Sterilization Matters

May 31, 2013 by · 4 Comments
Filed under: Quality Improvement 

Nina K. ShumanWhen patients undergo surgical or other medical procedures, they hope to receive optimal care provided by experienced physicians. They are rarely concerned about proper sterilization of surgical instruments and other medical equipment as it is likely assumed that the health care facility has applied this standard precaution. Unfortunately, however, not every medical center is adequately sterilizing its equipment, yet this is a crucial element of successful medical care.

According to a report by The Center for Public Integrity, a patient who underwent a routine rotator cuff repair surgery at a Texas hospital in 2009 was readmitted weeks later due to an infection from the deadly bacteria known as P. aeruginosa.[1] An investigation conducted by the Centers for Disease Control and Prevention (CDC) and the hospital revealed that the arthroscopic shaver utilized for the surgery contained the deadly bacteria even after the sterilization process. [2] A more recent incident occurred in March of this year where a routine inspection at an oral surgeon’s office in Tulsa, Oklahoma exposed sterilization issues, including cross-contamination problems.[3] The Department of Health stated, “more than 60 former patients [of the oral surgeon] tested positive for hepatitis and HIV.”[4]

Medical device manufacturers originally sold “single-use” devices because of the demand for disposable equipment.[5] In the late 1970s, hospitals began reusing medical devices intended for or labeled as “single-use” as a cost control measure.[6] The FDA explains that “single-use” devices are to be used once or on one patient during a single procedure whereas reusable medical devices are those that can be reused to treat several patients.[7]

Contaminated reusable medical devises can lead to infections but a method known as “reprocessing” involves meticulous sterilization intended to prevent infections.[8] Reprocessing generally includes the following steps: 1) preliminary decontamination and cleaning in the area of use such as the operating room to inhibit drying of blood and other contaminants on the devises; 2) transfer of the devise to the reprocessing area where careful cleaning occurs and 3) final disinfection or sterilization to allow the devise to be reused.[9] The FDA further explains that problems arise for reprocessing when sterilization instructions by the manufacturer are “unclear, incomplete, difficult to obtain from the manufacturer, or impractical for the clinical environment.” [10] Manufacturer designs that render proper cleaning difficult in addition to scantily paid sterilization technicians are other sources of concern.[11]

There are some diseases that preclude the reuse of medical devices, specifically Creutzfeldt-Jakob Disease (CJD).[12] CJD is a neurodegenerative disorder that causes rapidly advancing dementia, deteriorating memory, drastic changes in behavior, and coordination and visual issues.[13] It is 100% fatal; patients with CJD usually die within one year of disease symptom onset.[14] CJD results when normal brain proteins are transformed into abnormal and infectious forms known as prions.[15] Infected pituitary hormones, dura mater transplants, cornea grafts, and neurosurgical instruments are some examples of materials that can transmit the disease to patients.[16] Most disinfectant and sterilization procedures do not eliminate the infected prions.[17] Importantly, although fatality normally occurs within one year of symptom onset, the disease has an incubation period of up to 50 years, it is not readily detectable until symptoms occur, and is seemingly capable of transmission to others during the incubation period.[18]

The World Health Organization (WHO) released infection control guidelines for health facilities handling patients with CJD.[19] Essentially, any reusable surgical instruments that come into contact with “high infectivity areas” including the brain, spinal cord, and eye should be disposed of and incinerated.[20] But the difficulty, of course, is knowing who is infected with this infectious fatal disease with the disturbingly long incubation period.

Ensuring that hospitals follow proper sterilization is integral, but technician certification is also an important aspect of the overall sterilization scheme.[21] As the director of sterilization at a healthcare facility in New York so accurately stated, “The people who do your nails, they have to take an infection control course before they can apply for a license …Yet the people who deal with lifesaving equipment, they are required to have zero education.”[22] Currently, New Jersey is the only state that makes certification mandatory for sterilization technicians.[23]

As the provision of health care becomes more transparent, patients not only have the ability to choose where to obtain services based on price and reputation of a facility, but they are also, presumably, able to learn about various quality measures. By filtering a search based on location or hospital name, the Centers for Medicare & Medicaid Services’ (CMS) Hospital Compare Website enables patients to view quality measures such as readmission, complication, and mortality rates.[24] There, patients are able to examine the facility’s rates in comparison to the national average.[25] Therefore, improper sterilization leading to increased infection rates will likely be exposed to the public, however attenuated, which could cause patients to seek care elsewhere—at least in time, among consumers able to bring choice to the equation (non-emergency, non-insurance dictated) and who have the ability to comprehend the data. But seemingly, more direct measures can be taken to ensure patient safety.

[2] Id.

[6] Id.

[8] Id.

[9] Id.

[10] Id.

[14] Id.

[20] Id.

[22] Id.

[23] Id.

[25] Id.


Managing Whistleblower Risk and Liability

May 28, 2013 by · Leave a Comment
Filed under: Health Law 

glynn_timothyLast week, the Jersey Journal reported that a jury recently awarded a former employee of Bayonne Medical Center over $2.1 million in his whistleblower suit against the hospital.  The employee, Ceferino Doculan, alleged that the hospital violated New Jersey’s whistleblower statute, the Conscientious Employee Protection Act (CEPA), by terminating his employment as a technician in the hospital’s blood bank because he had complained to hospital personnel that his new supervisor was not qualified to hold that position under New Jersey law.

Although the hospital argued it had terminated Doculan for other reasons, the jury apparently accepted Doculan’s view of the predominant reason for his firing.  According to the article, the jury awarded him about $120,000 in compensatory damages (lost wages and pain and suffering) and $2 million in punitive damages.  The hospital intends to appeal.

The case offers several lessons regarding whistleblower liability risks for hospitals and other healthcare providers.   One broad takeaway is that management of whistleblower risks cannot be disentangled from other compliance matters.   So, in addition to the concerns about how to respond to a whistleblower appropriately, Bayonne Hospital had an actual legal problem – the supervisor was not qualified under New Jersey law.   CEPA and most other whistleblower laws do not limit protection to complaining employees who are correct about the law; typically, the employee’s report must merely be made in good faith.    Yet, intuitively, if the employer has in fact broken the law,  the employee may have an easier time establishing her wrongful termination claim, in part because the existence of the legal violation will potentially make the whistleblower more credible in her lawsuit.  Thus, vigilance about compliance with the law in the employer’s operations in general – in this case, on a human resources-related matter – is a key component in reducing whistleblower liability risks.

Second, keep in mind that, with rare exception, whistleblower laws protect only reports of illegal conduct or conduct that poses some kind of direct and serious risk to the public.  Whistleblower laws do not protect employee reports of violations of employer policies, nonlegal disputes with the employer, or other purely internal matters.   But, in highly regulated industries like healthcare, actions that might not otherwise implicate the law often do.  For example, in most industries, the law does not require a license, special training, or other credentials to serve as a supervisor; in healthcare, things are different.   Compliance personnel in the healthcare context therefore should know that whistleblower liability risks linger in the background of many human resources and other kinds of decisions.  Employee complaints and reports regarding such decisions – even those that might seem standard or run-of-the-mill – therefore should be taken seriously and treated like those that obviously involve legal mandates.

Finally, hospitals and other healthcare providers potentially confront multiple whistleblower regimes.  High-profile whistleblower litigation in this area often involves federal law, most notably, the False Claims Act (including “qui tam” actions for alleged overbilling of the government).  See examples here and here.   And the new whistleblower provisions found in the Affordable Care Act are garnering much attention.  But, as the CEPA claim in this case suggests, many states provide statutory and common-law whistleblower protections that sweep more broadly, potentially protecting employees who report a wide variety of alleged legal violations.   Each of these federal and state regimes has its own set of legal requirements, limitations, and remedies.  A working familiarity with these various regimes can enhance compliance and risk management.

For those interested in learning more about federal and state whistleblower regimes, Seton Hall Law School now offers an eight week online course on managing whistleblower risks.  The course is designed to introduce human resources and compliance personnel to the laws protecting employees who report alleged misconduct of their employers.  If you would like more information, please visit the course website  or call 973-642-8482.


Seton Hall Law & NYLPI Release Report Documenting Hundreds of Cases of Coerced Medical Repatriation by U.S. Hospitals

December 17, 2012 by · Leave a Comment
Filed under: Health Law, Hospitals 

Medical repatriations of undocumented immigrants likely to rise as result of federal funding reductions to safety net hospitals under Affordable Care Act

New York, NY, and Newark, New Jersey, December 17, 2012 –Today, the Center for Social Justice (CSJ) at Seton Hall University School of Law and New York Lawyers for the Public Interest (NYLPI) released a report documenting an alarming number of cases in which U.S. hospitals have forcibly repatriated vulnerable undocumented patients, who are ineligible for public insurance as a result of their immigration status, in an effort to cut costs. This practice is inherently risky and often results in significant deterioration of a patient’s health, or even death. The report asserts that such actions are in violation of basic human rights, in particular the right to due process and the right to life.

According to the report, the U.S. is responsible for this situation by failing to appropriately reform immigration and health care laws and protect those within its borders from human rights abuses. The report argues that medical deportations will likely increase as safety net hospitals, which provide the majority of care to undocumented and un- or underinsured patients, encounter tremendous financial pressure resulting from dramatic funding cutbacks under the Affordable Care Act.

The report cites more than 800 cases of attempted or actual medical deportations across the country in recent years, including: a nineteen-year-old girl who died shortly after being wheeled out of a hospital back entrance typically used for garbage disposal and transferred to Mexico; a car accident victim who died shortly after being left on the tarmac at an airport in Guatemala; and a young man with catastrophic brain injury who remains bed-ridden and suffering from constant seizures after being forcibly deported to his elderly mother’s hilltop home in Guatemala.

According to Lori A. Nessel, a Professor at Seton Hall University School of Law and Director of the School’s Center for Social Justice, “When immigrants are in need of ongoing medical care, they find themselves at the crossroads of two systems that are in dire need of reform—health care and immigration law. Aside from emergency care, hospitals are not reimbursed by the government for providing ongoing treatment for uninsured immigrant patients. Therefore, many hospitals are engaging in de facto deportations of immigrant patients without any governmental oversight or accountability. This type of situation is ripe for abuse.”

“Any efforts at comprehensive immigration reform must take into account the reality that there are millions of immigrants with long-standing ties to this country who are not eligible for health insurance. Because health reform has excluded these immigrants from its reach, they remain uninsured and at a heightened risk of medical deportation,” added Shena Elrington, Director of the Health Justice Program at NYLPI. “Absent legislative or regulatory change, the number of forced or coerced medical repatriations is likely to grow as hospitals face mounting financial pressures and reduced Charity Care and federal contributions.”

Rachel Lopez, an Assistant Clinical Professor with CSJ stated, “The U.S. is bound to protect immigrants’ rights to due process under both international law and the U.S. Constitution. Hospitals are becoming immigration agents and taking matters into their own hands. It is incumbent on the government to stop the disturbing practice of medical deportation and to ensure that all persons within the country are treated with basic dignity.”

More information about this issue can be found at, a NYLPI- and CSJ-run website that monitors news and advocacy developments on the topic of medical deportation.

About New York Lawyers for the Public Interest

New York Lawyers for the Public Interest (NYLPI) advances equality and civil rights, with a focus on health justice, disability rights and environmental justice, through the power of community lawyering and partnerships with the private bar. Through community lawyering, NYLPI puts its legal, policy and community organizing expertise at the service of New York City communities and individuals.

About the Center for Social Justice at Seton Hall University School of Law

The Center for Social Justice (CSJ) is one of the nation’s strongest pro bono and clinical programs, empowering students to gain critical, hands-on experience by providing pro bono legal services for economically disadvantaged residents in the region. The cases on which students work span the range from the local to global. Providing educational equity for urban students, litigating on behalf of the victims of real estate fraud, protecting the human rights of immigrants, and obtaining asylum for those fleeing persecution are just some of the issues that CSJ faculty and students team up to address.


Anti-Fraud Efforts Intensify, Broaden

August 14, 2012 by · Leave a Comment
Filed under: Fraud & Abuse 

Health Law, anti-fraudOver the last few weeks, the fight against healthcare fraud has prominently been in the headlines.

First, late last month the Obama administration announced a joint effort between the federal government and major health insurance companies to fight fraud.  According to the New York Times, under the partnership – called the National Fraud Prevention Partnership – the federal government and health insurance companies will share data, trends, and tools to find “upcoders” and other fraudulent billers.  As the article indicates, it is a partnership that makes much sense from the federal government’s perspective as the financial strain on the federal healthcare programs grows ever-tighter, and the return-on-invest for the governments’ fraud investigations is somewhere between $7-to-$1 and $15-to-$1 – no matter the actual number, a good investment for Uncle Sam.

Second, just last week, the New York Times reported that Hospital Corporation of America (“HCA”) Healthcare, the major for-profit hospital chain that owns 163 hospitals across the country and a party that has been no stranger to fraud settlements in the past, is under investigation for unnecessary cardiac procedures at its hospitals that sometimes resulted in clear patient harm.

With anti-fraud tools built in to the Affordable Care Act, an increase in funding to fight healthcare fraud throughout the country, and intensified focus, expect the anti-fraud efforts of the federal agencies to not only continue, but intensify.  Those providers who offer clearly unnecessary procedures will have very little defense.  Indeed, in addition to overbilling the federal-government and private insurance payors, causing the costs of healthcare for us all to increase, these providers are harming patients by subjecting them to more (and often dangerous) care – which sometimes results in life-threatening harm for no reason.

However, with these increased resources, the challenge of differentiating which cases reflect clear, intentional, and fraudulent overtreatment from the investigations that reflect poor or inefficient decision-making by the provider will be formidable.  And with the blunt, unforgiving False Claims Act in the back pocket of the federal government’s investigators, providers should take extra caution when trying to decide whether or not to order that extra test or procedure.


Exiling the Poor from the Insurance Market

July 22, 2012 by · 1 Comment
Filed under: Hospitals, Medicaid, Medicare 

pasquale_frank_lg1John Roberts’ jurisprudential wizardry in NFIB has been compared with the artistic genius of pro wrestlers and rappers. Poor Americans in states newly empowered to resist the ACA’s Medicaid expansion may need even more ingenuity to get themselves insured. Both Kevin Outterson and my colleague John Jacobi have observed the perplexing predicament imposed on the poor in states that keep Medicaid 1.0, and resist Medicaid 2.0. From Jacobi’s post:

The reform provides insurance subsidies through tax credits. The credits are calculated on a sliding scale, according to household level, for people with income up to 400% of FPL [the federal poverty line] — subsidizing more generously someone earning 200% of FPL, for example, than someone earning 350% of FPL. But, under 26 USC 36B(c)(1), credits will not be distributed to those with incomes below 100% of the FPL. Why? Because Congress assumed states would take up the Medicaid expansion, obviating the need for exchange-based subsidies for the very poor. . . .Bottom line: states rejecting Medicaid 2.0 will not only forego about 93% federal funding for the program between 2014 and 2022, but they could also be depriving the poorest of the uninsured from any shot at coverage — potentially affecting millions nation-wide.

Georgia hospitals are already worried about the “unexpected prospect of lower reimbursements without the expanded pool of patients” to be covered by the Medicaid expansion:

Last year, Georgia hospitals lost an estimated $1.5 billion caring for people without insurance. The promise of fewer uninsured is what led the national hospital industry to agree to the health law’s $155 billion in Medicare and Medicaid cuts over a 10 year period. The Medicaid curveball comes at a time when Georgia hospitals are already in the throes of a massive industry transformation to improve quality and efficiency driven by market forces as well as the new law. Hospitals face lower payments from insurers and pressures to consolidate. One in three Georgia hospitals lose money. All are busy preparing for new standards under the law that, if not met, could mean millions of dollars in penalties.

It’s hard to imagine how hospitals like Grady can continue to act as a safety net in that environment. The article notes that “Georgians already pay for the cost of care provided to people without insurance through higher hospital bills and inflated insurance premiums.” If that trend continues, all the states refusing Medicaid 2.0 may end up doing is shifting the cost of the Medicaid expansion population from national taxpayers to Georgians with insurance. The superwealthy Americans of Marin County and Manhattan ought to send Georgia Governor Nathan Deal a thank you note for keeping Georgians’ problems for Georgians themselves to solve.


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