§ 3.104 Secretarial actions.

(a) Actions in response to certification submissions for initial and continued listing as a PSO. (1) In response to an initial or continued certification submission by an entity, pursuant to the requirements of § 3.102 of this subpart, the Secretary may—

(i) Accept the certification submission and list the entity as a PSO, or maintain the listing of a PSO, if the Secretary determines that the entity meets the applicable requirements of the Patient Safety Act and this subpart;

(ii) Deny acceptance of a certification submission and, in the case of a currently listed PSO, remove the entity from the list if the entity does not meet the applicable requirements of the Patient Safety Act and this subpart; or

(iii) Condition the listing of an entity or the continued listing of a PSO, following a determination made pursuant to paragraph (c) of this section or a determination after review of the pertinent history of an entity that has been delisted or refused listing and its officials and senior managers.

(2) Basis for determination. In making a determination regarding listing, the Secretary will consider the certification submission; any prior actions by the Secretary regarding the entity or PSO including delisting; any history of or current non-compliance by the entity or the PSO or its officials or senior managers with statutory or regulatory requirements or requests from the Secretary; the relationships of the entity or PSO with providers; and any findings made by the Secretary in accordance with paragraph (c) of this section.