NEW YORK - CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA)

1. Are physicians subject to the CLIA regulations?

Yes. Physicians are subject to CLIA regulations, but only if they have a laboratory as part of their office. The CLIA amendments were enacted to extend the regulation by the U.S. Department of Health and Human Services (HHS) from the 13,000 laboratories already regulated by HHS to an estimated 200,000 lab sites, including those located in physicians' offices. Generally, CLIA changed the focus of clinical lab regulation from regulation based on the type of laboratory site to regulation based on the complexity of the tests performed by a particular laboratory.

All laboratories performing tests on human specimens must register with the Health Care Financing Administration (HCFA). Registration requires a fee ranging from $100 to $600. All laboratories must also submit to a federal inspection every two years, which will result in an additional fee ranging between $300 and $3,100. Laboratories are also subject to a proficiency test three times a year in which their analyses of test specimens will be verified for accuracy. Registration certificates are valid for a maximum of two years or until such time as an inspection can be conducted to determine program compliance, whichever is shorter.

2. Do CLIA regulations apply to all practices, even where relatively few and simple tests are performed?

Yes. CLIA regulations apply to all laboratory testing used for the assessment of health or for the diagnosis, prevention, or treatment of disease. CLIA applies to every laboratory and testing site in the United States, even if only a few basic tests are performed as part of physical examinations.

Certain laboratories, however, may obtain a certificate of waiver for a fee of $100 if they can prove that the tests they perform are exempt from specific CLIA requirements. (See following.) These laboratories are nonetheless required to register with HCFA when applying for a certificate of waiver.

3. Which tests are exempt from CLIA requirements?

Eight tests have been designated as exempt from CLIA standards and a laboratory that performs only these tests can obtain a certificate of waiver from CLIA requirements. The eight tests are:

A. Dipstick or tablet urinalysis (non-automated);

B. Fecal occult blood;

C. Ovulation tests using visual color comparisons;

D. Urine pregnancy tests using visual color comparisons;

E. Erythrocyte sedimentation rate (non-automated);

F. Hemoglobin by copper sulfate method (non-automated);

G. Spun microhematocrit;

H. Blood glucose using certain devices cleared by the Food and Drug Administration (FDA) specifically for home use.

Laboratories with certificates of waivers will not be inspected routinely but will still be subject to inspections as part of complaint investigations and on a random basis to determine whether only the waived tests are being performed.

In 1992, HCFA created a new category of procedures which are not subject to routine inspections. The tests include:

A. Physician-performed microscopy procedures including wet mounts, including preparations of vaginal, cervical or skin specimens;

B. All potassium hydroxide preparations;

C. Pinworm examinations;

D. Fern tests;

E. Post-coital direct, qualitative examinations of vaginal or cervical mucous; and

F. Urine sediment examinations.

4. How are laboratories which perform tests not listed on the exempt list regulated?

All tests not listed as waived are divided into one of two categories, moderate complexity or high complexity, based on the complexity of the testing procedure. For these categories, the regulations list specific requirements for proficiency testing, patient test management, quality control, quality assurance, personnel, and inspections.

Some examples of moderate complexity tests are microscopic analysis of urinary sediment, throat cultures, Gram stains, and hematology and chemistry tests conducted on fully automated instruments that do not require operator intervention during the analytic process.

5. What are the major differences between the requirements for laboratories performing tests of moderate and high complexity?

The major differences concern quality control and personnel standards. Personnel standards for facilities doing high complexity testing will require more education and experience than for those doing only moderate complexity testing. The Moderate Complexity classification has requirements for the laboratory director, clinical consultant, technical consultant and testing personnel while the High complexity classification has requirements for the laboratory director, clinical consultant, technical supervisor, general supervisor and testing personnel.

(See Appendix for complete requirements.)

(42 CFR 493.1403-1425; 42 CFR 493.1441-1495)

6. How do New York's regulations on the operation of clinical laboratories differ from the Federal CLIA regulations?

On August 28, 1995 the HCFA granted an exemption from the CLIA regulations to all laboratories located in the state of New York possessing a valid New York State permit to perform laboratory testing.¹ The HCFA determined that the New York Clinical Laboratory Evaluation Program (Public Health Law Article V, Title V) and its regulations (10 N.Y.C.R.R. 19, 58, 63, and 7190) met or exceeded the federal CLIA regulations. As New York is one of the states with a federally-approved licensure program, a laboratory may obtain a state license in lieu of a federal certificate.

(See http://www.wadsworth.org/labcert/clep/clep.html)

¹ This exemption excluded laboratories operated by an individual licensed physician, osteopath, dentists, podiatrist, or a physician’s group practice performing laboratory testing solely for the benefit of its own patients.