Information and Instructions for Registering with
NUCLEUS
Prior to registering with Safety Reporting and Learning System for Radiotherapy (SAFRON), the
registrant must register with NUCLEUS, the Agency’s information resource catalogue. The link
to NUCLEUS is: http://nucleus.iaea.org/Home/index.html
Instructions for Registering with SAFRON
SAFRON is an integrated voluntary reporting registry of radiation oncology incidents
and near misses. Its success is dependent on facilities registering and sharing incidents
that occur in their institutions. The registration form includes details on the equipment,
staff and environment in your centre. This information indicates the complexity of the
processes within departments. It will be used to carry out trend analyses of incidents in
relation to complexity of practice, working environment and educational background of
professional staff in a range of clinic types. The information will not be seen by other
users of SAFRON.
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Select the menu item “Request Registration.
Provide the name and address of hospital/clinic.
Provide the name, address, organizational role and email address for local
contact. Each hospital/clinic should provide details for ONE local contact.
The next question refers to the reporting requirements. Does your facility
have a reporting requirement when incidents happen? Are you required to
report incidents to a regulatory body? This may be a city, state, provincial, or
national requirement.
The succeeding questions concern the demographics of your facility. How
many machines are there in your facility, how many new patients are treated
annually, and what type of data networking is in place? Do you have a
recording and verification system in place? What is the staffing pattern for the
facility?
The next question asks whether equipment maintenance service is “in-house”
or contracted outside the facility.
The last question concerns the current status of quality assurance procedures
in the facility.
After providing the requested information, click on the “Submit” button.
You will receive notification by email that your application has been received
at the IAEA. IAEA staff will also be notified and will review your application.
Unless there is reason to believe that the submitted information is not
acceptable, the SAFRON team will approve your application and notify you
accordingly.
When you log on to SAFRON, you will see that “Submit Registration” has
changed to “View My Registration.” Please review your registration
periodically to ensure that the information is correct; it is possible to “Edit”
your registration.
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Thank you for registering with SAFRON.
Instructions for Submitting an Incident Report
Once you have registered your facility, you can go directly to “Submit Incident Report”.
On this screen, you will see a list of questions to help identify the nature of the incident
and where in the process of providing radiation therapy the incident was discovered.
1. The current version of SAFRON is for External Beam Radiotherapy. The scope
will be expanded in future to include brachytherapy and other treatment
modalities.
2. The date of discovery is needed for sorting data.
3. Complete the section on who discovered the incident and how it was discovered,
by selecting the appropriate item from the drop-down menus.
4. The next question asks what phase in the process the incident is associated with.
The list of process steps in radiation therapy is provided and, in the “Help Menu”,
you will find some examples of activities in the associated process. If you are
unsure of which process step to select, click on “Other” from the phase or process
step that most closely describes the situation. This will open a field in which you
can enter appropriate text. Alternatively, you can get in touch with the SAFRON
administrator at [email protected] for assistance.
5. The question what is the phase in the process is the incident associated with is
the actual location of the error or near miss while the question in item 4 above
refers to the phase the incident was discovered.
6. SAFRON would like to collect near misses as well as incidents. The next question
“Was anyone affected by the incident?” attempts to capture this information.
7. SAFRON would also like to collect details about the prescribed and administered
treatment, and the impact of any deviations. The prescribed dose information
should be in the numerical format of #.## for each fraction.
8. Clinical incident severity is a means for briefly conveying what potential harm an
incident may cause.
9. Summarize the incident in a single phrase. Do not include patient or facility
identification. The words in this field can serve as keywords for search purposes.
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You will also notice when you search incident event records that this phrase will
appear as the incident title text.
10. If the incident is related to equipment, please provide the details regarding make,
model and version number.
11. Please describe the event in more detail (than in the previous field).
12. The drop-down menu lists the possible causes of an incident, according to your
own analysis. It is possible to mark more than one cause.
13. Factors that contributed to the cause of an incident may become apparent only
after some evaluation. Equipment failure and faulty training may be obvious
contributing factors, but work environment and other stress factors may also play
a role in triggering an incident.
14. Provide information on the actions that were taken to address the exceptional
situation, especially with regard to ensuring patient safety and delivering the
prescribed treatment.
15. Describe the changes that were undertaken in your facility to prevent future
occurrences of this incident. The changes could involve requiring additional
training, implementing new standard operating procedures, preparing new
checklists and/or other methods to minimize the possibility for errors.
16. The question “Who should be or has been informed about the incident (e.g.
patient, responsible physician, hospital management, regulatory authority)” and
“Suggest preventive actions” are only seen and used by the reporting facility and
is not part of the data set seen by other reviewers?. These questions are for the
benefit of the reporting facility and may trigger additional action required by the
facility.
17. After submitting an incident to SAFRON, it is suggested to verify the details by
viewing the report en toto. Under “Action” in the Home Page, click on the “Search
for Incident Reports”, then toggle the dataset to “Own Incident Reports” (upper
right hand corner of the page).
Instructions for Using the Information in SAFRON
Search for Incidents
SAFRON’s purpose is to share information to educate others and prevent future
incidents. The identification feature allows users to search reported incidents and near
misses.
It may be useful for a facility to review incidents before beginning a new procedure or
purchasing new equipment. The information could enhance the quality assurance
program within the facility and provide information on the need for testing, training,
verification and development of procedures. For example in more than one reported
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case the lack of independent verification of machine output has resulted in medical
errors that have had significant impact on patient care.
To use this feature click on “Search for Incident Reports” then using the fields provided
search for information under the “What phase in the process is the incident associated
with?”;, “Who discovered the incident?”; “How was the incident discovered?, “Any word
in the free text fields.”
You can select any individual topic or select topics of interest such as “Commissioning”
process discovered by medical physicists. The free text field will search the text boxes
for the selected words and provide reports that include this word(s), such as linear
accelerator if you are interested in only those incidents. If you wish to review all
submitted reports then leave all fields blank and click on “Search”.
Search for Documents and Links
Reports serve a valuable purpose for identifying events, but published documentation
can assist the reviewer in understanding the complexity of incidents and identifying
methodologies that may have been used prevent future errors. Included in the listing
are published medical event reports, peer reviewed journal activity and presentation by
leading authorities with interest in preventing radiotherapy incidents. To review the
reports or links to additional information selects the tab entitled “Documents and Links”
and search either the “Process step” and/or “Any word in document/link title.”
Contributors are encouraged to add to the list relevant documents and links.
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