Fighting Polio in India

By ThinkReliability Staff

On February 25, 2012, the World Health Organization removed India from the list of countries with active transmission of endemic polio.  This leaves three countries – Nigeria, Pakistan and Afghanistan – that are still struggling to eradicate polio from their population.  (See our previous blog for a discussion of the difficulties these countries are facing.)   India is an example of a remarkable success story made possible by hard work and meticulous planning.  In 2009, India reported the most polio cases of any country in the world – 741.  By the next year, the country reported on 42.  The last case of polio in India was reported on January 13, 2011.

We can use root cause analysis to determine causes of problems, and to learn from the issues of others.  We can also use it to learn from the successes of others.  Here we can use “success mapping” to create a Cause Map, or visual root cause analysis, of a successful outcome – in this case, the eradication of polio from India.  The steps of success mapping are the same as for incident mapping.  In this case, the public health goal was impacted – positively – by the absence of polio cases since 2011 in India.

We begin with the impacted goal, and ask “Why” questions.  The absence of polio cases in India is due to a successful vaccination campaign – covering more than 99% of children.  The successful program is due to a comprehensive, detailed vaccination plan, which we can lay out in a process map.  (To read more about India’s polio vaccination campaign, please see the Global Polio Eradication Initiative’s Website.)

The process for successful vaccination addresses some of the common problems with vaccination programs, which are still seen in the remaining endemic countries.  Notably, access to children is a major difficulty with vaccination programs.  In India, local volunteers canvass neighborhoods and determine the number of children in each home to provide vaccination workers with a number of children to look for and vaccinate.   Vaccination teams are also provided special tracking booklets for newborns, to ensure that any children that were not previously accounted for are added to the total.

There are many reasons that children are unable to be vaccinated.  Aid workers track the specific reason for each child that is not vaccinated and, depending on the reason, an appropriate follow-up team is sent to the house later on the same day and, if still unsuccessful, later in the week.  Follow-up teams include a community influencer if a parent refuses to vaccinate the child and a medical officer if a vaccination is not given because a child is ill.

Because some children are not found at home, transit teams were formed.  These teams vaccinate children at major intersections and transit points, such as train and bus stations.  To ensure full coverage (and that each child is vaccinated only once), children’s fingers are marked after they have received vaccinations.

It is hoped that some of these ideas can also be used by the vaccination teams in the remaining countries that have endemic polio and to ensure that polio does not return to countries that have already been removed from the list.  When ideas are successful at one site, other sites may be able to benefit from them as well.

However, a great process means nothing if you don’t have a team of dedicated workers.   As stated by India’s Prime Minister, “The real credit goes to the 2.3 million volunteers who repeatedly vaccinated children even in the most remote areas, often in very bad weather conditions. I commend each one of them for their dedication, commitment and selfless service.”  We second that commendation, and thank you for helping reduce the risk of this horrible disease.

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

Only 3 Countries Remain with Endemic Polio

By ThinkReliability Staff

Polio is a horrible, crippling disease.  According to the World Health Organization (WHO), of the children who contract polio, 1 of 200 will be irreversibly paralyzed.  Of the children who are paralyzed, 5 to 10% will die because their breathing muscles are paralyzed.  The Global Polio Eradication Initiative was formed in 1988.  That year, more than 350,000 people were paralyzed.  So far in 2012 only 181 cases have been reported.  Obviously this is a huge success, but unfortunately, it’s not quite enough.  As Centers for Disease Control & Prevention (CDC) Director Dr. Frieden states “If we fail to get over the finish line, we will need to continue expensive control measures for the indefinite future…More importantly, without eradication, a resurgence of polio could paralyze more than 200,000 children worldwide every year within a decade.”

Because polio cannot live outside the body for long periods of time (unlike most diseases) it can be eradicated.  The only human disease that has been completely eradicated is smallpox.

On February 25, 2012, India was removed from the list of endemic countries, leaving only three countries where polio is endemic: Afghanistan, Nigeria and Pakistan.  Eradication in these countries continues to be difficult for various reasons.  We can look at some of the causes of why eradication has been difficult in these countries and ongoing solutions to these difficulties by analyzing the issue in a Cause Map, a visual form of Root Cause Analysis.

We begin with the impacts to the goals.  Public safety is impacted because of the risk of death and paralysis.  Public services are impacted due to the risk of contracting polio.  Additionally, the compliance goal is impacted because children are not receiving full vaccinations against polio.

There are myriad reasons for children not receiving full immune protection from vaccination against polio.  First is the difficulty finding and accessing children.  Many children in endemic areas are nomadic or homeless.  The use of “transit teams” – vaccination teams stationed at transportation stations and large crossings – aims to increase vaccination of these children.  Children are marked after they receive vaccines, to ensure the vaccines are not repeated and to allow tracking of the success of the program.  In many of the endemic areas, children are inaccessible to vaccination teams due to conflict or violence in these areas.  In some areas vaccination teams are blocked by local governments or even subject to violence.  Some religious and local government leaders do not support the vaccination program, or the makeup of the vaccination teams.  Outreach campaigns aim to reach the public, community and religious leaders.  The GPEI, WHO and CDC are trying to work with governments and religious organizations to increase acceptance of the vaccines.  The creation of small scale immediate immunization response strategies aims to allow fast response when a previously inaccessible area becomes accessible, to maximize immunization during that time.

Some parents will not allow their children to be vaccinated.  In many cultures, women will not open the door to men.  Vaccination teams will generally include at least one woman to help increase acceptance from parents.  Parents are also reluctant to vaccinate newborns, or children who are sick or sleeping.  The importance of vaccinating these children is being added to outreach information and polio hotlines are being created to attempt to provide information to reluctant parents.  Because at least four doses of the polio vaccine are required to fully protect against the disease, these issues are magnified.  Permanent polio teams in the endemic areas aim to maximize the immunization coverage and attempt to eradicate this disease once and for all.

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

NYC Hospital Unexpectedly Evacuated During Sandy

By Kim Smiley

On October 30, 2012, power outages forced evacuation of a New York City hospital amidst the onslaught of Hurricane Sandy.   All 217 patients in the hospital to had moved, including 20 infants staying in the neonatal intensive care unit.

This incident can be analyzed by building a Cause Map, an intuitive format for performing a root cause analysis.  The first step in the process is to fill in an Outline that lays out the basic background information and also identifies the impact to the goals.  In this example, the safety goal is clearly impacted because it is risky to evacuate patients during a hurricane.  Although the potential for injury was very real, no one was hurt during the evacuation and the hospital staff did an amazing job of carrying patients down darkened stairwells and ensuring basic life support remained stable.  The customer service goal is also worth considering since the unexpected evacuation received a large amount of negative publicity.

After the Outline is completed, the next step is to ask “why” questions to add Causes to the Cause Map.  Why were patients at risk?  This occurred because the hospital had to be evacuated because it lost power and the backup power generators failed.  Why the generators failed hasn’t been identified yet, but there is speculation that the age of the equipment may have played a role. It’s also possible that the location of the generators might be factor since a number of hospital building were flooded by ten feet of water.  Electrical service was lost because New York City was hit hard by Hurricane Sandy and saw unprecedented flooding and strong winds.  This wasn’t an unexpected impact of the storm, but the hospital did not expect the generators to fail, especially so quickly.  The patients were also at risk because the hospital had many patients in critical care units that required life support systems and the patients were evacuated under dangerous conditions, both inside and outside the hospital.  At the time of the evacuation the hospital had lost power and patients were being carried down stairs lit by flashlights.  Some patients were bought down 16 flights of stairs.  The evacuation also occurred during the hurricane so the conditions during the drive to a new faculty were potentially dangerous.  The evacuation occurred during the hurricane, as opposed to before the storm hit, because the hospital assured the city that it was prepared and could ride out the hurricane.

This issue is still being investigated, but once all the facts are known solutions can be developed and implemented to help ensure that patients aren’t forced to evacuate under similar adverse conditions.

Click on “Download PDF” above to see a high level Cause Map of this issue.

Update: Contaminated Injections Have Now Killed 29

By ThinkReliability Staff

In a previous blog, we discussed deaths related to fungal meningitis believed to have resulted from fungal contamination of a compounded drug used as an injection for back pain.  Sadly, since our last post, the numbers of deaths and injuries has risen.  So far, 29 patients have been killed and more than 360 have been sickened by the infected injections.  Because drugs from the three affected lots were injected for pain relief to approximately 14,000 patients, investigators expect to see many more cases in the coming months.  Some of these patients received injections in other joints, so they are suffering from peripheral joint infection, which is less severe and less likely to lead to death than fungal meningitis.

We can update the Cause Map, or visual root cause analysis, which was started in our previous blog.  Specifically, as investigators are able to provide more detail about the case, we can update causes and validate them with evidence.  We are also able to update the outline as more patient deaths and sickness are discovered.

Investigators have verified that the source of the fungal contamination was the compounding company.  They noted in investigations that the clean room was contaminated due to lack of control of the humidity and temperature.  It appears that the air conditioning was shut down at night, resulting in environmental issues. Additionally, sterilization at the company was found to be inadequate.  Sterilization procedures were not followed, and sterilization equipment was found to be contaminated, possibly because it was not properly tested.  Once the contamination made it into the drug, the drug was shipped without the company knowing of the contamination, because shipping on some lots took place before the results of sterility testing were received.

The Massachusetts Department of Health has announced increased oversight of compounding companies, including annual inspections.  A bill has been introduced in Congress for FDA regulation of compounding companies that produce larger quantities of drugs for mass distribution, as appears to be the case in this instance.  It also recommends requiring compounded drugs to contain a label stating they have not been FDA-approved.  Although the compounding company responsible for the contamination has been closed down, it is hoped that a higher level of regulation will reduce the possibility of similar deaths in the future.

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