Quality Management Flashcards

1
Q

All laboratory’s policies, processes, procedures, and resources needed to achieve quality testing.

A

Quality Management System

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2
Q

The overall process of guaranteeing quality patient care and is regulated throughout the total testing system.

A

Quality assessment

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3
Q

What organization replaced the terms of the three stages of testing into preanalytical, analytical, and postanalytical?

A

International Organization for Standardization

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4
Q

What stage of testing occurs before the actual testing of the specimen?

A

Preanalytical

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5
Q

What stage of testing directly affects the testing of specimens?

A

Analytical

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6
Q

What stage of testing affects the reporting of results and correct interpretation of data?

A

Postanalytical

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7
Q

Enumerate all accreditation agencies requiring documentation of QA procedures.

A

Joint Commission (JC)
College of American Pathologists (CAP)
American Association of Blood Banks (AABB)
American Osteopathic Association (AOA)
American Society of Histocompatibility and Immunogenetics (ASHI)
Commission on Laboratory Assessment (COLA);

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8
Q

What refers to the amount of time required from the point at which a test is ordered until the results are reported?

A

Turnaround Time (TAT)

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9
Q

The sample that is chemically and physically similar to an unknown specimen and is tested in exactly the same manner.

A

Control

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10
Q

Identify the Quality Control:

  • Testing control material not built into test system.
A

External QC

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10
Q

Identify the Quality Control:

  • QC that extend beyond the system
A

External QC

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11
Q

Identify the Quality Control:

  • Proficiency testing program
A

External QC

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12
Q

Identify the Quality Control:

  • electronic, internal, or procedural controls that are built into test system.
A

Internal QC

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13
Q

Identify the parameter of QC:

  • Nearness or closeness of assayed value to the true or target value
A

Accuracy

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14
Q

Identify the parameter of QC:

  • Give repeated results on the same sample that agree with one another.
A

Precision

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15
Q

Identify the parameter of QC:

  • Measure the smallest concentration of the analyte of interest.
A

Sensitivity

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16
Q

Identify the parameter of QC:

  • Ability to measure only the analyte of interest.
A

Specificity

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17
Q

Enumerate the measures of center.

A

Mean
Median
Mode

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18
Q

What refers to the materials, procedures, and techniques that monitor the accuracy, precision, and reliability of a laboratory test?

A

Quality Control

19
Q

Enumerate the indication of changes in accuracy.

A

Trend and Shift

20
Q

What refers to the gradual changing in the mean in one direction?

A

Trend

21
Q

What refers to the abrupt change in the mean?

A

Shift

22
Q

Identify the Quality Control:

  • verify the accuracy (ability to obtain the expected results) a precision (ability to obtain the same results on the same specimen) of a test
A

External Quality Control

23
Q

Identify the measure of center.

  • average of all data points
A

Mean

24
Q

Identify the measure of center.

  • data point that separates the upper half from the lower half of a data series
A

Median

25
Q

Identify the measure of center.

  • data point that appears most often in the sample
  • not a true measure of central tendency
A

Mode

26
Q
  • Statistical parameters decribing spread of data.
  • Measurement of precision
A

Measures of Dispersion

27
Q

Enumerate the measures of dispersion.

A

Standard Deviation (SD)
Coefficient of Variation (CV)
Range

28
Q

Identify the measures of dispersion.

  • a measurement statistic that describes the average distance each data point in a normal distribution is from the mean.
A

Standard Deviation

29
Q

Identify the measures of dispersion.

  • the SD expressed as a percentage of the mean.
A

Coefficient of Variation (CV)

30
Q

Identify the measures of dispersion.

  • indicates whether the distribution of values about the mean is in a narrow versus broad range and should be less than 5%.
A

Coefficient of Variation (CV)

31
Q

Identify the measures of dispersion.

  • Difference between highest and lowest values in data set.
A

Range

32
Q

Identifies and evaluates potential problems that may occur in the entire testing process from reexamination through the examination and post-examination processes.

A

Risk Assessment

33
Q

Establishes control procedures to reduce the possibility of reporting an inaccurate patient test result.

A

Quality Control Plan

34
Q

What study verifies the accuracy of the new method?

A

Correlation study

35
Q

The testing of samples from an outside agency and the comparison of results with participating laboratories is called:

A

Proficiency testing (PT)

36
Q

These are set of instructions for methods used in the laboratory.

A

Standard Operating Procedure (SOP)

37
Q

Process of testing and adjusting analyzer’s readout to establish a correlation between measured and actual concentrations.

A

Calibration

38
Q

Reference material with a known concentration of an analyte.

A

Calibrator

39
Q

Testing materials of known concentrations to ensure the accuracy of results throughout the reportable range.

A

Calibration verification

40
Q

A color change that indicates that a sufficient amount of the patient’s specimen or reagent is added correctly to the test system would be an example of:

A. External QC
B. Equivalent QC
C. Internal QC
D. Proficiency testing

A

C. Internal QC

41
Q

What steps are taken when the results of reagent strip QC are outside of the stated confidence limits?

A. Check the expiration date of the reagent strip B. Run a new control
C. Open a new reagent strips container
D. All of the above

A

D. All of the above

42
Q

When a new bottle of QC material is opened, what information is placed on the label?
A. The supervisor’s initials
B. The lot number
C. The date and the laboratory worker’s initials
D. The time the bottle was opened

A

C. The date and the laboratory worker’s initials

43
Q

When control is run, what information is documented?

A. The lot number
B. Expiration date of the control
C. The test results
D. All of the above

A

D. All of the above

44
Q

True or False.

Changes in precision are shown by a large amount of scatter about the mean and an uneven distribution above and below the mean that is most often caused by errors in technique.

A

True