Radiation Safety Office

CHAPTER 6
PROCUREMENT AND USE OF RADIOISOTOPES

6.1 RADIOISOTOPE PROCUREMENT PROCEDURES

The Radiation Safety Office maintains a database of Authorized Users of radioisotopes. This list includes the radioisotopes and maximum amounts that each User is authorized to possess and the maximum amount of activity that may be purchased on a single order. Only Authorized Users may order or possess radioisotopes.

The procedures for acquisition of radioactive material under University licenses are as follows:

Each Authorized User ordering radioisotopes under the University licenses must fill out a purchase requisition form, and then forward this form to the Radiation Safety Office. Upon approval by the Radiation Safety Office, the requisition will be forwarded to the appropriate purchasing department. The purchasing department will not honor any requisition for radioactive material without the approval of the Radiation Safety Office. All package receipts of radioactive material must be routed through and received by the Radiation Safety Office. This includes shipments destined to outlying locations such as the Hillman Cancer Center, W.P.I.C., Children's Hospital, Magee Women's Hospital, etc. Any exception to this rule must be approved by the Radiation Safety Office.
An Authorized User who wishes to order, possess, and handle radioisotopes in excess the limits of his authorization must submit a written amendment to the Radiation Safety Office prior to placing the order.
Blanket orders for radioisotopes will be approved under the same procedures as outlined in Paragraph 1. All radioisotopes ordered under a blanket order must be shipped directly to the Radiation Safety Office. Free samples, unusual order circumstances, or new compounds offered gratis containing radioactive material accepted by researchers must also enter the University through this office for inventory update and radiological control surveys, as necessary. Exceptions to this rule must be approved by the Radiation Safety Officer.
The Authorized User's name must appear on purchase requisitions to assure proper inventory control and delivery.

Receipts containing quantities of radioactive material in excess of limits specified in 10CFR20 must be surveyed by the Radiation Safety Office. All packages are subject to safe opening procedures. All radioactive materials receipts are entered into the Radiation Safety data bases and all Authorized Users are required to submit updated inventories to the Radiation Safety Office on a quarterly basis.

6.2 TRANSFER OF ISOTOPES AND RADIATION SAFETY RESPONSIBILITY

No radioactive material or responsibility thereto can be transferred to another person who is not an Authorized User of radioisotopes. An Authorized User should not transfer radioactive material to another Authorized User without the knowledge and approval of the Radiation Safety Office. This includes any sale or transfer from the Medical Center to a University researcher or clinician. Once approval is obtained, the transfer is to be documented using an "Internal Radioisotope Transfer Form" available from the Radiation Safety Office or in the forms section of the Office web site..

When radioisotopes are to be transferred to another facility or person not regulated by the University of Pittsburgh's licenses, proof of possession of a valid NRC or State nuclear materials license must be obtained prior to the transfer. All such transfers must be made by the Radiation Safety Office.

6.3 EXTENDED LEAVES AND TERMINATIONS

Persons taking extended leaves, such as sabbatical leave or for illness, who intend to have research or studies using radioactive material continue during their absence, must designate a qualified co-worker or preferably another Authorized User to assume radiation safety responsibility during their absence. The Radiation Safety Office must be informed of and approve this delegation of responsibility.

Persons terminating their use of radioactive materials must notify the Radiation Safety Office in writing at least one month prior to the termination. All radioactive materials must be turned over to the Radiation Safety Office and the laboratories must be surveyed and down-posted prior to returning them to general use. If the Authorized User intends to transfer radioactive materials to another institution, the Radiation Safety Office has the responsibility to package and transfer the radionuclides. If laboratory equipment used in conjunction with radioactive materials is to be transferred to another institution, then the Radiation Safety Office must certify the equipment as free of radioactive materials prior to packing and shipping.

The Radiation Safety Office of the receiving institution must be notified in advance and approve of the shipment.

6.4 HUMAN USE

6.4.1 General
All uses of ionizing radiation are regulated under Federal (10CFR35) or Commonwealth (x ray uses and nuclear materials) regulations. These uses include uptake, dilution and excretion studies; imaging and localization studies, unsealed source radionuclide therapy, brachytherapy and both x ray and radionuclide teletherapy.

Only those radiopharmaceuticals which have either IND or NDA approval from the FDA may be routinely used. All other radiopharmaceuticals must have RDRC approval.

6.4.2 Diagnostic and Therapeutic Uses

Policies and procedures related to the administration of radiopharmaceuticals must be approved by the Radiation Safety Officer.

Written directives (an Authorized User’s written order for the administration of ionizing radiation to a specific patient or human research subject, as specified in 10CFR35.40) are required for all therapeutic uses of ionizing radiation and for the administration of ¹³¹I in quantities exceeding 30 microcuries. Specific procedures must be followed for administrations requiring a written directive, 10CFR35.41.

Patients treated with therapeutic quantities of nuclear materials shall be treated either as in-patients or out-patients in accordance with 10CFR35 requirements and their medical needs. Only sealed sources as approved in the Sealed Source and Device Registry or in accordance with an IDE application accepted by the FDA may be used for therapeutic purposes.

6.4.3 Medical Events

All "medical events", as defined in 10CFR35, Subpart M or in Title 25, Environmental Protection must be reported to the Radiation Safety Office immediately upon identification. Any notifications necessary to either the NRC or Commonwealth will be made by the Radiation Safety Office.

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Revised February 9, 2001