Root Cause

Heavy Metal Toxicity Professor Killed by Mercury Exposure

By ThinkReliability Staff

Professor Karen Wetterhahn knew firsthand how dangerous heavy metals could be.  Her research involved determining the biologic toxicity of heavy metals.  The chemical she was working with on August 14, 1996, was particularly dangerous.  Dimethylmercury, used as a reference standard, is lethal at about 400 mg, a few drops.  This classifies it as “supertoxic”.  When she spilled a few drops on her gloved hand, she assumed the precautions she had taken (the use of disposable latex gloves and a ventilated hood) were adequate.  She was incorrect, but would not know it for quite a while.

It took 149 days before Professor Wetterhahn began to exhibit neurological symptoms, 154 days before she sought care, and 168 days before chelation therapy began.  Chelation therapy involves the use of agents that form chemical bonds with metal ions to form a water-soluble complex, allowing the heavy metal to be excreted from the body.  However, according to a report on Professor Wetterhahn’s death in the New England Journal of Medicine (NEJM), chelation treatment delayed after exposure “is of little or no clinical benefit”.

Professor Wetterhahn became unresponsive on February 12, 1997 and died on June 8.  As a result of her poisoning, more research has been done to better determine the causes that led to her death, as well as determining actions that can reduce the risk of more deaths from mercury poisoning.  We can look at these causes in a Cause Map, or visual root cause analysis.

The death of Professor Wetterhahn was due to accidental dimethylmercury poisoning, which is lethal in just a few drops, and ineffective chelation therapy (which may have been able to reduce the impact had it been administered immediately after exposure).  Due to the latency of neurological symptoms and the belief that protections taken while working with dimethylmercury were adequate, this did not occur.

Based on later research and testing, it was determined that Professor Wetterhahn was exposed through her skin when she dropped a few drops of dimethylmercury on her glove.  The disposable latex gloves she was wearing were later found to result in permeation to the skin in a matter of seconds.    The Material Safety Data Sheet (MSDS), which defines necessary personal protection for working with various chemicals, specified only “wear appropriate chemical-resistant gloves”.  The use of a plastic-laminate chemically-resistant glove was found to result in no permeation after four hours and should be used rather than disposable latex while working with this chemical.

It is also possible that mercury exposure occurred via inhalation. Although Professor Wetterhahn was using a ventilated hood, dimethylmercury is extremely volatile and could have created an inhalation hazard when it was spilled.

Many organizations would be tempted to identify the spill of the dimethylmercury as the root cause and end the investigation there.   However, basing personnel safety solely on attempting to prevent spills does not provide adequate protection.  In this case, the risks of using dimethylmercury were found to be so high that an alternative is recommended unless absolutely necessary.  If the use of the supertoxic compound is found to be essential, very specific personal protection equipment is called for as well as seeking treatment immediately after possible exposure.

In the NEJM report, the authors state “Before she lapsed into a vegetative state, the patient requested that her case be presented to the general medical community, to scientists working with mercury, and to toxicologists, in the hope of improving the recognition, treatment, and prevention of future cases of mercury poisoning.”   By examining all the causes and possible solutions, it is hoped that all chemical work can be made safer, in honor of Professor Wetterhahn.

To view the Outline, Cause Map and timeline of this issue, please click on “Download PDF” above.

Root Cause

Alleged Radiology Misreading Results in Removal of Cancer Patient’s Healthy Kidney

By ThinkReliability Staff

On January 17, 2013, a radiologist discussed the results of a CT scan with an urologist.  The CT scans identified cancer in the kidney of an urologist’s patient.  Two months later, the patient underwent surgery to remove the kidney.  The kidney was examined by a pathologist, who declared it cancer-free.  The wrong kidney had been removed, allegedly due to a misidentification by the radiologist.

Wrong-site surgeries like this one can lead to severe patient safety consequences, as well as severe financial and regulatory consequences for the doctors and healthcare facilities involved.  This is why surgery performed on the wrong body part has been identified as a “never event“, or an event that should never occur in a healthcare facility.

Even with this designation and the known seriousness of the issues, wrong-site surgeries continue to occur.  The Joint Commission estimates that the prevalence of wrong-site surgeries in the United States is as high as 40 per week.

Clearly, action must be taken to reduce the risk of wrong-site surgeries.  To identify areas of potential improvement, it can help to look at an example of an actual case of wrong-site surgery to determine lessons learned.  We will examine the case of the wrong kidney being removed as an example of issues that can lead to wrong-site surgeries using the Cause Mapping method of root cause analysis.

It’s important to identify the impacts to the goals as a result of an incident.  In this case, the patient safety goal was clearly impacted as the patient now has only 3/4 of a kidney remaining, with the potential to cause serious health impacts.  (A portion of the cancerous kidney was removed in a later operation.)  The compliance goal is impacted because of the occurrence of a “never event” as discussed above.  The patient services goal is impacted due to the removal of the wrong (healthy) kidney.  The radiologist and urologist involved in the issue have been sued for more than $1 million as a result of the issue.  If all these issues received similar lawsuits, the costs to the health system would be over $2B a year.

Once the impacts to the goals are identified, asking “why” questions develops the cause-and-effect relationships that led to the issue.  In this case, the removal of the wrong kidney is alleged to have resulted from the radiologist misreading the CT scan that identified the kidney with cancer and passing that information on to the urologist who performed the surgery.  Clearly the urologist’s physical exam (if any) did not adequately determine the site of the cancer.

To better understand the steps that led to the surgery, they can be diagrammed in a Process Map.  A Process Map lays out a process in much the same way that a Cause Map visually lays out cause-and-effect relationships.  A very high level overview of the process used in this case is shown on the downloadable PDF.  What’s important to note is that an incorrect reading of a CT scan or other diagnostic tool propagates through the process.  With no second opinions or double checks built in, the diagnosis of cancer in the left kidney was the only information the urologist had to determine the operating site.

There are of course other errors in the surgical preparation procedure that can also cause wrong-site surgeries.  (Many of these errors are identified in our proactive write-up on wrong-site surgeries.)  As stated by Mark R. Chassin, M.D., President of The Joint Commission, “Wrong site surgery events occur basically because none of the processes that we use in taking care of patients is perfect.”  Equally important is that the people performing the processes are not perfect.  Although both processes and people’s performance can be improved, it will never reach perfection.  For this reason, adding double checks and second opinions into processes is essential to reduce the risk of the one mistake resulting in a devastating patient safety impact.  In this case, having a second opinion on the CT scan, or having the physician re-identify the area with a physical exam prior to surgery (if possible) may have identified the error prior to removal of a healthy kidney.

View the Cause Map and process map by clicking on “Download PDF” above.

Root Cause

“Artificial Pancreas” May Dramatically Improve Management of Type 1 Diabetes

By Kim Smiley

As many as 3 million Americans have type 1 diabetes and for many managing the autoimmune disease requires constant vigilance.  Patients have to carefully monitor what they eat and their blood sugar levels, often pricking their fingers and injecting insulin multiple times a day.  The number of people diagnosed with type 1 diabetes has been increasing, but there is some good news.  There is no cure for type 1 diabetes, but a new device, an artificial pancreas, may make managing the disease significantly simpler.

Type 1 diabetes is caused when the immune systems attacks insulin-producing cells in the pancreas so the body can no longer produce adequate insulin.  Insulin is needed because it works to allow sugar to enter cells where it is used for energy, reducing the levels of sugar in the blood stream.  Sugar builds up in the blood when food is consumed and from natural processes in the body.  Without enough insulin, blood sugar levels will continue to increase.  High blood sugar can damage major organs and can have significant impacts on long-term health.  Low blood sugar is also dangerous and can quickly become a life-threatening emergency so patients with type 1 diabetes are constantly working to keep blood sugar within acceptable levels.

The artificial pancreas works by monitoring blood sugar levels every 5 minutes and using two pumps to deliver two different hormones (insulin to lower blood sugar levels and glucagon to raise blood sugar) as needed with minimum intervention required by the user.  The current version of the artificial pancreas consists of three parts (two small pumps and iPhone contacted to a continuous glucose monitor) but there are plans to simplify the device in the future.  The components connect to three small needles that are inserted in the patient to allow blood sugar levels to be monitored.  Insulin pumps currently used by many type 1 diabetics can only inject insulin and require more input from the user, so the artificial pancreas is a significant improvement over currently available technology.

The artificial pancreas is still in the development stage and needs additional testing and modification prior to becoming widely available for patient use.  The first test was done using about 50 patients (20 adults and 32 teenagers) who wore the new device for 5 days.  The results were very promising, but more testing will need to be done. During the 5-day test, the patients had lower blood sugar levels overall and the device simplified management of the disease.  Researchers reported that the patients didn’t want to return the devices because they worked so well. The next step is to have patients use the device for a longer time period.  It’s essential to ensure that the device is very robust, because the consequences can be dire if it fails.  Once the design is finalized, the hope is to seek FDA approval and have the artificial pancreas available in about 3 years.

To view a Cause Map of this issue, click on “Download PDF” above.

Root Cause

5.5 Million Cases of Norovirus are Spread Via Food Each Year

By Kim Smiley

Norovirus outbreaks on cruise ships may make exciting headlines, but the reality is that only one percent of norovirus outbreaks occur on the high seas.  About 20 million people in the US are sickened by noroviruses in the US each year and one of the most common transmission paths is via food.  Food-borne norovirus is estimated to be responsible for 5.5 million cases of norovirus annually in the US.

A Cause Map, a visual method for performing a root cause analysis, can be used to analyze this issue.  The first step in the Cause Mapping process is to determine how an issue impacts the overall goals and then the Cause Map is built by asking “why” questions to visually lay out the cause-and-effect relationships.  In this example, we’ll focus on the safety goal since it is clearly impacted by 5.5 million cases of norovirus transmitted via food.

So why are people getting norovirus from food?  This is happening because they are consuming contaminated food, predominantly at restaurants or catered events.  The food becomes contaminated when a food worker’s hands are contaminated by norovirus and they touch food, particularly food that is ready to serve and won’t be cooked prior to consumption.  (Disclaimer: You may want to stop reading here if you are eating or thinking about going to out to eat soon.)

For those unfamiliar with the illness, norovirus is basically a gastrointestinal nightmare that can cause the human body to do very messy things.  If a food service worker is ill, the virus can get on their hands, especially after using the bathroom.  According to a Centers for Disease Control and Prevention (CDC) report, the transmission of food-borne norovirus is “primarily via the fecal-oral route.”  And that is more than enough said about that.

It is also worth asking why food workers are at work if they are under the weather.  In the US, few food service workers get paid sick leave so they may show up at work sick because they are concerned about the loss of income and the impact on their jobs.  It’s also important to ensure that workers understand the importance of good hygiene and have access to both water and soap and time to effectively wash their hands.

The final step in the Cause Mapping process is to develop solutions to reduce the risk of the problem recurring.  The solutions to this problem are both simple in concept and difficult to effectively implement.  Ideally, food workers should stay home when they are ill and for at least 48 hours afterwards, but this is much easier said than done for many people.  Food workers should also wash their hands after using the bathroom and before handling any food, but it can be difficult to enforce the policy because employers and managers aren’t (and shouldn’t be) closely monitoring what happens during bathroom breaks.

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

Root Cause

Gamma Camera Collapse Kills Patient

By ThinkReliability Staff

On June 5, 2013, a nuclear medicine scanner was being used for a diagnostic procedure at a New York Veterans Affairs (VA) medical center when the gamma camera collapsed on a patient, causing his death.  This issue can be examined in a Cause Map, or visual root cause analysis, in order to determine both the impact to the organization’s goals as well as the causes of the incident.

In this case, multiple goals were impacted, the first and foremost of which is the death of a patient.  This is an impact to the patient safety goal.  Had the camera collapsed at a different time, it could have also injured an employee, causing an impact to the employee safety goal as well.  The death of a patient due to a medical device that functions other than designed is a “Never Event“, or an event that should never happen in a medical facility.  The scanner collapse on a patient clearly does not meet the goals for patient services.  The property goal is impacted due to potential damage to the scanner. (None of the publicly released reports specified how much damage, if any, was caused to the scanner and camera.)  The scanners of this type from this manufacturer were recalled shortly after this incident, impacting the operations goal and necessitating inspection and/or maintenance activities provided by the manufacturer, an impact to the labor time goal.

Investigation conducted shortly after this patient’s death determined the collapse was caused by loose bolts.  The machines were quickly subject to a Class 1 recall with the FDA.  Sites with the recalled equipment were told to discontinue use until inspections and, if needed, preventive maintenance could be performed by the manufacturer.  Said the manufacturer’s spokesperson, “If no issue is found with the support mechanism fasteners, the site can resume use of the device. If an issue with the support mechanism fasteners is found on a system, the GEHC Field Engineer will coordinate the replacement of impacted parts, and ensure that the system is operating appropriately and meets all specifications.”

Publicly released information about the incident has not specified who was responsible for the preventive maintenance that may have determined the need for tightening the bolts.  However, inspection and maintenance costs were covered by the manufacturer of the devices.

Sites that are using the affected models should have been notified and should stop use until the recommendations of the recall are met.  Although details of broader solutions were not available, both the manufacturer of the devices and the healthcare facilities using them will surely take a look at the preventive maintenance schedule to decrease the risk of patient injury from this type of event.

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

Root Cause

Study Finds Bacteria Can Live on Airplane Surfaces for Days

By Kim Smiley

With many bodies packed into a tight space and seemingly stale air, airplanes tend to bring out the inner germaphobe in many of us.  And the latest research, especially if you just read the headlines, isn’t going to help. Researchers at the University of Auburn found that Methicillin-resistant Staphylococcus aureus (commonly known as MRSA) and E. Coli can live for days on airplane surfaces.

The experiment involved sterilizing six surfaces found on airplanes (seat pocket, arm rest, leather seat, window shade, tray table and toilet handle), introducing MRSA and E. Coli bacteria to them and then measuring how long the bacteria survived.  Typical conditions inside an airplane were stimulated and the bacteria were suspended in three different solutions (saline, simulated seat and simulated saliva) to replicated the environment inside an airplane. The survival times ranged from 8 to 2 days.  This is a little scary, especially since an estimated 1-2 percent of people in the US may be carriers of these dangerous bacteria.

The good news, and there is good news, is that the surfaces where the bacteria lived the longest, the more porous surfaces such as the seat pocket, are the least likely surfaces to actually spread the contamination.  The study also didn’t look into how much bacteria remained after the typical cleaning  by airlines between flights, but the researchers plan to look into this in the future.

So what can you do to reduce the risk of illness if you have plans to travel on an airplane soon?  The simplest thing you can do to protect yourself is to frequently wash your hands with soap or use hand sanitizer as well as avoid touching your face as much as possible.  If you feel the need to take additional precautions, you can clean the areas around your seat with a disinfectant when you board the plane.

Airline cleaning procedures can also significantly impact the spread of illness.  So the question is, how much do you trust the thoroughness of the cleaning performed by the airline?  I think I may invest in a travel-size hand sanitizer before my next flight.

To see a high level Cause Map of this issue, click on “Download PDF” above.

Root Cause

Lethal injection fails to quickly kill prisoner

By ThinkReliability Staff

While the use of the death penalty remains highly controversial, there is general agreement that if it is used, it should be humane.  The execution of a prisoner in Oklahoma on April 29, 2014 did not meet those standards.  The inmate died 43 minutes after the drugs were injected.  (Typically death takes 5-6 minutes after injection.)  According to Jay Carney, the White House Spokesperson, “We have a fundamental standard in this country that even when the death penalty is justified, it must be carried out humanely – and I think everyone would recognize that this case fell short of that standard.”

The details surrounding this case can be captured in a Cause Map, or visual root cause analysis, to examine the causes and effects of the issue.

The problem being evaluated is the botched execution of an inmate in the Oklahoma State Penitentiary. The execution began at 6:23 pm on April 29, 2014.  An important difference in this execution, compared to other executions, is that it was the first time the state had used the drug midazolam as part of the three-drug injection protocol.  The protocol, when originally developed in 1977, called for sodium thiopental, followed by pancuronium bromide and potassium chloride.

The safety goal was impacted in this case because of the failed execution.  The public service goal can be considered to be impacted as the execution was called off (after all three drugs were administered; the prisoner later died of a heart attack.)  The schedule goal is impacted because all future executions have been called off.  The state planned a two-week postponement of the next execution (scheduled for later the same day) in order for a review of this investigation to be completed, but at the time of this writing, that execution has not yet been scheduled.  Executions across the country have been appealed or stayed and none have taken place since April 29th.  The labor/ time goal is also impacted due to the investigation into the execution, which has not yet been published.

These goals were impacted due to the failure of the lethal injection.  The process intended to be used for this lethal injection is detailed on the downloadable PDF.  However, from the start things didn’t go smoothly.  Instead of using two IVs, one in each arm, only one IV was able to be connected, in the patient’s groin.  Because sodium thiopental is no longer available (drug companies will no longer provide it for use in lethal injections), the drug midazolam was used instead.  However, the protocol for using that drug is disputed.  In Florida, five times the amount of midazolam is used.  In Oklahoma, midazolam is used along with hydromorphone.  Because of the debate about lethal injection, most states don’t divulge their suppliers, so the efficacy of the drugs used cannot be verified.  In addition, there is generally at least one doctor present to oversee the executions, but these doctors are not usually identified and may not participate in the actual administration of the drugs because many medical organizations ban doctors from participating on ethical grounds.

At this point, it’s unclear what will happen at future executions.  The investigative report being prepared by the state of Oklahoma may give some suggestions as to how to make lethal injections more humane in the future, or this may tilt the scales towards ending lethal injection, or executions altogether.

To view the Outline, Cause Map, and Process Map, please click “Download PDF” above.

Root Cause

Two Los Angeles area nurses are stabbed the same morning at different hospitals by different attackers

By ThinkReliability Staff

The stabbing of a nurse that took place in a Los Angeles County, California hospital on April 20th, 2014, resulted in the serious injury of a nurse.  The danger of increasing violence and attacks within hospitals was demonstrated by this and an unrelated incident at another Los Angeles County hospital that happened later that same morning.  Both involved stabbings to nurses, though in the first case, the attacker used a knife after he bypassed security and in the second case, the attacker stabbed a nurse with a pencil.

By performing a root cause analysis of just one demonstrative case, solutions that can prevent similar issues (like the one that happened later that very day as well as many other recent cases of hospital violence) can be developed.  We will use Cause Mapping, a visual diagram of cause-and-effect relationships, of this case as an example of hospital violence.

The first step in the Cause Mapping process is to describe the what, when, and where of an incident, and define the impacts to an organization’s goals.  In this case, the employee safety goal is impacted by the serious injury to a nurse.  The patient safety goal is impacted by the potential for injury to a patient.  The patient services goal is impacted by the fact that a violent attacker was able to bypass a weapons screening area.  It’s unclear from the information available whether other goals were impacted in this case.  Once that is determined the “?” can be replaced with the actual impacts to the goals, or “none”.

It can be helpful to determine the frequency of a type of incident.  Clearly, since about seven hours passed between two stabbings of nurses within the same county in California, the frequency of these types of attacks is much too high.

Next, cause-and-effect relationships are determined by beginning with an impacted goal and asking “Why” questions.  In this case, the injury to the nurse was caused by multiple stabbings.  The stabbings resulted from the nurse encountering a violent attacker and were impacted by the response time.  (In this case, security was searching for the man after he bypassed the weapons screening and was alerted to his presence when the attacked nurse began to scream.)   It is unclear how the man was able to bypass the weapons screening station, but ideally improvements that would decrease the possibility of entrants bypassing it in the future will be implemented.

Violence within hospitals has been increasing over recent years, believed to be due to a number of factors.  In addition, nurses and other hospital personnel have noted the difficulty in determining the potential for an escalation of violence in patients and other visitors.  According to the President of the Emergency Nurses Association, Deena Brecher, R.N.,”You need to be able to recognize when things are starting to escalate.  We know our behaviors can help escalate a situation, not intentionally.”

Many nurses are calling for establishment of workplace violence plans that would provide nurses and other hospital workers tools to identify and de-escalate potentially violent behavior, as well as provide additional protections against these types of attacks.  Some hospitals have begun using a mobile distress system, such as a help button worn around the neck that allows a worker to request backup in a situation that feels unsafe.

These solutions bring up an interesting discussion about prevention and blame.  The solutions listed above all require action by the part of nurses or hospital workers.  Many organizations attempt to determine the person to “blame” for a situation, and then assign corrective actions accordingly.  Clearly, nobody is trying to imply that hospital workers are at fault for these violent attacks (blame) but are rather trying to provide tools within their sphere of control to reduce the risk of worker injury (prevention).  Preventing all people prone to violence from entering a hospital, while theoretically more effective at solving the problem, is neither practical nor possible.  Thus it is hoped that providing hospital workers additional tools will result in reduced injuries from hospital violence.

To view the Outline and Cause Map, please click “Download PDF” above.  Or view the Workplace Violence Prevention for Nurses course offered by the Centers for Disease Control and Prevention (CDC).

Root Cause

The Future Is Now?: Building a Neurobridge

By Kim Smiley

A chip was recently inserted into the brain of a man paralyzed from the chest down with the goal of allowing him to move his hand.  The tiny microchip is part of a system, called a Neurobridge, which uses a computer and a sleeve that fits around the patient’s arm in addition to the chip to allow the patient to communicate with his limb by bypassing his damaged spinal cord.  If the procedure works, the patient will be the first paralyzed person who has used his own thoughts to control a limb.  It will be a few weeks before the success of the procedure can be verified, but this is already an exciting development with the promise of amazing future applications of this type of technology.

So how does this Neurobridge work?  An article by The Washington Post “Ohio surgeons hope chip in man’s brain lets him control paralyzed hand with thoughts” by Jim Tankersley discussed the procedure in detail.  The patient’s brain was mapped prior to the surgery using a functional magnetic resonance imaging (MRI) machine.  The patient was shown pictures of hands moving and the areas of his brain that showed activity while he imagined moving his hand were recorded.  Once the surgery began, a portion of the patient’s skull was removed to allow access to his brain.  Electric pulses were fired into the area of the brain believed to control hand movement.  The patient was unable to move his hands, but did have movement of his upper arms so the team watched for a response in his upper arms to verify that the correct location was identified to insert the chip.

Once the chip was inserted into the brain, it was connected by wire to a transmitter port at the skull.  This transmitter port is connected by cable to a computer.  The signal from the brain then travels through the cable into the computer where it is run through an algorithm that mirrors the brainwaves that are present when a person is thinking about moving.  The signal now mimics brainwaves and is sent to a sleeve wrapped around the arm.  The sleeve has tiny electrodes that are used to stimulate the muscles to make the hand move.

It’s an ambitious project that if successful could help not only paralyzed patients, but others with limited motor function like stroke victims.   And as amazing as a Neurobridge sounds, it’s just one of many types of brain implants being actively researched and some of the ideas sound more like science fiction than plain old science.

The Neurobridge process can be illustrated by building a Process Map.  A Process Map visually shows the steps and is generally easier to read than the same information written in paragraph form.  To see a high level Process Map of this procedure, click on “Download” PDF above.

Root Cause

New Federal Rule Limits Level of Coal Dust Allowed

By Kim Smiley

On April 23, 2014, federal officials announced changes to the regulations governing dust-control practices in coal mines.  These changes are the most significant since the Coal Mine Health and Safety Act of 1969 and are intended to curb the increasing number of black lung cases.

Black lung is a potentially deadly disease that occurs when coal dust accumulates in a person’s lungs.  The coal dust slowly destroys parts of the lungs and blood vessels resulting in breathing problems, coughing and even death if the lungs are unable to adequately function.  As discussed in a previous blog, there is evidence that the number of black lung cases has been increasing in recent years.  Many believe that changes to the mining industry, such as modern high-speed mining equipment that produces high levels of dust and longer shifts, are increasing the risks to miners, in at least some mines.

The bad news is that there is no way to remove the dust once it has settled into the lungs and black lung disease is irreversible, but the good news is that it can be prevented by limiting the coal dust a person inhales and this is exactly what the new federal regulations are hoping to do.

The new regulations attempt to reduce the number of black lung cases by reducing the amount of coal dust exposure that is allowed during a shift by 25% (1.5 milligrams per cubic meter from 2.0).  Better monitoring of dust levels will also be required.  Miners regularly exposed to high levels of coal dust will be required to wear monitors that continuously track coal dust levels.  If dust levels are found to be above the limit, immediate actions to lower the dust limits will be required (such as slowing production) and respirators will be required to be available to miners working in the high dust areas.

The changes, first proposed in 2010, have been a long time coming and many in the mining industry have opposed them.  Some plan to continue fighting against the new regulations like Murray Energy Corp who have stated their intention to file a lawsuit against the U.S. Department of Labor saying the new rules are flawed, have no scientific support and are unachievable. As with any new regulation, only time will tell how smoothly the new changes can be implemented and how effective a solution they will be.