1VAC30-45-793. Microbiology testing: method evaluation.
A. Laboratories are required to demonstrate proficiency with the test method prior to first use. This shall be achieved by comparison to a method already approved for use in the laboratory, or by analyzing a minimum of 10 spiked samples whose quality system matrix is representative of those normally submitted to the laboratory, or by analyzing and passing one proficiency test series provided by an approved proficiency sample provider. The laboratory shall maintain this documentation as long as the method is in use and for at least five years past the date of last use.
B. Laboratories shall participate in the proficiency test programs required by Article 3 (1VAC30-45-500 et seq.). The results of these analyses shall be used to evaluate the ability of the laboratory to produce acceptable data.
Statutory Authority
§ 2.2-1105 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.