So do I need a CLIA Waived iCassette drug test? Let me give you some history, back in 1988 Congress passed the Clinical Laboratory Improvement Amendments commonly referred to as CLIA.
The purpose of CLIA was to establish quality standards for all laboratory testing to ensure accuracy, reliability, and timeliness of patient test results. Under the responsibility of the FDA, these commercially marketed In-vitro drug test kits were to be of moderate or high complexity to ensure lowered risks to the public health.
Let me ask you some questions in the determination of whether you should use a CLIA Waived test kit or not.
- Is your business a laboratory?
- Are you screening patients for diagnosis?
- Are you screening for the purpose of disease prevention?
- Are you screening for the treatment of disease?
- Are you screening for the assessment of health?
- Are you screening for the assessment of an impairment?
- Is your patient a human being?
Examples of when a CLIA Waiver is not needed.
Any employment situation where you are testing employees or persons taking a pre-employment drug or alcohol test to hire on and go to work for a company. Random drug testing programs or a situation where a drug test is given to remain eligible to stay in a program or to continue getting benefits does not require a CLIA Waiver.
Examples of when a CLIA Waived test is required:
The waiver is definitely needed if you are a doctor's office or work in pain management medical weight loss clinic or you are a doctor giving a drug test as a pre-screen to learn more about what may be going on with a patient. Also if you are a laboratory that tests human specimens.
The following drug testing products are classified as CLIA Waived to meet the needs of your testing facility. CLIA Waived drug tests have been cleared through a review process of two U.S. government agencies: the FDA and HCFA, the objective of this is to determine that errors in operation will be minimized and that inaccurate test results will not endanger the life of the patient
So let us review:
A laboratory is any facility that does laboratory testing on specimens derived from humans to give information for the diagnosis, prevention, treatment of disease, or impairment of or assessment of health.