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44 Cards in this Set
- Front
- Back
Quality Management |
overall process in ensuring the reliability |
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Quality Assurance |
Define and improve the quality related process and procedures to ensure quality |
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Quality Control |
Evaluate the quality; estimate if it meets the customer's expectations. Known sample |
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Testing |
Find defects in the product. This is an unknown sample. |
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Total Quality Management |
focuses on themes ptocesses stats and delivery of services that exceeds customer expectation |
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CQI |
elements of TQM; developed by Motorolla |
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Six Sigma |
a structured process that is based on statistics and quantitative measurements |
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Lean |
ultimately designed to reduce waste or non-valued activities; developed by Toyota |
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Quality Control |
system of ensuring accuracy and precision in the laboratory by including quality control reagents in every series of measurements |
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Quality control |
A process of ensuring analytical results are correct by testing control solutions that resemble patient samples. |
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Accuracy |
Indication of how close the result obtained lies to the true value |
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Precision |
refers to the reproducibility of the method. How close the values to one another measured by SD, COE, Variance |
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Bias |
The difference between the expectation of a test result and an accepted reference method |
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Reliability |
accurate and precise after changes |
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Sensitivity |
ability of method to detect the smallesr concentration of substance interest/analyte of interest |
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Diagnostic Sensitivity |
ability of analytical method to detect the proportion of individuals with the disease |
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Specificity |
ability to measure the substance of interest only in the sample. e.g., drug screening test, gold standard |
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Reference range |
also called normal range; for healthy individuals |
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Internal "Intralaboratory QC" |
Detects both random and systematic errors; Analysis of control samples & patient specimen Perform in a daily basis/daily monitoring |
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External "Interlaboratory QC" |
Proficiency testing programs periodically provide samples of unknown concentration of analytes to participating laboratories |
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Blank |
sets the spectrophotometer at zero absorbance |
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Reagent Blank |
Eliminates absorabance imparted by the color of the reagent |
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Sample blank |
eliiminates absorbance due to HIL |
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Standard |
material known composition used to compute concentration of particular analyte in the patient's sample |
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Control material |
A specimen of known concentration with physical and chemical properties closely resembling the test serum and should be treated like one; used to check accuracy and precision of an analytical method |
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Assayed |
control value +/-2SD range and is most used for infrequently run test; expensive and for external checks for accuracy |
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Unassayed |
target values and for frequently performed analysis |
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Lyophilized |
type of unassayed that is powder; needs diluent to be prepared |
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Frozen |
meet the desired temp ; evaluated for stability |
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Random error |
Errors that occur by chance |
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Systematic error |
errors that consustently affect results in one direction |
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Constant |
Refers to a difference between the target value and assay value |
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Proportional/Slope/ Percent error |
Leads to greater deviation from the target value due to the higher sampleconcentration |
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Clerical error |
Use of handwritten labels; request forms |
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Gaussian distribution |
Referred to normal distribution |
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Levey-Jennings plot |
most commonly used qc chart; Graphical representation of the acceptable limits of variation in the results of analytical method |
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Youden/Twin plot |
Used to compare results attainable on a high and low control serum by different laboratories. Used for Interlab QC programs Desirable for Lab to have its point fall at the center of the plot. |
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Cumulative Sum Graph |
Calculates the difference between QC results and target means Gives the earliest indication of systematic errors and can beused in a 13s rule Very sensitive to small persistent error |
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Trend |
gradual lost of reliability in the system. Detoriation of reagent |
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Shift |
main cause is improper instrument calibration |
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Outliers |
control values that are far from the main set of values. may be caused by random or systematic error |
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Range |
Difference between the highest and lowest data points Represents the extreme of data |
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Measures of spread |
Most frequently used measure of variation |
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Variance |
Average of the squared distance of all values from the mean |