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Regulatory Affairs - Statute and Regulations


I. General provisions (Sec. 3100).

II. Regulation of the business of blood donating (Secs. 3120-3122).

III. Blood donors of the age of eighteen years or over (Secs. 3123-3124).


Sec. 3100. Human blood and its derivatives; collection, processing, storage and distribution; general powers of commissioner.

Sec. 3100. Human blood and its derivatives; collection, processing, storage and distribution; general powers of commissioner.

1. The commissioner is hereby authorized:

(a) to establish, equip, maintain and conduct a suitable program to collect, process, store and distribute human blood, and the various human blood derivatives including special therapeutic and diagnostic serums, which are deemed of value in the treatment of sick and injured persons, and the prevention of certain diseases;
(b) to carry out such educational and research activities as he may deem necessary in connection with said program; and
(c) to establish necessary rules and regulations to effect the purpose of this article.

2. The commissioner may conduct such program solely as a state activity, or in cooperation with such institutions, hospitals or municipal corporations as he may select, on such terms as may be agreed upon.

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Sec. 3120. Blood collection; permit required; procedure. No person, firm or corporation shall collect human blood for the purpose of transfusion into another human being unless a permit has been issued pursuant to the provisions of title five of article five of this chapter.

Sec. 3121. Council on human blood and transfusion services.

1. There is hereby created in the department a council on human blood and transfusion services, hereinafter known as the "council," to consist of the commissioner and eight other members appointed by the governor, with the advice and consent of the senate, one of whom shall be a representative of the public. The remaining appointive members shall have had experience or training having rendered them knowledgeable in the various aspects of blood banking services, and may include but shall not be limited to, representatives of voluntary and commercial blood banks, representatives of hospitals, and physicians. The governor shall designate one member to serve as chairman.

2. The term of office of each appointive member of the council shall be for three years, provided, however, that of the members first appointed, three shall be appointed for terms which shall expire on December thirty-first, nineteen hundred seventy-four, three for terms which shall expire on December thirty-first, nineteen hundred seventy-five and two shall be appointed for terms which shall expire on December thirty-first, nineteen hundred seventy-six. Vacancies shall be filled by appointment for the unexpired term. The appointive members shall continue in office until the expiration of their terms and until their successors are appointed and have qualified.

3. The council shall meet as frequently as its business may require. The members of the council shall receive no compensation for their services as members of the council, but each of them shall be allowed the necessary and actual expenses which he shall incur in the performance of his duties under this section.

4. The commissioner, upon request of the council, shall designate an officer or employee of the department to act as secretary of the council, and shall assign from time to time such other employees as the council may require.

5. The council shall have power by the affirmative vote of a majority of its members to enact, and from time to time, amend and repeal, rules and regulations establishing minimum standards for the proper collection, processing, fractionation, storage, distribution, and supply of human blood or blood derivatives, for the purpose of transfusions, subject to approval by the commissioner.

Sec. 3122. Blood donating; violations; penalties. Any violation of sections three thousand one hundred twenty and three thousand one hundred twenty-one, of this chapter, shall constitute a misdemeanor, punishable on conviction by a fine of not exceeding fifty dollars or by imprisonment for not exceeding six months, or both such fine and imprisonment.

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Sec. 3123. Blood donors of the age of seventeen years or over. Any person of the age of seventeen years or over shall be eligible to donate blood in any voluntary and non compensatory blood program without the necessity of obtaining parental permission or authorization.

Sec. 3124. Reporting system for hospitals and blood banks. All persons, firms and corporations engaged in procuring blood donations shall report annually the following information to the commissioner of health:

a. The amount of whole blood collected.
b. The amount fractionated.
c. When fractionated.
d. How much blood is unused and destroyed.
e. How much blood is converted and what is it converted into.
f. Any other information the commissioner finds necessary to have an accurate picture of what happens to collected blood within the state.
The commissioner shall make such rules and regulations as are necessary to create an accurate and complete reporting system. Back to Top