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
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.
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 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! 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
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.
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.
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