A 29-year-old male was seen at Best Health Clinic, a family medicine clinic, for the first time by Dr. Smith in April 2009. The patient’s main problem was bronchitis, which was evaluated and treated appropriately. The patient also mentioned a new mole on his right arm and he was set up for a biopsy in May 2009. The biopsy was performed and sent to Bestpath. The biopsy report was never seen in the clinic. It was either not forwarded or received and not attached to the chart.
The patient was seen multiple times over the next few years and the pathology result was never mentioned. Finally, in February 2011, the patient presented with another mole in the same area and it was also biopsied and sent to Bestpath. This was a melanoma and triggered a search for the first biopsy. Eventually, it was discovered that the first 2009 biopsy had also shown a melanoma.
Bestpath’s explanation was that it received the biopsy in May 2009. At that time, the pathologist who examined the biopsy felt that there was unusual compound melanocyte proliferation. The pathology was forwarded to a center of excellence for a second opinion, and in June 2009, it was diagnosed as malignant melanoma. This report was sent to Bestpath in late June 2009.
Dr. Smith does not believe he is responsible as he never received the report. Best Health Clinic states that it never received the report. Upon further review, it did not appear that the clinic had a good tracking system for its lab, X-ray and pathology reports.
Bestpath stated that its standard procedure is to send the report to the physician, but it could not prove that this this particular report had been sent to the Best Health Clinic.
The patient was eventually diagnosed with stage IV melanoma. Dr. Smith and Bestpath both settled in 2012 with the patient for a large sum of money.
In Mark Graber’s landmark 2005 study[i] titled “Diagnostic Error in Internal Medicine,” there was an examination of 100 cases of diagnostic errors in the hospital setting. He identified 548 different system-related or cognitive factors (5.9 per case). System-related factors contributed to the diagnostic error in 65 percent of the cases and cognitive factors in 74 percent. The most common system-related factors involved problems with policies and procedures, inefficient processes, teamwork, and communication. His conclusion was “Diagnostic error is commonly multifactorial in origin, typically involving both system-related and cognitive factors.”
Two other studies[ii],[iii] by Hardeep Singh that focused on test follow-up found that 7 percent of significant lab abnormalities and 8 percent of significant imaging abnormalities lacked timely follow-up. The final important background information comes from a study[iv] that showed that a typical primary care provider’s office receives 852 lab, X-ray and pathology reports in a week.
In analyzing this closed claim, the above studies are informative. There are two major error types, cognitive and systems, and this would appear to be a prototypical systems error—a significant test result was not reported back to the patient. We can see from the above studies that this is something that occurs in almost 10 percent of significant results.
We know that most practices have a large number of tests to track. We also know from a practice perspective that Best Health Clinic did not have a good system to track when a test was pending and get that result to the patient. Did Dr. Smith actually ever see the test result? We will never know for sure because Best Health Clinic had no tickler file that could have alerted him that such an important test result was still pending.
Bestpath had two different issues. First, this was a difficult biopsy to interpret and was sent for a second opinion. As such, this deviated from its customary pathology process flow, and Bestpath had no system to prove that it had actually sent the report. Second, Bestpath also made no effort regarding this important test result to call or communicate with the provider in a subsequent, more urgent fashion.
For Dr. Smith, the main issue is the tracking of test completion and results. If he had been aware of the melanoma, he would have certainly referred the patient to the appropriate dermatologist and/or oncologist. This event does not represent a deficit in his knowledge. We are all responsible for tracking the many tests that we order. This could be accomplished using an “old-style” accordion folder with important pending tests and reminder notices (follow-up colonoscopies and such), or this could be done in a digital format.
Finally, from the provider’s perspective, we should consider involving the “patient” in reinforcing patient safety. Inform patients that “no news is not good news” and ask them to follow up if they haven’t heard about an important test. Document in the record that you advised the patient to follow up. Patient portals are becoming more common and will help, but even then it will still be incumbent on the provider to initiate follow-up for a significant abnormal finding.
For Bestpath, the lesson learned from this case study deals with the issue of tracking how test results are reported. The American College of Radiology has led the way in its 2010 ACR Practice Guideline for Communication of Diagnostic Imaging Findings. These guidelines state that “in emergent or other non-routine clinical situations, the interpreting physician should expedite the delivery of a diagnostic imaging report (preliminary or final) in a manner that reasonably ensures timely receipt of the findings.” Situations that may require non-routine communication include: 1) findings that suggest a need for immediate or urgent intervention; 2) findings that are discrepant with a preceding interpretation of the same examination and where failure to act may adversely affect patient health; 3) findings that the interpreting physician reasonably believes may be seriously adverse to the patient’s health and are unexpected by the treating or referring physician.
All specialists who are consultants should consider following these guidelines. If the biopsy result is significantly abnormal or there is an unexpected finding, a second form of direct communication should be used to convey the results.
In his book, Better: A Surgeon’s Notes on Performance, author Atul Gawande wrote “We always hope for the easy fix: the one simple change that will erase a problem in a stroke. But few things in life work this way. Instead, success requires making a hundred small steps go right—one after the other, no slipups, no goofs, everyone pitching in.”
[i] Arch Intern Med. 2005 Jul 11; 165(13):1493-9.
[ii] J Am Med Inform Assoc. 2010 Jan-Feb; 17(1):71-7.
[iii] Arch Intern Med. 2009 Sep 28; 169(17):1578-86.
[iv] Ann Intern Med. 2005; 142(5):352-358.
Created by MagMutual from materials provided by COPIC as part of MagMutual and COPIC’s alliance to improve patient safety and quality of care for all of our PolicyOwners.