22 | | - | a. 1. Prominently display, on a website maintained by the department, a link to the federal |
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23 | | - | vaccine adverse event reporting system, along with instructions on how to report an |
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24 | | - | adverse event and how to access state-specific data. The department may compile its |
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25 | | - | own data for use on this website.; and |
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26 | | - | b. 2. Provide information about the vaccine adverse event data system maintained by the |
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27 | | - | department under section 2 of this Act, including recording and reporting requirements |
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28 | | - | for health care providers By July first of each even - numbered year, provide a report to |
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29 | | - | the legislative management of all state-specific data and a summary of all reported |
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30 | | - | data nationally . |
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31 | | - | Page No. 1 25.0296.03002 |
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| 18 | + | a.Prominently display, on a website maintained by the department, a link to the |
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| 19 | + | federal vaccine adverse event reporting system, along with instructions on how to |
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| 20 | + | report an adverse event and how to access state-specific data. The department |
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| 21 | + | may compile its own data for use on this website.; and |
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| 22 | + | b.Provide information about the vaccine adverse event data system maintained by |
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| 23 | + | the department under section 2 of this Act, including recording and reporting |
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| 24 | + | requirements for health care providers. |
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| 25 | + | 2.The department of health and human services may compile its own data for use on its |
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| 26 | + | website. |
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| 27 | + | SECTION 2. A new section to chapter 23-12 of the North Dakota Century Code is created |
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| 28 | + | and enacted as follows: |
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| 29 | + | Page No. 1 25.0296.03000 |
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59 | 55 | | Vaccine adverse event data - Recording - Report to department and legislative |
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60 | 56 | | management - Vaccine adverse event data system fund - Continuing appropriation. |
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61 | 57 | | 1.As used in this section: |
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62 | 58 | | a."Department" means the department of health and human services. |
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63 | 59 | | b."Health care provider" means a licensed individual or facility providing health care |
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64 | 60 | | services. |
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65 | 61 | | c."Vaccine" means a vaccine recommended by the federal advisory committee on |
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66 | 62 | | immunization practices of the centers for disease control and prevention. |
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67 | 63 | | d."Vaccine administration error" means a preventable event that may cause or lead |
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68 | 64 | | to inappropriate vaccine use or patient harm. The term includes administering a |
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69 | 65 | | wrong or expired vaccine; using the incorrect route, site, or dosage; scheduling |
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70 | 66 | | errors; improper preparation or storage; and administering a vaccine to the wrong |
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71 | 67 | | individual. |
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72 | 68 | | 2.The department shall: |
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73 | 69 | | a.Establish and administer a system to record and compile reported vaccine |
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74 | 70 | | adverse event data; |
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75 | 71 | | b.Designate the adverse events a health care provider shall report to the |
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76 | 72 | | department, including: |
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77 | 73 | | (1)An adverse event required to be reported under the National Childhood |
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78 | 74 | | Vaccine Injury Act of 1986 [Pub. L. 99-660; 100 Stat. 3774; 42 U.S.C. |
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79 | 75 | | 300aa-25 et seq.]; and |
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80 | 76 | | (2)A vaccine administration error; |
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81 | 77 | | c.Establish time frames and methods for reporting; |
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82 | 78 | | d.Develop forms for reporting ; |
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83 | 79 | | e.Adopt rules necessary to implement this section; and |
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121 | | - | 4. A member of the public may report an adverse event to the department in a manner |
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122 | | - | prescribed by the department. |
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123 | | - | 5. A report required by this section and held by the department is confidential |
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124 | | - | information. Unless otherwise provided by law, information that may identify an |
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125 | | - | individual may not be disclosed to any person except: |
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126 | | - | a. The individual who received the vaccine, or that individual's parent, legal |
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127 | | - | guardian, or legal representative; and |
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128 | | - | b. For statistical purposes, in a manner such that personally identifiable information |
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129 | | - | can not be identified. |
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130 | | - | 6. An officer or employee of the department may not be examined in any judicial, |
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131 | | - | executive, legislative, or other proceeding regarding the existence or content of any |
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132 | | - | individual's report retained by the department under this section. |
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133 | | - | 7. There is created in the state treasury a vaccine adverse event data system fund. The |
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134 | | - | fund consists of all moneys transferred to the fund and all interest and earnings upon |
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135 | | - | moneys in the fund. Moneys in the fund are appropriated to the department on a |
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136 | | - | continuing basis for the purpose of administering the provisions of this chapter. |
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137 | | - | SECTION 3. APPROPRIATION - DEPARTMENT OF HEALTH AND HUMAN SERVICES - |
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138 | | - | VACCINE ADVERSE EVENT DATA SYSTEM. There is appropriated out of any moneys in the |
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139 | | - | general fund in the state treasury, not otherwise appropriated, the sum of $100,000, or so much |
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140 | | - | of the sum as may be necessary, to the department of health and human services for the |
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141 | | - | purpose of establishing and administering a system to record and compile reported vaccine |
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142 | | - | adverse event data, for the biennium beginning July 1, 2025, and ending June 30, 2027. |
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143 | | - | SECTION 4. EXPIRATION DATE. This Act is effective through June 30, 2029, and after that |
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144 | | - | date is ineffective. |
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145 | | - | Page No. 3 25.0296.03002 |
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| 86 | + | Page No. 2 25.0296.03000 |
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| 117 | + | 31 Sixty-ninth |
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| 118 | + | Legislative Assembly |
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| 119 | + | 4.A member of the public may report an adverse event to the department in a manner |
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| 120 | + | prescribed by the department. |
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| 121 | + | 5.A report required by this section and held by the department is confidential |
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| 122 | + | information. Unless otherwise provided by law, information that may identify an |
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| 123 | + | individual may not be disclosed to any person except: |
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| 124 | + | a.The individual who received the vaccine, or that individual's parent, legal |
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| 125 | + | guardian, or legal representative; and |
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| 126 | + | b.For statistical purposes, in a manner such that personally identifiable information |
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| 127 | + | can not be identified. |
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| 128 | + | 6.An officer or employee of the department may not be examined in any judicial, |
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| 129 | + | executive, legislative, or other proceeding regarding the existence or content of any |
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| 130 | + | individual's report retained by the department under this section. |
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| 131 | + | 7.There is created in the state treasury a vaccine adverse event data system fund. The |
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| 132 | + | fund consists of all moneys transferred to the fund and all interest and earnings upon |
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| 133 | + | moneys in the fund. Moneys in the fund are appropriated to the department on a |
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| 134 | + | continuing basis for the purpose of administering the provisions of this chapter. |
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| 135 | + | SECTION 3. APPROPRIATION - DEPARTMENT OF HEALTH AND HUMAN SERVICES - |
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| 136 | + | VACCINE ADVERSE EVENT DATA SYSTEM. There is appropriated out of any moneys in the |
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| 137 | + | general fund in the state treasury, not otherwise appropriated, the sum of $100,000, or so much |
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| 138 | + | of the sum as may be necessary, to the department of health and human services for the |
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| 139 | + | purpose of establishing and administering a system to record and compile reported vaccine |
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| 140 | + | adverse event data, for the biennium beginning July 1, 2025, and ending June 30, 2027. |
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| 141 | + | SECTION 4. EXPIRATION DATE. This Act is effective through June 30, 2029, and after that |
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| 142 | + | date is ineffective. |
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| 143 | + | Page No. 3 25.0296.03000 |
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