N.J. Admin. Code § 8:44-2.2

Current through Register Vol. 56, No. 9, May 6, 2024

Section 8:44-2.2 - Applicability of regulations

(a) Except as otherwise provided herein, the regulations shall apply to clinical laboratories engaged in the performance of chemical, bacteriologic, virologic, parasitologic, serologic, mycologic, hematologic, immunohematologic, biophysical, cytologic, radiobioassay 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.

(b) The rules do not apply to the following:

1. Anatomic pathology, which is defined as the gross or microscopic examination of tissues by a physician specifically trained to interpret and diagnose disease by such examination;

2. Clinical laboratories operated and maintained exclusively for research and teaching purposes, involving no patient or public health services, whatsoever;

3. Clinical laboratories operated by the United States Government;

4. Blood banks licensed under P.L. 1963, c.33 (26:2A-2 et seq.);

5. Clinical laboratories possessing a Federal Certificate of Waiver as defined by Federal Clinical Laboratory Amendments of 1988 (CLIA '88) ( P.L. 100-578 ) and regulations adopted thereunder ( 42 CFR Part 493, published in the Federal Register, February 28, 1992); and

6. Clinical laboratories which are operated by the Department of Corrections, any county jail, any county probation department, or any drug or alcohol treatment center providing services to persons under the jurisdiction of any of these agencies or in a program of supervisory treatment pursuant to the provisions of N.J.S. 2C:43-13 and which perform only urinalysis for screening purposes to detect the presence of alcohol or illegal substances. The Attorney General shall approve procedures, methods and devices used by these agencies or centers in screening for alcohol or illegal substances.

N.J. Admin. Code § 8:44-2.2

Amended by R.1993 d.200, effective 5/17/1993.
See: 25 New Jersey Register 668(a), 25 New Jersey Register 1969(b).
Added exception at (b)5.
Amended by R.1993 d.595, effective 11/15/1993.
See: 25 New Jersey Register 3904(a), 25 New Jersey Register 5164(a).