42 CFR 493.5 : Public Health (Part 1 To Parts 1009-1099) — (§ 482.1 To Parts 1009-1099) — Centers For Medicare & Medicaid Services, Department Of Health And Human Services (Continued) (§ 482.1 To Parts 601-699) — Standards And Certification (§ 482.1 To § 498.103) — Laboratory Requirements (§ 493.1 To § 493.2001) — General Provisions (§ 493.1 To § 493.25) — Categories of tests by complexity.

(a) Laboratory tests are categorized as one of the following:

(1) Waived tests.

(2) Tests of moderate complexity, including the subcategory of PPM procedures.

(3) Tests of high complexity.

(b) A laboratory may perform only waived tests, only tests of moderate complexity, only PPM procedures, only tests of high complexity or any combination of these tests.

(c) Each laboratory must be either CLIA-exempt or possess one of the following CLIA certificates, as defined in § 493.2:

(1) Certificate of registration or registration certificate.

(2) Certificate of waiver.

(3) Certificate for PPM procedures.

(4) Certificate of compliance.

(5) Certificate of accreditation.