July 2016 Tip of the Month
New Data Elements
Tip:
Prepare for the RO-ILS: Radiation Oncology Incident Learning System® data element update scheduled for late August by reviewing the revised questions and answers.
Background:
After a year of gathering user feedback and conducting an interrater reliability study, the new RO-ILS data elements will be live in the portal in late August. The revised data elements will simplify data collection and increase analysis utility for both participating practices and the Radiation Oncology Healthcare Advisory Council (RO-HAC). A full list of data elements is below.
Summary of Changes:
1. Removal of inconsistent and non-critical data elements, resulting in fewer overall questions.
In total, there are now forty possible questions. However, the number of questions for an individual incident is dependent on branching logic and all forty questions would only be applicable for the most critical of incidents.
2. Development of new sophisticated branching logic to display only relevant questions.
Branching logic helps reduce the total number of questions, especially for events that did not reach the patient. For example, if a user selects “Yes” for question #214: “Was this event equipment related?” they will be prompted to answer the six follow-up equipment questions.
3. Requiring that certain questions be answered by the user in order to facilitate thorough and complete analysis.
Required questions are indicated by a red asterisk*. On the “Submit Event: Live Event” page, there are five required questions with the possibility of two additional required questions depending on practice location information. On the “My Review: Follow-up” page, there are nine required questions with the possibility of three additional require questions depending on branching logic.
4. Additional clarification on answer options.
New answer options were added or existing responses revised to a number of questions to provide more details about safety events. For example, the current list of contributing factors (#230) was not specific enough to benefit analysis efforts, therefore answer options were modified and significantly refined to better reflect clinical practice. The new data elements will also now collect information regarding radiation dose delivered to organs at risk (OARs) in addition to the target (#212).
5. Practice-specific equipment information tied with user logins.
Clarity PSO collected your practices’ manufacturer and model information via a survey earlier this month so that you can take advantage of a new enhancement to the Healthcare SafetyZone® Portal which will associate equipment available at your practice with your log-in information. This enhancement was made in response to participants wishing to simplify data entry. If the RO-ILS PSO liaison missed the deadline, there will be another opportunity to provide this information to take advantage of this added benefit. Please note that this information will only be used within the portal, though aggregate data may be used for demographic information.
6. Contributing Factors information will now be located on a separate tab.
As previously mentioned, the list of contributing factors has expanded and will now appear separately from the “My Review: Follow-up” section. While this question is not required, it is critical information which will allow you and the RO-HAC to identify overall patterns and areas for improvement.
New Data Elements:
“Submit Event: Live Event” Page
101. Question: *Location:
Response Options: The response options are specific to each contract.
Branching Logic: None
102. Question: *Sub Location:
Response Options: The response options are specific to each contract.
Branching Logic: If applicable, based on contract.
103. Question: *Additional Location:
Response Options: The response options are specific to each contract
Branching Logic: If applicable, based on contract.
104. Question: *Event Classification:
Response Options:
- Therapeutic Radiation Incident: Radiation dose not delivered as intended, with or without harm
- Other Safety Incident: Event that reached the patient, not involving radiation dose, with or without harm (examples: collision, fall, etc.)
- Near-miss: A safety event that did not reach the patient
- Unsafe condition: Any condition that increases the probability of a safety event
- Operational/Process Improvement: non-safety event
Branching Logic: None
105. Question: *Narrative: (Briefly describe the event, 4000 character limit)
Response Options: Free Text
Branching Logic: None
106. Question: *Treatment technique pertinent to event: (Select all that apply)
Response Options:
- 2D
- 3D
- IMRT/VMAT
- SRS/SBRT
- Particles (Protons)
- Electrons
- Intraoperative
- kV x-rays (i.e. Orthovoltage and superficial)
- LDR
- List the radioisotope, model, temporary/permanent, and manufacturer
- HDR
- List the radioisotope and delivery unit manufacturer and model
- Radiopharmaceuticals
- List the radioisotope type and manufacturer
- Total body irradiation (TBI)
- Not Applicable
- Other (Please specify)
- *Please specify 'Other':
Branching Logic: None
107. Question: Local Identifier:
Response Options: Free Text
Branching Logic: None
108. Question: Reporter's Name:
Response Options: Free Text
Branching Logic: None
109. Question: *Date and time the event occurred:
Response Options: MM/DD/YYYY, XX:XX AM/PM
Branching Logic: None
“My Review: Follow-up” Page
201. Question: Event Title: (200 character limit):
Response Options: Free Text
Branching Logic: None
202. Question: Role of person who circleovered the event: (Select all that apply)
Response Option:
- Administrator
- Dosimetrist
- Nurse, NP or PA
- Patient or Patient Representative
- Physician
- Physicist
- Radiation Therapist
- Other
- *Please specify 'Other':
Branching Logic: None
203. Question: *Patient's Age:
Response Options:
- 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. Question: *Patient's Gender:
Response Options:
- Female
- Male
- Unknown
- Report not patient related
Branching Logic: None
205. Question: Supplemental Information/Additional Follow-up to Event Narrative:
Response Options: Free Text
Branching Logic: None
206. Question: *How was the event circleovered?
Response Options: Free Text
Branching Logic: None
207. Question: *In what workflow step was the event first circleovered?
Response Options:
- 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
- *Please specify ‘Other’:
Branching Logic: None
208. Question: *In what workflow step(s) did the event occur? (Select all that apply)
Response Options:
- 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
- *Please specify ‘Other’:
Branching Logic: None
209. Question: Treatment imaging being used: (Select all that apply)
Response Options:
- kV or MV radiographs
- kV or MV Cone-beam CT
- Ultrasound
- Electromagnetic Transponders
- Optical (surface) imaging
- MRI
- None
- Not Applicable
- Other
- *Please specify 'Other':
Branching Logic: If “Therapeutic Radiation Incident” selected for #104
210. Question: *Was this a systematic error that affected multiple patients?
Response Options:
- Yes
- No
Branching Logic: If “Therapeutic Radiation Incident” OR “Other Safety Incident” selected for
#104
211. Question: How many patients were affected by the error?
Response Options: Free Text
Branching Logic: If “Yes” selected for #210
212. 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 Options:
- ≤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. Question: How many fraction(s)/treatment(s) were delivered incorrectly?
Response Options: Free Text
Branching Logic: If response options 1-6 selected for #212
214. Question: How many total fractions were prescribed for the course of treatment?
Response Options: Free Text
Branching Logic: If response options 1-6 selected for #212
215. Question: *Was this event equipment related?
Response Options:
- Yes
- No
Branching Logic: None
216. Question: Simulation Equipment (Manufacturer) related to this event, if applicable:
Response Options: The response options are specific to each contract.
Branching Logic: If “Yes” selected for #215
217. Question: Treatment Planning Systems (Manufacturer) related to this event, if applicable:
Response Options: The response options are specific to each contract.
Branching Logic: If “Yes” selected for #215
218. Question: Treatment Management Systems (R&V) (Manufacturer) related to this event,
if applicable:
Response Options: The response options are specific to each contract.
Branching Logic: If “Yes” selected for #215
219. Question: Treatment Equipment: External Beam Photon/Electron (Manufacturer) related to
this event, if applicable:
Response Options: The response options are specific to each contract.
Branching Logic: If “Yes” selected for #215
220. Question: Treatment Equipment: Proton (Manufacturer) related to this event, if applicable:
Response Options: The response options are specific to each contract.
Branching Logic: If “Yes” selected for #215
221. Question: Treatment Equipment: Other (Manufacturer) related to this event, if applicable:
Response Options: The response options are specific to each contract.
Branching Logic: If “Yes” selected for #215
222. Question: *Do you want to report this event to the PSO?
Note: Selecting yes indicates that you are reporting this event and the associated follow up information 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 Options:
- Yes
- No
Branching Logic: None
223. Question: *Have you, or do you intend to, report this event outside of RO-ILS to fulfill
external reporting obligations (for example, NRC or state regulatory authorities)?
Note: Please be advised that information reported outside of your institution is no longer subject to the confidentiality provisions of the Patient Safety and Quality Improvement Act. In addition, even if not reported outside of your institution, if you are assembling, developing or preparing information for reasons other than reporting to the PSO this may remove the protected nature of this information and may require you to remove this from the PSES.
Response Options:
- Yes
- No
Branching Logic: None
224. Question: *To whom was the event reported? (Select all that apply)
Response Options:
- FDA
- NRC
- State
- Vendor/Manufacturer
- Other
- *Please specify 'Other':
Branching Logic: If “Yes” selected for #223
225. Question: *In terms of risk to patient safety, how significant was this event?
Response Options:
- Mild
- Moderate
- Severe
Branching Logic: None
226. Question: What might prevent future events like this?
Response Options: Free Text
Branching Logic: None
227. Question: What changes, if any, has the facility made in response to the event?
Response Options: Free Text
Branching Logic: None
228. Question: Please provide any additional details in the space provided below:
Response Options: Free Text
Branching Logic: None
229. Question: You may use this space for your internal use (i.e. internal tags):
Response Options: Free Text
Branching Logic: None
230. Question: Status:
Response Options:
- Submitted
- Closed
Branching Logic: None
231. Question: Contributing factors: (Select all that apply)
Response Options:
- Organizational Management
- Inadequate Resources
- Inadequate human resources
- Inadequate capital resources
- Policies, Procedures, Regulations
- Relevant policy nonexistent
- Policy inadequate
- Policy not followed
- Conflicting policies
- External regulation (e.g. state/federal) not followed
- Training
- Facility training inadequate
- Vendor-provided training inadequate
- Inadequate assessment of staff competencies
- Lack of continuing education
- Leadership and Culture
- Inadequate safety culture
- Failure to remedy past known shortcomings
- Hostile work environment
- Inadequate supervision
- Lack of peer review
- Outdated practices
- Physical Environment
- Physical environment inadequate
- Distractions or Interruptions in the environment
- Inadequate Resources
- 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
- Procedural issues
- 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)
- Failure to interpret the nature of the developing problem
- Inadequate search
- Missing information
- Incorrect information
- Failure to develop an effective plan to combat the problem
- Information not seen or sought
- Information misinterpreted
- Inappropriate assumptions
- Unintended consequences
- Failure to execute the planned action
- Plan started but not completed
- Plan misinterpreted
- Plan too complicated
- Inadequate quality assurance and quality control
- Failure to detect a developing problem or appreciate its nature/importance
- Technical
- 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)
- 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)
- 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
- 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
- Acceptance testing and commissioning
- 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
- Patient-focused circumstances
- Other
- *Please specify Other
Branching Logic: None
- *Please specify Other