Abstract
Background Parents of many children with cancer administer highly complex chemotherapy regimens at home which are error prone. One way to identify and repair potential error prone processes is with a Failure Mode and Effect Analysis (FMEA). An FMEA is a systematic, team-based approach to understanding the ways a process can fail and developing interventions; it has been used in hospitals for decades but has never, to our knowledge, been used with a team of parents.
Methods The objective of this study was to identify aspects of the home medication use processes at risk for error and propose interventions using an FMEA with a group of parents. We recruited parents of children with cancer taking home medications. FMEA steps included: selection of a high-risk process; diagram the process; brainstorm potential failure modes; rate and prioritize failure modes; identify root causes; and redesign the process. The target high-risk process was parent/ caregiver administration of 6-mercaptopurine following a change in medication dose. Parents were trained in FMEA methodology using materials at a 6th grade reading level and a real-life example. Failure modes were prioritized using ratings for severity, frequency of occurrence, and detectability.
Results The process diagram developed by the parent-team included 12 steps. The highest priority failure modes were:
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shared instructions by the parent who attended the clinic visit regarding change in dose are misunderstood by the other caregiver(s);
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administration of chemotherapy without realizing that another caregiver already administered it;
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parent misunderstanding of physician’s instructions about the change in dose; and
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the parent who attended the clinic visit shares incorrect instructions regarding the change in dose with other caregivers.
During the discussion of interventions, communication tools (e.g. written instructions from the physician, a home medication calendar with communication tools such as check boxes to indicate when a dose had been administered, and others) were high priority for parent participants.
Conclusions Parents can understand and perform an FMEA. The parent-team identified modifiable failure modes, many communication-related, which could lead to significant patient injury in home medication use. Parents prioritized tools that could lead to system improvements and reduce errors.




