Code of Massachusetts Regulations
105 CMR - DEPARTMENT OF PUBLIC HEALTH
Title 105 CMR 135.000 - Use Of Blood, Blood Components, And Derivatives For The Purpose Of Transfusion
General Requirements
Section 135.250 - Donor Immunization and Hyperimmunization

Universal Citation: 105 CMR 135.000 MA Code of Regs 135.250

Current through Register 1531, September 27, 2024

(A) Every immunization or hyperimmunization program undertaken to enhance the usefulness of the recipient's plasma for subsequent donation as whole blood or plasma shall be supervised and approved by an institutional review board established and conducted in the manner specified in 21 C.F.R. Part 312 concerning supervision of new drugs for investigational use.

(B) The selection and scheduling of the injection of the antigen, and the evaluation of each donor's clinical response, shall be by a qualified physician.

(C) Antigens used in such programs shall be either a product licensed under Section 351 of the Public Health Service Act, 42 U.S.C. § 262, for such purpose or one specifically approved by the Director, Bureau of Biologics, FDA.

(D) If there is no suitable licensed antigen, a full description of the antigen to be used should be provided to the institutional review board established pursuant to 105 CMR 135.250(A), which should be convinced of the safety of the antigen preparation and be assured that the donor will not be harmed as a result of the procedure. All antigens should be sterile, or when viable antigens are used should be free of all other infectious agents, as determined by appropriate test before use.

(E) Schedules for administration of antigen, criteria for acceptability of plasma, and anticipated results with suitable standards by the assay to be used shall be made available to the institutional review board established pursuant to 105 CMR 135.250(A) before the procedure is begun.

(F) All records concerning the antigen, the laboratory characteristics of the plasma donor, and the immunization schedule shall be retained by the blood bank for a least five years after the donor retires from the program.

(G) The selection and administration of human erythrocytes as antigens should be subject to the following additional safeguards:

(1) The erythrocyte donor must meet all the requirements intended for the safety of the recipient that apply to whole blood donors for transfusion.

(2) Aliquots of large quantities of freeze-preserved erythrocytes from donors whose blood is considered to carry a minimal risk of transfusion-transmitted diseases should be used when possible.

(H) The institutional review board established pursuant to 105 CMR 135.250(A) shall satisfy itself that all appropriate steps have been taken to minimize the likelihood that the cells to be used as antigen will transmit transfusion-transmitted diseases to the potential plasma donor or will result in the production of additional blood group antibodies.

(I) Immunized women who are to be subject to further immunization should be at least two years past menopause or have been permanently sterilized.

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