Medical Relevance

Medical Relevance is the amount of total error that would cause a clinician to change a patient's diagnosis, prognosis, or treatment plan. Medical Relevance is based on confirming test imprecision within specified limits.

Use the Medical Relevance analytical goal to distinguish statistical error from medically important changes. Medical Relevance emphasizes clinical importance rather than statistical significance.

Note: Medical Relevance should be used with caution and only with the specific approval of the Laboratory Pathologist or Laboratory Director. Unity Real Time™ online does not define Medical Relevance limits. Each laboratory must define its decision limits based on local standards that define the degree of error that might cause the clinician to change the patient's diagnosis, prognosis, or treatment. The Laboratory Director or Pathologist should determine the laboratory's decision limits.

Medical Relevance limits are expressed as a percent or absolute value and are applied to a target mean. The software creates a chart with a single upper and lower limit of acceptability. The software plots the quality control data on a chart for retrospective evaluation.

Use this information to achieve the following:

• Alert the laboratory when a medically important error may have occurred.
• Identify the frequency of runs rejected by traditional single or multiple SPC rules.
• Distinguish statistical error from medically important error.
• Adjust the SPC rules used, thereby possibly reducing the frequency of recalibration, unnecessary troubleshooting, and retesting of patient samples.