What You Need To Know About CLIA Waived Tests

Drug testing has become necessary in light of the growing drug abuse problem especially in the workplace. In light of this, Congress formulated the Clinical Laboratory Improvement Amendments (CLIA).

All laboratories in the United States conduct testing on human specimens for the purpose of health assessment or diagnosis. Such tests are regulated based on the guidelines set forth by the CLIA. Read on and be informed about these waived tests.

What is the CLIA Law of 1988?

In 1988, the U.S. Congress established the Clinical Laboratory Improvement Amendments (CLIA). The law is designed to control and regulate the standards for laboratory tests of human samples. CLIA was put in place to ensure that laboratory test results are timely, accurate, and reliable.

Despite the law’s approval in 1988, it was only in 1992 when the final regulations were published via the Federal Register. According to the Centers for Medicare and Medicaid Services (CMS), the requirements are beyond the type of laboratory performing the test. Instead, it concentrated more on the complexity of the test to be performed.

CMS facilitates the operation of the CLIA program. There are three divisions within the agency that implements the program: the Center for Medicaid and State Operations, Survey and Certifications Group, and the Division of Laboratory Services. Funding for the CLIA program comes from fees collected from about 200,000 laboratories, mostly in the United States.

The CMS and the Centers for Disease Control and Prevention drafted the final CLIA Quality Systems Laboratory regulations that became effective in April 2003.

CLIA waived test kit

What Is A CLIA Waived Test?

The CLIA defines a CLIA-waived test as a laboratory procedure that is so simple and accurate that it is unlikely to product incorrect results.

However, even if they are waived, these laboratory tests still have the potential to have serious health impact if done incorrectly. For instance, the results can be used for adjusting dosages.

Likewise, any errors in the result can lead to unintended consequences. As such, it is important to ensure that the tests are done correctly. It should be performed by trained personnel and in an environment that adheres to regulations.

To be waived, a laboratory test must be proven that it is not harmful to the human body. It also becomes waived if the Food and Drug Administration (FDA) has approved its use at home. FDA is tasked with approving a manufacturer’s application for waived testing. If they determine that the tests pass the criteria, they will issue a certificate of waiver.

Examples of tests that can be waived under the CLIA include:

  1. Non-automated urinalysis using dipstick or tablet reagents
  2. Fecal occult blood
  3. Ovulation tests
  4. Urine pregnancy tests
  5. Erythrocyte sedimentation rate
  6. Spun microhematocrit
  7. Blood glucose monitoring using home use devices
  8. Saliva alcohol test
  9. Hemoglobin test using devices with self-contained features which provide results through direct measurement

Laboratories that conduct CLIA-waived tests need to renew their certification every couple of years and they should perform the tests in a controlled environment. CMS will not inspect these laboratories except when there are complaints.

FDA cleared CLIA

How Is A Laboratory Test Waived?

Under the CLIA stipulations, laboratory tests, assays, and examinations are scored based on their complexity level. A score of 1 means the test had the lowest level of complexity, while a score of 3 means it had a high level of complexity. A score of 2 means that the level of complexity is between that of score 1 and 3.

The scores of the test are based on the following criteria:

  • Level of knowledge
  • Preparation of reagents and materials
  • Characteristics of operational steps
  • Interpretation and judgment
  • Training and experience
  • Materials used for calibration, quality control, and proficiency testing
  • Test system troubleshooting and equipment maintenance

Based on CLIA guidelines, tests and test systems that comply with the risk, error, and complexity requirements are granted a certificate of waiver. In November 2007, the U.S. Congress amended waiver provisions making it clear that FDA-approved tests for home use are automatically CLIA-waived.

This was done despite the fact that many of them were performed against designed protocols. Half were done incorrectly resulting to medical errors leading to fatal consequences.

Although the CLIA requires waived test to be simple and have a low risk for erroneous results, it does not mean that they are completely free from error. Errors can happen during the testing process, especially when the instructions of the manufacturer were not completely followed. An error could also happen when the personnel conducting the test lacks familiarity with the testing system.

What is a Non-CLIA Waived Testing?

On the other hand, non-CLIA waived testing, as defined by the CDC, involve tests that have moderate or high level of complexity. Non-CLIA waived testing should be conducted in CLIA-certified laboratories, which need to be inspected and should comply with the standards set by the CLIA.

Benefits Of Using CLIA Waived Urine Testing Cups

Using CLIA waived urine testing cups in contrast with a non-waived one offers a wide range of benefits.

  • The fact that they have already met the standards set forth by CLIA, one can already count on their reliability. As such, there is no longer a need for patients and practitioners to doubt the effectiveness of using them for laboratory testing.
  • These cups have already been approved, and so you no longer need to check if the laboratory where they are being tested is already CLIA-certified.
  • CLIA waived drug tests are deemed accurate and so there is zero or minimal room for error. Therefore, the chances that there will be an error is relatively significant. Patients will therefore have peace of mind and assurance that there will be no false-positive results for the procedure being conducted.
  • CLIA waived urine testing cups also offer a wide range of flexibility. Patients can opt for a 12-panel or 10-panel testing cup. There is also an option to choose a 5-cup panel. The choice will boil down to the type of drug being tested.

Lena Butler

My name is Lena Butler. I live in San Diego, California. I work as a customer service representative for TestCountry.com. I attended the University of San Diego and majored in marketing. I enjoy spending time at home, working on my painting and playing with my two pet rabbits, Carl and Lenny, when I am not here sharing interesting posts :)

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