[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: 42CFR493.553]



[Page 997-998]

 

                         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.



[[Page 998]]



    (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.

    (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).