Section 18 AAC 78.815 - Change in laboratory status(a) The department will place an approved laboratory in provisionally approved status if the department finds that the laboratory manager has provided inaccurate information in the laboratory's application for approval, unless the grounds listed in (b) or (c) of this section apply. The department may place the laboratory in approved status once accurate information is supplied.(b) Subject to 18 AAC 78.960, the department will revoke a laboratory's approved or provisionally approved status for all analytes, methods, and matrices if the laboratory manager is found to have (1) failed to notify the department of a change in the laboratory's certification status under a NELAP or DoD-ELAP accreditation body not later than three working days after the change; (2) deliberately misrepresented a laboratory's qualifications, capabilities, or(3) falsified data or a report;(4) engaged in unethical or fraudulent practices in generating analytical data;(5) failed to disclose required information in the application submitted under 18 AAC 78.800; or(6) operated the laboratory under significant deficiencies in quality assurance as evidenced by the production of invalid analytical data or was otherwise not able to provide accurate analytical data using approved methods.(c) Subject to 18 AAC 78.960, and in addition to the grounds under (b) of this section for revocation of approved or provisionally approved status, the department will revoke the approved or provisionally approved status of a laboratory that is principally owned, operated, or controlled by an entity that has been suspended, revoked, or otherwise restricted in its laboratory operation by a federal agency or by an agency of this state or another state, if the suspension, revocation, or restriction is based on grounds listed in (b)(2) - (6) of this section or on significant deficiencies in quality assurance.(d) The department will conduct periodic reviews of the approved and provisionally approved laboratories on the list it maintains to verify that information provided to the department concerning the status of each laboratory is accurate and current.(e) If under (b) or (c) of this section the department revokes a laboratory's approved or provisionally approved status, the laboratory may not re-apply for approval for at least 12 months from the date of revocation. Eff. 1/22/99, Register 149; am 7/1/2017,Register 222, July 2017Authority:AS 44.46.020
AS 44.46.025
AS 46.03.020
AS 46.03.365