All posts by Kim Smiley

Mechanical engineer, consultant and blogger for ThinkReliability, obsessive reader and big believer in lifelong learning
Root Cause Analysis

The Price of Beauty?

By Kim Smiley

In recent years, keratin-based hair products have become increasingly popular.  They smooth hair and many rave over their effective de-frizzing abilities.  These products are expensive, but are consumers paying an even higher price for beautiful hair?

Health concerns about the use of keratin-based hair products have been reported multiple times  over the past several years. The main issue is the formaldehyde contained in many of the products.  Formaldehyde can irritate the eyes and nose, cause skin rashes, and cause asthma-like breathing problems. Formaldehyde is also considered a carcinogen by many organizations.

These hair products contain formaldehyde because it makes the product more effective and longer lasting, but there may be a high health cost, especially to the stylists who perform the procedure.

This issue can be analyzed by building a visual root cause analysis called a Cause Map.  Click on “Download PDF” above to view a high level Cause Map for this issue.

During the root cause analysis, it became clear that one of the causes that contributed to this issue is that many people are unaware of the potential health risk.  This in turn is caused by mislabeling of the products and a lack of safety instructions on the packaging.  Testing by the Oregon OSHA found that many keratin-based hair products labeled as “formaldehyde free” in fact contained significant levels of formaldehyde.  Another cause to consider is that these hair products are considered cosmetics and cosmetics do not require pre-approval by the FDA prior to sale, resulting in minimal government oversight of the product.

OSHA and the FDA  are both investigating the products to determine their safety, but as of right now it is perfectly legal to sell and use keratin-based products containing formaldehyde in the US.  But if you’re interested in using these products, there are several facts you should know to help keep you as safe as possible.  When reading a package, it’s good to know that formaldehyde can be listed in multiple ways, including methylene glycol, formalin, methylene oxide, paraform, formic aldehyde, methanal, oxomethane, oxymethylene, or CAS Number 50-00-0.   It’s also safer to perform this procedure in a well-ventilated area or outside.  Additionally, wearing a mask will prevent inhaling the formaldehyde and some salons now provide them to consumers and stylists to use while the keratin hair products are applied.  You should also carefully wash your hands after handling any product that contains formaldehyde.

Root Cause Analysis

Skin Death Associated with Contaminated Cocaine

By Kim Smiley

Recently, increasing amounts of information has been released regarding patients suffering from tissue death (purpura) associated with use of cocaine “cut” (contaminated) with levamisole.  Levamisole is a veterinary anti-worming drug no longer used in humans because of adverse side effects (such as the tissue death described above and also its interference with the blood marrow’s ability to produce white blood cells, known as agranulocytosis).  The US Drug Enforcement Agency (DEA) reported in 2009 that 69% of cocaine was contaminated, a significant increase from previous years.

This issue can be examined within a root cause analysis captured in visual form.  To begin, we capture the impacts to the goals.  The patient safety goal is impacted because of the tissue death.  Additionally, employees and patient services are impacted because many healthcare organizations are unable to diagnose the issue.  We begin with these goals and ask “Why” questions to continue the analysis.

Why is the tissue death occurring? Tissue death is resulting from levamisole toxicity and ineffective treatment.  The levamisole toxicity occurs from the use of cocaine contaminated with levamisole.  It’s possible that the levamisole is added to the cocaine to increase the effect of the drug.  Additionally, levamisole is cheap, so it increases the volume of the cocaine, which increases profits.  Because cocaine is an illegal drug, it’s not regulated by any government agency.  This means no quality control is in place that would detect the contamination before use.

Ineffective treatment is generally occurring because of the previously discussed inability to diagnose the issue.  Before these reports were made widely available, most practitioners would not think to look at a no-longer-used drug as a cause of toxicity, especially when a patient is not honest about cocaine usage.  As a possible solution to improve treatment of this issue, the reports are suggesting that practitioners look to cocaine abuse when faced with tissue death, which should increase the effectiveness of the treatment for both the tissue death, and other associated issues with contaminated cocaine.  Also, increased public awareness is being attempted to try and reduce the use of cocaine.  Although previous public awareness drug use programs have been less successful than desired, perhaps the risk of skin death will get some users to quit.

For more information, click here.

Root Cause Analysis

Number of Gout Cases Continues to Increase

By Kim Smiley

Gout was historically known as “the disease of kings” or “rich man’s disease” and has long been associated with rich food and excessive alcohol, but recently gout has become a common problem across all socio-economic classes.  More than six million adults in the US have gout and the number will likely keep rising in the future.

Gout occurs when there are high levels of uric acid in the blood stream.  Excessive uric acid forms crystals that collect in joints and soft tissues, causing acute pain and inflammation.  Uric acid is produced when the body processes purines.  Purines are found naturally within the body and are also found in many types of food, including meat (especially organ meat), anchovies, herring, asparagus and mushrooms.

Why are more people suffering from gout? This issue can be investigated by creating a Cause Map and performing a root cause analysis to determine what causes contribute to the problem. (Click on the “Download PDF” button above to view a high level Cause Map of this issue.)

Digging through some of the data available, it becomes clear that the modern diet is one cause, but there are a number of other causes that contribute to gout including higher life expectancy, higher weights, and modern medications.  Risk of gout is also higher for people who suffer from a number of illnesses, including hypertension, diabetes, high cholesterol and congestive heart failure; all diseases which are more common now than they were in the past thanks to advances in modern medicine and increased life expectancy.  Obesity also makes gout more likely and today’s population is heavier on average.  There are also several medications that have been shown to increase the risk of gout, including medicines commonly used to treat high blood pressure and low-dose aspirin.

Gout has typically been considered a man’s disease, but now more women are suffering from it. Prior to menopause, woman naturally have lower levels of uric acid in their blood, but as women live longer more cases of gout are developing in women.

Looking at the risk factors associated with gout, it’s clear why more and more people are suffering from it.  Some risk factors can’t be changed, such as gender or age, but staying healthy overall can reduce the likelihood of suffering from gout.

Never Event

Surgery Performed on Wrong Eye

By Kim Smiley

There are few medical errors scarier than a wrong site surgery.  The idea that you could go to sleep and wake up having had a procedure performed on the wrong body part is terrifying.  Unfortunately, this is exactly what happened to a family in Washington recently.

On April 13, 2011, a surgeon performing a routine procedure to correct a wandering eye mistakenly operated on the wrong eye of a four year old boy.  In this case, the wandering eye was caused by a muscle that was too strong so the surgery was performed to weaken the muscle.  It’s unclear at this point whether the wrong site surgery will have any lasting impact on the patient’s vision, but the patient’s mother has stated that the previously healthy eye is now wandering.  A specialist who examined the boy post-surgery stated that the eye needs to completely heal (about 5 weeks) until any determination can be made about long term consequences.

How did this happen?  How does a surgeon perform a procedure on the wrong part of the body? And most importantly, how do we prevent these types of errors in the future?

The investigation of this incident is still ongoing, but a Cause Map of the incident can be started and then expanded as more information becomes available.  A Cause Map is a visual root cause analysis that lays out the causes of an incident in an intuitive format.  Once the Cause Map is complete, it can be used to develop solutions to help prevent future problems. Click on “Download PDF” above to see an Outline of this incident and the initial Cause Map.

In this example, it isn’t clear yet how the mistake was made.  Findings from the investigation so far have determined that the correct eye was marked before surgery, but statements by the surgeon indicate that the mark may have been accidentally covered by a nurse. The hospital has protocols in place that require checking and double checking the surgery site, but it’s not clear why they weren’t followed.  Once the investigation is complete, the hospital will determine what solutions need to be implemented to ensure that this doesn’t happen again.

Root Cause Analysis

Increased Cost of Drug May Increase Potential for Pre-Term Labor

By Kim Smiley

In 2003, a study by the National Institutes of Health determined that administering hydroxyprogesterone caproate (also known as17P) could reduce the risk of preterm delivery.  Preterm delivery can cause many health issues for infants.  However, there was no commercial source of 17P, so pharmacies compounded it upon request for $10-$20 an injection.  Injections are generally taken starting at weeks 16-24 of pregnancy for up to 20 weeks.

Concern about availability and quality of this compounded drug helped lead to development and expedited U.S. Food and Drug Administration (FDA) approval of a name brand version.  The name brand version was approved on February 3, 2011 and was granted 7 years of market exclusivity under the “Orphan Drug Act”, an FDA incentive to develop products.  The name brand version of the drug was priced at $1,500 an injection.  Concern over the price increase, which could total nearly $30,000 a pregnancy, led to concerns of increases in preterm labor due to the unaffordable drug.  This on turn led to concerns about patient safety and patient services.  Additionally, there has been general outrage over the increase in cost, leading to a request for a Federal Trade Commission (FTC) investigation into the pricing of the drug and a loss of market share for the manufacturer.

To attempt to alleviate the concerns regarding access to the drug, the manufacturer has lowered the price to $690 an injection and has developed a host of other programs to increase affordability of the drug.  The price drop and other programs were announced on April 1, 2011.  The FDA announced on March 30, 2011, that it will not stop pharmacies from continuing to compound 17P, in a rare move to ensure drug availability.  However, some doctors are concerned that prescribing a pharmacy-compounded drug. when there is a brand name drug available, will leave them open to legal action if safety concerns arise.

The impact of this issue on the future of preterm labor and drug pricing is unclear at this point.  It appears that more action may be required to reduce the risk of preterm labor, either by the manufacturer or the FDA, or both.  View the analysis of this issue, including a timeline, problem outline, Cause Map and solutions, by clicking “Download PDF” above

Root Cause Analysis

Contaminated IV Bags Sicken 19

By Kim Smiley

With the aid of the State Health Department and the Centers for Disease Control and Prevention (CDC), six hospitals have traced back recent patient infections to contamination in total parenteral nutrition (TNP) delivered via intravenous (IV) bags.

Although the first infection occurred in January, 2011, a pattern was not established until March, 2011, after nineteen patients were infected with serratia marcescens bacteria.  Patient infection is an impact to the patient safety goal.

The infections occurred as a result of the patients being given contaminated product – in this case, the IV bags.  The bags were recalled, and are no longer in production.  Ten of the patients died.  Investigators have said they won’t be able to determine whether the infection caused the deaths because the patients were already very ill (TNP is used for patients who are too ill to eat on their own).

The IV bags were compounded at a local pharmacy.  There was a potential for contamination in the raw material used for compounding, during the compounding at the pharmacy, or at the hospital.  Because six different hospitals experienced the same rare bacterial contamination, it is unlikely that the contamination occurred at the hospital.

According to Dr. Alexander J. Kallen, a medical officer with the Centers for Disease Control and Prevention, “Historically, what we’ve seen is a breakdown in the manufacturing process.”  The investigation is underway to determine if the contamination was caused by an issue with the manufacturing process, an issue with the sterility of equipment, or a contamination of the raw material.  As the investigation continues, more detail can be added to the Cause Map.  As with any investigation the level of detail in the analysis is based on the impact of the incident on the organization’s overall goals.

While investigating an issue, it can also be helpful to look at the process for identifying and isolating issues, and implementing improvements.  In this case, after patients receive or use products, they are monitored for certain reactions.  If those reactions occur (such as those that indicate a bacterial infection), they are reported to the State Health Department, then the CDC.  The CDC investigates to determine the source of the infection and then pulls the affected products off the market.  Currently, the CDC has identified the product that is contaminated, though not the source of the contamination.

A thorough root cause analysis built as a Cause Map can capture all of the causes in a simple, intuitive format that fits on one page.  To view the Cause and Process maps, click “Download PDF” above.

Root Cause Analysis

Why Potassium Iodide?

By Kim Smiley

In addition to evacuating the people near the nuclear plants in crisis, the Japanese government has distributed potassium iodide.  There has also been a run on potassium iodide on the West Coast of the United States.

Why?

Why would pills protect against radiation?  The first part of the answer lies in the thyroid gland.  The thyroid contains some of the only cells in the body that can absorb iodine.  The thyroid needs iodine in order to produce thyroid hormones which are used by nearly every cell in the body and help regulate important functions such as metabolism.  The second part of the answer is that iodine-131 is a common isotope produced by the fission of uranium atoms during the operation of nuclear reactors.  When fission products are released into the environment and consumed by humans, the thyroid can absorb radioactive iodine, just like it absorbs stable iodine.  Exposure from radioactive iodine can lead to thyroid cancer.

When exposure to radiation is possible, potassium iodide is used because the thyroid has a limit to how much iodine it needs.  If the thyroid has been flooded by stable iodine, it decreases the chance that radioactive iodine will be absorbed.  Any unneeded iodine should be passed through the body relatively quickly, limiting the amount of exposure to the radiation emitted by the iodine-131.

History has shown us that the threat of thyroid cancer is very real following a nuclear reactor accident.  There has been an epidemic of thyroid cancer in the area affected by the Chernobyl accident in 1986.  Experts believe that distribution of iodide potassium could have largely prevented this long term health consequence.  Additionally, the majority of iodine exposure came from drinking milk produced by cows living in the area contaminated by the accident.  If people had avoided drinking contaminated milk in the months following the accident, the effects of radioactive iodine would have greatly been diminished.  Another possible solution that could be applied to help prevent thyroid cancer following a reactor accident would be to test all food and drink for contamination.

There are a few other important facts to consider about potassium iodide.  It is not recommend for low levels of radiation.  The U.S. Nuclear Regulatory Committee has stated that very low levels of radiation may reach the United Stations, but that the amount is well below any harmful limit.  Officials have repeatedly stated that there while use of the potassium iodide is an appropriate precaution for individuals near the accident site in Japan, there is no need for people within the US to take potassium iodide to protect against the effects of radiation.  There are also a number of unpleasant side effects associated with potassium iodide and it is recommended that you speak to your doctor before taking the supplement.

Click on the “Download PDF” button above to view a Process Map of how the body absorbs iodine and a high level Cause Map of the thyroid epidemic following Chernobyl.

Root Cause Analysis

Toddler Dies From Contaminated Wipes

By Kim Smiley

A 2 year old boy died December 1, 2010 following a routine surgery to remove a benign cyst from near his spinal cord and brain.  He appeared to be recovering well when he contracted bacterial meningitis and quickly succumbed to the infection.  Tests revealed the bacteria were a rare strain, Bacillus cerus, which is typically associated with food poisoning and not hospital infections.  How the patient was exposed to the bacteria was initially unknown, but now a potential source has been identified.

On January 5, 2011, The Triad Group, one of the nation’s largest medical product suppliers, announced a massive recall of alcohol wipes, swabs and pads because of contamination from the same rare bacteria, Bacillus cerus.  Products by this manufacturer were used to care for the boy during his hospital stay.  Although, a definitive link between the death of the boy and the recalled pads has yet to be established, there is a lawsuit pending.

Since the time of the recall, other people have come forward with possible cases of infection from Bacillus cerus from using the recalled products.  The FDA has launched an investigation.

Even through the investigation is not completed, this example can be built into a Cause Map based on the information that is available.  A Cause Map is an intuitive, visual method of performing a Root Cause Analysis. Any additional information can be added to the Cause Map as it becomes available and any necessary changes made.

When beginning a Cause Map, the first step is to determine the impact to the organizational goals and document them in an Outline.  In this case, the Safety Goal was impacted because a boy died and there is potential that more people were infected by the same harmful bacteria.  Once the impact to the goals is completed, Causes are added to the map by asking “why” questions. In this case, the boy died from bacterial meningitis because he was exposed to Bacillus cerus.  Next, we would ask “why” he was exposed to the bacteria.

Because the link between the recalled wipes and the death of the patient has not been officially determined, a question mark is included with that information when it’s added.  It’s important that all evidence or lack of evidence is documented on the Cause Map so that it is clear which Causes are agreed upon, known facts and which still need to be proven. Click on the “Download PDF” button above to see a high level Cause Map of this example.

The recall is a short term solution to this problem, but at least all products known to be contaminated should be removed from shelves and hospital storerooms.  It isn’t clear yet what steps are needed at the manufacturer to ensure safety of consumers, but the affected products will not be sold again until they are tested and deemed safe.

Root Cause Analysis

A Controversial Approach to the Fight Against AIDS

By Kim Smiley

Not too long ago, the Downtown Eastside neighborhood in Vancouver, British Columbia had the fastest-growing AIDS epidemic in North America.  But that has is no longer true.  Vancouver has succeeded where many cities have failed and has recently seen a decrease in the rate of new AIDS infections.

How did Vancouver do it?  And can it be done elsewhere?

In order to understand how Vancouver has been successful in fighting the AIDS epidemic, we first need to understand why there were such high infection rates to begin with.  This problem can be approached by building a Cause Map, an intuitive visual root cause analysis method that lays out the Causes to a problem.  (Click on the “Download PDF button” to see a high level Cause Map of this example.)

A little research shows that one of the major contributors to this problem is that a significant percentage of the population in this area is engaged in high risk behavior.  The Downtown Eastside area has been called the center of the injection drug epidemic.  Along with rampant drug problems, this area is also home to a thriving sex trade.  Shared needles and unprotected sex significantly contributed to the fast growing rate of new infections in the area.

As many cities have found out, it is difficult to change behavior.  Drug addicts are typically one of the hardest to reach populations.

Vancouver’s approach has been to create a “safe injection site”, called Insite.  At Insite, addicts can inject drugs they bought on the street under the supervisor of nurses.  They are provided clean needles and a safe location.  To make this work, Insite currently has a special exemption from narcotics laws.

Insite also tests for HIV and provides aggressive treatment for those infected.  Aggressive treatment seems to be one of the main factors that has slowed the infection rate in Vancouver.  Antiretroviral medications lower the amount of virus in the blood, which in turn makes a person 90 percent less infective.

Research has shown that the rate at which the AIDS virus is transmitted can be lowered by treating infected people even if they still engage in high risk behavior.

Unfortunately, treatment can be expensive.  One of the reasons that aggressive treatment works in Canada is that the government provides free healthcare.  In the US, the fastest growing epidemics are typically in low income areas where health insurance is limited.

The antiretroviral medication can also have some unpleasant side effects so many doctors don’t prescribe it until there are signs that their patient’s immune system is compromised.

Vancouver’s approach is also obviously controversial.  Using government funds to provide a place for individuals to inject illegal drugs is going to raise a lot of questions.  Insite was created under a more liberal government and the issue is due to be reviewed by the Canadian supreme court this year.

Root Cause

Using Root Cause Analysis to Achieve Organizational Goals

By Kim Smiley

The Commonwealth Fund’s healthcare improvement website (www.whynotthebest.org) provides case studies of medical facilities that have been improving various performance measures.   One of these cases involves Holland Hospital, in Michigan, which has improved its pneumonia process-of-care over the last five years and is now in the top three percent of hospitals in the U.S. for these core measures.

The process for establishing goals and implementing process improvements to meet those goals is the same process that is used for Cause Mapping.  I’d like to highlight some of the tips from Holland Hospital’s success.  (You can read the whole case study at http://www.whynotthebest.org/contents/view/61.)

Establish a team to develop and work towards goals:  The hospital’s “core measures leadership team” contains physicians, clinical directors and other leaders to ensure buy-in from those closest to the work and management.  The team meets to review noncompliant cases (called “opportunities for improvement”) on a monthly basis.  Additionally, the hospital created a respiratory disease core measure team which developed improvement strategies specific to the pneumonia core measures.

Focus on the system, not on blame: According to the hospital’s director of quality and risk: “the hospital’s patient safety culture means being blame-free. Unless the case is egregious, we assume mistakes occurred because the established care process failed our staff and/or physicians.”  Rather than focusing energy on assigning blame, the team focuses on improving systems to reduce the occurrence of similar incidents, improving the core measures performance for all staff members, not just the ones involved in the noncompliant cases.  As an example, the hospital increased screening for the pneumonia vaccine by reprogramming the electronic nursing record to require an answer to

Get everyone involved: If performance goals are met, and money is available, a bonus pool is established for all full-time employees (even those not directly involved in patient care), except hospital executives.  If the performance goals are not met, no bonus money is distributed.

Adjust responsibilities when necessary: The hospital discovered some difficulties with one measure – taking a blood culture prior to giving antibiotics.  The team discovered that there was a delay in taking the blood culture because a phlebotomist had to be called into the emergency room.  The team also discovered delays in administering antibiotics when a patient was transferred to another unit from the emergency department. A process change resolved these difficulties.  Emergency room nurses now take the blood culture (contacting a phlebotomist assigned to the emergency department if necessary) and administer the first dose of antibiotics before the patient leaves the emergency department.