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.

FDA Proposes Restrictions that Would Essentially Ban the Use of Trans Fats

By Kim Smiley

On November 7, 2013, the US Food and Drug Administration (FDA) proposed reclassifying trans fats so that they would no longer be “generally recognized as safe.”  This move would essentially eliminate the use of trans fats because companies would need to prove that they are harmless before adding any to food products.  This hurdle would likely be impossible to jump since current research shows that trans fats are the least healthy fat and contribute significantly to heart disease in the US.  In fact, it’s estimated that the increased restrictions on trans fat proposed by the FDA would prevent 20,000 heart attacks and 7,000 deaths from heart disease each year.

Trans fats are an especially dangerous form of fat because they raise the levels of “bad” cholesterol, while also lowering the “good” cholesterol.  This double whammy significantly increases the likelihood of heart disease. One of the interesting twists in the history of trans fat is that its rise to popularity was partly fueled by a belief that it was a healthy alternative because it was manufactured from plants, unlike traditional saturated animal fat like butter or lard.    Trans fats were also cheaper, increased product shelf life and were kosher.   From the 1950s until recently, trans fats were widely used in a variety of processed foods.

Things began to change in 2003 as more and more research showed that trans fats were less healthy than initially thought and the FDA added a requirement that artificial trans fats be listed separately on food labels.  Manufacturers begin to shift away from the use of trans fats after their visibility was increased and the public became more aware of the dangers of trans fat.  The shift away from the use of Trans fats has already dramatically impacted the American diet.  In 2006, Americans consumed an average of 4.6 grams of trans fats daily which decreased to about 1 gram in 2012.  Food manufacturers are not predicted to fight the new FDA proposal too aggressively since so many have already voluntarily reduced the use of trans fats.  Additionally, no company wants to be associated with the negative publicity surrounding trans fats.

The impacts of trans fats can be analyzed by building a Cause Map, a visual root cause analysis, which intuitively lays out causes that contribute to an issue to visually show the cause-and-effect relationships.  A Cause Map is built by determining how the overall goals are impacted by issues and then asking “why” questions to determine all the causes that contributed to the problem.  Click on “Download PDF” above to view a high level Cause Map of this issue and view a completed Outline.

After Hurricane Sandy, Medical Centers Work to Prevent Future Issues

By ThinkReliability Staff

As a result of both infrastructure damage and power failures due to Hurricane Sandy, five major hospitals in the New York City area had to be evacuated (see our previous blog about one hospital’s evacuation).  Medical centers in the impacted areas are still recovering, while trying to determine what should be done to prevent future risk – and who should be responsible.

Historically, it’s been difficult to tell whether or not a hospital’s emergency plan is adequate until it’s tested.   In May of 2011 (less than 6 months before Sandy hit), the U.S. Department of Health and Human Services announced that a majority (over 76%) of hospitals that were part of the National Hospital Preparedness Program “met 90% or more of all program measures for all-hazards preparedness in 2009”.  Many of the hospitals that were evacuated had earned accreditation by the Joint Commission – which includes criteria for emergency preparedness and backup power capacity.   In fact, according to the Joint Commission, the hospitals that were forced to evacuate would still be accredited based on the existing codes.  Says George Mills, the director of the Joint Commission’s Department of Engineering, “Yes, we would accredit them. We have no standards that say get your generator out of the basement.”

But that is exactly what many hospitals that have been affected by storm surges are doing.   NYU Langone Medical Center has upgraded its infrastructure and purchased flood barriers which can be deployed in the case of flooding. The hospital was reimbursed $150 million for rebuilding costs by the federal government shortly after the storm.  Bellevue Hospital Center, where the basement flooded in 45 minutes and took 5 days to pump out, also installed flood barriers and will be raising its backup generator’s fuel pumps from the basement.  Coney Island Hospital has elevated its outside electrical equipment and installed temporary barriers, but is looking at the elevation of its emergency department, which is on the first floor.  (In addition, the Manhattan Veterans Affairs Medical Center evacuated before the storm and experienced complete flooding of the basement and ground floor, resulting in power failures.  Also evacuated were 200 patients from the Henry I. Carter Specialty Hospital and Nursing Facility.)

The city’s Health and Hospitals Corporation President Alan Aviles says the cost of repairs, response and long-term protection from floods will be more than $800 million.  The projects will not be started until the city ensures that the Federal Emergency Management Agency (FEMA) will cover the costs.

According to Al Berman, the head of disaster recovery organization DRI International, the city won’t know how effective these measures have been unless much more rigorous testing is done . . . or until the next storm hits.  In his words, “A disaster is a terrible time to test your plan.”

The information related to the impacted goals as a result of the evacuations from Hurricane Sandy are captured in an Outline, the causal relationships leading to the evacuations and the proposed solutions are captured in a Cause Map, which can be viewed by clicking “Download PDF” above.  The Cause Map allows us to visually capture the cause-and-effect relationships in a logical, organized manner that clearly demonstrates the impact of various causes and the benefit of proposed solutions.

What about the hospitals that managed to weather the storm?  The Shorefront Center for Rehabilitation and Nursing Care in Brooklyn, just a few yards from the Atlantic Ocean, was praised for its handling of the storm – and assistance it provided to other healthcare facilities.  Says their administrator, Loyola Princivil-Barnett, “Our executive team have been taking, and are taking, emergencies very seriously.  It’s a matter of life and death.”