01 QUALITY MANAGEMENT Flashcards
A planned and systematic set of quality activities focused on providing confidence that quality requirements will be fulfilled
Quality Assurance
Uses quality indicators which is an established measure used to determine how well an organization meets needs and operational and performance expectaitions
Quality assurance
Verifying the acceptability of methods prior to reporting patient results
Method validation
The ability of a test to detect a given disease or condition
Diagnostic sensitivity
The ability of a test to correctly identify the absence of a given disease or condition
Diagnostic specificity
Formula for diagnostic sensitivity
(TP)/(TP+FN)
Formula for diagnostic specificity
(TN)/(TN+FP)
Chance of an individual having a given condition if the test is abnormal
Positive predictive value
Chance of an individual does not have a given disease or condition if the test is within the reference interval
Negative predictive value
Formula for positive predictive value
(TP)/(TP+FP)
Formula for negative predictive value
(TN)/(TN+FN)
A quality laboratory process that involves statistical analysis of internal control procedures through use of control materials for method performance assessment and nonstatistical check procedures such as linearity studies and reagent checks
Quality control
Examining control materials of known substances along with patient samples to monitor accuracy and precision of the complete examination process
Quality control
The value with the highest frequency, always on the top of every distribution curve
Mode
The value which divides the variable’s observation in two equal parts and represents the center of the distribution
Median
The value which all observations should have if they were equal
Mean
Squared standard deviation that measures variability
Variance
A percentile expression of the mean and an index of precision
Coefficient of variation
Graphical representation of observed values of a control material over time in the context of the upper and lower control limits
Levey-Jennings chart
The limit of a Levey-Jennings chart at +/- 1s limit
68%
The limit of a Levey-Jennings chart at +/- 2s limit
95.5%
The limit of a Levey-Jennings chart at +/- 3s limit
99.7%
Gradual loss of reliability in the test system
Trend