Module 4- Quality Control Flashcards
True/False: majority of medical decisions are made using laboratory data
True
_____ involves the systematic monitoring of analytic processes in order to detect analytic errors that occur during analysis
Quality control
Prevents reporting of incorrect patient test results
Quality control
True/False: expected values are represented by intervals of accepted values with upper and lower limits
True
True/False: Expected values falls within control limits = correct values
True
True/False: when values fall outside control limits, further analysis is done to avoid erroneous reporting of patient results
True
Specimens analyzed for quality control purposes
QC materials
Gold standard for clin. laboratory proficiency testing
CAP Program
A pair of medical decision points that span the limits of results expected for a given condition
Reference interval
How many study individuals are required in verifying a reference interval (transference)?
As few as 20 study individuals
Reference interval applied to therapeutic drug
Therapeutic range
_____ Indicates that test values tend to be lower than the reference value
Negative bias
Ability of a test to detect a given disease or condition
Diagnostic sensitivity
Ability of a test to correctly identify the absence of a given disease or condition
Diagnostic specificity
______ Indicates test values are generally higher
Positive bias
Chance of an individual having a given disease or condition if the test is abnormal
Positive predictive value
Ability of a method to detect small quantities of an analyte
Analytic sensitivity
Chance of an individual does not have a given disease or condition if the test is within tje reference interval
Negative predictive value
Ability of a method to detect only the analyte it is designed to determine
Analytic specificity
Ability of a method to measure only the analyte of interest
Specificity
Error always in one direction
Systemic/systematic error
Approach focusing on process improvement as a means to meet a set standard
Quality management
Used for monitoring teat performance and quality control
Descriptive statistics
Average
Mean
Middle of data
Median
Most frequently occurring
Mode
Represent the relationship of all the data points to the mean
Spread
Dispersion of values around the mean
Coefficient variation
Attempt to apply conclusions that have been obtained from one experimental study to more general population
Inferential statistics
Analyses if the means of two data sets are greatly different from each other
T-test
______ is performed when it is not known whether the two populations have the same variance
F-test
May be caused by variations in techniques
Random error
May be due to several factors, including poorly made standards, reagents, instrumentation problems, etc.,
Systematic error
Pioneered by shewhart in 1920s
Levey Jennings
One control observation exceeding the mean ±2s
1 2s
One control observation exceeding the mean ±3s
1 3s
Two control observation consecutively exceeding the same +2s or -2s
2 2s
One control exceeding the +2s and another exceeding -2s
R 4s
Four consecutive control observations exceeding +1s or -1s.
4 1s
Ten consecutive control observations falling on one side or the other side of the mean
10x
True/False: all proficiency failures and significanys shifts and trends musy be reviewed, investigated, and resolved with 30 days of final receipt of proficiency results.
True
True/False: acceptability criteria for proficiency testing are not provided by the proficiency program
False
True/False: proficiency testing program must demonstrate a dynamic and real-time review time of all proficiency test results by the laboratory director and delegated management personnel
True
Most frequently used measure of variation
Standard deviation
