42 CFR § 493.35 - Application for a certificate of waiver.
(a) Filing of application. Except as specified in paragraph (b) of this section, a laboratory performing only one or more waived tests listed in § 493.15 must file a separate application for each laboratory location.
(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 -
(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
(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
(d) Access requirements. Laboratories that perform one or more waived tests listed in § 493.15(c) and no other tests must meet the following conditions:
(ii) To evaluate complaints from the public.
(iv) To collect information regarding the appropriateness of waiver of tests listed in § 493.15.
(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
The following state regulations pages link to this page.
- Alaska Admin. Code Title 7 § 110.100 - 7 AAC 110.100 - Advanced nurse practitioner enrollment requirements
- Alaska Admin. Code Title 7 § 110.400 - 7 AAC 110.400 - Physician services provider enrollment requirements