[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: 42CFR493.63]



[Page 996]

 

                         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 D_Certificate of Accreditation

 

Sec.  493.63  Notification requirements for laboratories issued a 



certificate of accreditation.



    Laboratories issued a certificate of accreditation must:

    (a) Notify HHS and the approved accreditation program within 30 days 

of any changes in--

    (1) Ownership;

    (2) Name;

    (3) Location; or

    (4) Director.

    (b) Notify the approved accreditation program no later than 6 months 

after performing any test or examination within a specialty or 

subspecialty area that is not included in the laboratory's 

accreditation, so that the accreditation organization can determine 

compliance and a new certificate of accreditation can be issued.

    (c) Notify the accreditation program no later than 6 months after of 

any deletions or changes in test methodologies for any test or 

examination included in a specialty or subspecialty, or both, for which 

the laboratory has been issued a certificate of accreditation.