45:9-42.27 Definitions.
As used in this act:
a. "Clinical laboratory" , except as used in subsection k. of this section, means any facility used for the performance of chemical, bacteriologic, virologic, parasitologic, serologic, hematologic, immunohematologic, biophysical, cytologic or other examinations of materials derived from the human body for the purpose of yielding information for the diagnosis, prevention or treatment of disease or the assessment of medical condition. Any facility used for the collection, processing and transmission of specimens to another facility for the performance of clinical tests falls within the purview of this act.
b. "Department" means the Department of Health.
c. "Commissioner" means the Commissioner of Health or his duly authorized agent.
d. "Clinical laboratory owner" means a person or agency in whom is vested the rights of control, possession, and dominion of a clinical laboratory and for the purposes of this act shall include a county, municipality, or any other owner of an institution operating a clinical laboratory.
e. "Clinical laboratory director" means a person who is responsible for the administration of the technical and scientific operation of a clinical laboratory, including, but not limited to, supervision of procedures for testing and reporting of results. Nothing in this act shall be deemed to exempt the director of a clinical laboratory from the licensure requirements of P.L.1953, c.420 (C.45:9-42.1 et seq.), where such requirements would otherwise be applicable.
f. "Clinical laboratory evaluation program" means a program of evaluating the proficiency of clinical laboratories by the department.
g. "Anatomic pathology" means the gross or microscopic examination of tissues by a physician specifically trained to interpret and diagnose disease by such examination.
h. "Person" means any individual, partnership, limited partnership, corporation or other legal entity.
i. "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; 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.
j. "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. 493.15c.
k. "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.1975, c.166, s.2; amended 2016, c.86, s.5.