IAEA E-learning Program Safety and Quality in Radiotherapy

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.

Safety and Quality in Radiotherapy MODULE 7: root cause analysis 2: safety barriers & Preventive actions safron’s safety barriers & last few boxes 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. To very briefly mention learning and follow-up. Here is what we will do in this section.

Safety and Quality in Radiotherapy MODULE 7: root cause analysis 2: safety barriers & Preventive actions safron’s safety barriers & last few boxes SAFRON’s Safety Barriers This is the safety barrier table that we’ll fill in. We’ll see this again later.

Safety and Quality in Radiotherapy MODULE 7: root cause analysis 2: safety barriers & Preventive actions safron’s safety barriers & last few boxes SAFRON’s last few boxes We’ll make a few brief comments on the top 3 boxes but focus on Preventive Actions in this Module.

Safety and Quality in Radiotherapy MODULE 7: root cause analysis 2: safety barriers & Preventive actions safron’s safety barriers & last few boxes SAFRON’s last few boxes We have covered these in our root cause analysis. When actually reporting an incident it would be helpful to expand on them in our own words here. This is left as an exercise for the interested viewer. In module 6 we had a fairly extensive discussion of basic causes and contributing factors.

Safety and Quality in Radiotherapy MODULE 7: root cause analysis 2: safety barriers & Preventive actions safron’s safety barriers & last few boxes SAFRON’s last few boxes We have covered these in our root cause analysis. When actually reporting an incident it would be helpful to expand on them in our own words here. We don’t have enough information on these incidents to complete this box. We don’t have enough information on these incidents to complete this box.

Safety and Quality in Radiotherapy MODULE 7: root cause analysis 2: safety barriers & Preventive actions safron’s safety barriers & last few boxes SAFRON’s last few boxes We have covered these in our root cause analysis. When actually reporting an incident it would be helpful to expand on them in our own words here. We don’t have enough information on these incidents to complete this box. Neither do we have complete information on this issue. Neither do we have complete information on this issue.

Safety and Quality in Radiotherapy MODULE 7: root cause analysis 2: safety barriers & Preventive actions safron’s safety barriers & last few boxes SAFRON’s last few boxes We have covered these in our root cause analysis. When actually reporting an incident it would be helpful to expand on them in our own words here. We don’t have enough information on these incidents to complete this box. This will be our focus. On the following slides we will suggest Preventive Actions based on the Causes we identified in Module 6. Neither do we have complete information on this issue. This will be our focus. On the following slides we will suggest preventive actions based on the causes we identified in module 6.

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 Our first study will be on the New York State Incident.

Safety and Quality in Radiotherapy MODULE 7: root cause analysis 2: safety barriers & Preventive actions Section 1: The new york Incident March 2005, somewhere in the state of New York, USA A patient is due to be treated with IMRT for head and neck cancer (oropharynx). A reminder of the incident we are investigating. If you can remember the details you may want to skip this and the next slide. Hit the pause button if you want to stay longer on these slides. IAEA Prevention of accidental exposure in radiotherapy

Safety and Quality in Radiotherapy MODULE 7: root cause analysis 2: safety barriers & Preventive actions Section 1: The new york Incident SUMMARY Oropharynx patient was planned with IMRT. 1st four fractions were delivered correctly. Physician changed volume to avoid teeth. Original plan was copied and modified appropriately. During the “Save” operation, the computer crashed. The fluence distribution, but not the complete DRR and no MLC control points were saved. The absence of the MLC icon and confirmation of MLC activation were not noticed at the treatment console. QA of the modified plan was not performed until three fractions had been delivered. And here is the summary of the incident. The patient received 13 Gy per fraction for three fractions, i.e. 39 Gy in 3 fractions.

Safety and Quality in Radiotherapy MODULE 7: root cause analysis 2: safety barriers & Preventive actions Section 1: The new york 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. To very briefly mention learning and follow-up. First, we will look at safety barriers.

Safety and Quality in Radiotherapy MODULE 7: root cause analysis 2: safety barriers & Preventive actions Section 1: The new york Incident What is a safety barrier? A safety barrier is a step in the process designed to intercept errors that may have entered during previous steps. Safety barriers complement preventive actions developed through an incident learning system and process improvements implemented as a result of a failure modes and effects analysis. Another reminder from Module 4 of what a safety barrier is and its purpose. A common preventive action is to introduce more safety barriers such as check lists.

Safety and Quality in Radiotherapy MODULE 7: root cause analysis 2: safety barriers & Preventive actions Section 1: The new york Incident What’s the purpose of a safety barrier? Safety barriers are another way of enhancing the safety of a clinical process. However safe we design the process to be, there will always be the possibility of an error slipping through. Optimizing safety requires intrinsically safe procedures to start with together with safety barriers to catch the inevitable errors which will occur along the treatment preparation/delivery pathway. Safety barriers are another way of enhancing the safety of a clinical process. However safe we design the process to be, there will always be the possibility of an error slipping through.

Safety and Quality in Radiotherapy MODULE 7: root cause analysis 2: safety barriers & Preventive actions Section 1: The new york Incident SAFRON’s Safety Barriers Coming back to the New York State incident, again, we don’t have all the details to fill this in accurately so some of the entries are guesswork. At least one of the entries in the right most column, in vivo dosimetry, would almost certainly have found the error.

Safety and Quality in Radiotherapy MODULE 7: root cause analysis 2: safety barriers & Preventive actions Section 1: The new york 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. To very briefly mention learning and follow-up. Now we’ll look at preventive measures.

Safety and Quality in Radiotherapy MODULE 7: root cause analysis 2: safety barriers & Preventive actions Section 1: The new york Incident Preventive Actions? Preventive actions are implemented as a result of an incident investigation with the purpose of minimizing the probability and severity of a similar incident occurring in the future. Preventive actions can be derived from the causal analysis. In the following slides, we’ll recall our basic causes from Module 6 and suggest preventive actions.

Safety and Quality in Radiotherapy MODULE 7: root cause analysis 2: safety barriers & Preventive actions Section 1: The new york Incident Preventive Actions? As we’ve noted previously, we don’t have all the details of the incidents which we are using in the examples throughout this e-learning program. We don’t know exactly what happened after the incident in terms of preventive actions implemented. We will make reasonable judgments as we continue to work through the SAFRON form. As we’ve noted previously, we don’t have all the details of the incidents which we are using in the examples throughout this e-learning program. In particular we don’t know exactly what happened after the incident in terms of Preventive Actions implemented. We will make reasonable judgments as we continue to work through the SAFRON form.

Safety and Quality in Radiotherapy MODULE 7: root cause analysis 2: safety barriers & Preventive actions Section 1: The new york Incident Basic Causes These are the basic causes we identified in module 6 for this incident. We need to select and implement one or more preventive actions for each of these basic causes . Here are the Basic Causes we identified in Module 6 for this incident. We will go through them one by one. Policy not followed = 1.3 Standard/Procedure/Practice not followed. TPS system Fault = 2.2 Defective equipment. Risk awareness = 3.2 Inadequate design specification. Workload pressures = 4.6 Personnel availability. Lack of training = 6.1 Inadequate training/orientation.

Safety and Quality in Radiotherapy MODULE 7: root cause analysis 2: safety barriers & Preventive actions Section 1: The new york Incident Preventive Actions There are at least two ways in which standard operating procedures (assuming they existed) were not followed. Patient specific quality control was not performed prior to the first treatment with the revised plan. Both therapists, out of concern for the patient, did not pay adequate attention to the treatment machine monitor. Actions which could help prevent a similar incident in the future include: Continuous reinforcement to staff of the importance of following standard operating procedures to the letter – no exceptions. A time-out before beam on to carefully review all the critical details of the treatment. Reviewing (or writing) the relevant Standard Operating Procedure to ensure clarity. There are at least two ways in which standard operating procedures, assuming they existed, were not followed. 1) Patient specific quality control was not performed prior to the first treatment with the revised plan. 2) Both therapists, out of concern for the patient, did not pay adequate attention to the treatment machine monitor. Actions which could help prevent a similar incident in the future include: 1) Continuous reinforcement to staff of the importance of following standard operating procedures to the letter – no exceptions. 2) A Time-Out before Beam On to carefully review all the critical details of the treatment. 3) Reviewing or writing the relevant Standard Operating Procedure to ensure clarity.

Safety and Quality in Radiotherapy MODULE 7: root cause analysis 2: safety barriers & Preventive actions Section 1: The new york Incident Preventive Actions The treatment planning computer crashed several times during the preparation of this revised treatment plan. As this is an equipment design issue it can only be properly addressed by the manufacturer. This is actually what happened as a consequence of this incident. The treatment planning computer crashed several times during the preparation of this revised treatment plan. As this is an equipment design issue it can only be properly addressed by the manufacturer. This is actually what happened as a consequence of this incident.

Safety and Quality in Radiotherapy MODULE 7: root cause analysis 2: safety barriers & Preventive actions Section 1: The new york Incident Preventive Actions In our assignment of basic causes we used “inadequate design specification” to indicate a lack of risk awareness. “Inadequate design specification” from the SAFRON basic causes taxonomy refers to the design of the clinical process and not the equipment. Risk awareness is a central feature of a well developed safety culture. By implementing and actively and continually engaging staff in tools such as incident learning systems and failure modes and effects analysis a higher level of risk awareness will be developed. There is no one simple measure that, on its own, can fully address the issue of risk awareness. In our assignment of basic causes we used ‘inadequate design specification’ to indicate a lack of risk awareness. “Inadequate design specification” from the SAFRON Basic Causes taxonomy refers to the design of the clinical process and not the equipment. Risk awareness is a central feature of a well-developed safety culture as discussed in Module 11. By implementing and actively and continually engaging staff in tools such as incident learning systems and failure modes and effects analysis a higher level of risk awareness will be developed. There is no one simple measure that, on its own, can fully address the issue of risk awareness.

Safety and Quality in Radiotherapy MODULE 7: root cause analysis 2: safety barriers & Preventive actions Section 1: The new york Incident Preventive Actions The revised plan was done in a considerable rush for reasons that are not entirely clear. It’s a matter of common experience that errors occur more frequently under such conditions. Actions that could help prevent such an incident from happening again include: Hiring more staff. However, most institutions are reluctant to do this. Establishing a minimum amount of time for the generation and validation of all plans but particularly complex plans. Establishing an agreed upon method for prioritizing activities so that safety critical activities take precedence over others when the staff is working under pressure. The revised plan was done in a considerable rush for reasons that are not entirely clear. It’s a matter of common experience that errors occur more frequently under such conditions. Actions that could help prevent such an incident from happening again include: 1) Hiring more staff. However, most institutions are reluctant to do this. 2) Establishing a minimum amount of time for the generation and validation of all plans but particularly complex plans. 3) Establishing an agreed upon method for prioritizing activities so that safety critical activities take precedence over others when the staff is working under pressure.

Safety and Quality in Radiotherapy MODULE 7: root cause analysis 2: safety barriers & Preventive actions Section 1: The new york Incident Preventive Actions This issue is related to Basic Causes 1.3 and 3.2. Actions that could effective as a response to this Basic Cause include: A well designed check list that requires confirmation of the correct positions of the multileaf collimator leaves. Independent review of clinical processes, including at the machine, by an experienced staff member. Department wide discussion of incidents, including near misses, which have happened in the clinic. An Incident Learning System clearly facilitates this action. Safety Rounds at which events and activities reported in the literature are reviewed. Actions that could be effective as a response to this Basic Cause include: 1) A well designed check list that requires confirmation of the correct positions of the multileaf collimator leaves. 2) Independent review of clinical processes, including at the machine, by an experienced staff member. 3) Department wide discussion of incidents, including near misses, which have happened in the clinic. An Incident Learning System clearly facilitates this action. 4) Safety Rounds at which events and activities reported in the literature are reviewed.

Safety and Quality in Radiotherapy MODULE 7: root cause analysis 2: safety barriers & Preventive actions Section 1: The new york 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. To very briefly mention learning and follow-up. Now learning and follow-up will be briefly mentioned.

Safety and Quality in Radiotherapy MODULE 7: root cause analysis 2: safety barriers & Preventive actions Section 1: The new york Incident Learning While those involved with the incident and those carrying out the investigation will undoubtedly have learned from the experience, safety across the clinic and beyond will be enhanced if the lessons learned are shared. Internal learning will be enhanced by the following: Brief email blasts highlighting a recent incident, actual or potential. Providing regular updates to staff on safety issues through departmental meetings. External learning will be accomplished by actively participating in a national or international incident learning system, many of which we discussed in module 3. While those involved with the incident and those carrying out the investigation will undoubtedly have learned from the experience, safety across the clinic and beyond will be enhanced if the lessons learned are shared. Internal learning will be enhanced by the following: brief email blasts highlighting a recent incident, actual or potential. Or providing regular updates to the staffs on safety issues through departmental meetings. External learning will be accomplished by actively participating in a national or international incident learning system many of which we discussed in module 3.

Safety and Quality in Radiotherapy MODULE 7: root cause analysis 2: safety barriers & Preventive actions Section 1: The new york Incident Follow-up A lot of effort can be put into root cause analysis. It is important, then, that some system improvement results. Once preventive actions have been selected, the following steps should be followed: Assign one or more preventive actions to individual members of staff. Ensure sufficient personnel and capital resources are available for the completion of the task. Agree on a timelines for completion and milestones along the way. Ensure that documentation, however brief, is maintained throughout the task. Monitor progress by comparing with the established timelines. When the preventive actions has been implemented and the task is considered complete, monitor to ensure that the Preventive Action is as effective as expected. A lot of effort can be put into root cause analysis. It is important, then, that some system improvement results. Once preventive actions have been selected, the following steps should be followed: assign one or more preventive actions to individual member of staffs. Assigning this specific task to committees or groups of people can result in confusion. If the group has to be involved, then there should be one identified leader. Ensure sufficient personnel and capital resources are available for the completion of the task. Agree on a timelines for completion and milestones along the way. Ensure that documentation, however brief, is maintained throughout the task. Monitor progress by comparing with the established timelines. When the Preventive Action has been implemented and the task is considered complete, monitor to ensure that the preventive action is as effective as expected.

Safety and Quality in Radiotherapy MODULE 7: root cause analysis 2: safety barriers & Preventive actions Section 1: The new york 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. Here is the summary. 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.