Section 550.100  Definitions

 

The definitions listed in this Section apply to this Part.

 

"Act" means the Head and Spinal Cord Injury Act [410 ILCS 515].

 

"Bona Fide Researcher" means an individual with prior experience in conducting published medical or epidemiological studies. This includes but is not limited to prior experience with the publications of medical and/or epidemiological research, or scientific affiliation with a hospital or accredited U.S. university. The researcher must, at minimum, possess a master’s degree from an accredited U.S. university in a medical or scientific discipline.

 

"Council" means the Advisory Council on Spinal Cord and Head Injuries, created within the Department of Rehabilitation Services pursuant to Section 6 of the Act. (Section 1 of the Act)

 

"Department" means the Department of Public Health. (Section 1 of the Act)

 

"Head Injury" means a sudden insult or damage to the brain or its coverings, not of a degenerative nature, which produces an altered state of consciousness or temporarily or permanently impairs mental, cognitive, behavioral or physical functioning. Cerebral vascular accidents, aneurysms and congenital deficits are excluded from this definition. (Section 1 of the Act)

 

"Hospital" has the meaning ascribed to that term in the Hospital Licensing Act [210 ILCS 85].

 

"Spinal Cord Injury" means an injury that occurs as a result of trauma, which involves spinal vertebral fracture, or where the injured person suffers any of the following effects: effects on the sensory system including numbness, tingling or loss of sensation in the body or in one or more extremities; effects on the motor system including weakness or paralysis in one or more extremities; effects on the visceral system including bowel or bladder dysfunction or hypotension. (Section 1 of the Act)

 

(Source:  Amended at 46 Ill. Reg. 15700, effective August 30, 2022)

 

Section 550.110  Incorporated and Referenced Materials

 

a)         The following standards are incorporated in this Part:

 

World Health Organization International Classification of Diseases, which may be accessed at https://www.who.int/standards/classifications/classification-of-diseases

 

b)         The following statutes are referenced in this Part:

 

1)         Hospital Licensing Act [210 ILCS 85];

 

2)         Head and Spinal Cord Injury Act [410 ILCS 515].

 

(Source:  Amended at 46 Ill. Reg. 15700, effective August 30, 2022)

 

Section 550.120  Reporting Requirements

 

a)         The Department shall establish and maintain an information registry and reporting system for the purpose of data collection and needs assessment of head and spinal cord injured persons in this State. (Section 2 of the Act)

 

b)         Each hospital with an emergency department must report electronically the required information as specified by the Division of Emergency Medical Service. The Department shall provide access to internet-based data collection software for submission of required information.

 

c)         All hospitals with emergency departments shall report information quarterly on each patient diagnosed as a head or spinal cord injured patient who is:

 

1)         Admitted to the hospital as an in-patient admission, including observation admissions; patients that are admitted to the emergency department and die before in-patient admission; or

 

2)         Transferred to another acute care hospital for definitive treatment of the head or spinal cord injury.

 

d)         The required information to be reported, such as name, age, residence of the patient, and the corresponding ICD codes, can be found on the Department’s website at: https://dph.illinois.gov/topics-services/emergency-preparedness-response/ems/trauma-program/headspinal-cord-and-violent-injury-registry-hsvi.html

 

e)         The reporting schedule is as follows:

 

Patient Admission	Report Due Date
January – March	June 30
April – June	September 30
July – September	December 31
October – December	March 31

 

(Source:  Amended at 46 Ill. Reg. 15700, effective August 30, 2022)

 

Section 550.130  Confidentiality and Availability of Data

 

a)         All reports and records made pursuant to the Act and maintained by the Department and other appropriate persons, officials and institutions pursuant to the Act shall be confidential. Information shall not be made available to any individual or institution except to:

 

1)         Appropriate staff of the Department;

 

2)         Any person engaged in a bona fide research project, with the permission of the Director of Public Health, except that no information identifying the subjects of the reports or the reporters shall be made available to researchers unless the Department requests and receives consent for such release pursuant to the provisions of this Section;

 

3)         The Council, except that no information identifying the subjects of the reports or the reporters shall be made available to the Council unless consent for release is requested and received pursuant to the provisions of this Section. Only information pertaining to head and spinal cord injuries as defined in Section 1 of the Act shall be released to the Council. (Section 3 of the Act); and

 

4)         The Department for the purpose of injury prevention or determining the impact of head and spinal cord injuries.

 

A)        All information and data shared with the Department shall be kept confidential and limited to the scope of the project. No data may be shared with the Department that could lead to the identity of any facility, or the identity of any person whose condition or treatment is submitted to the Department.

 

B)        The Department requesting data shall enter into a written agreement with the Division of EMS which shall include, at minimum:

 

i)          Data being requested;

 

ii)         Proposed usage of data;

 

iii)        Responsible Individual charged with ensuring the confidentiality of the data.

 

C)        The written agreement must be approved by the providing and receiving Department Deputy Director and the Director of the Department.

 

b)         The Department shall not reveal the identity of a patient, physician or hospital, except that the identity of the patient may be released upon written consent of the patient, parent (in the case of a minor patient) or guardian, the identity of the physician may be released upon written consent of the physician; and the identity of the hospital may be released upon written consent of the hospital. (Section 3 of the Act)

 

c)         The Department shall request consent for release from a patient, a physician or hospital only upon a showing by the applicant for such release that obtaining the identities of certain patients, physicians or hospitals is necessary for his bona fide research directly related to the objectives of the Act. (Section 3 of the Act)

 

d)         The Department shall at least annually compile a report of the data accumulated through the reporting system established under Section 2 of the Act and shall submit such data relating to spinal cord and head injuries in accordance with confidentiality restrictions established pursuant to the Act to the Council. (Section 3 of the Act)

 

e)         Head and Spinal Cord Injury Registry data may be provided for medical or epidemiological research by bona fide scientific researchers in accordance with subsection (f). All requests by bona fide scientific researchers for such data must be submitted in writing to the Department at https://dph.illinois.gov/data-statistics/institutional-review-board.html. The request must include a study protocol that contains:  objectives of the research; rationale for the research including scientific literature justifying the current proposal; overall study methods, including copies of forms, questionnaires, and consent forms used to contact facilities, physicians or study subjects; methods for the processing of data; storage and security measures taken to ensure confidentiality of patient and facility identifying information; time frame of the study; a description of the funding source of the study (e.g., federal contract); the curriculum vitae of the principal researcher and a list of collaborators. In addition, the research request must specify what patient or facility identifying information is needed and how the information will be used.

 

f)         All requests to conduct research and modifications to approved research proposals involving the use of data that includes patient or facility identifying information shall be subject to a review to determine compliance with all the following conditions:

 

1)         The request for patient or facility identifying information contains stated goals or objectives.

 

2)         The request documents the feasibility of the study design in achieving the stated goals and objectives.

 

3)         The request documents the need for the requested data to achieve the stated goals and objectives.

 

4)         The requested data can be provided within the time frame set forth in the request.

 

5)         The request clearly documents that the principal researcher has qualifications relevant to the type of research being conducted and qualifies as a bona fide researcher.

 

6)         The research will not duplicate other research already underway using the same registry data when both require the contact of a patient, reporting facility or physician about an individual patient involved in the previously approved concurrent research.

 

7)         Other such conditions relevant to the need for the patient or facility identifying information and the patient's confidentiality rights. The Department will only release the patient, physician in accordance with the provisions of this Section, or facility identifying information that is necessary for the research.

 

g)         The Department will enter into a written Research Agreement for all approved research requests. The Agreement shall specify the information that is being released and how it can be used, in accordance with subsection (e) above. The Department will only provide available data relevant to the goals and objectives of the specific research approved by the Department.

 

h)         The identity of any facility or individual, or any group of facts that tends to lead to the identity of any person whose condition or treatment is submitted to the Department, shall not be open to public inspection or dissemination.

 

i)          Every hospital shall provide representatives of the Department with access to information from all medical, pathological, and other pertinent records and logs related to reportable registry information. The Department shall not require hospitals to provide information on cases that are dated more than two years before the Department's request for further information.

 

j)          Every hospital shall provide access to information regarding specified patients or other patients specified for research studies, related to reportable registry information, conducted by the Department.

 

(Source:  Amended at 46 Ill. Reg. 15700, effective August 30, 2022)

Section 550.APPENDIX A   Head and Spinal Cord Injury Reporting/Violent Injury Reporting (Repealed)

 

(Source:  Repealed at 46 Ill. Reg. 15700, effective August 30, 2022)