CLIA Hits Questionable Tests

Stephen Barrett, M.D.
March 9, 2004

The Centers for Medicare & Medicaid Services (CMS) has announced that four “nontraditional” laboratory tests are not permissible unless the laboratory providing them is approved for “high-complexity testing” as defined under the Clinical Laboratory Improvement Act (CLIA) Program. Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 to establish quality standards for all laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed. A laboratory is defined as any facility which performs laboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention, treatment of disease, or impairment of, or assessment of health.

The final CLIA regulations published on February 28, 1992 are based on the complexity of the test method; thus, the more complicated the test, the more stringent the requirements. Three categories of tests have been established: waived complexity, moderate complexity (including provider-performed microscopy) and high complexity. CLIA specifies quality standards for proficiency testing, patient test management, quality control, personnel qualifications and quality assurance for laboratories performing moderate and/or high complexity tests. Waived laboratories must enroll in CLIA, pay the applicable fee and follow manufacturers’ instructions. Because problems in cytology laboratories were the impetus for CLIA, there are also specific cytology requirements.

The Centers for Medicare & Medicaid Services (CMS) is charged with the implementation of CLIA, including laboratory registration, fee collection, surveys, surveyor guidelines and training, enforcement, approvals of proficiency testing providers, accrediting organizations, and exempt states. The Centers for Disease Control and Prevention (CDC) is responsible for the CLIA studies, convening the Clinical Laboratory Improvement Amendments Committee (CLIAC) and providing scientific and technical support/consultation to CMS. The FDA is responsible for test categorization. To enroll in the CLIA program, laboratories must first register by completing an application, pay fees, be surveyed (if applicable), and become certified.

To curb the use of certain tests that lack a scientific basis or are unsubstantiated, the CLIA Program has established a rule that any laboratory doing such tests must be CLIA-certified for high-complexity testing. Unapproved providers can be sanctioned under either federal or state laws that regulate laboratory use. Live blood cell analysis, biological terrain assessment, dental sensitivity testing, and cytotoxic testing are covered by this requirement. The listing of live cell analysis was triggered by a complaint I made in 1996 against three chiropractors in Allentown, Pennsylvania who were using it as a gimmick to attract patients and sell enzyme pills. This CLIA alert summarizes the current policy toward these tests.


[Alternative – Non-Traditional Laboratory Testing]

Live Blood Cell Analysis (LBA) is a test which is used for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or assessment of the health of human beings. The Health Care Financing Administration (now the Centers for Medicare & Medicaid Services) Office of General Counsel (OGC) determined in August, 1997, that LBA was subject to all CLIA requirements. Therefore, any facility performing this procedure must be certified by CLIA and must obtain the correct certificate. Failure to comply with any of the CLIA requirements will result in enforcement actions and/or sanctions being taken.

In January, 1996, the Centers for Disease Control (CDC), determined that the LBA test procedure automatically defaulted to high complexity because it had not been categorized by CDC. Therefore, any facility performing this test must meet all CLIA requirements for high complexity testing: Patient Test Management; Proficiency Testing; Quality Control; Personnel, and Quality Assurance. Therefore any facility performing LBA must hold a valid registration certificate, Certificate of Compliance, or Certificate of Accreditation. LBA is not a Provider-Performed Microscopic Procedure (PPMP) test. LBA is also a non-covered Medicare service. CLIA Regulations (CDC Website)

LBA is performed by placing a drop of blood from the patient’s fingertip on a microscope slide under a glass coverslip to keep it from drying. [NOTE: In some cases, a powder has been developed that when sprinkled on the blood will form a type of “coverslip”]. The slide is then viewed at high magnification with a dark-field microscope that forwards the image to a television monitor. The results are then used for prescribing nutritional supplements.

LBA is also known as Hemaview, Free Radical Blood Screening, etc.

Other examples of Alternative Testing (Non-Traditional Laboratory Testing) that are subject to CLIA:

Biological Terrain Assessment (BTA): BTA is a computerized analysis of blood, urine, and saliva specimens used to recommend nutritional programs, vitamin and mineral supplements, homeopathic products, and/or herbs. Analysis is determined through pH determinations. A portion of the test is legitimate: pH. . . .

Dental sensitivity testing: This test determines whether one is sensitive to materials in fillings. If sensitive, all fillings can be removed and replaced. All reviewing agencies could not determine whether the method was valid.

Cytotoxic Testing (Food Allergy Testing): Cytotoxic testing involves taking about 10 ccs of blood from a patient. The white blood cells (WBCs/leukocytes) are mixed with plasma and sterile water and placed on microscopic slides, after each slide has been coated with the dried extract of a particular food. The reaction of the cells to the extracts is then examined under a microscope. If the cells collapse, disintegrate, or change shape, the patient is supposedly allergic to that particular food. This evidence of food allergy is then used to explain a variety of symptoms. To correct this condition, the clinic offers a personalized diet program which includes vitamin and mineral supplements. Also called Brian’s Test or Leukocyte Antigen Testing.

To obtain further information on LBA and other alternative laboratory testing, please contact your State Survey Agency or CMS Regional Office.

Last modified on Wednesday, April 24, 2002

Except for freestanding commercial laboratories, blood banks, hospitals, and large medical offices, very few facilities have high-complexity approval. Only a few states restrict the use of unestablished laboratory tests. Nevertheless, if you encounter any practitioner who does live blood cell analysis, biological terrain assessment, dental sensitivity testing, or cytotoxic testing and is not obviously running a laboratory, please ask your state laboratory department to investigate.

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This article was posted on March 9, 2004.