BPC 1265. (e) (1) A license or registration shall be valid for one year unless revoked or suspended. A clinical laboratory license or registration shall be automatically revoked 30 days from a major change of laboratory directorship or ownership. The clinical laboratory shall be required to submit a completed application for a new clinical laboratory license or registration within those 30 days or cease engaging in clinical laboratory practice.
(2) If a clinical laboratory intends to continue to engage in clinical laboratory practice during the 30 days after a major change in directorship occurs and before the laboratory license or registration is automatically revoked, the laboratory owner may appoint an interim director who meets the requirements of this chapter and CLIA. The interim director shall be appointed within five business days of the major change of the directorship. Written notice shall be provided to the department of the appointment of the laboratory director pursuant to this paragraph within five business days of the appointment.
(g) The department shall be notified in writing by the laboratory owners or delegated representatives of the owners and the laboratory directors of any change in ownership, directorship, name, or location, including the addition or deletion of laboratory owners or laboratory directors within 30 days. However, notice of change in ownership shall be the responsibility of both the current and new owners. Laboratory owners and directors to whom the current license or registration is issued shall remain jointly and severally responsible to the department for the operation, maintenance, and conduct of the clinical laboratory and for any violations of this chapter or the regulations adopted thereunder, including any failure to provide the notifications required by this subdivision, until proper notice is received by the department. In addition, failure of the laboratory owners and directors to notify the department within 30 days of any change in laboratory directors, including any additions or deletions, shall result in the automatic revocation of the clinical laboratory’s license or registration.
(a) As used in this chapter, "owner" means any person with an ownership or control interest in a clinical laboratory.
(b) "Person with an ownership or control interest" means a person, partnership, or corporation that meets any of the following descriptions:
(1) Has an ownership interest totaling 5 percent or more in a clinical laboratory.
(2) Has an indirect ownership interest equal to 5 percent or more in a clinical laboratory.
(3) Has a combination of direct and indirect ownership interests equal to 5 percent or more in a clinical laboratory.
(4) Owns an interest of 5 percent or more in any mortgage, deed of trust, note, or other obligation secured by the clinical laboratory if that interest equals at least 5 percent of the value of the property or assets of the clinical laboratory.
(5) Is an officer or director of a clinical laboratory that is organized as a corporation.
(6) Is a partner in a clinical laboratory that is organized as a partnership with no more than 25 partners, general or limited.
(7) Is a partner who exercises any operational or managerial control over a clinical laboratory organized as a partnership with more than 25 partners, general or limited.
(c) As used in this chapter "ownership interest" means the possession of equity in capital, stock, or profits.
(d) "Indirect ownership interest" means an ownership interest in an entity that has an ownership interest in a clinical laboratory, and includes an ownership interest in any entity that has an indirect ownership interest in a clinical laboratory.
(e) "Change in ownership" means any change in the persons who are owners.
(f) "Major change in ownership" means a change in ownership where 50 percent or more of the ownership interest is owned by persons other than the owners to whom the current clinical laboratory license or registration is issued.
(g) "Change in name" means any change in the name under which the laboratory operates or is doing business.
(h) "Change in location" means any change in the street and city address, or the site or place within the street and city address, for which a license or registration is issued.
(i) "Change in laboratory director" means any change in the laboratory director or directors to whom the current license or registration is issued.
(j) "Major change in laboratory directorship" means a change in laboratory director or directors resulting in the situation where less than 50 percent of the laboratory directors to whom the current laboratory license or registration is issued remain after the change.
(k) For purposes of this section, in the case of a pharmacy that applies for a registration pursuant to Section 1206.6, "laboratory director" means the pharmacist-in-charge identified pursuant to subdivision (a) of Section 1206.6.
(Amended by Stats. 2012, Ch. 874, Sec. 3. (SB 1481) Effective January 1, 2013.)