Section 216-RICR-40-10-6.3 - DefinitionsA. Whenever used in these rules and regulations, the following terms shall be construed as follows: 1. "Act" means R.I. Gen. Laws Chapter 23-17.21, entitled "The Rhode Island Patient Safety Act of 2008."2. "Bona fide contract" means a written contract between a reporting entity and a PSO that is executed in good faith by officials authorized to execute such contract.3. "Component organization" means an entity that is either: a. A unit or division of a corporate organization or of a multi-organizational enterprise; orb. A separate organization, whether incorporated or not, that is owned, managed or controlled by one or more other organization(s), i.e., its parent organization(s).4. "Component PSO" means a patient safety organization certified by the Director that is a component organization.5. "Department" means the Rhode Island Department of Health.6. "Director" means the Director of the Rhode Island Department of Health.7. "Document log" means an inventory or record, required pursuant to R.I. Gen. Laws § 23-17.21-6(b), which itemizes the types of documents submitted to the PSO without indicating the content of such documents.8. "Entity" means any organization or organizational unit, regardless of whether the organization is public, private, for-profit or not-for-profit.9. "Health care facility" means any corporation, limited liability company, facility, or institution licensed by this state to provide health care or professional services, or an officer, employee or agent thereof acting in the course and scope of his or her employment.10. "Identifiable patient safety work product" means patient safety work product that: a. Is presented in a form and manner that allows the identification of any provider or reporting entity that is a subject of the work product, or any providers or reporting entities that participate in activities that are a subject of the work product;b. Constitutes individually identifiable health information as that term is defined in the Health Insurance Portability and Accountability Act, 42 U.S.C. § 1320d-6 and its implementing regulations; orc. Is presented in a form and manner that allows the identification of an individual.11. "Near misses" means circumstances in which a patient safety event is narrowly averted.12. "Nonidentifiable patient safety work product" means patient safety work product that is not identifiable patient safety work product as defined in these regulations.13. "Patient safety activities" means: a. Efforts to improve patient safety and the quality of health care delivery;b. The collection and analysis of patient safety work product;c. The development and dissemination of information with respect to improving patient safety, such as recommendations, protocols, or information regarding best practices;d. The utilization of patient safety work product for the purposes of encouraging a culture of safety and of providing feedback and assistance to effectively minimize patient risk;e. The maintenance of procedures to preserve confidentiality with respect to patient safety work product; andf. The provision of appropriate security measures with respect to patient safety work product.14. "Patient safety event" means those events as defined by the national quality forum, institute of medicine, Center for Medicare and Medicaid Services (CMS), and as further defined by the Quality of Care Advisory Committee, as established in this Part pursuant to RI Gen Laws § 23-17.21-5(b), and shall include near misses.15. "Patient safety organization (PSO)" means any entity certified by the Director whose activity is to improve patient safety and the quality of health care delivery for patients receiving care through the collection, aggregation, analysis, investigation, and/or processing of medical or health care related information submitted to it by reporting entities. A PSO shall not mean any agency or public body as defined in R.I. Gen. Laws § 38-2-2(1).16. "Patient safety work product" means all reports, records, memoranda, analyses, statements, root cause analyses, and written or oral statements, that: a. A health care facility or provider prepares for the purpose of disclosing a patient safety event, and is disclosed, to a patient safety organization;b. Is received from a reporting entity, and is created and analyzed by a patient safety organization; orc. Directly or indirectly contains deliberations, analytical process, recommendations, conclusions, or other communications of a patient safety organization and between a patient safety organization and health care providers or facilities.17. "Quality of Care Advisory Committee" means the committee established by the Director, pursuant to R.I. Gen. Laws § 23-17.21-5(b), to advise the Department on PSO-related issues.18. "Reporting entity" means any hospital, nursing facility or freestanding ambulatory surgical center licensed pursuant to R.I. Gen. Laws §23-17.216 R.I. Code R. § 216-RICR-40-10-6.3