SECTION 651.103. Corrective Action Plan

(a) If a laboratory is subject to an audit that resulted in a determination that corrective action is needed, the laboratory shall propose a corrective action plan and submit the plan to the Commission within 30 days from the date the laboratory receives the subject matter expert's report.

(b) A proposed corrective action plan under this section must fully address each adverse finding and identify appropriate corrective action.

(c) The Commission must promptly review a proposed corrective action plan and take the following action:

(1) approve the corrective action plan; or

(2) decline to approve the corrective plan and identify necessary revisions to the plan.

(d) The Commission must notify the laboratory in writing of approval or disapproval of the audit response. If not approved, the Commission must notify the laboratory of required corrective action, and the laboratory must implement the corrective action in a timely manner specified in the notification, except as provided by subsection (e) of this section.

(e) A laboratory must implement and complete an approved corrective action plan described in subsection (d) of this section, unless the laboratory demonstrates good cause for extension to the Commission before the due date for completion.

Source Note: The provisions of this §651.103 adopted to be effective June 1, 2010, 35 TexReg 4439; transferred effective September 1, 2015, as published in the Texas Register October 9, 2015, 40 TexReg 7109; amended to be effective December 24, 2015, 40 TexReg 9305; amended to be effective August 26, 2020, 45 TexReg 5930; amended to be effective February 25, 2024, 49 TexReg 877