Tag Archives: cause mapping

Root Cause Analysis

Put down the cookie dough

By ThinkReliability Staff

Almost everybody knows that there are potential risks with eating raw cookie dough (or any other raw batter).  However, much of that risk was thought to be due to the potential of salmonella from raw eggs and so, if the plan was to eat, rather than cook, the dough, the eggs could just be left out.  No more! say health experts.  Turns out that just removing the eggs and eating the raw dough may protect you from salmonella, but it still leaves you at risk for E. coli.

A Cause Map, or visual form of root cause analysis, can help demonstrate the risks (or potential impacts) associated with an issue, as well as the causes that lead to those risks.  The process begins by capturing the what, when and where of an incident, as well as the impact to the goals in an Outline.  In this case, the problems being addressed are risk of illness from eating raw cookie dough, as well as a recall associated with contaminated flour.  The when and where are just about everywhere that dough or batter is being made (or eaten).  The safety risks most commonly associated with eating raw cookie dough are salmonella and now E. coli.  The environmental goal is impacted because flour is contaminated with E. coli and the property goal is impacted because of 45 million pounds of flour that have been recalled by the current recall.

Once the impacted goals are captured, they become the first “effects” in the cause-and-effect relationships.  The Cause Map is created by capturing all the causes that led to an effect.  In this case, the risk of contracting salmonella from eating raw cookie dough results from eggs being exposed to salmonella, and the salmonella not being effectively destroyed (by the heat of baking).  The risk of contracting E. coli results from a similar issue.

Cookie dough contains raw flour.  The cooking process kills E. coli (as well as salmonella), meaning cookies and other baked goods are safe to eat, but dough is not.  Distributed raw (uncooked) flour was found to be contaminated with E. coli (leading to the impacted environmental goal and the recall).  The flour was likely contaminated with E. coli while it was still wheat in the field.  Birds and other animals do their business just about wherever they want, and it’s got some bacteria in it, meaning that excrement that falls on wheat fields can deliver contamination to pre-flour.  (Quick side note: we frequently get asked when to stop asking “why” questions.  When you get to an answer that is completely outside your control, like why birds poop in wheat fields, for example, this is a good place to end the cause-and-effect reasoning.)

While flour is processed, the process isn’t designed to completely kill pathogens (unlike pasteurization, for example) and according to Martin Wiedmann, food safety professor at Cornell University, “There’s no treatment to effectively make sure there’s no bacteria in the flour.”  Flour is not designed to be a ready-to-eat product.

Once the causes related to an issue have been developed, the next step is to brainstorm and select solutions.  Unfortunately, health professionals have been clear that they’re not getting far on keeping birds from pooping in fields, nor is there some sort of miracle treatment that will ensure raw flour is safe from disease.  (Scientists underscore that flour isn’t less safe, it’s just that we are becoming more aware of the risks.  Says Wiedmann, “Our food is getting safer, but also our ability to detect problems is getting better.”)  The only way to reduce your risk of getting sick from raw cookie dough is . . . not to eat it at all.  Also, wash your hands whenever you handle flour. (This is of course after you’ve thrown out the floor involved in the recall, which you can find by clicking here.)

To view the Cause Map of the problems associated with raw cookie dough, please click on “Download PDF” above.

Root Cause Analysis

Patient receives double dose of radiotherapy

By ThinkReliability Staff

The risk associated with medical treatment administration is high. There is a high probability for errors because of the complexity of the process involved in not only choosing a treatment, but ensuring that the amount and rate of treatment is appropriately calculated for the patient. The consequence associated with treatment errors is significant – death can and does result from inappropriately administered treatment.

Medical treatment includes delivery of both medication and radiation. Because of the high risk associated with administering both medication and radiation therapy, independent checks are frequently used to reduce risk.

Independent checks work in the following way: one trained healthcare worker performs the calculation associated with medical treatment delivery. If the treatment is then delivered to the patient, the probability that a patient will receive incorrect treatment is the error rate of that healthcare worker. (For example, a typical error rate for highly trained personnel is 1/1,000. If only one worker is involved with the process, there is a 0.1% chance the patient will receive incorrect treatment.) With an independent check, a second trained worker performs the same calculations, and the results are compared. If the results match, the medication is administered. If they don’t, a secondary process is implemented. The probability of a patient receiving incorrect treatment is then the product of both error rates. (If the second worker also has an error rate of 1/1,000, the probability that both workers will make an error on the same independently performed calculation is 1/1,000 x 1/1,000, or 0.0001%.)

However, in a case last year in Scotland, a patient received a significant radiotherapy overdose despite the use of independent checks, and verification by computer.   In order to better understand how the error occurred, we can visually diagram the cause-and-effect relationships in a Cause Map. The error in this case is an impact to the patient safety goal, as a radiotherapy overdose carries a significant possibility of serious harm. The Cause Map is built by starting at an impacted goal and asking “why” questions. All causes that result in an effect should be included on the Cause Map.

In this case, the radiotherapy overdose occurred because the patient was receiving palliative radiotherapy, the incorrect dose was entered into the treatment plan, and the incorrect dose was not caught by verification methods. Each of these causes is also an effect, and continuing to ask “Why” questions will develop more cause-and-effect relationships. The incorrect dose was entered into the treatment plan because it was calculated incorrectly (but the same) by two different radiographers working independently. Both radiographers made the same error in their manual calculations. This particular radiotherapy program involved two beams (whereas one beam is more common). The dose for each beam then must be divided by two (to ensure the overall dose is as ordered). This division was not performed, leading to a doubled calculated dose. The inquiry into the overdose found that both radiographers used an old procedure which was confusing and not recommended by the manufacturer of the software that controlled the radiotherapy delivery. While a new procedure had been implemented in February 2015, the radiographers had not been trained in the new procedure.

Once the two manual calculations are performed, the treatment plan (including the dose) was entered into the computer (by a third radiographer). If the treatment plan does not match the computer’s calculations, the computer sends an alert and registers an error. The treatment plan cannot be delivered to the patient until this error is cleared. The facility’s process at this point involves bringing in a treatment planner to attempt to match the computer and calculated doses. In this case, the treatment planner was one of the radiographers who had first (incorrectly) performed the dose calculation. The radiographers involved testified that alerts came up frequently, and that any click would remove them from the screen (so sometimes they were missed altogether).

The inquiry found that somehow the computer settings were changed to make the computer agree with the (incorrect) manual calculations, essentially performing an error override. The inquiry found that the radiographers involved in the case believed that the manually calculated dose was correct, likely because they didn’t understand how the computer calculated doses (not having had any training on its use) and held a general belief that the computer didn’t work well for calculating two beams.

As a result of this incident, the inquiry made several recommendations for the treatment plan process to avoid this type of error from recurring. Specifically, the inquiry recommended that the procedure and training for manual calculation be improved, independent verification be performed using a different method, procedures for use of the computer be improved (including required training on its use), and requiring manual calculations to be redone when not in agreement with the computer. All of these solutions will reduce the risk of the error occurring.

There is also a recommended solution that doesn’t reduce the risk of having an error, but increases the probability of it being caught quickly. This is to outfit patients receiving radiotherapy with a dosimeter so their received dose can be compared with the ordered dose. (In this case, the patient received 5 treatments; had a dosimeter been used and checked the error would likely have been noticed after only one.)

To view the Cause Map for this incident, please click on “Download PDF” above.

Root Cause Analysis

Particulate Matter Closes Operating Rooms at VA Hospital

By ThinkReliability Staff

On February 17, 2016, the 5 operating rooms at a New York Veterans Affairs (VA) hospital were closed due to particulates falling from the air ducts. An internal email from the engineer & safety officer to administrators at the hospital described the problem as this: “The dust is depositing on HVAC registers, ceilings, walls, and on medical equipment. Maintenance continues to clean the surfaces but, as the staff has observed, the dust reappears within a short time. At least three staff members have indicated their concern that this environment has affected them. They have been sent to employee health and to their individual physicians.”

The information related to this issue determined as part of the incident investigation can be captured within a Cause Map, a visual form of root cause analysis. The first step of the process is to determine the impacts to the goals. In this case, both patient and employee safety are impacted due to the risk of illness from exposure to the particulates. The environmental goal is impacted because of the release of the particulates into the facility. Patient services are impacted because patients are being sent to other facilities as sterile procedures are not being performed (an impact to the production/ schedule goal). The labor and time required for an investigation is also an impact to the goal.

The second step of the process is the analysis: determining why these goals were impacted. The release of the particulates into the facility is because there are particulates within the air ducts, and the air ducts open into the facility to provide heating, ventilation and air conditioning. In order to determine where the particulates come from, first it must be determined what they are composed of. An environmental analysis determined that the particulates were rust, crumbling concrete, fiberglass fibers, and cladosporium (a common mold).

The analysis also identified that rust in air systems typically results from aged equipment exposed to moisture. Cladosporium also results from exposure to moisture. The air duct system pulls in outside air, including humidity, resulting in the system being exposed to moisture. The VA hospital is 45 years old, which actually makes it one of the “newer” VA facilities. (According to the VA, about 60% of its facilities are more than 60 years old.) While it’s unclear what maintenance or replacements have been performed on these components over the life of the facility, deferred maintenance is a general problem at VA facilities. According to the VA inspector general, there is a $10-12 billion maintenance backlog at the department.

Once the causes of the problems (or impacted goals) have been determined, the last step is to implement action items to reduce the risk of the problem recurring. There are two parts to this step: brainstorming possible solutions, and determining which will be most effective to meet the organization’s needs. The hospital considered bringing in mobile surgical units and installing high efficiency particulate air filters in the vents in the operating rooms. The cost of the mobile surgical units (over $70,000 per month) led the hospital to select only the solution of the air filters. At least one operating room is expected to be ready to return to service June 1st.

To view a one-page downloadable PDF of the incident investigation, including the impacted goals, analysis with evidence, and possible solutions, please click on “Download PDF” above.

Root Cause Analysis

Regulators ask hard questions about blood testing startup Theranos

By Kim Smiley

The biotech startup Theranos has been all over headlines in recent years.  At first the company made news for its ambitious goals of running comprehensive laboratory testing on just a few drops of blood.  The company has claimed to have created a handheld medical device (nicknamed Edison) that uses only a finger prick of blood and makes blood testing less painful, faster and cheaper.  Theranos’ young and compelling founder Elizabeth Holmes has been featured in multiple magazines, gave a popular Ted talk and has even been compared to Steve Jobs and Bill Gates. In 2014, the company was valued at $9 billion.

Lately, the type of headlines the company has made have changed as the company has been embroiled in controversy.  The multiple concerns about Theranos can be visually represented in a Cause Map, a visual format for performing root cause analysis.  A Cause Map intuitively breaks down a problem to the basic cause-and-effect relationships and visually lays them out.  (Click on “Download PDF” to view an intermediate Cause Map of these issues.)  Many of the issues raised haven’t been proven yet and require more evidence so a question mark is used to note this open question within the cause box.

The problems for the company started coming to a head in the latter half of 2015. A December 2015 report by The Wall Street Journal, At Theranos, Many Strategies and Snags, raised concerns about the accuracy of the company’s propriety handheld blood testing device.  Studies showed that the results of the Edison device differed from testing done by traditional blood testing methods. Additionally,  inspections over a three-week period in August and September 2015 at two Theranos facilities found multiple issues.  Specifics on the exact problems found during the inspections have not been released, but they have been described generically as problems with record keeping, quality audits, and handling of consumer complaints. The FDA has also raised concerns about the approval of a medical device called a nanotainer that is used by Theranos. The nanotainer was classified as a Class I exempt device during the approval process and it should have been classified as a risky Class II device that would have received greater scrutiny during the approval process.

A federal criminal investigation into Theranos is now underway looking into claims the company made about its technology.  A separate probe by the Securities and Exchange Commission is working to determine whether the company misrepresented its new blood testing technology and its claim that it could run a full range of laboratory tests from just a prick of blood from a finger.

As of right now, Theranos has taken a beating in the court of public opinion, but the company has not been convicted of anything and is still selling blood tests from 40 Walgreens in Arizona.  Only time will tell the fate of the company, but the issues it has faced can be seen as a cautionary tale for other biotech startups.  Even if the company is cleared of all wrongdoing, there are lessons to be learned about ensuring laboratories meet all appropriate standards and ensuring proper approvals of all medical devices.

Root Cause

Programming Errors Can Impact Patient Safety

By ThinkReliability Staff

Clinical decision support systems (CDSS) aim to improve health care quality, safety and effectiveness by providing alerts to providers based on criteria (such as identifying drug interactions). However, a malfunctioning CDSS can actually reduce patient safety when physicians rely on these alerts.

According to “Analysis of clinical decision support system malfunctions: a case series and survey” by Adam Wright, et al, published March 28, 2016, “CDSS malfunctions are widespread and often persist for long periods. The failure of alerts to fire is particularly difficult to detect. A range of causes, including changes in codes and fields, software upgrades, inadvertent disabling or editing of rules, and malfunctions of external systems commonly contribute to CDSS malfunctions, and current approaches for preventing and detecting such malfunctions are inadequate.”

A survey that was part of the analysis found that 93% of Chief Medical Information Officers who responded had experienced at least one CDSS malfunction and two-thirds experienced at least an annual CDSS malfunction. Four such malfunctions were found within the CDSS system at Brigham and Women’s Hospital and were presented as case studies. We will examine one of these case studies within a Cause Map, or visual form of root cause analysis.

The first step in any root cause analysis method is to identify the problem. The CDSS malfunction in this case study involved a stopped alert for annual thyroid testing in patients prescribed amiodarone. When the issue was noticed and resolved in February 2013, it was determined that the alert had been stopped since November 2009, when the internal code for the drug amiodarone was changed.

An important step in describing the problem is to determine the organizational goals that were impacted. In this case, patient safety is impacted because of the potential for untreated thyroid issues and patient services are impacted because of the potential of missed testing.

The second step is to perform the analysis by developing the cause-and-effect relationships that led to the impacted goals. In this case, patient safety is impacted because of the potential for untreated thyroid issues. Patients may have untreated thyroid issues if they are taking amiodarone to treat arrhythmia. Amiodarone has a known side effect of thyroid issues. If staff is unaware of a patient’s thyroid issues, that patient won’t be treated. Staff would be unaware of thyroid issues in a patient if testing is not performed.

The goal of clinical decision support systems is to identify interventions based on patient needs – in this case, the hospital created an alert to suggest thyroid testing for patients who had been amiodarone and had not had a thyroid test in at least a year. Based on typical alert values from the years prior to 2009, the analysis determined that more than 9,000 alerts suggesting thyroid testing were missed.

Thyroid tests were missed because the CDSS did not identify the need for thyroid testing, and because physicians may rely on the CDSS to recommend a test like this one. The alert was originally set up to identify patients taking amiodarone (then code 40) with a start date at least 365 days ago, and no thyroid test values from within the last 365 days. In November 2009, the internal code for amiodarone changed to 7099, but the logic for the alert was not changed. (The reason for the code change is unclear.) As patient records were updated with the new code for amiodarone, the alert failed to identify them for thyroid testing.

The issue was identified during a demonstration of this particular feature of the CDSS and fixed the next day. While the details aren’t known, this issue identifies an ineffective change management program. When changes are made within systems, change management processes are necessary to ensure there are no unintended consequences. While updating the amiodarone code in the alert logic fixed this particular problem, a robust change management program is necessary to ensure that there are no other unintended consequences that could affect patient safety.

To view a visual root cause analysis of this example, please click on “Download PDF” above.

Root Cause Analysis

Questionable medical advice leads to death of old lady who swallowed a fly

By ThinkReliability Staff

There was an old lady who swallowed a fly. This was presumably accidental, but whatever the reason, it happens. Then the old lady swallowed a spider. Again, it happens. And, if you were looking for a Darwin-ish way to catch live flies, this seems to make sense. However, at that point, whether due to increasing hysteria or bad medical advice (possibly from the internet?), the old lady then proceeded to swallow progressively larger and larger animals until it led to her untimely death.

After swallowing the spider which, according to an eyewitness, wiggled and jiggled and tickled inside her, the old woman apparently felt that ingesting another animal that could catch the spider would be a good idea. So, she swallowed a bird. Now, this isn’t entirely illogical – birds do catch spiders. But the idea of ingesting a bird whole would give most of us pause. Even if it didn’t, there aren’t many types of birds that many people could easily swallow whole. Regardless, this is what the old lady did.

Continuing to move up the food chain, the logical choice of animal to catch a bird is a cat. Of course, many of us have cats as pets, and can’t imagine swallowing them, even for the purposes of catching a bird. But again, this is what the old lady did. Maybe the horror of what she had done finally got to her, because her next actions didn’t seem to answer to logic. Next, the old woman swallowed a dog. Although dogs chase cats, it’s unclear how often they “catch” them. A better choice to “catch” a cat would have probably been a cardboard box.

Then the old lady went for a goat. While goats are good for eating grass (and various other things), there’s no real evidence that goats have any desire to catch dogs. In fact, dogs are occasionally used for herding goats, so it’s unclear why the old lady would have turned to a goat next. But again, that’s what she did.

By then the delirium was apparently at an all-time high, because the old lady then swallowed a cow. It has been verified by veterinary experts that cows are not capable of catching ANYTHING, much less a goat (plus the dog and cat that are likely still running loose in there). After swallowing a cow, the old lady then gave one last ditch effort to finally wrangle all those animals she had swallowed and swallowed a horse. Beyond the obvious physical challenges involved in swallowing a horse (clearly involving an unhinged jaw and a very, very flexible throat), there are, again, moral considerations as well. But a horse does seem a better choice to wrangle a bunch of animals, although horses used for herding are generally controlled by a human rider . . from the outside. Sadly, eating a horse was too much, even for our very sturdy old lady, and that was the last thing she ever swallowed.

While the desire to catch animals already swallowed appears to be the main driving force behind the rather interesting last meal of the old lady, the question “why” is always close at hand. In particular, why did the old lady choose this particular line-up of animals? Because our best witness (the old lady) is speaking no more, we can only guess at what led to her decisions. I suspect that she came upon a nursery rhyme on the internet and confused it for advice. Which is why, any time you have a concern about something that somebody swallowed, it’s best to see or call a doctor, or poison control. (And if you swallow a fly, your stomach acid will make quick work of it, so no worries.)

Because of the risk of death involved, I propose that we place warning signs on all animals not meant to be consumed whole. The obstacles in implementing this solution are many, but when deaths of old ladies are at stake, one cannot be too safe.

To view the investigation of the old lady’s death, please click “Download PDF” above. Happy April Fools’ Day from ThinkReliability!

 

Root Cause

Death from Patient-Controlled Morphine Overdose

By ThinkReliability Staff

Could improving the reliability of the supply chain improve patient safety?

The unexpected death of a patient at a medical facility should always be investigated to determine if there are any lessons learned that could increase safety at that facility. A thorough analysis is important to determine all the lessons that can be learned. For example, the investigation into a case where a patient death was caused by a morphine overdose delivered by a patient-controlled analgesia (PCA) found that increasing the reliability of the supply chain, as well as other improvements, could increase patient safety.

The information related to this patient death was presented as a morbidity and mortality case study by the Agency for Healthcare Research and Quality. The impacts to goals, analysis, and lessons learned from the case study can be captured in a Cause Map, a visual form of root cause analysis that develops the cause-and-effect relationships in sufficient detail to be able to find solutions that will reduce the risk of similar incidents recurring.

Problem-solving methodologies such as Cause Mapping begin with defining the problem. In the Cause Mapping method, the what, when and where of the problem is captured, as well as the impact to the goals, which defines the problem. In this case, the patient safety goal is impacted due to the death of a patient. Because the death of a patient under medical care can cause healthcare providers to be second victims, this is an impact to the employee safety goal. A death associated with a medication error is a “Never Event“, which is an impact to the compliance goal. The morphine overdose is an impact to the patient services goal. In this case, the desired medication concentration (1 mg/mL morphine) was not available, which can be considered an impact to the property goal. Lastly, the response and investigation are an impact to the labor/time goal.

The analysis begins with one impacted goal and developing cause-and-effect relationships. One way to do this is by asking “Why” questions, but it’s also important to ensure that the cause listed is sufficient to have resulted in the effect. If it’s not, another cause is required, and will be joined with an “AND”. In this case, the patient death resulted from a morphine overdose AND a delayed response to the patient overdose. (If the response had come earlier, the patient might have survived.) It’s important to validate causes with evidence where possible. For example, the morphine overdose is a known cause because the autopsy found a toxic concentration of morphine. Each cause in the Cause Map then becomes an effect for which causes are captured until the Cause Map is developed to the point where effective solutions can be found.

The available information suggests that the patient was not monitored by any equipment, and that signs of deep sedation, which preceded respiratory depression, were missed during nurse checks. Related suggestions for promoting the safe use of PCA include the use of monitoring technology, such as capnography and oximetry, and assessing and recording vital signs, including depth of respiration, pain and sedation.

The patient in this case was given PCA morphine. However, too much morphine was administered. The pump settings were based on the concentration of morphine typically used (1 mg/mL).   However, that concentration was not available, so a much higher concentration (5 mg/mL) was used instead. The settings on the pump were entered incorrectly for the concentration of morphine used, likely because of confirmation bias (effectively assuming that things are the way they always are – that the morphine on the shelf will be the one that’s usually there). There was no effective double check of the order, medication and pump settings.

Related suggestions for promoting the safe use of PCA include the use of “smart” pumps, which suspend infusion when physiological parameters are breached, the use of barcoding technology for medication administration (which would have flagged the use of a different concentration), performing an independent double check, storing only one concentration of medications in a dispensing cabinet (requiring other concentrations to be specially ordered from the pharmacy), standardizing and limiting concentrations used for PCA, and yes, improving the supply chain so that it’s more likely that the lower concentration of morphine will be available. Any of these suggestions would improve patient safety; implementation of more than one solution may be required to reach an acceptable level of risk. Imagine just improving the supply chain so that there would be very few (if any) circumstances where the 1 mg/mL concentration of morphine is unavailable. Clearly the risk of using the wrong concentration would be lessened (though not zero), which would reduce the potential for patient harm.

To view a one-page downloadable PDF with the outline, Cause Map, and action items, click “Download PDF” above. Click here to read the case study.

Hospital Acquired Condition

“Desensitization” Process Improves Compatibility of Donor Kidneys

By ThinkReliability Staff

Many patients with advanced and permanent kidney failure are recommended for kidney transplants, where a donor kidney is placed into their body. Because most of us have two kidneys, donor kidneys can come from either living or deceased donors. If a compatible living donor is not found, a patient is placed on the waiting list for a deceased donor organ. Unfortunately, there are about 100,000 people on that waiting list. While waiting for a new kidney, patients must undergo dialysis, which is not only time-consuming but also expensive.

Researchers estimate that about 50,000 people on the kidney transplant waiting list have antibodies that impact their ability to find a compatible donor kidney. Of those, 20,000 are so sensitive that finding a donor kidney is “all but impossible” . . . .until now.

A study published March 9, 2016 in the New England Journal of Medicine provides promising results from a procedure that alters patients’ immune systems so they can accept previously “incompatible” donor kidneys. This procedure is called desensitization. First, antibodies are filtered out of a patient’s blood. Then the patient is given an infusion of other antibodies. The immune system then regenerates its own antibodies which are, for reasons as yet unknown, less likely to attack a donated organ. (If there’s still a concern about the remaining antibodies, the patient is treated with drugs to prevent them from making antibodies that may attack the new kidney.)

The study examined 1,025 patients with incompatible living donors at 22 medical centers and compared them to an equal number of patients on waiting lists or who received a compatible deceased donor kidney. After 8 years, 76.5% of the patients who were desensitized and received an “incompatible” living donor kidney were alive compared to only 43.9% of those who remained on the waiting list and did not receive a transplant.

The cost for desensitization is about $30,000 and a transplant costs about $100,000. However, this avoids the yearly life-long cost of $70,000 for dialysis. The procedure also takes about two weeks, so patients must have a living donor. The key is that ANY living donor will work, because the desensitization makes just about any kidney suitable, even for those patients who previously would have had significant trouble finding a compatible organ. Says Dr. Krista L. Lentin, “Desensitization may be the only realistic option for receiving a transplant.”

The study discusses only kidney transplants but there’s hope that the process will work for living-donor transplants of livers and lungs. Although the study has shown great success, the shortage of organ donations – of all kinds – is still a concern.

To view the process map for kidney failure without desensitization, and how the process map can be improved with desensitization, click on “Download PDF” above. To learn more about other methods to increase the availability of kidney donations, see our previous blog on a flushing process that can allow the use of kidneys previously considered too damaged for donation.

 

Root Cause

Patients and Insurers Pay Big for Discarded Cancer Drugs

By ThinkReliability Staff

A recent study has found that the size of vials used for cancer drugs directly results in waste, and a significant portion of the high – and steadily increasing – cost of cancer drugs.  With most cancer medications available in only one or two sizes, usually designed to provide an amount of medication for the largest patients, many times medication is left over in each vial.

The researchers estimate that about $2.8 billion is spent by Medicare and other insurers reimbursing for medication that is discarded.

This cost – paying for medication that is literally thrown out in most cases – can be considered an impact to the property goal.  As the cost increases for drugs, it’s not only Medicare and other insurers that are impacted, but patients, many of whom pay a fixed percentage of their drug costs.  This impacts the patient services goal.  The disposal of these drugs has a potential environmental impact, impacting the environmental goal.  The impacts to the goals as a result of an issue, as well as the what, when and where of that issue, are captured in a problem outline, which is the first step of the Cause Mapping process, which develops a visual diagram of the cause-and-effect relationships (a type of root cause analysis).

The second step of the process is to begin with an impacted goal and develop the cause-and-effect relationships.  This can be done by asking “why” questions and ensuring that all the causes necessary to result in an effect are included.  In some cases, more than one cause is required to produce an effect.  In these cases, the causes are both connected to the effect and joined with an “AND”.

In this case, beginning with the property goal, we can ask “Why do Medicare and other insurers have increased costs?”  This is due to the increased cost of cancer drugs, which results from significant amount of medications being thrown away.  We can add evidence to the causes to support their inclusion in the Cause Map or provide additional information.  For example, the study found that the earnings on disposed medication made up 30% of the overall sales for one cancer medication.

A significant amount of medication is being thrown away because there is medication left over in each vial used to deliver the medication, and the leftover medication in the vials is thrown away.  Both these causes are required to result in the medication waste.  Leftover medication is thrown away because it can only be used in rare circumstances (within six hours at a specialized pharmacy).  There is leftover medication in the vials because the vials hold too much medication for many patients.  (Most medication is administered based on patient weight.)  The vials hold too much medication because many medications are provided in only one or two vial sizes.  This is true of 18 of the top 20 cancer drugs.  Providing alternate vial size is not required by regulators, whose concern is limited to patient safety or potential medical errors.  Specifically, Congress has not authorized the US Food and Drug Administration (FDA) to consider cost. Drug manufacturers select vial size based on “marketing concerns” or, effectively, profit.  The study found that providing more vial sizes for one medication would reduce waste by 84% but would also reduce sales by $261 million a year.

Several of the vials for cancer medications are sized based on a larger (6’6″, 250 lb.) patient.  According to one drug manufacturer, this is done by design, resulting from working with the FDA for a vial that would provide enough medication “for a patient of almost any size.”  At least one drug manufacturer has suggested that the full vial be administered regardless of patient size, but one of the study’s co-authors says that extra medication does nothing to help patients, so it would still be wasted.

Instead, the researchers propose that the government either mandate the drugs be distributed in multiple vial sizes that would minimize waste, or that the government is refunded for wasted quantities.  They point out that alternate vial sizes are provided in Europe, “where regulators are clearly paying attention to this issue”, says Dr. Leonard Saltz, a co-author of the study.

To view the initial outline, Cause Map and proposed solutions, please click on “Download PDF” above.  Click here to view the study and drug waste calculator.

Hospital Acquired Condition

Hospital pays hackers ransom of 40 bitcoins to release medical records

By Kim Smiley

In February 2016, Hollywood Presbyterian Medical Center’s computer network was hit with a cyberattack.  The hackers took over the computer system, blocking access to medical records and email, and demanded ransom in return for restoring the system.  After days without access to their computer system, the hospital paid the hackers 40 bitcoins, worth about $17,000, in ransom and regained control of the network.

A Cause Map, an intuitive visual format for performing a root cause analysis, can be built to analyze this incident.  Not all of the information from the investigation has been released to the public, but an initial Cause Map can be created to capture what is now known.  As more information is available, the Cause Map can easily be expanded to incorporate it.

The first step in the Cause Mapping process is to fill in an Outline with the basic background information.  The bottom portion of the Outline has a place to list the impacts to the goals.  In this incident, as with most, more than one goal was impacted.  The patient safety goal was impacted because patient care was potentially disrupted because the hospital was unable to access medical records.  The economic goal was also impacted because the hospital paid about $17,000 to the hackers.  The fact that the hackers got away with the crime could be considered an impact to the compliance goal.  To view a filled-in Outline as well as a high level Cause Map, click on “Download PDF” above.

Once the Outline is completed, defining the problem, the next step is to build the Cause Map to analyze the issue. The Cause Map is built by asking “why” questions and laying out the answers to show all the cause-and-effect relationships that contributed to an issue.  In this example, the hospital paid ransom to hackers because they were unable to access their medical records.  This occurred because the hospital used electronic medical records, hackers blocked access to them and there was no back-up of the information.  (When more than one cause contributed to an effect, the causes are listed vertically on the Cause Map and separated with an “and”.)

How the hackers were able to gain access to the network hasn’t been released, but generally these types of ransomware attacks start by the hacker sending what seems to be routine email with an attached file such as a Word document. If somebody enables content on the attachment, the virus can access the system. Once the system is infected, the data on it is encrypted and the user is told that they need to pay the hackers to gain access to the encryption key that will unlock the system. Once the system has been locked up by ransomware, it can be very difficult to gain access of the data again unless the ransom is paid.  Unless a system is designed with robust back-ups, the only choices are likely to be to pay the ransom or lose the data.

The best way to deal with these types of attacks is to prevent them. Do not click on unknown links or attachments.  Good firewalls and anti-virus software may help if a person does click on something suspicious, but it can’t always prevent infection.  Many experts are concerned about the precedent set by businesses choosing to pay the ransom and fear these attacks may become increasingly common as they prove effective.