Stakeholder Model for Standard Operating Procedure of Radiation Safety Practice in Radiopharmaceutical Therapy.

PURPOSE/OBJECTIVE(S): Using Xofigo procedure as an example of radiopharmaceutical therapy, to provide a quantitative analysis methodology for standard operating procedure development with binary stakeholder model.

MATERIALS/METHODS: A Xofigo procedure was selected for this study. After nurse places the intravenous (IV) pole and start delivery of the saline liquid into the patients for required temporal period, calibrated Xofigo syringe will be transported into the treatment room by medical physicist and authorized radiation oncologist starts injecting the Xofigo liquid into the patient through the 3-way stopcock. During this process, the status of liquid path is from the syringe with Xofigo liquid to patient, and the saline liquid tube is shutoff. After about 1 minutes of injection, which most of the Xofigo radioactive liquid is injected into patient side, the 3-way stopcock will shut off the connection between the patient and syringe. The saline liquid then is abstracted into in the syringe from the saline bag hung on the IV pole, the liquid amount will be used for diluting the residual Xofigo liquid inside the syringe. Then the 3-way stopcock switch is switched off the connection between the saline bag and the syringe, and syringe is connected to the patient side again, then the saline liquid inside the syringe is injected into patient, and this process dilutes the residual Xofigo radioactive liquid at the inside surface of the syringe and the path to the patient. This dilution process could repeat a few times, depends on the estimation of residual amount. Then the syringe will be unscrewed from the 3-way stopcock by opening the path from the saline bag to the patient. At this moment, the saline is switched off from outside by cutting the tube with a scissor or unscrewed from the 3-way stopcock. A binary stakeholder quantitative model was used to evaluate the last step with a computational simulation program the tube cut-off process.

RESULTS: Based on the numerical results from the simulation program, at the best situation, if the residual isotope liquid had been diluted completely, the radiative dose to both procedures would not be different, and the only difference is the tool used and workload dispatch to both medical physicist and radiation oncologist. And at the worst scenario, there were some radioactive residuals had gone into the IV-saline tube, then the radioactive contamination could be in the scissor, both side of cut off tube, and potential contacting point will increase to two stakeholders, one more tool(scissor), which could be treated as a stakeholder.

CONCLUSION: The optimization principle could be simplified as to decrease the contacting point and contacting stakeholders by a computational simulation of a stakeholder model for a Xofigo radiopharmaceutical procedure. The analysis methodology could expand to all the steps in radiopharmaceutical therapy in developing a standard operating procedure and other complex radiation safety practice simulation system.