42 CFR § 480.101 - Scope and definitions.
(a)Scope. This subpart sets forth the policies and procedures governing -
(1) Disclosure of information collected, acquired or generated by a Utilization and Quality Control Quality Improvement Organization (QIO) (or the review component of a QIO subcontractor) in performance of its responsibilities under the Act and these regulations; and
(b)Definitions. As used in this part:
Aggregate statistical data means any utilization, admission, discharge or diagnostic related group (DRG) data arrayed on a geographic, institutional or other basis in which the volume and frequency of services are shown without identifying any individual.
Confidential information means any of the following:
(2)Sanction reports and recommendations.
(3) Quality review studies which identify patients, practitioners or institutions.
Non-facility organization means a corporate entity that: (1) Is not a health care facility; (2) is not a 5 percent or more owner of a facility; and (3) is not owned by one or more health care facilities in the QIO area.
Patient representative means - (1) an individual designated by the patient, in writing, as authorized to request and receive QIO information that would otherwise be disclosable to that patient; or (2) an individual identified by the QIO in accordance with § 480.132(c)(3) when the beneficiary is mentally, physically or legally unable to designate a representative.
Practitioner means an individual credentialed within a recognized health care discipline and involved in providing the services of that discipline to patients.
Public information means information which has been disclosed to the public.
QIO deliberations means discussions or communications (within a QIO or between a QIO and a QIO subcontractor) including, but not limited to, review notes, minutes of meetings and any other records of discussions and judgments involving review matters regarding QIO review responsibilities and appeals from QIO determinations, in which the opinions of, or judgment about, a particular individual or institution can be discerned.
QIO interpretations and generalizations on the quality of health care means an assessment of the quality of care furnished by an individual provider or group of providers based on the QIO's knowledge of the area gained from its medical review experience (e.g., quality review studies) and any other information obtained through the QIO's review activities.
QIO review system means the QIO and those organizations and individuals who either assist the QIO or are directly responsible for providing medical care or for making determinations with respect to the medical necessity, appropriate level and quality of health care services that may be reimbursed under the Act. The system includes -
(1) The QIO and its officers, members and employees;
(5) Data support organizations; and
Quality review study means an assessment, conducted by or for a QIO, of a patient care problem for the purpose of improving patient care through peer analysis, intervention, resolution of the problem and follow-up.
Quality review study information means all documentation related to the quality review study process.
Sanction report means a report filed pursuant to section 1156 of the Act and part 474 of this chapter documenting the QIO's determination that a practitioner or institution has failed to meet obligations imposed by section 1156 of the Act.
Shared health data system means an agency or other entity authorized by Federal or State law that is used by the QIO review system to provide information or to conduct or arrange for the collection, processing, and dissemination of information on health care services.