Current through Register Vol. 56, No. 18, September 16, 2024
(a) "Minor violation" means any violation of the
requirements of this chapter or of any order issued pursuant to this chapter
pertaining to laboratory administration procedures or to any laboratory operating
procedures, other than specific analytical procedures. Minor violations include, but
are not limited to, noncompliance with requirements pertaining to laboratory
management procedures, failure to submit required fees, and failure to respond to
notices of deficiencies that have not directly affected data quality. Violations of
specific provisions of this chapter that are defined as minor violations include,
but are not necessarily limited to:
1.
7:18-1.4(e), failure to
display certification;
2.
7:18-2.11, noncompliance with
requirements relating to managerial and supervisory duties;
3.
7:18-2.12(a)2 and 3,
noncompliance with those criteria for compliance sample acceptance and analysis
relating to personnel qualifications and laboratory management;
4.
7:18-2.14(c), failure
to notify the Department of a change in the location of the laboratory;
5.
7:18-2.14(g), failure
to notify the Department of the completion of corrective action;
6.
7:18-2.19(a), failure
to report personnel changes;
7.
7:18-2.22(b)1, failure
to obtain required written statements and disclaimers; and
8.
7:18-3.2, noncompliance with laboratory
facility and safety requirements.
(b) "Moderate violation" means any violation of
the requirements of this chapter or of any order issued pursuant to this chapter
that directly affects the quality of laboratory data. These violations include, but
are not limited to, noncompliance with those requirements pertaining to analytical
procedures, quality control, data validity and integrity, chain-of-custody,
laboratory performance, data reporting and sample collection, recordkeeping, and
handling and preservation. A failure to make available or to maintain complete
records is equivalent to a violation that directly affects data quality, because the
Department is unable to verify facts relevant to data quality without adequate
records. Violations of specific provisions of this chapter that are defined as
moderate violations include, but are not necessarily limited to:
1.
7:18-2.10, noncompliance with laboratory
personnel qualification requirements;
2.
7:18-2.14(f), failure
to submit a corrective action plan in response to an audit within the time period
provided;
3.
7:18-2.22(b)2, failure
to provide notification along with report of analysis results that the analysis
results are not to be used for regulatory purposes;
4.
7:18-2.12(b), failure
to follow requirements and criteria in approved method, or
7:18-2.22(a), 4.3(a),
5.3(a), 6.4(a), 8.3(a), use of unapproved methods;
5.
7:18-3.3, noncompliance with
requirements for laboratory equipment, supplies, materials and
instrumentation;
6.N.J.A.C. 7:18-4,
noncompliance with microbiological testing procedures, including equipment
requirements, chain of custody procedures, quality control procedures, standard
operating procedures, record keeping and data reporting procedures;
7.N.J.A.C. 7:18-5, noncompliance with chemical
testing procedures including equipment requirements, chain of custody procedures,
quality control procedures, standard operating procedures, recordkeeping and data
reporting procedures;
8.N.J.A.C. 7:18-6,
noncompliance with radiochemical testing procedures including equipment
requirements, radon gas progeny test procedures, chain of custody procedures,
quality control procedures, standard operating procedures, record keeping and data
reporting procedures;
9.N.J.A.C. 7:18-7,
noncompliance with toxicity testing procedures including equipment requirements,
chain of custody procedures, quality control procedures, standard operating
procedures, recordkeeping and data reporting procedures;
10.N.J.A.C. 7:18-8, noncompliance with
requirements for performing analyze-immediately measurements;
11.N.J.A.C. 7:18-9, noncompliance with criteria
for sample handling and preservation, collection procedures and chain of custody
procedures;
12.
7:18-2.13(b)
,
(c), (d), (e), (f), (g), (h), and (i)3, failure to maintain records of PT samples;
13.
7:18-4.6(a), (b) and
(d), failure to maintain records as
required;
14.
7:18-5.6(a) and (b),
failure to maintain records as required;
15.
7:18-6.7(a), (b) and
(d), failure to maintain records as
required;
16.
7:18-7.7(b) and (h)1,
failure to maintain records as required; and
17.
7:18-8.5(a) and (b),
failure to maintain records as required.
(c) "Major violation" means a violation involving
the analysis of samples for the purpose of establishing compliance with a regulatory
program by a laboratory that is not a certified environmental laboratory; a
violation involving the analysis of samples for the purpose of establishing
compliance with a regulatory program, in a manner that is beyond the scope of a
laboratory's certification and ACPL; or a violation involving the falsification of
records. Violations of specific provisions of this chapter that are defined as major
violations include, but are not necessarily limited to:
1.
7:18-1.4(c) and
2.2(b), performance of analyses or test methods beyond the purview of a
certification;
2.
7:18-1.9(a), false
certification of information by the laboratory;
3.
7:18-2.2(a),
noncompliance with prohibition against noncertified laboratories analyzing samples
to establish compliance with a regulatory program;
4.
7:18-2.2(c),
misrepresentation of certification;
5.
7:18-2.6(c)3, failure
to cease compliance sampling and analyses activities governed by this chapter or the
statutes pursuant to which this chapter is promulgated upon the expiration or
termination of temporary approval;
6.
7:18-2.12(a)1, offering
to perform services beyond the scope of the laboratory's certification;
7.
7:18-2.14(a), denial of
access by Department personnel for audit purposes; and
8.
7:18-2.22(a), 4.3(a),
5.3(a), 6.4(a), 8.3(a), performance of analyses beyond the scope of certification;
and
9.
7:18-2.22(b)3,
misrepresentations made to persons other than the Department involving the
laboratory's status as a certified environmental laboratory.
