New Jersey Administrative Code
Title 10 - HUMAN SERVICES
Chapter 61 - INDEPENDENT CLINICAL LABORATORIES
Subchapter 1 - GENERAL PROVISIONS
Section 10:61-1.2 - Definitions

The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise:

"Automated multichannel tests" means laboratory tests which can be and are frequently performed as groups and combinations (profiles) on automated multichannel equipment.

"CLIA" means the Clinical Laboratory Improvement Amendments of 1988, which extends the scope of Federal governmental regulation of laboratories to all laboratory sites where laboratory tests are performed, including physicians' offices. The purpose of this legislation is to uniformly ensure the quality and reliability of medical tests performed by all laboratories that test human specimens.

"CLIA Identification Number" means a 10 digit identification number issued by the Centers for Medicare & Medicaid Services (CMS) to independent clinical laboratories and other entities which perform laboratory testing. A CLIA Identification Number must be on file with the New Jersey Medicaid/NJ FamilyCare program before payment is made for any laboratory testing.

"Clinical laboratory services" means professional and technical laboratory services provided by an independent clinical laboratory when ordered by a physician or other licensed practitioner of the healing arts within the scope of his or her practice as defined by the laws of the state in which he or she practices.

"Panel" means laboratory tests that are associated with organ or disease oriented areas, such as organ "panels" (for example, hepatic function panel). The tests listed with each panel identify the defined components of that panel.

"Profile" means a combination of laboratory tests that can be and are frequently done as groups and in combinations on automated multi-channel equipment (for example, SMA6, SMA).

"Reference laboratory" means a laboratory meeting the requirements stipulated in 10:61-1.4 which performs specific tests at the request of another approved certified laboratory.

"Service laboratory" means a laboratory meeting the requirements stipulated in 10:61-1.4 which performs specific tests on the laboratory's own premises.