The Clinical and Laboratory Standards Institute (CLSI) recently published Quality Practices in Noninstrumented Point-of-Care Testing: An Instructional Manual and Resources for Health Care Workers; Approved Guideline (POCT08-A).

This instructional guideline delivers laboratory science concepts and activities with the goal of increasing knowledge and quality of laboratory testing for testing personnel with little or no laboratory background.

"POCT08-A is designed to make the basic principles of good laboratory practice accessible to all the diverse personnel performing noninstrumented tests at the point of care. It contains discussion and examples of basic practices that support accurate testing, and an extensive set of forms and protocols to use as resources for those managing such testing," said Sheldon Campbell, MD, PhD, FCAP, Yale University School of Medicine, and chairholder of the subcommittee that created the document.

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 to document performance

This document is an atypical document for CLSI because it targets health care workers who administer point-of-care testing (POCT), but have little or no specific training in laboratory practices. These noninstrumented tests are simple devices such as urine dipsticks, fecal occult blood test cards, and rapid flu tests that are read by eye, without a reader or other test instrument.

The simplicity of POCT can be deceptive. Complicated technology is required for a simple test, and even simple tests are used to make important medical decisions. Noninstrumented technologies may lack the robust fail-check mechanisms of tests performed by automated instruments. This makes the quality and accuracy of results more dependent on the operator of the test and on manual quality checks.

"In addition to policies and procedures, an understanding of the underlying principles of good laboratory practice will help people performing testing to do it right. The accessible descriptions and examples in POCT08-A are designed not only to provide knowledge, but also to build skills, understanding, and attitudes conducive to good laboratory practice," said Dr. Campbell.

POCT08-A is intended to help facilities and individual workers provide accurate, reliable, clinically useful POCT services to improve the speed, accessibility, and quality of patient care.

This document will be helpful to heath care workers who perform noninstrumented POCT, such as medical technologists and other laboratory professionals, nurses and medical personnel, nonmedically trained workers, and manufacturers and distributors of noninstrumented point-of-care tests. Sites and disciplines employing noninstrumented POCT include, but are not limited to, physician offices, schools, sports organizations, community service and outreach programs, home care, and telemedicine.

Source: CLSI