Patient Safety Blog

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.

Root Cause

Only 3 Countries Remain with Endemic Polio

November 16, 2012 Angela Griffith

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.

Root Cause

Manifestation of Poor Glycemic Control Part 2

October 18, 2012 Angela Griffith

In a previous blog, we discussed how poor glycemic control can result in hyperglycemia which could lead to nonketotic hyperosmolar coma. Diabetic ketoacidosis, if resulting from poor glycemic control within a hospital setting, is another hospital-acquired condition as determined by Medicare & Medicaid, meaning that hospitals will not receive additional payment for cases when this condition is acquired during hospitalization. Like nonketotic hyperosmolar coma, diabetic ketoacidosis can have a significant impact on patient safety and can be investigated within a Cause Map, or a visual root cause analysis.

The impacted goals for a hospital resulting from hospital-acquired diabetic ketoacidosis are very similar to those for nonketotic hyperosmolar coma. Patient safety is impacted due to an increased risk of death, which can also result in a provider being a “second victim. This is a “no-pay” hospital acquired condition, which is estimated to cost $42,974 per case. According to the Centers for Medicare & Medicaid Services (CMS), in 2007 there were 11,469 cases of hospital-acquired diabetic ketoacidosis, resulting in a total cost to the healthcare system of almost half a billion dollars.

According to a study published in the International Journal for Quality in Health Care, diabetic emergencies, including nonketotic hyperosmolar coma, increases the risk of patient death (from 9% to 16%), length of patient stay (from 7 to 14 days) and treatment requirements. The costs associated with nonketotic hyperosmolar coma (greater than $114 million in the US in 2007, according to CMS) are no longer reimbursable when the condition is acquired in the hospital. Additionally, patient death due to hospital-acquired conditions can result in a second victim – the healthcare provider(s). Additionally, this diagnosis results in increased stay and treatment requirements.

Beginning with the impacted goals and asking “Why” questions, we quickly determine that diabetic ketoacidosis, like nonketotic hyperosmolar coma, results from uncontrolled hyperglycemia. Rather than perform the same analysis of causes of hyperglycemia (which, if we’re doing our job right, should result in the same cause-and-effect relationships), we can link to the analysis shown in our previous blog. However, for diabetic ketoacidosis, we also have a cause of dehydration. Since this was not a cause previously analyzed, we will add to this portion of the Cause Map.

Patient dehydration can result from a medication that increases fluid loss, an underlying medical condition, or inadequate water intake. Inadequate water intake can result from a patient’s limited access to water, such as a patient who is bedridden and is not provided adequate water from a caregiver, or the patient feels too ill to drink, or the patient is unable to drink, due to incapacitation, confusion, restraints or sedation. A combination of these causes may also occur.

Because of the importance of preventing these conditions resulting from hyperglycemia and dehydration, every effort should be made to prevent these outcomes from occurring.

Two other conditions are considered hospital-acquired manifestations of poor glycemic control, diabetic ketoacidosis and hypoglycemic coma. In future blogs, we will discuss the causes of these issues, and suggested solutions to reduce the risk of these types of incidents. It is recommended that an individualized insulin plan be used, rather than a sliding scale, to ensure blood glucose levels are kept at or below 110 mg/dL. A specific glycemic management team, which carefully coordinates medical nutritional therapy with insulin control, can also reduce the risk of glycemic events. Patients who are found to have an insulin deficiency should be treated with intravenous insulin.

Because 20-30% of diabetic ketoacidosis cases are estimated to be the initial presentation of previously undiagnosed diabetes, some experts recommend testing the glucose levels of all children who have not been diagnosed with diabetes, and all patients who are vomiting or require intravenous hydration. To reduce the risk of dehydration, patient’s fluid intake should be tracked and any patients who are unable to drink should have intravenous fluids.

Nonketotic hyperosmolar coma and diabetic ketoacidosis are two hospital-acquired events that result from hyperglycemia. The remaining hospital-acquired manifestation of poor glycemic control, hypoglycemic coma, will be covered in a future blog.

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

Root Cause

Manifestation of Poor Glycemic Control Part 1

October 12, 2012 ThinkReliability Staff

Nonketotic hyperosmolar coma resulting from poor glycemic control within a hospital setting is now considered a hospital-acquired condition by Medicare & Medicaid, meaning that hospitals will not receive additional payment for cases when this condition is acquired during hospitalization. Because of the severity of the impact of this condition, its implications and causes should be carefully studied to determine ways to reduce the risk of this condition being acquired during a hospital stay.

We can look at the impacted goals for a hospital and the potential causes for this condition, in a visual root cause analysis or Cause Map. To perform a Cause Mapping analysis, we will first determine the impacts of a given condition on an organization’s goals, then develop cause-and-effect relationships to diagram the causes that result in the condition.

To analyze this issue, we begin with an impacted goal and ask “Why” questions. In this case, we are looking at the impact to the patient safety goal becaue of the increased risk of patient death due to nonketotic hyperosmolar coma, which is caused by uncontrolled hyperglycemia (high blood glucose). Associated infection, medication that interferes with glucose absorption, and insulin deficiency can all contribute to hyperglycemia. Insufficient knowledge of providers about glycemic control can result in diabetic patients being given medications that interfere with glucose absorption, or in inadequate control of diabetes with insulin in the hospital setting.

The study referenced above also found that insufficient staffing, which may result in insufficient backups/checks of staff, use of workarounds, and ineffective communication between the team, leading to insufficient tracking of glycemic control. Providers may also be unaware of a patient’s diabetic status, due to poor record keeping or communication. Inadequate insulin therapy can also contribute to hyperglycemia. Specifically, medication errors involving insulin (see our medication error Cause Map), fear of hypoglycemia (which may result in fear of aggressive insulin therapy), and failure to adjust insulin for diet or other factors, including age, renal failure, liver disease, can result in an all too common “one size fits all” linear sliding insulin scale providing inadequate results.

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

Working to Eradicate A Painful Parasite

September 7, 2012 Kim Smiley

The lifecycle of the Guinea worm is the stuff of nightmares. This parasite is ingested by a host as larvae, mate and mature inside the host and then the adult female painfully emerges to lay her eggs. The adult female is between two to three feet long and the thickness of a spaghetti noodle. The only way to get rid of the parasite is to wrap it around a stick and slowly pull it out, a process that takes several weeks or even months.

Individuals who are infected by this parasite can suffer for months, making it difficult to work and feed their families. There is no immunity to Guinea worms so it’s possible for people to suffer year after year if they continue to ingest the larvae of the Guinea worms. There is also no drug to treat Guinea worm disease and there is no vaccine that prevents infections.

But there is hope in the fight against this excruciating disease. The number of cases of Guinea worm disease has decreased dramatically. In 1986 there were an estimated 3.5 million cases of Guinea worm disease spread across 21 countries in Asia and Africa. In 2011, there were only 1,058 reported cases of Guinea worm disease in four African countries.

How was this possible? The first step in answering that question is to understand more about the disease. The problem of Guinea worm disease can be illustrated by building a Cause Map, an intuitive root cause analysis format. By asking “Why” questions, causes can be added to the Cause Map and the problem can be analyzed. Why are people getting the disease? People are drinking water that is contaminated with copepods, also called water fleas, which are infested with larvae of Guinea worms. There is also typically no other supply of safe drinking water and the water wasn’t treated or filtered prior to consumption.

Painful blisters form when the female Guinea worm emerges from the body and people put their sores into the same water used for drinking (because it is usually the only water available) to help relieve the burning sensation. The female Guinea worm then releases hundreds of thousands of guinea worm larvae once she senses water. Guinea worm larvae is eaten by the water fleas. The infected water fleas are small and ingested along with the water, which restarts the whole process.

This process had been going on for thousands of years, affecting millions and millions of people. Its remains have even been found in Egyptian mummies. But simple changes have nearly eliminated the disease. In fact, Guinea worm disease is predicted to be the first human disease ever eradicated without a vaccine and only human disease to be eradicated other than small-pox.

Relatively simple changes have made all the difference in the world. People were educated about how to prevent the disease. Millions of straws with filters were handed out to villagers to strain out the infected water fleas and prevent the parasite from entering the body. Efforts were also made to treat water with larvicide and provide access to uncontaminated drinking water.

Without new hosts, the Guinea worm larvae died. Once the lifecycle was broken, the disease disappeared from many regions. There are now only four countries that reported any cases of the disease last year, the vast number being in war torn South Sudan where public health efforts have been difficult to sustain.

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

Consumption of Small Cigars Increases

August 9, 2012 Kim Smiley

A study by the CDC has found a decrease in cigarette smoking, but a corresponding increase in the use of other tobacco products. Cigarette smoking declined 33% between 2000 and 2011 which would be cause for celebration except for the fact that use of other kinds of tobacco grew by 123%. This seems to be an example of unintended consequences where the attempt to control one problem changed behavior in an unexpected way.

A Cause Map, or visual root cause analysis, can be used to help explain this situation. Building a Cause Map can illuminate the cause-and-effect relationships between the different factors that contributed to an incident. To begin a Cause Map, the impacts to organizational goals are determined and then “why” questions are asked to add Causes. In this example, we’ll focus on the increase in the use of small cigars since they are the tobacco alternative most similar to cigarettes. We’ll also focus on the Safety Goal since public health is affected by the increasing use of small cigars, although there are certainly other issues such as missed tax revenue worth considering in a more detailed Cause map.

Why is the risk to public health increasing? This occurs because more people are using small cigars and they have similar health risks to cigarettes because they contain the same toxic chemicals. Why are more people using small cigars? Small cigars smoke similarly to cigarettes, are far cheaper than cigarettes and can taste better.

Small cigars are slightly larger than cigarettes, but are similar enough in size to provide a similar smoking experience. They are far less expensive than cigarettes because they are in a different tax category because of their slightly larger size and the fact that not all tobacco products are equally taxed. The price difference is significant; small cigars may cost as little as $1.40 a pack while cigarettes sell for $4 or $5 a pack since they are highly taxed to discourage smoking.

Cigars can also taste better because manufacturers are allowed to add flavorings such as grape and chocolate to small cigars, but they are not allowed to add them to cigarettes. The Food and Drug Administration has regulations that bar adding flavoring to tobacco, but these do not apply to cigars and pipe tobacco.

From 2010 to 2011, the overall use of smoked-tobacco decreased by less than 1%.
It appears that attempts to discourage smoking cigarettes with high taxes just pushed some people into buying cheaper alternatives. One potential solution to this issue would be to equalize the taxes and regulations on all types of tobacco.

To view a high level Cause Map of this example, click on “Download PDF” above.

The Low Survival Rate of Pancreatic Cancer

July 27, 2012 Kim Smiley

Sally Ride, the first US woman in space and a national hero, died after a 17-month battle against pancreatic cancer on July 21, 2012. Pancreatic cancer is a particularly deadly cancer with only a 6% five-year survival rate. This disease also affects many people. In 2010 alone, an estimated 43,000 people in the US were diagnosed with pancreatic cancer.

The reasons that pancreatic cancer is so deadly can be explored by building a Cause Map, a visual root cause analysis. The first step in building a Cause Map is outlining the problem which includes defining how the problem impacts the organizational goals. In this example, the primary goal considered is the impact to the safely goal since pancreatic cancer has such a low survival rate.

In order to build the Cause Map, “why” questions are asked and the answers are added to the Cause Map. Why does pancreatic cancer have such a low survival rate? The survival rate is low because the cancer has usually spread beyond the pancreas by the time it is detected and pancreatic cancer is difficult to treat. The cancer has typically spread before detection because there are very few symptoms in the early stages of the cancer and any symptoms that do exist are usually vague, like aches and pains that could easily be attributed to other illnesses. There is also no screening test like there are for breast or prostate cancer to detect pancreatic cancer at this time.

Pancreatic cancers are difficult to treat for several reasons. First, pancreatic cancers are resistant to chemotherapy. The best course of treatment is typically removal of the tumor, but many cases are caught too late for the tumor to be removed because the cancer has usually spread by the time it is detected.

Researchers are working on improving the survival rate for pancreatic cancer. There are some promising studies that show it may be possible to develop a screening test that could detect pancreatic cancer at earlier stages, which could significantly improve the chances for survival.

To view a high level Cause Map of this issue, click on “Download PDF” above.

Medical Laboratory Errors

June 28, 2012 ThinkReliability Staff

Surprisingly, many of what are considered laboratory errors do not actually occur in the lab. But errors related to laboratory testing can negatively impact patient care. We can look at the impacts and causes of errors related to diagnostic testing in a Cause Map, which allows us to visually diagram cause-and-effect relationships.

We begin this type of root cause analysis by determining the impacts to the organization’s goals. In this case, because we want to consider all possible sources of diagnostic errors in a proactive analysis, we will look at the generic goals for an organization that provides healthcare. Diagnostic errors can cause an impact to the patient safety goal because of the risk of impact to patient treatment. Employees’ abilities to do their job is impacted because they may be receiving incorrect information from lab testing. There is a risk of impact to the patient’s treatment, which is an impact to the patient services goal. Additionally, there is a risk of performing unnecessary treatment as a result of incorrect testing results, which could impact both the property and labor goals.

Once we have determined the impacts to the organization’s goals (and there may be more impacts for specific incidents involving diagnostic testing errors), we can ask “Why” questions to determine the causes that result in these impacts. We will begin with the patient safety goal impact. The patient safety goal is impacted because of the risk of an impact to a patient’s treatment. This includes the possibilities of a risk of delayed treatment, risk of not receiving needed treatment, and a risk of unnecessary treatment. Delayed treatment can occur from a delayed diagnosis, which could result from either delayed or incorrect testing results.

Delay of testing results can be caused by delayed reporting of results, potentially due to a lack of time requirement for reporting results and/or a lack of tracking these results. A possible solution to delayed reporting of results can be to implement a standardized process for reporting results, which may include time limits or guidelines for reporting results.

Incorrect treatment – whether that is not getting needed treatment or receiving unneeded treatment – can result from an incorrect diagnosis. An incorrect diagnosis can result from an incorrect assessment of diagnostic testing. An incorrect assessment can result from either an incorrect interpretation of laboratory test data or incorrect data from the lab testing.

Incorrect interpretation of lab testing can result from reports that are difficult to interpret, either due to a confusing layout or illegibility. A solution to this is to have a standardized reporting form. Other potential causes of incorrect interpretation include confusion of verbal reporting (such as over the phone) or results not being interpreted by a specialist. Solutions that can reduce this confusion include providing reports electronically when available or repeating results when provided verbally, and making lab experts available for interpretation.

Three main reasons that incorrect data is provided as a result of lab testing is that the specimen is associated with the wrong person, possibly because a patient is misidentified, a specimen is mislabeled, or information is entered incorrectly into the computer. Possible solutions are to use two patient identifiers and label the specimen in the presence of the patient.

Contaminated specimens can also cause incorrect testing results. Specimens can be contaminated at collection, handling, or testing. Any of these issues can be caused by insufficient quality control. The risk of contamination can be minimized by a standardized quality control procedure.

Lastly, incorrect diagnostic data can result from the wrong test being performed. This could occur due to equipment failure, an incorrect entry into the computer, or the wrong test being ordered. More details about any specific incident can be added to the Cause Map based on evidence gathered in the course of an investigation.

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

Fixes Don’t Have to be Complicated

September 28, 2011 Kim Smiley