Medical Laboratory Quality Management Programs

Method validation is a prerequisite for all methods/equipment involved in processing patient results. This is to guarantee the validity of test results in a medical laboratory. As a rule, the method/equipment developer conducts validation. However, laboratories are required to conduct independent verification of, and validate methods to confirm that the method/equipment can produce the intended results.

Measurement uncertainty on the other hand represents the doubt associated with test results due analytical and non-analytic factors that affects measurements in the laboratory. As rule, laboratory measurements provide a best estimate of a quantity of interest (such as Blood glucose test value or therapeutic drug measurements). Because these are estimates, there is always some uncertainty about how closely they represent the true value of the quantity. This forms the basis the for estimation of Measurement Uncertainty (MU). It is essential to account for measurement uncertainty to enable healthcare givers to determine the clinical significance of a test result value given the analytical factors that may have an influence on it.

Metrological traceability is used as the basis the for comparability of test results across different, methods/equipment and locations.

• Guarantees validity of test results
• A prerequisite for ISO 15189 accreditation
• Confirms that intended test results (by method developer) can be obtained by the lab
• Verification is necessary for equipment that has been subjected to reports, service and transportation to confirm acceptable functionality
• Helps clinicians make informed decisions on the clinical significance of test results
• Metrological   traceability   and   MU   are   essential   in   determining   the acceptability of calibration results for laboratory equipment
• MU is important in assessing the quality of results the lower the MU the better the results
• MU is essential in determining the performance of a method/equipment or even a laboratory compared to others
• It is an important aspect of Metrological traceability

By the end of this course, participants will:

• Understand the importance of method validation/verification.
• Understand the application of metrological traceability in laboratory medicine.
• Identify sources of MU.
• Recognize how and when to report and use MU.
• Be able to explain all of this to users of laboratory services and colleagues how to apply MV/MU.

This course is designed for any individual requiring an understanding of the importance of measurement uncertainty, the principles involved and how to develop simple uncertainty calculation models

• Laboratory and quality managers.
• Technical staffs.
• Users of laboratory services (clinicians and other clinical personnel).
• Researchers and scientists.
• Principle investigators.

Terms and definition associated with MV/MU

• Basic statistics
• Precision
• Accuracy
• Linearity
• Biological reference intervals
• Diagnostic sensitivity and specificity
• Describing what Measurement Uncertainty is
• Metrological traceability
• Types of Measurement Uncertainty
• Sources of uncertainty
• The principles for estimation of measurement uncertainty