All posts by Kim Smiley

Mechanical engineer, consultant and blogger for ThinkReliability, obsessive reader and big believer in lifelong learning
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

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

Child Paralyzed by Vaccine-Derived Polio

By Kim Smiley

There has been amazing progress in the effort to eradicate polio, but recent cases of the disease are a harsh reminder that the work isn’t complete and now isn’t the time to be complacent.  Public health officials are planning three mass vaccination rounds in less than 120 days after a child was recently paralyzed by polio in Mali.  In addition to this case, the World Health Organization (WHO) announced that two children in western Ukraine were also paralyzed by polio.

The last case of polio was detected in Mali in 2011.  A Cause Map, a visual root cause analysis, can be used to analyze how the child contracted polio as well as help in understanding the overall impacts of this case.  The first step in a Cause Map is to fill in an outline with the basic background information, including listing how the issue impacts the different overall goals.  This issue, like most, impacts more than a single goal.  For example, the child being paralyzed is an impact to the patient safety goal, but the potential for an outbreak of polio is an impact to the public safety goal.

Once the impacts to the goals are defined, the Cause Map itself is built by asking “why” questions and including the answers in cause boxes.  The Cause Map visually lays out all the cause-and-effect relationships that contributed to an issue.  So why was the child paralyzed?  The child was infected with vaccine-derived polio because he was exposed to the disease and wasn’t immune to it, likely because he didn’t receive all four of the required doses of vaccine.  Vaccine rates in Guinea, where the child was from, dropped during the Ebola outbreak.

In this region of the world, oral polio vaccine is used and it contains weakened, but live, strains of polio virus.  After being administered oral polio vaccine, a child will excrete live virus for a period of time.  The live virus can replicate in the environment and there is the potential for it to mutate into a more dangerous form of polio, which is what causes vaccine-derived polio.

Cases of vaccine-derived polio are very rare, but are a known risk of using oral polio vaccine.  The injectable vaccine uses dead polio virus that cannot mutate, but there are other important factors that come into play.  The oral polio vaccine is cheaper and is simpler to administer than the injectable vaccine because medical professionals are needed to give injections.

The use of oral vaccines also eliminates the risk of spreading blood borne illnesses.  Because there are no needles involved, there is no risk of needles being shared between patients.  The oral vaccine also provides greater protection for the community as a whole, especially in regions with poor sanitation.  When a child is fully immunized with the oral polio vaccine this ensures immunity in the gut so that the polio virus is not excreted after exposure.  This is not true with the injectable polio vaccine; an immunized child exposed to “wild” polio would not be infected, but may still excrete polio virus after exposure and potentially spread it to others.  One negative of using the oral polio vaccine is that in rare cases (estimated to be about one in about 2.7 million) the weakened polio virus can cause paralysis in a child receiving their first dose of the vaccine.  Concern over paralysis is one of the reasons that developed nations generally use the injectable polio vaccine.

Polio is highly contagious and public health officials are planning an aggressive vaccine campaign to reduce the risk of an outbreak now that a case of polio has been verified in Mali. The plan is to have three mass vaccination rounds in less than 120 days, a level of effort aided by the many World Health Organization and United Nations staff that are still in the area as part of the response to the Ebola outbreak.  Thankfully, Guinea has not reported any cases of Ebola for several months so officials can devote significant resources to the mass polio vaccine effort.

Root Cause Analysis

The difficulty of removing titanium rings

By Kim Smiley

Titanium rings have been growing in popularity because of their durability, strength, light weight and hypoallergenicity.  But unfortunately, the strength of titanium rings can become a problem if one ever needs to be cut off.  When a finger swells with a ring on it, blood flow to the finger is restricted and can cause tissue death in the finger so the issue of how to quickly and safely remove a ring can be quite serious.

Dr. Andrej Salibi, a plastic surgeon at Sheffield Teaching Hospitals in the U.K., recently described a case where a patient came to the ER after his finger swelled following a soak in a hot tub.  Normally, removing a ring from a swollen finger is a quick and relatively easy procedure, but in this case the patient was wearing a titanium ring and all the usual methods used to remove rings failed. Typically, a doctor would grab the ring cutter at this point and simply cut the ring off, but the titanium ring was too strong for a traditional ring cutter.  The fire department was called and attempted to use its own specialized cutting gear, but that also couldn’t cut through the titanium ring.  The patient had to be admitted to the hospital and spent (what I assume was a very uncomfortable) night with his hand elevated.

The next morning, the doctors decided to try something new – bolt cutters.  The bolt cutters finally cut through the metal, but the doctors still had to find a way to pull the metal apart. Using some large, heavy-duty paperclips, two doctors were able to pull the ring far enough apart that the man could slip his finger out.  Thankfully, the man’s finger is going to be fine with no long-term damage.

The bolt cutter solution worked so well, the doctors involved actually published a letter to share the idea with other physicians.  Bolt cutters are commonly available in a many hospitals, but not something that ER doctors may initially think to use.  There is other specialized equipment like dental saws or diamond-tipped saws which may be able to cut through titanium rings, but they aren’t generally readily available in a hospital setting and require more manpower to use.  The potential for accidentally injuring a patient’s finger during the removal process is also higher than with a simple bolt cutter.

Sometimes a simple solution can be the best solution and as this case study demonstrates, it is also important to document and share lessons learned.  Solving a single problem is a good thing, but sharing solutions so that the wheel doesn’t have to be reinvented the next time the problem is encountered is even better.  Maybe some doctor will read the letter published by the doctors involved in this case and a future patient will be spared an extra night of discomfort and unnecessary time in the hospital.

If you are in the market for a ring, you may want to consider carefully whether titanium is the right metal choice.  If you do choose titanium, you may want to stick with pure grade because it is significantly softer and easier to cut than aircraft grade, with has other metals mixed in.  It is also a good idea to remove all rings when working around machinery or if you notice your fingers swelling.

To view a Cause Map of this example, click on “Download PDF” above.

Root Cause

Medical Device Vulnerable to Hacking

By Kim Smiley

The Food and Drug Administration (FDA) made headlines when they issued a warning that a computerized pump used for infusion therapy, Hospira Symbiq Infusion System, has cybersecurity vulnerabilities. Hacking is scary enough when talking about a laptop, but the stakes are much higher if someone had the ability to alter the dosage of critical medication.

A Cause Map, a visual format for performing root cause analysis, can be used to analyze this issue.  The first step in the Cause Mapping process is to fill in an Outline with the basic background information, including how the issue impacts the overall goals.  Defining the impacts to the goals helps define the scope of an issue.  Once the Outline is completed, one of the impacted goals is used as the starting point to building the Cause Map itself.  For example, the potential risk of serious injury or death is an impact to the patient safety goal and would be the first cause box on the Cause Map.  The rest of the Cause Map is built by asking “why” questions and documenting the answers in cause boxes to intuitively lay out the cause-and-effect relationships.

So why is there potential for injury or death with the use of the Hospira Symbiq Infusion System?  It is possible for a patient to receive the incorrect dosage of medication because the system could be accessed remotely by an unauthorized user who could theoretically change the settings.  There have been no reported cases where this infusion pump system has been hacked, but both Hospira and an independent researcher have confirmed that it is possible.

This system is vulnerable to hacking because it is designed to communicate with hospital networks and the design has a software bug that could allow it to be accessed remotely via a hospital’s network.  The infusion system was designed to interface with hospital networks to help reduce medication dosage errors because the dosage information wouldn’t need to be entered multiple times.

The final step in the Cause Mapping process is to develop solutions to help reduce the risk of similar errors in the future.  In this specific example, the FDA has strongly encouraged healthcare facilities to transition to alternative infusion systems as soon as possible.  Hospira discontinued this specific design of infusion system in 2013, reportedly due to unrelated issues, but it is still available for sale by third-party companies and used by many healthcare facilities. There will not be a software patch provided or any other means to make the Hospira Symbiq Infusion System less vulnerable to hacking so the only option going forward will be to switch to a different infusion system. During the time required to transition to new equipment, the FDA has provided specific steps that can be taken to reduce the risk of unauthorized system access that can be read here.

Root Cause

New study finds that cholera vaccine helps protect community

By Kim Smiley

There are an estimated 3 to 5 million cases of cholera worldwide each year, believed to cause more than 100,000 deaths annually.  Cholera is rare in developed nations, but has been pandemic in Asia, Africa and Latin America for decades.  Researchers continue to search for an effective method to prevent cholera outbreaks.  A recent study found that a cheap oral vaccine is an effective tool to help prevent the spread of cholera.  The vaccine is not a perfect solution, but the study found that when two-thirds of the population was given the vaccine, cholera infections in an urban slum were reduced by nearly 40 percent.

The problem of cholera infections can be analyzed by building a Cause Map.  A Cause Map is a visual root cause analysis that intuitively lays out the cause-and-effect relationships of the multiple causes that contribute to an issue.  A Cause Map is built by asking “why” questions and documenting the answers in cause boxes.  To see how a Cause Map of this issue could be built, click on “Download PDF” above.

So why are so many people infected with cholera each year? Cholera is not generally passed from person to person and is predominantly spread through drinking water contaminated with cholera bacterium.  The feces of an infected individual carry cholera bacterium.  Cholera outbreaks occur in areas where there is a person infected with cholera in a location with poor sanitation infrastructure and inadequate water treatment.

Many efforts to reduce the number of cholera cases have focused on providing clean drinking water and providing sanitization equipment.  A recent study looked at three populations in Bangladesh: one was only given the vaccine, the second was given the vaccine, a hand-washing station and taught how to sterilize drinking water, and no intervention was done on the third population. The results showed that the vaccine alone was nearly as effective at preventing cholera as providing the vaccine along with a hand-washing station and instructions on sterilizing drinking water.  In the study, people were given two doses of the vaccine which costs about $3.70.

In an ideal world everyone would have access to clean, safe drinking water, but the resources required to build the needed infrastructure are not likely to be available any time in the near future.  Having a relatively cheap vaccine that is proven to slow the spread of cholera during an outbreak should prove to be a powerful tool in situations where access to clean water is limited.

Root Cause

U.S. Teen Dies from Plague

By Kim Smiley

Few people think of the plague as a present-day problem, but a teen boy died of the plague on June 8, 2015 in Colorado.  Officials believe he was bitten by a flea carrying the disease on his family’s farm although the exact source of exposure isn’t known. According to the Centers for Disease Control and Prevention, there are an average of seven cases of plague in the United States a year and a small percentage of these cases result in death.

A Cause Map, a visual root cause analysis, can be built to analyze this case and better understand how a patient died of the plague.  The first step in building a Cause Map is to fill in an Outline with the basic background information to define the issue.  The Outline includes a place to list the impacts to the goals resulting from an issue to help define the scope of the problem.  Focusing on the safety goal for this example, a death would be an obvious impact.  Next, “why” questions are used to build the Cause Map.

So why did the teen die from the plague?  There are two causes that contributed to his death; first, he was infected with the plague and second, he wasn’t treated for the plague.  When there are two causes that both contribute to an issue, both are listed vertically on the Cause Map and separated by an “and”.  So why was the patient exposed to the plague?  Officials believe that he was bitten by an infected flea.  The bacteria that causes plague lives in rodents and their fleas.  Investigators haven’t been able to identify which species of rodent was the culprit.

The teen wasn’t treated for plague because it wasn’t identified that he had the plague until it was too late.  All forms of plague can be successfully treated with antibiotics, but the window for treating the illness before it becomes life-threatening can be relatively short and plague can be difficult to identify.  It is suspected that this patient had septicemic plague which occurs when the plague bacteria enter the bloodstream directly.  Septicemic plague is caused by the same bacteria as the more common Bubonic plague, but the symptoms are different and more difficult to identify.  Rather than the telltale presence of swollen, discolored lymph nodes (also known as buboes) caused by the Bubonic plague, the main symptoms of the septicemic plague are fever, chills and abdominal pain which are very similar to the flu and other common illnesses.  In this heart-breaking case, the family of the teen understandably believed he had the flu and he wasn’t treated for the plague in time to prevent his death.

As alarming as this case is, it is important to note that plague cases in the United States are very rare and occur primarily in two regions – northern New Mexico, northern Arizona, and southern Colorado and California, southern Oregon and far western Nevada. If you are planning to enjoy the outdoors in one of these areas, just remember that the best way to prevent plague is to prevent flea bites.

Click on “Download PDF” above to see a Cause Map and Outline for this example.

Root Cause

Contamination found in NIH pharmacy

By Kim Smiley

The National Institutes of Health (NIH) has announced that production of drugs for use in clinical studies has been suspended after fungal contamination was found in two vials of product.  The exact source of the contamination has not been identified, but a recent Food and Drug Administration (FDA) inspection of the facility that prepares the contaminated product found multiple deficiencies, including issues with both the facility and work practices.

This issue can be analyzed by building a Cause Map, a visual root cause analysis that intuitively lays out the cause-and-effect relationships that contribute to an issue. The first step of the Cause Mapping process is to determine how an issue impacted the overall goals.  In this example, the safety goal is impacted because 6 patients were unknowingly given potentially contaminated drugs.  These patients received vials of product from the same batch as the 2 vials found to be contaminated prior to the contamination being identified.  None of the patients have shown signs of illnesses, but they will continue to be monitored. Additionally, the safety goal is impacted because some patients will knowingly be given potentially contaminated drugs.  These patients are due for treatment imminently with no alternative available and the risk of delayed treatment has been determined to be greater than the risk of using the products.  The schedule goal is also impacted as clinical trials are being delayed because the necessary medications aren’t available.

The next step is building the actual Cause Map by starting at one of the impacted goals and asking “why” questions.  So why were the drugs contaminated? It hasn’t been released what specifically lead to the fungal contamination and it may never be known, but the FDA found deficiencies within the facility that could lead to contamination. The inspectors observed workers working with sterile products with protective gear worn inappropriately so that skin and facial hair were exposed.  Issues with the facility itself was also noted, both in the design of sterile work spaces and in the cleanliness of the spaces.  Inspectors determined that the air handling system for the clean rooms wasn’t adequately designed to ensure physical separation from the other spaces.  Additionally, a filter was missing on the air handling system.  The problems with cleanliness of clean rooms included insects found in 2 of 5 clean room ceiling light bays.

The investigation into these issues is ongoing and officials are working to ensure the safety of all products.  As more information becomes available, it can easily be added to the Cause Map.  Once the specific problems with the work processes and facility have been determined, specific solutions can be implemented to address the many issues found by investigators. This problem is one that clearly doesn’t have “one root cause”, but rather many causes that contributed to the problem and more than one solution will be needed to reduce the risk of contamination to an acceptable level.