Waived Tests

All facilities in the United States that perform laboratory testing on human specimens for health assessment or the diagnosis, prevention, or treatment of disease are regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Waived tests include test systems cleared by the FDA for home use and those tests approved for waiver under the CLIA criteria. Although CLIA requires that waived tests must be simple and have a low risk for erroneous results, this does not mean that waived tests are completely error-proof. Errors can occur anywhere in the testing process, particularly when the manufacturer’s instructions are not followed and when testing personnel are not familiar with all aspects of the test system.

Some waived tests have potential for serious health impacts if performed incorrectly. For example, results from waived tests can be used to adjust medication dosages, such as prothrombin time testing in patients undergoing anticoagulant therapy and glucose monitoring in diabetics. In addition, erroneous results from diagnostic tests, such as those for human immunodeficiency virus (HIV) antibody, can have unintended consequences. To decrease the risk of erroneous results, the test needs to be performed correctly, by trained personnel and in an environment where good laboratory practices are followed.

You can enroll your laboratory or testing site in the CLIA program by completing an application (Form CMS-116) available on the CMS CLIA website or from your local State Agency. Send your completed application to the address of the local State Agency for the State in which your laboratory or testing site is located. Additionally, check with your State Agency for any other state-specific requirements. If you do not have online access and do not have information about your State Agency, you may contact the CLIA program at 410-786-3531 for the address and phone number of your State Agency. For more information, please see the How to Obtain a CLIA Certificate of Waiver brochure. For questions, please email CMS LAB Excellence at LabExcellence@cms.hhs.gov.

MMWR R&R Good Laboratory Practices for Waived Testing Sites

In 2005, CDC, Division of Laboratory Science and Standards (DLSS) (previously Division of Laboratory Systems), published the MMWR Recommendations and Reports on “Good Laboratory Practices for Waived Testing Sites.” The recommendations in this report are intended to be a resource for physicians, nurses and others who perform waived tests in sites holding a CLIA Certificate of Waiver. The recommendations were published to promote quality testing, reduce testing errors, and enhance patient safety.

To Test or Not to Test? Booklet [PDF – 6 MB]

Spanish Version This booklet describes considerations and preparations needed prior to performing waived testing and may assist those who want to implement and oversee waived testing or offer a new test under a CLIA Certificate of Waiver. The booklet contains tips, reminders, and resources along with forms and examples for use in your testing site.

Ready? Set? Test! Booklet [PDF – 8 MB]

This booklet describes recommended practices for physicians, nurses, medical assistants, pharmacists, and others who perform patient 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.

Self Assessment Checklist [PDF – 16 KB]

This self-assessment checklist emphasizes recommended practices for physicians, nurses, medical assistants, pharmacists, and others who perform patient testing under a Clinical Laboratory Improvement Amendments (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

The goal of this course is to promote reliable, high quality testing and enhance patient safety by explaining steps of the waived testing process and to provide the learner with additional resources to assist on the job. The target audience includes individuals who perform testing in waived testing sites (physician offices, nursing facilities, home health agencies, clinics, pharmacies and other non-laboratory sites) throughout the United States. They include a variety of individuals, primarily those who do not have formal laboratory training. This course offers free continuing education credits.

For questions, comments, or to request hardcopies of our products, please e-mail: WaivedTesting@cdc.gov