Code of Federal Regulations Title 42. Public Health § 42.493.55 Application for registration certificate and certificate of accreditation

(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.

(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.

(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—