CLIA Waived Products

In 1988 Congress passed the Clinical Laboratory Improvement Amendments, which are known as CLIA. CLIA guidelines are important laws defining quality standards for all laboratory scientific testing, ensuring the precision, consistency, and timeliness of patient test results regardless of where the test was performed.

All facilities in the United States performing laboratory testing on human specimens for health assessment are regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). CLIA Waived tests include test systems cleared by the Food & Drug Administration (FDA) for home use and those tests approved for a waiver under the CLIA criteria. Although CLIA requires that waived tests be simple and have a low risk for erroneous results, this does not mean that waived tests are entirely error-proof. Errors can occur anywhere in the testing process, particularly when the manufacturer's directions are not followed and when testing personnel is not familiar with all aspects of the test system.

Each laboratory and the home test has its own specific set of requirements. Certain tests can be complex and involve specialized or more advanced equipment; if they meet certain conditions, they can be waived from all regulatory processes. Simply put, these tests are cleared by the Food & Drug Administration and can be conducted in the privacy of the donor's home and may also be referred to as a version of Point of Care (POC) tests. The vast majority of these tests are simplistic, using only essential equipment. Therefore, inaccuracies or user errors are nearly impossible. Such tests are referred to as a CLIA waived. CLIA waived tests can also be billed to insurance companies.

Instant Tests and Positives

Instant drug tests are user-friendly and economical. On-Site Test Kits are easy to use, produce quick results, and are less expensive than conventional drug testing. IDrugScreen offers these types of testing kits for non-Federal use ONLY. You can order these kits online, by fax, or by calling us toll-free at 1-800-452-0030. Common types of Instant Drug Tests include:

• Dip Card Tests: On-site test kit is simple to use, and the results are easily interpreted. The donor voids into the cup and gives the specimen to a collector. The collector inserts the test card into the specimen, removes it from the specimen, and places it on a flat surface for processing. The result is ready to read within 5 minutes.
• Cups & Split Key Tests: The Integrated Cups providing a quick and easy testing system. There is no dip, no tip, and no drip. It's the one-step on-site test kit.
• Oral Fluid Devices: These on-site test kits are an excellent choice for collectors or corporations wishing to conduct drug testing without urine collection. The donor moistens the test's absorbent pad and swabs their mouth in a specific fashion. Results are available in minutes and visible in the result window.

When an instant drug test results in a positive outcome, additional steps are necessary to verify the preliminary or initial findings. The specimen is placed in the appropriate carrying vials, packaged along with the chain of custody form, and sent to the laboratory. Subsequently, the specimen undergoes confirmation testing to confirm the proper outcome. Once the laboratory confirms the exact findings, a complete laboratory analysis report is typically sent to the Medical Review Office. The MRO will seek to find a valid medical explanation and conclude by reporting the final report to the requesting client or initial provider of the instant test. Confirmation testing is necessary to rule out inaccurate findings, collection errors, and faulty testing devices. The certified laboratory will provide, in detail, the positive (or negative) quantitative levels for each panel that is being tested. They will also be able to test the validity of the specimen by assessing the physical attributes of the specimen.

Contact us today for more information!