Food and Drug Regulations (C.R.C., c. 870)

• C.04.407. (1) Before beginning plasmapheresis with a donor, a fabricator shall take a blood sample from the donor to determine the plasma protein composition of the donor’s blood by means of a serum protein electrophoresis test or an equivalent test.

• (2) A blood sample shall be taken within seven days before the donor’s first plasmapheresis session at which the fabricator proceeds with plasmapheresis.

• (3) If 21 days have elapsed from the taking of the sample without a physician examining the test result, the fabricator may not proceed with plasmapheresis until a physician examines the test result.

• (4) If a physician concludes that the plasma protein composition of the donor’s blood is not within normal limits, the fabricator may not proceed with plasmapheresis until a physician determines that the plasma protein composition of the donor’s blood is within normal limits.

• (5) If the fabricator has not taken a blood sample from the donor as required under subsection (1) for more than four months, the fabricator may not proceed with plasmapheresis until the blood sample is taken from the donor.

• C.04.408. (1) A physician shall determine if a donor is suitable to continue to participate in plasmapheresis more frequently than once every eight weeks, based on the test results and collection records for the donor that have been made or received by the fabricator within the preceding four months.

• (2) The determination shall be made at least every four months after the date of the initial determination that the donor is suitable under section C.04.404.

• (3) If the donor is determined to be temporarily not suitable to participate in plasmapheresis the fabricator shall inform the donor of the reason why they are temporarily not suitable and indicate the date when the donor may continue to participate in plasmapheresis.

• (4) If the donor is determined to be not suitable for an indefinite period, the fabricator may not proceed with plasmapheresis and shall inform the donor of the reason why they are not suitable.

• (5) If the requirement of subsection (2) is not met, the fabricator may not proceed with plasmapheresis until the determination is made.

C.04.409. A fabricator who conducts a plasmapheresis session shall

• (a) use aseptic methods and a sterile collection system licensed under the Medical Devices Regulations;

• (b) ensure that all surfaces intended to come into contact with blood or plasma are pyrogen free;

• (c) ensure that the donor’s skin where the phlebotomy is to be made is

  • (i) determined to be free from lesion, rash or other source of infection, and

  • (ii) cleaned and disinfected; and

• (d) ensure that emergency medical personnel are capable of attending to the medical needs of the donor within 10 minutes after being contacted by the fabricator.