patient safety work product
(7) Patient safety work product (A) In general Except as provided in subparagraph (B), the term “patient safety work product” means any data, reports, records, memoranda, analyses (such as root cause analyses), or written or oral statements— (i) which— (I) are assembled or developed by a provider for reporting to a patient safety organization and are reported to a patient safety organization; or (II) are developed by a patient safety organization for the conduct of patient safety activities; and which could result in improved patient safety, health care quality, or health care outcomes; or (ii) which identify or constitute the deliberations or analysis of, or identify the fact of reporting pursuant to, a patient safety evaluation system. (B) Clarification (i) Information described in subparagraph (A) does not include a patient’s medical record, billing and discharge information, or any other original patient or provider record. (ii) Information described in subparagraph (A) does not include information that is collected, maintained, or developed separately, or exists separately, from a patient safety evaluation system. Such separate information or a copy thereof reported to a patient safety organization shall not by reason of its reporting be considered patient safety work product. (iii) Nothing in this part shall be construed to limit— (I) the discovery of or admissibility of information described in this subparagraph in a criminal, civil, or administrative proceeding; (II) the reporting of information described in this subparagraph to a Federal, State, or local governmental agency for public health surveillance, investigation, or other public health purposes or health oversight purposes; or (III) a provider’s recordkeeping obligation with respect to information described in this subparagraph under Federal, State, or local law.