[Code of Federal Regulations]
[Title 42, Volume 3]
[Revised as of October 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR493.5]

[Page 964]
 
                         TITLE 42--PUBLIC HEALTH
 
  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 
                 HEALTH AND HUMAN SERVICES--(Continued)
 
PART 493--LABORATORY REQUIREMENTS--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 493.5  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 Sec. 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.

[60 FR 20043, Apr. 24, 1995]