Ordering of Routinely Used Material

The immediate approval of a purchase order for radioactive material is delegated by the Nuclear Medicine Physician to the Nuclear Medicine Technologist or by the Radiation Oncologist to the Medical Physicist or Dosimetrist.  The Nuclear Medicine Physician or Radiation Oncologist must be authorized by the University Radiation Safety Committee to use radiopharmaceuticals for human use and such uses must be reviewed by the Radiation Safety Officer (RSO).  The Nuclear Medicine Technologist, medical physicist or dosimetrist is responsible for the inventory of all radioactive material used routinely.  Radioactive materials will be procured from NRC or Agreement State licensed suppliers.

Quality Management (e.g., Therapeutic Uses or I-131, I-125 >30 uCi)

1. A written directive will be obtained from the physician who will perform or oversee the procedure.  The written directive will contain the isotope, total prescribed dose and signature and date of authorized user.
2. Persons ordering the material will reference the physician's written request when placing the order.  The  physician's request will indicate isotope, compound, activity level, patients name, etc.
3. The physician's written request will be referenced when receiving, opening, or storing the radioactive material.
4. It is essential that written records be maintained for all ordering and receipt procedures.
5. Appendix C will serve as a model for ordering and receiving radioactive material.

Receipts, Unpacking and Storage

Receipts, Transfers, Unpacking and Storage Radioactive materials are normally delivered to the Nuclear Medicine Hot Laboratory during working hours.  On off duty hours, the packages are received as per Appendix C-2.

All personnel involved with the receipt of radioactive material shipments must be instructed in the proper procedures and precautions.  Appendix C-2 is a model for written instructions for this purpose.  A copy of these instructions is to be given to all involved individuals.

Unpacking of radioactive material receipts must be done in accordance with the established safety procedures described on Appendix D.  A copy of these procedures must be kept posted in the nuclear medicine area.

When a written package radiation survey is needed (or required by 902 KAR 100.019 Section 28, an entry should be made in a receipt log as described in Appendix D.

Records

Each clinical area is responsible for maintaining the master record file or log of all radioactive material ordered, received, transferred, used and disposed.  The Nuclear Medicine Technologist, Medical  physicist or Dosimetrist will maintain these records under the supervision of the Radiation Safety Officer.  Records of radiation surveys, incident reports, personnel dosimetry results, leak tests, and survey instrument calibration shall also be maintained in each clinical area.

The following records must be kept and are to be available for inspection at any time by the Radiation Safety Office and authorized regulatory agency representatives.

1. Type and amount of radionuclides on hand.
2. Results of radiation surveys.
3. Sealed source leak tests and inventories, dose calibrator quality control testing, and survey meter calibrations control testing, and survey meter calibrations.
4. Method and amount of disposal, including radiation survey results for material held for decay.
5. Patient dose records, including patient's name dose prescribed, dose assayed, type of procedure, and date.  Records will be retained for review by the licensing body for the periods specified below.
   1. Indefinitely:
      • Personnel Monitoring and Bioassay Records
      • Radiation Accident Investigation Results
      • Radiation Safety Committee Minutes
   2. 10 Years:
      • Misadministration Reports
   3. 5 Years:
      • Sealed Source Leak Test and Inventory Results
   4. 3 Years:
      • Patient Dose Records
      • Survey Results, Including Area Surveys and Hold For Decay Surveys
      • Mo-99 Breakthrough Results
      • Survey Meter Calibration and Dose Calibrator QC Test Results