SECTION 252:307-5-4. Failure to comply

(a)   Any person or laboratory to whom this Chapter applies must comply with the requirements of this Chapter and the statutory requirements of 27A O.S. §2-3-501 et seq., §2-4-305(A) and OAC 252:4-7-15. Failure to apply for or receive any part of an accreditation does not negate the requirement to meet any applicable requirement. Failure to comply may result in denial of applications, administrative and monetary penalties, suspension, reduction in scope, revocation or denial of renewal in part or in whole of the accreditation of any laboratory, and civil and/or criminal prosecution. Failure to comply includes:

(1)   repeat or significant errors in analyses, erroneous reporting or evidence of professional or technical incompetence;

(2)   misrepresentation to others regarding the type and conditions of DEQ accreditation and the potential or actual reliance of others on such misrepresentation;

(3)   failure to perform any of the following:

(A)   to correct deficiencies, comply with a corrective action plan, or take other action required by the DEQ pursuant to these rules;

(B)   to participate in or produce acceptable results in required proficiency testing;

(C)   to cooperate with or allow on-site laboratory evaluations, assessments, or access to record

(D)   to notify or submit reports to the DEQ as required by this Chapter; or

(E)   to maintain required records on file.

(4)   submission of a proficiency testing sample to another laboratory for analysis, and reporting data received as its own;

(5)   collaboration with another laboratory or any other individual on PT sample results prior to submittal to DEQ or prior to the closing date of the study;

(6)   allowing persons other than qualified laboratory employees to perform and report results of accredited analytes;

(7)   making any false statement or representation in or omitting material information from any required application, analysis, or report;

(8)   when the primary accreditation body (Primary AB) suspends a laboratory; or

(9)   failure to pay fees when due.

(b)   The DEQ reserves the right to enforce against a secondary accredited laboratory if the Primary AB does not take action or during the Primary AB's enforcement action.

(c)   As a part of any administrative order issued to a laboratory found to have unacceptable practices, the laboratory may be required, at its own cost, to hire a third party NELAP assessor to conduct an extraordinary assessment. The third party assessor must send the report to DEQ, and results or recommendations from the assessment may be incorporated as requirements of the administrative order.

(d)   All information included and documented in an extraordinary assessment report is public information and is subject to the Oklahoma Open Records Act, 51 Oklahoma Statutes, Section 24A et seq.

(e)   Laboratory accreditation will not be suspended or revoked without the right to due process as addressed in OAC 252:4, Rules of Practice and Procedure.

[Source: Added at 32 Ok Reg 961, eff 9-15-15]