| (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 |
