What threshold is used to make that determination?
“Patient intervention” is defined in § 35.2 as “actions by the patient or human research subject, whether intentional or unintentional…” and examples are provided in the definition, for guidance as to when patient intervention has occurred. Section 35.3045(b) indicates when the consequences of patient intervention are serious enough for the event to be reported as a “medical event.” b) Per § 35.3045(b), if intervention of a patient or human research subject in the administration of byproduct material or radiation from byproduct material results or will result in unintended permanent functional damage to an organ or a physiological system, as determined by a physician, the event is reportable to NRC as a “medical event.” Even though the threshold for reporting medical events is high, licensees are expected to continue to act reasonably, in accordance with prevailing standards of care, to prevent medical events caused by intervention of patients or human research subjects. Refer to “Su
Related Questions
- What work classification should be used under the weatherization wage determination for installation of a hot water heater during a weatherization project?
- Can H0002, MH Screen be used for the Intensity of Needs Determination that is required every 90 days?
- Must a prevailing wage rate determination be used if the low bid is below the minimum threshold?
