scholarly journals Constancy tests and quality assurance of the activimeters used in a Radiopharmaceutical Production Unit

2019 ◽  
Vol 7 (2A) ◽  
Author(s):  
Rodrigo Modesto Gadelha Gontijo ◽  
Andréa Vidal Ferreira ◽  
Leonardo Tafas Constantino Nascimento ◽  
Flávia Mesquita Costa ◽  
Juliana Batista Silva ◽  
...  
Keyword(s):  
Quality Control ◽  
Quality Assurance ◽  
Entire Range ◽  
Quality Assurance Program ◽  
Dose Administration ◽  
Accuracy And Precision ◽  
Background Check ◽  
Linearity Test ◽  
Brazilian Standard ◽  
Equipment Performance

Activimeters (or dose calibrators) are essential instruments to verify activity of radiopharmaceutical after production and also before the dose administration in humans or animals for molecular imaging. The efficiency and safety measurements depend on, beside other factors, constancy tests and quality assurance. Thereby, the aim of this work was to perform constancy tests and quality assurance in the activimeters of the UPPR/CDTN, based on the CNEN-NN 3.05 Brazilian standard and the manufacturer's manual. Physical inspection, auto zero, background check, camera voltage, data check and constancy test were done. In addition, accuracy and precision tests were performed using a set of standard certified radioactive sources (57Co, 133Ba and 137Cs), according to the CNEN NN 3.05 Brazilian standard. Linearity test was also performed to evaluate the response of the equipment in over the entire range of activities used in routine. The equipments are periodically submitted to the quality control tests and the results were compared. After performing the proposed tests it is possible to conclude that activimeters are in accordance with the requirements of the CNEN standard and manufacturer´s manual. A quality control checklist was prepared to guide users and to record the results of quality assurance testing to monitor the equipment performance. This initiative is part of the quality assurance program implemented at UPPR.

Quality Control

1993 ◽  
Keyword(s):  
Quality Control ◽  
Quality Assurance ◽  
Recombinant Dna ◽  
Expert Witness ◽  
False Negative ◽  
Quality Assurance Program ◽  
Methodology Development ◽  
Accuracy And Precision ◽  
Chain Of Custody ◽  
Dna Restriction

Quality control (QC) is one aspect of quality assurance (QA). Quality assurance also includes (1) periodic laboratory audits by external specialists, (2) keeping upto-date clearly-written protocols, (3) preparation of QA reports, (4) troubleshooting, (5) equipment maintenance and calibration, (6) methodology development, (7) personnel training, (8) continuing education, and (9) laboratory safety. To be assured of ongoing quality performance, laboratory accreditation is mandatory. The above aspects have been discussed throughout this text; however, because DMA profiling often involves legal considerations, details of QC are presented in this chapter. An extremely important report, Guidelines for a Quality Assurance Program for DNA Restriction Fragment Length Polymorphism Analysis, prepared by the Quality Assurance Subcommittee of TWGDAM, is included in Appendix I (Mudd 1989). Quality control, narrowly defined, is directly concerned with the accuracy and precision of laboratory results for specimens of verified origin. Implicit in this definition is assurance that correct and accurate population allele frequencies are used in probability calculations. The expert witness representing the laboratory must ensure that (1) the correct specimen is analyzed, (2) the DNA is not significantly degraded, (3) the specimens are not significantly contaminated with extraneous DNA, (4) the analysis procedure is well-controlled, (5) result interpretation is correct, and (6) no deviations from the authorized laboratory protocol have occurred. The expert witness in DNA profiling should be a meticulous analyst with a solid grasp of genetic and biochemical principles combined with considerable experience in recombinant DNA processes. A reasonable understanding of the concepts and application of statistical techniques, especially probability, is a definite asset. The ability to articulate the results of an analysis and to respond under cross examination to in-depth questions concerning principles, techniques, and chain of custody is mandatory. (See Wetli 1989 for a general overview on appearing as an expert witness.) A set of objective QC criteria must be established and followed to ensure that neither false negative nor false positive DNA profile match results are released from a service laboratory.

scholarly journals Comparison of ergovaline determinations between laboratories in the United States and Japan

2007 ◽  
Vol 13 ◽  
pp. 283-288
Author(s):  
Morrie Craig ◽  
G. Rottinghaus ◽  
K. Walker ◽  
E. Ishikuro
Keyword(s):  
United States ◽  
Quality Control ◽  
Quality Assurance ◽  
Perennial Ryegrass ◽  
Tall Fescue ◽  
Festuca Arundinacea ◽  
The United States ◽  
Quality Assurance Program ◽  
University Of Missouri ◽  
Keywords Quality Assurance

Quality assurance and quality control is the foundation of any diagnostic test. The two laboratories in the United States that use HPLC to quantitate endophyte toxins in tall fescue (Festuca arundinacea) and perennial ryegrass (Lolium perenne) are Oregon State University (OSU) and University of Missouri (MU). Japan, the major importer of grass straw has six new laboratories that will test agricultural imports for endophyte toxins. A quality assurance program was set up between the Japanese Ministry of Agriculture and the State of Oregon. The latter includes both OSU and the MU. All units are using an accurate crystalline standard and have exchanged "check" samples among themselves. To date OSU and MU have values that differ by 10%. OSU has identified a contaminating and coeluting peak as the cause of the differences. Both laboratories are changing to a Gemini column to rectify the differences. Japanese laboratories are in the process of evaluating their split check samples. Keywords: quality assurance, quality control, endophyte, tall fescue, perennial ryegrass

Statistical Quality Control and Quality Assurance Evaluation of Structural and Paving Concrete

2003 ◽  
Vol 1861 (1) ◽  
pp. 71-85 ◽  
Author(s):  
Ravinder M. Diwan ◽  
Shashikant Shah ◽  
John Eggers
Keyword(s):  
Quality Control ◽  
Quality Assurance ◽  
Control Charts ◽  
Reporting System ◽  
Good Control ◽  
Statistical Quality Control ◽  
Quality Assurance Program ◽  
Major Contributor ◽  
Department Of Transportation ◽  
Structural Concrete

The variability associated with the production, construction, and testing of structural and paving concrete is discussed. Data from more than 900 projects constructed from 1992 through 1999 representing more than 25,000 lots were evaluated. The data were collected from the Louisiana Department of Transportation and Development’s (DOTD’s) computerized Material Test Data Reporting System. The analysis indicated that ( a) overall price reductions were less than 0.2% for structural concrete and about 0.5% for paving concrete, ( b) the thickness of concrete cores is the major contributor to the overall reduction in the price of paving concrete, ( c) there was good control in the production and testing of structural concrete, and ( d) there was an increase in the nonuniformity of paving concrete acceptance criteria. Recommendations include a need to maintain better control of the variability of paving concrete through the application of control charts or unknown variability in the specification types and a need for continued evaluation for monitoring the overall quality control and quality assurance program of the DOTD.

scholarly journals Pengujian Akurasi kVp dan Linearitas pada Pesawat Sinar-X di Laboratorium Prodi Diploma III Teknik Radiodiagnostik dan Radioterapi Purwokerto

2016 ◽  
Vol 2 (2) ◽  
pp. 172-174
Author(s):  
Asri Indah Aryani ◽  
Indra Kartika Nugroho ◽  
Panji Wibowo Nurcahyo
Keyword(s):  
Quality Control ◽  
Test Performance ◽  
Quantitative Research ◽  
Quality Assurance Program ◽  
Control Panel ◽  
International Unit ◽  
Allowable Limit ◽  
X Ray ◽  
Two Stages ◽  
Linearity Test

Background: Quality control is part of the quality assurance program related to the techniques used in the monitoring the maintenance of the technical elements of the system that affect picture quality. KVp accuracy and linearity (test mAs) is one of the components which are tested on the routine test performance evaluations. The X-ray Biomedical International unit brands BRG 100 RF of Laboratory Diploma in Mechanical Radiodiagnostic and Radiotherapy Purwokerto have not been tested yet. The objectives of this study are to determine suitability output kVp accuracy and linearity that have been beeing setting at control panel X-ray unit.Methods: This research belongs to a quantitative research which was conducted in April 2016 at the Laboratory of Radiodiagnostic Diploma Engineering and Radiotherapy Purwokerto on X-ray Biomedical International unit brands BRG 100 RF. The tests carried out two stages of testing. They were the accuracy of kVp with MPD (Multi-purpose detector) tool at kVp 50, 60, 70, 80, 9 and testing linearity method using Stepwedge and Reciprocity mAs Densitometer at 55 kVp, 10 mAs with a variation of 200 mA and 100. The results was analysed based on the quality control examining contained in KMK RI No.1250, the value of deviation accuracy of kVp 6% and for linearity deviation value (mAs) ≤ ± 0.1.Result: The test results showed that there are some deviations occur repeatedly on the accuracy of kVp on the value of eksposi 50, 60, 70, 80, 90, are 0.78%, 1.31%, 1.32%, 1.63%, 2.5%, but the deviation is still within the allowable limits that does not exceed 10%. The linearity testing showes that there are differences in optical density values on the radiograph with variations mA and s which are still within the allowable limit that is ≤ ± 0.1.Conclusion: Based on the result of kVp accuracy and linearity test, the deviation value is still within the tolerance limit or still in accordance with the permissible tolerance according to KMK RI   1250 about quality control testing parameter

Codes, Standards and Regulatory Topics for Nuclear Facilities

2008 ◽  
Author(s):  
Taunia Wilde ◽  
Shannan Baker ◽  
Gary M. Sandquist
Keyword(s):  
Quality Control ◽  
Quality Assurance ◽  
Nuclear Power ◽  
Power Plants ◽  
Nuclear Regulatory Commission ◽  
Department Of Energy ◽  
Quality Assurance Program ◽  
Nuclear Facilities ◽  
The Us ◽  
Regulatory Commission

The design, construction, operation, maintenance, and decommissioning and decontamination of nuclear infrastructure particularly nuclear power plants licensed in the US by the US Nuclear Regulatory Commission (NRC) or operated by the US Department of Energy (DOE) or the US Department of Defense (DOD) must be executed under a rigorous and documented quality assurance program that provides adequate quality control and oversight. Those codes, standards, and orders regulate, document and prescribe the essentials for quality assurance (QA) and quality control (QC) that frequently impact nuclear facilities operated in the US are reviewed and compared.

Quality control of lipid measurements in epidemiological studies: the U.S. Air Force HEART program.

1985 ◽  
Vol 31 (2) ◽  
pp. 261-263 ◽  
Author(s):  
A Hainline ◽  
P Hill ◽  
L Garbaczewski ◽  
C Winn
Keyword(s):  
Quality Control ◽  
Quality Assurance ◽  
Air Force ◽  
Reference Materials ◽  
Internal Control ◽  
Density Lipoprotein ◽  
Quality Assurance Program ◽  
Internal Quality ◽  
Surveillance Program ◽  
The U.S

Abstract A special standardization and quality assurance program, similar to that created for the Lipid Research Clinics Program (LRC), was developed for the American Health Foundation Laboratory by the Centers for Disease Control (CDC) to assure the quality of lipid measurements in the U.S. Air Force Health Evaluation and Risk Tabulation (HEART) Program. This study was designed to test the feasibility of reducing the incidence of heart disease in active-duty U.S. Air Force personnel through life-study intervention. During the 18-month study, CDC provided serum calibrators and reference materials for internal control and an external surveillance program for measurements of total cholesterol (TC) and high-density-lipoprotein cholesterol (HDLC). The Laboratory, using an automated enzymic method to measure cholesterol, achieved an overall goal for accuracy of less than 2% error (av systematic error, -30.6 mg/L) for TC, as measured on nine reference pools for which values were assigned by CDC. The average bias of measurements of HDLC with heparin-manganese to separate the lipoproteins in five CDC reference pools was -4.6 mg/L. Bias was estimated relative to the values assigned to the reference materials by the CDC reference methods for TC and HDLC. The average CV for TC was 0.89%, for HDLC 2.66%. Accuracy of cholesterol measurements can be assured over time with a standardization and quality-assurance program that incorporates accurately labeled reference materials for calibration, internal quality control, and external surveillance.

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