Tag Archives: contamination

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 Analysis

NIH suspends work at two facilities

By Kim Smiley

Research has been suspended at two National Institutes of Health (NIH) facilities – a National Cancer Institute laboratory working on cell therapy production and a National Institute of Mental Health facility that makes positron emission tomography materials – over concerns about patient safety. A panel of experts determined that these facilities were not in compliance with quality and safety standards and they are shut down pending a review and any necessary upgrades.

A Cause Map, a visual format for root cause analysis, can be built to help understand this issue.  The first step in the Cause Mapping process is to fill in an Outline with the basic background information for an issue, along with how the issues impacts the overall goals. Thankfully, no patient harm has been identified as a result of issues at the facilities, but the potential for patient harm existed and potential impacts should be included on the Outline. No new patients will be enrolled in the affected trials until the issues are resolved and this is an impact to the schedule/operations goal. Once the Outline is complete, the Cause Map is then built by asking “why” questions and the answers are laid out to visually show the cause-and-effect relationships. (Click on “Download PDF” to see a completed Outline and high level Cause Map of this issue.)

So why was work at two NIH facilities shut down? A little background is needed to understand this issue. In April 2015, fungal contamination was found in products that were supposed to be sterile that were prepared at a different NIH facility, the Clinical Center’s Pharmaceutical Development Service. The investigation into the contaminated product found multiple deficiencies, both in the facility itself and in work practices. The deficiencies included a filter missing in an air handling system and insects found in two light bays in clean rooms. (Read our previous blog to learn more.) Following this issue, the director of NIH appointed a panel of experts to review safety compliance at all other NIH facilities that produce sterile or infused products for administration to research participants.

The panel’s evaluation is still underway, but preliminary findings determined that the two facilities in question are not in compliance with quality and safety standards and production has been suspended as a result.  The panel found that NIH has many outdated or inadequate facilities and that personnel lack expertise on applicable regulations, but no specific details about the deficiencies found have been released. NIH plans to do a rigorous review to identify and correct issues found before these facilities resume manufacturing sterile products. No timeline has been given at this point.

The final step in the Cause Mapping process is to identify and implement solutions to reduce the risk of similar errors reoccurring in the future. In addition to correcting the deficiencies found at these facilities, NIH is working on creating more oversight to help ensure manufacturing facilities are in compliance with safety regulations. The panel recommended the creation of both an outside hospital board to oversee the clinical center and a new central office to coordinate research quality and safety oversight.

Only time will tell how effective these solutions prove to be, but I find it promising that NIH proactively reviewed all of the facilities that produce sterile or infused products for administration to research participants following the fungal contamination issues last year.  It may be painful and embarrassing to suspend work at facilities, but the process is at least moving in the right direction if problems can be corrected before patients are harmed.

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

The water crisis in Flint, Michigan

By Kim Smiley

The quality of tap water, or rather lack thereof, in Flint, Michigan has been all over headlines in recent weeks. But prior to a state of emergency being declared and the National Guard being called up, residents of the town reported strangely colored and foul tasting water for months and were largely ignored. In fact, they were repeatedly assured that their water was safe.

Researchers have determined that lead levels in the tap water in Flint, Michigan are 10 times higher than previously measured. Forty-three people have been found to have elevated lead levels in their blood and there are suspected to be more cases that have not been identified. Even at low levels, lead can be extremely damaging, especially to young children under 6. Lead exposure can cause neurological damage, decreased IQ, learning disabilities and behavior problems. The effects of lead exposure are irreversible.

The water woes in Flint, Michigan began when the city switched their water supply to the Flint river in April 2014. Previously, the city’s water came from Lake Huron (through the city of Detroit water system). The driving force behind the change was economics. Using water from the Flint river was cheaper and the struggling city needed to cut costs. Supplying water from the Flint River was meant to be a temporary move to hold the city over while a new connection to the Great Lakes was built within a few years.

The heart of the problem is that the water from the Flint river is more corrosive than the water previously used. The older piping infrastructure in the area used lead pipes in some locations as well as lead solder in some joints. As the more corrosive water flowed through the piping, the lead leached into the water.

A Cause Map, a visual root cause analysis, can be built to document what is known about this issue. A Cause Map intuitively lays out the cause-and-effect relationships that contributed to an issue. Understanding the many causes that contribute to an issue leads to better, more detailed solutions to address the problem and prevent it from reoccurring. The Flint water crisis Cause Map was built using publicly available information and is meant to provide an overview of the issue. At this point, most of the ‘whats’ are known, but some of the ‘whys’ haven’t been answered. It isn’t clear why the Flint river water wasn’t treated to make it less corrosive or why it took so long for officials to do something about the unsafe water. Open questions are noted on the Cause Map by including a box with a question mark in it.

This issue is now getting heavy media coverage and officials are working on implementing short-term solutions to ensure safety of the residents. The National Guard and other authorities are going door-to-door and handing out bottled water, water filters, and testing kits. Michigan Governor Richard Snyder declared a state of emergency in Flint on January 5, 2016 which allows more resources to be used to solve the issue. However, long-term solutions are going to be expensive and difficult.

The city’s water supply was switched back to Lake Huron in October 2015, but it will take more than that to “fix” the problem because there is still a concern about lead leaching from corroded piping. Significant damage to the piping infrastructure was done and the tap water in at least some Flint homes is still not safe. It is estimated that fixing the piping infrastructure could cost up to $1.5 billion. A significant amount of resources will be needed to undo the damage that has been done to the infrastructure of the city, and there is no way to undo the damage lead poisoning has already done to the area’s residents, especially the children.

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

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

Lead Poisoning Still An Issue for US Children

by Kim Smiley

Lead poisoning has once again hit the news with scary headlines such as “Blood Lead Levels High In 535,000 Kids In The USA” and “Despite Big Progress, Many Kids Have High Lead Levels in Blood“.   But what do these articles actually mean in context?  What does “many kids” refer to and how alarmed should we be?

A tool like a Cause Map, a visual method for performing a root cause analysis, can be useful to analyze issues like this one.   The first step in the Cause Mapping process is to define the problem and that alone can help clarify an issue.   Part of defining the problem is to determine which overall organizational goals are being impacted by the problem.   In this example, it becomes clear that there are really two different, but related goals that need to be considered.  The most basic goal is the safety goal.  The safety goal is being impacted because children are still being negatively impacted by exposure to lead in the United States, despite decades of work to dramatically reduce lead in the environment.  The second issue is that 2.6% of children in the US have blood lead levels (BLLs)  higher than the levels set by the Center for Disease and Control (CDC), an impact to the regulatory goal.

It’s clear why exposure to lead remains a concern. Ingestion of lead is dangerous, especially to small children. High levels of lead in the body can have severe and immediate consequences such as coma, convulsions and even death.  Lower levels of lead have been shown to cause lower IQs, behavior issues, hearing problems and a number of problems in organs in the body.  Problems with lead exposure are well known and the use of lead has been dramatically reduced.  Use of lead in household paints, one of the most common sources of ingested lead, was banned in 1978.  However, paint is still one of the primary sources of lead contamination because many children live in houses built before 1978.  Paint chips containing lead can still be an issue, especially if an older house has loose paint or is undergoing a renovation.  Use of lead in gasoline, a common source of soil contamination, was phased out by the end of the 1980s.

The second issue of concern is that 2.6% of children have blood lead levels above the limit set by the CDC.  What does this mean?  If this problem is hitting headlines, are things getting worse?  One important piece of data is that the CDC lowered the limit for young children in 2012 to 5 µg/dL from 10 µg/dL.  Why was the limit lowered?  The limit was lowered because no amount of lead has been determined to be safe for young children and less lead is always better.  The new limit of 5 µg/dL was based on lead levels in the 2.5% of children with the highest levels.  It was a way to target the children most at risk and it marked a shift towards a more prevention-based approach.

Is it okay that 2.6% of children still have blood lead levels above the target?  Of course not.  Is there still work to do in preventing lead exposure?  Many people believe there is.  But the alarming headlines may not tell the whole story.  Here are some other facts that help put the issue of lead exposure in historical context: an estimated 88% of children aged 1 to 5 had blood lead levels at or above 10 mcg/dL from 1976 to 1980; from 1991-1994 it was 4.4% , from 1999-2002 it was 1.6% and it dropped to 0.8% in 2007-2010.    Lead exposure is a still an issue, but it’s an issue that has been drastically improved.

To view a Cause Map of this issue, click on “Download PDF” above.  For more information, click here to visit the CDC’s information page about lead.

 

Root Cause Analysis

Potential Dangers of Unpasteurized Dairy Products

By Kim Smiley

A new study by the Centers for Disease Control and Prevention (CDC) found that unpasteurized milk is 150 times more likely to cause food-borne illness outbreaks than pasteurized dairy.  The CDC found that there were 73 disease outbreaks, two deaths and many permanent disabilities caused by the consumption of unpasteurized dairy products from 1993 to 2006.  Pasteurized dairy products aren’t perfect either.  According to the same report there were 48 disease outbreaks from contaminated pasteurized milk and cheese resulting in thousands of illnesses and one death during the same time period.  But the CDC determined that unpasteurized milk is a far greater risk since more illnesses were caused by it and it is estimated that only about one percent of the population consumed unpasteurized dairy products.

This issue can be analyzed by building a Cause Map, an intuitive, visual format for performing a root cause analysis.  In this example, the safety goal was obviously impacted since hundreds got sick from consuming unpasteurized milk.  The Cause Map is built by asking “why” questions and adding the information onto the Cause Map in order to show the cause and effect relationships between all the factors that contributed to the issue.  In this example, people got sick because they were exposed to harmful microorganisms.  This occurred because unpasteurized milk is more likely to be contaminated with harmful microorganisms and consumers drank unpasteurized milk.

Unpasteurized milk is more likely to be contaminated because by definition it isn’t heated to kill microorganisms.  During the pasteurization process, milk is heated to 161 degrees and held there for about 20 seconds to kill anything harmful that might be in the milk.  There is the potential for all milk to get contaminated because cow manure is a potential source of contamination and it’s a constant in the environment where milk is produced.

People drink unpasteurized milk because they prefer it and it’s legal to buy in many states.  Some consumers prefer unpasteurized milk for a number of reasons.  Unpasteurized milk has a distinct taste some people like.  There is also a general trend of people moving towards less processed foods.  The pasteurization processes decreases the amount of a few nutrients in milk so some people think that unpasteurized milk is healthier for them.  There are also a number of people who believe that unpasteurized milk has healing properties.  There are testimonies that unpasteurized dairy products have reversed a number of health issues, including allergies, asthma, digestive disorders, arthritis and behavior problems in children.

There are some who believe the sale of all unpasteurized diary should be banned because of the risk of contamination and the resulting illnesses, but unpasteurized dairy has very active, vocal advocates that believe strongly that its sale and consumption should be legal.  Both the CDC and the Food and Drug Administration urge consumers to avoid unpasteurized dairy products because of the potential health risks.