1. (a) If a laboratory is subject to an unscheduled audit that has resulted in a finding of non-compliance, the laboratory shall propose a corrective action plan and submit the plan to the director within 30 days from the date that the laboratory receives the audit results. If the laboratory has been notified that further testing is not approved, the plan should identify the date that the laboratory intends to reinstate approved testing.

2. (b) A proposed corrective action plan under this section must fully address each non-compliance finding and identify corrective action that meets or exceeds the standards:

   1. (1) required by the laboratory's recognized accrediting body; and
   2. (2) approved by the director.

3. (c) The director shall promptly review a proposed corrective action plan and take the following action:

   1. (1) approve the corrective plan if it meets the requirements of this section; or
   2. (2) decline to approve the corrective plan and identify necessary revisions to the plan.
4. (d) The director shall notify the laboratory of approval or disapproval of the audit response. If disapproved, the director shall notify the laboratory of required corrective action, and the laboratory shall implement the corrective action in a timely manner specified in the notification, except as provided by subsection (e) of this section.
5. (e) A laboratory shall 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 director 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.