A Weekly Compilation of Clinical Laboratory and Related Information
from The Division of Laboratory Science and Standards
August 08, 2013
View Previous Issues - Healthcare News Archive
Lawmaker Introduces Bill to Close Self-Referral Loophole
Lab and pathology groups are applauding introduction Aug. 1 of legislation that would close the self-referral loophole in the Stark statute. The bill, Promoting Integrity in Medicare Act of 2013, would exclude anatomic pathology, advanced diagnostic imaging, physical therapy, and radiation therapy services from the in-office ancillary services (IOAS) exception to the law prohibiting physician self-referrals. Recent reports from the Government Accountability Office, the Health and Human Services Office of Inspector General, and peer-reviewed studies have criticized the self-referral loophole, charging that such referrals drive up utilization and Medicare costs.
Legislators Call for Ban on Radiation Therapy Self-Referral
Federal legislators are pushing a ban on self-referral in radiation therapy in the wake of a U.S. Government Accountability Office report on the impact of physician financial incentives on prostate cancer treatments. The GAO report (PDF) found that the number of prostate cancer-related intensity-modulated radiation therapy, or IMRT, services performed by self-referring groups increased from about 80,000 to 366,000 between 2006 and 2010 while declining among non-self-referring groups. The bill is supported by the American Clinical Laboratory Association, American College of Radiology, American Physical Therapy Association, American Society for Clinical Pathology, American Society for Radiation Oncology, Association for Quality Imaging, the College of American Pathologists and the Radiology Business Management Association.
Medicare Slaps Two-thirds of US Hospitals With Readmission Penalties
Two-thirds of the nation's hospitals will get hit with fines in the second round of Medicare's readmission penalties, according to data released by the Centers for Medicare & Medicaid Services. For the upcoming year, 2,225 of the nation's 5,700 hospitals will receive payment reductions totaling $227 million starting on Oct. 1. Of those hospitals, 18 hospitals will lose 2 percent of Medicare reimbursements, the top penalty, while 154 will lose 1 percent or more. In the first round of penalties, almost 300 hospitals received the maximum fine--a 1 percent loss of their base Medicare payments, FierceHealthFinance previously reported.
Oregon Surgeons Must Disclose Implant Conflicts
The Oregon Department of Justice says doctors who are paid by makers of artificial implants must disclose the possible conflict of interest to patients. The action involves two Salem doctors who agreed to pay $25,000 each to settle a state Justice Department case involving pacemakers and defibrillators. The Oregonian reports the action is the first of its kind and could set a precedent for disclosing payments to doctors from implant makers. Most hospitals do not require patients to be informed of such payments. The Justice Department says patients need to know about any possible conflict of interest when a device is selected.
Patient Groups to Federal Officials: Don't Rush Health IT Regulation
A coalition of 15 patient groups said it wants to see the Food and Drug Administration Safety Innovation Act workgroup take its time in crafting a risk-based framework for health IT regulation, in a letter sent to federal officials this week. The letter piggybacks on a similar letter last month that called on the Obama administration to work with congress on health IT oversight, and suggested that congress also look to revise the Food, Drug and Cosmetic Act "to reflect the explosive growth in and rapidly evolving nature of information technology in healthcare."
ONC Chief Mostashari to Step Down
Dr. Farzad Mostashari will step down this fall as head of the Office of the National Coordinator for Health Information Technology at HHS after two years in the position. The announcement came in an e-mail to staff by HHS Secretary Kathleen Sebelius. “During this time of great accomplishment, Farzad has been an important adviser to me and many of us across the department,” Sebelius said. “His expertise, enthusiasm and commitment to innovation and health IT will surely be missed. In the short term, he will continue to serve in this role while a search is underway for a replacement.
FDA to Scrutinize HPV Test Linked to False Readings
Labs have been using test kit that is approved for Pap test, but not HPV testing.
Food and Drug Administration regulators say they will tighten oversight of problematic diagnostic medical tests — including a test used to screen for the virus that causes cervical cancer that was the subject of an Arizona Republic investigation this year. That investigation described how laboratories across the country continued to use a test kit, BD SurePath, to screen women for human papillomavirus, or HPV, more than six months after government warnings that SurePath can produce false negatives, incorrect results that suggest a woman doesn't have the virus. HPV causes nearly all cervical cancers, and a false negative can tell women they are free of HPV when they aren't, leading to delays in diagnosis and treatment.
Earth's Life-Forms Collected to Aid in Genetic Research
The Smithsonian plans to create a huge bank of genetic samples to enable study of the planet's diversity through DNA sequencing. It took a decade and nearly $3 billion to completely sequence the human genome. Now researchers at the Smithsonian National Museum of Natural History are helping to tackle Earth's remaining 1.3 million species through the Global Genome Initiative. The plan is to eventually freeze embryos, seeds, and other genetic samples from as many of Earth's life-forms as possible.
USDA Reviews Whether Bacteria-Killing Chemicals Are Masking Salmonella
The Agriculture Department is reviewing research showing that new bacteria-killing chemicals used in chicken slaughterhouses may be masking the presence of salmonella and other pathogens that remain on the birds that consumers buy, according to records and interviews. Academic researchers agree that the chemicals could be overwhelming an antiquated testing process. Several of the scientists have been enlisted by the USDA’s food safety experts to help resolve the matter.
Test Utilization: A United Front Against Waste
It took only a simple intervention to slash daily phlebotomy charges at one tertiary care hospital. In their 2011 article, “Surgical vampires and rising health care expenditure” (Arch Surg. 2011:146:524–527), Elizabeth A. Stuebing, MD, and Thomas Miner, MD, report on how they reduced the cost of daily phlebotomy by announcing each week to surgical house staff and attending physicians the dollar amount charged to nonintensive care unit patients for laboratory services. After 11 weeks, the charges for daily phlebotomy had dropped from $147.73 to $108.11 per patient per day. It was a classic study, not only demonstrating that knowledge is power, but also that process improvement begins by the mere act of monitoring the process. In business, the maxim is known as the Hawthorne effect, says A. Neil Crowson, MD, chief of staff at St. John Medical Center and president of Pathology Laboratory Associates, Tulsa, Okla.
Increase in Urine Testing Raises Ethical Questions
As doctors try to ensure their patients do not abuse prescription drugs, they are relying more and more on sophisticated urine-screening tests to learn which drugs patients are taking and — just as important — which ones they’re not. The result has been a boom in profits for diagnostic testing laboratories that offer the tests. In 2013, sales at such companies are expected to reach $2 billion, up from $800 million in 1990, according to the Frost & Sullivan consulting firm. The growing use of urine tests has mirrored the rise in prescriptions for narcotic painkillers, or opioids. But the tests, like earlier efforts to monitor opioid prescribing, have led to a host of vexing questions about what doctors should do with the information they obtain, about the accuracy of urine screens and about whether some companies and doctors are financially exploiting the testing boom.
New Cancer Biomarker Tests Stunted by 'Vicious Cycle'
Cancer biomarker test development and adoption has "lagged far behind" recent advances in cancer therapies, according to a commentary published in the July 31 issue of Science Translational Medicine. "Despite prodigious advances in tumor biology research, few tumor biomarker tests have been adopted as standard clinical practice," write the authors, a blue ribbon panel of representatives from industry, academia, and professional organizations led by Daniel Hayes, MD, clinical director of the breast oncology program at the University of Michigan Comprehensive Cancer Center in Ann Arbor. This is a problem for a variety of reasons, including that fact that clinicians need tools to identify the patients who will most likely benefit — or definitely not benefit — from therapies, they explain. Without robust biomarker testing, the "promise of personalized medicine" in oncology is being jeopardized, the authors say.
The authors identify 5 causes of the resulting vicious cycle of second rate operations and related recommendations that would break the cycle. "These recommendations are not about creating more regulation; they are about creating an even playing field that allows tumor biomarker tests to be developed and proven clinically relevant. We want to stimulate innovation yet hold investigators and clinicians to the highest scientific standards — as we now do for therapeutics," Dr. Hayes said in a press statement. "We need to change the way we value tumor biomarkers in this country."
Test Quickly Detects Black Death
Diagnosing the presence of Yersinia pestis, the cause of plague, may soon be easier than ever before. Scientists working with Peter Seeberger, Director at the Max Planck Institute of Colloids and Interfaces (MPIKG) in Potsdam and professor at the Freie Universität Berlin, have come up with a simple, inexpensive and reliable method of detecting the bacterium. The research team, specializing in glycochemistry glycobiology, first identified and synthesized an oligosaccharide structure on bacterial surface before combining it with a protein to heighten the immunological effect. The presence of antibodies against this surface glycan in the blood of infected patients can be a biomarker of diagnostic value in Yersinia pestis infections. The Potsdam-based scientists also used the antigen to create antibodies that can directly detect the plague pathogen in infected samples.
Blood Test Determines Reduced and Oxidized Glutathione
Diminished levels of glutathione (γ-glutamylcysteinylglycine, GSH) and the ratio of GSH to glutathione disulfide (GSSG) can serve as important indicators of oxidative stress and disease risk. A simple and sensitive liquid chromatography-tandem mass spectrometry (LC–MS/MS) method for measuring whole blood GSH and GSSG has been developed and can easily be implemented in clinical laboratories. Scientists at Stanford University School of Medicine (CA, USA) developed an approach that minimizes preanalytical variability through a one-step procedure of deproteinization and derivatization that prevents artifactual oxidation of GSH, and is easily adapted to the clinical setting without requiring excessive constraints on sample handling or storage. The team used anonymous, residual blood samples from 59 healthy individuals, 31 males, and 28 females, with an age range 1 to 87 years, with a mean of 25 years.
Thymoma 9-Gene Signature Test Predicts Metastasis
A new test that predicts metastases could prove useful in the management of patients with thymoma, a rare epithelial tumor arising in the thymus gland. However, because fewer than 1000 cases of thymoma are diagnosed in the world each year, a prospective study to validate the test could be a long time coming. The 9-gene signature DecisionDX-Thymoma test, being marketed by Castle Biosciences, is more accurate than traditional staging methods for predicting 5- and 10-year metastasis-free survival, according to senior author Sunil Badve, MD, director of the translational genomics core and director of research immunohistochemistry at Indiana University School of Medicine in Indianapolis, and colleagues.
Potential for a Faster, Simpler Diagnosis for Fibromyalgia Using a Finger-Stick Blood Sample
Researchers have developed a reliable way to use a finger-stick blood sample to detect fibromyalgia syndrome, a complicated pain disorder that often is difficult to diagnose. "We've got really good evidence of a test that could be an important aid in the diagnosis of fibromyalgia patients," said Tony Buffington, professor of veterinary clinical sciences at The Ohio State University and senior author of the study. "We would like this to lead to an objective test for primary care doctors to use, which could produce a diagnosis as much as five years before it usually occurs. “Though an infrared microscope can be expensive, Buffington said the testing could be affordable if a central lab existed to run the samples. That the method can use dried blood samples makes this concept feasible because dried blood can be legally sent via U.S. mail, he noted.
A New Home-Based HPV Test Is Launched in SA
A new cervical cancer screening test looks set to revolutionise the way in which women are tested for this disease. UDoTest has recently released a new self-collection test for HPV, the virus which causes cervical cancer, which has received widespread acceptance from the medical industry, and is claimed to provide greater accuracy than conventional tests. It also provides the added appeal of enabling women to test themselves at home.
T Cells May Help Predict Acute Rejection of Kidney Grafts
The presence of CD8 T cells expressing high levels of CD45RC is associated with increased risk of acute rejection of kidney allografts, researchers from France report. To test if this could be used as a biomarker for graft rejection in humans, Dr. Abdelhadi Saoudi from Inserm in Toulouse and colleagues retrospectively studied 89 patients who received a first kidney transplant obtained from deceased donors. The proportions of CD45RC in CD8 T cells strongly predicted acute rejection, whereas the proportions in CD4 T cells did not.
From Gold, a New Way to Control Blood Clotting
Using gold nanoparticles, MIT researchers have devised a new way to turn blood clotting on and off. The particles, which are controlled by infrared laser light, could help doctors control blood clotting in patients undergoing surgery, or promote wound healing. Currently, the only way doctors can manage blood clotting is by administering blood thinners such as heparin. This reduces clotting, but there is no way to counteract the effects of heparin and other blood thinners.
Newborn Screening at a Crossroads
Few programs in modern laboratory medicine can boast so much success at so little relative cost as newborn screening. This year marks the 50th anniversary of newborn screening in the U.S., a program that originally looked for just one disorder, phenylketonuria (PKU). The filter paper cards developed to capture small blood samples from infant heel pricks still bear the name of Robert Guthrie, MD, PhD, who invented the bacterial inhibition assay for PKU and championed widespread screening for the condition beginning in 1963. Today, state public health labs screen some 4 million babies in the U.S. every year for more than 50 disorders, and approximately one in every 300 newborns has a condition that can be detected through screening. However, even as public health laboratories are grappling with the promise of new technology such as tandem mass spectrometry and next generation sequencing, both laboratorians and public health advocates are alarmed that Congress may allow newborn screening legislation to expire later this year.
Progress Toward Standardization
In the past decade, interest in the steroid hormone vitamin D has soared as researchers have uncovered links between vitamin D and conditions such as heart disease, diabetes, rheumatoid arthritis, multiple sclerosis, Parkinson’s disease, and some cancers. With the news of the connection to these highly prevalent diseases, clinical laboratories quickly experienced a surge in demand for vitamin D testing. Not surprisingly, in vitro diagnostic manufacturers responded by introducing a number of new immunoassays for measuring 25-hydroxyvitamin D. Such assays offer laboratories a means to automate testing in order to meet the increased demand. Laboratories also have developed their own methods, such as liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS), to measure vitamin D. However, as test results accumulated, clinical laboratory professionals observed that vitamin D assays from different commercial sources and platforms produced inconsistent results from the same patient specimen. In some instances, these differences were large enough to affect whether a patient would be classified as having sufficient or deficient vitamin D levels. To correct these disparities, the Vitamin D Standardization Program (VDSP), an initiative of the National Institutes of Health Office of Dietary Supplements (NIH ODS), was launched in 2010 in collaboration with the National Institutes of Health, the Centers for Disease Control and Prevention (CDC), the National Institute for Standards and Technology (NIST), and Ghent University in Belgium.
AHRQ-Supported Conference Will Explore Diagnostic Errors
Diagnostic errors—defined as missed, delayed or incorrect diagnoses—account for significant harm to patients but are underemphasized and understudied. The AHRQ-supported Diagnostic Error in Medicine (DEM) 6th International Conference, to be held September 22 to 25 in Chicago, will explore ways to define, measure and reduce diagnostic errors. The DEM Conference is dedicated solely to the problem of diagnostic error, bringing together stakeholders with a shared goal of improving patient safety.
Beckman Coulter Life Sciences Buys Assets of ReaMetrix India
Beckman Coulter Life Sciences has purchased the flow cytometry business assets of a Bangalore-based life science technology company, ReaMetrix India. Besides providing Beckman Coulter Life Sciences with temperature-stable, single-dose, multi-color antibody cocktails targeting the HIV monitoring and clinical research markets, the transaction complement the company's flow cytometry portfolio with reagents.
Quest Diagnostics and the New York Giants
Quest Diagnostics and the New York Giants are teaming up to find new ways to use laboratory diagnostic information services to improve the health and performance of athletes of all ages and abilities through a new collaboration. In a release, the company noted that the partnership was announced at the Giants' headquarters and training facility at the MetLife Sports Complex. The Giants headquarters and training facility is newly renamed as the Quest Diagnostics Training Center.
China Bird Flu Appears to Have Spread From Person to Person
Single reported case does not mean pandemic is likely, although vigilance is needed, experts say
The first reported human-to-human transmission of the deadly H7N9 bird flu has occurred in eastern China. The illness first killed a 60-year-old man exposed to live poultry and then his previously healthy 32-year-old daughter who had been caring for him. But dozens of other people exposed to the two flu victims did not fall ill, according to a new report published Aug. 6 in the journal BMJ, leading epidemiologists to conclude that the virus's ability to transmit itself between humans is limited at this point. "To date, it hasn't been sustainable. It's only been one jump, from chickens to humans," said Dr. Marc-Alain Widdowson, who leads the international epidemiology and research team in the U.S. Centers for Disease Control and Prevention's Influenza Division. "It hasn't gone from chicken to human to human to human to human. That's the concern. That's when we have a pandemic on our hands."
Bird Flu Researchers Want to Create Deadly Virus in Lab
Researchers said they want to create a lab version of a deadly emerging bird flu in order to study a strain that might be more infectious to people. Responding to past concerns about such research, the U.S. government said it will require extra safety measures. The proposal still is controversial, with some researchers calling for the very highest level of security for labs pursuing the research. "The scientific justification presented for doing this work is very flimsy, to put it mildly, and the claims that it will lead to anything useful are lightweight," said Princeton's Adel Mahmoud in comments to Science. While U.S. research-funding agencies under the Department of Health and Human Services indicated they would review proposals to perform the infectivity research, Science also reported that prominent Chinese labs do not appear interested in such efforts.
Disruptions to Prenatal Gene Network Linked to Schizophrenia Development
Researchers have traced gene mutations found in people with schizophrenia to networks involved in fetal brain development, as they reported in Cell today. Schizophrenia, a highly heritable disease, has been linked to a number of individually rare genetic mutations. Patients with the sporadic, non-familial form of schizophrenia are especially likely to have de novo mutations behind their disease.
New Type of Protein Modification May Play a Role in Cancer and Diabetes
Scientists at The Scripps Research Institute (TSRI) have discovered a new type of chemical modification that affects numerous proteins within mammalian cells. The modification appears to work as a regulator of important cellular processes including the metabolism of glucose. Further study of this modification could provide insights into the causes of diabetes, cancer and other disorders. "It appears to be an intrinsic feedback mechanism in glucose metabolism, but I suspect that its other functions throughout the cell will prove at least as interesting when they are more fully elucidated," said Benjamin F. Cravatt, chair of the Department of Chemical Physiology and member of the Skaggs Institute for Chemical Physiology at TSRI. Cravatt and his postdoctoral fellow Raymond E. Moellering reported the finding in the August 2, 2013 issue of the journal Science.
Cancer Drug Resistance Mechanism Unraveled
Cancers that become resistant to an important class of drugs might be made vulnerable by tweaking the immune system, a team led by UCSD researcher Napolene Ferrara has found. A chemical called interleukin-17 involved in the immune response to infection promotes resistance to the drugs in lymphoma, lung and colon cancers, according to a study published in Nature Medicine. Ferrara was the paper’s senior author. Moreover, drugs already in clinical testing for other diseases block interleukin-17, Ferrara said. This means it might be possible to use these drugs to make these resistant cancers once again vulnerable to the antiangiogenesis drugs.
Stroke or Ear Infection? New Goggles Help Doctors Distinguish
Dizziness, vertigo and nausea are common symptoms of an inner-ear infection. But they can also be signs of a stroke. For doctors, especially those working in emergency rooms, quickly and accurately making the distinction is vital. But basic diagnostic tools, including the otoscope and simple eye-movement tests, are far from definitive. As a result, many doctors resort to a pricey imaging test such as a CT scan or an MRI. Nearly half of the 4 million people who visit U.S. emergency rooms each year with dizziness are given an MRI or CT scan, according to a study issued last month. Only about 3 percent of those 4 million people are actually having strokes. For the 25 percent of strokes that restrict blood flow to the back portions of the brain, CT scans are a poor diagnostic tool, according to the study’s leader, David Newman-Toker, an associate professor of neurology and otolaryngology at the Johns Hopkins University School of Medicine. “CT scans are so bad at detecting [these strokes] that they miss about 85 percent of them” in the first day after symptoms begin, he said. “That’s pretty close to useless.” Even MRIs miss almost 20 percent of strokes if the test is done within the first 24 hours. A new device offers a promising option for rooting out the cause of dizziness: eye-tracking goggles. The goggles have a motion sensor for the head and a high-speed camera that records eye movements. They connect to a laptop that analyzes how the head and each eye — the camera can record only one eye at a time — move in relation to each other.
Scientists Develop Tool to Analyze a Baby’s Cry for Health Disorders
We often wonder how moms are somehow able to tell the difference between a baby’s “I’m hungry” cry and “I have a poopy diaper” cry, but according to scientists at Brown University, subtle variations of a cry, that can be imperceptible to the human ear, can really hold important information about a baby’s health. Neurological or developmental defects can change the way infants control their vocal cords, thus affecting how a cry sounds (Cri du chat is one easily detectable example with symptoms similar to Down syndrome). To learn more about a baby’s health and look for possible neurological or developmental disorders, the scientists created a computer-based cry analyzer that detects the more subtle acoustical differences in an infant’s cry.
Ticks Confirmed to Harbor Heartland Virus, a Recently Discovered Disease in the U.S.
Scientists have for the first time traced a novel virus that infected two men from northwestern Missouri in 2009 to populations of ticks in the region, providing confirmation that lone star ticks are carrying the recently discovered virus and humans in the area are likely at risk of infection. The findings were published online in the American Journal of Tropical Medicine and Hygiene. Dubbed Heartland virus or HRTV, the infection causes fever, headaches, and low white blood cell and platelet counts. There is no treatment available for HRTV. Unlike other tick-borne diseases like Lyme, ehrlichiosis and Rocky Mountain spotted fever, HRTV is a virus and thus does not respond to antibiotics.
New Research Paves Way for Deadly Dengue Virus Treatments
New research into the fight against dengue may influence the development of anti-viral therapies that are effective against all four types of the virus. The findings, led by researchers at the University of Bristol, show for the first time that there may be significant differences in specific properties of the viral proteins for the four dengue virus types. New research into the fight against dengue may influence the development of anti-viral therapies that are effective against all four types of the virus. The findings, led by researchers at the University of Bristol, show for the first time that there may be significant differences in specific properties of the viral proteins for the four dengue virus types.
Breakthrough in Detecting DNA Mutations Could Help Treat Tuberculosis and Cancer
Modern genomics has shown that just one mutation can be the difference between successfully treating a disease and having it spread rampantly throughout the body. Now, researchers have developed a new method that can look at a specific segment of DNA and pinpoint a single mutation, which could help diagnose and treat diseases such as cancer and tuberculosis. These small changes can be the root of a disease or the reason some infectious diseases resist certain antibiotics. The findings were published online (July 28) in the journal Nature Chemistry. “We’ve really improved on previous approaches because our solution doesn’t require any complicated reactions or added enzymes, it just uses DNA,” said lead author Georg Seelig, a University of Washington assistant professor of electrical engineering and of computer science and engineering. “This means that the method is robust to changes in temperature and other environmental variables, making it well-suited for diagnostic applications in low-resource settings.”
Mechanism That Allows Bacteria to Infect Plants may Inspire Cure for Eye Disease
By borrowing a tool from bacteria that infect plants, scientists have developed a new approach to eliminate mutated DNA inside mitochondria—the energy factories within cells. Doctors might someday use the approach to treat a variety of mitochondrial diseases, including the degenerative eye disease Leber hereditary optic neuropathy (LHON). The research, published online in Nature Medicine, was funded by the National Eye Institute (NEI), a part of the National Institutes of Health.
As Climate, Disease Links Become Clearer, Study Highlights Need to Forecast Future Shifts
Climate change is affecting the spread of infectious diseases worldwide, according to an international team of leading disease ecologists, with serious impacts to human health and biodiversity conservation. Writing in the journal Science, they propose that modeling the way disease systems respond to climate variables could help public health officials and environmental managers predict and mitigate the spread of lethal diseases. The issue of climate change and disease has provoked intense debate over the past decade, particularly in the case of diseases that affect humans, according to the University of Georgia's Sonia Altizer, who is the study's lead author.
Lab-Grown Burger From Stem Cells Introduced: Looks Good, Tastes Blah
Scientists from the University of Maastricht in the Netherlands unveiled the first lab-produced burger, suggesting that the burgers of the future could be grown in laboratories rather than on cattle ranches. “Cows are inefficient, they require 100 grams of vegetable protein to produce only 15 grams of edible animal protein,” he told the Guardian newspaper, explaining how artificially grown meat was more efficient, “because we have all the variables under control. We don’t need to kill the cow and it doesn’t produce any methane.”
Race Matters When a Patient Needs a Stem Cell or Marrow Transplant
If you become ill with a blood cancer or other disease that requires a stem cell transplant, here’s an uncomfortable fact: Your race matters. Diversity is a strength in much of life, but it’s a curse when finding a stem cell donor match. For a successful transplant, donor and recipient must have nearly identical genes regulating certain immune cells. These genes evolved in response to the disease threats people faced long ago. “Tell me where your ancestors lived 500 years ago, and I’ll tell you who your potential donors are,” says Jeffrey Chell, an internist who leads the National Marrow Donor Program, also known as Be The Match.
FDA Warns of Fatal Skin Reactions With Acetaminophen
Acetaminophen is associated with rare but severe and sometimes fatal skin reactions at usual doses, the FDA said. The agency cited three published reports in which individuals developed Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), or acute generalized exanthematous pustulosis (AGEP) following administration of acetaminophen, and later showed skin reactions when rechallenged with the drug. The three cases of severe reactions confirmed with rechallenge involved two children and an elderly man who each had to be hospitalized.
Mercury may Be More Harmful Than Thought
More forms of mercury can be converted to deadly methylmercury than previously thought, according to a study published in Nature Geoscience. The discovery provides scientists with another piece of the mercury puzzle, bringing them one step closer to understanding the challenges associated with mercury cleanup. Earlier this year, a multidisciplinary team of researchers at Oak Ridge National Laboratory discovered two key genes that are essential for microbes to convert oxidized mercury to methylmercury, a neurotoxin that can penetrate skin and at high doses affect brain and muscle tissue, causing paralysis and brain damage. The discovery of how methylmercury is formed answered a question that had stumped scientists for decades, and the findings published this week build on that breakthrough. Mercury is a toxin that spreads around the globe mainly through the burning of coal, other industrial uses, and natural processes such as volcanic eruptions, and various forms of mercury are widely found in sediments and water. Methylmercury bioaccumulates in aquatic food chains, especially in large fish.
Healthcare Hit Hard by July Job Cuts
Job cuts in July ran deep in the healthcare industry due do the sequester and healthcare reform, according to the latest monthly job cut report released by Challenger, Gray & Christmas, Inc. The healthcare sector led July workforce reductions with 6,843 planned job cuts--the highest number of cuts in the industry since November 2009 when it slashed 9,558 jobs. According to the report, healthcare organizations have now cut 29,794 jobs this year, 59 percent more than the 18,770 planned job cuts announced by this point in 2012.
Hacker Magnet or Sophisticated Tool? Obamacare’s Database Debated
The Federal Data Services Hub, a $394 million contractor operation run by the Centers for Medicare and Medicaid Services in Columbia, Md., is a tool that will allow citizens applying for the new health insurance plans to enter their income and personal identification online and get a determination of eligibility for tax credits, in many cases within seconds. The hub is designed to link databases at HHS and IRS with the Homeland Security and Veterans Affairs departments, the Social Security Administration, the Office of Personnel Management and the Peace Corps. CMS Administrator Marilyn Tavenner said her agency is “hard at work designing and testing a secure system, and I can assure you that by Oct. 1, the health insurance markets will be open for business. I can also assure all Americans that the information they supply will be protected to the highest standards.”
Reform Update: Exchanges 'On Target' for Oct. 1, Sebelius Says
Health insurance exchanges in every state are set to go live in 18 weeks, and HHS Secretary Kathleen Sebelius promises that open enrollment will begin as scheduled. “We are on target and ready to flip the switch on Oct. 1,” Sebelius said during a conference call with reporters. Thirteen states, she noted, recently have announced that approved rates on the exchanges will be about 20% lower than previously estimated, and lower than what consumers were paying for comparable plans before. She explained how federal education and enrollment efforts are in a tricky period because officials want to raise awareness as much as possible but don't want to give the public the misimpression that they can sign up right now. While consumers can visit the government website, www.healthcare.gov, and create an account, it's still too early to do much else.
Fourth Big HIPAA Breach for OHSU
The Oregon Health & Science University has notified 3,044 patients that their protected health information has been compromised after several residents and physicians-in-training inappropriately used Google cloud services to maintain a spreadsheet of patient data. The Google cloud Internet-based service provider is not an OHSU business associate with a contractual agreement to use or store OHSU patient health information, according to officials. This is OHSU’s fourth big HIPAA breach since 2009 and third big breach just in the past two years, according to data from the Department of Health and Human Services. The data for the majority of the patients compromised included patient names, medical record numbers, ages, provider names, diagnoses and dates of service. For 731 of those patients, the data also included addresses.
Big Data Tying Knots in HIT Workforce
What health information technology professionals “really need is training in informatics,” said William Hersh, MD, chair of Oregon Health & Science University’s Department of Medical Informatics & Clinical Epidemiology. At hospitals and health systems across the country, EMR implementations, accountable care contacts and meaningful use are all driving a need for workers who can bridge the clinical and informatics gap — making clinicians’ lives easier, satisfying hospital administrators’ deadlines for regulatory compliance and helping the enterprise use its population health data better. The federal government’s health IT workforce development program at community colleges has had mixed successes — with some hospitals saying there wasn’t enough hands-on training, for instance, amid success stories, particularly among IT workers making forays into healthcare.
Patient Portal Mandate Triggers Anxiety
Stage 2 of the government’s Meaningful Use Program requires that at least 5 percent of patients view, download, and transmit their health information and send a secure electronic message to their provider. The CMS lowered this objective from 10 percent to 5 percent when it published its Stage 2 final rule. With the transition to Stage 2 starting in 2014, even the lowered objective spurred anxiety in the healthcare community over whether achieving the goal of patient engagement is even possible.
New Regulatory Agency in Africa Aims to Facilitate Approval of CD4 Diagnostic Tests
Noting the WHO [World Health Organization] has called for 15 million people living with HIV to be receiving antiretroviral therapy (ART) by 2015 and new WHO HIV treatment guidelines say ART should be prescribed when patients’ CD4 cell counts reach 500 cells/mm3, a higher threshold than previously recommended, The Guardian’s “Global Development Professionals Network” writes, “CD4 counts are therefore pivotal to reach the UNAIDS target, particularly in sub-Saharan Africa where HIV prevalence is high, but the test [to determine CD4 count] isn’t widely available in countries with poor health care.” While “[t]he introduction of decentralized point-of-care tests, which can be used in resource-constrained settings by low-skilled health workers, could significantly increase coverage … [t]he trouble is that such point-of-care diagnostics are something of a blind spot when it comes to regulation,” the newspaper adds. In a bid to fill that gap, Unitaid decided to grant $5m to the London School of Hygiene and Tropical Medicine to create a harmonised regulatory framework for diagnostics in Africa. http://www.theguardian.com/
Disclaimer- The information provided in this news digest is intended only to be general summary information. It does not represent the official position of the Centers for Disease Control and Prevention and is not intended to take the place of applicable laws or regulations.
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