(a) In order to carry out the purpose of this article, any duly authorized representative of the state board may do the following:
(1) Enter and inspect a laboratory that is ELAP certified or TNI accredited pursuant to this article or that has applied for ELAP certification or TNI accreditation.
(2) Inspect and photograph any portion of the laboratory, equipment, any activity, or any samples taken, or copy and photograph any records, reports, test results, or other information related solely to certification under this article or regulations adopted pursuant to this article.
(3) Require an owner of a laboratory to provide, within 15 days of receiving a request from a duly authorized representative of the state board, reports, test results, and other information required to implement this article, including, but not limited to, applicable standard operating procedures, quality control or quality assurance manuals, quality control or quality assurance data, employee qualifications, training records, or information relating to accreditation with another state or agency. The state board may require a laboratory to conduct proficiency testing in any of the laboratory’s accredited fields of testing.
(b) It shall be a misdemeanor for any person to prevent, interfere with, or attempt to impede in any way, any duly authorized representative of the state board from undertaking the activities authorized by this section.
(c) If a laboratory that is seeking ELAP certification, TNI accreditation, ELAP recertification, or TNI reaccreditation refuses entry of a duly authorized representative during normal business hours for either an announced or unannounced onsite assessment, the certification, accreditation, recertification, or reaccreditation shall be denied or revoked.
(d) Refusal of a request by a TNI approved accrediting authority, the state board, or any employee, agent, or contractor of the state board, for permission to inspect, pursuant to this section, the laboratory and its operations and pertinent records during the hours the laboratory is in operation shall result in denial or revocation of ELAP certification or TNI accreditation.
(Amended by Stats. 2017, Ch. 327, Sec. 12. (AB 1438) Effective January 1, 2018.)
Last modified: October 25, 2018