Cal. Code Regs. tit. 17 § 1067.5

Current through Register 2024 Notice Reg. No. 24, June 14, 2024

Section 1067.5 - Procedures for the Imposition of Civil Money Penalties

(a) The department may impose civil money penalties as an alternative sanction for any clinical laboratory that has condition level deficiencies.

(b) If the department is imposing civil money penalties, the following procedures apply:

(1) In determining the amount of the penalty, the department shall take into account the following factors:

(A) The nature, scope, severity, and duration of the deficiency or noncompliance.

(B) Whether the same condition level deficiencies have been identified during prior inspections.

(C) The laboratory's intent or reason for noncompliance.

(D) The accuracy and extent of laboratory records and their availability to the department or its contractors or agents.

(2) For a condition level deficiency that does not pose immediate jeopardy, the range of the penalty amount shall be $50-$3,000 per day of noncompliance or per violation. The department may, before any hearing, propose to increase the penalty amount into the range specified in (b)(3) for a laboratory that has deficiencies which, after imposition of a lower penalty amount, become sufficiently serious to pose immediate jeopardy.

(3) For a condition level deficiency that poses immediate jeopardy, the range of the penalty shall be $3,050-$10,000 per day of noncompliance or per violation. If the immediate jeopardy is removed, but the deficiency continues, the department shall shift the penalty amount to the range specified in (b)(2).

(4) The department shall send the laboratory written notice of intent to impose a civil money penalty. The notice shall include the following information:

(A) The statutory basis for the penalty,

(B) The proposed daily or per violation amount of the penalty,

(C) The factors (as described in paragraph (b)(1) of this section) that the department considered, and

(D) The time allowed for the laboratory to respond to the notice. (During the period specified, the laboratory may submit to the department written evidence or other information against the imposition of the proposed sanction or sanctions.)

(5) After the period specified in (b)(4)(D) has elapsed, the department shall give the laboratory a written Notice of Sanction that acknowledges any evidence or information received from the laboratory and specifies the following:

(A) The sanction or sanctions to be imposed against the laboratory,

(B) The authority and rationale for imposing the sanction or sanctions,

(C) The effective date and duration of sanction, and

(D) A specific statement regarding the laboratory's appeal rights and a Notice of Defense in the following form: Unless a written request for a hearing signed by the laboratory owner(s) or director(s) is delivered or mailed to the department within 15 days after the Notice of Sanction was mailed, the department may proceed upon imposition of the sanctions identified in the Notice of Sanction without a hearing. A request for a hearing may be made by delivering or mailing the enclosed form entitled Notice of Defense, or by delivering or mailing a notice of defense as provided by section 11506 of the Government Code to: The Department of Health Services at the address noted on the Notice of Sanction. The laboratory may, but need not, be represented by counsel at any or all stages of the proceedings.

(6) The laboratory shall have 15 days from the date of receipt of the Notice of Sanction to request a hearing by delivering or mailing a Notice of Defense. Hearings shall be conducted in accordance with chapter 5 (commencing with section 11500) of part 1 of division 3 of title 2 of the Government Code, except that hearings may be conducted by departmental hearing officers appointed by the director.

(7) The effective date of an alternative sanction of a civil money penalty shall be delayed if the laboratory has appealed and the hearing or the hearing decision is pending.

Cal. Code Regs. Tit. 17, § 1067.5

1. New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.
2. Certificate of Compliance as to 8-28-98 order, including amendment of subsection (b)(4)(D), transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Stats. 1995, c.510, Section 1. Reference: Stats.1995, c.510, Section 1; Section 1310, Business and Professions Code; and Section 11505, Government Code.