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Lab Ops: Quality & LIS (answer w/ term) Questions and answers
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Lab Ops: Quality & LIS (answer w/ term) Questions and answers 1. Total quality management (TQM) is a managerial process that focuses on improvement of the quality of all factors that affect laboratory testing and performance. It consists of five elements: quality laboratory process, quality contr...

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  • December 29, 2024
  • 7
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers

Subjects

  • lab ops quality lis answer w term questions
  • 1 total quality management tqm is a managerial
  • 2 quality assessment qa this is a systemic lab

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  • Laboratory management
  • Laboratory management

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Lab Ops: Quality & LIS (answer w/ term)
Questions and answers
1. Total quality management (TQM) - answer is a managerial process that focuses
on improvement of the quality of all factors that affect laboratory testing and
performance. It consists of five elements: quality laboratory process, quality control,
quality assessment, quality improvement, and quality planning.

2. Quality assessment (QA): - answer This is a systemic laboratory program,
encompassing preanalytical, analytical, and postanalytical factors, that monitors
excessive variation in specimen acceptability, test methodologies, instruments,
reagents, quality control, and personnel competencies. This process is used to ensure
accurate patient test results.

3. Preanalytical error - answer occurs during sample collection and transport before
sample analysis and can include sample preparation and storage conditions.

4. Analytical error - answer occurs during the testing process and includes problems
related to reagents, instruments, controls, calibration, performance of personnel, etc.

5. Postanalytical error - answer occurs after the test is performed and refers to
clerical errors, reporting of results, test interpretation, etc.

6. Accuracy - answer is a measure of a laboratory test result's closeness to the true
value.

7. Precision - answer is realized when repeated laboratory test results yield the same
number; reproducibility.

8. Reliability - answer refers to the ability of laboratory testing to maintain accuracy
and precision over an extended period of time.

9. Quality control (QC): - answer A system used to monitor the analytical process to
detect and prevent errors that would impact on the accuracy and precision of laboratory
test results; includes both statistical and nonstatistical parameters.

a. Internal QC - answer is performed by laboratory personnel using control materials
of known values and comparing the control values to established, acceptable ranges.
The control material values are assessed using Levey-Jennings control charts and
Westgard multirules to detect errors.

b. External QC - answer is performed by laboratory personnel when analyzing
specimens sent to the laboratory by an external agency, and the results generated are

, submitted to the agency for assessment. This type of assessment is known as
proficiency testing. It is required by federal regulations for all laboratories providing
results for human diagnosis and/or treatment.

10. Linearity check - answer determines the lowest and highest values that can be
accurately measured by a particular method. This is an example of a nonstatistical QC
parameter.

1 1 . Random errors - answer affect precision, are unable to predict because they
have no known pattern, and may alternate between a positive or negative direction.

12. Systematic errors - answer are predictable and cause a constant difference in
results that are consistently positive or negative or stay the same. Such errors may be
due to incorrect calibration, deteriorated reagents, instrument malfunction, etc.

13. Delta check - answer assesses the patient's most recent result for a particular
test as compared to the patient's previous value; the difference between the test results
(delta) is calculated and compared to established limits.

14. Reference ranges - answer are determined by each laboratory to fit their
particular population. Intervals are generally constructed by adding and subtracting 2
standard deviations from the mean

15. Standard - answer is material of known concentration (should be traceable to
NIST) that is used to calibrate an instrument or develop a standard curve.

16. Control - answer is material of known value that is analyzed with patient samples
to determine acceptability of results.

a. Assayed control: - answer Values are assigned by the manufacturer.

b. Unassayed control: - answer Values are determined by each individual laboratory
for their methods/instruments.

17. Westgard multirules - answer are statistical "rules" applied to graphical
summaries of numerical quality control data to assess the acceptability of such data.

18. Six Sigma - answer is a data-driven, business approach to performance
improvement; it is oriented toward process identification and process improvement.

19. Lean principles - answer are an improvement trend to make work faster by
providing ways to streamline through the removal of waste.

20. ISO 9000 Standards - answer were established by the International Organization
for Standardization as a series of four standards for quality management.

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