Standard Document
First Edition
Point-of-Care Testing

CLSI POCT07

Quality Management: Approaches to Reducing Errors at the Point of Care

This guidance introduces testing personnel the core infrastructure for a standardized error tracking system. It is designed to reduce risk and enhance quality of point-of-care testing, while also collecting standardized date for benchmarking purposes.

This document is exclusively available in an electronic format for your convenience and accessibility.

This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as ofJanuary 2018. 

October 07, 2010
Lou Ann Wyer, MS, MT(ASCP)

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Abstract

This document presents the core infrastructure for a risk management and standardized error tracking system for reducing risk at the point of care, as well as for benchmarking purposes. Clinical and Laboratory Standards Institute document POCT07-A—Quality Management: Approaches to Reducing Errors at the Point of Care; Approved Guideline proposes a set of indicators for each analytical process for incorporation into a point-of-care quality program. It also presents the user with predefined common causes of error and respective error prevention mechanisms for a more standardized reporting mechanism. POCT07-A encourages institutions to define their own additional indicators based on industry risk management procedures presented in this document. An error tracking system can also offer possibilities for benchmarking and improvement of point-of-care processes.

Scope

This document provides a basic framework or infrastructure for a standardized risk management system. Error indicators for each analytical phase are suggested for incorporation into a quality management program. This guideline serves as a complementary tool to laboratory quality management procedures. 

This guideline is intended for use by laboratory directors, managers, supervisors, quality managers, point-of-care coordinators (POCCs), and other testing personnel responsible for implementing the policies, processes, procedures, activities, and records that support the quality management activities described herein. Although it is understood that point-of-care testing (POCT) is performed in a variety of settings, the structure and contents of this document focus more on hospital-based programs. The information in this document can be applied to all POCT instruments and kits. However, some parameters may be relevant only to POCT in hospital or large institutional settings. 

The goal of this guideline is to improve the performance of POCT by developing different indicators that are applicable to all aspects of preexamination, examination, and postexamination phases of the testing. This document highlights the critical components of a POCT quality management program, as well as defines the critical role that central laboratories should play in the coordination of POCT quality activities.

Product Details
POCT07AE
1-56238-734-0
68
Additional Details

This document is available in electronic format only.

Authors
Lou Ann Wyer, MS, MT(ASCP)
Valerie L. Ng, PhD, MD
Diane Burford, MT(ASCP) QPOCTE
Wadid Sadek, PhD
Ronda D. Elliott, ASQ, CQM
Halcyon St. Hill, EdD, MS, MT(ASCP)
Cheryl Hackett, MT(ASCP)
Megan E. Sawchuk, MT(ASCP)
Abdel-Baset Halim, PharmD, PhD, DABCC
Kathy Scruggs, MT(ASCP)
Ellis Jacobs, PhD, DABCC, FACB
Sally Skrlin, MT(ASCP)
Kenneth C. Jensen, PhD
Monica Thomas, MPA, MT(ASCP)
Abstract

This document presents the core infrastructure for a risk management and standardized error tracking system for reducing risk at the point of care, as well as for benchmarking purposes. Clinical and Laboratory Standards Institute document POCT07-A—Quality Management: Approaches to Reducing Errors at the Point of Care; Approved Guideline proposes a set of indicators for each analytical process for incorporation into a point-of-care quality program. It also presents the user with predefined common causes of error and respective error prevention mechanisms for a more standardized reporting mechanism. POCT07-A encourages institutions to define their own additional indicators based on industry risk management procedures presented in this document. An error tracking system can also offer possibilities for benchmarking and improvement of point-of-care processes.

Scope

This document provides a basic framework or infrastructure for a standardized risk management system. Error indicators for each analytical phase are suggested for incorporation into a quality management program. This guideline serves as a complementary tool to laboratory quality management procedures. 

This guideline is intended for use by laboratory directors, managers, supervisors, quality managers, point-of-care coordinators (POCCs), and other testing personnel responsible for implementing the policies, processes, procedures, activities, and records that support the quality management activities described herein. Although it is understood that point-of-care testing (POCT) is performed in a variety of settings, the structure and contents of this document focus more on hospital-based programs. The information in this document can be applied to all POCT instruments and kits. However, some parameters may be relevant only to POCT in hospital or large institutional settings. 

The goal of this guideline is to improve the performance of POCT by developing different indicators that are applicable to all aspects of preexamination, examination, and postexamination phases of the testing. This document highlights the critical components of a POCT quality management program, as well as defines the critical role that central laboratories should play in the coordination of POCT quality activities.

Additional Details

This document is available in electronic format only.

Authors
Lou Ann Wyer, MS, MT(ASCP)
Valerie L. Ng, PhD, MD
Diane Burford, MT(ASCP) QPOCTE
Wadid Sadek, PhD
Ronda D. Elliott, ASQ, CQM
Halcyon St. Hill, EdD, MS, MT(ASCP)
Cheryl Hackett, MT(ASCP)
Megan E. Sawchuk, MT(ASCP)
Abdel-Baset Halim, PharmD, PhD, DABCC
Kathy Scruggs, MT(ASCP)
Ellis Jacobs, PhD, DABCC, FACB
Sally Skrlin, MT(ASCP)
Kenneth C. Jensen, PhD
Monica Thomas, MPA, MT(ASCP)