Tag Archives: patient safety

Root Cause

Contamination found in NIH pharmacy

By Kim Smiley

The National Institutes of Health (NIH) has announced that production of drugs for use in clinical studies has been suspended after fungal contamination was found in two vials of product.  The exact source of the contamination has not been identified, but a recent Food and Drug Administration (FDA) inspection of the facility that prepares the contaminated product found multiple deficiencies, including issues with both the facility and work practices.

This issue can be analyzed by building a Cause Map, a visual root cause analysis that intuitively lays out the cause-and-effect relationships that contribute to an issue. The first step of the Cause Mapping process is to determine how an issue impacted the overall goals.  In this example, the safety goal is impacted because 6 patients were unknowingly given potentially contaminated drugs.  These patients received vials of product from the same batch as the 2 vials found to be contaminated prior to the contamination being identified.  None of the patients have shown signs of illnesses, but they will continue to be monitored. Additionally, the safety goal is impacted because some patients will knowingly be given potentially contaminated drugs.  These patients are due for treatment imminently with no alternative available and the risk of delayed treatment has been determined to be greater than the risk of using the products.  The schedule goal is also impacted as clinical trials are being delayed because the necessary medications aren’t available.

The next step is building the actual Cause Map by starting at one of the impacted goals and asking “why” questions.  So why were the drugs contaminated? It hasn’t been released what specifically lead to the fungal contamination and it may never be known, but the FDA found deficiencies within the facility that could lead to contamination. The inspectors observed workers working with sterile products with protective gear worn inappropriately so that skin and facial hair were exposed.  Issues with the facility itself was also noted, both in the design of sterile work spaces and in the cleanliness of the spaces.  Inspectors determined that the air handling system for the clean rooms wasn’t adequately designed to ensure physical separation from the other spaces.  Additionally, a filter was missing on the air handling system.  The problems with cleanliness of clean rooms included insects found in 2 of 5 clean room ceiling light bays.

The investigation into these issues is ongoing and officials are working to ensure the safety of all products.  As more information becomes available, it can easily be added to the Cause Map.  Once the specific problems with the work processes and facility have been determined, specific solutions can be implemented to address the many issues found by investigators. This problem is one that clearly doesn’t have “one root cause”, but rather many causes that contributed to the problem and more than one solution will be needed to reduce the risk of contamination to an acceptable level.

Root Cause

Care Home Residents Unable to Escape Fire

By ThinkReliability Staff

A tragic fire at a care home for residents dependent on caregivers occurred in Pingdingshan, China on the night of May 25, 2015. Of the 51 residents housed at the 130-bed care home, 38 were killed and 6 injured.

It is tempting to declare the fire as the “root cause” of the tragedy. However, doing so limits the analysis (and thus potential solutions) to only prevention of fires. While many potential improvements in fire prevention at this and other structures with high-risk occupants can be identified, it’s also important to identify solutions that increase the probability of occupants being able to successfully escape a fire.

To ensure that the investigation develops the broadest possible range of solutions, begin with the impact to the goals. In this case, the primary goal impacted was that of resident safety – 38 residents died and 6 were injured. Most residents were unable to escape, impacting the resident services goal. The care home was completely destroyed, impacting the property goal, and it was found to not meet standards, impacting the compliance goal.

Once we’ve determined the impact to the goals, we can develop a Cause Map, or a visual diagram of cause-and-effect relationships that led to the impacted goals. Beginning with one of the impacted goals (in this case the deaths and injuries), and asking “Why” questions develops the cause-and-effect relationships. In this case, the deaths were due to the severe fire at the care home. But that isn’t the only cause. After all, the fire occurred in a facility where 51 residents were (presumably) sleeping, and there were a few residents who were able to escape with their lives.

This means that the cause-and-effect relationship of “fire kills resident” is accurate, but not complete. The effect of the deaths resulted not only from the fire, but from the residents being unable to escape. This gives us two different lines of questioning and possible solutions.

A severe fire results from a fire being initiated and spreading. Heat, fuel and oxygen are required in order to initiate a fire. Oxygen is present in the atmosphere. As in most fires due to destruction of evidence, the heat (or ignition) source has not been identified, but the national work safety agency investigation did find “irregularities” in the electrical system, which could be a potential source. While the initial fuel source is not clear, the care home was constructed with highly flammable materials, which allowed the spread of the fire.

The residents in the care home were dependent on caregivers and so were generally unable to escape without help. Unfortunately help was in short supply. Although residents complained of a shortage of caregivers, it’s not clear how many caregivers were on duty at the time of the fire. Shortage of caregivers is a huge problem in China due to the large percentage of the population that is older, which resulted from the one child policy of previous generations. It’s estimated there are 200,000 caregivers for the elderly in China, and 10 million are needed. In addition, the national work safety agency investigation found that the escape routes in the care home were poorly designed, making it difficult for anyone to escape.

After the tragedy, Chinese Premier Li Keqiang called on others to “draw lessons from the accident, checking all potential safety hazards to avoid similar incidents.” To avoid deaths from fire, that involves not only reducing the risk of fire, but making sure all people, regardless of ability, are able to escape.

To view the analysis of this issue, click on “Download PDF” above. To read about an arson at a care home in Australia that killed 11 and spurred a law requiring installation of automatic sprinkler systems, click here.

 

Root Cause

Identifying and Preventing Causes of Lab Errors

By ThinkReliability Staff

A man was mistakenly told he had HIV. A baby who died from a blood disorder that could have been treated during pregnancy, but wasn’t because the routine blood screen came back clear. A little girl who had to receive a second transplant after the test to verify her acceptance of a new organ was run incorrectly. These are just some of the cases mentioned in a watchdog report about how laboratory errors and weak oversight put patients at risk.

There are 7 to 10 billion medical laboratory tests run in the US every year. Lab tests influence about 70% of medical decisions. Having the wrong information from these tests can be deadly, and there is no good data about how many lab tests may be inaccurate, or may be negitively impacting patient safety. Laboratories are generally overseen by accrediting organizations but the results are almost always private, and there have been recent cases where federal regulators have had to step in because serious deficiencies in lab processes were identified.

The risk isn’t just for patients. An employee was infected with HIV and hepatitis C after a machine malfunctioned, splashing contaminated blood product onto her face. The employee had warned her boss previously that the machine was broken and cross-contaminating samples. Patients can also receive wrong information that isn’t harmful to their physical health but causes all sorts of other problems, such as incorrectly run paternity tests that improperly rule out a man as the father of a child.

The process involved in laboratory testing – from taking a specimen from a patient to delivering the results – is complex, and there are potential issues at each step that can lead to inaccurate results. These causes can be visually diagrammed in a Cause Map, or a visual cause-and-effect diagram. (To view the Cause Map, click “Download PDF” above.) In this case, potential causes of lab errors are captured and analyzed for potential solutions. These causes include labeling of samples, time and storage conditions of the samples, use of proper (and non-expired) products to treat the samples, and calibration of the machines used for the testing.

Actions that reduce the risk of inaccurate lab results should be in place at all labs, but even with a well-planned process, mistakes can happen. That makes the addition of checks and oversight into the process incredibly important. Says Michael Baird, the chief science officer and laboratory director at DNA Diagnostics Center, “I will agree that mistakes are something that can happen whatever you do. You just need to have the appropriate controls in place for when a mistake happens, (so) you can catch it before it goes out the door.”

For example, at the lab Baird runs, samples used for DNA checks are run independently by two different technicians and when a man is ruled out as the father of a child, there is a double-check in place. Other labs have incorporated alert systems for time-sensitive specimens and have hired technical directors responsible for overseeing the labs.

There are also steps patients themselves can take to minimize the impact on their safety from potential lab testing errors. First, ensure that any samples taken are labeled immediately and with accurate information. If you’re at all unsure about a test result, get a second opinion at a different lab. Complaints about a lab should be directed to state health officials.

To view the Cause Map addressing potential causes of laboratory errors, click “Download PDF”. To learn more, read the watchdog report.

Root Cause

Prisoner escapes from hospital

By ThinkReliability Staff

A recent prisoner escape from city custody in Virginia was only one of four attempted escapes in the US over 8 days related to seeking medical care.  Examining the cause-and-effect relationships shows what led to the prisoner escape and can provide insight into improvements to reduce the risk of it happening again.  These cause-and-effect relationships can be diagrammed visually in a root cause analysis, or Cause Map.

The analysis begins by capturing the what, when and where of the problem.  In this case, the issue being analyzed is the escape of a prisoner from a public hospital in Alexandria, Virginia March 31, 2015 at about 3:00 a.m.  Along with the where, we capture what was happening at the time.  In this case, the patient was receiving medical care after a suicide attempt.  It’s also helpful to capture any differences.  Differences could be in the location, date, time or task being performed.  In this case, a few things stand out from a summary reading of the media reports available.  First, the city jail prisoner was being treated at a public hospital, and second, one of the guards responsible for the prisoner was taking a bathroom break.

These differences may or may not be causally related to the issue, but provide potential causes to consider. As mentioned, there were four prisoner escapes during a week related to medical care.  On the same day, a New Orleans prisoner escaped from a van transporting prisoners to a hospital.  The previous day, a New Jersey prisoner escaped from a hospital, and a week prior, a West Virginia psychiatric hospital patient facing murder charges escaped.

As physical and procedural security at prisons improve, fewer prisoners are escaping from the facilities themselves.  Many times, being removed for medical care is the best opportunity.  Federal prisons, which provide on-site medical care, have far fewer escapes than other facilities.  From 1999 to 2001, only one of 115,000 federal prisoners escaped.

A single trip for medical treatment itself may not be to blame for the escape attempts, but repeat trips to the same medical facility may increase the risk.  Says Kevin Tamez, inmate advocacy consultant, “Very rarely do these guys go to the hospital for treatment and all of a sudden they decide they’re going to escape.  What happens is, traditionally, inmates go to the hospital for treatment . . . they come back to the facility and they start telling other inmates . . . There is nobody more ingenious than an inmate.  They have nothing to do all day but sit around and think things up. There are ways of minimizing it, but there’s never a way to prevent it.”

Having only one guard instead of two, due to a bathroom break, is problematic for obvious reasons.  It’s far more difficult to overwhelm two guards than one.  “From a safety perspective it’s always good to have two people there,” says Gary Klugiewicz, a consultant/ trainer for law enforcement & correctional officers.  The amount of time the guards were watching this prisoner at the hospital (4 days, for reasons that are unclear) may have also played an impact.  It’s hard to keep your guard up for that amount of time.

The U.S. Marshals, who had responsibility for the prisoner at the time, will be reviewing their procedures to look for opportunities for improvement.  Experts suggest that enlisting hospital security to fill in, rather than leaving just one guard in place, may help.  Because the secure healthcare facilities in federal jails allow so many fewer escapes, using these instead of public hospitals may reduce the risk of escape.  However, there’s still the problem of transporting inmates, which is another high escape potential.

To view the Cause Map of the prisoner’s escape, click on “Download PDF” above.  Or click here to learn more.

Root Cause

What Caused an HIV Outbreak in Rural Indiana?

By Kim Smiley

A public health emergency has been declared after 79 cases of HIV were confirmed in rural Indiana, the worst outbreak of HIV the state has ever seen.  Individuals potentially at risk have been encouraged to get tested and the number of cases is expected to rise as more cases are identified. The epidemic has been tied to intravenous drug use, although other risky behaviors may also have spread the disease.

In order to effectively fight this HIV epidemic and hopefully reduce the risk of outbreaks in the future, the factors that have led to these HIV cases needs to be understood. This region has been struggling with the use of Opana, a powerful opioid painkiller, for years.  Opana is commonly injected and health officials believe that the use of dirty needles has been the primary driver of HIV infections although unprotected sex was also a potential pathway for infection for some.  Needle exchange programs are illegal in Indiana and access to clean needles is limited so needles are being shared.  In an environment where needle sharing is common, it takes only one individual infected with HIV to rapidly spread the virus to many other drug users.

HIV is also more likely to be spread if infected individuals are unaware that they are infected and are not being treated.   Identifying an individual who has contracted HIV as early as possible and providing treatment helps prevent the disease from spreading because an HIV-positive person who receives sustained treatment is drastically less infectious, even if they continue to engage in high risk behaviors. Access to healthcare and HIV testing is limited in this region where many residents are uninsured and may lack transportation. Heroin use has long been tied to HIV, but users of Opana (a licensed pharmaceutical) may not have been fully aware of the potential risk from sharing needles.

Now that the HIV epidemic has been identified, healthcare officials are working to reduce the risk of more infections by providing testing and treatment.  One physician is even driving door to door, offering free HIV testing and trying to educate residents on drug addiction and HIV treatment.  Austin, Indiana has established its first ever HIV clinic to provide testing, counseling and treatment.  Targeted resources to help educate residents on drug use and to assist addicts seeking to get clean are also being provided.  The governor of Indiana has approved a short term needle exchange program.  Indiana has also created a public awareness campaign to help inform people about the risks of intravenous drug use.  Drug addiction is a notoriously difficult problem to battle, but the additional resources should help reduce the rate of future HIV cases.

To view a high level Cause Map, a visual root cause analysis, of this issue, click on “Download PDF” above.

Root Cause

Hospital reduces neonatal fatalities by 50%

By Kim Smiley

Infant mortality rate is often used as an indication of a nation’s health and social condition.  When reviewing the data for different countries, it becomes obvious that for a wealthy, developed country, the United States has a high infant mortality rate. According to the CIA World Factbook, the US infant mortality rate is 6.2 deaths per 1,000 births, which is nearly twice that of France, Italy and Spain. Additionally, the US ranked 60 for maternal deaths in a study for the Institute for Health Metrics and Evaluation.

The good news is that healthcare providers are working to improve care and help reduce preventable injuries and deaths during childbirth.  Obviously, access to prenatal care, overall health of the mother and other factors play a role in birth outcomes, but some relatively simple solutions targeting labor and delivery care have proven to dramatically increase birth outcomes.  A new report “Solutions in Sight” by the nonprofit Public Citizen lists some of the successes in improving birth outcomes.

One particularly impressive case is that of Ascensions Health, which reduced its neonatal fatality rate by 50% across its 43 hospitals by implementing relatively cheap, common-sense solutions.  Ascension did a number of things to help improve birth outcomes such as improving training and communications.  Drills were done to practice how staff should respond in a variety of emergency situations to help medical personnel identify and quickly respond to potentially dangerous scenarios.  There was also focus on communication between personnel to help ensure there were no misunderstandings in high pressure situations and to encourage all staff members to speak up if they perceived a dangerous situation.

Additionally, they worked to develop “bundles” of services, which are packages of procedures that have been shown to produce the best results.  Bundles are essentially guidelines for how staff should respond in a variety of situations.  There was also an emphasis on reducing C-section deliveries that weren’t medically necessary because these types of births are associated with a higher rate of complications. None of these solutions were earth-shattering, but they have proven effective when consistently implemented.

In additional to the clear benefit of saving lives and reducing the number of potentially life-long injuries, improving birth outcomes has economic benefits.  Better birth outcomes reduce the likelihood of expensive lawsuits. This example is a classic win-win where doing the right thing actually saves money in the long run as well.

Many of us do not spend our days delivering babies, but this example has many lessons that can be applied across industries.  Learning how to provide effective, realistic training can dramatically improve performance.  Empowering employees at all levels to speak up when something doesn’t look right can save lives, whether it’s in a factory or a hospital.  Formally documenting and using best practices so employees can benefit from others’ experience can streamline many processes and reduce preventable errors.  Sometimes the simple solutions really are the most effective.

Typically, a Cause Map is built when something has gone wrong, but it can also be used as a proactive tool to help understand why something has gone right.  To view a high level Cause Map of this example, click on “Download PDF” above.  Another example of a proactive, positive Cause Map is the Miracle on the Hudson, where all passengers survived a plane landing on a river.

Root Cause

After Patient Death, CMS Surveyor Declares “Immediate Jeopardy” To Patient Safety

By ThinkReliability Staff

From the moment a patient arrived at an endoscopy clinic in New York on August 28, 2014, things didn’t follow the usual procedure.  The patient brought her own ear, nose and throat physician (ENT) to accompany her into surgery for an esophagogastroduoudenoscopy (EGD), though the ENT did not have privileges at the facility.  The patient signed a consent form for anesthesia, and the EGD and her vital signs were taken, though it appears her weight was either not taken or not recorded.

After a time out that was initiated by the endoscopy technician (as opposed to the anesthesiologist, as required by policy) for the EGD, the patient was administered Propofol for sedation.  After the patient was sedated, the ENT attempted to perform a nasolaryngoscopy, despite not having facility privileges or a record of patient consent, but the initial attempt appears to have been unsuccessful.  After the EGD was completed, the ENT performed another nasolaryngoscopy beginning at 8:28 AM and ending (per interview records) at 8:30 AM.

By that time, the patient’s condition was quickly deteriorating.  Her blood pressure had dropped from its pre-procedure level of 118/80 to 84/40, her pulse from 62 to 47, and oxygen saturation from 100% to 92%.  Both the Cardiac Arrest Record and the Endoscopy Code Blue Record indicate that at 8:28 AM (the same time the second nasolaryngoscopy was beginning) the patient went into cardiac arrest/ ventricular tachycardia and measures were taken for resuscitation (including assisted ventilation, chest compressions, and administration of epinephrine and atropine).

The record of the surgery note that the laryngoscope was withdrawn at 8:30 AM, at which time cardiopulmonary resuscitation (CPR) was undertaken.  The patient was resuscitated and transferred to a hospital, where she died on September 4, 2014.  The cause of death from the autopsy report was anoxic encephalopathy (brain damage) caused by hypoxic cardiac arrest (oxygen deprivation).

The day prior to the patient’s death, a surveyor from the Centers for Medicare and Medicaid Services (CMS) declared “Immediate Jeopardy” due to “significant findings . . . which compromised patient safety”.  Specifically, the surveyor noted that the facility had risked patient safety by allowing a doctor without privileges to be allowed in the operating room and perform a procedure, and not obtaining consent or performing a time out for a procedure that was performed.

The facility quickly submitted a corrective action plan that revised procedures allowing visitors to the facility, ensuring informed consent and time out procedures are used before every procedure, and providing training on these updated procedures to staff.  Immediate jeopardy was removed on 9/5/14, although the facility was still considered out of compliance with CMS requirements, and was given until March 2 to maintain its certification.  (CMS has not released whether the facility has been successful.)

A lawsuit is underway that may provide more detail as to how the CMS findings caused (or didn’t cause) the patient’s death.  At this point, what is known can be captured in a timeline (for a chronology of events) and a Cause Map (to capture the cause-and-effect relationships that led to the impact to the goals) to start organizing and presenting information logically.  As more information is available, the Cause Map can be updated.

To see the timeline and initial Cause Map, click on “Download PDF” above.

 

Root Cause

Duodenoscope Superbug Outbreak: What You Need to Know

By ThinkReliability Staff

The bacteria involved in the outbreak are deadly: The recent outbreak in California involves Carbapenem-resistant Enterobacteriaceae (CRE). According to Centers for Disease Control and Prevention (CDC) Director Tom Frieden, “CRE are nightmare bacteria. Our strongest antibiotics don’t work and patients are left with potentially untreatable infections.” About 50% of patients with a CRE bloodstream infection will die. At least 7 people were infected at the UCLA Medical Center from October 2014 to January 2015, two of whom died.

Duodenoscopes are frequently used: Duodenoscopes are thin flexible scopes with a light and miniature camera attached, used in endoscopic retrograde cholangiopancreatography (ERCP) procedures to diagnose and treat liver, pancreas and bile-duct problems. The FDA hasn’t recalled the scopes because, according to US Food and Drug Administration (FDA) spokeswoman Leslie Wooldridge, “The FDA feels that the lifesaving nature of ERCP, performed on more than 500,000 patients annually in the U.S., makes it important for these devices to remain available.”

Duodenoscopes have been causing problems with infection for a long time: The President of the American Gastroenterological Association, John Allen, M.D. says that duodenoscopes have been causing superbug infections since 1987. He says, “It certainly is disturbing that a fundamental design issue with these scopes would cause problems for this long.” 16 patients developed serious infections after the use of a duodenoscope in France in 2008-2009, as reported in the journal Endoscopy. A 2013 outbreak infected 39 patients in Chicago (after which a duodenscope was destroyed because decontamination efforts were unsuccessful). The FDA received 75 reports involving 135 patients related to duodenoscope contamination from 2013 to 2014. 18 patients in North Carolina have been infected by CRE from duodenoscopes so far this year (2 of those patients have died).

Cleaning duodenoscopes is really difficult: The two duodenoscopes found to have been infected in the California outbreak were “sterilized according to the manufacturer’s specifications”, says the medical center. The FDA issued a warning February 19, 2015, noting that “Recent medical publications and adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly. Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it.” Effectively, even following the instructions may not fully sterilize the duodenoscope.

The FDA is working on label changes for duodenoscopes: According to Dr. William Maisel, chief scientist for the FDA’s Center for Devices and Radiological Health, “We are working to expedite modifications to the label. We are also talking about updating the risk information.” The FDA recommends that hospitals “consider taking a duodenoscope out of service until it has been verified to be free of pathogens if a patient develops an infection with a multidrug-resistant organism following ERCP, and you suspect that there may be a link between the duodenoscope and the infection.” The FDA has also asked duodenoscope manufacturers to prove that their recommended methods provide adequate disinfection.

Some worry that may not be enough: Says Mary Logan, chief executive of the Association for the Advancement of Medical Instrumentation, “the devices need to be designed better, the instructions need to be more clear, the hospitals need better training, and adequate time needs to be given in hospitals to ensure sterility is top notch.” The CDC is working with duodenoscope manufacturers on a reprocessing (cleaning and sterilizing for reuse) protocol for the instruments. In the meantime, the UCLA Medical Center has turned to gas sterilization and has reported no new infections since the switch. However, the procedure is highly toxic and poses a risk to staff and patients. The FDA says it is “not something that we routinely recommend”.   Hospitals in North Carolina are screening patients for CRE and isolating infected patients, as well as decontaminating their rooms after they’re released. They’ve also enhanced the cleaning and sterilization processes for duodenoscopes.   At least one hospital is quarantining each device for 48 hours to verify by culture that it’s free of CRE and other infections.

It’s all part of a much bigger problem: Some worry that the time and money being spent dealing with the real, though comparatively small, risk of infection from contaminated duodenoscopes takes away from the broader effort of preventing all hospital infections, especially those that are resistant to antibiotics. The CDC has determined that about 1 in 25 patients acquire a hospital-acquired infection during a hospital stay (see our previous blog on this issue). Says David Ropeik, a consultant in risk perception and communication, the concern over this issue is “going to flare up and then it’s going to go away” but “the world will still be at serious peril from a risk we don’t take seriously, which is antibiotic resistance. Germs are figuring out how to resist our antibiotics faster than we can make new ones.”

If you would like to learn more, attend our FREE webinar “Healthcare Case Study – Hospital-Acquired Infections” on Thursday, March 5, 2015 at 11 am EST.  Register here.

Root Cause

Explosion, Deaths at Maternity Hospital Follow Gas Leak

By ThinkReliability Staff

A gas tanker was providing fuel to a maternity hospital in Mexico City when the gas workers discovered a leak. They contacted the fire department, had the hospital evacuated, and attempted to put out the leak. Unfortunately, the leaked gas exploded, killing at least 2 nurses and 2 babies, and leveling most of the hospital.

Dozens more infants, patients and nursing staff were injured, along with the three gas workers present at the scene. The gas workers have all been arrested, though the charges against them have not been released. While it appears that the workers are being held responsible for the tragedy, providing an objective, factual analysis as to what happened can provide useful information to reduce the risk of the issue happening again.

When performing a root cause analysis of an issue (as we will do here in a Cause Map), it’s important to first capture the impacts to the organizational goals as a result of the incident being investigated. In this case, the patient safety goal is impacted because of the deaths of two infants and the injuries to dozens of patients. The safety of hospital employees was impacted due to the deaths of two nurses and injuries to many more. Additionally, the safety of the gas company employees was impacted because all three of the gas workers were injured.

The environment was impacted due to the gas leak. The compliance goal was impacted because the three workers were arrested. The patient services and operations goals were impacted by the evacuation from the hospital (which is very difficult on patients and staff, although it likely saved many lives in this case). The property goal is impacted because of the severe damage to the hospital and the labor goal is impacted by the rescue efforts. (Hospital neighbors are reported to have provided considerable assistance to the rescue efforts at no small risk to themselves.)

Any time deaths or injuries result from an explosion, it is important not only to determine what caused the explosion, but whether the response could have been improved. In this case, the explosion occurred while the hospital was being evacuated, though a specific timeline of the leak, evacuation and explosion has not been released. Further analysis into the evacuation will help determine whether improvements could have saved lives.

In the case of the explosion, the fuel was provided by the leaked gas. Adequate oxygen was present in the air, and the ignition source (heat) could have been provided by hospital operations (the gas was being delivered near the hospital kitchen) or potentially by work being done to repair the leak (such as static or a spark). The gas leaked due to a faulty gas delivery hose. When a faulty part contributes to a tragedy such as this one, it’s important to determine not only how the damage occurred (if possible), but whether inspections or maintenance could have reduced the risk of an incident. Clearly if the hose had been discovered to be faulty and replaced before the delivery took place, the risk of an explosion would have been greatly decreased.

A broader issue for the entire country is the question of why gas leaks and explosions are fairly common. Part of this is because there is no infrastructure to pipe gas underground and it instead has to be delivered by truck. A similar incident involving a hose issue on a gas truck killed three in Queretaro in July last year. The company that provided the gas to the hospital in this case says that it has 1,000 trucks that deliver gas to over 80% of the country. With such a large distribution network, accidents are bound to happen. However, clearly more effort needs to go into making sure that the impact on human lives is reduced.

Root Cause

Non-Sterile Product Administered Intravenously to At Least 40 Patients

By ThinkReliability Staff

A non-sterile product that was meant for clinical simulation (training) only was administered intravenously (via IV) to at least 40 patients, one of whom died and at least 17 of whom became seriously ill. Because the death was in a hospice patient, it was not determined definitively that it was caused by the solution. The Food and Drug Administration (FDA) is taking no chances – after the reports of patient injury, the FDA had released an alert warning medical practitioners not to use the product “for clinical simulation” on patients. The company that manufactured the products later implemented a recall.

Whether or not the patient death can be blamed solely on the IV use of a non-sterile product, administering a non-sterile product to a patient is clearly an impact to the patient safety and patient services goals. At least 17 injuries (which typically were discovered very quickly after use of the non-sterile IV product) have been tied to the error. The recall is a product goal to the manufacturer – which does not produce any sterile products. The investigation by the FDA is an impact to the labor goal. How these goals were impacted and what is being done or recommended to prevent these impacts can be captured in a Cause Map, a visual root cause analysis diagram of cause-and-effect relationships. (To view the Cause Map, please click on the image above.)

Patient safety was impacted because of the administration of a non-sterile IV product to patients. These patients were receiving saline product via IV to treat various medical conditions (dehydration, for example) and the product was not sterile. Because the product was for training purposes only, it was not meant to be sterile. Healthcare facilities that administered the solution said they were unaware that it was a non-sterile product.

The non-sterile product was delivered to the facility, whether by the ordering or delivery of the incorrect product. According to Dr. Alexander J. Kallen, the medical officer at the Centers for Disease Control and Prevention (CDC), “It seems like it’s not just one single mistake. There could have been instances where ordering was done by office staff who didn’t know the difference, as well as instances where the right product was ordered but they received the wrong stuff.” It does appear that the facilities in question (which are located in Florida, Georgia, Idaho, Louisiana, North Carolina, New York, and Colorado) all received the product from the same distributor, indicating a likely issue associated with the distributor’s delivery or ordering process. A nationwide shortage of sterile saline solution may have led to the use of additional suppliers, contributing to the confusion.

Even if the wrong product is delivered to a healthcare facility, there are still multiple opportunities to identify the problem before patient harm results. In this case, had anyone at the healthcare facility looked at the product – which was labeled “For clinical simulation”, the products could have been removed from the facility, as did happen at some facilities, which returned the non-sterile product.

The FDA has requested that all healthcare facilities and product distributors individually inspect saline product to be administered to patients to verify that it is sterile and not intended for training purposes. The manufacturer of the training products has asked its distributors to add language to its advertisements specifying that they are for training, and are not sterile for patient use. In the meantime, the FDA is working with manufacturers of sterile saline to increase the supply, and has provided links to available supply on their website.

What should you do? If you are involved in an IV transfusion, either as a patient or a practitioner, check what’s being delivered and ensure it matches your doctor’s order. Go to the FDA’s site to learn more about the recall, investigation or saline shortage.