LSPPPO|HEALTHCARE NEWS|August 8, 2013
Healthcare News
A Weekly Compilation of Clinical Laboratory and Related Information
from The Division of Laboratory Science and Standards
September 12 2013
News Highlights
Use of Proficiency Testing as a Tool to Improve Quality in Microbiology Laboratories
CLIA Requirements for Proficiency Testing: the Basics for Laboratory professionals
CDC Warns of Complacency on Global Health Issues
Cancer Gene Sequencing Raises New Medical Ethics Issues
Rapid Tests Show Promise in Drug-Resistant TB
FDA Clears IMDx Test for Flu, Respiratory Virus
Siemens Recalls Microbiology Testing Panels: FDA
Stem Cell Treatments Overtake Science
Work Group Suggests Limited Regulation of Health IT by FDA
Flu Shot Reminders Start Early This Year
Princeton Drug Royalties Spark Suit Over Tax Exemption
View Previous Issues - Healthcare News Archive
CDC Warns of Complacency on Global Health Issues
America is facing a “perfect storm of vulnerability” for exposure to infectious diseases, making public health efforts more important than ever, the head of the Centers for Disease Control and Prevention warned. “There is in some quarters a sense that public health is less and less relevant,” CDC Director Dr. Tom Frieden said during a luncheon at the National Press Club. “Public health is more needed than ever and has more potential than ever.” The successful fight against many infectious diseases can lead to a sense of complacency, Dr. Frieden warned. But the increasing interconnectedness of the world means America is always at risk of being affected by outbreaks in other nations. A lot of food and medication in the U.S. comes from outside its borders, he said, and it only takes one missed diagnosis to unleash an epidemic.
Source: http://www.washingtontimes.com/
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Use of Proficiency Testing as a Tool to Improve Quality in Microbiology Laboratories
Proficiency testing (PT) is a valuable tool for assessing laboratory performance and verifying the accuracy and reliability of test results. Participation is required by the Clinical Laboratory Improvement Amendments (CLIA) of 1988 for each of the microbiology subspecialties (bacteriology, mycobacteriology, mycology, parasitology, and virology), and the regulations include specific PT requirements for each subspecialty. To determine the use and perceived value of PT beyond meeting CLIA requirements, the Centers for Disease Control and Prevention funded a cooperative agreement with the Association of Public Health Laboratories to convene a series of focus groups to query laboratory professionals responsible for PT.
Proficiency testing (PT) is a means of external quality assessment that is one of the main facets of the CLIA quality system for non-waived testing. It is a valuable tool for assessing laboratory performance and verifying the accuracy and reliability of test results. CLIA mandates that all laboratories that perform certain non-waived testing participate in a PT program approved by CMS.
Microbiology laboratories conducting non-waived testing need to meet general PT requirements, which include the following:
Enroll in a CMS-approved PT program for each specialty and subspecialty for which testing is performed. A list of CMS- approved PT programs can be found online at http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/ptlist.pdf 
.
Analyze at least five PT samples per testing event.
Obtain an 80% correct score on each testing event to achieve satisfactory performance.
Perform satisfactorily on two out of three testing events for successful performance.
Test PT samples in the same manner as testing is performed for patient specimens.
Perform PT for the primary method, test system, or examination used for patient testing.
Do not send PT samples or portions of samples to another laboratory for analysis.
Source: http://www.sciencedirect.com/
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CLIA Requirements for Proficiency Testing: the Basics for Laboratory Professionals
Along with requirements for personnel qualifications and quality control testing, proficiency testing (PT) is one of the central safeguards of laboratory quality under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and its regulations. The CLIA regulations have often been compared to a three-legged stool, resting on requirements for personnel qualifications and two performance indicators: quality control testing and proficiency testing. Proficiency testing is the only external performance indicator required by CLIA.
To earn CEUs, visit www.mlo-online.com/ce
LEARNING OBJECTIVES
Upon completion of this article, the reader will be able to:
Describe CLIA proficiency testing (PT) requirements.
Describe PT scoring criteria and special conditions for some disciplines.
Identify approved PT accreditation agencies and program specialties available.
Define the terms for acceptable performance as outlined by CLIA.
Source: http://www.mlo-online.com/
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Cancer Gene Sequencing Raises New Medical Ethics Issues
Cancer researchers are routinely analyzing hundreds of individual cancer genomes in the quest for better, more personalized treatment. As a byproduct of this work, new genetic sequencing methods are identifying medically important genomic variants not related to the cancer under study (the "incidentalome"). This has created an unanticipated set of problems for researchers, clinicians, and patients. Researchers are wrestling with what to look for in genomic studies, how to handle the resulting information, and whether to contact patients for additional consent before genomic studies. Clinicians want to know more about what constitutes a "medically actionable" gene variant, how to respect patient autonomy without shirking ethical responsibility, and what to do about potential genetic discrimination and the threats to privacy posed by electronic medical records. Patients may not be sure how much of this information they want to know and may not have access to adequate genetic counseling, which is not usually covered by insurance.
Source: http://www.medscape.com/
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Princeton Drug Royalties Spark Suit Over Tax Exemption
Edward C. Taylor’s fascination as a Princeton University chemistry professor with butterfly wing pigmentation led him to invent a compound that Eli Lilly & Co. (LLY) turned into the $2.5 billion-a-year cancer drug Alimta. Princeton, the fifth-richest U.S. University, patented Taylor’s invention, and the school reaped $524 million from 2005 to 2012 in license income, mostly from Lilly. The school used part of the money to build a new chemistry building and pay $118 million to faculty through 2011 beyond their salaries. Residents in Princeton, New Jersey, have sued the municipality and the university, saying the school should lose its tax-exempt status because it shares royalties with faculty. A state Tax Court judge refused to dismiss the case this summer and said it may have wide implications beyond Princeton.
Source: http://www.bloomberg.com/
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Artificial Intelligence in the Lab
Laboratory testing is usually regarded as being on the cutting edge. New technologies are constantly emerging in the field, and testing modalities are always improving, but there are still some advances that stand to change the nature of the clinical laboratory. Artificial intelligence (AI) and Machine Learning (ML) are trends that make it seems like science fiction is slowly becoming reality. Not only are these modalities on the horizon, but some of their results are already in use -- allowing for continued growth in the industry.
Source: http://laboratory-manager.advanceweb.com/
Elevated CRP May Be Associated With Increased Risk for Developing Schizophrenia
Elevated plasma levels of the inflammatory molecule C-reactive protein (CRP) may be a marker of an increased risk for developing schizophrenia, a study suggests. The research team says that these “novel findings” are in line with a previous report that patients hospitalized with autoimmune disease or severe infection (i.e., conditions associated with elevated inflammation) had an increased risk for later schizophrenia. However, Børge Nordestgaard (Copenhagen University Hospital, Denmark) and co-workers note that all 78,810 participants in their population-based study were at least 20 years old, so the postulated association may only apply to late-onset schizophrenia.
Source: http://www.medwirenews.com/
Genetic Test May Improve Colon Cancer Screening
A highly sensitive way of detecting mutations that kick-start colon cancer could be used to find disease earlier and in a noninvasive manner, researchers reported. In a small study, the method was able to detect mutations in two genes involved in initiating colon cancer despite the presence of large amounts of normal DNA, according to Bettina Scholtka, PhD, of University of Potsdam in Nuthetal, Germany, and colleagues.
Source: http://www.medpagetoday.com/
Blood Test IDs Acute Kidney Injury in ED
A test that measures blood levels of neutrophil gelatinase-associated lipocalin (NGAL) accurately distinguished between acute kidney injury and reversible transient kidney dysfunction in the ED, researchers reported. Among 616 patients with varying urgent health issues presenting to a hospital emergency department, the highest median levels of plasma NGAL were seen in those with acute kidney injury (146-174 ng/ml at various time points); levels also increased with acute kidney injury (AKI) severity (207-244 ng/ml for AKI Network stage 2 or greater disease).
Source: http://www.medpagetoday.com/
Cystatin C Hones Prediction of Renal Function
The association between estimated glomerular filtration rate (eGFR) and both death and end-stage renal disease (ESRD) strengthened significantly when cystatin C measurement was added to creatinine assessment, a meta-analysis showed. In general-population cohorts, the proportion of people with eGFR Source: http://www.medpagetoday.com/
Rapid Tests Show Promise in Drug-Resistant TB
A trio of tests for extensively drug-resistant tuberculosis (TB) were deemed fast and accurate, returning results within a week in some cases, researchers reported. Based on an interim analysis, the Line Probe Assay (LPA) took about 1 to 2 days to return a clinically meaningful result, while the Microscopic Identification of Drug Susceptibility (MODS) test produced results in about 5 to 7 days, according to Antonino Catanzaro, MD, from the University of California San Diego, and colleagues. In comparison, the gold standard for TB testing, MGIT 960 (Mycobacteria Growth Indicator Tube test) required a median of 25 days to identify extensively drug-resistant TB, he explained during a press briefing at the European Respiratory Society (ESR) meeting. The third test, pyrosequencing (PSQ), was able to produce results in one day in some instances, but in other cases, took over 200 days, he added. Although the study is ongoing, Catanzaro told MedPage Today that the MODS and LPA tests are ready for prime time in areas of the world where extensively drug-resistant TB is common. He added that the pyrosequencing test might eventually be a better test, but was technically difficult to use at the moment. The development of the quicker tests for extensively drug-resistant TB was mandated by the World Health Organization (WHO).
Source: http://www.medpagetoday.com/
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Standard Tuberculosis Skin Test Could Be Replaced by Microneedle Patch
Each year, millions of people in the United States get a tuberculosis skin test to see if they have the infection that still affects one-third of the world's population. But the standard diagnostic test is difficult to give, because a hypodermic needle must be inserted at a precise angle and depth in the arm to successfully check for tuberculosis. Now, a team led by University of Washington engineers has created a patch with tiny, biodegradable needles that can penetrate the skin and precisely deliver a tuberculosis test. The researchers published their results online in the journal Advanced Healthcare Materials. "With a microneedle test there's little room for user error, because the depth of delivery is determined by the microneedle length rather than the needle-insertion angle," said senior author Marco Rolandi, a UW assistant professor of materials science and engineering. The researchers will continue developing the microneedle tuberculosis test and plan to test it next on humans. They also hope to develop different diagnostic tests using microneedles, including allergy tests.
Source: http://www.medicalnewstoday.com/
'Nose Knows' Devices Not Ready for Clinic
In a presentation at the European Respiratory Society congress, Maris Bukovskis, MD, lecturer in medicine at the University of Latvia, Riga, described preliminary findings in which the electronic nose was able to correctly identify 128 or 140 cases of lung cancer in nonsmokers – a positive predictive value of 91.4%; and was able to determine there was no cancer in 120 of 125 healthy volunteers, a negative predictive value of 96%.In smokers, the experimental electronic nose picked up 114 lung cancers and missed seven for a positive predictive value of 94.2%; and ruled out cancer in 84 of 89 healthy individuals for a negative predictive value of 94.4%. "These are good findings," Bukovskis said at an ERS press briefing, "but we need to improve on them." "We still have work to do with this device to prevent false positives and false negatives," Immanuels Taivans, MD, professor of medicine at the University of Latvia, told MedPage Today at poster presentations describing the studies.
Source: http://www.medpagetoday.com/
Blood Test Provides Tool Essential to Trials of Therapies for Huntington's Disease
An assay designed to measure normal and abnormal forms of the huntingtin protein - the mutated form of which causes Huntington's disease (HD) - was successful in detecting levels of the mutant protein in a large multicenter study of individuals at risk for the devastating neurological disorder. The report from a team of Massachusetts General Hospital (MGH) investigators - which will appear in the Sept. 24 issue of Neurology and has been released online - also found changes in levels of the mutated protein that might predict when symptoms will appear.
Source: http://www.medicalnewstoday.com/
Microarray-based Gene Expression Profiling Reveals 3 Subtypes of Gastric Cancer
Stomach cancer, one of the leading causes of cancer death worldwide, actually falls into three broad subtypes that respond differently to currently available therapies, according to researchers at Duke-NUS Graduate Medical School Singapore. The finding could greatly improve patient care with the development of a genetic test to classify tumors and match them to the therapies that offer the best outcomes. "One of the features that makes gastric cancer so lethal is that it arises from many genetic alterations, creating differences in how the tumors respond to therapies," said Steve Rozen, Ph.D., director of the Centre for Computational Biology at Duke-NUS. Rozen is senior author of the study published in the September issue of the journal Gastroenterology. "What our study has shown is that there are actually three distinct molecular classifications that appear to be biologically and therapeutically meaningful."
Source: http://www.medicalnewstoday.com/
Genetic Test May Improve Colon Cancer Screening
A highly sensitive way of detecting mutations that kick-start colon cancer could be used to find disease earlier and in a noninvasive manner, researchers reported. In a small study, the method was able to detect mutations in two genes involved in initiating colon cancer despite the presence of large amounts of normal DNA, according to Bettina Scholtka, PhD, of University of Potsdam in Nuthetal, Germany, and colleagues.
Source: http://www.medpagetoday.com/
FDA Clears IMDx Test for Flu, Respiratory Virus
Molecular diagnostic firm IntelligentMDx announced its flu and respiratory virus test has been cleared by the US Food and Drug Administration for marketing in the US. The FDA cleared IMDx's automated molecular diagnostic test for the detection of influenza A, influenza B, and respiratory syncytial virus directly from nasopharyngeal swabs from patients who exhibit symptoms of respiratory infection. The test is for use on Abbott's automated m2000 platform.
Source: http://www.genomeweb.com/
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Three States OK Saladax to Offer MyCare Tests
Saladax Biomedical said that its Saladax Biomedical Laboratories division has received licenses from three states allowing it to provide its MyCare tests to clinicians in those states. The licenses were granted by regulators in California, Rhode Island, and Maryland. Saladax was certified as a registered CLIA lab at its Bethlehem, Pa., facilities in June, allowing it to start clinical laboratory operations for the MyCare portfolio of products throughout most of the US. In addition to CLIA certification, however, a handful of states require licensures by their regulators in order for a company to offer its testing products and services.
Source: http://www.genomeweb.com/
Siemens Recalls Microbiology Testing Panels: FDA
Germany's Siemens recalled 78,020 microbiology testing panels in the United States as they are reporting false results, U.S. health regulators said. The defect found in certain MicroScan panels may lead to treatment of patients with inappropriate antibiotics or to a delay in the therapy they need, the U.S. Food and Drug Administration said on its website.
Source: http://www.reuters.com/
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FDA Issues Warning Letter to Agilent's Dako
The US Food and Drug Administration issued a warning letter to Agilent Technologies' Dako business, saying the company's HER2 chromogenic in situ hybridization, or CISH, pharmDx test and other products do not conform to federal current good manufacturing practice requirements. In a letter dated Aug. 21, the agency said that it found the problems during an inspection of Dako's facility in Glostrup, Denmark in March.
Source: http://www.genomeweb.com/
Myriad's Decisive Test Now Available
Recently, Myriad Genetics Inc. launched its major pipeline product myRisk Hereditary Cancer. The company’s latest offering is a multi-gene diagnostic test to analyze 25 genes related with eight major cancers – breast, ovarian, prostate, colorectal, endometrial, gastric, pancreatic and melanoma. In order to boost acceptance of the novel test, Myriad plans to demonstrate positive clinical validity data on myRisk Hereditary Cancer diagnostic test at The Collaborative Group of the Americas’ annual meeting on Inherited Colorectal Cancer (CGA) in October and the San Antonio Breast Cancer Symposium later in December. Myriad expects to keep the list price of myRisk Hereditary Cancer test in the range of $4,000−$4,500. The test has an estimated gross margin of about 87%.
Source:http://www.zacks.com/
NanoString Gets FDA OK for Breast Cancer Assay
NanoString Technologies said that the US Food and Drug Administration has granted 510(k) clearance of the firm's Prosigna Breast Cancer Prognostic Gene Signature Assay. The assay is based on the PAM50 gene signature and analyzes the gene expression profile of cells found in breast cancer tissue to assess a patient's risk of distant recurrence of disease. Prosigna is NanoString's first FDA-cleared product and runs on the firm's nCounter Dx Analysis System. The assay is intended for use as a prognostic indicator for distant recurrence-free survival at 10 years. It is indicated for postmenopausal women with Stage I/II lymph node-negative or Stage II lymph node-positive hormone receptor-positive breast cancer who have undergone surgery in conjunction with locoregional treatment consistent with standard of care, said NanoString.
Source: http://www.genomeweb.com/
Theranos Selects Walgreens as a Long-Term Partner Through Which to Offer Its New Clinical Laboratory Service
Theranos, Inc. and Walgreens announced a long-term partnership to bring access to Theranos’ new lab testing service through Walgreens pharmacies nationwide. As the service becomes available through Theranos Wellness Centers inside Walgreens stores, consumers will be able to access less invasive and more affordable clinician-directed lab testing, from a blood sample as small as a few drops, or 1/1,000 the size of a typical blood draw. The samples are either taken from a tiny finger stick or a micro-sample taken from traditional methods, eliminating the need for larger needles and numerous vials of blood required for most diagnostic lab testing.
Source: http://convergence.llesiant.com/
BioMerieux to Acquire BioFire Diagnostics for $450M
French diagnostics firm bioMerieux made a big play, announcing an agreement to acquire privately held Salt Lake City-based BioFire Diagnostics for $450 million plus debt. BioFire specializes in molecular biology. Specifically, the company manufactures and commercializes PCR FilmArray, a system to aid in diagnosing infectious diseases. BioMerieux, which bases its U.S. operations in Durham, hopes BioFire will generate $70 million in sales in 2013, including $40 million from the FilmArray platform alone.
Source: http://www.bizjournals.com/
MuirLab Being Sold, Hundreds Facing Layoffs
It could be the largest layoff of its kind in Contra Costa County in an industry that is otherwise growing. John Muir Health has announced it is selling off its outpatient labs. MuirLab serves Contra Costa, Alameda and Solano counties. Hundreds of employees could lose their jobs. John Muir Health has sold MuirLab to LabCorp, which already has a large presence in the East Bay.
Source: http://abclocal.go.com/
FDA Green Lights New Products of Atlanta Companies
A number of new medical products developed by metro Atlanta companies have just received a green light from the U.S. Food and Drug Administration.
Kimberly-Clark Corp. of Roswell, Ga., got the go ahead to market its Kimvent Microcuff Subglottic Suctioning Endotracheal Tube. Kimberly-Clark has a 98-acre campus in Roswell that's home to its Global Health Care, Kimberly-Clark Professional and Global Non-Wovens business sectors. Click here to learn more.
Another Roswell, Ga., company, Opti Medical Systems Inc., was cleared to market its Opti CCA-TS2, a device for measuring blood gases and blood acidity.
Fertility Focus Ltd. of Suwanee, Ga., got the FDA's okay to market its Ovusense advanced fertility monitoring system.
The FDA approved Southern Spine LLC of Alpharetta, Ga., to market its C-Fuse Cervical Intervertebral Body Fusion System.
And Endochoice Inc., also of Alpharetta, was okayed to market its Autoband Ligator, a device used in gastroenterology and urology.
Source: http://www.bizjournals.com/
Invitae Announces Results of Hereditary Breast Cancer Study in Collaboration With Stanford University
Presentation at ASCO Breast Symposium demonstrates that next-generation DNA sequencing technology accurately identifies BRCA 1 and 2 mutations and multi-gene testing adds value beyond BRCA 1 and 2 for cancer patients
Invitae, Inc., a genetic information company, announced the results of a study conducted in collaboration with Stanford University assessing hereditary breast and ovarian cancer risk using a multi-gene next-generation sequencing panel. The results showed that analysis of BRCA1/2 mutations produced results concordant with prior clinical testing and also identified additional pathogenic variants in genes other than BRCA1/2. The study was presented by Allison Kurian, M.D., assistant professor of Medicine (Oncology) and Health, Research and Prevention and the associate director of the Breast Cancer Genetics Clinic at Stanford, during the Poster Discussion Session A at the American Society of Clinical Oncology (ASCO) Breast Symposium, September 7, 2013 in San Francisco, CA.
Source: http://www.tm-partners.com/
NIH Grants Expand Search for Role of Microbes in Health and Disease in Adults, Infants
People are host to trillions of microbes living on their skin and in the gut, vagina, mouth, nose, lungs, and penis. These microbes live as communities in and on the human body and are known as the human microbiome. For the most part, we peacefully co-exist with these microbes. But sometimes some of these microorganisms such as bacteria can trigger responses that may cause people to develop a disease. To better understand how and why alteration of the normal microbiome at various body sites promotes diseases, the National Institutes of Health will fund three innovative research projects for the next three years. These projects constitute the second phase of the Human Microbiome Project (HMP), begun in 2007. The first phase of the HMP focused on the composition and genetic potential of the microbial communities of major regions of the body and how these communities differ in health and for various diseases. The second phase will focus on measuring the biochemical activities of these communities, activities which hold the key to how microbes influence the physiology of the human host within which they reside.
Source: http://www.nih.gov/
Study Suggests Early Signs of MS in Spinal Fluid
New research suggests it might be possible to spot early signs of multiple sclerosis in patients' spinal fluid, findings that offer a new clue about how this mysterious disease forms. The study released was small and must be verified by additional research. But if it pans out, the finding suggests scientists should take a closer look at a different part of the brain than is usually linked to MS. "It really tells us that MS may be affecting more parts of the brain much earlier than we anticipated," said Timothy Coetzee, chief research officer at the National MS Society. Coetzee wasn't involved with the new study.
Source: http://www.lasvegassun.com/
With Safeguards, Iron May Not Raise Kids' Malaria Risk
Despite concerns that iron supplements may increase children's risk of malaria in regions where it is common, a new study found kids in Ghana who received nutrient powder with iron were no more likely to get the disease than their peers. According the World Health Organization (WHO), there were approximately 660,000 deaths from malaria in 2010. About 90 percent of those occurred in Africa, most in children under five years old. Some studies have suggested giving children iron might increase their risk of malaria - including one trial that was halted early due to more hospitalizations for malaria and other infections among children receiving iron. The theory is that malaria-causing parasites can take up extra iron in the body before it binds to proteins, hastening parasites' growth and giving malaria a "head start," Dr. Stanley Zlotkin, from the Hospital for Sick Children in Toronto, said.
Source: http://www.reuters.com/
Hyperactivity Linked to Inner Ear Defect
When hyperactivity is found in children with severe hearing loss, it is often assumed to stem from frustrations they have communicating or socializing. But a new study says a genetic defect in the inner ear may also play a role in causing hyperactive behavior, suggesting that at least in some cases, hyperactivity can have a neurobiological root. Researchers at the Albert Einstein College of Medicine in the Bronx caused inner-ear defects in young mice by knocking out a gene called Slc12a2, causing a loss of hearing and sense of balance. But the removal of the gene also resulted in higher levels of two proteins, pERK and pCREB, in the striatum, a part of the brain that helps regulate motor functions. The mice then displayed hyperactive behavior, like running rapidly in a circle.
Source: http://www.nytimes.com/
More U.S. Patients Feared at Risk of Rare Brain Disease
Connecticut said that two patients who recently underwent surgery at a VA Hospital may have been exposed to a rare brain disease, adding to 13 people already reported at risk in Massachusetts and New Hampshire. The potential for exposure is believed to be the result of doctors using the same surgical instruments on several different patients. Those instruments were initially used on a New Hampshire patient, who has since died. That patient is now believed to have had a sporadic form of Creutzfeldt-Jakob disease, a condition similar to "mad cow" disease but not linked to beef consumption. Not every operating room keeps such specialty instruments on hand, and they can end up in different states if they've been leased from medical supply companies.
Source: http://www.reuters.com/
Drug Cocktail That Protects Monkeys From Deadly Virus May Aid Humans
A combination of two well-known antiviral drugs protects monkeys against MERS and could potentially be used to save humans from the lethal disease, scientists said. Researchers at the National Institute of Allergy and Infectious Diseases gave the drugs, ribavirin and interferon, to half of six rhesus monkeys eight hours after they were infected with the virus, now known as Middle East Respiratory Syndrome coronavirus. The three that got the two-drug cocktail had less virus in their blood, no breathing difficulties and only minimal X-ray evidence of pneumonia, while the untreated animals became very ill, said the authors of the study published by Nature Medicine. Dr. Anthony S. Fauci, the institute’s director, called the study “not a game changer, but an important observation.”
Source: http://www.nytimes.com/
Stem Cell Treatments Overtake Science
The rise of an international industry catering to customers who may pay tens of thousands of dollars in cash for their shot at a personal miracle. (Some foreign operators offer creative variations on the theme, like cells from sharks and sheep.) Domestic providers, too, can push the limits. In July, for example, a former pathologist at the Medical University of South Carolina pleaded guilty to illegally processing and shipping stem cells for treatment without approval from the university or the Food and Drug Administration. The number of clinics and products has reached the point that scientists fear repercussions for their own work. Dr. Hesham Sadek of the University of Texas Southwestern Medical Center in Dallas, who is studying heart muscle regeneration, worries that the marketing deluge now makes it hard for patients to tell science from swindle, and all that lies on the spectrum in between. “It really has the potential to undermine the legitimacy of the whole field,” he said.
Source: http://www.nytimes.com/
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E-Cigarettes 'as Effective' as Nicotine Patches
Electronic cigarettes appear to be at least as effective as nicotine patches in helping people to give up smoking, research suggests. The devices, which are rapidly growing in popularity, produce a vapour containing nicotine. The findings, presented at the European Respiratory Society, showed similar numbers quitting with e-cigarettes as patches, but more had cut down. There was a call, however, for long-term data on safety.
Source: http://www.bbc.co.uk/
Certain Bacteria May Help Ward Off Obesity
Bacteria in the human gut may play a key role in who is obese or lean and could lead to treatments for obesity, a study finds. The microorganisms in the human gut appear to play a pivotal role in determining whether a person is lean or obese, new research shows. The study, published online by the journal Science, is the strongest evidence yet that what's inside an individual's digestive tract influences the risk of obesity and its related health problems, such as Type 2 diabetes. The work helps explain the nation's 30-year run-up in excess weight — and it may supply a potential solution to the resulting epidemic, experts said.
Source: http://www.latimes.com/
Good Attitude Helps Heart to Heal
Ischemic heart disease patients who had positive attitudes were more likely to exercise and were less likely to die from any cause at 5-year follow-up, researchers found. High positive affect was associated with a significantly reduced risk of all-cause mortality (unadjusted hazard ratio 0.58, 95% CI 0.37-0.92) and a significant chance of exercising (unadjusted odds ratio 1.99, 95% CI 1.44-2.76) among 607 Danish ischemic heart disease patients, according to Susanne Pedersen, PhD, of Tilburg University in the Netherlands, and colleagues. Additionally, patients who exercised were 50% less likely to die by the 5-year follow-up (HR 0.50, 95% CI 0.31-0.8, P=0.004), they wrote online in Circulation Cardiovascular Quality Outcomes.
Source: http://www.medpagetoday.com/
U.S. Drinking Water Sanitation Still a Concern: CDC
Bacteria in plumbing systems, groundwater persist in causing outbreaks. While U.S. water sanitation has improved, bacteria-laden drinking water continues to cause disease outbreaks, according to a report released by federal health officials.Legionella-tainted plumbing systems, untreated groundwater, and problems with distribution systems were the three main culprits identified in the 33 outbreaks reported to the U.S. Centers for Disease Control and Prevention from 2009 to 2010.In all, unsanitary drinking water was responsible for 1,040 illnesses, 85 hospitalizations and nine deaths in 17 states during that time.
Source: http://consumer.healthday.com/
Flu Shot Reminders Start Early This Year
CDC starts shipping the vaccines; can’t predict severity of outbreak. Health officials said they have heightened awareness of the coming flu season and are stressing early action to avoid long lines and short supplies. “Last year you couldn’t find anything,” said Tony Raker, spokesman for the Inova Health System. “One of the messages that’s ingrained in people’s minds is that it’s too early. It’s not too early. If you don’t want to run out, now is the time to get your shot.” While the Centers for Disease Control and Prevention has begun shipping this season’s vaccines, officials would not offer a guess on the severity of this season because “flu seasons are highly unpredictable,” spokesman Jason McDonald said.
Source: http://www.washingtontimes.com/
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CDC Claims a Win for Anti-Smoking Ads
A 3-month advertising blitz sponsored by the CDC featuring "true stories told by former smokers" led some 220,000 current smokers to quit and about 1.4 million others to attempt cessation, CDC researchers said. Surveys of smokers conducted before and after the 2012 "Tips from Former Smokers" campaign indicated that cessation attempt rates increased by more than three percentage points, from 31.1% (95% CI 30.3%-31.9%) at baseline to 34.8% (95% CI 34.0%-35.7%) after the campaign, according to Tim McAfee, MD, of the CDC's Office on Smoking and Health, and colleagues.
Source: http://www.medpagetoday.com/
America's Fertility Rate Stabilizes After Years of Declines
The nation's fertility rate stabilized last year for the first time in five years, according to early data from the Centers for Disease Control and Prevention. That follows four years of big declines during the economic downturn that pushed the rate—the number of births per 1,000 women aged 15 to 44—to the lowest levels on record.
Source: http://online.wsj.com/
AHRQ Releases Physician Work Hours and Patient Safety Primer
The Agency for Healthcare Research and Quality's Patient Safety Network has released a primer on physician work hours and patient safety, detailing the Accreditation Council for Graduate Medical Education's 2010 recommendations for restructuring work shifts, training and oversight. The primer includes a review of the debate over physician hours, a variety of studies and articles on physician hours and patient safety.
Source: http://www.beckershospitalreview.com/
OIG: Medicare, RACs Botch Audits
Medicare's much criticized recovery audit contractors (RACs) may not be catching all overpaid claims and "high amounts of improper payment may continue," according to a government watchdog report. But, although RACs flagged half of all claims they reviewed as being improper in fiscal 2010 and 2011, the Centers for Medicare and Medicaid Services (CMS) didn't evaluate the effectiveness of those actions, the Health and Human Services' Office of the Inspector General (OIG) said. Therefore, it's difficult to know if the RACs' actions changed provider behavior. Furthermore, CMS hasn't taken action on referrals for potential fraud and hasn't evaluated the performance of all metrics in the RACs' contract, the report said.
Source: http://www.medpagetoday.com/
Docs Flock to Cloud to Save Bottom Line
Eighty-seven percent of all physician practices agree their billing and collections systems need upgrading, according to a new survey. The majority favor moving to a fully integrated practice management, EHR and medical software product, accessible through the cloud on any browser or device. The first of eight revenue cycle management studies to be released by Black Book, the "Top Physician Practice Management & Revenue Cycle Management: Ambulatory EHR Vendors," is an analysis of the convergence of the replacement EHR market with the needs of physician practices to upgrade patient billing processes. According to Black Book Rankings, the RCM software and services industry recently surpassed the $12 billion in the ambulatory physician practice segment due to demands encountered from reimbursement and payment reforms, accountable care participation, ICD-10 coding challenges and declining revenues.
Source: http://www.healthcareitnews.com/
Speech Recognition—How This Fits Into EHRs and MTs' Roles
Challenges included the following:
Some provider adoption and training issues
Time taken away from the patient care in the beginning
Decisions on mobility and devices to use for this technology and the EMR
Advantages:
Cost reduction in the long run
Provider acceptance and efficiency, ability to tell the patient's story, while capturing severity of illness
Reuse and templates developed for better documentation and CDI activities for revenue, quality, safety, regulatory data capture
Source: http://health-information.advanceweb.com/
3 Ways Small Hospitals Tackle IT Challenges
The "scope" of health IT issues faced by small and rural hospitals is relatively the same as that of bigger facilities, according to Stephen Stewart (pictured), CIO at 74-bed Mount Pleasant, Iowa-based Henry County Health Center. According to Stewart, there are three keys to maintaining success in a scaled-down environment like HCHC:
Measured goal setting:
Measured communication efforts:
Measured resource augmentation:
Source: http://www.fiercehealthit.com/
Work Group Suggests Limited Regulation of Health IT by FDA
Health information technology should not, as a general rule, be subject to pre-market regulation by the Food and Drug Administration as many medical devices are today, according to a work group giving advice to three federal regulatory agencies. The experts, however, carved out some exceptions to that broad recommendation, part of an ongoing look by the federal government into the patient safety implications of the expanding use of health information technology.
Source: http://www.modernhealthcare.com/
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HIT Policy Committee: Use Existing Regulation to Scrutinize Health IT
The HIT Policy Committee said there's no need for substantial new regulation of health IT, but closer scrutiny according to regulation already in place--with cross-agency collaboration, of course. It said technology should be assessed according to level of risk and it called for greater transparency in the process.
Source: http://www.fie