[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: 42CFR493.559]



[Page 1000]

 

                         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.