viernes, 27 de junio de 2014



Healthcare News

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


June 26, 2014

  • Making the Most of Lab Data: CDC Report Cites Laboratorians’ Unique Role in Optimizing EHRs for Patient Safety
  • Routine Vitamin D Testing Not Justified, Panel Says
  • AACC Urges NY to Rescind Blood Glucose Meter Policy
  • Researchers Offer Guidance on Clinical use of Genomic Tests
  • With Time, Greater Clarity on HPV Screening
  • New DNA Blood Test Can Better Identify Rejection After a Heart Transplant
  • In Single Gene, a Path to Fight Heart Attacks
  • Diabetes Gene 'Raises risk tenfold'
  • New Attack on Drug-resistant Bugs
  • Health System Report Ranks UK First, US Last
  • Recommendations Address Long-Term Needs of Prostate Cancer Survivors
  • Ebola Epidemic ‘Out of control’ in West Africa: Report
  • Could Big Data Become Big Brother?


View Previous Issues - Healthcare News Archive


Leading News

Making the Most of Lab Data: CDC Report Cites Laboratorians’ Unique Role in Optimizing EHRs for Patient Safety
The Centers for Disease Control and Prevention (CDC) in May released a comprehensive document that describes the critical role laboratorians can and should play in implementing and improving electronic health record (EHR) systems nationwide. The 20-page report, “The Essential Role of Laboratory Professionals: Ensuring the Safety and Effectiveness of Laboratory Data in Electronic Health Record Systems,” was produced by the Division of Laboratory Programs, Standards and Services in CDC’s Center for Surveillance, Epidemiology and Laboratory Services in response to EHR-related patient safety risks articulated by individual experts, as well as influential groups such as the Clinical Laboratory Improvement Advisory Committee. “The purpose of this paper is to illustrate the seriousness of laboratory data-related interoperability issues and display discrepancies in EHR systems, and propose focus areas for action by laboratory professionals to support resolving those issues,” the report says.
The three focus areas for action cited by the authors include engagement, data integrity and usability, and innovation. In the area of engagement, the paper suggests that laboratorians provide expertise in the design, development, and implementation of EHRs at both national and local levels. Strategies for doing so include: serving on federal policy and standards advisory committees; monitoring and submitting comments on proposed federal rules and guidelines; and finding opportunities for collaboration with federal agencies, standards development organizations, and other stakeholders. Read the full CDC report online. ​ Adobe PDF file

Routine Vitamin D Testing Not Justified, Panel Says
More and more people are getting tested for vitamin D deficiency, but the value of the tests remains too murky to make them part of routine medical care, an influential advisory group says.
There simply isn't enough evidence that testing the blood of healthy, symptom-free people for vitamin D deficiency will end up improving people's health, says the draft recommendation released by the U.S. Preventive Services Task Force. The task force — an independent panel whose recommendations influence which prevention measures are widely adopted — also says there's little evidence, testing would hurt. It's true that low vitamin D levels have been linked with problems including bone fractures, falls, cancer, diabetes, heart disease, depression and even early death, the task force says. But studies have not shown that giving vitamin D supplements to apparently healthy people with low levels can prevent those problems.
Another issue: Expert groups disagree on how low is too low when it comes to blood levels of vitamin D. Also, different lab tests can produce different results. Because of varying standards and study methods, estimates of vitamin D deficiency in the U.S. population range from 19% to 77%, the task force says. "There's a lot of controversy here," says task force co-chair Albert Siu, a geriatrics professor at the Icahn School of Medicine at Mount Sinai in New York.

FDA Grants Emergency Use to Arbor Vita’s Influenza A Assay
U.S. government and foreign laboratories may now use Arbor Vita’s A/H7N9 Influenza Rapid Test to confirm or rule out infection with the H7N9 strain of influenza A in patients showing signs of respiratory illness. The emergency use authorization, granted April 25 and posted online Monday, requires Arbor Vita to distribute the rapid test fact sheets for healthcare professionals and patients to laboratories and online, ensure that laboratories using the test at home and abroad have an adequate means of reporting test results to healthcare workers and federal and state authorities, track and report adverse events and false positive and negative results and keep records of device usage. The company must also make clear in its labeling and marketing tools that the test is not currently FDA-approved.

AACC Urges NY to Rescind Blood Glucose Meter Policy

On January 7, FDA released draft guidance with suggestions for remedying this issue. In response to this draft guidance, the NYS Department of Health informed NYS laboratory directors that any lab engaging in off-label use of glucose meters must have a NYS clinical laboratory permit in the category of clinical chemistry and that only personnel licensed by the NYS Education Department are eligible to perform off-label testing. Additionally, the new NYS policy requires labs to perform studies showing that their blood glucose meters perform with an acceptable level of precision when used for off-label purposes. Until a lab meets these requirements, it must stop using glucose meters in critical care settings and/or at health fairs and other community events to screen the public for diabetes (which is considered off-label usage). After reviewing the NYS Department of Health’s directive, AACC urges the Department to rescind or temporarily suspend the directive until the federal guidelines regulating off-label use of blood glucose meters are finalized. 

AACC’s Advocacy Network in Action: Capitol Hill Visits, Communiques Aimed at Encouraging the Federal Government to Work with the Private Sector in Harmonizing Clinical Laboratory Test Results.
AACC leaders recently visited Capitol Hill to advocate for “reporting language” that would encourage federal agencies to work with the private sector toward harmonizing clinical laboratory results. Gary Myers, PhD, FACB, vice president of science and practice affairs, joined AACC’s president-elect, David Koch, PhD, director of clinical chemistry at Grady Memorial Hospital in Atlanta, to meet with staff members in the offices of Sen. Saxby Chambliss (R-Ga.), Sen. Johnny Isakson (R-Ga.), and Rep. Rob Woodall (R-Ga.). These visits built on earlier meetings Myers and Vince Stein, PhD, AACC’s director of government affairs, had with staff of House and Senate members in leadership positions with each chamber’s Appropriations Committee and relevant subcommittees.


Laboratory Testing / Diagnostics

Researchers Offer Guidance on Clinical use of Genomic Tests
With around 10,000 tests using genome-based technology expected to be ordered this year, an article published in The New England Journal of Medicine provides guidance on using the technology effectively in clinical practice. "The technologies that were used for the Human Genome Project are now distilled down to practical tools that clinicians can use to diagnose and, hopefully, treat diseases in patients that they couldn't treat before," co-author Leslie G. Biesecker, M.D., chief of the National Human Genome Research Institute's Medical Genomics and Metabolic Genetics Branch, said in an announcement. His co-author on the NEJM article is Robert C. Green, M.D., of Brigham and Women's Hospital and Harvard Medical School in Boston.

With Time, Greater Clarity on HPV Screening

The Food and Drug Administration on April 24 approved use of the Cobas HPV test manufactured by Roche Molecular Systems as a primary standalone screen for cervical cancer in women 25 years and older. There was a lot of chatter in the general interest press about cervical cytology, not all of it well informed. If the professional societies agree to add this new option to future guidelines, they will probably include recommendations for followup on specific results and cotesting via specific combinations of cytology and HPV testing. Although final results of the ATHENA study have not yet been published, FDA approval was based on a controlled trial with ensured followup and likely central review of specimens. We do not know how well the controlled trial will replicate in practice because we have little experience with a cervical cancer screening paradigm of this kind in the United States, where followup is opportunistic. We currently have no comparative studies of HPV-only testing and cotesting with cytology and HPV.

INSIGHT-As Sequencing Moves Into Clinical use, Insurers Balk

Once strictly the domain of research labs, gene-sequencing tests increasingly are being used to help understand the genetic causes of rare disease, putting insurance companies in the position of deciding whether to pay the $5,000 to $17,000 for the tests. As use of the new technology has grown, a number of insurers, including Blue Cross Blue Shield, have reacted by putting the brakes on reimbursement, according to interviews with researchers, diagnostic experts and insurance executives. Insurers are demanding proof that the results will lead to meaningful treatments among the estimated 2 million Americans with a serious, undiagnosed disease, still an unlikely prospect in the majority of cases. Genetics experts say that sequencing more than doubles the chances that families get a diagnosis, and saves spending on multiple tests of single genes. Even if no treatment is found, the tests can also end hugely expensive medical odysseys as parents, frantically search for the cause of their child's furtive illness. Until the reimbursement issue is resolved, some smaller diagnostics players will likely stay on the sidelines

New DNA Blood Test Can Better Identify Rejection After a Heart Transplant

A new DNA blood test may reveal whether or not a heart transplant recipient will experience rejection from a donor organ. The developers of the test believe it could potentially eliminate the need for invasive heart biopsies in the future – procedures that transplant recipients must undergo regularly to monitor organ rejection. In a new study published in the journal Science Translational Medicine, researchers from Stanford University detailed their new test, which focuses on detecting cell-free DNA – pieces of DNA that circulate freely in the bloodstream. During a transplant procedure, some of the donor’s heart cells are attacked and killed by the recipient’s immune system, causing them to release their genetic material into the blood.  If the organ is rejected, a larger portion of heart cells are attacked, releasing a higher percentage of cell-free DNA in the bloodstream.

New Test Detects Toxic Prions in Blood

The first cases of Mad Cow disease in humans (properly called variant Creutzfeld Jakob Disease, or vCJD) occurred in the late 1990s and are thought to be the consequence of eating contaminated beef products. Since then, several cases of secondary infections caused by transfusions with blood from donors who subsequently developed vCJD have been reported, raising concerns about the safety of blood and blood products. A paper published in PLOS Pathogens now describes an assay that can detect prions in blood samples from humans with vCJD and in animals at early stages of the (asymptomatic) incubation phase. To develop the assay, Olivier Andréoletti, from the Ecole Nationale Vétérinaire de Toulouse, France, and colleagues first optimized a method called PMCA (for Protein Misfolding Cyclic Amplification). The method mimics in a test tube the process by which misfolded (toxic) prions propagate, and the researchers determined experimental conditions that enable efficient PMCA amplification of the vCJD agent in the blood.

Can You Trust Lyme Disease Tests?

As Lyme disease becomes an increasingly challenging public health threat across the Northeast, a growing number of tests for the vexing ailment may be misdiagnosing patients when telling them that they have – or don't have – the tick-borne illness. “There are desperately ill people looking for an answer. But there are so many companies using (unproven tests) … you can’t trust them,’’ said Andrew Onderdonk, a professor of pathology at Harvard Medical School who was diagnosed with Lyme disease in 2012 using a federally recommended test.

ATCC, CDC, Thermo Fisher Partner to Bring HIV Drug Resistance Assay to Resource-Poor Countries
ATCC has partnered with the US Centers for Disease Control and Prevention and Thermo Fisher Scientific to bring a rapid, cost-effective PCR-based method of monitoring HIV drug resistance to resource-limited countries, ATCC said. Specifically, ATCC and CDC have partnered to scale up and distribute the kit to World Health Organization-designated and CDC-supported genotyping laboratories established through the US President's Emergency Plan for AIDS Relief (PEPFAR).

Bio-Rad Laboratories Launches Fifth Generation HIV Test

Bio-Rad Laboratories has launched its fifth generation human immunodeficiency virus (HIV) test, BioPlex 2200 HIV Ag-Ab kit, for markets outside the US. The BioPlex 2200 HIV Ag-Ab kit, similar to fourth generation assays, offers early detection of HIV by detecting HIV antigens (proteins that are part of the HIV virus) and HIV antibodies (proteins that are produced by the body to fight the HIV infection). In addition to the early detection offered by the fourth generation assays, the fifth generation HIV test provides more information by specifically identifying which individual HIV 1 and HIV 2 marker is positive. This additional information indicates if the patient was recently infected and can help guide follow-up testing.

Qiagen CMV Assay Wins FDA Approval

The new assay is designed to quantify cytomegalovirus viral load in organ transplant patients in about three hours, and is the only FDA-approved PCR-based assay optimized for low- to mid-throughput CMV testing, Qiagen said. CMV testing is primarily used to aid in the management of solid organ transplant patients to assess viral load in response to antiviral drug therapy. These patients are at high risk of life-threatening CMV infections in the months following surgery, and antiviral drug treatment is standard.

Genetics Startup 23andMe Takes Step on Path to FDA Approval

Genetics startup 23andMe said it is one step closer to resuming sales of its full-fledged health product, with the U.S. Food and Drug Administration accepting its first health report for review. The home genetics company said in a blog post that the FDA will begin evaluating the company's submission for a 510(k) application, a regulatory process that applies to most medical devices sold in the United States. Kathy Hibbs, 23andMe's chief legal and regulatory officer, said in the blog post that the submission focused on one single inherited condition, called Bloom Syndrome.

Physicians and Pathologists at Atrius Health Collaborate to Reduce Unnecessary Clinical Laboratory Test Orders and end up Saving $1 Million Annually

In Massachusetts, a 1,000-physician group gets 70% of revenue from capitated payments, motivating the physicians to reduce unnecessary utilization of medical laboratory tests Accumulating market evidence indicates that unnecessary utilization of medical laboratory tests—a problem bemoaned by pathologists for decades—may finally be addressed by an unlikely source: ordering physicians! Such a trend would have both positive and negative consequences for clinical laboratories throughout the United States. What motivates physicians, on their own initiative, to reduce the unnecessary utilization of medical laboratory tests are changes in how they are paid. Many private health plans are reimbursing office-based physicians using global payment arrangements, such as capitation.

Pathologists Urge AMA to Keep Anti-Markup, Lab Billing Sections in Code of Ethics

The College of American Pathologists (CAP) and other groups representing pathologists are opposing proposed changes to the American Medical Association's Code of Ethics that they feel will weaken the code by removing sections on laboratory billing and anti-markup of pathology services. CAP leadership recently spoke during a hearing before the AMA Council on Ethical and Judicial Affairs (CEJA), which launched a major project to review and update the code in 2008. CAP President Gene Herbek, M.D., FCAP, also wrote a letter June 16 outlining the college's concerns regarding the proposed changes.

A Question of Capital: Will Lab Purchasing Take a U-turn?

When CAP TODAY talked with directors of several of the largest laboratory operations in the country about their own purchasing plans, their forecasts were decidedly mixed. Opinions differ as to whether circumstances call for a buying binge, just procurement as usual, or a batten-down-the-hatches response. From Stan Schofield’s perspective, for example, the Medicare/Medicaid reimbursement cuts in store for laboratories due to the Protecting Access to Medicare Act of 2014, signed April 1, are casting a big shadow over the industry. “It will be challenging. We’re moving from difficult to dire,” says Schofield, president of NorDx and senior vice president of MaineHealth in Scarborough, Me.


Research and Development

In Single Gene, a Path to Fight Heart Attacks
Two major studies by leading research groups published independently identified mutations in a single gene that protect against heart attacks by keeping levels of triglycerides — a kind of fat in the blood — very low for a lifetime. The findings are expected to lead to a push to develop drugs that mimic the effect of the mutations, potentially offering the first new class of drugs to combat heart disease in decades, experts say. The researchers discovered that people with a genetic predisposition to higher triglyceride levels had more heart attacks and those with genetically lower triglyceride levels had fewer. Their study, published last year in Nature Genetics, did not isolate individual genes, though. It just pointed to signposts on the long stretch of 30 million DNA letters that were near the genes. So the investigators began a hunt for the genes themselves. One gene, APOC3, stood out. The scientists found four mutations that destroyed the function of this gene. “Those who carry the gene mutations have a 40 percent reduction in triglyceride levels and a 40 percent lower risk of heart disease,” said Dr. Sekar Kathiresan of Massachusetts General Hospital and the Broad Institute.  The other study, led by Dr. Anne Tybjaerg-Hansen of Copenhagen University Hospital, used data from 75,725 subjects to learn whether low triglyceride levels were linked to a reduced heart attack risk. They were. The researchers also asked whether people who had mutations destroying the APOC3 gene had fewer heart attacks. They did. Those with such mutations had a 44 percent reduction in triglycerides and a 36 percent lower heart attack risk. The Danish data, Dr. Kathiresan said, “are eerily consistent with our data.” “It is incredible how reproducible the finding is,” he added. Yet the two groups worked independently, with The New England Journal of Medicine coordinating publication of their studies.

Diabetes Gene 'Raises risk tenfold'

A genetic susceptibility that gives a tenfold increased risk of developing type 2 diabetes has been discovered. The gene mutation, found in the population of Greenland, will give clues to the different causes of the condition, say Danish scientists. The research, published in Nature, adds to evidence genetics plays a role in the chances of developing diabetes. Other factors included lifestyle, with obesity and a bad diet increasing risks, said a diabetes charity. Several susceptibility genes have been linked with diabetes, meaning that if an individual is carrying one of these genes they face a greater risk of developing diabetes.

Mesoblast's MPCs Show Promise in Type 2 Diabetes

Mesoblast (ASX:MSB) mesenchymal precursor cells (MPCs) improved glycaemic control and reduced blood glucose levels in patients with type 2 diabetes during a phase II trial. Results from the single-blind, placebo-controlled, dose escalation study were presented at the 74th American Diabetes Association annual meeting in San Francisco by Dr Jay Skyler. The results show a significant reduction in HbA1c - a measure of blood glucose - levels after eight weeks in the largest dosage MPCs group. They also show a dose-dependent improvement in glycaemic control compared to the placebo group starting at week one. 

To Defeat a Deadly Toxin, Disrupt Its Landing Gear

Botulinum toxin may be the most poisonous substance on the planet. A mere speck of the stuff can kill a person.
But just what makes the toxin so potent?
Part of the answer lies in the molecules that carry the toxin through the body. These carriers, which are produced along with the toxin by the Clostridium botulinum bacterium, protect the toxin as it travels through the hostile environment of the gastroinstetinal tract, and help it bust through the intestinal wall and into the bloodstream. Take away these carriers, and the toxin becomes 30 times less potent. In a paper published in the latest issue of the journal Science, researchers report they have figured out the crystal structure of one of the toxin's molecular carriers. This structure helps scientists understand how the toxin is able to sneak through the lining of the intestine and into the blood.

Scientists Explain Stress-heart Attack Link

Scientists said they may have unravelled how chronic stress leads to heart attack and stroke: triggering overproduction of disease-fighting white blood cells which can be harmful in excess. Surplus cells clump together on the inner walls of arteries, restricting blood flow and encouraging the formation of clots that block circulation or break off and travel to another part of the body. White blood cells "are important to fight infection and healing, but if you have too many of them, or they are in the wrong place, they can be harmful," said study co-author Matthias Nahrendorf of the Harvard Medical School in Boston. Doctors have long known that chronic stress leads to cardiovascular disease, but have not understood the mechanism.

Intense Exercise Appears to Change the Body at a Molecular Level.

Intense exercise changes the body and muscles at a molecular level in ways that milder physical activity doesn’t match, according to an enlightening new study. Though the study was conducted in mice, the findings add to growing scientific evidence that to realize the greatest benefits from workouts, we probably need to push ourselves. For some time, scientists and exercise experts have debated the merits of intensity in exercise. Everyone agrees, of course, that any exercise is more healthful than none. But beyond that baseline, is strenuous exercise somehow better, from a physiological standpoint, than a relative stroll?

Could Stem Cells Help Restore Hearing?
A newly discovered type of stem cell may prove helpful in replacing tissues damaged through hearing loss. Spiral ganglion cells that play a significant role in hearing and the ear's irreversible degeneration in the inner ear could provide self-renewing capabilities, according to a recent study published in BioResearch Open Access. Researchers found that these cells can be grown and induced to differentiate into mature spiral ganglion cells as well as neurons and glial cells that help with hearing.

Herpes Virus Originated in Chimpanzees, Jumping Into Humans 1.6 Million Years Ago

Researchers at the University of California, San Diego School of Medicine have identified the evolutionary origins of human herpes simplex virus (HSV) -1 and -2, reporting that the former infected hominids before their evolutionary split from chimpanzees 6 million years ago while the latter jumped from ancient chimpanzees to ancestors of modern humans - Homo erectus - approximately 1.6 million years ago. The findings are published in the online issue of Molecular Biology and Evolution.

New Attack on Drug-resistant Bugs
Scientists have found a new route to attack antibiotic-resistant bacteria by blocking the mechanism they use to build their exterior coating. The bugs construct this defensive barrier in a complex process that depends on a key dual-protein molecule. Its structure has been mapped using the intense X-rays of the Diamond Light Source in Oxfordshire. Researchers tell the journal Nature that drugs can now be developed to interfere with this LptDE protein.


Public Health and Patient Safety

Health System Report Ranks UK First, US Last
The United Kingdom was ranked highest overall, Switzerland second, and the United States last in a new report that compared the health systems of 11 developed nations. The US, the report noted, spent more than $8500 (£5000; €6270) per capita on health in a year, while the UK spent less than half that, at $3400 per person. The study was the fifth in a series produced by the Commonwealth Fund. It draws on international surveys that the New York City based foundation has conducted with patients and doctors, as well as data on health spending and outcomes from the Organisation for Economic Cooperation and Development and the World Health Organization.
The report ranked the 11 countries in this order:
  • The UK,
  • Switzerland,
  • Sweden,
  • Australia,
  • Germany and the Netherlands (a tie),
  • New Zealand and Norway (another tie),
  • France,
  • Canada, and
  • The US, which was ranked lowest for the fifth time in a row.

Recommendations Address Long-Term Needs of Prostate Cancer Survivors

New American Cancer Society Prostate Cancer Survivorship Care guidelines outline post-treatment clinical follow-up care for the myriad of long-term and late effects an estimated 2.8 million prostate cancer survivors in the United States may face. The guidelines report is published Early Online in the Society's journal, CA: A Cancer Journal for Clinicians. The guidelines are designed to promote optimal health and quality of life for the post-treatment prostate cancer survivor by facilitating the delivery of comprehensive post-treatment care by primary care clinicians. They are based on recommendations set forth by an expert panel convened as part of the work of the National Cancer Survivorship Resource Center, collaboration between the American Cancer Society and The George Washington University Cancer Institute, funded by a 5-year cooperative agreement from the Centers for Disease Control and Prevention (CDC).

Ebola Epidemic ‘Out of control’ in West Africa: Report

An Ebola epidemic is now being characterized as “out of control” by Doctors Without Borders, who have identified more than 60 outbreak hotspots in West Africa, Agence France-Presse reports. “The scale of the current Ebola epidemic is unprecedented in terms of geographical distribution, people infected and deaths,” Doctors Without Borders said in a statement Monday, according to AFP. “The epidemic is now out of control,” said Dr. Bart Janssens, Doctors Without Borders director of operations. “With the appearance of new sites in Guinea, Sierra Leone and Liberia, there is a real risk of it spreading to other areas.”

FDA Approves First U.S. Facility to Produce Seasonal Flu Vaccine With Cell-Based Technology

The U.S. Food and Drug Administration approved the first facility in the United States to manufacture seasonal influenza vaccine using cell-based technology, according to the HHS.  That facility is located in Holly Springs, N.C., and is owned by Novartis of Basel, Switzerland. It can now manufacture cell-based vaccine against seasonal as well as pandemic influenza viruses. With the approval of manufacturing in the Holly Springs facility, the capacity for seasonal influenza vaccine production in the United States can increase by at least 50 million doses.

Joint Commission Issues Alert on Unsafe Injection Practices

The Joint Commission wants healthcare organizations to pay more attention to risks associated with improper use of injectable medicines, and to do something about the problem. "Patients visiting a clinic for an injection to relieve their pain or for chemotherapy don't expect to leave with a new condition such as hepatitis, but unfortunately thousands of patients have been adversely affected in this way when they received an injection at their doctor's office or in the hospital," the commission notes in a statement. In a Sentinel Event Alert issued June 16, entitled "Preventing Infection from the Misuse of Vials," the commission describes factors that contribute to the misuse of vials and offers strategies to curb the problem.

New Strategies to Combat MRSA in Hospitals

New guidelines aim to reduce the prevalence of methicillin-resistant Staphylococcus aureus (MRSA), improve patient safety and prioritize current prevention efforts underway in hospitals. "Many hospitals have made inroads in preventing healthcare-associated MRSA through essential prevention strategies, but some hospitals need additional intervention," said David Calfee, MD, MS, co-lead author of the guidelines with Cassandra Salgado, MD, MS. "This guidance provides a roadmap for prioritizing and implementing strategies." 
Key highlights from the guidelines include: 
•           Conduct an MRSA risk assessment 
•           Implement an MRSA monitoring program and track rates
•           Ensure compliance on hand hygiene recommendations
•           Ensure compliance with contact precautions for MRSA-colonized and infected patients
•           Ensure proper cleaning and disinfection of equipment and environment: 
•           Educate healthcare personnel, patients and families about MRSA
•           Implement an alert system:

US MERS Cases Have Not Infected Any Healthcare Workers

Two public health agencies announced good news about the deadly Middle East Respiratory Syndrome coronavirus (MERS-CoV). The Centers for Disease Control and Prevention (CDC) said it has confirmed that 2 men who brought the virus from Saudi Arabia to the United States did not spread it to healthcare workers or household members. Meanwhile, the World Health Organization (WHO) said that although the global outbreak of MERS-CoV remains worrisome, the upsurge in cases that began in April has weakened, and that "there is no evidence of sustained human-to-human transmission." At the same time, WHO is concerned about possible MERS-CoV exposure for the influx of Muslim pilgrims to Saudi Arabia in July during Ramadan and in October for the Hajj.

Shortage of Saline Solution Has Hospitals on Edge

Hospitals across the country are struggling with a shortage of one of their essential medical supplies. Manufacturers are rationing saline solution — essentially pharmaceutical-grade saltwater. The stuff is used all around hospitals to clean wounds, mix medications or treat dehydration. Now drug companies say they won't be able to catch up with demand until next year. But it's difficult to ramp up production, explains Capt. Valerie Jensen, the director of the drug shortage program at the Food and Drug Administration.

California Launches Price Transparency Initiative

The California Department of Insurance tapped the University of California and the San Francisco-based Consumers Union to create a healthcare price transparency and quality database that will likely be ready to launch within a year. The database will rely on existing data streams, such as claims data from the Centers for Medicare & Medicaid Services and from private payers. Officials said that database would provide information to consumers on fairly commonplace procedures that take place at hospitals.


Health IT and Other

Could Big Data Become Big Brother?
Call it Big Data bloodlust: The more health information being generated by a growing contingency of apps, devices, electronic health records, mHealth sensors and wearables, the broader and stronger the desire for that data becomes. And those are just sources of health information. What about data not traditionally considered part of healthcare that could be used either for or against a patient? In numerous other industries, buying habits are already widely tracked by many social media sites and used for advertising. Though some have complained this is an intrusion, nothing much has been done to prevent this type of surveillance, so far.

Many Physicians Deciding Not to Proceed with EHR Adoption in a Development That Could Affect Clinical Laboratories Offering LIS-to-EHR Interfaces to Doctors
One problem for physicians is that many EHR products that earned Meaningful Use Stage 1 certification have not gained Stage 2 certification. Growing numbers of physicians are deciding that continuing in the federal government’s electronic health records (EHRs) incentive program is not a winning proposition. This is not an auspicious development for the nation’s clinical laboratories and anatomic pathology groups. After all, every medical laboratory in the United States is spending time and money to interface their laboratory information systems with physician clients’ EHR systems to enable electronic lab test ordering and reporting. Thus, if substantial numbers of physicians decide to opt out the federal EHR incentive program; this will create a variety of problems for clinical laboratories providing lab-testing services to these physicians.

Global e-Prescribing Market to Reach $887 Million by 2019

The global market for e-prescribing systems is expected to grow from $250.2 million in 2013 to $887.8 million by 2019, according to a report from Transparency Market Research. Government incentive programs are among the factors driving the market, which is expected to have a compound annual growth rate of 23.5 percent over five years, according to an announcement. The report foresees an immense potential for the growth in implementation of electronic health record systems that include e-prescribing.

The Digital Doctor Will See You Now: How big Data is Saving Lives

"According to the data trends, premature babies with more stable heartbeats were more susceptible to infections. These conclusions were most unexpected," big data guru Rick Smolan tells us. Smolan, co-author of the book The Human Face of Big Data, is a big believer in how the identification of trends within the capacious amounts of data being generated, collected and properly analysed, is our single biggest ally in the battle to extend life.

Mobile Phones Carry Owners' Bacterial 'Fingerprint'Smartphones reflect the personal microbial world of their owners, say US scientists. More than 80% of the common bacteria that make up our personal bacterial "fingerprints" end up on their screens, a study suggests. Personal possessions, such as phones, might be useful for tracking the spread of bacteria, they report in Peer J. They reflect our microbiome - the trillions of different micro-organisms that live in and on our bodies. Mobile phone users have been found to touch their devices on average 150 times a day.

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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