[Code of Federal Regulations]
[Title 42, Volume 3]
[Revised as of October 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR493.553]

[Page 977-978]
 
                         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. 493.553  Approval process (application and reapplication) for accreditation organizations and State licensure programs.

    (a) Information required. An accreditation organization that applies 
or reapplies to CMS for deeming authority, or a State licensure program 
that applies or reapplies to CMS for exemption from CLIA program 
requirements of licensed or approved laboratories within the State, must 
provide the following information:
    (1) A detailed comparison of the individual accreditation, or 
licensure or approval requirements with the comparable condition-level 
requirements; that is, a crosswalk.
    (2) A detailed description of the inspection process, including the 
following:
    (i) Frequency of inspections.
    (ii) Copies of inspection forms.
    (iii) Instructions and guidelines.
    (iv) A description of the review and decision-making process of 
inspections.
    (v) A statement concerning whether inspections are announced or 
unannounced.
    (vi) A description of the steps taken to monitor the correction of 
deficiencies.
    (3) A description of the process for monitoring PT performance, 
including action to be taken in response to unsuccessful participation 
in a CMS-approved PT program.
    (4) Procedures for responding to and for the investigation of 
complaints against its laboratories.
    (5) A list of all its current laboratories and the expiration date 
of their accreditation or licensure, as applicable.
    (6) Procedures for making PT information available (under State 
confidentiality and disclosure requirements, if applicable) including 
explanatory information required to interpret PT results, on a 
reasonable basis, upon request of any person.
    (b) CMS action on an application or reapplication. If CMS receives 
an application or reapplication from an accreditation organization, or 
State licensure program, CMS takes the following actions:
    (1) CMS determines if additional information is necessary to make a 
determination for approval or denial of the application and notifies the 
accreditation organization or State to afford it an opportunity to 
provide the additional information.

[[Page 978]]

    (2) CMS may visit the accreditation organization or State licensure 
program offices to review and verify the policies and procedures 
represented in its application and other information, including, but not 
limited to, review and examination of documents and interviews with 
staff.
    (3) CMS notifies the accreditation organization or State licensure 
program indicating whether CMS approves or denies the request for 
deeming authority or exemption, respectively, and the rationale for any 
denial.
    (c) Duration of approval. CMS approval may not exceed 6 years.
    (d) Withdrawal of application. The accreditation organization or 
State licensure program may withdraw its application at any time before 
official notification, specified at Sec. 493.553(b)(3).