Food and Drug Regulations

C.04.409 (1) The skin of a donor at the site of phlebotomy shall be prepared thoroughly and carefully by a method that gives maximum assurance of a sterile container of blood.

(2) The blood of the donor shall be collected, the human plasma shall be separated and the red blood cell suspension shall be returned to the donor by aseptic methods in a sterile collection system.

(3) All surfaces that come in contact with blood or human plasma shall be both sterile and pyrogen-free.

(4) Equipment and waste materials contaminated with blood or human plasma shall be removed immediately following usage for incineration or disinfection.

(5) Any spillage of blood or human plasma shall be treated as a potential source of infection and the area shall be decontaminated immediately.