(a) As used in this chapter, âownerâ means any person with an ownership or control interest in a clinical laboratory. (b) âPerson with an ownership or control interestâ 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 âownership interestâ means the possession of equity in capital, stock, or profits. (d) âIndirect ownership interestâ 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) âChange in ownershipâ means any change in the persons who are owners. (f) âMajor change in ownershipâ 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) âChange in nameâ means any change in the name under which the laboratory operates or is doing business. (h) âChange in locationâ 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) âChange in laboratory directorâ means any change in the laboratory director or directors to whom the current license or registration is issued. (j) âMajor change in laboratory directorshipâ 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, âlaboratory directorâ means the pharmacist-in-charge identified pursuant to subdivision (a) of Section 1206.6.
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