A Weekly Compilation of Clinical Laboratory and Related Information
From The Division Of Laboratory Systems
September 17, 2015
- Controlling Blood Sugar May Help Prevent Dementia, Study Shows
- Landmark NIH Study Shows Intensive Blood Pressure Management May Save Lives
- Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices
- FDA to Hold Workshops on Next Generation Sequencing
- Three Strategies for Making QC Management Meaningful
- How Six Immunoassays Measure Vitamin D
- Study: Alzheimer’s Pathology Might be Transmissible via Medical Procedures
- Nature: Study Creates Cell Immunity to Parasite That Infects 50 Million
- Scientists Discover Potential Biomarker for Migraine in the Blood
- New FDA Rules Tighten Requirements for Food Manufacturers
- Diabetes Nation? Half of Americans Have Diabetes or Pre-Diabetes
- 732,000: American Lives Saved by Vaccination
- Lack of Adherence to Usability Testing Standards for Electronic Health Record Products
- FBI Warns Businesses, Public about Cybercriminals Exploiting Unsecure IoT Devices
- How Home Telemedicine Can Improve Communication with Caregivers
View Previous Issues - Healthcare News Archive
Controlling Blood Sugar May Help Prevent Dementia, Study Shows
Patients with Type 2 diabetes who have poor blood-sugar control were found to have a 50% higher risk of being diagnosed with dementia
Controlling blood-sugar levels may help prevent dementia, a study released on Tuesday showed, offering hope to patients with diabetes that keeping glucose levels in check might reduce the risk of developing Alzheimer’s disease and other types of cognitive impairments. Studying 350,000 patients with Type 2 diabetes, researchers at the University of Gothenburg in Sweden found that those with poor blood-sugar control had a 50% higher risk of being admitted to hospital than those with good control. Scientists have previously suggested a link between elevated blood-sugar levels and Alzheimer’s disease, but the researchers said this was the first large-scale study looking at how controlling the presence of glucose in the blood affected the risk of being diagnosed with dementia in the future. The study, presented at the European Association for the Study of Diabetes conference in Stockholm, shows an association between the two conditions but doesn’t prove cause and effect.
Landmark NIH Study Shows Intensive Blood Pressure Management May Save Lives
More intensive management of high blood pressure, below a commonly recommended blood pressure target, significantly reduces rates of cardiovascular disease, and lowers risk of death in a group of adults 50 years and older with high blood pressure. This is according to the initial results of a landmark clinical trial sponsored by the National Institutes of Health called the Systolic Blood Pressure Intervention Trial (SPRINT). The intervention in this trial, which carefully adjusts the amount or type of blood pressure medication to achieve a target systolic pressure of 120 millimeters of mercury (mm Hg), reduced rates of cardiovascular events, such as heart attack and heart failure, as well as stroke, by almost a third and the risk of death by almost a quarter, as compared to the target systolic pressure of 140 mm Hg. “This study provides potentially lifesaving information that will be useful to health care providers as they consider the best treatment options for some of their patients, particularly those over the age of 50,” said Gary H. Gibbons, M.D., director of the National Heart, Lung, and Blood Institute (NHLBI), the primary sponsor of SPRINT.
Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices
The Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) are alerting healthcare providers and facilities about the public health need to properly maintain, clean, and disinfect or sterilize reusable medical devices. Recent infection control lapses due to non-compliance with recommended reprocessing procedures highlight a critical gap in patient safety. Healthcare facilities (e.g., hospitals, ambulatory surgical centers, clinics, and doctors’ offices) that utilize reusable medical devices are urged to immediately review current reprocessing practices at their facility to ensure they (1) are complying with all steps as directed by the device manufacturers, and (2) have in place appropriate policies and procedures that are consistent with current standards and guidelines.
Officials Weigh Who Should Be Given Ebola Vaccine, How Much to Stockpile
With scientists hopeful they are closing in on a vaccine to stop Ebola, policymakers are beginning to grapple with the other big questions — how much will be needed and who should get vaccinated in order to stem the next outbreak. It’s unlikely an Ebola vaccine will join chickenpox, measles and tetanus shots as standard for the general population, but officials will have to decide how much of the vaccine to stockpile, and whether to require mandatory vaccination for those with high-risk jobs. “The one thing that’s clear to me is that we will be vaccinating lab workers who work with Ebola,” said Dr. Cliff Lane of the National Institutes of Health, co-principal investigator on the vaccine trial in Liberia.
Laboratory Testing / Diagnostics
FDA to Hold Workshops on Next Generation Sequencing
The FDA will hold two workshops to get stakeholder input about next-generation sequencing (NGS) and how it can help advance precision medicine, two agency officials said Sept. 8 in an FDA Voice blog post. The workshops will focus on analytical performance evaluation of NGS diagnostic tests and challenges in clinical validation of these tests.
The first of the workshops, titled “Standards-Based Approach to Analytical Performance Evaluation of Next Generation Sequencing In Vitro Diagnostic Tests,” will be held Nov. 12 at the FDA White Oak campus in Silver Spring, Md. It will focus on analytical performance evaluation standards, including potential ways to develop them, which can be used by test developers to ensure that their tests produce accurate and reliable results.
The second workshop, titled “Use of Databases for Establishing the Clinical Relevance of Human Genetic Variants,” will be held Nov. 13 at the same location. The workshop will highlight how scientists, patient groups and private industry can work together to develop high-quality, curated clinical databases of genomic information that associate specific genetic changes with various diseases, such as cardiovascular disease or diabetes.
Three Strategies for Making QC Management Meaningful
Quality Control (QC) only provides value to clinical laboratories if QC failures are meaningfully managed. Too often, however, the questions asked about QC relate to the number, type, and frequency of QC required, which all are irrelevant if the lab does not deal with QC failures thoughtfully and substantively. Yet in many clinical laboratories, QC is reduced to an almost robotic process of checking off boxes to meet the specified number and frequency. Presented here are three suggestions for how laboratories can turn QC failures into more meaningful insights.
Make review of QC proactive. Taking a proactive role in QC involves routinely assessing QC before a major event brings QC failures to the leadership’s attention.
Deal with alert fatigue. An optimized false rejection rate balances the potential for alert fatigue against the possibility of accepting results that really should be rejected.
Analyze QC trends. Laboratorians should view QC failures not as isolated events, but as part of a global picture of what is occurring in the laboratory.
Employing these three strategies should make your lab’s management of QC events a meaningful part of its culture—one that helps ensure that QC events do not go unreported or ignored.
How Six Immunoassays Measure Vitamin D
Study confirms previous research that performance varies among testing methods.
A study that measured the performance characteristics of six automated 25-hydroxyvitamin D immunoassays (25(OH)D) underscored the need to standardize and align these methods. Overall, these methods underperformed when compared against mass spectrometry tests. The researchers evaluated six in all, which included one recalibrated assay from Siemens and two new assays from Beckman Coulter. Compared with the mass spectrometry methods, three of the immunoassays were affected by the presence of 25(OH)D2. Although the Beckman Coulter assays compared favorably against mass spectrometry, others did a poor job of recovering 25(OH)D in comparison with LC-MS/MS. Two of the assays, E170 and ARCHITECT, “had significant proportional, but not constant, error and significantly under-recovered in the presence of 25(OH)D2,” the study indicated. Just two of these assays met recommended bias criteria of <5%, an indication that current assay formulations are not meeting minimum quality recommendations. “Our evaluation of accuracy verified the lack of harmonization and standardization among assays, which has been discussed frequently in the academic and clinical communities,” the study’s authors noted. Clinicians should educate themselves on these differences in performance standards when using these assays to determine Vitamin D levels in their patients, the researchers advised.
Blood Test Could Replace Biopsy for Cancer Diagnosis
A simple blood test could be on the way to replacing the biopsy as the gold standard for detecting cancer, saving lives and money, according to researchers in the UK. The new study, carried out at the Royal Brompton Hospital and the UK's National Heart and Lung Institute (NHLI), at Imperial College London, involved 223 patients with known or suspected primary or secondary lung cancer who were about to undergo surgery. The researchers were not told whether the cancer was confirmed or not. In nearly 70% of cases, the blood test was accurate in predicting the presence of cancer cells.
Trovagene Develops Urine-Based Liquid Biopsy Test for Lung Cancer Patients
San Diego-based genomic laboratory Trovagene is developing an unconventional approach to liquid biopsies for lung cancer patients, relying on specimens of urine rather than blood. According to Trovagene’s research, it is able to track the DNA of circulating tumors through urine samples in patients with lung cancer. The findings are being presented at the ongoing World Conference on Lung Cancer in Denver.
FDA Clears Nanosphere's Respiratory Pathogen Test
Nanosphere announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its Verigene Respiratory Pathogens Flex test (RP Flex). The RP Flex PCR-based test features new software that allows the Verigene System to identify 16 viral and bacterial targets, either as a full multiplexed panel or in user-defined subsets.
ESMO Clinical Practice Guidelines Recommend NanoString's Prosigna Assay
NanoString Technologies announced that the European Society for Medical Oncology has added the PAM50 gene signature to its clinical practice guidelines as a prognostic and predictive tool to determine benefit from chemotherapy. NanoString's Prosigna Breast Cancer Gene Signature Assay is based on the PAM50 gene signature and runs on the firm's nCounter Dx Analysis System. The guidelines acknowledge the test has achieved an evidence level of 1B for its prognostic value, meaning its value has been demonstrated in individual randomized controlled trials.
Research and Development
Study: Alzheimer’s Pathology Might Be Transmissible via Medical Procedures
A new study suggests that the precursor of an abnormal protein that triggers Alzheimer’s disease could perhaps be transmitted from person to person through the transfer of tissue or certain specialized medical or surgical procedures, its authors said. Just as some rogue proteins can cause additional rogue proteins to form in the brain, such as the prions that produce mad cow disease, the new findings suggest that there may be a seed that carries the abnormal protein that drives Alzheimer’s disease. The paper was published in the journal Nature. But the study’s lead author took pains to emphasize that the findings do not mean that Alzheimer’s disease is contagious. Other scientists sounded even more cautious, with some expressing deep skepticism about the scope of the study and its findings. John Collinge, a professor of neurology at University College London who was the study’s lead author, emphasized that the observational study focused on a small group of people who were unwittingly infected with Creutzfeldt-Jakob disease (CJD) when they were given contaminated human-derived growth hormone as children.
Nature: Study Creates Cell Immunity to Parasite That Infects 50 Million
There are two common approaches to protecting humans from infectious disease: Targeting pathogens and parasites with medicines like antibiotics, or dealing with the conditions that allow transmission. A paper published in the journal Nature Scientific Reports demonstrates the effectiveness of a third strategy: Adjusting the landscape of the human body to remove the mechanism that allows pathogens to cause disease. The discovery is the result of serendipity and collaboration between high-level scientists in different fields. "It was pure luck that I ended up on this paper," says Dan Theodorescu, MD, PhD, director of the University of Colorado Cancer Center. Specifically, the group used the technique called RNAi to create a library of bladder cancer cells with thousands of independent, silenced genes. Then they challenged these cultures with the parasite E. histolytica. "We do this all the time in cancer research," Theodorescu says. "Commonly, we're looking for genes that, when silenced, will make cells more susceptible to chemotherapy." In this case the analogue of chemotherapy was the infectious, dangerous pathogen. "This is a major finding with translational implications for this infection that causes so many deaths worldwide, but also proof that this cancer-science approach can be used to explore genetic mechanisms of resistance in the field of infectious disease," Theodorescu says.
Scientists Discover Potential Biomarker for Migraine in the Blood
The findings of the study, published in Neurology, could have implications for the diagnosis and treatment of episodic migraine if they can be supported by further research. "While more research is needed to confirm these initial findings, the possibility of discovering a new biomarker for migraine is exciting," reports study author Dr. B. Lee Peterlin, of the Johns Hopkins University School of Medicine in Baltimore, MD. The researchers measured the body mass index (BMI) of each participant and took samples of their blood. The blood samples were analyzed for a specific group of lipids known as ceramides that have been previously identified as a group that helps regulate inflammation in the brain. Among the women with episodic migraine, the researchers found that total levels of ceramides were decreased in comparison with the women who did not report having headaches. On average, those with episodic migraines had around 6,000 nanograms per milliliter of total ceramides in their blood, compared with around 10,500 nanograms per milliliter in the blood of the control participants.
Researchers Uncover Gene Expression Signature of Healthy Aging
A signature based on the expression of 150 genes is associated with healthy aging, according to a new study. James Timmons from King's College London and his colleagues uncovered 150 probe sets that could distinguish healthy 25-year-olds from healthy 65-year-olds, as they reported in Genome Biology. After validation, they developed a healthy age gene score based on that signature, noting that higher scores were associated with better health. They also reported that their classifier could potentially be used as a diagnostic for Alzheimer's disease. While previous studies of human aging have typically focused on related diseases or extreme longevity, Timmons and his colleagues instead examined healthy 65-year-olds.These 150 probe sets could also classify young and old muscle samples from four additional datasets with an average 93 percent accuracy. Further, the researchers reported that this expression signature could also accurately classify brain and skin tissue by age, even on different platforms. "This is the first blood test of its kind that has shown that the same set of molecules are regulated in both the blood and the brain regions associated with dementia, and it can help contribute to a dementia diagnosis," Timmons said.
Sequencing Study Detects Recombination of MERS Coronavirus on Route to China
The Middle Eastern respiratory syndrome coronavirus (MERS-CoV) appears to have recombined prior to being introduced to China earlier this year, according to a genomic and phylogenetic analysis published in mBio this week. A team led by investigators at the Chinese Center for Disease Control and Prevention sequenced the genome of a MERS-CoV strain dubbed ChinaGD01 that was introduced to China in May after first reaching South Korea, where a Korean man returned home ill after visiting four Middle Eastern countries. "Based on the latest genome sequences from South Korea and the Kingdom of Saudi Arabia, our research indicated that a novel type of genetic recombination has occurred in the MERS-CoV strain prevalent in South Korea," senior authors Wenjie Tan and George Gao, at the Chinese Center for Disease Control and Prevention, and their colleagues wrote. "We note that six MERS-CoV isolates from 2015 (ChinaGD01, the first MERS-CoV strain from South Korea, and the four latest strains from Saudi Arabia) had high levels of nucleotide identity … and showed the same recombination signal in our analyses," the authors of the study concluded.
Harvard, MIT Researchers Identify 10 Million Genetic Variations in Exome
In a pathbreaking effort to identify genes associated with diseases, researchers at the Broad Institute of MIT and Harvard using data analytics have developed one of the most thorough portraits of human genetic variation, according to a report from The Atlantic. A team led by Daniel MacArthur has identified some 10 million genetic variants scattered throughout the exome, part of human genomes that harbor most of the mutations associated with diseases. In total, scientists have sequenced at least 5,000 full genomes and some 500,000 exomes, but the results were spread out and inaccessible to other researchers due to issues such intellectual-property restrictions or consent rules as well as competition among scientists, The Atlantic reported. But Broad Institute researchers were able to personally contact scientists studying the genomes of people with cancer, heart disease, diabetes, schizophrenia, and more. "There's a big swath of human genetics where people have learned that you either fail by yourself or succeed together," MacArthur said, "so they're committed to sharing data."
A Pregnancy Souvenir: Cells That Are Not Your Own
Recently a team of pathologists at Leiden University Medical Center in the Netherlands carried out an experiment that might seem doomed to failure. They collected tissue from 26 women who had died during or just after pregnancy. All of them had been carrying sons. The pathologists then stained the samples to check for Y chromosomes. Essentially, the scientists were looking for male cells in female bodies. And their search was stunningly successful. As reported last month in the journal Molecular Human Reproduction, the researchers found cells with Y-chromosomes in every tissue sample they examined. These male cells were certainly uncommon — at their most abundant, they only made up about 1 in every 1,000 cells. But male cells were present in every organ that the scientists studied: brains, hearts, kidneys and others. The new study suggests that women almost always acquire fetal cells each time they get pregnant. They have been detected as early as seven weeks into a pregnancy. In later years, the cells may disappear from their bodies, but sometimes the cells settle in for a lifetime. In a 2012 study, Dr. Nelson and her colleagues examined the brains of 59 deceased older women and found Y-chromosomes in 63 percent of them. (Many studies on fetal microchimerism focus on the cells left behind by sons, because they are easier to distinguish from the cells of their mother.)
A Novel Blood Cleaning Strategy Is Closer to Actual Use
Researchers at Harvard University’s Wyss Institute think they’ve hit on a strategy to get their unique blood-cleaning technology into clinical settings more quickly, and it was all about adopting as much existing medical technology as possible. The research team originally had a prototype that worked like a dialysis machine, according to a Wyss Institute news release. Infected blood is flowed from one vein through catheters to the device, which has magnetic beads coated with a Wyss genetically-engineered blood protein called FcMBL. The FcMBL protein is inspired by a molecule already found in the innate immune system. It binds all types of live and dead infectious microbes such as bacteria, fungi, viruses, and the toxins they release. Magnets in the original device then extracted both the FcMBL-coated beads and the pathogens stuck to them before blood was returned in another vein.
Gut Bugs May Affect Body Fat, 'Good' Cholesterol Levels
The size of your waistline may depend to some degree on the specific bacteria dwelling within your gut, new research suggests. The study, of nearly 900 Dutch adults, found that certain gut bacteria might help determine not only body fat levels, but also blood concentrations of HDL cholesterol and triglycerides. HDL is the "good" cholesterol that helps maintain a healthy heart; triglycerides are another type of blood fat that, in excess, can contribute to heart disease. This is the first study to offer "solid evidence" that gut bacteria are linked to cholesterol and triglyceride levels, said lead researcher Jingyuan Fu.
Could a Simple Supplement Halt Alzheimer’s Disease?
A cheap supplement may halt the progression of Alzheimer’s disease after a trial suggested that dementia sufferers stopped deteriorating while taking it. Resveratrol is a naturally occurring compound which is found in foods like red grapes, raspberries, dark chocolate and red wine. Scientists enrolled 119 people with mild to moderate Alzheimer’s disease in a trial in which they were given 1g of high-grade resveratrol twice a day for 12 months while a control group received a placebo. Normally, as Alzheimer’s disease progresses the level of a protein called Abeta40 decreases in the blood. But those taking the supplement showed no alteration suggesting that the disease had stabilised. They also recorded improved scores on tests which recorded how well they dressed themselves, cooked and used public transport. Sufferers who were taking the placebo continued to show decreased levels of Abeta40 and did not improve on cognitive tests. Although researchers warn that the trial is too small to advise people to start taking the supplement, they say they results are ‘very interesting’ and said further work should be done to try and replicate the findings.
Public Health and Patient Safety
New FDA Rules Tighten Requirements for Food Manufacturers
Sweeping new federal rules will require U.S.A. food manufacturers to implement more stringent food-safety operations and preventive measures to avert deadly outbreaks of foodborne illnesses like listeria and salmonella. The rules, released by the U.S. Food and Drug Administration, follow years of work by regulators amid a rash of foodborne illnesses linked to dirty food processing equipment and poorly designed facilities. The Centers for Disease Control and Prevention estimate that 48 million people — or 1 in 6 people in the United States — get sick annually from foodborne diseases, and an estimated 3,000 people die. Michael Taylor, the FDA's deputy commissioner for foods, called the new rules the most sweeping overhaul of our food safety system since the first federal law was enacted in 1906. The rules, he said, will focus on prevention, as most of the recalls consumers have faced in recent years "are largely preventable."
Diabetes Nation? Half of Americans Have Diabetes or Pre-diabetes
About half of all Americans have either diabetes or pre-diabetes, according to a new report. And experts in the field say that's good news. That's because the study finds that after two decades of linear growth, the prevalence of diabetes in the United States has finally started to plateau. In a paper published in JAMA, the authors write that their findings are consistent with other studies that show the percentage of people with diagnosed diabetes remained steady from 2008 to 2012. "Although obesity and Type 2 diabetes remain major clinical and public health problems in the United States, the current data provide a glimmer of hope," wrote William Herman and Amy Rothberg of the University of Michigan in an article accompanying the paper. Herman and Rothberg, who were not involved in the research, said the study suggests the implementation of food, nutrition and physical activity policies and regulations by federal, state and local governments as well as other efforts to curb obesity and diabetes have finally started to pay off. "Progress has been made, but expanded and sustained efforts will be required," they wrote.
732,000: American Lives Saved by Vaccination
The vaccination of children from 1994 to 2013 will prevent 732,000 early deaths in the United States, according to a recent estimate by the Centers for Disease Control and Prevention. In a report published last month, the agency announced that 90 percent of children under age 3 were vaccinated against polio, measles, mumps, rubella, hepatitis B and chickenpox in 2014. But fewer than 90 percent received DTaP — the vaccine against diphtheria, tetanus and pertussis — or the vaccines against Haemophilus influenzae Type B, pneumococcal disease, hepatitis A and rotavirus. In addition, fewer than 90 percent received the recommended hepatitis B dose at birth. About 71 percent of children received the combined vaccine series — shots containing more than one vaccine, including the DTaP (at least four doses); polio (at least three doses); measles, mumps and rubella (at least one); Haemophilus influenzae Type B (at least three or four); hepatitis B (at least three); chickenpox (at least one); and pneumococcus (at least four doses). Only 0.7 percent of children received no vaccines at all.
Adults Who Get Flu Vaccine Protect Their Parents
People often blame kids for the spread of colds and flu, but a new study shows that when adults get the flu vaccine, their parents' generation benefits. They found that people over 65 were less likely to come down with serious flu-like illness when a third of younger adults in their communities were immunized. "Our findings suggest that flu vaccination should be encouraged among low-risk adults not just for their own benefit, but also for the benefit of higher risk adults in their community, such as the elderly," said Glen Taksler of the Cleveland Clinic, who led the study. When 31 percent of younger adults in a community were vaccinated, rates of flu and related illnesses dropped by 21 percent among the people over 65, Taksler's team reported in the journal Clinical Infectious Diseases. They looked at county-by-county data for 3.3 million Medicare beneficiaries between 2002 and 2010. "In round numbers, we estimated that about one in 20 cases of influenza-related illness in the elderly could have been prevented if more non-elderly adults had received the flu vaccine," Taksler said in a statement. The Centers for Disease Control and Prevention recommends that just about everybody get vaccinated against flu, freshly each year because the immunity wears off and because the flu virus mutates.
Panel Recommends Low-Dose Aspirin for People Ages 50 to 69
Regimen prevents heart attacks, stroke and colorectal cancer, task force says
An influential federal panel recommended daily low-dose aspirin for men and women ages 50 to 69 to prevent heart attacks, stroke and colorectal cancer, setting off what is expected to be an intense debate given the drug’s side effects, including higher risk of bleeding. The recommendation is aimed at one of the biggest concerns in medicine: How to reduce risks from leading killers like heart disease, stroke and cancer. The U.S. Preventive Services Task Force’s draft recommendation said that men and women from 50 to 69 who are at increased risk of cardiovascular disease should take aspirin to prevent heart attack and stroke. The group also said people may prevent colorectal cancer by taking aspirin for 10 years or more. The benefits of aspirin are strongest in people 50 to 59, the panel said, adding that people 60 to 69 “can also benefit” after consulting their doctors.
Prostate Cancer Screening: Don't Abandon DRE, Says Expert
Screening healthy men for prostate cancer remains controversial, but if the decision is taken to undergo such screening — after detailed discussion with the individual — then both a blood test for prostate-specific antigen (PSA) and a digital rectal examination (DRE) should be carried out, says a leading expert. "Both PSA and DRE should be done," says David Penson, MD, MPH, chair of the Department of Urologic Surgery at Vanderbilt University Medical Center in Nashville, Tennessee. Dr Penson was speaking in an interview as part of a campaign to raise awareness of Prostate Health Month in September. Medscape Medical News asked specifically about the role of DRE in screening for prostate cancer, as it has been dismissed as unnecessary by one physician group. Specifically, the American Academy of Family Physicians (AAFP) states that clinicians should not "routinely screen for prostate cancer using a prostate-specific antigen test or digital rectal exam." This recommendation appears in the Academy's third Choosing Wisely List issued in September 2013.
Study Shows Ebola Mutations Can Evade Antibiotic Treatments
The deadly Ebola virus has genetic mutations, or “escape variants,” that evade the antibody-based treatments that are designed to fight infection. According to a team comprised of U.S. Army scientists as well as collaborators, this finding could impact the ongoing creation of therapeutics that are used to treat the Ebola virus. The Ebola virus infects people by overwhelming their immune system and its ability to ward away infections. One method to treat the virus is to use “cocktail” antibodies that broadly neutralize the virus, helping the immune system to make a defense. A recent candidate treatment for the virus has shown that it is ineffective in controlling the virus and helping the body. "The molecular analysis allowed us to see where the cocktails were inducing changes in the genome, and to link those changes to the treatment failure," CPT Jeffrey Kugelman, PhD, of the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), co-first author of the study, says. "When this rescued virus was sequenced, we observed that the clusters of changes had progressed from affecting a small portion of the viral population to becoming mutations—permanent changes in the genome—without disrupting any major viral functions, including the ability to cause infection."
Lack of Adherence to Usability Testing Standards for Electronic Health Record Products
The lack of adherence to usability testing standards among several widely used electronic health record (EHR) products that were certified as having met these requirements may be a major factor contributing to the poor usability of EHRs, according to a study in the September 8 issue of JAMA. Many EHRs have poor usability, leading to user frustration and safety risks. The U.S. Department of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) has established certification requirements to promote usability practices by EHR vendors as part of a meaningful use program. To develop a certified EHR, vendors are required to attest to using user-centered design (UCD), a process that places the needs of the frontline user at the forefront of software development, and to conduct formal usability testing on 8 different EHR capabilities to ensure the product meets performance objectives. “The lack of adherence to usability testing may be a major factor contributing to the poor usability experienced by clinicians. Enforcement of existing standards, specific usability guidelines, and greater scrutiny of vendor UCD processes may be necessary to achieve the functional and safety goals for the next generation of EHRs,” the authors conclude.
FBI Warns Businesses, Public about Cybercriminals Exploiting Unsecure IoT Devices
The FBI is offering some tips to both companies and the public about vulnerabilities in Internet of Things devices that cybercriminals could exploit to steal data or disrupt business, among other activities. In a public service announcement issued Sept. 10, the agency said cybercriminals can gain access to personal or business networks through deficient security on such devices as well as people's lack of awareness regarding device security. The Internet of Things, or IoT, generally refers to the vast number of devices and sensors such as home appliances, medical devices and even cars that increasingly connected to the Internet and exchange information.
How Home Telemedicine Can Improve Communication with Caregivers
Telehealth offers an ideal way to provide ongoing communication and care coordination for caregivers of patients with traumatic brain injury (TBI), a case study from the Department of Veterans Affairs illustrates, according to an article at Telemedicine and e-Health. The article tells the story of a patient, Mr. S., who was seriously injured in a stateside motor vehicle accident in 2010. After months of hospitalization and rehabilitation, he was sent home to live with his parents, who served as his caregivers, with a home exercise plan. The video visits helped the parents ensure that exercises were being done correctly, and allowed the care team to view the patient's home to address concerns about his transitions from bed to chair, to toilet, etc., by allowing them to see furniture placement, size of the doorway, availability of handrails and other factors. The parents reported being satisfied with the telehealth arrangement and asked that it remain part of their son's treatment plan.
Report: Healthcare Accounts for 21 Percent of Data Breaches Worldwide
In the first half of 2015, there were more than 245.9 million records breached worldwide--with the largest impacting consumers of health insurance company Anthem. The number of breaches so far this year has hit 888, according to a report from Breach Level Index, compared to 803 in the first half of 2014. "The healthcare industry historically has had the highest number of data breaches, and that was no different in the first half of 2015," the report's authors write.
ONC Launches Health IT Complaint Form
As more and more reports pile up cataloging provider frustrations with EHR functionality and usability, the Office of the National Coordinator has launched an online form where users can log complaints about certified products. "If you have a problem with your health IT, you should start by contacting the developer or vendor," writes Acting Deputy National Coordinator for Health IT Jon White, MD, on the ONC website. "If that doesn't work and you think the issue relates to the product's certified capability, then you should contact the ONC-Authorized Certification Body (ACB), which should be able to work with you and the developer to resolve most issues. But if the issue remains unresolved, please submit your issues to ONC."
Challenges of Interoperability Start with Defining the Term
ONC’s target date for this “learning health system” to be fully functional, as Healthcare Data Management’s Greg Slabodkin writes, is 2024 – less than a decade away. But Micky Tripathi, president and CEO of the Massachusetts eHealth Collaborative, argues that this ambitious goal and timeline obscures a critical first step without which ONC’s vision could be a pipe dream: agreeing upon a working definition of “interoperability.” “We need to get to a definition that’s much more concrete and that’s about things that are mostly focused on what can be done within networks and across networks,” he tellsHealthcare Data Management.
Mobile's Growing Connection to Health IT Interoperability
Meeting the Office of the National Coordinator for Health IT’s (ONC) goal of full interoperability in less than a decade would be a great challenge for U.S. healthcare providers under any circumstances. As mHealthIntelligence’s Vera Gruessner writes, the emergence of mobile health wearables, apps and remote monitoring tools is creating “a changing regulatory landscape, which medical providers will need to navigate in order to successfully improve patient care and health outcomes.”
Docs Share Mixed Thoughts on Google's Online Medical Data
Google recently announced it's updating its health conditions feature to cover with information on more than 900 diseases, providing quick at-a-glance info on symptoms, treatment and more. The effort will more than double the offerings in the feature, which it unveiled in February, according to a Google blog post. A recent spike in searches for information on Legionnaire's disease illustrates the kind of information people are looking for, the post, by product manager Prem Ramaswami, says. Kapil Parakh, a cardiologist and former assistant professor in the Johns Hopkins Bloomberg School of Public Health, led the effort, and Google says the information also will be checked by doctors at the Mayo Clinic.
Health IT Keeps Kaiser Permanente Providers and Patients Plugged In
Implementing Kaiser Permanente’s electronic health record was no easy task — it required about $4 billion and a great deal of effort to roll out across the organization. But Kaiser Permanente HealthConnect®, as it is known, is a notable success story: all 618 medical offices and 38 hospitals now use it; it offers more than 10 million members continuous access to their medical information, and patients report feeling more empowered to participate in their care. Patient engagement has been a primary focus for Mary Reed, DrPH, a research scientist in Kaiser Permanente’s Northern California Division of Research. Reed has spent much of the last 11 years analyzing how that engagement has changed as Kaiser Permanente has implemented its EHR. She recently discussed three of her studies, which focused on how KP HealthConnect has improved chronic disease management for providers and patients.
2 Georgia Health Systems Announce Massive Merger Plans
Two Georgia health systems — Northside Hospital and Gwinnett Medical Center — are exploring a merger to create a combined system that would have nearly 1,400 beds, more than 16,000 employees and nearly 3,500 physicians on staff. The two systems have approved a letter of intent to begin exclusive discussions to combine their operations. The leaders of the two systems said that the merger is the best way to prepare for the future needs of patients and their families. The systems are targeting early 2016 as a potential closing date for the deal.
CMS Fines Cleveland Clinic Hospital for Lab Deficiencies
A CMS inspection of Cleveland Clinic's Marymount Hospital in Garfield Heights, Ohio, found six serious violations of procedures that rose to the level of immediate jeopardy for a period of time, according to a newsnet5 report. According to an emailed statement from Cleveland Clinic, CMS selected Marymount Hospital for a Clinical Laboratory Improvement Amendments validation survey and visited the hospital in March. CMS found six issues that needed to be addressed, and put the hospital in immediate jeopardy status. The deficiencies were in the areas of handling and testing blood samples and staff competency assessment requirements, according to newsnet5. Since that time, three of the violations have been fully addressed and, as of Sept. 3, CMS took the hospital out of immediate jeopardy. However, the hospital is still out of compliance with three conditions.
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