Tag Archives: cause mapping

Root Cause

Baby Breastfed by Wrong Mom

By ThinkReliability Staff

After a newborn baby at a Minneapolis hospital was placed in the wrong bassinette, he was delivered to the wrong mother and breastfed.  Because breastfeeding can carry risks of transmission of communicable diseases the CDC recommends HIV and hepatitis testing after such events.

We can examine this incident – and what went wrong – in a visual root cause analysis, or Cause Map.  The Cause Mapping procedure begins by determining the impact to the organization’s goals.  In this case, the patient safety goal is impacted due to the risk of transmissible disease.  The hospital involved has stated there will be consequences to staff for not following hospital procedure.  This is an impact to the hospital’s employee impact goal.  The patient services goal is impacted because babies were switched (and apparently misplaced for some period of time) and because of the testing that the baby who was breastfed by the wrong mother will require.  The hospital will pay for the testing, which can be considered an organizational goal impact.

The analysis step of the Cause Mapping process begins with the impacted goals.  To continue the analysis, we ask “why” questions.  The patient safety goal is impacted because of the risk of disease.  The risk of disease is caused by being breastfed by the wrong mother.  This occurred because the wrong baby was brought to the mother,  the mother was breastfeeding, and the infant’s bands were not matched to the mother’s bands, although this was hospital procedure.  According to the hospital’s statement, “While hospital procedures require staff to match codes on the infant’s and mother’s identification bands in   order to prevent incidents like this, it appears these procedures were not followed in this case.”

The wrong baby was brought to the mother because multiple babies were kept in bassinettes in the nursery, and the baby had been placed in the wrong bassinette.  It is unclear what procedure was used to determine which bassinette the baby should be placed in, but the procedure was obviously ineffective.

The hospital has stated that its procedures will be reviewed.  Certainly the procedure to verify a baby’s wristband to a mother’s will be emphasized and retrained.  Additionally, matching of the baby’s wristband with a tag on the bassinette would reduce these types of issues.  Some hospitals have gone so far as to stop using nurseries where multiple babies are placed and instead keep the newborn in the mother’s room.  This also would reduce the risk of baby switching incidents.

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

Root Cause

A Tongue Tie Release Wrongly Performed in Case of Tongue Lesion Resection

By ThinkReliability Staff

A California hospital has been fined $50,000 – its fifth administrative penalty from the State since 2009 – for performing the wrong procedure on a 6-year-old boy.  The boy was supposed to receive a tongue lesion resection, but instead a tongue tie release was performed.

We can examine the issues that resulted in this incident within a Cause Map, or visual root cause analysis.  The first step in any analysis is to define what you are analyzing.  We begin with impacts to the organization’s goals.  In this case, we look at the impacted goals from the respect of the hospital.  First, the patient safety goal  was impacted due to an increased risk of bleeding, infection, and complications from anesthesia.  The compliance goal is impacted because performing the wrong surgical procedure on a patient is a “Never Event” (events that should never happen).  The organizational goal is impacted because of the $50,000 fine levied by the State of California.  The patient services goal is impacted because the wrong procedure was performed and the labor goal was impacted due to the additional procedure that was required to be performed.

The second step of our analysis is to develop the cause-and-effect relationships that describe how the incident occurred.  We can develop these relationships by beginning with the Impacted Goals and asking “why” questions.  For example, the patient safety goal was impacted because of the additional risk to the patient. The patient received additional risk because of the performance of an additional procedure.  An additional procedure was necessary because the wrong procedure was initially performed.

There are many causes that contributed to the wrong surgery being performed.  These causes are outlined in the  report provided by the California Department of Public Health.  In this case, there were several causes that likely resulted in the wrong procedure.  The Operative Report had the incorrect diagnosis – tongue tie – which would suggest that a release would be the appropriate procedure.  Additionally, the Anesthesia Record contained the wrong procedure (tongue tie release), possibly because the Pre-Anesthesia Evaluation originally noted that a tongue tie release was to be performed and was later corrected (by crossing out the incorrect procedure and writing in the actual procedure).

The type and site of surgery was not verified.  The surgeon who performed the surgery could not remember if a time-out had been performed, although there was a record of a time-out performed immediately prior to the surgical procedure.  Since the time-out was performed immediately prior to the procedure and the surgeon was unable to remember the proper procedure, the time-out was obviously ineffective.

The surgeon stated after the surgery that he believed that the tongue tie release surgery which was performed was indicated based on scar tissue that was found under the tongue.  The surgeon did not notice the lesion on the tongue during the surgery and no pre-surgical exam was performed by the surgeon.  Additionally, the surgical site was not marked (as the site of the correct, as well as the incorrect, surgeries were both within the patient’s mouth).

During the procedure, none of the other staff stopped the surgery as it was occurring.  However, given the proximity of the “correct” site to the “incorrect” site, it may have been difficult for the other staff to see what was going on.  The surgeon did note that the lesion removal should have created a sample, the lack of which was not noted by staff.

The surgeon involved in this case has indicated that he will be examining his patients prior to surgery in the future. Hopefully this incident will also serve as a reminder to all medical staff that in the case of a site that cannot be marked as per procedure, extra care should be taken to ensure the correct site is operated on and the correct procedure is performed.

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

Root Cause

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.

Root Cause

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.

Root Cause

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.

Root Cause

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.

Root Cause

Manifestation of Poor Glycemic Control Part 3

By ThinkReliability Staff

In previous blogs, we wrote about nonketotic hyperosmolar coma and diabetic ketoacidosis, which are both conditions related to hyperglycemia, or high blood glucose.  In this blog, we consider the last type of manifestation of poor glycemic control that, when it occurs in the hospital, is 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.  Hypogelycemic coma, along with nonketotic hyperosmolar coma and diabetic ketoacidosis, results from poor glycemic control within the hospital, but is caused by low blood glucose.

As we did with the other two manifestations of poor glycemic control, we can look at the impacted goals for a hospital and the potential causes and solutions for this condition in a visual root cause analysis or Cause Map.  The goals for hypoglycemic coma are the same to the other manifestations of poor glycemic control and include increased risk of patient death, length of patient stay and treatment needs.  The costs associated with hypoglycemic coma (greater than $7 million in the US from the 212 cases reported to CMS in 2007) are no longer reimbursable when the condition is acquired in the hospital.  There is also always the potential that a patient death can result in a second victim – the patient’s provider(s).

Hypoglycemic coma results from uncontrolled hypoglycemia, which can result from overtreatment with insulin, drug-induced hypoglycemia, drug interaction with insulin, decreased glucose production and/or loss of glucose.  Overtreatment with insulin was implicated in 90% of hypoglycemia cases in a recent study and can result from medication errors (see our analysis on medication errors in hospital settings),  or a failure to adjust insulin for diet or other factors.  Drug-induced hypoglycemia can result from administration of fluoroquinolones (the mechanism for this effect is unknown) and/or inadequate nutrition.  Drugs that interact with insulin may be administered to a diabetic patient if providers are lacking in knowledge about glycemic control.  Underlying disease or infection, such as chronic renal insufficiency, which was implicated in approximately 50% of hypoglycemia cases in the study, can result in decreased glucose production or loss of glucose.

As with the other types of manifestations of poor glycemic control, efforts must be made to prevent these types of incidents.  As suggested with hyperglycemic events, insulin plans should be individualized, accounting for all relevant factors related to glycemic control and diet.  Patients treated with insulin in the hospital should have their blood glucose levels monitored frequently, especially as insulin has been identified as a High-alert medication by The Joint Commission.   Any patients found unconscious should also immediately have their blood glucose levels measured.  Patient’s nutritional intake must be carefully monitored, especially for cases involving medications that might cause hypoglycemia.  Last but not least, controls and procedures involving drugs given to diabetic patients should be carefully controlled, due to the high potential and risk for interaction with insulin.

Two other conditions are considered hospital-acquired manifestations of poor glycemic control: nonketotic hyperosmolar coma and diabetic ketoacidosis.   In previous blogs, we discussed the causes of these issues, and suggested solutions to reduce the risk of these types of incidents.

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

Root Cause

Manifestation of Poor Glycemic Control Part 2

By ThinkReliability Staff

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

By 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.

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).

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.

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.

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

Root Cause

Contaminated Injections Kill 5

By ThinkReliability Staff

At least 35 patients have come down with rare fungal meningitis after an injection they received for back pain was contaminated with fungus. Five have died so far. Because of the severity of the disease and the long incubation period, more cases – and more deaths – are expected in the coming months.

We can examine the issues related to the fungal meningitis in a Cause Map, or visual root cause analysis. Documenting the causes visually can make a complex medical issue easier to understand. We begin with the impacts to the goals. The deaths and severe sickness are an impact to the patient safety goal. While we begin with the known cases, these numbers can be updated if more cases are discovered. The compounding company which prepared the injections has voluntarily surrendered its license, an impact to the compliance goal and has recalled 3 lots of the drug used in the injection (methylprednisolone acetate), which can be considered an impact to both the organizational and property goal. The extremely difficult treatment ahead of these patients (estimated to take months) is an impact to the patient services and labor goal. The contamination of the injection itself can be considered an environmental goal.

Once we have captured these impacted goals, we can begin with the focus of our investigation – the patient safety goal – and ask “why” questions to develop the cause-and-effect relationships that resulted in the disease. The patient deaths and sickness are due to contraction of fungal meningitis. These patients came down with fungal meningitis because fungus was introduced to their nervous system. The injections that the patients received for back pain were injected epidurally, which allows access to the nervous system, and were infected with aspergillus, a common fungi. More testing is being done to determine whether the contamination was in the drug within the injection, or the numbing agent or antiseptic wipes being used. Due to the widespread (across several states) outbreak, it is believed that the drug within the injection is to blame, but because of the seriousness of this issue, all potential causes are being carefully tested.

Because the drug used in the injection was compounded, the contamination could have occurred within a raw ingredient used in the compounding, or it could have become contaminated during the compounding process. The source of the outbreak is not yet known, but because compounded drugs and compounding companies receive less oversight than drug manufacturers, it is suspected that the contaminant was introduced during the compounding process.

Initial symptoms of fungal meningitis are subtle, including headache, fever, dizziness, nausea and slurred speech. The symptoms can take up to a month from introduction of the fungus to appear. If patients have received a shot for back pain, they should contact their doctor to see if it was from the infected lot. Early and immediate treatment is important.

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