37.12.312    LICENSE

(1) In the case of a laboratory applying for a license for the first time, the department may grant a conditional license to a laboratory that:

(a) is in compliance with all requirements for licensure but has not yet analyzed a second PE sample or does not have records of historical performance; or

(b) does not comply with all of the requirements of this subchapter, but whose deficiencies do not affect the capability of the laboratory to perform valid analyses.

(2) Conditional licensure will be granted only after an on-site inspection and is in effect for one year or until full licensure is granted under provisions of ARM 37.12.311, whichever is earlier.

(3) In order for a laboratory applying for a chemistry license for the first time to upgrade from conditional licensure status to fully licensed status, it must perform analyses of a minimum of two PE samples over the course of a year that indicate at least two successful analyses of each analyte or interdependent analyte group and method for which they seek licensure to analyze, and undergo a second on-site inspection that shows full compliance with licensure standards.

(4) In order for a laboratory applying for a microbiology license for the first time to upgrade from conditional licensure status to fully licensed status, a microbiology laboratory must be in continual operation for one year, analyze and successfully pass at least two performance evaluation (PE) sets for each analyte and method, and undergo a second on-site inspection to verify that its methodologies and quality control meet the standards of this subchapter.

History: 50-1-202, MCA; IMP, 50-1-202, 75-6-106, MCA; NEW, 1999 MAR p. 291, Eff. 2/12/99; AMD, 2003 MAR p. 2442, Eff. 10/31/03; AMD, 2011 MAR p. 2286, Eff. 10/28/11.