§ 35.22 - Radiation Safety Committee.  


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  • Each medical institution licensee shall establish a Radiation Safety Committee to oversee the use of byproduct material.

    (a) Each Committee must meet the following administrative requirements:

    (1) Membership must consist of at least three individuals and must include an authorized user of each type of use permitted by the license, the Radiation Safety Officer, a representative of the nursing service, and a representative of management who is neither an authorized user nor a Radiation Safety Officer. Other members may be included as the licensee deems appropriate.

    (2) The Committee must meet at least quarterly.

    (3) To establish a quorum and to conduct business, at least one-half of the Committee's membership must be present, including the Radiation Safety Officer and the management's representative.

    (4) The minutes of each Radiation Safety Committee meeting must include:

    (i) The date of the meeting;

    (ii) Members present;

    (iii) Members absent;

    (iv) Summary of deliberations and discussions;

    (v) Recommended actions and the numerical results of all ballots; and

    (vi) ALARA program reviews described in § 35.20(c).

    (5) The Committee must promptly provide each member with a copy of the meeting minutes, and retain one copy for the duration of the license.

    (b) To oversee the use of licensed material, the Committee must:

    (1) Review recommendations on ways to maintain individual and collective doses ALARA;

    (2)(i) Review, on the basis of safety and with regard to the training and experience standards in subpart J of this part, and approve or disapprove any individual who is to be listed as an authorized user, an authorized nuclear pharmacist, the Radiation Safety Officer, or a teletherapy physicist before submitting a license application or request for amendment or renewal; or

    (ii) Review, pursuant to § 35.13 (b)(1) through (b)(4), on the basis of the board certification, the license, or the permit identifying an individual, and approve or disapprove any individual prior to allowing that individual to work as an authorized user or authorized nuclear pharmacist;

    (3) Review on the basis of safety, and approve with the advice and consent of the Radiation Safety Officer and the management representative, or disapprove minor changes in radiation safety procedures that are not potentially important to safety and are permitted under § 35.31 of this part;

    (4) Review quarterly, with the assistance of the Radiation Safety Officer, a summary of the occupational radiation dose records of all personnel working with byproduct material;

    (5) Review quarterly, with the assistance of the Radiation Safety Officer, all incidents involving byproduct material with respect to cause and subsequent actions taken; and

    (6) Review annually, with the assistance of the Radiation Safety Officer, the radiation safety program.