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.


Online Health Law Graduate Certificate Programs

May 8, 2013 by · Leave a Comment
Filed under: Health Law 

Online Learning e-Mailer 5-8-13 v5ntFINAL



February 19, 2013 by · Leave a Comment
Filed under: Health Care Economics, Health Law 

pasquale_frank_lg11A few years ago, I noted that the American Medical Association/Specialty Society Relative Value Scale Update Committee (RUC) has a dominant role in suggesting payment levels to CMS.  It raises hard questions about price-setting in the health care sector, many of which cannot be answered because its processes are opaque.  Now we know that judicial relief will not improve things any time soon.  As Brian Klepper reports, “On January 7, a federal appeals court rejected six Georgia primary care physicians’ (PCPs) challenge to the Centers for Medicare and Medicaid Services’ (CMS) 20-year, sole-source relationship with the secretive, specialist-dominated federal advisory committee that determines the relative value of medical services.”  What was the complaint?

The core of the … physicians’ legal challenge was that the RUC is a “de facto Federal Advisory Committee,” and therefore subject to the stringent accountability requirements of the Federal Advisory Committee Act (FACA). This law ensures that federal bodies have panel compositions that are numerically representative of their constituencies, that their proceedings are open, and that methodologies are scientifically credible. In other words, FACA ensures that advisory practices are aligned with the public interest.

The RUC adheres to none of these and is an object lesson in how special interests can be insinuated into and capture regulatory processes, displacing the public interest. For example, when the legal challenge was first filed, only 3 of 29 RUC panelists (10 percent) represented primary care, even though some 30 percent of US physicians practice primary care. RUC meetings are closed to the public, unless an invitation is extended by the Chair, and admission is tied to the guest signing a nondisclosure agreement. Determination of a procedure’s value has been based on as few as 30 survey responses by physicians who know that their reimbursement will be linked to how they have answered the questions.

This is a sad example of opacity in health pricing. In ordinary markets, publicity would tend to narrow the price differential between similar quality services.  In health care, however, there is a triple layer of agency between care and patients whose physicians’ recommendations are often constrained by an insurer that is chosen by the patient’s employer or government. Even if we assume away the agency problems in such an arrangement, it is difficult for buyers and sellers to truly understand “market” dynamics, or even the governmental processes that underlie them.

Originally posted at Health LawProf Blog.

Giving Patients a Piece of the Action: Appealing Proposals from Richard Frank and Christopher Robertson

February 10, 2013 by · Leave a Comment
Filed under: Health Law, Recommended Reading 

Kate Greenwood_high res 2011 compIn a recent edition of the New England Journal of Medicine, Richard Frank discussed recent efforts on the part of federal and state governments to enroll so-called “dual eligibles,” that is, individuals who qualify for both Medicare and Medicaid, into health plans that use “a strong care-management system under a unified budget.”  Many believe that such plans have the potential to both save the government money and provide better coordinated, higher quality health care.  (I discussed the need to better coordinate care for dually-eligible people here.)  Individual beneficiaries are not necessarily convinced, however.  Frank reports that it has been “very difficult to lure” them into “state-designed care coordination entities.”  Beneficiaries may be hesitant to leave their fee-for-service doctors and other providers; they may also be afraid of the incentive to restrict services that a capitated global payment creates.

To get beneficiaries to make the switch from fee-for-service to coordinated care, states are taking a page from Nudge and making enrollment in a coordinated care plan automatic.  The burden is then placed on the beneficiary to opt out if he or she so chooses.  The use of “passive enrollment” will no doubt “work” to increase the rolls of coordinated care plans, but Frank wants states to aim higher, to strive to “promote self-determination for vulnerable populations and offer them a reason to engage with a new care delivery system with coordinated-care arrangements[.]”

As Frank explains, “[c]oordinated care for dually eligible people is built on a financial structure known as shared savings, in which three of the parties involved –- the federal government and state governments and the [coordinated care plan] –- share any financial gains from coordinating care.”  Frank proposes that beneficiaries, too, be given a share of the expected savings– a share that they would be permitted to use to pay for “supplemental services and supports such as transportation, home modifications, and personal assistance with activities of daily living.”  The prospect of (limited) control over a share of the expected savings would serve as an incentive to beneficiaries to engage in care coordination, while also “promot[ing] self-determination and the exercise of real options.”

Frank’s very appealing idea brought to mind the proposal Christopher Robertson makes in The Split Benefit: The Painless Way to put Skin Back in the Healthcare Game, which is forthcoming in the Cornell Law Review.  While Frank would give beneficiaries an incentive to opt in to coordinated care, Robertson would give them an incentive to opt out of inefficient, high-cost care.  Specifically, Robertson proposes that when a physician “prescribes a high-cost treatment that the insurer reasonably believes is inefficient[,]” the insurer would “[p]ay a small but substantial part of the insurance benefit”—-what he terms the “split benefit”—-in cash directly to the patient beneficiary.  Then, “[i]f the patient chooses to proceed with the treatment, the patient takes the cash payment to the provider (along with any required cost share obligation), and the insurer matches it with the balance of the insurance benefit[.]”  Patients who choose not to proceed with treatment, however, could spend the cash differently, on a “treatment that is not covered by the insurer (whether it is acupuncture, an alternative diet regimen, a concierge doctor, or visiting nursing services), paying money to a member of the family to stay home and provide care to the dying patient, or purchasing disability insurance to help cope with the symptoms of the illness.”  They could even use the money to pay for non-health-related expenses.  As Robertson explains, the split benefit would save insurers (and, down the line, purchasers of insurance) money by giving beneficiaries a financial incentive to turn down high-cost, low-value treatments.  In Robertson’s words, the patient autonomy movement has been “cramped” by the fact that patients have been offered only “a walled garden of medical choices.”  His split benefit, by contrast, “embraces a value-pluralism, respecting the patient’s weighing of medical and non-medical values.”

I highly recommend both Frank’s and Robertson’s pieces to anyone who—-like me—-is interested in ways to give patients a piece of the action when it comes to the multiplicity of current efforts to coordinate and rationalize their care.


Physician Privileges and Employment Laws

January 10, 2013 by · Leave a Comment
Filed under: Health Law 

sullivan_charlesApparently, some hospitals are now requiring older physicians to undergo physical examinations as a condition of maintaining privileges. According to the Washington Post, this is in response to the aging of America’s physician population and some notable examples of physicians who have continued practicing long after their abilities have declined to unacceptable levels.  State licensing authorities don’t address the problem directly, thus impelling hospitals to do so. According to the Post, “a small but growing number of hospitals — including the University of Virginia Health System, Stanford Hospital and Clinics, and Driscoll Children’s Hospital in Corpus Christi, Tex. — have recently adopted policies requiring doctors over a certain age — 70 at U-Va. and Driscoll, 75 at Stanford — to undergo periodic physical and cognitive exams as a condition of renewing their privileges.”

Whether or not it is a good idea in the abstract, such a policy generates a number of legal questions. Most obviously, it raises the issue of whether such requirements can be squared with employment discrimination laws, in particular the Age Discrimination in Employment Act and maybe the Americans with Disabilities Act. If applicable, the former law would likely bar age-based examinations, and the latter might well preclude such examinations unless the hospital could document its concerns.

The quick response might be the traditional one: doctors with admitting privileges are not “employees” of hospitals, and, thus, are beyond the reach of employment discrimination statutes (including the ADEA and ADA) which only protect “employees” from discrimination by their “employers.” inapplicable.   But this might well be wrong for two reasons.

First, there is at least one recent court decision that suggests that the increasing control hospitals exercise over physicians who practice there might be sufficient to convert such physicians into employees.  Salamon v. Our Lady of Victory Hosp., 514 F.3d 217, 228-229 (2d Cir. 2008), reversed the district court’s finding in a sex discrimination case that plaintiff’s exercise of professional judgment was sufficient to negate employee status: the lower court’s “reasoning would carve out all physicians, as a category, from the protections of the antidiscrimination statutes.”  Rather, the proper focus was on the relationship between the parties, and, taking plaintiff’s allegations as true, the hospital “exercised substantial control not only over the treatment outcomes of her practice, but over the details and methods of her work. Members of the OLV administration were designated as her supervisors, with the job of ‘maintain[ing] continuing surveillance of [her] professional performance.’” In short, the hospital’s   application of its quality assurance standards might result in the requisite level of control to make plaintiff an employee. It is true that Salamon has not been much followed yet, but it’s definitely a straw in the wind.  Indeed, pay-for-performance and the variety of on-going CMS demonstration projects attendant to health care reform advance the trend of hospital influence if not control over physicians’ practice, thereby increasing the chances that other courts will be persuaded to subscribe to the Second Circuit’s analysis.

Second, and even if Salamon is wrong, hospitals have for years had some physician-employees and are now busy acquiring physician practice groups, see recent story here, and the acquired physicians may well be viewed as hospital employees. It’s possible, of course, that corporate structures will insulate the hospital from liability (although there will be many other considerations that factor into the decision how to structure the acquisition of a practice group), but that is by no means a sure bet.  Employment law has doctrines such as “integrated enterprise” and “joint employer,” which could render a hospital responsible as an “employer” for its privileging decisions under the antidiscrimination statutes regardless of the formal structure.  One might expect hospitals to claim that privileging is separate from any (direct or indirect) employment relation, but the notion that an employer could avoid liability by claiming its action were taken when it was wearing a non-employment hat may be a nonstarter.

That takes us back to whether requiring physical and cognitive examinations may violate the law.  We have ADEA cases that answer that question yes when the examinations are triggered by an age cutoff. In EEOC v. Massachusetts, 987 F.2d 64 (1st Cir. 1993), the court struck down a Massachusetts law requiring government officials to pass a physical examination at age 70 as a condition of continued employment. It’s true, as the Supreme Court had noted in EEOC v. Wyoming, 460 U.S. 226 (1983), an earlier case challenging retirement at age 55 for game wardens, that such a policy could be justified if the employer could show that the age criterion was a “bona fide occupational qualification.” However, the requirements of the “BFOQ” are stringent, and it is by no means clear that hospitals could satisfy them. For example, the varying ages pegged by the hospitals now using such policies – 70 and 75 – raise questions about the justification for the particular policies. Of course, subjecting a particular doctor to such tests on the basis of a reason to suspect declining competence would pose no ADEA problem, as long as such suspicion is truly formed on the basis of age-independent facts or occurrences.

As for the ADA, again assuming the hospital is an employer, the law is somewhat more complicated. Physical examinations (which presumably would include cognitive tests) are not prohibited entirely for current employees, but their permitted uses are limited. See EEOC Enforcement Guidance on Disability-Related Inquiries and Medical Examinations of Employees (July 27, 2000). Once employment has begun, an employer may require medical examinations only upon a showing that the inquiry or examination is job-related and consistent with business necessity. That would include situations where a physician’s performance raised doubts about her continued fitness.  Even a policy requiring all physicians to periodically undergo such tests (whether or not at a given age) is permissible when the demands of the job require checks of employees’ ability to do the job, with the burden on the employer to make the necessary showing.

Most of the cases upholding examinations are in law enforcement; indeed, the EEOC’s Guidance regarding periodic medical examinations is phrased in terms of “employees in positions affecting public safety (e.g., police officers and firefighters),” and its examples are limited to those contexts. Nevertheless, it’s not much of a stretch to bring physicians within this framework.  An analogy is theADA cases approving limitations because of the risk an HIV-positive provider poses to patients.

The more serious question is whether the examinations are narrowly tailored to address specific job-related concerns [and thus] are permissible.”  Further, of course, identification of a particular condition by such an examination is only the first step in the analysis. The EEOC requires an employer who decides to take an adverse action (in this context denying or severely limiting privileges) to “demonstrate that the employee is unable to perform his/her essential job functions or, in fact, poses a direct threat that cannot be eliminated or reduced by reasonable accommodations.

Further, there’s even a question about the intersection of the ADEA and ADA, although the courts haven’t addressed this yet.  Given the multiple physical and mental conditions that may affect physician performance, one might wonder why a hospital would use an age cutoff rather than conditioning all renewals of privileges on passing physical and cognitive tests.  This approach would conduce to patient safety and avoid any ADEA problems. On the other hand, such a policy might be too broad to pass muster under the ADA, since it might not be “narrowly tailored” to the most significant risks.

Finally, there is one more twist to this interesting problem: the ADA covers employment, but a separate Title bars discrimination on the basis of disability in “public accommodations.” While we tend to think of public accommodations as physical venues, there is at least one case that views a hospital as providing a public accommodation by virtue of its privileging decisions and therefore that the ADA applies to those actions. Menkowitz v. Pottstown Mem’l Med. Ctr., 154 F.3d 113 (3d Cir. 1998). This would suggest that the commands of that statute might have to be met entirely without regard to employment.  Still, as with a number of the matters previously discussed, the future trajectory of ADA public accommodation doctrine as applied to hospital privileging decisions remains highly uncertain.

Charles A. Sullivan

Andrea J. Catania Endowed Professor of Law

Seton Hall Law School



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