[Code of Federal Regulations]

[Title 42, Volume 4]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR493.5]



[Page 984]

 

                         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]



[[Page 985]]