[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: 42CFR493.573]



[Page 1003]

 

                         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.  493.573  Continuing Federal oversight of private nonprofit 



accreditation organizations and approved State licensure programs.



    (a) Comparability review. In addition to the initial review for 

determining equivalency of specified organization or State requirements 

to the comparable condition-level requirements, CMS reviews the 

equivalency of requirements in the following cases:

    (1) When CMS promulgates new condition-level requirements.

    (2) When CMS identifies an accreditation organization or a State 

licensure program whose requirements are no longer equal to, or more 

stringent than, condition-level requirements.

    (3) When an accreditation organization or State licensure program 

adopts new requirements.

    (4) When an accreditation organization or State licensure program 

adopts changes to its inspection process, as required by Sec.  

493.575(b)(1), as applicable.

    (5) Every 6 years, or sooner if CMS determines an earlier review is 

required.

    (b) Validation review. Following the end of a validation review 

period, CMS evaluates the validation inspection results for each 

approved accreditation organization and State licensure program.

    (c) Reapplication procedures. (1) Every 6 years, or sooner, as 

determined by CMS, an approved accreditation organization must reapply 

for continued approval of deeming authority and a State licensure 

program must reapply for continued approval of a CLIA exemption. CMS 

provides notice of the materials that must be submitted as part of the 

reapplication procedure.

    (2) An accreditation organization or State licensure program that 

does not meet the requirements of this subpart, as determined through a 

comparability or validation review, must furnish CMS, upon request, with 

the reapplication materials CMS requests. CMS establishes a deadline by 

which the materials must be submitted.

    (d) Notice. (1) CMS provides written notice, as appropriate, to the 

following:

    (i) An accreditation organization indicating that its approval may 

be in jeopardy if a comparability or validation review reveals that it 

is not meeting the requirements of this subpart and CMS is initiating a 

review of the accreditation organization's deeming authority.

    (ii) A State licensure program indicating that its CLIA exemption 

may be in jeopardy if a comparability or validation review reveals that 

it is not meeting the requirements of this subpart and that a review is 

being initiated of the CLIA exemption of the State's laboratories.

    (2) The notice contains the following information:

    (i) A statement of the discrepancies that were found as well as 

other related documentation.

    (ii) An explanation of CMS's review process on which the final 

determination is based and a description of the possible actions, as 

specified in Sec.  493.575, that CMS may impose based on the findings 

from the comparability or validation review.

    (iii) A description of the procedures available if the accreditation 

organization or State licensure program, as applicable, desires an 

opportunity to explain or justify the findings made during the 

comparability or validation review.

    (iv) The reapplication materials that the accreditation organization 

or State licensure program must submit and the deadline for that 

submission.