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DLPSS|HEALTHCARE NEWS|January 23, 2014 ▲ Laboratory Science, Policy and Practice Program Office


Healthcare News

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


January 23, 2014

View Previous Issues - Healthcare News Archive

CDC Wins in Budget Deal

The Centers for Disease Control and Prevention will see an 8.2 percent budget increase for fiscal 2014, thanks to a $1.1 trillion spending bill announced by Congress Jan. 13. This influx of cash will raise the CDC budget to $6.9 billion, which is $567 million more than it received in 2013. 
Of the $6.9 billion, $1.3 billion was allocated to protect the United States from foreign and domestic threats, both intentional and naturally occurring. $255 million will go to support bio-defense efforts, and $160 million will be set aside for states to address their most pressing public health needs. The CDC will get $30 million for Advanced Molecular Detection (AMD), which will help identify potential disease outbreaks earlier and more accurately.


Smoking Causes Diabetes, Colon Cancer, New Report Says

A new report from the surgeon general finds that smoking causes even more physical and financial damage than previously estimated, killing 480,000 Americans a year from diseases that include diabetes, colorectal cancer and liver cancer. The report, released, represents the first time the surgeon general has concluded that smoking is "causally linked" to these diseases. The report finds that smoking causes rheumatoid arthritis, erectile dysfunction and macular degeneration, a major cause of age-related blindness. Smoking causes inflammation, impairs immune function and increases the risk of death from tuberculosis, an infectious disease. Smoking also harms pregnant women and their fetuses by causing birth defects called cleft lips and palates and by causing ectopic pregnancy, which occurs when a fertilized egg implants in the fallopian tubes instead of the uterus. The new report — issued 50 years after the first surgeon general report on smoking — finds that exposure to secondhand smoke, previously linked to cancer and heart attacks, also causes strokes. "Amazingly, smoking is even worse than we knew," says Thomas Frieden, director of the Centers for Disease Control and Prevention. "Even after 50 years, we're still finding new ways that smoking maims and kills people."


E-cigarettes' Growing Popularity Poses Danger to Kids

In 2009, the U.S. Food and Drug Administration (FDA) issued a warning that e-cigarettes were being marketed to minors. Reports of e-cigarette poisoning among children have increased as have reports of high school students using e-cigarettes. Currently, the FDA does not ban the sale of e-cigarettes to minors. The nicotine cartridges are often flavored and in addition to more common tobacco flavors, such as menthol, e-cigarettes are also available in bubblegum and cola. "Kids will eat most anything and since children are not used to consuming nicotine, their symptoms may be more severe at lower levels," said George Rodgers, associate medical director of the Poison Control Center. 


New Pennsylvania Law May Level Competitive Playing Field

Pennsylvania has moved to prohibit the placement of laboratory employees in physician offices by any laboratory, whether in-state or out-of-state. By doing so, the state removes an incentive often too costly for small labs to easily provide and levels the playing field for laboratories operating in the state. Senate Bill 1042, which amend Pennsylvania’s Clinical Laboratory Act, not only prohibits any laboratory from placing employees in a physician office but it also prohibits leasing or renting space within a physician's office for any reason.


State Lab Director: 'It's All About the Babies'

In a special report titled "Deadly Delays," the Milwaukee Journal Sentinel newspaper showed this past fall that Iowa and Delaware are the only two states in the U.S. that get blood samples from babies and quickly transport them to a lab for analysis as required by federal law. While all states may take the samples, the report found that how and when they are transported to a lab varies widely across the nation. The Iowa State Hygienic lab is centrally located in Ankeny for what is called the Newborn Screening Program. The lab operates in partnership with the Iowa Department of Public Health in Des Moines and the University of Iowa Children's Hospital in Iowa City.


Microbiology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement: March 12, 2014

On March 12, 2014, the committee will discuss, make recommendations, and vote on a premarket approval application for a new indication for the cobas Human Papillomavirus (HPV) Test, sponsored by Roche Molecular Systems, Inc.  The cobas HPV Test is a qualitative in vitro test for the detection of HPV that is currently approved for use in conjunction with cervical cytology. Roche is seeking a claim whereby the cobas HPV Test can be used as a first-line primary cervical screening test.  The test utilizes amplification of target DNA by the polymerase chain reaction and nucleic acid hybridization for the detection of 14 high risk (HR) HPV types in a single analysis. The test specifically identifies types HPV 16 and HPV 18 while concurrently detecting the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68).  Per the proposed indication, women who test negative for high risk HPV types by the cobas HPV Test would be followed up in accordance with the physician’s assessment of screening and medical history, other risk factors, and professional guidelines. Women who test positive for HPV genotypes 16 and/or 18 by the cobas HPV Test would be referred to colposcopy.  Women who test high risk HPV positive and 16/18 negative by the cobas HPV Test (12 other HR HPV positive) would be evaluated by cervical cytology to determine the need for referral to colposcopy.


Testing Decisions

A handful of universities have already launched programs that enable students to learn about their genomes, including the University of California, Berkeley, Stanford University, which caused consternation when they asked students to take DNA tests as part of a course, New Scientist notes. The Icahn School of Medicine at Mount Sinai University has taken a different tack, launching a study into how 19 students decided whether or not to have their genomes sequenced as part of their genetics course. The study, by health psychologist Saskia Sanderson, found that a brief course that discusses the sequencing technique and issues involved with it was useful. 


Pay-for-Value Genetic Tests

While the Coverage with Evidence Determination (CED) provides an effective coverage determination process for many new devices and treatments, it fails to capitalize on the opportunities in the molecular diagnostics (MDx) market, and does not adequately account for the unique challenges of precision medicine.  Although MDx tests offer significant opportunity to reign in healthcare costs and influence health outcomes, the possibility of coverage-related delays in the development and clinical use of laboratory tests needed to drive new patient therapies is all too real. To overcome coverage determination challenges for new genetic tests and realize their full benefit, a technology-enabled, risk-sharing, data-driven process is needed to provide the speed and agility demanded by patients and physicians, the real-world utilization data required by laboratories, and demonstrated value demanded by payors.  


Blood Test to Locate Gene Defects Associated With Cancer May Not Be Far Off

Some surprising research findings from scientists at The University of Texas MD Anderson Cancer Center suggest it's possible a simple blood test could be developed to determine whether gene mutations associated with pancreatic cancer exist without the need of locating and testing tumor tissue. This appears possible following the discovery that tiny particles the size of viruses called 'exosomes,' which are shed by cancer cells into the blood, contain the entire genetic blueprint of cancer cells. By decoding this genomic data and looking for deletions and mutations associated with cancer, the research team believes this discovery could be translated into a test that helps physicians detect cancer and treat patients.


New Biopsy Test Could Pick Out Aggressive Form of Skin Cancer

Testing the genetic profile of immune cells next to a melanoma could lead to more accurate diagnosis to spot whether a skin cancer is aggressive enough to spread, researchers from Italy have found. Development of the research finding could enable doctors to focus cancer treatment on skin cancer patients who need it - while sparing the harm of intervening when patients do not need it. Monica Rodolfo, PhD - an immunotherapy scientist at Italy's National Cancer Institute in Milan - led the study, which has been published in Cancer Research, a journal of the American Association for Cancer Research.  "Using the study of genetic profiles, we found that the sentinel node contains information useful to foresee whether or not a patient with melanoma will have an aggressive cancer," Rodolfo says, adding: "Although this study has a relatively small number of patients, it provides proof-of-principle that the immune system is crucially involved in controlling tumor growth, and that sentinel nodes are endowed with precise information on cancer behavior."


New Test for Pancreatic Cancer Based on MicroRNAs in Blood

A new test for pancreatic cancer based on detecting microRNAs in whole blood is described by researchers from Denmark in the January 22/29 issue of JAMA. The team, led by Nicolai Schultz, MD, PhD, from Herlev Hospital, Copenhagen University Hospital, developed 2 novel panels of microRNAs, which are small noncoding single-stranded RNAs (about 18 to 24 nucleotides) that act on target genes at the messenger RNA level to promote oncogenesis.
They suggest that using their microRNA tests in combination with serum CA19-9 for screening patients with symptoms could identify the disease at an earlier stage, and "thus could have potential to increase the number of patients that can be operated on and possibly cured of pancreatic cancer."
However, the researchers caution that their findings are preliminary.


Detecting Cervical Cancer Using Simple Test

To generate a plasma thermogram, a blood plasma sample is "melted" producing a unique signature indicating a person's health status. This signature represents the major proteins in blood plasma, measured by Differential Scanning Calorimetry (DSC). The University of Louisville researchers see great promise for their technique being able to detect and monitor in a range of other cancers and diseases. The test is non-invasive and requires only a simple blood draw. The plasma thermogram test has already been applied to identify multiple cancers, including melanoma, lung, cervical, ovarian, endometrial and uterine cancers and other diseases, including lupus, rheumatoid arthritis, Amyotrophic lateral sclerosis (Lou Gehrig's Disease) and Lyme disease. The test has shown great promise as a prognostic indicator of disease, allowing physicians to monitor cancer patients more closely for remission, response-to-therapy and recurrence.


Gold Core Nanoparticles Allow for Precise Tracking of Enteroviruses

Enteroviruses are a cause of a bunch of infamous and pernicious diseases, from polio to hand, foot and mouth disease, but because of their size and variability studying them has proven to be a significant challenge. Being able to attach tracking particles that are discreet enough not to affect the behavior of the virus may revolutionize our ability to study these pathogens, perhaps as significantly as green fluorescent protein (GFP) has done for cellular science. The study also showed that the infectivity of the viruses is not compromised by the attached gold particles, which indicates that the labelling method does not interfere with the normal biological functions of viruses inside cells. 


Test at Home Could Detect Early Alzheimer's

It’s best to detect and treat Alzheimer’s as early as possible. According to a study published in The Journal of Neuropsychiatry and Clinical Neurosciences, a new test may be able to help. The Self-Administered Gerocognitive Examination (SAGE) is a 15-minute written test that assesses different cognitive capabilities—such as orientation, language, reasoning, visuospatial, problem-solving and memory—to determine any potential impairment. The highest score possible is 22 points. Losing six or more points may indicate that it may be time for a person to see a doctor. Researchers at Ohio State University put SAGE to the test. They asked 1,047 individuals age 50 and older to take the exam at 45 different community events. The results showed 28 percent of the test takers had some cognitive troubles. Afterward, all participants received their scores, along with additional written materials, and were encouraged to discuss the results with their doctors.


'Suicide Test' May Aid Antidepressant Decision Making

A genetic test in development promises to help doctors identify patients at increased risk for suicide after starting antidepressant therapy. The test for treatment-emergent suicidal ideation is based on research carried out at the Max Planck Institute of Psychiatry in Munich, Germany, and published in 2011 in the journal Neuropsychopharmacology. The researchers identified 79 single nucleotide polymorphisms associated with suicidality in new users of antidepressant medication.


Saliva Reveals Asthmatic Kids' Smoke Exposure

Asthmatic children who are exposed to cigarette smoke are more likely to make repeat trips to the hospital for breathing problems. But researchers say asking parents about kids' smoke exposure may not yield the most reliable information. In a recent study, saliva revealed exposure to tobacco smoke in roughly 80 percent of children brought to the hospital for asthma or breathing problems. But only about a third of parents said their children came in contact with smoke. What's more, finding evidence of nicotine, a chemical in tobacco, in children's saliva was a better predictor of whether they would need to come back to the hospital, compared to the information parents gave to doctors. "We think saliva is a good and potentially useful test for assessing an important trigger for asthma," Dr. Robert Kahn, the study's senior author, told Reuters Health.


'Smart Contact Lens' Could Help Millions With Diabetes

Google has announced it's testing a smart contact lens that can help measure glucose levels in tears. The contacts contain a tiny wireless chip and a sensor. The company is hoping the technology could lead to a new way of helping people with diabetes manage their disease. David Grossman reports from Google headquarters in California.


A New Blood Test Could Help Doctors Pinpoint the Cause of a Stroke

Clinical trials are underway for what could be a first-of-its-kind blood test that would help doctors determine what caused a patient to have a stroke. Developed by Cincinnati-based Ischemia Care, the test isolates RNA from whole blood and examines immune responses, with the goal of differentiating where an ischemic stroke originated in a patient’s body. Being able to determine whether the stroke originated in the heart or in the blood vessels could have a huge impact on how patients are treated and on preventing recurrent strokes, said CEO Jeff June. While there are other blood tests that physicians use to determine whether a patient has had a stroke, June said this is the first technology he’s aware of that looks for immune markers 


Baby DNA Analysis Ushers in Brave New World of Treatment

Hundreds of babies across the U.S. are having massive portions of their DNA deciphered as part of a five-year, U.S. - funded project to understand and navigate the brave new world of infant genetic testing. Kingsmore and a handful of other scientists are taking gene sequencing to the next level, using the technology to design treatment for infants with rare and unusual illnesses, and in some cases, finding therapies for genetic abnormalities never seen before. “The big picture is that medicine will be transformed when the genome is part of our medical record,” he said in an interview in his laboratory. “The art of medicine will move closer to becoming a science.”


DNA 'Barcoding' Enables Simultaneous Analysis of Cancer-related Proteins

New DNA "barcoding" technology developed by researchers at Massachusetts General Hospital allows for simultaneous analysis of hundreds of cancer-related protein markers from patient samples, garnered through minimally invasive methods. The technology uses antibodies linked to DNA "barcodes" to detect proteins, according to an announcement from MGH. This will allow clinicians to gain more insight into how cancer progresses, and also enable them to show why cancer therapies stop working or are ineffective.


FDA Allows Marketing for First-of-its-kind Post-natal Test to Help Diagnose Developmental Delays and Intellectual Disabilities in Children

U.S. Food and Drug Administration authorized for marketing the Affymetrix CytoScan Dx Assay, which can detect chromosomal variations that may be responsible for a child’s developmental delay or intellectual disability. Based on a blood sample, the test can analyze the entire genome at one time and detect large and small chromosomal changes. According to the National Institutes of Health and the American Academy of Pediatrics, two to three percent of children in the United States have some form of intellectual disability. Many intellectual and developmental disabilities, such as Down syndrome and DiGeorge syndrome, are associated with chromosomal variations. “This new tool may help in the identification of possible causes of a child’s developmental delay or intellectual disability, allowing health care providers and parents to intervene with appropriate care and support for the child,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “The FDA’s review of the test provides clinical laboratories with information about the expected performance of the device and the quality of the results.”


VascuLogic Develops Automated Venipuncture Medical Device

It is expected to improve paediatric experience
A team of researchers from VascuLogic, LLC, have developed an automated venipuncture medical device that automates the phlebotomy procedure, either for blood draws or the placement of IV lines. In both in vitro and in vivo validation studies, including validation on human subjects, reportedly the device demonstrated greater than 95 per cent first stick accuracy, and additionally outperformed human phlebotomist controls. 56 per cent of the adult population and 82 per cent of paediatric population suffer from trypanophobia, the fear of needles. Tryphanophobia is just one of the issues faced by clinicians when needing to draw blood.


Hemanext Banks on Removing Oxygen to Extend the Shelf Life of Donated Blood

Technology developed nearly two decades ago with the goal of allowing U.S. Navy submarines to remain submerged for longer periods of time might be making some waves here on land within the next few years. New Health Sciences has been quietly developing a system based on work done at Los Alamos National Laboratory to improve the quality of transfused blood and potentially extend its shelf life by storing it anaerobically after donation.


Corning Unveils World's First Antimicrobial Cover Glass

Corning Incorporated unveils Antimicrobial Corning® Gorilla® Glass at the International Consumer Electronics Show (CES). It is the first EPA-registered antimicrobial cover glass. The glass is formulated with an antibacterial agent, ionic silver, which is incorporated into the glass surface for sustained activity. "Corning's Antimicrobial Gorilla Glass inhibits the growth of algae, mold, mildew, fungi, and bacteria because of its built-in antimicrobial property, which is intrinsic to the glass and effective for the lifetime of a device," said James R. Steiner, senior vice president and general manager, Corning Specialty Materials.


J&J Said to Agree to Sell Ortho Unit to Carlyle for $4 Billion

Johnson & Johnson (JNJ) agreed to sell its Ortho Clinical Diagnostics unit to Carlyle (CG) Group LP for about $4 billion and may make an announcement soon, people with knowledge of the matter said. Carlyle, based in Washington, plans to operate the business as a stand-alone entity after the acquisition, said one of the people, who asked not to be named because the negotiations are private. Carlyle has asked banks to line up about $3.3 billion in debt for the acquisition, with the rest funded by cash, the person said.


Feds Rescind Sanctions Against CHC [Saipan, Mariana Islands]

THE Centers for Medicare & Medicaid Services has rescinded its sanctions against the Commonwealth Healthcare Corp. In a letter, Karen Fuller, state oversight and clinical laboratory improvement amendments, or CLIA, branch manager of CMS-Division of Survey and Certification, informed CHC Chief Executive Officer Esther L. Muña of the federal agency’s decision to rescind the sanctions imposed on the corporation on Dec. 17, 2012. The sanctions rescinded were the revocation of the CLIA certificate of compliance, the cancelation of the laboratory’s approval to receive Medicare payments and the directed portion of a plan of correction. CMS conducted a follow-up on-site survey from Dec. 16 to 20, exactly one year after the imposition of sanctions. 


23andMe and Udacity Launch ‘Massive Online Open Course’ in Human Genetics

Innovative web-based educational formats might add value to training initiatives for pathology residents and fellows and medical laboratory workers. In the final months of 2013, the regulatory fight between gene testing company and the Food and Drug Administration (FDA) generated national headlines. In that encounter, blinked and ceased offering health-related genetic tests to consumers. However, the company continues to work to position itself as a major player in genetic testing and genetic medicine. In the second half of 2013, for example, initiated a business campaign to position itself as a source of on-line information about genetics for educational purposes. Its partner in this effort is Udacity, another Silicon Valley company. It was last September with the two companies announced that they would collaborate in the fast-growing trend of “massive open online courses” (MOOCS).


FDA Limit on 23andMe Genetic Tests Called Unwarranted

The Food and Drug Administration's recent action to stop the sale of genetic tests by the company 23andMe is unwarranted, according to scholars who argue that recent research shows such tests do not cause people distress, or encourage risky behavior. But today, some legal and genetic experts are calling the FDA's approach overcautious. The FDA is basing its concern on speculation, rather than proven harms, said Nita Farahany, a professor of genome sciences and policy at Duke University.


Mathematical Modeling of Systems Pharmacogenetics by Researchers at Penn State May Create New Opportunities for Clinical Pathology Laboratories

In one study, researchers combined pharmacogenomics and newly developed differential equations to determine differences in patients’ reactions to drugs based on their genetic makeup, according to a story published at This research could allow clinicians to predict a specific patient’s response to a specific drug. Additionally, the innovation could help deliver treatments to specific disease targets. This study was sponsored by the National Institutes of Health, Penn State University and Beijing Forestry University. “Traditional medicine doesn’t consider mechanistic drug response,” stated lead author Rongling Wu, Ph.D., Director of the Center for Statistical Genetics and Professor of Public Health Sciences at the Penn State College of Medicine. Instead, drugs were traditionally prescribed according to a ‘one size fits all’ model,” suggested Munir Pirmohamed, Ph.D. He is Professor, Department of Pharmacology and Therapeutics, University of Liverpool and was quoted in a paper published in The British Journal of Clinical Pharmacology.


New Therapy Tries to Repair Damage in Heart Attacks

In a heart attack, the initial harm is often compounded by a person's immune system, which rushes "soldiers" to the heart to fight what it thinks are invaders. An immune system overreaction also causes much of the trouble in irritable bowel syndrome, multiple sclerosis and West Nile Virus. "The immune system does a significant amount of damage while it's trying to protect us," said immunologist Daniel Getts, a visiting researcher at Northwestern University Feinberg School of Medicine in Chicago. Now, Getts and several colleagues have figured out a way to trick the immune system into attacking tiny synthetic particles, instead of the body. Their research, published in Science Translational Medicine, is still in its early days and the technique has been tested only in mice. But if it is shown to work in people, it could transform treatment for a wide variety of ailments.


Gene Therapy 'Could Be Used to Treat Blindness'

Surgeons in Oxford have used a gene therapy technique to improve the vision of six patients who would otherwise have gone blind. The operation involved inserting a gene into the eye, a treatment that revived light-detecting cells. The doctors involved believe that the treatment could in time be used to treat common forms of blindness. Prof Robert MacLaren, the surgeon who led the research, said he was "absolutely delighted" at the outcome. "We really couldn't have asked for a better result," he said.


Gene Mutation of "Maturity-onset Diabetes of youth" (MODY) May Provide Insights Into Diabetes

Patients with a genetic mutation that causes stable, mildly elevated blood glucose levels rarely develop typical diabetes-related complications, a new study finds. The results, which may provide insight into the isolated role of glucose in the development of complications among patients with other types of diabetes, were published in the January 14 issue of the Journal of the American Medical Association by Anna M. Steele, PhD, of the National Institute for Health Research, Exeter Medical School, United Kingdom, and colleagues. Mutation in the GCK gene causes abnormalities in the action of glucokinase, which regulates the secretion of insulin from the pancreatic beta cells in response to blood glucose levels. As a result, higher glucose concentrations are required to trigger insulin release. Patients with this mutation, one of several associated with "maturity-onset diabetes of youth" (MODY), typically don't require glucose-lowering treatment outside of pregnancy, and their blood pressure and lipid levels are similar to those of the general population. Previous studies have suggested that, despite having mild hyperglycemia from birth, these patients rarely experience diabetes-related eye, kidney, nerve, and cardiovascular complications. But no trial has systematically assessed this, Dr. Steele and colleagues say.


Low Melatonin May Up Risk of Prostate Cancer

Higher urinary melatonin levels had a significant inverse association with risk of aggressive prostate cancer, data from a cohort study showed. Men with the higher levels of 6-sulfatoxymelatonin had a 75% lower risk of aggressive prostate cancer than men who had levels below the median. Urinary melatonin had a near-significant association with overall prostate cancer risk, Sarah Markt, MPH, of the Harvard School of Public Health, reported at the Conference on Advances in Prostate Cancer Research in San Diego, which was co-sponsored by the American Association for Cancer Research and the Prostate Cancer Foundation.


Scientists Explore Effect of Exercise on Prostate Cancer Patients

A new study offers a possible explanation of how exercise may improve outcomes for prostate cancer patients. It's known that prostate cancer patients who are more active have a lower risk of cancer recurrence and cancer death than those who get little or no physical activity, but the reasons for this are unclear. In this study, researchers looked at 572 prostate cancer patients and found that those who walked at a faster pace before their diagnosis had more regularly shaped blood vessels in their prostate tumors than those who walked slowly. Specifically, men with the fastest walking pace (3.3 miles to 4.5 miles per hour) before diagnosis had 8 percent more regularly shaped blood vessels than those with the slowest walking pace (1.5 miles to 2.5 miles per hour), according to the study.


Protein Breakthrough Brings HIV Vaccine Closer to Reality

A team of researchers has determined the structure of a key part of the HIV envelope protein, the gp41 membrane proximal external region (MPER), which previously eluded detailed structural description. The research by scientists at Duke University will help focus HIV vaccine development efforts, which have tried for decades to slow the spread of the virus. "One reason vaccine development is such a difficult problem is that HIV is exceptionally good at evading the immune system. The virus has all these devious strategies to hide from the immune system," author Bruce Donald said.


H.I.V.-Positive Person, Told Otherwise, Is Being Sought

For the last six weeks, Walter Reed National Military Medical Center has been engaged in a highly unusual effort to identify an individual who is H.I.V. positive but was wrongly informed that he or she was H.I.V. negative after a mix-up of blood samples taken at the hospital. The mistake occurred in late October when the military’s flagship hospital, in Bethesda, Md., sent 150 blood samples to a contract laboratory for analysis. One sample tested positive for H.I.V., hospital officials said, but it was wrongly labeled with the name of a patient who subsequent tests showed was not infected. A hunt is now underway to identify the infected person, who may be in need of treatment and could be unknowingly infecting others through unprotected sex or the sharing of needles.


Night Work 'Throws Body Into Chaos'

Doing the night shift throws the body "into chaos" and could cause long-term damage, warn researchers. Shift work has been linked to higher rates of type 2 diabetes, heart attacks and cancer. Now scientists at the Sleep Research Centre in Surrey have uncovered the disruption shift work causes at the deepest molecular level. Experts said the scale, speed and severity of damage caused by being awake at night was a surprise.


Improved Regulations to Protect Human Research Subjects Would Reduce Burden on IRBs While Better Protecting Study Participants 

Proposed updates to federal regulations that protect human research subjects need additional clarification when applied to the social and behavioral sciences, says a new report from the National Research Council. The report reviews an Advance Notice of Proposed Rulemaking (ANPRM) from the U.S. Department of Health and Human Services (HHS), issued in July 2011 to strengthen protection for human subjects, and recommends how best to ensure those protections while promoting effective social and behavioral science research and also respecting the different contexts and processes of biomedical research.


ONC Suite of Guides Aims to Boost EHR Safety

The Office of the National Coordinator for Health IT announced that it has issued nine guides to help healthcare organizations assess the safety of electronic health records and to use them effectively. Known as the Safety Assurance Factors for EHR Resilience (SAFER) Guides, they offer a suite of tools that include checklists and recommended practices to boost EHR safety.
The nine guides are:
  • High Priority Practices
  • Organizational Responsibilities
  • Patient Identification
  • CPOE with Decision Support
  • Test Results Review and Follow-up
  • Clinician Communication
  • Contingency Planning
  • System Interfaces
  • System Configuration

House Clamps Down on iEHR

The House Omnibus Appropriations Act, passed Jan. 15, included project funding restrictions for the interagency electronic health record program known as iEHR. "The actions of the Departments of Defense and Veterans Affairs in developing an electronic health record continue to be of concern to the Committees," the bill read. Original estimates for the iEHR were estimated to be between $4 billion and $6 billion. However, in September 2012, the Interagency Program Office doubled its previous estimates, pegging the final price tag somewhere between $8 billion and $12 billion. However, both estimates proved to be grossly inaccurate, as costs climbed to a whopping $28 billion early last year.


Are Drug Companies Using Your Health Records to Sell You Stuff?

New regulations in the Affordable Care Act restrict access to doctors by pharmaceutical companies. As a result, drug companies are finding their way behind the medical industry's closed doors via digital record-keeping systems. The problem is that consumers don't want health information used to sell them medical services. They also don't want their doctors' medical judgment to be compromised by the financial clout of the pharmaceutical industry. When doctors at the Heart of Wellness clinic in Olympia, Washington, log on to their network to update patient data, they see advertising. Sometimes it's just house ads from Practice Fusion, the software company that operates their system, and sometimes it's full-color ads for prescription drugs such as Pristiq, a depression drug from Pfizer Inc, the kind any consumer might see on a public website.


OSHA Launches Worker-Patient Safety Resource for Hospitals

A new Occupational Safety & Health Administration (OSHA) educational resource aims to help hospitals promote worker and patient safety and assess safety needs, according to EHS Today.  In 2012, there were 250,000 work-related injuries and illnesses in U.S. hospitals, according to the article, and nearly 60,000 of them required employees to miss work. These injuries and illnesses cost hospitals $2 billion a year in workers' compensation, EHS Today reports. That's why OSHA launched the hospital-specific Internet resource, which provides hospitals with self-assessments, best practice guides and fact books. The site also includes resources on the injuries most common to hospital workers, such as slips and falls, violence, overexertion and exposure to substances, and how to reduce the risk and the cost associated with them.


Doctors' Dress Code Aims to Halt Nasty Germs

A new dress code for doctors, nurses and other health care workers calls for outfits that may be short on style, but long on what it takes to keep dangerous germs from spreading among patients. Short sleeves, bare hands and forearms and white coats that are laundered at least once a week — if not more often — are the keys to keeping nasty bugs such as Staphylococcus aureus from hitching a ride on a doctor’s wrist.


Patients Using Telehealth Services to Hit 7 Million by 2018

The number of patients worldwide using telehealth services will rise from less than 350,000 in 2013 to roughly seven million in 2018, according to a new report published by IHS Technology. Additionally, the report estimates that revenue for telehealth services will balloon tenfold, from $440.6 million in 2013 to $4.5 billion in 2018. The report's authors point to the introduction of mobile health hubs and projected growth in wearable technology as catalysts for such growth.


Support for Nation's Emergency Medical Care Gets D-plus

Sorry, America: Support for emergency care patients barely receives a passing grade and needs extra help, according to a new report. The American College of Emergency Physicians, a national medical specialty society, issued a "report card" assessing the country's emergency medical services. As a whole, the United States got a measly D-plus. "This report card is saying: The nation's policies are failing to support emergency patients," Alexander Rosenau, president of the American College of Emergency Physicians, said.


Patients’ Costs Skyrocket; Specialists’ Incomes Soar

Doctors’ charges — and the incentives they reflect — are a major factor in the nation’s $2.7 trillion medical bill. Payments to doctors in the United States, who make far more than their counterparts in other developed countries, account for 20 percent of American health care expenses, second only to hospital costs. Specialists earn an average of two and often four times as much as primary care physicians in the United States, a differential that far surpasses that in all other developed countries, according to Miriam Laugesen, a professor at Columbia University’s Mailman School of Public Health. That earnings gap has deleterious effects: Only an estimated 25 percent of new physicians end up in primary care, at the very time that health policy experts say front-line doctors are badly needed, according to Dr. Christine Sinsky, an Iowa internist who studies physician satisfaction. In fact, many pediatricians and general doctors in private practice say they are struggling to survive. Studies show that more specialists mean more tests and more expensive care. “It may be better to wait and see, but waiting doesn’t make you money,” said Jean Mitchell, a professor of health economics at Georgetown University. “It’s ‘Let me do a little snip of tissue’ and then they get professional, lab and facility fees. Each patient is like an ATM machine.”
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