What are the 3 levels of CLIA testing?

What are the 3 levels of CLIA testing?

Current Regulation: CLIA established three categories of tests: waived tests, moderate complexity tests, and high complexity tests.

What are the levels of CLIA?

The regulatory requirements of CLIA vary based on the types of tests a laboratory performs. CLIA regulatory requirements classify testing into three categories: high complexity, moderate complexity and waived. There are five different types of CLIA certifications, and each is generally effective for two years.

What does CLIA 88 stand for?

Clinical Laboratory Improvement Amendments of 1988
The Clinical Laboratory Improvement Amendments of 1988 statute is an amendment to the Public Health Services Act in which Congress revised the federal program for certification and oversight of clinical laboratory testing. The law continues to be cited as CLIA ’88 as named in legislation.

What is considered a high complexity test?

High complexity tests include those that require clinical laboratory expertise beyond normal automation to perform. If the output of the data requires some expertise, these would also be highly complex.

What does the classification of waived test mean?

As defined by CLIA, waived tests are simple tests with a low risk for an incorrect result. Tests that the manufacturer applies to the FDA for waived status by providing scientific data that verifies that the CLIA waiver criteria have been met.

How many CLIA waived tests are there?

CLIA waived tests are generally simple test that are non-technical. There are over 1,400 test systems that have been waived. Most test meet the following requirements: Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible.

What are the four complexity levels of CLIA?

The FDA categorizes diagnostic tests by their complexity—from the least to the most complex: waived tests, moderate complexity tests, and high complexity tests.

What does CLIA stand for?

“CLIA” is the acronym for the Clinical Laboratory Improvement Amendments of 1988. This law requires any facility performing examinations of human specimens (e.g., tissue, blood, urine, etc.) for diagnosis, prevention, or treatment purposes to be certified by the Secretary of the Department of Health and Human Services.

What is CLIA approval?

The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing. Each agency has a unique role in assuring quality laboratory testing.

What is high complexity?

▪ High complexity. Medical decision making is defined by the complexity of a physician’s work that is necessary to establish a diagnosis and/or to select a healthcare management option.

Is histology considered high complexity testing?

Review of the CLIA categories of tests by complexity indicates that many tasks and tests performed in the histopathology laboratory are in fact of high complexity (CFR 42 §493.5, CFR 42 §493.17).

What are 3 examples of CLIA waived tests?

Examples of POCT include, but are not limited to:

• Glucometers for measuring blood sugar.
• Handheld chemistry analyzers to perform tests such as creatinine, electrolytes, hemoglobin, troponin, cardiac enzymes, and blood gases.
• Dipsticks for urine chemistry testing.
• Testing strips for vaginal pH.

How is the complexity of a CLIA test determined?

The final score determines whether the test system is categorized as moderate or high complexity. Tests developed by the laboratory or that have been modified from the approved manufacturer’s instructions default to high complexity according to the CLIA regulations. See 42 CFR 493.17.

What does a score of 1 mean on CLIA?

A score of 1 indicates the lowest level of complexity, and a score of 3 indicates the highest level. The scores for the 7 criteria are added together and tests with a score of 12 or less are categorized as moderate complexity, while those with a score above 12 are categorized as high complexity.

What are the requirements for CLIA’88 professional standards?

Professional standards administered via CAP and JCAHO are considered later. CLIA’88 regulations are based on four categories of test complexity: waived, provider performed microscopy (PPM), moderate complexity, and high complexity.

What does CLIA stand for in medical category?

CLIA Categorizations The FDA categorizes diagnostic tests by their complexity—from the least to the most complex: waived tests, moderate complexity tests, and high complexity tests.