Continuing Education for Laboratory Professionals – How Workbooks Can Help.

Building skillsets of lab professionals with workbooks

Workbooks include course material that explains key topics with specific examples and knowledge checks, allowing readers to make progress at their own pace.

Participants will gain a better understanding of various topics related to laboratory quality control. Laboratory professionals who are committed to achieving a higher standard of quality and improved reliability of patient test results, will find valuable background information in this workbook series.

The first workbook focuses on the basics of quality control statistics and its application in clinical labs. It is intended for those who are new to the laboratory or as a refresher for existing staff.

The workbook covers topics including:

• Definition, calculation, and application of statistical terms
• Description and review of the different QC statistical rules
• How to construct a Levey-Jennings chart and how to evaluate graphed data for out-of-control events

A new digital resource is the electronic workbook, "Basic Statistics in Clinical Laboratory Quality Control". The workbook is part of a series in development by Bio-Rad Laboratories to provide continuing education focused on laboratory quality control in an accessible and easy-to-use format. The QC workbook series is digitally designed and available online as an interactive series provided at no cost to learners.

The following figure illustrates two examples of how QC rules 13s and 12s are explained.

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  Figure 1. This rule identifies unacceptable random error or possibly the beginning of a large systematic error. Any QC result outside ±3s violates this rule and should be rejected.

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  Figure 2. This is a warning rule that is violated when a single control observation is outside the ±2s limits. Remember that in the absence of added analytical error, about 4.5% of all quality control results will fall between the 2s and 3s limits. This rule merely warns that random error or systematic error may be present in the test system. The relationship between this value and other control results within the current and previous analytical runs must be examined. If no relationship can be found and no source of error can be identified, it must be assumed that a single control value outside the ±2s limits is an acceptable random error. Patient results can be reported.

Figure 3

Individuals will also learn how to identify which statistical rules detect random error and which rules detect systematic error. The workbook explains the differences between trends and shifts (see figure 2) and the potential causes described in detail.

The knowledge checks, which are included at different places in this workbook, aim to evaluate the learner’s understanding and knowledge of the presented topics.

As an example, two practice evaluation charts (Figure 3) are included after the section discussing QC rules ∓ Levey- Jennings charts.

Participants need to study the Levey- Jennings charts to evaluate the last run QC (Run Number 12) context with the preceding runs. They are then asked to identify whether a QC rule was violated and if so, which one and identify the type of error most likely associated with the control rule violations.

Rule Violated: a) 3_1s, b) 1_3s, c) 1_2s
Error: a) Random or Large Systematic, b) Warning, c) Systematic

Rule Violated: a) None, b) 1_3s, c) 1_2s
Error: a) None, b) Systematic, c) Random

In this example, the correct answers are:

chart 1: Rule Violated: 13s
Error: Random or Large Systematic

chart 2: Rule Violated: None
Error: None

Another topic is the evaluation of within-lab precision using the coefficient of variation ratio and the evaluation of laboratory trueness using the standard deviation index. The formulas, specific factors, practical examples and interactive self-tests are in detail.

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  The standard deviation index (SDI) is a peer-based estimate of reliability. If the peer group mean is defined as x̄_Group, the standard deviation of the group is defined as s_Group and the laboratory’s mean is defined as x̄_Lab.

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  One way a laboratory can determine whether the precision of a specific test is acceptable is to compare its precision to that of another laboratory performing the same test on the same instrument using the same reagents (laboratory peer group). An easy way to make this comparison is to divide the laboratory CV by the laboratory peer group CV obtained from an interlaboratory comparison report.

Finally, the QC statistics workbook reviews QC Crossover Studies (QC Lot Change Studies), how they are performed and an explanation on the number of data points needed, with or without historical QC data, as recommended by the guidance document, CLSI C24.

After completing the reading and knowledge checks, the individual is directed to a link to an exam consisting of 20 questions. Successful completion of the exam with a score of 70% or higher is required to receive 2.5 P.A.C.E. continuing education credits and a Certificate of Completion.

The second workbook in the series is also available. This workbook provides a detailed discussion on the types of QC materials, considerations for selection of QC material and proper handling. The second workbook is approved for 2 P.A.C.E. continuing education credits.

The online workbooks will be accessible on computers and tablets, and for offline learners or future reference, a pdf file can be downloaded.