At a glance
United States lab facilities are regulated under Clinical Laboratory Improvement Amendments of 1988 (CLIA), including waived tests. These tests must be performed correctly to avoid errors and serious health impacts.
Background
All facilities in the United States performing laboratory testing on human specimens for health assessment are regulated under CLIA. This regulation covers testing for diagnosis, prevention, and treatment of disease.
Waived tests include test systems cleared by the FDA for home use and those approved for waiver under the CLIA criteria. While CLIA requires waived tests to be simple and low-risk, they are not completely error-proof. Errors can occur in testing if manufacturer's instructions are not followed or if personnel are unfamiliar with the test system.
Some waived tests have potential for serious health impacts if performed incorrectly. Waived test results, such as prothrombin time and glucose levels, adjust medication dosages for anticoagulant therapy and diabetes. In addition, erroneous results from diagnostic tests, such as those for human immunodeficiency virus (HIV) antibody, can have unintended consequences. To reduce errors, tests must be performed correctly by trained personnel in environments adhering to good laboratory practices.
CLIA Certificate of Waiver
You can enroll your laboratory or testing site in the CLIA program by completing an application. It is available on the CMS CLIA website or from your local State Agency.
Send your application to the address of the local State Agency for the State in which your testing site is located. Additionally, check with your State Agency for any other state-specific requirements.
If you do not have the contact information of your State Agency, access the CMS Contact Information for State Survey Agencies site to find the phone number and address.
For questions, please email CMS Lab Excellence at LabExcellence@cms.hhs.gov.
Educational materials
To Test or Not to Test? Booklet
This booklet outlines considerations and preparations for performing waived tests. It also assists those implementing or overseeing testing under a CLIA Certificate of Waiver. The booklet contains tips, reminders, and resources along with forms and examples for use in your testing site.
This booklet outlines recommended practices for physicians, nurses, medical assistants, pharmacists, and others testing patients under a CLIA Certificate of Waiver. The booklet contains tips, reminders, and resources along with forms and examples for use in your testing site.
This checklist highlights best practices for physicians, nurses, and others performing patient tests under a CLIA Certificate of Waiver. It can be used as a voluntary tool to help assure good testing practices and reliable, high quality test results.
Ready? Set? Test! Online Course
This course offers free continuing education credits. The goal of this course is to promote reliable, high-quality testing and enhance patient safety. This is done by explaining steps of the waived testing process. It also provides the learner with additional resources to assist on the job.
The target audience includes individuals who perform testing in waived testing sites throughout the United States. Examples include physician offices, nursing facilities, home health agencies, clinics, pharmacies and other non-laboratory sites. They include a variety of individuals, primarily those who do not have formal laboratory training.