Hospital Acquired Condition, Root Cause Analysis

Tackling a Seemingly Insurmountable Problem

By ThinkReliability Staff

The goal of any root cause analysis is to uncover causes and, most importantly, solutions that will reduce the risk or mitigate the effects of the problem being studied. However, sometimes a problem seems insurmountable. Take rising health care costs. There are myriad causes that contribute to increasing health care costs. Many of the solutions that have been identified are costly, difficult, or both. Additionally, some solutions place the onus on patients, which can limit the effectiveness. Although patients presumably would love to reduce their health care costs, most don’t have the resources to do so.

Although rising healthcare costs is a national issue, some of the problems you face at an organization may seem just as insurmountable. What can be done when an issue appears too big to fix?

First, ensure that you limit your analysis and potential solutions to your own sphere of influence. Although patients individually reducing obesity and taking their medications properly and on time would certainly reduce healthcare risks, those steps must be taken by the individuals. As a healthcare organization though, it is possible to take steps to increase the probability that individuals will take these steps. Generally patient education, automated reminders, and making it easier to do the right thing – by including clearer instructions on prescriptions or offering more fresh fruit in the hospital cafeteria – are steps that can be taken that are within the realm of an organization’s sphere of influence. Attempting to control solutions outside your sphere of influence is an exercise in frustration!

Next, focus on a single piece of the pie. Not all the causes identified during a root cause analysis have to be tackled at once. A great way to get started: find a solution that is nearly free and can be implemented fairly transparently to staff. For example, ask providers to hand out a healthy eating brochure to patients as they leave their appointment. Is this going to make a big impact? Probably not, but it’s somewhere to start. And even a little impact can help.

Or, take a note from Camden, New Jersey. In Camden, 1% of patients are responsible for 30% of medical costs. Jeffrey Brenner, a local physician, is making a difference reducing costs by focusing on those few patients. This is the big “bang for your buck” solution. And, the solutions that work for this 1% will probably help reduce costs for the other 99% as well. By focusing on a small number of patients – determining the causes specific to them and tailor-making solutions – headway is being made against an extremely difficult problem. (Read more at: http://www.newyorker.com/online/blogs/newsdesk/2011/01/atul-gawande-super-utilizers.html)

If you’re feeling overwhelmed, try taking one step at a time. If healthcare costs can be tackled by looking at a small part of the problem, what can your organization do with a focused look at solutions?

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

Tungsten Particles Remain in Patient’s Bodies After Clinical Trial

By ThinkReliability Staff

Thirty women who participated in a research clinical trial that hoped to revolutionize the treatment of breast cancer are now facing the possibility of long-term effects from tungsten particles left in their body or disfiguring surgery.  The trial involved radiation treatment that could be performed in one short session instead of over many weeks, offering obvious benefits to the patients.  However during follow-up checks after the trial, many women found particles of tungsten, a heavy metal, in their breasts and chest muscles.

Some physicians have recommended removal of the affected areas.  The choice between that, or living with the risk of tungsten particles, whose long-term effect has not been thoroughly studied, is an impact to the patient safety goal.  In addition the particles will look like calcium deposits, which can be an indication of cancer, in future mammograms, resulting in an impact to the patient services goal.  The device has since been recalled, which is an impact to the property goal, and at least one suit has been filed against the manufacturer of the device and the hospital performing the trial.  It is believed that 30 women are affected.

The health issue of leaving the tungsten within the patient’s body is caused by a particle of unknown long-term safety being deposited in the body.  The tungsten appears to have been shed by a device used during radiation treatment to prevent radiation from reaching other parts of the body.  It’s still unknown how a device that would shed particles into a patient’s body made it into a human clinical trial.  What is known is that the device went through the accelerated FDA approval process known as 510(k) for devices that are similar to devices that have already been approved.  It’s unclear which device was considered similar enough to allow for the approval of this one, but there have been many concerns that the FDA’s approval process is insufficient.

An in-depth look at the approval process of the FDA is currently underway to determine where changes in the process may result in a more thorough review and , most importantly, prevent an issue like this one from reoccurring.

Root Cause Analysis

Aging Surgeons

By ThinkReliability Staff

Over 20% of today’s physicians are over the age of 65.  Should this be cause for concern?  After all, we rely on our doctors to take care of us when we are often at our most vulnerable.  While increased age means increased experience, there are also down sides.  Age can bring with it a decrease in physical and mental capabilities, as well as a reluctance to adopt newer technologies.  At least this is what multiple studies have hinted at over the past few years.

The problem is that such a “decrease in capabilities” is highly subjective and difficult to measure.  Surgeons rely on a variety of cognitive and tactile skills in their craft – steady hands, learning new techniques, composure under stress, communication skills, and so on.  As highly trained professionals, it is sometimes difficult to decide when it is time to call it quits.

Furthermore, in the United States, age-based discrimination is outlawed in most industries except where regulated.  For instance, airline pilots and air traffic controllers are both subject to earlier-than-average retirements due to public safety concerns.  Many federal and state public workers, such as corrections officers and firefighters, are similarly limited. It’s difficult to argue that some physicians don’t make similar split-second, life-and-death decisions – especially surgeons.

The associated Cause Map visually lays out the dilemma.  Surgeons who aren’t performing adequately do so for two reasons.  First, they have a medical condition precluding them from performing to standards.  (Note that to keep this Cause Map simple, other issues such as mental health problems, addiction, and failure to maintain their continuing education were not examined.)  Second, they are allowed to continue practicing.

Such physicians continue after their abilities are impacted for a number of reasons.  Some might be unaware of their condition or unwilling to accept it, both stemming from a belief that they are still competent to practice.  Additionally, current processes at most hospital are slow to identify such physicians.  Most hospitals rely on co-workers to identify such doctors, clearly a highly subjective and ethically complex system.  Age-based screening is not common at many hospitals, partly because of resistance from hospital staff.  In fact, only 5-10% of hospitals have directly addressed this issue.  Labeling doctors as “unfit to practice” isn’t necessarily a bad thing.  If such doctors are identified early, patient safety is enhanced.  Additionally, early identification can sometimes allow those doctors to continue practicing in a controlled and safe environment.

Now that the problem has been laid out, the next step is to look for possible solutions.  It’s clear that little can be done about age-related deterioration.  So the focus moves to the other branch of the Cause Map.  Here there are a number of possibilities.  While age-based screening is certainly an option, it’s not the only one.  For instance, including hospital staff in making decisions might also help decrease resistance to identifying deficient physicians.  Additional training on the impacts of age might make co-workers more willing to discuss their concerns.  Or doctors might be more willing to adapt to their limitations if regular screening can identify possible health problems.

While more research is needed to determine how extensive this issue is, it is clear that at most hospitals current procedures to identify deficient physicians are lacking.

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

Kidney Transplant Mix-up

By ThinkReliability Staff

On January 29, 2011, a kidney was transplanted into the wrong patient.  No one was injured, but this was known as a “near miss” – had things gone slightly differently, it could have resulted in severe consequences.  Namely, the patient who received the incorrect kidney could have been killed or seriously injured, had the kidney not happened to be compatible with that patient also.  (The kidney donor had Type O blood, known as the universal donor, which aided in the compatibility.)  The patient who was supposed to receive the kidney could have had a long wait back  on the transplant list.  Luckily, a new donor was found for the second kidney and a new kidney was found for the second donor fairly quickly.  Although there were no injuries, the high potential for injury results in an impact to the patient safety goal.

To try and help figure out what went wrong, we begin with the impacted goal and ask “Why” questions to fill out the analysis. We discover that there were two kidneys that arrived at the hospital simultaneously.  In order for the kidneys to be switched, the kidneys must have been mislabeled, or miss-identified once at the hospital.  The coordinating agency for transplants states that the packaging and labeling of the organs was correct.  We then turn our focus to the identification steps of the organ once at the transplant center.

To aid in determining where process improvements can be made, first we need to define the process.  We can do this with a process map – a step by step instruction of how a process is performed.  In this case, the steps for transplants have been developed by an outside agency – the United Network for Organ Sharing (UNOS).  We can outline these steps in our Process Map.  Because of the high risk for consequence should an error occur, the process is well-defined and consists of checks to ensure that mismatches do not occur.  The last highly publicized incident of a transplant error was in 2003 (see more about that incident here).

The hospital involved has not released details about what might have occurred in the process; however, it’s certain that they’re looking at the process with a fine-tooth comb and trying to implement improvements.  The transplant program has closed down while they’re doing so.

Root Cause Analysis

Pregnant Woman Receives Wrong Medication

By ThinkReliability Staff

One of the most exciting moments in a young couples’ relationship is finding out that they are about to start a family.  New moms-to-be will take extra precautions to make sure their child has the best possible start in life – a healthier diet, a regimen on prenatal vitamins, limitations on coffee and so on.  However, that excitement is sometimes tempered with worry about the new baby’s health.

Mareena Silva had just found out she was expecting.  Six weeks pregnant and a bit under the weather, her doctor prescribed Mareena antibiotics to clear up an infection.  She filled the prescription at the local Safeway, and after taking the medicine as directed, became nauseous.  Upon checking the medication label, she made the horrifying discovery that she had been given the wrong medicine.

Instead of the antibiotics she had been prescribed, Mareena had taken a dose of methotrexate.  Methotrexate is a chemotherapy drug which targets rapidly dividing cells, like cancer…or embryos.  Her doctor urged her to vomit whatever medicine she could.  Then an ambulance rushed her to the hospital where she was given charcoal to absorb any medication remaining in her stomach.  Unfortunately, at this point all she can do is wait to see if her unborn child was affected by the unintended medication.  Methotrexate can cause serious birth defects, especially during the critical formative period during the first trimester, and even miscarriage.  Reports state that the baby faces 50-50 odds of developing abnormalities.

How did Mareena end up with a drug sometimes used to abort ectopic pregnancies?  The pharmacy staff dispensing the medication accidentally handed her one intended for patient in her late 50’s with a very similar name.  According to statements released by Safeway, pharmacy staff failed to repeat Silva’s name to her twice and verify her birth date – standard company policy.  The company has said that they are conducting an investigation to see why their procedure was not followed.  They will not be the only ones looking into the incident; the Colorado Pharmacy Board will also be reviewing the case.

Unfortunately mistakes like this are far too common.  No national agency tracks how many prescriptions are incorrectly distributed, and few states track such information either.  However, a 2003 study by Auburn University indicates that the dispensing error rate could conservatively be estimated at 1%.  That’s astonishing considering billions of prescriptions are filled each year.  How might those errors be prevented?  Dispensing medication is more complex than meets the eye, and there are a number of places a mistake can happen.  In this instance, Safeway’s pharmaceutical staff did not follow proper procedures for dispensing medication.  18.3% of dispensing errors were caused by procedures not followed according to U.S. Pharmacopeia’s 2003 study of medication error reports.

While the investigation will unearth further information about what happened behind the counter that day, a detailed Cause Map pictorially lays out how the incident occurred and why.  As the investigation unfolds, more information can be added and solutions can be developed to prevent future incidents like this one from happening.

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

Patient Death from Complications of Liposuction

By ThinkReliability Staff

On July 18, 2008, a young mother of two went in for a routine tummy tuck (abdominoplasty).  Although liposuction was frequently performed along with the surgery, the patient had declined the liposuction option.  Although there were some complications related to low oxygen during the procedure, the patient was released to her husband that evening.  She was sick the remainder of the evening but assumed it was reaction from the anesthesia.  The next morning she woke with a severe headache that worsened until she asked her husband to call an ambulance.  The paramedic consulted with the attending physician and gave the patient morphine for her pain. The patient then went into convulsions and stopped breathing.  The patient was put into a chemically reduced coma to relieve swelling on her brain.  She never recovered and was taken off life support on July 31, 2008.

The medical examiner determined that it was likely that a fat embolism, a rare complication of liposuction, had prevented blood flow to her brain, causing her death. Because the patient had declined liposuction, it’s unclear how she ended up having the procedure.  It appears that the patient may not have known that she had liposuction, and hence, was not aware of the potential complications including fat embolisms, from liposuction.  The nurse who presented the surgical consent form to the patient said she hadn’t brought up liposuction because it was “implied” as part of a tummy tuck.

It is unclear if the outcome would have been different had the patient received treatment more quickly.  The patient was released to her husband the day of the surgery, as it was considered an outpatient procedure, even though there were complications related to low oxygen.  She was not taken to the emergency room until more than 24 hours after the surgery, possibly because of her and her husband’s insufficient understanding of the risks of liposuction.

The public inquiry into improvements to the healthcare system that might reduce the risks of similar incidents occurring (though the risks for fat embolisms causing brain blood flow blockage are very low) ended last week.  When the results of the public inquiry are released, our initial Cause Map can be updated and the potential action items resulting can be added.