Cal. Code Regs. tit. 17 § 1067

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

Section 1067 - Procedures for the Imposition of Directed Plans of Correction

(a) The department may impose a directed plan of correction as an alternative sanction for any clinical laboratory that has condition level deficiencies.

(b) If the department is imposing a directed plan of correction, the following procedures shall apply:

(1) The department shall give the laboratory a written Notice of Intent to impose a directed plan of correction. The Notice of Intent shall include the following:

(A) The condition level deficiency that has been identified,

(B) The sanction or sanctions that the department proposes to impose against the laboratory,

(C) The rationale for the proposed sanction or sanctions,

(D) The projected effective date and duration of the proposed sanction or sanctions,

(E) The authority for the proposed sanction or sanctions, and

(F) 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.)

(2) After the period specified in (b)(1)(F) has elapsed, the department shall give the laboratory a written Notice of Sanction to impose a Directed Plan of Correction 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 direction to the laboratory to take specific corrective action within specific time frames in order to achieve compliance.

Cal. Code Regs. Tit. 17, § 1067

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 A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.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)(1)(F), 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 Sections 11503, 11505 and 11506, Government Code.