[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: 42CFR493.51]

[Page 973]
 
                         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]