SECTION 100.1. Definitions

The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise.

(1) Child--An individual younger than 18 years of age to whom a vaccine has been administered.

(2) Consent--A statement signed by an individual or the individual's legally authorized representative agreeing that the individual's immunization history can be included in the immunization registry and that the individual's immunization record may be released from the immunization registry.

(3) Data elements--The information:

(A) consistent with 42 U.S.C., §300aa-25, as amended, defined as the information a provider who administers a vaccine is required to record in a medical record, including:

(i) the date the vaccine is administered;

(ii) the type of vaccine administered, vaccine manufacturer and lot number;

(iii) the name, address, and if appropriate, the title of the provider administering the vaccine; and

(iv) any adverse or unexpected events for a vaccine; and

(B) relating to an immunization, antiviral, and/or other medication administered to prepare for a potential disaster, public health emergency, terrorist attack, hostile military or paramilitary action, or extraordinary law enforcement emergency or in response to a declared disaster, public health emergency, terrorist attack, hostile military or paramilitary action, or extraordinary law enforcement emergency.

(4) Department--The Department of State Health Services.

(5) Extraordinary Law Enforcement Emergency--Within the context of a public health emergency, a situation which requires extra staffing, overtime and/or extra-jurisdictional law enforcement forces.

(6) First Responder--As defined by Texas Health and Safety Code, §161.0001.

(7) Health information exchange--A health information exchange organization as defined by Texas Health and Safety Code, §182.151.

(8) Hostile Military or Paramilitary Act--An attack or other use of force by an armed force of a nation or an organized unofficial group, against forces, property and/or infrastructure of the United States, state or local government.

(9) Immediate family member--The parent, spouse, child, or sibling of an individual who resides in the same household as the individual.

(10) Immunization history--An accounting of all vaccines that an individual has received, or evidence of immunity, and other identifying information.

(11) Immunization record--A record containing the name and date of birth of the individual to whom a vaccine was administered; dates of vaccine administration; types of vaccine administered; and name and address of the provider that administered the vaccines; or other evidence of immunity to a vaccine-preventable disease.

(12) Immunization registry--The database or single repository that contains immunization histories, which include necessary personal data for identification. This database is confidential, and access to content is limited to authorized users.

(13) Individual--A child, or an adult 18 years of age or older, to whom a vaccine has been administered.

(14) Individual's legally authorized representative--As defined by Texas Health and Safety Code, §161.0001.

(15) Payor--An insurance company, a health maintenance organization, or another organization that pays a health care provider to provide health care benefits, including the administration of vaccines to an individual.

(16) Potential disaster--An incident or event capable of causing widespread or severe damage, injury, or loss of life or property resulting from any natural or man-made cause, including fire, flood, earthquake, wind, storm, wave action, oil spill or other water contamination, volcanic activity, epidemic, air contamination, blight, drought, infestation, explosion, riot, hostile military or paramilitary action, or other public calamity requiring emergency action, or energy emergency.

(17) Provider--Any physician, health care professional, or facility personnel duly licensed or authorized to administer vaccines.

(18) Public health emergency--An occurrence or imminent threat of an illness or health condition, caused by bioterrorism, epidemic or pandemic disease, or novel and highly fatal infectious agent or biological toxin, that poses a substantial risk of a significant number of human fatalities or incidents of permanent or long-term disability. Such illness or health condition includes, but is not limited to, an illness or health condition resulting from a natural disaster.

(19) Terrorist attack--An activity that is dangerous to human life and/or potentially destructive of critical infrastructure or key resources and is intended to intimidate or coerce the civilian population, or influence or affect the conduct of a government by mass destruction, assassination, and/or kidnapping.

(20) User--An entity or person authorized by the department to access immunization registry data.

(21) Vaccine--Includes toxoids and other immunologic agents which are administered to an individual to elicit an immune response (immunization) and thus protect against infectious diseases.

Source Note: The provisions of this §100.1 adopted to be effective May 6, 2004, 29 TexReg 4155; amended to be effective August 17, 2008, 33 TexReg 6384; amended to be effective April 2, 2017, 42 TexReg 1456; amended to be effective January 1, 2020, 44 TexReg 7984