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MLS 220 Clinical Lab Operations > Lecture 11a - Quality Part 1 > Flashcards

Lecture 11a - Quality Part 1 Flashcards

1
Q

What are the three phases of the total testing process?

A
  1. Pre-analytical
  2. Analytical
  3. Post-analytical
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2
Q

Which analytical phase is most likely to contain human error?

A

Pre-analytical Phase

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3
Q

What is the Pre-Analytical Phase?

A

The “prior to testing” phase.

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4
Q

What are some examples the pre-analytical phase?

A

Test ordering, specimen collection, sample labeling, checking patient identifiers.

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5
Q

What is the analytical phase consist of?

A

The “testing of the sample” phase.

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6
Q

Which phase in the total testing process has the least amount for potential human error?

A

Analytical Phase

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7
Q

What is the post-analytical phase consist of?

A

The “after testing is complete” phase.

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8
Q

Define Quality Assurance

A

Policies, procedures, and practices necessary to make sure that a laboratory’s results are reliable.

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9
Q

What is a QA program?

A

A plan to carry out policies and practices necessary to comply with QA standards set by accreditation agencies.

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10
Q

What is a Delta Check?

A

The difference between a patient’s current laboratory result and consecutive previous results that exceeds a specified cutoff value.

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11
Q

What is proficiency testing?

A

A sample is provided and the test is performed using the same method and procedure that is used for a patient. The results are submitted back to the agency, and the results are reviewed and communicated back. (CLIA requirement)

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12
Q

What is quality control?

A

Detecting and correcting errors; alerts analyst when there may be a problem with a testing procedure. Makes sure results are highest quality and most accurate.

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13
Q

What is internal QC (statistical)

A

Evaluates the DAILY precision of an assay.

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14
Q

What is External QC?

A

Evaluates the accuracy of assay measurements; requires submission of internal QC results and specified control specimens (ex: proficiency testing).

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15
Q

What are important characteristics to note when handling QC?

A
  1. Both levels are used.
  2. Make sure new lots are addressed
  3. Expiration date (open/expire dates)
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16
Q

How often must two levels of QC be ran?

A

Daily; for automatic analyzers bi-levels controls can be ran once every 8 hours.

17
Q

Why would QC be out of range?

A

Errors in equipment, reagents, or individual technique.

18
Q

What is a systematic QC error?

A

Caused by the same factor regularly producing reproducible error in one direction from the true value.

Ex: instrument calibrated incorrectly

19
Q

What is a random QC error?

A

Caused by an accident that can be difficult to identify.

Ex: inaccurate pipetting

20
Q

Define accuracy.

A

The closeness of the result obtained to the true or actual value.

Assessed using a “T-Test” - compares value of sample 1 on analyzer A vs. value of sample 1 on analyzer B.

21
Q

Define precision

A

Repeatability, or reproducibility, in obtaining the same value in subsequent tests on the same sample.

22
Q

Determine if this is accurate, precise, neither, or both.

A

Precise, but NOT accurate.

23
Q

Determine if this is accurate, precise, neither, or both.

A

Accurate, but NOT precise.

24
Q

Determine if this is accurate, precise, neither, or both.

A

Neither precise, nor accurate.

25
Q

Determine if this is accurate, precise, neither, or both.

A

Precise AND Accurate

26
Q

How is accuracy ensured in the clinical lab?

A

Standardized procedures, statistically valid comparisons of new methods with established reference methods, the use of controls, and participation in proficiency testing.

27
Q

How is precision ensured in the lab?

A

Proper inclusion of standards/reference samples, statistically valid replicate determinations of a single sample, duplicate determinations of sufficient numbers of unknown samples, and day-to-day and between-run precision assessed by inclusion of control specimens.

28
Q

Define what a standard is.

A

A highly purified substance of a known concentration purchased from a manufacturer.

29
Q

What is a benefit of using standards?

A
  1. The best way to measure accuracy

2. Used to establish reference points to construct graphs or to calculate a test result

30
Q

What is the difference between standards and QC material?

A

Standard concentration is typically a single value (very precise) vs. QC concentration is typically a range.

31
Q

What is a calibration?

A

It compares an instrument measurement/reading to a known concentration (standard)

32
Q

When is calibration ran?

A

Ran prior to quality control to assign a known value to an instrument output.

MLS 220 Clinical Lab Operations (28 decks)

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