Medical Error Prevention

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1 Medical Error Prevention Matthew Studenski, PhD September 9, 2016 Disclosures Nothing to disclose. 1

2 Medical Error Prevention Definition of a medical event Look back on human error assessment Current recommendations Case studies What can we do? Medical Error Prevention 2

They Check the Medical Equipment, but Who Is Checking Up on Them?

3 Medical Error Prevention Medical Error Prevention At V.A. Hospital, a Rouge Cancer Unit The Radiation Boom Stereotactic Radiosurgery Overdoses Harm Patients They Check the Medical Equipment, but Who Is Checking Up on Them? Case Studies: When Medical Radiation Goes Awry Radiation Offers New Cures, and Ways to Do Harm A Pinpoint Beam Strays Invisibly, Harming Instead of Healing As Technology Surges, Radiation Safeguards Lag 3

4 Required by Florida Law: Medical Error Prevention 64B Continuing Education Requirements. (1) Licensees must complete at least 24 hours of approved continuing education for each biennium, including one hour relating to transmission and prevention of HIV/AIDS and two hours relating to prevention of medical errors. (2) Licensees may claim one credit hour per biennium for lecturing or authoring course materials for an approved continuing education program. Rulemaking Authority , (6)(a) FS. Law Implemented , , (6)(a) FS. History New , Amended , , Medical Event Florida Administrative Code 64E situations: 1. Radioactive materials or radiation from radioactive materials requiring a written directive 2. Radioactive materials or radiation from radioactive materials not requiring a written directive 3. Radiation from a therapeutic x ray machine or particle accelerator 4

5 Medical Event 1. Radioactive materials or radiation from radioactive materials requiring a written directive Total dose delivered differs from the prescribed dose by 20% The fractionated dose delivered for a single fraction by 50% Wrong radioactive drug containing radioactive material Wrong route of administration Wrong individual or human research subject Wrong mode of treatment A leaking sealed source Any medical use that results or will result in unintended permanent functional damage to an individual s organ or a physiological system, as determined by a physician *excluding, for permanent implants, seeds that were implanted in the correct site but migrated outside the treatment site Medical Event 2. Radioactive materials or radiation from radioactive materials not requiring a written directive Total dose delivered differs from the prescribed dose by 20% The fractionated dose delivered for a single fraction by 50% Wrong radioactive drug containing radioactive material Wrong route of administration Wrong individual or human research subject Wrong mode of treatment A leaking sealed source Any medical use that results or will result in unintended permanent functional damage to an individual s organ or a physiological system, as determined by a physician 5

6 Medical Event 3. Radiation from a therapeutic x ray machine or particle accelerator Any medical use that results or will result in unintended permanent functional damage to an individual s organ or a physiological system, as determined by a physician Wrong individual or human research subject Wrong mode of treatment Wrong treatment Wrong treatment site Three or fewer fractions, the total prescribed dose differs by more than 10% Weekly administered dose is >30% Total prescribed dose differs by >20% Medical Errors Legal Definition Medical Event Medical Error Near Miss Doesn t surpass the threshold Multiple errors might lead to an event 6

7 AAPM Definitions Error Failure to complete a planned action as intended Incident An unwanted or unexpected change from normal system behavior which causes or has the potential to cause an adverse effect to persons or equipment Adverse Event (Medical Event) An incident that occurs during the process of providing healthcare that results in suboptimal clinical outcome including unintended injury or complication leading to disability, death, or prolonged hospital stay for the patient Human Errors 7

8 Human Errors Designed for industrial (nuclear) industry but can be applied to medical industry Paradigm shift from analyzing the task towards analyzing the human performing the task Historically, it was assumed that human error could be remedied with training Human Errors Environment Resources available (physical, staff) Personal factors History Equipment performance Timing 8

9 Human Errors Human Errors 9

10 Action Choices Skill based routine, no brainer Recognition Misidentification Non detection Slips\memory lapses Rule Based follow a recipe Misapplying a good rule Applying a bad rule Knowledge Based online problem solving Tackling unfamiliar problems Rules Remembered or recalled Read from a manual Slower than skill based actions New rules can fall into the knowledge domain 10

11 Action Domains Humans tend to go with skill based choices first Familiarity is high Reliability is high Rule based comes next Rules govern choices Less practice Less familiarity Knowledge based is only resorted to when no rule can be found Dependent on individual Dependent on skill Human Errors 11

12 Human Errors How can this help me? WHY?? MEDICAL EVENT HOW? WHAT? Human Errors External factors What task was performed? Why it failed How it failed What failed? Medical Event 12

13 Human Errors Human Errors 13

Concept of Error Prevention We must understand the error to properly address it Humans can err for many reasons A solution for a problem might not work if the cause is

14 Concept of Error Prevention We must understand the error to properly address it Humans can err for many reasons A solution for a problem might not work if the cause is different than believed Critical to differentiate the cause of the error Concept of Error Prevention *Courtesy of Todd Pawlicki, 48 th Annual Meeting, AAPM, Orlando FL

15 Why do Human Errors Happen? Increased complexity in treatments Evolving technology Lack of knowledge/education/information Poor communication Time shortage or fatigue Equipment failure Poor procedures Wrong person doing the wrong task Lack of proper equipment Inattention or distraction Relying heavily of technology Why do Human Errors Happen? Errors can occur when the usual process breaks down Look for warnings signs Requires constant monitoring Team effort 15

16 Action Domains Skill Based Errors Literature Towards Safer Radiotherapy (Britain) Radiotherapy Risk Profile (WHO) Preventing Accidental Exposure in Radiotherapy (IAEA) Improving Patient Safety in Radiation Oncology (Med. Phys. 2011) Safety is No Accident (ASTRO) TG 100 (AAPM) 16

17 Recommendations 12 specific problems were cited in multiple documents: Training Staffing Documentation Incident learning system Communication Checklists QA and PM Domestic Audit Accreditation Minimizing interruptions Prospective risk assessment Safety culture *Courtesy of Peter Dunscombe, PhD, AAPM Summer School, 2013 Hierarchy of safety interventions 1. Forcing functions and constraints STRONG 2. Automation and computerization 3. Protocols, standardization, and design 4. Independent double checks and redundancies 5. Rules and policies 6. Education and information WEAK 17

18 Hierarchy of safety interventions 1. Forcing functions and constraints Robust defense mechanism Usually have a low probability of failure Forces consciousness to operator Not always practical Examples: Door interlocks Key interlocks Collision detection ring Hierarchy of safety interventions 2. Automation and computerization Reduces the need for human intervention Over-reliance can lead to complacency Examples: Record and verify systems Bar code scanners 18

19 Hierarchy of safety interventions 3. Protocols, standardization, and design Protocols reduce the potential for knowledge based mistakes by implementing rules By definition, standardization makes it easier to catch outliers Examples: Contouring templates Dose goal sheets Checklist Hierarchy of safety interventions 4. Independent double checks and redundancies Relatively inexpensive but highly effective Many knowledge based mistakes can only detected by a second individual (HDR planning) Examples: Dosimetry audits Peer review Chart checks In-vivo dosimetry Machine QA 19

20 Hierarchy of safety interventions 5. Rules and policies Often one of the first actions taken to address a problem Can be effective but requires both adherence and feedback Includes administrative aspects Examples: Staffing and scheduling Departmental policies Sterile cockpit principle Time-out procedures Hierarchy of safety interventions 6. Education and training Also one of the first attempts to solve a problem Credentialing On the job training Support an active, exploratory approach Trainee should have opportunity to both make errors and recover from them 20

21 Training Recognize difference between competency and being trained Training teaching a particular skill or behavior Competency ability to do something successfully or efficiently Training is only as good as the trainer and the trainee In one ear and out the other Do not train for the sake of training Bad training is worse than no training Need well designed systems Recommendations 12 specific problems were cited in multiple documents: Training (7) Staffing (6) Documentation (5) Incident learning system (5) Communication (4) Checklists (4) QA and PM (4) Domestic Audit (4) Accreditation (4) Minimizing interruptions (3) Prospective risk assessment (3) Safety culture (3) *Courtesy of Peter Dunscombe, PhD, AAPM Summer School,

22 Recommendations STRONG Safety Culture Checklist QA Audit Accreditation Risk Assessment Staffing Communication Minimize Interruptions WEAK Training Documentation Recommendation Safety Culture An incident must not be seen as a failure or crisis, neither by management, nor by colleagues. An incident is a free lesson, a great opportunity to focus attention and to learn collectively. Sidney Dekker, Just Culture Leadership Change must start from top Avoid downward pressure Not invulnerable Management No micro-managing Do not instill fear Build strategy Team building Essential for strong culture Avoid individualization (hoarding tasks) Conflict resolution Strong team Avoid impulsiveness Communication Open routes\written reports 22

23 Safety Culture *Courtesy of Perry Johnson, PhD, FLAAPM Spring Meeting, 2016 Safety Culture What is our role? Physicists play a central role in department Help monitor team members Look for hazard traits in individuals Complacency Impulsiveness Human error vs. recklessness\negligence Take pre-emptive action if something seems off Help create action plans Don t make excuses! Tired Too busy 23

$Safety Culture Case Study 1 Single fraction TBI (200 cgy) Last minute addition at 6PM due to change in bone marrow transplant No other physicists to double check (standard$

24 Safety Culture Case Study 1 Single fraction TBI (200 cgy) Last minute addition at 6PM due to change in bone marrow transplant No other physicists to double check (standard protocol) Plan approved by physician and physicist and treatment delivered, patient sent back to room Therapist calls physicist stating the diode reading was only 100 cgy 24

25 Case Study 1 Spreadsheet calculation Per field dose was used instead of prescription dose Patient brought back down and remaining 100 cgy was delivered Error type: Skill based Mental slip Rushed Did not follow normal protocol Fatigue Case Study 1 Checks in place to catch error In vivo dosimetry Double check Root cause: No double check Rushed case\fatigue Physicist\physician\therapist did not notice big difference in MUs Special treatment, should have been more than 3 people involved 25

26 Case Study 2 Case Study 2 Incorrect step size Multi catheter plan Step size had to be entered manually Underdose to patient between 47 64% Corrective action: Changes to procedures Verify that programmed parameters agree with plan and written directive Training 26

27 Case Study 2 Incorrect measurement of catheter tip distance Multi catheter plan Dose delivered to unintended site (skin necrosis in one case) Root cause of one event was determined to be a broken source position simulator Corrective action: Changes to procedures Double check of measurement Post a table of common catheter lengths Training Case Study 2 Incorrect reference point Tip end vs. catheter end Dose delivered to unintended site Corrective action: Changes to procedures Double check Training 27

28 Case Study 2 Incorrect treatment setup Wrong catheter type connected for endobronchial treatment Dose delivered to unintended site Corrective action: Changes to procedures Time out to confirm correct connection Comprehensive instruction manual Training Case Study 2 Incorrect treatment plan Two patients scheduled, wrong plan delivered Root cause determined to be operator error and failure to reprogram unit Corrective action: Changes to procedures Time out verify patient identity Training 28

received 69% of prescription and OAR did not differ by more than 50%

29 Case Study 2 Incorrect applicator placement Vaginal cylinder inserted in rectum Actually not a reportable medical even as intended treatment site received 69% of prescription and OAR did not differ by more than 50% Corrective action: Changes to procedures Double check applicator placement Case Study 2 29

30 Case Study 2 Human Error is not a root cause! WHY? HOW? WHAT Case Study 2 All corrective action was similar Change procedure Double checks Training Might have been some underlying causes missed Safety culture 30

31 Case Study 3 Patient being treated with SRS cones R&V system had correct parameters but a fault was preventing beam on BrainLab was relying on this R&V interlock alone to interlock collimator Physicist called and modified the R&V parameters to clear interlock Did this for 2 more patients Case Study 3 Patient was treated with collimator jaws set at 10x10 leading to a large overdose Two subsequent patient treated this way as well Error type: Knowledge based Safety checks in place R&V system Root cause: Did not follow normal QA protocol (quick fix) Not trained in this type of treatment, found a fix and made it procedure without review 31

32 Case Study 4 Patient being treated to the oropharynx using IMRT Initial plan is created and treatment commences properly QA is done and passes Fractions 1 4 are delivered properly Several days into treatment the physician wants to modify the plan to reduce dose to the teeth Plan is re optimized but during the process a step is skipped leading to the leaf segmentation being lost (user ignored error message) Case Study 4 The patient was treated for 3 fractions before a QA plan was run Operator notices that MLC leaves are missing This error meant that the patient received 13 Gy in each of these three fractions vs. the prescription dose of 2.2 Gy 32

33 Case Study 4 Error type: Skill based Multiple errors led to the medical event: The physician approved this new plan without thorough review No one looked into the computer crashes Same physicist reviewed the plan before delivery The therapist did not pay attention at the machine Departmental protocol allowed 3 fractions w/o QA Root cause? Case Study 4 The physician approved this new plan without thorough review Same physicist reviewed the plan before delivery Rushed? Fatigued? Carelessness? Protocol? Solutions: Physics checklist Better plan documentation Physician review (morning chart rounds) 33

34 Case Study 4 No one looked into the computer crashes Communication? Correct person not notified? Carelessness? Solutions: Have a point person to review error messages Have a central database for errors Training and instruction to not simply click Ok Case Study 4 The therapist did not pay attention at the machine Not trained properly? Overworked? Distractions? Only 1 therapist per machine? Solutions: Ensure proper staffing levels Proper training Sterile cockpit Make sure therapists know who to talk to 34

35 Case Study 4 Departmental protocol allowed 3 fractions w/o QA Who implemented\approved this? What other QA checks in place? Solutions: Use 2 nd check software or log files for initial fractions See what other institutions are doing Red Flags for Medical Physicsts Most common errors are skill based Some errors involve new or special procedures (knowledge based) As physicists we should have some triggers: 1. New equipment/software 2. Upgrades of equipment/software 3. Repair of equipment 4. Software crash 5. New or infrequent technique 6. Change in procedure/protocol 7. New personnel 8. Re-planning 9. Re-treatment 10. Hypo-fractionation/high dose 35

36 Hazards to Medical Physicists Organizational Low professional standing No access to education, training, or credentialing Excessive workload Unrealistic scheduling Inadequate peer review Push for research Professional Failure to manage systems Arrogance\hubris Carelessness\indifference Moving Forward Where does this leave us? Will things improve? Yes? - Better tools & more awareness No? - Decrease in reimbursement and staffing What to do in your clinic? Reward staff for catching errors Improve training and communication Make errors available to others Discuss new technology with other users External audits (RPC) Robust acceptance and commissioning 36

37 Think about this Thank you! Any Questions? 37

VA Radiotherapy Incident Reporting and Analysis System (RIRAS)

VA Radiotherapy Incident Reporting and Analysis System (RIRAS) Jatinder R Palta PhD Rishabh Kapoor MS Michael Hagan, MD National Radiation Oncology Program(10P11H) Veterans Health Administration Disclosure