Clinical Laboratory - Fundamentals

Physican Office Testing

CLIA-waived tests

FDA approved tests done in a clinical laboratory have gone through a rigorous validation process for a specific purpose (a specified disease or condition). Medicare and other agencies or insurers may deem tests that have not undergone this process as "experimental" or without proven clinical utility, even though such tests may be widely used. For example, one may obtain a plasma TNF-alpha, but it is not FDA approved for any purpose and therefore deemed experimental and likely not to be reimbursed.

A Physician's Office Laboratory (POL) may not be subject to the rigorous licensing and inspection requirements as a regular hospital or commerical laboratory. However, the POL may only perform certain "CLIA" waived tests (Clinical Laboratory Improvement Amendments of 1988), typically those tests that serve a purpose for "point of care testing" (POCT) and are not complex to perform.

What is a "CLIA-waived" test? As currently defined in the regulation, waived tests are simple laboratory examinations and procedures that:

1. Are cleared by the Food and Drug Administration (FDA) for home use;

2. Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or

3. Pose no reasonable risk of harm to the patient if the test is performed incorrectly.

The highest volume CLIA-waived tests are: Urinalysis (usually dipstick) Pregnancy test (qualitative) Glucose Fecal occult blood Lipid panel (cholesterol)

Provider-performed microscopy procedures may include moderately complex microscopy including vaginal wet mounts, cervical mucus, and urine microscopic examination. Complex testing, including cytopathology and tissue biopsy specimens, goes to an approved laboratory.

Point-of-care-testing (POCT)

A single POCT test may be more expensive because the tests are done singly and at low volume. However, overall costs of health care may be reduced by obtaining a result faster to inform a treatment plan that may restore health quicker, avoid adverse complications of delay in diagnosis, and avoid further office visits or referrals.and at overall lower cost.

POCT must adhere to performance standards, with proper collection of a specimen to avoid a false negative result from a patient sample improperly collected or of insufficient amount. POCT must be performed in a clean environment, away from the place of collection, to avoid specimen contamination and false positive results.

Translational Research

The goal of medical research is development of tests, procedures, and treatments to improve health care. Research protocols are carefully crafted and must meet rigorous standards for informed consent, monitoring, and reporting. Laboratory testing developed in a research environment must undergo extensive validation, both in initial trials and in more general circumstances of usage, before approval for use in routine medical practice by the FDA.

The elements of transformation of new basic science knowledge through research projects into a clinical application with importance to health care delivery include:

• Basic science translated to a clinical application;
• A clinical application translated into an effective treatment; and
• An effective treatment translated into a health care delivery system.