[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: 42CFR493.51]



[Page 993]

 

                         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 C_Registration Certificate, Certificate for Provider-performed 

          Microscopy Procedures, and Certificate of Compliance

 

Sec.  493.51  Notification requirements for laboratories issued a certificate 



of compliance.



    Laboratories issued a certificate of compliance must meet the 

following conditions:

    (a) Notify HHS or its designee within 30 days of any change in--

    (1) Ownership;

    (2) Name;

    (3) Location;

    (4) Director; or

    (5) Technical supervisor (laboratories performing high complexity 

only).

    (b) Notify HHS no later than 6 months after performing any test or 

examination within a specialty or subspecialty area that is not included 

on the laboratory's certificate of compliance, so that compliance with 

requirements can be determined.

    (c) Notify HHS no later than 6 months after 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 compliance.



[57 FR 7143, Feb. 28, 1992, as amended at 60 FR 20046, Apr. 24, 1995]