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BLD 313 Exam 2 > Exam 2 > Flashcards

Exam 2 Flashcards

1
Q

Which of individuals should be excluded when establishing a normal reference range for blood pressure?

A

A person who has smoked for two years

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2
Q

To test for subclass difference between the calcium reference values for men and women, the means standard deviations of each group used to calculate a z value of 6.0. While the z critical value is 3.0. What should be considered?

A

Separate reference intervals for men and women should be considered

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3
Q

Which of the following can be used to partition groups into subclasses when establishing a normal range of Hb?

A

Age

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4
Q

For most analytes, the upper and lower reference limits are estimated to enclose what percentage of the values for a population from which reference subjects have been drawn?

A

95%

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5
Q

What is used to determine a cut-off that will discriminate diseased from non-diseased when there is a significant overlap between the two populations?

A

Receiver operated characteristic curve

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6
Q

Which points on the ROC curve represent the cutoff value that provides the greatest diagnostic accuracy?

A

The point closest to the upper left-hand corner of the plot

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7
Q

The 95% confidence limit for calcium in control sera is reported as 8.0-10.0mg/dL. What is the value of the coefficient of variation (CV) for this data?

A

11%

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8
Q

What is the best description of random errors?

A

Imprecision

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9
Q

If your medical requirements for glucose require that the total error be less than 6mg/dL. What is the maximum bias that your method can have?

A

2.08mg/dL

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10
Q

Consensus error can be calculated by which of the following?

A

Mean and SD

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11
Q

What is true about quality control?

A

It is the personal who performs the test, evaluates testing quality himself and documents the process for inspection

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12
Q

What test can be used to interpret internal quality control data?

A

Level-Jennings

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13
Q

A patients bilirubin level on the first day was 2.omg/dL. The next day the same test was done and his bilirubin level was 7.0mg/dL. What should be done?

A

Perform delta check

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14
Q

Who sets up standards for laboratory personnel, quality control and quality assurance based on test complexity and potential harm to the patient?

A

CLIA’88

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15
Q

Who is responsible for inspection and certification of the clinical laboratories?

A

CMS

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16
Q

Which of the following acts as a scientific authority and educational resource in administering CLIA’88 by conducting research and analysis and providing technical expertise?

A

CDC

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17
Q

What should NOT be included in PT plan

A

Share PT results with laboratories of peer group

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18
Q

What is most often designated as the target value for most analytes in quantitative PT?

A

Peer Group Mean

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19
Q

The peer group results of a PT event are 1.6, 1.4, 1.3, 1.2, 1.0, 1.3, 1.2, 1.2, 3.6, 1.1, and 0.8mg/dL. The acceptance limits are target value +/- 0.3mg/dL or +/- 20%, whichever is greater. How many laboratories among this peer group have failed this PT event?

A

3

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20
Q

Your laboratory participate a PT for detecting an antibody commonly found in rheumatoid arthritis. You receive five samples and test all five of them positive. Among the fifty laboratories participating the same PT, forty two laboratories use the same testing kit A as your laboratory, and the other eight laboratories use the testing kit B. Among the forty two laboratories using kit A, forty laboratories test the same four samples positive and one sample negative. What is the PT score?

A

80

21
Q

Your laboratory received the following PT scores on the same testing in three months: 2017/1, 100%; 2017/2, 50%; 2017/3, 70%. As a laboratory manager, what should you do?

A

Discontinue the testing

22
Q

IQCP applies to which of the following tests?

A

All non-waived tests except for anatomic pathology and cytopathology

23
Q

What is part of risk assessment of IQCP?

A

Identify source of errors

24
Q

What statement about method evaluation is correct?

A

It is an essential part of QA process

25
Q

What statement is NOT true about medically allowable error?

A

It is established by CLIA

26
Q

What is an example of random error?

A

An error caused by variations in reagents

27
Q

What term is equivalent to imprecision?

A

Random error

28
Q

For 20 replicate measurements of a sample, the mean is 100.0mg/dL, a standard deviation is 1.0mg/dL

A

4.0mg/dL

29
Q

A blood sample is divided into two aliquots. One aliquot is analyzed directly; another one is analyzed after being physically traumatized. Which of the following does this experiment try to estimate?

A

Constant error

30
Q

Two 0.9ml aliquots of the same specimen are placed in test tubes. To one is added 0.1 ml of water (specimen A). To the other is added 0.1ml of 200 mg.dl urea (specimen B). Both specimens are analyzed for their urea content with the following results.
Specimen A= 25mg/dl
Specimen B= 43 mg/dl
What is the percent recovery of this method?

A

90%

31
Q

Which subdivision of the FDA, are direct issues concerning clinical laboratory testing addressed?

A

In vitro diagnosis

32
Q

What is the primary factor that would place a product/test/instrument in the FDA class 3?

A

No predicate

33
Q

What is NOT part of a typical investigation device exemption (IDE) for a product undergoing the FDA approval process?

A

Analytical performance

34
Q

Which of the following is part of pre market approval (PMA) for a product undergoing the FDA approval process?

A

Clinical trials

35
Q

A POCT coordinator distributed 1000 newly FDA approved glucometers. The users reported getting shocked when operating them. What should the coordinator do?

A

Return the two meters to the manufacturer who replaces them and report to the FDA of the defective devices

36
Q

Who is responsible for the evaluation and overview of laboratory developed tests in clinical laboratories?

A

CLIA

37
Q

What is NOT a part of literature review when seeking approval for a LDT?

A

Reportable range

38
Q

What best defines analytic sensitivities?

A

The concentration of analyze that represents the lower limit of the normal reference range

39
Q

What best describes the reportable range of an assay?

A

The range of concentration bound by the upper limit of linearity and the lower limit of detection

40
Q

What best describes the method for documentation of precision needed for CLIA approval of a LTD?

A

Repeated measurement of a single specimen done all in a single run at the same time

41
Q

A comparison of methods was done between the reference method and the method I seek to acquire LDT status for. This experiment produced a line of best fit with the corresponding formula Y=0.95X+0. What type of bias does my candidate for LDT status have?

A

A 5% negative proportionality error

42
Q

Looking at a package insert for an assay kit, it indicates that concentration of triglycerides greater than 500mg/dL causes significant interference. What is true of this value?

A

Results from specimens with concentrations of triglycerides greater than 500mg/dL are erroneous

43
Q

The distribution of values for a test from a normal population has been determined to be parametric. Determination of normal reference range would be best conducted by what method?

A

Plus and minus a two standard deviation interval about the mean

44
Q

What best describes critical value?

A

The concentration of an analyte above which is associated with acute negative patient outcomes

45
Q

What is pre-analytic variable which my influence the results of a test?

A

Time when blood is drawn

46
Q

What is true about surveillance protocols for LDTs is true?

A

Its primary purpose is to document and address negative patient outcomes

47
Q

What is true of governmental overview of laboratory testing?

A

Government overview is applied to those tests classified as waived

48
Q

What proficiency protocols would best satisfy CLIA regulations concerning participation in a proficiency testing program?

A

Establish a network with all the other labs where split specimens are shared three times per year and results are then compared

BLD 313 Exam 2 (1 decks)

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