[Code of Federal Regulations]
[Title 12, Volume 1]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR493.559]

[Page 991]
 
                         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 E--Accreditation by a Private, Nonprofit Accreditation 
  Organization or Exemption Under an Approved State Laboratory Program
 
Sec. 493.559  Publication of approval of deeming authority or CLIA exemption.

    (a) Notice of deeming authority or exemption. CMS publishes a notice 
in the Federal Register when it grants deeming authority to an 
accreditation organization or exemption to a State licensure program.
    (b) Contents of notice. The notice includes the following:
    (1) The name of the accreditation organization or State licensure 
program.
    (2) For an accreditation organization:
    (i) The specific specialty or subspecialty areas for which it is 
granted deeming authority.
    (ii) A description of how the accreditation organization provides 
reasonable assurance to CMS that a laboratory accredited by the 
organization meets CLIA requirements equivalent to those in this part 
and would meet CLIA requirements if the laboratory had not been granted 
deemed status, but had been inspected against condition-level 
requirements.
    (3) For a State licensure program, a description of how the 
laboratory requirements of the State are equal to, or more stringent 
than, those specified in this part.
    (4) The basis for granting deeming authority or exemption.
    (5) The term of approval, not to exceed 6 years.

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