| (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.
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