TABLE 4.

Summary of FMEA performed by Younge et al. ⁸⁸ for each step of ⁹⁰Y microsphere therapy.

Failure mode	Cause	Clinical impact
1. Pre‐treatment imaging
scheduling the incorrect microsphere type	typographic error inadequate experience/training of the AU and/or IR	major delay of patient treatment
insufficient information on the planning study
incorrect measurement/recording of lung shunt fraction (LSF)		lung toxicity or incorrect identification of patient as ineligible
incorrect target identified		under‐dosing or missing the target
2. Treatment planning
dosimetry worksheet error	inadequate experience/training typographic errors	patient toxicity tumor under‐/over‐dosing
treatment volume measured/recorded incorrectly
incorrect dose range used for cirrhotic/non‐cirrhotic patient
incorrect LSF entered in dosimetry worksheet
previous treatment not considered		patient toxicity
gastrointestinal shunt not considered/recorded incorrectly
planning performed for wrong type of microspheres		patient toxicity tumor under‐/over‐dosing major delay to the patient's treatment
3. Dosage Ordering
dosage not ordered or ordered late	delays in planning communication error	major delays to the patient's treatment
incorrect delivery date/time or incorrect requested calibration date/time	inadequate experience/training typographic errors
incorrect order form submitted
incorrect type of microspheres ordered
4. Dosage Preparation
incorrect assay date/time recorded on check‐in paperwork	inadequate experience/training typographic errors	patient toxicity tumor under‐/overdosing
incorrect infusion date/time recorded on check‐in paperwork
incorrect dose calibrator factor used for assay
incorrect patient dosimetry worksheet used
not using aseptic techniques when assaying/preparing dosage
5. Treatment administration
wrong patient	inadequate experience/training typographic errors communication error	patient toxicity tumor under‐/overdosing
catheter incorrectly placed (i.e., wrong site)
incorrect vial/dose used
kinks/resistance/clogs in administration catheter after treatment initiation	inadequate experience/training
vendor‐specific instructions not followed for administration
lung shunting not verified pretreatment	inadequate experience/training communication error	patient toxicity
system disconnection (lines disconnecting, needles pulled out of vial, etc) during or after administration		patient toxicity tumor under‐/overdosing radioactive contamination of area (additional exposure to staff, patient and delay for cleanup)