Testing painted wood : past practices at the Forest Products Laboratory and recommendations for future research

Treesearch

R. Sam Williams

2009-01-01

A brief history of paint research at the Forest Products Laboratory (FPL) in Madison, Wisconsin, sets the stage for a discussion of testing paint on wood and wood products. Tests include laboratory and outdoor tests, and I discuss them in terms of several degradation mechanisms (loss of gloss and fading, mildew growth, extractives bleed, and cracking, flaking, and...

Agreement between allergen-specific IgE assays and ensuing immunotherapy recommendations from four commercial laboratories in the USA

PubMed Central

Plant, Jon D; Neradelik, Moni B; Polissar, Nayak L; Fadok, Valerie A; Scott, Brian A

2014-01-01

Background Canine allergen-specific IgE assays in the USA are not subjected to an independent laboratory reliability monitoring programme. Hypothesis/Objectives The aim of this study was to evaluate the agreement of diagnostic results and treatment recommendations of four serum IgE assays commercially available in the USA. Methods Replicate serum samples from 10 atopic dogs were submitted to each of four laboratories for allergen-specific IgE assays (ACTT®, VARL Liquid Gold, ALLERCEPT® and Greer® Aller-g-complete®). The interlaboratory agreement of standard, regional panels and ensuing treatment recommendations were analysed with the kappa statistic (κ) to account for agreement that might occur merely by chance. Six comparisons of pairs of laboratories and overall agreement among laboratories were analysed for ungrouped allergens (as tested) and also with allergens grouped according to reported cross-reactivity and taxonomy. Results The overall chance-corrected agreement of the positive/negative test results for ungrouped and grouped allergens was slight (κ = 0.14 and 0.13, respectively). Subset analysis of the laboratory pair with the highest level of diagnostic agreement (κ = 0.36) found slight agreement (κ = 0.13) for ungrouped plants and fungi, but substantial agreement (κ = 0.71) for ungrouped mites. The overall agreement of the treatment recommendations was slight (κ = 0.11). Altogether, 85.1% of ungrouped allergen treatment recommendations were unique to one laboratory or another. Conclusions and clinical importance Our study indicated that the choice of IgE assay may have a major influence on the positive/negative results and ensuing treatment recommendations. PMID:24461034

Practical recommendations for strengthening national and regional laboratory networks in Africa in the Global Health Security era.

PubMed

Best, Michele; Sakande, Jean

2016-01-01

The role of national health laboratories in support of public health response has expanded beyond laboratory testing to include a number of other core functions such as emergency response, training and outreach, communications, laboratory-based surveillance and data management. These functions can only be accomplished by an efficient and resilient national laboratory network that includes public health, reference, clinical and other laboratories. It is a primary responsibility of the national health laboratory in the Ministry of Health to develop and maintain the national laboratory network in the country. In this article, we present practical recommendations based on 17 years of network development experience for the development of effective national laboratory networks. These recommendations and examples of current laboratory networks, are provided to facilitate laboratory network development in other states. The development of resilient, integrated laboratory networks will enhance each state's public health system and is critical to the development of a robust national laboratory response network to meet global health security threats.

Practical recommendations for strengthening national and regional laboratory networks in Africa in the Global Health Security era

PubMed Central

2016-01-01

The role of national health laboratories in support of public health response has expanded beyond laboratory testing to include a number of other core functions such as emergency response, training and outreach, communications, laboratory-based surveillance and data management. These functions can only be accomplished by an efficient and resilient national laboratory network that includes public health, reference, clinical and other laboratories. It is a primary responsibility of the national health laboratory in the Ministry of Health to develop and maintain the national laboratory network in the country. In this article, we present practical recommendations based on 17 years of network development experience for the development of effective national laboratory networks. These recommendations and examples of current laboratory networks, are provided to facilitate laboratory network development in other states. The development of resilient, integrated laboratory networks will enhance each state’s public health system and is critical to the development of a robust national laboratory response network to meet global health security threats. PMID:28879137

External quality assessment of medical laboratories in Croatia: preliminary evaluation of post-analytical laboratory testing.

PubMed

Krleza, Jasna Lenicek; Dorotic, Adrijana; Grzunov, Ana

2017-02-15

Proper standardization of laboratory testing requires assessment of performance after the tests are performed, known as the post-analytical phase. A nationwide external quality assessment (EQA) scheme implemented in Croatia in 2014 includes a questionnaire on post-analytical practices, and the present study examined laboratory responses in order to identify current post-analytical phase practices and identify areas for improvement. In four EQA exercises between September 2014 and December 2015, 145-174 medical laboratories across Croatia were surveyed using the Module 11 questionnaire on the post-analytical phase of testing. Based on their responses, the laboratories were evaluated on four quality indicators: turnaround time (TAT), critical values, interpretative comments and procedures in the event of abnormal results. Results were presented as absolute numbers and percentages. Just over half of laboratories (56.3%) monitored TAT. Laboratories varied substantially in how they dealt with critical values. Most laboratories (65-97%) issued interpretative comments with test results. One third of medical laboratories (30.6-33.3%) issued abnormal test results without confirming them in additional testing. Our results suggest that the nationwide post-analytical EQA scheme launched in 2014 in Croatia has yet to be implemented to the full. To close the gaps between existing recommendations and laboratory practice, laboratory professionals should focus on ensuring that TAT is monitored and lists of critical values are established within laboratories. Professional bodies/institutions should focus on clarify and harmonized rules to standardized practices and applied for adding interpretative comments to laboratory test results and for dealing with abnormal test results.

Laboratory or Field Tests for Evaluating Firefighters' Work Capacity?

PubMed Central

Lindberg, Ann-Sofie; Oksa, Juha; Malm, Christer

2014-01-01

Muscle strength is important for firefighters work capacity. Laboratory tests used for measurements of muscle strength, however, are complicated, expensive and time consuming. The aims of the present study were to investigate correlations between physical capacity within commonly occurring and physically demanding firefighting work tasks and both laboratory and field tests in full time (N = 8) and part-time (N = 10) male firefighters and civilian men (N = 8) and women (N = 12), and also to give recommendations as to which field tests might be useful for evaluating firefighters' physical work capacity. Laboratory tests of isokinetic maximal (IM) and endurance (IE) muscle power and dynamic balance, field tests including maximal and endurance muscle performance, and simulated firefighting work tasks were performed. Correlations with work capacity were analyzed with Spearman's rank correlation coefficient (rs). The highest significant (p<0.01) correlations with laboratory and field tests were for Cutting: IE trunk extension (rs = 0.72) and maximal hand grip strength (rs = 0.67), for Stairs: IE shoulder flexion (rs = −0.81) and barbell shoulder press (rs = −0.77), for Pulling: IE shoulder extension (rs = −0.82) and bench press (rs = −0.85), for Demolition: IE knee extension (rs = 0.75) and bench press (rs = 0.83), for Rescue: IE shoulder flexion (rs = −0.83) and bench press (rs = −0.82), and for the Terrain work task: IE trunk flexion (rs = −0.58) and upright barbell row (rs = −0.70). In conclusion, field tests may be used instead of laboratory tests. Maximal hand grip strength, bench press, chin ups, dips, upright barbell row, standing broad jump, and barbell shoulder press were strongly correlated (rs≥0.7) with work capacity and are therefore recommended for evaluating firefighters work capacity. PMID:24614596

Laboratory or field tests for evaluating firefighters' work capacity?

PubMed

Lindberg, Ann-Sofie; Oksa, Juha; Malm, Christer

2014-01-01

Muscle strength is important for firefighters work capacity. Laboratory tests used for measurements of muscle strength, however, are complicated, expensive and time consuming. The aims of the present study were to investigate correlations between physical capacity within commonly occurring and physically demanding firefighting work tasks and both laboratory and field tests in full time (N = 8) and part-time (N = 10) male firefighters and civilian men (N = 8) and women (N = 12), and also to give recommendations as to which field tests might be useful for evaluating firefighters' physical work capacity. Laboratory tests of isokinetic maximal (IM) and endurance (IE) muscle power and dynamic balance, field tests including maximal and endurance muscle performance, and simulated firefighting work tasks were performed. Correlations with work capacity were analyzed with Spearman's rank correlation coefficient (rs). The highest significant (p<0.01) correlations with laboratory and field tests were for Cutting: IE trunk extension (rs = 0.72) and maximal hand grip strength (rs = 0.67), for Stairs: IE shoulder flexion (rs = -0.81) and barbell shoulder press (rs = -0.77), for Pulling: IE shoulder extension (rs = -0.82) and bench press (rs = -0.85), for Demolition: IE knee extension (rs = 0.75) and bench press (rs = 0.83), for Rescue: IE shoulder flexion (rs = -0.83) and bench press (rs = -0.82), and for the Terrain work task: IE trunk flexion (rs = -0.58) and upright barbell row (rs = -0.70). In conclusion, field tests may be used instead of laboratory tests. Maximal hand grip strength, bench press, chin ups, dips, upright barbell row, standing broad jump, and barbell shoulder press were strongly correlated (rs≥0.7) with work capacity and are therefore recommended for evaluating firefighters work capacity.

Agreement between allergen-specific IgE assays and ensuing immunotherapy recommendations from four commercial laboratories in the USA.

PubMed

Plant, Jon D; Neradelik, Moni B; Polissar, Nayak L; Fadok, Valerie A; Scott, Brian A

2014-02-01

Canine allergen-specific IgE assays in the USA are not subjected to an independent laboratory reliability monitoring programme. The aim of this study was to evaluate the agreement of diagnostic results and treatment recommendations of four serum IgE assays commercially available in the USA. Replicate serum samples from 10 atopic dogs were submitted to each of four laboratories for allergen-specific IgE assays (ACTT(®) , VARL Liquid Gold, ALLERCEPT(®) and Greer(®) Aller-g-complete(®) ). The interlaboratory agreement of standard, regional panels and ensuing treatment recommendations were analysed with the kappa statistic (κ) to account for agreement that might occur merely by chance. Six comparisons of pairs of laboratories and overall agreement among laboratories were analysed for ungrouped allergens (as tested) and also with allergens grouped according to reported cross-reactivity and taxonomy. The overall chance-corrected agreement of the positive/negative test results for ungrouped and grouped allergens was slight (κ = 0.14 and 0.13, respectively). Subset analysis of the laboratory pair with the highest level of diagnostic agreement (κ = 0.36) found slight agreement (κ = 0.13) for ungrouped plants and fungi, but substantial agreement (κ = 0.71) for ungrouped mites. The overall agreement of the treatment recommendations was slight (κ = 0.11). Altogether, 85.1% of ungrouped allergen treatment recommendations were unique to one laboratory or another. Our study indicated that the choice of IgE assay may have a major influence on the positive/negative results and ensuing treatment recommendations. © 2014 The Authors. Veterinary Dermatology published by John Wiley & Sons Ltd on behalf of the ESVD and the ACVD.

Antimicrobial susceptibility testing by Australian veterinary diagnostic laboratories.

PubMed

Hardefeldt, L Y; Marenda, M; Crabb, H; Stevenson, M A; Gilkerson, J R; Billman-Jacobe, H; Browning, G F

2018-04-01

The national strategy for tackling antimicrobial resistance highlights the need for antimicrobial stewardship in veterinary practice and for surveillance of antimicrobial susceptibility in veterinary pathogens. Diagnostic laboratories have an important role in facilitating both of these processes, but it is unclear whether data from veterinary diagnostic laboratories are similar enough to allow for compilation and if there is consistent promotion of appropriate antimicrobial use embedded in the approaches of different laboratories to susceptibility testing. A cross-sectional study of antimicrobial susceptibility testing and reporting procedures by Australian veterinary diagnostic laboratories was conducted in 2017 using an online questionnaire. All 18 veterinary diagnostic laboratories in Australia completed the questionnaire. Kirby-Bauer disc diffusion was the method predominantly used for antimicrobial susceptibility testing and was used to evaluate 86% of all isolates, although two different protocols were used across the 18 laboratories (CLSI 15/18, CDS 3/18). Minimum inhibitory concentrations were never reported by 61% of laboratories. Common isolates were consistently reported on across all species, except for gram-negative isolates in pigs, for which there was some variation in the approach to reporting. There was considerable diversity in the panels of antimicrobials used for susceptibility testing on common isolates and no consistency was apparent between laboratories for any bacterial species. We recommend that nationally agreed and consistent antimicrobial panels for routine susceptibility testing should be developed and a uniform set of guidelines should be adopted by veterinary diagnostic laboratories in Australia. © 2018 Australian Veterinary Association.

Recommended design and fabrication sequence of AMTEC test assembly

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

Schock, A.; Kumar, V.; Noravian, H.

1998-01-01

A series of previous OSC papers described: 1) a novel methodology for the coupled thermal, fluid flow, and electrical analysis of multitube AMTEC (Alkali Metal Thermal-to-Electric Conversion) cells; 2) the application of that methodology to determine the effect of numerous design variations on the cell{close_quote}s performance, leading to selection and performance characterization of an OSC-recommended cell design; and 3) the design, analysis, and characterization of an OSC-generated power system design combining sixteen of the above AMTEC cells with two or three GPHS (General Purpose Heat Source) radioisotope heat source modules, and the applicability of those power systems to future spacemore » missions ({ital e.g.} Pluto Express and Europa Orbiter) under consideration by NASA. The OSC system design studies demonstrated the critical importance of the thermal insulation subsystem, and culminated in a design in which the eight AMTEC cells on each end of the heat source stack are embedded in Min-K fibrous insulation, and the Min-K and the GPHS modules are surrounded by graded-length Mo multifoil insulation. The present paper depicts the OSC-recommended AMTEC cell and generator designs, and identifies the need for an electrically heated (scaled-down but otherwise prototypic) test assembly for the experimental validation of the generator{close_quote}s system performance predictions. It then describes the design of an OSC-recommended test assembly consisting of an electrical heater enclosed in a graphite box to simulate the radioisotope heat source, four series-connected prototypic AMTEC cells of the OSC-recommended configuration, and a prototypic hybrid insulation package consisting of Min-K and graded-length Mo multifoils. Finally, the paper describes and illustrates an OSC-recommended detailed fabrication sequence and procedure for the above cell and test assembly. That fabrication procedure is being implemented by AMPS, Inc. with the support of DOE

Internal Quality Control Practices in Coagulation Laboratories: recommendations based on a patterns-of-practice survey.

PubMed

McFarlane, A; Aslan, B; Raby, A; Moffat, K A; Selby, R; Padmore, R

2015-12-01

Internal quality control (IQC) procedures are crucial for ensuring accurate patient test results. The IQMH Centre for Proficiency Testing conducted a web-based survey to gather information on the current IQC practices in coagulation testing. A questionnaire was distributed to 174 Ontario laboratories licensed to perform prothrombin time (PT) and activated partial thromboplastin time (APTT). All laboratories reported using two levels of commercial QC (CQC); 12% incorporate pooled patient plasma into their IQC program; >68% run CQC at the beginning of each shift; 56% following maintenance, with reagent changes, during a shift, or with every repeat sample; 6% only run CQC at the beginning of the day and 25% when the instruments have been idle for a defined period of time. IQC run frequency was determined by manufacturer recommendations (71%) but also influenced by the stability of test (27%), clinical impact of an incorrect test result (25%), and sample's batch number (10%). IQC was monitored using preset limits based on standard deviation (66%), precision goals (46%), or allowable performance limits (36%). 95% use multirules. Failure actions include repeating the IQC (90%) and reporting patient results; if repeat passes, 42% perform repeat analysis of all patient samples from last acceptable IQC. Variability exists in coagulation IQC practices among Ontario clinical laboratories. The recommendations presented here would be useful in encouraging standardized IQC practices. © 2015 John Wiley & Sons Ltd.

Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer

PubMed Central

Wolff, Antonio C.; Hammond, M. Elizabeth H.; Hicks, David G.; Dowsett, Mitch; McShane, Lisa M.; Allison, Kimberly H.; Allred, Donald C.; Bartlett, John M.S.; Bilous, Michael; Fitzgibbons, Patrick; Hanna, Wedad; Jenkins, Robert B.; Mangu, Pamela B.; Paik, Soonmyung; Perez, Edith A.; Press, Michael F.; Spears, Patricia A.; Vance, Gail H.; Viale, Giuseppe; Hayes, Daniel F.

2014-01-01

Purpose To update the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline recommendations for human epidermal growth factor receptor 2 (HER2) testing in breast cancer to improve the accuracy of HER2 testing and its utility as a predictive marker in invasive breast cancer. Methods ASCO/CAP convened an Update Committee that included coauthors of the 2007 guideline to conduct a systematic literature review and update recommendations for optimal HER2 testing. Results The Update Committee identified criteria and areas requiring clarification to improve the accuracy of HER2 testing by immunohistochemistry (IHC) or in situ hybridization (ISH). The guideline was reviewed and approved by both organizations. Recommendations The Update Committee recommends that HER2 status (HER2 negative or positive) be determined in all patients with invasive (early stage or recurrence) breast cancer on the basis of one or more HER2 test results (negative, equivocal, or positive). Testing criteria define HER2-positive status when (on observing within an area of tumor that amounts to >10% of contiguous and homogeneous tumor cells) there is evidence of protein overexpression (IHC) or gene amplification (HER2 copy number or HER2/CEP17 ratio by ISH based on counting at least 20 cells within the area). If results are equivocal (revised criteria), reflex testing should be performed using an alternative assay (IHC or ISH). Repeat testing should be considered if results seem discordant with other histopathologic findings. Laboratories should demonstrate high concordance with a validated HER2 test on a sufficiently large and representative set of specimens. Testing must be performed in a laboratory accredited by CAP or another accrediting entity. The Update Committee urges providers and health systems to cooperate to ensure the highest quality testing. PMID:24099077

Recommendation for the review of biological reference intervals in medical laboratories.

PubMed

Henny, Joseph; Vassault, Anne; Boursier, Guilaine; Vukasovic, Ines; Mesko Brguljan, Pika; Lohmander, Maria; Ghita, Irina; Andreu, Francisco A Bernabeu; Kroupis, Christos; Sprongl, Ludek; Thelen, Marc H M; Vanstapel, Florent J L A; Vodnik, Tatjana; Huisman, Willem; Vaubourdolle, Michel

2016-12-01

This document is based on the original recommendation of the Expert Panel on the Theory of Reference Values of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), updated guidelines were recently published under the auspices of the IFCC and the Clinical and Laboratory Standards Institute (CLSI). This document summarizes proposals for recommendations on: (i) The terminology, which is often confusing, noticeably concerning the terms of reference limits and decision limits. (ii) The method for the determination of reference limits according to the original procedure and the conditions, which should be used. (iii) A simple procedure allowing the medical laboratories to fulfill the requirements of the regulation and standards. The updated document proposes to verify that published reference limits are applicable to the laboratory involved. Finally, the strengths and limits of the revised recommendations (especially the selection of the reference population, the maintenance of the analytical quality, the choice of the statistical method used…) will be briefly discussed.

Position statement executive summary: guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus.

PubMed

Sacks, David B; Arnold, Mark; Bakris, George L; Bruns, David E; Horvath, Andrea Rita; Kirkman, M Sue; Lernmark, Ake; Metzger, Boyd E; Nathan, David M

2011-06-01

Multiple laboratory tests are used in the diagnosis and management of patients with diabetes mellitus. The quality of the scientific evidence supporting the use of these assays varies substantially. An expert committee compiled evidence-based recommendations for the use of laboratory analysis in patients with diabetes. A new system was developed to grade the overall quality of the evidence and the strength of the recommendations. A draft of the guidelines was posted on the Internet, and the document was modified in response to comments. The guidelines were reviewed by the joint Evidence-Based Laboratory Medicine Committee of the AACC and the National Academy of Clinical Biochemistry and were accepted after revisions by the Professional Practice Committee and subsequent approval by the Executive Committee of the American Diabetes Association. In addition to the long-standing criteria based on measurement of venous plasma glucose, diabetes can be diagnosed by demonstrating increased hemoglobin A(1c) (HbA(1c)) concentrations in the blood. Monitoring of glycemic control is performed by the patients measuring their own plasma or blood glucose with meters and by laboratory analysis of HbA(1c). The potential roles of noninvasive glucose monitoring, genetic testing, and measurement of autoantibodies, urine albumin, insulin, proinsulin, C-peptide, and other analytes are addressed. The guidelines provide specific recommendations based on published data or derived from expert consensus. Several analytes are found to have minimal clinical value at the present time, and measurement of them is not recommended.

Trends in laboratory test volumes for Medicare Part B reimbursements, 2000-2010.

PubMed

Shahangian, Shahram; Alspach, Todd D; Astles, J Rex; Yesupriya, Ajay; Dettwyler, William K

2014-02-01

Changes in reimbursements for clinical laboratory testing may help us assess the effect of various variables, such as testing recommendations, market forces, changes in testing technology, and changes in clinical or laboratory practices, and provide information that can influence health care and public health policy decisions. To date, however, there has been no report, to our knowledge, of longitudinal trends in national laboratory test use. To evaluate Medicare Part B-reimbursed volumes of selected laboratory tests per 10,000 enrollees from 2000 through 2010. Laboratory test reimbursement volumes per 10,000 enrollees in Medicare Part B were obtained from the Centers for Medicare & Medicaid Services (Baltimore, Maryland). The ratio of the most recent (2010) reimbursed test volume per 10,000 Medicare enrollees, divided by the oldest data (usually 2000) during this decade, called the volume ratio, was used to measure trends in test reimbursement. Laboratory tests with a reimbursement claim frequency of at least 10 per 10,000 Medicare enrollees in 2010 were selected, provided there was more than a 50% change in test reimbursement volume during the 2000-2010 decade. We combined the reimbursed test volumes for the few tests that were listed under more than one code in the Current Procedural Terminology (American Medical Association, Chicago, Illinois). A 2-sided Poisson regression, adjusted for potential overdispersion, was used to determine P values for the trend; trends were considered significant at P < .05. Tests with the greatest decrease in reimbursement volumes were electrolytes, digoxin, carbamazepine, phenytoin, and lithium, with volume ratios ranging from 0.27 to 0.64 (P < .001). Tests with the greatest increase in reimbursement volumes were meprobamate, opiates, methadone, phencyclidine, amphetamines, cocaine, and vitamin D, with volume ratios ranging from 83 to 1510 (P < .001). Although reimbursement volumes increased for most of the selected tests, other

The role of laboratory in ensuring appropriate test requests.

PubMed

Ferraro, Simona; Panteghini, Mauro

2017-07-01

This review highlights the role of laboratory professionals and the strategies to be promoted in strict cooperation with clinicians for auditing, monitoring and improving the appropriateness of test request. The introduction of local pathways and care maps in agreement with international and national guidelines as well as the implementation of reflex testing and algorithms have a central role in guiding test request and in correcting the overuse/misuse of tests. Furthermore, removing obsolete tests from laboratory menu and vetting of restricted tests is recommended to increase cost-effectiveness. This saves costs and permits to introduce new biomarkers with increased diagnostic accuracy with a better impact on patient outcome. An additional issue is concerning the periodicity of (re)testing, accounting that only a minority of tests may be ordered as often as necessary. In the majority of cases, a minimum retesting interval should be introduced. The availability of effective computerised order entry systems is relevant in ensuring appropriate test requests and in providing an aid by automated rules that may stop inappropriate requests before they reach the laboratory. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Position Statement Executive Summary: Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus

PubMed Central

Arnold, Mark; Bakris, George L.; Bruns, David E.; Horvath, Andrea Rita; Kirkman, M. Sue; Lernmark, Ake; Metzger, Boyd E.; Nathan, David M.

2011-01-01

BACKGROUND Multiple laboratory tests are used in the diagnosis and management of patients with diabetes mellitus. The quality of the scientific evidence supporting the use of these assays varies substantially. APPROACH An expert committee compiled evidence-based recommendations for the use of laboratory analysis in patients with diabetes. A new system was developed to grade the overall quality of the evidence and the strength of the recommendations. A draft of the guidelines was posted on the Internet, and the document was modified in response to comments. The guidelines were reviewed by the joint Evidence-Based Laboratory Medicine Committee of the AACC and the National Academy of Clinical Biochemistry and were accepted after revisions by the Professional Practice Committee and subsequent approval by the Executive Committee of the American Diabetes Association. CONTENT In addition to the long-standing criteria based on measurement of venous plasma glucose, diabetes can be diagnosed by demonstrating increased hemoglobin A1c (HbA1c) concentrations in the blood. Monitoring of glycemic control is performed by the patients measuring their own plasma or blood glucose with meters and by laboratory analysis of HbA1c. The potential roles of noninvasive glucose monitoring, genetic testing, and measurement of autoantibodies, urine albumin, insulin, proinsulin, C-peptide, and other analytes are addressed. SUMMARY The guidelines provide specific recommendations based on published data or derived from expert consensus. Several analytes are found to have minimal clinical value at the present time, and measurement of them is not recommended. PMID:21617111

Maintaining Life-saving Testing for Patients With Infectious Diseases: Infectious Diseases Society of America, American Society for Microbiology, and Pan American Society for Clinical Virology Recommendations on the Regulation of Laboratory-developed Tests.

PubMed

Caliendo, Angela M; Couturier, Marc R; Ginocchio, Christine C; Hanson, Kimberly E; Miller, Melissa B; Walker, Kimberly E; Frank, Gregory M

2016-07-15

In 2014, the US Food and Drug Administration (FDA) proposed to regulate laboratory-developed tests (LDTs)-diagnostics designed, manufactured, and used within a single laboratory. The Infectious Diseases Society of America, the American Society for Microbiology, and the Pan American Society for Clinical Virology recognize that the FDA is committed to protecting patients. However, our societies are concerned that the proposed regulations will limit access to testing and negatively impact infectious diseases (ID) LDTs. In this joint commentary, our societies discuss why LDTs are critical for ID patient care, hospital infection control, and public health responses. We also highlight how the FDA's proposed regulation of LDTs could impair patient access to life-saving tests and stifle innovation in ID diagnostics. Finally, our societies make specific recommendations for the FDA's consideration to reduce the burden of the proposed new rules on clinical laboratories and protect patients' access to state-of-the art, quality LDTs. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

Croatian Society of Medical Biochemistry and Laboratory Medicine: national recommendations for venous blood sampling

PubMed Central

Nikolac, Nora; Šupak-Smolčić, Vesna; Šimundić, Ana-Maria; Ćelap, Ivana

2013-01-01

Phlebotomy is one of the most complex medical procedures in the diagnosis, management and treatment of patients in healthcare. Since laboratory test results are the basis for a large proportion (60–80%) of medical decisions, any error in the phlebotomy process could have serious consequences. In order to minimize the possibility of errors, phlebotomy procedures should be standardised, well-documented and written instructions should be available at every workstation. Croatia is one of the few European countries that have national guidelines for phlebotomy, besides the universally used CLSI (Clinical Laboratory Standards Institute) H3-A6 Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; approved Standard-Sixth Edition (CLSI, 2007) and WHO (World Health Organization) guidelines on drawing blood: best practices in phlebotomy (WHO, 2010). However, the growing body of evidence in importance of preanalytical phase management resulted in a need for evidence based revision and expansion of existing recommendations. The Croatian Society for Medical Biochemistry and Laboratory Medicine, Working Group for the Preanalytical Phase issued this recommendation. This document is based on the CLSI guideline H3-A6, with significant differences and additional information. PMID:24266294

Croatian Society of Medical Biochemistry and Laboratory Medicine: national recommendations for venous blood sampling.

PubMed

Nikolac, Nora; Supak-Smolcić, Vesna; Simundić, Ana-Maria; Celap, Ivana

2013-01-01

Phlebotomy is one of the most complex medical procedures in the diagnosis, management and treatment of patients in healthcare. Since laboratory test results are the basis for a large proportion (60-80%) of medical decisions, any error in the phlebotomy process could have serious consequences. In order to minimize the possibility of errors, phlebotomy procedures should be standardised, well-documented and written instructions should be available at every workstation. Croatia is one of the few European countries that have national guidelines for phlebotomy, besides the universally used CLSI (Clinical Laboratory Standards Institute) H3-A6 Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; approved Standard-Sixth Edition (CLSI, 2007) and WHO (World Health Organization) guidelines on drawing blood: best practices in phlebotomy (WHO, 2010). However, the growing body of evidence in importance of preanalytical phase management resulted in a need for evidence based revision and expansion of existing recommendations. The Croatian Society for Medical Biochemistry and Laboratory Medicine, Working Group for the Preanalytical Phase issued this recommendation. This document is based on the CLSI guideline H3-A6, with significant differences and additional information.

Valid methods: the quality assurance of test method development, validation, approval, and transfer for veterinary testing laboratories.

PubMed

Wiegers, Ann L

2003-07-01

Third-party accreditation is a valuable tool to demonstrate a laboratory's competence to conduct testing. Accreditation, internationally and in the United States, has been discussed previously. However, accreditation is only I part of establishing data credibility. A validated test method is the first component of a valid measurement system. Validation is defined as confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled. The international and national standard ISO/IEC 17025 recognizes the importance of validated methods and requires that laboratory-developed methods or methods adopted by the laboratory be appropriate for the intended use. Validated methods are therefore required and their use agreed to by the client (i.e., end users of the test results such as veterinarians, animal health programs, and owners). ISO/IEC 17025 also requires that the introduction of methods developed by the laboratory for its own use be a planned activity conducted by qualified personnel with adequate resources. This article discusses considerations and recommendations for the conduct of veterinary diagnostic test method development, validation, evaluation, approval, and transfer to the user laboratory in the ISO/IEC 17025 environment. These recommendations are based on those of nationally and internationally accepted standards and guidelines, as well as those of reputable and experienced technical bodies. They are also based on the author's experience in the evaluation of method development and transfer projects, validation data, and the implementation of quality management systems in the area of method development.

The Production of Polyclonal Antibodies in Laboratory Animals. The Report and Recommendations of ECVAM Workshop 35.

PubMed

Leenaars, P P; Hendriksen, C F; de Leeuw, W A; Carat, F; Delahaut, P; Fischer, R; Halder, M; Hanly, W C; Hartinger, J; Hau, J; Lindblad, E B; Nicklas, W; Outschoorn, I M; Stewart-Tull, D E

1999-01-01

This is the report of the thirty-fifth of a series of workshops organised by the European Centre for the Validation of Alternative Methods (ECVAM). ECVAM's main goal, as defined in 1993 by its Scientific Advisory Committee, is to promote the scientific and regulatory acceptance of alternative methods which are of importance to the biosciences and which reduce, refine or replace the use of laboratory animals. One of the first priorities set by ECVAM was the implementation of procedures which would enable it to become well informed about the state-of-the-art of non-animal test development and validation, and the potential for the possible incorporation of alternative tests into regulatory procedures. It was decided that this would be best achieved by the organisation of ECVAM workshops on specific topics, at which small groups of invited experts would review the current status of various types of in vitro tests and their potential uses, and make recommendations about the best ways forward (1). This joint ECVAM/FELASA (Federation of European Laboratory Animal Science Associations) workshop on The Immunisation of Laboratory Animals for the Production of Polyclonal Antibodies was held in Utrecht (The Netherlands), on 20-22 March 1998, under the co-chairmanship of Coenraad Hendriksen (RIVM, Bilthoven, The Netherlands) and Wim de Leeuw (Inspectorate for Health Protection, The Netherlands). The participants, all experts in the fields of immunology, laboratory animal science, or regulation, came from universities, industry and regulatory bodies. The aims of the workshop were: a) to discuss and evaluate current immunisation procedures for the production of polyclonal antibodies (including route of injection, animal species and adjuvant ); and b) to draft recommendations and guidelines to improve the immunisation procedures, with regard both to animal welfare and to the optimisation of immunisation protocols. This report summarises the outcome of the discussions and includes

Approaches to quality management and accreditation in a genetic testing laboratory

PubMed Central

Berwouts, Sarah; Morris, Michael A; Dequeker, Elisabeth

2010-01-01

Medical laboratories, and specifically genetic testing laboratories, provide vital medical services to different clients: clinicians requesting a test, patients from whom the sample was collected, public health and medical-legal instances, referral laboratories and authoritative bodies. All expect results that are accurate and obtained in an efficient and effective manner, within a suitable time frame and at acceptable cost. There are different ways of achieving the end results, but compliance with International Organization for Standardization (ISO) 15189, the international standard for the accreditation of medical laboratories, is becoming progressively accepted as the optimal approach to assuring quality in medical testing. We present recommendations and strategies designed to aid genetic testing laboratories with the implementation of a quality management system, including key aspects such as document control, external quality assessment, internal quality control, internal audit, management review, validation, as well as managing the human side of change. The focus is on pragmatic approaches to attain the levels of quality management and quality assurance required for accreditation according to ISO 15189, within the context of genetic testing. Attention is also given to implementing efficient and effective quality improvement. PMID:20720559

Recommendations for accreditation of laboratories in molecular biology of hematologic malignancies.

PubMed

Flandrin-Gresta, Pascale; Cornillet, Pascale; Hayette, Sandrine; Gachard, Nathalie; Tondeur, Sylvie; Mauté, Carole; Cayuela, Jean-Michel

2015-01-01

Over recent years, the development of molecular biology techniques has improved the hematological diseases diagnostic and follow-up. Consequently, these techniques are largely used in the biological screening of these diseases; therefore the Hemato-oncology molecular diagnostics laboratories must be actively involved in the accreditation process according the ISO 15189 standard. The French group of molecular biologists (GBMHM) provides requirements for the implementation of quality assurance for the medical molecular laboratories. This guideline states the recommendations for the pre-analytical, analytical (methods validation procedures, quality controls, reagents), and post-analytical conditions. In addition, herein we state a strategy for the internal quality control management. These recommendations will be regularly updated.

ASVCP quality assurance guidelines: external quality assessment and comparative testing for reference and in-clinic laboratories.

PubMed

Camus, Melinda S; Flatland, Bente; Freeman, Kathleen P; Cruz Cardona, Janice A

2015-12-01

The purpose of this document is to educate providers of veterinary laboratory diagnostic testing in any setting about comparative testing. These guidelines will define, explain, and illustrate the importance of a multi-faceted laboratory quality management program which includes comparative testing. The guidelines will provide suggestions for implementation of such testing, including which samples should be tested, frequency of testing, and recommendations for result interpretation. Examples and a list of vendors and manufacturers supplying control materials and services to veterinary laboratories are also included. © 2015 American Society for Veterinary Clinical Pathology.

Core outcome measures for opioid abuse liability laboratory assessment studies in humans: IMMPACT recommendations

PubMed Central

Comer, Sandra D.; Zacny, James P.; Dworkin, Robert H.; Turk, Dennis C.; Bigelow, George E.; Foltin, Richard W.; Jasinski, Donald R.; Sellers, Edward M.; Adams, Edgar H.; Balster, Robert; Burke, Laurie B.; Cerny, Igor; Colucci, Robert D.; Cone, Edward; Cowan, Penney; Farrar, John T.; Haddox, J. David; Haythornthwaite, Jennifer A.; Hertz, Sharon; Jay, Gary W.; Johanson, Chris-Ellyn; Junor, Roderick; Katz, Nathaniel P.; Klein, Michael; Kopecky, Ernest A.; Leiderman, Deborah B.; McDermott, Michael P.; O’Brien, Charles; O’Connor, Alec B.; Palmer, Pamela P.; Raja, Srinivasa N.; Rappaport, Bob A.; Rauschkolb, Christine; Rowbotham, Michael C.; Sampaio, Cristina; Setnik, Beatrice; Sokolowska, Marta; Stauffer, Joseph W.; Walsh, Sharon L.

2012-01-01

A critical component in development of opioid analgesics is assessment of their abuse liability (AL). Standardization of approaches and measures used in assessing AL has the potential to facilitate comparisons across studies, research laboratories, and drugs. The goal of this report is to provide consensus recommendations regarding core outcome measures for assessing abuse potential of opioid medications in humans in a controlled laboratory setting. Although many of the recommended measures are appropriate for assessing the AL of medications from other drug classes, the focus here is on opioid medications because they present unique risks from both physiological (e.g., respiratory depression, physical dependence) and public health (e.g., individuals in pain) perspectives. A brief historical perspective on AL testing is provided and then those measures that can be considered primary and secondary outcomes and possible additional outcomes in AL assessment are discussed. These outcome measures include: (1) subjective effects (some of which comprise the primary outcome measures, including drug liking); (2) physiological responses; (3) drug self-administration behavior; and (4) cognitive and psychomotor performance. Prior to presenting recommendations for standardized approaches and measures to be used in AL assessments, the appropriateness of using these measures in clinical trials with patients in pain is discussed. PMID:22998781

Basic haemoglobinopathy diagnostics in Dutch laboratories; providing an informative test result.

PubMed

Kaufmann, J O; Smit, J W; Huisman, W; Idema, R N; Bakker, E; Giordano, P C

2013-08-01

After a first survey in 2001, the Dutch Association of Hematological Laboratory Research (VHL) advised its members to adopt a basic protocol for haemoglobinopathy carrier detection and to provide genetic information with all positive results to allow health-care professionals to inform carriers about potential genetic risks. This article reports on the compliance with these recommendations and their consequences. Clinical chemists of all 106 Dutch laboratories were invited to answer a survey on patient population, diagnostic techniques used, (self-reported) knowledge, use and effect of the additional information. The average increase in diagnostic output was over 60% and the recommended basic protocol was applied by 65% of the laboratories. Over 84% of the laboratories reported to be aware of the additional recommendations and 77% to be using them. Most laboratories with limited diagnostic requests were still sending their cases to other laboratories and included the genetic information received from these laboratories in their diagnostic reports. The effect of information on subsequent 'family analysis' was estimated to be between 26 and 50%. The present study shows an increase in diagnostic potential for haemoglobinopathy over the last decade, especially in the larger cities. Low 'family testing' rates were mostly found in areas with lower carrier prevalence or associated with local reluctance to pass the information to carriers. In spite of a dramatic improvement, too many carriers are still not informed because of lack of awareness among health-care providers and more education is needed. © 2012 John Wiley & Sons Ltd.

Announcement: Guidance for U.S. Laboratory Testing for Zika Virus Infection: Implications for Health Care Providers.

PubMed

2016-11-25

CDC has released updated guidance online for U.S. laboratory testing for Zika virus infection. The guidance is available at https://www.cdc.gov/zika/laboratories/lab-guidance.html. Frequently asked questions are addressed at https://www.cdc.gov/zika/laboratories/lab-guidance-faq.html. This guidance updates recommendations for testing of specimens by U.S. laboratories for possible Zika virus infection. Major updates to the guidance with clinical implications for health care providers include the following.

Microscopic or occult hematuria, when reflex testing is not good laboratory practice.

PubMed

Froom, Paul; Barak, Mira

2010-01-01

Consensus opinion suggests that hematuria found by dipstick and not confirmed on microscopic examination (<2 erythrocytes per high power field) signifies a false-positive reagent strip test result. Standard practice is to repeat the dipstick test several days later and if still positive to confirm by microscopic examination. If discordant results are obtained, experts recommend reflex testing for urinary myoglobin and hemoglobin concentrations. The question is whether or not this approach represents good laboratory practice. These recommendations are not evidence based. We conclude that the reference range for red blood cells on the reagent strip should be increased to 25x10(6) cells/L for young men, and 50x10(6) cells/L for the rest of the adult population, ranges consistent with flow cytometry reports. Confirmation reflex testing using tests that have inferior sensitivity, precision and probably accuracy is not recommended.

[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.

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.

Educational ultrasound nondestructive testing laboratory.

PubMed

Genis, Vladimir; Zagorski, Michael

2008-09-01

The ultrasound nondestructive evaluation (NDE) of materials course was developed for applied engineering technology students at Drexel University's Goodwin College of Professional Studies. This three-credit, hands-on laboratory course consists of two parts: the first part with an emphasis on the foundations of NDE, and the second part during which ultrasound NDE techniques are utilized in the evaluation of parts and materials. NDE applications are presented and applied through real-life problems, including calibration and use of the latest ultrasonic testing instrumentation. The students learn engineering and physical principles of measurements of sound velocity in different materials, attenuation coefficients, material thickness, and location and dimensions of discontinuities in various materials, such as holes, cracks, and flaws. The work in the laboratory enhances the fundamentals taught during classroom sessions. This course will ultimately result in improvements in the educational process ["The greater expectations," national panel report, http://www.greaterexpectations.org (last viewed February, 2008); R. M. Felder and R. Brent "The intellectual development of Science and Engineering Students. Part 2: Teaching to promote growth," J. Eng. Educ. 93, 279-291 (2004)] since industry is becoming increasingly reliant on the effective application of NDE technology and the demand on NDE specialists is increasing. NDE curriculum was designed to fulfill levels I and II NDE in theory and training requirements, according to American Society for Nondestructive Testing, OH, Recommended Practice No. SNT-TC-1A (2006).

Nomenclature in laboratory robotics and automation (IUPAC Recommendation 1994)

PubMed Central

(Skip) Kingston, H. M.; Kingstonz, M. L.

1994-01-01

These recommended terms have been prepared to help provide a uniform approach to terminology and notation in laboratory automation and robotics. Since the terminology used in laboratory automation and robotics has been derived from diverse backgrounds, it is often vague, imprecise, and in some cases, in conflict with classical automation and robotic nomenclature. These dejinitions have been assembled from standards, monographs, dictionaries, journal articles, and documents of international organizations emphasizing laboratory and industrial automation and robotics. When appropriate, definitions have been taken directly from the original source and identified with that source. However, in some cases no acceptable definition could be found and a new definition was prepared to define the object, term, or action. Attention has been given to defining specific robot types, coordinate systems, parameters, attributes, communication protocols and associated workstations and hardware. Diagrams are included to illustrate specific concepts that can best be understood by visualization. PMID:18924684

Laboratory testing in hyperthyroidism.

PubMed

Grebe, Stefan K G; Kahaly, George J

2012-09-01

The clinical diagnosis of hypo- or hyperthyroidism is difficult (full text available online: http://education.amjmed.com/pp1/272). Clinical symptoms and signs are often non-specific, and there is incomplete correlation between structural and functional thyroid gland changes. Laboratory testing is therefore indispensible in establishing the diagnosis of thyrotoxicosis. Similar considerations apply to treatment monitoring. Laboratory testing also plays a crucial role in establishing the most likely cause for a patient's hyperthyroidism. Finally, during pregnancy, when isotopic scanning is relatively contraindicated and ultrasound is more difficult to interpret, laboratory testing becomes even more important. Copyright © 2012. Published by Elsevier Inc.

Laboratory-based testing to evaluate abuse-deterrent formulations and satisfy the Food and Drug Administration's recommendation for Category 1 Testing.

PubMed

Altomare, Christopher; Kinzler, Eric R; Buchhalter, August R; Cone, Edward J; Costantino, Anthony

The US Food and Drug Administration (FDA) considers the development of abuse-deterrent formulations of solid oral dosage forms a public health priority and has outlined a series of premarket studies that should be performed prior to submitting an application to the Agency. Category 1 studies are performed to characterize whether the abuse-deterrent properties of a new formulation can be easily defeated. Study protocols are designed to evaluate common abuse patterns of prescription medications as well as more advanced methods that have been reported on drug abuse websites and forums. Because FDA believes Category 1 testing should fully characterize the abuse-deterrent characteristics of an investigational formulation, Category 1 testing is time consuming and requires specialized laboratory resources as well as advanced knowledge of prescription medication abuse. Recent Advisory Committee meetings at FDA have shown that Category 1 tests play a critical role in FDA's evaluation of an investigational formulation. In this article, we will provide a general overview of the methods of manipulation and routes of administration commonly utilized by prescription drug abusers, how those methods and routes are evaluated in a laboratory setting, and discuss data intake, analysis, and reporting to satisfy FDA's Category 1 testing requirements.

40 CFR 790.20 - Recommendation, recommendation with an intent to designate, and designation of testing candidates...

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 32 2011-07-01 2011-07-01 false Recommendation, recommendation with an... and Test Rules §790.20 Recommendation, recommendation with an intent to designate, and designation of testing candidates by the ITC. (a) ITC recommendations and recommendations with intent to designate. The...

Optimal dilution susceptibility testing conditions, recommendations for MIC interpretation, and quality control guidelines for the ampicillin-sulbactam combination.

PubMed Central

Jones, R N; Barry, A L

1987-01-01

The ampicillin-sulbactam combination was evaluated in vitro to determine the optimal susceptibility testing conditions among five combination ratios and four fixed concentrations of sulbactam. The organisms tested were markedly resistant to aminopenicillins and most other beta-lactams. The ratio of 2:1 is recommended to assure recognition of the ampicillin-sulbactam spectrum and minimize false-susceptible results among strains known to be resistant to this combination. Proposed MIC breakpoint concentrations were compatible with levels in serum achieved with recommended clinical doses. Cross-resistance analyses comparing ampicillin-sulbactam and amoxicillin-clavulanate showed comparable activity and spectra. However, the major interpretive disagreement was sufficient to require separate testing of these aminopenicillin-inhibitor combinations. The recommended ampicillin-sulbactam MIC susceptibility breakpoints are as follows: (i) less than or equal to 8.0/4.0 micrograms/ml for tests against members of the family Enterobacteriaceae, anaerobes, nonenteric gram-negative bacilli, staphylococci, Haemophilus influenzae, and Branhamella catarrhalis; (ii) the ampicillin MICs alone interpreted by National Committee for Clinical Laboratory Standards criteria should predict ampicillin-sulbactam susceptibility for the enterococci, streptococci, and Listeria monocytogenes. MIC quality control ranges were determined by multiple laboratory broth microdilution trials for the ampicillin-sulbactam 1:1 and 2:1 ratio tests. PMID:3117843

An electronic thesaurus of Evidence Based Laboratory Medicine hematological and biochemical diagnostic tests.

PubMed

Dorizzi, R M; Maconi, M; Giavarina, D; Loza, G; Aman, M; Moreira, J; Bisoffi, Z; Gennuso, C

2009-10-01

The adoption of Evidence Based Laboratory Medicine (EBLM) has been hampered until today by the lack of effective tools. The SIMeL EBLM e-Thesaurus (on-line Repertoire of the diagnostic effectiveness of the laboratory, radiology and cardiology test) provides a useful support to clinical laboratory professionals and to clinicians for the interpretation of the diagnostic tests. The e-Thesaurus is an application developed using Microsoft Active Server Pages technology and carried out with Web Server Microsoft Internet Information Server and is available at the SIMeL website using a browser running JavaScript scripts (Internet Explorer is recommended). It contains a database (in Italian, English and Spanish) of the sensitivity and specificity (including the 95% confidence interval), the positive and negative likelihood ratios, the Diagnostic Odds Ratio and the Number Needed to Diagnose of more than 2000 diagnostic (most laboratory but also cardiology and radiology) tests. The e-Thesaurus improves the previous SIMeL paper and CD Thesaurus; its main features are a three languages search and a continuous and an easy updating capability.

Endorsing good quality assurance practices in molecular pathology: risks and recommendations for diagnostic laboratories and external quality assessment providers.

PubMed

Tembuyser, Lien; Dequeker, Elisabeth M C

2016-01-01

Quality assurance is an indispensable element in a molecular diagnostic laboratory. The ultimate goal is to warrant patient safety. Several risks that can compromise high quality procedures are at stake, from sample collection to the test performed by the laboratory, the reporting of test results to clinicians, and the organization of effective external quality assessment schemes. Quality assurance should therefore be safeguarded at each level and should imply a holistic multidisciplinary approach. This review aims to provide an overview of good quality assurance practices and discusses certain risks and recommendations to promote and improve quality assurance for both diagnostic laboratories and for external quality assessment providers. The number of molecular targets is continuously rising, and new technologies are evolving. As this poses challenges for clinical implementation and increases the demand for external quality assessment, the formation of an international association for improving quality assurance in molecular pathology is called for.

Laboratory Diagnosis and Susceptibility Testing for Mycobacterium tuberculosis.

PubMed

Procop, Gary W

2016-12-01

The laboratory, which utilizes some of the most sophisticated and rapidly changing technologies, plays a critical role in the diagnosis of tuberculosis. Some of these tools are being employed in resource-challenged countries for the rapid detection and characterization of Mycobacterium tuberculosis. Foremost, the laboratory defines appropriate specimen criteria for optimal test performance. The direct detection of mycobacteria in the clinical specimen, predominantly done by acid-fast staining, may eventually be replaced by rapid-cycle PCR. The widespread use of the Xpert MTB/RIF (Cepheid) assay, which detects both M. tuberculosis and key genetic determinants of rifampin resistance, is important for the early detection of multidrug-resistant strains. Culture, using both broth and solid media, remains the standard for establishing the laboratory-based diagnosis of tuberculosis. Cultured isolates are identified far less commonly by traditional biochemical profiling and more commonly by molecular methods, such as DNA probes and broad-range PCR with DNA sequencing. Non-nucleic acid-based methods of identification, such as high-performance liquid chromatography and, more recently, matrix-assisted laser desorption/ionization-time of flight mass spectrometry, may also be used for identification. Cultured isolates of M. tuberculosis should be submitted for susceptibility testing according to standard guidelines. The use of broth-based susceptibility testing is recommended to significantly decrease the time to result. Cultured isolates may also be submitted for strain typing for epidemiologic purposes. The use of massive parallel sequencing, also known as next-generation sequencing, promises to continue to this molecular revolution in mycobacteriology, as whole-genome sequencing provides identification, susceptibility, and typing information simultaneously.

3. VIEW LOOKING NORTH, COMPONENTS TEST LABORATORY, DYNAMIC TEST FACILITY ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

3. VIEW LOOKING NORTH, COMPONENTS TEST LABORATORY, DYNAMIC TEST FACILITY (SATURN V IN BACKGROUND). - Marshall Space Flight Center, East Test Area, Components Test Laboratory, Huntsville, Madison County, AL

Recommended practice for laboratory reporting of non‐invasive prenatal testing of trisomies 13, 18 and 21: a consensus opinion

PubMed Central

Allen, Stephanie; Jenkins, Lucy; Khawaja, Farrah; Hastings, Ros J.; Mann, Kathy; Patton, Simon J.; Sistermans, Erik A.; Chitty, Lyn S.

2017-01-01

Abstract Objective Non‐invasive prenatal testing (NIPT) for trisomies 13, 18 and 21 is used worldwide. Laboratory reports should provide clear, concise results with test limitations indicated, yet no national or local guidelines are currently available. Here, we aim to present minimum best practice guidelines. Methods All laboratories registered in the three European quality assurance schemes for molecular and cytogenetics were invited to complete an online survey focused on services provided for NIPT and non‐invasive prenatal diagnosis. Laboratories delivering NIPT for aneuploidy were asked to submit two example reports; one high and one low risk result. Reports were reviewed for content and discussed at a meeting of laboratory providers and clinicians held at the ISPD 2016 conference in Berlin. Results Of the 122 laboratories that responded, 50 issued reports for NIPT and 43 of these submitted sample reports. Responses and reports were discussed by 72 attendees at the meeting. Consensus opinion was determined in several areas and used to develop best practice guidelines for reporting of NIPT results. Conclusions Across Europe, there is considerable variation in reporting NIPT results. Here, we describe minimum best practice guidelines, which will be distributed to European laboratories, and reports audited in subsequent external quality assurance cycles. © 2017 The Authors. Prenatal Diagnosis published by John Wiley & Sons, Ltd. PMID:28497584

Current issues of personnel and laboratory practices in genetic testing

PubMed Central

Mark, Hon Fong Louie; Kelly, Thaddeus; Watson, Michael S; Hoeltge, Gerald; Miller, Wayne A; Beauregard, Laurent

1995-01-01

As genetic testing is an area with implications extending far beyond that of the primary patient, it is appropriately an area that is under increased scrutiny. To ensure that high quality is maintained in the delivery of genetic services, several agencies have developed standards and guidelines. The present article summarises important recommendations made by the American College of Medical Genetics (ACMG), the College of American Pathologists (CAP), the US Health Care Financing Administration (HCFA), and the US Food and Drug Administration (FDA) as they relate to genetic testing. Some of the standards are based on voluntary compliance, whereas others have the force of regulation. They all address issues of personnel credentials, laboratory operations, and the most critical quality assurance and control measures for diagnostic laboratories from the perspective of various agencies. In most instances, the standards promulgated by these agencies are offered as minimum criteria. The exact impact of these regulations on the practice of medical genetics has yet to be established. Images PMID:8558555

Biosecurity management recommendations for rinderpest laboratories

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

Brodsky, Benjamin H; Caskey, Susan Adele; Arndt, William

2014-10-01

Rinderpest is a virus that can affect cattle and other even toes ungulates; evidence of outbreaks from over 10,000 years ago highlights the potential impact of this virus. During the 18th century, Rinderpest caused huge losses in cattle throughout Europe. Starting in the mid 1900’s vaccination efforts seemed feasible and work was initiated to vaccinate large populations of cattle. Walter Plowright received numerous awards for updating the Rinderpest vaccine which many believed would be the key to eradication. Vaccination of the disease lead to a massive drop in outbreaks and the last confirmed case of Rinderpest in Asia was inmore » 2000 and in Africa in 2001.1 At this point, Rinderpest has been declared eradicated from nature. However, stocks of the virus are still in many laboratories.2 Rinderpest was investigated as a biological weapon agent during the Second World War. However, following WWII, rinderpest was not considered a high risk as a biological weapon as there was no direct military advantage. Now, with the concern of the use of biological agents as weapons in acts of terrorism, concern regarding rinderpest has resurfaced. Since the eradication of this virus, cattle populations are highly susceptibility to the virus and the economic impacts would be significant. This paper will discuss the specific nature of the terrorism risks associated with rinderpest; and based upon those risks provide recommendations regarding biosecurity management. The biosecurity management measures will be defined in a manner to align with the CWA 15793: the laboratory biorisk management document.« less

Leaching Test Relationships, Laboratory-to-Field Comparisons and Recommendations for Leaching Evaluation using the Leaching Environmental Assessment Framework (LEAF)

EPA Science Inventory

This report presents examples of the relationships between the results of laboratory leaching tests, as defined by the Leaching Environmental Assessment Framework (LEAF) or analogous international test methods, and leaching of constituents from a broad range of materials under di...

The quality and scope of information provided by medical laboratories to patients before laboratory testing: Survey of the Working Group for Patient Preparation of the Croatian Society of Medical Biochemistry and Laboratory Medicine.

PubMed

Nikolac, Nora; Simundic, Ana-Maria; Kackov, Sanja; Serdar, Tihana; Dorotic, Adrijana; Fumic, Ksenija; Gudasic-Vrdoljak, Jelena; Klenkar, Kornelija; Sambunjak, Jadranka; Vidranski, Valentina

2015-10-23

The aim of this work was to evaluate to what extent the scope and content of information provided to patients is standardized across medical biochemistry laboratories in Croatia. Two on-line self-report surveys were sent out: Survey A regarding attitudes on importance of patient preparation and Survey B on the contents of patient preparation instructions. 13/118 laboratories (11%) do not provide written instructions to patients on how to prepare for laboratory testing, and 36 (40%) do not include information about water intake in their instructions. Only half of laboratories provide instructions for prostate-specific antigen (53.8%), female sex hormones (53.7%) and therapeutic drug monitoring (TDM) (52.5%). Inadequate information about fasting status (55.0%) and 24 hour urine collection (77.9%) were frequent errors with high severity and were associated with the greatest potential to cause patient harm. Laboratory professionals in Croatia have a positive attitude towards the importance of patient preparation for laboratory testing. However, the information for laboratory testing is not standardized and frequently lacks guidance for tests related to TDM, coagulation and endocrinology. This study highlights the need for standardized, updated and evidence-based recommendations for patient preparation in order to minimize the risk for patients. Copyright © 2015 Elsevier B.V. All rights reserved.

Quality performance of laboratory testing in pharmacies: a collaborative evaluation.

PubMed

Zaninotto, Martina; Miolo, Giorgia; Guiotto, Adriano; Marton, Silvia; Plebani, Mario

2016-11-01

The quality performance and the comparability between results of pharmacies point-of-care-testing (POCT) and institutional laboratories have been evaluated. Eight pharmacies participated in the project: a capillary specimen collected by the pharmacist and, simultaneously, a lithium-heparin sample drawn by a physician of laboratory medicine for the pharmacy customers (n=106) were analyzed in the pharmacy and in the laboratory, respectively. Glucose, cholesterol, HDL-cholesterol, triglycerides, creatinine, uric acid, aspartate aminotransferase, alanine aminotransferase, were measured using: Reflotron, n=5; Samsung, n=1; Cardiocheck PA, n=1; Cholestech LDX, n=1 and Cobas 8000. The POCT analytical performance only (phase 2) were evaluated testing, in pharmacies and in the laboratory, the lithium heparin samples from a female drawn fasting daily in a week, and a control sample containing high concentrations of glucose, cholesterol and triglycerides. For all parameters, except triglycerides, the slopes showed a satisfactory correlation. For triglycerides, a median value higher in POCT in comparison to the laboratory (1.627 mmol/L vs. 0.950 mmol/L) has been observed. The agreement in the subjects classification, demonstrates that for glucose, 70% of the subjects show concentrations below the POCT recommended level (5.8-6.1 mmol/L), while 56% are according to the laboratory limit (<5.6 mmol/L). Total cholesterol exhibits a similar trend while POCT triglycerides show a greater percentage of increased values (21% vs. 9%). The reduction in triglycerides bias (phase 2) suggests that differences between POCT and central laboratory is attributable to a pre-analytical problem. The results confirm the acceptable analytical performance of POCT pharmacies and specific criticisms in the pre- and post-analytical phases.

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

Laboratory testing in management of patients with suspected Ebolavirus disease: infection control and safety.

PubMed

Gilbert, G L

2015-08-01

If routine laboratory safety precautions are followed, the risk of laboratory-acquired infection from handling specimens from patients with Ebolavirus disease (EVD) is very low, especially in the early 'dry' stage of disease. In Australia, border screening to identify travellers returning from EVD-affected west African countries during the 2014-2015 outbreak has made it unlikely that specimens from patients with unrecognised EVD would be sent to a routine diagnostic laboratory. Australian public health and diagnostic laboratories associated with hospitals designated for the care of patients with EVD have developed stringent safety precautions for EVD diagnostic and other tests likely to be required for supportive care of the sickest (and most infectious) patients with EVD, including as wide a range of point-of-care tests as possible. However, it is important that the stringent requirements for packaging, transport and testing of specimens that might contain Ebolavirus--which is a tier 1 security sensitive biology agent--do not delay the diagnosis and appropriate management of other potentially serious but treatable infectious diseases, which are far more likely causes of a febrile illness in people returning from west Africa. If necessary, urgent haematology, biochemistry and microbiological tests can be performed safely, whilst awaiting the results of EVD tests, in a PC-2 laboratory with appropriate precautions including: use of recommended personal protective equipment (PPE) for laboratory staff; handling any unsealed specimens in a class 1 or II biosafety cabinet; using only centrifuges with sealed rotors; and safe disposal or decontamination of all used equipment and laboratory waste.

Some new tests at the Gottingen laboratory

NASA Technical Reports Server (NTRS)

1921-01-01

The tests at the Gottingen laboratory included: friction tests on a surface treated with omelette, verification tests on the M.V.A. 356 wing, and comparative tests of wing no. 36 at the Eiffel laboratory. The examination of all these experiments leads to the belief that, at large incidences, the speeds registered by the suction manometer of the testing chamber of the Eiffel laboratory wind tunnel are, owing to pressure drop, greater than the actual speeds. Therefore, the values of k(sub x) and k(sub y) measured at the Eiffel laboratory at large incidences are too low.

Recommended Guidelines for PKU Programs.

ERIC Educational Resources Information Center

Children's Bureau (DHEW), Washington, DC.

A discussion of screening tests for phenylketonuria recommends and provides some data on two tests, lists five disadvantages of urine tests, and discusses three new tests. Also considered are the role of the central laboratory facility and seven suggestions for screening different types of infants at different times. Treatment or followup programs…

[Useful web sites for information about the recommendations of good practices in laboratory medicine].

PubMed

Szymanowicz, A; Watine, J

2010-12-01

In this paper are presented some useful web sites to find updated reference tables concerning the recommendations of professional practices in laboratory medicine. The knowledge of these reference tables can allow the biologist to develop its role of advice to the clinicians. It can also help him to assure a relevant interpretation of the laboratory results and to value the interest for the patient.

Electromedical devices test laboratories accreditation

NASA Astrophysics Data System (ADS)

Murad, C.; Rubio, D.; Ponce, S.; Álvarez Abri, A.; Terrón, A.; Vicencio, D.; Fascioli, E.

2007-11-01

In the last years, the technology and equipment at hospitals have been increase in a great way as the risks of their implementation. Safety in medical equipment must be considered an important issue to protect patients and their users. For this reason, test and calibrations laboratories must verify the correct performance of this kind of devices under national and international standards. Is an essential mission for laboratories to develop their measurement activities taking into account a quality management system. In this article, we intend to transmit our experience working to achieve an accredited Test Laboratories for medical devices in National technological University.

Estrogen and progesterone receptor testing in breast carcinoma: concordance of results between local and reference laboratories in Brazil.

PubMed

Wludarski, Sheila Cristina Lordelo; Lopes, Lisandro Ferreira; Duarte, Ivison Xavier; Carvalho, Filomena Marino; Weiss, Lawrence; Bacchi, Carlos Eduardo

2011-01-01

Breast cancer accounts for approximately one quarter of all cancers in females. Estrogen and progesterone receptor testing has become an essential part of the clinical evaluation of breast carcinoma patients, and accurate results are critical in identifying patients who may benefit from hormone therapy. The present study had the aim of investigating the concordance of the results from hormone receptor tests between a reference laboratory and local (or community) laboratories in Brazil. Retrospective study at a reference pathology laboratory. The concordance in the results from hormone receptor tests between a reference laboratory and 146 local laboratories in Brazil was compared in relation to 500 invasive breast carcinoma cases, using immunohistochemistry. There was concordance in 89.4% (447/500 cases) and 85.0% (425/500 cases) of the results from estrogen (κ = 0.744, P < 0.001) and progesterone (κ = 0.688, P < 0.001) receptor tests, respectively, between local and reference laboratories. This was similar to findings in other countries. The false negative rates from estrogen and progesterone receptor tests in local laboratories were 8.7% and 14.4%, respectively. The false positive rates from estrogen and progesterone receptor tests in local laboratories were 15.5% and 16.0%, respectively. Technical and result interpretation issues may explain most of the discordances in hormone receptor testing in local laboratories. Validation of estrogen and progesterone receptor tests at local laboratories, with rigorous quality control measures, is strongly recommended in order to avoid erroneous treatment of breast cancer patients.

Evaluating performance in sweat testing in medical biochemistry laboratories in Croatia.

PubMed

Aralica, Merica; Krleza, Jasna Lenicek

2017-02-15

Sweat test has a diagnostic role in evaluation of cystic fibrosis. Its performance includes sweat stimulation, collection and analysis. All listed may be sources of inconsistencies in everyday practice. The aim of this study was an evaluation of external quality assessment (EQA) of sweat chloride measurement including sweat test performance in medical biochemistry laboratories in Croatia. EQA for sweat chloride measurement was provided by Croatian Centre for Quality Assessment in Laboratory Medicine (CROQALM) in five consecutive exercises to medical biochemistry laboratories (MBL) that offered sweat testing. A questionnaire regarding all phases of testing was mailed to involved MBL (N = 10). Survey results were compared to current guidelines for sweat test performance. Reported results of EQA in 2015 exercises showed coefficients of variation (CV) from 28.9%, 29.0% to 35.3%, respectively. An introduction of uniform sweat chloride measurement protocol resulted in CV of 15.5% and 14.7% reported in following two exercises in 2016. All MBL included in this study replied to the questionnaire. Results reported by MBL indicated: lack of patient information policy (7/10), use of unacceptable electrodes (6/9), misuse of minimum of acceptable sweat weight (6/9), lack of internal quality assessment (5/9) and recommended reference ranges (5/9 and 4/9). Agreements to guidelines were found in approach to unsuitable patients (9/10) and sweat collection (8/9). Presented results indicate major weak points of current practice in sweat test performance in Croatian MBL and stress the need for its standardization on a national level.

Evaluating performance in sweat testing in medical biochemistry laboratories in Croatia

PubMed Central

Aralica, Merica; Krleza, Jasna Lenicek

2017-01-01

Introduction Sweat test has a diagnostic role in evaluation of cystic fibrosis. Its performance includes sweat stimulation, collection and analysis. All listed may be sources of inconsistencies in everyday practice. The aim of this study was an evaluation of external quality assessment (EQA) of sweat chloride measurement including sweat test performance in medical biochemistry laboratories in Croatia. Materials and methods EQA for sweat chloride measurement was provided by Croatian Centre for Quality Assessment in Laboratory Medicine (CROQALM) in five consecutive exercises to medical biochemistry laboratories (MBL) that offered sweat testing. A questionnaire regarding all phases of testing was mailed to involved MBL (N = 10). Survey results were compared to current guidelines for sweat test performance. Results Reported results of EQA in 2015 exercises showed coefficients of variation (CV) from 28.9%, 29.0% to 35.3%, respectively. An introduction of uniform sweat chloride measurement protocol resulted in CV of 15.5% and 14.7% reported in following two exercises in 2016. All MBL included in this study replied to the questionnaire. Results reported by MBL indicated: lack of patient information policy (7/10), use of unacceptable electrodes (6/9), misuse of minimum of acceptable sweat weight (6/9), lack of internal quality assessment (5/9) and recommended reference ranges (5/9 and 4/9). Agreements to guidelines were found in approach to unsuitable patients (9/10) and sweat collection (8/9). Conclusion Presented results indicate major weak points of current practice in sweat test performance in Croatian MBL and stress the need for its standardization on a national level. PMID:28392735

Misleading biochemical laboratory test results

PubMed Central

Nanji, Amin A.

1984-01-01

This article reviews the general and specific factors that interfere with the performance of common biochemical laboratory tests and the interpretation of their results. The clinical status of the patient, drug interactions, and in-vivo and in-vitro biochemical interactions and changes may alter the results obtained from biochemical analysis of blood constituents. Failure to recognize invalid laboratory test results may lead to injudicious and dangerous management of patients. PMID:6375845

Compliance of clinical microbiology laboratories in the United States with current recommendations for processing respiratory tract specimens from patients with cystic fibrosis.

PubMed

Zhou, Juyan; Garber, Elizabeth; Desai, Manisha; Saiman, Lisa

2006-04-01

Respiratory tract specimens from patients with cystic fibrosis (CF) require unique processing by clinical microbiology laboratories to ensure detection of all potential pathogens. The present study sought to determine the compliance of microbiology laboratories in the United States with recently published recommendations for CF respiratory specimens. Microbiology laboratory protocols from 150 of 190 (79%) CF care sites were reviewed. Most described the use of selective media for Burkholderia cepacia complex (99%), Staphylococcus aureus (82%), and Haemophilus influenzae (89%) and identified the species of all gram-negative bacilli (87%). Only 52% delineated the use of agar diffusion assays for susceptibility testing of Pseudomonas aeruginosa. Standardizing laboratory practices will improve treatment, infection control, and our understanding of the changing epidemiology of CF microbiology.

[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).

Guidelines for safe work practices in human and animal medical diagnostic laboratories. Recommendations of a CDC-convened, Biosafety Blue Ribbon Panel.

PubMed

Miller, J Michael; Astles, Rex; Baszler, Timothy; Chapin, Kimberle; Carey, Roberta; Garcia, Lynne; Gray, Larry; Larone, Davise; Pentella, Michael; Pollock, Anne; Shapiro, Daniel S; Weirich, Elizabeth; Wiedbrauk, Danny

2012-01-06

Prevention of injuries and occupational infections in U.S. laboratories has been a concern for many years. CDC and the National Institutes of Health addressed the topic in their publication Biosafety in Microbiological and Biomedical Laboratories, now in its 5th edition (BMBL-5). BMBL-5, however, was not designed to address the day-to-day operations of diagnostic laboratories in human and animal medicine. In 2008, CDC convened a Blue Ribbon Panel of laboratory representatives from a variety of agencies, laboratory organizations, and facilities to review laboratory biosafety in diagnostic laboratories. The members of this panel recommended that biosafety guidelines be developed to address the unique operational needs of the diagnostic laboratory community and that they be science based and made available broadly. These guidelines promote a culture of safety and include recommendations that supplement BMBL-5 by addressing the unique needs of the diagnostic laboratory. They are not requirements but recommendations that represent current science and sound judgment that can foster a safe working environment for all laboratorians. Throughout these guidelines, quality laboratory science is reinforced by a common-sense approach to biosafety in day-to-day activities. Because many of the same diagnostic techniques are used in human and animal diagnostic laboratories, the text is presented with this in mind. All functions of the human and animal diagnostic laboratory--microbiology, chemistry, hematology, and pathology with autopsy and necropsy guidance--are addressed. A specific section for veterinary diagnostic laboratories addresses the veterinary issues not shared by other human laboratory departments. Recommendations for all laboratories include use of Class IIA2 biological safety cabinets that are inspected annually; frequent hand washing; use of appropriate disinfectants, including 1:10 dilutions of household bleach; dependence on risk assessments for many activities

Structural Test Laboratory | Water Power | NREL

Science.gov Websites

Structural Test Laboratory Structural Test Laboratory NREL engineers design and configure structural components can validate models, demonstrate system reliability, inform design margins, and assess , including mass and center of gravity, to ensure compliance with design goals Dynamic Characterization Use

49 CFR 199.107 - Drug testing laboratory.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 3 2012-10-01 2012-10-01 false Drug testing laboratory. 199.107 Section 199.107... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY DRUG AND ALCOHOL TESTING Drug Testing § 199.107 Drug testing laboratory. (a) Each operator shall use for the drug testing required by this...

49 CFR 199.107 - Drug testing laboratory.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 3 2011-10-01 2011-10-01 false Drug testing laboratory. 199.107 Section 199.107... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY DRUG AND ALCOHOL TESTING Drug Testing § 199.107 Drug testing laboratory. (a) Each operator shall use for the drug testing required by this...

49 CFR 199.107 - Drug testing laboratory.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 3 2010-10-01 2010-10-01 false Drug testing laboratory. 199.107 Section 199.107... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY DRUG AND ALCOHOL TESTING Drug Testing § 199.107 Drug testing laboratory. (a) Each operator shall use for the drug testing required by this...

49 CFR 199.107 - Drug testing laboratory.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 3 2013-10-01 2013-10-01 false Drug testing laboratory. 199.107 Section 199.107... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY DRUG AND ALCOHOL TESTING Drug Testing § 199.107 Drug testing laboratory. (a) Each operator shall use for the drug testing required by this...

49 CFR 199.107 - Drug testing laboratory.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 3 2014-10-01 2014-10-01 false Drug testing laboratory. 199.107 Section 199.107... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY DRUG AND ALCOHOL TESTING Drug Testing § 199.107 Drug testing laboratory. (a) Each operator shall use for the drug testing required by this...

Recommendations for provoked challenge urine testing.

PubMed

Ruha, Anne-Michelle

2013-12-01

"Urine mobilization test," "challenge test," and "provoked urine test" are all terms used to describe the administration of a chelating agent to a person prior to collection of their urine to test for metals. There is no standard, validated challenge test. Despite recommendations by professional and government organizations against the use of provoked urine testing, the tests are still commonly used and recommended by some practitioners. Challenge testing utilizes a variety of chelating agents, including dimercaptosuccinic acid (DMSA), dimercaptopropanesulfonate (DMPS), and ethylenediaminetetraacetic acid (EDTA). The agents are given by a variety of routes of administration, doses used are inconsistent, and urine collection procedures vary. Additional problems with challenge tests include comparison of results to inappropriate reference ranges and creatinine correction of urine obtained within hours of chelator administration. Human volunteer studies demonstrate that mercury is detected in the urine of most people even in the absence of known exposure or chelator administration, and that urinary mercury excretion rises after administration of a chelator, regardless of exposure history and in an unpredictable fashion. Studies also demonstrate that challenge testing fails to reveal a "body burden" of mercury due to remote exposure. Chelating agents have been associated with adverse reactions. Current evidence does not support the use of DMPS, DMSA, or other chelation challenge tests for the diagnosis of metal toxicity. Since there are no established reference ranges for provoked urine samples in healthy subjects, no reliable evidence to support a diagnostic value for the tests, and potential harm, these tests should not be utilized.

Do laboratories follow heart failure recommendations and guidelines and did we improve? The CARdiac MArker Guideline Uptake in Europe (CARMAGUE).

PubMed

Hammerer-Lercher, Angelika; Collinson, Paul; van Dieijen-Visser, Marja P; Pulkki, Kari; Suvisaari, Janne; Ravkilde, Jan; Stavljenic-Rukavina, Ana; Baum, Hannsjörg; Laitinen, Päivi

2013-06-01

Natriuretic peptides (NP) are well-established markers of heart failure (HF). During the past 5 years, analytical and clinical recommendations for measurement of these biomarkers have been published in guidelines. The aim of this follow-up survey was to investigate how well these guidelines for measurement of NP have been implemented in laboratory practice in Europe. Member societies of the European Federation of Clinical Chemistry and Laboratory Medicine were invited in 2009 to participate in a web-based audit questionnaire. The questionnaire requested information on type of tests performed, decision limits for HF, turn-around time and frequency of testing. There was a moderate increase (12%) of laboratories measuring NP compared to the initial survey in 2006. The most frequently used HF decision limits for B-type NP (BNP) and N-terminal BNP (NT-proBNP) were, respectively, 100 ng/L and 125 ng/L, derived from the package inserts in 55%. Fifty laboratories used a second decision limit. Age or gender dependent decision limits were applied in 10% (8.5% in 2006). The vast majority of laboratories (80%) did not have any criteria regarding frequency of testing, compared to 33% in 2006. The implementation of NP measurement for HF management was a slow process between 2006 and 2009 at a time when guidelines had just been established. The decision limits were derived from package insert information and literature. There was great uncertainty concerning frequency of testing which may reflect the debate about the biological variability which was not published for most of the assays in 2009.

Human Papillomavirus Laboratory Testing: the Changing Paradigm

PubMed Central

2016-01-01

SUMMARY High-risk human papillomaviruses (HPVs) cause essentially all cervical cancers, most anal and oropharyngeal cancers, and some vaginal, vulvar, and penile cancers. Improved understanding of the pathogenesis of infection and the availability of newer tests are changing the approach to screening and diagnosis. Molecular tests to detect DNA from the most common high-risk HPVs are FDA approved for use in conjunction with cytology in cervical cancer screening programs. More-specific tests that detect RNA from high-risk HPV types are now also available. The use of molecular tests as the primary screening tests is being adopted in some areas. Genotyping to identify HPV16 and -18 has a recommended role in triaging patients for colposcopy who are high-risk HPV positive but have normal cytology. There are currently no recommended screening methods for anal, vulvar, vaginal, penile, or oropharyngeal HPV infections. HPV testing has limited utility in patients at high risk for anal cancer, but p16 immunohistochemistry is recommended to clarify lesions in tissue biopsy specimens that show moderate dysplasia or precancer mimics. HPV testing is recommended for oropharyngeal squamous cell tumors as a prognostic indicator. Ongoing research will help to improve the content of future guidelines for screening and diagnostic testing. PMID:26912568

Fuel Cell Development and Test Laboratory | Energy Systems Integration

Science.gov Websites

Facility | NREL Fuel Cell Development and Test Laboratory Fuel Cell Development and Test Laboratory The Energy System Integration Facility's Fuel Cell Development and Test Laboratory supports fuel a fuel cell test in the Fuel Cell Development and Test Laboratory. Capability Hubs The Fuel Cell

Errors in the Extra-Analytical Phases of Clinical Chemistry Laboratory Testing.

PubMed

Zemlin, Annalise E

2018-04-01

The total testing process consists of various phases from the pre-preanalytical to the post-postanalytical phase, the so-called brain-to-brain loop. With improvements in analytical techniques and efficient quality control programmes, most laboratory errors now occur in the extra-analytical phases. There has been recent interest in these errors with numerous publications highlighting their effect on service delivery, patient care and cost. This interest has led to the formation of various working groups whose mission is to develop standardized quality indicators which can be used to measure the performance of service of these phases. This will eventually lead to the development of external quality assessment schemes to monitor these phases in agreement with ISO15189:2012 recommendations. This review focuses on potential errors in the extra-analytical phases of clinical chemistry laboratory testing, some of the studies performed to assess the severity and impact of these errors and processes that are in place to address these errors. The aim of this review is to highlight the importance of these errors for the requesting clinician.

[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).

19 CFR 151.54 - Testing by Customs laboratory.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 19 Customs Duties 2 2010-04-01 2010-04-01 false Testing by Customs laboratory. 151.54 Section 151... Other Metal-Bearing Materials § 151.54 Testing by Customs laboratory. Samples taken in accordance with § 151.52 shall be promptly forwarded to the appropriate Customs laboratory for testing in accordance...

How Reliable Is Laboratory Testing?

MedlinePlus

... laboratory testing. (See Who's Who in the Lab .) Post-Analytic Activities After the test is completed, the result must be delivered in ... View Sources NOTE: This article is based on research that ... of the Lab Tests Online Editorial Review Board . This article is periodically ...

External quality assessment for laboratory testing of HLA-B*15:02 allele in relation to carbamazepine therapy.

PubMed

Lin, Guigao; Zhang, Kuo; Han, Yanxi; Xie, Jiehong; Li, Jinming

2018-02-01

Due to the significant risk of developing Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), the use of carbamazepine is not recommended in patients carrying the human leukocyte antigen B (HLA-B) *15:02 allele. In an effort to guarantee reliable community-based HLA-B*15:02 testing throughout China, a HLA-B*15:02 genotyping external quality assessment (EQA) program was set up. In 2016, 10 genomic DNA samples with known HLA-B*15:02 allele status were sent to 37 laboratories from 16 provinces with a request for routine HLA-B*15:02 screening. The samples were validated using Sanger sequencing by a reference laboratory. Both genotyping results and clinical written reports were evaluated. Thirty-six of the participating laboratories correctly identified the HLA-B*15:02 allele status for all EQA samples. However, one lab failed to identify any positive challenges. The overall analytical sensitivity was 97.3% (180/185 challenges; 95% confidence interval: 93.8%-99.1%) and the analytic specificity was 100% (185/185; 95% confidence interval: 98.0%-100%). A review of the written reports showed that the clinical reporting for HLA-B*15:02 detection should be improved. Some essential information was missing, most notably laboratory information/contact, therapeutic recommendations, and methodology. External quality assessment is valuable in assessing and improving the quality of laboratory testing of HLA-B*15:02 allele. © 2017 Wiley Periodicals, Inc.

Mars Science Laboratory Spacecraft Assembled for Testing

NASA Technical Reports Server (NTRS)

2008-01-01

The major components of NASA's Mars Science Laboratory spacecraft cruise stage atop the aeroshell, which has the descent stage and rover inside were connected together in October 2008 for several weeks of system testing, including simulation of launch vibrations and deep-space environmental conditions.

These components will be taken apart again, for further work on each of them, after the environmental testing. The Mars Science Laboratory spacecraft is being assembled and tested for launch in 2011.

This image was taken inside the Spacecraft Assembly Facility at NASA's Jet Propulsion Laboratory, Pasadena, Calif., which manages the Mars Science Laboratory Project for the NASA Science Mission Directorate, Washington. JPL is a division of the California Institute of Technology.

Good Practice Recommendations in the Field of Heating, Ventilation, and Air Conditioning for Health Related Research Laboratories.

ERIC Educational Resources Information Center

Laboratory Design Notes, 1966

1966-01-01

A collection of laboratory design notes to set forth minimum criteria required in the design of basic medical research laboratory buildings. Recommendations contained are primarily concerned with features of design which affect quality of performance and future flexibility of facility systems. Subjects of economy and safety are discussed where…

Recommendations for the design of laboratory studies on non-target arthropods for risk assessment of genetically engineered plants

PubMed Central

Hellmich, Richard L.; Candolfi, Marco P.; Carstens, Keri; De Schrijver, Adinda; Gatehouse, Angharad M. R.; Herman, Rod A.; Huesing, Joseph E.; McLean, Morven A.; Raybould, Alan; Shelton, Anthony M.; Waggoner, Annabel

2010-01-01

This paper provides recommendations on experimental design for early-tier laboratory studies used in risk assessments to evaluate potential adverse impacts of arthropod-resistant genetically engineered (GE) plants on non-target arthropods (NTAs). While we rely heavily on the currently used proteins from Bacillus thuringiensis (Bt) in this discussion, the concepts apply to other arthropod-active proteins. A risk may exist if the newly acquired trait of the GE plant has adverse effects on NTAs when they are exposed to the arthropod-active protein. Typically, the risk assessment follows a tiered approach that starts with laboratory studies under worst-case exposure conditions; such studies have a high ability to detect adverse effects on non-target species. Clear guidance on how such data are produced in laboratory studies assists the product developers and risk assessors. The studies should be reproducible and test clearly defined risk hypotheses. These properties contribute to the robustness of, and confidence in, environmental risk assessments for GE plants. Data from NTA studies, collected during the analysis phase of an environmental risk assessment, are critical to the outcome of the assessment and ultimately the decision taken by regulatory authorities on the release of a GE plant. Confidence in the results of early-tier laboratory studies is a precondition for the acceptance of data across regulatory jurisdictions and should encourage agencies to share useful information and thus avoid redundant testing. PMID:20938806

Grid Modernization Laboratory Consortium - Testing and Verification

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

Kroposki, Benjamin; Skare, Paul; Pratt, Rob

This paper highlights some of the unique testing capabilities and projects being performed at several national laboratories as part of the U. S. Department of Energy Grid Modernization Laboratory Consortium. As part of this effort, the Grid Modernization Laboratory Consortium Testing Network isbeing developed to accelerate grid modernization by enablingaccess to a comprehensive testing infrastructure and creating a repository of validated models and simulation tools that will be publicly available. This work is key to accelerating thedevelopment, validation, standardization, adoption, and deployment of new grid technologies to help meet U. S. energy goals.

Outsourcing cytological samples to a referral laboratory for EGFR testing in non-small cell lung cancer: does theory meet practice?

PubMed

Vigliar, E; Malapelle, U; Bellevicine, C; de Luca, C; Troncone, G

2015-10-01

Guidelines from the College of American Pathologists (CAP), the International Association for the Study of Lung Cancer (IASLC) and the Association for Molecular Pathology (AMP) consider cytology suitable for testing epidermal growth factor receptor (EGFR) mutations in lung adenocarcinoma. The guidelines recommend that cytopathologists first discuss the possibility of testing squamous cell carcinomas (SqCC) in multidisciplinary meetings. Second, cell blocks should be analysed rather than smear preparations and, third, specimens should be sent to external molecular laboratories within three working days of receiving requests. This study monitored how these recommendations are met in practice. Our laboratory received 596 requests from cytologists from 13 different institutions. For each case, the cytological diagnosis, cytopreparation type, and time between the request and sample mailing were compared with the recommendations. Of the 596 samples, 32 (5.4%) had been reported as SqCC. Three of these (9.4%) showed EGFR mutation. Cytological slides, either ThinPrep(™) (51.2%) or direct smears (43.2%), were more frequently received than cell blocks (5.7%). The mean time between the oncologist's request and specimen dispatching was 5.8 working days. The occurrence of mutations in samples reported as SqCC was higher than expected. This questions the reliability of the original diagnosis, which reinforced the recommendation to evaluate the opportunity for testing non-adenocarcinoma cytology on a case-by-case basis. In spite of CAP/IASLC/AMP recommendations, cell blocks were underutilized for EGFR testing, but cytological slides were suitable for DNA analyses. Significant efforts are needed to avoid delays in outsourcing cytological samples for EGFR testing. © 2014 John Wiley & Sons Ltd.

[Economic impact of external laboratory test].

PubMed

Takura, Tomoyuki

2006-11-01

The realities of the spread and the aim of the introduction, and an economical influence of an external laboratory tests were researched. As a result, 90% or more the ratio to have consigned the external whole became clear. But it is preferable to correspond about inspection item of about 70% in own facilities because of the characteristic of the medical institution and the inspection item. Moreover, when correct the unbridgeable gulf of characteristic of the realities of spread of present external laboratory tests inspection and the ranging of ideal external laboratory tests inspection that specialist thinks about, the needed medical payment was thought that the investment of about 50 billion yen a year was necessary to expand the inspection in own facilities, by calculated based on the stochastic model.

Advanced Multi-Axis Spine Testing: Clinical Relevance and Research Recommendations

PubMed Central

Holsgrove, Timothy P.; Nayak, Nikhil R.; Welch, William C.

2015-01-01

Back pain and spinal degeneration affect a large proportion of the general population. The economic burden of spinal degeneration is significant, and the treatment of spinal degeneration represents a large proportion of healthcare costs. However, spinal surgery does not always provide improved clinical outcomes compared to non-surgical alternatives, and modern interventions, such as total disc replacement, may not offer clinically relevant improvements over more established procedures. Although psychological and socioeconomic factors play an important role in the development and response to back pain, the variation in clinical success is also related to the complexity of the spine, and the multi-faceted manner by which spinal degeneration often occurs. The successful surgical treatment of degenerative spinal conditions requires collaboration between surgeons, engineers, and scientists in order to provide a multi-disciplinary approach to managing the complete condition. In this review, we provide relevant background from both the clinical and the basic research perspectives, which is synthesized into several examples and recommendations for consideration in increasing translational research between communities with the goal of providing improved knowledge and care. Current clinical imaging, and multi-axis testing machines, offer great promise for future research by combining invivo kinematics and loading with in-vitro testing in six degrees of freedom to offer more accurate predictions of the performance of new spinal instrumentation. Upon synthesis of the literature, it is recommended that in-vitro tests strive to recreate as many aspects of the in-vivo environment as possible, and that a physiological preload is a critical factor in assessing spinal biomechanics in the laboratory. A greater link between surgical procedures, and the outcomes in all three anatomical planes should be considered in both the in-vivo and in-vitro settings, to provide data relevant to

Battery testing at Argonne National Laboratory

NASA Astrophysics Data System (ADS)

Deluca, W. H.; Gillie, K. R.; Kulaga, J. E.; Smaga, J. A.; Tummillo, A. F.; Webster, C. E.

1993-03-01

Argonne National Laboratory's Analysis & Diagnostic Laboratory (ADL) tests advanced batteries under simulated electric and hybrid vehicle operating conditions. The ADL facilities also include a post-test analysis laboratory to determine, in a protected atmosphere if needed, component compositional changes and failure mechanisms. The ADL provides a common basis for battery performance characterization and life evaluations with unbiased application of tests and analyses. The battery evaluations and post-test examinations help identify factors that limit system performance and life and the most-promising R&D approaches for overcoming these limitations. Since 1991, performance characterizations and/or life evaluations have been conducted on eight battery technologies: Na/S, Li/S, Zn/Br, Ni/MH, Ni/Zn, Ni/Cd, Ni/Fe, and lead-acid. These evaluations were performed for the Department of Energy's. Office of Transportation Technologies, Electric and Hybrid Propulsion Division (DOE/OTT/EHP), and Electric Power Research Institute (EPRI) Transportation Program. The results obtained are discussed.

Evaluation of Mycology Laboratory Proficiency Testing

PubMed Central

Reilly, Andrew A.; Salkin, Ira F.; McGinnis, Michael R.; Gromadzki, Sally; Pasarell, Lester; Kemna, Maggi; Higgins, Nancy; Salfinger, Max

1999-01-01

Changes over the last decade in overt proficiency testing (OPT) regulations have been ostensibly directed at improving laboratory performance on patient samples. However, the overt (unblinded) format of the tests and regulatory penalties associated with incorrect values allow and encourage laboratorians to take extra precautions with OPT analytes. As a result OPT may measure optimal laboratory performance instead of the intended target of typical performance attained during routine patient testing. This study addresses this issue by evaluating medical mycology OPT and comparing its fungal specimen identification error rates to those obtained in a covert (blinded) proficiency testing (CPT) program. Identifications from 188 laboratories participating in the New York State mycology OPT from 1982 to 1994 were compared with the identifications of the same fungi recovered from patient specimens in 1989 and 1994 as part of the routine procedures of 88 of these laboratories. The consistency in the identification of OPT specimens was sufficient to make accurate predictions of OPT error rates. However, while the error rates in OPT and CPT were similar for Candida albicans, significantly higher error rates were found in CPT for Candida tropicalis, Candida glabrata, and other common pathogenic fungi. These differences may, in part, be due to OPT’s use of ideal organism representatives cultured under optimum growth conditions. This difference, as well as the organism-dependent error rate differences, reflects the limitations of OPT as a means of assessing the quality of routine laboratory performance in medical mycology. PMID:10364601

42 CFR 493.1441 - Condition: Laboratories performing high complexity testing; laboratory director.

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; laboratory director. 493.1441 Section 493.1441 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY...

42 CFR 493.1441 - Condition: Laboratories performing high complexity testing; laboratory director.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Condition: Laboratories performing high complexity testing; laboratory director. 493.1441 Section 493.1441 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY...

First proficiency testing to evaluate the ability of European Union National Reference Laboratories to detect staphylococcal enterotoxins in milk products.

PubMed

Hennekinne, Jacques-Antoine; Gohier, Martine; Maire, Tiphaine; Lapeyre, Christiane; Lombard, Bertrand; Dragacci, Sylviane

2003-01-01

The European Commission has designed a network of European Union-National Reference Laboratories (EU-NRLs), coordinated by a Community Reference Laboratory (CRL), for control of hygiene of milk and milk products (Council Directive 92/46/ECC). As a common contaminant of milk and milk products such as cheese, staphylococcal enterotoxins are often involved in human outbreaks and should be monitored regularly. The main tasks of the EU-CRLs were to select and transfer to the EU-NRLs a reference method for detection of enterotoxins, and to set up proficiency testing to evaluate the competency of the European laboratory network. The first interlaboratory exercise was performed on samples of freeze-dried cheese inoculated with 2 levels of staphylococcal enterotoxins (0.1 and 0.25 ng/g) and on an uninoculated control. These levels were chosen considering the EU regulation for staphylococcal enterotoxins in milk and milk products and the limit of detection of the enzyme-linked immunosorbent assay test recommended in the reference method. The trial was conducted according to the recommendations of ISO Guide 43. Results produced by laboratories were compiled and compared through statistical analysis. Except for data from 2 laboratories for the uninoculated control and cheese inoculated at 0.1 ng/g, all laboratories produced satisfactory results, showing the ability of the EU-NRL network to monitor the enterotoxin contaminant.

Energy Systems High-Pressure Test Laboratory | Energy Systems Integration

Science.gov Websites

Facility | NREL Energy Systems High-Pressure Test Laboratory Energy Systems High-Pressure Test Laboratory In the Energy Systems Integration Facility's High-Pressure Test Laboratory, researchers can safely test high-pressure hydrogen components. Photo of researchers running an experiment with a hydrogen fuel

Testing activities at the National Battery Test Laboratory

NASA Astrophysics Data System (ADS)

Hornstra, F.; Deluca, W. H.; Mulcahey, T. P.

The National Battery Test Laboratory (NBTL) is an Argonne National Laboratory facility for testing, evaluating, and studying advanced electric storage batteries. The facility tests batteries developed under Department of Energy programs and from private industry. These include batteries intended for future electric vehicle (EV) propulsion, electric utility load leveling (LL), and solar energy storage. Since becoming operational, the NBTL has evaluated well over 1400 cells (generally in the form of three- to six-cell modules, but up to 140-cell batteries) of various technologies. Performance characterization assessments are conducted under a series of charge/discharge cycles with constant current, constant power, peak power, and computer simulated dynamic load profile conditions. Flexible charging algorithms are provided to accommodate the specific needs of each battery under test. Special studies are conducted to explore and optimize charge procedures, to investigate the impact of unique load demands on battery performance, and to analyze the thermal management requirements of battery systems.

Clinical utility of routine laboratory testing to identify possible secondary causes in older men with osteoporosis: the Osteoporotic Fractures in Men (MrOS) Study

PubMed Central

Fink, Howard A.; Litwack-Harrison, Stephanie; Taylor, Brent C.; Bauer, Douglas C.; Orwoll, Eric S.; Lee, Christine G.; Barrett-Connor, Elizabeth; Schousboe, John T.; Kado, Deborah M.; Garimella, Pranav S.; Ensrud, Kristine E.

2016-01-01

Purpose To evaluate the utility of recommended laboratory testing to identify secondary causes in older men with osteoporosis, we examined prevalence of laboratory abnormalities in older men with and without osteoporosis. Methods 1572 men aged ≥65 years in the Osteoporotic Fractures in Men study completed bone mineral density (BMD) testing and a battery of laboratory measures, including serum calcium, phosphorus, alkaline phosphatase, parathyroid hormone (PTH), thyroid-stimulating hormone (TSH), 25-OH vitamin D, total testosterone, spot urine calcium/creatinine ratio, spot urine albumin-creatinine ratio, creatinine-derived estimate glomerular filtration rate, 24-hour urine calcium, and 24-hour urine free cortisol. Using cross-sectional analyses, we calculated prevalence ratios (PR) and 95% confidence intervals (CI) for the association of any and specific laboratory abnormalities with osteoporosis, and the number of men with osteoporosis needed to test to identify one additional laboratory abnormality compared to testing men without osteoporosis. Results Approximately 60% of men had ≥1 laboratory abnormality in both men with and without osteoporosis. Among individual tests, only vitamin D insufficiency (PR, 1.13; 95% CI, 1.05–1.22) and high alkaline phosphatase (PR, 3.05; 95% CI, 1.52–6.11) were more likely in men with osteoporosis. Hypercortisolism and hyperthyroidism were uncommon and not significantly more frequent in men with osteoporosis. No osteoporotic men had hypercalciuria. Conclusions Though most of these older men had ≥1 laboratory abnormality, few routinely recommended individual tests were more common in men with osteoporosis than in those without osteoporosis. Possibly excepting vitamin D and alkaline phosphatase, benefit of routine laboratory testing to identify possible secondary causes in older osteoporotic men appears low. Results may not be generalizable to younger men or to older men in whom history and exam findings raise clinical

Primer Stepper Motor Nomenclature, Definition, Performance and Recommended Test Methods

NASA Technical Reports Server (NTRS)

Starin, Scott; Shea, Cutter

2014-01-01

There has been an unfortunate lack of standardization of the terms and components of stepper motor performance, requirements definition, application of torque margin and implementation of test methods. This paper will address these inconsistencies and discuss in detail the implications of performance parameters, affects of load inertia, control electronics, operational resonances and recommended test methods. Additionally, this paper will recommend parameters for defining and specifying stepper motor actuators. A useful description of terms as well as consolidated equations and recommended requirements is included.

49 CFR 40.85 - What drugs do laboratories test for?

Code of Federal Regulations, 2013 CFR

2013-10-01

... WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.85 What drugs do laboratories test for? As a laboratory, you must test for the following five drugs or classes of drugs in a DOT drug... 49 Transportation 1 2013-10-01 2013-10-01 false What drugs do laboratories test for? 40.85 Section...

49 CFR 40.85 - What drugs do laboratories test for?

Code of Federal Regulations, 2014 CFR

2014-10-01

... WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.85 What drugs do laboratories test for? As a laboratory, you must test for the following five drugs or classes of drugs in a DOT drug... 49 Transportation 1 2014-10-01 2014-10-01 false What drugs do laboratories test for? 40.85 Section...

49 CFR 40.85 - What drugs do laboratories test for?

Code of Federal Regulations, 2011 CFR

2011-10-01

... WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.85 What drugs do laboratories test for? As a laboratory, you must test for the following five drugs or classes of drugs in a DOT drug... 49 Transportation 1 2011-10-01 2011-10-01 false What drugs do laboratories test for? 40.85 Section...

49 CFR 40.85 - What drugs do laboratories test for?

Code of Federal Regulations, 2012 CFR

2012-10-01

... WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.85 What drugs do laboratories test for? As a laboratory, you must test for the following five drugs or classes of drugs in a DOT drug... 49 Transportation 1 2012-10-01 2012-10-01 false What drugs do laboratories test for? 40.85 Section...

49 CFR 40.85 - What drugs do laboratories test for?

Code of Federal Regulations, 2010 CFR

2010-10-01

... WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.85 What drugs do laboratories test for? As a laboratory, you must test for the following five drugs or classes of drugs in a DOT drug... 49 Transportation 1 2010-10-01 2010-10-01 false What drugs do laboratories test for? 40.85 Section...

10 CFR 431.18 - Testing laboratories.

Code of Federal Regulations, 2010 CFR

2010-01-01

... EQUIPMENT Electric Motors Test Procedures, Materials Incorporated and Methods of Determining Efficiency... Technology/National Voluntary Laboratory Accreditation Program (NIST/NVLAP); or (2) A laboratory... of the National Institute of Standards and Technology (NIST) which is part of the U.S. Department of...

Laboratory testing under managed care dominance in the USA

PubMed Central

Takemura, Y; Beck, J

2001-01-01

The uncontrolled escalation of total health care expenditure despite the government's endeavours during the past decades in the USA had led to the rapid infiltration of managed care organisations (MCOs). Traditional hospital based laboratories have been placed in a crucial situation with the advent of the managed care era. A massive reduction of in house testing urged them to develop strategies against financial difficulty. Consolidation and networking, participation in the outreach testing market, and emphasis on point of care/satellite laboratory testing in non-traditional, ambulatory settings are major strategies for the survival of hospital laboratories. Several physicians' office laboratories (POLS) have closed their doors in response both to regulatory restrictions imposed by the Clinical Laboratory Improvement Amendments of 1988 and to managed care infiltration. It seems likely that POLs and hospital laboratories will continue to reduce test volumes, whereas commercial reference laboratories will thrive through contracting with MCOs. In the current climate of managed care dominance in the USA, clinical laboratories are changing their basic operation focus and mission in response to the aggressively changing landscape. Key Words: laboratory testing • managed care organisations • survival strategies PMID:11215291

Lipid and lipoprotein testing in resource-limited laboratories.

PubMed

Myers, Gary L

2003-01-01

The role of total cholesterol (TC) and lipoproteins in the assessment of coronary heart disease (CHD) is firmly established from population and intervention studies. Total and low-density lipoprotein cholesterol (LDLC) levels are positively associated with CHD, and high-density lipoprotein cholesterol (HDLC) levels are negatively associated with CHD. Efforts to identify and treat people at increased risk based on cholesterol and lipoprotein levels have led to more lipid testing and the need for very reliable test results. Thus, quality laboratory services are an essential component of healthcare delivery and play a vital role in any strategy to reduce morbidity and mortality from CHD. In laboratories with limited resources, establishing laboratory capability to measure CHD risk markers may be a considerable challenge. Laboratories face problems in selecting proper techniques, difficulties in equipment availability and maintenance, and shortage of supplies, staffing, and supervision. The Centers for Disease Control and Prevention (CDC) has been providing technical assistance for more than 30 years to laboratories that measure lipids and lipoproteins and is willing to provide technical assistance as needed for other laboratories to develop this capability. CDC can provide technical assistance to establish lipid and lipoprotein testing capability to support a CHD public health program in areas with limited laboratory resources. This assistance includes: selecting a suitable testing instrument; providing training for laboratory technicians; establishing a simple quality control plan; and instructing staff on how to prepare frozen serum control materials suitable for assessing accuracy of lipid and lipoprotein testing.

Managing demand for laboratory tests: a laboratory toolkit.

PubMed

Fryer, Anthony A; Smellie, W Stuart A

2013-01-01

Healthcare budgets worldwide are facing increasing pressure to reduce costs and improve efficiency, while maintaining quality. Laboratory testing has not escaped this pressure, particularly since pathology investigations cost the National Health Service £2.5 billion per year. Indeed, the Carter Review, a UK Department of Health-commissioned review of pathology services in England, estimated that 20% of this could be saved by improving pathology services, despite an average annual increase of 8%-10% in workload. One area of increasing importance is managing the demands for pathology tests and reducing inappropriate requesting. The Carter Review estimated that 25% of pathology tests were unnecessary, representing a huge potential waste. Certainly, the large variability in levels of requesting between general practitioners suggests that inappropriate requesting is widespread. Unlocking the key to this variation and implementing measures to reduce inappropriate requesting would have major implications for patients and healthcare resources alike. This article reviews the approaches to demand management. Specifically, it aims to (a) define demand management and inappropriate requesting, (b) assess the drivers for demand management, (c) examine the various approaches used, illustrating the potential of electronic requesting and (d) provide a wider context. It will cover issues, such as educational approaches, information technology opportunities and challenges, vetting, duplicate request identification and management, the role of key performance indicators, profile composition and assessment of downstream impact of inappropriate requesting. Currently, many laboratories are exploring demand management using a plethora of disparate approaches. Hence, this review seeks to provide a 'toolkit' with the view to allowing laboratories to develop a standardised demand management strategy.

Laboratory Diagnostics Market in East Africa: A Survey of Test Types, Test Availability, and Test Prices in Kampala, Uganda.

PubMed

Schroeder, Lee F; Elbireer, Ali; Jackson, J Brooks; Amukele, Timothy K

2015-01-01

Diagnostic laboratory tests are routinely defined in terms of their sensitivity, specificity, and ease of use. But the actual clinical impact of a diagnostic test also depends on its availability and price. This is especially true in resource-limited settings such as sub-Saharan Africa. We present a first-of-its-kind report of diagnostic test types, availability, and prices in Kampala, Uganda. Test types (identity) and availability were based on menus and volumes obtained from clinical laboratories in late 2011 in Kampala using a standard questionnaire. As a measure of test availability, we used the Availability Index (AI). AI is the combined daily testing volumes of laboratories offering a given test, divided by the combined daily testing volumes of all laboratories in Kampala. Test prices were based on a sampling of prices collected in person and via telephone surveys in 2015. Test volumes and menus were obtained for 95% (907/954) of laboratories in Kampala city. These 907 laboratories offered 100 different test types. The ten most commonly offered tests in decreasing order were Malaria, HCG, HIV serology, Syphilis, Typhoid, Urinalysis, Brucellosis, Stool Analysis, Glucose, and ABO/Rh. In terms of AI, the 100 tests clustered into three groups: high (12 tests), moderate (33 tests), and minimal (55 tests) availability. 50% and 36% of overall availability was provided through private and public laboratories, respectively. Point-of-care laboratories contributed 35% to the AI of high availability tests, but only 6% to the AI of the other tests. The mean price of the most commonly offered test types was $2.62 (range $1.83-$3.46). One hundred different laboratory test types were in use in Kampala in late 2011. Both public and private laboratories were critical to test availability. The tests offered in point-of-care laboratories tended to be the most available tests. Prices of the most common tests ranged from $1.83-$3.46.

7 CFR 75.43 - Laboratory testing.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 3 2011-01-01 2011-01-01 false Laboratory testing. 75.43 Section 75.43 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards... AND CERTIFICATION OF QUALITY OF AGRICULTURAL AND VEGETABLE SEEDS Fees and Charges § 75.43 Laboratory...

7 CFR 75.43 - Laboratory testing.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 3 2010-01-01 2010-01-01 false Laboratory testing. 75.43 Section 75.43 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards... AND CERTIFICATION OF QUALITY OF AGRICULTURAL AND VEGETABLE SEEDS Fees and Charges § 75.43 Laboratory...

Physical examination instead of laboratory tests for most infants born to mothers colonized with group B Streptococcus: support for the Centers for Disease Control and Prevention's 2010 recommendations.

PubMed

Cantoni, Luigi; Ronfani, Luca; Da Riol, Rosalia; Demarini, Sergio

2013-08-01

To compare 2 approaches in the management of neonates at risk for group B Streptococcus early-onset sepsis: laboratory tests plus standardized physical examination and standardized physical examination alone. Prospective, sequential study over 2 consecutive 12-month periods, carried out in the maternity hospitals of the region Friuli-Venezia Giulia (north-eastern Italy). All term infants were included (7628 in the first period, 7611 in the second). In the first period, complete blood count and blood culture were required for all infants at risk, followed by a 48-hour period of observation with a standardized physical examination. In the second period, only standardized physical examination was performed. Study outcomes were: (1) number of neonates treated with antibiotics; and (2) time between onset of signs of possible sepsis and beginning of treatment. There was no difference between the 2 periods in the rate of maternal colonization (19.7% vs 19.8%, P = .8), or in other risk factors. The interval between onset of signs of sepsis and starting of antibiotics was not different in the 2 periods. Significantly fewer infants were treated with antibiotics in the second period (0.5% vs 1.2%, P < .001). Laboratory tests together with standardized physical examination seem to offer no advantage over standardized physical examination alone; the latter was associated with fewer antibiotic treatments. Our results are in agreement with the Center for Disease Control and Prevention's 2010 recommendations. Copyright © 2013 Mosby, Inc. All rights reserved.

Recommendation for a non-animal alternative to rat caries testing.

PubMed

Featherstone, John D B; Stookey, George K; Kaminski, Michael A; Faller, Robert V

2011-10-01

than 50 years, fluoride has been the first defense in the fight against dental caries. The clinical effectiveness of fluoride is well accepted and documented extensively in the literature. The mechanism through which fluoride provides its benefit is very straightforward and well understood. The proposed laboratory model effectively simulates the effect of the caries process and has been shown to demonstrate equivalent accuracy to animal caries. This indicates that there are strong scientific grounds for the use of this model as an alternative to the animal caries test. Based on the strength of the data and the correlations noted between the two models, we recommend that the scientific community and the toothpaste industry broadly accept the Featherstone laboratory pH cycling model as an appropriate alternative to animal testing, particularly for ionic fluoride based dentifrices.

Cleaning Aged EPDM Rubber Roofing Membrane Material for Patching: Laboratory Investigations and Recommendations

DTIC Science & Technology

1992-08-01

Cleaning Aged EPDM Rubber Roofing Membrane Material for Patching: Laboratory Investigations and Recommendations Walter J. Rossiter, Jr. T N n-’T ic...condition of the aged EPDM rubber before bonding. This study assessed the effectiveness of different cleaning methods for preparing aged EPDM membranes for...REPORT DATE 3. REPORT TYPE AND DATES COVERED August 1992 Final 4. TITLE AND SUBTITLE 5. FUNDING NUMBERS Cleaning Aged EPDM Rubber Roofing Membrane

Managing laboratory test ordering through test frequency filtering.

PubMed

Janssens, Pim M W; Wasser, Gerd

2013-06-01

Modern computer systems allow limits to be set on the periods allowed for repetitive testing. We investigated a computerised system for managing potentially overtly frequent laboratory testing, calculating the financial savings obtained. In consultation with hospital physicians, tests were selected for which 'spare periods' (periods during which tests are barred) might be set to control repetitive testing. The tests were selected and spare periods determined based on known analyte variations in health and disease, variety of tissues or cells giving rise to analytes, clinical conditions and rate of change determining analyte levels, frequency with which doctors need information about the analytes and the logistical needs of the clinic. The operation and acceptance of the system was explored with 23 analytes. Frequency filtering was subsequently introduced for 44 tests, each with their own spare periods. The proportion of tests barred was 0.56%, the most frequent of these being for total cholesterol, uric acid and HDL-cholesterol. The financial savings were 0.33% of the costs of all testing, with HbA1c, HDL-cholesterol and vitamin B12 yielding the largest savings. Following the introduction of the system the number of barred tests ultimately decreased, suggesting accommodation by the test requestors. Managing laboratory testing through computerised limits to prevent overtly frequent testing is feasible. The savings were relatively low, but sustaining the system takes little effort, giving little reason not to apply it. The findings will serve as a basis for improving the system and may guide others in introducing similar systems.

Crime Laboratory Proficiency Testing Research Program.

ERIC Educational Resources Information Center

Peterson, Joseph L.; And Others

A three-year research effort was conducted to design a crime laboratory proficiency testing program encompassing the United States. The objectives were to: (1) determine the feasibility of preparation and distribution of different classes of physical evidence; (2) assess the accuracy of criminalistics laboratories in the processing of selected…

42 CFR 493.1487 - Condition: Laboratories performing high complexity testing; testing personnel.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Condition: Laboratories performing high complexity testing; testing personnel. 493.1487 Section 493.1487 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY...

42 CFR 493.1487 - Condition: Laboratories performing high complexity testing; testing personnel.

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; testing personnel. 493.1487 Section 493.1487 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY...

Battery testing at Argonne National Laboratory

NASA Astrophysics Data System (ADS)

Deluca, W. H.; Gillie, K. R.; Kulaga, J. E.; Smaga, J. A.; Tummillo, A. F.; Webster, C. E.

Advanced battery technology evaluations are performed under simulated electric-vehicle operating conditions at the Analysis & Diagnostic Laboratory (ADL) of Argonne National Laboratory. The ADL results provide insight into those factors that limit battery performance and life. The ADL facilities include a test laboratory to conduct battery experimental evaluations under simulated application conditions and a post-test analysis laboratory to determine, in a protected atmosphere if needed, component compositional changes and failure mechanisms. This paper summarizes the performance characterizations and life evaluations conducted during FY-92 on both single cells and multi-cell modules that encompass six battery technologies (Na/S, Li/FeS, Ni/Metal-Hydride, Ni/Zn, Ni/Cd, Ni/Fe). These evaluations were performed for the Department of Energy, Office of Transportation Technologies, Electric and Hybrid Propulsion Division, and the Electric Power Research Institute. The ADL provides a common basis for battery performance characterization and life evaluations with unbiased application of tests and analyses. The results help identify the most promising R&D approaches for overcoming battery limitations, and provide battery users, developers, and program managers with a measure of the progress being made in battery R&D programs, a comparison of battery technologies, and basic data for modeling.

Total laboratory automation: Do stat tests still matter?

PubMed

Dolci, Alberto; Giavarina, Davide; Pasqualetti, Sara; Szőke, Dominika; Panteghini, Mauro

2017-07-01

During the past decades the healthcare systems have rapidly changed and today hospital care is primarily advocated for critical patients and acute treatments, for which laboratory test results are crucial and need to be always reported in predictably short turnaround time (TAT). Laboratories in the hospital setting can face this challenge by changing their organization from a compartmentalized laboratory department toward a decision making-based laboratory department. This requires the implementation of a core laboratory, that exploits total laboratory automation (TLA) using technological innovation in analytical platforms, track systems and information technology, including middleware, and a number of satellite specialized laboratory sections cooperating with care teams for specific medical conditions. In this laboratory department model, the short TAT for all first-line tests performed by TLA in the core laboratory represents the key paradigm, where no more stat testing is required because all samples are handled in real-time and (auto)validated results dispatched in a time that fulfills clinical needs. To optimally reach this goal, laboratories should be actively involved in managing all the steps covering the total examination process, speeding up also extra-laboratory phases, such sample delivery. Furthermore, to warrant effectiveness and not only efficiency, all the processes, e.g. specimen integrity check, should be managed by middleware through a predefined set of rules defined in light of the clinical governance. Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

21 CFR 640.67 - Laboratory tests.

Code of Federal Regulations, 2010 CFR

2010-04-01

... ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.67 Laboratory tests. Each unit of Source Plasma shall be tested for evidence of infection due to communicable disease agents as required...

21 CFR 640.67 - Laboratory tests.

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.67 Laboratory tests. Each unit of Source Plasma shall be tested for evidence of infection due to communicable disease agents as required...

21 CFR 640.67 - Laboratory tests.

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.67 Laboratory tests. Each unit of Source Plasma shall be tested for evidence of infection due to communicable disease agents as required...

21 CFR 640.67 - Laboratory tests.

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.67 Laboratory tests. Each unit of Source Plasma shall be tested for evidence of infection due to communicable disease agents as required...

21 CFR 640.67 - Laboratory tests.

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.67 Laboratory tests. Each unit of Source Plasma shall be tested for evidence of infection due to communicable disease agents as required...

Laboratory testing of two prototype in-vehicle breath test devices

DOT National Transportation Integrated Search

1985-08-01

This report presents the results of laboratory testing of two recently developed prototype in-vehicle breath test devices. These devices are designed to prevent persons with alcohol on their breath from driving a car. The devices tested were the SOBE...

Impact of Laboratory Test Use Strategies in a Turkish Hospital

PubMed Central

Yılmaz, Fatma Meriç; Kahveci, Rabia; Aksoy, Altan; Özer Kucuk, Emine; Akın, Tezcan; Mathew, Joseph Lazar; Meads, Catherine; Zengin, Nurullah

2016-01-01

Objectives Eliminating unnecessary laboratory tests is a good way to reduce costs while maintain patient safety. The aim of this study was to define and process strategies to rationalize laboratory use in Ankara Numune Training and Research Hospital (ANH) and calculate potential savings in costs. Methods A collaborative plan was defined by hospital managers; joint meetings with ANHTA and laboratory professors were set; the joint committee invited relevant staff for input, and a laboratory efficiency committee was created. Literature was reviewed systematically to identify strategies used to improve laboratory efficiency. Strategies that would be applicable in local settings were identified for implementation, processed, and the impact on clinical use and costs assessed for 12 months. Results Laboratory use in ANH differed enormously among clinics. Major use was identified in internal medicine. The mean number of tests per patient was 15.8. Unnecessary testing for chloride, folic acid, free prostate specific antigen, hepatitis and HIV testing were observed. Test panel use was pinpointed as the main cause of overuse of the laboratory and the Hospital Information System test ordering page was reorganized. A significant decrease (between 12.6–85.0%) was observed for the tests that were taken to an alternative page on the computer screen. The one year study saving was equivalent to 371,183 US dollars. Conclusion Hospital-based committees including laboratory professionals and clinicians can define hospital based problems and led to a standardized approach to test use that can help clinicians reduce laboratory costs through appropriate use of laboratory tests. PMID:27077653

42 CFR 493.1403 - Condition: Laboratories performing moderate complexity testing; laboratory director.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Condition: Laboratories performing moderate complexity testing; laboratory director. 493.1403 Section 493.1403 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION...

42 CFR 493.1403 - Condition: Laboratories performing moderate complexity testing; laboratory director.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Condition: Laboratories performing moderate complexity testing; laboratory director. 493.1403 Section 493.1403 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION...

Point-of-Care Test Equipment for Flexible Laboratory Automation.

PubMed

You, Won Suk; Park, Jae Jun; Jin, Sung Moon; Ryew, Sung Moo; Choi, Hyouk Ryeol

2014-08-01

Blood tests are some of the core clinical laboratory tests for diagnosing patients. In hospitals, an automated process called total laboratory automation, which relies on a set of sophisticated equipment, is normally adopted for blood tests. Noting that the total laboratory automation system typically requires a large footprint and significant amount of power, slim and easy-to-move blood test equipment is necessary for specific demands such as emergency departments or small-size local clinics. In this article, we present a point-of-care test system that can provide flexibility and portability with low cost. First, the system components, including a reagent tray, dispensing module, microfluidic disk rotor, and photometry scanner, and their functions are explained. Then, a scheduler algorithm to provide a point-of-care test platform with an efficient test schedule to reduce test time is introduced. Finally, the results of diagnostic tests are presented to evaluate the system. © 2014 Society for Laboratory Automation and Screening.

Laboratory development and testing of spacecraft diagnostics

NASA Astrophysics Data System (ADS)

Amatucci, William; Tejero, Erik; Blackwell, Dave; Walker, Dave; Gatling, George; Enloe, Lon; Gillman, Eric

2017-10-01

The Naval Research Laboratory's Space Chamber experiment is a large-scale laboratory device dedicated to the creation of large-volume plasmas with parameters scaled to realistic space plasmas. Such devices make valuable contributions to the investigation of space plasma phenomena under controlled, reproducible conditions, allowing for the validation of theoretical models being applied to space data. However, in addition to investigations such as plasma wave and instability studies, such devices can also make valuable contributions to the development and testing of space plasma diagnostics. One example is the plasma impedance probe developed at NRL. Originally developed as a laboratory diagnostic, the sensor has now been flown on a sounding rocket, is included on a CubeSat experiment, and will be included on the DoD Space Test Program's STP-H6 experiment on the International Space Station. In this talk, we will describe how the laboratory simulation of space plasmas made this development path possible. Work sponsored by the US Naval Research Laboratory Base Program.

Routine admission laboratory testing for general medical patients.

PubMed

Hubbell, F A; Frye, E B; Akin, B V; Rucker, L

1988-06-01

We evaluated the usefulness of commonly ordered routine admission laboratory tests in 301 patients admitted consecutively to the internal medicine wards of a university teaching hospital. Using a consensus analysis approach, three Department of Medicine faculty members reviewed the charts of admitted patients to determine the impact of the test results on patient care. The evaluated tests were the urinalysis, hematocrit, white blood cell count, platelet count, six-factor automated multiple analysis (serum sodium, potassium, chloride, bicarbonate, glucose, and blood urea nitrogen), prothrombin time, partial thromboplastin time, chest x-ray, and electrocardiogram. Forty-five percent of the 3,684 tests were ordered for patients without recognizable medical indications. Twelve percent of these routine tests were abnormal, 5% led to additional laboratory testing, but only 0.5% led to change in the treatment of patients. We conclude that the impact of routine admission laboratory testing on patient care is very small and that there is little justification for ordering tests solely because of hospital admission.

1. VIEW EAST, COMPONENTS TEST LABORATORY SHOWING CATCH BASINS, TURBINE ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

1. VIEW EAST, COMPONENTS TEST LABORATORY SHOWING CATCH BASINS, TURBINE TESTING AREA, AND PUMP TESTING TOWER. - Marshall Space Flight Center, East Test Area, Components Test Laboratory, Huntsville, Madison County, AL

Laboratory testing of Alcoscan saliva-alcohol test strips

DOT National Transportation Integrated Search

1986-10-01

This report describes a laboratory evaluation of Alcoscan saliva-alcohol test strips. The objectives of this work were: (1) to determine the precision and accuracy of the Alcoscan strips; and (2) to determine what effect extreme ambient temperatures ...

AAPT Lab Recommendations: Past, Present, and Future

NASA Astrophysics Data System (ADS)

Kozminski, Joseph

The ``AAPT Recommendations for the Undergraduate Physics Laboratory Curriculum'' was endorsed by the American Association of Physics Teachers Executive Board in November 2014. This set of curriculum recommendations focuses on developing skills and competencies that will prepare students for research in graduate school and for jobs in the STEM sector, education, and many other employment sectors. The recommendations can be used to guide changes in laboratory curricula, to assess department laboratory curricula during program reviews, and to educate university officials about the importance of laboratory experiences. The recommendations offer many potential opportunities for collaboration between physics education researchers and laboratory instructors in studying skill development in the lab and how various elements of the laboratory curriculum can best be assessed. There are also discussions underway to create an online resource for laboratory instructors to share implementation ideas and resources. This presentation provides an overview of these recommendations and their development, how the recommendations are currently being used, and opportunities for expanded use of the recommendations going forward.

9 CFR 147.17 - Laboratory procedure recommended for the bacteriological examination of cull chicks and poults...

Code of Federal Regulations, 2013 CFR

2013-01-01

... the bacteriological examination of cull chicks and poults for salmonella. 147.17 Section 147.17... poults for salmonella. The laboratory procedure described in this section is recommended for the bacteriological examination of cull chicks from egg-type and meat-type chicken flocks and waterfowl, exhibition...

9 CFR 147.17 - Laboratory procedure recommended for the bacteriological examination of cull chicks and poults...

Code of Federal Regulations, 2011 CFR

2011-01-01

... the bacteriological examination of cull chicks and poults for salmonella. 147.17 Section 147.17... poults for salmonella. The laboratory procedure described in this section is recommended for the bacteriological examination of cull chicks from egg-type and meat-type chicken flocks and waterfowl, exhibition...

9 CFR 147.17 - Laboratory procedure recommended for the bacteriological examination of cull chicks and poults...

Code of Federal Regulations, 2012 CFR

2012-01-01

... the bacteriological examination of cull chicks and poults for salmonella. 147.17 Section 147.17... poults for salmonella. The laboratory procedure described in this section is recommended for the bacteriological examination of cull chicks from egg-type and meat-type chicken flocks and waterfowl, exhibition...

9 CFR 147.17 - Laboratory procedure recommended for the bacteriological examination of cull chicks and poults...

Code of Federal Regulations, 2010 CFR

2010-01-01

... the bacteriological examination of cull chicks and poults for salmonella. 147.17 Section 147.17... poults for salmonella. The laboratory procedure described in this section is recommended for the bacteriological examination of cull chicks from egg-type and meat-type chicken flocks and waterfowl, exhibition...

9 CFR 147.17 - Laboratory procedure recommended for the bacteriological examination of cull chicks and poults...

Code of Federal Regulations, 2014 CFR

2014-01-01

... the bacteriological examination of cull chicks and poults for salmonella. 147.17 Section 147.17... poults for salmonella. The laboratory procedure described in this section is recommended for the bacteriological examination of cull chicks from egg-type and meat-type chicken flocks and waterfowl, exhibition...

Some Remarks on Practical Aspects of Laboratory Testing of Deep Soil Mixing Composites Achieved in Organic Soils

NASA Astrophysics Data System (ADS)

Kanty, Piotr; Rybak, Jarosław; Stefaniuk, Damian

2017-10-01

This paper presents the results of laboratory testing of organic soil-cement samples are presented in the paper. The research program continues previously reported the authors’ experiences with cement-fly ash-soil sample testing. Over 100 of compression and a dozen of tension tests have been carried out altogether. Several samples were waiting for failure test for over one year after they were formed. Several factors, like: the large amount of the tested samples, a long observation time, carrying out the tests in complex cycles of loading and the possibility of registering the loads and deformation in the axial and lateral direction - have made it possible to take into consideration numerous interdependencies, three of which have been presented in this work: the increments of compression strength, the stiffness of soil-cement in relation to strength and the tensile strength. Compressive strength, elastic modulus and tensile resistance of cubic samples were examined. Samples were mixed and stored in the laboratory conditions. Further numerical analysis in the Finite Element Method numerical code Z_Soil, were performed on the basis of laboratory test results. Computations prove that cement-based stabilization of organic soil brings serious risks (in terms of material capacity and stiffness) and Deep Soil Mixing technology should not be recommended for achieving it. The numerical analysis presented in the study below includes only one type of organic and sandy soil and several possible geometric combinations. Despite that, it clearly points to the fact that designing the DSM columns in the organic soil may be linked with a considerable risk and the settlement may reach too high values. During in situ mixing, the organic material surrounded by sand layers surely mixes with one another in certain areas. However, it has not been examined and it is difficult to assume such mixing already at the designing stage. In case of designing the DSM columns which goes through a

Laboratory and clinical evaluation of on-site urine drug testing.

PubMed

Beck, Olof; Carlsson, Sten; Tusic, Marinela; Olsson, Robert; Franzen, Lisa; Hulten, Peter

2014-11-01

Products for on-site urine drug testing offer the possibility to perform screening for drugs of abuse directly at the point-of-care. This is a well-established routine in emergency and dependency clinics but further evaluation of performance is needed due to inherent limitations with the available products. Urine drug testing by an on-site product was compared with routine laboratory methods. First, on-site testing was performed at the laboratory in addition to the routine method. Second, the on-site testing was performed at a dependency clinic and urine samples were subsequently sent to the laboratory for additional analytical investigation. The on-site testing products did not perform with assigned cut-off levels. The subjective reading between the presence of a spot (i.e. negative test result) being present or no spot (positive result) was difficult in 3.2% of the cases, and occurred for all parameters. The tests performed more accurately in drug negative samples (specificity 96%) but less accurately for detecting positives (sensitivity 79%). Of all incorrect results by the on-site test the proportion of false negatives was 42%. The overall agreement between on-site and laboratory testing was 95% in the laboratory study and 98% in the clinical study. Although a high degree of agreement was observed between on-site and routine laboratory urine drug testing, the performance of on-site testing was not acceptable due to significant number of false negative results. The limited sensitivity of on-site testing compared to laboratory testing reduces the applicability of these tests.

Hepatitis C Testing Increased Among Baby Boomers Following The 2012 Change To CDC Testing Recommendations.

PubMed

Barocas, Joshua A; Wang, Jianing; White, Laura F; Tasillo, Abriana; Salomon, Joshua A; Freedberg, Kenneth A; Linas, Benjamin P

2017-12-01

In 2012 the Centers for Disease Control and Prevention recommended routine testing for hepatitis C for people born in the period 1945-65. Until now, the recommendation's impact on hepatitis C screening rates in the United States has not been fully understood. We used an interrupted time series with comparison group design to analyze hepatitis C screening rates in the period 2010-14 among 2.8 million commercially insured adults in the MarketScan database. Hepatitis C screening rates increased yearly between 2010 and 2014, from 1.65 to 2.59 per 100 person-years. A 49 percent increase in screening rates among people born during 1945-65 followed the release of the recommendation, but no such increase was observed among adults born after 1965. The effect among the target population was sustained, and by twenty-four months after the recommendation's release, screening rates had increased 106 percent. We conclude that the hepatitis C testing policy change resulted in significantly increased testing among the target population and may have decreased the magnitude of the hepatitis C epidemic.

Laboratory Diagnosis of Zika Virus Infection.

PubMed

Landry, Marie Louise; St George, Kirsten

2017-01-01

-The rapid and accurate diagnosis of Zika virus infection is an international priority. -To review current recommendations, methods, limitations, and priorities for Zika virus testing. -Sources include published literature, public health recommendations, laboratory procedures, and testing experience. -Until recently, the laboratory diagnosis of Zika infection was confined to public health or research laboratories that prepared their own reagents, and test capacity has been limited. Furthermore, Zika cross-reacts serologically with other flaviviruses, such as dengue, West Nile, and yellow fever. Current or past infection, or even vaccination with another flavivirus, will often cause false-positive or uninterpretable Zika serology results. Detection of viral RNA during acute infection using nucleic acid amplification tests provides more specific results, and a number of commercial nucleic acid amplification tests have received emergency use authorization. In addition to serum, testing of whole blood and urine is recommended because of the higher vial loads and longer duration of shedding. However, nucleic acid amplification testing has limited utility because many patients are asymptomatic or present for testing after the brief period of Zika shedding has passed. Thus, the greatest need and most difficult challenge is development of accurate antibody tests for the diagnosis of recent Zika infection. Research is urgently needed to identify Zika virus epitopes that do not cross-react with other flavivirus antigens. New information is emerging at a rapid pace and, with ongoing public-private and international collaborations and government support, it is hoped that rapid progress will be made in developing robust and widely applicable diagnostic tools.

A system dynamics approach to analyze laboratory test errors.

PubMed

Guo, Shijing; Roudsari, Abdul; Garcez, Artur d'Avila

2015-01-01

Although many researches have been carried out to analyze laboratory test errors during the last decade, it still lacks a systemic view of study, especially to trace errors during test process and evaluate potential interventions. This study implements system dynamics modeling into laboratory errors to trace the laboratory error flows and to simulate the system behaviors while changing internal variable values. The change of the variables may reflect a change in demand or a proposed intervention. A review of literature on laboratory test errors was given and provided as the main data source for the system dynamics model. Three "what if" scenarios were selected for testing the model. System behaviors were observed and compared under different scenarios over a period of time. The results suggest system dynamics modeling has potential effectiveness of helping to understand laboratory errors, observe model behaviours, and provide a risk-free simulation experiments for possible strategies.

Variations in biochemical values for common laboratory tests: a comparison among multi-ethnic Israeli women cohort.

PubMed

Birk, Ruth; Heifetz, Eliyahu M

2018-04-28

Biochemical laboratory values are an essential tool in medical diagnosis, treatment, and follow-up; however, they are known to vary between populations. Establishment of ethnicity-adjusted reference values is recommended by health organizations. To investigate the ethnicity element in biochemical lab values studying women of different ethnic groups. Biochemical lab values (n = 27) of 503 adult Israeli women of three ethnicities (Jewish Ashkenazi, Jewish Sephardic, and Bedouin Arab) attending a single medical center were analyzed. Biochemical data were extracted from medical center records. Ethnic differences of laboratory biochemicals were studied using ANCOVA to analyze the center of the distribution as well as quartile regression analysis to analyze the upper and lower limits, both done with an adjustment for age. Significant ethnic differences were found in almost half (n = 12) of the biochemical laboratory tests. Ashkenazi Jews exhibited significantly higher mean values compared to Bedouins in most of the biochemical tests, including albumin, alkaline phosphatase, calcium, cholesterol, cholesterol LDL and HDL, cholesterol LDL calc., folic acid, globulin, and iron saturation, while the Bedouins exhibited the highest mean values in the creatinine and triglycerides. For most of these tests, Sephardic Jews exhibited biochemical mean levels in between the two other groups. Compared to Ashkenazi Jews, Sephardic Jews had a significant shift to lower values in cholesterol LDL. Ethnic subpopulations have distinct distributions in biochemical laboratory test values, which should be taken into consideration in medical practice enabling precision medicine.

Iowa Central Quality Fuel Testing Laboratory

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

Heach, Don; Bidieman, Julaine

2013-09-30

The objective of this project is to finalize the creation of an independent quality fuel testing laboratory on the campus of Iowa Central Community College in Fort Dodge, Iowa that shall provide the exploding biofuels industry a timely and cost-effective centrally located laboratory to complete all state and federal fuel and related tests that are required. The recipient shall work with various state regulatory agencies, biofuel companies and state and national industry associations to ensure that training and testing needs of their members and American consumers are met. The recipient shall work with the Iowa Department of Ag and Landmore » Stewardship on the development of an Iowa Biofuel Quality Standard along with the Development of a standard that can be used throughout industry.« less

Developing a cardiopulmonary exercise testing laboratory.

PubMed

Diamond, Edward

2007-12-01

Cardiopulmonary exercise testing is a noninvasive and cost-effective technique that adds significant value to the assessment and management of a variety of symptoms and diseases. The penetration of this testing in medical practice may be limited by perceived operational and financial barriers. This article reviews coding and supervision requirements related to both simple and complex pulmonary stress testing. A program evaluation and review technique diagram is used to describe the work flow process. Data from our laboratory are used to generate an income statement that separates fixed and variable costs and calculates the contribution margin. A cost-volume-profit (break-even) analysis is then performed. Using data from our laboratory including fixed and variable costs, payer mix, reimbursements by payer, and the assumption that the studies are divided evenly between simple and complex pulmonary stress tests, the break-even number is calculated to be 300 tests per year. A calculator with embedded formulas has been designed by the author and is available on request. Developing a cardiopulmonary exercise laboratory is challenging but achievable and potentially profitable. It should be considered by a practice that seeks to distinguish itself as a quality leader. Providing this clinically valuable service may yield indirect benefits such as increased patient volume and increased utilization of other services provided by the practice. The decision for a medical practice to commit resources to managerial accounting support requires a cost-benefit analysis, but may be a worthwhile investment in our challenging economic environment.

CTBTO Contractor Laboratory Test Sample Production Report

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

Bob Hague; Tracy Houghton; Nick Mann

2013-08-01

In October 2012 scientists from both Idaho National Laboratory (INL) and the CTBTO contact laboratory at Seibersdorf, Austria designed a system and capability test to determine if the INL could produce and deliver a short lived radio xenon standard in time for the standard to be measured at the CTBTO contact laboratory at Seibersdorf, Austria. The test included sample standard transportation duration and potential country entrance delays at customs. On October 23, 2012 scientists at the Idaho National Laboratory (INL) prepared and shipped a Seibersdorf contract laboratory supplied cylinder. The canister contained 1.0 scc of gas that consisted of 70%more » xenon and 30% nitrogen by volume. The t0 was October 24, 2012, 1200 ZULU. The xenon content was 0.70 +/ 0.01 scc at 0 degrees C. The 133mXe content was 4200 +/ 155 dpm per scc of stable xenon on t0 (1 sigma uncertainty). The 133Xe content was 19000 +/ 800 dpm per scc of stable xenon on t0 (1 sigma uncertainty).« less

Parachute Testing for Mars Science Laboratory

NASA Technical Reports Server (NTRS)

2007-01-01

The team developing the landing system for NASA's Mars Science Laboratory tested the deployment of an early parachute design in mid-October 2007 inside the world's largest wind tunnel, at NASA Ames Research Center, Moffett Field, California.

In this image, an engineer is dwarfed by the parachute, which holds more air than a 280-square-meter (3,000-square-foot) house and is designed to survive loads in excess of 36,000 kilograms (80,000 pounds).

The parachute, built by Pioneer Aerospace, South Windsor, Connecticut, has 80 suspension lines, measures more than 50 meters (165 feet) in length, and opens to a diameter of nearly 17 meters (55 feet). It is the largest disk-gap-band parachute ever built and is shown here inflated in the test section with only about 3.8 meters (12.5 feet) of clearance to both the floor and ceiling.

The wind tunnel, which is 24 meters (80 feet) tall and 37 meters (120 feet) wide and big enough to house a Boeing 737, is part of the National Full-Scale Aerodynamics Complex, operated by the U.S. Air Force, Arnold Engineering Development Center.

NASA's Jet Propulsion Laboratory, Pasadena, California, is building and testing the Mars Science Laboratory spacecraft for launch in 2009. The mission will land a roving analytical laboratory on the surface of Mars in 2010. JPL is a division of the California Institute of Technology.

Inter-laboratory Comparison of Three Earplug Fit-test Systems

PubMed Central

Byrne, David C.; Murphy, William J.; Krieg, Edward F.; Ghent, Robert M.; Michael, Kevin L.; Stefanson, Earl W.; Ahroon, William A.

2017-01-01

The National Institute for Occupational Safety and Health (NIOSH) sponsored tests of three earplug fit-test systems (NIOSH HPD Well-Fit™, Michael & Associates FitCheck, and Honeywell Safety Products VeriPRO®). Each system was compared to laboratory-based real-ear attenuation at threshold (REAT) measurements in a sound field according to ANSI/ASA S12.6-2008 at the NIOSH, Honeywell Safety Products, and Michael & Associates testing laboratories. An identical study was conducted independently at the U.S. Army Aeromedical Research Laboratory (USAARL), which provided their data for inclusion in this report. The Howard Leight Airsoft premolded earplug was tested with twenty subjects at each of the four participating laboratories. The occluded fit of the earplug was maintained during testing with a soundfield-based laboratory REAT system as well as all three headphone-based fit-test systems. The Michael & Associates lab had highest average A-weighted attenuations and smallest standard deviations. The NIOSH lab had the lowest average attenuations and the largest standard deviations. Differences in octave-band attenuations between each fit-test system and the American National Standards Institute (ANSI) sound field method were calculated (Attenfit-test - AttenANSI). A-weighted attenuations measured with FitCheck and HPD Well-Fit systems demonstrated approximately ±2 dB agreement with the ANSI sound field method, but A-weighted attenuations measured with the VeriPRO system underestimated the ANSI laboratory attenuations. For each of the fit-test systems, the average A-weighted attenuation across the four laboratories was not significantly greater than the average of the ANSI sound field method. Standard deviations for residual attenuation differences were about ±2 dB for FitCheck and HPD Well-Fit compared to ±4 dB for VeriPRO. Individual labs exhibited a range of agreement from less than a dB to as much as 9.4 dB difference with ANSI and REAT estimates. Factors such as

30 CFR 14.21 - Laboratory-scale flame test apparatus.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Laboratory-scale flame test apparatus. 14.21 Section 14.21 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING... Technical Requirements § 14.21 Laboratory-scale flame test apparatus. The principal parts of the apparatus...

30 CFR 14.21 - Laboratory-scale flame test apparatus.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Laboratory-scale flame test apparatus. 14.21 Section 14.21 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING... Technical Requirements § 14.21 Laboratory-scale flame test apparatus. The principal parts of the apparatus...

Evaluating a mobile application for improving clinical laboratory test ordering and diagnosis.

PubMed

Meyer, Ashley N D; Thompson, Pamela J; Khanna, Arushi; Desai, Samir; Mathews, Benji K; Yousef, Elham; Kusnoor, Anita V; Singh, Hardeep

2018-04-20

Mobile applications for improving diagnostic decision making often lack clinical evaluation. We evaluated if a mobile application improves generalist physicians' appropriate laboratory test ordering and diagnosis decisions and assessed if physicians perceive it as useful for learning. In an experimental, vignette study, physicians diagnosed 8 patient vignettes with normal prothrombin times (PT) and abnormal partial thromboplastin times (PTT). Physicians made test ordering and diagnosis decisions for 4 vignettes using each resource: a mobile app, PTT Advisor, developed by the Centers for Disease Control and Prevention (CDC)'s Clinical Laboratory Integration into Healthcare Collaborative (CLIHC); and usual clinical decision support. Then, physicians answered questions regarding their perceptions of the app's usefulness for diagnostic decision making and learning using a modified Kirkpatrick Training Evaluation Framework. Data from 368 vignettes solved by 46 physicians at 7 US health care institutions show advantages for using PTT Advisor over usual clinical decision support on test ordering and diagnostic decision accuracy (82.6 vs 70.2% correct; P < .001), confidence in decisions (7.5 vs 6.3 out of 10; P < .001), and vignette completion time (3:02 vs 3:53 min.; P = .06). Physicians reported positive perceptions of the app's potential for improved clinical decision making, and recommended it be used to address broader diagnostic challenges. A mobile app, PTT Advisor, may contribute to better test ordering and diagnosis, serve as a learning tool for diagnostic evaluation of certain clinical disorders, and improve patient outcomes. Similar methods could be useful for evaluating apps aimed at improving testing and diagnosis for other conditions.

Developing laboratory networks: a practical guide and application.

PubMed

Kirk, Carol J; Shult, Peter A

2010-01-01

The role of the public health laboratory (PHL) in support of public health response has expanded beyond testing to include a number of other core functions, such as emergency response, training and outreach, communications, laboratory-based surveillance, and laboratory data management. These functions can only be accomplished by a network that includes public health and other agency laboratories and clinical laboratories. It is a primary responsibility of the PHL to develop and maintain such a network. In this article, we present practical recommendations-based on 17 years of network development experience-for the development of statewide laboratory networks. These recommendations, and examples of current laboratory networks, are provided to facilitate laboratory network development in other states. The development of laboratory networks will enhance each state's public health system and is critical to the development of a robust national Laboratory Response Network.

11. Interior view of control room in Components Test Laboratory ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

11. Interior view of control room in Components Test Laboratory (T-27), looking north. Photograph shows upgraded instrumentation, piping, and technological modifications installed in 1997-99 to accommodate component testing requirements for the Atlas V missile. - Air Force Plant PJKS, Systems Integration Laboratory, Components Test Laboratory, Waterton Canyon Road & Colorado Highway 121, Lakewood, Jefferson County, CO

19 CFR 151.71 - Laboratory testing for clean yield.

Code of Federal Regulations, 2011 CFR

2011-04-01

... OF THE TREASURY (CONTINUED) EXAMINATION, SAMPLING, AND TESTING OF MERCHANDISE Wool and Hair § 151.71... director. (b) Notification to importer. Where samples of wool or hair have been tested in a Customs... laboratory test is not feasible, the wool or hair may be retested by a commercial laboratory in accordance...

19 CFR 151.71 - Laboratory testing for clean yield.

Code of Federal Regulations, 2013 CFR

2013-04-01

... OF THE TREASURY (CONTINUED) EXAMINATION, SAMPLING, AND TESTING OF MERCHANDISE Wool and Hair § 151.71... director. (b) Notification to importer. Where samples of wool or hair have been tested in a Customs... laboratory test is not feasible, the wool or hair may be retested by a commercial laboratory in accordance...

19 CFR 151.71 - Laboratory testing for clean yield.

Code of Federal Regulations, 2014 CFR

2014-04-01

... OF THE TREASURY (CONTINUED) EXAMINATION, SAMPLING, AND TESTING OF MERCHANDISE Wool and Hair § 151.71... director. (b) Notification to importer. Where samples of wool or hair have been tested in a Customs... laboratory test is not feasible, the wool or hair may be retested by a commercial laboratory in accordance...

19 CFR 151.71 - Laboratory testing for clean yield.

Code of Federal Regulations, 2010 CFR

2010-04-01

... OF THE TREASURY (CONTINUED) EXAMINATION, SAMPLING, AND TESTING OF MERCHANDISE Wool and Hair § 151.71... director. (b) Notification to importer. Where samples of wool or hair have been tested in a Customs... laboratory test is not feasible, the wool or hair may be retested by a commercial laboratory in accordance...

19 CFR 151.71 - Laboratory testing for clean yield.

Code of Federal Regulations, 2012 CFR

2012-04-01

... OF THE TREASURY (CONTINUED) EXAMINATION, SAMPLING, AND TESTING OF MERCHANDISE Wool and Hair § 151.71... director. (b) Notification to importer. Where samples of wool or hair have been tested in a Customs... laboratory test is not feasible, the wool or hair may be retested by a commercial laboratory in accordance...

Survey of the Diagnostic Retooling Process in National TB Reference Laboratories, with Special Focus on Rapid Speciation Tests Endorsed by WHO in 2007

PubMed Central

van Kampen, Sanne C.; Oskam, Linda; Tuijn, Coosje J.; Klatser, Paul R.

2012-01-01

Background Successful integration of new diagnostics in national tuberculosis (TB) control programs, also called ‘retooling’, is highly dependent on operational aspects related to test availability, accessibility and affordability. This survey aimed to find out whether recommendations to use new diagnostics lead to successful retooling in high TB endemic countries, using immunochromatographic tests (ICTs) for TB culture speciation as a case study. ICTs are recommended to accurately confirm the presence of bacteria of the Mycobacterium tuberculosis complex in liquid culture isolates. Methods and Findings Questionnaires were sent to national TB reference laboratories (NRLs) in 42 high TB endemic countries to address their access to information on ICT implementation, logistics related to availability, accessibility and affordability of ICTs, and testing algorithms. Results from 16 responding countries indicated that half of the NRLs were aware of the contents of WHO guidance documents on liquid culture and ICT implementation, as well as their eligibility for a negotiated pricing agreement for ICT procurement. No major issues with availability and accessibility of ICTs were raised. When asked about testing algorithms, ICTs were not used as stand-alone or first test for TB culture identification as recommended by WHO. Conclusions The low response rate was a limitation of this survey and together with NRLs managers' unawareness of global guidance, suggests a lack of effective communication between partners of the global laboratory network and NRLs. TB tests could become more affordable to high TB endemic countries, if the possibility to negotiate lower prices for commercial products is communicated to them more successfully. NRLs need additional guidance to identify where available technologies can be most usefully implemented and in what order, taking into account long-term laboratory strategies. PMID:22937050

[Statistical approach to evaluate the occurrence of out-of acceptable ranges and accuracy for antimicrobial susceptibility tests in inter-laboratory quality control program].

PubMed

Ueno, Tamio; Matuda, Junichi; Yamane, Nobuhisa

2013-03-01

To evaluate the occurrence of out-of acceptable ranges and accuracy of antimicrobial susceptibility tests, we applied a new statistical tool to the Inter-Laboratory Quality Control Program established by the Kyushu Quality Control Research Group. First, we defined acceptable ranges of minimum inhibitory concentration (MIC) for broth microdilution tests and inhibitory zone diameter for disk diffusion tests on the basis of Clinical and Laboratory Standards Institute (CLSI) M100-S21. In the analysis, more than two out-of acceptable range results in the 20 tests were considered as not allowable according to the CLSI document. Of the 90 participating laboratories, 46 (51%) experienced one or more occurrences of out-of acceptable range results. Then, a binomial test was applied to each participating laboratory. The results indicated that the occurrences of out-of acceptable range results in the 11 laboratories were significantly higher when compared to the CLSI recommendation (allowable rate < or = 0.05). The standard deviation indices(SDI) were calculated by using reported results, mean and standard deviation values for the respective antimicrobial agents tested. In the evaluation of accuracy, mean value from each laboratory was statistically compared with zero using a Student's t-test. The results revealed that 5 of the 11 above laboratories reported erroneous test results that systematically drifted to the side of resistance. In conclusion, our statistical approach has enabled us to detect significantly higher occurrences and source of interpretive errors in antimicrobial susceptibility tests; therefore, this approach can provide us with additional information that can improve the accuracy of the test results in clinical microbiology laboratories.

7 CFR 58.523 - Laboratory and quality control tests.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 3 2014-01-01 2014-01-01 false Laboratory and quality control tests. 58.523 Section... Service 1 Operations and Operating Procedures § 58.523 Laboratory and quality control tests. (a) Quality control tests shall be made on samples as often as necessary to determine the shelf-life and stability of...

7 CFR 58.523 - Laboratory and quality control tests.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 3 2010-01-01 2010-01-01 false Laboratory and quality control tests. 58.523 Section... Service 1 Operations and Operating Procedures § 58.523 Laboratory and quality control tests. (a) Quality control tests shall be made on samples as often as necessary to determine the shelf-life and stability of...

7 CFR 58.523 - Laboratory and quality control tests.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 3 2013-01-01 2013-01-01 false Laboratory and quality control tests. 58.523 Section... Service 1 Operations and Operating Procedures § 58.523 Laboratory and quality control tests. (a) Quality control tests shall be made on samples as often as necessary to determine the shelf-life and stability of...

7 CFR 58.523 - Laboratory and quality control tests.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 3 2011-01-01 2011-01-01 false Laboratory and quality control tests. 58.523 Section... Service 1 Operations and Operating Procedures § 58.523 Laboratory and quality control tests. (a) Quality control tests shall be made on samples as often as necessary to determine the shelf-life and stability of...

7 CFR 58.523 - Laboratory and quality control tests.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 3 2012-01-01 2012-01-01 false Laboratory and quality control tests. 58.523 Section... Service 1 Operations and Operating Procedures § 58.523 Laboratory and quality control tests. (a) Quality control tests shall be made on samples as often as necessary to determine the shelf-life and stability of...

Audit of Helicobacter pylori Testing in Microbiology Laboratories in England: To Inform Compliance with NICE Guidance and the Feasibility of Routine Antimicrobial Resistance Surveillance

PubMed Central

Allison, Rosalie; Lecky, Donna M.; Bull, Megan; Turner, Kim; Godbole, Gauri

2016-01-01

Introduction. The National Institute for Health and Clinical Excellence (NICE) guidance recommends that dyspeptic patients are tested for Helicobacter pylori using a urea breath test, stool antigen test, or serology. Antibiotic resistance in H. pylori is globally increasing, but treatment in England is rarely guided by susceptibility testing or surveillance. Aims. To determine compliance of microbiology laboratories in England with NICE guidance and whether laboratories perform culture and antibiotic susceptibility testing (AST). Methods. In 2015, 170 accredited English microbiology laboratories were surveyed, by email. Results. 121/170 (71%) laboratories responded; 96% provided H. pylori testing (78% on site). 94% provided H. pylori diagnosis using stool antigen; only four provided serology as their noninvasive test; 3/4 of these encouraged urea breath tests in their acute trusts. Only 22/94 (23%) of the laboratories performed H. pylori cultures from gastric biopsies on site; 9/22 performed AST, but the vast majority processed less than one specimen/week. Conclusions. Only five laboratories in England do not comply with NICE guidance; these will need the guidance reinforced. National surveillance needs to be implemented; culture-based AST would need to be centralised. Moving forward, detection of resistance in H. pylori from stool specimens using molecular methods (PCR) needs to be explored. PMID:27829836

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

18. Interior view of HVAC room in Components Test Laboratory ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

18. Interior view of HVAC room in Components Test Laboratory (T-27), showing northwest corner. Photograph shows upgraded instrumentation, piping, and technological modifications for HVAC system installed in 1997-99 to accommodate component testing requirements for the Atlas V missile. - Air Force Plant PJKS, Systems Integration Laboratory, Components Test Laboratory, Waterton Canyon Road & Colorado Highway 121, Lakewood, Jefferson County, CO

19. Interior view of HVAC room in Components Test Laboratory ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

19. Interior view of HVAC room in Components Test Laboratory (T-27), looking toward east wall. Photograph shows upgraded instrumentation, machinery, and technological modifications for HVAC system installed in 1997-99 to accommodate component testing requirements for the Atlas V missile. - Air Force Plant PJKS, Systems Integration Laboratory, Components Test Laboratory, Waterton Canyon Road & Colorado Highway 121, Lakewood, Jefferson County, CO

Closing the brain-to-brain loop in laboratory testing.

PubMed

Plebani, Mario; Lippi, Giuseppe

2011-07-01

Abstract The delivery of laboratory services has been described 40 years ago and defined with the foremost concept of "brain-to-brain turnaround time loop". This concept consists of several processes, including the final step which is the action undertaken on the patient based on laboratory information. Unfortunately, the need for systematic feedback to improve the value of laboratory services has been poorly understood and, even more risky, poorly applied in daily laboratory practice. Currently, major problems arise from the unavailability of consensually accepted quality specifications for the extra-analytical phase of laboratory testing. This, in turn, does not allow clinical laboratories to calculate a budget for the "patient-related total error". The definition and use of the term "total error" refers only to the analytical phase, and should be better defined as "total analytical error" to avoid any confusion and misinterpretation. According to the hierarchical approach to classify strategies to set analytical quality specifications, the "assessment of the effect of analytical performance on specific clinical decision-making" is comprehensively at the top and therefore should be applied as much as possible to address analytical efforts towards effective goals. In addition, an increasing number of laboratories worldwide are adopting risk management strategies such as FMEA, FRACAS, LEAN and Six Sigma since these techniques allow the identification of the most critical steps in the total testing process, and to reduce the patient-related risk of error. As a matter of fact, an increasing number of laboratory professionals recognize the importance of understanding and monitoring any step in the total testing process, including the appropriateness of the test request as well as the appropriate interpretation and utilization of test results.

Recommendations regarding the genetic and immunological study of reproductive dysfunction.

PubMed

Alonso-Cerezo, María Concepción; Calero Ruiz, Mercedes; Chantada-Abal, Venancio; de la Fuente-Hernández, Luis Alfonso; García-Cobaleda, Inmaculada; García-Ochoa, Carlos; García-Sagredo, José Miguel; Nuñez, Rocío; Oliva, Rafael; Orera-Clemente, María; Pintado-Vera, David; Sanchez-Ramon, Silvia

2018-04-19

In this article several members of diverse scientific associations and reproduction experts from Spain have updated different genetic and immunological procedure recommendations in couples affected by reproductive dysfunction with the goal of providing a set of useful guidelines for the clinic. The laboratory test has been considered as highly recommendable for making clinical decisions when the result of the diagnostic test is relevant, moderately recommendable when the results are of limited evidence because they are inconsistent, and low when the benefit of the test is uncertain. It is expected that these recommendations will provide some useful guidelines for the diagnosis, prognosis and treatment of couples presenting reproductive dysfunction. Copyright © 2018 Elsevier España, S.L.U. All rights reserved.

Errors in clinical laboratories or errors in laboratory medicine?

PubMed

Plebani, Mario

2006-01-01

Laboratory testing is a highly complex process and, although laboratory services are relatively safe, they are not as safe as they could or should be. Clinical laboratories have long focused their attention on quality control methods and quality assessment programs dealing with analytical aspects of testing. However, a growing body of evidence accumulated in recent decades demonstrates that quality in clinical laboratories cannot be assured by merely focusing on purely analytical aspects. The more recent surveys on errors in laboratory medicine conclude that in the delivery of laboratory testing, mistakes occur more frequently before (pre-analytical) and after (post-analytical) the test has been performed. Most errors are due to pre-analytical factors (46-68.2% of total errors), while a high error rate (18.5-47% of total errors) has also been found in the post-analytical phase. Errors due to analytical problems have been significantly reduced over time, but there is evidence that, particularly for immunoassays, interference may have a serious impact on patients. A description of the most frequent and risky pre-, intra- and post-analytical errors and advice on practical steps for measuring and reducing the risk of errors is therefore given in the present paper. Many mistakes in the Total Testing Process are called "laboratory errors", although these may be due to poor communication, action taken by others involved in the testing process (e.g., physicians, nurses and phlebotomists), or poorly designed processes, all of which are beyond the laboratory's control. Likewise, there is evidence that laboratory information is only partially utilized. A recent document from the International Organization for Standardization (ISO) recommends a new, broader definition of the term "laboratory error" and a classification of errors according to different criteria. In a modern approach to total quality, centered on patients' needs and satisfaction, the risk of errors and mistakes

5. AERIAL PHOTO OF THE COMPONENTS TEST LABORATORY DURING THE ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

5. AERIAL PHOTO OF THE COMPONENTS TEST LABORATORY DURING THE CONSTRUCTION OF THE EAST TEST AREA. 1955, FRED ORDWAY COLLECTION, U.S. SPACE AND ROCKET CENTER, HUNTSVILLE, AL. - Marshall Space Flight Center, East Test Area, Components Test Laboratory, Huntsville, Madison County, AL

Extracting laboratory test information from biomedical text

PubMed Central

Kang, Yanna Shen; Kayaalp, Mehmet

2013-01-01

Background: No previous study reported the efficacy of current natural language processing (NLP) methods for extracting laboratory test information from narrative documents. This study investigates the pathology informatics question of how accurately such information can be extracted from text with the current tools and techniques, especially machine learning and symbolic NLP methods. The study data came from a text corpus maintained by the U.S. Food and Drug Administration, containing a rich set of information on laboratory tests and test devices. Methods: The authors developed a symbolic information extraction (SIE) system to extract device and test specific information about four types of laboratory test entities: Specimens, analytes, units of measures and detection limits. They compared the performance of SIE and three prominent machine learning based NLP systems, LingPipe, GATE and BANNER, each implementing a distinct supervised machine learning method, hidden Markov models, support vector machines and conditional random fields, respectively. Results: Machine learning systems recognized laboratory test entities with moderately high recall, but low precision rates. Their recall rates were relatively higher when the number of distinct entity values (e.g., the spectrum of specimens) was very limited or when lexical morphology of the entity was distinctive (as in units of measures), yet SIE outperformed them with statistically significant margins on extracting specimen, analyte and detection limit information in both precision and F-measure. Its high recall performance was statistically significant on analyte information extraction. Conclusions: Despite its shortcomings against machine learning methods, a well-tailored symbolic system may better discern relevancy among a pile of information of the same type and may outperform a machine learning system by tapping into lexically non-local contextual information such as the document structure. PMID:24083058

Laboratory performance of sweat conductivity for the screening of cystic fibrosis.

PubMed

Greaves, Ronda F; Jolly, Lisa; Massie, John; Scott, Sue; Wiley, Veronica C; Metz, Michael P; Mackay, Richard J

2018-03-28

There are several complementary English-language guidelines for the performance of the sweat chloride test. These guidelines also incorporate information for the collection of conductivity samples. However, recommendations for the measurement and reporting of sweat conductivity are less clear than for sweat chloride. The aim of the study was to develop an understanding of the testing and reporting practices of sweat conductivity in Australasian laboratories. A survey specifically directed at conductivity testing was sent to the 12 laboratories registered with the Royal College of Pathologists of Australasia Quality Assurance Programs. Nine (75%) laboratories participated in the survey, seven of whom used Wescor Macroduct® for collecting sweat and the Wescor SWEAT·CHEK™ for conductivity testing, and the remaining two used the Wescor Nanoduct®. There was considerable variation in frequency and staffing for this test. Likewise, criteria about which patients it was inappropriate to test, definitions of adequate collection sweat rate, cutoffs and actions recommended on the basis of the result showed variations between laboratories. Variations in sweat conductivity testing and reporting reflect many of the same issues that were revealed in sweat chloride test audits and have the potential to lead to uncertainty about the result and the proper action in response to the result. We recommend that sweat testing guidelines should include clearer statements about the use of sweat conductivity.

10. Interior view of control room in Components Test Laboratory ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

10. Interior view of control room in Components Test Laboratory (T-27), looking east. The control room is located in the center of the building and abuts the Test Cell 8, 9, and 10 and equipment room wings. Photograph shows upgraded instrumentation, piping, and technological modifications installed in 1997-99 to accommodate component testing requirements for the Atlas V missile. - Air Force Plant PJKS, Systems Integration Laboratory, Components Test Laboratory, Waterton Canyon Road & Colorado Highway 121, Lakewood, Jefferson County, CO

[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.

Inter-laboratory validation of bioaccessibility testing for metals.

PubMed

Henderson, Rayetta G; Verougstraete, Violaine; Anderson, Kim; Arbildua, José J; Brock, Thomas O; Brouwers, Tony; Cappellini, Danielle; Delbeke, Katrien; Herting, Gunilla; Hixon, Greg; Odnevall Wallinder, Inger; Rodriguez, Patricio H; Van Assche, Frank; Wilrich, Peter; Oller, Adriana R

2014-10-01

Bioelution assays are fast, simple alternatives to in vivo testing. In this study, the intra- and inter-laboratory variability in bioaccessibility data generated by bioelution tests were evaluated in synthetic fluids relevant to oral, inhalation, and dermal exposure. Using one defined protocol, five laboratories measured metal release from cobalt oxide, cobalt powder, copper concentrate, Inconel alloy, leaded brass alloy, and nickel sulfate hexahydrate. Standard deviations of repeatability (sr) and reproducibility (sR) were used to evaluate the intra- and inter-laboratory variability, respectively. Examination of the sR:sr ratios demonstrated that, while gastric and lysosomal fluids had reasonably good reproducibility, other fluids did not show as good concordance between laboratories. Relative standard deviation (RSD) analysis showed more favorable reproducibility outcomes for some data sets; overall results varied more between- than within-laboratories. RSD analysis of sr showed good within-laboratory variability for all conditions except some metals in interstitial fluid. In general, these findings indicate that absolute bioaccessibility results in some biological fluids may vary between different laboratories. However, for most applications, measures of relative bioaccessibility are needed, diminishing the requirement for high inter-laboratory reproducibility in absolute metal releases. The inter-laboratory exercise suggests that the degrees of freedom within the protocol need to be addressed. Copyright © 2014 Elsevier Inc. All rights reserved.

Building a Robust 21st Century Chemical Testing Program at the U.S. Environmental Protection Agency: Recommendations for Strengthening Scientific Engagement

PubMed Central

Dantzker, Heather C.; Portier, Christopher J.

2014-01-01

Background: Biological pathway-based chemical testing approaches are central to the National Research Council’s vision for 21st century toxicity testing. Approaches such as high-throughput in vitro screening offer the potential to evaluate thousands of chemicals faster and cheaper than ever before and to reduce testing on laboratory animals. Collaborative scientific engagement is important in addressing scientific issues arising in new federal chemical testing programs and for achieving stakeholder support of their use. Objectives: We present two recommendations specifically focused on increasing scientific engagement in the U.S. Environmental Protection Agency (EPA) ToxCast™ initiative. Through these recommendations we seek to bolster the scientific foundation of federal chemical testing efforts such as ToxCast™ and the public health decisions that rely upon them. Discussion: Environmental Defense Fund works across disciplines and with diverse groups to improve the science underlying environmental health decisions. We propose that the U.S. EPA can strengthen the scientific foundation of its new chemical testing efforts and increase support for them in the scientific research community by a) expanding and diversifying scientific input into the development and application of new chemical testing methods through collaborative workshops, and b) seeking out mutually beneficial research partnerships. Conclusions: Our recommendations provide concrete actions for the U.S. EPA to increase and diversify engagement with the scientific research community in its ToxCast™ initiative. We believe that such engagement will help ensure that new chemical testing data are scientifically robust and that the U.S. EPA gains the support and acceptance needed to sustain new testing efforts to protect public health. Citation: McPartland J, Dantzker HC, Portier CJ. 2015. Building a robust 21st century chemical testing program at the U.S. Environmental Protection Agency

42 CFR 493.25 - Laboratories performing tests of high complexity.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Laboratories performing tests of high complexity. 493.25 Section 493.25 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND....25 Laboratories performing tests of high complexity. (a) A laboratory must obtain a certificate for...

42 CFR 493.25 - Laboratories performing tests of high complexity.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Laboratories performing tests of high complexity. 493.25 Section 493.25 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND....25 Laboratories performing tests of high complexity. (a) A laboratory must obtain a certificate for...

Cruise Stage Testing for Mars Science Laboratory

NASA Image and Video Library

2010-09-02

Testing of the cruise stage for NASA Mars Science Laboratory in August 2010 included a session in a facility that simulates the environment found in interplanetary space. Spacecraft technicians at JPL prepare a space-simulation test.

4. Exterior view of Components Test Laboratory (T27), looking northeast. ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

4. Exterior view of Components Test Laboratory (T-27), looking northeast. The building wing on the left houses Test Cell 8 (oxidizer) and the oxidizer storage pit or vault, and that on the right houses Test Cell 10 (environmental). - Air Force Plant PJKS, Systems Integration Laboratory, Components Test Laboratory, Waterton Canyon Road & Colorado Highway 121, Lakewood, Jefferson County, CO

5. Exterior view of Components Test Laboratory (T27), looking northwest. ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

5. Exterior view of Components Test Laboratory (T-27), looking northwest. The building wing on the left houses Test Cell 10 (environmental), and that on the right houses Test Cell 9 (fuel) and the fuel storage pit or vault. - Air Force Plant PJKS, Systems Integration Laboratory, Components Test Laboratory, Waterton Canyon Road & Colorado Highway 121, Lakewood, Jefferson County, CO

42 CFR 493.25 - Laboratories performing tests of high complexity.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 5 2014-10-01 2014-10-01 false Laboratories performing tests of high complexity. 493.25 Section 493.25 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS General Provisions § 493.25 Laboratories performing tests of high...

42 CFR 493.20 - Laboratories performing tests of moderate complexity.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 5 2014-10-01 2014-10-01 false Laboratories performing tests of moderate complexity. 493.20 Section 493.20 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS General Provisions § 493.20 Laboratories performing tests of...

Use of proficiency test performance to determine clinical laboratory director qualifications.

PubMed

Howanitz, P J

1988-04-01

Many activities and policies influence laboratory test quality. Proficiency test results are one measure of laboratory quality, and during the past 25 years, five studies have examined the relationship of laboratory director educational requirements to proficiency test results. Data from three studies support the association between director qualifications and quality as measured by proficiency test performance, whereas no relationship was found in the other two studies. Possible reasons for conflicting results include differences in database size and demographics; in addition, proficiency test results may be inappropriate, although widely used, as the sole measure of laboratory director performance.

Shield evaluation and performance testing at the USMB`s Strategic Structures Testing Laboratory

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

Barczak, T.M.; Gearhart, D.F.

1996-12-31

Historically, shield performance testing is conducted by the support manufacturers at European facilities. The U.S. Bureau of Mines (USBM) has conducted extensive research in shield Mechanics and is now opening its Strategic Structures Testing (SST) Laboratory to the mining industry for shield performance testing. The SST Laboratory provides unique shield testing capabilities using the Mine Roof Simulator (MRS) load frame. The MRS provides realistic and cost-effective shield evaluation by combining both vertical and horizontal loading into a single load cycle; whereas, several load cycles would be required to obtain this loading in a static frame. In addition to these advantages,more » the USBM acts as an independent research organization to provide an unbiased assessment of shield performance. This paper describes the USBM`s shield testing program that is designed specifically to simulate in-service mining conditions using the unique the capabilities of the SST Laboratory.« less

7 CFR 58.442 - Laboratory and quality control tests.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 3 2010-01-01 2010-01-01 false Laboratory and quality control tests. 58.442 Section... Service 1 Operations and Operating Procedures § 58.442 Laboratory and quality control tests. (a) Chemical... Methods or by other methods giving equivalent results. (b) Weight or volume control. Representative...

7 CFR 58.442 - Laboratory and quality control tests.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 3 2011-01-01 2011-01-01 false Laboratory and quality control tests. 58.442 Section... Service 1 Operations and Operating Procedures § 58.442 Laboratory and quality control tests. (a) Chemical... Methods or by other methods giving equivalent results. (b) Weight or volume control. Representative...

Effect of Accreditation on Accuracy of Diagnostic Tests in Medical Laboratories

PubMed Central

Jang, Mi-Ae; Yoon, Young Ahn; Song, Junghan; Kim, Jeong-Ho; Min, Won-Ki; Lee, Ji Sung

2017-01-01

Background Medical laboratories play a central role in health care. Many laboratories are taking a more focused and stringent approach to quality system management. In Korea, laboratory standardization efforts undertaken by the Korean Laboratory Accreditation Program (KLAP) and the Korean External Quality Assessment Scheme (KEQAS) may have facilitated an improvement in laboratory performance, but there are no fundamental studies demonstrating that laboratory standardization is effective. We analyzed the results of the KEQAS to identify significant differences between laboratories with or without KLAP and to determine the impact of laboratory standardization on the accuracy of diagnostic tests. Methods We analyzed KEQAS participant data on clinical chemistry tests such as albumin, ALT, AST, and glucose from 2010 to 2013. As a statistical parameter to assess performance bias between laboratories, we compared 4-yr variance index score (VIS) between the two groups with or without KLAP. Results Compared with the group without KLAP, the group with KLAP exhibited significantly lower geometric means of 4-yr VIS for all clinical chemistry tests (P<0.0001); this difference justified a high level of confidence in standardized services provided by accredited laboratories. Confidence intervals for the mean of each test in the two groups (accredited and non-accredited) did not overlap, suggesting that the means of the groups are significantly different. Conclusions These results confirmed that practice standardization is strongly associated with the accuracy of test results. Our study emphasizes the necessity of establishing a system for standardization of diagnostic testing. PMID:28224767

Effect of Accreditation on Accuracy of Diagnostic Tests in Medical Laboratories.

PubMed

Jang, Mi Ae; Yoon, Young Ahn; Song, Junghan; Kim, Jeong Ho; Min, Won Ki; Lee, Ji Sung; Lee, Yong Wha; Lee, You Kyoung

2017-05-01

Medical laboratories play a central role in health care. Many laboratories are taking a more focused and stringent approach to quality system management. In Korea, laboratory standardization efforts undertaken by the Korean Laboratory Accreditation Program (KLAP) and the Korean External Quality Assessment Scheme (KEQAS) may have facilitated an improvement in laboratory performance, but there are no fundamental studies demonstrating that laboratory standardization is effective. We analyzed the results of the KEQAS to identify significant differences between laboratories with or without KLAP and to determine the impact of laboratory standardization on the accuracy of diagnostic tests. We analyzed KEQAS participant data on clinical chemistry tests such as albumin, ALT, AST, and glucose from 2010 to 2013. As a statistical parameter to assess performance bias between laboratories, we compared 4-yr variance index score (VIS) between the two groups with or without KLAP. Compared with the group without KLAP, the group with KLAP exhibited significantly lower geometric means of 4-yr VIS for all clinical chemistry tests (P<0.0001); this difference justified a high level of confidence in standardized services provided by accredited laboratories. Confidence intervals for the mean of each test in the two groups (accredited and non-accredited) did not overlap, suggesting that the means of the groups are significantly different. These results confirmed that practice standardization is strongly associated with the accuracy of test results. Our study emphasizes the necessity of establishing a system for standardization of diagnostic testing. © The Korean Society for Laboratory Medicine

Identifying causes of laboratory turnaround time delay in the emergency department.

PubMed

Jalili, Mohammad; Shalileh, Keivan; Mojtahed, Ali; Mojtahed, Mohammad; Moradi-Lakeh, Maziar

2012-12-01

Laboratory turnaround time (TAT) is an important determinant of patient stay and quality of care. Our objective is to evaluate laboratory TAT in our emergency department (ED) and to generate a simple model for identifying the primary causes for delay. We measured TATs of hemoglobin, potassium, and prothrombin time tests requested in the ED of a tertiary-care, metropolitan hospital during a consecutive one-week period. The time of different steps (physician order, nurse registration, blood-draw, specimen dispatch from the ED, specimen arrival at the laboratory, and result availability) in the test turnaround process were recorded and the intervals between these steps (order processing, specimen collection, ED waiting, transit, and within-laboratory time) and total TAT were calculated. Median TATs for hemoglobin and potassium were compared with those of the 1990 Q-Probes Study (25 min for hemoglobin and 36 min for potassium) and its recommended goals (45 min for 90% of tests). Intervals were compared according to the proportion of TAT they comprised. Median TATs (170 min for 132 hemoglobin tests, 225 min for 172 potassium tests, and 195.5 min for 128 prothrombin tests) were drastically longer than Q-Probes reported and recommended TATs. The longest intervals were ED waiting time and order processing.  Laboratory TAT varies among institutions, and data are sparse in developing countries. In our ED, actions to reduce ED waiting time and order processing are top priorities. We recommend utilization of this model by other institutions in settings with limited resources to identify their own priorities for reducing laboratory TAT.

Could light meal jeopardize laboratory coagulation tests?

PubMed

Lima-Oliveira, Gabriel; Salvagno, Gian Luca; Lippi, Giuseppe; Danese, Elisa; Gelati, Matteo; Montagnana, Martina; Picheth, Geraldo; Guidi, Gian Cesare

2014-01-01

Presently the necessity of fasting time for coagulation tests is not standardized. Our hypothesis is that this can harm patient safety. This study is aimed at evaluating whether a light meal (i.e. breakfast) can jeopardize laboratory coagulation tests. A blood sample was firstly collected from 17 fasting volunteers (12 h). Immediately after blood collection, the volunteers consumed a light meal. Then samples were collected at 1, 2 and 4 h after the meal. Coagulation tests included: activated partial thromboplastin time (APTT), prothrombin time (PT), fibrinogen (Fbg), antithrombin III (AT), protein C (PC) and protein S (PS). Differences between samples were assessed by Wilcoxon ranked-pairs test. The level of statistical significance was set at P < 0.05. Mean % differences were determined and differences between and baseline and 1, 2 and 4h samples were compared with reference change value (RCV). A significantly higher % activity of AT was observed at 1 h and 4 h after meal vs. baseline specimen [113 (104-117) and 111 (107-120) vs. 109 (102-118), respectively; P = 0.029 and P = 0.016]. APTT at 2 h was found significantly lower than baseline samples [32.0 (29.9-34.8) vs. 34.1 (32.2-35.2), respectively; P = 0.041]. The results of both Fbg and PS tests were not influenced by a light meal. Furthermore, no coagulation tests had significant variation after comparison with RCV. A light meal does not influence the laboratory coagulation tests we assessed, but we suggest that the laboratory quality managers standardize the fasting time for all blood tests at 12 hours, to completely metabolize the lipids intake.

Public health consequences of a false-positive laboratory test result for Brucella--Florida, Georgia, and Michigan, 2005.

PubMed

2008-06-06

Human brucellosis, a nationally notifiable disease, is uncommon in the United States. Most human cases have occurred in returned travelers or immigrants from regions where brucellosis is endemic, or were acquired domestically from eating illegally imported, unpasteurized fresh cheeses. In January 2005, a woman aged 35 years who lived in Nassau County, Florida, received a diagnosis of brucellosis, based on results of a Brucella immunoglobulin M (IgM) enzyme immunoassay (EIA) performed in a commercial laboratory using analyte specific reagents (ASRs); this diagnosis prompted an investigation of dairy products in two other states. Subsequent confirmatory antibody testing by Brucella microagglutination test (BMAT) performed at CDC on the patient's serum was negative. The case did not meet the CDC/Council of State and Territorial Epidemiologists' (CSTE) definition for a probable or confirmed brucellosis case, and the initial EIA result was determined to be a false positive. This report summarizes the case history, laboratory findings, and public health investigations. CDC recommends that Brucella serology testing only be performed using tests cleared or approved by the Food and Drug Administration (FDA) or validated under the Clinical Laboratory Improvement Amendments (CLIA) and shown to reliably detect the presence of Brucella infection. Results from these tests should be considered supportive evidence for recent infection only and interpreted in the context of a clinically compatible illness and exposure history. EIA is not considered a confirmatory Brucella antibody test; positive screening test results should be confirmed by Brucella-specific agglutination (i.e., BMAT or standard tube agglutination test) methods.

Use and Yield of Baseline Imaging and Laboratory Testing in Stage II Breast Cancer

PubMed Central

Guo, Hao; Sutton, Jazmine; Spring, Laura; Faig, Jennifer; Dagogo-Jack, Ibiayi; Battelli, Chiara; Houlihan, Mary Jane; Yeh, Tsai-Chu; Come, Steven E.; Lin, Nancy U.

2016-01-01

Background. Despite guideline recommendations, baseline laboratory testing and advanced imaging are widely ordered in clinical practice to stage asymptomatic patients with clinical stage II breast cancer (BC). Materials and Methods. A retrospective study at two academic centers in Boston, Massachusetts, between 2006 and 2007 explored the use, results, and implications of laboratory tests, tumor markers, and imaging in patients with clinical stage II BC. Results. Among 411 patients, 233 (57%) had liver function testing, 134 (33%) had tumor marker tests, and 237 (58%) had computed tomography (CT) as part of their initial diagnostic workup. Median age was 52 (range, 23–90 years). On multivariable analysis, young age, more advanced stage, and tumor subtype (human epidermal growth receptor-positive [HER2+] and triple-negative breast cancer [TNBC]) were significantly associated with baseline CT. The rate of detection of true metastatic disease with use of baseline staging imaging was 2.1% (95% confidence interval, 0.7%–5%). It was 2.2% (3 of 135) for estrogen receptor/progesterone receptor-positive disease, 1.9% (1 of 54) for HER2+ disease, and 2.1% (1 of 48) for TNBC. At 5 years of follow-up, 46 of 406 patients were diagnosed with metastatic breast cancer. Thirty-four of 46 (73.9%) who developed recurrent disease had imaging at their initial diagnosis, and of these, five had abnormalities on their initial imaging that was correlated with where they developed metastatic disease. Conclusion. In this cohort of women with stage II BC, staging imaging at diagnosis had a low yield in detecting distant metastases (2.1%). The detection rate was not higher with HER2+ disease or TNBC, despite the trend that patients with these subtypes were more likely to undergo imaging. Implications for Practice: Despite guideline recommendations, asymptomatic patients with stage II breast cancer (BC) often undergo staging imaging with computed tomography, bone scanning, or positron

High-Value, Cost-Conscious Care: Iterative Systems-Based Interventions to Reduce Unnecessary Laboratory Testing.

PubMed

Sadowski, Brett W; Lane, Alison B; Wood, Shannon M; Robinson, Sara L; Kim, Chin Hee

2017-09-01

Inappropriate testing contributes to soaring healthcare costs within the United States, and teaching hospitals are vulnerable to providing care largely for academic development. Via its "Choosing Wisely" campaign, the American Board of Internal Medicine recommends avoiding repetitive testing for stable inpatients. We designed systems-based interventions to reduce laboratory orders for patients admitted to the wards at an academic facility. We identified the computer-based order entry system as an appropriate target for sustainable intervention. The admission order set had allowed multiple routine tests to be ordered repetitively each day. Our iterative study included interventions on the automated order set and cost displays at order entry. The primary outcome was number of routine tests controlled for inpatient days compared with the preceding year. Secondary outcomes included cost savings, delays in care, and adverse events. Data were collected over a 2-month period following interventions in sequential years and compared with the year prior. The first intervention led to 0.97 fewer laboratory tests per inpatient day (19.4%). The second intervention led to sustained reduction, although by less of a margin than order set modifications alone (15.3%). When extrapolating the results utilizing fees from the Centers for Medicare and Medicaid Services, there was a cost savings of $290,000 over 2 years. Qualitative survey data did not suggest an increase in care delays or near-miss events. This series of interventions targeting unnecessary testing demonstrated a sustained reduction in the number of routine tests ordered, without adverse effects on clinical care. Published by Elsevier Inc.

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...

2. Exterior view of Components Test Laboratory (T27), looking southeast. ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

2. Exterior view of Components Test Laboratory (T-27), looking southeast. The building wing on the left houses the equipment room and that on the right houses Test Cell 8 (oxidizer) and the oxidizer storage pit or vault. - Air Force Plant PJKS, Systems Integration Laboratory, Components Test Laboratory, Waterton Canyon Road & Colorado Highway 121, Lakewood, Jefferson County, CO

3. Exterior view of Components Test Laboratory (T27), looking southeast. ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

3. Exterior view of Components Test Laboratory (T-27), looking southeast. The building wing on the left houses the equipment room, and that on the right houses Test Cell 8 (oxidizer) and the oxidizer storage pit or vault. - Air Force Plant PJKS, Systems Integration Laboratory, Components Test Laboratory, Waterton Canyon Road & Colorado Highway 121, Lakewood, Jefferson County, CO

Parachute Testing for Mars Science Laboratory

NASA Image and Video Library

2007-12-20

The team developing the landing system for NASA Mars Science Laboratory tested the deployment of an early parachute design in mid-October 2007 inside the world largest wind tunnel, at NASA Ames Research Center, Moffett Field, California.

Airborne Proximity Warning Instrument Laboratory Tests

DOT National Transportation Integrated Search

1977-01-01

An Airborne Proximity Warning Instrument (APWI) designed and manufactured by Rock Avionics, New York, was subjected to a short laboratory test at the Transportation Systems Center to determine the suitability of this product for further evaluation as...

Sequence variant classification and reporting: recommendations for improving the interpretation of cancer susceptibility genetic test results

PubMed Central

Plon, Sharon E.; Eccles, Diana M.; Easton, Douglas; Foulkes, William D.; Genuardi, Maurizio; Greenblatt, Marc S.; Hogervorst, Frans B.L.; Hoogerbrugge, Nicoline; Spurdle, Amanda B.; Tavtigian, Sean

2011-01-01

Genetic testing of cancer susceptibility genes is now widely applied in clinical practice to predict risk of developing cancer. In general, sequence-based testing of germline DNA is used to determine whether an individual carries a change that is clearly likely to disrupt normal gene function. Genetic testing may detect changes that are clearly pathogenic, clearly neutral or variants of unclear clinical significance. Such variants present a considerable challenge to the diagnostic laboratory and the receiving clinician in terms of interpretation and clear presentation of the implications of the result to the patient. There does not appear to be a consistent approach to interpreting and reporting the clinical significance of variants either among genes or among laboratories. The potential for confusion among clinicians and patients is considerable and misinterpretation may lead to inappropriate clinical consequences. In this article we review the current state of sequence-based genetic testing, describe other standardized reporting systems used in oncology and propose a standardized classification system for application to sequence based results for cancer predisposition genes. We suggest a system of five classes of variants based on the degree of likelihood of pathogenicity. Each class is associated with specific recommendations for clinical management of at-risk relatives that will depend on the syndrome. We propose that panels of experts on each cancer predisposition syndrome facilitate the classification scheme and designate appropriate surveillance and cancer management guidelines. The international adoption of a standardized reporting system should improve the clinical utility of sequence-based genetic tests to predict cancer risk. PMID:18951446

Hanford waste-form release and sediment interaction: A status report with rationale and recommendations for additional studies

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

Serne, R.J.; Wood, M.I.

1990-05-01

This report documents the currently available geochemical data base for release and retardation for actual Hanford Site materials (wastes and/or sediments). The report also recommends specific laboratory tests and presents the rationale for the recommendations. The purpose of this document is threefold: to summarize currently available information, to provide a strategy for generating additional data, and to provide recommendations on specific data collection methods and tests matrices. This report outlines a data collection approach that relies on feedback from performance analyses to ascertain when adequate data have been collected. The data collection scheme emphasizes laboratory testing based on empiricism. 196more » refs., 4 figs., 36 tabs.« less

Are laboratory tests always needed? Frequency and causes of laboratory overuse in a hospital setting.

PubMed

Cadamuro, Janne; Gaksch, Martin; Wiedemann, Helmut; Lippi, Giuseppe; von Meyer, Alexander; Pertersmann, Astrid; Auer, Simon; Mrazek, Cornelia; Kipman, Ulrike; Felder, Thomas K; Oberkofler, Hannes; Haschke-Becher, Elisabeth

2018-04-01

Inappropriate utilization of laboratory resources is an increasing concern especially in high-throughput facilities. Until now, no reliable information has been published addressing to which extent laboratory results are actually used for clinical decision-making. Therefore, we aimed to close this gap using a novel retrospective approach including a survey of clinicians and nurses. We retrospectively evaluated the number of re-orders for potassium (K), lactate dehydrogenase (LD), aspartate-aminotransferase (AST), activated partial thromboplastin-time (APTT) and prothrombin-time/INR (PT/INR), after the initial order had to be cancelled due to preanalytical non-conformities. We analyzed subgroups regarding time to re-order, ward and sample priority (urgent vs. routine). Subsequently, we surveyed clinicians and nurses, asking for their estimate of the amount of failed re-orders as well as for possible reasons. From initially cancelled tests, only ~20% of K, LD, AST and ~30% of APTT and PT/INR tests were re-ordered within 24 h. 70% of the investigated clinical chemistry and 60% of coagulation tests were re-ordered one week after cancellation or not at all. Survey participants quite accurately estimated these numbers. Routine laboratory panels, short stay of out-patients, obsolete test results and avoiding additional phlebotomies were the main reasons for not re-ordering cancelled tests. Overall, 60-70% of test results in the investigated assays ordered in a high throughput laboratory are potentially inappropriate or of doubtful clinically importance. Although clinicians and nurses are aware of this situation, it is the duty of laboratory specialists to overcome overutilization in close collaboration with all involved healthcare workers. Copyright © 2018 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Towards a rational antimicrobial testing policy in the laboratory.

PubMed

Banaji, N; Oommen, S

2011-01-01

Antimicrobial policy for prophylactic and therapeutic use of antimicrobials in a tertiary care setting has gained importance. A hospital's antimicrobial policy as laid down by its hospital infection control team needs to include inputs from the microbiology laboratory, besides the pharmacy and therapeutic committee. Therefore, it is of utmost importance that clinical microbiologists across India follow international guidelines and also take into account local settings, especially detection and presence of resistance enzymes. This article draws a framework for rational antimicrobial testing in our laboratories in tertiary care centers, from the Clinical and Laboratory Standards Institute guidelines. It does not address testing methodologies but suggests ways and means by which antimicrobial susceptibility reporting can be rendered meaningful not only to the treating physician but also to the resistance monitoring epidemiologist. It hopes to initiate some standardization in rational choice of antimicrobial testing in laboratories in the country pertaining to nonfastidious bacteria.

7. Exterior view of Components Test Laboratory (T27), looking south. ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

7. Exterior view of Components Test Laboratory (T-27), looking south. The wing in the immediate foreground houses the equipment room. - Air Force Plant PJKS, Systems Integration Laboratory, Components Test Laboratory, Waterton Canyon Road & Colorado Highway 121, Lakewood, Jefferson County, CO

Diagnosis of canine hypothyroidism. Perspectives from a testing laboratory.

PubMed

Kemppainen, R J; Behrend, E N

2001-09-01

The most common sample received by our endocrine testing laboratory is submitted for the diagnosis of hypothyroidism in a dog. The current tests most frequently employed in our laboratory for thyroid evaluation in dogs are total T4, free T4 by dialysis, and canine TSH measurement. Each test has strengths and weaknesses and suffers from the possibility of both false positive and false negative results. This article provides a working description of each test and an approach to interpretation of results. Other tests that are less commonly used are also discussed. Examples of interpretation of test results in individual hypothyroid-suspect dogs are presented for illustration.

49 CFR 40.81 - What laboratories may be used for DOT drug testing?

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 1 2011-10-01 2011-10-01 false What laboratories may be used for DOT drug testing... TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.81 What laboratories may be used for DOT drug testing? (a) As a drug testing laboratory located in the U.S., you are...

49 CFR 40.81 - What laboratories may be used for DOT drug testing?

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 1 2012-10-01 2012-10-01 false What laboratories may be used for DOT drug testing... TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.81 What laboratories may be used for DOT drug testing? (a) As a drug testing laboratory located in the U.S., you are...

49 CFR 40.81 - What laboratories may be used for DOT drug testing?

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 1 2014-10-01 2014-10-01 false What laboratories may be used for DOT drug testing... TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.81 What laboratories may be used for DOT drug testing? (a) As a drug testing laboratory located in the U.S., you are...

49 CFR 40.81 - What laboratories may be used for DOT drug testing?

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 1 2013-10-01 2013-10-01 false What laboratories may be used for DOT drug testing... TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.81 What laboratories may be used for DOT drug testing? (a) As a drug testing laboratory located in the U.S., you are...

49 CFR 40.81 - What laboratories may be used for DOT drug testing?

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 1 2010-10-01 2010-10-01 false What laboratories may be used for DOT drug testing... TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.81 What laboratories may be used for DOT drug testing? (a) As a drug testing laboratory located in the U.S., you are...

NASA Glenn's Acoustical Testing Laboratory Awarded Accreditation by the National Voluntary Laboratory Accreditation Program

NASA Technical Reports Server (NTRS)

Akers, James C.; Cooper, Beth A.

2004-01-01

NASA Glenn Research Center's Acoustical Testing Laboratory (ATL) provides a comprehensive array of acoustical testing services, including sound pressure level, sound intensity level, and sound-power-level testing per International Standards Organization (ISO)1 3744. Since its establishment in September 2000, the ATL has provided acoustic emission testing and noise control services for a variety of customers, particularly microgravity space flight hardware that must meet International Space Station acoustic emission requirements. The ATL consists of a 23- by 27- by 20-ft (height) convertible hemi/anechoic test chamber and a separate sound-attenuating test support enclosure. The ATL employs a personal-computer-based data acquisition system that provides up to 26 channels of simultaneous data acquisition with real-time analysis (ref. 4). Specialized diagnostic tools, including a scanning sound-intensity system, allow the ATL's technical staff to support its clients' aggressive low-noise design efforts to meet the space station's acoustic emission requirement. From its inception, the ATL has pursued the goal of developing a comprehensive ISO 17025-compliant quality program that would incorporate Glenn's existing ISO 9000 quality system policies as well as ATL-specific technical policies and procedures. In March 2003, the ATL quality program was awarded accreditation by the National Voluntary Laboratory Accreditation Program (NVLAP) for sound-power-level testing in accordance with ISO 3744. The NVLAP program is administered by the National Institutes of Standards and Technology (NIST) of the U.S. Department of Commerce and provides third-party accreditation for testing and calibration laboratories. There are currently 24 NVLAP-accredited acoustical testing laboratories in the United States. NVLAP accreditation covering one or more specific testing procedures conducted in accordance with established test standards is awarded upon successful completion of an intensive

7 CFR 3300.91 - List of approved testing stations, approved testing laboratories, and fees for certificates.

Code of Federal Regulations, 2010 CFR

2010-01-01

... CARRIAGE OF PERISHABLE FOODSTUFFS AND ON THE SPECIAL EQUIPMENT TO BE USED FOR SUCH CARRIAGE (ATP... testing stations, approved testing laboratories, and fees for certificates. A current list of U.S. ATP testing stations, U.S. ATP testing laboratories, and fees for issuance of U.S. ATP certificates may be...

7 CFR 3300.91 - List of approved testing stations, approved testing laboratories, and fees for certificates.

Code of Federal Regulations, 2013 CFR

2013-01-01

... CARRIAGE OF PERISHABLE FOODSTUFFS AND ON THE SPECIAL EQUIPMENT TO BE USED FOR SUCH CARRIAGE (ATP... testing stations, approved testing laboratories, and fees for certificates. A current list of U.S. ATP testing stations, U.S. ATP testing laboratories, and fees for issuance of U.S. ATP certificates may be...

7 CFR 3300.91 - List of approved testing stations, approved testing laboratories, and fees for certificates.

Code of Federal Regulations, 2012 CFR

2012-01-01

... CARRIAGE OF PERISHABLE FOODSTUFFS AND ON THE SPECIAL EQUIPMENT TO BE USED FOR SUCH CARRIAGE (ATP... testing stations, approved testing laboratories, and fees for certificates. A current list of U.S. ATP testing stations, U.S. ATP testing laboratories, and fees for issuance of U.S. ATP certificates may be...

7 CFR 3300.91 - List of approved testing stations, approved testing laboratories, and fees for certificates.

Code of Federal Regulations, 2014 CFR

2014-01-01

... CARRIAGE OF PERISHABLE FOODSTUFFS AND ON THE SPECIAL EQUIPMENT TO BE USED FOR SUCH CARRIAGE (ATP... testing stations, approved testing laboratories, and fees for certificates. A current list of U.S. ATP testing stations, U.S. ATP testing laboratories, and fees for issuance of U.S. ATP certificates may be...

7 CFR 3300.91 - List of approved testing stations, approved testing laboratories, and fees for certificates.

Code of Federal Regulations, 2011 CFR

2011-01-01

... CARRIAGE OF PERISHABLE FOODSTUFFS AND ON THE SPECIAL EQUIPMENT TO BE USED FOR SUCH CARRIAGE (ATP... testing stations, approved testing laboratories, and fees for certificates. A current list of U.S. ATP testing stations, U.S. ATP testing laboratories, and fees for issuance of U.S. ATP certificates may be...

Financial incentives and the supply of laboratory tests.

PubMed

Carlsen, Fredrik; Grytten, Jostein; Skau, Irene

2003-11-01

This study examined how the number of laboratory tests taken by a sample of Norwegian contract physicians is influenced by their private economy outside of the practice and by changes in remuneration. The data are drawn from 40,000 consultations carried out by 44 contract physicians in 1991-1994. Two factors which led to changes in the level of physicians' income are considered: changes in remuneration for consultations and laboratory tests and changes in interest rates on loans and bank deposits. The effect which changes in interest rates have on physicians' disposable income was calculated using information about their financial assets and debts obtained from tax assessments. The main finding was that changes in private economy and changes in remuneration have no or only a small effect on the number of laboratory tests taken. Our results suggest that fee regulation can be an effective means of controlling physicians' income and therefore government expenditure on primary physician services.

The Tanzania experience: clinical laboratory testing harmonization and equipment standardization at different levels of a tiered health laboratory system.

PubMed

Massambu, Charles; Mwangi, Christina

2009-06-01

The rapid scale-up of the care and treatment programs in Tanzania during the preceding 4 years has greatly increased the demand for quality laboratory services for diagnosis of HIV and monitoring patients during antiretroviral therapy. Laboratory services were not in a position to cope with this demand owing to poor infrastructure, lack of human resources, erratic and/or lack of reagent supply and commodities, and slow manual technologies. With the limited human resources in the laboratory and the need for scaling up the care and treatment program, it became necessary to install automated equipment and train personnel for the increased volume of testing and new tests across all laboratory levels. With the numerous partners procuring equipment, the possibility of a multitude of equipment platforms with attendant challenges for procurement of reagents, maintenance of equipment, and quality assurance arose. Tanzania, therefore, had to harmonize laboratory tests and standardize laboratory equipment at different levels of the laboratory network. The process of harmonization of tests and standardization of equipment included assessment of laboratories, review of guidelines, development of a national laboratory operational plan, and stakeholder advocacy. This document outlines this process.

Quality assurance of laboratory work and clinical use of laboratory tests in general practice in norway: a survey.

PubMed

Thue, Geir; Jevnaker, Marianne; Gulstad, Guri Andersen; Sandberg, Sverre

2011-09-01

Virtually all the general practices in Norway participate in the Norwegian Quality Improvement of Laboratory Services in Primary Care, NOKLUS. In order to assess and develop NOKLUS's services, it was decided to carry out an investigation in the largest participating group, general practices. In autumn 2008 a questionnaire was sent to all Norwegian general practices asking for feedback on different aspects of NOKLUS's main services: contact with medical laboratory technologists, sending of control materials, use and maintenance of practice-specific laboratory binders, courses, and testing of laboratory equipment. In addition, attitudes were elicited towards possible new services directed at assessing other technical equipment and clinical use of tests. Responses were received from 1290 of 1552 practices (83%). The great majority thought that the frequency of sending out control material should continue as at present, and they were pleased with the feedback reports and follow-up by the laboratory technologists in the counties. Even after many years of practical experience, there is still a need to update laboratory knowledge through visits to practices, courses, and written information. Practices also wanted quality assurance of blood pressure meters and spirometers, and many doctors wanted feedback on their use of laboratory tests. Services regarding quality assurance of point-of-care tests, guidance, and courses should be continued. Quality assurance of other technical equipment and of the doctor's clinical use of laboratory tests should be established as part of comprehensive quality assurance.

Automated cognitive testing of monkeys in social groups yields results comparable to individual laboratory-based testing.

PubMed

Gazes, Regina Paxton; Brown, Emily Kathryn; Basile, Benjamin M; Hampton, Robert R

2013-05-01

Cognitive abilities likely evolved in response to specific environmental and social challenges and are therefore expected to be specialized for the life history of each species. Specialized cognitive abilities may be most readily engaged under conditions that approximate the natural environment of the species being studied. While naturalistic environments might therefore have advantages over laboratory settings for cognitive research, it is difficult to conduct certain types of cognitive tests in these settings. We implemented methods for automated cognitive testing of monkeys (Macaca mulatta) in large social groups (Field station) and compared the performance to that of laboratory-housed monkeys (Laboratory). The Field station animals shared access to four touch-screen computers in a large naturalistic social group. Each Field station subject had an RFID chip implanted in each arm for computerized identification and individualized assignment of cognitive tests. The Laboratory group was housed and tested in a typical laboratory setting, with individual access to testing computers in their home cages. Monkeys in both groups voluntarily participated at their own pace for food rewards. We evaluated performance in two visual psychophysics tests, a perceptual classification test, a transitive inference test, and a delayed matching-to-sample memory test. Despite the differences in housing, social environment, age, and sex, monkeys in the two groups performed similarly in all tests. Semi-free ranging monkeys living in complex social environments are therefore viable subjects for cognitive testing designed to take advantage of the unique affordances of naturalistic testing environments.

Automated cognitive testing of monkeys in social groups yields results comparable to individual laboratory based testing

PubMed Central

Gazes, Regina Paxton; Brown, Emily Kathryn; Basile, Benjamin M.; Hampton, Robert R.

2013-01-01

Cognitive abilities likely evolved in response to specific environmental and social challenges and are therefore expected to be specialized for the life history of each species. Specialized cognitive abilities may be most readily engaged under conditions that approximate the natural environment of the species being studied. While naturalistic environments might therefore have advantages over laboratory settings for cognitive research, it is difficult to conduct certain types of cognitive tests in these settings. We implemented methods for automated cognitive testing of monkeys (Macaca mulatta) in large social groups (Field station) and compared the performance to that of laboratory housed monkeys (Laboratory). The Field station animals shared access to four touch screen computers in a large naturalistic social group. Each Field station subject had an RFID chip implanted in each arm for computerized identification and individualized assignment of cognitive tests. The Laboratory group was housed and tested in a typical laboratory setting, with individual access to testing computers in their home cages. Monkeys in both groups voluntarily participated at their own pace for food rewards. We evaluated performance in two visual psychophysics tests, a perceptual classification test, a transitive inference test, and a delayed matching to sample memory test. Despite differences in housing, social environment, age, and sex, monkeys in the two groups performed similarly in all tests. Semi-free ranging monkeys living in complex social environments are therefore viable subjects for cognitive testing designed to take advantage of the unique affordances of naturalistic testing environments. PMID:23263675

The Illinois Articulation Initiative Major Fields Panels' Recommendations for Business, Clinical Laboratory Science, Education--Early Childhood, Education--Elementary, Education--Secondary, Music, Nursing, Psychology.

ERIC Educational Resources Information Center

Illinois Community Coll. Board, Springfield.

Developed by the Illinois Articulation Initiative (IAI), this report provides recommendations for improving articulation through state high schools, community colleges, and institutions of higher education. The recommendations are presented by field of study for business, clinical laboratory science, early childhood education, elementary…

Laboratory testing of GNB switch 12 volt SLI (starting, lighting and ignition) battery

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

Hardin, J.E.

1990-03-01

The purpose of this report is to describe the testing performed on the GNB Switch flooded lead SLI battery in the INEL Electric Vehicle Battery Laboratory, to present the results and conclusions of this testing, and to make appropriate recommendations. GNB Inc. is a Pacific Dunlop Company. The term SWITCH'' comes from the fact that this product consists of two batteries in one package which can be connected in parallel by a switch for higher cranking energy or reserve capacity. The smaller second battery is float charged through a diode. GNB advertising describes the SWITCH'' as The Battery With Amore » Spare''. The Switch, a BCI Group 24 SLI (Starting, Lighting and Ignition) battery, is manufactured in Georgia for sale throughout the US. The initial design work on the Switch was done in Australia under the Pulsar name by Dunlop. 11 figs., 3 tabs.« less

9 CFR 590.580 - Laboratory tests and analyses.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Laboratory tests and analyses. 590.580 Section 590.580 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... sequence, frequency, and approved laboratory methods as prescribed by the AMS Science Division Director...

9 CFR 590.580 - Laboratory tests and analyses.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Laboratory tests and analyses. 590.580 Section 590.580 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... sequence, frequency, and approved laboratory methods as prescribed by the AMS Science Division Director...

9 CFR 590.580 - Laboratory tests and analyses.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Laboratory tests and analyses. 590.580 Section 590.580 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... sequence, frequency, and approved laboratory methods as prescribed by the AMS Science Division Director...

Laboratory hemostasis: milestones in Clinical Chemistry and Laboratory Medicine.

PubMed

Lippi, Giuseppe; Favaloro, Emmanuel J

2013-01-01

Hemostasis is a delicate, dynamic and intricate system, in which pro- and anti-coagulant forces cooperate for either maintaining blood fluidity under normal conditions, or else will prompt blood clot generation to limit the bleeding when the integrity of blood vessels is jeopardized. Excessive prevalence of anticoagulant forces leads to hemorrhage, whereas excessive activation of procoagulant forces triggers excessive coagulation and thrombosis. The hemostasis laboratory performs a variety of first, second and third line tests, and plays a pivotal role in diagnostic and monitoring of most hemostasis disturbances. Since the leading targets of Clinical Chemistry and Laboratory Medicine include promotion of progress in fundamental and applied research, along with publication of guidelines and recommendations in laboratory diagnostics, this journal is an ideal source of information on current developments in the laboratory technology of hemostasis, and this article is aimed to celebrate some of the most important and popular articles ever published by the journal in the filed of laboratory hemostasis.

Exploration of task performance tests in a physics laboratory

NASA Astrophysics Data System (ADS)

Liu, Dan; El Turkey, Houssein

2017-11-01

In this article, we investigate the implementation of task performance tests in an undergraduate physics laboratory. Two performance tests were carried out over two semesters using the task of building a DC circuit. The first implementation in Spring 2014 had certain concerns such as the privacy of students’ testing and their ‘trial and error’ attempts. These concerns were addressed in Fall 2015 through implementing a second performance test. The second implementation was administered differently but the content of the two tests was the same. We discuss the validity of both implementations and present the correlation (or lack of) between the time that students needed to complete the tests and their grades from a paper-based laboratory assessment method.

Triage and protocol recommendations for the parasitology laboratory based on an epidemiological investigation of parasite diagnostics in Ontario laboratories

PubMed Central

Maier, Allison; Krolik, Julia; Majury, Anna

2014-01-01

OBJECTIVES: A study was performed using a subset of Ontario laboratory parasitology data, with three objectives: to describe parasitic infections in Ontario; to identify risk factors for acquiring a parasitic infection using routinely collected information; and to use this information to assess current protocols for parasite testing in laboratories and, in turn, to propose alternatives to optimize the allocation of laboratory resources. METHODS: All parasitology records from January 4, 2010 to September 14, 2010 were reviewed descriptively and risk factor analyses were performed using information collected from requisitions. These results were used to develop preliminary alternative protocols, which considered high-throughput screening tests and inclusion/exclusion criteria for ova and parasite testing; these were then retrospectively analyzed with the dataset to determine appropriateness. RESULTS: Of the 29,260 records analyzed, 10% were multiple samples from single patients submitted on the same day, of which 98% had the same result. Three percent of all parasite tests were positive, with the most prevalent parasites being (in ascending order) Dientamoeba fragilis, Giardia lamblia, Cryptosporidium species and Entamoeba histolytica/dispar. Age and sex were found to be weak risk factors, while rural living was found to be a moderate risk factor for D fragilis, G lamblia and Cryptosporidium infections. The strongest risk factor was travel history, especially for nonendemic parasites. The retrospective analysis of six alternative protocols identified four that may be more efficient than current procedures. CONCLUSIONS: The present study demonstrated that current protocols may be redundant and can be optimized to target prevalent parasites and populations with high risk factors. PMID:25587292

Inter-laboratory trial of a standardized sediment contact test with the aquatic plant Myriophyllum aquaticum (ISO 16191).

PubMed

Feiler, Ute; Ratte, Monika; Arts, Gertie; Bazin, Christine; Brauer, Frank; Casado, Carmen; Dören, Laszlo; Eklund, Britta; Gilberg, Daniel; Grote, Matthias; Gonsior, Guido; Hafner, Christoph; Kopf, Willi; Lemnitzer, Bernd; Liedtke, Anja; Matthias, Uwe; Okos, Ewa; Pandard, Pascal; Scheerbaum, Dirk; Schmitt-Jansen, Mechthild; Stewart, Kathleen; Teodorovic, Ivana; Wenzel, Andrea; Pluta, Hans-Jürgen

2014-03-01

A whole-sediment toxicity test with Myriophyllum aquaticum has been developed by the German Federal Institute of Hydrology and standardized within the International Organization for Standardization (ISO; ISO 16191). An international ring-test was performed to evaluate the precision of the test method. Four sediments (artificial, natural) were tested. Test duration was 10 d, and test endpoint was inhibition of growth rate (r) based on fresh weight data. Eighteen of 21 laboratories met the validity criterion of r ≥ 0.09 d(-1) in the control. Results from 4 tests that did not conform to test-performance criteria were excluded from statistical evaluation. The inter-laboratory variability of growth rates (20.6%-25.0%) and inhibition (26.6%-39.9%) was comparable with the variability of other standardized bioassays. The mean test-internal variability of the controls was low (7% [control], 9.7% [solvent control]), yielding a high discriminatory power of the given test design (median minimum detectable differences [MDD] 13% to 15%). To ensure these MDDs, an additional validity criterion of CV ≤ 15% of the growth rate in the controls was recommended. As a positive control, 90 mg 3,5-dichlorophenol/kg sediment dry mass was tested. The range of the expected growth inhibition was proposed to be 35 ± 15%. The ring test results demonstrated the reliability of the ISO 16191 toxicity test and its suitability as a tool to assess the toxicity of sediment and dredged material. © 2013 SETAC.

Diagnosing acute HIV infection: The performance of quantitative HIV-1 RNA testing (viral load) in the 2014 laboratory testing algorithm.

PubMed

Wu, Hsiu; Cohen, Stephanie E; Westheimer, Emily; Gay, Cynthia L; Hall, Laura; Rose, Charles; Hightow-Weidman, Lisa B; Gose, Severin; Fu, Jie; Peters, Philip J

2017-08-01

New recommendations for laboratory diagnosis of HIV infection in the United States were published in 2014. The updated testing algorithm includes a qualitative HIV-1 RNA assay to resolve discordant immunoassay results and to identify acute HIV-1 infection (AHI). The qualitative HIV-1 RNA assay is not widely available; therefore, we evaluated the performance of a more widely available quantitative HIV-1 RNA assay, viral load, for diagnosing AHI. We determined that quantitative viral loads consistently distinguished AHI from a false-positive immunoassay result. Among 100 study participants with AHI and a viral load result, the estimated geometric mean viral load was 1,377,793copies/mL. Copyright © 2017 Elsevier B.V. All rights reserved.

49 CFR 40.99 - How long does the laboratory retain specimens after testing?

Code of Federal Regulations, 2012 CFR

2012-10-01

... after testing? 40.99 Section 40.99 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.99 How long does the laboratory retain specimens after testing? (a) As a laboratory testing the primary...

49 CFR 40.99 - How long does the laboratory retain specimens after testing?

Code of Federal Regulations, 2011 CFR

2011-10-01

... after testing? 40.99 Section 40.99 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.99 How long does the laboratory retain specimens after testing? (a) As a laboratory testing the primary...

49 CFR 40.99 - How long does the laboratory retain specimens after testing?

Code of Federal Regulations, 2013 CFR

2013-10-01

... after testing? 40.99 Section 40.99 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.99 How long does the laboratory retain specimens after testing? (a) As a laboratory testing the primary...

49 CFR 40.99 - How long does the laboratory retain specimens after testing?

Code of Federal Regulations, 2014 CFR

2014-10-01

... after testing? 40.99 Section 40.99 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.99 How long does the laboratory retain specimens after testing? (a) As a laboratory testing the primary...

49 CFR 40.99 - How long does the laboratory retain specimens after testing?

Code of Federal Regulations, 2010 CFR

2010-10-01

... after testing? 40.99 Section 40.99 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.99 How long does the laboratory retain specimens after testing? (a) As a laboratory testing the primary...

Use of laboratory testing for genital chlamydial infection in Norway.

PubMed Central

Aavitsland, P

1993-01-01

OBJECTIVE--To assess the use of laboratory tests for genital chlamydial infection in Norway. DESIGN--Questionnaire survey of general practitioners' practice in chlamydial testing, retrospective survey of laboratory records, 1986-91, and prospective study of testing in one laboratory during four weeks. SETTING--All 18 microbiological laboratories in Norway (4.2 million population), including one serving all doctors in Vestfold county (0.2 million population). SUBJECTS--302 general practitioners. MAIN MEASURES--GPs' routine practice, methods used for testing, 1986-91, and sex specific and age group specific testing in 1991. RESULTS--201(69%) GPs replied to the questionnaire: 101(51%) would test all women younger than 25 years at routine pelvic examination, 107(54%) all girls at first pelvic examination, 131(66%) all pregnant women, and 106(54%) all men whose female partner had urogenital complaints. Nationwide in 1986, 122,000 tests were performed (2.9 per 100 population); 10% were positive and 51% were cell culture tests. In 1991, 341,000 tests were performed (8.0 per 100 population); 4.5% were positive and 15% were cell culture tests. 13,184 tests were performed in Vestfold in 1991 (6.6 per 100 population). The age group specific rates (per 100 population) among women were: age 15-19 years, 22.0(95% confidence interval 18.2 to 25.8); 20-24 years, 47.2(42.1 to 52.3); 25-29 years, 42.3(37.1 to 47.5); 30-34 years, 29.8(25.4 to 34.2); and 35-39 years, 12.5(9.5 to 15.5). CONCLUSIONS--GPs use liberal indications for testing. The dramatic increase in testing, especially by enzyme immunoassays, in populations with a low prevalence of infection results in low cost effectiveness and low predictive value of positive tests, which in women over 29 years is estimated as 17-36%. IMPLICATIONS--Doctors should be educated about the limitations of enzyme immunoassays in screening low prevalence populations, and laboratories should apply a confirmatory test to specimens testing

Laboratory Testing Protocols for Heparin-Induced Thrombocytopenia (HIT) Testing.

PubMed

Lau, Kun Kan Edwin; Mohammed, Soma; Pasalic, Leonardo; Favaloro, Emmanuel J

2017-01-01

Heparin-induced thrombocytopenia (HIT) represents a significant high morbidity complication of heparin therapy. The clinicopathological diagnosis of HIT remains challenging for many reasons; thus, laboratory testing represents an important component of an accurate diagnosis. Although there are many assays available to assess HIT, these essentially fall into two categories-(a) immunological assays, and (b) functional assays. The current chapter presents protocols for several HIT assays, being those that are most commonly performed in laboratory practice and have the widest geographic distribution. These comprise a manual lateral flow-based system (STiC), a fully automated latex immunoturbidimetric assay, a fully automated chemiluminescent assay (CLIA), light transmission aggregation (LTA), and whole blood aggregation (Multiplate).

Constrained Laboratory vs. Unconstrained Steering-Induced Rollover Crash Tests.

PubMed

Kerrigan, Jason R; Toczyski, Jacek; Roberts, Carolyn; Zhang, Qi; Clauser, Mark

2015-01-01

The goal of this study was to evaluate how well an in-laboratory rollover crash test methodology that constrains vehicle motion can reproduce the dynamics of unconstrained full-scale steering-induced rollover crash tests in sand. Data from previously-published unconstrained steering-induced rollover crash tests using a full-size pickup and mid-sized sedan were analyzed to determine vehicle-to-ground impact conditions and kinematic response of the vehicles throughout the tests. Then, a pair of replicate vehicles were prepared to match the inertial properties of the steering-induced test vehicles and configured to record dynamic roof structure deformations and kinematic response. Both vehicles experienced greater increases in roll-axis angular velocities in the unconstrained tests than in the constrained tests; however, the increases that occurred during the trailing side roof interaction were nearly identical between tests for both vehicles. Both vehicles experienced linear accelerations in the constrained tests that were similar to those in the unconstrained tests, but the pickup, in particular, had accelerations that were matched in magnitude, timing, and duration very closely between the two test types. Deformations in the truck test were higher in the constrained than the unconstrained, and deformations in the sedan were greater in the unconstrained than the constrained as a result of constraints of the test fixture, and differences in impact velocity for the trailing side. The results of the current study suggest that in-laboratory rollover tests can be used to simulate the injury-causing portions of unconstrained rollover crashes. To date, such a demonstration has not yet been published in the open literature. This study did, however, show that road surface can affect vehicle response in a way that may not be able to be mimicked in the laboratory. Lastly, this study showed that configuring the in-laboratory tests to match the leading-side touchdown conditions

Good Laboratory Practices of Materials Testing at NASA White Sands Test Facility

NASA Technical Reports Server (NTRS)

Hirsch, David; Williams, James H.

2005-01-01

An approach to good laboratory practices of materials testing at NASA White Sands Test Facility is presented. The contents include: 1) Current approach; 2) Data analysis; and 3) Improvements sought by WSTF to enhance the diagnostic capability of existing methods.

42 CFR 493.1421 - Condition: Laboratories performing moderate complexity testing; testing personnel.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Condition: Laboratories performing moderate complexity testing; testing personnel. 493.1421 Section 493.1421 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION...

42 CFR 493.1421 - Condition: Laboratories performing moderate complexity testing; testing personnel.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Condition: Laboratories performing moderate complexity testing; testing personnel. 493.1421 Section 493.1421 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION...

Syphilis testing in antenatal care: Policies and practices among laboratories in the Americas.

PubMed

Luu, Minh; Ham, Cal; Kamb, Mary L; Caffe, Sonja; Hoover, Karen W; Perez, Freddy

2015-06-01

To asses laboratory syphilis testing policies and practices among laboratories in the Americas. Laboratory directors or designees from PAHO member countries were invited to participate in a structured, electronically-delivered survey between March and August, 2014. Data on syphilis tests, algorithms, and quality control (QC) practices were analyzed, focusing on laboratories receiving specimens from antenatal clinics (ANCs). Surveys were completed by 69 laboratories representing 30 (86%) countries. Participating laboratories included 36 (52%) national or regional reference labs and 33 (48%) lower-level laboratories. Most (94%) were public sector facilities and 71% reported existence of a national algorithm for syphilis testing in pregnancy, usually involving both treponemal and non-treponemal testing (72%). Less than half (41%) used rapid syphilis tests (RSTs); and only seven laboratories representing five countries reported RSTs were included in the national algorithm for pregnant women. Most (83%) laboratories serving ANCs reported using some type of QC system; 68% of laboratories reported participation in external QC. Only 36% of laboratories reported data to national/local surveillance. Half of all laboratories serving ANC settings reported a stockout of one or more essential supplies during the previous year (median duration, 30days). Updating laboratory algorithms, improving testing standards, integrating data into existing surveillance, and improved procurement and distribution of commodities may be needed to ensure elimination of MTCT of syphilis in the Americas. Copyright © 2015. Published by Elsevier Ireland Ltd.

Comparison of results of fluconazole disk diffusion testing for Candida species with results from a central reference laboratory in the ARTEMIS global antifungal surveillance program.

PubMed

Pfaller, M A; Hazen, K C; Messer, S A; Boyken, L; Tendolkar, S; Hollis, R J; Diekema, D J

2004-08-01

The accuracy of antifungal susceptibility tests is important for accurate resistance surveillance and for the clinical management of patients with serious infections. Our main objective was to compare the results of fluconazole disk diffusion testing of Candida spp. performed by ARTEMIS participating centers with disk diffusion and MIC results obtained by the central reference laboratory. A total of 2,949 isolates of Candida spp. were tested by NCCLS disk diffusion and reference broth microdilution methods in the central reference laboratory. These results were compared to the results of disk diffusion testing performed in the 54 participating centers. All tests were performed and interpreted following NCCLS recommendations. Overall categorical agreement between participant disk diffusion test results and reference laboratory MIC results was 87.4%, with 0.2% very major errors (VME) and 3.3% major errors (ME). The categorical agreement between the disk diffusion test results obtained in the reference laboratory with the MIC test results was similar: 92.8%. Likewise, good agreement was observed between participant disk diffusion test results and reference laboratory disk diffusion test results: 90.4%, 0.4% VME, and 3.4% ME. The disk diffusion test was especially reliable in detecting those isolates of Candida spp. that were characterized as resistant by reference MIC testing. External quality assurance data obtained by surveillance programs such as the ARTEMIS Global Antifungal Surveillance Program ensure the generation of useful surveillance data and result in the continued improvement of antifungal susceptibility testing practices.

Security Considerations and Recommendations in Computer-Based Testing

PubMed Central

Al-Saleem, Saleh M.

2014-01-01

Many organizations and institutions around the globe are moving or planning to move their paper-and-pencil based testing to computer-based testing (CBT). However, this conversion will not be the best option for all kinds of exams and it will require significant resources. These resources may include the preparation of item banks, methods for test delivery, procedures for test administration, and last but not least test security. Security aspects may include but are not limited to the identification and authentication of examinee, the risks that are associated with cheating on the exam, and the procedures related to test delivery to the examinee. This paper will mainly investigate the security considerations associated with CBT and will provide some recommendations for the security of these kinds of tests. We will also propose a palm-based biometric authentication system incorporated with basic authentication system (username/password) in order to check the identity and authenticity of the examinee. PMID:25254250

Security considerations and recommendations in computer-based testing.

PubMed

Al-Saleem, Saleh M; Ullah, Hanif

2014-01-01

Many organizations and institutions around the globe are moving or planning to move their paper-and-pencil based testing to computer-based testing (CBT). However, this conversion will not be the best option for all kinds of exams and it will require significant resources. These resources may include the preparation of item banks, methods for test delivery, procedures for test administration, and last but not least test security. Security aspects may include but are not limited to the identification and authentication of examinee, the risks that are associated with cheating on the exam, and the procedures related to test delivery to the examinee. This paper will mainly investigate the security considerations associated with CBT and will provide some recommendations for the security of these kinds of tests. We will also propose a palm-based biometric authentication system incorporated with basic authentication system (username/password) in order to check the identity and authenticity of the examinee.

[Point-of-care-testing--the intensive care laboratory].

PubMed

Müller, M M; Hackl, W; Griesmacher, A

1999-01-01

After successful centralization of laboratory analyses since more than 30 years, advances in biosensors, microprocessors, measurement of undiluted whole blood and miniaturization of laboratory analyzers are leading nowadays more and more to a re-decentralization in the laboratory medicine. Point-of-care-testing (POCT), which is defined as any laboratory test performed outside central or decentralized laboratories, is becoming more and more popular. The theoretical advantages of POCT are faster turn-around-times (TAT), more rapid medical decisions, avoidance of sample identification and sample transport problems and the need of only small specimen volumes. These advantages are frequently mentioned, but are not associated with a clear clinical benefit. The disadvantages of POCT such as incorrect handling and/or maintenance of the analyzers by nontrained clinical staff, inadequate or even absent calibrations and/or quality controls, lack of cost-effectiveness because of an increased number of analyzers and more expensive reagents, insufficient documentation and difficult comparability of the obtained POCT-results with routine laboratory results, are strongly evident. According to the authors' opinion the decision for the establishing of POCT has only to be made in a close co-operation between physicians and laboratorians in order to vouch for necessity and high quality of the analyses. Taking the local situation into consideration (24-h-central laboratory, etc.) the spectrum of parameters measured by means of POCT should be rigorously restricted to the vital functions. Such analytes should be: hemoglobin or hematocrit, activated whole blood clotting time, blood gases, sodium, potassium, ionized calcium, glucose, creatinine, ammonia and lactate.

7 CFR 75.43 - Laboratory testing.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 3 2013-01-01 2013-01-01 false Laboratory testing. 75.43 Section 75.43 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) REGULATIONS AND STANDARDS UNDER THE AGRICULTURAL MARKETING ACT OF 1946 AND THE...

Mars Science Laboratory Workstation Test Set

NASA Technical Reports Server (NTRS)

Henriquez, David A.; Canham, Timothy K.; Chang, Johnny T.; Villaume, Nathaniel

2009-01-01

The Mars Science Laboratory developed the Workstation TestSet (WSTS) is a computer program that enables flight software development on virtual MSL avionics. The WSTS is the non-real-time flight avionics simulator that is designed to be completely software-based and run on a workstation class Linux PC.

1. Exterior view of Components Test Laboratory (T27), looking southeast ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

1. Exterior view of Components Test Laboratory (T-27), looking southeast from hill north of structure. The building wing in the right foreground houses Test Cell 8 (oxidizer) and the oxidizer storage pit or vault. Test Cell 10 is located in the center background, Test Cell 9 is at the far left, and the equipment room is in the immediate left foreground. The control room is in the center of the structure and abuts the aforementioned test cell and equipment room wings. This structure served as a facility for testing, handling, and storage of Titan II's hydrazine- and nitrogen teteroxide-based propellant system components for compatability determinations. - Air Force Plant PJKS, Systems Integration Laboratory, Components Test Laboratory, Waterton Canyon Road & Colorado Highway 121, Lakewood, Jefferson County, CO

Recommendations for Filler Material Composition and Delivery Method for Bench-Scale Testing

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

Hardin, Ernest; Brady, Patrick Vane

This report supplements Joint Workplan on Filler Investigations for DPCs (SNL 2017) providing new and some corrected information for use in planning Phase 1 laboratory testing of slurry cements as possible DPC fillers. The scope description is to "Describe a complete laboratory testing program for filler composition, delivery, emplacement in surrogate canisters, and post-test examination. To the extent possible specify filler material and equipment sources." This report includes results from an independent expert review (Dr. Arun Wagh, retired from Argonne National Laboratory and contracted by Sandia) that helped to narrow the range of cement types for consideration, and to providemore » further guidance on mix variations to optimize injectability, durability, and other aspects of filler performance.« less

Laboratory testing of alcohol safety interlock systems employing divided attention tests

DOT National Transportation Integrated Search

1975-12-01

Author's abstract: Prototype Alcohol Safety Interlock Systems employing measurements of tracking ability, reaction time, and response accuracy to discern alcohol impairment were submitted to laboratory testing. These systems were modified versions of...

Electronics systems test laboratory testing of shuttle communications systems

NASA Technical Reports Server (NTRS)

Stoker, C. J.; Bromley, L. K.

1985-01-01

Shuttle communications and tracking systems space to space and space to ground compatibility and performance evaluations are conducted in the NASA Johnson Space Center Electronics Systems Test Laboratory (ESTL). This evaluation is accomplished through systems verification/certification tests using orbiter communications hardware in conjunction with other shuttle communications and tracking external elements to evaluate end to end system compatibility and to verify/certify that overall system performance meets program requirements before manned flight usage. In this role, the ESTL serves as a multielement major ground test facility. The ESTL capability and program concept are discussed. The system test philosophy for the complex communications channels is described in terms of the major phases. Results of space to space and space to ground systems tests are presented. Several examples of the ESTL's unique capabilities to locate and help resolve potential problems are discussed in detail.

Guidelines for the use and interpretation of nucleic acid detection tests for Neisseria gonorrhoeae in Australia: a position paper on behalf of the Public Health Laboratory Network.

PubMed

Smith, David W; Tapsall, John W; Lum, Gary

2005-01-01

The Public Health Laboratory Network (PHLN) convened a workshop of Australian experts in Melbourne on 23 March 2005 to identify laboratory issues of relevance and suggest guidelines for use of nucleic acid detection tests (NADT) for diagnosis of gonorrhoea in Australia. The proceedings of that meeting were endorsed by the members of the PHLN and the Communicable Diseases Network of Australia. Given the present state of knowledge and experience of conditions currently existing in Australia, the following recommendations were made: Recommendation 1: Assays using detection of the cppB gene should not be used for either screening or supplemental assays. Recommendation 2: All in-house screening assays that are positive should also be positive on a reliable supplemental assay before a positive result is reported. Recommendation 3: All commercial screening assays that are positive should also be positive on a reliable supplemental assay before a positive result is reported. Recommendation 4: If a sample is positive in a screening assay but a suitable supplemental assay is negative, then the result should be reported as negative. Recommendation 5: Laboratories should ensure that the test combination they use would yield a positive predictive value of at least 90 per cent in a population with a prevalence of 1 per cent. Recommendation 6: For the purposes of test evaluation, as distinct from diagnostic testing, true positives be defined by meeting one or more of the following criteria: 1) culture positive using contemporary isolation and identification techniques; 2) positive result on NADTs directed to targets on three separate genes that are known to have discriminatory capacity; 3) sequencing of a gene known to separate gonococcal from non-gonococcal species. Recommendation 7: Inhibitor controls should be routinely included in all NADT. Recommendation 8: Cultures are the preferred test for samples from non-genital sites. If however it is necessary to perform a NADT, then

FELASA recommendations for the health monitoring of mouse, rat, hamster, guinea pig and rabbit colonies in breeding and experimental units.

PubMed

Mähler Convenor, M; Berard, M; Feinstein, R; Gallagher, A; Illgen-Wilcke, B; Pritchett-Corning, K; Raspa, M

2014-07-01

The microbiological quality of experimental animals can critically influence animal welfare and the validity and reproducibility of research data. It is therefore important for breeding and experimental facilities to establish a laboratory animal health monitoring (HM) programme as an integrated part of any quality assurance system. FELASA has published recommendations for the HM of rodent and rabbit colonies in breeding and experimental units (Nicklas et al. Laboratory Animals, 2002), with the intention of harmonizing HM programmes. As stated in the preamble, these recommendations need to be adapted periodically to meet current developments in laboratory animal medicine. Accordingly, previous recommendations have been revised and shall be replaced by the present recommendations. These recommendations are aimed at all breeders and users of laboratory mice, rats, Syrian hamsters, guinea pigs and rabbits as well as diagnostic laboratories. They describe essential aspects of HM, such as the choice of agents, selection of animals and tissues for testing, frequency of sampling, commonly used test methods, interpretation of results and HM reporting. Compared with previous recommendations, more emphasis is put on the role of a person with sufficient understanding of the principles of HM, opportunistic agents, the use of sentinel animals (particularly under conditions of cage-level containment) and the interpretation and reporting of HM results. Relevant agents, testing frequencies and literature references are updated. Supplementary information on specific agents and the number of animals to be monitored and an example of a HM programme description is provided in the appendices. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

Long-term pavement performance project laboratory materials testing and handling guide

DOT National Transportation Integrated Search

2007-09-01

The Long Term Pavement Performance (LTPP) Laboratory Material Testing Guide was originally prepared for laboratory material handling and testing of material specimens and samples of asphalt materials, portland cement concrete, aggregates, and soils u...

Impact of external haematology proficiency testing programme on quality of laboratories.

PubMed

Saxena, Renu; Katoch, S C; Srinivas, Upendra; Rao, Seema; Anand, Hema

2007-11-01

A reliable and reproducible report from a laboratory needs internal quality control within the laboratory and participation in external proficiency testing programmes (EPTP). This study conducted at the Department of Haematology, All India Institute of Medical Sciences (AIIMS), New Delhi, which has been conducting an EPTP since 1992, was undertaken to assess the efficacy of this programme in improving the performance of participating laboratories in reporting test samples sent for Hb, total leucocyte count (TLC), reticulocyte count and assessment of peripheral blood smear (PBS). The samples were prepared in our laboratory according to the International Standards Organization (ISO) guidelines. The performance of individual laboratories was assessed using robust Z score, which is an indicator of acceptability of the test result. An improvement in the overall percentage of laboratories with acceptable reports was seen during the study period. It has increased from 38,40,40 per cent in 1992 to 85, 90,94.7 per cent in 2006 for Hb, TLC, reticulocyte count, respectively. However, the results for peripheral smear assessment improved only marginally. The external haematology proficiency testing programme run by our department for Hb, TLC, reticulocyte count, and peripheral blood smear assessment, has helped in improving the reporting standards of these parameters in Indian laboratories.

Performance Tested Method multiple laboratory validation study of ELISA-based assays for the detection of peanuts in food.

PubMed

Park, Douglas L; Coates, Scott; Brewer, Vickery A; Garber, Eric A E; Abouzied, Mohamed; Johnson, Kurt; Ritter, Bruce; McKenzie, Deborah

2005-01-01

Performance Tested Method multiple laboratory validations for the detection of peanut protein in 4 different food matrixes were conducted under the auspices of the AOAC Research Institute. In this blind study, 3 commercially available ELISA test kits were validated: Neogen Veratox for Peanut, R-Biopharm RIDASCREEN FAST Peanut, and Tepnel BioKits for Peanut Assay. The food matrixes used were breakfast cereal, cookies, ice cream, and milk chocolate spiked at 0 and 5 ppm peanut. Analyses of the samples were conducted by laboratories representing industry and international and U.S governmental agencies. All 3 commercial test kits successfully identified spiked and peanut-free samples. The validation study required 60 analyses on test samples at the target level 5 microg peanut/g food and 60 analyses at a peanut-free level, which was designed to ensure that the lower 95% confidence limit for the sensitivity and specificity would not be <90%. The probability that a test sample contains an allergen given a prevalence rate of 5% and a positive test result using a single test kit analysis with 95% sensitivity and 95% specificity, which was demonstrated for these test kits, would be 50%. When 2 test kits are run simultaneously on all samples, the probability becomes 95%. It is therefore recommended that all field samples be analyzed with at least 2 of the validated kits.

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.

The Mars Science Laboratory Touchdown Test Facility

NASA Technical Reports Server (NTRS)

White, Christopher; Frankovich, John; Yates, Phillip; Wells Jr, George H.; Losey, Robert

2009-01-01

In the Touchdown Test Program for the Mars Science Laboratory (MSL) mission, a facility was developed to use a full-scale rover vehicle and an overhead winch system to replicate the Skycrane landing event.

Mars Science Laboratory Spacecraft Assembled for Testing

NASA Image and Video Library

2008-11-19

The major components of NASA Mars Science Laboratory spacecraft -- cruise stage atop the aeroshell, which has the descent stage and rover inside -- were connected together in October 2008 for several weeks of system testing.

Easy fix for clinical laboratories for the false-positive defect with the Abbott AxSym total beta-hCG test.

PubMed

Cole, Laurence A; Khanlian, Sarah A

2004-05-01

False-positive hCG results can lead to erroneous diagnoses and needless chemotherapy and surgery. In the last 2 years, eight publications described cases involving false-positive hCG tests; all eight involved the AxSym test. We investigated the source of this abundance of cases and a simple fix that may be used by clinical laboratories. False-positive hCG was primarily identified by absence of hCG in urine and varying or negative hCG results in alternative tests. Seventeen false-positive serum samples in the AxSym test were evaluated undiluted and at twofold dilution with diluent containing excess goat serum or immunoglobulin. We identified 58 patients with false-positive hCG, 47 of 58 due to the Abbott AxSym total hCGbeta test (81%). Sixteen of 17 of these "false-positive" results (mean 100 mIU/ml) became undetectable when tested again after twofold dilution. A simple twofold dilution with this diluent containing excess goat serum or immunoglobulin completely protected 16 of 17 samples from patients having false-positive results. It is recommended that laboratories using this test use twofold dilution as a minimum to prevent false-positive results.

Recommendations on practice of conditioned pain modulation (CPM) testing.

PubMed

Yarnitsky, D; Bouhassira, D; Drewes, A M; Fillingim, R B; Granot, M; Hansson, P; Landau, R; Marchand, S; Matre, D; Nilsen, K B; Stubhaug, A; Treede, R D; Wilder-Smith, O H G

2015-07-01

Protocols for testing conditioned pain modulation (CPM) vary between different labs/clinics. In order to promote research and clinical application of this tool, we summarize the recommendations of interested researchers consensus meeting regarding the practice of CPM and report of its results. © 2014 European Pain Federation - EFIC®

24th geotechnical laboratory testing short course

DOT National Transportation Integrated Search

2008-02-01

This is a 3-day workshop/short course to teach practicing professionals techniques and procedures for conducting high quality geotechnical laboratory tests. Transportation facility design and construction begins with an investigation of the type, ext...

9. Exterior view, Test Cell 7, Systems Integration Laboratory Building ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

9. Exterior view, Test Cell 7, Systems Integration Laboratory Building (T-28), looking southwest. The enclosure discussed in CO-88-B-8 is at the right. - Air Force Plant PJKS, Systems Integration Laboratory, Systems Integration Laboratory Building, Waterton Canyon Road & Colorado Highway 121, Lakewood, Jefferson County, CO

Quality assurance practices in Europe: a survey of molecular genetic testing laboratories

PubMed Central

Berwouts, Sarah; Fanning, Katrina; Morris, Michael A; Barton, David E; Dequeker, Elisabeth

2012-01-01

In the 2000s, a number of initiatives were taken internationally to improve quality in genetic testing services. To contribute to and update the limited literature available related to this topic, we surveyed 910 human molecular genetic testing laboratories, of which 291 (32%) from 29 European countries responded. The majority of laboratories were in the public sector (81%), affiliated with a university hospital (60%). Only a minority of laboratories was accredited (23%), and 26% was certified. A total of 22% of laboratories did not participate in external quality assessment (EQA) and 28% did not use reference materials (RMs). The main motivations given for accreditation were to improve laboratory profile (85%) and national recognition (84%). Nearly all respondents (95%) would prefer working in an accredited laboratory. In accredited laboratories, participation in EQA (P<0.0001), use of RMs (P=0.0014) and availability of continuous education (CE) on medical/scientific subjects (P=0.023), specific tasks (P=0.0018), and quality assurance (P<0.0001) were significantly higher than in non-accredited laboratories. Non-accredited laboratories expect higher restriction of development of new techniques (P=0.023) and improvement of work satisfaction (P=0.0002) than accredited laboratories. By using a quality implementation score (QIS), we showed that accredited laboratories (average score 92) comply better than certified laboratories (average score 69, P<0.001), and certified laboratories better than other laboratories (average score 44, P<0.001), with regard to the implementation of quality indicators. We conclude that quality practices vary widely in European genetic testing laboratories. This leads to a potentially dangerous situation in which the quality of genetic testing is not consistently assured. PMID:22739339

6. Exterior view of Components Test Laboratory (T27), looking southwest. ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

6. Exterior view of Components Test Laboratory (T-27), looking southwest. The building wing on the left houses Test Cell 9 (fuel), and that on the right houses the equipment room. The corrugated aluminum shed that is taller than the main building in the left foreground houses a citric acid air pollution control room (also known as scrubber room), the interior of which may be seen in CO-88-A-21. - Air Force Plant PJKS, Systems Integration Laboratory, Components Test Laboratory, Waterton Canyon Road & Colorado Highway 121, Lakewood, Jefferson County, CO

Hydrogen Field Test Standard: Laboratory and Field Performance

PubMed Central

Pope, Jodie G.; Wright, John D.

2015-01-01

The National Institute of Standards and Technology (NIST) developed a prototype field test standard (FTS) that incorporates three test methods that could be used by state weights and measures inspectors to periodically verify the accuracy of retail hydrogen dispensers, much as gasoline dispensers are tested today. The three field test methods are: 1) gravimetric, 2) Pressure, Volume, Temperature (PVT), and 3) master meter. The FTS was tested in NIST's Transient Flow Facility with helium gas and in the field at a hydrogen dispenser location. All three methods agree within 0.57 % and 1.53 % for all test drafts of helium gas in the laboratory setting and of hydrogen gas in the field, respectively. The time required to perform six test drafts is similar for all three methods, ranging from 6 h for the gravimetric and master meter methods to 8 h for the PVT method. The laboratory tests show that 1) it is critical to wait for thermal equilibrium to achieve density measurements in the FTS that meet the desired uncertainty requirements for the PVT and master meter methods; in general, we found a wait time of 20 minutes introduces errors < 0.1 % and < 0.04 % in the PVT and master meter methods, respectively and 2) buoyancy corrections are important for the lowest uncertainty gravimetric measurements. The field tests show that sensor drift can become a largest component of uncertainty that is not present in the laboratory setting. The scale was calibrated after it was set up at the field location. Checks of the calibration throughout testing showed drift of 0.031 %. Calibration of the master meter and the pressure sensors prior to travel to the field location and upon return showed significant drifts in their calibrations; 0.14 % and up to 1.7 %, respectively. This highlights the need for better sensor selection and/or more robust sensor testing prior to putting into field service. All three test methods are capable of being successfully performed in the field and give

40 CFR 790.20 - Recommendation, recommendation with an intent to designate, and designation of testing candidates...

Code of Federal Regulations, 2014 CFR

2014-07-01

... following manner: (1) When the ITC identifies a chemical substance or mixture that it believes should... of chemicals recommended for testing and include a statement that the ITC intends to designate the substance or mixture for action by EPA in accordance with section 4(e)(1)(B) of TSCA. (2) Chemical...

40 CFR 790.20 - Recommendation, recommendation with an intent to designate, and designation of testing candidates...

Code of Federal Regulations, 2012 CFR

2012-07-01

... following manner: (1) When the ITC identifies a chemical substance or mixture that it believes should... of chemicals recommended for testing and include a statement that the ITC intends to designate the substance or mixture for action by EPA in accordance with section 4(e)(1)(B) of TSCA. (2) Chemical...

40 CFR 790.20 - Recommendation, recommendation with an intent to designate, and designation of testing candidates...

Code of Federal Regulations, 2013 CFR

2013-07-01

... following manner: (1) When the ITC identifies a chemical substance or mixture that it believes should... of chemicals recommended for testing and include a statement that the ITC intends to designate the substance or mixture for action by EPA in accordance with section 4(e)(1)(B) of TSCA. (2) Chemical...

Provider Adherence to Syphilis Testing Recommendations for Women Delivering a Stillbirth.

PubMed

Patel, Chirag G; Huppert, Jill S; Tao, Guoyu

2017-11-01

To assess overall adherence to Centers for Disease Control and Prevention and American College of Obstetrics and Gynecology recommended guidelines for syphilis testing among women who delivered a stillbirth and compare it with other tests recommended for stillbirth evaluation. We used MarketScan claims data with 40 million commercially insured and 8 million Medicaid enrollees annually to estimate prenatal care and follow-up testing among women who had stillbirths between January 1, 2013, and December 24, 2013. Stillbirth was identified if women had any International Classification of Disease, Ninth Revision codes related to a stillbirth outcome. Among women with stillbirths, we estimated the proportions of women who received prenatal care and prenatal syphilis testing within 280 days before stillbirth, and testing at the time of stillbirth (syphilis testing, complete blood count, placental examination and autopsy) using Physician's Current Procedural Terminology codes. We identified 3672 Medicaid-insured women and 6023 commercially insured women with stillbirths in 2013. Approximately, 61.7% of Medicaid-insured women and 66.0% of commercially insured women had claims data indicating prenatal syphilis testing. At the time of stillbirth, Medicaid-insured and commercially insured women had similar rates of syphilis testing (6.5% vs 9.3%), placental examination (61.6% vs 57.8%), and complete blood count (31.9% vs 37.6%). Autopsies were too infrequent to be reported. Approximately, 34.6% of Medicaid-insured women and 29.7% of commercially insured women had no syphilis testing either prenatally or at the time of stillbirth. Syphilis testing among women after stillbirth was less than 10%, illustrating limited adherence to Centers for Disease Control and Prevention and American College of Obstetrics and Gynecology recommendations. Such low prenatal and delivery syphilis testing rates may impact the number of stillbirth cases identified as congenital syphilis cases and

[Proposed recommendations for the practical use of internal quality controls (IQC) in a medical biology laboratory].

PubMed

Giannoli, Jean-Marc; Szymanowicz, Anton

2011-01-01

We propose a set of recommendations and practices to optimize the use of quality control of medical biology examinations. The fundamentals are reviewed: definition of a series of analysis, IQC at one or more level, Westgard alert rules and rejection, practical remedial actions to take for the technician, corrective and preventive actions to be implemented by the biologist. We have also formalized three flowcharts to guide the technician in their daily practice to ensure analytical quality of investigations carried out. These decision trees are the result of the experience submitted by an accredited and professional laboratory attentive to the ongoing improvement of IQC. This article can provide useful assistance to biologists for accreditation but also aims to foster collaboration reliable medical biology laboratory at the appropriate management of patients.

Workgroup for Hydraulic laboratory Testing and Verification of Hydroacoustic Instrumentation

USGS Publications Warehouse

Fulford, Janice M.; Armstrong, Brandy N.; Thibodeaux, Kirk G.

2015-01-01

An international workgroup was recently formed for hydraulic laboratory testing and verification of hydroacoustic instrumentation used for water velocity measurements. The activities of the workgroup have included one face to face meeting, conference calls and an inter-laboratory exchange of two acoustic meters among participating laboratories. Good agreement was found among four laboratories at higher tow speeds and poorer agreement at the lowest tow speed.

Laboratory testing of gross solids removal devices.

DOT National Transportation Integrated Search

2005-05-01

This report details the outcome of tests carried out at the Hydraulics Laboratory : of the University of California, Davis to assess the performance of three : alternative Gross Solids Removal Devices (GSRDs) developed by Caltrans to : remove litter ...

LABORATORY TOXICITY TESTS FOR EVALUATING POTENTIAL EFFECTS OF ENDOCRINE-DISRUPTING COMPOUNDS

EPA Science Inventory

The scope of the Laboratory Testing Work Group was to evaluate methods for testing aquatic and terrestrial invertebrates in the laboratory. Specifically, discussions focused on the following objectives: 1) assess the extent to which consensus-based standard methods and other pub...

Using iron studies to predict HFE mutations in New Zealand: implications for laboratory testing.

PubMed

O'Toole, Rebecca; Romeril, Kenneth; Bromhead, Collette

2017-04-01

The diagnosis of hereditary haemochromatosis (HH) is not straightforward because symptoms are often absent or non-specific. Biochemical markers of iron-overloading may be affected by other conditions. To measure the correlation between iron studies and HFE genotype to inform evidence-based recommendations for laboratory testing in New Zealand. Results from 2388 patients genotyped for C282Y, H63D and S65C in Wellington, New Zealand from 2007 to 2013 were compared with their biochemical phenotype as quantified by serum ferritin (SF), transferrin saturation (TS), serum iron (SI) and serum transferrin (ST). The predictive power of these markers was evaluated by receiver operator characteristic (ROC) curve analysis, and if a statistically significant association for a variable was seen, sensitivity, specificity and predictive values were calculated. Test ordering patterns showed that 62% of HFE genotyping tests were ordered because of an elevated SF alone and only 11% of these had a C-reactive protein test to rule out an acute phase reaction. The association between SF and significant HFE genotypes SF was low. However, TS values ≥45% predicted HH mutations with the highest sensitivity and specificity. A SF of >1000 µg/L was found in one at-risk patient (C282Y homozygote) who had a TS <45%. Our analysis highlights the need for clear guidelines for investigation of hyperferritinaemia and HH in New Zealand. Using our findings, we developed an evidence-based laboratory testing algorithm based on a TS ≥45%, a SF ≥1000 µg/L and/or a family history of HH which identified all C282Y homozygotes in this study. © 2016 Royal Australasian College of Physicians.

Keeping waived tests simple.

PubMed

2004-01-01

Laboratories performing waived testing must follow the manufacturer's instructions as well as good laboratory practices to ensure that test results are reliable. Four things to concentrate on to maximize the performance and reliability of waived tests are to: 1. Read and follow the information found in the package inserts. 2. Follow the manufacturer's recommendations for running quality control. 3. Train staff members to perform tests correctly. 4. Follow established policies and procedures for patient testing in the practice.

2000-hour cyclic endurance test of a laboratory model multipropellant resistojet

NASA Technical Reports Server (NTRS)

Morren, W. Earl; Sovey, James S.

1987-01-01

The technological readiness of a long-life multipropellant resistojet for space station auxiliary propulsion is demonstrated. A laboratory model resistojet made from grain-stabilized platinum served as a test bed to evaluate the design characteristics, fabrication methods, and operating strategies for an engineering model multipropellant resistojet developed under contract by the Rocketdyne Division of Rockwell International and Technion Incorporated. The laboratory model thruster was subjected to a 2000-hr, 2400-thermal-cycle endurance test using carbon dioxide propellant. Maximum thruster temperatures were approximately 1400 C. The post-test analyses of the laboratory model thruster included an investigation of component microstructures. Significant observations from the laboratory model thruster are discussed as they relate to the design of the engineering model thruster.

The testing effect for mediator final test cues and related final test cues in online and laboratory experiments.

PubMed

Coppens, Leonora C; Verkoeijen, Peter P J L; Bouwmeester, Samantha; Rikers, Remy M J P

2016-05-31

The testing effect is the finding that information that is retrieved during learning is more often correctly retrieved on a final test than information that is restudied. According to the semantic mediator hypothesis the testing effect arises because retrieval practice of cue-target pairs (mother-child) activates semantically related mediators (father) more than restudying. Hence, the mediator-target (father-child) association should be stronger for retrieved than restudied pairs. Indeed, Carpenter (2011) found a larger testing effect when participants received mediators (father) than when they received target-related words (birth) as final test cues. The present study started as an attempt to test an alternative account of Carpenter's results. However, it turned into a series of conceptual (Experiment 1) and direct (Experiment 2 and 3) replications conducted with online samples. The results of these online replications were compared with those of similar existing laboratory experiments through small-scale meta-analyses. The results showed that (1) the magnitude of the raw mediator testing effect advantage is comparable for online and laboratory experiments, (2) in both online and laboratory experiments the magnitude of the raw mediator testing effect advantage is smaller than in Carpenter's original experiment, and (3) the testing effect for related cues varies considerably between online experiments. The variability in the testing effect for related cues in online experiments could point toward moderators of the related cue short-term testing effect. The raw mediator testing effect advantage is smaller than in Carpenter's original experiment.

Advanced Materials Laboratory User Test Planning Guide

NASA Technical Reports Server (NTRS)

Orndoff, Evelyne

2012-01-01

Test process, milestones and inputs are unknowns to first-time users of the Advanced Materials Laboratory. The User Test Planning Guide aids in establishing expectations for both NASA and non-NASA facility customers. The potential audience for this guide includes both internal and commercial spaceflight hardware/software developers. It is intended to assist their test engineering personnel in test planning and execution. Material covered includes a roadmap of the test process, roles and responsibilities of facility and user, major milestones, facility capabilities, and inputs required by the facility. Samples of deliverables, test article interfaces, and inputs necessary to define test scope, cost, and schedule are included as an appendix to the guide.

19 CFR 151.54 - Testing by Customs laboratory.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 19 Customs Duties 2 2014-04-01 2014-04-01 false Testing by Customs laboratory. 151.54 Section 151.54 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF HOMELAND SECURITY; DEPARTMENT OF THE TREASURY (CONTINUED) EXAMINATION, SAMPLING, AND TESTING OF MERCHANDISE Metal-Bearing Ores and...

19 CFR 151.54 - Testing by Customs laboratory.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 19 Customs Duties 2 2011-04-01 2011-04-01 false Testing by Customs laboratory. 151.54 Section 151.54 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF HOMELAND SECURITY; DEPARTMENT OF THE TREASURY (CONTINUED) EXAMINATION, SAMPLING, AND TESTING OF MERCHANDISE Metal-Bearing Ores and...

19 CFR 151.54 - Testing by Customs laboratory.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 19 Customs Duties 2 2013-04-01 2013-04-01 false Testing by Customs laboratory. 151.54 Section 151.54 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF HOMELAND SECURITY; DEPARTMENT OF THE TREASURY (CONTINUED) EXAMINATION, SAMPLING, AND TESTING OF MERCHANDISE Metal-Bearing Ores and...

Capability of the Gas Analysis and Testing Laboratory at the NASA Johnson Space Center

NASA Technical Reports Server (NTRS)

Broerman, Craig; Jimenez, Javier; Sweterlitsch, Jeff

2012-01-01

The Gas Analysis and Testing Laboratory is an integral part of the testing performed at the NASA Johnson Space Center. The Gas Analysis and Testing Laboratory is a high performance laboratory providing real time analytical instruments to support manned and unmanned testing. The lab utilizes precision gas chromatographs, gas analyzers and spectrophotometers to support the technology development programs within the NASA community. The Gas Analysis and Testing Laboratory works with a wide variety of customers and provides engineering support for user-specified applications in compressed gas, chemical analysis, general and research laboratory.

Capability of the Gas Analysis and Testing Laboratory at the NASA Johnson Space Center

NASA Technical Reports Server (NTRS)

Broerman, Craig; Jimenez, Javier; Sweterlitsch, Jeff

2011-01-01

The Gas Analysis and Testing Laboratory is an integral part of the testing performed at the NASA Johnson Space Center. The Gas Analysis and Testing Laboratory is a high performance laboratory providing real time analytical instruments to support manned and unmanned testing. The lab utilizes precision gas chromatographs, gas analyzers and spectrophotometers to support the technology development programs within the NASA community. The Gas Analysis and Testing Laboratory works with a wide variety of customers and provides engineering support for user-specified applications in compressed gas, chemical analysis, general and research laboratory

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.

Could accreditation bodies facilitate the implementation of medical guidelines in laboratories?

PubMed

Aakre, Kristin M; Oosterhuis, Wytze P; Misra, Shivani; Langlois, Michel R; Joseph, Watine; Twomey, Patrick J; Barth, Julian H

2017-05-01

Several studies have shown that recommendations related to how laboratory testing should be performed and results interpreted are limited in medical guidelines and that the uptake and implementation of the recommendations that are available need improvement. The EFLM/UEMS Working Group on Guidelines conducted a survey amongst the national societies for clinical chemistry in Europe regarding development of laboratory-related guidelines. The results showed that most countries have guidelines that are specifically related to laboratory testing; however, not all countries have a formal procedure for accepting such guidelines and few countries have guideline committees. Based on this, the EFLM/UEMS Working Group on Guidelines conclude that there is still room for improvement regarding these processes in Europe and raise the question if the accreditation bodies could be a facilitator for an improvement.

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

Overuse of preoperative laboratory coagulation testing and ABO blood typing: a French national study.

PubMed

Beloeil, H; Ruchard, D; Drewniak, N; Molliex, S

2017-12-01

Following publication of guidelines on routine preoperative tests, the French Society of Anaesthesiology and Intensive Care (SFAR), in association with French national public health insurance, conducted a survey to evaluate adherence to guidelines and the economic consequences. Using the French Hospital Discharge Database and National Health Insurance Information system, tests performed during the 30 days before surgery were analysed for two situations: (1) standard laboratory coagulation tests and ABO blood typing in children able to walk and scheduled for tonsillectomy/adenoidectomy; and (2) ABO blood typing in adults before laparoscopic cholecystectomy, thyroidectomy, lumbar discectomy or breast surgery. Guidelines do not recommend any preoperative tests in these settings. Between 2013 and 2015, a coagulation test was performed in 49% of the 241 017 children who underwent tonsillectomy and 39% of the 133 790 children who underwent adenoidectomy. A similar pattern was observed for ABO blood typing although re-operation rates for bleeding on the first postoperative day were very low (0.12-0.31% for tonsillectomy and 0.01-0.02% for adenoidectomy). Between 2012 and 2015, ABO blood typing was performed in 32-45% of the 1 114 082 patients who underwent one of the four selected procedures. The transfusion rate was very low (0.02-0.31%). The mean cost for the four procedures over the 4 yr period was €5 310 000 (sd €325 000). Standard laboratory coagulation tests and ABO blood typing are still routinely prescribed before surgery and anaesthesia despite current guidelines. This over-prescription represents a high and unnecessary cost, and should therefore be addressed. © The Author 2017. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Laboratory errors and patient safety.

PubMed

Miligy, Dawlat A

2015-01-01

Laboratory data are extensively used in medical practice; consequently, laboratory errors have a tremendous impact on patient safety. Therefore, programs designed to identify and reduce laboratory errors, as well as, setting specific strategies are required to minimize these errors and improve patient safety. The purpose of this paper is to identify part of the commonly encountered laboratory errors throughout our practice in laboratory work, their hazards on patient health care and some measures and recommendations to minimize or to eliminate these errors. Recording the encountered laboratory errors during May 2008 and their statistical evaluation (using simple percent distribution) have been done in the department of laboratory of one of the private hospitals in Egypt. Errors have been classified according to the laboratory phases and according to their implication on patient health. Data obtained out of 1,600 testing procedure revealed that the total number of encountered errors is 14 tests (0.87 percent of total testing procedures). Most of the encountered errors lay in the pre- and post-analytic phases of testing cycle (representing 35.7 and 50 percent, respectively, of total errors). While the number of test errors encountered in the analytic phase represented only 14.3 percent of total errors. About 85.7 percent of total errors were of non-significant implication on patients health being detected before test reports have been submitted to the patients. On the other hand, the number of test errors that have been already submitted to patients and reach the physician represented 14.3 percent of total errors. Only 7.1 percent of the errors could have an impact on patient diagnosis. The findings of this study were concomitant with those published from the USA and other countries. This proves that laboratory problems are universal and need general standardization and bench marking measures. Original being the first data published from Arabic countries that

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.

42 CFR 410.32 - Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Procedural Terminology published by the American Medical Association. (vii) Diagnostic tests performed by a... & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICARE PROGRAM SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS Medical and Other Health Services § 410.32 Diagnostic x-ray tests, diagnostic laboratory...

42 CFR 410.32 - Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Procedural Terminology published by the American Medical Association. (vii) Diagnostic tests performed by a... & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICARE PROGRAM SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS Medical and Other Health Services § 410.32 Diagnostic x-ray tests, diagnostic laboratory...

Access to laboratory testing: the impact of managed care in the Pacific Northwest.

PubMed

LaBeau, K M; Simon, M; Steindel, S J

1999-01-01

Patient access to health-care services has become an important issue owing to the growth of managed care organizations and the number of patients enrolled. To better understand the current issues related to access to laboratory testing, with a particular focus on the impact of managed care, we gathered information from a network of clinical laboratories in the Pacific Northwest. Two questionnaires were sent to the 257 Laboratory Medicine Sentinel Monitoring Network participants in November 1995 and March 1996 to investigate trends in the availability and utilization of laboratory testing services and changes in onsite testing menus. Although laboratories reported that managed care was a factor in their decisions about laboratory practices, testing decisions were more likely made for business reasons, based on medical practice changes and marketplace influences not associated with managed care.

In-flight and laboratory vacuum-friction test results

NASA Technical Reports Server (NTRS)

Devine, E. J.; Evans, H. E.; Leasure, W. A.

1973-01-01

Coefficient of friction measurements were made for six unlubricated metal couples exposed to the space environment aboard the OV-1-13 spacecraft and exposed to laboratory vacuum. Materials studied included mutually soluble, partially soluble, and insoluble metal combinations. Two samples of each material couple were tested in space and in the laboratory using the disk and rider technique. Linear velocity was 0.10 cm/s (2.5 in/min) and rider normal load was 4.45 N (1 lb) for the gold versus silver couples and 8.90 N (2lb) for the other combinations. Results showed that friction data obtained in a clean ion-pumped laboratory vacuum of 10 to the minus 10 power materials with low mutual solubility can be correlated to operation in the vicinity of a typical scientific spacecraft that is exposed to an ambient pressure as low as 10 to the minus 12 power torr. The expected increase in coefficient of friction with solubility was shown. Material couples with high mutual solubility present the hazard of unpredictable drastic friction increase in orbit which may not be evident in laboratory testing at levels down to 10 to the minus 10 power torr. It was also shown that gross cold welding of unlubricated metals exposed to a satellite environment does not occur.

Duplicate laboratory test reduction using a clinical decision support tool.

PubMed

Procop, Gary W; Yerian, Lisa M; Wyllie, Robert; Harrison, A Marc; Kottke-Marchant, Kandice

2014-05-01

Duplicate laboratory tests that are unwarranted increase unnecessary phlebotomy, which contributes to iatrogenic anemia, decreased patient satisfaction, and increased health care costs. We employed a clinical decision support tool (CDST) to block unnecessary duplicate test orders during the computerized physician order entry (CPOE) process. We assessed laboratory cost savings after 2 years and searched for untoward patient events associated with this intervention. This CDST blocked 11,790 unnecessary duplicate test orders in these 2 years, which resulted in a cost savings of $183,586. There were no untoward effects reported associated with this intervention. The movement to CPOE affords real-time interaction between the laboratory and the physician through CDSTs that signal duplicate orders. These interactions save health care dollars and should also increase patient satisfaction and well-being.

Mars Science Laboratory Rover System Thermal Test

NASA Technical Reports Server (NTRS)

Novak, Keith S.; Kempenaar, Joshua E.; Liu, Yuanming; Bhandari, Pradeep; Dudik, Brenda A.

2012-01-01

On November 26, 2011, NASA launched a large (900 kg) rover as part of the Mars Science Laboratory (MSL) mission to Mars. The MSL rover is scheduled to land on Mars on August 5, 2012. Prior to launch, the Rover was successfully operated in simulated mission extreme environments during a 16-day long Rover System Thermal Test (STT). This paper describes the MSL Rover STT, test planning, test execution, test results, thermal model correlation and flight predictions. The rover was tested in the JPL 25-Foot Diameter Space Simulator Facility at the Jet Propulsion Laboratory (JPL). The Rover operated in simulated Cruise (vacuum) and Mars Surface environments (8 Torr nitrogen gas) with mission extreme hot and cold boundary conditions. A Xenon lamp solar simulator was used to impose simulated solar loads on the rover during a bounding hot case and during a simulated Mars diurnal test case. All thermal hardware was exercised and performed nominally. The Rover Heat Rejection System, a liquid-phase fluid loop used to transport heat in and out of the electronics boxes inside the rover chassis, performed better than predicted. Steady state and transient data were collected to allow correlation of analytical thermal models. These thermal models were subsequently used to predict rover thermal performance for the MSL Gale Crater landing site. Models predict that critical hardware temperatures will be maintained within allowable flight limits over the entire 669 Sol surface mission.

Comparison of the performance of laboratory tests in the diagnosis of feline infectious peritonitis.

PubMed

Stranieri, Angelica; Giordano, Alessia; Paltrinieri, Saverio; Giudice, Chiara; Cannito, Valentina; Lauzi, Stefania

2018-05-01

We compared the performance of clinicopathologic and molecular tests used in the antemortem diagnosis of feline infectious peritonitis (FIP). From 16 FIP and 14 non-FIP cats, we evaluated retrospectively the sensitivity, specificity, and likelihood ratios (LRs) of serum protein electrophoresis, α 1 -acid glycoprotein (AGP) on peripheral blood, screening reverse-transcription nested PCR (RT-nPCR) on the 3'-untranslated region (3'-UTR), and spike (S) gene sequencing on peripheral blood, body cavity effusions, and tissue, as well as body cavity cytology and delta total nucleated cell count (ΔTNC). Any of these tests on blood, and especially the molecular tests, may support or confirm a clinical diagnosis of FIP. A negative result does not exclude the disease except for AGP. Cytology, 3'-UTR PCR, and ΔTNC may confirm a clinical diagnosis on effusions; cytology or 3'-UTR PCR may exclude FIP. Conversely, S gene sequencing is not recommended based on the LRs. On tissues, S gene sequencing is preferable when histology is highly consistent with FIP, and 3'-UTR PCR when FIP is unlikely. Combining one test with high LR+ with one with low LR- (e.g., molecular tests and AGP on blood, ΔTNC and cytology in effusions) may improve the diagnostic power of the most used laboratory tests.

Trends in Testing for Mycobacterium tuberculosis Complex From US Public Health Laboratories, 2009-2013.

PubMed

Tyrrell, Frances; Stafford, Cortney; Yakrus, Mitchell; Youngblood, Monica; Hill, Andrew; Johnston, Stephanie

We investigated data from US public health laboratories funded through the Centers for Disease Control and Prevention's Tuberculosis Elimination and Laboratory Cooperative Agreement to document trends and challenges in meeting national objectives in tuberculosis (TB) laboratory diagnoses. We examined data on workload and turnaround time from public health laboratories' progress reports during 2009-2013. We reviewed methodologies, laboratory roles, and progress toward rapid detection of Mycobacterium tuberculosis complex through nucleic acid amplification (NAA) testing. We compared selected data with TB surveillance reports to estimate public health laboratories' contribution to national diagnostic services. During the study period, culture and drug susceptibility tests decreased, but NAA testing increased. Public health laboratories achieved turnaround time benchmarks for drug susceptibility tests at lower levels than for acid-fast bacilli smear and identification from culture. NAA positivity in laboratories among surveillance-reported culture-positive TB cases increased from 26.6% (2355 of 8876) in 2009 to 40.0% (2948 of 7358) in 2013. Public health laboratories provided an estimated 50.9% (4285 of 8413 in 2010) to 57.2% (4210 of 7358 in 2013) of culture testing and 88.3% (6822 of 7727 in 2011) to 94.4% (6845 of 7250 in 2012) of drug susceptibility tests for all US TB cases. Public health laboratories contribute substantially to TB diagnoses in the United States. Although testing volumes mostly decreased, the increase in NAA testing indicates continued progress in rapid M tuberculosis complex detection.

Laboratory test for ice adhesion strength using commercial instrumentation.

PubMed

Wang, Chenyu; Zhang, Wei; Siva, Adarsh; Tiea, Daniel; Wynne, Kenneth J

2014-01-21

A laboratory test method for evaluating ice adhesion has been developed employing a commercially available instrument normally used for dynamic mechanical analysis (TA RSA-III). This is the first laboratory ice adhesion test that does not require a custom-built apparatus. The upper grip range of ∼10 mm is an enabling feature that is essential for the test. The method involves removal of an ice cylinder from a polymer coating with a probe and the determination of peak removal force (Ps). To validate the test method, the strength of ice adhesion was determined for a prototypical glassy polymer, poly(methyl methacrylate). The distance of the probe from the PMMA surface has been identified as a critical variable for Ps. The new test provides a readily available platform for investigating fundamental surface characteristics affecting ice adhesion. In addition to the ice release test, PMMA coatings were characterized using DSC, DCA, and TM-AFM.

Pilot instrumentation of a Superpave test section at the Kansas Accelerated Testing laboratory

DOT National Transportation Integrated Search

2003-04-01

Two Superpave test sections were constructed at the Kansas Accelerated Testing Laboratory (K-ATL) with 12.5 mm (2 in) nominal maximum size Superpave mixture (SM-2A) with varying percentages (15 and 30 percent) of river sand. A 150 kN (34 kip) tandem ...

78 FR 53773 - Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-30

...] Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and... Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems.'' FDA has developed this guidance to inform the coronary and peripheral stent industry about selected updates to FDA's...

77 FR 31620 - Medicare Program; Public Meeting in Calendar Year 2012 for New Clinical Laboratory Tests Payment...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-29

... announces a public meeting to receive comments and recommendations from the public on the appropriate basis... System (HCPCS) codes being considered for Medicare payment under the clinical laboratory fee schedule... the Federal Register notice of a meeting to receive comments and recommendations (and data on which...

Performance testing of radiobioassay laboratories: In vivo measurements, Final Report

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

MacLellan, J.A.; Traub, R.J.; Olsen, P.C.

1990-04-01

A study of two rounds of in vivo laboratory performance testing was undertaken by Pacific Northwest Laboratory (PNL) to determine the appropriateness of the in vivo performance criteria of draft American National Standards Institute (ANSI) standard ANSI N13.3, Performance Criteria for Bioassay.'' The draft standard provides guidance to in vivo counting facilities regarding the sensitivity, precision, and accuracy of measurements for certain categories of commonly assayed radionuclides and critical regions of the body. This report concludes the testing program by presenting the results of the Round Two testing. Testing involved two types of measurements: chest counting for radionuclide detection inmore » the lung, and whole body counting for detection of uniformly distributed material. Each type of measurement was further divided into radionuclide categories as defined in the draft standard. The appropriateness of the draft standard criteria by measuring a laboratory's ability to attain them were judged by the results of both round One and Round Two testing. The testing determined that performance criteria are set at attainable levels, and the majority of in vivo monitoring facilities passed the criteria when complete results were submitted. 18 refs., 18 figs., 15 tabs.« less

Analysis and Test Support for Phillips Laboratory Precision Structures

DTIC Science & Technology

1998-11-01

Air Force Research Laboratory ( AFRL ), Phillips Research Site . Task objectives centered...around analysis and structural dynamic test support on experiments within the Space Vehicles Directorate at Kirtland Air Force Base. These efforts help...support for Phillips Laboratory Precision Structures." Mr. James Goodding of CSA Engineering was the principal investigator for this task. Mr.

Ligand binding assays in the 21st century laboratory: recommendations for characterization and supply of critical reagents.

PubMed

O'Hara, Denise M; Theobald, Valerie; Egan, Adrienne Clements; Usansky, Joel; Krishna, Murli; TerWee, Julie; Maia, Mauricio; Spriggs, Frank P; Kenney, John; Safavi, Afshin; Keefe, Jeannine

2012-06-01

Critical reagents are essential components of ligand binding assays (LBAs) and are utilized throughout the process of drug discovery, development, and post-marketing monitoring. Successful lifecycle management of LBA critical reagents minimizes assay performance problems caused by declining reagent activity and can mitigate the risk of delays during preclinical and clinical studies. Proactive reagent management assures adequate supply. It also assures that the quality of critical reagents is appropriate and consistent for the intended LBA use throughout all stages of the drug development process. This manuscript summarizes the key considerations for the generation, production, characterization, qualification, documentation, and management of critical reagents in LBAs, with recommendations for antibodies (monoclonal and polyclonal), engineered proteins, peptides, and their conjugates. Recommendations are given for each reagent type on basic and optional characterization profiles, expiration dates and storage temperatures, and investment in a knowledge database system. These recommendations represent a consensus among the authors and should be used to assist bioanalytical laboratories in the implementation of a best practices program for critical reagent life cycle management.

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.

Effects of vigorous mixing of blood vacuum tubes on laboratory test results.

PubMed

Lima-Oliveira, Gabriel; Lippi, Giuseppe; Salvagno, Gian Luca; Montagnana, Martina; Gelati, Matteo; Volanski, Waldemar; Boritiza, Katia Cristina; Picheth, Geraldo; Guidi, Gian Cesare

2013-02-01

To evaluate the effect of tubes mixing (gentle vs. vigorous) on diagnostic blood specimens collected in vacuum tube systems by venipuncture. Blood was collected for routine coagulation, immunochemistry and hematological testing from one hundred volunteers into six vacuum tubes: two 3.6 mL vacuum tubes containing 0.4 mL of buffered sodium citrate (9NC) 0.109 mol/L: 3.2 W/V%; two 3.5 mL vacuum tubes with clot activator and gel separator; and two 3.0 mL vacuum tubes containing 5.9 mg K(2)EDTA (Terumo Europe, Belgium). Immediately after the venipuncture all vacuum tubes (each of one additive type) were processed through two different procedures: i) Standard: blood specimens in K(2)EDTA- or sodium citrate-vacuum tubes were gently inverted five times whereas the specimens in tubes with clot activator and gel separator were gently inverted ten times, as recommended by the manufacturer; ii) Vigorous mix: all blood specimens were shaken up vigorously during 3-5s independently of the additive type inside the tubes. The significance of the differences between samples was assessed by Student's t-test or Wilcoxon ranked-pairs test after checking for normality. The level of statistical significance was set at P<0.05. No significant difference (P<0.05) was detected between the procedures for all tested parameters. Surprisingly only a visual alteration (presence of foam on the top) was shown by all the tubes mixed vigorously before centrifugation (Fig. 1 A, B and C). Moreover the serum tubes from vigorous mixing procedure shows a "blood ring" on the tube top after stopper removal (Fig. 1 D). Our results drop out a paradigm suggesting that the incorrect primary blood tubes mixing promotes laboratory variability. We suggest that similar evaluation should be done using other brands of vacuum tubes by each laboratory manager. Copyright © 2012 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Text Messaging Improves Participation in Laboratory Testing in Adolescent Liver Transplant Patients.

PubMed

McKenzie, Rebecca B; Berquist, William E; Foley, Megan A; Park, K T; Windsheimer, Jered E; Litt, Iris F

In solid organ transplant patients, non-participation in all aspects of the medical regimen is a prevalent problem associated with adverse consequences particularly in the adolescent and young adult (AYA) age group. This study is the first to evaluate the feasibility, utility and impact of a text messaging (TM) intervention to improve participation in laboratory testing in adolescent liver transplant patients. AYA patients, aged 12 to 21 years, were recruited for a prospective pilot trial evaluating a TM intervention delivered over a 1-year period. The intervention involved automated TM reminders with feedback administered according to a prescribed laboratory testing frequency. Participation rate in laboratory testing after the intervention was compared to the year prior. Patient responses and feedback by text and survey were used to assess feasibility, acceptability and use of the intervention. Forty-two patients were recruited and 33 patients remained enrolled for the study duration. Recipients of the TM intervention demonstrated a significant improvement in participation rate in laboratory testing from 58% to 78% (P<.001). This rate was also significantly higher than in non-intervention controls (P=.003). There was a high acceptability, response rate and a significant correlation with reported versus actual completion of laboratory tests by TM. TM reminders significantly improved participation in laboratory testing in AYA liver transplant patients. The intervention demonstrated feasibility, acceptability, and use with a high proportion of patients who engaged in and perceived a benefit from using this technology.

Laboratory testing in primary care: A systematic review of health IT impacts.

PubMed

Maillet, Éric; Paré, Guy; Currie, Leanne M; Raymond, Louis; Ortiz de Guinea, Ana; Trudel, Marie-Claude; Marsan, Josianne

2018-08-01

Laboratory testing in primary care is a fundamental process that supports patient management and care. Any breakdown in the process may alter clinical information gathering and decision-making activities and can lead to medical errors and potential adverse outcomes for patients. Various information technologies are being used in primary care with the goal to support the process, maximize patient benefits and reduce medical errors. However, the overall impact of health information technologies on laboratory testing processes has not been evaluated. To synthesize the positive and negative impacts resulting from the use of health information technology in each phase of the laboratory 'total testing process' in primary care. We conducted a systematic review. Databases including Medline, PubMed, CINAHL, Web of Science and Google Scholar were searched. Studies eligible for inclusion reported empirical data on: 1) the use of a specific IT system, 2) the impacts of the systems to support the laboratory testing process, and were conducted in 3) primary care settings (including ambulatory care and primary care offices). Our final sample consisted of 22 empirical studies which were mapped to a framework that outlines the phases of the laboratory total testing process, focusing on phases where medical errors may occur. Health information technology systems support several phases of the laboratory testing process, from ordering the test to following-up with patients. This is a growing field of research with most studies focusing on the use of information technology during the final phases of the laboratory total testing process. The findings were largely positive. Positive impacts included easier access to test results by primary care providers, reduced turnaround times, and increased prescribed tests based on best practice guidelines. Negative impacts were reported in several studies: paper-based processes employed in parallel to the electronic process increased the potential

Remotely accessible laboratory for MEMS testing

NASA Astrophysics Data System (ADS)

Sivakumar, Ganapathy; Mulsow, Matthew; Melinger, Aaron; Lacouture, Shelby; Dallas, Tim E.

2010-02-01

We report on the construction of a remotely accessible and interactive laboratory for testing microdevices (aka: MicroElectroMechancial Systems - MEMS). Enabling expanded utilization of microdevices for research, commercial, and educational purposes is very important for driving the creation of future MEMS devices and applications. Unfortunately, the relatively high costs associated with MEMS devices and testing infrastructure makes widespread access to the world of MEMS difficult. The creation of a virtual lab to control and actuate MEMS devices over the internet helps spread knowledge to a larger audience. A host laboratory has been established that contains a digital microscope, microdevices, controllers, and computers that can be logged into through the internet. The overall layout of the tele-operated MEMS laboratory system can be divided into two major parts: the server side and the client side. The server-side is present at Texas Tech University, and hosts a server machine that runs the Linux operating system and is used for interfacing the MEMS lab with the outside world via internet. The controls from the clients are transferred to the lab side through the server interface. The server interacts with the electronics required to drive the MEMS devices using a range of National Instruments hardware and LabView Virtual Instruments. An optical microscope (100 ×) with a CCD video camera is used to capture images of the operating MEMS. The server broadcasts the live video stream over the internet to the clients through the website. When the button is pressed on the website, the MEMS device responds and the video stream shows the movement in close to real time.

40 CFR Appendix II to Part 1054 - Duty Cycles for Laboratory Testing

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 32 2010-07-01 2010-07-01 false Duty Cycles for Laboratory Testing II.... 1054, App. II Appendix II to Part 1054—Duty Cycles for Laboratory Testing (a) Test handheld engines with the following steady-state duty cycle: G3 mode No. Engine speed a Torque(percent) b Weighting...

42 CFR 493.20 - Laboratories performing tests of moderate complexity.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Laboratories performing tests of moderate complexity. 493.20 Section 493.20 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS General...

42 CFR 493.20 - Laboratories performing tests of moderate complexity.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Laboratories performing tests of moderate complexity. 493.20 Section 493.20 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS General...

Federal Security Laboratory Governance Panels: Observations and Recommendations

DTIC Science & Technology

2013-01-01

operates under a sole-source, cost-plus-fixed-fee contract administered by the U.S. Navy’s Naval Sea Systems Command. There are currently 14 UARCs, 13... system of research organizations that support science and technology for U.S. national security. Within this system , the Departments of Defense, Energy...and Homeland Security support about 80 laboratories that focus predominantly on national security matters. These laboratories have different

The laboratory test utilization management toolbox

PubMed Central

Baird, Geoffrey

2014-01-01

Efficiently managing laboratory test utilization requires both ensuring adequate utilization of needed tests in some patients and discouraging superfluous tests in other patients. After the difficult clinical decision is made to define the patients that do and do not need a test, a wealth of interventions are available to the clinician and laboratorian to help guide appropriate utilization. These interventions are collectively referred to here as the utilization management toolbox. Experience has shown that some tools in the toolbox are weak and other are strong, and that tools are most effective when many are used simultaneously. While the outcomes of utilization management studies are not always as concrete as may be desired, what data is available in the literature indicate that strong utilization management interventions are safe and effective measures to improve patient health and reduce waste in an era of increasing financial pressure. PMID:24969916

Test Guideline Methods for Bed Bug Pesticide Products Now Available

EPA Pesticide Factsheets

EPA’s final test guidelines, 810.3900 - Laboratory Product Performance Testing Methods for Bed Bug Pesticide Products, provides recommendations for the design and execution of laboratory studies to evaluate the performance of pesticide products.

A 2000-hour cyclic endurance test of a laboratory model multipropellant resistojet

NASA Technical Reports Server (NTRS)

Morren, W. Earl; Sovey, James S.

1987-01-01

The technological readiness of a long-life multipropellant resistojet for space station auxiliary propulsion is demonstrated. A laboratory model resistojet made from grain-stabilized platinum served as a test bed to evaluate the design characteristics, fabrication methods, and operating strategies for an engineering model multipropellant resistojet developed under contract by the Rocketdyne Division of Rockwell International and Technion Incorporated. The laboratory model thruster was subjected to a 2000-hr, 2400-thermal-cycle endurance test using carbon dioxide propellant. Maximum thruster temperatures were approximately 1400 C. The post-test analyses of the laboratory model thruster included an investigation of component microstructures. Significant observations from the laboratory model thruster are discussed as they relate to the design of the engineering model thruster.

Effectiveness of a computerized alert system based on re-testing intervals for limiting the inappropriateness of laboratory test requests.

PubMed

Lippi, Giuseppe; Brambilla, Marco; Bonelli, Patrizia; Aloe, Rosalia; Balestrino, Antonio; Nardelli, Anna; Ceda, Gian Paolo; Fabi, Massimo

2015-11-01

There is consolidated evidence that the burden of inappropriate laboratory test requests is very high, up to 70%. We describe here the function of a computerized alert system linked to the order entry, designed to limit the number of potentially inappropriate laboratory test requests. A computerized alert system based on re-testing intervals and entailing the generation of pop-up alerts when preset criteria of appropriateness for 15 laboratory tests were violated was implemented in two clinical wards of the University Hospital of Parma. The effectiveness of the system for limiting potentially inappropriate tests was monitored for 6months. Overall, 765/3539 (22%) test requests violated the preset criteria of appropriateness and generated the appearance of electronic alert. After alert appearance, 591 requests were annulled (17% of total tests requested and 77% of tests alerted, respectively). The total number of test requests violating the preset criteria of inappropriateness constantly decreased over time (26% in the first three months of implementation versus 17% in the following period; p<0.001). The total financial saving of test withdrawn was 3387 Euros (12.8% of the total test cost) throughout the study period. The results of this study suggest that a computerized alert system may be effective to limit the inappropriateness of laboratory test requests, generating significant economic saving and educating physicians to a more efficient use of laboratory resources. Copyright © 2015 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

LabRS: A Rosetta stone for retrospective standardization of clinical laboratory test results.

PubMed

Hauser, Ronald George; Quine, Douglas B; Ryder, Alex

2018-02-01

Clinical laboratories in the United States do not have an explicit result standard to report the 7 billion laboratory tests results they produce each year. The absence of standardized test results creates inefficiencies and ambiguities for secondary data users. We developed and tested a tool to standardize the results of laboratory tests in a large, multicenter clinical data warehouse. Laboratory records, each of which consisted of a laboratory result and a test identifier, from 27 diverse facilities were captured from 2000 through 2015. Each record underwent a standardization process to convert the original result into a format amenable to secondary data analysis. The standardization process included the correction of typos, normalization of categorical results, separation of inequalities from numbers, and conversion of numbers represented by words (eg, "million") to numerals. Quality control included expert review. We obtained 1.266 × 109 laboratory records and standardized 1.252 × 109 records (98.9%). Of the unique unstandardized records (78.887 × 103), most appeared <5 times (96%, eg, typos), did not have a test identifier (47%), or belonged to an esoteric test with <100 results (2%). Overall, these 3 reasons accounted for nearly all unstandardized results (98%). Current results suggest that the tool is both scalable and generalizable among diverse clinical laboratories. Based on observed trends, the tool will require ongoing maintenance to stay current with new tests and result formats. Future work to develop and implement an explicit standard for test results would reduce the need to retrospectively standardize test results. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

System reliability of randomly vibrating structures: Computational modeling and laboratory testing

NASA Astrophysics Data System (ADS)

Sundar, V. S.; Ammanagi, S.; Manohar, C. S.

2015-09-01

The problem of determination of system reliability of randomly vibrating structures arises in many application areas of engineering. We discuss in this paper approaches based on Monte Carlo simulations and laboratory testing to tackle problems of time variant system reliability estimation. The strategy we adopt is based on the application of Girsanov's transformation to the governing stochastic differential equations which enables estimation of probability of failure with significantly reduced number of samples than what is needed in a direct simulation study. Notably, we show that the ideas from Girsanov's transformation based Monte Carlo simulations can be extended to conduct laboratory testing to assess system reliability of engineering structures with reduced number of samples and hence with reduced testing times. Illustrative examples include computational studies on a 10-degree of freedom nonlinear system model and laboratory/computational investigations on road load response of an automotive system tested on a four-post test rig.

College of American Pathologists' laboratory standards for next-generation sequencing clinical tests.

PubMed

Aziz, Nazneen; Zhao, Qin; Bry, Lynn; Driscoll, Denise K; Funke, Birgit; Gibson, Jane S; Grody, Wayne W; Hegde, Madhuri R; Hoeltge, Gerald A; Leonard, Debra G B; Merker, Jason D; Nagarajan, Rakesh; Palicki, Linda A; Robetorye, Ryan S; Schrijver, Iris; Weck, Karen E; Voelkerding, Karl V

2015-04-01

The higher throughput and lower per-base cost of next-generation sequencing (NGS) as compared to Sanger sequencing has led to its rapid adoption in clinical testing. The number of laboratories offering NGS-based tests has also grown considerably in the past few years, despite the fact that specific Clinical Laboratory Improvement Amendments of 1988/College of American Pathologists (CAP) laboratory standards had not yet been developed to regulate this technology. To develop a checklist for clinical testing using NGS technology that sets standards for the analytic wet bench process and for bioinformatics or "dry bench" analyses. As NGS-based clinical tests are new to diagnostic testing and are of much greater complexity than traditional Sanger sequencing-based tests, there is an urgent need to develop new regulatory standards for laboratories offering these tests. To develop the necessary regulatory framework for NGS and to facilitate appropriate adoption of this technology for clinical testing, CAP formed a committee in 2011, the NGS Work Group, to deliberate upon the contents to be included in the checklist. Results . -A total of 18 laboratory accreditation checklist requirements for the analytic wet bench process and bioinformatics analysis processes have been included within CAP's molecular pathology checklist (MOL). This report describes the important issues considered by the CAP committee during the development of the new checklist requirements, which address documentation, validation, quality assurance, confirmatory testing, exception logs, monitoring of upgrades, variant interpretation and reporting, incidental findings, data storage, version traceability, and data transfer confidentiality.

Laboratory Tests

MedlinePlus

... PI CONNECT Research Network USIDNET Patient Registry IDF Survey Research IDF Surveys National Health Insurance Surveys Clinical Trials ... and Fellows Research USIDNET IDF Research Fund IDF Survey Research IDF Surveys Contact Us Search form Search Laboratory ...

49 CFR 40.89 - What is validity testing, and are laboratories required to conduct it?

Code of Federal Regulations, 2013 CFR

2013-10-01

... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.89 What is validity testing, and are laboratories required to conduct it? (a) Specimen validity testing is... 49 Transportation 1 2013-10-01 2013-10-01 false What is validity testing, and are laboratories...

49 CFR 40.89 - What is validity testing, and are laboratories required to conduct it?

Code of Federal Regulations, 2011 CFR

2011-10-01

... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.89 What is validity testing, and are laboratories required to conduct it? (a) Specimen validity testing is... 49 Transportation 1 2011-10-01 2011-10-01 false What is validity testing, and are laboratories...

49 CFR 40.89 - What is validity testing, and are laboratories required to conduct it?

Code of Federal Regulations, 2010 CFR

2010-10-01

... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.89 What is validity testing, and are laboratories required to conduct it? (a) Specimen validity testing is... 49 Transportation 1 2010-10-01 2010-10-01 false What is validity testing, and are laboratories...

49 CFR 40.89 - What is validity testing, and are laboratories required to conduct it?

Code of Federal Regulations, 2012 CFR

2012-10-01

... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.89 What is validity testing, and are laboratories required to conduct it? (a) Specimen validity testing is... 49 Transportation 1 2012-10-01 2012-10-01 false What is validity testing, and are laboratories...

49 CFR 40.89 - What is validity testing, and are laboratories required to conduct it?

Code of Federal Regulations, 2014 CFR

2014-10-01

... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.89 What is validity testing, and are laboratories required to conduct it? (a) Specimen validity testing is... 49 Transportation 1 2014-10-01 2014-10-01 false What is validity testing, and are laboratories...

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...

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...

A comparison of relative toxicity rankings by some small-scale laboratory tests

NASA Technical Reports Server (NTRS)

Hilado, C. J.; Cumming, H. J.

1977-01-01

Small-scale laboratory tests for fire toxicity, suitable for use in the average laboratory hood, are needed for screening and ranking materials on the basis of relative toxicity. The performance of wool, cotton, and aromatic polyamide under several test procedures is presented.

Recommendations for elaboration, transcultural adaptation and validation process of tests in Speech, Hearing and Language Pathology.

PubMed

Pernambuco, Leandro; Espelt, Albert; Magalhães, Hipólito Virgílio; Lima, Kenio Costa de

2017-06-08

to present a guide with recommendations for translation, adaptation, elaboration and process of validation of tests in Speech and Language Pathology. the recommendations were based on international guidelines with a focus on the elaboration, translation, cross-cultural adaptation and validation process of tests. the recommendations were grouped into two Charts, one of them with procedures for translation and transcultural adaptation and the other for obtaining evidence of validity, reliability and measures of accuracy of the tests. a guide with norms for the organization and systematization of the process of elaboration, translation, cross-cultural adaptation and validation process of tests in Speech and Language Pathology was created.

Agreement between the 'point of care' tests for microalbuminuria and HbA1c performed in mexican family medicine units and the results of standard laboratory tests.

PubMed

Valdez-González, Leticia A; Méndez-Padrón, Araceli; Gómez-Díaz, Rita A; Valladares-Salgado, Adán; Sánchez-Becerra, Martha Catalina; Mondragón-González, Rafael; Hernández-Rubí, Jaime; González-Hermosillo, Arturo; Cruz, Miguel; Borja, Víctor; Wacher, Niels H

The albumin-creatinine ratio is considered an indicator of microalbuminuria, precursor to chronic kidney disease, while HbA1c is used to measure glycemic control. Given the prevalence of diabetes-related nephropathy, spot testing of albumin has long been recommended as a preventative measure, for the timely detection of microalbuminuria. However, many countries do not have this testing available in primary care, and sometimes not even in second- and third-level care. The objective of this study was to compare agreement of the microalbuminuria and HbA1c results obtained in the laboratory with 'gold standard' techniques, with those obtained on site with a 'Point of Care' DCA Vantage™ device by Siemens. Results for the albumin-creatinine ratio and HbA1c from the Siemens DCA Vantage™ point of care device were compared with those from standard laboratory tests in 25 family medicine units in Mexico City and Toluca, State of Mexico, in patients diagnosed with type-2 diabetes. Agreement between the albumin values of the 2 tests was 0.745 (CI 95% 0.655-0.812). Agreement between the two measurement techniques for HbA1c was 0.970 (CI 95% 0.966-0.973). The results obtained were sufficiently comparative (R i = 0.74 for albumin-creatinine ratio and R i  = 0.97 for HbA1c) to justify the use of the point of care device. Given the high agreement between the point of care device and laboratory tests, this device could be used to identify chronic kidney disease and glycemic control for more adequate treatment in patients with diabetes, especially in remote areas.

Designation, diligence and drift: understanding laboratory expenditure increases in British Columbia, 1996/97 to 2005/06.

PubMed

Sivananthan, Saskia N; Peterson, Sandra; Lavergne, Ruth; Barer, Morris L; McGrail, Kimberlyn M

2012-12-21

Laboratory testing is one of the fastest growing areas of health services spending in Canada. We examine the extent to which increases in laboratory expenditures might be explained by testing that is consistent with guidelines for the management of chronic conditions, by analyzing fee-for-service physician payment data in British Columbia from 1996/97 and 2005/06. We used direct standardization to quantify the effect on laboratory expenditures from changes in: fee levels; population growth; population aging; treatment prevalence; expenditure on recommended tests for those conditions; and expenditure on other tests. The chronic conditions selected were those with guidelines containing laboratory recommendations developed by the BC Guidelines and Protocol Advisory Committee: diabetes, hypertension, congestive heart failure, renal failure, liver disease, rheumatoid arthritis, osteoarthritis and dementia. Laboratory service expenditures increased by $98 million in 2005/06 compared to 1996/97, or 3.6% per year after controlling for population growth and aging. Testing consistent with guideline-recommended care for chronic conditions explained one-third (1.2% per year) of this growth. Changes in treatment prevalence were just as important, contributing 1.5% per year. Hypertension was the most common condition, but renal failure and dementia showed the largest changes in prevalence over time. Changes in other laboratory expenditure including for those without chronic conditions accounted for the remaining 0.9% growth per year. Increases in treatment prevalence were the largest driver of laboratory cost increases between 1996/97 and 2005/06. There are several possible contributors to increasing treatment prevalence, all of which can be expected to continue to put pressure on health care expenditures.

Flight Testing the Landing Radar for Mars Science Laboratory

NASA Image and Video Library

2011-06-21

A NASA Dryden Flight Research Center F/A-18 852 aircraft performs a roll during June 2011 flight tests of a Mars landing radar. A test model of the landing radar for NASA Mars Science Laboratory mission is inside a pod under the aircraft left wing.

[The usefulness of routine laboratory tests in the evaluation of sudden threat of pregnant woman and fetus in pre-eclampsia].

PubMed

Malarewicz, Andrzej; Gruszka, Olga; Szymkiewicz, Jadwiga; Rogala, Jerzy

2006-04-01

The fact that the progress of pre-eclampsia is highly unpredictable is the reason to run necessary monitoring, among others, by means of laboratory tests. Their aim is to determine explicitly if the pregnancy can be continued and terminated naturally or should be terminated by pre-term induced delivery or Caesarean section. There is a wide range of laboratory investigations recommended in pregnancy complicated by pre-eclampsia. The results reported in the literature though are controversial and inexplicit. The purpose of the research was to verify routine lab tests results used in decision making for emergency termination of pregnancy as a result of increased threatening clinical symptoms and to evaluate their usefulness in decision making to start delivery. The investigation covered 152 women who were divided into three groups. One consisted of 62 pregnant women with light form of pre-eclampsia, the other of 24 pregnant women with severe form of pre-eclampsia. The control group consisted of 66 healthy pregnant women. All pregnant women with pre-eclampsia diagnosed delivered by Caesarean section. The decision to perform the operation was based on biophysical findings of the fetus. At the moment of decision-making, blood was drawn for laboratory testing of the following parameters: systemic blood, coagulation parameters, total protein and protein fractios, non-protein nitrogen blood components, glucose, electrolytes, indicating enzymes and excretory enzymes of protein metabolism, lipid fractions. Routine lab tests performed in pre-eclampsia do not indicate distinct abnormalities the moment fetus life threatening clinical symptoms occur that enforce the decision of immediate delivery, the exception are the indicating enzymes. Acute clinical symptoms that endanger fetus life in pre-eclampsia correlate with distinct activity of AspAT, AIAT and LDH. Laboratory tests are of no prognostic value in the prediction of sudden worsening of the fetus condition in pre-eclampsia.

The Role of Laboratory Tests in Crohn’s Disease

PubMed Central

Cappello, Maria; Morreale, Gaetano Cristian

2016-01-01

In the past, laboratory tests were considered of limited value in Crohn’s disease (CD). In the era of biologics, laboratory tests have become essential to evaluate the inflammatory burden of the disease (C-reactive protein, fecal calprotectin) since symptoms-based scores are subjective, to predict the response to pharmacological options and the risk of relapse, to discriminate CD from ulcerative colitis, to select candidates to anti-tumor necrosis factors [screening tests looking for hepatitis B virus and hepatitis C virus status and latent tuberculosis], to assess the risk of adverse events (testing for thiopurine metabolites and thiopurine-methyltransferase activity), and to personalize and optimize therapy (therapeutic drug monitoring). Pharmacogenetics, though presently confined to the assessment of thiopurineme methyltransferase polymorphisms and hematological toxicity associated with thiopurine treatment, is a promising field that will contribute to a better understanding of the molecular mechanisms of the variability in response to the drugs used in CD with the attempt to expand personalized care and precision medicine strategies. PMID:27656094

Effect of Metformin and Flutamide on Anthropometric Indices and Laboratory Tests in Obese/Overweight PCOS Women under Hypocaloric Diet

PubMed Central

Amiri, Mania; Golsorkhtabaramiri, Masoumeh; Esmaeilzadeh, Sedigheh; Ghofrani, Faeze; Bijani, Ali; Ghorbani, Leila; Delavar, Moloud Agajani

2014-01-01

Background This study was designed to investigate the effect of metformin and flutamide alone or in combination with anthropometric indices and laboratory tests of obese/overweight PCOS women under hypocaloric diet. Methods This single blind clinical trial was performed on 120 PCOS women. At the beginning, hypocaloric diet was recommended for the patients. After one month while they were on the diet, the patients were randomly divided in 4 groups; metformin (500 mg, 3/day), flutamide (250 mg, 2/day), combined, metformin (500 mg, 3/day) with flutamide (250 mg, 2/day) and finally placebo group. The patients were treated for 6 months. Anthropometric indices and laboratory tests (fasting and glucose-stimulated insulin levels, lipid profile and androgens) were measured. A one-way ANOVA (Post Hoc) and paired t-test were performed to analyze data. A p ≤ 0.05 was considered statistically significant. Results After treatment, reduction in weight, BMI, hip circumference was significantly greater in the metformin group in comparison to other groups (p<0.05). In addition, the fasting insulin was significantly greater in metformin group and flutamide group in comparison to metformin+flutamide and placebo groups after treatment (p<0.05). Within groups, insulin level showed significant changes (before and after treatment) in metformin+flutamide group and LDL reduction was significant in flutamide group before and after treatment. Post hoc tukey and two-tailed with p≤0.05 were used to define statistical significance. Conclusion Using combination of metformin and flutamide improves anthropometric indices and laboratory tests in obese/overweight PCOS women under hypocaloric diet. PMID:25473629

Effect of Metformin and Flutamide on Anthropometric Indices and Laboratory Tests in Obese/Overweight PCOS Women under Hypocaloric Diet.

PubMed

Amiri, Mania; Golsorkhtabaramiri, Masoumeh; Esmaeilzadeh, Sedigheh; Ghofrani, Faeze; Bijani, Ali; Ghorbani, Leila; Delavar, Moloud Agajani

2014-10-01

This study was designed to investigate the effect of metformin and flutamide alone or in combination with anthropometric indices and laboratory tests of obese/overweight PCOS women under hypocaloric diet. This single blind clinical trial was performed on 120 PCOS women. At the beginning, hypocaloric diet was recommended for the patients. After one month while they were on the diet, the patients were randomly divided in 4 groups; metformin (500 mg, 3/day), flutamide (250 mg, 2/day), combined, metformin (500 mg, 3/day) with flutamide (250 mg, 2/day) and finally placebo group. The patients were treated for 6 months. Anthropometric indices and laboratory tests (fasting and glucose-stimulated insulin levels, lipid profile and androgens) were measured. A one-way ANOVA (Post Hoc) and paired t-test were performed to analyze data. A p ≤ 0.05 was considered statistically significant. After treatment, reduction in weight, BMI, hip circumference was significantly greater in the metformin group in comparison to other groups (p<0.05). In addition, the fasting insulin was significantly greater in metformin group and flutamide group in comparison to metformin+flutamide and placebo groups after treatment (p<0.05). Within groups, insulin level showed significant changes (before and after treatment) in metformin+flutamide group and LDL reduction was significant in flutamide group before and after treatment. Post hoc tukey and two-tailed with p≤0.05 were used to define statistical significance. Using combination of metformin and flutamide improves anthropometric indices and laboratory tests in obese/overweight PCOS women under hypocaloric diet.

10 CFR 707.12 - Specimen collection, handling and laboratory analysis for drug testing.

Code of Federal Regulations, 2011 CFR

2011-01-01

... drug testing. 707.12 Section 707.12 Energy DEPARTMENT OF ENERGY WORKPLACE SUBSTANCE ABUSE PROGRAMS AT DOE SITES Procedures § 707.12 Specimen collection, handling and laboratory analysis for drug testing... collection to final disposition of specimens, and testing laboratories shall use appropriate cutoff levels in...

10 CFR 707.12 - Specimen collection, handling and laboratory analysis for drug testing.

Code of Federal Regulations, 2010 CFR

2010-01-01

... drug testing. 707.12 Section 707.12 Energy DEPARTMENT OF ENERGY WORKPLACE SUBSTANCE ABUSE PROGRAMS AT DOE SITES Procedures § 707.12 Specimen collection, handling and laboratory analysis for drug testing... collection to final disposition of specimens, and testing laboratories shall use appropriate cutoff levels in...

10 CFR 707.12 - Specimen collection, handling and laboratory analysis for drug testing.

Code of Federal Regulations, 2014 CFR

2014-01-01

... drug testing. 707.12 Section 707.12 Energy DEPARTMENT OF ENERGY WORKPLACE SUBSTANCE ABUSE PROGRAMS AT DOE SITES Procedures § 707.12 Specimen collection, handling and laboratory analysis for drug testing... collection to final disposition of specimens, and testing laboratories shall use appropriate cutoff levels in...

10 CFR 707.12 - Specimen collection, handling and laboratory analysis for drug testing.

Code of Federal Regulations, 2012 CFR

2012-01-01

... drug testing. 707.12 Section 707.12 Energy DEPARTMENT OF ENERGY WORKPLACE SUBSTANCE ABUSE PROGRAMS AT DOE SITES Procedures § 707.12 Specimen collection, handling and laboratory analysis for drug testing... collection to final disposition of specimens, and testing laboratories shall use appropriate cutoff levels in...

10 CFR 707.12 - Specimen collection, handling and laboratory analysis for drug testing.

Code of Federal Regulations, 2013 CFR

2013-01-01

... drug testing. 707.12 Section 707.12 Energy DEPARTMENT OF ENERGY WORKPLACE SUBSTANCE ABUSE PROGRAMS AT DOE SITES Procedures § 707.12 Specimen collection, handling and laboratory analysis for drug testing... collection to final disposition of specimens, and testing laboratories shall use appropriate cutoff levels in...

40 CFR 270.63 - Permits for land treatment demonstrations using field test or laboratory analyses.

Code of Federal Regulations, 2011 CFR

2011-07-01

... demonstrations using field test or laboratory analyses. 270.63 Section 270.63 Protection of Environment... using field test or laboratory analyses. (a) For the purpose of allowing an owner or operator to meet... the field test or laboratory analyses, or as a two-phase facility permit covering the field tests, or...

40 CFR 270.63 - Permits for land treatment demonstrations using field test or laboratory analyses.

Code of Federal Regulations, 2010 CFR

2010-07-01

... demonstrations using field test or laboratory analyses. 270.63 Section 270.63 Protection of Environment... using field test or laboratory analyses. (a) For the purpose of allowing an owner or operator to meet... the field test or laboratory analyses, or as a two-phase facility permit covering the field tests, or...

40 CFR 270.63 - Permits for land treatment demonstrations using field test or laboratory analyses.

Code of Federal Regulations, 2014 CFR

2014-07-01

... demonstrations using field test or laboratory analyses. 270.63 Section 270.63 Protection of Environment... using field test or laboratory analyses. (a) For the purpose of allowing an owner or operator to meet... the field test or laboratory analyses, or as a two-phase facility permit covering the field tests, or...

40 CFR 270.63 - Permits for land treatment demonstrations using field test or laboratory analyses.

Code of Federal Regulations, 2013 CFR

2013-07-01

... demonstrations using field test or laboratory analyses. 270.63 Section 270.63 Protection of Environment... using field test or laboratory analyses. (a) For the purpose of allowing an owner or operator to meet... the field test or laboratory analyses, or as a two-phase facility permit covering the field tests, or...

40 CFR 270.63 - Permits for land treatment demonstrations using field test or laboratory analyses.

Code of Federal Regulations, 2012 CFR

2012-07-01

... demonstrations using field test or laboratory analyses. 270.63 Section 270.63 Protection of Environment... using field test or laboratory analyses. (a) For the purpose of allowing an owner or operator to meet... the field test or laboratory analyses, or as a two-phase facility permit covering the field tests, or...

A Review of the Centers for Disease Control and Prevention's Guidelines for the Clinical Laboratory Diagnosis of Lyme Disease.

PubMed

Miraglia, Caterina M

2016-12-01

The purpose of this paper is to review information regarding the current guidelines for the clinical laboratory diagnosis of Lyme disease as set forth by the Centers for Disease Control and Prevention (CDC) to chiropractic physicians and to discuss the clinical utility of this testing. The CDC's website was reviewed to determine what their current recommendations are for the clinical laboratory testing of Lyme disease. The CDC's established guidelines recommend the use of a 2-tiered serologic testing algorithm for the evaluation of patients with suspected Lyme disease. This review provides doctors of chiropractic with information to remain current with the CDC's recommended guidelines for Lyme disease testing because patients may present to their office with the associated signs and symptoms of Lyme disease.

19 CFR 151.73 - Importer's request for commercial laboratory test.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Hair § 151.73 Importer's request for commercial laboratory test. (a) Conditions for commercial test. If... request that a commercial test be made to determine the percentage clean yield of the wool or hair. (b... the wool or hair in dispute to be selected and tested by a commercial method approved by the...

19 CFR 151.73 - Importer's request for commercial laboratory test.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Hair § 151.73 Importer's request for commercial laboratory test. (a) Conditions for commercial test. If... request that a commercial test be made to determine the percentage clean yield of the wool or hair. (b... the wool or hair in dispute to be selected and tested by a commercial method approved by the...

19 CFR 151.73 - Importer's request for commercial laboratory test.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Hair § 151.73 Importer's request for commercial laboratory test. (a) Conditions for commercial test. If... request that a commercial test be made to determine the percentage clean yield of the wool or hair. (b... the wool or hair in dispute to be selected and tested by a commercial method approved by the...

19 CFR 151.73 - Importer's request for commercial laboratory test.

Code of Federal Regulations, 2014 CFR

2014-04-01

... Hair § 151.73 Importer's request for commercial laboratory test. (a) Conditions for commercial test. If... request that a commercial test be made to determine the percentage clean yield of the wool or hair. (b... the wool or hair in dispute to be selected and tested by a commercial method approved by the...

19 CFR 151.73 - Importer's request for commercial laboratory test.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Hair § 151.73 Importer's request for commercial laboratory test. (a) Conditions for commercial test. If... request that a commercial test be made to determine the percentage clean yield of the wool or hair. (b... the wool or hair in dispute to be selected and tested by a commercial method approved by the...

Laboratory diagnosis of tuberculosis: Advances in technology and drug susceptibility testing.

PubMed

Oommen, Seema; Banaji, Nandita

2017-01-01

There have been rapid technological advances in the detection of Mycobacterium tuberculosis and its drug susceptibility in clinical samples. These include advances in microscopic examination, in vitro culture and application of molecular techniques. The World Health Organization (WHO) has played a large role in evaluating these technologies for their efficacy and feasibility, especially in the developing countries. Amongst these, the Revised National Tuberculosis Control Programme (RNTCP), through its national network of designated microscopy centres and intermediate reference laboratories, has adopted certain technologies that are currently implemented in India. Advances in microscopy technology include fluorescent microscopy using light-emitting diode source, sodium hypochlorite microscopy and vital fluorescent staining of sputum smears. Automation of in vitro culture has markedly reduced the turnaround time (TAT), even in smear-negative samples, and permits simultaneous detection of resistant mutants. Molecular detection of drug resistance has further reduced the TAT, and the cartridge-based nucleic acid amplification test with its performance convenience and rapid results, appears poised to become the future of tuberculosis (TB) diagnosis in all settings, provided the cost of testing is reduced especially for use in private diagnostic settings. This article reviews technologies currently available for the diagnosis of TB, keeping in mind the WHO recommendations and the RNTCP practices. This is a thematic synthesis of data available on diagnosis in literature, preserving the conclusions of the primary studies.