If the department determines that a laboratory that has been issued a license or registration under this chapter, except for a laboratory only performing tests or examinations classified as waived under CLIA, no longer substantially meets the requirements of this chapter or the regulations adopted thereunder, the department, in lieu of, or in addition to, revocation or suspension of the license or registration under Section 1320 or 1323, may impose any of the following:
(a) Directed plans of correction, as defined under CLIA.
(b) Civil money penalties in an amount ranging from fifty dollars ($50) to three thousand dollars ($3,000) per day of noncompliance, or per violation, for a condition-level deficiency that does not pose immediate jeopardy, to an amount ranging from three thousand fifty dollars ($3,050) to ten thousand dollars ($10,000) per day of noncompliance, or per violation, for a condition-level deficiency that poses immediate jeopardy, but only after notice and an opportunity to respond in accordance with Section 100171 of the Health and Safety Code, and consideration of facts enumerated in CLIA in Section 493.1834 of Title 42 of the Code of Federal Regulations.
(c) Civil money penalties in an amount ranging from fifty dollars ($50) to three thousand dollars ($3,000) per day of noncompliance, or per violation, for a violation of subdivision (t) of Section 1320, for failure to comply with disease reporting requirements, but only after notice and an opportunity to respond in accordance with Section 100171 of the Health and Safety Code.
(d) Onsite monitoring, as defined under CLIA, and payment for the costs of onsite monitoring.
(e) Any combination of the actions described in subdivisions (a), (b), (c), and (d).
(Amended by Stats. 2005, Ch. 219, Sec. 1. Effective January 1, 2006.)
Last modified: October 25, 2018