216 R.I. Code R. § 216-RICR-40-10-6.3 - Definitions
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.
Notes
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