Tag Archives: contaminated supplies

16 patients infected with hepatitis C; thousands potentially exposed

By Kim Smiley

At least 16 patients were infected with hepatitis C after receiving treatment at two hospitals in Utah. Additionally, officials have stated that an estimated 7,200 patients may have potentially been exposed to hepatitis C.  Investigators are working to determine exactly what happened and to test patients who were potentially exposed.

Hepatitis C is a blood-borne illness and cannot be spread by casual contact, including through saliva or sharing food and water. It is not an illness that should typically be at risk of transmission from healthcare professional to patient. A nurse who tested positive for a rare form of hepatitis C worked at the two hospitals that have each had at least one patient who tested positive for the same rare form of hepatitis C. Officials have not released detailed information on how the hepatitis C outbreak occurred, but there are some suspicious circumstances.

The nurse in question was fired in November 2014 after a hospital found evidence that she had diverted medications, which means she was tampering with syringes or other injectable equipment to steal medication.  The nurse pled guilty to the offense and her license was suspended in December of 2015.

It can be very difficult to identify medication tampering by medical personnel, but one of the most alarming facets of this case is that the nurse had been reprimanded and fined by a previous employee for similar misbehavior.  It seems like it should be possible to identify whether a prospective employee has a history of issues with medication diversion during the hiring process. Investigators have not commented on what type of background checks were done prior to her employment at the second hospital, but it seems like an area where hard questions should be asked.

The immediate risk of this particular nurse exposing more patients has been addressed since she is no longer working at a healthcare facility.  The hospitals are offering free testing to anybody who was potentially exposed and are working on a case-by-case basis to determine how to pay for any necessary treatment of those who were infected.  No longer-term solutions have been identified yet, but the investigation is still underway so it is not clear if any lessons learned will result in changes to overall work processes.

Click on “Download PDF” to view an initial Cause Map of this incident.  A Cause Map visually lays out cause-and-effect relationships and can help identify a wider range of causes that contributed to an issue.  Identifying more than a single root cause can promote a wider range of solutions to be considered and can aid in reducing the risk that a problem may reoccur.

Listeria in Ice Cream Causes 3 Deaths

By ThinkReliability Staff

On April 20, 2015, the Centers for Disease Control and Prevention (CDC) announced a recall of all Blue Bell Creameries products due to possible contamination by Listeria monocytogenes.  While the company has not yet determined the source of the outbreak, they are working with outside agencies to determine potential causes and implementing solutions to reduce the risk of food-borne illness in the future.  Says Paul Kruse, the CEO and president, “We’re committed to doing the 100 percent right thing, and the best way to do that is to take all of our products off the market until we can be confident that they are all safe.  At this point, we cannot say with certainty how Listeria was introduced to our facilities and so we have taken this unprecedented step.  We continue to work with our team of experts to eliminate this problem.”

Performing a root cause analysis can help clarify the goals of an investigation, determine the causes of the problem(s) related to an issue, and provide ideas for action items to reduce the risk of the issue recurring.  We can gather the information known so far about the outbreak in a Cause Map, or visual root cause analysis.

The Cause Mapping process begins by capturing the what, when and where of an incident.  Here, the “what” is the Listeria outbreak.  The “when” in this case is believed to have started in 2010 and continued to the present.  It can be helpful to capture any noted differences about the particular investigation.  For example, most outbreaks don’t last 5 years.  The use of genome sequencing (starting in 2013) allowed investigators to tie Listeria cases from 2010 on to this particular outbreak.  An additional difference is that Listeria can replicate in very cold temperatures.  This is unusual because freezing foods generally reduces the risk of propagating food-borne contamination.  The “where” is across the US – all products have been recalled and all plants have been shutdown, with several having been implicated in spreading Listeria.  Another useful piece of information can be the task being performed.  In this case, the contamination was discovered during random sampling.

The next step is identifying the impacts to the goals.  For this incident, the safety goal was impacted due to the sicknesses and deaths.  The outbreak of Listeria can be considered an impact to both the environmental and customer service goal, while the loss of production (no Blue Bell products are currently available or being produced for consumers) is an impact to the production goal.  The disposal of the estimated 8 million gallons of ice cream covered by the recall impacts the product goal, and the response and investigation impacts the labor goal.

The analysis step begins with an impacted goal.  Asking “why” questions develops the cause-and-effect relationships that led to the impacts.  In this case, the sicknesses and deaths were caused by a Listeria outbreak.  In order to have a food-borne illness outbreak, the food needs to be contaminated AND it needs to be delivered to consumers.  In this case, the contamination was not known because ice cream is not tested for Listeria.  There is no history of Listeria outbreaks in ice cream and testing is difficult on perishable products because of the time required.  Once ice cream products are again manufactured for consumers, Blue Bell has said it will implement a test and hold process (holding product until testing comes back negative).

The Listeria contamination results from the introduction of Listeria into the ice cream.  As discussed before, Listeria can replicate in cold temperatures.  The contamination source is likely surfaces in the production facilities or cross-contamination from other food products.  Because multiple plants are contaminated and cleanliness issues have been a concern in the past, it is likely that the outbreak is due to contamination of surfaces, on which Listeria can remain for a long time if not properly sanitized.

In addition to the test and hold process, Blue Bell is in the process of implementing a number of other changes to reduce the risk of future contamination.  Employees are being trained in microbiology and an expanded cleaning and sanitation program.  Prior to production resuming, equipment is being disassembled, cleaned, and tested for contamination and design changes that would make cleaning easier (reducing the risk of future contamination) are being considered.

While it is sometimes difficult to determine the success of solutions, the test and hold process to be used for future ice cream products should provide almost real-time feedback on the success of the programs and ensure that future problems are quickly identified.

To view a one-page PDF of the analysis and solutions, please click on “Download PDF” above.  To learn more about the ice cream Listeria outbreak, click here.  To read our previous blog about the 2011 fatal Listeria outbreak in cantaloupe, click here.

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.


At Least 31 Patients Contracted Hepatitis C

by Kim Smiley

Testing is still ongoing, but at least 31 people have contracted hepatitis C from contaminated syringes at a New Hampshire cardiac catheterization lab.  A previous blog discussed the outbreak when it was initially announced that four patients who had used the same cardiac catheterization lab had tested positive for the same strain of hepatitis C, but more information has been released and the Cause Map should be updated to incorporate all the relevant details.  One of the strengths of a Cause Map, a visual root cause analysis, is that it can be updated relatively quickly to document important information as it becomes available.  In this example, investigators are continuing to work to understand the issues involved, but two new significant pieces of information should be added to the Cause Map.

The source of the hepatitis C has been determined by investigators.  Investigators found that a medical technician with hepatitis C contaminated syringes that were then used on patients.  The medical technician is a drug addict who used the syringes because they were filled with Fentanyl, an anesthetic far more powerful than morphine.  Hepatitis C is spread through blood to blood contact so syringes contained with hepatitis C are a major health hazard that are capable of spreading the disease. The syringes were not secured so he was able to attain them.  He then used them, refilled them with saline or another liquid and replaced them without any other member of the staff noticing.

Investigators have also learned that the medical technician responsible for the contamination has worked in 18 hospitals in seven other states during the last 10 years.  It’s not known when the medical technician contracted hepatitis C, but investigators believe he had a positive test for hepatitis C in June 2010.  This means that the investigation needs to be expanded and that many more people may need to be tested.

This article contains information about what facilities the medical technician worked at and the timeline for his employment.  To view an updated high level “Cause Map”, click here.

Concerns over Faulty Implants

By Kim Smiley

Thousands of women received faulty breast implants between 2001 and 2010.  These implants contain substandard silicone, not approved for medical use, and are also rupturing at a usually high rate.  It isn’t clear at this time what the long term health risks associated with these implants might be.  The faulty implants were manufactured in France, but eighty percent were exported so the wide spread nature of the problem also complicates the implementation of any possible solutions. (These implants were not sold in the US.)

This issue can be investigated by building a Cause Map, an intuitive, visual root cause analysis.  A Cause Map is built by asking “why” questions to determine what causes contributed to an issue.  In this example, women are facing health risks because they received faulty breast implants.  The implants are considered faulty because they are filled with substandard, non-medical grade silicone and they are rupturing at twice the industrial average.

The implants were filled with industrial grade silicone, instead of medical grade, because industrial grade silicon is far less expensive and the company was trying to cut costs.  Hundreds of thousands of these implants were manufactured before any quality issues were raised so inadequate oversight should also be considered as a potential cause.  It isn’t clear why the implants are rupturing at an unusually high rate at this time, but that information can be added to the Cause Map once it is available.

The long term health consequences of this issue also aren’t clear yet.  The substandard silicone used may have impurities in it that could pose a health risk in addition to any health effects that result from the ruptured implants in general.  There are concerns that the implants are increasing the risk of breast cancer, but there isn’t any hard evidence that this is the case at this point.  All the countries involved are struggling to weigh the known risks of removing the implants with the unknown risks of leaving them in place.  There is also the question of costs and who will pay for removal or replacement of the faulty implants. Ongoing monitoring for signs of leakage and ruptures are recommended for any woman who chooses to keep the implants.

Surgical Tools Cleaned with Hydraulic Fluid

By Kim Smiley

In late 2004, a healthcare system in North Carolina realized that it had been using elevator hydraulic fluid instead of cleaning detergent when cleaning its surgical tools.  Before the problem was realized, the improperly cleaned tools were used on 3,650 patients.  An analysis by infection control, material and toxicology experts determined that the sterilization process of the tools was not affected and that trace metals left on the tools from the hydraulic fluid were in too small of amounts to cause risk to patients.  Nonetheless, the potential for these safety risks is an impact to the patient safety goal.  Additionally, the fact that improperly cleaned tools were used on patients is an impact to the patient services goal.  Lastly, the re-cleaning and sterilization required for the tools is an impact to the labor goal.

This incident can be examined in a Cause Map or visual root cause analysis. The first step is to define the problem with respect to the impacts to the organization’s goals, as described above.  The second step is to begin with the impacted goals and ask “why” questions to diagram the cause-and-effect relationships that led to the incident.  In this case, improperly cleaned tools were used on patients because the tools were cleaned with hydraulic fluid and the tools were used on patients.  The tools were used on patients because it was not immediately obvious that they had been improperly cleaned.  The tools did retain an oily feel; however, the tools are lubricated as part of the cleaning and sterilization process to avoid rust and ensure proper operation and so may retain an oily feel.

The tools were cleaned with hydraulic cleaning fluid because the hydraulic fluid was stored in the cleaning detergent containers and delivered to system hospitals.  The containers were filled with elevator hydraulic fluid by an elevator maintenance company and left where they were picked up by the cleaning detergent provider.  The provider did not realize that the containers had been tampered with (as they were not relabeled and either had no indication of tampering or were not inspected for tampering) and so delivered them to the hospitals for use.

Once the problem was realized, the affected tools were re-cleaned and sterilized and the detergent replaced.  Follow-up monitoring was performed and appointments offered to the affected patients, despite determination that the sterilization process was not affected and that the trace metals were not in sufficient amounts to affect patient safety.  Employees were trained in container management and a process was added to verify the status of containers delivered to and used in the hospital.  Additionally, a process to determine when product integrity has been compromised.  An external review by the Centers for Medicaid and Medicare Services has certified that the impacted hospitals are in compliance with standards based on these implemented corrective actions.

To view the Outline, Cause Map and implemented solutions, please click “Download PDF” above.  Or click here to read information provided by the affected healthcare system.

Bacterial Contamination of Tampons

By ThinkReliability Staff

On November 9, 2011, the FDA announced a recall of a certain subset of tampons for contamination with the bacteria Enterobacter sakazakii.  The recall is for certain products delivered to certain stores, mainly in the central U.S. Region.  For a full list of the product  recalls, check the FDA recall site.

The specific source of the contaminant has not been identified.  Investigations of previous instances of contamination with the Enterobacter sakazakii have had difficulty determining an exact source, as this bacteria is found within human  and animal guts.  However, even with limited information, we can begin a Cause Map, or visual root cause analysis, which allows us to view the areas where more data collection is needed in order to gather evidence to complete the analysis.

We begin by capturing the basic information about the incident as well as the impacts to the goals.  The safety goal is impacted due to the risk of infection from the contamination tampons.  The environmental and customer service goals are impacted because a product was bacterially contaminated.  Additionally, the product recall impacts the production, property and labor goals.  We begin our Cause Map with the impacts to the goals.

Both the risk for infection and the product recall were caused by the bacterial contamination of a product.  The product was contaminated because contaminated raw material was used for its manufacture.  This occurred both because the raw material was contaminated and because the quality control or testing process for the raw material was insufficient.  Whether there was no testing process for the given bacteria or whether the process did not recognize the bacteria and stop the use of the contaminated raw material is unclear.

At this point, because the source of the raw material contamination is unknown, an open question which requires evidence-gathering is “how did the raw material get contaminated”? This will require cooperation from the raw material manufacturer.   The other necessary information is to do a detailed review of the quality control and/or testing that is used on raw materials prior to manufacturing and determine how the contaminated material was able to be used to make a final product.  Once this process is looked at in detail, specific solutions that would prevent a recurrence of this type of contamination can be implemented.

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

A Stealth Contact Lens Recall?

By Kim Smiley

Avaira Toric contact lenses, manufactured by CooperVision Inc, were voluntary recalled on August 19, 2011.  The recall occurred after dozens of consumers complained about eye problems including impaired vision, eye pain and torn corneas.  According to a company statement, a manufacturing error resulted in a silicone oil residue on some contacts.  More than 8 million lenses were affected worldwide by the recall, but only about 780,000 of these contact lenses were distributed in the USA.

The company has received a large amount of negative media attention following the recall.  News articles and blogs  have claimed that CooperVision was purposely downplaying the recall, resulting in many consumers being unaware that their lenses had been recalled. Unaware of the potential danger, consumers continued to wear their lenses and continued to have eye problems as a result. The FDA publicly threatened to independently inform consumers of the risk associated with these contact lenses if the manufacturer didn’t better publicize the recall.

Following the media attention , the company has increased efforts to notify consumers about the recall.  The FDA has also posted a notice on their website of this recall, identifying it as a Class I recall, the most serious class of recall. The FDA has said that the company’s actions are now consistent with what would be expected with a Class I recall.

This example is a good illustration that the execution of a recall is a very important thing.  If consumers view a recall as slow to happen or badly executed, they will probably be less likely to trust a company in the future.  Ideally, a recall should be executed so that consumers are left with the feeling that a company did the right thing as quickly as possible.

If you are concerned that you might have recalled lenses, you can visit this website  to check.  If your lenses are recall, you are asked to remove them immediately and return them to the point of purchase.

Click on “Download PDF” above to view an outline and initial Cause Map of this example.

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.

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.