Root Cause Analysis Flashcards
Incident = > Analysis
● What happened?
● Why did it happen?
● What can be changed to eliminate (preferable) or decrease the likelihood of a
repeated incident (more likely result)
● Alberta College of Pharmacy - Standards for the Operation of Licensed
Pharmacies (Std 6)
○ A licensee must implement a quality assurance program to monitor and improve processes to
minimize risk.
● Alberta College of Pharmacy - Standards of Practice for Pharmacists and Pharmacy Technicians (Std 1.10) - participate / (Std 1.11) - implement
● Did someone do something intentionally?
● Intentional / deliberate acts needed to be reviewed differently than a systems
based review
○ Performance management process?
○ Disciplinary process?
○ Criminal process?
● Known deficiency in knowledge / skill of practitioner(s) involved
○ Performance management process?
Management of the incident is the priority!
● Did someone do something intentionally?
● Intentional / deliberate acts needed to be reviewed differently than a systems
based review
○ Performance management process?
○ Disciplinary process?
○ Criminal process?
● Known deficiency in knowledge / skill of practitioner(s) involved
○ Performance management process?
Management of the incident is the priority!
- Gather information (What happened?)
- Analyse the information information (Why did it happen?)
- Identify root and contributing causes (Why did it happen?)
- Action plan for change (How can we prevent it from happening again?)
Types of Analysis (3)
● Concise ○ Fastest ○ 1-2 reviewers ○ Low to moderate risk of harm to patients / staff / property ● Comprehensive ○ Significant time requirement ○ Large committee of reviewers ○ Major harm ● Multi-Incident ○ Group several incidents together ○ Usually low to moderate harm ○ Can group concise or comprehensive analysis
Team Based Approach
● Meetings / deliberations should be kept confidential
○ This is about the “system” not about the “individual”
● Best practice - confidentiality agreement
● Can a patient representative be included?
Initial Understanding - “What Happened”
● Typically found from the “Drug Incident Report Form” or similar reporting
documentation
○ Document the known facts
● Obtain additional information to enhance understanding
○ A “walk through” of the incident
○ Patient records / prescriptions / labels / etc.
○ Review of current policies and procedures
○ Review of existing practices
○ Review of safety reports / potential solutions
■ ISMP Canada Safety Bulletins / Global Patient Safety Alerts
■ Literature review
○ Interviews with individuals involved
○ Patient outcomes (what happened to the patient as a result of the incident?)
Final Understanding - “What Happened”
● Create a detailed timeline of the incident
○ Include time (estimated if needed), what occurred (actual), source of the information
Analyze / Identify Root and Contributing Causes
Why did it happen? What caused it to happen?
● Focus is not on the individual(s)
● Focus is on the “system”
● Recommended use of visualization techniques to work through the system of
events (e.g. a tree diagram)
● Team to determine a “starting point” and work backwards from that point
○ Eg) Wrong medication released to the patient
Outcome Patient inconvenienced. Pharmacy delivered correct prescription medication. (Pharmacy reputation damaged)
Causal Chains
● Ask “Why?”
● Ask “What caused it?”
● Contributing Factors = > Root Cause
○ Action (a short lived event)
■ Interrupted by a customer when checking the prescription
○ Condition (something that exists over a longer period of time)
■ Only staff member in the dispensary
contributing factors - ineffective final check
Incorrect product
selected in Kroll
- Unfamiliar with pharmacy software
- Drug names very similar and for same indication
- Inadequate training / orientation to practice site
- Check did not compare label to original Rx
- Patient not shown completed prescription before release
Root Cause
● A root cause will usually help identify something that the pharmacy (or health
team) can do to prevent the same thing from happening again
● Next step is to create a causal statement (problem statement)
Causal Statement Format
● A - Antecedent
● B - Bridging
● C - Consequences
Causal Statement
Inadequate training / orientation to the practice site increased the likelihood that a
pharmacist, being unfamiliar with the dispensary system, would select the wrong
medication to generate a label, leading to a patient receiving the wrong
medication.
Changes - The Action Plan
● What can be changed to eliminate (preferable) or decrease the likelihood of a
repeated incident (more likely result)
● Use causal statements to create action items for implementation
● Team to develop recommendations (agreed upon)
○ Seek solutions according to the “hierarchy of effectiveness”
■ ISMP Canada
■ Patient Safety Institute of Canada
■ Health literature
■ Regulatory bodies
■ Networking
Effectiveness
High Leverage - Most Effective
● Engineering / computer assisted
● System constraints
○ Ex.) Requiring a pharmacist to enter initials / password / explanation on rationale for action
before the computer system will allow dispensing of a medication where a serious drug
interaction was identified
● Automation
○ Ex.) Implementing robotic dispensing equipment to fill prescriptions
Effectiveness
Medium Leverage - Lower Level of Effectiveness
● Standardization
○ Ex.) Use of a checklist that must be completed through the dispensing process
slow down the checking process
● Independent Double checks
○ Ex.) Having another person check a prescription that was filled by someone else (another set
of eyes)
● Reminders
○ Ex.) A pop-up reminder to advise a pharmacist that they need to review a patient’s lab value
(e.g. INR) and assess the patient’s next dose
Effectiveness
Low Leverage - Lowest Level of Effectiveness
● Policies and Procedures
○ Ex.) Written standard operating procedures that staff are to follow when compounding a
medication
● Training
○ Ex.) Having a new employee learn from another employee
● Communication
○ Ex.) Using a communication binder for pharmacists to communicate issues that were not
completely addressed before the end of their shift
