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Patient Care and Research

RO-ILS My Review Data Elements

The “My Review” page is where designated internal Reviewers can enter follow-up analysis and eventually report the event to the PSO. This section includes more detailed questions, some of which may require investigation into the event. Extensive branching logic reduces the total number of questions that may appear for a given event. The data elements are listed in the order in which they appear in the RO-ILS portal. An asterisk symbol (*) indicates a required question.

Download a printable PDF of all RO-ILS data elements.


201. Event_Title

Question: Event Title: (200 character limit):
Response Option: Free Text
Branching Logic: None

233. Problem_Type

Question: *Problem Type:

Note: This data element has been adapted with permission from the National System for Incident Reporting - Radiation Treatment Minimum Data Set (Ottawa, Ont.: CIHI, 2022).

Response Option:
  • Laterality incorrect
  • Anatomical site (excluding laterality) incorrect
  • Patient incorrect
  • Patient position, setup point, treatment isocenter, or shift change incorrect 
  • Treatment accessories: incorrect, missing, mislabeled, misused or damaged
  • Prescription, dose, fractionation incorrect or not matching physician intent 
  • Dose calculation error
  • Target or OAR contours incorrect or omitted
  • Planning margins incorrect
  • Treatment plan isodose distribution unacceptable
  • Treatment undeliverable: plan (dosimetrically acceptable) but not physically deliverable
  • Treatment undeliverable: staff unavailable (excluding patient factors)
  • Treatment undeliverable: hardware/software unavailable
  • Hardware/software malfunction or product improvement/enhancement
  • Imaging: excess, inadequate, not matching physician intent  
  • Access to timely care issue (insurance, transportation etc.) 
  • Decision-making suboptimal or made on clinical information which is insufficient or incorrect
  • Coordination with other health care providers inadequate
  • Delay/issue in workflow or error in RT scheduling 
  • Fall, patient injury, or acute medical event
  • Other
    • *Specify 'Other' Problem Type:
Branching Logic: None

202. Discoverer_Role

Question: Role of person who discovered the event: (Select all that apply)
Response Option:
  • Administrator
  • Dosimetrist
  • Nurse, NP or PA
  • Patient or Patient Representative
  • Physician
  • Physicist
  • Radiation Therapist
  • Other
    • *Specify 'Other' Discoverers' Role:
Branching Logic: None

203. Patient_Age

Question: Patient's Age:
Response Option:
  • 0-28 days
  • 29 days to less than 1 year
  • 1-12 years
  • 13-17 years
  • 18-64 years
  • 65-74 years
  • 75-84 years
  • 85+ years
  • Unknown
  • Report not patient related
Branching Logic: None

204. Patient_Gender

Question: Patient's Gender:
Response Option:
  • Female
  • Male
  • Unknown
  • Report not patient related
Branching Logic: None

205. Narrative_Supplemental

Question: Supplemental Information/Additional Follow-up to Event Narrative:
Response Option: Free Text
Branching Logic: None

206. Discovered_Description

Question: How was the event discovered?
Response Option: Free Text
Branching Logic: None

207. Discovered_Workflow

Question: *In what workflow step was the event first discovered?
Response Option:
  • Before Simulation
  • Pre-planning Imaging and Simulation
  • Treatment Planning
  • Pre-Treatment QA Review (e.g., Physics Plan Check)
  • Treatment Delivery including imaging (e.g., at the machine)
  • On-Treatment QA (e.g., weekly check, physician OTV)
  • After Treatment Course is Finished
  • Equipment and Software QA
  • Outside the Radiation Therapy Workflow or Other
    • *Specify 'Other' Workflow Step of Discovery:
Branching Logic: None

208. Occured_Workflow

Question: *In what workflow step(s) did the event occur? (Select all that apply)
Response Option:
  • Before Simulation
  • Pre-planning Imaging and Simulation
  • Treatment Planning
  • Pre-Treatment QA Review (e.g., Physics Plan Check
  • Treatment Delivery Including Imaging (e.g., at the machine)
  • On-Treatment QA (e.g., weekly check, physician OTV)
  • After Treatment Course is Finished
  • Equipment and Software QA
  • Outside the Radiation Therapy Workflow or Other
    • *Specify 'Other' Workflow Step of Occurrence:
Branching Logic: None

209. Imaging

Question: Treatment imaging being used: (Select all that apply)
Response Option:
  • kV or MV radiographs
  • kV or MV Cone-beam CT
  • Ultrasound
  • Electromagnetic Transponders
  • Optical (surface) imaging
  • MRI
  • None
  • Not Applicable
  • Other
    • *Specify 'Other' Imaging:
Branching Logic: If “Therapeutic Radiation Incident” selected for #104

210. Systematic_Error

Question: *Was this a systematic error that affected multiple patients?
Response Option:
  • Yes
  • No
Branching Logic: If “Therapeutic Radiation Incident” OR “Other Safety Incident” selected for #104

211. Systematic_Patient_Number

Question: How many patients were affected by the error?
Response Option: Free Text
Branching Logic: If “Yes” selected for #210

212. Dose_Devitation

Question: *What was the dose deviation for the course of treatment between the planned total prescription and the delivered dose? (Select all that apply)
Response Option:
  • ≤5% maximum dose deviation to target
  • >5% but ≤25% maximum dose deviation to target
  • >25% but ≤100% maximum dose deviation to target
  • >100% maximum dose deviation to target
  • OAR(s) received more than intended but within tolerance levels
  • OAR(s) received more than intended and exceeded tolerance levels
  • Not Applicable
Branching Logic: If “No” selected for #210

213. Fractions_Incorrect

Question: How many fraction(s)/treatment(s) were delivered incorrectly?
Response Option: Free Text
Branching Logic: If response options 1-6 selected for #212

214. Fractions_Total

Question: How many total fractions were prescribed for the course of treatment?
Response Option: Free Text
Branching Logic: If response options 1-6 selected for #212

232. Dosimetric_Change

Question: *Was a dosimetric change to the plan (e.g., replanning) made as a result of the event?
Response Option:
  • Yes
  • No
Branching Logic: None

215. Equipment_Related

Question: *Was this event equipment related?
Response Option:
  • Yes
  • No
Branching Logic: None

216. Equipment_Simulator

Question: Simulator (Manufacturer: Type) related to this event, if applicable:
Response Option: A standardized list is provided - practices can choose to display a subset of the list
Branching Logic: If “Yes” selected for #215

217. Equipment_Planning

Question: Treatment Planning Systems (Manufacturer: Model) related to this event, if applicable:
Response Option: A standardized list is provided - practices can choose to display a subset of the list
Branching Logic: If “Yes” selected for #215

218. Equipment_OIS

Question: Treatment Management System: OIS (Manufacturer: Model) related to this event, if applicable:
Response Option: A standardized list is provided - practices can choose to display a subset of the list
Branching Logic: If “Yes” selected for #215

234. Equipment_EHR

Question: Treatment Management System: EHR (Manufacturer: Model) related to this event, if applicable:
Response Option: A standardized list is provided - practices can choose to display a subset of the list
Branching Logic: If “Yes” selected for #215

219. Equipment_External_Photon

Question: Treatment Delivery Equipment: External Beam Photon/Electron (Manufacturer: Model) related to this event, if applicable:
Response Option: A standardized list is provided - practices can choose to display a subset of the list
Branching Logic: If “Yes” selected for #215

220. Equipment_External_Particles

Question: Treatment Delivery Equipment: Particles (Manufacturer: Model) related to this event, if applicable:
Response Option: A standardized list is provided - practices can choose to display a subset of the list
Branching Logic: If “Yes” selected for #215

235. Equipment_Brachy

Question: Treatment Delivery Equipment: Brachytherapy (Manufacturer: Type/Model) related to this event, if applicable:
Response Option: A standardized list is provided - practices can choose to display a subset of the list
Branching Logic: If “Yes” selected for #215

221. Equipment_Other

Question: Other Equipment: QA, Accessories, Devices (Manufacturer: Type/Model) related to this event, if applicable:
Response Option: A standardized list is provided - practices can choose to display a subset of the list
Branching Logic: If “Yes” selected for #215

236. Equipment_Details

Question: Please specify any additional information (e.g., version, secondary equipment) regarding the equipment involved in this event.
Response Option: Free text
Branching Logic: If “Yes” selected for #215

222. Reported_PSO

Question: *Do you want to report this event to the PSO?

Note: "Yes" is the default answer. Unless you affirmatively select "No", your event will be reported to the PSO. Once reported to the PSO, you cannot retract the information. Reports will be updated if/when additional data are added after submission to the PSO. All information remains in the RO-ILS portal.

Response Option:
  • Yes
  • No
Branching Logic: None

223. Reported_External

Question: *Have you reported, or do you anticipate reporting, this event outside of RO-ILS/PSES?

Note: If information about this event is needed outside of RO-ILS/PSES, HHS recommends that providers should maintain at least two separate systems, one for PSWP and one for maintaining records for external obligations.

Response Option:
  • Yes
  • No
  • Don't know
Branching Logic: None

224. Reported_External_Entities

Question: To whom was the event reported? (Select all that apply)
Response Option:
  • FDA
  • NRC
  • State
  • Vendor/Manufacturer
  • Other
    • *Specify 'Other' External Entity:
Branching Logic: If "Yes" selected for #223

225. Significance_Scale

Question: *In terms of risk to patient safety, how significant was this event?
Response Option:
  • Mild
  • Moderate
  • Severe
Branching Logic: None

226. Prevention_Ideas

Question: What might prevent future events like this?
Response Option: Free Text
Branching Logic: None

227. Intervention

Question: What changes, if any, has the facility made in response to the event?
Response Option: Free Text
Branching Logic: None

228. Additional_Details

Question: Please provide any additional details in the space provided below:
Response Option: Free Text
Branching Logic: None

229. Internal_Use

Question: You may use this space for your internal use (i.e. internal tags):
Response Option: Free Text
Branching Logic: None

230. Status

Question: *Status:

Note: "Submitted" is the default answer. User should change event status to "Closed" when the event review and investigation has been completed. 

Response Option:
  • Submitted
  • Closed
Branching Logic: None

231. Contributing_Factors

Question: Contributing factors: (Select all that apply)
Response Option:
  1. Organizational Management
    1. Inadequate Resources
      • Inadequate human resources
      • Inadequate capital resources
    2. Policies, Procedures, Regulations
      • Relevant policy nonexistent
      • Policy inadequate
      • Policy not followed
      • Conflicting policies
      • External regulation (e.g., state/federal) not followed
    3. Training
      • Facility training inadequate
      • Vendor-provided training inadequate
      • Inadequate assessment of staff competencies
      • Lack of continuing education
    4. Leadership and Culture
      • Inadequate safety culture
      • Failure to remedy past known shortcomings
      • Hostile work environment
      • Inadequate supervision
      • Lack of peer review
      • Outdated practices
    5. Physical Environment
      • Physical environment inadequate
      • Distractions or Interruptions in the environment
  1. Communication
    • Poor, incomplete, unclear or missing
    • Lack of timeliness
    • Inadequate communication patterns designed
    • Failure to request needed information
    • Written documentation in EMR incorrect/incomplete/absent
    • Verbal instructions inconsistent with documentation
  1. Procedural issues
    1. Failure to detect a developing problem or appreciate its nature/importance
      • Environmental masking (e.g., noise or obscuring interference)
      • Distraction and loss of attention
      • Lack of information
      • Expectation Bias (e.g., expecting to observe a certain effect and therefore being biased toward seeing it)
    2. Failure to interpret the nature of the developing problem
      • Inadequate search
      • Missing information
      • Incorrect information
    3. Failure to develop an effective plan to combat the problem
      • Information not seen or sought
      • Information misinterpreted
      • Inappropriate assumptions
      • Unintended consequences
    4. Failure to execute the planned action
      • Plan started but not completed
      • Plan misinterpreted
      • Plan too complicated
    5. Inadequate quality assurance and quality control
  1. Technical
    1. Acceptance testing and commissioning
      • Not following or reviewing established best-practice (AAPM TG reports, ASTRO, ACR, IPEM, COMP, etc.)
      • Lack of independent review
      • Lack of effective documentation (vendor or self)
    2. Equipment design and operations
      • Inadequate policies and procedures for quality assurance and quality control
      • Poor human factors engineering
      • Interoperability problem
      • Networking (IT) or Software problems
      • Treatment machine downtime (non-software/IT)
      • Other equipment/hardware failure (non-software/IT)
    3. Equipment maintenance issues
      • Failure to report problems to vendor
      • Failure to follow vendor notices (field change orders)
      • Failure to provide adequate preventive maintenance
      • Failure on the vendor's part to share failure/safety issues in a timely manner
      • Unavailability of local and field support
    4. Environment (within the facility and external)
      • Ergonomics (room layout, equipment setup)
      • Machine collision issues (room specific)
      • Environment (water, HVAC, electrical, gas)
      • Natural environment/disasters and hazards
  1. Human behavior involving staff
    • Compressed time scale, rushing
    • Acting outside one's scope of practice
    • Slip causing physical error (failure in performance of highly developed skills as intended or maintained)
    • Intentional rules violations (sabotage/criminal acts, criminal intent, intentional violation)
    • Negligence (risky behavior, poor judgment in failure to address issues or extreme demands, lack of vigilance; recklessness)
    • Failure to follow through
  1. Patient-focused circumstances
  1. Other
    • *Please specify 'Other':

Branching Logic: None