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