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