Implementation Of Quality Control Procedures Research Articles

First implementation of quality control procedures on selected X-ray machines in South of Benin

Abstract Introduction: The use of X-ray equipment for medical diagnostic radiography procedures has increased due to advances and complexity of radiological procedures. Achieving good image quality while keeping exposure of workers, public and patient exposure to an acceptable level has become a prerequisite for the radiology department in order to comply with best international practices. The aim of this study was to undertake quality control measurement of seven (7) diagnostic radiography equipment in the south of Benin, the first of its kind. Material and methods: Multifunction detector (Piranha) and beam alignment test tool were used to perform quality control tests on seven (7) X-ray units. The method used as well as the interpretation of the results was based on the American Association of Physicists in Medicine (AAPM), United States Food and Drug Administration (FDA), Healing Arts Radiation Protection (HARP), Institute of Physics and Engineering in Medicine (IPEM), International Atomic Energy Agency (IAEA) and Canadian Safety code 35 (S.C 35) recommendations. Results: The quality control results showed that all X-ray equipment investigated were within standard limits for accuracy of exposure time below 10 ms; reproducibility of kVp, exposure time and dose output; specific dose-kVp2 linearity; and specific dose-mAs linearity. Five (5) out of seven (7) diagnostic X-ray machines passed quality control tests such as X-ray beam alignment, exposure time above 10 ms and kVp accuracy. One (1) X-ray machine failed the quality control test of beam filtration at 70 kVp and above. Conclusions: The findings of this study have provided baseline data for other radiology departments to embark on similar QA/QC activities, and also explore options for optimization of patient dose. However, there is a need to extend the study to cover more diagnostic X-ray machines throughout the country. It is anticipated that this would ultimately assist in improving radiation protection and safety during medical diagnostic radiological procedures.

Evidence-based guideline implementation of quality assurance and quality control procedures in the Saudi National Mental Health Survey

BackgroundThe World Mental Health surveys have been known to apply high standards of quality control, but few studies have been published to document this. Furthermore, the effectiveness of quality control has rarely been reported in the Middle East.Case presentationThe focus of this paper was to highlight the implementation of quality control procedures in the Saudi National Mental Health Survey under the World Mental Health Survey Consortium. The paper summarizes the guidelines implemented for the various phases of survey quality control—the quality assurance procedures, the quality control procedures and the quality control appraisal components—as per previously prescribed recommendations in literature.ConclusionsSurvey quality management is a process and not reducible to a single event. Midstream corrections are warranted by detecting problems and intervening appropriately. The Saudi National Mental Health Survey implemented such procedures through continuous quality improvement.

Estimation of the tensile strength of UHPFRC layers based on non-destructive assessment of the fibre content and orientation

In the present study we propose a procedure for estimating the tensile strength of thin ultra-high performance fibre-reinforced cement-based composite (UHPFRC) layers, which eliminates the need of extracting cores or samples from the structure. This procedure relies on a non-destructive testing (NDT) method based on the ferromagnetic properties of the steel fibres for estimating the parameters of the underlying physical model, namely, the fibre content and the fibre orientation factor, and on laboratory tensile tests for estimating the equivalent rigid-plastic fibre-to-matrix bond strength. An experimental program was developed for establishing the relation between the NDT measurements and the orientation parameters determined from image analysis. Following the proposed procedure, the tensile strength of 36 specimens with varying fibre content and fibre orientation distributions is estimated based on the magnetic measurements and compared to experimental results. The good correlation that is found demonstrates the significance of the proposed NDT method in the implementation of quality control procedures of thin UHPFRC elements/layers.

The Brazilian strategy for monitoring persistent organic pollutants in food obtained from animals

The implementation of quality control procedures in analytical laboratories around the world has become essential in order to ensure the quality and safety of food. This article describes the procedure adopted by the Brazilian government in order to achieve this goal, specifically in the area of analysis of organochlorine pesticides (OCPs) and polychlorinated biphenyls (PCBs). The validation of a multiresidue method, the calculation of measurement uncertainty, and the quality control procedure adopted in the determination of these compounds in beef cattle fat were performed as set out in national legislation (Brasil, 2011), which is aligned with international guidelines. Evaluation was made of selectivity, linearity, precision (repeatability and reproducibility), accuracy, and limits of detection and quantification. Stability studies were also undertaken. The technique was extended to three other matrices (poultry, horse, and pig adipose tissues), with evaluation of matrix effects, selectivity, linearity, and accuracy. The analyses were performed by gas chromatography with electron capture detection (GC-ECD) and mass spectrometric detection (GC–MS). In recent years, analyses conducted under the National Plan for Control of Residues and Contaminants (PNCRC) have shown no exceedances of the maximum permitted residue levels (MRLs) of pesticides and PCBs in these tissues, as observed in other countries that carry out effective monitoring of these contaminants.

Use of variance spectra for in‐line validation of process measurements in continuous processes

In‐line oil blending/certification, custody transfer, and performance monitoring are usually carried out with the help of analyzers that measure specific, and typically complex, properties or compositions, which must be reliable and verifiable for economic and regulatory reasons, as well as for safety and quality requirements. In these operations, in‐line measuring devices can generate process data at very high frequencies in typical continuous industrial plants. For this reason, it is proposed here that variance spectra generated by in‐line monitoring devices be used for validation of process measurements and implementation of quality control procedures, while laboratory practices/standards are used to support and evaluate the reliability of the proposed monitoring scheme on a regular basis. The illustrative application studies reveal the great influence that uncertainties and disturbances can exert upon decision‐making in continuous chemical processes and how the proposed monitoring schemes can allow for improvement of process operation and identification of process failures.

Design of a Phase II Control Chart for Monitoring the Ratio of two Normal Variables

In many industrial scenarios, on-line monitoring of quality characteristics computed as the ratio of two normal random variables can be required. Potential industrial applications can include monitoring of processes where the correct proportion of a property between two ingredients or elements within a product should be maintained under statistical control; implementation of quality control procedures where the performance of a product is measured as a ratio before and after some specific operation, for example a chemical reaction following the introduction of an additive in a product and monitoring of a chemical or physical property of a product, which is itself defined and computed as a ratio. This paper considers Phase II Shewhart control charts with each subgroup consisting of n > 1 sample units. From one subgroup to another, the size of each sample unit, upon which a single measurement is made, can be changed. An approximation based on the normal distribution is used to efficiently handle the ratio distribution. Several tables are generated and commented to show the statistical performance of the investigated chart for known and random shift sizes affecting the in-control ratio. An illustrative example from the food industry is given for illustration. Copyright © 2014 John Wiley & Sons, Ltd.

Development of a new generation of high-resolution anatomical models for medical device evaluation: the Virtual Population 3.0

The Virtual Family computational whole-body anatomical human models were originally developed for electromagnetic (EM) exposure evaluations, in particular to study how absorption of radiofrequency radiation from external sources depends on anatomy. However, the models immediately garnered much broader interest and are now applied by over 300 research groups, many from medical applications research fields. In a first step, the Virtual Family was expanded to the Virtual Population to provide considerably broader population coverage with the inclusion of models of both sexes ranging in age from 5 to 84 years old. Although these models have proven to be invaluable for EM dosimetry, it became evident that significantly enhanced models are needed for reliable effectiveness and safety evaluations of diagnostic and therapeutic applications, including medical implants safety. This paper describes the research and development performed to obtain anatomical models that meet the requirements necessary for medical implant safety assessment applications. These include implementation of quality control procedures, re-segmentation at higher resolution, more-consistent tissue assignments, enhanced surface processing and numerous anatomical refinements. Several tools were developed to enhance the functionality of the models, including discretization tools, posing tools to expand the posture space covered, and multiple morphing tools, e.g., to develop pathological models or variations of existing ones. A comprehensive tissue properties database was compiled to complement the library of models. The results are a set of anatomically independent, accurate, and detailed models with smooth, yet feature-rich and topologically conforming surfaces. The models are therefore suited for the creation of unstructured meshes, and the possible applications of the models are extended to a wider range of solvers and physics. The impact of these improvements is shown for the MRI exposure of an adult woman with an orthopedic spinal implant. Future developments include the functionalization of the models for specific physical and physiological modeling tasks.

TH‐A‐18A‐01: Innovation in Clinical Breast Imaging

Several novel modalities have been or are on the verge of being introduced into the breast imaging clinic. These include tomosynthesis imaging, dedicated breast CT, contrast‐enhanced digital mammography, and automated breast ultrasound, all of which are covered in this course.Tomosynthesis and dedicated breast CT address the problem of tissue superimposition that limits mammography screening performance, by improved or full resolution of the 3D breast morphology. Contrast‐enhanced digital mammography provides functional information that allows for visualization of tumor angiogenesis. 3D breast ultrasound has high sensitivity for tumor detection in dense breasts, but the imaging exam was traditionally performed by radiologists. In automated breast ultrasound, the scan is performed in an automated fashion, making for a more practical imaging tool, that is now used as an adjunct to digital mammography in breast cancer screening.This course will provide medical physicists with an in‐depth understanding of the imaging physics of each of these four novel imaging techniques, as well as the rationale and implementation of QC procedures. Further, basic clinical applications and work flow issues will be discussed.Learning Objectives: To be able to describe the underlying physical and physiological principles of each imaging technique, and to understand the corresponding imaging acquisition process. To be able to describe the critical system components and their performance requirements. To understand the rationale and implementation of quality control procedures, as well as regulatory requirements for systems with FDA approval. To learn about clinical applications and understand risks and benefits/strength and weakness of each modality in terms of clinical breast imaging.

EggNOG v4.0: nested orthology inference across 3686 organisms

With the increasing availability of various ‘omics data, high-quality orthology assignment is crucial for evolutionary and functional genomics studies. We here present the fourth version of the eggNOG database (available at http://eggnog.embl.de) that derives nonsupervised orthologous groups (NOGs) from complete genomes, and then applies a comprehensive characterization and analysis pipeline to the resulting gene families. Compared with the previous version, we have more than tripled the underlying species set to cover 3686 organisms, keeping track with genome project completions while prioritizing the inclusion of high-quality genomes to minimize error propagation from incomplete proteome sets. Major technological advances include (i) a robust and scalable procedure for the identification and inclusion of high-quality genomes, (ii) provision of orthologous groups for 107 different taxonomic levels compared with 41 in eggNOGv3, (iii) identification and annotation of particularly closely related orthologous groups, facilitating analysis of related gene families, (iv) improvements of the clustering and functional annotation approach, (v) adoption of a revised tree building procedure based on the multiple alignments generated during the process and (vi) implementation of quality control procedures throughout the entire pipeline. As in previous versions, eggNOGv4 provides multiple sequence alignments and maximum-likelihood trees, as well as broad functional annotation. Users can access the complete database of orthologous groups via a web interface, as well as through bulk download.

Telephone counseling to implement best parenting practices to prevent adolescent problem behaviors

There is considerable suggestive evidence that parents can protect their adolescents from developing problem behaviors if they implement recommended best parenting practices. These include providing appropriate limits on adolescent free time, maintaining a close personal relationship with the adolescent, and negotiating and providing incentives for positive behavior patterns. However, retention of the study samples has limited conclusions that can be drawn from published studies. This randomized controlled trial recruited and randomized a national population sample of 1036 families to an intensive parenting intervention using telephone counseling or to a no-contact control group. At enrollment, eligible families had an eldest child between the ages of 10–13 years. The intervention included an initial training program using a self-help manual with telephone counselor support. Implementation of best parenting practices was encouraged using quarterly telephone contacts and a family management check-up questionnaire. A computer-assisted structured counseling protocol was used to aid parents who needed additional assistance to implement best practices. This, along with a centralized service, enabled implementation of quality control procedures. Assessment of problem behavior is undertaken with repeated telephone interviews of the target adolescents. The study is powered to test whether the intervention encouraging parents to maintain best parenting practices is associated with a reduction of 25% in the incidence of problem behaviors prior to age 18 years and will be tested through a maximum likelihood framework.

A survey of workload, facilities and awareness of uncertainty of measurement among Italian laboratories performing analyses in occupational and environmental medicine

Biological monitoring is essential for risk assessment in the presence of exposure of workers or the general population to harmful chemical agents. Besides the choice of analytical methods which are fit for purpose and the skills of the analysts, the performance of laboratories, including those working in the field of environmental and occupational medicine, also depends on other technical factors such as frequency of testing, the use of well maintained and properly functioning equipment and the implementation of quality control procedures including the participation in External Quality Assessment Schemes (EQAS). Surveys of laboratory workload have been organized periodically since 1997 within the MeTos Project, an Italian national EQAS for biomarkers of environmental and occupational exposure to chemical agents. In 2001, a more extensive survey, including specific technical issues, was organized as part of the activities of the Thematic Network of European Organizers of External Quality Assessment/Proficiency Testing Schemes Related to Occupational and Environmental Medicine (Network survey). In addition, information on the awareness and implementation of the new requirement for laboratories to estimate the uncertainty of their measurements was collected since 2000. The results of these surveys are reported and compared here. In all surveys, Pb in blood was the biomarker most frequently determined. As for biomarkers of exposure to organic compounds, the data collected in the Network survey indicate that methylhippuric acid, hippuric acid and mandelic acid in urine were the assays most commonly performed. About a third of the participants stated that they estimate the uncertainty of at least some of their measurements. Preliminary analysis of data, limited to Pb in blood, showed that analytical performance improved with continuous participation in EQAS and was positively influenced by a high workload.

Seguimiento microbiológico: estrategia para el mejoramiento del registro de la información en los procesos microbiológicos.

The improvement of microbiological information processing in clinical laboratories depends on retention of information concerning who, what, when, how, and why each process was performed, the implementation of quality control procedures, and finally, its evaluation. The four objectives to be addressed are as follows: (1) to improve the collection of information concerned with microbiological processes, (2) to evaluate results of implemented strategies, (3) to offer a model data base to be used in research projects, and (4) to propose an evaluation model for comparative studies. To do this, microbiological cultures were collected from hospitalized patients from June 1997 to June 2003. Data for the analytical matrix were obtained from lab requests, medical history and the microbiological data. Statistical analyses were performed in Epi-Info 6. The laboratory records for 46,072 microbiological cultures were analyzed. Completion levels in data collection were compared between years 1997 and 2003. Samples from 1997 and 2003 showed 11% and 99% of the request forms specifically requesting microbiological culture, 11% and 99% were completed in 1997 and 2003, respectively. For the same years, 9% and 85% specifically stated the time of the request. Ten percent and 68%, respectively, provided complete information. Zero and 83% respectively stated who had collected the sample. Zero and 77%, respectively, specified the time of sample collection. Forms containing all relevent microbiological data were most complete with 78% and 96%, respectively. A database with 44 variables related to microbiological processes was created. In conclusion, improvement of microbiological data processing depends not only on the method of collection and completion of recorded information, but also on constant quality control and evaluation.

Stress measurements in deep boreholes using the Borre (SSPB) probe

Abstract The Borre probe is a unique tool for overcoring stress measurements. It allows three-dimensional stress determination in deep (500 m or more), water-filled boreholes. The probe has been used extensively worldwide for the last 25 years, and has proven to be a reliable tool for measurements in both shallow and deep boreholes. In this paper, the present version of the Borre probe and the measurement procedure is described in detail. The case record of the probe is presented, along with comparisons with results from other stress measurement methods, providing a qualitative verification of the method. Some of the potential error sources are discussed. This includes choice and application of adhesive, gauge misorientation and microcracking. Testing and the implementation of quality control procedures help to minimize the effect of these errors. Examples of typical measurement precision are presented and discussed. A new version of the probe that allows more efficient measurements through wireline pilot hole drilling, as well as improved strain data recording during overcoring is also described.

Data Management And Quality Assurance

Clinical data management is a vital vehicle in clinical trials to ensure the integrity and quality of data being transferred from trial subjects to a database system. Poor management of data is a pitfall to statisticians, study investigators, sponsors, and most importantly, patients. Efforts in quality assurance in clinical data management have been increasing, as reflected in the increase of related publications in MEDLINE during the past 10 years. Despite the success of harmonization of Good Clinical Practice (GCP) in Europe, Japan, and the United States, no harmonized guideline on good clinical data management is available yet. We attempt to examine the current regulatory requirements on clinical data management and to discuss specific issues in data acquisition and data validation consistent with good clinical data management. In summary, good clinical data management currently means compliance with International Conference on Harmonization (ICH) GCP and Food and Drug Administration (FDA) guidelines. The three most important concepts for good clinical data management are implementation of quality control procedures, an audit trail, and quality quantification of the final database. They should all be dictated in standard operating procedures that are continually updated to the current best practice.

A novel comprehensive quality control instrument for medical accelerators

A comprehensive quality control instrument for calibration of medical accelerators that use photon, electron, or proton beams in teleradiotherapy is described. It employs a fluorescence screen, mounted on a central stage with four degrees of freedom, monitored by a CCD camera. A single set-up of the instrument enables one to perform mechanical, light laser, and radiation tests, at arbitrary angles of the accelerator gantry. The new device provides for quantitative evaluation of the tests performed and provides for documentation of the test results in real time. The device provides significant time savings with concurrent improvement in accuracy for tests performed during installation and acceptance processes, and the implementation of quality control procedures for medical accelerators.