Tag Archives: solutions

What’s the best way to screen for breast cancer? Opinions differ.

By ThinkReliability Staff

In 2015, there were 40,000 deaths from breast cancer and 232,000 new cases of breast cancer in the United States. It is the second-leading cause of cancer death in women in the United States. The very high level cause-and-effect is that people (primarily women) die from breast cancer due to ineffective treatment. The later the cancer is detected, the later the treatment begins so early detection can help prevent breast cancer deaths. Currently the best solution for detecting breast cancer is a mammogram. But the matter of when mammograms should occur is based on risk-benefit analysis.

There’s no question that mammograms save lives by detecting breast cancer. This is the benefit provided in the analysis. Lesser known are the risks of mammograms. Risks include false negatives, false positives, unnecessary biopsies, and unnecessary treatment. The radiation that may be used in treatment can actually be a cause of future breast (and other types) of cancer.

On January 11, 2016, the United States Preventive Services Task Force (USPSTF) issued an update of their guidelines on mammogram starting and ending age (as well as other related recommendations). To develop these recommendations, the task force attempted to quantify the risks and benefits of receiving mammograms at varying ages.

For women aged 40 to 49, the task force found that “there is at least moderate certainly that the net benefit is small.” The net benefit here reflects the benefits of screening (~.4 cancer deaths prevented for every 1,000 screened and an overall reduction in the risk of dying from breast cancer from ~2.7% to ~1.8%) compared to the risks of screening. Risks of mammograms every other year for women aged 40 to 49 include ~121 false positives, ~200 unnecessary biopsies, ~20 harmless cancers treated, and ~1 false negative for every 1,000 women screened. The task force determined that in this case, the benefits do not significantly outweigh the risks for the average woman. Thus, the recommendation was rated as a C, meaning “The USPSTF recommends selectively offering or providing this service to individual patients based on professional judgment and patient preferences.” (Women who are at high risk or who feel that in their individual case, the benefits outweigh the risk, may still want to get screened before age 50.)

For women aged 50 to 74, the task force found that “there is high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial.” The types of benefits and risks are the same as for screening women ages 40 to 49, but the benefits are greater, and the risks are less. For women aged 50 to 74, there are ~4.2 cancer deaths prevented for every 1,000 screened and an overall reduction in the risk of dying from breast cancer from 2.7% to ~1.8%.   Risks of mammograms every other year for women aged 50 to 74 include ~87 false positives, ~160 unnecessary biopsies, ~18 harmless cancers treated, and ~1.2 false negatives for every 1,000 women screened. The task force determined that for women aged 50 to 74, the benefits of mammograms every other year outweighs the risk. Thus, the recommendation was rated as a B (the USPSTF recommends the service).

The task force determined it did not have enough evidence to provide a recommendation either way for screening women over age 74.

Comparing these risks to benefits is a subjective analysis, and some do not agree with the findings. Says Dr. Clifford A. Hudis, the chief of breast cancer medicine at Memorial Sloan Kettering Cancer Center, “The harm of a missed curable cancer is something profound. The harm of an unnecessary biopsy seems somewhat less to me.” To those that disagree, the task force reiterates that personal preference should determine the age screening begins. However, insurers may choose to base coverage on these recommendations. (Currently, private insurers are required to pay for mammograms for women 40 and over through 2017.)

Determining these recommendations – like performing any risk-benefit analysis – was no easy task and demonstrates the difficulty of evaluating risks vs. benefits. Because these analyses are subjective, results may vary. To view the risk vs. benefit comparison overview by the task force, click on “Download PDF” above.

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.

More than 2,700 babies are born with microcephaly in 2015 in Brazil

By Kim Smiley

In 2014, fewer than 150 babies were born with microcephaly in Brazil, but the number dramatically increased in 2015 with more than 2,700 cases.  Microcephaly is a neurological disorder where the growth of the head is stunted with reduced brain function in 90 percent of cases.  Infants with microcephaly often have reduced life spans and require significant long-term care.  The spike in microcephaly is so alarming that some doctors and health officials are encouraging women in the regions with a high concentration of microcephaly cases to avoid becoming pregnant at this time.

Health officials are still working to understand exactly what caused the increase in microcephalic babies, but many believe Zika virus is contributing to the problem.  Zika virus is a mosquito-borne virus and the symptoms are similar to many other mosquito-borne viruses such as dengue and chikungunya.  Latin America reported their first Zika virus cases in 2014 and the spread of Zika virus matches the timing of the increase in microcephaly cases.  Additionally, many mothers of babies with microcephaly report having symptoms associated with Zika virus early in their pregnancies.

A Cause Map, a visual root cause analysis, can be built to illustrate what is known about this issue as this time.  As more information becomes available the Cause Map can easily be expanded to incorporate new information.  A Cause Map is built by asking “why” questions and laying out all the causes that contribute to an issue to show the cause-and-effect relationships. Understanding all the causes that contribute to an issue can aid in development of effective solutions.

In this example, more evidence is needed to confirm that Zika virus is responsible for the microcephaly increase in babies.  (A box with a question mark on a Cause Map indicates areas where more information is required.) The timing of the increase in microcephaly cases and the spread of Zika virus is certainly suspect, but additional data will be needed to ensure that other factors aren’t involved as well.  An autopsy on a baby born with microcephaly revealed the presence of Zika virus, which is another data point, but again isn’t enough to conclusively prove the connection between Zika virus and microcephaly.

Tracking cases of Zika virus is difficult for several reasons.  Many people infected with Zika virus have no symptoms so it is difficult to determine exactly how many have been infected, including pregnant woman.  Zika is spread by mosquitos so everyone in the region is potentially exposed.  Only a few labs in Brazil have the capability to test for Zika virus which makes researching the virus more difficult.  Scientists are working on solving this mystery as quickly as they can, but reality is it will likely be some time before the connection between Zika virus and microcephaly is definitively proven or disproven.

Health officials are working to reduce the number of mosquitos in Brazil, even going door-to-door to look for potential breeding locations.  Reducing the number of mosquitos should hopefully reduce the number of cases of microcephaly if the suspicion about the involvement of Zika virus is correct.  Additionally, pregnant women are encouraged to stay indoors and wear plenty of insect repellant to prevent mosquito bites.  And of course, woman may want to avoid pregnancy as recommended until the mystery is solved, but this obviously isn’t always possible or practical.

To view an initial Cause Map of this issue, click on “Download PDF” above.

Equipment, procedural failure lead to resident scalding

By ThinkReliability Staff

While equipment and procedures were both in place to prevent resident scalding from too-hot baths, failures of both resulted in a resident receiving serious burns on August 13, 2013. The Health and Safety Executive (HSE) report was recently released on the incident, which resulted in prosecution for the care home and the employee responsible for the bath.

This incident illustrates the limitation in looking for the “one” root cause. There wasn’t just one thing that resulted in this incident; rather multiple failures were required to result in the tragic scalding. We can show these causes by performing a visual root cause analysis, known as a Cause Map. Note that the term “root cause” refers to a system of causes, much like the root of a plant is a system.

We begin the analysis by looking at the impact to the goals. Resident safety was impacted due to the very serious burning of a resident. The burning was so severe it resulted in the amputation of ten toes and the resident will never walk again. In addition, employee safety is impacted because of the emotional impact to the employee (known as the second victim). The employee safety is also impacted due to a risk of burns. The environmental goal is impacted due to the lack of temperature control and the compliance goal is impacted due to the prosecution of both the employee and the care home. Resident services are impacted from a resident being placed in a scalding bath. The failure of a thermostat is an impact to the property goal and the time required for response and investigation is an impact to the labor and time goal.

Beginning with one of the impacted goals (in this case we’ll begin with the resident safety goal) and asking “why” questions develops the cause-and-effect relationships that caused the incident. In this case, the resident’s injuries resulted from being placed in a scalding bath and being unable to exit due to physical and communication limitations. The resident was placed in the too-hot bath because the water in the bath was too hot, and the caregiver placed the resident in the bath. Both of these things (the water temperature being too high, and the caregiver placing the resident in the bath) had to occur in order for the injury to occur.

The water temperature was too high because of the failure of the immersion heater thermostat. The reason for the failure, as well as how long it was not working, is unknown. The caregiver placed the resident in the bath because she did not check the water temperature and failed to realize it was too hot. The caregiver appears to have been unaware of the thermostat failure, or certainly there would have been other safeguards in check. Additionally, there were inadequate thermometers provided to check the water temperature. (A manual check for comfort was still possible, though in this case could have resulted in a burn to the employee.) Although it was “required” to test the water temperature and record that the check had been done, there were no written instructions to that effect.

The care home has purchased portable thermometers for caregivers’ use, but the HSE also recommends the use of a secondary thermostatic cut-out, which would prevent boiling of the water tank even if the thermostat failed. The HSE has also provided a white paper “Managing the risks from hot water and surfaces in health and social care“, that discusses appropriate risk assessments and control measures to prevent burns of vulnerable care home residents.

To view the Cause Map of this incident, click “Download PDF” above.

Or, click here to read the HSE report of the incident.

Price of Daraprim jumped ~5,000%

By Kim Smiley

The cost of prescription drugs have been in the news the last several years as the United States struggles to deal with rising health care costs, but few stories have come close to generating as much outrage as the recent massive price increase of Daraprim.  As new specialty drugs hit the market, they are often expensive as drug companies recoup the costs of development and maximize profits while the drug is covered by patents, which may be frustrating but is understandable.  That is not what happened in the case of Daraprim, a lifesaving drug used as an antimalarial drug and to treat toxoplasmosis.  The medication has been around since the 1950s and isn’t covered by any patents.

So why has the price of Daraprim suddenly increased about 5,000 percent?  A Cause Map, or visual root cause analysis, can be used to intuitively show the causes that contributed to the issue.  (To view an outline and a High Level Cause Map, click on “Download PDF” above.) This is one of those issues where it may be tempting to identify the “root cause” or focus on a single cause that contributed to the issue, but there are many factors that need to be considered.  The piece of the puzzle that is probably the easiest to focus on is the fact that a new company bought the only company with regulatory approval to sell the drug in the United States and significantly raised the price.  Basically, there is demand for the drug and the company which has a monopoly on the supply in the US took advantage of it by increasing the price per pill from $13.50 to about $750.

The CEO of the company has been widely villainized for what many consider a predatory price increase, but it is important to remember that the Daraprim price increase was legal.  Many find the price increase distasteful, but there are currently no laws or regulations that prevent huge medication price increases, which is another cause that contributed to the issue.

While a generic version of the drug is available in many other countries for less than a dollar a pill, it cannot be sold in the US without going through a lengthy and expensive approval process. Possible solutions to prevent similar price increases in the future could be to create laws that limit price increases on drugs without patents on them or to increase the supply of medications sold in the US by allowing some sort of reciprocal approvals with countries that have strong regulatory systems in place.  A senate committee is requesting documents and information relating to the pricing of Daraprim and several other medications and there are lawmakers pushing to create legislation that would limit price hikes.

Another enterprising company seems to have found their own solution to the problem of the high cost of Daraprim – creating a cheaper alternative. Imprimis Pharmaceuticals has stated that they will produce a substitute drug that will be priced as low as $99 for a 100 pills.  The alternative drug isn’t a generic version of Daraprim, but rather a compounded drug that combines two FDA approved drugs (pyrimethamine, the only ingredient in Daraprim, and leucovorin) that are often used together.  The compounded drug would not be FDA approved, but doctors can prescribe it specifically for a patient based on the rules governing compounded medications.

It isn’t as elegant as having another FDA-approved supplier of Daraprim, but it seems like a viable work-around for many patients.  It also seems like satisfactory justice for the price of 60-year-old pyrimethamine drugs to end up cheaper in the US after they were hiked up to such high levels.

Handwashing is effective at fighting disease – so why doesn’t it happen more?

By ThinkReliability Staff

Global Handwashing Day is October 15. It’s very clear that handwashing can prevent disease – one study showed that it resulted in a 30% reduction in episodes of diarrhea; another study showed it could reduce the risk of respiratory infections by 16%. Yet proper handwashing is still not happening in many places. It’s estimated that the rate of handwashing is less than 20% in some developing countries.

There are multiple reasons that effective handwashing may not be occurring. We can look at these issues, as well as some of the solutions that have been suggested or implemented to increase the rates of handwashing, in a Cause Map, or visual root cause analysis. This method, like other problem-solving methods, involves three steps to define the problem(s), analyze the issues that may cause the problems, and brainstorm solutions that will reduce the risk of the problem(s) recurring.

In Cause Mapping, the problem is defined as the impact to an organization’s goals. In this case, the goals are broad and impact the population of most of the world. The risks of increased disease (particularly diarrhea and respiratory infection) impact the public safety goal. Contamination of handwashing water is an impact to the environmental goal.

The cause-and-effect analysis begins with the impacted goals. Asking “why” questions allows us to determine the causes that resulted in the impacted goals (or effects). It has been established (by the previously mentioned studies, as well as others) that the public safety impacts of increased risk of disease result from ineffective handwashing (or no handwashing at all).

Proper handwashing involves 3 things: clean water, soap, and time. Lathering with soap for about twenty seconds detaches oils and microbes from the skin and water washes it away. Removing any one of these things results in an ineffective wash, and there are multiple reasons why this could occur.

If no soap is available, washing won’t be able to remove disease-causing microbes. Obtaining soap may be difficult due to cost or availability. If soap is obtained, it may be eaten by goats (seriously, goats eat everything) or may not be used if it doesn’t smell good. Solutions suggested include making a protective cover to protect the soap from goats, finding less expensive soap supplies, or creating hand soap out of laundry soap and water. Hardening soap in the sun can help it last longer. Some groups have also started developing nicer-smelling, inexpensive soap or allowing donation of leftover pieces of soap from hotel use.

Even with soap, washing for a period of time (about twenty seconds) is required to give it time to fully remove germs and oils. Various versions of handwashing jingles (songs about the importance of handwashing that last at least the required amount of time) have been developed and are being spread across many areas of the world.

Lastly, even if handwashing involves lathering with soap for at least twenty seconds, if the soap is then rinsed off using contaminated water, the contamination will spread to the just-washed hands. In areas where there is no running water, water used for handwashing can be contaminated when dirty hands or ladles are dipped into the water. To reduce the risk of contamination, many areas use plastic containers that contain a tap that drips out water to use for handwashing.

Even with these difficulties, handwashing remains the most effective, inexpensive way to prevent disease across the globe. No matter where you live, it’s important to wash your hands properly and frequently, to fight the spread of disease.

To view the Cause Map and solutions related to this issue, click “Download PDF” above. Or, click here to read more.


Why You Will Experience a Diagnostic Error

By ThinkReliability Staff

On September 22, 2015, the Institute of Medicine released a report entitled “Improving Diagnosis in Health Care“. The report was the result of a request in 2013 by the Society to Improve Diagnosis in Medicine to the Institute of Medicine (IOM) to undertake a study on diagnostic error. The tasking to the committee formed by the IOM matched the three step problem-solving process: first, to define the problem by examining “the burden of harm and economic costs associated with diagnostic error”; second, to analyze the issue by evaluating diagnostic error; third, to provide recommendations as “action items for key stakeholders”.

The burden of harm determined to result from diagnostic errors is significant. Diagnostic errors are estimated to contribute to about 10% of hospital deaths, and 6-17% of hospital adverse events, clearly impacting patient safety. Not only patient safety is impacted, however. Diagnostic errors are the leading type of paid malpractice claims. They also impact patient services, leading to ineffective, delayed, or unnecessary treatment. This then impacts schedule and labor as additional treatment is typically required. The report found that, in a “conservative” estimate, 5% of adults who seek outpatient care in the United States experience a diagnostic error each year and determined that it is likely that everyone in the US will likely experience a meaningful diagnostic error in their lifetime.

The report also provided an analysis of issues within the diagnostic process (to learn more about the diagnostic process, see our previous blog) that can lead to diagnostic errors. Errors that occur at any step of the diagnostic process can lead to diagnostic errors. If a provider receives inaccurate or incomplete patient information, due to inadequate time or communication with a patient, compatibility issues with health information technology, or an ineffective physical exam, making a correct diagnosis will be difficult. Ineffective diagnostic testing or imaging, which can be caused by numerous errors during the process (detailed in the report). Diagnostic uncertainty or biases can also result in errors. However, not all errors are due to “human error”. The report asserts that diagnostic errors often occur because of errors in the health care system, including both systemic and communication errors.

When diagnostic errors do occur, they can be difficult to identify. The data on diagnostic errors is sparse due to both liability concerns as well as a lack of focus historically on diagnostic errors. In addition, there are few reliable measures for measuring diagnostic errors, and diagnostic errors can frequently only be definitely determined in retrospect.

The report identifies eight goals for improving diagnosis and reducing diagnostic errors that address these potential causes of diagnostic errors. These goals are presented as a call to action to health care professionals, organizations, patients and their families, as well as researchers and policy makers.

To view a high-level overview of the impacts to the goals, potential causes and recommendations related to diagnostic error presented in a Cause Map, or visual root cause analysis, click on “Download PDF” above. To learn more:

To read the report, click here.

For an overview of the diagnostic process, click here.

For an example of a diagnostic error with extensive public health impacts, click here.

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.

Attack on Hospital Staff Indicates Systematic Safety Issues

By ThinkReliability Staff

On July 13, 2015, a security counselor at a Minnesota psychiatric hospital was attacked and seriously injured by a patient. Even one injury to an employee is highly undesirable and should initiate a root cause analysis in order to reduce the risk of these types of events recurring. In the case of this hospital, this employee injury is one in a long line. In 2014, 101 staff injuries were reported at the hospital. From January to June of 2015, 68 staff injuries were reported. Clearly this is an extensive – and growing – problem at the site. According to Jennifer Munt, a spokeswoman for a union which represents 790 workers, “Workers at the security hospital feel like getting hurt has become part of the job description.”

An incident like this one can be captured within a Cause Map, or visual root cause analysis. The first step in the method is to define the problem in a problem outline. The problem outline captures the what, when and where of an incident, as well as the impact to the goals. Another important piece of information that is included is the frequency of similar events. Capturing the frequency helps provide the scope of the problem.

Understanding the details for one specific incident will likely reveal systematic issues that are impacting other similar incidents. That is definitely true in this case. Beginning with an impacted goal and asking “why” questions results in developing cause-and-effect relationships. Each cause that is determined to have contributed to an issue can lead to a possible solution. Each cause added to the Cause Map provides additional possible solutions, which, when implemented, can reduce the risk of future similar incidents.

In this case, we begin with the employee safety goal. An employee was seriously injured because of an assault by a patient at the hospital. The assault resulted from two causes, which were both required and so are joined with an “AND”. First, violent patients are housed at the facility. There were no other facilities available for the patient and the hospital is required to admit mentally ill county jail inmates because of a Minnesota law (known as the “48 hour rule” because of the time limit on admissions).

Second, clearly there was inadequate control of the patient. According to the union, limitations on the use of restraints, which are only allowed when a patient poses an “imminent risk”, mean that staff members feel that they cannot restrain patients until after they’ve been threatened – or assaulted. The union also says that inadequate staffing is leading to the increase in assaults. Specifically, union officials say at least 54 more staff members are required for the facility to be fully staffed.

The issues have caught the attention of state safety regulators and government. Multiple solutions have already been incorporated, including use of cameras, a separate admissions unit for new patients and protective equipment for staff. Additional staff is also being hired. The patient involved in the attack is isolated and under constant supervision. There’s no word yet on whether the use of mobile restraints, as requested by the union, will be allowed.

Says Jaime Tincher, Chief of Staff for Minnesota Governor Mark Dayton, “These are important first steps; however we will continue to assess what additional resources are needed to improve safety and treatment at this facility.” No less would be expected for ongoing issues that have such a significant impact on employee safety.

Cuba Eliminates Transmission of HIV from Mother to Child

By ThinkReliability Staff

On June 30, 2015, the World Health Organization (WHO) declared mother-to-child transmission (MTCT) of HIV in Cuba eliminated. Clearly, this is fantastic news. Says Dr. Margaret Chen, WHO Director-General, “Eliminating transmission of a virus is one of the greatest public health achievements possible. This is a major victory in our long fight against HIV and sexually transmitted infections, and an important step towards having an AIDS-free generation.” The fight against HIV continues, with a global target of less than 40,000 new child infections per year by 2015.   (In 2013, there were 240,000 children born with HIV worldwide.) It’s hoped that the progress made in Cuba can be extended to the rest of the world.

How did Cuba do it? Root cause analysis can be used to determine causes of positive impacts as well as negatives. Here we will use a Cause Map, or visual root cause analysis, to determine the causes that resulted in Cuba being declared free of MTCT of HIV. Instead of defining the “problem” in a problem outline, we will define the success using the same format. In this case, the elimination of transmission of HIV from mother to child is the success we’ll be looking at. This success impacts goals as well, though positively. The child safety goal is impacted because it is now very rare (only 2 in 2013) for children to receive HIV from their mothers. The maternal safety goal is impacted because mothers are receiving effective treatment for HIV. Other goals are impacted because of the decreased need for services for children who might otherwise have been infected with HIV.

Beginning with an impacted goal, we can ask Why questions. Why is it rare for children to receive HIV from their mothers? Because the risk of passing HIV from mother to child has been lessened. Why? Because when children are born to HIV-infected mothers, there is decreased exposure to infants from their mother’s bodily fluids, and both mothers and children are being treated effectively for HIV. Decreased exposure to bodily fluids has been accomplished by the use of Cesarean sections and substitution for breastfeeding. Effective HIV treatment results from awareness of the presence of HIV infection from testing performed by healthcare providers, seen as part of a five-year initiative that gave universal healthcare coverage and access. That same access allowed treatment for infected moms and their children with antiretrovirals.

Although this Cause Map is presented as a positive impact to the goals, it could also be presented as an analysis of the problem of HIV transmission from mother to child. The causes would be baby’s exposure to mom’s body fluids, and lack of effective treatment due to lack of knowledge of infection and/or lack of access. The solutions to that Cause Map are the causes presented here in the positive Cause Map. (For example, use of Cesarean sections and substitutions for breastfeeding are solutions to the cause of baby being exposed to mom’s body fluids.)

In order to receive validation from WHO of the elimination of MTCT of HIV, Cuba had to meet very specific indicators for a defined period of time. These indicators do not just measure the overall success of the program (impact indicators), but also measure the success of the initiatives meant to achieve those goals (process indicators). Impact indicators included reducing MTCT of HIV to less than 50 cases per 100,000 live births, less than 5% in breastfeeding populations, and less than 2% in non-breastfeeding populations for at least 1 year. Process indicators included more than 95% of all pregnant women receiving at least one antenatal visit, more than 95% of pregnant women knowing their HIV status, and more than 95% of HIV-positive pregnant women receiving antiretroviral drugs for at least 2 years.

With implementation of similar initiatives across the world, it is hoped that MTCT of HIV will continue to decrease rapidly.

To view the outline, Cause Map, and indicators, click on “Download PDF” above. Click here to read the release from the WHO.