Section § 1310

Explanation

This law says that if a laboratory, except for those performing certain simple tests, fails to meet legal standards, the state can take various actions. Instead of or alongside taking away its license, the state might require a corrective action plan, impose daily fines depending on the severity of the problem, or enforce disease reporting rules. They might even send someone to monitor the lab and charge the lab for this. These measures can be combined in various ways, depending on the situation.

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)CA Business & Professions Code § 1310(a) Directed plans of correction, as defined under CLIA.
(b)CA Business & Professions Code § 1310(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)CA Business & Professions Code § 1310(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)CA Business & Professions Code § 1310(d) Onsite monitoring, as defined under CLIA, and payment for the costs of onsite monitoring.
(e)CA Business & Professions Code § 1310(e) Any combination of the actions described in subdivisions (a), (b), (c), and (d).

Section § 1311

Explanation

If a law or regulation under this chapter is violated, the department has a three-year window from the date of the violation to start legal or administrative proceedings.

The department shall have three years from the date of a violation of this chapter or of a regulation adopted thereunder to file a civil or administrative action.