Whatever flavor of technician or service engineer you are, knowing how to conduct a Root Cause Analysis can improve patient safety and build your reputation with key customers. Biomedical technicians, imaging service engineers, sterilizer technicians, and so on can use a simplified version of RCA (Root Cause Analysis) to reduce preventable damage caused by end-users repeating the same mistakes, evaluate safety risks with medical device systems after an incident or near miss, and even analyze risks before a problem occurs.
Rules to Root Cause Analysis
1. Leave Bias at the Door
When I speak to technicians and service engineers privately, most undoubtedly talk about those darn nurses. Clinical staff are often blamed for the repairs, the problems with the equipment that no one can duplicate, and even those events that harm or come close to harming a patient. The second most frequent bias that we lean on is that the equipment could never be the problem.
Leave biases at the door. Root Cause Analyses need an almost scientific approach to ensure that patient safety comes first.
2. Collaborate with Stakeholders
Whether the HTM department invites the team or some other hospital safety steward, biomed technicians may be the most qualified personnel in hospitals to recognize all the stakeholders. Technicians or service engineers travel amongst several key circles within health care including clinical and medical staff, health care information technology, facilities engineering, support services, purchasing, etcetera.
Make sure the team to review near misses and incidents includes those who know the environment, the end-user and the equipment. Work with the team to leave bias at the door.
3. Investigate the Three Es
The lead should ideally decide how questions will be developed and how information will be collected; however, the group should be asked what questions need to be asked. For instance, a nursing manager may suggest that the training records for the doctor should be reviewed while the biomedical technician may recommend an independent audit when reviewing an incident with an ophthalmology laser.
Environment: Ask relevant questions about the conditions that existed during the time the event took place. Is the environment designed for the services prescribed and provided? Is the environment free of distractions or interruptions? Were there conditions that do not normally exist in the same environment such as network outages, facilities maintenance, code blues down the hall?
End-User: Examine the actions taken by the end-user during the event. Make sure the end-user is aware that a review is first and foremost an opportunity to ensure patient safety. Was training and education consistent and sufficient? When and was the end-user aware of the issue that affected patient safety? Were there physical limitations such as fatigue, stress, hearing, visual, and so on that contributed to the event?
Equipment: Evaluate the full operation and effectiveness of the equipment and any integration points. Your first step should be to determine whether the FDA must be contacted under the Safe Medical Devices Act. As a second step, determine whether the equipment should be reviewed by a non-biased party (i.e. if the OEM performs the service, maybe you should use another provider to evaluate the event). The equipment in the room and in use should be considered in your investigation. Question whether the equipment has been maintained according to your organization’s strategies. Question the qualifications of the service provider and the certificates of calibration of the test equipment used at the last routine service. Review the FDA and any other recall/hazard information sources that the organization has access to for problems which may have been previously identified. Review with the manufacturer whether the equipment operated as designed and approved in your country.
4. Review Findings and Add New Questions
Root Cause Analysis is not a linear process in most cases. Investigators may find that other stakeholders or subject matter experts need to be included. Questions may arise that need to be answered or initial findings are too cursory to identify a root cause or causes.
5. Recommend Actions for Success
Root Cause Analysis should result in documented recommendations which, in the case of health care, result in improved safety, more available equipment, better patient outcomes, or better business operations.
Recommendations set a goal or goals to one or all of these ends. The goal should be SMART (Specific, Measurable, Achievable, Reasonable, and Timely).
6. Measure Your Organization’s Success
There are two key reasons why you should review whether the Root Cause Analysis and pursuant recommendations were a success. If you set clear goals with measurable outcomes, this step may result in additional measures or professional satisfaction of a RCA done well.
The first reason one should measure success is to improve health care outcomes and business.
The second reason that one would measure success is to identify areas where your next analysis may benefit. We can learn from our mistakes.
In summary, a Root Cause Analysis is an approachable tool that all HTM professionals should use. An RCA may be used before an event or incident occurs to identify a potential issue before it happens. An RCA, of course, can be used whenever an event or a near miss occurs to identify the causes and take action to prevent a similar occurrence.
Dustin Telford, CBET, CRES, CLES, CHTM, is a Field Service Manager with HSS assigned to Children’s Hospital Colorado and serves as the hospital’s Biomedical Equipment Manager. He is also Director of Clinical Engineering for earthMed.