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Clinical Chemistry > Quality Control > Flashcards

Quality Control Flashcards

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1
Q

Important elements of a quality management system.

A

Documentation
Standard operating procedures (SOPs)
Quality control samples
External quality assessment scheme

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2
Q

These are written instructions that detail the steps to be performed during a given experimental procedure.

A

Standard operating procedures (SOPs)

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3
Q

A systematic monitoring of analytic processes to detect analytic errors that occur during analysis and to ultimately prevent the reporting of incorrect patient test result.

A

Quality Control

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4
Q

Components of a control solution or material.

A
  1. Available (usually commercially)
  2. Liquid, frozen or lyophilized
  3. Patient-like (ideally made from human serum, urine or spinal fluid)
  4. Composed of 1 or more constituents or analytes of known concentration
  5. Tested in the same manner as patient sample
  6. Packaged in small bottles suitable for daily uses
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5
Q

A specimen or solution which is analyzed solely for quality control purposes and not for calibration.

A

Control solution or control material

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6
Q

How do monitoring of analytic methods are performed?

A
  1. Assaying stable control materials

2. Comparing determined valued with their expected values

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7
Q

Degree of correctness of a lab result

A

Accuracy

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8
Q

What agency is considered as the national reference laboratory for clinical chemistry?

A

Lung Center of the Philippines

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9
Q

What is the foundation for monitoring performance?

A

Quality Control

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10
Q

These are ways of describing the central position of a frequency distribution for a group of data.

A

Measures of central tendency

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11
Q

Refers to how tightly clustered several replicates are, whether or not they are close to the true value.

A

Precision

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12
Q

This is used as a description of the center of a dataset and is considered as the middle point of the data.

A

Median

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13
Q

It is a gradual movement in one direction, either upward or downward, by a set of six or more consecutive data points

A

Trend

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14
Q

What is the purpose of Levey-Jennings chart?

A

Levey-Jennings chart makes it easy to spot outliers, trends, and shifts in the data, with the ultimate goal of showing whether an analytical method is working properly.

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15
Q

What is the administrative order that mandates every clinical laboratory to participate in an External Quality Assessment Program (EQAP) provided by the NRLs?

A

AO 2007-0027 (Revised Rules and Regulation Governing Licensure and Regulation of Clinical Laboratories in the Philippines)

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16
Q

The expected values are presented by intervals of acceptable values with upper and lower limits known as _______.

A

Control limits

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17
Q

It is an abrupt move in which six or

more consecutive data points all occur above or below the mean

A

Shift

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18
Q

This is used as a description of the spread of a dataset and is often a good measure of dispersion of small samples of data.

A

Variance

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19
Q

This agency requires a laboratory to have quality control (QC) procedures to monitor the accuracy and precision of the complete testing process.

A

Clinical Laboratory Improvement Amendments (1988)

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20
Q

Degree of reproducibility in repeated measurements

A

Precision

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21
Q

Where is median often used with?

A

Skewed data

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22
Q

Two notions that are tightly connected to quality control in the laboratory.

A

Accuracy and Precision

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23
Q

These are ways of summarizing a group of data by describing how spread out the values are.

A

Measures of spread

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24
Q

How do you calculate to get the median in odd number of values in the sample? In even number of values ?

A
  1. Values are rank ordered from least to greatest and the middle value is selected.
  2. Values are rank ordered from least to greatest and the two middle values are selected and divided in two.
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25
Q

It is the analysis of data that helps describe, show or summarize data in a meaningful way.

A

Descriptive Statistics.

26
Q

Three most commonly used descriptions of spread.

A
  1. Range
  2. Standard deviation
  3. Coefficient of variation
27
Q

What does low value of SD mean?

A

On average, the data lie clustered around the mean.

28
Q

(T/F). After describing the center of the dataset, it is very useful to indicate how the data are distributed (spread).

A

True

29
Q

What are expressed as the mean ±SD using statistical formula?

A

Control limits

30
Q

Refers to how close a laboratory value is to the true value

A

Accuracy

31
Q

Assesses performance against other laboratories using the same method and instrument, by analyzing ‘blind’ samples as if they were patient samples.

A

External Quality Assessment

32
Q

How do you calculate to get the mean?

A

By summing the observations and dividing by the number of the observations.

33
Q

It is the most frequently occurring value in a dataset.

A

Mode

34
Q

Reveals the quality of the measurement behind that result

A

Precision

35
Q

(T/F). Not all clinical laboratories are required to participate in order to receive a certification that verifies their clinical laboratory as having good quality control.

A

False. All clinical laboratories must participate.

36
Q

The SD and, more specifically, the variance represent the _______ distance from the center of the data (the mean) and every value in the dataset.

A

average

37
Q

What is plotted on the x and y axis of the Levey-Jennings chart?

A

x-axis: Day that you run the control

y-axis: Control limits according to the SDs

38
Q

These are points that lie outside the acceptable range.

A

Outliers

39
Q

(T/F). Descriptive statistics allow us to make conclusions beyond the data we have analyzed or reach conclusions regarding any hypotheses we might have made.

A

False. Descriptive statistics do not allow us to make conclusions. Descriptive statistics are only a simple way too describe data.

40
Q

Examples of number statistics used to describe the spread.

A
  1. Range
  2. Quartiles
  3. Absolute deviation
  4. Variance
  5. Standard deviation
41
Q

It allows a laboratorian to compare SDs with different units.

A

Coefficient of variation

42
Q

(T/F). The clinical laboratory only seeks for accuracy, in which case the measurements are all close to, and tightly grouped around, the true value.

A

False. The clinical laboratory seeks for both accuracy and precision.

43
Q

It is also called normal distribution. Its distribution is symmetric—meaning half the values fall to the left of the mean and the other half fall to the right.

A

Gaussian distribution

44
Q

Systems of multiple rules that have been developed to keep the rate of error detection high and rate of false rejection low.

A

Multirules

45
Q

It graphically represent the observed values of a control material over time in the context of the upper and lower control limits.

A

Control charts

46
Q

This is a rarely used description of the center of a dataset and is often used to describe data that seem to have two centers.

A

Mode

47
Q

Regulation of clinical laboratories in the Philippines is mandated by what RA?

A

RA 4688 (Clinical Laboratory Law of 1966)

48
Q

Patterns of descriptive statistics might emerge from the data, and these patterns can be described by their _______, _______, and _______.

A

Center, spread, shape

49
Q

The most commonly used description of the center of a dataset and is often called the average.

A

Mean

50
Q

Reveals the quality of a result

A

Accuracy

51
Q

It is the most frequently used measure of variation.

A

Standard Deviation

52
Q

It indicate the number of control observations per analytic run, followed by the control amount in subscript.

A

Control rules

53
Q

It is the largest value in the data minus the smallest value, which represents the extremes of data one might encounter.

A

Range

54
Q

What is the symmetrical shape in the Gaussian distribution called?

A

Bell shape

55
Q

Examples of number statistics used to describe the central position.

A
  1. Mean
  2. Median
  3. Mode
56
Q

A rule that summarizes the relationships between the area under a Gaussian distribution and the SD.

A

68-95-99 Rule.

Much of the area—68.3%—under the “normal” curve is between ±1 SDs.
Most of the area—95.4%—under the “normal” curve is between ±2 SDs.
And almost all of the area –99.7% -under the “normal” curve is between ±3 SDs.

57
Q

It is a graphical representation of the results over a certain period of time.

A

Levey-Jennings chart

58
Q

What is the total value under the Gaussian curve?

A

1.0 or 100%

59
Q

It is the average of the squared distances of all values from the mean.

A

Variance

60
Q

What does high value of SD mean?

A

On average, the data lie far from the mean.

Clinical Chemistry (3 decks)

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