Tag Archives: bacteria

Root Cause Analysis

Put down the cookie dough

By ThinkReliability Staff

Almost everybody knows that there are potential risks with eating raw cookie dough (or any other raw batter).  However, much of that risk was thought to be due to the potential of salmonella from raw eggs and so, if the plan was to eat, rather than cook, the dough, the eggs could just be left out.  No more! say health experts.  Turns out that just removing the eggs and eating the raw dough may protect you from salmonella, but it still leaves you at risk for E. coli.

A Cause Map, or visual form of root cause analysis, can help demonstrate the risks (or potential impacts) associated with an issue, as well as the causes that lead to those risks.  The process begins by capturing the what, when and where of an incident, as well as the impact to the goals in an Outline.  In this case, the problems being addressed are risk of illness from eating raw cookie dough, as well as a recall associated with contaminated flour.  The when and where are just about everywhere that dough or batter is being made (or eaten).  The safety risks most commonly associated with eating raw cookie dough are salmonella and now E. coli.  The environmental goal is impacted because flour is contaminated with E. coli and the property goal is impacted because of 45 million pounds of flour that have been recalled by the current recall.

Once the impacted goals are captured, they become the first “effects” in the cause-and-effect relationships.  The Cause Map is created by capturing all the causes that led to an effect.  In this case, the risk of contracting salmonella from eating raw cookie dough results from eggs being exposed to salmonella, and the salmonella not being effectively destroyed (by the heat of baking).  The risk of contracting E. coli results from a similar issue.

Cookie dough contains raw flour.  The cooking process kills E. coli (as well as salmonella), meaning cookies and other baked goods are safe to eat, but dough is not.  Distributed raw (uncooked) flour was found to be contaminated with E. coli (leading to the impacted environmental goal and the recall).  The flour was likely contaminated with E. coli while it was still wheat in the field.  Birds and other animals do their business just about wherever they want, and it’s got some bacteria in it, meaning that excrement that falls on wheat fields can deliver contamination to pre-flour.  (Quick side note: we frequently get asked when to stop asking “why” questions.  When you get to an answer that is completely outside your control, like why birds poop in wheat fields, for example, this is a good place to end the cause-and-effect reasoning.)

While flour is processed, the process isn’t designed to completely kill pathogens (unlike pasteurization, for example) and according to Martin Wiedmann, food safety professor at Cornell University, “There’s no treatment to effectively make sure there’s no bacteria in the flour.”  Flour is not designed to be a ready-to-eat product.

Once the causes related to an issue have been developed, the next step is to brainstorm and select solutions.  Unfortunately, health professionals have been clear that they’re not getting far on keeping birds from pooping in fields, nor is there some sort of miracle treatment that will ensure raw flour is safe from disease.  (Scientists underscore that flour isn’t less safe, it’s just that we are becoming more aware of the risks.  Says Wiedmann, “Our food is getting safer, but also our ability to detect problems is getting better.”)  The only way to reduce your risk of getting sick from raw cookie dough is . . . not to eat it at all.  Also, wash your hands whenever you handle flour. (This is of course after you’ve thrown out the floor involved in the recall, which you can find by clicking here.)

To view the Cause Map of the problems associated with raw cookie dough, please click on “Download PDF” above.

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

Study Finds Bacteria Can Live on Airplane Surfaces for Days

By Kim Smiley

With many bodies packed into a tight space and seemingly stale air, airplanes tend to bring out the inner germaphobe in many of us.  And the latest research, especially if you just read the headlines, isn’t going to help. Researchers at the University of Auburn found that Methicillin-resistant Staphylococcus aureus (commonly known as MRSA) and E. Coli can live for days on airplane surfaces.

The experiment involved sterilizing six surfaces found on airplanes (seat pocket, arm rest, leather seat, window shade, tray table and toilet handle), introducing MRSA and E. Coli bacteria to them and then measuring how long the bacteria survived.  Typical conditions inside an airplane were stimulated and the bacteria were suspended in three different solutions (saline, simulated seat and simulated saliva) to replicated the environment inside an airplane. The survival times ranged from 8 to 2 days.  This is a little scary, especially since an estimated 1-2 percent of people in the US may be carriers of these dangerous bacteria.

The good news, and there is good news, is that the surfaces where the bacteria lived the longest, the more porous surfaces such as the seat pocket, are the least likely surfaces to actually spread the contamination.  The study also didn’t look into how much bacteria remained after the typical cleaning  by airlines between flights, but the researchers plan to look into this in the future.

So what can you do to reduce the risk of illness if you have plans to travel on an airplane soon?  The simplest thing you can do to protect yourself is to frequently wash your hands with soap or use hand sanitizer as well as avoid touching your face as much as possible.  If you feel the need to take additional precautions, you can clean the areas around your seat with a disinfectant when you board the plane.

Airline cleaning procedures can also significantly impact the spread of illness.  So the question is, how much do you trust the thoroughness of the cleaning performed by the airline?  I think I may invest in a travel-size hand sanitizer before my next flight.

To see a high level Cause Map of this issue, click on “Download PDF” above.

Root Cause

New Study Finds that Dirty Stethoscopes May Spread Germs

By Kim Smiley

It’s been well documented that washing hands can prevent infections and in the same vein some researchers are now asking questions about potential contamination risks posed by stethoscopes and other small medical equipment used to examine multiple patients. In a recent study, stethoscopes were tested after they were used to examine patients and most were found to have bacteria on them.  Unlike the guidance provided for hand washing, there are currently no guidelines that require physicians to disinfect their stethoscopes between patients.

This issue can be analyzed by building a Cause Map, a visual format for performing a root cause analysis.  In a Cause Map, the causes that contribute to an issue are laid out to show the cause-and-effect relationships to aid in understanding the role the causes played.  The first step in the Cause Mapping process is to fill in an Outline with the basic background information for a problem such as the location and time it occurred.  Additionally, how the issue impacted the organizational goals is documented on the Outline.  The possibility of patient exposure to bacteria is an impact to the safety goal in this example.  Once the impact to the organizational goals is defined, the Cause Map is built by asking “why” questions.

Why is there a risk of patient exposure to bacteria?  This is happening because a contaminated stethoscope may be placed on a patient’s skin.  Stethoscopes are commonly used to listen to a patient’s heart and lungs and they work best when placed directly onto the skin.  Stethoscopes may get contaminated from being used on a person with bacteria on their skin and stethoscopes are not necessarily cleaned between uses.  Stethoscopes aren’t always cleaned between uses because there are currently no guidelines requiring it.  There aren’t any guidelines because it hasn’t been clear if they are needed.  There has been limited research done to understand the issue and determine how much of a risk of illness a contaminated stethoscope may pose, especially if used on healthy skin.

The new study is a good early step in understanding the issue, but it was a relatively small study and a larger scale study may be needed in the future.  The study “Contamination of Stethoscopes and Physicians’ Hands after a Physical Examination” looked at the stethoscopes used by three physicians as they examined a total of 83 patients in a Swiss hospital.  The researchers found bacteria on the stethoscope after 71 of the patient examinations.  It’s also difficult to determine whether bacteria on stethoscopes is responsible for spreading bacteria and whether it has actually caused illness.

The final step in the Cause Mapping process is to come up with solutions that can reduce the risk of the problem recurring in the future.  One good thing about this particular issue is that the solutions are relatively easy and cheap.  Physicians who are concerned about the cleanliness of their stethoscopes can either give them a give clean with disinfectant between patients or use disposable covers that are already commercially available.  Guidelines about cleaning stethoscopes are likely years in the future, but you can always ask your physician about the issue or to clean the stethoscope if you are concerned.

Root Cause

FDA Ruling Questions Safety and Effectiveness of Antibacterial Soaps

By Kim Smiley

The Federal Drug Agency (FDA) has formally questioned the safety and effectiveness of antibacterial soaps with a ruling on December 16, 2013.   Manufacturers of antibacterial soaps have one year to provide data that proves that anti-bacterial soaps are both safe and more effective than regular soap and water. Any antibacterial products that have not provided sufficient data to satisfy regulators by late 2016 would have to be reformulated, relabeled or removed from the market.

This issue can be analyzed by building a Cause Map, or visual root cause analysis.  A Cause Map visually lays out the many causes that contribute to an incident to intuitively show the cause-and-effect relationships.  When starting the Cause Mapping process, the first step is to fill in an Outline. The Outline documents the basic background information as well as lists how the issue impacts the goals.

In this example, there are a number of impacts to the goals worth considering.  The potential financial impacts are certainly significant.   It is estimated that it will cost companies between $112 million and $368 million to comply with the new regulations.  The safety goal is also a key component of this issue since safety concerns are one of the driving factors for the new push for additional data.

The FDA is concerned about the safety of antibacterial soaps because many contain triclosan and other similar chemicals.  Studies using lab animals have found that triclosan can disrupt hormones, such as sex hormones and thyroid hormones.  Interference with the body’s natural hormone levels can have a huge impact on how the body functions, especially in children who are still growing.  Use of antibacterial agents has also been associated with an increase in allergies, although more data would be needed before a definitive link could be established.  Use of antibacterial products may also lead to increased resistance to antibiotics which is an issue generating increasing concern.

In addition to questions about safety, there are also questions about the effectiveness of the products.  Microbiologists at the FDA have stated that there is currently no evidence that use of over-the-counter antibacterial soap is any more effective at illness prevention than simply washing with soap and water.  Consumers buying the products assume that they are getting some sort of additional protection against illness, but that doesn’t appear to be the case.  It is also worth noting that viruses are the most common cause of infection in the United States and antibacterial products are powerless against them.

The bottom line appears to be that antibacterial soaps are more expensive, have potential risks associated with them and aren’t better at preventing illness.   Manufacturers will have the opportunities to present data about their products to the FDA, but I expect that there will be some significant changes to antibacterial products in the future.

The current ruling does not apply to hand sanitizers which are typically alcohol based so don’t be afraid of using sanitizer if hand washing is unavailable.  Also, studies have proven triclosan is effective at fighting gingivitis in toothpaste.  This current ruling only applies to personal hygiene products (like hand soap), but I suspect this is just the first of many hard questions for the billion dollar anti-bacterial product industry.

To view the Outline and Cause Map, please click “Download PDF” above.

Root Cause

Increase in Resistant Bacteria and Fungus Threatens Public Health

By ThinkReliability Staff

On September 16, 2013, the Centers for Disease Control and Prevention (CDC) issued a report “Antibiotic Resistance Threats in the United States, 2013”.  This report detailed the impacts, causes and recommended solutions related to antibiotic resistance within the US (although the concerns are similar worldwide).

The report takes the form of an incident investigation.  Specifically, the report addresses the impacts to the goals of the CDC, the cause-and-effect relationships resulting in these impacts, and what is recommended to reduce the risk of these impacts continuing. The information presented in their report can be captured in a Cause Map, or visual root cause analysis, which allows a demonstration of the interaction of the various causes presented in the report.

The report begins with the goals being impacted by the problem of antibiotic resistance.  Specifically, the CDC conservatively estimates that more than 2 million people are sickened in the US every year by antibiotic-resistant infections.  More than 23,000 are estimated to die as a result.  The risk is not just for the general public, but healthcare providers as well, who are implicated in the report as having resistant strains on their hands, which causes a health risk for them as well as patients.  The report identifies not only person-to-person spreading of infection, but also spreading from environmental causes, such as food.  The presence of these strains impacts the environmental goal as well.

The cost of these infections is staggering.  It is estimated that up to $20 billion per year is spent on direct excess healthcare costs as a result of these infections in the US alone.  The productivity cost (loss of productivity across industries due to employees being out sick) is estimated to be as high as $35 billion per year.  (While the causes discussed in the report are of concern globally, the impacts to the population are specific to the US.)

Increased illness from resistant infections results from exposure to resistant infections, decreased protection from infection, and a shortage of drugs available to treat these infections.  Exposure to antibiotic-resistant infections results from either person-to-person or environmental spread.  Spread can pass from anybody who has antibiotic resistant bacteria or fungus, but a primary source is healthcare providers, who can easily pass the infection with improper hand washing (or none at all).  Environmental causes include surfaces (again, healthcare providers are a frequent source here) but also food.  Food animals are given antibiotics to control disease, but also sometimes are given antibiotics without a diagnosis to prevent infection or promote growth.  These antibiotics kill off non-resistant bacteria but not resistant bacteria, which remains in the meat and feces.  If meat is improperly cooked, the bacteria can be passed on to humans.  But the issue is not just with improperly cooked meat.  Other foods can be contaminated with animal feces, which can also contain the resistant bacteria.

When a person is taking antibiotics, they have a decreased protection from infection.  This is because antibiotics kill all bacteria – including “good” bacteria that helps prevent infection.  While antibiotics are used to treat disease,  the CDC estimates that 50% of prescriptions are unnecessary or not optimally effective.  The use of antibiotics has been identified as the single most important factor leading to antibiotic resistance.

The increase of antibiotic-resistant bacteria (and fungi) means that more and more drugs are becoming ineffective in treating these infections, increasing the risk of death when infections occur.  Additionally, research and development into antibiotics is slowing, compounding the problem of effective drug availability.

As part of the report, the CDC provides wide-ranging recommendations to limit antibiotic-resistant infections.  The recommendations are for healthcare providers, communities and individuals.  They aim to first prevent the spread of infection by ensuring that antibiotics are prescribed and used properly, as well as by better tracking the spread of antibiotic resistant pathogens.  This includes stopping the use of antibiotics in feed animals for growth promotion.  Additionally, better cleanliness control for healthcare providers, food preparers and the general population will reduce the spread of disease.  Secondly, the CDC aims to provide better treatment for these infections by investing in research and development to provide new antibiotic treatment options.  It is also hoped that surveillance data can provide more effective diagnostic tools and use of the treatments currently available.

To view the Outline and Cause Map, please click “Download PDF” above.

Want to learn more?
Read the CDC report.
Read our previous blog on Carbapenem-Resistant Enterobacteriacae (one of the “Urgent” threats identified in the CDC report).

Root Cause

Cases of Deadly ‘Superbugs’ on the Rise in US

By Kim Smiley

A new antibiotic resistant strain of bacteria is causing deaths and raising flags in US healthcare facilities. The bacteria is called Carbapenem-Resistant Enterobacteriaceae, often shortened to CRE, and is named for its ability to resist carbapenem antibiotics, the last resort treatment for antibiotic resistant bacteria. The fatality rate for those infected may be as high as 50 percent. In 2012, 4 percent of hospitals reported cases of CRE, up from about 1 percent a decade ago. The situation at long-term care hospitals is significantly worse, with 18 percent reporting cases last year.

The issue of CRE can be analyzed by building a Cause Map, a visual method for performing a root cause analysis. The first step is to create an Outline that documents all the background information for an issue. How the problem impacts the overall organization goals is also listed on the bottom of the Outline. In this example, the safety goal is obviously impacted since there have been patient deaths. After the Outline is completed, the second step is to build the Cause Map. The Cause Map is built by asking “why” questions to determine what causes contributed to the issue and then arranging the causes visually to show cause-and-effect relationships. Why have there been patient deaths?  This has occurred because they were infected with CRE and CRE infections are dangerous.

People are being exposed to CRE primarily in healthcare settings. CRE is being passed between patients within the same facility and between healthcare facilities as infected patients are transferred to different healthcare settings. Exposure is occurring between patients because infected patients may not be identified or adequately isolated. Many healthcare facilities do not have the capability to test for CRE and it’s also difficult to identify who should be tested since some patients who carry the bacteria are not symptomatic. CRE also tends to infect individuals who have other health issues and weakened immune systems. Treatment of the other issues may involve invasive medical devices, such as catheters, that can provide a pathway for infection into the body.

CRE infections are dangerous because they have a high rate of fatality, up to 50 percent according to the CDC, and they are difficult to treat. CRE are resistant to virtually all antibiotics. This strain of bacteria is also particularly worrying because they can transfer their resistance to other bacteria within their family, compounding the problem. Antibiotic resistant bacteria have developed over the years because of the wide use of antibiotics. Each time antibiotics are used, bacteria have a chance to evolve and they have over the years.

The final step in the Cause Mapping process is to find solutions that would reduce the risk of the problem in the future. In this example, there isn’t an easy solution. There are no promising new antibiotics in development at this time that would likely be able to treat CRE infections so the best hope is to prevent the bacteria from spreading. The CDC has recommended steps such as identifying and isolating infected patients.

This example also show important it is to track the effectiveness of solutions after they are implemented because there can be unintended consequences that show up later on. Antibiotics have saved thousands of lives, but they are becoming less effective as bacteria develop resistance to them. New solutions will be needed to prevent or fight these types of infections in the future. Cause Mapping is a useful tool to document evolving issues because they can easily be adjusted and added to as new information is available.

To view a high level Cause Map, click on “Download PDF” above.

Root Cause Analysis

Bacterial Contamination of Tampons

By ThinkReliability Staff

On November 9, 2011, the FDA announced a recall of a certain subset of tampons for contamination with the bacteria Enterobacter sakazakii.  The recall is for certain products delivered to certain stores, mainly in the central U.S. Region.  For a full list of the product  recalls, check the FDA recall site.

The specific source of the contaminant has not been identified.  Investigations of previous instances of contamination with the Enterobacter sakazakii have had difficulty determining an exact source, as this bacteria is found within human  and animal guts.  However, even with limited information, we can begin a Cause Map, or visual root cause analysis, which allows us to view the areas where more data collection is needed in order to gather evidence to complete the analysis.

We begin by capturing the basic information about the incident as well as the impacts to the goals.  The safety goal is impacted due to the risk of infection from the contamination tampons.  The environmental and customer service goals are impacted because a product was bacterially contaminated.  Additionally, the product recall impacts the production, property and labor goals.  We begin our Cause Map with the impacts to the goals.

Both the risk for infection and the product recall were caused by the bacterial contamination of a product.  The product was contaminated because contaminated raw material was used for its manufacture.  This occurred both because the raw material was contaminated and because the quality control or testing process for the raw material was insufficient.  Whether there was no testing process for the given bacteria or whether the process did not recognize the bacteria and stop the use of the contaminated raw material is unclear.

At this point, because the source of the raw material contamination is unknown, an open question which requires evidence-gathering is “how did the raw material get contaminated”? This will require cooperation from the raw material manufacturer.   The other necessary information is to do a detailed review of the quality control and/or testing that is used on raw materials prior to manufacturing and determine how the contaminated material was able to be used to make a final product.  Once this process is looked at in detail, specific solutions that would prevent a recurrence of this type of contamination can be implemented.

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

Root Cause Analysis

Contaminated Cantaloupes Cause Deaths

By Kim Smiley

The number of food recalls in the news lately is enough to make you lose your appetite.

Let’s start by focusing on just one of the recent recalls.  Listeria from contaminated cantaloupe has caused at least 15 deaths and has sickened more than 80 across the USA.  Tests have traced the listeria back to a single farm in Colorado, but the source has not yet been identified.

Listeria is a common, but potentially deadly bacteria that can be found in soil, water, decaying plant matter and manure so the potential sources are numerous.  Another important piece of information is that Listeria can be difficult to eliminate once it has spread to distribution and processing facilities because it grows well at low temperatures, unlike most bacteria.  Listeria can continue to grow in refrigerated areas where fruit maybe stored or processed.

Finding the source of a listeria outbreak can also be difficult because it can take up to two months for an individual to become sick.  Adding to the complexity of identifying what food is causing an outbreak of listeria is the wide variety of foods that can become contaminated.  Listeria can be found in meat, dairy, fruits and vegetables.

Even once the source of contamination has been identified, it can be difficult to effectively remove the item from the food supply.  In this example, the sheer number of cantaloupes involved as well as a long supply chain made it difficult to remove all contaminated melons.  The farm recalled their entire 2011 cantaloupe crop which was more than 300,000 cases distributed from the end of July to mid-September.  The cantaloupes were shipped to 25 states and sold through many different retailers.

A recent article by CBS stated that the average cantaloupe makes four or five stops on the way to the super market shelves.  Typical cantaloupes will go to a packing house for cleaning and packing, a distributors, a retail distribution center and finally a grocery store before they make it to the consumer.   This makes it very difficult to identify where a food might have been contaminated.

Click on “Download PDF’ above to view a high level Cause Map of this issue.  A Cause Map is an intuitive form of root cause analysis that visually lays out the causes that contribute to an issue.

Root Cause Analysis

Contaminated IV Bags Sicken 19

By Kim Smiley

With the aid of the State Health Department and the Centers for Disease Control and Prevention (CDC), six hospitals have traced back recent patient infections to contamination in total parenteral nutrition (TNP) delivered via intravenous (IV) bags.

Although the first infection occurred in January, 2011, a pattern was not established until March, 2011, after nineteen patients were infected with serratia marcescens bacteria.  Patient infection is an impact to the patient safety goal.

The infections occurred as a result of the patients being given contaminated product – in this case, the IV bags.  The bags were recalled, and are no longer in production.  Ten of the patients died.  Investigators have said they won’t be able to determine whether the infection caused the deaths because the patients were already very ill (TNP is used for patients who are too ill to eat on their own).

The IV bags were compounded at a local pharmacy.  There was a potential for contamination in the raw material used for compounding, during the compounding at the pharmacy, or at the hospital.  Because six different hospitals experienced the same rare bacterial contamination, it is unlikely that the contamination occurred at the hospital.

According to Dr. Alexander J. Kallen, a medical officer with the Centers for Disease Control and Prevention, “Historically, what we’ve seen is a breakdown in the manufacturing process.”  The investigation is underway to determine if the contamination was caused by an issue with the manufacturing process, an issue with the sterility of equipment, or a contamination of the raw material.  As the investigation continues, more detail can be added to the Cause Map.  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.

While investigating an issue, it can also be helpful to look at the process for identifying and isolating issues, and implementing improvements.  In this case, after patients receive or use products, they are monitored for certain reactions.  If those reactions occur (such as those that indicate a bacterial infection), they are reported to the State Health Department, then the CDC.  The CDC investigates to determine the source of the infection and then pulls the affected products off the market.  Currently, the CDC has identified the product that is contaminated, though not the source of the contamination.

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.  To view the Cause and Process maps, click “Download PDF” above.