Quality Assurance

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Quality Management

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overall process in ensuring the reliability

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Quality Assurance

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Define and improve the quality related process and procedures to ensure quality

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Quality Control

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Evaluate the quality; estimate if it meets the customer's expectations. Known sample

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Testing

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Find defects in the product. This is an unknown sample.

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Total Quality Management

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focuses on themes ptocesses stats and delivery of services that exceeds customer expectation

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CQI

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elements of TQM; developed by Motorolla

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Six Sigma

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a structured process that is based on statistics and quantitative measurements

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Lean

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ultimately designed to reduce waste or non-valued activities; developed by Toyota

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Quality Control

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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

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A process of ensuring analytical results are correct by testing control solutions that resemble patient samples.

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Accuracy

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Indication of how close the result obtained lies to the true value

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Precision

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refers to the reproducibility of the method. How close the values to one another

measured by SD, COE, Variance

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Bias

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The difference between the expectation of a test result and an accepted reference method

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Reliability

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accurate and precise after changes

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Sensitivity

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ability of method to detect the smallesr concentration of substance interest/analyte of interest

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Diagnostic Sensitivity

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ability of analytical method to detect the proportion of individuals with the disease

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Specificity

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ability to measure the substance of interest only in the sample.

e.g., drug screening test, gold standard

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Reference range

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also called normal range; for healthy individuals

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Internal "Intralaboratory QC"

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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"

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Proficiency testing programs periodically provide samples of unknown concentration of analytes to participating laboratories

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Blank

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sets the spectrophotometer at zero absorbance

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Reagent Blank

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Eliminates absorabance imparted by the color of the reagent

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Sample blank

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eliiminates absorbance due to HIL

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Standard

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material known composition used to compute concentration of particular analyte in the patient's sample

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Control material

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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

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control value +/-2SD range and is most used for infrequently run test; expensive and for external checks for accuracy

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Unassayed

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target values and for frequently performed analysis

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Lyophilized

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type of unassayed that is powder; needs diluent to be prepared

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Frozen

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meet the desired temp ; evaluated for stability

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Random error

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Errors that occur by chance

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Systematic error

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errors that consustently affect results in one direction

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Constant

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Refers to a difference between the target value and assay value

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Proportional/Slope/ Percent error

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Leads to greater deviation from the target value due to the higher sampleconcentration

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Clerical error

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Use of handwritten labels; request forms

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Gaussian distribution

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Referred to normal distribution

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Levey-Jennings plot

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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

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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

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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

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gradual lost of reliability in the system. Detoriation of reagent

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Shift

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main cause is improper instrument calibration

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Outliers

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control values that are far from the main set of values. may be caused by random or systematic error

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Range

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Difference between the highest and lowest data points

Represents the extreme of data

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Measures of spread

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Most frequently used measure of variation

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Variance

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Average of the squared distance of all values from the mean