CTEPP STANDARD OPERATING PROCEDURE FOR DETECTION AND QUANTIFICATION OF TARGET ANALYTES BY GAS CHROMATOGRAPHY/MASS SPECTROMETRY (GC/MS) (SOP-5.24)

EPA Science Inventory

This standard operating procedure describes the method used for the determination of target analytes in sample extracts and related quality assurance/quality control sample extracts generated in the CTEPP study.

[Quality control at the Istituto di Anatomia e Istologia patologica at the Università di Bologna].

PubMed

Alampi, G; Baroni, R; Berti, E; Ceccarelli, C; Dina, R; Eusebi, V; Giangaspero, F; Grigioni, F W; Lecce, S; Losi, L

1994-04-01

The growing importance in medical practice of a standardized diagnosis in cyto- and histopathology and the recent recommendations for the adoption of standardized schemes for quality control in anatomic pathology by International Committees stimulated the medical staff of the Institute of Anatomic Pathology of the University of Bologna to adopt a pertinent method. The method used by the Department of Pathology of the Yale University (New Haven, Connecticut, USA) was chosen. A Committee for the quality control was appointed and two kinds of controls were set up: an External Quality Assessment (review of the difficult cases by external experts, slide seminars) and an Internal Quality Assessment performed by the members of the Committee on the diagnostic and laboratory routine of the Institute. Such a survey is periodically monitored during the monthly meetings of the Committee and described in the monthly reports. The present paper illustrates the method adopted and the preliminary results obtained in order to stimulate the discussion of such a critical theme in contemporary Anatomic Pathology at a national level.

Quality Control of the Print with the Application of Statistical Methods

NASA Astrophysics Data System (ADS)

Simonenko, K. V.; Bulatova, G. S.; Antropova, L. B.; Varepo, L. G.

2018-04-01

The basis for standardizing the process of offset printing is the control of print quality indicators. The solution of this problem has various approaches, among which the most important are statistical methods. Practical implementation of them for managing the quality of the printing process is very relevant and is reflected in this paper. The possibility of using the method of constructing a Control Card to identify the reasons for the deviation of the optical density for a triad of inks in offset printing is shown.

Design, analysis, and interpretation of field quality-control data for water-sampling projects

USGS Publications Warehouse

Mueller, David K.; Schertz, Terry L.; Martin, Jeffrey D.; Sandstrom, Mark W.

2015-01-01

The report provides extensive information about statistical methods used to analyze quality-control data in order to estimate potential bias and variability in environmental data. These methods include construction of confidence intervals on various statistical measures, such as the mean, percentiles and percentages, and standard deviation. The methods are used to compare quality-control results with the larger set of environmental data in order to determine whether the effects of bias and variability might interfere with interpretation of these data. Examples from published reports are presented to illustrate how the methods are applied, how bias and variability are reported, and how the interpretation of environmental data can be qualified based on the quality-control analysis.

Method of analysis at the U.S. Geological Survey California Water Science Center, Sacramento Laboratory - determination of haloacetic acid formation potential, method validation, and quality-control practices

USGS Publications Warehouse

Zazzi, Barbara C.; Crepeau, Kathryn L.; Fram, Miranda S.; Bergamaschi, Brian A.

2005-01-01

An analytical method for the determination of haloacetic acid formation potential of water samples has been developed by the U.S. Geological Survey California Water Science Center Sacramento Laboratory. The haloacetic acid formation potential is measured by dosing water samples with chlorine under specified conditions of pH, temperature, incubation time, darkness, and residual-free chlorine. The haloacetic acids formed are bromochloroacetic acid, bromodichloroacetic acid, dibromochloroacetic acid, dibromoacetic acid, dichloroacetic acid, monobromoacetic acid, monochloroacetic acid, tribromoacetic acid, and trichloroacetic acid. They are extracted, methylated, and then analyzed using a gas chromatograph equipped with an electron capture detector. Method validation experiments were performed to determine the method accuracy, precision, and detection limit for each of the compounds. Method detection limits for these nine haloacetic acids ranged from 0.11 to 0.45 microgram per liter. Quality-control practices include the use of blanks, quality-control samples, calibration verification standards, surrogate recovery, internal standard, matrix spikes, and duplicates.

Langley Wind Tunnel Data Quality Assurance-Check Standard Results

NASA Technical Reports Server (NTRS)

Hemsch, Michael J.; Grubb, John P.; Krieger, William B.; Cler, Daniel L.

2000-01-01

A framework for statistical evaluation, control and improvement of wind funnel measurement processes is presented The methodology is adapted from elements of the Measurement Assurance Plans developed by the National Bureau of Standards (now the National Institute of Standards and Technology) for standards and calibration laboratories. The present methodology is based on the notions of statistical quality control (SQC) together with check standard testing and a small number of customer repeat-run sets. The results of check standard and customer repeat-run -sets are analyzed using the statistical control chart-methods of Walter A. Shewhart long familiar to the SQC community. Control chart results are presented for. various measurement processes in five facilities at Langley Research Center. The processes include test section calibration, force and moment measurements with a balance, and instrument calibration.

CTEPP STANDARD OPERATING PROCEDURE FOR CONDUCTING INTERNAL FIELD AUDITS AND QUALITY CONTROL (SOP-2.25)

EPA Science Inventory

This SOP describes the method for conducting internal field audits and quality control procedures. Internal field audits will be conducted to ensure the collection of high quality data. Internal field audits will be conducted by Field Auditors (the Field QA Officer and the Field...

Evaluating the Good Ontology Design Guideline (GoodOD) with the Ontology Quality Requirements and Evaluation Method and Metrics (OQuaRE)

PubMed Central

Duque-Ramos, Astrid; Boeker, Martin; Jansen, Ludger; Schulz, Stefan; Iniesta, Miguela; Fernández-Breis, Jesualdo Tomás

2014-01-01

Objective To (1) evaluate the GoodOD guideline for ontology development by applying the OQuaRE evaluation method and metrics to the ontology artefacts that were produced by students in a randomized controlled trial, and (2) informally compare the OQuaRE evaluation method with gold standard and competency questions based evaluation methods, respectively. Background In the last decades many methods for ontology construction and ontology evaluation have been proposed. However, none of them has become a standard and there is no empirical evidence of comparative evaluation of such methods. This paper brings together GoodOD and OQuaRE. GoodOD is a guideline for developing robust ontologies. It was previously evaluated in a randomized controlled trial employing metrics based on gold standard ontologies and competency questions as outcome parameters. OQuaRE is a method for ontology quality evaluation which adapts the SQuaRE standard for software product quality to ontologies and has been successfully used for evaluating the quality of ontologies. Methods In this paper, we evaluate the effect of training in ontology construction based on the GoodOD guideline within the OQuaRE quality evaluation framework and compare the results with those obtained for the previous studies based on the same data. Results Our results show a significant effect of the GoodOD training over developed ontologies by topics: (a) a highly significant effect was detected in three topics from the analysis of the ontologies of untrained and trained students; (b) both positive and negative training effects with respect to the gold standard were found for five topics. Conclusion The GoodOD guideline had a significant effect over the quality of the ontologies developed. Our results show that GoodOD ontologies can be effectively evaluated using OQuaRE and that OQuaRE is able to provide additional useful information about the quality of the GoodOD ontologies. PMID:25148262

Evaluation of mailed pediatric buccal cytobrushes for use in a case-control study of birth defects.

PubMed

Gallagher, Margaret L; Sturchio, Cynthia; Smith, Ashley; Koontz, Deborah; Jenkins, Mary M; Honein, Margaret A; Rasmussen, Sonja A

2011-07-01

Buccal cell collection is a convenient DNA collection method; however, little attention has been given to the quality of DNA obtained from pediatric populations. The purpose of this study was to determine the effect of a modified cytobrush collection method on the yield and quality of infant buccal DNA collected as part of a population-based case-control study of birth defects. METHODS Cytobrushes were collected from infants, mothers, and fathers using a standard collection method in 1997 to 2003 and a modified protocol that allows air-drying of the cytobrushes after collection from 2003 to the present. Yield and quality of DNA from 1057 cytobrushes was assessed by quantitative PCR and short tandem repeat (STR) genotyping, respectively. RESULTS Air-dried cytobrushes from infants had higher median DNA yields (1300 ng) and STR completion rates (99.5%) than standard collection method cytobrushes (60 ng and 59.5%, respectively). A subset of DNA aliquots was genotyped for six single nucleotide polymorphisms (SNPs). Aliquots from both collection methods that passed the quality protocol (DNA concentration >1 ng/μl, and successful amplification of ≥1 STR) had high genotype completion rates (99-100%). The median DNA yield following whole genome amplification was more than twofold higher for air-dried than standard collection specimens (p < 0.001). CONCLUSION Yield and quality of buccal DNA collected from infants are improved by using a method that incorporates air-drying; however, DNA collected by both methods is suitable for genotyping if stringent quality control procedures are instituted. These findings may be helpful for future epidemiologic studies of birth defects and other adverse pediatric outcomes. Copyright © 2011 Wiley-Liss, Inc.

Evaluating the Good Ontology Design Guideline (GoodOD) with the ontology quality requirements and evaluation method and metrics (OQuaRE).

PubMed

Duque-Ramos, Astrid; Boeker, Martin; Jansen, Ludger; Schulz, Stefan; Iniesta, Miguela; Fernández-Breis, Jesualdo Tomás

2014-01-01

To (1) evaluate the GoodOD guideline for ontology development by applying the OQuaRE evaluation method and metrics to the ontology artefacts that were produced by students in a randomized controlled trial, and (2) informally compare the OQuaRE evaluation method with gold standard and competency questions based evaluation methods, respectively. In the last decades many methods for ontology construction and ontology evaluation have been proposed. However, none of them has become a standard and there is no empirical evidence of comparative evaluation of such methods. This paper brings together GoodOD and OQuaRE. GoodOD is a guideline for developing robust ontologies. It was previously evaluated in a randomized controlled trial employing metrics based on gold standard ontologies and competency questions as outcome parameters. OQuaRE is a method for ontology quality evaluation which adapts the SQuaRE standard for software product quality to ontologies and has been successfully used for evaluating the quality of ontologies. In this paper, we evaluate the effect of training in ontology construction based on the GoodOD guideline within the OQuaRE quality evaluation framework and compare the results with those obtained for the previous studies based on the same data. Our results show a significant effect of the GoodOD training over developed ontologies by topics: (a) a highly significant effect was detected in three topics from the analysis of the ontologies of untrained and trained students; (b) both positive and negative training effects with respect to the gold standard were found for five topics. The GoodOD guideline had a significant effect over the quality of the ontologies developed. Our results show that GoodOD ontologies can be effectively evaluated using OQuaRE and that OQuaRE is able to provide additional useful information about the quality of the GoodOD ontologies.

WHO Working Group on revision of the Manual of Laboratory Methods for Testing DTP Vaccines-Report of two meetings held on 20-21 July 2006 and 28-30 March 2007, Geneva, Switzerland.

PubMed

Corbel, Michael J; Das, Rose Gaines; Lei, Dianliang; Xing, Dorothy K L; Horiuchi, Yoshinobu; Dobbelaer, Roland

2008-04-07

This report reflects the discussion and conclusions of a WHO group of experts from National Regulatory Authorities (NRAs), National Control Laboratories (NCLs), vaccine industries and other relevant institutions involved in standardization and control of diphtheria, tetanus and pertussis vaccines (DTP), held on 20-21 July 2006 and 28-30 March 2007, in Geneva Switzerland for the revision of WHO Manual for quality control of DTP vaccines. Taking into account recent developments and standardization in quality control methods and the revision of WHO recommendations for D, T, P vaccines, and a need for updating the manual has been recognized. In these two meetings the current situation of quality control methods in terms of potency, safety and identity tests for DTP vaccines and statistical analysis of data were reviewed. Based on the WHO recommendations and recent validation of testing methods, the content of current manual were reviewed and discussed. The group agreed that the principles to be observed in selecting methods included identifying those critical for assuring safety, efficacy and quality and which were consistent with WHO recommendations/requirements. Methods that were well recognized but not yet included in current Recommendations should be taken into account. These would include in vivo and/or in vitro methods for determining potency, safety testing and identity. The statistical analysis of the data should be revised and updated. It was noted that the mouse based assays for toxoid potency were still quite widely used and it was desirable to establish appropriate standards for these to enable the results to be related to the standard guinea pig assays. The working group was met again to review the first drafts and to input further suggestions or amendments to the contributions of the drafting groups. The revised manual was to be finalized and published by WHO.

16 CFR 1000.29 - Directorate for Engineering Sciences.

Code of Federal Regulations, 2010 CFR

2010-01-01

... standards, product safety tests and test methods, performance criteria, design specifications, and quality control standards for consumer products, based on engineering and scientific methods. It conducts... consumer interest groups. The Directorate conducts human factors studies and research of consumer product...

16 CFR 1000.29 - Directorate for Engineering Sciences.

Code of Federal Regulations, 2012 CFR

2012-01-01

... standards, product safety tests and test methods, performance criteria, design specifications, and quality control standards for consumer products, based on engineering and scientific methods. It conducts... consumer interest groups. The Directorate conducts human factors studies and research of consumer product...

The Manufacture, Shipping and Receiving and Quality Control of Rodent Bedding Materials

NASA Technical Reports Server (NTRS)

Kraft, Lisbeth M.

1980-01-01

The criteria for rodent bedding and nesting materials are discussed. The literature is reviewed regarding sources of bedding materials, manufacturing methods, quality control, procedures (microbiological, physical and chemical), storage, methods, shipment, methods of use and disposal, current knowledge concerning bedding effects on animals as related to research and testing and legal aspects. Future needs, especially with respect to the promulgation of standards, also are addressed.

Laboratory validation of four black carbon measurement methods for the determination of non-volatile particulate matter (PM) mass emissions . . .

EPA Science Inventory

A laboratory-scale experimental program was designed to standardize each of four black carbon measurement methods, provide appropriate quality assurance/control procedures for these techniques, and compare measurements made by these methods to a NIST traceable standard (filter gr...

Quality Control Method for a Micro-Nano-Channel Microfabricated Device

NASA Technical Reports Server (NTRS)

Grattoni, Alessandro; Ferrari, Mauro; Li, Xuewu

2012-01-01

A variety of silicon-fabricated devices is used in medical applications such as drug and cell delivery, and DNA and protein separation and analysis. When a fluidic device inlet is connected to a compressed gas reservoir, and the outlet is at a lower pressure, a gas flow occurs through the membrane toward the outside. The method relies on the measurement of the gas pressure over the elapsed time inside the upstream and downstream environments. By knowing the volume of the upstream reservoir, the gas flow rate through the membrane over the pressure drop can be calculated. This quality control method consists of measuring the gas flow through a device and comparing the results with a standard curve, which can be obtained by testing standard devices. Standard devices can be selected through a variety of techniques, both destructive and nondestructive, such as SEM, AFM, and standard particle filtration.

Topographic and hydrographic survey data for the São Francisco River near Torrinha, Bahia, Brazil, 2014

USGS Publications Warehouse

Fosness, Ryan L.; Dietsch, Benjamin J.

2015-10-21

This report presents the surveying techniques and data-processing methods used to collect, process, and disseminate topographic and hydrographic data. All standard and non‑standard data-collection methods, techniques, and data process methods were documented. Additional discussion describes the quality-assurance and quality-control elements used in this study, along with the limitations for the Torrinha-Itacoatiara study reach data. The topographic and hydrographic geospatial data are published along with associated metadata.

Quality Space and Launch Requirements Addendum to AS9100C

DTIC Science & Technology

2015-03-05

45 8.9.1 Statistical Process Control (SPC) .......................................................................... 45 8.9.1.1 Out of Control...Systems Center SME Subject Matter Expert SOW Statement of Work SPC Statistical Process Control SPO System Program Office SRP Standard Repair...individual data exceeding the control limits. Control limits are developed using standard statistical methods or other approved techniques and are based on

40 CFR 75.21 - Quality assurance and quality control requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

..., as defined in § 72.2, k=2) of plus or minus 1.0 percent (calculated combined standard uncertainty of... system according to the quality assurance and quality control procedures in appendix B of this part. (2... requirements of Method 2, 6C, 7E, or 3A in Appendices A-1, A-2 and A-4 to part 60 of this chapter (supplemented...

Modeling Canadian Quality Control Test Program for Steroid Hormone Receptors in Breast Cancer: Diagnostic Accuracy Study.

PubMed

Pérez, Teresa; Makrestsov, Nikita; Garatt, John; Torlakovic, Emina; Gilks, C Blake; Mallett, Susan

The Canadian Immunohistochemistry Quality Control program monitors clinical laboratory performance for estrogen receptor and progesterone receptor tests used in breast cancer treatment management in Canada. Current methods assess sensitivity and specificity at each time point, compared with a reference standard. We investigate alternative performance analysis methods to enhance the quality assessment. We used 3 methods of analysis: meta-analysis of sensitivity and specificity of each laboratory across all time points; sensitivity and specificity at each time point for each laboratory; and fitting models for repeated measurements to examine differences between laboratories adjusted by test and time point. Results show 88 laboratories participated in quality control at up to 13 time points using typically 37 to 54 histology samples. In meta-analysis across all time points no laboratories have sensitivity or specificity below 80%. Current methods, presenting sensitivity and specificity separately for each run, result in wide 95% confidence intervals, typically spanning 15% to 30%. Models of a single diagnostic outcome demonstrated that 82% to 100% of laboratories had no difference to reference standard for estrogen receptor and 75% to 100% for progesterone receptor, with the exception of 1 progesterone receptor run. Laboratories with significant differences to reference standard identified with Generalized Estimating Equation modeling also have reduced performance by meta-analysis across all time points. The Canadian Immunohistochemistry Quality Control program has a good design, and with this modeling approach has sufficient precision to measure performance at each time point and allow laboratories with a significantly lower performance to be targeted for advice.

24 CFR 200.935 - Administrator qualifications and procedures for HUD building products certification programs.

Code of Federal Regulations, 2011 CFR

2011-04-01

... guidelines in any quality assurance review: (1) ASQC Q9000-1-1994 Quality Management and Quality Assurance... Systems—Model for Quality Assurance in Final Inspection and Test; (5) ASQC Q9004-1-1994 Quality Management... in interpreting testing standards, test methods, evaluating test reports and quality control programs...

A new method for long-term storage of titred microbial standard solutions suitable for microbiologic quality control activities of pharmaceutical companies.

PubMed

Chiellini, Carolina; Mocali, Stefano; Fani, Renato; Ferro, Iolanda; Bruschi, Serenella; Pinzani, Alessandro

2016-08-01

Commercially available lyophilized microbial standards are expensive and subject to reduction in cell viability due to freeze-drying stress. Here we introduce an inexpensive and straightforward method for in-house microbial standard preparation and cryoconservation that preserves constant cell titre and cell viability over 14 months.

[Study on quality standard of Mucuna pruriens var. utilis].

PubMed

Wu, Shi-Hong; Jiang, Wei-Zhe; Lv, Li; Wu, Ling-Ling; Lv, Cong; Shi, Xiao-Xia; Su, Gui-Liang

2009-03-01

To provide scientific basis for the utilization and development of Mucuna pruriens var. utilis by establishing its quality control standard. The bioactive constituents were analyzed by TLC and HPLC. Moisture, ash and the extracts of Mucuna pruriens var. utilis were all determined. The TLC spots of levodopa had similar color with the control group at the same position. The results of HPLC quantitative analysis showed that the linear range of levodopa was 26.45 to approximately 132.25 microg/mL, r = 0.9992, and the average recovery rate was 103.8%, RSD = 1.85%. This method is convenient, accurate, reliable with good reproducibility, so it can be used to establish quality standard for the medicinal material.

Quality control ranges for testing broth microdilution susceptibility of Flavobacterium columnare and F. psychrophilium to nine antimicrobials

USDA-ARS?s Scientific Manuscript database

A multi-laboratory broth microdilution method trial was performed to standardize the specialized test conditions required for fish pathogens Flavobacterium columnare and F. pyschrophilum. Nine laboratories tested the quality control (QC) strains Escherichia coli ATCC 25922 and Aeromonas salmonicid...

External Standards or Standard Addition? Selecting and Validating a Method of Standardization

NASA Astrophysics Data System (ADS)

Harvey, David T.

2002-05-01

A common feature of many problem-based laboratories in analytical chemistry is a lengthy independent project involving the analysis of "real-world" samples. Students research the literature, adapting and developing a method suitable for their analyte, sample matrix, and problem scenario. Because these projects encompass the complete analytical process, students must consider issues such as obtaining a representative sample, selecting a method of analysis, developing a suitable standardization, validating results, and implementing appropriate quality assessment/quality control practices. Most textbooks and monographs suitable for an undergraduate course in analytical chemistry, however, provide only limited coverage of these important topics. The need for short laboratory experiments emphasizing important facets of method development, such as selecting a method of standardization, is evident. The experiment reported here, which is suitable for an introductory course in analytical chemistry, illustrates the importance of matrix effects when selecting a method of standardization. Students also learn how a spike recovery is used to validate an analytical method, and obtain a practical experience in the difference between performing an external standardization and a standard addition.

A real time quality control application for animal production by image processing.

PubMed

Sungur, Cemil; Özkan, Halil

2015-11-01

Standards of hygiene and health are of major importance in food production, and quality control has become obligatory in this field. Thanks to rapidly developing technologies, it is now possible for automatic and safe quality control of food production. For this purpose, image-processing-based quality control systems used in industrial applications are being employed to analyze the quality of food products. In this study, quality control of chicken (Gallus domesticus) eggs was achieved using a real time image-processing technique. In order to execute the quality control processes, a conveying mechanism was used. Eggs passing on a conveyor belt were continuously photographed in real time by cameras located above the belt. The images obtained were processed by various methods and techniques. Using digital instrumentation, the volume of the eggs was measured, broken/cracked eggs were separated and dirty eggs were determined. In accordance with international standards for classifying the quality of eggs, the class of separated eggs was determined through a fuzzy implication model. According to tests carried out on thousands of eggs, a quality control process with an accuracy of 98% was possible. © 2014 Society of Chemical Industry.

Coordination and standardization of federal sedimentation activities

USGS Publications Warehouse

Glysson, G. Douglas; Gray, John R.

1997-01-01

- precipitation information critical to water resources management. Memorandum M-92-01 covers primarily freshwater bodies and includes activities, such as "development and distribution of consensus standards, field-data collection and laboratory analytical methods, data processing and interpretation, data-base management, quality control and quality assurance, and water- resources appraisals, assessments, and investigations." Research activities are not included.

Statistical Process Control Charts for Measuring and Monitoring Temporal Consistency of Ratings

ERIC Educational Resources Information Center

Omar, M. Hafidz

2010-01-01

Methods of statistical process control were briefly investigated in the field of educational measurement as early as 1999. However, only the use of a cumulative sum chart was explored. In this article other methods of statistical quality control are introduced and explored. In particular, methods in the form of Shewhart mean and standard deviation…

Guidelines for the detection of Trichinella larvae at the slaughterhouse in a quality assurance system.

PubMed

Rossi, Patrizia; Pozio, Edoardo

2008-01-01

The European Community Regulation (EC) No. 2075/2005 lays down specific rules on official controls for the detection of Trichinella in fresh meat for human consumption, recommending the pooled-sample digestion method as the reference method. The aim of this document is to provide specific guidance to implement an appropriate Trichinella digestion method by a laboratory accredited according to the ISO/IEC 17025:2005 international standard, and performing microbiological testing following the EA-04/10:2002 international guideline. Technical requirements for the correct implementation of the method, such as the personnel competence, specific equipments and reagents, validation of the method, reference materials, sampling, quality assurance of results and quality control of performance are provided, pointing out the critical control points for the correct implementation of the digestion method.

[Implementation of the technical requirements of the UNE-EN-ISO 15189 quality standard in a mycobacterial laboratory].

PubMed

Guna Serrano, M del Remedio; Ocete Mochón, M Dolores; Lahiguera, M José; Bresó, M Carmen; Gimeno Cardona, Concepción

2013-02-01

The UNE-EN-ISO 15189:2007 standard defines the requirements for quality and competence that must be met by medical laboratories. These laboratories should use this international standard to develop their own quality management systems and to evaluate their own competencies; in turn, this standard will be used by accreditation bodies to confirm or recognize the laboratories' competence. In clinical microbiology laboratories, application of the standard implies the implementation of the technical and specific management requirements that must be met to achieve optimal quality when carrying out microbiological tests. In Spain, accreditation is granted by the Spanish Accreditation Body (Entidad Nacional de Acreditación). This review aims to discuss the practical application of the standard's technical requirements in mycobacterial laboratory. Firstly, we define the scope of accreditation. Secondly, we specify how the items of the standard on personnel management, control of equipment, environmental facilities, method validation, internal controls and customer satisfaction surveys were developed and implemented in our laboratory. Copyright © 2013 Elsevier España, S.L. All rights reserved.

[Quality control assessments of feces examination for schistosomiasis in province-level laboratories of Zhejiang Province].

PubMed

Chen, Wen; Zhu, Ming-Dong; Yan, Xiao-Lan; Lin, Li-Jun; Zhang, Jian-Feng; Li, Li; Wen, Li-Yong

2011-06-01

To understand and evaluate the quality of feces examination for schistosomiasis in province-level laboratories of Zhejiang Province. With the single-blind method, the stool samples were detected by the stool hatching method and sediment detection method. In the 3 quality control assessments in 2006, 2008 and 2009, most laboratories finished the examinations on time. The accordance rates of detections were 88.9%, 100% and 93.9%, respectively. The province-level laboratories for schistosomiasis feces examination of Zhejiang Province is coming into standardization, and the techniques of schistosomiasis feces examination are optimized gradually.

Writing standard operating procedures (SOPs) for cryostorage protocols: using shoot meristem cryopreservation as an example.

PubMed

Harding, Keith; Benson, Erica E

2015-01-01

Standard operating procedures are a systematic way of making sure that biopreservation processes, tasks, protocols, and operations are correctly and consistently performed. They are the basic documents of biorepository quality management systems and are used in quality assurance, control, and improvement. Methodologies for constructing workflows and writing standard operating procedures and work instructions are described using a plant cryopreservation protocol as an example. This chapter is pertinent to other biopreservation sectors because how methods are written, interpreted, and implemented can affect the quality of storage outcomes.

Performance and quality-control standards for composite floor, wall, and truss framing

Treesearch

Gerald A. Koenigshof

1985-01-01

Users must be assured that composite structural members are satisfactory for their intended purposes. Standards are provided for strength, stiffness, durability, and dimensional stability of composite floor, wall, and truss-framing members. Methods for enforcing compliance with the standards are suggested.

Category 1 external quality assessment program for serum creatinine.

PubMed

González-Lao, Elisabet; Díaz-Garzón, Jorge; Corte, Zoraida; Ricós, Carmen; Perich, Carmen; Álvarez, Virtudes; Simón, Margarita; Minchinela, Joana; García-Lario, José Vicente; Boned, Beatriz; Biosca, Carmen; Cava, Fernando; Fernández-Fernández, Pilar; Fernández-Calle, Pilar

2017-03-01

The Commission of Analytical Quality and the Committee of External Quality Programs of Spanish Society of Laboratory Medicine (SEQC) in collaboration with the Dutch Foundation for the Quality organized the first national category 1 External Quality Assessment Programs (EQAP) pilot study. The aim is to evaluate the standardization of serum creatinine measurements in the Spanish laboratories through a category 1 external quality assurance program with commutable material and reference method assigned values. A total of 87 Spanish laboratories were involved in this program in 2015. Each day a sample control was measured by duplicate during 6 consecutive days. Percentage deviations and coefficients of variation obtained were compared with quality specifications derived from biological variation. A total of 1044 creatinine results were obtained. Laboratories were coded in 11 different method-traceability combinations. Only enzymatic methods get all results within the acceptability limits. To participate in a category 1 EQAP is a valuable tool to assess the standardization degree in our country; a big effort should be made to promote laboratories to change their procedures and to use enzymatic creatinine methods, in order to achieve a satisfactory standardization degree for this important analyte.

Quality Control of an OSCE Using Generalizability Theory and Many-Faceted Rasch Measurement

ERIC Educational Resources Information Center

Iramaneerat, Cherdsak; Yudkowsky, Rachel; Myford, Carol M.; Downing, Steven M.

2008-01-01

An Objective Structured Clinical Examination (OSCE) is an effective method for evaluating competencies. However, scores obtained from an OSCE are vulnerable to many potential measurement errors that cases, items, or standardized patients (SPs) can introduce. Monitoring these sources of errors is an important quality control mechanism to ensure…

Trichinella diagnostics and control: mandatory and best practices for ensuring food safety.

PubMed

Gajadhar, Alvin A; Pozio, Edoardo; Gamble, H Ray; Nöckler, Karsten; Maddox-Hyttel, Charlotte; Forbes, Lorry B; Vallée, Isabelle; Rossi, Patrizia; Marinculić, Albert; Boireau, Pascal

2009-02-23

Because of its role in human disease, there are increasing global requirements for reliable diagnostic and control methods for Trichinella in food animals to ensure meat safety and to facilitate trade. Consequently, there is a need for standardization of methods, programs, and best practices used in the control of Trichinella and trichinellosis. This review article describes the biology and epidemiology of Trichinella, and describes recommended test methods as well as modified and optimized procedures that are used in meat inspection programs. The use of ELISA for monitoring animals for infection in various porcine and equine pre- and post-slaughter programs, including farm or herd certification programs is also discussed. A brief review of the effectiveness of meat processing methods, such as freezing, cooking and preserving is provided. The importance of proper quality assurance and its application in all aspects of a Trichinella diagnostic system is emphasized. It includes the use of international quality standards, test validation and standardization, critical control points, laboratory accreditation, certification of analysts and proficiency testing. Also described, are the roles and locations of international and regional reference laboratories for trichinellosis where expert advice and support on research and diagnostics are available.

Validation of a method for the determination of zolpidem in human plasma using LC with fluorescence detection.

PubMed

Ring, P R; Bostick, J M

2000-04-01

A sensitive and selective high-performance liquid chromatography (HPLC) method was developed for the determination of zolpidem in human plasma. Zolpidem and the internal standard (trazodone) were extracted from human plasma that had been made basic. The basic sample was loaded onto a conditioned Bond Elut C18 cartridge, rinsed with water and eluted with methanol. Forty microliters were then injected onto the LC system. Separation was achieved on a C18 column (150 x 4.6 mm, 5 microm) with a mobile phase composed of acetonitrile:50 mM potassium phosphate monobasic at pH 6.0 (4:6, v/v). Detection was by fluorescence, with excitation at 254 nm and emission at 400 nm. The retention times of zolpidem and internal standard were approximately 4.7 and 5.3 min, respectively. The LC run time was 8 min. The assay was linear in concentration range 1-400 ng/ml for zolpidem in human plasma. The analysis of quality control samples for zolpidem (3, 30, and 300 ng/ml) demonstrated excellent precision with relative standard deviations (RSD) of 3.7, 4.6, and 3.0%, respectively (n = 18). The method was accurate with all intraday (n = 6) and overall (n = 18) mean concentrations within 5.8% from nominal at all quality control sample concentrations. This method was also performed using a Gilson Aspec XL automated sample processor and autoinjector. The samples were manually fortified with internal standard and made basic. The aspec then performed the solid phase extraction and made injections of the samples onto the LC system. Using the automated procedure for analysis, quality control samples for zolpidem (3, 30, and 300 ng/ml) demonstrated acceptable precision with RSD values of 9.0, 4.9, and 5.1%, respectively (n = 12). The method was accurate with all intracurve (n = 4) and overall (n = 12) mean values being less than 10.8% from nominal at all quality control sample concentrations.

Technology transfer through a network of standard methods and recommended practices - The case of petrochemicals

NASA Astrophysics Data System (ADS)

Batzias, Dimitris F.; Karvounis, Sotirios

2012-12-01

Technology transfer may take place in parallel with cooperative action between companies participating in the same organizational scheme or using one another as subcontractor (outsourcing). In this case, cooperation should be realized by means of Standard Methods and Recommended Practices (SRPs) to achieve (i) quality of intermediate/final products according to specifications and (ii) industrial process control as required to guarantee such quality with minimum deviation (corresponding to maximum reliability) from preset mean values of representative quality parameters. This work deals with the design of the network of SRPs needed in each case for successful cooperation, implying also the corresponding technology transfer, effectuated through a methodological framework developed in the form of an algorithmic procedure with 20 activity stages and 8 decision nodes. The functionality of this methodology is proved by presenting the path leading from (and relating) a standard test method for toluene, as petrochemical feedstock in the toluene diisocyanate production, to the (6 generations distance upstream) performance evaluation of industrial process control systems (ie., from ASTM D5606 to BS EN 61003-1:2004 in the SRPs network).

Quantitative estimation of dust fall and smoke particles in Quetta Valley*

PubMed Central

Sami, Muhammad; Waseem, Amir; Akbar, Sher

2006-01-01

Tightening of air quality standards for populated urban areas has led to increasing attention to assessment of air quality management areas, where violation of air quality standards occurs, and development of control strategies to eliminate such violation of air quality standards. The Quetta urban area is very densely built and has heavy motorized traffic. The increase of emissions mainly from traffic and industry are responsible for the increase in atmospheric pollution levels during the last years. The dust examined in the current study was collected by both deposit gauge and Petri dish methods at various sites of Quetta Valley. Smoke particles were obtained by bladder method from the exhausts of various types of motor vehicles. The concentration of lead found in the smoke ranged from 1.5×10−6 to 4.5×10−6. PMID:16773727

Effect of poor control of film processors on mammographic image quality.

PubMed

Kimme-Smith, C; Sun, H; Bassett, L W; Gold, R H

1992-11-01

With the increasingly stringent standards of image quality in mammography, film processor quality control is especially important. Current methods are not sufficient for ensuring good processing. The authors used a sensitometer and densitometer system to evaluate the performance of 22 processors at 16 mammographic facilities. Standard sensitometric values of two films were established, and processor performance was assessed for variations from these standards. Developer chemistry of each processor was analyzed and correlated with its sensitometric values. Ten processors were retested, and nine were found to be out of calibration. The developer components of hydroquinone, sulfites, bromide, and alkalinity varied the most, and low concentrations of hydroquinone were associated with lower average gradients at two facilities. Use of the sensitometer and densitometer system helps identify out-of-calibration processors, but further study is needed to correlate sensitometric values with developer component values. The authors believe that present quality control would be improved if sensitometric or other tests could be used to identify developer components that are out of calibration.

CALL FOR PAPERS: 13th International Conference on Force and Mass Measurement

NASA Astrophysics Data System (ADS)

1992-01-01

10 14 May 1993, Helsinki Fair Centre, Finland Scope of the Conference The Conference reports and reviews the state of the art and future trends in force and mass measurements in science and industry. Emphasis is on the applications of new methods, current problems in calibration and quality control, as well as on advancements in new sensor technologies and industrial application of force and mass measurements. Main Themes and Topics 1. The state of the art and development trends in force and mass measurements Development and stability of high level mass standards Mass comparators and force standard machine New research topics in mass and force 2. Calibration and quality control Calibration methods Estimation of uncertainties and classification of accuracies Relations between calibration, testing and quality control Requirements for quality control Verification of weighing instruments and their main devices 3. Application of force and mass measurements Automatic weighing Mass flow measurements Quality control in process industry Sensor technologies Practical applications Special applications in industry, trade, etc. Deadline for submission of abstracts: 30 June 1992. For further information please contact: Finnish Society of Automation, Asemapäällikönkatu 12C, SF-00520 HELSINKI, Finland Phone: Int. +3580 1461 644, Fax: Int. +3580 1461 650

Computer program CDCID: an automated quality control program using CDC update

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

Singer, G.L.; Aguilar, F.

1984-04-01

A computer program, CDCID, has been developed in coordination with a quality control program to provide a highly automated method of documenting changes to computer codes at EG and G Idaho, Inc. The method uses the standard CDC UPDATE program in such a manner that updates and their associated documentation are easily made and retrieved in various formats. The method allows each card image of a source program to point to the document which describes it, who created the card, and when it was created. The method described is applicable to the quality control of computer programs in general. Themore » computer program described is executable only on CDC computing systems, but the program could be modified and applied to any computing system with an adequate updating program.« less

Improved quality monitoring of multi-center acupuncture clinical trials in China

PubMed Central

2009-01-01

Background In 2007, the Chinese Science Division of the State Administration of Traditional Chinese Medicine(TCM) convened a special conference to discuss quality control for TCM clinical research. Control and assurance standards were established to guarantee the quality of clinical research. This paper provides practical guidelines for implementing strict and reproducible quality control for acupuncture randomized controlled trials (RCTs). Methods A standard quality control program (QCP) was established to monitor the quality of acupuncture trials. Case report forms were designed; qualified investigators, study personnel and data management personnel were trained. Monitors, who were directly appointed by the project leader, completed the quality control programs. They guaranteed data accuracy and prevented or detected protocol violations. Clinical centers and clinicians were audited, the randomization system of the centers was inspected, and the treatment processes were audited as well. In addition, the case report forms were reviewed for completeness and internal consistency, the eligibility and validity of the patients in the study was verified, and data was monitored for compliance and accuracy. Results and discussion The monitors complete their reports and submit it to quality assurance and the sponsors. Recommendations and suggestions are made for improving performance. By holding regular meetings to discuss improvements in monitoring standards, the monitors can improve quality and efficiency. Conclusions Supplementing and improving the existed guidelines for quality monitoring will ensure that large multi-centre acupuncture clinical trials will be considered as valid and scientifically stringent as pharmaceutical clinical trials. It will also develop academic excellence and further promote the international recognition of acupuncture. PMID:20035630

[Study on the optimization of monitoring indicators of drinking water quality during health supervision].

PubMed

Ye, Bixiong; E, Xueli; Zhang, Lan

2015-01-01

To optimize non-regular drinking water quality indices (except Giardia and Cryptosporidium) of urban drinking water. Several methods including drinking water quality exceed the standard, the risk of exceeding standard, the frequency of detecting concentrations below the detection limit, water quality comprehensive index evaluation method, and attribute reduction algorithm of rough set theory were applied, redundancy factor of water quality indicators were eliminated, control factors that play a leading role in drinking water safety were found. Optimization results showed in 62 unconventional water quality monitoring indicators of urban drinking water, 42 water quality indicators could be optimized reduction by comprehensively evaluation combined with attribute reduction of rough set. Optimization of the water quality monitoring indicators and reduction of monitoring indicators and monitoring frequency could ensure the safety of drinking water quality while lowering monitoring costs and reducing monitoring pressure of the sanitation supervision departments.

[Quality process control system of Chinese medicine preparation based on "holistic view"].

PubMed

Wang, Ya-Qi; Jiao, Jiao-Jiao; Wu, Zhen-Feng; Zheng, Qin; Yang, Ming

2018-01-01

"High quality, safety and effectiveness" are the primary principles for the pharmaceutical research and development process in China. The quality of products relies not only on the inspection method, but also on the design and development, process control and standardized management. The quality depends on the process control level. In this paper, the history and current development of quality control of traditional Chinese medicine (TCM) preparations are reviewed systematically. Based on the development model of international drug quality control and the misunderstanding of quality control of TCM preparations, the reasons for impacting the homogeneity of TCM preparations are analyzed and summarized. According to TCM characteristics, efforts were made to control the diversity of TCM, make "unstable" TCM into "stable" Chinese patent medicines, put forward the concepts of "holistic view" and "QbD (quality by design)", so as to create the "holistic, modular, data, standardized" model as the core of TCM preparation quality process control model. Scientific studies shall conform to the actual production of TCM preparations, and be conducive to supporting advanced equipment and technology upgrade, thoroughly applying the scientific research achievements in Chinese patent medicines, and promoting the cluster application and transformation application of TCM pharmaceutical technology, so as to improve the quality and effectiveness of the TCM industry and realize the green development. Copyright© by the Chinese Pharmaceutical Association.

New strategy to improve quality control of Montenegro skin test at the production level.

PubMed

Guedes, Deborah Carbonera; Minozzo, João Carlos; Pasquali, Aline Kuhn Sbruzzi; Faulds, Craig; Soccol, Carlos Ricardo; Thomaz-Soccol, Vanete

2017-01-01

The production of the Montenegro antigen for skin test poses difficulties regarding quality control. Here, we propose that certain animal models reproducing a similar immune response to humans may be used in the quality control of Montenegro antigen production. Fifteen Cavia porcellus (guinea pigs) were immunized with Leishmania amazonensis or Leishmania braziliensis , and, after 30 days, they were skin tested with standard Montenegro antigen. To validate C. porcellus as an animal model for skin tests, eighteen Mesocricetus auratus (hamsters) were infected with L. amazonensis or L. braziliensis , and, after 45 days, they were skin tested with standard Montenegro antigen. Cavia porcellus immunized with L. amazonensis or L. braziliensis , and hamsters infected with the same species presented induration reactions when skin tested with standard Montenegro antigen 48-72h after the test. The comparison between immunization methods and immune response from the two animal species validated C. porcellus as a good model for Montenegro skin test, and the model showed strong potential as an in vivo model in the quality control of the production of Montenegro antigen.

Training of U.S. Air Traffic Controllers. (IDA Report No. R-206).

ERIC Educational Resources Information Center

Henry, James H.; And Others

The report reviews the evolution of existing national programs for air traffic controller training, estimates the number of persons requiring developmental and supplementary training, examines present controller selection and training programs, investigates performance measurement methods, considers standardization and quality control, discusses…

[Analysis of the results of the SEIMC External Quality Control Program for HIV-1 and HCV viral loads. Year 2008].

PubMed

Mira, Nieves Orta; Serrano, María del Remedio Guna; Martínez, José Carlos Latorre; Ovies, María Rosario; Pérez, José L; Cardona, Concepción Gimeno

2010-01-01

Human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV) viral load determinations are among the most relevant markers for the follow up of patients infected with these viruses. External quality control tools are crucial to ensure the accuracy of results obtained by microbiology laboratories. This article summarized the results obtained from the 2008 SEIMC External Quality Control Program for HIV-1 and HCV viral loads. In the HIV-1 program, a total of five standards were sent. One standard consisted in seronegative human plasma, while the remaining four contained plasma from 3 different viremic patients, in the range of 2-5 log(10) copies/mL; two of these standards were identical aiming to determine repeatability. The specificity was complete for all commercial methods, and no false positive results were reported by the participants. A significant proportion of the laboratories (24% on average) obtained values out of the accepted range (mean +/- 0.2 log(10) copies/mL), depending on the standard and on the method used for quantification. Repeatability was very good, with up to 95% of laboratories reporting results within the limits (D < 0.5 log(10) copias/mL). The HCV program consisted of two standards with different viral load contents. Most of the participants (88,7%) obtained results within the accepted range (mean +/- 1.96 SD log(10) UI/mL). Post-analytical errors due to mistranscription of the results were detected for HCV, but not for the HIV-1 program. Data from this analysis reinforce the utility of proficiency programmes to ensure the quality of the results obtained by a particular laboratory, as well as the importance of the post-analytical phase on the overall quality. Due to the remarkable interlaboratory variability, it is advisable to use the same method and the same laboratory for patient follow up. 2010 Elsevier España S.L. All rights reserved.

MapEdit: solution to continuous raster map creation

NASA Astrophysics Data System (ADS)

Rančić, Dejan; Djordjevi-Kajan, Slobodanka

2003-03-01

The paper describes MapEdit, MS Windows TM software for georeferencing and rectification of scanned paper maps. The software produces continuous raster maps which can be used as background in geographical information systems. Process of continuous raster map creation using MapEdit "mosaicking" function is also described as well as the georeferencing and rectification algorithms which are used in MapEdit. Our approach for georeferencing and rectification using four control points and two linear transformations for each scanned map part, together with nearest neighbor resampling method, represents low cost—high speed solution that produce continuous raster maps with satisfactory quality for many purposes (±1 pixel). Quality assessment of several continuous raster maps at different scales that have been created using our software and methodology, has been undertaken and results are presented in the paper. For the quality control of the produced raster maps we referred to three wide adopted standards: US Standard for Digital Cartographic Data, National Standard for Spatial Data Accuracy and US National Map Accuracy Standard. The results obtained during the quality assessment process are given in the paper and show that our maps meat all three standards.

The derivation of water quality criteria of copper in Biliu River

NASA Astrophysics Data System (ADS)

Zheng, Hongbo; Jia, Xinru

2018-03-01

Excessive copper in water can be detrimental to the health of human and aquatic life. China has promulgated Environmental Quality Standards for Surface Water to control water pollution, but uniform standard values may cause under-protection or over-protection. Therefore, the basic research work on water quality criteria of water source or reservoir is urgently needed. This study deduces the acute and chronic Water Quality Criteria (WQC) of copper in Biliu River by Species Sensitivity Distribution method (SSD). The result shows that BiDoseResp is the most suitable model and the acute and chronic water quality benchmark of copper are 10.72 µg•L-1 and 5.86 µg•L-1. This study provides basis for the construction of water quality standard of Liaoning and the environmental management of Biliu River.

VQone MATLAB toolbox: A graphical experiment builder for image and video quality evaluations: VQone MATLAB toolbox.

PubMed

Nuutinen, Mikko; Virtanen, Toni; Rummukainen, Olli; Häkkinen, Jukka

2016-03-01

This article presents VQone, a graphical experiment builder, written as a MATLAB toolbox, developed for image and video quality ratings. VQone contains the main elements needed for the subjective image and video quality rating process. This includes building and conducting experiments and data analysis. All functions can be controlled through graphical user interfaces. The experiment builder includes many standardized image and video quality rating methods. Moreover, it enables the creation of new methods or modified versions from standard methods. VQone is distributed free of charge under the terms of the GNU general public license and allows code modifications to be made so that the program's functions can be adjusted according to a user's requirements. VQone is available for download from the project page (http://www.helsinki.fi/psychology/groups/visualcognition/).

Method and platform standardization in MRM-based quantitative plasma proteomics.

PubMed

Percy, Andrew J; Chambers, Andrew G; Yang, Juncong; Jackson, Angela M; Domanski, Dominik; Burkhart, Julia; Sickmann, Albert; Borchers, Christoph H

2013-12-16

There exists a growing demand in the proteomics community to standardize experimental methods and liquid chromatography-mass spectrometry (LC/MS) platforms in order to enable the acquisition of more precise and accurate quantitative data. This necessity is heightened by the evolving trend of verifying and validating candidate disease biomarkers in complex biofluids, such as blood plasma, through targeted multiple reaction monitoring (MRM)-based approaches with stable isotope-labeled standards (SIS). Considering the lack of performance standards for quantitative plasma proteomics, we previously developed two reference kits to evaluate the MRM with SIS peptide approach using undepleted and non-enriched human plasma. The first kit tests the effectiveness of the LC/MRM-MS platform (kit #1), while the second evaluates the performance of an entire analytical workflow (kit #2). Here, these kits have been refined for practical use and then evaluated through intra- and inter-laboratory testing on 6 common LC/MS platforms. For an identical panel of 22 plasma proteins, similar concentrations were determined, regardless of the kit, instrument platform, and laboratory of analysis. These results demonstrate the value of the kit and reinforce the utility of standardized methods and protocols. The proteomics community needs standardized experimental protocols and quality control methods in order to improve the reproducibility of MS-based quantitative data. This need is heightened by the evolving trend for MRM-based validation of proposed disease biomarkers in complex biofluids such as blood plasma. We have developed two kits to assist in the inter- and intra-laboratory quality control of MRM experiments: the first kit tests the effectiveness of the LC/MRM-MS platform (kit #1), while the second evaluates the performance of an entire analytical workflow (kit #2). In this paper, we report the use of these kits in intra- and inter-laboratory testing on 6 common LC/MS platforms. This article is part of a Special Issue entitled: Standardization and Quality Control in Proteomics. © 2013.

Real Time Quality Control Methods for Cued EMI Data Collection

DTIC Science & Technology

2016-03-14

contents be construed as reflecting the official policy or position of the Department of Defense. Reference herein to any specific commercial product...This project evaluated the effectiveness of in-field quality control (QC) procedures during cued electromagnetic induction (EMI) data collection. The...electromagnetic induction ESTCP Environmental Security Technology Certification Program hr hour ISO Industry Standard Object IVS Instrument

Simultaneous determination of six active components by a single standard to determine multicomponents combined with fingerprint analysis for the quality control of Rhizoma Chuanxiong.

PubMed

He, Yufei; Li, Qing; Bi, Kaishun

2015-04-01

To control the quality of Rhizoma Chuanxiong, a method based on high-performance liquid chromatography method coupled with diode array detection was developed for the quantitative analysis of six active ingredients using a single standard to determine multi-components and chemical fingerprint analysis for the first time. The separation was performed on an Agilent Zorbax SB-C18 column by gradient elution with methanol and aqueous phase (containing 0.5% glacial acetic acid) at a flow rate of 1.0 mL/min. The UV wavelength was set at 274 nm. This assay was fully validated with respect to precision, repeatability, and accuracy. All calibration curves showed good linearity (R(2) > 0.9994) within test ranges. The limit of detection and limit of quantification were lower than 0.01 and 0.03 μg/mL, respectively. The relative standard deviation for repeatability and the intermediate precision of six analytes were less than 1.6 and 2.5%, respectively, the overall recovery was 96.1-103.1%. In addition, fingerprint chromatography using hierarchical clustering analysis and similarity analysis was performed to differentiate and classify the samples. The method described here could provide a more comprehensive and reasonable scientific assessment of the quality of Rhizoma Chuanxiong. Therefore, the strategy is feasible, credible, and is easily and effectively adapted for evaluating the quality control of Rhizoma Chuanxiong. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Standard Free Droplet Digital Polymerase Chain Reaction as a New Tool for the Quality Control of High-Capacity Adenoviral Vectors in Small-Scale Preparations

PubMed Central

Boehme, Philip; Stellberger, Thorsten; Solanki, Manish; Zhang, Wenli; Schulz, Eric; Bergmann, Thorsten; Liu, Jing; Doerner, Johannes; Baiker, Armin E.

2015-01-01

Abstract High-capacity adenoviral vectors (HCAdVs) are promising tools for gene therapy as well as for genetic engineering. However, one limitation of the HCAdV vector system is the complex, time-consuming, and labor-intensive production process and the following quality control procedure. Since HCAdVs are deleted for all viral coding sequences, a helper virus (HV) is needed in the production process to provide the sequences for all viral proteins in trans. For the purification procedure of HCAdV, cesium chloride density gradient centrifugation is usually performed followed by buffer exchange using dialysis or comparable methods. However, performing these steps is technically difficult, potentially error-prone, and not scalable. Here, we establish a new protocol for small-scale production of HCAdV based on commercially available adenovirus purification systems and a standard method for the quality control of final HCAdV preparations. For titration of final vector preparations, we established a droplet digital polymerase chain reaction (ddPCR) that uses a standard free-end-point PCR in small droplets of defined volume. By using different probes, this method is capable of detecting and quantifying HCAdV and HV in one reaction independent of reference material, rendering this method attractive for accurately comparing viral titers between different laboratories. In summary, we demonstrate that it is possible to produce HCAdV in a small scale of sufficient quality and quantity to perform experiments in cell culture, and we established a reliable protocol for vector titration based on ddPCR. Our method significantly reduces time and required equipment to perform HCAdV production. In the future the ddPCR technology could be advantageous for titration of other viral vectors commonly used in gene therapy. PMID:25640117

Design and Establishment of Quality Model of Fundamental Geographic Information Database

NASA Astrophysics Data System (ADS)

Ma, W.; Zhang, J.; Zhao, Y.; Zhang, P.; Dang, Y.; Zhao, T.

2018-04-01

In order to make the quality evaluation for the Fundamental Geographic Information Databases(FGIDB) more comprehensive, objective and accurate, this paper studies and establishes a quality model of FGIDB, which formed by the standardization of database construction and quality control, the conformity of data set quality and the functionality of database management system, and also designs the overall principles, contents and methods of the quality evaluation for FGIDB, providing the basis and reference for carry out quality control and quality evaluation for FGIDB. This paper designs the quality elements, evaluation items and properties of the Fundamental Geographic Information Database gradually based on the quality model framework. Connected organically, these quality elements and evaluation items constitute the quality model of the Fundamental Geographic Information Database. This model is the foundation for the quality demand stipulation and quality evaluation of the Fundamental Geographic Information Database, and is of great significance on the quality assurance in the design and development stage, the demand formulation in the testing evaluation stage, and the standard system construction for quality evaluation technology of the Fundamental Geographic Information Database.

[Report quality of randomized controlled trials of moxibustion for knee osteoarthritis based on CONSORT and STRICTOM].

PubMed

Xiong, Jun; Zhu, Daocheng; Chen, Rixin; Ye, Wenguo

2015-08-01

The report quality of randomized controlled trials (RCTs) of moxibustion for knee osteoarthritis (KOA) in China was evaluated by Consolidated Standards for Reporting of Trials (CONSORT) and Standards for Reporting Interventions in Controlled Trials of Moxibustion (STRICTOM). Computer and manual retrieval was used. Four databases of China National Knowledge Infrastructure (CNKD, China Biomedicine (CBM), VIP and WNFANG were searched in combination with manual retrieval for relevant journals to screen the literature that: met the inclusive criteria, and CONSORT and STRICTOM were used to assess the report quality. A total of 52 RCTs were included. It was found that unclear description of random methods, low use of blind methods, no allocation concealment, no sample size calculation, no intention-to-treat analysis,inadequate report of moxibustion details and no mention of practitioners background existed in the majority of the RCTs. Although the quality of RCTs of moxibustion for KOA was generally low, reducing the reliability and homogeneous comparability of the reports ,the quality of heat-sensitive moxibustion RCTs was high. It was believed that in order to improve the reliability and quality of RCTs of moxibustion, CONSORT and STRICTOM should be introduced into the RCT design of moxibustion and be strictly performed.

HPLC fingerprint analysis combined with chemometrics for pattern recognition of ginger.

PubMed

Feng, Xu; Kong, Weijun; Wei, Jianhe; Ou-Yang, Zhen; Yang, Meihua

2014-03-01

Ginger, the fresh rhizome of Zingiber officinale Rosc. (Zingiberaceae), has been used worldwide; however, for a long time, there has been no standard approbated internationally for its quality control. To establish an efficacious and combinational method and pattern recognition technique for quality control of ginger. A simple, accurate and reliable method based on high-performance liquid chromatography with photodiode array (HPLC-PDA) detection was developed for establishing the chemical fingerprints of 10 batches of ginger from different markets in China. The method was validated in terms of precision, reproducibility and stability; and the relative standard deviations were all less than 1.57%. On the basis of this method, the fingerprints of 10 batches of ginger samples were obtained, which showed 16 common peaks. Coupled with similarity evaluation software, the similarities between each fingerprint of the sample and the simulative mean chromatogram were in the range of 0.998-1.000. Then, the chemometric techniques, including similarity analysis, hierarchical clustering analysis and principal component analysis were applied to classify the ginger samples. Consistent results were obtained to show that ginger samples could be successfully classified into two groups. This study revealed that HPLC-PDA method was simple, sensitive and reliable for fingerprint analysis, and moreover, for pattern recognition and quality control of ginger.

[Analysis of the results of the HIV-1, HCV and HBV viral load of SEIMC External Quality Control Program. Year 2014].

PubMed

Medina González, Rafael; Orta Mira, Nieves; Guna Serrano, María Del Remedio; Latorre Martínez, José-Carlos; Gopegui, Enrique Ruiz de; Rosario Ovies, María; Poveda, Marta; Gimeno Cardona, Concepción

2016-07-01

Human immunodeficiency virus type 1 (HIV-1), hepatitis B virus (HBV) and hepatitis C virus (HCV) viral load determinations are among the most relevant markers for the follow up of patients infected with these viruses. External quality control tools are crucial to ensure the accuracy of results obtained by microbiology laboratories. This article summarizes the results obtained from the 2014 SEIMC (Spanish Society of Infectious Diseases and Clinical Microbiology) External Quality Control Programme for HIV-1, HCV, and HBV viral loads. In the HIV-1 program, a total of 5 standards were sent. One standard consisted in seronegative human plasma, while the remaining 4 contained plasma from 3 different viremic patients, in the range of 2-5 log10 copies/mL; 2 of these standards were identical aiming to determine repeatability. A significant proportion of the laboratories (30.8% on average) obtained values out of the accepted range (mean ± 0.25 log10 copies/mL), depending on the standard and on the method used for quantification. Repeatability was excellent, with up to 95.8% of laboratories reporting results within the limits (Δ < 0.5 log10 copies/mL). The HBV and HCV program consisted of 2 standards with different viral load contents. Most of the participants, 83.7% in the case of HCV and 87.9% in the HBV, obtained all the results within the accepted range (mean ± 1.96 standard deviations log10 IU/mL). Data from this analysis reinforce the utility of proficiency programmes to ensure the quality of the results obtained by a particular laboratory, as well as the importance of the post-analytical phase on the overall quality. Due to the remarkable interlaboratory variability, it is advisable to use the same method and the same laboratory for patient follow up. Copyright © 2016 Elsevier España, S.L.U. All rights reserved.

Do Clinical Standards for Diabetes Care Address Excess Risk for Hypoglycemia in Vulnerable Patients? A Systematic Review

PubMed Central

Berkowitz, Seth A; Aragon, Katherine; Hines, Jonas; Seligman, Hilary; Lee, Sei; Sarkar, Urmimala

2013-01-01

Objective To determine whether diabetes clinical standards consider increased hypoglycemia risk in vulnerable patients. Data Sources MEDLINE, the National Guidelines Clearinghouse, the National Quality Measures Clearinghouse, and supplemental sources. Study Design Systematic review of clinical standards (guidelines, quality metrics, or pay-for-performance programs) for glycemic control in adult diabetes patients. The primary outcome was discussion of increased risk for hypoglycemia in vulnerable populations. Data Collection/Extraction Methods Manuscripts identified were abstracted by two independent reviewers using prespecified inclusion/exclusion criteria and a standardized abstraction form. Principal Findings We screened 1,166 titles, and reviewed 220 manuscripts in full text. Forty-four guidelines, 17 quality metrics, and 8 pay-for-performance programs were included. Five (11 percent) guidelines and no quality metrics or pay-for-performance programs met the primary outcome. Conclusions Clinical standards do not substantively incorporate evidence about increased risk for hypoglycemia in vulnerable populations. PMID:23445498

Multicenter Cell Processing for Cardiovascular Regenerative Medicine Applications - The Cardiovascular Cell Therapy Research Network (CCTRN) Experience

PubMed Central

Gee, Adrian P.; Richman, Sara; Durett, April; McKenna, David; Traverse, Jay; Henry, Timothy; Fisk, Diann; Pepine, Carl; Bloom, Jeannette; Willerson, James; Prater, Karen; Zhao, David; Koç, Jane Reese; Ellis, Steven; Taylor, Doris; Cogle, Christopher; Moyé, Lemuel; Simari, Robert; Skarlatos, Sonia

2013-01-01

Background Aims Multi-center cellular therapy clinical trials require the establishment and implementation of standardized cell processing protocols and associated quality control mechanisms. The aims here were to develop such an infrastructure in support of the Cardiovascular Cell Therapy Research Network (CCTRN) and to report on the results of processing for the first 60 patients. Methods Standardized cell preparations, consisting of autologous bone marrow mononuclear cells, prepared using the Sepax device were manufactured at each of the five processing facilities that supported the clinical treatment centers. Processing staff underwent centralized training that included proficiency evaluation. Quality was subsequently monitored by a central quality control program that included product evaluation by the CCTRN biorepositories. Results Data from the first 60 procedures demonstrate that uniform products, that met all release criteria, could be manufactured at all five sites within 7 hours of receipt of the bone marrow. Uniformity was facilitated by use of the automated systems (the Sepax for processing and the Endosafe device for endotoxin testing), standardized procedures and centralized quality control. Conclusions Complex multicenter cell therapy and regenerative medicine protocols can, where necessary, successfully utilize local processing facilities once an effective infrastructure is in place to provide training, and quality control. PMID:20524773

Quality Space and Launch Requirements, Addendum to AS9100C

DTIC Science & Technology

2015-05-08

45 8.9.1 Statistical Process Control (SPC) .......................................................................... 45...SMC Space and Missile Systems Center SME Subject Matter Expert SOW Statement of Work SPC Statistical Process Control SPO System Program Office SRP...occur without any individual data exceeding the control limits. Control limits are developed using standard statistical methods or other approved

Assessing the influence of component processing and donor characteristics on quality of red cell concentrates using quality control data.

PubMed

Jordan, A; Chen, D; Yi, Q-L; Kanias, T; Gladwin, M T; Acker, J P

2016-07-01

Quality control (QC) data collected by blood services are used to monitor production and to ensure compliance with regulatory standards. We demonstrate how analysis of quality control data can be used to highlight the sources of variability within red cell concentrates (RCCs). We merged Canadian Blood Services QC data with manufacturing and donor records for 28 227 RCC between June 2011 and October 2014. Units were categorized based on processing method, bag manufacturer, donor age and donor sex, then assessed based on product characteristics: haemolysis and haemoglobin levels, unit volume, leucocyte count and haematocrit. Buffy-coat method (top/bottom)-processed units exhibited lower haemolysis than units processed using the whole-blood filtration method (top/top). Units from female donors exhibited lower haemolysis than male donations. Processing method influenced unit volume and the ratio of additive solution to residual plasma. Stored red blood cell characteristics are influenced by prestorage processing and donor factors. Understanding the relationship between processing, donors and RCC quality will help blood services to ensure the safety of transfused products. © 2016 International Society of Blood Transfusion.

30 CFR 250.302 - Definitions concerning air quality.

Code of Federal Regulations, 2011 CFR

2011-07-01

... and 250.304 of this part: Air pollutant means any combination of agents for which the Environmental... shown by monitored data or which is calculated by air quality modeling (or other methods determined by... standards established by EPA. Best available control technology (BACT) means an emission limitation based on...

Collaborative study on saccharide quantification of the Haemophilus influenzae type b component in liquid vaccine presentations.

PubMed

Rosskopf, U; Daas, A; Terao, E; von Hunolstein, C

2017-01-01

Before release onto the market, it must be demonstrated that the total and free polysaccharide (poly ribosyl-ribitol-phosphate, PRP) content of Haemophilus influenzae type b (Hib) vaccine complies with requirements. However, manufacturers use different methods to assay PRP content: a national control laboratory must establish and validate the relevant manufacturer methodology before using it to determine PRP content. An international study was organised by the World Health Organization (WHO), in collaboration with the Biological Standardisation Programme (BSP) of the Council of Europe/European Directorate for the Quality of Medicines & HealthCare (EDQM) and of the European Union Commission, to verify the suitability of a single method for determining PRP content in liquid pentavalent vaccines (DTwP-HepB-Hib) containing a whole-cell pertussis component. It consists of HCl hydrolysis followed by chromatographic separation and quantification of ribitol on a CarboPac MA1 column using high-performance anion exchange chromatography coupled with pulsed amperometric detection (HPAEC-PAD). The unconjugated, free, PRP is separated from the total PRP using C4 solid-phase extraction cartridges (SPE C4). Ten quality control laboratories performed two independent analyses applying the proposed analytical test protocol to five vaccine samples, including a vaccine lot with sub-potent PRP content and very high free PRP content. Both WHO PRP standard and ribitol reference standard were included as calibrating standards. A significant bias between WHO PRP standard and ribitol reference standard was observed. Study results showed that the proposed analytical method is, in principle, suitable for the intended use provided that a validation is performed as usually expected from quality control laboratories.

How standard is standard care? Exploring control group outcomes in behaviour change interventions for young people with type 1 diabetes.

PubMed

Ayling, K; Brierley, S; Johnson, B; Heller, S; Eiser, C

2015-01-01

Poor descriptions of standard care may compromise interpretation of results in randomised controlled trials (RCTs) of health interventions. We investigated quality of standard care in RCTs of behaviour change interventions for young people with type 1 diabetes and consider implications for evaluating trial outcomes. We conducted systematic searches for articles published between 1999 and 2012. We extracted standard care descriptions and contacted trial authors to complete a checklist of standard care activities. The relationship between standard care quality and outcomes was examined via subgroup meta-analyses and meta-regression. Standard care descriptions, standard care quality, and relationships between standard care quality with medical and psychological outcomes. We identified 20 RCTs described across 26 articles. Published descriptions of standard care were limited to service-level features. Author responses indicated standard care provision extended beyond published accounts. Subgroup analyses suggested control groups receiving higher standard care quality showed larger improvements in both medical and psychological outcomes, although standard care quality did not predict outcomes significantly. The quality of care delivered to control group participants can influence outcomes of RCTs. Inadequate reporting exacerbates this issue by masking variations between trials. We argue for increased clarity in reporting standard care in future trials.

Chemical investigation of commercial grape seed derived products to assess quality and detect adulteration.

PubMed

Villani, Tom S; Reichert, William; Ferruzzi, Mario G; Pasinetti, Giulio M; Simon, James E; Wu, Qingli

2015-03-01

Fundamental concerns in quality control arise due to increasing use of grape seed extract (GSE) and the complex chemical composition of GSE. Proanthocyanidin monomers and oligomers are the major bioactive compounds in GSE. Given no standardized criteria for quality, large variation exists in the composition of commercial GSE supplements. Using HPLC/UV/MS, 21 commercial GSE containing products were purchased and chemically profiled, major compounds quantitated, and compared against authenticated grape seed extract, peanut skin extract, and pine bark extract. The antioxidant capacity and total polyphenol content for each sample was also determined and compared using standard techniques. Nine products were adulterated, found to contain peanut skin extract. A wide degree of variability in chemical composition was detected in commercial products, demonstrating the need for development of quality control standards for GSE. A TLC method was developed to allow for rapid and inexpensive detection of adulteration in GSE by peanut skin. Copyright © 2014 Elsevier Ltd. All rights reserved.

Emerging developments in the standardized chemical characterization of indoor air quality.

PubMed

Nehr, Sascha; Hösen, Elisabeth; Tanabe, Shin-Ichi

2017-01-01

Despite the fact that the special characteristics of indoor air pollution make closed environments quite different from outdoor environments, the conceptual ideas for assessing air quality indoors and outdoors are similar. Therefore, the elaboration of International Standards for air quality characterization in view of controlling indoor air quality should resort to this common basis. In this short review we describe the possibilities of standardization of tools dedicated to indoor air quality characterization with a focus on the tools permitting to study the indoor air chemistry. The link between indoor exposure and health as well as the critical processes driving the indoor air quality are introduced. Available International Standards for the assessment of indoor air quality are depicted. The standards comprise requirements for the sampling on site, the analytical procedures, and the determination of material emissions. To date, these standardized procedures assure that indoor air, settled dust and material samples are analyzed in a comparable manner. However, existing International Standards exclusively specify conventional, event-driven target-screening using discontinuous measurement methods for long-lived pollutants. Therefore, this review draws a parallel between physico-chemical processes in indoor and outdoor environments. The achievements in atmospheric sciences also improve our understanding of indoor environments. The community of atmospheric scientists can be both ideal and supporter for researchers in the area of indoor air quality characterization. This short review concludes with propositions for future standardization activities for the chemical characterization of indoor air quality. Future standardization efforts should focus on: (i) the elaboration of standardized measurement methods and measurement strategies for online monitoring of long-lived and short-lived pollutants, (ii) the assessment of the potential and the limitations of non-target screening, (iii) the paradigm shift from event-driven investigations to systematic approaches to characterize indoor environments, and (iv) the development of tools for policy implementation. Copyright © 2016 Elsevier Ltd. All rights reserved.

[Quality control of Maca (Lepidium meyenii)].

PubMed

Shu, Ji-cheng; Cui, Hang-qing; Huang, Ying-zheng; Huang, Xiao-ying; Yang, Ming

2015-12-01

To control the quality of Maca, the quality standard was established in this study. According to the methods recorded in the Appendix of Chinese Pharmacopoeia (2010 Edition), the water, extract, total ash, acid insoluble substance, and heavy metals inspections in Lepidium meyenii were carried out. N-benzyl-9Z, 12Z-octadecadienamide in L. meyenii was identified by TLC, and it was determined by HPLC. The results showed that the N-benzyl-9Z, 12Z-octadecadienamide identification of TLC was a strong mark and specificity. In content determination experiment, the linearity of N-benzyl-9Z, 12Z-octadecadienamide was in the range of 0.01-2 microg (r = 0.9998), and the average recovery (n=9) was 99.27% (RSD 2.0%). The methods were simple, accurate, with good reproducibility. It is suitable for quality control L. meyenii.

A Strategy to Establish a Quality Assurance/Quality Control Plan for the Application of Biosensors for the Detection of E. coli in Water.

PubMed

Hesari, Nikou; Kıratlı Yılmazçoban, Nursel; Elzein, Mohamad; Alum, Absar; Abbaszadegan, Morteza

2017-01-03

Rapid bacterial detection using biosensors is a novel approach for microbiological testing applications. Validation of such methods is an obstacle in the adoption of new bio-sensing technologies for water testing. Therefore, establishing a quality assurance and quality control (QA/QC) plan is essential to demonstrate accuracy and reliability of the biosensor method for the detection of E. coli in drinking water samples. In this study, different reagents and assay conditions including temperatures, holding time, E. coli strains and concentrations, dissolving agents, salinity and pH effects, quality of substrates of various suppliers of 4-methylumbelliferyl glucuronide (MUG), and environmental water samples were included in the QA/QC plan and used in the assay optimization and documentation. Furthermore, the procedural QA/QC for the monitoring of drinking water samples was established to validate the performance of the biosensor platform for the detection of E. coli using a culture-based standard technique. Implementing the developed QA/QC plan, the same level of precision and accuracy was achieved using both the standard and the biosensor methods. The established procedural QA/QC for the biosensor will provide a reliable tool for a near real-time monitoring of E. coli in drinking water samples to both industry and regulatory authorities.

A Strategy to Establish a Quality Assurance/Quality Control Plan for the Application of Biosensors for the Detection of E. coli in Water

PubMed Central

Hesari, Nikou; Kıratlı Yılmazçoban, Nursel; Elzein, Mohamad; Alum, Absar; Abbaszadegan, Morteza

2017-01-01

Rapid bacterial detection using biosensors is a novel approach for microbiological testing applications. Validation of such methods is an obstacle in the adoption of new bio-sensing technologies for water testing. Therefore, establishing a quality assurance and quality control (QA/QC) plan is essential to demonstrate accuracy and reliability of the biosensor method for the detection of E. coli in drinking water samples. In this study, different reagents and assay conditions including temperatures, holding time, E. coli strains and concentrations, dissolving agents, salinity and pH effects, quality of substrates of various suppliers of 4-methylumbelliferyl glucuronide (MUG), and environmental water samples were included in the QA/QC plan and used in the assay optimization and documentation. Furthermore, the procedural QA/QC for the monitoring of drinking water samples was established to validate the performance of the biosensor platform for the detection of E. coli using a culture-based standard technique. Implementing the developed QA/QC plan, the same level of precision and accuracy was achieved using both the standard and the biosensor methods. The established procedural QA/QC for the biosensor will provide a reliable tool for a near real-time monitoring of E. coli in drinking water samples to both industry and regulatory authorities. PMID:28054956

Zinc thermal spray coatings for reinforced concrete: An AWS process standard

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

Sulit, R.A.

Zinc and aluminum thermal spray coatings (TSC) have been used for lining concrete weir in Great Britain since the 1950`s to maintain the dimensions of the weir for flow control concomitant with reduced wear and erosion of the concrete surfaces. This paper reports the development and the content of the ANSI/AWS C2.20-XX standard for the application of An TSC on concrete using flame and arc spray processes. This standard is formatted as an industrial process instruction: job description; safety; feedstock materials; equipment; a step-by-step method for surface preparation, thermal spraying; quality control; repair and maintenance of surface preparation, thermal spraying;more » quality control; repair and maintenance of Zn TSC on concrete; and a Job Control Record. Job planning and training and certification requirements are presented for An TSC inspectors and thermal spray operators. Four annexes are included in the standard: (a) historical summary of Zn TSC on concrete (b) sample job control record; (c) thermal spray operator qualification; and (d) portable adhesion testing for An TSC on concrete. This standard is based on the current literature and industrial equipment, process, and practices.« less

Development and implementation of an audit tool for quality control of parenteral nutrition.

PubMed

García-Rodicio, Sonsoles; Abajo, Celia; Godoy, Mercedes; Catalá, Miguel Angel

2009-01-01

The aim of this article is to describe the development of a quality control methodology applied to patients receiving parenteral nutrition (PN) and to present the results obtained over the past 10 years. Development of the audit tool: In 1995, a total of 13 PN quality criteria and their standards were defined based on literature and past experiences. They were applied during 5 different 6-month audits carried out in subsequent years. According to the results of each audit, the criteria with lower validity were eliminated, while others were optimized and new criteria were introduced to complete the monitoring of other areas not previously examined. Currently, the quality control process includes 22 quality criteria and their standards that examine the following 4 different areas: (1) indication and duration of PN; (2) nutrition assessment, adequacy of the nutrition support, and monitoring; (3) metabolic and infectious complications; and (4) global efficacy of the nutrition support regimen. The authors describe the current definition of each criterion and present the results obtained in the 5 audits performed. In the past year, 9 of the 22 criteria reached the predefined standards. The areas detected for further improvements were: indication for PN, nutrition assessment, and management of catheter infections. The definition of quality criteria and their standards is an efficient method of providing a qualitative and quantitative analysis of the clinical care of patients receiving PN. It detects areas for improvement and assists in developing a methodology to work efficiently.

[Analysis of the results of the HIV-1, HCV and HBV viral load of SEIMC External Quality Control Program. Year 2013].

PubMed

Orta Mira, Nieves; Del Remedio Guna Serrano, María; Latorre Martínez, José-Carlos; Medina González, Rafael; Rosario Ovies, María; Poveda, Marta; Ruiz de Gopegui, Enrique; Gimeno Cardona, Concepción

2015-07-01

Human immunodeficiency virus type 1 (HIV-1) and hepatitis B (HBV) and C virus (HCV) viral load determinations are among the most relevant markers for the follow up of patients infected with these viruses. External quality control tools are crucial to ensure the accuracy of results obtained by microbiology laboratories. This article summarized the results obtained from the 2013 SEIMC External Quality Control Programme for HIV-1, HCV, and HBV viral loads. In the HIV-1 program, a total of five standards were sent. One standard consisted in seronegative human plasma, while the remaining four contained plasma from three different viremic patients, in the range of 2-5 log10 copies/mL; two of these standards were identical aiming to determine repeatability. A significant proportion of the laboratories (25% on average) obtained values out of the accepted range (mean ± 0.25 log10 copies/mL), depending on the standard and on the method used for quantification. Repeatability was excellent, with up to 98.9% of laboratories reporting results within the limits (D < 0.5 log10 copies/mL). The HBV and HCV program consisted of two standards with different viral load contents. Most of the participants, 82% in the case of HCV and 78% in the HBV, obtained all the results within the accepted range (mean ± 1.96 SD log10 UI/mL). Data from this analysis reinforce the utility of proficiency programmes to ensure the quality of the results obtained by a particular laboratory, as well as the importance of the post-analytical phase on the overall quality. Due to the remarkable interlaboratory variability, it is advisable to use the same method and the same laboratory for patient follow up. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

Bootstrap Signal-to-Noise Confidence Intervals: An Objective Method for Subject Exclusion and Quality Control in ERP Studies

PubMed Central

Parks, Nathan A.; Gannon, Matthew A.; Long, Stephanie M.; Young, Madeleine E.

2016-01-01

Analysis of event-related potential (ERP) data includes several steps to ensure that ERPs meet an appropriate level of signal quality. One such step, subject exclusion, rejects subject data if ERP waveforms fail to meet an appropriate level of signal quality. Subject exclusion is an important quality control step in the ERP analysis pipeline as it ensures that statistical inference is based only upon those subjects exhibiting clear evoked brain responses. This critical quality control step is most often performed simply through visual inspection of subject-level ERPs by investigators. Such an approach is qualitative, subjective, and susceptible to investigator bias, as there are no standards as to what constitutes an ERP of sufficient signal quality. Here, we describe a standardized and objective method for quantifying waveform quality in individual subjects and establishing criteria for subject exclusion. The approach uses bootstrap resampling of ERP waveforms (from a pool of all available trials) to compute a signal-to-noise ratio confidence interval (SNR-CI) for individual subject waveforms. The lower bound of this SNR-CI (SNRLB) yields an effective and objective measure of signal quality as it ensures that ERP waveforms statistically exceed a desired signal-to-noise criterion. SNRLB provides a quantifiable metric of individual subject ERP quality and eliminates the need for subjective evaluation of waveform quality by the investigator. We detail the SNR-CI methodology, establish the efficacy of employing this approach with Monte Carlo simulations, and demonstrate its utility in practice when applied to ERP datasets. PMID:26903849

High cortisol levels are associated with low quality food choice in type 2 diabetes.

PubMed

Duong, Michelle; Cohen, Jessica I; Convit, Antonio

2012-02-01

Hypothalamic-pituitary-adrenal (HPA) axis control may be impaired in type 2 diabetes (T2DM). Glucocorticoids increase consumption of low quality foods high in calories, sugar, and fat. We explored the relationship between cortisol levels, poor blood glucose control, and food quality choice in T2DM. Twenty-seven healthy controls were age-, gender- and education-matched to 27 T2DM participants. Standard clinical blood tests and cortisol values were measured from fasting blood samples. Participants recorded all consumed food and drink items in a consecutive 3-day food diary. Diaries were analyzed for "high quality" and "low quality" foods using a standardized method with high reliability (0.97 and 0.86, respectively). Controlling for education, body mass index (BMI) and hemoglobin A1C (HbA1C), log-transformed cortisol (LogC) predicted the percent of low quality foods (R (2) = 0.092, β = 0.360, P < 0.05), but not the percent of high quality foods chosen. Controlling for education, BMI, and LogC, HbA1C significantly predicted both the percent of low quality foods (ΔR (2) = 0.079, β = 0.348, P = 0.024) and high quality foods chosen (ΔR (2) = 0.085, β = -0.362, P = 0.022). The relationship between HbA1C and low quality food choice may be mediated by cortisol, controlling for BMI and education (P < 0.01). HbA1C displayed both an indirect (cortisol-mediated) effect (P < 0.05) and direct effect on low quality food choice (P < 0.05). The relationship between HbA1C and low quality food choice may be partially mediated by cortisol. Poor blood glucose control may cause HPA axis disruption, increased consumption of low quality foods.

New patient-controlled abdominal compression method in radiography: radiation dose and image quality.

PubMed

Piippo-Huotari, Oili; Norrman, Eva; Anderzén-Carlsson, Agneta; Geijer, Håkan

2018-05-01

The radiation dose for patients can be reduced with many methods and one way is to use abdominal compression. In this study, the radiation dose and image quality for a new patient-controlled compression device were compared with conventional compression and compression in the prone position . To compare radiation dose and image quality of patient-controlled compression compared with conventional and prone compression in general radiography. An experimental design with quantitative approach. After obtaining the approval of the ethics committee, a consecutive sample of 48 patients was examined with the standard clinical urography protocol. The radiation doses were measured as dose-area product and analyzed with a paired t-test. The image quality was evaluated by visual grading analysis. Four radiologists evaluated each image individually by scoring nine criteria modified from the European quality criteria for diagnostic radiographic images. There was no significant difference in radiation dose or image quality between conventional and patient-controlled compression. Prone position resulted in both higher dose and inferior image quality. Patient-controlled compression gave similar dose levels as conventional compression and lower than prone compression. Image quality was similar with both patient-controlled and conventional compression and was judged to be better than in the prone position.

Verification and quality control of routine hematology analyzers.

PubMed

Vis, J Y; Huisman, A

2016-05-01

Verification of hematology analyzers (automated blood cell counters) is mandatory before new hematology analyzers may be used in routine clinical care. The verification process consists of several items which comprise among others: precision, accuracy, comparability, carryover, background and linearity throughout the expected range of results. Yet, which standard should be met or which verification limit be used is at the discretion of the laboratory specialist. This paper offers practical guidance on verification and quality control of automated hematology analyzers and provides an expert opinion on the performance standard that should be met by the contemporary generation of hematology analyzers. Therefore (i) the state-of-the-art performance of hematology analyzers for complete blood count parameters is summarized, (ii) considerations, challenges, and pitfalls concerning the development of a verification plan are discussed, (iii) guidance is given regarding the establishment of reference intervals, and (iv) different methods on quality control of hematology analyzers are reviewed. © 2016 John Wiley & Sons Ltd.

21 CFR 640.56 - Quality control test for potency.

Code of Federal Regulations, 2010 CFR

2010-04-01

... quality control test for potency may be performed by a clinical laboratory which meets the standards of... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Quality control test for potency. 640.56 Section...) BIOLOGICS ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Cryoprecipitate § 640.56 Quality control...

HBA1c: clinical and biological agreement for standardization of assay methods. Report by the experts of ALFEDIAM (Association de Langue Française pour lEtude du Diabète et des Maladies Métabolique) and SFBC (Société Française de Biologie Clinique).

PubMed

Gillery, P; Bordas-Fonfrède, M; Chapelle, J P; Drouin, P; Hue, G; Lévy-Marchal, C; Périer, C; Sélam, J L; Slama, G; Thivolet, C; Vialettes, B

1999-09-01

Glycohaemoglobin, and particularly haemoglobin A1c(HbA1c), assays have been used for many years to retrospectively evaluate the glycaemic control of diabetic patients. Cut-off values have been established for deciding treatment modifications. The techniques used in the laboratories however exhibit varying quality, and all of them are not yet standardized. The consequence is an under-utilization of this test, especially in non-hospital practice. In this context, working groups of Société Française de Biologie Clinique (SFBC), Association de Langue Française pour l'Etude du Diabète et des Maladies Métaboliques (ALFEDIAM) and Société Française d'Endocrinologie (SFE) have met together, in order to analyze the national status, and to propose practical recommendations for implementing a standardization process on the basis of international experiences. It is recommended to exclusively express results as HbA1c percentage, using methods standardized and certified by comparison to reference methods such as those using Diabetes Control and Complications Trial (DCCT) values. Simultaneously, contacts have been established with manufacturers, and the realisation of periodic quality control surveys was encouraged.

[Analysis of the results of the 2010 External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology for HIV-1, HCV, and HBV viral loads].

PubMed

Orta Mira, Nieves; Serrano, María del Remedio Guna; Martínez, José-Carlos Latorre; Ovies, María Rosario; Poveda, Marta; de Gopegui, Enrique Ruiz; Cardona, Concepción Gimeno

2011-12-01

Human immunodeficiency virus type 1 (HIV-1) and hepatitis B (HBV) and C virus (HCV) viral load determinations are among the most important markers for the follow-up of patients infected with these viruses. External quality control tools are crucial to ensure the accuracy of the results obtained by microbiology laboratories. This article summarized the results obtained in the 2010 External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology for HIV-1, HCV, and HBV viral loads and HCV genotyping. In the HIV-1 program, a total of five standards were sent. One standard consisted of seronegative human plasma, while the remaining four contained plasma from three different viremic patients, in the range of 3-5 log(10) copies/mL; two of these standards were identical, with the aim of determining repeatability. A significant proportion of the laboratories (22.6% on average) obtained values out of the accepted range (mean ± 0.2 log(10)copies/mL), depending on the standard and on the method used for quantification. Repeatability was very good, with up to 95% of laboratories reporting results within the limits (Δ<0.5 log(10)copies/mL). The HBV and HCV program consisted of two standards with different viral load contents. Most of the participants, 86.1% in the case of HCV and 87.1% in HBV, obtained all the results within the accepted range (mean ± 1.96 SD log(10)UI/mL). Post-analytical errors due to mistranscription of the results were detected in these controls. Data from this analysis reinforce the utility of proficiency programs to ensure the quality of the results obtained by a particular laboratory, as well as the importance of the post-analytical phase in overall quality. Due to interlaboratory variability, use of the same method and the same laboratory for patient follow-up is advisable. Copyright © 2011 Elsevier España S.L. All rights reserved.

Study of Material Used in Nanotechnology for the Recycling of Industrial Waste Water

NASA Astrophysics Data System (ADS)

Larbi, L.; Fertikh, N.; Toubal, A.

The objective of our study is to recycle the industrial waste water of a industrial Complex after treatment by the bioprocess MBR (membrane bioreactor). In order to apply this bioprocess, the water quality in question was first of all studied. To characterize this industrial waste water, a series of physicochemical analysis was carried out according to standardized directives and methods. Following-up the water quality to meet the regulatory requirements with rejection of this industrial waste water, a study was done thanks to the permanently monitoring of the following relevant parameters(P): the flow, the potential of hydrogen (pH), the total suspended solids(TSS), the turbidity (Turb), the chemical oxygen demand (COD),the biochemical oxygen demand (BOD), the Kjeldahl total nitrogen (KTN) and ammonia (NH4+), the total phosphorus (Ptot), the fluorine (F), the oils (O), the fats (F) and the phenols (Ph). According to collected information, it was established the sampling rates to which the quality control was done, the selected analytical methods were validated by the control charts and the analysis test number was determined by the Cochran test. The results of the quality control show that some rejected water contents are not in the Algerian standards, but, in our case, the objective is the preoccupation for a standard setting of these industrial water parameters so as to recycle it. The process adopted by MBR for waste water treatment is being studied, first in the development of the experimental characterizing of the reactor and the selected membrane.

ANALYTICAL METHODS NECESSARY TO IMPLEMENT RISK-BASED CRITERIA FOR CHEMICALS IN MUNICIPAL SLUDGE

EPA Science Inventory

The Ambient Water Quality Criteria that were promulgated by the U.S. Environmental Protection Agency in 1980 included water concentration levels which, for many pollutants, were so low as to be unmeasurable by standard analytical methods. Criteria for controlling toxics in munici...

A proteomics performance standard to support measurement quality in proteomics.

PubMed

Beasley-Green, Ashley; Bunk, David; Rudnick, Paul; Kilpatrick, Lisa; Phinney, Karen

2012-04-01

The emergence of MS-based proteomic platforms as a prominent technology utilized in biochemical and biomedical research has increased the need for high-quality MS measurements. To address this need, National Institute of Standards and Technology (NIST) reference material (RM) 8323 yeast protein extract is introduced as a proteomics quality control material for benchmarking the preanalytical and analytical performance of proteomics-based experimental workflows. RM 8323 yeast protein extract is based upon the well-characterized eukaryote Saccharomyces cerevisiae and can be utilized in the design and optimization of proteomics-based methodologies from sample preparation to data analysis. To demonstrate its utility as a proteomics quality control material, we coupled LC-MS/MS measurements of RM 8323 with the NIST MS Quality Control (MSQC) performance metrics to quantitatively assess the LC-MS/MS instrumentation parameters that influence measurement accuracy, repeatability, and reproducibility. Due to the complexity of the yeast proteome, we also demonstrate how NIST RM 8323, along with the NIST MSQC performance metrics, can be used in the evaluation and optimization of proteomics-based sample preparation methods. © 2012 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

From quality markers to data mining and intelligence assessment: A smart quality-evaluation strategy for traditional Chinese medicine based on quality markers.

PubMed

Bai, Gang; Zhang, Tiejun; Hou, Yuanyuan; Ding, Guoyu; Jiang, Min; Luo, Guoan

2018-05-15

The quality of traditional Chinese medicine (TCM) forms the foundation of its clinical efficacy. The standardization of TCM is the most important task of TCM modernization. In recent years, there has been great progress in the quality control of TCM. However, there are still many issues related to the current quality standards, and it is difficult to objectively evaluate and effectively control the quality of TCM. To face these challenge, we summarized the current quality marker (Q-marker) research based on its characteristics and benefits, and proposed a reasonable and intelligentized quality evaluation strategy for the development and application of Q-markers. Ultra-performance liquid chromatography-quadrupole/time-of-flight with partial least squares-discriminant analysis was suggested to screen the chemical markers from Chinese medicinal materials (CMM), and a bioactive-guided evaluation method was used to select the Q-markers. Near-infrared spectroscopy (NIRS), based on the distinctive wavenumber zones or points from the Q-markers, was developed for its determination. Then, artificial intelligence algorithms were used to clarify the complex relationship between the Q-markers and their integral functions. Internet and mobile communication technology helped us to perform remote analysis and determine the information feedback of test samples. The quality control research, evaluation, standard establishment and quality control of TCM must be based on the systematic analysis of Q-markers to study and describe the material basis of TCM efficacy, define the chemical markers in the plant body, and understand the process of herb drug acquisition, change and transmission laws affecting metabolism and exposure. Based on the advantages of chemometrics, new sensor technologies, including infrared spectroscopy, hyperspectral imaging, chemical imaging, electronic nose and electronic tongue, have become increasingly important in the quality evaluation of CMM. Inspired by the concept of Q-marker, the quantitation can be achieved with the help of artificial intelligence, and these subtle differences can be discovered, allowing the quantitative analysis by NIRS and providing a quick and easy detection method for CMM quality evaluations. The concept of Q-markers focused on unique CMM differences, dynamic changes and their transmission and traceability to establish an overall quality control and traceability system. Based on the basic attributes, an integration model and artificial intelligence research path was proposed, with the hope of providing new ideas and perspectives for the TCM quality management. Copyright © 2018 Elsevier GmbH. All rights reserved.

Water Quality Assessment for Deep-water Channel area of Guangzhou Port based on the Comprehensive Water Quality Identification Index Method

NASA Astrophysics Data System (ADS)

Chen, Yi

2018-03-01

The comprehensive water quality identification index method is able to assess the general water quality situation comprehensively and represent the water quality classification; water environment functional zone achieves pollution level and standard objectively and systematically. This paper selects 3 representative zones along deep-water channel of Guangzhou port and applies comprehensive water quality identification index method to calculate sea water quality monitoring data for different selected zones from year 2006 to 2014, in order to investigate the temporal variation of water quality along deep-water channel of Guangzhou port. The comprehensive water quality level from north to south presents an increased trend, and the water quality of the three zones in 2014 is much better than in 2006. This paper puts forward environmental protection measurements and suggestions for Pearl River Estuary, provides data support and theoretical basis for studied sea area pollution prevention and control.

[Discussion on research thinking of traditional Chinese medicine standardization system based on whole process quality control].

PubMed

Dong, Ling; Sun, Yu; Pei, Wen-Xuan; Dai, Jun-Dong; Wang, Zi-Yu; Pan, Meng; Chen, Jiang-Peng; Wang, Yun

2017-12-01

The concept of "Quality by design" indicates that good design for the whole life cycle of pharmaceutical production enables the drug to meet the expected quality requirements. Aiming at the existing problems of the traditional Chinese medicine (TCM) industry, the TCM standardization system was put forward in this paper from the national strategic level, under the guidance by the idea of quality control in international manufacturing industry and with considerations of TCM industry's own characteristics and development status. The connotation of this strategy was to establish five interrelated systems: multi-indicators system based on tri-indicators system, quality standard and specification system of TCM herbal materials and decoction pieces, quality traceability system, data monitoring system based on whole-process quality control, and whole-process quality management system of TCM, and achieve the whole process systematic and scientific study in TCM industry through "top-level design-implement in steps-system integration" workflow. This article analyzed the correlation between the quality standards of all links, established standard operating procedures of each link and whole process, and constructed a high standard overall quality management system for TCM industry chains, in order to provide a demonstration for the establishment of TCM whole-process quality control system and provide systematic reference and basis for standardization strategy in TCM industry. Copyright© by the Chinese Pharmaceutical Association.

46 CFR 160.060-7 - Inspections and tests-standard and nonstandard vests. 1

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 6 2010-10-01 2010-10-01 false Inspections and tests-standard and nonstandard vests. 1... and nonstandard vests. 1 1 The manufacturer of a personal flotation device must meet 33 CFR 181.701... shall— (1) Maintain quality control of the materials used, the manufacturing methods, and the finished...

46 CFR 160.060-7 - Inspections and tests-standard and nonstandard vests. 1

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 6 2011-10-01 2011-10-01 false Inspections and tests-standard and nonstandard vests. 1... and nonstandard vests. 1 1 The manufacturer of a personal flotation device must meet 33 CFR 181.701... shall— (1) Maintain quality control of the materials used, the manufacturing methods, and the finished...

46 CFR 160.052-7 - Inspections and tests-standard and nonstandard vests. 1

Code of Federal Regulations, 2014 CFR

2014-10-01

... Buoyant Vest, Unicellular Plastic Foam, Adult and Child § 160.052-7 Inspections and tests—standard and...) Maintain quality control of the materials used, the manufacturing methods and workmanship, and the finished... scale in such a manner that the basket can be weighed while it is completely under water. In order to...

46 CFR 160.052-7 - Inspections and tests-standard and nonstandard vests. 1

Code of Federal Regulations, 2012 CFR

2012-10-01

... Buoyant Vest, Unicellular Plastic Foam, Adult and Child § 160.052-7 Inspections and tests—standard and...) Maintain quality control of the materials used, the manufacturing methods and workmanship, and the finished... scale in such a manner that the basket can be weighed while it is completely under water. In order to...

46 CFR 160.052-7 - Inspections and tests-standard and nonstandard vests. 1

Code of Federal Regulations, 2013 CFR

2013-10-01

... Buoyant Vest, Unicellular Plastic Foam, Adult and Child § 160.052-7 Inspections and tests—standard and...) Maintain quality control of the materials used, the manufacturing methods and workmanship, and the finished... scale in such a manner that the basket can be weighed while it is completely under water. In order to...

An integrated bioanalytical method development and validation approach: case studies.

PubMed

Xue, Y-J; Melo, Brian; Vallejo, Martha; Zhao, Yuwen; Tang, Lina; Chen, Yuan-Shek; Keller, Karin M

2012-10-01

We proposed an integrated bioanalytical method development and validation approach: (1) method screening based on analyte's physicochemical properties and metabolism information to determine the most appropriate extraction/analysis conditions; (2) preliminary stability evaluation using both quality control and incurred samples to establish sample collection, storage and processing conditions; (3) mock validation to examine method accuracy and precision and incurred sample reproducibility; and (4) method validation to confirm the results obtained during method development. This integrated approach was applied to the determination of compound I in rat plasma and compound II in rat and dog plasma. The effectiveness of the approach was demonstrated by the superior quality of three method validations: (1) a zero run failure rate; (2) >93% of quality control results within 10% of nominal values; and (3) 99% incurred sample within 9.2% of the original values. In addition, rat and dog plasma methods for compound II were successfully applied to analyze more than 900 plasma samples obtained from Investigational New Drug (IND) toxicology studies in rats and dogs with near perfect results: (1) a zero run failure rate; (2) excellent accuracy and precision for standards and quality controls; and (3) 98% incurred samples within 15% of the original values. Copyright © 2011 John Wiley & Sons, Ltd.

Evaluating Statistical Process Control (SPC) techniques and computing the uncertainty of force calibrations

NASA Technical Reports Server (NTRS)

Navard, Sharon E.

1989-01-01

In recent years there has been a push within NASA to use statistical techniques to improve the quality of production. Two areas where statistics are used are in establishing product and process quality control of flight hardware and in evaluating the uncertainty of calibration of instruments. The Flight Systems Quality Engineering branch is responsible for developing and assuring the quality of all flight hardware; the statistical process control methods employed are reviewed and evaluated. The Measurement Standards and Calibration Laboratory performs the calibration of all instruments used on-site at JSC as well as those used by all off-site contractors. These calibrations must be performed in such a way as to be traceable to national standards maintained by the National Institute of Standards and Technology, and they must meet a four-to-one ratio of the instrument specifications to calibrating standard uncertainty. In some instances this ratio is not met, and in these cases it is desirable to compute the exact uncertainty of the calibration and determine ways of reducing it. A particular example where this problem is encountered is with a machine which does automatic calibrations of force. The process of force calibration using the United Force Machine is described in detail. The sources of error are identified and quantified when possible. Suggestions for improvement are made.

Empirical evaluation of humpback whale telomere length estimates; quality control and factors causing variability in the singleplex and multiplex qPCR methods.

PubMed

Olsen, Morten Tange; Bérubé, Martine; Robbins, Jooke; Palsbøll, Per J

2012-09-06

Telomeres, the protective cap of chromosomes, have emerged as powerful markers of biological age and life history in model and non-model species. The qPCR method for telomere length estimation is one of the most common methods for telomere length estimation, but has received recent critique for being too error-prone and yielding unreliable results. This critique coincides with an increasing awareness of the potentials and limitations of the qPCR technique in general and the proposal of a general set of guidelines (MIQE) for standardization of experimental, analytical, and reporting steps of qPCR. In order to evaluate the utility of the qPCR method for telomere length estimation in non-model species, we carried out four different qPCR assays directed at humpback whale telomeres, and subsequently performed a rigorous quality control to evaluate the performance of each assay. Performance differed substantially among assays and only one assay was found useful for telomere length estimation in humpback whales. The most notable factors causing these inter-assay differences were primer design and choice of using singleplex or multiplex assays. Inferred amplification efficiencies differed by up to 40% depending on assay and quantification method, however this variation only affected telomere length estimates in the worst performing assays. Our results suggest that seemingly well performing qPCR assays may contain biases that will only be detected by extensive quality control. Moreover, we show that the qPCR method for telomere length estimation can be highly precise and accurate, and thus suitable for telomere measurement in non-model species, if effort is devoted to optimization at all experimental and analytical steps. We conclude by highlighting a set of quality controls which may serve for further standardization of the qPCR method for telomere length estimation, and discuss some of the factors that may cause variation in qPCR experiments.

Empirical evaluation of humpback whale telomere length estimates; quality control and factors causing variability in the singleplex and multiplex qPCR methods

PubMed Central

2012-01-01

Background Telomeres, the protective cap of chromosomes, have emerged as powerful markers of biological age and life history in model and non-model species. The qPCR method for telomere length estimation is one of the most common methods for telomere length estimation, but has received recent critique for being too error-prone and yielding unreliable results. This critique coincides with an increasing awareness of the potentials and limitations of the qPCR technique in general and the proposal of a general set of guidelines (MIQE) for standardization of experimental, analytical, and reporting steps of qPCR. In order to evaluate the utility of the qPCR method for telomere length estimation in non-model species, we carried out four different qPCR assays directed at humpback whale telomeres, and subsequently performed a rigorous quality control to evaluate the performance of each assay. Results Performance differed substantially among assays and only one assay was found useful for telomere length estimation in humpback whales. The most notable factors causing these inter-assay differences were primer design and choice of using singleplex or multiplex assays. Inferred amplification efficiencies differed by up to 40% depending on assay and quantification method, however this variation only affected telomere length estimates in the worst performing assays. Conclusion Our results suggest that seemingly well performing qPCR assays may contain biases that will only be detected by extensive quality control. Moreover, we show that the qPCR method for telomere length estimation can be highly precise and accurate, and thus suitable for telomere measurement in non-model species, if effort is devoted to optimization at all experimental and analytical steps. We conclude by highlighting a set of quality controls which may serve for further standardization of the qPCR method for telomere length estimation, and discuss some of the factors that may cause variation in qPCR experiments. PMID:22954451

Virtual reality exposure therapy for the treatment of anxiety disorders: an evaluation of research quality.

PubMed

McCann, Russell A; Armstrong, Christina M; Skopp, Nancy A; Edwards-Stewart, Amanda; Smolenski, Derek J; June, Jennifer D; Metzger-Abamukong, Melinda; Reger, Greg M

2014-08-01

Randomized controlled trials (RCTs) support the effectiveness of virtual reality exposure therapy (VRET) for anxiety disorders; however, the overall quality of the VRET RCT literature base has yet to be evaluated. This study reviewed 27 VRET RCTs and the degree of adherence to 8 RCT research design criteria derived from existing standards. Adherence to the study quality criteria was generally low as the articles met an average 2.85 criteria (SD=1.56). None of the studies met more than six quality criteria. Study quality did not predict effect size; however, a reduction in effect size magnitude was observed for studies with larger sample sizes when comparing VRET to non-active control groups. VRET may be an effective method of treatment but caution should be exercised in interpreting the existing body of literature supporting VRET relative to existing standards of care. The need for well-designed VRET research is discussed. Copyright © 2014. Published by Elsevier Ltd.

Quality assurance tendering and awarding contracts

NASA Astrophysics Data System (ADS)

1994-12-01

Standards relating to quality control can be significantly useful when tendering for and awarding contracts. However, because it is sometimes difficult to express these standards in palpable economic terms, they can (practically) never be applied as criteria for awarding contracts in accordance with U.A.R. (Uniform General Standards) 1986. Therefore it would be advisable in the future to regard the availability of a (certified) system of quality control as being a standard requirement. To this end, a paragraph setting requirements for a quality control plan should be included in the specification. A quality control plan will be required on awarding a contract. This envisaged scenario can best achieved through a transitional phase. During this period there will be opportunity enough for removing any shortcomings in the wording and for considering standards to be required and assessment procedures.

[Sampling methods for PM2.5 from stationary sources: a review].

PubMed

Jiang, Jing-Kun; Deng, Jian-Guo; Li, Zhen; Li, Xing-Hua; Duan, Lei; Hao, Ji-Ming

2014-05-01

The new China national ambient air quality standard has been published in 2012 and will be implemented in 2016. To meet the requirements in this new standard, monitoring and controlling PM2,,5 emission from stationary sources are very important. However, so far there is no national standard method on sampling PM2.5 from stationary sources. Different sampling methods for PM2.5 from stationary sources and relevant international standards were reviewed in this study. It includes the methods for PM2.5 sampling in flue gas and the methods for PM2.5 sampling after dilution. Both advantages and disadvantages of these sampling methods were discussed. For environmental management, the method for PM2.5 sampling in flue gas such as impactor and virtual impactor was suggested as a standard to determine filterable PM2.5. To evaluate environmental and health effects of PM2.5 from stationary sources, standard dilution method for sampling of total PM2.5 should be established.

Effect of paper quality on the response rate to a postal survey: A randomised controlled trial. [ISRCTN32032031

PubMed Central

Clark, T Justin; Khan, Khalid S; Gupta, Janesh K

2001-01-01

Background Response rates to surveys are declining and this threatens the validity and generalisability of their findings. We wanted to determine whether paper quality influences the response rate to postal surveys Methods A postal questionnaire was sent to all members of the British Society of Gynaecological Endoscopy (BSGE). Recipients were randomised to receiving the questionnaire printed on standard quality paper or high quality paper. Results The response rate for the recipients of high quality paper was 43/195 (22%) and 57/194 (29%) for standard quality paper (relative rate of response 0.75, 95% CI 0.33–1.05, p = 0.1 Conclusion The use of high quality paper did not increase response rates to a questionnaire survey of gynaecologists affiliated to an endoscopic society. PMID:11782286

[Methodological quality and reporting quality evaluation of randomized controlled trials published in China Journal of Chinese Materia Medica].

PubMed

Yu, Dan-Dan; Xie, Yan-Ming; Liao, Xing; Zhi, Ying-Jie; Jiang, Jun-Jie; Chen, Wei

2018-02-01

To evaluate the methodological quality and reporting quality of randomized controlled trials(RCTs) published in China Journal of Chinese Materia Medica, we searched CNKI and China Journal of Chinese Materia webpage to collect RCTs since the establishment of the magazine. The Cochrane risk of bias assessment tool was used to evaluate the methodological quality of RCTs. The CONSORT 2010 list was adopted as reporting quality evaluating tool. Finally, 184 RCTs were included and evaluated methodologically, of which 97 RCTs were evaluated with reporting quality. For the methodological evaluating, 62 trials(33.70%) reported the random sequence generation; 9(4.89%) trials reported the allocation concealment; 25(13.59%) trials adopted the method of blinding; 30(16.30%) trials reported the number of patients withdrawing, dropping out and those lost to follow-up;2 trials （1.09%） reported trial registration and none of the trial reported the trial protocol; only 8(4.35%) trials reported the sample size estimation in details. For reporting quality appraising, 3 reporting items of 25 items were evaluated with high-quality,including: abstract, participants qualified criteria, and statistical methods; 4 reporting items with medium-quality, including purpose, intervention, random sequence method, and data collection of sites and locations; 9 items with low-quality reporting items including title, backgrounds, random sequence types, allocation concealment, blindness, recruitment of subjects, baseline data, harms, and funding;the rest of items were of extremely low quality(the compliance rate of reporting item<10%). On the whole, the methodological and reporting quality of RCTs published in the magazine are generally low. Further improvement in both methodological and reporting quality for RCTs of traditional Chinese medicine are warranted. It is recommended that the international standards and procedures for RCT design should be strictly followed to conduct high-quality trials. At the same time, in order to improve the reporting quality of randomized controlled trials, CONSORT standards should be adopted in the preparation of research reports and submissions. Copyright© by the Chinese Pharmaceutical Association.

[Study on quality standard of Sophora flavescens root extract].

PubMed

Zhao, Feng-chun; Li, Hao; Chen, Liang-mian; Gao, Hui-min; Zhang, Qi-wei; Wang, Zhi-min; Wu, Pi-e

2015-01-01

As a part of the project for the Chinese Pharmacopoeia (2015 edition), the quality standard of Sophora flavescens root extract was investigated and established. According to the methods described in the Appendix of Chinese Pharmacopoeia (2010 edition), the water and ash inspections were carried out. The marker components trifolirhizin, sophoraflavanone G, oxymatrine and oxysophocarpine in the samples were identified by qualitative TLC. The determination of oxymatrine, matrine, oxysophocarpine and sophocarpine was conducted by HPLC and the total flavonoids were measured by ultraviolet spectrophotometry, using sophoraflavanone G as reference substance. The results indicated the spots on the plate were clear with good resolution and the contents of oxymatrine, matrine, oxysophocarpine and sophocarpine in the 13 batches of the samples were 3.87% - 11.1%, 0.970% - 4.33%, 1.30% - 2.59% and 0.260% - 1.14%, respectively. The total flavoids in the 13 batches of the samples were 3.88% - 7.93%. In the study, the validated methods were reproducible and the established quality standard was feasible, which could be used for the quality control of S. flavescens root extract and related preparations.

Disk diffusion quality control guidelines for NVP-PDF 713: a novel peptide deformylase inhibitor.

PubMed

Anderegg, Tamara R; Jones, Ronald N

2004-01-01

NVP-PDF713 is a peptide deformylase inhibitor that has emerged as a candidate for treating Gram-positive infections and selected Gram-negative species that commonly cause community-acquired respiratory tract infections. This report summarizes the results of a multi-center (seven participants) disk diffusion quality control (QC) investigation for NVP PDF-713 using guidelines of the National Committee for Clinical Laboratory Standards and the standardized disk diffusion method. A total of 420 NVP-PDF 713 zone diameter values were generated for each QC organism. The proposed zone diameter ranges contained 97.6-99.8% of the reported participant results and were: Staphylococcus aureus ATCC 25923 (25-35 mm), Streptococcus pneumoniae ATCC 49619 (30-37 mm), and Haemophilus influenzae ATCC 49247 (24-32 mm). These QC criteria for the disk diffusion method should be applied during the NVP-PDF 713 clinical trials to maximize test accuracy.

Surveillance of drug resistance for tuberculosis control: why and how?

PubMed

Chaulet, P; Boulahbal, F; Grosset, J

1995-12-01

The resistance of Mycobacterium tuberculosis to antibiotics, which reflects the quality of the chemotherapy applied in the community, is one of the elements of epidemiological surveillance used in national tuberculosis programmes. Measurement of drug resistance poses problems for biologists in standardization of laboratory methods and quality control. The definition of rates of acquired and primary drug resistance also necessitates standardization in the methods used to collect information transmitted by clinicians. Finally, the significance of the rates calculated depends on the choice of the patients sample on which sensitivity tests have been performed. National surveys of drug resistance therefore require multidisciplinary participation in order to select the only useful indicators: rates of primary resistance and of acquired resistance. These indicators, gathered in representative groups of patients over a long period, are a measurement of the impact of modern chemotherapy regimens on bacterial ecology.

Ensuring Quality in AFRINEST and SATT

PubMed Central

2013-01-01

Background: Three randomized open-label clinical trials [Simplified Antibiotic Therapy Trial (SATT) Bangladesh, SATT Pakistan and African Neonatal Sepsis Trial (AFRINEST)] were developed to test the equivalence of simplified antibiotic regimens compared with the standard regimen of 7 days of parenteral antibiotics. These trials were originally conceived and designed separately; subsequently, significant efforts were made to develop and implement a common protocol and approach. Previous articles in this supplement briefly describe the specific quality control methods used in the individual trials; this article presents additional information about the systematic approaches used to minimize threats to validity and ensure quality across the trials. Methods: A critical component of quality control for AFRINEST and SATT was striving to eliminate variation in clinical assessments and decisions regarding eligibility, enrollment and treatment outcomes. Ensuring appropriate and consistent clinical judgment was accomplished through standardized approaches applied across the trials, including training, assessment of clinical skills and refresher training. Standardized monitoring procedures were also applied across the trials, including routine (day-to-day) internal monitoring of performance and adherence to protocols, systematic external monitoring by funding agencies and external monitoring by experienced, independent trial monitors. A group of independent experts (Technical Steering Committee/Technical Advisory Group) provided regular monitoring and technical oversight for the trials. Conclusions: Harmonization of AFRINEST and SATT have helped to ensure consistency and quality of implementation, both internally and across the trials as a whole, thereby minimizing potential threats to the validity of the trials’ results. PMID:23945575

A Review of Surface Water Quality Models

PubMed Central

Li, Shibei; Jia, Peng; Qi, Changjun; Ding, Feng

2013-01-01

Surface water quality models can be useful tools to simulate and predict the levels, distributions, and risks of chemical pollutants in a given water body. The modeling results from these models under different pollution scenarios are very important components of environmental impact assessment and can provide a basis and technique support for environmental management agencies to make right decisions. Whether the model results are right or not can impact the reasonability and scientificity of the authorized construct projects and the availability of pollution control measures. We reviewed the development of surface water quality models at three stages and analyzed the suitability, precisions, and methods among different models. Standardization of water quality models can help environmental management agencies guarantee the consistency in application of water quality models for regulatory purposes. We concluded the status of standardization of these models in developed countries and put forward available measures for the standardization of these surface water quality models, especially in developing countries. PMID:23853533

Quantitative Determination of Bioactive Constituents in Noni Juice by High-performance Liquid Chromatography with Electrospray Ionization Triple Quadrupole Mass Spectrometry

PubMed Central

Yan, Yongqiu; Lu, Yu; Jiang, Shiping; Jiang, Yu; Tong, Yingpeng; Zuo, Limin; Yang, Jun; Gong, Feng; Zhang, Ling; Wang, Ping

2018-01-01

Background: Noni juice has been extensively used as folk medicine for the treatment of arthritis, infections, analgesic, colds, cancers, and diabetes by Polynesians for many years. Due to the lack of standard scientific evaluation methods, various kinds of commercial Noni juice with different quality and price were available on the market. Objective: To establish a sensitive, reliable, and accurate high-performance liquid chromatography with electrospray ionization triple quadrupole mass spectrometry (HPLC-ESI-MS/MS) method for separation, identification, and simultaneous quantitative analysis of bioactive constituents in Noni juice. Materials and Methods: The analytes and eight batches of commercially available samples from different origins were separated and analyzed by the HPLC-ESI-MS/MS method on an Agilent ZORBAX SB-C18 (150 mm × 4.6 mm i.d., 5 μm) column using a gradient elution of acetonitrile-methanol-0.05% glacial acetic acid in water (v/v) at a constant flow rate of 0.5 mL/min. Results: Seven components were identification and all of the assay parameters were within the required limits. Components were within the correlation coefficient values (R2 ≥ 0.9993) at the concentration ranges tested. The precision of the assay method was <0.91% and the repeatability between 1.36% and 3.31%. The accuracy varied from 96.40% to 103.02% and the relative standard deviations of stability were <3.91%. Samples from the same origin showed similar content while different origins showed significant different result. Conclusions: The developed methods would provide a reliable basis and be useful in the establishment of a rational quality control standard of Noni juice. SUMMARY Separation, identification, and simultaneous quantitative analysis method of seven bioactive constituents in Noni juice is originally developed by high-performance liquid chromatography with electrospray ionization triple quadrupole mass spectrometryThe presented method was successfully applied to the quality control of eight batches of commercially available samples of Noni juiceThis method is simple, sensitive, reliable, accurate, and efficient method with strong specificity, good precision, and high recovery rate and provides a reliable basis for quality control of Noni juice. Abbreviations used: HPLC-ESI-MS/MS: High-performance liquid chromatography with electrospray ionization triple quadrupole mass spectrometry, LOD: Limit of detection, LOQ: Limit of quantitation, S/N: Signal-to-noise ratio, RSD: Relative standard deviations, DP: Declustering potential, CE: Collision energy, MRM: Multiple reaction monitoring, RT: Retention time. PMID:29576704

Colorado Air Quality Control Regulations and Ambient Air Quality Standards.

ERIC Educational Resources Information Center

Colorado State Dept. of Health, Denver. Div. of Air Pollution Control.

Regulations and standards relative to air quality control in Colorado are defined in this publication. Presented first are definitions of terms, a statement of intent, and general provisions applicable to all emission control regulations adopted by the Colorado Air Pollution Control Commission. Following this, three regulations are enumerated: (1)…

Automated image quality assessment for chest CT scans.

PubMed

Reeves, Anthony P; Xie, Yiting; Liu, Shuang

2018-02-01

Medical image quality needs to be maintained at standards sufficient for effective clinical reading. Automated computer analytic methods may be applied to medical images for quality assessment. For chest CT scans in a lung cancer screening context, an automated quality assessment method is presented that characterizes image noise and image intensity calibration. This is achieved by image measurements in three automatically segmented homogeneous regions of the scan: external air, trachea lumen air, and descending aorta blood. Profiles of CT scanner behavior are also computed. The method has been evaluated on both phantom and real low-dose chest CT scans and results show that repeatable noise and calibration measures may be realized by automated computer algorithms. Noise and calibration profiles show relevant differences between different scanners and protocols. Automated image quality assessment may be useful for quality control for lung cancer screening and may enable performance improvements to automated computer analysis methods. © 2017 American Association of Physicists in Medicine.

Internal quality assurance in a clinical virology laboratory. II. Internal quality control.

PubMed Central

Gray, J J; Wreghitt, T G; McKee, T A; McIntyre, P; Roth, C E; Smith, D J; Sutehall, G; Higgins, G; Geraghty, R; Whetstone, R

1995-01-01

AIMS--In April 1991 additional quality control procedures were introduced into the virology section of the Clinical Microbiology and Public Health Laboratory, Cambridge. Internal quality control (IQC) samples were gradually included in the serological assays performed in the laboratory and supplemented kit controls and standard sera. METHODS--From April 1991 to December 1993, 2421 IQC procedures were carried out with reference sera. RESULTS--The IQC samples were evaluated according to the Westgard rules. Violations were recorded in 60 of 1808 (3.3%) controls and were highest in the IQC samples of complement fixation tests (25/312 (8%) of controls submitted for complement fixation tests). CONCLUSIONS--The inclusion of IQC samples in the serological assays performed in the laboratory has highlighted batch to batch variation in commercial assays. The setting of acceptable limits for the IQC samples has increased confidence in the validity of assay results. PMID:7730475

Halogenated peptides as internal standards (H-PINS): introduction of an MS-based internal standard set for liquid chromatography-mass spectrometry.

PubMed

Mirzaei, Hamid; Brusniak, Mi-Youn; Mueller, Lukas N; Letarte, Simon; Watts, Julian D; Aebersold, Ruedi

2009-08-01

As the application for quantitative proteomics in the life sciences has grown in recent years, so has the need for more robust and generally applicable methods for quality control and calibration. The reliability of quantitative proteomics is tightly linked to the reproducibility and stability of the analytical platforms, which are typically multicomponent (e.g. sample preparation, multistep separations, and mass spectrometry) with individual components contributing unequally to the overall system reproducibility. Variations in quantitative accuracy are thus inevitable, and quality control and calibration become essential for the assessment of the quality of the analyses themselves. Toward this end, the use of internal standards cannot only assist in the detection and removal of outlier data acquired by an irreproducible system (quality control) but can also be used for detection of changes in instruments for their subsequent performance and calibration. Here we introduce a set of halogenated peptides as internal standards. The peptides are custom designed to have properties suitable for various quality control assessments, data calibration, and normalization processes. The unique isotope distribution of halogenated peptides makes their mass spectral detection easy and unambiguous when spiked into complex peptide mixtures. In addition, they were designed to elute sequentially over an entire aqueous to organic LC gradient and to have m/z values within the commonly scanned mass range (300-1800 Da). In a series of experiments in which these peptides were spiked into an enriched N-glycosite peptide fraction (i.e. from formerly N-glycosylated intact proteins in their deglycosylated form) isolated from human plasma, we show the utility and performance of these halogenated peptides for sample preparation and LC injection quality control as well as for retention time and mass calibration. Further use of the peptides for signal intensity normalization and retention time synchronization for selected reaction monitoring experiments is also demonstrated.

The Explication of Quality Standards in Self-Evaluation

ERIC Educational Resources Information Center

Bronkhorst, Larike H.; Baartman, Liesbeth K. J.; Stokking, Karel M.

2012-01-01

Education aiming at students' competence development asks for new assessment methods. The quality of these methods needs to be assured using adapted quality criteria and accompanying standards. As such standards are not widely available, this study sets out to examine what level of compliance with quality criteria stakeholders consider…

[Application of fingerprint chromatogram in quality control of Shen-Mai injection].

PubMed

Shi, Xian-zhe; Yang, Jun; Zhao, Chun-xia; Xiong, Jian-hui; Xu, Guo-wang

2002-07-01

The theory and practice of traditional Chinese medicine require some comprehensive methods to assess quality of the Chinese herbal medication. Fingerprint chromatogram is one of the feasible approaches to evaluate the quality of Chinese herbal medication. So the fingerprint chromatogram of Shen-Mai injection was established by using reversed-phase high performance liquid chromatography. The chromatographic conditions were as follows: a Hypersil C18 column was used; the mobile phase was composed of water (A) and acetontrile (B) with linear gradient elution (0-50 min, 5%-95% B, volume fraction); the flow rate was 1.0 mL/min and the UV absorbance detection was set at 202 nm. The peak-area ratios of twenty-three fingerprint peaks and internal standard (diphenyl) were taken as the criteria for quality control. The quality differences in various batches and various manufacturers of Shen-Mai injections were investigated by projection discriminance based on principal component analysis. The results show the method developed is convenient, reliable and applicable for the quality control analysis of Shen-Mai injection.

42 CFR 493.1425 - Standard; Testing personnel responsibilities.

Code of Federal Regulations, 2010 CFR

2010-10-01

... laboratory's quality control policies, document all quality control activities, instrument and procedural... HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Personnel for Nonwaived Testing Laboratories Performing Moderate Complexity Testing § 493.1425 Standard; Testing personnel...

Albuquerque constructed wetlands pilot project: Summary and status of City of Albuquerque project, September 1995

Treesearch

Steven Glass; Joan Thullen; Jim Sartoris; Rick Roline

1996-01-01

The Pueblo of Isleta, located five miles downstream from Albuquerque, and the NM Water Quality Control Commission has established strict water quality standards for the Rio Grande, and it has become necessary for the Albuquerque Public Works Department to pursue methods to enhance the purity of treated municipal wastewater effluent produced at the Southside Water...

Importance of implementing an analytical quality control system in a core laboratory.

PubMed

Marques-Garcia, F; Garcia-Codesal, M F; Caro-Narros, M R; Contreras-SanFeliciano, T

2015-01-01

The aim of the clinical laboratory is to provide useful information for screening, diagnosis and monitoring of disease. The laboratory should ensure the quality of extra-analytical and analytical process, based on set criteria. To do this, it develops and implements a system of internal quality control, designed to detect errors, and compare its data with other laboratories, through external quality control. In this way it has a tool to detect the fulfillment of the objectives set, and in case of errors, allowing corrective actions to be made, and ensure the reliability of the results. This article sets out to describe the design and implementation of an internal quality control protocol, as well as its periodical assessment intervals (6 months) to determine compliance with pre-determined specifications (Stockholm Consensus(1)). A total of 40 biochemical and 15 immunochemical methods were evaluated using three different control materials. Next, a standard operation procedure was planned to develop a system of internal quality control that included calculating the error of the analytical process, setting quality specifications, and verifying compliance. The quality control data were then statistically depicted as means, standard deviations, and coefficients of variation, as well as systematic, random, and total errors. The quality specifications were then fixed and the operational rules to apply in the analytical process were calculated. Finally, our data were compared with those of other laboratories through an external quality assurance program. The development of an analytical quality control system is a highly structured process. This should be designed to detect errors that compromise the stability of the analytical process. The laboratory should review its quality indicators, systematic, random and total error at regular intervals, in order to ensure that they are meeting pre-determined specifications, and if not, apply the appropriate corrective actions. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.

42 CFR 440.260 - Methods and standards to assure quality of services.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 4 2010-10-01 2010-10-01 false Methods and standards to assure quality of services. 440.260 Section 440.260 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH... and Limits Applicable to All Services § 440.260 Methods and standards to assure quality of services...

Quantitative Determination of Bioactive Constituents in Noni Juice by High-performance Liquid Chromatography with Electrospray Ionization Triple Quadrupole Mass Spectrometry.

PubMed

Yan, Yongqiu; Lu, Yu; Jiang, Shiping; Jiang, Yu; Tong, Yingpeng; Zuo, Limin; Yang, Jun; Gong, Feng; Zhang, Ling; Wang, Ping

2018-01-01

Noni juice has been extensively used as folk medicine for the treatment of arthritis, infections, analgesic, colds, cancers, and diabetes by Polynesians for many years. Due to the lack of standard scientific evaluation methods, various kinds of commercial Noni juice with different quality and price were available on the market. To establish a sensitive, reliable, and accurate high-performance liquid chromatography with electrospray ionization triple quadrupole mass spectrometry (HPLC-ESI-MS/MS) method for separation, identification, and simultaneous quantitative analysis of bioactive constituents in Noni juice. The analytes and eight batches of commercially available samples from different origins were separated and analyzed by the HPLC-ESI-MS/MS method on an Agilent ZORBAX SB-C 18 (150 mm × 4.6 mm i.d., 5 μm) column using a gradient elution of acetonitrile-methanol-0.05% glacial acetic acid in water (v/v) at a constant flow rate of 0.5 mL/min. Seven components were identification and all of the assay parameters were within the required limits. Components were within the correlation coefficient values ( R 2 ≥ 0.9993) at the concentration ranges tested. The precision of the assay method was <0.91% and the repeatability between 1.36% and 3.31%. The accuracy varied from 96.40% to 103.02% and the relative standard deviations of stability were <3.91%. Samples from the same origin showed similar content while different origins showed significant different result. The developed methods would provide a reliable basis and be useful in the establishment of a rational quality control standard of Noni juice. Separation, identification, and simultaneous quantitative analysis method of seven bioactive constituents in Noni juice is originally developed by high-performance liquid chromatography with electrospray ionization triple quadrupole mass spectrometryThe presented method was successfully applied to the quality control of eight batches of commercially available samples of Noni juiceThis method is simple, sensitive, reliable, accurate, and efficient method with strong specificity, good precision, and high recovery rate and provides a reliable basis for quality control of Noni juice. Abbreviations used: HPLC-ESI-MS/MS: High-performance liquid chromatography with electrospray ionization triple quadrupole mass spectrometry, LOD: Limit of detection, LOQ: Limit of quantitation, S/N: Signal-to-noise ratio, RSD: Relative standard deviations, DP: Declustering potential, CE: Collision energy, MRM: Multiple reaction monitoring, RT: Retention time.

Performance Assessment of Internal Quality Control (IQC) Products in Blood Transfusion Compatibility Testing in China

PubMed Central

Li, Jing-Jing; Gao, Qi; Liu, Zhi-Dong; Kang, Qiong-Hua; Hou, Yi-Jun; Zhang, Luo-Chuan; Hu, Xiao-Mei; Li, Jie; Zhang, Juan

2015-01-01

Internal quality control (IQC) is a critical component of laboratory quality management, and IQC products can determine the reliability of testing results. In China, given the fact that most blood transfusion compatibility laboratories do not employ IQC products or do so minimally, there is a lack of uniform and standardized IQC methods. To explore the reliability of IQC products and methods, we studied 697 results from IQC samples in our laboratory from 2012 to 2014. The results showed that the sensitivity and specificity of the IQCs in anti-B testing were 100% and 99.7%, respectively. The sensitivity and specificity of the IQCs in forward blood typing, anti-A testing, irregular antibody screening, and cross-matching were all 100%. The reliability analysis indicated that 97% of anti-B testing results were at a 99% confidence level, and 99.9% of forward blood typing, anti-A testing, irregular antibody screening, and cross-matching results were at a 99% confidence level. Therefore, our IQC products and methods are highly sensitive, specific, and reliable. Our study paves the way for the establishment of a uniform and standardized IQC method for pre-transfusion compatibility testing in China and other parts of the world. PMID:26488582

Quantitative analysis of image quality for acceptance and commissioning of an MRI simulator with a semiautomatic method.

PubMed

Chen, Xinyuan; Dai, Jianrong

2018-05-01

Magnetic Resonance Imaging (MRI) simulation differs from diagnostic MRI in purpose, technical requirements, and implementation. We propose a semiautomatic method for image acceptance and commissioning for the scanner, the radiofrequency (RF) coils, and pulse sequences for an MRI simulator. The ACR MRI accreditation large phantom was used for image quality analysis with seven parameters. Standard ACR sequences with a split head coil were adopted to examine the scanner's basic performance. The performance of simulation RF coils were measured and compared using the standard sequence with different clinical diagnostic coils. We used simulation sequences with simulation coils to test the quality of image and advanced performance of the scanner. Codes and procedures were developed for semiautomatic image quality analysis. When using standard ACR sequences with a split head coil, image quality passed all ACR recommended criteria. The image intensity uniformity with a simulation RF coil decreased about 34% compared with the eight-channel diagnostic head coil, while the other six image quality parameters were acceptable. Those two image quality parameters could be improved to more than 85% by built-in intensity calibration methods. In the simulation sequences test, the contrast resolution was sensitive to the FOV and matrix settings. The geometric distortion of simulation sequences such as T1-weighted and T2-weighted images was well-controlled in the isocenter and 10 cm off-center within a range of ±1% (2 mm). We developed a semiautomatic image quality analysis method for quantitative evaluation of images and commissioning of an MRI simulator. The baseline performances of simulation RF coils and pulse sequences have been established for routine QA. © 2018 The Authors. Journal of Applied Clinical Medical Physics published by Wiley Periodicals, Inc. on behalf of American Association of Physicists in Medicine.

[Investigation on pattern of quality control for Chinese materia medica based on famous-region drug and bioassay--the work reference].

PubMed

Yan, Dan; Xiao, Xiaohe

2011-05-01

Selection and standardization of the work reference are the technical issues to be faced with in the bioassay of Chinese materia medica. Taking the bioassay of Coptis chinensis. as an example, the manufacture process of the famous-region drugs extraction was explained from the aspects of original identification, routine examination, component analysis and bioassay. The common technologies were extracted, and the selection and standardization procedures of the work reference for the bioassay of Chinese materia medica were drawn up, so as to provide technical support for constructing a new mode and method of the quality control of Chinese materia medica based on the famous-region drugs and bioassay.

77 FR 28338 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Reasonably Available...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-14

... Promulgation of Air Quality Implementation Plans; Maryland; Reasonably Available Control Technology for the 1997 8-Hour Ozone National Ambient Air Quality Standard AGENCY: Environmental Protection Agency (EPA... available control technology (RACT) for the 1997 8-hour ozone national ambient air quality standard (NAAQS...

Effect of Sleep Hygiene Education on Sleep Quality in Hemodialysis Patients

PubMed Central

Soleimani, Farzaneh; Hasanpour-Dehkordi, Ali

2016-01-01

Introduction Sleep is referred a regular, recurring and easily revocable state of organism which is characterized by relative immobility and significant increase in response threshold to environmental stimuli. Sleep disorders are common among haemodialysis patients. Aim The aim of this study was to investigate the effect of sleep hygiene education on sleep quality in haemodialysis patients. Materials and Methods This study is a randomized controlled clinical trial. The participants of this study were 60 haemodialysis patients admitted to the Dialysis Center of Shahid Ayatollah Madani Hospital of Khoy, affiliated with the Urmia University of Medical Sciences. Sampling was done randomly and the partcipants were randomly divided into intervention group (30 patients) and control group (30 patients). Sleep quality of participants was measured before and after the intervention by Pittsburgh Sleep Quality Index (PSQI). Training process for sleep hygiene behaviours was presented to the participants face-to-face. The data were analysed using SPSS 16. Results A significant difference in the mean (standard deviation) score for PSQI (p<0.001) was observed before and after intervention in the intervention group, while in the control group, the difference was not significant (p=0.704), In addition, a significant difference was observed in the mean (standard deviation) score for PSQI between the two, intervention and control groups after the educational intervention (p=0.034). Conclusion Sleep hygiene education, alongside other appro-aches, is a low-cost, accessible and practical method which can be implemented within a short period of time. PMID:28208884

Comparison of four methods of establishing control limits for monitoring quality controls in infectious disease serology testing.

PubMed

Dimech, Wayne; Karakaltsas, Marina; Vincini, Giuseppe A

2018-05-25

A general trend towards conducting infectious disease serology testing in centralized laboratories means that quality control (QC) principles used for clinical chemistry testing are applied to infectious disease testing. However, no systematic assessment of methods used to establish QC limits has been applied to infectious disease serology testing. A total of 103 QC data sets, obtained from six different infectious disease serology analytes, were parsed through standard methods for establishing statistical control limits, including guidelines from Public Health England, USA Clinical and Laboratory Standards Institute (CLSI), German Richtlinien der Bundesärztekammer (RiliBÄK) and Australian QConnect. The percentage of QC results failing each method was compared. The percentage of data sets having more than 20% of QC results failing Westgard rules when the first 20 results were used to calculate the mean±2 standard deviation (SD) ranged from 3 (2.9%) for R4S to 66 (64.1%) for 10X rule, whereas the percentage ranged from 0 (0%) for R4S to 32 (40.5%) for 10X when the first 100 results were used to calculate the mean±2 SD. By contrast, the percentage of data sets with >20% failing the RiliBÄK control limits was 25 (24.3%). Only two data sets (1.9%) had more than 20% of results outside the QConnect Limits. The rate of failure of QCs using QConnect Limits was more applicable for monitoring infectious disease serology testing compared with UK Public Health, CLSI and RiliBÄK, as the alternatives to QConnect Limits reported an unacceptably high percentage of failures across the 103 data sets.

Effect of production variables on microbiological removal in locally-produced ceramic filters for household water treatment.

PubMed

Lantagne, Daniele; Klarman, Molly; Mayer, Ally; Preston, Kelsey; Napotnik, Julie; Jellison, Kristen

2010-06-01

Diarrhoeal diseases cause an estimated 1.87 million child deaths per year. Point-of-use filtration using locally made ceramic filters improves microbiological quality of stored drinking water and prevents diarrhoeal disease. Scaling-up ceramic filtration is inhibited by lack of universal quality control standards. We investigated filter production variables to determine their affect on microbiological removal during 5-6 weeks of simulated normal use. Decreases in the clay:sawdust ratio and changes in the burnable decreased effectiveness of the filter. Method of silver application and shape of filter did not impact filter effectiveness. A maximum flow rate of 1.7 l(-hr) was established as a potential quality control measure for one particular filter to ensure 99% (2- log(10)) removal of total coliforms. Further research is indicated to determine additional production variables associated with filter effectiveness and develop standardized filter production procedures prior to scaling-up.

Cost Effectiveness Of Selected Roadway Dust Control Methods For Eagle River, Alaska

DOT National Transportation Integrated Search

1988-01-01

The U.S. Environmental Protection Agency has set air quality standards for airborne particulates with diameters equal to or less than ten microns (PM10 particulates). These particulates have been correlated with respiratory illnesses. The primary sta...

Human Connectome Project Informatics: quality control, database services, and data visualization

PubMed Central

Marcus, Daniel S.; Harms, Michael P.; Snyder, Abraham Z.; Jenkinson, Mark; Wilson, J Anthony; Glasser, Matthew F.; Barch, Deanna M.; Archie, Kevin A.; Burgess, Gregory C.; Ramaratnam, Mohana; Hodge, Michael; Horton, William; Herrick, Rick; Olsen, Timothy; McKay, Michael; House, Matthew; Hileman, Michael; Reid, Erin; Harwell, John; Coalson, Timothy; Schindler, Jon; Elam, Jennifer S.; Curtiss, Sandra W.; Van Essen, David C.

2013-01-01

The Human Connectome Project (HCP) has developed protocols, standard operating and quality control procedures, and a suite of informatics tools to enable high throughput data collection, data sharing, automated data processing and analysis, and data mining and visualization. Quality control procedures include methods to maintain data collection consistency over time, to measure head motion, and to establish quantitative modality-specific overall quality assessments. Database services developed as customizations of the XNAT imaging informatics platform support both internal daily operations and open access data sharing. The Connectome Workbench visualization environment enables user interaction with HCP data and is increasingly integrated with the HCP's database services. Here we describe the current state of these procedures and tools and their application in the ongoing HCP study. PMID:23707591

Economic Assessment and Budgetary Impact of a Telemedicine Procedure and Spirometry Quality Control in the Primary Care Setting.

PubMed

Marina, Nuria; Bayón, Juan Carlos; López de Santa María, Elena; Gutiérrez, Asunción; Inchausti, Marta; Bustamante, Victor; Gáldiz, Juan B

2016-01-01

To evaluate the economic impact of a telemedicine procedure designed to improve the quality of lung function testing (LFT) in primary care in a public healthcare system, compared with the standard method. The economic impact of 9,039 LFTs performed in 51 health centers (2010-2013) using telespirometry (TS) compared to standard spirometry (SS) was studied. TS costs more per unit than SS (€47.80 vs. €39.70) (2013), but the quality of the TS procedure is superior (84% good quality, compared to 61% using the standard procedure). Total cost of TS was €431,974 (compared with €358,306€ for SS), generating an economic impact of €73,668 (2013). The increase in cost for good quality LFT performed using TS was €34,030 (2010) and €144,295 (2013), while the costs of poor quality tests fell by €15,525 (2010) and 70,627€ (2013). The cost-effectiveness analysis concludes that TS is 23% more expensive and 46% more effective. Healthcare costs consequently fall as the number of LFTs performed by TS rises. Avoiding poor quality, invalid LFTs generates savings that compensate for the increased costs of performing LFTs with TS, making it a cost-effective method. Copyright © 2014 SEPAR. Published by Elsevier Espana. All rights reserved.

GC-C-IRMS in routine doping control practice: 3 years of drug testing data, quality control and evolution of the method.

PubMed

Polet, Michael; Van Eenoo, Peter

2015-06-01

In order to detect the misuse of endogenous anabolic steroids, doping control laboratories require methods that allow differentiation between endogenous steroids and their synthetic copies. Gas chromatography combustion isotope ratio mass spectrometry (GC-C-IRMS) is capable of measuring the carbon isotope ratio of urinary steroids and this allows differentiation between both. GC-C-IRMS and its application to doping control has evolved a lot during the last decade and so have the World Anti-Doping Agency (WADA) technical documents that describe how GC-C-IRMS should be applied. Especially the WADA technical document of 2014 introduced a number of obligatory quality controls and a fixed methodology that should be used by all the doping control laboratories. This document imposed more uniform methods between the laboratories in order to decrease the interlaboratory standard deviation and acquire similar results for the analysis of the same urine samples. In this paper, 3 years of drug testing data of our GC-C-IRMS method in routine doping control practice is described, with an emphasis on the new WADA technical document and its implementation. Useful data for other doping control laboratories is presented focussing on general method setup, quality control and data collected from routine samples. The paper concentrates on how IRMS results shift or remain similar by switching to the 2014 WADA technical document and gives insight in a straightforward approach to calculate the measurement uncertainty.

Evaluation of the methods for enumerating coliform bacteria from water samples using precise reference standards.

PubMed

Wohlsen, T; Bates, J; Vesey, G; Robinson, W A; Katouli, M

2006-04-01

To use BioBall cultures as a precise reference standard to evaluate methods for enumeration of Escherichia coli and other coliform bacteria in water samples. Eight methods were evaluated including membrane filtration, standard plate count (pour and spread plate methods), defined substrate technology methods (Colilert and Colisure), the most probable number method and the Petrifilm disposable plate method. Escherichia coli and Enterobacter aerogenes BioBall cultures containing 30 organisms each were used. All tests were performed using 10 replicates. The mean recovery of both bacteria varied with the different methods employed. The best and most consistent results were obtained with Petrifilm and the pour plate method. Other methods either yielded a low recovery or showed significantly high variability between replicates. The BioBall is a very suitable quality control tool for evaluating the efficiency of methods for bacterial enumeration in water samples.

Standardization of Laboratory Methods for the PERCH Study

PubMed Central

Karron, Ruth A.; Morpeth, Susan C.; Bhat, Niranjan; Levine, Orin S.; Baggett, Henry C.; Brooks, W. Abdullah; Feikin, Daniel R.; Hammitt, Laura L.; Howie, Stephen R. C.; Knoll, Maria Deloria; Kotloff, Karen L.; Madhi, Shabir A.; Scott, J. Anthony G.; Thea, Donald M.; Adrian, Peter V.; Ahmed, Dilruba; Alam, Muntasir; Anderson, Trevor P.; Antonio, Martin; Baillie, Vicky L.; Dione, Michel; Endtz, Hubert P.; Gitahi, Caroline; Karani, Angela; Kwenda, Geoffrey; Maiga, Abdoul Aziz; McClellan, Jessica; Mitchell, Joanne L.; Morailane, Palesa; Mugo, Daisy; Mwaba, John; Mwansa, James; Mwarumba, Salim; Nyongesa, Sammy; Panchalingam, Sandra; Rahman, Mustafizur; Sawatwong, Pongpun; Tamboura, Boubou; Toure, Aliou; Whistler, Toni; O’Brien, Katherine L.; Murdoch, David R.

2017-01-01

Abstract The Pneumonia Etiology Research for Child Health study was conducted across 7 diverse research sites and relied on standardized clinical and laboratory methods for the accurate and meaningful interpretation of pneumonia etiology data. Blood, respiratory specimens, and urine were collected from children aged 1–59 months hospitalized with severe or very severe pneumonia and community controls of the same age without severe pneumonia and were tested with an extensive array of laboratory diagnostic tests. A standardized testing algorithm and standard operating procedures were applied across all study sites. Site laboratories received uniform training, equipment, and reagents for core testing methods. Standardization was further assured by routine teleconferences, in-person meetings, site monitoring visits, and internal and external quality assurance testing. Targeted confirmatory testing and testing by specialized assays were done at a central reference laboratory. PMID:28575358

The importance of quality control in validating concentrations ...

EPA Pesticide Factsheets

A national-scale survey of 247 contaminants of emerging concern (CECs), including organic and inorganic chemical compounds, and microbial contaminants, was conducted in source and treated drinking water samples from 25 treatment plants across the United States. Multiple methods were used to determine these CECs, including six analytical methods to measure 174 pharmaceuticals, personal care products, and pesticides. A three-component quality assurance/quality control (QA/QC) program was designed for the subset of 174 CECs which allowed us to assess and compare performances of the methods used. The three components included: 1) a common field QA/QC protocol and sample design, 2) individual investigator-developed method-specific QA/QC protocols, and 3) a suite of 46 method comparison analytes that were determined in two or more analytical methods. Overall method performance for the 174 organic chemical CECs was assessed by comparing spiked recoveries in reagent, source, and treated water over a two-year period. In addition to the 247 CECs reported in the larger drinking water study, another 48 pharmaceutical compounds measured did not consistently meet predetermined quality standards. Methodologies that did not seem suitable for these analytes are overviewed. The need to exclude analytes based on method performance demonstrates the importance of additional QA/QC protocols. This paper compares the method performance of six analytical methods used to measure 174 emer

[Effect analysis on the two total load control methods for poisonous heavy metals].

PubMed

Fu, Guo-Wei

2012-12-01

Firstly it should be made clear that implementation of source total load control for the first type of pollutants is necessary for environmental pollution control legislation and economic structure regulation. This kind of surveillance method has been more practical to be implemented since the Manual of the Industry Discharge Coefficient of First National Pollution Sources Investigation was published. The source total load control and water environment total load control are independent of each other and none of them is redundant, on the other side they can be complementary to each other. In the present, some local planning managers are blurring and confusing the contents and styles of the two surveillance methods. They just use the water total load control to manage all the pollutants, and source total load control is discarded, which results in the loss of control for the first type of pollutants especially for the drinking water source surveillance. There is a big difference between the water quality standards and the water environmental background concentration values for the first type of pollutants in the Environmental quality standard for surface water (GB 3838-88), which means that there are problems such as "relaxing the pollutant discharge permit" and "risk induced by valence state change". Taking an enterprise with 10t electrolytic lead production capacity as an example, there is a big difference between the allowable lead discharged loads by the two total load surveillance methods. In summary, it will bring a lot of harmful effects if the water total load control is implemented for the two types of pollutants, so the source total load control and water environmental total load control should be implemented strictly at the same time.

Linking fish tolerance to water quality criteria for the assessment of environmental flows: A practical method for streamflow regulation and pollution control.

PubMed

Zhao, Changsen; Yang, Shengtian; Liu, Junguo; Liu, Changming; Hao, Fanghua; Wang, Zhonggen; Zhang, Huitong; Song, Jinxi; Mitrovic, Simon M; Lim, Richard P

2018-05-15

The survival of aquatic biota in stream ecosystems depends on both water quantity and quality, and is particularly susceptible to degraded water quality in regulated rivers. Maintenance of environmental flows (e-flows) for aquatic biota with optimum water quantity and quality is essential for sustainable ecosystem services, especially in developing regions with insufficient stream monitoring of hydrology, water quality and aquatic biota. Few e-flow methods are available that closely link aquatic biota tolerances to pollutant concentrations in a simple and practical manner. In this paper a new method was proposed to assess e-flows that aimed to satisfy the requirements of aquatic biota for both the quantity and quality of the streamflow by linking fish tolerances to water quality criteria, or the allowable concentration of pollutants. For better operation of water projects and control of pollutants discharged into streams, this paper presented two coefficients for streamflow adjustment and pollutant control. Assessment of e-flows in the Wei River, the largest tributary of the Yellow River, shows that streamflow in dry seasons failed to meet e-flow requirements. Pollutant influx exerted a large pressure on the aquatic ecosystem, with pollutant concentrations much higher than that of the fish tolerance thresholds. We found that both flow velocity and water temperature exerted great influences on the pollutant degradation rate. Flow velocity had a much greater influence on pollutant degradation than did the standard deviation of flow velocity. This study provides new methods to closely link the tolerance of aquatic biota to water quality criteria for e-flow assessment. The recommended coefficients for streamflow adjustment and pollutant control, to dynamically regulate streamflow and control pollutant discharge, are helpful for river management and ecosystems rehabilitation. The relatively low data requirement also makes the method easy to use efficiently in developing regions, and thus this study has significant implications for managing flows in polluted and regulated rivers worldwide. Copyright © 2018. Published by Elsevier Ltd.

78 FR 30829 - Approval and Promulgation of Air Quality Implementation Plans; Illinois; Air Quality Standards...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-23

... Promulgation of Air Quality Implementation Plans; Illinois; Air Quality Standards Revision AGENCY... the Illinois State Implementation Plan (SIP) to reflect current national ambient air quality standards...) 692-2450. 4. Mail: Pamela Blakley, Chief, Control Strategies Section, Air Programs Branch (AR-18J), U...

Reporting Quality Assessment of Randomized Controlled Trials Published in Nephrology Urology Monthly Journal.

PubMed

Mehrazmay, Alireza; Karambakhsh, Alireza; Salesi, Mahmood

2015-07-01

Randomized controlled trials (RCTs) are important tools for evidence-based health care decisions. It is, therefore, important that they be conducted and reported with the highest possible standards. The aim of this study was to evaluate the reporting quality of the RCTs published in nephrology urology monthly journal and to examine whether there was a change over time in the reporting quality. The quality of each report was assessed using the Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement checklist and a 5-point quality assessment instrument, i.e. the Jadad scale. Eighteen (14 Iranian and 4 non-Iranian) RCTs were published from 2012 to 2014 on topics including renal stone (16.6%), hemodialysis and transplantation (38.8%), and prostate conditions (11.1%). Interventions comprised surgery, drugs, and teaching method in 7 (38 %), 10 (55%), and 1 (5%) of them, respectively. According to the CONSORT checklist, the weakest reported items were registration number, identification as a randomized trial in the title, and settings and locations where the data were collected. The mean Jadad score of the reports was 2.72 ± 1.36 (54% of their maximum possible total score). According to the Jadad and CONSORT scales, there was an increase in the quality of reporting from 2012 to 2014. This assessment shows low reporting quality scores in reports. Training courses for researchers, using standard reporting tools (e.g. CONSORT 2010 Statement checklist), and consultation with methodologists can improve the quality of published RCTs.

Using standard treatment protocols to manage costs and quality of hospital services.

PubMed

Meyer, J W; Feingold, M G

1993-06-01

The current health care environment has made it critically important that hospital costs and quality be managed in an integrated fashion. Promised health care reforms are expected to make cost reduction and quality enhancement only more important. Traditional methods of hospital cost and quality control have largely been replaced by such approaches as practice parameters, outcomes measurement, clinical indicators, clinical paths, benchmarking, patient-centered care, and a focus on patient selection criteria. This Special Report describes an integrated process for strategically managing costs and quality simultaneously, incorporating key elements of many important new quality and cost control tools. By using a multidisciplinary group process to develop standard treatment protocols, hospitals and their medical staffs address the most important services provided within major product lines. Using both clinical and financial data, groups of physicians, nurses, department managers, financial analysts, and administrators redesign key patterns of care within their hospital, incorporating the best practices of their own and other institutions. The outcome of this process is a new, standardized set of clinical guidelines that reduce unnecessary variation in care, eliminate redundant interventions, establish clear lines of communication for all caregivers, and reduce the cost of each stay. The hospital, medical staff, and patients benefit from the improved opportunities for managed care contracting, more efficient hospital systems, consensus-based quality measures, and reductions in the cost of care. STPs offer a workable and worthwhile approach to positioning the hospital of the 1990s for operational efficiency and cost and quality competitiveness.

Microbiological methods for the water recovery systems test, revision 1.1

NASA Technical Reports Server (NTRS)

Rhoads, Tim; Kilgore, M. V., Jr.; Mikell, A. T., Jr.

1990-01-01

Current microbiological parameters specified to verify microbiological quality of Space Station Freedom water quality include the enumeration of total bacteria, anaerobes, aerobes, yeasts and molds, enteric bacteria, gram positives, gram negatives, and E. coli. In addition, other parameters have been identified as necessary to support the Water Recovery Test activities to be conducted at the NASA/MSFC later this year. These other parameters include aerotolerant eutrophic mesophiles, legionellae, and an additional method for heterotrophic bacteria. If inter-laboratory data are to be compared to evaluate quality, analytical methods must be eliminated as a variable. Therefore, each participating laboratory must utilize the same analytical methods and procedures. Without this standardization, data can be neither compared nor validated between laboratories. Multiple laboratory participation represents a conservative approach to insure quality and completeness of data. Invariably, sample loss will occur in transport and analyses. Natural variance is a reality on any test of this magnitude and is further enhanced because biological entities, capable of growth and death, are specific parameters of interest. The large variation due to the participation of human test subjects has been noted with previous testing. The resultant data might be dismissed as 'out of control' unless intra-laboratory control is included as part of the method or if participating laboratories are not available for verification. The purpose of this document is to provide standardized laboratory procedures for the enumeration of certain microorganisms in water and wastewater specific to the water recovery systems test. The document consists of ten separate cultural methods and one direct count procedure. It is not intended nor is it implied to be a complete microbiological methods manual.

Data Acceptance Criteria for Standardized Human-Associated Fecal Source Identification Quantitative Real-Time PCR Methods.

PubMed

Shanks, Orin C; Kelty, Catherine A; Oshiro, Robin; Haugland, Richard A; Madi, Tania; Brooks, Lauren; Field, Katharine G; Sivaganesan, Mano

2016-05-01

There is growing interest in the application of human-associated fecal source identification quantitative real-time PCR (qPCR) technologies for water quality management. The transition from a research tool to a standardized protocol requires a high degree of confidence in data quality across laboratories. Data quality is typically determined through a series of specifications that ensure good experimental practice and the absence of bias in the results due to DNA isolation and amplification interferences. However, there is currently a lack of consensus on how best to evaluate and interpret human fecal source identification qPCR experiments. This is, in part, due to the lack of standardized protocols and information on interlaboratory variability under conditions for data acceptance. The aim of this study is to provide users and reviewers with a complete series of conditions for data acceptance derived from a multiple laboratory data set using standardized procedures. To establish these benchmarks, data from HF183/BacR287 and HumM2 human-associated qPCR methods were generated across 14 laboratories. Each laboratory followed a standardized protocol utilizing the same lot of reference DNA materials, DNA isolation kits, amplification reagents, and test samples to generate comparable data. After removal of outliers, a nested analysis of variance (ANOVA) was used to establish proficiency metrics that include lab-to-lab, replicate testing within a lab, and random error for amplification inhibition and sample processing controls. Other data acceptance measurements included extraneous DNA contamination assessments (no-template and extraction blank controls) and calibration model performance (correlation coefficient, amplification efficiency, and lower limit of quantification). To demonstrate the implementation of the proposed standardized protocols and data acceptance criteria, comparable data from two additional laboratories were reviewed. The data acceptance criteria proposed in this study should help scientists, managers, reviewers, and the public evaluate the technical quality of future findings against an established benchmark. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

Data-quality measures for stakeholder-implemented watershed-monitoring programs

USGS Publications Warehouse

Greve, Adrienne I.

2002-01-01

Community-based watershed groups, many of which collect environmental data, have steadily increased in number over the last decade. The data generated by these programs are often underutilized due to uncertainty in the quality of data produced. The incorporation of data-quality measures into stakeholder monitoring programs lends statistical validity to data. Data-quality measures are divided into three steps: quality assurance, quality control, and quality assessment. The quality-assurance step attempts to control sources of error that cannot be directly quantified. This step is part of the design phase of a monitoring program and includes clearly defined, quantifiable objectives, sampling sites that meet the objectives, standardized protocols for sample collection, and standardized laboratory methods. Quality control (QC) is the collection of samples to assess the magnitude of error in a data set due to sampling, processing, transport, and analysis. In order to design a QC sampling program, a series of issues needs to be considered: (1) potential sources of error, (2) the type of QC samples, (3) inference space, (4) the number of QC samples, and (5) the distribution of the QC samples. Quality assessment is the process of evaluating quality-assurance measures and analyzing the QC data in order to interpret the environmental data. Quality assessment has two parts: one that is conducted on an ongoing basis as the monitoring program is running, and one that is conducted during the analysis of environmental data. The discussion of the data-quality measures is followed by an example of their application to a monitoring program in the Big Thompson River watershed of northern Colorado.

User-generated quality standards for youth mental health in primary care: a participatory research design using mixed methods

PubMed Central

Graham, Tanya; Rose, Diana; Murray, Joanna; Ashworth, Mark; Tylee, André

2014-01-01

Objectives To develop user-generated quality standards for young people with mental health problems in primary care using a participatory research model. Methods 50 young people aged 16–25 from community settings and primary care participated in focus groups and interviews about their views and experiences of seeking help for mental health problems in primary care, cofacilitated by young service users and repeated to ensure respondent validation. A second group of young people also aged 16–25 who had sought help for any mental health problem from primary care or secondary care within the last 5 years were trained as focus groups cofacilitators (n=12) developed the quality standards from the qualitative data and participated in four nominal groups (n=28). Results 46 quality standards were developed and ranked by young service users. Agreement was defined as 100% of scores within a two-point region. Group consensus existed for 16 quality standards representing the following aspects of primary care: better advertising and information (three); improved competence through mental health training and skill mix within the practice (two); alternatives to medication (three); improved referral protocol (three); and specific questions and reassurances (five). Alternatives to medication and specific questions and reassurances are aspects of quality which have not been previously reported. Conclusions We have demonstrated the feasibility of using participatory research methods in order to develop user-generated quality standards. The development of patient-generated quality standards may offer a more formal method of incorporating the views of service users into quality improvement initiatives. This method can be adapted for generating quality standards applicable to other patient groups. PMID:24920648

Beam uniformity of flat top lasers

NASA Astrophysics Data System (ADS)

Chang, Chao; Cramer, Larry; Danielson, Don; Norby, James

2015-03-01

Many beams that output from standard commercial lasers are multi-mode, with each mode having a different shape and width. They show an overall non-homogeneous energy distribution across the spot size. There may be satellite structures, halos and other deviations from beam uniformity. However, many scientific, industrial and medical applications require flat top spatial energy distribution, high uniformity in the plateau region, and complete absence of hot spots. Reliable standard methods for the evaluation of beam quality are of great importance. Standard methods are required for correct characterization of the laser for its intended application and for tight quality control in laser manufacturing. The International Organization for Standardization (ISO) has published standard procedures and definitions for this purpose. These procedures have not been widely adopted by commercial laser manufacturers. This is due to the fact that they are unreliable because an unrepresentative single-pixel value can seriously distort the result. We hereby propose a metric of beam uniformity, a way of beam profile visualization, procedures to automatically detect hot spots and beam structures, and application examples in our high energy laser production.

40 CFR 121.1 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-07-01

... certify compliance with applicable water quality standards. If an interstate agency has sole authority to... agency shall be the certifying agency. Where water quality standards have been promulgated by the... Control Act, 33 U.S.C. 1151 et seq. (g) Water quality standards means standards established pursuant to...

40 CFR 121.1 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... certify compliance with applicable water quality standards. If an interstate agency has sole authority to... agency shall be the certifying agency. Where water quality standards have been promulgated by the... Control Act, 33 U.S.C. 1151 et seq. (g) Water quality standards means standards established pursuant to...

The quest for quality blood banking program in the new millennium the American way.

PubMed

Kim, Dae Un

2002-08-01

For an industry to succeed and satisfy its customers, "QUALITY" must be a primary goal. Quality has been central to blood banking from its inception, with the evolution of a Quality Program since the opening of the first blood bank in U.S. at the Cook County Hospital in 1937. Over the ensuing decades, continuous scientific progress in blood preservation, filters, viral and blood group testing, crossmatching, automation, and computerization including bar coding, etc. has contributed to the quality and safety of the blood products and transfusion service. However, with the advent of the AIDS era, an increasingly sensitized and informed public is continuously demanding that the highest level of quality be achieved and maintained in all processes involved in providing all blood products. The Food and Drug Administration (FDA) introduced the concept of a "zero risk blood supply" as the industry goal. Furthermore, the cost containment and resource-constrained environment have changed the complexity of the quality practice. Both regulatory agencies such as the FDA, the Health Care Financing Administration [HCFA, which was recently renamed as the Centers for Medicare and Medicaid Services (CMS) in July, 2001], and the State Department of Health, and accrediting agencies, such as the American Association of Blood Banks (AABB), the College of American Pathologists (CAP), and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), require blood banks and transfusion services to establish and follow a Quality Control and Quality Assurance Program for their licensing, certification and accreditation. Every laboratory has to comply with the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) quality requirements being implemented by the CMS. The FDA guidelines assist facilities in compliance with Current Good Manufacturing Practices (cGMP). The AABB's Quality System Essentials (QSE) are based on these specifications and provide additional guidance in implementing practices that assure quality and compliance with cGMP. AABB and CAP are granted "deemed status" as accrediting organizations under the CLIA '88 program by CMS, as well as JCAHO and some states. The International Standards Organization (ISO) has established international standards in most fields. The U.S. is represented in ISO by the American National Standards Institute (ANSI), and the National Committee for Clinical Laboratory Standards (NCCLS), as a global organization headquartered in the U.S., is a member of ANSI. The FDA and the AABB had begun incorporating many ISO principles into their own regulations and standards. The AABB's 10 QSEs are rooted in the 20 clauses of ISO 9000 series and compatible with their standards. In a Maslow-type model quality hierarchy by Tsiakals, so far the bottom three of the five progressive levels, Quality Control for method control, Quality Assurance for process control, and Quality System for system control have been implemented just to meet the regulatory and accrediting requirements. The next higher level, Quality Management for financial control, and the ultimate highest level, Total Quality Management for strategic control, should be our quest in this new millennium, and with the help of the AABB, ISO, FDA and all other organizations, we will achieve it. We should change our approach to quality issues from detection to prevention. We should improve the quality in transfusion practice itself by effective utilization of blood as a therapeutic resource with clear indication, maximum surgical blood order schedule, alternative transfusion such as autologous transfusion, hemodilution, and intra/post-operative blood salvage, surgical hemostasis, pharmacological hemostasis, and synthetic erythropoietin. Most importantly, implementation of the Quality Program should be something that we want to do rather than simply a burden that we have to do. A well-managed Quality Program is an effective and cost-efficient operation for the blood banks and transfusion services, and will enable us to better serve the patients for whom we exist.

Quality evaluation and pattern recognition analyses of marker compounds from five medicinal drugs of Rutaceae family by HPLC/PDA.

PubMed

Zhao, Bing Tian; Kim, Eun Jung; Son, Kun Ho; Son, Jong Keun; Min, Byung Sun; Woo, Mi Hee

2015-08-01

To establish a standard of quality control and to identify different origins for the Rutaceae family [Citri Unshiu Peel (CU), Citri Unshiu Immature Peel (CI), Ponciri Immature Fructus (PI), Aurantii Immature Fructus (AI), and Aurantii Fructus (AU)], 13 standards including rutin (1), narirutin (2), naringin (3), hesperidin (4), neohesperidin (5), neoponcirin (6), poncirin (7), naringenin (8), isosinensetin (9), sinensetin (10), nobiletin (11), heptamethoxyflavone (12), and tangeretin (13) were determined by high performance liquid chromatography (HPLC)/photo-diode array (PDA) analysis. A YMC ODS C18 (250 × 4.6 mm, 5 µm) column was used and the ratio of mobile phases of water (A) and acetonitrile (B) delivered to the column for gradient elution was applied. This method was fully validated with respect to linearity, accuracy, precision, stability, and robustness. The HPLC/PDA method was applied successfully to quantify 13 major compounds in the extracts of CU, CI, PI, AI, and AU. The pattern recognition analysis combined with LC chromatographic data was performed by repeated analysis of 27 reference samples in the above five Rutaceae oriental medicinal drugs. The established HPLC method was rapid and reliable for quantitative analysis and quality control of multiple components in five Rutaceae species with different origins.

High performance liquid chromatography used for quality control of Achyranthis Radix.

PubMed

Zhao, Bing Tian; Jeong, Su Yang; Moon, Dong Cheul; Son, Kun Ho; Son, Jong Keun; Woo, Mi Hee

2012-08-01

To establish a standard of quality control and to identify reliable Achyranthis Radix, three phytoecdysones including ecdysterone (1), 25R-inokosterone (2) and 25S-inokosterone (3) were determined by quantitative HPLC/UV analysis. Three phytoecdysones were separated with an YMC J'sphere ODS C(18) column (250 mm × 4.6 mm, 4 μm) by isocratic elution using 0.1% formic acid in water and acetonitrile (85:15, v/v%) as the mobile phase. The flow rate was 1.0 mL/min and the UV detector wavelength was set at 245 nm. The standards were quantified by HPLC/UV from Achyranthes bidentata Blume and Achyranthes japonica Nakai, as well as Cyathula capitata Moq. and Cyathula officinalis Kuan, which are of a different genus but are comparative herbs. The method was successfully used in the analysis of Achyranthis Radix of different geographical origin or genera with relatively simple conditions and procedures, and the assay results were satisfactory for linearity, recovery, precision, accuracy, stability and robustness. The HPLC analytical method for pattern recognition analysis was validated by repeated analysis of eighteen A. bidentata Blume samples and ten A. japonica Nakai samples. The results indicate that the established HPLC/UV method is suitable for quantitation and pattern recognition analyses for quality evaluation of Achyranthis Radix.

40 CFR 428.95 - Standards of performance for new sources.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Mechanical Reclaimed Rubber Subcategory § 428.95 Standards of performance for new sources. (a) The following standards of performance establish the quantity or quality of pollutants or pollutant properties, controlled... or quality of pollutants or pollutant properties, controlled by this section and attributable to pan...

Automation and Intensity Modulated Radiation Therapy for Individualized High-Quality Tangent Breast Treatment Plans

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

Purdie, Thomas G., E-mail: Tom.Purdie@rmp.uhn.on.ca; Department of Radiation Oncology, University of Toronto, Toronto, Ontario; Techna Institute, University Health Network, Toronto, Ontario

Purpose: To demonstrate the large-scale clinical implementation and performance of an automated treatment planning methodology for tangential breast intensity modulated radiation therapy (IMRT). Methods and Materials: Automated planning was used to prospectively plan tangential breast IMRT treatment for 1661 patients between June 2009 and November 2012. The automated planning method emulates the manual steps performed by the user during treatment planning, including anatomical segmentation, beam placement, optimization, dose calculation, and plan documentation. The user specifies clinical requirements of the plan to be generated through a user interface embedded in the planning system. The automated method uses heuristic algorithms to definemore » and simplify the technical aspects of the treatment planning process. Results: Automated planning was used in 1661 of 1708 patients receiving tangential breast IMRT during the time interval studied. Therefore, automated planning was applicable in greater than 97% of cases. The time for treatment planning using the automated process is routinely 5 to 6 minutes on standard commercially available planning hardware. We have shown a consistent reduction in plan rejections from plan reviews through the standard quality control process or weekly quality review multidisciplinary breast rounds as we have automated the planning process for tangential breast IMRT. Clinical plan acceptance increased from 97.3% using our previous semiautomated inverse method to 98.9% using the fully automated method. Conclusions: Automation has become the routine standard method for treatment planning of tangential breast IMRT at our institution and is clinically feasible on a large scale. The method has wide clinical applicability and can add tremendous efficiency, standardization, and quality to the current treatment planning process. The use of automated methods can allow centers to more rapidly adopt IMRT and enhance access to the documented improvements in care for breast cancer patients, using technologies that are widely available and already in clinical use.« less

Improved statistical method for temperature and salinity quality control

NASA Astrophysics Data System (ADS)

Gourrion, Jérôme; Szekely, Tanguy

2017-04-01

Climate research and Ocean monitoring benefit from the continuous development of global in-situ hydrographic networks in the last decades. Apart from the increasing volume of observations available on a large range of temporal and spatial scales, a critical aspect concerns the ability to constantly improve the quality of the datasets. In the context of the Coriolis Dataset for ReAnalysis (CORA) version 4.2, a new quality control method based on a local comparison to historical extreme values ever observed is developed, implemented and validated. Temperature, salinity and potential density validity intervals are directly estimated from minimum and maximum values from an historical reference dataset, rather than from traditional mean and standard deviation estimates. Such an approach avoids strong statistical assumptions on the data distributions such as unimodality, absence of skewness and spatially homogeneous kurtosis. As a new feature, it also allows addressing simultaneously the two main objectives of an automatic quality control strategy, i.e. maximizing the number of good detections while minimizing the number of false alarms. The reference dataset is presently built from the fusion of 1) all ARGO profiles up to late 2015, 2) 3 historical CTD datasets and 3) the Sea Mammals CTD profiles from the MEOP database. All datasets are extensively and manually quality controlled. In this communication, the latest method validation results are also presented. The method has already been implemented in the latest version of the delayed-time CMEMS in-situ dataset and will be deployed soon in the equivalent near-real time products.

Improved Statistical Method For Hydrographic Climatic Records Quality Control

NASA Astrophysics Data System (ADS)

Gourrion, J.; Szekely, T.

2016-02-01

Climate research benefits from the continuous development of global in-situ hydrographic networks in the last decades. Apart from the increasing volume of observations available on a large range of temporal and spatial scales, a critical aspect concerns the ability to constantly improve the quality of the datasets. In the context of the Coriolis Dataset for ReAnalysis (CORA) version 4.2, a new quality control method based on a local comparison to historical extreme values ever observed is developed, implemented and validated. Temperature, salinity and potential density validity intervals are directly estimated from minimum and maximum values from an historical reference dataset, rather than from traditional mean and standard deviation estimates. Such an approach avoids strong statistical assumptions on the data distributions such as unimodality, absence of skewness and spatially homogeneous kurtosis. As a new feature, it also allows addressing simultaneously the two main objectives of a quality control strategy, i.e. maximizing the number of good detections while minimizing the number of false alarms. The reference dataset is presently built from the fusion of 1) all ARGO profiles up to early 2014, 2) 3 historical CTD datasets and 3) the Sea Mammals CTD profiles from the MEOP database. All datasets are extensively and manually quality controlled. In this communication, the latest method validation results are also presented. The method has been implemented in the latest version of the CORA dataset and will benefit to the next version of the Copernicus CMEMS dataset.

Distributed sensor architecture for intelligent control that supports quality of control and quality of service.

PubMed

Poza-Lujan, Jose-Luis; Posadas-Yagüe, Juan-Luis; Simó-Ten, José-Enrique; Simarro, Raúl; Benet, Ginés

2015-02-25

This paper is part of a study of intelligent architectures for distributed control and communications systems. The study focuses on optimizing control systems by evaluating the performance of middleware through quality of service (QoS) parameters and the optimization of control using Quality of Control (QoC) parameters. The main aim of this work is to study, design, develop, and evaluate a distributed control architecture based on the Data-Distribution Service for Real-Time Systems (DDS) communication standard as proposed by the Object Management Group (OMG). As a result of the study, an architecture called Frame-Sensor-Adapter to Control (FSACtrl) has been developed. FSACtrl provides a model to implement an intelligent distributed Event-Based Control (EBC) system with support to measure QoS and QoC parameters. The novelty consists of using, simultaneously, the measured QoS and QoC parameters to make decisions about the control action with a new method called Event Based Quality Integral Cycle. To validate the architecture, the first five Braitenberg vehicles have been implemented using the FSACtrl architecture. The experimental outcomes, demonstrate the convenience of using jointly QoS and QoC parameters in distributed control systems.

Distributed Sensor Architecture for Intelligent Control that Supports Quality of Control and Quality of Service

PubMed Central

Poza-Lujan, Jose-Luis; Posadas-Yagüe, Juan-Luis; Simó-Ten, José-Enrique; Simarro, Raúl; Benet, Ginés

2015-01-01

This paper is part of a study of intelligent architectures for distributed control and communications systems. The study focuses on optimizing control systems by evaluating the performance of middleware through quality of service (QoS) parameters and the optimization of control using Quality of Control (QoC) parameters. The main aim of this work is to study, design, develop, and evaluate a distributed control architecture based on the Data-Distribution Service for Real-Time Systems (DDS) communication standard as proposed by the Object Management Group (OMG). As a result of the study, an architecture called Frame-Sensor-Adapter to Control (FSACtrl) has been developed. FSACtrl provides a model to implement an intelligent distributed Event-Based Control (EBC) system with support to measure QoS and QoC parameters. The novelty consists of using, simultaneously, the measured QoS and QoC parameters to make decisions about the control action with a new method called Event Based Quality Integral Cycle. To validate the architecture, the first five Braitenberg vehicles have been implemented using the FSACtrl architecture. The experimental outcomes, demonstrate the convenience of using jointly QoS and QoC parameters in distributed control systems. PMID:25723145

Performing skin microbiome research: A method to the madness

PubMed Central

Kong, Heidi H.; Andersson, Björn; Clavel, Thomas; Common, John E.; Jackson, Scott A.; Olson, Nathan D.; Segre, Julia A.; Traidl-Hoffmann, Claudia

2017-01-01

Growing interest in microbial contributions to human health and disease has increasingly led investigators to examine the microbiome in both healthy skin and cutaneous disorders, including acne, psoriasis and atopic dermatitis. The need for common language, effective study design, and validated methods are critical for high-quality, standardized research. Features, unique to skin, pose particular challenges when conducting microbiome research. This review discusses microbiome research standards and highlights important factors to consider, including clinical study design, skin sampling, sample processing, DNA sequencing, control inclusion, and data analysis. PMID:28063650

Integrated and global pseudotargeted metabolomics strategy applied to screening for quality control markers of Citrus TCMs.

PubMed

Shu, Yisong; Liu, Zhenli; Zhao, Siyu; Song, Zhiqian; He, Dan; Wang, Menglei; Zeng, Honglian; Lu, Cheng; Lu, Aiping; Liu, Yuanyan

2017-08-01

Traditional Chinese medicine (TCM) exerts its therapeutic effect in a holistic fashion with the synergistic function of multiple characteristic constituents. The holism philosophy of TCM is coincident with global and systematic theories of metabolomics. The proposed pseudotargeted metabolomics methodologies were employed for the establishment of reliable quality control markers for use in the screening strategy of TCMs. Pseudotargeted metabolomics integrates the advantages of both targeted and untargeted methods. In the present study, targeted metabolomics equipped with the gold standard RRLC-QqQ-MS method was employed for in vivo quantitative plasma pharmacochemistry study of characteristic prototypic constituents. Meanwhile, untargeted metabolomics using UHPLC-QE Orbitrap HRMS with better specificity and selectivity was employed for identification of untargeted metabolites in the complex plasma matrix. In all, 32 prototypic metabolites were quantitatively determined, and 66 biotransformed metabolites were convincingly identified after being orally administered with standard extracts of four labeled Citrus TCMs. The global absorption and metabolism process of complex TCMs was depicted in a systematic manner.

[The establishment and application of internal quality control system for real-time quantitative PCR detection of BCR-ABL (P210) transcript levels].

PubMed

Zhong, C Q; He, N; Hua, M Q; Wei, X D; Ma, D X; Ji, C Y

2016-09-14

Objective: To set internal quality control system of BCR-ABL (P210) transcript levels for real-time quantitative PCR (RQ-PCR). Methods: Using K562 cells and HL-60 cells, we prepared high- and low-level BCR-ABL internal quality control substance. The BCR-ABL (P210) transcript levels of internal quality control substance have been determined for 184 times together with clinical samples from August 2013 to October 2015. The slope rate, intercept and correlation coefficient of standard curve were calculated according to different reagent lots (lots number 20130303, 20131212, 20140411 and 20150327 are called R1、R2、R3 and R4 for short respectively), and the detection results of quality control substance were calculated according to different reagent lots and quality control substance lots (lots number 20130725, 20140611 are called Q1、Q2 for short respectively). Then the results were analyzed by Levey-Jennings quality control chart combined with Westgard multi-rules theory. Results: ①We analyzed the slope rate and intercept of standard curve. Fifty-three times of the R1 reagent detection, 80 times of the R3 reagent detection and 14 times of the R4 reagent detection were all under control. For 37 times detection of R2 reagent, the slope rate was out of control for 6 times. It was lower than x - s for the 2-8 tests and upper the average for the 12-37 tests. The intercept was out of control for 9 times, upper the x + s for the 1-8 tests and lower the average for the 12-37 tests. ② According to the detection results of quality control substance, for Q1 quality control substance, 49 tests by R1 reagent were under control, and 1 out of 23 tests by R2 reagent was out of control. For Q2 quality control substance, 14 tests by R2 reagent detection, 72 tests by R3 reagent detection and 14 tests by R4 reagent were all under control. Conclusion: The preparation of high- and low-level quality control substance using K562 and HL-60 cells was convenient and the detection results were reliable and stable. The application of quality control substance combined with slope rate and intercept in the internal quality control may contribute to quality assurance for quantitative detection of BCR-ABL (P210) transcript levels.

pcr: an R package for quality assessment, analysis and testing of qPCR data

PubMed Central

Ahmed, Mahmoud

2018-01-01

Background Real-time quantitative PCR (qPCR) is a broadly used technique in the biomedical research. Currently, few different analysis models are used to determine the quality of data and to quantify the mRNA level across the experimental conditions. Methods We developed an R package to implement methods for quality assessment, analysis and testing qPCR data for statistical significance. Double Delta CT and standard curve models were implemented to quantify the relative expression of target genes from CT in standard qPCR control-group experiments. In addition, calculation of amplification efficiency and curves from serial dilution qPCR experiments are used to assess the quality of the data. Finally, two-group testing and linear models were used to test for significance of the difference in expression control groups and conditions of interest. Results Using two datasets from qPCR experiments, we applied different quality assessment, analysis and statistical testing in the pcr package and compared the results to the original published articles. The final relative expression values from the different models, as well as the intermediary outputs, were checked against the expected results in the original papers and were found to be accurate and reliable. Conclusion The pcr package provides an intuitive and unified interface for its main functions to allow biologist to perform all necessary steps of qPCR analysis and produce graphs in a uniform way. PMID:29576953

Comparative evaluation of different cultivars of Flos Chrysanthemi by an anti-inflammatory-based NF-κB reporter gene assay coupled to UPLC-Q/TOF MS with PCA and ANN.

PubMed

Han, Yanqi; Zhou, Mengge; Wang, Liqiang; Ying, Xuhui; Peng, Jiamin; Jiang, Min; Bai, Gang; Luo, Guoan

2015-11-04

Flos Chrysanthemi (FC), a commonly used traditional Chinese medicine, has five major cultivars ("Boju", "Chuju", "Gongju", "Hangbaiju" and "Huaiju") from different sources. However, the active constituents of these cultivars have not been studied or characterized with respect to their bioactivity, which is a serious problem when considering quality and safety. To evaluate the differences among the five cultivars of FC, and to establish a method for the standardization and quality control of FC related to its bioactivity. In this study, the different ingredients in five cultivars of FC were identified by UPLC-Q/TOF and PCA, and the anti-inflammatory ingredients of FC were predicted and screened by artificial neural network (ANN) and an NF-κB luciferase reporter gene assay system. Using this comprehensive method, we successfully screened the anti-inflammatory markers of different cultivars of FC. Nineteen marker ingredients were confirmed to contribute strongly to the cluster, and eleven compounds in the five cultivars of FC were found to exert potential anti-inflammatory effects. Among these compounds, the NF-κB inhibitor activity of apigenin-7-O-6″-malonyl-glucoside, luteolin-7-O-rutinoside, quercetin-7-O-galactoside, quercetin-3-O-glucoside, apigenin-7-O-rutinoside and apigenin-7-O-glucoside were first reported here. Chlorogenic acid, luteolin-7-O-glucoside, 3,5-dicaffeoylquinic acid and luteolin were confirmed to be the most important anti-inflammatory marker ingredients useful for the quality control of FC. The proposed efficient and systematic method is helpful for the standardization and quality control of FC. Moreover, this comprehensive strategy may prove to be a powerful technique for the rapid establishment of quality control procedures related to bioactivity for other herbal samples and foods. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Microbiological water methods: quality control measures for Federal Clean Water Act and Safe Drinking Water Act regulatory compliance.

PubMed

Root, Patsy; Hunt, Margo; Fjeld, Karla; Kundrat, Laurie

2014-01-01

Quality assurance (QA) and quality control (QC) data are required in order to have confidence in the results from analytical tests and the equipment used to produce those results. Some AOAC water methods include specific QA/QC procedures, frequencies, and acceptance criteria, but these are considered to be the minimum controls needed to perform a microbiological method successfully. Some regulatory programs, such as those at Code of Federal Regulations (CFR), Title 40, Part 136.7 for chemistry methods, require additional QA/QC measures beyond those listed in the method, which can also apply to microbiological methods. Essential QA/QC measures include sterility checks, reagent specificity and sensitivity checks, assessment of each analyst's capabilities, analysis of blind check samples, and evaluation of the presence of laboratory contamination and instrument calibration and checks. The details of these procedures, their performance frequency, and expected results are set out in this report as they apply to microbiological methods. The specific regulatory requirements of CFR Title 40 Part 136.7 for the Clean Water Act, the laboratory certification requirements of CFR Title 40 Part 141 for the Safe Drinking Water Act, and the International Organization for Standardization 17025 accreditation requirements under The NELAC Institute are also discussed.

National Survey on Internal Quality Control for HbA(1c) Analytical Instruments in 331 Hospital Laboratories of China.

PubMed

Zeng, Rong; Wang, Wei; Zhao, Haijian; Fei, Yang; Wang, Zhiguo

2015-01-01

The narrow gap of HbA1 value of mass fraction between "normal" (< 6.0%) and "diabetes" (≥ 6.5%) necessitates tight control of inter-assay standardization, assay precision, and trueness. This survey was initiated to obtain knowledge of the current situation of internal quality control (IQC) practice for HbA(1c) in China and find out the most appropriate quality specifications. Data of IQC for HbA(1c) in 331 institutions participating in the national proficiency testing (PT) programs in China were evaluated using four levels of quality specifications, and the percentages of laboratories meeting the quality requirement were calculated to find out the most appropriate quality specifications for control materials of HbA(1c) in China. The IQC data varied vastly among 331 clinical laboratories in China. The measurement of control materials covered a wide range from 4.52% to 12.24% (inter-quartile range) and there were significant differences among the CVs of different methods, including LPLC, CE-HPLC, AC-HPLC, immunoturbidimetry, and others. Among the four main methods, CE-HPLC and AC-HPLC achieved a better precision. As we can see, the performance of laboratories for HbA(1c) has yet to be improved. Clinical laboratories in China should improve their performance with a stricter imprecision criteria.

NHEXAS PHASE I ARIZONA STUDY--STANDARD OPERATING PROCEDURE--COMPENDIUM OF METHODS FOR ANALYSIS OF TRACE METALS AND PESTICIDES IN DIETARY SAMPLES USING TOTAL DIET STUDY PROCEDURES (FDA-COMPENDIUM)

EPA Science Inventory

This compendium contains seven SOPs developed by Food and Drug Administration (FDA) laboratories for methods of analyzing trace metals in dietary samples collected using Total Diet study procedures. The SOPs include the following: (1) Quality Control for Analysis of NHEXAS Food o...

Issues of Teaching Metrology in Higher Education Institutions of Civil Engineering in Russia

ERIC Educational Resources Information Center

Pukharenko, Yurii Vladimirovich; Norin, Veniamin Aleksandrovich

2017-01-01

The work analyses the training process condition in teaching the discipline "Metrology, Standardization, Certification and Quality Control." It proves that the current educational standard regarding the instruction of the discipline "Metrology, Standardization, Certification and Quality Control" does not meet the needs of the…

The Surface Ocean CO2 Atlas: Stewarding Underway Carbon Data from Collection to Archival

NASA Astrophysics Data System (ADS)

O'Brien, K.; Smith, K. M.; Pfeil, B.; Landa, C.; Bakker, D. C. E.; Olsen, A.; Jones, S.; Shrestha, B.; Kozyr, A.; Manke, A. B.; Schweitzer, R.; Burger, E. F.

2016-02-01

The Surface Ocean CO2 Atlas (SOCAT, www.socat.info) is a quality controlled, global surface ocean carbon dioxide (CO2) data set gathered on research vessels, SOOP and buoys. To the degree feasible SOCAT is comprehensive; it draws together and applies uniform QC procedures to all such observations made across the international community. The first version of SOCAT (version 1.5) was publicly released September 2011(Bakker et al., 2011) with 6.3 million observations. This was followed by the release of SOCAT version 2, expanded to over 10 million observations, in June 2013 (Bakker et al., 2013). Most recently, in September 2015 SOCAT version 3 was released containing over 14 millions observations spanning almost 60 years! The process of assembling, QC'ing and publishing V1.5 and V2 of SOCAT required an unsustainable level of manual effort. To ease the burden on data managers and data providers, the SOCAT community agreed to embark an automated data ingestion process which would create a streamlined workflow to improve data stewardship from ingestion to quality control and from publishing to archival. To that end, for version 3 and beyond, the SOCAT automation team created a framework which was based upon standards and conventions, yet at the same time allows scientists to work in the data formats they felt most comfortable with (ie, csv files). This automated workflow provides several advantages: 1) data ingestion into uniform and standards-based file formats; 2) ease of data integration into standard quality control system; 3) data ingestion and quality control can be performed in parallel; 4) provides uniform method of archiving carbon data and generation of digital object identifiers (DOI).In this presentation, we will discuss and demonstrate the SOCAT data ingestion dashboard and the quality control system. We will also discuss the standards, conventions, and tools that were leveraged to create a workflow that allows scientists to work in their own formats, yet provides a framework for creating high quality data products on an annual basis, while meeting or exceeding data requirements for access, documentation and archival.

Prototyping and implementing flight qualifiable semicustom CMOS P-well bulk integrated circuits in the JPL environment

NASA Technical Reports Server (NTRS)

Olson, E. M.

1986-01-01

Presently, there are many difficulties associated with implementing application specific custom or semi-custom (standard cell based) integrated circuits (ICs) into JPL flight projects. One of the primary difficulties is developing prototype semi-custom integrated circuits for use and evaluation in engineering prototype flight hardware. The prototype semi-custom ICs must be extremely cost-effective and yet still representative of flight qualifiable versions of the design. A second difficulty is encountered in the transport of the design from engineering prototype quality to flight quality. Normally, flight quality integrated circuits have stringent quality standards, must be radiation resistant and should consume minimal power. It is often not necessary or cost effective, however, to impose such stringent quality standards on engineering models developed for systems analysis in controlled lab environments. This article presents work originally initiated for ground based applications that also addresses these two problems. Furthermore, this article suggests a method that has been shown successful in prototyping flight quality semi-custom ICs through the Metal Oxide Semiconductor Implementation Service (MOSIS) program run by the University of Southern California's Information Sciences Institute. The method has been used successfully to design and fabricate through the MOSIS three different semi-custom prototype CMOS p-well chips. The three designs make use of the work presented and were designed consistent with design techniques and structures that are flight qualifiable, allowing one hour transfer of the design from engineering model status to flight qualifiable foundry-ready status through methods outlined in this article.

Automation and intensity modulated radiation therapy for individualized high-quality tangent breast treatment plans.

PubMed

Purdie, Thomas G; Dinniwell, Robert E; Fyles, Anthony; Sharpe, Michael B

2014-11-01

To demonstrate the large-scale clinical implementation and performance of an automated treatment planning methodology for tangential breast intensity modulated radiation therapy (IMRT). Automated planning was used to prospectively plan tangential breast IMRT treatment for 1661 patients between June 2009 and November 2012. The automated planning method emulates the manual steps performed by the user during treatment planning, including anatomical segmentation, beam placement, optimization, dose calculation, and plan documentation. The user specifies clinical requirements of the plan to be generated through a user interface embedded in the planning system. The automated method uses heuristic algorithms to define and simplify the technical aspects of the treatment planning process. Automated planning was used in 1661 of 1708 patients receiving tangential breast IMRT during the time interval studied. Therefore, automated planning was applicable in greater than 97% of cases. The time for treatment planning using the automated process is routinely 5 to 6 minutes on standard commercially available planning hardware. We have shown a consistent reduction in plan rejections from plan reviews through the standard quality control process or weekly quality review multidisciplinary breast rounds as we have automated the planning process for tangential breast IMRT. Clinical plan acceptance increased from 97.3% using our previous semiautomated inverse method to 98.9% using the fully automated method. Automation has become the routine standard method for treatment planning of tangential breast IMRT at our institution and is clinically feasible on a large scale. The method has wide clinical applicability and can add tremendous efficiency, standardization, and quality to the current treatment planning process. The use of automated methods can allow centers to more rapidly adopt IMRT and enhance access to the documented improvements in care for breast cancer patients, using technologies that are widely available and already in clinical use. Copyright © 2014 Elsevier Inc. All rights reserved.

Assessment of a novel multi-array normalization method based on spike-in control probes suitable for microRNA datasets with global decreases in expression.

PubMed

Sewer, Alain; Gubian, Sylvain; Kogel, Ulrike; Veljkovic, Emilija; Han, Wanjiang; Hengstermann, Arnd; Peitsch, Manuel C; Hoeng, Julia

2014-05-17

High-quality expression data are required to investigate the biological effects of microRNAs (miRNAs). The goal of this study was, first, to assess the quality of miRNA expression data based on microarray technologies and, second, to consolidate it by applying a novel normalization method. Indeed, because of significant differences in platform designs, miRNA raw data cannot be normalized blindly with standard methods developed for gene expression. This fundamental observation motivated the development of a novel multi-array normalization method based on controllable assumptions, which uses the spike-in control probes to adjust the measured intensities across arrays. Raw expression data were obtained with the Exiqon dual-channel miRCURY LNA™ platform in the "common reference design" and processed as "pseudo-single-channel". They were used to apply several quality metrics based on the coefficient of variation and to test the novel spike-in controls based normalization method. Most of the considerations presented here could be applied to raw data obtained with other platforms. To assess the normalization method, it was compared with 13 other available approaches from both data quality and biological outcome perspectives. The results showed that the novel multi-array normalization method reduced the data variability in the most consistent way. Further, the reliability of the obtained differential expression values was confirmed based on a quantitative reverse transcription-polymerase chain reaction experiment performed for a subset of miRNAs. The results reported here support the applicability of the novel normalization method, in particular to datasets that display global decreases in miRNA expression similarly to the cigarette smoke-exposed mouse lung dataset considered in this study. Quality metrics to assess between-array variability were used to confirm that the novel spike-in controls based normalization method provided high-quality miRNA expression data suitable for reliable downstream analysis. The multi-array miRNA raw data normalization method was implemented in an R software package called ExiMiR and deposited in the Bioconductor repository.

Assessment of a novel multi-array normalization method based on spike-in control probes suitable for microRNA datasets with global decreases in expression

PubMed Central

2014-01-01

Background High-quality expression data are required to investigate the biological effects of microRNAs (miRNAs). The goal of this study was, first, to assess the quality of miRNA expression data based on microarray technologies and, second, to consolidate it by applying a novel normalization method. Indeed, because of significant differences in platform designs, miRNA raw data cannot be normalized blindly with standard methods developed for gene expression. This fundamental observation motivated the development of a novel multi-array normalization method based on controllable assumptions, which uses the spike-in control probes to adjust the measured intensities across arrays. Results Raw expression data were obtained with the Exiqon dual-channel miRCURY LNA™ platform in the “common reference design” and processed as “pseudo-single-channel”. They were used to apply several quality metrics based on the coefficient of variation and to test the novel spike-in controls based normalization method. Most of the considerations presented here could be applied to raw data obtained with other platforms. To assess the normalization method, it was compared with 13 other available approaches from both data quality and biological outcome perspectives. The results showed that the novel multi-array normalization method reduced the data variability in the most consistent way. Further, the reliability of the obtained differential expression values was confirmed based on a quantitative reverse transcription–polymerase chain reaction experiment performed for a subset of miRNAs. The results reported here support the applicability of the novel normalization method, in particular to datasets that display global decreases in miRNA expression similarly to the cigarette smoke-exposed mouse lung dataset considered in this study. Conclusions Quality metrics to assess between-array variability were used to confirm that the novel spike-in controls based normalization method provided high-quality miRNA expression data suitable for reliable downstream analysis. The multi-array miRNA raw data normalization method was implemented in an R software package called ExiMiR and deposited in the Bioconductor repository. PMID:24886675

Swedish snus and the GothiaTek® standard

PubMed Central

2011-01-01

Some smokeless tobacco products, such as Swedish snus, are today considered to be associated with substantially fewer health hazards than cigarettes. This risk differential has contributed to the scientific debate about the possibilities of harm reduction within the tobacco area. Although current manufacturing methods for snus build on those that were introduced more than a century ago, the low levels of unwanted substances in modern Swedish snus are largely due to improvements in production techniques and selection of raw materials in combination with several programs for quality assurance and quality control. These measures have been successively introduced during the past 30-40 years. In the late 1990s they formed the basis for a voluntary quality standard for Swedish snus named GothiaTek®. In recent years the standard has been accepted by the members of the trade organization European Smokeless Tobacco Council (ESTOC) so it has now evolved into an industrial standard for all smokeless tobacco products in Europe. The initial impetus for the mentioned changes of the production was quality problems related to microbial activity and formation of ammonia and nitrite in the finished products. Other contributing factors were that snus came under the jurisdiction of the Swedish Food Act in 1971, and concerns that emerged in the 1960s and 1970s about health effects of tobacco, and the significance of agrochemical residues and other potential toxicants in food stuffs. This paper summarizes the historical development of the manufacture of Swedish snus, describes the chemical composition of modern snus, and gives the background and rationale for the GothiaTek® standard, including the selection of constituents for which the standard sets limits. The paper also discusses the potential future of this voluntary standard in relation to current discussions about tobacco harm reduction and regulatory science in tobacco control. PMID:21575206

Improving Quality of Care in Primary Health-Care Facilities in Rural Nigeria

PubMed Central

Ugo, Okoli; Ezinne, Eze-Ajoku; Modupe, Oludipe; Nicole, Spieker; Kelechi, Ohiri

2016-01-01

Background: Nigeria has a high population density but a weak health-care system. To improve the quality of care, 3 organizations carried out a quality improvement pilot intervention at the primary health-care level in selected rural areas. Objective: To assess the change in quality of care in primary health-care facilities in rural Nigeria following the provision of technical governance support and to document the successes and challenges encountered. Method: A total of 6 states were selected across the 6 geopolitical zones of the country. However, assessments were carried out in 40 facilities in only 5 states. Selection was based on location, coverage, and minimum services offered. The facilities were divided randomly into 2 groups. The treatment group received quality-of-care assessment, continuous feedback, and improvement support, whereas the control group received quality assessment and no other support. Data were collected using the SafeCare Healthcare Standards and managed on the SafeCare Data Management System—AfriDB. Eight core areas were assessed at baseline and end line, and compliance to quality health-care standards was compared. Result: Outcomes from 40 facilities were accepted and analyzed. Overall scores increased in the treatment facilities compared to the control facilities, with strong evidence of improvement (t = 5.28, P = .0004) and 11% average improvement, but no clear pattern of improvement emerged in the control group. Conclusion: The study demonstrated governance support and active community involvement offered potential for quality improvement in primary health-care facilities. PMID:28462280

Introduction to Food Analysis

NASA Astrophysics Data System (ADS)

Nielsen, S. Suzanne

Investigations in food science and technology, whether by the food industry, governmental agencies, or universities, often require determination of food composition and characteristics. Trends and demands of consumers, the food industry, and national and international regulations challenge food scientists as they work to monitor food composition and to ensure the quality and safety of the food supply. All food products require analysis as part of a quality management program throughout the development process (including raw ingredients), through production, and after a product is in the market. In addition, analysis is done of problem samples and competitor products. The characteristics of foods (i.e., chemical composition, physical properties, sensory properties) are used to answer specific questions for regulatory purposes and typical quality control. The nature of the sample and the specific reason for the analysis commonly dictate the choice of analytical methods. Speed, precision, accuracy, and ruggedness often are key factors in this choice. Validation of the method for the specific food matrix being analyzed is necessary to ensure usefulness of the method. Making an appropriate choice of the analytical technique for a specific application requires a good knowledge of the various techniques (Fig. 1.1). For example, your choice of method to determine the salt content of potato chips would be different if it is for nutrition labeling than for quality control. The success of any analytical method relies on the proper selection and preparation of the food sample, carefully performing the analysis, and doing the appropriate calculations and interpretation of the data. Methods of analysis developed and endorsed by several nonprofit scientific organizations allow for standardized comparisons of results between different laboratories and for evaluation of less standard procedures. Such official methods are critical in the analysis of foods, to ensure that they meet the legal requirements established by governmental agencies. Government regulations and international standards most relevant to the analysis of foods are mentioned here but covered in more detail in Chap. 2, and nutrition labeling regulations in the USA are covered in Chap. 3. Internet addresses for many of the organizations and government agencies discussed are given at the end of this chapter.

Halogenated Peptides as Internal Standards (H-PINS)

PubMed Central

Mirzaei, Hamid; Brusniak, Mi-Youn; Mueller, Lukas N.; Letarte, Simon; Watts, Julian D.; Aebersold, Ruedi

2009-01-01

As the application for quantitative proteomics in the life sciences has grown in recent years, so has the need for more robust and generally applicable methods for quality control and calibration. The reliability of quantitative proteomics is tightly linked to the reproducibility and stability of the analytical platforms, which are typically multicomponent (e.g. sample preparation, multistep separations, and mass spectrometry) with individual components contributing unequally to the overall system reproducibility. Variations in quantitative accuracy are thus inevitable, and quality control and calibration become essential for the assessment of the quality of the analyses themselves. Toward this end, the use of internal standards cannot only assist in the detection and removal of outlier data acquired by an irreproducible system (quality control) but can also be used for detection of changes in instruments for their subsequent performance and calibration. Here we introduce a set of halogenated peptides as internal standards. The peptides are custom designed to have properties suitable for various quality control assessments, data calibration, and normalization processes. The unique isotope distribution of halogenated peptides makes their mass spectral detection easy and unambiguous when spiked into complex peptide mixtures. In addition, they were designed to elute sequentially over an entire aqueous to organic LC gradient and to have m/z values within the commonly scanned mass range (300–1800 Da). In a series of experiments in which these peptides were spiked into an enriched N-glycosite peptide fraction (i.e. from formerly N-glycosylated intact proteins in their deglycosylated form) isolated from human plasma, we show the utility and performance of these halogenated peptides for sample preparation and LC injection quality control as well as for retention time and mass calibration. Further use of the peptides for signal intensity normalization and retention time synchronization for selected reaction monitoring experiments is also demonstrated. PMID:19411281

IMI's teaching design, feedback system and its localization

NASA Astrophysics Data System (ADS)

Wen, Tingting; Zhang, Xuexin

2017-08-01

In Britain, the Institute of the Motor Industry (IMI) sets the National Occupational Standards for all sectors of the automotive industry. The IMI certificate and associated training programs are well recognized for its high quality both in the United Kingdom (UK) and internationally. Using China's first groups studying IMI Level 3 certificate for teachers and Level 2 certificate for students as a sample, we analyzed the seven central aspects in IMI teaching, namely, assessment standard, environment, method, content, procedure, quality control and feedback. We then proposed strategies and guidelines for its localization in China, which would be particularly important for the establishment and expansion of IMI centers.

[Development of whole process quality control and management system of traditional Chinese medicine decoction pieces based on traditional Chinese medicine quality tree].

PubMed

Yu, Wen-Kang; Dong, Ling; Pei, Wen-Xuan; Sun, Zhi-Rong; Dai, Jun-Dong; Wang, Yun

2017-12-01

The whole process quality control and management of traditional Chinese medicine (TCM) decoction pieces is a system engineering, involving the base environment, seeds and seedlings, harvesting, processing and other multiple steps, so the accurate identification of factors in TCM production process that may induce the quality risk, as well as reasonable quality control measures are very important. At present, the concept of quality risk is mainly concentrated in the aspects of management and regulations, etc. There is no comprehensive analysis on possible risks in the quality control process of TCM decoction pieces, or analysis summary of effective quality control schemes. A whole process quality control and management system for TCM decoction pieces based on TCM quality tree was proposed in this study. This system effectively combined the process analysis method of TCM quality tree with the quality risk management, and can help managers to make real-time decisions while realizing the whole process quality control of TCM. By providing personalized web interface, this system can realize user-oriented information feedback, and was convenient for users to predict, evaluate and control the quality of TCM. In the application process, the whole process quality control and management system of the TCM decoction pieces can identify the related quality factors such as base environment, cultivation and pieces processing, extend and modify the existing scientific workflow according to their own production conditions, and provide different enterprises with their own quality systems, to achieve the personalized service. As a new quality management model, this paper can provide reference for improving the quality of Chinese medicine production and quality standardization. Copyright© by the Chinese Pharmaceutical Association.

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.

Implementation of a reference standard and proficiency testing programme by the World Wide Antimalarial Resistance Network (WWARN)

PubMed Central

2010-01-01

Background The Worldwide Antimalarial Resistance Network (WWARN) is a global collaboration to support the objective that anyone affected by malaria receives effective and safe drug treatment. The Pharmacology module aims to inform optimal anti-malarial drug selection. There is an urgent need to define the drug exposure - effect relationship for most anti-malarial drugs. Few anti-malarials have had their therapeutic blood concentration levels defined. One of the main challenges in assessing safety and efficacy data in relation to drug concentrations is the comparability of data generated from different laboratories. To explain differences in anti-malarial pharmacokinetics in studies with different measurement laboratories it is necessary to confirm the accuracy of the assay methods. This requires the establishment of an external quality assurance process to assure results that can be compared. This paper describes this process. Methods The pharmacology module of WWARN has established a quality assurance/quality control (QA/QC) programme consisting of two separate components: 1. A proficiency testing programme where blank human plasma spiked with certified reference material (CRM) in different concentrations is sent out to participating bioanalytical laboratories. 2. A certified reference standard programme where accurately weighed amounts of certified anti-malarial reference standards, metabolites, and internal standards are sent to participating bioanalytical and in vitro laboratories. Conclusion The proficiency testing programme is designed as a cooperative effort to help participating laboratories assess their ability to carry out drug analysis, resolve any potential problem areas and to improve their results - and, in so doing, to improve the quality of anti-malarial pharmacokinetic data published and shared with WWARN. By utilizing the same source of standards for all laboratories, it is possible to minimize bias arising from poor quality reference standards. By providing anti-malarial drug standards from a central point, it is possible to lower the cost of these standards. PMID:21184684

Chemical profiling and quantification of Chinese medicinal formula Huang-Lian-Jie-Du decoction, a systematic quality control strategy using ultra high performance liquid chromatography combined with hybrid quadrupole-orbitrap and triple quadrupole mass spectrometers.

PubMed

Yang, Yang; Wang, Hong-Jie; Yang, Jian; Brantner, Adelheid H; Lower-Nedza, Agnieszka D; Si, Nan; Song, Jian-Fang; Bai, Bing; Zhao, Hai-Yu; Bian, Bao-Lin

2013-12-20

To clarify and quantify the chemical profiling of Huang-Lian-Jie-Du decoction (HLJDD) rapidly, a feasible and accurate strategy was developed by applying high speed LC combined with hybrid quadrupole-orbitrap mass spectrometer (Q-Exactive) and UHPLC-triple quadruple mass spectrometer (UHPLC-QqQ MS). 69 compounds, including iridoids, alkaloids, flavonoids, triterpenoid, monoterpene and phenolic acids, were identified by their characteristic high resolution mass data. Among them, 18 major compounds were unambiguously detected by comparing with reference standards. In the subsequent quantitative analysis, 17 representative compounds, selected as quality control markers, were simultaneously detected in 10 batches of HLJDD samples by UHPLC-QqQ MS. These samples were collected from four different countries (regions). Icariin, swertiamarin and corynoline were employed as internal standards for flavonoids, iridoids and alkaloids respectively. All the analytes were detected within 12min. Polarity switching mode was used in the optimization of multiple reaction monitoring (MRM) conditions. Satisfactory linearity was achieved with wide linear range and fine determination coefficient (r(2)>0.9990). The relative standard deviations (RSD) of inter- and intra-day precisions were less than 5.0%. This method was also validated by repeatability, stability (8h) and recovery, with respective RSDs less than 4.6%, 5.0% and 6.3%. This research established a high sensitive and efficient method for the integrating quality control, including identification and quantification of Chinese medicinal formulas. Copyright © 2013 Elsevier B.V. All rights reserved.

Developing standards for malaria microscopy: external competency assessment for malaria microscopists in the Asia-Pacific

PubMed Central

2012-01-01

Background Malaria diagnosis has received renewed interest in recent years, associated with the increasing accessibility of accurate diagnosis through the introduction of rapid diagnostic tests and new World Health Organization guidelines recommending parasite-based diagnosis prior to anti-malarial therapy. However, light microscopy, established over 100 years ago and frequently considered the reference standard for clinical diagnosis, has been neglected in control programmes and in the malaria literature and evidence suggests field standards are commonly poor. Microscopy remains the most accessible method for parasite quantitation, for drug efficacy monitoring, and as a reference of assessing other diagnostic tools. This mismatch between quality and need highlights the importance of the establishment of reliable standards and procedures for assessing and assuring quality. This paper describes the development, function and impact of a multi-country microscopy external quality assurance network set up for this purpose in Asia. Methods Surveys were used for key informants and past participants for feedback on the quality assurance programme. Competency scores for each country from 14 participating countries were compiled for analyses using paired sample t-tests. In-depth interviews were conducted with key informants including the programme facilitators and national level microscopists. Results External assessments and limited retraining through a formalized programme based on a reference slide bank has demonstrated an increase in standards of competence of senior microscopists over a relatively short period of time, at a potentially sustainable cost. The network involved in the programme now exceeds 14 countries in the Asia-Pacific, and the methods are extended to other regions. Conclusions While the impact on national programmes varies, it has translated in some instances into a strengthening of national microscopy standards and offers a possibility both for supporting revival of national microcopy programmes, and for the development of globally recognized standards of competency needed both for patient management and field research. PMID:23095668

[Construction and operation status of management system of laboratories of schistosomiasis control institutions in Hubei Province].

PubMed

Zhao-Hui, Zheng; Jun, Qin; Li, Chen; Hong, Zhu; Li, Tang; Zu-Wu, Tu; Ming-Xing, Zeng; Qian, Sun; Shun-Xiang, Cai

2016-10-09

To analyze the construction and operation status of management system of laboratories of schistosomiasis control institutions in Hubei Province, so as to provide the reference for the standardized detection and management of schistosomiasis laboratories. According to the laboratory standard of schistosomiasis at provincial, municipal and county levels, the management system construction and operation status of 60 schistosomiasis control institutions was assessed by the acceptance examination method from 2013 to 2015. The management system was already occupied over all the laboratories of schistosomiasis control institutions and was officially running. There were 588 non-conformities and the inconsistency rate was 19.60%. The non-conformity rate of the management system of laboratory quality control was 38.10% (224 cases) and the non-conformity rate of requirements of instrument and equipment was 23.81% (140 cases). The management system has played an important role in the standardized management of schistosomiasis laboratories.

[Application of microscopic spectroscopy in quality control of Niuhuang Qingxin pills].

PubMed

Nie, Li-Xing; Zhang, Ye; Zhang, Nan-Ping; Hu, Xiao-Ru; Kang, Shuai; Hou, Jian-Zhong; Dai, Zhong; Ma, Shuang-Cheng

2016-10-01

Application of microscopic spectroscopy in quality control of Niuhuang Qingxin pills was discussed. First, microscopic characteristics specified by the statutory standard of Niuhuang Qingxin pills were summarized. Then new identification method was established for Dioscoreae Rhizoma, Saigae Tataricae Cornu, Cinnamomi Cortex and Saposhnikoviae Radix. Finally, microscopic spectroscopy was used for test of Dioscoreae Rhizoma's adulterant Dioscoreae Fordii Rhizoma.It was the first time for this technology being applied in adulteration test of Chinese patent medicine.The results showed that Saigae Tataricae Cornu was not detected in 2 batches of Niuhuang Qingxin pills from 1 manufacturer while Dioscoreae Fordii Rhizoma was detected in 3 batches of samples from 2 manufacturers. The proposed methods were accurate, simple, rapid, objective and economic, which offered a more comprehensive approach for quality control of Niuhuang Qingxin pills. It was indicated that conventional technology such as microscopic spectroscopy could play an important role in identification of traditional Chinese medicine whose index ingredient was deficient or tiny. Copyright© by the Chinese Pharmaceutical Association.

MALDI-TOF MS for quality control of high protein content sport supplements.

PubMed

De Ceglie, Cristina; Calvano, Cosima D; Zambonin, Carlo G

2015-06-01

High protein content sport nutritional supplements are found as powder products containing, as ingredients, amino acids and proteins with important nutritional values as milk, soy and egg proteins. An EU Food Supplements Directive (2002) requires that supplements should be safe, both in dosages and in purity. It is important, then, to develop rapid and sensitive methods to be employed for the quality control of these substances. In this work, we apply, for the first time, matrix-assisted laser desorption ionization-mass spectrometry as a fast, reproducible and sensitive method for the quality control of sport nutritional supplements based on proteins. To this aim, several commercial egg- and/or milk-based powder products have been processed by in gel or in solution digestion and analyzed in comparison to pure standard products. This strategy allowed to assess the reliability of the indications on proteins (as caseins, whey proteins and ovalbumin) declared in the label of several sport nutritional supplements. Copyright © 2014 Elsevier Ltd. All rights reserved.

40 CFR 50.12 - National primary and secondary ambient air quality standards for lead.

Code of Federal Regulations, 2013 CFR

2013-07-01

... air quality standards for lead. 50.12 Section 50.12 Protection of Environment ENVIRONMENTAL PROTECTION... National primary and secondary ambient air quality standards for lead. (a) National primary and secondary ambient air quality standards for lead and its compounds, measured as elemental lead by a reference method...

40 CFR 50.12 - National primary and secondary ambient air quality standards for lead.

Code of Federal Regulations, 2012 CFR

2012-07-01

... air quality standards for lead. 50.12 Section 50.12 Protection of Environment ENVIRONMENTAL PROTECTION... National primary and secondary ambient air quality standards for lead. (a) National primary and secondary ambient air quality standards for lead and its compounds, measured as elemental lead by a reference method...

40 CFR 50.12 - National primary and secondary ambient air quality standards for lead.

Code of Federal Regulations, 2011 CFR

2011-07-01

... air quality standards for lead. 50.12 Section 50.12 Protection of Environment ENVIRONMENTAL PROTECTION... National primary and secondary ambient air quality standards for lead. (a) National primary and secondary ambient air quality standards for lead and its compounds, measured as elemental lead by a reference method...

EPA Method 1615. Measurement of Enterovirus and Norovirus ...

EPA Pesticide Factsheets

A standardized method is required when national studies on virus occurrence in environmental and drinking waters utilize multiple analytical laboratories. The U.S Environmental Protection Agency’s (USEPA) Method 1615 was developed with the goal of providing such a standard for measuring Enterovirus and Norovirus in these waters. Virus is concentrated from water using an electropositive filter, eluted from the filter surface with beef extract, and then concentrated further using organic flocculation. Herein we present the protocol from Method 1615 for filter elution, secondary concentration, and measurement of total culturable viruses. A portion of the concentrated eluate from each sample is inoculated onto ten replicate flasks of Buffalo Green Monkey kidney cells. The number of flasks demonstrating cytopathic effects is used to quantify the most probable number (MPN) of infectious units per liter. The method uses a number of quality controls to increase data quality and to reduce interlaboratory and intralaboratory variation. Laboratories must meet defined performance standards. Method 1615 was evaluated by examining virus recovery from reagent-grade and ground waters seeded with Sabin poliovirus type 3. Mean poliovirus recoveries with the total culturable assay were 111% in reagent grade water and 58% in groundwaters. EPA Method 1615 is being used by a number of national and international labs. This paper and the accompanying video will provide training oppo

Quality in the molecular microbiology laboratory.

PubMed

Wallace, Paul S; MacKay, William G

2013-01-01

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

Increasing the technical level of mining haul trucks

NASA Astrophysics Data System (ADS)

Voronov, Yuri; Voronov, Artyom; Grishin, Sergey; Bujankin, Alexey

2017-11-01

Theoretical and methodological fundamentals of mining haul trucks optimal design are articulated. Methods based on the systems approach to integrated assessment of truck technical level and methods for optimization of truck parameters depending on performance standards are provided. The results of using these methods are given. The developed method allows not only assessing the truck technical levels but also choosing the most promising models and providing quantitative evaluations of the decisions to be made at the design stage. These areas are closely connected with the problem of improvement in the industrial output quality, which, being a part of the widely spread in Western world "total quality control" ideology, is one of the major issues for the Russian economy.

Assessment of the Reporting Quality of Placebo-controlled Randomized Trials on the Treatment of Type 2 Diabetes With Traditional Chinese Medicine in Mainland China: A PRISMA-Compliant Systematic Review.

PubMed

Zhao, Xiyan; Zhen, Zhong; Guo, Jing; Zhao, Tianyu; Ye, Ru; Guo, Yu; Chen, Hongdong; Lian, Fengmei; Tong, Xiaolin

2016-01-01

Placebo-controlled randomized trials are often used to evaluate the absolute effect of new treatments and are considered gold standard for clinical trials. No studies, however, have yet been conducted evaluating the reporting quality of placebo-controlled randomized trials. The current study aims to assess the reporting quality of placebo-controlled randomized trials on treatment of diabetes with Traditional Chinese Medicine (TCM) in Mainland China and to provide recommendations for improvements.China National Knowledge Infrastructure database, Wanfang database, China Biology Medicine database, and VIP database were searched for placebo-controlled randomized trials on treatment of diabetes with TCM. Review, animal experiment, and randomized controlled trials without placebo control were excluded. According to Consolidated Standards of Reporting Trials (CONSORT) 2010 checklists items, each item was given a yes or no depending on whether it was reported or not.A total of 68 articles were included. The reporting percentage in each article ranged from 24.3% to 73%, and 30.9% articles reported more than 50% of the items. Seven of the 37 items were reported more than 90% of the items, whereas 7 items were not mentioned at all. The average reporting for "title and abstract," "introduction," "methods," "results," "discussion," and "other information" was 43.4%, 78.7%, 40.1%, 49.9%, 71.1%, and 17.2%, respectively. The percentage of each section had increased after 2010. In addition, the reporting of multiple study centers, funding, placebo species, informed consent forms, and ethical approvals were 14.7%, 50%, 36.85%, 33.8%, and 4.4%, respectively.Although a scoring system was created according to the CONSORT 2010 checklist, it was not designed as an assessment tool. According to CONSORT 2010, the reporting quality of placebo-controlled randomized trials on the treatment of diabetes with TCM improved after 2010. Future improvements, however, are still needed, particularly in methods sections.

Quality management in in vivo proton MRS.

PubMed

Pedrosa de Barros, Nuno; Slotboom, Johannes

2017-07-15

The quality of MR-Spectroscopy data can easily be affected in in vivo applications. Several factors may produce signal artefacts, and often these are not easily detected, not even by experienced spectroscopists. Reliable and reproducible in vivo MRS-data requires the definition of quality requirements and goals, implementation of measures to guarantee quality standards, regular control of data quality, and a continuous search for quality improvement. The first part of this review includes a general introduction to different aspects of quality management in MRS. It is followed by the description of a series of tests and phantoms that can be used to assure the quality of the MR system. In the third part, several methods and strategies used for quality control of the spectroscopy data are presented. This review concludes with a reference to a few interesting techniques and aspects that may help to further improve the quality of in vivo MR-spectra. Copyright © 2017 Elsevier Inc. All rights reserved.

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

Chen, L; Shen, C; Wang, J

Purpose: To reduce cone beam CT (CBCT) imaging dose, we previously proposed a progressive dose control (PDC) scheme to employ temporal correlation between CBCT images at different fractions for image quality enhancement. A temporal non-local means (TNLM) method was developed to enhance quality of a new low-dose CBCT using existing high-quality CBCT. To enhance a voxel value, the TNLM method searches for similar voxels in a window. Due to patient deformation among the two CBCTs, a large searching window was required, reducing image quality and computational efficiency. This abstract proposes a deformation-assisted TNLM (DA-TNLM) method to solve this problem. Methods:more » For a low-dose CBCT to be enhanced using a high-quality CBCT, we first performed deformable image registration between the low-dose CBCT and the high-quality CBCT to approximately establish voxel correspondence between the two. A searching window for a voxel was then set based on the deformation vector field. Specifically, the search window for each voxel was shifted by the deformation vector. A TNLM step was then applied using only voxels within this determined window to correct image intensity at the low-dose CBCT. Results: We have tested the proposed scheme on simulated CIRS phantom data and real patient data. The CITS phantom was scanned on Varian onboard imaging CBCT system with coach shifting and dose reducing for each time. The real patient data was acquired in four fractions with dose reduced from standard CBCT dose to 12.5% of standard dose. It was found that the DA-TNLM method can reduce total dose by over 75% on average in the first four fractions. Conclusion: We have developed a PDC scheme which can enhance the quality of image scanned at low dose using a DA-TNLM method. Tests in phantom and patient studies demonstrated promising results.« less

Methods for reducing biases and errors in regional photochemical model outputs for use in emission reduction and exposure assessments

EPA Science Inventory

In the United States, regional-scale photochemical models are being used to design emission control strategies needed to meet the relevant National Ambient Air Quality Standards (NAAQS) within the framework of the attainment demonstration process. Previous studies have shown that...

Modified ecometric technique (four-quadrant sequential streak) to evaluate Campylobacter enrichment broth proficiency in suppressing background microflora

USDA-ARS?s Scientific Manuscript database

Ecometric technique is a semi-quantitative scoring method used for quality control of culture media in microbiological laboratories. The technique involves inoculation with defined populations of specific culture onto solid media via a standardized chronological streaking technique, leading to ever-...

Problem-Solving Therapy for Depression in Adults: A Systematic Review

ERIC Educational Resources Information Center

Gellis, Zvi D.; Kenaley, Bonnie

2008-01-01

Objectives: This article presents a systematic review of the evidence on problem-solving therapy (PST) for depressive disorders in noninstitutionalized adults. Method: Intervention studies using randomized controlled designs are included and methodological quality is assessed using a standard set of criteria from the Cochrane Collaborative Review…

Bibliographic Control of Large Quantities of Research Material.

ERIC Educational Resources Information Center

Evans, Martha M.

1983-01-01

Guidelines for individual researcher describe bibliographic methods for achieving high standards of quality while maintaining maximum efficiency in each step of all necessary procedures involved in the construction of a bibliography ranging from several hundred to several thousand items. Ways to minimize waste motion and duplication of effort are…

[HPLC fingerprint chromatogram of Polygonum multiflorum from Guizhou].

PubMed

Li, Yan; Wang, Hui-Juan; Lin, Bing; Zhao, Zhi; Zhou, Ying

2012-12-01

To establish the fingerprint of Polygonum multiflorum from Guizhou and provide a standard for its quality control. HPLC analysis was performed on Agillent ZABAX-C18 (4.6 mm x 250 mm, 5 microm), gradient eluted composed of acetonitrile-0.4% water solution of phosphoric acid. Column temperature was set at 25 degrees C and the flow rate was 1 mL/min. The detection wavelength was 280 nm and the analysis time was 60 min. 9 common peaks were identified. The RSD of the relative retention time and the relative peak area were less than 3% in analyzing its precision, stability and repeatability of the common peaks, and the similarity of the 16 batches of sample was more than 0.9. The method is simple and reliable, and it can provide a standard and guidance for quality control of Polygonum multiflorum.

Setting up the criteria and credit-awarding scheme for building interior material selection to achieve better indoor air quality.

PubMed

Niu, J L; Burnett, J

2001-06-01

Methods, standards, and regulations that are aimed to reduce indoor air pollution from building materials are critically reviewed. These are classified as content control and emission control. Methods and standards can be found in both of these two classes. In the regulation domain, only content control is enforced in some countries and some regions, and asbestos is the only building material that is banned for building use. The controlled pollutants include heavy metals, radon, formaldehyde, and volatile organic compounds (VOCs). Emission rate control based upon environment chamber testing is very much in the nature of voluntary product labeling and ranking, and this mainly targets formaldehyde and VOC emissions. It is suggested that radon emission from building materials should be subject to similar emission rate control. A comprehensive set criteria and credit-awarding scheme that encourages the use of low-emission building material is synthesized, and how this scheme can be practiced in building design is proposed and discussed.

Deliberate Practice Enhances Quality of Laparoscopic Surgical Performance in a Randomized Controlled Trial: from Arrested Development to Expert Performance

PubMed Central

Hashimoto, Daniel A.; Sirimanna, Pramudith; Gomez, Ernest D.; Beyer-Berjot, Laura; Ericsson, K. Anders; Williams, Noel N.; Darzi, Ara; Aggarwal, Rajesh

2014-01-01

Background This study investigated whether deliberate practice leads to an increase in surgical quality in virtual reality (VR) laparoscopic cholecystectomies (LC). Previous research has suggested that sustained DP is effective in surgical training. Methods Fourteen residents were randomized into deliberate practice (n=7) or control training (n=7). Both groups performed 10 sessions of two VR LCs. Each session, the DP group was assigned 30 minutes of DP activities in between LCs while the control group viewed educational videos or read journal articles. Performance was assessed on speed and dexterity; quality was rated with global (GRS) and procedure-specific (PSRS) rating scales. All participants then performed five porcine LCs. Results Both groups improved over 20 VR LCs in time, dexterity, and global rating scales (all p<0.05). After 20 LCs, there were no differences in speed or dexterity between groups. The DP group achieved higher quality of VR surgical performance than control for GRS (26 vs. 20, p=0.001) and PSRS (18 vs. 15, p=0.001). For VR cases, DP subjects plateaued at GRS=25 after 10 cases and control group at GRS=20 after five cases. At completion of VR training, 100% of the DP group reached target quality of performance (GRS≥21) compared to 30% in the control group. There were no significant differences for improvements in time or dexterity over five porcine LCs. Conclusion This study suggests that DP leads to higher quality performance in VR LC than standard training alone. Standard training may leave individuals in a state of “arrested development” compared to DP. PMID:25539697

Journal of Air Transportation, Volume 12, No. 1

NASA Technical Reports Server (NTRS)

Bowers, Brent D. (Editor); Kabashkin, Igor (Editor)

2007-01-01

Topics discussed include: a) Data Mining Methods Applied to Flight Operations Quality Assurance Data: A Comparison to Standard Statistical Methods; b) Financial Comparisons across Different Business Models in the Canadian Airline Industry; c) Carving a Niche for the "No-Frills" Carrier, Air Arabia, in Oil-Rich Skies; d) Situational Leadership in Air Traffic Control; and e) The Very Light Jet Arrives: Stakeholders and Their Perceptions.

[Identification of impurity peaks in the HPLC chromatogram by LC-MS and two-dimensional chromatographic correlation spectroscopy].

PubMed

Chen, Zhen-Zhen; Zhang, Dou-Sheng; Wang, Nan; Feng, Fang; Hu, Chang-Qin

2012-04-01

A novel qualitative analytical method by using two-dimensional chromatographic correlation spectroscopy techniques for recognizing impurity peaks of HPLC methods of quality control and LC-MS chromatographic system was established. The structures of major degradation products of ceftizoxime and cefdinir were identified by LC-MS and MassWorks application; the standard chromatographic and spectral data of the degradation impurities were obtained by high-performance liquid chromatography with diode array detection. The impurity peaks of two-dimensional chromatography were matched by comparison of spectra and calculating correlation coefficients. Peaks in chromatography can be identified accurately and rapidly in different chromatographic systems such as column and mobile phase changed. The method provides a new way and thought to identify the peaks in quality control of impurities without reference impurity substances.

Quality control in urinalysis.

PubMed

Takubo, T; Tatsumi, N

1999-01-01

Quality control (QC) has been introduced in laboratories, and QC surveys in urinalysis have been performed by College of American Pathologist, by Japanese Association of Medical Technologists, by Osaka Medical Association and by manufacturers. QC survey in urinalysis for synthetic urine by the reagent strip and instrument made in same manufacturer, and by an automated urine cell analyser provided satisfactory results among laboratories. QC survey in urinalysis for synthetic urine by the reagent strips and instruments made by various manufacturers indicated differences in the determination values among manufacturers, and between manual and automated methods because the reagent strips and instruments have different characteristics, respectively. QC photo survey in urinalysis on the microscopic photos of urine sediment constituents indicated differences in the identification of cells among laboratories. From the results, it is necessary to standardize a reagent strip method, manual and automated methods, and synthetic urine.

Softcopy quality ruler method: implementation and validation

NASA Astrophysics Data System (ADS)

Jin, Elaine W.; Keelan, Brian W.; Chen, Junqing; Phillips, Jonathan B.; Chen, Ying

2009-01-01

A softcopy quality ruler method was implemented for the International Imaging Industry Association (I3A) Camera Phone Image Quality (CPIQ) Initiative. This work extends ISO 20462 Part 3 by virtue of creating reference digital images of known subjective image quality, complimenting the hardcopy Standard Reference Stimuli (SRS). The softcopy ruler method was developed using images from a Canon EOS 1Ds Mark II D-SLR digital still camera (DSC) and a Kodak P880 point-and-shoot DSC. Images were viewed on an Apple 30in Cinema Display at a viewing distance of 34 inches. Ruler images were made for 16 scenes. Thirty ruler images were generated for each scene, representing ISO 20462 Standard Quality Scale (SQS) values of approximately 2 to 31 at an increment of one just noticeable difference (JND) by adjusting the system modulation transfer function (MTF). A Matlab GUI was developed to display the ruler and test images side-by-side with a user-adjustable ruler level controlled by a slider. A validation study was performed at Kodak, Vista Point Technology, and Aptina Imaging in which all three companies set up a similar viewing lab to run the softcopy ruler method. The results show that the three sets of data are in reasonable agreement with each other, with the differences within the range expected from observer variability. Compared to previous implementations of the quality ruler, the slider-based user interface allows approximately 2x faster assessments with 21.6% better precision.

Quality assurance: Importance of systems and standard operating procedures

PubMed Central

Manghani, Kishu

2011-01-01

It is mandatory for sponsors of clinical trials and contract research organizations alike to establish, manage and monitor their quality control and quality assurance systems and their integral standard operating procedures and other quality documents to provide high-quality products and services to fully satisfy customer needs and expectations. Quality control and quality assurance systems together constitute the key quality systems. Quality control and quality assurance are parts of quality management. Quality control is focused on fulfilling quality requirements, whereas quality assurance is focused on providing confidence that quality requirements are fulfilled. The quality systems must be commensurate with the Company business objectives and business model. Top management commitment and its active involvement are critical in order to ensure at all times the adequacy, suitability, effectiveness and efficiency of the quality systems. Effective and efficient quality systems can promote timely registration of drugs by eliminating waste and the need for rework with overall financial and social benefits to the Company. PMID:21584180

Quality assurance: Importance of systems and standard operating procedures.

PubMed

Manghani, Kishu

2011-01-01

It is mandatory for sponsors of clinical trials and contract research organizations alike to establish, manage and monitor their quality control and quality assurance systems and their integral standard operating procedures and other quality documents to provide high-quality products and services to fully satisfy customer needs and expectations. Quality control and quality assurance systems together constitute the key quality systems. Quality control and quality assurance are parts of quality management. Quality control is focused on fulfilling quality requirements, whereas quality assurance is focused on providing confidence that quality requirements are fulfilled. The quality systems must be commensurate with the Company business objectives and business model. Top management commitment and its active involvement are critical in order to ensure at all times the adequacy, suitability, effectiveness and efficiency of the quality systems. Effective and efficient quality systems can promote timely registration of drugs by eliminating waste and the need for rework with overall financial and social benefits to the Company.

Chemistry and quality of Hibiscus (Hibiscus sabdariffa) for developing the natural-product industry in Senegal.

PubMed

Juliani, H R; Welch, C R; Wu, Q; Diouf, B; Malainy, D; Simon, J E

2009-03-01

The objectives of this study were to assess and improve the quality of the hibiscus calyces from Senegal over 2 production seasons (2004 to 2005), to develop and adapt new procedures for the determination of hibiscus anthocyanins and analysis of the 2 major ones, delphinidin-3-sambubioside and cyanidin-3-sambubioside. The foreign matter, total ashes, and acid insoluble ashes showed that the calyces harvested in 2005 were produced following hygienic practices, while the color assessment of the calyces and analysis of hibiscus active principles also showed higher amounts of anthocyanins in 2005. A protocol to measure anthocyanins by pH-differential UV-Vis spectrophotometry was adapted to measure the hibiscus anthocyanins from a water extract. The spectrophotometric method for quantitation of total anthocyanins showed a close correlation (r(2)= 0.82) when compared with the HPLC method, suggesting the use of the colorimetric method in quality control programs as an affordable alternative method to assess anthocyanin content in hibiscus. New and raised standards for the cleanliness and active principle content in hibiscus are also proposed. This study demonstrated that the implementation of a quality control program and the application of agricultural good practices in the production and processing of hibiscus calyces can lead to higher quality natural plant products.

Lessons Learned on Quality (of) Standards

NASA Astrophysics Data System (ADS)

Gerlich, Rainer; Gerlich, Ralf

2011-08-01

Standards are used to describe and ensure the quality of products, services and processes throughout almost all branches of industry, including the field of software engineering. Contractors and suppliers are obligated by their customers and certification authorities to follow a certain set of standards during development. For example, a customer can easier actively participate in and control the contractor's process when enforcing a standard process..However, as with any requirement, a standard may also impede the contractor or supplier in assuring actual quality of the product in the sense of fitness for the purpose intended by the customer.This is the case when a standard defines specific quality assurance activities requiring a considerable amount of effort while other more efficient but equivalent or even superior approaches are blocked. Then improvement of the ratio between cost and quality exceeding miniscule advances is heavily impeded.While in some parts being too specific in defining the mechanisms of the enforced process, standards are sometimes too weak in defining the principles or goals on control of product quality.Therefore this paper addresses the following issues: (1) Which conclusions can be drawn on the quality and efficiency of a standard? (2) If and how is it possible to improve or evolve a standard? (3) How well does a standard guide a user towards high quality of the end product?One conclusion is that the analyzed standards do interfere with technological innovation, though the standards leave a lot of freedom for concretization and are understood as technology-independent.Another conclusion is that standards are not only a matter of quality but also a matter of competitiveness of the industry depending on resulting costs and time-to- market. When the costs induced by a standard are not adequate to the achievable quality, industry encounters a significant disadvantage.

Setting and Reviewing Standards to Control Ozone Pollution

EPA Pesticide Factsheets

Ozone standards are part of the National Ambient Air Quality Standards (NAAQS), which limit air pollution to protect health and the environment. Standards are periodically reviewed and updated, and air quality across the U.S. is measured against them.

Quality control of colonoscopy procedures: a prospective validated method for the evaluation of professional practices applicable to all endoscopic units.

PubMed

Coriat, R; Pommaret, E; Chryssostalis, A; Viennot, S; Gaudric, M; Brezault, C; Lamarque, D; Roche, H; Verdier, D; Parlier, D; Prat, F; Chaussade, S

2009-02-01

To produce valid information, an evaluation of professional practices has to assess the quality of all practices before, during and after the procedure under study. Several auditing techniques have been proposed for colonoscopy. The purpose of this work is to describe a straightforward original validated method for the prospective evaluation of professional practices in the field of colonoscopy applicable in all endoscopy units without increasing the staff work load. Pertinent quality-control criteria (14 items) were identified by the endoscopists at the Cochin Hospital and were compatible with: findings in the available literature; guidelines proposed by the Superior Health Authority; and application in any endoscopy unit. Prospective routine data were collected and the methodology validated by evaluating 50 colonoscopies every quarter for one year. The relevance of the criteria was assessed using data collected during four separate periods. The standard checklist was complete for 57% of the colonoscopy procedures. The colonoscopy procedure was appropriate according to national guidelines in 94% of cases. These observations were particularly noteworthy: the quality of the colonic preparation was insufficient for 9% of the procedures; complete colonoscopy was achieved for 93% of patients; and 0.38 adenomas and 0.045 carcinomas were identified per colonoscopy. This simple and reproducible method can be used for valid quality-control audits in all endoscopy units. In France, unit-wide application of this method enables endoscopists to validate 100 of the 250 points required for continuous medical training. This is a quality-control tool that can be applied annually, using a random month to evaluate any changes in routine practices.

18 CFR 12.40 - Quality control programs.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 18 Conservation of Power and Water Resources 1 2011-04-01 2011-04-01 false Quality control... PROJECT WORKS Other Responsibilities of Applicant or Licensee § 12.40 Quality control programs. (a... meeting any requirements or standards set by the Regional Engineer. If a quality control program is...

18 CFR 12.40 - Quality control programs.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Quality control... PROJECT WORKS Other Responsibilities of Applicant or Licensee § 12.40 Quality control programs. (a... meeting any requirements or standards set by the Regional Engineer. If a quality control program is...

7 CFR 930.44 - Quality control.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 8 2011-01-01 2011-01-01 false Quality control. 930.44 Section 930.44 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... Control § 930.44 Quality control. (a) Quality standards. The Board may establish, with the approval of the...

7 CFR 930.44 - Quality control.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 8 2010-01-01 2010-01-01 false Quality control. 930.44 Section 930.44 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... Control § 930.44 Quality control. (a) Quality standards. The Board may establish, with the approval of the...

7 CFR 930.44 - Quality control.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 8 2012-01-01 2012-01-01 false Quality control. 930.44 Section 930.44 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... Control § 930.44 Quality control. (a) Quality standards. The Board may establish, with the approval of the...

7 CFR 930.44 - Quality control.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 8 2013-01-01 2013-01-01 false Quality control. 930.44 Section 930.44 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (MARKETING AGREEMENTS... Control § 930.44 Quality control. (a) Quality standards. The Board may establish, with the approval of the...

Statistical tools for transgene copy number estimation based on real-time PCR.

PubMed

Yuan, Joshua S; Burris, Jason; Stewart, Nathan R; Mentewab, Ayalew; Stewart, C Neal

2007-11-01

As compared with traditional transgene copy number detection technologies such as Southern blot analysis, real-time PCR provides a fast, inexpensive and high-throughput alternative. However, the real-time PCR based transgene copy number estimation tends to be ambiguous and subjective stemming from the lack of proper statistical analysis and data quality control to render a reliable estimation of copy number with a prediction value. Despite the recent progresses in statistical analysis of real-time PCR, few publications have integrated these advancements in real-time PCR based transgene copy number determination. Three experimental designs and four data quality control integrated statistical models are presented. For the first method, external calibration curves are established for the transgene based on serially-diluted templates. The Ct number from a control transgenic event and putative transgenic event are compared to derive the transgene copy number or zygosity estimation. Simple linear regression and two group T-test procedures were combined to model the data from this design. For the second experimental design, standard curves were generated for both an internal reference gene and the transgene, and the copy number of transgene was compared with that of internal reference gene. Multiple regression models and ANOVA models can be employed to analyze the data and perform quality control for this approach. In the third experimental design, transgene copy number is compared with reference gene without a standard curve, but rather, is based directly on fluorescence data. Two different multiple regression models were proposed to analyze the data based on two different approaches of amplification efficiency integration. Our results highlight the importance of proper statistical treatment and quality control integration in real-time PCR-based transgene copy number determination. These statistical methods allow the real-time PCR-based transgene copy number estimation to be more reliable and precise with a proper statistical estimation. Proper confidence intervals are necessary for unambiguous prediction of trangene copy number. The four different statistical methods are compared for their advantages and disadvantages. Moreover, the statistical methods can also be applied for other real-time PCR-based quantification assays including transfection efficiency analysis and pathogen quantification.

Analysis of medical screening and surveillance in 21 Occupational Safety and Health Administration standards: support for a generic medical surveillance standard.

PubMed

Silverstein, M

1994-09-01

Twenty-one Occupational Safety and Health Act (OSHA) standards were identified which contain medical service provisions intended to help in the identification and control of harmful health effects of workplace exposures. The utility and effectiveness of these provisions have not previously been evaluated. All 21 standards were reviewed and assigned numerical scores for each of 24 potential medical program elements. Several of these elements were combined to calculate Quality Control, Screening Utility, and Surveillance Utility scores for each standard. Total scores varied greatly, suggesting a lack of consistency and uniformity which was even more obvious when the actual regulatory language was examined. The mean Quality score was only 26% of potential points. Seventeen of 21 standards received less than half the total possible Quality score. When arrayed on a two by two matrix only two standards scored above 50% for both Screening and Surveillance Utility. It was concluded that the medical service provisions in OSHA standards are lacking in consistency and coherence. Two major shortcomings are the lack of quality control elements and the absence of surveillance features which would permit medical program results to be utilized for prevention activities including the identification and control of workplace hazards. A generic occupational medical surveillance standard could address these current weaknesses. Elements of such a generic standard are proposed.

Likelihood of achieving air quality targets under model uncertainties.

PubMed

Digar, Antara; Cohan, Daniel S; Cox, Dennis D; Kim, Byeong-Uk; Boylan, James W

2011-01-01

Regulatory attainment demonstrations in the United States typically apply a bright-line test to predict whether a control strategy is sufficient to attain an air quality standard. Photochemical models are the best tools available to project future pollutant levels and are a critical part of regulatory attainment demonstrations. However, because photochemical models are uncertain and future meteorology is unknowable, future pollutant levels cannot be predicted perfectly and attainment cannot be guaranteed. This paper introduces a computationally efficient methodology for estimating the likelihood that an emission control strategy will achieve an air quality objective in light of uncertainties in photochemical model input parameters (e.g., uncertain emission and reaction rates, deposition velocities, and boundary conditions). The method incorporates Monte Carlo simulations of a reduced form model representing pollutant-precursor response under parametric uncertainty to probabilistically predict the improvement in air quality due to emission control. The method is applied to recent 8-h ozone attainment modeling for Atlanta, Georgia, to assess the likelihood that additional controls would achieve fixed (well-defined) or flexible (due to meteorological variability and uncertain emission trends) targets of air pollution reduction. The results show that in certain instances ranking of the predicted effectiveness of control strategies may differ between probabilistic and deterministic analyses.

42 CFR 493.1495 - Standard; Testing personnel responsibilities.

Code of Federal Regulations, 2010 CFR

2010-10-01

... samples are tested in the same manner as patient specimens; (3) Adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance... HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Personnel for Nonwaived...

Random Forest Application for NEXRAD Radar Data Quality Control

NASA Astrophysics Data System (ADS)

Keem, M.; Seo, B. C.; Krajewski, W. F.

2017-12-01

Identification and elimination of non-meteorological radar echoes (e.g., returns from ground, wind turbines, and biological targets) are the basic data quality control steps before radar data use in quantitative applications (e.g., precipitation estimation). Although WSR-88Ds' recent upgrade to dual-polarization has enhanced this quality control and echo classification, there are still challenges to detect some non-meteorological echoes that show precipitation-like characteristics (e.g., wind turbine or anomalous propagation clutter embedded in rain). With this in mind, a new quality control method using Random Forest is proposed in this study. This classification algorithm is known to produce reliable results with less uncertainty. The method introduces randomness into sampling and feature selections and integrates consequent multiple decision trees. The multidimensional structure of the trees can characterize the statistical interactions of involved multiple features in complex situations. The authors explore the performance of Random Forest method for NEXRAD radar data quality control. Training datasets are selected using several clear cases of precipitation and non-precipitation (but with some non-meteorological echoes). The model is structured using available candidate features (from the NEXRAD data) such as horizontal reflectivity, differential reflectivity, differential phase shift, copolar correlation coefficient, and their horizontal textures (e.g., local standard deviation). The influence of each feature on classification results are quantified by variable importance measures that are automatically estimated by the Random Forest algorithm. Therefore, the number and types of features in the final forest can be examined based on the classification accuracy. The authors demonstrate the capability of the proposed approach using several cases ranging from distinct to complex rain/no-rain events and compare the performance with the existing algorithms (e.g., MRMS). They also discuss operational feasibility based on the observed strength and weakness of the method.

Implementation of basic quality control tests for malaria medicines in Amazon Basin countries: results for the 2005–2010 period

PubMed Central

2012-01-01

Background Ensuring the quality of malaria medicines is crucial in working toward malaria control and eventual elimination. Unlike other validated tests that can assess all critical quality attributes, which is the standard for determining the quality of medicines, basic tests are significantly less expensive, faster, and require less skilled labour; yet, these tests provide reproducible data and information on several critical quality attributes, such as identity, purity, content, and disintegration. Visual and physical inspection also provides valuable information about the manufacturing and the labelling of medicines, and in many cases this inspection is sufficient to detect counterfeit medicines. The Promoting the Quality of Medicines (PQM) programme has provided technical assistance to Amazon Malaria Initiative (AMI) countries to implement the use of basic tests as a key screening mechanism to assess the quality of malaria medicines available to patients in decentralized regions. Methods Trained personnel from the National Malaria Control Programmes (NMCPs), often in collaboration with country’s Official Medicine Control Laboratory (OMCL), developed country- specific protocols that encompassed sampling methods, sample analysis, and data reporting. Sampling sites were selected based on malaria burden, accessibility, and geographical location. Convenience sampling was performed and countries were recommended to store the sampled medicines under conditions that did not compromise their quality. Basic analytical tests, such as disintegration and thin layer chromatography (TLC), were performed utilizing a portable mini-laboratory. Results Results were originally presented at regional meetings in a non-standardized format that lacked relevant medicines information. However, since 2008 information has been submitted utilizing a template specifically developed by PQM for that purpose. From 2005 to 2010, the quality of 1,663 malaria medicines from seven AMI countries was evaluated, mostly collected from the public sector, 1,445/1,663 (86.9%). Results indicate that 193/1,663 (11.6%) were found not to meet quality specifications. Most failures were reported during visual and physical inspection, 142/1663 (8.5%), and most of these were due to expired medicines, 118/142 (83.1%). Samples failing TLC accounted for 27/1,663 (1.6%) and those failing disintegration accounted for 24/1,663 (1.4%). Medicines quality failures decreased significantly during the last two years. Conclusions Basic tests revealed that the quality of medicines in the public sector improved over the years, since the implementation of this type of quality monitoring programme in 2005. However, the lack of consistent confirmatory tests in the quality control (QC) laboratory, utilizing methods that can also evaluate additional quality attributes, could still mask quality issues. In the future, AMI countries should improve coordination with their health authorities and their QC lab consistently, to provide a more complete picture of malaria medicines quality and support the implementation of corrective actions. Facilities in the private and informal sectors also should be included when these sectors constitute an important source of medicines used by malaria patients. PMID:22704680

The importance of quality control in validating concentrations of contaminants of emerging concern in source and treated drinking water samples.

PubMed

Batt, Angela L; Furlong, Edward T; Mash, Heath E; Glassmeyer, Susan T; Kolpin, Dana W

2017-02-01

A national-scale survey of 247 contaminants of emerging concern (CECs), including organic and inorganic chemical compounds, and microbial contaminants, was conducted in source and treated drinking water samples from 25 treatment plants across the United States. Multiple methods were used to determine these CECs, including six analytical methods to measure 174 pharmaceuticals, personal care products, and pesticides. A three-component quality assurance/quality control (QA/QC) program was designed for the subset of 174 CECs which allowed us to assess and compare performances of the methods used. The three components included: 1) a common field QA/QC protocol and sample design, 2) individual investigator-developed method-specific QA/QC protocols, and 3) a suite of 46 method comparison analytes that were determined in two or more analytical methods. Overall method performance for the 174 organic chemical CECs was assessed by comparing spiked recoveries in reagent, source, and treated water over a two-year period. In addition to the 247 CECs reported in the larger drinking water study, another 48 pharmaceutical compounds measured did not consistently meet predetermined quality standards. Methodologies that did not seem suitable for these analytes are overviewed. The need to exclude analytes based on method performance demonstrates the importance of additional QA/QC protocols. Published by Elsevier B.V.

[Work organisation improvement methods applied to activities of Blood Transfusion Establishments (BTE): Lean Manufacturing, VSM, 5S].

PubMed

Bertholey, F; Bourniquel, P; Rivery, E; Coudurier, N; Follea, G

2009-05-01

Continuous improvement of efficiency as well as new expectations from customers (quality and safety of blood products) and employees (working conditions) imply constant efforts in Blood Transfusion Establishments (BTE) to improve work organisations. The Lean method (from "Lean" meaning "thin") aims at identifying wastages in the process (overproduction, waiting, over-processing, inventory, transport, motion) and then reducing them in establishing a mapping of value chain (Value Stream Mapping). It consists in determining the added value of each step of the process from a customer perspective. Lean also consists in standardizing operations while implicating and responsabilizing all collaborators. The name 5S comes from the first letter of five operations of a Japanese management technique: to clear, rank, keep clean, standardize, make durable. The 5S method leads to develop the team working inducing an evolution of the way in the management is performed. The Lean VSM method has been applied to blood processing (component laboratory) in the Pays de la Loire BTE. The Lean 5S method has been applied to blood processing, quality control, purchasing, warehouse, human resources and quality assurance in the Rhône-Alpes BTE. The experience returns from both BTE shows that these methods allowed improving: (1) the processes and working conditions from a quality perspective, (2) the staff satisfaction, (3) the efficiency. These experiences, implemented in two BTE for different processes, confirm the applicability and usefulness of these methods to improve working organisations in BTE.

Automated standardization technique for an inductively-coupled plasma emission spectrometer

USGS Publications Warehouse

Garbarino, John R.; Taylor, Howard E.

1982-01-01

The manifold assembly subsystem described permits real-time computer-controlled standardization and quality control of a commercial inductively-coupled plasma atomic emission spectrometer. The manifold assembly consists of a branch-structured glass manifold, a series of microcomputer-controlled solenoid valves, and a reservoir for each standard. Automated standardization involves selective actuation of each solenoid valve that permits a specific mixed standard solution to be pumped to the nebulizer of the spectrometer. Quality control is based on the evaluation of results obtained for a mixed standard containing 17 analytes, that is measured periodically with unknown samples. An inaccurate standard evaluation triggers restandardization of the instrument according to a predetermined protocol. Interaction of the computer-controlled manifold assembly hardware with the spectrometer system is outlined. Evaluation of the automated standardization system with respect to reliability, simplicity, flexibility, and efficiency is compared to the manual procedure. ?? 1982.

Setting and Reviewing Standards to Control Lead (Pb) Pollution

EPA Pesticide Factsheets

Lead (Pb) standards are part of the National Ambient Air Quality Standards (NAAQS), which limit air pollution to protect health and the environment. Standards are periodically reviewed and updated, and air quality across the U.S. is measured against them.

Quality management standards for facility services in the Italian health care sector.

PubMed

Cesarotti, Vittorio; Di Silvio, Bruna

2006-01-01

Health care, one of the most dynamic sectors in Italy, is studied with a particular focus on outsourcing non-core activities such as facility management (FM) services. The project's goals are to define national standards to balance and control facility service evolution, and to drive FM services towards organisational excellence. The authors, in cooperation with a pool of facility service providers and hospitals managers, studied cleaning services--one of the most critical areas. This article describes the research steps and findings following definition and publication of the Italian standard and its application to an international benchmarking process. The method chosen for developing the Italian standard was to merge technical, strategic and organisational aspects with the goal of standardising the contracting system, giving service providers the chance to improve efficiency and quality, while helping healthcare organisations gain from a better, more reliable and less expensive service. The Italian standard not only improved services but also provided adequate control systems for outsourcing organisations. In this win-win context, it is hoped to continually drive FM services towards organisational excellence. This study is specific to the Italian national healthcare system. However, the strategic dynamics described are common to many other contexts. A systematic method for improving hospital FM services is presented. The authors believe that lessons learned from their Italian case study can be used to better understand and drive similar services in other countries or in other FM service outsourcing sectors.

Truth in Reporting: How Data Capture Methods Obfuscate Actual Surgical Site Infection Rates within a Health Care Network System.

PubMed

Bordeianou, Liliana; Cauley, Christy E; Antonelli, Donna; Bird, Sarah; Rattner, David; Hutter, Matthew; Mahmood, Sadiqa; Schnipper, Deborah; Rubin, Marc; Bleday, Ronald; Kenney, Pardon; Berger, David

2017-01-01

Two systems measure surgical site infection rates following colorectal surgeries: the American College of Surgeons National Surgical Quality Improvement Program and the Centers for Disease Control and Prevention National Healthcare Safety Network. The Centers for Medicare & Medicaid Services pay-for-performance initiatives use National Healthcare Safety Network data for hospital comparisons. This study aimed to compare database concordance. This is a multi-institution cohort study of systemwide Colorectal Surgery Collaborative. The National Surgical Quality Improvement Program requires rigorous, standardized data capture techniques; National Healthcare Safety Network allows 5 data capture techniques. Standardized surgical site infection rates were compared between databases. The Cohen κ-coefficient was calculated. This study was conducted at Boston-area hospitals. National Healthcare Safety Network or National Surgical Quality Improvement Program patients undergoing colorectal surgery were included. Standardized surgical site infection rates were the primary outcomes of interest. Thirty-day surgical site infection rates of 3547 (National Surgical Quality Improvement Program) vs 5179 (National Healthcare Safety Network) colorectal procedures (2012-2014). Discrepancies appeared: National Surgical Quality Improvement Program database of hospital 1 (N = 1480 patients) routinely found surgical site infection rates of approximately 10%, routinely deemed rate "exemplary" or "as expected" (100%). National Healthcare Safety Network data from the same hospital and time period (N = 1881) revealed a similar overall surgical site infection rate (10%), but standardized rates were deemed "worse than national average" 80% of the time. Overall, hospitals using less rigorous capture methods had improved surgical site infection rates for National Healthcare Safety Network compared with standardized National Surgical Quality Improvement Program reports. The correlation coefficient between standardized infection rates was 0.03 (p = 0.88). During 25 site-time period observations, National Surgical Quality Improvement Program and National Healthcare Safety Network data matched for 52% of observations (13/25). κ = 0.10 (95% CI, -0.1366 to 0.3402; p = 0.403), indicating poor agreement. This study investigated hospitals located in the Northeastern United States only. Variation in Centers for Medicare & Medicaid Services-mandated National Healthcare Safety Network infection surveillance methodology leads to unreliable results, which is apparent when these results are compared with standardized data. High-quality data would improve care quality and compare outcomes among institutions.

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

PubMed Central

Miller, Melissa B.; Hindler, Janet

2015-01-01

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

Ultra-performance liquid chromatography fingerprinting for quality control of Phragmitis rhizoma (Lugen) produced in Baiyangdian

PubMed Central

Li, Hong; Gao, Yu-Mei; Zhang, Jing; Wang, Lin; Wang, Xiao-Xin

2013-01-01

Objective: To establish an ultra-performance liquid chromatography (UPLC) fingerprinting method for quality control of Phragmitis rhizoma from Baiyangdian. Materials and Methods: Ultrasonic extraction with 70% methanol was performed on 10 samples of P. rhizoma collected from 10 different villages in Baiyangdian. The sample solutions were analyzed by Waters UPLC equipped with the ACQUITY UPLC BEH C18 column and photodiode array (PDA) detector, and gradient eluted with acetonitrile/water as the mobile phase. The flow rate was set to 0.1 mL/min; the column temperature was set to 25°C; and the detection wavelength was set to 285 nm. Results: The chromatograms of the 10 samples showed 27 common peaks, of which one was identified as the ferulic acid standard. The similarity indexes were all above 0.82. Hierarchical cluster analysis showed that the constituents and their quantities differed according to the diameter of the original plant, which is related to its age. Conclusion: The UPLC fingerprinting method had the advantages of being fast, accurate, and highly efficient; this indicated that it can be used for quality control of P. rhizoma produced in Baiyangdian. Also, the relation between the quality and diameter/age of the plant needs to be further investigated. PMID:24124278

A series of strategies for solving the shortage of reference standards for multi-components determination of traditional Chinese medicine, Mahoniae Caulis as a case.

PubMed

Wang, Wenguang; Ma, Xiaoli; Guo, Xiaoyu; Zhao, Mingbo; Tu, Pengfei; Jiang, Yong

2015-09-18

In order to solve the bottleneck of reference standards shortage for comprehensive quality control of traditional Chinese medicines (TCMs), a series of strategies, including one single reference standard to determine multi-compounds (SSDMC), quantitative analysis by standardized reference extract (QASRE), and quantitative nuclear magnetic resonance spectroscopy (qNMR) were proposed, and Mahoniae Caulis was selected as an example to develop and validate these methods for simultaneous determination of four alkaloids, columbamine, jatrorrhizine, palmatine, and berberine. Comprehensive comparisons among these methods and with the conventional external standard method (ESM) were carried out. The relative expanded uncertainty of measurement was firstly used to compare their credibility. The results showed that all these three new developed methods can accurately accomplish the quantification by using only one purified reference standard, but each of them has its own advantages and disadvantages as well as the specific application scope, which were also discussed in detail in this paper. Copyright © 2015 Elsevier B.V. All rights reserved.

qcML: An Exchange Format for Quality Control Metrics from Mass Spectrometry Experiments*

PubMed Central

Walzer, Mathias; Pernas, Lucia Espona; Nasso, Sara; Bittremieux, Wout; Nahnsen, Sven; Kelchtermans, Pieter; Pichler, Peter; van den Toorn, Henk W. P.; Staes, An; Vandenbussche, Jonathan; Mazanek, Michael; Taus, Thomas; Scheltema, Richard A.; Kelstrup, Christian D.; Gatto, Laurent; van Breukelen, Bas; Aiche, Stephan; Valkenborg, Dirk; Laukens, Kris; Lilley, Kathryn S.; Olsen, Jesper V.; Heck, Albert J. R.; Mechtler, Karl; Aebersold, Ruedi; Gevaert, Kris; Vizcaíno, Juan Antonio; Hermjakob, Henning; Kohlbacher, Oliver; Martens, Lennart

2014-01-01

Quality control is increasingly recognized as a crucial aspect of mass spectrometry based proteomics. Several recent papers discuss relevant parameters for quality control and present applications to extract these from the instrumental raw data. What has been missing, however, is a standard data exchange format for reporting these performance metrics. We therefore developed the qcML format, an XML-based standard that follows the design principles of the related mzML, mzIdentML, mzQuantML, and TraML standards from the HUPO-PSI (Proteomics Standards Initiative). In addition to the XML format, we also provide tools for the calculation of a wide range of quality metrics as well as a database format and interconversion tools, so that existing LIMS systems can easily add relational storage of the quality control data to their existing schema. We here describe the qcML specification, along with possible use cases and an illustrative example of the subsequent analysis possibilities. All information about qcML is available at http://code.google.com/p/qcml. PMID:24760958

qcML: an exchange format for quality control metrics from mass spectrometry experiments.

PubMed

Walzer, Mathias; Pernas, Lucia Espona; Nasso, Sara; Bittremieux, Wout; Nahnsen, Sven; Kelchtermans, Pieter; Pichler, Peter; van den Toorn, Henk W P; Staes, An; Vandenbussche, Jonathan; Mazanek, Michael; Taus, Thomas; Scheltema, Richard A; Kelstrup, Christian D; Gatto, Laurent; van Breukelen, Bas; Aiche, Stephan; Valkenborg, Dirk; Laukens, Kris; Lilley, Kathryn S; Olsen, Jesper V; Heck, Albert J R; Mechtler, Karl; Aebersold, Ruedi; Gevaert, Kris; Vizcaíno, Juan Antonio; Hermjakob, Henning; Kohlbacher, Oliver; Martens, Lennart

2014-08-01

Quality control is increasingly recognized as a crucial aspect of mass spectrometry based proteomics. Several recent papers discuss relevant parameters for quality control and present applications to extract these from the instrumental raw data. What has been missing, however, is a standard data exchange format for reporting these performance metrics. We therefore developed the qcML format, an XML-based standard that follows the design principles of the related mzML, mzIdentML, mzQuantML, and TraML standards from the HUPO-PSI (Proteomics Standards Initiative). In addition to the XML format, we also provide tools for the calculation of a wide range of quality metrics as well as a database format and interconversion tools, so that existing LIMS systems can easily add relational storage of the quality control data to their existing schema. We here describe the qcML specification, along with possible use cases and an illustrative example of the subsequent analysis possibilities. All information about qcML is available at http://code.google.com/p/qcml. © 2014 by The American Society for Biochemistry and Molecular Biology, Inc.

Are the defined substrate-based methods adequate to determine the microbiological quality of natural recreational waters?

PubMed

Valente, Marta Sofia; Pedro, Paulo; Alonso, M Carmen; Borrego, Juan J; Dionísio, Lídia

2010-03-01

Monitoring the microbiological quality of water used for recreational activities is very important to human public health. Although the sanitary quality of recreational marine waters could be evaluated by standard methods, they are time-consuming and need confirmation. For these reasons, faster and more sensitive methods, such as the defined substrate-based technology, have been developed. In the present work, we have compared the standard method of membrane filtration using Tergitol-TTC agar for total coliforms and Escherichia coli, and Slanetz and Bartley agar for enterococci, and the IDEXX defined substrate technology for these faecal pollution indicators to determine the microbiological quality of natural recreational waters. ISO 17994:2004 standard was used to compare these methods. The IDEXX for total coliforms and E. coli, Colilert, showed higher values than those obtained by the standard method. Enterolert test, for the enumeration of enterococci, showed lower values when compared with the standard method. It may be concluded that more studies to evaluate the precision and accuracy of the rapid tests are required in order to apply them for routine monitoring of marine and freshwater recreational bathing areas. The main advantages of these methods are that they are more specific, feasible and simpler than the standard methodology.

Metal-backed versus all-polyethylene tibial components in primary total knee arthroplasty

PubMed Central

2011-01-01

Background and purpose The choice of either all-polyethylene (AP) tibial components or metal-backed (MB) tibial components in total knee arthroplasty (TKA) remains controversial. We therefore performed a meta-analysis and systematic review of randomized controlled trials that have evaluated MB and AP tibial components in primary TKA. Methods The search strategy included a computerized literature search (Medline, EMBASE, Scopus, and the Cochrane Central Register of Controlled Trials) and a manual search of major orthopedic journals. A meta-analysis and systematic review of randomized or quasi-randomized trials that compared the performance of tibial components in primary TKA was performed using a fixed or random effects model. We assessed the methodological quality of studies using Detsky quality scale. Results 9 randomized controlled trials (RCTs) published between 2000 and 2009 met the inclusion quality standards for the systematic review. The mean standardized Detsky score was 14 (SD 3). We found that the frequency of radiolucent lines in the MB group was significantly higher than that in the AP group. There were no statistically significant differences between the MB and AP tibial components regarding component positioning, knee score, knee range of motion, quality of life, and postoperative complications. Interpretation Based on evidence obtained from this study, the AP tibial component was comparable with or better than the MB tibial component in TKA. However, high-quality RCTs are required to validate the results. PMID:21895503

40 CFR 131.35 - Colville Confederated Tribes Indian Reservation.

Code of Federal Regulations, 2011 CFR

2011-07-01

...-effective and reasonable best management practices for nonpoint source control. (iii) Where high quality... within areas designated as unique water quality management areas and waters otherwise of exceptional... PROGRAMS WATER QUALITY STANDARDS Federally Promulgated Water Quality Standards § 131.35 Colville...

US Fish and Wildlife Service biomonitoring operations manual, Appendices A--K

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

Gianotto, D.F.; Rope, R.C.; Mondecar, M.

1993-04-01

Volume 2 contains Appendices and Summary Sheets for the following areas: A-Legislative Background and Key to Relevant Legislation, B- Biomonitoring Operations Workbook, C-Air Monitoring, D-Introduction to the Flora and Fauna for Biomonitoring, E-Decontamination Guidance Reference Field Methods, F-Documentation Guidance, Sample Handling, and Quality Assurance/Quality Control Standard Operating Procedures, G-Field Instrument Measurements Reference Field Methods, H-Ground Water Sampling Reference Field Methods, I-Sediment Sampling Reference Field Methods, J-Soil Sampling Reference Field Methods, K-Surface Water Reference Field Methods. Appendix B explains how to set up strategy to enter information on the ``disk workbook``. Appendix B is enhanced by DE97006389, an on-line workbook formore » users to be able to make revisions to their own biomonitoring data.« less

HIV quality report cards: impact of case-mix adjustment and statistical methods.

PubMed

Ohl, Michael E; Richardson, Kelly K; Goto, Michihiko; Vaughan-Sarrazin, Mary; Schweizer, Marin L; Perencevich, Eli N

2014-10-15

There will be increasing pressure to publicly report and rank the performance of healthcare systems on human immunodeficiency virus (HIV) quality measures. To inform discussion of public reporting, we evaluated the influence of case-mix adjustment when ranking individual care systems on the viral control quality measure. We used data from the Veterans Health Administration (VHA) HIV Clinical Case Registry and administrative databases to estimate case-mix adjusted viral control for 91 local systems caring for 12 368 patients. We compared results using 2 adjustment methods, the observed-to-expected estimator and the risk-standardized ratio. Overall, 10 913 patients (88.2%) achieved viral control (viral load ≤400 copies/mL). Prior to case-mix adjustment, system-level viral control ranged from 51% to 100%. Seventeen (19%) systems were labeled as low outliers (performance significantly below the overall mean) and 11 (12%) as high outliers. Adjustment for case mix (patient demographics, comorbidity, CD4 nadir, time on therapy, and income from VHA administrative databases) reduced the number of low outliers by approximately one-third, but results differed by method. The adjustment model had moderate discrimination (c statistic = 0.66), suggesting potential for unadjusted risk when using administrative data to measure case mix. Case-mix adjustment affects rankings of care systems on the viral control quality measure. Given the sensitivity of rankings to selection of case-mix adjustment methods-and potential for unadjusted risk when using variables limited to current administrative databases-the HIV care community should explore optimal methods for case-mix adjustment before moving forward with public reporting. Published by Oxford University Press on behalf of the Infectious Diseases Society of America 2014. This work is written by (a) US Government employee(s) and is in the public domain in the US.

Formative evaluation of a patient-specific clinical knowledge summarization tool

PubMed Central

Del Fiol, Guilherme; Mostafa, Javed; Pu, Dongqiuye; Medlin, Richard; Slager, Stacey; Jonnalagadda, Siddhartha R.; Weir, Charlene R.

2015-01-01

Objective To iteratively design a prototype of a computerized clinical knowledge summarization (CKS) tool aimed at helping clinicians finding answers to their clinical questions; and to conduct a formative assessment of the usability, usefulness, efficiency, and impact of the CKS prototype on physicians’ perceived decision quality compared with standard search of UpToDate and PubMed. Materials and methods Mixed-methods observations of the interactions of 10 physicians with the CKS prototype vs. standard search in an effort to solve clinical problems posed as case vignettes. Results The CKS tool automatically summarizes patient-specific and actionable clinical recommendations from PubMed (high quality randomized controlled trials and systematic reviews) and UpToDate. Two thirds of the study participants completed 15 out of 17 usability tasks. The median time to task completion was less than 10 s for 12 of the 17 tasks. The difference in search time between the CKS and standard search was not significant (median = 4.9 vs. 4.5 min). Physician’s perceived decision quality was significantly higher with the CKS than with manual search (mean = 16.6 vs. 14.4; p = 0.036). Conclusions The CKS prototype was well-accepted by physicians both in terms of usability and usefulness. Physicians perceived better decision quality with the CKS prototype compared to standard search of PubMed and UpToDate within a similar search time. Due to the formative nature of this study and a small sample size, conclusions regarding efficiency and efficacy are exploratory. PMID:26612774

[Application progress on near infrared spectroscopy in quality control and process monitoring of traditional Chinese medicine].

PubMed

Li, Wenlong; Qu, Haibin

2017-01-25

The industry of traditional Chinese medicine (TCM) encounters problems like quality fluctuation of raw materials and unstandardized production process. Near infrared (NIR) spectroscopy technology is widely used in quality control of TCM because of its abundant information, fast and nondestructive characters. The main applications include quantitative analysis of Chinese medicinal materials, intermediates and Chinese patent medicines; the authenticity of TCM, species, origins and manufacturers; monitoring and control of the extraction, alcohol precipitation, column chromatography and blending process. This article reviews the progress on the application of NIR spectroscopy technology in TCM field. In view of the problems existing in the application, the article proposes that the standardization of NIR analysis method should be developed according to specific characteristics of TCM, which will promote the application of NIR technology in the TCM industry.

Eddy Current, Magnetic Particle and Hardness Testing, Aviation Quality Control (Advanced): 9227.04.

ERIC Educational Resources Information Center

Dade County Public Schools, Miami, FL.

This unit of instruction includes the principles of eddy current, magnetic particle and hardness testing; standards used for analyzing test results; techniques of operating equipment; interpretation of indications; advantages and limitations of these methods of testing; care and calibration of equipment; and safety and work precautions. Motion…

Ultrasonic Testing, Aviation Quality Control (Advanced): 9227.03.

ERIC Educational Resources Information Center

Dade County Public Schools, Miami, FL.

This unit of instruction covers the theory of ultrasonic sound, methods of applying soundwaves to test specimens and interpreting results, calibrating the ultrasonic equipment, and the use of standards. Study periods, group discussions, and extensive use of textbooks and training manuals are to be used. These are listed along with references and…

A four-quadrant sequential streak technique to evaluate Campylobacter selective broths for suppressing background flora in broiler carcass rinses

USDA-ARS?s Scientific Manuscript database

The ecometric technique is a semi-quantitative scoring method used in the quality control of culture media in microbiology laboratories. This technique involves inoculation with defined populations of a specific culture onto solid media via a standardized chronological streaking technique, leading ...

[Urinalysis in Italy in 2006].

PubMed

Gai, M; Lanfranco, G

2007-01-01

Urinalysis and proteinuria testing represent fundamental tests for the clinician, even though they too often lack standardization. Through the Italian Society of Nephrology Mailing List we sent a questionnaire to 282 centers, in order to assess the state of the art in Italy in the year 2006. 82% of the questionnaires were completed (nephrology laboratories: 64%, general laboratories: 36%). The questionnaire dealt with the main steps of preparation, analysis and report of urinalysis, and proteinuria / microalbuminuria measurement. 85% of the centers use first morning urine, and 7% second morning urine; only 57% of the centers supply with written instructions, 189 laboratories (82%) have only one bright field microscope, rate and time of centrifugation are very varied among centers, different units of measurement are used in reports. Few laboratories measure routinely the proteinuria / creatininuria ratio, there is no agreement on the urine sample type for microalbuminuria assay, total urinary proteins are measured through different methods. 92% of the centers is endowed with an internal quality control system, but only 47% participate in an external quality control program. These data confirm the lack of standardization for urine analysis methods and procedures.

Standards for the Analysis and Processing of Surface-Water Data and Information Using Electronic Methods

USGS Publications Warehouse

Sauer, Vernon B.

2002-01-01

Surface-water computation methods and procedures are described in this report to provide standards from which a completely automated electronic processing system can be developed. To the greatest extent possible, the traditional U. S. Geological Survey (USGS) methodology and standards for streamflow data collection and analysis have been incorporated into these standards. Although USGS methodology and standards are the basis for this report, the report is applicable to other organizations doing similar work. The proposed electronic processing system allows field measurement data, including data stored on automatic field recording devices and data recorded by the field hydrographer (a person who collects streamflow and other surface-water data) in electronic field notebooks, to be input easily and automatically. A user of the electronic processing system easily can monitor the incoming data and verify and edit the data, if necessary. Input of the computational procedures, rating curves, shift requirements, and other special methods are interactive processes between the user and the electronic processing system, with much of this processing being automatic. Special computation procedures are provided for complex stations such as velocity-index, slope, control structures, and unsteady-flow models, such as the Branch-Network Dynamic Flow Model (BRANCH). Navigation paths are designed to lead the user through the computational steps for each type of gaging station (stage-only, stagedischarge, velocity-index, slope, rate-of-change in stage, reservoir, tide, structure, and hydraulic model stations). The proposed electronic processing system emphasizes the use of interactive graphics to provide good visual tools for unit values editing, rating curve and shift analysis, hydrograph comparisons, data-estimation procedures, data review, and other needs. Documentation, review, finalization, and publication of records are provided for with the electronic processing system, as well as archiving, quality assurance, and quality control.

Exploiting Task Constraints for Self-Calibrated Brain-Machine Interface Control Using Error-Related Potentials

PubMed Central

Iturrate, Iñaki; Grizou, Jonathan; Omedes, Jason; Oudeyer, Pierre-Yves; Lopes, Manuel; Montesano, Luis

2015-01-01

This paper presents a new approach for self-calibration BCI for reaching tasks using error-related potentials. The proposed method exploits task constraints to simultaneously calibrate the decoder and control the device, by using a robust likelihood function and an ad-hoc planner to cope with the large uncertainty resulting from the unknown task and decoder. The method has been evaluated in closed-loop online experiments with 8 users using a previously proposed BCI protocol for reaching tasks over a grid. The results show that it is possible to have a usable BCI control from the beginning of the experiment without any prior calibration. Furthermore, comparisons with simulations and previous results obtained using standard calibration hint that both the quality of recorded signals and the performance of the system were comparable to those obtained with a standard calibration approach. PMID:26131890

Improvement in botanical standardization of commercial freeze-dried herbal extracts by using the combination of antioxidant capacity and constituent marker concentrations.

PubMed

Ninfali, Paolino; Gennari, Lorenzo; Biagiotti, Enrica; Cangi, Francesca; Mattoli, Luisa; Maidecchi, Anna

2009-01-01

Botanical extracts are standardized to > or = 1 marker compounds (MCs). This standardization provides a certain level of quality control, but not complete quality assurance. Thus, industries are looking for other satisfactory systems to improve standardization. This study focuses on the standardization of herbal medicines by combining 2 parameters: the concentration of the MC and antioxidant capacity. Antioxidant capacity was determined with the oxygen radical absorbance capacity (ORAC) method and the concentrations of the MCs, by high-performance liquid chromatography. Total phenols were also determined by the Folin-Ciocolteau method. The ORAC values, expressed as micromol Trolox equivalents/100 g (ORAC %), of 12 commercial herbal extracts were related to the ORAC values of the respective pure MCs at the concentrations at which the MCs occur in products (ORAC-MC %). The ORAC % values of 11 extracts were higher than those of the respective MCs and the ratios ORAC-MC %/ORAC % ranged from 0.007 to 0.7, whereas in the case of Olea europaea leaves, the same ratio was 1.36. The ORAC parameters and their ratios, as well as the linear relationship between ORAC-MC % and ORAC %, are described and discussed as tools for improving the standardization of herbal products and detecting modifications due to herb processing and storage.

Measuring the quality of infection control in Dutch nursing homes using a standardized method; the Infection prevention RIsk Scan (IRIS)

PubMed Central

2014-01-01

Background We developed a standardised method to assess the quality of infection control in Dutch Nursing Home (NH), based on a cross-sectional survey that visualises the results. The method was called the Infection control RIsk Infection Scan (IRIS). We tested the applicability of this new tool in a multicentre surveillance executed June and July 2012. Methods The IRIS includes two patient outcome-variables, i.e. the prevalence of healthcare associated infections (HAI) and rectal carriage of Extended-Spectrum Beta-Lactamase (ESBL) producing Enterobacteriaceae (ESBL-E); two patient-related risk factors, i.e. use of medical devices, and antimicrobial therapy; and three ward-related risk factors, i.e. environmental contamination, availability of local guidelines, and shortcomings in infection prevention preconditions. Results were categorised as low-, intermediate- and high risk, presented in an easy-to-read graphic risk spider-plot. This plot was given as feedback to management and healthcare workers of the NH. Results Large differences were found among most the variables in the different NH. Common shortcomings were the availability of infection control guidelines and the level of environmental cleaning. Most striking differences were observed in the prevalence of ESBL carriage, ranged from zero to 20.6% (p < 0.001). Conclusions The IRIS provided a rapid and easy to understand assessment of the infection control situation of the participating NH. The results can be used to improve the quality of infection control based on the specific needs of a NH but needs further validation in future studies. Repeated measurement can determine the effectiveness of the interventions. This makes the IRIS a useful tool for quality systems. PMID:25243067

40 CFR 122.44 - Establishing limitations, standards, and other permit conditions (applicable to State NPDES...

Code of Federal Regulations, 2010 CFR

2010-07-01

... CWA; (6) Ensure consistency with the requirements of a Water Quality Management plan approved by EPA..., or controls a pollutant or practice not limited in the permit. (d) Water quality standards and State... quality standards established under section 303 of the CWA, including State narrative criteria for water...

Application of QC_DR software for acceptance testing and routine quality control of direct digital radiography systems: initial experiences using the Italian Association of Physicist in Medicine quality control protocol.

PubMed

Nitrosi, Andrea; Bertolini, Marco; Borasi, Giovanni; Botti, Andrea; Barani, Adriana; Rivetti, Stefano; Pierotti, Luisa

2009-12-01

Ideally, medical x-ray imaging systems should be designed to deliver maximum image quality at an acceptable radiation risk to the patient. Quality assurance procedures are employed to ensure that these standards are maintained. A quality control protocol for direct digital radiography (DDR) systems is described and discussed. Software to automatically process and analyze the required images was developed. In this paper, the initial results obtained on equipment of different DDR manufacturers were reported. The protocol was developed to highlight even small discrepancies in standard operating performance.

Method of fabricating optical waveguides by ion implantation doping

DOEpatents

Appleton, B.R.; Ashley, P.R.; Buchal, C.J.

1987-03-24

A method for fabricating high-quality optical waveguides in optical quality oxide crystals by ion implantation doping and controlled epitaxial recrystallization is provided. Masked LiNbO/sub 3/ crystals are implanted with high concentrations of Ti dopant at ion energies of about 360 keV while maintaining the crystal near liquid nitrogen temperature. Ion implantation doping produces an amorphous, Ti-rich nonequilibrium phase in the implanted region. Subsequent thermal annealing in a water-saturated oxygen atmosphere at up to 1000/degree/C produces solid-phase epitaxial regrowth onto the crystalline substrate. A high-quality crystalline layer results which incorporates the Ti into the crystal structure at much higher concentrations than is possible by standard diffusion techniques, and this implanted region has excellent optical waveguiding properties.

Natural Language Processing–Enabled and Conventional Data Capture Methods for Input to Electronic Health Records: A Comparative Usability Study

PubMed Central

Sheehan, Barbara; Stetson, Peter; Bhatt, Ashish R; Field, Adele I; Patel, Chirag; Maisel, James Mark

2016-01-01

Background The process of documentation in electronic health records (EHRs) is known to be time consuming, inefficient, and cumbersome. The use of dictation coupled with manual transcription has become an increasingly common practice. In recent years, natural language processing (NLP)–enabled data capture has become a viable alternative for data entry. It enables the clinician to maintain control of the process and potentially reduce the documentation burden. The question remains how this NLP-enabled workflow will impact EHR usability and whether it can meet the structured data and other EHR requirements while enhancing the user’s experience. Objective The objective of this study is evaluate the comparative effectiveness of an NLP-enabled data capture method using dictation and data extraction from transcribed documents (NLP Entry) in terms of documentation time, documentation quality, and usability versus standard EHR keyboard-and-mouse data entry. Methods This formative study investigated the results of using 4 combinations of NLP Entry and Standard Entry methods (“protocols”) of EHR data capture. We compared a novel dictation-based protocol using MediSapien NLP (NLP-NLP) for structured data capture against a standard structured data capture protocol (Standard-Standard) as well as 2 novel hybrid protocols (NLP-Standard and Standard-NLP). The 31 participants included neurologists, cardiologists, and nephrologists. Participants generated 4 consultation or admission notes using 4 documentation protocols. We recorded the time on task, documentation quality (using the Physician Documentation Quality Instrument, PDQI-9), and usability of the documentation processes. Results A total of 118 notes were documented across the 3 subject areas. The NLP-NLP protocol required a median of 5.2 minutes per cardiology note, 7.3 minutes per nephrology note, and 8.5 minutes per neurology note compared with 16.9, 20.7, and 21.2 minutes, respectively, using the Standard-Standard protocol and 13.8, 21.3, and 18.7 minutes using the Standard-NLP protocol (1 of 2 hybrid methods). Using 8 out of 9 characteristics measured by the PDQI-9 instrument, the NLP-NLP protocol received a median quality score sum of 24.5; the Standard-Standard protocol received a median sum of 29; and the Standard-NLP protocol received a median sum of 29.5. The mean total score of the usability measure was 36.7 when the participants used the NLP-NLP protocol compared with 30.3 when they used the Standard-Standard protocol. Conclusions In this study, the feasibility of an approach to EHR data capture involving the application of NLP to transcribed dictation was demonstrated. This novel dictation-based approach has the potential to reduce the time required for documentation and improve usability while maintaining documentation quality. Future research will evaluate the NLP-based EHR data capture approach in a clinical setting. It is reasonable to assert that EHRs will increasingly use NLP-enabled data entry tools such as MediSapien NLP because they hold promise for enhancing the documentation process and end-user experience. PMID:27793791

Quality control evaluation of Keshamasi, Keshanjana and Keshamasi eye ointment

PubMed Central

Dhiman, Kartar Singh; Shukla, Vinay J.; Bhalodia, Nayan R.; Sharma, Vinay R.

2014-01-01

Background: Keshanjana (collyrium) is a well known Ayurvedic preparation prepared out of Keshamasi (ash prepared by scalp hairs) mixed with Goghrita (cow's ghee). This medicine is indicated for the treatment of Shushkakshipaka (dry eye syndrome) in the classical literature of Ayurveda; hence, it was under taken for standardization and clinical evaluation in an extra-mural research project from Central Council for Research in Ayurvedic Sciences, Department of AYUSH, New Delhi. Aim: To develop standard quality parameters for the Keshamasi, Keshanjana and Keshamasi ointment. Materials and Methods: Scalp hairs of male and females collected from saloons were converted to classical Masi Kalpana and mixed with cow ghee and petrolatum in the ratio of 1:5 to prepare the Keshanjana and Keshamasi ointment respectively. Standard Operation Procedure (SOP) were adopted and recorded accordingly. The raw material, furnished products and plain Goghrita were subjected for quality control parameters i.e., physico-chemical evaluation, anti-microbial study, particle size analysis, heavy metal analysis through inductive couple plasma spectroscopy with high performance thin layer liquid chromatography fingerprints. Results: Rancidity was negative in all the samples, indicating that the physico-chemical parameters are in acceptable range. Lead and zinc were present in most of the samples; while all samples are were free from microbial contamination. Conclusion: As no standards are available to compare the results of the current study, the observations cannot be compared. Thus the profile generated in the current study can be considered as standard to refer in future studies. PMID:25364202

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

PubMed

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

2015-12-01

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

[Determination of heavy metals in four traditional Chinese medicines by ICP-MS].

PubMed

Wen, Hui-Min; Chen, Xiao-Hui; Dong, Ting-Xia; Zhan, Hua-Qiang; Bi, Kai-Shun

2006-08-01

To establish a ICP-MS method for the determination of heavy metals, including As, Hg, Pb, Cd, in four traditional Chinese medicines. The samples were digested by closed-versel microwave. The four heavy metals were directly analyzed by ICP-MS. Select internal standard element in for the method by which the analyse signal drife is corrected by the signal of another element (internal standard elements) added to both the standard solution and sample. For all of the analyzed heary methals, the correlative coefficient of the calibration curves was over 0.999 2. The recovery rates of the procedure were 97.5%-108.0%, and its RSD was lower than 11.6%. This method was convenient, quick-acquired, accurate and highly sensitive. The method can be used for the quality control of trace elements in traditional Chinese medicines and for the contents determination of traditional Chinese medicines from different habitats and species.

[Comparison between the LightCycler CMV Quant Kit (Roche Diagnostics) with a standardized in-house Taqman assay for cytomegalovirus blood viral load quantification].

PubMed

Alain, S; Lachaise, V; Hantz, S; Denis, F

2010-04-01

The broad use of cytomegalovirus (CMV) viral load quantification in blood to follow immunosuppressed patients need standardized assays. Choice of whole blood allows follow-up for several viruses and simplifies pretreatment and storage of samples. We therefore evaluated the LightCycler CMV Quant Kit (Roche Diagnostics) assay on whole blood after a manual extraction (High Pure viral nucleic acid kit, Roche Diagnostics), using as a reference an in-house Taqman assay (LC1UL83) which has been validated in various clinical situations. A panel obtained by serial dilutions of a virion stock in CMV whole blood, a commercial plasma quality control (VQC, Argène, France) crude or diluted in whole blood, infected cells extracts and 46 clinical samples from transplanted patients were tested simultaneously by both techniques. For plasma quality controls, both PCR assays are correlated VQC (R(2)=0.93). On whole blood or infected cells dilutions, correlation shows an overestimation by the LC1UL83 assay (mean 1.2 log copies/ml) over 3 log though R(2)=0.94. Results with CMV Quant Kit are closer to expected values. Results on clinical samples are close to quality controls with a lower variation of quantification (0.76 log copies/ml). CMV Quant Kit performs well when compared with a clinically validated PCR. Quality control results showed discrepancies between plasma and whole blood, demonstrating the need for whole blood standardized panels to compare the methods. This underlines the need to follow a patient with the same technique during his follow-up. Copyright 2009 Elsevier Masson SAS. All rights reserved.

Quality Control and Reproducibility in M-mode, Two-dimensional, and Speckle Tracking Echocardiography Acquisition and Analysis: The CARDIA Study, Year-25 Examination Experience

PubMed Central

Armstrong, Anderson C.; Ricketts, Erin P.; Cox, Christopher; Adler, Paul; Arynchyn, Alexander; Liu, Kiang; Stengel, Ellen; RDCS; Sidney, Stephen; Lewis, Cora E.; Schreiner, Pamela J.; Shikany, James M.; Keck, Kimberly; Merlo, Jamie; Gidding, Samuel S.; Lima, João A. C.

2014-01-01

Introduction Few large studies describe quality control procedures and reproducibility findings in cardiovascular ultra-sound, particularly in novel techniques such as Speckle Tracking (STE). We evaluate the echocardiography assessment performance in the CARDIA study Y25 examination (2010-2011) and report findings from a quality control and reproducibility program conducted to assess Field Center image acquisition and Reading Center (RC) accuracy. Methods The CARDIA Y25 examination had 3,475 echocardiograms performed in 4 US Field Centers and analyzed in a Reading Center, assessing standard echocardiography (LA dimension, aortic root, LV mass, LV end-diastolic volume [LVEDV], ejection fraction [LVEF]), and STE (2- and 4-chamber longitudinal, circumferential, and radial strains). Reproducibility was assessed using intra-class correlation coefficients (ICC), coefficients of variation (CV), and Bland-Altman plots. Results For standard echocardiography reproducibility, LV mass and LVEDV consistently had CV above 10% and aortic root below 6%. Intra-sonographer aortic root and LV mass had the most robust values of ICC in standard echocardiography. For STE, the number of properly tracking segments was above 80% in short-axis and 4-chamber and 58% in 2-chamber. Longitudinal strain parameters were the most robust and radial strain showed the highest variation. Comparing Field Centers with Echo RC STE readings, mean differences ranged from 0.4% to 4.1% and ICC from 0.37 to 0.66, with robust results for longitudinal strains. Conclusion Echocardiography image acquisition and reading processes in the CARDIA study were highly reproducible, including robust results for STE analysis. Consistent quality control may increase the reliability of echocardiography measurements in large cohort studies. PMID:25382818

New approaches for the standardization and validation of a real-time qPCR assay using TaqMan probes for quantification of yellow fever virus on clinical samples with high quality parameters

PubMed Central

Fernandes-Monteiro, Alice G; Trindade, Gisela F; Yamamura, Anna MY; Moreira, Otacilio C; de Paula, Vanessa S; Duarte, Ana Cláudia M; Britto, Constança; Lima, Sheila Maria B

2015-01-01

The development and production of viral vaccines, in general, involve several steps that need the monitoring of viral load throughout the entire process. Applying a 2-step quantitative reverse transcription real time PCR assay (RT-qPCR), viral load can be measured and monitored in a few hours. In this context, the development, standardization and validation of a RT-qPCR test to quickly and efficiently quantify yellow fever virus (YFV) in all stages of vaccine production are extremely important. To serve this purpose we used a plasmid construction containing the NS5 region from 17DD YFV to generate the standard curve and to evaluate parameters such as linearity, precision and specificity against other flavivirus. Furthermore, we defined the limits of detection as 25 copies/reaction, and quantification as 100 copies/reaction for the test. To ensure the quality of the method, reference controls were established in order to avoid false negative results. The qRT-PCR technique based on the use of TaqMan probes herein standardized proved to be effective for determining yellow fever viral load both in vivo and in vitro, thus becoming a very important tool to assure the quality control for vaccine production and evaluation of viremia after vaccination or YF disease. PMID:26011746

New approaches for the standardization and validation of a real-time qPCR assay using TaqMan probes for quantification of yellow fever virus on clinical samples with high quality parameters.

PubMed

Fernandes-Monteiro, Alice G; Trindade, Gisela F; Yamamura, Anna M Y; Moreira, Otacilio C; de Paula, Vanessa S; Duarte, Ana Cláudia M; Britto, Constança; Lima, Sheila Maria B

2015-01-01

The development and production of viral vaccines, in general, involve several steps that need the monitoring of viral load throughout the entire process. Applying a 2-step quantitative reverse transcription real time PCR assay (RT-qPCR), viral load can be measured and monitored in a few hours. In this context, the development, standardization and validation of a RT-qPCR test to quickly and efficiently quantify yellow fever virus (YFV) in all stages of vaccine production are extremely important. To serve this purpose we used a plasmid construction containing the NS5 region from 17DD YFV to generate the standard curve and to evaluate parameters such as linearity, precision and specificity against other flavivirus. Furthermore, we defined the limits of detection as 25 copies/reaction, and quantification as 100 copies/reaction for the test. To ensure the quality of the method, reference controls were established in order to avoid false negative results. The qRT-PCR technique based on the use of TaqMan probes herein standardized proved to be effective for determining yellow fever viral load both in vivo and in vitro, thus becoming a very important tool to assure the quality control for vaccine production and evaluation of viremia after vaccination or YF disease.

Closed-loop controller for chest compressions based on coronary perfusion pressure: a computer simulation study.

PubMed

Wang, Chunfei; Zhang, Guang; Wu, Taihu; Zhan, Ningbo; Wang, Yaling

2016-03-01

High-quality cardiopulmonary resuscitation contributes to cardiac arrest survival. The traditional chest compression (CC) standard, which neglects individual differences, uses unified standards for compression depth and compression rate in practice. In this study, an effective and personalized CC method for automatic mechanical compression devices is provided. We rebuild Charles F. Babbs' human circulation model with a coronary perfusion pressure (CPP) simulation module and propose a closed-loop controller based on a fuzzy control algorithm for CCs, which adjusts the CC depth according to the CPP. Compared with a traditional proportion-integration-differentiation (PID) controller, the performance of the fuzzy controller is evaluated in computer simulation studies. The simulation results demonstrate that the fuzzy closed-loop controller results in shorter regulation time, fewer oscillations and smaller overshoot than traditional PID controllers and outperforms the traditional PID controller for CPP regulation and maintenance.

Action for Environmental Quality. Standards and Enforcement for Air and Water Pollution Control.

ERIC Educational Resources Information Center

Environmental Protection Agency, Washington, DC.

The U.S. Environmental Protection Agency (EPA) is responsible for setting and enforcing environmental quality standards for the nation. With the Clean Air Act of 1970 (P.L. 91-604) and the Water Pollution Control Act of 1972 (P.L. 92-500), the first truly nationwide control programs were established. This booklet is designed to inform the public…

A novel method to produce armored double-stranded DNA by encapsulation of MS2 viral capsids.

PubMed

Zhang, Lei; Sun, Yu; Chang, Le; Jia, Tingting; Wang, Guojing; Zhang, Rui; Zhang, Kuo; Li, Jinming

2015-09-01

With the rapid development of molecular diagnostic techniques, there is a growing need for quality controls and standards with favorable properties to monitor the entire detection process. In this study, we describe a novel method to produce armored hepatitis B virus (HBV) and human papillomavirus (HPV) DNA for use in nucleic acid tests, which was confirmed to be stable, homogeneous, noninfectious, nuclease resistant, and safe for shipping. We demonstrated that MS2 bacteriophage could successfully package double-stranded DNA of 1.3-, 3-, 3.5-, and 6.5-kb length into viral capsids with high reassembly efficiency. This is the first application of RNA bacteriophage MS2 as a platform to encapsulate double-stranded DNA, forming virus-like particles (VLPs) which were indistinguishable from native MS2 capsids in size and morphology. Moreover, by analyzing the interaction mechanism of pac site and the MS2 coat protein (CP), we found that in addition to the recognized initiation signal TR-RNA, TR-DNA can also trigger spontaneous reassembly of CP dimers, providing a more convenient and feasible method of assembly. In conclusion, this straightforward and reliable manufacturing approach makes armored DNA an ideal control and standard for use in clinical laboratory tests and diagnostics, possessing prospects for broad application, especially providing a new platform for the production of quality controls for DNA viruses.

An HPLC/UV method for the determination of RGH-1756 in dog and rat plasma.

PubMed

Terjéki, E; Kapás, M

2001-03-01

RGH-1756 (1-(2-methoxy-phenyl)-4-(4-[4-(6-imidazo[2,1-b]-thiazolyl)-phenoxy]-butyl)-piperazine dimethansulphonate) is a novel atypical antipsychotic candidate of Gedeon Richter Ltd. A new HPLC method has been developed and validated for the quantitative determination of RGH-1756 in dog and rat plasma. The compound and the internal standard are extracted from the biological samples by a simple and fast liquid--liquid extraction method, using 1-chlorobutane. The recovery for RGH-1756 is about 90%. The extracts are analyzed by reversed phase HPLC (column: Supelcosil-LC-18-DB 250*4.6 mm, 5 microm, eluent:acetonitrile:methanol:0.2 molar ammonium-acetate 40:25:35, lambda=254 nm). The assay is specific for RGH-1756. The standard curves are linear in the range between 10 and 2000 ng ml(-1). The overall precision (expressed as CV%) and accuracy (expressed as bias%) of quality controls and calibration standards are within 15%. The validated lower limit of quantification is 10 ng/ml. No indications have been found for possible instabilities of RGH-1756 in plasma, in the extraction solvent, or after repeated thawing-freezing cycles. The method has been succesfully applied for the bioavailability studies of RGH-1756 in the two animal species. In these studies results of the inprocess method validation have shown the reliability of the method, too. CV% of quality controls in the rat study has been found between 7.4 and 10.0%, in the dog study between 4.1 and 12.5%. The bias has ranged from 0.4 to 3.8% and from -4.5 to 1.2% in the rat and dog study, respectively.

Standardization and quality control parameters for Muktā Bhasma (calcined pearl)

PubMed Central

Joshi, Namrata; Sharma, Khemchand; Peter, Hema; Dash, Manoj Kumar

2015-01-01

Background: Muktā Bhasma (MB) is a traditional Ayurvedic preparation for cough, breathlessness, and eye disorders and is a powerful cardiac tonic, mood elevator, and known to promote strength, intellect, and semen production. Objectives: The present research work was conducted to generate fingerprint for raw and processed MB for quality assessment and standardization using classical and other techniques. Setting and Design: Three samples of MB were prepared by purification (śodhana) of Muktā (pearl) followed by repeated calcinations (Māraṇa). Resultant product was subjected to organoleptic tests and Ayurvedic tests for quality control such as rekhāpūrṇatā, vāritaratva, and nirdhūmatva. Materials and Methods: For quality control, physicochemical parameters such as loss on drying, total ash value, acid insoluble ash, specific gravity, pH value, and other tests using techniques such as elemental analysis with energy dispersive X-ray analysis (EDAX), Structural study with powder X-ray diffraction, particle size with scanning electron microscopy (SEM) were carried out on raw Muktā, Śodhita Muktā, and triplicate batches of MB. Results: The study showed that the raw material Muktā was calcium carbonate in aragonite form, which on repeated calcinations was converted into a more stable calcite form. SEM studies revealed that in raw and purified materials the particles were found scattered and unevenly arranged in the range of 718.7–214.7 nm while in final product, uniformly arranged, stable, rod-shaped, and rounded particles with more agglomerates were observed in the range of 279.2–79.93 nm. EDAX analysis revealed calcium as a major ingredient in MB (average 46.32%) which increased gradually in the stages of processing (raw 34.11%, Śodhita 37.5%). Conclusion: Quality control parameters have been quantified for fingerprinting of MB prepared using a particular method. PMID:26600667

Implementation of a standardized out-of-hospital management method for Parkinson dysphagia.

PubMed

Wei, Hongying; Sun, Dongxiu; Liu, Meiping

2017-12-01

Our objective is to explore the effectiveness and feasibility of establishing a swallowing management clinic to implement out-of-hospital management for Parkinson disease (PD) patients with dysphagia. Two-hundred seventeen (217) voluntary PD patients with dysphagia in a PD outpatient clinic were divided into a control group with 100 people, and an experimental group with 117 people. The control group was given dysphagia rehabilitation guidance. The experimental group was presented with the standardized out-of-hospital management method as overall management and information and education materials. Rehabilitation efficiency and incidence rate of dysphagia, as well as relevant complications of both groups were compared after a 6-month intervention. Rehabilitation efficiency and the incidence rate of dysphagia including relevant complications of patients treated with the standardized out-of-hospital management were compared with those seen in the control group. The differences have distinct statistics meaning (p<0.01). Establishing a swallowing management protocol for outpatient setting can effectively help the recovery of the function of swallowing, reduce the incidence rate of dysphagia complications and improve the quality of life in patients with PD.

Quality Assurance Through Quality Improvement and Professional Development in the National Breast and Cervical Cancer Early Detection Program

PubMed Central

Siegl, Elvira J.; Miller, Jacqueline W.; Khan, Kris; Harris, Susan E.

2015-01-01

Quality assurance (QA) is the process of providing evidence that the outcome meets the established standards. Quality improvement (QI), by contrast, is the act of methodically developing ways to meet acceptable quality standards and evaluating current processes to improve overall performance. In the case of the National Breast and Cervical Cancer Early Detection Program (NBCCEDP), the desired outcome is the delivery of quality health care services to program clients. The NBCCEDP provides professional development to ensure that participating providers have current knowledge of evidence-based clinical standards regarding breast and cervical cancer screening and diagnosis and are monitoring women with abnormal screening results for timely follow-up. To assess the quality of clinical care provided to NBCCEDP clients, performance data are collected by NBCCEDP grantees and compared against predetermined Centers for Disease Control and Prevention (CDC) benchmarks known as Data Quality Indicator Guides. In this article, the authors describe 1) the development and use of indicators for QI in the NBCCEDP and 2) the professional development activities implemented to improve clinical outcomes. QA identifies problems, whereas QI systematically corrects them. The quality of service delivery and improved patient outcomes among NBCCEDP grantees has enhanced significantly because of continuous monitoring of performance and professional development. By using QA, NBCCEDP grantees can maximize the quality of patient screening, diagnostic services, and follow-up. Examples of grantee activities to maintain quality of care are also described in this report. PMID:25099901

MUSQA: a CS method to build a multi-standard quality management system

NASA Astrophysics Data System (ADS)

Cros, Elizabeth; Sneed, Isabelle

2002-07-01

CS Communication & Systèmes, through its long quality management experience, has been able to build and evolve its Quality Management System according to clients requirements, norms, standards and models (ISO, DO178, ECSS, CMM, ...), evolving norms (transition from ISO 9001:1994 to ISO 9001:2000) and the TQM approach, being currently deployed. The aim of this paper is to show how, from this enriching and instructive experience, CS has defined and formalised its method: MuSQA (Multi-Standard Quality Approach). This method allows to built a new Quality Management System or simplify and unify an existing one. MuSQA objective is to provide any organisation with an open Quality Management System, which is able to evolve easily and turns to be a useful instrument for everyone, operational as well as non-operational staff.

40 CFR 131.40 - Puerto Rico

Code of Federal Regulations, 2012 CFR

2012-07-01

... unrelated to water quality, preclude attainment of aquatic life protection uses; or (vi) Controls more... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS WATER QUALITY STANDARDS Federally Promulgated Water Quality Standards § 131.40 Puerto Rico (a) Use designations for marine waters...

40 CFR 131.40 - Puerto Rico

Code of Federal Regulations, 2013 CFR

2013-07-01

... unrelated to water quality, preclude attainment of aquatic life protection uses; or (vi) Controls more... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS WATER QUALITY STANDARDS Federally Promulgated Water Quality Standards § 131.40 Puerto Rico (a) Use designations for marine waters...

40 CFR 131.40 - Puerto Rico

Code of Federal Regulations, 2010 CFR

2010-07-01

... unrelated to water quality, preclude attainment of aquatic life protection uses; or (vi) Controls more... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS WATER QUALITY STANDARDS Federally Promulgated Water Quality Standards § 131.40 Puerto Rico (a) Use designations for marine waters...

40 CFR 131.40 - Puerto Rico

Code of Federal Regulations, 2014 CFR

2014-07-01

... unrelated to water quality, preclude attainment of aquatic life protection uses; or (vi) Controls more... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS WATER QUALITY STANDARDS Federally Promulgated Water Quality Standards § 131.40 Puerto Rico (a) Use designations for marine waters...

40 CFR 131.40 - Puerto Rico

Code of Federal Regulations, 2011 CFR

2011-07-01

... unrelated to water quality, preclude attainment of aquatic life protection uses; or (vi) Controls more... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS WATER QUALITY STANDARDS Federally Promulgated Water Quality Standards § 131.40 Puerto Rico (a) Use designations for marine waters...

Passive Sampling in Regulatory Chemical Monitoring of Nonpolar Organic Compounds in the Aquatic Environment.

PubMed

Booij, Kees; Robinson, Craig D; Burgess, Robert M; Mayer, Philipp; Roberts, Cindy A; Ahrens, Lutz; Allan, Ian J; Brant, Jan; Jones, Lisa; Kraus, Uta R; Larsen, Martin M; Lepom, Peter; Petersen, Jördis; Pröfrock, Daniel; Roose, Patrick; Schäfer, Sabine; Smedes, Foppe; Tixier, Céline; Vorkamp, Katrin; Whitehouse, Paul

2016-01-05

We reviewed compliance monitoring requirements in the European Union, the United States, and the Oslo-Paris Convention for the protection of the marine environment of the North-East Atlantic, and evaluated if these are met by passive sampling methods for nonpolar compounds. The strengths and shortcomings of passive sampling are assessed for water, sediments, and biota. Passive water sampling is a suitable technique for measuring concentrations of freely dissolved compounds. This method yields results that are incompatible with the EU's quality standard definition in terms of total concentrations in water, but this definition has little scientific basis. Insufficient quality control is a present weakness of passive sampling in water. Laboratory performance studies and the development of standardized methods are needed to improve data quality and to encourage the use of passive sampling by commercial laboratories and monitoring agencies. Successful prediction of bioaccumulation based on passive sampling is well documented for organisms at the lower trophic levels, but requires more research for higher levels. Despite the existence of several knowledge gaps, passive sampling presently is the best available technology for chemical monitoring of nonpolar organic compounds. Key issues to be addressed by scientists and environmental managers are outlined.

A randomized controlled trial examining Iyengar yoga for young adults with rheumatoid arthritis: a study protocol

PubMed Central

2011-01-01

Background Rheumatoid arthritis is a chronic, disabling disease that can compromise mobility, daily functioning, and health-related quality of life, especially in older adolescents and young adults. In this project, we will compare a standardized Iyengar yoga program for young people with rheumatoid arthritis to a standard care wait-list control condition. Methods/Design Seventy rheumatoid arthritis patients aged 16-35 years will be randomized into either the 6-week Iyengar yoga program (12 - 1.5 hour sessions twice weekly) or the 6-week wait-list control condition. A 20% attrition rate is anticipated. The wait-list group will receive the yoga program following completion of the first arm of the study. We will collect data quantitatively, using questionnaires and markers of disease activity, and qualitatively using semi-structured interviews. Assessments include standardized measures of general and arthritis-specific function, pain, mood, and health-related quality of life, as well as qualitative interviews, blood pressure/resting heart rate measurements, a medical exam and the assessment of pro-inflammatory cytokines. Data will be collected three times: before treatment, post-treatment, and two months following the treatment. Discussion Results from this study will provide critical data on non-pharmacologic methods for enhancing function in rheumatoid arthritis patients. In particular, results will shed light on the feasibility and potential efficacy of a novel intervention for rheumatoid arthritis symptoms, paving the way for a larger clinical trial. Trial Registration ClinicalTrials.gov NCT01096823 PMID:21255431

The use of autologous platelet-rich plasma in the orthopedic setting.

PubMed

Cohn, Claudia S; Lockhart, Evelyn; McCullough, J Jeffrey

2015-07-01

Autologous platelet-rich plasma (aPRP) is widely used with orthopedic patients to help treat injuries to tendons, cartilage, ligaments, and muscle. A comprehensive review of the literature was conducted to evaluate aPRP's efficacy and compare available methods. In addition, the production and administration of aPRP were explored. A literature search was performed. Randomized controlled clinical trials (RCTs) in orthopedic procedures on adult patients were included and assessed for methodologic quality. The main outcomes were pain relief, increase in function, structural integrity, and "healing" based on various validated scales. Twelve RCTs and one controlled cohort were included (four lateral epicondylitis, two chronic Achilles tendinopathy, two anterior cruciate ligament injury, and five rotator cuff injuries). Four trials reported some benefit from aPRP versus controls while eight trials found no benefit from aPRP applications versus control. One study had too many patients withdraw from the control arm for acceptable data interpretation. All protocols used a different aPRP formulation or method of delivery or application. Despite its popularity, there are no standardized criteria that define aPRP. Different techniques yield wide variability in terms of platelet count and concentration. These variations make it difficult to compare clinical trials that use aPRP or draw conclusions concerning its clinical efficacy in orthopedic procedures. Blood bankers have experience in the production of standardized blood components. This expertise may be used to develop and implement protocols for the production and administration of aPRP, as well as quality control measures. © 2015 AABB.

[Simultaneous quantitative analysis of five alkaloids in Sophora flavescens by multi-components assay by single marker].

PubMed

Chen, Jing; Wang, Shu-Mei; Meng, Jiang; Sun, Fei; Liang, Sheng-Wang

2013-05-01

To establish a new method for quality evaluation and validate its feasibilities by simultaneous quantitative assay of five alkaloids in Sophora flavescens. The new quality evaluation method, quantitative analysis of multi-components by single marker (QAMS), was established and validated with S. flavescens. Five main alkaloids, oxymatrine, sophocarpine, matrine, oxysophocarpine and sophoridine, were selected as analytes to evaluate the quality of rhizome of S. flavescens, and the relative correction factor has good repeatibility. Their contents in 21 batches of samples, collected from different areas, were determined by both external standard method and QAMS. The method was evaluated by comparison of the quantitative results between external standard method and QAMS. No significant differences were found in the quantitative results of five alkaloids in 21 batches of S. flavescens determined by external standard method and QAMS. It is feasible and suitable to evaluate the quality of rhizome of S. flavescens by QAMS.

Multifractal Properties of Process Control Variables

NASA Astrophysics Data System (ADS)

Domański, Paweł D.

2017-06-01

Control system is an inevitable element of any industrial installation. Its quality affects overall process performance significantly. The assessment, whether control system needs any improvement or not, requires relevant and constructive measures. There are various methods, like time domain based, Minimum Variance, Gaussian and non-Gaussian statistical factors, fractal and entropy indexes. Majority of approaches use time series of control variables. They are able to cover many phenomena. But process complexities and human interventions cause effects that are hardly visible for standard measures. It is shown that the signals originating from industrial installations have multifractal properties and such an analysis may extend standard approach to further observations. The work is based on industrial and simulation data. The analysis delivers additional insight into the properties of control system and the process. It helps to discover internal dependencies and human factors, which are hardly detectable.

Preparation of a Ytterbium-tagged Gunshot Residue Standard for Quality Control in the Forensic Analysis of GSR.

PubMed

Hearns, Nigel G R; Laflèche, Denis N; Sandercock, Mark L

2015-05-01

Preparation of a ytterbium-tagged gunshot residue (GSR) reference standard for scanning electron microscopy and energy dispersive X-ray spectroscopic (SEM-EDS) microanalysis is reported. Two different chemical markers, ytterbium and neodymium, were evaluated by spiking the primers of 38 Special ammunition cartridges (no propellant, no projectile) and discharging them onto 12.7 mm diameter aluminum SEM pin stubs. Following SEM-EDS microanalysis, the majority of tri-component particles containing lead, barium, and antimony (PbBaSb) were successfully tagged with the chemical marker. Results demonstrate a primer spiked with 0.75% weight percent of ytterbium nitrate affords PbBaSb particles characteristic of GSR with a ytterbium inclusion efficiency of between 77% and 100%. Reproducibility of the method was verified, and durability of the ytterbium-tagged tri-component particles under repeated SEM-EDS analysis was also tested. The ytterbium-tagged PbBaSb particles impart synthetic traceability to a GSR reference standard and are suitable for analysis alongside case work samples, as a positive control for quality assurance purposes. © 2015 American Academy of Forensic Sciences.

Development of Instrumental Techniques for Color Assessment of Camouflage Patterns

ERIC Educational Resources Information Center

Fang, Gang

2012-01-01

Camouflage fabrics are produced on a large scale for use in the US military and other applications. One of the highest volume camouflage fabrics is known as the Universal Camouflage Pattern (UCP) which is produced for the US Department of Defense. At present, no standard measurement-based color quality control method exists for camouflage…

DETERMINATION OF NATIONAL DIAGNOSTIC REFERENCE LEVELS IN COMPUTED TOMOGRAPHY EXAMINATIONS OF IRAN BY A NEW QUALITY CONTROL-BASED DOSE SURVEY METHOD.

PubMed

Sohrabi, Mehdi; Parsi, Masoumeh; Mianji, Fereidoun

2018-05-01

National diagnostic reference levels (NDRLs) of Iran were determined for the four most common CT examinations including head, sinus, chest and abdomen/pelvis. A new 'quality control (QC)-based dose survey method', as developed by us, was applied to 157 CT scanners in Iran (2014-15) with different slice classes, models and geographic spread across the country. The NDRLs for head, sinus, chest and abdomen/pelvis examinations are 58, 29, 12 and 14 mGy for CTDIVol and 750, 300, 300 and 650 mGy.cm for DLP, respectively. The 'QC-based dose survey method' was further proven that it is a simple, accurate and practical method for a time and cost-effective NDRLs determination. One effective approach for optimization of the CT examination protocols at the national level is the provision of an adequate standardized training of the radiologists, technicians and medical physicists on the patient radiation protection principles and implementation of the DRL concept in clinical practices.

Study on an Air Quality Evaluation Model for Beijing City Under Haze-Fog Pollution Based on New Ambient Air Quality Standards

PubMed Central

Li, Li; Liu, Dong-Jun

2014-01-01

Since 2012, China has been facing haze-fog weather conditions, and haze-fog pollution and PM2.5 have become hot topics. It is very necessary to evaluate and analyze the ecological status of the air environment of China, which is of great significance for environmental protection measures. In this study the current situation of haze-fog pollution in China was analyzed first, and the new Ambient Air Quality Standards were introduced. For the issue of air quality evaluation, a comprehensive evaluation model based on an entropy weighting method and nearest neighbor method was developed. The entropy weighting method was used to determine the weights of indicators, and the nearest neighbor method was utilized to evaluate the air quality levels. Then the comprehensive evaluation model was applied into the practical evaluation problems of air quality in Beijing to analyze the haze-fog pollution. Two simulation experiments were implemented in this study. One experiment included the indicator of PM2.5 and was carried out based on the new Ambient Air Quality Standards (GB 3095-2012); the other experiment excluded PM2.5 and was carried out based on the old Ambient Air Quality Standards (GB 3095-1996). Their results were compared, and the simulation results showed that PM2.5 was an important indicator for air quality and the evaluation results of the new Air Quality Standards were more scientific than the old ones. The haze-fog pollution situation in Beijing City was also analyzed based on these results, and the corresponding management measures were suggested. PMID:25170682

A Simple and Rapid UPLC-PDA Method for Quality Control of Nardostachys jatamansi.

PubMed

Zhang, Weize; Nan, Guo; Wu, Hong-Hua; Jiang, Miaomiao; Li, Tian-Xiang; Wang, Meng; Gao, Xiu-Mei; Zhu, Yan; Song, Yun Seon; Wang, Jiaming; Xu, Yan-Tong

2018-05-01

Nardostachys jatamansi is a well-documented herbal agent used to treat digestive and neuropsychiatric disorders in oriental medicinal systems. However, few simple, rapid, and comprehensive methods were reported for quality assessment and control of N. jatamansi . Herein, a UPLC with photodiode array detection method was developed for both fingerprint investigation of N. jatamansi and simultaneous quantitative analysis of the six serotonin transporter modulatory constituents in N. jatamansi . For chromatographic fingerprinting, 24 common peaks were selected as characteristic peaks to assess the consistency of N. jatamansi samples from different retail sources. Six of the common peaks (5, 7, 12: , and 16:  - 18: ) were identified as desoxo-narchinol A, buddleoside, isonardosinone, nardosinone, kanshone H, and (-)-aristolone, respectively, by phytochemical investigation. Five of the six compounds significantly either enhanced or inhibited serotonin transporter activity, while (-)-aristolone (18: ) didn't show any serotonin transporter activity. In quantitative analysis, the six compounds showed good linearity ( r  > 0.999) within test ranges. The precision, expressed as relative standard deviation, was in the range of 0.25 - 2.77%, and the recovery of the method was in the range of 92 - 105%. The UPLC-photodiode array detection-based fingerprint analysis and quantitative methods reported here could be used for routine quality control of N. jatamansi . Georg Thieme Verlag KG Stuttgart · New York.

Monitoring scale scores over time via quality control charts, model-based approaches, and time series techniques.

PubMed

Lee, Yi-Hsuan; von Davier, Alina A

2013-07-01

Maintaining a stable score scale over time is critical for all standardized educational assessments. Traditional quality control tools and approaches for assessing scale drift either require special equating designs, or may be too time-consuming to be considered on a regular basis with an operational test that has a short time window between an administration and its score reporting. Thus, the traditional methods are not sufficient to catch unusual testing outcomes in a timely manner. This paper presents a new approach for score monitoring and assessment of scale drift. It involves quality control charts, model-based approaches, and time series techniques to accommodate the following needs of monitoring scale scores: continuous monitoring, adjustment of customary variations, identification of abrupt shifts, and assessment of autocorrelation. Performance of the methodologies is evaluated using manipulated data based on real responses from 71 administrations of a large-scale high-stakes language assessment.

Effects of three highway-runoff detention methods on water quality of the surficial aquifer system in central Florida

USGS Publications Warehouse

Schiffer, D.M.

1989-01-01

Water quality of the surficial aquifer system in central Florida was evaluated at one exfiltration pipe, two ponds (detention and retention), and two swales in central Florida, representing three runoff-detention methods, to detect any effect from infiltrating highway runoff. Concentrations of major ions, metals, and nutrients in groundwater and bottom sediments were measured from 1984 through 1986. At each study area, constituent concentrations in groundwater near the structure were compared to concentrations in groundwater from an upgradient control site. Groundwater quality data were also pooled by detention method and statistically compared to detect any significant differences between methods. Significantly greater mean phosphorus concentrations in groundwater near the exfiltration pipe than those in the control well was the only evidence of increasing constituent concentrations in groundwater near structures. The quality of water was more variable, and had greater constituent concentrations in the unsaturated zone than in the saturated zone near the exfiltration pipe. Values of water quality variables measured in groundwater at all study areas generally were within State drinking water standards. The main exception was dissolved iron, which commonly exceeded 300 micrograms/L at one swale and the detention pond. Results of the study indicate that natural processes occurring in soils attenuate inorganic constituent concentrations prior to reaching the receiving groundwater. However, organic compounds detected in bottom sediments at the retention pond indicate a potential problem that may eventually affect the quality of the receiving groundwater. (USGS)

42 CFR 493.643 - Fee for determination of program compliance.

Code of Federal Regulations, 2010 CFR

2010-10-01

... laboratory's scope and volume of testing (excluding tests performed for quality control, quality assurance... procedure or examination for a single analyte. (Tests performed for quality control, quality assurance, and... HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS General Administration...

[Quality control of oral anticoagulant therapy in Primary Care in Madrid City, Spain: CHRONOS-TAO study].

PubMed

Alonso Roca, Rafael; Figueroa Guerrero, Carmen Arlene; Mainar de Paz, Victoria; Arribas García, M Paz; Sánchez Perruca, Luis; Rodríguez Barrientos, Ricardo; Casado López, Mariano; Pedraza Flechas, Ana M

2015-09-07

To determine quality control of patients with oral anticoagulant treatment recruited in Primary Care (PC) using the Rosendaal method to estimate time in therapeutic range (TTR) and comparing it with fraction of international normalized ratio (INR) in range and cross-sectional analysis (last INR registred). A retrospective observational study based on electronic medical record in routine clinical practice. PC centers (262) in Madrid. We included all patients with acenocumarol treatment, with an INR therapeutic range established between 2 and 3. We excluded patients with valvular pathology and disrupted clinical follow up in PC (<3 INR determinations in the studied period, a period of>90 days or ≥ 3 periods of>60 days between 2 determinations). The final population was 49,312 patients. The variables considered were all INR values and their respective dates. TTR was calculated by the 3 methods above mentioned. We considered "therapeutic range" INR between 2-3 and "adjusted range" INR between 1.8-3.2. Optimal control for each patient was considered TTR>60%. By using Rosendaal method, TTR was 66.8% (81.7% adjusted), with a percentage of total INR in range was 58.8% (66.5% adjusted), and, with the cross-sectional analysis, it was 70.5% (76.8% adjusted). Mean TTR was 65% (standard deviation 20.3), and the percentage of patients with TTR>60% was 63.3% (88.1% adjusted). The quality control of patients with oral anticoagulants in PC in Madrid is acceptable, similar or higher to other studies and pivotal trials of new anticoagulants. Compared to the Rosendaal method, total fraction of INR underestimates quality control, and cross-sectional analysis slightly overestimates it. Copyright © 2014 Elsevier España, S.L.U. All rights reserved.

A multi-factor designation method for mapping particulate-pollution control zones in China.

PubMed

Qin, Y; Xie, S D

2011-09-01

A multi-factor designation method for mapping particulate-pollution control zones was brought out through synthetically considering PM(10) pollution status, PM(10) anthropogenic emissions, fine particle pollution, long-range transport and economic situation. According to this method, China was divided into four different particulate-pollution control regions: PM Suspended Control Region, PM(10) Pollution Control Region, PM(2.5) Pollution Control Region and PM(10) and PM(2.5) Common Control Region, which accounted for 69.55%, 9.66%, 4.67% and 16.13% of China's territory, respectively. The PM(10) and PM(2.5) Common Control Region was mainly distributed in Bohai Region, Yangtze River Delta, Pearl River Delta, eastern of Sichuan province and Chongqing municipality, calling for immediate control of both PM(10) and PM(2.5). Cost-effective control effects can be achieved through concentrating efforts on PM(10) and PM(2.5) Common Control Region to address 60.32% of national PM(10) anthropogenic emissions. Air quality in districts belonging to PM(2.5) Pollution Control Region suggested that Chinese national ambient air quality standard for PM(10) was not strict enough. The result derived from application to China proved that this approach was feasible for mapping pollution control regions for a country with vast territory, complicated pollution characteristics and limited available monitoring data. Copyright © 2011 Elsevier B.V. All rights reserved.

Development of an environmental chamber for evaluating the performance of low-cost air quality sensors under controlled conditions

NASA Astrophysics Data System (ADS)

Papapostolou, Vasileios; Zhang, Hang; Feenstra, Brandon J.; Polidori, Andrea

2017-12-01

A state-of-the-art integrated chamber system has been developed for evaluating the performance of low-cost air quality sensors. The system contains two professional grade chamber enclosures. A 1.3 m3 stainless-steel outer chamber and a 0.11 m3 Teflon-coated stainless-steel inner chamber are used to create controlled aerosol and gaseous atmospheres, respectively. Both chambers are temperature and relative humidity controlled with capability to generate a wide range of environmental conditions. The system is equipped with an integrated zero-air system, an ozone and two aerosol generation systems, a dynamic dilution calibrator, certified gas cylinders, an array of Federal Reference Method (FRM), Federal Equivalent Method (FEM), and Best Available Technology (BAT) reference instruments and an automated control and sequencing software. Our experiments have demonstrated that the chamber system is capable of generating stable and reproducible aerosol and gas concentrations at low, medium, and high levels. This paper discusses the development of the chamber system along with the methods used to quantitatively evaluate sensor performance. Considering that a significant number of academic and research institutions, government agencies, public and private institutions, and individuals are becoming interested in developing and using low-cost air quality sensors, it is important to standardize the procedures used to evaluate their performance. The information discussed herein provides a roadmap for entities who are interested in characterizing air quality sensors in a rigorous, systematic and reproducible manner.

Effectiveness of external inspection of compliance with standards in improving healthcare organisation behaviour, healthcare professional behaviour or patient outcomes

PubMed Central

Flodgren, Gerd; Pomey, Marie-Pascale; Taber, Sarah A; Eccles, Martin P

2014-01-01

Background Inspection systems are used in health care to promote quality improvements, i.e. to achieve changes in organisational structures or processes, healthcare provider behaviour and patient outcomes. These systems are based on the assumption that externally promoted adherence to evidence-based standards (through inspection/assessment) will result in higher quality of health care. However, the benefits of external inspection in terms of organisational, provider and patient level outcomes are not clear. Objectives To evaluate the effectiveness of external inspection of compliance with standards in improving healthcare organisation behaviour, healthcare professional behaviour and patient outcomes. Search methods We searched the following electronic databases for studies: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effectiveness, Scopus, HMIC, Index to Theses and Intute from their inception dates up to May 2011. There was no language restriction and studies were included regardless of publication status. We searched the reference lists of included studies and contacted authors of relevant papers, accreditation bodies and the International Organization for Standardisation (ISO), regarding any further published or unpublished work. Selection criteria We included randomised controlled trials (RCTs), controlled clinical trials (CCTs), interrupted time-series (ITSs) and controlled before and after studies (CBAs) evaluating the effect of external inspection against external standards on healthcare organisation change, healthcare professional behaviour or patient outcomes in hospitals, primary healthcare organisations and other community-based healthcare organisations. Data collection and analysis Two review authors independently applied eligibility criteria, extracted data and assessed the risk of bias of each included study. Since meta-analysis was not possible, we produced a narrative results summary. Main results We identified one cluster-RCT involving 20 South African public hospitals (Salmon 2003) and one ITS involving all acute trusts in England (OPM 2009) for inclusion in this review. Salmon and colleagues (Salmon 2003) showed mixed effects of a hospital accreditation system on the compliance with COHSASA (the Council for Health Services Accreditation for South Africa) accreditation standards and eight indicators of hospital quality. Significantly improved total mean compliance score with COHSASA accreditation standards was found for 21/28 service elements: mean intervention effect (95% confidence interval (CI)) was 30% (23% to 57%) (P < 0.001). The score increased from 48% to 78% in intervention hospitals, while remaining the same in control hospitals (43%). A sub-analysis of 424 a priori identified critical criteria (19 service elements) showed significantly improved compliance with the critical standards (P < 0.001). The score increased from 41% (21% to 46%) to 75% (55% to 96%) in intervention hospitals, but was unchanged in control hospitals (37%). Only one of the nine intervention hospitals gained full accreditation status at the end of the study period, with two others reached pre-accreditation status.The median intervention effect (range) for the indicators of hospital quality of care was 2.4 (−1.9 to +11.8) and only one of the eight indicators: ‘nurses perception of clinical quality, participation and teamwork’ was significantly improved (mean intervention effect 5.7, P = 0.03). Re-analysis of the MRSA (methicillin-resistant Staphylococcus aureus) data showed statistically non-significant effects of the Healthcare Commissions Infection Inspection programme. Authors’ conclusions We only identified two studies for inclusion in this review, which highlights the paucity of high-quality controlled evaluations of the effectiveness of external inspection systems. No firm conclusions could therefore be drawn about the effectiveness of external inspection on compliance with standards. PMID:22071861

Comprehensive analysis of chemical constituents in Xingxiong injection by high performance liquid chromatography coupled with mass spectrometry.

PubMed

Guo, Long; Dou, Li-Li; Duan, Li; Liu, Ke; Bi, Zhi-Ming; Li, Ping; Liu, E-Hu

2015-09-01

Xingxiong injection (XXI) is a widely used Chinese herbal formula prepared by the folium ginkgo extract and ligustrazine for the treatment of cardiovascular and cerebrovascular diseases. Compared with the pharmacological studies, chemical analysis and quality control studies on this formula are relatively limited. In the present study, a high performance liquid chromatography coupled with quadrupole time-of-flight mass spectrometry (HPLC-QTOF MS) method was applied to comprehensive analysis of constituents in XXI. According to the fragmentation rules and previous reports, thirty ginkgo flavonoids, four ginkgo terpene lactones, and one alkaloid were identified. A high performance liquid chromatography coupled with triple quadrupole mass spectrometry (HPLC-QQQ MS) method was then applied to quantify ten major constituents in XXI. The method validation results indicated that the developed method had desirable specificity, linearity, precision and accuracy. The total contents of ginkgo flavonoids were about 22.05-25.51 μg·mL(-1) and the ginkgo terpene lactones amounts were about 4.41-8.70 μg·mL(-1) in six batches of XXI samples, respectively. Furthermore, cosine ratio algorithm and distance measurements were employed to evaluate the similarity of XXI samples, and the results demonstrated a high-quality consistency. This work could provide comprehensive information on the quality control of Xingxiong injection, which be helpful in the establishment of a rational quality control standard. Copyright © 2015 China Pharmaceutical University. Published by Elsevier B.V. All rights reserved.

Developing standards for malaria microscopy: external competency assessment for malaria microscopists in the Asia-Pacific.

PubMed

Ashraf, Sania; Kao, Angie; Hugo, Cecilia; Christophel, Eva M; Fatunmbi, Bayo; Luchavez, Jennifer; Lilley, Ken; Bell, David

2012-10-24

Malaria diagnosis has received renewed interest in recent years, associated with the increasing accessibility of accurate diagnosis through the introduction of rapid diagnostic tests and new World Health Organization guidelines recommending parasite-based diagnosis prior to anti-malarial therapy. However, light microscopy, established over 100 years ago and frequently considered the reference standard for clinical diagnosis, has been neglected in control programmes and in the malaria literature and evidence suggests field standards are commonly poor. Microscopy remains the most accessible method for parasite quantitation, for drug efficacy monitoring, and as a reference of assessing other diagnostic tools. This mismatch between quality and need highlights the importance of the establishment of reliable standards and procedures for assessing and assuring quality. This paper describes the development, function and impact of a multi-country microscopy external quality assurance network set up for this purpose in Asia. Surveys were used for key informants and past participants for feedback on the quality assurance programme. Competency scores for each country from 14 participating countries were compiled for analyses using paired sample t-tests. In-depth interviews were conducted with key informants including the programme facilitators and national level microscopists. External assessments and limited retraining through a formalized programme based on a reference slide bank has demonstrated an increase in standards of competence of senior microscopists over a relatively short period of time, at a potentially sustainable cost. The network involved in the programme now exceeds 14 countries in the Asia-Pacific, and the methods are extended to other regions. While the impact on national programmes varies, it has translated in some instances into a strengthening of national microscopy standards and offers a possibility both for supporting revival of national microcopy programmes, and for the development of globally recognized standards of competency needed both for patient management and field research.

EPA Method 1615. Measurement of Enterovirus and Norovirus Occurrence in Water by Culture and RT-qPCR. Part III. Virus Detection by RT-qPCR

PubMed Central

Fout, G. Shay; Cashdollar, Jennifer L.; Griffin, Shannon M.; Brinkman, Nichole E.; Varughese, Eunice A.; Parshionikar, Sandhya U.

2016-01-01

EPA Method 1615 measures enteroviruses and noroviruses present in environmental and drinking waters. This method was developed with the goal of having a standardized method for use in multiple analytical laboratories during monitoring period 3 of the Unregulated Contaminant Monitoring Rule. Herein we present the protocol for extraction of viral ribonucleic acid (RNA) from water sample concentrates and for quantitatively measuring enterovirus and norovirus concentrations using reverse transcription-quantitative PCR (RT-qPCR). Virus concentrations for the molecular assay are calculated in terms of genomic copies of viral RNA per liter based upon a standard curve. The method uses a number of quality controls to increase data quality and to reduce interlaboratory and intralaboratory variation. The method has been evaluated by examining virus recovery from ground and reagent grade waters seeded with poliovirus type 3 and murine norovirus as a surrogate for human noroviruses. Mean poliovirus recoveries were 20% in groundwaters and 44% in reagent grade water. Mean murine norovirus recoveries with the RT-qPCR assay were 30% in groundwaters and 4% in reagent grade water. PMID:26862985

International water and steam quality standards on thermal power plants at all-volatile treatment

NASA Astrophysics Data System (ADS)

Petrova, T. I.; Orlov, K. A.; Dooley, R. B.

2016-12-01

One of the methods for the improvement of reliability and efficiency of the equipment at heat power plants is the decrease in the rate of corrosion of structural materials and sedimentation in water/steam circuit. These processes can be reduced to minimum by using the water with low impurity content and coolant treatment. For many years, water and steam quality standards were developed in various countries (United States, Germany, Japan, etc.) for specific types of equipment. The International Association for the Properties of Water and Steam (IAPWS), which brings together specialists from 21 countries, developed the water and steam quality standards for various types of power equipment based on theoretical studies and long-term operating experience of power equipment. Recently, various water-chemistry conditions are applied on heatpower equipment including conventional boilers and HRSGs with combined cycle power plants (Combined Cycle Power Plants (CCPP)). In paper, the maintenance conditions of water chemistry with ammonia or volatile amine dosing are described: reducing AVT(R), oxidizing AVT(O), and oxygen OT. Each of them is provided by the water and steam quality standards and recommendations are given on their maintenance under various operation conditions. It is noted that the quality control of heat carrier must be carried out with a particular care on the HPPs with combined cycle gas turbine units, where frequent starts and halts are performed.

Meeting the requirements of importing countries: practice and policy for on-farm approaches to food safety.

PubMed

Dagg, P J; Butler, R J; Murray, J G; Biddle, R R

2006-08-01

In light of the increasing consumer demand for safe, high-quality food and recent public health concerns about food-borne illness, governments and agricultural industries are under pressure to provide comprehensive food safety policies and programmes consistent with international best practice. Countries that export food commodities derived from livestock must meet both the requirements of the importing country and domestic standards. It is internationally accepted that end-product quality control, and similar methods aimed at ensuring food safety, cannot adequately ensure the safety of the final product. To achieve an acceptable level of food safety, governments and the agricultural industry must work collaboratively to provide quality assurance systems, based on sound risk management principles, throughout the food supply chain. Quality assurance systems on livestock farms, as in other parts of the food supply chain, should address food safety using hazard analysis critical control point principles. These systems should target areas including biosecurity, disease monitoring and reporting, feedstuff safety, the safe use of agricultural and veterinary chemicals, the control of potential food-borne pathogens and traceability. They should also be supported by accredited training programmes, which award certification on completion, and auditing programmes to ensure that both local and internationally recognised guidelines and standards continue to be met. This paper discusses the development of policies for on-farm food safety measures and their practical implementation in the context of quality assurance programmes, using the Australian beef industry as a case study.

POTENTIAL RADIOACTIVE POLLUTANTS RESULTING FROM EXPANDED ENERGY PROGRAMS

EPA Science Inventory

An effective environmental monitoring program must have a quality assurance component to assure the production of valid data. Quality assurance has many components: calibration standards, standard reference materials, standard reference methods, interlaboratory comparison studies...

Microbiological quality of indoor air in university libraries.

PubMed

Hayleeyesus, Samuel Fekadu; Manaye, Abayneh Melaku

2014-05-01

To evaluate the concentration of bacteria and fungi in the indoor environment of Jimma University libraries, so as to estimate the health hazard and to create standards for indoor air quality control. The microbial quality of indoor air of eight libraries of Jimma University was determined. The settle plate method using open Petri-dishes containing different culture media was employed to collect sample twice daily. Isolates were identified according to standard methods. The concentrations of bacteria and fungi aerosols in the indoor environment of the university libraries ranged between 367-2595 CFU/m(3). According to the sanitary standards classification of European Commission, almost all the libraries indoor air of Jimma University was heavily contaminated with bacteria and fungi. In spite of their major source difference, the average fungi density found in the indoor air of libraries did appear to follow the same trend with bacterial density (P=0.001). The bacteria isolates included Micrococcus sp., Staphylococcus aureus, Streptococcus pyogenes, Bacillus sp. and Neisseria sp. while Cladosporium sp., Alternaria sp., Penicillium sp. and Aspergillus sp. were the most isolated fungi. The indoor air of all libraries were in the range above highly contaminated according to European Commission classification and the most isolates are considered as potential candidates involved in the establishment of sick building syndromes and often associated with clinical manifestations like allergy, rhinitis, asthma and conjunctivitis. Thus, attention must be given to control those environmental factors which favor the growth and multiplication of microbes in indoor environment of libraries to safeguard the health of users and workers.

A Spectral Method for Spatial Downscaling

PubMed Central

Reich, Brian J.; Chang, Howard H.; Foley, Kristen M.

2014-01-01

Summary Complex computer models play a crucial role in air quality research. These models are used to evaluate potential regulatory impacts of emission control strategies and to estimate air quality in areas without monitoring data. For both of these purposes, it is important to calibrate model output with monitoring data to adjust for model biases and improve spatial prediction. In this article, we propose a new spectral method to study and exploit complex relationships between model output and monitoring data. Spectral methods allow us to estimate the relationship between model output and monitoring data separately at different spatial scales, and to use model output for prediction only at the appropriate scales. The proposed method is computationally efficient and can be implemented using standard software. We apply the method to compare Community Multiscale Air Quality (CMAQ) model output with ozone measurements in the United States in July 2005. We find that CMAQ captures large-scale spatial trends, but has low correlation with the monitoring data at small spatial scales. PMID:24965037

Rapid analysis of Aurantii Fructus Immaturus (Zhishi) using paper spray ionization mass spectrometry.

PubMed

Liu, Xuemei; Gu, Zhixin; Guo, Yuan; Liu, Jingjing; Ma, Ming; Chen, Bo; Wang, Liping

2017-04-15

Paper spray-mass spectrometry (PS-MS) is a rapid, solvent-efficient, and high-throughput analytical method for analyzing complex samples. In this study, a PS-MS method was developed to obtain MS profiles of Aurantii Fructus Immaturus (aka Zhishi in Chinese) in positive and negative ion modes. In combination with multivariate analyses, including principal component analysis and cluster analysis, the PS-MS profiles of 25 batches of Zhishi were discriminated in 25 batches of Citri Reticulatae Pericarpium Viride (aka Qingpi in Chinese; an adulterant of Zhishi). Moreover, a rapid quantitative analysis of synephrine, a prescriptive quality control component of Zhishi listed in the Chinese Pharmacopoeia, was conducted with PS-MS using synephrine-d2 as an internal standard (IS). The linearity range was 1.68-16.8μg/mL (R 2 =0.9985), the limit of quantitation was 0.5μg/mL. Relative standard deviations in the intra- and inter-day precision of the MS were 4.87 and 4.90%, respectively. Compared with HPLC results, there was no significant difference in the quantitation of synephrine. This study demonstrated that the PS-MS method is useful for the rapid discrimination and quality control of Zhishi samples. Copyright © 2017 Elsevier B.V. All rights reserved.

Normative standards for wildlife viewing in parks and protected areas

Treesearch

Laura Anderson; Robert Manning; William Valliere; Jeffrey Hallo

2010-01-01

With increasing public interest in wildlife watching, there is a need to develop methods to inform the management of high-quality viewing opportunities. In this study, normative methods using indicators and standards of quality were applied at a national park in Alaska and a wildlife refuge in New Hampshire. Four potential indicators of quality are identified that can...

Comparative mass spectrometry & nuclear magnetic resonance metabolomic approaches for nutraceuticals quality control analysis: a brief review.

PubMed

Farag, Mohamed A

2014-01-01

The number of botanical dietary supplements in the market has recently increased primarily due to increased health awareness. Standardization and quality control of the constituents of these plant extracts is an important topic, particularly when such ingredients are used long term as dietary supplements, or in cases where higher doses are marketed as drugs. The development of fast, comprehensive, and effective untargeted analytical methods for plant extracts is of high interest. Nuclear magnetic resonance spectroscopy and mass spectrometry are the most informative tools, each of which enables high-throughput and global analysis of hundreds of metabolites in a single step. Although only one of the two techniques is utilized in the majority of plant metabolomics applications, there is a growing interest in combining the data from both platforms to effectively unravel the complexity of plant samples. The application of combined MS and NMR in the quality control of nutraceuticals forms the major part of this review. Finally I will look at the future developments and perspectives of these two technologies for the quality control of herbal materials.

Method of fabricating optical waveguides by ion implantation doping

DOEpatents

Appleton, Bill R.; Ashley, Paul R.; Buchal, Christopher J.

1989-01-01

A method for fabricating high-quality optical waveguides in optical quality oxide crystals by ion implantation doping and controlled epitaxial recrystallization is provided. Masked LiNbO.sub.3 crystals are implanted with high concentrations of Ti dopant at ion energies of about 350 keV while maintaining the crystal near liquid nitrogen temperature. Ion implantation doping produces an amorphous, Ti-rich nonequilibrium phase in the implanted region. Subsequent thermal annealing in a water-saturated oxygen atmosphere at up to 1000.degree. C. produces solid-phase epitaxial regrowth onto the crystalline substrate. A high-quality single crystalline layer results which incorporates the Ti into the crystal structure at much higher concentrations than is possible by standard diffusion techniques, and this implanted region has excellent optical waveguides properties.

[Thinking on designation of sham acupuncture in clinical research].

PubMed

Pan, Li-Jia; Chen, Bo; Zhao, Xue; Guo, Yi

2014-01-01

Randomized controlled trials (RCT) is the source of the raw data of evidence-based medicine. Blind method is adopted in most of the high-quality RCT. Sham acupuncture is the main form of blinded in acupuncture clinical trial. In order to improve the quality of acupuncture clinical trail, based on the necessity of sham acupuncture in clinical research, the current situation as well as the existing problems of sham acupuncture, suggestions were put forward from the aspects of new way and new designation method which can be adopted as reference, and factors which have to be considered during the process of implementing. Various subjective and objective factors involving in the process of trial should be considered, and used of the current international standards, try to be quantification, and carry out strict quality monitoring.

Investigation of priorities in water quality management based on correlations and variations.

PubMed

Boyacıoğlu, Hülya; Gündogdu, Vildan; Boyacıoğlu, Hayal

2013-04-15

The development of water quality assessment strategies investigating spatial and temporal changes caused by natural and anthropogenic phenomena is an important tool in management practices. This paper used cluster analysis, water quality index method, sensitivity analysis and canonical correlation analysis to investigate priorities in pollution control activities. Data sets representing 22 surface water quality parameters were subject to analysis. Results revealed that organic pollution was serious threat for overall water quality in the region. Besides, oil and grease, lead and mercury were the critical variables violating the standard. In contrast to inorganic variables, organic and physical-inorganic chemical parameters were influenced by variations in physical conditions (discharge, temperature). This study showed that information produced based on the variations and correlations in water quality data sets can be helpful to investigate priorities in water management activities. Moreover statistical techniques and index methods are useful tools in data - information transformation process. Copyright © 2013 Elsevier Ltd. All rights reserved.

33 CFR 337.8 - Reports to higher echelons.

Code of Federal Regulations, 2010 CFR

2010-07-01

... quality certification or issues the certification with conditions or controls not related to maintenance or enforcement of state water quality standards or significantly exceeding the Federal standard; (5... regional administrator's objections; and (6) When the state fails to grant water quality certification or a...

33 CFR 337.8 - Reports to higher echelons.

Code of Federal Regulations, 2013 CFR

2013-07-01

... quality certification or issues the certification with conditions or controls not related to maintenance or enforcement of state water quality standards or significantly exceeding the Federal standard; (5... regional administrator's objections; and (6) When the state fails to grant water quality certification or a...

33 CFR 337.8 - Reports to higher echelons.

Code of Federal Regulations, 2012 CFR

2012-07-01

... quality certification or issues the certification with conditions or controls not related to maintenance or enforcement of state water quality standards or significantly exceeding the Federal standard; (5... regional administrator's objections; and (6) When the state fails to grant water quality certification or a...

33 CFR 337.8 - Reports to higher echelons.

Code of Federal Regulations, 2011 CFR

2011-07-01

... quality certification or issues the certification with conditions or controls not related to maintenance or enforcement of state water quality standards or significantly exceeding the Federal standard; (5... regional administrator's objections; and (6) When the state fails to grant water quality certification or a...

Orthogonal analytical methods for botanical standardization: Determination of green tea catechins by qNMR and LC-MS/MS

PubMed Central

Napolitano, José G.; Gödecke, Tanja; Lankin, David C.; Jaki, Birgit U.; McAlpine, James B.; Chen, Shao-Nong; Pauli, Guido F.

2013-01-01

The development of analytical methods for parallel characterization of multiple phytoconstituents is essential to advance the quality control of herbal products. While chemical standardization is commonly carried out by targeted analysis using gas or liquid chromatography-based methods, more universal approaches based on quantitative 1H NMR (qHNMR) measurements are being used increasingly in the multi-targeted assessment of these complex mixtures. The present study describes the development of a 1D qHNMR-based method for simultaneous identification and quantification of green tea constituents. This approach utilizes computer-assisted 1H iterative Full Spin Analysis (HiFSA) and enables rapid profiling of seven catechins in commercial green tea extracts. The qHNMR results were cross-validated against quantitative profiles obtained with an orthogonal LC-MS/MS method. The relative strengths and weaknesses of both approaches are discussed, with special emphasis on the role of identical reference standards in qualitative and quantitative analyses. PMID:23870106

A direct sensitivity approach to predict hourly ozone resulting from compliance with the National Ambient Air Quality Standard.

PubMed

Simon, Heather; Baker, Kirk R; Akhtar, Farhan; Napelenok, Sergey L; Possiel, Norm; Wells, Benjamin; Timin, Brian

2013-03-05

In setting primary ambient air quality standards, the EPA's responsibility under the law is to establish standards that protect public health. As part of the current review of the ozone National Ambient Air Quality Standard (NAAQS), the US EPA evaluated the health exposure and risks associated with ambient ozone pollution using a statistical approach to adjust recent air quality to simulate just meeting the current standard level, without specifying emission control strategies. One drawback of this purely statistical concentration rollback approach is that it does not take into account spatial and temporal heterogeneity of ozone response to emissions changes. The application of the higher-order decoupled direct method (HDDM) in the community multiscale air quality (CMAQ) model is discussed here to provide an example of a methodology that could incorporate this variability into the risk assessment analyses. Because this approach includes a full representation of the chemical production and physical transport of ozone in the atmosphere, it does not require assumed background concentrations, which have been applied to constrain estimates from past statistical techniques. The CMAQ-HDDM adjustment approach is extended to measured ozone concentrations by determining typical sensitivities at each monitor location and hour of the day based on a linear relationship between first-order sensitivities and hourly ozone values. This approach is demonstrated by modeling ozone responses for monitor locations in Detroit and Charlotte to domain-wide reductions in anthropogenic NOx and VOCs emissions. As seen in previous studies, ozone response calculated using HDDM compared well to brute-force emissions changes up to approximately a 50% reduction in emissions. A new stepwise approach is developed here to apply this method to emissions reductions beyond 50% allowing for the simulation of more stringent reductions in ozone concentrations. Compared to previous rollback methods, this application of modeled sensitivities to ambient ozone concentrations provides a more realistic spatial response of ozone concentrations at monitors inside and outside the urban core and at hours of both high and low ozone concentrations.

REM desensitization as a new therapeutic method for post-traumatic stress disorder: a randomized controlled trial.

PubMed

Ahmadi, Khodabakhsh; Hazrati, Majid; Ahmadizadeh, Mohammadjavad; Noohi, Sima

2015-04-01

to evaluate potential efficacy of a new therapeutic approach in posttraumatic stress disorder in comparison with eye movement desensitization and reprocessing (EMDR), a standard treatment approach and controls. the study was designed using a randomized controlled trial methodology. Participants were recruited from military servicemen aged between 25 to 50 years who were admitting hospitals of Bushehr, Iran, with the final diagnosis of PTSD. Finally 33 male patients were devided into three subgroups: G1: EMDR; G2: REM Desensitization; and group 3: controls who received no therapy. Mississippi Scale for Posttraumatic Stress Disorder, Pittsburgh Sleep Quality Index (PSQI) and a 37 item death anxiety questionnaire were used for measures. multiple comparisons showed that intrusive thoughts were significantly more likely to improve with REM Desensitization versus EMDR (P=0.03), while depression was more responsive to EMDR (p=0.03). Among the Pittsburgh scale for the quality of sleep items, sleep quality (p=0.02), sleep duration (p=0.001), and total sleep quality score (p=0.002) were significantly more likely to improve in the REM Desensitization group. Change in the absolute death anxiety scores was not different between subgroups excepting EMDR versus control group (p=0.05). REM, desensitization, the new therapeutic approach to PTSD is a highly effective strategy, even more than EMDR, the standard treatment, in most of the evaluated subjects, with special emphasis on sleep symptoms, and also in the management of intrusive thoughts. Depression is the only factor in which, REM Desensitization was significantly less likely to represent a superior therapeutic effect than EMDR.

Issues concerning international comparison of free-field calibrations of acoustical standards

NASA Astrophysics Data System (ADS)

Nedzelnitsky, Victor

2002-11-01

Primary free-field calibrations of laboratory standard microphones by the reciprocity method establish these microphones as reference standard devices for calibrating working standard microphones, other measuring microphones, and practical instruments such as sound level meters and personal sound exposure meters (noise dosimeters). These primary, secondary, and other calibrations are indispensable to the support of regulatory requirements, standards, and product characterization and quality control procedures important for industry, commerce, health, and safety. International Electrotechnical Commission (IEC) Technical Committee 29 Electroacoustics produces international documentary standards, including standards for primary and secondary free-field calibration and measurement procedures and their critically important application to practical instruments. This paper addresses some issues concerning calibrations, standards activities, and the international key comparison of primary free-field calibrations of IEC-type LS2 laboratory standard microphones that is being planned by the Consultative Committee for Acoustics, Ultrasound, and Vibration (CCAUV) of the International Committee for Weights and Measures (CIPM). This comparison will include free-field calibrations by the reciprocity method at participating major national metrology laboratories throughout the world.

U.S. Geological Survey Standard Reference Sample Project: Performance Evaluation of Analytical Laboratories

USGS Publications Warehouse

Long, H. Keith; Daddow, Richard L.; Farrar, Jerry W.

1998-01-01

Since 1962, the U.S. Geological Survey (USGS) has operated the Standard Reference Sample Project to evaluate the performance of USGS, cooperator, and contractor analytical laboratories that analyze chemical constituents of environmental samples. The laboratories are evaluated by using performance evaluation samples, called Standard Reference Samples (SRSs). SRSs are submitted to laboratories semi-annually for round-robin laboratory performance comparison purposes. Currently, approximately 100 laboratories are evaluated for their analytical performance on six SRSs for inorganic and nutrient constituents. As part of the SRS Project, a surplus of homogeneous, stable SRSs is maintained for purchase by USGS offices and participating laboratories for use in continuing quality-assurance and quality-control activities. Statistical evaluation of the laboratories results provides information to compare the analytical performance of the laboratories and to determine possible analytical deficiences and problems. SRS results also provide information on the bias and variability of different analytical methods used in the SRS analyses.

Traffic Data Quality Measurement : Final Report

DOT National Transportation Integrated Search

2004-09-15

One of the foremost recommendations from the FHWA sponsored workshops on Traffic Data Quality (TDQ) in 2003 was a call for "guidelines and standards for calculating data quality measures." These guidelines and standards are expected to contain method...

Natural Language Processing-Enabled and Conventional Data Capture Methods for Input to Electronic Health Records: A Comparative Usability Study.

PubMed

Kaufman, David R; Sheehan, Barbara; Stetson, Peter; Bhatt, Ashish R; Field, Adele I; Patel, Chirag; Maisel, James Mark

2016-10-28

The process of documentation in electronic health records (EHRs) is known to be time consuming, inefficient, and cumbersome. The use of dictation coupled with manual transcription has become an increasingly common practice. In recent years, natural language processing (NLP)-enabled data capture has become a viable alternative for data entry. It enables the clinician to maintain control of the process and potentially reduce the documentation burden. The question remains how this NLP-enabled workflow will impact EHR usability and whether it can meet the structured data and other EHR requirements while enhancing the user's experience. The objective of this study is evaluate the comparative effectiveness of an NLP-enabled data capture method using dictation and data extraction from transcribed documents (NLP Entry) in terms of documentation time, documentation quality, and usability versus standard EHR keyboard-and-mouse data entry. This formative study investigated the results of using 4 combinations of NLP Entry and Standard Entry methods ("protocols") of EHR data capture. We compared a novel dictation-based protocol using MediSapien NLP (NLP-NLP) for structured data capture against a standard structured data capture protocol (Standard-Standard) as well as 2 novel hybrid protocols (NLP-Standard and Standard-NLP). The 31 participants included neurologists, cardiologists, and nephrologists. Participants generated 4 consultation or admission notes using 4 documentation protocols. We recorded the time on task, documentation quality (using the Physician Documentation Quality Instrument, PDQI-9), and usability of the documentation processes. A total of 118 notes were documented across the 3 subject areas. The NLP-NLP protocol required a median of 5.2 minutes per cardiology note, 7.3 minutes per nephrology note, and 8.5 minutes per neurology note compared with 16.9, 20.7, and 21.2 minutes, respectively, using the Standard-Standard protocol and 13.8, 21.3, and 18.7 minutes using the Standard-NLP protocol (1 of 2 hybrid methods). Using 8 out of 9 characteristics measured by the PDQI-9 instrument, the NLP-NLP protocol received a median quality score sum of 24.5; the Standard-Standard protocol received a median sum of 29; and the Standard-NLP protocol received a median sum of 29.5. The mean total score of the usability measure was 36.7 when the participants used the NLP-NLP protocol compared with 30.3 when they used the Standard-Standard protocol. In this study, the feasibility of an approach to EHR data capture involving the application of NLP to transcribed dictation was demonstrated. This novel dictation-based approach has the potential to reduce the time required for documentation and improve usability while maintaining documentation quality. Future research will evaluate the NLP-based EHR data capture approach in a clinical setting. It is reasonable to assert that EHRs will increasingly use NLP-enabled data entry tools such as MediSapien NLP because they hold promise for enhancing the documentation process and end-user experience. ©David R. Kaufman, Barbara Sheehan, Peter Stetson, Ashish R. Bhatt, Adele I. Field, Chirag Patel, James Mark Maisel. Originally published in JMIR Medical Informatics (http://medinform.jmir.org), 28.10.2016.

Evaluation of Chilling Injury in Mangoes Using Multispectral Imaging.

PubMed

Hashim, Norhashila; Onwude, Daniel I; Osman, Muhamad Syafiq

2018-05-01

Commodities originating from tropical and subtropical climes are prone to chilling injury (CI). This injury could affect the quality and marketing potential of mango after harvest. This will later affect the quality of the produce and subsequent consumer acceptance. In this study, the appearance of CI symptoms in mango was evaluated non-destructively using multispectral imaging. The fruit were stored at 4 °C to induce CI and 12 °C to preserve the quality of the control samples for 4 days before they were taken out and stored at ambient temperature for 24 hr. Measurements using multispectral imaging and standard reference methods were conducted before and after storage. The performance of multispectral imaging was compared using standard reference properties including moisture content (MC), total soluble solids (TSS) content, firmness, pH, and color. Least square support vector machine (LS-SVM) combined with principal component analysis (PCA) were used to discriminate CI samples with those of control and before storage, respectively. The statistical results demonstrated significant changes in the reference quality properties of samples before and after storage. The results also revealed that multispectral parameters have a strong correlation with the reference parameters of L * , a * , TSS, and MC. The MC and L * were found to be the best reference parameters in identifying the severity of CI in mangoes. PCA and LS-SVM analysis indicated that the fruit were successfully classified into their categories, that is, before storage, control, and CI. This indicated that the multispectral imaging technique is feasible for detecting CI in mangoes during postharvest storage and processing. This paper demonstrates a fast, easy, and accurate method of identifying the effect of cold storage on mango, nondestructively. The method presented in this paper can be used industrially to efficiently differentiate different fruits from each other after low temperature storage. © 2018 Institute of Food Technologists®.

WELDSMART: A vision-based expert system for quality control

NASA Technical Reports Server (NTRS)

Andersen, Kristinn; Barnett, Robert Joel; Springfield, James F.; Cook, George E.

1992-01-01

This work was aimed at exploring means for utilizing computer technology in quality inspection and evaluation. Inspection of metallic welds was selected as the main application for this development and primary emphasis was placed on visual inspection, as opposed to other inspection methods, such as radiographic techniques. Emphasis was placed on methodologies with the potential for use in real-time quality control systems. Because quality evaluation is somewhat subjective, despite various efforts to classify discontinuities and standardize inspection methods, the task of using a computer for both inspection and evaluation was not trivial. The work started out with a review of the various inspection techniques that are used for quality control in welding. Among other observations from this review was the finding that most weld defects result in abnormalities that may be seen by visual inspection. This supports the approach of emphasizing visual inspection for this work. Quality control consists of two phases: (1) identification of weld discontinuities (some of which may be severe enough to be classified as defects), and (2) assessment or evaluation of the weld based on the observed discontinuities. Usually the latter phase results in a pass/fail judgement for the inspected piece. It is the conclusion of this work that the first of the above tasks, identification of discontinuities, is the most challenging one. It calls for sophisticated image processing and image analysis techniques, and frequently ad hoc methods have to be developed to identify specific features in the weld image. The difficulty of this task is generally not due to limited computing power. In most cases it was found that a modest personal computer or workstation could carry out most computations in a reasonably short time period. Rather, the algorithms and methods necessary for identifying weld discontinuities were in some cases limited. The fact that specific techniques were finally developed and successfully demosntrated to work illustrates that the general approach taken here appears to be promising for commercial development of computerized quality inspection systems. Inspection based on these techniques may be used to supplement or substitute more elaborate inspection methods, such as x-ray inspections.

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

PubMed

Yazawa, Naoyuki

2006-11-01

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

The Relationship between Social Capital and Quality Management Systems in European Hospitals: A Quantitative Study

PubMed Central

Hammer, Antje; Arah, Onyebuchi A.; DerSarkissian, Maral; Thompson, Caroline A.; Mannion, Russell; Wagner, Cordula; Ommen, Oliver; Sunol, Rosa; Pfaff, Holger

2013-01-01

Background Strategic leadership is an important organizational capability and is essential for quality improvement in hospital settings. Furthermore, the quality of leadership depends crucially on a common set of shared values and mutual trust between hospital management board members. According to the concept of social capital, these are essential requirements for successful cooperation and coordination within groups. Objectives We assume that social capital within hospital management boards is an important factor in the development of effective organizational systems for overseeing health care quality. We hypothesized that the degree of social capital within the hospital management board is associated with the effectiveness and maturity of the quality management system in European hospitals. Methods We used a mixed-method approach to data collection and measurement in 188 hospitals in 7 European countries. For this analysis, we used responses from hospital managers. To test our hypothesis, we conducted a multilevel linear regression analysis of the association between social capital and the quality management system score at the hospital level, controlling for hospital ownership, teaching status, number of beds, number of board members, organizational culture, and country clustering. Results The average social capital score within a hospital management board was 3.3 (standard deviation: 0.5; range: 1-4) and the average hospital score for the quality management index was 19.2 (standard deviation: 4.5; range: 0-27). Higher social capital was associated with higher quality management system scores (regression coefficient: 1.41; standard error: 0.64, p=0.029). Conclusion The results suggest that a higher degree of social capital exists in hospitals that exhibit higher maturity in their quality management systems. Although uncontrolled confounding and reverse causation cannot be completely ruled out, our new findings, along with the results of previous research, could have important implications for the work of hospital managers and the design and evaluation of hospital quality management systems. PMID:24392027

British Thoracic Society Quality Standards for acute non-invasive ventilation in adults

PubMed Central

Davies, Michael; Allen, Martin; Bentley, Andrew; Bourke, Stephen C; Creagh-Brown, Ben; D’Oliveiro, Rachel; Glossop, Alastair; Gray, Alasdair; Jacobs, Phillip; Mahadeva, Ravi; Moses, Rachael; Setchfield, Ian

2018-01-01

Introduction The purpose of the quality standards document is to provide healthcare professionals, commissioners, service providers and patients with a guide to standards of care that should be met for the provision of acute non-invasive ventilation in adults together with measurable markers of good practice. Methods Development of British Thoracic Society (BTS) Quality Standards follows the BTS process of quality standard production based on the National Institute for Health and Care Excellence process manual for the development of quality standards. Results 6 quality statements have been developed, each describing a standard of care for the provision of acute non-invasive ventilation in the UK, together with measurable markers of good practice. Conclusion BTS Quality Standards for acute non-invasive ventilation in adults form a key part of the range of supporting materials that the Society produces to assist in the dissemination and implementation of guideline’s recommendations. PMID:29636979

76 FR 23809 - Science Advisory Board Staff Office Notification of a Public Meeting of the Clean Air Scientific...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-28

...: Scope and Methods Plan for Welfare Risk and Exposure Assessment (April 2011 Draft). DATES: The CASAC... Ambient Air Quality Standards: Scope and Methods Plan for Health Risk and Exposure Assessment (April 2011), and Ozone National Ambient Air Quality Standards: Scope and Methods Plan for Welfare Risk and Exposure...

Success, failures and costs of implementing standards in the USA--lessons for infection control.

PubMed

McGowan, J E

1995-06-01

In the US, extensive standards for performance and 'guidelines for practice' have been instituted by a number of governmental and non-governmental agencies. New governmental plans for health care depend heavily on practice guidelines, and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has been especially enthusiastic about continuous quality improvement. Monitoring the appropriateness of care and altering physician practice appeals to insurance carriers and health care management organizations. Some initial data exist to show that the quality of health care has been enhanced by these regulations. The total cost for health care administration in 1990 in the USA was 24.8% of each hospital's spending for health care. Much of this was associated with spending for new initiatives in practice guidelines, physician profiling, quality assurance, and the like. Few data exist to show that the quality of health care or hospital infection control has been enhanced by these expenditures. Regulations and guidelines also have proliferated in infection control. Guides from the JCAHO have been expanded, and recent mandates from the Occupational Health and Safety Administration (OSHA) for protecting employees from blood-borne and respiratory pathogens promise to be especially costly for health care organizations to implement. Little data exist to show that the quality of infection control has been enhanced by these regulations. Standards are difficult to develop, because the science to back them up often is lacking, interpretation of validating data is imprecise, and inherent biological variation makes exceptions common. Seven lessons are important for those developing standards today. These include focusing on objective measures of the impact of the standard, clearly indicating the degree of scientific validity, making the development process inclusive, allowing for local variation, making sure that funding is provided for mandated standards, considering non-scientific implications of standards, and remaining involved in the process after the guideline is developed. Infection control workers should make sure that standards developed take the lessons above into account before they are promulgated.

Simultaneous Determination of Ten Constituents in Chaiqin Qingning Capsule by High-performance Liquid Chromatography Coupled with Triple-quadrupole Mass Spectrometry

PubMed Central

Li, Ting Yu; Huo, Xiao Kui; Zheng, Lu; Wang, Chao; Cong, Hai Jian; Xiang, Ting; Zhang, Lin; Zhang, Bao Jing; Huang, Shan Shan; Wu, Bin; Li, Xin Yu

2017-01-01

Background: Chaiqin Qingning Capsule (CQQNC) was a prescription of Traditional Chinese Medicine with the effects of clearing away heat and removing toxin, harmonizing the exterior and interior, it was widely used in Asian, for example, China and Japan, different batches of the raws materials and different processing time may be the vital factor which raised a challenge to control the quality of the CQQNC. Experimental Methods: In this experiment, a high-performance liquid chromatography-mass spectrometry/MS (HPLC-MS/MS) method was developed to simultaneously determine ten bioactive components for the quality control of CQQNC. Chromatographic separation was achieved using an XBridge BEH C18 column (150 mm × 4.6 mm, 2.5 μm) with a mobile phase composed of 10 mm aqueous ammonium acetate and acetonitrile using a gradient elution in 20 min. This study was conducted by multiple reaction monitoring mode through electrospray ionization resource with a negative ionization mode. Results: The established method was validated with good performance of precision, accuracy, stability, and reproducibility and was utilized to simultaneously quantify ten constituents of CQQNC obtained from seven different batches. Conclusion: It is the first time to report the rapid and simultaneous analysis of the ten compounds in CQQNC by HPLC-MS/MS and apply to determine 10 constituents in 7 batches of CQQNC bought from drug store in china. This method could be considered as good quality criteria to control the quality of CQQNC. SUMMARY In this paper, a simple, specific, and rapid high-performance liquid chromatogram coupled with triple-quadrupole mass spectrometry method for simultaneous quantification of ten constituents in Chaiqin Qingning Capsule has been developed for the first time. This method could be considered as good quality criteria to control the quality of CQQNC. Abbreviations used: CHM: Chinese herbal medicine; TCM: Traditional Chinese Medicine; CQQNC: Triple-quadrupole mass spectrometry Chaiqin Qingning Capsules; HPLC–MS/MS: High liquid chromatography equipped with tandem mass spectrometry; ESI: Electrospray ionization; DP: Declustering potential; CE: Collision energy; RSD: Relative standard deviation; LOD: Limit of detection; LOQ: Limit of quantity. PMID:29200714

[Air quality control systems: heating, ventilating, and air conditioning (HVAC)].

PubMed

Bellucci Sessa, R; Riccio, G

2004-01-01

After a brief illustration of the principal layout schemes of Heating, Ventilating, and Air Conditioning (HVAC), the first part of this paper summarizes the standards, both voluntary and compulsory, regulating HVAC facilities design and installation with regard to the question of Indoor Air Quality (IAQ). The paper then examines the problem of ventilation systems maintenance and the essential hygienistic requirements in whose absence HVAC facilities may become a risk factor for people working or living in the building. Lastly, the paper deals with HVAC design strategies and methods, which aim not only to satisfy comfort and air quality requirements, but also to ensure easy and effective maintenance procedures.

Multi response optimization of internal grinding process parameters for outer ring using Taguchi method and PCR-TOPSIS

NASA Astrophysics Data System (ADS)

Wisnuadi, Alief Regyan; Damayanti, Retno Wulan; Pujiyanto, Eko

2018-02-01

Bearing is one of the most widely used parts in automotive industry. One of the leading bearing manufacturing companies in the world is SKF Indonesia. This company must produce bearing with international standard. SKF Indonesia must do continuous improvement in order to face competition. During this time, SKF Indonesia is only performing quality control at its Quality Assurance department. In other words, quality improvement at SKF Indonesia has not been done thoroughly. The purpose of this research is to improve quality of outer ring product at SKF Indonesia by conducting an internal grinding process experiment about setting speed ratio, fine position, and spark out grinding time. The specific purpose of this experiment is to optimize some quality responses such as roughness, roundness, and cycle time. All of the response in this experiment were smaller the better. Taguchi method and PCR-TOPSIS are used for the optimization process. The result of this research shows that by using Taguchi method and PCR-TOPSIS, the optimum condition occurs on speed ratio 36, fine position 18 µm/s and spark out 0.5 s. The optimum conditions result were roughness 0.398 µm, roundness 1.78 µm and cycle time 8.1 s. This results have been better than the previous results and meet the standards. The roughness of 0.523 µm decrease to 0.398 µm and the average cycle time of 8.5 s decrease to 8.1 s.

Validation of analytical methods in GMP: the disposable Fast Read 102® device, an alternative practical approach for cell counting

PubMed Central

2012-01-01

Background The quality and safety of advanced therapy products must be maintained throughout their production and quality control cycle to ensure their final use in patients. We validated the cell count method according to the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use and European Pharmacopoeia, considering the tests’ accuracy, precision, repeatability, linearity and range. Methods As the cell count is a potency test, we checked accuracy, precision, and linearity, according to ICH Q2. Briefly our experimental approach was first to evaluate the accuracy of Fast Read 102® compared to the Bürker chamber. Once the accuracy of the alternative method was demonstrated, we checked the precision and linearity test only using Fast Read 102®. The data were statistically analyzed by average, standard deviation and coefficient of variation percentages inter and intra operator. Results All the tests performed met the established acceptance criteria of a coefficient of variation of less than ten percent. For the cell count, the precision reached by each operator had a coefficient of variation of less than ten percent (total cells) and under five percent (viable cells). The best range of dilution, to obtain a slope line value very similar to 1, was between 1:8 and 1:128. Conclusions Our data demonstrated that the Fast Read 102® count method is accurate, precise and ensures the linearity of the results obtained in a range of cell dilution. Under our standard method procedures, this assay may thus be considered a good quality control method for the cell count as a batch release quality control test. Moreover, the Fast Read 102® chamber is a plastic, disposable device that allows a number of samples to be counted in the same chamber. Last but not least, it overcomes the problem of chamber washing after use and so allows a cell count in a clean environment such as that in a Cell Factory. In a good manufacturing practice setting the disposable cell counting devices will allow a single use of the count chamber they can then be thrown away, thus avoiding the waste disposal of vital dye (e.g. Trypan Blue) or lysing solution (e.g. Tuerk solution). PMID:22650233

[Implementation of quality standard UNE-EN ISO/IEC 17043 in the External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology].

PubMed

Poveda Gabaldón, Marta; Ovies, María Rosario; Orta Mira, Nieves; Serrano, M del Remedio Guna; Avila, Javier; Giménez, Alicia; Cardona, Concepción Gimeno

2011-12-01

The quality standard "UNE-EN-ISO 17043: 2010. Conformity assessment. General requirements for proficiency testing" applies to centers that organize intercomparisons in all areas. In the case of clinical microbiology laboratories, these intercomparisons must meet the management and technical standards required to achieve maximum quality in the performance of microbiological analysis and the preparation of test items (sample, product, data or other information used in the proficiency test) to enable them to be accredited. Once accredited, these laboratories can operate as a tool for quality control laboratories and competency assessment. In Spain, accreditation is granted by the Spanish Accreditation Body [Entidad Nacional de Acreditación (ENAC)]. The objective of this review is to explain how to apply the requirements of the standard to laboratories providing intercomparisons in the field of clinical microbiology (the organization responsible for all the tasks related to the development and operation of a proficiency testing program). This requires defining the scope and specifying the technical requirements (personnel management, control of equipment, facilities and environment, the design of the proficiency testing and data analysis for performance evaluation, communication with participants and confidentiality) and management requirements (document control, purchasing control, monitoring of complaints / claims, non-compliance, internal audits and management reviews). Copyright © 2011 Elsevier España S.L. All rights reserved.

Evaluation of external RNA controls for the standardisation of gene expression biomarker measurements.

PubMed

Devonshire, Alison S; Elaswarapu, Ramnath; Foy, Carole A

2010-11-24

Gene expression profiling is an important approach for detecting diagnostic and prognostic biomarkers, and predicting drug safety. The development of a wide range of technologies and platforms for measuring mRNA expression makes the evaluation and standardization of transcriptomic data problematic due to differences in protocols, data processing and analysis methods. Thus, universal RNA standards, such as those developed by the External RNA Controls Consortium (ERCC), are proposed to aid validation of research findings from diverse platforms such as microarrays and RT-qPCR, and play a role in quality control (QC) processes as transcriptomic profiling becomes more commonplace in the clinical setting. Panels of ERCC RNA standards were constructed in order to test the utility of these reference materials (RMs) for performance characterization of two selected gene expression platforms, and for discrimination of biomarker profiles between groups. The linear range, limits of detection and reproducibility of microarray and RT-qPCR measurements were evaluated using panels of RNA standards. Transcripts of low abundance (≤ 10 copies/ng total RNA) showed more than double the technical variability compared to higher copy number transcripts on both platforms. Microarray profiling of two simulated 'normal' and 'disease' panels, each consisting of eight different RNA standards, yielded robust discrimination between the panels and between standards with varying fold change ratios, showing no systematic effects due to different labelling and hybridization runs. Also, comparison of microarray and RT-qPCR data for fold changes showed agreement for the two platforms. ERCC RNA standards provide a generic means of evaluating different aspects of platform performance, and can provide information on the technical variation associated with quantification of biomarkers expressed at different levels of physiological abundance. Distinct panels of standards serve as an ideal quality control tool kit for determining the accuracy of fold change cut-off threshold and the impact of experimentally-derived noise on the discrimination of normal and disease profiles.

Electron tubes for industrial applications

NASA Astrophysics Data System (ADS)

Gellert, Bernd

1994-05-01

This report reviews research and development efforts within the last years for vacuum electron tubes, in particular power grid tubes for industrial applications. Physical and chemical effects are discussed that determine the performance of todays devices. Due to the progress made in the fundamental understanding of materials and newly developed processes the reliability and reproducibility of power grid tubes could be improved considerably. Modern computer controlled manufacturing methods ensure a high reproducibility of production and continuous quality certification according to ISO 9001 guarantees future high quality standards. Some typical applications of these tubes are given as an example.

The quality of sputum smear microscopy in public-private mix directly observed treatment laboratories in West Amhara region, Ethiopia.

PubMed

Manalebh, Almaw; Demissie, Meaza; Mekonnen, Daniel; Abera, Bayeh

2015-01-01

Ethiopia adopted Public-Private Mix Directly Observed Treatment Short Course Chemotherapy (PPM-DOTS) strategy for tuberculosis (TB) control program. Quality of sputum smear microscopy has paramount importance for tuberculosis control program in resource-poor countries like Ethiopia. A cross-sectional study was conducted to assess the quality of sputum smear microscopy in 37 Public-Private Mix laboratories in West Amhara, Ethiopia. The three external quality assessment methods (onsite evaluation, panel testing and blind rechecking) were employed. Onsite assessment revealed that 67.6% of PPM-DOTS laboratories were below the standard physical space (5 X 6) m2. The average monthly workload per laboratory technician was 19.5 (SD±2.9) slides with 12.8% positivity rate. The quality of Acid Fast Bacilli (AFB) staining reagents was sub-standard. The overall agreement for blind rechecking of 1,123 AFB slides was 99.4% (Kappa = 0.97). Reading of 370 AFB panel slides showed 3.5% false reading (Kappa = 0.92). Moreover, the consistency of reading scanty bacilli slides was lower (93%) compared to 1+, 2+ and 3+ bacilli. Based on blind rechecking and panel testing results, PPM-DOTS site laboratories showed good agreement with the reference laboratory. Physical space and qualities of AFB reagents would be areas of intervention to sustain the quality of sputum smear microscopy. Therefore, regular external quality assessment and provision of basic laboratory supplies for TB diagnosis would be the way forward to improve the quality of sputum smear microscopy services in PPM-DOTS laboratories.

The Quality of Sputum Smear Microscopy in Public-Private Mix Directly Observed Treatment Laboratories in West Amhara Region, Ethiopia

PubMed Central

Manalebh, Almaw; Demissie, Meaza; Mekonnen, Daniel; Abera, Bayeh

2015-01-01

Ethiopia adopted Public-Private Mix Directly Observed Treatment Short Course Chemotherapy (PPM-DOTS) strategy for tuberculosis (TB) control program. Quality of sputum smear microscopy has paramount importance for tuberculosis control program in resource-poor countries like Ethiopia. A cross-sectional study was conducted to assess the quality of sputum smear microscopy in 37 Public-Private Mix laboratories in West Amhara, Ethiopia. The three external quality assessment methods (onsite evaluation, panel testing and blind rechecking) were employed. Onsite assessment revealed that 67.6% of PPM-DOTS laboratories were below the standard physical space (5 X 6) m2. The average monthly workload per laboratory technician was 19.5 (SD±2.9) slides with 12.8% positivity rate. The quality of Acid Fast Bacilli (AFB) staining reagents was sub-standard. The overall agreement for blind rechecking of 1,123 AFB slides was 99.4% (Kappa = 0.97). Reading of 370 AFB panel slides showed 3.5% false reading (Kappa = 0.92). Moreover, the consistency of reading scanty bacilli slides was lower (93%) compared to 1+, 2+ and 3+ bacilli. Based on blind rechecking and panel testing results, PPM-DOTS site laboratories showed good agreement with the reference laboratory. Physical space and qualities of AFB reagents would be areas of intervention to sustain the quality of sputum smear microscopy. Therefore, regular external quality assessment and provision of basic laboratory supplies for TB diagnosis would be the way forward to improve the quality of sputum smear microscopy services in PPM-DOTS laboratories. PMID:25849516

British Thoracic Society quality standards for home oxygen use in adults

PubMed Central

Suntharalingam, Jay; Wilkinson, Tom; Annandale, Joseph; Davey, Claire; Fielding, Rhea; Freeman, Daryl; Gibbons, Michael; Hardinge, Maxine; Hippolyte, Sabrine; Knowles, Vikki; Lee, Cassandra; MacNee, William; Pollington, Jacqueline; Vora, Vandana; Watts, Trefor; Wijesinghe, Meme

2017-01-01

Introduction The purpose of the quality standards document is to provide healthcare professionals, commissioners, service providers and patients with a guide to standards of care that should be met for home oxygen provision in the UK, together with measurable markers of good practice. Quality statements are based on the British Thoracic Society (BTS) Guideline for Home Oxygen Use in Adults. Methods Development of BTS Quality Standards follows the BTS process of quality standard production based on the National Institute for Health and Care Excellence process manual for the development of quality standards. Results 10 quality statements have been developed, each describing a key marker of high-quality, cost-effective care for home oxygen use, and each statement is supported by quality measures that aim to improve the structure, process and outcomes of healthcare. Discussion BTS Quality Standards for home oxygen use in adults form a key part of the range of supporting materials that the society produces to assist in the dissemination and implementation of a guideline’s recommendations. PMID:29018527

Implementation of basic quality control tests for malaria medicines in Amazon Basin countries: results for the 2005-2010 period.

PubMed

Pribluda, Victor S; Barojas, Adrian; Añez, Arletta; López, Cecilia G; Figueroa, Ruth; Herrera, Roxana; Nakao, Gladys; Nogueira, Fernando Ha; Pianetti, Gerson A; Povoa, Marinete M; Viana, Giselle Mr; Gomes, Margarete S Mendonça; Escobar, Jose P; Sierra, Olga L Muñoz; Norena, Susana P Rendon; Veloz, Raúl; Bravo, Marcy Silva; Aldás, Martha R; Hindssemple, Alison; Collins, Marilyn; Ceron, Nicolas; Krishnalall, Karanchand; Adhin, Malti; Bretas, Gustavo; Hernandez, Nelly; Mendoza, Marjorie; Smine, Abdelkrim; Chibwe, Kennedy; Lukulay, Patrick; Evans, Lawrence

2012-06-15

Ensuring the quality of malaria medicines is crucial in working toward malaria control and eventual elimination. Unlike other validated tests that can assess all critical quality attributes, which is the standard for determining the quality of medicines, basic tests are significantly less expensive, faster, and require less skilled labour; yet, these tests provide reproducible data and information on several critical quality attributes, such as identity, purity, content, and disintegration. Visual and physical inspection also provides valuable information about the manufacturing and the labelling of medicines, and in many cases this inspection is sufficient to detect counterfeit medicines. The Promoting the Quality of Medicines (PQM) programme has provided technical assistance to Amazon Malaria Initiative (AMI) countries to implement the use of basic tests as a key screening mechanism to assess the quality of malaria medicines available to patients in decentralized regions. Trained personnel from the National Malaria Control Programmes (NMCPs), often in collaboration with country's Official Medicine Control Laboratory (OMCL), developed country- specific protocols that encompassed sampling methods, sample analysis, and data reporting. Sampling sites were selected based on malaria burden, accessibility, and geographical location. Convenience sampling was performed and countries were recommended to store the sampled medicines under conditions that did not compromise their quality. Basic analytical tests, such as disintegration and thin layer chromatography (TLC), were performed utilizing a portable mini-laboratory. Results were originally presented at regional meetings in a non-standardized format that lacked relevant medicines information. However, since 2008 information has been submitted utilizing a template specifically developed by PQM for that purpose. From 2005 to 2010, the quality of 1,663 malaria medicines from seven AMI countries was evaluated, mostly collected from the public sector, 1,445/1,663 (86.9%). Results indicate that 193/1,663 (11.6%) were found not to meet quality specifications. Most failures were reported during visual and physical inspection, 142/1663 (8.5%), and most of these were due to expired medicines, 118/142 (83.1%). Samples failing TLC accounted for 27/1,663 (1.6%) and those failing disintegration accounted for 24/1,663 (1.4%). Medicines quality failures decreased significantly during the last two years. Basic tests revealed that the quality of medicines in the public sector improved over the years, since the implementation of this type of quality monitoring programme in 2005. However, the lack of consistent confirmatory tests in the quality control (QC) laboratory, utilizing methods that can also evaluate additional quality attributes, could still mask quality issues. In the future, AMI countries should improve coordination with their health authorities and their QC lab consistently, to provide a more complete picture of malaria medicines quality and support the implementation of corrective actions. Facilities in the private and informal sectors also should be included when these sectors constitute an important source of medicines used by malaria patients.

The potential for error in sampling

Treesearch

Jack Lewis

2000-01-01

Editor's note: The measurement of water quality parameters in environmental laboratories follows standard quality control protocols using methodologies approved by the U.S. Environmental Protection Agency. However, little attention has been given to quality assurance and quality control in activities outside the laboratory. This article describes some of those...

Safe household water treatment and storage using ceramic drip filters: a randomised controlled trial in Bolivia.

PubMed

Clasen, T; Brown, J; Suntura, O; Collin, S

2004-01-01

A randomised controlled field trial was conducted to evaluate the effectiveness of ceramic drip filters to improve the microbiological quality of drinking water in a low-income community in rural Bolivia. In four rounds of water sampling over five months, 100% of the samples were free of thermotolerant (faecal) coliforms (TTC) compared to an arithmetic mean TTC count of 1517, 406, 167 and 245 among control households which continued to use their customary sources of drinking water. The filter systems produced water that consistently met WHO drinking-water standards despite levels of turbidity that presented a challenge to other low-cost POU treatment methods. The filter systems also demonstrated an ability to maintain the high quality of the treated water against subsequent re-contamination in the home.

How to Sustain Change and Support Continuous Quality Improvement

PubMed Central

McQuillan, Rory; Harel, Ziv; Weizman, Adam V.; Thomas, Alison; Nesrallah, Gihad; Bell, Chaim M.; Chan, Christopher T.; Chertow, Glenn M.

2016-01-01

To achieve sustainable change, quality improvement initiatives must become the new way of working rather than something added on to routine clinical care. However, most organizational change is not maintained. In this next article in this Moving Points in Nephrology feature on quality improvement, we provide health care professionals with strategies to sustain and support quality improvement. Threats to sustainability may be identified both at the beginning of a project and when it is ready for implementation. The National Health Service Sustainability Model is reviewed as one example to help identify issues that affect long-term success of quality improvement projects. Tools to help sustain improvement include process control boards, performance boards, standard work, and improvement huddles. Process control and performance boards are methods to communicate improvement results to staff and leadership. Standard work is a written or visual outline of current best practices for a task and provides a framework to ensure that changes that have improved patient care are consistently and reliably applied to every patient encounter. Improvement huddles are short, regular meetings among staff to anticipate problems, review performance, and support a culture of improvement. Many of these tools rely on principles of visual management, which are systems transparent and simple so that every staff member can rapidly distinguish normal from abnormal working conditions. Even when quality improvement methods are properly applied, the success of a project still depends on contextual factors. Context refers to aspects of the local setting in which the project operates. Context affects resources, leadership support, data infrastructure, team motivation, and team performance. For these reasons, the same project may thrive in a supportive context and fail in a different context. To demonstrate the practical applications of these quality improvement principles, these principles are applied to a hypothetical quality improvement initiative that aims to promote home dialysis (home hemodialysis and peritoneal dialysis). PMID:27016498

Establishment of a Quality Management System Based on ISO 9001 Standard in a Public Service Fungal Culture Collection.

PubMed

Simões, Marta F; Dias, Nicolina; Santos, Cledir; Lima, Nelson

2016-06-22

Collaborations between different Microbiological Resource Centres (mBRCs) and ethical sourcing practices are mandatory to guarantee biodiversity conservation, successful and sustainable preservation and fair share of benefits that arise from the use of genetic resources. Since microbial Culture Collections (CCs) are now engaged in meeting high quality operational standards, they are facing the challenge of establishing quality control criteria to certify their biological materials. The authentication/certification of strains is nowadays a demand from the bioeconomy sector for the global operation of mBRCs. The achievement of consistent quality assurance and trust within the mBRCs and microbial CCs context is a dynamic and never-ending process. A good option to facilitate that process is to implement a Quality Management System (QMS) based on the ISO 9001 standard. Here, we report a detailed description of all the steps taken for the QMS implementation at the Portuguese CC of filamentous fungi: Micoteca da Universidade do Minho (MUM). Our aim is to provide guidelines for the certification of other CCs, so that they can also enhance the search and choice of the most consistent, reliable, and effective operating methods, with assured procedures and validation of preservation; and guarantee trustworthy relations with all stakeholders.

Establishment of a Quality Management System Based on ISO 9001 Standard in a Public Service Fungal Culture Collection

PubMed Central

Simões, Marta F.; Dias, Nicolina; Santos, Cledir; Lima, Nelson

2016-01-01

Collaborations between different Microbiological Resource Centres (mBRCs) and ethical sourcing practices are mandatory to guarantee biodiversity conservation, successful and sustainable preservation and fair share of benefits that arise from the use of genetic resources. Since microbial Culture Collections (CCs) are now engaged in meeting high quality operational standards, they are facing the challenge of establishing quality control criteria to certify their biological materials. The authentication/certification of strains is nowadays a demand from the bioeconomy sector for the global operation of mBRCs. The achievement of consistent quality assurance and trust within the mBRCs and microbial CCs context is a dynamic and never-ending process. A good option to facilitate that process is to implement a Quality Management System (QMS) based on the ISO 9001 standard. Here, we report a detailed description of all the steps taken for the QMS implementation at the Portuguese CC of filamentous fungi: Micoteca da Universidade do Minho (MUM). Our aim is to provide guidelines for the certification of other CCs, so that they can also enhance the search and choice of the most consistent, reliable, and effective operating methods, with assured procedures and validation of preservation; and guarantee trustworthy relations with all stakeholders. PMID:27681915

Electron-beam lithography with character projection technique for high-throughput exposure with line-edge quality control

NASA Astrophysics Data System (ADS)

Ikeno, Rimon; Maruyama, Satoshi; Mita, Yoshio; Ikeda, Makoto; Asada, Kunihiro

2016-07-01

The high throughput of character projection (CP) electron-beam (EB) lithography makes it a promising technique for low-to-medium volume device fabrication with regularly arranged layouts, such as for standard-cell logics and memory arrays. However, non-VLSI applications such as MEMS and MOEMS may not be able to fully utilize the benefits of the CP method due to the wide variety of layout figures including curved and oblique edges. In addition, the stepwise shapes that appear because of the EB exposure process often result in intolerable edge roughness, which degrades device performances. In this study, we propose a general EB lithography methodology for such applications utilizing a combination of the CP and variable-shaped beam methods. In the process of layout data conversion with CP character instantiation, several control parameters were optimized to minimize the shot count, improve the edge quality, and enhance the overall device performance. We have demonstrated EB shot reduction and edge-quality improvement with our methodology by using a leading-edge EB exposure tool, ADVANTEST F7000S-VD02, and a high-resolution hydrogen silsesquioxane resist. Atomic force microscope observations were used to analyze the resist edge profiles' quality to determine the influence of the control parameters used in the data conversion process.

Automatic first-arrival picking based on extended super-virtual interferometry with quality control procedure

NASA Astrophysics Data System (ADS)

An, Shengpei; Hu, Tianyue; Liu, Yimou; Peng, Gengxin; Liang, Xianghao

2017-12-01

Static correction is a crucial step of seismic data processing for onshore play, which frequently has a complex near-surface condition. The effectiveness of the static correction depends on an accurate determination of first-arrival traveltimes. However, it is difficult to accurately auto-pick the first arrivals for data with low signal-to-noise ratios (SNR), especially for those measured in the area of the complex near-surface. The technique of the super-virtual interferometry (SVI) has the potential to enhance the SNR of first arrivals. In this paper, we develop the extended SVI with (1) the application of the reverse correlation to improve the capability of SNR enhancement at near-offset, and (2) the usage of the multi-domain method to partially overcome the limitation of current method, given insufficient available source-receiver combinations. Compared to the standard SVI, the SNR enhancement of the extended SVI can be up to 40%. In addition, we propose a quality control procedure, which is based on the statistical characteristics of multichannel recordings of first arrivals. It can auto-correct the mispicks, which might be spurious events generated by the SVI. This procedure is very robust, highly automatic and it can accommodate large data in batches. Finally, we develop one automatic first-arrival picking method to combine the extended SVI and the quality control procedure. Both the synthetic and the field data examples demonstrate that the proposed method is able to accurately auto-pick first arrivals in seismic traces with low SNR. The quality of the stacked seismic sections obtained from this method is much better than those obtained from an auto-picking method, which is commonly employed by the commercial software.

Quality assurance and management in microelectronics companies: ISO 9000 versus Six Sigma

NASA Astrophysics Data System (ADS)

Lupan, Razvan; Kobi, Abdessamad; Robledo, Christian; Bacivarov, Ioan; Bacivarov, Angelica

2009-01-01

A strategy for the implementation of the Six Sigma method as an improvement solution for the ISO 9000:2000 Quality Standard is proposed. Our approach is focused on integrating the DMAIC cycle of the Six Sigma method with the PDCA process approach, highly recommended by the standard ISO 9000:2000. The Six Sigma steps applied to each part of the PDCA cycle are presented in detail, giving some tools and training examples. Based on this analysis the authors conclude that applying Six Sigma philosophy to the Quality Standard implementation process is the best way to achieve the optimal results in quality progress and therefore in customers satisfaction.

40 CFR 52.275 - Particulate matter control.

Code of Federal Regulations, 2010 CFR

2010-07-01

... National Ambient Air Quality Standards or any other applicable requirement of the Clean Air Act. (1) South Coast Air Quality Management District. (i) Rule 401, submitted on January 12, 1999. [43 FR 25675, June... interfere with the attainment and maintenance of the National Ambient Air Quality Standards. (1) Amador...

Validation and long-term evaluation of a modified on-line chiral analytical method for therapeutic drug monitoring of (R,S)-methadone in clinical samples.

PubMed

Ansermot, Nicolas; Rudaz, Serge; Brawand-Amey, Marlyse; Fleury-Souverain, Sandrine; Veuthey, Jean-Luc; Eap, Chin B

2009-08-01

Matrix effects, which represent an important issue in liquid chromatography coupled to mass spectrometry or tandem mass spectrometry detection, should be closely assessed during method development. In the case of quantitative analysis, the use of stable isotope-labelled internal standard with physico-chemical properties and ionization behaviour similar to the analyte is recommended. In this paper, an example of the choice of a co-eluting deuterated internal standard to compensate for short-term and long-term matrix effect in the case of chiral (R,S)-methadone plasma quantification is reported. The method was fully validated over a concentration range of 5-800 ng/mL for each methadone enantiomer with satisfactory relative bias (-1.0 to 1.0%), repeatability (0.9-4.9%) and intermediate precision (1.4-12.0%). From the results obtained during validation, a control chart process during 52 series of routine analysis was established using both intermediate precision standard deviation and FDA acceptance criteria. The results of routine quality control samples were generally included in the +/-15% variability around the target value and mainly in the two standard deviation interval illustrating the long-term stability of the method. The intermediate precision variability estimated in method validation was found to be coherent with the routine use of the method. During this period, 257 trough concentration and 54 peak concentration plasma samples of patients undergoing (R,S)-methadone treatment were successfully analysed for routine therapeutic drug monitoring.

Soyuz 7 Return Samples: Assessment of Air Quality Aboard the International Space Station

NASA Technical Reports Server (NTRS)

James, John T.

2004-01-01

The toxicological assessments of one grab sample canister (GSC), 6 dual sorbent tubes (DSTs), and 20 formaldehyde badges returned aboard Soyuz 7 are reported. Analytical methods have not changed from earlier reports. Surrogate standard recoveries from the GSC were 84-89%. The recoveries of the less volatile surrogates from the DSTs were 87 to 112%; however, 13C-acetone was only recovered at 53-59%. Formaldehyde recoveries from 2 lab controls were 87 and 95%; trip controls were not returned to ground.

Microbial ecology laboratory procedures manual NASA/MSFC

NASA Technical Reports Server (NTRS)

Huff, Timothy L.

1990-01-01

An essential part of the efficient operation of any microbiology laboratory involved in sample analysis is a standard procedures manual. The purpose of this manual is to provide concise and well defined instructions on routine technical procedures involving sample analysis and methods for monitoring and maintaining quality control within the laboratory. Of equal importance is the safe operation of the laboratory. This manual outlines detailed procedures to be followed in the microbial ecology laboratory to assure safety, analytical control, and validity of results.

Methods for the guideline-based development of quality indicators--a systematic review

PubMed Central

2012-01-01

Background Quality indicators (QIs) are used in many healthcare settings to measure, compare, and improve quality of care. For the efficient development of high-quality QIs, rigorous, approved, and evidence-based development methods are needed. Clinical practice guidelines are a suitable source to derive QIs from, but no gold standard for guideline-based QI development exists. This review aims to identify, describe, and compare methodological approaches to guideline-based QI development. Methods We systematically searched medical literature databases (Medline, EMBASE, and CINAHL) and grey literature. Two researchers selected publications reporting methodological approaches to guideline-based QI development. In order to describe and compare methodological approaches used in these publications, we extracted detailed information on common steps of guideline-based QI development (topic selection, guideline selection, extraction of recommendations, QI selection, practice test, and implementation) to predesigned extraction tables. Results From 8,697 hits in the database search and several grey literature documents, we selected 48 relevant references. The studies were of heterogeneous type and quality. We found no randomized controlled trial or other studies comparing the ability of different methodological approaches to guideline-based development to generate high-quality QIs. The relevant publications featured a wide variety of methodological approaches to guideline-based QI development, especially regarding guideline selection and extraction of recommendations. Only a few studies reported patient involvement. Conclusions Further research is needed to determine which elements of the methodological approaches identified, described, and compared in this review are best suited to constitute a gold standard for guideline-based QI development. For this research, we provide a comprehensive groundwork. PMID:22436067

75 FR 32178 - Release of Final Document Related to the Review of the National Ambient Air Quality Standards for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-07

... ``cause or contribute to air pollution which may reasonably be anticipated to endanger public health or... National Ambient Air Quality Standards: Scope and Methods Plan for Health Risk and Exposure Assessment... Related to the Review of the National Ambient Air Quality Standards for Carbon Monoxide AGENCY...

Assessment of the iodine concentration in table salt at the production stage in South Africa.

PubMed Central

Jooste, Pieter L.

2003-01-01

OBJECTIVE: To determine the iodine content of iodized salt at the production stage, to assess the perceptions and knowledge of salt producers about the prevention and control of iodine deficiency, and to examine the internal quality control procedures used during iodization in South Africa. METHOD: Salt samples were collected for iodine analysis by titration from the 12 producers iodizing salt in South Africa. Information on the producers' knowledge of iodine deficiency disorders and on internal quality control was obtained by means of questionnaires. FINDINGS: The legal requirement of 40-60 ppm iodine was met in 30.9% of salt samples; 57.9% contained more than 30 ppm iodine; 34.8% contained under 20 ppm iodine. There were shortcomings in perceptions and knowledge about iodine deficiency disorders and in the internal quality control procedures of a substantial proportion of the producers. CONCLUSION: In order to encourage and support salt producers to achieve optimal iodization there should be an information, education and communication strategy aimed at improving knowledge of iodine deficiency disorders and at raising the standard of internal quality control procedures. External monitoring should continue. PMID:12973644

Cardiac rehabilitation using the Family-Centered Empowerment Model versus home-based cardiac rehabilitation in patients with myocardial infarction: a randomised controlled trial

PubMed Central

Vahedian-Azimi, Amir; Hajiesmaieli, Mohammadreza; Kangasniemi, Mari; Alhani, Fatemah; Jelvehmoghaddam, Hosseinali; Fathi, Mohammad; Farzanegan, Behrooz; Ardehali, Seyed H; Hatamian, Sevak; Gahremani, Mehdi; Mosavinasab, Seyed M M; Rostami, Zohreh; Madani, Seyed J; Izadi, Morteza

2016-01-01

Objective To determine if a hybrid cardiac rehabilitation (CR) programme using the Family-Centered Empowerment Model (FCEM) as compared with standard CR will improve patient quality of life, perceived stress and state anxiety of patients with myocardial infarction (MI). Methods We conducted a randomised controlled trial in which patients received either standard home CR or CR using the FCEM strategy. Patient empowerment was measured with FCEM questionnaires preintervention and postintervention for a total of 9 assessments. Quality of life, perceived stress, and state and trait anxiety were assessed using the 36-Item Short Form Health Survey (SF-36), the 14-item Perceived Stress, and the 20-item State and 20-item Trait Anxiety questionnaires, respectively. Results 70 patients were randomised. Baseline characteristics were similar. Ejection fraction was significantly higher in the intervention group at measurements 2 (p=0.01) and 3 (p=0.001). Exercise tolerance measured as walking distance was significantly improved in the intervention group throughout the study. The quality of life results in the FCEM group showed significant improvement both within the group over time (p<0.0001) and when compared with control (p<0.0001). Similarly, the perceived stress and state anxiety results showed significant improvement both within the FCEM group over time (p<0.0001) and when compared with control (p<0.0001). No significant difference was found either within or between groups for trait anxiety. Conclusions The family-centred empowerment model may be an effective hybrid cardiac rehabilitation method for improving the physical and mental health of patients post-MI; however, further study is needed to validate these findings. Clinical Trials.gov identifier NCT02402582. Trial registration number NCT02402582. PMID:27110376

[Quality assessment in anesthesia].

PubMed

Kupperwasser, B

1996-01-01

Quality assessment (assurance/improvement) is the set of methods used to measure and improve the delivered care and the department's performance against pre-established criteria or standards. The four stages of the self-maintained quality assessment cycle are: problem identification, problem analysis, problem correction and evaluation of corrective actions. Quality assessment is a measurable entity for which it is necessary to define and calibrate measurement parameters (indicators) from available data gathered from the hospital anaesthesia environment. Problem identification comes from the accumulation of indicators. There are four types of quality indicators: structure, process, outcome and sentinel indicators. The latter signal a quality defect, are independent of outcomes, are easier to analyse by statistical methods and closely related to processes and main targets of quality improvement. The three types of methods to analyse the problems (indicators) are: peer review, quantitative methods and risks management techniques. Peer review is performed by qualified anaesthesiologists. To improve its validity, the review process should be explicited and conclusions based on standards of practice and literature references. The quantitative methods are statistical analyses applied to the collected data and presented in a graphic format (histogram, Pareto diagram, control charts). The risks management techniques include: a) critical incident analysis establishing an objective relationship between a 'critical' event and the associated human behaviours; b) system accident analysis, based on the fact that accidents continue to occur despite safety systems and sophisticated technologies, checks of all the process components leading to the impredictable outcome and not just the human factors; c) cause-effect diagrams facilitate the problem analysis in reducing its causes to four fundamental components (persons, regulations, equipment, process). Definition and implementation of corrective measures, based on the findings of the two previous stages, are the third step of the evaluation cycle. The Hawthorne effect is an outcome improvement, before the implementation of any corrective actions. Verification of the implemented actions is the final and mandatory step closing the evaluation cycle.

Piloting Vertical Flight Aircraft: A Conference on Flying Qualities and Human Factors

NASA Technical Reports Server (NTRS)

Blanken, Christopher L. (Editor); Whalley, Matthew S. (Editor)

1993-01-01

This document contains papers from a specialists' meeting entitled 'Piloting Vertical Flight Aircraft: A Conference on Flying Qualities and Human Factors.' Vertical flight aircraft, including helicopters and a variety of Vertical Takeoff and Landing (VTOL) concepts, place unique requirements on human perception, control, and performance for the conduct of their design missions. The intent of this conference was to examine, for these vehicles, advances in: (1) design of flight control systems for ADS-33C standards; (2) assessment of human factors influences of cockpit displays and operational procedures; (3) development of VTOL design and operational criteria; and (4) development of theoretical methods or models for predicting pilot/vehicle performance and mission suitability. A secondary goal of the conference was to provide an initial venue for enhanced interaction between human factors and handling qualities specialists.

78 FR 75902 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Philadelphia County...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-13

...] Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Philadelphia County Reasonably Available Control Technology Under the 1997 8-Hour Ozone National Ambient Air Quality Standard AGENCY... Department of Environmental Protection, Bureau of Air Quality Control, P.O. Box 8468, 400 Market Street...

Preanalytical errors in medical laboratories: a review of the available methodologies of data collection and analysis.

PubMed

West, Jamie; Atherton, Jennifer; Costelloe, Seán J; Pourmahram, Ghazaleh; Stretton, Adam; Cornes, Michael

2017-01-01

Preanalytical errors have previously been shown to contribute a significant proportion of errors in laboratory processes and contribute to a number of patient safety risks. Accreditation against ISO 15189:2012 requires that laboratory Quality Management Systems consider the impact of preanalytical processes in areas such as the identification and control of non-conformances, continual improvement, internal audit and quality indicators. Previous studies have shown that there is a wide variation in the definition, repertoire and collection methods for preanalytical quality indicators. The International Federation of Clinical Chemistry Working Group on Laboratory Errors and Patient Safety has defined a number of quality indicators for the preanalytical stage, and the adoption of harmonized definitions will support interlaboratory comparisons and continual improvement. There are a variety of data collection methods, including audit, manual recording processes, incident reporting mechanisms and laboratory information systems. Quality management processes such as benchmarking, statistical process control, Pareto analysis and failure mode and effect analysis can be used to review data and should be incorporated into clinical governance mechanisms. In this paper, The Association for Clinical Biochemistry and Laboratory Medicine PreAnalytical Specialist Interest Group review the various data collection methods available. Our recommendation is the use of the laboratory information management systems as a recording mechanism for preanalytical errors as this provides the easiest and most standardized mechanism of data capture.

Multiscale analysis of replication technique efficiency for 3D roughness characterization of manufactured surfaces

NASA Astrophysics Data System (ADS)

Jolivet, S.; Mezghani, S.; El Mansori, M.

2016-09-01

The replication of topography has been generally restricted to optimizing material processing technologies in terms of statistical and single-scale features such as roughness. By contrast, manufactured surface topography is highly complex, irregular, and multiscale. In this work, we have demonstrated the use of multiscale analysis on replicates of surface finish to assess the precise control of the finished replica. Five commercial resins used for surface replication were compared. The topography of five standard surfaces representative of common finishing processes were acquired both directly and by a replication technique. Then, they were characterized using the ISO 25178 standard and multiscale decomposition based on a continuous wavelet transform, to compare the roughness transfer quality at different scales. Additionally, atomic force microscope force modulation mode was used in order to compare the resins’ stiffness properties. The results showed that less stiff resins are able to replicate the surface finish along a larger wavelength band. The method was then tested for non-destructive quality control of automotive gear tooth surfaces.

British Thoracic Society quality standards for the investigation and management of pulmonary nodules

PubMed Central

Baldwin, David; Callister, Matthew; Akram, Ahsan; Cane, Paul; Draffan, Jeanette; Franks, Kevin; Gleeson, Fergus; Graham, Richard; Malhotra, Puneet; Pearson, Philip; Subesinghe, Manil; Waller, David; Woolhouse, Ian

2018-01-01

Introduction The purpose of the quality standards document is to provide healthcare professionals, commissioners, service providers and patients with a guide to standards of care that should be met for the investigation and management of pulmonary nodules in the UK, together with measurable markers of good practice. Methods Development of British Thoracic Society (BTS) Quality Standards follows the BTS process of quality standard production based on the National Institute for Health and Care Excellence process manual for the development of quality standards. Results 7 quality statements have been developed, each describing a key marker of high-quality, cost-effective care for the investigation and management of pulmonary nodules, and each statement is supported by quality measures that aim to improve the structure, process and outcomes of healthcare. Discussion BTS Quality Standards for the investigation and management of pulmonary nodules form a key part of the range of supporting materials that the Society produces to assist in the dissemination and implementation of guideline recommendations. PMID:29682290

Simultaneous determination of nine saponins from Panax notoginseng using HPLC and pressurized liquid extraction.

PubMed

Wan, J B; Lai, C M; Li, S P; Lee, M Y; Kong, L Y; Wang, Y T

2006-04-11

A HPLC and pressurized liquid extraction (PLE) method was developed for simultaneous determination of nine saponins, including notoginsenoside R1, ginsenoside Rg1, Re, Rf, Rb1, Rc, Rb2, Rb3 and Rd in Panax notoginseng. The analysis was performed on C18 column with water-acetonitrile gradient elution and the investigated saponins were authenticated by comparing retention time and mass spectra with their reference compounds. Several methods including PLE, ultrasonication, soxhlet extraction and immersion were used for sample preparation and their extraction efficiency was compared. The results showed that PLE has the highest extraction efficiency and repeatability, which would be valuable on standardization of sample preparation for quality control of Chinese medicines. The developed HPLC and PLE is an effective approach for simultaneously quantitative determination of sapoinins in P. notoginseng, which could be used for quality control of P. notoginseng and its preparations.

Amoeba-related health risk in drinking water systems: could monitoring of amoebae be a complementary approach to current quality control strategies?

PubMed

Codony, Francesc; Pérez, Leonardo Martín; Adrados, Bárbara; Agustí, Gemma; Fittipaldi, Mariana; Morató, Jordi

2012-01-01

Culture-based methods for fecal indicator microorganisms are the standard protocol to assess potential health risk from drinking water systems. However, these traditional fecal indicators are inappropriate surrogates for disinfection-resistant fecal pathogens and the indigenous pathogens that grow in drinking water systems. There is now a range of molecular-based methods, such as quantitative PCR, which allow detection of a variety of pathogens and alternative indicators. Hence, in addition to targeting total Escherichia coli (i.e., dead and alive) for the detection of fecal pollution, various amoebae may be suitable to indicate the potential presence of pathogenic amoeba-resisting microorganisms, such as Legionellae. Therefore, monitoring amoeba levels by quantitative PCR could be a useful tool for directly and indirectly evaluating health risk and could also be a complementary approach to current microbial quality control strategies for drinking water systems.

An assessment of scientific and technical aspects of closed investigations of canine forensics DNA – case series from the University of California, Davis, USA

PubMed Central

Scharnhorst, Günther; Kanthaswamy, Sree

2011-01-01

Aim To describe and assess the scientific and technical aspects of animal forensic testing at the University of California, Davis. The findings and recommendations contained in this report are designed to assess the past, evaluate the present, and recommend reforms that will assist the animal forensic science community in providing the best possible services that comply with court standards and bear judicial scrutiny. Methods A batch of 32 closed files of domestic dog DNA cases processed at the University of California, Davis, between August 2003 and July 2005 were reviewed in this study. The case files comprised copies of all original paperwork, copies of the cover letter or final report, laboratory notes, notes on analyses, submission forms, internal chains of custody, printed images and photocopies of evidence, as well as the administrative and technical reviews of those cases. Results While the fundamental aspects of animal DNA testing may be reliable and acceptable, the scientific basis for forensic testing animal DNA needs to be improved substantially. In addition to a lack of standardized and validated genetic testing protocols, improvements are needed in a wide range of topics including quality assurance and quality control measures, sample handling, evidence testing, statistical analysis, and reporting. Conclusion This review implies that although a standardized panel of short tandem repeat and mitochondrial DNA markers and publicly accessible genetic databases for canine forensic DNA analysis are already available, the persistent lack of supporting resources, including standardized quality assurance and quality control programs, still plagues the animal forensic community. This report focuses on closed cases from the period 2003-2005, but extends its scope more widely to include other animal DNA forensic testing services. PMID:21674824

Ultrasonication extraction and gel permeation chromatography clean-up for the determination of polycyclic aromatic hydrocarbons in edible oil by an isotope dilution gas chromatography–mass spectrometry.

PubMed

Wang, Jian-Hua; Guo, Cui

2010-07-09

An analytical method for the determination of US EPA priority pollutant 16 polycyclic aromatic hydrocarbons (PAHs) in edible oil was developed by an isotope dilution gas chromatography-mass spectrometry (GC-MS). Extraction was performed with ultrasonication mode using acetonitrile as solvent, and subsequent clean-up was applied using narrow gel permeation chromatographic column. Three deuterated PAHs surrogate standards were used as internal standards for quantification and analytical quality control. The limits of quantification (LOQs) were globally below 0.5 ng/g, the recoveries were in the range of 81-96%, and the relative standard deviations (RSDs) were lower than 20%. Further trueness assessment of the method was also verified through participation in international cocoa butter proficiency test (T0638) organised by the FAPAS with excellent results in 2008. The results obtained with the described method were satisfying (z ≤ 2). The method has been applied to determine PAH in real edible oil samples.

Software Quality Assurance and Controls Standard

DTIC Science & Technology

2010-04-27

Software Quality Assurance d C t l St d dan on ro s an ar Sue Carroll Principal Software Quality Analyst, SAS John Wal z VP Technology and...for Information Operations and Reports, 1215 Jefferson Davis Highway, Suite 1204, Arlington VA 22202-4302. Respondents should be aware that...Cycle (SLC) process? • What is in a SQA Process? • Where are SQA Controls? • What is the SQA standards history? Wh t i h i i SQA?• a s c ang ng n

Benchmarking Is Associated With Improved Quality of Care in Type 2 Diabetes

PubMed Central

Hermans, Michel P.; Elisaf, Moses; Michel, Georges; Muls, Erik; Nobels, Frank; Vandenberghe, Hans; Brotons, Carlos

2013-01-01

OBJECTIVE To assess prospectively the effect of benchmarking on quality of primary care for patients with type 2 diabetes by using three major modifiable cardiovascular risk factors as critical quality indicators. RESEARCH DESIGN AND METHODS Primary care physicians treating patients with type 2 diabetes in six European countries were randomized to give standard care (control group) or standard care with feedback benchmarked against other centers in each country (benchmarking group). In both groups, laboratory tests were performed every 4 months. The primary end point was the percentage of patients achieving preset targets of the critical quality indicators HbA1c, LDL cholesterol, and systolic blood pressure (SBP) after 12 months of follow-up. RESULTS Of 4,027 patients enrolled, 3,996 patients were evaluable and 3,487 completed 12 months of follow-up. Primary end point of HbA1c target was achieved in the benchmarking group by 58.9 vs. 62.1% in the control group (P = 0.398) after 12 months; 40.0 vs. 30.1% patients met the SBP target (P < 0.001); 54.3 vs. 49.7% met the LDL cholesterol target (P = 0.006). Percentages of patients meeting all three targets increased during the study in both groups, with a statistically significant increase observed in the benchmarking group. The percentage of patients achieving all three targets at month 12 was significantly larger in the benchmarking group than in the control group (12.5 vs. 8.1%; P < 0.001). CONCLUSIONS In this prospective, randomized, controlled study, benchmarking was shown to be an effective tool for increasing achievement of critical quality indicators and potentially reducing patient cardiovascular residual risk profile. PMID:23846810

MetNH3: Metrology for ammonia in ambient air

NASA Astrophysics Data System (ADS)

Braban, Christine; Twigg, Marsailidh; Tang, Sim; Leuenberger, Daiana; Ferracci, Valerio; Martin, Nick; Pascale, Celine; Hieta, Tuomas; Pogany, Andrea; Persijn, Stefan; van Wijk, Janneke; Gerwig, Holger; Wirtze, Klaus; Tiebe, Carlo; Balslev-Harder, David; Niederhausen, Bernhardt

2015-04-01

Measuring ammonia in ambient air is a sensitive and priority issue due to its harmful effects on human health and ecosystems. The European Directive 2001/81/EC on 'National Emission Ceilings for Certain Atmospheric Pollutants (NEC)' regulates ammonia emissions in the member states. However, there is a lack of regulation to ensure reliable ammonia measurements namely in applicable analytical technology, maximum allowed uncertainty, quality assurance and quality control (QC/QA) procedures as well as in the infrastructure to attain metrological traceability. Validated ammonia measurement data of high quality from air monitoring networks are vitally important for identifying changes due to implementations of environment policies, for understanding where the uncertainties in current emission inventories are derived from and for providing independent verification of atmospheric model predictions. The new EURAMET project MetNH3 aims to develop improved reference gas mixtures by static and dynamic gravimetric generation methods, develop and characterise laser based optical spectrometric standards and establish the transfer from high-accuracy standards to field applicable methods. MetNH3started in June 2014 and in this presentation the first results from the metrological characterisation of a commercially available cavity ring-down spectrometer (CRDS) will be discussed. Also first tests and results from a new design, Controlled Atmosphere Test Facility (CATFAC), which is to be characterised and used to validate the performance of diffusive samplers, denuders and on-line instruments, will be reported. CAFTEC can be used to control test parameters such as ammonia concentration, relative humidity and wind speed. Outline plans for international laboratory and field intercomparisons in 2016 will be presented.

Machine Learning Methods for Production Cases Analysis

NASA Astrophysics Data System (ADS)

Mokrova, Nataliya V.; Mokrov, Alexander M.; Safonova, Alexandra V.; Vishnyakov, Igor V.

2018-03-01

Approach to analysis of events occurring during the production process were proposed. Described machine learning system is able to solve classification tasks related to production control and hazard identification at an early stage. Descriptors of the internal production network data were used for training and testing of applied models. k-Nearest Neighbors and Random forest methods were used to illustrate and analyze proposed solution. The quality of the developed classifiers was estimated using standard statistical metrics, such as precision, recall and accuracy.

Informatics and Standards for Nanomedicine Technology

PubMed Central

Thomas, Dennis G.; Klaessig, Fred; Harper, Stacey L.; Fritts, Martin; Hoover, Mark D.; Gaheen, Sharon; Stokes, Todd H.; Reznik-Zellen, Rebecca; Freund, Elaine T.; Klemm, Juli D.; Paik, David S.; Baker, Nathan A.

2011-01-01

There are several issues to be addressed concerning the management and effective use of information (or data), generated from nanotechnology studies in biomedical research and medicine. These data are large in volume, diverse in content, and are beset with gaps and ambiguities in the description and characterization of nanomaterials. In this work, we have reviewed three areas of nanomedicine informatics: information resources; taxonomies, controlled vocabularies, and ontologies; and information standards. Informatics methods and standards in each of these areas are critical for enabling collaboration, data sharing, unambiguous representation and interpretation of data, semantic (meaningful) search and integration of data; and for ensuring data quality, reliability, and reproducibility. In particular, we have considered four types of information standards in this review, which are standard characterization protocols, common terminology standards, minimum information standards, and standard data communication (exchange) formats. Currently, due to gaps and ambiguities in the data, it is also difficult to apply computational methods and machine learning techniques to analyze, interpret and recognize patterns in data that are high dimensional in nature, and also to relate variations in nanomaterial properties to variations in their chemical composition, synthesis, characterization protocols, etc. Progress towards resolving the issues of information management in nanomedicine using informatics methods and standards discussed in this review will be essential to the rapidly growing field of nanomedicine informatics. PMID:21721140

The NINDS Parkinson's disease biomarkers program: The Ninds Parkinson's Disease Biomarkers Program

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

Rosenthal, Liana S.; Drake, Daniel; Alcalay, Roy N.

Background: Neuroprotection for Parkinson Disease (PD) remains elusive. Biomarkers hold the promise of removing roadblocks to therapy development. The National Institute of Neurological Disorders and Stroke (NINDS) has therefore established the Parkinson’s Disease Biomarkers Program (PDBP) to promote discovery of biomarkers for use in phase II-III clinical trials in PD. Methods: The PDBP facilitates biomarker development to improve neuroprotective clinical trial design, essential for advancing therapeutics for PD. To date, eleven consortium projects in the PDBP are focused on the development of clinical and laboratory-based PD biomarkers for diagnosis, progression tracking, and/or the prediction of prognosis. Seven of these projectsmore » also provide detailed longitudinal data and biospecimens from PD patients and controls, as a resource for all PD researchers. Standardized operating procedures and pooled reference samples have been created in order to allow cross-project comparisons and assessment of batch effects. A web-based Data Management Resource facilitates rapid sharing of data and biosamples across the entire PD research community for additional biomarker projects. Results: Here we describe the PDBP, highlight standard operating procedures for the collection of biospecimens and data, and provide an interim report with quality control analysis on the first 1082 participants and 1033 samples with quality control analysis collected as of October 2014. Conclusions: By making samples and data available to academics and industry, encouraging the adoption of existing standards, and providing a resource which complements existing programs, the PDBP will accelerate the pace of PD biomarker research, with the goal of improving diagnostic methods and treatment.« less

[Comparison and review on specifications of fermented Cordyceps sinensis products].

PubMed

Yang, Ping; Zhao, Xiao-Xia; Zhang, Yong-Wen

2018-02-01

There are five kinds of fermented Cordyceps crude drug and their preparations that have been approved as medicine on the market. Since the initial strains of the crude drug were all isolated from natural Cordyceps sinensis， they have similar names， chemical components and even clinical applications. However， because of the different strain species and fermentation processes， there was significant difference in quality. As a result， they should be clearly distinguished in clinical use. Most of the products were researched and developed during the 1980s and 1990s， so there was difference in quality standards for different products， and their quality control levels of some products were not perfect. At present， some of the products are approved as Chinese medicine， others are approved as chemical drugs， with a confusion in products name， management and clinical application. In this paper， the approval numbers， quality standards and clinical applications， and current problems of these products were summarized and compared; some suggestions were put forward， such as standardizing the product name， unifying the management of approval number category， and increasing the specific quality control attributes， in order to provide reference for standard implementation， quality control and drug regulation for fermented Cordyceps crude drugs and their preparations. Copyright© by the Chinese Pharmaceutical Association.

Armored DNA in recombinant Baculoviruses as controls in molecular genetic assays.

PubMed

Freystetter, Andrea; Paar, Christian; Stekel, Herbert; Berg, Jörg

2017-10-01

The widespread use of molecular PCR-based assays in analytical and clinical laboratories brings about the need for test-specific, stable, and reliable external controls (EC) as well as standards and internal amplification controls (IC), in order to arrive at consistent test results. In addition, there is also a growing need to produce and provide stable, well-characterized molecular controls for quality assurance programs. In this study, we describe a novel approach to generate armored double-stranded DNA controls, which are encapsulated in baculovirus (BV) particles of the species Autographa californica multiple nucleopolyhedrovirus. We used the well-known BacPAK™ Baculovirus Expression System (Takara-Clontech), removed the polyhedrin promoter used for protein expression, and generated recombinant BV-armored DNAs. The obtained BV-armored DNAs were readily extracted by standard clinical DNA extraction methods, showed favorable linearity and performance in our clinical PCR assays, were resistant to DNase I digestion, and exhibited marked stability in human plasma and serum. BV-armored DNA ought to be used as ECs, quantification standards, and ICs in molecular assays, with the latter application allowing for the entire monitoring of clinical molecular assays for sample adequacy. BV-armored DNA may also be used to produce double-stranded DNA reference materials for, e.g., quality assurance programs. The ease to produce BV-armored DNA should make this approach feasible for a broad spectrum of molecular applications. Finally, as BV-armored DNAs are non-infectious to mammals, they may be even more conveniently shipped than clinical specimen.

[Essential guidelines for Quality Management System].

PubMed

Daunizeau, A

2013-06-01

The guidelines describe the essential parts of the quality management system to fulfil the requirements of the standard EN ISO 15 189. It includes mainly the organisation, the definition of responsibilities, training of personnel, the document control, the quality control, identification and control of nonconformities, corrective actions, preventive actions and evaluation, as audits and the management review.

Comparison of Hypnotherapy and Standard Medical Treatment Alone on Quality of Life in Patients with Irritable Bowel Syndrome: A Randomized Controlled Trial

PubMed Central

Shahbazi, Korosh; Solati, Kamal

2016-01-01

Introduction Irritable bowel syndrome (IBS) is one of the most prevalent gastroenterological disorders. IBS is characterized by abdominal pain, cramping, diarrhea, constipation, bloating and flatulence. Complementary therapy is a group of diverse therapeutic and health care systems products that are used in treatment of IBS. Hypnotherapy helps to alleviate the symptoms of a broad range of diseases and conditions. It can be used independently or along with other treatments. Aim This study was conducted to compare therapeutic effect of hypnotherapy plus standard medical treatment and standard medical treatment alone on quality of life in patients with IBS. Materials and Methods This study is a clinical trial investigating 60 patients who were enrolled according to Rome-III criteria. The sample size was determined per statistical advice, previous studies, and the formula of sample size calculation. The participants were randomly assigned to two groups of hypnotherapy plus standard medical treatment group (n: 30), and standard medical treatment group (30). The study consisted of three steps; prior to treatment, after treatment and six months after the last intervention (follow-up). The instruments of data gathering were a questionnaire of demographic characteristics and standard questionnaire of quality of life for IBS patients (Quality of Life IBS-34). The data were analysed by analysis of co-variance, Levene’s test and descriptive statistics in SPSS-18. Results There were significant differences between the two groups of study in post-treatment and follow-up stage with regards to quality of life (p<0.05). Conclusion Psychological intervention, particularly hypno-therapy, alongside standard medical therapy could contribute to improving quality of life, pain and fatigue, and psychological disorder in IBS patients resistant to treatment. Also, therapeutic costs, hospital stay and days lost from work could be decreased and patients’ efficiency could be increased. PMID:27437261

40 CFR 160.35 - Quality assurance unit.

Code of Federal Regulations, 2012 CFR

2012-07-01

... standard operating procedures were made without proper authorization and documentation. (6) Review the final study report to assure that such report accurately describes the methods and standard operating... LABORATORY PRACTICE STANDARDS Organization and Personnel § 160.35 Quality assurance unit. (a) A testing...

40 CFR 160.35 - Quality assurance unit.

Code of Federal Regulations, 2010 CFR

2010-07-01

... standard operating procedures were made without proper authorization and documentation. (6) Review the final study report to assure that such report accurately describes the methods and standard operating... LABORATORY PRACTICE STANDARDS Organization and Personnel § 160.35 Quality assurance unit. (a) A testing...

40 CFR 160.35 - Quality assurance unit.

Code of Federal Regulations, 2014 CFR

2014-07-01

... standard operating procedures were made without proper authorization and documentation. (6) Review the final study report to assure that such report accurately describes the methods and standard operating... LABORATORY PRACTICE STANDARDS Organization and Personnel § 160.35 Quality assurance unit. (a) A testing...

40 CFR 160.35 - Quality assurance unit.

Code of Federal Regulations, 2013 CFR

2013-07-01

... standard operating procedures were made without proper authorization and documentation. (6) Review the final study report to assure that such report accurately describes the methods and standard operating... LABORATORY PRACTICE STANDARDS Organization and Personnel § 160.35 Quality assurance unit. (a) A testing...

40 CFR 160.35 - Quality assurance unit.

Code of Federal Regulations, 2011 CFR

2011-07-01

... standard operating procedures were made without proper authorization and documentation. (6) Review the final study report to assure that such report accurately describes the methods and standard operating... LABORATORY PRACTICE STANDARDS Organization and Personnel § 160.35 Quality assurance unit. (a) A testing...

Rational quality assessment procedure for less-investigated herbal medicines: Case of a Congolese antimalarial drug with an analytical report.

PubMed

Tshitenge, Dieudonné Tshitenge; Ioset, Karine Ndjoko; Lami, José Nzunzu; Ndelo-di-Phanzu, Josaphat; Mufusama, Jean-Pierre Koy Sita; Bringmann, Gerhard

2016-04-01

Herbal medicines are the most globally used type of medical drugs. Their high cultural acceptability is due to the experienced safety and efficiency over centuries of use. Many of them are still phytochemically less-investigated, and are used without standardization or quality control. Choosing SIROP KILMA, an authorized Congolese antimalarial phytomedicine, as a model case, our study describes an interdisciplinary approach for a rational quality assessment of herbal drugs in general. It combines an authentication step of the herbal remedy prior to any fingerprinting, the isolation of the major constituents, the development and validation of an HPLC-DAD analytical method with internal markers, and the application of the method to several batches of the herbal medicine (here KILMA) thus permitting the establishment of a quantitative fingerprint. From the constitutive plants of KILMA, acteoside, isoacteoside, stachannin A, and pectolinarigenin-7-O-glucoside were isolated, and acteoside was used as the prime marker for the validation of an analytical method. This study contributes to the efforts of the WHO for the establishment of standards enabling the analytical evaluation of herbal materials. Moreover, the paper describes the first phytochemical and analytical report on a marketed Congolese phytomedicine. Copyright © 2016 Elsevier B.V. All rights reserved.

Methods for assessing the quality of mammalian embryos: How far we are from the gold standard?

PubMed

Rocha, José C; Passalia, Felipe; Matos, Felipe D; Maserati, Marc P; Alves, Mayra F; Almeida, Tamie G de; Cardoso, Bruna L; Basso, Andrea C; Nogueira, Marcelo F G

2016-08-01

Morphological embryo classification is of great importance for many laboratory techniques, from basic research to the ones applied to assisted reproductive technology. However, the standard classification method for both human and cattle embryos, is based on quality parameters that reflect the overall morphological quality of the embryo in cattle, or the quality of the individual embryonic structures, more relevant in human embryo classification. This assessment method is biased by the subjectivity of the evaluator and even though several guidelines exist to standardize the classification, it is not a method capable of giving reliable and trustworthy results. Latest approaches for the improvement of quality assessment include the use of data from cellular metabolism, a new morphological grading system, development kinetics and cleavage symmetry, embryo cell biopsy followed by pre-implantation genetic diagnosis, zona pellucida birefringence, ion release by the embryo cells and so forth. Nowadays there exists a great need for evaluation methods that are practical and non-invasive while being accurate and objective. A method along these lines would be of great importance to embryo evaluation by embryologists, clinicians and other professionals who work with assisted reproductive technology. Several techniques shows promising results in this sense, one being the use of digital images of the embryo as basis for features extraction and classification by means of artificial intelligence techniques (as genetic algorithms and artificial neural networks). This process has the potential to become an accurate and objective standard for embryo quality assessment.

Methods for assessing the quality of mammalian embryos: How far we are from the gold standard?

PubMed Central

Rocha, José C.; Passalia, Felipe; Matos, Felipe D.; Maserati Jr, Marc P.; Alves, Mayra F.; de Almeida, Tamie G.; Cardoso, Bruna L.; Basso, Andrea C.; Nogueira, Marcelo F. G.

2016-01-01

Morphological embryo classification is of great importance for many laboratory techniques, from basic research to the ones applied to assisted reproductive technology. However, the standard classification method for both human and cattle embryos, is based on quality parameters that reflect the overall morphological quality of the embryo in cattle, or the quality of the individual embryonic structures, more relevant in human embryo classification. This assessment method is biased by the subjectivity of the evaluator and even though several guidelines exist to standardize the classification, it is not a method capable of giving reliable and trustworthy results. Latest approaches for the improvement of quality assessment include the use of data from cellular metabolism, a new morphological grading system, development kinetics and cleavage symmetry, embryo cell biopsy followed by pre-implantation genetic diagnosis, zona pellucida birefringence, ion release by the embryo cells and so forth. Nowadays there exists a great need for evaluation methods that are practical and non-invasive while being accurate and objective. A method along these lines would be of great importance to embryo evaluation by embryologists, clinicians and other professionals who work with assisted reproductive technology. Several techniques shows promising results in this sense, one being the use of digital images of the embryo as basis for features extraction and classification by means of artificial intelligence techniques (as genetic algorithms and artificial neural networks). This process has the potential to become an accurate and objective standard for embryo quality assessment. PMID:27584609

Determination of perfluorinated alkyl acid concentrations in biological standard reference materials.

PubMed

Reiner, Jessica L; O'Connell, Steven G; Butt, Craig M; Mabury, Scott A; Small, Jeff M; De Silva, Amila O; Muir, Derek C G; Delinsky, Amy D; Strynar, Mark J; Lindstrom, Andrew B; Reagen, William K; Malinsky, Michelle; Schäfer, Sandra; Kwadijk, Christiaan J A F; Schantz, Michele M; Keller, Jennifer M

2012-11-01

Standard reference materials (SRMs) are homogeneous, well-characterized materials used to validate measurements and improve the quality of analytical data. The National Institute of Standards and Technology (NIST) has a wide range of SRMs that have mass fraction values assigned for legacy pollutants. These SRMs can also serve as test materials for method development, method validation, and measurement for contaminants of emerging concern. Because inter-laboratory comparison studies have revealed substantial variability of measurements of perfluoroalkyl acids (PFAAs), future analytical measurements will benefit from determination of consensus values for PFAAs in SRMs to provide a means to demonstrate method-specific performance. To that end, NIST, in collaboration with other groups, has been measuring concentrations of PFAAs in a variety of SRMs. Here we report levels of PFAAs and perfluorooctane sulfonamide (PFOSA) determined in four biological SRMs: fish tissue (SRM 1946 Lake Superior Fish Tissue, SRM 1947 Lake Michigan Fish Tissue), bovine liver (SRM 1577c), and mussel tissue (SRM 2974a). We also report concentrations for three in-house quality-control materials: beluga whale liver, pygmy sperm whale liver, and white-sided dolphin liver. Measurements in SRMs show an array of PFAAs, with perfluorooctane sulfonate (PFOS) being the most frequently detected. Reference and information values are reported for PFAAs measured in these biological SRMs.

Simultaneous characterization and quantification of 17 main compounds in Rabdosia rubescens by high performance liquid chromatography.

PubMed

Guo, Sen; Cui, Xueqin; Jiang, Mi; Bai, Lu; Tian, Xiao; Guo, Tiantian; Liu, Qingchao; Zhang, Li; Ho, Chi-Tang; Bai, Naisheng

2017-04-01

Rabdosia rubescens is a healthy herbal tea and well-known Chinese medicinal herb. To evaluate the quality of R. rubescens from China, a high performance liquid chromatography method with dual-wavelength detection was developed and validated. The method was successfully applied for the simultaneous characterization and quantification of 17 main constituents from four different cultivation regions in China. Under optimal conditions, analysis was performed on a Luna C-18 column and gradient elution with a solvent system of acetonitrile and 0.5% (v/v) acetic acid-water at a flow rate of 1.0 mL/min and wavelength of 220 nm and 280 nm. All standard calibration curves exhibited good linearity (r 2  > 0.9992) within the test ranges. The precision was evaluated by intraday and interday tests, which revealed relative standard deviation values within the ranges of 0.57-2.35% and 0.52-3.40%, respectively. The recoveries were in the range of 96.37-101.66%. The relative standard deviation values for stability and repeatability were < 5%. The contents of some compounds were low and varied with different cultivars. The proposed method could serve as a prerequisite for quality control of R. rubescens materials and products. Copyright © 2016. Published by Elsevier B.V.

Validation of analytical methods in GMP: the disposable Fast Read 102® device, an alternative practical approach for cell counting.

PubMed

Gunetti, Monica; Castiglia, Sara; Rustichelli, Deborah; Mareschi, Katia; Sanavio, Fiorella; Muraro, Michela; Signorino, Elena; Castello, Laura; Ferrero, Ivana; Fagioli, Franca

2012-05-31

The quality and safety of advanced therapy products must be maintained throughout their production and quality control cycle to ensure their final use in patients. We validated the cell count method according to the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use and European Pharmacopoeia, considering the tests' accuracy, precision, repeatability, linearity and range. As the cell count is a potency test, we checked accuracy, precision, and linearity, according to ICH Q2. Briefly our experimental approach was first to evaluate the accuracy of Fast Read 102® compared to the Bürker chamber. Once the accuracy of the alternative method was demonstrated, we checked the precision and linearity test only using Fast Read 102®. The data were statistically analyzed by average, standard deviation and coefficient of variation percentages inter and intra operator. All the tests performed met the established acceptance criteria of a coefficient of variation of less than ten percent. For the cell count, the precision reached by each operator had a coefficient of variation of less than ten percent (total cells) and under five percent (viable cells). The best range of dilution, to obtain a slope line value very similar to 1, was between 1:8 and 1:128. Our data demonstrated that the Fast Read 102® count method is accurate, precise and ensures the linearity of the results obtained in a range of cell dilution. Under our standard method procedures, this assay may thus be considered a good quality control method for the cell count as a batch release quality control test. Moreover, the Fast Read 102® chamber is a plastic, disposable device that allows a number of samples to be counted in the same chamber. Last but not least, it overcomes the problem of chamber washing after use and so allows a cell count in a clean environment such as that in a Cell Factory. In a good manufacturing practice setting the disposable cell counting devices will allow a single use of the count chamber they can then be thrown away, thus avoiding the waste disposal of vital dye (e.g. Trypan Blue) or lysing solution (e.g. Tuerk solution).

Global chemical profiling based quality evaluation approach of rhubarb using ultra performance liquid chromatography with tandem quadrupole time-of-flight mass spectrometry.

PubMed

Zhang, Li; Liu, Haiyu; Qin, Lingling; Zhang, Zhixin; Wang, Qing; Zhang, Qingqing; Lu, Zhiwei; Wei, Shengli; Gao, Xiaoyan; Tu, Pengfei

2015-02-01

A global chemical profiling based quality evaluation approach using ultra performance liquid chromatography with tandem quadrupole time-of-flight mass spectrometry was developed for the quality evaluation of three rhubarb species, including Rheum palmatum L., Rheum tanguticum Maxim. ex Balf., and Rheum officinale Baill. Considering that comprehensive detection of chemical components is crucial for the global profile, a systemic column performance evaluation method was developed. Based on this, a Cortecs column was used to acquire the chemical profile, and Chempattern software was employed to conduct similarity evaluation and hierarchical cluster analysis. The results showed R. tanguticum could be differentiated from R. palmatum and R. officinale at the similarity value 0.65, but R. palmatum and R. officinale could not be distinguished effectively. Therefore, a common pattern based on three rhubarb species was developed to conduct the quality evaluation, and the similarity value 0.50 was set as an appropriate threshold to control the quality of rhubarb. A total of 88 common peaks were identified by their accurate mass and fragmentation, and partially verified by reference standards. Through the verification, the newly developed method could be successfully used for evaluating the holistic quality of rhubarb. It would provide a reference for the quality control of other herbal medicines. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

A method of setting limits for the purpose of quality assurance

NASA Astrophysics Data System (ADS)

Sanghangthum, Taweap; Suriyapee, Sivalee; Kim, Gwe-Ya; Pawlicki, Todd

2013-10-01

The result from any assurance measurement needs to be checked against some limits for acceptability. There are two types of limits; those that define clinical acceptability (action limits) and those that are meant to serve as a warning that the measurement is close to the action limits (tolerance limits). Currently, there is no standard procedure to set these limits. In this work, we propose an operational procedure to set tolerance limits and action limits. The approach to establish the limits is based on techniques of quality engineering using control charts and a process capability index. The method is different for tolerance limits and action limits with action limits being categorized into those that are specified and unspecified. The procedure is to first ensure process control using the I-MR control charts. Then, the tolerance limits are set equal to the control chart limits on the I chart. Action limits are determined using the Cpm process capability index with the requirements that the process must be in-control. The limits from the proposed procedure are compared to an existing or conventional method. Four examples are investigated: two of volumetric modulated arc therapy (VMAT) point dose quality assurance (QA) and two of routine linear accelerator output QA. The tolerance limits range from about 6% larger to 9% smaller than conventional action limits for VMAT QA cases. For the linac output QA, tolerance limits are about 60% smaller than conventional action limits. The operational procedure describe in this work is based on established quality management tools and will provide a systematic guide to set up tolerance and action limits for different equipment and processes.

Effects of foot massage applied in two different methods on symptom control in colorectal cancer patients: Randomised control trial.

PubMed

Uysal, Neşe; Kutlutürkan, Sevinç; Uğur, Işıl

2017-06-01

This randomized controlled clinical study aimed to determine the effect of 2 foot massage methods on symptom control in people with colorectal cancer who received chemoradiotherapy. Data were collected between June 16, 2015, and February 10, 2016, in the Department of Radiation Oncology of an oncology training and research hospital. The sample comprised 60 participants. Data were collected using an introductory information form, common terminology criteria for adverse events and European Organization for Research and Treatment of Cancer Quality of Life Questionnaires C30 and CR29. Participants were randomly allocated to 3 groups: classical foot massage, reflexology, and standard care control. The classical massage group received foot massage using classical massage techniques, and the reflexology group received foot reflexology focusing on symptom-oriented reflexes twice a week during a 5-week chemoradiotherapy treatment schedule. The control group received neither classical massage nor reflexology. All patients were provided with the same clinic routine care. The classical massage was effective in reducing pain level and distension incidence while foot reflexology was effective in reducing pain and fatigue level, lowering incidence of distension and urinary frequency and improving life quality. © 2017 John Wiley & Sons Australia, Ltd.

77 FR 39456 - Approval and Promulgation of Air Quality Implementation Plans; Delaware; Section 110(a)(2...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-03

... tribal law. List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, lead... the 2008 Lead National Ambient Air Quality Standards AGENCY: Environmental Protection Agency (EPA..., necessary to implement, maintain, and enforce the 2008 lead national ambient air quality standards (NAAQS...

7 CFR 989.702 - Minimum grade standards for packed raisins.

Code of Federal Regulations, 2010 CFR

2010-01-01

... RAISINS PRODUCED FROM GRAPES GROWN IN CALIFORNIA Quality Control § 989.702 Minimum grade standards for... washed with water to assure a wholesome product. (2) Grades. (i) Marketing Order Grade A is a quality of... paragraph. (ii) Marketing Order Grade B is the quality of the Cluster Seedless raisins that have similar...

Imaging biomarkers in liver fibrosis.

PubMed

Berzigotti, A; França, M; Martí-Aguado, D; Martí-Bonmatí, L

There is a need for early identification of patients with chronic liver diseases due to their increasing prevalence and morbidity-mortality. The degree of liver fibrosis determines the prognosis and therapeutic options in this population. Liver biopsy represents the reference standard for fibrosis staging. However, given its limitations and complications, different non-invasive methods have been developed recently for the in vivo quantification of fibrosis. Due to their precision and reliability, biomarkers' measurements derived from Ultrasound and Magnetic Resonance stand out. This article reviews the different acquisition techniques and image processing methods currently used in the evaluation of liver fibrosis, focusing on their diagnostic performance, applicability and clinical value. In order to properly interpret their results in the appropriate clinical context, it seems necessary to understand the techniques and their quality parameters, the standardization and validation of the measurement units and the quality control of the methodological problems. Copyright © 2017 SERAM. Publicado por Elsevier España, S.L.U. All rights reserved.

The History of Infant Formula: Quality, Safety, and Standard Methods.

PubMed

Wargo, Wayne F

2016-01-01

Food-related laws and regulations have existed since ancient times. Egyptian scrolls prescribed the labeling needed for certain foods. In ancient Athens, beer and wines were inspected for purity and soundness, and the Romans had a well-organized state food control system to protect consumers from fraud or bad produce. In Europe during the Middle Ages, individual countries passed laws concerning the quality and safety of eggs, sausages, cheese, beer, wine, and bread; some of these laws still exist today. But more modern dietary guidelines and food regulations have their origins in the latter half of the 19th century when the first general food laws were adopted and basic food control systems were implemented to monitor compliance. Around this time, science and food chemistry began to provide the tools to determine "purity" of food based primarily on chemical composition and to determine whether it had been adulterated in any way. Since the key chemical components of mammalian milk were first understood, infant formulas have steadily advanced in complexity as manufacturers attempt to close the compositional gap with human breast milk. To verify these compositional innovations and ensure product quality and safety, infant formula has become one of the most regulated foods in the world. The present paper examines the historical development of nutritional alternatives to breastfeeding, focusing on efforts undertaken to ensure the quality and safety from antiquity to present day. The impact of commercial infant formulas on global regulations is addressed, along with the resulting need for harmonized, fit-for-purpose, voluntary consensus standard methods.

Framework for establishing records control in hospitals as an ISO 9001 requirement.

PubMed

Al-Qatawneh, Lina

2017-02-13

Purpose The purpose of this paper is to present the process followed to control records in a Jordanian private community hospital as an ISO 9001:2008 standard requirement. Design/methodology/approach Under the hospital quality council's supervision, the quality management and development office staff were responsible for designing, planning and implementing the quality management system (QMS) using the ISO 9001:2008 standard. A policy for records control was established. An action plan for establishing the records control was developed and implemented. On completion, a coding system for records was specified to be used by hospital staff. Finally, an internal audit was performed to verify conformity to the ISO 9001:2008 standard requirements. Findings Successful certification by a neutral body ascertained that the hospital's QMS conformed to the ISO 9001:2008 requirements. A framework was developed that describes the records controlling process, which can be used by staff in any healthcare organization wanting to achieve ISO 9001:2008 accreditation. Originality/value Given the increased interest among healthcare organizations to achieve the ISO 9001 certification, the proposed framework for establishing records control is developed and is expected to be a valuable management tool to improve and sustain healthcare quality.

Kaizen method for esophagectomy patients: improved quality control, outcomes, and decreased costs.

PubMed

Iannettoni, Mark D; Lynch, William R; Parekh, Kalpaj R; McLaughlin, Kelley A

2011-04-01

The majority of costs associated with esophagectomy are related to the initial 3 days of hospital stay requiring intensive care unit stays, ventilator support, and intraoperative time. Additional costs arise from hospital-based services. The major cost increases are related to complications associated with the procedure. We attempted to define these costs and identify expense management by streamlining care through strict adherence to patient care maps, operative standardization, and rapid discharge planning to reduce variability. Utilizing methods of Kaizen philosophy we evaluated all processes related to the entire experience of esophageal resection. This process has taken over 5 years to achieve, with quality and cost being tracked over this time period. Cost analysis included expenses related to intensive care unit, anesthesia, disposables, and hospital services. Quality improvement measures were related to intraoperative complications, in-hospital complications, and postoperative outcomes. The Institutional Review Board approved the use of anonymous data from standard clinical practice because no additional treatment was planned (observational study). Utilizing a continuous process improvement methodology, a 43% reduction in cost per case has been achieved with a significant increase in contribution margin for esophagectomy. The length of stay has been reduced from 14 days to 5. With intraoperative and postoperative standardization the leak rate has dropped from 12% to less than 3% to no leaks in our current Kaizen modification of care in our last 64 patients. Utilizing lean manufacturing techniques and continuous process evaluation we have attempted to eliminate variability, standardized the phases of care resulting in improved outcomes, decreased length of stay, and improved contribution margins. These Kaizen improvements require continuous interventions, strict adherence to care maps, and input from all levels for quality improvements. Copyright © 2011 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Evolution of microbiological analytical methods for dairy industry needs

PubMed Central

Sohier, Danièle; Pavan, Sonia; Riou, Armelle; Combrisson, Jérôme; Postollec, Florence

2014-01-01

Traditionally, culture-based methods have been used to enumerate microbial populations in dairy products. Recent developments in molecular methods now enable faster and more sensitive analyses than classical microbiology procedures. These molecular tools allow a detailed characterization of cell physiological states and bacterial fitness and thus, offer new perspectives to integration of microbial physiology monitoring to improve industrial processes. This review summarizes the methods described to enumerate and characterize physiological states of technological microbiota in dairy products, and discusses the current deficiencies in relation to the industry’s needs. Recent studies show that Polymerase chain reaction-based methods can successfully be applied to quantify fermenting microbes and probiotics in dairy products. Flow cytometry and omics technologies also show interesting analytical potentialities. However, they still suffer from a lack of validation and standardization for quality control analyses, as reflected by the absence of performance studies and official international standards. PMID:24570675

Evolution of microbiological analytical methods for dairy industry needs.

PubMed

Sohier, Danièle; Pavan, Sonia; Riou, Armelle; Combrisson, Jérôme; Postollec, Florence

2014-01-01

Traditionally, culture-based methods have been used to enumerate microbial populations in dairy products. Recent developments in molecular methods now enable faster and more sensitive analyses than classical microbiology procedures. These molecular tools allow a detailed characterization of cell physiological states and bacterial fitness and thus, offer new perspectives to integration of microbial physiology monitoring to improve industrial processes. This review summarizes the methods described to enumerate and characterize physiological states of technological microbiota in dairy products, and discusses the current deficiencies in relation to the industry's needs. Recent studies show that Polymerase chain reaction-based methods can successfully be applied to quantify fermenting microbes and probiotics in dairy products. Flow cytometry and omics technologies also show interesting analytical potentialities. However, they still suffer from a lack of validation and standardization for quality control analyses, as reflected by the absence of performance studies and official international standards.

Improving data quality in the linked open data: a survey

NASA Astrophysics Data System (ADS)

Hadhiatma, A.

2018-03-01

The Linked Open Data (LOD) is “web of data”, a different paradigm from “web of document” commonly used today. However, the huge LOD still suffers from data quality problems such as completeness, consistency, and accuracy. Data quality problems relate to designing effective methods both to manage and to retrieve information at various data quality levels. Based on review from papers and journals, addressing data quality requires some standards functioning to (1) identification of data quality problems, (2) assessment of data quality for a given context, and (3) correction of data quality problems. However, mostly the methods and strategies dealing with the LOD data quality were not as an integrative approach. Hence, based on those standards and an integrative approach, there are opportunities to improve the LOD data quality in the term of incompleteness, inaccuracy and inconsistency, considering to its schema and ontology, namely ontology refinement. Moreover, the term of the ontology refinement means that it copes not only to improve data quality but also to enrich the LOD. Therefore, it needs (1) a standard for data quality assessment and evaluation which is more appropriate to the LOD; (2) a framework of methods based on statistical relational learning that can improve the correction of data quality problems as well as enrich the LOD.

Simultaneous Determination of Ten Constituents in Chaiqin Qingning Capsule by High-performance Liquid Chromatography Coupled with Triple-quadrupole Mass Spectrometry.

PubMed

Li, Ting Yu; Huo, Xiao Kui; Zheng, Lu; Wang, Chao; Cong, Hai Jian; Xiang, Ting; Zhang, Lin; Zhang, Bao Jing; Huang, Shan Shan; Wu, Bin; Li, Xin Yu

2017-01-01

Chaiqin Qingning Capsule (CQQNC) was a prescription of Traditional Chinese Medicine with the effects of clearing away heat and removing toxin, harmonizing the exterior and interior, it was widely used in Asian, for example, China and Japan, different batches of the raws materials and different processing time may be the vital factor which raised a challenge to control the quality of the CQQNC. In this experiment, a high-performance liquid chromatography-mass spectrometry/MS (HPLC-MS/MS) method was developed to simultaneously determine ten bioactive components for the quality control of CQQNC. Chromatographic separation was achieved using an XBridge BEH C18 column (150 mm × 4.6 mm, 2.5 μm) with a mobile phase composed of 10 mm aqueous ammonium acetate and acetonitrile using a gradient elution in 20 min. This study was conducted by multiple reaction monitoring mode through electrospray ionization resource with a negative ionization mode. The established method was validated with good performance of precision, accuracy, stability, and reproducibility and was utilized to simultaneously quantify ten constituents of CQQNC obtained from seven different batches. It is the first time to report the rapid and simultaneous analysis of the ten compounds in CQQNC by HPLC-MS/MS and apply to determine 10 constituents in 7 batches of CQQNC bought from drug store in china. This method could be considered as good quality criteria to control the quality of CQQNC. In this paper, a simple, specific, and rapid high-performance liquid chromatogram coupled with triple-quadrupole mass spectrometry method for simultaneous quantification of ten constituents in Chaiqin Qingning Capsule has been developed for the first time. This method could be considered as good quality criteria to control the quality of CQQNC. Abbreviations used: CHM: Chinese herbal medicine; TCM: Traditional Chinese Medicine; CQQNC: Triple-quadrupole mass spectrometry Chaiqin Qingning Capsules; HPLC-MS/MS: High liquid chromatography equipped with tandem mass spectrometry; ESI: Electrospray ionization; DP: Declustering potential; CE: Collision energy; RSD: Relative standard deviation; LOD: Limit of detection; LOQ: Limit of quantity.

Natural cycle in vitro fertilisation (IVF) for subfertile couples.

PubMed

Allersma, Thomas; Farquhar, Cindy; Cantineau, Astrid E P

2013-08-30

Subfertility affects 15% to 20% of couples trying to conceive. In vitro fertilisation (IVF) is one of the assisted reproduction techniques developed to improve chances of achieving pregnancy. In the standard IVF method with controlled ovarian hyperstimulation (COH), growth and development of multiple follicles are stimulated by using gonadotrophins, often combined with a gonadotrophin-releasing hormone (GnRH) agonist or antagonist. Although it is an established method of conception for subfertile couples, the treatment is expensive and has a high risk of adverse effects. Studies have shown that IVF in a natural cycle (NC) or a modified natural cycle (MNC) might be a promising low risk and low cost alternative to the standard stimulated IVF treatment since the available dominant follicle of each cycle is used. In this review, we included available randomised controlled studies comparing natural cycle IVF (NC and MNC) with standard IVF. To compare the efficacy and safety of natural cycle IVF (including both NC-IVF and MNC-IVF) with controlled ovarian hyperstimulation IVF (COH-IVF) in subfertile couples. An extended search including of the Menstrual Disorders and Subfertility Group (MDSG) Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, ClinicalTrials.gov, conference abstracts in the Web of Knowledge, the World Health Organization International Trials Registry Platform search portal, LILACS database, PubMed and the OpenSIGLE database was conducted according to Cochrane guidelines. The last search was on 31st July 2013. All randomised controlled trials (RCTs) comparing either natural cycle IVF or modified natural cycle IVF versus standard IVF in subfertile couples were included. Data selection and extraction and risk of bias assessment were carried out independently by two authors (TA and AC). The primary outcome measures were live birth rate and ovarian hyperstimulation syndrome (OHSS) rate per randomised woman. We calculated Mantel-Haenszel odds ratios for each dichotomous outcome and either the mean difference or the standardised mean difference (SMD) for continuous outcomes, with 95% confidence intervals (CIs). A fixed effect model was used unless there was substantial heterogeneity, in which case a random effects model was used. Six randomised controlled trials with a total of 788 women were included. The largest of these trials included 396 women eligible for this review.No evidence of a statistically significant difference was found between natural cycle and standard IVF in live birth rates (OR 0.68, 95% CI 0.46 to 1.01, two studies, 425 women, I(2)= 0%, moderate quality evidence). The evidence suggests that for a woman with a 53% chance of live birth using standard IVF, the chance using natural cycle IVF would range from 34% to 53%. There was no evidence of a statistically significant difference between natural cycle and standard IVF in rates of OHSS (OR 0.19, 95% CI 0.01 to 4.06, one study, 60 women, very low quality evidence), clinical pregnancy (OR 0.52 95% CI 0.17 to 1.61, 4 studies, 351 women, I(2)=63%, low quality evidence), ongoing pregnancy (OR 0.72, 95% CI 0.50 to 1.05, three studies, 485 women, I(2)=0%, moderate quality evidence), multiple pregnancy (OR 0.76, 95% CI 0.25 to 2.31, 2 studies, 527 women, I(2)=0%, very low quality evidence), gestational abnormalities (OR 0.44 95% CI 0.03 to 5.93, 1 study, 18 women, very low quality evidence) or cycle cancellations (OR 8.98, 95% CI 0.20 to 393.66, 2 studies, 159 women, I(2)=83%, very low quality evidence). One trial reported that the oocyte retrieval rate was significantly lower in the natural cycle group (MD -4.40, 95% CI -7.87 to -0.93, 60 women, very low quality evidence). There were insufficient data to draw any conclusions about rates of treatment cancellation. Findings on treatment costs were inconsistent and more data are awaited. The evidence was limited by imprecision. Findings for pregnancy rate and for cycle cancellation were sensitive to the choice of statistical model: for these outcomes, use of a fixed effect model suggested a benefit for the standard IVF group. Moreover the largest trial has not yet completed follow up, though data have been reported for over 95% of women. Further evidence from well conducted large trials is awaited on natural cycle IVF treatment. Future trials should compare natural cycle IVF with standard IVF. Outcomes should include cumulative live birth and pregnancy rates, the number of treatment cycles necessary to reach live birth, treatment costs and adverse effects.

Information Quality in Regulatory Decision Making: Peer Review versus Good Laboratory Practice.

PubMed

McCarty, Lynn S; Borgert, Christopher J; Mihaich, Ellen M

2012-07-01

There is an ongoing discussion on the provenance of toxicity testing data regarding how best to ensure its validity and credibility. A central argument is whether journal peer-review procedures are superior to Good Laboratory Practice (GLP) standards employed for compliance with regulatory mandates. We sought to evaluate the rationale for regulatory decision making based on peer-review procedures versus GLP standards. We examined pertinent published literature regarding how scientific data quality and validity are evaluated for peer review, GLP compliance, and development of regulations. Some contend that peer review is a coherent, consistent evaluative procedure providing quality control for experimental data generation, analysis, and reporting sufficient to reliably establish relative merit, whereas GLP is seen as merely a tracking process designed to thwart investigator corruption. This view is not supported by published analyses pointing to subjectivity and variability in peer-review processes. Although GLP is not designed to establish relative merit, it is an internationally accepted quality assurance, quality control method for documenting experimental conduct and data. Neither process is completely sufficient for establishing relative scientific soundness. However, changes occurring both in peer-review processes and in regulatory guidance resulting in clearer, more transparent communication of scientific information point to an emerging convergence in ensuring information quality. The solution to determining relative merit lies in developing a well-documented, generally accepted weight-of-evidence scheme to evaluate both peer-reviewed and GLP information used in regulatory decision making where both merit and specific relevance inform the process.

College quality and hourly wages: evidence from the self-revelation model, sibling models and instrumental variables.

PubMed

Borgen, Nicolai T

2014-11-01

This paper addresses the recent discussion on confounding in the returns to college quality literature using the Norwegian case. The main advantage of studying Norway is the quality of the data. Norwegian administrative data provide information on college applications, family relations and a rich set of control variables for all Norwegian citizens applying to college between 1997 and 2004 (N = 141,319) and their succeeding wages between 2003 and 2010 (676,079 person-year observations). With these data, this paper uses a subset of the models that have rendered mixed findings in the literature in order to investigate to what extent confounding biases the returns to college quality. I compare estimates obtained using standard regression models to estimates obtained using the self-revelation model of Dale and Krueger (2002), a sibling fixed effects model and the instrumental variable model used by Long (2008). Using these methods, I consistently find increasing returns to college quality over the course of students' work careers, with positive returns only later in students' work careers. I conclude that the standard regression estimate provides a reasonable estimate of the returns to college quality. Copyright © 2014 Elsevier Inc. All rights reserved.

Quality assurance, training, and certification in ozone air pollution studies

Treesearch

Susan Schilling; Paul Miller; Brent Takemoto

1996-01-01

Uniform, or standard, measurement methods of data are critical to projects monitoring change to forest systems. Standardized methods, with known or estimable errors, contribute greatly to the confidence associated with decisions on the basis of field data collections (Zedaker and Nicholas 1990). Quality assurance (QA) for the measurement process includes operations and...

A Methodological Analysis of Randomized Clinical Trials of Computer-Assisted Therapies for Psychiatric Disorders: Toward Improved Standards for an Emerging Field

PubMed Central

Kiluk, Brian D.; Sugarman, Dawn E.; Nich, Charla; Gibbons, Carly J.; Martino, Steve; Rounsaville, Bruce J.; Carroll, Kathleen M.

2013-01-01

Objective Computer-assisted therapies offer a novel, cost-effective strategy for providing evidence-based therapies to a broad range of individuals with psychiatric disorders. However, the extent to which the growing body of randomized trials evaluating computer-assisted therapies meets current standards of methodological rigor for evidence-based interventions is not clear. Method A methodological analysis of randomized clinical trials of computer-assisted therapies for adult psychiatric disorders, published between January 1990 and January 2010, was conducted. Seventy-five studies that examined computer-assisted therapies for a range of axis I disorders were evaluated using a 14-item methodological quality index. Results Results indicated marked heterogeneity in study quality. No study met all 14 basic quality standards, and three met 13 criteria. Consistent weaknesses were noted in evaluation of treatment exposure and adherence, rates of follow-up assessment, and conformity to intention-to-treat principles. Studies utilizing weaker comparison conditions (e.g., wait-list controls) had poorer methodological quality scores and were more likely to report effects favoring the computer-assisted condition. Conclusions While several well-conducted studies have indicated promising results for computer-assisted therapies, this emerging field has not yet achieved a level of methodological quality equivalent to those required for other evidence-based behavioral therapies or pharmacotherapies. Adoption of more consistent standards for methodological quality in this field, with greater attention to potential adverse events, is needed before computer-assisted therapies are widely disseminated or marketed as evidence based. PMID:21536689

Drinking water quality standards and standard tests: Worldwide. (Latest citations from the Food Science and Technology Abstracts database). Published Search

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

Not Available

1993-06-01

The bibliography contains citations concerning standards and standard tests for water quality in drinking water sources, reservoirs, and distribution systems. Standards from domestic and international sources are presented. Glossaries and vocabularies that concern water quality analysis, testing, and evaluation are included. Standard test methods for individual elements, selected chemicals, sensory properties, radioactivity, and other chemical and physical properties are described. Discussions for proposed standards on new pollutant materials are briefly considered. (Contains a minimum of 203 citations and includes a subject term index and title list.)

[Effect of manual cleaning and machine cleaning for dental handpiece].

PubMed

Zhou, Xiaoli; Huang, Hao; He, Xiaoyan; Chen, Hui; Zhou, Xiaoying

2013-08-01

Comparing the dental handpiece' s cleaning effect between manual cleaning and machine cleaning. Eighty same contaminated dental handpieces were randomly divided into experimental group and control group, each group contains 40 pieces. The experimental group was treated by full automatic washing machine, and the control group was cleaned manually. The cleaning method was conducted according to the operations process standard, then ATP bioluminescence was used to test the cleaning results. Average relative light units (RLU) by ATP bioluminescence detection were as follows: Experimental group was 9, control group was 41. The two groups were less than the recommended RLU value provided by the instrument manufacturer (RLU < or = 45). There was significant difference between the two groups (P < 0.05). The cleaning quality of the experimental group was better than that of control group. It is recommended that the central sterile supply department should clean dental handpieces by machine to ensure the cleaning effect and maintain the quality.

Expert database system for quality control

NASA Astrophysics Data System (ADS)

Wang, Anne J.; Li, Zhi-Cheng

1993-09-01

There are more competitors today. Markets are not homogeneous they are fragmented into increasingly focused niches requiring greater flexibility in the product mix shorter manufacturing production runs and above allhigher quality. In this paper the author identified a real-time expert system as a way to improve plantwide quality management. The quality control expert database system (QCEDS) by integrating knowledge of experts in operations quality management and computer systems use all information relevant to quality managementfacts as well as rulesto determine if a product meets quality standards. Keywords: expert system quality control data base

[Effectiveness of acupuncture in postoperative ileus: a systematic review and Meta-analysis].

PubMed

Cheong, Kah Bik; Zhang, Jiping; Huang, Yong

2016-06-01

To conduct a systematic review and Meta-analysis of the effectiveness of acupuncture and common acupoint selection for postoperative ileus (POI). Randomized controlled trials (RCTs) comparing acupuncture and non-acupuncture treatment were identified from the databases PubMed, Cochrane, EBSCO (Academic Source Premier and MEDLINE), Ovid (including Evidence-Based Medicine Reviews), China National Knowledge Infrastructure, and Wanfang Data. The data from eligible studies were extracted and a Meta-analysis performed using a fixed-effects model. Results were expressed as relative risk (RR) for dichotomous data, and 95% CI (confidence intervals) were calculated. Each trial was evaluated using the CONSORT (Consolidated Standards of Reporting Trials) and STRICTA (STandards for Reporting Interventions in Controlled Trials of Acupuncture) guideline . The quality of the study was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. Of the 69 studies screened, eight RCTs were included for review. Among these, four RCTs (with a total of 123 patients in the intervention groups and 124 patients in the control groups) met the criteria for Meta-analysis. The Meta-analysis results indicated that acupuncture combined with usual care showed a significantly higher total effective rate than the control condition (usual care) (RR 1.09, 95% CI 1.01, 1.18; P = 0.02). Zusanli (ST 36) and Shangjuxu (ST 37) were the most common acupoints selected. However, the quality of the studies was generally low, as they did not emphasize the use of blinding. The results suggested that acupuncture might be effective in improving POI; however, a definite conclusion could not be drawn because of the low quality of trials. Further large-scale, high-quality randomized clinical trials are needed to validate these findings and to develop a standardized method of treatment. We hope that the present results will lead to improved research, resulting in better patient care worldwide.

The Effect of Professional Learning Activities on Implementation of California's Quality Professional Learning Standards in Alignment with the Local Control Funding Formula Priority 2

ERIC Educational Resources Information Center

Pinotti, Sadie

2017-01-01

The purpose of this Delphi study was to identify the professional learning activities that experts perceive are necessary for local education agencies (LEAs) to effectively implement California's Quality Professional Learning Standards (QPLS) in alignment with the Local Control Funding Formula (LCFF) Priority 2. The study also examined the degree…

The standardization of urine particle counting in medical laboratories--a Polish experience with the EQA programme.

PubMed

Cwiklińska, Agnieszka; Kąkol, Judyta; Kuchta, Agnieszka; Kortas-Stempak, Barbara; Pacanis, Anastasis; Rogulski, Jerzy; Wróblewska, Małgorzata

2012-02-01

Given the common problems with the standardization of urine particle counting methods and the great variability in the results obtained by Polish laboratories under international Labquality External Quality Assessment (EQA), we initiated educational recovery activities. Detailed instructions on how to perform the standardized examination were sent to EQA participants, as was a questionnaire forms which enabled information to be gathered in respect to the procedures being applied. Laboratory results were grouped according to the method declared on the EQA 'Result' form or according to a manual examination procedure established on the basis of the questionnaire. The between-laboratory CVs for leukocyte and erythrocyte counts were calculated for each group and compared using the Mann-Whitney test. Significantly lower between-laboratory CVs (p = 0.03) were achieved for leukocyte counting among the laboratories that analysed control specimens in accordance with standardized procedures as compared with those which used non-standardized procedures. We also observed a visible lower variability for erythrocyte counting. Unfortunately despite our activities, only a few of the Polish laboratories applied the standardized examination procedures, and only 29% of the results could have been considered to be standardized (16% - manual methods, 13% - automated systems). The standardization of urine particle counting methods continues to be a significant problem in medical laboratories and requires further recovery activities which can be conducted using the EQA scheme.

Normalization of cortical thickness measurements across different T1 magnetic resonance imaging protocols by novel W-Score standardization.

PubMed

Chung, Jinyong; Yoo, Kwangsun; Lee, Peter; Kim, Chan Mi; Roh, Jee Hoon; Park, Ji Eun; Kim, Sang Joon; Seo, Sang Won; Shin, Jeong-Hyeon; Seong, Joon-Kyung; Jeong, Yong

2017-10-01

The use of different 3D T1-weighted magnetic resonance (T1 MR) imaging protocols induces image incompatibility across multicenter studies, negating the many advantages of multicenter studies. A few methods have been developed to address this problem, but significant image incompatibility still remains. Thus, we developed a novel and convenient method to improve image compatibility. W-score standardization creates quality reference values by using a healthy group to obtain normalized disease values. We developed a protocol-specific w-score standardization to control the protocol effect, which is applied to each protocol separately. We used three data sets. In dataset 1, brain T1 MR images of normal controls (NC) and patients with Alzheimer's disease (AD) from two centers, acquired with different T1 MR protocols, were used (Protocol 1 and 2, n = 45/group). In dataset 2, data from six subjects, who underwent MRI with two different protocols (Protocol 1 and 2), were used with different repetition times, echo times, and slice thicknesses. In dataset 3, T1 MR images from a large number of healthy normal controls (Protocol 1: n = 148, Protocol 2: n = 343) were collected for w-score standardization. The protocol effect and disease effect on subjects' cortical thickness were analyzed before and after the application of protocol-specific w-score standardization. As expected, different protocols resulted in differing cortical thickness measurements in both NC and AD subjects. Different measurements were obtained for the same subject when imaged with different protocols. Multivariate pattern difference between measurements was observed between the protocols. Classification accuracy between two protocols was nearly 90%. After applying protocol-specific w-score standardization, the differences between the protocols substantially decreased. Most importantly, protocol-specific w-score standardization reduced both univariate and multivariate differences in the images while maintaining the AD disease effect. Compared to conventional regression methods, our method showed the best performance for in terms of controlling the protocol effect while preserving disease information. Protocol-specific w-score standardization effectively resolved the concerns of conventional regression methods. It showed the best performance for improving the compatibility of a T1 MR post-processed feature, cortical thickness. Copyright © 2017 Elsevier Inc. All rights reserved.

Water Quality Assessment and Management

EPA Pesticide Factsheets

Overview of Clean Water Act (CWA) restoration framework including; water quality standards, monitoring/assessment, reporting water quality status, TMDL development, TMDL implementation (point & nonpoint source control)

[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.

Interferometric measurement of displacements and displacement velocities for nondestructive quality control

NASA Astrophysics Data System (ADS)

Shpeĭzman, V. V.; Peschanskaya, N. N.

2007-07-01

It is shown that the interferometric measurement of small displacements and small-displacement velocities can be used to determine internal stresses or the stresses induced by an applied load in solids and to control structural changes in them. The interferometric method based on the measurement of the reaction of a solid to a small perturbation in its state of stress is applied to determine stresses from the deviation of the reaction to perturbations from that in the standard stress-free case. For structural control, this method is employed to study the specific features of the characteristics of microplastic deformation that appear after material treatment or operation and manifest themselves in the temperature and force dependences of the rate of a small inelastic strain.

Quality control of positron emission tomography radiopharmaceuticals: An institutional experience.

PubMed

Shukla, Jaya; Vatsa, Rakhee; Garg, Nitasha; Bhusari, Priya; Watts, Ankit; Mittal, Bhagwant R

2013-10-01

To study quality control parameters of routinely prepared positron emission tomography (PET) radiopharmaceuticals. Three PET radiopharmaceuticals fluorine-18 fluorodeoxyglucose (F-18 FDG), N-13 ammonia (N-13 NH3), and Ga-68 DOTATATE (n = 25 each), prepared by standardized protocols were used. The radionuclide purity, radiochemical purity, residual solvents, pH, endotoxins, and sterility of these radiopharmaceuticals were determined. The physical half-life of radionuclide in radiopharmaceuticals, determined by both graphical and formula method, demonstrated purity of radionuclides used. pH of all PET radiopharmaceuticals used was in the range of 5-6.5. No microbial growth was observed in radiopharmaceutical preparations. The residual solvents, chemical impurity, and pyrogens were within the permissible limits. All three PET radiopharmaceuticals were safe for intravenous administration.

[Quality control and assessment of qualitative interview in health care research].

PubMed

Xie, Yan-ming; Liao, Xing

2008-07-01

It is not finally concluded how to standardize the use of qualitative research in the world. Qualitative researchers disagree with each other about this issue. As we know, there have been a large number of articles written in different ways about qualitative research due to the "flexibility", one of its features. Qualitative research is quite different from quantitative research which is easy to control its quality and quality assessment. A series of criteria has been set up for quantitative research. However qualitative research needs to be improved in these aspects, in which qualitative interviews are mostly used at home and abroad at present. Hence, it becomes an important and urgent issue for qualitative researchers to standardly control and assess the quality of qualitative interview.

Gap Analysis for Chinese Drug Control Institutes to Achieve the Standards of World Health Organization Medicine Prequalification.

PubMed

Mao, Xin; Yang, Yue

2017-02-01

The study aims to explore the challenges and the gaps faced by Chinese Drug Control Institutes in achieving the standards of World Health Organization (WHO) Medicine Prequalification. The study was undertaken with 6 Provincial Drug Control Institutes in China from November 2012 to November 2013. The study assessed key elements required to comply with WHO Good Practices for Pharmaceutical Quality Control Laboratories (GPPQCL). For GPPQCL, the study found gaps in quality management system, control of documentation, data-processing equipment, premises and equipment, contracts, reagents (water), reference substances and reference materials, calibration, verification of performance and qualification of equipment, instruments and other devices, analytical worksheet, evaluation of test results, personnel, and validation of analytical procedures. The study indicates that gaps are attributed to differences between the standards of Chinese Accreditation Standards and WHO-GPPQCL. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Design of Road Pavement Using Recycled Aggregate

NASA Astrophysics Data System (ADS)

Remišová, Eva; Decký, Martin; Mikolaš, Milan; Hájek, Matej; Kovalčík, Luboš; Mečár, Martin

2016-10-01

The presented article gives special attention to codified clauses of the road construction law, the relevant clauses of the standards and technical regulations to design and control the quality of recycled aggregate constructions. The article also presents the authors’ suggestions to design of earth constructions and pavements of roads according to the Slovak technical standards, technical regulations and objectively determined results of research and development of road infrastructure. The article presents a comparison of the mechanical characteristics measurements of the structural layers of road pavements built from the recycled and natural aggregate. It also presents correlation functions of results obtained from in situ and in laboratory CBR (Californian Bearing Ratio) measuring, representing the world's most widely used control method of bearing capacity of mentioned construction layers.

NHEXAS PHASE I REGION 5 STUDY--STANDARD OPERATING PROCEDURE--HANDLING QUALITY CONTROL SAMPLES IN THE FIELD (RTI/ACS-AP-209-090)

EPA Science Inventory

This protocol describes how quality control samples should be handled in the field, and was designed as a quick reference source for the field staff. The protocol describes quality control samples for air-VOCs, air-particles, water samples, house dust, soil, urine, blood, hair, a...

Symptoms and quality of life in patients with suspected angina undergoing CT coronary angiography: a randomised controlled trial

PubMed Central

Hunter, Amanda; Shah, Anoop; Assi, Valentina; Lewis, Stephanie; Mangion, Kenneth; Berry, Colin; Boon, Nicholas A; Clark, Elizabeth; Flather, Marcus; Forbes, John; McLean, Scott; Roditi, Giles; van Beek, Edwin JR; Timmis, Adam D; Newby, David E

2017-01-01

Background In patients with suspected angina pectoris, CT coronary angiography (CTCA) clarifies the diagnosis, directs appropriate investigations and therapies, and reduces clinical events. The effect on patient symptoms is currently unknown. Methods In a prospective open-label parallel group multicentre randomised controlled trial, 4146 patients with suspected angina due to coronary heart disease were randomised 1:1 to receive standard care or standard care plus CTCA. Symptoms and quality of life were assessed over 6 months using the Seattle Angina Questionnaire and Short Form 12. Results Baseline scores indicated mild physical limitation (74±0.4), moderate angina stability (44±0.4), modest angina frequency (68±0.4), excellent treatment satisfaction (92±0.2) and moderate impairment of quality of life (55±0.3). Compared with standard care alone, CTCA was associated with less marked improvements in physical limitation (difference −1.74 (95% CIs, −3.34 to −0.14), p=0.0329), angina frequency (difference −1.55 (−2.85 to −0.25), p=0.0198) and quality of life (difference −3.48 (−4.95 to −2.01), p<0.0001) at 6 months. For patients undergoing CTCA, improvements in symptoms were greatest in those diagnosed with normal coronary arteries or who had their preventative therapy discontinued, and least in those with moderate non-obstructive disease or had a new prescription of preventative therapy (p<0.001 for all). Conclusions While improving diagnosis, treatment and outcome, CTCA is associated with a small attenuation of the improvements in symptoms and quality of life due to the detection of moderate non-obstructive coronary artery disease. Trial registration number: NCT01149590. PMID:28246175

[Study thought of pharmaceutical preparations quality standards by dynamic quality control technology].

PubMed

Yu, Dan-Hong; Mao, Chen-Mei; Lv, Cheng-Zhe; Jin, Hui-Zhen; Yao, Xin; Jia, Xiao-Bin

2014-07-01

Pharmaceutical preparations, particularly as a "secret recipe" of traditional Chinese medicine in medical institutions, are the product of China's medical and health industry, and they are also an important means of competing of different medical institutions. Although pharmaceutical preparations have advantages and characteristics than institutes for drug and pharmaceutical companies, the quality standards of pharmaceutical preparations in medical institutions has not reached the desired level over the years. As we all know, the quality of pharmaceutical preparations is important to ensure the efficacy, especially under the environment of people pay more sttention on drug safety and effectiveness and contry increase emphasis on the stste of pharmaceutical preparations. In view of this, we will improve the grade, stability, and clinical efficacy of pharmaceutical preparations by the advanced equipment, testing instruments and the process dynamic quality control technology. Finally, we hope we can provide new ideas for the quality control of pharmaceutical preparations.

Electrical Stimulation for Pressure Injuries: A Health Technology Assessment

PubMed Central

Lambrinos, Anna; Falk, Lindsey; Ali, Arshia; Holubowich, Corinne; Walter, Melissa

2017-01-01

Background Pressure injuries (bedsores) are common and reduce quality of life. They are also costly and difficult to treat. This health technology assessment evaluates the effectiveness, cost-effectiveness, budget impact, and lived experience of adding electrical stimulation to standard wound care for pressure injuries. Methods We conducted a systematic search for studies published to December 7, 2016, limited to randomized and non–randomized controlled trials examining the effectiveness of electrical stimulation plus standard wound care versus standard wound care alone for patients with pressure injuries. We assessed the quality of evidence through Grading of Recommendations Assessment, Development, and Evaluation (GRADE). In addition, we conducted an economic literature review and a budget impact analysis to assess the cost-effectiveness and affordability of electrical stimulation for treatment of pressure ulcers in Ontario. Given uncertainties in clinical evidence and resource use, we did not conduct a primary economic evaluation. Finally, we conducted qualitative interviews with patients and caregivers about their experiences with pressure injuries, currently available treatments, and (if applicable) electrical stimulation. Results Nine randomized controlled trials and two non–randomized controlled trials were found from the systematic search. There was no significant difference in complete pressure injury healing between adjunct electrical stimulation and standard wound care. There was a significant difference in wound surface area reduction favouring electrical stimulation compared with standard wound care. The only study on cost-effectiveness of electrical stimulation was partially applicable to the patient population of interest. Therefore, the cost-effectiveness of electrical stimulation cannot be determined. We estimate that the cost of publicly funding electrical stimulation for pressure injuries would be $0.77 to $3.85 million yearly for the next 5 years. Patients and caregivers reported that pressure injuries were burdensome and reduced their quality of life. Patients and caregivers also noted that electrical stimulation seemed to reduce the time it took the wounds to heal. Conclusions While electrical stimulation is safe to use (GRADE quality of evidence: high) there is uncertainty about whether it improves wound healing (GRADE quality of evidence: low). In Ontario, publicly funding electrical stimulation for pressure injuries could result in extra costs of $0.77 to $3.85 million yearly for the next 5 years. PMID:29201261

Development and validation of a reversed-phase ion-pair high-performance liquid chromatographic method for the determination of risedronate in pharmaceutical preparations.

PubMed

Kyriakides, Demetra; Panderi, Irene

2007-02-12

A stability indicating, reversed-phase ion-pair high-performance liquid chromatographic method was developed and validated for the determination of risedronate in pharmaceutical dosage forms. The determination was performed on a BDS C(18) analytical column (250 mm x 4.6 mm i.d., 5 microm particle size); the mobile phase consisted of 0.005 M tetrabutylammonium hydroxide and 0.005 M pyrophosphate sodium (pH 7.0) mixed with acetonitrile in a ratio (78:22, v/v) and pumped at a flow rate 1.00 mL min(-1). The ultraviolet (UV) detector was operated at 262 nm. The retention times of magnesium ascorbyl phosphate, which was used as internal standard and risedronate were 4.94 and 5.95 min, respectively. The calibration graph was ranged from 2.50 to 20.00 microg mL(-1), while detection and quantitation limits were found to be 0.48 and 1.61 microg mL(-1), respectively. The intra- and inter-day percentage relative standard deviations, %R.S.D., were less than 5.9%, while the relative percentage error, %E(r), was less than 0.4%. The method was applied to the quality control of commercial tablets and content uniformity test and proved to be suitable for rapid and reliable quality control.

A case study: application of statistical process control tool for determining process capability and sigma level.

PubMed

Chopra, Vikram; Bairagi, Mukesh; Trivedi, P; Nagar, Mona

2012-01-01

Statistical process control is the application of statistical methods to the measurement and analysis of variation process. Various regulatory authorities such as Validation Guidance for Industry (2011), International Conference on Harmonisation ICH Q10 (2009), the Health Canada guidelines (2009), Health Science Authority, Singapore: Guidance for Product Quality Review (2008), and International Organization for Standardization ISO-9000:2005 provide regulatory support for the application of statistical process control for better process control and understanding. In this study risk assessments, normal probability distributions, control charts, and capability charts are employed for selection of critical quality attributes, determination of normal probability distribution, statistical stability, and capability of production processes, respectively. The objective of this study is to determine tablet production process quality in the form of sigma process capability. By interpreting data and graph trends, forecasting of critical quality attributes, sigma process capability, and stability of process were studied. The overall study contributes to an assessment of process at the sigma level with respect to out-of-specification attributes produced. Finally, the study will point to an area where the application of quality improvement and quality risk assessment principles for achievement of six sigma-capable processes is possible. Statistical process control is the most advantageous tool for determination of the quality of any production process. This tool is new for the pharmaceutical tablet production process. In the case of pharmaceutical tablet production processes, the quality control parameters act as quality assessment parameters. Application of risk assessment provides selection of critical quality attributes among quality control parameters. Sequential application of normality distributions, control charts, and capability analyses provides a valid statistical process control study on process. Interpretation of such a study provides information about stability, process variability, changing of trends, and quantification of process ability against defective production. Comparative evaluation of critical quality attributes by Pareto charts provides the least capable and most variable process that is liable for improvement. Statistical process control thus proves to be an important tool for six sigma-capable process development and continuous quality improvement.

Evaluation of 3 dental unit waterline contamination testing methods

PubMed Central

Porteous, Nuala; Sun, Yuyu; Schoolfield, John

2015-01-01

Previous studies have found inconsistent results from testing methods used to measure heterotrophic plate count (HPC) bacteria in dental unit waterline (DUWL) samples. This study used 63 samples to compare the results obtained from an in-office chairside method and 2 currently used commercial laboratory HPC methods (Standard Methods 9215C and 9215E). The results suggest that the Standard Method 9215E is not suitable for application to DUWL quality monitoring, due to the detection of limited numbers of heterotrophic organisms at the required 35°C incubation temperature. The results also confirm that while the in-office chairside method is useful for DUWL quality monitoring, the Standard Method 9215C provided the most accurate results. PMID:25574718

Differences between genomic-based and pedigree-based relationships in a chicken population, as a function of quality control and pedigree links among individuals.

PubMed

Wang, H; Misztal, I; Legarra, A

2014-12-01

This work studied differences between expected (calculated from pedigree) and realized (genomic, from markers) relationships in a real population, the influence of quality control on these differences, and their fit to current theory. Data included 4940 pure line chickens across five generations genotyped for 57,636 SNP. Pedigrees (5762 animals) were available for the five generations, pedigree starting on the first one. Three levels of quality control were used. With no quality control, mean difference between realized and expected relationships for different type of relationships was ≤ 0.04 with standard deviation ≤ 0.10. With strong quality control (call rate ≥ 0.9, parent-progeny conflicts, minor allele frequency and use of only autosomal chromosomes), these numbers reduced to ≤ 0.02 and ≤ 0.04, respectively. While the maximum difference was 1.02 with the complete data, it was only 0.18 with the latest three generations of genotypes (but including all pedigrees). Variation of expected minus realized relationships agreed with theoretical developments and suggests an effective number of loci of 70 for this population. When the pedigree is complete and as deep as the genotypes, the standard deviation of difference between the expected and realized relationships is around 0.04, all categories confounded. Standard deviation of differences larger than 0.10 suggests bad quality control, mistakes in pedigree recording or genotype labelling, or insufficient depth of pedigree. © 2014 Blackwell Verlag GmbH.

Development and validation of a stability-indicating gas chromatographic method for quality control of residual solvents in blonanserin: a novel atypical antipsychotic agent.

PubMed

Peng, Ming; Liu, Jin; Lu, Dan; Yang, Yong-Jian

2012-09-01

Blonanserin is a novel atypical antipsychotic agent for the treatment of schizophrenia. Ethyl alcohol, isopropyl alcohol and toluene are utilized in the synthesis route of this bulk drug. A new validated gas chromatographic (GC) method for the simultaneous determination of residual solvents in blonanserin is described in this paper. Blonanserin was dissolved in N, N-dimethylformamide to make a sample solution that was directly injected into a DB-624 column. A postrun oven temperature at 240°C for approximately 2 h after the analysis cycle was performed to wash out blonanserin residue in the GC column. Quantitation was performed by external standard analyses and the validation was carried out according to International Conference on Harmonization validation guidelines Q2A and Q2B. The method was shown to be specific (no interference in the blank solution), linear (correlation coefficients ≥0.99998, n = 10), accurate (average recoveries between 94.1 and 101.7%), precise (intra-day and inter-day precision ≤2.6%), sensitive (limit of detection ≤0.2 ng, and limit of quantitation ≤0.7 ng), robust (small variations of carrier gas flow, initial oven temperature, temperature ramping rate, injector and detector temperatures did not significantly affect the system suitability test parameters and peak areas) and stable (reference standard and sample solutions were stable over 48 h). This extensively validated method is ready to be used for the quality control of blonanserin.

Categorical Indicator Kriging for assessing the risk of groundwater nitrate pollution: the case of Vega de Granada aquifer (SE Spain).

PubMed

Chica-Olmo, Mario; Luque-Espinar, Juan Antonio; Rodriguez-Galiano, Victor; Pardo-Igúzquiza, Eulogio; Chica-Rivas, Lucía

2014-02-01

Groundwater nitrate pollution associated with agricultural activity is an important environmental problem in the management of this natural resource, as acknowledged by the European Water Framework Directive. Therefore, specific measures aimed to control the risk of water pollution by nitrates must be implemented to minimise its impact on the environment and potential risk to human health. The spatial probability distribution of nitrate contents exceeding a threshold or limit value, established within the quality standard, will be helpful to managers and decision-makers. A methodology based on non-parametric and non-linear methods of Indicator Kriging was used in the elaboration of a nitrate pollution categorical map for the aquifer of Vega de Granada (SE Spain). The map has been obtained from the local estimation of the probability that a nitrate content in an unsampled location belongs to one of the three categories established by the European Water Framework Directive: CL. 1 good quality [Min - 37.5 ppm], CL. 2 intermediate quality [37.5-50 ppm] and CL. 3 poor quality [50 ppm - Max]. The obtained results show that the areas exceeding nitrate concentrations of 50 ppm, poor quality waters, occupy more than 50% of the aquifer area. A great proportion of the area's municipalities are located in these poor quality water areas. The intermediate quality and good quality areas correspond to 21% and 28%, respectively, but with the highest population density. These results are coherent with the experimental data, which show an average nitrate concentration value of 72 ppm, significantly higher than the quality standard limit of 50 ppm. Consequently, the results suggest the importance of planning actions in order to control and monitor aquifer nitrate pollution. © 2013.

Landsat Image Map Production Methods at the U. S. Geological Survey

USGS Publications Warehouse

Kidwell, R.D.; Binnie, D.R.; Martin, S.

1987-01-01

To maintain consistently high quality in satellite image map production, the U. S. Geological Survey (USGS) has developed standard procedures for the photographic and digital production of Landsat image mosaics, and for lithographic printing of multispectral imagery. This paper gives a brief review of the photographic, digital, and lithographic procedures currently in use for producing image maps from Landsat data. It is shown that consistency in the printing of image maps is achieved by standardizing the materials and procedures that affect the image detail and color balance of the final product. Densitometric standards are established by printing control targets using the pressplates, inks, pre-press proofs, and paper to be used for printing.

Nonlinear Multiobjective MPC-Based Optimal Operation of a High Consistency Refining System in Papermaking

DOE PAGES

Li, Mingjie; Zhou, Ping; Wang, Hong; ...

2017-09-19

As one of the most important unit in the papermaking industry, the high consistency (HC) refining system is confronted with challenges such as improving pulp quality, energy saving, and emissions reduction in its operation processes. Here in this correspondence, an optimal operation of HC refining system is presented using nonlinear multiobjective model predictive control strategies that aim at set-point tracking objective of pulp quality, economic objective, and specific energy (SE) consumption objective, respectively. First, a set of input and output data at different times are employed to construct the subprocess model of the state process model for the HC refiningmore » system, and then the Wiener-type model can be obtained through combining the mechanism model of Canadian Standard Freeness and the state process model that determines their structures based on Akaike information criterion. Second, the multiobjective optimization strategy that optimizes both the set-point tracking objective of pulp quality and SE consumption is proposed simultaneously, which uses NSGA-II approach to obtain the Pareto optimal set. Furthermore, targeting at the set-point tracking objective of pulp quality, economic objective, and SE consumption objective, the sequential quadratic programming method is utilized to produce the optimal predictive controllers. In conclusion, the simulation results demonstrate that the proposed methods can make the HC refining system provide a better performance of set-point tracking of pulp quality when these predictive controllers are employed. In addition, while the optimal predictive controllers orienting with comprehensive economic objective and SE consumption objective, it has been shown that they have significantly reduced the energy consumption.« less

Nonlinear Multiobjective MPC-Based Optimal Operation of a High Consistency Refining System in Papermaking

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

Li, Mingjie; Zhou, Ping; Wang, Hong

As one of the most important unit in the papermaking industry, the high consistency (HC) refining system is confronted with challenges such as improving pulp quality, energy saving, and emissions reduction in its operation processes. Here in this correspondence, an optimal operation of HC refining system is presented using nonlinear multiobjective model predictive control strategies that aim at set-point tracking objective of pulp quality, economic objective, and specific energy (SE) consumption objective, respectively. First, a set of input and output data at different times are employed to construct the subprocess model of the state process model for the HC refiningmore » system, and then the Wiener-type model can be obtained through combining the mechanism model of Canadian Standard Freeness and the state process model that determines their structures based on Akaike information criterion. Second, the multiobjective optimization strategy that optimizes both the set-point tracking objective of pulp quality and SE consumption is proposed simultaneously, which uses NSGA-II approach to obtain the Pareto optimal set. Furthermore, targeting at the set-point tracking objective of pulp quality, economic objective, and SE consumption objective, the sequential quadratic programming method is utilized to produce the optimal predictive controllers. In conclusion, the simulation results demonstrate that the proposed methods can make the HC refining system provide a better performance of set-point tracking of pulp quality when these predictive controllers are employed. In addition, while the optimal predictive controllers orienting with comprehensive economic objective and SE consumption objective, it has been shown that they have significantly reduced the energy consumption.« less

Perceptual video quality assessment in H.264 video coding standard using objective modeling.

PubMed

Karthikeyan, Ramasamy; Sainarayanan, Gopalakrishnan; Deepa, Subramaniam Nachimuthu

2014-01-01

Since usage of digital video is wide spread nowadays, quality considerations have become essential, and industry demand for video quality measurement is rising. This proposal provides a method of perceptual quality assessment in H.264 standard encoder using objective modeling. For this purpose, quality impairments are calculated and a model is developed to compute the perceptual video quality metric based on no reference method. Because of the shuttle difference between the original video and the encoded video the quality of the encoded picture gets degraded, this quality difference is introduced by the encoding process like Intra and Inter prediction. The proposed model takes into account of the artifacts introduced by these spatial and temporal activities in the hybrid block based coding methods and an objective modeling of these artifacts into subjective quality estimation is proposed. The proposed model calculates the objective quality metric using subjective impairments; blockiness, blur and jerkiness compared to the existing bitrate only calculation defined in the ITU G 1070 model. The accuracy of the proposed perceptual video quality metrics is compared against popular full reference objective methods as defined by VQEG.

Analytical Method Development and Validation for the Simultaneous Estimation of Abacavir and Lamivudine by Reversed-phase High-performance Liquid Chromatography in Bulk and Tablet Dosage Forms.

PubMed

Raees Ahmad, Sufiyan Ahmad; Patil, Lalit; Mohammed Usman, Mohammed Rageeb; Imran, Mohammad; Akhtar, Rashid

2018-01-01

A simple rapid, accurate, precise, and reproducible validated reverse phase high performance liquid chromatography (HPLC) method was developed for the determination of Abacavir (ABAC) and Lamivudine (LAMI) in bulk and tablet dosage forms. The quantification was carried out using Symmetry Premsil C18 (250 mm × 4.6 mm, 5 μm) column run in isocratic way using mobile phase comprising methanol: water (0.05% orthophosphoric acid with pH 3) 83:17 v/v and a detection wavelength of 245 nm and injection volume of 20 μl, with a flow rate of 1 ml/min. In the developed method, the retention times of ABAC and LAMI were found to be 3.5 min and 7.4 min, respectively. The method was validated in terms of linearity, precision, accuracy, limits of detection, limits of quantitation, and robustness in accordance with the International Conference on Harmonization guidelines. The assay of the proposed method was found to be 99% - 101%. The recovery studies were also carried out and mean % recovery was found to be 99% - 101%. The % relative standard deviation from reproducibility was found to be <2%. The proposed method was statistically evaluated and can be applied for routine quality control analysis of ABAC and LAMI in bulk and in tablet dosage form. Attempts were made to develop RP-HPLC method for simultaneous estimation of Abacavir and Lamivudine for the RP-HPLC method. The developed method was validated according to the ICH guidelines. The linearity, precision, range, robustness were within the limits as specified by the ICH guidelines. Hence the method was found to be simple, accurate, precise, economic and reproducible. So the proposed methods can be used for the routine quality control analysis of Abacavir and Lamivudine in bulk drug as well as in formulations. Abbreviations Used: HPLC: High-performance liquid chromatography, UV: Ultraviolet, ICH: International Conference on Harmonization, ABAC: Abacavir, LAMI: Lamivudine, HIV: Human immunodeficiency virus, AIDS: Acquired immunodeficiency syndrome, NRTI: Nucleoside reverse transcriptase inhibitors, ARV: Antiretroviral, RSD: Relative standard deviation, RT: Retention time, SD: Standard deviation.

Determining the status quo of infection prevention and control standards in the hospitals of iran: a case study in 23 hospitals.

PubMed

Shojaee, Jalil; Moosazadeh, Mahmood

2014-02-01

Applying Prevention and Control of Infection (PCI) standards in hospitals reduces probable risks to patients, staff and visitors; it also increases efficiency, and ultimately improves productivity of hospitals. The current study aimed to determine the status quo of international standards of PCI in hospitals located in the north of Iran. This cross-sectional study was conducted in 23 hospitals. Data collection tool was a questionnaire with confirmed validity and reliability. . In this regard, 260 managers, section supervisors and infection control nurses participated in the study according to census basis. SPSS software version 16 was employed to analyze the data through descriptive and analytical statistics. Among the studied hospitals, 18 hospitals were public. Hospitals enjoyed 77.2% of leadership and programming, 80.8% of focus of programs, 67.4% of isolating methods, 88.2% of hand health and protection techniques, 78.8% of improving patient's safety and quality, 90.3% of training personnel, and 78.7% of the average status quo of PCI standards. This study revealed that PCI standards were significantly observed in the studied hospitals and that there were necessary conditions for full deployment of nosocomial infection surveillance.

Standard operating procedure changed pre-hospital critical care anaesthesiologists’ behaviour: a quality control study

PubMed Central

2013-01-01

Introduction The ability of standard operating procedures to improve pre-hospital critical care by changing pre-hospital physician behaviour is uncertain. We report data from a prospective quality control study of the effect on pre-hospital critical care anaesthesiologists’ behaviour of implementing a standard operating procedure for pre-hospital controlled ventilation. Materials and methods Anaesthesiologists from eight pre-hospital critical care teams in the Central Denmark Region prospectively registered pre-hospital advanced airway-management data according to the Utstein-style template. We collected pre-intervention data from February 1st 2011 to January 31st 2012, implemented the standard operating procedure on February 1st 2012 and collected post intervention data from February 1st 2012 until October 31st 2012. We included transported patients of all ages in need of controlled ventilation treated with pre-hospital endotracheal intubation or the insertion of a supraglottic airways device. The objective was to evaluate whether the development and implementation of a standard operating procedure for controlled ventilation during transport could change pre-hospital critical care anaesthesiologists’ behaviour and thereby increase the use of automated ventilators in these patients. Results The implementation of a standard operating procedure increased the overall prevalence of automated ventilator use in transported patients in need of controlled ventilation from 0.40 (0.34-0.47) to 0.74 (0.69-0.80) with a prevalence ratio of 1.85 (1.57-2.19) (p = 0.00). The prevalence of automated ventilator use in transported traumatic brain injury patients in need of controlled ventilation increased from 0.44 (0.26-0.62) to 0.85 (0.62-0.97) with a prevalence ratio of 1.94 (1.26-3.0) (p = 0.0039). The prevalence of automated ventilator use in patients transported after return of spontaneous circulation following pre-hospital cardiac arrest increased from 0.39 (0.26-0.48) to 0.69 (0.58-0.78) with a prevalence ratio of 1.79 (1.36-2.35) (p = 0.00). Conclusion We have shown that the implementation of a standard operating procedure for pre-hospital controlled ventilation can significantly change pre-hospital critical care anaesthesiologists’ behaviour. PMID:24308781

Evaluating the quality of a cell counting measurement process via a dilution series experimental design.

PubMed

Sarkar, Sumona; Lund, Steven P; Vyzasatya, Ravi; Vanguri, Padmavathy; Elliott, John T; Plant, Anne L; Lin-Gibson, Sheng

2017-12-01

Cell counting measurements are critical in the research, development and manufacturing of cell-based products, yet determining cell quantity with accuracy and precision remains a challenge. Validating and evaluating a cell counting measurement process can be difficult because of the lack of appropriate reference material. Here we describe an experimental design and statistical analysis approach to evaluate the quality of a cell counting measurement process in the absence of appropriate reference materials or reference methods. The experimental design is based on a dilution series study with replicate samples and observations as well as measurement process controls. The statistical analysis evaluates the precision and proportionality of the cell counting measurement process and can be used to compare the quality of two or more counting methods. As an illustration of this approach, cell counting measurement processes (automated and manual methods) were compared for a human mesenchymal stromal cell (hMSC) preparation. For the hMSC preparation investigated, results indicated that the automated method performed better than the manual counting methods in terms of precision and proportionality. By conducting well controlled dilution series experimental designs coupled with appropriate statistical analysis, quantitative indicators of repeatability and proportionality can be calculated to provide an assessment of cell counting measurement quality. This approach does not rely on the use of a reference material or comparison to "gold standard" methods known to have limited assurance of accuracy and precision. The approach presented here may help the selection, optimization, and/or validation of a cell counting measurement process. Published by Elsevier Inc.

7 CFR 51.1179 - Method of juice extraction.

Code of Federal Regulations, 2010 CFR

2010-01-01

... STANDARDS) United States Standards for Grades of Florida Oranges and Tangelos Standards for Internal Quality... 7 Agriculture 2 2010-01-01 2010-01-01 false Method of juice extraction. 51.1179 Section 51.1179 Agriculture Regulations of the Department of Agriculture AGRICULTURAL MARKETING SERVICE (Standards...

Critical levels as applied to ozone for North American forests

Treesearch

Robert C. Musselman

2006-01-01

The United States and Canada have used concentration-based parameters for air quality standards for ozone effects on forests in North America. The European critical levels method for air quality standards uses an exposure-based parameter, a cumulative ozone concentration index with a threshold cutoff value. The critical levels method has not been used in North America...

Academic Quality Control: The Case of College Programs on Military Bases.

ERIC Educational Resources Information Center

Bailey, Stephen K.

The quality of college programs at 13 U.S. military bases and the activities of various agencies for maintaining quality control were evaluated. Based on site visits to military bases in the continental United States and Hawaii in 1978, some academic programs appeared to have few standards and practices that promote quality. It is claimed that…

77 FR 58352 - Approval and Promulgation of Implementation Plans; State of Missouri

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-20

... the state of Missouri on September 21, 2010. This revision proposes to amend the ambient air quality standards table to reflect revised National Ambient Air Quality Standards (NAAQS), update reference methods associated with the revised NAAQS, and update the breakpoint values for the Air Quality Index. These...

Multiple fingerprinting analyses in quality control of Cassiae Semen polysaccharides.

PubMed

Cheng, Jing; He, Siyu; Wan, Qiang; Jing, Pu

2018-03-01

Quality control issue overshadows potential health benefits of Cassiae Semen due to the analytic limitations. In this study, multiple-fingerprint analysis integrated with several chemometrics was performed to assess the polysaccharide quality of Cassiae Semen harvested from different locations. FT-IR, HPLC, and GC fingerprints of polysaccharide extracts from the authentic source were established as standard profiles, applying to assess the quality of foreign sources. Analyses of FT-IR fingerprints of polysaccharide extracts using either Pearson correlation analysis or principal component analysis (PCA), or HPLC fingerprints of partially hydrolyzed polysaccharides with PCA, distinguished the foreign sources from the authentic source. However, HPLC or GC fingerprints of completely hydrolyzed polysaccharides couldn't identify all foreign sources and the methodology using GC is quite limited in determining the monosaccharide composition. This indicates that FT-IR/HPLC fingerprints of non/partially-hydrolyzed polysaccharides, respectively, accompanied by multiple chemometrics methods, might be potentially applied in detecting and differentiating sources of Cassiae Semen. Copyright © 2018 Elsevier B.V. All rights reserved.

Standard procedures and quality-control practices for the U.S. Geological Survey National Field Quality Assurance Program from 1982 through 1993

USGS Publications Warehouse

Stanley, D.L.

1995-01-01

The U.S. Geological Survey operates the National Field Quality Assurance Program to provide quality- assurance reference samples to field personnel who make water-quality field measurements. The program monitors the accuracy and precision of pH, specific conductance, and alkalinity field measurements. This report documents the operational procedures and quality-control techniques used in operating the quality-assurance program.

30 CFR 28.33 - Quality control test methods, equipment, and records; review by MSHA; revocation of approval.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Quality control test methods, equipment, and... USE WITH DIRECT CURRENT IN PROVIDING SHORT-CIRCUIT PROTECTION FOR TRAILING CABLES IN COAL MINES Quality Control § 28.33 Quality control test methods, equipment, and records; review by MSHA; revocation...

30 CFR 28.33 - Quality control test methods, equipment, and records; review by MSHA; revocation of approval.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Quality control test methods, equipment, and... USE WITH DIRECT CURRENT IN PROVIDING SHORT-CIRCUIT PROTECTION FOR TRAILING CABLES IN COAL MINES Quality Control § 28.33 Quality control test methods, equipment, and records; review by MSHA; revocation...

30 CFR 28.33 - Quality control test methods, equipment, and records; review by MSHA; revocation of approval.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Quality control test methods, equipment, and... USE WITH DIRECT CURRENT IN PROVIDING SHORT-CIRCUIT PROTECTION FOR TRAILING CABLES IN COAL MINES Quality Control § 28.33 Quality control test methods, equipment, and records; review by MSHA; revocation...

30 CFR 28.33 - Quality control test methods, equipment, and records; review by MSHA; revocation of approval.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Quality control test methods, equipment, and... USE WITH DIRECT CURRENT IN PROVIDING SHORT-CIRCUIT PROTECTION FOR TRAILING CABLES IN COAL MINES Quality Control § 28.33 Quality control test methods, equipment, and records; review by MSHA; revocation...

30 CFR 28.33 - Quality control test methods, equipment, and records; review by MSHA; revocation of approval.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Quality control test methods, equipment, and... USE WITH DIRECT CURRENT IN PROVIDING SHORT-CIRCUIT PROTECTION FOR TRAILING CABLES IN COAL MINES Quality Control § 28.33 Quality control test methods, equipment, and records; review by MSHA; revocation...

[The technological innovation strategy for quality control of Chinese medicine based on Big Data].

PubMed

Li, Zhen-hao; Qian, Zhong-zhi; Cheng, Yi-yu

2015-09-01

The evolution of the quality control concepts of medical products within the global context and the development of the quality control technology of Chinese medicine are briefly described. Aimed at the bottlenecks in the regulation and quality control of Chinese medicine, using Big Data technology to address the significant challenges in Chinese medicine industry is proposed. For quality standard refinements and internationalization of Chinese medicine, a technological innovation strategy encompassing its methodology, and the R&D direction of the subsequent core technology are also presented.

Impact of National Ambient Air Quality Standards Nonattainment Designations on Particulate Pollution and Health.

PubMed

Zigler, Corwin M; Choirat, Christine; Dominici, Francesca

2018-03-01

Despite dramatic air quality improvement in the United States over the past decades, recent years have brought renewed scrutiny and uncertainty surrounding the effectiveness of specific regulatory programs for continuing to improve air quality and public health outcomes. We employ causal inference methods and a spatial hierarchical regression model to characterize the extent to which a designation of "nonattainment" with the 1997 National Ambient Air Quality Standard for ambient fine particulate matter (PM2.5) in 2005 causally affected ambient PM2.5 and health outcomes among over 10 million Medicare beneficiaries in the Eastern United States in 2009-2012. We found that, on average across all retained study locations, reductions in ambient PM2.5 and Medicare health outcomes could not be conclusively attributed to the nonattainment designations against the backdrop of other regional strategies that impacted the entire Eastern United States. A more targeted principal stratification analysis indicates substantial health impacts of the nonattainment designations among the subset of areas where the designations are estimated to have actually reduced ambient PM2.5 beyond levels achieved by regional measures, with noteworthy reductions in all-cause mortality, chronic obstructive pulmonary disorder, heart failure, ischemic heart disease, and respiratory tract infections. These findings provide targeted evidence of the effectiveness of local control measures after nonattainment designations for the 1997 PM2.5 air quality standard.

Methods proposed to achieve air quality standards for mobile sources and technology surveillance.

PubMed Central

Piver, W T

1975-01-01

The methods proposed to meet the 1975 Standards of the Clean Air Act for mobile sources are alternative antiknocks, exhaust emission control devices, and alternative engine designs. Technology surveillance analysis applied to this situation is an attempt to anticipate potential public and environmental health problems from these methods, before they happen. Components of this analysis are exhaust emission characterization, environmental transport and transformation, levels of public and environmental exposure, and the influence of economics on the selection of alternative methods. The purpose of this presentation is to show trends as a result of the interaction of these different components. In no manner can these trends be interpreted explicitly as to what will really happen. Such an analysis is necessary so that public and environmental health officials have the opportunity to act on potential problems before they become manifest. PMID:50944

78 FR 45112 - Approval and Promulgation of Air Quality Implementation Plans; Missouri; Reasonably Available...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-26

... Promulgation of Air Quality Implementation Plans; Missouri; Reasonably Available Control Technology (RACT) for the 8-Hour Ozone National Ambient Air Quality Standard (NAAQS) AGENCY: Environmental Protection Agency... revision is to amend Missouri's regulation for the Control of Volatile Organic Compounds (VOC) and meet the...

77 FR 3144 - Approval and Promulgation of Air Quality Implementation Plans; Missouri; Reasonably Available...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-23

... Promulgation of Air Quality Implementation Plans; Missouri; Reasonably Available Control Technology (RACT) for the 8-Hour Ozone National Ambient Air Quality Standard (NAAQS) AGENCY: Environmental Protection Agency... these revisions because they enhance the Missouri SIP by improving VOC emission controls in Missouri...

Implementation and results of an integrated data quality assurance protocol in a randomized controlled trial in Uttar Pradesh, India.

PubMed

Gass, Jonathon D; Misra, Anamika; Yadav, Mahendra Nath Singh; Sana, Fatima; Singh, Chetna; Mankar, Anup; Neal, Brandon J; Fisher-Bowman, Jennifer; Maisonneuve, Jenny; Delaney, Megan Marx; Kumar, Krishan; Singh, Vinay Pratap; Sharma, Narender; Gawande, Atul; Semrau, Katherine; Hirschhorn, Lisa R

2017-09-07

There are few published standards or methodological guidelines for integrating Data Quality Assurance (DQA) protocols into large-scale health systems research trials, especially in resource-limited settings. The BetterBirth Trial is a matched-pair, cluster-randomized controlled trial (RCT) of the BetterBirth Program, which seeks to improve quality of facility-based deliveries and reduce 7-day maternal and neonatal mortality and maternal morbidity in Uttar Pradesh, India. In the trial, over 6300 deliveries were observed and over 153,000 mother-baby pairs across 120 study sites were followed to assess health outcomes. We designed and implemented a robust and integrated DQA system to sustain high-quality data throughout the trial. We designed the Data Quality Monitoring and Improvement System (DQMIS) to reinforce six dimensions of data quality: accuracy, reliability, timeliness, completeness, precision, and integrity. The DQMIS was comprised of five functional components: 1) a monitoring and evaluation team to support the system; 2) a DQA protocol, including data collection audits and targets, rapid data feedback, and supportive supervision; 3) training; 4) standard operating procedures for data collection; and 5) an electronic data collection and reporting system. Routine audits by supervisors included double data entry, simultaneous delivery observations, and review of recorded calls to patients. Data feedback reports identified errors automatically, facilitating supportive supervision through a continuous quality improvement model. The five functional components of the DQMIS successfully reinforced data reliability, timeliness, completeness, precision, and integrity. The DQMIS also resulted in 98.33% accuracy across all data collection activities in the trial. All data collection activities demonstrated improvement in accuracy throughout implementation. Data collectors demonstrated a statistically significant (p = 0.0004) increase in accuracy throughout consecutive audits. The DQMIS was successful, despite an increase from 20 to 130 data collectors. In the absence of widely disseminated data quality methods and standards for large RCT interventions in limited-resource settings, we developed an integrated DQA system, combining auditing, rapid data feedback, and supportive supervision, which ensured high-quality data and could serve as a model for future health systems research trials. Future efforts should focus on standardization of DQA processes for health systems research. ClinicalTrials.gov identifier, NCT02148952 . Registered on 13 February 2014.

[Establishment of biological assess for quality control of Fuzi based on determination of premature ventricular contractions in rats].

PubMed

Zhao, Zhi-Hao; Zhang, Ding-Kun; Wu, Ming-Quan; Li, Chun-Yu; Cao, Li-Juan; Zhang, Ping; Liu, Cui-Zhe; Wang, Jia-Bo; Xiao, Xiao-He

2016-10-01

Aconiti Lateralis Radix (Fuzi) is a toxic traditional Chinese medicine with definite efficacy. In order to improve the quality control of its different prepared products and ensure the security in clinic, it is significant to establish a method of quality evaluation related to clinic adverse effects. Aiming at the important biological marker of early cardiac toxicity reaction, there was no method to detect it. In this manuscript, a novel approach for measuring the minimal toxic dose (MTD) of premature ventricular contractions (PVC) poisoning of rats was established. Then, the determination methodology and conditions were optimized to meet the needs of the quality and biological assessment, including animal sex, weight, stability of standards and test solutions. Using this method, the MTD value of different Fuzi products were determined, such as Heishunpian, Baifupian, Zhengfupian, Baofupian, and Paotianxiong. The results showed that the MTD of Fuzi was significantly decreased after detoxification processed (P<0.05) and the MTD of Heishunpian, Zhengfupian, Baofupian and Baifupian was as much as 15.76, 22.36, 19.65 and 20.97 times to that of unprocessed Shengfuzi. In addition, Paotianxiong could not induce PVC in rats, which indicated that Paotianxiong was nontoxic and safe.This method could appropriately reflects the cardiotoxity of Fuzi and its prepared samples. Together with the chemical composition analysis, the contents of diester alkaloids were explored including aconitine, mesaconitine and hypaconitine as well as monoester alkaloids in Fuzi and its prepared products were significantly associated with PVC. Furthermore, there may be some components undetermined facilitating arrhythmia to be worth exploring. This research provides an overall and comprehensive approach to diagnose early clinical cardiotoxity and control the quality of Fuzi, which could not only be a complementary solution for the chemical evaluation, but a new method to ensure its efficacy and security of clinical application. Copyright© by the Chinese Pharmaceutical Association.

Qualitative and quantitative analyses of flavonoids in Spirodela polyrrhiza by high-performance liquid chromatography coupled with mass spectrometry.

PubMed

Qiao, Xue; He, Wen-ni; Xiang, Cheng; Han, Jian; Wu, Li-jun; Guo, De-an; Ye, Min

2011-01-01

Spirodela polyrrhiza (L.) Schleid. is a traditional Chinese herbal medicine for the treatment of influenza. Despite its wide use in Chinese medicine, no report on quality control of this herb is available so far. To establish qualitative and quantitative analytical methods by high-performance liquid chromatography (HPLC) coupled with mass spectrometry (MS) for the quality control of S. polyrrhiza. The methanol extract of S. polyrrhiza was analysed by HPLC/ESI-MS(n). Flavonoids were identified by comparing with reference standards or according to their MS(n) (n = 2-4) fragmentation behaviours. Based on LC/MS data, a standardised HPLC fingerprint was established by analysing 15 batches of commercial herbal samples. Furthermore, quantitative analysis was conducted by determining five major flavonoids, namely luteolin 8-C-glucoside, apigenin 8-C-glucoside, luteolin 7-O-glucoside, apigenin 7-O-glucoside and luteolin. A total of 18 flavonoids were identified by LC/MS, and 14 of them were reported from this herb for the first time. The HPLC fingerprints contained 10 common peaks, and could differentiate good quality batches from counterfeits. The total contents of five major flavonoids in S. polyrrhiza varied significantly from 4.28 to 19.87 mg/g. Qualitative LC/MS and quantitative HPLC analytical methods were established for the comprehensive quality control of S. polyrrhiza. Copyright © 2011 John Wiley & Sons, Ltd.

Quality control and in vitro antioxidant potential of Coriandrum sativum Linn.

PubMed Central

Singh, Mhaveer; Tamboli, E. T.; Kamal, Y. T.; Ahmad, Wasim; Ansari, S. H.; Ahmad, Sayeed

2015-01-01

Background: Coriandrum sativum Linn., commonly known as coriander, is a well-known spice and drug in India. It has various health-related benefits and used in various Unani formulations. In this present study, quality assessment of coriander fruits was carried out by studying anatomical characters, physicochemical tests, and chemoprofiling using high performance thin layer chromatography (HPTLC) and gas chromatography-mass spectroscopy (GC-MS) along with in vitro antioxidant potential. Materials and Methods: Standardization was carried out as per the pharmacopeial guidelines. Estimation of heavy metals, pesticides, and aflatoxins was carried out to ascertain the presence of any contaminant in the sample. Chemoprofiling was achieved by thin layer chromatography (TLC) by optimizing the mobile phase for different extracts. The most of the pharmacological activities of coriander are based on volatile oil constituents. Hence, GC-MS profiling was also carried out using hexane-soluble fraction of hydro-alcoholic extract. The total phenolic contents and in vitro antioxidant efficacy were determined using previously established methods. Results: The quality control and anatomical studies were very valuable for the identification whereas good antioxidant potential was observed when compared to ascorbic acid. The drug was found free of contaminant when analyzed for pesticides and aflatoxins whereas heavy metals were found under reported limits. Conclusion: The work embodied in this present research can be utilized for the identification and the quality control of the coriander fruit. PMID:26681883

Evaluation of the quality of sandalwood essential oils by gas chromatography-mass spectrometry.

PubMed

Howes, Melanie-Jayne R; Simmonds, Monique S J; Kite, Geoffrey C

2004-03-05

Trade and historic oils from 'sandalwoods', labelled as Amyris balsamifera, Eremophila mitchelli, Fusanus acuminatus (= Santalum acuminatum), Santalum album, S. austrocaledonicum, S. latifolium, S. spicatum and S. yasi, were assessed using gas chromatography-mass spectrometry (GC-MS). Using GC-MS, none of the oils assessed complied with the internationally recognised standard of a 90% santalol content, and only about half of the trade sandalwood oils met with recent International Organisation for Standardisation standards. The majority of trade oils, reportedly from S. album, contained approximately 50-70% santalols (Z-alpha and Z-beta). Thus, the internationally recognised specification (90% santalols) for S. album requires re-evaluation by more efficient analysis methods. In view of the issues associated with the quality of sandalwood oils being traded, specifications of > or = 43% Z-alpha-santalol and > or = 18% Z-beta-santalol for S. album oil estimated by GC-MS are suggested. GC-MS are recommended as it assists with authentication and quality control issues associated with sandalwood oils.

40 CFR 52.1870 - Identification of plan.

Code of Federal Regulations, 2013 CFR

2013-07-01

...) Title of plan: “Implementation Plan for the Control of Suspended Particulates, Sulfur Dioxide, Carbon... 20, 1972, by the Ohio Air Pollution Control Board. (2) State provisions for making emissions data... Quality Control Region” and the “Implementation Plan to Achieve Ambient Air Quality Standard for...

75 FR 60013 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Control of Volatile...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-29

... Promulgation of Air Quality Implementation Plans; Maryland; Control of Volatile Organic Compounds Emissions... Maryland's Volatile Organic Compounds from Specific Processes Regulation. Maryland has adopted standards... (RACT) requirements for sources of volatile organic compounds (VOCs) covered by control techniques...

Low cost composite manufacturing utilizing intelligent pultrusion and resin transfer molding (IPRTM)

NASA Astrophysics Data System (ADS)

Bradley, James E.; Wysocki, Tadeusz S., Jr.

1993-02-01

This article describes an innovative method for the economical manufacturing of large, intricately-shaped tubular composite parts. Proprietary intelligent process control techniques are combined with standard pultrusion and RTM methodologies to provide high part throughput, performance, and quality while substantially reducing scrap, rework costs, and labor requirements. On-line process monitoring and control is achieved through a smart tooling interface consisting of modular zone tiles installed on part-specific die assemblies. Real-time archiving of process run parameters provides enhanced SPC and SQC capabilities.

Genetic mouse embryo assay: improving performance and quality testing for assisted reproductive technology (ART) with a functional bioassay.

PubMed

Gilbert, Rebecca S; Nunez, Brandy; Sakurai, Kumi; Fielder, Thomas; Ni, Hsiao-Tzu

2016-03-24

Growing concerns about safety of ART on human gametes, embryos, clinical outcomes and long-term health of offspring require improved methods of risk assessment to provide functionally relevant assays for quality control testing and pre-clinical studies prior to clinical implementation. The one-cell mouse embryo assay (MEA) is the most widely used for development and quality testing of human ART products; however, concerns exist due to the insensitivity/variability of this bioassay which lacks standardization and involves subjective analysis by morphology alone rather than functional analysis of the developing embryos. We hypothesized that improvements to MEA by the use of functional molecular biomarkers could enhance sensitivity and improve detection of suboptimal materials/conditions. Fresh one-cell transgenic mouse embryos with green fluorescent protein (GFP) expression driven by Pou6f1 or Cdx2 control elements were harvested and cultured to blastocysts in varied test and control conditions to compare assessment by standard morphology alone versus the added dynamic expression of GFP for screening and selection of critical raw materials and detection of suboptimal culture conditions. Transgenic mouse embryos expressing functionally relevant biomarkers of normal early embryo development can be used to monitor the developmental impact of culture conditions. This novel approach provides a superior MEA that is more meaningful and sensitive for detection of embryotoxicity than morphological assessment alone.

Secured web-based video repository for multicenter studies

PubMed Central

Yan, Ling; Hicks, Matt; Winslow, Korey; Comella, Cynthia; Ludlow, Christy; Jinnah, H. A; Rosen, Ami R; Wright, Laura; Galpern, Wendy R; Perlmutter, Joel S

2015-01-01

Background We developed a novel secured web-based dystonia video repository for the Dystonia Coalition, part of the Rare Disease Clinical Research network funded by the Office of Rare Diseases Research and the National Institute of Neurological Disorders and Stroke. A critical component of phenotypic data collection for all projects of the Dystonia Coalition includes a standardized video of each participant. We now describe our method for collecting, serving and securing these videos that is widely applicable to other studies. Methods Each recruiting site uploads standardized videos to a centralized secured server for processing to permit website posting. The streaming technology used to view the videos from the website does not allow downloading of video files. With appropriate institutional review board approval and agreement with the hosting institution, users can search and view selected videos on the website using customizable, permissions-based access that maintains security yet facilitates research and quality control. Results This approach provides a convenient platform for researchers across institutions to evaluate and analyze shared video data. We have applied this methodology for quality control, confirmation of diagnoses, validation of rating scales, and implementation of new research projects. Conclusions We believe our system can be a model for similar projects that require access to common video resources. PMID:25630890

Introduction of software tools for epidemiological surveillance in infection control in Colombia

PubMed Central

Motoa, Gabriel; Vallejo, Marta; Blanco, Víctor M; Correa, Adriana; de la Cadena, Elsa; Villegas, María Virginia

2015-01-01

Introduction: Healthcare-Associated Infections (HAI) are a challenge for patient safety in the hospitals. Infection control committees (ICC) should follow CDC definitions when monitoring HAI. The handmade method of epidemiological surveillance (ES) may affect the sensitivity and specificity of the monitoring system, while electronic surveillance can improve the performance, quality and traceability of recorded information. Objective: To assess the implementation of a strategy for electronic surveillance of HAI, Bacterial Resistance and Antimicrobial Consumption by the ICC of 23 high-complexity clinics and hospitals in Colombia, during the period 2012-2013. Methods: An observational study evaluating the introduction of electronic tools in the ICC was performed; we evaluated the structure and operation of the ICC, the degree of incorporation of the software HAI Solutions and the adherence to record the required information. Results: Thirty-eight percent of hospitals (8/23) had active surveillance strategies with standard criteria of the CDC, and 87% of institutions adhered to the module of identification of cases using the HAI Solutions software. In contrast, compliance with the diligence of the risk factors for device-associated HAIs was 33%. Conclusions: The introduction of ES could achieve greater adherence to a model of active surveillance, standardized and prospective, helping to improve the validity and quality of the recorded information. PMID:26309340

[Preparation and certification of mussel reference material for organochlorine pesticides and polychlorinated biphenyls using isotope dilution-high resolution mass spectrometry].

PubMed

Lu, Xianbo; Chen, Jiping; Wang, Shuqiu; Zou, Lili; Tian, Yuzeng; Ni, Yuwen; Su, Fan

2012-09-01

A method for the preparation and certification of the reference material of organochlorine pesticides (OCPs) and polychlorinated biphenyls (PCBs) in mussel tissue is described. The mussel tissue from Dalian Bay was frozen-dried, comminuted, sieved, homogenized, packaged, and sterilized by 60Co radiation sterilization in turn. The certified values for 18 OCPs and 16 PCBs were determined by high resolution gas chromatography/high resolution mass spectrometry (HRGC/HRMS) using isotope dilution and internal standard quantitation techniques. The certified values were validated and given based on seven accredited laboratories, and these values are traceable to the SI (international system of units) through gravimetrically prepared standards of established purity and measurement intercomparisons. The certified values of PCBs and OCPs in mussel span 4 orders of magnitude with a relative uncertainty of about 10%. This material is a natural biological material with confirmed good homogeneity and stability, and it was approved as the grade "primary reference material" (GBW10069) in June 2012 in China. This reference material provided necessary quality control products for our country to implement the Stockholm Treaty on the monitoring of persistent organic pollutants (POPs). The material is intended to be used for the method validation and quality control in the determination of OCPs and PCBs in biota samples.

DEVELOPMENT OF INTERNATIONAL STANDARDS FOR AIR QUALITY MONITORING AND CONTROL

EPA Science Inventory

This report presents a description of the activities and accomplishments of the American Society for Testing and Materials' U. S. Technical Advisory Group (TAG) to the International Standards Organization's Technical Committee 146 on Air Quality. The purpose of the TAG is to re...

Quality Assurance through ISO 9000.

ERIC Educational Resources Information Center

Zuckerman, Amy

2000-01-01

Created in 1987 by the International Organization for Standardization, in Geneva, Switzerland, ISO 9000 is attempting to develop a world standard to help companies and other institutions measure and monitor their quality-control efforts. This article describes four school districts' successful efforts to secure ISO 9000 certification. (MLH)

An optimized high-performance liquid chromatography (HPLC) method for benzoylmesaconine determination in Radix Aconiti Lateralis Preparata (Fuzi, aconite roots) and its products

PubMed Central

Xie, Ying; Zhou, Hua; Wong, Yuen Fan; Liu, Zhongqiu; Xu, Hongxi; Jiang, Zhihong; Liu, Liang

2008-01-01

Background Benzoylmesaconine (BMA) is the main Aconitum alkaloid in Radix Aconiti Lateralis Preparata (Fuzi, aconite roots) with potent pharmacological activities, such as analgesia and anti-inflammation. The present study developed a simple and reliable method using BMA as a marker compound for the quality control of processed aconite roots and their products. Methods After extraction, a high-performance liquid chromatography (HPLC) determination of BMA was conducted on a RP-C18 column by gradient elution with acetonitrile and aqueous phase, containing 0.1% phosphoric acid adjusted with triethylamine to pH 3.0. Results A distinct peak profile was obtained and separation of BMA was achieved. Method validation showed that the relative standard deviations (RSDs) of the precision of BMA in all intra-day and inter-day assays were less than 1.36%, and that the average recovery rate was 96.95%. Quantitative analysis of BMA showed that the content of BMA varied significantly in processed aconite roots and their products. Conclusion This HPLC method using BMA as a marker compound is applicable to the quality control of processed aconite roots and their products. PMID:18513409

Does theatre improve the quality of life of people with dementia?

PubMed

van Dijk, A Marijke; van Weert, Julia C M; Dröes, Rose-Marie

2012-03-01

A new communication method, the "Veder method", has recently been developed. Caregivers are trained to apply this method in a group activity ("living-room theatre activity") for people with dementia in which theatrical stimuli are used in combination with proven emotion-oriented care methods. The aim of this exploratory study was to evaluate the added value of the Veder method group activity compared to a regular reminiscence group activity and to investigate whether professional carers can achieve the same effects with the Veder method as professional actors. A quasi-experimental three-group design was used. Experimental group 1 (E1; n = 65) joined a living-room theatre activity offered by trained professional caregivers. Experimental group 2 (E2; n = 31) joined a living-room theatre activity offered by professional actors. The control group (n = 55) received a usual reminiscence group activity. Behavior, mood and aspects of quality of life were measured using standardized observation scales at three points in time: (T1) pretest; (T2) during the intervention and; (T3) post-test, two hours after the intervention. During the intervention, significant differences were found in favor of the group that was offered a living-room theatre activity by actors (E2) on different aspects of behavior, mood and quality of life. At post-test, people in E2 were more alert compared to the control group. Moreover, they recalled more memories and showed less socially isolated behavior compared to the control group. This exploratory study shows that the Veder method has some clear positive effects on behavior and mood of people with dementia when applied by professional actors.

Field Performance of High-Quality and Standard Northern Red Oak Seedlings in Tennessee

Treesearch

David S. Buckley

2002-01-01

First-year performance of high-quality (HQ), high-quality cull (HQC) and standard (ST) northern red oak (Quercus rubra) nursery seedlings was compared in a study established in a recent clearcut in mid-March, 2000. Objectives were to test effects of 1) seedling type, 2) planting treatment, and 3) control of competitors on the growth, browsing, and...

Methods for Environments and Contaminants: Criteria Air Pollutants

EPA Pesticide Factsheets

EPA’s Office of Air Quality Planning and Standards (OAQPS) has set primary (health-based) National Ambient Air Quality Standards (NAAQS) for six common air pollutants, often referred to as criteria air pollutants (or simply criteria pollutants).

Total Quality Management in the United States Army Corps of Engineers

DTIC Science & Technology

1993-05-01

Office. Telephone interview with author, 20 November 1992. Ishikawa , Kaoru (1985). What is Total Quality Control? The Japanese Way. Prentice-Hall, Inc...Organizations ..... 55 Table 13. Ishikawa PDCA Cycle .......................................................... 68 Table 14. TQM Training M atrix...Standards 1008 ( Ishikawa 1985). The Japanese were aware of both the American and British work with standards. The standards were studied by

Authenticity analyses of Rhizoma Paridis using barcoding coupled with high resolution melting (Bar-HRM) analysis to control its quality for medicinal plant product.

PubMed

Duan, Bao-Zhong; Wang, Ya-Ping; Fang, Hai-Lan; Xiong, Chao; Li, Xi-Wen; Wang, Ping; Chen, Shi-Lin

2018-01-01

Rhizoma Paridis (Chonglou) is a commonly used and precious traditional Chinese medicine. Paris polyphylla Smith var. yunnanensis (Franch.) Hand. -Mazz. and Paris polyphylla Smith var . chinensis (Franch.) Hara are the two main sources of Chonglou under the monograph of Rhizoma Paridis in Chinese Pharmacopoeia. In the local marketplace, however, this medicine is prone to be accidentally contaminated, deliberately substituted or admixed with other species that are similar to Rhizoma Paridis in shape and color. Consequently, these adulterations might compromise quality control and result in considerable health concerns for consumers. This study aims to develop a rapid and sensitive method for accurate identification of Rhizoma Paridis and its common adulterants. DNA barcoding coupled with high resolution melting analysis was applied in this research to distinguish Rhizoma Paridis from its adulteration. The internal transcribed spacer 2 (ITS2) barcode was selected for HRM analysis to produce standard melting profile of the selected species. DNA of the tested herbal medicines was isolated and their melting profiles were generated and compared with the standard melting profile of P. polyphylla var. chinensis . The results indicate that the ITS2 molecular regions coupled with HRM analysis can effectively differentiate nine herbal species, including two authentic origins of Chonglou and their seven common adulterants. Ten herbal medicines labeled "Chonglou" obtained from a local market were collected and identified with our methods, and their sequence information was analyzed to validate the accuracy of HRM analysis. DNA barcoding coupled with HRM analysis is a accurate, reliable, rapid, cost-effective and robust tool, which could contribute to the quality control of Rhizoma Paridis in the supply chain of the natural health product industry (NHP).

An empirical evaluation of software quality assurance practices and challenges in a developing country: a comparison of Nigeria and Turkey.

PubMed

Sowunmi, Olaperi Yeside; Misra, Sanjay; Fernandez-Sanz, Luis; Crawford, Broderick; Soto, Ricardo

2016-01-01

The importance of quality assurance in the software development process cannot be overemphasized because its adoption results in high reliability and easy maintenance of the software system and other software products. Software quality assurance includes different activities such as quality control, quality management, quality standards, quality planning, process standardization and improvement amongst others. The aim of this work is to further investigate the software quality assurance practices of practitioners in Nigeria. While our previous work covered areas on quality planning, adherence to standardized processes and the inherent challenges, this work has been extended to include quality control, software process improvement and international quality standard organization membership. It also makes comparison based on a similar study carried out in Turkey. The goal is to generate more robust findings that can properly support decision making by the software community. The qualitative research approach, specifically, the use of questionnaire research instruments was applied to acquire data from software practitioners. In addition to the previous results, it was observed that quality assurance practices are quite neglected and this can be the cause of low patronage. Moreover, software practitioners are neither aware of international standards organizations or the required process improvement techniques; as such their claimed standards are not aligned to those of accredited bodies, and are only limited to their local experience and knowledge, which makes it questionable. The comparison with Turkey also yielded similar findings, making the results typical of developing countries. The research instrument used was tested for internal consistency using the Cronbach's alpha, and it was proved reliable. For the software industry in developing countries to grow strong and be a viable source of external revenue, software assurance practices have to be taken seriously because its effect is evident in the final product. Moreover, quality frameworks and tools which require minimum time and cost are highly needed in these countries.

[Quality control of Guci tablets using UPLC-ELSD fingerprint analysis coupled with chemometrics].

PubMed

Wang, Ya-Dan; Dai, Zhong; Sun, Cai-Lin; Wu, Xian-Fu; Ma, Shuang-Cheng

2018-03-01

Ultra-performance liquid chromatography-evaporative light scattering detection (UPLC-ELSD) fingerprint analysis method was established for quality control of Guci tablets. Chromatographic separation was performed on Waters Acquity UPLC BEH C₁₈ column (2.1 mm×100 mm, 1.7 μm) at 30 °C of column temperature. Acetonitrile-0.1% formic acid solution was adopted as mobile phase for gradient elution. The flow rate was set at 0.3 mL·min⁻¹, and the injection volume was 3 μL. Detection was carried out on an ELSD with a nitrogen pressure of 0.28 MPa, drift tube temperature of 60 °C, and gain of 400. A total of 39 batches of samples produced by six manufacturers were measured by using the above method and the data were analyzed by ChemPattern software. The peak present in more than 75% of the samples was defined as a common peak, and 30 common peaks were determined. Among them, 19 peaks were identified by rapid resolution liquid chromatography/tandem mass spectrometry (RRLC-MS/MS) method, 16 of which were confirmed by reference substances. The similarity of the tested samples was 0.47-0.98, suggesting that the quality of the samples from different manufacturers varied greatly. Furthermore, principal component analysis (PCA) and hierarchical analysis (HCA) were performed to clarify the main different components in samples. The results indicated that there might be some feeding problems about Paeoniae Radix Alba, Notoginseng Radix et Rhizoma, and Clematidis Radix et Rhizoma in a few manufacturers. This study provided some evidences for the overall quality control of Guci tablets, as well as its quality standard improvements. Copyright© by the Chinese Pharmaceutical Association.

Assessing inter-laboratory comparability and limits of determination for the analysis of cyclic volatile methyl siloxanes in whole Rainbow Trout (Oncorhynchus mykiss).

PubMed

McGoldrick, Daryl J; Durham, Jeremy; Leknes, Henriette; Kierkegaard, Amelie; Gerhards, Reinhard; Powell, David E; McLachlan, Michael S

2011-11-01

Cyclic volatile methyl siloxanes (cVMS) are high volume production chemicals used in a wide range of industrial and consumer products. Three cVMS compounds (D4, D5, and D6) have and are undergoing environmental risk evaluations in several countries and have been proposed for legal regulation in Canada. As interest in monitoring concentrations of these chemicals in the environment increase, there is a need to evaluate the analytical procedures for cVMS in biological matrices in order to assess the quality of data produced. The purpose of this study was to determine laboratory testing performance for measuring residues of D4, D5, and D6 in a standard set of fish homogenate samples and to estimate limits of determination for each substance. The samples sent to each laboratory consisted of homogenized whole body tissues of hatchery raised rainbow trout which were fed food fortified with D4, D5, and D6 (dosed) and trout that were fed standard food rations (control). The participants analyzed each sample using their analytical method of choice using their own standards and procedures for quantification and quality control. With a few exceptions, participating laboratories generated comparable results for D4, D5, and D6 in both the dosed and control samples having z-scores between 2 and -2. Method detection limits for the whole fish matrix were on average 2.4 ng g(-1) ww for D4, 2.3 ng g(-1) ww for D5, and 1.8 ng g(-1) ww for D6. Crown Copyright © 2011. Published by Elsevier Ltd. All rights reserved.

RAPIDLY MEASURED INDICATORS OF RECREATIONAL WATER QUALITY ARE PREDICTIVE OF SWIMMING ASSOCIATED GASTROINTESTINAL ILLNESS

EPA Science Inventory

Standard methods to measure recreational water quality require at least 24 hours to obtain results making it impossible to assess the quality of water within a single day. Methods to measure recreational water quality in two hours or less have been developed. Application of rapid...

CAN RAPID MEASURES OF RECREATIONAL WATER QUALITY PREDICT SWIMMING ASSOCIATED GASTROINTESTINAL ILLNESS?

EPA Science Inventory

Standard methods to measure recreational water quality require at least 24 hours to obtain results making it impossible to assess the quality of water within a single day. Methods to measure recreational water quality in two hours or less have been developed. Application of rapid...

Taichi exercise for self-rated sleep quality in older people: a systematic review and meta-analysis.

PubMed

Du, Shizheng; Dong, Jianshu; Zhang, Heng; Jin, Shengji; Xu, Guihua; Liu, Zengxia; Chen, Lixia; Yin, Haiyan; Sun, Zhiling

2015-01-01

Self-reported sleep disorders are common in older adults, resulting in serious consequences. Non-pharmacological measures are important complementary interventions, among which Taichi exercise is a popular alternative. Some experiments have been performed; however, the effect of Taichi exercise in improving sleep quality in older people has yet to be validated by systematic review. Using systematic review and meta-analysis, this study aimed to examine the efficacy of Taichi exercise in promoting self-reported sleep quality in older adults. Systematic review and meta-analysis of randomized controlled studies. 4 English databases: Pubmed, Cochrane Library, Web of Science and CINAHL, and 4 Chinese databases: CBMdisc, CNKI, VIP, and Wanfang database were searched through December 2013. Two reviewers independently selected eligible trials, conducted critical appraisal of the methodological quality by using the quality appraisal criteria for randomized controlled studies recommended by Cochrane Handbook. A standardized data form was used to extract information. Meta-analysis was performed. Five randomized controlled studies met inclusion criteria. All suffered from some methodological flaws. The results of this study showed that Taichi has large beneficial effect on sleep quality in older people, as indicated by decreases in the global Pittsburgh Sleep Quality Index score [standardized mean difference=-0.87, 95% confidence intervals (95% confidence interval) (-1.25, -0.49)], as well as its sub-domains of subjective sleep quality [standardized mean difference=-0.83, 95% confidence interval (-1.08, -0.57)], sleep latency [standardized mean difference=-0.75, 95% confidence interval (-1.42, -0.07)], sleep duration [standardized mean difference=-0.55, 95% confidence interval (-0.90, -0.21)], habitual sleep efficiency [standardized mean difference=-0.49, 95% confidence interval (-0.74, -0.23)], sleep disturbance [standardized mean difference=-0.44, 95% confidence interval (-0.69, -0.19)], and daytime dysfunction [standardized mean difference=-0.34, 95% confidence interval (-0.59, -0.09)]. Daytime sleepiness improvement was also observed. Weak evidence shows that Taichi exercise has a beneficial effect in improving self-rated sleep quality for older adults, suggesting that Taichi could be an effective alternative and complementary approach to existing therapies for older people with sleep problems. More rigorous experimental studies are required. Copyright © 2014 Elsevier Ltd. All rights reserved.

Real-life effectiveness of budesonide/formoterol therapy in asthma: A subanalysis of the SMARTASIA study.

PubMed

Lin, Jiangtao; Tang, Yan; Xiu, Qingyu; Kang, Jian; Cai, Shaoxi; Huang, Kewu; Itoh, Yohji; Ling, Xia; Zhong, Nanshan

2016-01-01

In the Study to Investigate Real Life Effectiveness of Symbicort Maintenance and Reliever Therapy in Asthma Patients Across Asia, the effectiveness of single-inhaler budesonide/formoterol maintenance and reliever therapy was evaluated in patients with poorly controlled asthma. To study the effects of this therapy on a Chinese patient subgroup. In this 12-week, multicenter, open-label therapeutic phase IV study, patients with partially controlled or uncontrolled asthma were switched from their usual asthma treatment to budesonide/formoterol (160/4.5 μg, one inhalation twice daily and as needed) after a 2-week run-in period. Primary and secondary objectives of the study, asthma control and quality of life were assessed by using the five-item Asthma Control Questionnaire and the Standardized Asthma Quality of Life Questionnaire. Asthma symptom scores, study medication use, asthma control and/or symptom-free days, and the number of asthma-related nighttime awakenings were also monitored. In total, 478 Chinese patients were enrolled and 407 patients initiated treatment. The patients displayed a significant improvement in mean (standard deviation) five-item Asthma Control Questionnaire (-0.58 ± 0.86; p < 0.0001) and Standardized Asthma Quality of Life Questionnaire (0.69 ± 0.79; p < 0.0001) scores versus the run-in period. Mean (standard deviation) asthma symptom scores were significantly reduced compared with run-in (-0.30 ± 0.55 daytime, -0.31 ± 0.56 nighttime; p < 0.0001 for both), as was as-needed study medication use (-0.24 ± 1.16 daytime, -0.28 ± 0.97 nighttime; p < 0.0001 for both). Patients who received previous treatment with salmeterol/fluticasone propionate also showed improvement in asthma control. In China, asthma control in Chinese patients whose asthma was not fully controlled with previous standard therapy improved during 12 weeks of treatment with budesonide/formoterol maintenance and reliever therapy. Quality of life was improved, and treatment was well tolerated. (Clinical Trials identifier NCT00939341).

Measuring the Effect of Housing Quality Interventions: The Case of the New Zealand “Rental Warrant of Fitness”

PubMed Central

Telfar-Barnard, Lucy; Bennett, Julie; Howden-Chapman, Philippa; Jacobs, David E.; Ormandy, David; Cutler-Welsh, Matthew; Preval, Nicholas; Baker, Michael G.; Keall, Michael

2017-01-01

In New Zealand, as in many other countries, housing in the private-rental sector is in worse condition than in the owner-occupier housing sector. New Zealand residential buildings have no inspection regime after original construction signoff. Laws and regulations mandating standards for existing residential housing are outdated and spread over a range of instruments. Policies to improve standards in existing housing have been notoriously difficult to implement. In this methods paper, we describe the development and implementation of a rental Warrant of Fitness (WoF) intended to address these problems. Dwellings must pass each of 29 criteria for habitability, insulation, heating, ventilation, safety, amenities, and basic structural soundness to reach the WoF minimum standard. The WoF’s development was based on two decades of research on the impact of housing quality on health and wellbeing, and strongly influenced by the UK Housing Health and Safety Rating System and US federal government housing standards. Criteria were field-tested across a range of dwelling types and sizes, cities, and climate zones. The implementation stage of our WoF research consists of a non-random controlled quasi-experimental study in which we work with two city-level local government councils to implement the rental WoF, recruiting adjoining council areas as controls, and measuring changes in health, economic, and social outcomes. PMID:29112147

40 CFR 50.4 - National primary ambient air quality standards for sulfur oxides (sulfur dioxide).

Code of Federal Regulations, 2011 CFR

2011-07-01

... standards for sulfur oxides (sulfur dioxide). 50.4 Section 50.4 Protection of Environment ENVIRONMENTAL....4 National primary ambient air quality standards for sulfur oxides (sulfur dioxide). (a) The level...). (c) Sulfur oxides shall be measured in the ambient air as sulfur dioxide by the reference method...

40 CFR 50.4 - National primary ambient air quality standards for sulfur oxides (sulfur dioxide).

Code of Federal Regulations, 2012 CFR

2012-07-01

... standards for sulfur oxides (sulfur dioxide). 50.4 Section 50.4 Protection of Environment ENVIRONMENTAL....4 National primary ambient air quality standards for sulfur oxides (sulfur dioxide). (a) The level...). (c) Sulfur oxides shall be measured in the ambient air as sulfur dioxide by the reference method...

40 CFR 50.4 - National primary ambient air quality standards for sulfur oxides (sulfur dioxide).

Code of Federal Regulations, 2013 CFR

2013-07-01

... standards for sulfur oxides (sulfur dioxide). 50.4 Section 50.4 Protection of Environment ENVIRONMENTAL....4 National primary ambient air quality standards for sulfur oxides (sulfur dioxide). (a) The level...). (c) Sulfur oxides shall be measured in the ambient air as sulfur dioxide by the reference method...

40 CFR 50.4 - National primary ambient air quality standards for sulfur oxides (sulfur dioxide).

Code of Federal Regulations, 2014 CFR

2014-07-01

... standards for sulfur oxides (sulfur dioxide). 50.4 Section 50.4 Protection of Environment ENVIRONMENTAL....4 National primary ambient air quality standards for sulfur oxides (sulfur dioxide). (a) The level...). (c) Sulfur oxides shall be measured in the ambient air as sulfur dioxide by the reference method...

Flexible solution for interoperable cloud healthcare systems.

PubMed

Vida, Mihaela Marcella; Lupşe, Oana Sorina; Stoicu-Tivadar, Lăcrămioara; Bernad, Elena

2012-01-01

It is extremely important for the healthcare domain to have a standardized communication because will improve the quality of information and in the end the resulting benefits will improve the quality of patients' life. The standards proposed to be used are: HL7 CDA and CCD. For a better access to the medical data a solution based on cloud computing (CC) is investigated. CC is a technology that supports flexibility, seamless care, and reduced costs of the medical act. To ensure interoperability between healthcare information systems a solution creating a Web Custom Control is presented. The control shows the database tables and fields used to configure the two standards. This control will facilitate the work of the medical staff and hospital administrators, because they can configure the local system easily and prepare it for communication with other systems. The resulted information will have a higher quality and will provide knowledge that will support better patient management and diagnosis.

The efficacy of physiotherapy upon shoulder function following axillary dissection in breast cancer, a randomized controlled study

PubMed Central

Beurskens, Carien HG; van Uden, Caro JT; Strobbe, Luc JA; Oostendorp, Rob AB; Wobbes, Theo

2007-01-01

Background Many patients suffer from severe shoulder complaints after breast cancer surgery and axillary lymph node dissection. Physiotherapy has been clinically observed to improve treatment of these patients. However, it is not a standard treatment regime. The purpose of this study is to investigate the efficacy of physiotherapy treatment of shoulder function, pain and quality of life in patients who have undergone breast cancer surgery and axillary lymph node dissection. Methods Thirty patients following breast cancer surgery and axillary lymph node dissection were included in a randomised controlled study. Assessments were made at baseline and after three and six months. The treatment group received standardised physiotherapy treatment of advice and exercises for the arm and shoulder for three months; the control group received a leaflet containing advice and exercises. If necessary soft tissue massage to the surgical scar was applied. Primary outcome variables were amount of pain in the shoulder/arm recorded on the Visual Analogue Scale, and shoulder mobility (flexion, abduction) measured using a digital inclinometer under standardized conditions. Secondary outcome measures were shoulder disabilities during daily activities, edema, grip strength of both hands and quality of life. The researcher was blinded to treatment allocation. Results All thirty patients completed the trial. After three and six months the treatment group showed a significant improvement in shoulder mobility and had significantly less pain than the control group. Quality of life improved significantly, however, handgrip strength and arm volume did not alter significantly. Conclusion Physiotherapy reduces pain and improves shoulder function and quality of life following axillary dissection after breast cancer. Trial registration ISRCTN31186536 PMID:17760981

Developmental validation of a Nextera XT mitogenome Illumina MiSeq sequencing method for high-quality samples.

PubMed

Peck, Michelle A; Sturk-Andreaggi, Kimberly; Thomas, Jacqueline T; Oliver, Robert S; Barritt-Ross, Suzanne; Marshall, Charla

2018-05-01

Generating mitochondrial genome (mitogenome) data from reference samples in a rapid and efficient manner is critical to harnessing the greater power of discrimination of the entire mitochondrial DNA (mtDNA) marker. The method of long-range target enrichment, Nextera XT library preparation, and Illumina sequencing on the MiSeq is a well-established technique for generating mitogenome data from high-quality samples. To this end, a validation was conducted for this mitogenome method processing up to 24 samples simultaneously along with analysis in the CLC Genomics Workbench and utilizing the AQME (AFDIL-QIAGEN mtDNA Expert) tool to generate forensic profiles. This validation followed the Federal Bureau of Investigation's Quality Assurance Standards (QAS) for forensic DNA testing laboratories and the Scientific Working Group on DNA Analysis Methods (SWGDAM) validation guidelines. The evaluation of control DNA, non-probative samples, blank controls, mixtures, and nonhuman samples demonstrated the validity of this method. Specifically, the sensitivity was established at ≥25 pg of nuclear DNA input for accurate mitogenome profile generation. Unreproducible low-level variants were observed in samples with low amplicon yields. Further, variant quality was shown to be a useful metric for identifying sequencing error and crosstalk. Success of this method was demonstrated with a variety of reference sample substrates and extract types. These studies further demonstrate the advantages of using NGS techniques by highlighting the quantitative nature of heteroplasmy detection. The results presented herein from more than 175 samples processed in ten sequencing runs, show this mitogenome sequencing method and analysis strategy to be valid for the generation of reference data. Copyright © 2018 Elsevier B.V. All rights reserved.

Quality, Organization Design, and Standards.

ERIC Educational Resources Information Center

Gardner, James F.

1992-01-01

This paper discusses regulations and voluntary standards within the context of organizational mission and management leadership for quality in human services. Regulation is seen as a measure of organizational formalism; formalism is seen as an attribute of the machine organization; and both are contrasted to organic control organization models and…

Distance management of inflammatory bowel disease: Systematic review and meta-analysis

PubMed Central

Huang, Vivian W; Reich, Krista M; Fedorak, Richard N

2014-01-01

AIM: To review the effectiveness of distance management methods in the management of adult inflammatory bowel disease (IBD) patients. METHODS: A systematic review and meta-analysis of randomized controlled trials comparing distance management and standard clinic follow-up in the management of adult IBD patients. Distance management intervention was defined as any remote management method in which there is a patient self-management component whereby the patient interacts remotely via a self-guided management program, electronic interface, or self-directs open access to clinic follow up. The search strategy included electronic databases (Medline, PubMed, CINAHL, The Cochrane Central Register of Controlled Trials, EMBASE, KTPlus, Web of Science, and SCOPUS), conference proceedings, and internet search for web publications. The primary outcome was the mean difference in quality of life, and the secondary outcomes included mean difference in relapse rate, clinic visit rate, and hospital admission rate. Study selection, data extraction, and risk of bias assessment were completed by two independent reviewers. RESULTS: The search strategy identified a total of 4061 articles, but only 6 randomized controlled trials met the inclusion and exclusion criteria for the systematic review and meta-analysis. Three trials involved telemanagement, and three trials involved directed patient self-management and open access clinics. The total sample size was 1463 patients. There was a trend towards improved quality of life in distance management patients with an end IBDQ quality of life score being 7.28 (95%CI: -3.25-17.81) points higher than standard clinic follow-up. There was a significant decrease in the clinic visit rate among distance management patients mean difference -1.08 (95%CI: -1.60--0.55), but no significant change in relapse rate or hospital admission rate. CONCLUSION: Distance management of IBD significantly decreases clinic visit utilization, but does not significantly affect relapse rates or hospital admission rates. PMID:24574756

Exposing the Science in Citizen Science: Fitness to Purpose and Intentional Design.

PubMed

Parrish, Julia K; Burgess, Hillary; Weltzin, Jake F; Fortson, Lucy; Wiggins, Andrea; Simmons, Brooke

2018-05-21

Citizen science is a growing phenomenon. With millions of people involved and billions of in-kind dollars contributed annually, this broad extent, fine grain approach to data collection should be garnering enthusiastic support in the mainstream science and higher education communities. However, many academic researchers demonstrate distinct biases against the use of citizen science as a source of rigorous information. To engage the public in scientific research, and the research community in the practice of citizen science, a mutual understanding is needed of accepted quality standards in science, and the corresponding specifics of project design and implementation when working with a broad public base. We define a science-based typology focused on the degree to which projects deliver the type(s) and quality of data/work needed to produce valid scientific outcomes directly useful in science and natural resource management. Where project intent includes direct contribution to science and the public is actively involved either virtually or hands-on, we examine the measures of quality assurance (methods to increase data quality during the design and implementation phases of a project) and quality control (post hoc methods to increase the quality of scientific outcomes). We suggest that high quality science can be produced with massive, largely one-off, participation if data collection is simple and quality control includes algorithm voting, statistical pruning and/or computational modeling. Small to mid-scale projects engaging participants in repeated, often complex, sampling can advance quality through expert-led training and well-designed materials, and through independent verification. Both approaches - simplification at scale and complexity with care - generate more robust science outcomes.

[Output standard in the mental health services of Reggio Emilia, Italy. Methodological issues].

PubMed

Grassi, G

2000-01-01

The project Output Standards of the Mental Health Department (MHD) of Reggio Emilia is set out to define outputs and quality standards and to guarantee transparency and to facilitate organizational improvement. The MHD started an interprofessional working group that defined the MHD outputs as long as process, quality peculiarities, indicators and standards for each output. The MHD Director validated the group results. The MHD defined 9 outputs and its indicators and standards and consequently modified its data registration system, the way to supply free and partially charged services and budget indicators. As a result, a new instrument for management and quality control has been provided. The A. maintains that to define outputs, indicators and standards will allow to compare several services of the Department, get them omogeneous and guarantee and improve quality.