ENVIRONMENTAL TECHNOLOGY VERIFICATION REPORT, MIRATECH CORPORATIONM GECO 3001 AIR/FUEL RATIO CONTROLLER

EPA Science Inventory

Details on the verification test design, measurement test procedures, and Quality assurance/Quality Control (QA/QC) procedures can be found in the test plan titled Testing and Quality Assurance Plan, MIRATECH Corporation GECO 3100 Air/Fuel Ratio Controller (SRI 2001). It can be d...

21 CFR 106.90 - Coding.

Code of Federal Regulations, 2010 CFR

2010-04-01

... CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES Quality Control Procedures for Assuring Nutrient Content of Infant Formulas § 106.90 Coding. The manufacturer shall code all infant formulas in conformity...

21 CFR 106.20 - Ingredient control.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Ingredient control. 106.20 Section 106.20 Food and... CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES Quality Control Procedures for Assuring Nutrient Content of Infant Formulas § 106.20 Ingredient control. (a) Except as provided in § 106.20(b), no analysis...

21 CFR 106.20 - Ingredient control.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Ingredient control. 106.20 Section 106.20 Food and... CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES Quality Control Procedures for Assuring Nutrient Content of Infant Formulas § 106.20 Ingredient control. (a) Except as provided in § 106.20(b), no analysis...

21 CFR 106.20 - Ingredient control.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Ingredient control. 106.20 Section 106.20 Food and... CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES Quality Control Procedures for Assuring Nutrient Content of Infant Formulas § 106.20 Ingredient control. (a) Except as provided in § 106.20(b), no analysis...

21 CFR 106.20 - Ingredient control.

Code of Federal Regulations, 2010 CFR

2010-04-01

... CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES Quality Control Procedures for Assuring Nutrient Content of Infant Formulas § 106.20 Ingredient control. (a) Except as provided in § 106.20(b), no analysis... prepared by the infant formula manufacturer shall be sampled and analyzed for each relied-upon nutrient...

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.

21 CFR 106.20 - Ingredient control.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Ingredient control. 106.20 Section 106.20 Food and... CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES (Eff. until 7-10-14) Quality Control Procedures for Assuring Nutrient Content of Infant Formulas § 106.20 Ingredient control. (a) Except as provided in § 106...

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...

Quality-assurance data for routine water quality analyses by the U. S. Geological Survey laboratory in Troy, New York; July 1993 through June 1995

USGS Publications Warehouse

Lincoln, Tricia A.; Horan-Ross, Debra A.; McHale, Michael R.; Lawrence, Gregory B.

2001-01-01

A laboratory for analysis of low-ionic strength water has been developed at the U.S. Geological Survey (USGS) office in Troy, N.Y., to analyze samples collected by USGS projects in the Northeast. The laboratory's quality-assurance program is based on internal and interlaboratory quality-assurance samples and quality-control procedures developed to ensure proper sample collection, processing, and analysis. The quality-assurance/quality-control data are stored in the laboratory's SAS data-management system, which provides efficient review, compilation, and plotting of quality-assurance/quality-control data. This report presents and discusses samples analyzed from July 1993 through June 1995. Quality-control results for 18 analytical procedures were evaluated for bias and precision. Control charts show that data from seven of the analytical procedures were biased throughout the analysis period for either high-concentration or low-concentration samples but were within control limits; these procedures were: acid-neutralizing capacity, dissolved inorganic carbon, dissolved organic carbon (soil expulsions), chloride, magnesium, nitrate (colorimetric method), and pH. Three of the analytical procedures were occasionally biased but were within control limits; they were: calcium (high for high-concentration samples for May 1995), dissolved organic carbon (high for highconcentration samples from January through September 1994), and fluoride (high in samples for April and June 1994). No quality-control sample has been developed for the organic monomeric aluminum procedure. Results from the filter-blank and analytical-blank analyses indicate that all analytical procedures in which blanks were run were within control limits, although values for a few blanks were outside the control limits. Blanks were not analyzed for acid-neutralizing capacity, dissolved inorganic carbon, fluoride, nitrate (colorimetric method), or pH. Sampling and analysis precision are evaluated herein in terms of the coefficient of variation obtained for triplicate samples in 14 of the 18 procedures. Data-quality objectives were met by more than 90 percent of the samples analyzed in all procedures except total monomeric aluminum (85 percent of samples met objectives), total aluminum (70 percent of samples met objectives), and dissolved organic carbon (85 percent of samples met objectives). Triplicate samples were not analyzed for ammonium, fluoride, dissolved inorganic carbon, or nitrate (colorimetric method). Results of the USGS interlaboratory Standard Reference Sample Program indicated high data quality with a median result of 3.6 of a possible 4.0. Environment Canada's LRTAP interlaboratory study results indicated that more than 85 percent of the samples met data-quality objectives in 6 of the 12 analyses; exceptions were calcium, dissolved organic carbon, chloride, pH, potassium, and sodium. Data-quality objectives were not met for calcium samples in one LRTAP study, but 94 percent of samples analyzed were within control limits for the remaining studies. Data-quality objectives were not met by 35 percent of samples analyzed for dissolved organic carbon, but 94 percent of sample values were within 20 percent of the most probable value. Data-quality objectives were not met for 30 percent of samples analyzed for chloride, but 90 percent of sample values were within 20 percent of the most probable value. Measurements of samples with a pH above 6.0 were biased high in 54 percent of the samples, although 85 percent of the samples met data-quality objectives for pH measurements below 6.0. Data-quality objectives for potassium and sodium were not met in one study (only 33 percent of the samples analyzed met the objectives), although 85 percent of the sample values were within control limits for the other studies. Measured sodium values were above the upper control limit in all studies. Results from blind reference-sample analyses indicated that data

10 CFR 26.137 - Quality assurance and quality control.

Code of Federal Regulations, 2013 CFR

2013-01-01

... validation of analytical procedures. Quality assurance procedures must be designed, implemented, and reviewed... resolving any technical, methodological, or administrative errors in the licensee testing facility's testing...

10 CFR 26.137 - Quality assurance and quality control.

Code of Federal Regulations, 2010 CFR

2010-01-01

... validation of analytical procedures. Quality assurance procedures must be designed, implemented, and reviewed... resolving any technical, methodological, or administrative errors in the licensee testing facility's testing...

10 CFR 26.137 - Quality assurance and quality control.

Code of Federal Regulations, 2011 CFR

2011-01-01

... validation of analytical procedures. Quality assurance procedures must be designed, implemented, and reviewed... resolving any technical, methodological, or administrative errors in the licensee testing facility's testing...

10 CFR 26.137 - Quality assurance and quality control.

Code of Federal Regulations, 2012 CFR

2012-01-01

... validation of analytical procedures. Quality assurance procedures must be designed, implemented, and reviewed... resolving any technical, methodological, or administrative errors in the licensee testing facility's testing...

10 CFR 26.137 - Quality assurance and quality control.

Code of Federal Regulations, 2014 CFR

2014-01-01

... validation of analytical procedures. Quality assurance procedures must be designed, implemented, and reviewed... resolving any technical, methodological, or administrative errors in the licensee testing facility's testing...

21 CFR 106.1 - Status and applicability of the quality control procedures regulation.

Code of Federal Regulations, 2011 CFR

2011-04-01

... AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES... infant formula meets the safety, quality, and nutrient requirements of section 412 of the act and the..., processing, and packaging of an infant formula shall render such formula adulterated under section 412(a)(1...

21 CFR 106.1 - Status and applicability of the quality control procedures regulation.

Code of Federal Regulations, 2010 CFR

2010-04-01

... AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES... infant formula meets the safety, quality, and nutrient requirements of section 412 of the act and the..., processing, and packaging of an infant formula shall render such formula adulterated under section 412(a)(1...

Quality-Assurance Data for Routine Water Analyses by the U.S. Geological Survey Laboratory in Troy, New York - July 2005 through June 2007

USGS Publications Warehouse

Lincoln, Tricia A.; Horan-Ross, Debra A.; McHale, Michael R.; Lawrence, Gregory B.

2009-01-01

The laboratory for analysis of low-ionic-strength water at the U.S. Geological Survey (USGS) Water Science Center in Troy, N.Y., analyzes samples collected by USGS projects throughout the Northeast. The laboratory's quality-assurance program is based on internal and interlaboratory quality-assurance samples and quality-control procedures that were developed to ensure proper sample collection, processing, and analysis. The quality-assurance and quality-control data were stored in the laboratory's Lab Master data-management system, which provides efficient review, compilation, and plotting of data. This report presents and discusses results of quality-assurance and quality control samples analyzed from July 2005 through June 2007. Results for the quality-control samples for 19 analytical procedures were evaluated for bias and precision. Control charts indicate that data for eight of the analytical procedures were occasionally biased for either high-concentration or low-concentration samples but were within control limits; these procedures were: total aluminum, calcium, magnesium, nitrate (colorimetric method), potassium, silicon, sodium, and sulfate. Eight of the analytical procedures were biased throughout the analysis period for the high-concentration sample, but were within control limits; these procedures were: total aluminum, calcium, dissolved organic carbon, chloride, nitrate (ion chromatograph), potassium, silicon, and sulfate. The magnesium and pH procedures were biased throughout the analysis period for the low-concentration sample, but were within control limits. The acid-neutralizing capacity, total monomeric aluminum, nitrite, and specific conductance procedures were biased for the high-concentration and low-concentration samples, but were within control limits. Results from the filter-blank and analytical-blank analyses indicated that the procedures for 16 of 17 analytes were within control limits, although the concentrations for blanks were occasionally outside the control limits. The data-quality objective was not met for dissolved organic carbon. Sampling and analysis precision are evaluated herein in terms of the coefficient of variation obtained for triplicate samples in the procedures for 18 of the 21 analytes. At least 93 percent of the samples met data-quality objectives for all analytes except acid-neutralizing capacity (85 percent of samples met objectives), total monomeric aluminum (83 percent of samples met objectives), total aluminum (85 percent of samples met objectives), and chloride (85 percent of samples met objectives). The ammonium and total dissolved nitrogen did not meet the data-quality objectives. Results of the USGS interlaboratory Standard Reference Sample (SRS) Project met the Troy Laboratory data-quality objectives for 87 percent of the samples analyzed. The P-sample (low-ionic-strength constituents) analysis had two outliers each in two studies. The T-sample (trace constituents) analysis and the N-sample (nutrient constituents) analysis had one outlier each in two studies. Results of Environment Canada's National Water Research Institute (NWRI) program indicated that at least 85 percent of the samples met data-quality objectives for 11 of the 14 analytes; the exceptions were acid-neutralizing capacity, total aluminum and ammonium. Data-quality objectives were not met in 41 percent of samples analyzed for acid-neutralizing capacity, 50 percent of samples analyzed for total aluminum, and 44 percent of samples analyzed for ammonium. Results from blind reference-sample analyses indicated that data-quality objectives were met by at least 86 percent of the samples analyzed for calcium, magnesium, pH, potassium, and sodium. Data-quality objectives were met by 76 percent of the samples analyzed for chloride, 80 percent of the samples analyzed for specific conductance, and 77 percent of the samples analyzed for sulfate.

Application of Sigma Metrics Analysis for the Assessment and Modification of Quality Control Program in the Clinical Chemistry Laboratory of a Tertiary Care Hospital.

PubMed

Iqbal, Sahar; Mustansar, Tazeen

2017-03-01

Sigma is a metric that quantifies the performance of a process as a rate of Defects-Per-Million opportunities. In clinical laboratories, sigma metric analysis is used to assess the performance of laboratory process system. Sigma metric is also used as a quality management strategy for a laboratory process to improve the quality by addressing the errors after identification. The aim of this study is to evaluate the errors in quality control of analytical phase of laboratory system by sigma metric. For this purpose sigma metric analysis was done for analytes using the internal and external quality control as quality indicators. Results of sigma metric analysis were used to identify the gaps and need for modification in the strategy of laboratory quality control procedure. Sigma metric was calculated for quality control program of ten clinical chemistry analytes including glucose, chloride, cholesterol, triglyceride, HDL, albumin, direct bilirubin, total bilirubin, protein and creatinine, at two control levels. To calculate the sigma metric imprecision and bias was calculated with internal and external quality control data, respectively. The minimum acceptable performance was considered as 3 sigma. Westgard sigma rules were applied to customize the quality control procedure. Sigma level was found acceptable (≥3) for glucose (L2), cholesterol, triglyceride, HDL, direct bilirubin and creatinine at both levels of control. For rest of the analytes sigma metric was found <3. The lowest value for sigma was found for chloride (1.1) at L2. The highest value of sigma was found for creatinine (10.1) at L3. HDL was found with the highest sigma values at both control levels (8.8 and 8.0 at L2 and L3, respectively). We conclude that analytes with the sigma value <3 are required strict monitoring and modification in quality control procedure. In this study application of sigma rules provided us the practical solution for improved and focused design of QC procedure.

[Quality control in anesthesiology].

PubMed

Muñoz-Ramón, J M

1995-03-01

The process of quality control and auditing of anesthesiology allows us to evaluate care given by a service and solve problems that are detected. Quality control is a basic element of care giving and is only secondarily an area of academic research; it is therefore a meaningless effort if the information does not serve to improve departmental procedures. Quality assurance procedures assume certain infrastructural requirements and an initial period of implementation and adjustment. The main objectives of quality control are the reduction of morbidity and mortality due to anesthesia, assurance of the availability and proper management of resources and, finally, the well-being and safety of the patient.

Diagnostic equipment outside the laboratory.

PubMed Central

Burrin, J M; Fyffe, J A

1988-01-01

A questionnaire was circulated to clinical biochemistry laboratories in the North West Thames region of the United Kingdom requesting information on extralaboratory equipment. Data on the types and numbers of instruments in use, their relationship with the laboratory, and quality assurance procedures were obtained. Laboratories were prepared to maintain equipment over which they had no responsibility for purchase, training of users, or use. The quality assurance of these instruments gave even greater cause for concern. Although internal quality control procedures were performed on many of the instruments, laboratories were involved in only a minority of these procedures. Quality control procedures and training of users were undertaken on site in less than 50% of blood gas analysers and bilirubin meters and in less than 25% of glucose meters. External quality assessment procedures were non-existent for all of the instruments in use with the exception of glucose stick meters in two laboratories. PMID:3192750

46 CFR 164.019-13 - Production quality control requirements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 6 2011-10-01 2011-10-01 false Production quality control requirements. 164.019-13....019-13 Production quality control requirements. (a) General. Each component manufacturer shall establish procedures for maintaining quality control of the materials used in production, manufacturing...

46 CFR 164.019-13 - Production quality control requirements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 6 2012-10-01 2012-10-01 false Production quality control requirements. 164.019-13....019-13 Production quality control requirements. (a) General. Each component manufacturer shall establish procedures for maintaining quality control of the materials used in production, manufacturing...

46 CFR 164.019-13 - Production quality control requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 6 2010-10-01 2010-10-01 false Production quality control requirements. 164.019-13....019-13 Production quality control requirements. (a) General. Each component manufacturer shall establish procedures for maintaining quality control of the materials used in production, manufacturing...

46 CFR 164.019-13 - Production quality control requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 6 2014-10-01 2014-10-01 false Production quality control requirements. 164.019-13....019-13 Production quality control requirements. (a) General. Each component manufacturer shall establish procedures for maintaining quality control of the materials used in production, manufacturing...

46 CFR 164.019-13 - Production quality control requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 6 2013-10-01 2013-10-01 false Production quality control requirements. 164.019-13....019-13 Production quality control requirements. (a) General. Each component manufacturer shall establish procedures for maintaining quality control of the materials used in production, manufacturing...

7 CFR 58.928 - Quality control tests.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 3 2011-01-01 2011-01-01 false Quality control tests. 58.928 Section 58.928... Procedures § 58.928 Quality control tests. All dairy products and other ingredients shall be subject to inspection for quality and condition throughout each processing operation. Quality control tests shall be...

7 CFR 58.335 - Quality control tests.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 3 2011-01-01 2011-01-01 false Quality control tests. 58.335 Section 58.335... Procedures § 58.335 Quality control tests. All milk, cream and related products are subject to inspection for quality and condition throughout each processing operation. Quality control tests shall be made on flow...

42 CFR 478.10 - Scope.

Code of Federal Regulations, 2010 CFR

2010-10-01

... FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) QUALITY IMPROVEMENT ORGANIZATIONS RECONSIDERATIONS AND APPEALS Utilization and Quality Control Quality Improvement... procedures for— (a) Reconsiderations conducted by a Utilization and Quality Control Quality Improvement...

42 CFR 478.10 - Scope.

Code of Federal Regulations, 2011 CFR

2011-10-01

... FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) QUALITY IMPROVEMENT ORGANIZATIONS RECONSIDERATIONS AND APPEALS Utilization and Quality Control Quality Improvement... procedures for— (a) Reconsiderations conducted by a Utilization and Quality Control Quality Improvement...

42 CFR 478.10 - Scope.

Code of Federal Regulations, 2012 CFR

2012-10-01

... FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) QUALITY IMPROVEMENT ORGANIZATIONS RECONSIDERATIONS AND APPEALS Utilization and Quality Control Quality Improvement... procedures for— (a) Reconsiderations conducted by a Utilization and Quality Control Quality Improvement...

42 CFR 478.10 - Scope.

Code of Federal Regulations, 2013 CFR

2013-10-01

... FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) QUALITY IMPROVEMENT ORGANIZATIONS RECONSIDERATIONS AND APPEALS Utilization and Quality Control Quality Improvement... procedures for— (a) Reconsiderations conducted by a Utilization and Quality Control Quality Improvement...

42 CFR 478.10 - Scope.

Code of Federal Regulations, 2014 CFR

2014-10-01

... FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) QUALITY IMPROVEMENT ORGANIZATIONS RECONSIDERATIONS AND APPEALS Utilization and Quality Control Quality Improvement... procedures for— (a) Reconsiderations conducted by a Utilization and Quality Control Quality Improvement...

Internal quality control: planning and implementation strategies.

PubMed

Westgard, James O

2003-11-01

The first essential in setting up internal quality control (IQC) of a test procedure in the clinical laboratory is to select the proper IQC procedure to implement, i.e. choosing the statistical criteria or control rules, and the number of control measurements, according to the quality required for the test and the observed performance of the method. Then the right IQC procedure must be properly implemented. This review focuses on strategies for planning and implementing IQC procedures in order to improve the quality of the IQC. A quantitative planning process is described that can be implemented with graphical tools such as power function or critical-error graphs and charts of operating specifications. Finally, a total QC strategy is formulated to minimize cost and maximize quality. A general strategy for IQC implementation is recommended that employs a three-stage design in which the first stage provides high error detection, the second stage low false rejection and the third stage prescribes the length of the analytical run, making use of an algorithm involving the average of normal patients' data.

21 CFR 106.90 - Coding.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Coding. 106.90 Section 106.90 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES Quality Control Procedures for Assuring Nutrient Content...

21 CFR 106.90 - Coding.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Coding. 106.90 Section 106.90 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES Quality Control Procedures for Assuring Nutrient Content...

21 CFR 106.90 - Coding.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Coding. 106.90 Section 106.90 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES Quality Control Procedures for Assuring Nutrient Content...

Parameter Trending, Geolocation Quality Control and the Procedures to Support Preparation of Next Versions of the TRMM Reprocessing Algorithm

NASA Technical Reports Server (NTRS)

Stocker, Erich Franz

2004-01-01

TRMM has been an imminently successful mission from an engineering standpoint but even more from a science standpoint. An important part of this science success has been the careful quality control of the TRMM standard products. This paper will present the quality monitoring efforts that the TRMM Science Data and Information System (TSDIS) conducts on a routine basis. The paper will detail parameter trending, geolocation quality control and the procedures to support the preparation of next versions of the algorithm used for reprocessing.

Mesh quality control for multiply-refined tetrahedral grids

NASA Technical Reports Server (NTRS)

Biswas, Rupak; Strawn, Roger

1994-01-01

A new algorithm for controlling the quality of multiply-refined tetrahedral meshes is presented in this paper. The basic dynamic mesh adaption procedure allows localized grid refinement and coarsening to efficiently capture aerodynamic flow features in computational fluid dynamics problems; however, repeated application of the procedure may significantly deteriorate the quality of the mesh. Results presented show the effectiveness of this mesh quality algorithm and its potential in the area of helicopter aerodynamics and acoustics.

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.

Quality-Assurance Data for Routine Water Analyses by the U.S. Geological Survey Laboratory in Troy, New York-July 1997 through June 1999

USGS Publications Warehouse

Lincoln, Tricia A.; Horan-Ross, Debra A.; McHale, Michael R.; Lawrence, Gregory B.

2006-01-01

The laboratory for analysis of low-ionic-strength water at the U.S. Geological Survey (USGS) Water Science Center in Troy, N.Y., analyzes samples collected by USGS projects throughout the Northeast. The laboratory's quality-assurance program is based on internal and interlaboratory quality-assurance samples and quality-control procedures that were developed to ensure proper sample collection, processing, and analysis. The quality-assurance/quality-control data for the time period addressed in this report were stored in the laboratory's SAS data-management system, which provides efficient review, compilation, and plotting of data. This report presents and discusses results of quality-assurance and quality- control samples analyzed from July 1997 through June 1999. Results for the quality-control samples for 18 analytical procedures were evaluated for bias and precision. Control charts indicate that data for eight of the analytical procedures were occasionally biased for either high-concentration and (or) low-concentration samples but were within control limits; these procedures were: acid-neutralizing capacity, total monomeric aluminum, total aluminum, ammonium, calcium, chloride, specific conductance, and sulfate. The data from the potassium and sodium analytical procedures are insufficient for evaluation. Results from the filter-blank and analytical-blank analyses indicate that the procedures for 11 of 13 analytes were within control limits, although the concentrations for blanks were occasionally outside the control limits. Blank analysis results for chloride showed that 22 percent of blanks did not meet data-quality objectives and results for dissolved organic carbon showed that 31 percent of the blanks did not meet data-quality objectives. Sampling and analysis precision are evaluated herein in terms of the coefficient of variation obtained for triplicate samples in the procedures for 14 of the 18 analytes. At least 90 percent of the samples met data-quality objectives for all analytes except total aluminum (70 percent of samples met objectives) and potassium (83 percent of samples met objectives). Results of the USGS interlaboratory Standard Reference Sample (SRS) Project indicated good data quality for most constituents over the time period. The P-sample (low-ionic-strength constituents) analysis had good ratings in two of these studies and a satisfactory rating in the third. The results of the T-sample (trace constituents) analysis indicated high data quality with good ratings in all three studies. The N-sample (nutrient constituents) studies had one each of excellent, good, and satisfactory ratings. Results of Environment Canada's National Water Research Institute (NWRI) program indicated that at least 80 percent of the samples met data-quality objectives for 9 of the 13 analytes; the exceptions were dissolved organic carbon, ammonium, chloride, and specific conductance. Data-quality objectives were not met for dissolved organic carbon in two NWRI studies, but all of the samples were within control limits for the last study. Data-quality objectives were not met in 41 percent of samples analyzed for ammonium, 25 percent of samples analyzed for chloride, and 30 percent of samples analyzed for specific conductance. Results from blind reference-sample analyses indicated that data-quality objectives were met by at least 84 percent of the samples analyzed for calcium, chloride, magnesium, pH, and potassium. Data-quality objectives were met by 73 percent of those analyzed for sulfate. The data-quality objective was not met for sodium. The data are insufficient for evaluation of the specific conductance results.

14 CFR 21.139 - Quality control.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Quality control. 21.139 Section 21.139... PROCEDURES FOR PRODUCTS AND PARTS Production Certificates § 21.139 Quality control. The applicant must show that he has established and can maintain a quality control system for any product, for which he...

14 CFR 21.139 - Quality control.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 1 2011-01-01 2011-01-01 false Quality control. 21.139 Section 21.139... PROCEDURES FOR PRODUCTS AND PARTS Production Certificates § 21.139 Quality control. The applicant must show that he has established and can maintain a quality control system for any product, for which he...

46 CFR 164.120-11 - Production quality control requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 6 2014-10-01 2014-10-01 false Production quality control requirements. 164.120-11... Rescue Boats § 164.120-11 Production quality control requirements. The resin manufacturer must institute a quality control procedure to ensure that all Coast Guard-accepted resin is produced to the same...

46 CFR 164.120-11 - Production quality control requirements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 6 2012-10-01 2012-10-01 false Production quality control requirements. 164.120-11... Rescue Boats § 164.120-11 Production quality control requirements. The resin manufacturer must institute a quality control procedure to ensure that all Coast Guard-accepted resin is produced to the same...

46 CFR 164.120-11 - Production quality control requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 6 2013-10-01 2013-10-01 false Production quality control requirements. 164.120-11... Rescue Boats § 164.120-11 Production quality control requirements. The resin manufacturer must institute a quality control procedure to ensure that all Coast Guard-accepted resin is produced to the same...

7 CFR 58.928 - Quality control tests.

Code of Federal Regulations, 2013 CFR

2013-01-01

... quality test shall be made to determine product stability. ... 7 Agriculture 3 2013-01-01 2013-01-01 false Quality control tests. 58.928 Section 58.928... Procedures § 58.928 Quality control tests. All dairy products and other ingredients shall be subject to...

7 CFR 58.928 - Quality control tests.

Code of Federal Regulations, 2012 CFR

2012-01-01

... quality test shall be made to determine product stability. ... 7 Agriculture 3 2012-01-01 2012-01-01 false Quality control tests. 58.928 Section 58.928... Procedures § 58.928 Quality control tests. All dairy products and other ingredients shall be subject to...

Standard Reference Specimens in Quality Control of Engineering Surfaces

PubMed Central

Song, J. F.; Vorburger, T. V.

1991-01-01

In the quality control of engineering surfaces, we aim to understand and maintain a good relationship between the manufacturing process and surface function. This is achieved by controlling the surface texture. The control process involves: 1) learning the functional parameters and their control values through controlled experiments or through a long history of production and use; 2) maintaining high accuracy and reproducibility with measurements not only of roughness calibration specimens but also of real engineering parts. In this paper, the characteristics, utilizations, and limitations of different classes of precision roughness calibration specimens are described. A measuring procedure of engineering surfaces, based on the calibration procedure of roughness specimens at NIST, is proposed. This procedure involves utilization of check specimens with waveform, wavelength, and other roughness parameters similar to functioning engineering surfaces. These check specimens would be certified under standardized reference measuring conditions, or by a reference instrument, and could be used for overall checking of the measuring procedure and for maintaining accuracy and agreement in engineering surface measurement. The concept of “surface texture design” is also suggested, which involves designing the engineering surface texture, the manufacturing process, and the quality control procedure to meet the optimal functional needs. PMID:28184115

28 CFR 104.71 - Procedures to prevent and detect fraud.

Code of Federal Regulations, 2010 CFR

2010-07-01

.... 104.71 Section 104.71 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) SEPTEMBER 11TH VICTIM... prevent and detect fraud. (a) Review of claims. For the purpose of detecting and preventing the payment of...; and (3) Ensure the quality control of claims review procedures. (b) Quality control. The Special...

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

7 CFR 58.523 - Laboratory and quality control tests.

Code of Federal Regulations, 2014 CFR

2014-01-01

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

7 CFR 58.523 - Laboratory and quality control tests.

Code of Federal Regulations, 2010 CFR

2010-01-01

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

7 CFR 58.523 - Laboratory and quality control tests.

Code of Federal Regulations, 2013 CFR

2013-01-01

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

7 CFR 58.523 - Laboratory and quality control tests.

Code of Federal Regulations, 2011 CFR

2011-01-01

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

7 CFR 58.523 - Laboratory and quality control tests.

Code of Federal Regulations, 2012 CFR

2012-01-01

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

7 CFR 58.149 - Alternate quality control programs for dairy products.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 3 2011-01-01 2011-01-01 false Alternate quality control programs for dairy products... and Grading Service 1 Operations and Operating Procedures § 58.149 Alternate quality control programs for dairy products. (a) When a plant has in operation an acceptable quality control program which is...

QUALITY SYSTEMS AND IMPLEMENTATION PLAN FOR A PILOT STUDY OF CHILDREN'S TOTAL EXPOSURE TO PERSISTENT PESTICIDES AND OTHER PERSISTENT ORGANIC PESTICIDES (CTEPP)

EPA Science Inventory

The Quality System Implementation Plan (QSIP) describes the quality assurance and quality control procedures developed for the CTEPP study. It provides the QA/QC procedures used in recruitment of subjects, sample field collection, sample extraction and analysis, data storage, and...

7 CFR 58.733 - Quality control tests.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 3 2011-01-01 2011-01-01 false Quality control tests. 58.733 Section 58.733... Procedures § 58.733 Quality control tests. (a) Chemical analyses. The following chemical analyses shall be... pasteurization by means of the phosphatase test, as well as any other tests necessary to assure good quality...

30 CFR 74.6 - Quality control.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Quality control. 74.6 Section 74.6 Mineral... of the CMDPSU will be maintained in production through adequate quality control procedures, MSHA and... DUST SAMPLING DEVICES Approval Requirements for Coal Mine Dust Personal Sampler Unit § 74.6 Quality...

7 CFR 58.733 - Quality control tests.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 3 2010-01-01 2010-01-01 false Quality control tests. 58.733 Section 58.733... Procedures § 58.733 Quality control tests. (a) Chemical analyses. The following chemical analyses shall be... pasteurization by means of the phosphatase test, as well as any other tests necessary to assure good quality...

Standardisation of DNA quantitation by image analysis: quality control of instrumentation.

PubMed

Puech, M; Giroud, F

1999-05-01

DNA image analysis is frequently performed in clinical practice as a prognostic tool and to improve diagnosis. The precision of prognosis and diagnosis depends on the accuracy of analysis and particularly on the quality of image analysis systems. It has been reported that image analysis systems used for DNA quantification differ widely in their characteristics (Thunissen et al.: Cytometry 27: 21-25, 1997). This induces inter-laboratory variations when the same sample is analysed in different laboratories. In microscopic image analysis, the principal instrumentation errors arise from the optical and electronic parts of systems. They bring about problems of instability, non-linearity, and shading and glare phenomena. The aim of this study is to establish tools and standardised quality control procedures for microscopic image analysis systems. Specific reference standard slides have been developed to control instability, non-linearity, shading and glare phenomena and segmentation efficiency. Some systems have been controlled with these tools and these quality control procedures. Interpretation criteria and accuracy limits of these quality control procedures are proposed according to the conclusions of a European project called PRESS project (Prototype Reference Standard Slide). Beyond these limits, tested image analysis systems are not qualified to realise precise DNA analysis. The different procedures presented in this work determine if an image analysis system is qualified to deliver sufficiently precise DNA measurements for cancer case analysis. If the controlled systems are beyond the defined limits, some recommendations are given to find a solution to the problem.

Software quality assurance plan for GCS

NASA Technical Reports Server (NTRS)

Duncan, Stephen E.; Bailey, Elizabeth K.

1990-01-01

The software quality assurance (SQA) function for the Guidance and Control Software (GCS) project which is part of a software error studies research program is described. The SQA plan outlines all of the procedures, controls, and audits to be carried out by the SQA organization to ensure adherence to the policies, procedures, and standards for the GCS project.

30 CFR 74.6 - Quality control.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Quality control. 74.6 Section 74.6 Mineral... control. The applicant shall describe the way in which each lot of components will be sampled and tested... of the CMDPSU will be maintained in production through adequate quality control procedures, MSHA and...

7 CFR 58.929 - Frequency of sampling for quality control.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 3 2011-01-01 2011-01-01 false Frequency of sampling for quality control. 58.929... Service 1 Operations and Operating Procedures § 58.929 Frequency of sampling for quality control. (a... to control composition. On continuous production runs, enough samples shall be taken throughout the...

7 CFR 58.442 - Laboratory and quality control tests.

Code of Federal Regulations, 2010 CFR

2010-01-01

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

7 CFR 58.442 - Laboratory and quality control tests.

Code of Federal Regulations, 2011 CFR

2011-01-01

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

30 CFR 74.6 - Quality control.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Quality control. 74.6 Section 74.6 Mineral... control. The applicant shall describe the way in which each lot of components will be sampled and tested... of the CMDPSU will be maintained in production through adequate quality control procedures, MSHA and...

30 CFR 74.6 - Quality control.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Quality control. 74.6 Section 74.6 Mineral... control. The applicant shall describe the way in which each lot of components will be sampled and tested... of the CMDPSU will be maintained in production through adequate quality control procedures, MSHA and...

23 CFR 650.313 - Inspection procedures.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) Quality control and quality assurance. Assure systematic quality control (QC) and quality assurance (QA... periodic field review of inspection teams, periodic bridge inspection refresher training for program managers and team leaders, and independent review of inspection reports and computations. (h) Follow-up on...

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...

TECHNICAL GUIDANCE DOCUMENT: QUALITY ASSURANCE AND QUALITY CONTROL FOR WASTE CONTAINMENT FACILITIES

EPA Science Inventory

This Technical Guidance Document provides comprehensive guidance on procedures for quality assurance and quality control for waste containment facilities. he document includes a discussion of principles and concepts, compacted soil liners, soil drainage systems, geosynthetic drai...

TECHNICAL GUIDANCE DOCUMENT: QUALITY ASSURANCE AND QUALITY CONTROL FOR WASTE CONTAINMENT FACILITIES

EPA Science Inventory

This Technical Guidance Document provides comprehensive guidance on procedures for quality assurance and quality control for waste containment facilities. The document includes a discussion of principles and concepts, compacted soil liners, soil drainage systems, geosynthetic dr...

Data Quality Control of the French Permanent Broadband Network in the RESIF Framework

NASA Astrophysics Data System (ADS)

Grunberg, Marc; Lambotte, Sophie; Engels, Fabien; Dretzen, Remi; Hernandez, Alain

2014-05-01

In the framework of the RESIF (Réseau Sismologique et géodésique Français) project, a new information system is being setting up, allowing the improvement of the management and the distribution of high quality data from the different elements of RESIF and the associated networks. Within this information system, EOST (in Strasbourg) is in charge of collecting real-time permanent broadband seismic waveform, and performing Quality Control on these data. The real-time and validated data set are pushed to the French National Distribution Center (Isterre/Grenoble) in order to make them publicly available. Furthermore EOST hosts the BCSF-ReNaSS, in charge of the French metropolitan seismic bulletin. This allows to benefit from some high-end quality control based on the national and world-wide seismicity. Here we present first the real-time seismic data flow from the stations of the French National Broad Band Network to EOST, and then, the data Quality Control procedures that were recently installed, including some new developments. The data Quality Control consists in applying a variety of subprocesses to check the consistency of the whole system and process from the stations to the data center. This allows us to verify that instruments and data transmission are operating correctly. Moreover analysis of the ambient noise helps to characterize intrinsic seismic quality of the stations and to identify other kind of disturbances. The deployed Quality Control consist in a pipeline that starts with low-level procedures : check the real-time miniseed data file (file naming convention, data integrity), check for inconsistencies between waveform and meta-data (channel name, sample rate, etc.), compute waveform statistics (data availability, gap/overlap, mean, rms, time quality, spike). It is followed by some high-level procedures such as : power spectral density computation (PSD), STA/LTA computation to be correlated to the seismicity, phases picking and stations magnitudes discrepancies. The results of quality control is visualized through a web interface. This latter gathers data from different information systems to provide a global view on last events that could impact the data (like intervention on site or seismic events, etc.). This work is still an ongoing project. We intend to add more sophisticated procedures to enhanced our data Quality Control. Among them, we will deploy a seismic moment tensor inversion tool for amplitude, time and polarity control and a noise correlation procedure for time drift detections.

Current good manufacturing practices, quality control procedures, quality factors, notification requirements, and records and reports, for infant formula. Final rule.

PubMed

2014-06-10

The Food and Drug Administration (FDA or we) is issuing a final rule that adopts, with some modifications, the interim final rule (IFR) entitled "Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula'' (February 10, 2014). This final rule affirms the IFR's changes to FDA's regulations and provides additional modifications and clarifications. The final rule also responds to certain comments submitted in response to the request for comments in the IFR.

Principles and Practices for Quality Assurance and Quality Control

USGS Publications Warehouse

Jones, Berwyn E.

1999-01-01

Quality assurance and quality control are vital parts of highway runoff water-quality monitoring projects. To be effective, project quality assurance must address all aspects of the project, including project management responsibilities and resources, data quality objectives, sampling and analysis plans, data-collection protocols, data quality-control plans, data-assessment procedures and requirements, and project outputs. Quality control ensures that the data quality objectives are achieved as planned. The historical development and current state of the art of quality assurance and quality control concepts described in this report can be applied to evaluation of data from prior projects.

Assessment of average of normals (AON) procedure for outlier-free datasets including qualitative values below limit of detection (LoD): an application within tumor markers such as CA 15-3, CA 125, and CA 19-9.

PubMed

Usta, Murat; Aral, Hale; Mete Çilingirtürk, Ahmet; Kural, Alev; Topaç, Ibrahim; Semerci, Tuna; Hicri Köseoğlu, Mehmet

2016-11-01

Average of normals (AON) is a quality control procedure that is sensitive only to systematic errors that can occur in an analytical process in which patient test results are used. The aim of this study was to develop an alternative model in order to apply the AON quality control procedure to datasets that include qualitative values below limit of detection (LoD). The reported patient test results for tumor markers, such as CA 15-3, CA 125, and CA 19-9, analyzed by two instruments, were retrieved from the information system over a period of 5 months, using the calibrator and control materials with the same lot numbers. The median as a measure of central tendency and the median absolute deviation (MAD) as a measure of dispersion were used for the complementary model of AON quality control procedure. The u bias values, which were determined for the bias component of the measurement uncertainty, were partially linked to the percentages of the daily median values of the test results that fall within the control limits. The results for these tumor markers, in which lower limits of reference intervals are not medically important for clinical diagnosis and management, showed that the AON quality control procedure, using the MAD around the median, can be applied for datasets including qualitative values below LoD.

40 CFR Appendix B to Part 75 - Quality Assurance and Quality Control Procedures

Code of Federal Regulations, 2012 CFR

2012-07-01

... Systems 1.2.1Calibration Error Test and Linearity Check Procedures Keep a written record of the procedures used for daily calibration error tests and linearity checks (e.g., how gases are to be injected..., and when calibration adjustments should be made). Identify any calibration error test and linearity...

40 CFR Appendix B to Part 75 - Quality Assurance and Quality Control Procedures

Code of Federal Regulations, 2013 CFR

2013-07-01

... Systems 1.2.1Calibration Error Test and Linearity Check Procedures Keep a written record of the procedures used for daily calibration error tests and linearity checks (e.g., how gases are to be injected..., and when calibration adjustments should be made). Identify any calibration error test and linearity...

21 CFR 106.30 - Finished product evaluation.

Code of Federal Regulations, 2014 CFR

2014-04-01

... FOR HUMAN CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES (Eff. until 7-10-14) Quality Control... the maintenance of nutrient content throughout the shelf life of the product. (c) The manufacturer... nutrients, and the biological quality of the protein. A protein biological quality analysis is not necessary...

21 CFR 820.40 - Document controls.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Document controls. 820.40 Section 820.40 Food and... QUALITY SYSTEM REGULATION Document Controls § 820.40 Document controls. Each manufacturer shall establish and maintain procedures to control all documents that are required by this part. The procedures shall...

21 CFR 820.40 - Document controls.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Document controls. 820.40 Section 820.40 Food and... QUALITY SYSTEM REGULATION Document Controls § 820.40 Document controls. Each manufacturer shall establish and maintain procedures to control all documents that are required by this part. The procedures shall...

21 CFR 820.40 - Document controls.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Document controls. 820.40 Section 820.40 Food and... QUALITY SYSTEM REGULATION Document Controls § 820.40 Document controls. Each manufacturer shall establish and maintain procedures to control all documents that are required by this part. The procedures shall...

21 CFR 820.40 - Document controls.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Document controls. 820.40 Section 820.40 Food and... QUALITY SYSTEM REGULATION Document Controls § 820.40 Document controls. Each manufacturer shall establish and maintain procedures to control all documents that are required by this part. The procedures shall...

21 CFR 820.40 - Document controls.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Document controls. 820.40 Section 820.40 Food and... QUALITY SYSTEM REGULATION Document Controls § 820.40 Document controls. Each manufacturer shall establish and maintain procedures to control all documents that are required by this part. The procedures shall...

COMMUNITY MULTISCALE AIR QUALITY ( CMAQ ) MODEL - QUALITY ASSURANCE AND VERSION CONTROL

EPA Science Inventory

This presentation will be given to the EPA Exposure Modeling Workgroup on January 24, 2006. The quality assurance and version control procedures for the Community Multiscale Air Quality (CMAQ) Model are presented. A brief background of CMAQ is given, then issues related to qual...

Quality Assurance and Quality Control, Part 2.

PubMed

Akers, Michael J

2015-01-01

The tragedy surrounding the New England Compounding Center and contaminated steroid syringe preparations clearly points out what can happen if quality-assurance and quality-control procedures are not strictly practiced in the compounding of sterile preparations. This article is part 2 of a two-part article on requirements to comply with United States Pharmacopeia general chapters <797> and <1163> with respect to quality assurance of compounded sterile preparations. Part 1 covered documentation requirements, inspection procedures, compounding accuracy checks, and part of a discussion on bacterial endotoxin testing. Part 2 covers sterility testing, the completion from part 1 on bacterial endotoxin testing, a brief dicussion of United States Pharmacopeia <1163>, and advances in pharmaceutical quality systems.

Instrument Quality Control.

PubMed

Jayakody, Chatura; Hull-Ryde, Emily A

2016-01-01

Well-defined quality control (QC) processes are used to determine whether a certain procedure or action conforms to a widely accepted standard and/or set of guidelines, and are important components of any laboratory quality assurance program (Popa-Burke et al., J Biomol Screen 14: 1017-1030, 2009). In this chapter, we describe QC procedures useful for monitoring the accuracy and precision of laboratory instrumentation, most notably automated liquid dispensers. Two techniques, gravimetric QC and photometric QC, are highlighted in this chapter. When used together, these simple techniques provide a robust process for evaluating liquid handler accuracy and precision, and critically underpin high-quality research programs.

An NCME Instructional Module on Quality Control Procedures in the Scoring, Equating, and Reporting of Test Scores

ERIC Educational Resources Information Center

Allalouf, Avi

2007-01-01

There is significant potential for error in long production processes that consist of sequential stages, each of which is heavily dependent on the previous stage, such as the SER (Scoring, Equating, and Reporting) process. Quality control procedures are required in order to monitor this process and to reduce the number of mistakes to a minimum. In…

TU-FG-201-12: Designing a Risk-Based Quality Assurance Program for a Newly Implemented Y-90 Microspheres Procedure

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

Vile, D; Zhang, L; Cuttino, L

2016-06-15

Purpose: To create a quality assurance program based upon a risk-based assessment of a newly implemented SirSpheres Y-90 procedure. Methods: A process map was created for a newly implemented SirSpheres procedure at a community hospital. The process map documented each step of this collaborative procedure, as well as the roles and responsibilities of each member. From the process map, different potential failure modes were determined as well as any current controls in place. From this list, a full failure mode and effects analysis (FMEA) was performed by grading each failure mode’s likelihood of occurrence, likelihood of detection, and potential severity.more » These numbers were then multiplied to compute the risk priority number (RPN) for each potential failure mode. Failure modes were then ranked based on their RPN. Additional controls were then added, with failure modes corresponding to the highest RPNs taking priority. Results: A process map was created that succinctly outlined each step in the SirSpheres procedure in its current implementation. From this, 72 potential failure modes were identified and ranked according to their associated RPN. Quality assurance controls and safety barriers were then added for failure modes associated with the highest risk being addressed first. Conclusion: A quality assurance program was created from a risk-based assessment of the SirSpheres process. Process mapping and FMEA were effective in identifying potential high-risk failure modes for this new procedure, which were prioritized for new quality assurance controls. TG 100 recommends the fault tree analysis methodology to design a comprehensive and effective QC/QM program, yet we found that by simply introducing additional safety barriers to address high RPN failure modes makes the whole process simpler and safer.« less

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

Progressing quality control in environmental impact assessment beyond legislative compliance: An evaluation of the IEMA EIA Quality Mark certification scheme

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

Bond, Alan, E-mail: alan.bond@uea.ac.uk; Research Unit for Environmental Sciences and Management, North-West University; Fischer, Thomas B, E-mail: fischer@liverpool.ac.uk

The effectiveness of Environmental Impact Assessment (EIA) systems is contingent on a number of control mechanisms: procedural; judicial; evaluative; public and government agency; professional; and development aid agency. If we assume that procedural and judicial controls are guaranteed in developed EIA systems, then progressing effectiveness towards an acceptable level depends on improving the performance of other control mechanisms over time. These other control mechanisms are either absent, or are typically centrally controlled, requiring public finances; this we argue is an unpopular model in times of greater Government austerity. Here we evaluate a market-based mechanism for improving the performance of evaluativemore » and professional control mechanisms, the UK Institute of Environmental Management and Assessments' EIA Quality Mark. We do this by defining dimensions of effectiveness for the purposes of our evaluation, and by identifying international examples of the approaches taken to delivering the other control measures to validate the approach taken in the EIA Quality Mark. We then evaluate the EIA Quality Mark, when used in combination with legal procedures and an active judiciary, against the effectiveness dimensions and use time-series analysis of registrant data to examine its ability to progress practice. We conclude that the EIA Quality Mark has merit as a model for a market-based mechanism, and may prove a more financially palatable approach for delivering effective EIA in mature systems in countries that lack centralised agency oversight. It may, therefore, be of particular interest to some Member States of the European Union for ensuring forthcoming certification requirements stemming from recent amendments to the EIA Directive. - Highlights: • Quality control mechanisms in EIA are identified. • Effectiveness of EIA is conceptualised for evaluation purposes. • The UK IEMA EIA Quality Mark is introduced as a market-based mechanism. • The EIA Quality Mark is found to progress quality in many, but not all, areas.« less

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.

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.

21 CFR 111.103 - What are the requirements under this subpart F for written procedures?

Code of Federal Regulations, 2010 CFR

2010-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... quality control operations, including written procedures for conducting a material review and making a...

Evaluation of non-destructive technologies for construction quality control of HMA and PCC pavements in Louisiana.

DOT National Transportation Integrated Search

2013-11-01

Current roadway quality control and quality acceptance (QC/QA) procedures for the Louisiana Department of Transportation and : Development (LADOTD) include coring for thickness, density, and air voids in hot mix asphalt (HMA) pavements and thickness ...

40 CFR Appendix B to Part 75 - Quality Assurance and Quality Control Procedures

Code of Federal Regulations, 2010 CFR

2010-07-01

... in section 2.3 of this appendix and the Hg emission tests described in §§ 75.81(c) and 75.81(d)(4). 1.2Specific Requirements for Continuous Emissions Monitoring Systems 1.2.1Calibration Error Test and Linearity Check Procedures Keep a written record of the procedures used for daily calibration error tests and...

U.S. Geological Survey Noble Gas Laboratory’s standard operating procedures for the measurement of dissolved gas in water samples

USGS Publications Warehouse

Hunt, Andrew G.

2015-08-12

This report addresses the standard operating procedures used by the U.S. Geological Survey’s Noble Gas Laboratory in Denver, Colorado, U.S.A., for the measurement of dissolved gases (methane, nitrogen, oxygen, and carbon dioxide) and noble gas isotopes (helium-3, helium-4, neon-20, neon-21, neon-22, argon-36, argon-38, argon-40, kryton-84, krypton-86, xenon-103, and xenon-132) dissolved in water. A synopsis of the instrumentation used, procedures followed, calibration practices, standards used, and a quality assurance and quality control program is presented. The report outlines the day-to-day operation of the Residual Gas Analyzer Model 200, Mass Analyzer Products Model 215–50, and ultralow vacuum extraction line along with the sample handling procedures, noble gas extraction and purification, instrument measurement procedures, instrumental data acquisition, and calculations for the conversion of raw data from the mass spectrometer into noble gas concentrations per unit mass of water analyzed. Techniques for the preparation of artificial dissolved gas standards are detailed and coupled to a quality assurance and quality control program to present the accuracy of the procedures used in the laboratory.

30 CFR 74.6 - Quality control.

Code of Federal Regulations, 2010 CFR

2010-07-01

... DUST SAMPLING DEVICES Approval Requirements for Coal Mine Dust Personal Sampler Unit § 74.6 Quality... equipment procedures and records and to interview the employees who conduct the control tests. Two copies of...

Ambient Monitoring Technology Information Center (AMTIC)

EPA Pesticide Factsheets

This site contains information on ambient air quality monitoring programs, monitoring methods, quality assurance and control procedures, and federal regulations related to ambient air quality monitoring.

Data Quality Assurance and Control for AmeriFlux Network at CDIAC, ORNL

NASA Astrophysics Data System (ADS)

Shem, W.; Boden, T.; Krassovski, M.; Yang, B.

2014-12-01

The Carbon Dioxide Information Analysis Center (CDIAC) at the Oak Ridge National Laboratory (ORNL) serves as the long-term data repository for the AmeriFlux network. Datasets currently available include hourly or half-hourly meteorological and flux observations, biological measurement records, and synthesis data products. Currently there is a lack of standardized nomenclature and specifically designed procedures for data quality assurance/control in processing and handling micrometeorological and ecological data at individual flux sites. CDIAC's has bridged this gap by providing efficient and accurate procedures for data quality control and standardization of the results for easier assimilation by the models used in climate science. In this presentation we highlight the procedures we have put in place to scrutinize continuous flux and meteorological data within Ameriflux network. We itemize some basic data quality issues that we have observed over the past years and include some examples of typical data quality issues. Such issues, e.g., incorrect time-stamping, poor calibration or maintenance of instruments, missing or incomplete metadata and others that are commonly over-looked by PI's, invariably impact the time-series observations.

The construction of control chart for PM10 functional data

NASA Astrophysics Data System (ADS)

Shaadan, Norshahida; Jemain, Abdul Aziz; Deni, Sayang Mohd

2014-06-01

In this paper, a statistical procedure to construct a control chart for monitoring air quality (PM10) using functional data is proposed. A set of daily indices that represent the daily PM10 curves were obtained using Functional Principal Component Analysis (FPCA). By means of an iterative charting procedure, a reference data set that represented a stable PM10 process was obtained. The data were then used as a reference for monitoring future data. The application of the procedure was conducted using seven-year (2004-2010) period of recorded data from the Klang air quality monitoring station located in the Klang Valley region of Peninsular Malaysia. The study showed that the control chart provided a useful visualization tool for monitoring air quality and was capable in detecting abnormality in the process system. As in the case of Klang station, the results showed that with reference to 2004-2008, the air quality (PM10) in 2010 was better than that in 2009.

Evaluation of non-destructive technologies for construction quality control of HMA and PCC pavements in Louisiana : [tech summary].

DOT National Transportation Integrated Search

2013-11-01

Current roadway quality control and quality acceptance (QC/QA) procedures for the Louisiana Department of Transportation and Development : (LADOTD) include coring for thickness, density, and air voids in hot mix asphalt (HMA) pavements and thickness ...

Enhancement of the Automated Quality Control Procedures for the International Soil Moisture Network

NASA Astrophysics Data System (ADS)

Heer, Elsa; Xaver, Angelika; Dorigo, Wouter; Messner, Romina

2017-04-01

In-situ soil moisture observations are still trusted to be the most reliable data to validate remotely sensed soil moisture products. Thus, the quality of in-situ soil moisture observations is of high importance. The International Soil Moisture Network (ISMN; http://ismn.geo.tuwien.ac.at/) provides in-situ soil moisture data from all around the world. The data is collected from individual networks and data providers, measured by different sensors in various depths. The data sets which are delivered in different units, time zones and data formats are then transformed into homogeneous data sets. An erroneous behavior of soil moisture data is very difficult to detect, due to annual and daily changes and most significantly the high influence of precipitation and snow melting processes. Only few of the network providers have a quality assessment for their data sets. Therefore, advanced quality control procedures have been developed for the ISMN (Dorigo et al. 2013). Three categories of quality checks were introduced: exceeding boundary values, geophysical consistency checks and a spectrum based approach. The spectrum based quality control algorithms aim to detect erroneous measurements which occur within plausible geophysical ranges, e.g. a sudden drop in soil moisture caused by a sensor malfunction. By defining several conditions which have to be met by the original soil moisture time series and their first and second derivative, such error types can be detected. Since the development of these sophisticated methods many more data providers shared their data with the ISMN and new types of erroneous measurements were identified. Thus, an enhancement of the automated quality control procedures became necessary. In the present work, we introduce enhancements of the existing quality control algorithms. Additionally, six completely new quality checks have been developed, e.g. detection of suspicious values before or after NAN-values, constant values and values that lie in a spectrum where a high majority of values before and after is flagged and therefore a sensor malfunction is certain. For the evaluation of the enhanced automated quality control system many test data sets were chosen, and manually validated to be compared to the existing quality control procedures and the new algorithms. Improvements will be shown that assure an appropriate assessment of the ISMN data sets, which are used for validations of soil moisture data retrieved by satellite data and are the foundation many other scientific publications.

Synthesis and quality control of fluorodeoxyglucose and performance assessment of Siemens MicroFocus 220 small animal PET scanner

NASA Astrophysics Data System (ADS)

Phaterpekar, Siddhesh Nitin

The scope of this article is to cover the synthesis and quality control procedures involved in production of Fludeoxyglucose (18F--FDG). The article also describes the cyclotron production of 18F radioisotope and gives a brief overview on operations and working of a fixed energy medical cyclotron. The quality control procedures for FDG involve radiochemical and radionuclidic purity tests, pH tests, chemical purity tests, sterility tests, endotoxin tests. Each of these procedures were carried out for multiple batches of FDG with a passing rate of 95% among 20 batches. The article also covers the quality assurance steps for the Siemens MicroPET Focus 220 Scanner using a Jaszczak phantom. We have carried out spatial resolution tests on the scanner, with an average transaxial resolution of 1.775mm with 2-3mm offset. Tests involved detector efficiency, blank scan sinograms and transmission sinograms. A series of radioactivity distribution tests are also carried out on a uniform phantom, denoting the variations in radioactivity and uniformity by using cylindrical ROIs in the transverse region of the final image. The purpose of these quality control tests is to make sure the manufactured FDG is biocompatible with the human body. Quality assurance tests are carried on PET scanners for efficient performance, and to make sure the quality of images acquired is according to the radioactivity distribution in the subject of interest.

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

29 CFR 1910.7 - Definition and requirements for a nationally recognized testing laboratory.

Code of Federal Regulations, 2012 CFR

2012-07-01

..., written testing procedures, and calibration and quality control programs) to perform: (i) Testing and... test standards; or (ii) Experimental testing and examining of equipment and materials for workplace..., labeled, or accepted, the following controls or services: (i) Implements control procedures for...

Internal quality control in serological tests for syphilis.

PubMed Central

Wasley, G D

1985-01-01

The importance of syphilis serological tests demands that laboratory reports are reliable. Internal quality control applied to the organisation of a syphilis serology service improves laboratory bench performance and reporting. Described here are internal quality control procedures of a department that serves a genitourinary medicine clinic and conducts 70 000 tests a year to investigate for syphilis. PMID:3884487

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...

Parameters of Quality Control and Decision Making At the State Level.

ERIC Educational Resources Information Center

Merkel-Keller, Claudia

The recommendation is made that Elementary Secondary Education Act Title I data should be subjected to quality control procedures at local, state, and national levels. An industrial quality control model may provide a useful approach, particularly at the state level. A brief description of the Title I Evaluation and Reporting System is given,…

Commercial jet fuel quality control

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

Strauss, K.H.

1995-05-01

The paper discusses the purpose of jet fuel quality control between the refinery and the aircraft. It describes fixed equipment, including various types of filters, and the usefulness and limitations of this equipment. Test equipment is reviewed as are various surveillance procedures. These include the Air Transport Association specification ATA 103, the FAA Advisory Circular 150/5230-4, the International Air Transport Association Guidance Material for Fuel Quality Control and Fuelling Service and the Guidelines for Quality Control at Jointly Operated Fuel Systems. Some past and current quality control problems are briefly mentioned.

Revision 2 of the Enbridge Quality Assurance Project Plan

EPA Pesticide Factsheets

This Quality Assurance Project Plan (QAPP) presents Revision 2 of the organization, objectives, planned activities, and specific quality assurance/quality control (QA/QC) procedures associated with the Enbridge Marshall Pipeline Release Project.

78 FR 28854 - Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-16

... formula regulations, including infant formula labeling, quality control procedures, notification....S.C. 350a) requires manufacturers of infant formula to establish and adhere to quality control..., including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility...

Evaluation of non-destructive technologies for construction quality control of HMA and PCC pavements in Louisiana : [research project capsule].

DOT National Transportation Integrated Search

2009-07-01

Current roadway quality control and quality acceptance (QC/QA) procedures : for Louisiana include coring for thickness, density, and air void checks in hot : mix asphalt (HMA) pavements and thickness and compressive strength for : Portland cement con...

Guidance for Efficient Small Animal Imaging Quality Control.

PubMed

Osborne, Dustin R; Kuntner, Claudia; Berr, Stuart; Stout, David

2017-08-01

Routine quality control is a critical aspect of properly maintaining high-performance small animal imaging instrumentation. A robust quality control program helps produce more reliable data both for academic purposes and as proof of system performance for contract imaging work. For preclinical imaging laboratories, the combination of costs and available resources often limits their ability to produce efficient and effective quality control programs. This work presents a series of simplified quality control procedures that are accessible to a wide range of preclinical imaging laboratories. Our intent is to provide minimum guidelines for routine quality control that can assist preclinical imaging specialists in setting up an appropriate quality control program for their facility.

Towards an integrated quality control procedure for eddy-covariance data

NASA Astrophysics Data System (ADS)

Vitale, Domenico; Papale, Dario

2017-04-01

The eddy-covariance technique is nowadays the most reliable and direct way, allowing to calculate the main fluxes of Sensible and Latent Heat and of Net Ecosystem Exchange, this last being the result of the difference between the CO2 assimilated by photosynthetic activities and those released to the atmosphere through the ecosystem respiration processes. Despite the improvements in accuracy of measurement instruments and software development, the eddy-covariance technique is not suitable under non-ideal conditions respect to the instruments characteristics and the physical assumption behind the technique mainly related to the well-developed and stationary turbulence conditions. Under these conditions the calculated fluxes are not reliable and need to be flagged and discarded. In order to discover these unavoidable "bad" fluxes and build dataset with the highest quality, several tests applied both on high-frequency (10-20 Hz) raw data and on half-hourly times series have been developed in the past years. Nevertheless, there is an increasing need to develop a standardized quality control procedure suitable not only for the analysis of long-term data, but also for the near-real time data processing. In this paper, we review established quality assessment procedures and present an innovative quality control strategy with the purpose of integrating the existing consolidated procedures with robust and advanced statistical tests more suitable for the analysis of time series data. The performance of the proposed quality control strategy is evaluated both on simulated and EC data distributed by the ICOS research infrastructure. It is concluded that the proposed strategy is able to flag and exclude unrealistic fluxes while being reproducible and retaining the largest possible amount of high quality data.

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...

21 CFR 226.40 - Production and control procedures.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Production and control procedures. 226.40 Section 226.40 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES Product Quality Control...

Importance of good manufacturing practices in microbiological monitoring in processing human tissues for transplant.

PubMed

Pianigiani, Elisa; Ierardi, Francesca; Fimiani, Michele

2013-12-01

Skin allografts represent an important therapeutic resource in the treatment of severe skin loss. The risk associated with application of processed tissues in humans is very low, however, human material always carries the risk of disease transmission. To minimise the risk of contamination of grafts, processing is carried out in clean rooms where air quality is monitored. Procedures and quality control tests are performed to standardise the production process and to guarantee the final product for human use. Since we only validate and distribute aseptic tissues, we conducted a study to determine what type of quality controls for skin processing are the most suitable for detecting processing errors and intercurrent contamination, and for faithfully mapping the process without unduly increasing production costs. Two different methods for quality control were statistically compared using the Fisher exact test. On the basis of the current study we selected our quality control procedure based on pre- and post-processing tissue controls, operator and environmental controls. Evaluation of the predictability of our control methods showed that tissue control was the most reliable method of revealing microbial contamination of grafts. We obtained 100 % sensitivity by doubling tissue controls, while maintaining high specificity (77 %).

Transoral Incisionless Fundoplication (TIF 2.0): A Meta-Analysis of Three Randomized, Controlled Clinical Trials.

PubMed

Gerson, Lauren; Stouch, Bruce; Lobonţiu, Adrian

2018-01-01

The TIF procedure has emerged as an endoscopic treatment for patients with refractory gastro-esophageal reflux disease (GERD). Previous systematic reviews of the TIF procedure conflated findings from studies with modalities that do not reflect the current 2.0 procedure technique or refined data-backed patient selection criteria. A meta-analysis was conducted using data only from randomized studies that assessed the TIF 2.0 procedure compared to a control. The purpose of the meta-analysis was to determine the efficacy and long-term outcomes associated with performance of the TIF 2.0 procedure in patients with chronic long-term refractory GERD on optimized PPI therapy, including esophageal pH, PPI utilization and quality of life. Methods: Three prospective research questions were predicated on the outcomes of the TIF procedure compared to patients who received PPI therapy or sham, concomitant treatment for GERD, and the patient-reported quality of life. Event rates were calculated using the random effect model. Since the time of follow-up post-TIF procedure was variable, analysis was performed to incorporate the time of follow-up for each individual patient at the 3-year time point. Results: Results from this meta-analysis, including data from 233 patients, demonstrated that TIF subjects at 3 years had improved esophageal pH, a decrease in PPI utilization, and improved quality of life. Conclusions: In a meta-analysis of randomized, controlled trials (RCTs), the TIF procedure data for patients with GERD refractory to PPI's produces significant changes, compared with sham or PPI therapy, in esophageal pH, decreased PPI utilization, and improved quality of life. Celsius.

75 FR 23777 - Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-04

... collection regarding the manufacture of infant formula, including infant formula labeling, quality control.... 350a) requires manufacturers of infant formula to establish and adhere to quality control procedures..., including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility...

External Quality Control Review of the Defense Information Systems Agency Audit Organization

DTIC Science & Technology

2012-08-07

We are providing this report for your information and use. We have reviewed the system of quality control for the audit organization of the Defense...audit organization encompasses the audit organization’s leadership, emphasis on performing high quality work, and policies and procedures established

Development of a quality control test procedure for characterizing fracture properties of asphalt mixtures.

DOT National Transportation Integrated Search

2011-06-01

The main objective of this study is to investigate the use of the semi-circular bend (SCB) : test as a quality assurance/quality control (QA/QC) measure for field construction. : Comparison of fracture properties from the SCB test and fatigue beam te...

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.

MASQOT: a method for cDNA microarray spot quality control

PubMed Central

Bylesjö, Max; Eriksson, Daniel; Sjödin, Andreas; Sjöström, Michael; Jansson, Stefan; Antti, Henrik; Trygg, Johan

2005-01-01

Background cDNA microarray technology has emerged as a major player in the parallel detection of biomolecules, but still suffers from fundamental technical problems. Identifying and removing unreliable data is crucial to prevent the risk of receiving illusive analysis results. Visual assessment of spot quality is still a common procedure, despite the time-consuming work of manually inspecting spots in the range of hundreds of thousands or more. Results A novel methodology for cDNA microarray spot quality control is outlined. Multivariate discriminant analysis was used to assess spot quality based on existing and novel descriptors. The presented methodology displays high reproducibility and was found superior in identifying unreliable data compared to other evaluated methodologies. Conclusion The proposed methodology for cDNA microarray spot quality control generates non-discrete values of spot quality which can be utilized as weights in subsequent analysis procedures as well as to discard spots of undesired quality using the suggested threshold values. The MASQOT approach provides a consistent assessment of spot quality and can be considered an alternative to the labor-intensive manual quality assessment process. PMID:16223442

9 CFR 381.309 - Finished product inspection.

Code of Federal Regulations, 2010 CFR

2010-01-01

... FSIS-approved total quality control system; or (3) Alternative documented procedures that will ensure... contamination, where there is no approved total quality control system, or where the establishment has no... Office of Management and Budget under control number 0583-0015) [51 FR 45634, Dec. 19, 1986, as amended...

Data Validation & Laboratory Quality Assurance for Region 9

EPA Pesticide Factsheets

In all hazardous site investigations it is essential to know the quality of the data used for decision-making purposes. Validation of data requires that appropriate quality assurance and quality control (QA/QC) procedures be followed.

Quality Management Plan for EPA Region 1

EPA Pesticide Factsheets

The QMP describes policies, procedures & management systems within EPA NE that govern quality assurance & quality control activities supporting the transparency & scientific defensibility of environmental data collected, used & disseminated by the Region.

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.

VERIFICATION TESTING OF AIR POLLUTION CONTROL TECHNOLOGY QUALITY MANAGEMENT PLAN

EPA Science Inventory

This document is the basis for quality assurance for the Air Pollution Control Technology Verification Center (APCT Center) operated under the U.S. Environmental Protection Agency (EPA). It describes the policies, organizational structure, responsibilities, procedures, and qualit...

UrQt: an efficient software for the Unsupervised Quality trimming of NGS data.

PubMed

Modolo, Laurent; Lerat, Emmanuelle

2015-04-29

Quality control is a necessary step of any Next Generation Sequencing analysis. Although customary, this step still requires manual interventions to empirically choose tuning parameters according to various quality statistics. Moreover, current quality control procedures that provide a "good quality" data set, are not optimal and discard many informative nucleotides. To address these drawbacks, we present a new quality control method, implemented in UrQt software, for Unsupervised Quality trimming of Next Generation Sequencing reads. Our trimming procedure relies on a well-defined probabilistic framework to detect the best segmentation between two segments of unreliable nucleotides, framing a segment of informative nucleotides. Our software only requires one user-friendly parameter to define the minimal quality threshold (phred score) to consider a nucleotide to be informative, which is independent of both the experiment and the quality of the data. This procedure is implemented in C++ in an efficient and parallelized software with a low memory footprint. We tested the performances of UrQt compared to the best-known trimming programs, on seven RNA and DNA sequencing experiments and demonstrated its optimality in the resulting tradeoff between the number of trimmed nucleotides and the quality objective. By finding the best segmentation to delimit a segment of good quality nucleotides, UrQt greatly increases the number of reads and of nucleotides that can be retained for a given quality objective. UrQt source files, binary executables for different operating systems and documentation are freely available (under the GPLv3) at the following address: https://lbbe.univ-lyon1.fr/-UrQt-.html .

78 FR 67327 - Approval and Promulgation of Air Quality Implementation Plans; State of Colorado; Revised...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-12

... shall include procedures for interagency consultation, conflict resolution, and public consultation... Determinations by the public, Air Quality Control Commission, and resolution of conflicts''. (2) 40 CFR 93.122(a... of 93.105(d) require specific procedures for resolving conflicts, and the provisions of 93.105(e...

NHEXAS PHASE I ARIZONA STUDY--STANDARD OPERATING PROCEDURE FOR FORM QA/QC CHECKS (UA-C-2.0)

EPA Science Inventory

The purpose of this SOP is to outline the process of Field Quality Assurance and Quality Control checks. This procedure was followed to ensure consistent data retrieval during the Arizona NHEXAS project and the "Border" study. Keywords: custody; QA/QC; field checks.

The Nation...

Spatial Data Quality Control Procedure applied to the Okavango Basin Information System

NASA Astrophysics Data System (ADS)

Butchart-Kuhlmann, Daniel

2014-05-01

Spatial data is a powerful form of information, capable of providing information of great interest and tremendous use to a variety of users. However, much like other data representing the 'real world', precision and accuracy must be high for the results of data analysis to be deemed reliable and thus applicable to real world projects and undertakings. The spatial data quality control (QC) procedure presented here was developed as the topic of a Master's thesis, in the sphere of and using data from the Okavango Basin Information System (OBIS), itself a part of The Future Okavango (TFO) project. The aim of the QC procedure was to form the basis of a method through which to determine the quality of spatial data relevant for application to hydrological, solute, and erosion transport modelling using the Jena Adaptable Modelling System (JAMS). As such, the quality of all data present in OBIS classified under the topics of elevation, geoscientific information, or inland waters, was evaluated. Since the initial data quality has been evaluated, efforts are underway to correct the errors found, thus improving the quality of the dataset.

[Features of the maintenance of automated developing machines].

PubMed

Koveshnikov, A I

1999-01-01

Based on his long-term own experience the author gives recommendations on the assembly, adjustment, operation, and preventive maintenance of automatic developing machines. Procedures are presented for evaluating the quality of X-ray films and controlling the activity of operating qualities of a developer while machining photographic materials. Troubles and malfunction of equipment and procedures for their elimination are shown to affect the quality of development of films.

42 CFR 480.104 - Procedures for disclosure by a QIO.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 480.104 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) QUALITY IMPROVEMENT ORGANIZATIONS ACQUISITION, PROTECTION, AND DISCLOSURE OF QUALITY IMPROVEMENT ORGANIZATION REVIEW INFORMATION Utilization and Quality Control Quality Improvement Organizations...

Modal control theory and application to aircraft lateral handling qualities design

NASA Technical Reports Server (NTRS)

Srinathkumar, S.

1978-01-01

A multivariable synthesis procedure based on eigenvalue/eigenvector assignment is reviewed and is employed to develop a systematic design procedure to meet the lateral handling qualities design objectives of a fighter aircraft over a wide range of flight conditions. The closed loop modal characterization developed provides significant insight into the design process and plays a pivotal role in the synthesis of robust feedback systems. The simplicity of the synthesis algorithm yields an efficient computer aided interactive design tool for flight control system synthesis.

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...

14 CFR 23.621 - Casting factors.

Code of Federal Regulations, 2011 CFR

2011-01-01

... either magnetic particle, penetrant or other approved equivalent non-destructive inspection method; or... percent approved non-destructive inspection. When an approved quality control procedure is established and...) of this section must be applied in addition to those necessary to establish foundry quality control...

Revisiting the Procedures for the Vector Data Quality Assurance in Practice

NASA Astrophysics Data System (ADS)

Erdoğan, M.; Torun, A.; Boyacı, D.

2012-07-01

Immense use of topographical data in spatial data visualization, business GIS (Geographic Information Systems) solutions and applications, mobile and location-based services forced the topo-data providers to create standard, up-to-date and complete data sets in a sustainable frame. Data quality has been studied and researched for more than two decades. There have been un-countable numbers of references on its semantics, its conceptual logical and representations and many applications on spatial databases and GIS. However, there is a gap between research and practice in the sense of spatial data quality which increases the costs and decreases the efficiency of data production. Spatial data quality is well-known by academia and industry but usually in different context. The research on spatial data quality stated several issues having practical use such as descriptive information, metadata, fulfillment of spatial relationships among data, integrity measures, geometric constraints etc. The industry and data producers realize them in three stages; pre-, co- and post data capturing. The pre-data capturing stage covers semantic modelling, data definition, cataloguing, modelling, data dictionary and schema creation processes. The co-data capturing stage covers general rules of spatial relationships, data and model specific rules such as topologic and model building relationships, geometric threshold, data extraction guidelines, object-object, object-belonging class, object-non-belonging class, class-class relationships to be taken into account during data capturing. And post-data capturing stage covers specified QC (quality check) benchmarks and checking compliance to general and specific rules. The vector data quality criteria are different from the views of producers and users. But these criteria are generally driven by the needs, expectations and feedbacks of the users. This paper presents a practical method which closes the gap between theory and practice. Development of spatial data quality concepts into developments and application requires existence of conceptual, logical and most importantly physical existence of data model, rules and knowledge of realization in a form of geo-spatial data. The applicable metrics and thresholds are determined on this concrete base. This study discusses application of geo-spatial data quality issues and QA (quality assurance) and QC procedures in the topographic data production. Firstly we introduce MGCP (Multinational Geospatial Co-production Program) data profile of NATO (North Atlantic Treaty Organization) DFDD (DGIWG Feature Data Dictionary), the requirements of data owner, the view of data producers for both data capturing and QC and finally QA to fulfil user needs. Then, our practical and new approach which divides the quality into three phases is introduced. Finally, implementation of our approach to accomplish metrics, measures and thresholds of quality definitions is discussed. In this paper, especially geometry and semantics quality and quality control procedures that can be performed by the producers are discussed. Some applicable best-practices that we experienced on techniques of quality control, defining regulations that define the objectives and data production procedures are given in the final remarks. These quality control procedures should include the visual checks over the source data, captured vector data and printouts, some automatic checks that can be performed by software and some semi-automatic checks by the interaction with quality control personnel. Finally, these quality control procedures should ensure the geometric, semantic, attribution and metadata quality of vector data.

42 CFR 480.104 - Procedures for disclosure by a QIO.

Code of Federal Regulations, 2012 CFR

2012-10-01

... SERVICES (CONTINUED) QUALITY IMPROVEMENT ORGANIZATIONS ACQUISITION, PROTECTION, AND DISCLOSURE OF QUALITY IMPROVEMENT ORGANIZATION INFORMATION Utilization and Quality Control Quality Improvement Organizations (QIOs...) Any disclosure of information under the authority of this subpart is subject to the requirements in...

42 CFR 480.104 - Procedures for disclosure by a QIO.

Code of Federal Regulations, 2011 CFR

2011-10-01

... SERVICES (CONTINUED) QUALITY IMPROVEMENT ORGANIZATIONS ACQUISITION, PROTECTION, AND DISCLOSURE OF QUALITY IMPROVEMENT ORGANIZATION REVIEW INFORMATION Utilization and Quality Control Quality Improvement Organizations... disclosure. (1) Any disclosure of information under the authority of this subpart is subject to the...

42 CFR 480.104 - Procedures for disclosure by a QIO.

Code of Federal Regulations, 2013 CFR

2013-10-01

... SERVICES (CONTINUED) QUALITY IMPROVEMENT ORGANIZATIONS ACQUISITION, PROTECTION, AND DISCLOSURE OF QUALITY IMPROVEMENT ORGANIZATION INFORMATION Utilization and Quality Control Quality Improvement Organizations (QIOs...) Any disclosure of information under the authority of this subpart is subject to the requirements in...

42 CFR 480.104 - Procedures for disclosure by a QIO.

Code of Federal Regulations, 2014 CFR

2014-10-01

... SERVICES (CONTINUED) QUALITY IMPROVEMENT ORGANIZATIONS ACQUISITION, PROTECTION, AND DISCLOSURE OF QUALITY IMPROVEMENT ORGANIZATION INFORMATION Utilization and Quality Control Quality Improvement Organizations (QIOs...) Any disclosure of information under the authority of this subpart is subject to the requirements in...

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...

Image processing system performance prediction and product quality evaluation

NASA Technical Reports Server (NTRS)

Stein, E. K.; Hammill, H. B. (Principal Investigator)

1976-01-01

The author has identified the following significant results. A new technique for image processing system performance prediction and product quality evaluation was developed. It was entirely objective, quantitative, and general, and should prove useful in system design and quality control. The technique and its application to determination of quality control procedures for the Earth Resources Technology Satellite NASA Data Processing Facility are described.

[Quality evaluation of the orthodontic practice for certification by ISO 9001. A procedure beneficial for medical, medico-dental or hospital service].

PubMed

Becker, G

2001-01-01

The accreditation of the ISO 9001 certification (ISO = International Standard Organization) is an external evaluation procedure carried out by independent experts, whose object is the analysis of the operational methods and practices of a medical care facility (e.g. hospital, private clinic, general practitioner's or dentist's practice) which decided to assume the concept, implementation and control of its own quality policy. The whole accreditation procedure represents the basic structure of a continuous dynamic progressiveness within a cabinet eager to offer outstanding quality. Moreover, it guarantees active and voluntary participation of every single member of the medical administration or technical team involved in the realization of this primary objective. In other words, we are talking about a very strong dynamic innovation leading to a change of views and the improvement of communication means, while simultaneously enhancing the security and quality aspects of medical care. The continuous guarantee of high quality medical care calls for precise planning and systematization of actions. First of all, these actions are defined, analyzed and listed in precise work procedures. As they are defined with the agreement of the whole team, they implicate respect and self control. This requires of course transparency of the treatment methods, whose different steps and procedures are described in detail in a logogramm set up in common.

[Coronary artery bypass surgery: methods of performance monitoring and quality control].

PubMed

Albert, A; Sergeant, P; Ennker, J

2009-10-01

The strength of coronary bypass operations depends on the preservation of their benefits regarding freedom of symptoms, quality of life and survival, over decades. Significant variability of the results of an operative intervention according to the hospital or the operating surgeon is considered a weakness in the procedure. The external quality insurance tries to reach a transparent service providing market through hospital ranking comparability. Widely available information and competition will promote the improvement of the whole quality. The structured dialog acts as a control instrument for the BQS (Federal Quality Insurance). It is launched in case of deviations from the standard references or statistically significant differences between the results of the operations in any hospital and the average notational results. In comparison to the external control the hospital internal control has greater ability to reach a medically useful statement regarding the results of the treatment and to correct the mistakes in time. An online information portal based on a departmental databank (DataWarehouse, DataMart) is an attractive solution for the physician in order to get transparently and timely informed about the variability in the performance.The individual surgeon significantly influences the short- and long-term treatment results. Accordingly, selection, targeted training and performance measurements are necessary.Strict risk management and failure analysis of individual cases are included in the methods of internal quality control aiming to identify and correct the inadequacies in the system and the course of treatment. According to the international as well as our own experience, at least 30% of the mortalities after bypass operations are avoidable. A functioning quality control is especially important in minimally invasive interventions because they are often technically more demanding in comparison to the conventional procedures. In the field of OPCAB surgery, the special advantages of the procedure can be utilised to reach a nearly complete avoidance of postoperative stroke through combining the procedure with aorta no-touch technique. The long-term success of the bypass operation depends on the type of bypass material in additions to many other factors. Both internal mammary arteries are considered the most durable.Using an operation preparation check contributes to the operative success.

Quality control of EUVE databases

NASA Technical Reports Server (NTRS)

John, L. M.; Drake, J.

1992-01-01

The publicly accessible databases for the Extreme Ultraviolet Explorer include: the EUVE Archive mailserver; the CEA ftp site; the EUVE Guest Observer Mailserver; and the Astronomical Data System node. The EUVE Performance Assurance team is responsible for verifying that these public EUVE databases are working properly, and that the public availability of EUVE data contained therein does not infringe any data rights which may have been assigned. In this poster, we describe the Quality Assurance (QA) procedures we have developed from the approach of QA as a service organization, thus reflecting the overall EUVE philosophy of Quality Assurance integrated into normal operating procedures, rather than imposed as an external, post facto, control mechanism.

Medical three-dimensional printing opens up new opportunities in cardiology and cardiac surgery.

PubMed

Bartel, Thomas; Rivard, Andrew; Jimenez, Alejandro; Mestres, Carlos A; Müller, Silvana

2018-04-14

Advanced percutaneous and surgical procedures in structural and congenital heart disease require precise pre-procedural planning and continuous quality control. Although current imaging modalities and post-processing software assists with peri-procedural guidance, their capabilities for spatial conceptualization remain limited in two- and three-dimensional representations. In contrast, 3D printing offers not only improved visualization for procedural planning, but provides substantial information on the accuracy of surgical reconstruction and device implantations. Peri-procedural 3D printing has the potential to set standards of quality assurance and individualized healthcare in cardiovascular medicine and surgery. Nowadays, a variety of clinical applications are available showing how accurate 3D computer reformatting and physical 3D printouts of native anatomy, embedded pathology, and implants are and how they may assist in the development of innovative therapies. Accurate imaging of pathology including target region for intervention, its anatomic features and spatial relation to the surrounding structures is critical for selecting optimal approach and evaluation of procedural results. This review describes clinical applications of 3D printing, outlines current limitations, and highlights future implications for quality control, advanced medical education and training.

[Recommendations for the control of documents and the establishment of a documentary system].

PubMed

Vinner, E

2013-06-01

The quality management system that must be implemented in a MBL to meet the requirements of the standard NF EN ISO 15189 is based, among other things, on the creation and use by staff of a documentary system approved and updated. This documentary system is constituted by external documents (standards, suppliers' documents...) and internal documents (quality manual, procedures, instructions, technical and quality recordings...). A procedure of the documentary system control must be formalized. The documentary system should be modeled in order to identify the various procedures to be drafted and the incurred risks in the case a document would be missing in this system. Each document must be indexed in a unique way and document management must be carried out rigorously. The use of document management software is a great help to manage the life cycle of documents.

Quality Assurance and Control Considerations in Environmental Measurements and Monitoring

NASA Astrophysics Data System (ADS)

Sedlet, Jacob

1982-06-01

Quality assurance and quality control have become accepted as essential parts of all environmental surveillance, measurements, and monitoring programs, both nuclear and non-nuclear. The same principles and details apply to each. It is primarily the final measurement technique that differs. As the desire and need to measure smaller amounts of pollutants with greater accuracy has increased, it has been recognized that quality assurance and control programs are cost-effective in achieving the expected results. Quality assurance (QA) consists of all the actions necessary to provide confidence in the results. Quality control (QC) is a part of QA, and consists of those actions and activities that permit the control of the individual steps in the environmental program. The distinction between the two terms is not always clearly defined, but a sharp division is not necessary. The essential principle of QA and QC is a commitment to high quality results. The essential components of a QA and QC program are a complete, written procedures manual for all parts of the environmental program, the use of standard or validated procedures, participation in applicable interlaboratory comparison or QA programs, replicate analysis and measurement, training of personnel, and a means of auditing or checking that the QA and QC programs are properly conducted. These components are discussed below in some detail.

ISO 9002 as Literacy Practice: Coping with Quality-Control Documents in a High-Tech Company

ERIC Educational Resources Information Center

Kleifgen, Jo Anne

2005-01-01

This study describes the process by which a circuit board manufacturing company became certified in an international quality control program known as ISO 9002. Particular attention is paid to how quality documents were made and used in actual practice and to the relationship between these standardized procedures (official literacies) and…

Quality in the Professions.

ERIC Educational Resources Information Center

Becher, Tony

1999-01-01

Reviews quality assurance and quality control procedures of the main requirements affecting United Kingdom medicine, pharmacy, law, accountancy, architecture, and structural engineering. Provides a taxonomy of different forms of quality maintenance and offers comparative material which may be of interest and relevance to academic readers. (EV)

Reporting the accuracy of biochemical measurements for epidemiologic and nutrition studies.

PubMed

McShane, L M; Clark, L C; Combs, G F; Turnbull, B W

1991-06-01

Procedures for reporting and monitoring the accuracy of biochemical measurements are presented. They are proposed as standard reporting procedures for laboratory assays for epidemiologic and clinical-nutrition studies. The recommended procedures require identification and estimation of all major sources of variability and explanations of laboratory quality control procedures employed. Variance-components techniques are used to model the total variability and calculate a maximum percent error that provides an easily understandable measure of laboratory precision accounting for all sources of variability. This avoids ambiguities encountered when reporting an SD that may taken into account only a few of the potential sources of variability. Other proposed uses of the total-variability model include estimating precision of laboratory methods for various replication schemes and developing effective quality control-checking schemes. These procedures are demonstrated with an example of the analysis of alpha-tocopherol in human plasma by using high-performance liquid chromatography.

Quality inspection of anisotropic scintillating lead tungstate (PbWO 4) crystals through measurement of interferometric fringe pattern parameters

NASA Astrophysics Data System (ADS)

Cocozzella, N.; Lebeau, M.; Majni, G.; Paone, N.; Rinaldi, D.

2001-08-01

Scintillating crystals are widely used as detectors in radiographic systems, computerized axial tomography devices and in calorimeters employed in high-energy physics. This paper results from a project motivated by the development of the CMS calorimeter at CERN, which will make use of a large number of scintillating crystals. In order to prevent crystals from breaking because of internal residual stress, a quality control system based on optic inspection of interference fringe patterns was developed. The principle of measurement procedures was theoretically modelled, and then a dedicated polariscope was designed and built, in order to observe the crystals under induced stresses or to evaluate the residual internal stresses. The results are innovative and open a new perspective for scintillating crystals quality control: the photoelastic constant normal to the optic axis of the lead tungstate crystals (PbWO 4) was measured, and the inspection procedure developed is applicable to mass production, not only to optimize the crystal processing, but also to establish a quality inspection procedure.

40 CFR 96.172 - Out of control periods.

Code of Federal Regulations, 2013 CFR

2013-07-01

... the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or... Administrator revokes prospectively the certification status of the monitoring system. The data measured and...

40 CFR 96.172 - Out of control periods.

Code of Federal Regulations, 2012 CFR

2012-07-01

... the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or... Administrator revokes prospectively the certification status of the monitoring system. The data measured and...

40 CFR 96.172 - Out of control periods.

Code of Federal Regulations, 2011 CFR

2011-07-01

... the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or... Administrator revokes prospectively the certification status of the monitoring system. The data measured and...

40 CFR 96.172 - Out of control periods.

Code of Federal Regulations, 2010 CFR

2010-07-01

... the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or... Administrator revokes prospectively the certification status of the monitoring system. The data measured and...

40 CFR 96.172 - Out of control periods.

Code of Federal Regulations, 2014 CFR

2014-07-01

... the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or... Administrator revokes prospectively the certification status of the monitoring system. The data measured and...

40 CFR 96.372 - Out of control periods.

Code of Federal Regulations, 2012 CFR

2012-07-01

... the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or... the Administrator revokes prospectively the certification status of the monitoring system. The data...

40 CFR 96.372 - Out of control periods.

Code of Federal Regulations, 2013 CFR

2013-07-01

... the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or... the Administrator revokes prospectively the certification status of the monitoring system. The data...

40 CFR 96.372 - Out of control periods.

Code of Federal Regulations, 2014 CFR

2014-07-01

... the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or... the Administrator revokes prospectively the certification status of the monitoring system. The data...

40 CFR 96.372 - Out of control periods.

Code of Federal Regulations, 2011 CFR

2011-07-01

... the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or... the Administrator revokes prospectively the certification status of the monitoring system. The data...

40 CFR 96.372 - Out of control periods.

Code of Federal Regulations, 2010 CFR

2010-07-01

... the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or... the Administrator revokes prospectively the certification status of the monitoring system. The data...

21 CFR 107.50 - Terms and conditions.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Center for Food Safety and Applied Nutrition concludes that additional or modified quality control... also typically represented and labeled for use to provide dietary management for diseases or conditions... regulations promulgated under section 412(a)(2) of the act, the quality control procedure requirements of part...

Assessment of in-situ test technology for construction control of base courses and embankments.

DOT National Transportation Integrated Search

2004-05-01

With the coming move from an empirical to mechanistic-empirical pavement design, it is essential to improve the quality control/quality assurance (QC/QA) procedures of compacted materials from a density-based criterion to a stiffness/strength-based c...

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...

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.

Quality-assurance plan for the analysis of fluvial sediment by laboratories of the U.S. Geological Survey

USGS Publications Warehouse

Matthes, Wilbur J.; Sholar, Clyde J.; George, John R.

1992-01-01

This report describes procedures used by the Iowa District sediment laboratory of the U.S. Geological Survey to assure the quality of sediment-laboratory data. These procedures can be used by other U.S. Geological Survey laboratories regardless of size and type of operation for quality assurance and quality control of specific sediment-laboratory processes. Also described are the equipment, specifications, calibration and maintenance, and the protocol for methods used in the analyses of fluvial sediment for concentration or particle size.

Control by quality: proposition of a typology.

PubMed

Pujo, P; Pillet, M

The application of Quality tools and methods in industrial management has always had a fundamental impact on the control of production. It influences the behavior of the actors concerned, while introducing the necessary notions and formalizations, especially for production systems with little or no automation, which constitute a large part of the industrial activity. Several quality approaches are applied in the workshop and are implemented at the level of the control. In this paper, the authors present a typology of the various approaches that have successively influenced control, such as statistical process control, quality assurance, and continuous improvement. First the authors present a parallel between production control and quality organizational structure. They note the duality between control, which is aimed at increasing productivity, and quality, which aims to satisfy the needs of the customer. They also note the hierarchical organizational structure of these two systems of management with, at each level, the notion of a feedback loop. This notion is fundamental to any kind of decision making. The paper is organized around the operational, tactical, and strategic levels, by describing for each level the main methods and tools for control by quality. The overview of these tools and methods starts at the operational level, with the Statistical Process Control, the Taguchi technique, and the "six sigma" approach. On the tactical level, we find a quality system approach, with a documented description of the procedures introduced in the firm. The management system can refer here to Quality Assurance, Total Productive Maintenance, or Management by Total Quality. The formalization through procedures of the rules of decision governing the process control enhances the validity of these rules. This leads to the enhancement of their reliability and to their consolidation. All this counterbalances the human, intrinsically fluctuating, behavior of the control operators. Strategic control by quality is then detailed, and the two main approaches, the continuous improvement approach and the proactive improvement approach, are introduced. Finally, the authors observe that at each of the three levels, the continuous process improvement, which is a component of Total Quality, becomes an essential preoccupation for the control. Ultimately, the recursive utilization of the Deming cycle remains the best practice for the control by quality.

21 CFR 225.65 - Equipment cleanout procedures.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Product Quality Control § 225.65 Equipment cleanout procedures. (a) Adequate cleanout procedures for all equipment used in the manufacture... sequential production of feeds. (2) If flushing is utilized, the flush material shall be properly identified...

Use of Six Sigma Worksheets for assessment of internal and external failure costs associated with candidate quality control rules for an ADVIA 120 hematology analyzer.

PubMed

Cian, Francesco; Villiers, Elisabeth; Archer, Joy; Pitorri, Francesca; Freeman, Kathleen

2014-06-01

Quality control (QC) validation is an essential tool in total quality management of a veterinary clinical pathology laboratory. Cost-analysis can be a valuable technique to help identify an appropriate QC procedure for the laboratory, although this has never been reported in veterinary medicine. The aim of this study was to determine the applicability of the Six Sigma Quality Cost Worksheets in the evaluation of possible candidate QC rules identified by QC validation. Three months of internal QC records were analyzed. EZ Rules 3 software was used to evaluate candidate QC procedures, and the costs associated with the application of different QC rules were calculated using the Six Sigma Quality Cost Worksheets. The costs associated with the current and the candidate QC rules were compared, and the amount of cost savings was calculated. There was a significant saving when the candidate 1-2.5s, n = 3 rule was applied instead of the currently utilized 1-2s, n = 3 rule. The savings were 75% per year (£ 8232.5) based on re-evaluating all of the patient samples in addition to the controls, and 72% per year (£ 822.4) based on re-analyzing only the control materials. The savings were also shown to change accordingly with the number of samples analyzed and with the number of daily QC procedures performed. These calculations demonstrated the importance of the selection of an appropriate QC procedure, and the usefulness of the Six Sigma Costs Worksheet in determining the most cost-effective rule(s) when several candidate rules are identified by QC validation. © 2014 American Society for Veterinary Clinical Pathology and European Society for Veterinary Clinical Pathology.

U.S.-MEXICO BORDER PROGRAM ARIZONA BORDER STUDY--STANDARD OPERATING PROCEDURE FOR FORM QA AND QC CHECKS (UA-C-2.0)

EPA Science Inventory

The purpose of this SOP is to outline the process of field quality assurance and quality control checks. This procedure was followed to ensure consistent data retrieval during the Arizona NHEXAS project and the Border study. Keywords: custody; QA/QC; field checks.

The U.S.-Mex...

The European general thoracic surgery database project.

PubMed

Falcoz, Pierre Emmanuel; Brunelli, Alessandro

2014-05-01

The European Society of Thoracic Surgeons (ESTS) Database is a free registry created by ESTS in 2001. The current online version was launched in 2007. It runs currently on a Dendrite platform with extensive data security and frequent backups. The main features are a specialty-specific, procedure-specific, prospectively maintained, periodically audited and web-based electronic database, designed for quality control and performance monitoring, which allows for the collection of all general thoracic procedures. Data collection is the "backbone" of the ESTS database. It includes many risk factors, processes of care and outcomes, which are specially designed for quality control and performance audit. The user can download and export their own data and use them for internal analyses and quality control audits. The ESTS database represents the gold standard of clinical data collection for European General Thoracic Surgery. Over the past years, the ESTS database has achieved many accomplishments. In particular, the database hit two major milestones: it now includes more than 235 participating centers and 70,000 surgical procedures. The ESTS database is a snapshot of surgical practice that aims at improving patient care. In other words, data capture should become integral to routine patient care, with the final objective of improving quality of care within Europe.

Enhanced job control language procedures for the SIMSYS2D two-dimensional water-quality simulation system

USGS Publications Warehouse

Karavitis, G.A.

1984-01-01

The SIMSYS2D two-dimensional water-quality simulation system is a large-scale digital modeling software system used to simulate flow and transport of solutes in freshwater and estuarine environments. Due to the size, processing requirements, and complexity of the system, there is a need to easily move the system and its associated files between computer sites when required. A series of job control language (JCL) procedures was written to allow transferability between IBM and IBM-compatible computers. (USGS)

38 CFR 36.4348 - Servicer Appraisal Processing Program.

Code of Federal Regulations, 2012 CFR

2012-07-01

... requirement, routine reviews of SAPP cases will be made by VA staff based upon quality control procedures..., that its activities do not deviate from high standards of integrity. The quality control system must include frequent, periodic audits that specifically address the appraisal review activity. These audits...

38 CFR 36.4348 - Servicer Appraisal Processing Program.

Code of Federal Regulations, 2014 CFR

2014-07-01

... requirement, routine reviews of SAPP cases will be made by VA staff based upon quality control procedures..., that its activities do not deviate from high standards of integrity. The quality control system must include frequent, periodic audits that specifically address the appraisal review activity. These audits...

38 CFR 36.4348 - Servicer Appraisal Processing Program.

Code of Federal Regulations, 2013 CFR

2013-07-01

... requirement, routine reviews of SAPP cases will be made by VA staff based upon quality control procedures..., that its activities do not deviate from high standards of integrity. The quality control system must include frequent, periodic audits that specifically address the appraisal review activity. These audits...

38 CFR 36.4348 - Servicer Appraisal Processing Program.

Code of Federal Regulations, 2011 CFR

2011-07-01

... requirement, routine reviews of SAPP cases will be made by VA staff based upon quality control procedures..., that its activities do not deviate from high standards of integrity. The quality control system must include frequent, periodic audits that specifically address the appraisal review activity. These audits...

40 CFR 96.272 - Out of control periods.

Code of Federal Regulations, 2011 CFR

2011-07-01

... the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D of or... prospectively the certification status of the monitoring system. The data measured and recorded by the...

40 CFR 96.272 - Out of control periods.

Code of Federal Regulations, 2012 CFR

2012-07-01

... the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D of or... prospectively the certification status of the monitoring system. The data measured and recorded by the...

40 CFR 96.272 - Out of control periods.

Code of Federal Regulations, 2014 CFR

2014-07-01

... the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D of or... prospectively the certification status of the monitoring system. The data measured and recorded by the...

40 CFR 96.272 - Out of control periods.

Code of Federal Regulations, 2010 CFR

2010-07-01

... the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D of or... prospectively the certification status of the monitoring system. The data measured and recorded by the...

40 CFR 96.272 - Out of control periods.

Code of Federal Regulations, 2013 CFR

2013-07-01

... the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D of or... prospectively the certification status of the monitoring system. The data measured and recorded by the...

[Evaluation of quality of HIV diagnostic procedures in Poland].

PubMed

Parczewski, Miłosz; Madaliński, Kazimierz; Leszczyszyn-Pynka, Magdalena; Boroń-Kaczmarska, Anna

2010-01-01

The aim of this work was quality assessment of HIV diagnostic procedures in Poland, including human and technical resources as well as laboratory practice. Sixty questionnaires were distributed among diagnostic centers to obtain qualitative data. Basing on the survey data serological control using coded panels of HIV-1/2 samples was performed. Thirty-one filled questionnaires were received (50.8%). Surveyed laboratories perform from 350 to 5500 serological screening tests per year. In most of laboratories fourth generation assays are available, while Blood Donation Centers screen the blood both with serological assays and by HIV-RNA detection. Sanitary and Epidemiological Stations and academic laboratories hold the ISO/IEC 17025 or IS0 9001:2001 accreditation, five of the surveyed centers participate in Labquality assurance and two in Quality Control in Molecular Diagnostics programs. Data of control serological testing were received from 21 centers. In the quality control assessment 194 analyses were performed with 91 true negative, 2 false negative, 96 true positive and 5 false positive results. False negative rate of % and false positive rate of 5.2% was noted for this study. Currently, virtually no guidelines related to the HIV-diagnostics quality assurance and control in Poland are in delineated. Development of the national unified quality control system, basing on the central institution is highly desirable. National certification within the frames of the quality control and assurance program should be mandatory for all the diagnostic labs, and aim at improvement of reliability of the result distributed among clinicians and patients.

Quality control in diagnostic immunohistochemistry: integrated on-slide positive controls.

PubMed

Bragoni, A; Gambella, A; Pigozzi, S; Grigolini, M; Fiocca, R; Mastracci, L; Grillo, F

2017-11-01

Standardization in immunohistochemistry is a priority in modern pathology and requires strict quality control. Cost containment has also become fundamental and auditing of all procedures must take into account both these principles. Positive controls must be routinely performed so that their positivity guarantees the appropriateness of the immunohistochemical procedure. The aim of this study is to develop a low cost (utilizing a punch biopsy-PB-tool) procedure to construct positive controls which can be integrated in the patient's tissue slide. Sixteen frequently used control blocks were selected and multiple cylindrical samples were obtained using a 5-mm diameter punch biopsy tool, separately re-embedding them in single blocks. For each diagnostic immunoreaction requiring a positive control, an integrated PB-control section (cut from the appropriate PB-control block) was added to the top right corner of the diagnostic slide before immunostaining. This integrated control technique permitted a saving of 4.75% in total direct lab costs and proved to be technically feasible and reliable. Our proposal is easy to perform and within the reach of all pathology labs, requires easily available tools, its application costs is less than using external paired controls and ensures that a specific control for each slide is always available.

The CRAC cohort model: A computerized low cost registry of interventional cardiology with daily update and long-term follow-up.

PubMed

Rangé, G; Chassaing, S; Marcollet, P; Saint-Étienne, C; Dequenne, P; Goralski, M; Bardiére, P; Beverilli, F; Godillon, L; Sabine, B; Laure, C; Gautier, S; Hakim, R; Albert, F; Angoulvant, D; Grammatico-Guillon, L

2018-05-01

To assess the reliability and low cost of a computerized interventional cardiology (IC) registry to prospectively and systematically collect high-quality data for all consecutive coronary patients referred for coronary angiogram or/and coronary angioplasty. Rigorous clinical practice assessment is a key factor to improve prognosis in IC. A prospective and permanent registry could achieve this goal but, presumably, at high cost and low level of data quality. One multicentric IC registry (CRAC registry), fully integrated to usual coronary activity report software, started in the centre Val-de-Loire (CVL) French region in 2014. Quality assessment of CRAC registry was conducted on five IC CathLab of the CVL region, from January 1st to December 31st 2014. Quality of collected data was evaluated by measuring procedure exhaustivity (comparing with data from hospital information system), data completeness (quality controls) and data consistency (by checking complete medical charts as gold standard). Cost per procedure (global registry operating cost/number of collected procedures) was also estimated. CRAC model provided a high-quality level with 98.2% procedure completeness, 99.6% data completeness and 89% data consistency. The operating cost per procedure was €14.70 ($16.51) for data collection and quality control, including ST-segment elevation myocardial infarction (STEMI) preadmission information and one-year follow-up after angioplasty. This integrated computerized IC registry led to the construction of an exhaustive, reliable and costless database, including all coronary patients entering in participating IC centers in the CVL region. This solution will be developed in other French regions, setting up a national IC database for coronary patients in 2020: France PCI. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Quality control and assurance for validation of DOS/I measurements

NASA Astrophysics Data System (ADS)

Cerussi, Albert; Durkin, Amanda; Kwong, Richard; Quang, Timothy; Hill, Brian; Tromberg, Bruce J.; MacKinnon, Nick; Mantulin, William W.

2010-02-01

Ongoing multi-center clinical trials are crucial for Biophotonics to gain acceptance in medical imaging. In these trials, quality control (QC) and assurance (QA) are key to success and provide "data insurance". Quality control and assurance deal with standardization, validation, and compliance of procedures, materials and instrumentation. Specifically, QC/QA involves systematic assessment of testing materials, instrumentation performance, standard operating procedures, data logging, analysis, and reporting. QC and QA are important for FDA accreditation and acceptance by the clinical community. Our Biophotonics research in the Network for Translational Research in Optical Imaging (NTROI) program for breast cancer characterization focuses on QA/QC issues primarily related to the broadband Diffuse Optical Spectroscopy and Imaging (DOS/I) instrumentation, because this is an emerging technology with limited standardized QC/QA in place. In the multi-center trial environment, we implement QA/QC procedures: 1. Standardize and validate calibration standards and procedures. (DOS/I technology requires both frequency domain and spectral calibration procedures using tissue simulating phantoms and reflectance standards, respectively.) 2. Standardize and validate data acquisition, processing and visualization (optimize instrument software-EZDOS; centralize data processing) 3. Monitor, catalog and maintain instrument performance (document performance; modularize maintenance; integrate new technology) 4. Standardize and coordinate trial data entry (from individual sites) into centralized database 5. Monitor, audit and communicate all research procedures (database, teleconferences, training sessions) between participants ensuring "calibration". This manuscript describes our ongoing efforts, successes and challenges implementing these strategies.

10 CFR 32.110 - Acceptance sampling procedures under certain specific licenses.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Acceptance sampling procedures under certain specific licenses. 32.110 Section 32.110 Energy NUCLEAR REGULATORY COMMISSION SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL Quality Control Sampling Procedures § 32...

10 CFR 32.110 - Acceptance sampling procedures under certain specific licenses.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Acceptance sampling procedures under certain specific licenses. 32.110 Section 32.110 Energy NUCLEAR REGULATORY COMMISSION SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL Quality Control Sampling Procedures § 32...

Design and development of polyphenylene oxide foam as a reusable internal insulation for LH2 tanks

NASA Technical Reports Server (NTRS)

1975-01-01

Material specification and fabrication process procedures for foam production are presented. The properties of mechanical strength, modulus of elasticity, density and thermal conductivity were measured and related to foam quality. Properties unique to the foam such as a gas layer insulation, density gradient parallel to the fiber direction, and gas flow conductance in both directions were correlated with foam quality. Inspection and quality control tests procedures are outlined and photographs of test equipment and test specimens are shown.

40 CFR 97.632 - Monitoring system out-of-control periods.

Code of Federal Regulations, 2014 CFR

2014-07-01

.... Whenever any monitoring system fails to meet the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or appendix D to part 75 of this chapter. (b) Audit decertification...

40 CFR 97.432 - Monitoring system out-of-control periods.

Code of Federal Regulations, 2013 CFR

2013-07-01

... monitoring system fails to meet the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures... prospectively the certification status of the monitoring system. The data measured and recorded by the...

40 CFR 97.732 - Monitoring system out-of-control periods.

Code of Federal Regulations, 2013 CFR

2013-07-01

.... Whenever any monitoring system fails to meet the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or appendix D to part 75 of this chapter. (b) Audit decertification...

40 CFR 97.432 - Monitoring system out-of-control periods.

Code of Federal Regulations, 2014 CFR

2014-07-01

... monitoring system fails to meet the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures... prospectively the certification status of the monitoring system. The data measured and recorded by the...

40 CFR 60.4172 - Out of control periods.

Code of Federal Regulations, 2011 CFR

2011-07-01

... monitoring system fails to meet the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures... certification status of the monitoring system. The data measured and recorded by the monitoring system shall not...

40 CFR 97.432 - Monitoring system out-of-control periods.

Code of Federal Regulations, 2012 CFR

2012-07-01

... monitoring system fails to meet the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures... prospectively the certification status of the monitoring system. The data measured and recorded by the...

40 CFR 97.632 - Monitoring system out-of-control periods.

Code of Federal Regulations, 2013 CFR

2013-07-01

.... Whenever any monitoring system fails to meet the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or appendix D to part 75 of this chapter. (b) Audit decertification...

40 CFR 60.4172 - Out of control periods.

Code of Federal Regulations, 2010 CFR

2010-07-01

... monitoring system fails to meet the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures... certification status of the monitoring system. The data measured and recorded by the monitoring system shall not...

40 CFR 97.732 - Monitoring system out-of-control periods.

Code of Federal Regulations, 2012 CFR

2012-07-01

.... Whenever any monitoring system fails to meet the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or appendix D to part 75 of this chapter. (b) Audit decertification...

40 CFR 97.632 - Monitoring system out-of-control periods.

Code of Federal Regulations, 2012 CFR

2012-07-01

.... Whenever any monitoring system fails to meet the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or appendix D to part 75 of this chapter. (b) Audit decertification...

40 CFR 97.732 - Monitoring system out-of-control periods.

Code of Federal Regulations, 2014 CFR

2014-07-01

.... Whenever any monitoring system fails to meet the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or appendix D to part 75 of this chapter. (b) Audit decertification...

Development of models to estimate the subgrade and subbase layers' resilient modulus from in situ devices test results for construction control.

DOT National Transportation Integrated Search

2008-04-01

The objective of this study was to develop resilient modulus prediction models for possible application in the quality control/quality assurance (QC/QA) procedures during and after the construction of pavement layers. Field and laboratory testing pro...

33 CFR 385.21 - Quality control.

Code of Federal Regulations, 2014 CFR

2014-07-01

... will be produced by a Project Delivery Team. The quality control plan shall be included in the Project Management Plan and shall describe the procedures to be used to ensure compliance with technical and policy requirements during implementation. (b) During development of the Project Management Plan for each project, the...

21 CFR 1000.55 - Recommendation for quality assurance programs in diagnostic radiology facilities.

Code of Federal Regulations, 2010 CFR

2010-04-01

... components of an x-ray system. The quality control techniques thus are concerned directly with the equipment... in response to monitoring results. These procedures provide the organizational framework for the... control, a tube-housing assembly, a beam-limiting device, and the necessary supporting structures. Other...

Multi-Site Quality Assurance Project Plan for Wisconsin Public Service Corporation, Peoples Gas Light and Coke Company, and North Shore Gas

EPA Pesticide Factsheets

This Multi-Site QAPP presents the organization, data quality objectives (DQOs), a set of anticipated activities, sample analysis, data handling and specific Quality Assurance/Quality Control (QA/QC) procedures associated with Studies done in EPA Region 5

Quality controls for wind measurement of a 1290-MHz boundary layer profiler under strong wind conditions.

PubMed

Liu, Zhao; Zheng, Chaorong; Wu, Yue

2017-09-01

Wind profilers have been widely adopted to observe the wind field information in the atmosphere for different purposes. But accuracy of its observation has limitations due to various noises or disturbances and hence need to be further improved. In this paper, the data measured under strong wind conditions, using a 1290-MHz boundary layer profiler (BLP), are quality controlled via a composite quality control (QC) procedure proposed by the authors. Then, through the comparison with the data measured by radiosonde flights (balloon observations), the critical thresholds in the composite QC procedure, including consensus average threshold T 1 and vertical shear threshold T 3 , are systematically discussed. And the performance of the BLP operated under precipitation is also evaluated. It is found that to ensure the high accuracy and high data collectable rate, the optimal range of subsets is determined to be 4 m/s. Although the number of data rejected by the combined algorithm of vertical shear examination and small median test is quite limited, it is proved that the algorithm is quite useful to recognize the outlier with a large discrepancy. And the optimal wind shear threshold T 3 can be recommended as 5 ms -1 /100m. During patchy precipitation, the quality of data measured by the four oblique beams (using the DBS measuring technique) can still be ensured. After the BLP data are quality controlled by the composite QC procedure, the output can show good agreement with the balloon observation.

Cumulative uncertainty in measured streamflow and water quality data for small watersheds

USGS Publications Warehouse

Harmel, R.D.; Cooper, R.J.; Slade, R.M.; Haney, R.L.; Arnold, J.G.

2006-01-01

The scientific community has not established an adequate understanding of the uncertainty inherent in measured water quality data, which is introduced by four procedural categories: streamflow measurement, sample collection, sample preservation/storage, and laboratory analysis. Although previous research has produced valuable information on relative differences in procedures within these categories, little information is available that compares the procedural categories or presents the cumulative uncertainty in resulting water quality data. As a result, quality control emphasis is often misdirected, and data uncertainty is typically either ignored or accounted for with an arbitrary margin of safety. Faced with the need for scientifically defensible estimates of data uncertainty to support water resource management, the objectives of this research were to: (1) compile selected published information on uncertainty related to measured streamflow and water quality data for small watersheds, (2) use a root mean square error propagation method to compare the uncertainty introduced by each procedural category, and (3) use the error propagation method to determine the cumulative probable uncertainty in measured streamflow, sediment, and nutrient data. Best case, typical, and worst case "data quality" scenarios were examined. Averaged across all constituents, the calculated cumulative probable uncertainty (??%) contributed under typical scenarios ranged from 6% to 19% for streamflow measurement, from 4% to 48% for sample collection, from 2% to 16% for sample preservation/storage, and from 5% to 21% for laboratory analysis. Under typical conditions, errors in storm loads ranged from 8% to 104% for dissolved nutrients, from 8% to 110% for total N and P, and from 7% to 53% for TSS. Results indicated that uncertainty can increase substantially under poor measurement conditions and limited quality control effort. This research provides introductory scientific estimates of uncertainty in measured water quality data. The results and procedures presented should also assist modelers in quantifying the "quality"of calibration and evaluation data sets, determining model accuracy goals, and evaluating model performance.

Analytical procedure validation and the quality by design paradigm.

PubMed

Rozet, Eric; Lebrun, Pierre; Michiels, Jean-François; Sondag, Perceval; Scherder, Tara; Boulanger, Bruno

2015-01-01

Since the adoption of the ICH Q8 document concerning the development of pharmaceutical processes following a quality by design (QbD) approach, there have been many discussions on the opportunity for analytical procedure developments to follow a similar approach. While development and optimization of analytical procedure following QbD principles have been largely discussed and described, the place of analytical procedure validation in this framework has not been clarified. This article aims at showing that analytical procedure validation is fully integrated into the QbD paradigm and is an essential step in developing analytical procedures that are effectively fit for purpose. Adequate statistical methodologies have also their role to play: such as design of experiments, statistical modeling, and probabilistic statements. The outcome of analytical procedure validation is also an analytical procedure design space, and from it, control strategy can be set.

High-throughput biomonitoring of dioxins and polychlorinated biphenyls at the sub-picogram level in human serum.

PubMed

Focant, Jean-François; Eppe, Gauthier; Massart, Anne-Cécile; Scholl, Georges; Pirard, Catherine; De Pauw, Edwin

2006-10-13

We report on the use of a state-of-the-art method for the measurement of selected polychlorinated dibenzo-p-dioxins, polychlorinated dibenzofurans and polychlorinated biphenyls in human serum specimens. The sample preparation procedure is based on manual small size solid-phase extraction (SPE) followed by automated clean-up and fractionation using multi-sorbent liquid chromatography columns. SPE cartridges and all clean-up columns are disposable. Samples are processed in batches of 20 units, including one blank control (BC) sample and one quality control (QC) sample. The analytical measurement is performed using gas chromatography coupled to isotope dilution high-resolution mass spectrometry. The sample throughput corresponds to one series of 20 samples per day, from sample reception to data quality cross-check and reporting, once the procedure has been started and series of samples keep being produced. Four analysts are required to ensure proper performances of the procedure. The entire procedure has been validated under International Organization for Standardization (ISO) 17025 criteria and further tested over more than 1500 unknown samples during various epidemiological studies. The method is further discussed in terms of reproducibility, efficiency and long-term stability regarding the 35 target analytes. Data related to quality control and limit of quantification (LOQ) calculations are also presented and discussed.

[Testing of medicinal products produced from pooled plasma].

PubMed

Unkelbach, U; Hunfeld, A; Breitner-Ruddock, S

2014-10-01

Medicinal products produced from human plasma fall under the administrative batch release procedure of the competent authority. In Germany, this has been carried out since 1995 by the Paul Ehrlich Institute (PEI), the responsible state control agency for blood products. Medicinal products released for the European and national market are tested for quality, efficacy and safety. Experimental testing of the final product and the starting materials, the plasma pools, as well as control of the production documentation guarantee a constantly high product safety. In the 28,000 batches tested since the beginning of the state controlled batch release testing of these blood products at the PEI, there has been no transmission of infectious viruses (HIV, HBV and HCV) to any patient. The batch release has made a contribution to the improvement of product quality. This procedure is still an important tool to ensure safety of blood products. The PEI is integrated in the batch release network of the European Directorate for the Quality of Medicines & Health Care (EDQM) in Strasbourg. Regulations and guidelines for official control authority batch release (OCABR) ensure harmonized procedures for mutual recognition of batch release on the European level. The EU certificates and German national certificates are requested and accepted in over 70 countries worldwide. Experimental testing in the EU and the requisite certificates have developed into a seal of quality for the world market.

Design and implementation of software for automated quality control and data analysis for a complex LC/MS/MS assay for urine opiates and metabolites.

PubMed

Dickerson, Jane A; Schmeling, Michael; Hoofnagle, Andrew N; Hoffman, Noah G

2013-01-16

Mass spectrometry provides a powerful platform for performing quantitative, multiplexed assays in the clinical laboratory, but at the cost of increased complexity of analysis and quality assurance calculations compared to other methodologies. Here we describe the design and implementation of a software application that performs quality control calculations for a complex, multiplexed, mass spectrometric analysis of opioids and opioid metabolites. The development and implementation of this application improved our data analysis and quality assurance processes in several ways. First, use of the software significantly improved the procedural consistency for performing quality control calculations. Second, it reduced the amount of time technologists spent preparing and reviewing the data, saving on average over four hours per run, and in some cases improving turnaround time by a day. Third, it provides a mechanism for coupling procedural and software changes with the results of each analysis. We describe several key details of the implementation including the use of version control software and automated unit tests. These generally useful software engineering principles should be considered for any software development project in the clinical lab. Copyright © 2012 Elsevier B.V. All rights reserved.

Flight Evaluation Procedures and Quality Control of Training. Technical Report 68-3.

ERIC Educational Resources Information Center

Caro, Paul W., Jr.

Research at the United States Army Aviation School, Fort Rucker, Alabama, sought to improve the school-wide training quality control system. Investigators studied: 1) the relation between the grades a student received from instructors and those he received from a checkpilot; 2) the effect of checkpilots' prior information about students' progress…

40 CFR 97.532 - Monitoring system out-of-control periods.

Code of Federal Regulations, 2012 CFR

2012-07-01

.... Whenever any monitoring system fails to meet the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or subpart H of, or appendix D or appendix E to, part 75 of this chapter...

40 CFR 97.532 - Monitoring system out-of-control periods.

Code of Federal Regulations, 2014 CFR

2014-07-01

.... Whenever any monitoring system fails to meet the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or subpart H of, or appendix D or appendix E to, part 75 of this chapter...

40 CFR 97.532 - Monitoring system out-of-control periods.

Code of Federal Regulations, 2013 CFR

2013-07-01

.... Whenever any monitoring system fails to meet the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or subpart H of, or appendix D or appendix E to, part 75 of this chapter...

21 CFR 111.140 - Under this subpart F, what records must you make and keep?

Code of Federal Regulations, 2010 CFR

2010-04-01

... and making a disposition decision and written procedures for approving or rejecting any reprocessing... perform the quality control operation, who conducted the material review and made the disposition decision... System: Requirements for Quality Control § 111.140 Under this subpart F, what records must you make and...

A Framework for a Quality Control System for Vendor/Processor Contracts.

ERIC Educational Resources Information Center

Advanced Technology, Inc., Reston, VA.

A framework for monitoring quality control (QC) of processor contracts administered by the Department of Education's Office of Student Financial Assistance (OSFA) is presented and applied to the Pell Grant program. Guidelines for establishing QC measures and standards are included, and the uses of a sampling procedure in the QC system are…

MO-A-16A-01: QA Procedures and Metrics: In Search of QA Usability

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

Sathiaseelan, V; Thomadsen, B

Radiation therapy has undergone considerable changes in the past two decades with a surge of new technology and treatment delivery methods. The complexity of radiation therapy treatments has increased and there has been increased awareness and publicity about the associated risks. In response, there has been proliferation of guidelines for medical physicists to adopt to ensure that treatments are delivered safely. Task Group recommendations are copious, and clinical physicists' hours are longer, stretched to various degrees between site planning and management, IT support, physics QA, and treatment planning responsibilities.Radiation oncology has many quality control practices in place to ensure themore » delivery of high-quality, safe treatments. Incident reporting systems have been developed to collect statistics about near miss events at many radiation oncology centers. However, tools are lacking to assess the impact of these various control measures. A recent effort to address this shortcoming is the work of Ford et al (2012) who recently published a methodology enumerating quality control quantification for measuring the effectiveness of safety barriers. Over 4000 near-miss incidents reported from 2 academic radiation oncology clinics were analyzed using quality control quantification, and a profile of the most effective quality control measures (metrics) was identified.There is a critical need to identify a QA metric to help the busy clinical physicists to focus their limited time and resources most effectively in order to minimize or eliminate errors in the radiation treatment delivery processes. In this symposium the usefulness of workflows and QA metrics to assure safe and high quality patient care will be explored.Two presentations will be given:Quality Metrics and Risk Management with High Risk Radiation Oncology ProceduresStrategies and metrics for quality management in the TG-100 Era Learning Objectives: Provide an overview and the need for QA usability metrics: Different cultures/practices affecting the effectiveness of methods and metrics. Show examples of quality assurance workflows, Statistical process control, that monitor the treatment planning and delivery process to identify errors. To learn to identify and prioritize risks and QA procedures in radiation oncology. Try to answer the question: Can a quality assurance program aided by quality assurance metrics help minimize errors and ensure safe treatment delivery. Should such metrics be institution specific.« less

Real-time control of combined surface water quantity and quality: polder flushing.

PubMed

Xu, M; van Overloop, P J; van de Giesen, N C; Stelling, G S

2010-01-01

In open water systems, keeping both water depths and water quality at specified values is critical for maintaining a 'healthy' water system. Many systems still require manual operation, at least for water quality management. When applying real-time control, both quantity and quality standards need to be met. In this paper, an artificial polder flushing case is studied. Model Predictive Control (MPC) is developed to control the system. In addition to MPC, a 'forward estimation' procedure is used to acquire water quality predictions for the simplified model used in MPC optimization. In order to illustrate the advantages of MPC, classical control [Proportional-Integral control (PI)] has been developed for comparison in the test case. The results show that both algorithms are able to control the polder flushing process, but MPC is more efficient in functionality and control flexibility.

[Compatibility of different quality control systems].

PubMed

Invernizzi, Enrico

2002-01-01

Management of the good laboratory practice (GLP) quality system presupposes its linking to a basic recognized and approved quality system, from which it can draw on management procedures common to all quality systems, such as the ISO 9000 set of norms. A quality system organized in this way can also be integrated with other dedicated quality systems, or parts of them, to obtain principles or management procedures for specific topics. The aim of this organization is to set up a reliable, recognized quality system compatible with the principles of GLP and other quality management systems, which provides users with a simplified set of easily accessible management tools and answers. The organization of this quality system is set out in the quality assurance programme, which is actually the document in which the test facility incorporates the GLP principles into its own quality organization.

Review of indicators for cross-sectoral optimization of nosocomial infection prophylaxis – a perspective from structurally- and process-oriented hygiene

PubMed Central

Hübner, Nils-Olaf; Fleßa, Steffen; Jakisch, Ralf; Assadian, Ojan; Kramer, Axel

2012-01-01

In the care of patients, the prevention of nosocomial infections is crucial. For it to be successful, cross-sectoral, interface-oriented hygiene quality management is necessary. The goal is to apply the HACCP (Hazard Assessment and Critical Control Points) concept to hospital hygiene, in order to create a multi-dimensional hygiene control system based on hygiene indicators that will overcome the limitations of a procedurally non-integrated and non-cross-sectoral view of hygiene. Three critical risk dimensions can be identified for the implementation of three-dimensional quality control of hygiene in clinical routine: the constitution of the person concerned, the surrounding physical structures and technical equipment, and the medical procedures. In these dimensions, the establishment of indicators and threshold values enables a comprehensive assessment of hygiene quality. Thus, the cross-sectoral evaluation of the quality of structure, processes and results is decisive for the success of integrated infection prophylaxis. This study lays the foundation for hygiene indicator requirements and develops initial concepts for evaluating quality management in hygiene. PMID:22558049

The medical practice of euthanasia in Belgium and The Netherlands: legal notification, control and evaluation procedures.

PubMed

Smets, Tinne; Bilsen, Johan; Cohen, Joachim; Rurup, Mette L; De Keyser, Els; Deliens, Luc

2009-05-01

To describe and compare current legal procedures for notifying, controlling and evaluating (NCE-procedures) euthanasia in Belgium and the Netherlands, and to discuss the implications for a safe and controllable euthanasia practice. We systematically studied and compared official documents relating to the Belgian and the Dutch NCE-procedures for euthanasia. In both countries, physicians are required to notify their cases to a review Committee, stimulating them to safeguard the quality of their euthanasia practice and to make societal control over the practice of euthanasia possible. However, the procedures in both countries differ. The main differences are that the Dutch notification and control procedures are more elaborate and transparent than the Belgian, and that the Belgian procedures are primarily anonymous, whereas the Dutch are not. Societal evaluation is made in both countries through the Committees' summary reports to Parliament. Transparent procedures like the Dutch may better facilitate societal control. Informing physicians about the law and the due care requirements for euthanasia, and systematic feedback about their medical actions are both pivotal to achieving efficient societal control and engendering the level of care needed when performing such far-reaching medical acts.

Current standards for infection control: audit assures compliance.

PubMed

Flanagan, Pauline

Having robust policies and procedures in place for infection control is fundamentally important. However, each organization has to go a step beyond this; evidence has to be provided that these policies and procedures are followed. As of 1 April 2009, with the introduction of the Care Quality Commission and The Health and Social Care Act 2008 Code of Practice for the NHS on the Prevention and Control of Healthcare-Associated Infections and Related Guidance, the assurance of robust infection control measures within any UK provider of health care became an even higher priority. Also, the commissioning of any service by the NHS must provide evidence that the provider has in place robust procedures for infection control. This article demonstrates how the clinical audit team at the Douglas Macmillan Hospice in North Staffordshire, UK, have used audit to assure high rates of compliance with the current national standards for infection control. Prior to the audit, hospice staff had assumed that the rates of compliance for infection control approached 100%. This article shows that a good quality audit tool can be used to identify areas of shortfall in infection control and the effectiveness of putting in place an action plan followed by re-audit.

42 CFR 423.171 - Procedures for approval of accreditation as a basis for deeming compliance.

Code of Federal Regulations, 2010 CFR

2010-10-01

... BENEFIT Cost Control and Quality Improvement Requirements § 423.171 Procedures for approval of... 42 Public Health 3 2010-10-01 2010-10-01 false Procedures for approval of accreditation as a basis for deeming compliance. 423.171 Section 423.171 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES...

NHEXAS PHASE I ARIZONA STUDY--STANDARD OPERATING PROCEDURE FOR PREPARATION OF STANDARD OPERATING PROCEDURES (SOPS) (UA-G-1.0)

EPA Science Inventory

The purpose of this SOP is to establish a uniform format for the preparation of SOPs. Use of these protocols ensures consistent implementation of project tasks, documents the preparation and implementation of the procedures used, describes quality control measures and the limits...

A New Quality Control Method base on IRMCD for Wind Profiler Observation towards Future Assimilation Application

NASA Astrophysics Data System (ADS)

Chen, Min; Zhang, Yu

2017-04-01

A wind profiler network with a total of 65 profiling radars was operated by the MOC/CMA in China until July 2015. In this study, a quality control procedure is constructed to incorporate the profiler data from the wind-profiling network into the local data assimilation and forecasting system (BJRUC). The procedure applies a blacklisting check that removes stations with gross errors and an outlier check that rejects data with large deviations from the background. Instead of the bi-weighting method, which has been commonly implemented in outlier elimination for one-dimensional scalar observations, an outlier elimination method is developed based on the iterated reweighted minimum covariance determinant (IRMCD) for multi-variate observations such as wind profiler data. A quality control experiment is separately performed for subsets containing profiler data tagged in parallel with/without rain flags at every 00UTC/12UTC from 20 June to 30 Sep 2015. From the results, we find that with the quality control, the frequency distributions of the differences between the observations and model background become more Gaussian-like and meet the requirements of a Gaussian distribution for data assimilation. Further intensive assessment for each quality control step reveals that the stations rejected by blacklisting contain poor data quality, and the IRMCD rejects outliers in a robust and physically reasonable manner.

Quality of radiotherapy reporting in randomized controlled trials of prostate cancer.

PubMed

Soon, Yu Yang; Chen, Desiree; Tan, Teng Hwee; Tey, Jeremy

2018-06-07

Good radiotherapy reporting in clinical trials of prostate radiotherapy is important because it will allow accurate reproducibility of radiotherapy treatment and minimize treatment variations that can affect patient outcomes. The aim of our study is to assess the quality of prostate radiotherapy (RT) treatment reporting in randomized controlled trials in prostate cancer. We searched MEDLINE for randomized trials of prostate cancer, published from 1996 to 2016 and included prostate RT as one of the intervention arms. We assessed if the investigators reported the ten criteria adequately in the trial reports: RT dose prescription method; RT dose-planning procedures; organs at risk (OAR) dose constraints; target volume definition, simulation procedures; treatment verification procedures; total RT dose; fractionation schedule; conduct of quality assurance (QA) as well as presence or absence of deviations in RT treatment planning and delivery. We performed multivariate logistic regression to determine the factors that may influence the quality of reporting. We found 59 eligible trials. There was significant variability in the quality of reporting. Target volume definition, total RT dose and fractionation schedule were reported adequately in 97% of included trials. OAR constraints, simulation procedures and presence or absence of deviations in RT treatment planning and delivery were reported adequately in 30% of included trials. Twenty-four trials (40%) reported seven criteria or more adequately. Multivariable logistic analysis showed that trials that published their quality assurance results and cooperative group trials were more likely to have adequate quality in reporting in at least seven criteria. There is significant variability in the quality of reporting on prostate radiotherapy treatment in randomized trials of prostate cancer. We need to have consensus guidelines to standardize the reporting of radiotherapy treatment in randomized trials.

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.

77 FR 56178 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-12

... programs. FSIS will use the PEPRL-F-0008-04 form as a self assessment audit checklist to collect information related to the quality assurance/quality control procedures in place at in-plant and private...

Guidelines for software inspections

NASA Technical Reports Server (NTRS)

1983-01-01

Quality control inspections are software problem finding procedures which provide defect removal as well as improvements in software functionality, maintenance, quality, and development and testing methodology is discussed. The many side benefits include education, documentation, training, and scheduling.

Quality Control for Interviews to Obtain Dietary Recalls from Children for Research Studies

PubMed Central

SHAFFER, NICOLE M.; THOMPSON, WILLIAM O.; BAGLIO, MICHELLE L.; GUINN, CAROLINE H.; FRYE, FRANCESCA H. A.

2005-01-01

Quality control is an important aspect of a study because the quality of data collected provides a foundation for the conclusions drawn from the study. For studies that include interviews, establishing quality control for interviews is critical in ascertaining whether interviews are conducted according to protocol. Despite the importance of quality control for interviews, few studies adequately document the quality control procedures used during data collection. This article reviews quality control for interviews and describes methods and results of quality control for interviews from two of our studies regarding the accuracy of children's dietary recalls; the focus is on quality control regarding interviewer performance during the interview, and examples are provided from studies with children. For our two studies, every interview was audio recorded and transcribed. The audio recording and typed transcript from one interview conducted by each research dietitian either weekly or daily were randomly selected and reviewed by another research dietitian, who completed a standardized quality control for interviews checklist. Major strengths of the methods of quality control for interviews in our two studies include: (a) interviews obtained for data collection were randomly selected for quality control for interviews, and (b) quality control for interviews was assessed on a regular basis throughout data collection. The methods of quality control for interviews described may help researchers design appropriate methods of quality control for interviews for future studies. PMID:15389417

Analysis of wind-tunnel stability and control tests in terms of flying qualities of full-scale airplanes

NASA Technical Reports Server (NTRS)

Kayten, Gerald G

1945-01-01

The analysis of results of wind-tunnel stability and control tests of powered airplane models in terms of the flying qualities of full-scale airplanes is advocated. In order to indicated the topics upon which comments are considered desirable in the report of a wind-tunnel stability and control investigation and to demonstrate the nature of the suggested analysis, the present NACA flying-qualities requirements are discussed in relation to wind-tunnel tests. General procedures for the estimation of flying qualities from wind-tunnel tests are outlined.

Assessing Subjectivity in Sensor Data Post Processing via a Controlled Experiment

NASA Astrophysics Data System (ADS)

Jones, A. S.; Horsburgh, J. S.; Eiriksson, D.

2017-12-01

Environmental data collected by in situ sensors must be reviewed to verify validity, and conducting quality control often requires making edits in post processing to generate approved datasets. This process involves decisions by technicians, data managers, or data users on how to handle problematic data. Options include: removing data from a series, retaining data with annotations, and altering data based on algorithms related to adjacent data points or the patterns of data at other locations or of other variables. Ideally, given the same dataset and the same quality control guidelines, multiple data quality control technicians would make the same decisions in data post processing. However, despite the development and implementation of guidelines aimed to ensure consistent quality control procedures, we have faced ambiguity when performing post processing, and we have noticed inconsistencies in the practices of individuals performing quality control post processing. Technicians with the same level of training and using the same input datasets may produce different results, affecting the overall quality and comparability of finished data products. Different results may also be produced by technicians that do not have the same level of training. In order to assess the effect of subjective decision making by the individual technician on the end data product, we designed an experiment where multiple users performed quality control post processing on the same datasets using a consistent set of guidelines, field notes, and tools. We also assessed the effect of technician experience and training by conducting the same procedures with a group of novices unfamiliar with the data and the quality control process and compared their results to those generated by a group of more experienced technicians. In this presentation, we report our observations of the degree of subjectivity in sensor data post processing, assessing and quantifying the impacts of individual technician as well as technician experience on quality controlled data products.

SeaWiFS Technical Report Series. Volume 38; SeaWiFS Calibration and Validation Quality Control Procedures

NASA Technical Reports Server (NTRS)

Hooker, Stanford B. (Editor); Firestone, Elaine R. (Editor); McClain, Charles R.; Darzi, Michael; Barnes, Robert A.; Eplee, Robert E.; Firestone, James K.; Patt, Frederick S.; Robinson, Wayne D.; Schieber, Brian D.;

Neurophysiological changes associated with implant-associated augmentation procedures in the lower jaw.

PubMed

Hartmann, Amely; Welte-Jzyk, Claudia; Seiler, Marcus; Daubländer, Monika

2017-08-01

Neurophysiological changes after oral and maxillofacial surgery remain one of the topics of current research. This study evaluated if implant placement associated with augmentation procedures increases the possibility of sensory disturbances or result in impaired quality of life during the healing period. Patients who had obtained an implant placement in the lower jaw in combination with augmentation procedures were examined by implementing a comprehensive Quantitative Sensory Testing (QST) protocol for extra- and intraoral use. As augmentation procedures, we used Guided Bone Regeneration (Group A) and Customized Bone Regeneration (Group B) techniques. Patients were tested bilaterally at the chin and mucosal lower lip. Results were compared to a group without augmentation procedures (Group C). Patients' quality of life and psychological comorbidity after the surgical procedures was assessed with the Oral Health Impact Profile and the Hospital Anxiety and Depression Scale. For groups A (n = 20) and B (n = 8), mechanical QST parameters showed no significant differences in all qualities of the inferior alveolar nerve compared to the contralateral side and compared to the nonaugmentation control group (n = 32) as well. Evaluation of quality of life and psychological factors showed no statistical differences. Augmentation procedures did not increase sensory disturbances, indicating no changes in the neurophysiological pathways. Extended augmentation procedures did not lead to sensory changes either or result in an impaired quality of life or modified anxiety and depression scores. © 2017 Wiley Periodicals, Inc.

Materials Testing and Quality Control Soils, 3-28. Military Curriculum Materials for Vocational and Technical Education.

ERIC Educational Resources Information Center

Ohio State Univ., Columbus. National Center for Research in Vocational Education.

This instructional package on material testing and quality control of soils has been adapted from military curriculum materials for use in technical and vocational education programs. This short course presents basic information on soils as well as exploration, field identification, and laboratory procedures that will enable students completing…

40 CFR Table 3 to Subpart Cccccc... - Applicability of General Provisions

Code of Federal Regulations, 2010 CFR

2010-07-01

... procedures; performance audit requirements; internal and external QA procedures for testing Yes. § 63.7(d... quality control plan on record for 5 years; keep old versions for 5 years after revisions No. § 63.8(e...

46 CFR 160.132-9 - Preapproval review.

Code of Federal Regulations, 2014 CFR

2014-10-01

... inventory of materials; (iii) The method for checking quality of fabrication and joints, including welding... §§ 160.132-19 and 160.132-21 of this subpart; (5) A description of the quality control procedures and... between the independent laboratory and Commandant under 46 CFR subpart 159.010. (d) Plan quality. All...

46 CFR 160.132-9 - Preapproval review.

Code of Federal Regulations, 2012 CFR

2012-10-01

... inventory of materials; (iii) The method for checking quality of fabrication and joints, including welding... §§ 160.132-19 and 160.132-21 of this subpart; (5) A description of the quality control procedures and... between the independent laboratory and Commandant under 46 CFR subpart 159.010. (d) Plan quality. All...

46 CFR 160.132-9 - Preapproval review.

Code of Federal Regulations, 2013 CFR

2013-10-01

... inventory of materials; (iii) The method for checking quality of fabrication and joints, including welding... §§ 160.132-19 and 160.132-21 of this subpart; (5) A description of the quality control procedures and... between the independent laboratory and Commandant under 46 CFR subpart 159.010. (d) Plan quality. All...

Quality evaluation and control of end cap welds in PHWR fuel elements by ultrasonic examination

NASA Astrophysics Data System (ADS)

Choi, M. S.; Yang, M. S.

1991-02-01

The current quality control procedure of nuclear fuel end cap weld is mainly dependent on the destructive metallographic examination. A nondestructive examination technique, i.e., ultrasonic examination, has been developed to identify and evaluate weld discontinuities. A few interesting results of the weld quality evaluation by applying the developed ultrasonic examination technique to PHWR fuel welds are presented. In addition, the feasibility of the weld quality control by the ultrasonic examination is discussed. This study shows that the ultrasonic examination is effective and reliable method for detecting abnormal weld contours and weld discontinuities such as micro-fissure, crack, upset split and expulsion, and can be used as a quality control tool for the end cap welding process.

U.S.-MEXICO BORDER PROGRAM ARIZONA BORDER STUDY--STANDARD OPERATING PROCEDURE FOR PREPARATION OF STANDARD OPERATING PROCEDURES (SOPS) (UA-G-1.0)

EPA Science Inventory

The purpose of this SOP is to establish a uniform format for the preparation of SOPs. Use of these protocols ensures consistent implementation of project tasks, documents the preparation and implementation of the procedures used, describes quality control measures and the limits...

Automated Quality Control of in Situ Soil Moisture from the North American Soil Moisture Database Using NLDAS-2 Products

NASA Astrophysics Data System (ADS)

Ek, M. B.; Xia, Y.; Ford, T.; Wu, Y.; Quiring, S. M.

2015-12-01

The North American Soil Moisture Database (NASMD) was initiated in 2011 to provide support for developing climate forecasting tools, calibrating land surface models and validating satellite-derived soil moisture algorithms. The NASMD has collected data from over 30 soil moisture observation networks providing millions of in situ soil moisture observations in all 50 states as well as Canada and Mexico. It is recognized that the quality of measured soil moisture in NASMD is highly variable due to the diversity of climatological conditions, land cover, soil texture, and topographies of the stations and differences in measurement devices (e.g., sensors) and installation. It is also recognized that error, inaccuracy and imprecision in the data set can have significant impacts on practical operations and scientific studies. Therefore, developing an appropriate quality control procedure is essential to ensure the data is of the best quality. In this study, an automated quality control approach is developed using the North American Land Data Assimilation System phase 2 (NLDAS-2) Noah soil porosity, soil temperature, and fraction of liquid and total soil moisture to flag erroneous and/or spurious measurements. Overall results show that this approach is able to flag unreasonable values when the soil is partially frozen. A validation example using NLDAS-2 multiple model soil moisture products at the 20 cm soil layer showed that the quality control procedure had a significant positive impact in Alabama, North Carolina, and West Texas. It had a greater impact in colder regions, particularly during spring and autumn. Over 433 NASMD stations have been quality controlled using the methodology proposed in this study, and the algorithm will be implemented to control data quality from the other ~1,200 NASMD stations in the near future.

Temperature-Controlled Delivery of Radiofrequency Energy in Fecal Incontinence: A Randomized Sham-Controlled Clinical Trial.

PubMed

Visscher, Arjan P; Lam, Tze J; Meurs-Szojda, Maria M; Felt-Bersma, Richelle J F

2017-08-01

Controlled delivery of radiofrequency energy has been suggested as treatment for fecal incontinence. The aim of this study was to determine whether the clinical response to the radiofrequency energy procedure is superior to sham in patients with fecal incontinence. This was a randomized sham-controlled clinical trial from 2008 to 2015. This study was conducted in an outpatient clinic. Forty patients with fecal incontinence in whom maximal conservative management had failed were randomly assigned to receiving either radiofrequency energy or sham procedure. Fecal incontinence was measured using the Vaizey incontinence score (range, 0-24). The impact of fecal incontinence on quality of life was measured by using the fecal incontinence quality-of-life score (range, 1-4). Measurements were performed at baseline and at 6 months. Anorectal function was evaluated using anal manometry and anorectal endosonography at baseline and at 3 months. At baseline, Vaizey incontinence score was 16.8 (SD 2.9). At t = 6 months, the radiofrequency energy group improved by 2.5 points on the Vaizey incontinence score compared with the sham group (13.2 (SD 3.1), 15.6 (SD 3.3), p = 0.02). The fecal incontinence quality-of-life score at t = 6 months was not statistically different. Anorectal function did not show any alteration. Patients with severe fecal incontinence were included in the study, thus making it difficult to generalize the results. Both radiofrequency energy and sham procedure improved the fecal incontinence score, the radiofrequency energy procedure more than sham. Although statistically significant, the clinical impact for most of the patients was negligible. Therefore, the radiofrequency energy procedure should not be recommended for patients with fecal incontinence until patient-related factors associated with treatment success are known. See Video Abstract at http://links.lww.com/DCR/A373.

Development of quality control procedures for mass produced and released Bactrocera Philippinensis (Diptera: Tephritidae) for sterile insect technique programs

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

Resilva, S.; Obra, G.; Zamora, N.

Quality control procedures for Bactrocera philippinensis Drew and Hancock 1994 (Diptera: Tephritidae) used in sterile insect technique (SIT) programs were established in the mass rearing facility at the Philippine Nuclear Research Institute. Basic studies on pupal irradiation, holding/packaging systems, shipping procedures, longevity, sterility studies, and pupal eye color determination in relation to physiological development at different temperature regimes were investigated. These studies will provide baseline data for the development of quality control protocols for an expansion of B. philippinensis field programs with an SIT component in the future. (author) [Spanish] Los procedimientos de control de calidad para Bactrocera philippinensis Drewmore » y Hancock 1994 (Diptera: Tephritidae) usados en programas de la tecnica de insecto esteril (TIE) fueron establecidos en la facilidad de cria en masa del Instituto Filipino de Investigacion Nuclear. Estudios basicos sobre la irradiacion de las pupas, sistemas de almacenaje/empaque, procedimientos del envio, longevidad, estudios de esterilidad y la determinacion del color de ojo de la pupa en relacion con el desarrollo fisiologico en regimenes diferentes de temperatura fueron investigados. Estos estudios proveeran una linea de informacion basica para el desarrollo de protocolos de control de calidad para una expansion de los programas de campo para B. philippinensis con un componente de TIS en el futuro. (author)« less

Food safety and nutritional quality for the prevention of non communicable diseases: the Nutrient, hazard Analysis and Critical Control Point process (NACCP).

PubMed

Di Renzo, Laura; Colica, Carmen; Carraro, Alberto; Cenci Goga, Beniamino; Marsella, Luigi Tonino; Botta, Roberto; Colombo, Maria Laura; Gratteri, Santo; Chang, Ting Fa Margherita; Droli, Maurizio; Sarlo, Francesca; De Lorenzo, Antonino

2015-04-23

The important role of food and nutrition in public health is being increasingly recognized as crucial for its potential impact on health-related quality of life and the economy, both at the societal and individual levels. The prevalence of non-communicable diseases calls for a reformulation of our view of food. The Hazard Analysis and Critical Control Point (HACCP) system, first implemented in the EU with the Directive 43/93/CEE, later replaced by Regulation CE 178/2002 and Regulation CE 852/2004, is the internationally agreed approach for food safety control. Our aim is to develop a new procedure for the assessment of the Nutrient, hazard Analysis and Critical Control Point (NACCP) process, for total quality management (TMQ), and optimize nutritional levels. NACCP was based on four general principles: i) guarantee of health maintenance; ii) evaluate and assure the nutritional quality of food and TMQ; iii) give correct information to the consumers; iv) ensure an ethical profit. There are three stages for the application of the NACCP process: 1) application of NACCP for quality principles; 2) application of NACCP for health principals; 3) implementation of the NACCP process. The actions are: 1) identification of nutritional markers, which must remain intact throughout the food supply chain; 2) identification of critical control points which must monitored in order to minimize the likelihood of a reduction in quality; 3) establishment of critical limits to maintain adequate levels of nutrient; 4) establishment, and implementation of effective monitoring procedures of critical control points; 5) establishment of corrective actions; 6) identification of metabolic biomarkers; 7) evaluation of the effects of food intake, through the application of specific clinical trials; 8) establishment of procedures for consumer information; 9) implementation of the Health claim Regulation EU 1924/2006; 10) starting a training program. We calculate the risk assessment as follows: Risk (R) = probability (P) × damage (D). The NACCP process considers the entire food supply chain "from farm to consumer"; in each point of the chain it is necessary implement a tight monitoring in order to guarantee optimal nutritional quality.

45 CFR 1304.51 - Management systems and procedures.

Code of Federal Regulations, 2013 CFR

2013-10-01

... control program quality, maintain program accountability, and advise governing bodies, policy groups, and... DELEGATE AGENCIES Program Design and Management § 1304.51 Management systems and procedures. (a) Program... program planning that includes consultation with the program's governing body, policy groups, and program...

49 CFR 179.7 - Quality assurance program.

Code of Federal Regulations, 2010 CFR

2010-10-01

... means to detect any nonconformity in the manufacturing, repair, inspection, testing, and qualification... quality control personnel. (3) Procedures to ensure that the latest applicable drawings, design calculations, specifications, and instructions are used in manufacture, inspection, testing, and repair. (4...

Report: Quality Control Review of EPA OIG Reports Issued in Fiscal Year 2015

EPA Pesticide Factsheets

Report #16-N-0223, July 18, 2016. OIG reports issued in FY 2015 demonstrated high levels of compliance with OIG quality assurance procedures, and received average compliance scores of 90 percent or greater.

Quality and Control of Water Vapor Winds

NASA Technical Reports Server (NTRS)

Jedlovec, Gary J.; Atkinson, Robert J.

1996-01-01

Water vapor imagery from the geostationary satellites such as GOES, Meteosat, and GMS provides synoptic views of dynamical events on a continual basis. Because the imagery represents a non-linear combination of mid- and upper-tropospheric thermodynamic parameters (three-dimensional variations in temperature and humidity), video loops of these image products provide enlightening views of regional flow fields, the movement of tropical and extratropical storm systems, the transfer of moisture between hemispheres and from the tropics to the mid- latitudes, and the dominance of high pressure systems over particular regions of the Earth. Despite the obvious larger scale features, the water vapor imagery contains significant image variability down to the single 8 km GOES pixel. These features can be quantitatively identified and tracked from one time to the next using various image processing techniques. Merrill et al. (1991), Hayden and Schmidt (1992), and Laurent (1993) have documented the operational procedures and capabilities of NOAA and ESOC to produce cloud and water vapor winds. These techniques employ standard correlation and template matching approaches to wind tracking and use qualitative and quantitative procedures to eliminate bad wind vectors from the wind data set. Techniques have also been developed to improve the quality of the operational winds though robust editing procedures (Hayden and Veldon 1991). These quality and control approaches have limitations, are often subjective, and constrain wind variability to be consistent with model derived wind fields. This paper describes research focused on the refinement of objective quality and control parameters for water vapor wind vector data sets. New quality and control measures are developed and employed to provide a more robust wind data set for climate analysis, data assimilation studies, as well as operational weather forecasting. The parameters are applicable to cloud-tracked winds as well with minor modifications. The improvement in winds through use of these new quality and control parameters is measured without the use of rawinsonde or modeled wind field data and compared with other approaches.

Development of the Quality Assurance/Quality Control Procedures for a Neutron Interrogation System

NASA Astrophysics Data System (ADS)

Obhođaš, Jasmina; Sudac, Davorin; Valković, Vladivoj

2016-06-01

In order to perform Quality Assurance/Quality Control (QA/QC) procedures for a system dedicated to the neutron interrogation of objects for the presence of threat materials one needs to perform measurements of reference materials (RM) i.e. simulants having the same (or similar) atomic ratios as real materials. It is well known that explosives, drugs, and various other benign materials, contain chemical elements such as hydrogen, oxygen, carbon and nitrogen in distinctly different quantities. For example, a high carbon-to-oxygen ratio (C/O) is characteristic of drugs. Explosives can be differentiated by measurement of both (C/O) and nitrogen-to-oxygen (N/O) ratios. The C/N ratio of the chemical warfare agents, coupled with the measurement of elements such as fluorine and phosphorus, clearly differentiate them from the conventional explosives. Here we present the RM preparation, calibration procedure and correlations attained between theoretical values and experimentally obtained results in laboratory conditions for C/O and N/C ratios of prepared hexogen (RDX), TNT, DLM2, TATP, cocaine, heroin, yperite, tetranitromethane, peroxide methylethylketone, nitromethane and ethyleneglycol dinitrate simulants. We have shown that analyses of the gamma ray spectra by using simple unfolding model developed for this purpose gave a nice agreement with the chemical formula of created simulants, thus the calibration quality was successfully tested.

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

Medicare's Hospital Compare quality reports appear to have slowed price increases for two major procedures.

PubMed

Dor, Avi; Encinosa, William E; Carey, Kathleen

2015-01-01

Previous research has found that Hospital Compare, Medicare's public reporting initiative, has had little impact on patient outcomes. However, little is known about the initiative's impact on hospital prices, which may be significant because private insurers are generally well positioned to respond to quality information when negotiating prices with hospitals. We estimated difference-in-differences models of the effects of Hospital Compare quality reporting on transaction prices for two major cardiac procedures, coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI). States that had mandated their own public reporting systems before the implementation of Hospital Compare formed the control group. We found that prices for these procedures continued to increase overall after the initiation of Hospital Compare quality scores, but the rate of increase was significantly lower in states with no quality reporting metrics of their own before Hospital Compare, when compared to the control states (annual rates of increase of 4.4 percent versus 8.7 percent for PCI, and 3.9 percent versus 10.6 percent for CABG, adjusted for overall inflation). This finding implies that Hospital Compare provided leverage to purchasers in moderating price increases, while adding competitive pressures on hospitals. Providing accurate quality information on both hospitals and health plans could benefit consumers. Project HOPE—The People-to-People Health Foundation, Inc.

Is the Whipple procedure harmful for long-term outcome in treatment of chronic pancreatitis? 15-years follow-up comparing the outcome after pylorus-preserving pancreatoduodenectomy and Frey procedure in chronic pancreatitis.

PubMed

Bachmann, Kai; Tomkoetter, Lena; Kutup, Asad; Erbes, Johannes; Vashist, Yogesh; Mann, Oliver; Bockhorn, Maximilian; Izbicki, Jakob R

2013-11-01

The aim of this study was to report on 15-year long-term results of a randomized controlled trial comparing extended drainage procedure (Frey) and classical resectional procedure [pylorus-preserving pancreatoduodenectomy (PD)] in patients with chronic pancreatitis. Chronic pancreatitis is a common inflammatory disease with a prevalence of 10 to 30 cases per 100,000 inhabitants. It is characterized by the progressive conversion of pancreatic parenchyma to fibrous tissue. Different surgical procedures are used in treatment of persistent pain. Sixty-four patients suffering from chronic pancreatitis with inflammatory mass in the pancreatic head were randomly assigned in 2 treatment groups (PD, n = 32) and (Frey, n = 32). The perioperative course of the randomized controlled trial and the 7 years follow-up have been previously published. All participating patients were contacted with a standardized, validated questionnaire (EORTC QLQ C30) to evaluate the long-term survival, quality-of-life pain, and exocrine and endocrine function. In the 15-year long-term follow-up, the pain control was good and comparable between both groups, but the quality of life was better after Frey procedure in regard of the physical status [PD: 100 (0-100) vs PD: 60 (0-100) (P = 0.011)]. No significant differences in terms of the Pain Score were detected between both groups [PD: 7 (0-100) vs Frey 4 (0-100) P = 0.258]. Seven patients after Frey OP and 6 patients after PD were free of pain. Analyzing the postoperative overall survival, a higher long-term mortality was found after PD (53%) than that found after Frey procedure (30%) resulting in a longer mean survival (14.5 ± 0.8 vs 11.3 ± 0.8 years; P = 0.037). No correlation between endocrine or exocrine pancreatic function and pain was found, whereas continuous alcohol consumption was associated with poorer outcome regarding quality of life (P < 0.001) and pain score (P < 0.001). PD and Frey procedure provide good and permanent pain relief and improvement of the quality of life in long-term follow-up. In addition, a longer survival was found after the organ sparing resection. Together with better short-term results, the organ-sparing procedure seems to be favorable in treatment of chronic pancreatitis.

Quality Assurance of RNA Expression Profiling in Clinical Laboratories

PubMed Central

Tang, Weihua; Hu, Zhiyuan; Muallem, Hind; Gulley, Margaret L.

2012-01-01

RNA expression profiles are increasingly used to diagnose and classify disease, based on expression patterns of as many as several thousand RNAs. To ensure quality of expression profiling services in clinical settings, a standard operating procedure incorporates multiple quality indicators and controls, beginning with preanalytic specimen preparation and proceeding thorough analysis, interpretation, and reporting. Before testing, histopathological examination of each cellular specimen, along with optional cell enrichment procedures, ensures adequacy of the input tissue. Other tactics include endogenous controls to evaluate adequacy of RNA and exogenous or spiked controls to evaluate run- and patient-specific performance of the test system, respectively. Unique aspects of quality assurance for array-based tests include controls for the pertinent outcome signatures that often supersede controls for each individual analyte, built-in redundancy for critical analytes or biochemical pathways, and software-supported scrutiny of abundant data by a laboratory physician who interprets the findings in a manner facilitating appropriate medical intervention. Access to high-quality reagents, instruments, and software from commercial sources promotes standardization and adoption in clinical settings, once an assay is vetted in validation studies as being analytically sound and clinically useful. Careful attention to the well-honed principles of laboratory medicine, along with guidance from government and professional groups on strategies to preserve RNA and manage large data sets, promotes clinical-grade assay performance. PMID:22020152

40 CFR Appendix F to Part 60 - Quality Assurance Procedures

Code of Federal Regulations, 2012 CFR

2012-07-01

... automatically adjust the data to the corrected calibration values (e.g., microprocessor control) must be... calibration values (e.g., microprocessor control), you must program your PM CEMS to record the unadjusted...

Increasing the quality, comparability and accessibility of phytoplankton species composition time-series data

NASA Astrophysics Data System (ADS)

Zingone, Adriana; Harrison, Paul J.; Kraberg, Alexandra; Lehtinen, Sirpa; McQuatters-Gollop, Abigail; O'Brien, Todd; Sun, Jun; Jakobsen, Hans H.

2015-09-01

Phytoplankton diversity and its variation over an extended time scale can provide answers to a wide range of questions relevant to societal needs. These include human health, the safe and sustained use of marine resources and the ecological status of the marine environment, including long-term changes under the impact of multiple stressors. The analysis of phytoplankton data collected at the same place over time, as well as the comparison among different sampling sites, provide key information for assessing environmental change, and evaluating new actions that must be made to reduce human induced pressures on the environment. To achieve these aims, phytoplankton data may be used several decades later by users that have not participated in their production, including automatic data retrieval and analysis. The methods used in phytoplankton species analysis vary widely among research and monitoring groups, while quality control procedures have not been implemented in most cases. Here we highlight some of the main differences in the sampling and analytical procedures applied to phytoplankton analysis and identify critical steps that are required to improve the quality and inter-comparability of data obtained at different sites and/or times. Harmonization of methods may not be a realistic goal, considering the wide range of purposes of phytoplankton time-series data collection. However, we propose that more consistent and detailed metadata and complementary information be recorded and made available along with phytoplankton time-series datasets, including description of the procedures and elements allowing for a quality control of the data. To keep up with the progress in taxonomic research, there is a need for continued training of taxonomists, and for supporting and complementing existing web resources, in order to allow a constant upgrade of knowledge in phytoplankton classification and identification. Efforts towards the improvement of metadata recording, data annotation and quality control procedures will ensure the internal consistency of phytoplankton time series and facilitate their comparability and accessibility, thus strongly increasing the value of the precious information they provide. Ultimately, the sharing of quality controlled data will allow one to recoup the high cost of obtaining the data through the multiple use of the time-series data in various projects over many decades.

Quality of mass-reared codling moth (Lepidoptera: Tortricidae) after long distance transportation 1. Logistics of shipping procedures and quality parameters as measured in the laboratory.

USDA-ARS?s Scientific Manuscript database

The sterile insect technique is a proven effective control tactic against lepidopteran pests when applied in an area-wide integrated pest management programme. The construction of insect mass-rearing facilities requires considerable investment and moth control strategies that include the use of ster...

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

Development and Exchange of Instructional Resources in Water Quality Control Programs, IV: Selecting Instructional Media and Instructional Systems.

ERIC Educational Resources Information Center

Durham, W. Harry; And Others

This document is one of a series of reports which reviews instructional materials and equipment for water and wastewater treatment plant personnel. A system is presented to assist in standardizing the production of lesson plans and instructional materials in the water quality control field. A procedure for selecting appropriate instructional media…

Basal Area Growth Estimators for Survivor Component: A Quality Control Application

Treesearch

Charles E. Thomas; Francis A. Roesch

1990-01-01

Several possible estimators are available for basal area growth of survivor trees, when horizontal prism (or point) plots (HPP) are remeasured. This study's comparison of three estimators not only provides a check for the estimate of basal area growth but suggests that they can provide a quality control indicator for yield procedures. An example is derived from...

40 CFR Appendix B to Part 75 - Quality Assurance and Quality Control Procedures

Code of Federal Regulations, 2014 CFR

2014-07-01

... transmitters of an orifice-, nozzle-, or venturi-type fuel flowmeter under section 2.1.6 of appendix D to this... nozzle) of an orifice-, venturi-, or nozzle-type fuel flowmeter. Examples of the types of information to..., but ≤200 ppm). The out-of-control period begins upon failure of the calibration error test and ends...

BIOMONITORING TO ACHIEVE CONTROL OF TOXIC EFFLUENTS

EPA Science Inventory

This 48 - page Technology Transfer Report provides a case study of how water quality-based toxicity control procedures can be combined with chemical analyses and biological stream surveys to achieve more effective water pollution control. t describes how regulatory agencies used ...

46 CFR 160.115-9 - Preapproval review.

Code of Federal Regulations, 2012 CFR

2012-10-01

... inventory of materials; (iii) The method for checking quality of fabrication and joints, including welding... §§ 160.115-19 and 160.115-21 of this subpart; (5) A description of the quality control procedures and... between the independent laboratory and Commandant under 46 CFR part 159, subpart 159.010. (d) Plan quality...

46 CFR 160.115-9 - Preapproval review.

Code of Federal Regulations, 2014 CFR

2014-10-01

... inventory of materials; (iii) The method for checking quality of fabrication and joints, including welding... §§ 160.115-19 and 160.115-21 of this subpart; (5) A description of the quality control procedures and... between the independent laboratory and Commandant under 46 CFR part 159, subpart 159.010. (d) Plan quality...

46 CFR 160.115-9 - Preapproval review.

Code of Federal Regulations, 2013 CFR

2013-10-01

... inventory of materials; (iii) The method for checking quality of fabrication and joints, including welding... §§ 160.115-19 and 160.115-21 of this subpart; (5) A description of the quality control procedures and... between the independent laboratory and Commandant under 46 CFR part 159, subpart 159.010. (d) Plan quality...

14 CFR 21.303 - Replacement and modification parts.

Code of Federal Regulations, 2010 CFR

2010-01-01

... determination can be made. Statistical quality control procedures may be employed where it is shown that a... AIRCRAFT CERTIFICATION PROCEDURES FOR PRODUCTS AND PARTS Approval of Materials, Parts, Processes, and... the configuration of the part; and (ii) Information on dimensions, materials, and processes necessary...

Guidebook: Quality Assurance/Quality Control Procedures for Submission of Data for the Land Disposal Restrictions (LDR) Program

EPA Pesticide Factsheets

This document explains how to generate data which characterizes the performance of hazardous waste treatment systems in terms of the composition of treated hazardous waste streams plus treatment system operation and design.

PACS quality control and automatic problem notifier

NASA Astrophysics Data System (ADS)

Honeyman-Buck, Janice C.; Jones, Douglas; Frost, Meryll M.; Staab, Edward V.

1997-05-01

One side effect of installing a clinical PACS Is that users become dependent upon the technology and in some cases it can be very difficult to revert back to a film based system if components fail. The nature of system failures range from slow deterioration of function as seen in the loss of monitor luminance through sudden catastrophic loss of the entire PACS networks. This paper describes the quality control procedures in place at the University of Florida and the automatic notification system that alerts PACS personnel when a failure has happened or is anticipated. The goal is to recover from a failure with a minimum of downtime and no data loss. Routine quality control is practiced on all aspects of PACS, from acquisition, through network routing, through display, and including archiving. Whenever possible, the system components perform self and between platform checks for active processes, file system status, errors in log files, and system uptime. When an error is detected or a exception occurs, an automatic page is sent to a pager with a diagnostic code. Documentation on each code, trouble shooting procedures, and repairs are kept on an intranet server accessible only to people involved in maintaining the PACS. In addition to the automatic paging system for error conditions, acquisition is assured by an automatic fax report sent on a daily basis to all technologists acquiring PACS images to be used as a cross check that all studies are archived prior to being removed from the acquisition systems. Daily quality control is preformed to assure that studies can be moved from each acquisition and contrast adjustment. The results of selected quality control reports will be presented. The intranet documentation server will be described with the automatic pager system. Monitor quality control reports will be described and the cost of quality control will be quantified. As PACS is accepted as a clinical tool, the same standards of quality control must be established as are expected on other equipment used in the diagnostic process.

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...

[Establishment and application of "multi-dimensional structure and process dynamic quality control technology system" in preparation products of traditional Chinese medicine (I)].

PubMed

Gu, Jun-Fei; Feng, Liang; Zhang, Ming-Hua; Wu, Chan; Jia, Xiao-Bin

2013-11-01

Safety is an important component of the quality control of traditional Chinese medicine (TCM) preparation products, as well as an important guarantee for clinical application. Currently, the quality control of TCMs in Chinese Pharmacopoeia mostly focuses on indicative compounds for TCM efficacy. TCM preparations are associated with multiple links, from raw materials to products, and each procedure may have impacts on the safety of preparation. We make a summary and analysis on the factors impacting safety during the preparation of TCM products, and then expound the important role of the "multi-dimensional structure and process dynamic quality control technology system" in the quality safety of TCM preparations. Because the product quality of TCM preparation is closely related to the safety, the control over safety-related material basis is an important component of the product quality control of TCM preparations. The implementation of the quality control over the dynamic process of TCM preparations from raw materials to products, and the improvement of the TCM quality safety control at the microcosmic level help lay a firm foundation for the development of the modernization process of TCM preparations.

Evaluation of variability and quality control procedures for a receptor-binding assay for paralytic shellfish poisoning toxins.

PubMed

Ruberu, S R; Langlois, G W; Masuda, M; Perera, S Kusum

2012-01-01

The receptor-binding assay (RBA) method for determining saxatoxin (STX) and its numerous analogues, which cause paralytic shellfish poisoning (PSP) in humans, was evaluated in a single laboratory study. Each step of the assay preparation procedure including the performance of the multi-detector TopCount® instrument was evaluated for its contribution to method variability. The overall inherent RBA variability was determined to be 17%. Variability within the 12 detectors was observed; however, there was no reproducible pattern in detector performance. This observed variability among detectors could be attributed to other factors, such as pipetting errors. In an attempt to reduce the number of plates rejected due to excessive variability in the method's quality control parameters, a statistical approach was evaluated using either Grubbs' test or the Student's t-test for rejecting outliers in the measurement of triplicate wells. This approach improved the ratio of accepted versus rejected plates, saving cost and time for rerunning the assay. However, the potential reduction in accuracy and the lack of improvement in precision suggests caution when using this approach. The current study has recommended an alternate quality control procedure for accepting or rejecting plates in place of the criteria currently used in the published assay, or the alternative of outlier testing. The recommended procedure involves the development of control charts to monitor the critical parameters identified in the published method (QC sample, EC₅₀, slope of calibration curve), with the addition of a fourth critical parameter which is the top value (100% binding) of the calibration curve.

21 CFR 211.160 - General requirements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... drafted by the appropriate organizational unit and reviewed and approved by the quality control unit. The...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory Controls § 211.160... procedures, or other laboratory control mechanisms required by this subpart, including any change in such...

[Nursing service certification. Norm UNE-EN-ISO 9001-2008].

PubMed

Salazar de la Guerra, R; Ferrer Arnedo, C; Labrador Domínguez, M J; Sangregorio Matesanz, A

2014-01-01

To certify the nursing services using a quality management system, taking an international standard as a reference, and based on a continuous improvement process. The standard was revised, and the Quality Management System documentation was updated, consisting of a Quality Manual and 7 control procedures. All the existing procedures were coded in accordance with the documentation control process. Each operational procedure was associated with a set of indicators which permitted to know the results obtained, analyze the deviations and to implement further improvements. The system was implemented successfully. Twenty-eight care procedures and eleven procedures concerning techniques were incorporated into the management system. Thirty indicators were established that allowed the whole process to be monitored. All patients were assigned to a nurse in their clinical notes and all of them had a personalized Care Plan according to planning methodology using North American Nursing Diagnosis Association (NANDA), Nursing Interventions Classification (NIC) and Nursing Outcomes Classification (NOC) international rankings. The incidence of falls, as well as the incidence of chronic skin wounds, was low, taking into account the characteristics of the patient and the duration of the stay (mean=35.87 days). The safety indicators had a high level of compliance, with 90% of patients clearly identified and 100% with hygiene protocol. The confidence rating given to the nurses was 91%. The certification enabled the quality of the service to be improved using a structured process, analyzing the results, dealing with non-conformities and introducing improvements. Copyright © 2014 SECA. Published by Elsevier Espana. All rights reserved.

Six Sigma Quality Management System and Design of Risk-based Statistical Quality Control.

PubMed

Westgard, James O; Westgard, Sten A

2017-03-01

Six sigma concepts provide a quality management system (QMS) with many useful tools for managing quality in medical laboratories. This Six Sigma QMS is driven by the quality required for the intended use of a test. The most useful form for this quality requirement is the allowable total error. Calculation of a sigma-metric provides the best predictor of risk for an analytical examination process, as well as a design parameter for selecting the statistical quality control (SQC) procedure necessary to detect medically important errors. Simple point estimates of sigma at medical decision concentrations are sufficient for laboratory applications. Copyright © 2016 Elsevier Inc. All rights reserved.

Application of reiteration of Hankel singular value decomposition in quality control

NASA Astrophysics Data System (ADS)

Staniszewski, Michał; Skorupa, Agnieszka; Boguszewicz, Łukasz; Michalczuk, Agnieszka; Wereszczyński, Kamil; Wicher, Magdalena; Konopka, Marek; Sokół, Maria; Polański, Andrzej

2017-07-01

Medical centres are obliged to store past medical records, including the results of quality assurance (QA) tests of the medical equipment, which is especially useful in checking reproducibility of medical devices and procedures. Analysis of multivariate time series is an important part of quality control of NMR data. In this work we proposean anomaly detection tool based on Reiteration of Hankel Singular Value Decomposition method. The presented method was compared with external software and authors obtained comparable results.

State of Technology for Renewal of Sewer Force Mains

EPA Science Inventory

This paper presents the results of a review of the state of technology for renewal of force mains (EPA, 2010). The review identified several needs, including the need for rational and common design approaches for rehabilitation systems, quality assurance/quality control procedur...

Quality Assurance Specifications for Planetary Protection Assays

NASA Astrophysics Data System (ADS)

Baker, Amy

As the European Space Agency planetary protection (PP) activities move forward to support the ExoMars and other planetary missions, it will become necessary to increase staffing of labo-ratories that provide analyses for these programs. Standardization of procedures, a comprehen-sive quality assurance program, and unilateral training of personnel will be necessary to ensure that the planetary protection goals and schedules are met. The PP Quality Assurance/Quality Control (QAQC) program is designed to regulate and monitor procedures performed by labora-tory personnel to ensure that all work meets data quality objectives through the assembly and launch process. Because personnel time is at a premium and sampling schedules are often de-pendent on engineering schedules, it is necessary to have flexible staffing to support all sampling requirements. The most productive approach to having a competent and flexible work force is to establish well defined laboratory procedures and training programs that clearly address the needs of the program and the work force. The quality assurance specification for planetary protection assays has to ensure that labora-tories and associated personnel can demonstrate the competence to perform assays according to the applicable standard AD4. Detailed subjects included in the presentation are as follows: • field and laboratory control criteria • data reporting • personnel training requirements and certification • laboratory audit criteria. Based upon RD2 for primary and secondary validation and RD3 for data quality objectives, the QAQC will provide traceable quality assurance safeguards by providing structured laboratory requirements for guidelines and oversight including training and technical updates, standardized documentation, standardized QA/QC checks, data review and data archiving.

Guidelines for the processing and quality assurance of benthic invertebrate samples collected as part of the National Water-Quality Assessment Program

USGS Publications Warehouse

Cuffney, T.F.; Gurtz, M.E.; Meador, M.R.

1993-01-01

Benthic invertebrate samples are collected as part of the U.S. Geological Survey's National Water-Quality Assessment Program. This is a perennial, multidisciplinary program that integrates biological, physical, and chemical indicators of water quality to evaluate status and trends and to develop an understanding of the factors controlling observed water quality. The Program examines water quality in 60 study units (coupled ground- and surface-water systems) that encompass most of the conterminous United States and parts of Alaska and Hawaii. Study-unit teams collect and process qualitative and semi-quantitative invertebrate samples according to standardized procedures. These samples are processed (elutriated and subsampled) in the field to produce as many as four sample components: large-rare, main-body, elutriate, and split. Each sample component is preserved in 10-percent formalin, and two components, large-rare and main-body, are sent to contract laboratories for further processing. The large-rare component is composed of large invertebrates that are removed from the sample matrix during field processing and placed in one or more containers. The main-body sample component consists of the remaining sample materials (sediment, detritus, and invertebrates) and is subsampled in the field to achieve a volume of 750 milliliters or less. The remaining two sample components, elutriate and split, are used for quality-assurance and quality-control purposes. Contract laboratories are used to identify and quantify invertebrates from the large-rare and main-body sample components according to the procedures and guidelines specified within this document. These guidelines allow the use of subsampling techniques to reduce the volume of sample material processed and to facilitate identifications. These processing procedures and techniques may be modified if the modifications provide equal or greater levels of accuracy and precision. The intent of sample processing is to determine the quantity of each taxon present in the semi-quantitative samples or to list the taxa present in qualitative samples. The processing guidelines provide standardized laboratory forms, sample labels, detailed sample processing flow charts, standardized format for electronic data, quality-assurance procedures and checks, sample tracking standards, and target levels for taxonomic determinations. The contract laboratory (1) is responsible for identifications and quantifications, (2) constructs reference collections, (3) provides data in hard copy and electronic forms, (4) follows specified quality-assurance and quality-control procedures, and (5) returns all processed and unprocessed portions of the samples. The U.S. Geological Survey's Quality Management Group maintains a Biological Quality-Assurance Unit, located at the National Water-Quality Laboratory, Arvada, Colorado, to oversee the use of contract laboratories and ensure the quality of data obtained from these laboratories according to the guidelines established in this document. This unit establishes contract specifications, reviews contractor performance (timeliness, accuracy, and consistency), enters data into the National Water Information System-II data base, maintains in-house reference collections, deposits voucher specimens in outside museums, and interacts with taxonomic experts within and outside the U.S. Geological Survey. This unit also modifies the existing sample processing and quality-assurance guidelines, establishes criteria and testing procedures for qualifying potential contract laboratories, identifies qualified taxonomic experts, and establishes voucher collections.

A Total Quality-Control Plan with Right-Sized Statistical Quality-Control.

PubMed

Westgard, James O

2017-03-01

A new Clinical Laboratory Improvement Amendments option for risk-based quality-control (QC) plans became effective in January, 2016. Called an Individualized QC Plan, this option requires the laboratory to perform a risk assessment, develop a QC plan, and implement a QC program to monitor ongoing performance of the QC plan. Difficulties in performing a risk assessment may limit validity of an Individualized QC Plan. A better alternative is to develop a Total QC Plan including a right-sized statistical QC procedure to detect medically important errors. Westgard Sigma Rules provides a simple way to select the right control rules and the right number of control measurements. Copyright © 2016 Elsevier Inc. All rights reserved.

Quality Control Analysis of Selected Aspects of Programs Administered by the Bureau of Student Financial Assistance. Task 1 and Quality Control Sample; Error-Prone Modeling Analysis Plan.

ERIC Educational Resources Information Center

Saavedra, Pedro; And Others

Parameters and procedures for developing an error-prone model (EPM) to predict financial aid applicants who are likely to misreport on Basic Educational Opportunity Grant (BEOG) applications are introduced. Specifications to adapt these general parameters to secondary data analysis of the Validation, Edits, and Applications Processing Systems…

The Development of a Technical Conceptual Structure for the Concepts Possessed by Selected Quality Control Specialists. Report of a Research Project.

ERIC Educational Resources Information Center

Nee, John G.

This project had as its specific objective the development and field testing of a procedure for identifying the structure of technical concepts possessed by a group of selected quality control specialists. The associative theory of verbal behavior served as the rationale by which conceptual structures depicted by graphical maps of technical…

Quality Control for Scoring Tests Administered in Continuous Mode: An NCME Instructional Module

ERIC Educational Resources Information Center

Allalouf, Avi; Gutentag, Tony; Baumer, Michal

2017-01-01

Quality control (QC) in testing is paramount. QC procedures for tests can be divided into two types. The first type, one that has been well researched, is QC for tests administered to large population groups on few administration dates using a small set of test forms (e.g., large-scale assessment). The second type is QC for tests, usually…

Collection, quality control and delivery of ground-based magnetic data during ESA's Swarm mission

NASA Astrophysics Data System (ADS)

Macmillan, Susan; Humphries, Thomas; Flower, Simon; Swan, Anthony

2016-04-01

Ground-based magnetic data are used in a variety of ways when analysing satellite data. Selecting satellite data often involves the use of magnetic disturbance indices derived from ground-based stations and inverting satellite magnetic data for models of fields from various sources often requires ground-based data. Ground-based data can also be valuable independent data for validation purposes. We summarise data collection and quality control procedures in place at the British Geological Survey for global ground-based observatory and repeat station data. Whilst ongoing participation in the ICSU World Data System and INTERMAGNET facilitates this work, additional procedures have been specially developed for the Swarm mission. We describe these in detail.

Surface evaluation of orthopedic hip implants marketed in Brazil

NASA Astrophysics Data System (ADS)

Souza, M. M.; Trommer, R. M.; Maru, M. M.; Roesler, C. R. M.; Barros, W. S.; Dutra, M. S.

2016-07-01

One of the factors that contribute to the quality of total hip prostheses is the degree of accuracy in the manufacturing of the joint surfaces. The dimensional control of joint components is important because of its direct influence on the durability and, consequently, in the patients’ life quality. This work presents studies on the form and roughness of orthopedic hip prostheses marketed in Brazil. The results provide data for quality control of the surfaces of the femoral heads and acetabular components of hip prostheses and indicate the need of improvement in the procedures used to this control.

Computer graphics for quality control in the INAA of geological samples

USGS Publications Warehouse

Grossman, J.N.; Baedecker, P.A.

1987-01-01

A data reduction system for the routine instrumental activation analysis of samples is described, with particular emphasis on interactive graphics capabilities for evaluating analytical quality. Graphics procedures have been developed to interactively control the analysis of selected photopeaks during spectral analysis, and to evaluate detector performance during a given counting cycle. Graphics algorithms are also used to compare the data on reference samples with accepted values, to prepare quality control charts to evaluate long term precision and to search for systematic variations in data on reference samples as a function of time. ?? 1987 Akade??miai Kiado??.

A randomized controlled trial of electrocoagulation-enabled biopsy versus conventional biopsy in the diagnosis of endobronchial lesions.

PubMed

Khan, Ajmal; Aggarwal, Ashutosh N; Agarwal, Ritesh; Bal, Amanjit; Gupta, Dheeraj

2011-01-01

Although electrocoagulation at time of endobronchial biopsy can potentially reduce procedure-related bleeding during fiberoptic bronchoscopy (FOB), it can also impair quality of tissue specimen; credible data for either are lacking. To evaluate the impact of hot biopsy on the quality of tissue samples and to quantify the amount of procedure-related bleeding during endobronchial biopsy. In this single-center, prospective, single-blind, randomized controlled study we included adult patients referred for FOB and having endobronchial lesions. Patients were randomized to bronchial biopsy using an electrocoagulation-enabled biopsy forceps, with (EC+ group) or without (EC- group) application of electrocoagulation current (40 W for 10 s in a monopolar mode). Procedure-related bleeding was semi-quantified by observer description, as well as through a visual analogue scale. Overall quality of biopsy specimen and tissue damage were assessed and graded by a pulmonary pathologist blinded to FOB details. 160 patients were randomized to endobronchial biopsy with (n = 81) or without (n = 79) the application of electrocoagulation. There were no severe bleeding episodes in either group, and severity of bleeding in the EC+ and EC- groups was similar (median visual analogue scale scores of 14 and 16, respectively). Histopathological diagnosis was similar in the EC+ and EC- groups (77.8% and 82.3%, respectively). There was no significant difference in tissue quality between the two groups. Use of electrocoagulation-enabled endobronchial biopsy does not alter specimen quality and does not result in any significant reduction in procedure-related bleeding. Copyright © 2010 S. Karger AG, Basel.

21 CFR 820.30 - Design controls.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Design controls. 820.30 Section 820.30 Food and... QUALITY SYSTEM REGULATION Design Controls § 820.30 Design controls. (a) General. (1) Each manufacturer of..., shall establish and maintain procedures to control the design of the device in order to ensure that...

21 CFR 820.30 - Design controls.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Design controls. 820.30 Section 820.30 Food and... QUALITY SYSTEM REGULATION Design Controls § 820.30 Design controls. (a) General. (1) Each manufacturer of..., shall establish and maintain procedures to control the design of the device in order to ensure that...

21 CFR 820.30 - Design controls.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Design controls. 820.30 Section 820.30 Food and... QUALITY SYSTEM REGULATION Design Controls § 820.30 Design controls. (a) General. (1) Each manufacturer of..., shall establish and maintain procedures to control the design of the device in order to ensure that...

21 CFR 820.30 - Design controls.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Design controls. 820.30 Section 820.30 Food and... QUALITY SYSTEM REGULATION Design Controls § 820.30 Design controls. (a) General. (1) Each manufacturer of..., shall establish and maintain procedures to control the design of the device in order to ensure that...

21 CFR 820.30 - Design controls.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Design controls. 820.30 Section 820.30 Food and... QUALITY SYSTEM REGULATION Design Controls § 820.30 Design controls. (a) General. (1) Each manufacturer of..., shall establish and maintain procedures to control the design of the device in order to ensure that...

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.

Statistical Methods in Assembly Quality Management of Multi-Element Products on Automatic Rotor Lines

NASA Astrophysics Data System (ADS)

Pries, V. V.; Proskuriakov, N. E.

2018-04-01

To control the assembly quality of multi-element mass-produced products on automatic rotor lines, control methods with operational feedback are required. However, due to possible failures in the operation of the devices and systems of automatic rotor line, there is always a real probability of getting defective (incomplete) products into the output process stream. Therefore, a continuous sampling control of the products completeness, based on the use of statistical methods, remains an important element in managing the quality of assembly of multi-element mass products on automatic rotor lines. The feature of continuous sampling control of the multi-element products completeness in the assembly process is its breaking sort, which excludes the possibility of returning component parts after sampling control to the process stream and leads to a decrease in the actual productivity of the assembly equipment. Therefore, the use of statistical procedures for continuous sampling control of the multi-element products completeness when assembled on automatic rotor lines requires the use of such sampling plans that ensure a minimum size of control samples. Comparison of the values of the limit of the average output defect level for the continuous sampling plan (CSP) and for the automated continuous sampling plan (ACSP) shows the possibility of providing lower limit values for the average output defects level using the ACSP-1. Also, the average sample size when using the ACSP-1 plan is less than when using the CSP-1 plan. Thus, the application of statistical methods in the assembly quality management of multi-element products on automatic rotor lines, involving the use of proposed plans and methods for continuous selective control, will allow to automating sampling control procedures and the required level of quality of assembled products while minimizing sample size.

A Model of Risk Analysis in Analytical Methodology for Biopharmaceutical Quality Control.

PubMed

Andrade, Cleyton Lage; Herrera, Miguel Angel De La O; Lemes, Elezer Monte Blanco

2018-01-01

One key quality control parameter for biopharmaceutical products is the analysis of residual cellular DNA. To determine small amounts of DNA (around 100 pg) that may be in a biologically derived drug substance, an analytical method should be sensitive, robust, reliable, and accurate. In principle, three techniques have the ability to measure residual cellular DNA: radioactive dot-blot, a type of hybridization; threshold analysis; and quantitative polymerase chain reaction. Quality risk management is a systematic process for evaluating, controlling, and reporting of risks that may affects method capabilities and supports a scientific and practical approach to decision making. This paper evaluates, by quality risk management, an alternative approach to assessing the performance risks associated with quality control methods used with biopharmaceuticals, using the tool hazard analysis and critical control points. This tool provides the possibility to find the steps in an analytical procedure with higher impact on method performance. By applying these principles to DNA analysis methods, we conclude that the radioactive dot-blot assay has the largest number of critical control points, followed by quantitative polymerase chain reaction, and threshold analysis. From the analysis of hazards (i.e., points of method failure) and the associated method procedure critical control points, we conclude that the analytical methodology with the lowest risk for performance failure for residual cellular DNA testing is quantitative polymerase chain reaction. LAY ABSTRACT: In order to mitigate the risk of adverse events by residual cellular DNA that is not completely cleared from downstream production processes, regulatory agencies have required the industry to guarantee a very low level of DNA in biologically derived pharmaceutical products. The technique historically used was radioactive blot hybridization. However, the technique is a challenging method to implement in a quality control laboratory: It is laborious, time consuming, semi-quantitative, and requires a radioisotope. Along with dot-blot hybridization, two alternatives techniques were evaluated: threshold analysis and quantitative polymerase chain reaction. Quality risk management tools were applied to compare the techniques, taking into account the uncertainties, the possibility of circumstances or future events, and their effects upon method performance. By illustrating the application of these tools with DNA methods, we provide an example of how they can be used to support a scientific and practical approach to decision making and can assess and manage method performance risk using such tools. This paper discusses, considering the principles of quality risk management, an additional approach to the development and selection of analytical quality control methods using the risk analysis tool hazard analysis and critical control points. This tool provides the possibility to find the method procedural steps with higher impact on method reliability (called critical control points). Our model concluded that the radioactive dot-blot assay has the larger number of critical control points, followed by quantitative polymerase chain reaction and threshold analysis. Quantitative polymerase chain reaction is shown to be the better alternative analytical methodology in residual cellular DNA analysis. © PDA, Inc. 2018.

[Strategies and development of quality assurance and control in the ELSA-Brasil].

PubMed

Schmidt, Maria Inês; Griep, Rosane Härter; Passos, Valéria Maria; Luft, Vivian Cristine; Goulart, Alessandra Carvalho; Menezes, Greice Maria de Souza; Molina, Maria del Carmen Bisi; Vigo, Alvaro; Nunes, Maria Angélica

2013-06-01

The ELSA-Brasil (Estudo Longitudinal de Saúde do Adulto - Brazilian Longitudinal Study for Adult Health) is a cohort study composed of 15,105 adults followed up in order to assess the development of chronic diseases, especially diabetes and cardiovascular disease. Its size, multicenter nature and the diversity of measurements required effective and efficient mechanisms of quality assurance and control. The main quality assurance activities (those developed before data collection) were: careful selection of research instruments, centralized training and certification, pretesting and pilot studies, and preparation of operation manuals for the procedures. Quality control activities (developed during data collection and processing) were performed more intensively at the beginning, when routines had not been established yet. The main quality control activities were: periodic observation of technicians, test-retest studies, data monitoring, network of supervisors, and cross visits. Data that estimate the reliability of the obtained information attest that the quality goals have been achieved.

A simple and cheap system to speed up and to control the tumescent technique procedure: the Tedde's system.

PubMed

Rubino, C; Marongiu, F; Manzo, M J; Tedde, G; Madonia, M; Campus, G V; Farace, F

2014-06-01

We have devised a low cost system to quickly infiltrate tumescent solution: we call it the "Tedde's system". This low-cost system offers an improvement in quality and quantity of the infiltration because all the procedure depends on the operators, reducing also the time of the infiltration and consequently of the whole surgical procedure. Moreover, this system can be applied to other surgical procedure that requires large infiltration volumes.

40 CFR 63.10 - Recordkeeping and reporting requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... alternative reporting arrangements, in advance, with the permitting authority in that State. Procedures... manufacturer(s) and model number(s); (G) The date of the latest CMS certification or audit; (H) The total..., nonmonitoring equipment malfunctions, quality assurance/quality control calibrations, other known causes, and...

12 CFR 652.60 - Corporation board guidelines.

Code of Federal Regulations, 2010 CFR

2010-01-01

.... (a) Your board of directors is responsible for ensuring that you maintain total capital at a level... developing the capital adequacy plan: (1) Capability of management; (2) Strategies and objectives in your business plan; (3) Quality of operating policies, procedures, and internal controls; (4) Quality and...

12 CFR 652.60 - Corporation board guidelines.

Code of Federal Regulations, 2011 CFR

2011-01-01

.... (a) Your board of directors is responsible for ensuring that you maintain total capital at a level... developing the capital adequacy plan: (1) Capability of management; (2) Strategies and objectives in your business plan; (3) Quality of operating policies, procedures, and internal controls; (4) Quality and...

The complications of controlling agency time discretion: FDA review deadlines and postmarket drug safety.

PubMed

Carpenter, Daniel; Chattopadhyay, Jacqueline; Moffitt, Susan; Nall, Clayton

2012-01-01

Public agencies have discretion on the time domain, and politicians deploy numerous policy instruments to constrain it. Yet little is known about how administrative procedures that affect timing also affect the quality of agency decisions. We examine whether administrative deadlines shape decision timing and the observed quality of decisions. Using a unique and rich dataset of FDA drug approvals that allows us to examine decision timing and quality, we find that this administrative tool induces a piling of decisions before deadlines, and that these “just-before-deadline” approvals are linked with higher rates of postmarket safety problems (market withdrawals, severe safety warnings, safety alerts). Examination of data from FDA advisory committees suggests that the deadlines may impede quality by impairing late-stage deliberation and agency risk communication. Our results both support and challenge reigning theories about administrative procedures, suggesting they embody expected control-expertise trade-offs, but may also create unanticipated constituency losses.

Quality control considerations for the determination of acid-volatile sulfide and simultaneously extracted metals in sediments

USGS Publications Warehouse

Brumbaugh, William G.; Arms, Jesse W.

1996-01-01

The determination of acid-volatile sulfide (AVS) and simultaneously extracted metals (SEMs) in sediment by treatment with dilute HCl shows promise as a tool for predicting the potential for metal toxicity to sediment-dwelling organisms. Effective quality control measures must be developed if this method is to become a reliable procedure and to ensure comparability of data. However, establishing quality control measures that assess procedural errors for an operationally defined method can be problematic. For example, preextraction spikes added for assessing the accuracy of AVS and SEMs may be poorly recovered due to adsorption or reaction with sediment constituents. For a variety of sediment types, we found preextraction spikes of sulfide, mercury, and copper to be prone to variable recoveries for the AVS/SEM procedure; recoveries averaged 76.3% (SD, 20.9) for sulfide, 61.9% (39.6) for Hg, and 90.1% (12.7) for Cu. The average recovery was near 100% for preextraction spikes of sediments for Cd, Ni, Pb, and Zn, and the recoveries of preextraction blank spikes for all analytes were consistently 95 to 105%. Binding of Cu or Hg with sulfides is sufficiently strong that 1 N hydrochloric acid will not necessarily keep the spiked metal in the dissolved state. This does not mean that the SEM procedure is invalid for these metals, only that the quality control of procedural error is difficult to assess. However, Hg will generally not be detected when measured as an SEM because of its tendency to adsorb onto sulfide minerals even at extremely low pH. Some reference sediments may be useful for assessing consistency of AVS determinations; we measured 5.97 ± 0.65 μmol/g in National Institute of Standards and Technology (NIST) 1645 and 1.34 ± 0.14 μmol/g in NIST 2704 for repeated determinations conducted over the past 3 years. Apparently, some sediments may contain an oxidation-resistant sulfide component that can release low to moderate AVS when treated with dilute HCl.

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.

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.

Liver phantom for quality control and training in nuclear medicine

NASA Astrophysics Data System (ADS)

Lima Ferreira, Fernanda Carla; Souza, Divanizia do Nascimento

2011-10-01

In nuclear medicine, liver scintigraphy aims to verify organ function based on the radionuclide concentration in the liver and bile flow and is also used to detect tumors. Therefore it is necessary to perform quality control tests in the gamma camera before running the exam to prevent false results. Quality control tests of the gamma camera should thus be performed before running the exam to prevent false results. Such tests generally use radioactive material inside phantoms for evaluation of gamma camera parameters in quality control procedures. Phantoms can also be useful for training doctors and technicians in nuclear medicine procedures. The phantom proposed here has artifacts that simulate nodules; it may take on different quantities, locations and sizes and it may also be mounted without the introduction of nodules. Thus, its images may show hot or cold nodules or no nodules. The phantom consists of acrylic plates hollowed out in the centre, with the geometry of an adult liver. Images for analyses of simulated liver scintigraphy were obtained with the detector device at 5 cm from the anterior surface of the phantom. These simulations showed that this object is suitable for quality control in nuclear medicine because it was possible to visualize artifacts larger than 7.9 mm using a 256×256 matrix and 1000 kcpm. The phantom constructed in this work will also be useful for training practitioners and technicians in order to prevent patients from repeat testing caused by error during examinations.

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.

Data Quality Control of the French Permanent Broadband Network in the RESIF Framework.

NASA Astrophysics Data System (ADS)

Grunberg, M.; Lambotte, S.; Engels, F.

2014-12-01

In the framework of the RESIF (Réseau Sismologique et géodésique Français) project, a new information system is setting up, allowing the improvement of the management and the distribution of high quality data from the different elements of RESIF. Within this information system, EOST (in Strasbourg) is in charge of collecting real-time permanent broadband seismic waveform, and performing Quality Control on these data. The real-time and validated data set are pushed to the French National Distribution Center (Isterre/Grenoble) to make them publicly available. Furthermore EOST hosts the BCSF-ReNaSS, in charge of the French metropolitan seismic bulletin. This allows to benefit from some high-end quality control based on the national and world-wide seismicity. Here we present the real-time seismic data flow from the stations of the French National Broad Band Network to EOST, and then, the data Quality Control procedures that were recently installed, including some new developments.The data Quality Control consists in applying a variety of processes to check the consistency of the whole system from the stations to the data center. This allows us to verify that instruments and data transmission are operating correctly. Moreover, time quality is critical for most of the scientific data applications. To face this challenge and check the consistency of polarities and amplitudes, we deployed several high-end processes including a noise correlation procedure to check for timing accuracy (intrumental time errors result in a time-shift of the whole cross-correlation, clearly distinct from those due to change in medium physical properties), and a systematic comparison of synthetic and real data for teleseismic earthquakes of magnitude larger than 6.5 to detect timing errors as well as polarity and amplitude problems.

Presentation of a quality management program in off-pump coronary bypass surgery.

PubMed

Bougioukakis, Petros; Kluegl, Stefan J; Babin-Ebell, Joerg; Tagarakis, Giorgios I; Mandewirth, Martin; Zacher, Michael; Diegeler, Anno

2014-01-01

To increase the number of off-pump coronary procedures at our institution, a new surgical team was formed. The first 3 years of "learning period" were accompanied by a quality management program aimed to control and adjust the surgical process and to ensure the safety and quality of the procedure. All patients were operated on by the same surgeon between January 2004 and December 2006; all procedures were performed under the following quality management protocol. First, a flow chart regulated surgical and anesthetic details. Second, an online file, named "disturbance file," was used to report work flow interruption, disturbance, and intraoperative events, that is, myocardial ischemia, hypotension, conversion to cardiopulmonary bypass, and any violation of the protocol. Each event was coded with 1 point and added to a score (the higher the score is, the greater the disturbance). Outcome parameters known as major events-major cardiac and cerebral events: mortality within 30 days/myocardial infarction confirmed by electrocardiogram or significantly high levels of total creatine kinase-myocardial muscle creatine kinase/reintervention within 30 days/stroke--and new-onset dialysis were also measured. Success was defined as freedom from any of those events and depicted in a cumulative sum control (CUSUM) chart. Outcome data and CUSUM were correlated with the intraoperative Disturbance Index. In total, 490 off-pump coronary bypass operations were performed by the named surgeon during the study period. The 30-day mortality was reduced from 4.0% to 1.9%. Disturbance Index score of greater than 1 declined from 41.6% to 23.3%. All major cardiac and cerebral events declined. The CUSUM chart showed two critical periods during the learning period, which made an adjustment of the protocol necessary. Quality management control is efficient in improving the postoperative results of a surgical procedure. A learning period is of cardinal importance for any new team wishing to engage in a novel surgical technique.

Quality-assurance plan for the analysis of fluvial sediment by the U.S. Geological Survey Kentucky Water Science Center Sediment Laboratory

USGS Publications Warehouse

Shreve, Elizabeth A.; Downs, Aimee C.

2005-01-01

This report describes laboratory procedures used by the U.S. Geological Survey Kentucky Water Science Center Sediment Laboratory for the processing and analysis of fluvial-sediment samples for concentration of sand and finer material. The report details the processing of a sediment sample through the laboratory from receiving the sediment sample, through the analytical process, to compiling results of the requested analysis. Procedures for preserving sample integrity, calibrating and maintaining of laboratory and field instruments and equipment, analyzing samples, internal quality assurance and quality control, and validity of the sediment-analysis results also are described. The report includes a list of references cited and a glossary of sediment and quality-assurance terms.

Conjoint Analysis for New Service Development on Electricity Distribution in Indonesia

NASA Astrophysics Data System (ADS)

Widaningrum, D. L.; Chynthia; Astuti, L. D.; Seran, M. A. B.

2017-07-01

Many cases of illegal use of electricity in Indonesia is still rampant, especially for activities where the power source is not available, such as in the location of street vendors. It is not only detrimental to the state, but also harm the perpetrators of theft of electricity and the surrounding communities. The purpose of this study is to create New Service Development (NSD) to provide a new electricity source for street vendors' activity based on their preferences. The methods applied in NSD is Conjoint Analysis, Cluster Analysis, Quality Function Deployment (QFD), Service Blueprint, Process Flow Diagrams and Quality Control Plan. The results of this study are the attributes and their importance in the new electricity’s service based on street vendors’ preferences as customers, customer segmentation, service design for new service, designing technical response, designing operational procedures, the quality control plan of any existing operational procedures.

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.

77 FR 46960 - Approval and Promulgation of Air Quality Implementation Plans; Wisconsin; Forest County...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-07

... Promulgation of Air Quality Implementation Plans; Wisconsin; Forest County Potawatomi Community Reservation... approving procedures for permitting certain sources in relation to the Forest County Potawatomi Community...)(2).) List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Carbon...

Use of NDT equipment for construction quality control of hot mix asphalt pavements

DOT National Transportation Integrated Search

2006-08-01

The focus of the study has been to evaluate the utility of seismic methods in the quality management of the hot mix asphalt layers. Procedures are presented to measure the target field moduli of hot mix asphalt (HMA) with laboratory seismic methods, ...

Performance-based quality assurance/quality control (QA/QC) acceptance procedures for in-place soil testing phase 3 : [summary].

DOT National Transportation Integrated Search

2015-01-01

Acceptance of earthwork construction by the Florida Department of Transportation (FDOT) : requires in-place testing conducted with a nuclear density gauge (NDG) to determine : dry density, which must obtain a required percent compaction based upon a ...

77 FR 36137 - Airworthiness Directives; AGUSTA S.p.A. Helicopters

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-18

... the upper end of collective control rod C2 to torque tube C3 is properly installed. This AD is... prevent separation of the collective control rod from the torque tube, loss of control of the collective... helicopters because the production quality control procedures did not require recording the applied torque on...

Radiofrequency Procedures to Relieve Chronic Knee Pain: An Evidence-Based Narrative Review.

PubMed

Bhatia, Anuj; Peng, Philip; Cohen, Steven P

2016-01-01

Chronic knee pain from osteoarthritis or following arthroplasty is a common problem. A number of publications have reported analgesic success of radiofrequency (RF) procedures on nerves innervating the knee, but interpretation is hampered by lack of clarity regarding indications, clinical protocols, targets, and longevity of benefit from RF procedures. We reviewed the following medical literature databases for publications on RF procedures on the knee joint for chronic pain: MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Google Scholar up to August 9, 2015. Data on scores for pain, validated scores for measuring physical disability, and adverse effects measured at any timepoint after 1 month following the interventions were collected, analyzed, and reported in this narrative review. Thirteen publications on ablative or pulsed RF treatments of innervation of the knee joint were identified. A high success rate of these procedures in relieving chronic pain of the knee joint was reported at 1 to 12 months after the procedures, but only 2 of the publications were randomized controlled trials. There was evidence for improvement in function and a lack of serious adverse events of RF treatments. Radiofrequency treatments on the knee joint (major or periarticular nerve supply or intra-articular branches) have the potential to reduce pain from osteoarthritis or persistent postarthroplasty pain. Ongoing concerns regarding the quality, procedural aspects, and monitoring of outcomes in publications on this topic remain. Randomized controlled trials of high methodological quality are required to further elaborate role of these interventions in this population.

Accreditation of Individualized Quality Control Plans by the College of American Pathologists.

PubMed

Hoeltge, Gerald A

2017-03-01

The Laboratory Accreditation Program of the College of American Pathologists (CAP) began in 2015 to allow accredited laboratories to devise their own strategies for quality control of laboratory testing. Participants now have the option to implement individualized quality control plans (IQCPs). Only nonwaived testing that features an internal control (built-in, electronic, or procedural) is eligible for IQCP accreditation. The accreditation checklists that detail the requirements have been peer-reviewed by content experts on CAP's scientific resource committees and by a panel of accreditation participants. Training and communication have been key to the successful introduction of the new IQCP requirements. Copyright © 2016 Elsevier Inc. All rights reserved.

Median of patient results as a tool for assessment of analytical stability.

PubMed

Jørgensen, Lars Mønster; Hansen, Steen Ingemann; Petersen, Per Hyltoft; Sölétormos, György

2015-06-15

In spite of the well-established external quality assessment and proficiency testing surveys of analytical quality performance in laboratory medicine, a simple tool to monitor the long-term analytical stability as a supplement to the internal control procedures is often needed. Patient data from daily internal control schemes was used for monthly appraisal of the analytical stability. This was accomplished by using the monthly medians of patient results to disclose deviations from analytical stability, and by comparing divergences with the quality specifications for allowable analytical bias based on biological variation. Seventy five percent of the twenty analytes achieved on two COBASs INTEGRA 800 instruments performed in accordance with the optimum and with the desirable specifications for bias. Patient results applied in analytical quality performance control procedures are the most reliable sources of material as they represent the genuine substance of the measurements and therefore circumvent the problems associated with non-commutable materials in external assessment. Patient medians in the monthly monitoring of analytical stability in laboratory medicine are an inexpensive, simple and reliable tool to monitor the steadiness of the analytical practice. Copyright © 2015 Elsevier B.V. All rights reserved.

75 FR 4509 - Uniform Criteria for State Observational Surveys of Seat Belt Use

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-28

... establishing the criteria for designing and conducting State seat belt use observational surveys, procedures for obtaining NHTSA approval of survey designs, and a new form for reporting seat belt use rates to.... Assignment of Observation Times D. Observation Procedures E. Quality Control F. Computation of Estimates III...

40 CFR 63.8075 - What reports must I submit and when?

Code of Federal Regulations, 2010 CFR

2010-07-01

... demonstrations to verify that control devices subject to § 63.8000(d)(3) are operating as designed. (3) A... procedures and quality assurance procedures. (iii) Descriptions of monitoring devices, monitoring frequencies...) Identification of the CMS. (J) The date of the latest CMS certification or audit. (K) The operating day or...

Surface electrical properties experiment study phase, volume 3

NASA Technical Reports Server (NTRS)

1973-01-01

The reliability and quality assurance system and procedures used in developing test equipment for the Lunar Experiment projects are described. The subjects discussed include the following: (1) documentation control, (2) design review, (3) parts and materials selection, (4) material procurement, (5) inspection procedures, (6) qualification and special testing, and failure modes and effects analysis.

11 CFR 9405.5 - Categories of exemptions.

Code of Federal Regulations, 2012 CFR

2012-01-01

... descriptions of manufacturing process, quality control methodology, and test results. The following procedures... lawful national security intelligence investigation, information furnished by a confidential source; (v...

11 CFR 9405.5 - Categories of exemptions.

Code of Federal Regulations, 2013 CFR

2013-01-01

... descriptions of manufacturing process, quality control methodology, and test results. The following procedures... lawful national security intelligence investigation, information furnished by a confidential source; (v...

11 CFR 9405.5 - Categories of exemptions.

Code of Federal Regulations, 2011 CFR

2011-01-01

... descriptions of manufacturing process, quality control methodology, and test results. The following procedures... lawful national security intelligence investigation, information furnished by a confidential source; (v...

11 CFR 9405.5 - Categories of exemptions.

Code of Federal Regulations, 2014 CFR

2014-01-01

... descriptions of manufacturing process, quality control methodology, and test results. The following procedures... lawful national security intelligence investigation, information furnished by a confidential source; (v...

Statistical methods for the quality control of steam cured concrete : final report.

DOT National Transportation Integrated Search

1971-01-01

Concrete strength test results from three prestressing plants utilizing steam curing were evaluated statistically in terms of the concrete as received and the effectiveness of the plants' steaming procedures. Control charts were prepared to show tren...

Thyroid and parathyroid imaging

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

Sandler, M.P.; Patton, J.A.; Partain, C.L.

1986-01-01

This book describes the numerous modalities currently used in the diagnosis and treatment of both thyroid and parathyroid disorders. Each modality is fully explained and then evaluated in terms of benefits and limitations in the clinical context. Contents: Production and Quality Control of Radiopharmaceutics Used for Diagnosis and Therapy in Thyroid and Parathyroid Disorders. Basic Physics. Nuclear Instrumentation. Radioimmunoassay: Thyroid Function Tests. Quality Control. Embryology, Anatomy, Physiology, and Thyroid Function Studies. Scintigraphic Thyroid Imaging. Neonatal and Pediatric Thyroid Imaging. Radioiodine Thyroid Uptake Measurement. Radioiodine Treatment of Thyroid Disorders. Radiation Dosimetry of Diagnostic Procedures. Radiation Safety Procedures for High-Level I-131 Therapies.more » X-Ray Fluorescent Scanning. Thyroid Sonography. Computed Tomography in Thyroid Disease. Magnetic Resonance Imaging in Thyroid Disease. Parathyroid Imaging.« less

46 CFR 160.133-9 - Preapproval review.

Code of Federal Regulations, 2012 CFR

2012-10-01

... manual as described in §§ 160.133-19 and 160.133-21 of this subpart; (7) A description of the quality... suppliers; (ii) The method for controlling the inventory of materials; (iii) The method for checking quality of fabrication and joints, including welding inspection procedures; and (iv) The inspection...

46 CFR 160.133-9 - Preapproval review.

Code of Federal Regulations, 2013 CFR

2013-10-01

... manual as described in §§ 160.133-19 and 160.133-21 of this subpart; (7) A description of the quality... suppliers; (ii) The method for controlling the inventory of materials; (iii) The method for checking quality of fabrication and joints, including welding inspection procedures; and (iv) The inspection...

46 CFR 160.170-9 - Preapproval review.

Code of Federal Regulations, 2014 CFR

2014-10-01

... manual as described in §§ 160.170-19 and 160.170-21 of this subpart; (7) A description of the quality... suppliers; (ii) The method for controlling the inventory of materials; (iii) The method for checking quality of fabrication and joints, including welding inspection procedures; and (iv) The inspection...

46 CFR 160.170-9 - Preapproval review.

Code of Federal Regulations, 2013 CFR

2013-10-01

... manual as described in §§ 160.170-19 and 160.170-21 of this subpart; (7) A description of the quality... suppliers; (ii) The method for controlling the inventory of materials; (iii) The method for checking quality of fabrication and joints, including welding inspection procedures; and (iv) The inspection...

46 CFR 160.133-9 - Preapproval review.

Code of Federal Regulations, 2014 CFR

2014-10-01

... manual as described in §§ 160.133-19 and 160.133-21 of this subpart; (7) A description of the quality... suppliers; (ii) The method for controlling the inventory of materials; (iii) The method for checking quality of fabrication and joints, including welding inspection procedures; and (iv) The inspection...

46 CFR 160.170-9 - Preapproval review.

Code of Federal Regulations, 2012 CFR

2012-10-01

... manual as described in §§ 160.170-19 and 160.170-21 of this subpart; (7) A description of the quality... suppliers; (ii) The method for controlling the inventory of materials; (iii) The method for checking quality of fabrication and joints, including welding inspection procedures; and (iv) The inspection...

Performance-based quality assurance/quality control (QA/QC) acceptance procedures for in-place soil testing phase 3.

DOT National Transportation Integrated Search

2015-01-01

One of the objectives of this study was to evaluate soil testing equipment based on its capability of measuring in-place stiffness or modulus values. : As design criteria transition from empirical to mechanistic-empirical, soil test methods and equip...

Water quality data for selected wells in the Coastal Plain of New Jersey, 1996-98

USGS Publications Warehouse

Hibbs, Kathleen L.; Stackelberg, Paul E.; Kauffman, Leon J.; Ayers, Mark A.

2001-01-01

Water-quality data were collected during 1996-98 for 217 wells in New Jersey and 3 wells in New York as part of the U. S. Geological Survey's National Water Quality Assessment Program. Samples were collected for five ground-water surveys that were designed to assess water quality in major aquifer systems, with an emphasis on recently recharged (shallow) ground water associated with present and recent human activities. This report (1) summarizes the hydrogeologic framework in the areas of data collection; (2) describes the objectives and procedures for designing each ground-water survey; (3) summarizes the procedures and protocols for data collec-tion, analysis, and quality control; and (4) lists the concentrations of inorganic constituents, volatile organic compounds, pesticides, nutrients, and trace elements present in the ground-water samples.

Improving Pediatric Basic Life Support Performance Through Blended Learning With Web-Based Virtual Patients: Randomized Controlled Trial.

PubMed

Lehmann, Ronny; Thiessen, Christiane; Frick, Barbara; Bosse, Hans Martin; Nikendei, Christoph; Hoffmann, Georg Friedrich; Tönshoff, Burkhard; Huwendiek, Sören

2015-07-02

E-learning and blended learning approaches gain more and more popularity in emergency medicine curricula. So far, little data is available on the impact of such approaches on procedural learning and skill acquisition and their comparison with traditional approaches. This study investigated the impact of a blended learning approach, including Web-based virtual patients (VPs) and standard pediatric basic life support (PBLS) training, on procedural knowledge, objective performance, and self-assessment. A total of 57 medical students were randomly assigned to an intervention group (n=30) and a control group (n=27). Both groups received paper handouts in preparation of simulation-based PBLS training. The intervention group additionally completed two Web-based VPs with embedded video clips. Measurements were taken at randomization (t0), after the preparation period (t1), and after hands-on training (t2). Clinical decision-making skills and procedural knowledge were assessed at t0 and t1. PBLS performance was scored regarding adherence to the correct algorithm, conformance to temporal demands, and the quality of procedural steps at t1 and t2. Participants' self-assessments were recorded in all three measurements. Procedural knowledge of the intervention group was significantly superior to that of the control group at t1. At t2, the intervention group showed significantly better adherence to the algorithm and temporal demands, and better procedural quality of PBLS in objective measures than did the control group. These aspects differed between the groups even at t1 (after VPs, prior to practical training). Self-assessments differed significantly only at t1 in favor of the intervention group. Training with VPs combined with hands-on training improves PBLS performance as judged by objective measures.

Many roads may lead to Rome: Selected features of quality control within environmental assessment systems in the US, NL, CA, and UK

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

Günther, Markus, E-mail: markus.guenther@tu-berlin.de; Geißler, Gesa; Köppel, Johann

As there is no one-and-only concept on how to precisely define and establish quality control (QC) or quality assurance (QA) in the making of environmental assessments (EA), this paper presents selected features of international approaches that address quality in EA systems in the USA, the Netherlands, Canada, and the United Kingdom. Based on explanative case studies, we highlight the embedding of specific quality control features within the EA systems, the objectives and processes, and relevant transparency challenges. Such features of QC/QA approaches can be considered in cases where substantial quality control and assurance efforts are still missing. Yet further researchmore » needs to be conducted on the efficacy of these approaches, which remains beyond the scope of this study. - Highlights: • We present four tools for quality control and assurance from different EA systems. • Approaches vary in institutional setting, objectives, procedures, and transparency. • Highlighted features might provide guidance in cases where QC/QA is still lacking.« less

Preliminary experience of a PDCA-cycle and quality management based training curriculum for rat liver transplantation.

PubMed

Jin, Hao; Huang, Hai; Dong, Wei; Sun, Jian; Liu, Anding; Deng, Meihong; Dirsch, Olaf; Dahmen, Uta

2012-08-01

As repeatedly operating rat liver transplantation (LTx) until animals survive is inefficient in respect to time and use of living animals, we developed a new training concept. METHODS AND CONCEPTS: Training was divided into four phases: pretraining-phase, basic-microsurgical-training phase, advanced-microsurgical-training phases, and expert-microsurgical-training phase. Two "productivity-phases" were introduced right after the basic- and advanced-microsurgical-training phases, respectively, to allow the trainee to accumulate experience and to be scientifically productive before proceeding to a more complex procedure. PDCA cycles and quality criteria were employed to control the learning-process and the surgical quality. Predefined quality criteria included survival rate, intraoperative, postoperative, and histologic parameters. Three trainees participated in the LTx training and achieved their first survival record within 4-10 operations. All of them completely mastered the LTx in fewer procedures (31, 60 and 26 procedures) as reported elsewhere, and the more complex arterialized or partial LTx were mastered by trainee A and B in additional 9 and 13 procedures, respectively. Fast progress was possible due to a high number of training in the 2 Productivity-phases. The stepwise and PDCA-based training program increased the efficiency of LTx training, whereas the constant application and development of predefined quality criteria guaranteed the quality of microsurgery. Copyright © 2012 Elsevier Inc. All rights reserved.

Aggregative Learning Method and Its Application for Communication Quality Evaluation

NASA Astrophysics Data System (ADS)

Akhmetov, Dauren F.; Kotaki, Minoru

2007-12-01

In this paper, so-called Aggregative Learning Method (ALM) is proposed to improve and simplify the learning and classification abilities of different data processing systems. It provides a universal basis for design and analysis of mathematical models of wide class. A procedure was elaborated for time series model reconstruction and analysis for linear and nonlinear cases. Data approximation accuracy (during learning phase) and data classification quality (during recall phase) are estimated from introduced statistic parameters. The validity and efficiency of the proposed approach have been demonstrated through its application for monitoring of wireless communication quality, namely, for Fixed Wireless Access (FWA) system. Low memory and computation resources were shown to be needed for the procedure realization, especially for data classification (recall) stage. Characterized with high computational efficiency and simple decision making procedure, the derived approaches can be useful for simple and reliable real-time surveillance and control system design.

Quality-assurance plan for the analysis of suspended sediment by the U.S. Geological Survey in Montana

USGS Publications Warehouse

Dodge, Kent A.; Lambing, John H.

2006-01-01

A quality-assurance plan has been developed for use by the sediment laboratory of the U.S. Geological Survey Montana Water Science Center in conducting activities related to the analysis of suspended sediment. The plan documents quality-assurance policies for sediment-laboratory certification, personnel responsibilities and training, documentation requirements, and laboratory safety. The plan also documents quality-assurance procedures related to laboratory equipment and supplies, sample management, sample analysis, analytical quality control, and data management.

Degradation of learned skills: Effectiveness of practice methods on visual approach and landing skill retention

NASA Technical Reports Server (NTRS)

Sitterley, T. E.; Zaitzeff, L. P.; Berge, W. A.

1972-01-01

Flight control and procedural task skill degradation, and the effectiveness of retraining methods were evaluated for a simulated space vehicle approach and landing under instrument and visual flight conditions. Fifteen experienced pilots were trained and then tested after 4 months either without the benefits of practice or with static rehearsal, dynamic rehearsal or with dynamic warmup practice. Performance on both the flight control and procedure tasks degraded significantly after 4 months. The rehearsal methods effectively countered procedure task skill degradation, while dynamic rehearsal or a combination of static rehearsal and dynamic warmup practice was required for the flight control tasks. The quality of the retraining methods appeared to be primarily dependent on the efficiency of visual cue reinforcement.

Specificity of Good Manufacturing Practice (GMP) for Biomedical Cell Products.

PubMed

Tulina, M A; Pyatigorskaya, N V

2018-03-01

The article describes special aspects of Good Manufacturing Practice (GMP) for biomedical cell products (BMCP) that imply high standards of aseptics throughout the entire productio process, strict requirements to donors and to the procedure of biomaterial isolation, guaranty of tracing BMCP products, defining processing procedures which allow to identify BMCP as minimally manipulated; continuous quality control and automation of the control process at all stages of manufacturing, which will ensure product release simultaneously with completion of technological operations.

40 CFR 1051.345 - What production-line testing records must I send to EPA?

Code of Federal Regulations, 2013 CFR

2013-07-01

... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM RECREATIONAL ENGINES AND VEHICLES Testing Production-Line Vehicles and Engines § 1051.345 What production-line testing records must I send to EPA? (a.... We have not changed production processes or quality-control procedures for test engines (or vehicles...

40 CFR 1051.345 - What production-line testing records must I send to EPA?

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM RECREATIONAL ENGINES AND VEHICLES Testing Production-Line Vehicles and Engines § 1051.345 What production-line testing records must I send to EPA? (a.... We have not changed production processes or quality-control procedures for test engines (or vehicles...

40 CFR 1051.345 - What production-line testing records must I send to EPA?

Code of Federal Regulations, 2011 CFR

2011-07-01

... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM RECREATIONAL ENGINES AND VEHICLES Testing Production-Line Vehicles and Engines § 1051.345 What production-line testing records must I send to EPA? (a.... We have not changed production processes or quality-control procedures for test engines (or vehicles...

40 CFR 1051.345 - What production-line testing records must I send to EPA?

Code of Federal Regulations, 2014 CFR

2014-07-01

... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM RECREATIONAL ENGINES AND VEHICLES Testing Production-Line Vehicles and Engines § 1051.345 What production-line testing records must I send to EPA? (a.... We have not changed production processes or quality-control procedures for test engines (or vehicles...

40 CFR 1051.345 - What production-line testing records must I send to EPA?

Code of Federal Regulations, 2012 CFR

2012-07-01

... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM RECREATIONAL ENGINES AND VEHICLES Testing Production-Line Vehicles and Engines § 1051.345 What production-line testing records must I send to EPA? (a.... We have not changed production processes or quality-control procedures for test engines (or vehicles...

Review of nuclear pharmacy practice in hospitals

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

Kawada, T.K.; Tubis, M.; Ebenkamp, T.

1982-02-01

An operational profile for nuclear pharmacy practice is presented, and the technical and professional role of nuclear pharmacists is reviewed. Key aspects of nuclear pharmacy practice in hospitals discussed are the basic facilities and equipment for the preparation, quality control, and distribution of radioactive drug products. Standards for receiving, storing, and processing radioactive material are described. The elements of a radiopharmaceutical quality assurance program, including the working procedures, documentation systems, data analysis, and specific control tests, are presented. Details of dose preparation and administration and systems of inventory control for radioactive products are outlined.

A mixed-methods evaluation of health-related quality of life for male veterans with and without intestinal stomas.

PubMed

Krouse, Robert S; Grant, Marcia; Wendel, Christopher S; Mohler, M Jane; Rawl, Susan M; Baldwin, Carol M; Coons, Stephen Joel; McCorkle, Ruth; Ko, Clifford Y; Schmidt, C Max

2007-12-01

Intestinal stomas have a major impact on Cases' lives. It is essential to better understand the areas in which interventions may help to minimize the negative consequences. This was a case-control survey study using validated instruments (City of Hope Quality of Life-Ostomy and Short Form 36 for Veterans). Cases were accrued from Veterans Affairs Medical Centers in Tucson, Indianapolis, and Los Angeles. Eligibility included a major intra-abdominal surgical procedure that led to an ostomy (cases), or a similar procedure that did not mandate a stoma (controls). Analysis included quantitative and qualitative responses. The response rate was 48 percent (511/1,063). Cases and controls had relatively similar demographic characteristics. Because of low numbers of female respondents (13 cases and 11 controls), only results for males are reported. Based on both the City of Hope Quality of Life-Ostomy and Short Form 36 for Veterans, cases reported significantly poorer scores on scales/domains reflecting psychologic and social functioning and well being. Additionally, cases reported poorer scores on Short Form 36 for Veterans scales reflecting physical functioning and significantly lower scores on multiple items in the social domain of the City of Hope Quality of Life-Ostomy compared with controls. Two-thirds of cases replied to an open-ended question on their "greatest challenge" related to their ostomy, which led to further clarification of major issues. Multiple health-related quality of life problems were reported by male veterans with intestinal stomas. The greatest differences between cases and controls were observed in the social and psychologic domains/scales. Findings from this study provide a greater understanding of the challenges faced by ostomates and will inform the development and evaluation of urgently needed intervention strategies.

32 CFR Appendix A to Part 290 - DCAA's Organization and Mission

Code of Federal Regulations, 2010 CFR

2010-07-01

... established audit quality control standards, policies, and procedures and other internal control requirements... Information Service, 5285 Port Royal Road, Springfield, VA 22161. (c) Objective. Assist in achieving the... provides accounting and financial advisory service regarding contracts to all DoD components responsible...

Nuclear Technology. Course 28: Welding Inspection. Module 28-5, Qualifications.

ERIC Educational Resources Information Center

Espy, John

This fifth in a series of ten modules for a course titled Welding Inspection describes qualification requirements for welding procedures and welders and the role of the nuclear quality assurance/quality control technician. The module follows a typical format that includes the following sections: (1) introduction, (2) module prerequisites, (3)…

40 CFR Appendix B to Part 75 - Quality Assurance and Quality Control Procedures

Code of Federal Regulations, 2011 CFR

2011-07-01

... suitable for inspection. A maintenance log may be used for this purpose. The following records should be... the previous 26 unit (or stack) operating hours; and (b) the 26 clock hour data validation window for... official test log for each monitoring system. (i) The results of any certification, recertification...

Microbiological surveillance and state of the art technological strategies for the prevention of dialysis water pollution.

PubMed

Bolasco, Piergiorgio; Contu, Antonio; Meloni, Patrizia; Vacca, Dorio; Galfrè, Andrea

2012-08-01

The present report attempts to illustrate the positive impact on the microbiological quality of dialysis patients over a 15-year period through the progressive implementation of state-of-the-art technological strategies and the optimization of microbiological surveillance procedures in five dialysis units in Sardinia. Following on better microbiological, quality controls of dialysis water and improvement of procedures and equipment, a drastic improvement of microbiological water quality was observed in a total of 945 samples. The main aim was to introduce the use of microbiological culture methods as recommended by the most important guidelines. The microbiological results obtained have led to a progressive refining of controls and introduction of new materials and equipment, including two-stage osmosis and piping distribution rings featuring a greater capacity to prevent biofilm adhesion. The actions undertaken have resulted in unexpected quality improvements. Dialysis water should be viewed by the nephrologist as a medicinal product exerting a demonstrable positive impact on microinflammation in dialysis patients. A synergic effort between nephrologists and microbiologists undoubtedly constitutes the most effective means of preventing dialysis infections.

Quality assurance and quality control for thermal/optical analysis of aerosol samples for organic and elemental carbon.

PubMed

Chow, Judith C; Watson, John G; Robles, Jerome; Wang, Xiaoliang; Chen, L-W Antony; Trimble, Dana L; Kohl, Steven D; Tropp, Richard J; Fung, Kochy K

2011-12-01

Accurate, precise, and valid organic and elemental carbon (OC and EC, respectively) measurements require more effort than the routine analysis of ambient aerosol and source samples. This paper documents the quality assurance (QA) and quality control (QC) procedures that should be implemented to ensure consistency of OC and EC measurements. Prior to field sampling, the appropriate filter substrate must be selected and tested for sampling effectiveness. Unexposed filters are pre-fired to remove contaminants and acceptance tested. After sampling, filters must be stored in the laboratory in clean, labeled containers under refrigeration (<4 °C) to minimize loss of semi-volatile OC. QA activities include participation in laboratory accreditation programs, external system audits, and interlaboratory comparisons. For thermal/optical carbon analyses, periodic QC tests include calibration of the flame ionization detector with different types of carbon standards, thermogram inspection, replicate analyses, quantification of trace oxygen concentrations (<100 ppmv) in the helium atmosphere, and calibration of the sample temperature sensor. These established QA/QC procedures are applicable to aerosol sampling and analysis for carbon and other chemical components.

Microbiological Surveillance and State of the Art Technological Strategies for the Prevention of Dialysis Water Pollution

PubMed Central

Bolasco, Piergiorgio; Contu, Antonio; Meloni, Patrizia; Vacca, Dorio; Galfrè, Andrea

2012-01-01

Methods: The present report attempts to illustrate the positive impact on the microbiological quality of dialysis patients over a 15-year period through the progressive implementation of state-of-the-art technological strategies and the optimization of microbiological surveillance procedures in five dialysis units in Sardinia. Results: Following on better microbiological, quality controls of dialysis water and improvement of procedures and equipment, a drastic improvement of microbiological water quality was observed in a total of 945 samples. The main aim was to introduce the use of microbiological culture methods as recommended by the most important guidelines. The microbiological results obtained have led to a progressive refining of controls and introduction of new materials and equipment, including two-stage osmosis and piping distribution rings featuring a greater capacity to prevent biofilm adhesion. The actions undertaken have resulted in unexpected quality improvements. Conclusions: Dialysis water should be viewed by the nephrologist as a medicinal product exerting a demonstrable positive impact on microinflammation in dialysis patients. A synergic effort between nephrologists and microbiologists undoubtedly constitutes the most effective means of preventing dialysis infections. PMID:23066395

A procedure for testing the quality of LANDSAT atmospheric correction algorithms

NASA Technical Reports Server (NTRS)

Dias, L. A. V. (Principal Investigator); Vijaykumar, N. L.; Neto, G. C.

1982-01-01

There are two basic methods for testing the quality of an algorithm to minimize atmospheric effects on LANDSAT imagery: (1) test the results a posteriori, using ground truth or control points; (2) use a method based on image data plus estimation of additional ground and/or atmospheric parameters. A procedure based on the second method is described. In order to select the parameters, initially the image contrast is examined for a series of parameter combinations. The contrast improves for better corrections. In addition the correlation coefficient between two subimages, taken at different times, of the same scene is used for parameter's selection. The regions to be correlated should not have changed considerably in time. A few examples using this proposed procedure are presented.

Risk of transmission of sporadic Creutzfeldt-Jakob disease by surgical procedures: systematic reviews and quality of evidence.

PubMed

López, Fernando J García; Ruiz-Tovar, María; Almazán-Isla, Javier; Alcalde-Cabero, Enrique; Calero, Miguel; de Pedro-Cuesta, Jesús

2017-10-01

Sporadic Creutzfeldt-Jakob disease (sCJD) is potentially transmissible to humans. This study aimed to summarise and rate the quality of the evidence of the association between surgery and sCJD. Firstly, we conducted systematic reviews and meta-analyses of case-control studies with major surgical procedures as exposures under study. To assess quality of evidence, we used the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach. Secondly, we conducted a systematic review of sCJD case reports after sharing neurosurgical instruments. Thirteen case-control studies met the inclusion criteria for the systematic review of case-control studies. sCJD was positively associated with heart surgery, heart and vascular surgery and eye surgery, negatively associated with tonsillectomy and appendectomy, and not associated with neurosurgery or unspecified major surgery. The overall quality of evidence was rated as very low. A single case-control study with a low risk of bias found a strong association between surgery conducted more than 20 years before disease onset and sCJD. Seven cases were described as potentially transmitted by reused neurosurgical instruments. The association between surgery and sCJD remains uncertain. Measures currently recommended for preventing sCJD transmission should be strongly maintained. Future studies should focus on the potential association between sCJD and surgery undergone a long time previously.

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2011-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: procedure for adoption of International Chemical Reference Substances; WHO good practices for pharmaceutical microbiology laboratories; good manufacturing practices: main principles for pharmaceutical products; good manufacturing practices for blood establishments (jointly with the Expert Committee on Biological Standardization); guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; good manufacturing practices for sterile pharmaceutical products; guidelines on transfer of technology in pharmaceutical manufacturing; good pharmacy practice: standards for quality of pharmacy services (joint FIP/WHO); model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products (jointly with the Expert Committee on Biological Standardization); procedure for prequalification of pharmaceutical products; guide on submission of documentation for prequalification of innovator finished pharmaceutical products approved by stringent regulatory authorities; prequalification of quality control laboratories: procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies; guidelines for preparing a laboratory information file; guidelines for drafting a site master file; guidelines on submission of documentation for a multisource (generic) finished product: general format: preparation of product dossiers in common technical document format.

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

[Adaptation of the (18)FDG module for the preparation of a sodium fluoride [(18)F] injection solution in agreement with the United States (USP 32) and European Pharmacopeia (PhEur 6)].

PubMed

Martínez, T; Cordero, B; Medín, S; Sánchez Salmón, A

2011-01-01

To establish an automated procedure for the preparation of sodium fluoride (18)F injection using the resources available in our laboratory for the preparation of (18)FDG and to analyze the repercussion of the conditioning column of the fluoride ion entrapment on the characteristics of the final product. The sequence of an (18)FDG synthesis module prepared so that it traps the fluoride ion from the cyclotron in ion-exchange resin diluted with 0.9% sodium chloride. The final solution was dosified and sterilized in a final vial in an automatized dispensing module. Three different column conditioning protocols within the process were tested. Quality controls were run according to USP 32 and EurPh 6, adding control of ethanol levels of residual solvent and quality controls of the solution at 8 h post-preparation. Activation of the resin cartridges with ethanol and water was the chosen procedure, with fluoride ion trapping > 95% and pH around 7. Ethanol levels were < 5.000 ppm. Quality controls at 8 h indicated that the solution was in compliance with the USP 32 and EurPh 6 specifications. This is an easy, low-cost, reliable automated method for sodium fluoride preparation in PET facilities with existing equipment for (18)FDG synthesis and quality control. Copyright © 2010 Elsevier España, S.L. y SEMNIM. All rights reserved.

Audit and internal quality control in immunohistochemistry

PubMed Central

Maxwell, P; McCluggage, W

2000-01-01

Aims—Although positive and negative controls are performed and checked in surgical pathology cases undergoing immunohistochemistry, internal quality control procedures for immunohistochemistry are not well described. This study, comprising a retrospective audit, aims to describe a method of internal quality control for immunohistochemistry. A scoring system that allows comparison between cases is described. Methods—Two positive tissue controls for each month over a three year period (1996–1998) of the 10 antibodies used most frequently were evaluated. All test cases undergoing immunohistochemistry in the months of April in this three year period were also studied. When the test case was completely negative for a given antibody, the corresponding positive tissue control from that day was examined. A marking system was devised whereby each immunohistochemical slide was assessed out of a possible score of 8 to take account of staining intensity, uniformity, specificity, background, and counterstaining. Using this scoring system, cases were classified as showing optimal (7–8), borderline (5–6), or unacceptable (0–4) staining. Results—Most positive tissue controls showed either optimal or borderline staining with the exception of neurone specific enolase (NSE), where most slides were unacceptable or borderline as a result of a combination of low intensity, poor specificity, and excessive background staining. All test cases showed either optimal or borderline staining with the exception of a single case stained for NSE, which was unacceptable. Conclusions—This retrospective audit shows that immunohistochemically stained slides can be assessed using this scoring system. With most antibodies, acceptable staining was achieved in most cases. However, there were problems with staining for NSE, which needs to be reviewed. Laboratories should use a system such as this to evaluate which antibodies regularly result in poor staining so that they can be excluded from panels. Routine evaluation of immunohistochemical staining should become part of everyday internal quality control procedures. Key Words: immunohistochemistry • audit • internal quality control PMID:11265178

Markov Chains For Testing Redundant Software

NASA Technical Reports Server (NTRS)

White, Allan L.; Sjogren, Jon A.

1990-01-01

Preliminary design developed for validation experiment that addresses problems unique to assuring extremely high quality of multiple-version programs in process-control software. Approach takes into account inertia of controlled system in sense it takes more than one failure of control program to cause controlled system to fail. Verification procedure consists of two steps: experimentation (numerical simulation) and computation, with Markov model for each step.

Pain Management for Gynecologic Procedures in the Office.

PubMed

Ireland, Luu Doan; Allen, Rebecca H

2016-02-01

Satisfactory pain control for women undergoing office gynecologic procedures is critical for both patient comfort and procedure success. Therefore, it is important for clinicians to be aware of the safety and efficacy of different pain control regimens. This article aimed to review the literature regarding pain control regimens for procedures such as endometrial biopsy, intrauterine device insertion, colposcopy and loop electrosurgical excisional procedure, uterine aspiration, and hysteroscopy. A search of published literature using PubMed was conducted using the following keywords: "pain" or "anesthesia." These terms were paired with the following keywords: "intrauterine device" or "IUD," "endometrial biopsy," "uterine aspiration" or "abortion," "colposcopy" or "loop electrosurgical excisional procedure" or "LEEP," "hysteroscopy" or "hysteroscopic sterilization." The search was conducted through July 2015. Articles were hand reviewed and selected by the authors for study quality. Meta-analyses and randomized controlled trials were prioritized. Although local anesthesia is commonly used for gynecologic procedures, a multimodal approach may be more effective including oral medication, a dedicated emotional support person, and visual or auditory distraction. Women who are nulliparous, are postmenopausal, have a history of dysmenorrhea, or suffer from anxiety are more likely to experience greater pain with gynecologic procedures. Evidence for some interventions exists; however, the interpretation of intervention comparisons is limited by the use of different regimens, pain measurement scales, patient populations, and procedure techniques. There are many options for pain management for office gynecologic procedures, and depending on the procedure, different modalities may work best. The importance of patient counseling and selection cannot be overstated.

Implementation and application of moving average as continuous analytical quality control instrument demonstrated for 24 routine chemistry assays.

PubMed

Rossum, Huub H van; Kemperman, Hans

2017-07-26

General application of a moving average (MA) as continuous analytical quality control (QC) for routine chemistry assays has failed due to lack of a simple method that allows optimization of MAs. A new method was applied to optimize the MA for routine chemistry and was evaluated in daily practice as continuous analytical QC instrument. MA procedures were optimized using an MA bias detection simulation procedure. Optimization was graphically supported by bias detection curves. Next, all optimal MA procedures that contributed to the quality assurance were run for 100 consecutive days and MA alarms generated during working hours were investigated. Optimized MA procedures were applied for 24 chemistry assays. During this evaluation, 303,871 MA values and 76 MA alarms were generated. Of all alarms, 54 (71%) were generated during office hours. Of these, 41 were further investigated and were caused by ion selective electrode (ISE) failure (1), calibration failure not detected by QC due to improper QC settings (1), possible bias (significant difference with the other analyzer) (10), non-human materials analyzed (2), extreme result(s) of a single patient (2), pre-analytical error (1), no cause identified (20), and no conclusion possible (4). MA was implemented in daily practice as a continuous QC instrument for 24 routine chemistry assays. In our setup when an MA alarm required follow-up, a manageable number of MA alarms was generated that resulted in valuable MA alarms. For the management of MA alarms, several applications/requirements in the MA management software will simplify the use of MA procedures.

Optimizing ACS NSQIP modeling for evaluation of surgical quality and risk: patient risk adjustment, procedure mix adjustment, shrinkage adjustment, and surgical focus.

PubMed

Cohen, Mark E; Ko, Clifford Y; Bilimoria, Karl Y; Zhou, Lynn; Huffman, Kristopher; Wang, Xue; Liu, Yaoming; Kraemer, Kari; Meng, Xiangju; Merkow, Ryan; Chow, Warren; Matel, Brian; Richards, Karen; Hart, Amy J; Dimick, Justin B; Hall, Bruce L

2013-08-01

The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) collects detailed clinical data from participating hospitals using standardized data definitions, analyzes these data, and provides participating hospitals with reports that permit risk-adjusted comparisons with a surgical quality standard. Since its inception, the ACS NSQIP has worked to refine surgical outcomes measurements and enhance statistical methods to improve the reliability and validity of this hospital profiling. From an original focus on controlling for between-hospital differences in patient risk factors with logistic regression, ACS NSQIP has added a variable to better adjust for the complexity and risk profile of surgical procedures (procedure mix adjustment) and stabilized estimates derived from small samples by using a hierarchical model with shrinkage adjustment. New models have been developed focusing on specific surgical procedures (eg, "Procedure Targeted" models), which provide opportunities to incorporate indication and other procedure-specific variables and outcomes to improve risk adjustment. In addition, comparative benchmark reports given to participating hospitals have been expanded considerably to allow more detailed evaluations of performance. Finally, procedures have been developed to estimate surgical risk for individual patients. This article describes the development of, and justification for, these new statistical methods and reporting strategies in ACS NSQIP. Copyright © 2013 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

14 CFR 21.143 - Quality control data requirements; prime manufacturer.

Code of Federal Regulations, 2010 CFR

2010-01-01

..., purchased items, and parts and assemblies produced by manufacturers' suppliers including methods used to... special manufacturing processes involved, the means used to control the processes, the final test... procedure for recording review board decisions and disposing of rejected parts; (5) An outline of a system...

[Recommendations for inspections of the French nuclear safety authority].

PubMed

Rousse, C; Chauvet, B

2015-10-01

The French nuclear safety authority is responsible for the control of radiation protection in radiotherapy since 2002. Controls are based on the public health and the labour codes and on the procedures defined by the controlled health care facility for its quality and safety management system according to ASN decision No. 2008-DC-0103. Inspectors verify the adequacy of the quality and safety management procedures and their implementation, and select process steps on the basis of feedback from events notified to ASN. Topics of the inspection are communicated to the facility at the launch of a campaign, which enables them to anticipate the inspectors' expectations. In cases where they are not physicians, inspectors are not allowed to access information covered by medical confidentiality. The consulted documents must therefore be expunged of any patient-identifying information. Exchanges before the inspection are intended to facilitate the provision of documents that may be consulted. Finally, exchange slots between inspectors and the local professionals must be organized. Based on improvements achieved by the health care centres and on recommendations from a joint working group of radiotherapy professionals and the nuclear safety authority, changes will be made in the control procedure that will be implemented when developing the inspection program for 2016-2019. Copyright © 2015. Published by Elsevier SAS.

Physical Property Analysis and Report for Sediments at 100-BC-5 Operable Unit, Boreholes C7505, C7506, C7507, and C7665

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

Lindberg, Michael J.

2010-09-28

Between October 14, 2009 and February 22, 2010 sediment samples were received from 100-BC Decision Unit for geochemical studies. This is an analytical data report for sediments received from CHPRC at the 100 BC 5 OU. The analyses for this project were performed at the 325 building located in the 300 Area of the Hanford Site. The analyses were performed according to Pacific Northwest National Laboratory (PNNL) approved procedures and/or nationally recognized test procedures. The data sets include the sample identification numbers, analytical results, estimated quantification limits (EQL), and quality control data. The preparatory and analytical quality control requirements, calibrationmore » requirements, acceptance criteria, and failure actions are defined in the on-line QA plan 'Conducting Analytical Work in Support of Regulatory Programs' (CAW). This QA plan implements the Hanford Analytical Services Quality Assurance Requirements Documents (HASQARD) for PNNL.« less

The introduction of local air quality management in the United Kingdom: A review and theoretical framework

NASA Astrophysics Data System (ADS)

Longhurst, J. W. S.; Lindley, S. J.; Watson, A. F. R.; Conlan, D. E.

In the light of recent episodes of poor air quality in many of the U.K.'s major urban areas, concern has been expressed regarding the apparent inability of existing air quality control procedures to effectively tackle contemporary scenarios. As a result of this, a new philosophy for air quality control has been sought which can provide a solid basis for the preservation and future improvement of air quality. It is proposed that a suitable mechanism for this would be found through the adoption of an integrated and holistic local air quality management approach. This paper will present and discuss a theoretical framework for the application of local air quality management in the U.K. and investigate the potential of the Environment Act (1995) to provide such a framework.

40 CFR 1054.345 - What production-line testing records must I send to EPA?

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM NEW, SMALL NONROAD SPARK-IGNITION ENGINES AND... 1054. We have not changed production processes or quality-control procedures for test engines in a way...) Describe any facility used to test production-line engines and state its location. (2) State the total U.S...

40 CFR 1054.345 - What production-line testing records must I send to EPA?

Code of Federal Regulations, 2011 CFR

2011-07-01

... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM NEW, SMALL NONROAD SPARK-IGNITION ENGINES AND... 1054. We have not changed production processes or quality-control procedures for test engines in a way...) Describe any facility used to test production-line engines and state its location. (2) State the total U.S...

40 CFR 1054.345 - What production-line testing records must I send to EPA?

Code of Federal Regulations, 2014 CFR

2014-07-01

... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM NEW, SMALL NONROAD SPARK-IGNITION ENGINES AND... 1054. We have not changed production processes or quality-control procedures for test engines in a way...) Describe any facility used to test production-line engines and state its location. (2) State the total U.S...

40 CFR 1054.345 - What production-line testing records must I send to EPA?

Code of Federal Regulations, 2012 CFR

2012-07-01

... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM NEW, SMALL NONROAD SPARK-IGNITION ENGINES AND... 1054. We have not changed production processes or quality-control procedures for test engines in a way...) Describe any facility used to test production-line engines and state its location. (2) State the total U.S...

40 CFR 1054.345 - What production-line testing records must I send to EPA?

Code of Federal Regulations, 2013 CFR

2013-07-01

... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM NEW, SMALL NONROAD SPARK-IGNITION ENGINES AND... 1054. We have not changed production processes or quality-control procedures for test engines in a way...) Describe any facility used to test production-line engines and state its location. (2) State the total U.S...

[Education for patients with fibromyalgia. A systematic review of randomised clinical trials].

PubMed

Elizagaray-Garcia, Ignacio; Muriente-Gonzalez, Jorge; Gil-Martinez, Alfonso

2016-01-16

To analyse the effectiveness of education about pain, quality of life and functionality in patients with fibromyalgia. The search for articles was carried out in electronic databases. Eligibility criteria were: controlled randomised clinical trials (RCT), published in English and Spanish, that had been conducted on patients with fibromyalgia, in which the therapeutic procedure was based on patient education. Two independent reviewers analysed the methodological quality using the PEDro scale. Five RCT were selected, of which four offered good methodological quality. In three of the studies, patient education, in combination with another intervention based on therapeutic exercise, improved the outcomes in the variables assessing pain and quality of life as compared with the same procedures performed separately. Moreover, an RCT with a high quality methodology showed that patient education activated inhibitory neural pathways capable of lowering the level of pain. The quantitative analysis yields strong-moderate evidence that patient education, in combination with other therapeutic exercise procedures, offers positive results in the variables pain, quality of life and functionality. Patient education in itself has not proved to be effective for pain, quality of life or functionality in patients with fibromyalgia. There is strong evidence, however, of the effectiveness of combining patient education with exercise and active strategies for coping with pain, quality of life and functionality in the short, medium and long term in patients with fibromyalgia.

Quality of life before and after cosmetic surgery.

PubMed

Bensoussan, Jean-Charles; Bolton, Michael A; Pi, Sarah; Powell-Hicks, Allycin L; Postolova, Anna; Razani, Bahram; Reyes, Kevin; IsHak, Waguih William

2014-08-01

This article reviews the literature regarding the impact of cosmetic surgery on health-related quality of life (QOL). Studies were identified through PubMed/Medline and PsycINFO searches from January 1960 to December 2011. Twenty-eight studies were included in this review, according to specific selection criteria. The procedures and tools employed in cosmetic surgery research studies were remarkably diverse, thus yielding difficulties with data analysis. However, data indicate that individuals undergoing cosmetic surgery began with lower values on aspects of QOL than control subjects, and experienced significant QOL improvement post-procedurally, an effect that appeared to plateau with time. Despite the complexity of measuring QOL in cosmetic surgery patients, most studies showed an improvement in QOL after cosmetic surgery procedures. However, this finding was clouded by measurement precision as well as heterogeneity of procedures and study populations. Future research needs to focus on refining measurement techniques, including developing cosmetic surgery-specific QOL measures.

The World Optical Depth Research and Calibration Center (WORCC) quality assurance and quality control of GAW-PFR AOD measurements

NASA Astrophysics Data System (ADS)

Kazadzis, Stelios; Kouremeti, Natalia; Nyeki, Stephan; Gröbner, Julian; Wehrli, Christoph

2018-02-01

The World Optical Depth Research Calibration Center (WORCC) is a section within the World Radiation Center at Physikalisches-Meteorologisches Observatorium (PMOD/WRC), Davos, Switzerland, established after the recommendations of the World Meteorological Organization for calibration of aerosol optical depth (AOD)-related Sun photometers. WORCC is mandated to develop new methods for instrument calibration, to initiate homogenization activities among different AOD networks and to run a network (GAW-PFR) of Sun photometers. In this work we describe the calibration hierarchy and methods used under WORCC and the basic procedures, tests and processing techniques in order to ensure the quality assurance and quality control of the AOD-retrieved data.

A design procedure for the handling qualities optimization of the X-29A aircraft

NASA Technical Reports Server (NTRS)

Bosworth, John T.; Cox, Timothy H.

1989-01-01

A design technique for handling qualities improvement was developed for the X-29A aircraft. As with any new aircraft, the X-29A control law designers were presented with a relatively high degree of uncertainty in their mathematical models. The presence of uncertainties, and the high level of static instability of the X-29A caused the control law designers to stress stability and robustness over handling qualities. During flight test, the mathematical models of the vehicle were validated or corrected to match the vehicle dynamic behavior. The updated models were then used to fine tune the control system to provide fighter-like handling characteristics. A design methodology was developed which works within the existing control system architecture to provide improved handling qualities and acceptable stability with a minimum of cost in both implementation as well as software verification and validation.

Quality in the Basic Grant Delivery System: Volume 2, Corrective Actions.

ERIC Educational Resources Information Center

Advanced Technology, Inc., McLean, VA.

Alternative management procedures are recommended that may lower the rate and magnitude of errors in the award of the Basic Educational Opportunity Grants (BEOGs), or Pell Grants. The recommendations are part of the BEOG quality control project and are based on a review of current (1980-1981) levels, distribution, and significance of error in the…

Learner's Guide: Water Quality Monitoring. An Instructional Guide for the Two-Year Water Quality Monitoring Curriculum.

ERIC Educational Resources Information Center

Glazer, Richard B.; And Others

This learner's guide is designed to meet the training needs for technicians involved in monitoring activities related to the Federal Water Pollution Act and the Safe Drinking Water Act. In addition it will assist technicians in learning how to perform process control laboratory procedures for drinking water and wastewater treatment plant…

40 CFR 97.172 - Out of control periods.

Code of Federal Regulations, 2010 CFR

2010-07-01

... quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or subpart H of, or appendix D or... monitoring system. The data measured and recorded by the monitoring system shall not be considered valid...

40 CFR 97.372 - Out of control periods.

Code of Federal Regulations, 2014 CFR

2014-07-01

... quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or subpart H of, or appendix D or... monitoring system. The data measured and recorded by the monitoring system shall not be considered valid...

40 CFR 97.172 - Out of control periods.

Code of Federal Regulations, 2013 CFR

2013-07-01

... quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or subpart H of, or appendix D or... monitoring system. The data measured and recorded by the monitoring system shall not be considered valid...

40 CFR 97.272 - Out of control periods.

Code of Federal Regulations, 2011 CFR

2011-07-01

... quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D of appendix D to part 75 of this chapter... prospectively the certification status of the monitoring system. The data measured and recorded by the...

40 CFR 97.172 - Out of control periods.

Code of Federal Regulations, 2014 CFR

2014-07-01

... quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or subpart H of, or appendix D or... monitoring system. The data measured and recorded by the monitoring system shall not be considered valid...

40 CFR 97.272 - Out of control periods.

Code of Federal Regulations, 2014 CFR

2014-07-01

... quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D of appendix D to part 75 of this chapter... prospectively the certification status of the monitoring system. The data measured and recorded by the...

40 CFR 97.172 - Out of control periods.

Code of Federal Regulations, 2011 CFR

2011-07-01

... quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or subpart H of, or appendix D or... monitoring system. The data measured and recorded by the monitoring system shall not be considered valid...

40 CFR 97.272 - Out of control periods.

Code of Federal Regulations, 2012 CFR

2012-07-01

... quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D of appendix D to part 75 of this chapter... prospectively the certification status of the monitoring system. The data measured and recorded by the...

40 CFR 97.172 - Out of control periods.

Code of Federal Regulations, 2012 CFR

2012-07-01

... quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or subpart H of, or appendix D or... monitoring system. The data measured and recorded by the monitoring system shall not be considered valid...

40 CFR 97.272 - Out of control periods.

Code of Federal Regulations, 2010 CFR

2010-07-01

... quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D of appendix D to part 75 of this chapter... prospectively the certification status of the monitoring system. The data measured and recorded by the...

40 CFR 97.272 - Out of control periods.

Code of Federal Regulations, 2013 CFR

2013-07-01

... quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D of appendix D to part 75 of this chapter... prospectively the certification status of the monitoring system. The data measured and recorded by the...

40 CFR 97.372 - Out of control periods.

Code of Federal Regulations, 2013 CFR

2013-07-01

... quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or subpart H of, or appendix D or... monitoring system. The data measured and recorded by the monitoring system shall not be considered valid...

40 CFR 97.372 - Out of control periods.

Code of Federal Regulations, 2010 CFR

2010-07-01

... quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or subpart H of, or appendix D or... monitoring system. The data measured and recorded by the monitoring system shall not be considered valid...

40 CFR 97.372 - Out of control periods.

Code of Federal Regulations, 2011 CFR

2011-07-01

... quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or subpart H of, or appendix D or... monitoring system. The data measured and recorded by the monitoring system shall not be considered valid...

40 CFR 97.372 - Out of control periods.

Code of Federal Regulations, 2012 CFR

2012-07-01

... quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or subpart H of, or appendix D or... monitoring system. The data measured and recorded by the monitoring system shall not be considered valid...

10 CFR 26.125 - Licensee testing facility personnel.

Code of Federal Regulations, 2013 CFR

2013-01-01

..., medical technology, or equivalent. He or she shall also have training and experience in the theory and... control practices and procedures, the review, interpretation, and reporting of test results, and proper remedial actions to be taken in response to detection of abnormal test or quality control results. (b...

10 CFR 26.125 - Licensee testing facility personnel.

Code of Federal Regulations, 2012 CFR

2012-01-01

..., medical technology, or equivalent. He or she shall also have training and experience in the theory and... control practices and procedures, the review, interpretation, and reporting of test results, and proper remedial actions to be taken in response to detection of abnormal test or quality control results. (b...

10 CFR 26.125 - Licensee testing facility personnel.

Code of Federal Regulations, 2014 CFR

2014-01-01

..., medical technology, or equivalent. He or she shall also have training and experience in the theory and... control practices and procedures, the review, interpretation, and reporting of test results, and proper remedial actions to be taken in response to detection of abnormal test or quality control results. (b...

10 CFR 26.125 - Licensee testing facility personnel.

Code of Federal Regulations, 2011 CFR

2011-01-01

..., medical technology, or equivalent. He or she shall also have training and experience in the theory and... control practices and procedures, the review, interpretation, and reporting of test results, and proper remedial actions to be taken in response to detection of abnormal test or quality control results. (b...

10 CFR 26.125 - Licensee testing facility personnel.

Code of Federal Regulations, 2010 CFR

2010-01-01

..., medical technology, or equivalent. He or she shall also have training and experience in the theory and... control practices and procedures, the review, interpretation, and reporting of test results, and proper remedial actions to be taken in response to detection of abnormal test or quality control results. (b...

Video on Diet Before Outpatient Colonoscopy Does Not Improve Quality of Bowel Preparation: A Prospective, Randomized, Controlled Trial.

PubMed

Rice, Sean C; Higginbotham, Tina; Dean, Melanie J; Slaughter, James C; Yachimski, Patrick S; Obstein, Keith L

2016-11-01

Successful outpatient colonoscopy (CLS) depends on many factors including the quality of a patient's bowel preparation. Although education on consumption of the pre-CLS purgative can improve bowel preparation quality, no study has evaluated dietary education alone. We have created an educational video on pre-CLS dietary instructions to determine whether dietary education would improve outpatient bowel preparation quality. A prospective randomized, blinded, controlled study of patients undergoing outpatient CLS was performed. All patients received a 4 l polyethylene glycol-based split-dose bowel preparation and standard institutional pre-procedure instructions. Patients were then randomly assigned to an intervention arm or to a no intervention arm. A 4-min educational video detailing clear liquid diet restriction was made available to patients in the intervention arm, whereas those randomized to no intervention did not have access to the video. Patients randomized to the video were provided with the YouTube video link 48-72 h before CLS. An attending endoscopist blinded to randomization performed the CLS. Bowel preparation quality was scored using the Boston Bowel Preparation Scale (BBPS). Adequate preparation was defined as a BBPS total score of ≥6 with all segment scores ≥2. Wilcoxon rank-sum and Pearson's χ 2 -tests were performed to assess differences between groups. Ninety-two patients were randomized (video: n=42; control: n=50) with 47 total video views being tallied. There were no demographic differences between groups. There was no statistically significant difference in adequate preparation between groups (video=74%; control=68%; P=0.54). The availability of a supplementary patient educational video on clear liquid diet alone was insufficient to improve bowel preparation quality when compared with standard pre-procedure instruction at our institution.

A Quality-Control-Oriented Database for a Mesoscale Meteorological Observation Network

NASA Astrophysics Data System (ADS)

Lussana, C.; Ranci, M.; Uboldi, F.

2012-04-01

In the operational context of a local weather service, data accessibility and quality related issues must be managed by taking into account a wide set of user needs. This work describes the structure and the operational choices made for the operational implementation of a database system storing data from highly automated observing stations, metadata and information on data quality. Lombardy's environmental protection agency, ARPA Lombardia, manages a highly automated mesoscale meteorological network. A Quality Assurance System (QAS) ensures that reliable observational information is collected and disseminated to the users. The weather unit in ARPA Lombardia, at the same time an important QAS component and an intensive data user, has developed a database specifically aimed to: 1) providing quick access to data for operational activities and 2) ensuring data quality for real-time applications, by means of an Automatic Data Quality Control (ADQC) procedure. Quantities stored in the archive include hourly aggregated observations of: precipitation amount, temperature, wind, relative humidity, pressure, global and net solar radiation. The ADQC performs several independent tests on raw data and compares their results in a decision-making procedure. An important ADQC component is the Spatial Consistency Test based on Optimal Interpolation. Interpolated and Cross-Validation analysis values are also stored in the database, providing further information to human operators and useful estimates in case of missing data. The technical solution adopted is based on a LAMP (Linux, Apache, MySQL and Php) system, constituting an open source environment suitable for both development and operational practice. The ADQC procedure itself is performed by R scripts directly interacting with the MySQL database. Users and network managers can access the database by using a set of web-based Php applications.

How much image noise can be added in cardiac x-ray imaging without loss in perceived image quality?

NASA Astrophysics Data System (ADS)

Gislason-Lee, Amber J.; Kumcu, Asli; Kengyelics, Stephen M.; Rhodes, Laura A.; Davies, Andrew G.

2015-03-01

Dynamic X-ray imaging systems are used for interventional cardiac procedures to treat coronary heart disease. X-ray settings are controlled automatically by specially-designed X-ray dose control mechanisms whose role is to ensure an adequate level of image quality is maintained with an acceptable radiation dose to the patient. Current commonplace dose control designs quantify image quality by performing a simple technical measurement directly from the image. However, the utility of cardiac X-ray images is in their interpretation by a cardiologist during an interventional procedure, rather than in a technical measurement. With the long term goal of devising a clinically-relevant image quality metric for an intelligent dose control system, we aim to investigate the relationship of image noise with clinical professionals' perception of dynamic image sequences. Computer-generated noise was added, in incremental amounts, to angiograms of five different patients selected to represent the range of adult cardiac patient sizes. A two alternative forced choice staircase experiment was used to determine the amount of noise which can be added to a patient image sequences without changing image quality as perceived by clinical professionals. Twenty-five viewing sessions (five for each patient) were completed by thirteen observers. Results demonstrated scope to increase the noise of cardiac X-ray images by up to 21% +/- 8% before it is noticeable by clinical professionals. This indicates a potential for 21% radiation dose reduction since X-ray image noise and radiation dose are directly related; this would be beneficial to both patients and personnel.

The importance of a two-step impression procedure for complete denture fabrication: a systematic review of the literature.

PubMed

Regis, R R; Alves, C C S; Rocha, S S M; Negreiros, W A; Freitas-Pontes, K M

2016-10-01

The literature has questioned the real need for some clinical and laboratory procedures considered essential for achieving better results for complete denture fabrication. The aim of this study was to review the current literature concerning the relevance of a two-step impression procedure to achieve better clinical results in fabricating conventional complete dentures. Through an electronic search strategy of the PubMed/MEDLINE database, randomised controlled clinical trials which compared complete denture fabrication in adults in which one or two steps of impressions occurred were identified. The selections were made by three independent reviewers. Among the 540 titles initially identified, four studies (seven published papers) reporting on 257 patients evaluating aspects such as oral health-related quality of life, patient satisfaction with dentures in use, masticatory performance and chewing ability, denture quality, direct and indirect costs were considered eligible. The quality of included studies was assessed according to the Cochrane guidelines. The clinical studies considered for this review suggest that a two-step impression procedure may not be mandatory for the success of conventional complete denture fabrication regarding a variety of clinical aspects of denture quality and patients' perceptions of the treatment. © 2016 John Wiley & Sons Ltd.

Strengthening radiopharmacy practice in IAEA Member States.

PubMed

Duatti, Adriano; Bhonsle, Uday

2013-05-01

Radiopharmaceuticals are essential components of nuclear medicine procedures. Without radiopharmaceuticals nuclear medicine procedures cannot be performed. Therefore it could be said that 'No radiopharmaceutical-no nuclear medicine.' A good radiopharmacy practice supports nuclear medicine activities by producing radiopharmaceuticals that are safe and are of the required quality in a consistent way. As with any medicinal product, radiopharmaceuticals are required to be produced under carefully controlled conditions and are tested for their quality, prior to the administration to patients, using validated standard operating procedures. These procedures are based on the principles of Good Manufacturing Practice (GMP). The GMP principles are based on scientific knowledge and applicable regulatory requirements and guidance related to radiopharmaceutical productions and use. The International Atomic Energy Agency (IAEA) is committed to promote, in the Member States (MS), a rational and practical approach for the implementation of GMP for compounding or manufacturing of diagnostic or therapeutic radiopharmaceuticals. To pursue this goal the IAEA has developed various mechanisms and collaborations with individual experts in the field and with relevant national and international institutions or organizations. IAEA's activities in promoting radiopharmaceutical science include commissioning expert advice in the form of publications on radiopharmaceutical production, quality control and usage, producing technical guidance on production and regulatory aspects related to new radiopharmaceuticals, creating guidance documentation for self or internal audits of radiopharmaceutical production facilities, producing guidance on implementation of Quality Management System and GMP in radiopharmacy, assisting in creation of specific radiopharmaceutical monographs for the International Pharmacopoeia, and developing radiopharmacy-related human resource capabilities in MS through individual and regional training courses and education programs. IAEA strongly supports development of clinical nuclear medicine services by assisting MS in setting up reliable Radiopharmaceutical production facilities for single photon emission computed tomography, positron emission tomography, and for therapeutic applications. Copyright © 2013 Elsevier Inc. All rights reserved.

Rubber dam isolation of cervical lesions. Part 1: Alternative techniques which avoid injury to the periodontium.

PubMed

Liebenberg, W H

1994-01-01

While it is arguable that the operative procedures depicted in this article could have been done equally well with alternative forms of isolation, it is indisputable that rubber dam provides for the most thorough 'isolation' in the comprehensive sense of the term. It allows for the finite control over peripheral variables such as access and controlled gingival retraction. This in turn permits meticulous execution of restorative procedures within the luxury of 'true four-handed dentistry'. Most operative procedures are done within the limitations of single handed dentistry as the other 'three hands' are involved with retraction, fluid evacuation and access control. The rubber dam is indeed indispensable and with the increased awareness of infection control it is conceivable that rubber dam isolation will continue to be associated with quality patient care. Part 2 of this article will detail the application of the 'Modified Gingival Retractor' in the isolation of cervical lesions.

[What is the methodological quality of articles on therapeutic procedures published in Cirugía Española?].

PubMed

Manterola, Carlos; Busquets, Juli; Pascual, Marta; Grande, Luis

2006-02-01

The aim of this study was to determine the methodological quality of articles on therapeutic procedures published in Cirugía Española and to study its association with the publication year, center, and subject-matter. A bibliometric study that included all articles on therapeutic procedures published in Cirugía Española between 2001 and 2004 was performed. All kinds of clinical designs were considered, excluding editorials, review articles, letters to editor, and experimental studies. The variables analyzed were: year of publication, center, design, and methodological quality. Methodological quality was determined by a valid and reliable scale. Descriptive statistics (calculation of means, standard deviation and medians) and analytical statistics (Pearson's chi2, nonparametric, ANOVA and Bonferroni tests) were used. A total of 244 articles were studied (197 case series [81%], 28 cohort studies [12%], 17 clinical trials [7%], 1 cross sectional study and 1 case-control study [0.8%]). The studies were performed mainly in Catalonia and Murcia (22% and 16%, respectively). The most frequent subject areas were soft tissue and hepatobiliopancreatic surgery (23% and 19%, respectively). The mean and median of the methodological quality score calculated for the entire series was 10.2 +/- 3.9 points and 9.5 points, respectively. Methodological quality significantly increased by publication year (p < 0.001). An association between methodological quality and subject area was observed but no association was detected with the center performing the study. The methodological quality of articles on therapeutic procedures published in Cirugía Española between 2001 and 2004 is low. However, a statistically significant trend toward improvement was observed.

Effects of modifying the World Health Organization standard operating procedures for malaria microscopy to improve surveillance in resource poor settings.

PubMed

Fernando, Sumadhya D; Ihalamulla, Ratnasiri L; Wickremasinghe, Renu; de Silva, Nipun L; Thilakarathne, Janani H; Wijeyaratne, Pandu; Premaratne, Risintha G

2014-03-15

Individuals with fever are screened for malaria in specially-established malaria diagnostic laboratories set up in rural hospitals in the Northern and Eastern Provinces of Sri Lanka. Large numbers of blood smears negative for malaria parasites are being screened daily. Good quality smears are essential to maintain a high diagnostic competency among the technical staff. The modifications made to the World Health Organization (WHO) standard operating procedures to improve the quality of smears have been studied. A blinded, controlled, interventional study was conducted in 22 intervention and 21 control malaria diagnostic laboratories. Changes were made to the WHO standard operating procedure protocols to prepare, stain and examine blood smears for malaria parasite detection which were implemented in intervention laboratories. These included wipe-cleaning slides, preparing both thick and thin smears on the same slide, reversing the order of collecting blood for thick and thin smears, dry fixing thick smear for 20-25 minutes under table lamp, polishing the edge of spreader slide with sand paper and fixing the thin smear with methanol if not stained within four hours. Parameters with respect to quality of the smear as per WHO criteria were studied using randomly selected slides, and time taken for the report to be issued was recorded in both groups before and after the intervention. There were no significant differences observed in the parameters studied at baseline between the two groups or pre and post intervention in the control group. In the intervention group streak formation in thin smears was reduced from 29.4% to 5.0%. The average fixing time of thick smears was reduced from 2.4 hours to 20 minutes. Inappropriate thickness of thick smears reduced from 18.3% to 1.5%. Overall quality of thick smears and thin smears increased from 76.1% to 98.0% and 81.7% to 87.0%, respectively. The quality of slides bearing both thick and thin smears increased from 60.0% to 87.0%. New protocols with amendments to the WHO standard technical procedures ensure that good quality blood smears are prepared rapidly to diagnose malaria and the time required to issue the reports was reduced.

Biobanking of CSF: international standardization to optimize biomarker development.

PubMed

Teunissen, Charlotte E; Tumani, Hayrettin; Engelborghs, Sebastiaan; Mollenhauer, Brit

2014-03-01

Cerebrospinal fluid (CSF) reflects pathophysiological aspects of neurological diseases, where neuroprotective strategies and biomarkers are urgently needed. Therefore, biobanking is very relevant for biomarker discovery and evaluation of neurological diseases. Important and unique features of CSF biobanking are intensive collaboration in international networks and the tight application of standardized protocols. The current adoption of standardized protocols for CSF and blood collection as presented in this review enables biomarker studies in large cohorts of patients and controls. Another topic of this review is the selection of control groups, which influences the outcome of biomarker investigations. Control groups in CSF biobanks mainly consist of different disease controls. This is in part due to the fact that lumbar punctures are mostly performed for clinical indications and rarely for research purposes only, as it is a relatively invasive procedure. Moreover, there is a lack of homogenous criteria and definition of control groups. We therefore propose uniform consensus definitions for such control groups in biomarker research, i.e. Healthy controls (HC), Spinal anesthesia subjects (SAS), Symptomatic controls (SC), Inflammatory Neurological Disease Controls (CINDC), Peripheral Inflammatory Neurological Disease Controls (PINDC) and Non-inflammatory Neurological Disease Controls (NINDC). Another important aspect of CSF biobanking is quality control. Systematic studies to address effects of pre-analytical and storage variation on a broad range of CSF proteins are needed. In conclusion, biomarker research in neurodegenerative diseases has entered a new era due to the collaborative and multicenter efforts of many groups. The streamlining of biobanking procedures, including quality control, and the selection of optimal control groups for investigating biomarkers are important improvements to perform high quality biomarker studies. Copyright © 2014 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

77 FR 3389 - Approval and Promulgation of State Air Quality Plans for Designated Facilities and Pollutants...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-24

... regulates a mixture of air pollutants including organics (dioxins/furans), carbon monoxide, metals (cadmium... procedure, Air pollution control, Aluminum, Fertilizers, Fluoride, Intergovernmental relations, Paper and...

10 CFR 35.290 - Training for imaging and localization studies.

Code of Federal Regulations, 2010 CFR

2010-01-01

..., at a minimum— (i) Classroom and laboratory training in the following areas— (A) Radiation physics and...) Performing quality control procedures on instruments used to determine the activity of dosages and performing...

Quality Control of Structural MRI Images Applied Using FreeSurfer—A Hands-On Workflow to Rate Motion Artifacts

PubMed Central

Backhausen, Lea L.; Herting, Megan M.; Buse, Judith; Roessner, Veit; Smolka, Michael N.; Vetter, Nora C.

2016-01-01

In structural magnetic resonance imaging motion artifacts are common, especially when not scanning healthy young adults. It has been shown that motion affects the analysis with automated image-processing techniques (e.g., FreeSurfer). This can bias results. Several developmental and adult studies have found reduced volume and thickness of gray matter due to motion artifacts. Thus, quality control is necessary in order to ensure an acceptable level of quality and to define exclusion criteria of images (i.e., determine participants with most severe artifacts). However, information about the quality control workflow and image exclusion procedure is largely lacking in the current literature and the existing rating systems differ. Here, we propose a stringent workflow of quality control steps during and after acquisition of T1-weighted images, which enables researchers dealing with populations that are typically affected by motion artifacts to enhance data quality and maximize sample sizes. As an underlying aim we established a thorough quality control rating system for T1-weighted images and applied it to the analysis of developmental clinical data using the automated processing pipeline FreeSurfer. This hands-on workflow and quality control rating system will aid researchers in minimizing motion artifacts in the final data set, and therefore enhance the quality of structural magnetic resonance imaging studies. PMID:27999528

[The continuous graphic presentation of interdepartmental results (author's transl)].

PubMed

Berger, J; Hirsch, H

1976-10-01

The results of interdepartmental determinations can be clearly presented in the laboratory in two ways: 1. Entry on a test card, according to Shewhart, as used in internal quality control. 2. Entry on a test card, constructed on the principle of the Cusum test. By the latter procedure, systematic errors are detected sooner than with the usual test card. A graphic variant of the Cusum test is described; a V-mask is not required; the card superficially resembles the usual control card, and the calculation time is minimal. This method may also be used to advantage in internal quality control.

[A re-evaluation of the program for diabetes mellitus type 2. A proposal for quality indices].

PubMed

Espinàs, J; Salla, R M; Bellvehí, M; Reig, E; Iruela, T; Muñoz, E; Isern, R; Molas, M

1993-02-28

To find out how accurate our records are and the state of health of the patients with diabetes mellitus type II (DM) in our Base Health Area (BHA) in Osona county (Barcelona), both before and after introducing a new procedure. Quality control study based on the medical records (PCMR) of DM patients. The evaluation took place between 1.1.90 and 31.12.90; and the re-evaluation between 1.1.91 and 31.12.91, after the DM procedure had been put in place as a corrective measure. 198 patients: all of those suffering from DM type II. 110 women and 88 men, with an average age of 65.4 +/- 11.9, were under study. We observed from the records of attendance that 94.4% were or had been smokers, whereas the question of the eye fundus was only mentioned in 36.8%. The introduction of a procedure has improved the records in almost every parameter. In 1991, 36.8% of the patients had normal-weight criteria, 33.3% had good biochemical control and 15.6% fulfilled both these criteria. Those tests which could be performed with few instruments were carried out much better than those which needed more complex technology or specialist support. Arising from this study, the authors propose four indicators of quality control: 1) Weight normality. 2) Annual plasmatic fructosamine. 3) Annual eye fundus check. 4) Annual proteinuria check.

Comparison of Piezosurgery and Conventional Rotary Instruments for Removal of Impacted Mandibular Third Molars: A Randomized Controlled Clinical and Radiographic Trial

PubMed Central

Shokry, Mohamed; Aboelsaad, Nayer

2016-01-01

The purpose of this study was to test the effect of the surgical removal of impacted mandibular third molars using piezosurgery versus the conventional surgical technique on postoperative sequelae and bone healing. Material and Methods. This study was carried out as a randomized controlled clinical trial: split mouth design. Twenty patients with bilateral mandibular third molar mesioangular impaction class II position B indicated for surgical extraction were treated randomly using either the piezosurgery or the conventional bur technique on each site. Duration of the procedure, postoperative edema, trismus, pain, healing, and bone density and quantity were evaluated up to 6 months postoperatively. Results. Test and control sites were compared using paired t-test. There was statistical significance in reduction of pain and swelling in test sites, where the time of the procedure was statistically increased in test site. For bone quantity and quality, statistical difference was found where test site showed better results. Conclusion. Piezosurgery technique improves quality of patient's life in form of decrease of postoperative pain, trismus, and swelling. Furthermore, it enhances bone quality within the extraction socket and bone quantity along the distal aspect of the mandibular second molar. PMID:27597866

Proposed quality control guidelines for antimicrobial susceptibility tests using tilmicosin.

PubMed Central

Shryock, T R; White, D W; Werner, C S; Staples, J M

1995-01-01

Quality control guidelines for tilmicosin, a novel veterinary-use-only macrolide, were developed in a multi-laboratory study according to established National Committee for Clinical Laboratory Standards (NCCLS) procedures (M23-T2). Tilmicosin was incorporated into Sensititre plates for broth microdilution endpoint testing and into two lots of 15-micrograms disks for Kirby-Bauer agar disk diffusion testing. One common lot and five unique lots of Mueller-Hinton media were used. (Broth was cation adjusted, and agar was supplemented with 5% defibrinated sheep blood.) Bacteria used for reference strains included Pasteurella haemolytica 128K, Pasteurella multocida ATCC 43137, and Staphylococcus aureus ATCC 29213 (microdilution) and ATCC 25923 (disk). Replicate tests were conducted. Disk diffusion and broth microdilution quality control ranges are proposed. PMID:7714188

Sap flow sensors: construction, quality control and comparison.

PubMed

Davis, Tyler W; Kuo, Chen-Min; Liang, Xu; Yu, Pao-Shan

2012-01-01

This work provides a design for two types of sensors, based on the thermal dissipation and heat ratio methods of sap flow calculation, for moderate to large scale deployments for the purpose of monitoring tree transpiration. These designs include a procedure for making these sensors, a quality control method for the final products, and a complete list of components with vendors and pricing information. Both sensor designs were field tested alongside a commercial sap flow sensor to assess their performance and show the importance for quality controlling the sensor outputs. Results show that for roughly 2% of the cost of commercial sensors, self-made sap flow sensors can provide acceptable estimates of the sap flow measurements compared to the commercial sensors.

Computer-oriented emissions inventory procedure for urban and industrial sources

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

Runca, E.; Zannetti, P.; Melli, P.

1978-06-01

A knowledge of the rate of emission of atmospheric pollutants is essential for the enforcement of air quality control policies. A computer-oriented emission inventory procedure has been developed and applied to Venice, Italy. By using optically readable forms this procedure avoids many of the errors inherent in the transcription and punching steps typical of approaches applied so far. Moreover, this procedure allows an easy updating of the inventory. Emission patterns of SO/sub 2/ in the area of Venice showed that the total urban emissions were about 6% of those emitted by industrial sources.

Ontological Foundations for Tracking Data Quality through the Internet of Things.

PubMed

Ceusters, Werner; Bona, Jonathan

2016-01-01

Amongst the positive outcomes expected from the Internet of Things for Health are longitudinal patient records that are more complete and less erroneous by complementing manual data entry with automatic data feeds from sensors. Unfortunately, devices are fallible too. Quality control procedures such as inspection, testing and maintenance can prevent devices from producing errors. The additional approach envisioned here is to establish constant data quality monitoring through analytics procedures on patient data that exploit not only the ontological principles ascribed to patients and their bodily features, but also to observation and measurement processes in which devices and patients participate, including the, perhaps erroneous, representations that are generated. Using existing realism-based ontologies, we propose a set of categories that analytics procedures should be able to reason with and highlight the importance of unique identification of not only patients, caregivers and devices, but of everything involved in those measurements. This approach supports the thesis that the majority of what tends to be viewed as 'metadata' are actually data about first-order entities.

Contrast-enhanced MR angiography of the chest and abdomen with use of controlled apnea in children.

PubMed

Saleh, Roya S; Patel, Swati; Lee, Margaret H; Boechat, M Ines; Ratib, Osman; Saraiva, Carla R; Finn, J Paul

2007-06-01

To retrospectively determine if controlled apnea improves the image quality of contrast material--enhanced magnetic resonance (MR) angiography of the chest and abdomen in children. Institutional review board approval and waiver of informed consent were obtained for this HIPAA-compliant study. The authors evaluated contrast-enhanced MR angiographic procedures performed in the chest, abdomen, or both, in 23 children (14 boys, nine girls; age range, 1 month to 8 years) who were under general anesthesia. All patients underwent mechanical ventilation with preoxygenation (100% oxygen) prior to controlled apnea during image acquisition. In control subjects, the authors assessed contrast-enhanced MR angiographic procedures performed in the chest, abdomen, or both, in 23 children (matched for age and type of study with children in the controlled apnea group; 11 boys, 12 girls; age range, 1 month to 8 years) who were under general anesthesia (n=15) or deep sedation (n=8) and were breathing spontaneously during image acquisition. MR angiograms of the chest, abdomen, or both, were assessed for image quality, motion artifacts, and vessel definition by two radiologists working in consensus with a subjective grading scale. Wilcoxon signed rank test was used to assess differences in measurements. Image quality was rated excellent in 97% (30 of 31) of studies with controlled apnea and in 30% (nine of 31) of control studies (P<.001). Motion artifacts were absent in 97% (30 of 31) of studies with controlled apnea and 13% (four of 31) of control studies (P<.001). Vessel sharpness was rated as being significantly better on images obtained with controlled apnea (P<.05). There were no complications caused by anesthesia or sedation in either group. Controlled apnea is highly effective in children for eliminating respiratory motion artifacts with contrast-enhanced MR angiographic studies, resulting in greatly improved image quality and spatial resolution. (c) RSNA, 2007.

Automating PACS quality control with the Vanderbilt image processing enterprise resource

NASA Astrophysics Data System (ADS)

Esparza, Michael L.; Welch, E. Brian; Landman, Bennett A.

2012-02-01

Precise image acquisition is an integral part of modern patient care and medical imaging research. Periodic quality control using standardized protocols and phantoms ensures that scanners are operating according to specifications, yet such procedures do not ensure that individual datasets are free from corruption; for example due to patient motion, transient interference, or physiological variability. If unacceptable artifacts are noticed during scanning, a technologist can repeat a procedure. Yet, substantial delays may be incurred if a problematic scan is not noticed until a radiologist reads the scans or an automated algorithm fails. Given scores of slices in typical three-dimensional scans and widevariety of potential use cases, a technologist cannot practically be expected inspect all images. In large-scale research, automated pipeline systems have had great success in achieving high throughput. However, clinical and institutional workflows are largely based on DICOM and PACS technologies; these systems are not readily compatible with research systems due to security and privacy restrictions. Hence, quantitative quality control has been relegated to individual investigators and too often neglected. Herein, we propose a scalable system, the Vanderbilt Image Processing Enterprise Resource (VIPER) to integrate modular quality control and image analysis routines with a standard PACS configuration. This server unifies image processing routines across an institutional level and provides a simple interface so that investigators can collaborate to deploy new analysis technologies. VIPER integrates with high performance computing environments has successfully analyzed all standard scans from our institutional research center over the course of the last 18 months.

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

Control of Suspect/Counterfeit and Defective Items

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

Sheriff, Marnelle L.

2013-09-03

This procedure implements portions of the requirements of MSC-MP-599, Quality Assurance Program Description. It establishes the Mission Support Alliance (MSA) practices for minimizing the introduction of and identifying, documenting, dispositioning, reporting, controlling, and disposing of suspect/counterfeit and defective items (S/CIs). employees whose work scope relates to Safety Systems (i.e., Safety Class [SC] or Safety Significant [SS] items), non-safety systems and other applications (i.e., General Service [GS]) where engineering has determined that their use could result in a potential safety hazard. MSA implements an effective Quality Assurance (QA) Program providing a comprehensive network of controls and verification providing defense-in-depth by preventingmore » the introduction of S/CIs through the design, procurement, construction, operation, maintenance, and modification of processes. This procedure focuses on those safety systems, and other systems, including critical load paths of lifting equipment, where the introduction of S/CIs would have the greatest potential for creating unsafe conditions.« less

Quality Assurance Project Plan for Closure of the Central Facilities Area Sewage Treatment Plant Lagoon 3 and Land Application Area

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

Lewis, Michael G.

This quality assurance project plan describes the technical requirements and quality assurance activities of the environmental data collection/analyses operations to close Central Facilities Area Sewage treatment Plant Lagoon 3 and the land application area. It describes the organization and persons involved, the data quality objectives, the analytical procedures, and the specific quality control measures to be employed. All quality assurance project plan activities are implemented to determine whether the results of the sampling and monitoring performed are of the right type, quantity, and quality to satisfy the requirements for closing Lagoon 3 and the land application area.

Effects of live music therapy sessions on quality of life indicators, medications administered and hospital length of stay for patients undergoing elective surgical procedures for brain.

PubMed

Walworth, Darcy; Rumana, Christopher S; Nguyen, Judy; Jarred, Jennifer

2008-01-01

The physiological and psychological stress that brain tumor patients undergo during the entire surgical experience can considerably affect several aspects of their hospitalization. The purpose of this study was to examine the effects of live music therapy on quality of life indicators, amount of medications administered and length of stay for persons receiving elective surgical procedures of the brain. Subjects (N = 27) were patients admitted for some type of surgical procedure of the brain. Subjects were randomly assigned to either the control group receiving no music intervention (n = 13) or the experimental group receiving pre and postoperative live music therapy sessions (n = 14). Anxiety, mood, pain, perception of hospitalization or procedure, relaxation, and stress were measured using a self-report Visual Analog Scale (VAS) for each of the variables. The documented administration of postoperative pain medications; the frequency, dosage, type, and how it was given was also compared between groups. Experimental subjects live and interactive music therapy sessions, including a pre-operative session and continuing with daily sessions until the patient was discharged home. Control subjects received routine hospital care without any music therapy intervention. Differences in experimental pretest and posttest scores were analyzed using a Wilcoxon Matched-Pairs Signed-Rank test. Results indicated statistically significant differences for 4 of the 6 quality of life measures: anxiety (p = .03), perception of hospitalization (p = .03), relaxation (p = .001), and stress (p = .001). No statistically significant differences were found for mood (p > .05) or pain (p > .05) levels. Administration amounts of nausea and pain medications were compared with a Two-Way ANOVA with One Repeated Measure resulting in no significant differences between groups and medications, F(1, 51) = 0.03; p > .05. Results indicate no significant differences between groups for length of stay (t = .97, df = 25, p > .05). This research study indicates that live music therapy using patient-preferred music can be beneficial in improving quality of life indicators such as anxiety, perception of the hospitalization or procedure, relaxation, and stress in patients undergoing surgical procedures of the brain.

WIM data analyst's manual

DOT National Transportation Integrated Search

2010-06-01

This manual provides information and recommended procedures to be utilized by an agencys Weigh-in-Motion (WIM) Office Data Analyst to perform validation and quality control (QC) checks of WIM traffic data. This manual focuses on data generated by ...

Analysis of QA procedures at the Oregon Department of Transportation.

DOT National Transportation Integrated Search

2010-06-01

This research explored the Oregon Department of Transportation (ODOT) practice of Independent Assurance (IA), : for validation of the contractors test methods, and Verification, for validation of the contractors Quality Control : (QC) data. The...

A survey of digital radiography practice in four South African teaching hospitals: an illuminative study.

PubMed

Nyathi, T; Chirwa, Tf; van der Merwe, Dg

2010-01-01

The purpose of this study was to assess radiographer familiarity and preferences with digital radiography in four teaching hospitals and thereafter make recommendations in line with the migration from screen film to digital radiography. A questionnaire was designed to collect data from either qualified or student radiographers from four teaching hospitals. From the four teaching hospitals, there were a total of 205 potential respondents. Among other things, responses regarding experiences and preferences with digital radiography, quality control procedures, patient dose, advantages and disadvantages of digital radiography were sought. The information collected was based on self-reporting by the participants. The study is exploratory in nature and descriptive statistics were generated from the collected data using Microsoft Excel 2007 and StatsDirect software. Sixty-three out of 205 (31%) radiographers from all the four radiology centers responded to the circulated questionnaire. Only 15% (8) of the qualified radiographers had 4 or more years of experience with digital radiography compared to 68% (36) for the same amount of experience with screen-film radiography. Sixty-one percent (38) of the participants had been exposed to digital radiography during their lectures while at university. A small proportion, 16% (10) of the respondents underwent formal training in quality control procedures on the digital X-ray units they were using. Slightly more than half (55%) of the participants felt it was easier for them to retake an image in digital radiography than in screen film radiography. The results of this survey showed that the participants are familiar with digital radiography and have embraced this relatively new technology as shown by the fact that they can identify both its advantages and disadvantages as applied to clinical practice. However, there are minimal quality control procedures specific to digital radiography being undertaken as such there is need for formal education, continuing education and manufacturer training with respect to quality control as institutions make the transition from conventional screen film radiology to digital radiology.

The effect of work system on the hand exposure of workers in 18F-FDG production centres.

PubMed

Wrzesień, Małgorzata

2018-05-07

The production of the 18 F isotope-the marker of deoxyglucose ( 18 F-FDG)-the radiopharmaceutical most commonly used in the oncological diagnostic technique of positron emission tomography, requires a cyclotron device. At present, there are nine facilities working in Poland that are equipped with cyclotrons used for producing the short-lived isotopes. The aim of the paper is to determine the hand exposure of workers employed in the two 18 F-FDG production centres taking in to account the production procedures and work system in those facilities. Measurements, which included all professional workers exposed to ionizing radiation that were employed in two facilities, were performed by using high-sensitivity thermoluminescent detectors during the routine activities of the personnel. The work system used at the production centre has an impact on the level of the recorded doses. Among the production procedures performed by the staff, the highest ionizing radiation doses have been received by the staff during the 18 F-FDG quality control. The maximum estimated annual Hp(0.07) for chemists from the quality control department can exceed the annual skin limit dose (500 mSv). The source of lowest doses on the hands are the cyclotron operating procedure and the 18 F-FDG production, provided that these procedures can't be combined with other production procedures.

Tire Production and Pollution Control. Environmental Education Curriculum. Revised.

ERIC Educational Resources Information Center

Topeka Public Schools, KS.

This unit was developed to introduce secondary students to the many facets of a typical, large manufacturing plant - the Topeka Goodyear Tire and Rubber Company - in an effort to increase awareness of sound environmental practices in industry. Its five major foci include the production of tires and quality control procedures; applications of…

40 CFR 75.24 - Out-of-control periods and adjustment for system bias.

Code of Federal Regulations, 2012 CFR

2012-07-01

... subsequent tests: (1) Apply the procedures for missing data substitution to emissions from affected unit(s... monitor or continuous emission monitoring system is out-of-control, any data recorded by the monitor or monitoring system are not quality-assured and shall not be used in calculating monitor data availabilities...

40 CFR 75.24 - Out-of-control periods and adjustment for system bias.

Code of Federal Regulations, 2011 CFR

2011-07-01

... subsequent tests: (1) Apply the procedures for missing data substitution to emissions from affected unit(s... monitor or continuous emission monitoring system is out-of-control, any data recorded by the monitor or monitoring system are not quality-assured and shall not be used in calculating monitor data availabilities...

40 CFR 75.24 - Out-of-control periods and adjustment for system bias.

Code of Federal Regulations, 2014 CFR

2014-07-01

... subsequent tests: (1) Apply the procedures for missing data substitution to emissions from affected unit(s... monitor or continuous emission monitoring system is out-of-control, any data recorded by the monitor or monitoring system are not quality-assured and shall not be used in calculating monitor data availabilities...

40 CFR 75.24 - Out-of-control periods and adjustment for system bias.

Code of Federal Regulations, 2010 CFR

2010-07-01

... subsequent tests: (1) Apply the procedures for missing data substitution to emissions from affected unit(s... monitor or continuous emission monitoring system is out-of-control, any data recorded by the monitor or monitoring system are not quality-assured and shall not be used in calculating monitor data availabilities...

Impact of rain gauge quality control and interpolation on streamflow simulation: an application to the Warwick catchment, Australia

NASA Astrophysics Data System (ADS)

Liu, Shulun; Li, Yuan; Pauwels, Valentijn R. N.; Walker, Jeffrey P.

2017-12-01

Rain gauges are widely used to obtain temporally continuous point rainfall records, which are then interpolated into spatially continuous data to force hydrological models. However, rainfall measurements and interpolation procedure are subject to various uncertainties, which can be reduced by applying quality control and selecting appropriate spatial interpolation approaches. Consequently, the integrated impact of rainfall quality control and interpolation on streamflow simulation has attracted increased attention but not been fully addressed. This study applies a quality control procedure to the hourly rainfall measurements obtained in the Warwick catchment in eastern Australia. The grid-based daily precipitation from the Australian Water Availability Project was used as a reference. The Pearson correlation coefficient between the daily accumulation of gauged rainfall and the reference data was used to eliminate gauges with significant quality issues. The unrealistic outliers were censored based on a comparison between gauged rainfall and the reference. Four interpolation methods, including the inverse distance weighting (IDW), nearest neighbors (NN), linear spline (LN), and ordinary Kriging (OK), were implemented. The four methods were firstly assessed through a cross-validation using the quality-controlled rainfall data. The impacts of the quality control and interpolation on streamflow simulation were then evaluated through a semi-distributed hydrological model. The results showed that the Nash–Sutcliffe model efficiency coefficient (NSE) and Bias of the streamflow simulations were significantly improved after quality control. In the cross-validation, the IDW and OK methods resulted in good interpolation rainfall, while the NN led to the worst result. In term of the impact on hydrological prediction, the IDW led to the most consistent streamflow predictions with the observations, according to the validation at five streamflow-gauged locations. The OK method performed second best according to streamflow predictions at the five gauges in the calibration period (01/01/2007–31/12/2011) and four gauges during the validation period (01/01/2012–30/06/2014). However, NN produced the worst prediction at the outlet of the catchment in the validation period, indicating a low robustness. While the IDW exhibited the best performance in the study catchment in terms of accuracy, robustness and efficiency, more general recommendations on the selection of rainfall interpolation methods need to be further explored.

Impact of rain gauge quality control and interpolation on streamflow simulation: an application to the Warwick catchment, Australia

NASA Astrophysics Data System (ADS)

Liu, Shulun; Li, Yuan; Pauwels, Valentijn R. N.; Walker, Jeffrey P.

2018-01-01

Rain gauges are widely used to obtain temporally continuous point rainfall records, which are then interpolated into spatially continuous data to force hydrological models. However, rainfall measurements and interpolation procedure are subject to various uncertainties, which can be reduced by applying quality control and selecting appropriate spatial interpolation approaches. Consequently, the integrated impact of rainfall quality control and interpolation on streamflow simulation has attracted increased attention but not been fully addressed. This study applies a quality control procedure to the hourly rainfall measurements obtained in the Warwick catchment in eastern Australia. The grid-based daily precipitation from the Australian Water Availability Project was used as a reference. The Pearson correlation coefficient between the daily accumulation of gauged rainfall and the reference data was used to eliminate gauges with significant quality issues. The unrealistic outliers were censored based on a comparison between gauged rainfall and the reference. Four interpolation methods, including the inverse distance weighting (IDW), nearest neighbors (NN), linear spline (LN), and ordinary Kriging (OK), were implemented. The four methods were firstly assessed through a cross-validation using the quality-controlled rainfall data. The impacts of the quality control and interpolation on streamflow simulation were then evaluated through a semi-distributed hydrological model. The results showed that the Nash–Sutcliffe model efficiency coefficient (NSE) and Bias of the streamflow simulations were significantly improved after quality control. In the cross-validation, the IDW and OK methods resulted in good interpolation rainfall, while the NN led to the worst result. In term of the impact on hydrological prediction, the IDW led to the most consistent streamflow predictions with the observations, according to the validation at five streamflow-gauged locations. The OK method performed second best according to streamflow predictions at the five gauges in the calibration period (01/01/2007–31/12/2011) and four gauges during the validation period (01/01/2012–30/06/2014). However, NN produced the worst prediction at the outlet of the catchment in the validation period, indicating a low robustness. While the IDW exhibited the best performance in the study catchment in terms of accuracy, robustness and efficiency, more general recommendations on the selection of rainfall interpolation methods need to be further explored.

Quantitative, functional, morphological and ultrastructural recovery of platelets as predictor for cryopreservation.

PubMed

Balint, Bela; Vucetić, Dusan; Trajković-Lakić, Zlatija; Petakov, Marijana; Bugarski, Diana; Brajusković, Goran; Taseski, Jovan

2002-01-01

Cryopreservation of platelets is of great interest, since it could extend the shelf life of therapeutic platelet concentrates and facilitate stockpiling and inventory control in blood banking. Despite the use of many cryopreservation procedures the optimal cryopreservation procedure is not defined yet. We have compared the cryopreservation of human platelets by various protocols employing controlled-rate and non-controlled-rate freezing procedures in combination with different concentrations of DMSO (6% and 10%) or 5% DMSO + 6% HES combination. After storage for 1 to 3 months, samples were thawed and analyzed. Measurements included cell recovery, platelet viability according to hypotonic shock response (HSR), platelet aggregation with ADP, morphological and ultrastructural properties of defrozen platelets. Our findings show that the application of our original procedure for controlled-rate freezing consisting of six cooling steps (cooling rate 1 degree C/min) with compensation of released heat of fusion (cooling rate 2 degrees C/min) has significantly influenced the quality of thawed platelets. At the same time, a concentration of 6% DMSO proved to be the most effective. In summary, cryopreservation of human platelets using controlled-rate freezing procedure in combination with lower (6%) DMSO concentration resulted in less damage from freezing and higher recovered function of platelets.

Influence of surgical and minimally invasive facial cosmetic procedures on psychosocial outcomes: a systematic review.

PubMed

Imadojemu, Sotonye; Sarwer, David B; Percec, Ivona; Sonnad, Seema S; Goldsack, Jennifer E; Berman, Morgan; Sobanko, Joseph F

2013-11-01

Millions of surgical and minimally invasive cosmetic procedures of the face are performed each year, but objective clinical measures that evaluate surgical procedures, such as complication rates, have limited utility when applied to cosmetic procedures. While there may be subjective improvements in appearance, it is important to determine if these interventions have an impact on patients in other realms such as psychosocial functioning. This is particularly important in light of the Patient Protection and Affordable Care Act and its emphasis on patient-centered outcomes and effectiveness. To review the literature investigating the impact of facial cosmetic surgery and minimally invasive procedures on relevant psychological variables to guide clinical practice and set norms for clinical performance. English-language randomized clinical trials and prospective cohort studies that preoperatively and postoperatively assessed psychological variables in at least 10 patients seeking surgical or minimally invasive cosmetic procedures of the face. Only 1 study investigating minimally invasive procedures was identified. Most studies reported modest improvement in psychosocial functioning, which included quality of life, self-esteem, and body image. Unfortunately, the overall quality of evidence is limited owing to an absence of control groups, short follow-up periods, or loss to follow-up. The current literature suggests that a number of psychosocial domains may improve following facial cosmetic surgery, although the quality of this evidence is limited (grade of recommendation 2A). Despite the dramatic rise in nonsurgical cosmetic procedures, there is a paucity of information regarding the impact of chemodenervation and soft-tissue augmentation on psychosocial functioning.

Large Area Silicon Sheet by EFG. [quality control and productivity of edge-defined film-fed growth of ribbons

NASA Technical Reports Server (NTRS)

1979-01-01

Influences on ribbon quality which might be caused by various materials of construction which are used in the growth furnace were assessed. At the present level of ribbon quality, which has produced 8.5% to 9.5% efficient solar cells, no particular influence of any furnace part was detected. The experiments led to the suspicion that the general environment and the somewhat unoptimized materials handling procedures might be responsible for the current variations in ribbon quality and that, therefore, continuous work with this furnace under rather more stringent environmental conditions and operating procedures could perhaps improve materials quality to some extent. The work on the multiple furnace was continued with two multiple growth runs being performed. In these runs, the melt replenishment system performed poorly and extensive modifications to it were designed to make reliable melt feeding for five ribbon growth possible. Additional characterization techniques for wide ribbons, stress measurements, and growth dynamics experiments are reported.

Hemodynamic outcomes of the Ross procedure versus other aortic valve replacement: a systematic review and meta-analysis.

PubMed

Um, Kevin J; Mcclure, Graham R; Belley-Cote, Emilie P; Gupta, Saurabh; Bouhout, Ismail; Lortie, Hugo; Alraddadi, Hatim; Alsagheir, Ali; Bossard, Matthias; Mcintyre, William F; Lengyel, Alexandra; Eikelboom, John W; Ouzounian, Maral; Chu, Michael W; Parry, Dominic; El-Hamamsy, Ismail; Whitlock, Richard P

2018-06-01

Life expectancy in young adults undergoing mechanical or bioprosthetic aortic valve replacement (AVR) may be reduced by up to 20 years compared to age matched controls. The Ross procedure is a durable, anticoagulation-sparing alternative. We performed a systematic review and meta-analysis to compare the valve hemodynamics of the Ross procedure versus other AVR. We searched Cochrane CENTRAL, MEDLINE and EMBASE from inception to February 2017 for randomized controlled trials (RCTs) and observational studies (n≥10 Ross). Independently and in duplicate, we performed title and abstract screening, full-text eligibility assessment, and data collection. We evaluated the risk of bias with the Cochrane and CLARITY tools, and the quality of evidence with the GRADE framework. We identified 2 RCTs and 13 observational studies that met eligibility criteria (N.=1412). In observational studies, the Ross procedure was associated with a lower mean aortic gradient at discharge (MD -9 mmHg, 95% CI: -13 to -5, P<0.0001, I2=97%) and latest follow-up (MD -5 mmHg, 95% CI: -7 to -3, P<0.0001, I2=92%). There was no significant difference in the incidence of severe aortic regurgitation at latest follow-up (RR 1.3, 95% CI: 0.3 to 5.8, P=0.70, I2=30%). In RCTs, the Ross procedure was associated with a lower mean gradient at latest follow-up (MD -15 mmHg, 95% CI: -32 to 2, P=0.08, I2=99%). The mean pulmonic gradient for the Ross procedure was 18.0 mmHg (95% CI: 16 to 20, P<0.0001) at latest follow-up. The evidence for all outcomes from observational studies was deemed to be of very low quality, while the evidence from RCTs was downgraded for imprecision and moderately serious risk of bias. Compared to conventional AVR, the Ross procedure was associated with better aortic valve hemodynamics. Future studies should evaluate the impact of the Ross procedure on exercise capacity and quality of life.

Performance tests and quality control of cathode ray tube displays.

PubMed

Roehrig, H; Blume, H; Ji, T L; Browne, M

1990-08-01

Spatial resolution, noise, characteristic curve, and absolute luminance are the essential parameters that describe physical image quality of a display. This paper presents simple procedures for assessing the performance of a cathode ray tube (CRT) in terms of these parameters as well as easy set up techniques. The procedures can be used in the environment where the CRT is used. The procedures are based on a digital representation of the Society of Motion Pictures and Television Engineers pattern plus a few simple other digital patterns. Additionally, measurement techniques are discussed for estimating brightness uniformity, veiling glare, and distortion. Apart from the absolute luminance, all performance features can be assessed with an uncalibrated photodetector and the eyes of a human observer. The measurement techniques especially enable the user to perform comparisons of different display systems.

Improving accuracy of unbound resilient modulus testing

DOT National Transportation Integrated Search

1997-07-01

The P46 Laboratory Startup and Quality Control Procedure was developed to ensure the accuracy and reliability of the resilient modulus data produced while testing soil and aggregate materials using closed-loop servo-hydraulic systems. It was develope...

Liquid and gaseous oxygen safety review, volume 1

NASA Technical Reports Server (NTRS)

Lapin, A.

1972-01-01

Materials used or contained in liquid and gaseous oxygen systems are analyzed for their compatibility; and areas of possible concern in oxygen systems are outlined. Design criteria, cleaning procedures, and quality control methods are covered in detail.

14 CFR 1216.201 - Applicability.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION ENVIRONMENTAL QUALITY Floodplain and Wetlands Management § 1216.201 Applicability. These procedures are applicable to Federal lands and facilities under the management control of NASA Headquarters and field installations regardless of location. ...

Research on Objectives for High-School Biology

ERIC Educational Resources Information Center

Korgan, John J., Jr.; Wilson, John T.

1973-01-01

Describes procedures to develop instructional objectives for high school biology. Two kinds of objectives are identified as pre-objectives and performance objectives. Models to classify these in branches of biology and to ensure quality control are provided. (PS)

Pedestrian injury causation parameters. Phase 2

DOT National Transportation Integrated Search

1981-10-01

This report describes data collection, quality control and data analysis procedures for a five-team program to study pedestrian injury causation factors. The data file contains 1,997 pedestrian accidents collected during a two and one-half year perio...

Development of the Global Measles Laboratory Network.

PubMed

Featherstone, David; Brown, David; Sanders, Ray

2003-05-15

The routine reporting of suspected measles cases and laboratory testing of samples from these cases is the backbone of measles surveillance. The Global Measles Laboratory Network (GMLN) has developed standards for laboratory confirmation of measles and provides training resources for staff of network laboratories, reference materials and expertise for the development and quality control of testing procedures, and accurate information for the Measles Mortality Reduction and Regional Elimination Initiative. The GMLN was developed along the lines of the successful Global Polio Laboratory Network, and much of the polio laboratory infrastructure was utilized for measles. The GMLN has developed as countries focus on measles control activities following successful eradication of polio. Currently more than 100 laboratories are part of the global network and follow standardized testing and reporting procedures. A comprehensive laboratory accreditation process will be introduced in 2002 with six quality assurance and performance indicators.

METHOD 544. DETERMINATION OF MICROCYSTINS AND ...

EPA Pesticide Factsheets

Method 544 is an accurate and precise analytical method to determine six microcystins (including MC-LR) and nodularin in drinking water using solid phase extraction and liquid chromatography tandem mass spectrometry (SPE-LC/MS/MS). The advantage of this SPE-LC/MS/MS is its sensitivity and ability to speciate the microcystins. This method development task establishes sample preservation techniques, sample concentration and analytical procedures, aqueous and extract holding time criteria and quality control procedures. Draft Method 544 undergone a multi-laboratory verification to ensure other laboratories can implement the method and achieve the quality control measures specified in the method. It is anticipated that Method 544 may be used in UCMR 4 to collect nationwide occurrence data for selected microcystins in drinking water. The purpose of this research project is to develop an accurate and precise analytical method to concentrate and determine selected MCs and nodularin in drinking water.

The Importance of Experimental Design, Quality Assurance, and Control in Plant Metabolomics Experiments.

PubMed

Martins, Marina C M; Caldana, Camila; Wolf, Lucia Daniela; de Abreu, Luis Guilherme Furlan

2018-01-01

The output of metabolomics relies to a great extent upon the methods and instrumentation to identify, quantify, and access spatial information on as many metabolites as possible. However, the most modern machines and sophisticated tools for data analysis cannot compensate for inappropriate harvesting and/or sample preparation procedures that modify metabolic composition and can lead to erroneous interpretation of results. In addition, plant metabolism has a remarkable degree of complexity, and the number of identified compounds easily surpasses the number of samples in metabolomics analyses, increasing false discovery risk. These aspects pose a large challenge when carrying out plant metabolomics experiments. In this chapter, we address the importance of a proper experimental design taking into consideration preventable complications and unavoidable factors to achieve success in metabolomics analysis. We also focus on quality control and standardized procedures during the metabolomics workflow.

Evaluation of Various Radar Data Quality Control Algorithms Based on Accumulated Radar Rainfall Statistics

NASA Technical Reports Server (NTRS)

Robinson, Michael; Steiner, Matthias; Wolff, David B.; Ferrier, Brad S.; Kessinger, Cathy; Einaudi, Franco (Technical Monitor)

2000-01-01

The primary function of the TRMM Ground Validation (GV) Program is to create GV rainfall products that provide basic validation of satellite-derived precipitation measurements for select primary sites. A fundamental and extremely important step in creating high-quality GV products is radar data quality control. Quality control (QC) processing of TRMM GV radar data is based on some automated procedures, but the current QC algorithm is not fully operational and requires significant human interaction to assure satisfactory results. Moreover, the TRMM GV QC algorithm, even with continuous manual tuning, still can not completely remove all types of spurious echoes. In an attempt to improve the current operational radar data QC procedures of the TRMM GV effort, an intercomparison of several QC algorithms has been conducted. This presentation will demonstrate how various radar data QC algorithms affect accumulated radar rainfall products. In all, six different QC algorithms will be applied to two months of WSR-88D radar data from Melbourne, Florida. Daily, five-day, and monthly accumulated radar rainfall maps will be produced for each quality-controlled data set. The QC algorithms will be evaluated and compared based on their ability to remove spurious echoes without removing significant precipitation. Strengths and weaknesses of each algorithm will be assessed based on, their abilit to mitigate both erroneous additions and reductions in rainfall accumulation from spurious echo contamination and true precipitation removal, respectively. Contamination from individual spurious echo categories will be quantified to further diagnose the abilities of each radar QC algorithm. Finally, a cost-benefit analysis will be conducted to determine if a more automated QC algorithm is a viable alternative to the current, labor-intensive QC algorithm employed by TRMM GV.

Sensitivity of the diagnostic radiological index of protection to procedural factors in fluoroscopy.

PubMed

Jones, A Kyle; Pasciak, Alexander S; Wagner, Louis K

2016-07-01

To evaluate the sensitivity of the diagnostic radiological index of protection (DRIP), used to quantify the protective value of radioprotective garments, to procedural factors in fluoroscopy in an effort to determine an appropriate set of scatter-mimicking primary beams to be used in measuring the DRIP. Monte Carlo simulations were performed to determine the shape of the scattered x-ray spectra incident on the operator in different clinical fluoroscopy scenarios, including interventional radiology and interventional cardiology (IC). Two clinical simulations studied the sensitivity of the scattered spectrum to gantry angle and patient size, while technical factors were varied according to measured automatic dose rate control (ADRC) data. Factorial simulations studied the sensitivity of the scattered spectrum to gantry angle, field of view, patient size, and beam quality for constant technical factors. Average energy (Eavg) was the figure of merit used to condense fluence in each energy bin to a single numerical index. Beam quality had the strongest influence on the scattered spectrum in fluoroscopy. Many procedural factors affect the scattered spectrum indirectly through their effect on primary beam quality through ADRC, e.g., gantry angle and patient size. Lateral C-arm rotation, common in IC, increased the energy of the scattered spectrum, regardless of the direction of rotation. The effect of patient size on scattered radiation depended on ADRC characteristics, patient size, and procedure type. The scattered spectrum striking the operator in fluoroscopy is most strongly influenced by primary beam quality, particularly kV. Use cases for protective garments should be classified by typical procedural primary beam qualities, which are governed by the ADRC according to the impacts of patient size, anatomical location, and gantry angle.

[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.

Multistate Evaluation of an Ultrafiltration-Based Procedure for Simultaneous Recovery of Enteric Microbes in 100-Liter Tap Water Samples▿

PubMed Central

Hill, Vincent R.; Kahler, Amy M.; Jothikumar, Narayanan; Johnson, Trisha B.; Hahn, Donghyun; Cromeans, Theresa L.

2007-01-01

Ultrafiltration (UF) is increasingly being recognized as a potentially effective procedure for concentrating and recovering microbes from large volumes of water and treated wastewater. Because of their very small pore sizes, UF membranes are capable of simultaneously concentrating viruses, bacteria, and parasites based on size exclusion. In this study, a UF-based water sampling procedure was used to simultaneously recover representatives of these three microbial classes seeded into 100-liter samples of tap water collected from eight cities covering six hydrologic areas of the United States. The UF-based procedure included hollow-fiber UF as the primary step for concentrating microbes and then used membrane filtration for bacterial culture assays, immunomagnetic separation for parasite recovery and quantification, and centrifugal UF for secondary concentration of viruses. Water samples were tested for nine water quality parameters to investigate whether water quality data correlated with measured recovery efficiencies and molecular detection levels. Average total method recovery efficiencies were 71, 97, 120, 110, and 91% for φX174 bacteriophage, MS2 bacteriophage, Enterococcus faecalis, Clostridium perfringens spores, and Cryptosporidium parvum oocysts, respectively. Real-time PCR and reverse transcription-PCR (RT-PCR) for seeded microbes and controls indicated that tap water quality could affect the analytical performance of molecular amplification assays, although no specific water quality parameter was found to correlate with reduced PCR or RT-PCR performance. PMID:17483281

Examining the Impact of Covariates on Anchor Tests to Ascertain Quality over Time in a College Admissions Test

ERIC Educational Resources Information Center

Wiberg, Marie; von Davier, Alina A.

2017-01-01

We propose a comprehensive procedure for the implementation of a quality control process of anchor tests for a college admissions test with multiple consecutive administrations. We propose to examine the anchor tests and their items in connection with covariates to investigate if there was any unusual behavior in the anchor test results over time…

Linking Six Sigma to simulation: a new roadmap to improve the quality of patient care.

PubMed

Celano, Giovanni; Costa, Antonio; Fichera, Sergio; Tringali, Giuseppe

2012-01-01

Improving the quality of patient care is a challenge that calls for a multidisciplinary approach, embedding a broad spectrum of knowledge and involving healthcare professionals from diverse backgrounds. The purpose of this paper is to present an innovative approach that implements discrete-event simulation (DES) as a decision-supporting tool in the management of Six Sigma quality improvement projects. A roadmap is designed to assist quality practitioners and health care professionals in the design and successful implementation of simulation models within the define-measure-analyse-design-verify (DMADV) or define-measure-analyse-improve-control (DMAIC) Six Sigma procedures. A case regarding the reorganisation of the flow of emergency patients affected by vertigo symptoms was developed in a large town hospital as a preliminary test of the roadmap. The positive feedback from professionals carrying out the project looks promising and encourages further roadmap testing in other clinical settings. The roadmap is a structured procedure that people involved in quality improvement can implement to manage projects based on the analysis and comparison of alternative scenarios. The role of Six Sigma philosophy in improvement of the quality of healthcare services is recognised both by researchers and by quality practitioners; discrete-event simulation models are commonly used to improve the key performance measures of patient care delivery. The two approaches are seldom referenced and implemented together; however, they could be successfully integrated to carry out quality improvement programs. This paper proposes an innovative approach to bridge the gap and enrich the Six Sigma toolbox of quality improvement procedures with DES.

Correlation of hospital magnet status with the quality of physicians performing neurosurgical procedures in New York State.

PubMed

Bekelis, Kimon; Missios, Symeon; MacKenzie, Todd A

2018-01-24

The quality of physicians practicing in hospitals recognized for nursing excellence by the American Nurses Credentialing Center has not been studied before. We investigated whether Magnet hospital recognition is associated with higher quality of physicians performing neurosurgical procedures. We performed a cohort study of patients undergoing neurosurgical procedures from 2009-2013, who were registered in the New York Statewide Planning and Research Cooperative System (SPARCS) database. Propensity score adjusted multivariable regression models were used to adjust for known confounders, with mixed effects methods to control for clustering at the facility level. An instrumental variable analysis was used to control for unmeasured confounding and simulate the effect of a randomized trial. During the study period, 185,277 patients underwent neurosurgical procedures, and met the inclusion criteria. Of these, 66,607 (35.6%) were hospitalized in Magnet hospitals, and 118,670 (64.4%) in non-Magnet institutions. Instrumental variable analysis demonstrated that undergoing neurosurgical operations in Magnet hospitals was associated with a 13.6% higher chance of being treated by a physician with superior performance in terms of mortality (95% CI, 13.2% to 14.1%), and a 4.3% higher chance of being treated by a physician with superior performance in terms of length-of-stay (LOS) (95% CI, 3.8% to 4.7%) in comparison to non-Magnet institutions. The same associations were present in propensity score adjusted mixed effects models. Using a comprehensive all-payer cohort of neurosurgical patients in New York State we identified an association of Magnet hospital recognition with superior physician performance.

Quality control by HyperSpectral Imaging (HSI) in solid waste recycling: logics, algorithms and procedures

NASA Astrophysics Data System (ADS)

Bonifazi, Giuseppe; Serranti, Silvia

2014-03-01

In secondary raw materials and recycling sectors, the products quality represents, more and more, the key issue to pursuit in order to be competitive in a more and more demanding market, where quality standards and products certification play a preheminent role. These goals assume particular importance when recycling actions are applied. Recovered products, resulting from waste materials, and/or dismissed products processing, are, in fact, always seen with a certain suspect. An adequate response of the industry to the market can only be given through the utilization of equipment and procedures ensuring pure, high-quality production, and efficient work and cost. All these goals can be reached adopting not only more efficient equipment and layouts, but also introducing new processing logics able to realize a full control of the handled material flow streams fulfilling, at the same time, i) an easy management of the procedures, ii) an efficient use of the energy, iii) the definition and set up of reliable and robust procedures, iv) the possibility to implement network connectivity capabilities finalized to a remote monitoring and control of the processes and v) a full data storage, analysis and retrieving. Furthermore the ongoing legislation and regulation require the implementation of recycling infrastructure characterised by high resources efficiency and low environmental impacts, both aspects being strongly linked to the waste materials and/or dismissed products original characteristics. For these reasons an optimal recycling infrastructure design primarily requires a full knowledge of the characteristics of the input waste. What previously outlined requires the introduction of a new important concept to apply in solid waste recycling, the recycling-oriented characterization, that is the set of actions addressed to strategically determine selected attributes, in order to get goaloriented data on waste for the development, implementation or improvement of recycling strategies. The problems arising when suitable HyperSpectral Imaging (HSI) based procedures have to be developed and implemented to solid waste products characterization, in order to define time efficient compression and interpretation techniques, are thus analyzed and discussed in the following. Particular attention was also addressed to define an integrated hardware and software (HW and SW) platform able to perform a non-intrusive, non-contact and real-time analysis and embedding a core of analytical logics and procedures to utilize both at laboratory and industrial scale. Several case studies, referred to waste plastics products, are presented and discussed.

[The hybrid operating room. Home of high-end intraoperative imaging].

PubMed

Gebhard, F; Riepl, C; Richter, P; Liebold, A; Gorki, H; Wirtz, R; König, R; Wilde, F; Schramm, A; Kraus, M

2012-02-01

A hybrid operating room must serve the medical needs of different highly specialized disciplines. It integrates interventional techniques for cardiovascular procedures and allows operations in the field of orthopaedic surgery, neurosurgery and maxillofacial surgery. The integration of all steps such as planning, documentation and the procedure itself saves time and precious resources. The best available imaging devices and user interfaces reduce the need for extensive personnel in the OR and facilitate new minimally invasive procedures. The immediate possibility of postoperative control images in CT-like quality enables the surgeon to react to problems during the same procedure without the need for later revision.

The effect of column purification on cDNA indirect labelling for microarrays

PubMed Central

Molas, M Lia; Kiss, John Z

2007-01-01

Background The success of the microarray reproducibility is dependent upon the performance of standardized procedures. Since the introduction of microarray technology for the analysis of global gene expression, reproducibility of results among different laboratories has been a major problem. Two of the main contributors to this variability are the use of different microarray platforms and different laboratory practices. In this paper, we address the latter question in terms of how variation in one of the steps of a labelling procedure affects the cDNA product prior to microarray hybridization. Results We used a standard procedure to label cDNA for microarray hybridization and employed different types of column chromatography for cDNA purification. After purifying labelled cDNA, we used the Agilent 2100 Bioanalyzer and agarose gel electrophoresis to assess the quality of the labelled cDNA before its hybridization onto a microarray platform. There were major differences in the cDNA profile (i.e. cDNA fragment lengths and abundance) as a result of using four different columns for purification. In addition, different columns have different efficiencies to remove rRNA contamination. This study indicates that the appropriate column to use in this type of protocol has to be experimentally determined. Finally, we present new evidence establishing the importance of testing the method of purification used during an indirect labelling procedure. Our results confirm the importance of assessing the quality of the sample in the labelling procedure prior to hybridization onto a microarray platform. Conclusion Standardization of column purification systems to be used in labelling procedures will improve the reproducibility of microarray results among different laboratories. In addition, implementation of a quality control check point of the labelled samples prior to microarray hybridization will prevent hybridizing a poor quality sample to expensive micorarrays. PMID:17597522

The effect of column purification on cDNA indirect labelling for microarrays.

PubMed

Molas, M Lia; Kiss, John Z

2007-06-27

The success of the microarray reproducibility is dependent upon the performance of standardized procedures. Since the introduction of microarray technology for the analysis of global gene expression, reproducibility of results among different laboratories has been a major problem. Two of the main contributors to this variability are the use of different microarray platforms and different laboratory practices. In this paper, we address the latter question in terms of how variation in one of the steps of a labelling procedure affects the cDNA product prior to microarray hybridization. We used a standard procedure to label cDNA for microarray hybridization and employed different types of column chromatography for cDNA purification. After purifying labelled cDNA, we used the Agilent 2100 Bioanalyzer and agarose gel electrophoresis to assess the quality of the labelled cDNA before its hybridization onto a microarray platform. There were major differences in the cDNA profile (i.e. cDNA fragment lengths and abundance) as a result of using four different columns for purification. In addition, different columns have different efficiencies to remove rRNA contamination. This study indicates that the appropriate column to use in this type of protocol has to be experimentally determined. Finally, we present new evidence establishing the importance of testing the method of purification used during an indirect labelling procedure. Our results confirm the importance of assessing the quality of the sample in the labelling procedure prior to hybridization onto a microarray platform. Standardization of column purification systems to be used in labelling procedures will improve the reproducibility of microarray results among different laboratories. In addition, implementation of a quality control check point of the labelled samples prior to microarray hybridization will prevent hybridizing a poor quality sample to expensive micorarrays.

An Automated Inpatient Split-dose Bowel Preparation System Improves Colonoscopy Quality and Reduces Repeat Procedures.

PubMed

Yadlapati, Rena; Johnston, Elyse R; Gluskin, Adam B; Gregory, Dyanna L; Cyrus, Rachel; Werth, Lindsay; Ciolino, Jody D; Grande, David P; Keswani, Rajesh N

2017-07-19

Inpatient colonoscopy preparations are often inadequate, compromising patient safety and procedure quality, while resulting in greater hospital costs. The aims of this study were to: (1) design and implement an electronic inpatient split-dose bowel preparation order set; (2) assess the intervention's impact upon preparation adequacy, repeated colonoscopies, hospital days, and costs. We conducted a single center prospective pragmatic quasiexperimental study of hospitalized adults undergoing colonoscopy. The experimental intervention was designed using DMAIC (define, measure, analyze, improve, and control) methodology. Prospective data collected over 12 months were compared with data from a historical preintervention cohort. The primary outcome was bowel preparation quality and secondary outcomes included number of repeated procedures, hospital days, and costs. On the basis of a Delphi method and DMAIC process, we created an electronic inpatient bowel preparation order set inclusive of a split-dose bowel preparation algorithm, automated orders for rescue medications, and nursing bowel preparation checks. The analysis data set included 969 patients, 445 (46%) in the postintervention group. The adequacy of bowel preparation significantly increased following intervention (86% vs. 43%; P<0.01) and proportion of repeated procedures decreased (2.0% vs. 4.6%; P=0.03). Mean hospital days from bowel preparation initiation to discharge decreased from 8.0 to 6.9 days (P=0.02). The intervention resulted in an estimated 1-year cost-savings of $46,076 based on a reduction in excess hospital days associated with repeated and delayed procedures. Our interdisciplinary initiative targeting inpatient colonoscopy preparations significantly improved quality and reduced repeat procedures, and hospital days. Other institutions should consider utilizing this framework to improve inpatient colonoscopy value.

The role of field auditing in environmental quality assurance management.

PubMed

Claycomb, D R

2000-01-01

Environmental data quality improvement continues to focus on analytical laboratoryperformance with little, if any, attention given to improving the performance of field consultants responsible for sample collection. Many environmental professionals often assume that the primary opportunity for data error lies within the activities conducted by the laboratory. Experience in the evaluation of environmental data and project-wide quality assurance programs indicates that an often-ignored factor affecting environmental data quality is the manner in which a sample is acquired and handled in the field. If a sample is not properly collected, preserved, stored, and transported in the field, even the best laboratory practices and analytical methods cannot deliver accurate and reliable data (i.e., bad data in equals bad data out). Poor quality environmental data may result in inappropriate decisions regarding site characterization and remedial action. Field auditing is becoming an often-employed technique for examining the performance of the environmental sampling field team and how their performance may affect data quality. The field audits typically focus on: (1) verifying that field consultants adhere to project control documents (e.g., Work Plans and Standard Operating Procedures [SOPs]) during field operations; (2) providing third-party independent assurance that field procedures, quality assurance/ quality control (QA/QC)protocol, and field documentation are sufficient to produce data of satisfactory quality; (3) providing a defense in the event that field procedures are called into question; and (4) identifying ways to reduce sampling costs. Field audits are typically most effective when performed on a surprise basis; that is, the sampling contractor may be aware that a field audit will be conducted during some phase of sampling activities but is not informed of the specific day(s) that the audit will be conducted. The audit also should be conducted early on in the sampling program such that deficiencies noted during the audit can be addressed before the majority of field activities have been completed. A second audit should be performed as a follow-up to confirm that the recommended changes have been implemented. A field auditor is assigned to the project by matching, as closely as possible, the auditor's experience with the type of field activities being conducted. The auditor uses a project-specific field audit checklist developed from key information contained in project control documents. Completion of the extensive audit checklist during the audit focuses the auditor on evaluating each aspect of field activities being performed. Rather than examine field team performance after sampling, a field auditor can do so while the samples are being collected and can apply real-time corrective action as appropriate. As a result of field audits, responsible parties often observe vast improvements in their consultant's field procedures and, consequently, receive more reliable and representative field data at a lower cost. The cost savings and improved data quality that result from properly completed field audits make the field auditing process both cost-effective and functional.

[Quality assurance in interventional cardiology].

PubMed

Gülker, H

2009-10-01

Quality assurance in clinical studies aiming at approval of pharmaceutical products is submitted to strict rules, controls and auditing regulations. Comparative instruments to ensure quality in diagnostic and therapeutic procedures are not available in interventional cardiology, likewise in other fields of cardiovascular medicine. Quality assurance simply consists of "quality registers" with basic data not externally controlled. Based on the experiences of clinical studies and their long history of standardization it is assumed that these data may be severely flawed thus being inappropriate to set standards for diagnostic and therapeutic strategies. The precondition for quality assurance are quality data. In invasive coronary angiography and intervention medical indications, the decision making process interventional versus surgical revascularization, technical performance and after - care are essential aspects affecting quality of diagnostics and therapy. Quality data are externally controlled data. To collect quality data an appropriate infrastructure is a necessary precondition which is not existent. For an appropriate infrastructure investments have to be done both to build up as well as to sustain the necessary preconditions. As long as there are no infrastructure and no investments there will be no "quality data". There exist simply registers of data which are not proved to be a basis for significant assurance and enhancement in quality in interventional coronary cardiology. Georg Thieme Verlag KG Stuttgart, New York.

[Colonoscopy quality control as a requirement of colorectal cancer screening].

PubMed

Quintero, Enrique; Alarcón-Fernández, Onofre; Jover, Rodrigo

2013-11-01

The strategies used in population-based colorectal screening strategies culminate in colonoscopy and consequently the success of these programs largely depends on the quality of this diagnostic test. The main factors to consider when evaluating quality are scientific-technical quality, safety, patient satisfaction, and accessibility. Quality indicators allow variability among hospitals, endoscopy units and endoscopists to be determined and can identify those not achieving recommended standards. In Spain, the working group for colonoscopy quality of the Spanish Society of Gastroenterology and the Spanish Society of Gastrointestinal Endoscopy have recently drawn up a Clinical Practice Guideline that contains the available evidence on the quality of screening colonoscopy, as well as the basic requirements that must be met by endoscopy units and endoscopists carrying out this procedure. The implementation of training programs and screening colonoscopy quality controls are strongly recommended to guarantee the success of population-based colorectal cancer screening. Copyright © 2013 Elsevier España, S.L. and AEEH y AEG. All rights reserved.

Analysis of aircraft longitudinal handling qualities

NASA Technical Reports Server (NTRS)

Hess, R. A.

1981-01-01

The optimal control model (OCM) of the human pilot is applied to the study of aircraft handling qualities. Attention is focused primarily on longitudinal tasks. The modeling technique differs from previous applications of the OCM in that considerable effort is expended in simplifying the pilot/vehicle analysis. After briefly reviewing the OCM, a technique for modeling the pilot controlling higher order systems is introduced. Following this, a simple criterion for determining the susceptibility of an aircraft to pilot induced oscillations (PIO) is formulated. Finally, a model-based metric for pilot rating prediction is discussed. The resulting modeling procedure provides a relatively simple, yet unified approach to the study of a variety of handling qualities problems.

Prediction of aircraft handling qualities using analytical models of the human pilot

NASA Technical Reports Server (NTRS)

Hess, R. A.

1982-01-01

The optimal control model (OCM) of the human pilot is applied to the study of aircraft handling qualities. Attention is focused primarily on longitudinal tasks. The modeling technique differs from previous applications of the OCM in that considerable effort is expended in simplifying the pilot/vehicle analysis. After briefly reviewing the OCM, a technique for modeling the pilot controlling higher order systems is introduced. Following this, a simple criterion for determining the susceptibility of an aircraft to pilot-induced oscillations (PIO) is formulated. Finally, a model-based metric for pilot rating prediction is discussed. The resulting modeling procedure provides a relatively simple, yet unified approach to the study of a variety of handling qualities problems.

Prediction of aircraft handling qualities using analytical models of the human pilot

NASA Technical Reports Server (NTRS)

Hess, R. A.

1982-01-01

The optimal control model (OCM) of the human pilot is applied to the study of aircraft handling qualities. Attention is focused primarily on longitudinal tasks. The modeling technique differs from previous applications of the OCM in that considerable effort is expended in simplifying the pilot/vehicle analysis. After briefly reviewing the OCM, a technique for modeling the pilot controlling higher order systems is introduced. Following this, a simple criterion for determining the susceptibility of an aircraft to pilot induced oscillations is formulated. Finally, a model based metric for pilot rating prediction is discussed. The resulting modeling procedure provides a relatively simple, yet unified approach to the study of a variety of handling qualities problems.

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.

An integrated bioinformatics approach to improve two-color microarray quality-control: impact on biological conclusions.

PubMed

van Haaften, Rachel I M; Luceri, Cristina; van Erk, Arie; Evelo, Chris T A

2009-06-01

Omics technology used for large-scale measurements of gene expression is rapidly evolving. This work pointed out the need of an extensive bioinformatics analyses for array quality assessment before and after gene expression clustering and pathway analysis. A study focused on the effect of red wine polyphenols on rat colon mucosa was used to test the impact of quality control and normalisation steps on the biological conclusions. The integration of data visualization, pathway analysis and clustering revealed an artifact problem that was solved with an adapted normalisation. We propose a possible point to point standard analysis procedure, based on a combination of clustering and data visualization for the analysis of microarray data.

MODIS Atmospheric Data Handler

NASA Technical Reports Server (NTRS)

Anantharaj, Valentine; Fitzpatrick, Patrick

2008-01-01

The Moderate Resolution Imaging Spectroradiometer (MODIS) Atmosphere Data Handler software converts the HDF data to ASCII format, and outputs: (1) atmospheric profiles of temperature and dew point and (2) total precipitable water. Quality-control data are also considered in the export procedure.

14 CFR 23.621 - Casting factors.

Code of Federal Regulations, 2013 CFR

2013-01-01

... either magnetic particle, penetrant or other approved equivalent non-destructive inspection method; or... percent approved non-destructive inspection. When an approved quality control procedure is established and an acceptable statistical analysis supports reduction, non-destructive inspection may be reduced from...

14 CFR 23.621 - Casting factors.

Code of Federal Regulations, 2012 CFR

2012-01-01

... either magnetic particle, penetrant or other approved equivalent non-destructive inspection method; or... percent approved non-destructive inspection. When an approved quality control procedure is established and an acceptable statistical analysis supports reduction, non-destructive inspection may be reduced from...

14 CFR 23.621 - Casting factors.

Code of Federal Regulations, 2014 CFR

2014-01-01

... either magnetic particle, penetrant or other approved equivalent non-destructive inspection method; or... percent approved non-destructive inspection. When an approved quality control procedure is established and an acceptable statistical analysis supports reduction, non-destructive inspection may be reduced from...

14 CFR 23.621 - Casting factors.

Code of Federal Regulations, 2010 CFR

2010-01-01

... either magnetic particle, penetrant or other approved equivalent non-destructive inspection method; or... percent approved non-destructive inspection. When an approved quality control procedure is established and an acceptable statistical analysis supports reduction, non-destructive inspection may be reduced from...

Testing guide for implementing concrete paving quality control procedures.

DOT National Transportation Integrated Search

2008-03-01

Construction of portland cement concrete pavements is a complex process. A small fraction of the concrete pavements constructed in the : United States over the last few decades have either failed prematurely or exhibited moderate to severe distress. ...