“Department” means the Maryland Department of Health. “Health care provider” means any licensed health care professional, organization, or institution, whether public or private, under whose authority pertussis vaccine is administered. “Major adverse reaction” means any: Serious illness, disability, or impairment of mental, emotional, behavioral, or physical functioning or development, the first manifestation of which appears within 7 days after the date of administration of pertussis vaccine and for which there is reasonable scientific or medical evidence pertussis vaccine causes, or significantly contributes to, the effect; and Other reaction which the Department, after consultation with the Medical and Chirurgical Faculty of Maryland, determines is a basis for not continuing with pertussis vaccine administration. “Patient” means the individual to whom pertussis vaccine is being administered. “Pertussis vaccine” means any vaccine that contains materials intended to prevent the occurrence of pertussis, whether the materials are administered separately or in conjunction with other materials intended to prevent the occurrence of other diseases. Before the administration of pertussis vaccine, the health care provider shall provide to the patient's parent or guardian written information addressing: The frequency, severity, and potential long-term effects of pertussis; Possible adverse reactions to pertussis vaccine, which, if they occur, should be brought to the immediate attention of the health care provider; A form that lists symptoms of possible pertussis vaccine adverse reactions to be monitored and which contains places where information can be recorded to assist in reporting to the health care provider, local health officer, and the Department; Measures parents should take to reduce the risk of, or to respond to, any major adverse reaction to pertussis vaccine; Early warning signs or symptoms to which parents should be alert as possible precursors to a major adverse reaction to pertussis vaccine; When and to whom parents should report any major adverse reactions to pertussis vaccine; A summary of the immunization requirements adopted under Education Article, §7-402(a), Annotated Code of Maryland, including those related to pertussis vaccine; The circumstances under which pertussis vaccine may not be administered; The circumstances under which administration of pertussis vaccine shall be delayed; and Categories of potential recipients who are significantly more vulnerable to major adverse reactions to pertussis vaccine than is the general population. Before the administration of pertussis vaccine, the health care provider shall, by appropriate inquiries, attempt to elicit the information necessary to determine, based on a physician's medical judgement whether: Pertussis vaccine should not be administered to the patient; Administration of pertussis vaccine should be delayed; or The risk to the potential recipient of the vaccine outweighs the benefits both to the potential recipient and to the public in administering the vaccine. The circumstances under which the administration of pertussis vaccine shall be delayed or may not occur are established by the Immunization Practices Advisory Committee (ACIP) to the Public Health Service. The Department will notify all health care providers of these circumstances. A physician who determines, pursuant to §B, of this regulation, that the administration of the pertussis vaccine to a patient shall be delayed or may not occur shall submit to the local health officer the name, address, date of birth, and the basis for the determination for each patient. Pertussis vaccine should not be given if in the physician's medical judgment, taking into account any categories of potential recipients who are significantly more vulnerable to major adverse reactions than is the general population, as well as all other relevant information, the risk to the potential recipient outweighs the benefits both to the potential recipient and the public in administering the vaccine. At the time of administration of pertussis vaccine to a patient, the health care provider shall record in a permanent record to which the patient's parent or guardian shall have access upon request: The date each dose of pertussis vaccine is administered; The manufacturer and lot number of the vaccine used for each; Other identifying information on the vaccine used; and The name and title of the health care provider who authorized the vaccine to be administered and the one who administered it. A health care provider who has administered the pertussis vaccine to a patient and who has been informed by the parent or guardian of the patient, or has reason to believe that the patient has had a major adverse reaction to pertussis vaccine, shall within 24 hours of receipt of that knowledge: Record to the extent of his knowledge all relevant information in the patient's permanent medical record; and Report information, including the manufacturer's name, date of administration, type and lot number of the vaccine, a brief description of the reaction, and other specified information on a morbidity report card, to the local health officer. These reports can also be made by telephone. Upon receipt of notification of a major adverse reaction to a pertussis vaccine, the local health officer shall: Notify and forward the morbidity report card to the Department within 24 hours; and Assure that the necessary information to fill out a “Report of Adverse Event Following Immunization” is obtained. At the time of completion, the report shall be submitted to the Department. Whenever a resident birth occurs, the Department shall promptly provide parents of the newborn child with information included in Regulation .02A(1)—(10) of this chapter. The Department shall prescribe the form and content of the information about immunizations provided to parents at times of birth and of administration of pertussis vaccine, according to Regulation .02A(1)—(10) of this chapter. Upon receipt of information regarding a major adverse reaction to a pertussis vaccine, the Department shall immediately notify the vaccine manufacturer of the following: Date of immunization; Lot number of vaccine; and Type of reaction. The Department shall establish a system to collect data from local health officers, from public and private health care providers, and from parents, on the incidence of pertussis and major adverse reactions to pertussis vaccine. This system shall be organized so that periodic revisions and updates of information and guidelines may be made. In addition, the information collected shall be sufficient for any reports required by the Department on pertussis and major adverse reactions to pertussis vaccine. On the basis of the data collected and of any other information available, the Department shall periodically revise and update: The information provided to parents at the times of birth and of administration of pertussis vaccine; The information provided to health care providers regarding pertussis immunization deferral or exemption, and all other information otherwise regarding risks and benefits to the patient and to the public; and Other pertinent information on pertussis and pertussis vaccine The Department shall report to the Centers for Disease Control (CDC) the incidence of pertussis and major adverse reactions to pertussis vaccine. The Department shall notify by mail or other means, or both, all health care providers of their responsibilities relevant to these regulations as well as other appropriate materials (for example, ACIP recommendations, parent information pamphlets, and morbidity report cards). Revisions of these and new materials shall also be distributed in the same manner. Nothing in these regulations shall be construed to affect any emergency authority of the Secretary of Health and under any other provision of law to protect the public health. Health-General Article, §§2-104(b)(1) and 18-332, Annotated Code of Maryland Effective date: May 19, 1986 (13:10 Md. R. 1156) Regulation .04 amended effective August 10, 2009 (36:16 Md. R. 1251)