Monthly Archives: August 2014

Root Cause

Epidural of Cleaning Fluid Results in Lasting Pain

By ThinkReliability Staff

A woman in labor was given an epidural of the skin antiseptic chlorhexidine after the container was accidentally switched with that of the epidural drug.  According to a neurologist, the lasting permanent damage was small, but the woman was hospitalized for two weeks, reportedly in severe pain.

The incident can be examined in a Cause Map, or visual root cause analysis, which begins by determining the impact to the goals.  In this case, the patient safety goal is impacted because of the risk of lasting damage.  (The risk is considered small because of the amount that was administered.)  This is a “never event”, or event that should never happen in a healthcare facility.  The patient services goal is impacted because of the cleaning fluid being administered instead of a proper epidural.  The labor/ time goal is also impacted by the investigation and hospital care for two weeks while the woman remained for treatment.

The next step is to perform an analysis, beginning with an impacted goal and asking ‘why’ questions.  In this case, the details that have been released show that the epidural was given with a cleaning fluid when the usual drug was confused with the chlorhexidine and administered when the patient requested an epidural.  The bottles of the two drugs were apparently switched, though at what point is unclear.  Obviously the check of the drugs was ineffective as the result was the wrong drug being administered to a patient.

More detail can be added to the Cause Map as it is discovered during an investigation.  The hospital involved is addressing the cause of the cleaning fluid being present in the same area as the medication by removing the cleaning chemical.  Said Anders Rehn, acting director of the hospital, “We consider this extremely serious.  Obviously this shouldn’t happen.  We have removed the containers so they cannot be switched. The chemical is no longer in the birthing clinic.”

Though this will strongly reduce the risk of this particular chemical being mistaken for a medication, the medication administration process should still be examined for improvement to reduce the risk of other medication errors.

Other chemical mix-ups have been in the news recently.  A restaurant mixed an odorless cleaning-compound lye used for de-greasing the deep fryer into iced tea after mistaking it for sugar.   The only woman who drank the tea received burns in her esophagus but is making a ‘miraculous’ recovery.  Long-term effects will be determined by ongoing tests and procedures.  It was also determined that an employee was burned by the chemical which had been placed in a sugar container.

Two weeks later, a boy drinking a milkshake complained it didn’t taste right.  The milkshake had been contaminated with cleaning product after a worker picked the cleaning product container out of the sink, thinking it had been washed, and filled it with vanilla syrup.  At least two other customers apparently drank the milkshake and were treated at hospital.  Clearly it’s not only medical facilities that need to ensure that there is a high level of protection between items meant for human internal use.  Lessons learned from this incident can be applied to all types of industries to ensure customer safety.

Root Cause

What You Need to Know About Caffeine Powder

By ThinkReliability Staff

1. It can kill you

A teenager died of a caffeine overdose in LaGrange, Ohio on May 27, 2014 after taking caffeine powder.  Regarding caffeine powder, Loraine County Coroner Dr. Stephen Evans says, “What it does is it leads into cardiac arrhythmias, which is speeding heart and it leads into seizures. Those two things are what took his life.”

2. It only takes a little bit

The caffeine in two large cups of coffee (a pretty typical amount for adults) is found in just 1/16th of a teaspoon of caffeine powder.  That’s because caffeine powder is just about all caffeine.  One teaspoon of the powder has the caffeine of about 25 cups of coffee.  The teenager who died from an overdose had 70 mg/mL caffeine in his blood, or about 23 times that of a typical coffee drinker, said Dr. Evans. According to Jennifer Dooren, a spokesperson for the FDA, “The difference between a safe amount and a lethal dose of caffeine in these powdered products is very small.”

3. It’s not regulated

Caffeine powder is sold as a supplement, so you can get it in bulk online.  Because of this, the dose isn’t controlled.  Because such small amounts can be lethal, this means that caffeine powder isn’t safe for anyone.  In a recent warning, the FDA “advises consumers to avoid powdered pure caffeine.”

4. Its use is increasing

Caffeine powder is increasing in popularity for weight loss and energy supplementation.  Other caffeinated products are as well.  Recently, sales of caffeinated gum and alcoholic beverages have been removed from the market.  However, energy drinks remain and are also leading to issues.  As we reported in an earlier blog, emergency room visits from energy drinks more than doubled from 2007 to 2011.  However, because of the concentration, caffeine powder poses the most immediate health risk.  Dr. Henry Spiller, the director of a poison control center at Nationwide Children’s Hospital in Columbus, Ohio says there have been multiple calls in a week that resulted in hospitalization due to caffeine powder use.  He says, “I can’t believe you can buy this,” Spiller said. “Honestly, I mean, it’s frightening. It makes no sense to me.”

5. The risks are not well-known

Three weeks before the young man’s death, his school held an assembly on heroin and painkiller abuse.  Caffeine powder wasn’t covered.  “I don’t think any of us really knew that this stuff was out there,” said Jay Arbaugh, the Keystone Local Schools superintendent. This isn’t surprising.  Caffeine has long been considered the drug with the least potential of abuse.  Cautions Dr. Bob Hoffman, a medical toxicologist at the New York University, “The thing about caffeine is just because you see it every day, just because it’s naturally occurring … doesn’t mean that it’s safe.”  The school will be adding caffeine powder to its drug and alcohol awareness programs.  The FDA is considering regulatory action against these powders.

The FDA recommends seeking medical care immediately and reporting to the FDA adverse events associated with caffeine powder.  You can view a visual diagram of the cause-and-effect relationships that led to the teenagers death by clicking on “Download PDF” above.  Or, read the FDA warning to learn more.

Root Cause

Toxic Algae Bloom Makes Toledo’s Water Unsafe

By Kim Smiley

On the evening of August 1, 2014, 400,000 people living in the Toledo, Ohio region were told not to use or consume tap water.  The water ban was imposed after higher levels of a toxin,  microcystin, than were deemed safe were detected in the water supply.   The water ban was lifted on the morning of August 4, but the issue may not be over since many of the factors that lead to the problem are still present.

This issue can be analyzed by building a Cause Map, or visual root cause analysis.  A Cause Map intuitively lays out the cause-and-effect relationships that contributed to an issue.   In order to build the Cause Map, “why” questions are asked and the answers are documented on the Cause Map.

So why were people told not to use their tap water?  Microcystin is a toxin that can cause vomiting, cramps, rashes and even significant liver damage, and it was detected in the water supply at levels officials deemed unsafe.  (No illnesses have been reported as a result of the toxin.)  The investigation is still ongoing, but many scientists believe the microcystin came from a recent algae bloom in Lake Erie, where the area draws their water.  Algae blooms in Lake Erie are relatively common, but recent weather patterns meant that this particular bloom occurred near  the water treatment plants’ inlets.

Algae are always present in Lake Erie; they can reproduce rapidly and may form a bloom when conditions are conducive to growth and there is high nutrient availability.  Scientists are still working to understand more about the algae blooms, but many believe that phosphorus in agricultural runoff is the main source feeding them.  Phosphorus is commonly used in fertilizer and rain washes it into the lake where it may be consumed by algae.  There are also other possible sources of phosphates such as cattle feedlots and leaky septic systems that need to be investigated.

While it’s tempting to over simplify this issue, it really is very complicated.  There is research showing that an invasive species, the zebra mussel, may be adding to the problem by selectively consuming the non-toxic algae so that any blooms that form are more likely to be toxic. There is still debate about what exactly is causing the algae blooms to form. There are limited federal regulations in place to limit or monitor agriculture runoff and there isn’t agreement on what, if anything, should be done.  There are not even federal limits on the allowable levels of microcystin in drinking water.  Toledo officials used the limits set by the World Health Organization because there isn’t a federal standard.

There are many open questions and not enough answers.  One of the things that we do know is that this particular algae bloom wasn’t particularly bigger or more intense than what has been normal in recent history.  Its main distinguishing characteristic was the location near the water plant inlets.  Scientists are predicting that blooms will peak in September this year so the impacts on the water supply may not be over for the year.

Root Cause

Ebola Outbreak Claiming Lives of Medical Staff

By ThinkReliability Staff

On July 29, 2014, the ongoing Ebola epidemic in west Africa was hit a hard blow when Dr. Sheik Humarr Khan, a leading doctor who treated Ebola patients and  national hero in Sierra Leone, died from the deadly virus.  The outbreak, which began this spring, has now infected thousands and killed nearly 900 people across Sierra Leone, Liberia, Guinea and Nigeria, including more than 90 healthcare workers who were treating victims.  It’s the most widespread and deadliest yet, due to the relative ease of travel and an apparently new strain of the disease.  (Read our previous blog about the outbreak.)

Because of the deadly and quick-spreading nature of the Ebola virus, many precautions are taken to protect healthcare workers from the disease.  Says Marie-Christine Ferir, the Emergency Coordinator of Médecins Sans Frontières/ Doctors Without Borders, “As well as the personal protective equipment that our staff wears, we have a series of strict procedures and protocols.  Our treatment centers are designed to ensure the safest possible working environment for our staff.”  Adds Dr. Tom Frieden, the Director of The Centers for Disease Control and Prevention (CDC), “We work actively to educate American health-care workers on how to isolate patients and how to protect themselves against infection.”

Yet workers are still getting sick – and dying.  In an interview with Armand Sprecher, the medical advisor to Doctors Without Borders, he noted that, though the suits worn by healthcare workers when dealing with infected patients are impervious to fluid, procedures and protocols still have to be followed.  For example, wearing or taking off the suit improperly can cause fluid transfer to the face, or hands, which then may touch the face.  An accidental needle stick can also result in a transfer of fluids that can lead to infection.

Now people in other countries are concerned Ebola may spread further.   In order to give stricken healthcare workers the best shot possible, they are generally returned to their home countries for treatment, raising concerns that their presence will allow the virus to take root there.  An American doctor and nurse were returned to the United States for treatment on August 2nd and August 4th, respectively.  Officials note that every precaution is being taken to isolate the patients and that Ebola can be spread only by bodily fluids, which requires very close contact.

Though there are no vaccines or currently approved treatment for Ebola, the infected American personnel received experimental treatment while still in Liberia. The treatment attempts to use antibodies produced by animals exposed to Ebola to help the immune system fight off the virus.  Dr. Brantly received a blood transfusion from a boy who survived Ebola under his care (surviving Ebola appears to provide immunity against re-infection).  Both vaccines and treatments are in development, but funding is difficult given the relative rarity of Ebola.

In the ongoing attempt to contain the spread of the virus, Sierra Leone has quarantined neighborhoods, cancelled public meetings and overseas trips, while Liberia has closed schools, most borders, and put state employees on leave.  The CDC has issued a Level 3 Travel Warning to Guinea, Liberia and Sierra Leone.  The World Health Organization has launched a $100 million campaign with the aim of bringing the epidemic under control, partially by providing new doctors.

To view the impacts this disease is having on the public as well as healthcare professionals, the causes of these impacts and what is being done to reduce the risk of these impacts, please click on “Download PDF” above.  Or read our previous blog to learn more about the outbreak.

 

Root Cause

Surgical Tool May Spread Cancer

By ThinkReliability Staff

Women who suffer from painful uterine fibroids may have their uterus removed for relief.  The most common hysterectomy procedure involves a 3-to-7-inch incision through which the entire uterus is removed intact.  Surgeries that can be performed laparoscopically through a smaller incision offer less scarring, fewer complications and shorter recovery time.  In order to remove the uterus through a smaller incision, it first has to be cut up into pieces.  This is performed using a laparoscopic power morcellator.  The device can also be used to remove fibroids only (called myomectomy) in a laparoscopic procedure.

On April 17, 2014, the Food and Drug Administration (FDA) issued a statement saying it “discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.” An advisory panel then provided a variety of recommendations, some going so far as to recommend completely banning the use of the device.

The issues surrounding the use of the morcellator can be examined in a Cause Map.  The Cause Map allows a visual diagram of cause-and-effect relationships that include the impacts associated with a particular issue.  In this case, the use of the power morcellator is found to increase the risk of spreading cancer, a clear impact to the patient safety goal.  Concerns about the delay in determining the safety risk (morcellators have been used since the 1990s) can be considered an impact to the patient services goal.  Sales of morcellators have been stopped, and as discussed above, the use of morcellators is being questioned by the FDA.

Beginning with the impacted goals, we can ask “Why” questions to determine the cause-and-effect relationships.  The risk for spreading cancer results from undetected cancer in tissues that are then cut up inside the body.  Uterine cancer is difficult to detect with available testing and can be difficult to distinguish from fibroids.  Additionally, cases have been found where cancer was missed in testing prior to surgical treatment.  Recent studies have shown that women who seek such surgeries have a higher incidence rate of uterine cancer (1 in 368 post-hysterectomy patients were found to have uterine cancer versus 1 in 10,000 for the general population).

The morcellator cuts up tissue so it can be removed laparoscopically in a minimally invasive hysterectomy or myomectomy for fibroids.  Until recently, there was no data or warning indicating that morcellators weren’t safe to use.  The device did not provide clinical trial data, which is not required for new products considered “substantially similar” to existing products that are already marketed.  The FDA does not believe that the cancer risk would have been discovered even with a higher level of scrutiny.  The FDA depends on a database of medical-device problems reported by doctors.  However, doctors are not required to report issues.  In addition, it’s not clear that many made the link from the spread of cancer after the use of the morcellator.  Or, some healthcare professionals say they didn’t report it because they believed the undetected cancer – not the use of a device – was to blame.

The link over spreading cancer has now clearly been established.  (Data is still being examined to see if the device worsens cancer as well.)  The FDA is working to determine what – if any – restrictions will be placed on morcellator use.  It’s pretty clear to some, especially given that this treatment for fibroids is considered elective and there are alternatives, including a traditional hysterectomy.  Says Dr. Craig Shriver, surgical oncologist at Walter Reed National Military Medical Center, “There is at present no safe way to offer laparoscopic power morcellation as part of any minimally invasive surgery.”

However, others think the tool still has a place for minimally invasive surgery and that patients should be able to determine for themselves if the risk is worth taking.  According to Dr. Jason D. Wright, the lead author of a study regarding morcellators published in the Journal of the American Medical Association study, “I don’t know that necessarily morcellation should be banned. But this data is important to allow people to make decisions.”

In the meantime, some facilities are attempting to enclose the uterus in a protective bag before morcellation to minimize the risk of tissue remaining in the body, but there is no evidence that this reduces the risk of cancer spread.  Until the FDA’s final decision, each patient and healthcare facility will have to do their own risk assessment to determine whether or not the tool should be used.