SECTIONS 1310-1311 - California Statutes

BUSINESS AND PROFESSIONS CODE

SECTION 1310-1311

1310. 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).

1311. 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.