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May 27, 2015   Download print version

New Jersey man diagnosed with Lassa fever dies after Liberia trip

Toxic chemotherapy medical mystery

Oakwood Healthcare recognized for collaboration efforts between infection prevention and environmental services

Proposed medical-research law raises safety concerns

CMS proposes rule to strengthen managed care for Medicaid and CHIP Enrollees

New urine test could reduce need for blood samples

Money shortage threatens Ebola battle, WHO says



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June 2015

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New Jersey man diagnosed with Lassa fever dies after Liberia trip

State and federal health authorities said Tuesday that the death this week of a 55-year-old Essex County man in a Newark hospital from Lassa fever, a disease rarely seen in the U.S., poses an “extremely low” risk to the public.

The man, who traveled from Liberia in West Africa to Morocco to John F. Kennedy International Airport on May 17, had no symptoms and was not screened at the airport, according to the federal Centers for Disease Control and Prevention.

A day later, he went to an unnamed New Jersey hospital complaining of a sore throat, fever and fatigue. When asked his travel history, he did not mention his trip to West Africa, according to the CDC. The patient was sent home the same day, then returned to the hospital on May 21 when his symptoms worsened.

He was placed in isolation, according to the CDC and the state Department of Health, then transferred two days later to University Hospital in Newark, one of three medical centers in the state designated to treat viral hemorrhagic fevers, which include Ebola. Samples submitted to the CDC tested positive for Lassa fever Monday morning while tests for Ebola and other viral illnesses were negative. The patient was in isolation when he died Monday evening, according to the CDC.

“Given what we know about how Lassa virus spreads to people, we think the risk to the public is extremely low,” said State Epidemiologist Dr. Tina Tan.

University Hospital spokeswoman Stacie J. Newton said Tuesday that the man was in isolation for the duration of his care.

“We are taking every appropriate precaution to ensure the health and safety of our staff and are reviewing all staff contacts to establish if there was any risk exposure with this patient and educating staff and the public regarding Lassa fever,’’ Newton said.

Lassa fever is a viral disease that is common in West Africa, but rarely seen in the United States. Although Lassa fever can produce symptoms similar to Ebola, including diarrhea, vomiting and bleeding, the disease is much less fatal than Ebola — about one percent of cases compared to 70 percent for Ebola.

Lassa fever is not spread through casual contact or through the air and, according to the CDC, there has never been a person-to-person transmission of Lassa fever documented in the U.S. In rare cases, it can be transmitted through direct contact with a sick person’s blood or bodily fluids or through sexual contact.

In West Africa, Lassa virus is carried by rodents and transmitted to humans through contact with urine or the droppings of infected rodents. There have been 100,000 to 300,000 cases and 5,000 deaths. Countries reporting substantial outbreaks include Nigeria, New Guinea, Sierra Leone and Liberia, according to the CDC.

Out of an abundance of caution, the state Department of Health said it is working with hospital officials to identify anyone who had close contact with the victim, including healthcare workers and family members.

They will be monitored for symptoms for 21 days by the state in coordination with the staff of the two hospitals and local health officials. Visit North Jersey for the story.



Toxic chemotherapy medical mystery

The memories remain so vivid that Kathy Lang Albright still goes out of her way to avoid driving past the clinic where she received her first chemotherapy treatments. Albright, now 65, remembers how her legs shook with fear as she walked into the clinic for her fourth round of chemotherapy in November 2013, anticipating the ceaseless diarrhea that would follow, which made it nearly impossible for her to leave her home on the outskirts of Atlanta. She knew that a new crop of painful mouth sores would make swallowing excruciating. Her hands were sore and sunburned-looking, the skin on her eyelids was peeling and her feet were cracked, spotting her socks with blood. In less than six weeks she had lost 14 pounds.

Every time she asked the nurses who administered chemotherapy whether her side effects were normal, their answer was unvarying. Several months later, she would learn that there was a biological reason for her suffering, one that had been overlooked for months. Armed with that knowledge and a new oncologist, Albright completed cancer treatment last year, largely spared the toxic side effects that had made her so sick. Now in remission, she says she has made the transition from “cancer victim to one of cancer’s alumni.”

In August 2013 Albright began experiencing searing abdominal pain. Her internist diagnosed diverticulitis, an inflammation of the intestinal wall, and sent her to a gastroenterologist for a colonoscopy. The results of the colonoscopy revealed she did not have diverticulitis, but rather Stage 4 colon cancer, the most advanced form. The disease had spread to her liver.

In late September Albright and her husband met with an oncologist at their HMO to discuss treatment. He recommended a biweekly chemo regimen called FOLFOX for three to four months, followed by surgery to remove the tumor and then more chemo. The FOLFOX regimen, a standard treatment for colon cancer, consists of a cocktail of drugs: leucovorin, fluorouracil (also known as 5-FU) and oxaliplatin. Albright also received infusions of Erbitux, a drug approved to treat metastatic colon cancer.

By early December Albright was so sick she could barely stand up and went to the HMO’s urgent care center twice in one week. Initially, doctors who treated her during her five-day hospitalization suspected that Albright had contracted an infection, a consequence of an immune system weakened by chemotherapy. A CT scan revealed that her colon was severely inflamed. Galvanized by her ordeal, Albright began researching sensitivity to chemotherapy. She stumbled across a description of DPD deficiency, short for dihydropyrimidine dehydrogenase deficiency, which described many of the problems she had suffered.

DPD deficiency is an inherited metabolic disorder caused by mutations in the DPDY gene, which provides instructions for making an enzyme involved in breaking down two molecules when the body does not need them.

Mutations that result in complete deficiency are rare and are apparent in infancy; they are characterized by repeated seizures, small head size, delayed motor skills and intellectual disability. Cases of partial deficiency, believed to affect 2 to 8 percent of the population, show no symptoms — unless such a person is given certain chemotherapy drugs, including 5-FU, one of the drugs Albright received.

In these cases, 5-FU is not metabolized normally but instead accumulates to toxic levels, causing ulceration of the lining of the gastrointestinal tract, severe diarrhea, mouth sores called mucositis, low white blood cell counts and peeling skin on the palms and soles of the feet — all of which Albright experienced. If left untreated, death can result.

In late December 2013, Albright began seeing Robert Allen, the Atlanta oncologist who had successfully treated her friend for colon cancer. Albright said that at their first meeting Allen reviewed her records, then told her that based on his calculations, she had received an overdose of chemo: 30 percent too much for her weight and height. Visit the Washington Post for the story.



Oakwood Healthcare recognized for collaboration efforts between infection prevention and environmental services

PDI has announced that Oakwood Healthcare in Dearborn, MI, has been selected as the winning entry in Delivering the Difference, a contest recognizing industry professionals who display excellence in building collaborative relationships between infection prevention (IP) and environmental services (ES) teams in healthcare facilities.

Oakwood Healthcare's infection preventionist, Priscila Bercea, collaborated with environmental services regional manager, Alissa Bachnak, and the corporate IP and ES teams to address key challenges, including poor compliance with routine cleaning of high-touch areas and multi-use equipment, overuse of bleach products resulting in surface damage and general education deficiencies around product use.

Together, the teams established a structured approach that improved environmental hygiene and networking across the entire healthcare system. The following key initiatives developed through the successful collaboration continue to drive positive results for the facility:

·         Implementation of a recognizable product line that is strategically placed in the appropriate rooms

·         Installation of brackets on mobile and multi-use equipment to promote ease-of-use

·         Placement of educational posters and contact time stickers on all compliance tools to clearly communicate the "what, when and how" of each product

·         Establishment of a monthly Infection Control Liaison Program composed of the IP, a clinical staff member and an ES liaison from every department to share important data and facilitate discussion

·         Attendance by both the infection preventionist and ES management director at monthly corporate IP and ES meetings

"We are honored and proud to be recognized by PDI and Delivering the Difference for the improvements and collaboration we implemented in our facilities," said Bercea. "The journey over the past few years between infection prevention and environmental services has increased our mutual passion toward a positive patient outcome and family experience."

PDI will host a booth at the 2015 APIC Annual Conference in Nashville, TN from June 27 to 29, 2015, and Bercea and Bachnak will be part of a presentation on Delivering the Difference where they will share a case study on Oakwood Healthcare. They will also present with PDI at the 2015 AHE Exchange in Grapevine, TX. on September 21, 2015. PDI continues to have a strong partnership with both APIC and AHE. Visit here for the release.



Proposed medical-research law raises safety concerns

Legislation aimed at boosting U.S. medical research funding and revamping some rules over drug and medical-device safety is headed toward a vote in the full House of Representatives, likely in June.

But while the bill, known as the 21st Century Cures Act, passed the House Energy & Commerce Committee unanimously last week and opposition has been muted, some critics are beginning to question whether it would open the way for companies to sell drugs and devices that aren’t fully tested.

The measure would boost funding for the cash-strapped National Institutes of Health by $10 billion over five years. The federal research agency would be allowed to use some of that money for President Barack Obama’s $215 million “precision-medicine” initiative, which among other things would create an enormous database of genomic information obtained from one million U.S. patients who volunteer to participate.

The bill would offset some of the costs by changing the timing of certain government payments to prescription drug plans for Medicare drug benefits. America’s Health Insurance Plans said that change will narrow drug coverage for America’s seniors.

Rep. Fred Upton (R., MI.), chairman of the House committee, told The Wall Street Journal that the bill “is about unleashing a whole new generation of health-care innovation and hope for patients. Rather than reacting to a single health crisis or reforming a single piece of the innovation puzzle, we are addressing the entire system.”

The bill was authored by Upton along with others, including the committee’s top Democrat, Rep. Frank Pallone of New Jersey; Rep. Diane DeGette of Colorado, the top Democrat on the Oversight and Investigations subcommittee; Health subcommittee chairman, Rep. Joe Pitts (R., PA), and Health subcommittee’s top Democrat, Rep. Gene Green of Texas.

The Senate isn’t expected to consider parallel legislation until at least late in the year. The House bill includes a number of pro-industry initiatives regarding drug approval and regulation of drug marketing by the Food and Drug Administration.

The health advocacy group Public Citizen, in a letter last week to House members, cited several portions of the bill that it says “would undermine public health and threaten patient safety.”

Antibiotics are an example. They are a cause of great concern now, since several have become less effective because of drug-resistant bacteria. The bill would ease certain requirements for approval of new antibiotics. In a letter to the House committee, 23 public-health groups announced their support for the provision, saying, “It is often not feasible for these drugs to be developed using traditional, large clinical trials.” The groups include the Infectious Diseases Society of America and the American Academy of Pediatrics. Visit the Wall Street Journal for the report.



CMS proposes rule to strengthen managed care for Medicaid and CHIP Enrollees

The Centers for Medicare & Medicaid Services (CMS) proposed to modernize Medicaid and Children’s Health Insurance Program (CHIP) managed care regulations to update the programs’ rules and strengthen the delivery of quality care for beneficiaries. This proposed rule is the first major update to Medicaid and CHIP managed care regulations in more than a decade.

It would improve beneficiary communications and access, provide new program integrity tools, support state efforts to deliver higher quality care in a cost-effective way, and better align Medicaid and CHIP managed care rules and practices with other sources of health insurance coverage. Overall, this proposed rule supports the agency’s mission of better care, smarter spending, and healthier people.

Since CMS last issued managed care regulations in 2002 and 2003, the healthcare delivery landscape has changed and grown substantially. States have expanded managed care to several new populations including seniors and persons with disabilities. The growth of managed care in the Marketplace and Medicare Advantage further highlights the importance of policy alignment when appropriate across programs in order to ease the transition for consumers whose circumstances change during the year.

CMS proposes to modernize Medicaid managed care regulations in the following ways:

·         Supporting states’ efforts to encourage delivery system reform initiatives within managed care programs that aim to improve healthcare outcomes and beneficiary experience while controlling costs; and

·         Strengthening the quality of care provided to beneficiaries by strengthening transparency and measurement, establishing a quality rating system, and broadening state quality strategies and consumer and stakeholder engagement;

·         Improving consumer experience in the areas of enrollment, communications, care coordination, and the availability and accessibility of covered services;

·         Implementing best practices identified in existing managed long term services and supports programs;

·         Aligning Medicaid managed care policies to a much greater extent with those of Medicare Advantage and the private market;

·         Strengthening the fiscal and programmatic integrity of Medicaid managed care programs and rate setting;

·         Aligning the CHIP managed care regulations with many of the proposed revisions to the Medicaid managed care rules strengthen quality and access in CHIP managed care programs. 

The proposed rule is available here and can be viewed at the Federal Register web site starting June 1. The deadline to submit comments is July 27, 2015.

Visit here for the CMS Fact Sheet.



New urine test could reduce need for blood samples

If you've been to the doctor, you probably know what to do when you're handed a plastic cup and shown to the bathroom. Most patients hand over the sample and give little thought to what happens when it's shipped to the lab for analysis.

Ken Marcus and his students are the exceptions. They have developed a new testing method that they believe will reduce costs, get faster results and lower the volume of urine needed for a sample.

It's great news for patients who get the willies when the nurse pulls out the needle to draw blood. The method Marcus and his students have developed could help make it possible to use urine instead of blood to test for more diseases.

Proteins in urine, for example, could help detect early signs of coronary heart disease, tell whether the body is rejecting a transplanted kidney and show whether someone has sleeping sickness.

The trouble with testing urine is that it's awash in salt, Marcus said. It can be tricky to isolate the proteins that act as biomarkers. Those biomarkers are the clues that tell whether the patient is sick or has ingested a drug.

The magic ingredient in the group's research looks like kite string, but it's no ordinary twine. It's made of capillary-channeled polymer fibers.

As part of a study, Marcus and his students packed the fibers into plastic tubes and then passed urine samples through the tubes by spinning them in a centrifuge for 30 seconds. Then the researchers ran de-ionized water through the tubes for a minute to wash off salt and other contaminants.

Proteins are hydrophobic, so they remained stuck to the fibers. Researchers extracted the proteins by running a solvent through the tubes in the centrifuge for 30 seconds.

When it was all done, researchers were left with purified proteins that could be stored in a plastic vial and refrigerated until it's time for testing. The team was able to extract 12 samples in about five minutes, limited only by centrifuge capacity.

In urine tests commonly used now, polymer beads extract the proteins.

The team's work was recently published by the journal Proteomics-Clinical Applications. The authors were Benjamin T. Manard, Sarah M.H. Jones and Marcus.

In a review of the article, professor Youhe Gao of Beijing Normal University wrote that the method "may have more profound implications than the authors have claimed, simply because urine is more important than most biomarker researchers realize."

Various mechanisms in the body limit changes in the blood. Urine, however, "accumulates all kinds of changes and should be a better biomarker source than blood," Gao wrote.

Further, urine is the mostly easily obtained bodily fluid, he wrote. Sweat can also be obtained noninvasively, but it may not be as informative and free of contaminants as urine, Gao wrote.

The new method should also make it easier to test urine samples from babies, Marcus said. One of the challenges now is getting a large enough sample. But the new method requires only a few microliters of urine. Visit Science News for the study.



Money shortage threatens Ebola battle, WHO says

The numbers of Ebola cases in Sierra Leone and Guinea have been rising and falling since Liberia was declared Ebola-free on May 9. The World Health Organization says that the road to zero will be bumpy, but that for the most part, progress in stopping transmission of the virus has been good.

The latest WHO figures put the number of cases in the three West African countries at 27,001, with 11,132 deaths.  Over the past week, WHO reported 12 new cases of the disease — nine in Guinea and three in Sierra Leone, from a total of five districts or prefectures.  

Bruce Aylward, WHO assistant director-general for emergencies, said this was a good sign. “That is another bit of a landmark and important to recognize," he said. "Over the past month, we have been dealing with six or fewer districts and prefectures with active transmission. That is the lowest number of infected areas that we have been dealing with for a full year. So there is real progress in terms of the numbers, in terms of the geography.”

While the trends are positive, Aylward said it would take time to get the job done. He noted that Liberia took four months from the time it hit a similar caseload to get to zero cases.  Aylward said that in the best-case scenario, Sierra Leone and Guinea could be Ebola-free by September, but that a likelier scenario would be for them to reach that goal by the end of the year.

Aylward said many challenges lie ahead, including the rainy season, during which it will be extremely difficult to move people and supplies around, fly helicopters to remote areas and ensure water is not leaking into treatment centers.

Moreover, he said, during the rainy season there is an surge in diseases such as malaria and diarrhea, which present symptoms that often are mistaken for Ebola.

Another, perhaps bigger challenge, Aylward said, is lack of money. “Money is falling faster than cases. ... The situation with respect to the logistics of the rainy season and the operations — that is getting sorted out. The financing of it is not, and that is the challenge," he said. "There is no reason that Ebola cannot be beaten, but financing is increasingly becoming the most glaring potential reason for failure.”

The rains already have begun in West Africa, and they will become extremely heavy and unmanageable in June and July. Aylward said the World Food Program would need $50 million to fly people and supplies to remote Ebola-stricken areas over the next six months.  

He said the WHO had been told to tighten its belt, but even after doing that, he added, the agency still is $100 million short of what it needs to run its many lifesaving operations.  Aylward said the United Nations was developing a revised budget to include all U.N. agencies working on Ebola relief in West Africa. Visit Voice of America for the story.