15A NCAC 02H .1106      DECERTIFICATION

(a)  The Director or the Director's designee may revoke the entire laboratory certification for:

(1)           failing to maintain the facilities, records, personnel, equipment, or a quality assurance program as required by these Rules;

(2)           submitting inaccurate or falsified data reports or other information; or

(3)           failing to pay required fees by the date due.

(b)  A laboratory certification may be revoked for a category for failure to:

(1)           obtain acceptable results on two consecutive proficiency testing samples. Acceptable results on proficiency testing samples are those that fall within the specified acceptable range as indicated by the State Laboratory or State Laboratory-approved vendor. The State Laboratory may apply specific variance or statistical limits or performance criteria on performance evaluation samples or split samples for a particular testing procedure, including control population effects and taxonomic identification, as published in these Rules;

(2)           obtain acceptable results as set out in Subparagraph (b)(1) of this Paragraph on two consecutive split samples that have also been analyzed by the Division;

(3)           submit a split sample to the Division as requested;

(4)           use approved procedures as defined in Rule .1103 of this Section;

(5)           report equipment changes that would affect the laboratory's ability to perform a test category to the State Laboratory within 30 days of the change;

(6)           report results of proficiency testing to the State Laboratory within the requirements that are set forth by the proficiency study;

(7)           maintain records and perform quality controls as set forth by these Rules;

(8)           maintain equipment required for any certified parameter;

(9)           implement and maintain quality control programs approved in conjunction with certification; or

(10)         maintain a qualified staff, as specified in Rule .1110(f)(1) and (2) of this Section.

(c)  Requirements for Laboratories following Decertification:

(1)           A laboratory shall not analyze samples for parameters in decertified categories for programs governed by rules of this Section.

(2)           A decertified commercial laboratory shall notify any clients affected by the laboratory's decertification and supply the State Laboratory with a list of those clients affected and a written certification that those clients have been notified. If the decertified laboratory arranges for a certified laboratory to perform analyses during the period of decertification, the decertified laboratory shall supply the Division with the name of the replacement laboratory and the clients involved. The name of the certified laboratory that performs analyses shall appear on all data submitted to the Division.

History Note:        Authority G.S. 143‑215.3(a)(1); 143-215.3(a)(4); 143‑215.3(a)(10); 143‑215.66;

Eff. October 1, 1988;

Amended Eff. March 1, 1993;

Readopted Eff. July 1, 2019.