[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: 42CFR493.1]



[Page 979]

 

                         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.  493.1  Basis and scope.



    Source: 57 FR 7139, Feb. 28, 1992, unless otherwise noted.





    This part sets forth the conditions that all laboratories must meet 

to be certified to perform testing on human specimens under the Clinical 

Laboratory Improvement Amendments of 1988 (CLIA). It implements sections 

1861 (e) and (j), the sentence following section 1861(s)(13), and 

1902(a)(9) of the Social Security Act, and section 353 of the Public 

Health Service Act. This part applies to all laboratories as defined 

under ``laboratory'' in Sec.  493.2 of this part. This part also applies 

to laboratories seeking payment under the Medicare and Medicaid 

programs. The requirements are the same for Medicare approval as for 

CLIA certification.