section .0100 - DEFINITIONS
13 NCAC 20 .0101 DEFINITIONS
As used in G.S. 95, Article 20 and this Chapter:
(1) "All actions" means procedures performed
on the sample to detect, identify, or measure controlled substances. Examples
include, but are not limited to, "examinations and screening for
controlled substances," "controlled substances testing," "drug
testing," "screening," "screening test," "confirmation,"
and "confirmation test".
(2) "Chain of custody" means the process of
establishing the history of the physical custody or control of the sample from
the time the examiner provides the container for the sample to the examinee
through the later of:
(a) The reporting of the negative result to the
(b) The 90 day period specified in G.S.
(c) The completion of the retesting described in
(3) "On-site" means any location, other than
an approved laboratory, at which a screening test is performed on prospective
employees. For example, "on-site" locations include, but are not
limited to, the examiner's place of business or a hospital, physician's office,
or third-party commercial site operated for the purpose of collecting samples
to be used in controlled substance examinations.
(4) "Sample" means the examinee's urine,
blood, hair or oral fluids obtained in a minimally invasive manner and
determined to meet the reliability and accuracy criteria accepted by
laboratories for the performance of drug testing.
(5) "Employer or person charged" means an
examiner found by the Commissioner to have violated G.S. 95, Article 20.
(6) "Preliminary screening procedure" means a
controlled substance examination that uses a single-use test device that:
(a) Is portable and can be administered on-site;
(b) Meets the requirements of the U.S. Food and
Drug Administration for commercial distribution contained in Title 21, Part 807
of the Code of Federal Regulations; and
(c) Meets the generally accepted cutoff levels
contained in the Mandatory Guidelines for Federal Workplace Drug Testing
Programs adopted by the U.S. Department of Health and Human Services' Substance
Abuse and Mental Health Services Administration in 69 FR 19644.
(7) "Single-use test device" means the
reagent-containing unit of a test system that:
(a) Is in the form of a sealed container or
cartridge that has a validity check, a nonresealable closure, or an evidentiary
tape that ensure detection of any tampering;
(b) Is self-contained and individually packaged;
(c) Is discarded after each test; and
(d) Does not allow any test component or
constituent of a test system to interact between tests.
History Note: Authority G.S. 95-231; 95-232; 95-234;
Eff. April 1, 2001;
Temporary Amendment Eff. January 16, 2002;
Amended Eff. July 1, 2003;
Temporary Amendment Eff. November 30, 2006;
Amended Eff. February 1, 2007.