Food and Drug Regulations

C.04.406 (1) A donor who has been provided with a signed certificate pursuant to section C.04.404 shall, on the day that plasmapheresis is to be carried out on him, be interviewed and evaluated by a practitioner or, under the supervision of a practitioner, by a person trained for such a purpose, to ensure that the donor is in good health and, without restricting the generality of such interview and evaluation, to ensure that the donor:

• (a) has not donated whole blood within the previous eight weeks;

• (b) has a normal temperature;

• (c) is free from

  • (i) infection, including any infectious skin disease at the site of phlebotomy, and

  • (ii) any disease generalized to such an extent as to create a risk of contamination of the human plasma;

• (d) is free from any disease transmissible by blood transfusion;

• (e) is free from skin punctures or scars on the arms and forearms indicative of drug addiction;

• (f) has a blood pressure within normal limits;

• (g) has a

  • (i) blood hemoglobin level of not less than 125 grams per litre of blood if the donor is female or 135 grams per litre of blood if the donor is male, or

  • (ii) a hematocrit value of 0.38 litre/litre of blood if the donor is female or 0.41 litre/litre if the donor is male;

• (h) has a total serum protein of not less than 60 grams per litre of serum;

• (i) weighs at least 40 kilograms;

• (j) has no history of viral hepatitis;

• (k) has not, within the last six months, been in close contact with an individual suffering from viral hepatitis; and

• (l) has not, within the last six months, received human blood or any derivative of human blood that is a possible source of viral hepatitis, except for specific immunization performed in accordance with section C.04.403.

(2) Notwithstanding paragraph (1)(a), a donor may donate plasma within eight weeks of a previous donation of whole blood, provided he is examined by a practitioner and that practitioner certifies that the donor otherwise meets the criteria in subsection (1) and that the donor may donate plasma.