Laboratory Quality Control
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Laboratory Quality Control
Laboratory quality control is designed to detect, reduce, and correct deficiencies in a laboratory's internal analytical process prior to the release of patient results, in order to improve the quality of the results reported by the laboratory. Quality control (QC) is a measure of precision, or how well the measurement system reproduces the same result over time and under varying operating conditions. Laboratory quality control material is usually run at the beginning of each shift, after an instrument is serviced, when reagent lots are changed, after equipment calibration, and whenever patient results seem inappropriate. Quality control material should approximate the same matrix as patient specimens, taking into account properties such as viscosity, turbidity, composition, and color. It should be simple to use, with minimal vial-to-vial variability, because variability could be misinterpreted as systematic error in the method or instrument. It should be stable for long periods of ...
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Precision (statistics)
In statistics, the precision matrix or concentration matrix is the matrix inverse of the covariance matrix or dispersion matrix, P = \Sigma^. For univariate distributions, the precision matrix degenerates into a scalar precision, defined as the reciprocal of the variance, p = \frac. Other summary statistics of statistical dispersion also called ''precision'' (or ''imprecision'') include the reciprocal of the standard deviation, p = \frac; the standard deviation itself and the relative standard deviation; as well as the standard error and the confidence interval (or its half-width, the margin of error). Usage One particular use of the precision matrix is in the context of Bayesian analysis of the multivariate normal distribution: for example, Bernardo & Smith prefer to parameterise the multivariate normal distribution in terms of the precision matrix, rather than the covariance matrix, because of certain simplifications that then arise. For instance, if both the prior and the ...
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Quality Assessment
Quality assurance (QA) is the term used in both manufacturing and service industries to describe the systematic efforts taken to ensure that the product(s) delivered to customer(s) meet with the contractual and other agreed upon performance, design, reliability, and maintainability expectations of that customer. The core purpose of Quality Assurance is to prevent mistakes and defects in the development and production of both manufactured products, such as automobiles and shoes, and delivered services, such as automotive repair and athletic shoe design. Assuring quality and therefore avoiding problems and delays when delivering products or services to customers is what ISO 9000 defines as that "part of quality management focused on providing confidence that quality requirements will be fulfilled". This defect prevention aspect of quality assurance differs from the defect detection aspect of quality control and has been referred to as a ''shift left'' since it focuses on quality effor ...
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Quality Assurance
Quality assurance (QA) is the term used in both manufacturing and service industries to describe the systematic efforts taken to ensure that the product(s) delivered to customer(s) meet with the contractual and other agreed upon performance, design, reliability, and maintainability expectations of that customer. The core purpose of Quality Assurance is to prevent mistakes and defects in the development and production of both manufactured products, such as automobiles and shoes, and delivered services, such as automotive repair and athletic shoe design. Assuring quality and therefore avoiding problems and delays when delivering products or services to customers is what ISO 9000 defines as that "part of quality management focused on providing confidence that quality requirements will be fulfilled". This defect prevention aspect of quality assurance differs from the defect detection aspect of quality control and has been referred to as a ''shift left'' since it focuses on quality effor ...
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Quality Control
Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "a part of quality management focused on fulfilling quality requirements". This approach places emphasis on three aspects (enshrined in standards such as ISO 9001): # Elements such as controls, job management, defined and well managed processes, performance and integrity criteria, and identification of records # Competence, such as knowledge, skills, experience, and qualifications # Soft elements, such as personnel, integrity, confidence, organizational culture, motivation, team spirit, and quality relationships. Inspection is a major component of quality control, where physical product is examined visually (or the end results of a service are analyzed). Product inspectors will be provided with lists and descriptions of unacceptable product defects such as cracks or surface blemishes for example. History and introduction Ea ...
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Population (statistics)
In statistics, a population is a set of similar items or events which is of interest for some question or experiment. A statistical population can be a group of existing objects (e.g. the set of all stars within the Milky Way galaxy) or a hypothetical and potentially infinite group of objects conceived as a generalization from experience (e.g. the set of all possible hands in a game of poker). A common aim of statistical analysis is to produce information about some chosen population. In statistical inference, a subset of the population (a statistical '' sample'') is chosen to represent the population in a statistical analysis. Moreover, the statistical sample must be unbiased and accurately model the population (every unit of the population has an equal chance of selection). The ratio of the size of this statistical sample to the size of the population is called a ''sampling fraction''. It is then possible to estimate the '' population parameters'' using the appropriate ...
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Shewhart Individuals Control Chart
In statistical quality control, the individual/moving-range chart is a type of control chart used to monitor variables data from a business or industrial process for which it is impractical to use rational subgroups. The chart is necessary in the following situations: #Where automation allows inspection of each unit, so rational subgrouping has less benefit. #Where production is slow so that waiting for enough samples to make a rational subgroup unacceptably delays monitoring #For processes that produce homogeneous batches (e.g., chemical) where repeat measurements vary primarily because of measurement error The "chart" actually consists of a pair of charts: one, the individuals chart, displays the individual measured values; the other, the moving range chart, displays the difference from one point to the next. As with other control charts, these two charts enable the user to monitor a process for shifts in the process that alter the mean or variance of the measured statistic. ...
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Hematology Analyzer
Hematology analyzers ( also spelled haematology analysers in British English) are used to count and identify blood cells at high speed with accuracy. During the 1950s, laboratory technicians counted each individual blood cell underneath a microscope. Tedious and inconsistent, this was replaced with the first, very basic hematology analyzer, engineered by Wallace H. Coulter. The early hematology analyzers relied on Coulter's Principle (see Coulter counter). However, they have evolved to encompass numerous techniques. Uses Hematology analyzers are used to conduct a complete blood count (CBC), which is usually the first test requested by physicians to determine a patients general health status. A complete blood count includes red blood cell (RBC), white blood cell (WBC), hemoglobin, and platelet counts, as well as hematocrit levels. Other analyses include: * RBC distribution width * Mean corpuscular volume * Mean corpuscular hemoglobin * Mean corpuscular hemoglobin concentrations ...
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Automated Analyser
An automated analyser is a medical laboratory instrument designed to measure different chemicals and other characteristics in a number of biological samples quickly, with minimal human assistance. These measured properties of blood and other fluids may be useful in the diagnosis of disease. Photometry is the most common method for testing the amount of a specific analyte in a sample. In this technique, the sample undergoes a reaction to produce a color change. Then, a photometer measures the absorbance of the sample to indirectly measure the concentration of analyte present in the sample. The use of an Ion Selective Electrode (ISE) is another common analytical method that specifically measures ion concentrations. This typically measures the concentrations of sodium, calcium or potassium present in the sample. There are various methods of introducing samples into the analyser. Test tubes of samples are often loaded into racks. These racks can be inserted directly into some analy ...
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Systematic Errors
Observational error (or measurement error) is the difference between a measured value of a quantity and its true value.Dodge, Y. (2003) ''The Oxford Dictionary of Statistical Terms'', OUP. In statistics, an error is not necessarily a " mistake". Variability is an inherent part of the results of measurements and of the measurement process. Measurement errors can be divided into two components: ''random'' and ''systematic''. Random errors are errors in measurement that lead to measurable values being inconsistent when repeated measurements of a constant attribute or quantity are taken. Systematic errors are errors that are not determined by chance but are introduced by repeatable processes inherent to the system. Systematic error may also refer to an error with a non-zero mean, the effect of which is not reduced when observations are averaged. Measurement errors can be summarized in terms of accuracy and precision. Measurement error should not be confused with measurement uncer ...
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Westgard Rules
The Westgard rules are a set of statistical patterns, each being unlikely to occur by random variability, thereby raising a suspicion of faulty accuracy or precision of the measurement system. They are used for laboratory quality control, in "runs" consisting of measurements of multiple samples. They are a set of modified Western Electric rules, developed by James Westgard and provided in his books and seminars on quality control. They are plotted on Levey–Jennings charts, wherein the X-axis shows each individual sample, and the Y-axis shows how much each one differs from the mean in terms of standard deviation (SD). The rules are: Review date: 1 April 2020 The recommended consequences when any of the above patterns occur is to reject the run, except for the rule of 12s (top in table), which serves as a warning and a recommendation of careful inspection of the data. See also * Western Electric rules *Nelson rules Nelson rules are a method in process control of determining ...
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Pathologist
Pathology is the study of the causal, causes and effects of disease or injury. The word ''pathology'' also refers to the study of disease in general, incorporating a wide range of biology research fields and medical practices. However, when used in the context of modern medical treatment, the term is often used in a narrower fashion to refer to processes and tests that fall within the contemporary medical field of "general pathology", an area which includes a number of distinct but inter-related medical specialties that diagnose disease, mostly through analysis of tissue (biology), tissue, human cell, cell, and body fluid samples. Idiomatically, "a pathology" may also refer to the predicted or actual progression of particular diseases (as in the statement "the many different forms of cancer have diverse pathologies", in which case a more proper choice of word would be "Pathophysiology, pathophysiologies"), and the affix ''pathy'' is sometimes used to indicate a state of disease ...
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