Standard Document
First Edition
Point-of-Care Testing

CLSI POCT08

Quality Practices in Noninstrumented Point-of-Care Testing: An Instructional Manual and Resources for Health Care Workers

CLSI POCT08 simplifies laboratory science concepts and activities for testing personnel who don't have a laboratory background. The guide aims to enhance their knowledge and ensure consistent quality in point-of-care testing.

This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of January 2017. 

December 03, 2010
Sheldon M. Campbell, MD, PhD, FCAP

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Abstract

The goal of Clinical and Laboratory Standards Institute document POCT08-A—Quality Practices in Noninstrumented Point-of-Care Testing: An Instructional Manual and Resources for Health Care Workers; Approved Guideline is to improve the quality of noninstrumented point-of-care testing by generating a deep understanding of the testing process while eliciting commitment of testing personnel to quality and patient care. The guideline uses a simplified instructional approach to present scientific concepts, highlight the areas where quality can be compromised, and provide methods to avoid errors.

Scope

This document is designed to provide education in basic concepts of good laboratory practice to a wide audience; to provide tools, protocols, and examples to illustrate and assist in the implementation of good laboratory practices; and to provide templates and other resources to make it easier to build a high-quality point-of-care testing (POCT) program. 

The intended audience includes: 

• Medical technologists and other laboratory professionals engaged in noninstrumented POCT 

• Nurses and other medical personnel without laboratory training or specialization who perform such testing 

• Nonmedically trained workers performing such testing 

• Laboratory professionals and others engaged in oversight or consultation 

• Manufacturers and distributors of noninstrumented point-of-care tests 

Organizations that may engage in noninstrumented POCT and that might use this guideline include, but are not limited to: 

• Physician office and group practices 

• Hospitals and other acute-care facilities 

• Long-term care facilities 

• Home care organizations 

• Outreach and community organizations providing testing 

• Other settings where simple laboratory tests may improve disease detection or management 

Aspects of good laboratory practice addressed include: 

• Roles and responsibilities of the people involved in the testing system 

• Selecting, learning, proving, and implementing new tests 

• Avoiding errors before, during, and after testing 

• Building systems and procedures to maintain test quality 

• Recordkeeping to limit risk and document performance

Product Details
POCT08AE
1-56238-737-5
124
Additional Details

This document is available in electronic format only.

Authors
Sheldon M. Campbell, MD, PhD, FCAP
Sharon E. Granade, MPH, MT(ASCP)
Jeanniline Koehler, MT(ASCP)SBB CLS(NCA)
Peggy Mann, MS, MT(ASCP)
Valerie L. Ng, PhD, MD
Sharon K. Norman, MBA, MT(ASCP)
Joan E. Paulson, MLS(ASCP)CM
Gregory P. Payne, RAC
Halcyon St. Hill, EdD, MS, MT(ASCP)
Kathy Scruggs, MT(ASCP)
Patricia White, BS, MT(ASCP)
Lou Ann Wyer, MS, MT(ASCP)
Supporting Resources
CLSI POCT08QG1
Corrective Action Quick Guide
Companion
Point-of-Care Testing
Free
CLSI POCT08QG2
Quality Control Troubleshooting Flow Chart
Companion
Point-of-Care Testing
Free
CLSI POCT08QG3
Quality Control Log Sheet Quick Guide
Companion
Point-of-Care Testing
Free
Abstract

The goal of Clinical and Laboratory Standards Institute document POCT08-A—Quality Practices in Noninstrumented Point-of-Care Testing: An Instructional Manual and Resources for Health Care Workers; Approved Guideline is to improve the quality of noninstrumented point-of-care testing by generating a deep understanding of the testing process while eliciting commitment of testing personnel to quality and patient care. The guideline uses a simplified instructional approach to present scientific concepts, highlight the areas where quality can be compromised, and provide methods to avoid errors.

Scope

This document is designed to provide education in basic concepts of good laboratory practice to a wide audience; to provide tools, protocols, and examples to illustrate and assist in the implementation of good laboratory practices; and to provide templates and other resources to make it easier to build a high-quality point-of-care testing (POCT) program. 

The intended audience includes: 

• Medical technologists and other laboratory professionals engaged in noninstrumented POCT 

• Nurses and other medical personnel without laboratory training or specialization who perform such testing 

• Nonmedically trained workers performing such testing 

• Laboratory professionals and others engaged in oversight or consultation 

• Manufacturers and distributors of noninstrumented point-of-care tests 

Organizations that may engage in noninstrumented POCT and that might use this guideline include, but are not limited to: 

• Physician office and group practices 

• Hospitals and other acute-care facilities 

• Long-term care facilities 

• Home care organizations 

• Outreach and community organizations providing testing 

• Other settings where simple laboratory tests may improve disease detection or management 

Aspects of good laboratory practice addressed include: 

• Roles and responsibilities of the people involved in the testing system 

• Selecting, learning, proving, and implementing new tests 

• Avoiding errors before, during, and after testing 

• Building systems and procedures to maintain test quality 

• Recordkeeping to limit risk and document performance

Additional Details

This document is available in electronic format only.

Authors
Sheldon M. Campbell, MD, PhD, FCAP
Sharon E. Granade, MPH, MT(ASCP)
Jeanniline Koehler, MT(ASCP)SBB CLS(NCA)
Peggy Mann, MS, MT(ASCP)
Valerie L. Ng, PhD, MD
Sharon K. Norman, MBA, MT(ASCP)
Joan E. Paulson, MLS(ASCP)CM
Gregory P. Payne, RAC
Halcyon St. Hill, EdD, MS, MT(ASCP)
Kathy Scruggs, MT(ASCP)
Patricia White, BS, MT(ASCP)
Lou Ann Wyer, MS, MT(ASCP)
Supporting Resources
CLSI POCT08QG1
Corrective Action Quick Guide
Companion
Point-of-Care Testing
Free
CLSI POCT08QG2
Quality Control Troubleshooting Flow Chart
Companion
Point-of-Care Testing
Free
CLSI POCT08QG3
Quality Control Log Sheet Quick Guide
Companion
Point-of-Care Testing
Free