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August 4, 2015   Download print version

Variety of medical scopes pose the risk of serious infection

CDC funding helps states address infectious disease threats

Half of nation’s hospitals fail again to escape Medicare’s readmission penalties

Lawsuit accuses CVS of overcharging for generic drugs

SMI releases new executive briefing on the impact of RFPs in the healthcare supply chain

Drones might fly blood samples to clinics, study finds

IBM Watson Health now counts CVS Health as a partner

Docs report patient safety often at risk in ER to inpatient handoff


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August 2015

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Variety of medical scopes pose the risk of serious infection

A doctor reported in December that a medical scope commonly used to examine patients' lungs had infected 14 people with a superbug that kills half its victims.

Yet another type of scope, used to see inside the bladder, sickened three patients with a different bacteria in March, according to a nurse. The device was sent to the manufacturer, which found "foreign substances" inside despite cleaning.

And in November, a nurse manager reported that seven patients were infected with an often lethal bacteria known as clostridium difficile from a device used for colonoscopies.

The three outbreaks are among dozens of injury reports in a federal database that detail how the risk of serious infection from contaminated scopes is far broader than a specialized device that recently sickened patients at UCLA, including three who died.

Regulators have blamed the intricate design of that device — a duodenoscope — for being especially hard to clean. But in the last three years, patients have also been exposed to bacteria — and to human tissue and dried blood — left inside a variety of scopes commonly used to examine the lungs, the colon, the bladder and the stomach, according to the reports.

Infection experts have been warning for years in speeches and research papers that many types of endoscopes can remain dirty after cleaning — only to have their concerns mostly ignored by doctors performing the procedures.

Federal regulators say they don't know how many patients have been sickened by the scopes, which as a group are used tens of millions of times each year. There are no numbers to quantify the risk because few of the scope-caused infections get reported. The government's injury reporting system, which keeps names of hospitals and clinics secret, is mostly voluntary.

The cases reported to the Food and Drug Administration show a repeated story: The scope transferred bacteria among patients even though medical staff believed it had been disinfected. And in many cases, multiple patients were sickened before doctors recognized that the scope harbored bacteria inside its long narrow channel or delicate mechanisms.

As the scopes snake through a patient's throat, intestine and other cavities, they are contaminated with mucus, blood and millions of microbes. But the delicate devices can't be sterilized like a surgeon's knife because intense heat would destroy them.

Instead the scopes are brushed, washed with disinfectants, rinsed and dried according to manufacturers' instructions, a process performed by technicians that may require a hundred steps.

In 2010, the Palomar Health system in San Diego County notified 3,400 patients that they may have been exposed to tainted scopes after workers continued for months to use a disinfectant that was past its expiration date.

Scope manufacturers have said they often find that hospitals reporting infections did not properly clean or maintain the device.

For example, Olympus told the FDA that the bronchoscope that had potentially infected 14 patients with CRE, or carbapenem-resistant enterobacteriaceae, in December had been sent to an unregulated company for repair.

That case was the third reported outbreak suspected to be caused by an Olympus bronchoscope in less than three weeks. In one of those outbreaks, a nurse reported that three people were sickened by another often deadly bacteria.

Even when the recommended disinfection guidelines are followed correctly, it's sometimes not enough. Biofilms can form inside the scopes, making them extremely hard to clean.

Only after the UCLA outbreak was revealed in February did the FDA take action. In March, the agency began requiring manufacturers asking for regulatory approval of a new scope to provide studies proving that it can be disinfected. The agency had proposed the rules four years ago, but did not approve them until news of the deadly Los Angeles outbreak raised public concerns.

The new rules don't apply to devices already on the market. That means hospitals will continue to use current scopes for years. The rules also do not cover cystoscopes, used to examine the bladder, and gastroscopes, used to look inside the stomach. According to the FDA's injury database, those devices have also been found to be dirty after cleaning.

Jennifer Dooren, an FDA spokeswoman, said the agency believes the scopes currently on the market are safe. She said it took the agency four years to finalize the rules because it had received hundreds of comments on the proposal, including some raising key scientific issues. She noted the agency had warned hospitals about improperly cleaned scopes in 2009. The FDA is continuing to monitor reports of scope-related infections, Dooren said, to see if it should do more.

In May, some members of an expert panel created to advise the FDA on improving the safety of duodenoscopes expressed alarm about the even broader danger from the other types of scopes. Visit the Los Angeles Times for the report.


CDC funding helps states address infectious disease threats

The Centers for Disease Control and Prevention (CDC) announced awards of nearly $110 million to help states and communities strengthen their capacity to track and respond to infectious diseases. The awards represent an increase of about $13 million over fiscal year 2014 funding, with increases going to vaccine-preventable-disease surveillance, foodborne-disease prevention and advanced molecular detection, among other projects.

The funding is allocated through the Epidemiology and Laboratory Capacity for Infectious Diseases Cooperative Agreement (ELC), with a goal of helping states fight infectious disease outbreaks more quickly and develop better interventions to protect the public’s health. Of the nearly $110 million, $51 million is provided through the Affordable Care Act’s Prevention and Public Health Fund.

 â€śIn the last year alone, states were hit with emerging diseases, like chikungunya and respiratory infections from enterovirus D-68, while also responding to outbreaks of measles, foodborne illness, and other threats. These awards lay the foundation for those on the front lines – state and local health departments – to act quickly to prevent illness and deaths,” said Beth P. Bell, M.D., MPH, director of CDC’s National Center for Emerging and Zoonotic Infectious Diseases.

This year’s funding includes:

·         $6 million to establish local, state and territorial health coordinators to track vaccine-preventable diseases like measles and pertussis.

·         $17.4 million for foodborne disease prevention and tracking – a $4 million increase over fiscal year 2014 funding. This includes increased support for the PulseNet surveillance system and outbreak response and for the Integrated Food Safety Centers of Excellence to establish a new Northeast Regional center.

·         More than $2 million to help states build their capacity for advanced molecular detection, an emerging field that combines next-generation genomic sequencing with bioinformatics to more quickly identify and respond to disease outbreaks.

·         Approximately $1.5 million to help states fight Lyme and other tickborne diseases. CDC research shows that Lyme disease has been spreading geographically in recent years and CDC estimates that it affects about 300,000 people per year.

·         Approximately $9.2 million to aid state, local, and territorial health departments in building and maintaining disease detection, surveillance, and prevention programs to reduce the number of human infections with West Nile virus and other mosquito- and tick-borne arboviruses.

Resources to help states on the U.S.-Mexico border prepare for and respond to potential outbreaks of the mosquito-borne chikungunya virus. Chikungunya surfaced in the Western Hemisphere for the first time in late 2013 and last year infected more than 1.5 million people throughout the Caribbean, Mexico and Central America.

For more information on CDC’s ELC cooperative agreement and the breakdown of FY15 funding, please visit here.

Visit CDC for the release.


Half of nation’s hospitals fail again to escape Medicare’s readmission penalties

Once again, the majority of the nation’s hospitals are being penalized by Medicare for having patients frequently return within a month of discharge — this time losing a combined $420 million, government records show.

In the fourth year of federal readmission penalties, 2,592 hospitals will receive lower payments for every Medicare patient that stays in the hospital — readmitted or not — starting in October. The Hospital Readmissions Reduction Program, created by the Affordable Care Act, was designed to make hospitals pay closer attention to what happens to their patients after they get discharged.

Since the fines began, national readmission rates have dropped, but roughly one of every five Medicare patients sent to the hospital ends up returning within a month.

Some hospitals view the punishments as unfair because they can lose money even if they had fewer readmissions than they did in previous years. All but 209 of the hospitals penalized in this round were also punished last year, a Kaiser Health News analysis of the records found.

The fines are based on readmissions between July 2011 and June 2014 and include Medicare patients who were originally hospitalized for one of five conditions: heart attack, heart failure, pneumonia, chronic lung problems or elective hip or knee replacements. For each hospital, Medicare determined what it thought the appropriate number of readmissions should be based on the mix of patients and how the hospital industry performed overall. If the number of readmissions was above that projection, Medicare fined the hospital.

Medicare is penalizing hospitals that see patients return to the hospital too soon after being discharged. Medicare reduces what it pays each hospital per patient, per stay.

Medicare Readmission Penalties By Hospital (.pdf)

Medicare Readmission Penalties By State (.pdf)

The fines will be applied to Medicare payments when the federal fiscal year begins in October. In this round, the average Medicare payment reduction is 0.61 percent per patient stay, but 38 hospitals will receive the maximum cut of 3 percent, the KHN analysis shows. A total of 506 hospitals, including those facing the maximum penalty, will lose 1 percent of their Medicare payments or more.

Overall, Medicare’s punishments are slightly less severe than they were last year, both in the amount of the average fine and the number of hospitals penalized. Still, they will be assessed on hospitals in every state except Maryland, which is exempt from these penalties because it has a special payment arrangement with Medicare.

Most of the 2,232 hospitals spared penalties this year were excused not because Medicare found readmissions to be sufficiently infrequent, but because they were automatically exempted from being evaluated — either because they specialized in certain types of patients, such as veterans or children, because they were specially designated “critical access” hospitals, or because they had too few cases for Medicare to accurately assess. Visit Kaiser Health for the story.


Lawsuit accuses CVS of overcharging for generic drugs

CVS deliberately overcharged some pharmacy customers for generic drugs by submitting claims to their insurance companies at inflated prices, according to a lawsuit filed on Thursday in federal court in San Francisco. The suit says those inflated prices led to higher co-pays for customers that exceeded what they would have paid for the drugs if they had no insurance and participated in a CVS discount program.

“We’ve seen people who pay $20 for a 30-day supply as their copayments on a drug that was $11.99 for a 90-day supply had they been in the (discount program),” said Kristen Broz, an attorney with the firm that filed the suit.

The lawsuit seeks class action status, a court order prohibiting CVS from engaging in the behavior and unspecified damages.

Broz estimated that hundreds of thousands of people may have been affected since 2008.

At issue in the lawsuit is CVS’s “Health Savings Pass” program, which offers discounts to customers who do not have insurance or choose not to use insurance on hundreds of generic prescription drugs, including generic versions of the antibiotic Penicillin and the anti-depressant Prozac, according to the suit. Instead of presenting insurance companies with that discounted price, CVS reported the higher price that a normal retail customer not in the Health Savings Pass would pay, the lawsuit alleges. Customers were then charged co-pays according to those higher prices. (Associated Press) Visit WFLA for the story.


SMI releases new executive briefing on the impact of RFPs in the healthcare supply chain

The Strategic Marketplace Initiative (SMI) released a new executive briefing for the healthcare supply chain industry entitled “RFP Activity:  A Contributor to Industry SG&A Costs”. This document is available, at no-charge, on the SMI website at and is designed to help increase awareness of the impact that RFPs contribute to industry SG&A costs as well as promote industry actions that could potentially lower SG&A costs for providers and suppliers.

This comprehensive document was developed by a team of SMI members, all healthcare supply chain executives, who set out to identify “improvement opportunities” that the industry could explore to lower the sales, general, and administrative (SG&A) costs in the healthcare industry. While there are many behaviors and practices that contribute to high SG&A costs, the SMI Team identified the industry’s approach and utilization of the request for proposal (RFP) process, as an area worth exploring.   

This briefing is a culmination of research and survey data collected by the SMI team that shows how RFP volumes and the supplier costs to respond to these RFPs have increased over the past 12 months. The briefing also includes information obtained from supplier interviews and how one supplier was able to reduce their RFP response time by 28%.

Dennis Orthman, SMI Senior Director said, “Through publication of this briefing, this SMI team hopes to increase overall industry awareness of the costs associated with RFP activities, while also encouraging both buyers and sellers to take actions that may reduce and control these costs better through more efficient practices.”

This resource, along with 29 other downloadable tools and solutions are available on the SMI website, and are designed to help industry professionals address real supply chain issues and challenges. 


Drones might fly blood samples to clinics, study finds

Johns Hopkins University researchers found that common and routine blood tests were not affected when blood samples spent up to 40 minutes traveling on hobby-sized drones.

The findings from test flights in the United States are promising news for patients in areas with poor road networks. Drones could give isolated medical clinics quick access to lab tests required to diagnose and treat health problems, the researchers said.

After this successful proof-of-concept study, the next step would be to test the use of drones in Africa where health care clinics are sometimes 60 miles or more away from testing labs, the researchers said.

"A drone could go 100 kilometers [about 62 miles] in 40 minutes," study author Dr. Timothy Kien Amukele, a pathologist at the Johns Hopkins University School of Medicine in Baltimore, said in a university news release. "They're less expensive than motorcycles, are not subject to traffic delays, and the technology already exists for the drone to be programmed to 'home' to certain GPS coordinates, like a carrier pigeon," he explained.

Amukele pointed out that drones have already been tested as carriers of medicines to clinics in remote areas. The U.S. National Institutes of Health has more about blood tests. (HealthDay) Visit US News for the article.


IBM Watson Health now counts CVS Health as a partner

IBM’s data service for the healthcare industry, Watson Health, now has CVS Health as a partner, joining Apple, Medtronic, and others.

The pharmacy chain now joins the ranks of other Watson Health partners, including Apple, Johnson & Johnson, and Medtronic, which are using Watson to build their own healthcare services on top of.

The goal of the partnership is to make Watson’s number-crunching technology available for healthcare professionals working at CVS Health, which operates roughly 7,800 drugstores. Ultimately, CVS Health wants to use Watson to analyze patient data and improve patient care.

With pharmacies having access to boatloads of healthcare data, like health records and medical claims information, IBM claims that Watson technology could help them better understand a patient’s overall health.

The partnership will also address patients with declining health “who may benefit from proactive, customized engagement programs” created by healthcare providers with the help of Watson, according to the announcement.

The announcement is the latest in IBM’s plans to make its Watson data analytics technology a viable business. The company does not currently share exactly how much revenue Watson is contributing to IBM’s bottom line. Visit Fortune for the release.


Docs report patient safety often at risk in ER to inpatient handoff

Physicians report that patient safety is often at risk during the emergency department admission handoff process due to ineffective communication. Christopher J. Smith, M.D., from the University of Nebraska Medical Center College of Medicine in Omaha, and colleagues surveyed resident, fellow, and faculty physicians directly involved in admission handoffs from emergency medicine and five medical admitting services at a 627-bed tertiary care academic medical center.

Based on responses from 94 admitting and 32 emergency medicine physicians, the researchers found that admitting physicians reported that vital clinical information was communicated less frequently for all content areas (P < 0.001), compared to emergency medicine physicians. Nearly all (94 percent) of emergency medicine physicians felt defensive at least "sometimes."

Just under one-third of all respondents (29 percent) reported handoff-related adverse events, most frequently related to ineffective communication. Sequential handoffs were commonly reported for both emergency medicine and admitting services, and 78 percent of physicians reported that these handoffs negatively impact patient care. (HealthDay) Visit Medical Express for the report.