A Weekly Compilation of Clinical Laboratory and Related Information
from The Division of Laboratory Science and Standards
November 21, 2013
View Previous Issues - Healthcare News Archive
The Centers for Disease Control and Prevention received accreditation from the Emergency Management Accreditation Program (EMAP) for its excellence in emergency management. CDC is the first federal agency to attain full accreditation of its emergency management program. “CDC’s emergency management program has seen the nation through flu emergencies, multistate foodborne outbreaks, hurricanes and more,” said CDC Director Tom Frieden, M.D., M.P.H. “CDC is the first federal agency to attain full accreditation of its emergency management program.”
“Salaries continue to rise and that is good news,” says Andrea Bennett, MPH, MT (ASCP), Director of the ASCP Center for Public Policy and Chair of the ASCP Task Force on the Laboratory Professionals Workforce. “We still see that for most of the lab professionals, being certified makes a difference in wages." Published in the Fall 2013 issue of Lab Medicine, the ASCP Wage survey provides current wage data for U.S.-based laboratory scientists. The 2013 Wage Survey indicates that the average age for laboratory professionals is 44, down from 48 within the last five years. “We are seeing an increasing number of younger people entering the profession,” Ms. Bennett says. The report provides useful geographical information, including states with highest and lowest pay for specific job categories
So-called patients-in-waiting have genes for disease but no symptoms
The expanding use of genetic testing is having an unforeseen consequence: More people are being told they have genes for potentially fatal diseases but don't show any symptoms. Experts call these people patients-in-waiting. They can live in medical limbo for years while they and their doctors wonder if and when a disease, such as cystic fibrosis, will develop. Coming down with a simple cough or fever may prompt some patients to fear it is an early sign of a disorder. Another dilemma: Doctors are sharply divided about whether to begin treatment in hopes of preventing the disease's onset.
Nearly a third of all laboratory blood tests are unnecessary while a similar number of tests that could prove to be useful are not being conducted, a new study published in the journal PLOS ONE and conducted by researchers at Beth Israel Deaconess Medical Center (BIDMC), who analyzed more than 1.6 million results from 46 of medicine's 50 most commonly ordered lab tests, reveals. "Lab tests are used in all medical specialties, affecting virtually all patients," explains senior author Ramy Arnaout, MD, DPhil, Associate Director of the Clinical Microbiology Laboratories in the Department of Pathology at BIDMC and Assistant Professor of Pathology at Harvard Medical School (HMS). "While working with my clinical colleagues around the hospital, I often found myself wondering about the appropriateness or inappropriateness of all of these tests. In developing this study, my coauthors and I wanted to learn more about overall lab test utilization so that we could better understand how and where errors were occurring in this extremely high-volume activity."
Their findings revealed a stark problem: Not only was there a 30 percent overall rate of test overuse- there was a similar rate of underuse.
The Infectious Diseases Society of America has called for better diagnostics for infectious diseases, outlining goals that require collaborative efforts between Congress, regulatory bodies, industry, professional societies and clinicians.
The report describes six recommendations to help meet the goal of improving diagnostics for infections:
- Stimulate diagnostics research and development;
- Expedite integration of improved diagnostics tests into patient care;
- Address regulatory challenges to diagnostics research and development;
- Ensure appropriate levels of reimbursement for diagnostic testing;
- Encourage adoption of new tests; and
- Educate health care providers on the use of diagnostics.
Rapid influenza diagnostic tests both decreased antibiotic prescriptions and increased antiviral use, according to study results published in the Journal of the Pediatric Infectious Diseases Society. “When results of influenza tests are available to physicians at the ‘point of care,’ they use this information to provide more appropriate patient management,” Anne J. Blaschke, MD, PhD, of the University of Utah School of Medicine, said in a press release. “While other studies have shown that physicians can accurately diagnose influenza without testing, our results suggest that using an influenza test increases diagnostic certainty and leads to the physician providing more specific and appropriate care.”
The first step for women with a history of urinary tract infections may be skipping a standard test isn't that good at spotting bladder infections anyway. "Fewer tests should be done," says Dr. Michael Donnenberg, a professor of medicine at The University of Maryland School of Medicine who wasn't involved in the study. "It's even a poorer test than we thought." Urinary tract infections lead to 8 million doctor visits a year, according to the Centers for Disease Control and Prevention. That adds up to plenty of expense and inconvenience that in many cases may not be worth the trouble. The urine culture, formally called a midstream urine culture, accurately identified most women who had bladder infections with E. coli bacteria, which cause at least three-quarters of infections, the study found. But the test missed women who had infections with other bacteria, or had low levels of E. coli that were still enough to make the women sick.
Unfortunately, doctors don't have a more accurate test to replace the urine culture.
Simple Blood Test for Sub-Type Specific Lung Cancer Diagnosis
Lung cancer is the leading cause of cancer specific death worldwide. 85% lung cancers are non-small cell lung cancers (NSCLC) while remaining are small cell lung cancers (SCLC). An international team of researchers from India, UK, Spain, Brazil, and the USA led by Debmalya Barh from the Institute of Integrative Omics and Applied Biotechnology (IIOAB) in Nonakuri, Tamluk, Purba Medinipur, West Bengal, India have identified blood based novel diagnostic markers those can be useful in early detecting the lung cancer and even their sub-typing i.e. whether its SCLC or NSCLC. The study has been recently published in BMC Genomics 14 (Suppl 6), S5, 25 Oct, 2013.
Machines Learn to Detect Breast Cancer
Software that can recognize patterns in data is commonly used by scientists and economics. Now, researchers in the US have applied similar algorithms to help them more accurately diagnose breast cancer. The researchers outline details in the International Journal of Medical Engineering and Informatics. The team suggested that just such an automated statistical analysis methodology might readily be adapted to a clinical setting. The machine learning approach takes into account nine characteristics of a minimally invasive fine needle biopsy. The statistical model thus developed could then be used to test new tissue samples for malignancy.
Parent's Use of Digital Photography Shown as an Effective Tool in Diagnosis of Retinoblastoma
Can parents use digital cameras and smart phones to potentially screen their children for the most common form of pediatric eye cancer? Baylor University and Harvard Medical School researchers believe so. In their study, published online in PLOS ONE, the researchers discovered, through the use of amateur digital photography, evidence of leukocoria or "white eye," the cardinal symptom of retinoblastoma, which can be seen in photographs during the earliest stages of the disease. Their findings potentially pave the way for a new diagnostic tool that enables earlier diagnosis and treatment. Retinoblastoma, mostly occurring in children from birth to 5-years-old, is an aggressive eye cancer that, if not treated in time, can be fatal if it spreads to the brain.
Genomic Health Officials Discuss Continued Growth of Oncotype DX Tests
Genomic Health officials said that more than three hundred doctors had ordered its Oncotype DX prostate cancer test, many of whom have placed repeat orders. The Oncotype DX prostate cancer test analyzes the expression of 17 genes within four biological pathways to gauge prostate cancer aggressiveness. The test reports a genomic prostate score from 0 to 100; the lower the score the more certain a patient can be that they can avoid treatment and continue with active surveillance. If, based on standard clinical measures, a person's prostate cancer is considered high risk, then he is not a candidate for Genomic Health's test. Researchers from Genomic Health published the abstract of an analytical validation study on the prostate cancer test in BMC Genomics in October. Researchers led by Genomic Health's Dejan Knezevic reported that the test could analyze as little as 5 ng of RNA. The investigators gauged reproducibility and precision of the test by testing 10 prostate cancer samples across multiple instruments, different reagent lots, days, and RNA input levels.
Children's Mercy Hospital Launches Targeted NGS Test for Childhood Disorders
Children's Mercy Hospital has launched a next-generation sequencing-based test that assesses the coding regions of 514 genes implicated in more than 750 severe childhood-onset diseases. In a platform presentation at the American Society of Human Genetics conference last month, Sarah Soden, medical director of the Center for Pediatric Genomic Medicine at CMH, presented data from 107 patients with neurodevelopmental disorders who had been screened with either the panel, exome sequencing, or whole-genome sequencing. Children's Mercy is now offering the customized panel — dubbed TaGSCAN for Targeted Gene Sequencing and Customized Analysis — as a commercial diagnostic test. Additionally, it has a research protocol to provide exome sequencing, and under a National Institutes of Health grant is offering its rapid whole-genome sequencing test, STAT-seq, in the neonatal intensive care unit (CSN 9/25/2013). Carol Saunders, director of laboratory compliance, test interpretation, and reporting, told Clinical Sequencing News that within the next three to six months, CMH plans to launch an expanded version of the TaGSCAN test that includes an additional 25 genes plus the entire mitochondrial genome. The current version of TaGSCAN costs $3,200 or less, and has a turnaround time of six to eight weeks.
Tissue Cryopreservation for Medical Care Moves Forward
Developing an efficient way to freeze and store living tissues could transform many aspects of medical care and research, but ice crystallization often occurs within cells during such cryopreservation procedures, leading to cell death. In the Biophysical Journal, a Cell Press publication, researchers report that they have gained new information about the processes that are responsible for promoting the freezing of cells within tissues. This knowledge may ultimately lead to novel approaches for preventing tissue injury during cryopreservation.
Quality and efficiency metrics, more than ever before, are critical to managing clinical practice, patient outcomes and maximizing reimbursement realization. At Family Practice Center in Middleberg, Pennsylvania - an all-purpose laboratory serving 27 physician sites across central Pennsylvania - we approached an increase in lab volume with an open perspective and as an opportunity to establish workflow improvements using these five steps.
- Break Down Siloes:
- Standardizing Practices:
- Standardizing and Automating Complex Decision Making:
- Automating Processes to Increase Human Capital Utilization:
- Understanding the Value of Dashboarding
While there are many ways to improve workflow in the clinical laboratory, through these five steps transforming the lab from a cost center to a revenue center is possible and not limited to the lab alone.
Could Vaccines Someday Improve Heart Health?
In early studies, injections lowered cholesterol and blood pressure in animals.
Two animal studies suggest that vaccines might someday be used to reduce high cholesterol levels and lower blood pressure, according to findings presented at the American Heart Association (AHA) annual meeting in Dallas. In both cases, the vaccines interrupt processes in the body that, if left alone, can lead to high cholesterol and elevated blood pressure. The first study, out of Vienna, found that mice and rats had lower cholesterol levels for a year following treatment with a vaccine that protects a cell's ability to remove "bad" LDL cholesterol from the bloodstream. "This is one of the most exciting things that's now under development in the controllability of cholesterol," said Dr. James Howard, an AHA spokesperson and an endocrinologist and internist at MedStar Washington Hospital Center in Washington, D.C.
A Valuable Weapon in War Against Drug-resistant Superbugs: Antibiotic Offers Hope
A new kind of antibiotic that causes microbes to digest themselves has been developed by scientists who believe it could become a valuable weapon in the war against drug-resistant “superbugs”. Laboratory tests show that the drug is effective against persistent strains of the Staphylococcus bacterium and is able to cure laboratory mice of the same kind of chronic bacterial infections that have killed hospital patients. Kim Lewis of Northeaster University in Boston, Massachusetts, said that the drug, called acyldepsipeptide (ADEP4), works by activating an enzyme within the dormant “persister” cells of the bacteria, which causes these hardened microbial cells to self-digest. The study, published in the journal Nature, demonstrated however that when ADEP4 is used in conjunction with a conventional antibiotic, such as rifampicin, it is very effective at ridding an infection of the persister cells that are often left untouched by the treatment.
Bacterial Competition in Lab Shows Evolution Never Stops
Evolution is relentless process that seems to keep going and going, even when creatures live in a stable, unchanging world. That's the latest surprise from a unique experiment that's been underway for more than a quarter-century. It turns out, though, that the bacteria haven't stopped evolving, and it looks like they never will, according to a report Lenski's group has now published in the journal Science. What they've found is that the bacteria just keep getting fitter and fitter and fitter. The pace of improvement is slowing down, but shows no sign of stopping.
Microbes in the Gut Help Determine Risk of Tumors
Transferring the gut microbes from a mouse with colon tumors to germ-free mice makes those mice prone to getting tumors as well, according to the results of a study published in mBio®, the online open-access journal of the American Society for Microbiology. The work has implications for human health because it indicates the risk of colorectal cancer may well have a microbial component. "We know that humans have a number of different community structures in the gut. When you think about it, maybe different people - independent of their genetics - might be predisposed," says Joseph Zackular of the University of Michigan, an author on the study. Co-author Patrick Schloss, also of the University of Michigan, was somewhat surprised by the clarity of the results. "We saw more than two times the number of tumors in mice that received the cancerous community [than in mice that received a healthy gut community]," says Schloss. "That convinced us that it is the community that is driving tumorigenesis. It's not just the microbiome, it's not just the inflammation, it's both."
Looking at the microorganisms, they found that tumor-bearing mice harbored greater numbers of bacteria within the Bacteroides, Odoribacter, and Akkermansia genera, and decreased numbers of bacteria affiliated with members of the Prevotellaceae and Porphyromonadaceae families
This study shows that HPV can damage genes and chromosomes directly, revealing a new way by which HPV might contribute to cancer development. The virus that causes cervical, head and neck, anal and other cancers can damage chromosomes and genes where it inserts its DNA into human DNA, according to a new study led by researchers at The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James). It’s long been known that cancer-causing types of human papillomavirus (HPV) produce two viral proteins, called E6 and E7, which are essential for the development of cancer. However, they are not sufficient to cause cancer. Additional alterations in host-cell genes are necessary for cancer to develop. Here, scientists identified a new mechanism by which HPV may damage host DNA directly and contribute to cancer development.
Digging Deeper Into Cancer
What a pathologist looks for in a Pap test sample, but hopes not to find, are oddly shaped cells with abnormally large nuclei. The same is true for prostate and lung cancer biopsies. “If you just open a text on the pathology of cells, you see hundreds of strange-looking cells – this one with a gigantic nucleus, that one with vacuoles that push the nucleus aside,” says Wallace Marshall, PhD ’97, an associate professor of biochemistry and biophysics. “It’s like an atlas of freakish cells.” Marshall wondered if this lineup of distorted cells might hold a clue to a new way to fight cancer. Marshall thought of a different strategy: what if the enlarged nuclei, and specialized cellular structures called organelles, actually drive cancer metabolism? If so, then developing ways to reverse organelle growth could rob cancer cells of the proteins and other resources they need to grow and proliferate.
Clotting Gene Gives Clue to Black Heart Disease
Black Americans are twice as likely to develop heart disease as white Americans, and a gene may yield a clue as to why, a new study has found. According to the New Scientist, the fragments in the blood, or platelets, form blood clots—components of heart disease and heart attack—more easily in African Americans. "Unexpectedly, we found that platelets from black donors clotted faster and to a greater extent in response to the naturally occurring clotting agent, thrombin," Paul Bray of Thomas Jefferson University in Philadelphia told the New Scientist. "This provides a new understanding of the effects of race on heart disease and other blood-clot related illnesses," added Bray, who led the work.
Nipah Protein Structure Revealed
The structure of a key protein of the deadly virus could serve as a stepping stone to antiviral therapy. The Nipah virus phosphoprotein, P, plays a key role in viral replication. Therefore, understanding its structure may shed light on ways to disrupt the viral life cycle. “If you can prevent the virus from making more RNA, then it can’t replicate, which is a good strategy for developing antiviral medications,” Jessica Bruhn, a graduate student in Erica Ollmann Saphire’s lab at Scripps Research Institute in La Jolla, California, said in a press release.
Two Genes May Accelerate Wound Healing in the Young
The mystery of why wounds heal more quickly in the young compared to the elderly may soon be solved following the discovery of two of the genes involved in tissue regeneration. The scientists believe that the genes, called Lin28a and IMP1, are designed to be especially active during the foetal stages of development and are gradually turned off as an animal ages - which could explain why wounds take longer to heal in the elderly and how ageing occurs.
Vitamin D for Healthy Kidney Transplants
A new study suggests that getting enough of a crucial vitamin may be essential for maintaining kidney health after a transplant. The study showed that vitamin D levels were directly related to how well patients' kidneys filtered waste out of the blood in the years after transplant surgery. Patients with lower levels of vitamin D were more likely to have an organ rejection.
Depression 'Makes us Biologically Older'
Lab tests showed cells looked biologically older in people who were severely depressed or who had been in the past. These visible differences in a measure of cell ageing called telomere length couldn't be explained by other factors, such as whether a person smoked. The findings, in more than 2,000 people, appear in Molecular Psychiatry.
More Than Skin Deep: New Layer to the Body's Fight Against Infection
The layers of skin that form the first line of defense in the body’s fight against infection have revealed a unanticipated secret. The single cell type that was thought to be behind the skin’s immune defense has been found to have a doppelganger, with researchers from the Walter and Eliza Hall Institute showing the cells, despite appearing identical, are actually two different types. Institute scientists Dr. Michael Chopin, Dr. Stephen Nutt and colleagues from the institute's Molecular Immunology division have been investigating Langerhans cells, the immune cells that provide the first line of defence against attacks through the skin. Until recently, scientists believed that, because they looked identical, all Langerhans cells were also genetically identical and had the same function. However Nutt says the research team, with collaborators from the National Institutes of Health have shown this is not the case.
AAP Releases New Principles for URI Antibiotics
Effective use of antibiotics to treat pediatric upper respiratory tract infections (URIs) rests on 3 basic principles: accurate diagnosis, consideration of risks vs. benefits, and recognizing when antibiotics may be contraindicated, according to a clinical report by the Committee on Infectious Diseases of the American Academy of Pediatrics (AAP). Of the nearly 50 million pediatric antibiotic prescriptions written annually, as many as 10 million of those "are directed toward respiratory conditions for which they are unlikely to provide benefit," lead author Adam L. Hersh, MD, PhD, and fellow committee members write in an article published in the December issue of Pediatrics. The report emphasizes "the importance of using stringent and validated clinical criteria when diagnosing acute otitis media (AOM), acute bacterial sinusitis, and pharyngitis caused by group A Streptococcus (GAS), as established through clinical guidelines," the authors write.
Princeton U. to Give Students Meningitis B Vaccine
Princeton University students will soon be able to get a vaccination against a rare and sometimes deadly form of meningitis that has infected six students and a campus visitor since March. Campus officials told students in an e-mail that they hope to make the first of two doses available by early December and the second in February. The vaccinations are to be paid for by the university and are not required. The e-mail message said the Centers for Disease Control and Prevention "is preparing to recommend" that all Princeton undergraduates, along with graduate students who live in campus housing, receive a vaccine that helps protect against meningococcal disease caused by serogroup B.
The CDC says the outbreak at Princeton is the first in the world since the vaccine, Bexsero, against the type B meningococcal bacteria was approved in Europe and Australia this year, the only one for use against the strain.
The Biggest Mistake Doctors Make
Misdiagnoses are harmful and costly. But they're often preventable.
A patient with abdominal pain dies from a ruptured appendix after a doctor fails to do a complete physical exam. A biopsy comes back positive for prostate cancer, but no one follows up when the lab result gets misplaced. A child's fever and rash are diagnosed as a viral illness, but they turn out to be a much more serious case of bacterial meningitis. Such devastating errors lead to permanent damage or death for as many as 160,000 patients each year, according to researchers at Johns Hopkins University. Not only are diagnostic problems more common than other medical mistakes—and more likely to harm patients—but they're also the leading cause of malpractice claims, accounting for 35% of nearly $39 billion in payouts in the U.S. from 1986 to 2010, measured in 2011 dollars, according to Johns Hopkins. The good news is that diagnostic errors are more likely to be preventable than other medical mistakes. And now health-care providers are turning to a number of innovative strategies to fix the complex web of errors, biases and oversights that stymie the quest for the right diagnosis.
Researchers who want to study population health using the vast stores of Medicare and Medicaid data will no longer have to order it and wait for the federal government to ship them encrypted data files. Rather, they can now access the information virtually, the Centers for Medicare & Medicaid Services (CMS) announced. Researchers using the VRDC will access CMS data from their own workstations and will be able to perform analyses and manipulate data within the VRDC. The VRDC will help CMS meet these demands while also ensuring data privacy and security and reducing the cost of data access for most users.
AHRQ: Health IT Can Improve Care Coordination for Complex Conditions
Ten research projects aimed at using health IT to improve care in ambulatory settings for patients with complex healthcare needs demonstrated improvements in care coordination, data sharing and patient engagement. Called the Improving Management of Individuals With Complex Healthcare Needs Through Health IT initiative, it's one of five grant programs from the Agency for Healthcare Research and Quality (AHRQ) focused on using health IT to improve care.
New findings confirm that electronic health records deliver benefits for patients and physicians. A September study by one of Kaiser Permanente’s research arms shows that when doctors switched from paper to digital records, their diabetic patients made 5.5 percent fewer trips to the emergency room and were hospitalized 5.3 percent fewer times. These modest gains added up to savings of $158,478 for every 1,000 patients. “There’s something about being in an integrated system that allows everything to work better,” says Marc Jaffe, a Kaiser Permanente endocrinologist who is a co-author of the study. Next year will be “a make-or-break year” for electronic health records, says Dr. Farzad Mostashari, who stepped down in October as national coordinator for health IT at the U.S. Department of Health and Human Services. “In the past three years, we’ve been busy putting the systems in place,” says Mostashari, now a Brookings Institution visiting fellow. By 2014 these platforms are expected to be able to interoperate, which means “talk to each other and to patients,” he says.
6 Predictions for How Health IT Will Impact Healthcare in 2014
With the increasing difficulty for providers to meet Meaningful Use stage 2 requirements centered on patient engagement, 2014 will be a big year of disruption in the health IT industry.
Practice Fusion’s key predictions for 2014 include:
1. Health IT incentives are here to stay
2. Many practices will switch their EHR solutions
3. Health care will become more networked
4. Billing will be easier in the cloud with ICD-10
5. EMRs will power accountable care
6. Independent practices will emerge as the vanguard of innovation
ECRI: 10 Top Health Tech Dangers
The health IT hazard that tops the ECRI Institute's top hazards list for 2014 is a recurring one, having been singled out by many safety organizations as something to beware.
Top 10 hazards:
1. Alarm hazards
2. Infusion pump medication errors
3. CT radiation exposure in pediatric patients
4. Data integrity failures in EHRs and other health IT systems
5. Occupational radiation hazards in hybrid ORs
6. Inadequate reprocessing of endoscopes and surgical instruments
7. Neglecting change management for networked devices and systems
8. Risks to pediatric patients from "adult" technologies
9. Robotic surgery complications due to insufficient training
10. Retained devices and unretrieved fragments
Docs Blame EHRs for Lost Productivity
Nearly 60 percent of ambulatory providers surveyed for a new IDC Health Insights report say they're unsatisfied with their electronic health records, citing frustrations with usability and workflow. IDC's new study, "Business Strategy: The Current State of Ambulatory EHR Buyer Satisfaction," polled 212 ambulatory and hospital-based providers. It found that while the adoption of EHRs is widespread, the experience of most who use them "is one of dissatisfaction." According to results, 58 percent of ambulatory providers surveyed were dissatisfied, very dissatisfied, or neutral about their experience with ambulatory EHRs. Issues affecting EHR productivity include poor usability, inappropriate form factors and user interfaces, access to mobile technology, workflow tools and configurations, inadequate training, inadequate staffing and support, inefficient processes and application uptime and availability, according to the report.
EHR Copy and Paste? Better Think Twice
Who would have thought that something so simple as copy and paste could have such serious consequences? Speaking at the October MGMA annual conference in San Diego, Diana Warner, director at AHIMA, confirmed the seriousness of inappropriately using copy and paste functions in electronic health records. And the government agrees -- it's no laughing matter. Seventy-four to 90 percent of physicians use the copy/paste function in their EHRs, and between 20 to 78 percent of physician notes are copied text, according to a September AHIMA report. It's become such a compliance and payment problem that the U.S. Department of Health and Human Services Secretary Kathleen Sebelius together with Attorney General Eric Holder wrote a letter last year to industry medical groups underscoring the seriousness of doctors "gaming the system, possibly to obtain payments to which they are not entitled."
US, UK Launch Global Public Health Cloud
About half a century after epidemiology studies in Massachusetts and the United Kingdom helped build the world's understanding of cardiovascular disease and health risks, public health and population data is being opened up by the U.S. and joining international datasets. The cloud, hosted by the U.K.-based BT and using software of the Washington-based MedRed, currently hosts deidentified population data from the National Health Services, covering England, Scotland and Wales, with data on demographics, income levels, disease and physician encounters, acute care, medication history, and certain outcomes. With regular updates from the Food the Drug Administration and the Centers for Medicare and Medicaid Services, the database will host adverse event data and Medicare demographics and utilization data, along with other public datasets.
Bill on Drug Compounding Clears Congress a Year After a Meningitis Outbreak
A bill that would give the Food and Drug Administration more power to police compounding pharmacies passed its final hurdle in Congress, in what experts said was an important step to a safer drug supply in the United States. The bill, which cleared the Senate without opposition, stops short of giving the F.D.A. complete authority over pharmacies that tailor-mix drugs for individual patients, a process known as compounding. But the bill still provides significant new safeguards, which have earned it the support of public health advocates around the country. “It has very sharp teeth,” said Sarah Sellers, a drug safety consultant who has tracked the issue for years.
House Bill Pushes Telehealth Expansion for Veterans
A new bill sponsored by Reps. Mike Thompson (D-Calif.) and Scott Peters (D-Calif.) hopes to encourage the use of telehealth for veterans by expanding current telehealth reimbursement policies. The 21st Century Care for Military & Veterans Act (H.R. 3507) is co-sponsored by Reps. Gregg Harper (R-Miss.) and Peter Welch (D-Vt.) and endorsed by the American Telemedicine Association. Peters said telehealth is “increasingly important” to the full range of care options veterans should be receiving. “We’ve already seen that these technologies create a more responsive and more efficient healthcare system that provide for better care and lower costs,” he said in the news release.
Congress Opens Door to Allowing HIV Organ Donations
The House will pass S. 330, the HIV Organ Policy Equity (HOPE) Act, legislation that the Senate passed in June by unanimous consent. The bipartisan bill would re-write language in the Organ Transplant Amendments Act of 1988, which was quickly passed by voice vote in the House and Senate in 1988. That bill, from Sen. Ted Kennedy (D-Mass.), was meant to ensure that organs from HIV patients would not be given to non-HIV patients. However, supporters of this week's bill say the 1988 language is "medically outdated." As HIV patients live longer, many are in need of new organs, and some doctors say they would face a much shorter waiting period if organs from other HIV patients were available.
Representative Marsha Blackburn (R-TN) and five of her colleagues introduced the H.R.3303, the Sensible Oversight for Technology which advances Regulatory Efficiency (SOFTWARE) Act, which would limit Food and Drug Administration (FDA) oversight to high risk medical software, exempting apps geared towards consumers. According to Rep. Blackburn the number of medical apps on smart phones will reach 500 million in 2015. Broad FDA involvement in this area, she asserts, would hinder technological innovation in this fast growing area
FDA Releases Document Outlining Its Role in Personalized Medicine
The Food and Drug Administration (FDA) recently released a report entitled, "Paving the Way for Personalized Medicine: FDA's Role in a New Era of Medical Product Development," which outlines the agency's activities over the past decade to advance the field of personalized medicine. Specifically, the FDA identifies the actions it took to streamline the regulatory process, facilitate collaboration among different groups, and help translate scientific advances into clinical practice. "From FDA's vantage point, the era of personalized medicine has clearly arrived.
FDA Pushes to Fight Drug-resistant Germs
Bacteria can develop resistance to antibiotic drugs over time. A report from the Centers for Disease Control and Prevention earlier this year asserted that there are “potentially catastrophic consequences” of ignoring drug-resistant bacteria, which infect at least 2 million Americans each year. Woodcock, director of the FDA’s drug evaluation and research center, said that Congress should discourage doctors from prescribing antibiotics when they’re not necessary. “We feel that it should be explored that the Congress could make some kind of program that would really send a signal about limited use and good antibiotic stewardship,” she said.
FDA to Ban Artery-clogging Trans Fats
The FDA announced it will require the food industry to gradually phase out artificial trans fats, saying they are a threat to people's health. Commissioner Margaret Hamburg said the move could prevent 20,000 heart attacks and 7,000 deaths each year. Hamburg said that while the amount of trans fats in the country's diet has declined dramatically in the last decade, they "remain an area of significant public health concern." The trans fats have long been criticized by nutritionists, and New York City and other local governments have banned them.
Medicare Penalizes Nearly 1,500 Hospitals for Poor Quality Scores
This year, there are more losers than winners. Medicare has raised payment rates to 1,231 hospitals based on two-dozen quality measurements, including surveys of patient satisfaction and — for the first time — death rates. Another 1,451 hospitals are being paid less for each Medicare patient they treat for the year that began Oct. 1. The bonuses and penalties are one piece of the health care law's efforts to create financial incentives for doctors and hospitals to provide better care. Next year, the quality program gets tougher with more money at stake. Medicare is planning to add new measures next year, including comparisons of how much patients cost Medicare at different hospitals and rates of medical mishaps and infections from catheters. The goal of all these programs is to replace the current financial incentive in Medicare, in which the only way for a hospital to get paid more is to perform more procedures and take on more patients.
New Center Explores Ethical, Legal, Social Implications of Genomics in Health Care
With inexpensive genetics kits flooding the market, both consumers – and their doctors – still lack basic information about what to do, if anything, with what they learn about their own genomes. “In the future, there is the belief that everyone will have their genome sequenced and that information will be used to guide medical care,” said Carol P. Somkin, PhD, research scientist with the Kaiser Permanente Division of Research.
“How do we take basic scientific findings, like mapping of the human genome, and transform them into applications that can help us better understand the causes of disease, their prevention and treatment?” added Barbara Koenig, PhD, professor of medical anthropology and bioethics in the UCSF School of Nursing.
The Importance of Foreign-Educated Health Workers in the US Health System
Foreign-educated and foreign-born health professionals play a vital role in the U.S. health care workforce, but strategic shifts such as changes in immigration laws may be needed to stabilize the nation's health workforce, according to a new RAND Corporation study.
The study outlines the contributions that foreign-educated and foreign-born health professionals make to the U.S. workforce, including:
- Physicians who were educated outside the United States account for about 25 percent of the U.S. physician workforce, with the largest groups being from India, the Philippines, Pakistan, Mexico and the Dominican Republic.
- Foreign-born registered nurses account for 12 percent to 15 percent of the total RNs in the United States, with 5.4 percent both foreign born and foreign educated. The largest number of foreign-educated and foreign-educated RNs are from the Philippines, followed by Canada, India, the United Kingdom and Nigeria.
- Among direct care workers, a category that includes nursing aides and home health aides, foreign-born individuals account for 20 percent to 24 percent of the workforce. The largest numbers of foreign-born direct care workers are from Mexico, the Philippines, Jamaica, Haiti and the Dominican Republic. It is estimated that 20 percent of direct care workers are undocumented immigrants.
Obama Administration to Nominate Murthy as Surgeon General
The Obama administration plans to nominate Dr. Vivek Murthy to become the country's 19th surgeon general and the first of Indian descent. If confirmed by the Senate, Murthy would replace acting Surgeon General Rear Adm. Dr. Boris Lushniak, who assumed the interim role in July when Dr. Regina Benjamin stepped down.
Taiwanese Woman is the First Human to be Sickened by H6N1 Bird Flu
A 20-year-old woman in Taiwan has achieved the dubious distinction of being the first patient known to have been sickened by a strain of bird flu known as H6N1. The woman, who became ill in May, appears to have made a full recovery, according to a report published by the journal Lancet Respiratory Medicine. But her case raises important questions that investigators are still trying to answer, including: How did she contract the flu? And: Does this make humans more vulnerable to a bird flu pandemic?
Providers Revert to Old Techs as German Statutory Health Insurance Halts Reimbursement for NGS Tests
Molecular diagnostic labs in Germany have stopped next-generation sequencing-based testing for most patients after Germany's statutory health insurance system halted reimbursement for such tests at the beginning of October. Following the exclusion of NGS-based tests, many labs have reverted to old technology, such as single-gene Sanger sequencing, which is still covered by insurance, using it to replace multi-gene diagnostic panels for hereditary disorders or NGS-based cancer gene mutation assays for certain tumor types.
Singapore Nightclub Uses a Urinal-based Urine POCT Device to Screen Patrons’ Alcohol Levels and Discourage Drunks from Driving Themselves Home
Effort to do medical laboratory tests at point-of-care is not perfect, but the system did encourage 342 of the 573 drunks identified by the tests to take a ride home In the world of point-of-care testing (POCT), this may be the most humorous attempt to perform medical laboratory testing in an unusual setting: the men’s toilet at a night club! As part of an anti-drunk driving campaign, a nightclub in Singapore has installed urine analyzers in urinals that automatically signal management when a patron is too drunk to drive.
Wales Adopts Mass Spec-based Methodology for Newborn Sickle Cell Screening
The Wales Newborn Screening Laboratory has adopted tandem mass spectrometry for testing the country's newborns for sickle cell disease. According to Stuart Moat, the laboratory's director, mass spec-based testing offers improvements in cost and speed over HPLC and isoelectric focusing, the methods conventionally used for sickle cell screening. Additionally, Moat told ProteoMonitor, his lab's mass spec-based approach enables clinicians to identify only infants suffering from the disease, as opposed to those who are simply carriers. This, he noted, avoids passing carriers on for unnecessary follow-up testing.
The Cost-Effectiveness of Syphilis Screening and Treatment in Pregnancy in Sub-Saharan Africa
Screening and treating pregnant women in sub Saharan Africa for syphilis* may be a cost-effective use of resources, according to a study published in this week's PLOS Medicine. They found that at current syphilis prevalence rates, the intervention could prevent up to 25,000 newborn deaths of and 64,000 stillbirths in sub-Saharan Africa every year. After including the effects of syphilis on surviving babies, the authors found that screening and subsequent treatment could prevent a total of 2.6 million disability-adjusted life years (DALYs)**.
Frederick Sanger: Double Nobel Prize Winner Dies at 95
Fellow researchers have described him as "one of the greatest scientists of any generation" and as "a real hero" of British science. He is considered the "father of genomics" after pioneering methods to work out the exact sequence of the building blocks of DNA. He is the only Briton to win two Nobel Prizes and the only scientist to have been awarded the prize for Chemistry twice. The first came in 1958 for developing techniques to work out the precise chemical structure of proteins. He was awarded his second Nobel Prize in 1980 for developing "Sanger sequencing" - a technique which is still used today.
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