Section 18.78.815. Change in laboratory status.

	(a)  If the department receives a written complaint about a laboratory's performance, the department will, in its discretion, review that laboratory's work product, submittals to the department, and the results of any investigation conducted under (e) of this section. If, based on a review under this section, the department determines action is warranted, the department will  
		(1) downgrade the laboratory to provisionally approval status; or  
		(2) suspend or revoke approval, or provisional approval, subject to 18 AAC 78.960.  
	(b)  The department will downgrade a laboratory's status because of an unsatisfactory PE, as follows:  
		(1) if a laboratory with provisionally approved status fails a PE, the department will revoke the provisional approval and downgrade the laboratory to disapproved status;  
		(2) if an approved laboratory fails a PE, the laboratory manager shall submit to the department a corrective action report within 30 days after receiving notice of the failure; if the department  
			(A) approves the corrective action report, the department will maintain the laboratory's approved status; within six months, the laboratory manager shall ensure that a PE sample of the analyte for which the previous analysis was unacceptable is reanalyzed; if the laboratory  
				(i) fails the follow-up PE, the department will revoke the laboratory's approval and downgrade the laboratory to disapproved status; or  
				(ii) passes the follow-up PE, the department will maintain the laboratory's approved status; or  
			(B) does not approve the corrective action report, the department will place the laboratory on provisionally approved status.  
	(c)  The following are grounds for suspension or revocation of approval or of provisionally approved status;  
		(1) violating or failing to meet a requirement applicable to the operation of a laboratory under this chapter;  
		(2) misrepresenting a laboratory's qualifications, capabilities, or experience;  
		(3) falsifying data or a report;  
		(4) engaging in unethical or fraudulent practices in generating analytical data;  
		(5) failing an onsite investigation under (e) of this section;  
		(6) operating under significant deficiencies in quality assurance as evidence by the production of invalid analytical data or otherwise being unable to provide accurate analytical data using approved methods.  
	(d)  In addition to the grounds for suspension or revocation of approval stated in (c) of this section, the department will suspend or revoke the approval or provisionally approved status of a laboratory that is principally owned, operated, or controlled by an entity that has been suspended or otherwise restricted in its laboratory operation by a federal agency or by an agency of this state or another state, if the suspension or revocation is based on grounds listed in (c)(2) - (4) of this section or on significant deficiencies in quality assurance.  
	(e)  If available information indicates that an approved or provisionally approved laboratory is frequently submitting erroneous data or is otherwise not performing according to the requirements of 18 AAC 78.800, the department will, in its discretion, conduct an onsite investigation of the laboratory. The department will charge the laboratory $73 per hour for costs of the investigation, including development of the report that describes each area of noncompliance.  
	(f)  The department will maintain a list of approved and provisionally approved laboratories and will distribute the list to interested persons upon request.  

Authorities

44.46.020;44.46.025;46.03.020;46.03.365

Notes

Reference

18 AAC 75.355
18 AAC 78.271
18 AAC 78.275
18 AAC 78.800
18 AAC 78.810

Authority

AS 44.46.020 AS 44.46.025 AS 46.03.020 AS 46.03.365 ________________________

History

Eff. 1/22/99, Register 149