National System for Incident Reporting in Radiation Therapy (NSIR-RT) Taxonomy

Transcription

1 Canadian Partnership for Quality Radiotherapy (CPQR) National System for Incident Reporting in Radiation Therapy (NSIR-RT) National System for Incident Reporting in Radiation Therapy (NSIR-RT) Taxonomy Canadian Association of Radiation Oncology Canadian Organization of Medical Physicists Canadian Association of Medical Radiation Technologists Canadian Partnership Against Cancer Canadian Institute of Health Information February 2, 2015 TAX

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3 Taxonomy Data Element Number Description Table 1: NSIR-RT Data Elements Data Fields and Menu Choices 1. Impact 1.1 Incident description Free text 1.2 Incident type Actual incident: Reached the patient, with or without harm Near miss: Detected before reaching the patient Reportable circumstance: Hazard not involving a patient 1.3 Acute medical harm (Adapted from the WHO-ICPS) Not applicable: Near miss or reportable circumstance None: Patient is asymptomatic and no treatment is required Mild: Symptoms if present are mild; no or minimal intervention (observation, investigation, minor treatment) is required; harm or loss of function is minimal, or intermediate but short term Moderate: Patient is symptomatic requiring intervention (additional treatment or operative procedure) or a prolonged hospital stay; long term or permanent harm or loss of function Severe: Patient is symptomatic requiring life-saving intervention or a major surgical/medical intervention; shortened life expectancy, or major long term or permanent harm or loss of function Death: On the balance of probabilities, death was caused or brought forward in the short term by the incident. 1.4 Dosimetric severity Not applicable: Near miss or reportable circumstance Minor: 5% tumour underdose or OAR overdose, relative to the intended doses to these structures over the course of treatment Moderate: >5% and 25% tumour underdose or OAR overdose, relative to the intended doses to these structures over the course of treatment Severe: >25% tumour underdose or OAR overdose, relative to the intended doses to these structures over the course of treatment 1.5 Latent medical harm Not applicable: Near miss or reportable circumstance 3

4 Yes: On the balance of probabilities, the incident is likely to be associated with the development of significant late medical harm. No: On the balance of probabilities, the incident is unlikely to be associated with the development of significant late medical harm. 2. Discovery 2.1 Functional work area Field to be customized for individual programs 2.2 Date incident was detected DD:MMM:YYYY 2.3 Date incident occurred DD:MMM:YYYY 2.4 Time or time period when the incident was detected 2.5 Time or time period when the incident occurred 2.6 Health care provider(s) and/or other individual(s) who detected the incident HH:MM 00:00-3:59 04:00-07:59 8:00-11:59 12:00-15:59 16:00-19:59 20:00-23:59 HH:MM 00:00-3:59 04:00-07:59 8:00-11:59 12:00-15:59 16:00-19:59 20:00-23:59 Radiation therapist Treatment planner or dosimetrist Medical physicist Radiation oncologist Radiation oncology resident or fellow 4

5 (Multiple selections as warranted) 2.7 Health care provider(s) and/or other individuals(s) involved in the incident (Multiple selections as warranted) 3.1 Patient year of birth YYYY 3.2 Patient month of birth MM 3.3 Patient gender Male Female Undifferentiated Unspecified 3.4 Diagnosis relevant to treatment Staff doing technical maintenance Nurse or physician assistant Non-MD student or trainee Administrator Patient or family member Radiation therapist Treatment planner or dosimetrist Medical physicist Radiation oncologist Radiation oncology resident or fellow Staff doing technical maintenance Nurse or physician assistant Non-MD student or trainee Administrator Patient or family member 3. Patient Breast cancer Central nervous system tumors Gastrointestinal cancer Genitourinary cancer Gynecological cancer Lymphoma or leukemia 5

6 4.1 step where the incident occurred 4.2 step where the incident was detected 4.3 Problem type (Single descriptor that best characterizes the incident) Melanoma/Non-melanoma skin cancer Sarcoma Thoracic malignancy Benign 4. Details Patient assessment/consultation Imaging for radiotherapy planning Treatment planning Pre-treatment review and verification Treatment delivery On-treatment quality Post-treatment completion Patient assessment/consultation Imaging for radiotherapy planning Treatment planning Pre-treatment review and verification Treatment delivery On-treatment quality Post-treatment completion Adverse Event Allergic reaction Adverse Event Break in sterile technique Adverse Event Patient fall or injury Adverse Event Equipment collision Adverse Event Equipment malfunction Accessory Incorrect bolus Accessory Incorrect immobilization device Accessory Incorrect shielding/mlc Accessory Incorrect accessory tray Accessory Incorrect electron accessories 6

7 4.4 Contributing factors (Multiple selections as warranted) Accessory Accessory Documentation Documentation Documentation Documentation Documentation Dose Dose Dose Dose Treatment volume Treatment volume Treatment volume Treatment volume Treatment volume Treatment volume Treatment volume Imaging Imaging Imaging Scheduling Scheduling Fiducial markers Couch Incorrect treatment plan Incorrect setup instructions Incorrect treatment delivery parameters Incorrect record of treatment Missing or incomplete documentation Incorrect prescription Incorrect plan dose Calibration error Calculation error Incorrect patient Incorrect anatomical site Incorrect side (laterality) Incorrect target or OAR contours, or incorrect planning margins Incorrect patient positioning Incorrect shift from setup point Patient movement during simulation or treatment Incorrect simulation imaging Incorrect image fusion Incorrect on-treatment imaging Radiation treatment scheduling error Combined modality treatment scheduling error (concurrent radiotherapy and chemotherapy) Programmatic resources Training Communication 7

8 Documentation Policies, procedures, regulations - Inadequate Policies, procedures, regulations Not followed Environment - Competing demands Environment - Inadequate safety culture Environment Not conducive to safety Environment - Physical environment Leadership - Inadequate supervision Failure to detect - Expectation bias Failure to detect - Non- standard technique Failure to detect - Distraction, loss of attention Failure to interpret - Missing information Failure to interpret - Incorrect information Failure to interpret - Information misinterpreted Failure to navigate - Information not seen or sought, inappropriate assumptions Failure to navigate - Mistaken options Failure to execute - Plan forgotten in progress Failure to execute - Inadequate of change Failure to execute - Incomplete, invalid, or faulty rule Technical Acceptance testing and commissioning Technical Equipment issues Patient-related circumstances Factors beyond facility control (Reportable circumstance) 8

9 Number of patients affected 1 More than 1 5. Delivery 5.1 Radiation treatment technique (Multiple selections as warranted) External beam photon radiotherapy - Simple External beam photon radiotherapy - 3D conformal External beam photon radiotherapy - IMRT External beam photon radiotherapy - SRS External beam photon radiotherapy - SBRT External beam photon radiotherapy - Modulated arc therapy External beam photon radiotherapy - Orthovoltage External beam electron radiotherapy Brachytherapy - Intracranial, intraluminal, intravascular, surface Brachytherapy - Interstitial Brachytherapy LDR Brachytherapy PDR Brachytherapy HDR Brachytherapy - Temporary implant Brachytherapy - Permanent implant 5.2 Total dose prescribed NN.NN Gy Not applicable 5.3 Number of fractions prescribed NN Fractions Not applicable 5.4 Number of fractions delivered incorrectly NN Fractions Not applicable 5.5 Hardware involved (if relevant) Yes (Free text - specify manufacturer and model) No 5.6 Software involved (if relevant) Yes (Free text - specify manufacturer and model) No 5.7 Body region(s) treated Brain Spine Head and neck 9

10 (Multiple selections as warranted) Thorax Abdomen Pelvis Upper extremity Lower extremity Skin 5.8 Treatment intent Curative (Radical) Palliative 6.1 Ameliorating actions (to make better or compensate harm after an incident) 6.2 Safety barrier(s) that failed to prevent the incident (Multiple selections as warranted) 6. Investigation Free text apologize, clinical of an injury, radiation treatment replanning, change in prescription dose-fractionation, staff debriefing, culture change Verification of patient ID Verification that all relevant clinical information (diagnosis and staging, comorbid conditions, pacemaker, defibrillator, prior RT) were taken into account Verification of imaging data for planning (appropriate imaging, image fusion, correct image data set(s)) Verification of reference points Oncologist peer review Radiation therapist review of treatment plan Physicist review of treatment plan Oncologist review of treatment plan Independent confirmation of dose Time out/verbalization/call-back Verification of treatment accessories Regular chart check Intra-treatment monitoring (audio/visual, motion tracking) Regular on-treatment clinical (physician) assessment Post-treatment assessment 10

11 6.3 Safety barrier(s) that prevented the incident (Multiple selections as warranted) None Regular internal audit Pacemaker or implantable devices check Pregnancy check Informed consent Laterality check Use of record and verifying system Image-based position verification Image-based accessory verification Independent review of commissioning Equipment protection system (collision detection devices) Emergency shutdown Interlocks Regular equipment performance verification Regular external audit Verification of patient ID Verification that all relevant clinical information (diagnosis and staging, comorbid conditions, pacemaker, defibrillator, prior RT) were taken into account Verification of imaging data for planning (appropriate imaging, image fusion, correct image data set(s)) Verification of reference points Oncologist peer review Radiation therapist review of treatment plan Physicist review of treatment plan Oncologist review of treatment plan Independent confirmation of dose Time out/verbalization/call-back Verification of treatment accessories Regular chart check Intra-treatment monitoring (audio/visual, motion tracking) Regular on-treatment clinical (physician) assessment 11

12 6.4 Actions taken or planned to reduce risk, and other recommendations None Free text Post-treatment assessment Regular internal audit Pacemaker or implantable devices check Pregnancy check Informed consent Laterality check Use of record and verifying system Image-based position verification Image-based accessory verification Independent review of commissioning Equipment protection system (collision detection devices) Emergency shutdown Interlocks Regular equipment performance verification Regular external audit WHO-ICPS World Health Organization Conceptual Framework for the International Classification of Patient Safety 12

13 Table 2: NSIR-RT Mandatory and Optional Reporting Requirement Number Taxonomy Data Element Description Actual Incident Near Miss Reportable Circumstance 1. Impact 1.1 Incident description Mandatory Mandatory Mandatory 1.2 Incident type Mandatory Mandatory Mandatory 1.3 Acute medical harm Mandatory Not applicable Not applicable 1.4 Dosimetric severity Mandatory Not applicable Not applicable 1.5 Latent medical harm Mandatory Not applicable Not applicable 2. Discovery 2.1 Functional work area Mandatory Mandatory Mandatory 2.2 Date - detected Mandatory Mandatory Mandatory 2.3 Date - occurred Optional Optional Optional 2.4 Time - detection Mandatory Mandatory Mandatory 2.5 Time - occurred Optional Optional Optional 2.6 Health care provider(s) - detected Optional Optional Optional 2.7 Health care provider(s) - involved Optional Optional Optional 3. Patient 3.1 Patient year of birth Optional Optional Not applicable 3.2 Patient month of birth Optional Optional Not applicable 3.3 Patient gender Mandatory Optional Not applicable 3.4 Diagnosis relevant to treatment Mandatory Mandatory Not applicable 4. Details 4.1 step - occurred Mandatory Mandatory Mandatory 13

14 4.2 step - detected Mandatory Mandatory Mandatory 4.3 Problem type Mandatory Mandatory Mandatory 4.4 Contributing factors Mandatory Mandatory Mandatory 4.5 Number of patients affected Mandatory Not applicable Not applicable 5. Delivery 5.1 Radiation treatment technique Mandatory Mandatory Mandatory 5.2 Total dose prescribed Mandatory Mandatory Not applicable 5.3 Number of fractions prescribed Mandatory Mandatory Not applicable 5.4 Number of fractions delivered incorrectly Mandatory Not applicable Not applicable 5.5 Hardware involved Mandatory (if relevant) Mandatory (if relevant) Mandatory (if relevant) 5.6 Software involved Mandatory (if relevant) Mandatory (if relevant) Mandatory (if relevant) 5.7 Body region(s) treated Mandatory Optional Not applicable 5.8 Treatment intent Optional Optional Not applicable 6. Investigation 6.1 Ameliorating actions Mandatory Mandatory Optional 6.2 Safety barriers - failed Mandatory Mandatory Optional 6.3 Safety barriers - detected Mandatory Mandatory Optional 6.4 Actions and recommendations Optional Optional Optional 14