1. IAEA E-learning Program
Safety and Quality in Radiotherapy

2. Safety and Quality in Radiotherapy
MODULE 7: root cause analysis 2: safety barriers & Preventive actions
Sections:
7.1 The New York State Incident
7.2 The Epinal Incident
7.3 The Toulouse Incident
In this module we will complete the data entry into SAFRON for safety barriers and preventive actions. As before, the examples are based on the three incidents we have discussed throughout this e-learning program.

3. Safety and Quality in Radiotherapy
MODULE 7: root cause analysis 2: safety barriers & Preventive actions
Sections:
7.1 The New York State Incident
7.2 The Epinal Incident
7.3 The Toulouse Incident
We will now repeat the exercise for the Epinal incident.

4. Safety and Quality in Radiotherapy
MODULE 7: root cause analysis 2: safety barriers & Preventive actions
Section 2: The epinal incident
OBJECTIVES
To suggest which Safety Barriers the incident might have penetrated and any that might have been effective in this situation.
To consider what Preventive Actions could be implemented as a result of the investigation of this incident.
Our objectives are as before.

5. Safety and Quality in Radiotherapy
MODULE 7: root cause analysis 2: safety barriers & Preventive actions
Section 2: The epinal incident
In May 2004 at Centre Hospitalier Jean Monnet in Epinal, France
It was decided to change from static (hard) wedges to dynamic (soft) wedges for prostate cancer patients.
In a country of few Medical Physicists (MP), this facility had a single MP who was also on call in another clinic.
If you can remember the details this and the next slide can be skipped. Again, hit the pause button if you want to stay longer on these pages.
The Jean Monnet in Epinal
IAEA Prevention of accidental exposure in radiotherapy

6. Safety and Quality in Radiotherapy
MODULE 7: root cause analysis 2: safety barriers & Preventive actions
Section 2: The epinal incident
summary
The clinic decided to implement the use of dynamic (soft) wedges.
Treatment planners were given very limited training on planning with dynamic wedges.
The treatment planning system manual was in a non-native language.
The only medical physicist on staff was also on call for another clinic.
Monitor units were calculated for plans developed using (mistakenly) hard (physical) wedges.
Treatments were delivered with dynamic wedges.
As the monitor units for a hard wedged beam are typically considerably higher than those for a dynamically wedged beam for the same dose, the patients involved received excessive doses.
And here is the summary of the incident.
At least 23 patients received an overdose (20% or more than the intended dose).

7. Safety and Quality in Radiotherapy
MODULE 7: root cause analysis 2: safety barriers & Preventive actions
Section 2: The epinal incident
OBJECTIVES
To suggest which Safety Barriers the incident might have penetrated and any that might have been effective in this situation.
To consider what Preventive Actions could be implemented as a result of the investigation of this incident.
First, we will look at safety barriers.

8. Safety and Quality in Radiotherapy
MODULE 7: root cause analysis 2: safety barriers & Preventive actions
Section 2: The epinal incident
SAFRON’s Safety Barriers
Again, we don’t have all the details to fill this in accurately so some of the entries are guesswork. Looking at the right most column, it is apparent that the potential effectiveness of the various safety barriers for an incident of this type is quite variable. For example, in vivo dosimetry would almost certainly have picked up this error, whereas it might be missed on a time-out.

9. Safety and Quality in Radiotherapy
MODULE 7: root cause analysis 2: safety barriers & Preventive actions
Section 2: The epinal incident
OBJECTIVES
To suggest which Safety Barriers the incident might have penetrated and any that might have been effective in this situation.
To consider what Preventive Actions could be implemented as a result of the investigation of this incident.
And now preventive actions.

10. Safety and Quality in Radiotherapy
MODULE 7: root cause analysis 2: safety barriers & Preventive actions
Section 2: The epinal incident
Basic Causes
These are the Basic Causes we assigned to this incident in Section 6.4. We need to select and implement one or more Preventive Actions for each of these Basic Causes.
These are the Basic Causes we assigned to this incident in Section 6.4. We need to select and implement one or more Preventive Actions for each of these Basic Causes.
Documentation = 4.5 Inadequate documentation.
Training = 6.1 Inadequate training/orientation.
Risk awareness = 3.1 Inadequate hazard assessment.
Lack of protocol = 1.1 Not developed.
Staffing shortages = 4.6 Personnel availability.

11. Safety and Quality in Radiotherapy
MODULE 7: root cause analysis 2: safety barriers & Preventive actions
Section 2: The epinal incident
Preventive Actions
There appeared to be no standard operating procedures written for planning and treating with a dynamic or soft wedge. The Preventive Action in this case is, of course, to develop such a document. The originator of the document should have a solid grasp of the science and technology involved in dynamic wedge treatments. However, before final approval for use in the clinic, review by the users of the document is essential. The users need to confirm that the procedure as written down is clear, complete and unambiguous. Having the document reviewed by an experienced user of dynamic wedges in another clinic would add another layer of safety.
There appeared to be no standard operating procedures written for planning and treating with a dynamic (soft) wedge.
The preventive action in this case is, of course, to develop such a document. The originator of the document should have a solid grasp of the science and technology involved in dynamic wedge treatments. However, before final approval for use in the clinic, review by the users of the document is essential. The users need to confirm that the procedure as written down is clear, complete and unambiguous.
Having the document reviewed by an experienced user of dynamic wedges in another clinic would add another layer of safety.

12. Safety and Quality in Radiotherapy
MODULE 7: root cause analysis 2: safety barriers & Preventive actions
Section 2: The epinal incident
Preventive Actions
The possibility of confusion between a hard wedge and a dynamic wedge doesn’t appear to have been considered. The most appropriate Preventive Action in a situation where new equipment or processes are being introduced is to perform prospective risk management. Techniques such as Failure Modes and Effects Analysis and Fault Tree Analysis are described later in this e-learning program.
The possibility of confusion between a hard wedge and a dynamic wedge doesn’t appear to have been considered.
The most appropriate preventive action in a situation where new equipment or processes are being introduced is to perform prospective risk management. Techniques such as failure modes and effects analysis and fault tree analysis are described later in this e-learning program.

13. Safety and Quality in Radiotherapy
MODULE 7: root cause analysis 2: safety barriers & Preventive actions
Section 2: The epinal incident
Preventive Actions
A central issue in this incident was that the instructions for the use of the treatment planning computer were in a language that the staff could not fully understand. Actions to prevent such a cause arising again in the future include a guarantee from the equipment supplier, at the time of signing the purchase order that all instructions and documentation shall be provided in a specified language.
A central issue in this incident was that the instructions for the use of the treatment planning computer were in a language that the staff could not fully understand.
Actions to prevent such a cause arising again in the future include a guarantee from the equipment supplier, at the time of signing the purchase order, that all instructions and documentation shall be provided in a specified language(s).

14. Safety and Quality in Radiotherapy
MODULE 7: root cause analysis 2: safety barriers & Preventive actions
Section 2: The epinal incident
Preventive Actions
At the time of this incident, there was chronic understaffing of medical physics in France.
One response to this incident, and others that took place in France was to dramatically increase the training capacity for Medical Physicists in the country.
At the time of this incident there was chronic understaffing of medical physicists in France.
One response to this incident, and others that took place in France, was to dramatically increase the training capacity for medical physicists in the country.

15. Safety and Quality in Radiotherapy
MODULE 7: root cause analysis 2: safety barriers & Preventive actions
Section 2: The epinal incident
Preventive Actions
The level of training of the Medical Physicist in the use of dynamic wedges is unclear. What is clear, however, is that the therapy staff had not received adequate training. Preventive Actions would include: 1) Having a representative of the equipment manufacturer provide on-site training and be present for the first few clinical treatments with the new process. 2) Identifying a few “super-users” of the equipment. Super-users would receive advanced training from the equipment supplier and then supervise the equipment’s use and act a resource to clinic staff.
The level of training of the Medical Physicist in the use of dynamic wedges is unclear. What is clear, however, is that the therapy staff had not received adequate training.
Preventive Actions would include:
Having a representative of the equipment manufacturer provide on-site training and be present for the first few clinical treatments with the new process.
Identifying a few “super-users” of the equipment. Super-users would receive advanced training from the equipment supplier and then supervise the equipment’s use and be a resource to clinic staff.

16. Safety and Quality in Radiotherapy
MODULE 7: root cause analysis 2: safety barriers & Preventive actions
Section 2: The epinal incident
summary
We have:
Suggested which Safety Barriers the incident might have penetrated and any that might have been effective in this situation.
Considered what Preventive Actions could be implemented as a result of the investigation of this incident.
This is the summary of what we did. We have suggested which safety barriers the incident might have penetrated and any that might have been effective in this situation. And we have considered what preventive actions could be implemented as a result of the investigation of this incident.