The following words and terms, when used in this subchapter, shall have the following meanings unless the context clearly indicates otherwise.
  (1) Conforming status--An official status granted by the department to a laboratory. The official status permits the analysis of shellfish samples in accordance with applicable rules based on the process outlined in this subchapter. Conforming status means that a laboratory has been found to be capable of correctly performing the analyses for which it is approved.
  (2) Critical nonconformity--A deviation of a laboratory requirement which has the highest likelihood of adversely affecting the quality of the analytical results.
  (3) Department--The Department of State Health Services.
  (4) Evaluation--A fact-finding process performed by the department in which information and observations are collected for the purpose of evaluating the laboratory's compliance with established standards. Evaluation includes an onsite inspection but can, under a certain circumstance, be conducted by desk audit.
  (5) Key nonconformity--A deviation of laboratory requirement that has a significant potential to adversely affect the quality of the analytical results.
  (6) Other nonconformity--A deviation of a laboratory requirement which does not normally compromise the quality of the analytical results, but generally serves to enhance the overall operation of the laboratory.

Source Note: The provisions of this §218.22 adopted to be effective December 22, 2020, 45 TexReg 9214