N.J. Admin. Code § 7:18-10.4

Current through Register Vol. 56, No. 24, December 18, 2024

Section 7:18-10.4 - Classes of violations

(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.N.J.A.C. 7:18-1.4(e), failure to display certification;

2.N.J.A.C. 7:18-2.11, noncompliance with requirements relating to managerial and supervisory duties;

3.N.J.A.C. 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.N.J.A.C. 7:18-2.14(c), failure to notify the Department of a change in the location of the laboratory;

5.N.J.A.C. 7:18-2.14(g), failure to notify the Department of the completion of corrective action;

6.N.J.A.C. 7:18-2.19(a), failure to report personnel changes;

7.N.J.A.C. 7:18-2.22(b)1, failure to obtain required written statements and disclaimers; and

8.N.J.A.C. 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.N.J.A.C. 7:18-2.10, noncompliance with laboratory personnel qualification requirements;

2.N.J.A.C. 7:18-2.14(f), failure to submit a corrective action plan in response to an audit within the time period provided;

3.N.J.A.C. 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.N.J.A.C. 7:18-2.12(b), failure to follow requirements and criteria in approved method, or N.J.A.C. 7:18-2.22(a), 4.3(a), 5.3(a), 6.4(a), 8.3(a), use of unapproved methods;

5.N.J.A.C. 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.N.J.A.C. 7:18-2.13(b), (c), (d), (e), (f), (g), (h), and (i)3, failure to maintain records of PT samples;

13.N.J.A.C. 7:18-4.6(a), (b) and (d), failure to maintain records as required;

14.N.J.A.C. 7:18-5.6(a) and (b), failure to maintain records as required;

15.N.J.A.C. 7:18-6.7(a), (b) and (d), failure to maintain records as required;

16.N.J.A.C. 7:18-7.7(b) and (h)1, failure to maintain records as required; and

17.N.J.A.C. 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.N.J.A.C. 7:18-1.4(c) and 2.2(b), performance of analyses or test methods beyond the purview of a certification;

2.N.J.A.C. 7:18-1.9(a), false certification of information by the laboratory;

3.N.J.A.C. 7:18-2.2(a), noncompliance with prohibition against noncertified laboratories analyzing samples to establish compliance with a regulatory program;

4.N.J.A.C. 7:18-2.2(c), misrepresentation of certification;

5.N.J.A.C. 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.N.J.A.C. 7:18-2.12(a)1, offering to perform services beyond the scope of the laboratory's certification;

7.N.J.A.C. 7:18-2.14(a), denial of access by Department personnel for audit purposes; and

8.N.J.A.C. 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.N.J.A.C. 7:18-2.22(b)3, misrepresentations made to persons other than the Department involving the laboratory's status as a certified environmental laboratory.

N.J. Admin. Code § 7:18-10.4

Amended by 47 N.J.R. 782(a), effective 4/20/2015.