Section 149.32. Evaluation corrective action.

 

(1)  A laboratory shall take corrective action to address any deficiencies discovered during an on-site evaluation.

(2)  A laboratory shall submit to the department within 30 days from the evaluation report's date a plan of corrective action to address all the deficiencies noted in the report. When a laboratory finds it necessary to submit a corrective action plan at a date later than 30 days after the evaluation report's date, the laboratory shall notify the department about the delay and provide an expected delivery date in consultation with the department.

(3)  The department shall review the corrective action plan submitted by a laboratory and inform the laboratory whether the submitted plan addresses satisfactorily all noted deficiencies, or whether additional action or documentation is necessary to determine the laboratory's ability to comply with this chapter.

(a) When the department determines that the submitted corrective action plan addresses all noted deficiencies satisfactorily, the department shall inform the laboratory in writing within 180 days of the conclusion of on-site visit that the evaluation process has been completed.

(b) When the department determines that additional action or documentation is needed to evaluate compliance with this chapter, the department shall agree on a date for a second corrective action plan to be submitted in consultation with the laboratory.

1. When the department determines that the second corrective action plan addresses all noted deficiencies satisfactorily, the department shall inform the laboratory in writing that the evaluation process has concluded.

2. When the department determines that the second corrective action plan does not address all the noted deficiencies satisfactorily, the department may schedule another on-site evaluation to determine the laboratory's compliance with this chapter, terminate any outstanding application that led to the original on-site evaluation or direct enforcement to the laboratory.

3. When a second on-site evaluation is scheduled as a follow-up to a second corrective action plan, the department shall establish deadlines that resolve any remaining unresolved deficiencies expeditiously, but no later than 90 days after the conclusion of the follow-up visit.

History: CR 06-005 : cr. Register April 2008 No. 628 , eff. 9-1-08.