[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: 42CFR493.55]



[Page 994]

 

                         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 



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





accreditation.



    (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.

    (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]