Direct access testing in the clinical laboratory: should laboratories offer testing services directly to the consumer?

This article outlines the author's views on the many issues to consider if a laboratory plans to initiate a program to offer clinical laboratory testing directly to the public. Direct access testing and why is it important are discussed in detail. The regulatory issues are outlined with some alternatives for laboratories in states with restrictive regulations. To illustrate many of the operational issues to consider, the author describes the Personal Diagnostic Center (PDC) in Kansas City. Finally, some of the key business issues are mentioned, including several approaches to promote this type of testing program.