SECTION 218.24. Standards

(a) The minimum standards for conforming status are specified in §218.23 of this title (relating to National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish), and the U.S. Food and Drug Administration Shellfish Laboratory Evaluation Checklists. These specifications are available online at http://www.dshs.texas.gov/seafood and for review during normal business hours at the Seafood and Aquatic Life Unit, Department of State Health Services, 8407 Wall Street, Austin, Texas 78754.

(b) Each laboratory will be evaluated, at a minimum on the following factors:

(1) credentials and performance of staff;

(2) quality assurance plan;

(3) manuals of procedures;

(4) staff training program;

(5) corrective action for any deficiencies and nonconformities;

(6) performance on proficiency test samples;

(7) equipment;

(8) calibrations and standards;

(9) methodology;

(10) facilities;

(11) sample acceptance policies;

(12) sample tracking;

(13) record keeping;

(14) reporting; and

(15) interpretation of results.

(c) A laboratory must meet all minimum standards and pass an inspection at a minimum of every three years to maintain conforming status.

(d) Laboratory status is determined by the number and types of nonconformities found in the evaluation using the specifications in §218.23 of this title (relating to National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish), and the standardized criteria contained in the U.S. Food and Drug Administration Shellfish Laboratory Evaluation Checklists.

Source Note: The provisions of this §218.24 adopted to be effective December 22, 2020, 45 TexReg 9214