When you get some lab tests done, either for yourself or for your home, you may have encountered laboratories or facilities that declare themselves to offer CLIA waived tests. You might even encounter a certificate that says" hanging on the wall". Yet the question will still remain on: What are CLIA waived tests?
What is The CLIA 1988 Law?
CLIA definitely stands for Clinical Laboratory Improvement Amendments. In the year 1988, this was a set of regulations passed by the United States government. On any specimen or sample derived from the human body, its main purpose is to set and control the standards for clinical laboratory testing.
The CLIA's main goal is to make sure that the test results done in a clinical laboratory are timely, accurate and reliable. For the purposes of diagnosing and treating a disease, a clinical laboratory as defined under the CLIA law is a place where tests on specimens taken from the human body are conducted .
The government agencies that have jurisdiction when it comes to CLIA 1988 are: the Centers for Medicare and Medicaid Services or CMS. When it comes to CLIA, CMS performs supervisory and regulating tasks and that may include: granting certificates for this testing in approved laboratories.
What is meant with CLIA Waived Tests
Some kinds of lab tests are considered to be CLIA waived. If a test is CLIA waived, it is impossible to produce incorrect results in conducting the test because, this means the test itself is so simple and accurate.
The test is CLIA waived, if it is proven that it does not do any harm to the human body. Automatically, the test will be CLIA waived, if the Food and Drug Authority has approved its use at home.
Here below are the tests that are considered CLIA waived:
1.Blood glucose monitoring utilizing devices specifically for home use , 2.Spun microhematocrit ,3.Non-automated urinalysis using dipstick or tablet reagents, 4.Ovulation tests , 5.Urine pregnancy tests , 6.Fecal occult blood , 7.Hemoglobin-copper sulfate , 8.Erythrocyte sedimentation rate , 9.Hemoglobin testing done through devices with self-contained features and which give readout results via direct measurement
The laboratories that conduct tests have to do the following: first, renew their certification every two years and second, they have to conduct their tests in a controlled environment. Most of the time, the CMS does not conduct inspections of laboratories that offer CLIA waived testing yet, in cases of complaint. They certainly have to do so.
If the instructions provided by their manufacturer are closely followed, you are assured that the test will be safe. If there is a need for you to send samples to a lab for a procedure or if you need to use a home testing kit, and it falls under the list of this tests, then there should be no harm coming out of it. For instance where you have complaints, and you can free to contact the CMS or the FDA.
What is The CLIA 1988 Law?
CLIA definitely stands for Clinical Laboratory Improvement Amendments. In the year 1988, this was a set of regulations passed by the United States government. On any specimen or sample derived from the human body, its main purpose is to set and control the standards for clinical laboratory testing.
The CLIA's main goal is to make sure that the test results done in a clinical laboratory are timely, accurate and reliable. For the purposes of diagnosing and treating a disease, a clinical laboratory as defined under the CLIA law is a place where tests on specimens taken from the human body are conducted .
The government agencies that have jurisdiction when it comes to CLIA 1988 are: the Centers for Medicare and Medicaid Services or CMS. When it comes to CLIA, CMS performs supervisory and regulating tasks and that may include: granting certificates for this testing in approved laboratories.
What is meant with CLIA Waived Tests
Some kinds of lab tests are considered to be CLIA waived. If a test is CLIA waived, it is impossible to produce incorrect results in conducting the test because, this means the test itself is so simple and accurate.
The test is CLIA waived, if it is proven that it does not do any harm to the human body. Automatically, the test will be CLIA waived, if the Food and Drug Authority has approved its use at home.
Here below are the tests that are considered CLIA waived:
1.Blood glucose monitoring utilizing devices specifically for home use , 2.Spun microhematocrit ,3.Non-automated urinalysis using dipstick or tablet reagents, 4.Ovulation tests , 5.Urine pregnancy tests , 6.Fecal occult blood , 7.Hemoglobin-copper sulfate , 8.Erythrocyte sedimentation rate , 9.Hemoglobin testing done through devices with self-contained features and which give readout results via direct measurement
The laboratories that conduct tests have to do the following: first, renew their certification every two years and second, they have to conduct their tests in a controlled environment. Most of the time, the CMS does not conduct inspections of laboratories that offer CLIA waived testing yet, in cases of complaint. They certainly have to do so.
If the instructions provided by their manufacturer are closely followed, you are assured that the test will be safe. If there is a need for you to send samples to a lab for a procedure or if you need to use a home testing kit, and it falls under the list of this tests, then there should be no harm coming out of it. For instance where you have complaints, and you can free to contact the CMS or the FDA.
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