Monthly Archives: April 2016

Root Cause Analysis

NIH suspends work at two facilities

By Kim Smiley

Research has been suspended at two National Institutes of Health (NIH) facilities – a National Cancer Institute laboratory working on cell therapy production and a National Institute of Mental Health facility that makes positron emission tomography materials – over concerns about patient safety. A panel of experts determined that these facilities were not in compliance with quality and safety standards and they are shut down pending a review and any necessary upgrades.

A Cause Map, a visual format for root cause analysis, can be built to help understand this issue.  The first step in the Cause Mapping process is to fill in an Outline with the basic background information for an issue, along with how the issues impacts the overall goals. Thankfully, no patient harm has been identified as a result of issues at the facilities, but the potential for patient harm existed and potential impacts should be included on the Outline. No new patients will be enrolled in the affected trials until the issues are resolved and this is an impact to the schedule/operations goal. Once the Outline is complete, the Cause Map is then built by asking “why” questions and the answers are laid out to visually show the cause-and-effect relationships. (Click on “Download PDF” to see a completed Outline and high level Cause Map of this issue.)

So why was work at two NIH facilities shut down? A little background is needed to understand this issue. In April 2015, fungal contamination was found in products that were supposed to be sterile that were prepared at a different NIH facility, the Clinical Center’s Pharmaceutical Development Service. The investigation into the contaminated product found multiple deficiencies, both in the facility itself and in work practices. The deficiencies included a filter missing in an air handling system and insects found in two light bays in clean rooms. (Read our previous blog to learn more.) Following this issue, the director of NIH appointed a panel of experts to review safety compliance at all other NIH facilities that produce sterile or infused products for administration to research participants.

The panel’s evaluation is still underway, but preliminary findings determined that the two facilities in question are not in compliance with quality and safety standards and production has been suspended as a result.  The panel found that NIH has many outdated or inadequate facilities and that personnel lack expertise on applicable regulations, but no specific details about the deficiencies found have been released. NIH plans to do a rigorous review to identify and correct issues found before these facilities resume manufacturing sterile products. No timeline has been given at this point.

The final step in the Cause Mapping process is to identify and implement solutions to reduce the risk of similar errors reoccurring in the future. In addition to correcting the deficiencies found at these facilities, NIH is working on creating more oversight to help ensure manufacturing facilities are in compliance with safety regulations. The panel recommended the creation of both an outside hospital board to oversee the clinical center and a new central office to coordinate research quality and safety oversight.

Only time will tell how effective these solutions prove to be, but I find it promising that NIH proactively reviewed all of the facilities that produce sterile or infused products for administration to research participants following the fungal contamination issues last year.  It may be painful and embarrassing to suspend work at facilities, but the process is at least moving in the right direction if problems can be corrected before patients are harmed.

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

Family of Sepsis Victim Fights for Better Care

By ThinkReliability Staff

New York state has become a leader in identifying and treating sepsis. But it wasn’t always this way. On April 1, 2012, a twelve-year-old boy named Rory Staunton died from sepsis in a New York hospital (the subject of a previous blog). There were multiple opportunities that could have more quickly identified his sepsis, and potentially saved his life. After his death, Rory’s family founded the Rory Staunton Foundation For Sepsis Prevention. Part of the foundation’s mission is to improve diagnosis and treatment protocols for sepsis.

The foundation landed a success when New York state adopted what are known as “Rory’s Regulations” on December 31, 2013. These regulations require “health care providers to develop and implement protocols to rapidly diagnose and treat sepsis infections”. In addition, the state adopted hospital pediatric care regulations which specifically addressed many of the causes identified in Rory’s case. These include requirements to:

– Review of test results by a clinician familiar with the patient’s case: Blood tests ordered to be run immediately were not reviewed by the doctor who ordered them. Although initial tests showed abnormalities within an hour of Rory’s arrival, these results were not provided to the emergency department at all.

– Provide test results to the primary care provider: The test results were not provided to Rory’s primary care provider.

– Improve communications of test results to patients and parents: The test results were not provided to Rory’s parents

– Keeping patients in the hospital while awaiting critical test results: Rory had already left the hospital when the test results arrived. Because the results of the test were a matter of life or death, had his discharge been delayed while awaiting the results, the outcome may have been different.

Even with ensuring that test results make it into the right hands, diagnosing and treating sepsis is difficult. Rory’s Regulations also require developing protocols that will assist in sepsis detection and treatment. An international task force released updated definitions of sepsis and septic shock, as well as clinical guidance, in February 2016. The Centers for Medicare and Medicaid launched a new core measure for fiscal year 2016.

Another mission of the foundation is to increase public awareness and understanding of sepsis. The foundation requested the Centers for Disease Control and Prevention help them in this mission. The CDC launched its new sepsis website on May 29, 2014.

While New York’s regulations seem to have been a success (the state’s Department of Health estimates they will save at least 5,000 lives each year), the foundation isn’t stopping there. Their stated goal is to have similar regulations in place across the US by 2020.

To view the cause-and-effect relationships and the associated solutions laid out visually in a Cause Map, please click on “Download PDF” above. Click here to learn more about the Rory Staunton Foundation For Sepsis Prevention.

Hospital Acquired Condition

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.

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!