Page:United States Statutes at Large Volume 119.djvu/450

 119 STAT. 432

PUBLIC LAW 109–41—JULY 29, 2005 ‘‘(B) The entity has appropriately qualified staff (whether directly or through contract), including licensed or certified medical professionals. ‘‘(C) The entity, within each 24-month period that begins after the date of the initial listing under subsection (d), has bona fide contracts, each of a reasonable period of time, with more than 1 provider for the purpose of receiving and reviewing patient safety work product. ‘‘(D) The entity is not, and is not a component of, a health insurance issuer (as defined in section 2791(b)(2)). ‘‘(E) The entity shall fully disclose— ‘‘(i) any financial, reporting, or contractual relationship between the entity and any provider that contracts with the entity; and ‘‘(ii) if applicable, the fact that the entity is not managed, controlled, and operated independently from any provider that contracts with the entity. ‘‘(F) To the extent practical and appropriate, the entity collects patient safety work product from providers in a standardized manner that permits valid comparisons of similar cases among similar providers. ‘‘(G) The utilization of patient safety work product for the purpose of providing direct feedback and assistance to providers to effectively minimize patient risk. ‘‘(2) ADDITIONAL CRITERIA FOR COMPONENT ORGANIZATIONS.—If an entity that seeks to be a patient safety organization is a component of another organization, the following are additional criteria for the initial and subsequent certification of the entity as a patient safety organization: ‘‘(A) The entity maintains patient safety work product separately from the rest of the organization, and establishes appropriate security measures to maintain the confidentiality of the patient safety work product. ‘‘(B) The entity does not make an unauthorized disclosure under this part of patient safety work product to the rest of the organization in breach of confidentiality. ‘‘(C) The mission of the entity does not create a conflict of interest with the rest of the organization. ‘‘(c) REVIEW OF CERTIFICATION.— ‘‘(1) IN GENERAL.— ‘‘(A) INITIAL CERTIFICATION.—Upon the submission by an entity of an initial certification under subsection (a)(1), the Secretary shall determine if the certification meets the requirements of subparagraphs (A) and (B) of such subsection. ‘‘(B) SUBSEQUENT CERTIFICATION.—Upon the submission by an entity of a subsequent certification under subsection (a)(2), the Secretary shall review the certification with respect to requirements of subparagraphs (A) and (B) of such subsection. ‘‘(2) NOTICE OF ACCEPTANCE OR NON-ACCEPTANCE.—If the Secretary determines that— ‘‘(A) an entity’s initial certification meets requirements referred to in paragraph (1)(A), the Secretary shall notify the entity of the acceptance of such certification; or

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