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50 Cards in this Set
- Front
- Back
A system of ensuring accuracy and precision in the laboratory by including quality control reagents in every series of measuremen |
Quality Control |
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This is a systematic laboratory program, encompassing preanalytical, analytical, and postanalytical factors, that monitors excessive variation in specimen |
Quality Assessment |
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TEAT IN QUALITY CONTROL |
● Sensitivity ● Specificity ● Accuracy ● Precision or Reproducibility ● Practicability ● Reliability ● Diagnostic sensitivity ● Diagnostic specificity ● Preanalytical Error ● Analytical Error ● Postanalytical Error ● Linearity Check ● Delta Check ● Standard ● Control ● Westguard Multirules |
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Is the ability of an analytical method to measure the smallest concentration of the analyte of interest. |
Sensitivity |
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It is the ability if an analytical method to measure only the analyte of interest |
Specifity |
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It is the nearness or closeness of the assayed value to the true or target value. |
Accuracy |
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The ability of an analytical method to give repeated results on the same sample that agree with one anothe |
Precision |
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The degree by which a method is easily repeated. |
Practicability |
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The ability of an analytical method to maintain accuracy and precision over an extended period of time during which equipment, reagents, and personnel may change. |
Reliability |
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True Positive Is the ability of the test to detect the proportion of an individual with that decrease who test positive with the test |
Diagnostic Sensitivity |
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True Negative Is the ability of the test to detect the proportion of individuals without the disease who test negatively for the disease. |
Diagnostic Specifity |
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Occurs during sample collection and transport before sample analysis and can include sample preparation and storage conditions. |
Pre Analytical Error |
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Occurs during the testing process and includes problems related to reagents, instruments, controls, calibration, performance of personnel, etc. |
Analytical Error |
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Occurs after the test is performed and refers to the clerical errors, reporting of result, test interpretation, etc. |
Post Analytical Error |
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Determines the lowest and highest values that can be accurately measured by a particular method. |
Linearity Check |
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Assesses the patient’s most recent for a particular test as compared to the patient’s previous value; the difference between the test results (delta) is calculated and compared to establish limits. |
Delta Check |
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Material of known concentration that is used to calibrate an instrument or develop a standard curve. |
Standard |
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Material of known value that is analyzed with patient samples to determine acceptability of results. |
Control |
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Are statistical “rules” applied to graphical summaries of numerical quality control data to assess the acceptability of such data. |
Westgard Rules |
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Involves the analyses of control samples together with that patient specimen. |
Intralab QC |
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Involves proficiency testing program that periodically provides samples of unknown |
Interlab QC |
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OBJECTIVES OF QUALITY CONTROL |
1. To check the stability of the machine. 2. To check the quality of reagents. 3. To check technical errors. |
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It is present in all measurements It is due to chance and can be both positive and negative |
Random Error |
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Is an error that influences observations consistently in one direction (constant difference) |
Systematic Error |
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Refers to the difference between the target value and the assay value. |
Constant Error |
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Results in greater deviation from the target value due to higher sample concentration. |
Percent Error |
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The highest frequency that occurs with the use of handwritten labels and request forms. |
Clerical Error |
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Is the science of gathering, analyzing,interpreting and presenting data |
Statistical Analysis |
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A measure of central tendency. |
Mean |
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The value of observation that divides the observation into two groups, |
Median |
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Is the most frequent observation |
Mode |
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A measure of dispersion of values from the xrew |
Standard Deviation |
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It is called the standard deviation squared |
Variance |
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A percentile expression of the mean, an index of PRECISION |
Coefficient of Variation |
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Used to compare the means or standard deviations of two groups of data |
Inferential Statistics |
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Used to determine whether there is a statistically significant difference between the means of two groups |
F Test |
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Warning rule that initiates testing of control data by |
12s |
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Two control observations consecutively exceeding the same +2s or –2s |
22s |
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One control exceeding the +2s and another exceeding the –2s |
R4s |
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QUALITY CONTROL CHART |
1. Gaussian Curve (Bell Shaped Curve) 2. Cumulative Sum Graph (CUSUM) 3. Youden/Twin Plot 4. Shewhart Levey - Jennings chart |
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It occurs when the date can be accurately described by the SD and the mean. |
Gaussian Curve Bell |
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It calculates the difference between the QC results and the target means |
Cumulative Sum Graph |
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It is used to compares results obtained on a high and low control serum from different laboratories |
Youden |
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Most widely used system in clinical laboratory Allows the laboratorians to apply multiple rules without the aid of computer |
Shewhart Levey Jennings Chart |
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Formed by control values that either increase or decrease for six consecutive days |
Trend |
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It is formed by the control values that distribute themselves on one side or either side of the mean for six consecutive days |
Shift |
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These are control values that are far from the main set of values |
Outliers |
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Main Cause of Trend |
Deterioration of reagents |
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Main Cause of Shift |
Improper Calibration of Instruments |
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Main Cause of Outliers |
Random or Systematic Errors |