Monthly Archives: September 2015

Root Cause Analysis

Smoke from wildfires in West may impact public health across the US

By ThinkReliability Staff

A significant portion of the United States is currently being affected by wildfires. The Valley and Butte fires in California, two of the worst in that state’s history, have killed five (all civilians found dead in their homes). The Tassajara Fire has resulted in another civilian fatality. The Rough Fire (also in California) has burned more than 141,000 acres. The US Wildfire Activity Public Information Map and National Wildlife Coordinating Group Incident Information System shows dozens more fires across the Western United States.

The wildfires are also impacting the population in areas not directly impacted by the fires. Public safety has been impacted by the deaths and risk for injury. Worker safety has been impacted as well; four firefighters were burned in the Valley fire. Even animal safety has been impacted; animals were left to fend for themselves in many areas that were evacuated rapidly due to changing conditions, leading to risk of injury or death. Tens of thousands of people have been evacuated. Hundreds of thousands of acres have been burned and thousands of buildings destroyed, causing a potential long-term impact on area businesses. More than 15,000 workers have been deployed to assist in fighting the fires.

The wildfires are also affecting air quality in areas not directly impacted by the fires. The smoke from these wildfires is causing environmental and health issues including asthma, chronic lung disease and even heart attacks. Janice Nolan, the assistant vice president for national policy at the American Lung Association says of recent air quality, “It’s really bad. I hadn’t seen ‘code maroon’ days, which is the most hazardous air quality, in years.” (The Air Quality Index reports the quality of outdoor air in color categories. Maroon, or “hazardous” represents a level of air pollution that means the entire population is likely to experience serious health effects. Lower categories indicate when members of more sensitive groups may experience health concerns.)

Health issues can occur when smoke is breathed in and enters the respiratory system. The organic particles that make up smoke can be so small they can bypass the body’s natural defenses (such as mucus and hair in the nose). The particles can even enter the bloodstream. This occurs any time a person is exposed to smoke. Says Sylvia Vanderspek, the chief air quality planner for the California Air Resources Board, “If you can smell smoke, then basically you’re breathing it.”

An average person can breathe in about 35 micrograms of particulate matter for only 24 hours before experiencing health problems. Unfortunately, the California air quality board has measured levels of particulate matter up to 34 micrograms in a day . . . and the fires have been burning for weeks and may continue for weeks more. Weather conditions impact not only the wildfires themselves but also where the smoke from those fires goes. Weather conditions this summer have meant that smoke issues have been seen into the Midwest.

The only really effective protection against health impacts from smoke is to stay inside with air conditioning on recirculate if in an affected area (based on the local air quality index). This has meant schools are holding indoor recess and sports practices and outdoor festivals have had to cancel performances. Idaho is considering establishing clean air shelters so the population can avoid breathing in smoke. Regrettably, most air masks won’t help, as they don’t protect against the tiny particles of concern. Instead, health officials reiterate that if the air quality in your area is poor, stay indoors to protect your health.

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

Filter to protect against blood clots implicated in deaths

By ThinkReliability Staff

An NBC investigation released September 3, 2015 raised concerns about the use of a specific retrievable inferior vena cava (IVC) filter, known as the Recovery. The issues behind the concerns are complex and some appear to impact more than one type of filter. A visual root cause analysis, known as a Cause Map, can clearly lay out all the causes associated with an issue, ensuring that all potential solutions can be considered.

The first step in a problem-solving process is to define the problem. Here the specific issue being investigated is the deaths and serious injuries associated with the failure of the Recovery filter. The Recovery was introduced in 2003 and was first implicated in a death in 2004. The Recovery aims to prevent blood clots from reaching the heart or lungs in patients who are unable to tolerate blood thinners and have been placed in a variety of healthcare facilities. An important difference between the expected and actual use of these filters is that studies have found that most are not removed in a timely manner.

The use of Recover filters has impacted the patient safety goal because at least 27 deaths have been related to its use. There are at least 117 lawsuits associated with these problems, impacting the compliance goal. Hundreds of additional non-fatal problems have also been reported, impacting the patient services goal. The operations goal is impacted by the filters not being removed. Lastly, the inadequate holding power of the arms of the filter (meant to hold it in place) can be considered an impact to the property goal.

The analysis begins with one of the impacted goals. Here, the primary concern is the impact to patient safety. The patient deaths result from the filter being pushed into a patient’s heart or lungs. This results from filter migration. In order for the filter to migrate, the force on the filter exceeds the holding power of the arms of the filter. Holding power can be reduced due to improper placement, filter fracture/ failure due to fatigue (a National Institutes of Health, or NIH, study found that 40% of filters fracture within 5.5 years) or design issues. Although these issues can impact any type of blood filter, the Recovery was found to have the lowest resistance to migration of filters examined. Force on the filter can be increased due to exertions, such as bowel movements or respiration, and/or large blood clots. Because these patients are known to have risk factors for blood clotting, this is a particular concern.

The time a filter is in place increases the risk of filter migration. The longer a filter is in place, the more likely it is to be impacted by the concerns discussed above. The use of these filters has been increasing. According to the US Food and Drug Administration (FDA), only 2,000 of these type of filters were installed in 1979; now about 250,000 are installed every year in the US. The devices used are approved by the FDA, though in the case of the Recovery, there are questions about the legitimacy of the review process; a “signer” on the application says her signature was forged. However, studies have found that evidence-based guidelines for implantation of these filters is not being followed, potentially leading to inappropriate use.
These filters (though designed to be temporary) are not being removed. A retrospective review of filter implantations published in the American College of Surgeons Surgery News found that only 1.6% of retrievable filters were removed during the 3-year study period. In 4.2% of cases each, filters were unable to be removed due to technical difficulties or thrombus within the filter. In most cases, though, it appears there was no attempt to remove the filter, believed to be due to a lack of physician oversight.

According to a FDA safety communication, physicians that implant a retrievable filter must remove it as soon as “feasible and clinically indicated”. This is true for all retrievable IVC filters, not just the Recovery. However, implanted Recovery filters are a particular concern – they are more prone to problems and haven’t been sold since 2005. If you believe you have an implanted filter, talk to your doctor about next steps.

To view a downloadable PDF with the causes of the filter issues, click on “Download PDF above. To learn more:

NBC Investigation

NIH Study

ACS Surgery Study

FDA Safety Communication

Root Cause Analysis

Saving lives by helping parents remember

By ThinkReliability Staff

Vaccination programs that increased the worldwide availability of vaccines have resulted in an estimated 7 million children surviving who would otherwise have died of preventable disease since the year 2000. Preventable diseases are those that can be prevented with a proper vaccination schedule.

However, about 1 in 5 children miss recommended vaccinations, leading to an estimated 1.5 million deaths that still happen every year from preventable diseases. Although the vaccines are getting to medical facilities across the world, children still need to be brought to the vaccines.   Parents may choose not to have their children vaccinated, typically due to a concern about the side effects (as occurred in the Disneyland measles outbreak, the subject of a previous blog.)   In some cases, parents just forget about the increasingly complex vaccination schedule.

People forget things; it’s a fact of life. But when parents forget about recommended vaccines, preventable disease and potentially death can be the result. Various solutions have been implemented across the world to make sure that all children receive all recommended vaccines. Potential solutions are evaluated on how easy they are to implement and how effective their planned result. Ideal solutions (“low-hanging fruit” or “slam dunks”) are solutions that are very effective and simple to implement.

The effectiveness and ease of implementation of solutions is dependent upon the circumstances. For example, calling parents to remind them of their child’s vaccine schedule is pretty effective – but it’s far easier to implement in a developed country than in a developing country. Thus the same solution – a phone call – appears in the “low hanging fruit” quadrant in developed countries, and in the “capital project” for developing countries. Click on “Download PDF” above to see how a solutions matrix may look for this issue.

Other solutions that have been implemented across the globe to help ensure children get all their recommended vaccines include:

– An anklet that fits around a newborn’s ankle with a punch-out reminder for each vaccine that costs only 10 cents each and has been tested in Peru & Ecuador (91% of 150 mothers surveyed said the bracelets helped them remember)

– Town criers in the villages of Burkina Faso made announcements about meningitis vaccines and community health workers went door-to-door answering questions about the vaccine (11 million people aged 1 to 29 were vaccinated within 10 days)

– PATH, a nonprofit that works on vaccines, provides poster templates advertising the importance of vaccines

– Rotary International had vaccine announcements added to the skirts of women in Kenya

– In India, an extensive polio vaccination program including transit and follow-up teams which led to the country being removed from the endemic polio list (see our previous blog)

All of these solutions have the potential to reduce deaths from preventable disease by increasing vaccination rates. In this case, as in many others, the most effective solutions need to be selected carefully. “Cultures, leaders and messaging are different in each country. So you have to study and use what’s most likely to work in order to build trust that the vaccine will be helpful,” says Amrita Gill-Bailey a team leader at Johns Hopkins Center for Communication Programs.