Each institution licensed by the Nuclear Regulatory Commission (NRC) is required to maintain a Quality Management Program (QMP) intended to result in no significant errors (zero error tolerance) in the use of radioactive compounds. This program is the responsibility of the radiation safety committee and the radiation safety officer for the institution.
In order to prevent significant errors from happening, the QMP should include requirements for:
(1) a written directive before any exposure
(2) positive patient identification using at least 2 different methods
(3) verification that the plan of treatment and calculated exposures agree with the written directive
(4) verification that each administration is in accord with the written directive
(5) identification of all unintended deviations from the written directive
If events occur that meet criteria for a misadministration, the licensee must:
(1) notify the NRC verbally within 24 hours and in writing within 15 days of the event occurrence
(2) notify the patient's physician similarly
(3) if the patient can safely receive the information, then the patient should also be similarly notified; if informing the patient would be medically harmful or if the patient is unable to receive the information, then a relative or friend of the patient should be similarly notified
If the administered dose differs by less than the reportable limit, then the licensee is required to respond to the problem internally. The larger deviations need to be reported since this could indicate a deficiency in the Quality Management Program rather than representing a significant risk to the patient.
Definitions for Misadventures
All diagnostic radiopharmaceuticals, including sodium I-125 or I-131 at less than 30 µCi (NOTE: assume NaI equal to 30µCi also included here):
(1) recordable events:
(1a) none
(2) misadministration:
(2a) wrong patient, AND dose > 5 rem effective dose equivalent or > 50 rem to organ
(2b) wrong radiopharmaceutical , AND dose > 5 rem effective dose equivalent or > 50 rem to organ
(2c) wrong route, AND dose > 5 rem effective dose equivalent or > 50 rem to organ
(2d) wrong dosage, AND dose > 5 rem effective dose equivalent or > 50 rem to organ
Sodium iodide radiopharmaceuticals, greater than 30 µCi sodium I-125 or I-131:
(1) recordable events:
(1a) administered dose differs by more than 10% from the prescribed dosage, AND > 15 µCi
(1b) administered without written directive
(1c) administered without daily dosage record
(2) misadministration:
(2a) wrong patient
(2b) wrong radiopharmaceutical
(2c) administered dosage differs by more than 20% from the prescribed dosage AND > 30 µCi
Therapeutic radiopharmaceuticals:
(1) recordable events:
(1a) administered dosage differs by more than 10% from the prescribed dosage
(1b) administered without written directive
(1c) administered without daily dosage record
(2) misadministration:
(2a) wrong patient
(2b) wrong radiopharmaceutical
(2c) wrong route of administration
(2d) administered dosage differs by more than 20% from the prescribed dosage
Teletherapy:
(1) recordable events:
(1a) calculated weekly dose 15% greater than prescribed dosage
(1b) administered without written directive
(1c) administered without daily dosage record
(2) misadministration:
(2a) wrong patient
(2b) wrong mode of treatment
(2c) wrong treatment site
(2d) calculated weekly dose 30% greater than prescribed dose
(2e) calculated total dose differs by more than 20% from the total prescribed dose
(2f) if < 3 fractions, calculated total dose differs by more than 10% from the total prescribed dose
Brachytherapy:
(1) recordable events:
(1a) calculated weekly dose 10% greater than prescribed dosage
(1b) administered without written directive
(1c) administered without daily dosage record
(2) misadministration:
(2a) wrong patient
(2b) wrong radioisotope
(2c) wrong treatment site
(2d) leaking source
(2e) failure to remove sources for a temporary implant
(2f) calculated administered dose differs by more than 20% from the prescribed dose
Gamma stereotactic radiosurgery:
(1) recordable events:
(1a) administered without written directive
(1b) administered without daily dosage record
(2) misadministration:
(2a) wrong patient
(2b) wrong treatment site
(2c) calculated total administered dose differs by more than 10% from the total prescribed dose
Specialty: Hematology Oncology
