Tag Archives: healthcare

Root Cause Analysis

Unbalanced Antidepressant Use

By Kim Smiley

A recent Centers for Disease Control and Prevention report provided results of a study of Americans taking antidepressants from 2005 to 2008.  The study came to two interesting conclusions that have a potential impact on patient safety.  We can outline the potential impacts of the results of this study in a problem outline, then provide a graphic analysis of the causes within a Cause Map, or visual root cause analysis.

First, the study determined that antidepressant use has increased 400% since 1988.  Eleven percent of Americans over the age of 12 are now taking antidepressants.  Any drug has risks, and more people taking a drug means that the total risk for side effects is higher.  Additionally, traces of certain kinds of antidepressants have been found in  the water supply, likely caused partially by improper disposal of these drugs.  (Don’t flush them down the toilet!)  The cost of anti-depressants is an additional issue raised with the high usage of these drugs.

Even though talk therapy is a very useful tool for treating depression, less than 1/3 of patients who are taking antidepressants have met with a mental health professional in the last year.  Patients reportedly prefer drugs to talk therapy, potentially because reimbursement for prescriptions is generally much simpler and cheaper than reimbursement for mental health therapy, which can be capped or may not be covered at all.

Because most antidepressants are obtained with a prescription, the higher usage of antidepressants indicates a higher rate of diagnosis of depression.  While the faltering economy can take some of the blame, hormonal changes (as middle aged women are the most frequent users of antidepressants), a decreased stigma against depression, and increased awareness of the drugs, thanks to pharmaceutical marketing, have also been listed as potential causes for the increase.

Many agree that the decreased stigma towards depression is a positive step; however, the other side of the study found that only one third of people with severe depression symptoms are taking antidepressants.  While many with mild depression symptoms may find relief with talk therapy or other options, American Psychiatric Association guidelines recommend medication for moderate to severe depression symptoms.  This indicates that patients with severe depression may be under medicated and increases the risk for mental health problems and/or suicide.  There are many possibilities for why individuals with severe depression are not getting – or seeking – the help they need.  The high out of pocket cost for anti-depressants may be a barrier to some, as is the ability to receive screening for depression.  Although there are certainly other roadblocks along the way, making screening easier to receive may increase the treatment rate for sufferers.  The Centers for Medicare and Medicaid Services recently announced it would be covering annual screening for depression.  Hopefully this first step will result in more people getting the help they need.

To view the Outline and Cause Map, please click “Download PDF” above.  Or click here to read more.

Root Cause Analysis

Fixes Don’t Have to be Complicated

By Kim Smiley

The main goal of doing root cause analysis is to get to the solutions at the end.  The actual analysis portion serves to provide a comprehensive, orderly way to get to those solutions.  The best way to get solutions is brainstorming by all the personnel who have a stake in the issue – and maybe some who don’t.  The New York Times recent series on “small fixes” has highlighted some amazing developments that are helping to mitigate a large number of healthcare issues, in extremely easy ways.

For example: Pap smears are frequently used to diagnose cervical cancer in wealthy countries.  But what about countries that don’t have enough doctors or labs to make this a practical solution?  Increasing the number of doctors or labs is an extremely long-term, complicated solution.  Instead, Johns Hopkins developed a new procedure that can be done in one visit by a nurse, without lab work.  You brush vinegar on the cervix, precancerous cells turn white, and they’re frozen off right then with carbon dioxide.

Another organization, Diagnostics for All, has developed paper diagnostic forms  for a whole host of diseases, which are smaller than a stamp, can be run off on a Xerox machine, cost less than a penny and can be read without training.  Although these end results are inexpensive and accessible, the path to get there may be more complicated.  Diagnostics for All is supported by grants and foundations, but that kind of support is getting harder to find as the economy continues to worsen.  Additionally, profit for items designed primary to assist developing countries are limited.

There’s also the general feeling that expensive, complicated fixes must be better.  Some of the most effective fixes for healthcare issues – washing hands, using checklists, losing weight – are still not universally used and are constantly in danger of being replaced with costly, cumbersome alternatives.  Sometimes it’s just that people don’t believe something simple can be effective.  Sometimes it’s that the people who have been seeing these problems for years believe that if a solution were that easy, it would have already worked, and something more invasive and expensive is needed.  And, sadly, a lot of it comes down to profit.  Expensive machines, diagnostics and procedures simply make everyone involved more money than using vinegar, paper, and soap.  It’s possible, and hopeful, that the changes in the economy will start turning things in a different direction.

How can you start implementing small fixes in your organization?  First, get everyone involved in the root cause analysis and solution brainstorming.  Bring in a few people who don’t appear to have anything to do with the issue.  Explain the issue to them and let them come up with a few solutions.  Their fresh voice may result in a fresh idea.  Examine all potential solutions for ease of implementation and projected effectiveness.  If you’ve got an idea that’s easy to implement, go ahead and implement it.  If it doesn’t work, or more help is still needed, go on to the more difficult-to-implement solutions.  Start an idea box.  It’s free, it’s easy, and you may be surprised what people come up with.  The New York Times has its own “Small Fixes Challenge” It posts a healthcare problem, explains the details of the issue, and invites reader ideas.  The ideas are reviewed by a healthcare professional well-versed in the topic.

Try a small fix in your organization today.  Ask someone what they see as an issue in the organization.  And then ask them what they’d do to fix it.  A great way to get a variety of responses is ask for the “money is no object” fix, a “free” fix, and then a fix somewhere in the middle.  The answers may surprise you.  And they might have a great idea with their “free” fix.  So, what are you waiting for?  Like all small fixes, it’s worth a try.

Root Cause Analysis

Drug Shortages in the US

By Kim Smiley

The FDA has reported a record number of drug shortages in 2010 that is continuing to increase into 2011.  Some of the drugs included in this shortage are chemotherapy drugs.  Providers across the U.S. are reporting that the shortages may endanger patients if they are unable to receive the necessary drugs.  In some cases, drugs that are more expensive, less effective, or both are being used.  Or, patients are turning to the “grey market”, buying drugs of questionable safety that have, in most cases, been significantly marked up.  Additionally, because already approved drugs are needed for clinical trials, some clinical trials have been delayed, limiting the addition of new medications.

We can look at this issue in a Cause Map, a visual root cause analysis.  A Cause Map connects the impacts to the goals of an organization, or in this case, the U.S. healthcare system.  The patient safety goal is impacted because of the risk to patient health.  The organization goal is impacted because of delayed clinical trials.  The patient services goal is impacted because of the lack of needed medication.  Also, the property goal is impacted because of the replacement with more expensive medications.  We use these goals as the basis for our Cause Map, then ask “Why” questions to complete the analysis.

Insufficient supply is caused by demand greater than supply.  Both of these factors can contribute to the overall effect.  Although there are several reasons for increased demand, the most pertinent to this issue appears to be hoarding – where physicians hear of shortages and are attempting to create a stockpile for their patients.   However, increased insurance coverage and general increased need for medication for diseases such as cancer are also likely contributing.

Reduced supply is also contributing to the shortage.  Shortage of raw ingredients is considered to account for about 10% of the issue, with quality issues and insufficient production accounting for the rest.  In some cases, manufacturers are believed to be limiting their production – or ending it all together – because the drugs do not provide much profit.  Many of the limited drugs are generics, which do not provide as much profit as name brand drugs, especially as drug profits were limited by the Medicare Prescription Drug, Improvement and Modernization Act of 2003, which limited price increases in an attempt to limit Medicare spending.  The resulting drug shortage – which is sometimes resulting in paying for much more expensive drugs – is certainly an unintended consequence of this act.

Despite best intentions, changes made to fix an identified problem may in fact cause another one – sometimes one that is far greater.  This is why follow-up to implemented solutions must occur at regular intervals, and must include a comprehensive assessment of whether the solutions are effective.

Some of the solutions recommended to prevent the issues caused by these drug shortages are to create a national stockpile of certain kinds of drugs and requiring notification to the FDA of  supply shortages.  In the meantime, the FDA is providing guidance to patients and providers to attempt to ease the ongoing issues.

Root Cause Analysis

Working to Ensure Safe Assembly of Surgical Tools

By ThinkReliability Staff

A 2-month old was undergoing a cystoscopy to incise a ureterocele in the bladder.  During the endoscopic procedure, a resectoscope was used to remove the unwanted tissue.  However, during the operation part of the resectoscope slipped off, exposing a hook-shaped internal piece of the instrument.  Fortunately the patient was not injured; however the potential for injury was very real.  How did the medical instrument come apart?

The first step in an incident investigation is to determine what the problem is and what the impacts to the organization’s goals are.  In this case, the problem is fairly straightforward – the resectoscope fell apart while inserted into a patient.  Although details are scant in this case, the problem statement is filled out as completely as possible to document what occurred.  The second part is to determine the impact to the organization’s goals.  An obvious impact is the potential harm to the patient, related to the hospital’s patient safety goal.  There was also the possibility of legal action, which would impact property goals.  Finally, there likely was the need to redo the procedure, taking additional time, thus impacting the organization’s labor goal.

The second step is to build a Cause Map by asking why an event occurred.   The Cause Map visually depicts what led to the young patient being exposed to harm.  In this case, the three goal impacts converge on the event where the hook electrode became uncovered.  It should be noted that multiple causes led to the patient being exposed to harm; if the resectoscope had been broken but had not been in use, then it would not have mattered.  It is crucial to include all reasons on the Cause Map because those reasons may be key to developing the optimal solution.

Facts that need to be captured about an investigation can be included in evidence boxes on the Cause Map.  They can provide the reader with important background information.  In this example, information about the hook electrode is included so that the reader knows what it is.

Reviewing the complete Cause Map, it turns out that the resectoscope was incorrectly assembled.  The third step in an incident investigation is to develop a set of solutions.  Remembering that all causes are necessary to produce an effect, the investigation team can brainstorm solutions to eliminate or counteract contributing causes.  In this case, three possible solutions were developed.  It is possible that the resectoscope could be designed differently so that the insulation would not be able to slip.  While this is a reasonable long term solution, it would not immediately remedy the problem.  Another solution would be to verify that the instrument is in working order before using on a patient.  This may have occurred, but it should be included until ruled out as a potential solution.  A final idea is to revise the assembly procedures for the resectoscope.  This is in fact what the FDA recommended.

The FDA recommends that the manufacturer’s assembly procedures always be carefully followed.  A process map is another helpful tool to determine where something went wrong.  The organization can build a process map depicting the ideal sequence of events, then compare that with what actually occurred.  The problem may not be in the instructions; the instructions might be perfect!  However, if someone doesn’t follow those instructions correctly, the process isn’t going to reach the desired outcome.

At this point, the investigation team might go back to the Cause Map to elaborate on the why the resectoscope was incorrectly assembled.  This might generate new solutions and changes to the ideal process map.  Through this iterative process, an optimum solution can be found.

This event was reported as part of the FDA’s MedWatch program.  The FDA encourages health professionals to voluntarily report problems on medical devices.  For more information on the MedWatch program, please visit their website.

Root Cause Analysis

Infants Exposed to Unnecessary Radiation

By ThinkReliability Staff

A recent New York Times article, X-Rays and Unshielded Infants, used an example of poor x-ray technique issues to highlight problems with the operation of radiation equipment in the medical industry.

In 2007, a director at a medical center in Brooklyn, New York discovered that premature babies were routinely being over-radiated during x-rays.  Full body x-rays of babies, known as “babygrams” were being done when not medically necessary. When a simple chest x-ray was ordered, as is common for premature babies with lung issues, the entire body was being x-rayed without any shielding.  Additionally, the CT scanners had been set too high for infants in some cases.  There were also issues of poor body positioning that made it difficult for doctors to accurately read the x-rays.

The end result was that many young babies were being habitually exposed to unnecessary radiation at this facility.  This is especially troubling when you consider the fact that children are particularly vulnerable to radiation exposure because their cells divide more quickly because they are still growing.

The causes in this example aren’t well known, but a basic Cause Map can be started and could be expanded if more information becomes available.  Click on “Download PDF” above to view the Cause Map.

What is clear is that this is more than a case where one person made a single error.  The culture and training in the department didn’t recognize the importance of limiting radiation exposure.  The radiation field as a whole is also minimally regulated.  Standards and regulations are decided at the state level and many states choose not to regulate all occupations working with radiation.  In 15 states radiation therapists are unregulated, 11 states don’t regulate imaging technologists and medical physicist are unregulated in 18 states. For the past 12 years, the American Society of Radiologic Technologists has lobbied for a bill to set education and certification requirements for people working in medical imaging and radiation therapy, but as of yet no bill has been passed.

After the improper radiation techniques were discovered, the hospital instituted many changes to their procedures.  No more full body x-rays were performed and shielding was used to minimize radiation exposure for children as well as adult patients. An investigation is also underway by the New York state health department.

Root Cause Analysis

Number of Gout Cases Continues to Increase

By Kim Smiley

Gout was historically known as “the disease of kings” or “rich man’s disease” and has long been associated with rich food and excessive alcohol, but recently gout has become a common problem across all socio-economic classes.  More than six million adults in the US have gout and the number will likely keep rising in the future.

Gout occurs when there are high levels of uric acid in the blood stream.  Excessive uric acid forms crystals that collect in joints and soft tissues, causing acute pain and inflammation.  Uric acid is produced when the body processes purines.  Purines are found naturally within the body and are also found in many types of food, including meat (especially organ meat), anchovies, herring, asparagus and mushrooms.

Why are more people suffering from gout? This issue can be investigated by creating a Cause Map and performing a root cause analysis to determine what causes contribute to the problem. (Click on the “Download PDF” button above to view a high level Cause Map of this issue.)

Digging through some of the data available, it becomes clear that the modern diet is one cause, but there are a number of other causes that contribute to gout including higher life expectancy, higher weights, and modern medications.  Risk of gout is also higher for people who suffer from a number of illnesses, including hypertension, diabetes, high cholesterol and congestive heart failure; all diseases which are more common now than they were in the past thanks to advances in modern medicine and increased life expectancy.  Obesity also makes gout more likely and today’s population is heavier on average.  There are also several medications that have been shown to increase the risk of gout, including medicines commonly used to treat high blood pressure and low-dose aspirin.

Gout has typically been considered a man’s disease, but now more women are suffering from it. Prior to menopause, woman naturally have lower levels of uric acid in their blood, but as women live longer more cases of gout are developing in women.

Looking at the risk factors associated with gout, it’s clear why more and more people are suffering from it.  Some risk factors can’t be changed, such as gender or age, but staying healthy overall can reduce the likelihood of suffering from gout.

Root Cause Analysis

Hungover Surgeons More Likely to Err

By ThinkReliability Staff

The headline probably isn’t shocking to anyone who’s woken up the next morning with a pounding headache and dry mouth.  Clearly one’s performance at work is going to be impacted by a night of unabated drinking.  However a recent Irish study, published this month in the Archives of Surgery, show surprising results regarding the lingering effect of alcohol consumption.  Their findings show that well into the day surgeons are more likely to make mistakes.

Modern surgical techniques, including laparoscopic surgery, require great manual dexterity and control as well as sustained mental focus.  It is common knowledge that both of these skills are impaired while intoxicated.  What is unknown is how these skills are impaired after one is no longer intoxicated, but obviously still affected.  In all but one test subject, their blood alcohol content (BAC) had returned to 0.00%.  Initial testing done in the morning showed no significant difference between test and control subjects, however later in the day there was a perceptible decline.  While the study was only a preliminary one, it indicates that more research is needed in this area.

A Cause Map can be especially helpful in a research environment because it helps define causal relationships.  In this case, the researchers focused on the effects of drinking the night previous.  But perhaps there are other reasons at play, such as fatigue, which contribute to the effect.  When searching for causes it is important not to focus in on one aspect, ignoring others, since all causes are required to produce an effect.

It is expected that surgeons wouldn’t actually drink while at work.  However, there are surprisingly no guidelines about when they should stop drinking beforehand.  Pilots are federally mandated not to drink at least 8 hours prior to flying or fly with a blood alcohol content (BAC) of .04% or greater.  Perhaps this study will generate an overdue discussion on the need for abstention prior to surgery.  Potential solutions, such as training or regulations, can be displayed directly on the Cause Map above the appropriate cause.

Root Cause Analysis

Reducing Stillbirth Rates Worldwide

By ThinkReliability Staff

Stillbirth is the loss of a pregnancy after 22 weeks gestation.  Around 2.6 million stillbirths occur every year around the world, primarily in developing countries.  However, the kind of attention being addressed to other issues in the developing world has not been focused on stillbirth, leading the rates of stillbirth to decrease more slowly than other death rates.  In an attempt to draw more attention to this issue – with its profound impact on the family and community – the Lancet has published a series of articles on stillbirth, addressing some of the impacts, causes, and a plan to reduce the number of stillbirths in half by 2020.

The information provided by this comprehensive series can be summarized visually within a Cause Map.  A thorough root cause analysis built as a Cause Map can capture all of the causes in a simple, intuitive format that   fits on one page.  We begin the Cause Map much as the series begins – with a focus on the impacts of stillbirth, beginning with the 2.6 million deaths per year.  We can consider this an impact to the public safety goal.  A related impact is an impact to the public safety goal – lack of access to quality care.  Starting with these two goals, we can begin an analysis of the problems contributing to stillbirth.

Although the data collection for stillbirth lacks consistency, there are five major causes of stillbirth that we’ll address here: fetal growth restriction, childbirth complications, maternal infection, maternal disorders, and congenital abnormalities.  At a very, very high level, we can discuss some of the causes of these issues, which the Lancet series hopes to address in order to halve the number of stillbirths by 2020.

Fetal growth restriction can be caused by inadequate prenatal care.  Increased fetal growth restriction detection and management is expected to reduce the number of stillbirths by 107,000 per year.  Childbirth complications can be caused by lack of quality obstetric care and/or labor past 41 weeks.  Comprehensive emergency obstetric care is expected to reduce yearly stillbirths by 696,000 and  identification/induction of women who are past 41 weeks gestation is expected to reduce another 52,000.

The main maternal infections of concern are malaria and syphilis.  Additional malaria prevention (such as insecticide treated nets) would reduce annual stillbirths by 35,000 and syphilis detection/treatment another 136,000.  Maternal disorders of concern are mainly diabetes and hypertension. Detection and management of maternal diabetes and hypertension would prevent 24,000 and 57,000 stillbirths per year, respectively.  Congenital abnormalities can be caused by insufficient folic acid intake at and after conception.  Increased access to folic acid supplementation would save 27,000 lives.

If all of these recommendations can be fully implemented, more than 1 million stillbirths could be prevented each year.   Far more detail can be added to this Cause Map, depending of the level of analysis required. As with any investigation the level of detail in the analysis is based on the impact of the incident on the organization’s overall   goals.  To see the outline, Cause Map, and solutions, please click “Download PDF” above.  To learn more about stillbirth, and the goals, please see the Lancet series.

Root Cause Analysis

Kidney Transplant Mix-up

By ThinkReliability Staff

On January 29, 2011, a kidney was transplanted into the wrong patient.  No one was injured, but this was known as a “near miss” – had things gone slightly differently, it could have resulted in severe consequences.  Namely, the patient who received the incorrect kidney could have been killed or seriously injured, had the kidney not happened to be compatible with that patient also.  (The kidney donor had Type O blood, known as the universal donor, which aided in the compatibility.)  The patient who was supposed to receive the kidney could have had a long wait back  on the transplant list.  Luckily, a new donor was found for the second kidney and a new kidney was found for the second donor fairly quickly.  Although there were no injuries, the high potential for injury results in an impact to the patient safety goal.

To try and help figure out what went wrong, we begin with the impacted goal and ask “Why” questions to fill out the analysis. We discover that there were two kidneys that arrived at the hospital simultaneously.  In order for the kidneys to be switched, the kidneys must have been mislabeled, or miss-identified once at the hospital.  The coordinating agency for transplants states that the packaging and labeling of the organs was correct.  We then turn our focus to the identification steps of the organ once at the transplant center.

To aid in determining where process improvements can be made, first we need to define the process.  We can do this with a process map – a step by step instruction of how a process is performed.  In this case, the steps for transplants have been developed by an outside agency – the United Network for Organ Sharing (UNOS).  We can outline these steps in our Process Map.  Because of the high risk for consequence should an error occur, the process is well-defined and consists of checks to ensure that mismatches do not occur.  The last highly publicized incident of a transplant error was in 2003 (see more about that incident here).

The hospital involved has not released details about what might have occurred in the process; however, it’s certain that they’re looking at the process with a fine-tooth comb and trying to implement improvements.  The transplant program has closed down while they’re doing so.

Root Cause

Developing a Meningitis Vaccine Program to Prevent Epidemics in Africa

By ThinkReliability Staff

Meningitis epidemics occur on a regular basis in Africa. Last year, there were more than 88,000 reported cases.  In 1996-1997, during the largest reported epidemic, more than 250,000 cases were reported.  Meningitis is highly contagious and approximately one in ten cases are fatal.  Disability occurs in approximately one in five cases.

The vaccine that was previously available in Africa was a polysaccharide vaccine, which did not prevent transmission of the disease. Understanding that the current situation was dire, the Meningitis Vaccine Project was formed.  With funding from various donors including The Gates Foundation and money raised in Africa, a vaccine that protects against the group A meningitis strain – responsible for more than eight out of ten infections in Africa – has been developed at a cost of less than $.50 (US) a dose.  More funding is still needed to meet the goal of vaccinating 300 million people across 25 nations.    However, the steps that have already been made are remarkable and represent a huge step forward in helping fight this dreadful disease.

Click on “Download PDF” to see the outline and Cause Map of the 1996-1997 meningitis epidemic and the timeline of the progress of the Meningitis Vaccine Project.  To learn more, see the Meningitis Vaccine Project.