18 AAC 80.1105 - Onsite inspections

Current through April 6, 2022

(a) After the department issues a laboratory's initial certification under 18 AAC 80.1100(c), the laboratory must receive an initial onsite inspection from the department to review the laboratory's work product and quality control systems. A laboratory's initial certification will be classified as interim certification under 18 AAC 80.100(c)(2) until the laboratory receives and passes the initial onsite inspection.
(b) During the three-year period that starts on the date of its initial certification, and during each subsequent three-year period that starts on the day after the date of an inspection under this subsection or (c) of this section, a laboratory certified under 18 AAC 80.1100(b) and (c) must receive and pass, as a condition of maintaining certification, an onsite inspection to review the laboratory's work product and quality control systems. The inspection is in addition to the initial inspection required under (a) of this section. If a laboratory does not receive an onsite inspection in accordance with this subsection, and the laboratory qualifies for interim certification under 18 AAC 80.1100(c) (2), the laboratory's certification will be classified as interim certification until the laboratory receives and passes the inspection.
(c) Nothing in this section prevents the department from conducting, at any time under AS 46.03.020 and 46.03.860, an onsite inspection of a laboratory certified under 18 AAC 80.1100(b) and (c). The laboratory must pass the inspection as a condition of maintaining certification.
(d) If an inspection under this section indicates that the inspected laboratory is in compliance with all conditions for certification under 18 AAC 80.1100(c) (1)(A), the department will notify the laboratory in writing that it has passed the inspection.
(e) If an inspection under this section indicates that the inspected laboratory fails to maintain quality control standards as required under 18 AAC 80.1100(b) (2), or is otherwise deficient in a requirement for maintaining certification, the department will report the deficiencies to the laboratory in writing and provide an opportunity for response. Based on the results of the inspection and on the information supplied in the laboratory's response, if any, the department may revoke or downgrade certification under 18 AAC 80.1100(h).

Notes

18 AAC 80.1105
Eff. 10/1/99, Register 151; am 7/25/2010, Register 195

Authority:AS 46.03.020

AS 46.03.050

AS 46.03.710

AS 46.03.720

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