Almost all point of care drug tests are advertised as CLIA waived. Customers often want to know what does CLIA waived mean, and why is it so important?
CLIA stands for Clinical Laboratory Improvement Amendments. CLIA is a set of guidelines and regulations that are jointly enforced by the CDC (Center for Disease Control), CMS (Centers for Medicare and Medicaid Services) and FDA (Food and Drug Administration).
In its most basic form the FDA categorizes all diagnostic tests according to complexity. There are 3 levels of complexity:
- High Complexity
- Moderate Complexity
CLIA Waived Drug Tests
For a test to be waived it must :
- Require minimal scientific and technical knowledge to perform the test and the knowledge must be easily obtained through on the job instruction with minimal training.
- Regeants must be pre-packaged, reliable, stable and require no special handling, precautions, or storage.
- Operational is automatic or easily controlled.
- Calibration, Quality Control & external proficiency testing materials must be readily available and stable.
- Test system troubleshooting is automatic or self correcting, or clearly described and requires minimal judgement.
- Minimal interpretation and judgement are required to analyze results.
- Have been issued a CLIA waiver and number by the FDA.
Basically a CLIA waived test is a test that can be performed by anyone at home or in any setting without special raining or certification. Besides the requirements for being fool proof, a test must apply and receive a CLIA waiver or be amended onto an existing CLIA waiver with updated inserts and labeling. Someone can build a drug test identical to our CLIA waived 12 Panel Test and it wouldn’t be considered CLIA waived until they were issued the waiver by the FDA.
For a multi-panel drug test each strip and the device must be covered under the waiver, however enforcement is carried out at the state level and many states do not strictly enforce this. Every strip on the test must be CLIA waived for the test to be CLIA waived. Most states have employees within their state health departments that are contracted directly with the CMS as CLIA surveyors.
Some states have their own licensure and infrastructure for enforcing CLIA. Their regulations are usually more stringent, but at the very least meet the federal requirements.
At the time of this publication the only two states with independent licensure are Washington and New York. Washington’s program is run by the Office of Laboratory Quality Assurance and New York’s program is called the Clinical Laboratory Evaluation Program under the State of New York Department of Health.
For a test to be CLIA waived the FDA must inspect the facility where it is manufactured. During the Coronavirus pandemic the FDA suspended drug and medical device inspections. For the majority of drug tests an existing CLIA waiver is amended for slight changes to labeling and recently waived tests are produced by facilities that are already producing CLIA waived drug tests.
Just because a drug test is advertised or labeled as CLIA waived does not mean it really is. The only sure way to check is to see if the test and all its component strips are listed correctly in the FDA CLIA medical device database.
According to Alicia Williams, a CLIA Surveyor for the state of Oklahoma, many drug test cups that are re-labeled do not file the appropriate paperwork with the FDA and even though they are advertised as CLIA waived they do not meet the guidelines. Suppliers often sell these tests for months and potentially thousands of labs, healthcare facilities and other businesses are using tests that they believe are CLIA waived but aren’t.
Reasons You May Need a CLIA Waiver
You will need a CLIA waiver if you plan on charging someone for testing and do not have an employee that is properly certified in conducting moderate or high complexity tests.
You will need a CLIA waiver if you charge insurance for drug testing at a medical practice.
You will need a CLIA waiver to test employees if you do not have staff properly certified in conducting moderate or high complexity tests.
CLIA waivers are not available for all types of drugs and it can take years for a facility to get new drugs issued for existing or new waivers. In this case tests can be used “for forensic use only”. For example it currently isn’t possible to get a fentanyl test that is CLIA waived, but the drug is becoming more popular. Some professionals will order a single panel fentanyl strip in addition to a CLIA waived 12 panel cup so they can send a sample for laboratory confirmation if it fails for fentanyl, but for all other purposes their testing is covered by CLIA.
For a laboratory to perform high complexity tests the Executive Director has to be a certified pathologist or have a P.H.D. with related board certification and each technician has to have an Associates Degree minimum.
Even though a test is very simple if the distributor does not complete the required filings and their tests are not listed on the FDA’s CLIA medical device database you still need the infrastructure and certifications that a high complexity lab would need.
“Oklahoma CLIA surveyors can be contacted through email and cell phone. We encourage laboratories or potential laboratory personnel to ask questions. We believe in a partnership between the laboratory and the CLIA State Agency to deliver accurate laboratory test results.”
–Alicia Williams, BS, MS, MLS (ASCP)
Clinical Health Facility Surveyor
Oklahoma State Department of Health
The personnel on staff in your state are usually happy to help with any questions you have. According to Alicia Williams, a clinical health facility surveyor for the state of Oklahoma, “Oklahoma CLIA surveyors can be contacted through email and cell phone. We encourage laboratories or potential laboratory personnel to ask questions. We believe in a partnership between the laboratory and the CLIA State Agency to deliver accurate laboratory test results.”.
For information on the CLIA status of any of our products please Contact Us with your questions.