45:9-42.2 Definitions.

As used in this act, the following terms are defined as follows:

a. "Board" means the State Board of Medical Examiners which shall have authority to examine and license bio-analytical laboratory directors as set forth in this act. The board is authorized to make necessary rules to implement the provisions of this act.

b. "License" means a license granted and issued by the board under this act to any person who makes application therefor and fulfills the requirements set forth by this act. A license shall be either a plenary or specialty license issued pursuant to the provisions of section 7 of P.L.1953, c.420 (C.45:9-42.7).

c. A "Bio-analytical Laboratory" is any place, establishment or institution organized and operated primarily for the performance of chemical, microscopic, serological, parasitological, bacteriological or any other tests, by the practical application of one or more of the fundamental sciences, to material originating from the human body, for the purpose of obtaining scientific data which may be used as an aid to ascertain the state of health. The interpretation of cytologic and histologic criteria of disease is not considered to be within the scope of this definition of a bio-analytical laboratory.

d. A "Bio-analytical Laboratory Director" is any person licensed and qualified to manage and direct the technical work in a bio-analytical laboratory as defined in this act.

e. "Point-of-care laboratory testing" means use of a laboratory testing instrument, kit, or test to which the following applies:

(1) The testing instrument, kit, or test is designed to be used at or near the site of the patient for whom the test or examination is being conducted;

(2) The testing instrument, kit, or test is used to perform testing outside the physical facilities of a certified clinical laboratory; and

(3) The testing instrument, kit, or test:

(a) is used to perform waived tests or moderate complexity clinical laboratory tests or examinations classified under the federal "Clinical Laboratory Improvement Amendments of 1988," Pub. L. 100-578 (42 U.S.C. s.263a) and any regulations adopted pursuant thereto;

(b) is used to perform tests or examinations on biological specimens that require no preparation after collection, except use of a reagent; and

(c) is used to perform tests or examinations without the necessity for testing personnel to perform calibration or maintenance, except resetting pursuant to the manufacturer's instructions or basic cleaning or disinfecting; and

(4) For moderate complexity testing, the testing instrument, kit, or test is used in accordance with the patient test management system, the quality control program, and the comprehensive quality assurance program established and maintained by the laboratory pursuant to the standards established under the "Clinical Laboratory Improvement Amendments of 1988," Pub.L.100-578 (42 U.S.C. s.263a), any regulations adopted pursuant thereto, and any other procedures currently or subsequently approved by the federal Centers for Medicare & Medicaid Services and specified in Appendix C of the State Operations Manual.

f. "Waived test" means a test system, assay, or examination that is authorized as "waived" by the federal Food and Drug Administration or authorized as "waived" by the federal Department of Health and Human Services and currently or subsequently listed in 42 C.F.R. 493.15(c).

g. "Certified clinical laboratory" means a clinical laboratory certified pursuant to the "Clinical Laboratory Improvement Amendments of 1988," Pub.L.100-578 (42 U.S.C.s.263a), but does not include a clinical laboratory possessing a certificate of waiver issued pursuant to 42 U.S.C.s.263a(d)(2) and any regulations adopted pursuant thereto.

L.1953, c.420, s.2; amended 1981, c.314, s.1; 2016, c.87, s.1.