Regulations: The Key Players
The key participants in the quest for laboratory quality have been the federal and state governments and the laboratory professional community. Very briefly, their roles are as follows:
- Federal Government - All laboratories that perform tests on "specimens derived from humans for the purpose of providing information for the diagnosis, prevention, and treatment of disease" fall under the Clinical Laboratory Improvement Amendments (CLIA). This means that if your doctor wants to run a blood test or urinalysis, or asks you for a stool or sputum sample, then CLIA will influence how these samples are handled and how the tests are performed.
Passed by Congress in 1988, the CLIA amendments were adopted to ensure the accuracy, reliability, and timeliness of patient test results. CLIA covers testing in all U.S. states, and every clinical laboratory in the country must obtain a certificate that defines the complexity of tests that the particular laboratory can perform.
- State Government - Several states have additional requirements that are equal to or more stringent than those outlined in the CLIA regulations. In these cases, the state, not the federal government, assumes primary responsibility for oversight of laboratory practices. This situation can occur only after the Centers for Medicare and Medicaid Services (CMS) have "deemed" the state requirements to be equal to or more stringent than the CLIA requirements.
- Laboratory Professional Organizations - The most visible line of defense for accurate results is federal regulation, but the foundation for this regulatory system is the voluntary self-policing systems developed by laboratory professionals and their organizations.
Two professional organizations, the College of American Pathologists (CAP) and The Joint Commission, had stringent, voluntary laboratory accreditation programs many years before the government required it. Today, both organizations continue to offer highly respected laboratory accreditation programs. Other organizations, such as the Clinical Laboratory Standards Institute (CLSI), a globally recognized, standards-developing organization, are involved in improving medical testing through the development and dissemination of standards, guidelines, and best practices.