What are the 3 categories of tests under CLIA regulations?

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

What does CLIA stand for laboratory?

Clinical Laboratory Improvement Amendments of 1988
“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.

Which of the following requirements must be met for a test to be CLIA waived?

Waived tests include test systems cleared by the FDA for home use and those tests approved for waiver under the CLIA criteria. Although CLIA requires that waived tests must be simple and have a low risk for erroneous results, this does not mean that waived tests are completely error-proof.

How many indicators of quality are required by CLIA?

The 14 laboratory quality indicators identified are grouped according to the stage of the total laboratory testing process.

What are 3 examples of CLIA waived tests?

As defined by CLIA, waived tests are “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.” Examples of waived tests include: dipstick urinalysis, fecal occult blood, urine pregnancy tests, and blood glucose monitoring.

What are CLIA requirements?

CLIA generally requires all facilities that perform even one applicable test, including waived tests, on “materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings” to meet …

What is the purpose of CLIA?

The Clinical Laboratory Improvement Amendments (CLIA) Program regulates labs testing human specimens and ensures they provide accurate, reliable, and timely patient test results no matter where the test is done.

What are 4 examples of CLIA waived tests?

The specific tests that are deemed to be CLIA waived are:

  • Non-automated urinalysis using dipstick or tablet reagents.
  • Ovulation tests.
  • Urine pregnancy tests.
  • Fecal occult blood.
  • Hemoglobin-copper sulfate.
  • Erythrocyte sedimentation rate.
  • Blood glucose monitoring utilizing devices specifically for home use.
  • Spun microhematocrit.

What are 3 phases of laboratory testing?

Total testing process in the laboratory is a cyclical process divided into three phases: preanalytical, analytical and postanalytical.

What are laboratory indicators?

Indicators are Chemicals which are used to test whether a given substance in an acid or base. Eg:- phenolphthalein, etc. Muxakara and 8 more users found this answer helpful.

What are 7 considerations that should be made regarding waived testing?

Considerations Before Introducing Waived Testing or Offering a New Waived Test

  • Management responsibility for testing.
  • Regulatory requirements.
  • Safety.
  • Testing space and facilities.
  • Benefits and costs.
  • Staffing.
  • Documents and records.

Is a CBC a CLIA waived test?

Regulatory Roundup: January-February 2018 This is the first CBC test to receive a CLIA waiver, enabling non-traditional laboratory sites, such as physicians’ offices, and nonmedical staff to perform it.