Radiation Safety Procedure

No. 2

Obtaining a Human Use Sublicense

      I.            Purpose

This procedure provides the necessary information to complete the application for a Human Use Sublicense to qualified individuals or departments within the jurisdiction of UT Southwestern, and associated hospitals, to purchase, maintain, use, and dispose of RAM for Human use.

   II.            Authorization

Only individuals or departments who have applied for and have been issued a Human Use Sublicense have the authorization to order and use RAM for the purpose of medical research, diagnostic use, or therapeutic use on the UT Southwestern Campus and associated hospitals. To qualify for a Human Use Sublicense, an individual must meet the criteria outlined in this procedure and the requirements of TRCR Appendix 41-E. The RSC reviews and approves or denies all applications for Human Use Sublicenses based on the submitted information.

A Departmental Sublicense requires the listing of a principal user who shall be the primary responsible individual in charge of the sublicense. Other users may be added to the sublicense if they meet the criteria listed in this procedure.

III.            General Criteria

The following criteria should be applied to determine which individuals or departments meet the necessary requirements and qualifications to hold a Human Use Sublicense.

A.        Any approved user shall be experienced in the handling of sources of radiation and shall meet the criteria stipulated in TRCR 41-E as follows:

1.         For uptake, dilution, and excretion studies as shown in TRCR 41-E.I.

2.         For imaging and localization studies as shown in TRCR 41-E.II.

3.         For the therapeutic use of radiopharmaceuticals as shown in TRCR 41-E.III.

4.         For use of brachytherapy sources as shown in TRCR 41-E.IV.

5.         For ophthalmic use of ⁹⁰Sr as shown in TRCR 41-E.V.

6.         For use of sealed sources for diagnosis as shown in TRCR 41-E.VI.

7.         For teletherapy as shown in TRCR 41-E. VII.

8.         For the use of RAM in tracer quantities. Occasionally studies involving the use of microcurie amounts of a tracer on a human subject may be requested by a department or by a physician that does not meet the criteria of TRCR 41-E and that is not involved with the department of Radiology. Such an application may be reviewed by the Radiation Safety Committee on a case by case basis. The RSC may approve such an application after ensuring that the protocol is acceptable from the standpoint of the patient, that the benefits far outweigh any minor risks, and that the procedure can be performed within utmost radiation safety practices. A detailed operating procedure including patient exposure, radiation risks, survey methods, and protection methods shall accompany such applications.

B.         Exemptions include physicians, dentist or podiatrists who were identified as authorized users of RAM by a Commission or Agreement State license or a Broad Scope license prior to September 1, 1993 and those issued by the Agency before October 1,1995 as required by TRCR 41-E.VIII.

IV.            Human Use Sublicense Application Procedure

Individual and departmental applicants shall complete and submit to the RSC a Human Use of Radioactive Material Sublicense Application, RSF-001 (Appendix II) or its equivalent form. The form shall contain the following information.

A.        Name of department, Group, or individual, address, mail code, phone number, name, degree, and social security number of the person with primary responsibility for the sublicense.

B.         A list of all rooms where Ram will be used or stored.

C.        A list of individuals to be authorized to use RAM under this sublicense with the following individual’s information:

1.         Physician’s Name;
2.         Degrees;
3.         Faculty Title;
4.         Phone Number;
5.         Mail Code;
6.         A copy of the Physician’s qualifications for each category requested as required in
            section III of this Procedure.

D.        The category of RAM to be used selected from the following list:

1.         Group I, uptake, dilution, and excretion (TRCR 41-B)
2.         Group II, diagnostic studies (TRCR 41-B)
3.         Group III, preparations of radiopharmaceuticals for diagnostic studies (without
             generators) (TRCR41B)
4.         ¹³³Xe
5.         DTPA Aerosols
6.         Therapeutic Radiopharmaceuticals
7.         Brachytherapy Sources
8.         Sealed Sources for Diagnosis
9.         Material not previously listed (Investigational drugs, generators)

E.         A list of all non-exempt sealed sources to be used.
F.         A detailed description of each procedure, other than those in Groups I, II, and III, to be
             performed which uses RAM shall be submitted and shall include:

1.         Type of procedure;
2.         The radioisotope to be used;
3.         Approximate activity per procedure;
4.         Location where procedure will be performed if not in room listed on license;
5.         Number of procedures performed per individual;

G.        A description of the radiation safety hazards that these procedures may produce and the methods to be used to minimize those hazards shall be included, i.e.:

1.         protective shielding,
2.         surveys,
3.         storage methods.

H.        List the forms and types of waste expected to be produced from these procedures and the methods of disposal.

In addition a Radioactive Room Use Application, RSF-005a (Appendix I-2) or an equivalent form shall be submitted to the RSC. A diagram of the laboratory or rooms to include storage location, RAM use areas, waste storage locations, and all isotopes to be used or stored in the room shall be included on this form.