A Guide for Root Cause Analysis Teams

Acknowledgements
The Queensland Health Patient Safety Centre (PSC) acknowledges the Veterans Health Administration National Center for Patient Safety (NCPS) who developed the original concept for this Root Cause Analysis cognitive aid. The PSC acknowledges the NSW Department of Health for their work in creating guidelines for Root Cause Analysis. The PSC also thanks the many individuals who contributed to the development of these guidelines. This includes, but is not limited to: Patient Safety Managers Patient Safety Officers

2009 Queensland Health

This work is copyright. It may be reproduced in whole or in part for study and training purposes subject to the inclusion of an acknowledgement of the source. It may not be reproduced for commercial, usage or sale. Reproduction for purposes other than those indicated above requires written permission from Queensland Health. Enquiries concerning this document and its reproduction should be directed to: Patient Safety Centre Level 14, Block 7 Royal Brisbane and Womens Hospital PO Box 152 Herston QLD 4029 Telephone: +61 7 3636 9711 Email:psc@health.qld.gov.au Internet:http://www.health.qld.gov.au/patientsafety
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Introduction
The conduct of Root Cause Analysis (RCA) by public and private health service entities is governed by the following Queensland legislation: Health Services Act (Qld) 1991 Part 4B Health Services Regulation (2002) Part 6A Ambulance Service Act (1991) Part 4A http://www.legislation.qld.gov.au/OQPChome.htm RCA teams must be appointed by a Commissioning Authority in accordance with the relevant legislation. RCA team members must: (i) have the appropriate skills, knowledge and experience to conduct a RCA of the event, having regard to the nature of the event; and (ii) not be directly involved in providing the health (or ambulance) service at a health service facility during the provision of which the event happened. There are some cases where RCA is not appropriate. RCA must not be commenced or must be stopped where the following is reasonably believed: A Blameworthy Act: (a) an intentionally unsafe act; (b) deliberate patient abuse; (c) conduct that constitutes a criminal offence.

or that the clinician has a physical or mental impairment, disability, condition or disorder (including substance abuse) which affects their capacity to provide safe care.

If the RCA team becomes aware of any of the above, they must discuss with the Commissioning Authority their concern.
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RCA Process Meeting 1 Develop Initial Flow Diagram

Meeting 2

1. Complete Flow Diagram

2. Develop Contributing Factors Diagram

3. Develop Causal Statements

Quality Check Opportunity at PSC

Meeting 3

Develop recommendations and outcome measures

Quality Check Opportunity at PSC

Meeting 4

Complete the RCA report

Presentation of the RCA report to Commissioning Authority

Instructions
Important Note: Chain of Events Documents (under Part 4B Section 38M of the Health Services Act (Qld) 1991, or Part 4A Section 36G of the Ambulance Service Act (Qld) 1991); consists of: 1. Flow Diagram 2. Contributing Factors Diagram
Instructions

Meeting 1 - Initial Flow Diagram

The purpose of meeting 1 is to construct a basic time series of the facts leading up to and including the adverse outcome.
Day/Date/Time Location -Assessment -Observations -Impression -Plan Day/Date/Time Location -Assessment -Observations -Impression -Plan a Day/Date/Time Location -Assessment -Observations -Impression -Plan

1. The RCA team constructs an initial Flow Diagram. Try to limit the diagram to five or six boxes (where possible) and include only the key events that are crucial to an understanding of what happened. 2. As the flow diagram develops, the RCA team will raise questions and more information will be required in order to understand what has occurred. The triage questions on page 18 will help you consider additional factors. Ask how, what and why at each event in the initial Flow Diagram. This will help you understand the incident and what extra information you need to learn to describe what happened.

3.

4. Develop a Team Action Plan - Identify what additional information you need in order to understand what happened, and decide who is going to collect the information. Plan to have at least 1 week between meetings. 5

Instructions Instructions
Key Issues for Meeting 1
It is important to note:

1. The Flow Diagram captures known facts only and must be verifiable by a. Clinical notes b. Witness interviews.

2. The RCA team must identify and interview all relevant staff involved (with the consent of those staff). 3. It is strongly recommended that the RCA team visit the physical area where the event occurred to inspect equipment or to take photographs etc. 4. The RCA team will collect and view District and organisational policies and procedures relevant to the event. 5. The RCA team should collect and consider relevant publications, standards and published evidence. 6. The RCA team must use the triage questions (p. 18) to ensure all common problems are reviewed.

Instructions
Meeting 2 - Final Flow and Contributing Factors Diagram
Final Flow Diagram 1. Once all the information has been gathered, the team can construct the final Flow Diagram. This is a more detailed chronology of what happened. More information = more boxes. 2. At each point in the final Flow Diagram, the team should ask so what? or what is the relevance? of each box in the chain. 3. The team should identify whether barriers could be inserted along the chain. A barrier identifies a point at which the incident may have been prevented. Signify the barrier by a red box and suggest what preventative actions could be included in this barrier. A barrier may signal either a root cause recommendation or a lesson learnt. See page 7 for tips on developing barriers.

Tip: Dont jump to conclusions. It is essential to stay focussed on what actually happened not what the team thinks happened.

Day/Date/ Time Location -Assessment -Observations -Impression -Plan

Day/Date/ Time Location -Assessment -Observations -Impression -Plan

Day/Date/ Time Location -Assessment -Observations -Impression -Plan

Barrier

Developing Barriers
Step 1 - Identify the gap
A gap is where an element of care stands out within the chain of events as something that did not occur as it usually should happen or as best practice recommends. A check must be made to ensure all the facts have been obtained before the gap is confirmed.
Example: There was no Electrocardiogram (ECG) taken when the patient presented with chest pain.

Step 2- Develop the reason

Once the facts have been determined then the question must be why?
Example: Analysis found that the ECG machine in the department was old and unreliable and had a defective battery, so a decision was made to delay the investigation until arriving in the ward

Step 3- Develop a barrier (possible solution)

There are no strict rules as to what might be the best solution and the team can decide this. Refer to strong, intermediate and weaker actions on page 16.
Examples: Replace ECG machine with a new one - strongest Replace battery of old machine - intermediate Poster checklist on troubleshooting the operations of the unreliable ECG machine - weakest

Instructions
Meeting 2 - Final Flow and Contributing Factors Diagram
Contributing Factors Diagram CFD The team must outline the real problem to be eliminated. The Problem Statement is best constructed as a short verb/noun statement. For Example: Problem Statement: Fractured Hip

The team should then brainstorm the Barriers (red boxes) identified in the final Flow Diagram and use these as the immediate causes that contributed to the Problem Statement. 4. The Contributing Factors Diagram can now be constructed. This helps to explain why the incident happened. It also helps to illustrate the relationship between the causal links and reveals the contributing factors and root causes. 5. Continue to ask why after each contributing factor box until there are no more answers. As a general rule, asking why 4 or 5 times from the problem statement will result in a root cause.

Tip: Root causes should be so directly relevant that if the root causes were removed, the event would most likely have not occurred!

Instructions
Meeting 2 - Final Flow and Contributing Factors Diagram
Contributing Factors Diagram

Immediate Factors

Intermediate Factors

Root Cause

Problem Statement

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Instructions
Meeting 3 explaining why it happened
Developing Causal Statements 1. Identify and prioritise root causes from the Contributing Factors Diagram. 2. Write Causal Statements based on the root causes identified in the Contributing Factors Diagram. (Aim for no more than 3-4 causal statements to address those that are most likely to prevent OR reduce the likelihood of this event from occurring in the future). 3. Check Causal Statements are consistent with the Five Rules of Causation (pages 12-14). Causal Statements- sample phrase: Due to the root cause, the intermediate factor occurred which led to the next intermediate factor, increasing the likelihood of the immediate factor and may have contributed to the problem statement.

Making recommendations

1. Develop Corrective Actions/Recommendations for each Causal Statement. These are aimed at preventing the cause. 2. Your recommendations should be specific and achievable. 3. Identify the position within the health service facility accountable for each recommendation. 4. State a realistic time frame for implementation.

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Instructions
Meeting 3 explaining why it happened
Making recommendations- continued 1. Identify how the impact of the recommendation will be measured for effectiveness. Eg: 100% compliance over 3-6 months. 2. Complete draft RCA report.

Tip: Discuss the draft recommendations with the person who reported the incident to see if they believe that the RCA team is on the right track. Q If these recommendations were in place at the time of the incident, do you think it likely that the incident may have been prevented from occurring? Meeting 4 writing the report
An additional meeting may be a useful time for the RCA team to review the final RCA report, make any final amendments and sign it before it is presented to the Commissioning Authority.

Important
The RCA meeting schedule provided is only a guide and the number of meetings required will depend upon the complexity of the individual case.

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5 Rules of Causation
Contributing factor statements must clearly address why something has occurred and there must be a clear focus on process and system vulnerabilities, never on individuals. The following Five Rules of Causation will help the RCA team develop robust contributing factor and root cause statements.

Rule 1
5 Rules of Causation

Causal statements must clearly show a cause and effect relationship 1. If the contributing factor / root cause is eliminated or controlled, will this likely prevent or minimise it happening again? 2. The statement should show the link between a root cause and the harm to the patient. It must be clear, easy to read and show exactly how what happened, contributed to the harm. Example Not clear - The resident medical officer was fatigued. Clear - The level of medical officer fatigue increased the likelihood of the instructions being misread, which led to incorrect tube insertion.

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5 Rules of Causation
Rule 2
Use specific and accurate descriptors for what occurred, rather than negative and vague words Negative descriptions are not helpful and should not be used. Avoid words such as poorly, inadequately, haphazardly, carelessness, and complacency. These are too broad, and negative judgements dont describe the actual conditions or behaviours that led to the harm.
Example Not clear - Poorly trained nurse. Clear - The absence of nursing induction training in IV pump operation increased the likelihood that the IV pump was incorrectly programmed, which led to the patient receiving twice the prescribed quantity of dopamine.

Rule 3
Identify the preceding system causes not the human error Patient harm often involves a set of events and errors, so for every human error in the causal chain, there must be a corresponding cause. Much like Rule 1, the links need to be clear and obvious to the readers of the RCA. Establishing the cause of the error, not the error itself, will lead to prevention.
Example Not clear - The medication was not administered as prescribed. Clear - The lack of a structured handover system between nurses contributed to unclear responsibility for medication which led to the patient not receiving medication as prescribed. 14

5 Rules of Causation
Rule 4
Identify the preceding system causes of procedure violations. Procedural violations are not directly manageable, but the cause of the procedural violation can be managed. The goal is to identify any incentives that created the informal norm or accepted way of doing things. That is, what makes people act or not act?
Example Not clear - The surgical team didnt follow the correct site procedure. Clear - Due to the absence of practise compliance monitoring, a culture of non - compliance had developed and routine final checking was bypassed, which contributed to the skin lesion being removed from the wrong limb.

Rule 5
Failure to act is only causal when there is a pre-existing duty to act. The duty to act may arise from standards and guidelines for practice or other duties statements. The failure to act is judged on the duty to act at the time the incident occurred.
Example If a clinician fails to escalate certain changes in a patients condition, then this can only be causal to what happened to the patient, if there was an explicit practice standard to escalate in the first place.

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Actions and Outcomes Measures

Actions/recommendations
Actions are developed to prevent or minimise future adverse events or near misses. Actions are developed from the Root Cause Analysis Team asking: 1. How can we decrease the chance of the event from occurring again? 2. How can we decrease the degree of harm if the event were to occur again? 3. When considering changing procedures or rules, ask: What is best practice? 4. How can devices, software, work processes, or workspace be redesigned using a human factors approach? 5. How can we reduce reliance on memory and vigilance by improving processes in the workplace? 6. Actions should consider eliminating, controlling or accepting conditions. 7. Is the proposed action achievable within the limitations of the organisations resources?

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Actions and Outcomes Measures

Stronger actions Eliminate (Highest Effect)
Architectural/physical plant changes New device with usability testing before purchase Engineering control or interlock (forcing functions) Simplify the process and remove unnecessary steps  Standardise equipment and processes  Tangible involvement and action by leadership in support of patient safety Intermediate actions Control (Intermediate Effect)  Increase in staffing/decrease in workload  Software enhancement/modifications  Eliminate/reduce distractions (sterile medical environment)  Checklist/cognitive aid/clinical pathway  Eliminate look and sound alikes  Read back  Enhanced documentation/communication    

Weaker actions Accept (Lowest Effect)

    Double checks Warnings and labels New procedure/memorandum/policy Training and/or additional study/analysis.

The successful implementation of actions will be increased if they are specific and clear. The cold reader should understand what to do next. Example Not clear - Provide training. Clear - Develop and implement a training module on asthma management for all emergency staff by dd/ mm/yy.
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Actions and Outcomes Measures

Actions and Outcomes Measures

Outcome Measures
Outcome Measures are designed to demonstrate whether or not the actions/recommendations have been implemented. They can be used to measure whether recommendations have been effective. This is best demonstrated over time if they are specific and quantifiable. Use numerators, denominators, thresholds and timeframes whenever possible. Outcome measures should target what you want to address if you have a 100% compliance target for your measure, the vulnerability should be mitigated. Set realistic thresholds. Consider the need to measure the effectiveness of your action. That is, the difference it made in reducing patient harm, not just the completion or implementation of the actions.
Example Not clear - decreased injuries. Clear - Monthly monitoring of patient and staff injuries related to each episode of seclusion and restraint. Numerator = Number of patient injuries and number of staff injuries. Denominator = total number of seclusion and restraint episodes.

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RCA triage questions

Were issues related to patient assessments a factor in this situation? If yes, go to the Human Factors - Communication Factors questions. Were issues relating to staff training or staff competency a factor in this event? If yes, go to the Human Factors Training questions. Was equipment involved in this event in any way? If yes, go to the Environment/Equipment questions and Human Factors Training questions. Was a lack in information or misinterpretation a factor in this event? If yes, go to the Human Factors - Communication Factors questions. Was communication a factor in this event? If yes, go to the Human Factors - Communication Factors questions. Were appropriate rules/policies/procedures or the lack thereof a factor in this event? If yes, go to the Rules/Policies/Procedures questions. Was the failure of a barrier designed to protect the patient, staff, equipment, or environment a factor in this event? If yes, go to Barriers and respond to those items. Were personnel or personal issues a factor in this event?
RCA triage questions

If yes, go to the Human Factors Communications, Training and Fatigue / Scheduling questions.

Keep coming back to these questions until you are satisfied you have answered all of your questions!
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Human Factors Communication (HF-C)

1. Was the patient correctly identified? 2. Was information from various patient assessments shared and used by members of the treatment team on a timely basis? 3. Did the existing documentation provide a clear picture of the work-up, the treatment plan and the patients response to treatment? (These could include: assessments, consultations, orders, treatment teams notes, progress notes, medication charts, x-ray reports, laboratory reports etc). 4. Was communication between management/ supervisors and frontline staff adequate? (Was it: accurate, complete, using standard vocabulary and not jargon, and unambiguous?) 5. Was communication between team members adequate? 6. Were policies and procedures communicated adequately? 7. Was the correct technical information adequately communicated to the team who needed it 24 hours a day? 8. Were there methods for monitoring the adequacy of staff communication? (For example, read back, confirmation messages, debriefs).
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Human Factors Communication (HF-C)

9. Was communication of potential risk factors free from obstacles? 10. Was there a manufacturers recall/alert/bulletin on file for equipment, medication, or transfusion related elements at the time of the event or close call? Were relevant staff members aware of the recall/alert/ bulletin? 11. If relevant, were the patient and their family/significant others actively included in the assessment and treatment planning? 12. Did management establish adequate methods to provide information to employees who needed it in a manner that was easy to access, to use and was timely? 13. Did the overall culture of the facility encourage or welcome observation, suggestions, or early warnings from staff about risky situations and risk reduction? (Also, has this happened before and was anything done to prevent it from happening again?) 14. Did adequate communication across organisational boundaries occur?

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Human Factors Communication (HF-C)

Human Factors Training (HF-T)

1. Was there a program to identify what was actually needed for training of staff? 2. Was training provided prior to the start of the work process? 3. Were the results of training monitored over time? 4. Was training adequate? If not, consider the following factors: supervisory responsibility, procedure omission, flawed training, and flawed rules/policies/ procedures. * If yes, go the Rules/Policies/Procedures questions 5. Were training programs for staff designed up-front with the intent of helping staff perform their tasks without errors? 6. Had procedures and equipment been reviewed to ensure that there was a good match between people and the task they did; or people and the equipment they used (for example, human factors engineering)? * If procedures were not followed as intended, go the Rules/Policies/Procedures questions

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Human Factors Training (HF-T)

8. If equipment was involved, did it meet a. staff needs and experience b. existing procedures, requirements and workload c. physical space and location
*If equipment was involved, see the Environment / Equipment questions.

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Human Factors Training (HF-T)

7. Were all staff trained in the use of relevant barriers and controls? *If yes, see Barriers questions.

Human Factors Fatigue / Scheduling (HF-F)

1. Were the levels of vibration, noise, or other environmental conditions appropriate?

2. If applicable, were environmental stressors properly anticipated? *If stressors were anticipated, see the Human Factors - Training questions. *If stressors were not anticipated, why not?

3. Did the personnel have adequate sleep?

4. Did scheduling allow personnel adequate sleep?

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Human Factors Fatigue / Scheduling (HF-F)

5. Was fatigue anticipated?

6. Was the environment free from distractions?

8. Was the level of automation appropriate (either too much or not enough)? * If yes see the Environment/ Equipment questions.

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Human Factors Fatigue / Scheduling (HF-F)

7. Were sufficient staff on hand for the workload at the time? (For example, workload too high, too low, or wrong mix of staff)

Environment / Equipment

1. Was the work area /environment designed to support the function it was being used for? 2. Had there been an environmental risk assessment (for example, safety audit) of the area? *If no, consider reviewing the Rules/ Policies/ Procedures and Barriers questions. 3. Were the work environment stress levels (either physical or psychological) appropriate? * If yes, go to the Human Factors - Fatigue / Scheduling questions. 4. Had appropriate safety evaluations and disaster drills been conducted? 5. Did the work area/environment meet current codes, specifications, and regulations? 6. Was equipment designed to properly accomplish its intended purpose? 7. Did the equipment meet current codes, specifications, and regulations? 8. Was there a documented safety review performed on the equipment involved? *If relevant, were recommendations for service/recall/ maintenance etc, completed in a timely manner.

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Environment / Equipment

9. Was there a maintenance program in place to maintain the equipment involved? *If no, go to Rules/Policies/Procedures questions. 10. If there was a maintenance program, did the most recent previous inspections indicate that the equipment was working properly? 11. If previous inspections pointed to equipment problems, what corrective actions were implemented and were they effective? 12. Were adequate time and resources allowed for physical plant and equipment upgrades, if problems were identified? 13. Was there adequate equipment to perform the work processes? 14. Were emergency provisions and back-up systems available in case of equipment failure? 15. Has this type of equipment worked correctly and been used appropriately in the past? 16. Was the equipment designed such that usage mistakes would be unlikely to happen?

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Environment / Equipment

Environment / Equipment

17. Was the design specifications adhered to? *If no, go to Human Factors - Training questions. 18. Was the equipment produced to specifications and operated in a manner that the design was intended to satisfy? 19. Were the personnel trained appropriately to operate the equipment involved in the adverse event or close call? *If no, see the Human Factors - Training questions. 20. Did the design of the equipment enable detection of problems and make them obvious to the operator in a timely fashion? 21. Was the equipment designed so that corrective actions could be accomplished? 22. Were equipment displays and controls working properly and interpreted correctly? 23. Was the medical equipment or device intended to be re-used (for example, not single use device)?

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Rules / Policies / Procedures

1. Was there an overall management plan for addressing risk and assigning responsibility for risk? 2. Did management have an audit or quality control system to inform them how key processes related to adverse events functioned? 3. Had a previous audit been done for a similar event, were the causes identified, and were effective interventions developed and implemented on a timely basis? 4. Would this problem have gone unidentified or uncorrected after an audit/review? 5. Was the required care for the patient within the scope of the facilitys service capability; including staff expertise and availability, technical and support service resources?
Rules / Policies / Procedures

6. Were the staff involved in the adverse event or close call, properly qualified and trained to perform their functions? 7. Were all involved staff orientated to the job, facility, and unit policies regarding: safety, security, hazardous material management, emergency preparedness, personal protection, medical equipment, and utilities management?
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Rules / Policies / Procedures

8. Were there written up-to-date policies and procedures that addressed the work processes related to the adverse event or close call? 9. Were these policies/procedures consistent with relevant Federal and Queensland Health policies, standards, and regulations? 10. Were relevant policies/procedures clear, understandable, and readily available to all staff? * If no, go to the Human Factors - Communication questions. 11. Were relevant policies and procedures actually adhered to on a day to day basis? 12. If the policies and procedures were not used, what got in the way of their usefulness to staff? 13. If the policies and procedures were not used, what positive and negative incentives were absent?

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Barriers

1. What barriers and controls were involved in this adverse event or close call? 2. Were these barriers designed to protect patients, staff, equipment or environment? 3. Was patient risk considered when designing these barriers and controls? 4. Were these barriers and controls in place before the event happened? 5. Had these barriers and controls been evaluated for reliability? 6. Were there other barriers and controls for work processes? 7. Was the concept of fault tolerance applied in the system design?

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Barriers

Barriers

8. Were relevant barriers and controls maintained and checked on a routine basis by designated staff? *If no, go to the Rules/Policies/Procedures questions. 9. Would the adverse event have been prevented if the existing barriers and controls had functioned correctly? 10. Were the systems or processes tested before they were implemented? 11. Did the audits/reviews related to barriers include evaluations of plans, designs, installation, maintenance and process changes? *If yes, go to the Rules/Policies/Procedures questions. 12. Did management have a method for identifying what the results of the system changes would be before implementation? *If yes, go to the Rules/Policies/Procedures questions.

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More information on clinical incident management can be found in the Queensland Health Clinical Incident Management Implementation Standard (2008) at: http://www.health.qld.gov.au/patientsafety/documents/cimist. pdf

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