Sec. 10.52.05.02. Requirements for Health Care Providers

A. Before the administration of pertussis vaccine, the health care provider shall provide to the patient's parent or guardian written information addressing:

(1) The frequency, severity, and potential long-term effects of pertussis;

(2) Possible adverse reactions to pertussis vaccine, which, if they occur, should be brought to the immediate attention of the health care provider;

(3) 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;

(4) Measures parents should take to reduce the risk of, or to respond to, any major adverse reaction to pertussis vaccine;

(5) Early warning signs or symptoms to which parents should be alert as possible precursors to a major adverse reaction to pertussis vaccine;

(6) When and to whom parents should report any major adverse reactions to pertussis vaccine;

(7) A summary of the immunization requirements adopted under Education Article, §7-402(a), Annotated Code of Maryland, including those related to pertussis vaccine;

(8) The circumstances under which pertussis vaccine may not be administered;

(9) The circumstances under which administration of pertussis vaccine shall be delayed; and

(10) Categories of potential recipients who are significantly more vulnerable to major adverse reactions to pertussis vaccine than is the general population.

B. 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:

(1) Pertussis vaccine should not be administered to the patient;

(2) Administration of pertussis vaccine should be delayed; or

(3) 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.

C. 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.

D. 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.

E. 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.

F. 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:

(1) The date each dose of pertussis vaccine is administered;

(2) The manufacturer and lot number of the vaccine used for each;

(3) Other identifying information on the vaccine used; and

(4) The name and title of the health care provider who authorized the vaccine to be administered and the one who administered it.

G. 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:

(1) Record to the extent of his knowledge all relevant information in the patient's permanent medical record; and

(2) 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.