Embracing Inpatient Radiopharmaceutical Therapies in Radiation Oncology: An Example With Commissioning Pediatric I-131 MIBG Therapy

Abstract

<h3>Purpose/Objective(s)</h3> Radiopharmaceutical therapy is rapidly expanding in radiation oncology and nuclear medicine. Iodine-131 metaiodobenzylguanidine (I-131 MIBG) is an inpatient therapy involving long infusion times and special consideration for radiation exposure and contamination control. In this study, we outline our process for commissioning pediatric I-131 MIBG therapy with a multidisciplinary team and perform a failure modes and effects analysis to assess the robustness of our procedures. <h3>Materials/Methods</h3> To commission pediatric I-131 MIBG therapy, we (1) created a multidisciplinary team with the appropriate skills, (2) located a space that met the needs of this intensive inpatient therapy, and (3) developed procedures that maximized safety. We identified failure modes (FM) from room design to patient/room release and scored them (1-10) according to their risk for occurrence (O), severity (S), and lack of detectability (D), per AAPM Task Group 100. The risk-priority number (RPN) is the product of these scores and identifies the FMs with the greatest risk. <h3>Results</h3> Our multidisciplinary team includes an authorized user (radiation oncologist/nuclear medicine physician), pediatric oncologists, radiation therapists, nurses, therapy medical physicists, and radiation safety staff. The space has a dedicated restroom and shower with appropriate plumbing, shielding built into the patient room/restroom construction, appropriate ventilation/filtration, and enough space for the patient, the infusion team (3-5), equipment, and mobile shields. The procedures meet regulatory and institutional safety standards and allow for appropriate radiation exposure and contamination control. 149 FMs were identified. The FMs with the greatest RPN were related to training deficiencies: (1) training of staff was inadequate (O = 5, S = 8, D = 4, RPN = 160), (2) caregivers did not understand radiation safety training (O = 5, S = 7, D = 4, RPN = 140), and (3) saline bag line and other dose lines (if multiple vials) were not clamped properly during dose infusion (O = 4, S = 8, D = 4, RPN = 128). 36/149 (24%) FMs had a high severity (S≥7). Of those, 11 (7% of all FMs) had a moderate risk of occurrence or going undetected (O or D > 3 but < 7) and none had a high risk of occurrence or going undetected (O or D ≥7). The remaining 25 high severity FMs were associated with commissioning, training, and room design/construction (14/25); drug ordering and patient preparation (7/25); and dose infusion (4/25). We attribute these FMs' relatively low risk of occurrence or going undetected to extensive checklists and redundant procedures. <h3>Conclusion</h3> Pediatric I-131 MIBG therapy is a complex treatment that requires careful consideration during commissioning. With a properly trained multidisciplinary team, robust procedures and checklists, and appropriate resources, it can be implemented safely and effectively.