Clinical and Laboratory Standards Institute guideline QMS12—Developing and Using Quality Indicators for Laboratory Improvement provides recommendations on developing meaningful quality indicators for single and multiple laboratory organizations. This guideline includes criteria for selecting quantitative and qualitative indicators. It also includes procedures for gathering data and using the information to present and interpret results, monitor performance over time, and communicate laboratory indicator performance to internal and external laboratory customers.

This guideline replaces the previous edition of the approved guideline, QMS12-A, published in 2010. Several changes were made in this edition, including the addition of: 

• Definitions for data, information, and knowledge, with laboratory examples of each 

• A flow chart for developing, evaluating, implementing, and monitoring a laboratory quality indicator 

• An updated form for constructing an effective quality indicator 

• An example of a completed quality indicator development form 
 

• Information about monitoring quality indicators across laboratories within the same health care system

This guideline describes how to develop and use quality indicators in the medical laboratory. These indicators include measures developed within a single laboratory for local use, as well as indicators developed or required by regulatory and accreditation organizations. This guideline also provides criteria for developing quantitative and qualitative indicators. In addition, it includes procedures for gathering data, presenting and interpreting results, monitoring performance over time, and comparing performance with that of other laboratories or national norms.

This guideline's main focus is quality indicators for preexamination, examination, and postexamination processes, because these are specifically required by regulatory and accreditation organizations. However, the process flow, concepts, and indicator development form presented in this guideline can also be used to create indicators to measure the effectiveness of the laboratory's QMS (ie, management) processes, if desired.

This guideline is intended for use by laboratory directors, managers, supervisors, and the quality manager as a means to ensure laboratories implement an effective approach to selecting, developing, interpreting, and using information derived from well-designed quality indicators.

Although laboratories can study these areas as a reflection of laboratory quality, this guideline does not cover monitoring of:

• Proficiency testing (PT) (see CLSI document QMS24)

• QC (see CLSI document EP23™)

• Personnel competence (see CLSI document QMS03)

• Customer satisfaction (see CLSI document QMS19)

This guideline is also integrated into and consistent with the other CLSI quality management documents that provide a complete approach to implementing a laboratory QMS.