The Law (Public Law 100-578)
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) law specified that laboratory requirements be based on the complexity of the test performed and established provisions for categorizing a test as waived. Tests may be waived from regulatory oversight if they meet certain requirements established by the statute. The section of the statute specifying the criteria for categorizing a test as waived was excerpted without elaboration in the regulations at 42 CFR 493.15(b) and 493.15(c) contained a list of these waived tests as described below.
The Regulations (42 CFR part 493)
On February 28, 1992, regulations were published to implement CLIA. In the regulations, waived tests were defined as simple laboratory examinations and procedures that are cleared by the Food and Drug Administration (FDA) for home use; employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or pose no reasonable risk of harm to the patient if the test is performed incorrectly.
The specified tests that are listed in the regulation are:
Dipstick or Tablet reagent urinalysis (non automated) for the following:
- Specific gravity
- Fecal occult blood
- Ovulation tests - visual color comparison tests for luteinizing hormone
- Urine pregnancy tests - visual color comparison tests
- Erythrocyte sedimentation rate-non-automated
- Hemoglobin-copper sulfate - non-automated
- Blood glucose by glucose monitoring devices cleared by the FDA specifically for home use
- Spun microhematocrit
- (added 1/19/93) Hemoglobin by single analyte instruments with self-contained or component features to perform specimen/reagent interaction, providing direct measurement and readout
In November 1997, the CLIA waiver provisions were revised by Congress to make it clear that tests approved by the FDA for home use automatically qualify for CLIA waiver. Professional use versions of home use tests are not automatically waived. However, such professional versions do qualify for expedited waiver review since only the differences between the home use and professional use versions need to be examined to determine whether the professional version qualifies for waiver.
To summarize, under the current process, waiver may be granted to: 1) any test listed in the regulation, 2) any test system for which the manufacturer or producer applies for waiver if that test meets the statutory criteria and the manufacturer provides scientifically valid data verifying that the waiver criteria have been met, and 3) test systems cleared by the FDA for home use.