Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 10 - Facility regulation › Part 6 - Patient Safety Organizations (216-RICR-40-10-6) › Section 216-RICR-40-10-6.3 - Definitions

Current through June 14, 2024
A. 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; or
b. 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; or
c. 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; and
f. 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; or
c. 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.