p2cc Flashcards
A pre-analytical error can be introduced by:
A. Drawing a coagulation tube before an EDTA tube
B. Mixing an EDTA tube 8 to 10 times
C. Transporting the specimen in a biohazard bag
D. Vigorously shaking the blood tube to prevent clotting
D. Vigorously shaking the blood tube to prevent clotting
Feedback
Vigorously mixing can cause hemolysis
In quality control, ± 2 standard deviations from the mean includes what percentage of the sample population?
A. 50%
B. 75%
C. 95%
D. 98%
D. 95%
Feedback
The probability of an observation having a value within ± 2 standard deviations of the mean in a normal distribution is 95%.
The acceptable limit of error in the chemistry laboratory is 2 standard deviations. If you run the normal control of 100 times, how many of the values would be out of the control range due to random error?
A. 1
B. 5
C. 10
D. 20
B. 5
Feedback
The probability of an observation having a value of 2 SD from the mean in a normal distribution is 95.5%. Therefore, 5 control values out of 100 would be out of control due to random error.
The following data were calculated on a series of 30 determinations of serum uric acid control: mean = 5.8 mg/dL, 1 standard deviation = 0.15 mg/dL. If confidence limits are set at ± 2 SD, which o f the following represents allowable limits for the control?
A. 5.65 to 5.95 mg/dL
B. 5.35 to 6.25 mg/dL
C. 5.50 to 6.10 mg/dL
D. 5.70 to 5.90 mg/dL
C. 5.50 to 6.10 mg/dL
Feedback
Standard deviation is a measure of the dispersion of data around the mean.
A delta check is a method that:
A. Determines the mean and variance of an instrument
B. Monitors the testing system for precision
C. Monitors patient sample day by day
D. Is determined by each laboratory facility
C. Monitors patient sample day by day
Feedback
The delta check method compares current results from automated analyzers with the result from the most recent, previous values for the same patient
Measures of Center
Choose 3
A. Coefficient of variation
B. Mean
C. Median
D. Mode
E. Range
F. Standard deviation
B,C,D
Feedback
The three most commonly used descriptions of the center of a dataset are the mean, the median, and the mode.
Measures of spread
Choose 3
A. Coefficient of variation
B. Mean
C. Median
D. Mode
E. Range
F. Standard deviation
A,E,F
Feedback
The spread represents the relationship of all the data points to the mean. There are three commonly used descriptions of spread: (1) range (2) standard deviation (SD), and (3) coefficient of variation (CV).
Systematic errors
Choose 3
A. Calibrator reconstitution
B. Electro-optical mechanism
C. Environmental conditions
D. Fluctuations in line voltage
E. Instability of instrument
F. Reagent dispensing
G. Reagent lot variability
H. Sample evaporation
I. Temperature of analyzer
J. Variation in handling techniques: pipetting, mixing, timing
K. Variation in operators
L. Wear and tear of instrument
D,G,L
Feedback
Reference: Clinical Chemistry: A Laboratory Perspective [Arneson]
A SYSTEMATIC ERROR, on the other hand, will be seen as a trend in the data. Control values gradually rise (or fall) from the previously established limits. This type of error includes improper calibration, deterioration of reagents, sample instability, instrument drift, or changes in standard materials. All the Westgard rules that indicate trends identify systematic errors. 2(2S), 4(1S) and 10(x) rule.
SYSTEMATIC ERRORS MAY BE DUE TO:
Aging reagents
Aging calibrators
Instrument components
Optical changes
Fluctuations in line voltage
Wear and tear of instrument
Reagent lot variability
Calibration differences
Technologist interactions
Random Errors
Choose 3
A. Aging reagents
B. Aging calibrators
C. Calibration differences
D. Instrument components
E. Fluctuations in line voltage
F. Optical changes
G. Reagent lot variability
H. Reagent dispensing
I. Technologist interactions
J. Variation in handling techniques: pipetting, mixing, timing
K. Variation in operator
L. Wear and tear of instrument
H,J,K
Feedback
Reference: Clinical Chemistry: A Laboratory Perspective [Arneson]
RANDOM ERROR is one with no trend or means of predicting it. Random errors include such situations as mislabeling a sample, pipetting errors, improper mixing of sample and reagent, voltage fluctuations not compensated for by instrument circuitry, and temperature fluctuations. Violations of the 1(2S), 1(3S) and R(4S) Westgard rules are usually associated with random error. To assess the situation, the sample is assayed using the same reagents. If a random error occurred, the same mistake may not be made again, and the result will be within appropriate control limits.
RANDOM ERRORS MAY BE DUE TO:
Reagent dispensing
Sample evaporation
Temperature of analyzer
Electro-optical mechanism
Calibrator reconstitution
Environmental conditions
Instability of instrument
Variation in handling techniques: pipetting, mixing, timing
Variation in operators
Most frequently occurring value in a dataset:
A. Mean
B. Median
C. Mode
D. Range
C. Mode
Feedback
The mode is the most frequently occurring value in a dataset. Although it is seldom used to describe data, it is referred to when in reference to the shape of data, a bimodal distribution, for example.
Type of systemic error in the sample direction and magnitude; the magnitude of change is constant and not dependent on the amount of analyte.
A. Constant systematic error
B. Proportional systematic error
A. Constant systematic error
Feedback
Constant error: Type of systemic error in the sample direction and magnitude; the magnitude of change is constant and not dependent on the amount of analyte.
Proportional error: Type of systemic error where the magnitude changes as a percent of the analyte present; error dependent on analyte concentration.
Type of systemic error where the magnitude changes as a percent of the analyte present; error dependent on analyte concentration.
A. Constant systematic error
B. Proportional systematic error
B. Proportional systematic error
Feedback
Constant error: Type of systemic error in the sample direction and magnitude; the magnitude of change is constant and not dependent on the amount of analyte.
Proportional error: Type of systemic error where the magnitude changes as a percent of the analyte present; error dependent on analyte concentration.
Difference between the observed mean and the reference mean:
A. Bias
B. Confidence interval
C. Parametric method
D. Nonparametric method
A. Bias
Feedback
Bias: Difference between the observed mean and the reference mean.
Negative bias indicates that the test values tend to be lower than the reference value, whereas positive bias indicates test values are generally higher.
Bias is a type of constant systematic error.
Ability of a test to detect a given disease or condition.
A. Analytic sensitivity
B. Analytic specificity
C. Diagnostic sensitivity
D. Diagnostic specificity
C. Diagnostic sensitivity
Feedback
Analytic sensitivity: Ability of a method to detect small quantities of an analyte.
Analytic specificity: Ability of a method to detect only the analyte it is designed to determine.
Diagnostic sensitivity: Ability of a test to detect a given disease or condition.
Diagnostic specificity: Ability of a test to correctly identify the absence of a given disease or condition.
Ability of a test to correctly identify the absence of a given disease or condition.
A. Analytic sensitivity
B. Analytic specificity
C. Diagnostic sensitivity
D. Diagnostic specificity
D. Diagnostic specificity
Feedback
Analytic sensitivity: Ability of a method to detect small quantities of an analyte.
Analytic specificity: Ability of a method to detect only the analyte it is designed to determine.
Diagnostic sensitivity: Ability of a test to detect a given disease or condition.
Diagnostic specificity: Ability of a test to correctly identify the absence of a given disease or condition.
Ability of a method to detect small quantities of an analyte.
A. Analytic sensitivity
B. Analytic specificity
C. Diagnostic sensitivity
D. Diagnostic specificity
A. Analytic sensitivity
Feedback
Analytic sensitivity: Ability of a method to detect small quantities of an analyte.
Analytic specificity: Ability of a method to detect only the analyte it is designed to determine.
Diagnostic sensitivity: Ability of a test to detect a given disease or condition.
Diagnostic specificity: Ability of a test to correctly identify the absence of a given disease or condition.
Ability of a method to detect only the analyte it is designed to determine.
A. Analytic sensitivity
B. Analytic specificity
C. Diagnostic sensitivity
D. Diagnostic specificity
B. Analytic specificity
Feedback
Analytic sensitivity: Ability of a method to detect small quantities of an analyte.
Analytic specificity: Ability of a method to detect only the analyte it is designed to determine.
Diagnostic sensitivity: Ability of a test to detect a given disease or condition.
Diagnostic specificity: Ability of a test to correctly identify the absence of a given disease or condition.
Positive predictive value:
A. Ability of a test to detect a given disease or condition.
B. Ability of a test to correctly identify the absence of a given disease or condition.
C. Chance of an individual having a given disease or condition if the test is abnormal.
D. Chance an individual does not have a given disease or condition if the test is within the reference interval.
C. Chance of an individual having a given disease or condition if the test is abnormal.
Feedback
Positive predictive value: Chance of an individual having a given disease or condition if the test is abnormal.
Negative predictive value: Chance an individual does not have a given disease or condition if the test is within the reference interval.
Negative predictive value:
A. Ability of a test to detect a given disease or condition.
B. Ability of a test to correctly identify the absence of a given disease or condition.
C. Chance of an individual having a given disease or condition if the test is abnormal.
D. Chance an individual does not have a given disease or condition if the test is within the reference interval.
D. Chance an individual does not have a given disease or condition if the test is within the reference interval.
What percentage of values will fall between ±2 s in a Gaussian (normal) distribution?
A. 34.13%
B. 68.26%
C. 95.45%
D. 99.74%
C. 95.45%
Feedback
68.26% will lie within ±1 s
95.45% will lie within ±2 s
99.74% will lie within ±3 s
Two (2) consecutive control values exceed the same 2 standard deviation limit:
A. 1:2S
B. 2:2S
C. R:4S
D. 4:1S
B. 2:2S
Feedback
Westgard multirule is a control procedure that utilizes control rules to assess numerical quality control data; the control rules establish the limits for data rejection in a system with two controls. Other rules apply when three controls are used.
1:2s = 1 control value exceeds the mean ±2 standard deviations; warning rule that triggers inspection of control values using the other rejection rules that follow; only rule that is not used to reject a run; results are reportable
1:3s = 1 control value exceeds the mean ±3 standard deviations; detects random error
2:2s = 2 consecutive control values exceed the same 2 standard deviation limit (same mean +2 s or same mean -2 s); detects systematic error
R:4s = 1 control value in a group exceeds the mean +2 s and a second control value exceeds the mean -2 s, creating a 4 standard deviation spread; detects random error
4:ls = 4 consecutive control values are recorded on one side of the mean and exceed either the same mean +1 s or the same mean -1 s; detects systematic error
10:x =10 consecutive control values are recorded on one side of the mean (either above or below the mean); detects systematic error