Tag Archives: outbreak

Root Cause Analysis

Chipotle Improves Food Safety Processes After Outbreaks

By ThinkReliability Staff

On February 8, all Chipotle stores will close in order for employees to learn how to better safeguard against food safety issues.  This is just one step of many being taken after a string of outbreaks affected Chipotle restaurants across the United States in 2015.  Three E. coli outbreaks (in Seattle in July, across 9 states in October and November, and in Kansas and Oklahoma in December) sickened more than 50 customers.  There were also 2 (unrelated) norovirus outbreaks (in California in August and Boston in December) and a salmonella outbreak in Minnesota from August through September.

In addition to customers being sickened, the impacts to the company have been severe.  The outbreaks have resulted in significant negative publicity, reducing Chipotle’s share price by at least 40% and same-store sales by 30% in December.  Food from the restaurants impacted by the fall E. coli outbreak was disposed of during voluntary closings, and the company has invested in significant testing and food safety expertise.

E. coli typically sickens restaurant customers who are served food contaminated with E. coli. Food ingredients can enter the supply chain contaminated (such as the 2011 E. coli outbreak due to contaminated sprouts), or be contaminated during preparation, either from contact with a contaminated surface or a person infected with E. coli. While testing hasn’t found any contamination on any surfaces in the affected restaurants or any employees infected with E. coli, it hasn’t been able to find any contaminated food products either. While this is not uncommon (the source for the listeria outbreak that resulted in the recall of ice cream products has not yet been definitively determined), it does require more extensive solutions to ensure that any potential sources of contamination are eliminated.

Performing an investigation with potential, rather than known causes, can still lead to solutions that will reduce the risk of a similar incident recurring.  Potential or known causes can be determined with the use of a Cause Map, a visual form of root cause analysis.  To create a Cause Map, begin with an impacted goal and ask “Why” questions to determine cause-and-effect relationships.  In this case, the safety goal was impacted because people got sick from an E. coli outbreak.  A contaminated ingredient was served to customers.  This means the ingredient either entered the supply chain contaminated or it was contaminated during preparation, as discussed above.  In order for a contaminated ingredient to enter the supply chain, it has to be contaminated with E. coli, and not be tested for E. coli.  Testing all raw ingredients isn’t practical.

Chipotle is instituting solutions that will address all potential causes of the outbreak.  Weekly and quarterly audits, as well as external assessments will increase oversight.  Cilantro will be added to hot rice to decrease the presence of microbes.  The all-employee meeting on February 8 will cover food safety, including new sanitation procedures that will be used going forward.  The supply chain department is working with suppliers to increase sampling and testing of ingredients.  Certain raw ingredients that are difficult to test individually (such as tomatoes) will be washed, diced, and then tested in a centralized prep kitchen and shipped to individual restaurants.  Other fresh produce items delivered to restaurants (like onions) will be blanched (submerged in boiling water for 3-5 seconds) for sanitation prior to being prepared.

Chipotle has released a statement describing their efforts: “In the wake of recent food safety-related incidents at a number of Chipotle restaurants, we have taken aggressive actions to implement pioneering food safety practices. We have carefully examined our operations—from the farms that produce our ingredients, to the partners that deliver them to our restaurants, to the cooking techniques used by our restaurant crews—and determined the steps necessary to make the food served at Chipotle as safe as possible.”  It is hoped that the actions being implemented will result in the delivery of safe food, with no outbreaks, in 2016.

To view the impacts to the goals, timeline of outbreaks, analysis, and solutions, please click on “Download PDF” above.  Or click here to learn more.

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

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

Multiple Potential Causes for Avian Flu Outbreak

By ThinkReliability Staff

An outbreak of avian influenza (flu) H5N2 centered around Iowa in the United States has resulted in nearly 47 million birds being killed in 21 states. There is a low risk that this outbreak could spread to humans as the 1996 avian flu did. The impacts on the poultry industry have been significant: the number of birds being killed has led to an increase in poultry prices. Says Phil Lempert, “We’ve lost 10 to 13 percent of the laying hens in this country, so we’re going to have this period of time where we have less birds and less eggs. That means higher prices.”

The financial impact isn’t limited to consumers. The United States Department of Agriculture (USDA) estimates it will spend more than $500 million fighting the outbreak. The impact on poultry producers is expected to be even higher. The USDA Animal and Plant Health Inspection Service (APHIS) is studying the outbreak and attempting to put into place measures that will reduce the spread of the outbreak. Finding the causes leading to the outbreak has proven to be challenging.

We can capture the information that is known in cause-and-effect relationships using a Cause Map to better understand what caused this outbreak. The first step in the Cause Mapping process is to fill in an Outline with basic background information, which includes listing how the overall goals are impacted by the issue. The Cause Map is than built by asking “why” questions to lay out the cause-and-effect relationships. In this example, the animal safety goal is impacted due to the deaths of nearly 47 million birds. These birds were killed because of an outbreak of avian flu. An outbreak results from an initial infection (believed to have been transmitted in this case to domestic flocks by wild birds) and the spread of the disease. Based on genetic analyses from APHIS, this outbreak appears to have multiple independent introductions within the outbreak area (i.e. the transmission from wild birds to domestic flocks happened in multiple locations).

According to their Epidemiologic and Other Analysis of HPAI-Affected Poultry Flocks: June 15, 2015 Report: “APHIS concludes that at present, there is not substantial or significant enough evidence to point to a specific pathway or pathways for the current spread of the virus. We have collected data on the characteristics and biosecurity measures of infected farms and studied wind and airborne viruses as possible causes of viral spread, and conducted a genetic analysis of the viruses detected in the United States.” This means that the cause or causes of the spread of the avian flu cannot be definitively determined due to lack of evidence. When an investigation has a lack of evidence, potential causes are included in the analysis with a question mark, indicating insufficient evidence.

In this case, avian flu was potentially spread by air, by wild birds, and by human movement. Data from APHIS research indicates that the virus has been able to spread on windy days up to a half mile. A solution under consideration is more advanced ventilation systems for poultry farms that would prevent transmission of disease from farm to farm. Previous outbreaks have indicated that wild birds can not only cause an initial infection, but can continue to spread the disease from flock to flock. This evidence supports this cause, but is not strong enough to rule out other causes so all should still be included on the Cause Map. Lastly, APHIS found inadequate biosecurity (primarily cleaning and disinfecting) measures on equipment and personnel that traveled from farm to farm, which could also potentially spread the disease.

The issues found with biosecurity are a particular concern. Says Michael T. Osterholm, the director of the Center for Infectious Disease Research and Policy at the University of Minnesota, “We used to think we had outstanding biosecurity in poultry. But, except for the outbreak in 1983, which was stopped quickly, we have never been tested before.”

Osterholm and other researchers say more research is needed to screen for viruses, and develop drugs and vaccines to ensure public safety. Although the virus has not yet been shown to infect humans, the Centers for Disease Control and Prevention has developed interim guidelines on testing and treatment. APHIS continues research on how to limit the spread and the USDA, in order to offer some relief on prices, has recently allowed poultry imports from the Netherlands.

To view a Cause Map, or root cause analysis presented in a visual cause-and-effect diagram, of the ongoing outbreak, please click “Download PDF” above.

Root Cause

Duodenoscope Superbug Outbreak: What You Need to Know

By ThinkReliability Staff

The bacteria involved in the outbreak are deadly: The recent outbreak in California involves Carbapenem-resistant Enterobacteriaceae (CRE). According to Centers for Disease Control and Prevention (CDC) Director Tom Frieden, “CRE are nightmare bacteria. Our strongest antibiotics don’t work and patients are left with potentially untreatable infections.” About 50% of patients with a CRE bloodstream infection will die. At least 7 people were infected at the UCLA Medical Center from October 2014 to January 2015, two of whom died.

Duodenoscopes are frequently used: Duodenoscopes are thin flexible scopes with a light and miniature camera attached, used in endoscopic retrograde cholangiopancreatography (ERCP) procedures to diagnose and treat liver, pancreas and bile-duct problems. The FDA hasn’t recalled the scopes because, according to US Food and Drug Administration (FDA) spokeswoman Leslie Wooldridge, “The FDA feels that the lifesaving nature of ERCP, performed on more than 500,000 patients annually in the U.S., makes it important for these devices to remain available.”

Duodenoscopes have been causing problems with infection for a long time: The President of the American Gastroenterological Association, John Allen, M.D. says that duodenoscopes have been causing superbug infections since 1987. He says, “It certainly is disturbing that a fundamental design issue with these scopes would cause problems for this long.” 16 patients developed serious infections after the use of a duodenoscope in France in 2008-2009, as reported in the journal Endoscopy. A 2013 outbreak infected 39 patients in Chicago (after which a duodenscope was destroyed because decontamination efforts were unsuccessful). The FDA received 75 reports involving 135 patients related to duodenoscope contamination from 2013 to 2014. 18 patients in North Carolina have been infected by CRE from duodenoscopes so far this year (2 of those patients have died).

Cleaning duodenoscopes is really difficult: The two duodenoscopes found to have been infected in the California outbreak were “sterilized according to the manufacturer’s specifications”, says the medical center. The FDA issued a warning February 19, 2015, noting that “Recent medical publications and adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly. Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it.” Effectively, even following the instructions may not fully sterilize the duodenoscope.

The FDA is working on label changes for duodenoscopes: According to Dr. William Maisel, chief scientist for the FDA’s Center for Devices and Radiological Health, “We are working to expedite modifications to the label. We are also talking about updating the risk information.” The FDA recommends that hospitals “consider taking a duodenoscope out of service until it has been verified to be free of pathogens if a patient develops an infection with a multidrug-resistant organism following ERCP, and you suspect that there may be a link between the duodenoscope and the infection.” The FDA has also asked duodenoscope manufacturers to prove that their recommended methods provide adequate disinfection.

Some worry that may not be enough: Says Mary Logan, chief executive of the Association for the Advancement of Medical Instrumentation, “the devices need to be designed better, the instructions need to be more clear, the hospitals need better training, and adequate time needs to be given in hospitals to ensure sterility is top notch.” The CDC is working with duodenoscope manufacturers on a reprocessing (cleaning and sterilizing for reuse) protocol for the instruments. In the meantime, the UCLA Medical Center has turned to gas sterilization and has reported no new infections since the switch. However, the procedure is highly toxic and poses a risk to staff and patients. The FDA says it is “not something that we routinely recommend”.   Hospitals in North Carolina are screening patients for CRE and isolating infected patients, as well as decontaminating their rooms after they’re released. They’ve also enhanced the cleaning and sterilization processes for duodenoscopes.   At least one hospital is quarantining each device for 48 hours to verify by culture that it’s free of CRE and other infections.

It’s all part of a much bigger problem: Some worry that the time and money being spent dealing with the real, though comparatively small, risk of infection from contaminated duodenoscopes takes away from the broader effort of preventing all hospital infections, especially those that are resistant to antibiotics. The CDC has determined that about 1 in 25 patients acquire a hospital-acquired infection during a hospital stay (see our previous blog on this issue). Says David Ropeik, a consultant in risk perception and communication, the concern over this issue is “going to flare up and then it’s going to go away” but “the world will still be at serious peril from a risk we don’t take seriously, which is antibiotic resistance. Germs are figuring out how to resist our antibiotics faster than we can make new ones.”

If you would like to learn more, attend our FREE webinar “Healthcare Case Study – Hospital-Acquired Infections” on Thursday, March 5, 2015 at 11 am EST.  Register here.

Root Cause

The Disneyland Measles Outbreak: What you Need to Know

By ThinkReliability Staff

About 100 people, including 5 Disney theme park employees, have been infected with measles after an outbreak centering around the Disney theme parks in California. According to Disney, those 5 employees have returned to work, along with other exposed employees who have proved immunity against the disease. Because the Disney theme parts are so popular with people all over the world, measles has now been found in at least 10 other counties and 5 other states in the U.S. Says Dr. James Cherry, pediatric infectious diseases expert at UCLA, “Disneyland – this is the ideal scenario. This is sort of the perfect storm. People go to Disneyland, and they went from all different counties and all different states.”

Why measles, and why now?

According to Dr. Anthony Fauci, the Director of the National Institute of Allergy and Infectious Diseases, there were an average of 88 cases a year of measles between 2001 and 2013. (Measles was declared eliminated in the US in 2000.) In 2014, there were 644 cases in 23 separate outbreaks.   Although measles is eliminated in the US, “Travelers to areas where measles is endemic can bring measles back to the US, resulting in limited domestic transmission of measles,” according to a California Department of Public Health statement.

Once measles has entered an area, it can spread quickly. Says Matt Zahn, Orange County Health Care Agency medical director, “Measles spreads very easily by air and by direct contact. Simply being in the same room with someone who has measles is sufficient to become infected.” The Centers for Disease Control and Prevention (CDC) says “Measles is so contagious, that if one person has it, 90% of the people close to that person who are not immune will also become infected.” Additionally, the measles virus can remain “active and contagious on infected surfaces for up to 2 hours,” says the CDC. That 90% makes measles “one of the most infectious or transmissible viruses that we’re aware of,” says a Cody Meissner, a professor of pediatrics at Tufts University School of Medicine.

Decreasing vaccination levels in Orange County, where the outbreak is centered, are fueling the spread of the disease. In 2006, 95% of California kindergartners were fully vaccinated for measles. Now, only 92.6% are. Local officials say the outbreak involves a significant number of people who were not immunized, either by choice or because they are too young (measles vaccines are administered starting at 12 months old) or who have other health issues precluding vaccination.

Vaccination rates of the MMR vaccine (which includes immunization against measles) have been dropping, due to increasing concerns about side effects from vaccines and decreasing concerns about the disease itself. (Click here to read our previous blog about this issue.) Says Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, “The development of the measles vaccination and the elimination of measles from this country several years ago, until it bounced back no with these outbreaks, was really a triumph in medical public health endeavor. Good vaccinations, in some respects paradoxically, are victims of their own success. Now that we don’t see a lot of measles, the scare of the difficulty and the seriousness of it is not on people’s radar screen. It gets back on their radar screen when you see what is going on right now throughout the country, which could be completely avoidable if people had vaccinated their children.”

Who is at risk?

According to Orange County Health Agency Spokesperson Deanne Thompson, “It is at large in the community now, and particularly infants too young to be immunized, people with other health conditions and, of course, people who aren’t immunized need to be very concerned. [They] really should rethink that and consider getting vaccinated.”

Anyone who has not been vaccinated for measles is particularly at risk, and California state officials have warned those who have not been vaccinated or are otherwise immune to measles to stay away from the theme parks. It is possible that those who have received the vaccine can also get the disease, though it is far less likely.

What should you do?

“The best way to prevent measles and its spread is to get vaccinated,” says Dr. Ron Chapman, director of California Department of Public Health. If that isn’t possible, at this point, it is recommended to stay away from the Disney theme parks in California until the outbreak is over. If you are taking your baby out of the country, the CDC recommends vaccination at 6 months for measles. If your child does get the measles, keep in mind that’s it not something that doctors today have seen frequently, or possibly at all. The CDC is making an effort to educate physicians. Says Jane Seward, the deputy director of the Division of Viral Diseases for the CDC, “We’ve really tried to hammer home the message that if you see somebody with a febrile rash illness, ask them if they’ve gone overseas, ask them about measles in their community, and ask them about their vaccination status. Think of measles.”

To view a Cause Map, a visual root cause analysis, of this outbreak, click on “Download PDF” above.  To learn more about this issue, click here.

Root Cause

Ebola Outbreak Claiming Lives of Medical Staff

By ThinkReliability Staff

On July 29, 2014, the ongoing Ebola epidemic in west Africa was hit a hard blow when Dr. Sheik Humarr Khan, a leading doctor who treated Ebola patients and  national hero in Sierra Leone, died from the deadly virus.  The outbreak, which began this spring, has now infected thousands and killed nearly 900 people across Sierra Leone, Liberia, Guinea and Nigeria, including more than 90 healthcare workers who were treating victims.  It’s the most widespread and deadliest yet, due to the relative ease of travel and an apparently new strain of the disease.  (Read our previous blog about the outbreak.)

Because of the deadly and quick-spreading nature of the Ebola virus, many precautions are taken to protect healthcare workers from the disease.  Says Marie-Christine Ferir, the Emergency Coordinator of Médecins Sans Frontières/ Doctors Without Borders, “As well as the personal protective equipment that our staff wears, we have a series of strict procedures and protocols.  Our treatment centers are designed to ensure the safest possible working environment for our staff.”  Adds Dr. Tom Frieden, the Director of The Centers for Disease Control and Prevention (CDC), “We work actively to educate American health-care workers on how to isolate patients and how to protect themselves against infection.”

Yet workers are still getting sick – and dying.  In an interview with Armand Sprecher, the medical advisor to Doctors Without Borders, he noted that, though the suits worn by healthcare workers when dealing with infected patients are impervious to fluid, procedures and protocols still have to be followed.  For example, wearing or taking off the suit improperly can cause fluid transfer to the face, or hands, which then may touch the face.  An accidental needle stick can also result in a transfer of fluids that can lead to infection.

Now people in other countries are concerned Ebola may spread further.   In order to give stricken healthcare workers the best shot possible, they are generally returned to their home countries for treatment, raising concerns that their presence will allow the virus to take root there.  An American doctor and nurse were returned to the United States for treatment on August 2nd and August 4th, respectively.  Officials note that every precaution is being taken to isolate the patients and that Ebola can be spread only by bodily fluids, which requires very close contact.

Though there are no vaccines or currently approved treatment for Ebola, the infected American personnel received experimental treatment while still in Liberia. The treatment attempts to use antibodies produced by animals exposed to Ebola to help the immune system fight off the virus.  Dr. Brantly received a blood transfusion from a boy who survived Ebola under his care (surviving Ebola appears to provide immunity against re-infection).  Both vaccines and treatments are in development, but funding is difficult given the relative rarity of Ebola.

In the ongoing attempt to contain the spread of the virus, Sierra Leone has quarantined neighborhoods, cancelled public meetings and overseas trips, while Liberia has closed schools, most borders, and put state employees on leave.  The CDC has issued a Level 3 Travel Warning to Guinea, Liberia and Sierra Leone.  The World Health Organization has launched a $100 million campaign with the aim of bringing the epidemic under control, partially by providing new doctors.

To view the impacts this disease is having on the public as well as healthcare professionals, the causes of these impacts and what is being done to reduce the risk of these impacts, please click on “Download PDF” above.  Or read our previous blog to learn more about the outbreak.

 

Root Cause

5.5 Million Cases of Norovirus are Spread Via Food Each Year

By Kim Smiley

Norovirus outbreaks on cruise ships may make exciting headlines, but the reality is that only one percent of norovirus outbreaks occur on the high seas.  About 20 million people in the US are sickened by noroviruses in the US each year and one of the most common transmission paths is via food.  Food-borne norovirus is estimated to be responsible for 5.5 million cases of norovirus annually in the US.

A Cause Map, a visual method for performing a root cause analysis, can be used to analyze this issue.  The first step in the Cause Mapping process is to determine how an issue impacts the overall goals and then the Cause Map is built by asking “why” questions to visually lay out the cause-and-effect relationships.  In this example, we’ll focus on the safety goal since it is clearly impacted by 5.5 million cases of norovirus transmitted via food.

So why are people getting norovirus from food?  This is happening because they are consuming contaminated food, predominantly at restaurants or catered events.  The food becomes contaminated when a food worker’s hands are contaminated by norovirus and they touch food, particularly food that is ready to serve and won’t be cooked prior to consumption.  (Disclaimer: You may want to stop reading here if you are eating or thinking about going to out to eat soon.)

For those unfamiliar with the illness, norovirus is basically a gastrointestinal nightmare that can cause the human body to do very messy things.  If a food service worker is ill, the virus can get on their hands, especially after using the bathroom.  According to a Centers for Disease Control and Prevention (CDC) report, the transmission of food-borne norovirus is “primarily via the fecal-oral route.”  And that is more than enough said about that.

It is also worth asking why food workers are at work if they are under the weather.  In the US, few food service workers get paid sick leave so they may show up at work sick because they are concerned about the loss of income and the impact on their jobs.  It’s also important to ensure that workers understand the importance of good hygiene and have access to both water and soap and time to effectively wash their hands.

The final step in the Cause Mapping process is to develop solutions to reduce the risk of the problem recurring.  The solutions to this problem are both simple in concept and difficult to effectively implement.  Ideally, food workers should stay home when they are ill and for at least 48 hours afterwards, but this is much easier said than done for many people.  Food workers should also wash their hands after using the bathroom and before handling any food, but it can be difficult to enforce the policy because employers and managers aren’t (and shouldn’t be) closely monitoring what happens during bathroom breaks.

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

Root Cause

Students Will Receive a Meningitis Vaccine Not Yet Approved in the US

By ThinkReliability Staff

In an unusual move, on November 16, 2013 the US Food and Drug Administration (FDA) approved the importation and use of a vaccine not yet approved in the US to attempt to minimize the spread of a rarer – and more difficult to prevent – strain of meningitis on a college campus.

Information about the outbreak, including the effects, causes, and recommended solutions, can be captured in a Cause Map, or visual form of root cause analysis.  This method of problem-solving begins by capturing the background information on the event, then determining the impact of the event on the organization’s goals.

The outbreak began at Princeton University in March of this year.  Meningitis outbreaks can be more common at college campuses because of the close living quarters.  The specific strain involved is known as serogroup, or type B, which has been more difficult to create a vaccine against because the coating on the bacteria is different than that from other types, for which a vaccine was developed in 2005.  Since that vaccine, the number of cases of meningitis on college campuses has declined, though there were 160 cases of B strain meningitis in the US last year.  (In the US, B strain is rarer than other types.)  This is the first outbreak of B strain meningitis in the world since the vaccine was approved.

This outbreak has impacted the safety goal, as the potential for serious injuries and fatalities is high.  The spread of meningitis can be considered an impact to the environmental goal, and the customer service goal is impacted by students being sickened by meningitis.  Treatment and vaccination are an impact to the labor/time goal.

Beginning with the impacted goals and asking “why” questions develops the cause-and-effect relationships related to the incident.  In this case, the outbreak resulted from the spread of meningitis due to coughing or contact among the close quarters common on a college campus, and the fact that students were not vaccinated against this particular strain of meningitis.  A vaccine for the B strain of meningitis has not yet been approved in the US as it was recently developed, although it was approved for use in Europe and Australia earlier this year.  Developing a vaccine for the B strain was difficult (it took over 20 years) because of the differences in bacteria coating from other strains.

Though the vaccine has not been approved for general use in the US, the FDA and Princeton University officials determined that the prevention benefits outweigh the risk of its use.  Specifically, students at Princeton will be offered two doses of the vaccine, paid for by the university.  The vaccines are not mandatory.  In addition, students are being reminded to wash their hands, cover their mouths while coughing, and not to share personal items.  It’s also hoped that holiday travels will end the outbreak as students disperse, though it’s also possible that the travel could spread the disease, though this is considered highly unlikely by health officials.   Time will tell if these actions are adequate to stop the spread on campus.

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