Severe Medical Errors Penalties Proving Ineffective – Evidence Shows

 

Medical Malpractice

We are playing devil’s advocate here in lieu of our last post.  We posted to cause some discussion.  Please enjoy.

In medical circles, preventable errors sometimes occur. These errors range from minor mistakes like leaving a patient lying in one position for too long; to more serious ones like performing a surgery on the wrong part of the body. The outcomes of such errors can range from patient discomfort to debilitating injury or even death.

In a bid to reduce medical errors (especially the ones which cause severe injuries or death), both federal and state agencies impose a number of penalties on hospitals. Medicare, for instance, does not pay for treatments linked to medical errors. Almost all states impose fines on hospitals which don’t report the incidences of severe medical errors.

The state of California is especially severe in its penalties. First of all, hospitals face penalties of up to $125,000 per incident of medical error. Secondly, the state has a mechanism for shaming errant hospitals. It does this by publishing the names of hospitals, as well as details of medical errors in publicly accessible news outlets, blogs and social media.

Compared to other states, California’s penalties seem rather draconian. This is because the penalties can be imposed irrespective of whether or not the incident was voluntarily reported. However, the real sticking point is about the effectiveness of such measures. In other words, are the severe penalties imposed on hospitals leading to an overall reduction in the rate or severity of preventable medical errors?

According to an analysis of California state data carried out by the San Diego Union-Tribune, the answer is no. The state’s severe penalties haven’t contributed towards any noticeable reduction in the incidences of preventable medical errors. At least there isn’t any significant reduction when a comparison is made with states whose penalties aren’t as severe.

Since 2007, California has fined hospitals a total of $17 million for preventable medical errors. The state has also publicly shamed a total of 192 hospitals for a range of errors such as leaving surgical sponges inside patients, performing surgeries on wrong parts of the body and giving patients fatal doses of medication.

These punishments haven’t led to overall reduction in the frequency of such errors. For instance, the incidences of foreign bodies left inside patients bodies is currently higher than its pre-2007 levels. In fact, as of March 2016, the combined number of all medical errors was higher than the numbers in 2006 – before the state introduced its penalties and shaming program.

Basically, nine years of severe financial penalties and public shaming have done nothing to reduce the incidences of medical errors. In fact, imposing the punishments on specific hospitals hasn’t led to a remarkable drop in the medical errors within those hospitals.

There have been cases of some hospitals being penalized on numerous occasions. The most poignant example is the UC San Francisco Medical center which has been fined 9 times. Another example is the Southwest Healthcare System which has two hospitals in Murrieta and Widlomar which have been penalized a total of 13 times. In each of these cases, the fines have ranged from $75,000 to $125,000.

If the penalties were effective, they would have led to reductions in medical errors – if not generally, then at least in specific hospitals which have been penalized. However, if a hospital can be fined 9 or 13 times over a nine-year period, then it is obvious that any systemic changes which the fines are intended to bring actually isn’t happening.

Most medical experts think that the severe penalties could actually be discouraging hospitals from reporting incidences of medical errors. After all, if even voluntarily reporting the incidences still leads penalties, then what motivation do hospitals have to actually report them?

Basically, the penalties could be creating an atmosphere which makes it less likely for medical staff to voluntarily report incidences of medical errors. And yet, in order to reduce the errors, it is essential to create a culture in which medical personnel can easily come forth and report them.

The evidence that California’s hospitals could be underreporting incidences of medical errors is found in the state’s statistics. For instance, in the 2015 fiscal year, the state reported a total of 1,283 deaths from medical errors. Some experts find this extremely low, when compared to the numbers from national studies.

Their argument goes as follows. According to data from national studies, between 200,000 and 400,000 people die annually as a result of medical errors. Given that the state of California has almost 10% of the nation’s population, it wouldn’t be a stretch to expect it to contain 10% of the fatalities. This means that the total number of medical error fatalities should be between 20,000 and 40,000 annually. This basically means that the 1,283 reported is an extremely small fraction of the actual numbers.

There are those who argue that the steep financial penalties could be depriving hospitals of the resources they could have used to improve their operations. Instead of fining a hospital $100,000, it would be more effective to tell the hospitals to use the money to make improvements which are directly related to the medical error. Otherwise, the fines will only benefit the health departments to which they are paid.

Using financial penalties in an attempt to reduce medical errors actually trivializes the problem. The simple fact is that minimizing medical errors is quite complex. This is because the possible root causes of the errors can be varied. Even for a specific category of errors (e.g. performing wrongful surgical procedures) the actual causes can vary from one hospital to work. As such, using a one-size-fits-approach is unlikely to be effective.

After all, there are specific types of medical errors which have reduced over time – even without the use of extreme penalties. For instance, the incidences of blood infections arising from catheters dropped by 50% between 2008 and 2014, according to the CDC. These blood infections used to arise from a common error – leaving central line catheters (which are used to deliver medicines) – for too long. A concerted effort of education and training – without any extreme penalties – is what brought about the reduction in the error.

The bottom line is that medical errors can be reduced without resorting to draconian penalties. This is not to suggest that hospitals should never be sanctioned over actions which endanger patient safety. The point is that the sanctions shouldn’t discourage hospitals from reporting incidences, or deprive them of the very resources they need to reduce such incidences. Otherwise, medical errors penalties of the kind found in California could actually be exacerbating – rather than minimizing – the problem of medical errors.

Severe Sanctions Need To Be Instituted For Errant Nurses

 

medical sanctions bad nurse

Patient welfare is perhaps a nurse’s primary and most critical responsibility. Every nurse intuitively knows this. As such, during the course of their duties, most nurses do their utmost to uphold, protect and enhance patient welfare.

Unfortunately, the heroic efforts of good nurses are sometimes undone by a few bad apples. These are nurses who aren’t particularly bothered about patient comfort, wellbeing or safety. Such nurses are typically sloppy, unprofessional or downright criminal. Their conduct often doesn’t just jeopardize the patient welfare, it also hurts the reputation of the nursing profession.

A case in point Randall Silsby – a nurse with a New York nursing license. In 2012, Silsby is said to have sexually assaulted an 85-year old patient at the Wilson Medical Center in Johnson City, New York. Apparently, Silsby fondled the breasts of the woman who at that point was under sedation.

The strangest fact is that when state officials investigated the incident, they didn’t punish Silsby for it. Instead, they punished him for an offense which they should have discovered a decade earlier when Silsby re-applied for his nursing license in 2002.

Now, Randall Silsby had actually first received a New York nursing license in 1992. However, five years after receiving his license, he decided to “die”. Basically, he traveled to the Dominican Republic and connived with a lawyer to draft for him a death certificate. He did this because he was overwhelmed by child support payments from two previous divorces.

When Silsby decided to resurrect and return to the US in 2001, he was charged with a felony, and jailed for 6 months. In 2002, upon release, he decided to reapply for his nursing license. The New York Office of Professions did not conduct a background check on Mr. Silsby. As such, it renewed his license without a hustle.

In 2012, when investigations were opened into the sexual assault allegations, that is when Mr. Silsby’s previous infractions were discovered. He was thus given a one-month suspension for faking his death. However, no further action was carried out about the more serious allegation of sexually assaulting a patient.

Laxity In Oversight

The story of Randall Silsby perfectly illustrates one of the greatest threats to the healthcare industry today – a laxity of nursing oversight. Despite the existence of clear-cut nursing standards, and well-known medical sanctions, holding errant nurses accountable is still being carried out haphazardly.

Granted, the level of oversight varies from state to state. While some states like Ohio, Texas, and California are relatively vigilant in carrying out disciplinary action against errant nurses, others like New York are quite lax. For instance, in 2014, New York disciplined an average of 1 in 1,190 licensed nurses. This is extremely low compared to the 1 in 153 and 1 in 167 licensed nurses disciplined in Ohio and Texas respectively.

The laxity in oversight takes three forms (1) failing to subject applicants for nursing licenses to comprehensive background checks (2) failing to adequately investigate incidences of misconduct, and (3) failing or delaying to sanction errant nurses. Let’s examine each of these scenarios more closely.

Background Checks

As clearly illustrated in the story of Silsby, some states issue licenses to nurses without subjecting them to thorough background checks. For instance, in New York, nurses applying for licenses are not required to undergo simple background checks or fingerprinting. The end result is that people who should never have been licensed are let into the nursing profession.

A case in point is Celeste Nwana, a nurse whose license was withdrawn in New Jersey in February 2013 for improperly drugging a patient and landing them into the emergency room. Celeste, who had earlier been sanctioned for forging patient medical records, faced criminal charges for drugging the patient.

Two years later, Celeste decided to apply for a nursing license in Connecticut and New York. In Connecticut, the license was denied because a background check revealed that she had lied about her criminal record in the application. In New York, the license was approved and is still active.

Inadequate Investigations

In cases of alleged misconduct by nurses, the investigation process is often flawed. In some cases, as in Silsby’s case, the investigations aren’t conducted out at all. In other cases, the investigation process is extremely slow, deeply flawed or inadequately carried out.

A case in point is Danielle DiScuillo a New York registered nurse who was charged with DUI in 2010. When she applied to renew her license in 2013, she voluntarily revealed the DUI charge. She was given the license. However, months later, she received a letter informing her that she was under investigation.

It took 9 months from the time Danielle DiScuillo volunteered her DUI for her to be summoned for a hearing. It took another five months for her to be given a one-month suspension. In the end, it took a total of 1 year and 3 months to investigate a simple DUI charge.

DiScuillo’s case is a perfectly illustrates how slow the investigative process can be. In some instances, allegations of misconduct take years to investigate. The process becomes stressful for all the parties involved. DiScuillo’s words about the process summarize the feeling: “It was torture at times; I just wanted to know what was going to happen”, she said, in an interview with ProPublica. (Source: https://www.propublica.org/article/weak-oversight-lets-dangerous-nurses-work-in-new-york)

Delayed or Mild Sanctions

Even where nurses have been found culpable of wrong doing, medical sanctions aren’t carried out swiftly and proportionately. In most cases, the time lag between the moment a nurse is found to have done wrong, and the moment they are sanctioned is unnecessarily long. And when they are finally sanctioned, the punishment isn’t severe enough.

A case in point is Heather Graham, a nurse who was arrested in June 2013 for the theft of 31 vials of hydromorphone from a hospital in Watertown, N.Y. Hydromorphone is an opioid pain medication. Having stolen the medication, Graham made false entries in the dispensing system in an attempt to cover her tracks.

In August 2013, while investigations were underway, New York received a notification that Graham’s license had been revoked in Pennsylvania. The license was revoked because, in March 2012, Graham had been investigated by nursing board in Pennsylvania, and found to be suffering from opiate dependence.

In 2014, a New York court found Graham guilty of stealing medications and falsifying business records. She was sentenced to three years’ probation. Even then, the Office of the Professions did not take any action on Graham’s license until September 2015 – more than one year after her conviction. When it finally did, it simply fined Graham $500 but did not even suspend her license.

A Need For Stricter Oversight

The laxity in oversight is placing patients at risk. This is because it is exposing them to nurses who are unethical, unprofessional or even potential criminals. The end result is that the welfare and safety of patients is being compromised.

Besides patients, failing to sanction errant nurses also has a negative impact on their fellow nurses. When nurses see their colleagues behaving unethically and getting away with it, they stop their doing their utmost to play by the rules. Others can even be tempted to adopt the unethical behavior.

Even those who remain steadfast become resentful towards authority. This is because they see their good work being undone by their unethical colleagues. To make things worse, they see the relevant authorities doing nothing to remedy the situation. This kills their morale.

Ultimately, the weak oversight threatens to undermine the overall quality of the nursing profession. In the end, it is patients who will suffer. Therefore, all agencies charged with oversight over nurses need to up their game. They need to begin imposing medical sanctions on errant nurses swiftly and severely.

Study Reveals Staffing Benchmarks And Trends For Regulatory Affairs Groups Within The Medical Device Industry

Companies within the medical device industry often have to work under a strict regulatory environment. This environment arises from the plethora of local, national and global regulations which govern the development and marketing of medical device products.

To ensure regulatory compliance, most companies put together Regulatory Affairs groups. These groups are charged with two major tasks. The first is paying attention to the various regulations that govern the medical device industry. The second is creating internal policies and practices which can enable a company to comply with the relevant regulations.

A study recently released by Best Practices LLC – a research and consulting firm – revealed the latest staffing benchmarks and trends for Regulatory Affairs groups in medical device companies. The study findings were released in a 91-page report entitled “Regulatory Affairs Excellence: Staffing & Performance in Medical Device Companies.”

The study was carried out with two major goals in mind. The first was to establish metrics and insights regarding staffing benchmarks like the structure, activities, roles and responsibilities of Regulatory Affairs groups. The second goal was to identify key staffing trends in the medical device industry. The trends considered included off-shoring and outsourcing.

To achieve its objectives, the study profiled eight (8) categories of industries involved either directly or indirectly in the manufacture and marketing of medical device products. These industries profiled included Medical Device, Technology, Health Care, Pharmaceutical, Orthopedics, Chemical and Consumer Products.

From each of the industries, a company was selected to be profiled. As such, a total of 8 companies were selected. These include Bausch & Lomb, Johnson & Johnson, Roche Diagnostics, Ethicon, Edwards Lifesciences, DB, Zimmer, Medtronic and Boston Scientific.

In each of the companies, top executives at the helm of Regulatory Affairs Groups were selected to participate in the study. These executives underwent both quantitative interviews and in-depth qualitative interviews.

The interviews centered around key benchmarks which are critical for regulatory affairs. These include: organisational structure, span of control, staffing allocations, regulatory submissions, regulatory affairs roles &leadership; and off-shoring/outsourcing.

The insights from the executives were collected, analyzed and compiled into the study report mentioned above. The key findings of the study can be summarized into three major categories.

The first deals with the current status of Corporate Regulatory Affairs Groups (CRAGs) in the medical device industry. In this respect, the study found that these groups average seven FTEs. Their major roles include promoting standards, monitoring the global regulatory environment, coordinating policy advocacy efforts both internally and externally; and advising Regulatory Affairs staff.

The second category of findings deals with the roles and responsibilities of Regulatory Affairs staff. Their roles include handling regulatory submissions, conducting quality audits, handling FDA listings/registrations, handling complaints, responding to FDA 483 observations, and dealing with other regulatory agencies.

The final category considers the future trends in regulatory affairs staffing. The study projects that within the next three years, there will be a growth in the regulatory affairs function using a combination of internal and external resources. The external resources will include off-shoring and outsourcing. However, the levels of off-shoring and outsourcing are unlikely to increase beyond the current industry levels.

The study results can benefit companies which are operating within the medical service industry. It can provide their regulatory affairs groups with evidence-based insights and benchmarks for staffing, budgeting and other regulatory activities. Such insights are currently unavailable in contemporary journal articles and market research databases.

The results can also help regulatory affairs executives and leaders to gage their organization’s performance. They can do so by comparing their companies to the medical device organisations featured on the study. This can provide an effective benchmark for evaluating regulatory function within organisations.

In order to fully benefit from the study findings, medical service companies need to access the full findings of the report. A summary of the findings – as well as a copy of the full report – can be viewed by visiting the Best Practices LLC website. (http://www3.best-in-class.com/rr1385.htm)

What Is The Exclusion Statute?

The Exclusion Statue is a section of the Social Security Act (SSA) which spells out circumstances which certain individuals or entities can be banned from participating in Medicare and other federal healthcare programs.

It is what the Office of the Inspector General (OIG) uses to exclude individuals or companies from programs like Medicare and Medicaid. The statute is found in sections 1128 and 1156 of the SSA.

Excluded individuals and entities are banned from participating in healthcare programs either directly or indirectly. Any organisation which administers Medicare or Medicaid is banned from hiring or contracting excluded individuals or entities.

The Exclusion Statute spells out two types of exclusion i.e. Mandatory Exclusions, and Permissive Exclusions. Here is a brief look at each of these types of exclusions

Mandatory Exclusions

Mandatory exclusions are supposed to be enforced by the OIG. They are legally required for individuals or entities who commit certain violations. The violations which can lead to mandatory exclusion include:

  • Patient abuse and neglect

This is where an individual or entity is convicted for abusing or neglecting patients under their care.

  • Healthcare fraud

This is where an individual or entity gets a felony conviction for fraud, theft, embezzlement, breach of fiduciary responsibility or any other financial misconduct. The convictions are supposed to be for crimes committed during healthcare service provision.

  • Controlled substances

This is where an individual or entity gets a felony conviction for illegally manufacturing, distributing, prescribing or dispensing a controlled substance.

  • Program related crimes

This is where an individual or entity gets convicted for committing crimes related to healthcare programs such as Medicare and Medicaid.

As soon as an individual or entity is proven to have committed violations spelled out under Mandatory Exclusions, they are supposed to be excluded from federal healthcare programs.

Permissive Exclusions

Permissive Exclusions are left to the discretion of the OIG. Although the Exclusion Statute suggests scenarios under which permissive exclusions may be invoked, the ultimate decision is left with the OIG.

The situations under which an individual or entity can be subjected to permissive exclusions include:

  • Conviction for fraud
  • Conviction for obstructing an audit or investigation
  • Conviction for committing a controlled substance-related misdemeanor
  • Suspension of License i.e. if an individual or entity has their license suspended by a State, Federal or regulatory authority
  • Ownership of a sanctioned entity
  • Default on educational loan and scholarship obligations.

Those are just a few of the grounds under which the OIG can subject an individual or entity to a permissive exclusion. The full list of grounds can be viewed on this Exclusion Statute web page (https://www.law.cornell.edu/uscode/text/42/1320a-7).

Other Provisions under the Exclusion Statute

Besides spelling out the two types of exclusions, the Exclusion Statute also outlines the following:

  • The steps which are taken before an individual or entity becomes excluded
  • The length of time under which the exclusion can last
  • The process by which an individual or entity can have their exclusion terminated
  • A definition of different terms used in the statute

In a nutshell, the Exclusion Statute is the law which is used by the OIG to impose healthcare sanctions on individuals or entities. The above is a summary of the major contents of the statute. To read the entire statute, visit University of Cornell’s Legal Information Institute webpage, https://www.law.cornell.edu/uscode/text/42/1320a-7.

What Is The Medical Whistle Blower Law?

When a medical practitioner notices unethical, unsafe or potentially unlawful practices at their workplace, they are bound by medical ethics to do something about it. In most cases, they are mandated to raise the matter internally, and if things fail, then report to regulatory authorities.

However, there are cases where a medical practitioner is empowered to take legal action on behalf of the government. This is specifically when the practitioner notices fraudulent acts being committed against the government. They are empowered to take legal action under the medical whistle blower law.

The medical whistleblower law is actually a section under the False Claims Act. Also known as the Qui Tam provision, this section empowers individuals to take legal action against entities which are involved in defrauding the government.

The fraud covered by the law usually takes one of three forms: falsely billing the government, overcharging the government for services or supplies, and under-valuing obligations which are paid to the government.

In the healthcare field, such frauds are commonly committed by drugs manufacturer/suppliers, providers of services to Medicare or Medicaid patients, and other holders of federal government contracts.

The medical whistle blower law empowers individuals to take legal action against those who commit such frauds on behalf of the government. It spells out the process through which an individual can take such action, as well as benefits and protections which can accrue to them.

A Basic Whistle Blower’s Process

A whistleblower can file a lawsuit in any US District Court against any person or organisation it suspects of defrauding the government. When the suit is filed, the whistleblower isn’t the plaintiff. Rather, it is the government which is the plaintiff. The whistleblower is referred to as a “relator”.

Any lawsuit brought by a relator is filed “under seal”. This means that the only parties who know about it are the relator and the government. The reason why it is filed under seal is to protect the identity of the relator.

After the suit has been filed, the Department of Justice (DOJ) is supposed to investigate the claim within 60 days. Such an investigation is usually carried out in conjunction with District Attorney of the jurisdiction in which the case was filed.

The goal of the investigation is for the DOJ to determine whether the matter is worth pursuing. If they judge the matter worth pursuing, then they go ahead and begin legal proceedings against the defendant.

In case the DOJ wins the case, then the relator is entitled to between 15% and 25% of any finances recovered from the defendant. Financial recovery is almost always guaranteed for any case won, since restitution is part and parcel of fraud cases.

In case the DOJ decides not to pursue the matter, the relator is empowered initiate legal proceedings on their own. If they win the case, then they are entitled to up to 30% of the monies recovered from penalties levied on the defendant.

Protection Against Retaliation

It is common for whistleblowers to face retaliation for exposing fraudulent (or any other unlawful) acts. This is true especially if the whistleblowers are employees in the organisation against which they have blown the whistle. The medical whistleblower law offers protection against retaliation in two ways.

First of all, it hides the identity of the whistleblower. This is why the lawsuits are filed under seal. This is also why the DOJ investigates the claims before bringing charges against the defendant. It is also why it is the government, rather than the whistleblower which is the plaintiff. All these contribute towards protecting the identity of the whistleblower.

Secondly, in case a whistleblower is indentified, the law makes it illegal for employers to carry out retaliatory actions against them. Such retaliations are almost inevitable if the defendant is the whistleblower’s employee. They typically include threats, demotions, withdrawal of privileges and even termination of employment.

Any employer who takes retaliatory action against a whistleblower can be sued. In case they are found guilty, they can face a number of punitive sanctions. The bottom line is that the law protects whistleblowers against blowbacks and retaliations.

Famous Cases Brought Under The Law

The most famous (or is it infamous) lawsuit brought under the medical whistleblower law is the one which led to the $2.3 billion settlement by Pfizer in 2009. The suit which was initiated by a whistleblower alleged that the drug giant was marketing to Medicare and Medicaid patients drugs which weren’t covered by the federal healthcare programs. Pfizer agreed to pay the settlement, and the whistleblowers earned $104 million for their efforts. Click to read more.

Another famous case involved the drug giant GlaxoSmithKline (GSK). This suit was brought by a former employee who alleged that GSK was selling substandard drugs. The whistleblower claimed to have raised the matter internally, but instead of resolving it, she was fired. She initiated a lawsuit under the medical whistle blower law, which culminated in GSK being slapped with penalties totaling $750 million. The whistleblower was given $96 million. Click here to read more.

It isn’t just medical workers who have brought cases under this law. In 2003, Richard West, a 56 year-old patient brought a lawsuit against Maxim Healthcare – a leading provider of healthcare services. Mr. West had noticed that Maxim had billed the Medicaid for 735 hours of nursing care he’d never received.

Having reported the matter to New Jersey officials, a social worker and even Medicaid without anything getting done, West brought a lawsuit against Maxim. Thanks to Maxim’s financial muscle, the case dragged for seven years, before being resolved in 2011. Maxim was fined $150 million, and Richard West received 14.8 million. Click here to read more.

In Summary

The medical whistle blower law empowers individuals to initiate legal proceedings against healthcare provides who defraud the government. It offers whistleblowers protection against retaliatory actions. In case the cases lead to financial settlements, it entitles whistleblowers to a proportion of the settlements.

Therefore, in case you notice any medical fraud being committed against the government, then it is your duty to do something about it. If you are an employee, your first course of action may be attempting to resolve the matter internally. If you are a patient, then your first course of action may be contacting the authorities in your area.

Incase these options fail, then you can begin legal proceedings under the medical whistle blower law. You will not only make the country a better place, you may earn some money for your efforts.