratory services billed... limitation on reimbursement for markups on clinical laboratory services billed by physicians. If a physician...

76 FR 22711 - Announcement of the Re-Approval of the American Society of Histocompatibility and Immunogenetics...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-22

... Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988 AGENCY: Centers for... accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of... Authority On October 31, 1988, the Congress enacted the Clinical Laboratory Improvement Amendments of 1988...

Survey of Clinical Laboratory Practices for 2015 Middle East Respiratory Syndrome Coronavirus Outbreak in the Republic of Korea.

PubMed

Lee, Mi-Kyung; Kim, Sinyoung; Kim, Mi-Na; Kweon, Oh Joo; Lim, Yong Kwan; Ki, Chang-Seok; Kim, Jae-Seok; Seong, Moon-Woo; Sung, Heungsup; Yong, Dongeun; Lee, Hyukmin; Choi, Jong-Rak; Kim, Jeong-Ho

2016-03-01

It is crucial to understand the current status of clinical laboratory practices for the largest outbreak of Middle East respiratory syndrome coronavirus (MERS-CoV) infections in the Republic of Korea to be well prepared for future emerging infectious diseases. We conducted a survey of 49 clinical laboratories in medical institutions and referral medical laboratories. A short questionnaire to survey clinical laboratory practices relating to MERS-CoV diagnostic testing was sent by email to the directors and clinical pathologists in charge of the clinical laboratories performing MERS-CoV testing. The survey focused on testing volume, reporting of results, resources, and laboratory safety. A total of 40 clinical laboratories responded to the survey. A total of 27,009 MERS-CoV real-time reverse transcription PCR (rRT-PCR) tests were performed. Most of the specimens were sputum (73.5%). The median turnaround time (TAT) was 5.29 hr (first and third quartile, 4.11 and 7.48 hr) in 26 medical institutions. The median TAT of more than a half of the laboratories (57.7%) was less than 6 hr. Many laboratories were able to perform tests throughout the whole week. Laboratory biosafety preparedness included class II biosafety cabinets (100%); separated pre-PCR, PCR, and post-PCR rooms (88.6%); negative pressure pretreatment rooms (48.6%); and negative pressure sputum collection rooms (20.0%). Clinical laboratories were able to quickly expand their diagnostic capacity in response to the 2015 MERS-CoV outbreak. Our results show that clinical laboratories play an important role in the maintenance and enhancement of laboratory response in preparation for future emerging infections.

Survey of Clinical Laboratory Practices for 2015 Middle East Respiratory Syndrome Coronavirus Outbreak in the Republic of Korea

PubMed Central

Lee, Mi-Kyung; Kim, Sinyoung; Kim, Mi-Na; Kweon, Oh Joo; Lim, Yong Kwan; Ki, Chang-Seok; Kim, Jae-Seok; Seong, Moon-Woo; Sung, Heungsup; Yong, Dongeun; Lee, Hyukmin; Choi, Jong-Rak

2016-01-01

Background It is crucial to understand the current status of clinical laboratory practices for the largest outbreak of Middle East respiratory syndrome coronavirus (MERS-CoV) infections in the Republic of Korea to be well prepared for future emerging infectious diseases. Methods We conducted a survey of 49 clinical laboratories in medical institutions and referral medical laboratories. A short questionnaire to survey clinical laboratory practices relating to MERS-CoV diagnostic testing was sent by email to the directors and clinical pathologists in charge of the clinical laboratories performing MERS-CoV testing. The survey focused on testing volume, reporting of results, resources, and laboratory safety. Results A total of 40 clinical laboratories responded to the survey. A total of 27,009 MERS-CoV real-time reverse transcription PCR (rRT-PCR) tests were performed. Most of the specimens were sputum (73.5%). The median turnaround time (TAT) was 5.29 hr (first and third quartile, 4.11 and 7.48 hr) in 26 medical institutions. The median TAT of more than a half of the laboratories (57.7%) was less than 6 hr. Many laboratories were able to perform tests throughout the whole week. Laboratory biosafety preparedness included class II biosafety cabinets (100%); separated pre-PCR, PCR, and post-PCR rooms (88.6%); negative pressure pretreatment rooms (48.6%); and negative pressure sputum collection rooms (20.0%). Conclusions Clinical laboratories were able to quickly expand their diagnostic capacity in response to the 2015 MERS-CoV outbreak. Our results show that clinical laboratories play an important role in the maintenance and enhancement of laboratory response in preparation for future emerging infections. PMID:26709263

Beta-lactam resistance in the gram negatives: increasing complexity of conditional, composite and multiply resistant phenotypes.

PubMed

Iredell, Jon; Thomas, Lee; Espedido, Björn

2006-12-01

The greatest impact of microbiology data on clinical care is in the critically ill. Unfortunately, this is also the area in which microbiology laboratories are most often non-contributive. Attempts to move to rapid, culture-independent diagnostics are driven by the need to expedite urgent results. This is difficult in Gram-negative infection because of the complexity of the antibiotic resistance phenotype. Here, we discuss resistance to modern beta-lactams as a case in point. Recent outbreaks of transmissible carbapenem resistance among Gram-negative enteric pathogens in Sydney and Melbourne serve to illustrate the pitfalls of traditional phenotypical approaches. A better understanding of the epidemiology and mosaic nature of antibiotic resistance elements in the microflora is needed for us to move forward.

Postdoctoral Fellow | Center for Cancer Research

Cancer.gov

The Neuro-Oncology Branch (NOB), Center for Cancer Research (CCR), National Cancer Institute (NCI) of the National Institutes of Health (NIH) is seeking outstanding postdoctoral candidates interested in studying metabolic and cell signaling pathways in the context of brain cancers through construction of computational models amenable to formal computational analysis and simulation. The ability to closely collaborate with the modern metabolomics center developed at CCR provides a unique opportunity for a postdoctoral candidate with a strong theoretical background and interest in demonstrating the incredible potential of computational approaches to solve problems from scientific disciplines and improve lives. The candidate will be given the opportunity to both construct data-driven models, as well as biologically validate the models by demonstrating the ability to predict the effects of altering tumor metabolism in laboratory and clinical settings.

IAEA support to medical physics in nuclear medicine.

PubMed

Meghzifene, Ahmed; Sgouros, George

2013-05-01

Through its programmatic efforts and its publications, the International Atomic Energy Agency (IAEA) has helped define the role and responsibilities of the nuclear medicine physicist in the practice of nuclear medicine. This paper describes the initiatives that the IAEA has undertaken to support medical physics in nuclear medicine. In 1984, the IAEA provided guidance on how to ensure that the equipment used for detecting, imaging, and quantifying radioactivity is functioning properly (Technical Document [TECDOC]-137, "Quality Control of Nuclear Medicine Instruments"). An updated version of IAEA-TECDOC-137 was issued in 1991 as IAEA-TECDOC-602, and this included new chapters on scanner-computer systems and single-photon emission computed tomography systems. Nuclear medicine physics was introduced as a part of a project on radiation imaging and radioactivity measurements in the 2002-2003 IAEA biennium program in Dosimetry and Medical Radiation Physics. Ten years later, IAEA activities in this field have expanded to cover quality assurance (QA) and quality control (QC) of nuclear medicine equipment, education and clinical training, professional recognition of the role of medical physicists in nuclear medicine physics, and finally, the coordination of research and development activities in internal dosimetry. As a result of these activities, the IAEA has received numerous requests to support the development and implementation of QA or QC programs for radioactivity measurements in nuclear medicine in many Member States. During the last 5 years, support was provided to 20 Member States through the IAEA's technical cooperation programme. The IAEA has also supported education and clinical training of medical physicists. This type of support has been essential for the development and expansion of the Medical Physics profession, especially in low- and middle-income countries. The need for basic as well as specialized clinical training in medical physics was identified as a priority for healthcare providers in many countries. The IAEA's response to meet the increasing needs for training has been 2-folds. Through its regular program, a priority is given to the development of standardized syllabi and education and clinical training guides. Through its technical cooperation programme, support is given for setting up national medical physics education and clinical training programs in countries. In addition, fellowships are granted for professionals working in the field for specialized training, and workshops are organized at the national and regional level in specialized topics of nuclear medicine physics. So as to support on-the-job training, the IAEA has also setup a gamma camera laboratory in Seibersdorf, Austria. The laboratory is also equipped with QC tools and equipments, and radioisotopes are procured when training events are held. About 2-3 specialized courses are held every year for medical physicists at the IAEA gamma camera laboratory. In the area of research and development, the IAEA supports, through its coordinated research projects, new initiatives in quantitative nuclear medicine and internal dosimetry. The future of nuclear medicine is driven by advances in instrumentation, by the ever increasing availability of computing power and data storage, and by the development of new radiopharmaceuticals for molecular imaging and therapy. Future developments in nuclear medicine are partially driven by, and will influence, nuclear medicine physics and medical physics. To summarize, the IAEA has established a number of programs to support nuclear medicine physics and will continue to do so through its coordinated research activities, education and training in clinical medical physics, and through programs and meetings to promote standardization and harmonization of QA or QC procedures for imaging and treatment of patients. Copyright © 2013 Elsevier Inc. All rights reserved.

Clinical exposures during internal medicine acting internship: profiling student and team experiences.

PubMed

Smith, Todd I; LoPresti, Charles M

2014-07-01

The clinical learning model in medical education is driven by knowledge acquisition through direct patient-care experiences. Despite the emphasis on experiential learning, the ability of educators to quantify the clinical exposures of learners is limited. To utilize Veterans Affairs (VA) electronic medical record information through a data warehouse to quantify clinical exposures during an inpatient internal medicine rotation. We queried the VA clinical data warehouse for the patients encountered by each learner completing an acting internship rotation at the Cleveland VA Medical Center from July 2008 to November 2011. We then used discharge summary information to identify team exposures-patients seen by the learner's inpatient team who were not primarily assigned to the learner. Based on the learner and team exposures, we complied lists of past medical problems, medications prescribed, laboratory tests that resulted, radiology evaluated, and primary discharge diagnoses. Primary learner and team-based clinical exposures were evaluated for a total of 128 acting internship students. The percentage of learners who had a primary exposure to a medication/lab value/imaging result/diagnosis was calculated. The percentage of learners with at least 1 primary or team-based exposure to an item was also calculated. The most common exposures in each category are presented. Analysis of the clinical exposures during an inpatient rotation can augment the ability of educators to understand learners' experiences. These types of analyses could provide information to improve learner experience, implement novel curricula, and address educational gaps in clinical rotations. © 2014 Society of Hospital Medicine.

Stakeholder-Driven Quality Improvement: A Compelling Force for Clinical Practice Guidelines.

PubMed

Rosenfeld, Richard M; Wyer, Peter C

2018-01-01

Clinical practice guideline development should be driven by rigorous methodology, but what is less clear is where quality improvement enters the process: should it be a priority-guiding force, or should it enter only after recommendations are formulated? We argue for a stakeholder-driven approach to guideline development, with an overriding goal of quality improvement based on stakeholder perceptions of needs, uncertainties, and knowledge gaps. In contrast, the widely used topic-driven approach, which often makes recommendations based only on randomized controlled trials, is driven by epidemiologic purity and evidence rigor, with quality improvement a downstream consideration. The advantages of a stakeholder-driven versus a topic-driven approach are highlighted by comparisons of guidelines for otitis media with effusion, thyroid nodules, sepsis, and acute bacterial rhinosinusitis. These comparisons show that stakeholder-driven guidelines are more likely to address the quality improvement needs and pressing concerns of clinicians and patients, including understudied populations and patients with multiple chronic conditions. Conversely, a topic-driven approach often addresses "typical" patients, based on research that may not reflect the needs of high-risk groups excluded from studies because of ethical issues or a desire for purity of research design.

Generation and Evolution of High-Mach-Number Laser-Driven Magnetized Collisionless Shocks in the Laboratory

DOE PAGES

Schaeffer, D. B.; Fox, W.; Haberberger, D.; ...

2017-07-13

Here, we present the first laboratory generation of high-Mach-number magnetized collisionless shocks created through the interaction of an expanding laser-driven plasma with a magnetized ambient plasma. Time-resolved, two-dimensional imaging of plasma density and magnetic fields shows the formation and evolution of a supercritical shock propagating at magnetosonic Mach number M ms ≈ 12. Particle-in-cell simulations constrained by experimental data further detail the shock formation and separate dynamics of the multi-ion-species ambient plasma. The results show that the shocks form on time scales as fast as one gyroperiod, aided by the efficient coupling of energy, and the generation of a magneticmore » barrier between the piston and ambient ions. The development of this experimental platform complements present remote sensing and spacecraft observations, and opens the way for controlled laboratory investigations of high-Mach number collisionless shocks, including the mechanisms and efficiency of particle acceleration.« less

Generation and Evolution of High-Mach-Number Laser-Driven Magnetized Collisionless Shocks in the Laboratory

DOE Office of Scientific and Technical Information (OSTI.GOV)

Schaeffer, D. B.; Fox, W.; Haberberger, D.

Here, we present the first laboratory generation of high-Mach-number magnetized collisionless shocks created through the interaction of an expanding laser-driven plasma with a magnetized ambient plasma. Time-resolved, two-dimensional imaging of plasma density and magnetic fields shows the formation and evolution of a supercritical shock propagating at magnetosonic Mach number M ms ≈ 12. Particle-in-cell simulations constrained by experimental data further detail the shock formation and separate dynamics of the multi-ion-species ambient plasma. The results show that the shocks form on time scales as fast as one gyroperiod, aided by the efficient coupling of energy, and the generation of a magneticmore » barrier between the piston and ambient ions. The development of this experimental platform complements present remote sensing and spacecraft observations, and opens the way for controlled laboratory investigations of high-Mach number collisionless shocks, including the mechanisms and efficiency of particle acceleration.« less

[How do hospital clinical laboratories and laboratory testing companies cooperate and build reciprocal relations?].

PubMed

Kawano, Seiji

2014-12-01

As the 2nd Joint Symposium of the Japanese Society of Laboratory Medicine and the Japanese Association of Laboratory Pathologists, the symposium on clinical test out-sourcing and branch laboratories was held at the 60th General Meeting of the Japanese Society of Laboratory Medicine on November 2nd, 2013 in Kobe. For the symposium, we conducted a questionnaire survey on the usage of clinical test out-sourcing and the introduction of branch laboratories to clinical laboratories of Japanese university hospitals, both private and public, between July 25th and August 20th, 2013. Seventy-two hospitals responded to the questionnaire survey, consisting of 41 public medical school hospitals and 31 private ones. According to the survey, the selection of each clinical test for out-sourcing was mainly determined by the capacities of hospital clinical laboratories and their equipment, as well as the profitability of each test. The main concerns of clinical laboratory members of university hospitals involved the continuity of measurement principles, traceability, and standardization of reference values for each test. They strongly requested the interchangeability and computerization of test data between laboratory testing companies. A branch laboratory was introduced to six hospitals, all of which were private medical college hospitals, out of 72 university hospitals, and eight of the other hospitals were open to its introduction. The merits and demerits of introducing a branch laboratory were also discussed. (Review).

Service quality framework for clinical laboratories.

PubMed

Ramessur, Vinaysing; Hurreeram, Dinesh Kumar; Maistry, Kaylasson

2015-01-01

The purpose of this paper is to illustrate a service quality framework that enhances service delivery in clinical laboratories by gauging medical practitioner satisfaction and by providing avenues for continuous improvement. The case study method has been used for conducting the exploratory study, with focus on the Mauritian public clinical laboratory. A structured questionnaire based on the SERVQUAL service quality model was used for data collection, analysis and for the development of the service quality framework. The study confirms the pertinence of the following service quality dimensions within the context of clinical laboratories: tangibility, reliability, responsiveness, turnaround time, technology, test reports, communication and laboratory staff attitude and behaviour. The service quality framework developed, termed LabSERV, is vital for clinical laboratories in the search for improving service delivery to medical practitioners. This is a pioneering work carried out in the clinical laboratory sector in Mauritius. Medical practitioner expectations and perceptions have been simultaneously considered to generate a novel service quality framework for clinical laboratories.

[Laboratory medicine in the obligatory postgraduate clinical training system--common clinical training program in the department of laboratory medicine in our prefectural medical university hospital].

PubMed

Okamoto, Yasuyuki

2003-04-01

I propose a postgraduate common clinical training program to be provided by the department of laboratory medicine in our prefectural medical university hospital. The program has three purposes: first, mastering basic laboratory tests; second, developing the skills necessary to accurately interpret laboratory data; third, learning specific techniques in the field of laboratory medicine. For the first purpose, it is important that medical trainees perform testing of their own patients at bedside or in the central clinical laboratory. When testing at the central clinical laboratory, instruction by expert laboratory technicians is helpful. The teaching doctors in the department of laboratory medicine are asked to advise the trainees on the interpretation of data. Consultation will be received via interview or e-mail. In addition, the trainees can participate in various conferences, seminars, and meetings held at the central clinical laboratory. Finally, in order to learn specific techniques in the field of laboratory medicine, several special courses lasting a few months will be prepared. I think this program should be closely linked to the training program in internal medicine.

42 CFR 414.506 - Procedures for public consultation for payment for a new clinical diagnostic laboratory test.

Code of Federal Regulations, 2010 CFR

2010-10-01

... a new clinical diagnostic laboratory test. 414.506 Section 414.506 Public Health CENTERS FOR... FOR PART B MEDICAL AND OTHER HEALTH SERVICES Payment for New Clinical Diagnostic Laboratory Tests § 414.506 Procedures for public consultation for payment for a new clinical diagnostic laboratory test...

10 CFR 32.71 - Manufacture and distribution of byproduct material for certain in vitro clinical or laboratory...

Code of Federal Regulations, 2010 CFR

2010-01-01

... certain in vitro clinical or laboratory testing under general license. 32.71 Section 32.71 Energy NUCLEAR... certain in vitro clinical or laboratory testing under general license. An application for a specific... only by physicians, veterinarians in the practice of veterinary medicine, clinical laboratories or...

42 CFR 414.506 - Procedures for public consultation for payment for a new clinical diagnostic laboratory test.

Code of Federal Regulations, 2011 CFR

2011-10-01

... a new clinical diagnostic laboratory test. 414.506 Section 414.506 Public Health CENTERS FOR... FOR PART B MEDICAL AND OTHER HEALTH SERVICES Payment for New Clinical Diagnostic Laboratory Tests § 414.506 Procedures for public consultation for payment for a new clinical diagnostic laboratory test...

A decade of experience in the development and implementation of tissue banking informatics tools for intra and inter-institutional translational research

PubMed Central

Amin, Waqas; Singh, Harpreet; Pople, Andre K.; Winters, Sharon; Dhir, Rajiv; Parwani, Anil V.; Becich, Michael J.

2010-01-01

Context: Tissue banking informatics deals with standardized annotation, collection and storage of biospecimens that can further be shared by researchers. Over the last decade, the Department of Biomedical Informatics (DBMI) at the University of Pittsburgh has developed various tissue banking informatics tools to expedite translational medicine research. In this review, we describe the technical approach and capabilities of these models. Design: Clinical annotation of biospecimens requires data retrieval from various clinical information systems and the de-identification of the data by an honest broker. Based upon these requirements, DBMI, with its collaborators, has developed both Oracle-based organ-specific data marts and a more generic, model-driven architecture for biorepositories. The organ-specific models are developed utilizing Oracle 9.2.0.1 server tools and software applications and the model-driven architecture is implemented in a J2EE framework. Result: The organ-specific biorepositories implemented by DBMI include the Cooperative Prostate Cancer Tissue Resource (http://www.cpctr.info/), Pennsylvania Cancer Alliance Bioinformatics Consortium (http://pcabc.upmc.edu/main.cfm), EDRN Colorectal and Pancreatic Neoplasm Database (http://edrn.nci.nih.gov/) and Specialized Programs of Research Excellence (SPORE) Head and Neck Neoplasm Database (http://spores.nci.nih.gov/current/hn/index.htm). The model-based architecture is represented by the National Mesothelioma Virtual Bank (http://mesotissue.org/). These biorepositories provide thousands of well annotated biospecimens for the researchers that are searchable through query interfaces available via the Internet. Conclusion: These systems, developed and supported by our institute, serve to form a common platform for cancer research to accelerate progress in clinical and translational research. In addition, they provide a tangible infrastructure and resource for exposing research resources and biospecimen services in collaboration with the clinical anatomic pathology laboratory information system (APLIS) and the cancer registry information systems. PMID:20922029

A decade of experience in the development and implementation of tissue banking informatics tools for intra and inter-institutional translational research.

PubMed

Amin, Waqas; Singh, Harpreet; Pople, Andre K; Winters, Sharon; Dhir, Rajiv; Parwani, Anil V; Becich, Michael J

2010-08-10

Tissue banking informatics deals with standardized annotation, collection and storage of biospecimens that can further be shared by researchers. Over the last decade, the Department of Biomedical Informatics (DBMI) at the University of Pittsburgh has developed various tissue banking informatics tools to expedite translational medicine research. In this review, we describe the technical approach and capabilities of these models. Clinical annotation of biospecimens requires data retrieval from various clinical information systems and the de-identification of the data by an honest broker. Based upon these requirements, DBMI, with its collaborators, has developed both Oracle-based organ-specific data marts and a more generic, model-driven architecture for biorepositories. The organ-specific models are developed utilizing Oracle 9.2.0.1 server tools and software applications and the model-driven architecture is implemented in a J2EE framework. The organ-specific biorepositories implemented by DBMI include the Cooperative Prostate Cancer Tissue Resource (http://www.cpctr.info/), Pennsylvania Cancer Alliance Bioinformatics Consortium (http://pcabc.upmc.edu/main.cfm), EDRN Colorectal and Pancreatic Neoplasm Database (http://edrn.nci.nih.gov/) and Specialized Programs of Research Excellence (SPORE) Head and Neck Neoplasm Database (http://spores.nci.nih.gov/current/hn/index.htm). The model-based architecture is represented by the National Mesothelioma Virtual Bank (http://mesotissue.org/). These biorepositories provide thousands of well annotated biospecimens for the researchers that are searchable through query interfaces available via the Internet. These systems, developed and supported by our institute, serve to form a common platform for cancer research to accelerate progress in clinical and translational research. In addition, they provide a tangible infrastructure and resource for exposing research resources and biospecimen services in collaboration with the clinical anatomic pathology laboratory information system (APLIS) and the cancer registry information systems.

Magnetically driven oscillator and resonance: a teaching tool

NASA Astrophysics Data System (ADS)

Erol, M.; Çolak, İ. Ö.

2018-05-01

This paper reports a simple magnetically driven oscillator, designed and resolved in order to achieve a better student understanding and to overcome certain instructional difficulties. The apparatus is mainly comprised of an ordinary spring pendulum with a neodymium magnet attached to the bottom, a coil placed in the same vertical direction, an ordinary function generator, an oscilloscope and a smartphone. Driven oscillation and resonance is basically managed by applying a sinusoidal voltage to the coil and tuning the driving frequency to the natural frequency of the pendulum. The resultant oscillation is recorded by a smartphone video application and analyzed via a video analysis programme. The designed apparatus can easily be employed in basic physics laboratories to achieve an enhanced and deeper understanding of driven oscillation and resonance.

42 CFR 414.510 - Laboratory date of service for clinical laboratory and pathology specimens.

Code of Federal Regulations, 2014 CFR

2014-10-01

... and pathology specimens. 414.510 Section 414.510 Public Health CENTERS FOR MEDICARE & MEDICAID... Laboratory date of service for clinical laboratory and pathology specimens. The date of service for either a clinical laboratory test or the technical component of physician pathology service is as follows: (a...

42 CFR 414.510 - Laboratory date of service for clinical laboratory and pathology specimens.

Code of Federal Regulations, 2012 CFR

2012-10-01

... and pathology specimens. 414.510 Section 414.510 Public Health CENTERS FOR MEDICARE & MEDICAID... Laboratory date of service for clinical laboratory and pathology specimens. The date of service for either a clinical laboratory test or the technical component of physician pathology service is as follows: (a...

42 CFR 414.510 - Laboratory date of service for clinical laboratory and pathology specimens.

Code of Federal Regulations, 2013 CFR

2013-10-01

... and pathology specimens. 414.510 Section 414.510 Public Health CENTERS FOR MEDICARE & MEDICAID... Laboratory date of service for clinical laboratory and pathology specimens. The date of service for either a clinical laboratory test or the technical component of physician pathology service is as follows: (a...

The Question-Driven Laboratory Exercise: A New Pedagogy Applied to a Green Modification of Grignard Reagent Formation and Reaction

ERIC Educational Resources Information Center

Teixeira, Jennifer M.; Byers, Jessie Nedrow; Perez, Marilu G.; Holman, R. W.

2010-01-01

Experimental exercises within second-year-level organic laboratory manuals typically involve a statement of a principle that is then validated by student generation of data in a single experiment. These experiments are structured in the exact opposite order of the scientific method, in which data interpretation, typically from multiple related…

Basket Studies: Redefining Clinical Trials in the Era of Genome-Driven Oncology.

PubMed

Tao, Jessica J; Schram, Alison M; Hyman, David M

2018-01-29

Understanding a tumor's detailed molecular profile has become increasingly necessary to deliver the standard of care for patients with advanced cancer. Innovations in both tumor genomic sequencing technology and the development of drugs that target molecular alterations have fueled recent gains in genome-driven oncology care. "Basket studies," or histology-agnostic clinical trials in genomically selected patients, represent one important research tool to continue making progress in this field. We review key aspects of genome-driven oncology care, including the purpose and utility of basket studies, biostatistical considerations in trial design, genomic knowledgebase development, and patient matching and enrollment models, which are critical for translating our genomic knowledge into clinically meaningful outcomes.

An integrated, ethically driven environmental model of clinical decision making in emergency settings.

PubMed

Wolf, Lisa

2013-02-01

To explore the relationship between multiple variables within a model of critical thinking and moral reasoning. A quantitative descriptive correlational design using a purposive sample of 200 emergency nurses. Measured variables were accuracy in clinical decision-making, moral reasoning, perceived care environment, and demographics. Analysis was by bivariate correlation using Pearson's product-moment correlation coefficients, chi square and multiple linear regression analysis. The elements as identified in the integrated ethically-driven environmental model of clinical decision-making (IEDEM-CD) corrected depict moral reasoning and environment of care as factors significantly affecting accuracy in decision-making. The integrated, ethically driven environmental model of clinical decision making is a framework useful for predicting clinical decision making accuracy for emergency nurses in practice, with further implications in education, research and policy. A diagnostic and therapeutic framework for identifying and remediating individual and environmental challenges to accurate clinical decision making. © 2012, The Author. International Journal of Nursing Knowledge © 2012, NANDA International.

42 CFR 414.509 - Reconsideration of basis for and amount of payment for a new clinical diagnostic laboratory test.

Code of Federal Regulations, 2010 CFR

2010-10-01

... for a new clinical diagnostic laboratory test. 414.509 Section 414.509 Public Health CENTERS FOR... FOR PART B MEDICAL AND OTHER HEALTH SERVICES Payment for New Clinical Diagnostic Laboratory Tests § 414.509 Reconsideration of basis for and amount of payment for a new clinical diagnostic laboratory...

10 CFR 31.11 - General license for use of byproduct material for certain in vitro clinical or laboratory testing.

Code of Federal Regulations, 2010 CFR

2010-01-01

... in vitro clinical or laboratory testing. 31.11 Section 31.11 Energy NUCLEAR REGULATORY COMMISSION... certain in vitro clinical or laboratory testing. (a) A general license is hereby issued to any physician, veterinarian in the practice of veterinary medicine, clinical laboratory or hospital to receive, acquire...

Teaching method validation in the clinical laboratory science curriculum.

PubMed

Moon, Tara C; Legrys, Vicky A

2008-01-01

With the Clinical Laboratory Improvement Amendment's (CLIA) final rule, the ability of the Clinical Laboratory Scientist (CLS) to perform method validation has become increasingly important. Knowledge of the statistical methods and procedures used in method validation is imperative for clinical laboratory scientists. However, incorporating these concepts in a CLS curriculum can be challenging, especially at a time of limited resources. This paper provides an outline of one approach to addressing these topics in lecture courses and integrating them in the student laboratory and the clinical practicum for direct application.

Gaining Insights from Candida Biofilm Heterogeneity: One Size Does Not Fit All

PubMed Central

Kean, Ryan; Delaney, Christopher; Rajendran, Ranjith; Sherry, Leighann; Metcalfe, Rebecca; Thomas, Rachael; McLean, William; Williams, Craig; Ramage, Gordon

2018-01-01

Despite their clinical significance and substantial human health burden, fungal infections remain relatively under-appreciated. The widespread overuse of antibiotics and the increasing requirement for indwelling medical devices provides an opportunistic potential for the overgrowth and colonization of pathogenic Candida species on both biological and inert substrates. Indeed, it is now widely recognized that biofilms are a highly important part of their virulence repertoire. Candida albicans is regarded as the primary fungal biofilm forming species, yet there is also increasing interest and growing body of evidence for non-Candida albicans species (NCAS) biofilms, and interkingdom biofilm interactions. C. albicans biofilms are heterogeneous structures by definition, existing as three-dimensional populations of yeast, pseudo-hyphae, and hyphae, embedded within a self-produced extracellular matrix. Classical molecular approaches, driven by extensive studies of laboratory strains and mutants, have enhanced our knowledge and understanding of how these complex communities develop, thrive, and cause host-mediated damage. Yet our clinical observations tell a different story, with differential patient responses potentially due to inherent biological heterogeneity from specific clinical isolates associated with their infections. This review explores some of the recent advances made in an attempt to explore the importance of working with clinical isolates, and what this has taught us. PMID:29371505

42 CFR 493.1453 - Condition: Laboratories performing high complexity testing; clinical consultant.

Code of Federal Regulations, 2010 CFR

2010-10-01

... testing; clinical consultant. 493.1453 Section 493.1453 Public Health CENTERS FOR MEDICARE & MEDICAID... Condition: Laboratories performing high complexity testing; clinical consultant. The laboratory must have a clinical consultant who meets the requirements of § 493.1455 of this subpart and provides clinical...

Creep Laboratory manual

NASA Astrophysics Data System (ADS)

Osgerby, S.; Loveday, M. S.

1992-06-01

A manual for the NPL Creep Laboratory, a collective name given to two testing laboratories, the Uniaxial Creep Laboratory and the Advanced High Temperature Mechanical Testing Laboratory, is presented. The first laboratory is devoted to uniaxial creep testing and houses approximately 50 high sensitivity creep machines including 10 constant stress cam lever machines. The second laboratory houses a low cycle fatigue testing machine of 100 kN capacity driven by a servo-electric actuator, five machines for uniaxial tensile creep testing of engineering ceramics at temperatures up to 1600C, and an electronic creep machine. Details of the operational procedures for carrying out uniaxial creep testing are given. Calibration procedures to be followed in order to comply with the specifications laid down by British standards, and to provide traceability back to the primary standards are described.

Professional behaviors, sense of belonging, and professional socialization of early career clinical laboratory scientists

NASA Astrophysics Data System (ADS)

Schill, Janna Marie

Professional socialization is a process that individuals experience as members of a profession and consists of the knowledge, attitudes, and experiences that influence and shape their professional identity. The process of professional socialization has not been studied in the clinical laboratory science profession. Clinical laboratory science is an allied health profession that is faced by a workforce shortage that has been caused by a decrease in new graduates, decreased retention of qualified professionals, and increased retirements. Other allied health professions such as nursing, athletic training, and pharmacy have studied professional socialization as a way to identify factors that may influence the retention of early career professionals. This mixed method study, which quantitatively used Hall's Professionalism Scale (1968) in addition to qualitative focus group interviews, sought to identify the professional attitudes and behaviors, sense of belonging, and professional socialization of early career clinical laboratory scientists. Early career clinical laboratory scientists were divided into two groups based upon the amount of work experience they had; new clinical laboratory science graduates have had less than one year of work experience and novice clinical laboratory scientists had between one and three years of work experience. This study found that early career clinical laboratory scientists have established professional identities and view themselves as members of the clinical laboratory science field within four proposed stages of professional socialization consisting of pre-arrival, encounter, adaptation, and commitment. New CLS graduates and novice clinical laboratory scientists were found to be at different stages of the professional stage process. New CLS graduates, who had less than one year of work experience, were found to be in the encounter stage. Novice clinical laboratory scientists, with one to three years of work experience, were found to be in the adaptation stage. In order for early career clinical laboratory scientists to successfully transition from student to committed professional, increased support from more experienced colleagues needs to be provided for this group of laboratory professionals. This study provided an initial examination of the professional socialization process in the CLS profession and adds to existing professional socialization studies in allied health.

A laboratory medicine residency training program that includes clinical consultation and research.

PubMed

Spitzer, E D; Pierce, G F; McDonald, J M

1990-04-01

We describe a laboratory medicine residency training program that includes ongoing interaction with both clinical laboratories and clinical services as well as significant research experience. Laboratory medicine residents serve as on-call consultants in the interpretation of test results, design of testing strategies, and assurance of test quality. The consultative on-call beeper system was evaluated and is presented as an effective method of clinical pathology training that is well accepted by the clinical staff. The research component of the residency program is also described. Together, these components provide training in real-time clinical problem solving and prepare residents for the changing technological environment of the clinical laboratory. At the completion of the residency, the majority of the residents are qualified laboratory subspecialists and are also capable of running an independent research program.

Physical dimensions, torsional performance, bending properties, and metallurgical characteristics of rotary endodontic instruments. VI. Canal Master drills.

PubMed

Luebke, N H; Brantley, W A; Sabri, Z I; Luebke, F L; Lausten, L L

1995-05-01

A laboratory study was performed on machine-driven Canal Master drills to determine their physical dimensions, torsional performance, bending properties, and metallurgical characteristics in fracture. Physical dimensions were determined for each of the available sizes (#50 to #100) of Canal Master drills from the manufacturer that distributes these instruments in the United States. Samples were also tested in clockwise torsion using a Maillefer memocouple. Bending properties of cantilever specimens were measured with a Tinius Olsen stiffness tester. Bending fatigue testing was performed on a unique laboratory apparatus. Scanning electron microscope examination confirmed visual observations that the stainless steel Canal Master drills exhibited ductile torsional fracture. This study is part of a continuing investigation to establish standards for all machine-driven rotary endodontic instruments.

Centrifugal LabTube platform for fully automated DNA purification and LAMP amplification based on an integrated, low-cost heating system.

PubMed

Hoehl, Melanie M; Weißert, Michael; Dannenberg, Arne; Nesch, Thomas; Paust, Nils; von Stetten, Felix; Zengerle, Roland; Slocum, Alexander H; Steigert, Juergen

2014-06-01

This paper introduces a disposable battery-driven heating system for loop-mediated isothermal DNA amplification (LAMP) inside a centrifugally-driven DNA purification platform (LabTube). We demonstrate LabTube-based fully automated DNA purification of as low as 100 cell-equivalents of verotoxin-producing Escherichia coli (VTEC) in water, milk and apple juice in a laboratory centrifuge, followed by integrated and automated LAMP amplification with a reduction of hands-on time from 45 to 1 min. The heating system consists of two parallel SMD thick film resistors and a NTC as heating and temperature sensing elements. They are driven by a 3 V battery and controlled by a microcontroller. The LAMP reagents are stored in the elution chamber and the amplification starts immediately after the eluate is purged into the chamber. The LabTube, including a microcontroller-based heating system, demonstrates contamination-free and automated sample-to-answer nucleic acid testing within a laboratory centrifuge. The heating system can be easily parallelized within one LabTube and it is deployable for a variety of heating and electrical applications.

Modeling pressure-driven assembly of polymer coated nanoparticles

NASA Astrophysics Data System (ADS)

Lane, J. Matthew D.; Salerno, K. Michael; Grest, Gary S.; Fan, Hongyou

2017-06-01

High-pressure experiments have successfully produced a variety of gold nanostructures by compressing polymer coated spherical nanoparticles. We apply atomistic simulation to understand the role of the soft polymer response in determining the pressure-driven assembly of gold nanostructures. Quasi-isentropic experiments have shown that 1D, 2D and 3D nanostructures can be formed and recovered from dynamic compression of fcc superlattices of alkanethiol-coated gold nanocrystals on Sandia's Veloce pulsed power accelerator. Molecular modeling has shown that the dimensionality of the final structures depends on the orientation of the superlattice and the uniaxial loading. We describe the role of coating ligand length and grafting density, on ligand migration and deformation processes during pressure-driven coalescence of the cores into permanent nanowires, nanosheets and 3D structures. The role of uniaxial vs isotropic pressure and the effects of compression along various superlattice orientations will be discussed. Sandia National Laboratories is a multi-mission laboratory managed and operated by Sandia Corporation, a wholly owned subsidiary of Lockheed Martin Corporation, for the U.S. Department of Energy's National Nuclear Security Administration under contract DE-AC04-94AL85000.

Comparison of defects in ProTaper hand-operated and engine-driven instruments after clinical use.

PubMed

Cheung, G S P; Bian, Z; Shen, Y; Peng, B; Darvell, B W

2007-03-01

To compare the type of defects and mode of material failure of engine-driven and hand-operated ProTaper instruments after clinical use. A total of 401 hand-operated and 325 engine-driven ProTaper instruments were discarded from an endodontic clinic over 17 months. Those that had fractured were examined for plastic deformation in lateral view and remounted for fractographical examination in scanning electron microscope. The mode of fracture was classified as 'fatigue' or 'shear' failure. The lengths of fractured segments in both instruments were recorded. Any distortion in hand instrument was noted. Data were analysed using chi-square, Fisher's exact or Student's t-test, where appropriate. Approximately 14% of all discarded hand-operated instruments and 14% of engine-driven instruments were fractured. About 62% of hand instruments failed because of shear fracture, compared with approximately 66% of engine-driven instruments as a result of fatigue (P < 0.05). Approximately 16% of hand instruments were affected by shear, and either remained intact or was fractured, compared with 5% of engine-driven instruments (P < 0.05). The length of the broken fragment was significantly shorter in hand versus engine-driven group (P < 0.05). Approximately 7% of hand instruments were discarded intact but distorted (rarely for engine-driven instruments); all were in the form of unscrewing of the flutes. The location of defects in hand Finishing instruments was significantly closer to the tip than that for Shaping instruments (P < 0.05). Under the conditions of this study (possibly high usage), the failure mode of ProTaper engine-driven and hand-operated instruments appeared to be different, with shear failure being more prevalent in the latter.

75 FR 1063 - Clinical Laboratory Improvement Advisory Committee (CLIAC)

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Clinical Laboratory Improvement Advisory Committee (CLIAC) In accordance with section 10(a)(2) of the Federal Advisory... under which clinical laboratories are regulated; the impact on medical and laboratory practice of...

Clinical microbiology informatics.

PubMed

Rhoads, Daniel D; Sintchenko, Vitali; Rauch, Carol A; Pantanowitz, Liron

2014-10-01

The clinical microbiology laboratory has responsibilities ranging from characterizing the causative agent in a patient's infection to helping detect global disease outbreaks. All of these processes are increasingly becoming partnered more intimately with informatics. Effective application of informatics tools can increase the accuracy, timeliness, and completeness of microbiology testing while decreasing the laboratory workload, which can lead to optimized laboratory workflow and decreased costs. Informatics is poised to be increasingly relevant in clinical microbiology, with the advent of total laboratory automation, complex instrument interfaces, electronic health records, clinical decision support tools, and the clinical implementation of microbial genome sequencing. This review discusses the diverse informatics aspects that are relevant to the clinical microbiology laboratory, including the following: the microbiology laboratory information system, decision support tools, expert systems, instrument interfaces, total laboratory automation, telemicrobiology, automated image analysis, nucleic acid sequence databases, electronic reporting of infectious agents to public health agencies, and disease outbreak surveillance. The breadth and utility of informatics tools used in clinical microbiology have made them indispensable to contemporary clinical and laboratory practice. Continued advances in technology and development of these informatics tools will further improve patient and public health care in the future. Copyright © 2014, American Society for Microbiology. All Rights Reserved.

Clinical Microbiology Informatics

PubMed Central

Sintchenko, Vitali; Rauch, Carol A.; Pantanowitz, Liron

2014-01-01

SUMMARY The clinical microbiology laboratory has responsibilities ranging from characterizing the causative agent in a patient's infection to helping detect global disease outbreaks. All of these processes are increasingly becoming partnered more intimately with informatics. Effective application of informatics tools can increase the accuracy, timeliness, and completeness of microbiology testing while decreasing the laboratory workload, which can lead to optimized laboratory workflow and decreased costs. Informatics is poised to be increasingly relevant in clinical microbiology, with the advent of total laboratory automation, complex instrument interfaces, electronic health records, clinical decision support tools, and the clinical implementation of microbial genome sequencing. This review discusses the diverse informatics aspects that are relevant to the clinical microbiology laboratory, including the following: the microbiology laboratory information system, decision support tools, expert systems, instrument interfaces, total laboratory automation, telemicrobiology, automated image analysis, nucleic acid sequence databases, electronic reporting of infectious agents to public health agencies, and disease outbreak surveillance. The breadth and utility of informatics tools used in clinical microbiology have made them indispensable to contemporary clinical and laboratory practice. Continued advances in technology and development of these informatics tools will further improve patient and public health care in the future. PMID:25278581

U.S. Ebola Treatment Center Clinical Laboratory Support

PubMed Central

Jelden, Katelyn C.; Iwen, Peter C.; Herstein, Jocelyn J.; Biddinger, Paul D.; Kraft, Colleen S.; Saiman, Lisa; Smith, Philip W.; Hewlett, Angela L.; Gibbs, Shawn G.

2016-01-01

Fifty-five hospitals in the United States have been designated Ebola treatment centers (ETCs) by their state and local health authorities. Designated ETCs must have appropriate plans to manage a patient with confirmed Ebola virus disease (EVD) for the full duration of illness and must have these plans assessed through a CDC site visit conducted by an interdisciplinary team of subject matter experts. This study determined the clinical laboratory capabilities of these ETCs. ETCs were electronically surveyed on clinical laboratory characteristics. Survey responses were returned from 47 ETCs (85%). Forty-one (87%) of the ETCs planned to provide some laboratory support (e.g., point-of-care [POC] testing) within the room of the isolated patient. Forty-four (94%) ETCs indicated that their hospital would also provide clinical laboratory support for patient care. Twenty-two (50%) of these ETC clinical laboratories had biosafety level 3 (BSL-3) containment. Of all respondents, 34 (72%) were supported by their jurisdictional public health laboratory (PHL), all of which had available BSL-3 laboratories. Overall, 40 of 44 (91%) ETCs reported BSL-3 laboratory support via their clinical laboratory and/or PHL. This survey provided a snapshot of the laboratory support for designated U.S. ETCs. ETCs have approached high-level isolation critical care with laboratory support in close proximity to the patient room and by distributing laboratory support among laboratory resources. Experts might review safety considerations for these laboratory testing/diagnostic activities that are novel in the context of biocontainment care. PMID:26842705

Variable speed gas engine-driven air compressor system

NASA Astrophysics Data System (ADS)

Morgan, J. R.; Ruggles, A. E.; Chen, T. N.; Gehret, J.

1992-11-01

Tecogen Inc. and Ingersoll-Rand Co. as a subcontractor have designed a nominal 150-hp gas engine-driven air compressor utilizing the TECODRIVE 8000 engine and the Ingersoll-Rand 178.5-mm twin screw compressor. Phase 1 included the system engineering and design, economic and applications studies, and a draft commercialization plan. Phase 2 included controls development, laboratory prototype construction, and performance testing. The testing conducted verified that the compressor meets all design specifications.

Evaluation of autoCPAP devices in home treatment of sleep apnea/hypopnea syndrome.

PubMed

Meurice, J C; Cornette, A; Philip-Joet, F; Pepin, J L; Escourrou, P; Ingrand, P; Veale, D

2007-11-01

Quality of life (QOL) and sleepiness for patients with sleep apnea/hypopnea syndrome (SAHS) might improve with continuous positive airway pressure devices working in auto-adjust mode (autoCPAP) by allowing pressure modulations following patient needs. Clinical comparisons between devices driven by different algorithms are needed. We compared the clinical effectiveness of fixed pressure CPAP and four different autoCPAP devices by assessing compliance and QOL (36-item short-form health survey [SF-36]). SAHS patients were randomly allocated to five groups. Polysomnography (PSG) was performed to titrate the effective pressure in the constant CPAP group and evaluate residual apnea/hypopnea index (AHI) under autoCPAP. Follow-up consisted of clinical visits at three and six months by homecare technicians who assessed compliance, symptom scores and SF-36 scores. A laboratory-based PSG using the same CPAP/autoCPAP device as at home was performed at six months. Eighty-three patients (mean age 56+/-10 yrs) with mean body mass index (BMI) 30.8+/-5.3 kg/m(2) and severe SAHS (mean AHI: 52.3+/-17.8/h) were included. There were no differences in clinical symptoms or QOL scores, and similar clinical and PSG improvements were seen in all groups. CPAP use was >5 h per night, without any significant difference between groups. AutoCPAP is equally as effective as fixed CPAP for long-term home treatment in severe SAHS patients.

Competitive bidding for Medicare Part B clinical laboratory services.

PubMed

Kautter, John; Pope, Gregory C

2014-06-01

The traditional Medicare fee-for-service program may be able to purchase clinical laboratory test services at a lower cost through competitive bidding. Demonstrations of competitive bidding for clinical laboratory tests have been twice mandated or authorized by Congress but never implemented. This article provides a summary and review of the final design of the laboratory competitive bidding demonstration mandated by the Medicare Modernization Act of 2003. The design was analogous to a sealed bid (first price), clearing price auction. Design elements presented include covered laboratory tests and beneficiaries, laboratory bidding and payment status under the demonstration, composite bids, determining bidding winners and the demonstration fee schedule, and quality under the demonstration. Expanded use of competitive bidding in Medicare, including specifically for clinical laboratory tests, has been recommended in some proposals for Medicare reform. The presented design may be a useful point of departure if Medicare clinical laboratory competitive bidding is revived in the future.

Automation in Clinical Microbiology

PubMed Central

Ledeboer, Nathan A.

2013-01-01

Historically, the trend toward automation in clinical pathology laboratories has largely bypassed the clinical microbiology laboratory. In this article, we review the historical impediments to automation in the microbiology laboratory and offer insight into the reasons why we believe that we are on the cusp of a dramatic change that will sweep a wave of automation into clinical microbiology laboratories. We review the currently available specimen-processing instruments as well as the total laboratory automation solutions. Lastly, we outline the types of studies that will need to be performed to fully assess the benefits of automation in microbiology laboratories. PMID:23515547

[Laboratory management fee in national health insurance; what is required from clinical laboratory physicians? --message from Chairpersons].

PubMed

Kimura, Satoshi; Koshiba, Masahiro

2013-06-01

The laboratory management fee (LMF) in national health insurance ("Kentai-Kensa-Kanri-Kasan" in Japanese) has had a major impact on Japanese clinical laboratories, especially in recent years. In 2012, the fee was raised to approximately 5,000 yen per admitted patient. In order to address this national support, clinical pathologists are required to increase their knowledge and skills. On the other hand, there are insufficient clinical pathologists in Japan. In order to solve this problem, the Japanese Society of Laboratory Medicine (JSLM) approved a new license for Qualified Clinical Laboratory Managing Physicians (CLMPs), in addition to Certified Clinical Laboratory Physicians (CCLPs). The requirements to become a CLMP are less strict than for CCLP. There are approximately 500 CLMPs and 600 CCLPs in this country. The aim of this symposium was to offer opportunities to increase attendees' clinical skills, especially CLMPs and young clinical pathologists. Four CCLPs were chosen as speakers from a university hospital, a major city hospital, a medium-sized acute care hospital, and a university hospital anatomical pathologist, together with a chief medical technologist from a university hospital. All the speakers presented their ideal role models of clinical pathologists matching LMF requirements. JSLM together with the Japanese Association of Clinical Laboratory Physicians (JACLaP) sponsored this symposium. It was a successful meeting with more than two hundred attendees.

76 FR 5379 - Clinical Laboratory Improvement Advisory Committee (CLIAC)

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-31

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Clinical... for, and the nature of, revisions to the standards under which clinical laboratories are regulated... Coordinating Council on the Clinical Laboratory Workforce; the National Institutes of Health Genetic Test...

Sterilisation in the laboratory autoclave using direct air displacement by steam.

PubMed Central

Everall, P H; Morris, C A; Yarnell, R

1978-01-01

A device using a steam injection funnel is described by means of which air can be driven quickly and surely from an autoclave load. It is simple and inexpensive, necessitates no changes in the working routine of a microbiology laboratory, and does not interfere with the operation of the autoclave in its normal mode. Images Fig. 1 Fig. 3 PMID:344345

Argument-Driven Inquiry: Using the Laboratory to Improve Undergraduates' Science Writing Skills through Meaningful Science Writing, Peer-Review, and Revision

ERIC Educational Resources Information Center

Walker, Joi Phelps; Sampson, Victor

2013-01-01

This paper presents preliminary evidence supporting the use of peer review in undergraduate science as a means to improve student writing and to alleviate barriers, such as lost class time, by incorporation of the peer-review process into the laboratory component of the course. The study was conducted in a single section of an undergraduate…

iLAP: a workflow-driven software for experimental protocol development, data acquisition and analysis

PubMed Central

2009-01-01

Background In recent years, the genome biology community has expended considerable effort to confront the challenges of managing heterogeneous data in a structured and organized way and developed laboratory information management systems (LIMS) for both raw and processed data. On the other hand, electronic notebooks were developed to record and manage scientific data, and facilitate data-sharing. Software which enables both, management of large datasets and digital recording of laboratory procedures would serve a real need in laboratories using medium and high-throughput techniques. Results We have developed iLAP (Laboratory data management, Analysis, and Protocol development), a workflow-driven information management system specifically designed to create and manage experimental protocols, and to analyze and share laboratory data. The system combines experimental protocol development, wizard-based data acquisition, and high-throughput data analysis into a single, integrated system. We demonstrate the power and the flexibility of the platform using a microscopy case study based on a combinatorial multiple fluorescence in situ hybridization (m-FISH) protocol and 3D-image reconstruction. iLAP is freely available under the open source license AGPL from http://genome.tugraz.at/iLAP/. Conclusion iLAP is a flexible and versatile information management system, which has the potential to close the gap between electronic notebooks and LIMS and can therefore be of great value for a broad scientific community. PMID:19941647

Electrically Driven Thermal Management: Flight Validation, Experiment Development, Future Technologies

NASA Technical Reports Server (NTRS)

Didion, Jeffrey R.

2018-01-01

Electrically Driven Thermal Management is an active research and technology development initiative incorporating ISS technology flight demonstrations (STP-H5), development of Microgravity Science Glovebox (MSG) flight experiment, and laboratory-based investigations of electrically based thermal management techniques. The program targets integrated thermal management for future generations of RF electronics and power electronic devices. This presentation reviews four program elements: i.) results from the Electrohydrodynamic (EHD) Long Term Flight Demonstration launched in February 2017 ii.) development of the Electrically Driven Liquid Film Boiling Experiment iii.) two University based research efforts iv.) development of Oscillating Heat Pipe evaluation at Goddard Space Flight Center.

[Quality Management and Quality Specifications of Laboratory Tests in Clinical Studies--Challenges in Pre-Analytical Processes in Clinical Laboratories].

PubMed

Ishibashi, Midori

2015-01-01

The cost, speed, and quality are the three important factors recently indicated by the Ministry of Health, Labour and Welfare (MHLW) for the purpose of accelerating clinical studies. Based on this background, the importance of laboratory tests is increasing, especially in the evaluation of clinical study participants' entry and safety, and drug efficacy. To assure the quality of laboratory tests, providing high-quality laboratory tests is mandatory. For providing adequate quality assurance in laboratory tests, quality control in the three fields of pre-analytical, analytical, and post-analytical processes is extremely important. There are, however, no detailed written requirements concerning specimen collection, handling, preparation, storage, and shipping. Most laboratory tests for clinical studies are performed onsite in a local laboratory; however, a part of laboratory tests is done in offsite central laboratories after specimen shipping. As factors affecting laboratory tests, individual and inter-individual variations are well-known. Besides these factors, standardizing the factors of specimen collection, handling, preparation, storage, and shipping, may improve and maintain the high quality of clinical studies in general. Furthermore, the analytical method, units, and reference interval are also important factors. It is concluded that, to overcome the problems derived from pre-analytical processes, it is necessary to standardize specimen handling in a broad sense.

Obtaining patient test results from clinical laboratories: a survey of state law for pharmacists.

PubMed

Witry, Matthew J; Doucette, William R

2009-01-01

To identify states with laws that restrict to whom clinical laboratories may release copies of laboratory test results and to describe how these laws may affect pharmacists' ability to obtain patient laboratory test results. Researchers examined state statutes and administrative codes for all 50 states and the District of Columbia at the University of Iowa Law Library between June and July 2007. Researchers also consulted with lawyers, state Clinical Laboratory Improvement Amendments officers, and law librarians. Laws relating to the study objective were analyzed. 34 jurisdictions do not restrict the release of laboratory test results, while 17 states have laws that restrict to whom clinical laboratories can send copies of test results. In these states, pharmacists will have to use alternative sources, such as physician offices, to obtain test results. Pharmacists must consider state law before requesting copies of laboratory test results from clinical laboratories. This may be an issue that state pharmacy associations can address to increase pharmacist access to important patient information.

The ideal laboratory information system.

PubMed

Sepulveda, Jorge L; Young, Donald S

2013-08-01

Laboratory information systems (LIS) are critical components of the operation of clinical laboratories. However, the functionalities of LIS have lagged significantly behind the capacities of current hardware and software technologies, while the complexity of the information produced by clinical laboratories has been increasing over time and will soon undergo rapid expansion with the use of new, high-throughput and high-dimensionality laboratory tests. In the broadest sense, LIS are essential to manage the flow of information between health care providers, patients, and laboratories and should be designed to optimize not only laboratory operations but also personalized clinical care. To list suggestions for designing LIS with the goal of optimizing the operation of clinical laboratories while improving clinical care by intelligent management of laboratory information. Literature review, interviews with laboratory users, and personal experience and opinion. Laboratory information systems can improve laboratory operations and improve patient care. Specific suggestions for improving the function of LIS are listed under the following sections: (1) Information Security, (2) Test Ordering, (3) Specimen Collection, Accessioning, and Processing, (4) Analytic Phase, (5) Result Entry and Validation, (6) Result Reporting, (7) Notification Management, (8) Data Mining and Cross-sectional Reports, (9) Method Validation, (10) Quality Management, (11) Administrative and Financial Issues, and (12) Other Operational Issues.

The quality of veterinary in-clinic and reference laboratory biochemical testing.

PubMed

Rishniw, Mark; Pion, Paul D; Maher, Tammy

2012-03-01

Although evaluation of biochemical analytes in blood is common in veterinary practice, studies assessing the global quality of veterinary in-clinic and reference laboratory testing have not been reported. The aim of this study was to assess the quality of biochemical testing in veterinary laboratories using results obtained from analyses of 3 levels of assayed quality control materials over 5 days. Quality was assessed by comparison of calculated total error with quality requirements, determination of sigma metrics, use of a quality goal index to determine factors contributing to poor performance, and agreement between in-clinic and reference laboratory mean results. The suitability of in-clinic and reference laboratory instruments for statistical quality control was determined using adaptations from the computerized program, EZRules3. Reference laboratories were able to achieve desirable quality requirements more frequently than in-clinic laboratories. Across all 3 materials, > 50% of in-clinic analyzers achieved a sigma metric ≥ 6.0 for measurement of 2 analytes, whereas > 50% of reference laboratory analyzers achieved a sigma metric ≥ 6.0 for measurement of 6 analytes. Expanded uncertainty of measurement and ± total allowable error resulted in the highest mean percentages of analytes demonstrating agreement between in-clinic and reference laboratories. Owing to marked variation in bias and coefficient of variation between analyzers of the same and different types, the percentages of analytes suitable for statistical quality control varied widely. These findings reflect the current state-of-the-art with regard to in-clinic and reference laboratory analyzer performance and provide a baseline for future evaluations of the quality of veterinary laboratory testing. © 2012 American Society for Veterinary Clinical Pathology.

A standard-driven approach for electronic submission to pharmaceutical regulatory authorities.

PubMed

Lin, Ching-Heng; Chou, Hsin-I; Yang, Ueng-Cheng

2018-03-01

Using standards is not only useful for data interchange during the process of a clinical trial, but also useful for analyzing data in a review process. Any step, which speeds up approval of new drugs, may benefit patients. As a result, adopting standards for regulatory submission becomes mandatory in some countries. However, preparing standard-compliant documents, such as annotated case report form (aCRF), needs a great deal of knowledge and experience. The process is complex and labor-intensive. Therefore, there is a need to use information technology to facilitate this process. Instead of standardizing data after the completion of a clinical trial, this study proposed a standard-driven approach. This approach was achieved by implementing a computer-assisted "standard-driven pipeline (SDP)" in an existing clinical data management system. SDP used CDISC standards to drive all processes of a clinical trial, such as the design, data acquisition, tabulation, etc. RESULTS: A completed phase I/II trial was used to prove the concept and to evaluate the effects of this approach. By using the CDISC-compliant question library, aCRFs were generated automatically when the eCRFs were completed. For comparison purpose, the data collection process was simulated and the collected data was transformed by the SDP. This new approach reduced the missing data fields from sixty-two to eight and the controlled term mismatch field reduced from eight to zero during data tabulation. This standard-driven approach accelerated CRF annotation and assured data tabulation integrity. The benefits of this approach include an improvement in the use of standards during the clinical trial and a reduction in missing and unexpected data during tabulation. The standard-driven approach is an advanced design idea that can be used for future clinical information system development. Copyright © 2018 Elsevier Inc. All rights reserved.

What's to Be Done About Laboratory Quality? Process Indicators, Laboratory Stewardship, the Outcomes Problem, Risk Assessment, and Economic Value: Responding to Contemporary Global Challenges.

PubMed

Meier, Frederick A; Badrick, Tony C; Sikaris, Kenneth A

2018-02-17

For 50 years, structure, process, and outcomes measures have assessed health care quality. For clinical laboratories, structural quality has generally been assessed by inspection. For assessing process, quality indicators (QIs), statistical monitors of steps in the clinical laboratory total testing, have proliferated across the globe. Connections between structural and process laboratory measures and patient outcomes, however, have rarely been demonstrated. To inform further development of clinical laboratory quality systems, we conducted a selective but worldwide review of publications on clinical laboratory quality assessment. Some QIs, like seven generic College of American Pathologists Q-Tracks monitors, have demonstrated significant process improvement; other measures have uncovered critical opportunities to improve test selection and result management. The College of Pathologists of Australasia Key Indicator Monitoring and Management System has deployed risk calculations, introduced from failure mode effects analysis, as surrogate measures for outcomes. Showing economic value from clinical laboratory testing quality is a challenge. Clinical laboratories should converge on fewer (7-14) rather than more (21-35) process monitors; monitors should cover all steps of the testing process under laboratory control and include especially high-risk specimen-quality QIs. Clinical laboratory stewardship, the combination of education interventions among clinician test orderers and report consumers with revision of test order formats and result reporting schemes, improves test ordering, but improving result reception is more difficult. Risk calculation reorders the importance of quality monitors by balancing three probabilities: defect frequency, weight of potential harm, and detection difficulty. The triple approach of (1) a more focused suite of generic consensus quality indicators, (2) more active clinical laboratory testing stewardship, and (3) integration of formal risk assessment, rather than competing with economic value, enhances it.

Informatic system for a global tissue–fluid biorepository with a graph theory–oriented graphical user interface

PubMed Central

Butler, William E.; Atai, Nadia; Carter, Bob; Hochberg, Fred

2014-01-01

The Richard Floor Biorepository supports collaborative studies of extracellular vesicles (EVs) found in human fluids and tissue specimens. The current emphasis is on biomarkers for central nervous system neoplasms but its structure may serve as a template for collaborative EV translational studies in other fields. The informatic system provides specimen inventory tracking with bar codes assigned to specimens and containers and projects, is hosted on globalized cloud computing resources, and embeds a suite of shared documents, calendars, and video-conferencing features. Clinical data are recorded in relation to molecular EV attributes and may be tagged with terms drawn from a network of externally maintained ontologies thus offering expansion of the system as the field matures. We fashioned the graphical user interface (GUI) around a web-based data visualization package. This system is now in an early stage of deployment, mainly focused on specimen tracking and clinical, laboratory, and imaging data capture in support of studies to optimize detection and analysis of brain tumour–specific mutations. It currently includes 4,392 specimens drawn from 611 subjects, the majority with brain tumours. As EV science evolves, we plan biorepository changes which may reflect multi-institutional collaborations, proteomic interfaces, additional biofluids, changes in operating procedures and kits for specimen handling, novel procedures for detection of tumour-specific EVs, and for RNA extraction and changes in the taxonomy of EVs. We have used an ontology-driven data model and web-based architecture with a graph theory–driven GUI to accommodate and stimulate the semantic web of EV science. PMID:25317275

Informatic system for a global tissue-fluid biorepository with a graph theory-oriented graphical user interface.

PubMed

Butler, William E; Atai, Nadia; Carter, Bob; Hochberg, Fred

2014-01-01

The Richard Floor Biorepository supports collaborative studies of extracellular vesicles (EVs) found in human fluids and tissue specimens. The current emphasis is on biomarkers for central nervous system neoplasms but its structure may serve as a template for collaborative EV translational studies in other fields. The informatic system provides specimen inventory tracking with bar codes assigned to specimens and containers and projects, is hosted on globalized cloud computing resources, and embeds a suite of shared documents, calendars, and video-conferencing features. Clinical data are recorded in relation to molecular EV attributes and may be tagged with terms drawn from a network of externally maintained ontologies thus offering expansion of the system as the field matures. We fashioned the graphical user interface (GUI) around a web-based data visualization package. This system is now in an early stage of deployment, mainly focused on specimen tracking and clinical, laboratory, and imaging data capture in support of studies to optimize detection and analysis of brain tumour-specific mutations. It currently includes 4,392 specimens drawn from 611 subjects, the majority with brain tumours. As EV science evolves, we plan biorepository changes which may reflect multi-institutional collaborations, proteomic interfaces, additional biofluids, changes in operating procedures and kits for specimen handling, novel procedures for detection of tumour-specific EVs, and for RNA extraction and changes in the taxonomy of EVs. We have used an ontology-driven data model and web-based architecture with a graph theory-driven GUI to accommodate and stimulate the semantic web of EV science.

Laser scatter in clinical applications

NASA Astrophysics Data System (ADS)

Luther, Ed; Geddie, William

2008-02-01

Brightfield Laser Scanning Imaging (BLSI) is available on Laser Scanning Cytometers (LSCs) from CompuCyte Corporation. Briefly, digitation of photodetector outputs is coordinated with the combined motions of a small diameter (typically 2 to 10 microns) laser beam scanning a specimen in the Y direction (directed by a galvanometer-driven scanning mirror) and the microscope stage motion in the X direction. The output measurements are assembled into a two-dimensional array to provide a "non-real" digital image, where each pixel value reports the amount of laser-scattered light that is obtained when the laser beam is centered on that location. Depending on the detector positions, these images are analogous to Differential Interference Contrast or Phase Contrast microscopy. We report the incorporation of the new laser scattering capabilities into the workflow of a high-volume clinical cytology laboratory at University Health Network, Toronto, Canada. The laboratory has been employing LSC technology since 2003 for immunophenotypic fluorescence analysis of approximately 1200 cytological specimens per year, using the Clatch methodology. The new BLSI component allows visualization of cellular morphology at higher resolution levels than is possible with standard brightfield microscopic evaluation of unstained cells. BLSI is incorporated into the triage phase, where evaluation of unstained samples is combined with fluorescence evaluation to obtain specimen background levels. Technical details of the imaging methodology will be presented, as well as illustrative examples from current studies and comparisons to detailed, but obscure, historical studies of cytology specimens based on phase contrast microscopy.

Choosing the right laboratory: a review of clinical and forensic toxicology services for urine drug testing in pain management.

PubMed

Reisfield, Gary M; Goldberger, Bruce A; Bertholf, Roger L

2015-01-01

Urine drug testing (UDT) services are provided by a variety of clinical, forensic, and reference/specialty laboratories. These UDT services differ based on the principal activity of the laboratory. Clinical laboratories provide testing primarily focused on medical care (eg, emergency care, inpatients, and outpatient clinics), whereas forensic laboratories perform toxicology tests related to postmortem and criminal investigations, and drug-free workplace programs. Some laboratories now provide UDT specifically designed for monitoring patients on chronic opioid therapy. Accreditation programs for clinical laboratories have existed for nearly half a century, and a federal certification program for drug-testing laboratories was established in the 1980s. Standards of practice for forensic toxicology services other than workplace drug testing have been established in recent years. However, no accreditation program currently exists for UDT in pain management, and this review considers several aspects of laboratory accreditation and certification relevant to toxicology services, with the intention to provide guidance to clinicians in their selection of the appropriate laboratory for UDT surveillance of their patients on opioid therapy.

U.S. Ebola Treatment Center Clinical Laboratory Support.

PubMed

Jelden, Katelyn C; Iwen, Peter C; Herstein, Jocelyn J; Biddinger, Paul D; Kraft, Colleen S; Saiman, Lisa; Smith, Philip W; Hewlett, Angela L; Gibbs, Shawn G; Lowe, John J

2016-04-01

Fifty-five hospitals in the United States have been designated Ebola treatment centers (ETCs) by their state and local health authorities. Designated ETCs must have appropriate plans to manage a patient with confirmed Ebola virus disease (EVD) for the full duration of illness and must have these plans assessed through a CDC site visit conducted by an interdisciplinary team of subject matter experts. This study determined the clinical laboratory capabilities of these ETCs. ETCs were electronically surveyed on clinical laboratory characteristics. Survey responses were returned from 47 ETCs (85%). Forty-one (87%) of the ETCs planned to provide some laboratory support (e.g., point-of-care [POC] testing) within the room of the isolated patient. Forty-four (94%) ETCs indicated that their hospital would also provide clinical laboratory support for patient care. Twenty-two (50%) of these ETC clinical laboratories had biosafety level 3 (BSL-3) containment. Of all respondents, 34 (72%) were supported by their jurisdictional public health laboratory (PHL), all of which had available BSL-3 laboratories. Overall, 40 of 44 (91%) ETCs reported BSL-3 laboratory support via their clinical laboratory and/or PHL. This survey provided a snapshot of the laboratory support for designated U.S. ETCs. ETCs have approached high-level isolation critical care with laboratory support in close proximity to the patient room and by distributing laboratory support among laboratory resources. Experts might review safety considerations for these laboratory testing/diagnostic activities that are novel in the context of biocontainment care. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

Current Pre- and Post-Graduate Vocational Education and Training in Laboratory Medicine and Microbiology in Poland

PubMed Central

Owczarek, Henryk

2010-01-01

The status of Polish medical laboratories in continuously changing. Since 2001 the legal framework was established for the clinical chemists employed in medical and microbiological laboratories. Since that time, the job performance by clinical chemists is limited only to the specialist, member of the Polish Chamber of Laboratory Diagnosticians. According to that legal act, graduate in laboratory medicine is certified to perform the professional activities in medical or microbiological laboratories without further vocational training. After graduating from biology, chemistry, pharmacy or veterinary medicine, a person can perform the job only under supervision of a certified clinical chemist. Several Medical Universities have organized the system of post-graduation education for such graduates. The main courses taught are basic pathology, internal medicine, hematology, immunology, and clinical chemistry. In addition, the Ministry of Health and Chamber of Laboratory Diagnosticians are organizing and supervising the higher level of post-graduate education for clinical chemists, the education and vocational training which leads to the title of specialist in clinical chemistry or similar area in laboratory medicine. The professional qualification of such person are evaluated during the final exam at the national level. The specialist is eligible to act as director of clinical laboratories. PMID:27683359

Materials for stem cell factories of the future

NASA Astrophysics Data System (ADS)

Celiz, Adam D.; Smith, James G. W.; Langer, Robert; Anderson, Daniel G.; Winkler, David A.; Barrett, David A.; Davies, Martyn C.; Young, Lorraine E.; Denning, Chris; Alexander, Morgan R.

2014-06-01

Polymeric substrates are being identified that could permit translation of human pluripotent stem cells from laboratory-based research to industrial-scale biomedicine. Well-defined materials are required to allow cell banking and to provide the raw material for reproducible differentiation into lineages for large-scale drug-screening programs and clinical use. Yet more than 1 billion cells for each patient are needed to replace losses during heart attack, multiple sclerosis and diabetes. Producing this number of cells is challenging, and a rethink of the current predominant cell-derived substrates is needed to provide technology that can be scaled to meet the needs of millions of patients a year. In this Review, we consider the role of materials discovery, an emerging area of materials chemistry that is in large part driven by the challenges posed by biologists to materials scientists.

42 CFR 493.1415 - Condition: Laboratories performing moderate complexity testing; clinical consultant.

Code of Federal Regulations, 2010 CFR

2010-10-01

... complexity testing; clinical consultant. 493.1415 Section 493.1415 Public Health CENTERS FOR MEDICARE... § 493.1415 Condition: Laboratories performing moderate complexity testing; clinical consultant. The laboratory must have a clinical consultant who meets the qualification requirements of § 493.1417 of this...

Development opportunities for hospital clinical laboratory joint ventures.

PubMed

Van Riper, J A

1995-01-01

Regional health-care providers are being given the opportunity to collaborate in specialty health-care services. Collaboration to achieve superior economies of scale is very effective in the clinical laboratory industry. National laboratory chains are consolidating and enhancing their control of the industry to ensure their historic profitability. National companies have closed many laboratory facilities and have laid off substantial numbers of laboratory personnel. Health-care providers can regain control of their locally generated laboratory health-care dollars by joining forces with clinical laboratory joint ventures. Laboratorians can assist the healthcare providers in bringing laboratory services and employment back to the local community. New capital for operational development and laboratory information systems will help bring the laboratory to the point of care. The independent regional laboratory is focused on supporting the medical needs of the community. The profit generated from a laboratory joint venture is shared among local health-care providers, supporting their economic viability. The laboratories' ability to contribute to the development of profit-making ventures will provide capital for new laboratory development. All of the above will ensure the clinical laboratories' role in providing quality health care to our communities and employment opportunities for laboratory personnel.

[The quality management in clinical diagnostic laboratory in conditions of the Federal Center of traumatology, orthopedics and endoprosthesis replacement of Minzdrav of Russia (Cheboksary)].

PubMed

Nikolaev, N S; Nazarova, V V; Dobrovol'skaia, N Iu; Orlova, A V; Pchelova, N N

2014-10-01

The article presents experience of clinical diagnostic laboratory of the Federal Center of traumatology, orthopedics and endoprosthesis replacement of Minzdrav of Russia (Cheboksary) in the area of quality management of medical laboratory services on the basis of evaluation of efficacy and effectiveness of processes. The factors effecting quality of functioning of clinical diagnostic laboratory are indicated. The criteria and indicators of efficacy of work of employees of clinical diagnostic laboratory are presented.

Gas-driven permeation of deuterium through tungsten and tungsten alloys

DOE PAGES

Buchenauer, Dean A.; Karnesky, Richard A.; Fang, Zhigang Zak; ...

2016-03-25

Here, to address the transport and trapping of hydrogen isotopes, several permeation experiments are being pursued at both Sandia National Laboratories (deuterium gas-driven permeation) and Idaho National Laboratories (tritium gas- and plasma-driven tritium permeation). These experiments are in part a collaboration between the US and Japan to study the performance of tungsten at divertor relevant temperatures (PHENIX). Here we report on the development of a high temperature (≤1150 °C) gas-driven permeation cell and initial measurements of deuterium permeation in several types of tungsten: high purity tungsten foil, ITER-grade tungsten (grains oriented through the membrane), and dispersoid-strengthened ultra-fine grain (UFG) tungstenmore » being developed in the US. Experiments were performed at 500–1000 °C and 0.1–1.0 atm D 2 pressure. Permeation through ITER-grade tungsten was similar to earlier W experiments by Frauenfelder (1968–69) and Zaharakov (1973). Data from the UFG alloy indicates marginally higher permeability (< 10×) at lower temperatures, but the permeability converges to that of the ITER tungsten at 1000 °C. The permeation cell uses only ceramic and graphite materials in the hot zone to reduce the possibility for oxidation of the sample membrane. Sealing pressure is applied externally, thereby allowing for elevation of the temperature for brittle membranes above the ductile-to-brittle transition temperature.« less

77 FR 31359 - Medicare and Medicaid Programs; Announcement of the Re-Approval of the Joint Commission as an...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-25

... Organization Under the Clinical Laboratory Improvement Amendments of 1988 AGENCY: Centers for Medicare... Commission for re-approval as an accreditation organization for clinical laboratories under the Clinical... On October 31, 1988, the Congress enacted the Clinical Laboratory Improvement Amendments of 1988...

A Critical Review of the Effects of Nicotine and Alcohol Coadministration in Human Laboratory Studies.

PubMed

Dermody, Sarah S; Hendershot, Christian S

2017-03-01

Simultaneous use of cigarettes and alcohol is common and may be driven by nicotine increasing alcohol self-administration or vice versa. To better evaluate the causal nature of this relationship, we systematically reviewed human experimental laboratory studies that coadministered nicotine and alcohol with control conditions. Searches of PubMed/MEDLINE and PsycINFO databases and study bibliographies identified 30 studies that met our inclusion criteria. Research methodologies were critically reviewed. Effects of coadministration on drug self-administration and related factors such as craving, subjective response, motivation, and heart rate are reported. Results most strongly supported that alcohol increases nicotine and cigarette self-administration, whereas, depending on the context, nicotine increased, decreased, or had no effect on alcohol self-administration. Craving and subjective drug effects were also impacted by coadministration. Interaction effects of nicotine and alcohol on self-administration and subjective responses were reported infrequently. The effects may be moderated by a number of factors, including dose of administered drug and sex. Recommendations are made for future research, and clinical and policy implications of findings are discussed. Copyright © 2017 by the Research Society on Alcoholism.

[Accreditation of clinical laboratories based on ISO standards].

PubMed

Kawai, Tadashi

2004-11-01

International Organization for Standardization (ISO) have published two international standards (IS) to be used for accreditation of clinical laboratories; ISO/IEC 17025:1999 and ISO 15189:2003. Any laboratory accreditation body must satisfy the requirements stated in ISO/IEC Guide 58. In order to maintain the quality of the laboratory accreditation bodies worldwide, the International Laboratory Accreditation Cooperation (ILAC) has established the mutual recognition arrangement (MRA). In Japan, the International Accreditation Japan (IAJapan) and the Japan Accreditation Board for Conformity Assessment (JAB) are the members of the ILAC/MRA group. In 2003, the Japanese Committee for Clinical Laboratory Standards (JCCLS) and the JAB have established the Development Committee of Clinical Laboratory Accreditation Program (CLAP), in order to establish the CLAP, probably starting in 2005.

Diagnosis and management of factor V Leiden.

PubMed

Campello, Elena; Spiezia, Luca; Simioni, Paolo

2016-12-01

The discovery of the factor V Leiden (FVL) missense mutation (Arg506Gln) causing factor V resistance to the anticoagulant action of activated protein C was a landmark that allowed a better understanding of the basis of inherited thrombotic risk. FVL mutation is currently the most common known hereditary defect predisposing to venous thrombosis. Areas covered: Novel data-driven FVL diagnosis and therapeutic approaches in the management of FVL carriers in various clinical settings. Brief conclusions on topics of direct clinical relevance including currently available indications for primary and secondary prophylaxis, the management of female, pediatric carriers and asymptomatic relatives. Latest evidence on the association between FVL and cancer, as well as the possible use of direct oral anticoagulant therapy. Expert commentary: Although FVL diagnosis nowadays is highly accurate, many doubts remain regarding the best management and therapeutic protocols. The main role of clinicians is to tailor therapeutic strategies to carriers and their relatives. High familial penetrance, distinctive aspects of the first thrombotic event (provoked/unprovoked, age, etc.) and laboratory biomarkers can guide the optimal management of secondary antithrombotic prophylaxis, primary prophylaxis in asymptomatic individuals, and whether to screen relatives.

Stochastic Multiscale Analysis and Design of Engine Disks

DTIC Science & Technology

2010-07-28

shown recently to fail when used with data-driven non-linear stochastic input models (KPCA, IsoMap, etc.). Need for scalable exascale computing algorithms Materials Process Design and Control Laboratory Cornell University

Buyer and seller data from pay what you want and name your own price laboratory markets.

PubMed

Krämer, Florentin; Schmidt, Klaus M; Spann, Martin; Stich, Lucas

2017-06-01

Pay What You Want (PWYW) and Name Your Own Price (NYOP) are customer-driven pricing mechanisms that give customers (some) pricing power and that have been used in service industries with high fixed costs to price discriminate without setting a reference price. This paper describes buyer and seller data in a series of induced-value laboratory experiments that compare PWYW and NYOP in monopoly and competitive situations. Sellers are in a one-shot interaction with buyers. Sellers using customer-driven pricing mechanisms may exogenously or endogenously receive additional promotional benefits, for instance through word-of-mouth effects. The major findings based on the data presented here are reported in the paper "Delegating Pricing Power to Customers: Pay What You Want or Name Your Own Price?" (Krämer et al., 2017) [3].

Prevalence of Estimated GFR Reporting Among US Clinical Laboratories

PubMed Central

Accetta, Nancy A.; Gladstone, Elisa H.; DiSogra, Charles; Wright, Elizabeth C.; Briggs, Michael; Narva, Andrew S.

2008-01-01

Background Routine laboratory reporting of estimated glomerular filtration rate (eGFR) may help clinicians detect kidney disease. The current national prevalence of eGFR reporting among clinical laboratories is unknown, thus the extent of the situation of laboratories not routinely reporting eGFR with serum creatinine (SCr) results is not quantified. Design Observational analysis. Setting National Kidney Disease Education Program survey of clinical laboratory conducted in 2006-7 by mail, Web, and telephone follow up. Participants A national random sample, 6,350 clinical laboratories, drawn from the Federal Clinical Laboratory Improvement Amendments database and stratified by six major laboratory types/groupings. Predictors Laboratory reports SCr results. Outcomes Reporting eGFR values along with SCr results. Measurements Percent of laboratories reporting eGFR along with reporting SCr, reporting protocol, eGFR formula used, and style of reporting cutoff values. Results Among laboratories reporting SCr, 38.4% report eGFR (physician offices, 25.8%; hospitals, 43.6%; independents, 38.9%; community clinics, 47.2%; health fair/insurance/public health, 45.5%; others, 43.2%). Physician office laboratories have a reporting prevalence lower than other laboratory types (p < 0.001). Among laboratories reporting eGFR, 66.7% do so routinely with all adult SCr determinations; 71.6% use the 4-variable Modification of Diet in Renal Disease Study equation; and 45.3% use the “>60 mL/min/1.73 m2” reporting convention. Independent laboratories are least likely to routinely report eGFR, (50.6%, p < .05) and most likely to report only when specifically requested (45.4%, p < 0.05). High-volume laboratories across all strata are more likely to report eGFR (p < 0.001). Limitations Self-reporting by laboratories, Federal database did not have names of laboratory directors/managers (intended respondents), assumed accuracy of Federal database for sample purposes. Conclusions Routine eGFR reporting with SCr is not yet universal and laboratories vary in their reporting practices. PMID:18676076

Axisymmetric magnetorotational instability in ideal and viscous laboratory plasmas

NASA Astrophysics Data System (ADS)

Mikhailovskii, A. B.; Lominadze, J. G.; Churikov, A. P.; Erokhin, N. N.; Pustovitov, V. D.; Konovalov, S. V.

2008-10-01

The original analysis of the axisymmetric magnetorotational instability (MRI) by Velikhov (Sov. Phys. JETP 9, 995 (1959)) and Chandrasekhar (Proc. Nat. Acad. Sci. 46, 253 (1960)), applied to the ideally conducting magnetized medium in the laboratory conditions and restricted to the incompressible approximation, is extended by allowing for the compressibility. Thereby, two additional driving mechanisms of MRI are revealed in addition to the standard drive due to the negative medium rotation frequency gradient (the Velikhov effect). One is due to the squared medium pressure gradient and another is a combined effect of the pressure and density gradients. For laboratory applications, the expression for the MRI boundary with all the above driving mechanisms and the stabilizing magnetoacoustic effect is derived. The effects of parallel and perpendicular viscosities on the MRI in the laboratory plasma are investigated. It is shown that, for strong viscosity, there is a family of MRI driven for the same condition as the ideal one. It is also revealed that the presence of strong viscosity leads to additional family of instabilities called the viscosity-driven MRI. Then the parallel-viscositydriven MRI looks as an overstability (oscillatory instability) possessing both the growth rate and the real part of oscillation frequency, while the perpendicular-viscosity MRI is the aperiodical instability.

The management of clinical laboratories in Europe: a FESCC survey. Forum of the European Societies of Clinical Chemistry and Laboratory Medicine.

PubMed

de Kieviet, Wim; Blaton, Victor; Kovacs, Gabor L; Palicka, Vladimir; Pulkki, Kari

2002-03-01

The professional duties of the specialists in clinical chemistry differ from country to country in Europe. One of the main goals of the Strategic Plan of the Forum of the European Societies of Clinical Chemistry and Laboratory Medicine (FESCC; IFCC-Europe) is to promote a high scientific and professional standard in the field of clinical chemistry and laboratory medicine in Europe. This can be stimulated by the knowledge of the local conditions in each country and by striving towards a strong and harmonised position in all the European countries. In order to enhance the knowledge of the managerial situation of the specialists in clinical chemistry in Europe, FESCC launched a survey in September 2000. This survey provides information about the position of the specialists in clinical chemistry in the various disciplines in the medical laboratories and in hospitals, and about the advisory tasks and the managerial education during the post-graduate training in clinical chemistry. Of the 35 FESCC member countries 33 have participated in the survey (94%). The results show a rather heterogeneous situation in Europe caused by the local historical developments, the differences in academic background and the relative numbers of private and physicians' office laboratories. Large differences exist between the European countries in the disciplines of laboratory medicine that are headed by a specialist in clinical chemistry. In the different countries the clinical chemistry laboratories are headed by specialists in clinical chemistry in between 20% and 100% of the laboratories. The haematology, immunology, microbiology, therapeutic drug monitoring, molecular biology and haemostasis laboratories and departments of blood banking are headed by specialists in clinical chemistry in between 0% and 100% of the laboratories. The responsibilities for the various managerial tasks of the specialists in clinical chemistry show no uniformity in Europe. In the majority of the countries the general management, the purchase of equipment and reagents and the education of technicians are in >90% the responsibility of the specialists in clinical chemistry. In most countries the majority of the specialists in clinical chemistry are members of the medical staff of the hospitals and have a position equivalent to the position of specialists in other medical disciplines. In some countries, however, it only holds true for the specialists with a medical background. In 79% of the countries the law regulates the profession of the specialists in clinical chemistry and in 60% of the countries the law regulates their position in the medical staff of the hospital. The advisory tasks to physicians, general practitioners and other users of laboratory tests are practised by >90% of the laboratories in 64% of the countries. Information is given directly to the patients by >90% of the laboratories in 30% of the countries. Only in a few countries laboratories give information to the public. The post-graduate training in clinical chemistry includes a managerial training in 58% of the countries, the study of information technology in 61% of the countries and an economy and/or a business administration study in 15% of the countries. In 27% of the countries no managerial education forms part of the post-graduate study in clinical chemistry. Harmonisation of the managerial aspects of the profession is one of the challenges for the European specialists in clinical chemistry. A European syllabus for post-graduate training could be helpful.

Review and comparison of quality standards, guidelines and regulations for laboratories.

PubMed

Datema, Tjeerd A M; Oskam, Linda; Klatser, Paul R

2012-01-01

The variety and number of laboratory quality standards, guidelines and regulations (hereafter: quality documents) makes it difficult to choose the most suitable one for establishing and maintaining a laboratory quality management system. There is a need to compare the characteristics, suitability and applicability of quality documents in view of the increasing efforts to introduce quality management in laboratories, especially in clinical diagnostic laboratories in low income and middle income countries. This may provide valuable insights for policy makers developing national laboratory policies, and for laboratory managers and quality officers in choosing the most appropriate quality document for upgrading their laboratories. We reviewed the history of quality document development and then selected a subset based on their current use. We analysed these documents following a framework for comparison of quality documents that was adapted from the Clinical Laboratory Standards Institute guideline GP26 Quality management system model for clinical laboratory services . Differences were identified between national and international, and non-clinical and clinical quality documents. The most salient findings were the absence of provisions on occurrence management and customer service in almost all non-clinical quality documents, a low number of safety requirements aimed at protecting laboratory personnel in international quality documents and no requirements regarding ethical behaviour in almost all quality documents. Each laboratory needs to investigate whether national regulatory standards are present. These are preferred as they most closely suit the needs of laboratories in the country. A laboratory should always use both a standard and a guideline: a standard sums up the requirements to a quality management system, a guideline describes how quality management can be integrated in the laboratory processes.

[Knowledge management system for laboratory work and clinical decision support].

PubMed

Inada, Masanori; Sato, Mayumi; Yoneyama, Akiko

2011-05-01

This paper discusses a knowledge management system for clinical laboratories. In the clinical laboratory of Toranomon Hospital, we receive about 20 questions relevant to laboratory tests per day from medical doctors or co-medical staff. These questions mostly involve the essence to appropriately accomplish laboratory tests. We have to answer them carefully and suitably because an incorrect answer may cause a medical accident. Up to now, no method has been in place to achieve a rapid response and standardized answers. For this reason, the laboratory staff have responded to various questions based on their individual knowledge. We began to develop a knowledge management system to promote the knowledge of staff working for the laboratory. This system is a type of knowledge base for assisting the work, such as inquiry management, laboratory consultation, process management, and clinical support. It consists of several functions: guiding laboratory test information, managing inquiries from medical staff, reporting results of patient consultation, distributing laboratory staffs notes, and recording guidelines for laboratory medicine. The laboratory test information guide has 2,000 records of medical test information registered in the database with flexible retrieval. The inquiry management tool provides a methos to record all questions, answer easily, and retrieve cases. It helps staff to respond appropriately in a short period of time. The consulting report system treats patients' claims regarding medical tests. The laboratory staffs notes enter a file management system so they can be accessed to aid in clinical support. Knowledge sharing using this function can achieve the transition from individual to organizational learning. Storing guidelines for laboratory medicine will support EBM. Finally, it is expected that this system will support intellectual activity concerning laboratory work and contribute to the practice of knowledge management for clinical work support.

Regulatory issues in accreditation of toxicology laboratories.

PubMed

Bissell, Michael G

2012-09-01

Clinical toxicology laboratories and forensic toxicology laboratories operate in a highly regulated environment. This article outlines major US legal/regulatory issues and requirements relevant to accreditation of toxicology laboratories (state and local regulations are not covered in any depth). The most fundamental regulatory distinction involves the purposes for which the laboratory operates: clinical versus nonclinical. The applicable regulations and the requirements and options for operations depend most basically on this consideration, with clinical toxicology laboratories being directly subject to federal law including mandated options for accreditation and forensic toxicology laboratories being subject to degrees of voluntary or state government–required accreditation.

ASVCP quality assurance guidelines: control of preanalytical, analytical, and postanalytical factors for urinalysis, cytology, and clinical chemistry in veterinary laboratories.

PubMed

Gunn-Christie, Rebekah G; Flatland, Bente; Friedrichs, Kristen R; Szladovits, Balazs; Harr, Kendal E; Ruotsalo, Kristiina; Knoll, Joyce S; Wamsley, Heather L; Freeman, Kathy P

2012-03-01

In December 2009, the American Society for Veterinary Clinical Pathology (ASVCP) Quality Assurance and Laboratory Standards committee published the updated and peer-reviewed ASVCP Quality Assurance Guidelines on the Society's website. These guidelines are intended for use by veterinary diagnostic laboratories and veterinary research laboratories that are not covered by the US Food and Drug Administration Good Laboratory Practice standards (Code of Federal Regulations Title 21, Chapter 58). The guidelines have been divided into 3 reports: (1) general analytical factors for veterinary laboratory performance and comparisons; (2) hematology, hemostasis, and crossmatching; and (3) clinical chemistry, cytology, and urinalysis. This particular report is one of 3 reports and documents recommendations for control of preanalytical, analytical, and postanalytical factors related to urinalysis, cytology, and clinical chemistry in veterinary laboratories and is adapted from sections 1.1 and 2.2 (clinical chemistry), 1.3 and 2.5 (urinalysis), 1.4 and 2.6 (cytology), and 3 (postanalytical factors important in veterinary clinical pathology) of these guidelines. These guidelines are not intended to be all-inclusive; rather, they provide minimal guidelines for quality assurance and quality control for veterinary laboratory testing and a basis for laboratories to assess their current practices, determine areas for improvement, and guide continuing professional development and education efforts. © 2012 American Society for Veterinary Clinical Pathology.

The "hospital central laboratory": automation, integration and clinical usefulness.

PubMed

Zaninotto, Martina; Plebani, Mario

2010-07-01

Recent technological developments in laboratory medicine have led to a major challenge, maintaining a close connection between the search of efficiency through automation and consolidation and the assurance of effectiveness. The adoption of systems that automate most of the manual tasks characterizing routine activities has significantly improved the quality of laboratory performance; total laboratory automation being the paradigm of the idea that "human-less" robotic laboratories may allow for better operation and insuring less human errors. Furthermore, even if ongoing technological developments have considerably improved the productivity of clinical laboratories as well as reducing the turnaround time of the entire process, the value of qualified personnel remains a significant issue. Recent evidence confirms that automation allows clinical laboratories to improve analytical performances only if trained staff operate in accordance with well-defined standard operative procedures, thus assuring continuous monitoring of the analytical quality. In addition, laboratory automation may improve the appropriateness of test requests through the use of algorithms and reflex testing. This should allow the adoption of clinical and biochemical guidelines. In conclusion, in laboratory medicine, technology represents a tool for improving clinical effectiveness and patient outcomes, but it has to be managed by qualified laboratory professionals.

What's wrong with my mouse cage? Methodological considerations for modeling lifestyle factors and gene-environment interactions in mice.

PubMed

Mo, Christina; Renoir, Thibault; Hannan, Anthony J

2016-05-30

The mechanistic understanding of lifestyle contributions to disease has been largely driven by work in laboratory rodent models using environmental interventions. These interventions show an array of methodologies and sometimes unclear collective conclusions, hampering clinical interpretations. Here we discuss environmental enrichment, exercise and stress interventions to illustrate how different protocols can affect the interpretations of environmental factors in disease. We use Huntington's disease (HD) as an example because its mouse models exhibit excellent validity and HD was the first genetic animal model in which environmental stimulation was found to be beneficial. We make a number of observations and recommendations. Firstly, environmental enrichment and voluntary exercise generally show benefits across laboratories and mouse models. However, the extent to which these environmental interventions have beneficial effects depends on parameters such as the structural complexity of the cage in the case of enrichment, the timing of the intervention and the nature of the control conditions. In particular, clinical interpretations should consider deprived control living conditions and the ethological relevance of the enrichment. Secondly, stress can have negative effects on the phenotype in mouse models of HD and other brain disorders. When modeling stress, the effects of more than one type of experimental stressor should be investigated due to the heterogeneity and complexity of stress responses. With stress in particular, but ideally in all studies, both sexes should be used and the randomized group sizes need to be sufficiently powered to detect any sex effects. Opportunities for clinical translation will be guided by the 'environmental construct validity' of the preclinical data, including the culmination of complementary protocols across multiple animal models. Environmental interventions in mouse models of HD provide illustrative examples of how valid preclinical studies can lead to conclusions relevant to clinical populations. Copyright © 2015 Elsevier B.V. All rights reserved.

Note: A table-top blast driven shock tube

NASA Astrophysics Data System (ADS)

Courtney, Michael W.; Courtney, Amy C.

2010-12-01

The prevalence of blast-induced traumatic brain injury in conflicts in Iraq and Afghanistan has motivated laboratory scale experiments on biomedical effects of blast waves and studies of blast wave transmission properties of various materials in hopes of improving armor design to mitigate these injuries. This paper describes the design and performance of a table-top shock tube that is more convenient and widely accessible than traditional compression driven and blast driven shock tubes. The design is simple: it is an explosive driven shock tube employing a rifle primer that explodes when impacted by the firing pin. The firearm barrel acts as the shock tube, and the shock wave emerges from the muzzle. The small size of this shock tube can facilitate localized application of a blast wave to a subject, tissue, or material under test.

Note: A table-top blast driven shock tube.

PubMed

Courtney, Michael W; Courtney, Amy C

2010-12-01

The prevalence of blast-induced traumatic brain injury in conflicts in Iraq and Afghanistan has motivated laboratory scale experiments on biomedical effects of blast waves and studies of blast wave transmission properties of various materials in hopes of improving armor design to mitigate these injuries. This paper describes the design and performance of a table-top shock tube that is more convenient and widely accessible than traditional compression driven and blast driven shock tubes. The design is simple: it is an explosive driven shock tube employing a rifle primer that explodes when impacted by the firing pin. The firearm barrel acts as the shock tube, and the shock wave emerges from the muzzle. The small size of this shock tube can facilitate localized application of a blast wave to a subject, tissue, or material under test.

Customer satisfaction survey with clinical laboratory and phlebotomy services at a tertiary care unit level.

PubMed

Koh, Young Rae; Kim, Shine Young; Kim, In Suk; Chang, Chulhun L; Lee, Eun Yup; Son, Han Chul; Kim, Hyung Hoi

2014-09-01

We performed customer satisfaction surveys for physicians and nurses regarding clinical laboratory services, and for outpatients who used phlebotomy services at a tertiary care unit level to evaluate our clinical laboratory and phlebotomy services. Thus, we wish to share our experiences with the customer satisfaction survey for clinical laboratory and phlebotomy services. Board members of our laboratory designed a study procedure and study population, and developed two types of questionnaire. A satisfaction survey for clinical laboratory services was conducted with 370 physicians and 125 nurses by using an online or paper questionnaire. The satisfaction survey for phlebotomy services was performed with 347 outpatients who received phlebotomy services by using computer-aided interviews. Mean satisfaction scores of physicians and nurses was 58.1, while outpatients' satisfaction score was 70.5. We identified several dissatisfactions with our clinical laboratory and phlebotomy services. First, physicians and nurses were most dissatisfied with the specimen collection and delivery process. Second, physicians and nurses were dissatisfied with phlebotomy services. Third, molecular genetic and cytogenetic tests were found more expensive than other tests. This study is significant in that it describes the first reference survey that offers a survey procedure and questionnaire to assess customer satisfaction with clinical laboratory and phlebotomy services at a tertiary care unit level.

Customer Satisfaction Survey With Clinical Laboratory and Phlebotomy Services at a Tertiary Care Unit Level

PubMed Central

Koh, Young Rae; Kim, Shine Young; Kim, In Suk; Chang, Chulhun L.; Lee, Eun Yup; Son, Han Chul

2014-01-01

We performed customer satisfaction surveys for physicians and nurses regarding clinical laboratory services, and for outpatients who used phlebotomy services at a tertiary care unit level to evaluate our clinical laboratory and phlebotomy services. Thus, we wish to share our experiences with the customer satisfaction survey for clinical laboratory and phlebotomy services. Board members of our laboratory designed a study procedure and study population, and developed two types of questionnaire. A satisfaction survey for clinical laboratory services was conducted with 370 physicians and 125 nurses by using an online or paper questionnaire. The satisfaction survey for phlebotomy services was performed with 347 outpatients who received phlebotomy services by using computer-aided interviews. Mean satisfaction scores of physicians and nurses was 58.1, while outpatients' satisfaction score was 70.5. We identified several dissatisfactions with our clinical laboratory and phlebotomy services. First, physicians and nurses were most dissatisfied with the specimen collection and delivery process. Second, physicians and nurses were dissatisfied with phlebotomy services. Third, molecular genetic and cytogenetic tests were found more expensive than other tests. This study is significant in that it describes the first reference survey that offers a survey procedure and questionnaire to assess customer satisfaction with clinical laboratory and phlebotomy services at a tertiary care unit level. PMID:25187892

ms_lims, a simple yet powerful open source laboratory information management system for MS-driven proteomics.

PubMed

Helsens, Kenny; Colaert, Niklaas; Barsnes, Harald; Muth, Thilo; Flikka, Kristian; Staes, An; Timmerman, Evy; Wortelkamp, Steffi; Sickmann, Albert; Vandekerckhove, Joël; Gevaert, Kris; Martens, Lennart

2010-03-01

MS-based proteomics produces large amounts of mass spectra that require processing, identification and possibly quantification before interpretation can be undertaken. High-throughput studies require automation of these various steps, and management of the data in association with the results obtained. We here present ms_lims (http://genesis.UGent.be/ms_lims), a freely available, open-source system based on a central database to automate data management and processing in MS-driven proteomics analyses.

Laboratory medicine: challenges and opportunities.

PubMed

Bossuyt, Xavier; Verweire, Kurt; Blanckaert, Norbert

2007-10-01

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.

Nurse-driven, protocol-directed weaning from mechanical ventilation improves clinical outcomes and is well accepted by intensive care unit physicians.

PubMed

Danckers, Mauricio; Grosu, Horiana; Jean, Raymonde; Cruz, Raul B; Fidellaga, Amelita; Han, Qifa; Awerbuch, Elizabeth; Jadhav, Nagesh; Rose, Keith; Khouli, Hassan

2013-08-01

Ventilator weaning protocols can improve clinical outcomes, but their impact may vary depending on intensive care unit (ICU) structure, staffing, and acceptability by ICU physicians. This study was undertaken to examine their relationship. We prospectively examined outcomes of 102 mechanically ventilated patients for more than 24 hours and weaned using nurse-driven protocol-directed approach (nurse-driven group) in an intensivist-led ICU with low respiratory therapist staffing and compared them with a historic control of 100 patients who received conventional physician-driven weaning (physician-driven group). We administered a survey to assess ICU physicians' attitude. Median durations of mechanical ventilation (MV) in the nurse-driven and physician-driven groups were 2 and 4 days, respectively (P = .001). Median durations of ICU length of stay (LOS) in the nurse-driven and physician-driven groups were 5 and 7 days, respectively (P = .01). Time of extubation was 2 hours and 13 minutes earlier in the nurse-driven group (P < .001). There was no difference in hospital LOS, hospital mortality, rates of ventilator-associated pneumonia, or reintubation rates between the 2 groups. We identified 4 independent predictors of weaning duration: nurse-driven weaning, Acute Physiology and Chronic Health Evaluation II score, vasoactive medications use, and blood transfusion. Intensive care unit physicians viewed this protocol implementation positively (mean scores, 1.59-1.87 on a 5-point Likert scale). A protocol for liberation from MV driven by ICU nurses decreased the duration of MV and ICU LOS in mechanically ventilated patients for more than 24 hours without adverse effects and was well accepted by ICU physicians. Copyright © 2013 Elsevier Inc. All rights reserved.

Factors influencing clinical trial site selection in Europe: the Survey of Attitudes towards Trial sites in Europe (the SAT-EU Study).

PubMed

Gehring, Marta; Taylor, Rod S; Mellody, Marie; Casteels, Brigitte; Piazzi, Angela; Gensini, Gianfranco; Ambrosio, Giuseppe

2013-11-15

Applications to run clinical trials in Europe fell 25% between 2007 and 2011. Costs, speed of approvals and shortcomings of European Clinical Trial Directive are commonly invoked to explain this unsatisfactory performance. However, no hard evidence is available on the actual weight of these factors or has it been previously investigated whether other criteria may also impact clinical trial site selection. The Survey of Attitudes towards Trial sites in Europe (SAT-EU Study) was an anonymous, cross-sectional web-based survey that systematically assessed factors impacting European clinical trial site selection. It explored 19 factors across investigator-driven, hospital-driven and environment-driven criteria, and costs. It also surveyed perceptions of the European trial environment. Clinical research organisations (CROs), academic clinical trial units (CTUs) and industry invited to respond. weight assigned to each factor hypothesised to impact trial site selection and trial incidence. Secondary outcome: desirability of European countries to run clinical trials. Responses were obtained from 485 professionals in 34 countries: 49% from BioPharma, 40% from CTUs or CROs. Investigator-dependent, environment-dependent and hospital-dependent factors were rated highly important, costs being less important (p<0.0001). Within environment-driven criteria, pool of eligible patients, speed of approvals and presence of disease-management networks were significantly more important than costs or government financial incentives (p<0.0001). The pattern of response was consistent across respondent groupings (CTU vs CRO vs industry). Considerable variability was demonstrated in the perceived receptivity of countries to undertake clinical trials, with Germany, the UK and the Netherlands rated the best trial markets (p<0.0001). Investigator-dependent factors and ease of approval dominate trial site selection, while costs appear less important. Fostering competitiveness of European clinical research may not require additional government spending/incentives. Rather, harmonisation of approval processes, greater visibility of centres of excellence and reduction of 'hidden' indirect costs, may bring significantly more clinical trials to Europe.

The International Glossary on Infertility and Fertility Care, 2017.

PubMed

Zegers-Hochschild, Fernando; Adamson, G David; Dyer, Silke; Racowsky, Catherine; de Mouzon, Jacques; Sokol, Rebecca; Rienzi, Laura; Sunde, Arne; Schmidt, Lone; Cooke, Ian D; Simpson, Joe Leigh; van der Poel, Sheryl

2017-09-01

Can a consensus and evidence-driven set of terms and definitions be generated to be used globally in order to ensure consistency when reporting on infertility issues and fertility care interventions, as well as to harmonize communication among the medical and scientific communities, policy-makers, and lay public including individuals and couples experiencing fertility problems? A set of 283 consensus-based and evidence-driven terminologies used in infertility and fertility care has been generated through an inclusive consensus-based process with multiple stakeholders. In 2006 the International Committee for Monitoring Assisted Reproductive Technologies (ICMART) published a first glossary of 53 terms and definitions. In 2009 ICMART together with WHO published a revised version expanded to 87 terms, which defined infertility as a disease of the reproductive system, and increased standardization of fertility treatment terminology. Since 2009, limitations were identified in several areas and enhancements were suggested for the glossary, especially concerning male factor, demography, epidemiology and public health issues. Twenty-five professionals, from all parts of the world and representing their expertise in a variety of sub-specialties, were organized into five working groups: clinical definitions; outcome measurements; embryology laboratory; clinical and laboratory andrology; and epidemiology and public health. Assessment for revisions, as well as expansion on topics not covered by the previous glossary, were undertaken. A larger group of independent experts and representatives from collaborating organizations further discussed and assisted in refining all terms and definitions. Members of the working groups and glossary co-ordinators interacted through electronic mail and face-to-face in international/regional conferences. Two formal meetings were held in Geneva, Switzerland, with a final consensus meeting including independent experts as well as observers and representatives of international/regional scientific and patient organizations. A consensus-based and evidence-driven set of 283 terminologies used in infertility and fertility care was generated to harmonize communication among health professionals and scientists as well as the lay public, patients and policy makers. Definitions such as 'fertility care' and 'fertility awareness' together with terminologies used in embryology and andrology have been introduced in the glossary for the first time. Furthermore, the definition of 'infertility' has been expanded in order to cover a wider spectrum of conditions affecting the capacity of individuals and couples to reproduce. The definition of infertility remains as a disease characterized by the failure to establish a clinical pregnancy; however, it also acknowledges that the failure to become pregnant does not always result from a disease, and therefore introduces the concept of an impairment of function which can lead to a disability. Additionally, subfertility is now redundant, being replaced by the term infertility so as to standardize the definition and avoid confusion. All stakeholders agreed to the vast majority of terminologies included in this glossary. In cases where disagreements were not resolved, the final decision was reached after a vote, defined before the meeting as consensus if passed with 75%. Over the following months, an external expert group, which included representatives from non-governmental organizations, reviewed and provided final feedback on the glossary. Some terminologies have different definitions, depending on the area of medicine, for example demographic or clinical as well as geographic differences. These differences were taken into account and this glossary represents a multinational effort to harmonize terminologies that should be used worldwide. None. N/A. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

The International Glossary on Infertility and Fertility Care, 2017.

PubMed

Zegers-Hochschild, Fernando; Adamson, G David; Dyer, Silke; Racowsky, Catherine; de Mouzon, Jacques; Sokol, Rebecca; Rienzi, Laura; Sunde, Arne; Schmidt, Lone; Cooke, Ian D; Simpson, Joe Leigh; van der Poel, Sheryl

2017-09-01

Can a consensus and evidence-driven set of terms and definitions be generated to be used globally in order to ensure consistency when reporting on infertility issues and fertility care interventions, as well as to harmonize communication among the medical and scientific communities, policy-makers, and lay public including individuals and couples experiencing fertility problems? A set of 283 consensus-based and evidence-driven terminologies used in infertility and fertility care has been generated through an inclusive consensus-based process with multiple stakeholders. In 2006 the International Committee for Monitoring Assisted Reproductive Technologies (ICMART) published a first glossary of 53 terms and definitions. In 2009 ICMART together with WHO published a revised version expanded to 87 terms, which defined infertility as a disease of the reproductive system, and increased standardization of fertility treatment terminology. Since 2009, limitations were identified in several areas and enhancements were suggested for the glossary, especially concerning male factor, demography, epidemiology and public health issues. Twenty-five professionals, from all parts of the world and representing their expertise in a variety of sub-specialties, were organized into five working groups: clinical definitions; outcome measurements; embryology laboratory; clinical and laboratory andrology; and epidemiology and public health. Assessment for revisions, as well as expansion on topics not covered by the previous glossary, were undertaken. A larger group of independent experts and representatives from collaborating organizations further discussed and assisted in refining all terms and definitions. Members of the working groups and glossary co-ordinators interacted through electronic mail and face-to-face in international/regional conferences. Two formal meetings were held in Geneva, Switzerland, with a final consensus meeting including independent experts as well as observers and representatives of international/regional scientific and patient organizations. A consensus-based and evidence-driven set of 283 terminologies used in infertility and fertility care was generated to harmonize communication among health professionals and scientists as well as the lay public, patients and policy makers. Definitions such as 'fertility care' and 'fertility awareness' together with terminologies used in embryology and andrology have been introduced in the glossary for the first time. Furthermore, the definition of 'infertility' has been expanded in order to cover a wider spectrum of conditions affecting the capacity of individuals and couples to reproduce. The definition of infertility remains as a disease characterized by the failure to establish a clinical pregnancy; however, it also acknowledges that the failure to become pregnant does not always result from a disease, and therefore introduces the concept of an impairment of function which can lead to a disability. Additionally, subfertility is now redundant, being replaced by the term infertility so as to standardize the definition and avoid confusion. All stakeholders agreed to the vast majority of terminologies included in this glossary. In cases where disagreements were not resolved, the final decision was reached after a vote, defined before the meeting as consensus if passed with 75%. Over the following months, an external expert group, which included representatives from non-governmental organizations, reviewed and provided final feedback on the glossary. Some terminologies have different definitions, depending on the area of medicine, for example demographic or clinical as well as geographic differences. These differences were taken into account and this glossary represents a multinational effort to harmonize terminologies that should be used worldwide. None. N/A. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com

Model-Based Approach to Predict Adherence to Protocol During Antiobesity Trials.

PubMed

Sharma, Vishnu D; Combes, François P; Vakilynejad, Majid; Lahu, Gezim; Lesko, Lawrence J; Trame, Mirjam N

2018-02-01

Development of antiobesity drugs is continuously challenged by high dropout rates during clinical trials. The objective was to develop a population pharmacodynamic model that describes the temporal changes in body weight, considering disease progression, lifestyle intervention, and drug effects. Markov modeling (MM) was applied for quantification and characterization of responder and nonresponder as key drivers of dropout rates, to ultimately support the clinical trial simulations and the outcome in terms of trial adherence. Subjects (n = 4591) from 6 Contrave ® trials were included in this analysis. An indirect-response model developed by van Wart et al was used as a starting point. Inclusion of drug effect was dose driven using a population dose- and time-dependent pharmacodynamic (DTPD) model. Additionally, a population-pharmacokinetic parameter- and data (PPPD)-driven model was developed using the final DTPD model structure and final parameter estimates from a previously developed population pharmacokinetic model based on available Contrave ® pharmacokinetic concentrations. Last, MM was developed to predict transition rate probabilities among responder, nonresponder, and dropout states driven by the pharmacodynamic effect resulting from the DTPD or PPPD model. Covariates included in the models and parameters were diabetes mellitus and race. The linked DTPD-MM and PPPD-MM was able to predict transition rates among responder, nonresponder, and dropout states well. The analysis concluded that body-weight change is an important factor influencing dropout rates, and the MM depicted that overall a DTPD model-driven approach provides a reasonable prediction of clinical trial outcome probabilities similar to a pharmacokinetic-driven approach. © 2017, The Authors. The Journal of Clinical Pharmacology published by Wiley Periodicals, Inc. on behalf of American College of Clinical Pharmacology.

Wage increases in the clinical laboratory: how are workers faring against inflation and in comparison to other health professions?

PubMed

Chapman, Susan A; McClory, Vasey; Ward-Cook, Kory

2005-07-26

High vacancy rates in the clinical laboratory profession have led to the use of wage increases and financial incentives to attract and retain workers. American Society for Clinical Pathology (ASCP) surveys indicate that wages for Medical Technologists and Medical Laboratory Technicians have been steadily rising in the past few years following years of little or no increases. When adjusted for inflation, the real wage increases have even modestly exceeded the inflation rate. However, wages in the clinical laboratory remain lower than in several other allied health professions with comparable educational preparation. Achieving competitive wages will be important in addressing the long-term need to attract more students to the clinical laboratory.

The Accreditation Experience of Clinical Laboratories and Blood Banks in Mexico.

PubMed

Quintana, Sandra

2015-11-01

The accreditation of clinical laboratories and blood banks based on ISO 15189 is now being consolidated in Mexico, and is coordinated by the Mexican accreditation entity innovative strategies, A.C. (ema) and supported by the activities of the committee of clinical laboratories and blood banks. The active participation in working groups formed by the technical committee of clinical laboratories and blood banks in specific areas, has contributed to the formulation of technical documents and criteria of evaluation that strengthen the current accreditation scheme. The national registry of evaluation (PNE) consists of technical experts and evaluators from different disciplines of clinical laboratory; the evaluators actively participate in accreditation assessment, with an ultimate goal to receive training and feedback for continuous improvement of its own performance.

Survey of Laboratories and Implementation of the Federal Defense Laboratory Diversification Program. Annex A. Department of the Army Domestic Technology Transfer

DTIC Science & Technology

1993-11-01

Recover Nitramine (Yxidizers from Solid Propellants Using Liquid Ammonia * Co~ial Engine for Ducted Hybrid , and Gel BI-propu~uion Systems S ltravolet...Surface Optical Testing Device * Electron Beam Driven Negative Ion Source * Method of Manufacturing Hybrid Fber-Reinforced Composite Nozzle Materials...Modeling Software FRED Partner I ty * Class VDrnng Simulation Parow. Academia * Combustion and Tribology Partne. Academia * Hybrid Electric Drive/High

Writing to Learn by Learning to Write during the School Science Laboratory: Helping Middle and High School Students Develop Argumentative Writing Skills as They Learn Core Ideas

ERIC Educational Resources Information Center

Sampson, Victor; Enderle, Patrick; Grooms, Jonathon; Witte, Shelbie

2013-01-01

This study examined how students' science-specific argumentative writing skills and understanding of core ideas changed over the course of a school year as they participated in a series of science laboratories designed using the Argument-Driven Inquiry (ADI) instructional model. The ADI model is a student-centered and writing-intensive approach to…

Promoting Good Clinical Laboratory Practices and Laboratory Accreditation to Support Clinical Trials in Sub-Saharan Africa

PubMed Central

Shott, Joseph P.; Saye, Renion; Diakité, Moussa L.; Sanogo, Sintry; Dembele, Moussa B.; Keita, Sekouba; Nagel, Mary C.; Ellis, Ruth D.; Aebig, Joan A.; Diallo, Dapa A.; Doumbo, Ogobara K.

2012-01-01

Laboratory capacity in the developing world frequently lacks quality management systems (QMS) such as good clinical laboratory practices, proper safety precautions, and adequate facilities; impacting the ability to conduct biomedical research where it is needed most. As the regulatory climate changes globally, higher quality laboratory support is needed to protect study volunteers and to accurately assess biological parameters. The University of Bamako and its partners have undertaken a comprehensive QMS plan to improve quality and productivity using the Clinical and Laboratory Standards Institute standards and guidelines. The clinical laboratory passed the College of American Pathologists inspection in April 2010, and received full accreditation in June 2010. Our efforts to implement high-quality standards have been valuable for evaluating safety and immunogenicity of malaria vaccine candidates in Mali. Other disease-specific research groups in resource-limited settings may benefit by incorporating similar training initiatives, QMS methods, and continual improvement practices to ensure best practices. PMID:22492138

Clinical laboratory waste management in Shiraz, Iran.

PubMed

Askarian, Mehrdad; Motazedian, Nasrin; Palenik, Charles John

2012-06-01

Clinical laboratories are significant generators of infectious waste, including microbiological materials, contaminated sharps, and pathologic wastes such as blood specimens and blood products. Most waste produced in laboratories can be disposed of in the general solid waste stream. However, improper management of infectious waste, including mixing general wastes with infectious wastes and improper handling or storage, could lead to disease transmission. The aim of this study was to assess waste management processes used at clinical laboratories in Shiraz, Iran. One hundred and nine clinical laboratories participated In this cross sectional study, Data collection was by questionnaire and direct observation. Of the total amount of waste generated, 52% (by weight) was noninfectious domestic waste, 43% was non-sharps infectious waste and 5% consisted of sharps. There was no significant relationship between laboratory staff or manager education and the score for quality of waste collection and disposal at clinical laboratories. Improvements in infectious waste management processes should involve clearer, more uniformly accepted definitions of infectious waste and increased staff training.

Quality in the molecular microbiology laboratory.

PubMed

Wallace, Paul S; MacKay, William G

2013-01-01

In the clinical microbiology laboratory advances in nucleic acid detection, quantification, and sequence analysis have led to considerable improvements in the diagnosis, management, and monitoring of infectious diseases. Molecular diagnostic methods are routinely used to make clinical decisions based on when and how to treat a patient as well as monitor the effectiveness of a therapeutic regime and identify any potential drug resistant strains that may impact on the long term patient treatment program. Therefore, confidence in the reliability of the result provided by the laboratory service to the clinician is essential for patient treatment. Hence, suitable quality assurance and quality control measures are important to ensure that the laboratory methods and service meet the necessary regulatory requirements both at the national and international level. In essence, the modern clinical microbiology laboratory ensures the appropriateness of its services through a quality management system that monitors all aspects of the laboratory service pre- and post-analytical-from patient sample receipt to reporting of results, from checking and upholding staff competency within the laboratory to identifying areas for quality improvements within the service offered. For most European based clinical microbiology laboratories this means following the common International Standard Organization (ISO9001) framework and ISO15189 which sets out the quality management requirements for the medical laboratory (BS EN ISO 15189 (2003) Medical laboratories-particular requirements for quality and competence. British Standards Institute, Bristol, UK). In the United States clinical laboratories performing human diagnostic tests are regulated by the Centers for Medicare and Medicaid Services (CMS) following the requirements within the Clinical Laboratory Improvement Amendments document 1988 (CLIA-88). This chapter focuses on the key quality assurance and quality control requirements within the modern microbiology laboratory providing molecular diagnostics.

76 FR 39879 - Clinical Laboratory Improvement Advisory Committee (CLIAC)

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Clinical Laboratory Improvement Advisory Committee (CLIAC) In accordance with section 10(a)(2) of the Federal Advisory... the nature of, revisions to the standards under which clinical laboratories are regulated; the impact...

75 FR 39028 - Clinical Laboratory Improvement Advisory Committee (CLIAC)

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Clinical Laboratory Improvement Advisory Committee (CLIAC) In accordance with section 10(a)(2) of the Federal Advisory... to the standards under which clinical laboratories are regulated; the impact on medical and...

77 FR 14805 - Clinical Laboratory Improvement Advisory Committee, Centers for Disease Control and Prevention...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-13

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Clinical Laboratory Improvement Advisory Committee, Centers for Disease Control and Prevention: Notice of Charter..., that the Clinical Laboratory Improvement Advisory Committee, Centers for Disease Control and Prevention...

Quality in laboratory medicine: 50years on.

PubMed

Plebani, Mario

2017-02-01

The last 50years have seen substantial changes in the landscape of laboratory medicine: its role in modern medicine is in evolution and the quality of laboratory services is changing. The need to control and improve quality in clinical laboratories has grown hand in hand with the growth in technological developments leading to an impressive reduction of analytical errors over time. An essential cause of this impressive improvement has been the introduction and monitoring of quality indicators (QIs) such as the analytical performance specifications (in particular bias and imprecision) based on well-established goals. The evolving landscape of quality and errors in clinical laboratories moved first from analytical errors to all errors performed within the laboratory walls, subsequently to errors in laboratory medicine (including errors in test requesting and result interpretation), and finally, to a focus on errors more frequently associated with adverse events (laboratory-associated errors). After decades in which clinical laboratories have focused on monitoring and improving internal indicators of analytical quality, efficiency and productivity, it is time to shift toward indicators of total quality, clinical effectiveness and patient outcomes. Copyright © 2016 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Burkholderia pseudomallei: Challenges for the Clinical Microbiology Laboratory.

PubMed

Hemarajata, Peera; Baghdadi, Jonathan D; Hoffman, Risa; Humphries, Romney M

2016-12-01

Melioidosis is a potentially fatal infection caused by the bacterium Burkholderia pseudomallei Clinical diagnosis of melioidosis can be challenging since there is no pathognomonic clinical syndrome, and the organism is often misidentified by methods used routinely in clinical laboratories. Although the disease is more prevalent in Thailand and northern Australia, sporadic cases may be encountered in areas where it is not endemic, including the United States. Since the organism is considered a tier 1 select agent according to the Centers for Disease Control and Prevention and the U.S. Department of Agriculture Animal and Plant Health Inspection Service, clinical laboratories must be proficient at rapidly recognizing isolates suspicious for B. pseudomallei, be able to safely perform necessary rule-out tests, and to refer suspect isolates to Laboratory Response Network reference laboratories. In this minireview, we report a case of melioidosis encountered at our institution and discuss the laboratory challenges encountered when dealing with clinical isolates suspicious for B. pseudomallei or clinical specimens from suspected melioidosis cases. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

Automation in the clinical microbiology laboratory.

PubMed

Novak, Susan M; Marlowe, Elizabeth M

2013-09-01

Imagine a clinical microbiology laboratory where a patient's specimens are placed on a conveyor belt and sent on an automation line for processing and plating. Technologists need only log onto a computer to visualize the images of a culture and send to a mass spectrometer for identification. Once a pathogen is identified, the system knows to send the colony for susceptibility testing. This is the future of the clinical microbiology laboratory. This article outlines the operational and staffing challenges facing clinical microbiology laboratories and the evolution of automation that is shaping the way laboratory medicine will be practiced in the future. Copyright © 2013 Elsevier Inc. All rights reserved.

Properties and Units in the Clinical Laboratory Sciences. IX. Properties and Units in Trace Elements (IUPAC-IFCC Technical report 1997). International Union of Pure and Applied Chemistry and International Federation of Clinical Chemistry. rita.cornelis@rug.ac.be.

PubMed

Cornelis, R; Fuentes-Arderiu, X; Bruunshuus, I; Templeton, D

1997-12-10

This document is the first recommendation on the presentation of trace elements and their values in clinical laboratory sciences from IFCC and IUPAC. It forms part of the ongoing effort to standardize requests and reporting of laboratory data for transmission across cultural and linguistic domains, without attempting to standardize the language used by clinicians and laboratory practitioners. Subsequent documents deal with syntax, kinds-of-property, and properties and units used in other areas of clinical laboratory sciences.

Teaching pediatric laboratory medicine to pathology residents.

PubMed

Pysher, Theodore J; Bach, Philip R; Geaghan, Sharon M; Hamilton, Marilyn S; Laposata, Michael; Lockitch, Gillian; Brugnara, Carlo; Coffin, Cheryl M; Pasquali, Marzia; Rinaldo, Piero; Roberts, William L; Rutledge, Joe C; Ashwood, Edward R; Blaylock, Robert C; Campos, Joseph M; Goldsmith, Barbara; Jones, Patricia M; Lim, Megan; Meikle, A Wayne; Perkins, Sherrie L; Perry, Deborah A; Petti, Cathy A; Rogers, Beverly B; Steele, Paul E; Weiss, Ronald L; Woods, Gail

2006-07-01

Laboratory data are essential to the medical care of fetuses, infants, children, and adolescents. However, the performance and interpretation of laboratory tests on specimens from these patients, which may constitute a significant component of the workload in general hospitals and integrated health care systems as well as specialized perinatal or pediatric centers, present unique challenges to the clinical pathologist and the laboratory. Therefore, pathology residents should receive training in pediatric laboratory medicine. Children's Health Improvement through Laboratory Diagnostics, a group of pathologists and laboratory scientists with interest and expertise in pediatric laboratory medicine, convened a task force to develop a list of curriculum topics, key resources, and training experiences in pediatric laboratory medicine for trainees in anatomic and clinical pathology or straight clinical pathology residency programs and in pediatric pathology fellowship programs. Based on the experiences of 11 training programs, we have compiled a comprehensive list of pediatric topics in the areas of clinical chemistry, endocrinology, hematology, urinalysis, coagulation medicine, transfusion medicine, immunology, microbiology and virology, biochemical genetics, cytogenetics and molecular diagnostics, point of care testing, and laboratory management. This report also includes recommendations for training experiences and a list of key texts and other resources in pediatric laboratory medicine. Clinical pathologists should be trained to meet the laboratory medicine needs of pediatric patients and to assist the clinicians caring for these patients with the selection and interpretation of laboratory studies. This review helps program directors tailor their curricula to more effectively provide this training.

New technology for ultrasensitive detection and isolation of rare cells for clinical diagnostics and therapeutics

NASA Astrophysics Data System (ADS)

Leary, James F.; McLaughlin, Scott R.

1995-04-01

A high-speed, 11-parameter, 6-color fluorescence, laser flow cytometer/cell sorter with a number of special and unique features has been built for ultrasensitive detection and isolation of rare cells for clinical diagnostics and therapeutics. The software for real-time data acquisition and sort control, written as C++ programming language modules with a WindowsTM graphical user interface, runs on a 66-MHz 80486 computer joined by an extended bus to 23 sophisticated multi-layered boards of special data acquisition and sorting electronics. Special features include: high-speed (> 100,000 cells/sec) real-time data classification module (U.S. Patent 5,204,884 (1993)); real-time principal component cell sorting; multi-queue signal-processing system with multiple hardware and software event buffers to reduce instrument dead time, LUT charge-pulse definition, high-resolution `flexible' sorting for optimal yield/purity sort strategies (U.S. Patent 5,199,576); pre-focusing optical wavelength correction for a second laser beam; and two trains of three fluorescence detectors-- each adjustable for spatial separation to interrogate only one of two laser beams, syringe- driven or pressure-driven fluidics, and time-windowed parameters. The system has been built to be both expandable and versatile through the use of LUT's and a modular hardware and software design. The instrument is especially useful at detection and isolation of rare cell subpopulations for which our laboratory is well-known. Cell subpopulations at frequencies as small as 10-7 have been successfully studied with this system. Current applications in clinical diagnostics and therapeutics include detection and isolation of (1) fetal cells from material blood for prenatal diagnosis of birth defects, (2) hematopoietic stem and precursor cells for autologous bone marrow transplantation, (3) metastatic breast cancer cells for molecular characterization, and (4) HIV-infected maternal cells in newborn blood to study mother-to-infant vertical transmission of AIDS.

The continued value of disk diffusion for assessing antimicrobial susceptibility in clinical laboratories: report from the Clinical and Laboratory Standards Institute Methods Development and Standardization Working Group.

PubMed

Humphries, Romney M; Kircher, Susan; Ferrell, Andrea; Krause, Kevin M; Malherbe, Rianna; Hsiung, Andre; Burnham, C A

2018-05-09

Expedited pathways to antimicrobial agent approval by the United States Food and Drug Administration (FDA) have led to increased delays between drug approval and the availability of FDA-cleared antimicrobial susceptibility testing (AST) devices. Antimicrobial disks for use with disk diffusion testing are among the first AST devices available to clinical laboratories. However, many laboratories are reluctant to implement a disk diffusion method for a variety of reasons, including dwindling proficiency with this method, interruptions to laboratory workflow, uncertainty surrounding the quality and reliability of a disk diffusion test, and perceived need to report an MIC to clinicians. This mini-review provides a report from the Clinical and Laboratory Standards Institute Working Group on Methods Development and Standardization on the current standards and clinical utility of disk diffusion testing. Copyright © 2018 American Society for Microbiology.

Guidelines on Good Clinical Laboratory Practice

PubMed Central

Ezzelle, J.; Rodriguez-Chavez, I. R.; Darden, J. M.; Stirewalt, M.; Kunwar, N.; Hitchcock, R.; Walter, T.; D’Souza, M. P.

2008-01-01

A set of Good Clinical Laboratory Practice (GCLP) standards that embraces both the research and clinical aspects of GLP were developed utilizing a variety of collected regulatory and guidance material. We describe eleven core elements that constitute the GCLP standards with the objective of filling a gap for laboratory guidance, based on IND sponsor requirements, for conducting laboratory testing using specimens from human clinical trials. These GCLP standards provide guidance on implementing GLP requirements that are critical for laboratory operations, such as performance of protocol-mandated safety assays, peripheral blood mononuclear cell processing and immunological or endpoint assays from biological interventions on IND-registered clinical trials. The expectation is that compliance with the GCLP standards, monitored annually by external audits, will allow research and development laboratories to maintain data integrity and to provide immunogenicity, safety, and product efficacy data that is repeatable, reliable, auditable and that can be easily reconstructed in a research setting. PMID:18037599

A Concept of Cross-Ferroic Plasma Turbulence

PubMed Central

Inagaki, S.; Kobayashi, T.; Kosuga, Y.; Itoh, S.-I.; Mitsuzono, T.; Nagashima, Y.; Arakawa, H.; Yamada, T.; Miwa, Y.; Kasuya, N.; Sasaki, M.; Lesur, M.; Fujisawa, A.; Itoh, K.

2016-01-01

The variety of scalar and vector fields in laboratory and nature plasmas is formed by plasma turbulence. Drift-wave fluctuations, driven by density gradients in magnetized plasmas, are known to relax the density gradient while they can generate flows. On the other hand, the sheared flow in the direction of magnetic fields causes Kelvin-Helmholtz type instabilities, which mix particle and momentum. These different types of fluctuations coexist in laboratory and nature, so that the multiple mechanisms for structural formation exist in extremely non-equilibrium plasmas. Here we report the discovery of a new order in plasma turbulence, in which chained structure formation is realized by cross-interaction between inhomogeneities of scalar and vector fields. The concept of cross-ferroic turbulence is developed, and the causal relation in the multiple mechanisms behind structural formation is identified, by measuring the relaxation rate and dissipation power caused by the complex turbulence-driven flux. PMID:26917218

Dehydration-driven stress transfer triggers intermediate-depth earthquakes

NASA Astrophysics Data System (ADS)

Ferrand, Thomas P.; Hilairet, Nadège; Incel, Sarah; Deldicque, Damien; Labrousse, Loïc; Gasc, Julien; Renner, Joerg; Wang, Yanbin; Green, Harry W., II; Schubnel, Alexandre

2017-05-01

Intermediate-depth earthquakes (30-300 km) have been extensively documented within subducting oceanic slabs, but their mechanics remains enigmatic. Here we decipher the mechanism of these earthquakes by performing deformation experiments on dehydrating serpentinized peridotites (synthetic antigorite-olivine aggregates, minerals representative of subduction zones lithologies) at upper mantle conditions. At a pressure of 1.1 gigapascals, dehydration of deforming samples containing only 5 vol% of antigorite suffices to trigger acoustic emissions, a laboratory-scale analogue of earthquakes. At 3.5 gigapascals, acoustic emissions are recorded from samples with up to 50 vol% of antigorite. Experimentally produced faults, observed post-mortem, are sealed by fluid-bearing micro-pseudotachylytes. Microstructural observations demonstrate that antigorite dehydration triggered dynamic shear failure of the olivine load-bearing network. These laboratory analogues of intermediate-depth earthquakes demonstrate that little dehydration is required to trigger embrittlement. We propose an alternative model to dehydration-embrittlement in which dehydration-driven stress transfer, rather than fluid overpressure, causes embrittlement.

Spontaneous and induced tolerance for liver transplant recipients.

PubMed

Feng, Sandy

2016-02-01

Transformative medical and surgical advances have remarkably improved short-term survival after liver transplantation. There is, however, pervasive concern that the cumulative toxicities of modern immunosuppression regimens severely compromise both quality and quantity of life for liver transplant recipients. The inherently tolerogenic nature of the liver offers the tantalizing opportunity to change the current paradigm of nonspecific and lifelong immunosuppression. Safe minimization or discontinuation of immunosuppression without damage to the liver allograft is an attractive strategy to improve long-term survival after liver transplantation. Recent prospective, multicenter clinical trials have demonstrated that immunosuppression can be safely withdrawn from selected liver transplant recipients with preservation of allograft histology. These successes have spurred multiple avenues of investigation to identify peripheral blood and/or tissue biomarkers and delineate mechanisms of tolerance. Concomitant advances in the ability to expand regulatory T cells in the laboratory have spawned clinical trials to facilitate immunosuppression minimization and/or discontinuation. This review will delineate the unique liver immunobiology that has driven the recent clinical trials to unmask spontaneous tolerance or induce tolerance for liver transplant recipients. The emerging results of these trials over the next 5 years hold promise to reduce the burden of lifelong immunosuppression and thereby optimize the long-term health of liver transplant recipients.

The trauma film paradigm as an experimental psychopathology model of psychological trauma: intrusive memories and beyond.

PubMed

James, Ella L; Lau-Zhu, Alex; Clark, Ian A; Visser, Renée M; Hagenaars, Muriel A; Holmes, Emily A

2016-07-01

A better understanding of psychological trauma is fundamental to clinical psychology. Following traumatic event(s), a clinically significant number of people develop symptoms, including those of Acute Stress Disorder and/or Post Traumatic Stress Disorder. The trauma film paradigm offers an experimental psychopathology model to study both exposure and reactions to psychological trauma, including the hallmark symptom of intrusive memories. We reviewed 74 articles that have used this paradigm since the earliest review (Holmes & Bourne, 2008) until July 2014. Highlighting the different stages of trauma processing, i.e. pre-, peri- and post-trauma, the studies are divided according to manipulations before, during and after film viewing, for experimental as well as correlational designs. While the majority of studies focussed on the frequency of intrusive memories, other reactions to trauma were also modelled. We discuss the strengths and weaknesses of the trauma film paradigm as an experimental psychopathology model of trauma, consider ethical issues, and suggest future directions. By understanding the basic mechanisms underlying trauma symptom development, we can begin to translate findings from the laboratory to the clinic, test innovative science-driven interventions, and in the future reduce the debilitating effects of psychopathology following stressful and/or traumatic events. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Best way to revascularize patients with main stem and three vessel lesions: patients should undergo PCI!

PubMed

Schächinger, Volker; Herdeg, Christian; Scheller, Bruno

2010-09-01

The optimal revascularization strategy for multivessel disease is under controversial discussion for long time. Until now, technical innovations have been faster than performance of clinical trials, making results of randomized studies outdated at the time of appearance. Recently, the SYNTAX trial has been published, which compared drug elutings stents (DES) implantation with Coronary artery bypass graft (CABG) patients with multivessel or left main disease in a clinically stable population. Overall, CABG was superior with respect to the clinical endpoint of death, myocardial infarction, stroke, or revascularization. However, the difference is driven by the "weakest" end point, namely repeated revascularization, whereas combined "hard" events did not demonstrate a difference. More detailed analysis demonstrates that only patients with most complex coronary anatomy gain definite benefit from CABG. In addition, SYNTAX demonstrated that left main disease is no longer a domain of CABG, since DES implantation revealed comparable results, as long as there is no concomitant multivessel disease. Regardless the results of SYNTAX, one should not forget that SYNTAX represents only a minority of daily patients in a catheterization laboratory, excluding patients with one- or two-vessel disease and those with an acute coronary syndrome. Especially in the latter, percutaneous coronary intervention has demonstrated to improve prognosis.

Data-Driven Asthma Endotypes Defined from Blood Biomarker and Gene Expression Data

PubMed Central

George, Barbara Jane; Reif, David M.; Gallagher, Jane E.; Williams-DeVane, ClarLynda R.; Heidenfelder, Brooke L.; Hudgens, Edward E.; Jones, Wendell; Neas, Lucas; Hubal, Elaine A. Cohen; Edwards, Stephen W.

2015-01-01

The diagnosis and treatment of childhood asthma is complicated by its mechanistically distinct subtypes (endotypes) driven by genetic susceptibility and modulating environmental factors. Clinical biomarkers and blood gene expression were collected from a stratified, cross-sectional study of asthmatic and non-asthmatic children from Detroit, MI. This study describes four distinct asthma endotypes identified via a purely data-driven method. Our method was specifically designed to integrate blood gene expression and clinical biomarkers in a way that provides new mechanistic insights regarding the different asthma endotypes. For example, we describe metabolic syndrome-induced systemic inflammation as an associated factor in three of the four asthma endotypes. Context provided by the clinical biomarker data was essential in interpreting gene expression patterns and identifying putative endotypes, which emphasizes the importance of integrated approaches when studying complex disease etiologies. These synthesized patterns of gene expression and clinical markers from our research may lead to development of novel serum-based biomarker panels. PMID:25643280

Challenges of Maintaining Good Clinical Laboratory Practices in Low-Resource Settings:  A Health Program Evaluation Framework Case Study From East Africa.

PubMed

Zhang, Helen L; Omondi, Michael W; Musyoka, Augustine M; Afwamba, Isaac A; Swai, Remigi P; Karia, Francis P; Muiruri, Charles; Reddy, Elizabeth A; Crump, John A; Rubach, Matthew P

2016-08-01

Using a clinical research laboratory as a case study, we sought to characterize barriers to maintaining Good Clinical Laboratory Practice (GCLP) services in a developing world setting. Using a US Centers for Disease Control and Prevention framework for program evaluation in public health, we performed an evaluation of the Kilimanjaro Christian Medical Centre-Duke University Health Collaboration clinical research laboratory sections of the Kilimanjaro Clinical Research Institute in Moshi, Tanzania. Laboratory records from November 2012 through October 2014 were reviewed for this analysis. During the 2-year period of study, seven instrument malfunctions suspended testing required for open clinical trials. A median (range) of 9 (1-55) days elapsed between instrument malfunction and biomedical engineer service. Sixteen (76.1%) of 21 suppliers of reagents, controls, and consumables were based outside Tanzania. Test throughput among laboratory sections used a median (range) of 0.6% (0.2%-2.7%) of instrument capacity. Five (55.6%) of nine laboratory technologists left their posts over 2 years. These findings demonstrate that GCLP laboratory service provision in this setting is hampered by delays in biomedical engineer support, delays and extra costs in commodity procurement, low testing throughput, and high personnel turnover. © American Society for Clinical Pathology, 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Selecting automation for the clinical chemistry laboratory.

PubMed

Melanson, Stacy E F; Lindeman, Neal I; Jarolim, Petr

2007-07-01

Laboratory automation proposes to improve the quality and efficiency of laboratory operations, and may provide a solution to the quality demands and staff shortages faced by today's clinical laboratories. Several vendors offer automation systems in the United States, with both subtle and obvious differences. Arriving at a decision to automate, and the ensuing evaluation of available products, can be time-consuming and challenging. Although considerable discussion concerning the decision to automate has been published, relatively little attention has been paid to the process of evaluating and selecting automation systems. To outline a process for evaluating and selecting automation systems as a reference for laboratories contemplating laboratory automation. Our Clinical Chemistry Laboratory staff recently evaluated all major laboratory automation systems in the United States, with their respective chemistry and immunochemistry analyzers. Our experience is described and organized according to the selection process, the important considerations in clinical chemistry automation, decisions and implementation, and we give conclusions pertaining to this experience. Including the formation of a committee, workflow analysis, submitting a request for proposal, site visits, and making a final decision, the process of selecting chemistry automation took approximately 14 months. We outline important considerations in automation design, preanalytical processing, analyzer selection, postanalytical storage, and data management. Selecting clinical chemistry laboratory automation is a complex, time-consuming process. Laboratories considering laboratory automation may benefit from the concise overview and narrative and tabular suggestions provided.

The universe of ANA testing: a case for point-of-care ANA testing.

PubMed

Konstantinov, Konstantin N; Rubin, Robert L

2017-12-01

Testing for total antinuclear antibodies (ANA) is a critical tool for diagnosis and management of autoimmune diseases at both the primary care and subspecialty settings. Repurposing of ANA from a test for lupus to a test for any autoimmune condition has driven the increase in ANA requests. Changes in ANA referral patterns include early or subclinical autoimmune disease detection in patients with low pre-test probability and use of negative ANA results to rule out underlying autoimmune disease. A positive result can lead to further diagnostic considerations. Currently, ANA tests are performed in centralized laboratories; an alternative would be ANA testing at the clinical point-of-care (POC). By virtue of its near real-time data collection capability, low cost, and ease of use, we believe the POC ANA has the potential to enable a new paradigm shift in autoimmune serology testing.

CPTAC Assay Portal: a repository of targeted proteomic assays

DOE Office of Scientific and Technical Information (OSTI.GOV)

Whiteaker, Jeffrey R.; Halusa, Goran; Hoofnagle, Andrew N.

2014-06-27

To address these issues, the Clinical Proteomic Tumor Analysis Consortium (CPTAC) of the National Cancer Institute (NCI) has launched an Assay Portal (http://assays.cancer.gov) to serve as a public repository of well-characterized quantitative, MS-based, targeted proteomic assays. The purpose of the CPTAC Assay Portal is to facilitate widespread adoption of targeted MS assays by disseminating SOPs, reagents, and assay characterization data for highly characterized assays. A primary aim of the NCI-supported portal is to bring together clinicians or biologists and analytical chemists to answer hypothesis-driven questions using targeted, MS-based assays. Assay content is easily accessed through queries and filters, enabling investigatorsmore » to find assays to proteins relevant to their areas of interest. Detailed characterization data are available for each assay, enabling researchers to evaluate assay performance prior to launching the assay in their own laboratory.« less

Surge capacity for response to bioterrorism in hospital clinical microbiology laboratories.

PubMed

Shapiro, Daniel S

2003-12-01

Surge capacity is the ability to rapidly mobilize to meet an increased demand. While large amounts of federal funding have been allocated to public health laboratories, little federal funding has been allocated to hospital microbiology laboratories. There are concerns that hospital laboratories may have inadequate surge capacities to deal with a significant bioterrorism incident. A workflow analysis of a clinical microbiology laboratory that serves an urban medical center was performed to identify barriers to surge capacity in the setting of a bioterrorism event and to identify solutions to these problems. Barriers include a national shortage of trained medical technologists, the inability of clinical laboratories to deal with a dramatic increase in the number of blood cultures, a delay while manufacturers increase production of critical products and then transport and deliver these products to clinical laboratories, and a shortage of class II biological safety cabinets. Federal funding could remedy staffing shortages by making the salaries of medical technologists comparable to those of similarly educated health care professionals and by providing financial incentives for students to enroll in clinical laboratory science programs. Blood culture bottles, and possibly continuous-monitoring blood culture instruments, should be added to the national antibiotic stockpile. Federal support must ensure that companies that manufacture essential laboratory supplies are capable of rapidly scaling up production. Hospitals must provide increased numbers of biological safety cabinets and amounts of space dedicated to clinical microbiology laboratories. Laboratories should undertake limited cross-training of technologists, ensure that adequate packaging supplies are available, and be able to move to a 4-day blood culture protocol.

[ISO 15189 accreditation in clinical microbiology laboratory: general concepts and the status in our laboratory].

PubMed

Akyar, Işin

2009-10-01

One important trend in the laboratory profession and quality management is the global convergence of laboratory operations. The goal of an accredited medical laboratory is to continue "offering useful laboratory service for diagnosis and treatment of the patients and also aid to the health of the nation". An accredited clinical laboratory is managed by a quality control system, it is competent technically and the laboratory service meets the needs of all its patients and physicians by taking the responsibility of all the medical tests and therapies. For this purpose, ISO 15189 international standard has been prepared by 2003. ISO 15189 standard is originated from the arrangement of ISO 17025 and ISO 9001:2000 standards. Many countries such as England, Germany, France, Canada and Australia have preferred ISO 15189 as their own laboratory accreditation programme, meeting all the requirements of their medical laboratories. The accreditation performance of a clinical microbiology laboratory is mainly based on five essential points; preanalytical, analytical, postanalytical, quality control programmes (internal, external, interlaboratory) and audits (internal, external). In this review article, general concepts on ISO 15189 accreditation standards for the clinical microbiology laboratories have been summarized and the status of a private laboratory (Acibadem LabMed, Istanbul) in Turkey has been discussed.

Clinical Laboratory Sciences: The Next Twenty Years.

ERIC Educational Resources Information Center

Morris, Frances J.

The views of professionals concerning the future of the clinical laboratory sciences were assessed using a modification of the Delphi technique. The participating administrators, educators, and bench technologists were asked what they felt the clinical laboratory sciences would be like in 20 years, and their responses were used to develop…

77 FR 64340 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-19

.... Information Collection Request Title: National Survey on Health Information Exchange in Clinical Laboratories... National Survey on Health Information Exchange in Clinical Laboratories will assess and evaluate the electronic transfer of health information from clinical laboratories to ordering physicians. It will focus on...

77 FR 6124 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-07

... collection. Title of Information Collection: Post Clinical Laboratory Survey Questionnaire and Supporting Regulations in 42 CFR 493.1771, 493.1773, and 493.1777. Use: Form CMS-668B is used by a Clinical Laboratory... Report Form for Clinical Laboratory Improvement Amendments (CLIA) and Supporting Regulations in 42 CFR...

The Accreditation Experience of Clinical Laboratories and Blood Banks in Mexico

PubMed Central

2015-01-01

The accreditation of clinical laboratories and blood banks based on ISO 15189 is now being consolidated in Mexico, and is coordinated by the Mexican accreditation entity innovative strategies, A.C. (ema) and supported by the activities of the committee of clinical laboratories and blood banks. The active participation in working groups formed by the technical committee of clinical laboratories and blood banks in specific areas, has contributed to the formulation of technical documents and criteria of evaluation that strengthen the current accreditation scheme. The national registry of evaluation (PNE) consists of technical experts and evaluators from different disciplines of clinical laboratory; the evaluators actively participate in accreditation assessment, with an ultimate goal to receive training and feedback for continuous improvement of its own performance. PMID:27683498

Development and Validation of Targeted Next-Generation Sequencing Panels for Detection of Germline Variants in Inherited Diseases.

PubMed

Santani, Avni; Murrell, Jill; Funke, Birgit; Yu, Zhenming; Hegde, Madhuri; Mao, Rong; Ferreira-Gonzalez, Andrea; Voelkerding, Karl V; Weck, Karen E

2017-06-01

- The number of targeted next-generation sequencing (NGS) panels for genetic diseases offered by clinical laboratories is rapidly increasing. Before an NGS-based test is implemented in a clinical laboratory, appropriate validation studies are needed to determine the performance characteristics of the test. - To provide examples of assay design and validation of targeted NGS gene panels for the detection of germline variants associated with inherited disorders. - The approaches used by 2 clinical laboratories for the development and validation of targeted NGS gene panels are described. Important design and validation considerations are examined. - Clinical laboratories must validate performance specifications of each test prior to implementation. Test design specifications and validation data are provided, outlining important steps in validation of targeted NGS panels by clinical diagnostic laboratories.

Impact of an Electronic Health Record-Integrated Personal Health Record on Patient Participation in Health Care: Development and Randomized Controlled Trial of MyHealthKeeper

PubMed Central

Ryu, Borim; Kim, Nari; Heo, Eunyoung; Yoo, Sooyoung; Lee, Keehyuck; Hwang, Hee; Kim, Jeong-Whun; Kim, Yoojung; Lee, Joongseek

2017-01-01

Background Personal health record (PHR)–based health care management systems can improve patient engagement and data-driven medical diagnosis in a clinical setting. Objective The purpose of this study was (1) to demonstrate the development of an electronic health record (EHR)–tethered PHR app named MyHealthKeeper, which can retrieve data from a wearable device and deliver these data to a hospital EHR system, and (2) to study the effectiveness of a PHR data-driven clinical intervention with clinical trial results. Methods To improve the conventional EHR-tethered PHR, we ascertained clinicians’ unmet needs regarding PHR functionality and the data frequently used in the field through a cocreation workshop. We incorporated the requirements into the system design and architecture of the MyHealthKeeper PHR module. We constructed the app and validated the effectiveness of the PHR module by conducting a 4-week clinical trial. We used a commercially available activity tracker (Misfit) to collect individual physical activity data, and developed the MyHealthKeeper mobile phone app to record participants’ patterns of daily food intake and activity logs. We randomly assigned 80 participants to either the PHR-based intervention group (n=51) or the control group (n=29). All of the study participants completed a paper-based survey, a laboratory test, a physical examination, and an opinion interview. During the 4-week study period, we collected health-related mobile data, and study participants visited the outpatient clinic twice and received PHR-based clinical diagnosis and recommendations. Results A total of 68 participants (44 in the intervention group and 24 in the control group) completed the study. The PHR intervention group showed significantly higher weight loss than the control group (mean 1.4 kg, 95% CI 0.9-1.9; P<.001) at the final week (week 4). In addition, triglyceride levels were significantly lower by the end of the study period (mean 2.59 mmol/L, 95% CI 17.6-75.8; P=.002). Conclusions We developed an innovative EHR-tethered PHR system that allowed clinicians and patients to share lifelog data. This study shows the effectiveness of a patient-managed and clinician-guided health tracker system and its potential to improve patient clinical profiles. Trial Registration ClinicalTrials.gov NCT03200119; https://clinicaltrials.gov/ct2/show/NCT03200119 (Archived by WebCite at http://www.webcitation.org/6v01HaCdd) PMID:29217503

[Proposal for graduate school education in the future: from the viewpoint of the Department of clinical Laboratory in a university hospital].

PubMed

Ishii, Junichi

2009-08-01

Fujita Health University Hospital, located in Toyoake, is a large teaching hospital with 1,505 beds. The Department of Clinical Laboratory in our hospital, in which 136 medical technologists work, is one of the largest clinical laboratories in Japan. Medical technologists in our hospital are required not only to perform accurate laboratory examinations, but also to contribute to the medical care team. In addition, they must educate students and trainee medical technologists. Furthermore, they conduct research to develop and evaluate new laboratory methods. Thus, we hope that education in graduate schools of medical technology (Master's course), along with promoting the specialty of laboratory techniques, will develop students' clinical skills to examine patients and research skills to conduct studies.

[Software for illustrating a cost-quality balance carried out by clinical laboratory practice].

PubMed

Nishibori, Masahiro; Asayama, Hitoshi; Kimura, Satoshi; Takagi, Yasushi; Hagihara, Michio; Fujiwara, Mutsunori; Yoneyama, Akiko; Watanabe, Takashi

2010-09-01

We have no proper reference indicating the quality of clinical laboratory practice, which should clearly illustrates that better medical tests require more expenses. Japanese Society of Laboratory Medicine was concerned about recent difficult medical economy and issued a committee report proposing a guideline to evaluate the good laboratory practice. According to the guideline, we developed software that illustrate a cost-quality balance carried out by clinical laboratory practice. We encountered a number of controversial problems, for example, how to measure and weight each quality-related factor, how to calculate costs of a laboratory test and how to consider characteristics of a clinical laboratory. Consequently we finished only prototype software within the given period and the budget. In this paper, software implementation of the guideline and the above-mentioned problems are summarized. Aiming to stimulate these discussions, the operative software will be put on the Society's homepage for trial

ASVCP quality assurance guidelines: control of general analytical factors in veterinary laboratories.

PubMed

Flatland, Bente; Freeman, Kathy P; Friedrichs, Kristen R; Vap, Linda M; Getzy, Karen M; Evans, Ellen W; Harr, Kendal E

2010-09-01

Owing to lack of governmental regulation of veterinary laboratory performance, veterinarians ideally should demonstrate a commitment to self-monitoring and regulation of laboratory performance from within the profession. In response to member concerns about quality management in veterinary laboratories, the American Society for Veterinary Clinical Pathology (ASVCP) formed a Quality Assurance and Laboratory Standards (QAS) committee in 1996. This committee recently published updated and peer-reviewed Quality Assurance Guidelines on the ASVCP website. The Quality Assurance Guidelines are intended for use by veterinary diagnostic laboratories and veterinary research laboratories that are not covered by the US Food and Drug Administration Good Laboratory Practice standards (Code of Federal Regulations Title 21, Chapter 58). The guidelines have been divided into 3 reports on 1) general analytic factors for veterinary laboratory performance and comparisons, 2) hematology and hemostasis, and 3) clinical chemistry, endocrine assessment, and urinalysis. This report documents recommendations for control of general analytical factors within veterinary clinical laboratories and is based on section 2.1 (Analytical Factors Important In Veterinary Clinical Pathology, General) of the newly revised ASVCP QAS Guidelines. These guidelines are not intended to be all-inclusive; rather, they provide minimum guidelines for quality assurance and quality control for veterinary laboratory testing. It is hoped that these guidelines will provide a basis for laboratories to assess their current practices, determine areas for improvement, and guide continuing professional development and education efforts. ©2010 American Society for Veterinary Clinical Pathology.

42 CFR 493.1405 - Standard; Laboratory director qualifications.

Code of Federal Regulations, 2010 CFR

2010-10-01

... degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution... Chemistry, the American Board of Bioanalysis, or the American Board of Medical Laboratory Immunology; or (ii...) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or...

42 CFR 493.1405 - Standard; Laboratory director qualifications.

Code of Federal Regulations, 2012 CFR

2012-10-01

... degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution... Chemistry, the American Board of Bioanalysis, or the American Board of Medical Laboratory Immunology; or (ii...) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or...

[The current clinical laboratory in the public health system and medical science: a lecture].

PubMed

Men'shikov, V V

2011-11-01

The analytic and diagnostic possibilities of current clinical laboratories are discussed. The roles of laboratory information in the formation of new research directions are characterized. The proposals on the development of economic basics of the development of laboratory medicine.

Himalayas

Atmospheric Science Data Center

2013-04-16

... million years ago as a result of the collision between the Indian and Eurasian plates, driven by tectonic processes. They continue to grow ... 14, 2000) Blocks 65-75 MISR was built and is managed by NASA's Jet Propulsion Laboratory, Pasadena, CA, for NASA's Science Mission ...

Doing that thing that scientists do: A discovery-driven module on protein purification and characterization for the undergraduate biochemistry laboratory classroom.

PubMed

Garrett, Teresa A; Osmundson, Joseph; Isaacson, Marisa; Herrera, Jennifer

2015-01-01

In traditional introductory biochemistry laboratory classes students learn techniques for protein purification and analysis by following provided, established, step-by-step procedures. Students are exposed to a variety of biochemical techniques but are often not developing procedures or collecting new, original data. In this laboratory module, students develop research skills through work on an original research project and gain confidence in their ability to design and execute an experiment while faculty can enhance their scholarly pursuits through the acquisition of original data in the classroom laboratory. Students are prepared for a 6-8 week discovery-driven project on the purification of the Escherichia coli cytidylate kinase (CMP kinase) through in class problems and other laboratory exercises on bioinformatics and protein structure analysis. After a minimal amount of guidance on how to perform the CMP kinase in vitro enzyme assay, SDS-PAGE, and the basics of protein purification, students, working in groups of three to four, develop a protein purification protocol based on the scientific literature and investigate some aspect of CMP kinase that interests them. Through this process, students learn how to implement a new but perhaps previously worked out procedure to answer their research question. In addition, they learn the importance of keeping a clear and thorough laboratory notebook and how to interpret their data and use that data to inform the next set of experiments. Following this module, students had increased confidence in their ability to do basic biochemistry techniques and reported that the "self-directed" nature of this lab increased their engagement in the project. © 2015 The International Union of Biochemistry and Molecular Biology.

Autonomy and Privacy in Clinical Laboratory Science Policy and Practice.

PubMed

Leibach, Elizabeth Kenimer

2014-01-01

Rapid advancements in diagnostic technologies coupled with growth in testing options and choices mandate the development of evidence-based testing algorithms linked to the care paths of the major chronic diseases and health challenges encountered most frequently. As care paths are evaluated, patient/consumers become partners in healthcare delivery. Clinical laboratory scientists find themselves firmly embedded in both quality improvement and clinical research with an urgent need to translate clinical laboratory information into knowledge required by practitioners and patient/consumers alike. To implement this patient-centered care approach in clinical laboratory science, practitioners must understand their roles in (1) protecting patient/consumer autonomy in the healthcare informed consent process and (2) assuring patient/consumer privacy and confidentiality while blending quality improvement study findings with protected health information. A literature review, describing the current ethical environment, supports a consultative role for clinical laboratory scientists in the clinical decision-making process and suggests guidance for policy and practice regarding the principle of autonomy and its associated operational characteristics: informed consent and privacy.

The schedule of administration of canakinumab in cryopyrin associated periodic syndrome is driven by the phenotype severity rather than the age

PubMed Central

2013-01-01

Introduction Interleukin-1 (IL-1) blockade is the treatment of choice of cryopyrin associated periodic syndromes (CAPS). Anti-IL-1 monoclonal antibody (canakinumab) was recently registered. However no clear data are available on the optimal schedule of administration of this drug. The aim of the present study was to analyse the impact of canakinumab on CAPS patients in daily clinical practice and to identify the best schedule of administration according to age and phenotype. Methods 13 CAPS patients (10 children and 3 young adults) treated with canakinumab were followed for 12 months. Clinical and laboratory parameters were collected at each visit. Health-related quality of life (HRQoL) was recorded at month 12. Complete response was defined as absence of clinical manifestations and normal examinations. Clinical and laboratory variables at last follow-up were compared with those registered at the moment of anakinra discontinuation. Results seven patients with chronic infantile neurological cutaneous articular (CINCA) syndrome, four patients with Muckle-Wells syndrome (MWS) and two patients with an overlapping MWS/CINCA phenotype were analysed. CINCA patients experienced a higher number of modifications of the treatment (increased dosage or decreased dosing interval) in respect to MWS patients. At the end of the follow-up CINCA patients displayed a higher frequency of administration with a median dose of 3.7 mg/kg (2.1 mg/kg for MWS patients). Canakinumab was withdrawn in a patient with CINCA for incomplete response and poor compliance. The effect of canakinumab on HRQoL was similar to that observed during treatment with anakinra, with the exception of an improvement of the psychosocial concepts after the introduction of canakinumab. Conclusions The use of canakinumab in daily practice is associated with persistent satisfactory control of disease activity but needs progressive dose adjustments in more severe patients. The clinical phenotype, rather than the age, represents the main variable able to determine the need of more frequent administrations of the drug at higher dosage. PMID:23442610

Thinking outside the Box: Rotor Modulation in the Treatment of Atrial Fibrillation.

PubMed

Sehra, Ruchir; Narayan, Sanjiv M; Hummel, John

2013-01-01

Ablation for atrial fibrillation (AF) is an important and exciting therapy whose results remain suboptimal. Although most clinical trials show that ablation eliminates AF more effectively than medications, it is disappointing that the continued single procedural success remains ≈50% despite the substantial advances that have taken place in imaging, catheter positioning and energy delivery. Focal impulse and rotor modulation (FIRM), on the other hand, offers the opportunity to precisely define and then ablate patient-specific sustaining mechanisms for AF, rather than trying to eliminate all possible AF triggers. For over a decade, electrophysiologists have described cases in which AF terminates after only limited ablation - usually that cannot be explained by 'random' meandering wavelets. Indeed, recent studies from several laboratories show that all forms of clinical AF are typically 'driven' by stable electrical rotors and focal sources, not by multiple meandering waves. FIRM mapping enables an operator to place a catheter at typically 1-3 predicted sites in the atria, and with <5-10 minutes of RF ablation, terminate AF and potentially render it non-inducible. Several independent laboratories have now shown that such FIRM ablation alone can terminate or substantially slow AF in >80% of patients with persistent and paroxysmal AF and increase the single procedure rate of AF elimination from 50% with PV isolation alone to >80%. Ongoing studies hint that FIRM only ablation, enabling ablation times in the range observed for typical atrial flutter, may also achieve these high success rates without subsequent trigger ablation. This review summarizes the current state-of-the-art on FIRM mapping and ablation.

Laboratory systems integration: robotics and automation.

PubMed

Felder, R A

1991-01-01

Robotic technology is going to have a profound impact on the clinical laboratory of the future. Faced with increased pressure to reduce health care spending yet increase services to patients, many laboratories are looking for alternatives to the inflexible or "fixed" automation found in many clinical analyzers. Robots are being examined by many clinical pathologists as an attractive technology which can adapt to the constant changes in laboratory testing. Already, laboratory designs are being altered to accommodate robotics and automated specimen processors. However, the use of robotics and computer intelligence in the clinical laboratory is still in its infancy. Successful examples of robotic automation exist in several laboratories. Investigators have used robots to automate endocrine testing, high performance liquid chromatography, and specimen transportation. Large commercial laboratories are investigating the use of specimen processors which combine the use of fixed automation and robotics. Robotics have also reduced the exposure of medical technologists to specimens infected with viral pathogens. The successful examples of clinical robotics applications were a result of the cooperation of clinical chemists, engineers, and medical technologists. At the University of Virginia we have designed and implemented a robotic critical care laboratory. Initial clinical experience suggests that robotic performance is reliable, however, staff acceptance and utilization requires continuing education. We are also developing a robotic cyclosporine which promises to greatly reduce the labor costs of this analysis. The future will bring lab wide automation that will fully integrate computer artificial intelligence and robotics. Specimens will be transported by mobile robots. Specimen processing, aliquotting, and scheduling will be automated.(ABSTRACT TRUNCATED AT 250 WORDS)

Combined administration of antibiotics and direct oral anticoagulants: a renewed indication for laboratory monitoring?

PubMed

Lippi, Giuseppe; Favaloro, Emmanuel J; Mattiuzzi, Camilla

2014-10-01

The recent development and marketing of novel direct oral anticoagulants (DOACs) represents a paradigm shift in the management of patients requiring long-term anticoagulation. The advantages of these compounds over traditional therapy with vitamin K antagonists include a reportedly lower risk of severe hemorrhages and the limited need for laboratory measurements. However, there are several scenarios in which testing should be applied. The potential for drug-to-drug interaction is one plausible but currently underrecognized indication for laboratory assessment of the anticoagulant effect of DOACs. In particular, substantial concern has been raised during Phase I studies regarding the potential interaction of these drugs with some antibiotics, especially those that interplay with permeability glycoprotein (P-gp) and cytochrome 3A4 (CYP3A4). A specific electronic search on clinical trials published so far confirms that clarithromycin and rifampicin significantly impair the bioavailability of dabigatran, whereas clarithromycin, erythromycin, fluconazole, and ketoconazole alter the metabolism of rivaroxaban in vivo. Because of their more recent development, no published data were found for apixaban and edoxaban, or for potential interactions of DOACs with other and widely used antibiotics. It is noteworthy, however, that an online resource based on Food and Drug Administration and social media information, reports several hemorrhagic and thrombotic events in patients simultaneously taking dabigatran and some commonly used antibiotics such as amoxicillin, cephalosporin, and metronidazole. According to these reports, the administration of antibiotics in patients undergoing therapy with DOACs would seem to require accurate evaluation as to whether dose adjustments (personalized or antibiotic class driven) of the anticoagulant drug may be advisable. This might be facilitated by direct laboratory assessments of their anticoagulant effect ex vivo. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

[What's the point of cost management in clinical laboratories?].

PubMed

Setoyama, Tomokazu; Yamauchi, Kazuyoshi; Katsuyama, Tsutomu

2006-11-01

Clinical laboratories need to know and manage the costs of laboratory tests, because they need financial data (1) to estimate costs per patient, (2) to request a budget to buy equipment, and (3) to improve their work; however, less than 40% laboratories practice cost management. In 2002, Shinshu University Hospital began to assess the costs of laboratory tests, but it was difficult to evaluate the quality of our cost management because there are few data and papers about the costs of laboratory tests in Japan. In this article, we practiced cost analysis using Shinshu University Hospital's data for 3 years (2002-2004), and studied the features of laboratory test costs and the problems of laboratory cost management. As a result, we listed 7 points to check cost management in clinical laboratories. This check list was established using only one data from our hospital. So, we suggest the benchmarking laboratory test costs between laboratories of the same type of hospitals or various laboratories.

Establishing intensivist-driven ultrasound at the PICU bedside--it's about time*.

PubMed

Su, Erik; Pustavoitau, Aliaksei; Hirshberg, Elliotte L; Nishisaki, Akira; Conlon, Thomas; Kantor, David B; Weber, Mark D; Godshall, Aaron J; Burzynski, Jeffrey H; Thompson, Ann E

2014-09-01

To discuss pediatric intensivist-driven ultrasound and the exigent need for research and practice definitions pertaining to its implementation within pediatric critical care, specifically addressing issues in ultrasound-guided vascular access and intensivist-driven echocardiography. Intensivist-driven ultrasound improves procedure safety and reduces time to diagnosis in clinical ultrasound applications, as demonstrated primarily in adult patients. Translating these applications to the PICU requires thoughtful integration of the technology into practice and would best be informed by dedicated ultrasound research in critically ill children.

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

PubMed

Wang, Sihe; Ho, Virginia

2004-08-01

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. 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. 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. 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. 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.

Neonatal Informatics: Transforming Neonatal Care Through Translational Bioinformatics

PubMed Central

Palma, Jonathan P.; Benitz, William E.; Tarczy-Hornoch, Peter; Butte, Atul J.; Longhurst, Christopher A.

2012-01-01

The future of neonatal informatics will be driven by the availability of increasingly vast amounts of clinical and genetic data. The field of translational bioinformatics is concerned with linking and learning from these data and applying new findings to clinical care to transform the data into proactive, predictive, preventive, and participatory health. As a result of advances in translational informatics, the care of neonates will become more data driven, evidence based, and personalized. PMID:22924023

A Hybrid Approach to Clinical Question Answering

DTIC Science & Technology

2014-11-01

participation in TREC, we submitted a single run using a hybrid Natural Language Processing ( NLP )-driven approach to accomplish the given task. Evaluation re...for the CDS track uses a variety of NLP - based techniques to address the clinical questions provided. We present a description of our approach, and...discuss our experimental setup, results and eval- uation in the subsequent sections. 2 Description of Our Approach Our hybrid NLP -driven method presents a

Body fluid analysis: clinical utility and applicability of published studies to guide interpretation of today's laboratory testing in serous fluids.

PubMed

Block, Darci R; Algeciras-Schimnich, Alicia

2013-01-01

Requests for testing various analytes in serous fluids (e.g., pleural, peritoneal, pericardial effusions) are submitted daily to clinical laboratories. Testing of these fluids deviates from assay manufacturers' specifications, as most laboratory assays are optimized for testing blood or urine specimens. These requests add a burden to clinical laboratories, which need to validate assay performance characteristics in these fluids to exclude matrix interferences (given the different composition of body fluids) while maintaining regulatory compliance. Body fluid testing for a number of analytes has been reported in the literature; however, understanding the clinical utility of these analytes is critical because laboratories must address the analytic and clinical validation requirements, while educating clinicians on proper test utilization. In this article, we review the published data to evaluate the clinical utility of testing for numerous analytes in body fluid specimens. We also highlight the pre-analytic and analytic variables that need to be considered when reviewing published studies in body fluid testing. Finally, we provide guidance on how published studies might (or might not) guide interpretation of test results in today's clinical laboratories.

[Management and accounting solution required in clinical laboratory department in the hospital and the balanced scorecard (BSC)].

PubMed

Takahashi, Toshiro

2006-11-01

This is to describe required accounting knowledge and the techniques for the clinical laboratory department management level people to operate their division from the viewpoint of management. Especially, the necessity and the efficacy of the BSC implementation in the clinical laboratory department are being explained.

Practicing Handoffs Early: Applying a Clinical Framework in the Anatomy Laboratory

ERIC Educational Resources Information Center

Lazarus, Michelle D.; Dos Santos, Jason A.; Haidet, Paul M.; Whitcomb, Tiffany L.

2016-01-01

The anatomy laboratory provides an ideal environment for the integration of clinical contexts as the willed-donor is often regarded as a student's "first patient." This study evaluated an innovative approach to peer teaching in the anatomy laboratory using a clinical handoff context. The authors introduced the "Situation,…

Analysis of on-line clinical laboratory manuals and practical recommendations.

PubMed

Beckwith, Bruce; Schwartz, Robert; Pantanowitz, Liron

2004-04-01

On-line clinical laboratory manuals are a valuable resource for medical professionals. To our knowledge, no recommendations currently exist for their content or design. To analyze publicly accessible on-line clinical laboratory manuals and to propose guidelines for their content. We conducted an Internet search for clinical laboratory manuals written in English with individual test listings. Four individual test listings in each manual were evaluated for 16 data elements, including sample requirements, test methodology, units of measure, reference range, and critical values. Web sites were also evaluated for supplementary information and search functions. We identified 48 on-line laboratory manuals, including 24 academic or community hospital laboratories and 24 commercial or reference laboratories. All manuals had search engines and/or test indices. No single manual contained all 16 data elements evaluated. An average of 8.9 (56%) elements were present (range, 4-14). Basic sample requirements (specimen and volume needed) were the elements most commonly present (98% of manuals). The frequency of the remaining data elements varied from 10% to 90%. On-line clinical laboratory manuals originate from both hospital and commercial laboratories. While most manuals were user-friendly and contained adequate specimen-collection information, other important elements, such as reference ranges, were frequently absent. To ensure that clinical laboratory manuals are of maximal utility, we propose the following 13 data elements be included in individual test listings: test name, synonyms, test description, test methodology, sample requirements, volume requirements, collection guidelines, transport guidelines, units of measure, reference range, critical values, test availability, and date of latest revision.

Methodology in diagnostic laboratory test research in clinical chemistry and clinical chemistry and laboratory medicine.

PubMed

Lumbreras-Lacarra, Blanca; Ramos-Rincón, José Manuel; Hernández-Aguado, Ildefonso

2004-03-01

The application of epidemiologic principles to clinical diagnosis has been less developed than in other clinical areas. Knowledge of the main flaws affecting diagnostic laboratory test research is the first step for improving its quality. We assessed the methodologic aspects of articles on laboratory tests. We included articles that estimated indexes of diagnostic accuracy (sensitivity and specificity) and were published in Clinical Chemistry or Clinical Chemistry and Laboratory Medicine in 1996, 2001, and 2002. Clinical Chemistry has paid special attention to this field of research since 1996 by publishing recommendations, checklists, and reviews. Articles were identified through electronic searches in Medline. The strategy combined the Mesh term "sensitivity and specificity" (exploded) with the text words "specificity", "false negative", and "accuracy". We examined adherence to seven methodologic criteria used in the study by Reid et al. (JAMA1995;274:645-51) of papers published in general medical journals. Three observers evaluated each article independently. Seventy-nine articles fulfilled the inclusion criteria. The percentage of studies that satisfied each criterion improved from 1996 to 2002. Substantial improvement was observed in reporting of the statistical uncertainty of indices of diagnostic accuracy, in criteria based on clinical information from the study population (spectrum composition), and in avoidance of workup bias. Analytical reproducibility was reported frequently (68%), whereas information about indeterminate results was rarely provided. The mean number of methodologic criteria satisfied showed a statistically significant increase over the 3 years in Clinical Chemistry but not in Clinical Chemistry and Laboratory Medicine. The methodologic quality of the articles on diagnostic test research published in Clinical Chemistry and Clinical Chemistry and Laboratory Medicine is comparable to the quality observed in the best general medical journals. The methodologic aspects that most need improvement are those linked to the clinical information of the populations studied. Editorial actions aimed to increase the quality of reporting of diagnostic studies could have a relevant positive effect, as shown by the improvement observed in Clinical Chemistry.

Understanding variations in secondary findings reporting practices across U.S. genome sequencing laboratories.

PubMed

Ackerman, Sara L; Koenig, Barbara A

2018-01-01

Increasingly used for clinical purposes, genome and exome sequencing can generate clinically relevant information that is not directly related to the reason for testing (incidental or secondary findings). Debates about the ethical implications of secondary findings were sparked by the American College of Medical Genetics (ACMG) 2013 policy statement, which recommended that laboratories report pathogenic alterations in 56 genes. Although wide variation in laboratories' secondary findings policies has been reported, little is known about its causes. We interviewed 18 laboratory directors and genetic counselors at 10 U.S. laboratories to investigate the motivations and interests shaping secondary findings reporting policies for clinical exome sequencing. Analysis of interview transcripts and laboratory documents was informed by sociological theories of standardization. Laboratories varied widely in terms of the types of secondary findings reported, consent-form language, and choices offered to patients. In explaining their adaptation of the ACMG report, our participants weighed genetic information's clinical, moral, professional, and commercial value in an attempt to maximize benefits for patients and families, minimize the costs of sequencing and analysis, adhere to professional norms, attract customers, and contend with the uncertain clinical implications of much of the genetic information generated. Nearly all laboratories in our study voluntarily adopted ACMG's recommendations, but their actual practices varied considerably and were informed by laboratory-specific judgments about clinical utility and patient benefit. Our findings offer a compelling example of standardization as a complex process that rarely leads simply to uniformity of practice. As laboratories take on a more prominent role in decisions about the return of genetic information, strategies are needed to inform patients, families, and clinicians about the differences between laboratories' practices and ensure that the consent process prompts a discussion of the value of additional genetic information for patients and their families.

Quality and future of clinical laboratories: the Vico's whole cyclical theory of the recurring cycles.

PubMed

Plebani, Mario

2018-05-24

In the last few decades, laboratory medicine has undergone monumental changes, and laboratory technology, which has made enormous advances, now has new clinical applications thanks to the identification of a growing number of biomarkers and risk factors conducive to the promotion of predictive and preventive interventions that have enhanced the role of laboratory medicine in health care delivering. However, the paradigm shift in the past 50 years has led to a gap between laboratory and clinic, with an increased risk of inappropriateness in test request and interpretation, as well as the consolidation of analytical work in focused factories and megastructurers oriented only toward achieving greater volumes, decreasing cost per test and generating a vision of laboratory services as simple commodities. A careful historical revision of the changing models for delivering laboratory services in the United States leads to the prediction that there are several reasons for counteracting the vision of clinical laboratory as a commodity, and restoring the true nature of laboratory services as an integral part of the diagnosis and therapy process. The present study, which reports on internal and external drivers for change, proposes an integrated vision of quality in laboratory medicine.

Towards more effective robotic gait training for stroke rehabilitation: a review

PubMed Central

2012-01-01

Background Stroke is the most common cause of disability in the developed world and can severely degrade walking function. Robot-driven gait therapy can provide assistance to patients during training and offers a number of advantages over other forms of therapy. These potential benefits do not, however, seem to have been fully realised as of yet in clinical practice. Objectives This review determines ways in which robot-driven gait technology could be improved in order to achieve better outcomes in gait rehabilitation. Methods The literature on gait impairments caused by stroke is reviewed, followed by research detailing the different pathways to recovery. The outcomes of clinical trials investigating robot-driven gait therapy are then examined. Finally, an analysis of the literature focused on the technical features of the robot-based devices is presented. This review thus combines both clinical and technical aspects in order to determine the routes by which robot-driven gait therapy could be further developed. Conclusions Active subject participation in robot-driven gait therapy is vital to many of the potential recovery pathways and is therefore an important feature of gait training. Higher levels of subject participation and challenge could be promoted through designs with a high emphasis on robotic transparency and sufficient degrees of freedom to allow other aspects of gait such as balance to be incorporated. PMID:22953989

The Role of the Clinical Laboratory in the Future of Health Care: Lean Microbiology

PubMed Central

Samuel, Linoj

2014-01-01

This commentary will introduce lean concepts into the clinical microbiology laboratory. The practice of lean in the clinical microbiology laboratory can remove waste, increase efficiency, and reduce costs. Lean, Six Sigma, and other such management initiatives are useful tools and can provide dividends but must be accompanied by organizational leadership commitment to sustaining the lean culture in the laboratory setting and providing resources and time to work through the process. PMID:24574289

Mentos and Scientific Method: A Sweet Combination

ERIC Educational Resources Information Center

Eichler, Jack F.; Patrick, Heather; Harmon, Brenda; Coonce, Janet

2007-01-01

Several active-learning techniques and inquiry-driven laboratory exercises were incorporated in labs to determine the effects of these methodologies on the fundamental skills of the students. The practice has been found extremely useful for developing the learning abilities of the students.

An e-health driven laboratory information system to support HIV treatment in Peru: E-quity for laboratory personnel, health providers and people living with HIV.

PubMed

García, Patricia J; Vargas, Javier H; Caballero N, Patricia; Calle V, Javier; Bayer, Angela M

2009-12-10

Peru has a concentrated HIV epidemic with an estimated 76,000 people living with HIV (PLHIV). Access to highly active antiretroviral therapy (HAART) expanded between 2004-2006 and the Peruvian National Institute of Health was named by the Ministry of Health as the institution responsible for carrying out testing to monitor the effectiveness of HAART. However, a national public health laboratory information system did not exist. We describe the design and implementation of an e-health driven, web-based laboratory information system--NETLAB--to communicate laboratory results for monitoring HAART to laboratory personnel, health providers and PLHIV. We carried out a needs assessment of the existing public health laboratory system, which included the generation and subsequent review of flowcharts of laboratory testing processes to generate better, more efficient streamlined processes, improving them and eliminating duplications. Next, we designed NETLAB as a modular system, integrating key security functions. The system was implemented and evaluated. The three main components of the NETLAB system, registration, reporting and education, began operating in early 2007. The number of PLHIV with recorded CD4 counts and viral loads increased by 1.5 times, to reach 18,907. Publication of test results with NETLAB took an average of 1 day, compared to a pre-NETLAB average of 60 days. NETLAB reached 2,037 users, including 944 PLHIV and 1,093 health providers, during its first year and a half. The percentage of overall PLHIV and health providers who were aware of NETLAB and had a NETLAB password has also increased substantially. NETLAB is an effective laboratory management tool since it is directly integrated into the national laboratory system and streamlined existing processes at the local, regional and national levels. The system also represents the best possible source of timely laboratory information for health providers and PLHIV, allowing patients to access their own results and other helpful information about their health, extending the scope of HIV treatment beyond the health facility and providing a model for other countries to follow. The NETLAB system now includes 100 diseases of public health importance for which the Peruvian National Institute of Health and the network of public health laboratories provide testing and results.

Individualized Quality Control Plan (IQCP): Is It Value-Added for Clinical Microbiology?

PubMed Central

Miller, Melissa B.; Hindler, Janet

2015-01-01

The Center for Medicaid and Medicare Services (CMS) recently published their Individualized Quality Control Plan (IQCP [https://www.cms.gov/regulations-and-guidance/legislation/CLIA/Individualized_Quality_Control_Plan_IQCP.html]), which will be the only option for quality control (QC) starting in January 2016 if laboratories choose not to perform Clinical Laboratory Improvement Act (CLIA) [U.S. Statutes at Large 81(1967):533] default QC. Laboratories will no longer be able to use “equivalent QC” (EQC) or the Clinical and Laboratory Standards Institute (CLSI) standards alone for quality control of their microbiology systems. The implementation of IQCP in clinical microbiology laboratories will most certainly be an added burden, the benefits of which are currently unknown. PMID:26447112

78 FR 44954 - Clinical Laboratory Improvement Advisory Committee (CLIAC)

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-25

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Clinical... and Human Services; the Assistant Secretary for Health; the Director, Centers for Disease Control and... laboratory quality and laboratory [[Page 44955

Implementation of a pharmacist-driven immunization program designed to improve overall vaccination rates in indigent and uninsured patients.

PubMed

Stilwell, Allison M; Pavero, Chris; Buxton, Jennifer; Herrington, Glenn

To demonstrate the results of a pharmacist-driven immunization program designed to increase overall vaccination rates among the low-income, uninsured patients in a free clinic. Cape Fear Clinic, a free clinic located in Wilmington, North Carolina. Cape Fear Clinic provides medical, pharmacy, mental health, and dental services to adults in 4 eastern North Carolina counties who are uninsured and have incomes of no more than 200% of Federal Poverty Guidelines. A pharmacist-driven immunization program consisting of a comprehensive chart review of every active clinic patient in order to improve the vaccination status of the clinic's patients at no cost to the patient. Student pharmacists completed a comprehensive chart review of every active clinic patient to identify patients eligible for immunizations according to the Advisory Committee on Immunization Practices guidelines. More than 500 patients eligible for immunizations were notified of their immunization status and educated about indicated vaccinations. Patients willing to receive indicated vaccinations would present to the pharmacy and a pharmacist or student pharmacist administered the necessary doses. The vaccine initiative was introduced January 1, 2015 and has since delivered 1878 doses of vaccines as of June 30, 2016. The immunization program implemented by pharmacists and student pharmacists at Cape Fear Clinic has been successful in increasing awareness of vaccine preventable diseases as well as increasing rates of vaccination among eligible clinic patients. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Does bacteriology laboratory automation reduce time to results and increase quality management?

PubMed

Dauwalder, O; Landrieve, L; Laurent, F; de Montclos, M; Vandenesch, F; Lina, G

2016-03-01

Due to reductions in financial and human resources, many microbiological laboratories have merged to build very large clinical microbiology laboratories, which allow the use of fully automated laboratory instruments. For clinical chemistry and haematology, automation has reduced the time to results and improved the management of laboratory quality. The aim of this review was to examine whether fully automated laboratory instruments for microbiology can reduce time to results and impact quality management. This study focused on solutions that are currently available, including the BD Kiestra™ Work Cell Automation and Total Lab Automation and the Copan WASPLab(®). Copyright © 2015 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Injection of externally produced kinetic electrons into a self-guided laser wakefield accelerator

NASA Astrophysics Data System (ADS)

Pollock, Bradley; Ralph, Joseph; Albert, Felicie; Shaw, Jessica; Clayton, Christopher; Marsh, Ken; Joshi, Chan; Mori, Warren; Kesler, Leigh; Mills, Sarah; Severson, Brian; Rigby, Alexandra; Glenzer, Siegfried

2012-10-01

A two-stage laser wakefield accelerator is being developed at the Lawrence Livermore National Laboratory using the Callisto laser system. The first stage is a high density (˜10^19 cm-3), 5 mm He gas jet plasma which is driven by 30 TW of 800 nm laser light focused to an a0˜ 2. The <100 MeV electrons produced in this stage are deflected by a 0.5 T dipole magnet onto the axis of the second stage, which is a low density (˜10^18 cm-3), 15 mm He gas cell driven by 200 TW of 800 nm light also focused to an a0˜ 2; no additional electrons are trapped in this stage. Electrons injected into the second stage can then be further accelerated to higher energy without increasing the energy spread. Measurements of the transmitted laser profile and spectrum from the second stage indicate that the laser pulse is self-guided throughout the gas cell and that a strong wake is driven. These results compare well with particle-in-cell (PIC) simulations performed with the code OSIRIS. This work was performed under the auspices of the United States Department of Energy by the Lawrence Livermore National Laboratory under contract No. DE-AC52-07NA-27344.

Principles and implementations of electrolysis systems for water splitting

DOE PAGES

Xiang, Chengxiang; Papadantonakis, Kimberly M.; Lewis, Nathan S.

2016-02-12

Efforts to develop renewable sources of carbon-neutral fuels have brought a renewed focus to research and development of sunlight-driven water-splitting systems. Electrolysis of water to produce H 2 and O 2 gases is the foundation of such systems, is conceptually and practically simple, and has been practiced both in the laboratory and industrially for many decades. In this Focus article, the fundamentals of water splitting and practices which distinguish commercial water-electrolysis systems from simple laboratory-scale demonstrations are described.

Integration of next-generation sequencing in clinical diagnostic molecular pathology laboratories for analysis of solid tumours; an expert opinion on behalf of IQN Path ASBL.

PubMed

Deans, Zandra C; Costa, Jose Luis; Cree, Ian; Dequeker, Els; Edsjö, Anders; Henderson, Shirley; Hummel, Michael; Ligtenberg, Marjolijn Jl; Loddo, Marco; Machado, Jose Carlos; Marchetti, Antonio; Marquis, Katherine; Mason, Joanne; Normanno, Nicola; Rouleau, Etienne; Schuuring, Ed; Snelson, Keeda-Marie; Thunnissen, Erik; Tops, Bastiaan; Williams, Gareth; van Krieken, Han; Hall, Jacqueline A

2017-01-01

The clinical demand for mutation detection within multiple genes from a single tumour sample requires molecular diagnostic laboratories to develop rapid, high-throughput, highly sensitive, accurate and parallel testing within tight budget constraints. To meet this demand, many laboratories employ next-generation sequencing (NGS) based on small amplicons. Building on existing publications and general guidance for the clinical use of NGS and learnings from germline testing, the following guidelines establish consensus standards for somatic diagnostic testing, specifically for identifying and reporting mutations in solid tumours. These guidelines cover the testing strategy, implementation of testing within clinical service, sample requirements, data analysis and reporting of results. In conjunction with appropriate staff training and international standards for laboratory testing, these consensus standards for the use of NGS in molecular pathology of solid tumours will assist laboratories in implementing NGS in clinical services.

Laboratory approach for diagnosis of toluene-based inhalant abuse in a clinical setting

PubMed Central

Jain, Raka; Verma, Arpita

2016-01-01

The steady increase of inhalant abuse is a great challenge for analytical toxicologists. This review describes an overview of inhalant abuse including the extent of the problem, types of products abused, modes of administration, pharmacology and effects of inhalants, the role of laboratory, interpretation of laboratory results and clinical considerations. Regular laboratory screening for inhalant abuse as well as other substance abuse and health risk behaviors must be a part of standard clinical care. PMID:26957863

Building bridges between clinical and forensic toxicology laboratories.

PubMed

Martin, Bernardino Barcelo; Gomila, Isabel; Noce, Valeria

2018-05-09

Clinical and forensic toxicology can be defined as the two disciplines involved the detection, identification and measurement of xenobiotics in biological and non-biological specimens to help in the diagnosis, treatment, prognosis, prevention of poisonings and to disclose causes and contributory causes of fatal intoxications, respectively. This article explores the close connections between clinical and forensic toxicology in overlapping areas of interest. An update has been carried out of the following seven areas of interest in analytical toxicology: doping control, sudden cardiac death (SCD), brain death, sudden infant death syndrome (SIDS) and Munchausen syndrome by proxy (MSBP), prenatal exposure to drugs and fetal alcohol syndrome (FAS), drug-facilitated crimes (DFC) and intoxications by new psychoactive substances (NPS). While issues such as SCD, SIDS or doping control are investigated mainly in forensic laboratories, other as prenatal exposure to drugs or FAS are mainly treated in clinical laboratories. On the other hand, areas such MSBP, DFC or the intoxications by NPS are of interest in both laboratories. Some of these topics are initially treated in hospital emergency departments, involving clinical laboratories and sometimes lately derived to forensic laboratories. Conversely, cases with initial medical-legal implications and fatalities are directly handled by forensic toxicology, but may trigger further studies in the clinical setting. Many areas of common interest between clinical and forensic laboratories are building bridges between them. The increasing relationships are improving the growth, the reliability and the robustness of both kind of laboratories. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Evaluation of the enterovirus laboratory surveillance system in Denmark, 2010 to 2013.

PubMed

Condell, Orla; Midgley, Sofie; Christiansen, Claus Bohn; Chen, Ming; Chen Nielsen, Xiaohui; Ellermann-Eriksen, Svend; Mølvadgaard, Mette; Schønning, Kristian; Vermedal Hoegh, Silje; Andersen, Peter Henrik; Voldstedlund, Marianne; Fischer, Thea Kølsen

2016-05-05

The primary aim of the Danish enterovirus (EV) surveillance system is to document absence of poliovirus infection. The conflict in Syria has left many children unvaccinated and movement from areas with polio cases to Europe calls for increased awareness to detect and respond to virus-transmission in a timely manner. We evaluate the national EV laboratory surveillance, to generate recommendations for system strengthening. The system was analysed for completeness of viral typing analysis and clinical information and timeliness of specimen collection, laboratory results and reporting of clinical information. Of 23,720 specimens screened, 2,202 (9.3%) were EV-positive. Submission of cerebrospinal fluid and faecal specimens from primary diagnostic laboratories was 79.5% complete (845/1,063), and varied by laboratory and patient age. EV genotypes were determined in 68.5% (979/1,430) of laboratory-confirmed cases, clinical information was available for 63.1% (903/1,430). Primary diagnostic results were available after a median of 1.4 days, typing results after 17 days, detailed clinical information after 33 days. The large number of samples typed demonstrated continued monitoring of EV-circulation in Denmark. The system could be strengthened by increasing the collection of supplementary faecal specimens, improving communication with primary diagnostic laboratories, adapting the laboratory typing methodology and collecting clinical information with electronic forms.

First reported case of intrachromosomal cryptic inv dup del Xp in a boy with developmental retardation.

PubMed

Dupont, Celine; Lebbar, Aziza; Teinturier, Cecile; Baverel, Françoise; Viot, Geraldine; Le Tessier, Dominique; Le Bozec, Jerome; Cuisset, Laurence; Dupont, Jean-Michel

2007-06-01

We report here on a 6-year-old boy referred to the laboratory for karyotyping and SHOX microdeletion testing. The most significant clinical findings in this boy were small stature, Madelung deformity, facial dysmorphism, mild mental retardation and behavioral problems. R-, G- and RTBG-banding chromosome analysis showed a normal male karyotype. Fine molecular characterization, by FISH, of terminal Xp microdeletion revealed an associated partial duplication. Further refinement of the molecular analysis indicated an inverted duplication of the Xp22.31-Xp22.32 (13.7 Mb) region including the STS, VCX-A and KAL1 genes, associated with a terminal Xp deletion Xp22.33-Xpter (3.6 Mb) encompassing the SHOX and ARSE genes. Such rearrangements have been characterized for other chromosomal pairs, but this is the first reported male patient involving the short arm of the X chromosome. Molecular analysis of the maternal and patient's microsatellite markers showed interchromatid mispairing leading to non-allelic homologous recombination to be the most likely mechanism underlying this rearrangement. This case highlights the importance of clinically driven FISH investigations in order to uncover cryptic micro-rearrangements. Copyright (c) 2007 Wiley-Liss, Inc.

Scan-layered reconstructions: A pilot study of a nondestructive dental histoanatomical analysis method and digital workflow to create restorations driven by natural dentin and enamel morphology.

PubMed

Malta Barbosa, João; Tovar, Nick; A Tuesta, Pablo; Hirata, Ronaldo; Guimarães, Nuno; Romanini, José C; Moghadam, Marjan; Coelho, Paulo G; Jahangiri, Leila

2017-07-08

This work aims to present a pilot study of a non-destructive dental histo-anatomical analysis technique as well as to push the boundaries of the presently available restorative workflows for the fabrication of highly customized ceramic restorations. An extracted human maxillary central incisor was subject to a micro computed tomography scan and the acquired data was transferred into a workstation, reconstructed, segmented, evaluated and later imported into a Computer-Aided Design/Computer-Aided Manufacturing software for the fabrication of a ceramic resin-bonded prosthesis. The obtained prosthesis presented an encouraging optical behavior and was used clinically as final restoration. The digitally layered restorative replication of natural tooth morphology presents today as a clear possibility. New clinical and laboratory-fabricated, biologically inspired digital restorative protocols are to be expected in the near future. The digitally layered restorative replication of natural tooth morphology presents today as a clear possibility. This pilot study may represent a stimulus for future research and applications of digital imaging as well as digital restorative workflows in service of esthetic dentistry. © 2017 Wiley Periodicals, Inc.

CAP/ACMG proficiency testing for biochemical genetics laboratories: a summary of performance.

PubMed

Oglesbee, Devin; Cowan, Tina M; Pasquali, Marzia; Wood, Timothy C; Weck, Karen E; Long, Thomas; Palomaki, Glenn E

2018-01-01

PurposeTesting for inborn errors of metabolism is performed by clinical laboratories worldwide, each utilizing laboratory-developed procedures. We sought to summarize performance in the College of American Pathologists' (CAP) proficiency testing (PT) program and identify opportunities for improving laboratory quality. When evaluating PT data, we focused on a subset of laboratories that have participated in at least one survey since 2010.MethodsAn analysis of laboratory performance (2004 to 2014) on the Biochemical Genetics PT Surveys, a program administered by CAP and the American College of Medical Genetics and Genomics. Analytical and interpretive performance was evaluated for four tests: amino acids, organic acids, acylcarnitines, and mucopolysaccharides.ResultsSince 2010, 150 laboratories have participated in at least one of four PT surveys. Analytic sensitivities ranged from 88.2 to 93.4%, while clinical sensitivities ranged from 82.4 to 91.0%. Performance was higher for US participants and for more recent challenges. Performance was lower for challenges with subtle findings or complex analytical patterns.ConclusionUS clinical biochemical genetics laboratory proficiency is satisfactory, with a minority of laboratories accounting for the majority of errors. Our findings underscore the complex nature of clinical biochemical genetics testing and highlight the necessity of continuous quality management.

Data-driven asthma endotypes defined from blood biomarker and gene expression data

EPA Science Inventory

The diagnosis and treatment of childhood asthma is complicated by its mechanistically distinct subtypes (endotypes) driven by genetic susceptibility and modulating environmental factors. Clinical biomarkers and blood gene expression were collected from a stratified, cross-section...

Laboratory Diagnosis and Characterization of Fungal Disease in Patients with Cystic Fibrosis (CF): A Survey of Current UK Practice in a Cohort of Clinical Microbiology Laboratories.

PubMed

Boyle, Maeve; Moore, John E; Whitehouse, Joanna L; Bilton, Diana; Downey, Damian G

2018-03-02

There is much uncertainty as to how fungal disease is diagnosed and characterized in patients with cystic fibrosis (CF). A 19-question anonymous electronic questionnaire was developed and distributed to ascertain current practice in clinical microbiology laboratories providing a fungal laboratory service to CF centres in the UK. Analyses of responses identified the following: (1) current UK laboratory practice, in general, follows the current guidelines, but the scope and diversity of what is currently being delivered by laboratories far exceeds what is detailed in the guidelines; (2) there is a lack of standardization of fungal tests amongst laboratories, outside of the current guidelines; (3) both the UK CF Trust Laboratory Standards for Processing Microbiological Samples from People with Cystic Fibrosis and the US Cumulative Techniques and Procedures in Clinical Microbiology (Cumitech) Guidelines 43 Cystic Fibrosis Microbiology need to be updated to reflect both new methodological innovations, as well as better knowledge of fungal disease pathophysiology in CF; (4) there is a need for clinical medicine to decide upon a stratification strategy for the provision of new fungal assays that will add value to the physician in the optimal management of CF patients; (5) there is also a need to rationale what assays should be performed at local laboratory level and those which are best served at National Mycology Reference Laboratory level; and (6) further research is required in developing laboratory assays, which will help ascertain the clinical importance of 'old' fungal pathogens, as well as 'emerging' fungal pathogens.

Studies of Radiation-Driven and Buoyancy-Driven Fluid Flows and Transport

NASA Technical Reports Server (NTRS)

Ronney, Paul D.; Fortmeyer, Justin M.

1994-01-01

It is well known that radiative heat transport influences many types of buoyant flows due to its effect on the temperature and thus density field in the fluid medium. It is of interest to study gaseous flows driven solely by radiation in the absence of buoyancy, particularly because of its application to astrophysical flows that are well known from astronomical observations and numerical simulation. However, no laboratory-scale experiments of this phenomenon have ever been conducted. To study the possibility of obtaining such flows in the laboratory, an apparatus was built to produce large temperature differences (Delta T) up to 300 K in a gas confined between flat parallel plates. SF6 was used as the radiatively-active gas because its Planck absorption length is much shorter than that of any other common non-reactive gas. The NASA-Lewis 2.2 second drop tower was used to obtain reduced gravity in order to suppress buoyancy effects. To image the resulting flows, a laser shearing interferometer was employed. Initial results indicate the presence of flow that does not appear to be attributable to the residual flow resulting from buoyancy influences before the drop. For Delta T greater than 70 K, slight deformations in the interferometer fringes seen at lower Delta T became large unsteady swirls. Such behavior did not occur for radiatively-inactive gases, suggesting that a flow driven solely by radiation was obtained in SF6 and to a lesser extent in CO2 This was more pronounced at higher pressures and plate spacings, consistent with our scaling predictions.

Studies of Radiation-Driven and Buoyancy-Driven Fluid Flows and Transport

NASA Technical Reports Server (NTRS)

Ronney, Paul D.; Fortmeyer, Justin M.

1996-01-01

It is well known that radiative heat transport influences many types of buoyant flows due to its effect on the temperature and thus density field in the fluid medium. It is of interest to study gaseous flows driven solely by radiation in the absence of buoyancy, particularly because of its application to astrophysical flows that are well known from astronomical observations and numerical simulation. However, no laboratory-scale experiments of this phenomenon have ever been conducted. To study the possibility of obtaining such flows in the laboratory, an apparatus was built to produce large temperature differences (Delta (T)) up to 300 K in a gas confined between flat parallel plates. SF6 was used as the radiatively-active gas because its Planck absorption length is much shorter than that of any other common non-reactive gas. The NASA-Lewis 2.2 second drop tower was used to obtain reduced gravity in order to suppress buoyancy effects. To image the resulting flows, a laser shearing interferometer was employed. Initial results indicate the presence of flow that does not appear to be attributable to the residual flow resulting from buoyancy influences before the drop. For Delta(T) greater than 70 K, slight deformations in the interferometer fringes seen at lower Delta(T) became large unsteady swirls. Such behavior did not occur for radiatively-inactive gases, suggesting that a flow driven solely by radiation was obtained in SF6 and to a lesser extent in CO2. This was more pronounced at higher pressures and plate spacings, consistent with our scaling predictions.

Miniaturization and globalization of clinical laboratory activities.

PubMed

Melo, Murilo R; Clark, Samantha; Barrio, Daniel

2011-04-01

Clinical laboratories provide an invaluable service to millions of people around the world in the form of quality diagnostic care. Within the clinical laboratory industry the impetus for change has come from technological development (miniaturization, nanotechnology, and their collective effect on point-of-care testing; POCT) and the increasingly global nature of laboratory services. Potential technological gains in POCT include: the development of bio-sensors, microarrays, genetics and proteomics testing, and enhanced web connectivity. In globalization, prospective opportunities lie in: medical tourism, the migration of healthcare workers, cross-border delivery of testing, and the establishment of accredited laboratories in previously unexplored markets. Accompanying these impressive opportunities are equally imposing challenges. Difficulty transitioning from research to clinical use, poor infrastructure in developing countries, cultural differences and national barriers to global trade are only a few examples. Dealing with the issues presented by globalization and the impact of developing technology on POCT, and on the clinical laboratory services industry in general, will be a daunting task. Despite such concerns, with appropriate countermeasures it will be possible to address the challenges posed. Future laboratory success will be largely dependent on one's ability to adapt in this perpetually shifting landscape.

42 CFR 414.509 - Reconsideration of basis for and amount of payment for a new clinical diagnostic laboratory test.

Code of Federal Regulations, 2011 CFR

2011-10-01

...) or § 414.509(a)(3) that the basis for payment for a new test will be gapfilling, CMS posts interim... for a new clinical diagnostic laboratory test. 414.509 Section 414.509 Public Health CENTERS FOR... FOR PART B MEDICAL AND OTHER HEALTH SERVICES Payment for New Clinical Diagnostic Laboratory Tests...

Staff and students' perceptions and experiences of teaching and assessment in Clinical Skills Laboratories: interview findings from a multiple case study.

PubMed

Houghton, Catherine E; Casey, Dympna; Shaw, David; Murphy, Kathy

2012-08-01

The Clinical Skills Laboratory has become an essential structure in nurse education and several benefits of its use have been identified. However, the literature identifies the need to examine the transferability of skills learned there into the reality of practice. This research explored the role of the Clinical Skills Laboratory in preparing nursing students for the real world of practice. This paper focuses specifically on the perceptions of the teaching and assessment strategies employed there. Qualitative multiple case study design. Five case study sites. Interviewees (n=58) included academic staff, clinical staff and nursing students. Semi-structured interviews. The Clinical Skills Laboratory can provide a pathway to practice and its authenticity is significant. Teaching strategies need to incorporate communication as well as psychomotor skills. Including audio-visual recording into assessment strategies is beneficial. Effective relationships between education institutions and clinical settings are needed to enhance the transferability of the skills learned. The Clinical Skills Laboratory should provide an authentic learning environment, with the appropriate use of teaching strategies. It is crucial that effective links between educators and clinical staff are established and maintained. Copyright © 2011 Elsevier Ltd. All rights reserved.

Individualized Quality Control Plan (IQCP): Is It Value-Added for Clinical Microbiology?

PubMed

Sharp, Susan E; Miller, Melissa B; Hindler, Janet

2015-12-01

The Center for Medicaid and Medicare Services (CMS) recently published their Individualized Quality Control Plan (IQCP [https://www.cms.gov/regulations-and-guidance/legislation/CLIA/Individualized_Quality_Control_Plan_IQCP.html]), which will be the only option for quality control (QC) starting in January 2016 if laboratories choose not to perform Clinical Laboratory Improvement Act (CLIA) [U.S. Statutes at Large 81(1967):533] default QC. Laboratories will no longer be able to use "equivalent QC" (EQC) or the Clinical and Laboratory Standards Institute (CLSI) standards alone for quality control of their microbiology systems. The implementation of IQCP in clinical microbiology laboratories will most certainly be an added burden, the benefits of which are currently unknown. Copyright © 2015, American Society for Microbiology. All Rights Reserved.

The genetics and biology of KRAS in lung cancer

PubMed Central

Westcott, Peter M. K.; To, Minh D.

2013-01-01

Mutational activation of KRAS is a common oncogenic event in lung cancer and other epithelial cancer types. Efforts to develop therapies that counteract the oncogenic effects of mutant KRAS have been largely unsuccessful, and cancers driven by mutant KRAS remain among the most refractory to available treatments. Studies undertaken over the past decades have produced a wealth of information regarding the clinical relevance of KRAS mutations in lung cancer. Mutant Kras-driven mouse models of cancer, together with cellular and molecular studies, have provided a deeper appreciation for the complex functions of KRAS in tumorigenesis. However, a much more thorough understanding of these complexities is needed before clinically effective therapies targeting mutant KRAS-driven cancers can be achieved. PMID:22776234

[CAP quality management system in clinical laboratory and its issue].

PubMed

Tazawa, Hiromitsu

2004-03-01

The CAP (College of American Pathologists) was established in 1962 and, at present, CAP-accredited laboratories include about 6000 institutions all over the world, mainly in the U.S. The essential purpose of CAP accreditation is high quality reservation and improvement of clinical laboratory services for patient care, and is based on seven points, listed below. (1) Establishment of a laboratory management program and laboratory techniques to assure accuracy and improve overall quality of laboratory services. (2) Maintenance and improvement of accuracy objectively by centering on a CAP survey. (3) Thoroughness in safety and health administration. (4) Reservation of the performance of laboratory services by personnel and proficiency management. (5) Provision of appropriate information to physicians, and contribution to improved quality of patient care by close communication with physicians (improvement in patient care). (6) Reduction of running costs and personnel costs based on evidence by employing the above-mentioned criteria. (7) Reduction of laboratory error. In the future, accreditation and/or certification by organizations such as CAP, ISO, etc., may become a requirement for providing any clinical laboratory services in Japan. Taking the essence of the CAP and the characteristics of the new international standard, ISO151589, into consideration, it is important to choose the best suited accreditation and/or certification depending of the purpose of clinical laboratory.

[Current biosafety in clinical laboratories in Japan: report of questionnaires' data obtained from clinical laboratory personnel in Japan].

PubMed

Goto, Mieko; Yamashita, Tomonari; Misawa, Shigeki; Komori, Toshiaki; Okuzumi, Katsuko; Takahashi, Takashi

2007-01-01

To determine the status of biosafety in clinical laboratories in Japan, we conducted a survey using questionnaires on the biosafety of laboratory personnel in 2004. We obtained data from 431 hospitals (response: 59.5%). Respondents were 301 institutions (70%) having biological safety cabinets (BSCs). BSCs were held in 78% of microbiological laboratories, 7.9% of genetic laboratories, 2.7% of histopathological laboratories, and 1% or less at other laboratories. A clean bench in examination rooms for acid-fast bacilli was applied at 20 hospitals. We found 28 cases of possible laboratory-associated tuberculosis infection, 25 of which were associated with lack of BSC. Other risk factors were immature skills and insufficiently skilled eguipment operation. The frequency of rupture accidents during specimen centrifugation was 67% in dealing with blood and 9.7% in collecting acid-fast bacilli. Half or more accidents were related to inadequate sample tube materials. Technologists were shown to be working on blood collection in many hospitals (75%), and 1,534 events of self-inflicted needle puncture developed in the last 5 years. These results suggest that biosafety systems are woefully lacking or inadequate in clinical laboratories in Japan and must be established at the earliest possible opportunity.

National Survey of Adult and Pediatric Reference Intervals in Clinical Laboratories across Canada: A Report of the CSCC Working Group on Reference Interval Harmonization.

PubMed

Adeli, Khosrow; Higgins, Victoria; Seccombe, David; Collier, Christine P; Balion, Cynthia M; Cembrowski, George; Venner, Allison A; Shaw, Julie

2017-11-01

Reference intervals are widely used decision-making tools in laboratory medicine, serving as health-associated standards to interpret laboratory test results. Numerous studies have shown wide variation in reference intervals, even between laboratories using assays from the same manufacturer. Lack of consistency in either sample measurement or reference intervals across laboratories challenges the expectation of standardized patient care regardless of testing location. Here, we present data from a national survey conducted by the Canadian Society of Clinical Chemists (CSCC) Reference Interval Harmonization (hRI) Working Group that examines variation in laboratory reference sample measurements, as well as pediatric and adult reference intervals currently used in clinical practice across Canada. Data on reference intervals currently used by 37 laboratories were collected through a national survey to examine the variation in reference intervals for seven common laboratory tests. Additionally, 40 clinical laboratories participated in a baseline assessment by measuring six analytes in a reference sample. Of the seven analytes examined, alanine aminotransferase (ALT), alkaline phosphatase (ALP), and creatinine reference intervals were most variable. As expected, reference interval variation was more substantial in the pediatric population and varied between laboratories using the same instrumentation. Reference sample results differed between laboratories, particularly for ALT and free thyroxine (FT4). Reference interval variation was greater than test result variation for the majority of analytes. It is evident that there is a critical lack of harmonization in laboratory reference intervals, particularly for the pediatric population. Furthermore, the observed variation in reference intervals across instruments cannot be explained by the bias between the results obtained on instruments by different manufacturers. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Current status of verification practices in clinical biochemistry in Spain.

PubMed

Gómez-Rioja, Rubén; Alvarez, Virtudes; Ventura, Montserrat; Alsina, M Jesús; Barba, Núria; Cortés, Mariano; Llopis, María Antonia; Martínez, Cecilia; Ibarz, Mercè

2013-09-01

Verification uses logical algorithms to detect potential errors before laboratory results are released to the clinician. Even though verification is one of the main processes in all laboratories, there is a lack of standardization mainly in the algorithms used and the criteria and verification limits applied. A survey in clinical laboratories in Spain was conducted in order to assess the verification process, particularly the use of autoverification. Questionnaires were sent to the laboratories involved in the External Quality Assurance Program organized by the Spanish Society of Clinical Biochemistry and Molecular Pathology. Seven common biochemical parameters were included (glucose, cholesterol, triglycerides, creatinine, potassium, calcium, and alanine aminotransferase). Completed questionnaires were received from 85 laboratories. Nearly all the laboratories reported using the following seven verification criteria: internal quality control, instrument warnings, sample deterioration, reference limits, clinical data, concordance between parameters, and verification of results. The use of all verification criteria varied according to the type of verification (automatic, technical, or medical). Verification limits for these parameters are similar to biological reference ranges. Delta Check was used in 24% of laboratories. Most laboratories (64%) reported using autoverification systems. Autoverification use was related to laboratory size, ownership, and type of laboratory information system, but amount of use (percentage of test autoverified) was not related to laboratory size. A total of 36% of Spanish laboratories do not use autoverification, despite the general implementation of laboratory information systems, most of them, with autoverification ability. Criteria and rules for seven routine biochemical tests were obtained.

Molecular pathology curriculum for medical laboratory scientists: A report of the association for molecular pathology training and education committee.

PubMed

Taylor, Sara; Bennett, Katie M; Deignan, Joshua L; Hendrix, Ericka C; Orton, Susan M; Verma, Shalini; Schutzbank, Ted E

2014-05-01

Molecular diagnostics is a rapidly growing specialty in the clinical laboratory assessment of pathology. Educational programs in medical laboratory science and specialized programs in molecular diagnostics must address the training of clinical scientists in molecular diagnostics, but the educational curriculum for this field is not well defined. Moreover, our understanding of underlying genetic contributions to specific diseases and the technologies used in molecular diagnostics laboratories change rapidly, challenging providers of training programs in molecular diagnostics to keep their curriculum current and relevant. In this article, we provide curriculum recommendations to molecular diagnostics training providers at both the baccalaureate and master's level of education. We base our recommendations on several factors. First, we considered National Accrediting Agency for Clinical Laboratory Sciences guidelines for accreditation of molecular diagnostics programs, because educational programs in clinical laboratory science should obtain its accreditation. Second, the guidelines of several of the best known certifying agencies for clinical laboratory scientists were incorporated into our recommendations. Finally, we relied on feedback from current employers of molecular diagnostics scientists, regarding the skills and knowledge that they believe are essential for clinical scientists who will be performing molecular testing in their laboratories. We have compiled these data into recommendations for a molecular diagnostics curriculum at both the baccalaureate and master's level of education. Copyright © 2014 American Society for Investigative Pathology and the Association for Molecular Pathology. Published by Elsevier Inc. All rights reserved.

A Survey of Established Veterinary Clinical Skills Laboratories from Europe and North America: Present Practices and Recent Developments.

PubMed

Dilly, Marc; Read, Emma K; Baillie, Sarah

Developing competence in clinical skills is important if graduates are to provide entry-level care, but it is dependent on having had sufficient hands-on practice. Clinical skills laboratories provide opportunities for students to learn on simulators and models in a safe environment and to supplement training with animals. Interest in facilities for developing veterinary clinical skills has increased in recent years as many veterinary colleges face challenges in training their students with traditional methods alone. For the present study, we designed a survey to gather information from established veterinary clinical skills laboratories with the aim of assisting others considering opening or expanding their own facility. Data were collated from 16 veterinary colleges in North America and Europe about the uses of their laboratory, the building and associated facilities, and the staffing, budgets, equipment, and supporting learning resources. The findings indicated that having a dedicated veterinary clinical skills laboratory is a relatively new initiative and that colleges have adopted a range of approaches to implementing and running the laboratory, teaching, and assessments. Major strengths were the motivation and positive characteristics of the staff involved, providing open access and supporting self-directed learning. However, respondents widely recognized the increasing demands placed on the facility to provide more space, equipment, and staff. There is no doubt that veterinary clinical skills laboratories are on the increase and provide opportunities to enhance student learning, complement traditional training, and benefit animal welfare.

[Quality use of commercial laboratory for clinical testing services - considering laboratory's role].

PubMed

Ogawa, Shinji

2014-12-01

The number of commercial laboratories for clinical testing in Japan run privately has decreased to about 30 companies, and their business is getting tougher. Branch Lab. and FMS businesses have not expanded recently due to the new reimbursement system which adds an additional sample management fee, becoming effective in 2010. This presentation gives an outline of each role for hospital and commercial laboratories, and their pros & cons considering the current medical situation. Commercial laboratories have investigated how to utilize ICT systems for sharing test information between hospitals and our facilities. It would be very helpful to clarify issues for each hospital. We will develop and create new values for clinical laboratory testing services and forge mutually beneficial relationships with medical institutions. (Review).

[Status of the clinical laboratory in the mandatory postgraduate medical training system. (1) Report from a laboratory technologist].

PubMed

Nishikawa, Yoko

2006-06-01

According to a new system for postgraduate clinical training, 33 medical trainees have been accepted for the past two years at Osaka General Medical Center. Before practicing clinical medicine in each division by a super-rotated table, orientation is scheduled for 5 days to master the basic systems indispensable to the hospital. In this orientation, training in laboratory medicine is performed for 7 hours (3.5 hours for 2 days). Trainees are divided into 4 groups and learn emergency tests of chemistry, hematology and urinalysis, blood transfusion, physiology and microbiology for 60 min each. Laboratory technologists instruct the trainees to gain the basic skills. The main contents are blood gas measuring in chemistry, sample preparation in hematology and urinalysis, taking each other's ECG, ordering blood products for transfusion, serologic study of infectious diseases, and Gram stain in microbiology. Although it is difficult to find time for routine analysis and instructing trainees in the clinical laboratory, it is a suitable opportunity for revision, also for laboratory technologists, and for communication to discuss clinical matters.

Quality management and accreditation in a mixed research and clinical hair testing analytical laboratory setting-a review.

PubMed

Fulga, Netta

2013-06-01

Quality management and accreditation in the analytical laboratory setting are developing rapidly and becoming the standard worldwide. Quality management refers to all the activities used by organizations to ensure product or service consistency. Accreditation is a formal recognition by an authoritative regulatory body that a laboratory is competent to perform examinations and report results. The Motherisk Drug Testing Laboratory is licensed to operate at the Hospital for Sick Children in Toronto, Ontario. The laboratory performs toxicology tests of hair and meconium samples for research and clinical purposes. Most of the samples are involved in a chain of custody cases. Establishing a quality management system and achieving accreditation became mandatory by legislation for all Ontario clinical laboratories since 2003. The Ontario Laboratory Accreditation program is based on International Organization for Standardization 15189-Medical laboratories-Particular requirements for quality and competence, an international standard that has been adopted as a national standard in Canada. The implementation of a quality management system involves management commitment, planning and staff education, documentation of the system, validation of processes, and assessment against the requirements. The maintenance of a quality management system requires control and monitoring of the entire laboratory path of workflow. The process of transformation of a research/clinical laboratory into an accredited laboratory, and the benefits of maintaining an effective quality management system, are presented in this article.

Target volume and artifact evaluation of a new data-driven 4D CT.

PubMed

Martin, Rachael; Pan, Tinsu

Four-dimensional computed tomography (4D CT) is often used to define the internal gross target volume (IGTV) for radiation therapy of lung cancer. Traditionally, this technique requires the use of an external motion surrogate; however, a new image, data-driven 4D CT, has become available. This study aims to describe this data-driven 4D CT and compare target contours created with it to those created using standard 4D CT. Cine CT data of 35 patients undergoing stereotactic body radiation therapy were collected and sorted into phases using standard and data-driven 4D CT. IGTV contours were drawn using a semiautomated method on maximum intensity projection images of both 4D CT methods. Errors resulting from reproducibility of the method were characterized. A comparison of phase image artifacts was made using a normalized cross-correlation method that assigned a score from +1 (data-driven "better") to -1 (standard "better"). The volume difference between the data-driven and standard IGTVs was not significant (data driven was 2.1 ± 1.0% smaller, P = .08). The Dice similarity coefficient showed good similarity between the contours (0.949 ± 0.006). The mean surface separation was 0.4 ± 0.1 mm and the Hausdorff distance was 3.1 ± 0.4 mm. An average artifact score of +0.37 indicated that the data-driven method had significantly fewer and/or less severe artifacts than the standard method (P = 1.5 × 10 -5 for difference from 0). On average, the difference between IGTVs derived from data-driven and standard 4D CT was not clinically relevant or statistically significant, suggesting data-driven 4D CT can be used in place of standard 4D CT without adjustments to IGTVs. The relatively large differences in some patients were usually attributed to limitations in automatic contouring or differences in artifacts. Artifact reduction and setup simplicity suggest a clinical advantage to data-driven 4D CT. Published by Elsevier Inc.

Clinical and laboratory assessment of dehydration severity in children with acute gastroenteritis.

PubMed

Parkin, Patricia C; Macarthur, Colin; Khambalia, Amina; Goldman, Ran D; Friedman, Jeremy N

2010-03-01

To evaluate clinical and laboratory assessment of dehydration severity in children, 1 to 36 months, with acute gastroenteritis. Clinical and laboratory measures and weight change following rehydration were collected for enrolled children. Pediatric emergency department. Likelihood ratio (LR+) and 95% confidence interval (CI): for a clinical score of 0, the LR+ was 2.2 (95% CI = 0.9-5.3); for a clinical score of 1 to 4, the LR+ was 1.3 (95% CI = 0.90-1.74); for a clinical score of 5 to 8, the LR+ was 5.2 (95% CI = 2.2-12.8); for a venous pH <7.32, the LR+ was 7.2 (95% CI = 2.4-21.9); and for serum bicarbonate <18 mmol/L, the LR+ was 11.6 (95% CI = 3.5-38.0). Clinicians may find it useful to incorporate the Clinical Dehydration Scale and laboratory measures into clinical decision-making algorithms to assess dehydration severity in children with acute gastroenteritis.

Agile Acceptance Test–Driven Development of Clinical Decision Support Advisories: Feasibility of Using Open Source Software

PubMed Central

Baldwin, Krystal L; Kannan, Vaishnavi; Flahaven, Emily L; Parks, Cassandra J; Ott, Jason M; Willett, Duwayne L

2018-01-01

Background Moving to electronic health records (EHRs) confers substantial benefits but risks unintended consequences. Modern EHRs consist of complex software code with extensive local configurability options, which can introduce defects. Defects in clinical decision support (CDS) tools are surprisingly common. Feasible approaches to prevent and detect defects in EHR configuration, including CDS tools, are needed. In complex software systems, use of test–driven development and automated regression testing promotes reliability. Test–driven development encourages modular, testable design and expanding regression test coverage. Automated regression test suites improve software quality, providing a “safety net” for future software modifications. Each automated acceptance test serves multiple purposes, as requirements (prior to build), acceptance testing (on completion of build), regression testing (once live), and “living” design documentation. Rapid-cycle development or “agile” methods are being successfully applied to CDS development. The agile practice of automated test–driven development is not widely adopted, perhaps because most EHR software code is vendor-developed. However, key CDS advisory configuration design decisions and rules stored in the EHR may prove amenable to automated testing as “executable requirements.” Objective We aimed to establish feasibility of acceptance test–driven development of clinical decision support advisories in a commonly used EHR, using an open source automated acceptance testing framework (FitNesse). Methods Acceptance tests were initially constructed as spreadsheet tables to facilitate clinical review. Each table specified one aspect of the CDS advisory’s expected behavior. Table contents were then imported into a test suite in FitNesse, which queried the EHR database to automate testing. Tests and corresponding CDS configuration were migrated together from the development environment to production, with tests becoming part of the production regression test suite. Results We used test–driven development to construct a new CDS tool advising Emergency Department nurses to perform a swallowing assessment prior to administering oral medication to a patient with suspected stroke. Test tables specified desired behavior for (1) applicable clinical settings, (2) triggering action, (3) rule logic, (4) user interface, and (5) system actions in response to user input. Automated test suite results for the “executable requirements” are shown prior to building the CDS alert, during build, and after successful build. Conclusions Automated acceptance test–driven development and continuous regression testing of CDS configuration in a commercial EHR proves feasible with open source software. Automated test–driven development offers one potential contribution to achieving high-reliability EHR configuration. Vetting acceptance tests with clinicians elicits their input on crucial configuration details early during initial CDS design and iteratively during rapid-cycle optimization. PMID:29653922

Agile Acceptance Test-Driven Development of Clinical Decision Support Advisories: Feasibility of Using Open Source Software.

PubMed

Basit, Mujeeb A; Baldwin, Krystal L; Kannan, Vaishnavi; Flahaven, Emily L; Parks, Cassandra J; Ott, Jason M; Willett, Duwayne L

2018-04-13

Moving to electronic health records (EHRs) confers substantial benefits but risks unintended consequences. Modern EHRs consist of complex software code with extensive local configurability options, which can introduce defects. Defects in clinical decision support (CDS) tools are surprisingly common. Feasible approaches to prevent and detect defects in EHR configuration, including CDS tools, are needed. In complex software systems, use of test-driven development and automated regression testing promotes reliability. Test-driven development encourages modular, testable design and expanding regression test coverage. Automated regression test suites improve software quality, providing a "safety net" for future software modifications. Each automated acceptance test serves multiple purposes, as requirements (prior to build), acceptance testing (on completion of build), regression testing (once live), and "living" design documentation. Rapid-cycle development or "agile" methods are being successfully applied to CDS development. The agile practice of automated test-driven development is not widely adopted, perhaps because most EHR software code is vendor-developed. However, key CDS advisory configuration design decisions and rules stored in the EHR may prove amenable to automated testing as "executable requirements." We aimed to establish feasibility of acceptance test-driven development of clinical decision support advisories in a commonly used EHR, using an open source automated acceptance testing framework (FitNesse). Acceptance tests were initially constructed as spreadsheet tables to facilitate clinical review. Each table specified one aspect of the CDS advisory's expected behavior. Table contents were then imported into a test suite in FitNesse, which queried the EHR database to automate testing. Tests and corresponding CDS configuration were migrated together from the development environment to production, with tests becoming part of the production regression test suite. We used test-driven development to construct a new CDS tool advising Emergency Department nurses to perform a swallowing assessment prior to administering oral medication to a patient with suspected stroke. Test tables specified desired behavior for (1) applicable clinical settings, (2) triggering action, (3) rule logic, (4) user interface, and (5) system actions in response to user input. Automated test suite results for the "executable requirements" are shown prior to building the CDS alert, during build, and after successful build. Automated acceptance test-driven development and continuous regression testing of CDS configuration in a commercial EHR proves feasible with open source software. Automated test-driven development offers one potential contribution to achieving high-reliability EHR configuration. Vetting acceptance tests with clinicians elicits their input on crucial configuration details early during initial CDS design and iteratively during rapid-cycle optimization. ©Mujeeb A Basit, Krystal L Baldwin, Vaishnavi Kannan, Emily L Flahaven, Cassandra J Parks, Jason M Ott, Duwayne L Willett. Originally published in JMIR Medical Informatics (http://medinform.jmir.org), 13.04.2018.

Clinical proteomics-driven precision medicine for targeted cancer therapy: current overview and future perspectives.

PubMed

Zhou, Li; Wang, Kui; Li, Qifu; Nice, Edouard C; Zhang, Haiyuan; Huang, Canhua

2016-01-01

Cancer is a common disease that is a leading cause of death worldwide. Currently, early detection and novel therapeutic strategies are urgently needed for more effective management of cancer. Importantly, protein profiling using clinical proteomic strategies, with spectacular sensitivity and precision, offer excellent promise for the identification of potential biomarkers that would direct the development of targeted therapeutic anticancer drugs for precision medicine. In particular, clinical sample sources, including tumor tissues and body fluids (blood, feces, urine and saliva), have been widely investigated using modern high-throughput mass spectrometry-based proteomic approaches combined with bioinformatic analysis, to pursue the possibilities of precision medicine for targeted cancer therapy. Discussed in this review are the current advantages and limitations of clinical proteomics, the available strategies of clinical proteomics for the management of precision medicine, as well as the challenges and future perspectives of clinical proteomics-driven precision medicine for targeted cancer therapy.

Costs of HIV/AIDS outpatient services delivered through Zambian public health facilities.

PubMed

Bratt, John H; Torpey, Kwasi; Kabaso, Mushota; Gondwe, Yebo

2011-01-01

To present evidence on unit and total costs of outpatient HIV/AIDS services in ZPCT-supported facilities in Zambia; specifically, to measure unit costs of selected outpatient HIV/AIDS services, and to estimate total annual costs of antiretroviral therapy (ART) and prevention of mother-to-child transmission (PMTCT) in Zambia. Cost data from 2008 were collected in 12 ZPCT-supported facilities (hospitals and health centres) in four provinces. Costs of all resources used to produce ART, PMTCT and CT visits were included, using the perspective of the provider. All shared costs were distributed to clinic visits using appropriate allocation variables. Estimates of annual costs of HIV/AIDS services were made using ZPCT and Ministry of Health data on numbers of persons receiving services in 2009. Unit costs of visits were driven by costs of drugs, laboratory tests and clinical labour, while variability in visit costs across facilities was explained mainly by differences in utilization. First-year costs of ART per client ranged from US$278 to US$523 depending on drug regimen and facility type; costs of a complete course of antenatal care (ANC) including PMTCT were approximately US$114. Annual costs of ART provided in ZPCT-supported facilities were estimated at US$14.7-$40.1 million depending on regimen, and annual costs of antenatal care including PMTCT were estimated at US$16 million. In Zambia as a whole, the respective estimates were US$41.0-114.2 million for ART and US$57.7 million for ANC including PMTCT. Consistent with the literature, total costs of services were dominated by drugs, laboratory tests and clinical labour. For each visit type, variability across facilities in total costs and cost components suggests that some potential exists to reduce costs through greater harmonization of care protocols and more intensive use of fixed resources. Improving facility-level information on the costs of resources used to produce services should be emphasized as an element of health systems strengthening. © 2010 Blackwell Publishing Ltd.

Caught in Their Tracks

ERIC Educational Resources Information Center

Pacifici, Lara

2008-01-01

By allowing students to develop and conduct research on biological or environmental problems they identify themselves, students gain a higher level of understanding and appreciation for science. To this end, teachers should incorporate student-driven research in biology and environmental science classes in lieu of cookbook laboratory activities…

PV system field experience and reliability

NASA Astrophysics Data System (ADS)

Durand, Steven; Rosenthal, Andrew; Thomas, Mike

1997-02-01

Hybrid power systems consisting of battery inverters coupled with diesel, propane, or gasoline engine-driven electrical generators, and photovoltaic arrays are being used in many remote locations. The potential cost advantages of hybrid systems over simple engine-driven generator systems are causing hybrid systems to be considered for numerous applications including single-family residential, communications, and village power. This paper discusses the various design constraints of such systems and presents one technique for reducing hybrid system losses. The Southwest Technology Development Institute under contract to the National Renewable Energy Laboratory and Sandia National Laboratories has been installing data acquisition systems (DAS) on a number of small and large hybrid PV systems. These systems range from small residential systems (1 kW PV - 7 kW generator), to medium sized systems (10 kW PV - 20 kW generator), to larger systems (100 kW PV - 200 kW generator). Even larger systems are being installed with hundreds of kilowatts of PV modules, multiple wind machines, and larger diesel generators.

Dehydration-driven stress transfer triggers intermediate-depth earthquakes

PubMed Central

Ferrand, Thomas P.; Hilairet, Nadège; Incel, Sarah; Deldicque, Damien; Labrousse, Loïc; Gasc, Julien; Renner, Joerg; Wang, Yanbin; Green II, Harry W.; Schubnel, Alexandre

2017-01-01

Intermediate-depth earthquakes (30–300 km) have been extensively documented within subducting oceanic slabs, but their mechanics remains enigmatic. Here we decipher the mechanism of these earthquakes by performing deformation experiments on dehydrating serpentinized peridotites (synthetic antigorite-olivine aggregates, minerals representative of subduction zones lithologies) at upper mantle conditions. At a pressure of 1.1 gigapascals, dehydration of deforming samples containing only 5 vol% of antigorite suffices to trigger acoustic emissions, a laboratory-scale analogue of earthquakes. At 3.5 gigapascals, acoustic emissions are recorded from samples with up to 50 vol% of antigorite. Experimentally produced faults, observed post-mortem, are sealed by fluid-bearing micro-pseudotachylytes. Microstructural observations demonstrate that antigorite dehydration triggered dynamic shear failure of the olivine load-bearing network. These laboratory analogues of intermediate-depth earthquakes demonstrate that little dehydration is required to trigger embrittlement. We propose an alternative model to dehydration-embrittlement in which dehydration-driven stress transfer, rather than fluid overpressure, causes embrittlement. PMID:28504263

Dehydration-driven stress transfer triggers intermediate-depth earthquakes

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ferrand, Thomas P.; Hilairet, Nadège; Incel, Sarah

Intermediate-depth earthquakes (30–300 km) have been extensively documented within subducting oceanic slabs, but their mechanics remains enigmatic. Here in this paper we decipher the mechanism of these earthquakes by performing deformation experiments on dehydrating serpentinized peridotites (synthetic antigorite-olivine aggregates, minerals representative of subduction zones lithologies) at upper mantle conditions. At a pressure of 1.1 gigapascals, dehydration of deforming samples containing only 5 vol% of antigorite suffices to trigger acoustic emissions, a laboratory-scale analogue of earthquakes. At 3.5 gigapascals, acoustic emissions are recorded from samples with up to 50 vol% of antigorite. Experimentally produced faults, observed post-mortem, are sealed by fluid-bearingmore » micro-pseudotachylytes. Microstructural observations demonstrate that antigorite dehydration triggered dynamic shear failure of the olivine load-bearing network. These laboratory analogues of intermediatedepth earthquakes demonstrate that little dehydration is required to trigger embrittlement. We propose an alternative model to dehydration-embrittlement in which dehydration-driven stress transfer, rather than fluid overpressure, causes embrittlement.« less

Dehydration-driven stress transfer triggers intermediate-depth earthquakes

DOE PAGES

Ferrand, Thomas P.; Hilairet, Nadège; Incel, Sarah; ...

2017-05-15

Intermediate-depth earthquakes (30–300 km) have been extensively documented within subducting oceanic slabs, but their mechanics remains enigmatic. Here in this paper we decipher the mechanism of these earthquakes by performing deformation experiments on dehydrating serpentinized peridotites (synthetic antigorite-olivine aggregates, minerals representative of subduction zones lithologies) at upper mantle conditions. At a pressure of 1.1 gigapascals, dehydration of deforming samples containing only 5 vol% of antigorite suffices to trigger acoustic emissions, a laboratory-scale analogue of earthquakes. At 3.5 gigapascals, acoustic emissions are recorded from samples with up to 50 vol% of antigorite. Experimentally produced faults, observed post-mortem, are sealed by fluid-bearingmore » micro-pseudotachylytes. Microstructural observations demonstrate that antigorite dehydration triggered dynamic shear failure of the olivine load-bearing network. These laboratory analogues of intermediatedepth earthquakes demonstrate that little dehydration is required to trigger embrittlement. We propose an alternative model to dehydration-embrittlement in which dehydration-driven stress transfer, rather than fluid overpressure, causes embrittlement.« less

Designs and Plans for MAIZE: a 1 MA LTD-Driven Z-Pinch

NASA Astrophysics Data System (ADS)

Gilgenbach, R. M.; Gomez, M. R.; Zier, J.; Tang, W.; French, D. M.; Hoff, B. W.; Jordan, N.; Cruz, E.; Lau, Y. Y.; Fowler-Guzzardo, T.; Meisel, J.; Mazarakis, M. G.; Cuneo, M. E.; Johnston, M. D.; Mehlhorn, T. A.; Kim, A. A.; Sinebryukhov, V. A.

2007-11-01

We present designs and experimental plans of the first 1 MA z-pinch in the USA to be driven by a Linear Transformer Driver (LTD). The Michigan Accelerator for Inductive Z-pinch Experiments, (MAIZE), is based on the LTD developed at the Institute for High Current Electronics, utilizing 80 capacitors and 40 spark gap switches to deliver a 1 MA, 100 kV pulse with <100 ns risetime. Designs will be presented of a low-inductance MITL terminated in a wire-array z-pinch. Initial, planned experiments will evaluate the LTD driving time-changing inductance of imploding 4-16 wire-array z-pinches. Wire ablation dynamics, axial-correlations and instability development will be explored. *This work was supported by U. S. DoE through Sandia National Laboratories award number 240985 to the University of Michigan. Sandia is a multiprogram laboratory operated by Sandia Corporation, a Lockheed Martin Company, for the United States Department of Energy's National Nuclear Security Administration under Contract DE-AC04-94AL85000.

Student decision making in large group discussion

NASA Astrophysics Data System (ADS)

Kustusch, Mary Bridget; Ptak, Corey; Sayre, Eleanor C.; Franklin, Scott V.

2015-04-01

It is increasingly common in physics classes for students to work together to solve problems and perform laboratory experiments. When students work together, they need to negotiate the roles and decision making within the group. We examine how a large group of students negotiates authority as part of their two week summer College Readiness Program at Rochester Institute of Technology. The program is designed to develop metacognitive skills in first generation and Deaf and hard-of-hearing (DHH) STEM undergraduates through cooperative group work, laboratory experimentation, and explicit reflection exercises. On the first full day of the program, the students collaboratively developed a sign for the word ``metacognition'' for which there is not a sign in American Sign Language. This presentation will focus on three aspects of the ensuing discussion: (1) how the instructor communicated expectations about decision making; (2) how the instructor promoted student-driven decision making rather than instructor-driven policy; and (3) one student's shifts in decision making behavior. We conclude by discussing implications of this research for activity-based physics instruction.

42 CFR 414.509 - Reconsideration of basis for and amount of payment for a new clinical diagnostic laboratory test.

Code of Federal Regulations, 2013 CFR

2013-10-01

...) or § 414.509(a)(3) that the basis for payment for a new test will be gapfilling, CMS posts interim... for a new clinical diagnostic laboratory test. 414.509 Section 414.509 Public Health CENTERS FOR... Laboratory Tests § 414.509 Reconsideration of basis for and amount of payment for a new clinical diagnostic...

Reasons for Ineligibility in Phase 1 and 2A HIV Vaccine Clinical Trials at Kenya Aids Vaccine Initiative (KAVI), Kenya

PubMed Central

Omosa-Manyonyi, Gloria S.; Jaoko, Walter; Anzala, Omu; Ogutu, Hilda; Wakasiaka, Sabina; Malogo, Roselyn; Nyange, Jacqueline; Njuguna, Pamela; Ndinya-Achola, Jeckoniah; Bhatt, Kirana; Farah, Bashir; Oyaro, Micah; Schmidt, Claudia; Priddy, Frances; Fast, Patricia

2011-01-01

Background With the persistent challenges towards controlling the HIV epidemic, there is an ongoing need for research into HIV vaccines and drugs. Sub-Saharan African countries - worst affected by the HIV pandemic - have participated in the conduct of clinical trials for HIV vaccines. In Kenya, the Kenya AIDS Vaccine Initiative (KAVI) at the University of Nairobi has conducted HIV vaccine clinical trials since 2001. Methodology Participants were recruited after an extensive informed consent process followed by screening to determine eligibility. Screening included an assessment of risk behavior, medical history and physical examination, and if clinically healthy, laboratory testing. In the absence of locally derived laboratory reference ranges, the ranges used in these trials were derived from populations in the West. Principal findings Two hundred eighty-one participants were screened between 2003 and 2006 for two clinical trials. Of these, 167 (59.4%) met the inclusion/exclusion criteria. Overall, laboratory abnormalities based on the non-indigenous laboratory references used were the most frequent reasons (61.4%) for ineligibility. Medical abnormalities contributed 30.7% of the total reasons for ineligibility. Based on the laboratory reference intervals now developed from East and Southern Africa, those ineligible due to laboratory abnormalities would have been 46.3%. Of the eligible participants, 18.6% declined enrolment. Conclusions Participant recruitment for HIV vaccine clinical trials is a rigorous and time-consuming exercise. Over 61% of the screening exclusions in clinically healthy people were due to laboratory abnormalities. It is essential that laboratory reference ranges generated from local populations for laboratory values be used in the conduct of clinical trials to avoid unnecessary exclusion of willing participants and to avoid over-reporting of adverse events for enrolled participants. Trial registration Protocol IAVI VRC V001 [1]. ClinicalTrials.gov NCT00124007 Protocol IAVI 010 [2] (registration with ClincalTrials.gov is in progress) Protocols IAVI 002 and IAVI 004 are Phase 1 trials only mentioned in introductory paragraphs; details will not be reported. Registration was not required when they were conducted. PMID:21283743

Using the e-Chasqui, web-based information system, to determine laboratory guidelines and data available to clinical staff.

PubMed

Blaya, Joaquin A; Yagui, Martin; Contreras, Carmen C; Palma, Betty; Shin, Sonya S; Yale, Gloria; Suarez, Carmen; Fraser, Hamish S F

2008-11-06

13% of all drug susceptibility tests (DSTs) performed at a public laboratory in Peru were duplicate. To determine reasons for duplicate requests an online survey was implemented in the e-Chasqui laboratory information system. Results showed that 59.6% of tests were ordered because clinical staff was unaware of ordering guidelines or of a previous result. This shows a benefit of using a web-based system and the lack of laboratory information available to clinical staff in Peru.

Guiding of relativistic electron beams in dense matter by laser-driven magnetostatic fields.

PubMed

Bailly-Grandvaux, M; Santos, J J; Bellei, C; Forestier-Colleoni, P; Fujioka, S; Giuffrida, L; Honrubia, J J; Batani, D; Bouillaud, R; Chevrot, M; Cross, J E; Crowston, R; Dorard, S; Dubois, J-L; Ehret, M; Gregori, G; Hulin, S; Kojima, S; Loyez, E; Marquès, J-R; Morace, A; Nicolaï, Ph; Roth, M; Sakata, S; Schaumann, G; Serres, F; Servel, J; Tikhonchuk, V T; Woolsey, N; Zhang, Z

2018-01-09

Intense lasers interacting with dense targets accelerate relativistic electron beams, which transport part of the laser energy into the target depth. However, the overall laser-to-target energy coupling efficiency is impaired by the large divergence of the electron beam, intrinsic to the laser-plasma interaction. Here we demonstrate that an efficient guiding of MeV electrons with about 30 MA current in solid matter is obtained by imposing a laser-driven longitudinal magnetostatic field of 600 T. In the magnetized conditions the transported energy density and the peak background electron temperature at the 60-μm-thick target's rear surface rise by about a factor of five, as unfolded from benchmarked simulations. Such an improvement of energy-density flux through dense matter paves the ground for advances in laser-driven intense sources of energetic particles and radiation, driving matter to extreme temperatures, reaching states relevant for planetary or stellar science as yet inaccessible at the laboratory scale and achieving high-gain laser-driven thermonuclear fusion.

What are the most effective strategies for improving quality and safety of health care?

PubMed

Scott, I

2009-06-01

There is now a plethora of different quality improvement strategies (QIS) for optimizing health care, some clinician/patient driven, others manager/policy-maker driven. Which of these are most effective remains unclear despite expressed concerns about potential for QIS-related patient harm and wasting of resources. The objective of this study was to review published literature assessing the relative effectiveness of different QIS. Data sources comprising PubMed Clinical Queries, Cochrane Library and its Effective Practice and Organization of Care database, and HealthStar were searched for studies of QIS between January 1985 and February 2008 using search terms based on an a priori QIS classification suggested by experts. Systematic reviews of controlled trials were selected in determining effect sizes for specific QIS, which were compared as a narrative meta-review. Clinician/patient driven QIS were associated with stronger evidence of efficacy and larger effect sizes than manager/policy-maker driven QIS. The most effective strategies (>10% absolute increase in appropriate care or equivalent measure) included clinician-directed audit and feedback cycles, clinical decision support systems, specialty outreach programmes, chronic disease management programmes, continuing professional education based on interactive small-group case discussions, and patient-mediated clinician reminders. Pay-for-performance schemes directed to clinician groups and organizational process redesign were modestly effective. Other manager/policy-maker driven QIS including continuous quality improvement programmes, risk and safety management systems, public scorecards and performance reports, external accreditation, and clinical governance arrangements have not been adequately evaluated with regard to effectiveness. QIS are heterogeneous and methodological flaws in much of the evaluative literature limit validity and generalizability of results. Based on current best available evidence, clinician/patient driven QIS appear to be more effective than manager/policy-maker driven QIS although the latter have, in many instances, attracted insufficient robust evaluations to accurately determine their comparative effectiveness.

42 CFR 493.1225 - Condition: Clinical cytogenetics.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Condition: Clinical cytogenetics. 493.1225 Section... Testing § 493.1225 Condition: Clinical cytogenetics. If the laboratory provides services in the specialty of Clinical cytogenetics, the laboratory must meet the requirements specified in §§ 493.1230 through...

42 CFR 493.1461 - Standard: General supervisor qualifications.

Code of Federal Regulations, 2012 CFR

2012-10-01

... chemical, physical, biological or clinical laboratory science, or medical technology from an accredited... proficiency examination for technologist given by HHS between March 1, 1986 and December 31, 1987, qualifies... medical laboratory or clinical laboratory training program approved or accredited by the Accrediting...

42 CFR 493.1461 - Standard: General supervisor qualifications.

Code of Federal Regulations, 2010 CFR

2010-10-01

... chemical, physical, biological or clinical laboratory science, or medical technology from an accredited... proficiency examination for technologist given by HHS between March 1, 1986 and December 31, 1987, qualifies... medical laboratory or clinical laboratory training program approved or accredited by the Accrediting...

42 CFR 493.1461 - Standard: General supervisor qualifications.

Code of Federal Regulations, 2013 CFR

2013-10-01

... chemical, physical, biological or clinical laboratory science, or medical technology from an accredited... proficiency examination for technologist given by HHS between March 1, 1986 and December 31, 1987, qualifies... medical laboratory or clinical laboratory training program approved or accredited by the Accrediting...

42 CFR 493.1461 - Standard: General supervisor qualifications.

Code of Federal Regulations, 2011 CFR

2011-10-01

... chemical, physical, biological or clinical laboratory science, or medical technology from an accredited... proficiency examination for technologist given by HHS between March 1, 1986 and December 31, 1987, qualifies... medical laboratory or clinical laboratory training program approved or accredited by the Accrediting...

42 CFR 493.1461 - Standard: General supervisor qualifications.

Code of Federal Regulations, 2014 CFR

2014-10-01

... chemical, physical, biological or clinical laboratory science, or medical technology from an accredited... proficiency examination for technologist given by HHS between March 1, 1986 and December 31, 1987, qualifies... medical laboratory or clinical laboratory training program approved or accredited by the Accrediting...

The intelligent clinical laboratory as a tool to increase cancer care management productivity.

PubMed

Mohammadzadeh, Niloofar; Safdari, Reza

2014-01-01

Studies of the causes of cancer, early detection, prevention or treatment need accurate, comprehensive, and timely cancer data. The clinical laboratory provides important cancer information needed for physicians which influence clinical decisions regarding treatment, diagnosis and patient monitoring. Poor communication between health care providers and clinical laboratory personnel can lead to medical errors and wrong decisions in providing cancer care. Because of the key impact of laboratory information on cancer diagnosis and treatment the quality of the tests, lab reports, and appropriate lab management are very important. A laboratory information management system (LIMS) can have an important role in diagnosis, fast and effective access to cancer data, decrease redundancy and costs, and facilitate the integration and collection of data from different types of instruments and systems. In spite of significant advantages LIMS is limited by factors such as problems in adaption to new instruments that may change existing work processes. Applications of intelligent software simultaneously with existing information systems, in addition to remove these restrictions, have important benefits including adding additional non-laboratory-generated information to the reports, facilitating decision making, and improving quality and productivity of cancer care services. Laboratory systems must have flexibility to change and have the capability to develop and benefit from intelligent devices. Intelligent laboratory information management systems need to benefit from informatics tools and latest technologies like open sources. The aim of this commentary is to survey application, opportunities and necessity of intelligent clinical laboratory as a tool to increase cancer care management productivity.

Tomato-based food products for prostate cancer prevention: what have we learned?

PubMed

Tan, Hsueh-Li; Thomas-Ahner, Jennifer M; Grainger, Elizabeth M; Wan, Lei; Francis, David M; Schwartz, Steven J; Erdman, John W; Clinton, Steven K

2010-09-01

Evidence derived from a vast array of laboratory studies and epidemiological investigations have implicated diets rich in fruits and vegetables with a reduced risk of certain cancers. However, these approaches cannot demonstrate causal relationships and there is a paucity of randomized, controlled trials due to the difficulties involved with executing studies of food and behavioral change. Rather than pursuing the definitive intervention trials that are necessary, the thrust of research in recent decades has been driven by a reductionist approach focusing upon the identification of bioactive components in fruits and vegetables with the subsequent development of single agents using a pharmacologic approach. At this point in time, there are no chemopreventive strategies that are standard of care in medical practice that have resulted from this approach. This review describes an alternative approach focusing upon development of tomato-based food products for human clinical trials targeting cancer prevention and as an adjunct to therapy. Tomatoes are a source of bioactive phytochemicals and are widely consumed. The phytochemical pattern of tomato products can be manipulated to optimize anticancer activity through genetics, horticultural techniques, and food processing. The opportunity to develop a highly consistent tomato-based food product rich in anticancer phytochemicals for clinical trials targeting specific cancers, particularly the prostate, necessitates the interactive transdisciplinary research efforts of horticulturalists, food technologists, cancer biologists, and clinical translational investigators.

Tomato-based food products for prostate cancer prevention: what have we learned?

PubMed Central

Tan, Hsueh-Li; Thomas-Ahner, Jennifer M.; Grainger, Elizabeth M.; Wan, Lei; Francis, David M.; Schwartz, Steven J.; Erdman, John W.

2013-01-01

Evidence derived from a vast array of laboratory studies and epidemiological investigations have implicated diets rich in fruits and vegetables with a reduced risk of certain cancers. However, these approaches cannot demonstrate causal relationships and there is a paucity of randomized, controlled trials due to the difficulties involved with executing studies of food and behavioral change. Rather than pursuing the definitive intervention trials that are necessary, the thrust of research in recent decades has been driven by a reductionist approach focusing upon the identification of bioactive components in fruits and vegetables with the subsequent development of single agents using a pharmacologic approach. At this point in time, there are no chemopreventive strategies that are standard of care in medical practice that have resulted from this approach. This review describes an alternative approach focusing upon development of tomato-based food products for human clinical trials targeting cancer prevention and as an adjunct to therapy. Tomatoes are a source of bioactive phytochemicals and are widely consumed. The phytochemical pattern of tomato products can be manipulated to optimize anticancer activity through genetics, horticultural techniques, and food processing. The opportunity to develop a highly consistent tomato-based food product rich in anticancer phytochemicals for clinical trials targeting specific cancers, particularly the prostate, necessitates the interactive transdisciplinary research efforts of horticulturalists, food technologists, cancer biologists, and clinical translational investigators. PMID:20803054

Health and safety in clinical laboratories in developing countries: safety considerations.

PubMed

Ejilemele, A A; Ojule, A C

2004-01-01

Clinical laboratories are potentially hazardous work areas. Health and safety in clinical laboratories is becoming an increasingly important subject as a result of the emergence of highly infectious diseases such as hepatitis and HIV. This is even more so in developing countries where health and safety have traditionally been regarded as low priority issues, considering the more important health problems confronting the health authorities in these countries. We conducted a literature search using the medical subheadings titles on the INTERNET over a period of twenty years and summarized our findings. This article identifies hazards in the laboratories and highlights measures to make the laboratory a safer work place. It also emphasizes the mandatory obligations of employers and employees towards the attainment of acceptable safety standards in clinical laboratories in Third World countries in the face of the current HIV/AIDS epidemic in many of these developing countries especially in the sub-Saharan Africa while accommodating the increasing work load in these laboratories. Both the employer and the employee have major roles to play in the maintenance of a safe working environment. This can be achieved if measures discussed are incorporated into everyday laboratory practice.

Validity of thermally-driven small-scale ventilated filling box models

NASA Astrophysics Data System (ADS)

Partridge, Jamie L.; Linden, P. F.

2013-11-01

The majority of previous work studying building ventilation flows at laboratory scale have used saline plumes in water. The production of buoyancy forces using salinity variations in water allows dynamic similarity between the small-scale models and the full-scale flows. However, in some situations, such as including the effects of non-adiabatic boundaries, the use of a thermal plume is desirable. The efficacy of using temperature differences to produce buoyancy-driven flows representing natural ventilation of a building in a small-scale model is examined here, with comparison between previous theoretical and new, heat-based, experiments.

[Mandibular-driven simultaneous maxillo-mandibular distraction for hemifacial microsomia with rapid prototyping technology].

PubMed

Gao, Quan-Wen; Song, Hui-Feng; Xu, Ming-Huo; Liu, Chun-Ming; Chai, Jia-Ke

2013-11-01

To explore the clinical application of mandibular-driven simultaneous maxillo-mandihular distraction to correct hemifacial microsomia with rapid prototyping technology. The patient' s skull resin model was manufactured with rapid prototyping technology. The osteotomy was designed on skull resin model. According to the preoperative design, the patients underwent Le Fort I osteotomy and mandibular ramus osteotomy. The internal mandible distractor was embedded onto the osteotomy position. The occlusal titanium pin was implanted. Distraction were carried out by mandibular-driven simultaneous maxillo-mandihular distraction 5 days after operation. The distraction in five patients was complete as designed. No infection and dysosteogenesis happened. The longest distance of distraction was 28 mm, and the shortest distance was 16 mm. The facial asymmetry deformity was significantly improved at the end of distraction. The ocelusal plane of patients obviously improved. Rapid prototyping technology is helpful to design precisely osteotomy before operation. Mandibular-driven simultaneous maxillo-mandibular distraction can correct hemifacial microsomia. It is worth to clinical application.

[Postgraduate training program in laboratory medicine at a clinical teaching hospital].

PubMed

Matsuo, Shuji

2003-04-01

The Tenri Hospital resident system was introduced in 1976 and the training program for laboratory medicine began in 1982. Thus, the author proposes goals for the the future on the basis of experience. It is appropriate that trainees study emergency tests, blood transfusion and microbiology(particularly Gram's stain and sputum culture) as practical matters, and in addition to these, learn how to reply to consultations from physicians, learn the laboratory flow(so-called laboratory system), and announce interpretations of laboratory data at reversed clinical pathological conference(R-CPC). The objectives of these training programs are to gain skills for appropriate laboratory utilization and interpretation, and develop communications and consultations with clinical pathologists and medical technologists. The key points of success in the training are close cooperation of the laboratory and teaching divisions. Particularly, cooperation with medical technologists is necessary, and it is essential medical practice for trainees because they will have to work with them in future. Finally it should be emphasized that there training has a limited effect because of the short duration. It is thus important to communicate and discuss clinical matters regularly in medicine.

[Study of quality of a branch laboratory--an opinion of a laboratory manager].

PubMed

Yazawa, Naoyuki

2006-11-01

At the stage of establishing a branch laboratory, quality evaluation is extremely difficult. Even the results of a control survey by the headquarters of the branch laboratory are unhelpful. For a clinical laboratory, the most important function is to provide reliable data all the time, and to maintain the reliability of clinical doctors with informed responses. We mostly refer to control surveys and daily quality control data to evaluate a clinical laboratory, but we rarely check its fundamental abilities, such as planning events, preserving statistical data about the standard range, using the right method for quality control and others. This is generally disregarded and it is taken for granted that they will be correct the first time. From my six years of experience working with X's branch laboratory, I realized that there might be some relation between the quality of a branch laboratory and the fundamental abilities of the company itself. I would never argue that all branch laboratories are ineffective, but they should be conscious of fundamental activities. The referring laboratory, not the referral laboratory, should be responsible for ensuring that the referral laboratory's examination results and findings are correct.

The total laboratory solution: a new laboratory E-business model based on a vertical laboratory meta-network.

PubMed

Friedman, B A

2001-08-01

Major forces are now reshaping all businesses on a global basis, including the healthcare and clinical laboratory industries. One of the major forces at work is information technology (IT), which now provides the opportunity to create a new economic and business model for the clinical laboratory industry based on the creation of an integrated vertical meta-network, referred to here as the "total laboratory solution" (TLS). Participants at the most basic level of such a network would include a hospital-based laboratory, a reference laboratory, a laboratory information system/application service provider/laboratory portal vendor, an in vitro diagnostic manufacturer, and a pharmaceutical/biotechnology manufacturer. It is suggested that each of these participants would add value to the network primarily in its area of core competency. Subvariants of such a network have evolved over recent years, but a TLS comprising all or most of these participants does not exist at this time. Although the TLS, enabled by IT and closely akin to the various e-businesses that are now taking shape, offers many advantages from a theoretical perspective over the current laboratory business model, its success will depend largely on (a) market forces, (b) how the collaborative networks are organized and managed, and (c) whether the network can offer healthcare organizations higher quality testing services at lower cost. If the concept is successful, new demands will be placed on hospital-based laboratory professionals to shift the range of professional services that they offer toward clinical consulting, integration of laboratory information from multiple sources, and laboratory information management. These information management and integration tasks can only increase in complexity in the future as new genomic and proteomics testing modalities are developed and come on-line in clinical laboratories.

Explosively driven two-shockwave tools with application to ejecta formation at the Los Alamos National Laboratory Proton Radiography Facility

NASA Astrophysics Data System (ADS)

Buttler, William

2013-06-01

We present the development of an explosively driven physics tool to generate two mostly uniaxial shockwaves. The tool is being used to extend single shockwave ejecta models to a subsequent shockwave event separated by a time interval on the order of a few microseconds. We explore the possibility of varying the amplitude of both the first and second shockwaves, and we apply the tool in experimental geometries on Sn with a surface roughness of Ra = 0 . 8 μ m. We then evaluate the tool further at the Los Alamos National Laboratory Proton Radiography (pRad) Facility in an application to Sn with larger scale perturbations of wavelength 550 μ m, and various amplitudes that gave wave-number amplitude products of η0 2 π / λ = { 3 / 4 , 1 / 2 , 1 / 4 , 1 / 8 } , where the perturbation amplitude is η0, and the wave-number k = 2 π / λ . The pRad data and velocimetry imply it should be possible to develop a second shock ejecta model based on unstable Richtmyer-Meshkov physics. In collaboration with David Oro, Fesseha Mariam, Alexander Saunders, Malcolm Andrews, Frank Cherne, James Hammerberg. Robert Hixson, Christopher Morris, Russell Olson, Dean Preston, Joseph Stone, Dale Tupa, and Wendy Vogan-McNeil, Los Alamos National Laboratory,

JobCenter: an open source, cross-platform, and distributed job queue management system optimized for scalability and versatility.

PubMed

Jaschob, Daniel; Riffle, Michael

2012-07-30

Laboratories engaged in computational biology or bioinformatics frequently need to run lengthy, multistep, and user-driven computational jobs. Each job can tie up a computer for a few minutes to several days, and many laboratories lack the expertise or resources to build and maintain a dedicated computer cluster. JobCenter is a client-server application and framework for job management and distributed job execution. The client and server components are both written in Java and are cross-platform and relatively easy to install. All communication with the server is client-driven, which allows worker nodes to run anywhere (even behind external firewalls or "in the cloud") and provides inherent load balancing. Adding a worker node to the worker pool is as simple as dropping the JobCenter client files onto any computer and performing basic configuration, which provides tremendous ease-of-use, flexibility, and limitless horizontal scalability. Each worker installation may be independently configured, including the types of jobs it is able to run. Executed jobs may be written in any language and may include multistep workflows. JobCenter is a versatile and scalable distributed job management system that allows laboratories to very efficiently distribute all computational work among available resources. JobCenter is freely available at http://code.google.com/p/jobcenter/.

X-ray astronomy in the laboratory with a miniature compact object produced by laser-driven implosion

NASA Astrophysics Data System (ADS)

Fujioka, Shinsuke; Takabe, Hideaki; Yamamoto, Norimasa; Salzmann, David; Wang, Feilu; Nishimura, Hiroaki; Li, Yutong; Dong, Quanli; Wang, Shoujun; Zhang, Yi; Rhee, Yong-Joo; Lee, Yong-Woo; Han, Jae-Min; Tanabe, Minoru; Fujiwara, Takashi; Nakabayashi, Yuto; Zhao, Gang; Zhang, Jie; Mima, Kunioki

2009-11-01

X-ray spectroscopy is an important tool for understanding the extreme photoionization processes that drive the behaviour of non-thermal equilibrium plasmas in compact astrophysical objects such as black holes. Even so, the distance of these objects from the Earth and the inability to control or accurately ascertain the conditions that govern their behaviour makes it difficult to interpret the origin of the features in astronomical X-ray measurements. Here, we describe an experiment that uses the implosion driven by a 3TW, 4kJ laser system to produce a 0.5keV blackbody radiator that mimics the conditions that exist in the neighbourhood of a black hole. The X-ray spectra emitted from photoionized silicon plasmas resemble those observed from the binary stars Cygnus X-3 (refs 7, 8) and Vela X-1 (refs 9, 10 11) with the Chandra X-ray satellite. As well as demonstrating the ability to create extreme radiation fields in a laboratory plasma, our theoretical interpretation of these laboratory spectra contrasts starkly with the generally accepted explanation for the origin of similar features in astronomical observations. Our experimental approach offers a powerful means to test and validate the computer codes used in X-ray astronomy.

The Pitfalls of Companion Diagnostics: Evaluation of Discordant EGFR Mutation Results from a Clinical Laboratory and a Central Laboratory.

PubMed

Turner, Scott A; Peterson, Jason D; Pettus, Jason R; de Abreu, Francine B; Amos, Christopher I; Dragnev, Konstantin H; Tsongalis, Gregory J

2016-05-01

Accurate identification of somatic mutations in formalin-fixed, paraffin-embedded tumor tissue is required for enrollment into clinical trials for many novel targeted therapeutics, including trials requiring EGFR mutation status in non-small-cell lung carcinomas. Central clinical trial laboratories contracted to perform this analysis typically rely on US Food and Drug Administration-approved targeted assays to identify these mutations. We present two cases in which central laboratories inaccurately reported EGFR mutation status because of improper identification and isolation of tumor material and failure to accurately report assay limitations, resulting in enrollment denial. Such cases highlight the need for increased awareness by clinical trials of the limitation of these US Food and Drug Administration-approved assays and the necessity for a mechanism to reevaluate discordant results by alternative laboratory-developed procedures, including clinical next-generation sequencing. Copyright © 2016 American Society for Investigative Pathology and the Association for Molecular Pathology. Published by Elsevier Inc. All rights reserved.

Laboratory automation: total and subtotal.

PubMed

Hawker, Charles D

2007-12-01

Worldwide, perhaps 2000 or more clinical laboratories have implemented some form of laboratory automation, either a modular automation system, such as for front-end processing, or a total laboratory automation system. This article provides descriptions and examples of these various types of automation. It also presents an outline of how a clinical laboratory that is contemplating automation should approach its decision and the steps it should follow to ensure a successful implementation. Finally, the role of standards in automation is reviewed.

The laboratory diagnosis of syphilis.

PubMed

Ratnam, Sam

2005-01-01

Syphilis has several clinical manifestations, making laboratory testing a very important aspect of diagnosis. In North America, many unsuspected cases are discovered by laboratory testing. The etiological agent, Treponema pallidum, cannot be cultured, and there is no single optimal alternative test. Serological testing is the most frequently used approach in the laboratory diagnosis of syphilis. The present paper discusses the various serological and alternative tests currently available along with their limitations, and relates their results to the likely corresponding clinical stage of the disease. The need to use multiple tests is discussed, and the importance of quality control is noted. The complexity of syphilis serology means that the services of reference laboratories and clinical experts are often needed.

Clinical laboratory as an economic model for business performance analysis

PubMed Central

Buljanović, Vikica; Patajac, Hrvoje; Petrovečki, Mladen

2011-01-01

Aim To perform SWOT (strengths, weaknesses, opportunities, and threats) analysis of a clinical laboratory as an economic model that may be used to improve business performance of laboratories by removing weaknesses, minimizing threats, and using external opportunities and internal strengths. Methods Impact of possible threats to and weaknesses of the Clinical Laboratory at Našice General County Hospital business performance and use of strengths and opportunities to improve operating profit were simulated using models created on the basis of SWOT analysis results. The operating profit as a measure of profitability of the clinical laboratory was defined as total revenue minus total expenses and presented using a profit and loss account. Changes in the input parameters in the profit and loss account for 2008 were determined using opportunities and potential threats, and economic sensitivity analysis was made by using changes in the key parameters. The profit and loss account and economic sensitivity analysis were tools for quantifying the impact of changes in the revenues and expenses on the business operations of clinical laboratory. Results Results of simulation models showed that operational profit of €470 723 in 2008 could be reduced to only €21 542 if all possible threats became a reality and current weaknesses remained the same. Also, operational gain could be increased to €535 804 if laboratory strengths and opportunities were utilized. If both the opportunities and threats became a reality, the operational profit would decrease by €384 465. Conclusion The operational profit of the clinical laboratory could be significantly reduced if all threats became a reality and the current weaknesses remained the same. The operational profit could be increased by utilizing strengths and opportunities as much as possible. This type of modeling may be used to monitor business operations of any clinical laboratory and improve its financial situation by implementing changes in the next fiscal period. PMID:21853546

Clinical laboratory as an economic model for business performance analysis.

PubMed

Buljanović, Vikica; Patajac, Hrvoje; Petrovecki, Mladen

2011-08-15

To perform SWOT (strengths, weaknesses, opportunities, and threats) analysis of a clinical laboratory as an economic model that may be used to improve business performance of laboratories by removing weaknesses, minimizing threats, and using external opportunities and internal strengths. Impact of possible threats to and weaknesses of the Clinical Laboratory at Našice General County Hospital business performance and use of strengths and opportunities to improve operating profit were simulated using models created on the basis of SWOT analysis results. The operating profit as a measure of profitability of the clinical laboratory was defined as total revenue minus total expenses and presented using a profit and loss account. Changes in the input parameters in the profit and loss account for 2008 were determined using opportunities and potential threats, and economic sensitivity analysis was made by using changes in the key parameters. The profit and loss account and economic sensitivity analysis were tools for quantifying the impact of changes in the revenues and expenses on the business operations of clinical laboratory. Results of simulation models showed that operational profit of €470 723 in 2008 could be reduced to only €21 542 if all possible threats became a reality and current weaknesses remained the same. Also, operational gain could be increased to €535 804 if laboratory strengths and opportunities were utilized. If both the opportunities and threats became a reality, the operational profit would decrease by €384 465. The operational profit of the clinical laboratory could be significantly reduced if all threats became a reality and the current weaknesses remained the same. The operational profit could be increased by utilizing strengths and opportunities as much as possible. This type of modeling may be used to monitor business operations of any clinical laboratory and improve its financial situation by implementing changes in the next fiscal period.

The laboratory workforce shortage: a managerial perspective.

PubMed

Cortelyou-Ward, Kendall; Ramirez, Bernardo; Rotarius, Timothy

2011-01-01

Most clinical laboratories in the nation report severe difficulties in recruitment and retention of most types of personnel. Other important factors impacting this problem include work complexities, increased automation, and a graying workforce. As a further challenge, institutional needs for clinical laboratory personnel are expected to grow significantly in the next decade. This article examines the current situation of the clinical laboratory workforce. It analyzes the different types of personnel; the managerial, supervision, and line positions that are key for different types of laboratories; the job outlook and recent projections for different types of staff; and the current issues, trends, and challenges of the laboratory workforce. Laboratory managers need to take action with strategies suggested for overcoming these challenges. Most importantly, they need to become transformational leaders by developing effective staffing models, fostering healthy and productive work environments, and creating value with a strategic management culture and implementation of knowledge management.

Laboratory and software applications for clinical trials: the global laboratory environment.

PubMed

Briscoe, Chad

2011-11-01

The Applied Pharmaceutical Software Meeting is held annually. It is sponsored by The Boston Society, a not-for-profit organization that coordinates a series of meetings within the global pharmaceutical industry. The meeting generally focuses on laboratory applications, but in recent years has expanded to include some software applications for clinical trials. The 2011 meeting emphasized the global laboratory environment. Global clinical trials generate massive amounts of data in many locations that must be centralized and processed for efficient analysis. Thus, the meeting had a strong focus on establishing networks and systems for dealing with the computer infrastructure to support such environments. In addition to the globally installed laboratory information management system, electronic laboratory notebook and other traditional laboratory applications, cloud computing is quickly becoming the answer to provide efficient, inexpensive options for managing the large volumes of data and computing power, and thus it served as a central theme for the meeting.

A review of international biobanks and networks: success factors and key benchmarks.

PubMed

Vaught, Jim; Kelly, Andrea; Hewitt, Robert

2009-09-01

Biobanks and biobanking networks are involved in varying degrees in the collection, processing, storage, and dissemination of biological specimens. This review outlines the approaches that 16 of the largest biobanks and biobanking networks in Europe, North America, Australia, and Asia have taken to collecting and distributing human research specimens and managing scientific initiatives while covering operating costs. Many are small operations that exist as either a single or a few freezers in a research laboratory, hospital clinical laboratory, or pathology suite. Larger academic and commercial biobanks operate to support large clinical and epidemiological studies. Operational and business models depend on the medical and research missions of their institutions and home countries. Some national biobanks operate with a centralized physical biobank that accepts samples from multiple locations. Others operate under a "federated" model where each institution maintains its own collections but agrees to list them on a central shared database. Some collections are "project-driven" meaning that specimens are collected and distributed to answer specific research questions. "General" collections are those that exist to establish a reference collection, that is, not to meet particular research goals but to be available to respond to multiple requests for an assortment of research uses. These individual and networked biobanking systems operate under a variety of business models, usually incorporating some form of partial cost recovery, while requiring at least partial public or government funding. Each has a well-defined biospecimen-access policy in place that specifies requirements that must be met-such as ethical clearance and the expertise to perform the proposed experiments-to obtain samples for research. The success of all of these biobanking models depends on a variety of factors including well-defined goals, a solid business plan, and specimen collections that are developed according to strict quality and operational controls.

Argumentation in Undergraduate Chemistry Laboratories

ERIC Educational Resources Information Center

Walker, Joi Phelps

2011-01-01

To address the need for reform in undergraduate science education a new instructional model called "Argument-Driven Inquiry" (ADI) was developed and then implemented in a undergraduate chemistry course at a community college in the southeastern United States (Sampson, Walker, & Grooms, 2009; Walker, Sampson, & Zimmerman, in press). The ADI…

Integration of the NRL Digital Library.

ERIC Educational Resources Information Center

King, James

2001-01-01

The Naval Research Laboratory (NRL) Library has identified six primary areas that need improvement: infrastructure, InfoWeb, TORPEDO Ultra, journal data management, classified data, and linking software. It is rebuilding InfoWeb and TORPEDO Ultra as database-driven Web applications, upgrading the STILAS library catalog, and creating other support…

Consolidated clinical microbiology laboratories.

PubMed

Sautter, Robert L; Thomson, Richard B

2015-05-01

The manner in which medical care is reimbursed in the United States has resulted in significant consolidation in the U.S. health care system. One of the consequences of this has been the development of centralized clinical microbiology laboratories that provide services to patients receiving care in multiple off-site, often remote, locations. Microbiology specimens are unique among clinical specimens in that optimal analysis may require the maintenance of viable organisms. Centralized laboratories may be located hours from patient care settings, and transport conditions need to be such that organism viability can be maintained under a variety of transport conditions. Further, since the provision of rapid results has been shown to enhance patient care, effective and timely means for generating and then reporting the results of clinical microbiology analyses must be in place. In addition, today, increasing numbers of patients are found to have infection caused by pathogens that were either very uncommon in the past or even completely unrecognized. As a result, infectious disease specialists, in particular, are more dependent than ever on access to high-quality diagnostic information from clinical microbiology laboratories. In this point-counterpoint discussion, Robert Sautter, who directs a Charlotte, NC, clinical microbiology laboratory that provides services for a 40-hospital system spread over 3 states in the southeastern United States explains how an integrated clinical microbiology laboratory service has been established in a multihospital system. Richard (Tom) Thomson of the NorthShore University HealthSystem in Evanston, IL, discusses some of the problems and pitfalls associated with large-scale laboratory consolidation. Copyright © 2015, American Society for Microbiology. All Rights Reserved.

Implementation of quality management for clinical bacteriology in low-resource settings.

PubMed

Barbé, B; Yansouni, C P; Affolabi, D; Jacobs, J

2017-07-01

The declining trend of malaria and the recent prioritization of containment of antimicrobial resistance have created a momentum to implement clinical bacteriology in low-resource settings. Successful implementation relies on guidance by a quality management system (QMS). Over the past decade international initiatives were launched towards implementation of QMS in HIV/AIDS, tuberculosis and malaria. To describe the progress towards accreditation of medical laboratories and to identify the challenges and best practices for implementation of QMS in clinical bacteriology in low-resource settings. Published literature, online reports and websites related to the implementation of laboratory QMS, accreditation of medical laboratories and initiatives for containment of antimicrobial resistance. Apart from the limitations of infrastructure, equipment, consumables and staff, QMS are challenged with the complexity of clinical bacteriology and the healthcare context in low-resource settings (small-scale laboratories, attitudes and perception of staff, absence of laboratory information systems). Likewise, most international initiatives addressing laboratory health strengthening have focused on public health and outbreak management rather than on hospital based patient care. Best practices to implement quality-assured clinical bacteriology in low-resource settings include alignment with national regulations and public health reference laboratories, participating in external quality assurance programmes, support from the hospital's management, starting with attainable projects, conducting error review and daily bench-side supervision, looking for locally adapted solutions, stimulating ownership and extending existing training programmes to clinical bacteriology. The implementation of QMS in clinical bacteriology in hospital settings will ultimately boost a culture of quality to all sectors of healthcare in low-resource settings. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Understanding the 'Silver Book' - An important reference for standardised nomenclature in clinical laboratory sciences.

PubMed

Flatman, Robert; Férard, Georges; Dybkaer, René

2017-04-01

Clinical laboratories perform a wide menu of testing (examinations). Successful requesting, examination, and ordering in this environment requires clear standardised nomenclature. The Silver Book (SB) is an IUPAC (International Union of Pure and Applied Chemistry) publication, produced with the support of both IUPAC and the IFCC (International Federation of Clinical Chemistry and Laboratory Medicine), that makes recommendations on logical standardised nomenclature, symbols, properties, and units in many disciplines of the clinical laboratory sciences. These recommendations are founded on and in agreement with the principles and work of the International Organization for Standardization (ISO), Bureau International des Poids et Mesures (BIPM), IUPAC, and the IFCC. Practical applications described are based on those scientific principles. The SB recommendations apply to all types of examination, not only to measurement of quantities but also examination of nominal properties where no magnitude is involved. The SB is applicable not only to clinical chemistry, but to many other clinical laboratory disciplines. For examples, reports regarding haemostasis, toxicology, clinical microbiology, reproduction and fertility, clinical pharmacology, clinical allergology, clinical molecular biology, and clinical immunohaematology have been published by the IUPAC and the IFCC. Peak scientific bodies such as the IUPAC and the IFCC have important roles in the development of sound international standards for nomenclature of examinations. Such standards support safe and effective representation of patient health information, foster portability, and empower future decision support systems. Copyright © 2016. Published by Elsevier B.V.

Model driven development of clinical information sytems using openEHR.

PubMed

Atalag, Koray; Yang, Hong Yul; Tempero, Ewan; Warren, Jim

2011-01-01

openEHR and the recent international standard (ISO 13606) defined a model driven software development methodology for health information systems. However there is little evidence in the literature describing implementation; especially for desktop clinical applications. This paper presents an implementation pathway using .Net/C# technology for Microsoft Windows desktop platforms. An endoscopy reporting application driven by openEHR Archetypes and Templates has been developed. A set of novel GUI directives has been defined and presented which guides the automatic graphical user interface generator to render widgets properly. We also reveal the development steps and important design decisions; from modelling to the final software product. This might provide guidance for other developers and form evidence required for the adoption of these standards for vendors and national programs alike.

42 CFR 493.1453 - Condition: Laboratories performing high complexity testing; clinical consultant.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Condition: Laboratories performing high complexity testing; clinical consultant. 493.1453 Section 493.1453 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY...

78 FR 9699 - Agency Forms Undergoing Paperwork Reduction Act Review

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-11

... Clinical Laboratories: Perception, Practices and Potential for Expanded Utility--NEW--The Office of Surveillance, Epidemiology and Laboratory Services (OSELS), Centers for Disease Control and Prevention (CDC... benefits and burden of performing PT. This information may be helpful to the CDC as the Clinical Laboratory...

Clinical laboratory accreditation in India.

PubMed

Handoo, Anil; Sood, Swaroop Krishan

2012-06-01

Test results from clinical laboratories must ensure accuracy, as these are crucial in several areas of health care. It is necessary that the laboratory implements quality assurance to achieve this goal. The implementation of quality should be audited by independent bodies,referred to as accreditation bodies. Accreditation is a third-party attestation by an authoritative body, which certifies that the applicant laboratory meets quality requirements of accreditation body and has demonstrated its competence to carry out specific tasks. Although in most of the countries,accreditation is mandatory, in India it is voluntary. The quality requirements are described in standards developed by many accreditation organizations. The internationally acceptable standard for clinical laboratories is ISO15189, which is based on ISO/IEC standard 17025. The accreditation body in India is the National Accreditation Board for Testing and Calibration Laboratories, which has signed Mutual Recognition Agreement with the regional cooperation the Asia Pacific Laboratory Accreditation Cooperation and with the apex cooperation the International Laboratory Accreditation Cooperation.

Impact of an Electronic Health Record-Integrated Personal Health Record on Patient Participation in Health Care: Development and Randomized Controlled Trial of MyHealthKeeper.

PubMed

Ryu, Borim; Kim, Nari; Heo, Eunyoung; Yoo, Sooyoung; Lee, Keehyuck; Hwang, Hee; Kim, Jeong-Whun; Kim, Yoojung; Lee, Joongseek; Jung, Se Young

2017-12-07

Personal health record (PHR)-based health care management systems can improve patient engagement and data-driven medical diagnosis in a clinical setting. The purpose of this study was (1) to demonstrate the development of an electronic health record (EHR)-tethered PHR app named MyHealthKeeper, which can retrieve data from a wearable device and deliver these data to a hospital EHR system, and (2) to study the effectiveness of a PHR data-driven clinical intervention with clinical trial results. To improve the conventional EHR-tethered PHR, we ascertained clinicians' unmet needs regarding PHR functionality and the data frequently used in the field through a cocreation workshop. We incorporated the requirements into the system design and architecture of the MyHealthKeeper PHR module. We constructed the app and validated the effectiveness of the PHR module by conducting a 4-week clinical trial. We used a commercially available activity tracker (Misfit) to collect individual physical activity data, and developed the MyHealthKeeper mobile phone app to record participants' patterns of daily food intake and activity logs. We randomly assigned 80 participants to either the PHR-based intervention group (n=51) or the control group (n=29). All of the study participants completed a paper-based survey, a laboratory test, a physical examination, and an opinion interview. During the 4-week study period, we collected health-related mobile data, and study participants visited the outpatient clinic twice and received PHR-based clinical diagnosis and recommendations. A total of 68 participants (44 in the intervention group and 24 in the control group) completed the study. The PHR intervention group showed significantly higher weight loss than the control group (mean 1.4 kg, 95% CI 0.9-1.9; P<.001) at the final week (week 4). In addition, triglyceride levels were significantly lower by the end of the study period (mean 2.59 mmol/L, 95% CI 17.6-75.8; P=.002). We developed an innovative EHR-tethered PHR system that allowed clinicians and patients to share lifelog data. This study shows the effectiveness of a patient-managed and clinician-guided health tracker system and its potential to improve patient clinical profiles. ClinicalTrials.gov NCT03200119; https://clinicaltrials.gov/ct2/show/NCT03200119 (Archived by WebCite at http://www.webcitation.org/6v01HaCdd). ©Borim Ryu, Nari Kim, Eunyoung Heo, Sooyoung Yoo, Keehyuck Lee, Hee Hwang, Jeong-Whun Kim, Yoojung Kim, Joongseek Lee, Se Young Jung. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 07.12.2017.

Laboratory observation of resistive electron tearing in a two-fluid reconnecting current sheet

DOE PAGES

Jara-Almonte, Jonathan; Ji, Hantao; Yamada, Masaaki; ...

2016-08-25

The spontaneous formation of plasmoids via the resistive electron tearing of a reconnecting current sheet is observed in the laboratory. These experiments are performed during driven, antiparallel reconnection in the two-fluid regime within the Magnetic Reconnection Experiment. It is found that plasmoids are present even at a very low Lundquist number, and the number of plasmoids scales with both the current sheet aspect ratio and the Lundquist number. Furthermore, the reconnection electric field increases when plasmoids are formed, leading to an enhanced reconnection rate.

Treatment of femoro-popliteal lesions with scoring and drug-coated balloon angioplasty: 12-month results of the DCB-Trak registry.

PubMed

Baumhäkel, Magnus; Chkhetia, Shalva; Kindermann, Michael

2018-01-01

Debulking strategies prior to drug-coated balloon (DCB) angioplasty were suggested to improve clinical results in femoro-popliteal lesions. Currently, there are no data regarding plaque modification with a scoring balloon with subsequent DCB-angioplasty. Recently published 6-month results of the DCB-Trak registry in patients treated with scoring-balloon angioplasty and DCB-angioplasty were promising without any safety concerns. Herein, we report the 12-month follow-up data. In a single center registry, 29 consecutive patients with 32 femoro-popliteal lesions were treated with a scoring-balloon (VascuTrak®) and a DCB subsequently. The primary endpoint was the clinically driven target lesion revascularization (TLR). Secondary endpoints were clinically driven target vessel revascularization (TVR), binary restenosis (peak systolic velocity ratio > 2.4), change in Rutherford classification and ankle-brachial-index (ABI). Safety endpoints were major cardiovascular events (cardiovascular death, myocardial infarction, stroke, death) and need for amputation. The procedure was successful in 29 lesions. There were no clinically driven TLRs after 12 months. Two patients required clinically driven TVR and one patient had a binary restenosis. ABI significantly increased after the procedure (0.87±0.24 to 1.04±0.18, P < 0.01) without a relevant change after 6 months (1.01±0.15, P < 0.05) or 12 months (1.01±0.20, P < 0.05). Rutherford classification improved in more than 90% of patients after 6 and 12 months. There was one major cardiovascular event at 6-month follow-up, but no amputations at 6- or 12-month follow-up. Vessel preparation with a scoring-balloon and subsequent DCB-angioplasty was safe and effective in patients with femoro-popliteal lesions. Further multicenter trials have to validate these results.

Data-Driven Identification of Risk Factors of Patient Satisfaction at a Large Urban Academic Medical Center.

PubMed

Li, Li; Lee, Nathan J; Glicksberg, Benjamin S; Radbill, Brian D; Dudley, Joel T

2016-01-01

The Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey is the first publicly reported nationwide survey to evaluate and compare hospitals. Increasing patient satisfaction is an important goal as it aims to achieve a more effective and efficient healthcare delivery system. In this study, we develop and apply an integrative, data-driven approach to identify clinical risk factors that associate with patient satisfaction outcomes. We included 1,771 unique adult patients who completed the HCAHPS survey and were discharged from the inpatient Medicine service from 2010 to 2012. We collected 266 clinical features including patient demographics, lab measurements, medications, disease categories, and procedures. We developed and applied a data-driven approach to identify risk factors that associate with patient satisfaction outcomes. We identify 102 significant risk factors associating with 18 surveyed questions. The most significantly recurrent clinical risk factors were: self-evaluation of health, education level, Asian, White, treatment in BMT oncology division, being prescribed a new medication. Patients who were prescribed pregabalin were less satisfied particularly in relation to communication with nurses and pain management. Explanation of medication usage was associated with communication with nurses (q = 0.001); however, explanation of medication side effects was associated with communication with doctors (q = 0.003). Overall hospital rating was associated with hospital environment, communication with doctors, and communication about medicines. However, patient likelihood to recommend hospital was associated with hospital environment, communication about medicines, pain management, and communication with nurse. Our study identified a number of putatively novel clinical risk factors for patient satisfaction that suggest new opportunities to better understand and manage patient satisfaction. Hospitals can use a data-driven approach to identify clinical risk factors for poor patient satisfaction to support development of specific interventions to improve patients' experience of care.

Epilepsy informatics and an ontology-driven infrastructure for large database research and patient care in epilepsy.

PubMed

Sahoo, Satya S; Zhang, Guo-Qiang; Lhatoo, Samden D

2013-08-01

The epilepsy community increasingly recognizes the need for a modern classification system that can also be easily integrated with effective informatics tools. The 2010 reports by the United States President's Council of Advisors on Science and Technology (PCAST) identified informatics as a critical resource to improve quality of patient care, drive clinical research, and reduce the cost of health services. An effective informatics infrastructure for epilepsy, which is underpinned by a formal knowledge model or ontology, can leverage an ever increasing amount of multimodal data to improve (1) clinical decision support, (2) access to information for patients and their families, (3) easier data sharing, and (4) accelerate secondary use of clinical data. Modeling the recommendations of the International League Against Epilepsy (ILAE) classification system in the form of an epilepsy domain ontology is essential for consistent use of terminology in a variety of applications, including electronic health records systems and clinical applications. In this review, we discuss the data management issues in epilepsy and explore the benefits of an ontology-driven informatics infrastructure and its role in adoption of a "data-driven" paradigm in epilepsy research. Wiley Periodicals, Inc. © 2013 International League Against Epilepsy.

The role of the independent clinical laboratory in new assay development and commercialization.

PubMed

Ellis, David G

2003-01-01

Most would agree that these are exciting times in the field of laboratory medicine. As the body of scientific knowledge expands and research activities, such as those catalyzed by the sequencing of the human genome, bring us closer to the promise of personalized medicine, the clinical laboratory industry will have increasing opportunities to partner with owners of intellectual property to develop and commercialize new diagnostic tests. The large, independent clinical laboratories are particularly well positioned to commercialize important new tests, with their broad market penetration, infrastructure, and the scale to run esoteric tests cost-effectively.

Bioterrorism: a Laboratory Who Does It?

PubMed Central

Lee, Philip A.; Rowlinson, Marie-Claire

2014-01-01

In October 2001, the first disseminated biological warfare attack was perpetrated on American soil. Initially, a few clinical microbiology laboratories were testing specimens from acutely ill patients and also being asked to test nasal swabs from the potentially exposed. Soon after, a significant number of clinical microbiology and public health laboratories received similar requests to test the worried well or evaluate potentially contaminated mail or environmental materials, sometimes from their own break rooms. The role of the clinical and public health microbiology laboratory in response to a select agent event or act of bioterrorism is reviewed. PMID:24648550

Monitoring and reporting of preanalytical errors in laboratory medicine: the UK situation.

PubMed

Cornes, Michael P; Atherton, Jennifer; Pourmahram, Ghazaleh; Borthwick, Hazel; Kyle, Betty; West, Jamie; Costelloe, Seán J

2016-03-01

Most errors in the clinical laboratory occur in the preanalytical phase. This study aimed to comprehensively describe the prevalence and nature of preanalytical quality monitoring practices in UK clinical laboratories. A survey was sent on behalf of the Association for Clinical Biochemistry and Laboratory Medicine Preanalytical Working Group (ACB-WG-PA) to all heads of department of clinical laboratories in the UK. The survey captured data on the analytical platform and Laboratory Information Management System in use; which preanalytical errors were recorded and how they were classified and gauged interest in an external quality assurance scheme for preanalytical errors. Of the 157 laboratories asked to participate, responses were received from 104 (66.2%). Laboratory error rates were recorded per number of specimens, rather than per number of requests in 51% of respondents. Aside from serum indices for haemolysis, icterus and lipaemia, which were measured in 80% of laboratories, the most common errors recorded were booking-in errors (70.1%) and sample mislabelling (56.9%) in laboratories who record preanalytical errors. Of the laboratories surveyed, 95.9% expressed an interest in guidance on recording preanalytical error and 91.8% expressed interest in an external quality assurance scheme. This survey observes a wide variation in the definition, repertoire and collection methods for preanalytical errors in the UK. Data indicate there is a lot of interest in improving preanalytical data collection. The ACB-WG-PA aims to produce guidance and support for laboratories to standardize preanalytical data collection and to help establish and validate an external quality assurance scheme for interlaboratory comparison. © The Author(s) 2015.

Color blindness defect and medical laboratory technologists: unnoticed problems and the care for screening.

PubMed

Dargahi, Hossein; Einollahi, Nahid; Dashti, Nasrin

2010-01-01

Color-blindness is the inability to perceive differences between some color that other people can distinguish. Using a literature search, the results indicate the prevalence of color vision deficiency in the medical profession and its on medical skills. Medical laboratory technicians and technologists employees should also screen for color blindness. This research aimed to study color blindness prevalence among Hospitals' Clinical Laboratories' Employees and Students in Tehran University of Medical Sciences (TUMS). A cross-sectional descriptive and analytical study was conducted among 633 TUMS Clinical Laboratory Sciences' Students and Hospitals' Clinical Laboratories' Employees to detect color-blindness problems by Ishihara Test. The tests were first screened with certain pictures, then compared to the Ishihara criteria to be possible color defective were tested further with other plates to determine color - blindness defects. The data was saved using with SPSS software and analyzed by statistical methods. This is the first study to determine the prevalence of color - blindness in Clinical Laboratory Sciences' Students and Employees. 2.4% of TUMS Medical Laboratory Sciences Students and Hospitals' Clinical Laboratories' Employees are color-blind. There is significant correlation between color-blindness and sex and age. But the results showed that there is not significant correlation between color-blindness defect and exposure to chemical agents, type of job, trauma and surgery history, history of familial defect and race. It would be a wide range of difficulties by color blinded students and employees in their practice of laboratory diagnosis and techniques with a potentially of errors. We suggest color blindness as a medical conditions should restrict employment choices for medical laboratory technicians and technologists job in Iran.

[Study of continuous quality improvement for clinical laboratory processes via the platform of Hospital Group].

PubMed

Song, Wenqi; Shen, Ying; Peng, Xiaoxia; Tian, Jian; Wang, Hui; Xu, Lili; Nie, Xiaolu; Ni, Xin

2015-05-26

The program of continuous quality improvement in clinical laboratory processes for complete blood count (CBC) was launched via the platform of Beijing Children's Hospital Group in order to improve the quality of pediatric clinical laboratories. Fifteen children's hospitals of Beijing Children's Hospital group were investigated using the method of Chinese adapted continuous quality improvement with PDCA (Plan-Do-Check-Action). The questionnaire survey and inter-laboratory comparison was conducted to find the existing problems, to analyze reasons, to set forth quality targets and to put them into practice. Then, targeted training was conducted to 15 children's hospitals and the second questionnaire survey, self examinations by the clinical laboratories was performed. At the same time, the Group's online internal quality control platform was established. Overall effects of the program were evaluated so that lay a foundation for the next stage of PDCA. Both quality of control system documents and CBC internal quality control scheme for all of clinical laboratories were improved through this program. In addition, standardization of performance verification was also improved, especially with the comparable verification rate of precision and internal laboratory results up to 100%. In terms of instrument calibration and mandatory diagnostic rates, only three out of the 15 hospitals (20%) failed to pass muster in 2014 from 46.67% (seven out of the 15 hospitals) in 2013. The abnormal data of intraday precision variance coefficients of the five CBC indicator parameters (WBC, RBC, Hb, Plt and Hct) of all the 15 laboratories accounted for 1.2% (2/165) in 2014, a marked decrease from 9.6% (14/145) in 2013. While the number of the hospitals using only one horizontal quality control object for daily quality control has dropped to three from five. The 15 hospitals organized a total of 263 times of training in 2014 from 101 times in 2013, up 160%. The quality improvement program for the clinical laboratories launched via the Hospital Group platform can promote the joint development of the pediatric clinical laboratory discipline of all the member hospitals with remarkable improvement results, and the experience is recommendable for further rollout.

Measuring Energy Scaling of Laser Driven Magnetic Fields

NASA Astrophysics Data System (ADS)

Williams, Jackson; Goyon, Clement; Mariscal, Derek; Pollock, Brad; Patankar, Siddharth; Moody, John

2016-10-01

Laser-driven magnetic fields are of interest in particle confinement, fast ignition, and ICF platforms as an alternative to pulsed power systems to achieve many times higher fields. A comprehensive model describing the mechanism responsible for creating and maintaining magnetic fields from laser-driven coils has not yet been established. Understanding the scaling of key experimental parameters such as spatial and temporal uniformity and duration are necessary to implement coil targets in practical applications yet these measurements prove difficult due to the highly transient nature of the fields. We report on direct voltage measurements of laser-driven coil targets in which the laser energy spans more than four orders of magnitude. Results suggest that at low energies, laser-driven coils can be modeled as an electric circuit; however, at higher energies plasma effects dominate and a simple circuit treatment is insufficient to describe all observed phenomenon. The favorable scaling with laser power and pulse duration, observed in the present study and others at kilojoule energies, has positive implications for sustained, large magnetic fields for applications on the NIF. This work was performed under the auspices of the U.S. Department of Energy by Lawrence Livermore National Laboratory under Contract DE-AC52-07NA27344.

Oral anatomy laboratory examinations in a physical therapy program.

PubMed

Fabrizio, Philip A

2013-01-01

The process of creating and administering traditional tagged anatomy laboratory examinations is time consuming for instructors and limits laboratory access for students. Depending on class size and the number of class, sections, creating, administering, and breaking down a tagged laboratory examination may involve one to two eight-hour days. During the time that a tagged examination is being created, student productivity may be reduced as the anatomy laboratory is inaccessible to students. Further, the type of questions that can be asked in a tagged laboratory examination may limit student assessment to lower level cognitive abilities and may limit the instructors' ability to assess the students' understanding of anatomical and clinical concepts. Anatomy is a foundational science in the Physical Therapy curriculum and a thorough understanding of anatomy is necessary to progress through the subsequent clinical courses. Physical therapy curricula have evolved to reflect the changing role of physical therapists to primary caregivers by introducing a greater scope of clinical courses earlier in the curriculum. Physical therapy students must have a thorough understanding of clinical anatomy early in the education process. However, traditional anatomy examination methods may not be reflective of the clinical thought processes required of physical therapy students. Traditional laboratory examination methods also reduce student productivity by limiting access during examination set-up and breakdown. To provide a greater complexity of questions and reduced overall laboratory time required for examinations, the Physical Therapy Program at Mercer University has introduced oral laboratory examinations for the gross anatomy course series. © 2012 American Association of Anatomists.

A Chance to Get Ahead: Proficiency Examinations for Clerical Laboratory Personnel. Final Report.

ERIC Educational Resources Information Center

Linehan, Jean D.

Four Proficiency Examinations for Clinical Laboratory Personnel were developed in Clinical Chemistry, Microbiology, Hematology, and Blood Banking. Purpose of project was to enable competent military laboratory technicians who lack credentials to demonstrate their job-related skills and knowledge for civilian positions, and also to help civilians…

A Laboratory Course in Clinical Biochemistry Emphasizing Interest and Relevance

ERIC Educational Resources Information Center

Schwartz, Peter L.

1975-01-01

Ten laboratory experiments are described which are used in a successful clinical biochemistry laboratory course (e.g. blood alcohol, glucose tolerance, plasma triglycerides, coronary risk index, gastric analysis, vitamin C and E). Most of the experiments are performed on the students themselves using simple equipment with emphasis on useful…

The utility of clinical findings to predict laboratory values in hypertensive disorders of pregnancy.

PubMed

So, Jane; Young, Elizabeth; Crnosija, Natalie; Chappelle, Joseph

2016-04-01

Preeclampsia is the 2nd leading cause of maternal mortality in the United States. Women with new-onset or worsening hypertension are commonly evaluated for laboratory abnormalities. We aim to investigate whether demographic and/or clinical findings correlate with abnormal laboratory values. A retrospective chart review of women who presented for evaluation of hypertension in pregnancy during 2010. Demographic information, medical history, symptoms, vital signs, and laboratory results were collected. Bivariate analysis was used to investigate associations between predictors and the outcome. Of the 481 women in the sample, 22 were identified as having abnormal laboratory test results (4.6%). Women who reported right upper quadrant pain or tenderness had significantly increased likelihood of having laboratory abnormalities compared to those without the complaint. Only a small percentage of women evaluated were determined to have abnormal laboratory findings, predominantly among women with severe preeclampsia. Right upper quadrant pain or tenderness was positively correlated with laboratory abnormalities. The restriction of laboratory analysis in women with clinical evidence of severe disease may be warranted - a broader study should, however, first be used to confirm our findings.

Student-Designed Experiments: A Pedagogical Design for Introductory Science Labs

ERIC Educational Resources Information Center

Coker, Jeffrey Scott

2017-01-01

Despite numerous calls for science education to be driven by authentic investigation, many laboratory experiences continue to consist of disconnected weekly units during which students carry out instructions that lead to some predetermined finding. This study developed and evaluated a pedagogical design for introductory biology labs where students…

The Radicalism of the Liberal Arts Tradition.

ERIC Educational Resources Information Center

Lears, Jackson

2003-01-01

Discusses the threat to intellectual freedom in the academy from market-driven managerial influence, the impulse to subject universities to quantitative standards of efficiency and productivity, to turn knowledge into a commodity, and to transform open sites of inquiry into corporate research laboratories and job-training centers. Calls for the…

SOCR: Statistics Online Computational Resource

ERIC Educational Resources Information Center

Dinov, Ivo D.

2006-01-01

The need for hands-on computer laboratory experience in undergraduate and graduate statistics education has been firmly established in the past decade. As a result a number of attempts have been undertaken to develop novel approaches for problem-driven statistical thinking, data analysis and result interpretation. In this paper we describe an…

Regulation of Iron Acquisition Responses in Plant Roots by a Transcription Factor

ERIC Educational Resources Information Center

Bauer, Petra

2016-01-01

The presented research hypothesis-driven laboratory exercise teaches advanced undergraduate students state of the art methods and thinking in an integrated molecular physiology context. Students understand the theoretical background of iron acquisition in the model plant "Arabidopsis thaliana." They design a flowchart summarizing the key…

Bringing the Ocean to the Precollege Classroom through field Investigations at a National Underwater Laboratory

DTIC Science & Technology

1998-09-30

was to use field experiences to 1) enhance educator capability in science content and skills, 2) immerse school systems in an inquiry-driven, active ... learning process, and 3) establish links to real-time scientific information in support of classroom activities. Participants capability in marine

Clinical Laboratory Practice Recommendations for the Use of Cardiac Troponin in Acute Coronary Syndrome: Expert Opinion from the Academy of the American Association for Clinical Chemistry and the Task Force on Clinical Applications of Cardiac Bio-Markers of the International Federation of Clinical Chemistry and Laboratory Medicine.

PubMed

Wu, Alan H B; Christenson, Robert H; Greene, Dina N; Jaffe, Allan S; Kavsak, Peter A; Ordonez-Llanos, Jordi; Apple, Fred S

2018-04-01

This document is an essential companion to the third iteration of the National Academy of Clinical Biochemistry [NACB, 8 now the American Association for Clinical Chemistry (AACC) Academy] Laboratory Medicine Practice Guidelines (LMPG) on cardiac markers. The expert consensus recommendations were drafted in collaboration with the International Federation of Clinical Chemistry and Laboratory Medicine Task Force on Clinical Applications of Bio-Markers (IFCC TF-CB). We determined that there is sufficient clinical guidance on the use of cardiac troponin (cTn) testing from clinical practice groups. Thus, in this expert consensus document, we focused on clinical laboratory practice recommendations for high-sensitivity (hs)-cTn assays. This document utilized the expert opinion class of evidence to focus on the following 10 topics: ( a ) quality control (QC) utilization, ( b ) validation of the lower reportable analytical limits, ( c ) units to be used in reporting measurable concentrations for patients and QC materials, ( d ) 99th percentile sex-specific upper reference limits to define the reference interval; ( e ) criteria required to define hs-cTn assays, ( f ) communication with clinicians and the laboratory's role in educating clinicians regarding the influence of preanalytic and analytic problems that can confound assay results, ( g ) studies on hs-cTn assays and how authors need to document preanalytical and analytical variables, ( h ) harmonizing and standardizing assay results and the role of commutable materials, ( i ) time to reporting of results from sample receipt and sample collection, and ( j ) changes in hs-cTn concentrations over time and the role of both analytical and biological variabilities in interpreting results of serial blood collections. © 2017 American Association for Clinical Chemistry.

78 FR 20112 - Proposed Data Collections Submitted for Public Comment and Recommendations

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-03

...-related information. The respondents would be clinical laboratory supervisors, nurses, and other.../60 300 Supervisors. Influenza Diagnostic Test Practices in Clinical Laboratories. Nurses Survey of... this notice. Proposed Project Survey of Rapid Influenza Diagnostic Test (RIDT) Practices in Clinical...

Laboratory challenges conducting international clinical research in resource-limited settings.

PubMed

Fitzgibbon, Joseph E; Wallis, Carole L

2014-01-01

There are many challenges to performing clinical research in resource-limited settings. Here, we discuss several of the most common laboratory issues that must be addressed. These include issues relating to organization and personnel, laboratory facilities and equipment, standard operating procedures, external quality assurance, shipping, laboratory capacity, and data management. Although much progress has been made, innovative ways of addressing some of these issues are still very much needed.

Effective utilization of clinical laboratories.

PubMed

Murphy, J; Henry, J B

1978-11-01

Effective utilization of clinical laboratories requires that underutilization, overutilization, and malutilization be appreciated and eliminated or reduced. Optimal patient care service, although subjective to a major extent, is reflected in terms of outcome and cost. Increased per diem charges, reduced hospital stay, and increased laboratory workload over the past decade all require each laboratory to examine its internal operations to achieve economy and efficiency as well as maximal effectiveness. Increased research and development, an active managerial role on the part of pathologists, internal self-assessment, and an aggressive response to sophisticated scientific and clinical laboratory data base requirements are not only desirable but essential. The importance of undergraduate and graduate medical education in laboratory medicine to insure understanding as well as effective utilization is stressed. The costs and limitations as well as the accuracy, precision, sensitivity, specificity, and pitfalls of measurements and examinations must also be fully appreciated. Medical malpractice and defensive medicine and the use of critical values, emergency and routine services, and an active clinical role by the pathologist are of the utmost value in assuring effective utilization of the laboratory. A model for the optimal use of the laboratory including economy and efficiency has been achieved in the blood bank in regard to optimal hemotherapy for elective surgery, assuring superior patient care in a cost effective and safe manner.

Has compliance with CLIA requirements really improved quality in US clinical laboratories?

PubMed

Ehrmeyer, Sharon S; Laessig, Ronald H

2004-08-02

The Clinical Laboratory Improvement Amendments of 1988 (CLIA'88) mandate universal requirements for all U.S. clinical laboratory-testing sites. The intent of CLIA'88 is to ensure quality testing through a combination of minimum quality practices that incorporate total quality management concepts. These regulations do not contain established, objective indicators or measures to assess quality. However, there is an implicit assumption that compliance with traditionally accepted good laboratory practices--following manufacturers' directions, routinely analysing quality control materials, applying quality assurance principles, employing and assessing competent testing personnel, and participating in external quality assessment or proficiency testing (PT)--will result in improved test quality. The CLIA'88 regulations do include PT performance standards, which intentionally or unintentionally, define intra-laboratory performance. Passing PT has become a prime motivation for improving laboratory performance; it can also be used as an objective indicator to assess whether compliance to CLIA has improved intra-laboratory quality. Data from 1994 through 2002 indicate that the percentage of laboratories passing PT has increased. In addition to PT performance, subjective indicators of improved quality--frequency of inspection deficiencies, the number of government sanctions for non-compliance, and customer satisfaction--were evaluated. The results from these subjective indicators are more difficult to interpret but also seem to show improved quality in US clinical laboratories eleven years post-CLIA'88.

Implementation of a successful on-call system in clinical chemistry.

PubMed

Hobbs, G A; Jortani, S A; Valdes, R

1997-11-01

Successful practice of clinical pathology depends on a wide variety of laboratory, clinical, and managerial decisions. The skills needed to make these decisions can most effectively be learned by residents and fellows in pathology using a service-oriented on-call approach. We report our experience implementing an on-call system in the clinical chemistry laboratory at the University of Louisville Hospital (Ky). We detail the guidelines used to establish this system and the elements required for its successful implementation. The system emphasizes a laboratory-initiated approach to linking laboratory results to patient care. From inception of the program during late 1990 through 1995, the number of beeper calls (including clinician contacts) steadily increased and is currently 8 to 20 per week. The on-call system is active 24 hours per day, 7 days per week, thus representing activity on all three laboratory shifts. Types of responses were separated into administrative (12%), analytical (42%), clinical (63%), quality control or quality assurance (12%), and consultation (13%) categories. We also present 6 case reports as examples demonstrating multiple elements in these categories. In 23% of the calls, clinician contact was required and achieved by the fellow or resident on call for the laboratory. The on-call reports are documented and presented informally at weekly on-call report sessions. Emphasis is placed on learning and refinement of investigative skills needed to function as an effective laboratory director. Educational emphasis for the medical staff is in establishing awareness of the presence of the laboratory as an important interactive component of patient care. In addition, we found this program to be beneficial to the hospital and to the department of pathology in fulfilling its clinical service and teaching missions. Our experience may be helpful to other institutions establishing such a program.

Model‐Based Approach to Predict Adherence to Protocol During Antiobesity Trials

PubMed Central

Sharma, Vishnu D.; Combes, François P.; Vakilynejad, Majid; Lahu, Gezim; Lesko, Lawrence J.

2017-01-01

Abstract Development of antiobesity drugs is continuously challenged by high dropout rates during clinical trials. The objective was to develop a population pharmacodynamic model that describes the temporal changes in body weight, considering disease progression, lifestyle intervention, and drug effects. Markov modeling (MM) was applied for quantification and characterization of responder and nonresponder as key drivers of dropout rates, to ultimately support the clinical trial simulations and the outcome in terms of trial adherence. Subjects (n = 4591) from 6 Contrave® trials were included in this analysis. An indirect‐response model developed by van Wart et al was used as a starting point. Inclusion of drug effect was dose driven using a population dose‐ and time‐dependent pharmacodynamic (DTPD) model. Additionally, a population‐pharmacokinetic parameter‐ and data (PPPD)‐driven model was developed using the final DTPD model structure and final parameter estimates from a previously developed population pharmacokinetic model based on available Contrave® pharmacokinetic concentrations. Last, MM was developed to predict transition rate probabilities among responder, nonresponder, and dropout states driven by the pharmacodynamic effect resulting from the DTPD or PPPD model. Covariates included in the models and parameters were diabetes mellitus and race. The linked DTPD‐MM and PPPD‐MM was able to predict transition rates among responder, nonresponder, and dropout states well. The analysis concluded that body‐weight change is an important factor influencing dropout rates, and the MM depicted that overall a DTPD model‐driven approach provides a reasonable prediction of clinical trial outcome probabilities similar to a pharmacokinetic‐driven approach. PMID:28858397

Clostridium botulinum and the clinical laboratorian: a detailed review of botulism, including biological warfare ramifications of botulinum toxin.

PubMed

Caya, James G; Agni, Rashmi; Miller, Joan E

2004-06-01

This review article is designed to thoroughly familiarize all health care professionals with the history, classification, epidemiology, clinical characteristics, differential diagnosis, diagnostic evaluation (including laboratory-based testing), treatment, and prognosis of botulism. It is especially targeted toward clinical laboratorians and includes a detailed enumeration of the important clinical laboratory contributions to the diagnosis, treatment, and monitoring of patients with botulism. Finally, the bioterrorism potential for botulism is discussed, with an emphasis on the clinical laboratory ramifications of this possibility. Included medical periodicals and textbooks accessioned from computerized and manual medical literature searches. More than 1000 medical works published from the 1800s through 2003 were retrieved and reviewed in this process. Pertinent data are presented in textual and tabular formats, the latter including 6 tables presenting detailed information regarding the clinical parameters, differential diagnosis, diagnostic studies, laboratory testing, and therapeutic approaches to botulism. Because botulism is such a rare disease, a keen awareness of its manifestations and prompt diagnosis are absolutely crucial for its successful treatment. The bioterrorism potential of botulism adds further urgency to the need for all health care professionals to be familiar with this disease, its proper evaluation, and timely treatment; the need for such urgency clearly includes the clinical laboratory.

Nomenclature and basic concepts in automation in the clinical laboratory setting: a practical glossary.

PubMed

Evangelopoulos, Angelos A; Dalamaga, Maria; Panoutsopoulos, Konstantinos; Dima, Kleanthi

2013-01-01

In the early 80s, the word automation was used in the clinical laboratory setting referring only to analyzers. But in late 80s and afterwards, automation found its way into all aspects of the diagnostic process, embracing not only the analytical but also the pre- and post-analytical phase. While laboratories in the eastern world, mainly Japan, paved the way for laboratory automation, US and European laboratories soon realized the benefits and were quick to follow. Clearly, automation and robotics will be a key survival tool in a very competitive and cost-concious healthcare market. What sets automation technology apart from so many other efficiency solutions are the dramatic savings that it brings to the clinical laboratory. Further standardization will assure the success of this revolutionary new technology. One of the main difficulties laboratory managers and personnel must deal with when studying solutions to reengineer a laboratory is familiarizing themselves with the multidisciplinary and technical terminology of this new and exciting field. The present review/glossary aims at giving an overview of the most frequently used terms within the scope of laboratory automation and to put laboratory automation on a sounder linguistic basis.

Clinical chemistry through Clinical Chemistry: a journal timeline.

PubMed

Rej, Robert

2004-12-01

The establishment of the modern discipline of clinical chemistry was concurrent with the foundation of the journal Clinical Chemistry and that of the American Association for Clinical Chemistry in the late 1940s and early 1950s. To mark the 50th volume of this Journal, I chronicle and highlight scientific milestones, and those within the discipline, as documented in the pages of Clinical Chemistry. Amazing progress has been made in the field of laboratory diagnostics over these five decades, in many cases paralleling-as well as being bolstered by-the rapid pace in the development of computer technologies. Specific areas of laboratory medicine particularly well represented in Clinical Chemistry include lipids, endocrinology, protein markers, quality of laboratory measurements, molecular diagnostics, and general advances in methodology and instrumentation.

Correlations of Clinical and Laboratory Measures of Balance in Older Men and Women: The MOBILIZE Boston Study

PubMed Central

Nguyen, Uyen-Sa D.T.; Kiel, Douglas P.; Li, Wenjun; Galica, Andrew M.; Kang, Hyun Gu; Casey, Virginia A.; Hannan, Marian T.

2012-01-01

Objective Impaired balance is associated with falls in older adults. However, there is no accepted gold standard on how balance should be measured. Few studies have examined measures of postural sway and clinical balance concurrently in large samples of community-dwelling older adults. We examined the associations among four types of measures of laboratory- and clinic-based balance in a large population-based cohort of older adults. Methods We evaluated balance measures in the MOBILIZE Boston Study (276 men, 489 women, 64–97 years). Measures included: (1) laboratory-based anteroposterior (AP) path length and average sway speed, mediolateral (ML) average sway and root-mean-square, and area of ellipse postural sway; (2) Short Physical Performance Battery (SPPB); (3) Berg Balance Scale; and (4) one-leg stand. Spearman Rank Correlation Coefficients (r) were assessed among the balance measures. Results Area of ellipse sway was highly correlated with the ML sway measures (r >0.9, p < 0.0001), and sway speed was highly correlated with AP sway (r=0.97, p < 0.0001). The Berg Balance Scale was highly correlated with SPPB (r=0.7, p<0.001), and one-leg stand (r=0.8, p<0.001). Correlations between the laboratory- and clinic-based balance measures were low but statistically significant (0.2 < r < 0.3, p<0.0001). Conclusion Clinic-based balance measures, and laboratory-based measures comparing area of ellipse with ML sways or sway speed with AP sway, are highly correlated. Clinic- with laboratory-based measures are less correlated. As both laboratory- and clinic-based measures inform balance in older adults but are not highly correlated with each other, future work should investigate the differences. PMID:22745045

Multiplexed and Microparticle-based Analyses: Quantitative Tools for the Large-Scale Analysis of Biological Systems

PubMed Central

Nolan, John P.; Mandy, Francis

2008-01-01

While the term flow cytometry refers to the measurement of cells, the approach of making sensitive multiparameter optical measurements in a flowing sample stream is a very general analytical approach. The past few years have seen an explosion in the application of flow cytometry technology for molecular analysis and measurements using micro-particles as solid supports. While microsphere-based molecular analyses using flow cytometry date back three decades, the need for highly parallel quantitative molecular measurements that has arisen from various genomic and proteomic advances has driven the development in particle encoding technology to enable highly multiplexed assays. Multiplexed particle-based immunoassays are now common place, and new assays to study genes, protein function, and molecular assembly. Numerous efforts are underway to extend the multiplexing capabilities of microparticle-based assays through new approaches to particle encoding and analyte reporting. The impact of these developments will be seen in the basic research and clinical laboratories, as well as in drug development. PMID:16604537

Selecting clinical quality indicators for laboratory medicine.

PubMed

Barth, Julian H

2012-05-01

Quality in laboratory medicine is often described as doing the right test at the right time for the right person. Laboratory processes currently operate under the oversight of an accreditation body which gives confidence that the process is good. However, there are aspects of quality that are not measured by these processes. These are largely focused on ensuring that the most clinically appropriate test is performed and interpreted correctly. Clinical quality indicators were selected through a two-phase process. Firstly, a series of focus groups of clinical scientists were held with the aim of developing a list of quality indicators. These were subsequently ranked in order by an expert panel of primary and secondary care physicians. The 10 top indicators included the communication of critical results, comprehensive education to all users and adequate quality assurance for point-of-care testing. Laboratories should ensure their tests are used to national standards, that they have clinical utility, are calibrated to national standards and have long-term stability for chronic disease management. Laboratories should have error logs and demonstrate evidence of measures introduced to reduce chances of similar future errors. Laboratories should make a formal scientific evaluation of analytical quality. This paper describes the process of selection of quality indicators for laboratory medicine that have been validated sequentially by deliverers and users of the service. They now need to be converted into measureable variables related to outcome and validated in practice.

[Strategy Development for International Cooperation in the Clinical Laboratory Field].

PubMed

Kudo, Yoshiko; Osawa, Susumu

2015-10-01

The strategy of international cooperation in the clinical laboratory field was analyzed to improve the quality of intervention by reviewing documents from international organizations and the Japanese government. Based on the world development agenda, the target of action for health has shifted from communicable diseases to non-communicable diseases (NCD). This emphasizes the importance of comprehensive clinical laboratories instead of disease-specific examinations in developing countries. To achieve this goal, the World Health Organization (WHO) has disseminated to the African and Asian regions the Laboratory Quality Management System (LQMS), which is based on the same principles of the International Organization of Standardization (ISO) 15189. To execute this strategy, international experts must have competence in project management, analyze information regarding the target country, and develop a strategy for management of the LQMS with an understanding of the technical aspects of laboratory work. However, there is no appropriate pre- and post-educational system of international health for Japanese international workers. Universities and academic organizations should cooperate with the government to establish a system of education for international workers. Objectives of this education system must include: (1) training for the organization and understanding of global health issues, (2) education of the principles regarding comprehensive management of clinical laboratories, and (3) understanding the LQMS which was employed based on WHO's initiative. Achievement of these objectives will help improve the quality of international cooperation in the clinical laboratory field.

[An ideal of future medical technologist and a relation with clinical laboratory physician].

PubMed

Murase, Mitsuharu

2005-05-01

As most important things one of medical care system reform of Japan, improvement of the medical treatment related of job was taken in. When it is accompanied to "An ideal of future medical technologist and a relation with clinical laboratory physician" from the meaning, it is necessary to just meet it and in needs at first to be clinical, does the basis with EBM early and time. In addition, it promotes the purchase of economic reagent/articles of consumption than it considered a medical care reward mark while taking that effective medical treatment of patient standard is demanded into consideration and introduces a system of ISO15189 of clinical laboratory. It is necessary for the charm that can support education more and research to aim at a certain medical technologist. Therefore it is for medical technologists to contribute to medical treatment while taking cooperation to be a clinical laboratory physician.

Matrix-assisted laser desorption ionization-time of flight mass spectrometry: a fundamental shift in the routine practice of clinical microbiology.

PubMed

Clark, Andrew E; Kaleta, Erin J; Arora, Amit; Wolk, Donna M

2013-07-01

Within the past decade, clinical microbiology laboratories experienced revolutionary changes in the way in which microorganisms are identified, moving away from slow, traditional microbial identification algorithms toward rapid molecular methods and mass spectrometry (MS). Historically, MS was clinically utilized as a high-complexity method adapted for protein-centered analysis of samples in chemistry and hematology laboratories. Today, matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) MS is adapted for use in microbiology laboratories, where it serves as a paradigm-shifting, rapid, and robust method for accurate microbial identification. Multiple instrument platforms, marketed by well-established manufacturers, are beginning to displace automated phenotypic identification instruments and in some cases genetic sequence-based identification practices. This review summarizes the current position of MALDI-TOF MS in clinical research and in diagnostic clinical microbiology laboratories and serves as a primer to examine the "nuts and bolts" of MALDI-TOF MS, highlighting research associated with sample preparation, spectral analysis, and accuracy. Currently available MALDI-TOF MS hardware and software platforms that support the use of MALDI-TOF with direct and precultured specimens and integration of the technology into the laboratory workflow are also discussed. Finally, this review closes with a prospective view of the future of MALDI-TOF MS in the clinical microbiology laboratory to accelerate diagnosis and microbial identification to improve patient care.

Matrix-Assisted Laser Desorption Ionization–Time of Flight Mass Spectrometry: a Fundamental Shift in the Routine Practice of Clinical Microbiology

PubMed Central

Clark, Andrew E.; Kaleta, Erin J.; Arora, Amit

2013-01-01

SUMMARY Within the past decade, clinical microbiology laboratories experienced revolutionary changes in the way in which microorganisms are identified, moving away from slow, traditional microbial identification algorithms toward rapid molecular methods and mass spectrometry (MS). Historically, MS was clinically utilized as a high-complexity method adapted for protein-centered analysis of samples in chemistry and hematology laboratories. Today, matrix-assisted laser desorption ionization–time of flight (MALDI-TOF) MS is adapted for use in microbiology laboratories, where it serves as a paradigm-shifting, rapid, and robust method for accurate microbial identification. Multiple instrument platforms, marketed by well-established manufacturers, are beginning to displace automated phenotypic identification instruments and in some cases genetic sequence-based identification practices. This review summarizes the current position of MALDI-TOF MS in clinical research and in diagnostic clinical microbiology laboratories and serves as a primer to examine the “nuts and bolts” of MALDI-TOF MS, highlighting research associated with sample preparation, spectral analysis, and accuracy. Currently available MALDI-TOF MS hardware and software platforms that support the use of MALDI-TOF with direct and precultured specimens and integration of the technology into the laboratory workflow are also discussed. Finally, this review closes with a prospective view of the future of MALDI-TOF MS in the clinical microbiology laboratory to accelerate diagnosis and microbial identification to improve patient care. PMID:23824373

Changing needs, opportunities and constraints for the 21st century microbiology laboratory.

PubMed

Van Eldere, J

2005-04-01

Clinical microbiologists and microbiology laboratories are experiencing changes due to evolving views on 'healthcare delivery' as an economic activity, due to changes in the medical environment and the demographics of the workforce, and technical evolution. Cost-effectiveness of laboratory procedures has been achieved through consolidation and integration of laboratories. Consolidation offers economy of scale and reduction in numbers of on-site staff, but also leads to separation of microbiologists from their clinical colleagues. Integration puts different laboratory disciplines under a single management, and leads to reorganisation of laboratories along common work-lines. Cost-savings combined with on-site availability of laboratories are achieved at the expense of a reduction in the influence of microbiologists in the daily running of the laboratory. Medically, there is growing emphasis on evidence-based diagnostics. Because of time-delays inherent in culturing, microbiology through rapid testing is mandatory. There is an increasing shortage in Europe and the USA of trained microbiology laboratory technicians and microbiologists. This reinforces the trend towards more automation and integration. Technological advances, particularly in molecular diagnostics, offer the possibility of rapid reporting and improvement of the impact of clinical microbiology on patient management. Molecular tests, however, fit perfectly the concept of an integrated laboratory and may further loosen the link between microbiologist and microbiology tests. The challenge for clinical microbiology will be to use new techniques to improve its cost-effectiveness and impact on infectious disease management. The future organisation of microbiology laboratories must support this but is itself of secondary importance. The training of future microbiologist must prepare them for this changing environment.

Clinical governance: bridging the gap between managerial and clinical approaches to quality of care

PubMed Central

Buetow, S. A.; Roland, M.

1999-01-01

Clinical governance has been introduced as a new approach to quality improvement in the UK national health service. This article maps clinical governance against a discussion of the four main approaches to measuring and improving quality of care: quality assessment, quality assurance, clinical audit, and quality improvement (including continuous quality improvement). Quality assessment underpins each approach. Whereas clinical audit has, in general, been professionally led, managers have driven quality improvement initiatives. Quality assurance approaches have been perceived to be externally driven by managers or to involve professional inspection. It is discussed how clinical governance seeks to bridge these approaches. Clinical governance allows clinicians in the UK to lead a comprehensive strategy to improve quality within provider organisations, although with an expectation of greatly increased external accountability. Clinical governance aims to bring together managerial, organisational, and clinical approaches to improving quality of care. If successful, it will define a new type of professionalism for the next century. Failure by the professions to seize the opportunity is likely to result in increasingly detailed external control of clinical activity in the UK, as has occurred in some other countries. PMID:10847876

Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain: 2-Year Results From the IN.PACT Global Study.

PubMed

Micari, Antonio; Brodmann, Marianne; Keirse, Koen; Peeters, Patrick; Tepe, Gunnar; Frost, Martin; Wang, Hong; Zeller, Thomas

2018-05-28

The IN.PACT Global Study is the largest prospective, multicenter, independently adjudicated trial to evaluate a paclitaxel drug-coated balloon in patients with lifestyle-limiting claudication and/or ischemic rest pain due to atherosclerotic disease of the femoropopliteal artery and includes complex lesions beyond what are typically included in randomized controlled trials. Randomized controlled trials have demonstrated the safety and efficacy of drug-coated balloons for the treatment of Trans-Atlantic Inter-Society Consensus Document II A and B lesions, but there is a need for large-scale prospective studies to evaluate a broader range of lesions. The IN.PACT Global Study enrolled 1,535 subjects, and 1,406 (1,773 lesions) were included in the pre-defined clinical cohort analysis. Freedom from clinically driven target lesion revascularization was evaluated at 24 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from target limb major amputation and clinically driven target vessel revascularization within 24 months. Mean lesion length was 12.1 cm, 35.5% were total occlusions, and 18.0% had in-stent restenosis. Freedom from clinically driven target lesion revascularization at 24 months was 83.3%, the composite safety endpoint was met in 81.7%, the 2-year all-cause mortality rate was 7.0%, and the major target limb amputation rate was 0.7%. Increased lesion length and the presence of de novo in-stent restenosis or coronary artery disease were associated with increased risk for clinically driven target lesion revascularization by 24 months. This real-world study of femoropopliteal artery disease treatment with drug-coated balloons confirmed positive findings reported from more strictly designed randomized controlled trials and showed that outcomes are durable in this population up to 2 years after treatment. (IN.PACT Global Clinical Study; NCT01609296). Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Automation in clinical biochemistry: core, peripheral, STAT, and specialist laboratories in Australia.

PubMed

Streitberg, George S; Angel, Lyndall; Sikaris, Kenneth A; Bwititi, Phillip T

2012-10-01

Pathology has developed substantially since the 1990s with the introduction of total laboratory automation (TLA), in response to workloads and the need to improve quality. TLA has enhanced core laboratories, which evolved from discipline-based laboratories. Work practices have changed, with central reception now loading samples onto the Inlet module of the TLA. It is important to continually appraise technology. This study looked at the impact of technology using a self-administered survey to seniors in clinical biochemistry in NATA GX/GY-classified laboratories in Australia. The responses were yes, no, or not applicable and are expressed as percentages of responses. Some of the questions sourced for descriptive answers. Eighty-one laboratories responded, and the locations were 63%, 33%, and 4% in capital cities, regional cities, and country towns, respectively. Forty-two percent were public and 58% private. Clinical biochemistry was in all core laboratories of various sizes, and most performed up to 20 tests per sample. Thirty percent of the 121 surveyed laboratories had plans to install an automated line. Fifty-eight percent had hematology and biochemistry instrumentations in their peripheral laboratory, and 16% had a STAT laboratory on the same site as the core laboratory. There were varied instruments in specialist laboratories, and analyzers with embedded computers were in all laboratories. Medium and large laboratories had workstations with integrated instruments, and some large laboratories had TLA. Technology evolution and rising demand for pathology services make it imperative for laboratories to embrace such changes and reorganize the laboratories to take into account point-of-care testing and the efficiencies of core laboratories and TLA.

Clinical Laboratory Evaluation of Electronic Cigarettes/Electronic Nicotine Delivery Systems: Methodological Challenges

PubMed Central

Blank, Melissa D.; Breland, Alison B.; Cobb, Caroline O.; Spindle, Tory; Ramôa, Carolina; Eissenberg, Thomas

2017-01-01

Objective Evaluating electronic cigarettes (ECIGs) in the clinical laboratory is critical to understanding their effects. However, laboratory evaluation of ECIGs can be challenging, as they are a novel, varied, and evolving class of products. The objective of this paper is to describe some methodological challenges to the clinical laboratory evaluation of ECIGs. Methods The authors gathered information about challenges involved in the laboratory evaluation of ECIGs. Challenges were categorized and solutions provided when possible. Results Methods used to study combustible cigarettes may need to be adapted to account for ECIG novelty and differences within the class. Challenges to ECIG evaluation can include issues related to 1) identification of ECIG devices and liquids, 2) determination of short -term ECIG abstinence, 3) measurement of use behavior, and 4) assessment of dependence. These challenges are discussed, and some suggestions to inform ECIG evaluation using clinical laboratory methods are provided. Conclusions Awareness of challenges and developing, validating, and reporting methods used to address them aids interpretation of results and replication efforts, thus enhancing the rigor of science used to protect public health through appropriate, empirically-based, ECIG regulation. PMID:28819633

Clinical Laboratory Evaluation of Electronic Cigarettes/Electronic Nicotine Delivery Systems: Methodological Challenges.

PubMed

Blank, Melissa D; Breland, Alison B; Cobb, Caroline O; Spindle, Tory; Ramôa, Carolina; Eissenberg, Thomas

2016-10-01

Evaluating electronic cigarettes (ECIGs) in the clinical laboratory is critical to understanding their effects. However, laboratory evaluation of ECIGs can be challenging, as they are a novel, varied, and evolving class of products. The objective of this paper is to describe some methodological challenges to the clinical laboratory evaluation of ECIGs. The authors gathered information about challenges involved in the laboratory evaluation of ECIGs. Challenges were categorized and solutions provided when possible. Methods used to study combustible cigarettes may need to be adapted to account for ECIG novelty and differences within the class. Challenges to ECIG evaluation can include issues related to 1) identification of ECIG devices and liquids, 2) determination of short -term ECIG abstinence, 3) measurement of use behavior, and 4) assessment of dependence. These challenges are discussed, and some suggestions to inform ECIG evaluation using clinical laboratory methods are provided. Awareness of challenges and developing, validating, and reporting methods used to address them aids interpretation of results and replication efforts, thus enhancing the rigor of science used to protect public health through appropriate, empirically-based, ECIG regulation.

Verification of performance specifications of a molecular test: cystic fibrosis carrier testing using the Luminex liquid bead array.

PubMed

Lacbawan, Felicitas L; Weck, Karen E; Kant, Jeffrey A; Feldman, Gerald L; Schrijver, Iris

2012-01-01

The number of clinical laboratories introducing various molecular tests to their existing test menu is continuously increasing. Prior to offering a US Food and Drug Administration-approved test, it is necessary that performance characteristics of the test, as claimed by the company, are verified before the assay is implemented in a clinical laboratory. To provide an example of the verification of a specific qualitative in vitro diagnostic test: cystic fibrosis carrier testing using the Luminex liquid bead array (Luminex Molecular Diagnostics, Inc, Toronto, Ontario). The approach used by an individual laboratory for verification of a US Food and Drug Administration-approved assay is described. Specific verification data are provided to highlight the stepwise verification approach undertaken by a clinical diagnostic laboratory. Protocols for verification of in vitro diagnostic assays may vary between laboratories. However, all laboratories must verify several specific performance specifications prior to implementation of such assays for clinical use. We provide an example of an approach used for verifying performance of an assay for cystic fibrosis carrier screening.

Impact of Data-driven Respiratory Gating in Clinical PET.

PubMed

Büther, Florian; Vehren, Thomas; Schäfers, Klaus P; Schäfers, Michael

2016-10-01

Purpose To study the feasibility and impact of respiratory gating in positron emission tomographic (PET) imaging in a clinical trial comparing conventional hardware-based gating with a data-driven approach and to describe the distribution of determined parameters. Materials and Methods This prospective study was approved by the ethics committee of the University Hospital of Münster (AZ 2014-217-f-N). Seventy-four patients suspected of having abdominal or thoracic fluorine 18 fluorodeoxyglucose (FDG)-positive lesions underwent clinical whole-body FDG PET/computed tomographic (CT) examinations. Respiratory gating was performed by using a pressure-sensitive belt system (belt gating [BG]) and an automatic data-driven approach (data-driven gating [DDG]). PET images were analyzed for lesion uptake, metabolic volumes, respiratory shifts of lesions, and diagnostic image quality. Results Forty-eight patients had at least one lesion in the field of view, resulting in a total of 164 lesions analyzed (range of number of lesions per patient, one to 13). Both gating methods revealed respiratory shifts of lesions (4.4 mm ± 3.1 for BG vs 4.8 mm ± 3.6 for DDG, P = .76). Increase in uptake of the lesions compared with nongated values did not differ significantly between both methods (maximum standardized uptake value [SUVmax], +7% ± 13 for BG vs +8% ± 16 for DDG, P = .76). Similarly, gating significantly decreased metabolic lesion volumes with both methods (-6% ± 26 for BG vs -7% ± 21 for DDG, P = .44) compared with nongated reconstructions. Blinded reading revealed significant improvements in diagnostic image quality when using gating, without significant differences between the methods (DDG was judged to be inferior to BG in 22 cases, equal in 12 cases, and superior in 15 cases; P = .32). Conclusion Respiratory gating increases diagnostic image quality and uptake values and decreases metabolic volumes compared with nongated acquisitions. Data-driven approaches are clinically applicable alternatives to belt-based methods and might help establishing routine respiratory gating in clinical PET/CT. (©) RSNA, 2016 Online supplemental material is available for this article.

Medical Biochemistry as Subdiscipline of Laboratory Medicine in Serbia.

PubMed

Jovičić, Snežana; Majkić-Singh, Nada

2017-04-01

Medical biochemistry is the usual name for clinical biochemistry or clinical chemistry in Serbia, and medical biochemist is the official name for the clinical chemist (or clinical biochemist). This is the largest sub-discipline of the laboratory medicine in Serbia. It includes all aspects of clinical chemistry, and also laboratory hematology with coagulation, immunology, etc. Medical biochemistry laboratories in Serbia and medical biochemists as a profession are part of Health Care System and their activities are regulated through: the Health Care Law and rules issued by the Chamber of Medical Biochemists of Serbia. The first continuous and organized education for Medical Biochemists (Clinical Chemists) in Serbia dates from 1945, when the Department of Medical Biochemistry was established at the Pharmaceutical Faculty in Belgrade. In 1987 at the same Faculty a five years undergraduate study program was established, educating Medical Biochemists under a special program. Since the academic year 2006/2007 the new five year undergraduate (according to Bologna Declaration) and four-year postgraduate program according to EC4 European Syllabus for Postgraduate Training in Clinical Chemistry and Laboratory Medicine has been established. The Ministry of Education and Ministry of Public Health accredited these programs. There are four requirements for practicing medical biochemistry in the Health Care System: University Diploma of the Faculty of Pharmacy (Study of Medical Biochemistry), successful completion of the professional exam at the Ministry of Health after completion of one additional year of obligatory practical training in the medical biochemistry laboratories, membership in the Serbian Chamber of Medical Biochemists and licence for skilled work issued by the Serbian Chamber of Medical Biochemists. In order to present laboratory medical biochemistry practice in Serbia this paper will be focused on the following: Serbian national legislation, healthcare services organization, sub-disciplines of laboratory medicine and medical biochemistry as the most significant, education in medical biochemistry, conditions for professional practice in medical biochemistry, continuous quality improvement, and accreditation. Serbian healthcare is based on fundamental principles of universal health coverage and solidarity between all citizens.

Third party laboratory data management: Perspective with respect to clinical data management.

PubMed

Johnson, Jasmin; Kanagali, Vishwanath; Prabu, D

2014-01-01

Third party lab vendor provides support for laboratory, biological samples analytics data, collected during the clinical trial. Third party laboratory data is considered to be very significant for the clinical trial data management process. Although outsourcing these services is considered to be advantageous for clinical trials, there are some risks involved. Hence, pharmaceutical companies proactively select, track and evaluate third party vendors on a regular basis before, during and after the completion of the contract. The data manager has a significant role to play in effective management of third party vendor data.

Third party laboratory data management: Perspective with respect to clinical data management

PubMed Central

Johnson, Jasmin; Kanagali, Vishwanath; Prabu, D.

2014-01-01

Third party lab vendor provides support for laboratory, biological samples analytics data, collected during the clinical trial. Third party laboratory data is considered to be very significant for the clinical trial data management process. Although outsourcing these services is considered to be advantageous for clinical trials, there are some risks involved. Hence, pharmaceutical companies proactively select, track and evaluate third party vendors on a regular basis before, during and after the completion of the contract. The data manager has a significant role to play in effective management of third party vendor data. PMID:24551587

Laboratory Observation of High-Mach Number, Laser-Driven Magnetized Collisionless Shocks

NASA Astrophysics Data System (ADS)

Schaeffer, Derek; Fox, Will; Haberberger, Dan; Fiksel, Gennady; Bhattacharjee, Amitava; Barnak, Daniel; Hu, Suxing; Germaschewski, Kai

2017-06-01

Collisionless shocks are common phenomena in space and astrophysical systems, including solar and planetary winds, coronal mass ejections, supernovae remnants, and the jets of active galactic nuclei, and in many the shocks are believed to efficiently accelerate particles to some of the highest observed energies. Only recently, however, have laser and diagnostic capabilities evolved sufficiently to allow the detailed study in the laboratory of the microphysics of collisionless shocks over a large parameter regime. We present the first laboratory generation of high-Mach number magnetized collisionless shocks created through the interaction of an expanding laser-driven plasma with a magnetized ambient plasma. Time-resolved, two-dimensional imaging of plasma density and magnetic fields shows the formation and evolution of a supercritical shock propagating at magnetosonic Mach number Mms≈12. Particle-in-cell simulations constrained by experimental data further detail the shock formation and separate dynamics of the multi-ion-species ambient plasma. The results show that the shocks form on timescales as fast as one gyroperiod, aided by the efficient coupling of energy, and the generation of a magnetic barrier, between the piston and ambient ions. The development of this experimental platform complements present remote sensing and spacecraft observations, and opens the way for controlled laboratory investigations of high-Mach number collisionless shocks, including the mechanisms and efficiency of particle acceleration. The platform is also flexible, allowing us to study shocks in different magnetic field geometries, in different ambient plasma conditions, and in relation to other effects in magnetized, high-Mach number plasmas such as magnetic reconnection or the Weibel instability.

Argument-Driven Inquiry as a Way to Help Undergraduate Students Write to Learn by Learning to Write in Chemistry

NASA Astrophysics Data System (ADS)

Sampson, Victor; Phelps Walker, Joi

2012-07-01

This exploratory study examined how undergraduate students' ability to write in science changed over time as they completed a series of laboratory activities designed using a new instructional model called argument-driven inquiry. The study was conducted in a single section of an undergraduate general chemistry lab course offered at a large two-year community college located in the southeast USA. The intervention took place over a 15-week semester and consisted of six laboratory activities. During each laboratory activity, the undergraduates wrote investigation reports, participated in a double-blind group peer review of the reports, and revised their reports based on the reviews. The reports written during each laboratory activity were used to examine changes in the students' writing skills over time and to identify aspects of scientific writing that were the most difficult for the undergraduates in this context. The reviews produced by the students during each report were used to evaluate how well undergraduates engage in the peer-review process. The results of a quantitative and qualitative analysis of the reports and reviews indicate that the participants made significant improvements in their ability to write in science and were able to evaluate the quality of their peers' writing with a relatively high degree of accuracy, but they also struggled with several aspects of scientific writing. The conclusions and implications of the study include recommendations for helping undergraduate students learn to write by writing to learn in science and new directions for future research.

Metadata-driven Clinical Data Loading into i2b2 for Clinical and Translational Science Institutes.

PubMed

Post, Andrew R; Pai, Akshatha K; Willard, Richard; May, Bradley J; West, Andrew C; Agravat, Sanjay; Granite, Stephen J; Winslow, Raimond L; Stephens, David S

2016-01-01

Clinical and Translational Science Award (CTSA) recipients have a need to create research data marts from their clinical data warehouses, through research data networks and the use of i2b2 and SHRINE technologies. These data marts may have different data requirements and representations, thus necessitating separate extract, transform and load (ETL) processes for populating each mart. Maintaining duplicative procedural logic for each ETL process is onerous. We have created an entirely metadata-driven ETL process that can be customized for different data marts through separate configurations, each stored in an extension of i2b2 's ontology database schema. We extended our previously reported and open source Eureka! Clinical Analytics software with this capability. The same software has created i2b2 data marts for several projects, the largest being the nascent Accrual for Clinical Trials (ACT) network, for which it has loaded over 147 million facts about 1.2 million patients.

Metadata-driven Clinical Data Loading into i2b2 for Clinical and Translational Science Institutes

PubMed Central

Post, Andrew R.; Pai, Akshatha K.; Willard, Richard; May, Bradley J.; West, Andrew C.; Agravat, Sanjay; Granite, Stephen J.; Winslow, Raimond L.; Stephens, David S.

2016-01-01

Clinical and Translational Science Award (CTSA) recipients have a need to create research data marts from their clinical data warehouses, through research data networks and the use of i2b2 and SHRINE technologies. These data marts may have different data requirements and representations, thus necessitating separate extract, transform and load (ETL) processes for populating each mart. Maintaining duplicative procedural logic for each ETL process is onerous. We have created an entirely metadata-driven ETL process that can be customized for different data marts through separate configurations, each stored in an extension of i2b2 ‘s ontology database schema. We extended our previously reported and open source Eureka! Clinical Analytics software with this capability. The same software has created i2b2 data marts for several projects, the largest being the nascent Accrual for Clinical Trials (ACT) network, for which it has loaded over 147 million facts about 1.2 million patients. PMID:27570667

Cyclic fatigue of ProFile rotary instruments after prolonged clinical use.

PubMed

Gambarini, G

2001-07-01

The purpose of the present study was to evaluate resistance to cyclic fatigue of new and used ProFile Ni-Ti rotary instruments. Used instruments were operated in 10 clinical cases using passive instrumentation and a crown-down preparation technique. Cyclic fatigue testing of new and used engine-driven instruments was then performed with a specific device which allowed the instruments to rotate freely inside a stainless steel artificial canal, whilst maintaining conditions close to the clinical situation. Instruments were rotated until fracture occurred and time to fracture was visually recorded with a chronometer. A significant reduction of rotation time to breakage (life span) was noted between new and used instruments. In all sizes new instruments were significantly more resistant than used ones (two-sample t-test, P < 0.01). No instrument underwent intracanal failure during clinical use. Prolonged clinical use of Ni-Ti engine-driven instruments significantly reduced their cyclic fatigue resistance. Nevertheless, each rotary instrument was successfully operated in up to 10 clinical cases without any intracanal failure.

ClinData Express – A Metadata Driven Clinical Research Data Management System for Secondary Use of Clinical Data

PubMed Central

Li, Zuofeng; Wen, Jingran; Zhang, Xiaoyan; Wu, Chunxiao; Li, Zuogao; Liu, Lei

2012-01-01

Aim to ease the secondary use of clinical data in clinical research, we introduce a metadata driven web-based clinical data management system named ClinData Express. ClinData Express is made up of two parts: 1) m-designer, a standalone software for metadata definition; 2) a web based data warehouse system for data management. With ClinData Express, what the researchers need to do is to define the metadata and data model in the m-designer. The web interface for data collection and specific database for data storage will be automatically generated. The standards used in the system and the data export modular make sure of the data reuse. The system has been tested on seven disease-data collection in Chinese and one form from dbGap. The flexibility of system makes its great potential usage in clinical research. The system is available at http://code.google.com/p/clindataexpress. PMID:23304327

Emerging Technologies for the Clinical Microbiology Laboratory

PubMed Central

Buchan, Blake W.

2014-01-01

SUMMARY In this review we examine the literature related to emerging technologies that will help to reshape the clinical microbiology laboratory. These topics include nucleic acid amplification tests such as isothermal and point-of-care molecular diagnostics, multiplexed panels for syndromic diagnosis, digital PCR, next-generation sequencing, and automation of molecular tests. We also review matrix-assisted laser desorption ionization–time of flight (MALDI-TOF) and electrospray ionization (ESI) mass spectrometry methods and their role in identification of microorganisms. Lastly, we review the shift to liquid-based microbiology and the integration of partial and full laboratory automation that are beginning to impact the clinical microbiology laboratory. PMID:25278575

Defining the challenges of the Modern Analytical Laboratory (CPSA USA 2014): the risks and reality of personalized healthcare.

PubMed

Weng, Naidong; Needham, Shane; Lee, Mike

2015-01-01

The 17th Annual Symposium on Clinical and Pharmaceutical Solutions through Analysis (CPSA) 29 September-2 October 2014, was held at the Sheraton Bucks County Hotel, Langhorne, PA, USA. The CPSA USA 2014 brought the various analytical fields defining the challenges of the modern analytical laboratory. Ongoing discussions focused on the future application of bioanalysis and other disciplines to support investigational new drugs (INDs) and new drug application (NDA) submissions, clinical diagnostics and pathology laboratory personnel that support patient sample analysis, and the clinical researchers that provide insights into new biomarkers within the context of the modern laboratory and personalized medicine.

Mumps: a year of enhanced surveillance in Catalonia, Spain.

PubMed

Dominguez, Angela; Oviedo, Manuel; Torner, Nuria; Carmona, Gloria; Costa, Josep; Caylà, Joan; Sala, M Rosa; Barrabeig, Irene; Camps, Neus; Minguell, Sofia; Alvarez, Josep; Godoy, Pere; Jansà, Josep M

2009-05-26

Mumps is a vaccine-preventable disease candidate for elimination. Positive predictive value (PPV) of clinical case definition was assessed. During 2007, 410 suspected cases were reported in Catalonia: 348 fulfilled clinical case definition and 159 were laboratory confirmed. Incidence rate was 4.8 per 100,000 for cases that fulfilled the clinical definition, and 2.2 for laboratory confirmed cases. Global PPV was 44.5%; 38.5% in <15 years and 50% in > or =15 years (p=0.04). Most laboratory confirmed cases (72.3%) received at least one MMR dose. With sustained high MMR coverage, laboratory confirmation is necessary to control the disease and assess vaccine failure.

The lab without walls: a deployable approach to tropical infectious diseases.

PubMed

Inglis, Timothy J J

2013-04-01

The Laboratory Without Walls is a modular field application of molecular biology that provides clinical laboratory support in resource-limited, remote locations. The current repertoire arose from early attempts to deliver clinical pathology and public health investigative services in remote parts of tropical Australia, to address the shortcomings of conventional methods when faced with emerging infectious diseases. Advances in equipment platforms and reagent chemistry have enabling rapid progress, but also ensure the Laboratory Without Walls is subject to continual improvement. Although new molecular biology methods may lead to more easily deployable clinical laboratory capability, logistic and technical governance issues continue to act as important constraints on wider implementation.

[User's requests (from a practitioner's perspective)].

PubMed

Ohnishi, T

1997-08-01

As a practitioner, I have to rely on outside clinical laboratories and affiliated hospitals to perform laboratory tests. In this abstract, I describe specific problems I have encountered with third-party laboratories, and propose solutions for these problems to optimize use of laboratory tests. BLOOD TESTS: The most frequent problem in ordering blood tests is the lack of detailed information regarding sampling conditions. I often have to call laboratories to check whether the sample should be serum or plasma, what volume is needed, whether the sample should be cooled, etc. I propose that clinical laboratories should provide practitioners' manuals that describe specific sampling information. Most laboratories do not keep the data from ultrasonographic tests. The lack of these is most problematic when test results are interpreted differently by laboratories and by practitioners. Retaining the data would also help private laboratories improve the quality of the test by enabling them to compare their interpretations with others'. ANNUAL MEDICAL SCREENING: Even if an abnormal finding is detected at medical screening clinics, the final diagnosis is usually not sent back to the screening facilities. This is highly recommended to establish an official system that mediates the feedback to screening centers. MRI: Due to miscommunication between practitioners and radiologists, the test is sometimes performed inappropriately. A thorough consultation should occur before the test to clarify specific goals for each patient. PATHOLOGICAL TESTS: Interpretation of results is often inconsistent among laboratories. Independent clinical laboratories tend to report results without indicating sample problems, while pathology departments at affiliated hospitals tend to emphasize sample problems instead of diagnosis or suggesting ways to improve sample quality. Mutual communication among laboratories would help standardize the quality of pathological tests.

[Survey results of medical insurance reimbursement system for independent medical laboratories in Korea].

PubMed

Bae, Sook Young; Kwon, Jung Ah; Kim, Jang Su; Yoon, Soo Young; Lee, Chang Kyu; Lee, Kap No; Kim, Dae Won; Min, Won Ki; Cha, Young Joo; Chae, Seok Lae; Hwang, Yoo Sung

2007-04-01

A questionnaire survey was performed to perceive the problem of the current medical insurance reimbursement system for laboratory tests referred to independent medical laboratories; then, we intended to find a way to improve the reimbursement system. Questionnaires were distributed to 220 independent medical laboratories and 700 laboratory physicians from July through October 2005. Frequency analysis was used to analyse the replies from 109 respondents to 25 questionnaire items regarding the current medical insurance reimbursement system for referral tests, problems with the system, and suggestions for the improvement of the system. Among the 109 respondents to this survey, 49 (45.8%) considered the current reimbursement system to be unsatisfactory, while only 16 (15.0%) answered satisfactory. The problem was that the referral clinics-not the laboratories that performed the tests--would first receive their reimbursement for the laboratory tests from Health Insurance Review Agency (HIRA) and then give a portion of the laboratory test fees to the independent medical laboratories after the deduction of administrative fees. They (62.5% of the respondents) would prefer a separated reimbursement system by which the referral clinic-as well as the independent medical laboratory-would receive their reimbursement directly from HIRA through an Electronic Data Interchange (EDI) system. In this new system, 34% of the respondents expected the quality of the laboratory tests to be improved; however, 41.6% answered that the income of the referral clinic is expected to decrease. For the improvement of the medical insurance reimbursement system, the administrative fee for the referral clinic and the test fee for the independent medical laboratory should be reimbursed directly to the respective organizations. These changes could be made possible with the proper analysis of medical costs and the development of an effective EDI reimbursement system.

Laboratory automation in clinical bacteriology: what system to choose?

PubMed

Croxatto, A; Prod'hom, G; Faverjon, F; Rochais, Y; Greub, G

2016-03-01

Automation was introduced many years ago in several diagnostic disciplines such as chemistry, haematology and molecular biology. The first laboratory automation system for clinical bacteriology was released in 2006, and it rapidly proved its value by increasing productivity, allowing a continuous increase in sample volumes despite limited budgets and personnel shortages. Today, two major manufacturers, BD Kiestra and Copan, are commercializing partial or complete laboratory automation systems for bacteriology. The laboratory automation systems are rapidly evolving to provide improved hardware and software solutions to optimize laboratory efficiency. However, the complex parameters of the laboratory and automation systems must be considered to determine the best system for each given laboratory. We address several topics on laboratory automation that may help clinical bacteriologists to understand the particularities and operative modalities of the different systems. We present (a) a comparison of the engineering and technical features of the various elements composing the two different automated systems currently available, (b) the system workflows of partial and complete laboratory automation, which define the basis for laboratory reorganization required to optimize system efficiency, (c) the concept of digital imaging and telebacteriology, (d) the connectivity of laboratory automation to the laboratory information system, (e) the general advantages and disadvantages as well as the expected impacts provided by laboratory automation and (f) the laboratory data required to conduct a workflow assessment to determine the best configuration of an automated system for the laboratory activities and specificities. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

[Building bridges toward the 21st century].

PubMed

Sasaki, M

2000-10-01

Just as Rome was not built in a day, there are few great inventions and discoveries that can be made overnight. There are always historical circumstances behind them. Laboratory Automation is not an exception. With the end of World War II in 1945 as a turning point, a large volume of American medicine was introduced all over Japan, and clinical laboratory testing which was imported at the same time has taken root and matured. As a result, we can now carry out prompt and fully automated laboratory testing second to none at many hospital laboratories. In this paper, I recall the development and summarize the expansion by focusing on clinical laboratory automation as it has developed in the latter half of the 20th century in Japan. I would feel amply rewarded for my efforts if this paper proved helpful to the young generation. The clinical laboratory of the 21st century rests on their shoulders.

Clinical laboratory billing: superfluous requirements without justification?

PubMed

Stadler, Stephen

2004-01-01

Congress occasionally passes new laws that affect how clinical laboratories handle test orders from physicians and, subsequently, process the billing for tests. Once a bill is signed into law, it is forwarded to administrative agencies, which draft regulations and administrative procedures, under which the intentions of Congress are carried out. In the case of laboratory test ordering and billing, the Centers for Medicare and Medicaid Services (CMS) has the greatest influence over how these regulations and procedures are defined. Unfortunately, in many cases, billing rules have been promulgated in ways that create the need for hospitals and commercial laboratories to expend huge sums of money to bill within the confines of the administrative rules; cause clinical laboratories to suffer from omissions and mistakes of other parties who are part of the patient care process but are not accountable for the billing information they provide to laboratories; and, frankly, in some respects, simply defy common sense.

The Individualized Quality Control Plan - Coming Soon to Clinical Microbiology Laboratories Everywhere!

PubMed

Anderson, Nancy

2015-11-15

As of January 1, 2016, microbiology laboratories can choose to adopt a new quality control option, the Individualized Quality Control Plan (IQCP), under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This voluntary approach increases flexibility for meeting regulatory requirements and provides laboratories the opportunity to customize QC for their testing in their unique environments and by their testing personnel. IQCP is an all-inclusive approach to quality based on risk management to address potential errors in the total testing process. It includes three main steps, (1) performing a risk assessment, (2) developing a QC plan, and (3) monitoring the plan through quality assessment. Resources are available from the Centers for Medicare & Medicaid Services, Centers for Disease Control and Prevention, American Society for Microbiology, Clinical and Laboratory Standards Institute, and accrediting organizations, such as the College of American Pathologists and Joint Commission, to assist microbiology laboratories implementing IQCP.

Chronic myelogenous leukemia: laboratory diagnosis and monitoring.

PubMed

Wang, Y L; Bagg, A; Pear, W; Nowell, P C; Hess, J L

2001-10-01

Rapid developments have occurred both in laboratory medicine and in therapeutic interventions for the management of patients with chronic myelogenous leukemia (CML). With a wide array of laboratory tests available, selecting the appropriate test for a specific diagnostic or therapeutic setting has become increasingly difficult. In this review, we first discuss, from the point of view of laboratory medicine, the advantages and disadvantages of several commonly used laboratory assays, including cytogenetics, fluorescence in situ hybridization (FISH), and qualitative and quantitative reverse transcriptase-polymerase chain reaction (RT-PCR). We then discuss, from the point of view of clinical care, the test(s) of choice for the most common clinical scenarios, including diagnosis and monitoring of the therapeutic response and minimal residual disease in patients treated with different therapies. The purpose of this review is to help clinicians and laboratory physicians select appropriate tests for the diagnosis and monitoring of CML, with the ultimate goal of improving the cost-effective usage of clinical laboratories and improving patient care. Copyright 2001 Wiley-Liss, Inc.

Attrition in NRG Oncology's Radiation-Based Clinical Trials.

PubMed

Ulrich, Connie M; Deshmukh, Snehal; Pugh, Stephanie L; Hanlon, Alexandra; Grady, Christine; Watkins Bruner, Deborah; Curran, Walter

2018-05-10

To determine individual, organizational, and protocol-specific factors associated with attrition in NRG Oncology's radiation-based clinical trials. This retrospective analysis included 27,443 patients representing 134 NRG Oncology's radiation-based clinical trials .trials with primary efficacy results published from 1985-2011. Trials were separated on the basis of the primary endpoint (fixed time vs event driven). The cumulative incidence approach was used to estimate time to attrition, and cause-specific Cox proportional hazards models were used to assess factors associated with attrition. Most patients (69%) were enrolled in an event-driven trial (n = 18,809), while 31% were enrolled in a fixed-time trial (n = 8634). Median follow-up time for patients enrolled in fixed-time trials was 4.1 months and 37.2 months for patients enrolled in event-driven trials. Fixed time trials with a duration < 6 months had a 5 month attrition rate of 4.3% (95% confidence interval [CI]: 3.4%, 5.5%) and those with a duration ≥ 6 months had a 1 year attrition rate of 1.6% (95% CI: 1.2, 2.1). Event-driven trials had 1- and 5-year attrition rates of 0.5% (95% CI: 0.4%, 0.6%) and 13.6% (95% CI: 13.1%, 14.1%), respectively. Younger age, female gender, and Zubrod performance status >0 were associated with greater attrition as were enrollment by institutions in the West and South regions and participation in fixed-time trials. Attrition in clinical trials can have a negative effect on trial outcomes. Data on factors associated with attrition can help guide the development of strategies to enhance retention. These strategies should focus on patient characteristics associated with attrition in both fixed-time and event-driven trials as well as in differing geographic regions of the country. Copyright © 2018. Published by Elsevier Inc.

Development and Validation of a Clinic-Based Prediction Tool to Identify Female Athletes at High Risk for Anterior Cruciate Ligament Injury

PubMed Central

Myer, Gregory D.; Ford, Kevin R.; Khoury, Jane; Succop, Paul; Hewett, Timothy E.

2012-01-01

Background Prospective measures of high knee abduction moment (KAM) during landing identify female athletes at high risk for anterior cruciate ligament injury. Laboratory-based measurements demonstrate 90% accuracy in prediction of high KAM. Clinic-based prediction algorithms that employ correlates derived from laboratory-based measurements also demonstrate high accuracy for prediction of high KAM mechanics during landing. Hypotheses Clinic-based measures derived from highly predictive laboratory-based models are valid for the accurate prediction of high KAM status, and simultaneous measurements using laboratory-based and clinic-based techniques highly correlate. Study Design Cohort study (diagnosis); Level of evidence, 2. Methods One hundred female athletes (basketball, soccer, volleyball players) were tested using laboratory-based measures to confirm the validity of identified laboratory-based correlate variables to clinic-based measures included in a prediction algorithm to determine high KAM status. To analyze selected clinic-based surrogate predictors, another cohort of 20 female athletes was simultaneously tested with both clinic-based and laboratory-based measures. Results The prediction model (odds ratio: 95% confidence interval), derived from laboratory-based surrogates including (1) knee valgus motion (1.59: 1.17-2.16 cm), (2) knee flexion range of motion (0.94: 0.89°-1.00°), (3) body mass (0.98: 0.94-1.03 kg), (4) tibia length (1.55: 1.20-2.07 cm), and (5) quadriceps-to-hamstrings ratio (1.70: 0.48%-6.0%), predicted high KAM status with 84% sensitivity and 67% specificity (P < .001). Clinic-based techniques that used a calibrated physician’s scale, a standard measuring tape, standard camcorder, ImageJ software, and an isokinetic dynamometer showed high correlation (knee valgus motion, r = .87; knee flexion range of motion, r = .95; and tibia length, r = .98) to simultaneous laboratory-based measurements. Body mass and quadriceps-to-hamstrings ratio were included in both methodologies and therefore had r values of 1.0. Conclusion Clinically obtainable measures of increased knee valgus, knee flexion range of motion, body mass, tibia length, and quadriceps-to-hamstrings ratio predict high KAM status in female athletes with high sensitivity and specificity. Female athletes who demonstrate high KAM landing mechanics are at increased risk for anterior cruciate ligament injury and are more likely to benefit from neuromuscular training targeted to this risk factor. Use of the developed clinic-based assessment tool may facilitate high-risk athletes’ entry into appropriate interventions that will have greater potential to reduce their injury risk. PMID:20595554

Theoretical regime diagrams for thermally driven flows in a beta-plane channel. [in atmosphere

NASA Technical Reports Server (NTRS)

Geisler, J. E.; Fowlis, W. W.

1979-01-01

It is noted that thermally driven flows in rotating laboratory containers with cylindrical geometry can be axially symmetric or wavelike depending on the experimental parameters. In anticipation that rotating fluid experiments might soon be done in spherical shell geometry, Barcilon's model has been extended to a beta-plane channel in order to gain a rough understanding of the effects of rotating spherical geometry. An incompressible fluid version of the Charney (1947) model of baroclinic instability, modified to include Ekman pumping at rigid horizontal boundaries is used. With this model, stability boundaries are mapped out for individual zonal wavenumbers in the parameter space used by Barcilon.

An inexpensive modification of the laboratory computer display changes emergency physicians' work habits and perceptions.

PubMed

Marinakis, Harry A; Zwemer, Frank L

2003-02-01

Little is known about how the availability of laboratory data affects emergency physicians' practice habits and satisfaction. We modified our clinical information system to display laboratory test status with continuous updates, similar to an airport arrival display. The objective of this study was to determine whether the laboratory test status display altered emergency physicians' work habits and increased satisfaction compared with the time period before implementation of laboratory test status. A retrospective analysis was performed of emergency physicians' actual use of the clinical information system before and after implementation of the laboratory test status display. Emergency physicians were retrospectively surveyed regarding the effect of laboratory test status display on their practice habits and clinical information system use. Survey responses were matched with actual use of the clinical information system. Data were analyzed by using dependent t tests and Pearson correlation coefficients. The study was conducted at a university hospital. Clinical information system use by 46 emergency physicians was analyzed. Twenty-five surveys were returned (71.4% of available emergency physicians). All emergency physicians perceived fewer clinical information system log ons per day after laboratory test status display. The actual average decrease was 19%. Emergency physicians who reported the greatest decrease in log ons per day tended to have the greatest actual decrease (r =-0.36). There was no significant correlation between actual and perceived total time logged on (r =0.08). In regard to effect on emergency physicians' practice habits, 95% reported increased efficiency, 80% reported improved satisfaction with data access, and 65% reported improved communication with patients. An inexpensive computer modification, laboratory test status display, significantly increased subjective efficiency, changed work habits, and improved satisfaction regarding data access and patient communication among emergency physicians. Knowledge of the test queue changed emergency physician behavior and improved satisfaction.

[The analytical reliability of clinical laboratory information and role of the standards in its support].

PubMed

Men'shikov, V V

2012-12-01

The article deals with the factors impacting the reliability of clinical laboratory information. The differences of qualities of laboratory analysis tools produced by various manufacturers are discussed. These characteristics are the causes of discrepancy of the results of laboratory analyses of the same analite. The role of the reference system in supporting the comparability of laboratory analysis results is demonstrated. The project of national standard is presented to regulate the requirements to standards and calibrators for analysis of qualitative and non-metrical characteristics of components of biomaterials.

Data-driven risk identification in phase III clinical trials using central statistical monitoring.

PubMed

Timmermans, Catherine; Venet, David; Burzykowski, Tomasz

2016-02-01

Our interest lies in quality control for clinical trials, in the context of risk-based monitoring (RBM). We specifically study the use of central statistical monitoring (CSM) to support RBM. Under an RBM paradigm, we claim that CSM has a key role to play in identifying the "risks to the most critical data elements and processes" that will drive targeted oversight. In order to support this claim, we first see how to characterize the risks that may affect clinical trials. We then discuss how CSM can be understood as a tool for providing a set of data-driven key risk indicators (KRIs), which help to organize adaptive targeted monitoring. Several case studies are provided where issues in a clinical trial have been identified thanks to targeted investigation after the identification of a risk using CSM. Using CSM to build data-driven KRIs helps to identify different kinds of issues in clinical trials. This ability is directly linked with the exhaustiveness of the CSM approach and its flexibility in the definition of the risks that are searched for when identifying the KRIs. In practice, a CSM assessment of the clinical database seems essential to ensure data quality. The atypical data patterns found in some centers and variables are seen as KRIs under a RBM approach. Targeted monitoring or data management queries can be used to confirm whether the KRIs point to an actual issue or not.

Canadian Open Genetics Repository (COGR): a unified clinical genomics database as a community resource for standardising and sharing genetic interpretations.

PubMed

Lerner-Ellis, Jordan; Wang, Marina; White, Shana; Lebo, Matthew S

2015-07-01

The Canadian Open Genetics Repository is a collaborative effort for the collection, storage, sharing and robust analysis of variants reported by medical diagnostics laboratories across Canada. As clinical laboratories adopt modern genomics technologies, the need for this type of collaborative framework is increasingly important. A survey to assess existing protocols for variant classification and reporting was delivered to clinical genetics laboratories across Canada. Based on feedback from this survey, a variant assessment tool was made available to all laboratories. Each participating laboratory was provided with an instance of GeneInsight, a software featuring versioning and approval processes for variant assessments and interpretations and allowing for variant data to be shared between instances. Guidelines were established for sharing data among clinical laboratories and in the final outreach phase, data will be made readily available to patient advocacy groups for general use. The survey demonstrated the need for improved standardisation and data sharing across the country. A variant assessment template was made available to the community to aid with standardisation. Instances of the GeneInsight tool were provided to clinical diagnostic laboratories across Canada for the purpose of uploading, transferring, accessing and sharing variant data. As an ongoing endeavour and a permanent resource, the Canadian Open Genetics Repository aims to serve as a focal point for the collaboration of Canadian laboratories with other countries in the development of tools that take full advantage of laboratory data in diagnosing, managing and treating genetic diseases. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Speech processing asymmetry revealed by dichotic listening and functional brain imaging.

PubMed

Hugdahl, Kenneth; Westerhausen, René

2016-12-01

In this article, we review research in our laboratory from the last 25 to 30 years on the neuronal basis for laterality of speech perception focusing on the upper, posterior parts of the temporal lobes, and its functional and structural connections to other brain regions. We review both behavioral and brain imaging data, with a focus on dichotic listening experiments, and using a variety of imaging modalities. The data have come in most parts from healthy individuals and from studies on normally functioning brain, although we also review a few selected clinical examples. We first review and discuss the structural model for the explanation of the right-ear advantage (REA) and left hemisphere asymmetry for auditory language processing. A common theme across many studies have been our interest in the interaction between bottom-up, stimulus-driven, and top-down, instruction-driven, aspects of hemispheric asymmetry, and how perceptual factors interact with cognitive factors to shape asymmetry of auditory language information processing. In summary, our research have shown laterality for the initial processing of consonant-vowel syllables, first observed as a behavioral REA when subjects are required to report which syllable of a dichotic syllable-pair they perceive. In subsequent work we have corroborated the REA with brain imaging, and have shown that the REA is modulated through both bottom-up manipulations of stimulus properties, like sound intensity, and top-down manipulations of cognitive properties, like attention focus. Copyright © 2015 Elsevier Ltd. All rights reserved.

Epstein–Barr virus-associated lymphoproliferative disease in non-immunocompromised hosts: a status report and summary of an international meeting, 8–9 September 2008

PubMed Central

Cohen, J. I.; Kimura, H.; Nakamura, S.; Ko, Y.-H.; Jaffe, E. S.

2009-01-01

Background: Recently novel Epstein–Barr virus (EBV) lymphoproliferative diseases (LPDs) have been identified in non-immunocompromised hosts, both in Asia and Western countries. These include aggressive T-cell and NK-cell LPDs often subsumed under the heading of chronic active Epstein–Barr virus (CAEBV) infection and EBV-driven B-cell LPDs mainly affecting the elderly. Design: To better define the pathogenesis, classification, and treatment of these disorders, participants from Asia, The Americas, Europe, and Australia presented clinical and experimental data at an international meeting. Results: The term systemic EBV-positive T-cell LPD, as adopted by the WHO classification, is preferred as a pathological classification over CAEBV (the favored clinical term) for those cases that are clonal. The disease has an aggressive clinical course, but may arise in the background of CAEBV. Hydroa vacciniforme (HV) and HV-like lymphoma represent a spectrum of clonal EBV-positive T-cell LPDs, which have a more protracted clinical course; spontaneous regression may occur in adult life. Severe mosquito bite allergy is a related syndrome usually of NK cell origin. Immune senescence in the elderly is associated with both reactive and neoplastic EBV-driven LPDs, including EBV-positive diffuse large B-cell lymphomas. Conclusion: The participants proposed an international consortium to facilitate further clinical and biological studies of novel EBV-driven LPDs. PMID:19515747

Epstein-Barr virus-associated lymphoproliferative disease in non-immunocompromised hosts: a status report and summary of an international meeting, 8-9 September 2008.

PubMed

Cohen, J I; Kimura, H; Nakamura, S; Ko, Y-H; Jaffe, E S

2009-09-01

Recently novel Epstein-Barr virus (EBV) lymphoproliferative diseases (LPDs) have been identified in non-immunocompromised hosts, both in Asia and Western countries. These include aggressive T-cell and NK-cell LPDs often subsumed under the heading of chronic active Epstein-Barr virus (CAEBV) infection and EBV-driven B-cell LPDs mainly affecting the elderly. To better define the pathogenesis, classification, and treatment of these disorders, participants from Asia, The Americas, Europe, and Australia presented clinical and experimental data at an international meeting. The term systemic EBV-positive T-cell LPD, as adopted by the WHO classification, is preferred as a pathological classification over CAEBV (the favored clinical term) for those cases that are clonal. The disease has an aggressive clinical course, but may arise in the background of CAEBV. Hydroa vacciniforme (HV) and HV-like lymphoma represent a spectrum of clonal EBV-positive T-cell LPDs, which have a more protracted clinical course; spontaneous regression may occur in adult life. Severe mosquito bite allergy is a related syndrome usually of NK cell origin. Immune senescence in the elderly is associated with both reactive and neoplastic EBV-driven LPDs, including EBV-positive diffuse large B-cell lymphomas. The participants proposed an international consortium to facilitate further clinical and biological studies of novel EBV-driven LPDs.

A novel quantification-driven proteomic strategy identifies an endogenous peptide of pleiotrophin as a new biomarker of Alzheimer's disease.

PubMed

Skillbäck, Tobias; Mattsson, Niklas; Hansson, Karl; Mirgorodskaya, Ekaterina; Dahlén, Rahil; van der Flier, Wiesje; Scheltens, Philip; Duits, Floor; Hansson, Oskar; Teunissen, Charlotte; Blennow, Kaj; Zetterberg, Henrik; Gobom, Johan

2017-10-17

We present a new, quantification-driven proteomic approach to identifying biomarkers. In contrast to the identification-driven approach, limited in scope to peptides that are identified by database searching in the first step, all MS data are considered to select biomarker candidates. The endopeptidome of cerebrospinal fluid from 40 Alzheimer's disease (AD) patients, 40 subjects with mild cognitive impairment, and 40 controls with subjective cognitive decline was analyzed using multiplex isobaric labeling. Spectral clustering was used to match MS/MS spectra. The top biomarker candidate cluster (215% higher in AD compared to controls, area under ROC curve = 0.96) was identified as a fragment of pleiotrophin located near the protein's C-terminus. Analysis of another cohort (n = 60 over four clinical groups) verified that the biomarker was increased in AD patients while no change in controls, Parkinson's disease or progressive supranuclear palsy was observed. The identification of the novel biomarker pleiotrophin 151-166 demonstrates that our quantification-driven proteomic approach is a promising method for biomarker discovery, which may be universally applicable in clinical proteomics.

Meeting the Curriculum Needs for Different Career Paths in Laboratory Medicine

PubMed Central

Smith, Brian R.

2008-01-01

There are a number of career paths in Laboratory Medicine and several clinical practice models for the discipline. This article summarizes the state of current training at the medical student and residency/post-graduate levels, emphasizing practice in the U.S., and the challenges of education in the discipline to meet the needs of diverse career paths. Data regarding effectiveness of current pedagogical Approaches are discussed along with a brief review of evolving didactic methodologies. The recently published curriculum in Laboratory Medicine (Clinical Pathology) by the Academy of Clinical Laboratory Physicians and Scientists is reviewed, including its major emphases and the importance of competency assessment. Finally, the future of Laboratory Medicine and Pathology and the need to train for that future is expanded upon. PMID:18410745

Point-of-care testing (POCT) and evidence-based laboratory medicine (EBLM) - does it leverage any advantage in clinical decision making?

PubMed

Florkowski, Christopher; Don-Wauchope, Andrew; Gimenez, Nuria; Rodriguez-Capote, Karina; Wils, Julien; Zemlin, Annalise

Point-of-care testing (POCT) is the analysis of patient specimens outside the clinical laboratory, near or at the site of patient care, usually performed by clinical staff without laboratory training, although it also encompasses patient self-monitoring. It is able to provide a rapid result near the patient and which can be acted upon immediately. The key driver is the concept that clinical decision making may be delayed when samples are sent to the clinical laboratory. Balanced against this are considerations of increased costs for purchase and maintenance of equipment, staff training, connectivity to the laboratory information system (LIS), quality control (QC) and external quality assurance (EQA) procedures, all required for accreditation under ISO 22870. The justification for POCT depends upon being able to demonstrate that a more timely result (shorter turnaround times (TATs)) is able to leverage a clinically important advantage in decision making compared with the central laboratory (CL). In the four decades since POCT was adapted for the self-monitoring of blood glucose levels by subjects with diabetes, numerous new POCT methodologies have become available, enabling the clinician to receive results and initiate treatment more rapidly. However, these instruments are often operated by staff not trained in laboratory medicine and hence are prone to errors in the analytical phase (as opposed to laboratory testing where the analytical phase has the least errors). In some environments, particularly remote rural settings, the CL may be at a considerable distance and timely availability of cardiac troponins and other analytes can triage referrals to the main centers, thus avoiding expensive unnecessary patient transportation costs. However, in the Emergency Department, availability of more rapid results with POCT does not always translate into shorter stays due to other barriers to implementation of care. In this review, we apply the principles of evidence-based laboratory medicine (EBLM) looking for high quality systematic reviews and meta-analyses, ideally underpinned by randomized controlled trials (RCTs), looking for evidence of whether POCT confers any advantage in clinical decision making in different scenarios.

A national clinical quality program for Veterans Affairs catheterization laboratories (from the Veterans Affairs clinical assessment, reporting, and tracking program).

PubMed

Maddox, Thomas M; Plomondon, Mary E; Petrich, Megan; Tsai, Thomas T; Gethoffer, Hans; Noonan, Gregory; Gillespie, Brian; Box, Tamara; Fihn, Stephen D; Jesse, Robert L; Rumsfeld, John S

2014-12-01

A "learning health care system", as outlined in a recent Institute of Medicine report, harnesses real-time clinical data to continuously measure and improve clinical care. However, most current efforts to understand and improve the quality of care rely on retrospective chart abstractions complied long after the provision of clinical care. To align more closely with the goals of a learning health care system, we present the novel design and initial results of the Veterans Affairs (VA) Clinical Assessment, Reporting, and Tracking (CART) program-a national clinical quality program for VA cardiac catheterization laboratories that harnesses real-time clinical data to support clinical care and quality-monitoring efforts. Integrated within the VA electronic health record, the CART program uses a specialized software platform to collect real-time patient and procedural data for all VA patients undergoing coronary procedures in VA catheterization laboratories. The program began in 2005 and currently contains data on 434,967 catheterization laboratory procedures, including 272,097 coronary angiograms and 86,481 percutaneous coronary interventions, performed by 801 clinicians on 246,967 patients. We present the initial data from the CART program and describe 3 quality-monitoring programs that use its unique characteristics-procedural and complications feedback to individual labs, coronary device surveillance, and major adverse event peer review. The VA CART program is a novel approach to electronic health record design that supports clinical care, quality, and safety in VA catheterization laboratories. Its approach holds promise in achieving the goals of a learning health care system. Published by Elsevier Inc.

Cognitive load privileges memory-based over data-driven processing, not group-level over person-level processing.

PubMed

Skorich, Daniel P; Mavor, Kenneth I

2013-09-01

In the current paper, we argue that categorization and individuation, as traditionally discussed and as experimentally operationalized, are defined in terms of two confounded underlying dimensions: a person/group dimension and a memory-based/data-driven dimension. In a series of three experiments, we unconfound these dimensions and impose a cognitive load. Across the three experiments, two with laboratory-created targets and one with participants' friends as the target, we demonstrate that cognitive load privileges memory-based over data-driven processing, not group- over person-level processing. We discuss the results in terms of their implications for conceptualizations of the categorization/individuation distinction, for the equivalence of person and group processes, for the ultimate 'purpose' and meaningfulness of group-based perception and, fundamentally, for the process of categorization, broadly defined. © 2012 The British Psychological Society.

Sensor modeling and demonstration of a multi-object spectrometer for performance-driven sensing

NASA Astrophysics Data System (ADS)

Kerekes, John P.; Presnar, Michael D.; Fourspring, Kenneth D.; Ninkov, Zoran; Pogorzala, David R.; Raisanen, Alan D.; Rice, Andrew C.; Vasquez, Juan R.; Patel, Jeffrey P.; MacIntyre, Robert T.; Brown, Scott D.

2009-05-01

A novel multi-object spectrometer (MOS) is being explored for use as an adaptive performance-driven sensor that tracks moving targets. Developed originally for astronomical applications, the instrument utilizes an array of micromirrors to reflect light to a panchromatic imaging array. When an object of interest is detected the individual micromirrors imaging the object are tilted to reflect the light to a spectrometer to collect a full spectrum. This paper will present example sensor performance from empirical data collected in laboratory experiments, as well as our approach in designing optical and radiometric models of the MOS channels and the micromirror array. Simulation of moving vehicles in a highfidelity, hyperspectral scene is used to generate a dynamic video input for the adaptive sensor. Performance-driven algorithms for feature-aided target tracking and modality selection exploit multiple electromagnetic observables to track moving vehicle targets.

Role of large-scale velocity fluctuations in a two-vortex kinematic dynamo.

PubMed

Kaplan, E J; Brown, B P; Rahbarnia, K; Forest, C B

2012-06-01

This paper presents an analysis of the Dudley-James two-vortex flow, which inspired several laboratory-scale liquid-metal experiments, in order to better demonstrate its relation to astrophysical dynamos. A coordinate transformation splits the flow into components that are axisymmetric and nonaxisymmetric relative to the induced magnetic dipole moment. The reformulation gives the flow the same dynamo ingredients as are present in more complicated convection-driven dynamo simulations. These ingredients are currents driven by the mean flow and currents driven by correlations between fluctuations in the flow and fluctuations in the magnetic field. The simple model allows us to isolate the dynamics of the growing eigenvector and trace them back to individual three-wave couplings between the magnetic field and the flow. This simple model demonstrates the necessity of poloidal advection in sustaining the dynamo and points to the effect of large-scale flow fluctuations in exciting a dynamo magnetic field.

Knowledge enabled plan of care and documentation prototype.

PubMed

DaDamio, Rebecca; Gugerty, Brian; Kennedy, Rosemary

2006-01-01

There exist significant challenges in integrating the plan of care into documentation and point of care operational processes. A plan of care is often a static artifact that meets regulatory standards with limited influence on supporting goal-directed care delivery processes. Although this prototype is applicable to many clinical disciplines, we will highlight nursing processes in demonstrating a knowledge-driven computerized solution that fully integrates the plan of care within documentation. The knowledge-driven solution reflects evidenced-based practice; is an effective tool for managing problems, orders/interventions, and the patient's progress towards expected outcomes; meets regulatory standards; and drives quality and process improvement. The knowledge infrastructure consists of fully represented terminology, structured clinical expressions utilizing the controlled terminology and clinical knowledge representing evidence-based practice.

Comparative Evaluation of American Cancer Society and American Lung Association Smoking Cessation Clinics.

ERIC Educational Resources Information Center

Lando, Harry A.; And Others

1990-01-01

Compared the effectiveness of the American Cancer Society's "FreshStart," the American Lung Association's "Freedom from Smoking," and a laboratory smoking cessation clinic. A one-year followup favored the more intensive laboratory and "Freedom from Smoking" clinics over the "FreshStart" method. (FMW)

Psychosocial and individual characteristics and musculoskeletal complaints among clinical laboratory workers.

PubMed

Sadeghian, Farideh; Kasaeian, Amir; Noroozi, Pirasteh; Vatani, Javad; Taiebi, Seiyed Hassan

2014-01-01

Musculoskeletal disorders (MSDs) are an important health problem among healthcare workers, including clinical laboratory ones. The aim of the present study was to investigate the prevalence of MSDs and individual and psychosocial risk factors among clinical laboratory workers. A cross-sectional study was carried out among 156 workers of 30 clinical laboratories in 3 towns of Iran. The Nordic questionnaire with individual and psychosocial risk factors was used to collect data. Multiple logistic regression analysis was performed. The prevalence of reported MSDs among the study population was 72.4% in the past 12 months. The most prevalent MSDs were pain in the lower back and neck; 42.7% and 33.3%, respectively. Significant relations were found between MSDs and age, gender, heavy work at home and job control (p < .05). MSDs among laboratory workers were high and associated with age, gender, heavy work at home and job control. More research into measuring these factors and workplace physical demands is suggested.

Laboratory mechanical parameters of composite resins and their relation to fractures and wear in clinical trials-A systematic review.

PubMed

Heintze, Siegward D; Ilie, Nicoleta; Hickel, Reinhard; Reis, Alessandra; Loguercio, Alessandro; Rousson, Valentin

2017-03-01

To evaluate a range of mechanical parameters of composite resins and compare the data to the frequency of fractures and wear in clinical studies. Based on a search of PubMed and SCOPUS, clinical studies on posterior composite restorations were investigated with regard to bias by two independent reviewers using Cochrane Collaboration's tool for assessing risk of bias in randomized trials. The target variables were chipping and/or fracture, loss of anatomical form (wear) and a combination of both (summary clinical index). These outcomes were modelled by time and material in a linear mixed effect model including random study and experiment effects. The laboratory data from one test institute were used: flexural strength, flexural modulus, compressive strength, and fracture toughness (all after 24-h storage in distilled water). For some materials flexural strength data after aging in water/saliva/ethanol were available. Besides calculating correlations between clinical and laboratory outcomes, we explored whether a model including a laboratory predictor dichotomized at a cut-off value better predicted a clinical outcome than a linear model. A total of 74 clinical experiments from 45 studies were included involving 31 materials for which laboratory data were also available. A weak positive correlation between fracture toughness and clinical fractures was found (Spearman rho=0.34, p=0.11) in addition to a moderate and statistically significant correlation between flexural strength and clinical wear (Spearman rho=0.46, p=0.01). When excluding those studies with "high" risk of bias (n=18), the correlations were generally weaker with no statistically significant correlation. For aging in ethanol, a very strong correlation was found between flexural strength decrease and clinical index, but this finding was based on only 7 materials (Spearman rho=0.96, p=0.0001). Prediction was not consistently improved with cutoff values. Correlations between clinical and laboratory outcomes were moderately positive with few significant results, fracture toughness being correlated with clinical fractures and flexural strength with clinical wear. Whether artificial aging enhances the prognostic value needs further investigations. Copyright © 2016 The Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

WUFI (Wärme and Feuchte Instationär)-Oak Ridge National Laboratory (ORNL)/Fraunhofer IBP

DOE Office of Scientific and Technical Information (OSTI.GOV)

Manfred Kehrer, ORNL

2014-05-20

WUFI - Oak Ridge National Laboratory (ORNL)/Fraunhofer IBP is a menu-driven PC program which allows realistic calculation of the transient coupled one-dimensional heat and moisture transport in multi-layer building components exposed to natural weather. It is based on the newest findings regarding vapor diffusion and liquid transport in building materials and has been validated by detailed comparison with measurements obtained in the laboratory and on outdoor testing fields. Together with Oak Ridge National Laboratory (ORNL) Fraunhofer IBP has developed a special version of WUFI ® for North America. WUFI® ORNL is a functionally limited free version of WUFI® Pro formore » non-commercial purposes. It contains climate data for 62 cities in the USA and Canada which are all available in the free version. http://web.ornl.gov/sci/ees/etsd/btric/wufi/ http://www.WUFI.com/ORNL« less

Laboratory simulation of Hg0 emissions from a snowpack.

PubMed

Dommergue, Aurélien; Bahlmann, Enno; Ebinghaus, Ralf; Ferrari, Christophe; Boutron, Claude

2007-05-01

Snow surfaces play an important role in the biogeochemical cycle of mercury in high-latitude regions. Snowpacks act both as sources and sinks for gaseous compounds. Surprisingly, the roles of each environmental parameter that can govern the air-surface exchange over snow are not well understood owing to the lack of systematic studies. A laboratory system called the laboratory flux measurement system was used to study the emission of gaseous elemental mercury from a natural snowpack under controlled conditions. The first results from three snowpacks originating from alpine, urban and polar areas are presented. Consistent with observations in the field, we were able to reproduce gaseous mercury emissions and showed that they are mainly driven by solar radiation and especially UV-B radiation. From these laboratory experiments, we derived kinetic constants which show that divalent mercury can have a short natural lifetime of about 4-6 h in snow.

Overview of Heavy Ion Fusion Accelerator Research in the U. S.

NASA Astrophysics Data System (ADS)

Friedman, Alex

2002-12-01

This article provides an overview of current U.S. research on accelerators for Heavy Ion Fusion, that is, inertial fusion driven by intense beams of heavy ions with the goal of energy production. The concept, beam requirements, approach, and major issues are introduced. An overview of a number of new experiments is presented. These include: the High Current Experiment now underway at Lawrence Berkeley National Laboratory; studies of advanced injectors (and in particular an approach based on the merging of multiple beamlets), being investigated experimentally at Lawrence Livermore National Laboratory); the Neutralized (chamber) Transport Experiment being assembled at Lawrence Berkeley National Laboratory; and smaller experiments at the University of Maryland and at Princeton Plasma Physics Laboratory. The comprehensive program of beam simulations and theory is outlined. Finally, prospects and plans for further development of this promising approach to fusion energy are discussed.

Magnetic turbulence in a table-top laser-plasma relevant to astrophysical scenarios

NASA Astrophysics Data System (ADS)

Chatterjee, Gourab; Schoeffler, Kevin M.; Kumar Singh, Prashant; Adak, Amitava; Lad, Amit D.; Sengupta, Sudip; Kaw, Predhiman; Silva, Luis O.; Das, Amita; Kumar, G. Ravindra

2017-06-01

Turbulent magnetic fields abound in nature, pervading astrophysical, solar, terrestrial and laboratory plasmas. Understanding the ubiquity of magnetic turbulence and its role in the universe is an outstanding scientific challenge. Here, we report on the transition of magnetic turbulence from an initially electron-driven regime to one dominated by ion-magnetization in a laboratory plasma produced by an intense, table-top laser. Our observations at the magnetized ion scale of the saturated turbulent spectrum bear a striking resemblance with spacecraft measurements of the solar wind magnetic-field spectrum, including the emergence of a spectral kink. Despite originating from diverse energy injection sources (namely, electrons in the laboratory experiment and ion free-energy sources in the solar wind), the turbulent spectra exhibit remarkable parallels. This demonstrates the independence of turbulent spectral properties from the driving source of the turbulence and highlights the potential of small-scale, table-top laboratory experiments for investigating turbulence in astrophysical environments.

A Manpower Study of Technical Personnel in Hospital Clinical Laboratories. Final Report.

ERIC Educational Resources Information Center

Harkness, James P., And Others

As one of the efforts related to closing the gap between the growing demands for clinical laboratory workers and the supply of well-trained workers, the volume and quality of laboratory procedures and the general characteristics of workers in North Carolina hospitals were studied. Approaches to the study included tests on "unknowns" by…

[Hyper-reactive malarial splenomegaly].

PubMed

Maazoun, F; Deschamps, O; Barros-Kogel, E; Ngwem, E; Fauchet, N; Buffet, P; Froissart, A

2015-11-01

Hyper-reactive malarial splenomegaly is a rare and severe form of chronic malaria. This condition is a common cause of splenomegaly in endemic areas. The pathophysiology of hyper-reactive malarial splenomegaly involves an intense immune reaction (predominantly B cell-driven) to repeated/chronic infections with Plasmodium sp. The diagnosis may be difficult, due to a poorly specific clinical presentation (splenomegaly, fatigue, cytopenias), a long delay between residence in a malaria-endemic area and onset of symptoms, and a frequent absence of parasites on conventional thin and thick blood smears. A strongly contributive laboratory parameter is the presence of high levels of total immunoglobulin M. When the diagnostic of hyper-reactive malarial splenomegaly is considered, search for anti-Plasmodium antibodies and Plasmodium nucleic acids (genus and species) by PCR is useful. Diagnosis of hyper-reactive malarial splenomegaly relies on the simultaneous presence of epidemiological, clinical, biological and follow-up findings. Regression of both splenomegaly and hypersplenism following antimalarial therapy allows the differential diagnosis with splenic lymphoma, a common complication of hyper-reactive malarial splenomegaly. Although rare in Western countries, hyper-reactive malarial splenomegaly deserves increased medical awareness to reduce the incidence of incorrect diagnosis, to prevent progression to splenic lymphoma and to avoid splenectomy. Copyright © 2015 Société nationale française de médecine interne (SNFMI). Published by Elsevier SAS. All rights reserved.

Standardization of Negative Controls in Diagnostic Immunohistochemistry: Recommendations From the International Ad Hoc Expert Panel

PubMed Central

Torlakovic, Emina E.; Francis, Glenn; Garratt, John; Gilks, Blake; Hyjek, Elizabeth; Ibrahim, Merdol; Miller, Rodney; Nielsen, Søren; Petcu, Eugen B.; Swanson, Paul E.; Taylor, Clive R.; Vyberg, Mogens

2014-01-01

Standardization of controls, both positive and negative controls, is needed for diagnostic immunohistochemistry (dIHC). The use of IHC-negative controls, irrespective of type, although well established, is not standardized. As such, the relevance and applicability of negative controls continues to challenge both pathologists and laboratory budgets. Despite the clear theoretical notion that appropriate controls serve to demonstrate the sensitivity and specificity of the dIHC test, it remains unclear which types of positive and negative controls are applicable and/or useful in day-to-day clinical practice. There is a perceived need to provide “best practice recommendations” for the use of negative controls. This perception is driven not only by logistics and cost issues, but also by increased pressure for accurate IHC testing, especially when IHC is performed for predictive markers, the number of which is rising as personalized medicine continues to develop. Herein, an international ad hoc expert panel reviews classification of negative controls relevant to clinical practice, proposes standard terminology for negative controls, considers the total evidence of IHC specificity that is available to pathologists, and develops a set of recommendations for the use of negative controls in dIHC based on “fit-for-use” principles. PMID:24714041

A hematology consensus agreement on antifungal strategies for neutropenic patients with hematological malignancies and stem cell transplant recipients. Gruppo Italiano Malattie Ematologiche dell'Adulto, Gruppo Italiano Trapianto di Midollo Osseo, Associazione Italiana Ematologia ed Oncologia Pediatrica, Invasive Fungal Infections Cooperative Group of the European Organization for Research and Treatment of Cancer and Sorveglianza Epidemiologica delle Infezioni Fungine nelle Emopatie Maligne.

PubMed

Girmenia, Corrado; Aversa, Franco; Busca, Alessandro; Candoni, Anna; Cesaro, Simone; Luppi, Mario; Pagano, Livio; Rossi, Giuseppe; Venditti, Adriano; Nosari, Anna Maria

2013-09-01

In the attempt to establish key therapy definitions and provide shared approaches to invasive fungal diseases in neutropenic patients, trials of empiric, preeemptive and targeted antifungal therapy (EAT, PAT and TAT) were reviewed, and a Consensus Development Conference Project was convened. The Expert-Panel concurred that all antifungal treatments, including EAT, should always follow an adequate diagnostic strategy and that the standard definition of PAT may be misleading: being PAT guided by the results of a diagnostic work-up, it should better be termed diagnostic-driven antifungal therapy (DDAT). The Expert-Panel agreed that radiological findings alone are insufficient for the choice of a TAT and that the identification of the etiologic pathogen is needed. The Consensus Agreement proceeded identifying which clinical and microbiological findings were sufficient to start a DDAT and which were not. Finally, an algorithm to rationalize the choice of antifungal drugs on the basis of clinical manifestations, antifungal prophylaxis, instrumental and laboratory findings was drawn up. Copyright © 2012 John Wiley & Sons, Ltd.

JobCenter: an open source, cross-platform, and distributed job queue management system optimized for scalability and versatility

PubMed Central

2012-01-01

Background Laboratories engaged in computational biology or bioinformatics frequently need to run lengthy, multistep, and user-driven computational jobs. Each job can tie up a computer for a few minutes to several days, and many laboratories lack the expertise or resources to build and maintain a dedicated computer cluster. Results JobCenter is a client–server application and framework for job management and distributed job execution. The client and server components are both written in Java and are cross-platform and relatively easy to install. All communication with the server is client-driven, which allows worker nodes to run anywhere (even behind external firewalls or “in the cloud”) and provides inherent load balancing. Adding a worker node to the worker pool is as simple as dropping the JobCenter client files onto any computer and performing basic configuration, which provides tremendous ease-of-use, flexibility, and limitless horizontal scalability. Each worker installation may be independently configured, including the types of jobs it is able to run. Executed jobs may be written in any language and may include multistep workflows. Conclusions JobCenter is a versatile and scalable distributed job management system that allows laboratories to very efficiently distribute all computational work among available resources. JobCenter is freely available at http://code.google.com/p/jobcenter/. PMID:22846423

From X-Rays to MRI: Physics in GE

NASA Astrophysics Data System (ADS)

Schmitt, Roland W.

2004-03-01

The GE Research Laboratory, founded in 1900, became the first laboratory of scientific research in U.S. industry. William Coolidge, a physicist, joined the laboratory in 1905 and produced two advances of immense importance. The first, ductile tungsten, is still the heart of every incandescent light bulb. The second, the "Coolidge" X-Ray tube, remains an essential tool of modern medicine. In the process, Coolidge explored two main approaches of physics in industry. One addresses a commercial problem or opportunity (better light bulbs) and finds interesting physics. The other explores interesting physics (X-rays) and creates a commercial opportunity. This paper addresses the mix of these approaches during GE's years as an "electric" (and therefore physics-based) company. Episodes include the following: the work of Irving Langmuir (1932 Nobel laureate in chemistry, but as much physicist as chemist); the post-World War II "golden age of industrial physics" when the endless frontier offered opportunities from nuclear power to diamond making to superconductivity; the Nobel-prize winning work of Ivar Giaever; and interdisciplinary efforts that enabled GE to become a world business leader in two medical diagnostic technologies it did not invent: computed tomography and magnetic resonance imaging. I will speculate on whether this mix of problem-driven and opportunity-driven effort is as relevant to the 21st century as it was to the 20th.

Predator-driven brain size evolution in natural populations of Trinidadian killifish (Rivulus hartii)

PubMed Central

Walsh, Matthew R.; Broyles, Whitnee; Beston, Shannon M.; Munch, Stephan B.

2016-01-01

Vertebrates exhibit extensive variation in relative brain size. It has long been assumed that this variation is the product of ecologically driven natural selection. Yet, despite more than 100 years of research, the ecological conditions that select for changes in brain size are unclear. Recent laboratory selection experiments showed that selection for larger brains is associated with increased survival in risky environments. Such results lead to the prediction that increased predation should favour increased brain size. Work on natural populations, however, foreshadows the opposite trajectory of evolution; increased predation favours increased boldness, slower learning, and may thereby select for a smaller brain. We tested the influence of predator-induced mortality on brain size evolution by quantifying brain size variation in a Trinidadian killifish, Rivulus hartii, from communities that differ in predation intensity. We observed strong genetic differences in male (but not female) brain size between fish communities; second generation laboratory-reared males from sites with predators exhibited smaller brains than Rivulus from sites in which they are the only fish present. Such trends oppose the results of recent laboratory selection experiments and are not explained by trade-offs with other components of fitness. Our results suggest that increased male brain size is favoured in less risky environments because of the fitness benefits associated with faster rates of learning and problem-solving behaviour. PMID:27412278

Mass Spectrometry in Clinical Laboratory: Applications in Therapeutic Drug Monitoring and Toxicology.

PubMed

Garg, Uttam; Zhang, Yan Victoria

2016-01-01

Mass spectrometry (MS) has been used in research and specialized clinical laboratories for decades as a very powerful technology to identify and quantify compounds. In recent years, application of MS in routine clinical laboratories has increased significantly. This is mainly due to the ability of MS to provide very specific identification, high sensitivity, and simultaneous analysis of multiple analytes (>100). The coupling of tandem mass spectrometry with gas chromatography (GC) or liquid chromatography (LC) has enabled the rapid expansion of this technology. While applications of MS are used in many clinical areas, therapeutic drug monitoring, drugs of abuse, and clinical toxicology are still the primary focuses of the field. It is not uncommon to see mass spectrometry being used in routine clinical practices for those applications.

The International Glossary on Infertility and Fertility Care, 2017†‡§

PubMed Central

Zegers-Hochschild, Fernando; Adamson, G David; Dyer, Silke; Racowsky, Catherine; de Mouzon, Jacques; Sokol, Rebecca; Rienzi, Laura; Sunde, Arne; Schmidt, Lone; Cooke, Ian D; Simpson, Joe Leigh; van der Poel, Sheryl

2017-01-01

Abstract STUDY QUESTION Can a consensus and evidence-driven set of terms and definitions be generated to be used globally in order to ensure consistency when reporting on infertility issues and fertility care interventions, as well as to harmonize communication among the medical and scientific communities, policy-makers, and lay public including individuals and couples experiencing fertility problems? SUMMARY ANSWER A set of 283 consensus-based and evidence-driven terminologies used in infertility and fertility care has been generated through an inclusive consensus-based process with multiple stakeholders. WHAT IS KNOWN ALREADY In 2006 the International Committee for Monitoring Assisted Reproductive Technologies (ICMART) published a first glossary of 53 terms and definitions. In 2009 ICMART together with WHO published a revised version expanded to 87 terms, which defined infertility as a disease of the reproductive system, and increased standardization of fertility treatment terminology. Since 2009, limitations were identified in several areas and enhancements were suggested for the glossary, especially concerning male factor, demography, epidemiology and public health issues. STUDY DESIGN, SIZE, DURATION Twenty-five professionals, from all parts of the world and representing their expertise in a variety of sub-specialties, were organized into five working groups: clinical definitions; outcome measurements; embryology laboratory; clinical and laboratory andrology; and epidemiology and public health. Assessment for revisions, as well as expansion on topics not covered by the previous glossary, were undertaken. A larger group of independent experts and representatives from collaborating organizations further discussed and assisted in refining all terms and definitions. PARTICIPANTS/MATERIALS, SETTING, METHODS Members of the working groups and glossary co-ordinators interacted through electronic mail and face-to-face in international/regional conferences. Two formal meetings were held in Geneva, Switzerland, with a final consensus meeting including independent experts as well as observers and representatives of international/regional scientific and patient organizations. MAIN RESULTS AND THE ROLE OF CHANCE A consensus-based and evidence-driven set of 283 terminologies used in infertility and fertility care was generated to harmonize communication among health professionals and scientists as well as the lay public, patients and policy makers. Definitions such as ‘fertility care’ and ‘fertility awareness’ together with terminologies used in embryology and andrology have been introduced in the glossary for the first time. Furthermore, the definition of ‘infertility’ has been expanded in order to cover a wider spectrum of conditions affecting the capacity of individuals and couples to reproduce. The definition of infertility remains as a disease characterized by the failure to establish a clinical pregnancy; however, it also acknowledges that the failure to become pregnant does not always result from a disease, and therefore introduces the concept of an impairment of function which can lead to a disability. Additionally, subfertility is now redundant, being replaced by the term infertility so as to standardize the definition and avoid confusion. LIMITATIONS, REASONS FOR CAUTION All stakeholders agreed to the vast majority of terminologies included in this glossary. In cases where disagreements were not resolved, the final decision was reached after a vote, defined before the meeting as consensus if passed with 75%. Over the following months, an external expert group, which included representatives from non-governmental organizations, reviewed and provided final feedback on the glossary. WIDER IMPLICATIONS OF THE FINDINGS Some terminologies have different definitions, depending on the area of medicine, for example demographic or clinical as well as geographic differences. These differences were taken into account and this glossary represents a multinational effort to harmonize terminologies that should be used worldwide. STUDY FUNDING/COMPETING INTERESTS None. TRIAL REGISTRATION NUMBER N/A. PMID:29117321

Contribution of new technologies to characterization and prediction of adverse effects.

PubMed

Rouquié, David; Heneweer, Marjoke; Botham, Jane; Ketelslegers, Hans; Markell, Lauren; Pfister, Thomas; Steiling, Winfried; Strauss, Volker; Hennes, Christa

2015-02-01

Identification of the potential hazards of chemicals has traditionally relied on studies in laboratory animals where changes in clinical pathology and histopathology compared to untreated controls defined an adverse effect. In the past decades, increased consistency in the definition of adversity with chemically-induced effects in laboratory animals, as well as in the assessment of human relevance has been reached. More recently, a paradigm shift in toxicity testing has been proposed, mainly driven by concerns over animal welfare but also thanks to the development of new methods. Currently, in vitro approaches, toxicogenomic technologies and computational tools, are available to provide mechanistic insight in toxicological Mode of Action (MOA) of the adverse effects observed in laboratory animals. The vision described as Tox21c (Toxicity Testing in the 21st century) aims at predicting in vivo toxicity using a bottom-up-approach, starting with understanding of MOA based on in vitro data to ultimately predict adverse effects in humans. At present, a practical application of the Tox21c vision is still far away. While moving towards toxicity prediction based on in vitro data, a stepwise reduction of in vivo testing is foreseen by combining in vitro with in vivo tests. Furthermore, newly developed methods will also be increasingly applied, in conjunction with established methods in order to gain trust in these new methods. This confidence is based on a critical scientific prerequisite: the establishment of a causal link between data obtained with new technologies and adverse effects manifested in repeated-dose in vivo toxicity studies. It is proposed to apply the principles described in the WHO/IPCS framework of MOA to obtain this link. Finally, an international database of known MOAs obtained in laboratory animals using data-rich chemicals will facilitate regulatory acceptance and could further help in the validation of the toxicity pathway and adverse outcome pathway concepts.

Resource utilization and cost of influenza requiring hospitalization in Canadian adults: A study from the serious outcomes surveillance network of the Canadian Immunization Research Network.

PubMed

Ng, Carita; Ye, Lingyun; Noorduyn, Stephen G; Hux, Margaret; Thommes, Edward; Goeree, Ron; Ambrose, Ardith; Andrew, Melissa K; Hatchette, Todd; Boivin, Guy; Bowie, William; ElSherif, May; Green, Karen; Johnstone, Jennie; Katz, Kevin; Leblanc, Jason; Loeb, Mark; MacKinnon-Cameron, Donna; McCarthy, Anne; McElhaney, Janet; McGeer, Allison; Poirier, Andre; Powis, Jeff; Richardson, David; Sharma, Rohita; Semret, Makeda; Smith, Stephanie; Smyth, Daniel; Stiver, Grant; Trottier, Sylvie; Valiquette, Louis; Webster, Duncan; McNeil, Shelly A

2018-03-01

Consideration of cost determinants is crucial to inform delivery of public vaccination programs. To estimate the average total cost of laboratory-confirmed influenza requiring hospitalization in Canadians prior to, during, and 30 days following discharge. To analyze effects of patient/disease characteristics, treatment, and regional differences in costs. Study utilized previously recorded clinical characteristics, resource use, and outcomes of laboratory-confirmed influenza patients admitted to hospitals in the Serious Outcomes Surveillance (SOS), Canadian Immunization Research Network (CIRN), from 2010/11 to 2012/13. Unit costs including hospital overheads were linked to inpatient/outpatient resource utilization before and after admissions. Dataset included 2943 adult admissions to 17 SOS Network hospitals and 24 Toronto Invasive Bacterial Disease Network hospitals. Mean age was 69.5 years. Average hospital stay was 10.8 days (95% CI: 10.3, 11.3), general ward stays were 9.4 days (95% CI: 9.0, 9.8), and ICU stays were 9.8 days (95% CI: 8.6, 11.1) for the 14% of patients admitted to the ICU. Average cost per case was $14 612 CAD (95% CI: $13 852, $15 372) including $133 (95% CI: $116, $150) for medical care prior to admission, $14 031 (95% CI: $13 295, $14 768) during initial hospital stay, $447 (95% CI: $271, $624) post-discharge, including readmission within 30 days. The cost of laboratory-confirmed influenza was higher than previous estimates, driven mostly by length of stay and analyzing only laboratory-confirmed influenza cases. The true per-patient cost of influenza-related hospitalization has been underestimated, and prevention programs should be evaluated in this context. © 2017 The Authors. Influenza and Other Respiratory Viruses Published by John Wiley & Sons Ltd.

The Call for Data-Driven Decision Making in the Midwest's Schools: NCREL's Response.

ERIC Educational Resources Information Center

Cromey, Allison; van der Ploeg, Arie; Masini, Blase

This report describes the efforts of the North Central Regional Educational Laboratory (NCREL) during the last several years to respond to direct requests from educational stakeholders to help integrate data into their decision-making processes related to school improvement. In some cases, NCREL cooperated in the development of educational…

Independent Research Projects Using Protein Extraction: Affordable Ways to Inquire, Discover & Publish for Undergraduate Students

ERIC Educational Resources Information Center

Pu, Rongsun

2010-01-01

This article describes how to use protein extraction, quantification, and analysis in the undergraduate teaching laboratory to engage students in inquiry-based, discovery-driven learning. Detailed instructions for obtaining proteins from animal tissues, using BCA assay to quantify the proteins, and data analysis are provided. The experimental…

To Build an Ecosystem: An Introductory Lab for Environmental Science & Biology Students

ERIC Educational Resources Information Center

Hudon, Daniel; Finnerty, John R.

2013-01-01

A hypothesis-driven laboratory is described that introduces students to the complexities of ecosystem function. Students work with live algae, brine shrimp, and sea anemones to test hypotheses regarding the trophic interactions among species, the exchange of nutrients and gases, and the optimal ratio of producers to consumers and predators in…

Found in Translation: What’s going on at the USDA’s Beltsville Bee Research Laboratory

USDA-ARS?s Scientific Manuscript database

Practical research discoveries follow a twisting path. Basic research driven by the human need to understand nature can, often years or even decades later, lead to huge advances that benefit people or the environment. Alternatively, sure-thing tests of a new product, management strategy, or breeding...

Who Owns Educational Theory? Big Data, Algorithms and the Expert Power of Education Data Science

ERIC Educational Resources Information Center

Williamson, Ben

2017-01-01

"Education data science" is an emerging methodological field which possesses the algorithm-driven technologies required to generate insights and knowledge from educational big data. This article consists of an analysis of the Lytics Lab, Stanford University's laboratory for research and development in learning analytics, and the Center…

Teaching Standard Deviation by Building from Student Invention

ERIC Educational Resources Information Center

Day, James; Nakahara, Hiroko; Bonn, Doug

2010-01-01

First-year physics laboratories are often driven by a mix of goals that includes the illustration or discovery of basic physics principles and a myriad of technical skills involving specific equipment, data analysis, and report writing. The sheer number of such goals seems guaranteed to produce cognitive overload, even when highly detailed…

EFFECTIVE REMOVAL OF TCE IN A LABORATORY MODEL OF A PRB CONSTRUCTED WITH PLANT MULCH

EPA Science Inventory

Ground water contaminated with TCE is commonly treated with a permeable reactive barrier (PRB) constructed with zero-valence iron. The cost of iron as the reactive matrix has driven a search for less costly alternatives, and composted plant mulch has been used as an alternative ...

Laboratory plate tectonics: a new experiment.

PubMed

Gans, R F

1976-03-26

A "continent" made of a layer of hexagonally packed black polyethylene spheres floating in clear silicon oil breaks into subcontinents when illuminated by an ordinary incandescent light bulb. This experiment may be a useful model of plate tectonics driven by horizontal temperature gradients. Measurements of the spreading rate are made to establish the feasibility of this model.

A Process Dynamics and Control Experiment for the Undergraduate Laboratory

ERIC Educational Resources Information Center

Spencer, Jordan L.

2009-01-01

This paper describes a process control experiment. The apparatus includes a three-vessel glass flow system with a variable flow configuration, means for feeding dye solution controlled by a stepper-motor driven valve, and a flow spectrophotometer. Students use impulse response data and nonlinear regression to estimate three parameters of a model…

Student-Driven Design of Peptide Mimetics: Microwave-Assisted Synthesis of Peptoid Oligomers

ERIC Educational Resources Information Center

Pohl, Nicola L. B.; Kirshenbaum, Kent; Yoo, Barney; Schulz, Nathan; Zea, Corbin J.; Streff, Jennifer M.; Schwarz, Kimberly L.

2011-01-01

An experiment for the undergraduate organic laboratory is described in which peptide mimetic oligomers called "peptoids" are built stepwise on a solid-phase resin. Students employ two modern strategies to facilitate rapid multistep syntheses: solid-phase techniques to obviate the need for intermediate purifications and microwave irradiation to…

Plasma Instabilities and Transport in the MPD Thruster

DTIC Science & Technology

1993-06-01

driven plasma accelera- tion vesrus current-deiven energy dissipation Part III: anomalous trasnport . In 2 8’A Joint Propulsion Conference, Nashville... trasnport In the March/April Bi- monthly Progress Report of the Electric Propulsion and Plasma Dynamics Laboratory. Technical Report MAE 1776.36, EPPDyL, Princeton Univer- sity, 1992. 0 0

A laboratory investigation of interactions between denitrifying anaerobic methane oxidation (DAMO) and anammox processes in anoxic environments

PubMed Central

Hu, Shihu; Zeng, Raymond J.; Haroon, Mohamed F.; Keller, Jurg; Lant, Paul A.; Tyson, Gene W.; Yuan, Zhiguo

2015-01-01

This study investigates interactions between recently identified denitrifying anaerobic methane oxidation (DAMO) and anaerobic ammonium oxidation (anammox) processes in controlled anoxic laboratory reactors. Two reactors were seeded with the same inocula containing DAMO organisms Candidatus Methanoperedens nitroreducens and Candidatus Methylomirabilis oxyfera, and anammox organism Candidatus Kuenenia stuttgartiensis. Both were fed with ammonium and methane, but one was also fed with nitrate and the other with nitrite, providing anoxic environments with different electron acceptors. After steady state reached in several months, the DAMO process became solely/primarily responsible for nitrate reduction while the anammox process became solely responsible for nitrite reduction in both reactors. 16S rRNA gene amplicon sequencing showed that the nitrate-driven DAMO organism M. nitroreducens dominated both the nitrate-fed (~70%) and the nitrite-fed (~26%) reactors, while the nitrite-driven DAMO organism M. oxyfera disappeared in both communities. The elimination of M. oxyfera from both reactors was likely the results of this organism being outcompeted by anammox bacteria for nitrite. K. stuttgartiensis was detected at relatively low levels (1–3%) in both reactors. PMID:25732131

rf improvements for Spallation Neutron Source H- ion sourcea)

NASA Astrophysics Data System (ADS)

Kang, Y. W.; Fuja, R.; Goulding, R. H.; Hardek, T.; Lee, S.-W.; McCarthy, M. P.; Piller, M. C.; Shin, K.; Stockli, M. P.; Welton, R. F.

2010-02-01

The Spallation Neutron Source at Oak Ridge National Laboratory is ramping up the accelerated proton beam power to 1.4 MW and just reached 1 MW. The rf-driven multicusp ion source that originates from the Lawrence Berkeley National Laboratory has been delivering ˜38 mA H- beam in the linac at 60 Hz, 0.9 ms. To improve availability, a rf-driven external antenna multicusp ion source with a water-cooled ceramic aluminum nitride (AlN) plasma chamber is developed. Computer modeling and simulations have been made to analyze and optimize the rf performance of the new ion source. Operational statistics and test runs with up to 56 mA medium energy beam transport beam current identify the 2 MHz rf system as a limiting factor in the system availability and beam production. Plasma ignition system is under development by using a separate 13 MHz system. To improve the availability of the rf power system with easier maintenance, we tested a 70 kV isolation transformer for the 80 kW, 6% duty cycle 2 MHz amplifier to power the ion source from a grounded solid-state amplifier.

rf improvements for Spallation Neutron Source H- ion source.

PubMed

Kang, Y W; Fuja, R; Goulding, R H; Hardek, T; Lee, S-W; McCarthy, M P; Piller, M C; Shin, K; Stockli, M P; Welton, R F

2010-02-01

The Spallation Neutron Source at Oak Ridge National Laboratory is ramping up the accelerated proton beam power to 1.4 MW and just reached 1 MW. The rf-driven multicusp ion source that originates from the Lawrence Berkeley National Laboratory has been delivering approximately 38 mA H(-) beam in the linac at 60 Hz, 0.9 ms. To improve availability, a rf-driven external antenna multicusp ion source with a water-cooled ceramic aluminum nitride (AlN) plasma chamber is developed. Computer modeling and simulations have been made to analyze and optimize the rf performance of the new ion source. Operational statistics and test runs with up to 56 mA medium energy beam transport beam current identify the 2 MHz rf system as a limiting factor in the system availability and beam production. Plasma ignition system is under development by using a separate 13 MHz system. To improve the availability of the rf power system with easier maintenance, we tested a 70 kV isolation transformer for the 80 kW, 6% duty cycle 2 MHz amplifier to power the ion source from a grounded solid-state amplifier.

Improvement or selection? A longitudinal analysis of students' views about experimental physics in their lab courses

NASA Astrophysics Data System (ADS)

Wilcox, Bethany R.; Lewandowski, H. J.

2017-12-01

Laboratory courses represent a unique and potentially important component of the undergraduate physics curriculum, which can be designed to allow students to authentically engage with the process of experimental physics. Among other possible benefits, participation in these courses throughout the undergraduate physics curriculum presents an opportunity to develop students' understanding of the nature and importance of experimental physics within the discipline as a whole. Here, we present and compare both a longitudinal and pseudolongitudinal analysis of students' responses to a research-based assessment targeting students' views about experimental physics—the Colorado Learning Attitudes about Science Survey for Experimental Physics (E-CLASS)—across multiple, required lab courses at a single institution. We find that, while pseudolongitudinal averages showed increases in students' E-CLASS scores in each consecutive course, analysis of longitudinal data indicates that this increase was not driven by a cumulative impact of laboratory instruction. Rather, the increase was driven by a selection effect in which students who persisted into higher-level lab courses already had more expertlike beliefs, attitudes, and expectations than their peers when they started the lower-level courses.

Biosensor-driven adaptive laboratory evolution of l-valine production in Corynebacterium glutamicum.

PubMed

Mahr, Regina; Gätgens, Cornelia; Gätgens, Jochem; Polen, Tino; Kalinowski, Jörn; Frunzke, Julia

2015-11-01

Adaptive laboratory evolution has proven a valuable strategy for metabolic engineering. Here, we established an experimental evolution approach for improving microbial metabolite production by imposing an artificial selective pressure on the fluorescent output of a biosensor using fluorescence-activated cell sorting. Cells showing the highest fluorescent output were iteratively isolated and (re-)cultivated. The L-valine producer Corynebacterium glutamicum ΔaceE was equipped with an L-valine-responsive sensor based on the transcriptional regulator Lrp of C. glutamicum. Evolved strains featured a significantly higher growth rate, increased L-valine titers (~25%) and a 3-4-fold reduction of by-product formation. Genome sequencing resulted in the identification of a loss-of-function mutation (UreD-E188*) in the gene ureD (urease accessory protein), which was shown to increase L-valine production by up to 100%. Furthermore, decreased L-alanine formation was attributed to a mutation in the global regulator GlxR. These results emphasize biosensor-driven evolution as a straightforward approach to improve growth and productivity of microbial production strains. Copyright © 2015 International Metabolic Engineering Society. Published by Elsevier Inc. All rights reserved.

Building Data-Driven Pathways From Routinely Collected Hospital Data: A Case Study on Prostate Cancer

PubMed Central

Clark, Jeremy; Cooper, Colin S; Mills, Robert; Rayward-Smith, Victor J; de la Iglesia, Beatriz

2015-01-01

Background Routinely collected data in hospitals is complex, typically heterogeneous, and scattered across multiple Hospital Information Systems (HIS). This big data, created as a byproduct of health care activities, has the potential to provide a better understanding of diseases, unearth hidden patterns, and improve services and cost. The extent and uses of such data rely on its quality, which is not consistently checked, nor fully understood. Nevertheless, using routine data for the construction of data-driven clinical pathways, describing processes and trends, is a key topic receiving increasing attention in the literature. Traditional algorithms do not cope well with unstructured processes or data, and do not produce clinically meaningful visualizations. Supporting systems that provide additional information, context, and quality assurance inspection are needed. Objective The objective of the study is to explore how routine hospital data can be used to develop data-driven pathways that describe the journeys that patients take through care, and their potential uses in biomedical research; it proposes a framework for the construction, quality assessment, and visualization of patient pathways for clinical studies and decision support using a case study on prostate cancer. Methods Data pertaining to prostate cancer patients were extracted from a large UK hospital from eight different HIS, validated, and complemented with information from the local cancer registry. Data-driven pathways were built for each of the 1904 patients and an expert knowledge base, containing rules on the prostate cancer biomarker, was used to assess the completeness and utility of the pathways for a specific clinical study. Software components were built to provide meaningful visualizations for the constructed pathways. Results The proposed framework and pathway formalism enable the summarization, visualization, and querying of complex patient-centric clinical information, as well as the computation of quality indicators and dimensions. A novel graphical representation of the pathways allows the synthesis of such information. Conclusions Clinical pathways built from routinely collected hospital data can unearth information about patients and diseases that may otherwise be unavailable or overlooked in hospitals. Data-driven clinical pathways allow for heterogeneous data (ie, semistructured and unstructured data) to be collated over a unified data model and for data quality dimensions to be assessed. This work has enabled further research on prostate cancer and its biomarkers, and on the development and application of methods to mine, compare, analyze, and visualize pathways constructed from routine data. This is an important development for the reuse of big data in hospitals. PMID:26162314

Patient satisfaction with clinical laboratory services at Tikur Anbessa Specialized Hospital, Addis Ababa, Ethiopia

PubMed Central

Abera, Rodas Getachew; Abota, Boaz Arka; Legese, Melese Hailu; Negesso, Abebe Edao

2017-01-01

Background Monitoring patient satisfaction is an important and useful quality improvement tool for clinical laboratories in particular and health care organizations in general. Thus, this study aimed to assess patient satisfaction toward clinical laboratory services at Tikur Anbessa Specialized Hospital (TASH), Addis Ababa, Ethiopia. Methods A hospital-based cross-sectional study was conducted and a convenient sampling technique was applied to recruit study participants. A total of 210 patients who had received laboratory services were included. A self-administered predesigned, pretested, structured questionnaire was used, and data were collected through face-to-face interviews. A 5-point Likert scale with 1 and 5 indicating the lowest and highest levels of satisfaction, respectively, was used and their weighted average was used to categorize the satisfaction level of the patients. Chi square test was used (taking P≤0.05 as the statistically significant level) to find out if any association existed between the level of satisfaction and different attributes. Data were analyzed using SPSS version 20. Results The overall level of patient satisfaction toward clinical laboratory services in this study was 59.7% with a response rate of 210 (100%). The Likert scale results of patient satisfaction of the laboratory services revealed that the mean rating values ranged from 3.05 (±1.12) to 4.12 (±1.08) out of a possible 5. Among the different indicators, patients were highly satisfied with the cleanliness of facility (82%), maintenance of privacy and confidentiality (83.2%), and the cost of the laboratory service (86.5%), while they were dissatisfied with the location of the laboratory (56%), latrine accessibility and availability (58.4%), and latrine cleanness and comfort (63.8%). Conclusion The whole availability of requested tests, availability of place in blood drawing room to put personal things, and waiting time for specimen collection were found to have a statistically significant association with the overall satisfaction of patients toward clinical laboratory services. Therefore, these could be the possible determinants among others that account for the dissatisfaction of patients with clinical laboratory services. PMID:28761333

The Point-of-Care Laboratory in Clinical Microbiology

PubMed Central

Michel-Lepage, Audrey; Boyer, Sylvie; Raoult, Didier

2016-01-01

SUMMARY Point-of-care (POC) laboratories that deliver rapid diagnoses of infectious diseases were invented to balance the centralization of core laboratories. POC laboratories operate 24 h a day and 7 days a week to provide diagnoses within 2 h, largely based on immunochromatography and real-time PCR tests. In our experience, these tests are conveniently combined into syndrome-based kits that facilitate sampling, including self-sampling and test operations, as POC laboratories can be operated by trained operators who are not necessarily biologists. POC laboratories are a way of easily providing clinical microbiology testing for populations distant from laboratories in developing and developed countries and on ships. Modern Internet connections enable support from core laboratories. The cost-effectiveness of POC laboratories has been established for the rapid diagnosis of tuberculosis and sexually transmitted infections in both developed and developing countries. PMID:27029593

Diagnostic tests in HIV management: a review of clinical and laboratory strategies to monitor HIV-infected individuals in developing countries.

PubMed Central

Kimmel, April D.; Losina, Elena; Freedberg, Kenneth A.; Goldie, Sue J.

2006-01-01

We conducted a systematic review on the performance of diagnostic tests for clinical and laboratory monitoring of HIV-infected adults in developing countries. Diagnostic test information collected from computerized databases, bibliographies and the Internet were categorized as clinical (non-laboratory patient information), immunologic (information from immunologic laboratory tests), or virologic (information from virologic laboratory tests). Of the 51 studies selected for the review 28 assessed immunologic tests, 12 virologic tests and seven clinical and immunologic tests. Methods of performance evaluation were primarily sensitivity and specificity for the clinical category and correlation coefficients for immunologic and virologic categories. In the clinical category, the majority of test performance measures was reported as >70% sensitive and >65% specific. In the immunologic category, correlation coefficients ranged from r=0.54 to r=0.99 for different CD4 count enumeration techniques, while correlation for CD4 and total lymphocyte counts was between r=0.23 and r=0.74. In the virologic category, correlation coefficients for different human immunodeficiency virus (HIV) ribonucleic acid (RNA) quantification techniques ranged from r=0.54 to r=0.90. Future research requires consensus on designing studies, and collecting and reporting data useful for decision-makers. We recommend classifying information into clinically relevant categories, using a consistent definition of disease across studies and providing measures of both association and accuracy. PMID:16878233

To test or not to test? Laboratory support for the diagnosis of Lyme borreliosis: a position paper of ESGBOR, the ESCMID study group for Lyme borreliosis.

PubMed

Dessau, R B; van Dam, A P; Fingerle, V; Gray, J; Hovius, J W; Hunfeld, K-P; Jaulhac, B; Kahl, O; Kristoferitsch, W; Lindgren, P-E; Markowicz, M; Mavin, S; Ornstein, K; Rupprecht, T; Stanek, G; Strle, F

2018-02-01

Lyme borreliosis (LB) is a tick-borne infection caused by Borrelia burgdorferi sensu lato. The most frequent clinical manifestations are erythema migrans and Lyme neuroborreliosis. Currently, a large volume of diagnostic testing for LB is reported, whereas the incidence of clinically relevant disease manifestations is low. This indicates overuse of diagnostic testing for LB with implications for patient care and cost-effective health management. The recommendations provided in this review are intended to support both the clinical diagnosis and initiatives for a more rational use of laboratory testing in patients with clinically suspected LB. This is a narrative review combining various aspects of the clinical and laboratory diagnosis with an educational purpose. The literature search was based on existing systematic reviews, national and international guidelines and supplemented with specific citations. The main recommendations according to current European case definitions for LB are as follows. Typical erythema migrans should be diagnosed clinically and does not require laboratory testing. The diagnosis of Lyme neuroborreliosis requires laboratory investigation of the spinal fluid including intrathecal antibody production, and the remaining disease manifestations require testing for serum antibodies to B. burgdorferi. Testing individuals with non-specific subjective symptoms is not recommended, because of a low positive predictive value. Copyright © 2017 European Society of Clinical Microbiology and Infectious Diseases. All rights reserved.

Diagnostic evaluation of HER-2 as a molecular target: an assessment of accuracy and reproducibility of laboratory testing in large, prospective, randomized clinical trials.

PubMed

Press, Michael F; Sauter, Guido; Bernstein, Leslie; Villalobos, Ivonne E; Mirlacher, Martina; Zhou, Jian-Yuan; Wardeh, Rooba; Li, Yong-Tian; Guzman, Roberta; Ma, Yanling; Sullivan-Halley, Jane; Santiago, Angela; Park, Jinha M; Riva, Alessandro; Slamon, Dennis J

2005-09-15

To critically assess the accuracy and reproducibility of human epidermal growth factor receptor type 2 (HER-2) testing in outside/local community-based hospitals versus two centralized reference laboratories and its effect on selection of women for trastuzumab (Herceptin)-based clinical trials. Breast cancer specimens from 2,600 women were prospectively evaluated by fluorescence in situ hybridization (FISH) for entry into Breast Cancer International Research Group (BCIRG) clinical trials for HER-2-directed therapies. HER-2 gene amplification by FISH was observed in 657 of the 2,502 (26%) breast cancers successfully analyzed. Among 2,243 breast cancers with central laboratory immunohistochemistry (10H8-IHC) analysis, 504 (22.54%) showed overexpression (2+ or 3+). Outside/local laboratories assessed HER-2 status by immunohistochemistry in 1,536 of these cases and by FISH in 131 cases. Overall, the HER-2 alteration status determined by outside/local immunohistochemistry showed a 79% agreement rate [kappa statistic, 0.56; 95% confidence interval (95% CI), 0.52-0.60], with FISH done by the central laboratories. The agreement rate comparing BCIRG central laboratory 10H8-IHC and outside/local laboratory immunohistochemistry was 77.5% (kappa statistic, 0.51; 95% CI, 0.46-0.55). Finally, HER-2 status, determined by unspecified FISH assay methods at outside/local laboratories, showed a 92% agreement rate (kappa statistic, 0.83; 95% CI, 0.73-0.93), with FISH done at the BCIRG central laboratories. Compared with the HER-2 status determined at centralized BCIRG reference laboratories, these results indicate superiority of FISH to accurately and reproducibly assess tumors for the HER-2 alteration at outside/local laboratories for entry to clinical trials.