A Weekly Compilation of Clinical Laboratory and Related Information
from The Division of Laboratory Science and Standards
July 11, 2013
- FDA Clears CDC Panel for Human Influenza Virus
- The Gap in Medical Testing
- Many Docs Don't Follow HPV/Pap Test Guidelines: Study
- Rethinking Cholesterol
- Now, Device That Detects Presence of Bacteria Within Minutes
- The Test that can 'Smell' Bladder Cancer Long Before Symptoms Develop
- Next-Gen Sequencing Child Born
- WHO Sets up Emergency Committee on MERS Virus
- A Disease Without a Cure Spreads Quietly in the West
- Just one in Three US Patients has Control of BP and Cholesterol
- HHS Issues Final Health IT Safety Plan
- Health IT Funding Boost Needed To Enhance CDC's Infection Tracking Network
View Previous Issues - Healthcare News Archive
FDA Clears CDC Panel for Human Influenza Virus
The US Food and Drug Administration has given 510(k) clearance to the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel. The test, which was modified to use an alternative enzyme, the Quanta BioSciences qScript One-Step qRT-PCR Low ROX, is intended for use on Life Technologies' Applied Biosystems' ABI 7500 Fast Dx Real-Time PCR instrument. It comprises oligonucleotide primers and TaqMan probes for use in rRT-PCR for the in vitro qualitative detection and characterization of human influenza viruses from viral RNA respiratory specimens from patients with illnesses resembling influenza. Specifically, the test is for the qualitative detection of influenza virus type A or B from viral RNA in patients with signs and symptoms of respiratory infection and/or from viral culture, FDA said. It also is for determining the subtype of seasonal human influenza A viruses as seasonal A/H1, A/H3, and/or A/H1pdm09 from viral RNA in patients; the presumptive identification of virus in patients who may have influenza A subtype A/H5; and to provide epidemiological information for surveillance of circulating influenza viruses.
The Gap in Medical Testing
An alarming number of diagnostic medical tests have never been tested for safety and accuracy. That’s because the federal government has a two-tier system for regulating such tests. If a diagnostic test is made by a traditional device manufacturer, the Food and Drug Administration reviews its safety and effectiveness before approving it for marketing. However, if a test is developed by a clinical laboratory for use at its own facilities, it can be sold without a premarket review.That bifurcated approach made sense in years past when a medical center might develop a diagnostic test for its own doctors and patients. But the landscape has changed with the advent of more sophisticated tests and the rapid expansion of commercial laboratory companies. Experts are unsure about how well these so-called laboratory-developed tests, or L.D.T.’s, perform in identifying diseases.
Medical Device Tax: Congressional duo Launches tax Reform Tour
Medtech groups laud Sen. Max Baucus (D-Mont.) and Rep. Dave Camp (R-Mich.) for their U.S. tax reform tour, which the industry hopes may become a vehicle for repealing the 2.3% medical device tax. Medical device industry lobbying groups rallied behind Sen. Max Baucus (D-Mont.) and Rep. Dave Camp (R-Mich.) as the Congressional duo embarked on a nation-wide tax reform tour, a possible boon to efforts to repeal the medical device tax. Baucus, who is chairman of the Senate Finance Committee, and Camp, chairman of the House Ways & Means Committee, launched the tour with a stop in Minnesota, where they visited the Maplewood headquarters of 3M Co.
Crucial Rule is Delayed a Year for Obama’s Health Law
In a significant setback for President Obama’s signature domestic initiative, the administration abruptly announced a one-year delay, until 2015, in his health care law’s mandate that larger employers provide coverage for their workers or pay penalties. The decision postpones the effective date beyond next year’s midterm elections. “We have heard concerns about the complexity of the requirements and the need for more time to implement them effectively,” Mark J. Mazur, an assistant Treasury secretary, wrote on the department’s Web site.
DNA Interpretation for the Courts
University College London's David Balding argues in the Proceedings of the National Academy of Sciences that the statistical methods used to evaluate noisy, mixed-source, low-template DNA profiles have "serious shortcomings." Such profiles, he notes, have been used in court cases in the UK and in Italy, where the methods become the center of controversy, such as in the trial of Amanda Knox, New Scientist notes. Balding instead proposes a new method, called likeLTD, that calculates a likelihood score that certain people contributed to crime scene DNA samples. The calculation takes different drop-out and drop-in rates, different amounts of DNA from different contributors, degradation, and more into consideration.
Synthetic biologists are evaluating the merits of alternatives to patent protection for their products, exploring such options as copyrights and open-source patent registries, Nature News reports. Members of the community are trying to eliminate the legal barriers that limit the use of biological parts particularly by small startups for which "the intellectual-property situation … is just a nightmare," Claes Gustafsson, DNA2.0's chief commercial officer tells Nature.
WHO Sets up Emergency Committee on MERS Virus
The World Health Organization is forming an emergency committee of international experts to prepare for a possible worsening of the Middle East coronavirus (MERS), which has killed 40 people, WHO flu expert Keiji Fukuda said. Fukuda said there was currently no emergency or pandemic but the experts would advise on how to tackle the disease if the number of cases suddenly grows. Most of the cases of MERS so far have been in Saudi Arabia, which hosts millions of Muslim visitors every year for the annual haj pilgrimage. "We want to make sure we can move as quickly as possible if we need to," Fukuda told a news conference.
Labs are Vital Program Moves Into Community Hands
A consortium comprised of international laboratory professional bodies has formed to build on the success of Abbott’s Labs Are Vital program. The goals of the program remain the same: to emphasize the critical role that laboratory professionals play in improving patient care, and to raise the profile of laboratory medicine as an attractive career choice. A new Members Board has been formed to achieve these goals. It is made up of representatives from IFCC (International Federation of Clinical Chemistry and Laboratory Medicine), WASPaLM (World Association of Societies of Pathology & Laboratory Medicine), ASCP (American Society of Clinical Pathology), and IFBLS (International Federation for Biomedical and Laboratory Science).
Many Docs Don't Follow HPV/Pap Test Guidelines: Study
Too few doctors follow U.S. guidelines for human papillomavirus (HPV) vaccination and cervical cancer screening, according to a new study. A survey of 366 obstetricians-gynecologists in the United States found that less than one-third of them vaccinate eligible patients against HPV and only half follow cervical cancer prevention guidelines. Vaccination against HPV -- which can cause cervical cancer -- is recommended for females aged 11 to 26 years.
Most patients think of cholesterol in two forms -- low density lipoproteins (LDL) and high density lipoproteins (HDL). LDL has always been associated with higher risk for cardiovascular disease (CVD) because of its tendency to easily attach to artery walls, causing atherosclerosis. But recent research strengthens the case for measuring a third component -- low density lipoproteins particles (LDL-P) -- as a driver of plaque buildup and stronger biomarker of CVD risk. LDL particle number and LDL cholesterol (LDL-C) are not the same. LDL particles are containers that transport cholesterol through the bloodstream and deposit their contents on the artery wall, causing plaque formation," said Deanna Franke, PhD, board-certified clinical chemist and laboratory director of LipoScience. LDL-P size also matters, as smaller, denser particles are more easily deposited in sub-endothelial area where plaque builds. They may also be more easily oxidized, contributing to atherogenesis. People with a predominance of these small, dense particles may be at a 300% percent greater risk for heart disease than those with larger, lighter LDL particles.
Now, Device That Detects Presence of Bacteria Within Minutes
Scientists have developed a matchbox-sized device that can test for the presence of bacteria in a couple of minutes, instead of up to several weeks. The device can be used to determine if a bacteria has been effectively treated by an antibiotic, a crucial medical tool especially for resistant strains. It could also prove useful for testing chemotherapy treatment, researchers believe. It works by a nano-lever that vibrates in the presence of bacterial activity, while a laser reads the vibration and translates it into an electrical signal that can be easily read - the absence of a signal signifies the absence of bacteria. "This method is fast and accurate. And it can be a precious tool for both doctors looking for the right dosage of antibiotics and for researchers to determine which treatments are the most effective," said Giovanni Dietler from Ecole Polytechnique Federale de Lausanne (EPFL) in Switzerland.
The Test That can 'Smell' Bladder Cancer Long Before Symptoms Develop and is 100% Accurate
- Odoreader can detect the disease in a patient's urine
- Can be used by GP and gives result in 30 minutes
- Trials showed it to be 100% accurate
The 'Gold' Standard: A Rapid, Cheap Method of Detecting Dengue Virus
The development of an easy to use, low cost method of detecting dengue virus in mosquitoes based on gold nanoparticles is reported in BioMed Central's open access journal Virology Journal. The assay is able to detect lower levels of the virus than current tests, and is easy to transport and use in remote regions. Half the world's population is at risk of Dengue virus infection - it infects 50-100 million people per year, approximately half a million of these require hospitalization and 2.5% (most of which are children) will die. It is one of the most dangerous viruses in the world with no vaccine, and it does not respond to antiviral therapy. The main method of controlling infection remains destruction of the standing water where the mosquitoes, which transmit the virus to people, breed.
New Automated Test Can Accurately and Swiftly Detect Most Leading Causes of Bacterial Blood Stream Infections
A new automated diagnostic test can quickly and accurately identify most leading causes of Gram-positive bacterial blood stream infections and the presence of three antibiotic resistance genes, according to a new study published in PLOS Medicine. The findings from the study, conducted by a team of researchers led by Nathan Ledeboer from the Medical College of Wisconsin (MCW), USA, suggest that the new technology could lead to faster diagnosis and treatment of patients suffering from sepsis.
Gene Test May ID Kidney Rejection
A urine-derived three-gene signature showed potential for noninvasive discrimination of kidney grafts that are being rejected from those that are not, a study of almost 500 allograft recipients showed. An evaluation of the signature in 4,300 urine samples yielded an 85% probability (area under the curve, AUC) for distinguishing between acute rejection and lack of rejection. Analysis of an validation cohort produced a 74% probability of accuracy, which did not differ significantly from the test group.
A new palm-sized microarray that holds 1,200 individual cultures of fungi or bacteria could enable faster, more efficient drug discovery, according to a study published in mBio®, the online open-access journal of the American Society for Microbiology. Scientists at the University of Texas at San Antonio and the U.S. Army Institute of Surgical Research at Fort Sam Houston have developed a microarray platform for culturing fungal biofilms, and validated one potential application of the technology to identify new drugs effective against Candida albicans biofilms. The nano-scale platform technology could one day be used for rapid drug discovery for treatment of any number of fungal or bacterial infections, according to the authors, or even as a rapid clinical test to identify antibiotic drugs that will be effective against a particular infection.
FDA Wants to Downgrade Blood Access Devices
The FDA recommended bumping blood access devices down from Class III to Class II regulatory status, based on mounting evidence that these implanted tubes, catheters and cannulae belong in a lower-risk category. The federal watchdog agency said there's enough safety and efficacy data to peel off a layer of regulatory oversight. Unlike the highest-risk Class III category, Class II devices are subject special controls, such as labeling rules and performance standards, but are exempt from the FDA's stringent pre-market approval protocol and its attendant clinical trial requirements.
BioFire Receives FDA Clearance for the FilmArray Blood Culture Identification Panel
BioFire Diagnostics, Inc. has announced the FDA clearance of its FilmArray Blood Culture Identification (BCID) Panel. The 27-target panel provides results from positive blood cultures, and can identify more than 100 blood pathogens known to cause sepsis. The BCID Panel is designed to help hospitals identify bloodstream infection-causing organisms rapidly. Rapid identification of pathogens in positive blood cultures has been shown to reduce mortality rates, shorten hospital stays, and lower overall costs due to sepsis.
Roche Seeks Primary Screening Indication for HPV Test
Roche said that it has submitted a Premarket Approval supplement to the US Food and Drug Administration seeking the addition of a cervical cancer primary screening indication for its cobas HPV Test. If the FDA approves the indication, the cobas test could then be used as a first-line test, rather than Pap cytology, as part of a cervical cancer screening strategy, said Roche. The test was initially approved by the FDA in April 2011 to screen patients age 21 and older with abnormal Pap test results as well as to co-test with Pap in women ages 30 to 65 to assess the presence or absence of high-risk human papillomavirus genotypes.
Next Generation Sequencing (NGS) Market Worth $2.7 Billion by 2017
The global NGS market was valued at $1.3 billion in 2012 and is poised to reach $2.7 billion by 2017 at a CAGR of 16.3%. The growth of the overall NGS market is driven by continuous innovations and developments in the market aimed at higher throughput, increased accuracy, and affordable costs. The opportunities for the growth of this market include developments in pre-sequencing, cloud computing, and NGS bioinformatics solutions. However, factors such as high reliability on grants and funding from the government and decrease in capital expenditure from academic institutions are hindering the growth of the market. In addition, the interpretation of big data generated by sequencers and the subsequent storage and management of analyzed data is still a challenge. Owing to the complexity of NGS technologies and data, standardization of the overall NGS workflow is still an unmet need.
In the pageant of life, we are genetically bloated. The human genome contains around 20,000 protein-coding genes. Many other species get by with a lot less. The gut microbe Escherichia coli, for example, has just 4,100 genes. Scientists have long wondered how much further life can be stripped down and still remain alive. Is there a genetic essence of life? The answer seems to be that the true essence of life is not some handful of genes, but coexistence. In recent years, scientists have systematically shut down each of E. coli’s genes to see which it can live without. Most of its genes turn out to be dispensable. Only 302 have proved to be absolutely essential.
Researchers Develop MRI Scan to Detect Cancer Using Sugar
Scientists from University College London (UCL) have developed a technique they call glucose chemical exchange saturation transfer (glucoCEST). The work, published in the journal Nature Medicine, is based on the fact that tumors consume a higher amount of glucose compared with healthy tissues, as a way of sustaining their growth. Dr. Simon Walker-Samuel from the UCL Centre for Advanced Biomedical Imaging says: "We have developed a new state-of-the-art imaging technique to visualize and map the location of tumors that will hopefully enable us to assess the efficacy of novel cancer therapies."
New Breakthrough Brings Malaria Vaccine one Step Closer to Reality
Researchers have developed a vaccine using blood-stage malaria parasites, which were attenuated with a chemical agent that keeps the parasite from multiplying. Research has focused on the development of a vaccine to prevent the disease. However, many malaria vaccines targeting parasite antigens have failed because the antigen targets are highly variable. Based on the observation that low-density infections can induce antibody-independent immunity to different malaria strains, Michael Good and colleagues at Griffith University in Australia created the vaccine. In their report, they wrote that mice inoculated with a single species of attenuated parasite displayed immunity to multiple malaria species for over 100 days. These data indicate that vaccination with chemically attenuated parasites provides protective immunity and suggest that such vaccines could be used to target human malaria species. The study has been published in Journal of Clinical Investigation. (ANI)
Genes May Reveal When Aspirin Won't Reduce Heart Risk
People are often told to take low-dose aspirin to reduce the risk of heart attacks and stroke. But that preventive remedy doesn't work for a lot of people. Researchers say they've found genetic variations that might be used to identify people who don't respond well to aspirin. If the results prove out, there could soon be a blood test to tell who benefits from aspirin, and who needs to look for other treatments to reduce cardiovascular risk. Aspirin is prescribed because it makes the blood's platelets less sticky, and less apt to clump together and form blood clots. Clots are a key cause of both heart attacks and strokes.
Boston Researchers Report Encouraging HIV Findings
Boston researchers are reporting an intriguing finding in two of their patients with longstanding HIV infections that may bolster a new approach to fighting the disease. The Brigham and Women’s Hospital scientists say the patients, who underwent bone marrow transplants several years ago for cancer, have no detectable levels of HIV in their blood cells anymore, despite recently stopping powerful antiretroviral medications that are typically given to those infected with the virus. “I don’t want to use the ‘cure’ word,” said Dr. Timothy Henrich, a Brigham infectious diseases associate physician who is leading the study. “If they remain virus-free in a year, or even two years, after [stopping] therapy, then we can make a statement that the chances of the virus returning are very low.”
- Two proteins that allow the body to taste sweet and savoury flavours on the tongue play a vital part in sperm development
- The shock findings were made when mice were bred for taste related studies
- Molecular biologists believe that their work could help scientists develop treatments to combat infertility in men
American researchers found that two proteins, which allow the body to taste sweet and savoury flavours on the tongue, play a vital part in sperm development. The study, from the Monell Centre in Philadelphia, could suggest new ways to help male infertility or even spark the production of new male contraceptives. The surprising findings were made when mice were bred for taste related studies, without the two proteins known as taste receptors. They were found to be sterile, according to the study published in Proceedings of the National Academies of Sciences. Molecular Biologist Dr Bedrich Mosinger, said: 'This paper highlights a connection between the taste system and male reproduction.
Next-Gen Sequencing Child Born
A child has been born in the US after physicians and scientists used next-generation sequencing to select an embryo for in vitro fertilization. This birth marks the first time that sequencing has been used to screen embryos for IVF, a process that generally sees only around 30 percent of the embryos that are selected actually successfully implant, likely due to chromosomal or genetic defects. Although other genetic tests screening methods have already been introduced to identify candidate embryos, they have drawbacks, according to the European Society of Human Reproduction and Embryology. The method used to select the embryo in this case, developed by Dagan Wells of the NIHR Biomedical Research Centre at the University of Oxford, has overcome some of the current obstacles, according to ESHRE.
Stem Cells Help Grow Human Liver Tissue 'Buds' in Mice
Organ transplant tissues created from stem cells have been seen as a medical possibility for decades. An experiment with human liver stem cells points to one promising path to this kind of medicine. An international stem cell research team reports that they have grown functioning human liver tissues in mice. The human liver "buds" implanted in the mice represent a first experimental step in growing replacement organs from stem cells for transplants, such as liver, pancreas and kidneys, says the research team headed by Japan's Takanori Takebe of the Yokohama City University Graduate School of Medicine. The team relied on a "cocktail" of so-called induced stem cells grown to resemble the nascent liver bud cells used in the experiment.
Understanding the Protective Side of Dengue Virus
Infection with one strain of the dengue virus gives people protection against the other three strains for about two years, a new biostatistics study has found. That information should help researchers trying to develop vaccines against the mosquito-borne virus, which is nicknamed “break-bone fever” for the joint pain it causes. Dengue infects 5 percent of the world’s population each year, and its range is increasing. In 2009, it reappeared in the United States for the first time in 40 years. Dengue is now considered endemic to Key West, Fla.
A Disease Without a Cure Spreads Quietly in the West
Coccidioidomycosis, known as “cocci,” is an insidious airborne fungal disease in which microscopic spores in the soil take flight on the wind or even a mild breeze to lodge in the moist habitat of the lungs and, in the most extreme instances, spread to the bones, the skin, the eyes or, in Mr. Klorman’s case, the brain. The infection, which the Centers for Disease Control and Prevention has labeled “a silent epidemic,” is striking more people each year, with more than 20,000 reported cases annually throughout the Southwest, especially in California and Arizona. Although most people exposed to the fungus do not fall ill, about 160 die from it each year, with thousands more facing years of disability and surgery. About 9 percent of those infected will contract pneumonia and 1 percent will experience serious complications beyond the lungs.
A southeast Georgia resident is the first human case of West Nile virus confirmed in the state this year. The Department of Public Health said that the adult Brantley County patient was infected in May and recovered without complications and without having to be hospitalized. Nationally, the CDC has reported 10 cases of West Nile virus this year, with one death, as of July 2. It’s a virus most commonly spread by infected mosquitoes.
Just one in Three US Patients has Control of BP and Cholesterol
Less than one in three patients in the US have their blood-pressure and cholesterol levels under control, according to a new analysis of the National Health and Nutrition Examination Surveys (NHANES) . Researchers say there exist significant opportunities for reaching national coronary heart disease prevention goals by improving hypertension and cholesterol control.
"It's been known for many years that people with high blood pressure have about double the risk of coronary heart disease, but treating hypertension with the usual ways we go about it reduces heart attack risk by about 25%," lead investigator Dr Brent Egan (Medical University of South Carolina, Charleston) told heartwire. "So that leaves a lot of residual risk. While it's been known that treating multiple risk factors is more beneficial than treating any one risk factor alone, I think it might be underappreciated in terms of how important it is to treat and control both high blood pressure and cholesterol."
How Exercise Can Calm Anxiety
In an eye-opening demonstration of nature’s ingenuity, researchers at Princeton University recently discovered that exercise creates vibrant new brain cells — and then shuts them down when they shouldn’t be in action. For some time, scientists studying exercise have been puzzled by physical activity’s two seemingly incompatible effects on the brain. On the one hand, exercise is known to prompt the creation of new and very excitable brain cells. At the same time, exercise can induce an overall pattern of calm in certain parts of the brain.
Lifestyle Changes Don't Protect Diabetic Heart
An intense lifestyle intervention for patients with type 2 diabetes that was focused on diet and exercise failed to protect patients against heart problems, researchers reported. Final analysis of the randomized, controlled Look AHEAD trial, which was halted in September for failing to show cardiovascular benefit, revealed no significant differences in a composite of cardiovascular endpoints between those who had the intervention and those who only received advice (1.83 events per 100 person-years versus 1.92, P=0.51), according to Rena Wing, PhD, of Brown University, and colleagues.
High Tech Hand Washing Comes to St. Louis Hospital
A new system being tested at St. Mary’s Health Center reminds nurses to wash their hands at various checkpoints and tracks their compliance. Testing of the system, from Biovigil Hygiene Technologies of Michigan, started last year with nurses and aides in two departments at the hospital. Each nurse wears a badge that is triggered and chirps when they walk under infrared sensors placed in doorways. After the nurse uses hand sanitizer and cups his or her hand over the badge, a sensor registers fumes from the evaporating alcohol. A light on the badge then turns green to show patients and staff that hands have been cleaned. At the end of their shifts, nurses place the badges on docking stations that download the hand washing data. Hospital officials said compliance rates have risen to 99 and 97 percent in the two units.
Clinically integrated networks is one market trend in response to shift away from fee-for-service payment and toward value-based provider reimbursement One fast-developing trend is that of academic centers forming integrated networks with various providers within a community and a surrounding region. This is related to a movement to establish accountable care organizations (ACOs). But it is also a response to actions by payers to narrow their networks and exclude high-cost providers, such as academic centers. This business model has a mutual goal. Each integrated network is anchored by an academic medical center and is designed to foster closer interaction between the academic subspecialists and the wider clinical community. For pathologists and clinical lab managers, such integrated provider networks may often encourage participating physicians to send their reference and esoteric medical laboratory test referrals to the academic center and not to the physicians’ primary laboratory provider.
Docs Don't Talk About Healthcare Reform With Patients
As Affordable Care Act implementation deadlines near, physician-patient discussions often don't include healthcare reform, according to a new poll by HealthPocket. The survey of 1,176 people found that half of all respondents who have a regular physician have not talked about the ACA with him or her. For patients whose physicians have discussed healthcare reform, 38 percent heard mostly negative comments, 33 percent said their doctors made mostly positive remarks and 29 percent heard neutral comments. "Doctors, as trusted healthcare experts in the eyes of consumers, can help their patients understand how patient care will be affected," HealthPocket CEO Bruce Telkamp said in an announcement.
Some Doctors Questioning Whether Shorter Shifts for Interns Are Endangering Patients
Medical researchers at Johns Hopkins University and the University of Michigan have found that shorter shifts have resulted in greater work compression, forcing interns to cram more work into fewer hours and depriving them of valuable education by limiting the time they can spend treating patients whose illnesses evolve. A March editorial in JAMA Internal Medicine decried the new standard as "too inflexible" and warned that shorter workdays are increasing handoffs, which can cause errors as patients are transferred from doctor to doctor. "The 2011 rules have led to many unintended consequences," said Sanjay Desai, director of the internal medicine residency at Johns Hopkins Hospital, adding that the 16-hour cap "was imposed without [sufficient] data showing it would be beneficial."
Healthcare Hiring Jumps in June
Healthcare employers added nearly twice as many jobs in June as they did in May, according to the U.S. Bureau of Labor Statistics' preliminary and seasonally adjusted figures. The sector grew by 19,800 jobs for the month, still well below the 12-month average of nearly 26,000 new jobs. Overall, healthcare accounted for 10.1% of the 195,000 nonfarm payroll jobs created in June, according to the bureau's monthly report. The unemployment rate, at 7.6%, matched May's figure.
Health IT Funding Boost Needed To Enhance CDC's Infection Tracking Network
CDC has operated a health care-associated infection (HAI) tracking system for decades, first as a paper-based voluntary reporting program involving 100 hospitals and now as a Web-based system that now includes the National Healthcare Safety Network (NHSN) and the Prevention Epicenters Program, an affiliated research entity. Although the current system works reasonably well, and compiles and reports infection data from thousands of health care facilities annually, it is woefully understaffed, seriously underfunded and technologically under-powered, industry experts contend. That recognition, underscored by the disturbing economics of HAIs -- the infections increase U.S. health care expenditures by an estimated $30 billion each year- -- led to a recent request by two dozen health care organizations that Congress increase the program's annual budget to $31.5 million.
In a nutshell, Michael Bell -- deputy director of the CDC's Division of Healthcare Quality Promotion -- said that without a significant funding infusion, NHSN is ill equipped to take advantage of the health IT advances that could exponentially increase its capacity and capabilities. Bell said, "The current $12 million budget supports the program but doesn't allow for its expansion and technology we need" to streamline the system and bring into the fold the thousands of U.S. health care facilities that currently don't participate in NHSN.
HHS Issues Final Health IT Safety Plan
HHS announced that a plan to guide health information technology activities across its units, meant to eliminate medical errors, protect patients, and improve the quality and efficiency of health care, is now available. The final Health IT Patient Safety Action and Surveillance Plan "builds on recommendations from the 2011 Institute of Medicine report, titled Health IT and Patient Safety: Building Safer Systems for Better Care, and from public comments," according to its announcement. "When implemented and used properly, health IT is an important tool in finding and avoiding medical errors and protecting patients," said National Coordinator for Health IT Dr.Farzad Mostashari. "This plan will help us make sure that these new technologies are used to make health care safer."
Health IT and Patient Safety
Health IT makes possible enormous improvements in health care quality and safety, compared to paper records. Yet if not designed and used correctly, it can also introduce new risks of harm. While recent years have seen rapid growth in the adoption of electronic health records (EHRs) and health information exchange (HIE), much remains unknown about the role of health IT as both a cause of and means to preventing patient harm. Health IT can only fulfill its enormous potential to improve patient safety if the risks associated with its use are identified, if there is a coordinated effort to mitigate those risks, and if it is used to make care safer.
Plan to Scan
The recent push to an electronic medical record incentivized by billions of Federal stimulus dollars has revealed the enormous complexity of our data systems and the risk of investing in evolving technology. But The Huffington Post website reports, "health policy experts agree that phasing out paper medical charts could revolutionize healthcare." Converting paper to pixels is a big part of this effort, and something you should start doing in your laboratory, too. It's high time to plan to scan.
UK Pumps $30M Into Health Informatics Institute
The UK's Medical Research Council will invest £20 million ($30.5 million) in capital funding to create a new multicenter informatics research institute that will support the use of patient and research data, the Minister for Science and Universities David Willetts said. The Farr Institute, named after medical statistician William Farr, will have major centers in London, Dundee, Manchester, and Swansea, and will link together 19 UK universities in a network. It will build upon an existing cluster of four e-health informatics centers that already has received £19 million from government research councils and charities. The idea is to share expertise and resources across disciplines to scale up the UK's health informatics capabilities for clinical care and research.
New European Hypertension Guidelines Released: Goal is Less Than 140 mm Hg for all
Like the 2007 guidelines, patients can be stratified into four categories: high-normal blood pressure (130-139 systolic or 85-89 mm Hg diastolic), grade 1 hypertension (140-159 systolic or 90-99 diastolic mm Hg), grade 2 hypertension (160-179 systolic or 100-109 mm Hg diastolic), or grade 3 hypertension (>180 systolic or >110 mm Hg diastolic). The presence or absence of other cardiovascular risk factors or organ damage/disease should be then factored into treatment decisions for the management of blood pressure (a full risk-assessment algorithm is included in the guidelines). Fagard said the new guidelines also make a host of lifestyle recommendations for lowering blood pressure. He said they are recommending salt intake of approximately 5 to 6 g per day, in contrast with a typical intake of 9 to 12 g per day. A reduction to 5 g per day can decrease systolic blood pressure about 1 to 2 mm Hg in normotensive individuals and 4 to 5 mm Hg in hypertensive patients, he said.
South Asians (from India, Pakistan, Bangladesh) may have to exercise more than white Europeans to achieve the same levels of fitness and reduce their risk of diabetes. Researchers at the University of Glasgow have found that lower fitness levels in middle-aged men of South Asian origin are contributing to higher blood sugar levels and increased diabetes risk compared with white men. The research, published in Diabetologia, the journal of the European Association for the Study of Diabetes (EASD), suggests that physical activity guidelines may need to be changed to take ethnicity into account.
Kampala Laboratories do not Meet Standards
At the Ntinda New Market, there are at least four clinical laboratories. They are housed in tiny rooms, not larger than eight by 10 feet, while the testing area can hardly accommodate a microscope and the person operating it. Some of the laboratories have ‘registration’ placards hanging on their walls; an indication that they were surveyed and do meet standards. It is not uncommon to find such small laboratories in markets, slums or any untidy surrounding around Kampala usually testing for common diseases such as malaria, typhoid or HIV.
Disclaimer- The information provided in this news digest is intended only to be general summary information. It does not represent the official position of the Centers for Disease Control and Prevention and is not intended to take the place of applicable laws or regulations.
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