College of American Pathologists

CLIA Waived Tests and Test Categories

It is the position of the College of American Pathologists that all clinical laboratory testing used for the diagnosis, prevention, treatment and assessment of human disease should be subject to quality control and proficiency testing.

It is the CAP’s belief that no test is so simple and straightforward to perform that erroneous results cannot occur and that no incorrect test result is “risk free” or inconsequential with regard to potential harm.

The fact that the United States Department of Health and Human Services has designated certain laboratory tests as “exempt” from the requirements of the CLIA regulations conflicts with the fundamental principle that documented quality control activities, participation in proficiency testing where available, or some alternative means of external monitoring are in the best interests of patient care and safety. Such participation should not adversely affect patient access to laboratory testing.

Revision History

Approved June 1990
Reaffirmed May 1993
Reaffirmed May 1996
Reaffirmed May 1999
Revised February 2001
Reaffirmed October 2005
Reaffirmed April 2012