[Code of Federal Regulations]
[Title 42, Volume 3]
[Revised as of October 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR493.55]

[Page 985-986]
 
                         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. 493.55  Application for registration certificate and certificate of 
accreditation.

    Source: 57 FR 7144, Feb. 28, 1992, unless otherwise noted.


    (a) Filing of application. A laboratory may be issued a certificate 
of accreditation in lieu of the applicable certificate specified in 
subpart B or subpart C of this part provided the laboratory--
    (1) Meets the standards of a private non-profit accreditation 
program approved by HHS in accordance with subpart E; and
    (2) Files a separate application for each location, except as 
specified in paragraph (b) of this section.

[[Page 986]]

    (b) Exceptions. (1) Laboratories that are not at fixed locations, 
that is, laboratories that move from testing site to testing site, such 
as mobile units providing laboratory testing, health screening fairs, or 
other temporary testing locations may be covered under the certificate 
of the designated primary site or home base, using its address.
    (2) Not-for-profit or Federal, State, or local government 
laboratories that engage in limited (not more than a combination of 15 
moderately complex or waived tests per certificate) public health 
testing may file a single application.
    (3) Laboratories within a hospital that are located at contiguous 
buildings on the same campus and under common direction may file a 
single application or multiple applications for the laboratory sites 
within the same physical location or street address.
    (c) Application format and contents. The application must--(1) Be 
made to HHS on a form or forms prescribed by HHS;
    (2) Be signed by an owner or authorized representative of the 
laboratory who attests that the laboratory will be operated in 
accordance with the requirements established by the Secretary under 
section 353 of the Public Health Service Act; and
    (3) Describe the characteristics of the laboratory operation and the 
examinations and other test procedures performed by the laboratory 
including--
    (i) The name and total number of tests and examinations performed 
annually (excluding waived tests and tests for quality control, quality 
assurance or proficiency testing purposes);
    (ii) The methodologies for each laboratory test procedure or 
examination performed, or both; and
    (iii) The qualifications (educational background, training, and 
experience) of the personnel directing and supervising the laboratory 
and performing the laboratory examinations and test procedures.
    (d) Access and reporting requirements. All laboratories must make 
records available and submit reports to HHS as HHS may reasonably 
require to determine compliance with this section.

[57 FR 7144, Feb. 28, 1992, as amended at 58 FR 5224, Jan. 19, 1993; 58 
FR 39155, July 22, 1993; 60 FR 20046, Apr. 24, 1995]