[Code of Federal Regulations]
[Title 42, Volume 3]
[Revised as of October 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR493.573]

[Page 994-995]
 
                         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.

[[Page 995]]

    (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.