“Root Cause Analysis to Address Health Concerns” by Kelly Rodkey

My daughter recently developed a skin condition that the pediatrician could not identify.  In her frustration, she declared, “Well I want to get a definitive diagnosis, not spend a year chasing around and guessing what it is!”

It reminded me that root cause analysis can be used to diagnose a medical condition.  Routine monitoring of human clinical chemistry can find an “out-of-specification” value in need of investigation.

As an example, Lee routinely got annual physicals.  Health insurance companies encouraged it and she thought it was a valuable investment as she realized she was no longer an invincible twenty-something.  At the office exam everything looked great, healthy weight and no major complaints.  She thought the insomnia, fatigue, joint pain, and trouble with concentration, were just a result of age and the hectic schedule of a working mother of three.  However, the routine lab work showed that Lee’s iron levels were quite low even though she took iron supplements since the birth of her then 10-year-old son.

It took multiple blood tests, fluid samples, and an upper and lower endoscopy to finally diagnose the root cause of the low iron level.  However, once clinicians identified the autoimmune disease, a  solution could be implemented… effectiveness is to be determined.

It would be nice if medical diagnoses could be swift and accurate, but as is often the case in industry, if the needed data are not available to identify the cause, then a well-planned investigation to collect more data must begin.

How will you manage your own health?  An annual physical allows the physician to monitor routine clinical chemistry values and to identify when something is trending out of specification.  Once the out of specification condition is identified, the investigation can begin.  With luck, the root cause can be quickly diagnosed, solutions can be identified and implemented, and the effectiveness of the solution can be evaluated… all with facts and data and not prolonged physician guessing.

Kelly Rodkey spent over 22 years in the healthcare industry at Abbott and Baxter in many quality roles, which encompassed testing and manufacturing, new product development, and clinical study report submissions.  In her most recent role as a CAPA Quality Approver, Kelly worked with investigation teams to ensure nonconformances were fully investigated, corrective and /or preventive actions were effective, and documentation narratives were understandable and fully supported.  She holds three ASQ certifications and has been a member of ASQ Section 1212 since 2009.

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