Root Cause Analysis

More than 2,700 babies are born with microcephaly in 2015 in Brazil

By Kim Smiley

In 2014, fewer than 150 babies were born with microcephaly in Brazil, but the number dramatically increased in 2015 with more than 2,700 cases.  Microcephaly is a neurological disorder where the growth of the head is stunted with reduced brain function in 90 percent of cases.  Infants with microcephaly often have reduced life spans and require significant long-term care.  The spike in microcephaly is so alarming that some doctors and health officials are encouraging women in the regions with a high concentration of microcephaly cases to avoid becoming pregnant at this time.

Health officials are still working to understand exactly what caused the increase in microcephalic babies, but many believe Zika virus is contributing to the problem.  Zika virus is a mosquito-borne virus and the symptoms are similar to many other mosquito-borne viruses such as dengue and chikungunya.  Latin America reported their first Zika virus cases in 2014 and the spread of Zika virus matches the timing of the increase in microcephaly cases.  Additionally, many mothers of babies with microcephaly report having symptoms associated with Zika virus early in their pregnancies.

A Cause Map, a visual root cause analysis, can be built to illustrate what is known about this issue as this time.  As more information becomes available the Cause Map can easily be expanded to incorporate new information.  A Cause Map is built by asking “why” questions and laying out all the causes that contribute to an issue to show the cause-and-effect relationships. Understanding all the causes that contribute to an issue can aid in development of effective solutions.

In this example, more evidence is needed to confirm that Zika virus is responsible for the microcephaly increase in babies.  (A box with a question mark on a Cause Map indicates areas where more information is required.) The timing of the increase in microcephaly cases and the spread of Zika virus is certainly suspect, but additional data will be needed to ensure that other factors aren’t involved as well.  An autopsy on a baby born with microcephaly revealed the presence of Zika virus, which is another data point, but again isn’t enough to conclusively prove the connection between Zika virus and microcephaly.

Tracking cases of Zika virus is difficult for several reasons.  Many people infected with Zika virus have no symptoms so it is difficult to determine exactly how many have been infected, including pregnant woman.  Zika is spread by mosquitos so everyone in the region is potentially exposed.  Only a few labs in Brazil have the capability to test for Zika virus which makes researching the virus more difficult.  Scientists are working on solving this mystery as quickly as they can, but reality is it will likely be some time before the connection between Zika virus and microcephaly is definitively proven or disproven.

Health officials are working to reduce the number of mosquitos in Brazil, even going door-to-door to look for potential breeding locations.  Reducing the number of mosquitos should hopefully reduce the number of cases of microcephaly if the suspicion about the involvement of Zika virus is correct.  Additionally, pregnant women are encouraged to stay indoors and wear plenty of insect repellant to prevent mosquito bites.  And of course, woman may want to avoid pregnancy as recommended until the mystery is solved, but this obviously isn’t always possible or practical.

To view an initial Cause Map of this issue, click on “Download PDF” above.

Root Cause Analysis

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.

Never Event, Root Cause Analysis

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.

Root Cause Analysis

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.

Root Cause Analysis

Patient Discharged Alone, Without Being Treated

By ThinkReliability Staff

A patient with schizophrenia and dementia was discharged from a New York City emergency room alone and without effective treatment. Less than two hours after her discharge, she was taken via ambulance to another hospital, which performed emergency surgery on a perforation in the digestive tract. However, because of various communication issues, the family was not notified of her whereabouts until three days later.

Multiple factors were involved in this issue. To provide some clarity about what happened, and where the investigation should go next, we can put the information that is known into a Cause Map, or visual root cause analysis. The Cause Map can be expanded as more information is known.

The first step of any problem investigation is to determine what problem needs to be solved. Rather than attempting to define a complex issue as just one “problem”, the problem is defined as the impact to an organization’s goals. In this case, patient safety was impacted due to the risk of injury to the patient. The regulatory goal is impacted due to the risk of a lawsuit or other regulatory action. Patient services were impacted because of the improper discharge. Additionally, the labor/ time goal is impacted because of an investigation, which the “first” hospital (or regulatory agency) should be performing, although the hospital has not released any information, citing privacy concerns.

The second step of a problem investigation is the analysis. We begin the analysis with one of the impacted goals. To develop the cause-and-effect relationships that make up the Cause Map, we ask “why” questions. In this case, the patient safety goal was impacted because of the risk to the patient. The risk was caused by being discharged alone, and also by being discharged without proper treatment. Because both of these causes resulted in the impact, they are joined with an “AND”. The patient was discharged improperly based on a decision to discharge the patient. Because the first hospital has not released any more details, we have to end that line of questioning with a “?”. However, once the causes related to the patient being improperly discharged are determined, solutions that will improve the discharge process to reduce the risk of other patients being improperly discharged can be brainstormed and implemented.

To ensure the analysis is complete, the other impacted goals must also be addressed. In this case, the labor/ time goal is impacted by the investigation. The investigation results from the patient being discharged improperly (also an impact to the patient services goal) and the hospital’s delay in notifying the family of the patient’s whereabouts. The second hospital did not have the family’s contact information because it was unable to receive it from the first hospital. This is another area that will need to be investigated further. Although the second hospital treated the patient after deeming it was an emergency, the second hospital had no way of contacting the patient’s family. This is particularly important in this case as the patient’s son was designated to make medical decisions for her. Additionally, even though the second hospital notified the first hospital it was treating the patient on the day the patient went “missing”, the first hospital, despite frequent contact with the patient’s family, did not pass that information along until three days later. The communication breakdowns at the first hospital must be addressed.

The third step of a problem investigation is to determine solutions to reduce the risk of similar issues recurring. In this case, more detail is needed about the discharge and communication processes. The solutions will ideally improve those processes to ensure that discharges and communication about patients are made following proper protocol.

To view the initial problem investigation, or Cause Map, click on “Download PDF” above. Click here to see our previous blog about intentional improper patient discharge, or “patient dumping”.

Root Cause Analysis

Equipment, procedural failure lead to resident scalding

By ThinkReliability Staff

While equipment and procedures were both in place to prevent resident scalding from too-hot baths, failures of both resulted in a resident receiving serious burns on August 13, 2013. The Health and Safety Executive (HSE) report was recently released on the incident, which resulted in prosecution for the care home and the employee responsible for the bath.

This incident illustrates the limitation in looking for the “one” root cause. There wasn’t just one thing that resulted in this incident; rather multiple failures were required to result in the tragic scalding. We can show these causes by performing a visual root cause analysis, known as a Cause Map. Note that the term “root cause” refers to a system of causes, much like the root of a plant is a system.

We begin the analysis by looking at the impact to the goals. Resident safety was impacted due to the very serious burning of a resident. The burning was so severe it resulted in the amputation of ten toes and the resident will never walk again. In addition, employee safety is impacted because of the emotional impact to the employee (known as the second victim). The employee safety is also impacted due to a risk of burns. The environmental goal is impacted due to the lack of temperature control and the compliance goal is impacted due to the prosecution of both the employee and the care home. Resident services are impacted from a resident being placed in a scalding bath. The failure of a thermostat is an impact to the property goal and the time required for response and investigation is an impact to the labor and time goal.

Beginning with one of the impacted goals (in this case we’ll begin with the resident safety goal) and asking “why” questions develops the cause-and-effect relationships that caused the incident. In this case, the resident’s injuries resulted from being placed in a scalding bath and being unable to exit due to physical and communication limitations. The resident was placed in the too-hot bath because the water in the bath was too hot, and the caregiver placed the resident in the bath. Both of these things (the water temperature being too high, and the caregiver placing the resident in the bath) had to occur in order for the injury to occur.

The water temperature was too high because of the failure of the immersion heater thermostat. The reason for the failure, as well as how long it was not working, is unknown. The caregiver placed the resident in the bath because she did not check the water temperature and failed to realize it was too hot. The caregiver appears to have been unaware of the thermostat failure, or certainly there would have been other safeguards in check. Additionally, there were inadequate thermometers provided to check the water temperature. (A manual check for comfort was still possible, though in this case could have resulted in a burn to the employee.) Although it was “required” to test the water temperature and record that the check had been done, there were no written instructions to that effect.

The care home has purchased portable thermometers for caregivers’ use, but the HSE also recommends the use of a secondary thermostatic cut-out, which would prevent boiling of the water tank even if the thermostat failed. The HSE has also provided a white paper “Managing the risks from hot water and surfaces in health and social care“, that discusses appropriate risk assessments and control measures to prevent burns of vulnerable care home residents.

To view the Cause Map of this incident, click “Download PDF” above.

Or, click here to read the HSE report of the incident.

Root Cause Analysis

Price of Daraprim jumped ~5,000%

By Kim Smiley

The cost of prescription drugs have been in the news the last several years as the United States struggles to deal with rising health care costs, but few stories have come close to generating as much outrage as the recent massive price increase of Daraprim.  As new specialty drugs hit the market, they are often expensive as drug companies recoup the costs of development and maximize profits while the drug is covered by patents, which may be frustrating but is understandable.  That is not what happened in the case of Daraprim, a lifesaving drug used as an antimalarial drug and to treat toxoplasmosis.  The medication has been around since the 1950s and isn’t covered by any patents.

So why has the price of Daraprim suddenly increased about 5,000 percent?  A Cause Map, or visual root cause analysis, can be used to intuitively show the causes that contributed to the issue.  (To view an outline and a High Level Cause Map, click on “Download PDF” above.) This is one of those issues where it may be tempting to identify the “root cause” or focus on a single cause that contributed to the issue, but there are many factors that need to be considered.  The piece of the puzzle that is probably the easiest to focus on is the fact that a new company bought the only company with regulatory approval to sell the drug in the United States and significantly raised the price.  Basically, there is demand for the drug and the company which has a monopoly on the supply in the US took advantage of it by increasing the price per pill from $13.50 to about $750.

The CEO of the company has been widely villainized for what many consider a predatory price increase, but it is important to remember that the Daraprim price increase was legal.  Many find the price increase distasteful, but there are currently no laws or regulations that prevent huge medication price increases, which is another cause that contributed to the issue.

While a generic version of the drug is available in many other countries for less than a dollar a pill, it cannot be sold in the US without going through a lengthy and expensive approval process. Possible solutions to prevent similar price increases in the future could be to create laws that limit price increases on drugs without patents on them or to increase the supply of medications sold in the US by allowing some sort of reciprocal approvals with countries that have strong regulatory systems in place.  A senate committee is requesting documents and information relating to the pricing of Daraprim and several other medications and there are lawmakers pushing to create legislation that would limit price hikes.

Another enterprising company seems to have found their own solution to the problem of the high cost of Daraprim – creating a cheaper alternative. Imprimis Pharmaceuticals has stated that they will produce a substitute drug that will be priced as low as $99 for a 100 pills.  The alternative drug isn’t a generic version of Daraprim, but rather a compounded drug that combines two FDA approved drugs (pyrimethamine, the only ingredient in Daraprim, and leucovorin) that are often used together.  The compounded drug would not be FDA approved, but doctors can prescribe it specifically for a patient based on the rules governing compounded medications.

It isn’t as elegant as having another FDA-approved supplier of Daraprim, but it seems like a viable work-around for many patients.  It also seems like satisfactory justice for the price of 60-year-old pyrimethamine drugs to end up cheaper in the US after they were hiked up to such high levels.

Root Cause Analysis

Handwashing is effective at fighting disease – so why doesn’t it happen more?

By ThinkReliability Staff

Global Handwashing Day is October 15. It’s very clear that handwashing can prevent disease – one study showed that it resulted in a 30% reduction in episodes of diarrhea; another study showed it could reduce the risk of respiratory infections by 16%. Yet proper handwashing is still not happening in many places. It’s estimated that the rate of handwashing is less than 20% in some developing countries.

There are multiple reasons that effective handwashing may not be occurring. We can look at these issues, as well as some of the solutions that have been suggested or implemented to increase the rates of handwashing, in a Cause Map, or visual root cause analysis. This method, like other problem-solving methods, involves three steps to define the problem(s), analyze the issues that may cause the problems, and brainstorm solutions that will reduce the risk of the problem(s) recurring.

In Cause Mapping, the problem is defined as the impact to an organization’s goals. In this case, the goals are broad and impact the population of most of the world. The risks of increased disease (particularly diarrhea and respiratory infection) impact the public safety goal. Contamination of handwashing water is an impact to the environmental goal.

The cause-and-effect analysis begins with the impacted goals. Asking “why” questions allows us to determine the causes that resulted in the impacted goals (or effects). It has been established (by the previously mentioned studies, as well as others) that the public safety impacts of increased risk of disease result from ineffective handwashing (or no handwashing at all).

Proper handwashing involves 3 things: clean water, soap, and time. Lathering with soap for about twenty seconds detaches oils and microbes from the skin and water washes it away. Removing any one of these things results in an ineffective wash, and there are multiple reasons why this could occur.

If no soap is available, washing won’t be able to remove disease-causing microbes. Obtaining soap may be difficult due to cost or availability. If soap is obtained, it may be eaten by goats (seriously, goats eat everything) or may not be used if it doesn’t smell good. Solutions suggested include making a protective cover to protect the soap from goats, finding less expensive soap supplies, or creating hand soap out of laundry soap and water. Hardening soap in the sun can help it last longer. Some groups have also started developing nicer-smelling, inexpensive soap or allowing donation of leftover pieces of soap from hotel use.

Even with soap, washing for a period of time (about twenty seconds) is required to give it time to fully remove germs and oils. Various versions of handwashing jingles (songs about the importance of handwashing that last at least the required amount of time) have been developed and are being spread across many areas of the world.

Lastly, even if handwashing involves lathering with soap for at least twenty seconds, if the soap is then rinsed off using contaminated water, the contamination will spread to the just-washed hands. In areas where there is no running water, water used for handwashing can be contaminated when dirty hands or ladles are dipped into the water. To reduce the risk of contamination, many areas use plastic containers that contain a tap that drips out water to use for handwashing.

Even with these difficulties, handwashing remains the most effective, inexpensive way to prevent disease across the globe. No matter where you live, it’s important to wash your hands properly and frequently, to fight the spread of disease.

To view the Cause Map and solutions related to this issue, click “Download PDF” above. Or, click here to read more.

 

Root Cause Analysis

Lethal-Injection Drug Mix-up

By ThinkReliability Staff

On January 15, 2015, a prisoner was executed by lethal injection in Oklahoma. On October 8, the autopsy report, showed that prisoner had been injected with potassium acetate instead of potassium chloride as intended.

This was the first injection to take place in the state since a prisoner took 43 minutes to die after the drugs were administered in April 2014 (see our previous blog about this execution).  After that, further executions were stayed.

Just hours prior to the first execution scheduled since January, Department of Corrections personnel realized they were sent potassium acetate instead of potassium chloride and that execution was called off.  Shortly afterwards, an Oklahoma court granted an indefinite stay for the prisoners who were scheduled for execution.

While there is ongoing debate about whether the change adversely impacted the speed or humaneness of the execution, it certainly caused great concern about the ability of the state of Oklahoma to correctly perform an execution.  Says an attorney, “The state’s disclosure that it used potassium acetate instead of potassium chloride during the execution of Charles Warner yet again raises serious questions about the ability of the Oklahoma Department of Corrections to carry out executions.”

Along with the concern for ability to perform future executions, there is potential safety impact regarding the prisoner’s suffering, as well as the production impact resulting from the delay in future executions.  The ongoing investigation will also impact goals because of the resources required.  This investigation will attempt to determine how the wrong drugs were used in the execution.

In case of the execution scheduled for September, the wrong drug was placed in the syringe used to inject the prisoner, and there was an ineffective verification of the drugs.  It’s unclear whether there was an attempt at verification that the drugs being used were correct.  If there was such a check, verification may have been difficult because records show that the syringe was labeled potassium chloride (the desired drug).

Department of Corrections records also show that the state received potassium acetate instead of the desired potassium chloride.  It seems that the potassium acetate was accidentally delivered from the supplier (there doesn’t appear to be a need for potassium acetate).  According to the prisons director, the supplier believed that the drugs were interchangeable.  In general, the oversight of suppliers who provide lethal injection drugs is limited – many states refuse to disclose their suppliers and many suppliers are compounding pharmacies, which are subject to less regulation.

Oklahoma does have several different combinations and substitutions of drugs allowable for executions, but there is no approved substitute for potassium chloride.  This, and recent changes to suppliers because so many refuse to supply drugs for lethal injection, may have led to some confusion.

It’s likely that solutions, or changes to the execution protocol may not be discussed until after the investigation is complete.  A completely different type of execution may be considered: in April 2014 Oklahoma approved nitrogen gas the backup method for executions if lethal injection could not be used.  Based on all the recent issues and concerns, that new method may be under consideration.

Root Cause Analysis

Why You Will Experience a Diagnostic Error

By ThinkReliability Staff

On September 22, 2015, the Institute of Medicine released a report entitled “Improving Diagnosis in Health Care“. The report was the result of a request in 2013 by the Society to Improve Diagnosis in Medicine to the Institute of Medicine (IOM) to undertake a study on diagnostic error. The tasking to the committee formed by the IOM matched the three step problem-solving process: first, to define the problem by examining “the burden of harm and economic costs associated with diagnostic error”; second, to analyze the issue by evaluating diagnostic error; third, to provide recommendations as “action items for key stakeholders”.

The burden of harm determined to result from diagnostic errors is significant. Diagnostic errors are estimated to contribute to about 10% of hospital deaths, and 6-17% of hospital adverse events, clearly impacting patient safety. Not only patient safety is impacted, however. Diagnostic errors are the leading type of paid malpractice claims. They also impact patient services, leading to ineffective, delayed, or unnecessary treatment. This then impacts schedule and labor as additional treatment is typically required. The report found that, in a “conservative” estimate, 5% of adults who seek outpatient care in the United States experience a diagnostic error each year and determined that it is likely that everyone in the US will likely experience a meaningful diagnostic error in their lifetime.

The report also provided an analysis of issues within the diagnostic process (to learn more about the diagnostic process, see our previous blog) that can lead to diagnostic errors. Errors that occur at any step of the diagnostic process can lead to diagnostic errors. If a provider receives inaccurate or incomplete patient information, due to inadequate time or communication with a patient, compatibility issues with health information technology, or an ineffective physical exam, making a correct diagnosis will be difficult. Ineffective diagnostic testing or imaging, which can be caused by numerous errors during the process (detailed in the report). Diagnostic uncertainty or biases can also result in errors. However, not all errors are due to “human error”. The report asserts that diagnostic errors often occur because of errors in the health care system, including both systemic and communication errors.

When diagnostic errors do occur, they can be difficult to identify. The data on diagnostic errors is sparse due to both liability concerns as well as a lack of focus historically on diagnostic errors. In addition, there are few reliable measures for measuring diagnostic errors, and diagnostic errors can frequently only be definitely determined in retrospect.

The report identifies eight goals for improving diagnosis and reducing diagnostic errors that address these potential causes of diagnostic errors. These goals are presented as a call to action to health care professionals, organizations, patients and their families, as well as researchers and policy makers.

To view a high-level overview of the impacts to the goals, potential causes and recommendations related to diagnostic error presented in a Cause Map, or visual root cause analysis, click on “Download PDF” above. To learn more:

To read the report, click here.

For an overview of the diagnostic process, click here.

For an example of a diagnostic error with extensive public health impacts, click here.