Stage Biochimie Flashcards
Why should internal QC be performed?
a. To be sure that the QC material meets specifications
b. To examine if the control material is commutable (behaves like patient samples)
c. To have a high probability that correct patient results are released
d. To be able to pass the accreditation inspection
e. To examine if my measurement procedure gives results
similar to other laboratories
C
How should I interpret results when an EQA(External Quality assessement)/PT program uses noncommutable materials?
a. When my result is within the performance specifications, I can be confident that I have no bias compared with a true value.
b. When my result is different than the all method mean, I have to recalibrate my measurement procedure.
c. When my result is close to the target value for the peers in my measurement procedure group, I can be confident my laboratory is performing as well as my peers.
d. I should compare my results with results from other measurement procedures to be confident my laboratory is not biased.
e. I should compare my results with the average of all measurement procedure groups.
C
What is the advantage of using commutable QC materials?
a. They are similar to patient samples and should therefore not be used for QC.
b. They are suitable for internal QC but not for EQA and proficiency testing.
c. They should be avoided because they are contagious.
d. Their results provide information on the accuracy for patient samples if the target value is set by an RMP.
e. Their target values are always assigned by RMPs.
D
How can a reagent lot change affect a QC target value?
a. QC target values are not affected by reagent lot changes.
b. The QC target should be used to verify acceptability of a new reagent lot.
c. The non-commutability bias can be different, so the QC target value may need to be adjusted.
d. The non-commutability bias may be different, so the SD may need to be adjusted.
e. The reagent lot should be rejected if the QC target value is not recovered.
C
How is the SD estimated for an internal QC material?
a. From measurements made during the target value assignment of a QC material
b. From the long-term SD that includes most types of variability expected to influence the measurement procedure
c. From the instructions for use provided by the measurement procedure manufacturer
d. From reports of interlaboratory summaries
e. From the range of acceptable results provided by the QC material manufacturer
B
How frequently should QC samples be measured?
a. Based on the stability of a measurement procedure and the risk of harm from a potentially erroneous result being reported
b. Based on the stability of a measurement procedure
c. Based on the magnitude of the SD used for evaluating QC results
d. Every 24 hours
e. Whenever a result is suspicious
A
How should a target value be established for a QC sample?
a. As the mean of the first 25 results
b. As the mean of the first 10 results
c. As the mean from interlaboratory comparison data
d. As the mean of at least 10 results and updated when more results are available
e. As the standard error of the mean of 10 results
D
What is the first thing to do when a QC result fails an evaluation rule?
a. Repeat the QC sample
b. Recalibrate then repeat the QC sample
c. Check if the previous QC result was acceptable or not
d. Check if the result from a different QC sample measured at the same time was acceptable or not
e. Stop reporting results for patient samples
E
What are the key attributes of a rule used to interpret QC results?
a. The rule should identify a QC result that has a 95% probability of being incorrect.
b. The rule should identify a bias that exceeds the manufacturer’s specification for the measurement procedure.
c. The rule should identify either a bias or an imprecision that exceeds the manufacturer’s specification for the measurement procedure.
d. The rule should identify an error condition that is large enough to increase the risk of an erroneous medical decision based on results for the test.
e. The rule should identify when a measurement procedure is at risk to produce an erroneous result.
D
- The moving average of patient sample results is useful in which of the following situations?
a. When there are a large number of results generated in a short time interval
b. When a physiologically homogeneous population of patients can be identified
c. When the cost of QC samples is very expensive
d. When the measurement procedure is very stable after long time intervals
e. When results can vary within a patient over relatively short time intervals.
B
Which of the following usually best describes the variation in the concentration or activity of most measurands in laboratory medicine?
a. Circadian rhythms
b. Monthly cycles
c. Systematic trends
d. Random variation
e. Seasonal fluctuations
D
Which of the following describes the most appropriate way to find numerical data on the components of biological variation?
a. Determine these in your own laboratory
b. Use a search engine on the Internet
c. Use databases on specific websites
d. Ask a colleague
e. E-mail a query to an internet forum
C
Analytical performance specifications (Select all that apply):
a. Can be calculated using measurement uncertainty.
b. Can be estimated based on biological variation data.
c. Should never be estimated using state of the art of the measurement method.
d. Is not important for setting quality control rules.
e. A measurand can have different analytical performance specifications based on its intended use.
B, E
Which of the following is irrelevant to the creation of reference change values?
a. Within-subject biological variation
b. Examination bias
c. Examination imprecision
d. Pre-examination sources of variation
e. Between-subject biological variation
E
Which of the following represents the individuality of most measurands in laboratory medicine?
a. The index of individuality is high.
b. The index of individuality is low.
c. The measurand has low individuality.
d. The within-subject variation is larger than the betweensubject variation.
e. The analytical imprecision is lower than the withinsubject variation.
B
What are the consequences for the use of the reference change value (RCV) if the applied within-subject variation estimates are derived from a heterogeneously distributed data set?
a. No consequences.
b. The within-subject biological variation will be too high.
c. The RCV can only be used on specific individuals.
d. The RCV is not applicable for use in the general population.
e. The RCV indicates only analytical variation.
D
If the difference between two consecutive examination results in a patient is larger than the reference change value (RCV), what does this mean?
a. That there is a medical change in the condition of the patient
b. There is an error in the analytical system
c. That the difference is larger than what can be explained by analytical and biological variation
d. That the patient has a 95% probability of being seriously ill
e. That the patient belongs to another population
C
What are the consequences of not excluding outliers within samples of each individual when using this data to estimate biological variation?
a. The reference change value cannot be generalized.
b. You have to log transform the data.
c. The within-subject biological variation will be underestimated.
d. The within-subject biological variation will be overestimated.
e. You cannot use the data for meta-analysis.
D
The rationale to set analytical performance specifications based on biology is:
a. To minimize the analytical noise to the biological signal.
b. Because this is the best way to measure patient outcomes.
c. Because most differences between two serial results from a patient can be explained by biological variation.
d. Because otherwise it is not possible to estimate total error.
e. Because it is the easiest way.
A
Select all that apply of the following statements.
a. The Biological Variation Data Critical Appraisal Checklist (BIVAC) may be used as a tool to appraise the quality of biological variations studies.
b. The BIVAC primarily focuses on the effect of study design and statistical handling on estimates for between-subject variation.
c. An overall BIVAC grade D indicates that the publication is BIVAC compliant and that data are fit for purpose.
d. The BIVAC consists of 14 quality items.
e. The BIVAC can be used to calculate the withinsubject variation.
A,D