10.9 Written Directives

Patient-specific (or human subject-specific) written orders stating the following information are required by regulation for:

  • The administration of external beam therapy, (particle accelerator or X-ray).  Each written order must indicate the total prescribed dose, the dose per fraction, the treatment site, and number of fractions.
  • The administration of external beam, gamma stereotactic radiosurgery.  Each written order must indicate the target coordinates, collimator size, plug pattern, and the total prescribed dose.
  • The administration of high-dose-rate remote afterloading brachytherapy (HDR).  Each written order must indicate the radionuclide, the treatment site, and the total prescribed dose.
  • The administration of brachytherapy, excluding HDR.  Each written order must indicate the radionuclide, and the number and activity of sources to be implanted.  Following source implantation and prior to completion of the brachytherapy procedure, each written order must specify the radionuclide, the treatment site, and total prescribed dose (or, equivalently, the total source strength and exposure time).
  • The therapeutic administration of a radiopharmaceutical other than sodium iodide I-131.  Each patient-specific written order must state the prescribed radiopharmaceutical, dosage, and route of administration.

Each written directive required by regulation must be signed and dated by an authorized user prior to patient administration.  Copies of written directives shall be maintained on file for inspection.