Laboratory or Clinical Laboratory.

(1)

Be operated under a current, unrevoked and unsuspended clinical laboratory license or registration issued by the department pursuant to division 2, chapter 3, (commencing with section 1200) of the Business and Professions Code; or a current, unrevoked and unsuspended certificate of approval issued by the department pursuant to sections 1000-1003 inclusive of the Health and Safety Code; or be exempt from licensure and registration under Business and Professions Code section 1241 or 1244; and

(2)

Have a current, unrevoked and unsuspended, certificate appropriate for the type and complexity of clinical laboratory tests or examinations performed, issued pursuant to the federal Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 United States Code section 263a; P.L. 100-578 and its implementing regulations, 42, Code of Federal Regulations part 493. If the United States Department of Health and Human Services (HHS) exempts clinical laboratories, laboratories or public health laboratories licensed, registered or otherwise approved by the department from the requirements of CLIA pursuant to (p) of section 263a of title 42 of the United States Code and section 493.513 of title 42 of the Code of Federal Regulations, this subsection's requirements regarding a CLIA certificate shall not apply, but only to those clinical laboratories, laboratories or public health laboratories exempted by HHS and only for the period of such exemption.

(3)

If providing services to persons who are Medicare eligible, be certified or meet the requirements for certification under title XVIII of the Federal Social Security Act, and have elected to provide services under title XVIII, or

(4)

If providing services to persons who are not Medicare eligible, be certified or meet the requirements for certification under title XVIII of the Federal Social Security Act.