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.

Root Cause

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.

Root Cause

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.”

Root Cause

Analysis of Causes of Patient Data Breaches

By ThinkReliability Staff

When dealing with a seemingly overwhelming problem, care should be taken to ensure that resources are used most effectively by addressing the causes that have the biggest impact on the issue.  Take the case of HIPAA breaches of medical records.  Since February of 2010, 26.8 million individuals in the United States have been impacted by a data breach.  There are multiple potential causes that could result in these data breaches. So, where should efforts be directed to be most effective?

Looking at actual events and determining the probability of different types of failure can better direct your solutions, even if your organization hasn’t personally experienced a data breach.  We do this in a proactive Cause Map, which looks at potential causes and – when data is available – determines the relative probability of each contributing cause.  Luckily for us, this analysis has already been performed for data breaches reported to the HHS since February 2010.  We will use here breach analysis and graphs created by medical software research resource Software Advice in a recent report on the subject.

The biggest cause of patient data record breaches is theft.  Theft accounts for at least 48% of breaches.  (There were also incidents described as combination, other or unknown, which may also involve theft.)   As an example, a health insurance provider lost nine server drives that included information for 1.9 million people, two years after a portable disk drive was stolen that included personal data for 1.5 million members.  (View our analysis of patient data breaches caused by theft in our previous blog.)

The next largest cause of patient data breaches is unauthorized access.  Unauthorized access is the cause of 18% of data breaches.  These types of breaches have the potential to result in employee action in addition to the other goals that are impacted.  These events may involve outside contractors, or “Business Associates” (BAs).  BAs are involved in 22% of incidents, but account for 48% of impacted individuals due to data loss.  An example of a patient data breach caused by an outside contractor is the case involving records of 20,000 patients, which were posted online by a contractor.  (View our analysis of this data breach in our previous blog.)

Loss accounts for 11% of patient data breaches.  This includes the largest patient data breach from the time period covered, when a TRICARE BA (contractor) lost backup tapes, impacting the records of nearly 5 million patients.   Improper disposal, such as when a shredding company abandoned the records of 277,000 patients in a public park, accounts for 5%.  Hacking also occurred in 6% of breaches, such as when the servers at the Utah Department of Health were broke into and records for almost 800,000 people were stolen. (Remaining events are classified as a combination of the above, other, or unknown.)

The HIPAA Omnibus Rule clarified liability for Business Associates and subcontractors, which should serve to reduce their involvement in data breaches.  But for the events that don’t involve outside parties, how can these events be reduced?

Focusing on two of the most likely causes of breach – theft and loss – encryption can reduce the risk that data can be accessed if physical devices are stolen.  Laptops account for 22% of breaches, and other portable devices account for 12%.  However, encryption won’t help with paper records, which account for 23% of data breaches.  In these cases, limit to access of records and prevention by removing records from the storage site can help, as can moving from paper records to electronic health records, which accounted for only 2% of  data breaches.  However, the storage devices used for electronic health records, including laptops, as discussed above, network servers (10%), computer (13%) are more likely to be involved. Because physical storage devices account for so many data breaches, whether or not electronic records are being used, cloud storage is worth consideration.  Although hacking is still a concern, remember that it accounts for just 6% of breaches – as opposed to theft and loss, which make up nearly 60% of breaches.

To view the proactive analysis/ Cause Map of these data breaches, please click “Download PDF” above.  Or click here to read more.

Root Cause

Glitches with Federal Health Care Exchange Website Cause Concern

By ThinkReliability Staff

The website to allow individuals to sign up for the federal Health Care Exchange created as part of the Affordable Care Act opened at midnight on October 1, 2013.  Delays and glitches with the site itself caused difficulties for many trying to enroll.  Three million visitors are said to have visited the site between midnight and 4 p.m. on opening day, though the numbers of how many were actually able to enroll will not be released until November.

This creates a problem not only from a customer service perspective (though that is certainly an important impact to the federal government’s goals of trying to create a consumer-friendly website), but also with regard to the mission of providing affordable healthcare to the population and the labor and time required by federal workers for its success.  Because the cost for healthcare is more for older, sicker parts of the population, more younger, healthier people will need to sign up for the exchanges to keep the insurance affordable.  Some people who go to the website are now being directed to apply by phone, or mail, but because the site incorporates automatic verification of personal information, that will need to be done manually by employees when people apply in other ways, this increases the cost of the program.

Though specific details on some of the issues facing the exchange have not yet been released, there are some known issues that have been discussed in the media.  One of these is the available capacity for the site.  The site was planned for a maximum of 50,000 simultaneous users.  During the first day of the exchange, the site saw up to five times that many simultaneous users.  The numbers are presented as being based off the 30,000-maximum simultaneous users to the Medicaid site, but how the actual number was determined is unknown.  An increased burden on the site due to the 36 states that decided not to create their own state-run exchange contributed to the high number of users.  It was thought that the promise of federal money to support the state-run exchanges would encourage more states to participate.

The requirements for the website have been described as “unprecedented” – not only was the website designed to handle a high number of simultaneous users, it also has to share information from multiple data sources, including the Internal Revenue Service, Social Security Administration, and Homeland Security to verify information and determine access to plans and tax credits.  Based on the number of glitches and delays seen in the first weeks of the exchange website, the testing of the launch appears to have been inadequate.  Factors that may have played a part are lack of funding due to lack of support for the Affordable Care Act by Congress, and a delay in creating the infrastructure of the system over a concern that the Act would be overruled by the Supreme Court or Congress.

Information technology experts say that lessons learned from other sites – such as state-run exchanges that have already been successfully operated, or even the Medicaid site – were not applied effectively to the exchange.  The organization tasked with oversight of the exchange – Centers for Medicare and Medicaid Services (CMS) – has little experience with managing a website of this magnitude.  It has also been suggested that the contractors hired to support the site may be less able to react because government contracting can be preferential towards older, more entrenched companies.

As more information is released, the analysis of an issue becomes more detailed and allows for more effective, deliberate solutions.  The information that is currently publicly available was used to create an initial, high level Outline and Cause Map.   (To view the Outline and Cause Map, please click “Download PDF” above. )

As an immediate, but temporary solution, an online waiting room was created in hopes that it would allow an increased number of users to be on the site at the same time.  Additionally, the ability to browse anonymously – without creating a profile – was incorporated, in hopes that this would decrease traffic to parts of the site that require personal information verification for those who are just looking at the site.

A team of experts has been tapped to fix the glitches with the site.  It’s not clear who will ultimately be responsible for the fixes, though many have recommended the creation of a new position to oversee the entire exchange.  If issues with the site continue to cause delays, the sign-up period may be extended as a back-up solution.  The administration will be watching the fixes to the site carefully and determining what more is needed.  However, they’ve got to hurry – the enrollment period ends December 15 for coverage by January 1, 2014.

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

Root Cause

United Nations Sued for Role In Haitian Cholera Epidemic

By Kim Smiley

A class action law suit has been filed against the United Nations (U.N.) on behalf of Haitian families afflicted by the cholera epidemic that has been raging since 2010.  Many believe that cholera was inadvertently brought to Haiti by U.N. peacekeeping forces.

Some of the basic facts are still debated, but one that is known is that Haiti is experiencing the worst cholera epidemic in modern history with thousands of new cases each month. Nearly 7 percent of the Haitian population has had cholera since 2010.  It’s estimated that around 8,400 people have died of cholera and more than 685,000 have been sickened by the disease.

So why is the U.N. being blamed for this epidemic? A Cause Map, or visual root cause analysis, can be used to explain what many believe occurred.  All causes that contributed to an issue are captured on the Cause Map, which illustrates the cause-and-effect relationships between them.  In this case, people became infected with cholera after drinking contaminated river water.  Many believe that the river was contaminated when sewage leaked from a U.N. camp near the river with inadequate sanitation facilities.  U.N. peacekeepers from Nepal were stationed at the camp and cholera, specifically a nearly identical strain of cholera, was present in Nepal at the time.  It’s assumed that at least one person in the camp had cholera and dangerous wastes managed to contaminate the river. The cholera epidemic seems to be a deadly case of unintended consequences that occurred when the U.N. attempted to aid Haiti following a devastating earthquake.

Once cholera got a foothold in Haiti, the epidemic exploded.  The population had little immunity to the disease because a case hadn’t been seen in Haiti in over a century prior to 2010.  Haiti lacked the sanitation and medical facilities to quickly contain a cholera epidemic.  People continued to drink water from the river because there weren’t many other options. The country had also suffered major damage from the 7.0 magnitude earthquake that hit on January 12, 2010.  Medical facilities, transport facilities, communication systems and all the things a country needs to battle an epidemic had been significantly impacted by the earthquake.  Basically, it was a perfect recipe for a disaster.   A sick U.N. soldier may have brought cholera to Haiti, but the conditions in the country amplified the situation.

The world is still struggling to understand the cholera epidemic and determine what lessons learned should be applied going forward.  Clearly there is something to learn about the need for sufficient sanitation so that illness doesn’t spread unnecessarily.  The U.N. may potentially want to screen troops more closely before stationing them on foreign soil or implement other changes to help prevent anything like this from occurring in the future.  It’s also a powerful reminder to be aware and on the lookout for unintended consequences whenever a solution is implemented.  For example, the U.N has always had legal immunity, but some believe that may change as a result of the cholera lawsuit.   It’s impossible to predict if a verdict against the U.N. would impact future U.N. aid efforts, but it’s easy to imagine that it could have damping effect on their efforts, causing a whole other wave of unintended consequences to occur.

To view a high level Cause Map of the cholera epidemic in Haiti, click on “Download PDF” above.

Root Cause

National Effort Improves Cardiac Arrest Survival Rates

By ThinkReliability Staff

October is Sudden Cardiac Arrest (SCA) Awareness Month.  In Northern America, more than 300,000 people are affected every year by out-of-hospital SCA, which occurs when the heart no longer beats properly.  According to the American Heart Association, about 92% of SCA victims die before reaching the hospital.

Survivability of SCA is dependent on the length of time between SCA and chest compressions that allow blood flow to the heart and brain.  This can be accomplished by non-medical personnel using Cardiopulmonary Resuscitation (CPR), known as “bystander CPR”, which can provide lifesaving treatment for a victim of SCA until medical personnel arrive.

In Denmark, the rate of patients who received bystander CPR in 2001 was 21.1%.  The country embarked on a national initiative to improve SCA survivability.  This initiative included increased training of residents as early as elementary school.  Instructional kits were provided, and learning CPR was required in order to receive a driver’s license.  The percent of patients who received bystander CPR increased from 2001 to 2010 to 44.9%.

In addition to the increased education of the general population about CPR, changes were made to improve care provided after SCA by hospitals and emergency medical services.  According to a study in the Journal of the American Medical Association, these changes together have improved the survivability of all stages after SCA.  From 2001 to 2010 in Denmark, cardiac arrest patients arriving at a hospital alive increased from 7.9% to 21.8%.  In addition, 30-day and 1-year survival also increased, from 3.5% to 10.8% and 2.9% to 10.2%, respectively.

Denmark’s initiative hopes to lessen the reluctance bystanders may have to perform CPR due to lack of training.  In addition, the American Heart Association recommended in 2008 that laypersons perform compression-only CPR (no breaths) if they are unable or unwilling to provide rescue breaths.  This may have also decreased the reluctance of bystanders to perform CPR due to concerns about spread of disease, or feeling uncomfortable giving rescue breaths.

Providing additional training to emergency medicine providers can also improve survivability.  Another recent study by the University of Arizona has found that improving the quality and effectiveness of CPR performed by emergency medicine providers improved survival rates.  In the study, rescuers were provided real-time feedback as to the quality of the CPR being provided, as well as training that emphasized a team approach.  Before these interventions, 26% of SCA victims survived to hospital discharge.  After the interventions, 56% of victims survived to discharge.

Although CPR dates back to 1740, improvements in availability and quality are still being found that can increase survivability of SCA victims.  Because of the importance in quick and effective action, the importance of action by non-medically-trained bystanders to the survival rate after SCA provides strong support for layperson CPR training.

To view the Outline and Cause Map including the cause-and-effect of the improvements to survival rate in Denmark as a result of interventions and improvements, please click “Download PDF” above.

Root Cause

New Prostate Cancer Tests Look Promising

By Kim Smiley

One in six American men will be affected by prostate cancer during their life making prostate cancer the most common non-skin cancer.  Despite the number of people impacted by this disease, screening and treating prostate cancer remains problematic and even controversial at times.

This issue can be analyzed by building a Cause Map, an intuitive format for performing a root cause analysis.  The first step in the Cause Mapping process is to fill in an Outline with the basic background information.  How the issue impacts the overall goals is also documented in the Outline.  In this example, there are several significant impacts that need to be considered.  The first is that it’s estimated that about 30,000 men will die from prostate cancer in the US in 2013.  The second major issue is that many men are treated unnecessarily for prostate cancer.  Unnecessary treatments are a waste of resources and the side effects cause significant suffering.  The next step of the Cause Mapping process is to build the actual Cause Map by asking “why” questions and laying out the causes visually to show the cause-and-effect relationships.  (To see a high level Cause Map for this issue, click on “Download PDF” above.)

One of the factors that leads to so many deaths from prostate cancer is that it is generally found at later stages.  Most patients have few symptoms with early stage prostate cancer and current screening methods for prostate cancer are far from perfect.  Conditions other than prostate cancer, such as enlarged prostates, can result in positives during blood tests for prostate cancer.   The positive indications of cancer then trigger needle biopsies in areas of the body no one wants biopsied.  Less than half of these follow up biopsies find cancer cells. Physical exams for prostate cancer are uncomfortable and usually only find larger cancers.  Additionally, many prostate cancers grow so slowly that they will not impact a patient’s life span and do not require treatment, but there is currently no test that can accurately determine whether a prostate cancer is dangerous.

This inability to distinguish between types of prostate cancer is what leads to so many being treated unnecessarily for prostate cancer.  Many patients opt for treatment once prostate cancer is found because they have no way of really knowing whether it’s safe to leave the cancer untreated.   But treatment is not without significant costs, both financially and in suffering.  Many of the prostate cancer treatments, such as radiation or surgery, can cause major side effects such as  incontinence or sexual dysfunction.  Most patients will willingly undergo treatment for life threatening cancers, but it’s terrible that some patients endure cancer treatments without need.

The final step in the Cause Mapping process is to find solutions.  In this example, the good news is that many researchers are working to develop better prostate cancer tests, which would rapidly lead to better patient care.   Better tests could save lives by finding prostate cancers earlier and could help reduce unnecessary treatment by identifying the more dangerous cancers.  A urine test for prostate cancer is now available that has been found to be more accurate than current screening methods.  Other research groups are working to develop other urine prostate tests with a focus on developing accurate, low cost tests that can be performed at home.  None of these tests are perfect yet, but they are a significant step in the right direction.

 

Root Cause

How Best to Prevent Patient Falls?

By ThinkReliability Staff

Though there is consensus that improvement must be made in the area of injury due to patient falls, how to reduce patient injury due to falls has raised questions about effective solutions to this problem.

According to the Agency for Healthcare Research and Quality, accidental falls contribute to patient complications in 2% of hospital stays.  Specifically in the state of Washington, where potential legislation aims to reduce the risk of patient falls, falls are found to kill or injure a few dozen patients per year.  The American Nurses Association said in a statement: “Falls are a leading driver of healthcare costs, especially for the elderly.  What’s more, Medicare and Medicaid do not reimburse hospitals for costs associated with injuries from inpatient falls, essentially increasing unreimbursed hospital healthcare costs.”  Obviously, patient falls cause an impact to both patient safety and quality of care, and may affect hospital reimbursement.

A recent fall case in Washington raised some of the concerns at the forefront of the falls prevention debate.  A patient was badly injured after he fell while being medicated with a sleeping pill (zolpidem).  A study has found that hospital patients taking zolpidem are four times more likely to fall. Some hospitals have begun phasing out zolpidem as a sleeping pill because it makes patients more likely to fall.

Most hospitals rely on a fall risk assessment for their patients to determine the level of fall prevention care required.  However, changes in patient status – such as the use of medication that increases fatigue or confusion – must cause a re-evaluation of a patient’s risk.  For hospitals that continue to offer zolpidem, its use may lead to a patient that was previously classified as a low fall risk becoming a high fall risk, leading to additional protocols or care depending on the hospital’s fall prevention plan.

Studies show that more nurses result in fewer patients falling.  Nurses in Washington have supported legislation requiring higher staffing levels.  But hospital management is concerned about the cost of this requirement, although the hospital did add 29 more nurses at the hospital where this fall occurred.   Additionally, that hospital’s Chief Nursing Officer says “What we have found is it has much less to do with staffing ratios than with having good solid reliable processes in place and following those every single time.”

Many of these processes involve bed alarms – which some studies have shown to be ineffective at preventing falls.  Additionally, as a nurse states, “You still need a person to be close enough nearby to be able to respond to the alarm.”

When looking at the causes that result in an issue impacting the organization’s goals, the analysis step may seem like the most difficult part to get through.  However, in many cases, especially where patient safety, staffing, funding and reimbursement come into play, it can be even more difficult to determine which solutions should be implemented to reduce the risk of the issue recurring, especially when studies may offer conflicting or confusing evidence about the effectiveness of various interventions.  In this case, it is particularly important that organizations determine the required reduction in risk (in this case, most hospitals are attempting to end patient injury due to falls) and the solutions (interventions) that will result in that reduction based on the needs and available resources of the organization.

Most importantly, after a specified time period, the solutions need to be evaluated for effectiveness, based on carefully determined criteria.  In this case, whatever intervention is selected to reduce injury from patient falls should be evaluated against the number of injuries due to falls at that facility.  If the risk has not been reduced as desired, additional interventions are in order.

To view the fall issue discussed here in a Cause Map, with notes about solutions under consideration for reducing fall risk, please click “Download PDF” above.  Or click here to read more.

Root Cause

Increase in Resistant Bacteria and Fungus Threatens Public Health

By ThinkReliability Staff

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

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

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

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

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

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

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

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

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

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