CLSI QMS24
Using Proficiency Testing and Alternative Assessment to Improve Medical Laboratory Quality
This guideline walks labs through a reliable approach for a complete proficiency testing (PT) process while also providing assistance to laboratories in using PT as a quality improvement tool.
This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of May 2021.
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{{FormatPrice(nonMemberPrice)}} List PriceClinical and Laboratory Standards Institute guideline QMS24—Using Proficiency Testing and Alternative Assessment to Improve Medical Laboratory Quality provides laboratories with a detailed description of important activities in the proficiency testing (PT) process and includes suggestions for how to improve this process from a quality management perspective. It includes a suggested classification of unacceptable PT results and specific examples of investigations of unacceptable results.
This guideline replaces the second edition of GP27, published in 2007, and has been recoded as QMS24. Several changes were made in this edition, including:
- The terminology and definitions were updated and clarified.
- The scope of the guideline was expanded to include information published in CLSI document GP29, and to eliminate redundancy with that document.
- The entire guideline was reorganized and updated to be consistent with CLSI’s quality system essentials, with a focus on using a process workflow for the PT process.
- A process flow chart was added that outlines development, implementation, and monitoring of the PT process.
- Additional information on opportunities for improvement for laboratories in longitudinal review of successful PT events was included.
- Additional information to assist laboratories in using PT to assess and improve laboratory quality was included.
- Chapters were added to provide an in-depth discussion of PT in specialized areas of the laboratory, such as molecular and gynecological cytology.
The purpose of this guideline is to help medical laboratories use proficiency testing (PT) as a quality improvement tool. This guideline presents a systematic approach for designing the PT process as a component of the laboratory QMS.
QMS24 is intended for clinical laboratory managers and analysts in both the public and private sectors, and is applicable to any setting in which clinical laboratory testing is performed, from bedside testing to large multispecialty laboratories. This guideline applies to both qualitative and quantitative laboratory testing, including detection and quantification of blood and fluid measurands and blood and tissue typing. Some discussions apply only to examinations with quantitative results, whereas other discussions apply to examinations with qualitative results.
The processes described in this guideline can help laboratories design a PT process, monitor PT results, and investigate and respond to unacceptable PT results. Part of this response may include preparation of information for submission to regulatory or accreditation organizations. Laboratories are cautioned, however, that regulatory and accreditation organizations may have additional requirements not supported by the guidance in QMS24.
QMS24 also provides guidance for how to use PT as a tool to prevent problems through analysis of acceptable results, education of laboratory personnel, and monitoring of internal processes.
This guideline does not recommend specific corrective actions for specific root causes (see CLSI document QMS11).
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.
This document is available in electronic format only.
Clinical and Laboratory Standards Institute guideline QMS24—Using Proficiency Testing and Alternative Assessment to Improve Medical Laboratory Quality provides laboratories with a detailed description of important activities in the proficiency testing (PT) process and includes suggestions for how to improve this process from a quality management perspective. It includes a suggested classification of unacceptable PT results and specific examples of investigations of unacceptable results.
This guideline replaces the second edition of GP27, published in 2007, and has been recoded as QMS24. Several changes were made in this edition, including:
- The terminology and definitions were updated and clarified.
- The scope of the guideline was expanded to include information published in CLSI document GP29, and to eliminate redundancy with that document.
- The entire guideline was reorganized and updated to be consistent with CLSI’s quality system essentials, with a focus on using a process workflow for the PT process.
- A process flow chart was added that outlines development, implementation, and monitoring of the PT process.
- Additional information on opportunities for improvement for laboratories in longitudinal review of successful PT events was included.
- Additional information to assist laboratories in using PT to assess and improve laboratory quality was included.
- Chapters were added to provide an in-depth discussion of PT in specialized areas of the laboratory, such as molecular and gynecological cytology.
The purpose of this guideline is to help medical laboratories use proficiency testing (PT) as a quality improvement tool. This guideline presents a systematic approach for designing the PT process as a component of the laboratory QMS.
QMS24 is intended for clinical laboratory managers and analysts in both the public and private sectors, and is applicable to any setting in which clinical laboratory testing is performed, from bedside testing to large multispecialty laboratories. This guideline applies to both qualitative and quantitative laboratory testing, including detection and quantification of blood and fluid measurands and blood and tissue typing. Some discussions apply only to examinations with quantitative results, whereas other discussions apply to examinations with qualitative results.
The processes described in this guideline can help laboratories design a PT process, monitor PT results, and investigate and respond to unacceptable PT results. Part of this response may include preparation of information for submission to regulatory or accreditation organizations. Laboratories are cautioned, however, that regulatory and accreditation organizations may have additional requirements not supported by the guidance in QMS24.
QMS24 also provides guidance for how to use PT as a tool to prevent problems through analysis of acceptable results, education of laboratory personnel, and monitoring of internal processes.
This guideline does not recommend specific corrective actions for specific root causes (see CLSI document QMS11).
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.
This document is available in electronic format only.