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Posted by admin | Posted in Spas & More | Posted on 16-04-2010

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Test Kit Reagent

What you should know about testing CLIA Waived

When you need to get laboratory tests done, whether you or for your home, you may experience laboratories or facilities that report to provide CLIA waived tests. They would probably also a certificate stating that hanging on a wall. But perhaps the question you might have would be: What are CLIA waived tests?

CLIA Act of 1988

CLIA stands for Clinical Laboratory Improvement Amendments. It was a set of regulations adopted by the Government of the United States in 1988. Its purpose was define and monitor standards for clinical laboratory tests on a specimen or sample from the human body.

The objective of CLIA is to ensure that the results of tests conducted in a clinical laboratory in a timely, accurate and reliable. From a clinical laboratory as defined in CLIA Law is a place where the tests on samples taken from the human body are carried out for diagnosis and treatment of disease.

The government agency that has jurisdiction CLIA 1988 the Centers for Medicare and Medicaid Services or CMS. The CMS performs the tasks of monitoring and regulating when it comes to CLIA, including the granting of licenses for CLIA waived tests in accredited laboratories.

What is CLIA waived tests Average?

There are certain types of laboratory tests that are considered as CLIA waived. When a test is CLIA waived, it means that the test itself is simple and precise, in itself, it is impossible to produce incorrect results for their achievement.

A test may be waived if it is proved that CLIA does not harm the body human. In addition, a test is automatically CLIA waived if the Food and Drug Administration approved its use at home.

The specific tests that are deemed waived CLIA are:

1. urinalysis non-automated using the dipstick or tablet reagent

2. ovulation tests

3. urine pregnancy tests

4. occult blood in stool

5. copper sulphate-Hemoglobin

6. Sedimentation rate

7. surveillance glucose using devices specifically for home use

8. Spun microhematocrit

9. hemoglobin test done through devices with features that provide independent and direct reading results through measurements

The laboratories are CLIA waived tests renew their certification every two years and they must conduct their tests in a controlled environment. The CMS does not conduct inspections of laboratories that offer CLIA waived tested, except in cases of complaints.

In other words, CLIA waived tests are safe as long as the instructions provided by their manufacturer are followed closely. If you need to send samples to a laboratory for a procedure that falls under the list of CLIA waived to testing or if you need to use a home testing kit, no harm should come out of it. But if that happens, you can always contact CMS or the FDA to file a complaint.

About the Author

This Article is written by Lena Butler, the author of Home Testing Kits a longer version of this article is located at What You Need to Know About CLIA Waived Tests, and resources from other home health and wellness testing articles are used such as CLIA Waived Testing.


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