viernes, 10 de enero de 2014



Healthcare News

A Weekly Compilation of Clinical Laboratory and Related Information 
from The Division Of Laboratory Programs, Standards And Services


January 09, 2014

View Previous Issues - Healthcare News Archive

CDC’s Frieden Lists Top Five Health Priorities of 2014

As head of the Centers for Disease Control and Prevention, Thomas Frieden oversees an agency with the sprawling mission of reining in diseases in the United States and across the globe. From fighting food-borne illness outbreaks and influenza epidemics to educating people about the risks of obesity and smoking, the CDC’s work touches every corner of public health. Given that broad range of responsibilities, we asked Frieden about what he considers the top public health priorities for 2014. Below are five areas he said deserve special attention, and why each is important.
  1. Increasing human papilloma virus (HPV) vaccinations
  2. Fighting the growing problem of antibiotic resistance, which kills an estimated 23,000 Americans each year
  3. Reducing deaths attributable to prescription painkiller abuse and overdose
  4. Ending polio once and for all
  5. Defending against health threats that originate elsewhere in the world


FDA, CDC, and Tests Steer Flu Dx Into New Season

What Soren Kierkegaard said about life applies just as well to flu seasons: They are understood backwards, but they have to be lived forwards. They’re not easy to forecast. And perhaps that’s one reason why the Centers for Disease Control and Prevention has just announced a “Predict the Influenza Season Challenge,” offering $75,000 to the competitor who most successfully predicts the timing, peak, and intensity of the 2013–14 flu season using social media data. Nationally, the 2013–14 season has gotten off to a somewhat more typical start, says Daniel B. Jernigan, MD, MPH, deputy director of the CDC’s Influenza Division. Since 2007, based on Medicare claims data, the number of rapid influenza diagnostic tests (RIDTs) as well as PCR-based flu and respiratory virus testing continues to grow even during relatively mild flu seasons, according to Julie Villanueva, MD, acting chief of the CDC virus surveillance and diagnosis branch. “While the amount of influenza-like illness is variable for any given season, when we look at the amount of diagnostic testing that’s occurred, we can observe a substantial increase in recent years,” Dr. Villanueva said in a presentation at the Food and Drug Administration last June. With these trends, plus a pending proposal by the FDA to reclassify RIDTs as class II devices, and the introduction of faster molecular tests for flu viruses, Dr. Jernigan and other experts in influenza testing see new directions ahead for diagnostic testing of influenza. In 2010, the CDC initiated a strategy for improving the performance of the rapid antigen tests in conjunction with the FDA, the Joint Commission, the Association of Public Health Laboratories, and other partners. “We had three areas of focus,” Dr. Jernigan says. “Better guidance, better practice, and better tests.” 


Clinical Validation

A change in the rules
CMS has redefined the rules in the Recovery Audit Statement of Work (SOW), released September 2011, which officially introduced the term "clinical validation" and directs reviewers to question unsupported diagnoses and procedures. Clinical validation was a hot topic of discussion in many of the physician-lead presentations at AHIMA's Clinical Coding Community meeting in October. Physicians are very aware of the game changing decision that opens the gate for reviewers to question them on clinically unsupported diagnoses and procedures. In the SOW, CMS defines DRG validation Adobe PDF fileExternal Web Site Icon [p.23] as the process of reviewing physician documentation and determining whether the correct codes and sequencing were applied to the billing of the claim. A certified coder performs the DRG validation review and focuses on what is documented by the physician and determines if code assignments are consistent with official coding guidance. Clinical validation Adobe PDF fileExternal Web Site Icon[p.23] is defined as the process of clinical review of the case to see whether or not the patient truly possesses the conditions that were documented. A clinician performs the clinical validation review.


Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 260kb)

Historically, the FDA has not recommended different types of information in premarket submissions (510(k) s) for blood glucose meters used by medical professionals as compared to over-the-counter self-monitoring devices intended for use by lay users. However, it has become increasingly clear that these different use settings create distinct intended use populations with unique characteristics and device design requirements. The FDA believes that in making this distinction, each of the devices can be better designed to meet the needs of their intended use populations, thereby ensuring greater safety and efficacy. 


Dropping the Ball on Critical Value POC Glucose Results?

Prompt reporting of critical laboratory results is considered an important patient safety goal. But for one of the most commonly performed tests, point-of-care glucose, there has been limited information about how critical results are handled. A new CAP Q-Probes study finds there is a great deal of variability. In addition to having widely differing critical result cutoff values, many laboratories are not repeating critical POC glucose test results for verification despite the relative high rate of erroneous results on first measurement. Using data from 50 participating laboratories, the study, “Point-of-Care Glucose Critical Values,” evaluates the reliability of POC glucose results in the critical range as well as practices associated with notification. The study reports that while 92 percent of participants had a policy for repeat testing of critical POC glucose results, the median rate of critical values retested within 10 minutes was only 56 percent. Failing to repeat POC glucose tests with results in the critical range is not advisable, the study authors say. “Good laboratory practices should include repeating all critical POCG test results with verification criteria provided to test operators,” they write in their analysis of the data. 


AACC Calls for Uniformity in Lab Test Results, Harmonization Essential to Improving Patient Care

AACC has released a position statement on harmonization of clinical laboratory test results to help patients receive appropriate diagnoses and medical treatment. In this statement, the association provides guidance on how medical community stakeholders can help the efforts of the International Consortium for Harmonization of Clinical Laboratory Results, an oversight body formed by AACC to manage the worldwide harmonization endeavor. The few laboratory tests that have been standardized or harmonized to date, such as those for cholesterol, glucose, and hemoglobin A1c, have markedly improved diagnosis and treatment of heart disease and diabetes. Additionally, harmonizing these tests may reduce healthcare spending. As a striking example, the initiative to standardize cholesterol tests only cost $1.7 million per year, while the health benefits it has yielded now save more than $338 million annually. 
“Results of patient lab tests should be comparable regardless of the method used, the time they were analyzed, or the laboratory that produced them,” said AACC President Robert H. Christenson, PhD. “Especially in situations where doctors depend on several risk factors in addition to test results to make treatment decisions, there cannot be discrepancies between test results if they are to be useful within the context of a patient’s overall health and medical history.”


'Real-World' Data Needed for Breast Cancer Genetic Testing

Genomic diagnostic tools such as OncoType DX (Genomic Health, Inc), MammaPrint (Agendia), and Cancer-TYPE ID (bioTheranostics) may help personalize treatment of breast cancer and, as a result, improve outcomes and reduce costs. However, some insurers are reluctant to pay for such tests in the absence of "real-world data," as most research on the economic value of genetic testing in breast cancer has relied on modeling rather than translational research or data from clinical trials, according to a review published in the December 2014 issue of the American Journal of Managed Care.


New Finding has Major Implications for Genetic Testing as Researchers Learn That Greater Numbers of Humans Have Multiple Personal Genomes

New insights about personal genomes will give pathologists and clinical laboratory scientists different ways to use genetic tests in the screening, diagnosis, and treatment of disease. Here is a human genome curve ball for pathologists and clinical laboratory scientists engaged in genetic testing in their medical laboratories. New research indicates that a larger number of humans than was once believed may have more than one genome. This has implications for many medical and health issues. Until recently, scientists assumed that, as a rule, each individual had a unique genome. Conditions such as mosaicism and chimerism were considered a rarity.


Sports Drug Testing Laboratories

"Doping" is as old as sporting events themselves and can be defined as the attempted use of a prohibited substance or prohibited method with the intent of improving athletic performance. As early as 800 B.C., ancient Greek athletes and Roman gladiators ingested a combination of herbs, plants, and mushrooms to gain a competitive edge and mask pain. With the debut of the modern Olympic Games in 1896, the practice of doping rapidly spread and different classes of compounds were used depending on the sporting event. For instance, athletes took stimulants (cocaine and amphetamines) to improve performance in speed and endurance sports, whereas they used anabolic steroids to promote muscle mass in sports requiring strength and power. Drug testing was introduced at the Olympic Games in 1968, but had little impact on the practice of doping since the testing methods had poor analytical sensitivity that significantly reduced the window of detection. 


Quality and the Sendout Testing Department

Arguably the biggest patient safety category in referral testing is specimen handling. Specimen integrity is paramount in providing the clinician with a viable laboratory result. This starts with initial collection, which sometimes requires special tubes and/or handling by the phlebotomist, as well as specimen labeling and in some cases clinical information. Specimen handling concludes with packing specimens into shipping containers in such a way that prevents leakage and maintains appropriate temperature. Laboratorians may not think of sendout testing as particularly time-sensitive because sendouts are not available stat, but timing with these tests is critical for at least two reasons. First, many specimens degrade over time. Ambient specimens are most prone to degradation, but refrigerated specimens can also degrade. This is of particular concern in smaller or rural hospital laboratories, where courier pickups may occur only once a day or less. Even when specimen stability is adequate for initial testing, this may not be the case with all-too-common add-on requests. Due to degraded specimens, add-ons often require either redrawing the patient or running the test with a disclaimer, risking inaccurate results as well as denied reimbursement.


A New Test for Malaria, No Blood Required

Rice University researchers have developed a rapid malaria test that uses a laser pulse, eliminating the need to draw blood. The test has not yet been tried on humans with the disease, but in experiments with blood samples and mice, it detected malaria when only one red blood cell in a million was infected, with no false positives, the inventor said. The results were described in a study published online in Proceedings of the National Academy of Sciences. In theory, said the inventor, Dmitri O. Lapotko, a physicist who studied laser weapons in his native Belarus, the technology can be used in a device powered by a car battery and is rugged enough to work in dusty villages. With a fiber-optic probe attached to a finger or ear lobe, the device could screen one person every 20 seconds for less than 50 cents each. If that happened, it could revolutionize malaria diagnosis. Current rapid tests require a finger prick, take 15 minutes and cost about $1. They can also spoil in hot climates.


Home Tests for HPV Could Identify Cancer Risk

HPV self-testing is as effective as tests done by doctors, according to a Lund University study. Simple HPV home tests could therefore complement existing screening programmes, and identify more women at risk for cervical cancer "We are usually able to cure cases of cancer that are identified through smear tests. For those women who have not been for smear tests, the cancer has progressed considerably further by the time it is diagnosed. It is these women who are at risk of dying from the disease", says Dr Lotten Darlin at Lund University in Sweden. The most common response when asked why they haven't attended cervical smear tests is that the tests are unpleasant, that the women felt healthy and/or that they haven't had time, according to one of Lotten Darlin's studies.


HPV a Game Changer in Head, Neck Tumors

Not that any cancer is ever “easy,” but until relatively recently, the culprit in head and neck squamous cell carcinomas was clear. The vast majority were caused by “smoking, smoking, and smoking,” says William Westra, MD, professor of pathology, oncology, and otolaryngology/ head and neck surgery, and associate director, surgical pathology, The Johns Hopkins Medical Institutions. In the last decade or so, physicians have seen a surge in the HPV-related form of head and neck cancers. The impact on patients, pathologists, and clinicians has been compelling, to say the least. And the new era is only in its genesis. As with so many other cancers—breast, lung, colon—molecular insights now mean HNSCCs no longer fall into one conveniently labeled bin. Instead, they’re distinguished by whether they’re mediated by the human papillomavirus, which, among other things, has sparked no shortage of interesting conversations among physicians. What do laboratories need to know about HPV-related head and neck squamous cell carcinomas? One of the first things to understand is that these tumors are clinically distinct from smoking-related cancers, says Dr. Westra, who is also director of The Head and Neck Pathology Consultation Service at Johns Hopkins. They’re associated with much-improved clinical outcomes, which has helped transform the pathologist’s role.


DNA Clamp to Grab Cancer Before it Develops

As part of an international research project, a team of researchers has developed a DNA clamp that can detect mutations at the DNA level with greater efficiency than methods currently in use. Their work could facilitate rapid screening of those diseases that have a genetic basis, such as cancer, and provide new tools for more advanced nanotechnology. The results of this research is published this month in the journal ACS Nano. "Beyond the obvious applications in the diagnosis of genetic diseases, I believe this work will pave the way for new applications related in the area of DNA-based nanostructures and nanomachines," notes Professor Kevin Plaxco, University of California, Santa Barbara. "Such nanomachines could ultimately have a major impact on many aspects of healthcare in the future."


Test Distinguishes Between Poppy Seeds, Heroin

Research in Wiley’s Drug Testing and Analysis explores a new test which may present a solution to this so-called “poppy seed defense.” The team sought to identify an acetylated derivative which is known to be present in street heroin, but would not be found in either poppy seeds or medicines containing opiates. The authors identified a unique glucuronide metabolite — designated ATM4G — which could be used as a marker of street heroin use.


Israeli Researchers Create Tiny, Programmable, Genetic Test Device That Can Roam the Body and Diagnose and Treat Diseases on the Spot

The genetic device holds promise for developing cancer-specific gene therapies and could create new consulting opportunities for pathologists and clinical laboratory scientists In Israel, researchers are making progress on the futuristic concept of biologic, medically-savvy computers that are so small they can fit inside human cells and roam the body detecting and treating diseases in vivo. This is another example of how new technologies can shift diagnostic testing away from clinical laboratories. This groundbreaking work is being done at the Weizmann Institute of Science in Rehovot. The research team has designed a genetic device that is inserted into bacteria cells where it operates independently. This device is programmed to identify certain disease parameters and mount an appropriate response, according to a story published by Science Daily. 


Sanford Health Invests Big in Genetic Testing

Sanford Health is making a major bet on genetic testing in primary patient care, despite uncertainties about the reliability of some tests and whether they actually help people improve their health. Through a $125 million gift from benefactor T. Denny Sanford, announced the sprawling South Dakota-based medical network will be one of the first in the nation to place genetic counselors in internal medicine clinics and to certify primary care doctors in genetic testing.


Abbott Labs Settles With U.S. Over Kickback Claims

Abbott Laboratories (ABT) has agreed to pay the United States $5.48 million to resolve allegations that it paid improper kickbacks to induce doctors to use some of its products, the U.S. Department of Justice said. The settlement resolves allegations that Abbott paid well-known doctors for teaching assignments, speaking engagements and conferences, expecting that they would arrange for the hospitals with which they were affiliated to buy Abbott's carotid, biliary and peripheral vascular products. This activity violated the federal Anti-Kickback Act and led to the submission of false Medicare claims, the government said, in a case brought under the federal False Claims Act.


OraSure Subsidiary Receives FDA Warning Letter

Government wants additional documentation related to products made at Ottawa facility
A subsidiary of Bethlehem-based OraSure has received a warning letter from the U.S. Food and Drug Administration, OraSure officials announced. The letter primarily focuses on the response by DNA Genotek, a molecular-collection systems company, to two observations issued by the FDA after a routine inspection of DNA Genotek's Ottawa, Canada, facilities in September. In the letter, the FDA requests additional documentation related to finished product acceptance testing activities for DNA Genotek's ORAcollect OC-100 collection device. The letter also said DNA Genotek does not have in place an approved premarket approval application for its ORAcollect OC-100 device. In addition, the warning states the need for additional documentation regarding design and development activities for DNA Genotek's products and focuses in particular on the design planning and design history file for its OrageneDx collection device, a product primarily used in commercial applications.


Medicare Slashes Reimbursement for BRCA Gene Testing

The Centers for Medicare & Medicaid Services (CMS) has slashed the reimbursement rate for BRCA testing by nearly half, beginning January 1, 2014. Medicare will now pay a maximum of $1440 to test for mutations in the BRCA1 and BRCA2 genes, which is about a 49% reduction from the $2795 reimbursement rate it paid in 2013. On its Web site, CMS notes that as competitors entered the market, prices for the test now range from approximately $900 to $2900. However, it is possible that these may not be the final reimbursement rates. CMS is providing an additional opportunity to collect comments from both Medicare contractors and the public until January 27. 


Nature Selects “Single-Cell Sequencing” as the 2013 Method of the Year

Nature Publishing Group has selected single-cell sequencing as its Method of the Year for 2013 ( The publication, in explaining its choice, noted that methods to sequence the DNA and RNA of single cells are poised to transform many areas of biology and medicine. The publication continued: Single-cell genome and transcriptome sequencing methods are generating a fresh wave of biological insights into development, cancer and neuroscience.


'Sticky balls' May Stop Cancer Spreading

Cancer-killing "sticky balls" can destroy tumour cells in the blood and may prevent cancers spreading, early research suggests. The most dangerous and deadly stage of a tumour is when it spreads around the body. Scientists at Cornell University, in the US, have designed nanoparticles that stay in the bloodstream and kill migrating cancer cells on contact. They said the impact was "dramatic" but there was "a lot more work to be done". The team at Cornell devised a new way of tackling the problem. They attached a cancer-killing protein called Trail, which has already been used in cancer trials, and other sticky proteins to tiny spheres or nanoparticles. When these sticky spheres were injected into the blood, they latched on to white blood cells. Tests showed that in the rough and tumble of the bloodstream, the white blood cells would bump into any tumour cells which had broken off the main tumour and were trying to spread. The report in Proceedings of the National Academy of Sciences showed the resulting contact with the Trail protein then triggered the death of the tumour cells.


Researchers Discover 'Glycan Fingerprint' for Gastric Cancer

A serum glycan "fingerprint" may eventually serve as a screening tool to identify people with Helicobacter pylori infection at risk for stomach cancer, according to a groundbreaking study published online December 10 in Cancer Prevention Research. Led by Jay Solnick, MD, PhD, from the Center for Comparative Medicine at the University of California Davis School of Medicine, an international team of researchers found 19 statistically significant differences in serum glycan expression between people diagnosed with gastric cancer and those with asymptomatic nonatrophic gastritis. "The vast majority of people — 90% — have an asymptomatic relationship with their H pylori. Of the other 10%, 1% to 3% develop stomach cancer and the rest develop ulcers. If our statistical findings turn out to have predictive value, we can identify high-risk patients for treatment and monitoring," Dr. Solnick told Medscape Medical News in an interview.


CDC Confirms Superbug Transmission via Endoscopy

Manual cleaning and high-level disinfection in an automated endoscope reprocessor (AER) may not reliably prevent transmission of multidrug-resistant bacteria by endoscopes used in endoscopic retrograde cholangiopancreatography (ERCP), according to a field investigation report published in the January 3, 2014, issue of the Morbidity and Mortality Weekly Report.


MRSA Strain Gained Dominance With Help From Skin Bacteria

It is likely that adaptations in specific MRSA lineages drove the spread of MRSA across the United States and allowed it to replace other, less-virulent S. aureus strains," says lead author Paul Planet, PhD. "Using phylogenetic analysis, we showed that the modular segments of ACME were assembled into a single genetic locus in Staphylococcus epidermidis (a relatively harmless bacterium typically found on human skin) and then horizontally transferred to the common ancestor of USA300 strains in an extremely recent event that coincided with the emergence and spread of this strain," says Planet.


Some Bacteria 'Live for Long Periods' on Toys, Books and Cribs

Researchers from the University at Buffalo in New York say two bacteria that cause many common infections in children and the elderly, such as strep throat and ear infections, can live outside the human body for long periods of time on various objects, including books, cribs and toys. The investigators found that Streptococcus pneumoniae and Streptococcus pyogenes linger on many surfaces significantly longer than previously thought, opposing previous studies that suggest the bacteria quickly die once they have left the human body. The researchers found that this bacteria is stronger than other bacteria that do not form biofilms, leading them to believe that the bacteria may linger on surfaces. Other experiments found that the biofilms were able to survive for many hours on human hands, books, hard and soft toys and surfaces, even after cleaning.


Embryonic Stem Cell Rejection Problem Fixed, Study Says

One of the toughest problems facing embryonic stem cell therapy, immune rejection of transplanted cells, may have been solved, according to a UC San Diego-led research team. The cells can be made invisible to the immune system by genetically engineering them to make two immune-suppressing molecules, according to the study. Researchers tested the approach in mice given a human immune system. Immune functioning in the rest of the animal remained active. If the approach works in people, patients receiving transplanted tissue or organs made from embryonic stem cells wouldn’t have to take harsh immune-suppressing drugs, said study leader Yang Xu, a UC San Diego professor of biology.


A Surprising Genetic Risk Factor for Type 2 Diabetes is Discovered

All environmental factors being equal, Mexican Americans and other Latinos are at nearly twice the risk of developing Type 2 diabetes than any other ethnic group. Now, an international research group known as the SIGMA (Slim Initiative in Genomic Medicine for the Americas) Type 2 Diabetes Consortium, may be a step closer to understanding why.  In the largest ever genetic study of its kind, researchers publishing in the journal Nature conducted a DNA analysis of more than 8,000 residents of Mexico and people who lived in Latin America and discovered a gene variant that highly correlates to developing the disease. People who carry one copy of the variant of this gene, named SLC16A11, have a 25 percent greater risk of developing Type 2 diabetes, while those who inherit the gene variant from both parents -- meaning they have two copies of it -- have a correlating 50 percent risk of developing the disease. The researchers estimate that this SLC16A11 variation accounts for about 20 percent of Latinos' increased risk of Type 2 diabetes.


Unhealthy Cholesterol Levels Might Raise Alzheimer's Risk

Keeping cholesterol under control may help brain as well as heart, study suggests
Keeping "bad" cholesterol in check and increasing "good" cholesterol is not only good for your heart, but also your brain, new research suggests. A study from the University of California, Davis, found that low levels of "bad" (LDL) cholesterol and high levels of "good" (HDL) cholesterol are linked to lower levels of so-called amyloid plaque in the brain. A build-up of this plaque is an indication of Alzheimer's disease, the researchers said in a university news release. The researchers suggested that maintaining healthy cholesterol levels is just as important for brain health as controlling blood pressure. "Our study shows that both higher levels of HDL and lower levels of LDL cholesterol in the bloodstream are associated with lower levels of amyloid plaque deposits in the brain," the study's lead author, Bruce Reed, associate director of the UC Davis Alzheimer's Disease Center, said in the news release. "Unhealthy patterns of cholesterol could be directly causing the higher levels of amyloid known to contribute to Alzheimer's, in the same way that such patterns promote heart disease," Reed said.


Vitamin E may Aid Those With Mild to Moderate Alzheimer's

Vitamin E is far from an Alzheimer's cure, but a new study finds it allowed trial participants to get less help from caregivers and therefore retain more independence longer. Taking high doses of vitamin E appears to help people in all stages of Alzheimer's disease, a new study suggests. Research a decade ago showed that vitamin E was helpful in late-stage Alzheimer's disease. Now a study published by the Journal of the American Medical Association finds the benefits extend to people with mild to moderate forms of the disease. "This looks very promising," said lead researcher Mary Sano, director of the Alzheimer's Disease Research Center at the James J. Peters VA Medical Center, and the Icahn School of Medicine at Mount Sinai, both in New York City.


Study Ties Diabetic Crises to Dip in Food Budgets

Poor people with diabetes are significantly more likely to go to the hospital for dangerously low blood sugar at the end of the month when food budgets are tight than at the beginning of the month, a new study has found. Researchers found no increase in such hospitalizations among higher-income people for the condition known as hypoglycemia, suggesting that poverty and exhausted food budgets may be a reason for the increased health risk.


Racism May Speed Cellular Aging in African American Men

Researchers at the University of Maryland reported that racism appears to accelerate aging in cells. In a first-ever study of its type, researchers found that African American men who reported experiencing negative effects from racial discrimination have shorter telomeres, the DNA sequences at the ends of chromosomes that are considered biomarkers for biological aging. Telomeres (officially known as leukocyte telomeres) shorten over the course of a lifetime, and previous research has connected shorter telomeres with an increased likelihood of premature death. Shorter telomeres have also been associated with life-shortening diseases such as diabetes, stroke, heart disease and dementia.


Can Ginger Help With Asthma?

Studies Find It Can Ease Symptoms by Opening Airways
The Claim: Ginger, a root known for its strong, earthy flavor, can help ease symptoms of asthma by opening constricted airways.
The Verdict: Ginger, well known as a therapy for an upset stomach, is recently getting attention among scientists for what appears to be its capacity to open constricted airways—demonstrated in several recent studies, in animals and in human cells tested in a lab.
Human tests, however, are needed to show efficacy, says American College of Allergy, Asthma and Immunology President Michael Foggs. If ginger does prove useful, he adds, it most likely would be taken with existing medicines that control the underlying airway inflammation.


Improper Use of Biocides is Public Health Concern

Biocides used in the food industry at sublethal doses may be endangering, rather than protecting, public health by increasing antibiotic resistance in bacteria and enhancing their ability to form harmful biofilms, according to a study published ahead of print in Applied and Environmental Microbiology, published by the American Society for Microbiology. This is among the first studies to examine the latter phenomenon. The study was designed to test whether exposing Escherichia coli bacteria to sub-lethal concentrations of each of three food-grade biocides could result in greater antibiotic resistance, a greater ability to form damaging and potentially virulent biofilms and to survive normally lethal doses of biocides, says corresponding author Rosa Capita of the Univ. of Leon.


Testosterone May Undermine Flu Shot's Effectiveness for Men

High levels of the hormone cause fewer antibodies to be produced, researchers say
The flu vaccine is less effective for men than women, and researchers at Stanford University believe they've figured out why. The male hormone testosterone causes genes in the immune system to produce fewer antibodies, or defense mechanisms, in response to the vaccine, they found. "Men, typically, do worse than women in immune response to infection and vaccination," said Stanford research associate David Furman, the lead study investigator.


Seasonal Flu Widespread in the United States: CDC

Nearly half of the United States is reporting widespread influenza activity, most of it attributed to the H1N1 virus that caused a worldwide pandemic in 2009, the U.S. Centers for Disease Control and Prevention said. Thousands of people die every year from flu, which peaks in the United States between October and March. The flu is spreading quickly this season, with 25 states already reporting cases, the CDC said. The virus is all around the United States right now," said Dr. Joe Bresee, chief of Epidemiology and Prevention in the CDC's Influenza Division. In 2009-2010, the H1N1 virus, also known as swine flu, spread from Central Mexico to 74 other countries, killing an estimated 284,000 people, according to the CDC. While younger people were more susceptible to H1N1 in 2009, Bresee said it is too early to tell whether the same will be true this year. This season's virus has killed six children in the United States, according to CDC data. The agency does not track adult deaths, but dozens have been reported around the country.


Infectious Disease Dominated Health News in 2013

Doctors grappled with outbreaks of measles, meningitis and salmonella, as well as a severe flu season.   The USA began 2013 in the midst of a severe flu season. Then came renewed concern over improving mental health care in response to a mass shooting. And communities across the USA this year saw outbreaks of measles in areas with low vaccination rates.


Hospitals Launch Major Infection Control Efforts

Harrington Hospital's newest weapon in the fight against dangerous bacteria is a light-flashing robot. The machine bathes patient rooms in ultraviolet light, the beams penetrating the DNA of bacteria cells and rendering them inactive. It promises to kill germs that disinfectants like bleach leave behind. And when bacteria are left behind, they can grow and enter the bodies of sick patients lying in hospital beds.


Proposed Rule Would Ease HIPAA to Strengthen Gun Background Checks

The U.S. Department of Health & Human Services' Office for Civil Rights (OCR) has issued aproposed rule Adobe PDF fileExternal Web Site Icon to ease HIPAA regulations preventing states from reporting to a database of people prohibited from owning guns for mental health reasons. The Department of Justice (DOJ) has also released a proposal Adobe PDF fileExternal Web Site Icon to clarify the definitions used.
The new HHS rule would amend HIPAA "to expressly permit certain HIPAA-covered entities to disclose to the National Instant Criminal Background System the identities of individuals who are subject to a federal 'mental health prohibitor' that disqualifies them from shipping, transporting, possessing or receiving a firearm."


Report Quantifies Difficulty of Finding Physician in U.S.

In the 12 preceding months, 2.4% of people in the U.S. reported having problems finding a general physician, according to a report. In addition, 2.1% of those interviewed had been told that a physician would not accept them as new patients, and 2.9% were told a physician did not accept their healthcare coverage. The findings appear in the December data brief of the CDC’s National Center for Health Statistics. Data came from the National Health Interview Survey, which included responses from 34,525 adults.


Growth in U.S. Health Spending Continues at Historically Slow Rate, Despite Improved Economy

New federal estimates show that U.S. health spending growth continued to grow at a historically low rate in 2012 even as the economy rebounded. The overall economy grew significantly faster than healthcare spending, which declined as a share of the nation's gross domestic product to 17.2% from 17.3% the prior year. In the fourth straight year of slow growth, national health spending in 2012 increased 3.7%, while the overall economy, continuing its rebound from the Great Recession, grew 4.6%, according to newly released estimates by economists and statisticians at the CMS.


Lab, Pathology Groups Applaud EHR Donation Exclusion

Laboratory and pathology groups received a New Year's gift from the Centers for Medicare and Medicaid Services (CMS) Adobe PDF fileExternal Web Site Icon and the Health and Human Services Office of Inspector General (OIG) Adobe PDF fileExternal Web Site Icon in late December with the announcement that labs will be excluded from the anti-kickback safe harbor and Stark exception governing donations of electronic health record (EHR) software and services to physician groups. The rule[s] [were] announced Dec. 23 and published in the Dec. 27 Federal Register. [They] became effective Jan. 1.


Health IT Growing Rapidly Through 2017

Meaningful Use regulations among the factors that will drive 7.4% annual growth rate in North America, says new research report. The North American health IT market will grow at a compound annual growth rate of 7.4% to reach a total value of $31.3 billion in 2017, compared to $21.9 billion in 2012, the research firm Markets and Markets predicted in a new report. The value of the US market, which accounts for nearly three quarters of North American HIT revenue, will rise to $22.6 billion in 2017 from $15.9 billion in 2012, according to the report.


Electronic Records System Helps Hospital cut Sepsis Mortality Rate

This sepsis reduction program uses a clinician decision support model that involves data-driven, multidisciplinary protocols to quickly identify and treat cases of sepsis. As part of the program, nurses received additional EPIC and clinical training to recognize warning signs and to call the Stop Sepsis Team (a group of specially trained nurse practitioners) if they feel a patient is at risk. A team member promptly responds to evaluate the patient, order tests, such as blood cultures and additional blood work, and initiate the indicated treatment.


New Tool Effective in Evaluating Quality of Clinical Notes

A tool called QNOTE was found effective in evaluating the quality of clinical notes, according to a study from the Maryland-based Uniformed Services University of the Health Sciences. Quality clinical notes are key to improving patient care, the authors write in an article at the Journal of the American Medical Informatics Association. The point to three key functions the notes serve:
  1. They document the clinician's information collection, problem assessment and plan for the patient;
  2. They create a complete and accurate record that can be used by other clinicians to care for the patient;
  3. They provide substantiation for what was done for legal reasons and reimbursement.


Montana Hospital Sues Developer Over Electronic Health-Record Certification

A small Montana hospital may be among the first of many providers to go to court to resolve their frustrations with electronic health record systems developers that are either lagging or failing to update their software to the new, more stringent testing and certification requirements of the federal EHR incentive payment program. “That's the most important thing in this whole deal, to be federally certified,” said Aaron Rogers, CEO of the 25-bed Mountainview. “This is a huge, huge deal for every hospital, and we're certainly in that group. Ultimately, the reason there is a lawsuit is because certification was not attained, plain and simple. It didn't meet the criteria that we have to have federally.”


First 'NanoKnife' Surgery for Hong Kong Cancer Patient at CUHK

Chinese University doctors have carried out one of the first cancer treatments in Asia to use a cutting-edge technology that employs electricity to kill cancerous cells. The percutaneous NanoKnife technology was used for the first time in Hong Kong last month on a 67-year-old with liver cancer. Three electrode needles, each 1mm in diameter, were inserted into the man’s tumour, which was then zapped with 3,000-volt electric pulses for between 20 and 100 microseconds. The treatment works for solid tumours smaller than 5cm, and the needles are guided by ultrasound and X-ray imaging so that no operation is needed. Scans showed no lesions after the treatment.


Lab to Test Cancer Carrying Gene to Open in UAE Soon

The U.A.E.'s first genome testing laboratory to test for BRCA gene mutations carrying the risk of cancer will be set up in Abu Dhabi soon, making it possible to do such tests locally. A Memorandum of Understanding to this effect has been signed by BGI Health and Star Metropolis Clinical Laboratories, a part of the Arabian Healthcare Group. 


Quest Beefs up its Indian Presence as Stateside Sales sag

Quest Diagnostics ($DGX) has made a great deal of headway in India over the past 6 years, as the oft-downgraded giant is looking to diversify its revenue sources in the face of reimbursement challenges at home. As India's PharmaBiz reports, since landing in the country in 2008, Quest has expanded to cover 25 of its largest cities, leading the way with cancer tests and sequencing-based diagnostics. India long lagged behind the West in access to high-tech testing services, and Quest was among the first to offer mutation-targeting assays in the country, the company said.


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