A Weekly Compilation of Clinical Laboratory and Related Information
from The Division of Laboratory Science and Standards
September 19 2013
View Previous Issues - Healthcare News Archive
letter , signed by Reps. Louise Slaughter, Rosa DeLauro, and Debbie Wasserman Schultz, and six other leading Democrats, asserts that it is “essential that FDA move this guidance forward to ensure oversight of safe and effective diagnostics.” The House members particularly expressed concerns about molecular diagnostics stating that “widespread development and use of a new generation of advanced molecular diagnostics by clinical laboratories without FDA oversight has exposed a significant gap in the regulatory system.”
- Generate a census of brain cell types
- Create structural maps of the brain
- Develop new, large-scale neural network recording capabilities
- Develop a suite of tools for neural circuit manipulation
- Link neuronal activity to behavior
- Integrate theory, modeling, statistics and computation with neuroscience experiments
- Delineate mechanisms underlying human brain imaging technologies
- Create mechanisms to enable collection of human data for scientific research
- Disseminate knowledge and training
HIPAA Gun Amendment: Privacy at Stake?Provider-patient trust could be put to the test if a proposed amendment to HIPAA by the U.S. Department of Health & Human Services Office for Civil Rights goes into effect. The amendment--sent to the Office of Management and Budget, according to Health Data Management--looks to soften privacy regulations that currently prevent states from reporting patient information to the National Instant Criminal Background System (NICS).
In January, physicians received clarity about their right to ask patients about gun ownership when President Obama signed an executive order promising further guidance explaining that the Affordable Care Act does not prohibit or regulate communication about firearms between clinicians and patients. "Doctors and other healthcare providers ... need to be able to ask about firearms in their patients' homes and safe storage of those firearms," the administration said in a statement, "especially if their patients show signs of certain mental illnesses or if they have a young child or mentally ill family members at home."
Ernst Addresses CLIAC Meeting in AtlantaThe Center for Phlebotomy Education’s Executive Director, Dennis J. Ernst MT(ASCP) addressed members of the Clinical Laboratory Improvement Advisory Committee (CLIAC) last month about the value of well-trained phlebotomists. The biannual meeting was held August 22–23 at the Centers for Disease Control and Prevention’s Communication Center in Atlanta. Ernst’s objective was to heighten awareness among committee members of the important contribution phlebotomists make to the accuracy of laboratory test results, and to stress the importance minimum training requirements would have on test results. “CLIA charges managers with assuring the quality of the samples they test,” said Ernst, “but how do you do that without personnel requirements for those who draw the samples? Or minimum training? How do you define ‘quality? Ernst cited studies showing 95 percent of diagnostic delays are caused by preanalytical errors, 26 percent of preanalytical errors have a significant effect on patient outcomes, and that preanalytical errors constitute up to 93% of all errors committed in the laboratory’s path of workflow.
“Only three states currently require blood collection personnel to be certified or licensed,” said Ernst, referring to California, Louisiana and Nevada. “Only in California are there minimum training requirements. In every other state, styling someone’s hair requires a license, but for something as important and potentially catastrophic as drawing blood, no training requirements or credentials are necessary other than what the employer feels is essential.”
Individualized Quality Control Plan (IQCP): A New Quality Control (QC) Option IntroductionMemorandum Summary
• IQCP: The Centers for Medicare & Medicaid Services (CMS) is implementing a new quality control option for laboratories based on risk management.
• Interpretive Guidelines: The IQCP Interpretive Guidelines, included with this Memorandum, contain procedures for laboratories and guidance for Regional Office (RO) and State agency (SA) surveyors.
• Education and Transition Period: The IQCP Education and Transition Period will begin on 01/01/2014, and conclude on 01/01/2016.
• Training and Education: CMS will provide IQCP training for RO and SA surveyors, and IQCP educational materials for laboratories.
Gene Test May Help Predict Prostate Cancer AggressivenessFinding might one day improve rates of overtreatment, undertreatment in men, study says
A new gene test may help identify slow-growing prostate cancers that will require treatment, a new study suggests. The test revealed the levels of "expression" of three aging-related genes and could be used to predict whether seemingly slow-growing prostate cancer will remain slow-growing, according to Columbia University Medical Center researchers. Using the three-gene test along with existing cancer-staging tests could help doctors better determine which men with early prostate cancer can be safely monitored and spared the potential risks of prostate removal or other invasive treatments, the study authors suggested.
Child Cataract Blood Test DevelopedA blood test that may improve treatment for children born with congenital cataracts has been developed by researchers in Manchester. It analyses every known mutation in the DNA which can cause the condition. The team, which is presenting the test at the British Society for Genetic Medicine, hope it will spread up diagnosis and help decide the best treatment. The charity RNIB described the test as a "welcome step forward". About 200 children are born with cataracts in the UK each year.
A Simple, Fast Correction Method of Triglyceride Interference in Blood Hemoglobin Automated MeasurementHigh blood TG level can cause blood turbidity and erroneously high HGB results by hematology analyzers commonly used in clinical laboratories. Adding a simple step of low-speed centrifugation and measurement of HGB in the plasma fraction allows a quick correction of HGB measurement in lipemic blood samples.
BRAF Mutation Not Prognostic in Thyroid CaA common mutation associated with thyroid cancer did not predict an unfavorable prognosis and had no consistent association with adverse characteristics, a review of patient records showed. The BRAF V600E mutation had significant associations with positive tumor margins and lymph node involvement in a univariate analysis but did not remain significant by multivariate analysis. The mutation was associated with male sex, total thyroidectomy, and adverse follicular variant papillary thyroid cancer (PTC) but not with any other clinicopathologic features, Lisa A. Orloff, MD, of the University of California San Francisco, and co-authors reported online in JAMA Otolaryngology-Head and Neck Surgery.
Fast Tests for Drug Resistance Bolster Malaria FightMalaria researchers have developed what they consider a crucial advance: Simple and fast tests that can tell when parasites have become resistant to the front-line drug against malaria. Taken together, these tests give humans a new tool to counter the malaria parasite's ability to outwit every drug that's ever been devised against it.
FDA Clears Two Quidel Respiratory Infection Assays on Life Tech PlatformThe US Food and Drug Administration has granted 510(k) clearance to Quidel's Molecular Influenza A+B and RSV+hMPV assays for use on Life Technologies' QuantStudio Dx Real-Time PCR instrument, the companies said. The Quidel Molecular Influenza A+B assay detects influenza A and/or B virus, but does not differentiate influenza A subtypes. However, the assay is able to detect subtype H7N9, which has caused more than one hundred infections to date in China, with a mortality rate of approximately 30 percent. FDA also cleared the assay for the detection of H3N2v, a variant influenza virus that has caused infection in patients exposed to infected swine at agricultural fairs in the United States.
Bruker, SAT Ink Deal to Continue Collaboration on SISCAPA-MALDI Protein AssaysBruker said at the 12th annual meeting of the Human Proteome Organization in Yokohama, Japan, that it has launched a second-phase collaboration agreement with SISCAPA Assays Technologies to apply the SISCAPA immunoenrichment mass spec method to its MALDI-TOF instruments. Through the collaboration, the two firms aim to establish fully automated SISCAPA-MALDI workflows in Bruker's demonstration facilities as well as to develop and validate new protein assays, with a particular focus on assays of relevance to clinical microbiology research.
Big LDL Drops With PCSK9 Inhibition in Grouped Phase-2 StudiesAn analysis of four phase-2 studies testing the effectiveness of AMG145 (Amgen), a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), showed the drug reduces LDL cholesterol by 43% to 64%, depending on the dose used. The analysis combines data from studies testing AMG145 as part of different regimens, including as monotherapy and combining it with statin therapy, and different patient groups, including those with heterozygous familial hypercholesterolemia (FH) and statin-intolerant patients. Presenting the results at the European Society of Cardiology (ESC) 2013 Congress, Dr Frederick Raal (University of Witwatersrand, Johannesburg, South Africa) said that although lowering LDL cholesterol is the cornerstone of CVD prevention, "existing therapies to lower LDL cholesterol might not be well tolerated, and not all treated patients achieve LDL-cholesterol goals at tolerated goals."
Marker Predicts Good Results With Stem CellsPediatric stem-cell recipients had significantly better survival and a reduced risk of disease progression when matched with donors who had a specific natural killer (NK)-cell protein, investigators reported. The results add to laboratory evidence that NK cells expressing KIR2DL1 had increased activity against cancer cells, reported Wing Leung, MD, PhD, of St. Jude Children's Research Hospital in Memphis, Tenn., and colleagues online in the Journal of Clinical Oncology. "This approach should dramatically improve the outcome of patients undergoing bone marrow transplantation, regardless of their age or underlying condition," Leung said in a statement.
Partners HealthCare Launches Clinical WGS Test; Clinical Exome to Follow Later this YearAfter two years of development, Partners HealthCare launched a clinical whole-genome sequencing test for rare genetic disorders this summer and plans to offer a lower-priced clinical exome test by the end of the year. The genome sequencing test, which has been in the making since 2011, is available through the Partners Laboratory for Molecular Medicine and can be ordered by doctors across the US. The LMM recommends it for patients with a suspected genetic disease where existing genetic tests have either failed to come up with an answer, or are unlikely to do so. The test costs $9,000 for a single genome, or $18,000 for a parent-child trio, an option that is recommended if a de novo mutation is suspected as the disease cause. In addition, the LMM provides an interpretation-only service of genome or exome sequencing data from other CLIA laboratories for $5,000 for one or more family members.
Myriad Launches Hereditary Cancer Panel to Early-Access CustomersAs the company previously said, it will initially launch its panel as an early-access product to 250 healthcare providers. According to a company spokesperson, by early next year it will expand its access phase. The myRisk panel targets 25 genes associated with an increased risk for eight different hereditary cancers — melanoma, breast, ovarian, colon, endometrial, pancreatic, prostate, and gastric. The company uses the RainDance Thunderstorm to amplify the 25 genes. Sequencing is done primarily on the Illumina HiSeq 2500 to 1,000-fold coverage and variants are called via in-house developed software. Sanger sequencing is used to fill in any gaps and to confirm point mutations. Deletions and duplications are called from the sequencing data and confirmed with microarray. The test will have a turnaround time of 14 days and a list price between $4,000 and $4,500.
Post-Market AEs Emerge With New AntimicrobialsNewly approved antimicrobial agents may carry significant and unlabeled risk of adverse events, researchers reported here. Among 11 antimicrobial agents approved by the FDA from 2006 to 2012, four products were associated with reports of serious adverse events, according to Tina Khadem, PharmD, of the University of Rochester Medical Center in New York, and colleagues.
C. Difficile Infections Rising, Deaths Leveling OffRates of Clostridium difficile infection (CDI) nearly doubled in a decade in US hospitals, results of a new survey show. The diarrhea-causing bacteria, which often occur as a complication of treatment with antibiotics, affected about 2.2 million people during a 10-year period. These data are "the first I'm aware of to look at trends in mortality and length of hospital stay among patients with CDI," said Kelly Daniels, PharmD, a graduate student at the University of Texas at Austin.
Chemists Find New Way to Put the Brakes on CancerUS scientists are looking for the new targets and next generation of therapeutics to stop cancer nationwide. A new platform for drug discovery has been developed through a collaborative effort linking chemists at NYU and pharmacologists at USC. In a study appearing in Proceedings of the National Academy of Sciences, the research groups of Paramjit Arora, a professor in NYU’s Department of Chemistry, and Bogdan Olenyuk from the USC School of Pharmacy have developed a synthetic molecule, “protein domain mimetic,” which targets the interaction between two proteins, called transcription factor-coactivator complex at the point where intracellular signaling cascade converges resulting in an up-regulation of genes that promote tumor progression. This approach presents a new frontier in cancer research and is different from the typical search for small molecules that target cellular kinases.
Leptin leads to an essential discovery
Researchers from UNIGE's Faculty of Medicine conducted experiments on rodents devoid of insulin, to which they administered leptin, a hormone that regulates the body's fat reserves and appetite. Thanks to the leptin, all the subjects survived their insulin deficiency. Using leptin offers two advantages: it does not provoke hypoglycemia and it has a lipolytic effect. 'Through this discovery, the path to offering an alternative to insulin treatment is emerging. Now we need to understand the mechanisms through which leptin affects glucose level, regardless of insulin level,' explains Professor Coppari. Through this discovery, scientists now know where to look for the answer to an insulin-free diabetes treatment.
Vaccine 'Clears HIV-like Virus' in MonkeysA vaccine for the monkey equivalent of HIV appears to eradicate the virus, a study suggests. Research published in the journal Nature has shown that vaccinated monkeys can clear Simian Immunodeficiency Virus (SIV) infection from their bodies. It was effective in nine of the 16 monkeys that were inoculated. The US scientists say they now want to use a similar approach to test a vaccine for HIV in humans. Prof Louis Picker, from the Vaccine and Gene Therapy Institute at Oregon Health and Science University, said: "It's always tough to claim eradication - there could always be a cell which we didn't analyse that has the virus in it. But for the most part, with very stringent criteria... there was no virus left in the body of these monkeys."
'Body on a Chip' Uses 3D Printed Organs to Test VaccinesMiniature human organs developed with a modified 3D printer are being used to test new vaccines in a lab in the US. The "body on a chip" project replicates human cells to print structures which mimic the functions of the heart, liver, lung and blood vessels. The organs are then placed on a microchip and connected with a blood substitute, allowing scientists to closely monitor specific treatments. The US Department of Defense has backed the new technology with $24m (£15m). Bioprinting, a form of 3D printing which, in effect, creates human tissue, is not new. Nor is the idea of culturing 3D human tissue on a microchip. But the tests being carried out at the Wake Forest Institute for Regenerative Medicine in North Carolina are the first to combine several organs on the same device, which then model the human response to chemical toxins or biologic agents.
Vitamin D Cuts Kids' Recurrent Ear InfectionChildren with low levels of vitamin D and recurrent ear infections had a reduced risk for acute otitis media with vitamin D supplementation, researchers reported here. Compared with children randomized to placebo, patients with recurrent acute otitis media (AOM) who received 1,000 IU daily had significantly lower risk of experiencing one or more episodes of AOM (26 incidents versus 38 incidents, P=0.03), and the risk of uncomplicated acute otitis media was markedly smaller in the vitamin D group (P<0 .001="" a="" according="" agents="" and="" anti-microbial="" as="" at="" can="" check="" chemotherapy.="" children="" clinical="" colleagues.="" condition="" conference="" consider="" d="" degli="" di="" during="" esposito="" for="" in="" interscience="" it="" italy="" levels="" low="" md="" means="" media="" milano="" n="" of="" on="" otitis="" p="" practice="" presentation="" recurrent="" said="" serum="" she="" studi="" supplement="" susanna="" that="" the="" their="" this="" those="" to="" treatment="" universita="" use="" vitamin="" we="" with=""> Source: http://www.medpagetoday.com/
Middle-Aged Men, Too, Can Blame Estrogen for That WaistlineThe discovery of the role of estrogen in men is “a major advance,” said Dr. Peter J. Snyder, a professor of medicine at the University of Pennsylvania, who is leading a big new research project on hormone therapy for men 65 and over. Until recently, testosterone deficiency was considered nearly the sole reason that men undergo the familiar physical complaints of midlife.
The new frontier of research involves figuring out which hormone does what in men, and how body functions are affected at different hormone levels. While dwindling testosterone levels are to blame for middle-aged men’s smaller muscles, falling levels of estrogen regulate fat accumulation, according to a study published in The New England Journal of Medicine, which provided the most conclusive evidence to date that estrogen is a major factor in male midlife woes. And both hormones are needed for libido. “Some of the symptoms routinely attributed to testosterone deficiency are actually partially or almost exclusively caused by the decline in estrogens,” said Dr. Joel Finkelstein, an endocrinologist at Harvard Medical School and the study’s lead author, in a news release.
Genes Tied to High Blood Pressure Found in Black AmericansStudy findings may lead to discovery of useful targets for new treatments, researcher says
Black Americans are more likely to develop high blood pressure than whites, and now a large new study has pinpointed four common genetic variations affecting their risk. The study included nearly 30,000 black Americans at 19 sites across the United States and is the largest study to look at how genes influence blood pressure in black people, according to the researchers. The investigators pointed out that most gene discoveries to date have been in white people and noted that previous studies in blacks failed to identify any genes associated with blood pressure.
Health Kick 'Reverses Cell Ageing'Going on a health kick reverses ageing at the cellular level, researchers say. The University of California team says it has found the first evidence a strict regime of exercise, diet and meditation can have such an effect. But experts say although the study in Lancet Oncology is intriguing, it is too early to draw any firm conclusions. The study looked at just 35 men with prostate cancer. Those who changed their lifestyle had demonstrably younger cells in genetic terms.
Left-Handed? That May Have Happened in the WombNew research from scientists at the Universities of Oxford, St Andrews, Bristol and the Max Plank Institute in Nijmegen, the Netherlands reveals a network of genes that are likely associated with establishing a left- or right-handed bias in embryos. Only about 10% of humans are left-handed, and previous theories focused on everything from which thumb babies start sucking in the womb, to the role of hormones like testosterone But by conducting a genome-wide association study — in which scientists compare a wide array of genetic differences in right- and left-handed people — in four different population groups, the research team found that variants in the gene PCSK6 contributes to handedness determination.
Antibiotic-Resistant Infections Lead to 23,000 Deaths a Year, C.D.C. FindsFederal health officials reported that at least two million Americans fall ill from antibiotic-resistant bacteria every year and that at least 23,000 die from those infections, putting a hard number on a growing public health threat. It was the first time that federal authorities quantified the effects of organisms that many antibiotics are powerless to fight. The number of deaths is substantially lower than previous estimates, in part because researchers from the Centers for Disease Control and Prevention stripped out cases in which a drug-resistant infection was present but not necessarily the cause of death.
UN: 6.6 Million Children Under 5 Died Last YearChildhood death rates around the world have halved since 1990 but an estimated 6.6 million children under the age of 5 still died last year, the U.N. children's agency said. Nearly half of all children who die are in five countries: Nigeria, Congo, India, Pakistan and China, it said in a report. "Progress can and must be made," said Anthony Lake, UNICEF's executive director.
United States Ranks 11th in Plague Cases WorldwideThe United States now ranks 11th in the world in cases of plague, according to a new survey of the disease. With 57 cases in a decade, it is far below the hardest-hit countries, Congo with 10,581 and Madagascar with 7,182. Still, it is the only wealthy country on the list; 97 percent of cases are in Africa. The survey was published by The American Journal of Tropical Medicine and Hygiene.
Teenagers Are Getting More Exercise and VegetablesTeenagers are exercising more, consuming less sugar and eating more fruits and vegetables, a trend that may be contributing to a leveling off of obesity rates, a new study shows. The findings suggest that aggressive anti-obesity messages aimed at children may be starting to make a difference, albeit a small one. The study was published in the journal Pediatrics. Still, most teenagers were falling short of federal recommendations, which call for children to get at least an hour of physical activity daily, a central message of Michelle Obama’s signature “Let’s Move” campaign.
Hospital MRSA Infections Fall by More Than 50%, Report ShowsCases of methicillin-resistant Staphylococcus aureus (MRSA) infections acquired in U.S. hospitals dropped nearly 54% from 2005-2011, according to a new government study. That good news came as the Centers for Disease Control and Prevention issued a separate report cataloging depth and variety of drug-resistant bacterial threats, concluding that they kill at least 23,000 people and add $20 billion in healthcare costs a year. In a report published in the Journal of the American Medical Association, CDC researchers estimated a general decline of about 28% in severe MRSA infections, falling to 80,461 in 2011, after rising at an alarming rate in the previous decade.
Hospital Association Leaders Push Members to Educate Patients About ExchangesWith open enrollment on the public exchanges starting soon, the leaders of the nation's major hospital associations urged their members to do all they can to help patients learn about the health reform law's insurance coverage options. Dr. Mandy Cohen, senior adviser to the CMS administrator, told the participating hospital officials that HHS continues to focus its outreach efforts on the “younger cohort”—the 17.8 million uninsured individuals between the ages of 18 and 35—of whom more than 90% will be eligible for some sort of financial benefit for health insurance. Meanwhile, Cohen said, HHS continues to concentrate on eight states where more than 50% of the nation's uninsured individuals reside: California, Florida, Georgia, Illinois, New York, North Carolina, Ohio and Texas.
Not All Doctors Giving Up Private Practice“To paraphrase Mark Twain, the reports of the death of private practice medicine have been greatly exaggerated,” Dr. Ardis Dee Hoven, president of the American Medical Association, said in a news release touting the findings of a recent survey that indicates how the trend toward hospital employment of physicians may be overstated. According to the AMA's new Physician Practice Benchmark Survey (PDF), 53.2% of physicians were self-employed in 2012, 41.8% were employed and 5% were independent contractors. The findings are touted as a counterpoint to recent surveys that suggest physicians are flocking to the security of salaried positions and selling practices to hospitals as the demands of care coordination and health information technology continue to mount. The AMA report cited an American Hospital Association study that found physicians employed by community hospitals increased 32% to 212,000 from 160,000 between 2000 and 2010. The need to preserve and support private physician practices has been a rallying cry at recent annual meetings of the AMA House of Delegates.
ACP: 5 Reasons Meaningful Use is Burdensome to DocsThe American College of Physicians, in a letter addressed to federal health officials, says that the "very aggressive" timeline and "overly ambitious" objectives of Meaningful Use Stage 2 threaten to limit the success of the overall program. In the letter--sent to U.S. Department of Health & Human Services Secretary Kathleen Sebelius, Centers for Medicare& Medicaid Services Administrator Marilyn Tavenner and National Coordinator for Health IT Farzad Mostashari--ACP Medical Informatics Committee Chair Peter Basch (pictured) adds that relying on "evolving and draft standards" and untested technology could create "unintended consequences" and "additional costs" for physicians.
The letter outlines five areas of concern for ACP members, including:
- The Stage 2 timeline
- Clinical quality measures
- ICD-10 and physician quality reporting systems
- Scoring Meaningful Use measures
- Planning for Stage 3
First, it seeks to define common attributes that achieve high positive match rates across disparate systems. "These attributes may include common fields such as name, date of birth, address, sex, cell phone number and new criteria such as emergency contact and insurer," he wrote.
Second, the project hopes to define the processes and best practices that are most effective to support high positive patient matching rates utilizing these attributes.
Consumer Health IT Summit, Park described Blue Button as a “movement” -- embraced by individual doctors, large health care providers and insurers -- that allows patients to access their data and share it with their clinicians and family members. As of next Monday new regulations will require clinicians to offer patients records in an electronic format for a nominal fee, according to Leon Rodriguez, director of the HHS Office for Civil Rights. He emphasized that under the Health Insurance Portability and Accountability Act, or HIPAA, patients are entitled to their records, whether electronic or paper.
Consumers Get Serious About Their EMRsAs patient engagement grows, a new survey indicates that a growing number of U.S. consumers (41 percent) would be willing to switch doctors to gain online access to their own electronic medical records. Doctors, though, are not as eager to make the change. The survey, of more than 9,000 people in nine countries, shows that only about a third of U.S. consumers (36 percent) currently have full access to their EMR, but more than half (57 percent) have taken ownership of their record by self-tracking their personal health information, including their health history (37 percent), physical activity (34 percent) and health indicators (33 percent), such as blood pressure and weight.
Grants to Boost Rural HIT Workforce, Improve Care for VetsThe U.S. Department of Health & Human Services has announced grants of nearly $5.3 million to expand the health IT workforce in rural areas and to improve mental health services for veterans in rural areas. Organizations such as community colleges working with local providers in 15 states will receive nearly $4.4 million to recruit and train workers, providing not only electronic health record technology certifications, but also apprenticeships and job opportunities.
VA Researching Natural Language Processing in EHRs to Prevent SuicideThe U.S. Department of Veterans affairs, is researching the use of natural language processing within its electronic health records system to automate suicide risk alerts. According to an announcement from the VA, natural language processing is "part of the technology that makes Google work," and ongoing research at the VA Puget Sound Health System and the University of Washington is seeking to learn how the VA can use it.
Wireless Health Market Poised for GrowthThe global wireless health market has hit growth mode, according to new report findings, which project the market will expand more than 20 percent within a five-year period. The report, conducted by Research and Markets, pegs the wireless health market currently at $23.8 billion, expected to reach $59.7 billion by 2018, the growth being attributed to the uptick in remote patient monitoring applications and diagnostics, aging populations and growing hospital deficits. Wireless network technologies represent the largest market segment and will continue to be the largest contributor over the next five years, researchers say.
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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