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The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations include federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease.
Is Washington State exempt from CLIA?
In October 1993, Washington became the first state to have its clinical laboratory licensure program judged by the Federal Health and Human Services Centers for Medicare and Medicaid Services (CMS) as equivalent to CLIA and was granted an exemption.
What is a certificate of waiver test?
A Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver is a certification that allows a facility, primarily laboratories, to legally examine a person through waived tests in order to assess health, diagnose, and determine treatment.
What are examples of CLIA waived chemistry test?
The following are examples of CLIA-waived specimens: Glucose testing may be run with the whole blood from a capillary puncture or venous blood collected in a gray-topped tube. The gray tube contains an antiglycosylating additive that prevents the glucose from being metabolized by RBCs.
Do I need a CLIA waiver Washington State?
Washington state is one of a few states that regulate their own certificates, and issues certificates. Pharmacies in Washington therefore only need to apply for a CLIA Waiver in Washington, and do not need to apply for a waiver at the federal level with CMS.
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What is waived testing? By the CLIA law, waived tests are those tests that are determined by CDC or FDA to be so simple that there is little risk of error. Some testing methods for glucose and cholesterol are waived along with pregnancy tests, fecal occult blood tests, some urine tests, etc.
Who is exempt from CLIA?
CLIA-exempt formally refers to a laboratory (not a test system) and means a laboratory that has been licensed or approved by a state where CMS has determined that the state has enacted laws relating to laboratory requirements that are equal to or more stringent than CLIA requirements, and the State licensure program
What are examples of waived tests?
As defined by CLIA, waived tests are simple laboratory examinations and procedures that have an indocHub risk of an erroneous result. Examples of waived tests include: dipstick urinalysis, fecal occult blood, urine pregnancy tests, and blood glucose monitoring.
What is the difference between waived and non waived testing?
Waived tests are simple tests with a low risk for an incorrect result. Nonwaived tests, also called Moderately Complex tests, are those tests that require a number of criteria to be met prior to the operator running the tests.
Which of the following is a CLIA waived test?
As defined by CLIA, waived tests are simple laboratory examinations and procedures that have an indocHub risk of an erroneous result. Examples of waived tests include: dipstick urinalysis, fecal occult blood, urine pregnancy tests, and blood glucose monitoring.
Related links
Certificate of Waiver Medical Test Site (MTS) Application Packet
When your application for a Medical Test Site is received by the Department of Health, you will be notified in writing of any outstanding documentation needed
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