A Weekly Compilation of Clinical Laboratory and Related Information
from The Division of Laboratory Science and Standards
August 22, 2013
- AHRQ Names Kronick as New Director
- NIH to Fund Consortia Studying Rare Disease Biomarkers
- New Analysis Finds Contradictions and Flaws in CMS Rationale for Cutting Anatomic Pathology Services for Medicare Beneficiaries
- For U.S. Healthcare, Time Is Right for Laboratory Automation
- A Hospital Lab’s Biggest Test: The ‘plug and play’ Building
- UC Davis "Lab on a Chip" Measures Heart Disease Risk
- The Time Is Now for Gene- and Genome-Based Bacterial Diagnostics: “You Say You Want a Revolution”
- EHRs Linked to Patient Loyalty, Survey Says
- Researchers Discover How Vitamin B12 Is Made
- DNA Can Be Gently Inserted Into Living Cells Using New High-Tech Laser Method
- Funding Cuts Hurt Disaster Readiness
- Altarum Institute: Higher Healthcare Prices Unlikely
View Previous Issues - Healthcare News Archive
AHRQ Names Kronick as New Director
Health reform researcher Richard Kronick, PhD, will become the new director of the Agency for Healthcare Research and Quality (AHRQ) after longtime director Carolyn Clancy, MD, leaves the post later this month. The announcement was made public in the agency's daily afternoon electronic newsletter. Kronick joined the Department of Health and Human Services (HHS) in January 2010 as deputy assistant secretary for planning and evaluation and oversaw the Office of Health Policy.
The online report has hypertext links to brief wrap-ups of the 24 projects , such as a quality improvement initiative at an internal medicine faculty practice at Northwestern University. The 31-page report, “Findings and Lessons from the Improving Quality Through Clinician Use of Health IT Grant Initiative ” summarized the results of that IT grant initiative from AHRQ. It recounts the experiences of 24 projects funded by AHRQ from 2007-12. The application of health information technology in primary-care settings can improve the quality of care, but it's no magic wand for quality improvement, according to a report on two dozen grant programs funded by the Agency for Healthcare Research and Quality.
NIH to Fund Consortia Studying Rare Disease Biomarkers
Ten institutes at the National Institutes of Health plan to provide $17.5 million in funding next year to support a network of as many as 14 consortia that will pursue clinical research projects focused on rare diseases. A major aim for these centers will be to investigate potential biomarkers for disease risk and severity and to measure clinical outcomes that could be applicable to clinical trials. Although rare diseases are defined as conditions that afflict less than 200,000 Americans, there are an estimated 7,000 of these disorders and they affect around 25 million people in this country, according to the NIH.
A bipartisan group of U.S. senators and congressmen is urging the Centers for Disease Control to complete a new, comprehensive report on the health effects of toxic tap water at the Camp Lejeune Marine base. The lawmakers also want the agency to investigate whether people were exposed to airborne toxins inside buildings after contaminated wells at the North Carolina base were closed in 1985. And they asked the agency to look into the feasibility of a "cancer incidence study" for Lejeune. The four senators and two representatives were reacting to news that the Agency for Toxic Substances and Disease Registry, or ATSDR, a division of the CDC, intends to issue a less comprehensive report than the one it released in 1997. The original public health assessment was withdrawn four years ago because of incomplete data.
Milestone Study Probes Cancer Origin
Scientists are reporting a significant milestone for cancer research after charting 21 major mutations behind the vast majority of tumours. The disruptive changes to the genetic code, reported in Nature, accounted for 97% of the 30 most common cancers. Finding out what causes the mutations could lead to new treatments. Some, such as smoking are known, but more than half are still a mystery. Cancer Research UK said it was a fascinating and important study. A tumour starts when one of the building blocks of bodies, a cell, goes wrong. Over the course of a lifetime cells pick up an array of mutations which can eventually transform them into deadly tumours which grow uncontrollably.
Cancer origins—The international team of researchers was looking for the causes of those mutations as part of the largest-ever analysis of cancer genomes. The well-known ones such as UV damage and smoking mutate the DNA, increasing the odds of cancer. But each also leaves behind a unique hallmark - a piece of "genetic graffiti" - that shows if smoking or UV radiation has mutated the DNA.
Scripps to Study How Mobile Devices Affect Health Care Costs
Scripps Health, a nonprofit health system in San Diego, has launched a research project called Wired 4 Health through its Scripps Translational Science Institute (STSI) to see how mobile medical devices impact health care costs. "Through this study, we will be able to demonstrate where these technologies are providing the most economic value to the health care system and where there is room for improvement," Chris Van Gorder, CEO of Scripps Health, said in a statement. STSI is enrolling 200 participants among Scripps' 13,500 workers and family members as well as people with chronic conditions such as diabetes, high blood pressure or heart arrhythmias.
EHR Costs Outweigh Financial Benefits, Doctors Say
Physicians believe electronic health records can improve patient outcomes but feel that EHR costs outweigh any financial benefits they might have, according to the fourth annual Athenahealth Physician Sentiment Index. The survey also found that doctors see receiving third-party payments as increasingly complex but are getting less frustrated with the process. Similarly, physicians doubt government involvement can have a positive impact on healthcare, “but the passion surrounding it seems to have lessened,” according to the survey.
EHRs Linked to Patient Loyalty, Survey Says
A new study suggests that there may be a link between a physician’s office use of electronic health records (EHRs) and patients’ loyalty. Close to 24% of patients say they are currently using EHRs, according to the EMR Patient Impact Study, which was conducted by Aeffect Inc and 88 Brand Partners. "There is solid evidence that the investment providers continue to make in EMR systems is likely to put adopters at a competitive advantage and yield dividends beyond the expected operational efficiencies—namely it will enhance patient loyalty and satisfaction.” [says Tamara O'Shaughnessy, vice president of Aeffect Inc.] The study comes out on the heels of a report released by the Centers for Disease Control that stated 72% of physicians have adopted some sort of EHR system.
The vitamin D receptor (VDR) -- not the vitamin itself -- may inhibit a process that turns adipocytes into "brown" or metabolically active fat, researchers found. In a series of experiments with human fat cells, VDR inhibited the expression of a key mediator of energy metabolism -- uncoupling protein-1 (UCP1) -- by binding to an area in the promoter proximal region of the gene, Brian Feldman, MD, PhD, and Peter Malloy, PhD, of Stanford University School of Medicine in Stanford, Calif., reported online in Molecular Endocrinology. Conversely, knocking out the receptor led to expression of UCP1, resulting in a browning of adipocytes, they wrote. "These data support pursuing the therapeutic strategy of developing factors that specifically target releasing the beige fat expression profile of human cells," they wrote.
For U.S. Healthcare, Time Is Right for Laboratory Automation
As the United States begins to address the impact of healthcare reform, global health systems are facing unprecedented challenges, including the economic burdens associated with rising costs, chronic diseases, and caring for aging populations. As a result, there is growing demand for greater quality and efficiency in the delivery of patient-care services. Laboratories worldwide are facing similar challenges, fueled by greater demand for diagnostic testing, shortages of trained technologists, new quality mandates for health providers, and changing reimbursement policies. The key challenge for medical testing laboratories of all sizes and their suppliers is to find innovative and cost-effective ways to improve testing efficiency, eliminate errors, conserve labor, and relieve workload pressures.
A Hospital Lab’s Biggest Test: The ‘plug and play’ Building
The resulting $75 million, three-story lab, which opened in 2012, primes Cleveland Clinic Laboratories to become a leading national reference laboratory — the type that performs many of the specialized tests that regional hospitals aren’t equipped to do on their own. It houses labs with the greatest growth potential, such as microbiology and infectious diseases. With that expansion in mind, the new space was created with extraordinary flexibility so it can grow as business increases and technology changes. No matter what new machines arrive and what power they demand, it will be a cinch to get them up and running; as one executive explained it, it’s “plug and play.”
UC Davis "Lab on a Chip" Measures Heart Disease Risk
New test mimics artery conditions, detects inflammatory cells linked with atherosclerosis and myocardial infarction. Using a special microchip that can perform laboratory functions, a team of cardiologists and biomedical engineers from UC Davis has identified cells linked with inflammation and varying degrees of heart disease. The “lab on a chip,” which is based on technology used to evaluate chemicals and cell-to-cell interactions, may one day lead to a rapid test that doctors could use to better predict, treat and monitor atherosclerosis. The study is published online in the Proceedings of the National Academy of Sciences of the United States of America.
Last week finalists of the Nokia Sensing XCHALLENGE, a competition of companies that are developing software and hardware technologies to improve various aspects of health, were announced. One of them is Elfi-Tech, an Israeli firm that’s been working on a tiny sensor that can detect blood flow in the skin, the pulse and velocity of blood under the skin, coagulation status, and the extent of vascular aging.
Utilizing this information, the platform can detect health perturbations related to Cardiac, Vascular, Respiratory and Neurological pathologies.
New Biochip Holds Great Promise for Quickly Triaging People After Radiation Exposure
Currently, the most common way to measure radiation exposure is a blood assay called dicentric chromosome assay that tracks chromosomal changes after exposure. Another approach is to watch for the onset of physical symptoms. But these methods take several days to provide results, which is far too late to identify people who’d benefit from immediate treatment.
The new, much faster method comes about thanks to a collaboration between scientists from radiation biology, biostatistics, and engineering disciplines. “You add a drop of blood, wait a few minutes, and get results,” says [Andy Wyrobek of Berkeley Lab's Life Sciences Division]. Their proof of principle test matched results obtained via a widely used molecule-detection test called an ELISA assay. It also worked up to seven days after exposure.
The Time Is Now for Gene- and Genome-Based Bacterial Diagnostics: “You Say You Want a Revolution”
Clinical microbiology is poised to move into a dynamic age by embracing molecular diagnostic techniques, such as polymerase chain reaction–based amplification techniques and whole-genome sequencing (WGS). These technologies will revolutionize data acquisition for theranostics and the tracking of outbreaks. Whole-genome sequencing originally proved its worth through investigations of infectious agents.1 In this issue of JAMA Internal Medicine, Reuter et al2 now advocate WGS for routine diagnostics and public health microbiology. These ideas are not as far-fetched as they may initially sound. Although the cost and time to conduct WGS would have once been prohibitive, a bacterial WGS can be performed for less than $100 in 1 day’ s time. Moreover, the computational systems for performing the analytics on the WGS data allow for rapid turnaround times.
Researchers say they have uncovered how bacteria may set off a chain reaction leading to bowel cancer. Fusobacteria, commonly found in the mouth, cause overactive immune responses and turn on cancer growth genes, two US studies reveal. The microbes had been linked with colorectal cancer before but it was not known whether they were directly involved in tumour growth. The early findings are published in the journal Cell Host & Microbe. In addition to potential new treatments, the discovery could lead to better early diagnosis and prevention, experts hope.
Microbiologists Identify What Triggers Disease - From Harmless Colonizers to Virulent Pathogens
The bacteria Streptococcus pneumoniae harmlessly colonizes the mucous linings of throats and noses in most people, only becoming virulent when they leave those comfortable surroundings and enter the middle ears, lungs or bloodstream. Now, in research published recently in mBio, University at Buffalo researchers reveal how that happens. "We were asking, what is the mechanism behind what makes us sick?" explains Anders P. Hakansson, PhD, assistant professor of microbiology and immunology in the UB School of Medicine and Biomedical Sciences. "We are looking to find ways to interfere with the transition to disease. Few have looked at the specific mechanism that suddenly makes these bacteria leave the nose where they typically prefer to reside and travel into the lungs or the middle ear where they cause disease. If we can understand that process, then maybe we can block it."
Researchers Learn How Typhoid Mary's Microbes Ticked
Stanford Univ. School of Medicine scientists have shown how salmonella — a bacterial menace responsible for hundreds of thousands of deaths each year from typhoid fever and food poisoning — manages to hide out in immune cells, altering their metabolism to its own benefit, much as someone might remodel a newly rented home to suit his own comfort. Salmonella’s ability to position itself inside infected people’s cells for the long haul can turn them into chronic, asymptomatic carriers who, unknown to themselves or others, spread the infectious organism far and wide. The findings, published in Cell Host & Microbe, could lead to new and better treatments for typhoid fever.
AARP Announces Health Law Tool for Consumers
AARP announced new resources available to all Americans looking for facts about the Affordable Care Act including a new online tool called Health Law Answers. These resources are a part of AARP's ongoing nationwide effort to educate Americans about the health care law and what it means for individuals - whether they have health coverage or not - by providing simple, clear-language information about the law and resources for families to understand what the law means for them and how to access new available benefits. The new tool - HealthLawAnswers.org - is a quick and easy way to get customized information based on where you live, gender, your family size, income and insurance status.
Lead Increases School Suspension Risk Threefold
Children who are exposed to lead are nearly three times more likely to be suspended from school by the 4th grade than children who are not exposed, according to a new Univ. of Wisconsin-Madison study funded jointly by the Robert Wood Johnson Foundation and the Wisconsin Partnership Program Education and Research Committee. "Students who are suspended from school are at greater risk of dropping out, twice as likely to use tobacco, and more likely to engage in violent behavior later in life," says first author Michael Amato, a doctoral candidate in psychology and the Nelson Institute for Environmental Studies at UW-Madison. "Our study found that children exposed to lead were more than twice as likely to be suspended in the 4th grade, which means that lead may be more responsible for school discipline problems than many people realize."
20 Million Missing Base Pairs of DNA Mapped to Previously Uncharted Regions of the Human Genome
Hidden in the tangled, repetitious folds of DNA structures called centromeres, researchers from Harvard Medical School and the Broad Institute have discovered the hiding place of 20 million base pairs of genetic sequence, finding a home for 10 percent of the DNA that is thought to be missing from the standard reference map of the human genome. Mathematician Giulio Genovese, a computational biologist in genetics at HMS and at the Broad Institute, working in the lab of geneticist Steven McCarroll, HMS assistant professor of genetics and director of genetics for the Stanley Center for Psychiatric Research at the Broad Institute, found a way to use the genomes of Latinos to interpolate the locations of these missing pieces. Their findings were published in The American Journal of Human Genetics. he millions of base pairs of sequence that Genovese and McCarroll's team have located will be added to the next release of the reference human genome assembly - the "Google maps" of the human genome that geneticists use every day - providing a more comprehensive view of the genome and how the pieces all fit together.
Researchers Discover How Vitamin B12 Is Made
A scientific breakthrough by researchers at the University of Kent has revealed how vitamin B12/antipernicious anaemia factor is made - a challenge often referred to as 'the Mount Everest of biosynthetic problems'. Vitamin B12 is pieced together as an elaborate molecular jigsaw involving around 30 individual components. It is unique amongst the vitamins in that it is only made by certain bacteria. In the early 1990's it was realised that there were two pathways to allow its construction - one that requires oxygen and one that occurs in the absence of oxygen. It is this so-called anaerobic pathway, which is the more common pathway, that proved so elusive as the components of the pathway are very unstable and rapidly degrade. However, as explained in a paper published by PNAS (Proceedings of the National Academy of Sciences of the United States of America), bioscientists at the University of Kent have trained a friendly bacterium called Bacillus megaterium to produce all of the components of the anaerobic B12 pathway.
DNA Can Be Gently Inserted Into Living Cells Using New High-Tech Laser Method
A team of scientists in South Korea have now developed the most precise method ever used to insert DNA into cells. The method combines two high-tech laboratory techniques and allows the researchers to precisely poke holes on the surface of a single cell with a high-powered "femtosecond" laser and then gently tug a piece of DNA through it using "optical tweezers," which draw on the electromagnetic field of another laser. The team's approach, which is a breakthrough in precision and control at the single-cell level, was published today in the Optical Society's (OSA) open-access journal Biomedical Optics Express. "What is magical is that all this happens for one cell," said Yong-Gu Lee, an associate professor in the School of Mechatronics at the Gwangju Institute of Science and Technology in South Korea and one of the researchers who carried out the study.
Acceptance of digital pathology systems is growing steadily in both North America and Europe. One sign of this acceptance is the rapid increase in the purchase of digital pathology systems by anatomic pathology laboratories in these regions. In fact, one consulting company says that the digital pathology market is poised to explode over the next seven to eight years. This will happen as medical laboratories acquire and deploy digital pathology systems to improve their connectivity with other providers, to improve productivity of pathologists, and as a tool to reduce costs. Digital Pathology Sales Predicted to Double in Coming Years These predictions were made in a new report from Frost & Sullivan. The analysis estimates that, in the European market for digital pathology, sales will more than double during the next seven years. Frost & Sullivan says that sales will expand from $62.23 million in 2012 to $143.59 million by 2019.
Vitamin D no Help in Isolated Systolic Hypertension
A small, randomized trial of high-dose vitamin D has failed to show a benefit of the supplement in reducing blood pressure or improving vascular health in older patients with isolated systolic hypertension (ISH). Results of the Vitamin D in ISH (VitDISH) trial, led by Dr Miles D Witham (University of Dundee, Scotland) were published online yesterday in JAMA Internal Medicine. Authors of the study, which randomized 159 patients to either 100 000 U cholecalciferol every three months for one year or to placebo, note that vitamin-D supplementation had never been studied in the setting of ISH, despite this being the most common form of hypertension in the elderly. In VitDISH, subjects' mean 25-hydroxyvitamin-D levels were low at baseline and increased significantly over the 12 months. Yet these increases did not translate into meaningful changes in mean office blood pressure, 24-hour blood pressure, arterial stiffness, endothelial function, cholesterol or glucose levels, or walking distance. It's possible that "vitamin D may have no significant effect on blood pressure" at all or in this specific group of patients, the authors muse. Another possibility is that some subjects enrolled in VitDISH merely had white-coat hypertension, diluting the impact of vitamin D.
Funding Cuts Hurt Disaster Readiness
Federal grants for local public health emergency preparedness have dropped more than 40% since 2006, according to Jack Herrmann, chief of public health preparedness at the National Association of County and City Health Officials (NACCHO) here. As a result the 2,800 local health departments nationwide have lost a combined 44,000 jobs since 2008, he said. A quarter of local departments reduced or eliminated preparedness programs because of the funding cuts. Herrmann said one of the services local public health departments are cutting is immunization clinics, where parents can turn for free services when back-to-school shots are inaccessible elsewhere.
"How we get judged as a society during a response is, how do we respond to the needs of the most vulnerable populations in our communities?" Ali Khan, MD, MPH, director of the Office of Public Health Preparedness and Response at the CDC, said Thursday. "We need to get that right."
Altarum Institute: Higher Healthcare Prices Unlikely
Healthcare prices are growing at historically low rates, according to new estimates from the Altarum Institute. And because of a revision to federal benchmark data, researchers estimate that the portion of the economy consumed by healthcare is less than previously thought. The percentage of the gross domestic product has averaged about 17.5% (rather than 18%) since the end of the recession, they now believe. Healthcare prices grew 1.1% from July 2012 to July 2013 and were only slightly higher than the May 2013 growth rate of 1.0%, the lowest rate in the institute's decades-long series.
CMS Mulls How to Unseal Medicare Doctor Pay Data
The Centers for Medicare & Medicaid Services is requesting comments on the potential release of payment information that could include the line-item details reported on claims for patient services, or aggregated data for individual physicians. The deadline for comment submissions is Sept. 5. The Dept. of Health and Human Services created policy in 1980 that states “the public interest in the individually identified payment amounts is not sufficient to compel disclosure in view of the privacy interest of the physicians.” The question as to whether this sentiment has changed will be open for discussion.
Recent court ruling in play—On May 31, a federal judge vacated a 1979 injunction preventing the release of the physician information. Dow Jones & Co., the parent company of The Wall Street Journal, along with the consulting firm Real Time Medical Data filed a 2011 lawsuit that sought greater access to the Medicare data. The WSJ and other media outlets had obtained portions of data, but only under the condition that reporters were prohibited from naming individual physicians in published stories about Medicare spending.
New Analysis Finds Contradictions and Flaws in CMS Rationale for Cutting Anatomic Pathology Services for Medicare Beneficiaries
Today the American Clinical Laboratory Association (ACLA) released a report prepared by The Moran Company, a research firm with expertise in Medicare, that found serious contradictions and flaws in a recent proposal from the Centers for Medicare & Medicaid Services (CMS) to drastically cut Medicare reimbursement for anatomic pathology services.On July 8, CMS issued a rule proposing to cut some anatomic pathology (AP) services by as much as 75% by applying lower rates from the Outpatient Prospective Payment System (OPPS) to the Physician Fee Schedule (PFS) where AP services are currently reimbursed. ACLA opposes these draconian cuts to services that are the standard of care for diagnosing deadly cancers (e.g. breast cancer) and commissioned The Moran Company to assess CMS' rationale.
Key findings in the analysis also include the following: The cost accounting data CMS is exclusively relying on in making these cost comparisons for the 38 anatomic pathology services impacted by the proposal is insufficiently granular to be reliable at the level of individual codes. To view report, please visit the American Clinical Laboratory Association website or click here .
Bio-Reference Laboratories Inc. said it purchased a company in northern California that will allow the Elmwood Park-based clinical laboratory to set up a satellite location on the West Coast and have a base of operations in the nation's most populous state. With the acquisition of most of the assets from Hunter Laboratories in Campbell, Calif., Bio-Reference will be able to reduce overhead and conduct testing closer to its West Coast market instead of testing at its Elmwood Park facility, Bio-Reference Chief Information Officer Richard Faherty said.
Cigna Demands Counseling for Breast Test in Myriad Threat
Cigna Corp. (CI) will become the first U.S. health insurer to require genetic counseling nationwide before it pays for tests for hereditary breast and ovarian cancer, a move that may threaten sales for Myriad Genetics Inc. (MYGN) The policy affects tests for the BRCA1 and BRCA2 genes, the most common cause of hereditary breast cancer, as well as genes for hereditary colon cancer and a heart abnormality called long QT syndrome, David Finley, a national medical officer for the Bloomfield, Connecticut-based insurer, said in an Aug. 16 interview. It takes effect Sept. 16. Cigna expects to roughly break even on the program, Finley said, as any savings from eliminating inappropriate tests will be mostly offset by higher reimbursement for counseling.
U.S. Disease Detection Centre Launched
The US Centre for Disease Control and Prevention (CDC) launched its eighth global disease detection centre in Bangladesh on Tuesday. A two-year ‘extensive’ disease detection course also started off at the government’s disease monitoring arm, the Institute of Epidemiology, Disease Control and Research (IEDCR). With this, the institute would now help as a regional centre “to protect the world by rapidly detecting emerging health threats”. CDC has such centres only in China, Egypt, Guatemala, India, Kenya, South Africa and Thailand.
As the recognition process was in progress, the CDC signed agreement with the IEDCR in March to operate a Field Epidemiology Training Program (FETP) to create 'disease detectives'.
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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