scope:

This guideline addresses the purpose of statistical quality control for quantitative measurement procedures; describes an approach for planning quality control for a particular measurement procedure; provides a definition of an analytical run; addresses the use of quality control material and quality control data, including the use of the data in quality assurance and interpretation; and provides detailed examples that demonstrate a practical QC planning process for clinical laboratories. The recommendations given are applicable to quantitative laboratory tests in all fields of laboratory medicine where external stable control materials can be measured like patient specimens. The document does not contain step-by-step procedures for establishing and maintaining a statistical quality control program, or for other aspects of quality control, such as instrument function checks or the use of patient values for quality control purposes.

This guideline applies to a broad spectrum of clinical laboratories, from the low test volume to the high test volume. The analytical performance and quality control required for a measurement procedure must satisfy the medical applications of the particular test, which relate to inherent clinical aspects of the laboratory's patient population regardless of the laboratory's size, location, or complexity. Particularly in the low-volume environment, the decision to implement a given measurement procedure should carefully take into account (in addition to elements such as cost, service requirements, training requirements, and required turnaround time) the complexity and performance characteristics of the procedure. Measurement procedures are selected to meet medical needs. Once implemented, however, quality control is needed to ensure that the test results will continue to satisfy the medical needs.