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.

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Adventures in Health Care Cost Cutting

March 17, 2013 by · Leave a Comment
Filed under: Health Reform, Medicaid 

pasquale_frank_lg11

Expect to keep hearing more talk about health care cost cutting, despite charts like this. It’s an idee fixe of the Wall Street/Washington corridor, and will only be implemented more vigorously over time.  So perhaps we should take stock of a few cost cutting initiatives. Medicare Part D, it seems, is coming way under its projected budget.  But maybe that’s because of “a sharp fall in the number of breakthrough drugs,” a sign that innovation in pharma is stalling.  Cost cutting triumph, or logical outgrowth of a system that fails to reward actual contributions to health?

There’s also been a lot of pressure on skilled nursing facilities to hold the line on costs.  What are we getting in return? Here’s a summary from OIG:

Skilled nursing facilities (SNF) are required to develop a care plan for each beneficiary and provide services in accordance with the care plan, as well as to plan for each beneficiary’s discharge. . . For 37 percent of stays, SNFs did not develop care plans that met requirements or did not provide services in accordance with care plans. For 31 percent of stays, SNFs did not meet discharge planning requirements. . . . [R]eviewers found examples of poor quality care related to wound care, medication management, and therapy. These findings raise concerns about what Medicare is paying for. They also demonstrate that SNF oversight needs to be strengthened to ensure that SNFs perform appropriate care planning and discharge planning.

I’m sure the health care cost cutters will use this evidence to demand the SNFs be paid even less–rather than, say, investing real funding in proper training and pay in this vital service sector.  At some point, though, costs get cut so much that Medicaid will become little more than a meaningless plastic card, and “SNF” will stand for “Scarce Nursing Forever.”

This post first appeared on HealthLawProf Blog.
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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 medicalrepatriation.wordpress.com, 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.

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Health Care Professional Ratings Tied to Efficiency

December 6, 2012 by · Leave a Comment
Filed under: Uncategorized 

The degree of effort put into selecting health care professionals varies among consumers.  For instance, many relatively young users of health care may only go through the motions of selecting a primary care physician, whom they may seldom visit, and never investigate specialists that provide more particularized care.  A recurring question, however, amongst more frequent health care consumers is “who provides the best care?”  As consumers become older, mature, develop ailments more frequently, and raise families, this question becomes asked more and more frequently.  Where is such a consumer to look for reliable information?  Yes, rating systems of health care professionals are available.  But the objectivity of such systems is often questioned because of the agenda of those developing the rating systems.  For instance, Andrew Cuomo, the former New York Attorney General, injected New York State into the practices through which an insurance company rated the health care providers in its network.  The concern identified by the Attorney General’s office was that insurance companies would rate health care providers based upon their ability to provide care cheaply, rather than on their ability to provide quality care.  This concern stemmed from the undeniable profit self-interest of the insurance company. However, was such a stance by the now Governor necessary or appropriate?  I think not.

Determining the quality of care delivered by a health care provider is an inherently subjective task.  The outcomes of individual patients will depend upon a multitude of factors, many of which are out of the control of the provider.  Different patients will react differently to different treatments because of their unique physiology.  The same ailment will have indiscernibly progressed to varying degrees in different patients.  A doctor could follow all the proper protocols, provide the care called for (i.e., satisfy the standard of care), yet a poor outcome could nonetheless result. The outcome in these instances is largely the result of the “luck of the draw” with respect to a patient pool.  Thus, trying to determine which doctors provide the best care is inevitably a limited, if not fruitless, endeavor.

Additionally, a mechanism is already in place to ensure that substandard doctors are not practicing.  The training to become a doctor and the required certifications to practice serves as the screening mechanism to ensure that health care providers have the requisite skill to perform their trade.  So long as doctors are meeting this minimum established by their field, patients should be led to believe in the ability of those doctors to provide adequate care.  Ranking doctors based on outcomes naturally leads consumers to believe that entry level standards are watered down such that doctors “at the bottom” are not competent to perform; which is simply not the case.

Finally, ranking doctors based upon efficiency or cost factors serves a valid societal purpose.  Firstly, putting utility aside, such metrics are readily quantifiable, accurate, and objective.  And with respect to utility, many patients want efficiency.  An efficient doctor is, it would seem, much less likely to engage in “defensive medicine.”  For a time pressed patient, as many of us are, reassurance that our time will not be wasted with unnecessary tests and precautions holds real value.  And on a societal level, it is obvious that health care costs are out of control.  I have recently been put in a position where I must acquire a policy for my family on the open market (I am leaving a secure government position with subsidized health benefits for a position as a law clerk with a small law firm, which does not extend health benefits to its clerks). My monthly contribution is currently $330 for a health plan with no deductible and $20 co-pays.  It appears as though my best option on the open market is a $1200/month plan, with a $1,000 deductible.  My family is young and healthy. Our annual doctor visits consist of well visits, totaling approximately $1,000 in total costs. With this in mind, if insurance companies can encourage the use of efficient providers (who have been vetted by their profession as proficient at what they do), then this practice should be encouraged.  A “high efficiency” network at a reasonable cost would certainly perform well on the open market, particularly among us consumers that don’t actually anticipate using their policies.  Health care is or will be a significant factor in everyone’s life at some point.   However, if we can prevent it from becoming the driving financial concern among the middle class, that would appear to be a worthy cause.

Adam Peterson is a third-year evening student at Seton Hall University School of Law. He received his B.S. in Conservation Biology from the State University of New York College at Cortland in 2007. Since that time he has worked for the New York State Department of Environmental Conservation as an Environmental Analyst, reviewing development projects for compliance with New York State environmental regulations.

Image by Ludraman.

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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.

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