[Code of Federal Regulations]
[Title 12, Volume 1]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR493.35]

[Page 979-980]
 
                         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 B--Certificate of Waiver
 
Sec. 493.35  Application for a certificate of waiver.

    Source: 57 FR 7142, Feb. 28, 1992, unless otherwise noted.


    (a) Filing of application. Except as specified in paragraph (b) of 
this section, a laboratory performing only one or more waived tests 
listed in Sec. 493.15 must file a separate application for each 
laboratory location.
    (b) Exceptions. (1) Laboratories that are not at a fixed location, 
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

[[Page 980]]

the laboratory sites within the same physical location or street 
address.
    (c) Application format and contents. The application must--
    (1) Be made to HHS or its designee on a form or forms prescribed by 
HHS;
    (2) Be signed by an owner, or by an authorized representative of the 
laboratory who attests that the laboratory will be operated in 
accordance with requirements established by the Secretary under section 
353 of the PHS 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 the total number of test procedures and 
examinations performed annually (excluding tests the laboratory may run 
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 requirements. Laboratories that perform one or more 
waived tests listed in Sec. 493.15(c) and no other tests must meet the 
following conditions:
    (1) Make records available and submit reports to HHS as HHS may 
reasonably require to determine compliance with this section and Sec. 
493.15(e);
    (2) Agree to permit announced and unannounced inspections by HHS in 
accordance with subpart Q of this part under the following 
circumstances:
    (i) When HHS has substantive reason to believe that the laboratory 
is being operated in a manner that constitutes an imminent and serious 
risk to human health.
    (ii) To evaluate complaints from the public.
    (iii) On a random basis to determine whether the laboratory is 
performing tests not listed in Sec. 493.15.
    (iv) To collect information regarding the appropriateness of waiver 
of tests listed in Sec. 493.15.
    (e) Denial of application. If HHS determines that the application 
for a certificate of waiver is to be denied, HHS will--
    (1) Provide the laboratory with a written statement of the grounds 
on which the denial is based and an opportunity for appeal, in 
accordance with the procedures set forth in subpart R of this part;
    (2) Notify a laboratory that has its application for a certificate 
of waiver denied that it cannot operate as a laboratory under the PHS 
Act unless the denial is overturned at the conclusion of the 
administrative appeals process provided by subpart R; and
    (3) Notify the laboratory that it is not eligible for payment under 
the Medicare and Medicaid programs.

[57 FR 7142, Feb. 28, 1992, as amended at 58 FR 5222, Jan. 19, 1993; 60 
FR 20044, Apr. 24, 1995]