SECTION 218.26. Withdrawal of Conforming Status

(a) A laboratory found to be in conforming status, with noted nonconformities, has up to 90 days to successfully correct all nonconformities noted in the evaluation. After this period, the laboratory's status will be downgraded to nonconforming if any key nonconformities remain to be successfully corrected. As a result, data being generated by the laboratory will no longer be acceptable for use in support of the National Shellfish Sanitation Program.

(b) A laboratory found to be in provisionally conforming status has up to 60 days to successfully correct all nonconformities noted in the evaluation. After this period, the laboratory's status will be assigned to one of the following.

(1) Conforming status if all critical and key nonconformities have been successfully corrected.

(2) Nonconforming status if any critical or key nonconformities remain to be successfully corrected. As a result, data generated by the laboratory will no longer be acceptable for use in support of the National Shellfish Sanitation Program.

(c) A laboratory found to be in nonconforming status has up to 30 days to demonstrate successful correction of all nonconformities found. After this period, the laboratory's status will be assigned to one of the following.

(1) Conforming status if all critical and key nonconformities have been successfully corrected.

(2) Nonconforming status if any critical or key nonconformities remain to be successfully corrected. As a result, data generated by the laboratory will no longer be acceptable for use in support of the National Shellfish Sanitation Program.

(d) If a laboratory is found to be in nonconforming status for failure to successfully implement the required corrective action, or for having repeated critical or key nonconformities in consecutive evaluations, then the department will ensure that an action plan is developed to correct the situation in an acceptable and expeditious manner or discontinue use of the laboratory to support the National Shellfish Sanitation Program.

Source Note: The provisions of this §218.26 adopted to be effective December 22, 2020, 45 TexReg 9214