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Clinical Chemistry > Quality In The Laboratory > Flashcards

Quality In The Laboratory Flashcards

1
Q

A management philosophy and approach that focuses on processes and their improvement as the means to satisfy customer needs and requirements.

A

Total Quality Management (TQM)

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2
Q

It include analytical processes and the general policies, practices, and procedures that define how all aspects of the work are done.

A

Quality Laboratory Processes (QLP)

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3
Q

Emphasizes statistical control procedures (QC procedures), but also includes nonstatistical check procedures, such as linearity checks, reagent and standard checks, and temperature monitors.

A

Quality control

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4
Q

Concerned primarily with broader measures and monitors of laboratory performance

A

Quality Assessment

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5
Q

Provides a structured problem-solving process to help identify the root cause of a problem and a remedy for that problem.

A

Quality Improvement

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6
Q

“set of key and quality elements that must be in place for an organization’s work operations to function in a manner to meet the organization’s stated quality objectives.”

A

Quality Management System

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7
Q

A comprehensive program in an institution in which all areas of operation are monitored to ensure quality with the aim of providing the highest quality patient care.

A

Quality Assurance

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8
Q

Set of instructions for methods used in the laboratory. Also known as procedure manual

A

Standard Operating Procedures

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9
Q

Training, Calibration and Maintenance are examples of what quality costs:

A

Prevention cost

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10
Q

Inspection and Quality Control are examples of what quality costs:

A

Appraisal costs

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11
Q

Scrap, Rework and Repeat runs are examples of what quality costs:

A

Internal failure costs

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12
Q

Complaints, Service and Repeat Request are examples of what quality costs:

A

External Failure Costs

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13
Q

Increasingly used to reduce error (Six Sigma) and waste (Lean)

A

Lean Six Sigma

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14
Q

The major measurement for Lean:

A

Time

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15
Q

A performance improvement program, the goal of which can be summarized by the mantra “improvement by eliminating process variation”: improved performance, improved quality, improved bottom
line, improved customer satisfaction, and improved employee satisfaction . it is oriented toward process identification and process improvement.

A

Six Sigma

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16
Q

Process improvement in six sigma

A

DMAIC
Define
Measure
Analyze
Improve
Control

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17
Q

A system ensuring accuracy and precision. It is used to monitor the analytic variations that can occur with a new instrument or with new lots of control.

A

Quality control

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18
Q

Measures the smallest concentration

A

Sensitivity

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19
Q

Ability to measure only the analyte of interest

A

Specificity

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20
Q

Nearness or closeness of the assayed value to the true value

A

Accuracy

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21
Q

Ability to give repeated results on the same sample that agree with one another

A

Precision/Reproducibility

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22
Q

High SD and CV

A

Poor precision

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23
Q

Low SD and CV

A

Good precision

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24
Q

Refers to the ability of laboratory testing to maintain accuracy and precision over an extended period of time.

A

Reliability

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25
Q

Ability to detection proportion of individuals w/that disease.

A

Diagnostic Sensitivity

26
Q

The percentage of people with positive test results who have the disease.

A

Positive predictive value

27
Q

Ability to detect the proportion of individual w/o the disease who test negatively for the disease.

A

Diagnostic specificity

28
Q

The percentage of people with negative test results who do not have the disease

A

Negative predictive value

29
Q

Determines the lowest and highest values that can be accurately measured by a particular method.

A

Linearity check

30
Q

A quality program in which specimens are submitted to laboratories for analysis and the results of an individual laboratory are compared with the results for the group of participating laboratories.

A

External quality assessment

31
Q

Specimens that have known concentrations of an analyte for the test of interest. The testing laboratory does not know the targeted concentration when tested.

A

Proficiency samples

32
Q

Analyses of control w/patient sample

A

Intralab

33
Q

Due to chance. Arises from unpredictable variations of influence quantities. Error that doesn’t recur in regular pattern; affect precision.

A

Random error

34
Q

Consistent in one direction or varies in a predictable way. Recurring error inherent in test procedure.

A

Systematic error

35
Q

Handwritten labels and request forms

A

Clerical error

36
Q

The science of gathering, analyzing, interpreting and presenting data

A

Statistics

37
Q

Measure of central tendency, symmetrical or normal distribution

A

Mean

38
Q

Difference between the observed mean and the reference mean

A

Bias

39
Q

The middle value in a set of numbers that are arranged according to their magnitude

A

Median

40
Q

The most frequently obtained value in a set of numbers

A

Mode

41
Q

Measure of the dispersion of values from the mean . Reflects the variation of data values around the mean.

A

Standard Deviation

42
Q

Percentile expression of the mean, an index of precision.

A

Coefficient of variation

43
Q

Standard deviation squared, a measure of variability reflects dispersion around the mean

A

Variance

44
Q

Indicate the extent of variation of the observations:

A

SD
Variance
Range

45
Q

Where independent variable is plotted

A

Abscissa/X –axis

46
Q

Where dependent variable is plotted

A

Ordinate/Y-axis

47
Q

Data elements are Centered around the mean. Most common shape.

A

Gaussian Curve (bell shaped curved)

48
Q

Difference between QC results and target mean. Requires computer.

A

Cumulative Sum Graph (CUSUM)

49
Q

Used to compare results obtained Control results from different lab.

A

Youden/Twin plot

50
Q

QC chart in the clinical lab

A

Shewhard Levey-Jennings Chart

51
Q

Range within which control values must fall for assay to be considered valid.

A

Control limits

52
Q

Obvious on the chart when control values become more disperse

A

Loss of precision

53
Q

Control values that either increase or decrease for 6 consecutive days

A

Trend

54
Q

Main cause of trend:

A

Expiring reagent

55
Q

Control values that distribute on one side or side of the mean for 6 consecutive days

A

Shift

56
Q

Main cause of shift:

A

Improper or wrong calibration

57
Q

Far from the main set of values.

A

Outliers

58
Q

A systematic error:

A

Trend and shift

59
Q

Random or systematic error:

A

Outliers

60
Q

Most commonly used patient based-QC technique.

A

Delta check

61
Q

Most commonly used POCT

A

Glucose

Clinical Chemistry (6 decks)

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