Nurse with tuberculosis potentially exposed over 1,000 –  including 350 infants

By Kim Smiley

A nurse recently diagnosed with active tuberculosis may have potentially exposed over 1,000 people. The nurse worked in the area near the newborn nursery so the potentially exposed individuals include 350 infants.  No additional tuberculosis cases have been reported at this time, but hospital officials are working to test all potentially exposed individuals and are offering preventative treatment to the exposed infants because they are at higher risk of dangerous complications from the disease.

This issue can be analyzed by building a Cause Map, a visual format for performing a root cause analysis.  Cause Mapping allows the causes that contribute to an issue to be better understood,  which can aid in the development of effective solutions.  The first step in Cause Mapping is to fill in an outline to capture the basic background information (who, what, when and where) for a problem.  Additionally, the outline has space on the bottom to list how the problem impacted the goals.   The second step in the process is to determine how the problem occurred by building the actual Cause Map by starting at one of the impacted goals and asking “why” questions to lay out all the causes that contributed to an issue.  The idea is to identify ALL the causes and not just one single “root cause” so that many different solutions are considered, not just the ones that impact a single cause.

So how did a nurse unintentionally expose 1,000 people to tuberculosis?  The nurse was unaware that she had tuberculosis.  She did not exhibit many of the common symptoms such as coughing and the disease was only identified after a chest x-ray that was done for an unrelated medical concern.  Additionally, she tested negative for tuberculosis in September during an annual checkup so there was no reason to believe that she was at risk of spreading tuberculosis.

No specific information has been released about why the nurse in this particular example tested negative for tuberculosis at the time of her screening, but there are a number of factors that can affect the accuracy of testing.  If the tuberculosis infection is recent (within 8-10 weeks) the test may not catch it; recent live-virus vaccination can affect results as can some viral illnesses.  And of course, incorrect test administration or misinterpretation of the results could also cause a false negative test result.

The final step in the Cause Mapping process is to develop solutions that address the specific problem at hand and hopefully prevent a reoccurrence of the issue.  The nurse has been put on leave until the risk of spreading the illness has passed to prevent more people from being exposed.  The risk of infection from this particular individual is believed to be low because she wasn’t coughing, which can spread the illness, but hospital officials are identifying and testing all potentially exposed individuals.  Additionally, the 350 potentially exposed infants are being offered treatment to prevent tuberculosis because the health risks to them are more severe than older children and adults (tuberculosis can enter the bloodstream and infect other organs).

The good news about this case is that no additional cases of tuberculosis have been found and the overall risk of the infection spreading is believed to be low because of the mild symptoms experienced by the nurse.  The bad news is that it will continue to be difficult to identify a case of tuberculosis if the individual involved has mild or no obvious symptoms and gets a false negative on a tuberculosis test.

A similar case occurred in Texas in 2014, where another healthcare worker who worked around infants was found to have active tuberculosis.  Click here to see that example.

Healthy kidney removed by mistake

By Kim Smiley

The Patient Safety Network presented a case study where a patient with suspected kidney cancer had the wrong kidney removed.  Instead of the right kidney that showed suspected renal cell carcinoma in a CT scan, the healthy left kidney was removed. A second surgery was then performed to remove the right kidney and the patient was left dependent on dialysis after losing both kidneys.  The patient wasn’t a candidate for a kidney transplant because of the cancer.

Reviewing and understanding case studies such as this one is important because wrong-site surgeries are one of the more common serious medical errors.  A Cause Map, a visual root cause analysis, can be used to better understand the many causes that contributed to this wrong-site surgery, and better understanding the causes of an incident leads to development of better solutions.  The first step in building a Cause Map is to fill in an Outline with the basic background information.  These details are often not published for medical errors to protect patient privacy, but the information should be recorded if available.  The bottom of the Outline also includes space to list how the issue impacts the overall organizational goals. The Cause Map itself is built by starting at one of the impacted goals and asking “why” questions.

Focusing on the patient safety goal as a starting point, the investigation could be started by asking “why was a healthy left kidney removed instead of the right?” The surgeon who performed the surgery believed the tumor was in the left kidney because all patient information readily available stated the tumor was in the left kidney.  The case study didn’t include details on how this error in the patient’s record occurred, but it is known that a CT scan was initially performed at a different hospital than the one that performed the surgery.  The patient sought treatment at the first hospital after suffering from abdominal pain and hematuria and a CT scan was performed.  He was transferred to a second hospital for the surgery after the CT scan revealed suspected renal cell carcinoma.  An image of the CT scan was not included with the patient records at the time of transfer and the records noted that there was a tumor in the incorrect (left) kidney.

The stage was essentially set for a wrong-site surgery and the surgeon missed the opportunity to prevent it.  The surgeon chose to perform the surgery based on the records without either verifying the original CT (because it was not available) or requesting an additional CT scan to be performed to confirm the diagnosis.  It does not appear that the surgeon was required to review the CT scan, but the decision on whether to do so was left up to the surgeon’s judgement. The error was only identified after the pathologist who examined the left kidney found no evidence of cancer and informed the surgeon who then reviewed the original CT scan and realized the wrong kidney had been removed.

Once the causes that contributed to an issue have been identified, the final step in the Cause Mapping process is to identify and implement solutions to prevent a problem from reoccurring.  One way to prevent similar errors is to require labeled radiology images to be available to the surgeon prior to any surgery.  Requiring a review of images prior to the surgery would build in a double check to ensure the surgery is performed at the correct site.  Building in a double check of medical records may also reduce errors like the wrong kidney being listed as potentially cancerous or a patient being transferred with medical files missing important radiology images.

FDA’s Wish List: Regulatory Authority for Lab-Developed Tests

By ThinkReliability Staff

Laboratory testing is incredibly important to health care – it is thought to be an influence in about 70% of health decisions. Results of testing will often be used to diagnose a patient, or select a treatment plan. Thus, inaccurate testing results can lead to inappropriate, sometimes even dangerous, treatments. However, diagnostic tests manufactured and used within a single laboratory, known as laboratory developed tests, or LDTs, are not subject to regulation by the FDA.

This has led to significant concern by the FDA, outlined in a report making the case for FDA oversight for these tests. Their concerns can be diagrammed in a Cause Map, or visual root cause analysis, allowing us to see how the specific concerns are related and impact patient safety and other regulatory goals.

The first step in any problem solving method is to determine the problem that is to be solved. Using the Cause Mapping method, the “problem” is defined as an impact to an organization’s goals. In this case, patient safety is impacted because of the possibility for insufficient treatment of life-threatening disease and the potential for patients to undergo unnecessary dangerous procedures. Additionally, patient services are impacted because of the threat to the scientific integrity of clinical trials using these tests.

The second step in the Cause Mapping method is the analysis. Beginning with one of the impacted goals and asking ‘why’ questions develops the cause-and-effect relationships involved in the issue. In this case, we begin with the patient safety goal that is impacted due to insufficient treatment for life-threatening disease. This is due to either a failure to detect the disease and/or to patients choosing to undergo unproven therapies. We address each cause in turn.

The failure to detect a disease is caused by inaccurate test results and/or insufficient interpretation of test results. Inaccurate test results can be caused by tests not being clinically valid (one of the FDA’s prime concerns) because the test is not regulated by the FDA. The test is not required to be regulated by the FDA, which is the addressed in the FDA’s report. The argument against requiring FDA regulation for tests is that the laboratories that create and use the tests are regulated under the Clinical Laboratory Improvement Amendments (CLIA). However, according to the FDA, CLIA is intended to regulate the operators of laboratories, not diagnostic devices. The report provides multiple case studies of problematic LDTs, which were offered from laboratories “following the minimum requirements of CLIA.”

Inaccurate test results are also caused by not identifying adverse events, which are not systematically reported for these tests (another of the FDA’s prime concerns). An additional prime concern of the FDA is that performance data is not required to be reviewed prior to marketing these devices. Not only is FDA approval not required, but there is an incentive for companies not to seek FDA approval of LDTs, leading to an uneven playing field (another of the FDA’s prime concerns) for companies who do seek FDA approval of laboratory tests. Insufficient interpretation of test results occurs because testing labels do not provide adequate information on interpretation (another of the FDA’s prime concerns).   Again, these causes are due to not requiring regulation by the FDA.

The FDA is concerned that results from unapproved testing may result in patients choosing to undergo unproven therapies. Misleading manufacturer’s claims and/or lack of transparency can mean patients are unaware that the tests have not been cleared or approved by the FDA. These causes are both listed as prime concerns of the FDA. Patients are unable to assess tests available because there is no comprehensive listing of tests currently being used (the last prime concern of the FDA).

Because of these reasons (causes), the FDA is requesting oversight of LDTs. The oversight provided by the FDA would ideally provide solutions to these issues by addressing each of the concerns (causes) listed in the report. To learn more, click here to read the report. Or, click on “Download PDF” above to view the cause-and-effect relationships including the FDA’s concerns about LDTs.