A Weekly Compilation of Clinical Laboratory and Related Information
from The Division of Laboratory Science and Standards
April 4, 2013
- Obama Proposes Brain Mapping Project
- Braintree Teen’s Tick Study Makes CDC Take Notice
- Not Every Woman Should get the BRCA Gene Test, U.S. Task Force Says
- Friedewald-derived LDL Misclassifies Patients at low end of LDL Spectrum
- Newly Identified Genetic Variations May Help Screen for Cancers
- New Cancer Diagnostic Technique Debuts
- Scientists Leaving Labs and Heading for Cubicles
- The Healthcare System's Perfect Storm
- Studies: Residents Make More Errors on Shorter Shifts
View Previous Issues - Healthcare News Archive
Obama Proposes Brain Mapping Project
US President Barack Obama has unveiled a new initiative to map the brain.
Speaking at the White House, he announced an initial $100m investment to shed light on how the brain works and provide insight into diseases such as Alzheimer's and epilepsy. President Obama said initiatives like the Human Genome Project had transformed genetics; now he wants to do the same with the brain. The project will be carried out by both public and private-sector scientists. The project is called Brain Research Through Advancing Innovative Neurotechnologies - or BRAIN. Mr. Obama said: There is this enormous mystery waiting to be unlocked, and the BRAIN initiative will change that by giving scientists the tools they need to get a dynamic picture of the brain in action and better understand how we think and learn and remember. And that knowledge will be transformative."
The project will begin in 2014, and will involve the National Institutes of Health (NIH), the Defense Advanced Research Projects Agency (Darpa), and the National Science Foundation (NSF).
Confirmation Hearing Set for Tavenner at CMS
Senate Finance Committee Chairman Max Baucus (D-Mont.) has scheduled a confirmation hearing next week to consider President Barack Obama's nomination of Marilyn Tavenner to be CMS administrator. Tavenner, who currently serves as the CMS' acting administrator, is a nurse who spent 25 years of her career working for HCA.
FDA Issues New Guidance on Medical Device User Fee Refunds and Exceptions
The federal watchdog agency described user fee protocols for both 510k and premarket approval applications, laying out the general guidelines the FDA will follow in determining whether the applicant may be able to request a user fee refund. The new guidance fits with the FDA's new Medical Device User Fee & Modernization Act, which Congress authorized in June 2012 to bump up the user fees that medical device makers pay for agency review. The agency has since issued new guidances on 510(k) time-frames, PMA approval time lines, 510(k) pre-review sessions and more in efforts to streamline and clarify the medical device review pathway.
More Diagnoses of Hyperactivity in New C.D.C. Data
Nearly one in five high school age boys in the United States and 11 percent of school-age children over all have received a medical diagnosis of attention deficit hyperactivity disorder, according to new data from the federal Centers for Disease Control and Prevention. These rates reflect a marked rise over the last decade and could fuel growing concern among many doctors that the A.D.H.D. diagnosis and its medication are overused in American children.
The figures showed that an estimated 6.4 million children ages 4 through 17 had received an A.D.H.D. diagnosis at some point in their lives, a 16 percent increase since 2007 and a 53 percent rise in the past decade. About two-thirds of those with a current diagnosis receive prescriptions for stimulants like Ritalin or Adderall, which can drastically improve the lives of those with A.D.H.D. but can also lead to addiction, anxiety and occasionally psychosis.
Braintree Teen’s Tick Study Makes CDC Take Notice
Jacqueline Flynn knew she was on to something, when, one by one, the ticks began to die. The science sleuth had been holed up in front of clothes dryer for hours, watching and waiting as small mesh bags full of blacklegged deer ticks whirled.
How long can ticks resist heat before perishing? She wondered. Not long, it seems.
That discovery by the 16-year-old Braintree High School student has won top local science prizes and has caught the attention of scientists at the Centers for Disease Control and Prevention, the nation’s massive health watchdog. As part of its tick prevention recommendations, CDC literature urges tumbling tick-infected clothing in a dryer on high heat for at least an hour as one way to eliminate the bloodsucking arachnids. But the agency had not studied the method further.
Flynn’s work concluded that it should take only five minutes at low heat.
Instituting a geographically based value index in Medicare that would change payment rates for physicians and other health professionals based on how much program spending is incurred by different regions could lead to serious adverse effects on the system, according to preliminary research by the Institute of Medicine.
In 2009, Congress requested that the IOM investigate evidence of wide disparities in Medicare spending among different regions of the U.S. that appear to have little correlation to patients’ health outcomes — evidence that many experts say indicates wasteful program spending in some parts of the country. Lawmakers asked the IOM specifically to consider whether adopting a regional value index, which would alter pay rates based on a given region’s composite cost and quality measures, could help encourage higher-value care.
In an interim report released by an IOM committee on March 25, the research organization said making such regional pay adjustments would not give individual physicians and other health professionals the correct incentives to boost the quality of their care and provide services more efficiently. Because decisions about patient treatments are made at the level of patient care, not at a regional level, setting geographic payments in such a way would create an inequitable situation for doctors and others, the committee stated.
Oversight Committee Passes IT Reform Act, Giving CIOs Budget Authority
The Federal Information Technology Acquisition Reform Act would make agency chief information officers presidential appointees. It would also grant them authority to shift funding between technology projects, a power now only granted to the Veterans Affairs Department CIO.
The legislation was jointly sponsored by Oversight Chairman Rep. Darrell Issa, R-Calif., and by Rep. Gerry Connolly, D-Va. It’s now on its way to the full House for consideration. Complementary legislation has not yet been introduced in the Senate.
Lawmaker Urges Extension of Safe Harbor for EHRs
Normally, it would be illegal for a hospital to donate electronic medical-record software to an independent doctor who refers patients for treatment at the hospital. But federal officials created special rules to allow such transfers as a way to encourage healthcare providers to adopt the costly systems. Those exceptions to the Stark law and the anti-kickback statute are due to expire at the end of the year, and observers say they would like to see quick action to renew them.
Mo. Senate Passes Required Telemedicine Coverage
The Missouri Senate has approved legislation requiring insurance companies to cover medical services provided electronically if they cover for the same service delivered in person. Under the legislation, people receiving medical treatment through "telemedicine" would not face higher co-pays or deductibles than they would for a face-to-face doctor visit. Senators voted 34-0 to send the measure to the House.
HIV Case Headed to Minnesota Supreme Court Draws National Interest
Medical experts and civil liberties advocates nationwide are weighing in on the Minnesota Supreme Court case of an HIV-positive Twin Cities man convicted and later cleared of a felony for having unprotected sex, arguing that the 17-year-old state law under which he was convicted should be rewritten in the interest of science and justice.
At issue is Daniel Rick’s felony attempted assault conviction in Hennepin County, even though a jury found he informed his partner he was HIV positive. His attorneys argued that the law he was convicted of applied to medical procedures, not sexual intercourse. Opponents of the law argue that it has a chilling effect on the rights of those who are HIV positive to engage in consensual sex when they’ve informed their partner
A bacterial disease spread by tick bites is getting attention in the Statehouse.
Lyme disease patients and their advocates are pushing for a bill that requires insurance companies to cover long-term antibiotic care for the debilitating illness. The bill highlights a debate in the medical community about the most effective treatment, because it sanctions a medical practice that critics say is not recommended by state and federal agencies.
Scientists Leaving Labs and Heading for Cubicles
Young biomedical researchers are increasingly heading away from basic research labs because of reduced funding, experts say. The NIH started a pilot effort to broaden their outside career awareness. So long, laboratory, hello cubicle. Fading research funds amid a federal budget fight may signal the disappearance of the days of the lone medical researcher making brilliant discoveries, research experts warn. The funding shortage is shunting more young scientists away from the labs that perform basic research in biology or other disciplines, the traditional home for newly minted Ph.D.’s. Instead they are increasingly headed to industry jobs that offer steady hours but forgo the thrill of making discoveries.
Agendia Took Gamble on FDA Approval for Breast-Cancer Test
Irvine-based Agendia complains that while it spent huge amounts of time, energy and resources to gain formal approval from U.S. Food and Drug Administration for its breast-cancer test, its chief rival, Genomic Health Inc., has chosen to bypass federal regulation.
FDA approval is not required for laboratory-developed tests such as Mammaprint and Oncotype DX. However, the lack of direct regulation is a "recognized problem" that the FDA is seeking to address, said Alberto Gutierrez, head of the agency's office of In Vitro Diagnostics and Radiological Devices. He said the FDA has drafted guidelines that would require FDA approval for these tests and, if approved, they could be adopted "in the near future."
FDA oversight, and the periodic inspections that go with it, means Agendia is constrained in what it can do and say while Genomic Health is not subject to similar limitations, says Agendia's CEO, David Macdonald. "What they consider evidence would likely not pass muster with the FDA," he fumes.
Not Every Woman Should get the BRCA Gene Test, U.S. Task Force Says
Certain mutations in the BRCA1 and BRCA2 genes can increase a woman's chances of developing breast cancer or ovarian cancer dramatically. But that doesn't mean all women should line up for laboratory testing to see if they have those risky versions of the genes, members of a government panel said. Unless she has a family history that makes it likely she has the harmful mutations, a woman will be unlikely to benefit from genetic counseling and genetic tests, the U.S. Preventive Services Task Force wrote, in an updated draft recommendation on screening for BRCA-related cancer risk.
HPV Testing and Cancer: Will E6/E7 Change the Paradigm?
DNA testing for HPV has become a useful addition for women with abnormal Pap results. HPV DNA tests have excellent sensitivity (around 95%) for CIN2 or higher, but specificity is low (ranging in the 20s and 30s). Because persistent HPV infections cause nearly all cervical cancer, a negative HPV DNA test result helps rule out possible cervical cancer development within the next few years. However, since most women have self-resolving HPV infections that will not develop into cancer, a positive HPV test result provides little actionable information.
E6E7 mRNA are precursors to E6E7 oncoproteins, which are functional biological molecules and more directly relevant to disease progression. Use of new markers, specifically E6 and E7 oncoproteins, may help to more accurately assess cervical cancer risk in HPV-infected women, and E6E7 immunoassays are expected to become a valuable new addition to the current testing “toolkit.” In the future, E6E7 immunoassay technology may also be applied to anal, oral, and other HPV-related cancers, which lack an effective diagnostic test and affect both women and men.
Newly Identified Genetic Variations May Help Screen for Cancers
U.K. scientists have found more than 80 new genetic variations linked to increased risk of developing cancer, which may eventually help with screening tests to warn of the disease at an earlier stage. While each alteration raises the risk of cancer by a small amount, those who carry a combination of them could see their risk of developing prostate cancer increase by almost 50 percent and breast cancer by 30 percent, according to scientists at the University of Cambridge and The Institute of Cancer Research, London. The new research increases understanding of genetic risk factors that are linked to more than half of all cancers, with the rest caused by lifestyle factors. It may also pave the way for gene-based screening tests using saliva samples, according to Paul Pharoah, cancer epidemiologist at the University of Cambridge.
Blood Assay Used for CSF Detection in Fungal Meningitis
Use of a test approved for detection of fungal infection in the blood to test the cerebrospinal fluid (CSF) has been successful in diagnosing fungal meningitis in the current outbreak caused by contaminated steroids, a new study shows. Lead investigator of the study, Jennifer Lyons, MD, Johns Hopkins School of Medicine, Baltimore, Maryland, said the test would help doctors make a more certain diagnosis of fungal meningitis in patients who have been exposed to the contaminated steroids.
Friedewald-derived LDL Misclassifies Patients at Low End of LDL Spectrum
The standard method of estimating LDL-cholesterol levels using the Friedewald equation underestimates them, particularly when triglyceride levels are high, according to the results of a new study. Researchers found that the equation misclassifies patients with very low LDL-C levels, with nearly one in four individuals with an LDL-C level <70 br="" cholesterol="" directly="" dl="" having="" higher="" it="" ldl="" levels="" measured="" mg="" of="" ultracentrifugation.="" using="" was="" when="">70>
"For a doctor seeing a patient, the target of less than 70 mg/dL is important because this is where we're going to be targeting patients deemed at high risk," said lead investigator Dr. Seth Martin (Johns Hopkins Ciccarone Center for the Prevention of Heart Disease, Baltimore, MD). "This is someone who has been in the hospital with a heart attack or someone who has diabetes and other cardiovascular risk factors, for example. We treat these high-risk patients, on the basis of PROVE-IT, TNT, and IDEAL, down to less than 70 mg/dL. But it happens to be that the formula [for estimating LDL cholesterol] breaks down at this level. Just where you want it to work the best, it actually does the opposite and works the least well."
Blood Test Lab Can Be Implanted Under Skin
EPFL scientists have developed a tiny, portable personal blood testing laboratory: a minuscule device implanted just under the skin provides an immediate analysis of substances in the body, and a radio module transmits the results to a doctor over the cell phone network. This feat of miniaturization has many potential applications, including monitoring patients undergoing chemotherapy.
Blood Test Might Spot Pancreatic Cancer Early, Study Finds
But not earl enough to make a big difference in survival rates, an expert says.
A new blood test that detects deadly pancreatic cancer earlier than usual might slightly improve patients' odds for survival, a small Japanese study suggests. "This new diagnostic test may be a safe and easy screening method that could improve the prognosis of patients with pancreatic cancer through earlier detection," said lead researcher Dr. Masaru Yoshida, an associate professor in the division of metabolomics research at Kobe University Graduate School of Medicine. "A drop of blood contains a lot of information." The new approach relies on metabolomics technology, an emerging science that focuses on small molecules. The blood test measures byproducts of metabolism, called metabolites, found in the blood.
A simple saliva test could be an effective method in predicting aggressive behavior in boys, a new study suggests. The findings, published in the journal Psychiatric Quarterly, was led by Cincinnati Children's Hospital Medical Center and reveal a direct link between salivary concentrations of certain hormones and aggression. A group of researchers led by Drew Barzman, MD, a child and adolescent forensic psychiatrist at Cincinnati Children's, gathered saliva samples from 17 young boys aged 7 to 9 years who were admitted to the hospital for psychiatric care.
A Simple Urine Test Could Be Used to Calculate How Long a Person Will Live
The findings, which were published in the National Kidney Foundation's American Journal of Kidney Diseases, reveal that healthy people have very low levels of protein in their urine as their kidneys are able to retain most of it for the body. For those with proteinuria, or excess protein in urine, it is an indicator that the kidneys have been damaged in some way, and some of the protein leaks through. According to lead author of the report, Dr. Tanvir Chowdhury Turin of the University of Calgary: "Our report shows that both men and women with higher levels of proteinuria had substantially reduced life expectancy in comparison to people with relatively low levels of proteinuria."
Common Test for Measuring Mercury: May Overestimate Exposure From Dental Amalgam Fillings
Scientists agree that dental amalgam fillings slowly release mercury vapor into the mouth. But both the amount of mercury released and the question of whether this exposure presents a significant health risk remain controversial. Public health studies often make the assumption that mercury in urine (which is composed mostly of inorganic mercury) can be used to estimate exposure to mercury vapor from amalgam fillings. These same studies often use mercury in hair (which is composed mostly of organic mercury) to estimate exposure to organic mercury from a person's diet.
But a U-M [University of Michigan] study that measured mercury isotopes in the hair and urine from 12 Michigan dentists found that their urine contained a mix of mercury from two sources: the consumption of fish containing organic mercury and inorganic mercury vapor from the dentists' own amalgam fillings. "These results challenge the common assumption that mercury in urine is entirely derived from inhaled mercury vapor," said Laura Sherman, a postdoctoral research fellow in the Department of Earth and Environmental Sciences and lead author of a paper in the journal Environmental Science & Technology. A final version of the paper has been published online.
Researchers Develop New Real-Time Technique for Monitoring Individual Red Blood Cells
Biomedical engineers from [Washington University] in St. Louis have developed a novel technique to image oxygen levels in individual cells in real-time. The technique, called photoacoustic flowoxigraphy, uses two laser pulses of different frequencies fired 20 microseconds apart to identify the color of a red blood cell, which identifies it’s oxygenation at a given instant in time.
Urine Biomarker Combo Predicts Prostate Cancer
A combination of 2 urine-based genetic biomarkers predicts prostate cancer better than either biomarker alone and better than the standard serum prostate-specific antigen (PSA), according to a new study. The 2 markers, PCA3 and the TMPRSS2: ERG gene fusion "can help stratify men for risk of cancer, significant cancer, and high-grade cancer at biopsy," said Jack Groskopf, PhD, director of oncology research and development at Hologic Gen-Probe in San Diego, California. The company is currently developing both biomarkers.
HPV Test Gets Thumbs Up in Cervical Cancer Screening
The next step after an indeterminate Pap smear should usually be human papillomavirus (HPV) testing rather than a second cervical cytology swipe, a Cochrane review affirmed. The virologic test had 27% better sensitivity and equal specificity in detecting high-grade cervical precancers in women with an initial finding of the most common type of abnormality on cervical cancer screening (P<0 .0001="" and="" arbyn="" br="" brussels="" colleagues="" found.="" health="" in="" institute="" marc="" md="" msc="" of="" public="" scientific="" the="">0>
Today’s white blood cell counters (WBC) are bulky machines that often require large blood samples and can take hours for a simple output. Furthermore, differential WBC count is often done manually, by a human being, so the results can take a day or so. Researchers from Caltech and Jerusalem, Israel-based LeukoDx seem to be on the right track having developed a prototype WBC system that uses only 5 μL of blood and spits out results in minutes. It’s currently the size of a briefcase, but the team claims it could be made much smaller. The device counts all five white blood cell subtypes and provides a differential on the four most common ones. Purportedly it can also detect very high levels of the fifth, basophil granulocytes, which is normally quite rare in blood and hard to detect.
New Cancer Diagnostic Technique Debuts
Scientists devise a molecular sensor that can detect levels of lactate in individual cells in real time. Cancer cells break down sugars and produce the metabolic acid lactate at a much higher rate than normal cells. This phenomenon provides a telltale sign that cancer is present, via diagnostics such as PET scans, and possibly offers an avenue for novel cancer therapies. Now a team of Chilean researchers at The Centro de Estudios Científicos (CECs), with the collaboration of Carnegie’s Wolf Frommer, has devised a molecular sensor that can detect levels of lactate in individual cells in real time.
In addition, the biosensors promise to solve an old controversy. While some studies have suggested the glucose provides the fuel for the brain, recent research has provided evidence that lactate feeds energy metabolism in neurons. Oxidation of lactate can be used to produce large amount of ATP—the coenzyme that carries energy in cells. The Barros and Frommer teams are excited about the solving this enigma with the use of their new sensors, together with the previously developed glucose sensors.
What is The Best Way to Screen for MRSA?
Researchers recently evaluated nasal swabs against swabs from a number of body sites to determine how effective nasal swabbing is for MRSA screening. The gold standard was determined to be the sum of all the positive cultures from nasal, throat, axillary and perineal screening. The best was nasal screening which yielded 60 %. Nasal and perineal screening was the best combination with 82 % of all the positives. Axillary screening was the worst.
Source: http://www.questdiagnostics.com/ [PDF 2.13MB]
Link Discovered Between Blood Clotting and Immune Response
Rice University researchers have found an unexpected link between a protein that triggers the formation of blood clots and other proteins that are essential for the body's immune system. The find could lead to new treatments for thousands of patients who suffer from inflammatory diseases and disorders that cause abnormal blood clotting. The research is available online in the journal PLOS ONE.
"This link opens the door for studying severe, debilitating inflammatory disorders where the disease mechanism is still poorly understood, including lupus, rheumatoid arthritis, regional ileitis and ulcerative colitis, as well as age-related macular degeneration," said study co-author Dr. Joel Moake, a hematologist and senior research scientist in bioengineering at Rice.
Drchrono Digitizes Patient Education for Mayo Clinic
Although many doctors' offices still have stacks of paper pamphlets for patients to grab on the way out, Mayo Clinic has found a way to digitize these resources. A nonprofit health system and a leader in health research and education, the organization is using Drchrono's electronic health record (EHR) application for the iPad to distribute these materials to patients without paper. Doctors have access to a real-time data stream of Mayo Clinic content they can select to share with patients on the iPhone, iPad or on the Web. More than 2,600 educational documents and more than 300 videos provide information to patients about their diagnoses or procedures they may have to undergo
Sequencing is No Longer a Sleeping Controversy
Muin J Khoury, Director, Office of Public Health Genomics, CDC writes that advances in whole genome sequencing (WGS) promise to reveal fundamental information about our risks for various diseases. By definition WGS includes an enormous amount of data: six billion base pairs in a human’s genome. Unfortunately, we do not yet know what to do with the great majority of these data points, a fact that will become even more important in the next decade. Two publications have now raised awareness of the potential controversies associated with the anticipated integration of WGS into clinical and public health practice. The most recent was the American College of Medical Genetics report ACMG Recommendations for Reporting of Incidental Findings in Clinical Exome and Genome Sequencing. The report argued that persons whose genomes are sequenced for any medical reason should be informed, via their healthcare providers, about variants in 57 genes that put them at risk of preventable diseases – a form of “opportunistic screening”. The second article is a commentary in the journal Genetics in Medicine entitled: We Screen Newborns Don’t We? Realizing, the Promise of Public Health Genomics. James Evans and coauthors argue for a public health approach to assess the feasibility of active population screening for selected rare genomic variants to find millions of affected people who are at risk of preventable diseases such as cancer and heart disease – a model not too dissimilar from newborn screening.
The 50-Hour Genome
What Does This Technical Feat Spell for Clinical Laboratories?
Scientists at Children’s Mercy Hospital (CMH) in Kansas City recently reported being able to perform whole genome sequencing (WGS) and provide a provisional genetic diagnosis within 50 hours, far faster than the more typical 4- to 6-week or even longer sequencing and analysis cycle. This landmark proof-of-concept study gained world-wide attention and unquestionably moved the genomics field closer to making WGS practical for everyday clinical use. However, experts and even the research team itself caution that there are miles to go and many hurdles to clear before rapid WGS becomes a routine component of medical care. Even so, clinical laboratorians will do well to keep abreast of this fast-moving field so they can navigate the coming genomic world successfully.
Houston Study Augurs Possible Shift in hrHPV Genotypes
First identified in an HIV patient in 1998, HPV 90 is a genotype of the human papillomavirus that, until now, has received little attention. It is not counted as one of the few well-defined high-risk genotypes, like HPV 16 and HPV 18, that are known to cause the majority of cervical cancer cases. But after studying data from 808 mostly Latina women patients, pathologists at The Methodist Hospital in Houston recently made surprising discoveries that are likely to raise HPV 90’s profile. HPV 90, these researchers found, may be not only more prevalent than previously thought but also a genotype associated with cervical intraepithelial lesions.
Scientists Reveal Quirky Feature of Lyme Disease Bacteria
Unlike most organisms, they don't need iron, but they crave manganese.
Scientists have confirmed that the pathogen that causes Lyme Disease—unlike any other known organism—can exist without iron, a metal that all other life needs to make proteins and enzymes. Instead of iron, the bacteria substitute manganese to make an essential enzyme, thus eluding immune system defenses that protect the body by starving pathogens of iron.
Bacteria in the Intestines May Help Tip the Bathroom Scale, Studies Show
The bacterial makeup of the intestines may help determine whether people gain weight or lose it, according to two new studies, one in humans and one in mice. The research also suggests that a popular weight-loss operation, gastric bypass, which shrinks the stomach and rearranges the intestines, seems to work in part by shifting the balance of bacteria in the digestive tract. People who have the surgery generally lose 65 percent to 75 percent of their excess weight, but scientists have not fully understood why. Now, the researchers are saying that bacterial changes may account for 20 percent of the weight loss. The findings mean that eventually, treatments that adjust the microbe levels, or “microbiota,” in the gut may be developed to help people lose weight without surgery, said Dr. Lee M. Kaplan, director of the obesity, metabolism and nutrition institute at the Massachusetts General Hospital, and an author of a study published in Science Translational Medicine.
Scientists at the Food and Drug Administration systematically monitor the meat and poultry sold in supermarkets around the country for the presence of disease-causing bacteria that are resistant to antibiotics. These food products are bellwethers that tell us how bad the crisis of antibiotic resistance is getting. And they’re telling us it’s getting worse. In 2011, drugmakers sold nearly 30 million pounds of antibiotics for livestock — the largest amount yet recorded and about 80 percent of all reported antibiotic sales that year. The rest was for human health care. We don’t know much more except that, rather than healing sick animals, these drugs are often fed to animals at low levels to make them grow faster and to suppress diseases that arise because they live in dangerously close quarters on top of one another’s waste.
The Senate committee recently approved the Animal Drug User Fee Act, a bill that would authorize the F.D.A. to collect fees from veterinary-drug makers to finance the agency’s review of their products. Public health experts had urged the committee to require drug companies to provide more detailed antibiotic sales data to the agency. Yet the F.D.A. stood by silently as the committee declined to act, rejecting a modest proposal from Senators Kirsten E. Gillibrand of New York and Dianne Feinstein of California, both Democrats, that required the agency to report data it already collects but does not disclose. In the House, Representatives Henry A. Waxman of California and Louise M. Slaughter of New York, also Democrats, have introduced a more comprehensive measure. It would not only authorize the F.D.A. to collect more detailed data from drug companies, but would also require food producers to disclose how often they fed antibiotics to animals at low levels to make them grow faster and to offset poor conditions.
The Healthcare System's Perfect Storm
The clinical laboratory community faces changes and strategic challenges
The nation's healthcare system—and with it, the clinical laboratory community—has entered its own perfect storm period. So many changes are underway, and a number of challenges continue to await solutions. As a result, we have entered a period in which fundamental transformation is unavoidable. In just a few short years, the healthcare system, and the patient experience, will seem remarkably different than it does now.
Among the changes and strategic challenges in play:
- Affordable Care Act implementation
- Budget pressures
- Emergence of new healthcare delivery and cost savings models
- The rise of retail medicine
- Electronic Medical Records (EMR)
- Fewer regulated tests
- Workforce challenges:
Most Physicians Concerned About Future of Profession
Nearly 6 in 10 physicians in a Deloitte Center for Health Solutions survey said they are concerned about the future of medicine, pointing to declining clinical autonomy and income.
Pessimism among physicians resulted in nearly 75% agreeing that "the best and brightest" may avoid a career in medicine. That number increased from 69% the year before. Still, 7 in 10 physicians reported they were satisfied with their careers. The most satisfied groups were the nonsurgical specialists (67%) and physicians aged 25 to 39 (80%). Primary care physicians were the least satisfied division, at 59%.
Studies: Residents Make More Errors on Shorter Shifts
Efforts to cut back long hours for medical residents may have the unintended consequence of leading to more errors, studies say. A workplace regulation designed to limit hours worked by doctors in training to improve patient safety and enhance medical residents' well-being has backfired and needs to be re-evaluated, according to two reports out. At the heart of both studies appearing in the Journal of the American Medical Association is the length of time a young doctor is allowed to work without taking a break. A medical oversight board decreased that time from 30 hours to 16 in 2011 in part to "protect patients from errors made by sleepy doctors,'' according to a study done at the University of Michigan Medical School.
Those researchers say the shorter shift has not improved young doctors' depression rates or how long they sleep. Most concerning: Medical errors harming patients increased 15% to 20% among residents compared with residents who worked longer shifts. "Teaching hospitals haven't invested in providing extra help to shoulder any of the clinical work that has to be done,'' says physician Elizabeth Wiley, president of the American Medical Student Association, who is not associated with the study. "It could be the interns are required to do the same amount of work in less time."
Five More Physicians Indicted in Massive Fraud Case
The mastermind behind a massive healthcare fraud scheme centered in Detroit, Michigan, is behind bars, but the roundup of underlings continues with the recent federal indictment of 5 more physicians and 4 more pharmacists in the case. In February, pharmacist Babubhai "Bob" Patel, RPh, was sentenced in a federal district court to 17 years in prison for running an operation that submitted nearly $20 million worth of fraudulent prescription claims to Medicare, Medicaid, and private insurers over 5 years in addition to illegally distributing millions of opioid painkillers and other controlled substances. Patel bribed physicians to write medically unnecessary scripts and steer patients to fill them at one of his 26 pharmacies.
Health officials in the US state of Oklahoma have warned 7,000 patients their dentist may have exposed them to HIV and hepatitis B and C. Patients of Dr W. Scott Harrington's practice in Tulsa were advised to test themselves at a free clinic set up by the state, health officials said. Health inspectors found rusty dental instruments and poor hygiene standards at the clinic. Dr Harrington has voluntarily closed the practice, officials said.
Reports of Hospital Mistakes Now Available Online
Hospitals make mistakes. When they are reported — by patients, employees or family members — state and federal officials investigate. Now, for the first time, the U.S. Centers for Medicare and Medicaid (CMS) has released those inspection reports for hospitals nationwide from the past two years. The release was in response to requests from the Association of Health Care Journalists, which has compiled them into a searchable database available to the public. CMS collects the reports for all hospitals that receive payments from Medicare or Medicaid. There are no fines for violations, but the federal government can terminate a hospital's Medicare agreement if it does not correct problems. Twelve states already put hospital complaint investigations online
Vendor Misconceptions Hamper EHR Usability
Usability is often where blame is directed for physicians' dissatisfaction with their electronic health record systems. The problem, says Nancy Staggers, PhD, RN, and Lorraine Chapman, is that vendors have misconceptions about what physicians want or need from their EHRs and what makes them easy to use. These misconceptions are what they refer to as EHR “usability myths.”
A survey by American EHR Partners of 4,279 clinicians, including primary care physicians, specialists and diagnostic professionals, found that EHR user satisfaction declined from 39% in 2010 to 27% in 2012.
BlackBerry 10 to Hit Market With Array of Health Care Apps
- Viewing Radiology Images
- A Mobile Drug Reference Tool
- Health Tracker for Monitoring Fitness
- Keeping Your BMI Out of Danger
- A Government Resource on Drugs and Health Topics
- A Guide to Drug Interactions
- Express Viewing of Health Records and Images
- A Drug Resource for Nurses
- A Clinical Calculator and Decision-Support Tool
- A Mobile Guide to Diseases and Medical Calculations
Researchers in Spain Set Sights on Lab-grown Heart
Since a laboratory in North Carolina made a bladder in 1996, scientists have built increasingly more complex organs. There have been five windpipe replacements so far. A London researcher, Alex Seifalian, has transplanted lab-grown tear ducts and an artery into patients. He has made an artificial nose he expects to transplant later this year in a man who lost his nose to skin cancer.
Now, with the quest to build a heart, researchers are tackling the most complex organ yet. The payoff could be huge, both medically and financially, because so many people around the world are afflicted with heart disease. Researchers see a multi-billion-dollar market developing for heart parts that could repair diseased hearts and clogged arteries.
46 Gene Sequencing Test for Cancer Patients on the NHS
The first multi-gene test that can help predict cancer patients' responses to treatment using the latest DNA sequencing techniques has been launched in the NHS. The test detects mutations across 46 genes in cancer cells, mutations which may be driving the growth of the cancer in patients with solid tumours. The presence of a mutation in a gene can potentially determine which treatment a patient should receive.
The new £300 test could save significantly more in drug costs by getting patients on to the right treatments straightaway, reducing harm from side effects as well as the time lost before arriving at an effective treatment.
Mercy Ships Delivers High-Tech Healthcare to West Africa From Floating Hospital
Built specifically for medical missions, the 499-foot Africa Mercy includes six state-of-the-art operating rooms, as well as intensive care and bed space for up to 78 patients. It can house a staff of 484 including highly skilled surgeons, specialists and other medical personnel who volunteer their services. During a recent 10-month port visit to Sierra Leone, volunteer professionals performed 3,300 life-changing general surgeries, over 2,600 eye surgeries, more than 34,700 dental treatments and approximately 10,000 medical consultations. In addition, more than 450 local healthcare professionals were trained in their area of expertise – anesthesiology, orthopedic and reconstructive surgery, midwifery and eye surgery.
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