Rapid Diagnostic Testing for HIV:
Clinical Implications of a New Diagnostic Tool

RAPID HIV TESTING LABORATORY LICENSURE REQUIREMENTS

In New Jersey, two sets of laboratory licensure requirements need to be fulfilled to offer rapid HIV testing. These requirements are based upon separate federal and New Jersey regulations.

Federal Regulations:

The Centers for Medicare and Medicaid Services (CMS) regulates all laboratory testing performed on humans (with the exception of research). It does so under the auspices of the Clinical Laboratory Improvement Act (CLIA), which originated in 1967. A laboratory is defined under CLIA 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.”

In 1992, CLIA implemented regulations based upon the complexity of the lab methodology dividing laboratory testing into groups that are either waived, moderate complexity, or high complexity. Waived laboratories must complete an application, enroll in CLIA, pay a fee, become certified and perform testing in accordance with the manufacturer’s product insert.

State Regulations:

With the exception of small group practices, numbering less than 4 physicians, clinical group practices and other organizations performing clinical laboratory testing are required to have a State of New Jersey Clinical Laboratory License. New Jersey regulations recognize only the original CLIA list of waived tests, not the complete list currently waived under federal regulations.

New Jersey regulations require interested parties to complete an application specifying the procedures to be performed, the personnel performing the procedures, the Bioanalytical Laboratory Director and furthermore require laboratories to participate in appropriate proficiency testing.