25.0296.03002 Title.04000 Adopted by the Human Services Committee Sixty-ninth February 19, 2025 Legislative Assembly of North Dakota Introduced by Representative D. Anderson A BILL for an Act to create and enact a new section to chapter 23-12 of the North Dakota Century Code, relating to recording and reporting vaccine adverse event data; to amend and reenact section 23-12-22 of the North Dakota Century Code, relating to the publication of vaccine adverse event data and information; and to provide for a legislative management report; to provide an appropriation; to provide a continuing appropriation; and to provide an expiration date. BE IT ENACTED BY THE LEGISLATIVE ASSEMBLY OF NORTH DAKOTA: SECTION 1. AMENDMENT. Section 23-12-22 of the North Dakota Century Code is amended and reenacted as follows: 23-12-22. Vaccine adverse event data - Website. 1.The department of health and human services shall prominently: a. 1. Prominently display, on a website maintained by the department, a link to the federal vaccine adverse event reporting system, along with instructions on how to report an adverse event and how to access state-specific data. The department may compile its own data for use on this website.; and b. 2. Provide information about the vaccine adverse event data system maintained by the department under section 2 of this Act, including recording and reporting requirements for health care providers By July first of each even - numbered year, provide a report to the legislative management of all state-specific data and a summary of all reported data nationally . Page No. 1 25.0296.03002 HOUSE BILL NO. 1467 PROPOSED AMENDMENTS TO 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Sixty-ninth Legislative Assembly 2. The department of health and human services may compile its own data for use on its website. SECTION 2. A new section to chapter 23-12 of the North Dakota Century Code is created and enacted as follows: Vaccine adverse event data - Recording - Report to department and legislative management - Vaccine adverse event data system fund - Continuing appropriation. 1. As used in this section: a. "Department" means the department of health and human services. b. "Health care provider" means a licensed individual or facility providing health care services. c. "Vaccine" means a vaccine recommended by the federal advisory committee on immunization practices of the centers for disease control and prevention. d. "Vaccine administration error" means a preventable event that may cause or lead to inappropriate vaccine use or patient harm. The term includes administering a wrong or expired vaccine; using the incorrect route, site, or dosage; scheduling errors; improper preparation or storage; and administering a vaccine to the wrong individual. 2. The department shall: a. Establish and administer a system to record and compile reported vaccine adverse event data; b. Designate the adverse events a health care provider shall report to the department, including: (1) An adverse event required to be reported under the National Childhood Vaccine Injury Act of 1986 [Pub. L. 99-660; 100 Stat. 3774; 42 U.S.C. 300aa-25 et seq.]; and (2) A vaccine administration error; c. Establish time frames and methods for reporting; d. Develop forms for reporting; e. Adopt rules necessary to implement this section; and Page No. 2 25.0296.03002 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 Sixty-ninth Legislative Assembly f. By July first of each even - numbered year, provide a comprehensive report to the legislative management, which includes a summary of all reported data and the overall effectiveness of the system. 3. A health care provider that administers a vaccine to an individual shall report every occurrence of an adverse event to the department, on a form prescribed by the department. 4. A member of the public may report an adverse event to the department in a manner prescribed by the department. 5. A report required by this section and held by the department is confidential information. Unless otherwise provided by law, information that may identify an individual may not be disclosed to any person except: a. The individual who received the vaccine, or that individual's parent, legal guardian, or legal representative; and b. For statistical purposes, in a manner such that personally identifiable information can not be identified. 6. An officer or employee of the department may not be examined in any judicial, executive, legislative, or other proceeding regarding the existence or content of any individual's report retained by the department under this section. 7. There is created in the state treasury a vaccine adverse event data system fund. The fund consists of all moneys transferred to the fund and all interest and earnings upon moneys in the fund. Moneys in the fund are appropriated to the department on a continuing basis for the purpose of administering the provisions of this chapter. SECTION 3. APPROPRIATION - DEPARTMENT OF HEALTH AND HUMAN SERVICES - VACCINE ADVERSE EVENT DATA SYSTEM. There is appropriated out of any moneys in the general fund in the state treasury, not otherwise appropriated, the sum of $100,000, or so much of the sum as may be necessary, to the department of health and human services for the purpose of establishing and administering a system to record and compile reported vaccine adverse event data, for the biennium beginning July 1, 2025, and ending June 30, 2027. SECTION 4. EXPIRATION DATE. This Act is effective through June 30, 2029, and after that date is ineffective. 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