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Waived Tests


Background

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.

Educational Materials

mmr

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.

ToTestOrNotToTest

To Test or Not to Test? Booklet   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.

ReadySetTestPoster

Ready? Set? Test! Poster, [HTML Version]  Spanish Version

This poster can readily be displayed in a testing area to remind testers of 10 important practices to follow for accurate and reliable testing. A postcard sized version of the poster is also available

ReadySetTestBooklet

Ready? Set? Test! Booklet  Spanish Version

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.

ReadySetTestOnlineCourse

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

Useful Websites

 
Contact Us:
  • Centers for Disease Control and Prevention,
    Division of Laboratory Programs, Standards, and Services
    1600 Clifton Road
    Mailstop F-11
    Atlanta, GA 30333, USA
  • CLIA Direct Line:
    404-498-2290
  • CLIA@cdc.gov
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