Purpose
In 2005, CDC, 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 Clinical Laboratory
Improvement Amendments of 1988 (CLIA) Certificate of Waiver. The recommendations were published to promote
quality testing, reduce testing errors, and enhance patient safety.
To increase awareness, and to encourage the use of good laboratory practices, DLS is developing tools based
on the recommendations that waived sites can use for quick reference. One tool is a poster (below), listing
10 basic recommendations for good laboratory practices. Another tool, under development, is a brochure that
explains the recommendations in a simple-to-understand format.
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 CLIA (1). Waived tests include test
systems cleared by 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.
Tools for Using Waived Tests
- Good Laboratory Practices Poster - 'Ready, Set, Test!' is a printable poster that highlights good testing practices for
those who perform waived tests in laboratories operating under a CLIA Certificate of Waiver. Alternate HTML version.
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Other materials being developed by CDC and CMS will be posted in the future.
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Useful Websites:
References
(1) Clinical Laboratory Improvement Amendments of 1988, 42 U.S.C. 263a PL100-578 (1988).