Levey-Jennings Charts

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10 Questions

What is the Levey-Jennings Chart used to graph?

Successive QC results

What does good control results on a Levey-Jennings Chart look like?

Evenly distributed QC values about the mean and within +/- 1 SD limits

What constitutes a systematic error shift on a Levey-Jennings Chart?

6 consecutive results lying on the same side of the mean within +2SD limits

When should an analytical run be rejected based on QC values?

If just 1 QC value is outside 2SD but within the 3SD limit

What does a trend on a Levey-Jennings Chart indicate?

Gradual loss of reliability of the test system

What is the main cause of a systematic error shift on a Levey-Jennings Chart?

Changes in reagent

How many consecutive results lying on the same side of the mean indicate a systematic error shift on a Levey-Jennings Chart?

6

In what situation should an analytical run not be rejected based on QC values on a Levey-Jennings Chart?

Just 1 QC value is outside 2SD but within the 3SD limit

What does a trend on a Levey-Jennings Chart indicate?

Gradual loss of reliability of the test system

When are test results still considered in-control on a Levey-Jennings Chart?

If QC values are within +2SD limits and there are no shifts or trends

Study Notes

Levey-Jennings Chart

  • Used to graph quality control (QC) data over time, allowing for the detection of trends and shifts in analytical performance.

Good Control Results

  • Randomly scattered around the mean, with an equal number of points above and below the mean.
  • No systematic pattern or trends, indicating analytical performance is within acceptable limits.

Systematic Error Shift

  • A consistent deviation from the mean, indicating a problem with the analytical process.
  • Constituted by 7 or more consecutive results lying on the same side of the mean.
  • Typically caused by a problem with the instrument, reagents, or analytical technique.

Rejecting an Analytical Run

  • An analytical run should be rejected if the QC values exceed the acceptable limits or show a systematic error shift.
  • Rejection is necessary to prevent erroneous results from being reported.

Trend Identification

  • A trend on a Levey-Jennings Chart indicates a gradual change in analytical performance over time.
  • May be due to instrument drift, reagent degradation, or other factors, and requires corrective action.

Analytical Run Acceptance

  • An analytical run should not be rejected based on QC values if the results are within acceptable limits and show no systematic error shift.
  • Results are still considered in-control if the QC values are within the acceptable range and show no trends or shifts.

Test your knowledge of data handling and method evaluation with this quiz on Levey-Jennings charts. Learn about interpreting QC values, identifying shifts, and understanding systematic errors. Master the concepts necessary for ensuring accurate and reliable test results.

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