1. (a) The training or experience obtained by an applicant for licensure in a clinical laboratory located outside the United States that is not certified under CLIA meets licensure standards if the applicant can document that:

   1. (1) The laboratory is certified to meet International Organization for Standardization (ISO) 15189 and International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025 standards or later standards by an international accrediting organization that meets ISO/IEC 17011 standards or later standards for certifying technical facilities including clinical laboratories; and
   2. (2) The laboratory performs tests or examinations categorized as high complexity under CLIA in the specialty or subspecialty of training; and
   3. (3) The tests or examinations performed while obtaining the training or experience were performed on human biological specimens for diagnostic or clinical purposes, and not for academic, research, forensic, pharmaceutical, or veterinary purposes; and
   4. (4) The training or experience is acceptable for admission to a board certification examination approved by the Department for licensure in the specialty or subspecialty of training.

2. (b) The applicant for licensure must provide documentation of training or experience in a laboratory not certified under CLIA with a letter signed and sent directly to the Department by the laboratory director or medical director of the laboratory. This documentation must include the following information:

   1. (1) Name and address of the laboratory and its affiliation with a university, if applicable; and
   2. (2) International or national accreditation held by the laboratory; and
   3. (3) Name and qualifications of the laboratory or medical director; and
   4. (4) Specialty or subspecialty of tests or examinations performed by the laboratory and number of tests or examinations performed annually; and
   5. (5) Dates training or experience began and ended; and
   6. (6) Title and responsibilities or job assignments of the applicant while in training or employed; and
   7. (7) Tests or examinations performed by the applicant while in training or employed; and
   8. (8) Signature of the laboratory director or medical director and date of signature.

Note: Authority cited: Section 1224, Business and Professions Code; and Sections 100275 and 131200, Health and Safety Code. Reference: Sections 1206.5, 1208, 1209, 1210, 1260.3 and 1261, Business and Professions Code.

History

1. New section filed 11-13-2024; operative 1-1-2025 (Register 2024, No. 46). For prior history, see Register 2022, No. 40