viernes, 11 de julio de 2014



Healthcare News

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


July 10, 2014

  • NIH Creates Network to Tackle Mysterious Diseases
  • AMA Adopts Policy to Define Team-Based Medical Healthcare
  • Correcting Laboratory Report Errors
  • Alzheimer's Research in 'Major step' Towards Blood Test
  • Cholesterol Levels May Be Linked to Breast Cancer Risk
  • Scientists Use Stem Cells to Regenerate Human Corneas
  • FDA Aims to Develop E-cigarette Standards, Nicotine Policy
  • Britain Launching Global Superbug Fight
  • CHIME: Meaningful Use Flexibility Rule Provides 'Much needed relief'
  • FDA Decision Frees Health IT Developers


View Previous Issues - Healthcare News Archive


Leading News

NIH Creates Network to Tackle Mysterious Diseases
The government is expanding its "mystery disease" program, funding a network at six universities around the country to help diagnose patients with diseases so rare they've been told they're undiagnosable. The National Institutes of Health has evaluated hundreds of these cold-case patients in its campus research hospital as part of a pilot program since 2008. Demand is so great, there's a waiting list. The agency announced the NIH Undiagnosed Diseases Network, a four-year, $43 million initiative to bring more doctor-detectives on board in the quest to at least put a name to more patients' puzzling symptoms, and eventually find treatments. The centers include: Baylor College of Medicine in Houston, Duke University, Stanford University, University of California, Los Angeles, Vanderbilt University and the Harvard University teaching hospitals Brigham and Women's, Massachusetts General and Boston Children's. The network "will focus on the rarest of disorders, often those affecting fewer than 50 people in the entire world," said Dr. Eric Green, director of NIH's National Human Genome Research Institute.

AMA Adopts Policy to Define Team-Based Medical Healthcare 
The American Medical Association (AMA) voted at its Annual Meeting to adopt policy to define physician-led team-based healthcare as "the consistent use by a physician of the leadership knowledge, skills and expertise necessary to identify, engage and elicit from each team member the unique set of training, experience and qualifications needed to help patients achieve their goals, and to supervise the application of these skills." The definition and list of elements to consider when developing team-based care models were part of a report developed by the AMA's Council on Medical Services aligns with the AMA's Enhancing Sustainability and Satisfaction strategic focus area, which supports the adoption of innovative care models to improve the quality of care and reduce health care costs

Begin Preparing for Pennsylvania’s Enforcement of Act 122
The Pennsylvania Department of Health (“DOH”) Bureau of Laboratories (“Bureau”) recentlyannounced Adobe PDF fileExternal Web Site Icon that it will begin to phase-in enforcement of Act 122External Web Site Icon, which amended the Pennsylvania Clinical Laboratory Act (“Lab Act”), even though Act 122 became effective on December 18, 2013. 
Key Provisions of Act 122:
  • The scope of the Lab Act was expanded so that both in-state and out-of-state laboratories must have a Pennsylvania clinical laboratory permit.
  • Laboratories may not lease or rent space, shelves, or equipment within a health care provider’s office for any purpose. This includes leasing or renting space for the purpose of establishing a specimen collection station.
  • Laboratories may not place any personnel in health care providers’ offices for any purpose, regardless of whether fair market value is offered or given. Laboratories must remove specimen collectors or personnel who process or package specimens from providers’ offices before September 15, 2014.
Exceptions under Act 122:
  • Providers who own and operate their own clinical laboratory may place their employees in the laboratory.
  • Licensed clinical laboratories can refer specimens to another licensed clinical laboratory or to a CLIA-accredited or certified laboratory.
  • Clinical laboratories may own or invest in a building in which space is leased or rented for adequate and fair consideration to health care providers.


Laboratory Testing / Diagnostics

Correcting Laboratory Report Errors
When a laboratory report must be corrected, and the amended results are sent to the ordering physician, questions may be raised regarding the quality of the laboratory work; the proper operation of the instrumentation involved; the competency of the testing staff, and whether the laboratory director or technical consultant/supervisor were fulfilling their oversight responsibilities. While the report is the end result of the testing process, the reasons for the release of an erroneous report must be investigated, and the investigation may need to go all the way back to the pre-analytical phase, from test ordering to specimen collection and handling, through the analytical phase (instruments/reagents/staff competency), to the post-analytic phase that includes verification of the LIS (lab information system) for automated and manual results transfer.

Alzheimer's Research in 'Major step' Towards Blood Test
British scientists have made a "major step forward" in developing a blood test to predict the onset of Alzheimer's disease. Research in more than 1,000 people has identified a set of proteins in the blood which can predict the start of the dementia with 87% accuracy. The findings, published in the journal Alzheimer's & Dementia, will be used to improve trials for new dementia drugs. Experts warned that the test was not yet ready for doctors' surgeries.

Six New Chagas Tests Can Quickly Confirm Disease
Six different rapid diagnostic tests have proved reliable in detecting Chagas disease without having to wait for laboratory confirmation, according to a study by the medical charity Doctors Without Borders and the World Health Organization. Such quick tests could be a breakthrough for controlling the disease, which infects up to eight million people in Latin America and has spread, through migration, to the United States, Europe, Asia and the Western Pacific. Chagas is caused by a parasite normally passed on by the bite of the kissing bug, also known as the reduviid bug or the triatomine bug. It has also been transmitted by blood and organ donations, to fetuses by mothers and, in rare cases, through food with crushed bugs in it.
Chemical Sensor on a Chip
Using miniaturized laser technology, a tiny sensor has been built at the Vienna University of Technology which can test the chemical composition of liquids.  They are invisible, but perfectly suited for analysing liquids and gases; infrared laser beams are absorbed differently by different molecules. This effect can for instance be used to measure the oxygen concentration in blood. At the Vienna University of Technology, this technique has now been miniaturized and implemented in the prototype for a new kind of sensor. Specially designed quantum cascade lasers and light detectors are created by the same production process. The gap between laser and detector is only 50 micrometres. It is bridged by a plasmonic waveguide made of gold and silicon nitride. This new approach allows for the simple and cheap production of tiny sensors for many different applications.

Genetic Test Could 'Hugely Improve' Prognosis for Esophageal Cancer 
Researchers have pinpointed the genetic basis of why some people with a serious complication of acid reflux known as Barrett's esophagus go on to develop esophageal cancer. They believe their discovery, along with a novel non-invasive test, means esophageal cancer could be detected much earlier, thereby improving the prognosis of what is currently a cancer with a poor survival rate. Writing in the journal Nature Genetics, the large international team, including scientists from the University of Southampton in the UK, describe how they found mutations in two genes mark the progression from Barrett's esophagus to esophageal cancer. They also describe how a new non-invasive tool that uses a "sponge-on-a-string" is capable of retrieving cells from the esophagus that can then be tested for mutations in the two genes.

Study Finds That Self-sampling Can Be an Effective HPV Screening Strategy in Developing Countries
Health screens for cancer-causing infections such as HPV can be challenging in developing countries, where people from rural areas can have limited access to health services. New research from the University of Alabama at Birmingham examines the prevalence of high-risk HPV in Nepal, a country with one of the highest cervical cancer rates in South Asia, and finds that self-screening for HPV can be effective. The study, published in PLOS ONE, investigated HPV prevalence and screening methods in the remote district of Accham in far western Nepal.
Source: Web Site Icon


Research and Development

Cholesterol Levels May Be Linked to Breast Cancer Risk
High cholesterol levels may increase a woman's risk of developing breast cancer, a large new British study reports. The findings suggest that keeping tight control over cholesterol through medication could help prevent breast cancer, said lead author Rahul Potluri, a researcher at the Aston University School of Medical Sciences in Birmingham, England. "This is a preliminary study and further research is required before anything can be confirmed," Potluri said. "However, 10 to 15 years down the line, if further prospective studies confirm these findings, there is the possibility for a clinical trial of the use of statins in breast cancer." Statins are prescription drugs used to treat high cholesterol.

Scientists Use Stem Cells to Regenerate Human Corneas
Scientists have developed a new technique to regrow human corneas. Using key tracer molecules, researchers have been able to hunt down elusive cells in the eye capable of regeneration and repair. They transplanted these regenerative stem cells into mice - creating fully functioning corneas. Writing in the journal Nature, they say this method may one day help restore the sight of victims of burns and chemical injuries. Limbal stem cells (LSC) are crucial for healthy eyesight - these cells work to maintain, repair and completely renew our corneas every few weeks. Without them the cornea - the transparent outermost layer of the eye - would become cloudy and our vision disrupted.

Age Has Bigger Impact Than Sex on MicroRNA Profiling of Peripheral Blood 
Researchers using microarray technology to analyze microRNAs in blood samples found age is more of a confounding variable than sex. In 109 physiologically unaffected people, the researchers found 318 miRNAs that were "significantly correlated with age in stage 1 and, after adjustment for multiple testing of 35 miRNAs, remained statistically significant." For sex, 144 miRNAs showed significant dysregulation although none remained significant following adjustment for multiple testing. Clinical ChemistryExternal Web Site Icon (6/2014)

Gene Linked to Higher Stroke and Heart Attack Risk
Researchers have identified a gene that may put people at greater risk of strokes and heart attacks. Writing in PLOS ONE they say the gene fault may encourage the formation of blood clots - the ultimate cause of most heart attacks and strokes. Scientists hope gene tests may help doctors one day to pinpoint individuals more likely to suffer these conditions. But experts say lifestyle factors such as smoking and exercise have the greatest influence on risk. Around one in 10 people in the Caucasian population carries this variation of the gene, named PIA2.

Researchers Find Genetic Link to Autism Known as CHD8 Mutation
In a collaboration involving 13 institutions around the world, researchers have broken new ground in understanding what causes autism. The results were recently published in Cell magazine. "We finally have a clear-cut case of an autism-specific gene," says Raphael Bernier, PhD, lead study author. Bernier says people with a mutation in the CHD8 gene have a very "strong likelihood" that they will have autism marked by gastrointestinal disorders, a larger head, and wide set eyes. In their study of 6,176 children with autism spectrum disorder, researchers found 15 had a CHD8 mutation, and all these cases had similar characteristics in appearance and issues with sleep disturbance and gastrointestinal problems.

Low Doses of Arsenic Cause Cancer in Male Mice
Mice exposed to low doses of arsenic in drinking water, similar to what some people might consume, developed lung cancer, researchers at the National Institutes of Health have found. Arsenic levels in public drinking water cannot exceed 10 parts per billion (ppb), which is the standard set by the U.S. Environmental Protection Agency. However, there are no established standards for private wells, from which millions of people get their drinking water. In this study, the concentrations given to the mice in their drinking water were 50 parts per billion (ppb), 500 ppb, and 5,000 ppb. 50 ppb is the lowest concentration that has been tested in an animal study, and researchers say that because of differing rates of metabolism, mice need to be exposed to greater concentrations of arsenic in drinking water than humans to achieve the same biological dose and similar health effects.

Brain Tumor Invasion Along Blood Vessels may Lead to New Cancer Treatments
Invading glioblastoma cells may hijack cerebral blood vessels during early stages of disease progression and damage the brain’s protective barrier, a study in mice indicates. This finding could ultimately lead to new ways to bring about the death of the tumor, as therapies may be able to reach these deadly cells at an earlier time point than was previously thought possible. This research, published in Nature Communications, was supported by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health.

Scientists Identify 500 New Species of Gut Bacteria
A team of Chinese and Danish researchers has identified 500 new species of gut-residing microorganisms and 800 new bacterial viruses which could attack them. The findings could lead to promising new treatments and possibly circumvent the current crisis of antimicrobial resistance. Using a technique they developed for analyzing DNA sequence data, researchers managed to more than double the number of intestinal bacteria species that has previously been identified. "Using our method, researchers are now able to identify and collect genomes from previously unknown microorganisms in even highly complex microbial societies," says Professor Søren Brunak who has co-headed the study together with Associate Professor Henrik Bjørn Nielsen. "This provides us with an overview we have not enjoyed previously." Coupled with newfound understanding of how the bacteria and viruses interact, the findings are likely to offer more information and possibly lead to new treatments of diseases such as type 2 diabetes, obesity and even asthma.

Human Gene Set Downsized
Based on an analysis of seven proteomic studies, researchers from the Spanish National Cancer Research Center say in a Human Molecular Genetics study that the human genome contains fewer than 20,000 protein-coding genes. "The coding part of the genome is constantly moving," Alfonso Valencia, the vice director of basic research at CNIO, says in a statement. "No one could have imagined a few years ago that such a small number of genes could make something so complex."

Maternal Inflammatory Marker Linked to Children’s Schizophrenia Risk
The children of women who have elevated levels of the inflammatory marker C-reactive protein (CRP) during pregnancy have an increased risk of developing schizophrenia, research suggests. For the study, researchers measured CRP in archived maternal serum samples from the mothers of 777 schizophrenia or schizoaffective disorder patients and 777 matched controls in the Finnish Prenatal Study of Schizophrenia cohort. The serum samples were drawn during the first and second trimesters, giving an indication of prenatal conditions, rather than conditions at the time of delivery.

Just Give It to Me in a Chip
Did you take your meds today? At the right time? All of them?
Following your doctor’s orders can be cumbersome, especially if you’re supposed to take more than one pill a day. That’s why scientists are working to develop microchips that can be preloaded with medications and implanted in our bodies, programmed to administer drugs at a given time, interval and/or dose. A doctor would theoretically be able to adjust the dose, or stop the drug altogether, by remote control. Massachusetts Institute of Technology researchers Robert Langer and Michael Cima started working on this idea with John Santini in the 1990s. Langer and Cima are on the board of directors of MicroCHIPS, a company trying to make the idea a reality.
Source: Web Site Icon


Public Health and Patient Safety

FDA Aims to Develop E-cigarette Standards, Nicotine Policy
The U.S. Food and Drug Administration is working to develop strong product standards for electronic cigarettes and other nicotine delivery devices that will protect public health and enable the agency to withstand legal challenges, its tobacco chief said. Mitchell Zeller, director of the FDA's Center for Tobacco Products, said the agency is exploring potential product standards in the areas of addiction, toxicity and product appeal as it prepares to gain regulatory authority over electronic cigarettes and other nicotine-delivery devices.

Britain Launching Global Superbug Fight
Britain is to lead a global effort to combat antibiotic-resistant superbugs that threaten to knock medicine "back into the dark ages," Prime Minister David Cameron said. Unless new antibiotics are found, the rise of untreatable bacteria threatens a "unthinkable scenario" where once-treatable minor infections become fatal, he said. As bacteria and viruses develop resistance to existing antibiotics, the effectiveness of such treatments naturally diminishes. "That simply cannot be allowed to happen and I want to see a stronger, more coherent global response." Jim O'Neill, the former chief economist of US investment bank Goldman Sachs, is to lead an interational expert group aiming to spark the development of a new generation of antibiotics.

One Tick Bite Can Equal Two Infections
If you're planning to spend quality time outdoors this summer, new research may give you another reason to guard against ticks. In a New York state study, about one in 10 deer ticks were found to be harboring at least two harmful germs, and the tiny bloodsuckers could pass both infections to a human host through a single bite. "A third of ticks around here are infected with the Lyme bacteria, and about a third of those are infected with something else, too," said Felicia Keesing, a biology professor at Bard College in Annandale-on-Hudson, N.Y.

SHEA, APIC & Others Develop New Guidelines to Combat MRSA in Hospitals
The guidelines include information on:
  1. Conducting an MRSA risk assessment
  2. Implementing an MRSA monitoring program and tracking rates
  3. Ensuring compliance on hand hygiene recommendations
  4. Ensuring compliance with contact precautions for MRSA-colonized and infected patients.
  5. Ensuring proper cleaning and disinfection of equipment and environment
  6. Educating healthcare personnel, patients and families about MRSA
  7. Implementing an alert system
Source: Web Site Icon


Health IT and Other

CHIME: Meaningful Use Flexibility Rule Provides 'Much needed relief'
Another major stakeholder has weighed in early on the federal government's proposed rule providing flexibility in the criteria to be used when attesting to Meaningful Use in 2014, with the College of Healthcare Information Management Executives (CHIME) supporting the "new pathways" in the rule. However, CHIME recommends that several changes be made, including:
  • Allowing providers to use a combination of 2011 and 2014 edition of [certified EHR technology] CEHRT when reporting clinical quality measures
  • Retrospectively allowing providers who attest before the rule is finalized to be treated the same by program auditors as those who attest afterward
  • Allowing providers to choose any quarter for reporting through the next calendar or fiscal year to qualify for Meaningful Use in 2015
  • Removing the requirement that providers attest that they have fully implemented 2014 CEHRT, since that may not be possible in 2014 through no fault of the provider

FDA Decision Frees Health IT Developers
In the tightly regulated world of healthcare delivery, those who toil in the fields of information technology had been facing a quandary. Is health IT medicine? If so, it would be subject to government regulation. If it is technology, however, it would be exempt from the rigors of oversight. The Food and Drug Administration resolved the question with the April publication of a framework declaring that the products of health IT are not the same as medical devices and thus not subject to healthcare regulations. Now companies are sorting through what the decision means for their products and systems. 

CMS Proposes Expanded Telehealth Coverage for 2015
Annual wellness visits and psychotherapy are among four services the Centers for Medicare & Medicaid Services is proposing to add to the list of services that can be provided to Medicare beneficiaries via telehealth, according to a proposed update to the Medicare Physician Fee Schedule for the 2015 calendar year. Under the proposal, annual wellness visits and psychotherapy, as well as psychoanalysis and "prolonged evaluation and management services," would be covered as Category 1 services. Such services, according to CMS, are defined as "similar to professional consultations, office visits and office psychiatry services" currently covered by the agency. Wellness visits, CMS says, would include a personalized prevention plan of service, an initial visit and a subsequent visit.

AMA Adopts Telemedicine Policy to Improve Access to Care for Patients
The American Medical Association (AMA) believes that the appropriate use of telemedicine to deliver care to patients could greatly improve access and quality of care, while maintaining patient safety. During its Annual Meeting the AMA voted to approve a list of guiding principles for ensuring the appropriate coverage of and payment for telemedicine services. The principles aim to help foster innovation in the use of telemedicine, protect the patient-physician relationship and promote improved care coordination and communication with medical homes.
The guiding principles stem from a policy report developed by the AMA's Council on Medical Service addressing coverage and payment for telemedicine, which provided robust background on the delivery of telemedicine.
Source: Web Site Icon

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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