North Carolina Administrative Code
Title 10A - HEALTH AND HUMAN SERVICES
Chapter 42 - LABORATORY SERVICES
Subchapter D - CERTIFICATION AND IMPROVEMENT
Section .0200 - LABORATORY CERTIFICATION
Section 42D .0234 - CRITERIA AND PROCEDURES: DECERT./DENIAL/DOWNGRADING

Universal Citation: 10A NC Admin Code 42D .0234

Current through Register Vol. 39, No. 6, September 16, 2024

(a) The State Laboratory of Public Health or its delegate may decertify, downgrade or deny laboratory certification if the laboratory:

(1) Failed to train or supervise employees in laboratory methodologies required by 15A NCAC 18C .1500;

(2) Failed to report analytical results of performance evaluation samples or compliance samples or maintain records as required by this Section and the Rules Governing Public Water Supplies in 15A NCAC 18C .1500;

(3) Failed to maintain facilities and equipment in accordance with the minimum requirements of this Section;

(4) Failed to notify the certification evaluator within 30 days of major changes such as personnel, equipment, or laboratory location;

(5) Violated or aided and abetted in the violation of any provisions of the rules of this Section; or

(6) Failed to correctly analyze on-site evaluation performance samples during the initial on-site evaluation.

(b) A downgraded laboratory with provisional certification may continue to perform analyses. The provisional status shall continue for at least six months. At the end of the six months the laboratory certification shall be reinstated if the laboratory has made corrections and is in compliance with the minimum requirements for certification. If no corrections have been made the laboratory certification may be revoked.

(c) The State Laboratory of Public Health or its delegate may decertify or deny laboratory certification when a laboratory or its employees have done any of the following:

(1) Knowingly made false statements on any documents associated with certification;

(2) Falsified results of analysis;

(3) Submitted performance evaluation samples used for certification determination to another laboratory for analysis;

(4) Failed to employ approved laboratory methodology in the performance of the analyses required by 15A NCAC 18C .1500;

(5) Failed to correctly analyze performance evaluation samples including United States EPA water study, double blind, blind, and on-site samples or report the results within the specified time in accordance with the requirements of 15A NCAC 20D .0243 and 20D .0251;

(6) Failed to report analytical results of performance evaluation samples or compliance samples or maintain records as required by this Section and the Rules Governing Public Water Supplies in 15A NCAC 18C;

(7) Failed to satisfy the certification evaluator that the laboratory has corrected deviations identified during the on-site visit within 30 days; or

(8) Violated or aided and abetted in the violation of any provisions of the rules of this Section.

(d) The State Laboratory of Public Health its delegate shall notify a laboratory of its intent to decertify, downgrade to provisional status or deny certification. The notice shall be in writing and include reasons for the decision and shall be delivered by certified mail.

(e) This Rule shall not preclude informal conferences concerning a decision to decertify, downgrade to provisional status or deny certification.

(f) If a laboratory is denied initial certification for failure to satisfy this Rule, the laboratory may request another evaluation which shall be scheduled between 15 days and 30 days after the initial on-site evaluation. If the laboratory is denied certification during the second on-site evaluation, the laboratory shall satisfy the initial certification criteria as stated in Rule .0232 of this Section before another evaluation is scheduled.

(g) The State Laboratory of Public Health or its delegate may decertify or deny laboratory certification if the laboratory has been decertified by another certifying agency for committing any of the items contained in Subparagraphs (c)(1)-(3) of this Rule.

Authority G.S. 130A-315;
Eff. December 1, 1991;
Amended Eff. January 1, 1996; October 1, 1994; May 1, 1993;
Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. December 23, 2017.

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