A Weekly Compilation of Clinical Laboratory and Related Information
from The Division of Laboratory Science and Standards
December 05, 2013
View Previous Issues - Healthcare News Archive
Clinical laboratories and hospitals and systems that own them say the CMS has failed to add enough nuance to the enforcement framework that protects its process for making sure that labs are proficient. In response to lobbying from the industry, Congress acted last year to give the CMS more discretion to determine when labs were intentionally undermining a system in which the CMS sends labs samples to test in the same manner they would test actual patient samples.
But the industry argues that the way the CMS has carried out that mandate still leaves them vulnerable to extreme penalties for minor and unintended infractions. The American Hospital Association said in a comment letter that the policy would have “a devastating impact on the patients served by large national health systems that often own and operate many laboratories in many locations.”
Lab and pathology groups are applauding a decision by the Centers for Medicare and Medicaid Services (CMS) to scrap a proposal to cap payment for certain anatomic pathology (AP) services provided by independent labs at Hospital Outpatient Prospective Payment System (HOPPS) levels. That proposal would have resulted in reductions of up to 80 percent for some common AP services. In the final Physician Fee Schedule rule for 2014, released late on Nov. 27, CMS said it is not finalizing that proposal and will consider more fully all comments received. The agency does expect to develop a revised proposal for using HOPPS and ambulatory surgical center rates in developing relative value units, which it will propose through further notice and comment rulemaking.
In a crackdown on genetic testing offered directly to consumers, the Food and Drug Administration is demanding that 23andMe immediately cease marketing its main DNA service until it receives marketing clearance from the agency. In a warning letter issued and posted on the F.D.A.'s website, the F.D.A. said that the company had failed to provide adequate evidence that its Personal Genome Service provided accurate results. “F.D.A. is concerned about the public health consequences of inaccurate results from the P.G.S. device,” the agency said in its letter. “The main purpose of compliance with F.D.A.'s regulatory requirements is to ensure the tests work.”
Harmonization Essential Following the Release of New Cholesterol Treatment Guidelines
AACC has released a position statement on harmonization of—or ensuring uniformity among—clinical laboratory test results to help patients receive appropriate diagnoses and medical treatment. With this statement, the association aims to raise awareness about this essential healthcare issue and urge the medical community to work together to make harmonization a reality. The few laboratory tests that have been harmonized to date, such as those for cholesterol, glucose, and hemoglobin A1c, have made a marked positive impact on diagnosis and treatment of heart disease and diabetes. In addition to improved patient care, harmonizing these tests may also lead to reductions in healthcare spending. As a striking example, the initiative to harmonize cholesterol tests only cost $1.7 million per year, while the health benefits it has yielded now save more than $338 million annually.
Results Reporting in Microbiology
What’s needed, what’s not?
After the patient specimens have been collected and the tests have been performed, after the legwork is complete and the results are in hand, reporting clinical microbiology findings should in theory be the easy part—the final step before an effective treatment plan is formed. But as any seasoned clinical microbiologist knows, that couldn’t be further from the truth. “There has always been an age-old challenge in what results the microbiology laboratory should report,” says David W. Craft, PhD D(ABMM), microbiology medical director at the Milton S. Hershey Medical Center and an associate professor of pathology at Pennsylvania State College of Medicine. “Unlike other departments in the clinical laboratory—hematology and chemistry, for example—we produce a lot of positive results that shouldn’t be acted on.” How test results are reported—and whether microbiology reports include commensal organisms or other information that may or may not be clinically significant—can have dramatic consequences for patient care. A test report can muddle the conversation about appropriate treatments, or it can save a patient’s life. And with the advent of new, high-throughput technologies, results that were difficult to report in the past have become even more challenging.
Short-Term Quality-of-Life Affected by Breast Biopsy
Breast biopsies can adversely affect short-term quality-of-life, and the effects are more pronounced in younger patients, according to a new study published online in the journal Radiology. More than 500,000 women in the United States have a breast biopsy each year. In the percutaneous method, a physician uses a needle to remove several small samples from the area of interest for pathological analysis. Percutaneous biopsies are associated with fewer complications than the surgical approach, but there are still significant short-term side effects, including pain and emotional distress.
New Study Helps Predict Life Expectancy in Healthy People Using Complete Blood Count Risk Score
Researchers at the Intermountain Medical Center Heart Institute in Murray, Utah, collaborated with scientists at Harvard’s Brigham and Women's Hospital in Boston on the new study using the complete blood count risk score, an inexpensive tool that uses all of the information in the common blood test that includes information frequently underused. Physicians have used this CBC lab test for years, but they did not understand that all of its components provide information about life expectancy, according to lead researcher, Benjamin Horne, PhD, director of cardiovascular and genetic epidemiology at the Intermountain Medical Center Heart Institute. When the Harvard team of researchers evaluated the Intermountain-derived CBC risk score among JUPITER trial participants, they found it to be a powerful tool to predict death. People with the highest CBC risk scores were about twice as likely to die as those with low scores, researchers found.
FDA Clears Bruker's MALDI Biotyper for Clinical Microbiology Use
The Food and Drug Administration has granted 510(k) clearance to Bruker's MALDI Biotyper CA system for identifying gram negative bacterial colonies cultured from human specimens, Bruker said. The MALDI Biotyper instrument uses proteomic fingerprinting to enable molecular identification and taxonomical classification of microorganisms including bacteria, yeasts, and fungi. They can be used in routine microbial identification, environmental and pharmaceutical analysis, taxonomical research, food and consumer safety and quality control, as well as in marine microbiology. The system includes the microflex MALDI-TOF mass spectrometer, software, IVD labeled reagents, a 48 spot MALDI target, and a library of microorganism reference spectra.
FDA approved the MiSeqDx genome sequencing system from Illumina Inc. the first high-throughput, next-generation genomic sequencer to be approved by the agency. The whole genome benchtop sequencer, which has been available for research-use only, is now approved in the U.S. for broad clinical use. In an article published in the New England Journal of Medicine, NIH Director Francis Collins and FDA Commissioner Margaret Hamburg said the approval of a non-disease specific sequencing platform will "expand the incorporation of genetic information into health care" and is a "significant step forward" in personalized medicine. However, the pair stressed the need to validate new genomic findings and said it is "critical" to extend FDA's oversight to laboratory-developed tests (LDTs) to "ensure the validation and quality" of the tests. Collins and Hamburg also said there should be "rigorous evidence" to support the use of genomic information in prescribing drugs, citing recent studies with vitamin K antagonists.
The nation’s leading heart organizations released a sweeping new set of guidelines for lowering cholesterol, along with an online calculator meant to help doctors assess risks and treatment options. But, in a major embarrassment to the health groups, the calculator appears to greatly overestimate risk, so much so that it could mistakenly suggest that millions more people are candidates for statin drugs. Dr. Sidney Smith, the executive chairman of the guideline committee, said the associations would examine the flaws found in the calculator and determine if changes were needed. “We need to see if the concerns raised are substantive,” he said in a telephone interview. “Do there need to be changes?”
Investigators Hone in on Aggressive Prostate Tumors
Investigators an ocean apart are proposing very different strategies for determining which prostate tumors are cause for worry and which can be pretty much left alone. Aggressive metastatic prostate cancer cells express high levels of the NAALADL2 (N-acetyl-L-aspartyl-L-glutamate peptidase-like 2) protein, which can serve as a diagnostic and prognostic biomarker for prostate cancer, report Hayley Whitaker, PhD, and colleagues at Cancer Research UK in Cambridge, United Kingdom. "This is early research, but if clinical trials confirm our results, it could help clinicians to tell which patients have a more aggressive tumor and need proportionally aggressive treatment, while sparing patients with low-grade tumors unnecessary radiotherapy or surgery," Dr. Whitaker said in a statement. The study was published online November 18 in Oncogene.
New Tests for Prostate Cancer
This last year has seen a surge of activity in researching and developing tests to help clinicians better diagnose and treat prostate cancer. Better tests are needed, many say, to more accurately detect prostate cancer and to help men and their physicians decide what to do about it. A few such tests have become commercially available recently or are poised to do so. But researchers warn that the tests need to pass muster before being adopted for use in the clinic. “They need to be proven,” said Scott A. Tomlins, M.D., Ph.D., assistant professor of pathology and urology at the University of Michigan at Ann Arbor. “This is an important consideration for clinicians to have: How much does this test improve their clinical decision making, and what will they do with the results of the test?”
The Medical Lab Implanted Under the Skin That Can Automatically Phone a Doctor Before You Fall Ill
A blood laboratory small enough to be implanted under the skin could revolutionise healthcare, researchers claimed. Measuring just 14mm long, it uses a mobile phone to send medical staff updates on a patient's health. The team at the École polytechnique fédérale de Lausanne say the gadget could be invaluable for patients undergoing chemotherapy, and could even warn of an impending heart attack by monitoring key chemicals in the bloodstream.
Diagnosing Sepsis More Quickly
A research team from bioMérieux reports the development of a new method that, they say, could cut hours off the time it takes to diagnose blood infections while also eliminating the need for complicated manual processing and expensive equipment. The technique combines a selective lysis step in which blood cells in the sample are destroyed, a centrifugation step to collect any bacteria or fungi in the sample, and a fluorescence step that analyzes the particular fingerprint of any pathogens present in the sample. Tests show the method correctly identifies the species of bacteria or fungi in 96.5% of positive blood culture samples, crucial information for doctors to provide the appropriate drugs for their patients.
Baby Tests Require a Culture of Safety
The nation's newborn screening system touches every one of the nearly 4 million babies born annually in the United States. It prevents death and disability through early identification of and interventions for newborns with numerous, but rare, disorders. This life-saving system requires a culture of safety that recognizes its complexity and proactively addresses its potential weaknesses. A culture of safety recognizes the complexity of the system, the absence of total safety, the ever-present vulnerability and the need to be vigilant at all times. A delay in screening, diagnosis or treatment can be the difference between life and death for some babies. For other infants, a delay can mean the difference between a healthy life or one with lifelong, serious disabilities and intellectual delays.
Children at Risk of AIDS Should be Tested at Birth – UN
More than a quarter of a million children each year are born infected with the virus that causes AIDS, but too few are being tested early to receive treatment and prolong their lives, the United Nations said. Michele Sidibe, executive director of UNAIDS, called for diagnostic kits to be improved for detection in babies of the Human Immunodeficiency Virus (HIV) that causes AIDS, and for their "still high" current price of $25-50 to be brought down. Children are the "forgotten" victims of the AIDS epidemic, yet 260,000 babies joined their ranks last year, mainly in sub-Saharan Africa, he said.
New ‘Smart Diaper’ Tests Baby’s Urine for Urinary Tract Infections, Dehydration, and Kidney Problems—Then Alerts Baby’s Doctor
Clever entrepreneur thinks up inventive way to truly do clinical laboratory tests at the ultimate point of care and use a smart phone application to alert the doctor. With the advent of digital technology and smartphones, medical laboratory testing is moving out of the central laboratory and into the bedside, homes and now into diapers! A new digital “Smart Diaper” invented by New York startup Pixie Scientific constantly monitor’s a baby’s health to detect urinary tract infections, kidney problems, or dehydration early, before the health issue escalates. ‘Smart Diaper’ Tweets When It Detects a Health Problem. The front of the smart diaper contains a panel of colored squares. Embedded into each square are dry reagents. These reagents are similar to the colored urine dipsticks patients commonly used in physicians’ offices, noted a story published on ABCNews.com.
First Molecular Test Developed to Diagnose Eosinophilic Esophagitis
The incidence of EoE has skyrocketed since it was first characterized two decades ago. The test, based on a 96 gene expression profile, "offers an unprecedented opportunity to improve diagnosis and treatment, and a platform approach for other inflammatory diseases," says Marc Rothenberg, MD, PhD, director of allergy and immunology at Cincinnati Children's and senior author of the study. Up to now, gene expression profiling has not yet been well applied to inflammatory diseases, he says. The study is published in the Dec. issue of the journal Gastroenterology.
A new genetic sequencing test moves beyond testing for one disease at a time, making it possible to identify more than 750 diseases triggered by mutations in children in one shot and deliver results within 6 to 8 weeks. The screening panel, called the Targeted Gene Sequencing and Custom Analysis (TaGSCAN), covers the 514 genetic regions that code for pediatric conditions with possible hereditary or elusive diagnoses, according to lead investigator of the team that developed the panel, Stephen Kingsmore, MB ChB DSc, director of the center for Pediatric Genomic Medicine at Children's Mercy in Kansas City.
University of Washington Bioengineers Discover Simple Technique to Use Ordinary Paper for Cheap Point-of-Care Medical Laboratory Tests
This technique transforms ordinary paper into a biofunctional medium that could support a variety of diagnostic tests and lower the cost of clinical laboratory testing Is the clinical laboratory profession ready for a diagnostic technology that uses ordinary copy paper as the foundation for applying the reagents needed to run any number of fast, portable, accurate, and cheap medical laboratory assays? A recent technology breakthrough may make this possible in just a few years. A bioengineering team at the University of Washington (UWA) has developed a method to stick medically interesting molecules to ordinary copy machine paper. This “chemical trick” opens the door to developing all sorts of paper-based diagnostic tests that are not just cheap, but virtually free, noted a report published by Fierce Medical Devices.
Abbott Issues Voluntary Recall of Certain FreeStyle® and FreeStyle Lite® Blood Glucose Test Strips in the United States
Abbott announced it is initiating a voluntary recall of 20 lots of FreeStyle® and FreeStyle Lite® Blood Glucose Test Strips in the United States. These lots of test strips may produce erroneously low blood glucose results when used with both "FreeStyle® Blood Glucose Meter" and "FreeStyle® Flash Blood Glucose Meter” [neither of which have been in production since 2010], as well as the OmniPod® Insulin Management System. The company is notifying healthcare professionals, pharmacies, distributors and customers about the recall; customers affected by this action are instructed to call Abbott's diabetes care customer service at 1-888-736-9869 for a replacement of the affected test strips at no charge.
Research May Lead to Blood Test to Detect Enlarged Aortas
When Dr. Hal Dietz arrived at Johns Hopkins University in the 1980s, he became obsessed with helping children with Marfan syndrome, a rare and often fatal disorder that can cause the aorta, the large blood vessel that carries blood from the heart, to grow and grow until it bursts. “I decided to study genetics with the sole incentive to identify the gene for Marfan syndrome and ultimately to understand the mechanism,” said Dr. Dietz, now director of the William S. Smilow Center for Marfan Syndrome Research at Johns Hopkins. That journey has led to surprising discoveries about Marfan’s causes and a soon-to-be published clinical trial of a drug that may help its sufferers. Dr. Dietz’s work also inspired research that may lead to a blood test that detects enlarged aortas, potentially saving thousands of lives, even among those who do not have Marfan syndrome.
New Tool Weighs Cancer Screening Strategy, Life Expectancy
Physicians may be better able to tailor cancer screening recommendations for elderly patients by using a new tool that estimates comorbidity-adjusted life expectancy, according to an article published online November 18 in the Annals of Internal Medicine. Even when using the tool, however, physicians still need to consider patient preferences when making such complex decisions, write Hyunsoon Cho, PhD, from the National Cancer Institute, Bethesda, Maryland, and colleagues. The investigators analyzed Medicare data on 407,749 elderly persons to develop tables that can be used to estimate life expectancies for patients who have or do not have comorbid conditions.
New Technology Developed in Belfast Will Accelerate Cancer Diagnostics and Drug Development
TissueMark analyses the detailed structural patterns in tissue samples and marks the boundaries of potentially cancerous sections for more detailed analysis. The new software will help accelerate cancer research and discovery, reduce time in drug development and to identify new markers of the disease. To date, this process has been carried out manually, with sections being hand-marked by pathologists on slides. An expert pathologist can mark around one hundred samples per day. TissueMark can do the same work in greater detail in ten minutes.
Cancer Risk Warning From Higher Than Normal Levels of Vitamin B12
Vitamin B12 (cobalamin [Cbl]) is essential for maintaining healthy bodily function but higher than normal levels (reference range 200-600 pmol/L) may indicate that a patient is at risk of developing certain cancers, according to a study published in the Journal of the National Cancer Institute. Previous studies had suggested an association between high Cbl levels and specific cancers.
Herpes Virus Tied to Pulmonary Fibrosis
Idiopathic pulmonary fibrosis (IPF), a fatal progressive lung disease, might be caused by a virus, researchers reported. Evidence of the pathogen, herpesvirus saimiri, was found in all tissue samples from a cohort of patients with IPF, but in none of those from patients with fibrosis with a known cause, according to Gerard Nuovo, MD, of Ohio State University Comprehensive Cancer Center in Marion, and colleagues. The finding might be useful in diagnosing IPF, a disease for which there is currently no diagnostic test, Nuovo and colleagues reported online in Modern Pathology
How Zinc Starves Lethal Bacteria to Stop Infection
Australian researchers have found that zinc can 'starve' one of the world's most deadly bacteria by preventing its uptake of an essential metal. The finding, by infectious disease researchers at the University of Adelaide and The University of Queensland, opens the way for further work to design antibacterial agents in the fight against Streptococcus pneumoniae. Published in the journal Nature Chemical Biology, the researchers describe how zinc "jams shut" a protein transporter in the bacteria so that it cannot take up manganese, an essential metal that Streptococcus pneumoniae needs to be able to invade and cause disease in humans.
Bone Density Higher in Blacks, Vitamin D Lower
Black Americans had lower levels of total 25-hydroxyvitamin D and vitamin D-binding protein than whites, but they had similar levels of bioavailable 25-hydroxyvitamin D and higher bone density, a population-based cohort study reported. The researchers measured levels of total 25-hydroxyvitamin D, vitamin D-binding protein, and parathyroid hormone, as well as BMD. They also genotyped the participants for two common polymorphisms in the vitamin D-binding protein gene. Levels of bioavailable 25-hydroxyvitamin D were based on estimates. The findings may be explained by variants in the vitamin D-binding protein gene, which often differ in those of African and European descent. When the researchers genotyped study participants, they found genetic polymorphisms that accounted for 79.4% of the variation in levels of vitamin D binding protein, and 9.9% of the variation in levels of vitamin D-binding protein and total 25-hydroxyvitamin D. "Low levels of vitamin D-binding protein in blacks may provide protection against the manifestations of vitamin D deficiency despite low levels of total 25-hydroxyvitamin D," the authors wrote.
Some Peanuts a Day Keep Cancer, CVD Away
Eating more nuts correlated with significantly lower mortality, both overall and for cancer, heart disease, and lung disease, according to data from follow-up in two large cohort studies. As the frequency of nut consumption increased, the mortality hazard decreased by 7% with weekly intake to 20% for daily nut consumption, as compared with people who did not eat nuts.
Harvard Yoga Scientists Find Proof of Meditation Benefit
Scientists are getting close to proving what yogis have held to be true for centuries -- yoga and meditation can ward off stress and disease. John Denninger, a psychiatrist at Harvard Medical School, is leading a five-year study on how the ancient practices affect genes and brain activity in the chronically stressed. His latest work follows a study he and others published earlier this year showing how so-called mind-body techniques can switch on and off some genes linked to stress and immune function While hundreds of studies have been conducted on the mental health benefits of yoga and meditation, they have tended to rely on blunt tools like participant questionnaires, as well as heart rate and blood pressure monitoring. Only recently have neuro-imaging and genomics technology used in Denninger’s latest studies allowed scientists to measure physiological changes in greater detail. “There is a true biological effect,” said Denninger, director of research at the Benson-Henry Institute for Mind Body Medicine at Massachusetts General Hospital, one of Harvard Medical School’s teaching hospitals.
Antiviral Drugs, Found to Curb Flu Deaths in Children, Fall in Use
The flu can lead to serious complications, even death, in children, but relatively few studies have assessed the effectiveness of antiviral treatments in young patients hospitalized with the infection. Now a large study, published in the journal Pediatrics, has found that prompt use of antiviral medications like Tamiflu or Relenza can save the lives of flu-stricken children in intensive care units — yet the drugs are being used less frequently than they once were. Researchers at the California Department of Public Health and the federal Centers for Disease Control and Prevention analyzed the medical records of nearly 800 children hospitalized with influenza in that state from April 2009 through September 2012. Six percent of the 653 children treated with drugs called neuraminidase inhibitors died, compared with 8 percent of 131 children who did not receive antiviral treatment.
Diabetes: Mouse Studies Point to Kinase as Treatment Target
Targeting a pathway that plays a major role in both hepatic glucose production and insulin sensitivity may eventually help treat type 2 diabetes, researchers reported. In a series of experiments in mice, researchers found that inhibition of the kinase CaMKII -- or even some of its downstream components -- lowered blood glucose and insulin levels, Ira Tabas, MD, PhD, of Columbia University Medical Center in New York City, and colleagues reported online in Cell Metabolism.
NIDA to Fund Addiction-related Gene Studies in Animal Models
The National Institute on Drug Abuse plans to fund research efforts to develop new methods for sequencing, mapping, and analyzing genomes of animals that have been bred to have traits related to addiction, with the aim of identifying gene variants that may be involved in addiction.
Severe MRSA infections have decreased by 54.2% in U.S. hospitals since 2005, according to a new report from the Centers for Disease Control and Prevention, suggesting efforts to combat the deadly superbug are working. Since 2005, the CDC has been tracking MRSA cases in nine cities across the United States. An estimated 80,400 invasive MRSA infections occurred in 2011, compared to about 111,200 in 2005, according to the public health organization. The results were published in one of the American Medical Association's scientific journals, JAMA Internal Medicine.
New, Aggressive HIV Strain Found in West Africa
Swedish researchers have identified a new strain of HIV recently discovered in West Africa, which progresses to AIDS more quickly, reports AFP. The A3/02 strain combines the two most common HIV strains in Guinea-Bissau and develops into AIDS within five years, up to two-and-a-half years faster than either of its parent strains, said Angelica Palm, one of the scientists behind the study published in the Journal of Infectious Diseases. This type of strain, a recombinant, appears when a person becomes infected by two different strains, allowing DNA to fuse and create a new one.
H1N1 Influenza Virus Killed 10 Times More Than Estimated in 2009
The 2009 H1N1 "swine flu" epidemic killed up to 203,000 people across the globe -- a death toll 10 times greater than initially estimated by the World Health Organization, researchers say. In a study published in the journal PLOS Medicine, epidemiologists used data on respiratory deaths in 20 nations to calculate a global mortality rate for the pandemic. Prior to this research, the WHO counted just 18,631 lab-confirmed cases of H1N1, a viral infection of the airways. "This study confirms that the H1N1 virus killed many more people globally than originally believed," read a statement from Lone Simonsen, a research professor in the Department of Global Health at George Washington University.
Many Children 'Slower Runners Than Their Parents Were'
Many children cannot run as fast as their parents could when they were young, a study of global fitness says. Experts say the work - being presented at the American Heart Association's annual meeting - suggests children's fitness levels may be declining. Researchers analysed data spanning 46 years and involving more than 25 million children in 28 countries. On average, children today run a mile 90 seconds slower than did their counterparts 30 years ago, they said.
CDC finds race, sex, education, location and wealth among key factors in these inequalities
Despite progress in some areas, health disparities remain for many Americans, health officials reported. These inequalities are related to income, education, sex, race, ethnicity, employment and sexual orientation, and they all affect Americans' health and well-being, according to the U.S. Centers for Disease Control and Prevention. "The purpose of the report is to highlight disparities in health that still exist in the country," said Dr. Chesley Richards, director of the CDC's Office of Public Health Scientific Services, which produced the report. "If you look at health in the country over the last 50 years, there has been a dramatic improvement in health," he said. "We have seen an increase in life expectancy in the last 20 or 30 years." Across the 29 categories in the report there has been improvement, but many disparities persist, Richards said. "For example, we have seen a decrease in tobacco use, but it's not even. In people who have lower educational status, the disparity has actually widened -- not improved," he said. "Although we have seen pretty dramatic improvement in health for the population overall, you really have to look at particular groups to see that there are still tremendous disparities in health outcomes," Richards said. The report is published in a Nov. 22 supplement to Morbidity and Mortality Weekly Report, a CDC publication.
With blood oozing from deep lacerations, the two patients arrived at California Pacific Medical Center’s tidy emergency room. Deepika Singh, 26, had gashed her knee at a backyard barbecue. Orla Roche, a rambunctious toddler on vacation with her family, had tumbled from a couch, splitting open her forehead on a table. On a quiet Saturday in May, nurses in blue scrubs quickly ushered the two patients into treatment rooms. The wounds were cleaned, numbed and mended in under an hour. “It was great — they had good DVDs, the staff couldn’t have been nicer,” said Emer Duffy, Orla’s mother. Then the bills arrived. Ms. Singh’s three stitches cost $2,229.11. Orla’s forehead was sealed with a dab of skin glue for $1,696. “When I first saw the charge, I said, ‘What could possibly have cost that much?’ ” recalled Ms. Singh. “They billed for everything, every pill.”
In a medical system notorious for opaque finances and inflated bills, nothing is more convoluted than hospital pricing, economists say. Hospital charges represent about a third of the $2.7 trillion annual United States health care bill, the biggest single segment, according to government statistics, and are the largest driver of medical inflation, a new study in The Journal of the American Medical Association found.
Obama Pledges Up to $5 Billion for Global AIDS Fund
President Obama pledged up to $5 billion in U.S. money over the next three years to the pre-eminent global program to combat AIDS on the condition that the rest of the international community pitches in $10 billion. Obama announced the pledge to the Global Fund to Fight AIDS, Tuberculosis and Malaria as the White House marked World AIDS Day. Donor communities were getting ready to begin meetings in Washington to discuss the three-year replenishment cycle of the fund.
Think parsing the growing amount of information in electronic health records is tough now? Just wait until genomic data starts showing up in EHRs. "The number of individual genetic tests is daunting," Peter Tarczy-Hornoch, MD, chair of the University of Washington's Department of Biomedical Informatics and Medical Education, said at the American Medical Informatics Association's annual symposium. Each needs "structure and storage." A fully sequenced and analyzed genome contains about a terabyte of information, Tarczy-Hornoch explained during a well-attended session on integrating genomic data into the EHR, creating unprecedented storage and interoperability issues. Asked about how to move around such large files, Christopher Chute, MD, founder of Mayo Clinic's Division of Biomedical Informatics, recommended just recording variants in the EHR, not the entire genome. "It's a kind of lossless compression," he said.
Linking Genes to Diseases by Sifting Through Electronic Medical Records
Since 2005, scientists have carried out more than 1,500 genome-wide association studies, discovering thousands of links between gene variants and various conditions. But these studies have only put a dent in the genome’s mysterious complexity. Many of the gene variants they have uncovered have only a tiny influence on the risk of getting a particular disease. And when scientists have replicated genome-wide association studies, some links between genes and diseases have faded away. A study published in Nature Biotechnology opens up a new way to search for these links: by turning genome-wide associations on their head. In the new approach — called phenome-wide association studies — scientists start with a gene variant and then search among thousands of conditions for a match. To find those matches, scientists comb through electronic medical records.
Analysis of Huge Data Sets Will Reshape Health Care
Insurers will soon reassess how they predict costs; patients will let doctors know what medications won't work with their particular genomes; and researchers will look at hospital records in real time to determine the cheapest, most effective ways to treat patients — all because of developments in what is known as big data. Driven by industry trends and the Affordable Care Act, the analysis of large sets of data, such as medication usage or hospital readmissions, has enabled health care providers and policymakers to make smarter decisions and predict future trends. Electronic medical records and decisions by governments and companies to share data have made for smarter decision-making that can save money and provide better care, experts say.
Contagious disease data have been reported by cities and states to the federal government at weekly intervals in the United States since 1888. Now those data are publicly available in a computerized format thanks to a project at the University of Pittsburgh. Willem G. van Panhuis, MD, PhD, from the University of Pittsburgh in Pennsylvania, and colleagues published their description of the database in the November 27 issue of the New England Journal of Medicine. The database includes all weekly surveillance reports from US cities and states published between 1888 and 2011. It includes 87,950,807 reported individual cases, each localized in space and time, extracted from 6500 tables.
Health IT Takes Hold Around the World
Every country, every government, every population is a participant in a global trial and error. Each one faces different circumstances and, therefore, approaches healthcare differently. But, as world health leaders see it, everyone can learn from others' struggles and successes to improve and simplify their respective strategies. Health information technology is at the core.
The five main challenges for developing an IT infrastructure, says Al-Shorbaji, are issues of standardization and interoperability, lack of national planning, lack of solid evidence, sustainability (as insufficient funding has limited the success of many eHealth projects), and lack of human resources. ICT, therefore, is a central component to any UHC strategy, as there needs to be a system in place that can collect and share data in the healthcare system. Finding the best route to a meaningful HIT system, though, is still being worked out around the world.
AHRQ Report Focuses on Improving Care for Those With Complex Health Care Needs Through Health IT
A new report from AHRQ found that providing patients and clinicians with information and support using health IT was effective in improving outcomes and quality. “Findings and Lessons from the Improving Management of Individuals with Complex Health Care Needs Through Health IT Grant Initiative” documents the findings of more than 10 research projects that investigated how health IT applications can support shared decisionmaking and communication during care transitions, and facilitate secure exchange of information across multiple settings of care. Multiple studies showed positive impacts on process, health and economic outcomes.
InVitae Countersues Myriad in Northern California District Court
InVitae has countersued Myriad Genetics in the US District Court for the Northern District of California seeking declaratory judgment that certain claims held by Myriad on BRCA1/2 and MUTYH genes are invalid and are not infringed by Invitae. The action is in response to a suit Myriad and several other assignees filed against InVitae last week in the US District Court for the District of Utah accusing the firm of infringing claims in 11 patents underlying Myriad's BRACAnalysis test for hereditary breast and ovarian cancer risk. To date, Myriad has sued five companies alleging such infringement.
Medical Technician Sentenced in Hepatitis C Outbreak
A medical technician was sentenced to 39 years in prison for infecting at least 45 hospital patients with hepatitis C by contaminating their syringes. The technician, David M. Kwiatkowski, 34, pleaded guilty in August to 16 federal charges, including tampering with a consumer product and obtaining controlled substances through fraud. Prosecutors said that while he was working as a traveling medical technician in several states, including New Hampshire, Kansas and Maryland, Mr. Kwiatkowski injected himself with syringes of fentanyl, a powerful painkiller, then filled them with saline and put them back into circulation for patients.
Staff, Visitors Sue Summerlin Hospital in TB Case
Eight employees, former patients and visitors have filed a negligence lawsuit seeking damages from a Las Vegas hospital where they say they were exposed to a woman and at least one newborn baby with tuberculosis. The civil lawsuit filed in state court alleges that administrators at the northwest Las Vegas facility failed to recognize and take basic precautions to diagnose the infected woman's contagious lung disease when she gave birth May 11 to premature twin daughters, and allowed the woman to continue visiting her babies after she was discharged. More than 400 people have been tested so far for tuberculosis, and testing is ongoing, the lawsuit said.
Researchers Suggest China Consider National Flu Vaccination Plan With Staggered Timing
China should tailor its influenza vaccination strategies to account for its three distinct flu regions, according to the first comprehensive study of the country’s flu patterns conducted by a research team of Chinese and American scientists. “This research suggests the need for staggered timing of vaccination in three broad epidemiological regions,” said Dr. Cecile Viboud, who co-authored the study with Fogarty colleagues and Chinese collaborators.
Salt in Medicines 'Poses a Health Risk'
Soluble painkillers used by millions of people in Britain could pose a health risk because they are high in salt, UK researchers are warning. Some formulations taken at maximum dose tip users over the recommended daily sodium intake for an adult, with potentially dangerous consequences, the study authors say. Their work in the BMJ looks at the outcomes for 1.2 million UK patients. It found a link between effervescent tablets and heart attacks and stroke.
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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