Section 3725.05. Federal requirements for collection of plasma

No plasmapheresis center shall be certified by the director of health unless all federal requirements for the collection of plasma by plasmapheresis under the "Public Health Service Act," 58 Stat. 682 (1944) 42 U.S.C. 201, as amended, are met and:

(A) A test approved by the director of health for hepatitis B antigen is made on a sample of blood taken from the donor at the time of blood collection.

(B) No person who has ever shown a positive test for hepatitis B antigen or who has a history of hepatitis serves as a donor for plasma, with the exception of plasma intended for special purposes approved by the director of health;

(C) A qualified licensed physician, known as the medical director, is responsible for compliance with this chapter and rules adopted thereunder, and for maintaining the health and safety of participants in the plasmapheresis procedure.

(D) A licensed physician, a registered nurse, or a medical technologist approved by the director of health is in attendance at all times when a donor is undergoing plasmapheresis, and is responsible for supervising the procedure and the maintenance of sterile technique;

(E) Handwashing facilities are present in the room where the blood is drawn and in the room where the formed elements are separated from the plasma.

Effective Date: 09-19-1975