False positive/negative drug tests. What you can do. US only
Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. Enforcement has been lax due in large part to a lack of awareness on the part of the public as to their rights in the testing process.
The drug test you are given is no better than the test used (and they vary widely in accuracy) and/or the qualifications of the laboratory and technicians performing the tests (even more varied than the tests).
If you feel that a drug test was inaccurate you can take the following action:
First, in writing, protest the inaccuracy of the test to every person and agency or organization involved in the testing process. Do not go into great detail. A statement that “the test was inaccurate and damaging” is sufficient. In that correspondence request the complete identification of the particular test used, a.
brand name and b.
CLIA and/or FDA certification number for the test, and request the c.
laboratory certification number for each agency or organization involved in the testing process and d.
the chain of custody form (COC). [Each person that handled your sample had to sign this] The COC is a very important document. If it is not maintained the test is without value. If it was handled by unqualified individuals you can determine that.
If you already know the name of the testing agencies (ex. Physician, laboratory, etc) you can check their certification by going to: LABORATORY LOOKUP
You can lookup any laboratory by a.
name or b
. Ten digit ID number or by c.
region at this website.
Once you identify the laboratory(ies) involved you should send a copy of your complaint to the CLIA Regional Office for your region. You can get that address here: CLIA REGIONAL OFFICE LOCATOR
A copy of your complaint should be sent to your state agency responsible for laboratory regulation. The responsible agency for your state can be found at: STATE REGULATORY AGENCIES
Certain tests do not have to be certified by CLIA but still must have an FDA waiver. These are mostly the tests sold for home/personal use. Usually available by mail or OTC. You have the right to know the brand name and identification of any test that was performed on you. You can then check the test against the Federal Drug Administration list to see if it is exempted, and for what uses, at TESTS WAIVED BY FDA Note:
Drug tests are exempted for specific reasons. It is not a blanket exemption. Most of the waivers are issued for home use only. Some companies may order home drug tests and use them for in-house employee drug testing, for instance. That is not allowed. So look up the test and also read the FDA waiver restrictions.
File your complaint with other accrediting agencies. CLIA sometimes delegates accreditation to one of 6 other approved organizations (ex. College of American Pathologists). So the lab may be certified by one of these other agencies, in which case a complaint would also be filed with that organization. Those 6 agencies are listed here: OTHER ACCREDITING AGENCIES
Even if it is certfied by another approved regulatory body, send an information copy to the CLIA Regional Office and the other agencies listed above.
You can check on any past legal actions taken against a certified laboratory at LABORATORY REGISTRY