SECTION 218.7. Withdrawal of Accreditation or Approval

(a) A laboratory that fails to meet requirements may be placed on provisionally accredited or approved status:

(1) by scoring outside the acceptable limits on a set of split samples;

(2) by having serious deficiencies at the time of an onsite inspection; or

(3) by failing to notify the department within 30 days of major changes which might impair analytical capability (personnel, equipment, or location).

(b) Failure on two consecutive split samples or failure to correct major deficiencies following an onsite inspection, within 60 days, may result in the withdrawal of accreditation or approval. Withdrawal of accreditation or approval shall remain in effect until measures are taken by the laboratory to attain compliance and an additional onsite inspection determines that the major deficiencies are corrected at a time that is agreeable for both parties.

(c) Accreditation or approval may be suspended or revoked immediately if the minimum standards of the U.S. Food and Drug Administration require suspension or revocation, or if continued operation of the laboratory will jeopardize public health.

(d) Accreditation or approval shall be revoked for a laboratory that submits as its own work the results for analysis of any split samples that was analyzed by a different laboratory. The laboratory may not reapply for accreditation or approval for a period of not less than three years.

Source Note: The provisions of this §218.7 adopted to be effective December 22, 2020, 45 TexReg 9214