[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: 42CFR493.35]



[Page 988-989]

 

                         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 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;



[[Page 989]]



    (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]