Systematic list of questions to ask during RCA investigation

Return to these questions often.

1. Were issues related to patient assessment a factor in this event?
   If yes, go to the human factors communication questions.
2. Were issues related to staff training or staff competency a factor in this event?
   If yes, go to the human factors knowledge/skills/competence questions.
3. Was equipment (or the use or lack of use of equipment) involved in this event in any way?
   If yes, go to the environment / equipment and human factors knowledge/skills/competence questions.
4. Was a lack of information (or misinterpretation of information) a factor in this event?
   If yes, go to the human factors communication questions.
5. Was communication a factor in this event?
   If yes, go to the human factors communication questions.
6. Were appropriate policies/procedures or guidelines — or lack thereof — a factor in this event?
   If yes, go to policies and procedures.
7. Was the failure of a safety mechanism or a barrier, designed to protect the patient, staff, equipment, or environment a factor in this event?
   If yes, go to the safety mechanism questions.
8. Were specific patient issues a factor in this event?
   If yes, go to the patient factors questions.

Communication (human factors)

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?
   If {No}, this could be a Root Cause/Contributing Factor.
   Use the RCA statement rules to organize your thoughts about this.
3. Did existing documentation provide a clear picture of the work-up, the treatment plan and the patient's response to treatment? These could include:
   • assessments
   • consultations
   • orders
   • treatment team notes
   • progress notes
   • medication administration records/charts
   • x-ray reports
   • — etc. —
   If {No}, this could be a Root Cause/Contributing Factor.
   Use the RCA statement rules to organize your thoughts about this.
4. Was communication between management/supervisors and front line staff adequate? Was it:
   • accurate
   • complete
   • using standard vocabulary and not jargon
   • unambiguous
   If {No}, describe how management/supervisors and front line communications are not adequate.
5. Was communication between front line team members adequate?
   If {No}, describe how communications between team members were deficient and identify where they could be improved.
6. Were policies and procedures communicated adequately?
   If {No}, describe how policies and procedures were not communicated adequately.
   If this is an issue, see the policies and procedures questions.
7. Was the correct technical information adequately communicated to the people who needed it 24 hours a day?
   If {No}, describe how communication about technical information is not adequate.
8. Were there methods for monitoring adequacy of staff communication?
   Were there methods for:
   • 'read back'
   • confirmation messages
   • debriefs
   • — etc.
   If {No}, this could be a Root Cause/Contributing Factor.
9. Was the communication of potential risk factors provided to the people who needed to know?
   If {No}, this could be a Root Cause/Contributing Factor.
   Use the RCA statement rules to organize your thoughts about this.
10. Was there manufacturer's 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?
    If this is an issue, consider environment and equipment questions.
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/use, and timely?
    If {No}, this could be a Root Cause/Contributing Factor.
    Use the RCA statement rules to organize your thoughts about this.
13. Did the overall culture of the facility encourage or welcome observations, 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?

Human Factors: Knowledge/Skills/Competence (Training)

1. Was there a program to identify what is 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 the training adequate?
   (If not, consider the following factors: supervisory responsibility, procedure omission, flawed training, flawed guidelines, policy, or procedure)
   If yes, go to the policies and procedures.
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 tasks they did; or people and the equipment they used (i.e. human factors engineering)?
   If no, see the policies and procedures.
7. Were all staff trained in the use of relevant safety mechanisms and controls?
   If no, see the safety mechanism questions.
8. If equipment was involved, did it work smoothly in the context of: staff needs and experience, existing procedures, requirements, workload and physical space and location?
   If no, see the equipment questions.

Work Environment/Fatigue/Scheduling

1. Was the work area/environment designed to support the function it was being used for?
2. Had there been an environmental risk assessment (re safety audit) of the area?
   If no, consider reviewing the rules / policies and procedures questions and the barrier questions.
3. Were the work environment stress levels (either physical or psychological) appropriate, e.g. temperature, space, noise, intra-facility transfers, construction projects?
4. Had appropriate safety evaluations and disaster drills been conducted?
5. Did the work area/environment meet current codes, specifications, and regulations?
6. Were the levels of vibration, noise, or other environmental conditions appropriate?
7. If applicable, were environmental stressors properly anticipated?
   If stressors were anticipated, see the human factors knowledge/skills/competence questions.
   If stressors were not anticipated, why weren't they anticipated?
8. Did personnel have adequate sleep?
9. Did scheduling allow personnel adequate sleep?
10. Was fatigue properly anticipated?
11. Was the environment free of distractions?
12. Were there sufficient staff on hand for the workload at the time (i.e. workload is too high, too low, or wrong mix of staff)?
    If yes, see the human factors knowledge/skills/competence questions.
13. Was the level of automation appropriate (i.e. neither too much nor not enough)?

Equipment

1. Was equipment designed to properly accomplish its intended purpose?
2. Did the equipment involved meet current codes, specifications, and regulations?
3. 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?
4. Was there a maintenance program in place to maintain the equipment involved?
   If no, go to policies, procedures and guidelines.
5. If there was a maintenance program, did the most recent previous inspections indicate that the equipment was working properly?
6. If previous inspections pointed to equipment problems, what corrective actions were implemented and were they effective?
7. Were adequate time and resources allowed for physical plant and equipment upgrades, if problems were identified?
8. Was there adequate equipment to perform the work processes?
9. Were emergency provisions and back-up systems available in case of equipment failure?
10. Had this type of equipment worked correctly and been used appropriately in the past?
11. Was the equipment designed such that usage mistakes would be unlikely to happen?
12. Was the design specification adhered to?
    If yes, go to the human factors knowledge/skills/competence questions.
13. Was the equipment produced to specifications and operated in a manner that the design was intended to satisfy?
14. Were personnel trained appropriately to operate the equipment involved in the adverse event/close call?
    If no, see the human factors knowledge/skills/competence questions.
15. Did the design of the equipment enable detection of problems and make them obvious to the operator in a timely manner?
16. Was the equipment designed so that corrective actions could be accomplished in a manner that minimised/eliminated any undesirable outcome?
17. Were equipment displays and controls working properly and interpreted correctly?
18. Was the medical equipment or device intended to be reused (eg not a Single Use Device)?

Policies/Procedures/Guidelines

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 the adverse event are functioning?
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 required care for the patient within the scope of the facility's mission, staff expertise and availability, technical and support service resources?
6. Were the staff involved in the adverse event or close call properly qualified and trained to perform their functions?
7. Had all staff involved been oriented to the job, facility and unit policies regarding: safety, security, hazardous material management, emergency preparedness, life-safety-management, medical equipment, and utilities management?
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 state policies, standards, and regulations?
10. Were relevant policies/procedures clear, understandable and readily available to all staff?
    If no, go to the human factors communications questions.
11. Were the relevant policies and procedures actually used on a day-to-day basis?
12. If the policies and procedures were not used, what prevented their use by the staff?
13. If policies and procedures were not used, what positive and negative incentives were absent?

Safety Mechanisms

1. What safety mechanisms (barriers) and controls were involved in this adverse event or close call?
2. Were these safety mechanisms designed to protect patients, staff, equipment or environment?
3. Was patient risk considered when designing these safety mechanisms and controls?
4. Were these safety mechanisms and controls in place before the event happened?
5. Had these safety mechanisms and controls been evaluated for reliability?
6. Were there other safety mechanisms and controls for work processes?
7. Was the concept of 'fault tolerance' applied in system design?
8. Were the relevant safety mechanisms and controls maintained and checked on a routine basis by designated staff?
   If no, go to the policy, procedures and guidelines questions.
9. Would the adverse event have been prevented if the existing safety mechanisms and controls had functioned correctly?
10. Were the system or processes tested before they were implemented?
11. Did the audits/reviews related to safety mechanisms include evaluation of plans, designs, installation, maintenance and process changes?
    If yes, go to the policy, procedures and guidelines 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 policy, procedures and guidelines questions.
13. Was support or supervision a factor in this case?
14. Did the staff involved feel they could discuss the case freely prior to the incident?

Patient Factors

1. Was the patient's condition, either complexity or seriousness, a factor in this case?
2. Did personal issues -- personality, language, external support or social and family circumstances contribute to this event?
3. Were there known risks associated with the treatment being provided to the patient?
4. Was there a medical, personal or emotional history that may have contributed to this event?
5. Was there a good staff/patient working relationship?
6. Were the patient/visitors helpful and cooperative?