Food and Drug Regulations

C.04.410 (1) A sample of blood shall be drawn from each donor within the seven-day period prior to the donor’s first plasmapheresis in a plasmapheresis program and not less frequently than every three months thereafter for so long as the donor continues on the program

• (a) by a practitioner; or

• (b) under the supervision of a practioner, by a person trained for that purpose.

(2) Every sample drawn pursuant to subsection (1) shall be tested by

• (a) a laboratory test for syphilis; and

• (b) a serum protein electrophoresis test, a quantitative immunodiffusion test, or another test made by an acceptable method to determine the serum protein components.

• (c) [Repealed, SOR/85-1022, s. 5]

(3) Within 14 days after a sample is drawn pursuant to subsection (1), results of the tests specified in subsection (2) shall be reviewed by a practitioner.

(4) Where the test referred to in paragraph (2)(a) is reactive for syphilis, plasmapheresis shall not be carried out again on the donor until the donor’s serum proves nonreactive to a laboratory test for syphilis.

(5) Where the test referred to in paragraph (2)(b) shows the plasma protein composition of a donor not to be within normal limits, the donor shall be removed from the plasmapheresis program until those values return to normal.