March 6, 2012
Once your pharmacy team has a final understanding of the circumstances surrounding a drug incident, your team can then begin to answer the questions “Why did it happen?” and “What caused this?”
The triage and triggering questions included in the Systems Approach to Quality Assurance are designed to help identify contributing factors and underlying problems that may not otherwise be considered. By identifying these factors, your team will be able to come up with high leverage solutions to prevent the incident from recurring.
You can view the complete set of triage and triggering questions in the Incident Analysis Process Summary and Quick Reference Guide.
I. Human factors: Communication
Questions in this section are intended to help assess issues related to communication, flow of information and availability of information as needed.
- Was the patient correctly identified?
- Was information from various patient assessments shared and used by members of the treatment team on a timely basis?
- Did existing documentation provide a clear picture of the work-up, the treatment plan and the patient’s response to treatment? (Including, for example, assessments, consultations, orders, treatment team notes, medication administration records, lab reports.)
- Was communication between management/supervisors and front-line staff adequate?
- Was communication between front-line team members adequate?
- Were policies and procedures communicated adequately?
- Was there a manufacturer’s recall/alert/bulletin on file for medication or equipment at the time of the event or close call? Were relevant staff members aware of the recall/alert/bulletin?
- If relevant, were the patient and their family/significant others actively included in the assessment and treatment planning?
- 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?)
II. Human factors: Training
These questions relate to routine job training, special training and continuing education, including the timing of that training. These questions also focus on the interfaces between people, workspace and equipment.
- Was there a program to identify what was actually needed for training of staff?
- Were the results of training monitored over time?
- Was the training adequate? (If not, consider supervisory responsibility, procedure omission, flawed training, flawed policies or procedures.)
- Were training programs for staff designed upfront with the intent of helping staff perform their tasks without errors?
- 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., application of human factors engineering principles)?
III. Human factors: Fatigue/scheduling
Questions in this section weigh the influence of stress and fatigue that may result from scheduling and staffing issues, sleep deprivation or environmental distractions such as noise.
- Were the levels of vibration, noise or other environmental conditions appropriate?
- If applicable, were environmental stressors properly anticipated (e.g., distractions)?
- Did scheduling allow personnel adequate sleep?
- Was fatigue (e.g., due to workload or scheduling) properly anticipated?
- Was there sufficient staff with the appropriate skills on hand for the workload at the time?
- Was the level of automation appropriate for the tasks to be accomplished?
IV. Environment: Equipment
These questions are intended to help evaluate factors related to the use and location of equipment; fire protection and disaster drills; codes, specifications and regulations; the general suitability of the environment; and the possibility of recovery after an error has occurred.
- Was the work area/environment designed to support the function it was being used for?
- Did the work area/environment meet current codes, specifications and regulations?
- Was there adequate equipment to perform the work processes?
- Was there a documented safety review maintenance program performed on the equipment involved? If relevant, were recommendations for service/recall/maintenance, etc. completed in a timely manner?
- Had this type of equipment worked correctly and been used appropriately in the past?
- Were personnel trained appropriately to operate the equipment involved in the adverse event/close call?
- Were equipment displays and controls working properly and interpreted correctly?
- Was the medical equipment or device intended to be reused (e.g., not a single-use device)?
V. Rules: Policies/procedures
Questions in this section focus on the existence and ready accessibility of policies and procedures, including technical information for assessing risk, mechanisms for feedback on key processes, effective interventions developed after previous events, compliance with national and provincial regulations, and the usefulness of and incentives for compliance with codes, standards and regulations.
- Was there an overall management plan for addressing risk and assigning responsibility for risk management?
- Did management have an audit or quality control system to inform them how key processes related to the adverse event were functioning?
- 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?
- Would this problem have gone unidentified or uncorrected after an audit/review?
- Were all involved staff oriented to the job, facility and unit policies regarding safety, security, hazardous material management, emergency preparedness, and medical equipment management?
- Were there written up-to-date policies and procedures that addressed the work processes related to the adverse event or close call?
- Were these policies/procedures consistent with relevant provincial and national standards and regulations?
- Were relevant policies/procedures clear, understandable, and readily available to all staff?
- If the policies and procedures were not used, what got in the way of their usefulness to the staff?
- What barriers and controls were involved in this adverse event or close call?
- Was patient risk considered when designing these barriers and controls?
- Were the relevant barriers and controls maintained and checked routinely by designated staff?
- Would the adverse event have been prevented if the existing barriers and controls had functioned correctly?