Incidents reported to the FANC: Review and conclusions Brussels, September 3 rd 2010 Karen Haest Health Protection

2007: Working group « Notification » Objective: The development of guidelines with regard to the modalities and criteria for the declaration to the FANC of all significant events in the field of radiation protection in radiotherapy WHAT SHOULD BE DECLARED, BY WHOM, WHEN AND HOW?

October 2008 Online report form address

Incidents reported: Review Since the publication of the guidelines, 8 adverse events in the field of radiotherapy were reported to the Agency (6 through the online report form): 2008: : : 2 Event place: 3 (5) university hospitals and 3 general hospitals Reporter: Head of the RT department: 4 Physicist: 2 Recognized Body (AV ControlAtom): 2 Type of event: Patient related issues: 4 Environmental related issues: 3 Personnel related issues: 1 (medical device related issues) Delay of notification (guidelines: not more than 2 working days after detection): One day: 1 Within one week: 3 Within two weeks: 3 Within one month: 1

1.Inversion of 2 lots of I-125 seeds 2.Loss of 1 Iridium-192 wire 3.Loss of 3 Iridium-192 wires 4.Patient identification error: switch of two IMRT patients with the same name 5.Accidental irradiation of a radiation nurse 6.Uncontrolled evacuation/transport of possibly contaminated I-131 filters 7.Multiple isocentre mistreatment 8.Patient identification error: two extra AP/PA fields from the next patient Incidents reported: Review

Loss of three Iridium-192 wires (1/4) –The patient, treated for a sarcoma, was discharged in his room on a Sunday. –The radioactive sources were the same day transported to the hot lab in the radiotherapy department by an auxiliary nurse. –Instead of placing the wires in a big fixed container (before final storage), the nurse placed the wires in a little mobile container used for the transportation of sources to and from the operating theatre. –8 days later, the RT department noticed the disappearance of the sources.

Inquiry of the Agency –Multidisciplinary inspection team: 1 physician, 1 engineer expert in radiation protection, 1 radiation physicist –In close collaboration with the hospital: head of the RT department, Health Physics service, Medical Physics team, the personnel of the hospital ward and operating theatre, … –Scope of the visit: Handling of radioactive sources and Ir-192 wire stock Allocation of the different roles in the hospital with respect to brachytherapy with Ir-wires Visit of the hot lab, hospital ward, operating theatre, … Interrogation of the personnel involved Dosimetry of the personnel … Loss of three Iridium-192 wires (2/4)

Observations  Absence of written procedures with respect to handling of Ir- wires  An insufficient tracking of the handling of the wires by each (intermediary) person  Absence of dosimetry for certain members of the personnel working in the operating theatres and charged with the transportation of radioactive sources  Violation of instructions: manual transportation of radioactive sources without mobile containers  Absence of training and education of the personnel charged with the transportation of radioactive sources  An emotional context that favors errors (a feeling of insecurity in the hall ways and empty rooms of a RT department on a Sunday morning) Loss of three Iridium-192 wires (3/4)

Actions taken Immediate : –Search of the hospital –Measurements of the daily produced hospital waste –Analysis the laundry pathway and measurement of the industrial laundry –Analysis of the pathway of the hospital dish meals –« Yellow » hospital waste: measurement at the gate of the incinerator –« Grey » hospital waste: Measurement of the remains of the incinerations Measurement of the remains already exported to the Netherlands Long-term : –Working group (hospital/FANC) Written Ir-192 protocol (roles, responsibilities, traceability source handling, …) Loss of three Ir-192 wires (4/4)

Switch of IMRT patients (1/3) –A patient (prostate cancer) received one fraction of the treatment of another patient (head and neck cancer) with the same last name. –The fact that the patient was positioned correctly, that the irradiated volume was relatively the same and that the error was limited to only one fraction of the patients’ treatment, it is not likely that the event would have a severe impact on the patients' health or effectiveness of the entire treatment. –The error was discovered when the print-out from the R&V system at the treatment console was checked after irradiation. –Immediate corrective action: The selection of patients in the R&V system by name only was made impossible.

Switch of IMRT patients (2/3) Inquiry of the Agency –Multidisciplinary inspection team: 1 engineer expert in radiation protection, 1 radiation physicist –Scope of the visit: Analysis of the R&V system and the current working procedure Visit of the treatment console Medical aspects Communication aspects … –Observation: need for effective patient identification procedures and treatment charts (photographs, …) –Action: Long term corrective measures

Switch of IMRT patients (3/3) Long term corrective measures taken by the hospital: –Insertion of a digital photograph of the patient in the scheduling system; –Creation of an individual patient identification card with a unique barcode. Treatment will only begin when the barcode is read and electronically corresponds with the code linked to the treatment prescription. Communication: –The patient was informed by the attending physician; –The event was published on the hospitals website; –The Agency informed all other RT departments of the event with a notification letter; –The Agency also asked the Federal Agency of Medicine and Health Products (FAMHP) to urge the manufacturers of radiation therapy machines to look into the problem of patient identification errors and to investigate possible solutions at the base.

Humans are liable to make a mistake, even in the best organizations These human errors must be seen as consequences rather than causes Causes of incidents are often deep-rooted in the system “people – machines – organization”: Absence of written procedures Inadequate or poorly understood procedures Insufficient training and/or education, or lack of supervision Unclear allocation of roles and responsibilities Poor communication policy Absence of internal notification of little anomalies … Maybe we can not change people, but we most certainly can change the conditions under which humans work Incidents reported: Conclusions

The FANC reporting system is not intended to punish people (no blame, no shame) It is intended to give assistance and guidance It is part of an optimization, prevention and feedback approach: Incentive to improve patient safety Thorough analysis (all concerned parties) of the event and useful feedback to the sector (on an anonymous basis) Prevention of similar events reoccurring in other RT- departments Incidents reported: Conclusions