Dr. Rhoads has prepared a 125-page training manual on Clinical Laboratory Statistics -- great either as a reference or as a text for medical technology classes. It covers following topics:

• Chapter 1. Regulations.
  A review of the CLIA '88 regulations relevant to method validation and quality control.

• Chapter 2. Statistics 101.
  A review of statistics related to method validation and quality control.

• Chapter 3. Understanding Experimental Error.
  Development of the concepts of experimental error and how it can be managed. Included is a discussion of the 25% rule which greatly simplifies the process of setting target values for quality control materials.

• Chapter 4. Setting Quality Control Limits.
  Understanding the quality control process including setting target means and SDs for quality control materials.

• Chapter 5. Method Validation Experiments.
  Which experiments must be done to validate clinical laboratory methods?

• Chapter 6. Linearity Style Experiments.
  Design and interpretation of experiments to establish or verify claims for linearity, accuracy and reportable range.

• Chapter 7. Precision Style Experiments.
  Design and interpretation of experiments to establish or verify claims for precision.

• Chapter 8. Reference Interval Experiments.
  Design and interpretation of experiments to establish or verify reference intervals (normal ranges).

• Chapter 9. Sensitivity Experiments.
  Design and interpretation of experiments to establish claims for limits of detection (i.e. the lowest concentration significantly different from zero, also known as "analytical sensitivity") and limits of quantitation (i.e. the lowest concentration which can be reliably quantitated, also known as "functional sensitivity").

• Chapter 10. Method Comparison Experiments.
  Design and interpretation of method comparison experiments. This topic also defines the statistics calculated in method comparison experiments and lists those that are most important. Also included are several example reports to illustrate problems encountered in method comparison experiments.

• Appendix
  CLIA '88 PT limits and the technically oriented portions of the CLIA '88 regulations.

The manual is available separately, or in conjunction with a one-day workshop conducted by Dr. Rhoads. Call if you are interested in having a workshop in your area.