Md. Code Regs. 10.52.05.04

Current through Register Vol. 51, No. 22, November 1, 2024

Section 10.52.05.04 - Requirements of the Department

A. 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.

B. 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.

C. Upon receipt of information regarding a major adverse reaction to a pertussis vaccine, the Department shall immediately notify the vaccine manufacturer of the following:

(1) Date of immunization;

(2) Lot number of vaccine; and

(3) Type of reaction.

D. 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.

E. On the basis of the data collected and of any other information available, the Department shall periodically revise and update:

(1) The information provided to parents at the times of birth and of administration of pertussis vaccine;

(2) 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

(3) Other pertinent information on pertussis and pertussis vaccine

F. The Department shall report to the Centers for Disease Control (CDC) the incidence of pertussis and major adverse reactions to pertussis vaccine.

G. 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.

Md. Code Regs. 10.52.05.04

Regulation .04 amended effective August 10, 2009 (36:16 Md. R. 1251)