Prevention of Medical Errors: Concepts and Tools. Perry Johnson, PhD April 30, 2016

Transcription

1 Prevention of Medical Errors: Concepts and Tools Perry Johnson, PhD April 30, 2016

2 Radiation Boom series by Walt Bogdanich 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 Error types Skill-based level (slips and lapses) Routine, well practiced actions or thoughts. Require little conscious attention. Rule-based level (RB mistakes) Following of a mental recipe or set of instructions. Pre-packed behavior released when appropriate rule is applied. Knowledge-based level (KB mistakes) Required action not readily apparent. Requires on-line problem solving.

4 Error types

5 Working memory Closely identified w/ attention and consciousness. Limited in nature many strategies/shortcuts can be viewed as devices for minimizing cognitive strain on WM.

6 Knowledge base Contains rules and information stored as schemata. Accessed via specific or general activators. Provides output either as an action or a thought to WM.

7 Strong-but-wrong When cognitive operations are under-specified, they tend to default to contextually appropriate, high frequency responses. Examples: Physician selects incorrect vaginal cylinder size (SB slip). Physicist measures small field OF w/ large ion chamber (RB mistake).

8 Knowledge based mistakes Knowledge based mistakes more difficult to predict. Frequency of schemata plays a large role. Bounded and reluctant rationality lead to cognitive biases: Out of sight out of mind. Confirmation bias. Overconfidence. Problems w/ causality and complexity. Hindsight bias. Etc..

9 Cognitive bias Knowledge of bias doesn t mean we can always compensate for it on our own! Shepard s table

10 Active failures Active and latent failures Effects felt almost immediately. Front-line operators in complex systems, i.e. Therapist, physicist, physicians. Latent failures Effects lay dormant only becoming evident when combined w/ other factors. Personnel removed both in time and space, i.e. Managers, physicist, physicians, engineers, designers. Poses greatest threat to safety of a complex system.

11 Active and latent failures

12 Process Mapping Flow chart Process tree

13 Process Mapping 1. Form a multidisciplinary group and designate a leader. 2. Determine the boundaries. 3. Study process and list the steps. 4. Sequence the steps. 5. Apply symbols to create an initial map. 6. Check w/ external sources and for completeness. 7. Iterate. 8. Finalize.

14 Failure Modes and Effects Analysis Purpose is to identify high priority failure modes along with their causes and effects. Prioritize worst offenders for FTA. Law of the vital few 80% of effects come from 20% of the causes.

15 Steps to FMEA 1. Map the process and identify major steps. 2. Identify failure modes for each step. 3. Identify effect(s) of failure mode. 4. Identify cause(s) of failure mode. 5. Assign a likelihood of occurrence rank to each cause (O). 6. Assign severity rank to each effect (S). 7. Assign a rank based on likelihood failure mode is not detected before effect occurs (D).

16 FMEA ranking systems

17 Failure Modes and Effects Analysis Risk Priority Number (RPN) = O x S x D Ranges from Focus QA resources on high RPN failure modes. Occurrence 1 (O 1 ) Occurrence 2 (O 2 ) Cause 1 Cause 2 Detectability (D) Failure mode Effect 1 Effect 2 Severity 1 (S 1 ) Severity 2 (S 2 )

18 Failure Modes and Effects Analysis

19 Fault Tree Analysis Process map FMEA Fault-tree-analysis.

20 Six key components: Affordances Signifiers Mappings Feedback Constraints Conceptual model Design with error in mind

21 Hierarchy of safety interventions 1. Forcing functions and constraints 2. Automation and computerization 3. Protocols, standardization, and design 4. Independent double checks and redundancies 5. Rules and policies 6. Education and information

22 Hierarchy of safety interventions 1. Forcing functions and constraints Robust defense mechanism. Usually have a low probability of failure. Examples: Door interlocks Key interlocks Collision detection ring Shielding

23 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 Automated patient monitoring systems Bar code scanners

24 Hierarchy of safety interventions 3. Protocols, standardization, and design Protocols improve communication and reduce the potential for knowledge based mistakes. By definition, standardization makes it easier to detect irregularities. Design is key component to human factors engineering. Examples: Labels, signs, and alarms Contouring templates Dose goal sheets Checklist

25 The Checklist Memory aid which makes minimum necessary steps explicit. Checklist can compel system change b/c often involve cultural change, i.e. shift in authority, responsibility, expectations, and discipline. Can improve outcome with no increase in technical skill. WHO surgical checklist major complications fell 36% and deaths 47% across eight hospitals. (N. Eng. J. Med, 360, , 2009) Keystone Initiative line infection rate fell from 7.7 per 1000 catheter days to 1.4. (N. Eng. J. Med, 355, , 2006)

26 A checklist for checklists

27 How to improve a checklist

28 Hierarchy of safety interventions 4. Independent double checks and redundancies Directly analogous to adding another layer of cheese Relatively inexpensive but highly effective. Many knowledge based mistakes can only detected by a second individual. Examples: Dosimetry audits Peer review Chart checks In-vivo dosimetry Comparison with standards Increased monitoring Machine QA

29 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

30 Hierarchy of safety interventions 6. Education and training Experience Education both formal and continuing Credentialing On the job training Support an active, exploratory approach. Trainee should have opportunity to both make errors and recover from them. OJB should include an aspect of formal qualifying.

31 Crew resource management Crew performance indicators Technical proficiency Team building Communication Workload management 31

32 Communication Effective communication: Clear, specific, concise and timely. Based on shared language and mental model. Invites participation and seeks information. 1) Sate critical information with appropriate level of persistence 2) Learn to sense another crew member s concern. 3) Make your position known when safety is in question. 4) Make sure your message is received and understood. 5) Don t hint and hope. 32

33 Communication Action statement: Address by name. State the problem or concern. Propose a solution. Seek agreement by posing challenge or confirming question. Don t you agree? With these concerns in mind, I'd like your thoughts on what options we have to improve the safety of this treatment. What do you think about 33

34 Situational awareness The perception of environmental elements with respect to time and space, the comprehension of their meaning, and the projection of their status into the future.

35 Barriers to situational awareness Perception based on faulty information processing Past information, expectations, filters. Excessive motivation Overriding sense of mission importance being in a hurry. Adapting to the needs of the patient. Overload and fatigue Causes distraction, fixation and loss of focus. Complacency Success breeds complacency. Complacency breads failure. Only the paranoid survive! Poor communication

36 Increasing situational awareness 1. Understand the baseline. 2. Be alert for deviations from standard procedures. 3. Learn to predict events. 4. Practice what-if scenarios. 5. Limit situational overload. 6. Fight normalcy bias. 7. Continually assess and reassess the situation. 8. Be proactive, provide information in advance. 9. Trust your gut. 10. Communicate effectively. Speak up if you have a question, don t downplay other s concerns.

37 Raising the threat level 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

38 Safety culture Communication openness. Feedback and communication about error. Frequency and number of events reported. Handoffs and transitions. Management support. Just culture in response to accidents. Organizational learning and continuous improvement. Overall perceptions of patient safety. Adequate staffing. Teamwork within and across units.

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40 Definition of a Just Culture Informed culture based on a Reporting culture based on a... Just culture Lies between punitive and blame-free culture. Distinction between acceptable and unacceptable behavior is both clear and understood. Human error vs. recklessness, negligence, and intentional rule breaking. Substitution test helps categorize action.

41 Incident Learning Systems 1. Generate immediate corrective action based on rootcause analysis. 2. Gather statistics on frequency of close calls/errors in order to trend data and anticipate problems. System SAFRON ROSIS RO-ILS Quantros Organization IAEA ESTRO ASTRO/AAPM Internal - UM Obligation No No No Yes Scope Broad Broad Broad Limited Identification Anonymous Anonymous Anonymous Identifiable Searchable Yes Yes - on request No Yes - limited access Protection International International PSO QA product

42 1. Preserve the scene Root Cause Analysis Screenshots, pictures, documentation, etc. 2. Form team and develop charter Specifies problem statement, scope, duration, resources, and membership. 3. Investigate (What happened) Physical inspection, testimony, review of documentation, etc. 4. Identify causal factors (How it happened) Rarely is there just one causal factor. Includes performance shaping factors. 4. Identify root causes (Why it happened) Rely on causal taxonomy to categorize causal factors 5. Implement/monitor recommendations

43 Creating an action plan 1. Eliminate, control, or accept. 2. Reduce occurrence/severity and increase detection. 3. Rely on hierarchy of safety interventions. 4. Develop immediate and long term corrections. 5. Designate who is responsible and empower them to make changes. 6. Set firm deadlines. 7. Establish outcome measures.

44 Safety profile assessment Online question-and-answer tool which allows user to assess clinical performance in key aspects of safety and quality. 92 questions carefully selected from various authoritative reports to assess performance in key, safety-critical areas.

45 Safety profile assessment Summary of your clinic's performance via visual pie charts.

46 Safety profile assessment Bar graphs allowing you to benchmark your performance against other participants. Annotated bibliography for further guidance on best practices and standards.

47 Questions?