These rules and regulations pertaining to the Rhode Island Traumatic Brain Injury/Spinal Cord Injury Registry are promulgated pursuant to the authority conferred in R.I. Gen. Laws § 23-1-49 for the purpose of establishing a unified procedure for the reporting of traumatic brain injuries and spinal cord injuries to the Rhode Island Traumatic Brain Injury Spinal Cord Injury Registry maintained by the Rhode Island Department of Health.

These regulations hereby adopt and incorporate the U.S. Department of Health and Human Services “International Classification of Disease, 9th Revision Clinical Modification” (1989), by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations.

A. Wherever used in these rules and regulations the following terms shall be construed as follows:

1. "Act" means R.I. Gen. Laws § 23-1-49.

2. “Traumatic brain injury” means all injuries codes: 310.2, 800, 801, 803, 804, 850, 851, 852, 853, 854, 959.01, 905.0, and 907.0 as defined by the International Classification of Disease, 9th Revision Clinical Modification, incorporated above at § 4.2 of this Part.

3. “Spinal cord injury” means all injuries codes: 806, 952, and 907.2 as defined by the International Classification of Disease, 9th Revision Clinical Modification, incorporated above at § 4.2 of this Part.

4. “Department” means the Rhode Island Department of Health.

5. “Director” means the Director of the Department of Health.

6. "Hospital" means a facility licensed in Rhode Island with a governing body, an organized medical staff and a nursing service providing equipment and services primarily for inpatient care to persons who require definitive diagnosis and treatment for injury, illness or other disabilities or pregnancy. A hospital shall provide psychiatric and/or medical and/or surgical care and at least the following services: dietetic, infection control, medical records, laboratory, pharmaceutical and radiology, except that a psychiatric facility need not provide radiology services.

7. "Registrar of the Traumatic Brain Injury/Spinal Cord Injury Registry" hereinafter referred to as Registrar, means the person within the Department designated by the Director to be responsible for the operation of the Rhode Island Traumatic Brain Injury/Spinal Cord Injury Registry.

8. "Rhode Island Traumatic Brain Injury/Spinal Cord Injury Registry" means the central registry established within the Department by the Director pursuant to the Act as the statewide registry for the collection and recording of information on all cases of traumatic brain injuries and spinal cord injuries for the purpose of describing the occurrence of traumatic brain injury and spinal cord injury among Rhode Islanders; detecting trends of morbidity and mortality, stimulating epidemiological research, diminishing the impact of these injuries; and identifying survivors of these injuries in order to intervene on a timely basis for treatment.

A. All newly diagnosed traumatic brain and/or spinal cord injuries and the submission of any specified additional information on reported injuries that the Director deems necessary and appropriate for the recognition, prevention, or control of those injuries shall be reported to the Department in the manner described herein.

1. All cases of traumatic brain injury and spinal cord injury as listed in § 4.5 of this Part diagnosed on and after July 1, 2007 shall be reportable by hospitals in accordance with the statutory and regulatory provisions herein. Reporting is required for all such injuries occurring in Rhode Island.

2. The administrative officer, or his/her designee, of each hospital shall be responsible for establishing the reporting procedures at that facility. These procedures shall ensure that every case that is diagnosed either in the facility-operated inpatient or emergency department shall be reported to the Registry. Cases wherein death occurs prior to discharge from the facility shall also be reported to the Registry.

3. Within fourteen (14) days from the date of diagnosis or confirmation of a new case of a reportable traumatic brain injury or spinal cord injury as listed in § 4.5 of this Part, a hospital shall report in the manner specified by the Department all the information and data requested. The originating hospital shall retain a duplicate copy of submitted information for a two (2) year period from the date of submission.

4. Nothing under the provisions of the Act and the rules and regulations herein shall be construed to compel any individual to submit to medical or Departmental examination or supervision.

A. Hospitals shall report those injuries identified by the following selected codes listed in the publication entitled, “International Classifications of Diseases, 9th Revision, Clinical Modification” as incorporated above at § 4.2 of this Part:

1. Traumatic Brain Injury

a. 310.2 Post-concussion syndrome/post traumatic encephalopathy

b. 800 Skull fracture (vault)

c. 801 Skull fractures (base)

d. 803 other and unqualified skull fractures

e. 804 Multiple fracture of skull and face with other bones

f. 850 Concussion

g. 851 cerebral laceration/ confusions

h. 852 SAH, SDH & EDH with SD injury

i. 853 other and unspecified IC hemorrhage

j. 854 IC injury other and unspecified

k. 995.55 Shaken Infant Syndrome

l. 959.01 Head injury unspecified

2. Spinal cord injury

a. 806 fracture, vertebral column with spinal cord injury

b. 952 Spinal cord injury

3. Late Effects TBI/SCI

a. 905.0 Skull fracture

b. 907.0 intracerebral injury

c. 907.2 Spinal cord injury

B. Each hospital shall submit data in such a manner as to make uniform a system of periodic reporting and shall include no less than the following detailed statistical data and information:

1. Patient’s full name;

2. Social Security number;

3. Street address, city or town, state and zip code at the time of diagnosis;

4. Date of birth;

5. Sex;

6. Ethnicity: Hispanic or Latino; Non-Hispanic or Latino;

7. Race: White; Black or African American; Asian; American Indian or Alaska Native; Native Hawaiian or Pacific Islander; Other;

8. Date of injury;

9. Date of admission;

10. Date of discharge;

11. Place of incident (ICD-9 Place of Occurrence codes E849);

12. Traumatic Brain/Spinal Cord Injury related diagnosis (ICD-9 CM codes and description as stated above);

13. Other diagnosis codes (ICD-9 CM codes and descriptions);

14. Cause of injury (ICD-9 CM external cause codes E800.0-E999.9);

15. Initials of person completing the form;

16. Type of discharge (code specified on form);

17. Hospital code;

18. Patient medical record number;

19. Date form completed.

C. Data and information on cases of traumatic brain injury/spinal cord injury shall be reported electronically or by US postal mail unless reporting by another means has been approved in writing by the Director.

D. Such data and information shall be abstracted from medical charts and other sources of patient information by personnel possessing, at a minimum, a basic working knowledge of medical terminology, human anatomy, and physiology.

E. Such data and information shall be coded in a manner specified by the Director.

F. Such data and information shall be submitted with sufficient narrative substantiation to allow a visual assessment of the accuracy of coded data and information.

4.5.1 Rights of Survivors/Parents/Legal Guardians

A. The Department shall remove personal identifying information from the Registry upon request of the traumatic brain injury/spinal cord injury survivor or legal guardians. The survivor or legal guardian shall also have the right to prohibit being contacted by the Department.

B. The Department shall provide timely notification to survivors or legal guardians of their rights as stated above.

The Traumatic Brain Injury/Spinal Cord Injury Registry shall maintain comprehensive records of all reports submitted pursuant to the Act and the rules and regulations herein. These reports shall be confidential in accordance with R.I. Gen. Laws Chapter 5-37.3 and subject to the restrictions on release incorporated in that Chapter.

All individual records and aggregate data including abstract report forms relating to the Rhode Island Traumatic Brain Injury/Spinal Cord Injury Registry are the property of the Department. The use of records and aggregate data by any person shall be subject to the approval of the Director. Furthermore, requests for access to data compiled pursuant to the provisions of these regulations may be granted only by the Director in accordance with applicable federal and state law, rules and regulations regarding confidentiality and public access to data.

Failure of any health care facility to comply with the provisions of the Acts and the rules and regulations herein shall be subject to sanctions and referred to the appropriate licensing and/or disciplinary body.

Modification of any individual rule and regulation herein may be granted by the Director upon motion of the Rhode Island Traumatic Brain Injury/Spinal Cord Injury Registry are or upon request of a contracting agency and/or organization in a specific case, if the Director finds that the modification to the rule is not contrary to the purpose of the Rhode Island Traumatic Brain Injury/Spinal Cord Injury Registry nor contrary to the public interest. Provided, however, modifications shall not be made to the confidentiality protections contained in §§ 4.5.1, 4.6 and 4.7 of this Part.

If any provision of the rules and regulations herein or the application thereof to any facility or provider or circumstances shall be held invalid, such invalidity shall not affect the provisions or application of the regulations which can be given effect, and to this end the provisions of the rules and regulations are declared to be severable.